Ventricular assist device using a thoracotomy-based implant technique: Multi-Center Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy (HM3 SWIFT).

OBJECTIVES: The HeartMate 3 (Abbott) left ventricular assist device provides substantial improvement in long-term morbidity and mortality in patients with advanced heart failure. The Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study compares thoracotomy-based implantation clinical outcomes with standard median sternotomy. METHODS: We conducted a prospective, multicenter, single-arm study in patients eligible for HeartMate 3 implantation with thoracotomy-based surgical technique (bilateral thoracotomy or partial upper sternotomy with left thoracotomy). The composite primary end point was survival free of disabling stroke (modified Rankin score >3), or reoperation to remove or replace a malfunctioning device, or conversion to median sternotomy at 6-months postimplant (elective transplants were treated as a success). The primary end point (noninferiority, -15% margin) was assessed with >90% power compared with a propensity score-matched cohort (ratio 1:2) derived from the Multi-Center Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 continued access protocol. RESULTS: The study enrolled 102 patients between December 2020 and July 2022 in the thoracotomy-based arm at 23 North American centers. Follow-up concluded in December 2022. In the Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study group, noninferiority criteria was met (absolute between-group difference, -1.2%; Farrington Manning lower 1-sided 95% CI, -9.3%; P < .0025) and event-free survival was not different (85.0% vs 86.2%; hazard ratio, 1.01; 95% CI, 0.58-2.10). Length of stay with thoracotomy-based implant was longer (median, 20 vs 17 days; P = .03). No differences were observed for blood product utilization, adverse events (including right heart failure), functional status, and quality of life between cohorts. CONCLUSIONS: Thoracotomy-based implantation of the HeartMate 3 left ventricular assist device is noninferior to implantation via standard full sternotomy. This study supports thoracotomy-based implantation as an additional standard for surgical implantation of the HeartMate 3 left ventricular assist device.

Less Invasive Left Ventricular Assist Device Implantation Is Safe and Feasible in Patients With Smaller Body Surface Area.

OBJECTIVE: Smaller body surface area (BSA) frequently precludes patients from left ventricular assist device (LVAD) therapy. We sought to investigate the clinical outcomes in patients with small BSA undergoing less invasive LVAD implantation. METHODS: We conducted a retrospective review of 216 patients implanted with HeartMate 3 LVAD (Abbott, Chicago, IL) via less invasive surgery at our institution. Patients were dichotomized based on their preimplant BSA for comparison between small BSA (≤1.8 m2) and normal/large BSA (>1.8 m2). We analyzed patient perioperative characteristics and outcomes. RESULTS: In our study, small BSA was found in 32 patients (14.8%), while 184 patients (85.2%) had normal/large BSA. Women were more prevalent in the small BSA group (50.0% vs 13.0%, P < 0.001). Preoperative and intraoperative data showed comparable results. Major complications and hospital length of stay did not differ by BSA group. Patients with smaller BSA had significantly decreased pump parameters at discharge, including LVAD flow (4.11 ± 0.49 vs 4.60 ± 0.54 L/min, P < 0.001) and pump speed (5,200 vs 5,400 rpm, P < 0.001). Survival to discharge and within 6 months after implantation were similar between the groups. CONCLUSIONS: Our study results suggest that less invasive HeartMate 3 implantation can be safely performed and demonstrates equivalent outcomes in patients with smaller body habitus. Randomized trials are required to confirm our data.

Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial.

BACKGROUND: The use of a Left Ventricular Assist Device (LVAD) in patients with advanced heart failure refractory to optimal medical management has progressed steadily over the past two decades. Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular tachyarrhythmia (VTA). We hypothesize that a novel prophylactic intra-operative VTA ablation protocol at the time of LVAD implantation may reduce the recurrent VTA and adverse events postimplant. METHODS: We designed a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA in the previous 5 years. Enrolled patients will be randomized in a 1:1 fashion to intra-operative VTA ablation (n = 50) versus conventional medical management (n = 50) with LVAD implant. Arrhythmia outcomes data will be captured by an implantable cardioverter defibrillator (ICD) to monitor VTA events, with a uniform ICD programming protocol. Patients will be followed prospectively over a mean of 18 months (with a minimum of 9 months) after LVAD implantation to evaluate recurrent VTA, adverse events, and procedural outcomes. Secondary endpoints include right heart function/hemodynamics, healthcare utilization, and quality of life. CONCLUSION: The primary aim of this first-ever randomized trial is to assess the efficacy of intra-operative ablation during LVAD surgery in reducing VTA recurrence and improving clinical outcomes for patients with a history of VTA.

