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Bariatric surgery in obese patients with ventricular assist devices

Abstract

Objectives

Patients with end-stage heart failure (ESHF) treated with ventricular assist devices (VADs) tend to gain weight, which may prevent them from receiving heart transplantation (HT) if their body mass index (BMI) reaches ≥ 35 kg/m2. The objective was to synthesize all cases available in the literature and describe the most important outcomes of bariatric surgery (BS) in VAD patients, including BMI trends, reaching a BMI < 35 kg/m2, listing for HT, achieving HT, myocardial recovery, and mortality. These data were obtained for an individual participant data (IPD) meta-analysis and include available IPD for every case in the scientific literature describing VAD patients undergoing BS during VAD support with documented postoperative BMI (and time of measurement) during follow-up.

Data description

These data include baseline, periprocedural, and long-term outcomes for the 29 patients meeting selection criteria. The composite outcome includes reaching a BMI < 35 kg/m2, listing for HT, receiving HT, and myocardial recovery, indicating significant BMI loss associated with major ESHF outcomes. As multiple centers are becoming more experienced in this field, the present data can be merged with their databases to form larger samples that will allow to perform further statistical analysis to identify outcome predictors and improve clinical protocols and outcomes.

Objective

Patients with class II obesity (body mass index; BMI ≥ 35 kg/m2) have worse outcomes after heart transplantation (HT). Hence, the International Society for Heart and Lung Transplantation considers a BMI ≥ 35 kg/m2 to be a contraindication for HT [1], excluding many obese patients with end-stage heart failure (ESHF) from transplantation, which is the gold standard therapy for this condition.

An alternative therapy for obese patients with ESHF is ventricular assist device (VAD) implantation. The BMI cutoff for VAD implantation varies among different centers and is often higher than for HT. Based on this, one would expect obese patients to undergo VAD implantation, lose weight, and undergo HT once they achieve a BMI < 35 kg/m2. However, patients with BMIs < 35 kg/m2 tend to gain weight after VAD implantation [2], which may halt their candidacy for HT if they reach a BMI ≥ 35 kg/m2.

Few small cohort studies and case reports have shown promising results of bariatric surgery (BS) in obese patients with VADs [3,4,5,6]. Nevertheless, much of the postoperative weight (and BMI) trends remains unknown in this population. This is an important knowledge gap because VAD patients receive chronic anticoagulation and are already at very high risk of thromboembolic and bleeding events at baseline [7] which increases the risk of adverse events after surgeries. In consequence, only few large centers offer this intervention to a minority of obese patients with VADs.

Therefore, this systematic review and individual participant data (IPD) meta-analysis included available IPD for every case in the scientific literature describing the outcomes of VAD patients who underwent BS with documented postoperative BMI (and time of measurement) during follow-up [8]. The aim was to evaluate the most important outcomes after BS in VAD patients, including BMI trends, listing for HT, achieving HT, myocardial recovery, and mortality.

Data description

A systematic search was conducted in PubMed, Embase, The Cochrane Library and ClinicalTrials.gov combining free keywords and official indexing terms for VADs and BS. Truncated terms were used when allowed by the engine. Additional searches were performed in Google Scholar and the online content of: The Journal of Heart and Lung Transplantation, Journal of Cardiac Failure, Obesity Surgery, Surgery for Obesity and Related Diseases, and every member of the journal groups: Journal of the American College of Cardiology, Circulation, and the European Heart Journal.

Retrieved references were transferred to EndNote X8 (Clarivate Analytics, Philadelphia, PA, USA) and Rayyan (Qatar Computing Research Institute, Doha, Qatar), and duplicates were removed. Studies of any design and publication type (abstracts, full article, registry with results…) were included if they contained IPD of postoperative BMIs of VAD patients undergoing BS. Two investigators worked in parallel and independently to select references, extract IPD, and assess the risk of bias in each study. Discrepancies were resolved by discussion.

Every study was classified according to the institution where they were conducted, publication year, sample size, number of patients that met selection criteria, publication type, and whether or not they met selection criteria, data available in Data file 1. Only non-duplicated IPD were obtained from reference(s) with largest sample size with available IPD for postoperative BMI. One patient’s IPD was included in a case report and a cohort study [9, 10], hence, such IPD were extracted from the most detailed reference [9]. When available, weight and additional anthropometric data were used to calculate BMI. All included studies had low risk of bias for the main outcome (postoperative BMI).

Data file 2 provides detailed data of the studies and baseline characteristics of patients that met selection criteria. Detailed BMI data over time, type of BS, length of follow-up, and most important clinical ESHF outcomes are available in Data file 3. These data evidence successful results of BS in obese VAD patients to achieve the composite outcome of a < 35 kg/m2, HT, listing for HT, or myocardial recovery.

Data file 4 displays graphical trends of the excess BMI lost over time after BS. Each line represents an individual patient and zero (0) corresponds to the time and baseline body mass index at the time of bariatric surgery which is the point of reference for BMI comparisons (excess BMI lost) during follow-up. This graph was developed with StataSE 14 (College Station, TX, USA). Data file 5 provides a list of the references cited in the tables.

As clinical practice and research interest in this field continues to grow, multiple centers of advanced heart failure and HT will potentially benefit from analyzing these data or merging these data with their own (single or multicenter) data to create a larger sample to perform more elaborate statistical analysis, such as regressions and subgroup analyses, to better understand the impact of BS in these obese patients with VADs and to identify predictors of major outcomes that ultimately translate into improvements in clinical practice and outcomes.

Limitations

  • As with every meta-analysis, there is a risk of publication bias of the available literature which could have biased our sample. To reduce this risk, we did not exclude abstracts and screened grey literature.

