Interagency Registry For Mechanically Assisted Circulatory Support Profile Research Articles

Outcomes of Intracorporeal Continuous and Paracorporeal Pulsatile Ventricular Assist Devices in Pediatric Patients 10-30 kg.

Ventricular assist devices (VADs) have been increasingly implanted in pediatric patients. Paracorporeal VADs are generally chosen when intracorporeal continuous (IC) devices are too large. Superiority between IC and paracorporeal pulsatile (PP) devices remains unclear in smaller pediatric patients. Our study analyzes outcomes of IC and PP VADs in pediatric patients who could be considered for either of these options. Using the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) database, we identified children between 10 and 30 kg who received a VAD between June 2018 and September 2021. Survival and stroke outcomes were analyzed based on VAD type. There were 41 patients in the IC group and 54 patients in the PP group. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile at the time of implant was higher in the PP cohort (p < 0.02). The PP cohort was younger (p < 0.001) and smaller (p < 0.001) than the IC cohort. The diagnosis was similar between cohorts. Overall survival was similar between groups. Stroke was more common in the PP cohort, but did not reach statistical significance (p = 0.07). Discharge was possible only in the IC group, but the discharge rate was low (9.5%). Direct comparisons remain challenging given differences in INTERMACS profiles, age, and size.

Abstract 18270: Interagency Registry for Mechanically Assisted Circulatory Support Profile is Associated With Outcomes in Patients With an Impella 5.5 Ventricular Assist Device

Introduction: The Impella 5.5 left ventricular assist device (LVAD) can provide temporary mechanical circulatory support (MCS) in select patients with advanced heart failure (HF). The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile provides a standardized grading system for advanced HF patients receiving MCS, ranging from most (1) to least severe (7). Hypothesis: The INTERMACS profile is associated with outcomes in patients supported with an Impella 5.5 LVAD. Methods: From 2019-2022, retrospective review of perioperative characteristics, INTERMACS profile and outcomes in patients supported with an Impella 5.5. Results: When stratified by INTERMACS profile, there were 63 patients (28%) in profile 1, 73 (32%) in profile 2, 20 (8.8%) in profile 3, 72 (32%) in profiles 4-7. Indication for Impella 5.5 implant was primarily cardiogenic shock due to chronic HF (81; 52%), acute MI (33; 21%) or postcardiotomy (22; 14%) in profiles 1-3 and Impella 5.5-assisted cardiac interventions (cardiac surgery, VT ablation, PCI) (68; 94%) in profile 4-7 (p&lt;0.01). Composite freedom from death, durable LVAD, or heart transplant occurred for 63 (41%) profile 1-3 and 66 (92%) profile 4-7 patients (p&lt;0.01). Conclusions: Patients with advanced INTERMACS profiles (1-3) primarily underwent Impella 5.5 implant for chronic HF, postcardiotomy, or acute MI cardiogenic shock, whereas patients in profiles 4-7 primarily underwent Impella 5.5-assisted cardiac interventions. Patients with advanced profiles were more often transitioned to durable LVAD or heart transplant, however, also had higher rates of mortality.

Sex-related differences in left ventricular assist device utilization and outcomes: results from the PCHF-VAD registry.

Data on sex and left ventricular assist device (LVAD) utilization and outcomes have been conflicting and mostly confined to US studies incorporating older devices. This study aimed to investigate sex-related differences in LVAD utilization and outcomes in a contemporary European LVAD cohort. This analysis is part of the multicentre PCHF-VAD registry studying continuous-flow LVAD patients. The primary outcome was all-cause mortality. Secondary outcomes included ventricular arrhythmias, right ventricular failure, bleeding, thromboembolism, and the haemocompatibility score. Multivariable Cox regression models were used to assess associations between sex and outcomes. Overall, 457 men (81%) and 105 women (19%) were analysed. At LVAD implant, women were more often in Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 or 2 (55% vs. 41%, P=0.009) and more often required temporary mechanical circulatory support (39% vs. 23%, P=0.001). Mean age was comparable (52.1 vs. 53.4years, P=0.33), and median follow-up duration was 344 [range 147-823] days for women and 435 [range 190-816] days for men (P=0.40). No significant sex-related differences were found in all-cause mortality (hazard ratio [HR] 0.79 for female vs. male sex, 95% confidence interval [CI] [0.50-1.27]). Female LVAD patients had a lower risk of ventricular arrhythmias (HR 0.56, 95% CI [0.33-0.95]) but more often experienced right ventricular failure. No significant sex-related differences were found in other outcomes. In this contemporary European cohort of LVAD patients, far fewer women than men underwent LVAD implantation despite similar clinical outcomes. This is important as the proportion of female LVAD patients (19%) was lower than the proportion of females with advanced HF as reported in previous studies, suggesting underutilization. Also, female patients were remarkably more often in INTERMACS profile 1 or 2, suggesting later referral for LVAD therapy. Additional research in female patients is warranted.

