Search

Continuous-flow left ventricular assist device (CF-LVAD) support is a mainstay in the hemodynamic management of patients with end-stage heart failure refractory to optimal medical therapy. In this report we evaluated waitlist complications and competing outcomes for CF-LVAD patients compared with primary transplant candidates listed for orthotopic heart transplantation at a single center. All patients listed for orthotopic heart transplantation between 2006 and 2020 at our institution were retrospectively reviewed (CF-LVAD, 300; primary transplant, 244). Kaplan-Meier methodology with log-rank testing was used to evaluate survival outcomes. Terminal outcomes of death, delisting, and transplant were assessed as competing risks and compared between groups using Gray's test. Multivariable Fine-Gray regression was used to identify predictors of transplantation. One-year rates of transplant, delisting, and death were 48%, 8%, and 2%, respectively, for CF-LVAD patients and 45%, 15%, and 9%, respectively, for primary transplant (all P <.001). Waitlist mortality at 5 years was 4% among CF-LVAD patients and 13% for primary transplants. All-cause mortality after listing was lower for CF-LVAD patients (P =.017). There was no difference in posttransplant survival between groups (P =.250). On multivariable Fine-Gray regression stroke (P =.017), respiratory failure (P =.032), right ventricular failure (P =.019), and driveline infection (P =.050) were associated with decreased probability of transplantation. Posttransplant survival was not significantly worse for CF-LVAD patients who experienced device-related complications (P =.901). Although device-related complications were significantly associated with decreased rates of transplant, CF-LVAD patients had excellent waitlist outcomes overall. In light of the 2018 allocation score change the risk of complications should be taken into account when deciding whether to offer CF-LVAD as a bridge to transplant. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: Bleeding is a common and costly complication of percutaneous coronary intervention (PCI). Bleeding avoidance strategies (BAS) are used paradoxically less in patients at high-risk of bleeding: "bleeding risk-treatment paradox" (RTP). We determined whether hospitals and physicians, who do not align BAS to PCI patients' bleeding risk (ie, exhibit a RTP) have higher bleeding rates.Methods: We examined 28,005 PCIs from the National Cardiovascular Data Registry CathPCI Registry for 7 hospitals comprising BJC HealthCare. BAS included transradial intervention, bivalirudin, and vascular closure devices. Patients' predicted bleeding risk was based on National Cardiovascular Data Registry CathPCI bleeding model and categorized as low (<2.0%), moderate (2.0%-6.4%), or high (≥6.5%) risk tertiles. BAS use was considered risk-concordant if: at least 1 BAS was used for moderate risk; 2 BAS were used for high risk and bivalirudin or vascular closure devices were not used for low risk. Absence of risk-concordant BAS use was defined as RTP. We analyzed inter-hospital and inter-physician variation in RTP, and the association of RTP with post-PCI bleeding.Results: Amongst 28,005 patients undergoing PCI by 103 physicians at 7 hospitals, RTP was observed in 12,035 (43%) patients. RTP was independently associated with a higher likelihood of bleeding even after adjusting for predicted bleeding risk, mortality risk and potential sources of variation (OR 1.66, 95% CI 1.44-1.92, P < .001). A higher prevalence of RTP strongly and independently correlated with worse bleeding rates, both at the physician-level (Wilk's Lambda 0.9502, F-value 17.21, P < .0001) and the hospital-level (Wilk's Lambda 0.9899, F-value 35.68, P < .0001). All the results were similar in a subset of PCIs conducted since 2015 - a period more reflective of the contemporary practice.Conclusions: Bleeding RTP is a strong, independent predictor of bleeding. It exists at the level of physicians and hospitals: those with a higher rate of RTP had worse bleeding rates. These findings not only underscore the importance of recognizing bleeding risk upfront and using BAS in a risk-aligned manner, but also inform and motivate national efforts to reduce PCI-related bleeding. [ABSTRACT FROM AUTHOR]

