Achieving Equity in Hospital Performance Assessments Using Composite Race-Specific Measures of Risk-Standardized Readmission and Mortality Rates for Heart Failure.

BACKGROUND: The contemporary measures of hospital performance for heart failure hospitalization and 30-day risk-standardized readmission rate (RSRR) and risk-standardized mortality rate (RSMR) are estimated using the same risk adjustment model and overall event rate for all patients. Thus, these measures are mainly driven by the care quality and outcomes for the majority racial and ethnic group, and may not adequately represent the hospital performance for patients of Black and other races. METHODS: Fee-for-service Medicare beneficiaries from January 2014 to December 2019 hospitalized with heart failure were identified. Hospital-level 30-day RSRR and RSMR were estimated using the traditional race-agnostic models and the race-specific approach. The composite race-specific performance metric was calculated as the average of the RSRR/RMSR measures derived separately for each race and ethnicity group. Correlation and concordance in hospital performance for all patients and patients of Black and other races were assessed using the composite race-specific and race-agnostic metrics. RESULTS: The study included 1 903 232 patients (75.7% White [n=1 439 958]; 14.5% Black [n=276 684]; and 9.8% other races [n=186 590]) with heart failure from 1860 hospitals. There was a modest correlation between hospital-level 30-day performance metrics for patients of White versus Black race (Pearson correlation coefficient: RSRR=0.42; RSMR=0.26). Compared with the race-agnostic RSRR and RSMR, composite race-specific metrics for all patients demonstrated stronger correlation with RSRR (correlation coefficient: 0.60 versus 0.74) and RSMR (correlation coefficient: 0.44 versus 0.51) for Black patients. Concordance in hospital performance for all patients and patients of Black race was also higher with race-specific (versus race-agnostic) metrics (RSRR=64% versus 53% concordantly high-performing; 61% versus 51% concordantly low-performing). Race-specific RSRR and RSMR metrics (versus race-agnostic) led to reclassification in performance ranking of 35.8% and 39.2% of hospitals, respectively, with better 30-day and 1-year outcomes for patients of all race groups at hospitals reclassified as high-performing. CONCLUSIONS: Among patients hospitalized with heart failure, race-specific 30-day RSMR and RSRR are more equitable in representing hospital performance for patients of Black and other races.

Characterization of left atrial assist device implantation: Early results of ex vivo anatomical assessment.

BACKGROUND: The left atrial assist device (LAAD) is a novel pump that was developed specifically for the treatment of heart failure with preserved ejection fraction. The device is surgically implanted in the mitral position. This study aimed to characterize the various device-fitting configurations in the mitral annular position. METHODS: Rapidly prototyped LAAD models (n = 5) were fabricated with five different driveline configurations: (A) annulus level/intra-cuff running; (B) supra-cuff/below coronary sinus (CS); (C) infra-cuff; (D) supra-annulus/supra-CS; (E) left ventricular free wall level. The 3D-printed models were implanted in extracted fresh porcine hearts (80-100 kg, adult, healthy porcine) and the proximity of anatomical structures between the driveline and CS and coronary artery (CA) were measured. RESULTS: All five device configurations were evaluated for fitting. For the purpose of preventing blood clot formation around the driveline, the mitral annulus (MA) as a driveline pass-way (configuration A) has been considered advantageous with the current device, in that the driveline exposure to blood has been avoided. The CS does not exist at exactly the same level as the MA, and there is less risk of injuring it than using the left atrial free wall. However, there is an inevitable risk of damaging the CA, so careful visual inspection before inserting the driveline is needed. CONCLUSIONS: Several options of driveline exteriorization were demonstrated, and the safety of each configuration was evaluated. Using the MA as a pathway for the driveline exit is considered to be a reasonable and safe method.

Incidence and Prognostic Implications of Readmissions Caused by Thrombotic Events After a Heart Failure Hospitalization.

