Variability in Blood Pressure Assessment in Patients Supported with the HeartMate 3TM.

Targeted blood pressure (BP) control is a goal of left ventricular assist device medical management, but the interpretation of values obtained from noninvasive instruments is challenging. In the MOMENTUM 3 Continued Access Protocol, paired BP values in HeartMate 3 (HM3) patients were compared from arterial (A)-line and Doppler opening pressure (DOP) (319 readings in 261 patients) and A-line and automated cuff (281 readings in 247 patients). Pearson (R) correlations between A-line mean arterial (MAP) and systolic blood pressures (SBP) were compared with DOP and cuff measures according to the presence (>1 pulse in 5 seconds) or absence of a palpable radial pulse. There were only moderate correlations between A-line and noninvasive measurements of SBP (DOP R = 0.58; cuff R = 0.47) and MAP (DOP R = 0.48; cuff R = 0.37). DOP accuracy for MAP estimation, defined as the % of readings within ± 10 mmHg of A-line MAP, decreased from 80% to 33% for DOP ≤ 90 vs. >90 mmHg, and precision also diminished (mean absolute difference [MAD] increased from 6.3 ± 5.6 to 16.1 ± 11.4 mmHg). Across pulse pressures, cuff MAPs were within ±10 mmHg of A-line 62.9%-68.8% of measures and MADs were negligible. The presence of a palpable pulse reduced the accuracy and precision of the DOP-MAP estimation but did not impact cuff-MAP accuracy or precision. In summary, DOP may overestimate MAP in some patients on HM3 support. Simultaneous use of DOP and automated cuff and radial pulse may be needed to guide antihypertensive medication titration in outpatients on HM3 support.

Advances in the Management of Acute Decompensated Heart Failure.

Patients hospitalized for heart failure pose a considerable clinical and financial burden on the health care system. Early recognition and deep phenotyping of heart failure for reduced and preserved ejection fraction syndromes facilitate the introduction of appropriate guideline-directed therapy and decongestion strategies to help improve heart failure morbidity and mortality. Robust and safe transitions of care programs are needed to deliver adequate care and improve overall survival.

Impact on Readmission Reduction Among Heart Failure Patients Using Digital Health Monitoring: Feasibility and Adoptability Study.

BACKGROUND: Heart failure (HF) is a condition that affects approximately 6.2 million people in the United States and has a 5-year mortality rate of approximately 42%. With the prevalence expected to exceed 8 million cases by 2030, projections estimate that total annual HF costs will increase to nearly US $70 billion. Recently, the advent of remote monitoring technology has significantly broadened the scope of the physician's reach in chronic disease management. OBJECTIVE: The goal of our program, named the Heart Health Program, was to examine the feasibility of using digital health monitoring in real-world home settings, ascertain patient adoption, and evaluate impact on 30-day readmission rate. METHODS: A digital medicine software platform developed at Mount Sinai Health System, called RxUniverse, was used to prescribe a digital care pathway including the HealthPROMISE digital therapeutic and iHealth mobile apps to patients' personal smartphones. Vital sign data, including blood pressure (BP) and weight, were collected through an ambulatory remote monitoring system that comprised a mobile app and complementary consumer-grade Bluetooth-connected smart devices (BP cuff and digital scale) that send data to the provider care teams. Care teams were alerted via a Web-based dashboard of abnormal patient BP and weight change readings, and further action was taken at the clinicians' discretion. We used statistical analyses to determine risk factors associated with 30-day all-cause readmission. RESULTS: Overall, the Heart Health Program included 58 patients admitted to the Mount Sinai Hospital for HF. The 30-day hospital readmission rate was 10% (6/58), compared with the national readmission rates of approximately 25% and the Mount Sinai Hospital's average of approximately 23%. Single marital status (P=.06) and history of percutaneous coronary intervention (P=.08) were associated with readmission. Readmitted patients were also less likely to have been previously prescribed angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers (P=.02). Notably, readmitted patients utilized the BP and weight monitors less than nonreadmitted patients, and patients aged younger than 70 years used the monitors more frequently on average than those aged over 70 years, though these trends did not reach statistical significance. The percentage of the 58 patients using the monitors at least once dropped from 83% (42/58) in the first week after discharge to 46% (23/58) in the fourth week. CONCLUSIONS: Given the increasing burden of HF, there is a need for an effective and sustainable remote monitoring system for HF patients following hospital discharge. We identified clinical and social factors as well as remote monitoring usage trends that identify targetable patient populations that could benefit most from integration of daily remote monitoring. In addition, we demonstrated that interventions driven by real-time vital sign data may greatly aid in reducing hospital readmissions and costs while improving patient outcomes.

