Intravascular Lithotripsy and Impella Support to Assist Complex LM Angioplasty.
Ristalli Francesca,Maiani Silvia,Mattesini Alessio,Stolcova Miroslava,Meucci Francesco,Hamiti Brunilda,Valente Serafina,Di Mario Carlo
Cardiovascular revascularization medicine : including molecular interventions
Coronary and peripheral calcifications are associated with increased procedural complexity and suboptimal results in both coronary and peripheral percutaneous interventions. Intravascular lithotripsy (IVL) has recently entered the clinical scenario as a new technology for plaque modification, with promising results. We present a case of high risk left main (LM) percutaneous coronary intervention (PCI), in which peripheral Shockwave IVL was used to facilitate the delivery of an Impella CP via a 14 F sheath and coronary IVL was used to prepare a very calcific left main bifurcation lesion before stent deployment.
10.1016/j.carrev.2019.06.014
Six months follow-up of protected high-risk percutaneous coronary intervention with the microaxial Impella pump: results from the German Impella registry.
Baumann Stefan,Werner Nikos,Al-Rashid Fadi,Schäfer Andreas,Bauer Timm,Sotoudeh Ramin,Bojara Waldemar,Shamekhi Jasmin,Sinning Jan-Malte,Becher Tobias,Eder Frederik,Akin Ibrahim
Coronary artery disease
BACKGROUND:Percutaneous coronary intervention (PCI) represents an important alternative to coronary bypass surgery for the treatment of patients with complex coronary artery disease and high perioperative risk. Protected percutaneous coronary intervention applies temporary percutaneous ventricular assist devices to mitigate potential hemodynamic compromise in high-risk patients. The Impella system is currently the most commonly used device for protected percutaneous coronary intervention and showed improved hemodynamic parameters in earlier trials. METHODS:This study was designed as a retrospective, observational multi-center registry conducted in ten hospitals in Germany. We included consecutive patients undergoing protected high-risk percutaneous coronary intervention with Impella support. The primary endpoint was defined as the occurrence of a major adverse cardiac event defined as all-cause mortality, ST-elevation myocardial infarction, or stroke during a postprocedural 180-day follow-up period. RESULTS:In total, 157 patients (80.3% male; mean age 71.8 ± 10.8 years) were included in the present study, and 180-day follow-up was complete for 149 patients (94.9%). At baseline, the patients had a median left ventricular ejection fraction of 39.0% (interquartile range, 25.0-50.0%). The median SYNergy between PCI with TAXUS and Cardiac Surgery-Score I was 33.0 (interquartile range, 24.0-40.5) and the median EuroSCORE II was 7.2% (interquartile range, 3.2-17.1%). During postprocedural follow-up, 34 patients (22.8%) suffered a major adverse cardiac event. All-cause mortality was 18.1% (27 patients). Nine patients (6.0%) sustained a ST-elevation myocardial infarction, while 4 patients (2.7%) had a stroke. CONCLUSIONS:Patients undergoing protected high-risk percutaneous coronary intervention with Impella support showed an acceptable 180-day clinical outcome regarding major adverse cardiac event and mortality.
10.1097/MCA.0000000000000824
Prophylactic veno-arterial extracorporeal membrane oxygenation in patients undergoing high-risk percutaneous coronary intervention.
Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation
PURPOSE:Complex high-risk percutaneous coronary intervention (PCI) is challenging and frequently accompanied by haemodynamic instability. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) can provide cardiopulmonary support in high-risk PCI. However, the outcome is unclear. METHODS:A two-centre, retrospective study was performed of all patients undergoing high-risk PCI and receiving VA-ECMO for cardiopulmonary support. RESULTS:A total of 14 patients (92% male, median age 69 (53-83) years), of whom 50% had previous coronary artery disease in the form of a coronary artery bypass graft (36%) and a PCI (14%) underwent high-risk PCI and received VA-ECMO support. The main target lesion was a left main coronary artery in 78%, a left anterior descending artery in 14%, a right coronary artery in 7%, and 71% underwent multi-vessel PCI in addition to main target vessel PCI. The median SYNTAX score was 27.2 (8-42.5) and in 64% (9/14) there was a chronic total occlusion. Left ventricular function was mildly impaired in 7% (1/14), moderately impaired in 14% (2/14) and severely impaired in 64% (9/14). Cannulation was femoral-femoral in all patients. Median ECMO run was 2.57 h (1-4). Survival was 93% (13/14). One patient died during hospitalisation due to refractory cardiac failure. All other patients survived to discharge. Complications occurred in 14% (2/14), with one patient developing a transient ischaemic attack post-ECMO and one patient developing a thrombus in the femoral vein used for ECMO cannulation. CONCLUSION:VA-ECMO in high-risk PCI is feasible with a good outcome. It can be successfully used for cardiopulmonary support in selected patients.
10.1007/s12471-019-01350-8
Hybrid Robotic Impella-Assisted Single Arterial Access ComplexHigh-Risk Percutaneous Coronary Intervention.
Nagaraja Vinayak,Khatri Jaikirshan J
Cardiovascular revascularization medicine : including molecular interventions
Robotic-assisted percutaneous coronary intervention (PCI) has become popular among operators due to substantial reduction in radiation dose. Complex coronary intervention often requires mechanical support and have long fluoroscopy time. Robotic PCI offers an elegant solution by reducing operator fatigue and offering better analysis in the robotic console. We report a hybrid robotic impella assisted single arterial access complex high-risk PCI to the left anterior descending artery via the left internal mammary artery.
10.1016/j.carrev.2019.12.007
Risk/Benefit Tradeoff of Prolonging Dual Antiplatelet Therapy More Than 12 Months in TWILIGHT-Like High-Risk Patients After Complex Percutaneous Coronary Intervention.
Wang Hao-Yu,Dou Ke-Fei,Yin Dong,Xu Bo,Zhang Dong,Gao Run-Lin
The American journal of cardiology
Patients who underwent complex percutaneous coronary intervention (PCI) are known to be at high risk for both ischemic and bleeding complications. The risk/benefit tradeoff of extending dual antiplatelet therapy (DAPT) >12 months with clopidogrel and aspirin for TWILIGHT-like patients who are at high risk of bleeding or ischemic events and undergo complex PCI is unclear. Eight thousand three hundred and fifty-eight consecutive patients fulfilling the "TWILIGHT-like" criteria who underwent PCI from January 2013 to December 2013 were prospectively enrolled in Fuwai PCI Registry. We identified 2,677 of "TWILIGHT-like" complex PCI patients who were events free at 1 year after the index procedure. "TWILIGHT-like" patients were identified based on at least 1 clinical and 1 angiographic feature. Median follow-up was 29 months. Risk of primary efficacy outcome, major adverse cardiac and cerebrovascular events (composite of all-cause death, myocardial infarction, or stroke), was reduced with DAPT >12 months versus DAPT≤ 12 months (hazard ratio [HR] 0.374, 95% confidence interval [CI] 0.235 to 0.595; HR 0.292 [0.151 to 0.561]; HR 0.356 [0.225 to 0.562]), with directional consistency for cardiovascular death and definite/probable stent thrombosis. In contrast, >12-month DAPT was comparable to ≤12-month DAPT for the risk of clinically relevant bleeding ([HR] 1.189, 95% CI 0.474 to 2.984; HR 1.577 [0.577 to 4.312]; HR 1.239 [0.502 to 3.059]). Importantly, there was also a significant net benefit in favor of prolonged DAPT treatment. In conclusion, among "TWILIGHT-like" patients after complex PCI, continuing duration of DAPT> 12 months was associated with a net clinical benefit and lower rates of ischemic events without increasing the risk of clinically relevant bleeding than DAPT≤ 12 months, suggesting that long-term DAPT may have a favorable risk-benefit ratio in this high-risk population.
10.1016/j.amjcard.2020.07.033
The IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact (IMPROVE) trial: Study design and rationale.
Shlofmitz Evan,Torguson Rebecca,Mintz Gary S,Zhang Cheng,Sharp Andrew,Hodgson John McB,Shah Binita,Kumar Gautam,Singh Jasvindar,Inderbitzen Becky,Weintraub William S,Garcia-Garcia Hector M,Di Mario Carlo,Waksman Ron
American heart journal
Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent major adverse cardiovascular events after PCI. However, IVUS utilization remains low. An increasing number of high-risk or complex coronary artery lesions are treated with PCI, and we hypothesize that the impact of IVUS in guiding treatment of these complex lesions will be of increased importance in reducing major adverse cardiovascular events while remaining cost-effective. The "IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact" trial (registered on clinicaltrials.gov: NCT04221815) is a multicenter, international, clinical trial randomizing subjects to IVUS-guided versus angiography-guided PCI in a 1:1 ratio. Patients undergoing PCI involving a complex lesion are eligible for enrollment. Complex lesion is defined as involving at least 1 of the following characteristics: chronic total occlusion, in-stent restenosis, severe coronary artery calcification, long lesion (≥28 mm), or bifurcation lesion. The clinical investigation will be conducted at approximately 120 centers in North America and Europe, enrolling approximately 2,500 to 3,100 randomized subjects with an adaptive design. The primary clinical end point is the rate of target vessel failure at 12 months, defined as the composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. The co-primary imaging end point is the final post-PCI minimum stent area assessed by IVUS. The primary objective of this study is to assess the impact of IVUS guidance on the PCI treatment of complex lesions.
10.1016/j.ahj.2020.08.002
Clinical Characteristics and Outcomes From Percutaneous Coronary Intervention of Last Remaining Coronary Artery: An Analysis From the British Cardiovascular Intervention Society Database.
Shoaib Ahmad,Rashid Muhammad,Kontopantelis Evangelos,Sharp Andrew,Fahy Eoin F,Nolan James,Townend John,Ludman Peter,Ratib Karim,Azam Ziyad A,Ahmad Ayesha,McEntegart Margaret,Mohamed Mohamed,Kinnaird Tim,Mamas Mamas A,
Circulation. Cardiovascular interventions
BACKGROUND:Patients with complex high-risk coronary anatomy, such as those with a last remaining patent vessel (LRPV), are increasingly revascularized with percutaneous coronary intervention (PCI) in contemporary practice. There are limited data on the outcomes of these high-risk procedures. METHODS:We analyzed a large longitudinal PCI cohort (2007-2014, n=501 841) from the British Cardiovascular Intervention Society database. Clinical, demographic, procedural, and outcome data were analyzed by dividing patients into 2 groups; LRPV group (n=2432) and all other PCI groups (n=506 691). RESULTS:Patients in the LRPV PCI group were older, had more comorbidities, and higher prevalence of moderate-severe left ventricular systolic dysfunction. Mortality was higher in the LRPV PCI group during hospital admission (12 % versus 1.5 %, <0.001), at 30 days (15% versus 2%, <0.001), and at one-year (24% versus 5%, <0.001). In a propensity score matching analysis the adjusted risk of mortality during index admission (odds ratio, 2.05 [95% CI, 1.65-2.44], <0.001), at 30 days (odds ratio, 2.13 [95% CI, 1.78-2.5], <0.001), at 1 year (odds ratio, 1.81 [95% CI, 1.59-2.03], <0.001), and in-hospital major adverse cardiovascular events (odds ratio, 1.8 [95% CI, 1.42-2.19], <0.001) were higher in LRPV PCI group as compared to control group. In sensitivity analyses, similar clinical outcomes were observed irrespective of which major epicardial coronary artery was treated. CONCLUSIONS:In this contemporary cohort, patients who had PCI to their LRPV had a higher-risk profile and more adverse clinical outcomes, irrespective of the vessel treated.
10.1161/CIRCINTERVENTIONS.120.009049
Relationship between White Blood Count to Mean Platelet Volume Ratio and Clinical Outcomes and Severity of Coronary Artery Disease in Patients Undergoing Primary Percutaneous Coronary Intervention.
Cardiovascular therapeutics
BACKGROUND:The white blood cell count to mean platelet volume ratio (WMR) is an indicator of inflammation in patients with atherosclerotic disease. Residual SYNTAX Score (RSS) is an objective measure of degree and complexity of residual stenosis after percutaneous coronary intervention (PCI). We investigated the relationship between WMR and clinical prognosis and RSS in patients undergoing primary percutaneous coronary intervention (P-PCI). METHOD:Between June 2015 and December 2018, 537 patients who underwent primary PCI were evaluated for in-hospital events, and 477 patients were evaluated for clinical events during follow-up after discharge. The endpoint of our study is major adverse cardiac events (MACEs) seen in the in-hospital and follow-up periods. RESULTS:In our study, 537 patients were stratified into two groups according to admission median WMR. There were 268 patients in the low WMR group (WMR < 1286) and 269 patients in the high WMR group (WMR ≥ 1286). RSS ( = 0.01) value of the high WMR group was higher than that of the low WMR group. The rates of in-hospital MACE ( = 0.001), cardiac death ( < 0.001), decompansated heart failure (0.007), and ventricular tachycardia/fibrillation ( = 0.003) were higher in the high WMR group than in the low WMR group. The follow-up MACEs ( = 0.043), cardiac death ( = 0.026), and reinfarction ( = 0.031) ratio were higher in the high WMR group. In ROC analysis, cut-off values of in-hospital and follow-up MACEs were >1064 (sensitivity: 83.12%, and specificity: 36.29%) and >1130 (sensitivity: 69.15%, and specificity: 44.91%), respectively. The Kaplan-Meier analysis showed that the high WMR group had the significantly lowest MACE-free survival rate (log-rank test, = 0.006). A moderate correlation was observed between WMR and RSS (: 456, = 0.002). CONCLUSION:A higher WMR value on admission was associated with worse outcomes in patients with P-PCI and independently predicted for follow-up MACEs. The WMR provides both a rapid and an easily obtainable parameter to identify reliably high-risk patients who underwent primary percutaneous coronary intervention due to STEMI.
10.1155/2020/9625181
Procedural Characteristics and Late Outcomes of Percutaneous Coronary Intervention in the Workup Pre-TAVR.