Background Readmission occurs in 1 out of 3 patients with heart failure (HF). We aimed to study the incidence and prognostic implications of rehospitalizations because of arterial thromboembolism events (ATEs) and venous thromboembolism events (VTEs) after discharge in patients with HF. Methods and Results We identified Medicare beneficiaries who were admitted with a primary diagnosis of HF from 2014 to 2019, with a hospital stay ranging between 3 and10 days, followed by discharge to home. We calculated incidence of ATEs (myocardial infarction, ischemic stroke, or systemic embolism) and VTEs (deep venous thrombosis and pulmonary embolism) up to 90 days after discharge. Out of 2 953 299 patients admitted with HF during the study period, a total of 585 353 patients met the inclusion criteria, and 36.6% were readmitted within 90 days of discharge. The incidence of readmission due ATEs, VTEs, HF, and all other reasons was 3.4%, 0.5%, 13.2%, and 19.5%, respectively. Incidence of thromboembolic events was highest within 14 days after discharge. Factors associated with ATEs included prior coronary, peripheral, or cerebrovascular disease and for VTEs included malignancy and prior liver or lung disease. ATE/VTE readmission had a 30-day mortality of 19.9%. After a median follow-up period of 25.6 months, ATE and VTE readmissions were associated with higher risk of mortality (hazard ratio, 2.76 [95% CI, 2.71-2.81] and 2.17 [95% CI, 2.08-2.27], respectively; P<0.001 for both) compared with no readmission on time-dependent Cox regression. Conclusions After a HF hospitalization, 3.9% of patients were readmitted with a thromboembolic event that was associated with 2- to 3-fold greater risk of mortality in follow-up.

Outcomes of bariatric surgery in patients with left ventricular assist device.

BACKGROUND: Class II obesity affects 1 in 5 patients with left ventricular assist device (LVAD) and is considered a potential barrier to heart transplantation (HT). Studies about the outcomes of bariatric surgery in this population are scarce. METHODS: We identified Medicare beneficiaries who had an LVAD placed from 2012 to 2019 and had at least class II obesity at the time of LVAD placement and identified patients who underwent bariatric surgery during or after the LVAD implantation admission. The primary outcome was major adverse cardiovascular events (MACE) at 30 days (mortality, cerebral hemorrhage, or ischemic stroke) after bariatric surgery. RESULTS: Among patients who underwent LVAD implantation from 2012 to 2019, 2798 (19.4%) had at least class II obesity, and 198 (7.1%) patients had bariatric surgery (24 on same admission and 174 after a median of 702 days). After bariatric surgery in LVAD patients, 30-day MACE was 6.1%, 30-day mortality was <5.5%, and 1-year mortality was 12.6%. Heart failure readmission burden declined after bariatric surgery (incidence rate ratio 0.20 (95% CI 0.11-0.38), p < 0.001). Thirty-seven patients underwent HT after a median of 371 days (IQR 246-575 days), and 13 patients underwent LVAD explant due to recovery. On time-dependent, competing risk, Cox regression, bariatric surgery was associated with a 3-fold higher probability of HT in follow-up compared to patients who did not get bariatric surgery (sub-distribution HR 2.95, 95% CI 2.09-4.17, p < 0.001). CONCLUSIONS: Bariatric surgery in patients with LVAD support is associated with decreased heart failure events and higher chances of heart transplantation.

Dynamic Assessment of Pulmonary Artery Pulsatility Index Provides Incremental Risk Assessment for Early Right Ventricular Failure After Left Ventricular Assist Device.

