Outcomes from a recovery protocol for patients with continuous-flow left ventricular assist devices

https://doi.org/10.1016/j.healun.2018.11.001Get rights and content

BACKGROUND

In this retrospective analysis we evaluated a standardized echocardiographic assessment and an invasive technique for patient selection for successful continuous-flow left ventricular assist device (CF-LVAD) explantation.

METHODS

Inclusion criteria for LVAD recovery assessment were: clinically stable condition; LVAD support for >6 months; physical activity; normal echocardiography findings; and no more than mild valvular disease and aortic valve opening. In a second step, echocardiography was performed under CF-LVAD reduction and stop conditions (PStopE). In the third step, patients who presented with stable parameters underwent right heart catheterization under CF-LVAD stoppage and occlusion of the outflow graft with a balloon catheter. Criteria for explantation were normal pulmonary artery pressure and pulmonary capillary wedge pressure <16 mmHg.

RESULTS

Thirty-three of 424 patients entered the second step of evaluation and 20 entered the third step. Fourteen presented positive results and the pump was successfully explanted. The PCWP at baseline was 8.5 (2.8) mmHg in the explantation group and 10.6 (2.8) mmHg in the non-explantation group (p = 0.105). It increased to 10.9 (3.0) mmHg vs 20.8 (4.9) mmHg under outflow graft occlusion. The wedge pressure was significantly higher in the non-explantation group (p < 0.001). Median duration of follow-up after explantation was 9.74 (interquartile range 4.3 to 20.60) months, with survival of 93%.

CONCLUSIONS

The protocol presented is feasible and safe. The criteria applied provide good patient selection for sustained mid-term myocardial recovery after LVAD explantation.

Section snippets

Methods

The standard evaluation protocol at our center consists of 3 consecutive steps (refer to Figure 2). This study is a retrospective analysis of the data of all patients who underwent the evaluation process between January 2016 and April 2018. The study was reviewed and approved by the ethics commission at Charité University. Because this was a retrospective study, informed consent from the patients was not required.

Results

Between January 2016 and April 2018, 424 patients with LVADs (279 HeartWare HVAD, 52 HeartMate II, and 93 HeartMate 3) were screened as a first step in our outpatient department. Thirty-three (7.8%) patients went into second-step evaluation (20 males, 13 females). Patients were supported with either HeartWare HVAD (n = 23), HeartMate II (n = 2), or HeartMate 3 (n = 8) devices. Implantations were performed between August 2010 and August 2017. The mean time between implantation and baseline

Discussion

In this study we have presented a retrospective analysis of the weaning protocol developed at the German Heart Center Berlin for assessment of myocardial recovery and weaning from CF-LVAD (Figure 2). The patients who entered the first step of assessment were “all-comers” from an outpatient department. Only a small proportion of our LVAD population was regarded as suitable for elective weaning (7.8%). This concurs with international registries and other retrospective studies.15, 16, 17

Disclosure statement

V.F. is a member of the medical boards of Abbott, Medtronic, and Berlin Heart, and a principal investigator for ZH Heart. T.K. reports grants from Abbott and Medtronic and honoraria for working as a proctor for Abbott and Medtronic. E.P. reports grants from Abbott and Medtronic and honoraria as a proctor for Abbott and Medtronic. The remaining authors have no conflicts of interest to disclose. We thank Anne Wölffel-Gale for editorial assistance.

References (30)

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