Survival Results After Implantation of Intrapericardial Third‐Generation Centrifugal Assist Device: An INTERMACS‐Matched Comparison Analysis

Abstract

Reports on third-generation centrifugal intrapericardial pumps (HeartWare International, Inc., Framingham, MA, USA) have shown better survival results than the previous-generation devices. However, outcomes depending on the preoperative level of stability can substantially differ, resulting in a limited analysis of potentialities and drawbacks of a given device. In the present study we sought to compare in our single-center experience the survival results of this third-generation device with previous left ventricular systems taking into account the different preoperative Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) levels. Between February 1993 and March 2012, 287 patients underwent assist device implantation in our university hospital (INTERMACS Level 1-2 = 158 patients; INTERMACS Level 3-4-5 = 129 patients). Assist devices implanted were: Group A (HVAD HeartWare, n = 52), group B (previous continuous-flow ventricular assist device [VAD], InCor [Berlin Heart, Berlin, Germany], n = 37; VentrAssist [VentraCor, Inc., Chatswood, NSW, Australia], n = 7; DeBakey [MicroMed Cardiovascular, Inc., Houston, TX, USA], n = 32), and group C (pulsatile systems, n = 159). After cumulative support duration of 54 436 days and a mean follow-up of 6.21 ± 7.46 months (range 0-45.21 months), log-rank analysis revealed a survival for group A of 82.0%, 70.4%, and 70.4%; for group B of 84.0%, 48.2%, 33.7%; and for group C of 71.6%, 46.1%, 33.8%, at 1, 12, and 24 months respectively, with a significantly (P = 0.013) better outcome for group A. When stratifying the survival on the basis of INTERMACS level, no significant survival improvement was observed among all patients who underwent VAD implantation in INTERMACS 1-2 (P = 0.47). However, among patients who underwent elective VAD implantation (INTERMACS 3-4-5), group A had a significantly better outcome (P = 0.005) compared with the other INTERMACS-matched groups (B,C) with a survival rate of 88.8% in group A versus 34.2% in group B and 45.6% in group C at 24 months, respectively. Elective HVAD system implantation shows improved survival benefit over the other INTERMACS-matched devices. Moreover, preoperative unstable hemodynamics resulted in a poor prognosis independently from the pump generation.

Contributory Role of Fluorine 18-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in the Diagnosis and Clinical Management of Infections in Patients Supported With a Continuous-Flow Left Ventricular Assist Device

“…(Ann Thorac Surg 2015;-:---) Ó 2015 by The Society of Thoracic Surgeons N owadays, new-generation left ventricular assist devices (VADs), in conjunction with more appropriate indications, offer the possibility to support patients for a notably long time [1,2]. In this context, besides concerns regarding the early postoperative period, long-term survival and the freedom from major complications, such as infections, are gaining increasing importance.…”

Left ventricular assist device: a bridge to transplant or destination therapy?

“…Nevertheless, post-transplant survival rates appear higher in patients with CF-LVAD implants compared with PF devices, especially for the newer third generation HVAD. The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) has allowed comparative analyses between the device generations, results of which demonstrate significantly improved survival rates of the HVAD compared with previous INTERMACS-matched CF and PF models (p=0.013) 25. INTERMACS data collection and analysis is overseen by the National Heart, Lung and Blood Institute, the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services, working in conjunction with the University of Alabama.…”

“…However, importantly, the quality of life and functional capacity improvements were much larger than those seen with any other device therapy for advanced heart failure, and were similar to those obtained with cardiac transplantation. Overall, HeartWare (HVAD) provides promising improvements in survival rates and reduced adverse events 25 26…”

Artificial Organs 2014: A Year in Review

“…Angelo M. Dell'Aquila et al. of the University of Muenster, Muenster, Germany, reported on this center's survival results after implantation of intrapericardial third‐generation centrifugal assist devices compared with previous left ventricular systems (VAD), taking into account the different preoperative INTERMACS levels. No significant survival improvement was observed among all patients who underwent VAD implantation in INTERMACS Levels 1–2.…”