An Analysis of Implant Approach and Impact on Early Outcomes in Real-World Use of the HeartWare™ HVAD™ System

Abstract

Purpose The HVAD™ System is globally approved for implantation by either a sternotomy or thoracotomy approach, and the small size of the HVAD pump and extended tools available for thoracotomy access have resulted in increasing adoption of the thoracotomy implant approach. The US DT PAS study is the real-world post-approval study of the HVAD System when used in destination therapy patients. APOGEE International is a multinational real-world study of the impact of the implant procedure and patient management on HVAD outcomes. Since these studies allow for either implant approach, data from these two registries will be examined to assess the frequency of various implant approaches and the corresponding outcomes. Methods The objective of this analysis is to examine the frequency of the thoracotomy versus sternotomy implant approaches utilized in the DT PAS and the APOGEE International studies, as well as to describe the outcomes associated with each approach. At the time of presentation, we will have 258 patients with follow-up data through at least 6 months of support. Results Data is currently being collected from 50 centers in the US, EMEA, and Australia. Preliminary data from 143 patients reveals baseline parameters with a mean age 58.7 years, with 16.3% INTERMACS 1 and 44.8 % with ischemic etiology. Approximately one-third of the patients had temporary mechanical support prior to LVAD implant, and 25.9% had previous sternotomies. Implants were performed via a full sternotomy approach in 55.2% of those patients, while 0.7% were converted from thoracotomy to sternotomy, and 44.1% were implanted via a thoracotomy approach (27.3% left lateral thoracotomy (LLT) and upper hemi-sternotomy and 16.8% LLT and right thoracotomy). Data collection and analysis is ongoing, and full baseline and 6-month outcomes will be available for 258 patients at the time of presentation. Conclusion Analyses of real-world use of the HVAD System reveals its increasing use in more complex patients, as well as increasing adoption of the thoracotomy approach.