Experience With SynCardia Total Artificial Heart as a Bridge to Transplantation in 100 Patients

BackgroundThe SynCardia temporary total artificial heart (TAH-t) is an effective bridge to transplantation for patients with severe biventricular failure. However, granular single-center data from high-volume centers are lacking. We report our experience with the first 100 TAH-t recipients. MethodsA prospective institutional database was used to identify 100 patients who underwent 101 TAH-t implantations between 2012 and 2022. Patients were stratified and compared according to Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 vs 2 or greater. Median follow-up on device support was 94 days (interquartile range, 33-276), and median follow-up after transplantation was 4.6 years (interquartile range, 2.1-6.0). ResultsOverall, 61 patients (61%) were successfully bridged to transplantation and 39 (39%) died on TAH-t support. Successful bridge rates between INTERMACS profile 1 and INTERMACS profile 2 or greater patients were similar (55.6% [95% CI, 40.4%-68.3%] vs 67.4% [95% CI, 50.5%-79.6%], respectively; P = .50). The most common adverse events (rates per 100 patient-months) on TAH-t support included infection (15.8), ischemic stroke (4.6), reoperation for mediastinal bleeding (3.5), and gastrointestinal bleeding requiring intervention (4.3). The most common cause of death on TAH-t support was multisystem organ failure (n = 20, 52.6%). Thirty-day survival after transplantation was 96.7%; survival at 6 months, 1 year, and 5 years after transplantation was 95.1% (95% CI, 85.4%-98.4%), 86.6% (95% CI, 74.9%-93.0%), and 77.5% (95% CI, 64.2%-86.3%), respectively. ConclusionsAcceptable outcomes can be achieved in the highest acuity patients using the TAH-t as a bridge to heart transplantation.

Characteristics and Outcome of Patients With a History of Cancer Undergoing Durable Left Ventricular Assist Device Implantation.

Patients with cancer (patients with a history of cancer) with advanced heart failure are increasing, but unlikely to be transplanted, and left ventricular assist device (LVAD) is an alternative strategy. This study investigates the characteristics and outcomes of patients with cancer undergoing durable LVAD. Adult patients with a history of cancer who received LVADs were identified from INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) registry: 2008 and 2017. Characteristics and outcomes between patients with cancer and those without cancer were compared, and subgroup analyses of cancer therapy-induced cardiomyopathy (CCM) and non-CCM were also conducted. Overall, 1273 (6.5%) patients had a history of cancer, including 289 (22.7%) with CCM and 984 (77.3%) with non-CCM as the primary reason for heart failure. Patients with cancer had shorter median survival (3.72 versus 3.97 years, log-rank P=0.002), and multivariable Cox and competing risk regressions revealed that a history of cancer was associated with reduced survival (hazard ratio, 1.14 [95% CI, 1.04-1.26]; P=0.005; subdistribution hazard ratio, 1.24 [95% CI, 1.13-1.36]; P<0.001) and decreased incidence of heart transplantation. There was no significant difference in mortality between patients with CCM-induced heart failure and patients without cancer. Patients with cancer experienced an increased risk of bleeding, and age, INTERMACS profile, albumin, dialysis, and blood urea nitrogen were associated with mortality in these patients. A history of cancer is associated with mildly reduced survival, lower incidence of heart transplantation, and increased risk of bleeding after LVAD, whereas the survival in patients with cancer with CCM-induced heart failure is similar to those without cancer. LVAD implantation in patients with cancer is very well possible.