Flap Coverage of Infected Ventricular Assist Devices Influences Patient Outcomes.

BACKGROUND: The use of left ventricular assist devices (LVADs) for patients with end-stage cardiac failure awaiting heart transplantation has become increasingly common. However, ventricular assist device-related infections remain a major problem complicating their long-term use. Poor data exist to determine how to manage these infections after operative debridement. METHODS: Patients who underwent insertion of a ventricular assist device and had a subsequent readmission for LVAD infection at the University of Rochester Medical Center from 2012 to 2022 were identified through accessing the medical records archives of the hospital. Patients were followed retrospectively for an average of 3.2 years. Patient demographics, preoperative diagnosis/disease state, type of ventricular assist device inserted, postoperative day of ventricular assist device infection onset, infectious organism identified at initial washout, infectious organism identified at time of definitive device coverage, timing of coverage procedure after the initial washout for infection, type of flap used for coverage, 90-day complications after definitive coverage, and lifetime return to operating room for infection were reviewed. Comparison analysis with a χ 2 test was used to analyze outcomes. RESULTS: Of 568 patients admitted with an LVAD-related infection 117 underwent operative debridement. Of these, 34 underwent primary closure, 31 underwent closure with secondary intention (negative pressure wound therapy with split thickness skin grafting), and 52 were closed with a flap (pectoralis, omental, latissimus, or vertical rectus abdominus musculocutaneous flap). There was a statistically significant higher incidence of return to the operating room (RTOR) for infection over a lifetime with primary closure compared with secondary intention and flap reconstruction ( P = 0.01, 0.02), but no difference in 90-day complications ( P = 0.76, P = 0.58). Eighty-three patients had a positive culture upon definitive coverage with 24 having a postsurgical complication, 15 of which required lifetime RTOR for infection. Thirty four were closed with negative cultures with 9 having a complication and 4 requiring RTOR for infection. This was not statistically significant for complications or RTOR ( P = 0.79, 0.40). Culture data were further substratified into bacterial cultures (n = 73) versus fungal cultures (n = 10), and there was no statistically significant difference between these compared with complications or RTOR ( P = 0.40, 0.39). CONCLUSIONS: Coverage of infected LVADs with locoregional flaps or allowing to granulate using wound vac therapy has a decreased lifetime RTOR for future infections for these patients without increase in 90-day complications. Timing of RTOR should not be impacted by positive cultures provided there is healthy granulation tissue in the wound.

The Society of Thoracic Surgeons Intermacs 2022 Annual Report: Focus on the 2018 Heart Transplant Allocation System.

The 13th annual report from The Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) highlights outcomes for 27,314 patients receiving continuous-flow durable left ventricular assist devices (LVAD) during the last decade (2012-2021). In 2021, 2464 primary LVADs were implanted, representing a 23.5% reduction in the annual volume compared with peak implantation in 2019 and an ongoing trend from the prior year. This decline is likely a reflection of the untoward effects of the coronavirus disease 2019 pandemic and the change in the United States heart transplant allocation system in 2018. The last several years have been characterized by a shift in device indication and type, with 81.1% of patients now implanted as destination therapy and 92.7% receiving an LVAD with full magnetic levitation in 2021. However, despite an older, more ill population being increasingly supported preimplant with temporary circulatory devices in the recent (2017-2021) vs prior (2012-2016) eras, the 1- and 5-year survival continues to improve, at 83.0% and 51.9%, respectively. The adverse events profile has also improved, with a significant reduction in stroke, gastrointestinal bleeding, and hospital readmissions. Finally, we examined the impact of the change in the heart transplant allocation system in 2018 on LVAD candidacy, implant strategy, and outcomes. In the competing-outcomes analysis, the proportion of transplant-eligible patients receiving a transplant has declined from 56.5% to 46.0% at 3 years, whereas the proportion remaining alive with ongoing support has improved from 24.1% to 38.1% at 3 years, underscoring the durability of the currently available technology.

