Abstract
Background
Durable Left ventricular assist devices (LVADs) are commonly employed as therapy in end-stage heart failure (ESHF). However, individuals with class II obesity (Body Mass Index (BMI) > 35 kg/m²) are often ineligible for heart transplant and have limited options. Laparoscopic sleeve gastrectomy (LSG) is increasingly utilized to facilitate weight loss and improve transplant candidacy. This study evaluates the safety of performing LSG in patients undergoing LVAD implantation who are otherwise ineligible for heart transplantation due to morbid obesity.
Methods
A retrospective, single-center cohort study was conducted on congestive heart failure (CHF) patients who underwent either simultaneous LVAD and LSG or staged LSG following LVAD placement. The primary outcome was LSG-related complications within 90 days, including gastrointestinal (GI) bleeding, staple line leaks, and mortality. Secondary outcomes included reoperation rates, acute kidney injury (AKI), transfusion requirements, length of stay (LOS), readmissions, transplant rates, and percent excess body weight loss (%EBWL) at follow-up.
Results
Among 77 patients (54 simultaneous, 23 interval), LSG-related complications were lower in the simultaneous group (7.4% vs. 17.4%; p = 0.23). Transfusion rates were significantly lower in this group (38.9% vs. 69.6%; p = 0.02), though AKI was more frequent (72.2% vs. 56.6%; p = 0.19). One mortality occurred in the simultaneous cohort. No significant differences were observed in reoperations, LOS, readmissions, transplant rates, or %EBWL.
Conclusion
Simultaneous LVAD/LSG was associated with comparable sleeve-related complication rates relative to interval LSG. Although limited by small sample size and potential temporal confounding, these findings hypothesize that simultaneous LVAD/LSG may potentially be a feasible strategy in select patients with obesity and ESHF. Larger prospective studies are needed to better define safety, patient selection, and long-term outcomes.
Key Points
Simultaneous LVAD and LSG did not increase complications.
Simultaneous LVAD and LSG is a viable option for obese heart failure patients.
Simultaneous LVAD and LSG may improve transplant candidacy.
Introduction
Heart transplantation is the gold standard treatment for patients with ESHF, offering significant improvements in both survival and quality of life [1]. However, eligibility is limited by several factors, with obesity being a well-recognized contraindication [2]. Specifically, a BMI greater than or equal to 35 kg/m² is associated with increased perioperative complications and worse outcomes, and thus commonly disqualifies patients from transplant listing [3–5].
For patients with obesity who are not immediate transplant candidates, durable LVADs are often used as a bridge-to-transplant or as a destination therapy strategy [6]. While LVADs provide critical hemodynamic support, many patients struggle to achieve the necessary weight loss after implantation [7–9]. Contributing factors include limited mobility, physical deconditioning, and psychosocial issues such as depression [10–12]. As a result, a considerable number of these patients may never reach transplant eligibility [13]. Bariatric surgery, particularly LSG, has been increasingly explored in this population as a means to facilitate weight loss and improve transplant candidacy. Our prior experience has shown that performing LSG after LVAD implantation is both feasible and effective in selected patients [14, 15]. However, staged procedures require multiple hospitalizations and surgeries, increasing overall risk and resource utilization.
Importantly, any surgical intervention in LVAD patients presents challenges, most notably the need to manage perioperative anticoagulation to mitigate both bleeding and thrombotic complications. Furthermore, LVADs are associated with device-specific risks, including driveline infections and pump thrombosis [16, 17]. This study aims to evaluate the safety and feasibility of performing LSG simultaneously with LVAD implantation. The rationale for this approach lies in minimizing the cumulative risk of multiple surgical interventions, reducing time to transplant eligibility, and potentially lowering healthcare utilization. By combining these procedures into a single operative event, we hypothesize that patients may experience improved outcomes through earlier weight loss, reduced exposure to repeated anesthesia and hospitalization, and a potentially shorter time to heart transplant.