Survival after bridge to transplantation with mechanical circulatory support (MCS) has yielded varying outcomes on the basis of device type and baseline characteristics. Continuous-flow left ventricular assist devices (CF-LVADs) have significantly improved waitlist mortality, but recent changes to the transplantation listing criteria have dramatically altered the use of MCS for bridge to transplantation. Orthotopic heart transplantations from 1988 to 2019 at our institution (Washington University School of Medicine, Barnes-Jewish Hospital, St Louis, MO) were retrospectively reviewed and stratified by pretransplantation MCS status into CF-LVAD (n = 224), pulsatile LVAD (n = 49), temporary MCS (n = 71), and primary transplantation (n = 463) groups. Patients who underwent heart transplantation after the approval of CF-LVAD for bridge to transplantation and before the 2018 allocation policy changes underwent subgroup analysis to evaluate predictors of survival and complications in a contemporary cohort. Rates of primary transplantation declined from 88% to 14% over the course of the study. No significant difference in survival was detected in the cohort stratified by MCS status (P =.18). In the modern era, survival of patients treated with CF-LVADs and temporary MCS was noninferior to that seen with primary transplantation (P =.22). Notable predictors of long-term mortality included lower body mass index, peripheral vascular disease, previous coronary artery bypass graft, ABO nonidentical transplant, and increased donor age (all P ≤.02). There were no differences in major postoperative complications. CF-LVAD has grown to account for the majority of transplantations at our center in the last decade, with no adverse effect on survival or postoperative complications. Temporary MCS increased after the 2018 listing criteria change, with acceptable early outcomes. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: Ventricular assist devices provide improved outcomes for patients with advanced heart failure, but their benefit in the severely obese is not well documented.Methods: Patients enrolled in the HeartWare ADVANCE trial (n=382) were divided into 2 body mass index (BMI) groups. Patients with severe obesity (>35 kg/m2) were compared with a control group with BMI ≤35 kg/m2. The association of BMI with survival was tested using Kaplan-Meier analysis and major adverse events were compared.Results: At implantation, 48 (13%) of patients were severely obese. There was no difference in survival through 2 years of support between severely obese patients and the control group. Severely obese patients were at higher risk of driveline infection (P = .01) and acute renal dysfunction (P = .002). Both groups experienced similar improvements in quality of life. Functional capacity improved in both severely obese and control patients, although severely obese patients had smaller improvements than controls in their 6-minute walk scores.Conclusions: Despite an increased risk of adverse events, severe obesity was not associated with reduced survival or quality of life. A better understanding of the risks and benefits of left ventricular assist device therapy in obese patients will help in the shared decision-making of the patient selection process. [ABSTRACT FROM AUTHOR]

Background: After several neutral telehealth trials, the positive findings and subsequent Food and Drug Administration approval of an implantable pulmonary arterial pressure monitor (PAPM) led to renewed interest in remote patient monitoring (RPM). Here we seek to provide contemporary guidance on the appropriate use of RPM technology.Results: Although early trials of external RPM devices suggested benefit, subsequent multicenter trials failed to demonstrate improved outcomes. Monitoring features of cardiac implantable electronic devices (CIEDs) also did not deliver improved HF outcomes, newer, multisensor algorithms may be better. Earlier technologies using direct pressure measurement via implanted devices failed to show benefit owing to complications or failure. Recently, 1 PAPM showed benefit in a randomized controlled trial. Although not showing cost reduction, cost-benefit analysis of that device suggests that it may meet acceptable standards. Additional research is warranted and is in progress. Consumer-owned electronic devices are becoming more pervasive and hold hope for future benefit in HF management. Practical aspects around RPM technology include targeting of risk populations, having mechanisms to ensure patient adherence to monitoring, and health care team structures that act on the data.Conclusions: Based on available evidence, routine use of external RPM devices is not recommended. Implanted devices that monitor pulmonary arterial pressure and/or other parameters may be beneficial in selected patients or when used in structured programs, but the value of these devices in routine care requires further study. Future research is also warranted to better understand the cost-effectiveness of these devices. [ABSTRACT FROM AUTHOR]

Background Patients supported with extracorporeal life support (ECLS) can experience severe complications from increased left ventricular (LV) afterload. The Impella (Abiomed, Danvers, MA) percutaneous ventricular assist device (PVAD) may offer an attractive option for unloading the LV in these patients. This study describes the efficacy and outcomes of PVAD use during ECLS compared with surgically placed LV vent. Methods In this retrospective study, we reviewed patients supported by ECLS with PVAD or surgical LV vent for cardiogenic shock between April 2010 and May 2016. Included were 23 patients with PVADs and 22 with surgical vents. Patients’ baseline characteristics, hemodynamic data, and outcomes were collected immediately preceding combined support initiation, at 48 hours, intensive care unit discharge, and 30 days. Results After 48 hours, pulmonary artery diastolic pressure was significantly reduced in the PVAD (23.3 ± 8.4 vs 15.6 ± 4.2, p = 0.02) and surgical vent groups (20.1 ± 5.9 vs 15.6 ± 5.4, p = 0.01), and radiographic evidence of pulmonary edema was reduced or unchanged in 90% of PVAD patients and in 76% of surgical vent patients. The primary end points of survival to 30 days (43% vs 32%, p = 0.42) and intensive care unit discharge (35% vs 23%, p = 0.37) were not different between the two methods of support. The PVAD and surgical vent groups were also not significantly different in the rate of vascular complications or in the number decannulated from ECLS and transitioned to durable LV assist device. Conclusions PVAD use in ECLS patients is an effective means of LV unloading and preventing worsened pulmonary edema, with outcomes and complications that are comparable to surgical LV vent. [ABSTRACT FROM AUTHOR]