Explainable Machine Learning Analysis of Right Heart Failure After Left Ventricular Assist Device Implantation.

Right heart failure (RHF) remains a common and serious complication after durable left ventricular assist device (LVAD) implantation. We used explainable machine learning (ML) methods to derive novel insights into preimplant patient factors associated with RHF. Continuous-flow LVAD implantations from 2008 to 2017 in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) were included. A total of 186 preimplant patient factors were analyzed and the primary outcome was 30 days of severe RHF. A boosted decision tree ML algorithm and an explainable ML method were applied to identify the most important factors associated with RHF, nonlinear relationships and interactions, and risk inflection points. Out of 19,595 patients, 19.1% developed severe RHF at 30 days. Thirty top predictors of RHF were identified with the top five being INTERMACS profile, Model for End-stage Liver Disease score, the number of inotropic infusions, hemoglobin, and race. Many top factors exhibited nonlinear relationships with key risk inflection points such as INTERMACS profile between 2 and 3, right atrial pressure of 15 mmHg, pulmonary artery pressure index of 3, and prealbumin of 23 mg/dl. Finally, the most important variable interactions involved INTERMACS profile and the number of inotropes. These insights could help formulate patient optimization strategies prior to LVAD implantation.

Outcomes of Intracorporeal Continuous, Paracorporeal Continuous, and Paracorporeal Pulsatile Ventricular Assist Devices in Pediatric Patients 10-30 kg

<h3>Purpose</h3> In the past decade, ventricular assist devices (VADs) have been increasingly implanted in pediatric patients. Although no definitive size standards exist, paracorporeal VADs are generally chosen when intracorporeal continuous (IC) devices are deemed too large for smaller patients. Superiority between IC, paracorporeal continuous (PC) and paracorporeal pulsatile (PP) devices remains unclear in smaller pediatric patients. Our study analyzes outcomes of IC, PC and PP VADs in pediatric patients who could be considered for any of these options. <h3>Methods</h3> Using the Advanced Cardiac Therapies Improving Outcomes Network(ACTION) database, we identified children between 10 and 30 kg who were supported on a VAD between June 2018 and September 2021. Survival and stroke outcomes were analyzed based on VAD type. <h3>Results</h3> Patient demographics, survival outcomes and stroke rates are displayed in Table 1. Patient diagnosis was similar amongst all three cohorts. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile at time of implant was similar in all groups except when comparing the IC vs PP cohorts (p = 0.03). The PP and PC cohorts were younger (p<0.001) and smaller (p<0.001) than the IC cohort. The number of device days was highest in the IC cohort. Overall survival was similar between groups. Stroke rate was higher in the PP group, but without statistical significance. Discharge was possible only in the IC group, but the discharge rate was low (9.5%). <h3>Conclusion</h3> There was difference in overall survival rates between the IC, PC and PP cohorts. Rates of stroke were highest in the PP cohort, but without statistical significance. Diagnosis and INTERMACS profile were similar with the exception of the IC vs PP cohorts, but direct comparisons remain challenging given differences in age and size. Future studies are needed to compare outcomes in these devices especially given size constraints in smaller pediatric patients.

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

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. 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. 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. 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.

The ever-changing field of mechanical circulatory support: new challenges at the advent of the 'single device era'.

The ever-changing field of mechanical circulatory support: new challenges at the advent of the 'single device era'.

STS INTERMACS Database: The Key to Conduct Single-Arm Trials in Advanced Heart Failure Patients

