Introduction:
Intravascular ventricular assist device (iVAS; NuPulse CV, North Carolina, USA) is a newly developed ambulatory and portable counter pulsation heart assist system.
Hypothesis:
Early and late clinical outcomes of iVAS is comparable to those of conventional axillary intra-aortic balloon pump (IABP) as a bridge to heart transplantation(BTT).
Methods:
Between April 2016 and January 2020, 33 patients underwent iVAS implantation (Group A) and 69 patients underwent axillary IABP (Group B) as a BTT. We reviewed perioperative data and late clinical outcomes including survival. Long-term survival was assessed with the Kaplan-Meier analysis.
Results:
The patients in Group A was significantly older than Group B (A: 58.8±8.1 vs B: 53.3±14.7 p=0.048). The use of inotropes at the time of device implantation was similar between two groups (A:22/33(66.7%) vs B: 47/69(68.1%), p=0.88). Almost all patients were able to ambulate and participate in physical therapy (A:100% vs B:97.1%, p=0.21). The duration of device support in Group A was significantly longer than Group B (A:83.3±93.7 vs B:19.0±13.3 days, p <0.01). After a FDA approval, eleven patients (44%) in Group A was able to be discharged with an iVAS. While waiting for transplantation, 3 patients expired in Group A and none in Group B. Two patients in Group A required an escalation of support (ECMO N=1, LVAD N=1) and 1 patients in Group B (percutaneous LVAD N=1). Balloon exchange due to device related complications was required less frequently in Group A compared to Group B (A: 2/33, 6.1% vs B: 20/69, 29.0% p <0.01). Adverse events during balloon exchange included aortic rupture (N=1) and type A aortic dissection (N=1) (all in Group B). The success rate of BTT was not significantly different between groups (A:27/32(84.4%), B: 64/68(94.1%),p=0.13). The long-term survival after heart transplantation did not differ between the groups (A: 78.1% at 3 years vs B: 83.8% at 3 years, log-rank=0.07).
Conclusions:
Both iVAS and conventional axillary IABP showed comparable long-term survival and decent success rates of BTT. The iVAS featured with the portable mechanism might be a promising option as a BTT.
Outcomes of Heart Transplantation after Long-Term Circulatory Support by Ventricular Assist Devices with Driveline/Pump Infection
