Ventricular assist devices in patients with chemotherapy-induced cardiomyopathy: new modalities.

INTRODUCTION: Cardiotoxicity is a fatal complication of chemotherapeutic agents in which the implantation of a mechanical circulatory support system (MCS) can be a life-saving modality. The aim of this article is to analyse this available therapeutic option for patients with cardiotoxicity induced by treatment of malignancy in the light of current literature. We analysed our recent experience with MCS implantations in patients who have advanced heart failure associated with chemotherapy-induced cardiotoxicity. Methods In the hospital registries of 386 adult cardiomyopathy patients who were supported with a long-term impantable MCS in our institution between January 2008 and June 2012, were retrospectively evaluated. In 11 of these patients (mean age ?SD years; overall %; female/male (n); 42 +/- 14, 2.8%, 4/7) MCS was implemented due to chemotherapeutic drug-induced cardiomyopathy (CDIC). Pre-operative and post-operative data of CDIC patients were analysed. RESULTS: In this cohort of CDIC patients, mean duration of circulatory support was 413 ?445 days. One of the patients was successfully bridged to heart transplantation (HTx) after exclusion of possible contraindications. In one patient, left ventricular assist device (LVAD) was successfully explanted after myocardial recovery. In the late post-operative period, five patients expired due to multi-organ failure and gastrointestinal haemorrhage. The remaining 4 patients are still under follow-up on LVAD-support. One of these patients was listed for high-urgency HTx because of device-related infection. CONCLUSION: Cardiotoxicity leading to advanced heart failure is a serious complication of chemotherapeutic agents with a high risk of mortality. In our series LVAD therapy seems to be a beneficial and safe option. LVAD therapy is an acceptable option in chemotherapy-induced, advanced cardiomyopathy.

The Thoratec system implanted as a modified total artificial heart: the Bad Oeynhausen technique.

The CardioWest™ total artificial heart (SynCardia Systems, Tuscon, AZ, USA) is the only FDA-approved total artificial heart determined as a bridge to human heart transplantation for patients dying of biventricular heart failure. Implantation provides immediate hemodynamic restoration and clinical stabilization, leading to end-organ recovery and thus eventually allowing cardiac transplantation. Occasionally, implantation of a total artificial heart is not feasible for anatomical reasons. For this patient group, we have developed an alternative technique using the paracorporeal Thoratec biventricular support system (Thoratec, Pleasanton, CA, USA) as a modified total artificial heart. A detailed description of the implantation technique is presented.

Comparing short-term outcome after implantation of the HeartWare® HVAD® and the Abbott® HeartMate 3®.

AIMS: Centrifugal continuous flow pumps are currently the state of the art in left ventricular assist device therapy. This study was conducted to compare the results after implantation of the HVAD® and the HeartMate 3®. METHODS AND RESULTS: We retrospectively analysed preoperative and post-operative patient data of all 106 patients, who received a HeartMate 3 (HM3) at our centre between 2014 and 2018. A total of 392 patients receiving a sintered HVAD® served as controls. Patient matching was performed for age, sex, Interagency Registry for Mechanically Assisted Circulatory Support level at the time of implant, perioperative right heart failure, and implantation strategy, that is, bridge to transplant or destination therapy, as well as preoperative renal function, that is, as indicated by serum creatinine levels. A total of 79 matched pairs could be identified. During a median follow-up of 15.3 months (range: 0-30 months), 23 (29.1%) and 19 (24.1%) patients died in the HVAD and HM3 groups, respectively, with a hazard ratio for mortality of 0.84 [95% confidence interval (CI): 0.46-1.54; P = 0.568]. Freedom from cerebrovascular events did not differ significantly between study groups, with a hazard ratio of 0.57 (95% CI: 0.23-1.45; P = 0.241). The risk of driveline infection was significantly lower in the HM3 (n = 33) than in the HVAD (n = 55) group (hazard ratio = 0.54; 95% CI: 0.35-0.84; P = 0.006). Eight HVAD, but no HM3, patients developed a pump thrombosis during follow-up (P = 0.148). CONCLUSIONS: Performance of both currently used centrifugal left ventricular assist device systems is comparable in terms of short-term patient survival and freedom from cerebrovascular events. In our single-centre experience, HM3 patients less frequently develop driveline infections and no pump thrombosis, which requires further evaluation.

Current perspectives on mechanical circulatory support.

