Propensity score‐based analysis of long‐term outcome of patients on HeartWare and HeartMate 3 left ventricular assist device support

Abstract

Aims Left ventricular assist device therapy has become the cornerstone in the treatment of end-stage heart failure and is increasingly used as destination therapy next to bridge to transplant or recovery. HeartMate 3 (HM3) and HeartWare (HVAD) are centrifugal continuous flow devices implanted intrapericardially and most commonly used worldwide. No randomized controlled trials have been performed yet. Analysis based on large registries may be considered as the best alternative but has the disadvantage of different standard of care between centres and missing data. Bias is introduced, because the decision which device to use was not random, even more so because many centres use only one type of left ventricular assist device. Therefore, we performed a propensity score (PS)-based analysis of long-term clinical outcome of patients that received HM3 or HVAD in a single centre. Methods and results Between December 2010 and December 2019, 100 patients received HVAD and 81 patients HM3 as primary implantation at the University Medical Centre Utrecht. We performed PS matching with an extensive set of covariates, resulting in 112 matched patients with a median follow-up of 28 months. After PS matching, survival was not significantly different (P = 0.21) but was better for HM3. The cumulative incidences for haemorrhagic stroke (P = 0.01) and pump thrombosis (P = 0.02) were significantly higher for HVAD patients. The cumulative incidences for major bleeding, ischaemic stroke, right heart failure, and driveline infection were not different between the groups. We found no interaction between the surgeon who performed the implantation and survival (P = 0.59, P = 0.78, and P = 0.89). Sensitivity analysis was performed, by PS matching without patients on preoperative temporary support resulting in 74 matched patients. This also resulted in a non-significant difference in survival (P = 0.07). The PS-adjusted Cox regression showed a worse but non-significant (P = 0.10) survival for HVAD patients with hazard ratio 1.71 (95% confidence interval 0.91-3.24). Conclusions Survival was not significantly different between both groups after PS matching, but was better for HM3, with a significantly lower incidence of haemorrhagic stroke and pump thrombosis for HM3. These results need to be interpreted carefully, because matching may have introduced greater imbalance on unmeasured covariates. A multicentre approach of carefully selected centres is recommended to enlarge the number of matched patients.

When Nothing Goes Right: Risk Factors and Biomarkers of Right Heart Failure after Left Ventricular Assist Device Implantation

“…Although it did not reach a statistical level of significance, a trend toward lower daily beta blocker doses were observed in patients with the HM3 compared to those with the HVAD device (3.75 mg vs. 5 mg; p = 0.085). We hypothesized that the results of previous clinical trials demonstrating the superiority of the HM3 device with respect to thromboembolic events [ 11 , 12 , 13 , 14 ] may have led to differences in the stringency of blood pressure management and thus lower doses of beta blockers in patients implanted with the HM3. Thus, our results suggest that it is not the device design per se, but differences in best practices in patient care that lead to a lower incidence of RHF in patients with the HM3 device.…”

“…On the other hand, a less invasive surgical implantation strategy has been suggested to have a protective effect on the development of RHF after LVAD implantation [ 10 ]. Recent studies have suggested the superiority of the HeartMate 3 (HM3) (Abbott Inc., Chicago, IL, USA) over the HVAD (Medtronic Inc., Minneapolis, MN, USA) device in terms of the occurrence of thromboembolic events [ 11 , 12 , 13 , 14 ]; however, other analyses have failed to identify substantial differences [ 15 ]. A possible superiority of the HM3 vs. HVAD device in terms of the development of RHF has not been investigated.…”

Prognostic impact of functional mitral regurgitation prior to left ventricular assist device implantation

“…Additionally, all of those patients suffered from progressive heart failure or ongoing cardiogenic shock and were classified as INTERMACS class I or II. Furthermore, a high proportion of HVAD implantations within the current analysis might have negatively influenced long-term survival, as there is growing evidence of a higher frequency of neurological adverse events and mortality among HVAD recipients as compared to other commercially available durable LVADs [ 31 ].…”

Doing the wrong thing for the right reasons: The demise of the HVAD

“…Although there are no prospective, comparative clinical trials of HVAD and HeartMate 3, there is a growing body of evidence that clinicians favor the more recently introduced device. Numan and colleagues 13 analyzed a propensitymatched cohort of patients with Heartmate 3 and HVAD and found no difference in survival but greater rates of pump thrombosis and hemorrhagic stroke with HVAD. Analyses of the Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) registry using propensity-matched populations implanted between 2017 and 2019 have also recently demonstrated that HVAD is associated with a 5-to 6-fold increase in stroke and a 3.2fold increase in mortality relative to HeartMate 3.…”