Destination Therapy Left Ventricular Assist Device Research Articles

Efficient measurement of multiple ventricular assist device patient-reported outcomes: Creation of a 20-item profile from the MCS A-QOL study

BackgroundPatient-reported outcome (PRO) measures of distinct concepts are often put together into patient profile assessments. When brief, profile assessments can decrease respondent burden and increase measure completion rates. In this report, we describe creation of five self-reported 4-item short forms and the MCS A-QOL 20-item profile to assess PROs specific to adjustment and health-related quality of life (HRQOL) among patients who undergo left ventricular assist device (LVAD) implantation. MethodsUsing a cross-sectional sample of patients (n=620) who underwent LVAD implantation at 12 U.S. sites or participated in the MyLVAD.com support group, we created five 4-item short forms: Satisfaction with Treatment, VAD Team Communication, Being Bothered by VAD Self-care and Limitations, Self-efficacy Regarding VAD self-care, and Stigma, which we combined into a 20-item Profile. Analyses included inter-correlations among measures, Cronbach’s alpha (i.e., internal consistency reliability)/score-level-specific reliability, and construct validity. ResultsThe 620 patients were mean age=57 years, 78% male, 70% white, and 56% on destination therapy LVADs. Inter-correlations among the five 4-item measures were low to moderate (<0.50), indicating they are associated yet largely distinct, and correlations with calibrated measures and 6-item short forms were >0.76, indicating their ability to reflect full-item bank scores. Internal consistency reliability for the five 4-item short forms ranged from acceptable (≥0.70) to good (≥0.80). Construct validity was demonstrated for these measures. ConclusionsOur five 4-item short forms are reliable and valid and may be used individually or together as a 20-item Profile to assess adjustment and HRQOL in patients who undergo LVAD implantation.

The Potential of the HeartLogicTM Algorithm in Patients with a Left Ventricular Assist Device, an Initial Report.

Survival and quality-of-life of left ventricular assist device (LVAD) recipients improved significantly because of growing experience and technological advances. However, LVAD-related complication rates, including recurrent episodes of congestion, remain high. Early detection of fluid retention to provide a time-window for medical intervention is the pillar in preventing hospitalizations. The multisensory HeartLogicTM algorithm accurately detected impending congestion in ambulant heart failure patients. The aim of the current study is to investigate the feasibility of HeartLogicTM-driven care in LVAD patients. Consecutive LVAD destination therapy patients were followed-up according the structured HeartLogicTM-based heart failure carepath. An alert triggered a device check-up, and the heart failure team contacted the patient to evaluate for signs and symptoms of impending congestion. An alert was adjudicated as true positive or unexplained. An episode of congestion not preceded by an alert was deemed as a false negative. Data from 7 patients were included: the median age was 67 years [IQR 61-71], 71% were male and 71% had a non-ischemic aetiology. Total follow-up entailed 12 patient-years. All patients experienced at least one alert. In total, 33 alerts were observed. Majority of alerts (70%, n = 23) were driven by congestion and one alerts (15%) were clinically meaningful but not primarily fluid-retention-related (e.g., altered hemodynamic triggered by a pump thrombosis). Of all the alerts, five (15%) were classified as an unexplained alert, and during follow-up, four false negative episodes were documented. HeartLogicTM-driven care with continuous monitoring to detect impending fluid retention in LVAD patients was feasible and deserves further prospective validation.

Left Ventricular Assist Device With External Iliac Artery Outflow Graft Anastomosis.

Durable left ventricular assist devices (LVADs) are a cornerstone therapy for patients with end-stage heart failure, and thus efforts to develop techniques that facilitate their use in an expanded population of patients are critical. Although the preferred outflow graft anastomosis site is the ascending aorta, alternative sites have been described including the descending thoracic and supraceliac abdominal aorta, as well as the innominate and axillary arteries. However, these vessels can be unfavorable targets in the setting of atherosclerosis, aneurysm, insufficient caliber, dissection, or complicated anatomy due to prior interventions. We present the case of a patient undergoing destination therapy LVAD implantation who had a complex surgical history leaving these targets unviable and thus necessitating selection of an alternative site. In this case, the right external iliac artery was successfully used for LVAD outflow graft anastomosis.