The presentation, natural history, clinical outcomes, and response to therapy in patients with heart failure differ in some ways across populations. Women, older adults, and non-Caucasian racial or ethnic groups compose a substantial proportion of the overall heart failure population, but they have typically been underrepresented in clinical trials. As a result, uncertainty exists about the efficacy of some guideline-directed medical therapies and devices in specific populations, which may result in the under- or overtreatment of these patients. Even when guideline-based treatments are prescribed, socioeconomic, physical, or psychologic factors may affect non-Caucasian and older adult patient groups to a different extent and affect the application, effectiveness, and tolerability of these therapies. Individualized therapy based on tailored biology (genetics, proteomics, metabolomics), socioeconomic and cultural considerations, and individual goals and preferences may be the optimal approach for managing diverse patients. This comprehensive approach to personalized medicine is evolving, but in the interim, the scientific community should continue efforts focused on intensifying research in special populations, prescribing guideline-directed medical therapy unless contraindicated, and implementing evidence-based strategies including patient and family education and multidisciplinary team care in the management of patients. [ABSTRACT FROM AUTHOR]

We propose that stage D advanced heart failure be defined as the presence of progressive and/or persistent severe signs and symptoms of heart failure despite optimized medical, surgical, and device therapy. Importantly, the progressive decline should be primarily driven by the heart failure syndrome. Formally defining advanced heart failure and specifying when medical and device therapies have failed is challenging, but signs and symptoms, hemodynamics, exercise testing, biomarkers, and risk prediction models are useful in this process. Identification of patients in stage D is a clinically important task because treatments are inherently limited, morbidity is typically progressive, and survival is often short. Age, frailty, and psychosocial issues affect both outcomes and selection of therapy for stage D patients. Heart transplant and mechanical circulatory support devices are potential treatment options in select patients. In addition to considering indications, contraindications, clinical status, and comorbidities, treatment selection for stage D patients involves incorporating the patient's wishes for survival versus quality of life, and palliative and hospice care should be integrated into care plans. More research is needed to determine optimal strategies for patient selection and medical decision making, with the ultimate goal of improving clinical and patient centered outcomes in patients with stage D heart failure. [ABSTRACT FROM AUTHOR]

Background We sought to determine if outcomes with exercise training in heart failure (HF) vary according to ventricular pacing type. Methods and Results Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) randomized 2,331 outpatients with HF and left ventricular ejection fraction ≤35% to usual care plus exercise training or usual care alone. We examined the relationship between outcomes and randomized treatment according to ventricular pacing status with the use of Cox proportional hazards modeling. In HF-ACTION 1,118 patients (48%) had an implanted cardiac rhythm device: 683 with right ventricular (RV) and 435 with biventricular (BiV) pacemakers. Patients with pacing devices were older, more frequently white, and had lower peak VO 2 ( P < .001 for all). Peak VO 2 improved similarly with training in groups with and without pacing devices. The primary composite end point—all-cause death or hospitalization—was reduced only in patients randomized to exercise training without a device (hazard ratio [HR] 0.79, 95% confidence interval [CI] 0.67–0.93 [ P = .004]; RV lead: HR 1.04, 95% CI 0.84–1.28 [ P = .74]; BiV pacing: HR 1.05, 95% CI 0.82–1.34 [ P = .72]; interaction P = .058). Conclusions Exercise training may improve exercise capacity in patients with implanted cardiac devices. However, the apparent beneficial effects of exercise on hospitalization or death may be attenuated in patients with implanted cardiac devices and requires further study. [ABSTRACT FROM AUTHOR]

Background: The purpose of this study is to comparatively analyze outcomes of heart transplant patients bridged to transplantation with HeartWare (HW-VAD) versus HeartMate II (HMII-VAD) left ventricular assist devices. Methods: The United Network for Organ Sharing Database was reviewed to identify first-time heart transplant recipients who were bridged to transplantation with either HW-VAD (n = 141) or HMII-VAD (n = 1824) from January 2009 through July 2012. Results: Recipients of HW-VAD had a higher proportion of female patients (27.0% versus 18.9%; p = 0.019), a lower body surface area (2.01 ± 0.25 m2 versus 2.06 ± 0.25 m2; p = 0.035), and a trend toward a higher peak percentage of panel reactive antibody against human leukocyte class I antigens (40.4% ± 32.8% versus 33.0% ± 30.4%; p = 0.070). Pretransplantation recipient cardiac index (2.33 ± 0.66 L ⋅ min−1 ⋅ m−2 versus 2.33 ± 0.68 L ⋅ min−1 ⋅ m−2), serum creatinine (1.21 ± 0.43 mg/dL versus 1.26 ± 0.57 mg/dL), and total bilirubin (1.34 ± 3.45 mg/dL versus 1.06 ± 1.84 mg/dL) were comparable between the two groups (p > 0.05 for all comparisons). After transplantation, there were no significant differences in freedom from rejection or freedom from cardiac allograft vasculopathy. Posttransplant graft survival rates were similar between the HW-VAD group and the HMII-VAD group at 1, 2, and 3 years (88.4% versus 87.8%, 79.9% versus 83.8%, and 77.4% versus 79.9%, respectively; p = 0.843). Conclusions: These findings suggest similar hemodynamic unloading, pretransplant end-organ function, and posttransplant outcomes in patients bridged to transplantation with both the HW-VAD and HMII-VAD. [Copyright &y& Elsevier]