Faroux Laurent,Campelo-Parada Francisco,Munoz-Garcia Erika,Nombela-Franco Luis,Fischer Quentin,Donaint Pierre,Serra Vicenç,Veiga Gabriela,Gutiérrez Enrique,Vilalta Victoria,Alperi Alberto,Regueiro Ander,Asmarats Lluis,Ribeiro Henrique B,Matta Anthony,Munoz-Garcia Antonio,Armijo German,Urena Marina,Metz Damien,Rodenas-Alesina Eduard,de la Torre Hernandez Jose Maria,Fernandez-Nofrerias Eduard,Pascual Isaac,Perez-Fuentes Pedro,Arzamendi Dabit,Campanha-Borges Diego Carter,Del Val David,Couture Thomas,Rodés-Cabau Josep
JACC. Cardiovascular interventions
OBJECTIVES:This study sought to determine, in patients undergoing percutaneous coronary intervention (PCI) during the work-up pre-transcatheter aortic valve replacement (TAVR): 1) the clinical and peri-procedural PCI characteristics; 2) the long-term outcomes; and 3) the clinical events in those patients with complex coronary features. BACKGROUND:A PCI is performed in about 25% of TAVR candidates, but procedural features and late outcomes of pre-TAVR PCI remain largely unknown. METHODS:Multicenter study including 1197 consecutive patients who had PCI in the work-up pre-TAVR. A total of 1,705 lesions (1.5 ± 0.7 lesions per patient) were included. Death, stroke, myocardial infarction, and major adverse cardiovascular and cerebrovascular events (MACCE) were recorded, as well as target lesion failure (TLF) and target vessel failure (TVF). RESULTS:One-half of patients exhibited a multivessel disease and the mean SYNTAX (SYNergy between PCI with TAXUS and Cardiac Surgery) score was 12.1 ± 9.1. The lesions were of B2/C type, calcified, bifurcation, and ostial in 49.9%, 45.8%, 21.4%, and 19.3% of cases, respectively. After a median follow-up of 2 (interquartile range: 1 to 3) years, a total of 444 (37.1%) patients presented an MACCE. Forty patients exhibited TVF (3.3%), with TLF identified in 32 (2.7%) patients. By multivariable analysis, previous peripheral artery disease (p < 0.001), chronic obstructive pulmonary disease (p = 0.002), atrial fibrillation (p = 0.003), diabetes mellitus (p = 0.012), and incomplete revascularization (p = 0.014) determined an increased risk of MACCE. In patients with unprotected left main or SYNTAX score >32 (n = 128), TLF, TVF, and MACCE rates were 3.9%, 6.3%, and 35.9%, respectively (p = 0.378; p = 0.065, and p = 0.847, respectively, vs. the rest of the population). CONCLUSIONS:Patients undergoing PCI in the work-up pre-TAVR frequently exhibited complex coronary lesions and multivessel disease. PCI was successful in most cases, and TLF and TVF rates at 2-year follow-up were low, also among patients with high-risk coronary features. However, overall MACCE occurred in about one-third of patients, with incomplete revascularization determining an increased risk. These results should inform future studies to better determine the optimal revascularization strategy pre-TAVR.
10.1016/j.jcin.2020.07.009
Impact of Diabetes Mellitus on Outcomes after High-Risk Interventional Coronary Procedures.
Journal of clinical medicine
An increasing number of patients with coronary artery disease are at high operative risk due to advanced age, severe comorbidities, complex coronary anatomy, and reduced ejection fraction. Consequently, these high-risk patients are often offered percutaneous coronary intervention (PCI) as an alternative to coronary artery bypass grafting (CABG). We aimed to investigate the outcome of patients with diabetes mellitus (DM) undergoing high-risk PCI. We analyzed consecutive patients undergoing high-risk PCI (period 01/2016-08/2018). In-hospital major adverse cardiac and cerebrovascular events (MACCEs), defined as in-hospital stroke, myocardial infarction and death, and the one-year incidence of death from any cause were assessed in patients with and without DM. There were 276 patients (age 70 years, 74% male) who underwent high-risk PCI. Eighty-six patients (31%) presented with DM (insulin-dependent DM: = 24; non-insulin-dependent DM: = 62). In-hospital MACCEs occurred in 9 patients (3%) with a non-significant higher rate in patients with DM ( = 5/86, 6% vs. = 4/190 2%; = 0.24). In patients without DM, the survival rate was insignificantly higher than in patients with DM (93.6% vs. 87.1%; = 0.07). One-year survival was not significantly different in DM patients with more complex coronary artery disease (SYNTAX I-score ≤ 22: 89.3% vs. > 22: 84.5%; = 0.51). In selected high-risk patients undergoing high-risk PCI, DM was not associated with an increased incidence of in-hospital MACCEs or a decreased one-year survival rate.
10.3390/jcm9113414
High-Risk "Protected" Percutaneous Coronary Intervention with Mechanical Circulatory Support in a Non-Surgical Center - An Early Asian Experience.
Li Ki Fung Cliff,Ho Hee Hwa,Jafary Fahim H,Ong Paul Jau Lueng
Acta Cardiologica Sinica
High-risk "protected" percutaneous coronary intervention (PCI) using mechanical circulatory support (MCS) devices, particularly the Impella axial pump, has emerged as a viable treatment option for high-risk patients with satisfactory clinical outcomes. High-risk and complex interventions have mostly remained within the domain of surgical centers. We report on an early "protected" PCI experience using MCS with the Impella flow pump at a high-volume PCI hospital without on-site surgery. A total of 5 patients underwent elective "protected" PCI utilizing MCS with Impella at our institution. The mean left ventricular ejection fraction was 28 ± 10% and all patients had triple vessel coronary artery disease with the majority having a high SYNTAX score. Device implantation and procedural success were achieved in all cases with no intraprocedural or access site complications. All patients were alive at 30 days and clinically well. The Impella unloads the ventricle, improves forward cardiac output and lowers myocardial oxygen demand, thereby improving mean arterial pressure and coronary perfusion. Device insertion is relatively quick and the "learning curve" is short, centering mainly around managing large bore access. Our limited experience suggests that not only is high-risk PCI with Impella support feasible in a non-surgical center, but that it may be crucial to enable success.
10.6515/ACS.202011_36(6).20200810A
Left brachial artery: one more way to percutaneous insertion of IMPELLA 2.5L circulatory support for high-risk percutaneous coronary intervention - a case report.
Sganzerla Paolo,Cinelli Francesco,Capoferri Andrea,Rondi Mauro
European heart journal. Case reports
Background:Percutaneous circulatory support allows the performance of coronary interventions in ever more complex anatomic and clinical situations. The large-bore systems currently available need a suitable vascular calibre to be inserted restricting percutaneous access mainly to the common femoral artery. Case summary:We present the case of a 64-year-old man, admitted with an acute coronary syndrome and congestive heart failure, due to triple-vessel coronary artery disease with left main involvement and left ventricular dysfunction. He was successfully treated with percutaneous coronary intervention (PCI) supported through an IMPELLA 2.5L circulatory system. Concomitant severe and diffuse peripheral vascular disease did not allow femoral insertion of the circulatory support which was therefore successfully introduced through a left brachial percutaneous approach. Discussion:To the best of our knowledge, this is the first report of a brachial, percutaneous placement of the IMPELLA 2.5L system to support a high-risk PCI procedure. In appropriately selected patients, this approach could be an option when common vascular accesses are not available.
10.1093/ehjcr/ytaa281
Feasibility and safety of minimal-contrast IVUS-guided rotational atherectomy for complex calcified coronary artery disease.
Allali Abdelhakim,Traboulsi Hussein,Sulimov Dmitriy S,Abdel-Wahab Mohamed,Woitek Felix,Mangner Norman,Hemetsberger Rayyan,Mankerious Nader,Elbasha Karim,Toelg Ralph,Richardt Gert
Clinical research in cardiology : official journal of the German Cardiac Society
OBJECTIVES:To assess the feasibility and safety of minimal-contrast percutaneous coronary intervention (PCI) using rotational atherectomy (RA) in patients with severe coronary calcification at high-risk of contrast-associated acute kidney injury (AKI). METHODS:Twenty-six patients with advanced chronic kidney disease undergoing PCI with RA at three high-volume centres were included. Baseline intravascular ultrasound (IVUS) was performed to assess lesion morphology, and to guide burr-, balloon-, and stent-selection. Final result was assessed by IVUS and angiographically. Feasibility and safety were determined by procedural and in-hospital complications, and efficacy was assessed by freedom from contrast-associated AKI after PCI. Procedural and in-hospital outcome was compared to a propensity-matched population of standard RA PCI. RESULTS:Mean glomerular filtration rate was 32 ± 17 ml/min/1.73 m. In seven cases PCI was performed in the setting of acute coronary syndrome. The left main coronary artery was treated in 27.8% and a two-stent bifurcation technique in 44.4%. RA was more often performed electively compared to the standard RA cohort (92.3 vs. 50%; p = 0.0016). Angiographic success was achieved in 100% and documented with a median contrast amount of 12.5 ml [Range 4-43]. No in-hospital death or myocardial infarction was reported. Contrast-associated AKI occurred in one patient versus five patients in standard RA group (p = 0.19). Shorter fluoroscopy time and lower radiation dose were achieved as compared to standard RA. CONCLUSION:A minimal-contrast RA approach with IVUS-guidance for treatment of complex calcified coronary lesions is feasible and safe with high success rate.
10.1007/s00392-021-01906-y
Use of the CardioHELP Device for Temporary Hemodynamic Support During High-Risk Percutaneous Coronary Intervention.
The Journal of invasive cardiology
BACKGROUND:Temporary extracorporeal membrane oxygenation (ECMO) support for high-risk percutaneous coronary intervention (PCI) has been described in select patients, and data are limited on the CardioHELP device (Maquet). The objective of this study was to assess clinical outcomes in patients undergoing elective, high-risk PCI with CardioHELP support. METHODS:Fifteen consecutive patients receiving the CardioHELP device for elective, high-risk PCI treated at 2 medical centers were included. Patients with cardiogenic shock, cardiac arrest, or non-PCI indications for ECMO were excluded. Baseline demographics, angiographic variables, procedure-related variables, and in-hospital events were collected. RESULTS:Mean age was 71 ± 11 years, 73% were male, mean ejection fraction (EF) was 29 ± 13%, 10 patients (67%) had an EF <30%, and mean SYNTAX I score was 32 ± 11. Multivessel coronary artery disease was present in 14 patients (93%) and unprotected left main coronary artery disease was present in 4 patients (27%). PCI was successful in all patients. In-hospital mortality occurred in 3 patients (20%), 7 patients (47%) received a blood transfusion, and there were no major vascular complications. CONCLUSION:Temporary use of the CardioHELP device for high-risk PCI is associated with acceptable short-term outcome and may be a new option for patients with complex coronary artery disease and left ventricular dysfunction.
10.25270/jic/20.00652
Trends in the Outcomes of High-risk Percutaneous Ventricular Assist Device-assisted Percutaneous Coronary Intervention, 2008-2018.
Lemor Alejandro,Basir Mir B,Truesdell Alexander G,Tamis-Holland Jacqueline E,Alqarqaz Mohammad,Grines Cindy L,Villablanca Pedro A,Alaswad Khaldoon,Pinto Duane S,O'Neill William
The American journal of cardiology
Percutaneous ventricular assist devices (pVAD) are frequently utilized in high-risk percutaneous coronary intervention (HR-PCI) to provide hemodynamic support in patients with complex cardiovascular disease and/or multiple comorbidities who are poor candidates for surgical revascularization. Using the National Inpatient Sample we identified pVAD-assisted PCI (excluding intra-aortic balloon pump) in patients without cardiogenic shock from January 2008 to December 2018. We evaluated the trends in patient and procedural characteristics, and complication rates across the 11-year study period. A total of 26,661 pVAD-PCI was performed. From 2008 to 2018 there has was a 27-fold increase in the number of pVAD-PCIs performed annually. There has also been an increase in the proportion of procedures performed in small to medium sized hospitals. The use of atherectomy, image-guided PCI, FFR/iFR, drug-eluting stents, and multi-vessel intervention has significantly increased. Patients undergoing pVAD-PCI had a higher burden of comorbidities, without a significant difference in mortality over time. There were decreased rates of acute stroke and blood transfusions over time, while vascular complications and acute kidney injury (AKI) requiring dialysis remained mostly unchanged. In conclusion, the use of pVAD for HR-PCI has increased significantly, along with adjunctive PCI techniques such as atherectomy, intravascular imaging, and physiologic lesion assessment. With increasing use of this device, there appeared to be lower rates of peri-procedural stroke, and blood transfusions. Despite a higher burden of comorbidities, adjusted mortality remained stable over time.
10.1016/j.amjcard.2021.06.048
[Efficacy of extracorporeal membrane oxygenation in patients with complex high risk coronary artery disease undergoing percutaneous coronary intervention].
Zhonghua xin xue guan bing za zhi
To explore the safety and efficacy of venous-arterial extracorporeal membrane oxygenation (VA-ECMO) in complex high-risk and indicated patients (CHIP). This is a single-center retrospective study. Patients who underwent percutaneous coronary intervention (PCI) supported by VA-ECMO in the Second Hospital of Jilin University from June 2018 to January 2020 were enrolled. General clinical data, laboratory examination results, PCI and ECMO process, postoperative complications and prognosis were collected through the electronic medical record system. The endpoint of the study was major adverse cardiovascular events (MACE), defined as complex events including cardiac death, recurrent myocardial infarction, heart failure and malignant arrhythmia. All patients were followed up for 12 months after discharge. Kaplan-Meier method was used for survival analysis. A total of 31 patients, aged (64.6±10.1) years, including 19 males were included. All patients were treated with VA-ECMO before PCI. The ProGlide vascular suture device was embedded by local anesthesia to quickly establish circulation. There were 9 (29.0%) patients with ST-segment elevation myocardial infarction, 10 (32.3%) patients with non-ST-segment elevation myocardial infarction and 12 (38.7%) patients with unstable angina. The number of stents implanted during the operation were 2.8±1.8. The VA-ECMO weaning time was 24.0 (2.0, 88.5) hours. Compared with the results of pre-operation, the patient's postoperative left ventricular ejection fraction was significantly improved (49% (42%, 55%) vs. 43% (35%, 52%), <0.01], hemoglobin and platelet count levels decreased, the level of creatinine and urea nitrogen was increased (<0.05). Within 24 hours after operation, hemoglobin decreased>20 g/L was observed in 18 cases (58.1%), puncture site bleeding was found in 2 cases (6.5%), pseudoaneurysm occurred in 1 case (3.2%) and postoperative cerebral infarction occurred in 1 case (3.2%). There were no deaths during the operation, 2 patients died during hospitalization. All discharged patients were followed up for 12 months. The incidence of MACE was 13.8% (4/29). During the follow-up period, 2 patients died. One patient was hospitalized with recurrent myocardial infarction and one patient with heart failure. Survival analysis was performed 12 months after intervention and the cumulative survival rate was 80.0%. The application of VA-ECMO in CHIP interventional therapy is safe, effective and feasible.
10.3760/cma.j.cn112148-20210324-00270
Antithrombotic therapy in high-risk patients after percutaneous coronary intervention; study design, cohort profile and incidence of adverse events.
Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation
BACKGROUND:Patients with multiple clinical risk factors are a complex group in whom both bleeding and recurrent ischaemic events often occur during treatment with dual/triple antithrombotic therapy after percutaneous coronary intervention. Decisions on optimal antithrombotic treatment in these patients are challenging and not supported by clear guideline recommendations. A prospective observational cohort study was set up to evaluate patient-related factors, platelet reactivity, genetics, and a broad spectrum of biomarkers in predicting adverse events in these high-risk patients. Aim of the current paper is to present the study design, with a detailed description of the cohort as a whole, and evaluation of bleeding and ischaemic outcomes during follow-up, thereby facilitating future research questions focusing on specific data provided by the cohort. METHODS:We included patients with ≥ 3 predefined risk factors who were treated with dual/triple antithrombotic therapy following PCI. We performed a wide range of haemostatic tests and collected all ischaemic and bleeding events during 6-12 months follow-up. RESULTS:We included 524 high-risk patients who underwent PCI within the previous 1-2 months. All patients used a P2Y12 inhibitor (clopidogrel n = 388, prasugrel n = 61, ticagrelor n = 75) in combination with aspirin (n = 397) and/or anticoagulants (n = 160). Bleeding events were reported by 254 patients (48.5%), necessitating intervention or hospital admission in 92 patients (17.5%). Major adverse cardiovascular events (myocardial infarction, stroke, death) occurred in 69 patients (13.2%). CONCLUSION:The high risk for both bleeding and ischaemic events in this cohort of patients with multiple clinical risk factors illustrates the challenges that the cardiologist faces to make a balanced decision on the optimal treatment strategy. This cohort will serve to answer several future research questions about the optimal management of these patients on dual/triple antithrombotic therapy, and the possible value of a wide range of laboratory tests to guide these decisions.
