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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.

SUBMITTER: Numan L

PROVIDER: S-EPMC8006731 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe HeartMate 3 (HM3) left ventricular assist device (LVAD) (Abbott, Inc, Chicago, Ill) is a fully magnetically levitated centrifugal implantable pump used to treat patients with chronic heart failure. The MOMENTUM (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) trial demonstrated that patients treated with the HM3 experienced reduced need for reoperation for LVAD replacement compared with a control group receiving an axial flow design, Heartmate II (Abbott, Inc). However, there are few reports of using HM3 as the replacement pump in patients who already are supported by a durable LVAD and experience a device-related complication necessitating replacement.MethodsAn institutional LVAD database was used to identify 19 consecutive patients who underwent pump replacement to HM3 (group 1) versus 85 consecutive control patients who underwent pump replacement to either Heartmate II or HeartWare Ventricular Assist Device (Medtronic Inc, Minneapolis, Minn) (group 2), at a single institution from January 2010 to August 2018. Patient baseline characteristic and outcomes were obtained from a prospectively maintained database. The primary endpoint was a composite of freedom from death or need for another replacement surgery.ResultsThere was no difference between the groups in heart failure etiology, indication for replacement, as well as the average days on the previous pump or the type of previous pump. The HM3 group did have a significantly greater body mass index (37 vs 31.6 P = .01), a greater number of previous LVAD implants (36.8% vs 5.9%, had 2 previous LVADs, P < .001), and a greater number of previous sternotomies (31.6% vs 7.1%, had 3 previous sternotomies, P = .001). No difference was found between the groups in terms of postoperative adverse event rates. With regards to the primary endpoint, the patients with HM3 replacements (group 1) versus group 2 experienced significantly greater freedom from either death or need for another replacement during the follow-up period (P = .039). During follow-up, there were no thrombosis events for the patients who received replacement with HM3.ConclusionsLVAD replacement with HM3 can be performed safely and may be considered as the pump of choice in patients requiring LVAD replacement.

Project description:IntroductionAlthough anticoagulation therapy is mandated after implantation of a left ventricular assist device (LVAD), postoperative bleedings and reoperations occur relatively frequently and are associated with worse outcomes. We evaluated the use of a conservative postoperative anticoagulation protocol in patients implanted with a HeartMate 3 (HM3) LVAD.MethodsIn a single-centre retrospective analysis of postoperative outcomes after HM3 LVAD implantation, a standard (old) anticoagulation protocol (i.e. early, full-dose anticoagulation with low-molecular weight heparin and overlapping vitamin K antagonist) was compared with a new conservative anticoagulation protocol (i.e. slow initiation of vitamin K antagonists without overlapping heparin). Main outcomes were changes in international normalised ratio (INR), lactate dehydrogenase (LDH), bleeding and/or tamponade events requiring reoperation, length of stay and adverse events.ResultsIn total, 73 patients (48 in old vs 25 in new protocol group) were evaluated. Mean age was 56 years (standard deviation 13) and most patients (78%) were males. Changes in INR and LDH in the first 14 days were similar in both groups (p = 0.50 and p = 0.997 for interaction, respectively). Number of bleeding/tamponade events requiring reoperation was lower in the new than in the old protocol group (4% vs 33%, p = 0.005). Postoperative 30-day mortality was similar, and we observed no thromboembolic events. Median (25th-75th percentiles) total length of postoperative hospital stay (27 (25-41) vs 21 (19-27) days, p < 0.001) and length of intensive care unit stay (5 (2-9) vs 2 (2-5) days, p = 0.022) were significantly shorter in the new protocol group.ConclusionThese retrospective data suggest that conservative slow initiation of anticoagulation therapy after HM3 LVAD implantation is associated with less bleeding/tamponade events requiring reoperation, a similar safety profile and a shorter duration of stay than the currently advised standard anticoagulation protocol.