Methods
We conducted a single-center, retrospective cohort study evaluating outcomes in adult patients with obesity and ESHF who underwent LVAD implantation as destination therapy. Inclusion criteria consisted of adult patients aged 18 years or older with a BMI greater than 35 kg/m² and a diagnosis of ESHF requiring LVAD support. Patients were excluded if they required revisional bariatric procedures, had severe psychiatric comorbidities, cirrhosis, or were pregnant.
Participants were categorized into two groups based on the timing of the LSG in relation to LVAD implantation. The intervention group underwent simultaneous LVAD implantation and LSG during the same operative and anesthetic event. In contrast, the control group received an interval LSG, which was performed at a later date following LVAD implantation. All patients completed standard preoperative evaluations, including assessments for both cardiac and bariatric surgery suitability.
All LSG operations were performed using a standardized four-port laparoscopic technique. Gastric transection was accomplished using serial applications of appropriate height GI staples with absorbable staple line reinforcement over a 40-Fr bougie for calibration. Routine postoperative upper gastrointestinal (UGI) imaging was not performed. Postoperatively, all patients were extubated and initiated on a clear liquid diet for the first three days, followed by a full liquid diet for two weeks. They then progressed to a pureed diet for an additional three weeks before transitioning to solid food. Therapeutic anticoagulation was initiated between 12 and 24 h after surgery.
The primary outcome was the occurrence of sleeve-related complications within 90 days following surgery. These complications included postoperative bleeding, staple line leak, intra-abdominal abscess, or death. Postoperative bleeding was defined as either intraluminal GI bleeding, indicated by hematemesis or melena requiring.
esophagogastroduodenoscopy (EGD), or extraluminal bleeding, identified by active bleeding or hematoma on computed tomography (CT) imaging. A staple line leak was defined by the presence of oral contrast extravasation on UGI series or CT imaging. Intra-abdominal abscess was defined as a fluid collection seen on imaging studies. All-cause mortality within the 90-day postoperative period was also included in the primary outcome.
Secondary outcomes included the proportion of patients who achieved a BMI less than 35 kg/m², rate of heart transplantation, incidence of unplanned readmissions and reoperations, development of AKI, need for postoperative blood transfusions, length of hospital stay following surgery, %EBWL, and %TBWL at the most recent follow-up.
The primary outcome was analyzed using Fisher’s exact test, while secondary outcomes were analyzed with Fisher’s exact test or generalized linear models. All statistical analyses were performed using R and RStudio.
Results
A total of 77 individuals met inclusion criteria for this study between 2013 and 2023. Of these, 54 patients underwent simultaneous LVAD implantation with LSG, while 23 patients underwent interval LSG following prior LVAD implantation. The median time from LVAD implantation to LSG in the interval group was 18 months (540 days). Baseline demographic and clinical characteristics were comparable between the two groups. Patients in the simultaneous LVAD/LSG group were slightly older on average. (Table 1) The cohort was predominantly male, and all patients had an American Society of Anesthesiologists (ASA) physical status classification of III or higher, indicating significant systemic disease. There were clinically meaningful differences observed in the prevalence of hypertension, hyperlipidemia, and obstructive sleep apnea, though these differences were not statistically significant. The median BMI at baseline was 44.7 kg/m² and was similar between the two groups. A majority of patients (82%) had heart failure secondary to non-ischemic cardiomyopathy. Over 90% of patients had a left ventricular ejection fraction (LVEF) of less than 25%, and approximately one-third had pulmonary hypertension. Patients in the interval group had a higher proportion of older LVADs implanted. As expected, simultaneous LVAD/LSG had longer operative times.
Table 1.