Left atrial appendage exclusion with less invasive left ventricular assist device implantation.

OBJECTIVES: The objective of this single-center, pilot, prospective, and historical control study is to evaluate safety and feasibility outcomes associated with left atrial appendage exclusion (LAAE) concomitant with left ventricular assist device (LVAD) implantation via less invasive surgery (LIS) as a stroke prevention strategy. METHODS: A predefined number of 30 eligible subjects scheduled for LIS LVAD with LAAE were enrolled in the prospective arm between January 2020 and February 2021. Eligible retrospective LIS LVAD patients without LAAE were propensity-matched in a 1:1 ratio with the prospective arm subjects. The primary study objectives were to evaluate the safety, feasibility, and efficacy of the LAAE concomitant with LIS LVAD. RESULTS: Preoperative characteristics of patients in the Non-LAAE and LAAE groups were similar. LAAE was successfully excluded in all prospective patients (100%). Primary safety endpoints of chest tube output within the first 24 postoperative hours, Reoperation for bleeding within 48 h, and index hospitalization mortality demonstrated comparable safety of LAAE versus Non-LAAE with LIS LVAD. Cox proportional hazard regression demonstrated that LAAE with LIS LVAD was associated with 37% and 49% reduction in the risk of stroke and disabling stroke, respectively (p > .05). CONCLUSION: Results from our pilot study demonstrated the safety and feasibility of LAAE concomitant with LIS LVAD as a stroke prevention strategy. This is the first prospective study describing LAAE performed concomitantly to less invasive LVAD implantation. The efficacy of LAAE in long-term stroke prevention needs to be confirmed in future prospective randomized clinical trials.

Novel Automated Suturing Technology for Minimally Invasive Mitral Chord Implantation: A Preclinical Evaluation Study.

OBJECTIVE: This study evaluated the ergonomics and time requirements of using a novel automated suturing and titanium fastener deployment technology for chordal replacement in human heart specimens in open and minimally invasive cardiac surgery (MICS) simulators. METHODS: Five cardiac surgeons used novel, manually powered expanded polytetrafluoroethylene (ePTFE) suturing devices to automate suture placement between mitral leaflets and papillary muscles in explanted cadaver hearts, along with customized titanium fastener delivery devices to secure suture and trim suture tails. This mitral chordal replacement test was conducted using surgical models simulating open and MICS mitral repair access. The study was approved by the institutional ethical board. RESULTS: After a brief introduction to this technique using plastic models, study surgeons performed 48 chordal replacements in human mitral valves, placing 18 in an open model and 30 in a right minithoracotomy model. The time range to complete a single chordal replacement was between 55 s and 8 min, with an overall mean duration of 3.6 ± 1.5 min. No difference in duration of implantation was recorded for the MICS and open sternotomy simulators used. Good control of suture delivery was reported in 95.8% (n = 46) of leaflet aspect of the sutures and in 100% (N = 48) of papillary muscle sutures. CONCLUSIONS: Automated mitral chordal ePTFE suturing simulated through open and MICS access demonstrated quality handling and accurate placement of sutures in human heart specimens. A clinical trial using this technology is currently ongoing. This innovation may present an important advance facilitating enhanced minimally invasive mitral valve repair.

Association Between the COVID-19 Pandemic and Insurance-Based Disparities in Mortality After Major Surgery Among US Adults.