BackgroundSafe introduction of novel mechanical circulatory support (MCS) devices into clinical practice is a challenging process. Single-arm trials using a control arm from existing database is an effective alternative that could be applied for regulatory approval. This study analyzes the capability of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database to establish objective performance criteria and select patient population that could be used for future single-arm MCS trials. MethodsPatients with INTERMACS profiles IM1-2 and IM3-5, who underwent implantation of isolated left ventricular assist devices between 2014 and 2017, were included. Both cohorts were further stratified into shock and nonshock groups using surrogate markers of shock (extracorporeal membrane oxygenation, temporary ventricular assist device, vasopressor infusions). Survival, transplantation rates, adverse events, 6-minute walk test, and quality-of-life measures were obtained for all 4 groups at 6 and 12 months. ResultsTotal of 7907 patients were divided into IM1-2 (n = 3909), IM3-5 (n = 3998), shock (n = 3469), and nonshock (n = 3040) groups. Recategorization occurred in 11% of patients from the IM3-5 group into the shock group. Overall, patients in the shock group had similar outcomes to the IM1-2 group (1-year survival: 86% vs 85%; P = .74). Patients in the nonshock group also had similar outcomes to the IM3-5 (1-year survival: 90% vs 90%; P = .43). ConclusionsThe INTERMACS database can successfully establish objective performance criteria and concurrent control group for single-arm trials that could be used to support regulatory approval of new, less invasive MCS. INTERMACS data allow reliable comparisons of outcomes and adverse events.

Less invasive surgical implant strategy and right heart failure after LVAD implantation

Conventional median sternotomy (CMS) is still the standard technique utilized to implant left ventricular assist devices (LVADs). Recent studies suggest that less invasive surgery (LIS) may be beneficial; however, robust data on differences in right heart failure (RHF) are lacking. This study aimed to determine the impact of LIS compared with that of CMS on RHF outcomes after LVAD implantation. An international multicenter retrospective cohort study was conducted across 5 centers. Patients were grouped according to their implantation technique (LIS vs CMS). Only centrifugal devices were included. RHF was defined as severe or severe acute RHF according to the 2013 Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) definition. Logistic multivariate regression and propensity score‒matched analyses were performed to account for confounding. Overall, 427 implantations occurred during the study period, with 305 patients implanted using CMS and 122 using LIS. Pre-operative extracorporeal membrane oxygenation (ECMO) and intra-aortic balloon pump (IABP) use was more common in the CMS group; off-pump implantation was more common in the LIS group. Other pre-implant variables, including age, creatinine, hemodynamics, and tricuspid regurgitation, did not differ between the 2 groups. Post-operative RHF was less common in the patients who underwent LIS than in those who underwent CMS as was post-operative right ventricular assist device (RVAD) use. LIS remained associated with less RHF in the multivariate analysis. After propensity score matching conditional for age, sex, INTERMACS profile, ECMO, and IABP use in a ratio of 2:1 (CMS to LIS), RHF (29.9% vs 18.6%, p = 0.001) and the need for post-operative RVAD (18.6% vs 8.2%; p = 0.009) remained more common in the CMS group than in the LIS group. There were no significant differences in survival up to 1 year between the groups. LIS may be associated with less RHF after LVAD implantation compared with CMS. Despite the possible reduction in RHF, there was no difference in 1-year survival. LIS is an alternative to traditional CMS.

Ambulatory advanced heart failure patients: timing of mechanical circulatory support - delaying the inevitable?

Current indications for continuous-flow left ventricular assist device (cfLVAD) implantation is for patients in cardiogenic shock or inotrope-dependent advanced heart failure. Risk stratification of noninotrope dependent ambulatory advanced heart failure patients is a subject of registries designed to help shared-decision making by clinicians and patients regarding the optimal timing of mechanical circulatory support (MCS). The Registry Evaluation of Vital Information for VADs in Ambulatory Life enrolled ambulatory noninotrope dependent advanced systolic heart failure patients who had 25% annualized risk of death, MCS, or heart transplantation (HT). Freedom from composite clinical outcome at 1-year follow-up was 23.5% for the entire cohort. Seattle Heart Failure Model Score and Natriuretic pepides were predictors with modest discriminatory power. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 4 patients had the highest risk (3.7-fold) of death, MCS or HT compared to INTERMACS profile 7. We propose individualized risk stratification for noninotrope dependent ambulatory advanced heart failure patients and include serial changes in end-organ function, nutritional parameters, frailty assessment, echocardiographic and hemodynamic data. The clinical journey of a patient with advanced heart failure should be tracked and discussed at each clinic visit for shared decision-making regarding timing of cfLVAD.