Patient demographics
| Overall (N=77) | LVAD/SG (N=54) | Interval SG (N=23) | P-Value | |
|---|---|---|---|---|
| Age (year), Mean (SD) | 44.5 (11.3) | 46.3 (11.7) | 40.4 (9.6) | 0.03 |
| Sex-Male | 62% | 68% | 48% | 0.12 |
| ASA Class ≥ 3 | 100% | 100% | 100% | 1.00 |
| Cause of Heart Failure | ||||
| Ischemic | 18% | 20% | 13% | 0.53 |
| Non-ischemic | 82% | 80% | 87% | |
| LVEF | ||||
| <20% | 56% | 59% | 48% | 0.50 |
| 20-25% | 35% | 30% | 48% | |
| 25-30% | 6% | 7% | 4% | |
| >30% | 3% | 4% | 0% | |
| Pulmonary HTN | 30% | 35% | 17% | 0.17 |
| Diabetes Mellitus | 42% | 43% | 39% | 0.81 |
| HTN | 73% | 80% | 57% | 0.05 |
| HLD | 39% | 46% | 22% | 0.07 |
| CKD | 31% | 30% | 35% | 0.79 |
| CVA | 19% | 20% | 17% | 1.00 |
| Arrhythmia | 35% | 35% | 35% | 1.00 |
| OSA | 40% | 46% | 26% | 0.13 |
| BMI (kg/m2), Mean (SD) | 44.7 (6.5) | 45.1 (6.6) | 43.8 (6.3) | 0.42 |
| Durable LVAD implanted, No. (%) | ||||
| HeartWare HVAD | 30 (39%) | 17 (22.1%) | 13 (16.9) | NA |
| HeartMate II | 25 (32.5%) | 16 (20.8%) | 9 (11.7%) | |
| HeartMate III | 22 (28.6%) | 21 (27.3%) | 1 (1.3%) |
LVAD: Left ventricular assist device. SG: Sleeve Gastrectomy, SD: Standard devition, LVEF: Left ventricular ejection fraction, HTN: Hypertension, HLD: Hyperlipidemia, CKD: Chronic kidney disease, CVA: Cerebrovascular accident, OSA: Obstructive sleep apnea, BMI: Body mass index
With respect to the primary outcome, patients in the simultaneous LVAD/LSG group experienced a lower rate of sleeve-related complications within 90 days postoperatively compared to the interval group (7.4% vs. 17.4%) (OR = 0.38, p = 0.23). Although this difference did not reach statistical significance, it was clinically meaningful, with an odds ratio of 0.38 suggesting a potential protective effect of simultaneous surgery. Breakdown of sleeve-related complications revealed that GI bleeding occurred in three patients in the simultaneous group and in four patients in the interval group. All bleeding episodes were managed successfully with endoscopic intervention with none requiring reoperation. There was one postoperative death in the simultaneous group, attributed to a combination of Epstein–Barr virus (EBV) viremia complicated by encephalopathy and vancomycin-resistant Enterococcus (VRE) bacteremia, which progressed to septic shock. There were no deaths in the interval group.
Overall, 80% of patients achieved a BMI of less than 35 kg/m² by their most recent follow-up. The proportion of patients reaching this target BMI was similar between the groups: 81% in the simultaneous group and 78% in the interval group. With regards to cardiac outcomes, 29% of the total cohort underwent heart transplantation, 3% experienced sufficient cardiac recovery to allow for LVAD explantation, and 5% of patients died. The remaining patients continued to await transplantation at the time of analysis. Although the interval group had a higher proportion of patients who ultimately underwent heart transplantation, this group also experienced a higher mortality rate. Among patients who were transplanted, the mean time to transplantation was 32 months with those in the simultaneous group achieving shorter wait times compared to those in the interval group.
Moreover, patients in the simultaneous group required fewer postoperative blood transfusions but exhibited a higher incidence of AKI. Rates of hospital readmission, unplanned reoperation, LOS, %EBWL, and %TBWL were comparable between the two groups. Importantly, the majority of perioperative complications were attributable to the LVAD implantation rather than the LSG and none of the unplanned reoperations were related to the LSG procedure (Table 2).
Table 2.