Abstract: This is the first reported study of ventricular activation patterns after cardiac transplantation, using electrocardiographic imaging (ECGI), a noninvasive method for electrophysiologic mapping. This study of ten patients reveals that transplanted hearts have unique ventricular activation patterns in sinus rhythm, activating early in the epicardial aspect of the anterior or inferior septum, with intact right and left bundle branch conduction. They have late activation with slowing of conduction near the right ventricular (RV) basal free wall, causing a mild QRS prolongation and an rSr’ pattern in lead V1 of the ECG. PVCs arise from both endocardial and epicardial locations in both ventricles. [Copyright &y& Elsevier]

Background: Although several studies have examined factors affecting survival after orthotopic heart transplantation (OHT), few have evaluated the impact of reoperative sternotomy. We undertook this study to examine the incidence and impact of repeat sternotomies on OHT outcomes. Methods: We conducted a retrospective review of all adult OHT from 2 institutions. Primary stratification was by the number of prior sternotomies. The primary outcome was survival. Secondary outcomes included blood product utilization and commonly encountered postoperative complications. Multivariable Cox proportional hazards regression models examined mortality while linear regression models examined blood utilization. Results: From January 1995 to October 2011, 631 OHT were performed. Of these, 25 (4.0%) were redo OHT and 182 (28.8%) were bridged to transplant with a ventricular assist device; 356 (56.4%) had undergone at least 1 prior sternotomy. On unadjusted analysis, reoperative sternotomy was associated with decreased 90-day (98.5% vs 90.2%, p < 0.001), 1-year (93.1% vs 79.6%, p < 0.001), and 5-year (80.4% vs 70.1%, p = 0.002) survival. This difference persisted on multivariable analysis at 90 days (hazard ratio [HR] 2.99, p = 0.01), 1 year (HR 2.98, p = 0.002), and 5 years (HR 1.62, p = 0.049). The impact of an increasing number of prior sternotomies was negligible. On multivariable analysis, an increasing number of prior sternotomies was associated with increased intraoperative blood product utilization. Increasing blood utilization was associated with decreased 90-day, 1-year, and 5-year survival. Conclusions: Reoperative sternotomy is associated with increased mortality and blood utilization after OHT. Patients with more than 1 prior sternotomy do not experience additional increased mortality. Carefully selected patients with multiple prior sternotomies have decreased but acceptable outcomes. [ABSTRACT FROM AUTHOR]

Background: Left ventricular assist devices (LVADs) have revolutionized the management of end-stage heart failure (ESHF). However, unexpectedly high rates of GI bleeding (GIB) have been described, and etiology and outcome remain unclear. Objective: To determine the prevalence, etiology, and outcome of GIB in LVAD recipients. Design: Retrospective case series. Setting: Tertiary care academic university hospital. Patients: 154 ESHF patients (55.4 years, 122 men/32 women) with LVADs implanted over a 10-year period. Main outcome measurements: Overt or occult GIB prompting endoscopic evaluation ≥7 days after LVAD implantation. Results: Over a mean of 0.9 ± 0.1 years of follow-up, 29 patients (19%) experienced 44 GIB episodes. Patients with GIB were older and received anticoagulation therapy before devices were implanted (P ≤ .02 for each). GIB was overt (n = 31) rather than occult (n = 13), and most patients presented with melena (n = 22, 50%); hemodynamic instability was observed in 13.6%. Each bleeding episode required 2.1 ± 0.1 diagnostic or therapeutic procedures, and a source was localized in 71%. Upper endoscopy provided the highest diagnostic yield; peptic bleeding (n = 14) and vascular malformations (n = 8) dominated the findings. Endoscopy was safe and well tolerated. Overall mortality was 35%, none directly from GIB. Limitation: Retrospective design. Conclusions: Rates of GIB with LVADs are higher than that seen in other patient populations, including those receiving anticoagulation and antiplatelet therapy. GIB episodes are mostly overt and predominantly from the upper GI tract. Endoscopy is safe in the LVAD population. [Copyright &y& Elsevier]

