Gastrointestinal bleeding following Heartmate 3 left ventricular assist device implantation: The Michigan Bleeding Risk Model.

BACKGROUND: Gastrointestinal bleeding (GIB) results in frequent hospitalizations and impairs quality of life in durable left ventricular assist device (LVAD) recipients. Anticipation of these events before implantation could have important implications for patient selection and management. METHODS: The study population included all adult HeartMate 3 (HM3) primary LVAD recipients enrolled in the STS Intermacs registry from January 2017 to December 2020. Using multivariable modeling methodologies, we investigated the relationships between preimplantation characteristics and postimplant bleeding, bleeding and death, and additional bleeding episodes on subsequent bleeding episodes and created a risk score to predict the likelihood of post-LVAD GIB based solely on preimplantation factors. RESULTS: Of 6,425 patients who received an HM3 LVAD, 1,010 (15.7%) patients experienced GIB. Thirteen preimplantation factors were independent predictors of post-LVAD GIB. A risk score was created from these factors and calculated for each patient. By 3 years postimplant, GIB occurred in 11%, 26%, and 43% of low-, medium- and high-risk patients, respectively. Experiencing 1 post-LVAD GIB event was associated with an increased risk for further GIB events, with 33.9% of patients experiencing at least 1 recurrence. While post-LVAD GIB was associated with mortality, there was no relationship between number of GIB events and death. CONCLUSIONS: The Michigan Bleeding Risk Model is a simple tool, which facilitates the prediction of post-LVAD GIB in HM3 recipients using 13 preimplant variables. The implementation of this tool may help in the risk stratification process and may have therapeutic and clinical implications in HM3 LVAD recipients.

Pulmonary Rehabilitation for Adults with Chronic Respiratory Disease: An Official American Thoracic Society Clinical Practice Guideline.

Background: Despite the known benefits of pulmonary rehabilitation (PR) for patients with chronic respiratory disease, this treatment is underused. Evidence-based guidelines should lead to greater knowledge of the proven benefits of PR, highlight the role of PR in evidence-based health care, and in turn foster referrals to and more effective delivery of PR for people with chronic respiratory disease. Methods: The multidisciplinary panel formulated six research questions addressing PR for specific patient groups (chronic obstructive pulmonary disease [COPD], interstitial lung disease, and pulmonary hypertension) and models for PR delivery (telerehabilitation, maintenance PR). Treatment effects were quantified using systematic reviews. The Grading of Recommendations, Assessment, Development and Evaluation approach was used to formulate clinical recommendations. Recommendations: The panel made the following judgments: strong recommendations for PR for adults with stable COPD (moderate-quality evidence) and after hospitalization for COPD exacerbation (moderate-quality evidence), strong recommendation for PR for adults with interstitial lung disease (moderate-quality evidence), conditional recommendation for PR for adults with pulmonary hypertension (low-quality evidence), strong recommendation for offering the choice of center-based PR or telerehabilitation for patients with chronic respiratory disease (moderate-quality evidence), and conditional recommendation for offering either supervised maintenance PR or usual care after initial PR for adults with COPD (low-quality evidence). Conclusions: These guidelines provide the basis for evidence-based delivery of PR for people with chronic respiratory disease.

Periprocedural Complications With Balloon Pulmonary Angioplasty: Analysis of Global Studies.

BACKGROUND: Balloon pulmonary angioplasty (BPA) was introduced as a treatment modality for patients with inoperable, medically refractory chronic thromboembolic pulmonary hypertension decades ago; however, reports of high rates of pulmonary vascular injury have led to considerable refinement in procedural technique. OBJECTIVES: The authors sought to better understand the evolution of BPA procedure-related complications over time. METHODS: The authors conducted a systematic review of original articles published by pulmonary hypertension centers globally and performed a pooled cohort analysis of procedure-related outcomes with BPA. RESULTS: This systematic review identified 26 published articles from 18 countries worldwide from 2013 to 2022. A total of 1,714 patients underwent 7,561 total BPA procedures with an average follow up of 7.3 months. From the first period (2013-2017) to the second period (2018-2022), the cumulative incidence of hemoptysis/vascular injury decreased from 14.1% (474/3,351) to 7.7% (233/3,029) (P < 0.01); lung injury/reperfusion edema decreased from 11.3% (377/3,351) to 1.4% (57/3,943) (P < 0.01); invasive mechanical ventilation decreased from 0.7% (23/3,195) to 0.1% (4/3,062) (P < 0.01); and mortality decreased from 2.0% (13/636) to 0.8% (8/1,071) (P < 0.01). CONCLUSIONS: Procedure-related complications with BPA, including hemoptysis/vascular injury, lung injury/reperfusion edema, mechanical ventilation, and death, were less common in the second period (2018-2022), compared with first period (2013-2017), likely from refinement in patient and lesion selection and procedural technique over time.