Post-operative outcomes of simultaneous versus interval sleeve gastrectomy on patients undergoing LVAD placement
| Post-operative outcomes | Simultaneous LVAD/SG N=54 | Interval SG N=23 | Odd ratio (95% CI)* | P-Value |
|---|---|---|---|---|
| Sleeve related complications No. (%) (Bleeding/Death) | 3/1 (7.4%) | 4/0 (17.4%) | 0.38 (0.09 to 1.67) | 0.23 |
| Reoperations, No. (%) | 16 (29.6%) | 7 (30.4%) | 0.96 (0.33 to 2.79) | 1.00 |
| Acute kidney injury, No. (%) | 39 (72.2%) | 13 (56.6%) | 2.00 (0.72 to 5.52) | 0.19 |
| Transfussions, No. (%) | 21 (38.9%) | 16 (69.6%) | 0.28 (0.10 to 0.79) | 0.02 |
| Length of stay, days, median (IQR) | 19 (15-27) | 21 (18-26) | NA | 0.52 |
| Readmission, No. (%) | 36 (66.6%) | 14 (60.9%) | 1.29 (0.47 to 3.53) | 0.79 |
| Rate of transplantation, No. (%) | 14 (25.9%) | 9 (39.1%) | 0.54 (0.19 to 1.53) | 0.28 |
| % EBWL, mean (SD) | 55 (23) | 58 (23) | NA | 0.58 |
LVAD: Left ventricular assist device, SG: Sleeve gastrectomy, IQR: interquartile range, % EBWL: Percent excess body weight loss, SD: Standard deviation, *Interval SG represents the control for odds ratio calculation
Discussion
This study aimed to assess the safety and feasibility of performing simultaneous LSG at the time of LVAD placement in patients with ESHF and class II obesity. Our findings suggest that simultaneous LVAD/LSG does not significantly increase the risk of LSG-related complications compared to interval LSG, and in fact, may offer several potential benefits, including a lower transfusion rate and a shorter time to heart transplantation.
The primary outcome focused on the 90-day postoperative complications related to SG. Our findings showed a lower rate of complications in the simultaneous group versus the interval LSG groups, however, these were statistically not significant. The rate of LSG-related complications was lower in the simultaneous LVAD/LSG group (7.4%) compared to the interval LSG group (17.4%), though this difference did not reach statistical significance. Importantly, most complications in both groups were related to the LVAD implantation itself, such as driveline infections and pump thrombosis, which have been previously documented as common complications in LVAD patients. These findings are consistent with a 2020 meta-analysis comparing simultaneous and staged laparoscopic sleeve gastrectomy (LSG) in patients with LVADs, which found no statistically significant differences in complication rates (16% vs. 23%, respectively) or overall survival (93% vs. 79%, p = 0.17) [18]. We extend these findings through a larger, single-center retrospective cohort study with a direct comparison of simultaneous versus interval LSG, including 77 patients (54 simultaneous and 23 interval), compared with 59 patients in the prior meta-analysis, of whom only 22 underwent simultaneous LVAD/LSG. In addition to a standardized 90-day LSG-specific primary endpoint, we evaluated clinically relevant outcomes including transfusion requirements, AKI, LOS, reoperations, transplant rates, and achievement of BMI < 35 kg/m². Notably, the larger number of simultaneous procedures allowed us to identify a lower transfusion rate and a trend toward higher AKI, providing additional insight into the potential perioperative tradeoffs of simultaneous LVAD implantation and LSG.
GI bleeding was the most common complication across both groups, but it was successfully managed in all cases through endoscopy, and none required repeat abdominal operations. The presence of a single death in the simultaneous group, which was unrelated to LSG, further supports the conclusion that simultaneous LVAD/LSG does not substantially increase perioperative risk, particularly when compared to the inherent risks associated with LVAD implantation alone.
One of the key findings of this study was the significant reduction in the need for transfusions in the simultaneous LVAD/LSG group (38.9% vs. 69.6%, p = 0.02). This finding is particularly relevant given the high risk of bleeding in LVAD patients, who are often on anticoagulation therapy. The lower transfusion rate in the simultaneous group may reflect better perioperative management and the potential for improved preoperative nutritional status through bariatric intervention. This could lead to a reduced need for blood products during and after surgery.The simultaneous LVAD/LSG group experienced a higher rate of AKI compared to the interval group (72.2% vs. 56.6%). While the difference was not statistically significant (p = 0.19), this trend warrants attention. AKI is a well-recognized complication in LVAD patients, and this higher rate may be attributed to the additional stress of performing two major procedures in one operative setting. The perioperative period following LVAD implantation is known to be associated with hemodynamic instability, which may have been exacerbated by the simultaneous LSG. Future studies should investigate whether modifications in surgical technique or perioperative care could mitigate this risk.