Abstract 15821: Patients With Amyloid Cardiomyopathy Who Receive Durable Mechanical Circulatory Support Are at Increased Risk for Mortality and Early Adverse Events

Introduction: Amyloid cardiomyopathy (ACM) is recognized increasingly as a cause of advanced heart failure. There are limited data describing clinical outcomes for ACM patients who receive durable mechanical circulatory support (MCS). Methods: This analysis included adult patients in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) with a primary diagnosis of dilated cardiomyopathy (DCM, N=19,921), non-amyloid restrictive cardiomyopathy (RCM, N=248), or ACM (N=48) who received durable MCS of any type or strategy from 2005-2017. We compared baseline characteristics and adverse events for the 3 groups. The primary endpoint was death with heart transplantation as a competing risk with follow-up censored at device explantation. Results: Patients with ACM (N=48) were older (61 y [IQR 55-69] versus 58 y [IQR 49-66] for DCM and 55 y [IQR 46-62] for non-amyloid RCM, P&lt;0.001), and more likely to be male (85% versus 79% for DCM and 63% for non-amyloid RCM, P&lt;0.001) and INTERMACS profile 1 (30% versus 18% for DCM and 21% for non-amyloid RCM, P=0.04) at implant. Use of biventricular support (concomitant left and right ventricular assist devices or total artificial heart) was highest in the ACM group (41% versus 7% and 19% for DCM and non-amyloid RCM groups, respectively, P&lt;0.001). ACM patients experienced a higher frequency of major bleeding (48% versus 29% for DCM and 34% for non-amyloid RCM, P=0.005), neurologic dysfunction (22% versus 10% for DCM and 14% for non-amyloid RCM, P=0.006), and renal dysfunction (20% versus 10% for DCM and 17% for non-amyloid RCM, P&lt;0.001) within 3 months. Risk of death at a median follow-up of 1 year was highest for the ACM group compared to DCM and non-amyloid RCM (Log-rank, P=0.014). Conclusion: Compared to DCM or non-amyloid RCM patients, those with durable MCS for ACM have the highest risk of early adverse events and lowest survival. These data highlight concerns with durable MCS for ACM.

Dynamic Forecasts of Survival for Patients Living With Destination Left Ventricular Assist Devices: Insights From INTERMACS.

BackgroundLeft ventricular assist devices (LVADs) improve outcomes in patients with end‐stage heart failure and are increasingly implanted for destination therapy. We describe dynamic estimates of event‐free survival with conditional survival probabilities in a destination therapy LVAD population.Methods and ResultsWe studied 8245 adult patients in INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) implanted with a continuous‐flow destination therapy LVAD. The composite primary end point was death, device exchange or removal, or heart transplantation. Conditional survival probabilities were calculated and stratified by implantation characteristics and nonfatal adverse events experienced within the first year after implant. Probabilities of surviving an additional 1 to 3 years were numerically higher after longer prior event‐free survival. INTERMACS profile 1, extracorporeal membrane oxygenation support, prior or concomitant surgery, and dialysis within 48 hours of implantation were associated with significantly lower event‐free survival in the first year but did not impact event‐free survival beyond then. For patients who experienced a nonfatal adverse event within the first year, subsequent 1‐year conditional survival was lower than in the absence of that event for stroke (65% [95% CI, 57%–73%] versus 75% [95% CI, 73%–77%]; P<0.001), device‐related infection (64% [95% CI 57%–71%] versus 76% [95% CI, 74%–78%]; P<0.001), and pump thrombosis or malfunction (64% [95% CI, 57%–70%] versus 76% [95% CI, 74%–78%]; P<0.001).ConclusionsConditional survival in patients with destination therapy LVADs improves over time, even for patients with unfavorable implantation characteristics. However, LVAD‐related complications including stroke, device‐related infection, and pump thrombosis or malfunction have an enduring negative influence on dynamic estimates of long‐term prognosis.