Standardized Use of the Stanford Integrated Psychosocial Assessment for Transplantation in LVAD Patients.

BACKGROUND: Increased psychosocial risk portends poor outcomes following heart transplantation. The Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT) is a validated, psychosocial risk assessment tool that helps stratify candidates for transplantation. We assessed the impact of psychosocial factors as measured by the SIPAT on clinical outcomes following left ventricular assist device (LVAD) implantation at our institution. METHODS AND RESULTS: A total of 115 individuals (mean age: 57 years, 75.6% men) who underwent LVAD implantation, for either bridge-to-transplant (63%) or destination therapy, from 2014 to 2016 were included for analysis. Correlations between SIPAT scores, baseline characteristics, and post-LVAD outcomes were assessed through a retrospective correlational design. At 1 year post-LVAD, the higher risk SIPAT group had more emergency department visits, urgent clinic visits, and readmissions in univariate analysis (rate ratio 1.7 [95% confidence interval (CI) 1.0-2.7, P = .035]). After multivariate analysis, this association retained near-statistical significance (rate ratio 1.6 [95% CI 1.0-2.8, P = .051]). There was also a trend toward more device-associated infections (rate ratio 2.1 [95% CI 0.96-4.4, P = .064]). There was no difference in incidence of other adverse events or 1-year mortality between the 2 groups. CONCLUSIONS: Higher psychosocial risk per SIPAT in patients undergoing LVAD implantation is associated with more emergency room visits, urgent visits and readmissions over 1 year, but not LVAD-related complications or mortality. Use of the SIPAT tool may help identify patients at higher risk for hospitalization and/or urgent care beyond traditional factors, but should not preclude LVAD implantation.

Gene expression profiling and racial disparities in outcomes after heart transplantation.

BACKGROUND: African Americans (AAs) have lower survival rates after heart transplantation (HTx) than Caucasians. The aim of this analysis was to evaluate racial differences in gene expression and their associations with survival and the composite outcome of death, retransplant, rejection with hemodynamic compromise, and graft dysfunction in the Outcomes AlloMap Registry. METHODS: Registry participants included low-risk Caucasian and AA heart transplant recipients with a baseline and at least 1 follow-up gene expression test (AlloMap(C)) within the first year after HTx. The Kaplan-Meier method with delayed entry was used to describe differences in outcomes. Multivariable Cox hazard regression was used to evaluate the associations of overall gene expression profiling score, MARCH8 and FLT3 expression, and tacrolimus levels with each outcome, and stratified Cox models were developed to quantify race-specific associations. RESULTS: Among 933 eligible recipients, 737 (79%) were Caucasian and 196 (21%) were AA. Compared with Caucasians, AAs were significantly younger (55 vs 59 years, p < 0.001), with higher rates of non-ischemic cardiomyopathy (68% vs 50%, p < 0.001), sensitization (>10% panel reactive antibody, 16% vs 9.1%, p = 0.009), and human leukocyte antigen mismatches (7 vs 7, p = 0.01), but less frequent primary cytomegalovirus serostatus mismatch (14.31% vs 27.3%, p < 0.001). Overall, AAs had an increased adjusted mortality risk (hazard ratio [HR] 4.13, p = 0.007). Higher tacrolimus levels were associated with decreased mortality in AAs (HR 0.62, p = 0.009). Overall gene expression profiling score was associated with increased mortality among Caucasians (HR 1.21, p = 0.048). In Caucasians, but not AAs, overexpression of MARCH8 was associated with increased mortality (HR 2.90, p = 0.001). FLT3 upregulation was associated with increased mortality (HR 2.42, p = 0.033) in AAs. There was an inverse relationship between FLT3 expression and tacrolimus levels (-0.029 and -0.176, respectively) in Caucasians and AAs. CONCLUSIONS: AAs have a significantly higher mortality risk after HTx than Caucasians, even in the low-risk Outcomes AlloMap Registry population. AAs and Caucasians had differential outcomes based upon the varying expression of MARCH8 and FLT3 genes following HTx.