10.1007/s12471-021-01606-2
Double-Kissing Nano-Crush for Bifurcation PCI Guided by Live OCT Imaging: Shedding Light on Stent Positioning.
Cardiovascular revascularization medicine : including molecular interventions
Percutaneous coronary intervention (PCI) of bifurcation lesions poses unique challenges and carries a high risk of adverse events on follow-up, mainly driven by repeat revascularization and stent thrombosis. Several techniques exist to tackle bifurcation lesions. Among those, double kissing (DK) crush has emerged in recent years as a safe and effective approach for complex bifurcations requiring a two-stent strategy. In its most recent iteration, the DK nano-crush, minimal (ideally less than 3 mm) side branch stent protrusion into the main branch is recommended, to reduce the number of layers of stent struts at the ostium. Angiographic guidance of stent placement may not allow to achieve optimal positioning. Here we describe a novel approach to DK nano-crush, which employs simultaneous optical coherence tomography to facilitate optimal stent implantation at the side branch ostium.
10.1016/j.carrev.2021.10.004
High Risk Percutaneous Coronary Intervention of Left Main Bifurcation Stenosis in a Peritoneal Dialysis Patient.
Prilozi (Makedonska akademija na naukite i umetnostite. Oddelenie za medicinski nauki)
Complex coronary artery disease is the leading cause of death in patients with end-stage renal disease. We report a case of a patient on peritoneal dialysis, preloaded with Prasugrel and acetylsalicylic acid as а potent dual antiplatelet therapy (DAPT). The patient underwent a high-risk percutaneous coronary intervention (PCI) due to bifurcation stenosis of the left main stem branch. A "double kiss crush" bifurcation stenting technique was performed. This case provides additional data about the treatment of this group of patients, a group that is often excluded from randomized control trials, but is frequently encountered in cardiovascular practice. Furthermore, it helps to advance PCI treatment along with exploring the safety of potent DAPT in a group that is susceptible to both ischemia and bleeding, thus presenting a great challenge in the decision for treatment.
10.2478/prilozi-2021-0023
Clinical Characteristics and Outcomes Among Patients Undergoing High-Risk Percutaneous Coronary Interventions by Single or Multiple Operators: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.
Journal of the American Heart Association
Background High-risk percutaneous coronary intervention (HR-PCI) is increasingly common among contemporary patients with coronary artery disease. Experts have advocated for a collaborative 2-operator approach to support intraprocedural decision-making for these complex interventions. The impact of a second operator on patient and procedural outcomes is unknown. Methods and Results Patients who underwent HR-PCI from 2015 to 2018 within the Veterans Affairs Healthcare System were identified. Propensity-matched cohorts were generated to compare the outcomes following HR-PCI performed by a single or multiple (≥2) operators. The primary end point was the 12-month rate of major adverse cardiovascular events. We identified 6672 patients who underwent HR-PCI during the study period; 6211 (93%) were treated by a single operator, and 461 (7%) were treated by multiple operators, with a nonsignificant trend toward increased multioperator procedures over time. A higher proportion of patients treated by multiple operators underwent left main (10% versus 7%, =0.045) or chronic total occlusion intervention (11% versus 5%, <0.001). Lead interventionalists participating in multioperator procedures practiced at centers with higher annual HR-PCI volumes (124±71.3 versus 111±69.2; standardized mean difference, 0.197; <0.001) but otherwise performed a similar number of HR-PCI procedures per year (34.4±35.3 versus 34.7±30.7; standardized mean difference, 0.388; =0.841) compared with their peers performing single-operator interventions. In a propensity-matched cohort, there was no significant difference in major adverse cardiovascular events (32% versus 30%, =0.444) between patients who underwent single-operator versus multioperator HR-PCI. Adjusted analyses accounting for site-level variance showed no significant differences in outcomes. Conclusions Patients who underwent multioperator HR-PCI had similar outcomes compared with single-operator procedures. Further studies are needed to determine if the addition of a second operator offers clinical benefits to a subset of HR-PCI patients undergoing left main or chronic total occlusion intervention.
10.1161/JAHA.121.022131
A new iteration for the single-access large-bore technique during Impella supported complex and high-risk coronary intervention: a case report.
European heart journal. Case reports
BACKGROUND:Complex and high-risk coronary intervention (CHIP-PCI) and PCI in cardiogenic shock complicating acute coronary syndrome (ACS) are increasingly performed under mechanical circulatory support-so-called protected PCI. Among the available options, Impella Cardiac Power (CP) heart pump (Abiomed) is percutaneously inserted over the femoral artery and typically requires a second arterial access to perform PCI, which further enhances the risk of vascular and bleeding complications. The single-access technique allows Impella CP placement and PCI performance through the same vascular access. When a 7 Fr system is desirable, only a long and entirely hydrophilic coated sheath has been previously used, which is not available in Europe. CASE SUMMARY:A 85-year-old patient admitted with non ST-elevation - acute coronary syndrome (NSTE-ACS), severely reduced left ventricular function and three-vessel coronary artery disease underwent single-access CHIP-PCI under Impella CP support. After a failed attempt to insert a standard 7 Fr long femoral sheath alongside the Impella catheter, we successfully introduced a 7.5 Fr sheathless guiding catheter and delivered the planned percutaneous treatment with the benefits conferred by a 7 Fr-rather than 6-lumen catheter, without the need for an additional arterial access. DISCUSSION:This is, to the best of our knowledge, the first case of CHIP-PCI performed under Impella support utilizing the single-access technique with a 7.5 Fr sheathless guiding catheter. Beyond advantages of the single-access technique in sparing time and avoiding vascular complications associated with gaining a second arterial access, the lower outer diameter of the sheathless catheter compared with standard 7 Fr sheaths may allow improved limb perfusion and lower chance of interference with the Impella CP catheter.
10.1093/ehjcr/ytab428
Case Report: Key Role of the Impella Device to Achieve Complete Revascularization in a Patient With Complex Multivessel Disease and Severely Depressed Left Ventricular Function.
Monizzi Giovanni,Grancini Luca,Olivares Paolo,Bartorelli Antonio L
Frontiers in cardiovascular medicine
Left ventricle (LV) assist devices may be required to stabilize hemodynamic status during complex, high-risk, and indicated procedures (CHIP). We present a case in which elective hemodynamic support with the Impella CP device was essential to achieve complete revascularization with PCI in a patient with complex multivessel disease and severely depressed LV function. A 45-year-old male with no previous history of cardiovascular disease presented to the emergency department for new onset exertional dyspnoea. Echocardiography showed severely depressed LV function (EF 27%) that was confirmed with cardiac magnetic resonance. Two chronic total occlusions (CTOs) of the proximal right coronary artery (RCA) and left circumflex coronary artery (LCx) were found at coronary angiography. After Heart Team evaluation, PCI with Impella hemodynamic support was planned. After crossing and predilating the CTO of the LCx, ventricular fibrillation (VF) occurred. No direct current (DC) shock was performed because the patient was conscious thanks to the support provided by the Impella pump. About 1 min later, spontaneous termination of VF occurred. Afterwards, the two CTOs were successfully treated with good result and no complications. Recovery of LV function was observed at discharge. At 9 months, the patient had no symptoms and echocardiography showed an EF of 60%. In this complex high-risk patient, hemodynamic support was essential to allow successful PCI. It is remarkable that the patient remained conscious and hemodynamically stable during VF that spontaneously terminated after 1 min, likely because the Impella pump provided preserved coronary perfusion and LV unloading. This case confirms the pivotal role of Impella in supporting CHIP, particularly in patients with multivessel disease and depressed LV function.
10.3389/fcvm.2021.784912
Defining Percutaneous Coronary Intervention Complexity and Risk: An Analysis of the United Kingdom BCIS Database 2006-2016.
JACC. Cardiovascular interventions
OBJECTIVES:The authors used the BCIS (British Cardiovascular Intervention Society) database to define the factors associated with percutaneous coronary intervention (PCI) procedural complexity. BACKGROUND:Complex high-risk indicated percutaneous coronary intervention (CHIP-PCI) is an emerging concept that is poorly defined. METHODS:The BCIS (British Cardiovascular Intervention Society) database was used to study all PCI procedures in the United Kingdom 2006-2016. A multiple logistic regression model was developed to identify variables associated with in-hospital major adverse cardiac or cerebrovascular events (MACCE) and to construct a CHIP score. The cumulative effect of this score on patient outcomes was examined. RESULTS:A total of 313,054 patients were included. Seven patient factors (age ≥80 years, female sex, previous stroke, previous myocardial infarction, peripheral vascular disease, ejection fraction <30%, and chronic renal disease) and 6 procedural factors (rotational atherectomy, left main PCI, 3-vessel PCI, dual arterial access, left ventricular mechanical support, and total lesion length >60 mm) were associated with increased in-hospital MACCE and defined as CHIP factors. The mean CHIP score/case for all PCIs increased significantly from 1.06 ± 1.32 in 2006 to 1.49 ± 1.58 in 2016 (P < 0.001 for trend). A CHIP score of 5 or more was present in 2.5% of procedures in 2006 increasing to 5.3% in 2016 (P < 0.001 for trend). Overall in-hospital MACCE was 0.6% when the CHIP score was 0 compared with 1.2% with any CHIP factor present (P < 0.001). As the CHIP score increased, an exponential increase in-hospital MACCE was observed. The cumulative MACCE for procedures associated with a CHIP score 4+ or above was 3.2%, and for a CHIP score 5+ was 4.4%. All other adverse clinical outcomes were more likely as the CHIP score increased. CONCLUSIONS:Seven patient factors and 6 procedural factors were associated with adverse in-hospital MACCE and defined as CHIP factors. Use of a CHIP score might be a future target for risk modification.
10.1016/j.jcin.2021.09.039
Sex differences in high-risk but indicated coronary interventions (CHiP): National report from British Cardiovascular Intervention Society Registry.
Shamkhani Warkaa,Kinnaird Tim,Ludman Peter,Rashid Muhammad,Mamas Mamas A
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
OBJECTIVE:To assess sex-based differences in clinical outcomes following complex and high-risk but indicated percutaneous coronary intervention (CHiP). BACKGROUND:CHiP is increasingly common in contemporary percutaneous coronary intervention (PCI) practice. Data on sex differences in the type of CHiP procedures undertaken or their associated clinical outcomes are limited. METHODS:Patients with stable coronary artery disease who underwent CHiP between January 1, 2006, and December 31, 2017, were included. All procedures were stratified by sex. Multivariate logistic regression analyses were performed to investigate the sex-specific adjusted odds ratios (aOR) of in-hospital outcomes. RESULTS:Out of 424,290 PCI procedures, 141,610 (33.37%) were CHiP procedures. Overall, 32,129 (23%) of CHiP were undertaken in females. Females were older than males (median: 74.8 vs. 69.1 years). Males had a higher prevalence of previous myocardial infarction (MI) (44.6% vs. 35.6%) and previous PCI (40% vs. 32.5%). The most common variable observed in female patients undergoing CHiP was age >80 (35.4%), followed by prior coronary artery bypass graft (CABG) (24.3%) and severe coronary calcification (22.6%). In contrast, the most common variable in male patients was prior CABG (36%), followed by chronic thrombus occlusion (CTO) PCI (34.4%) and severe coronary calcification (22%). Females had higher odds (aOR) for mortality (aOR: 1.78, 95% CI: [1.4, 2.2]), bleeding (aOR: 1.99, 95% CI: [1.72, 3.2]), and major adverse cardiovascular and cerebral events (aOR: 1.23, 95% CI: [1.09, 1.38]) compared to males. CONCLUSION:In this national analysis of CHiP procedures over 12 years, there were significant sex differences in the type of CHiP procedures undertaken, with females at increased odds for mortality and in-hospital adverse outcomes.
10.1002/ccd.30081
Protected Percutaneous Coronary Intervention of Unprotected Left Main Using Impella Ventricular Assist Device Before Transcatheter Aortic Valve Implantation: A Single-Center Experience.
The Journal of invasive cardiology
BACKGROUND:Transcatheter aortic valve implantation (TAVI) is nowadays the optimal therapeutic strategy in patients with severe aortic valve stenosis (AS). Consequently, percutaneous coronary intervention (PCI) of concomitant complex coronary artery disease (CAD) has increased in the last decade to optimize patients with severe AS before TAVI. Although the Impella ventricular assist device (Abiomed) was considered as a relative contraindication in patients with AS, its usage has demonstrated promising results in selected patients. METHODS:All consecutive patients with severe AS who underwent staged approach with high-risk PCI of unprotected left main (ULM) using the Impella ventricular assist device before TAVI were retrospectively included. The primary endpoint was 30-day all-cause mortality, and secondary endpoints were peri-interventional mortality, vascular complication, and 30-day stroke rates. Due to the exploratory, observational intent of the study, no statistical analysis was performed. RESULTS:Twenty-one consecutive patients (14 men; age, 80 ± 6 years; log EuroScore, 17 ± 7; SYNTAX score, 27 ± 10) were included. All patients (21/21) survived to 30-day follow-up exam. Three patients (14%) had PCI of ULM and TAVI at the same session. Eighteen patients (86%) underwent TAVI in a staged approach after previous PCI (10 ± 10 days). No patient suffered from stroke up to 30-day follow-up. One patient (5%) developed Valve Academic Research Consortium-2 major vascular complication after PCI. TAVI was successfully performed in all patients. CONCLUSION:Temporary hemodynamic support with the Impella device during staged approach with high-risk protected PCI appears to be safe and technically feasible in patients with severe AS before undergoing TAVI.
10.25270/jic/21.00123
Process Standardization in High-Risk Coronary Interventions is Associated With Quality of Care Measures.
