Juliane Vierecke1, Brigitta Gahl2, Theo M M H de By3, Herwig Antretter4, Friedhelm Beyersdorf5,6, Kadir Caliskan7, Valeriya Krachak8, Antonio Loforte9, Evgenij Potapov10, Felix Schoenrath10, Bernard Stockman11, Marc Vanderheyden8, Bart Meyns12, Jan Gummert13, Paul Mohacsi1. 1. Department of Cardiovascular Surgery, University Hospital Bern, University of Bern, Bern, Switzerland. 2. Division of Cardiac Surgery, University Hospital Basel, Basel, Switzerland. 3. EUROMACS, EACTS, Windsor, UK. 4. Universitätsklinik für Herzchirurgie, Medizinische Universität Innsbruck, Innsbruck, Austria. 5. Universitäts-Herzzentrum Freiburg - Bad Krozingen, Bad Krozingen, Germany. 6. Medical Faculty of the Albert-Ludwigs-University Freiburg, Freiburg, Germany. 7. Department of Cardiology, Erasmus MC Rotterdam, Rotterdam, Netherlands. 8. Extracoporeal Department, RSPC Cardiology, Minsk, Belarus. 9. Department of Cardiovascular Surgery, S. Orsola-Malpighi, University Hospital Bologna, Bologna, Italy. 10. Department of Cardiothoracic and Vascular Surgery, German Heart Centre Berlin, Berlin, Germany. 11. Department of Cardiology, Onze-Lieve-Vrouw Ziekenhuis, Aalst, Belgium. 12. Department of Cardiovascular Surgery, UZ Gasthuisberg, Leuven, Belgium. 13. Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Centre NRW, University Hospital of the Ruhr-University of Bochum, Bad Oeynhausen, Germany.
Abstract
OBJECTIVES: The purpose of this study was to describe pre- and postoperative data from the EUROMACS registry with regard to indications, for and survival and complication rates of patients with primary continuous flow and pulsatile biventricular long-term assist devices (BiVADs) versus total artificial hearts (TAHs) or left ventricular assist devices (LVADs) + short-term right ventricular assist device (RVAD) implants. METHODS: We investigated patients who received implants between 1 January 2011 and 21 October 2017. Clinical baseline information about comorbidities, laboratory results, medical and device therapies and echocardiographic, haemodynamic and right ventricle (RV) parameters were evaluated along with the rates of deaths and complications. RESULTS: A total of 413 of 3282 patients (12.5%) needed a biventricular pump. We investigated 37 long-term BiVADs, 342 LVAD + short-term RVAD implants and 34 TAHs. Minor differences were found in the baseline characteristics of our population, which had an overall high morbidity profile. The 1-year survival rate was 55% for patients with a continuous flow BiVAD; 52% for patients with an LVAD + short-term RVAD; 37% for patients with pulsatile BiVADs; and 36% for patients with a TAH. No statistical difference was observed among the groups. Over 50% of patients with BiVAD support were classified as INTERMACS profiles 1 and 2. The percent of patients with ambulatory heart failure (INTERMACS 4‒7) undergoing BiVAD implants was modest at <15%. No patients with a pulsatile BiVAD (n = 15) or a TAH (n = 34) were implanted as destination therapy, but 27% of the patients with continuous flow BiVADs (n = 6) and 23% of the patients with LVAD + short-term RVAD (n = 342) were implanted as 'destination'. The adverse events profile remained high, with no significant difference among pump types. The right ventricular stroke work index and right heart failure scores indicated poor RV function in all groups. After 3 months of LVAD + short-term RVAD support, 46.7% still required ongoing support, and only 18.5% were weaned from RVAD support; 33.1% died. CONCLUSIONS: The mortality rate after BiVAD support was high. Survival rates and adverse events were statistically not different among the investigated groups. In the future, composite study end points examining quality of life and adverse events beyond survival may help in shared decision-making prior to general mechanical circulatory support, particularly in patients with BiVAD implants.
OBJECTIVES: The purpose of this study was to describe pre- and postoperative data from the EUROMACS registry with regard to indications, for and survival and complication rates of patients with primary continuous flow and pulsatile biventricular long-term assist devices (BiVADs) versus total artificial hearts (TAHs) or left ventricular assist devices (LVADs) + short-term right ventricular assist device (RVAD) implants. METHODS: We investigated patients who received implants between 1 January 2011 and 21 October 2017. Clinical baseline information about comorbidities, laboratory results, medical and device therapies and echocardiographic, haemodynamic and right ventricle (RV) parameters were evaluated along with the rates of deaths and complications. RESULTS: A total of 413 of 3282 patients (12.5%) needed a biventricular pump. We investigated 37 long-term BiVADs, 342 LVAD + short-term RVAD implants and 34 TAHs. Minor differences were found in the baseline characteristics of our population, which had an overall high morbidity profile. The 1-year survival rate was 55% for patients with a continuous flow BiVAD; 52% for patients with an LVAD + short-term RVAD; 37% for patients with pulsatile BiVADs; and 36% for patients with a TAH. No statistical difference was observed among the groups. Over 50% of patients with BiVAD support were classified as INTERMACS profiles 1 and 2. The percent of patients with ambulatory heart failure (INTERMACS 4‒7) undergoing BiVAD implants was modest at <15%. No patients with a pulsatile BiVAD (n = 15) or a TAH (n = 34) were implanted as destination therapy, but 27% of the patients with continuous flow BiVADs (n = 6) and 23% of the patients with LVAD + short-term RVAD (n = 342) were implanted as 'destination'. The adverse events profile remained high, with no significant difference among pump types. The right ventricular stroke work index and right heart failure scores indicated poor RV function in all groups. After 3 months of LVAD + short-term RVAD support, 46.7% still required ongoing support, and only 18.5% were weaned from RVAD support; 33.1% died. CONCLUSIONS: The mortality rate after BiVAD support was high. Survival rates and adverse events were statistically not different among the investigated groups. In the future, composite study end points examining quality of life and adverse events beyond survival may help in shared decision-making prior to general mechanical circulatory support, particularly in patients with BiVAD implants.
Authors: Mark S Goodin; Michael S Showalter; David J Horvath; Barry D Kuban; Christine R Flick; Anthony R Polakowski; Kiyotaka Fukamachi; Jamshid H Karimov Journal: ASAIO J Date: 2021-11-10 Impact factor: 3.826
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