Mechanical circulatory support gained a significant value in the armamentarium of heart failure therapy because of the increased awareness of the prevalence of heart failure and the tremendous advances in the field of mechanical circulatory support during the last decades. Current device technologies already complement a heart transplant as the gold standard of treatment for patients with end-stage heart failure refractory to conservative medical therapy. This article reviews important aspects of mechanical circulatory support therapy and focuses on currently debated issues.

Management of end-stage heart failure patients with or without ventricular assist device: an observational comparison of clinical and economic outcomes.

OBJECTIVES: Heart transplantation (HT) and ventricular assist devices (VAD) for the management of end-stage heart failure have not been directly compared. We compare the outcomes and use of resources with these 2 strategies in 2 European countries with different allocation systems. METHODS: We studied 83 patients managed by VAD as the first option in Bad Oeynhausen, Germany (Group I) and 141 managed with either HT or medical therapy, as the first option, in Paris, France (Group II). The primary end-point was 2-year survival. Kaplan-Meier analyses were performed after the application of propensity score weights to mitigate the effects of non-random group assignment. The secondary end-points were resource utilization and costs. Subgroup analyses were performed for patients undergoing HT and patients treated with inotropes at the enrolment time. RESULTS: The Group I patients were more severely ill and haemodynamically compromised, and 28% subsequently underwent HT vs 55% primary HT in Group II, P < 0.001. The adjusted probability of survival was 44% in Group I vs 70% in Group II, P <0.0001. The mean cumulated 2-year costs were €281 361 ± 156 223 in Group I and €47 638 ± 35 061 in Group II, P < 0.0001. Among patients who underwent HT, the adjusted probability of survival in Group I (n = 23) versus Group II (n = 78) was 76% versus 68%, respectively (0.09), though it differed in the inotrope-treated subgroups (77% in Group I vs 67% in Group II, P = 0.04). CONCLUSIONS: HT should remain the first option for end-stage heart failure patients, associated with improved outcomes and better cost-effectiveness profile. VAD devices represent an option when transplant is not possible or when patient presentation is not optimal.

Bivalirudin anticoagulation for left ventricular assist device implantation on an extracorporeal life support system in patients with heparin-induced thrombocytopenia antibodies.

OBJECTIVES: Heparin-induced thrombocytopenia (HIT) requires alternative anticoagulation strategies. We investigated outcomes in patients with HIT antibodies undergoing low-dose bivalirudin anticoagulation during left ventricular assist device implantation on an extracorporeal life support system (ECLS) and compared the results with non-HIT patients treated with heparin and receiving left ventricular assist device implantation with ECLS support. METHODS: The institutional ventricular assist device database was searched for the period from March 2012 to March 2016. The primary end-point was the need for early (<7 days) surgical re-exploration due to persistent haemorrhage or cardiac tamponade postoperatively. The secondary clinical end-points were delayed chest closure, stroke, intracranial bleeding, re-thoracotomy >7 days and mortality up to 1 year. Unadjusted comparison was used for the entire groups. Because of non-random group assignment, propensity score matching was also performed to compare treatment effects. RESULTS: Twenty-one patients were treated with bivalirudin and 36 patients with heparin. INTERMACS levels were lower, inotropic score was higher and the prevalence of mechanical ventilation and preoperative ECLS implants was also significantly higher in the heparin group than in the bivalirudin group (P-values <0.05). The primary end-point was reached by 19% in the bivalirudin group and 16.7% in the heparin group (bivalirudin group: odds ratio 1.18, 95% confidence interval 0.29-4.76; P = 0.820). The propensity score-matched groups also showed no difference in this regard (P = 0.455). All secondary clinical end-points were comparable between groups, both in the unadjusted analysis and in the propensity score-matched groups. CONCLUSIONS: In patients with HIT antibodies, low-dose bivalirudin anticoagulation on ECLS support appears to be a feasible option for left ventricular assist device implantation.

Systemic Thrombolysis Versus Device Exchange for Pump Thrombosis Management: A Single-Center Experience.

In patients with left ventricular assist device (LVAD) implants, pump thrombosis is a potential life-threatening complication. In a retrospective data analysis, we compared clinical outcomes in 50 patients with HeartWare (HW) or HeartMate II implants undergoing device exchange (DEx; n = 21) or systemic thrombolysis (STL; n = 29) for pump thrombosis. Primary end-point was survival up to 90 days postintervention. Secondary end-points were the need for blood products postintervention, duration of intensive care unit stay, in-hospital stay, 90 day and 2 year therapy failure (the need for additional surgical or nonsurgical intervention because of pump thrombosis), and 2 year survival. Ninety-day survival was 89.3% in the STL group and 91.0% in the DEx group (p = 0.901). Compared with the DEx group, the average use of different blood products was lower (p < 0.001), and duration of intensive care unit stay and in-hospital stay tended to be shorter in the STL group (p values = 0.086 and 0.048, respectively). However, 90 day freedom from therapy failure was significantly lower in the STL group than in the DEx exchange group (p = 0.027) and so was 2 year freedom from therapy failure (p = 0.006). Two-year survival was comparable between groups (p = 0.267). Our data indicate that STL can be considered as a therapeutic option in LVAD patients with pump thrombosis.