Longitudinal impact of temporary mechanical circulatory support on durable ventricular assist device outcomes: An IMACS registry propensity matched analysis

Patients with advanced heart failure and cardiogenic shock (CS) often require temporary circulatory support (TCS) as a bridge to durable ventricular assist devices (dVADs). We aim to characterize longitudinal outcomes of patients with and without CS. Between 2013 and 2017, 13,813 adult patients classified as Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profiles 1 to 3 with continuous flow left ventricular assist devices or biventricular assist devices were registered into the International Society for Heart and Lung Transplantation Registry for Mechanically Assisted Circulatory Support. Patients were sub-grouped according to support type (extracorporeal membrane oxygenation [ECMO], intra-aortic balloon pump [IABP], and other TCS). Other TCS included all other surgical and percutaneous TCS devices. Estimated survival was compared based on need for pre-operative TCS and by profile. Pre-operative TCS was used in 5,632 (41%) cases. Of these, ECMO was used in 1,138 (20%) cases, IABP in 3,901 (69%) cases, and other TCS in 595 (11%) cases. Patients requiring ECMO had greater needs for biventricular support after dVAD (22% ECMO, 5% IABP, and 7% other TCS; p < 0.001) with longer post-implant intensive care stays (ECMO 24 days, IABP 14 days, and other TCS 12 days; p < 0.001).INTERMACS Profile 1 to 3 patients with pre-implant ECMO had the lowest longitudinal survival (82% at 1 month and 44% at 48 months) compared with IABP (93% at 1 month and 51% at 48 months), other TCS (92% at 1 month and 52% at 48 months), and non-TCS (95% at 1 months and 55 % at 48 months) (p < 0.0001). Propensity score matching analysis of the pre-implant ECMO INTERMACS Profile 1 group when compared with alternative pre-implant TCS strategies had an associated higher hazard impacting early phase survival vs other TCS (hazard ratio, 1.80; p < 0.01) and IABP (hazard ratio, 1.65; p < 0.01). In advanced heart failure with patients with CS, the use of ECMO before dVAD was associated with lower longitudinal survival and increased utilization of biventricular support compared with alternative TCS strategies. Research focused on longitudinal profiling in CS and pre-implant TCS is warranted to further understand these differences.

INTERMACS profiles and outcomes of ambulatory advanced heart failure patients: A report from the REVIVAL Registry

Ambulatory patients with advanced heart failure (HF) are often considered for advanced therapies, including durable mechanical circulatory support (MCS). The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profiles are a commonly used descriptor of disease severity in patients receiving MCS devices, but their role in defining the prognosis of ambulatory patients is less well established, especially for Profiles 6 and 7. Registry Evaluation of Vital Information on Ventricular Assist Devices in Ambulatory Life is a prospective observational study of 400 outpatients from 21 MCS and cardiac transplant centers. Eligible patients had New York Heart Association Class II to IV symptoms despite optimal medical and electrical therapies with a recent HF hospitalization, heart transplant listing, or evidence of high neurohormonal activation. The cohort included 33 INTERMACS Profile 4 (8%), 83 Profile 5 (21%), 155 Profile 6 (39%), and 129 Profile 7 (32%). Across INTERMACS profiles, there were no differences in age, gender, ejection fraction, blood pressure, or use of guideline-directed medical therapy. A lower INTERMACS profile was associated with more hospitalizations, greater frailty, and more impaired functional capacity and quality of life. The composite end point of death, durable MCS, or urgent transplant at 12 months occurred in 39%, 27%, 24%, and 14% subjects with INTERMACS Profiles 4, 5, 6, and 7, respectively (p = 0.004). Among ambulatory patients with advanced HF, a lower INTERMACS profile was associated with a greater burden of HF across multiple dimensions and a higher composite risk of durable MCS, urgent transplant, or death. These profiles may assist in risk assessment and triaging ambulatory patients to advanced therapies.

Functional Recovery Post Left Ventricular Assist Device Implantation in INTERMACS Profile 1 Population