Background: Continuous-flow left ventricular assist devices (LVAD) are increasingly being used in patients with end-stage heart failure and have largely replaced older generation pulsatile devices. While significant rates of infection have been reported in patients with pulsatile device support, incidence and outcomes of this complication for the continuous-flow device patients remain unknown. Methods: Between June 2005 and August 2009, 81 patients were implanted with continuous-flow LVADs at Washington University School of Medicine either as bridge to transplantation or as destination therapy. Outcomes of this study included incidence of postimplantation infection, types of infection, microbiologic profile, and association of postimplantation infections with clinical endpoints. Results: Forty-two patients (51.9%) had at least one type of infection on continuous-flow LVAD support with a mean follow-up period of 9.2 ± 9.2 months. Patients who had an infection on LVAD support had a significantly prolonged hospital stay (37.9 ± 32.0 versus 20.7 ± 23.0 days, p = 0.008) and a trend toward increased mortality (33.1% versus 18.7% at 2 years, respectively, log rank p = 0.102) compared with patients who did not. Subgroup analysis revealed that postimplantation sepsis was significantly associated with increased mortality in the continuous-flow LVAD cohort (61.9% versus 18.0% at 2 years, respectively, in septic and nonseptic patients, log rank p = 0.001). The majority of the sepsis cases occurred before hospital discharge, whereas most of the device related infections occurred after discharge. Resistant Staphylococcus and Pseudomonas species were the most common pathogens leading to device- and nondevice-related local infections. Development of driveline or pocket infection had no effect on survival in patients with continuous-flow assist device support (p = 0.193). Conclusions: Even though better clinical outcomes have been achieved with the newer generation continuous-flow devices, infection complications—in particular sepsis—are still a major risk for patients with continuous-flow LVAD implantation. Prevention strategies with aggressive medical and surgical management of infections may increase survival and decrease morbidity among continuous-flow LVAD patients. [Copyright &y& Elsevier]

Background: A successful left ventricular assist device (LVAD) long-term support in an outpatient setting demands that device-related complications are reduced to a minimum. We hypothesized that late onset driveline infections have serious implications on the anticipated application of LVAD as permanent therapy. Methods: Between 1996 and 2005, 73 patients were implanted with the Novacor (World Heart Corp, Ottawa, Ontario, Canada; n = 35) or the HeartMate (Thoratec Corp, Pleasanton, CA; n = 38) as either bridge to transplantation (n = 44) or destination therapy (n = 29). Our analysis focused on patients with late-onset infection (≥30 days) of the driveline exit site with prior clinical healing of all incisions. Results: Late driveline infections developed in 17 patients (23%) at a median of 158 days (intraquartile range [IQR]: 68 to 213 days) after implantation. The median duration of support in this subgroup was 400 days (IQR, 283 to 849 days). Despite an aggressive treatment algorithm, repeat surgical revision was needed in 12 patients, up to six times in 2 individuals. In 6 patients, the infection progressed to pump pocket infections that led to urgent heart transplantation (n = 4) or explantation (n = 2). The individual risk that a driveline infection would develop dramatically increased with the duration of support, reaching 94% at 1 year. Multivariate analysis identified duration of support (p < 0.001) and documented trauma at the driveline exit site (p < 0.001) as independent predictors of infection. Number and duration of readmissions to the hospital significantly increased (p < 0.001), and long-term follow-up for survival (4.4 ± 2.2 years, 100% complete) showed a trend towards impaired outcome after driveline infection (5-year survival: 41% versus 70%, p = 0.10). Conclusions: Long-term LVAD support in the current series was jeopardized by late-onset driveline infections, which occurred in all patients with support duration longer than 1 year. Once driveline infections developed, they were difficult to control and significantly increased morbidity. [Copyright &y& Elsevier]

Background: Severe neurologic complications after cardiac transplantation are devastating outcomes of this life-saving procedure. Incidence, risk factors, and morbidity of neurologic events in the modern era of cardiac transplantation are yet to be defined. Methods: Between 1996 and 2005, 200 patients (64% men; mean age, 49 ± 12 years) underwent heart transplantation at our institution. Overall, 46 patients (23%) showed a wide spectra of early neurologic complications. Results: Cause of ischemic complications was stroke in 11 patients (7 had concomitant epileptic seizures) and transient ischemic attack (TIA) in 7. Encephalopathy (n = 10), epileptic seizures unrelated to focal cerebral lesions (n = 7), severe headache (n = 6), cerebral infection (n = 3), and peripheral nervous system injuries (n = 2) completed the spectra of adverse neurologic outcomes. Multivariate analysis identified advanced age (p = 0.03), preoperative left ventricular assist device support (p = 0.02), preoperative intraaortic balloon pump support (p < 0.001), prolonged cardiopulmonary bypass time (p < 0.001), and postoperative hepatic failure (p = 0.04) as independent predictors of early neurologic complications. Postoperative morbidities associated with neurologic complications included longer ventilation time (p < 0.001), longer stay in the intensive care unit (p < 0.001), and higher incidence of pneumonia (p < 0.001) and sepsis (p = 0.01) compared with patients without neurologic events. There was a trend toward higher in-hospital mortality (15% versus 6%, p = 0.07), but there was no difference in long-term survival (65% versus 78%, p = 0.15). Conclusions: Despite rigorous pretransplantation screening, neurologic complications were common after cardiac transplantation. Most frequently, these complications were not the actual cause of death, but they significantly contributed to increased morbidity. Preoperative mechanical circulatory support requirement was the strongest predictor for adverse neurologic outcome. [Copyright &y& Elsevier]