BACKGROUND: The pulmonary artery pulsatility index (PAPi) has been studied to predict right ventricular failure (RVF) after left ventricular assist device (LVAD) implantation, but only as a single time point before LVAD implantation. Multiple clinical factors and therapies impact RV function in pre-LVAD patients. Thus, we hypothesized that serial PAPi measurements during cardiac intensive care unit (CICU) optimization before LVAD implantation would provide incremental risk stratification for early RVF after LVAD implantation. METHODS AND RESULTS: Consecutive patients who underwent sequential pulmonary artery catherization with cardiac intensive care optimization before durable LVAD implantation were included. Serial hemodynamics were reviewed retrospectively across the optimization period. The optimal PAPi was defined by the initial PAPi + the PAPi at optimized hemodynamics. RVF was defined as need for a right ventricular assist device or prolonged inotrope use (>14 days postoperatively). Patients with early RVF had significantly lower mean optimal PAPi (3.5 vs 7.5, P < .001) compared with those who did not develop RVF. After adjusting for established risk factors of early RVF after LVAD implantation, the optimal PAPi was independently and incrementally associated with early RVF after LVAD implantation (odds ratio 0.64, 95% confidence interval 0.532-0.765, P < .0001). CONCLUSIONS: Optimal PAPi achieved during medical optimization before LVAD implantation provides independent and incremental risk stratification for early RVF, likely identifying dynamic RV reserve.

Virtual Visits for Care of Patients with Heart Failure in the Era of COVID-19: A Statement from the Heart Failure Society of America.

In response to the COVID-19 pandemic, US federal and state governments have implemented wide-ranging stay-at-home recommendations as a means to reduce spread of infection. As a consequence, many US healthcare systems and practices have curtailed ambulatory clinic visits-pillars of care for patients with heart failure (HF). In this context, synchronous audio/video interactions, also known as virtual visits (VVs), have emerged as an innovative and necessary alternative. This scientific statement outlines the benefits and challenges of VVs, enumerates changes in policy and reimbursement that have increased the feasibility of VVs during the COVID-19 era, describes platforms and models of care for VVs, and provides a vision for the future of VVs.

ACC/AATS/AHA/ASE/ASNC/HRS/SCAI/SCCT/SCMR/STS 2019 Appropriate Use Criteria for Multimodality Imaging in the Assessment of Cardiac Structure and Function in Nonvalvular Heart Disease: A Report of the American College of Cardiology Appropriate Use Criteria Task Force, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and the Society of Thoracic Surgeons.

This document is the second of 2 companion appropriate use criteria (AUC) documents developed by the American College of Cardiology, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons. The first document1 addresses the evaluation and use of multimodality imaging in the diagnosis and management of valvular heart disease, whereas this document addresses this topic with regard to structural (nonvalvular) heart disease. While dealing with different subjects, the 2 documents do share a common structure and feature some clinical overlap. The goal of the companion AUC documents is to provide a comprehensive resource for multimodality imaging in the context of structural and valvular heart disease, encompassing multiple imaging modalities. Using standardized methodology, the clinical scenarios (indications) were developed by a diverse writing group to represent patient presentations encountered in everyday practice and included common applications and anticipated uses. Where appropriate, the scenarios were developed on the basis of the most current American College of Cardiology/American Heart Association Clinical Practice Guidelines. A separate, independent rating panel scored the 102 clinical scenarios in this document on a scale of 1 to 9. Scores of 7 to 9 indicate that a modality is considered appropriate for the clinical scenario presented. Midrange scores of 4 to 6 indicate that a modality may be appropriate for the clinical scenario, and scores of 1 to 3 indicate that a modality is considered rarely appropriate for the clinical scenario. The primary objective of the AUC is to provide a framework for the assessment of these scenarios by practices that will improve and standardize physician decision making. AUC publications reflect an ongoing effort by the American College of Cardiology to critically and systematically create, review, and categorize clinical situations in which diagnostic tests and procedures are utilized by physicians caring for patients with cardiovascular diseases. The process is based on the current understanding of the technical capabilities of the imaging modalities examined.

Standardized Psychosocial Assessment Before Left Ventricular Assist Device Implantation.