Purpose Left ventricular assist device (LVAD) have been demonstrated to improve functional capacity as measured by 6-minute walk test (6MWT) in patients with advanced heart failure. However, studies have not investigated functional recovery in patients with different Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile. Methods We conducted a retrospective review to assess the impact of LVAD therapy on functional recovery in 59 patients who underwent continuous-flow LVAD implantation as bridge to transplant or destination therapy, from 5 May 2009 to 9 February 2018, with minimum LVAD support of 90 days and a follow-up of at least 6 months. The third and sixth month 6MWT was performed following LVAD implant. Results There were 49 males and 10 females, age range 14 to 70 years (mean age 49). Based on the INTERMACS profile, there were 8.4% (5) at profile 4, 20% (12) at profile 2 while the majority was at profile 1 and 3 at 34% (20) and 37% (22) respectively. 55.5% from INTERMACS profile 1 were unable to perform the 6MWT at one month post LVAD implant. The median 6MWT distance at third month across all INTERMACS profiles was 365m. At sixth month, the median 6MWT distance in profile 1 was 469m, 423m in profile 2, 390m in profile 3 and 375m in profile 4. Statistically, there was a significant improvement in 6MWT from the third to sixth month for profile 1 with the median distance difference of 92m (interquartile range=56.8-143.3m) as compared to profile 2 at 44m (interquartile range=30.5-54.3m), and profile 3 at 31.5m (interquartile range=13.8-96.5m) with p=0.007 and p=0.027 respectively. However, the comparison was not done between profile 1 and 4 due to the small cohort in profile 4. Conclusion In conclusion, this review showed that the 6MWT for patients in INTERMACS profile 1, the high risk population, might be similar at third month in comparison to other profiles but it has demonstrated the most significant improvement in functional recovery at sixth month post LVAD implant with the survival rate of 100% at year 1.

Right ventricular free wall longitudinal strain and stroke work index for predicting right heart failure after left ventricular assist device therapy.

Right heart failure (RHF) is an important prognostic factor in continuous-flow left ventricular assist device (LVAD) therapy. We aimed to assess the clinical variables associated with RHF after LVAD implantation and to compare their performance against currently available RHF predictive scoring systems. The study cohort comprised 57 patients who underwent LVAD therapy between January 2012 and May 2018 in our centre. The mean age of the patients was 39.9 ± 18.3 years, and 43 (81.1%) of them were men. Thirty-eight patients (66.6%) were in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile I or II. The study cohort was divided into the patients with RHF postoperatively (n = 20, 35.1%) and without RHF (n = 37, 64.9%). Independent predictors for RHF were preoperative right ventricular ejection fraction <25% [odds ratio (OR) 4.68, 95% confidence interval (CI) 1.41-15.5; P = 0.01], right ventricular stroke work index <400 mmHg ml-1 (OR 3.73, 95% CI 1.01-13.7; P = 0.04), right ventricular outflow tract systolic excursion <7 mm (OR 1.55, 95% CI 0.31-0.84; P = 0.002), right ventricular outflow tract fractional shortening <15% (OR 1.62, 95% CI 0.34-0.78; P = 0.02), right ventricular free wall longitudinal strain ≤19% (OR 3.13, 95% CI 1.01-2.43; P = 0.003), right ventricular fractional area change <27% (OR 3.71, 95% CI 1.15-11.9; P = 0.02) and prealbumin <14 mg/dl (OR 3.45, 95% CI 1.07-11.03; P = 0.03). Modest diagnostic performance for RHF was detected in 4 of 7 validated scoring systems with resulting area under the curve values of 0.70 (95% CI 0.55-0.84; P = 0.001) for the Seattle Heart Failure Model; 0.68 (95% CI 0.49-0.81, P = 0.03) for the Fitzpatrick's; 0.68 (95% CI 0.53-0.83, P = 0.028) for the acute physiology and chronic health evaluation (APACHE) II; and 0.66 (95% CI 0.50-0.82, P = 0.04) for the model for end-stage liver disease scoring systems. However, we found best discrimination performance of the score with a resulting area under the curve value of 0.94 (95% CI 0.55-0.89, P = 0.03) for right ventricular free wall longitudinal strain ≥-15.5% and 0.82 for right ventricular stroke work index <400 mmHg ml-1 m-2 in predicting RHF. Right ventricular free wall longitudinal strain ≥-15.5% and right ventricular stroke work index <400 mmHg ml-1 m-2 were independent predictors of RHF following LVAD implantation. Currently available prediction risk scores had the modest power of accuracy in the low INTERMACS profile Turkish population.

Outcomes with ambulatory advanced heart failure from the Medical Arm of Mechanically Assisted Circulatory Support (MedaMACS) Registry.