The Journal of invasive cardiology
BACKGROUND:Patient safety is one of the most important issues in healthcare. High-risk percutaneous coronary interventions (HR-PCIs) offer well-established treatment options for patients with complex coronary artery disease and multiple comorbidities. Whether process standardization using standard operating procedure (SOP) management and checklists improves HR-PCI is still unknown. METHODS AND RESULTS:This retrospective study analyzed procedural characteristics, in-hospital outcomes, and length of hospital stay in patients who received HR-PCI in a German heart center 12 months before the introduction of process standardization using SOP management-the SOP (-) group-and after the introduction of process standardization using SOP management-the SOP (+) group. A total of 192 patients were included, with 77 patients in the SOP (-) group and 115 patients in the SOP (+) group. The mean age in the SOP (-) group was 72.0 ± 10.2 years and 81.8% were male; mean age in the SOP (+) group was 75.2 ± 10.4 years and 68.7% were male. Acute kidney events were significantly lower in the SOP (+) group than in the SOP (-) group (7.0% vs 10.4%; P=.04). Bleeding was the most common adverse event and significantly lower in the SOP (+) group than in the SOP (-) group (13.1% vs 31.2%, respectively; P<.01). There were trends toward shorter length of hospital stay in the SOP (+) group compared with the SOP (-) group (9.3 ± 6.4 days vs 10.9 ± 7.3 days, respectively; P=.10) and days of hospital stay in the intensive care unit (3.7 ± 4.0 days vs 4.7 ± 4.3 days; P=.07). SOP management was independently associated with shorter length of hospital stay in multivariate regression analysis. CONCLUSION:This retrospective study shows significantly better quality of care measures after the introduction of process standardization techniques using SOP management in HRPCIs, with a lower risk of adverse outcomes and shorter length of hospital stay.
10.25270/jic/22.00065
Transcatheter treatment of severe aortic stenosis in patients with complex coronary artery disease: case series and proposed therapeutic algorithm.
European heart journal. Case reports
Background:Patients with severe aortic stenosis (AS) and complex coronary artery disease with a clinical indication to both transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) pose a clinical dilemma since it is unclear which lesion should be treated first and careful planning is required. Case summary:We report two cases of AS with complex PCI (ASCoP) features. In the first one, easy coronary cannulation with an Acurate Neo2 valve and commissural alignment was predicted; therefore, TAVI was performed first, and subsequently complex high-risk PCI of the left main was performed in the same procedure but without the burden of ongoing severe AS. In the second case, complex coronary cannulation after TAVI with an Evolut PRO valve was predicted; therefore, balloon aortic valvuloplasty and Impella placement were performed first to allow for complex, high-risk multivessel PCI and subsequent TAVI. In both cases, a single-stage approach was preferred to reduce the use of large-bore arterial access with possible consequent adverse events. Discussion:In this case series, we illustrate a possible approach to the treatment of ASCoP patients. In such complex cases, a thorough preprocedural planning is mandatory, and clinical decision-making should be centred upon the predicted chance of cannulation of coronary arteries after TAVI.
10.1093/ehjcr/ytac399
The role of optical coherence tomography in guiding percutaneous coronary interventions: is left main the final challenge?
Minerva cardiology and angiology
Left main (LM) coronary artery disease is a high-risk lesion subset, with important prognostic implications for the patients. Recent advances in the field of interventional cardiology have narrowed the gap between surgical and percutaneous approach of this complex lesion setting. However, the rate of repeat revascularization remains higher in the case of percutaneous coronary intervention (PCI) on long-term follow-up. As such, the need for better stent optimization strategies has led to the development of intravascular imaging techniques, represented mainly by intravascular ultrasound (IVUS) and optical coherence tomography (OCT). These techniques are both able to provide excellent pre- and post-PCI guidance. While IVUS is an established modality in optimizing LM PCI, and is recommended by international revascularization guidelines, data and experience on the use of OCT are still limited. This review paper deeply analyzes the current role of OCT imaging in the setting of LM disease, particularly focusing on its utility in assessing plaque morphology and distribution, vessel dimensions and proper stent sizing, analyzing mechanisms of stent failure such as malapposition and underexpansion, guiding bifurcation stenting, as well as offering a direct comparison with IVUS in this critical clinical scenario, based on the most recent available data.
10.23736/S2724-5683.22.06181-6
Effectiveness, safety, and patient reported outcomes of a planned investment procedure in higher-risk chronic total occlusion percutaneous coronary intervention: Rationale and design of the invest-CTO study.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
BACKGROUND:The anatomical complexity of a chronic total occlusion (CTO) correlates with procedural failure and complication rates. CTO modification after unsuccessful crossing has been associated with subsequent higher technical success rates, but complication rates remain high with this approach. While successful CTO percutaneous coronary intervention (PCI) has been associated with improved angina and quality of life (QOL) this has not been demonstrated in anatomically high-risk CTOs. Whether a planned CTO modification procedure, hereafter named Investment procedure, could improve patient outcomes has never been investigated. STUDY DESIGN:Invest-CTO is a prospective, single-arm, international, multicenter study, evaluating the effectiveness and safety of a planned investment procedure, with a subsequent completion CTO PCI (at 8-12 weeks), in anatomically high-risk CTOs. We will enroll 200 patients with CTOs defined as high-risk according to our Invest CTO criteria at centers in Norway and United Kingdom. Patients with aorto-ostial lesions, occlusion within a previous stent, or a prior attempt at target vessel CTO PCI within 6 months will be excluded. The co-primary endpoints are cumulative procedural success (%) after both procedures, and a composite safety endpoint at 30 days after completion CTO PCI. Patient reported outcomes (PROs), treatment satisfaction, and clinical endpoints will be reported. CONCLUSION:This study will prospectively evaluate the effectiveness and safety of a planned two staged PCI procedure in the treatment of high-risk CTOs and may have the potential to change current clinical practice.
10.1002/ccd.30692
Clinical Characteristics and Outcomes following Percutaneous Coronary Intervention in Unprotected Left Main Disease: A Single-Center Study.
Diagnostics (Basel, Switzerland)
: Hemodynamically significant unprotected left main (LM) coronary artery disease is a high-risk clinical condition because of the large area of myocardium at risk, and it requires prompt revascularization. Percutaneous coronary intervention (PCI) is an appropriate alternative to coronary artery bypass grafting (CABG) for revascularization of unprotected LM disease in patients with low-to-intermediate anatomic complexity or when the patient refuses CABG after adequate counseling by the heart team. : We retrospectively evaluated 201 patients receiving left main (LM) provisional one-stent or two-stent procedures, and we assessed the clinical characteristics and outcomes of patients undergoing unprotected LM PCI. : The mean age was 66.5 ± 9.9 years, and 72% were male. The majority of the subjects presented several cardiovascular risk factors, among which arterial hypertension (179 patients, 89.5%) and dyslipidemia (173 patients, 86.5%) were the most frequent. Out of all patients, 162 (81.8%) underwent revascularization by using the one-stent technique, while the two-stent technique was used in 36 patients (18.2%). The median value of fractional flow reserve (FFR) of the side branch was 0.9 [0.85-0.95], and 135 patients (67.1%) showed a value of FFR > 0.8. One hundred nine patients (54.2%) had a stent enhancement side branch length (SESBL) > 2, with median values of 2.5 mm [2.1-3]. Regarding angiographic parameters, the LM area as assessed by intravascular ultrasound (IVUS) or optical coherence tomography (OCT) and the grade of stenosis as assessed by quantitative coronary angiography (QCA) were similar between groups. However, patients who required revascularization by using the two-stent technique presented more frequently with intermediate rather than low SYNTAX scores (69.4% vs. 28.4%, < 0.0001). Also, the same group required kissing balloon inflation (KBI) more frequently (69.4% vs. 30%, < 0.001). There were no differences regarding the success of revascularization between the use of the one-stent or two-stent technique. FFR was able to predict a SESBL > 2 mm. The cut-off value for FFR to afford the highest degree of sensitivity (74.5%) and specificity (47%) for a SESBL > 2 was >0.86, indicating a moderate accuracy (AUC = 0.61, 95% CI 0.525-0.690, = 0.036). : Unprotected left main PCI is a safe and effective revascularization option amongst a complex and morbid population. There were no differences regarding the success of revascularization between the use of the one-stent or two-stent technique, and there was no significant impact of KBI on side branch FFR measurements but lower side branch FFR values were correlated with angiographic side branch compromise.
10.3390/diagnostics13071333
Zero-contrast IVUS-guided complex PCI in a patient with NSTE-ACS and severe renal impairment.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
A 76-year-old male with severe comorbidities and multiple cardiovascular risk factors including stage IV chronic kidney disease presents with non-ST-elevation myocardial infarction. An ultra-low contrast invasive coronary angiography using the DyeVert system and iso-osmolar contrast agent revealed a multivessel disease with heavy calcifications involving the left main stem and its bifurcation requiring a complex percutaneous coronary intervention. Because of the high risk of contrast-induced acute kidney injury, a zero-contrast intervention was performed using intravascular ultrasound guidance and dedicated stenting techniques with optimal imaging, clinical, and renal outcomes. Zero-contrast policies can be safely implemented even in complex clinical scenarios but at least two orthogonal angiographic projections should always be acquired to rule out distal complications.
10.1002/ccd.30651
Complex and high-risk intervention in indicated patients (CHIP) in contemporary clinical practice.
Cardiovascular intervention and therapeutics
Recently, there has been a growing interest in the concept of complex and high-risk intervention in indicated patients (CHIP). In our previous studies, we defined the three CHIP components (complex PCI, patient factors, and complicated heart disease), and introduced a novel stratification based on patient factors and/or complicated heart disease. We divided patients undergoing complex PCI into the definite CHIP, the possible CHIP, and the non-CHIP groups. Definite CHIP was defined as complex PCI for patients with both patient factors and complicated heart disease, and possible CHIP was defined as complex PCI for patients with either patient factors or complicated heart disease. Of note, even if a patient has both patients' factors and complicated heart disease, non-complex PCI is not a CHIP-PCI. In this review article, we discussed the determinants of complications in CHIP-PCI, long-term outcomes after CHIP-PCI, mechanical circulatory support devices for CHIP-PCI, and the goal of CHIP-PCI. Although CHIP-PCI attracts rising attention in contemporary PCI, clinical studies that investigate the clinical implications of CHIP-PCI are still sparse. Further studies are warranted to optimize CHIP-PCI.
10.1007/s12928-023-00930-1
Implementation of Robotic-Assisted Percutaneous Coronary Intervention Into a High-Risk PCI Program.
Cardiovascular revascularization medicine : including molecular interventions
BACKGROUND:How to implement robotic-assisted PCI safely and when to escalate to more complex cases has not been previously described. We sought to evaluate clinical outcomes in patients undergoing robotic-assisted PCI in the first year of a newly established robotic-assisted PCI program. METHODS:All patients who underwent robotic-assisted PCI in the first 12 months at a single academic center were included in the study. Lesion complexity was characterized as "PRECISE-like", "CORA-PCI-like", or "CORA-PCI excluded" based on established criteria. The primary outcome was clinical success, defined as <30% residual stenosis after stenting with a final TIMI flow grade 2-3 and no procedural complications. Secondary outcomes included robotic success, defined as clinical success with robotic completion, unintentional manual conversion rate, procedure time, and procedural complications. RESULTS:Of the 57 consecutive lesions treated, 12 (22.6%) had a PRECISE-like lesion complexity while 32 (56.1%) had a CORA- PCI-like, and 13 (22.8%) a CORA-PCI excluded lesion complexity. There was no significant difference in clinical success (100.0% vs. 96.7% vs. 100.0%, p = 1.00) among the groups but robotic success was numerically lower as complexity increased (100.0% vs. 80.0% vs. 72.7%, p = 0.15), with an increased frequency of manual conversion. There was no significant difference in procedural complication rates among the groups. The robotic completion rate improved during the study period. CONCLUSION:Robotic-assisted PCI, can be safely implemented in a moderate-sized academic center, with a rapid escalation in patient and lesion complexity.
10.1016/j.carrev.2022.05.022
Veno-Arterial Extracorporeal Membrane Oxygenation in Elective High-Risk Percutaneous Coronary Interventions.
Frontiers in medicine
Background:The safety and feasibility of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) as mechanical circulatory support in high-risk percutaneous coronary intervention (HR-PCI) remain unclear. Methods:This retrospective study included patients with complex and high-risk coronary artery disease who underwent elective PCI with VA-ECMO support pre-operatively during March 2019-December 2020. Rates of VA-ECMO-related complications, complications during PCI, death, myocardial infarction, and stroke during hospitalisation and 1-year post-operatively were analysed. Results:Overall, 36 patients (average age: 63.6 ± 8.9 years) underwent PCI. The average duration of VA-ECMO support was 12.5 (range, 3.0-26.3) h. Intra-aortic balloon pump counterpulsation was used in 44.4% of patients. The SYNTAX score was 34.6 ± 8.4 pre-operatively and 10.8 ± 8.8 post-operatively ( < 0.001). Intraoperative complications included pericardial tamponade ( = 2, 5.6%), acute left-sided heart failure ( = 1, 2.8%), malignant arrhythmia requiring electrocardioversion ( = 2, 5.6%), and no deaths. Blood haemoglobin levels before PCI and 24 h after VA-ECMO withdrawal were 145.4 ± 20.2 g/L and 105.7 ± 21.7 g/L, respectively ( < 0.001). Outcomes during hospitalisation included death ( = 1, 2.8%), stroke ( = 1, 2.8%), lower limb ischaemia ( = 2, 5.6%), lower limb deep venous thrombosis ( = 1, 2.8%), cannulation site haematoma ( = 2, 5.6%), acute renal injury ( = 2, 5.6%), bacteraemia ( = 2, 5.6%), bleeding requiring blood transfusion ( = 5, 13.9%), and no recurrent myocardial infarctions. Within 1 year post-operatively, two patients (5.6%) were hospitalised for heart failure. Conclusions:Veno-arterial extracorporeal membrane oxygenation mechanical circulation support during HR-PCI is a safe and feasible strategy for achieving revascularisation in complex and high-risk coronary artery lesions. VA-ECMO-related complications require special attention.
10.3389/fmed.2022.913403
The Impact of a Dedicated Chronic Total Occlusion PCI Program on Heart Team Decision Making.
The Journal of invasive cardiology
BACKGROUND:Guidelines endorse a heart team (HT) approach to standardize the decision-making process for patients with complex coronary artery disease (CAD). With percutaneous treatment options for complex CAD increasing, we hypothesized that practice had changed over the past decade-and that more individuals, previously deemed too high risk for intervention, would now be referred for either surgical or percutaneous revascularization. METHODS:This observational study was conducted at St Thomas' Hospital (London, United Kingdom). All patients discussed at HT meetings were recorded and treatment recommendations audited. A subset of historic cases was selected for blinded, repeat discussion. RESULTS:From April 2018 to 2019, a total of 52 HT meetings discussing 375 cases were held. Patients tended to be male, with a majority demonstrating multivessel CAD in the context of preserved left ventricular function. SYNTAX scores were balanced across the tertiles. Thirty-five percent of patients had at least 1 chronic total occlusion (mean J-CTO, 3 [interquartile range, 2-3]), affecting the right coronary artery in 60%. Fifteen historic patients with isolated CTOs were re-presented an average of 8 years later; only 3 patients received the same outcome, with 80% now receiving a recommendation for revascularization over medical therapy. CONCLUSIONS:A dedicated program supporting complex coronary intervention is associated with a change in treatment recommendations issued by the local HT. In line with international guidelines, this might indicate that any complex or multivessel CAD should be discussed at HT meetings with, ideally, the presence of CTO operators.