BACKGROUND: Before consideration of advanced cardiac therapies, guidelines recommend a comprehensive multidisciplinary examination, including psychosocial assessment. The Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT) has emerged as a highly reproducible tool to assess for psychosocial impairment and is associated with negative medical and psychosocial outcomes after transplantation. We sought to assess the association between SIPAT and outcomes after left ventricular assist device. METHODS AND RESULTS: We evaluated 128 patients implanted with a first left ventricular assist device at the Cleveland Clinic from 2013 to 2017 who underwent a prospectively collected quantitative psychosocial assessment using SIPAT. Several survival analyses were performed testing the association between SIPAT score and mortality, first adverse event (defined as hospitalization, device exchange, or death), and recurring adverse events after multivariable adjustment. Median SIPAT score was 14 (interquartile range, 9.5-22.5), with higher values (representing more impairment) seen in patients implanted as destination therapy. After a median follow-up of 349 (interquartile range, 178-684) days, there were 319 adverse events (18 deaths, 10 device exchanges, and 291 readmissions) with 2.5±2.4 events per patient. Higher preimplant SIPAT scores were not associated with mortality ( P=0.764) or time to a first adverse event ( P=0.589) but were associated with cumulative adverse events (hazard ratio, 1.31; 95% CI, 1.09-1.58; P=0.005 per Δ10 in score). In addition, SIPAT was associated with days alive outside of the hospital ( P=0.016). CONCLUSIONS: A standardized assessment of psychosocial impairment after left ventricular assist device using the SIPAT score was not associated with mortality or time to first adverse event but was associated with cumulative adverse cardiac events. This score may provide insight when structuring mitigation strategies for high-risk patients and should be further tested in a prospective multicenter study.

The Management of Acute Ischemic Strokes and the Prevalence of Large Vessel Occlusion in Left Ventricular Assist Device.

BACKGROUND: Ischemic and hemorrhagic strokes are frequent complications among those with left ventricular assist device (LVAD). Scarce data exist regarding the prevalence of acute large vessel occlusion (LVO) and treatment of acute ischemic stroke (AIS) in this setting. METHODS: We reviewed prospectively collected data of LVAD patient registry from a single, tertiary center from October 2004 to November 2016. Among those with AIS complications, patients were divided into early stroke (during implantation hospitalization) and late stroke (post-discharge) groups, and neuroimaging was reviewed and data on acute stroke therapy were collected. RESULTS: Of 477 persons with LVAD, 49 (10.3%) AIS occurred. The majority (29/49, 59%) of AIS occurred in-hospital. Thirty-two (65%) persons had international normalized ratios less than 1.7 at the time of AIS, but none qualified to receive acute intravenous thrombolysis. Of 25 (51%) persons who underwent CT angiography (CTA), 33% (16/49) had acute LVOs. Thirty-one percent (5/16) of persons with acute LVOs underwent intra-arterial endovascular therapy. All of 5 cases presented with middle cerebral artery syndrome with a median pre-procedural National Institutes of Health Stroke Scale of 13 (interquartile range 10-18). Successful recanalization was achieved in all 5 cases. CONCLUSIONS: In-hospital strokes and acute LVOs are common in LVAD-associated AIS. Prompt evaluation with CTA and endovascular therapy should be pursued for these critically ill patients.

Prospective assessment of combined handgrip strength and Mini-Cog identifies hospitalized heart failure patients at increased post-hospitalization risk.

AIMS: The utility of combined assessment of both frailty and cognitive impairment in hospitalized heart failure (HF) patients for incremental post-discharge risk stratification, using handgrip strength and Mini-Cog as feasible representative parameters, was investigated. METHODS AND RESULTS: A prospective, single-centre cohort study of older adults (age ≥65) hospitalized for HF being discharged to home was performed. Pre-discharge, grip strength was assessed using a dynamometer (Jamar hydrolic hand dynamometer, Lafayette Instruments, Lafayette, IN, USA) and was defined as weak if the maximal value was below the gender-derived and body mass index-derived cut-offs according to Fried criteria. Cognition was assessed using the Mini-Cog. The presence of impairment was defined as a score of <2. Outcome measures were all-cause readmission or emergency department visit (primary) or all-cause mortality (secondary) at 6 months. A total of 56 patients (mean age 77 ± 7 years, 73% male) were enrolled. The majority (n = 33, 59%) had weak grip strength, either with (n = 5) or without (n = 28) cognitive impairment. The highest risk for both readmission and mortality occurred in those with weak grip strength and cognitive impairment in combination (log-rank P < 0.0001 and P = 0.01, respectively). CONCLUSIONS: Patients who are frail by grip strength assessment and cognitively impaired according to severely reduced Mini-Cog performance show the worst midterm post-discharge outcomes after HF hospitalization.

