Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients

Abstract

Background: The NuPulseCV intravascular ventricular assist system (iVAS) provides extended duration ambulatory counterpulsation via a durable pump placed through the distal subclavian artery. Methods: We performed a prospective, single-arm, multicenter, US Food and Drug Administration-approved feasibility trial of iVAS therapy as a bridge to transplant or decision following the FIH (First-In-Human) trial. Results: Forty-seven patients were enrolled, and 45 patients (median 61 years old, 37 males, and 30 listed on United Network of Organ Sharing) received iVAS support for median 44 (25–87) days. There were no intraoperative complications. Success was defined as survival or transplant on iVAS therapy free from disabling stroke. Outcome success at 30 days (the primary end point of this study) and at 6 months was 89% and 80%, respectively. During 6 months of iVAS support, 2 patients died and 2 patients experienced disabling neurological dysfunction. Six-minute walk distance, 2-minute step test, and Kansas City Cardiomyopathy Questionnaire score improved during 4-week iVAS support. Conclusions: This feasibility trial demonstrated promising short-term outcomes of iVAS therapy with improved functional capacity and quality of life during the therapy. Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT02645539.

Intra-Aortic Balloon Pumping in Acute Decompensated Heart Failure With Hypoperfusion: From Pathophysiology to Clinical Practice

“…This treatment, which has been employed in patients with advanced HF eligible to HT with acceptable short-term outcomes, combines the advantages of aortic counterpulsation with the possibility of outof-hospital ambulatory support. 99 The ongoing feasibility study (REGISTRATION: URL: https://www. clinicaltrials.gov; Unique identifier: NCT02645539) will enrich our knowledge on safety and efficacy of this device and possibly also on the long-term effects of counterpulsation.…”

Ambulatory short-term mechanical circulatory support: facilitates recovery and prepares patients for definitive therapy

“…There was one mortality and one CVA during this study period [ 16 ]. Interestingly, the NuPulse iVAS is a successor to the Kantrowitz CardioVAD [ 17 ], which was plagued by air embolism and stroke after 4 to 6 months of implant. If anything, the iVAS experience is very similar, suggesting that the use of compressed air beyond a few weeks is potentially dangerous in terms of air-embolism risk.…”

Temporary mechanical circulatory support devices: practical considerations for all stakeholders

“…Temporary MCS in the ambulatory setting is an area of investigation intended to facilitate physical rehabilitation and allow outpatient support while the patient awaits cardiac recovery or more definitive therapy. The Intravascular Ventricular Assist System (iVAS; NuPulse) 99 is an extended use, minimally invasive, ambulatory IABP intended to be used as a bridge to transplantation. The initial feasibility trial demonstrated early positive experiences with the device 100 , and larger investigations are underway.…”