Abstract: Background: Heart failure is a common and important cause of morbidity and mortality. Disease management offers promise in reducing the need for hospitalization and improving quality of life for heart failure patients, but experimental data on the efficacy of such programs are limited. Methods and Results: A total of 151 patients hospitalized with heart failure were randomized to usual care or scheduled telephone calls by specially trained nurses promoting self-management and guideline-based therapy as prescribed by primary physicians. Nurses also screened patients for heart failure exacerbations, which they managed with supplemental diuretics or by contacting the primary physician for instructions. Outcomes included time to hospital encounter, mortality, number and cost of hospitalizations, functional status, and satisfaction with care. Intervention patients had a longer time to encounter (hazard ratio [HR]=0.67; 95% confidence interval [CI] 0.47–0.96; P =.029), hospital readmission (HR=0.67; CI 0.46–0.99; P =.045), and heart failure–specific readmission (HR=0.62; CI 0.38–1.03; P =.063). The number of admissions, hospital days, and hospital costs were significantly lower during the first 6 months after intervention but not at 1 year. The intervention had little effect on functional status, mortality, and satisfaction with care. Conclusion: A nurse-administered, telephone-based disease management program delayed subsequent health care encounters, but had minimal impact on other outcomes. [Copyright &y& Elsevier]

Left ventricular assist device (LVAD) implantation has been shown to increase allosensitization before orthotopic heart transplantation, but the influence of LVAD support on posttransplant rejection is controversial. This study examines the postoperative incidence of acute cellular rejection (ACR) in patients bridged with continuous flow LVAD (CF-LVAD) relative to primary transplant (Primary Tx). All patients who underwent orthotopic heart transplantation at our institution between July 2006 and March 2019 were retrospectively reviewed (n = 395). Patients were classified into Primary Tx (n = 145) and CF-LVAD (n = 207) groups. Propensity score matching on 13 covariates implemented a 0.1 caliper logistic model with nearest neighbor 1:1 matching. Development of moderate to severe (ie, 2R/3R) rejection was evaluated using a competing risks model. Potential predictors of 2R/3R ACR were evaluated using Fine-Gray regression on the marginal subdistribution hazard. Propensity score matching yielded 122 patients in each group (n = 244). At 12 and 24 months, the cumulative incidence of 2R/3R ACR was 17% and 23% for the CF-LVAD group and 26% and 31%, respectively, for the Primary Tx group (P =.170). CF-LVAD was not predictive of 2R/3R rejection on multivariable Fine-Gray regression (subdistribution hazard ratio, 0.73; 95% confidence interval, 0.40-1.33; P =.301). There was no difference in the 5-year incidence of antibody mediated rejection (10% [n = 12] vs 9% [n = 11]; P =.827). After adjusting for covariates, CF-LVAD was not associated with an increased risk of moderate to severe ACR during the 24 months after cardiac transplantation. Further investigation is warranted with larger cohorts, but CF-LVAD may have minimal influence on posttransplant ACR. Depiction of the competing risks model showing 2R/3R acute cellular rejection (ACR), death, and composite end point survival (alive and free from rejection). Patients were stratified based on bridge to transplant (BTT) strategy (continuous flow left ventricular assist device (LVAD) support vs primary transplant) and propensity matched on baseline characteristics. On competing risks analysis of the matched groups, there was no significant difference in the incidence of 2R/3R ACR between groups (P =.170). CIF , Cumulative incidence function; KM , Kaplan-Meier. [Display omitted] [ABSTRACT FROM AUTHOR]