10.25270/jic/21.00447
Complex, high-risk percutaneous coronary intervention types, trends, and in-hospital outcomes among different age groups: An insight from a national registry.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
BACKGROUND:Complex, high-risk percutaneous coronary intervention (PCI) (CHiP) is increasingly being undertaken in octogenarians. However, limited data exist on CHiP types, trends, and outcomes in the octogenarian. METHODS:This is a retrospective cohort study from a national registry dataset on CHiP undertaken in patients with stable angina in England and Wales (January 2006 and December 2017) according to three age groups (group 1 [G1]: < 65 years; group 2 [G2]: 65-79 years; and group 3 [G3]: ≥80 years). RESULTS:Of 424,290 elective PCI procedures, 138,831 (33.0%) were CHiP [G1: 46,832 (33.7%); G2: 59,544 (42.9%); G3: 32,455 (23.4%)]. Among CHiP types, chronic total occlusion (CTO) (49.2%), prior coronary artery bypass graft (CABG) (30.4%), and severe vascular calcification (21.8%) were common in G1; prior CABG (42.9%), CTO (32.9%), and severe vascular calcifications (27%) were common in G2; prior CABG (15.8%), severe vascular calcification (15.5%), and chronic renal failure (11.1%) were common CHiP among the octogenarians. The older age groups had higher adjusted odds (aOR) for adverse outcomes [G2: mortality, aOR 1.7, 95% confidence interval (CI): (1.3-2.3); major bleeding, aOR 1.3, 95% CI (1.1-1.5); MACCE, aOR 1.2, 95% CI (1.0-1.3); G3: mortality, aOR 2.6, 95%CI (1.9-3.6); major bleeding, aOR 1.4, 95% CI (1.1-1.7); MACCE, aOR 1.3, 95% CI (1.1-1.5)]. CONCLUSION:There were significant differences in the types of CHiP cases undertaken and clinical outcomes across age groups.
10.1002/ccd.30366
Predictors of 30-day and 12-month mortality in left main stem percutaneous coronary intervention 2016-2020: A study from two UK centers.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
INTRODUCTION:Left main stem percutaneous coronary intervention (LMS-PCI) is a complex high-risk procedure which can be performed as an alternative to coronary artery bypass graft (CABG) procedure in surgical turn-down patients or where there is equipoise in percutaneous versus surgical strategies. Current guidelines suggest that PCI is an appropriate alternative to CABG in patients with unprotected LMS disease and low SYNTAX score. However, "real world" data on outcomes of LMS-PCI remain limited. This study aims to quantify and determine predictors of mortality following LMS-PCI. METHODS:Using local coronary angioplasty registries from two UK centers, all LMS-PCI cases were identified from 2016 to 2020. Descriptive statistics and multivariate logistic regressions were used to examine the association between baseline and procedural characteristics with 30-day and 12-month mortality. RESULTS:We identified 484 cases of LMS-PCI between 2016 and 2020. There was a year-on-year increase in the number of LMS-PCI, the highest being in 2020. Covariates associated with higher 30-day mortality were age (OR 1.07, 95% CI: 1.02-1.12) and shock preprocedure (OR 23.88, 95% CI: 7.90-72.20). Covariates associated with higher 12-month mortality were age (OR 1.04, 95% CI: 1.01-1.08), acute coronary syndrome (ACS) (OR 2.50, 95% CI: 1.08-5.80), renal disease (OR 5.24, 95% CI: 1.47-18.68), and shock preprocedure (OR 7.93, 95% CI: 3.30-19.05). Overall, 30-day and 12-month mortality in this contemporary data set were 9.5% and 16.7%, respectively, with significantly lower rates in elective cases (p < 0.01). CONCLUSIONS:Older age and cardiogenic shock preprocedure were associated with increased 30-day mortality after LMS-PCI. Twelve-month mortality was associated with older age, ACS presentation, preexisting renal disease, and cardiogenic shock preprocedure.
10.1002/ccd.30400
Intravascular Ultrasound-Guided Versus Angiography-Guided Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis.
Cureus
This meta-analysis evaluated the clinical outcomes of intravascular ultrasound (IVUS)-guided versus angiography-guided percutaneous coronary intervention (PCI) in patients with coronary artery disease (CAD). A comprehensive literature search was conducted across major electronic databases, identifying relevant studies published up to August 15, 2024. Thirteen randomized controlled trials (RCTs) met the inclusion criteria, comparing IVUS-guided and angiography-guided PCI. The primary outcomes were major adverse cardiac events (MACE) and stent thrombosis, while secondary outcomes included all-cause mortality, cardiac mortality, myocardial infarction, and revascularization rates. Pooled analysis revealed that IVUS-guided PCI significantly reduced the risk of MACE (risk ratio (RR): 0.63, 95% CI: 0.50-0.79) and stent thrombosis (RR: 0.52, 95% CI: 0.30-0.90) compared to angiography-guided PCI. Secondary outcomes also favored IVUS guidance, with significant reductions in cardiac mortality, myocardial infarction, target lesion revascularization (TLR), and target vessel revascularization (TVR). While a trend towards reduced all-cause mortality was observed with IVUS guidance, it did not reach statistical significance. Notably, low heterogeneity across studies strengthened the reliability of these findings. Meta-regression analysis indicated that the presence of myocardial infarction did not significantly moderate the effect of IVUS on clinical outcomes, suggesting consistent benefits across patient subgroups. These results highlight the potential of IVUS-guided PCI to improve cardiovascular outcomes and reduce the need for repeat procedures. The findings support the growing body of evidence favoring IVUS use in PCI, particularly in complex lesions and high-risk patients. However, considerations such as cost-effectiveness and the need for specialized training remain important factors in the widespread adoption of IVUS-guided PCI in clinical practice.
10.7759/cureus.69167
Practice differences and knowledge gaps in complex and high-risk interventions between Japan and the USA: A case-based discussion.
Journal of cardiology
Advances in percutaneous coronary intervention (PCI) devices and techniques have expanded the pool of eligible patients for revascularization, including those with comorbidities, reduced left ventricular function, or anatomical complexity (defined as CHIP: complex and high-risk interventions in indicated patients). CHIP interventions are typically performed by selected operators who specialize in complex PCI. This review presents two cases performed in the USA, to discuss the similarities and differences in practice patterns between CHIP operators in Japan and the USA. The first case involves a 58-year-old male presenting with myocardial infarction and cardiogenic shock, and the second case involves a 51-year-old female with a history of coronary artery bypass grafting presenting with a chronic total occlusion and PCI complicated by vessel perforation. The discussion focuses on appropriate patient selection, the role of the heart team approach for decision-making, the use of hemodynamic support devices, and other relevant factors. By comparing practices in Japan and the USA, this review highlights opportunities for knowledge exchange and potential areas for improving patient outcomes.
10.1016/j.jjcc.2023.10.005
The role of mechanical support devices during percutaneous coronary intervention.
JRSM cardiovascular disease
The practice of interventional cardiology has changed dramatically over the last four decades since Andreas Gruentzig carried out the first balloon angioplasty. The obvious technological improvements in stent design and interventional techniques have facilitated the routine treatment of a higher risk cohort of patients, including those with complex coronary artery disease and poor left ventricular function, and more often in the setting of cardiogenic shock (CS) complicating acute myocardial infarction (AMI). The use of mechanical cardiac support (MCS) in these settings has been the subject of intense interest, particularly over the past decade . A number of commercially available devices now add to the interventional cardiologist's armamentarium when faced with the critically unwell or high-risk patient in the cardiac catheter laboratory. The theoretical advantage of such devices in these settings is clear- an increase in cardiac output and hence mean arterial pressure, with variable effects on coronary blood flow. In doing so, they have the potential to prevent the downward cascade of ischaemia and hypoperfusion, but there is a paucity of evidence to support their routine use in any patient subset, even those presenting with cardiogenic shock. This review will discuss the use and haemodynamic effect of MCS devices during percutaneous coronary intervention (PCI), and also examine the clinical evidence for their use in patients with cardiogenic shock, and those undergoing 'high risk' PCI.
10.1177/20480040211014064
Contemporary Clinical and Coronary Anatomic Risk Model for 30-Day Mortality After Percutaneous Coronary Intervention.
Doll Jacob A,O'Donnell Colin I,Plomondon Meg E,Waldo Stephen W
Circulation. Cardiovascular interventions
BACKGROUND:Percutaneous coronary intervention (PCI) procedures are increasing in clinical and anatomic complexity, likely increasing the calculated risk of mortality. There is need for a real-time risk prediction tool that includes clinical and coronary anatomic information that is integrated into the electronic medical record system. METHODS:We assessed 70 503 PCIs performed in 73 Veterans Affairs hospitals from 2008 to 2019. We used regression and machine-learning strategies to develop a prediction model for 30-day mortality following PCI. We assessed model performance with and without inclusion of the Veterans Affairs SYNTAX score (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery), an assessment of anatomic complexity. Finally, the discriminatory ability of the Veterans Affairs model was compared with the CathPCI mortality model. RESULTS:The overall 30-day morality rate was 1.7%. The final model included 14 variables. Presentation status (salvage, emergent, urgent), ST-segment-elevation myocardial infarction, cardiogenic shock, age, congestive heart failure, prior valve disease, chronic kidney disease, chronic lung disease, atrial fibrillation, elevated international normalized ratio, and the Veterans Affairs SYNTAX score were all associated with increased risk of death, while increasing body mass index, hemoglobin level, and prior coronary artery bypass graft surgery were associated with lower risk of death. C-index for the development cohort was 0.93 (95% CI, 0.92-0.94) and for the 2019 validation cohort and the site validation cohort was 0.87 (95% CI, 0.83-0.92) and 0.86 (95% CI, 0.83-0.89), respectively. The positive likelihood ratio of predicting a mortality event in the top decile was 2.87% more accurate than the CathPCI mortality model. Inclusion of anatomic information in the model resulted in significant improvement in model performance (likelihood ratio test <0.01). CONCLUSIONS:This contemporary risk model accurately predicts 30-day post-PCI mortality using a combination of clinical and anatomic variables. This can be immediately implemented into clinical practice to promote personalized informed consent discussions and appropriate preparation for high-risk PCI cases.
10.1161/CIRCINTERVENTIONS.121.010863
Intravascular Ultrasound Guiding Percutaneous Coronary Interventions in Complex Higher Risk-Indicated Patients (CHIPs): Insight from Clinical Evidence.
Reviews in cardiovascular medicine
Intravascular ultrasound (IVUS) in percutaneous coronary intervention (PCI) has transformed the management of complex higher risk-indicated patients (CHIPs), representing a pivotal advancement in high-risk procedure navigation. IVUS, complementing conventional angiography, provides unparalleled insights into lesion characteristics, plaque morphology, and vessel structure, enhancing the precision of stent placement and postprocedural care for CHIPs. The ongoing trials underscore the pivotal role of IVUS in optimizing procedural accuracy and improving clinical outcomes for high-risk patients, promising exciting new findings. However, notable gaps persist, encompassing the absence of standardized IVUS protocols, cost implications, and limited integration into routine practice. This study aims to address these gaps comprehensively by further delineating the influence of IVUS on patient outcomes, procedural success, and long-term prognostic indicators. This review aims to provide a clear overview of IVUS-guided PCI in CHIP, highlighting the significance of ongoing trials, identifying prevalent challenges, and outlining the objective of narrowing these gaps.
10.31083/j.rcm2512443
High-Risk Chronic Total Occlusion Percutaneous Coronary Interventions Assisted With TandemHeart.
The Journal of invasive cardiology
BACKGROUND:Hemodynamic support is increasingly utilized to avoid hemodynamic collapse during high-risk chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Intermediate-term outcomes of Tandem Heart (TH)-supported CTO-PCI have not been previously reported. METHODS:We retrospectively evaluated procedural and clinical outcomes in consecutive patients undergoing TH-assisted CTO-PCI at our institution from April 1, 2016 to January 30, 2019. RESULTS:Thirteen TH-assisted CTO-PCIs (25%) were performed during the study period. TH was placed before the PCI in all procedures. The most common reason for hemodynamic support was the use of retrograde CTO-PCI technique in the setting of left ventricular dysfunction (38%). Eleven patients (92%) had decreased left ventricular function with severe congestive heart failure symptoms before the procedure. The CTO vessel treated was the right coronary artery in 38% of patients. Retrograde approach was utilized in 6 PCIs (46%). Technical success was achieved in 12 PCIs (92%) despite very complex and very difficult CTO lesions, as indicated by a median J-CTO score of 3 and Progress CTO score of 2. Procedural success was achieved in 10 patients (77%). TH was removed at the completion of PCI in 11 procedures (85%). There were no major bleeding complications; however, one patient developed arteriovenous fistula at the arterial cannula insertion site. One patient had coronary perforation with hemodynamic compromise requiring pericardiocentesis. One patient died of cardiogenic shock, secondary to right ventricular wall hematoma. CONCLUSIONS:TH can be used for hemodynamic support during CTO-PCI to achieve a very high technical success rate.
10.25270/jic/19.00333
Short-Term Outcomes of Elective High-Risk PCI with Extracorporeal Membrane Oxygenation Support: A Single-Centre Registry.
Journal of interventional cardiology
Background:If surgical revascularization is not feasible, high-risk PCI is a viable option for patients with complex coronary artery disease. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) provides hemodynamic support in patients with a high risk for periprocedural cardiogenic shock. Objective:This study aims to provide data about short-term outcomes of elective high-risk PCI with ECMO support. Methods:A retrospective single-center registry was performed on patients with high-risk PCI receiving VA-ECMO support. The short-term outcome was defined as the incidence of major adverse cardiac events (MACE) during the hospital stay and within 60 days after discharge. Results:Between January 2020 and December 2021, 14 patients underwent high-risk PCI with ECMO support. The mean age was 66.5 (±2.5) and the majority was male (71.4%) with a mean left ventricular ejection fraction of 33% (±3.0). Complexity indexes were high (STS-PROM risk score: 2.9 (IQR 1.5-5.8), SYNTAX score I: 35.5 (±2.0), SYNTAX score II (PCI): 49.8 (±3.2)). Femoral artery ECMO cannulation was performed in 13 patients (92.9%) requiring additional antegrade femoral artery cannula in one patient because of periprocedural limb ischemia. The mean duration of the ECMO run was 151 (±32) minutes. One patient required prolonged ECMO support and was weaned after 2 days. Successful revascularization was achieved in 13 patients (92.8%). Procedural success was achieved in 12 patients (85.7%) due to one unsuccessful revascularization and one procedural death. MACE during hospital stay occurred in 4 patients (28.6%) and within 60 days after discharge in 2 patients (16.7%). Conclusion:High-risk PCI with hemodynamic support using VA-ECMO is a feasible treatment option, if surgical revascularization is considered very high risk. Larger and prospective studies are awaited to confirm the benefits of ECMO support in elective high-risk PCI comparing ECMO with other mechanical circulatory support devices, including coaxial left cardiac support devices and IABP. . This trial is registered with NCT05387902.
10.1155/2022/7245384
Multidisciplinary Heart Team Approach for Complex Coronary Artery Disease: Single Center Clinical Presentation.
