A prospective comparison of mid-term outcomes in patients treated with heart transplantation with advanced age donors versus left ventricular assist device implantation

ORIGINAL ARTICLE – ADULT CARDIAC Interactive CardioVascular and Thoracic Surgery 23 (2016) 584–592 doi:10.1093/icvts/ivw164 Advance Access publication 30 May 2016 Cite this article as: Ammirati E, Cipriani MG, Varrenti M, Colombo T, Garascia A, Cannata A et al. A prospective comparison of mid-term outcomes in patients treated with heart transplantation with advanced age donors versus left ventricular assist device implantation. Interact CardioVasc Thorac Surg 2016;23:584–92. A prospective comparison of mid-term outcomes in patients treated with heart transplantation with advanced age donors versus left ventricular assist device implantation Enrico Ammiratia,†*, Manlio G. Cipriania,†, Marisa Varrentia, Tiziano Colomboa, Andrea Garasciaa, Aldo Cannataa, Giovanna Pedrazzinia, Elena Benazzib, Filippo Milazzoa, Fabrizio Olivaa, Maria P. Gagliardonea, Claudio F. Russoa and Maria Frigerioa a b ‘De Gasperis’ Cardio Center, Niguarda Ca’ Granda Hospital, Milan, Italy Coordinamento trapianti North Italy Transplantation program (NITp), Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy * Corresponding author. ‘De Gasperis’ Cardio Center and Transplant Center, Niguarda Ca’ Granda Hospital, Piazza Ospedale Maggiore 3, 20162 Milan, Italy. Tel: +39-02644-7791; e-mail: (E. Ammirati). Received 9 December 2015; received in revised form 20 April 2016; accepted 26 April 2016 Abstract OBJECTIVES: In Europe, the age of heart donors is constantly increasing. Ageing of heart donors limits the probability of success of heart transplantation (HTx). The aim of this study is to compare the outcome of patients with advanced heart failure (HF) treated with a continuous-flow left ventricular assist device (CF-LVAD) with indication as bridge to transplantation (BTT) or bridge to candidacy (BTC) versus recipients of HTx with the donor’s age above 55 years (HTx with donors >55 years). METHODS: we prospectively evaluated 301 consecutive patients with advanced HF treated with a CF-LVAD (n = 83) or HTx without prior bridging (n = 218) in our hospital from January 2006 to January 2015. We compared the outcome of CF-LVAD-BTT (n = 37) versus HTx with donors >55 years (n = 45) and the outcome of CF-LVAD-BTT plus BTC (n = 62) versus HTx with donors >55 years at the 1- and 2-year follow-up. Survival was evaluated according to the first operation. RESULTS: The perioperative (30-day) mortality rate was 0% in the LVAD-BTT group vs 20% (n = 9) in the HTx group with donors >55 years (P = 0.003). Perioperative mortality occurred in 5% of the LVAD-BTT/BTC patients (n = 3) and in 20% of the HTx with donors >55 year group (P = 0.026). Kaplan–Meier curves estimated a 2-year survival rate of 94.6% in CF-LVAD-BTT vs 68.9% in HTx with donors >55 years [ageand sex-adjusted hazard ratio (HR) 0.25; 95% confidence interval (CI) 0.08–0.81; P = 0.02 in favour of CF-LVAD]. Considering the post-HTx outcome, a trend in favour of CF-LVAD-BTT was also observed (age- and sex-adjusted HR 0.45; 95% CI 0.17–1.16; P = 0.09 in favour of CFLVAD), whereas CF-LVAD-BTT/BTC showed a similar survival at 2 years compared with HTx with donors >55 years, both censoring the follow-up at the time of HTx and considering the post-HTx outcome. CONCLUSIONS: Early and mid-term outcomes of patients treated with a CF-LVAD with BTT indication seem better than HTx with old donors. It must be emphasized that up to 19% of patients in the CF-LVAD/BTT group underwent transplantation in an urgent condition due to complications related to the LVAD. At the 2-year follow-up, CF-LVAD with BTT and BTC indications have similar outcome than HTx using old heart donors. These results must be confirmed in a larger and multicentre population and extending the follow-up. Keywords: Left ventricular assist device • Heart transplantation • Advanced heart failure • Marginal donor • Age INTRODUCTION Heart transplantation (HTx) is still the gold standard for refractory and advanced heart failure (HF) [1, 2]. Continuous-flow left ventricular assist devices (CF-LVADs) are becoming another valuable choice of treatment for patients with advanced HF, either listed for HTx (bridge to transplantation, BTT) or ineligible for HTx † Enrico Ammirati and Manlio G. Cipriani contributed equally to this study. (destination therapy, DT), or with risk factors or temporary contraindications for HTx that can resolve over time on CF-LVAD support (bridge to candidacy-BTC) [3, 4]. Mechanical devices have predictable performances, and different models show similar clinical outcomes (1 year
85%) [5, 6]. On the other hand, donor hearts are different and their characteristics can affect the outcome of transplantation. Age, presence of coronary artery disease and low left ventricular ejection fraction (LVEF <50%) are recognized as donor characteristics associated with unfavourable © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. E. Ammirati et al. / Interactive CardioVascular and Thoracic Surgery METHODS BTT (LVAD-BTT, n = 37), and versus those treated with CF-LVAD as BTT or BTC (LVAD-BTT/BTC, n = 62). Survival was evaluated according to the first operation. Follow-up data were available for all the patients, and were analysed until the end of February 2015, when all the patients have at least a 1-month follow-up. In the survival analysis, patients were censored at 2 years, or at the last visit (when the follow-up was shorter than 2 years), or at the time of death or (for LVAD patients) at the time of HTx. The outcome of HTx in CF-LVAD patients was analysed separately. Continuous-flow left ventricular assist device used Four different CF-LVADs were used. The CF-LVADs as BTT (n = 37) were 2 (5%) Micromed DeBakey LVAD (Micromed Technology, Inc., TX, USA), 2 (5%) Berlin Heart Incor (Berlin Heart AG, Germany), 30 (81%) HeartMate II (HMII, Thoratec, USA) and 3 (8%) HVAD (HeartWare, Australia). The CF-LVAD-BTT/BTC (n = 62) implanted were 5 (8%) Micromed DeBakey LVAD, 5 (8%) Berlin Heart Incor, 42 (68%) HMII and 10 (16%) HVAD. Details on surgical technique, device description, anticoagulation treatment and follow-up of patients under CF-LVAD have been previously described [15]. Statistical analysis The statistical analysis was performed using the SPSS statistical software package v 17.0 (SPSS, Inc., Chicago, IL, USA). Normally distributed data are presented as means ± standard deviation (SD) for continuous variables, whereas skewed data (not passing the Shapiro–Walk normality test) as medians and interquartiles (Q1–Q3). Dichotomous variables are expressed as proportions. Differences in prevalence between groups were compared with Fisher’s exact test for dichotomous variables. Group differences in continuous variables were determined by using Student’s t-test for normally distributed values and the Mann–Whitney U-test for Study population Prospective data collection was independently (...truncated)