Left ventricular (LV) dysfunction is the most common reason that potential donor hearts are not allocated. However, a significant proportion of brain-dead donors (BDDs) have transient LV dysfunction, and these allocated hearts have equivalent post-transplant outcomes. It is difficult to determine which potential donors with cardiac dysfunction on initial assessment are likely to recover. Stress-induced cardiomyopathy (SIC) patterns, specifically reverse takatsubo's- LV basal hypokinesis with apical hyperkinesis, are often observed in BDDs, however its association with donor LV recovery remains unclear. We retrospectively reviewed echocardiograms from our OPO's recovery center to determine if specific strain patterns predict functional recovery. All BDDs managed at a single OPO recovery center between 1/1/2015-6/1/2018 with reduced initial LV ejection fraction (LVEF) ≤ 40% were included. Initial echocardiograms were adjudicated for image quality, with donors with poor quality or inability to obtain longitudinal strain (LS) excluded. All echocardiograms were interpreted by a single reader, with segmental and global longitudinal strain (SLS and GLS) analysis conducted in apical views. Composite LV apical and basal SLS obtained in each view were used to quantify apical-to-basal strain ratio. LV recovery was defined as an LVEF ≥ 50% on a subsequent echocardiogram during the evaluation process. 54 donors were included in this analysis, 29 (54%) had LV recovery and 25 (46%) donors did not have LV recovery. Donors with LV recovery had higher initial LVEF and greater overall LVEF improvement, with greater average overall LV and RV GLS (Table 1). The LV recovery group also had higher average LV apical and basal LS. However, LV, RV, apical, and basal LS were not independently associated with LV recovery when normalized for initial LVEF. Among all donors, the LV apical-to-basal LS ratio was 2.11 ± 1.7. There was no difference in apical-to-basal strain ratio between LV recovery and no recovery groups. Reverse takatsubo's-type pattern with elevated apical-to-basal LS ratio was generally observed among all BDDs with LV dysfunction, however this ratio was not associated with LV recovery. Multiple echocardiographic measures were associated with recovery, including initial LVEF, LV GLS and SLS. However, strain does not appear to provide added predictive value for recovery when accounting for initial LVEF. Additional work, combining imaging and clinical data, is needed to better predict donor LV recovery and thus expand the cardiac donor pool. [ABSTRACT FROM AUTHOR]

Implantable left ventricular assist device (LVAD) drive-line exit site infection, an expected consequence of currently available device use, continues to be a significant limiting factor in long-term support. We theorize that the mechanism behind the establishment of the most chronic exit site infections involves a shearing torsion injury that disrupts the tissue adherence interface with the drive-line. The resulting neo-epithelialized drainage tract prevents permanent clearance of the infection with antibiotics alone. The proposed treatment strategy of established infections involves aggressive surgical excision of the involved exit site. [Copyright &y& Elsevier]

Cardiovascular screening is recommended for first-degree relatives (FDRs) of patients with dilated cardiomyopathy (DCM), but the yield of FDR screening is uncertain for DCM patients without known familial DCM, for non-White FDRs, or for DCM partial phenotypes of left ventricular enlargement (LVE) or left ventricular systolic dysfunction (LVSD). This study examined the yield of clinical screening among reportedly unaffected FDRs of DCM patients. Adult FDRs of DCM patients at 25 sites completed screening echocardiograms and ECGs. Mixed models accounting for site heterogeneity and intrafamilial correlation were used to compare screen-based percentages of DCM, LVSD, or LVE by FDR demographics, cardiovascular risk factors, and proband genetics results. A total of 1,365 FDRs were included, with a mean age of 44.8 ± 16.9 years, 27.5% non-Hispanic Black, 9.8% Hispanic, and 61.7% women. Among screened FDRs, 14.1% had new diagnoses of DCM (2.1%), LVSD (3.6%), or LVE (8.4%). The percentage of FDRs with new diagnoses was higher for those aged 45 to 64 years than 18 to 44 years. The age-adjusted percentage of any finding was higher among FDRs with hypertension and obesity but did not differ statistically by race and ethnicity (16.2% for Hispanic, 15.2% for non-Hispanic Black, and 13.1% for non-Hispanic White) or sex (14.6% for women and 12.8% for men). FDRs whose probands carried clinically reportable variants were more likely to be identified with DCM. Cardiovascular screening identified new DCM-related findings among 1 in 7 reportedly unaffected FDRs regardless of race and ethnicity, underscoring the value of clinical screening in all FDRs. [Display omitted] [ABSTRACT FROM AUTHOR]