The outlook for ambulatory patients with advanced heart failure (HF) and the appropriate timing for left ventricular assist device (LVAD) or transplant remain uncertain. The aim of this study was to better understand disease trajectory and rates of progression to subsequent LVAD therapy and transplant in ambulatory advanced HF. Patients with advanced HF who were New York Heart Association (NYHA) Class III or IV and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profiles 4 to 7, despite optimal medical therapy (without inotropic therapy), were enrolled across 11 centers and followed for the end-points of survival, transplantation, LVAD placement, and health-related quality of life. A secondary intention-to-treat survival analysis compared outcomes for MedaMACS patients with a matched group of Profile 4 to 7 patients with LVADs from the INTERMACS registry. Between May 2013 and October 2015, 161 patients were enrolled with INTERMACS Profiles 4 (12%), 5 (32%), 6 (49%), and 7 (7%). By 2 years after enrollment, 75 (47%) patients had reached a primary end-point with 39 (24%) deaths, 17 (11%) undergoing LVAD implantation, and 19 (12%) receiving a transplant. Compared with 1,753 patients with Profiles 4 to 7 receiving LVAD therapy, there was no overall difference in intention-to-treat survival between medical and LVAD therapy, but survival with LVAD therapy was superior to medical therapy among Profile 4 and 5 patients (p = 0.0092). Baseline health-related quality of life was lower among patients receiving a LVAD than those enrolled on continuing oral medical therapy, but increased after 1 year for survivors in both cohorts. Ambulatory patients with advanced HF are at high risk for poor outcomes, with only 53% alive on medical therapy after 2 years of follow-up. Survival was similar for medical and LVAD therapy in the overall cohort, which included the lower severity Profiles 6 and 7, but survival was better with LVAD therapy among patients in Profiles 4 and 5. Given the poor outcomes in this group of advanced HF patients, timely consideration of transplant and LVAD is of critical importance.

INTERMACS Profiles and Outcomes Among Non–Inotrope-Dependent Outpatients With Heart Failure and Reduced Ejection Fraction

ObjectivesThis study sought to evaluate INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profiles for prognostic use among ambulatory non–inotrope-dependent patients with heart failure with reduced ejection fraction (HFrEF). BackgroundData for INTERMACS profiles and prognoses in ambulatory patients with HFrEF are limited. MethodsWe evaluated 3-year outcomes in 969 non–inotrope-dependent outpatients with HFrEF (EF: ≤40%) not previously receiving advanced HF therapies. Patients meeting an INTERMACS profile at baseline were classified as profile 7 (n = 348 [34.7%]); 146 patients (14.5%) were classified profile 6; and 52 patients (5.2%) were classified profile 4 to 5. Remaining patients were classified “stable Stage C” (n = 423 [42.1%]). ResultsThree-year mortality rate was 10.0% among stable Stage C patients compared with 21.8% among INTERMACS profile 7 (hazard ratio [HR] vs. Stage C: 2.45; 95% confidence interval [CI]: 1.64 to 3.66), 26.0% among profile 6 (HR: 3.93; 95% CI: 1.64 to 3.66), and 43.8% among profile 4 to 5 (HR: 6.35; 95% CI: 3.51 to 11.5) patients. Hospitalization rates for HF were 4-fold higher among INTERMACS profile 7 (38 per 100 patient-years; rate ratio [RR] vs. Stage C: 3.88; 95% CI: 2.70 to 5.35), 6-fold higher among profile 6 patients (54 per 100 patient-years; RR: 5.69; 95% CI: 3.72 to 8.71), and 10-fold higher among profile 4 to 5 patients (69 per 100 patient-years; RR: 9.96; 95% CI: 5.15 to 19.3) than stable Stage C patients (11 per 100 patient-years). All-cause hospitalization rates had similar trends. INTERMACS profiles offered better prognostic separation than NYHA functional classifications. ConclusionsINTERMACS profiles strongly predict subsequent mortality and hospitalization burden in non–inotrope-dependent outpatients with HFrEF. These simple profiles could therefore facilitate and promote advanced HF awareness among clinicians and planning for advanced HF therapies.