Greater geographic sharing and heart transplantation waitlist outcomes following the 2018 heart allocation policy.

BACKGROUND: In 2018, a new heart allocation policy was introduced to reduce variability in access to and outcomes after transplantation, in part, through attempts at broader geographic sharing of donor hearts. We evaluated how this policy affected geographic sharing and waitlist outcomes by donation service area (DSA). METHODS: This retrospective study of the Scientific Registry of Transplant Recipients database included adult patients waitlisted between October 2016 and October 2020, stratified by policy period. Our primary outcomes were mean proportion of imported and exported hearts aggregated by DSA as well as time to transplant. RESULTS: Following the policy change, there was substantial evidence of sharing across DSAs. The mean proportion of imported hearts transplanted by a DSA increased from 32% (95% CI: 27%-36%) to 74% (95% CI: 71%-78%; p < 0.001), and the mean proportion of exported hearts increased from 37% (95% CI: 33%-42%) to 75% (95% CI: 71%-79%; p < 0.001). The mean sharing ratio, defined as the log-transformed ratio of imported to exported hearts per DSA, shifted from 1.15 (95% CI: 0.88-1.42) to 1.02 (95% CI: 0.96-1.07), with a 76% decline in the variance across DSAs. As sharing increased, time to transplant per DSA declined from 153.9 days (95% CI, 143.4-164.4 days) pre-policy to 89.6 days (95% CI, 83.1-96.1 days) post-policy (p < 0.001). A larger decrease in waitlist time was associated with a higher proportion of exported hearts. CONCLUSIONS: The 2018 heart allocation policy was associated with more uniform access to heart transplantation and improved waitlist outcomes.

Racial Inequities in Access to Ventricular Assist Device and Transplant Persist After Consideration for Preferences for Care: A Report From the REVIVAL Study.

BACKGROUND: Racial disparities in access to advanced therapies for heart failure (HF) patients are well documented, although the reasons remain uncertain. We sought to determine the association of race on utilization of ventricular assist device (VAD) and transplant among patients with access to care at VAD centers and if patient preferences impact the effect. METHODS: We performed an observational cohort study of ambulatory chronic systolic HF patients with high-risk features and no contraindication to VAD enrolled at 21 VAD centers and followed for 2 years in the REVIVAL study (Registry Evaluation of Vital Information for VADs in Ambulatory Life). We used competing events cause-specific proportional hazard methodology with multiple imputation for missing data. The primary outcomes were (1) VAD/transplant and (2) death. The exposures of interest included race (Black or White), additional demographics, captured social determinants of health, clinician-assessed HF severity, patient-reported quality of life, preference for VAD, and desire for therapies. RESULTS: The study included 377 participants, of whom 100 (26.5%) identified as Black. VAD or transplant was performed in 11 (11%) Black and 62 (22%) White participants, although death occurred in 18 (18%) Black and 36 (13%) White participants. Black race was associated with reduced utilization of VAD and transplant (adjusted hazard ratio, 0.45 [95% CI, 0.23-0.85]) without an increase in death. Preferences for VAD or life-sustaining therapies were similar by race and did not explain racial disparities. CONCLUSIONS: Among patients receiving care by advanced HF cardiologists at VAD centers, there is less utilization of VAD and transplant for Black patients even after adjusting for HF severity, quality of life, and social determinants of health, despite similar care preferences. This residual inequity may be a consequence of structural racism and discrimination or provider bias impacting decision-making. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01369407.

Failure to rescue: A candidate quality metric for durable left ventricular assist device implantation.