Importance: The COVID-19 pandemic caused significant disruptions in surgical care. Whether these disruptions disproportionately impacted economically disadvantaged individuals is unknown. Objective: To evaluate the association between the COVID-19 pandemic and mortality after major surgery among patients with Medicaid insurance or without insurance compared with patients with commercial insurance. Design, Setting, and Participants: This cross-sectional study used data from the Vizient Clinical Database for patients who underwent major surgery at hospitals in the US between January 1, 2018, and May 31, 2020. Exposures: The hospital proportion of patients with COVID-19 during the first wave of COVID-19 cases between March 1 and May 31, 2020, stratified as low (≤5.0%), medium (5.1%-10.0%), high (10.1%-25.0%), and very high (>25.0%). Main Outcomes and Measures: The main outcome was inpatient mortality. The association between mortality after surgery and payer status as a function of the proportion of hospitalized patients with COVID-19 was evaluated with a quasi-experimental triple-difference approach using logistic regression. Results: Among 2 950 147 adults undergoing inpatient surgery (1 550 752 female [52.6%]) at 677 hospitals, the primary payer was Medicare (1 427 791 [48.4%]), followed by commercial insurance (1 000 068 [33.9%]), Medicaid (321 600 [10.9%]), other payer (140 959 [4.8%]), and no insurance (59 729 [2.0%]). Mortality rates increased more for patients undergoing surgery during the first wave of the pandemic in hospitals with a high COVID-19 burden (adjusted odds ratio [AOR], 1.13; 95% CI, 1.03-1.24; P = .01) and a very high COVID-19 burden (AOR, 1.38; 95% CI, 1.24-1.53; P < .001) compared with patients in hospitals with a low COVID-19 burden. Overall, patients with Medicaid had 29% higher odds of death (AOR, 1.29; 95% CI, 1.22-1.36; P < .001) and patients without insurance had 75% higher odds of death (AOR, 1.75; 95% CI, 1.55-1.98; P < .001) compared with patients with commercial insurance. However, mortality rates for surgical patients with Medicaid insurance (AOR, 1.03; 95% CI, 0.82-1.30; P = .79) or without insurance (AOR, 0.85; 95% CI, 0.47-1.54; P = .60) did not increase more than for patients with commercial insurance in hospitals with a high COVID-19 burden compared with hospitals with a low COVID-19 burden. These findings were similar in hospitals with very high COVID-19 burdens. Conclusions and Relevance: In this cross-sectional study, the first wave of the COVID-19 pandemic was associated with a higher risk of mortality after surgery in hospitals with more than 25.0% of patients with COVID-19. However, the pandemic was not associated with greater increases in mortality among patients with no insurance or patients with Medicaid compared with patients with commercial insurance in hospitals with a very high COVID-19 burden.

Impact of surgical approach for left ventricular assist device implantation on postoperative invasive hemodynamics and right ventricular failure.

BACKGROUND: Right ventricular failure (RVF) remains one of the major causes of morbidity and mortality after left ventricular assist device (LVAD) implantation. We sought to compare immediate postoperative invasive hemodynamics and the risk of RVF following two different surgical approaches: less invasive surgery (LIS) versus full sternotomy (FS). METHODS: The study population comprised all 231 patients who underwent implantation of a HeartMate 3 (Abbott) LVAD at our institution from 2015 to 2020, utilizing an LIS (n = 161; 70%) versus FS (n = 70; 30%) surgical approach. Outcomes included postoperative invasive hemodynamic parameters, vasoactive-inotropic score (VIS), RVF during index hospitalization, and 6-month mortality. RESULTS: Baseline clinical characteristics of the two groups were similar. Multivariate analysis showed that LIS, compared with FS, was associated with the improved cardiac index (CI) at the sixth postoperative hour (p = .036) and similar CI at 24 h, maintained by lower VIS at both timepoints (p = .002). The LIS versus FS approach was also associated with a three-fold lower incidence of in-hospital severe RVF (8.7% vs. 28.6%, p < .001) and need for RVAD support (5.0% vs. 17.1%, p = .003), and with 68% reduction in the risk of 6-month mortality after LVAD implantation (Hazard ratio, 0.32; CI, 0.13-0.78; p = .012). CONCLUSION: Our findings suggest that LIS, compared with FS, is associated with a more favorable hemodynamic profile, as indicated by similar hemodynamic parameters maintained by lower vasoactive-inotropic support during the acute postoperative period. These findings were followed by a reduction in the risk of severe RVF and 6-month mortality in the LIS group.

