A Multicenter Analysis of Implantation via a Thoracotomy Approach of a Left Ventricular Assist System for the Treatment of Advanced Heart Failure

Objectives: Less invasive nonsternotomy approaches are becoming increasingly popular procedures for implanting left ventricular assist devices (LVADs) during end-stage heart failure treatment. The HeartWare HVAD Pump is a miniaturized, centrifugal-flow, intrapericardial LVAD that has been successfully implanted in advanced heart failure patients using both thoracotomy and sternotomy approaches. The objective of this study is to retrospectively evaluate the clinical safety and performance of the HVAD System when implanted via a thoracotomy approach across multiple clinical centers.

Methods: Data were retrospectively collected from 282 patients (average age = 55.8 years; male = 85%) implanted with an HVAD System via a lateral thoracotomy approach at nine centers in Europe and Australia. Sixty-three per cent of patients were classified as INTERMACS classes 1 to 3, and 11% were on ECMO at the time of implant. Ischemic heart failure was the most common etiology (55% of patients) and 33% had prior cardiac surgery. Baseline clinical and demographic characteristics were evaluated by descriptive statistics. Survival rates for the long-term cohort were analyzed using Kaplan–Meier’s methodology. Adverse events were reported as events per patient year (EPPY).

Results: A 30-, 180-, 365-, 545-, and 730-day outcomes were 90.3, 83.1, 78.9, 76.0, and 71.8%, respectively. Total bleeding events were observed at 0.11 EPPY. Hemolysis was infrequent and reported in two patients. Total infections occurred at 0.17 EPPY. Total neurologic dysfunction was reported at 0.13 EPPY. Only 14.5% patients were transplanted by 2 years. Not surprising, the survival of patients on ECMO at the time of implant was lower, with 1 year survival at 56%, compared with 82% in case of patients not on ECMO.

Conclusion: The data from this study corroborate reports from the LATERAL Clinical Trial on 144 patients implanted with the HVAD System in the United States and Canada via the thoracotomy approach and support the excellent outcomes observed with the HVAD System. This analysis of real world use of the HVAD System implanted via a thoracotomy approach demonstrates the safety of this implantation approach for treating advanced heart failure patients.

No conflict of interest has been declared by the author(s).