  • There is also a risk of reporting bias, especially with case reports that did not report all major outcomes of interest.

  • These data contain IPD of patients who already had VADs at the time of BS. Patients who underwent BS prior to VAD implantation or had both interventions done during the same encounter were excluded. Patients without available postoperative BMI data were excluded because the meta-analysis was centered on the BMI trends after BS. However, these data are very valuable as they provide better understanding and could even expedite future meta-analyses in the field by greatly reducing the amount of work required for data extraction and quality control. Furthermore, identifying the missing data from each reference allows to appreciate areas for improvement in the way we report studies and gaps of knowledge on this topic.

Availability of data and materials

The data described in this Data note can be freely and openly accessed on Mendeley Data under https://doi.org/10.17632/33m7sc3wnc.2 [11]. Please see Table 1 and references 8 and 11 for details and links to the data.

Table 1 Overview of data files/data sets

Abbreviations

BMI:

Body mass index

BS:

Bariatric surgery

ESHF:

End-stage heart failure

HT:

Heart transplantation

IPD:

Individual participant data

VAD:

Ventricular assist device

References

  1. 1.

    Mehra MR, Canter CE, Hannan MM, et al. The 2016 International Society for Heart Lung Transplantation listing criteria for heart transplantation: a 10-year update. J Heart Lung Transpl. 2016;35(1):1–23.

    Article  Google Scholar 

  2. 2.

    Jaiswal A, Truby LK, Chichra A, et al. Impact of obesity on ventricular assist device outcomes. J Card Fail. 2020;26(4):287–97.

    Article  Google Scholar 

  3. 3.

    Leviner DB, Keidar A, Ben-Gal T, et al. Cardiac function recovery following LVAD implantation and bariatric surgery in a morbidly obese patient. J Card Surg. 2014;29(5):740–2.

    Article  Google Scholar 

  4. 4.

    Morrow EH, Pellegrini CA, Mokadam NA, et al. Laparoscopic gastric bypass during left ventricular assist device support and ventricular recovery. J Heart Lung Transplant. 2014;33(8):870–1.

    Article  Google Scholar 

  5. 5.

    Zenilman A, Pechman D, Moran-Atkin E, et al. Bariatric surgery in patients with left ventricular assist devices: a safe and effective method of weight loss as a gateway to heart transplantation. Surg Obes Relat Dis. 2019;15(10):1780–4.

    Article  Google Scholar 

  6. 6.

    Punchai S, Nor Hanipah Z, Sharma G, et al. Laparoscopic sleeve gastrectomy in heart failure patients with left ventricular assist device. Obes Surg. 2019;29(4):1122–9.

    Article  Google Scholar 

  7. 7.

    Uriel N, Colombo PC, Cleveland JC, et al. Hemocompatibility-related outcomes in the MOMENTUM 3 Trial at 6 months: a randomized controlled study of a fully magnetically levitated pump in advanced heart failure. Circulation. 2017;135(21):2003–122.

    Article  Google Scholar 

  8. 8.

    daSilva-deAbreu A, Alhafez BA, Curbelo-Pena Y, et al. Bariatric surgery in obese patients with ventricular assist devices considered for heart transplantation: systematic review and individual participant data meta-analysis. In peer-review.

  9. 9.

    Lockard KL, Allen C, Lohmann D, et al. Bariatric surgery for a patient with a HeartMate II ventricular assist device for destination therapy. Progr Transpl. 2013;23(1):28–322.

    Article  Google Scholar 

  10. 10.

    Wikiel KJ, McCloskey CA, Ramanathan RC. Bariatric surgery: a safe and effective conduit to cardiac transplantation. Surg Obes Relat Dis. 2014;10(3):479–84.

    Article  Google Scholar 

  11. 11.

    daSilva-deAbreu A, et al. Bariatric surgery in obese patients with end-stage heart failure with ventricular assist devices. Mendeley. 2020. https://doi.org/10.17632/33m7sc3wnc.2.

    Article  Google Scholar 

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Acknowledgements

This article is part of the doctoral research thesis of Adrian daSilva-deAbreu, who is the principal investigator of this study and main author of this paper. All other authors commit to not using this publication as main part of their doctoral theses. However, this does not mean that this article cannot be used by the other authors as complement merit in their doctoral theses.

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Authors

Contributions

AdS-dA, BAA, and YC-P contributed with study design, data gathering, data processing, as well as manuscript drafting and editing. AdS-dA conducted the statistical analysis. CJL, HOV, JFL-F, and SAM contributed with interpretation of results, supervision of the study, and manuscript editing. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Adrian daSilva-deAbreu.

Ethics declarations

Ethics approval and consent to participate

Not applicable. This data was collected and processed from the available published literature as part of a meta-analysis, hence, available patient data from each study from each study should have been approved institutional review boards (bioethics committees) of author’s institutions and/or undergone patient consent.

Consent for publication

Not applicable.

Competing interests

SAM is a paid speaker for United Therapeutics Corporation and Bayer. All other authors declare no conflicts of interest related to this study.

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daSilva-deAbreu, A., Alhafez, B.A., Curbelo-Pena, Y. et al. Bariatric surgery in obese patients with ventricular assist devices. BMC Res Notes 13, 382 (2020). https://doi.org/10.1186/s13104-020-05221-z

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Keywords

  • Heart-assist devices
  • Ventricular assist devices
  • Bariatric surgery
  • Sleeve gastrectomy
  • Gastric bypass
  • Roux-en-Y gastric bypass
  • Obesity
  • Heart failure
  • Body mass index
  • Heart transplantation