Anesthetic Considerations for Minimally Invasive, Off-Pump, HeartMate III Implantation.

OBJECTIVE: The authors developed and utilized an anesthetic protocol for the management of an off-pump approach for minimally invasive Heartmate III (HM3) implantation. Their goal was to determine if this method was safe and feasible for patients with in-situ mechanical support. DESIGN: The authors performed a retrospective study of consecutive patients undergoing off-pump HM3 implantation via bilateral minithoracotomies. SETTING: This was a single-institution study at the University of Rochester Medical Center, using the same cardiac anesthesiologist and cardiac surgeon pair. PARTICIPANTS: The authors studied 8 consecutive patients undergoing off-pump HM3 implantation from June 2019 to July 2020. INTERVENTIONS: The authors developed an anesthetic management protocol for off-pump HM3 implantation via bilateral minithoracotomies. MEASUREMENTS AND MAIN RESULTS: As a result, the authors evaluated 88% of men with a mean age of 55.0 ±13.0 years. The median time to extubation was 19.7 hours, with a median intensive care unit length of stay of 6.5 days. Fifty percent of patients required blood transfusions during the first 24 hours after surgery (postoperative), and 63% of patients were free from all postoperative complications. No patients required a right ventricular assist device. The mean hospital stay was 26.3 ± 11.3 days, with an 88% survival to discharge. CONCLUSION: In this single-center study, the authors have described the anesthetic consideration for the implantation of the HM3 left ventricular assist device using a complete sternal-sparing technique without the use of cardiopulmonary bypass. Their results have shown, in a case series of 8 patients, that this is a safe and feasible alternative to traditional techniques in patients with existing mechanical support.

Patient-Reported Outcomes Measurement Information System (PROMIS) in Left Ventricular Assist Devices.

BACKGROUND: Appropriate collection of quality of life measurements for left ventricular assist device (LVAD) patients is challenging. Patient-Reported Outcomes Measurement Information System (PROMIS) is a popular tool that has been validated across multiple disciplines, but its applicability to the LVAD population remains unknown. METHODS: This single-center, retrospective review included LVAD patients who completed a PROMIS assessment and Kansas City Cardiomyopathy Questionnaire (KCCQ-12) survey at clinical encounters postoperatively. Patients completed computer adaptive PROMIS assessments for physical function, pain interference, and depression. All PROMIS domains are designed to follow a normal distribution (mean T-score 50, SD 10) in the general population. Assessments were aggregated over time and correlation between the KCCQ-12 summary score and each PROMIS domain was assessed individually. RESULTS: A total of 178 LVAD patients were included in the study. The median time between LVAD implantation and PRO collection was 16.5 [interquartile range, 7.9-37.8] months. Patients typically had worse physical function (T-score 38.8 [33.6-44.2]) but comparable pain (51.1 [38.7-59.2]) and depression (49.9 [41.7-57.5]) as the general population. The KCCQ-12 was more strongly correlated to PROMIS physical function (Spearman's ρ = 0.746) than pain (ρ = -0.539) or depression (ρ = -0.591). CONCLUSIONS: PROMIS provides a robust quality of life data collection system that can be implemented in a clinical setting without imposing a significant burden. Using this more holistic system may allow for better patient-centered care in order to address quality of life limitations imposed by LVAD support that are not directly related to heart failure symptoms.

Long-term survival on LVAD support: Device complications and end-organ dysfunction limit long-term success.