Mechanical circulatory support devices as destination therapy-current evidence.

Advanced heart failure is an increasing problem worldwide. Nowadays, mechanical circulatory support devices (MSCD) are an established therapeutic option for terminal heart failure after exhaustion of medical and conventional surgical treatment, and are becoming a realistic alternative to heart transplantation (HTX). There are a number of different treatment options for these patients, such as bridge to transplantation (BTT), bridge to candidacy (BTC), bridge to recovery (BTR) and the destination therapy (DT) option. The latter option has become more frequent throughout the last years, due to a donor organ shortage and an increasing number of older patients with terminal heart failure who are not eligible for HTX. These factors have led to a rapidly increasing number of LVAD implantations as well as centers which perform these procedures. This has also been due to improved LVAD survival rates and quality of life following the introduction of smaller, intrapericardial and more durable continuous flow left ventricular devices. The most common complications for these patients are device-related problems, such as coagulation disorders, gastrointestinal bleeding, device related infection, pump thrombosis or cerebrovascular accidents. However, some questions still remain unanswered or under debate, such as the exact time-point for LVAD implantation. In addition, aspects such as better biocompatibility for LVADs remain a major challenge. This review will concentrate on DT for terminal heart failure and provide an overview of the current evidence for LVAD implantation in this patient group, with particular emphasis on indication and time-point of implantation, choice of LVADs, and long term outcomes and quality of life.

Temporary right ventricular mechanical circulatory support for the management of right ventricular failure in critically ill patients.

BACKGROUND: Management of right ventricular (RV) failure after left ventricular assist device (LVAD) implantation is not evidence based. Temporary circulatory assistance has recently been reported to be of value for managing postoperative RV failure after LVAD implantation, but only in small series of patients or isolated case reports. We report here our experience with the use of temporary right ventricular assist devices (RVADs) in LVAD recipients. METHODS: Forty-five of the 488 (9%) patients undergoing LVAD implantation between 2001 and 2011 at the Clinic for Thoracic and Cardiovascular Surgery in Bad Oeynhausen had RV failure requiring temporary RVAD. We analyzed preoperative data, complications, mortality at 6 months, and risk factors of death. RESULTS: The LVAD patients receiving temporary RVAD were younger than the 443 recipients of LVAD alone. They were more likely to have mechanical ventilation and haemofiltration and their Michigan right ventricular risk score was higher. The LVAD patients with temporary RVAD had a higher mortality at 6 months: 53%, versus 25% for patients receiving LVAD only (P < .001). The univariate risk factors for death were high blood urea nitrogen and C-reactive protein concentrations, preoperative mechanical ventilation, preoperative hemofiltration, destination therapy, the use of temporary RVAD, and the development of RV failure. Multivariate analyses did not identify predictors of death. CONCLUSIONS: The development of RV failure in LVAD recipients is a serious problem associated with high mortality. Temporary RV mechanical support is an acceptable way to manage postoperative RV failure in these severely ill LVAD recipients.

DuraHeart magnetically levitated centrifugal left ventricular assist system for advanced heart failure patients.

The implantable left ventricular assist system (LVAS) using pulsatile pump technology has become an established therapeutic option for advanced heart failure patients. However, there have been technological limitations in some older designs, including a high incidence of infection and mechanical failures associated with moving parts, and the large size of both implantable pump and percutaneous cable. A smaller rotary blood pump emerged as a possible alternative to a large pulsatile pump to overcome some of these limitations. The technological advancement that defines the third-generation LVAS was the elimination of all mechanical contacts between the impeller and the drive mechanism. The DuraHeart LVAS is the world's first third-generation implantable LVAS to obtain market approval (CE-mark), which combines a centrifugal pump and active magnetic levitation. The initial clinical experience with the DuraHeart LVAS in Europe demonstrated that it provided significantly improved survival (85% at 6 months and 79% at 1 year), reduced adverse event rates and long-term device reliability (freedom from device replacement at 2 years: 96 +/- 3%) over pulsatile LVAS.