OBJECTIVE: Failure to rescue (FTR), defined as death after a complication, is recognized as a principal driver of variation in mortality among hospitals. We evaluated FTR as a quality metric in patients who received durable left ventricular assist devices (LVADs) using the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support. METHODS: Data on 13,617 patients who received primary durable LVADs from April 2012 to October 2017 at 131 hospitals that performed at least 20 implants were analyzed from the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support. Rates of major complications and FTR were compared across risk-adjusted in-hospital mortality terciles (low, medium, high) and hospital volume. Logistic regression was used to estimate expected FTR rates on the basis of patient factors for each major complication. RESULTS: The overall unadjusted in-hospital mortality rate was 6.96%. Risk-adjusted in-hospital mortality rates varied 3.1-fold across terciles (low, 3.3%; high, 10.3%; P trend <.001). Rates of major complications varied 1.1-fold (low, 34.0%; high, 38.8%; P < .0001). Among patients with a major complication, 854 died in-hospital for an FTR rate of 17.7%, with 2.8-fold variation across mortality terciles (low, 8.5%; high, 23.9%; P < .0001). FTR rates were highest for renal dysfunction requiring dialysis (45.3%) and stroke (36.5%). Higher average annual LVAD volume was associated with higher rates of major complications (<10 per year, 26.7%; 10-20 per year, 34.0%; 20-30 per year, 34.0%; >30 per year, 40.1%; P trend <.0001) whereas hospitals implanting <10 per year had the highest FTR rate (<10 per year, 23.5%; 10-20 per year, 16.5%; 20-30 per year, 17.0%; >30 per year, 17.9%; P = .03). CONCLUSIONS: FTR might serve as an important quality metric for durable LVAD implant procedures, and identifying strategies for successful rescue after complications might reduce hospital variations in mortality.

Comparison of Evaluations for Heart Transplant Before Durable Left Ventricular Assist Device and Subsequent Receipt of Transplant at Transplant vs Nontransplant Centers.

Importance: In 2020, the Centers for Medicare & Medicaid Services revised its national coverage determination, removing the requirement to obtain review from a Medicare-approved heart transplant center to implant a durable left ventricular assist device (LVAD) for bridge-to-transplant (BTT) intent at an LVAD-only center. The association between center-level transplant availability and access to heart transplant, the gold-standard therapy for advanced heart failure (HF), is unknown. Objective: To investigate the association of center transplant availability with LVAD implant strategies and subsequent heart transplant following LVAD implant before the Centers for Medicare & Medicaid Services policy change. Design, Setting, and Participants: A retrospective cohort study of the Society of Thoracic Surgeons Intermacs multicenter US registry database was conducted from April 1, 2012, to June 30, 2020. The population included patients with HF receiving a primary durable LVAD. Exposures: LVAD center transplant availability (LVAD/transplant vs LVAD only). Main Outcomes and Measures: The primary outcomes were implant strategy as BTT and subsequent transplant by 2 years. Covariates that might affect listing strategy and outcomes were included (eg, patient demographic characteristics, comorbidities) in multivariable models. Parameters for BTT listing were estimated using logistic regression with center-level random effects and for receipt of a transplant using a Cox proportional hazards regression model with death as a competing event. Results: The sample included 22 221 LVAD recipients with a median age of 59.0 (IQR, 50.0-67.0) years, of whom 17 420 (78.4%) were male and 3156 (14.2%) received implants at LVAD-only centers. Receiving an LVAD at an LVAD/transplant center was associated with a 79% increased adjusted odds of BTT LVAD designation (odds ratio, 1.79; 95% CI, 1.35-2.38; P < .001). The 2-year transplant rate following LVAD implant was 25.6% at LVAD/transplant centers and 11.9% at LVAD-only centers. There was an associated 33% increased rate of transplant at LVAD/transplant centers compared with LVAD-only centers (adjusted hazard ratio, 1.33; 95% CI, 1.17-1.51) with a similar hazard for death at 2 years (adjusted hazard ratio, 0.99; 95% CI, 0.90-1.08). Conclusions and Relevance: Receiving an LVAD at an LVAD-transplant center was associated with increased odds of BTT intent at implant and subsequent transplant receipt for patients at 2 years. The findings of this study suggest that Centers for Medicare & Medicaid Services policy change may have the unintended consequence of further increasing inequities in access to transplant among patients at LVAD-only centers.

Role of the mitral valve in left ventricular assist device pathophysiology.

Functional mitral regurgitation (MR) in the setting of heart failure results from progressive dilatation of the left ventricle (LV) and mitral annulus. This leads to leaflet tethering with posterior displacement. Contrary to common assumptions, MR often does not resolve with LVAD decompression of the LV alone. The negative impact of significant (moderate-severe) mitral regurgitation in the LVAD setting is becoming better recognized in terms of its harmful effect on right heart function, pulmonary vascular resistance and hospital readmissions. However, controversies remain regarding the threshold for intervention and management. At present, there are no consensus indications for the repair of significant mitral regurgitation at the time of LVAD implantation due to the conflicting data regarding potential adverse effects of MR on clinical outcomes. In this review, we summarize the current understanding of MR pathophysiology in patients supported with LVAD and potential future management strategies.

Racial and Sex Inequities in the Use of and Outcomes After Left Ventricular Assist Device Implantation Among Medicare Beneficiaries.