BACKGROUND: Preoperative variables can predict short term left ventricular assist device (LVAD) survival, but predictors of extended survival remain insufficiently characterized. METHOD: Patients undergoing LVAD implant (2012-2018) in the Intermacs registry were grouped according to time on support: short-term (<1 year, n = 7,483), mid-term (MT, 1-3 years, n = 5,976) and long-term (LT, ≥3 years, n = 3,015). Landmarked hazard analyses (adjusted hazard ratio, HR) were performed to identify correlates of survival after 1 and 3 years of support. RESULTS: After surviving 1 year of support, additional LVAD survival was less likely in older (HR 1.15 per decade), Caucasian (HR 1.22) and unmarried (HR 1.16) patients (p < 0.05). After 3 years of support, only 3 preoperative characteristics (age, race, and history of bypass surgery, p < 0.05) correlated with extended survival. Postoperative events most negatively influenced achieving LT survival. In those alive at 1 year or 3 years, the occurrence of postoperative renal (creatinine HR MT = 1.09; LT HR = 1.10 per mg/dl) and hepatic dysfunction (AST HR MT = 1.29; LT HR = 1.34 per 100 IU), stroke (MT HR = 1.24; LT HR = 1.42), infection (MT HR = 1.13; LT HR = 1.10), and/or device malfunction (MT HR = 1.22; LT HR = 1.46) reduced extended survival (all p ≤ 0.03). CONCLUSIONS: Success with LVAD therapy hinges on achieving long term survival in more recipients. After 1 year, extended survival is heavily constrained by the occurrence of adverse events and postoperative end-organ dysfunction. The growth of destination therapy intent mandates that future LVAD studies be designed with follow up sufficient for capturing outcomes beyond 24 months.

Management of Heparin-Induced Thrombocytopenia Using Plasmapharesis in Patients Undergoing HeartMate 3 Left Ventricular Assist Device.

Heparin-induced thrombocytopenia (HIT) type-2 is a rare, but life-threatening complication that presents a unique challenge in patients undergoing cardiac surgery. Patients that require cardiac surgery with HIT present a dilemma between intraoperative anticoagulation, perioperative bleeding risk, and perioperative thrombotic events. We describe a case series of four patients who developed HIT in their hospital course before HeartMate 3 (HM3) left ventricular assist device implantation. Following a multidisciplinary approach, all patients did well intraoperatively with an approach of preoperative plasmapheresis, intraoperative unfractionated heparin (UFH), and postoperative conversion to bivalirudin with a bridge to warfarin. However, two patients had postoperative bleeding complications on bivalirudin. This case series details the therapeutic challenges encountered for HM3 implantation in patients with HIT and offers a therapeutic alternative to intraoperative bivalirudin in the effort to decrease perioperative complications in this challenging patient population.

Using machine learning to improve survival prediction after heart transplantation.

BACKGROUND: This study investigates the use of modern machine learning (ML) techniques to improve prediction of survival after orthotopic heart transplantation (OHT). METHODS: Retrospective study of adult patients undergoing primary, isolated OHT between 2000 and 2019 as identified in the United Network for Organ Sharing (UNOS) registry. The primary outcome was 1-year post-transplant survival. Patients were randomly divided into training (80%) and validation (20%) sets. Dimensionality reduction and data re-sampling were employed during training. Multiple machine learning algorithms were combined into a final ensemble ML model. The discriminatory capability was assessed using the area under receiver-operating-characteristic curve (AUROC), net reclassification index (NRI), and decision curve analysis (DCA). RESULTS: A total of 33,657 OHT patients were evaluated. One-year mortality was 11% (n = 3738). In the validation cohort, the AUROC of singular logistic regression was 0.649 (95% CI, 0.628-0.670) compared to 0.691 (95% CI, 0.671-0.711) with random forest, 0.691 (95% CI, 0.671-0.712) with deep neural network, and 0.653 (95% CI, 0.632-0.674) with Adaboost. A final ensemble ML model was created that demonstrated the greatest improvement in AUROC: 0.764 (95% CI, 0.745-0.782) (p < .001). The ensemble ML model improved predictive performance by 72.9% ±3.8% (p < .001) as assessed by NRI compared to logistic regression. DCA showed the final ensemble method improved risk prediction across the entire spectrum of predicted risk as compared to all other models (p < .001). CONCLUSIONS: Modern ML techniques can improve risk prediction in OHT compared to traditional approaches. This may have important implications in patient selection, programmatic evaluation, allocation policy, and patient counseling and prognostication.

Management of Substance Use Disorders in a Patient With Left Ventricular Assist Device.