Report from the American Society of Transplantation on frailty in solid organ transplantation.

A consensus conference on frailty in kidney, liver, heart, and lung transplantation sponsored by the American Society of Transplantation (AST) and endorsed by the American Society of Nephrology (ASN), the American Society of Transplant Surgeons (ASTS), and the Canadian Society of Transplantation (CST) took place on February 11, 2018 in Phoenix, Arizona. Input from the transplant community through scheduled conference calls enabled wide discussion of current concepts in frailty, exploration of best practices for frailty risk assessment of transplant candidates and for management after transplant, and development of ideas for future research. A current understanding of frailty was compiled by each of the solid organ groups and is presented in this paper. Frailty is a common entity in patients with end-stage organ disease who are awaiting organ transplantation, and affects mortality on the waitlist and in the posttransplant period. The optimal methods by which frailty should be measured in each organ group are yet to be determined, but studies are underway. Interventions to reverse frailty vary among organ groups and appear promising. This conference achieved its intent to highlight the importance of frailty in organ transplantation and to plant the seeds for further discussion and research in this field.

Healthcare Resource Use and Cost Implications in the MOMENTUM 3 Long-Term Outcome Study.

BACKGROUND: The MOMENTUM 3 trial compares the centrifugal HeartMate 3 (HM3) with the axial HeartMate II (HMII) continuous-flow left ventricular assist system in patients with advanced heart failure, irrespective of the intended goal of therapy. The trial's 2-year clinical outcome (n=366) demonstrated superiority of the HM3 for the primary end point (survival free of a disabling stroke or reoperation to replace or remove a malfunctioning pump). This analysis evaluates health resource use and cost implications of the observed differences between the 2 devices while patients were enrolled in the trial. METHODS: We analyzed all hospitalizations and their associated costs occurring after discharge from the implant hospitalization until censoring (study withdrawal, heart transplantation, and pump exchange with a nonstudy device or death). Each adjudicated episode of hospital-based care was used to calculate costs (device-attributable and non-device-attributable event costs), estimated by using trial data and payer administrative claims databases. Cost savings stratified by subgroups (study outcome [transplant, death, or ongoing on device], intended goal of therapy, type of insurance, or sex) were also assessed. RESULTS: In 366 randomly assigned patients, 361 comprised the as-treated group (189 in the HM3 group and 172 in the HMII group), of whom 337 (177 in the HM3 group and 160 in the HMII group) were successfully discharged following implantation. The HM3 arm experienced fewer total hospitalizations per patient-year (HM3: 2.1±0.2 versus HMII: 2.7±0.2; P=0.015) and 8.3 fewer hospital days per patient-year on average (HM3: 17.1 days versus HMII: 25.5 days; P=0.003). These differences were driven by patients hospitalized for suspected pump thrombosis (HM3: 0.6% versus HMII: 12.5%; P<0.001) and stroke (HM3: 2.8% versus HMII: 11.3%; P=0.002). Controlled for time spent in the study (average cumulative cost per patient-year), postdischarge HM3 arm costs were 51% lower than with the HMII (HM3: $37 685±4251 versus HMII: $76 599±11 889, P<0.001) and similar in either bridge to transplant or destination therapy intent. CONCLUSIONS: In this 2-year outcome economic analysis of the MOMENTUM 3 trial, the HM3 demonstrated a reduction in rehospitalizations, hospital days spent during rehospitalizations, and a significant cost savings following discharge in comparison with the HMII left ventricular assist system, irrespective of the intended goal of therapy. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02224755.

Usefulness of Speckle Tracking Strain Echocardiography for Assessment of Risk of Ventricular Arrhythmias After Placement of a Left Ventricular Assist Device.