Abstract 18112: LVAD Recipient and Caregiver Perspective on Prognosis and End of Life Care: A Qualitative Study

Background: For left ventricular assist device (LVAD) recipients and caregivers, accurate understanding of prognosis is central to shared decision making. Our study evaluates (i) patient and caregiver estimated survival after a LVAD and (ii) describes how patients and caregivers rationalize estimated survival. Methods: We conducted a qualitative study with 18 LVAD recipients and 9 caregivers using semi-structured interviews. Interviews were transcribed and coded, with themes identified using rapid qualitative analysis. Results: Included patients had a median (range) age of 60.5 (28-83) years, 12 (67%) were men and 10 (56%) received their LVAD as destination therapy (DT). Participating caregivers included 8 (89%) women supporting 5 (56%) DT LVAD recipients. Depression was reported by 7 (39%) patients and 2 (22%) caregivers. Reported quality of life was low for most participants [median EQ-VAS score 60 (range 25-70) for patients and 50 (range 20-80) for caregivers]. Only 6 patients reported willingness to trade survival in favor of better quality of life. In the event of cardiac arrest, 15 (83%) patients and 7 (78%) caregivers reported wanting CPR for themselves or loved one. Although most participants reported health concerns primarily relating to their cardiac health and LVAD complications, both patients and caregivers provided high estimates of life expectancy [median 16 (range 3-45) and 14 (range 3-32) years respectively]. We identified three themes explaining how LVAD recipients and caregivers rationalize their estimated survival (i) survivor’s bias (ii) optimism (iii) minimization. Exemplary quotes are provided in the Table below. Conclusions: Several patients and caregivers reported low quality of life with concerns around poor cardiovascular health and LVAD complications. However, their estimated survival frequently exceeded clinically observed survival. This suggests an opportunity for improving patient-physician prognosis communication.

Pathophysiology and management of valvular disease in patients with destination left ventricular assist devices.

Over the last two decades, implantable continuous flow left ventricular assist devices (LVAD) have proven to be invaluable tools for the management of selected advanced heart failure patients, improving patient longevity and quality of life. The presence of concomitant valvular pathology, including that involving the tricuspid, mitral, and aortic valve, has important implications relating to the decision to move forward with LVAD implantation. Furthermore, the presence of concomitant valvular pathology often influences the surgical strategy for LVAD implantation. Concomitant valve repair or replacement is not uncommonly required in such circumstances, which increases surgical complexity and has demonstrated prognostic implications both short and longer term following LVAD implantation. Beyond the index operation, it is also well established that certain valvular pathologies may develop or worsen over time following LVAD support. The presence of pre-existing valvular pathology or that which develops following LVAD implant is of particular importance to the destination therapy LVAD patient population. As these patients are not expected to have the opportunity for heart transplantation in the future, optimization of LVAD support including ameliorating valvular disease is critical for the maximization of patient longevity and quality of life. As collective experience has grown over time, the ability of clinicians to effectively address concomitant valvular pathology in LVAD patients has improved in the pre-implant, implant, and post-implant phase, through both medical management and procedural optimization. Nevertheless, there remains uncertainty over many facets of concomitant valvular pathology in advanced heart failure patients, and the understanding of how to best approach these conditions in the LVAD patient population continues to evolve. Herein, we present a comprehensive review of the current state of the field relating to the pathophysiology and management of valvular disease in destination LVAD patients.

Systemic thrombolysis in the management of pump thrombosis in patients with left ventricular assist devices.