Journal of the American Heart Association
Background The Heart Team approach is ascribed a Class I recommendation in contemporary guidelines for revascularization of complex coronary artery disease. However, limited data are available regarding the decision-making and outcomes of patients based on this strategy. Methods and Results One hundred sixty-six high-risk coronary artery disease patients underwent Heart Team evaluation at a single institution between January 2015 and November 2018. We prospectively collected data on demographics, symptoms, Society of Thoracic Surgeons Predicted Risk of Mortality/Synergy Between PCI with Taxus and Cardiac Surgery (STS-PROM/SYNTAX) scores, mode of revascularization, and outcomes. Mean age was 70.0 years; 122 (73.5%) patients were male. Prevalent comorbidities included diabetes mellitus (51.8%), peripheral artery disease (38.6%), atrial fibrillation (27.1%), end-stage renal disease on dialysis (13.3%), and chronic obstructive pulmonary disease (21.7%). Eighty-seven (52.4%) patients had New York Heart Association III-IV and 112 (67.5%) had Canadian Cardiovascular Society III-IV symptomatology. Sixty-seven (40.4%) patients had left main and 118 (71.1%) had 3-vessel coronary artery disease. The median STS-PROM was 3.6% (interquartile range 1.9, 8.0) and SYNTAX score was 26 (interquartile range 20, 34). The median number of physicians per Heart Team meeting was 6 (interquartile range 5, 8). Seventy-nine (47.6%) and 49 (29.5%) patients underwent percutaneous coronary intervention and coronary artery bypass grafting, respectively. With increasing STS-PROM (low, intermediate, high operative risk), coronary artery bypass graft was performed less often (47.9%, 18.5%, 15.2%) and optimal medical therapy was recommended more often (11.3%, 18.5%, 30.3%). There were no trends in recommendation for coronary artery bypass graft, percutaneous coronary intervention, or optimal medical therapy by SYNTAX score tertiles. In-hospital and 30-day mortality was 3.9% and 4.8%, respectively. Conclusions Integrating a multidisciplinary Heart Team into institutional practice is feasible and provides a formalized approach to evaluating complex coronary artery disease patients. The comprehensive assessment of surgical, anatomical, and other risk scores using a decision aid may guide appropriate, evidence-based management within this team-based construct.
10.1161/JAHA.119.014738
Chronic total occlusion revascularization: A complex piece to "complete" the puzzle.
Muraca Iacopo,Carrabba Nazario,Virgili Giacomo,Bruscoli Filippo,Migliorini Angela,Pennesi Matteo,Pontecorboli Giulia,Marchionni Niccolò,Valenti Renato
World journal of cardiology
Treatment of coronary chronic total occlusion (CTO) with percutaneous coronary intervention (PCI) has rapidly increased during the past decades. Different strategies and approach were developed in the recent past years leading to an increase in CTO-PCI procedural success. The goal to achieve an extended revascularization with a high rate of completeness is now supported by strong scientific evidences and consequently, has led to an exponential increase in the number of CTO-PCI procedures, even if are still underutilized. It has been widely demonstrated that complete coronary revascularization, achieved by either coronary artery bypass graft or PCI, is associated with prognostic improvement, in terms of increased survival and reduction of major adverse cardiovascular events. The application of "contemporary" strategies aimed to obtain a state-of-the-art revascularization by PCI allows to achieve long-term clinical benefit, even in high-risk patients or complex coronary anatomy with CTO. The increasing success of CTO-PCI, allowing a complete or reasonable incomplete coronary revascularization, is enabling to overcome the last great challenge of interventional cardiology, adding a "complex" piece to "complete" the puzzle.
10.4330/wjc.v14.i1.13
Complex High-Risk Indicated Percutaneous Coronary Intervention With Prophylactic Use of the Impella CP Ventricular Assist Device.
The Journal of invasive cardiology
OBJECTIVES:Patients with complex coronary artery disease, concomitant cardiac disease, and multiple comorbidities are addressed as complex higher-risk indicated patients (CHIPs). Selecting a revascularization strategy in this population remains challenging. If coronary artery bypass grafting is deemed high risk or patients are considered inoperable, high-risk percutaneous coronary intervention (PCI) with the support of the Impella CP ventricular assist device (Abiomed) may be an attractive alternative. METHODS:In this retrospective, multicenter study, we included consecutive patients undergoing Impella CP-facilitated complex high-risk PCI. All patients were discussed by the heart team and were declined for surgery. Additionally, periprocedural mechanical circulatory support was deemed necessary. We collected demographic, clinical, and procedural characteristics. Major adverse cardiac event (MACE) and mortality rates up to 30 days were evaluated. RESULTS:A total of 27 patients (median age, 73 ± 9.7 years; 74.1% men) were included in our study. The median SYNTAX score was 32 (range, 8-57) and EuroSCORE was 7.25% (range, 1.33-49.66; ± 12.76%). Periprocedural hemodynamic instability was observed in 1 patient (3.7%). In-hospital combined with 30-day mortality was 7.4% (2/27). No repeat revascularization was necessary. MACE was observed in 10 patients (37.0%). Six patients (22.2%) had a major bleeding complication, of which 2 were related to Impella access site. Median Impella run time was 1.22 hours and there was no significant decrease in kidney function. Median admission time after PCI was 3 days (range, 1-23; ± 4.76). CONCLUSIONS:The Impella CP system showed good feasibility and provided adequate hemodynamic support during high-risk PCI in this CHIP population.
10.25270/jic/22.00031
A Novel Risk Score to Predict One-Year Mortality in Patients Undergoing Complex High-Risk Indicated Percutaneous Coronary Intervention (CHIP-PCI).
The Journal of invasive cardiology
OBJECTIVE:To identify patients undergoing complex, high-risk indicated percutaneous coronary intervention (CHIP-PCI) and compare their outcomes with non-CHIP patients. We created a CHIP score to risk stratify these patients. BACKGROUND:Risk stratification of PCI patients remains difficult because most scoring systems reflect hemodynamic instability and predict early mortality. METHODS:CHIP-PCI was defined as any of the following: age >80 years; ejection fraction <30%; dialysis; prior bypass surgery; treatment of left main trunk; chronic total occlusion; or >2 lesions in >1 coronary artery. The primary endpoint was 1-year all-cause mortality. Logistic regression identified independent predictors of 1-year mortality and the odds ratios (ORs) for those predictors were used to create a CHIP score. Patients were then classified as low, intermediate, and high risk. RESULTS:Among 4478 patients, a total of 1730 (38.6%) were CHIP. There were 85 deaths (2.2%) at 1 year (4.1% in CHIP patients and 1.0% in non-CHIP patients; P<.001). CHIP-PCI was an independent predictor of mortality (OR, 2.57; 955 confidence interval, 1.52-4.32; P<.001). Four CHIP criteria were independent predictors of mortality: age >80 years (3 points); dialysis (6 points); ejection fraction <30% (2 points); and number of lesions treated >2 (2 points). Accordingly, there were 2752 low-risk (score of 0), 889 intermediate-risk (score of 2-3), and 267 high-risk patients (score of 4-13). The 1-year mortality rates among these 3 groups were 1.24%, 2.47%, and 10.86%, respectively (P<.001). CONCLUSION:Compared with non-CHIP, CHIP-PCI is associated with increased risk of 1-year mortality, which is particularly evident among those fulfilling >1 CHIP criterion.
10.25270/jic/20.00515
Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting for Revascularization of Left Main Coronary Artery Disease.
Korean circulation journal
Owing to a large-jeopardized myocardium, left main coronary artery disease (LMCAD) represents the substantial high-risk anatomical subset of obstructive coronary artery disease. For several decades, coronary artery bypass grafting (CABG) has been the "gold standard" treatment for LMCAD. Along with advances in CABG, percutaneous coronary intervention (PCI) has also dramatically evolved over time in conjunction with advances in the stent or device technology, adjunct pharmacotherapy, accumulated experiences, and practice changes, establishing its position as a safe, reasonable treatment option for such a complex disease. Until recently, several randomized clinical trials, meta-analyses, and observational registries comparing PCI and CABG for LMCAD have shown comparable long-term survival with tradeoffs between early and late risk-benefit of each treatment. Despite this, there are still several unmet issues for revascularization strategy and management for LMCAD. This review article summarized updated knowledge on evolution and clinical evidence on the treatment of LMCAD, with a focus on the comparison of state-of-the-art PCI with CABG.
10.4070/kcj.2022.0333
Percutaneous Treatment of Left Main Disease: A Review of Current Status.
Journal of clinical medicine
Percutaneous treatment of the left main coronary artery is one of the most challenging scenarios in interventional cardiology, due to the large portion of myocardium at risk the technical complexity of treating a complex bifurcation with large branches. Our aim is to provide un updated overview of the current indications for percutaneous treatment of the left main, the different techniques and the rationale underlying the choice for provisional versus upfront two-stent strategies, intravascular imaging and physiology guidance in the management of left main disease, and the role of mechanical support devices in complex high-risk PCI.
10.3390/jcm12154972
Association of Preprocedural SYNTAX Score With Outcomes in Impella-Assisted High-Risk Percutaneous Coronary Intervention.
Journal of the Society for Cardiovascular Angiography & Interventions
Background:Patients with complex coronary artery disease, as defined by high SYNTAX scores, undergoing percutaneous coronary intervention (PCI) have poorer outcomes when compared with patients with lower SYNTAX I scores. This study aimed to assess if mechanical circulatory support using Impella mitigates the effect of the SYNTAX I score on outcomes after high-risk percutaneous coronary intervention (HRPCI). Methods:Using data from the PROTECT III study, patients undergoing Impella-assisted HRPCI between March 2017 and March 2020 were divided into 3 cohorts based on SYNTAX I score-low (≤22), intermediate (23-32), and high (≥33). Procedural and clinical outcomes out to 90 days were compared between groups. Multivariable regression analysis was used to assess the impact of SYNTAX I score on major adverse cardiovascular and cerebrovascular events (MACCE) at 90 days. Results:A total of 850 subjects with core laboratory-adjudicated SYNTAX I scores were identified (low: n = 310; intermediate: n = 256; high: n = 284). Patients with high SYNTAX I scores were older than those with low or intermediate SYNTAX I scores (72.7 vs 69.7 vs 70.1 years, respectively; < .01). After adjustment for covariates, high SYNTAX I score remained a significant predictor of 90-day MACCE (hazard ratio [HR], 2.14; 95% CI, 1.42-3.69; < .01 vs low), whereas intermediate SYNTAX I score was not (HR, 0.92; 95% CI, 0.47-1.77; = .80 vs low). These findings persisted after adjustment for post-PCI SYNTAX I score. Conclusions:A high SYNTAX I score was associated with higher rates of 90-day MACCE in patients who underwent Impella-assisted HRPCI. Further research is needed to understand the patient and procedural factors driving this finding.
10.1016/j.jscai.2024.101981
High On-Treatment Platelet Reactivity in Patients Undergoing Complex Percutaneous Coronary Interventions.
Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
Patient response to P2Y12 inhibitor therapy is heterogeneous, and those with high on-treatment platelet reactivity (HTPR) are at an increased risk of thrombotic complications. The aim of our study was to determine whether selecting a high-risk patient group of individuals after complex percutaneous coronary intervention (PCI) would show the clinical benefit of HTPR testing for preventing thrombotic complications. Blood samples of patients after complex PCI were acquired 1 day and 1 month after the intervention. The samples were tested using vasodilator-stimulated phosphoprotein phosphorylation (VASP-P) and platelet function assay (PFA). The occurrence of clinically significant stent thrombosis with repeated revascularization of the target vessel was observed over a 1-year period. One day after PCI, 37% of patients had HTPR as established by VASP-P. One month after PCI, the percentage of patients with HTPR decreased to 30.9%. According to PFA, 1 day after PCI, 33.3% of patients had HTPR. This percentage declined to 19.8% after 1 month. All measurements identified a significantly higher proportion of HTPR in patients on clopidogrel compared to ticagrelor and prasugrel. Two cases of early stent thrombosis and 1 case of late stent thrombosis were identified. Further study of adenosine diphosphate receptor blocker on-treatment response in patients undergoing complex PCI is necessary.
10.1177/10760296231199089
Coronary anatomy and comorbidities impact on elective PCI outcomes in left main and multivessel coronary artery disease.
Yager Neil,Schulman-Marcus Joshua,Torosoff Mikhail
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
INTRODUCTION:The effects of coronary anatomy, lesion complexity, and comorbidities on outcomes of elective percutaneous coronary intervention (PCI) in high-risk patients with left main (LM) and/or multivessel coronary artery disease (CAD) are not well studied, as these patients are typically underrepresented in the clinical trials. METHODS:This cohort study involved 33,568 consecutive elective PCI cases, excluding patients with prior coronary artery bypass graft, acute coronary syndrome within 24 hr of index PCI, or shock. All data were obtained from the New York State's PCI Reporting System from the calendar year 2015. In-hospital mortality was the primary outcome of study. Logistic regression models were built to calculate odds ratios (OR) with 95% confidence intervals (CI) for in-hospital mortality after adjustment for coronary anatomy and significant clinical comorbidities. RESULTS:In this cohort of elective PCI cases all cause in-hospital mortality was low (0.3%), with a clear mortality gradient according to the extent of CAD: 0.1% in 1 vessel disease, 0.4% in 2 vessel, 0.5% in 3 vessel disease, and 3.2% in patients with LM CAD (p < .001). Mortality was also significantly increased in patients with multiple comorbidities: 0.1% in patients with 1 comorbidity, 0.7% with 2, 2.5% with 3, and 7.4% with 4 or more studied comorbidities (p < .0001). When adjusted for coronary anatomy and lesion complexity, having any 4 or more comorbidities was associated with significantly increased odds of dying after elective PCI (OR 25.9, 95% CI 8.152-82.063, p < .0001). Furthermore, when compared to patients with 3-vessel CAD, and accounted for comorbidities, the patients with LM disease still had significantly increased (OR 5.254, 95% CI 3.104-8.891, p < .0001) odds of dying after elective PCI. CONCLUSIONS:In patients undergoing elective PCI, multivessel CAD and particularly LM disease are associated with significantly increased all-cause mortality. Furthermore, when adjusted for the extent of CAD and lesion complexity, comorbidity burden remains an important predictor of mortality.
10.1002/ccd.29368
Feasibility and Effectiveness of Venoarterial Extracorporeal Membrane Oxygenation Plus Intra-Aortic Balloon Pump Assisted High-Risk Percutaneous Coronary Intervention in Complex Coronary Disease.
Acta Cardiologica Sinica
Background:Mechanical circulatory support may facilitate high-risk percutaneous coronary intervention (PCI). This study aimed to assess the feasibility, safety and effectiveness of high-risk PCI under the support of venoarterial extracorporeal membrane oxygenation (VA-ECMO) combined with intra-aortic balloon pump (IABP). Methods:We enrolled patients who received VA-ECMO plus IABP-assisted PCI procedures at our center from April 2012 to June 2018. Major adverse cardiac events (MACEs) included all-cause death, myocardial infarction, and target vessel revascularization. Results:A total of 10 patients were included, with a mean age of 71 years, EuroSCORE II of 19.9%, and SYNTAX score of 39.8. Procedural success was achieved in nine (90%) patients. The mean duration of ECMO support was 1.5 hours, and 2.6 stents were implanted per patient. Major complications included contrast-induced nephropathy needing hemodialysis in one (10%) patient, significant hemoglobin drop requiring blood transfusion in two (20%) patients, pulmonary infection in one (10%) patient, and local surgical incision infection in one (10%) patient. The accumulative mortality rates for the nine patients with procedural success were 0, 22.2%, and 44.4% at 1, 3, and 5 years follow-up, respectively. However, cardiac death occurred in only one (11.1%) patient. In addition, two patients received repeat PCI or coronary artery bypass grafting within two years following the index procedure. The overall incidence rates of MACEs were 11.1%, 44.4%, and 66.7% at 1, 3, and 5 years follow-up, respectively. Conclusions:VA-ECMO plus IABP-assisted high-risk PCI was feasible in patients with complex coronary disease, with a high procedural success rate and acceptable mid-term clinical outcomes.