Utility of the Psychosocial Assessment of Candidates for Transplantation in Patients Undergoing Continuous-Flow Left Ventricular Assist Device Implantation.

PURPOSE: Psychosocial assessment of patients comprises an important element in the selection process of appropriate candidates for left ventricular assist device (LVAD) implantation. We sought to determine the association of the well-validated psychosocial assessment of candidates for transplantation (PACT) scale to clinical outcomes post-LVAD implantation. MATERIALS AND METHODS: The PACT scale was used retrospectively to reconstruct psychosocial profiles of all patients who underwent a continuous-flow LVAD implantation for all indications at our institution between March 2008 and August 2012 (N = 230). Psychosocial elements including social support, psychological health, lifestyle factors, comprehension of the operation, and follow-up were evaluated. The primary outcome was overall survival, and the secondary outcomes were hospital readmission, pump thrombosis, hemolysis, gastrointestinal (GI) bleeding, and LVAD driveline infections. RESULTS: The mean age of patients was 55.3 years, with 83% being male; 58% (N = 135) were bridge to transplant and 42% (N = 95) were destination therapy. Up to 1-year post-LVAD implant, there were no statistical differences among the 5 PACT candidate groups in terms of survival ( P = .79), hospital readmissions ( P = .55), suspected or confirmed pump thrombosis ( P = .31), hemolysis ( P = .43), GI bleeding ( P = .71), or driveline infections ( P = .06). CONCLUSIONS: In this single-center retrospective review, post hoc reconstruction of psychosocial profiles using the PACT scale and independent assessment of postimplant outcomes, including survival and adverse events, did not show any association. However, given the small number of patients in the low score PACT groups as well as limited duration of follow-up, further studies are required to elucidate the association.

Sensitization in Transplantation: Assessment of Risk (STAR) 2017 Working Group Meeting Report.

The presence of preexisting (memory) or de novo donor-specific HLA antibodies (DSAs) is a known barrier to successful long-term organ transplantation. Yet, despite the fact that laboratory tools and our understanding of histocompatibility have advanced significantly in recent years, the criteria to define presence of a DSA and assign a level of risk for a given DSA vary markedly between centers. A collaborative effort between the American Society for Histocompatibility and Immunogenetics and the American Society of Transplantation provided the logistical support for generating a dedicated multidisciplinary working group, which included experts in histocompatibility as well as kidney, liver, heart, and lung transplantation. The goals were to perform a critical review of biologically driven, state-of-the-art, clinical diagnostics literature and to provide clinical practice recommendations based on expert assessment of quality and strength of evidence. The results of the Sensitization in Transplantation: Assessment of Risk (STAR) meeting are summarized here, providing recommendations on the definition and utilization of HLA diagnostic testing, and a framework for clinical assessment of risk for a memory or a primary alloimmune response. The definitions, recommendations, risk framework, and highlighted gaps in knowledge are intended to spur research that will inform the next STAR Working Group meeting in 2019.

Patient-Reported Health-Related Quality of Life Is a Predictor of Outcomes in Ambulatory Heart Failure Patients Treated With Left Ventricular Assist Device Compared With Medical Management: Results From the ROADMAP Study (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management).