Importance: While left ventricular assist devices (LVADs) increase survival for patients with advanced heart failure (HF), racial and sex access and outcome inequities remain and are poorly understood. Objectives: To assess risk-adjusted inequities in access and outcomes for both Black and female patients and to examine heterogeneity in treatment decisions among patients for whom clinician discretion has a more prominent role. Design, Setting, and Participants: This retrospective cohort study of 12 310 Medicare beneficiaries used 100% Medicare Fee-for-Service administrative claims. Included patients had been admitted for heart failure from 2008 to 2014. Data were collected from July 2007 to December 2015 and analyzed from August 23, 2020, to May 15, 2022. Exposures: Beneficiary race and sex. Main Outcomes and Measures: The propensity for LVAD implantation was based on clinical risk factors from the 6 months preceding HF admission using XGBoost and the synthetic minority oversampling technique. Beneficiaries with a 5% or greater probability of receiving an LVAD were included. Logistic regression models were estimated to measure associations of race and sex with LVAD receipt adjusting for clinical characteristics and social determinants of health (eg, distance from LVAD center, Medicare low-income subsidy, neighborhood deprivation). Next, 1-year mortality after LVAD was examined. Results: The analytic sample included 12 310 beneficiaries, of whom 22.9% (n = 2819) were Black and 23.7% (n = 2920) were women. In multivariable models, Black beneficiaries were 3.0% (0.2% to 5.8%) less likely to receive LVAD than White beneficiaries, and women were 7.9% (5.6% to 10.2%) less likely to receive LVAD than men. Individual poverty and worse neighborhood deprivation were associated with reduced use, 2.9% (0.4% to 5.3%) and 6.7% (2.9% to 10.5%), respectively, but these measures did little to explain observed disparities. The racial disparity was concentrated among patients with a low propensity score (propensity score <0.52). One-year survival by race and sex were similar on average, but Black patients with a low propensity score experienced improved survival (7.2% [95% CI, 0.9% to 13.5%]). Conclusions and Relevance: In this cohort study of Medicare beneficiaries hospitalized for HF, disparities in LVAD use by race and sex existed and were not explained by clinical characteristics or social determinants of health. The treatment and post-LVAD survival by race were equivalent among the most obvious LVAD candidates. However, there was differential use and outcomes among less clear-cut LVAD candidates, with lower use but improved survival among Black patients. Inequity in LVAD access may have resulted from differences in clinician decision-making because of systemic racism and discrimination, implicit bias, or patient preference.

Association between biventricular pacing and incidence of ventricular arrhythmias in the early post-operative period after left ventricular assist device implantation.

INTRODUCTION: Cardiac resynchronization therapy (CRT) and left ventricular assist devices (LVAD) improve outcomes in heart failure patients. Early ventricular arrhythmias (VA) are common after LVAD and are associated with increased mortality. The association between left ventricular pacing (LVP) with CRT and VAs in the early post-LVAD period remains unclear. METHODS: This was a retrospective study of all patients undergoing LVAD implantation from 1/2016 to 12/2019. Patients were divided into those with CRT and active LVP (CRT-LVP) immediately post-LVAD implant versus those without CRT-LVP. Implantable cardiac defibrillator electrograms were reviewed and early VAs were defined as sustained ventricular tachycardia (VT)/ventricular fibrillation occurring within 30 days of LVAD implantation. RESULTS: Of 186 included patients (mean age 53 years, 75% male, mean body mass index 28), 72 had CRT devices, 63 of whom had LV pacing enabled after LVAD implant (CRT-LVP group). Patients with CRT-LVP were more likely to have VA in the early postoperative period (21% vs. 4%; p = .0001). All 9 patients with CRT in whom LVP was disabled had no early VA. Among those with early VA, patients with CRT-LVP were more likely to have monomorphic VT (77% vs. 40%; p = .07). In multiple logistic regression, CRT-LVP pacing remained an independent predictor of early VA after adjustment for history of VA and AF. CONCLUSIONS: Patients with CRT-LVP after LVAD implant had a higher incidence of early VA (specifically monomorphic VT). Epicardial LV pacing may be proarrhythmic in the early postoperative period after LVAD.

Advancing Quality Metrics for Durable Left Ventricular Assist Device Implant: Analysis of the Society of Thoracic Surgeons Intermacs Database.