10.6515/ACS.202409_40(5).20240617F
Prognostic Capability of Clinical SYNTAX Score in Patients with Complex Coronary Artery Disease and Chronic Renal Insufficiency Undergoing Percutaneous Coronary Intervention.
Reviews in cardiovascular medicine
Background:The SYNTAX score (SS) is useful for predicting clinical outcomes in patients undergoing percutaneous coronary intervention (PCI). The clinical SYNTAX score (CSS), developed by combining clinical parameters with the SS, enhances the risk model's ability to predict clinical outcomes. However, prior research has not yet evaluated the prognostic capacity of CSS in patients with complex coronary artery disease (CAD) and chronic renal insufficiency (CRI) who are undergoing PCI. We aimed to demonstrate the prognostic potential of CSS in assessing long-term adverse events in this high-risk patient cohort. Methods:A total of 962 patients with left main and/or three-vessel CAD and CRI were enrolled in the study spanning from January 2014 to September 2017. The CSS was calculated by multiplying the SS by the modified age, creatinine, and left ventricular ejection fraction (ACEF) score (age/ejection fraction + 1 for each 10 mL of creatinine clearance 60 mL/min per 1.73 ). The patients were categorized into three groups based on their CSS values: low-CSS group (CSS 18.0, n = 321), mid-CSS group (18.0 CSS 28.3, n = 317), and high-CSS group (CSS 28.3, n = 324) as per the tertiles of CSS. The primary endpoints were all-cause mortality (ACM) and cardiac mortality (CM). The secondary endpoints included myocardial infarction (MI), unplanned revascularization, stroke, and major adverse cardiac and cerebrovascular events (MACCE). Results:At the median 3-year follow-up, the high-CSS group exhibited higher rates of ACM (19.4% vs. 6.6% vs. 3.6%, 0.001), CM (15.6% vs. 5.1% vs. 3.2%, = 0.003), and MACCE (33.8% vs. 29.0% vs. 20.0%, = 0.005) in comparison to the low and mid-CSS groups. Multivariable Cox regression analysis revealed that CSS was an independent predictor for all primary and secondary endpoints ( 0 .05). Moreover, the C-statistics of CSS for ACM (0.666 vs. 0.597, = 0.021) and CM (0.668 vs. 0.592, = 0.039) were significantly higher than those of SS. Conclusions:The clinical SYNTAX score substantially enhanced the prediction of median 3-year ACM and CM in comparison with SS in complex CAD and CRI patients following PCI.
10.31083/j.rcm2501018
Outcomes Prediction in Complex High-Risk Indicated Percutaneous Coronary Interventions in the Older Patients.
The American journal of cardiology
Complex high-risk indicated percutaneous coronary intervention (CHIP-PCI) is a poorly defined concept, which has not been validated in an older population before. This study aimed to evaluate the predictive value of the CHIP-PCI score in a large cohort of elderly patients and to identify potential further risk factors. This is a pooled analysis of 3 registries that included patients aged ≥75 years who underwent percutaneous coronary intervention from 2012 to 2019: the multicenter prospective EPIC05-Sierra 75 study, the multicenter retrospective PACO-PCI (EPIC-15) registry, and the single-center, prospective Elderly-HCD registry. A total of 2,725 patients with a mean age of 81 ± 4 years were included in the study; 269 patients (10%) met the primary end point of 1-year major adverse cardiac and cerebrovascular events (MACCEs), and 51 patients (2%) had in-hospital MACCEs. Of the 12 investigated original CHIP-PCI score variables, 5 were independent predictors: previous myocardial infarction, left ventricular ejection fraction <30%, chronic kidney disease, left main coronary artery percutaneous coronary intervention, and nonradial access. Furthermore, diabetes mellitus, anemia, and severe calcification showed to be significant predictors of MACCEs. The additional variables improved the discriminatory value of the CHIP-PCI score for 1-year MACCEs (modified CHIP-PCI score: area under the curve [AUC] 0.647 vs original CHIP-PCI score: AUC 0.598, p = 0.02) and in-hospital MACCEs (AUC 0.729 vs 0.657, p = 0.003, respectively). In conclusion, the CHIP-PCI score retains its prognostic value in older patients for in-hospital MACCEs; however, it is of limited value at 1-year follow-up. The modified CHIP-PCI score, including the 5 patient-related and 3 procedure-related factors, significantly improved its discriminatory potential.
10.1016/j.amjcard.2023.07.166
Roadmap towards an institutional Impella programme for high-risk coronary interventions.
ESC heart failure
Coronary artery disease (CAD) and its complications remain the main cause of morbidity and mortality worldwide. Patients with extensive CAD and multiple comorbidities who require complex, high-risk percutaneous coronary intervention (HR-PCI) are at risk of haemodynamic instability and may require short-term mechanical circulatory support (MCS) during the procedure to maintain sufficient perfusion and prevent ischaemia. Impella is a microaxial continuous blood flow pump used for percutaneous support of the left ventricle in patients undergoing HR-PCI. Data from randomized controlled trials and registries suggested an advantage for Impella devices in patients undergoing HR-PCI, compared with other types of MCS. As a thorough understanding of the benefits and drawbacks of the Impella technology is crucial for patient outcomes, we provide a technological overview of Impella and share our experiences gathered during the implementation of institutional Impella programmes in Poland as a roadmap of selection and periprocedural care for patients treated with Impella in the setting of HR-PCI. We propose 10 steps for implementation of an institutional Impella programme for HR-PCI, including (i) dedicated staff training; (ii) standard operating procedure and troubleshooting algorithms prior to the first intervention; (iii) patient selection by the multidisciplinary Heart Team; (iv) patient preparation using multimodality imaging; (v) procedure planning in terms of large-bore access, equipment, and complete revascularization; (vi) starting with HR-PCI support; (vii) starting with femoral artery access in a patient without extensive peripheral artery disease; (viii) multidisciplinary care after the procedure; (ix) haemodynamic and laboratory monitoring to ensure immediate diagnosis of access-site complications, bleeding, haemolysis, acute kidney injury, and infections; and (x) careful revision of every HR-PCI case with the team.
10.1002/ehf2.14397
Clinical Outcomes and Predictors of All-Cause Mortality After Complex High-Risk and Indicated Revascularization Using Percutaneous Coronary Intervention.
International heart journal
The concept of complex and high-risk indicated procedures using percutaneous coronary intervention (CHIP-PCI) has recently been defined. However, few studies have investigated the prognosis of patients after CHIP-PCI. We enrolled 322 consecutive patients who underwent CHIP-PCI. CHIP-PCI was defined as a procedure satisfying at least one criterion each for both patient and procedure characteristics, as follows: patient characteristics [age ≥ 75 years old, low left ventricular ejection fraction (LVEF), diabetes mellitus, acute coronary syndrome, previous coronary artery bypass surgery, peripheral arterial disease, severe chronic kidney disease (CKD), chronic obstructive pulmonary disease (COPD), and severe valvular disease] and procedure characteristics [unprotected left main disease, degenerated saphenous or radial artery grafts, severely calcified lesions, last patent conduit, chronic total occlusions, multivessel disease, and use of mechanical circulatory support]. On Kaplan-Meier analysis, 1-, 2-, and 3-year survival rates following CHIP-PCI was 93.8%, 89.2%, and 85.4%, respectively. Moreover, on Cox multivariate hazard analysis, age (≥ 75 years old) (hazard ratio: 4.01, 95% confidence interval: 1.92-8.38, P < 0.01), COPD (hazard ratio: 2.95, 95% confidence interval: 1.38-6.32, P < 0.01), low LVEF (hazard ratio: 3.35, 95% confidence interval: 1.55-7.22, P < 0.01), severe CKD (hazard ratio: 3.02, 95% confidence interval: 1.44-6.36, P < 0.01), and use of mechanical circulatory support (hazard ratio: 5.97, 95% confidence interval: 2.72-13.10, P < 0.01) remained significant predictors of mortality. In conclusion, we revealed the clinical outcomes after CHIP-PCI. The presence of advanced age, COPD, low LVEF, severe CKD, and mechanical circulatory support use might lead to worse clinical outcomes.
10.1536/ihj.22-710
Revascularization strategies for left main coronary artery disease: current perspectives.
Elbatarny Malak,Cheema Asim N,Mazine Amine,Verma Subodh,Yanagawa Bobby
Current opinion in cardiology
PURPOSE OF REVIEW:Left main coronary artery disease (LMCAD) represents a high-risk subset of coronary artery disease with significant morbidity and mortality if not treated in a timely manner. In this review, we survey the contemporary evidence on the management of LMCAD, highlight advances, and provide in-depth review of data comparing surgical and percutaneous approaches. RECENT FINDINGS:LMCAD represents a heterogeneous condition and management should be guided by key clinical and anatomic factors. In recent years, there has been a wealth of published prospective data including results of the EXCEL and NOBLE trials. Coronary artery bypass graft (CABG), remains the gold standard for optimal long-term outcomes and the greatest benefit seen in patients with higher anatomic complexity and longer life expectancy. Percutaneous coronary intervention (PCI) offers a less-invasive approach with rapid recovery. PCI is optimal in situations when surgery cannot be offered in a timely manner due to hemodynamic instability, for high-risk surgical patients, or those with limited life expectancy, if LMCAD is anatomically simple. As a result of continued technological and procedural improvements in both PCI and CABG, cardiovascular specialists possess a growing armamentarium of approaches to treat LMCAD. Thus, center specialization and use of a heart team approach are increasingly vital, though barriers remain. SUMMARY:Emerging evidence continues to support CABG as the gold standard for achieving optimal long-term outcomes in patients with LMCAD. PCI offers a more expeditious approach with rapid recovery and is a safe and effective alternative in appropriately selected candidates.
10.1097/HCO.0000000000000777
Use of mechanical circulatory support in high-risk percutaneous coronary interventions.
Progress in cardiovascular diseases
As the field of percutaneous coronary intervention grows in volume, expertise, and available tools, interventional cardiologists are increasingly performing more complex and higher-risk coronary artery procedures. Mechanical circulatory support devices, previously used only in urgent situations, are now being utilized as supplementary tools to enhance outcomes in elective complex cases. This shift has sparked significant discussions about patient and device selection, as well as the potential risks involved. In this article, we explore the various devices and their distinct features. Additionally, we also introduce algorithms for device selection, placement and weaning to help guide physicians during their care for their high-risk PCI patients.
10.1016/j.pcad.2024.10.007
Short- and Mid-Term Outcomes of Complex and High-Risk Versus Standard Percutaneous Coronary Interventions in Patients Undergoing Transcatheter Aortic Valve Replacement.
The Journal of invasive cardiology
BACKGROUND:The prevalence of coronary artery disease (CAD) in patients undergoing TAVR varies and is associated with increased morbidity and mortality. We evaluated the outcomes of complex and high-risk percutaneous coronary interventions (CHIP-PCIs) and TAVR compared with standard PCI and TAVR. Between January 2014 and March 2021, a total of 276 consecutive patients with severe aortic stenosis (AS) who underwent TAVR and PCI at 3 centers within Northwell Health were retrospectively reviewed. CHIP-PCI was defined as PCI with one of the following: left ventricular ejection fraction (LVEF) <30%; left main coronary artery (LMCA)/chronic total occlusion (CTO) intervention; atherectomy; or need for left ventricular (LV) support. One hundred twenty- seven patients (46%) had CHIP-PCI prior to TAVR and 149 patients (54%) had standard PCI. Thirteen percent of CHIP-PCI and 22% of standard PCI cases were done concomitantly with TAVR. CHIP-PCI criteria were met for low EF (19%), LMCA (25%), CTO (3%), LV support (20%), and atherectomy (50%). The types of valves used were similarly divided (49% balloon expandable vs 51% self expanding. Major adverse cardiac or cerebrovascular event (MACCE) rate for CHIP-PCI/TAVR was 4.9% at 30 days vs 1.3% for standard PCI/TAVR (P=.09), driven by in-hospital stroke. At 1 year, the rates of MACCE for CHIP-PCI/TAVR remained higher than for standard PCI/TAVR, but was not statistically significant (8.7% vs 4%; P=.06), driven by revascularization. We found no differences between major and/or minor vascular complications. New York Heart Association classification at 1 month was similar (I/II 93% vs 95%; P=.87). Our study suggests that CHIP-PCI can be safely performed in patients with complex CAD and concomitant severe AS.
10.25270/jic/22.00254
Coronary Physiology Guidance vs Conventional Angiography for Optimization of Percutaneous Coronary Intervention: The AQVA-II Trial.
JACC. Cardiovascular interventions
BACKGROUND:The debate surrounding the efficacy of coronary physiological guidance compared with conventional angiography in achieving optimal post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) values persists. OBJECTIVES:The primary aim of this study was to demonstrate the superiority of physiology-guided PCI, using either angiography or microcatheter-derived FFR, over conventional angiography-based PCI in complex high-risk indicated procedures (CHIPs). The secondary aim was to establish the noninferiority of angiography-derived FFR guidance compared with microcatheter-derived FFR guidance. METHODS:Patients with obstructive coronary lesions and meeting CHIP criteria were randomized 2:1 to receive undergo physiology- or angiography-based PCI. Those assigned to the former were randomly allocated to angiography- or microcatheter-derived FFR guidance. CHIP criteria were long lesion (>28 mm), tandem lesions, severe calcifications, severe tortuosity, true bifurcation, in-stent restenosis, and left main stem disease. The primary outcome was invasive post-PCI FFR value. The optimal post-PCI FFR value was defined as >0.86. RESULTS:A total of 305 patients (331 study vessels) were enrolled in the study (101 undergoing conventional angiography-based PCI and 204 physiology-based PCI). Optimal post-PCI FFR values were more frequent in the physiology-based PCI group compared with the conventional angiography-based PCI group (77% vs 54%; absolute difference 23%, relative difference 30%; P < 0.0001). The occurrence of the primary outcome did not differ between the 2 physiology-based PCI subgroups, demonstrating the noninferiority of angiography- vs microcatheter-derived FFR (P < 0.01). CONCLUSIONS:In CHIP patients, procedural planning and guidance on the basis of physiology (through either angiography- or microcatheter-derived FFR) are superior to conventional angiography for achieving optimal post-PCI FFR values. (Physiology Optimized Versus Angio-Guided PCI [AQVA-II]; NCT05658952).