BACKGROUND: The prospective observational ROADMAP study (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management) demonstrated that ambulatory advanced heart failure patients selected for left ventricular assist device (LVAD) were more likely to be alive at 1 year on original therapy with ≥75-m improvement in 6-minute walk distance compared with patients assigned to optimal medical management. Whether baseline health-related quality of life (hrQoL) resulted in a heterogeneity of this treatment benefit is unknown. METHODS AND RESULTS: Patient-reported hrQoL was assessed with EuroQol questionnaire and visual analogue scale (VAS). We aimed to identify predictors of event-free survival and survival with acceptable hrQoL (VAS≥60). LVAD patients had significant improvement in 3 of 5 EuroQol dimensions (P<0.05), but no significant changes were observed with optimal medical management. Among patients with baseline VAS<55, survival on original treatment was lower for optimal medical management patients compared with those assigned to LVAD (58±7% versus 82±5%; P=0.004). No such difference was seen if baseline VAS was ≥55 (70±7% versus 75±9%; P=0.79). Survival on original therapy with acceptable quality of life was also more likely with LVAD versus optimal medical management if baseline VAS was <55, whereas outcomes in patients with higher baseline VAS scores were similar regardless of treatment assignment (P=0.046 for treatment arm and baseline VAS interaction). CONCLUSIONS: LVAD therapy resulted in improvement of patient health status in heart failure patients with low self-reported hrQoL, but not in patients with acceptable quality of life at the time of LVAD implantation. Patient-reported hrQoL should be integrated into decision making concerning the use and timing of LVAD therapy in heart failure patients who are symptom limited but remain ambulatory. CLINICAL TRIAL REGISTRATION: URL: http://www.ClinicalTrials.gov. Unique identifier: NCT01452802.

Accuracy of Seattle Heart Failure Model and HeartMate II Risk Score in Non-Inotrope-Dependent Advanced Heart Failure Patients: Insights From the ROADMAP Study (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients).

BACKGROUND: Timing of left ventricular assist device (LVAD) implantation in advanced heart failure patients not on inotropes is unclear. Relevant prediction models exist (SHFM [Seattle Heart Failure Model] and HMRS [HeartMate II Risk Score]), but use in this group is not established. METHODS AND RESULTS: ROADMAP (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) is a prospective, multicenter, nonrandomized study of 200 advanced heart failure patients not on inotropes who met indications for LVAD implantation, comparing the effectiveness of HeartMate II support versus optimal medical management. We compared SHFM-predicted versus observed survival (overall survival and LVAD-free survival) in the optimal medical management arm (n=103) and HMRS-predicted versus observed survival in all LVAD patients (n=111) using Cox modeling, receiver-operator characteristic (ROC) curves, and calibration plots. In the optimal medical management cohort, the SHFM was a significant predictor of survival (hazard ratio=2.98; P<0.001; ROC area under the curve=0.71; P<0.001) but not LVAD-free survival (hazard ratio=1.41; P=0.097; ROC area under the curve=0.56; P=0.314). SHFM showed adequate calibration for survival but overestimated LVAD-free survival. In the LVAD cohort, the HMRS had marginal discrimination at 3 (Cox P=0.23; ROC area under the curve=0.71; P=0.026) and 12 months (Cox P=0.036; ROC area under the curve=0.62; P=0.122), but calibration was poor, underestimating survival across time and risk subgroups. CONCLUSIONS: In non-inotrope-dependent advanced heart failure patients receiving optimal medical management, the SHFM was predictive of overall survival but underestimated the risk of clinical worsening and LVAD implantation. Among LVAD patients, the HMRS had marginal discrimination and underestimated survival post-LVAD implantation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01452802.

Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients: The ROADMAP Study 2-Year Results.