Left ventricular assist device (LVAD) implantation as destination therapy (DT) is a valuable treatment option in patients with end-stage heart failure ineligible for heart transplant. However, this therapy can be complicated by life-threatening pump thrombosis (PT). This case series reports our single-center experience with a structured systemic thrombolysis protocol in case of PT. Consecutive patients undergoing DT LVAD (HVAD, Medtronic, Framingham, MA) implantation between 2010 and April 2021 at our institution were reviewed and those with PT identified. Clinical, laboratory and LVAD specific data were collected and analyzed retrospectively. All patients with PT were treated with systemic thrombolysis according to a structured bedside protocol. Treatment was defined successful if a patient was alive at 30 days follow-up and free of recurrent PT, stroke or device exchange. Fourteen out of 94 patients experienced a PT after LVAD implantation (11%). Systemic thrombolysis was successful in 10 of 14 patients (71%) at 30 days. Two patients died within 30 days due to a hemothorax and multi-organ failure. In three patients treatment was complicated by a major bleeding; twice a hemothorax (one fatal) and one right calf bleeding. No intracerebral hemorrhage was observed. Three patients experienced a thrombotic complication within 30 days; all recurrent PT. Eleven of the 14 DT patients were discharged home after a limited hospital stay after thrombolysis (average of 11 days). In conclusion, systemic thrombolysis may be a reasonable option for life-threatening PT in this vulnerable DT group in whom device exchange is often impossible due to comorbidity.

Development of a non‐transplant left ventricular assist device program

Although the established long-term benefit of left ventricular assist device (LVAD) therapy has led to its proliferation as destination therapy (DT), few studies have evaluated LVAD outcomes at nontransplant centers. We undertook this study to better evaluate our experience in building a nontransplant, DT LVAD program. We conducted a retrospective review of all LVADs implanted from 2010 to 2021. Patient, operative, and outcome data were extracted from the electronic medical record. Secular trends were evaluated by organizing the data into eras of implant. Survival was assessed using the Kaplan-Meier method. Multivariable Cox proportional hazards regression models further evaluated outcomes. From 2010 to 2021, 100 primary LVAD implants were performed. Annual volume grew from 1 to 30 implants per year. The average age of our cohort was 65.7 years, most patients (80%) were male, 51% had an ischemic etiology, and 65 (65%) were INTERMACS profile 1 or 2. Our 1- and 2-year survival were 82% and 79%, respectively. Multivariable analysis of 1-year mortality demonstrated that decreasing renal function and increased cardiopulmonary bypass (CPB) time were associated with increased mortality while preoperative hemoglobin was protective. When stratified by era of implant, our most recent patients were more likely to be INTERMACS profile 1 or 2; had shorter CPB and aortic cross clamp times; required fewer reoperations for bleeding; and suffered less right ventricular failure requiring mechanical support. A single, nontransplant LVAD center can experience significant growth in volume in a high-acuity cohort while maintaining acceptable outcomes and quality of care.

“Would You Get A Destination Therapy Left Ventricular Assist Device?”: Health Care Providers Describe A Preference-sensitive Decision