10.1016/j.jcin.2023.10.032
OCT-Guided vs Angiography-Guided Coronary Stent Implantation in Complex Lesions: An ILUMIEN IV Substudy.
Journal of the American College of Cardiology
BACKGROUND:ILUMIEN IV was the first large-scale, multicenter, randomized trial comparing optical coherence tomography (OCT)-guided vs angiography-guided stent implantation in patients with high-risk clinical characteristics and/or complex angiographic lesions. OBJECTIVES:The authors aimed to specifically examine outcomes in the complex angiographic lesions subgroup. METHODS:From the original trial population (N = 2,487), high-risk patients without complex angiographic lesions were excluded (n = 514). Complex angiographic lesion characteristics included: 1) long or multiple lesions with intended total stent length ≥28 mm; 2) bifurcation lesion with intended 2-stent strategy; 3) severely calcified lesion; 4) chronic total occlusion; or 5) in-stent restenosis. The study endpoints were: 1) final minimal stent area (MSA); 2) 2-year composite of serious major adverse cardiovascular events (MACEs) (cardiac death, target-vessel myocardial infarction [MI], or stent thrombosis); and 3) 2-year effectiveness, defined as target-vessel failure (TVF), a composite of cardiac death, target-vessel MI, or ischemia-driven target-vessel revascularization. RESULTS:The postpercutaneous coronary intervention (PCI) MSA was larger in the OCT-guided (n = 992) vs angiography-guided (n = 981) group (5.56 ± 1.95 mm vs 5.26 ± 1.81 mm; difference, 0.30; 95% CI: 0.14-0.47; P < 0.001). Compared with angiography-guided PCI, OCT-guided PCI resulted in a lower risk of serious MACE (3.1% vs 4.9%; HR: 0.63; 95% CI: 0.40-0.99; P = 0.04). TVF was not significantly different between groups (7.3% vs 8.8%; HR: 0.82; 95% CI: 0.59-1.12; P = 0.20). CONCLUSIONS:In complex angiographic lesions, OCT-guided PCI led to a larger MSA and reduced the serious MACE, the composite of cardiac death, target-vessel MI, or stent thrombosis, compared with angiography-guided PCI at 2 years, but did not significantly improve TVF. (Optical Coherence Tomography Guided Coronary Stent Implantation Compared to Angiography: A Multicenter Randomized Trial in PCI; NCT03507777).
10.1016/j.jacc.2024.04.037
Intravascular imaging-guided vs. angiography-guided percutaneous coronary intervention: A systematic review and meta-analysis of randomized controlled trials in high-risk patients and complex coronary anatomies.
International journal of cardiology
BACKGROUND:Despite a large body of evidence supporting the use of intravascular imaging (IVI) to guide percutaneous coronary intervention (PCI), concerns exist about its universal recommendation. The selective use of IVI to guide PCI of complex lesions and patients is perceived as a rational approach. METHODS:We performed a systematic review and meta-analysis of randomized controlled trials (RCTs). Embase, PubMed, and Cochrane were systematically searched for RCTs that compared IVI-guided PCI with angiography-guided PCI in high-risk patients and complex coronary anatomies. The primary outcome was major adverse cardiac events (MACE). A random-effects model was used to calculate the risk ratios (RRs) with 95 % confidence intervals (CIs). RESULTS:A total of 15 RCTs with 14,109 patients were included and followed for a weighted mean duration of 15.8 months. IVI-guided PCI was associated with a decrease in the risk of MACE (RR: 0.65; 95 % CI: 0.56-0.77; p < 0.01), target vessel failure (TVF) (RR: 0.66; 95 % CI: 0.52-0.84; p < 0.01), all-cause mortality (RR: 0.71; 95 % CI: 0.55-0.91; p < 0.01), cardiovascular mortality (RR: 0.47; 95 % CI: 0.34-0.65; p < 0.01), stent thrombosis (RR: 0.55; 95 % CI: 0.38-0.79; p < 0.01), myocardial infarction (RR: 0.81; 95 % CI: 0.67-0.98; p = 0.03), and repeated revascularizations (RR: 0.70; 95 % CI: 0.58-0.85; p < 0.01) compared with angiography. There was no significant difference in procedure-related complications (RR: 1.03; 95 % CI: 0.75-1.42; p = 0.84) between groups. CONCLUSIONS:Compared with angiographic guidance alone, IVI-guided PCI of complex lesions and high-risk patients significantly reduced all-cause and cardiovascular mortality, MACE, TVF, stent thrombosis, myocardial infarction, and repeat revascularization.
10.1016/j.ijcard.2024.132510
When the Complex Meets the High-Risk: Mechanical Cardiac Support Devices and Percutaneous Coronary Interventions in Severe Coronary Artery Disease.
Ly Hung Q,Noly Pierre-Emmanuel,Nosair Mohamed,Lamarche Yoan
The Canadian journal of cardiology
Coronary artery disease (CAD) remains a leading cause of mortality and morbidity worldwide. Few practice guidelines directly address the issue of revascularization in patients with CAD at higher risk of periprocedural complications. It remains a challenge to appropriately identify the subset of patients with CAD who will require short-term use of mechanical cardiocirculatory support devices (MCSDs) when high-risk (HR) percutaneous coronary intervention (PCI) is required. Issues of the complexity (coronary anatomy and high burden of comorbidities) and risk status (hemodynamic precarity or compromise) need to be considered when considering revascularization in patients. This review will focus on the evolving concept of protected PCI in patients with CAD, and how a balanced, integrated heart-team approach remains the path to optimal patient-centred care in the setting of HR-PCI supported with MCSD.
10.1016/j.cjca.2019.12.001
Revascularization for Coronary Artery Disease: Principle and Challenges.
Gu Dachuan,Qu Jianyu,Zhang Heng,Zheng Zhe
Advances in experimental medicine and biology
Coronary revascularization is the most important strategy for coronary artery disease. This review summarizes the current most prevalent approaches for coronary revascularization and discusses the evidence on the mechanisms, indications, techniques, and outcomes of these approaches. Targeting coronary thrombus, fibrinolysis is indicated for patients with diagnosed myocardial infarction and without high risk of severe hemorrhage. The development of fibrinolytic agents has improved the outcomes of ST-elevation myocardial infarction. Percutaneous coronary intervention has become the most frequently performed procedure for coronary artery disease. The evolution of stents plays an important role in the result of the procedure. Coronary artery bypass grafting is the most effective revascularization approach for stenotic coronary arteries. The choice of conduits and surgical techniques are important determinants of patient outcomes. Multidisciplinary decision-making should analyze current evidence, considering the clinical condition of patients, and determine the safety and necessity for coronary revascularization with either PCI or CABG. For coronary artery disease with more complex lesions like left main disease and multivessel disease, CABG results in more complete revascularization than PCI. Furthermore, comorbidities, such as heart failure and diabetes, are always correlated with adverse clinical events, and a routine invasive strategy should be recommended. For patients under revascularization, secondary prevention therapies are also of important value for the prevention of subsequent adverse events.
10.1007/978-981-15-2517-9_3
Temporal modulation (early escalation and late de-escalation) of antiplatelet therapy in patients undergoing complex high-risk PCI: rationale and design of the TAILORED-CHIP trial.
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Despite the use of conventional dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI), the risk of adverse events remains high among patients with increased thrombotic risk. Until recently, the optimal antiplatelet strategy to balance the ischaemic and bleeding risks in patients who are undergoing complex high-risk PCI has been unclear. The TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI (TAILORED-CHIP) trial is an investigator-initiated, multicentre, prospective randomised trial to evaluate the efficacy and safety of a time-dependent tailored antiplatelet therapy with an early (<6 months post-PCI) escalation (low-dose ticagrelor at 60 mg twice daily plus aspirin) and a late (>6 months post-PCI) de-escalation (clopidogrel monotherapy) in patients undergoing complex high-risk PCI as compared with standard DAPT (clopidogrel plus aspirin for 12 months). Eligible patients had to have at least one high-risk anatomical or procedural feature or clinical characteristic associated with an increased risk of ischaemic or thrombotic events. The primary endpoint was the net clinical outcome, a composite of death from any cause, myocardial infarction, stroke, stent thrombosis, urgent revascularisation, or clinically relevant bleeding (Bleeding Academic Research Consortium type 2, 3, or 5) at 12 months after randomisation. (ClinicalTrials.gov: NCT03465644).
10.4244/EIJ-D-24-00437
Application of Drug-Coated Balloons in Complex High Risk and Indicated Percutaneous Coronary Interventions.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
There is a growing trend of patients with significant comorbidities among those referred for percutaneous coronary intervention (PCI). Consequently, the number of patients undergoing complex high risk indicated PCI (CHIP) is rising. CHIP patients frequently present with factors predisposing to extensive drug-eluting stent (DES) implantation, such as bifurcation and/or heavily calcified coronary lesions, which exposes them to the risks associated with an increased stent burden. The drug-coated balloon (DCB) may overcome some of the limitations of DES, either through a hybrid strategy (DCB and DES combined) or as a leave-nothing-behind strategy (DCB-only). As such, there is a growing interest in extending the application of DCB to the CHIP population. The present review provides an outline of the available evidence on DCB use in CHIP patients, which comprise the elderly, comorbid, and patients with complex coronary anatomy. Although the majority of available data are observational, most studies support a lower threshold for the use of DCBs, particularly when multiple CHIP factors coexist within a single patient. In patients with comorbidities which predispose to bleeding events (such as increasing age, diabetes mellitus, and hemodialysis) DCBs may encourage shorter dual antiplatelet therapy duration-although randomized trials are currently lacking. Further, DCBs may simplify PCI in bifurcation lesions and chronic total coronary occlusions by reducing total stent length, and allow for late lumen enlargement when used in a hybrid fashion. In conclusion, DCBs pose a viable therapeutic option in CHIP patients, either as a complement to DES or as stand-alone therapy in selected cases.
10.1002/ccd.31316
Complex high-risk percutaneous coronary intervention types, trends, and outcomes according to vascular access site.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
BACKGROUND:Radial access is associated with improved outcomes following percutaneous coronary intervention (PCI); however, its role in complex, high-risk percutaneous coronary intervention (CHiP) remains poorly studied. METHODS:We studied retrospectively all registered patients's records from the British Cardiovascular Intervention Society dataset and compared the baseline characteristics, trends and outcomes of CHiP procedures performed electively between January 2006 and December 2017 according to the access site. RESULTS:Out of 137,785 CHiP procedures, 61,825 (44.9%) were undertaken via transradial access (TRA). TRA use increased over time (14.6% in 2006 to 67% in 2017). The TRA patients were older, with a greater prevalence of previous stroke, hypertension, peripheral vascular disease, and smokers. TRA was used more frequently in most CHiP procedures (elderly (51.6%), chronic renal failure (52.6%), poor left ventricular (LV) function (47.6%), left main PCI (48.0%), treatment for severe vascular calcification (50.3%); although transfemoral access (TFA) was used more commonly in those with prior history of coronary artery bypass graft surgery, and PCI to a chronic total occlusion and LV support patients. Following adjustment for differences in clinical and procedural characteristics, TFA was independently associated with higher odds for mortality [adjusted odds ratio (aOR): 1.3 (1.1-1.7)], major bleeding [aOR: 2.9 (2.3-3.4)], and MACCE (following propensity score matching) [aOR: 1.2 (1.1-1.4)]. The same was found with multiple accesses: mortality [aOR: 2.1 (1.5-2.8)], major bleeding [aOR: 5.5 (4.3-6.9)], and MACCE [aOR: 1.4 (1.2-1.7)]. CONCLUSION:TRA has become the predominant access site for CHiP procedures and is associated with significantly lower mortality, major bleeding and MACCE odds than TFA.
10.1002/ccd.30846
Percutaneous Coronary Intervention vs Coronary Artery Bypass Graft Surgery for Left Main Disease in Patients With and Without Acute Coronary Syndromes: A Pooled Analysis of 4 Randomized Clinical Trials.
JAMA cardiology
Importance:Patients with left main coronary artery disease presenting with an acute coronary syndrome (ACS) represent a high-risk and understudied subgroup of patients with atherosclerosis. Objective:To assess clinical outcomes after PCI vs CABG in patients with left main disease with vs without ACS. Design, Setting, and Participants:Data were pooled from 4 trials comparing PCI with drug-eluting stents vs CABG in patients with left main disease who were considered equally suitable candidates for either strategy (SYNTAX, PRECOMBAT, NOBLE, and EXCEL). Patients were categorized as presenting with or without ACS. Kaplan-Meier event rates through 5 years and Cox model hazard ratios were generated, and interactions were tested. Patients were enrolled in the individual trials from 2004 through 2015. Individual patient data from the trials were pooled and reconciled from 2020 to 2021, and the analyses pertaining to the ACS subgroup were performed from March 2022 through February 2023. Main Outcomes and Measures:The primary outcome was death through 5 years. Secondary outcomes included cardiovascular death, spontaneous myocardial infarction (MI), procedural MI, stroke, and repeat revascularization. Results:Among 4394 patients (median [IQR] age, 66 [59-73] years; 3371 [76.7%] male and 1022 [23.3%] female) randomized to receive PCI or CABG, 1466 (33%) had ACS. Patients with ACS were more likely to have diabetes, prior MI, left ventricular ejection fraction less than 50%, and higher SYNTAX scores. At 30 days, patients with ACS had higher all-cause death (hazard ratio [HR], 3.40; 95% CI, 1.81-6.37; P < .001) and cardiovascular death (HR, 3.21; 95% CI, 1.69-6.08; P < .001) compared with those without ACS. Patients with ACS also had higher rates of spontaneous MI (HR, 1.70; 95% CI, 1.25-2.31; P < .001) through 5 years. The rates of all-cause mortality through 5 years with PCI vs CABG were 10.9% vs 11.5% (HR, 0.93; 95% CI, 0.68-1.27) in patients with ACS and 11.3% vs 9.6% (HR, 1.19; 95% CI, 0.95-1.50) in patients without ACS (P = .22 for interaction). The risk of early stroke was lower with PCI vs CABG (ACS: HR, 0.39; 95% CI, 0.12-1.25; no ACS: HR, 0.35; 95% CI, 0.16-0.75), whereas the 5-year risks of spontaneous MI and repeat revascularization were higher with PCI vs CABG (spontaneous MI: ACS: HR, 1.74; 95% CI, 1.09-2.77; no ACS: HR, 3.03; 95% CI, 1.94-4.72; repeat revascularization: ACS: HR, 1.57; 95% CI, 1.19-2.09; no ACS: HR, 1.90; 95% CI, 1.54-2.33), regardless of ACS status. Conclusion and Relevance:Among largely stable patients undergoing left main revascularization and with predominantly low to intermediate coronary anatomical complexity, those with ACS had higher rates of early death. Nonetheless, rates of all-cause mortality through 5 years were similar with PCI vs CABG in this high-risk subgroup. The relative advantages and disadvantages of PCI vs CABG in terms of early stroke and long-term spontaneous MI and repeat revascularization were consistent regardless of ACS status. Trial Registration:ClinicalTrials.gov Identifiers: NCT00114972, NCT00422968, NCT01496651, NCT01205776.
10.1001/jamacardio.2023.1177