We present a case of common challenges in assessment and treatment of substance use disorders in patients with advanced heart failure requiring left ventricular assist device (LVAD). Top experts in the field of consultation-liaison psychiatry, cardiology, and cardiac surgery provide guidance for this commonly encountered clinical case based on their experience and review of the available literature. Key teaching topics include the role of LVAD in heart failure management, the impact of substance use disorder on heart failure and LVAD patient outcomes, and recommendations for assessment and management of substance use disorder in a patient with LVAD. Specifically, we highlight the challenges of assessing for substance use disorder in LVAD candidates and the limited literature available to guide treatment in this challenging patient population.

Study results suggest less invasive HeartMate 3 implantation is a safe and effective approach for obese patients.

BACKGROUND: Historically, obesity was considered a relative contraindication to left ventricular assist device (LVAD) implantation with less invasive surgery (LIS). The present study aimed to compare the outcomes of obese patients who underwent LVAD implantation through LIS with those who received full sternotomy (FS) implantation. METHODS: We retrospectively reviewed all patients implanted with HeartMate 3 LVAD in our institution between September 2015 and June 2020. Obese patients (BMI ≥ 30 kg/m2) were included and dichotomized based on surgical approach into the FS or LIS cohort. RESULTS: Of 231 implanted patients, 107 (46%) were obese and included in the study. FS was performed in 26 (24%) patients and LIS approach in 81 (76%) patients. Preoperative patient characteristics were similar between the cohorts. Postoperatively, patients in LIS cohort had less bleeding (p = 0.029), fewer transfusions (p = 0.042), shorter duration of inotropic support (p = 0.049), and decreased incidence of severe RV failure (11.1% vs 30.8%, p = 0.028). Survival to discharge for the obese population was 87.5% overall and did not differ based on an approach (91.4% LIS vs 76.9% FS, p = 0.079). More LIS patients were discharged home (60.0% vs 82.4%, p = 0.041) rather than to rehabilitation center. CONCLUSION: Our results showed that the LIS approach in obese patients is associated with fewer postoperative complications and a trend towards better short-term survival. These results suggest that less invasive LVAD implantation is a safe and effective approach for obese patients. Future prospective randomized trials are required to substantiate these results.

Enhanced Recovery After Surgery in Patients Implanted with Left Ventricular Assist Device.

INTRODUCTION: We sought to develop and implement a comprehensive enhanced recovery after surgery (ERAS) protocol for patients implanted with a left ventricular assist device (LVAD). METHODS AND RESULTS: In this article, we describe our approach to the development and phased implementation of the protocol. Additionally, we reviewed prospectively collected data for patients who underwent LVAD implantation at our institution from February 2019 to August 2020. To compare early outcomes in our patients before and after protocol implementation, we dichotomized patients into two 6-month cohorts (the pre-ERAS and ERAS cohorts) separated from each other by 6 months to allow for staff adoption of the protocol. Of the 115 LVAD implants, 38 patients were implanted in the pre-ERAS period and 46 patients in the ERAS period. Preoperatively, the patients` characteristics were similar between the cohorts. Postoperatively, we observed a decrease in bleeding (chest tube output of 1006 vs 647.5 mL, P < .001) and blood transfusions (fresh frozen plasma 31.6% vs 6.7%, P = .04; platelets 42.1% vs 8.7%, P = .001). Opioid prescription at discharge were 5-fold lower with the ERAS approach (P < .01). Furthermore, the number of patients discharged to a rehabilitation facility decreased significantly (20.0% vs 2.4%, P = .02). The index hospitalization length of stay and survival were similar between the groups. CONCLUSIONS: ERAS for patients undergoing LVAD implantation is a novel, evidence-based, interdisciplinary approach to care with multiple potential benefits. In this article, we describe the details of the protocol and early positive changes in clinical outcomes. Further studies are needed to evaluate benefits of an ERAS protocol in an LVAD population.Lay Summary: Enhanced recovery after surgery (ERAS) is the implementation of standardized clinical pathways that ensures the use of best practices and decreased variation in perioperative care. Multidisciplinary teams work together on ERAS, thereby enhancing communication among health care silos. ERAS has been used for more than 30 years by other surgical services and has been shown to lead to a decreased length of stay, fewer complications, lower mortality, fewer readmissions, greater job satisfaction, and lower costs. Our goal was to translate these benefits to the perioperative care of complex patients with a left ventricular assist device. Early results suggest that this goal is possible; we have observed a decrease in transfusions, discharge on opioids, and discharge to a rehabilitation facility.

