A Long-Term Counterpulsation Heart Assist System Used as a Bridge to Decision in Advanced Congestive Heart Failure

Abstract

Purpose The intravascular ventricular assist system (iVAS) is a minimally invasive, ambulatory, counterpulsation heart assist system that is inserted through the subclavian artery and sits in the descending aorta. It has been evaluated in a feasibility trial with expanded indications to include patients who were a bridge to decision (BTD). The objective was to evaluate the role of iVAS as a BTD device. Methods As part of a multicenter US FDA approved feasibility trial, 13 of 44 patients were implanted with iVAS as a BTD. Patients were in advanced congestive heart failure (CHF), did not have an irreversible contraindication to transplant, and were not listed at the time of implantation. Results Four patients were bridge to candidacy (BTC) due to substance abuse - three received a transplant and one is still in a probationary period. Two patients were Jehovah's Witnesses who needed their anemia and end organ function to improve prior to escalation of therapy. Both had comorbidities that precluded transplant and they received a left ventricular assist device (LVAD). One patient was implanted for recovery but the anatomy of his aorta proved incompatible with an iVAS and he received a LVAD. Two patients were initially too frail to receive a LVAD or transplant - one improved and received a transplant and the other is ongoing as a BTC. Two patients received an iVAS for intractable angina. One patient had transplant arteriopathy but also had severe peripheral vascular disease that precluded transplant. The iVAS was explanted after a year and symptom improvement. The other patient had nonrevascularizable coronary disease and had relief of his angina but died suddenly at home from an unknown cause. Two patients had cardiogenic shock after myocardial infarction and were supported for over 6 months. The average duration of iVAS support was 129 ± 101 days. At the time of iVAS implant, 8/13 patients had contraindications to LVAD. At 6 months, 11/13 had been successfully supported with iVAS and reached the intended goal. Conclusion The utility and versatility of the iVAS as a BTD was demonstrated in this trial. Outcomes were excellent in very challenging patients, many with contraindications for LVADs. The iVAS allowed a variety of patients time to improve their physical condition and transplant candidacy and is an important adjunct in treating complex advanced CHF patients.