Biventricular circulatory support with two miniaturized implantable assist devices.
Krabatsch Thomas,Potapov Evgenij,Stepanenko Alexander,Schweiger Martin,Kukucka Marian,Huebler Michael,Hennig Ewald,Hetzer Roland
Circulation
BACKGROUND:Up to 30% of patients with end-stage heart failure experience biventricular failure that requires biventricular mechanical support. For these patients, only bulky extracorporeal or implantable displacement pumps or the total artificial heart have been available to date, which enables only limited quality of life for the patients. It was our goal to evaluate a method that would allow the use of 2 implantable centrifugal left ventricular assist devices as a biventricular assist system. METHODS AND RESULTS:Seventeen patients have been implanted with 2 HeartWare HVAD pumps, 1 as a left ventricular assist device and 1 as a right ventricular assist device. Seventy-seven percent of the patients had idiopathic dilated or ischemic cardiomyopathy. Their age ranged from 29 to 73 years (mean 51.8 ± 14.5 years), and 11 (64.7%) received intravenous catecholamine support preoperatively. The right ventricular assist device pump was implanted into the right ventricular free wall. The afterload of this pump was artificially increased by local reduction of the outflow graft diameter, and the effective length of its inflow cannula was reduced by the addition of two 5-mm silicon suture rings to the original HVAD implantation ring. All right ventricular assist device devices could be operated in appropriate speed ranges and delivered a flow of between 3.0 and 5.5 L/min. Thirty-day survival was 82%, and 59% of the patients could be discharged home after recovering from the operation. There was no clinically relevant hemolysis in any of the patients. CONCLUSIONS:Two HeartWare HVAD pumps can be used as a biventricular assist system. This implantable biventricular support gives the patients more comfort and mobility than usual biventricular ventricular assist devices with large and noisy displacement pumps.
10.1161/CIRCULATIONAHA.110.011502
Predicting the Risk of Right Ventricular Failure in Patients Undergoing Left Ventricular Assist Device Implantation: A Systematic Review.
Frankfurter Claudia,Molinero Micaela,Vishram-Nielsen Julie K K,Foroutan Farid,Mak Susanna,Rao Vivek,Billia Filio,Orchanian-Cheff Ani,Alba Ana Carolina
Circulation. Heart failure
BACKGROUND:Right ventricular failure (RVF) is a cause of major morbidity and mortality after left ventricular assist device (LVAD) implantation. It is, therefore, integral to identify patients who may benefit from biventricular support early post-LVAD implantation. Our objective was to explore the performance of risk prediction models for RVF in adult patients undergoing LVAD implantation. METHODS:A systematic search was performed on Medline, Embase, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews from inception until August 2019 for all relevant studies. Performance was assessed by discrimination (via C statistic) and calibration if reported. Study quality was assessed using the Prediction Model Risk of Bias Assessment Tool criteria. RESULTS:After reviewing 3878 citations, 25 studies were included, featuring 20 distinctly derived models. Five models were derived from large multicenter cohorts: the European Registry for Patients With Mechanical Circulatory Support, Interagency Registry for Mechanically Assisted Circulatory Support, Kormos, Pittsburgh Bayesian, and Mechanical Circulatory Support Research Network RVF models. Seventeen studies (68%) were conducted in cohorts implanted with continuous-flow LVADs exclusively. The definition of RVF as an outcome was heterogenous among models. Seven derived models (28%) were validated in at least 2 cohorts, reporting limited discrimination (C-statistic range, 0.53-0.65). Calibration was reported in only 3 studies and was variable. CONCLUSIONS:Existing RVF prediction models exhibit heterogeneous derivation and validation methodologies, varying definitions of RVF, and are mostly derived from single centers. Validation studies of these prediction models demonstrate poor-to-modest discrimination. Newer models are derived in cohorts implanted with continuous-flow LVADs exclusively and exhibit modest discrimination. Derivation of enhanced discriminatory models and their validations in multicenter cohorts is needed.