Smoking and the Risk of Stroke in Patients with a Left Ventricular Assist device.

There are limited data on the association of smoking with the risk of stroke following left ventricular assist device (LVAD) implantation. We designed this study to analyze the impact of smoking status at the time of LVAD implantation on stroke. We hypothesized that current smokers are at increased risk of stroke when compared with patients who were former or never smokers. The study population comprised of 369 patients in the University of Rochester Medical Center LVAD database, implanted with an LVAD between 2008 and 2018. Patients were stratified as current smoker (smoking within 30 days before LVAD implantation), former smoker, and never smoker. Stroke was defined as a transient ischemic attack or cerebrovascular accident (hemorrhagic or ischemic). There were 45 current smokers, 198 former smokers, and 125 never smokers. Current smokers were younger (mean age 50 ± 11 years), as compared with former (58 ± 12 years) and never smokers (56 ± 13 years) p < 0.001. At 2 years following LVAD implantation, the cumulative incidence of stroke was significantly higher among current smokers (39%) as compared with former and never smokers (16% and 15%, respectively; p = 0.022 for the overall difference during follow-up). In a multivariate model adjusted for significant clinical variables, current smoking was associated with a significant 88% (p = 0.018) higher risk of stroke when compared with all noncurrent smokers. In conclusion, our data suggest that LVAD candidates who are current smokers experience a significantly higher risk of stroke following device implantation.

Complete sternal-sparing left ventricular assist device implantation is associated with improved postoperative mobility.

Left ventricular assist device (LVAD) implantation via a complete sternal-sparing (CSS) technique is gaining interest due to several potential benefits. We hypothesized that the CSS approach for HeartMate 3 (HM3) LVAD implantation improves postoperative mobility and physical independence compared to full sternotomy (FS). We retrospectively reviewed patients who were implanted with a commercial HM3 at our institution from September 2017 to August 2018. The Activity Measure for Post-Acute Care short forms and Functional Independence Measure scores were used to assess the patient's physical limitations postoperatively. A total of 43 patients were included in the study: 27 (63%) CSS patients and 16 (37%) FS patients. At postoperative day 3, the CSS cohort demonstrated improved mobility based on Activity Measure for Post-Acute Care scores compared to the FS group; 40% of the CSS cohort versus 67% of the FS cohort remained 100% impaired. The CSS cohort also demonstrated greater postoperative independence in the Functional Independence Measure sit-to-stand metric with 78% of the CSS cohort achieving modified or complete independence by postoperative day 15 compared to only 21% of the FS patients. These early data suggest that the CSS approach for HM3 LVAD implantation improves postoperative mobility and functional independence compared to FS.

Long-term renal function after venoarterial extracorporeal membrane oxygenation.

BACKGROUND: The utilization of venoarterial extracorporeal membrane oxygenation (VA-ECMO) as a life-supporting therapy has increased exponentially over the last decade. As more patients receive and survive ECMO, there are a number of unanswered clinical questions about their long-term prognosis and organ function including the need for long-term dialysis. METHODS: We aimed to utilize over 208 patient-years of follow-up data from our large institutional cohort of VA-ECMO patients to determine the incidence of requiring VA-ECMO support on the need for renal replacement therapy after discharge (LT-dialysis). This retrospective review included all adult VA-ECMO patients at our institution from January 2014 to October 2018 (N = 283). RESULTS: Out of the 99 (35%) survivors, 88 (89%) did not require LT-dialysis of any duration after discharge from the index hospitalization. Patients who required VA-ECMO for decompensated cardiogenic shock were more likely to need LT-dialysis (p = .034), and those who required renal replacement therapy during VA-ECMO (N = 27) also had a higher incidence of LT-dialysis (33%). CONCLUSION: Overall, these data suggest there is a low incidence of long-term dialysis dependence among survivors of VA-ECMO support. Worries about the potential long-term detrimental effect of VA-ECMO should not preclude patients from receiving this life-saving support.