From a clinical perspective, one of the most significant outcomes is the improvement in obesity management. The majority of patients in both groups achieved a BMI of less than 35 (80% in the simultaneous group and 78% in the interval group). Achieving a BMI under 35 is essential for heart transplant eligibility and bariatric surgery has been shown to significantly improve weight loss outcomes in this population. In our study, %EBWL was similar between the two groups, suggesting that simultaneous LVAD/LSG is as effective as interval LSG in promoting weight loss.
Furthermore, the proportion of patients who were able to receive a heart transplant was comparable between the two groups, with 29% of patients undergoing transplantation, though the interval group showed a slightly higher rate of transplantation. This may be due to the longer follow-up time in the interval group, as patients in the simultaneous group had a shorter time to transplant. These findings suggest that performing bariatric surgery concurrently with LVAD implantation does not appear to impede progression toward heart transplantation and may potentially facilitate earlier transplantation by promoting weight loss, reducing obesity-related comorbidity, and improving overall transplant candidacy.
An additional consideration is the evolving landscape of heart transplant allocation and mechanical circulatory support following the 2018 United Network for Organ Sharing (UNOS) heart allocation policy revision. Since implementation of the revised allocation system, there has been increased utilization of temporary mechanical circulatory support (MCS) devices, including extracorporeal membrane oxygenation (ECMO) and percutaneous ventricular assist devices, to achieve higher waitlist priority and earlier transplantation. Therefore, the role of durable LVAD support as prolonged bridge-to-transplant therapy has shifted in contemporary practice. Nevertheless, patients with severe obesity remain a uniquely challenging population, as elevated BMI may continue to limit transplant eligibility despite hemodynamic stabilization. In this context, combined durable LVAD support and bariatric surgery may still provide a meaningful pathway toward transplant candidacy in carefully selected patients who otherwise have limited options.
Of note, there are some important limitations in our study. Notably, the interval LSG operations were predominantly performed during the early years while simultaneous LVAD/LSG were more commonly performed in later years. This procedural trend warrants consideration of the potential for temporal confounding related to the evolution of LVAD technology, perioperative management, and patient selection practices over the study period. Patients undergoing simultaneous LVAD implantation and LSG were more likely to be treated in more recent years, during which substantial advances in mechanical circulatory support have occurred. Contemporary LVAD are associated with improved hemocompatibility, lower rates of pump thrombosis, stroke, and device-related complications, as well as enhanced overall survival compared with earlier-generation devices. Furthermore, this temporal distribution contributed to an imbalance in follow-up duration with patients in the interval LSG group having a longer follow-up period. This discrepancy may, at least in part, account for the higher observed rates of transplantation in that group, simply due to a longer time at risk. Although this represents, to our knowledge, the largest cohort reported to date examining outcomes of LSG in the setting of LVAD support, the overall sample size remains relatively small, limiting the power to detect statistically significant differences for some outcomes. Selection bias is also an important consideration, as patients selected for simultaneous LVAD/LSG may have differed systematically from those undergoing interval LSG in ways not fully captured in the dataset, particularly given non-randomized retrospective design and the relatively small interval LSG comparator group. Additionally, the limited number of events restricted our ability to perform robust multivariable adjustment, and residual confounding is therefore likely. Accordingly, these findings should be considered hypothesis-generating and should not be interpreted as definitive evidence of superiority or equivalence between treatment strategies.
In summary, this single-center retrospective cohort study found that simultaneous LVAD/LSG was associated with LSG–related outcomes comparable to those observed with an interval approach, without an apparent increase in LSG-related complications. Simultaneous LVAD/LSG may also offer potential advantages, including reduced transfusion requirements and a shorter time to heart transplantation in appropriately selected patients. Although the higher incidence of AKI in the simultaneous group warrants further investigation, these findings suggest that simultaneous LVAD/LSG may represent a feasible strategy to optimize transplant candidacy in patients with obesity and ESHF. However, given the study’s non-randomized design, small sample size, and potential temporal and selection-related confounding, the results should be considered hypothesis-generating. Larger multicenter prospective studies are needed to better define the safety, efficacy, optimal patient selection, and long-term transplant-related outcomes associated with simultaneous versus interval LVAD/LSG strategies.