10.1161/CIRCHEARTFAILURE.120.006994
First In Vivo Experience With Biventricular Circulatory Assistance Using a Single Continuous Flow Pump.
Karimov Jamshid H,Horvath David J,Miyamoto Takuma,Kado Yuichiro,Gao Shengqiang,Kuban Barry D,Polakowski Anthony R,Sale Shiva,Fukamachi Kiyotaka
Seminars in thoracic and cardiovascular surgery
Biventricular assist device (BVAD) implantation is the treatment of choice in patients with severe biventricular heart failure and cardiogenic shock. Our team has developed a miniaturized continuous flow, double-ended centrifugal pump intended for total artificial heart implant (CFTAH). The purpose of this initial in vivo study was to demonstrate that the scaled-down CFTAH (P-CFTAH) can be appropriate for BVAD support. The P-CFTAH was implanted in 4 acute lambs (average weight, 41.5 ± 2.8 kg) through a median sternotomy. The cannulation was performed through the left and right atria, and cannulae length adjustment was performed for atrial and ventricular cannulation. The BVAD system was tested at 3 pump speeds (3000, 4500, and 6000 rpm). The BVAD performed very well for both atrial and ventricular cannulation within the 3000-6000 rpm range. Stable hemodynamics were maintained after implantation of the P-CFTAH. The self-regulating performance of the system in vivo was demonstrated by the left (LAP) and right (RAP) pressure difference (LAP-RAP) falling predominantly within the range of -5 to 10 mm Hg with variation, in addition to in vitro assessment of left and right heart failure conditions. Left and right pump flows and total flow increased as the BVAD speed was increased. This initial in vivo testing of the BVAD system demonstrated satisfactory device performance and self-regulation for biventricular heart failure support over a wide range of conditions. The BVAD system keeps the atrial pressure difference within bounds and maintains acceptable cardiac output over a wide range of hemodynamic conditions.
10.1053/j.semtcvs.2020.03.006
Two implantable continuous-flow ventricular assist devices in a biventricular configuration: technique and results.
Eulert-Grehn Jaime-Jürgen,Lanmüller Pia,Schönrath Felix,Solowjowa Natalia,Müller Marcus,Mulzer Johanna,Kaufmann Friedrich,Starck Christoph,Krabatsch Thomas,Falk Volkmar,Potapov Evgenij
Interactive cardiovascular and thoracic surgery
OBJECTIVES:No continuous-flow right ventricular assist device for long-term support is available at the moment. Two continuous-flow ventricular assist devices used in a continuous-flow biventricular assist device configuration is an emerging option which has proven its feasibility but still is not approved for routine use. We present our technique and results of modifying the left ventricular assist device and making it suitable for right ventricular support. METHODS:Between September 2009 and October 2017, 39 patients received implantation of a continuous-flow ventricular assist device for right ventricular support in a continuous-flow biventricular assist device configuration. For implantation of the HeartWare® manufacturers name of the pump HeartWare HVAD pump (HVAD)® centrifugal ventricular assist device, we performed 2 major modifications: banding of the outflow graft and reducing the intracaval length of the inflow cannula. The HVAD® could be safely implanted into the right atrium or ventricle. The HeartMate 3® left ventricular assist device needed no banding, but we increased the extraventricular part of the inflow cannula. RESULTS:The overall 30-day survival for the group receiving primarily a continuous-flow biventricular assist device was 72.7% (9.5% standard error of the mean (SEM)), and the 1-year survival was 45.0% (10.7% SEM). The overall 30-day survival for the group receiving a subsequent pump for right ventricular support in a continuous-flow biventricular assist device configuration after temporary right ventricular support was 71.4% (12.1% SEM), and 1-year survival was 40.8% (13.6% SEM). CONCLUSIONS:At the moment, there is a lack of a continuous-flow right ventricular assist device especially designed and approved for right ventricular support. Therefore, modifications in continuous-flow ventricular assist devices designed for the left ventricle are done to make them suitable for right ventricular support. However, more information is needed regarding the optimal surgical technique, patient selection and the optimal time point of implantation.