Patients with continuous-flow left ventricular assist devices (LVADs) are at elevated risk of developing ventricular arrhythmias (VA), which can result in right ventricular dysfunction and abnormal LVAD function. Predictors of postoperative VA after LVAD placement are unclear. We hypothesized that global left ventricular circumferential strain (LVCS), a marker of transmural impairment in myocardial function, would independently predict postoperative VA in patients who underwent LVAD implantation. We studied 98 consecutive patients (57 ± 11 years, 83% men) who underwent HeartMate II axial flow LVAD placement. Speckle tracking-derived global circumferential strain was assessed from mid-left ventricular short-axis images. The primary composite end point was defined as any ventricular tachycardia that required intervention (anti-arrhythmic medication, cardioversion, implantable cardioverter defibrillator placement, implantable cardioverter defibrillator shock) or any ventricular fibrillation. A total of 33 patients (34%) experienced the primary end point (median follow-up: 7 months). Reduced LVCS was statistically significantly related to the primary end point (hazard ratio 1.77, 95% confidence interval 1.09 to 2.87 per 1 standard deviation reduction in LVCS, p = 0.02). LVCS above a cut-off value of -9.7% was associated with significantly reduced arrhythmia-free survival (log-rank p = 0.001). In conclusion, global LVCS is an independent predictor of ventricular arrhythmias after LVAD placement.

Maximizing donor allocation: A review of UNOS region 9 donor heart turn-downs.

This study was performed to determine if organ selection practices for heart utilization by Region 9 transplant programs were optimal, and to identify opportunities to increase local organ recovery. A retrospective review of de-identified region-wide donor data January 1, 2010 through December 31, 2013 was performed. Over the study period 537 heart donors were identified, of which 321 (60%) were transplanted. Two hundred-sixteen consented hearts were not used; 190 of these were not recovered, and 26 were recovered but not transplanted. Of these, 245/321 (76%) hearts were transplanted at one of 5 regional programs, 15 (5%) were transplanted out of region as primary offers, and 61 (19%) were turned down in region and exported. Of the 61 exported hearts, 43 were turned down in region for donor-related "quality" codes (UNOS 830, 833-837) by at least one program, the remaining 18 hearts were turned down for non-"quality" reasons, primarily histocompatibility and size. Only 5/43 exported were turned down for "quality" reasons by all regional programs offered the organ. A review of consented, not recovered donor offers suggested an additional 28 organs were possibly appropriate for transplant. Our review of regional turn-downs suggests transplant centers could potentially identify additional usable organs without compromising short-term outcomes.

The Relationship Between Psychological Symptoms and Ventricular Assist Device Implantation.

CONTEXT: Ventricular assist devices (VADs) improve quality of life in advanced heart failure patients, but there are little data exploring psychological symptoms in this population. OBJECTIVE: This study examined the prevalence of psychiatric symptoms and disease over time in VAD patients. METHODS: This prospective multicenter cohort study enrolled patients immediately before or after VAD implant and followed them up to 48 weeks. Depression and anxiety were assessed with Patient-Reported Outcomes Measurement Information System Short Form 8a questionnaires. The panic disorder, acute stress disorder (ASD) and post-traumatic stress disorder (PTSD) modules of the Structured Clinical Interview for the DSM were used. RESULTS: Eighty-seven patients were enrolled. After implant, depression and anxiety scores decreased significantly over time (P = 0.03 and P < 0.001, respectively). Two patients met criteria for panic disorder early after implantation, but symptoms resolved over time. None met criteria for ASD or PTSD. CONCLUSIONS: Our study suggests VADs do not cause serious psychological harms and may have a positive impact on depression and anxiety. Furthermore, VADs did not induce PTSD, panic disorder, or ASD in this cohort.

Left Ventricular Assist Devices for Lifelong Support.

Continuous-flow left ventricular assist devices (LVADs) have revolutionized advanced heart failure care. These compact, fully implantable heart pumps are capable of providing meaningful increases in survival, functional capacity, and quality of life. Implantation volumes continue to grow, but several challenges remain to be overcome before LVADs will be considered as the therapy of choice for all patients with advanced heart failure. They must be able to consistently extend survival for the long term (7 to 10 years), rather than the midterm (3 to 5 years) more typical of contemporary devices; they must incorporate design elements that reduce shear stress and avoid stasis to reduce the frequent adverse events of bleeding, stroke, and pump thrombosis; and they must become more cost-effective. The advancements in engineering, implantation technique, and medical management detailed in this review will highlight the progress made toward achieving lifelong LVAD support and the challenges that remain.