BACKGROUND: Patients undergoing left ventricular assist device (LVAD) implantation are at risk for death and postoperative adverse outcomes. Interhospital variability and concordance of quality metrics were assessed using the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs). METHODS: A total of 22 173 patients underwent primary, durable LVAD implantation across 160 hospitals from 2012 to 2020, excluding hospitals performing <10 implant procedures. Observed and risk-adjusted operative mortality rates were calculated for each hospital. Outcomes included operative and 90-day mortality, a composite of adverse events (operative mortality, bleeding, stroke, device malfunction, renal dysfunction, respiratory failure), and secondarily failure to rescue. Rates are presented as median (interquartile range [IQR]). Hospital performance was evaluated using observed-to-expected (O/E) ratios for mortality and the composite outcome. RESULTS: Interhospital variability existed in observed (median, 7.2% [IQR, 5.1%-9.6%]) mortality. The rates of adverse events varied across hospitals: major bleeding, 15.6% (IQR, 11.4%-22.4%); stroke, 3.1% (IQR, 1.6%-4.7%); device malfunction, 2.4% (IQR, 0.8%-3.7%); respiratory failure, 10.5% (IQR, 4.6%-15.7%); and renal dysfunction, 6.4% (IQR, 3.2%-9.6%). The O/E ratio for operative mortality varied from 0.0 to 6.1, whereas the O/E ratio for the composite outcome varied from 0.28 to 1.99. Hospital operative mortality O/E ratios were more closely correlated with the 90-day mortality O/E ratio (r = 0.74) than with the composite O/E ratio (r = 0.12). CONCLUSIONS: This study reported substantial interhospital variability in performance for hospitals implanting durable LVADs. These findings support the need to (1) report hospital-level performance (mortality, composite) and (2) undertake benchmarking activities to reduce unwarranted variability in outcomes.

An early relook identifies high-risk trajectories in ambulatory advanced heart failure.

INTRODUCTION: Patients with ambulatory advanced heart failure (HF) are increasingly considered for durable mechanical circulatory support (MCS) and heart transplantation and their effective triage requires careful assessment of the clinical trajectory. METHODS: REVIVAL, a prospective, observational study, enrolled 400 ambulatory advanced HF patients from 21 MCS/transplant centers in 2015-2016. Study design included a clinical re-assessment of Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile within 120 days after enrollment. The prognostic impact of a worsening INTERMACS Profile assigned by the treating physician was assessed at 1 year after the Early Relook. RESULTS: Early Relook was done in 325 of 400 patients (81%), of whom 24% had a worsened INTERMACS Profile, associated with longer HF history and worse baseline INTERMACS profile, but no difference in baseline LVEF (median 0.20), 6-minute walk, quality of life, or other baseline parameters. Early worsening predicted higher rate of the combined primary endpoint of death, urgent MCS, or urgent transplant by 1 year after Early Relook, (28% vs 15%), with hazard ratio 2.2 (95% CI 1.2- 3.8; p = .006) even after adjusting for baseline INTERMACS Profile and Seattle HF Model score. Deterioration to urgent MCS occurred in 14% vs 5% (p = .006) during the year after Early Relook. CONCLUSIONS: Early Relook identifies worsening of INTERMACS Profile in a significant population of ambulatory advanced HF, who had worse outcomes over the subsequent year. Early reassessment of ambulatory advanced HF patients should be performed to better define the trajectory of illness and inform triage to advanced therapies.

A challenge to equity in transplantation: Increased center-level variation in short-term mechanical circulatory support use in the context of the updated U.S. heart transplant allocation policy.

BACKGROUND: The United States National Organ Procurement Transplant Network (OPTN) implemented changes to the adult heart allocation system to reduce waitlist mortality by improving access for those at greater risk of pre-transplant death, including patients on short-term mechanical circulatory support (sMCS). While sMCS increased, it is unknown whether the increase occurred equitably across centers. METHODS: The OPTN database was used to assess changes in use of sMCS at time of transplant in the 12 months before (pre-change) and after (post-change) implementation of the allocation system in October 2018 among 5,477 heart transplant recipients. An interrupted time series analysis comparing use of bridging therapies pre- and post-change was performed. Variability in the proportion of sMCS use at the center level pre- and post-change was determined. RESULTS: In the month pre-change, 9.7% of patients were transplanted with sMCS. There was an immediate increase in sMCS transplant the following month to 32.4% - an absolute and relative increase of 22.7% and 312% (p < 0.001). While sMCS use was stable pre-change (monthly change 0.0%, 95% CI [-0.1%,0.1%]), there was a continuous 1.2%/month increase post-change ([0.6%,1.8%], p < 0.001). Center-level variation in sMCS use increased substantially after implementation, from a median (interquartile range) of 3.85% (10%) pre-change to 35.7% (30.6%) post-change (p < 0.001). CONCLUSIONS: Use of sMCS at time of transplant increased immediately and continued to expand following heart allocation policy changes. Center-level variation in use of sMCS at the time of transplant increased compared to pre-change, which may have negatively impacted equitable access to heart transplantation.