10.1093/icvts/ivy228
Are biventricular assist devices underused as a bridge to heart transplantation in patients with a high risk of postimplant right ventricular failure?
Bartfay Sven-Erik,Dellgren Göran,Lidén Hans,Holmberg Mikael,Gäbel Jakob,Redfors Bengt,Bech-Hanssen Odd,Karason Kristjan
The Journal of thoracic and cardiovascular surgery
OBJECTIVE:Right ventricular failure in patients treated using left ventricular assist devices is associated with poor outcomes. We assessed the strategy of preplanned biventricular assist device implantation in patients with a high risk for right ventricular failure. METHODS:Between 2010 and 2014, we assigned 20 patients to preplanned biventricular assist device and 21 patients to left ventricular assist device as a bridge to heart transplantation on the basis of the estimated risk of postimplant right ventricular failure. Preimplant characteristics and postimplant outcomes were compared between the 2 groups. RESULTS:Patients with a biventricular assist device were younger, more often female, and more frequently had nonischemic heart disease than left ventricular assist device recipients. At preoperative assessment, biventricular assist device recipients had poorer Interagency Registry for Mechanically Assisted Circulatory Support profiles, a lower cardiac index, and more compromised right ventricular function. Survival on device to heart transplantation/weaning/destination for biventricular assist device and left ventricular assist device recipients was 90% versus 86% (not significant), with shorter heart transplantation waiting times for biventricular assist device recipients (median days, 154 vs 302, P < .001). Overall survival at 1 year was 85% (95% confidence interval, 62-95) versus 86% (95% confidence interval, 64-95) (not significant). The majority of both biventricular assist device and left ventricular assist device recipients could be discharged to home during the heart transplantation waiting time (55% vs 71%, not significant), and complication rates on device were comparable between groups (major stroke 10% vs 10%, not significant). CONCLUSIONS:Planned in advance, the biventricular assist device seems to be a feasible option as bridge to heart transplantation for patients with a high risk of postimplant right ventricular failure. The outcomes for these patients were similar to those observed for contemporary left ventricular assist device recipients, despite those receiving biventricular assist devices being more severely ill.
10.1016/j.jtcvs.2016.09.084
International experience using a durable, centrifugal-flow ventricular assist device for biventricular support.
Marasco Silvana,Simon André R,Tsui Steven,Schramm René,Eifert Sandra,Hagl Christian M,Paç Mustafa,Kervan Ümit,Fiane Arnt E,Wagner Florian M,Garbade Jens,Özbaran Mustafa,Hayward Christopher S,Zimpfer Daniel,Schmitto Jan D
The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation
BACKGROUND:Heart transplantation is limited by the scarcity of suitable donors. Patients with advanced biventricular failure may require biventricular support to provide optimal cardiac output and end-organ perfusion. We highlight the outcomes of using the HeartWare HVAD System (HVAD) in a biventricular configuration. METHODS:This retrospective study included patients implanted with HVAD as a biventricular assist device (BiVAD) between 2009 and 2017 at 12 participating centers. When used as a right ventricular assist device (VAD) (RVAD), the HVAD can be attached to the right ventricle (RV) or the right atrium (RA). Kaplan-Meier survival estimates were calculated comparing the 2 RVAD implant locations. Comparisons were also made between the timing of RVAD implantation (primary vs staged) on adverse event (AE) profiles and survival. RESULTS:Among the 93 patients who were implanted with a HVAD BiVAD, Kaplan-Meier survivals at 1-year and 2-year were 56% and 47%, respectively. Survival was independent of the location of the HVAD RVAD implant or whether there was an interval between left VAD and RVAD implantation. The most common AEs were bleeding (35.5%), infection (25.8%), and respiratory failure (20.4%). CONCLUSIONS:This study illustrated similar survival in patients receiving a primary or staged HVAD BiVAD implant at 1 year and 2 years. This study also established that the locations of the RVAD implant (RV or RA) result in similar AE profiles.
10.1016/j.healun.2020.08.006