Adult: Mechanical Circulatory Support
A multicenter evaluation of external outflow graft obstruction with a fully magnetically levitated left ventricular assist device

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Abstract

Background

The HeartMate 3 (HM 3; Abbott) left ventricular assist device (LVAD) has improved hemocompatibility-related adverse outcomes. In sporadic cases, external compression of the outflow graft causing obstruction (eOGO) can result from substance accumulation between the outflow graft and its bend relief. We sought to evaluate the prevalence, course, and clinical implications of eOGO in an international study.

Methods

A multicenter retrospective analysis of HM 3 LVADs implanted between November 2014 and April 2021 (n = 2108) was conducted across 17 cardiac centers in 8 countries. We defined eOGO as obstruction >25% in the cross-sectional area in imaging (percutaneous angiography, computed tomography, or intravascular ultrasound). The prevalence and annual incidence were calculated. Serious adverse events and outcomes (death, transplantation, or device exchange) were analyzed for eOGO cases.

Results

Of 2108 patients, 62 were diagnosed with eOGO at a median LVAD support duration of 953 (interquartile range, 600-1267) days. The prevalence of eOGO was 3.0% and the incidence at 1, 2, 3, 4, and 5 years of support was 0.6%, 2.8%, 4.0%, 5.2%, and 9.1%, respectively. Of 62 patients, 9 were observed, 27 underwent surgical revision, 15 underwent percutaneous stent implantation, 8 received a heart transplant, and 2 died before intervention. One patient underwent surgical revision and later stent implantation. The mortality with therapeutic intervention was 9/53 (17.0%).

Conclusions

Although uncommon, HM 3 LVAD-supported patients might develop eOGO with an increasing incidence after 1 year of support. Although engineering efforts to reduce this complication are under way, clinicians must maintain a focus on early detection and remain vigilant.

Section snippets

Study Design

This was a multicenter, retrospective study for which we collected data from patients supported with a fully magnetically levitated centrifugal-flow HM 3 LVAD. The study was approved by the institutional review board of each of the 17 participating centers in Austria, the Czech Republic, Denmark, Germany, Italy, Saudi Arabia, the Netherlands, and the United States. The authors vouch for the complete and accurate acquisition of all the data, the validity of the results, and the conclusion. The

Patients

Seventeen centers participated in this study. From June 2014 through March 2021, a total of 2108 patients received an implanted HM 3 LVAD, and of these, 62 patients (2.9%) were diagnosed with eOGO during the course of the study period. The mean support time until the eOGO diagnosis was 953.4 ± 462.5 days, and baseline characteristics and detailed surgical techniques used are described in Table E1 and Table 1. A full sternotomy was performed in most of the patients (83.87%). In 56 patients the

Discussion

The principal findings of this international collaborative analysis suggest that eOGO occurs sporadically, varies in prevalence and incidence according to center, and has an overall prevalence of 3.0%. Importantly, this complication has an increasing incidence as time of LVAD support grows. We confirm that the overall incidence is comparable with that previously reported.10 Recently published data from large registries show that the overall survival of eOGO patients is similar to that of all

Conclusions

eOGO caused by compression of gelatinous substance between the outflow graft and the bend relief is an uncommon but potentially life-threatening complication in HM 3 LVAD patients who require prolonged support (Figure 6). These findings suggest that centers should develop a standardized strategy of surveillance to screen HM 3 LVAD patients for eOGO and that imaging should be performed without delay when this complication is suspected. Although engineering efforts to reduce this complication are

References (22)

  • E.V. Potapov et al.

    Propensity score-based analysis of long-term follow-up in patients supported with durable centrifugal left ventricular assist devices: the EUROMACS analysis

    Eur J Cardiothorac Surg

    (2021)
  • Cited by (0)

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