Background During left ventricular assist device implantation, a surgical tunneling technique to keep the entire driveline (DL) velour portion in the subcutaneous tunnel, resulting in a silicone-skin interface (SSI) at the exit site, has been adopted by many centers. To assess long-term freedom from DL infection associated with this technique, a multicenter SSI registry was initiated. It was hypothesized that the modified tunneling technique is associated with at least 50% reduction in DL infection at 1 year post-implant compared with the velour-to-skin method used in the HeartMate II (HMII) Destination Therapy (DT) trial. Methods SSI is a retrospective and prospective registry of patients who have received the HMII device. Results are reported from the retrospective cohort, which consists of 200 patients who were implanted during the period 2009–2012 with the SSI tunneling method and on HMII support for at least 10 months at the time of enrollment. The prevalence and incidence of DL infection after left ventricular assist device implantation in the SSI retrospective cohort were determined and compared with a control group of 201 patients also on HMII support for at least 10 months from the HMII DT clinical trial who were implanted during the period 2007–2009 using the traditional method in which a small section of the velour portion of the DL was externalized. Results The 1-year and 2-year prevalence rates of DL infection were 9% and 19% in the SSI patient group compared with 23% and 35% in the control group (hazard ratio 0.49, 95% confidence interval 0.33–0.73, p < 0.001). The event-per-patient year was 0.11 and 0.22 for the SSI and control groups, respectively ( p < 0.001). Based on a multivariate analysis, age and DL exit side were the only independent variables associated with DL infection. Effects of management changes over the eras were not studied and could have contributed to the findings. Conclusions These results suggest that leaving the entire DL velour portion below the skin is associated with 50% reduction in DL infection compared with results from the HMII DT trial. [ABSTRACT FROM AUTHOR]

: Background:Previous work shows that patients with heart failure patients who have peak oxygen consumption (Vo2 peak) >14 ml/kg/min do not derive a survival benefit from cardiac transplantation. However, this was shown before β-blocker therapy for patients with systolic heart failure became common, and β-blockers improve survival in patients with heart failure without changing Vo2 peak. Our purpose was to re-evaluate the utility of Vo2 peak >14 ml/kg/min as an indicator of the need for cardiac transplantation in patients with heart failure who are taking β-blockers.: Methods:Actuarial, hemodynamic, and exercise ventilatory data were collected from 540 patients with heart failure, 256 of whom were taking β-blockers. We tracked death and cardiac transplantation. We stratified the percentage of patients event-free 1 and 3 years after Vo2 peak study by their Vo2 peak and β-blocker status, and compared 1- and 3-year post-transplant survival (United Network of Organ Sharing [UNOS] data). We also compared total mortality for the patients with heart failure as stratified by β-blocker stats and Vo2 peak (excluding the 42 who underwent transplantation) with UNOS post-transplant survival.: Results:Patients with heart failure who were receiving β-blockers and whose Vo2 peak was ≥12 ml/kg/min had greater 1- and 3-year event-free survival rates (95% confidence intervals, 92.6%–96.6% and 85.8%–96.0%) than did post-transplant patients (83.9%–86.3% and 75.4%–76.6%). However, in patients with heart failure not taking β-blockers, Vo2 peak <14 ml/kg/min was associated with worse 3-year survival (38.9 - 62.1%) than that for post-transplant patients. Excluding the 42 patients with heart failure in our study who underwent transplantation and then evaluating survival of the remaining patients with heart failure (not event-free survival) did not substantially change these results.: Conclusions:Patients with heart failure who are receiving β-blockers do not derive a survival advantage at 1 and 3 years after cardiac transplantation if Vo2 peak is ≥12 ml/kg/min. Patients not taking β-blockers whose Vo2 peak is <14 ml/kg/min have superior survival with cardiac transplantation. [Copyright &y& Elsevier]

: ObjectivesOur aim was to determine the effect of β-adrenergic blockade on the prognostic value of peak oxygen consumption testing in patients with heart failure.: BackgroundPeak oxygen consumption has been shown to be a useful prognostic tool in patients with heart failure. However, studies demonstrating the utility of peak oxygen consumption were conducted before β-blocker therapy became widespread. Thus, our objective was to determine the effect of β-blockers on the prognostic value of peak oxygen consumption in patients with heart failure.: MethodsActuarial, anthropomorphic, hemodynamic and exercise ventilatory data were collected from 369 patients with heart failure. Death and orthotopic heart transplants were the events tracked. Patients were divided into those taking β-blockers and those not taking them. Event-free survival days were calculated.: ResultsOne hundred ninety-nine patients on β-blockers and 170 not on β-blockers were studied. There were 40 orthotopic heart transplants and 82 deaths during follow-up. Peak oxygen consumption (milliliters per kilogram per minute) trended toward being an independent predictor of event-free survival (p = 0.055). In patients on and not on β-blockers, a peak oxygen consumption of >14 ml/kg·min was associated with a 1-year event rate of approximately half of that associated with a peak oxygen consumption ≤14 ml/kg·min. However, for every level of peak oxygen consumption, the event rate was lower in the group taking β-blockers.: Conclusionsβ-blocker status does not change the predictive power of peak oxygen consumption in patients with heart failure, but β-blocker status is important to consider when using peak oxygen consumption to predict event-free survival in patients with heart failure. [Copyright &y& Elsevier]

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. [ABSTRACT FROM AUTHOR]