OBJECTIVES: The authors sought to provide the pre-specified primary endpoint of the ROADMAP (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) trial at 2 years. BACKGROUND: The ROADMAP trial was a prospective nonrandomized observational study of 200 patients (97 with a left ventricular assist device [LVAD], 103 on optimal medical management [OMM]) that showed that survival with improved functional status at 1 year was better with LVADs compared with OMM in a patient population of ambulatory New York Heart Association functional class IIIb/IV patients. METHODS: The primary composite endpoint was survival on original therapy with improvement in 6-min walk distance ≥75 m. RESULTS: Patients receiving LVAD versus OMM had lower baseline health-related quality of life, reduced Seattle Heart Failure Model 1-year survival (78% vs. 84%; p = 0.012), and were predominantly INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profile 4 (65% vs. 34%; p < 0.001) versus profiles 5 to 7. More LVAD patients met the primary endpoint at 2 years: 30% LVAD versus 12% OMM (odds ratio: 3.2 [95% confidence interval: 1.3 to 7.7]; p = 0.012). Survival as treated on original therapy at 2 years was greater for LVAD versus OMM (70 ± 5% vs. 41 ± 5%; p < 0.001), but there was no difference in intent-to-treat survival (70 ± 5% vs. 63 ± 5%; p = 0.307). In the OMM arm, 23 of 103 (22%) received delayed LVADs (18 within 12 months; 5 from 12 to 24 months). LVAD adverse events declined after year 1 for bleeding (primarily gastrointestinal) and arrhythmias. CONCLUSIONS: Survival on original therapy with improvement in 6-min walk distance was superior with LVAD compared with OMM at 2 years. Reduction in key adverse events beyond 1 year was observed in the LVAD group. The ROADMAP trial provides risk-benefit information to guide patient- and physician-shared decision making for elective LVAD therapy as a treatment for heart failure. (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients [ROADMAP]; NCT01452802).

Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients: Results From the ROADMAP Study.

BACKGROUND: Data for left ventricular assist devices (LVADs) in patients with noninotrope-dependent heart failure (HF) are limited. OBJECTIVES: The goal of this study was to evaluate HeartMate II (HMII) LVAD support versus optimal medical management (OMM) in ambulatory New York Heart Association functional class IIIB/IV patients meeting indications for LVAD destination therapy but not dependent on intravenous inotropic support. METHODS: This was a prospective, multicenter (N = 41), observational study of 200 patients (97 LVAD, 103 OMM). Entry criteria included ≥1 hospitalization for HF in the last 12 months and 6-min walk distance (6MWD) <300 m. The primary composite endpoint was survival on original therapy with improvement in 6MWD ≥75 m at 12 months. RESULTS: LVAD patients were more severely ill, with more patients classified as Interagency Registry for Mechanically Assisted Circulatory Support profile 4 (65% LVAD vs. 34% OMM; p < 0.001) than 5 to 7. More LVAD patients met the primary endpoint (39% LVAD vs. 21% OMM; odds ratio: 2.4 [95% confidence interval: 1.2 to 4.8]; p = 0.012). On the basis of as-treated analysis, 12-month survival was greater for LVAD versus OMM (80 ± 4% vs. 63 ± 5%; p = 0.022) patients. Adverse events were higher in LVAD patients, at 1.89 events/patient-year (EPPY), primarily driven by bleeding (1.22 EPPY), than with OMM, at 0.83 EPPY, primarily driven by worsening HF (0.68 EPPY). Most patients (80% LVAD vs. 62% OMM; p < 0.001) required hospitalizations. Health-related quality of life (HRQol) and depression improved from baseline more significantly with LVADs than with OMM (Δ visual analog scale: 29 ± 25 vs. 10 ± 22 [p < 0.001]; Δ Patient Health Questionnaire-9: -5 ± 7 vs. -1 ± 5 [p < 0.001]). CONCLUSIONS: Survival with improved functional status was better with HMII LVAD compared with OMM. Despite experiencing more frequent adverse events, LVAD patients improved more in HRQol and depression. The results support HMII use in functionally limited, noninotrope-dependent HF patients with poor HRQoL. (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device [LVAD] and Medical Management [ROADMAP]; NCT01452802).