Author Contributions
O.O. Led study conception and design; coordinated data collection and integrity checks; assisted in data analysis and interpretation, drafted portions of the manuscript; and approved the final version.S.N. Contributed to study design and patient selection criteria; assisted with data extraction, outcome verification and analysis interpretation; contributed to interpretation of surgical and perioperative findings; drafted and critically revised the manuscript; incorporated revisions from all coauthors and approved the final version.L.C.Assisted in generating study design; participated in data acquisition and quality control; assisted with analytic interpretation of postoperative outcomes; provided critical manuscript revisions for accuracy and clarity; and approved the final version.M.F.Contributed to dataset development, design and clinical outcome review; assisted in interpretation of bariatric surgery–related events; drafted and provided critical revisions to the manuscript; and approved the final version.S.S.Provided senior bariatric surgery expertise; guided study design, bariatric methodology, and interpretation of sleeve-gastrectomy–related complications; contributed substantive intellectual revisions; and approved the final manuscript.P.W.Provided bariatric surgical expertise for study design; contributed to interpretation of operative risk, perioperative management, and bariatric-associated outcomes; drafted and critically revised manuscript content; and approved the final version.M.J.Provided cardiology and advanced heart-failure expertise during study design; contributed to analysis and interpretation of transplant-related outcomes; drafted and critically revised the manuscript for clinical accuracy; and approved the final version.M.P.Participated in LVAD surgical management and interpretation of intraoperative outcomes; contributed to design study and safety protocol; contributed to data interpretation; revised and edited the manuscript for technical accuracy; and approved the final version.I.S.Assisted in evaluation of LVAD device selection and cardiac outcomes; contributed to interpretation of device-related complications; assisted in study design; critically reviewed and revised the manuscript; and approved the final version.J.P.Contributed to cardiac assessment of heart-failure status, assisted in generating study design for cardiac patients; interpretation of postoperative LVAD outcomes, and transplant trajectory; drafted and provided key revisions to the manuscript; and approved the final version.K.D.Provided critical care expertise in managing complex perioperative heart-failure and LVAD physiology; contributed to interpretation of AKI and hemodynamic complications; assisted in safety protocol of study design; revised the manuscript; and approved the final version.S.N.Provided expertise in advanced heart-failure therapy and mechanical circulatory support; assisted in study design and interpretation of LVAD-related complications; contributed significant manuscript revisions; and approved the final version.B.A.Contributed to perioperative intensive-care management interpretation, including ventilatory, renal, and hemodynamic outcomes; provided support for study design safety; critically revised and edited the manuscript; and approved the final version.B.K.Provided senior cardiology expertise; contributed to interpretation of LVAD hemodynamics, device durability, and transplant candidacy; offered substantial intellectual revisions; generated study design from cardiac perspective; and approved the final manuscript.I.G.Provided major intellectual contribution to study conception, LVAD operative methodology, and interpretation of cardiovascular outcomes; contributed to analysis; critically revised and edited the manuscript; and approved the final version.K.B.Participated in study conception, design, and methodology; revised data analysis and interpretation from bariatric surgery perspective; provided major intellectual revisions ensuring scientific integrity; revised and edited manuscript; approved the final version of final version.
Funding
No external funding source was used during this study.
Data Availability
Data may be provided upon reasonable request.
Declarations
Ethics Statement
This study, including consent and procedure, was conducted in accordance with the ethical standards of The University of Texas Health Science Center at Houston and approval for this research was obtained from its Institutional Review Board. All participants were free to withdraw at any time without any consequence. All data collected was kept confidential and anonymized prior to analysis to ensure privacy and data protection.
Competing interests
The authors declare no competing interests.
Footnotes
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Contributor Information
Oscar Olavarria, Email: oscar.a.olavarria@uth.tmc.edu.
Syed Naqvi, Email: syed.h.naqvi@uth.tmc.edu.
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Associated Data
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Data Availability Statement
Data may be provided upon reasonable request.