Background In patients with advanced heart failure who are not transplant candidates, destination therapy left ventricular assist devices (DT-LVAD) are a potential life-prolonging treatment option, but also come with risks and burdens, creating a complex medical decision. Health care providers who care for these patients have exposure to a range of outcomes with DT-LVAD, and thus may provide perspective into the nature of this decision. Methods As part of the I-DECIDE-LVAD dissemination and implementation project, we surveyed clinical team members of mechanical circulatory support programs. The survey was distributed by cardiology professional societies and listservs over email in April 2019. The survey had 47 items, including a hypothetical question, “Personally, would you get a DT-LVAD If you had end-stage heart failure and were not eligible for transplant?” We collected personal and institutional characteristics of respondents and analyzed the data using chi squared tests and multivariate analyses. Results Responses were received from 530 healthcare providers, and 470 of those replied to the primary hypothetical question for this analysis. Respondents were 78.2% female, 18.7% male, and 2.6% did not respond; 12.8% physicians, 23.2% advanced practice providers, 41.6% registered nurses, 11.6% social workers, 8.5% other providers, and 2.4% did not respond. To the question of whether they would personally get a DT LVAD, 55 (10.4%) responded definitely, 231 (43.6%) responded probably, 149 (28.1%) responded probably not, 35 (6.6%) responded definitely not, and 60 (11.3%) did not respond. Men were more likely to respond affirmatively to the question than women (p = 0.0251). There was no association between responses to personally getting an LVAD and age, years working with LVAD patients, or role in the program. In analysis of programmatic factors, working at a heart transplant center was associated with affirmative responses to the question. There was not an association between response to personally getting an LVAD and type of institution (university, community based, or federally funded), volume of LVADs, or region of the country. Conclusion The majority of healthcare providers with direct exposure to LVADs express some ambivalence towards the therapy, emphasizing the dependence of this complex decision on personal preference and context. In patients with advanced heart failure who are not transplant candidates, destination therapy left ventricular assist devices (DT-LVAD) are a potential life-prolonging treatment option, but also come with risks and burdens, creating a complex medical decision. Health care providers who care for these patients have exposure to a range of outcomes with DT-LVAD, and thus may provide perspective into the nature of this decision. As part of the I-DECIDE-LVAD dissemination and implementation project, we surveyed clinical team members of mechanical circulatory support programs. The survey was distributed by cardiology professional societies and listservs over email in April 2019. The survey had 47 items, including a hypothetical question, “Personally, would you get a DT-LVAD If you had end-stage heart failure and were not eligible for transplant?” We collected personal and institutional characteristics of respondents and analyzed the data using chi squared tests and multivariate analyses. Responses were received from 530 healthcare providers, and 470 of those replied to the primary hypothetical question for this analysis. Respondents were 78.2% female, 18.7% male, and 2.6% did not respond; 12.8% physicians, 23.2% advanced practice providers, 41.6% registered nurses, 11.6% social workers, 8.5% other providers, and 2.4% did not respond. To the question of whether they would personally get a DT LVAD, 55 (10.4%) responded definitely, 231 (43.6%) responded probably, 149 (28.1%) responded probably not, 35 (6.6%) responded definitely not, and 60 (11.3%) did not respond. Men were more likely to respond affirmatively to the question than women (p = 0.0251). There was no association between responses to personally getting an LVAD and age, years working with LVAD patients, or role in the program. In analysis of programmatic factors, working at a heart transplant center was associated with affirmative responses to the question. There was not an association between response to personally getting an LVAD and type of institution (university, community based, or federally funded), volume of LVADs, or region of the country. The majority of healthcare providers with direct exposure to LVADs express some ambivalence towards the therapy, emphasizing the dependence of this complex decision on personal preference and context.

A Single Center Analysis Of Correlation Of Heartmate 3 Lvad Flows To Indirect Fick Method Derived By Swan-ganz Catheter

Background Heartmate 3 left ventricular assist device (LVAD) has been approved for end stage heart failure patients. The LVAD flows are calculated and are presumed to represent a surrogate for cardiac output (CO). We investigated if cardiac output measured by indirect fick method correlates with the LVAD flows in the peri-operative period to make clinical decisions. Methods This was a single center, retrospective analysis of patients post destination therapy LVAD implantation. LVAD flow (LF) derived from the LVAD was compared to the cardiac output calculated via indirect fick. Patients were also sub-categorized to opening of the aortic valve with use of echocardiogram. Additional data of each patients age, sex, height, weight,intermacs stage, pulmonary artery oxygenation saturation, peripheral arterial oxygenation,heart rate, hemoglobin and hematocrit were also reviewed. The LF, indirect fick CO measurements and opening of aortic valve were all measured within the first 72 hours post LVAD implant Results A total of 27 patients were used in the analysis of this study. The mean indirect fick calculated CO was 5.68 liters per minute (lpm) and the mean LVAD flow (LF) was 4.12lpm. Using Bland-Altman analysis, the fick derived CO systematically over-estimated cardiac output compared to the LVAD PF method (DeltaCO) by 1.56±1.11 L/min (95% CI 1.12 to 2.00,P < 0.001). The difference between the delta CO was not influenced by the flow from the aortic valve with P= 0.56 derived from the overall model. Additional sub-analysis of age, sex, height,weight, a low flow cardiac index of less than 2.2 L/min/m 2, low venous oxygenation, low hemoglobin values did not show statistical correlation of LVAD PF to indirect fick CO. Conclusion There was no significant correlation between the LVAD flow and an indirect fick CO in the first 72 hours post LVAD implant. LVAD flow should not be independently used to make relevant clinical decisions without hemodynamic guidance from swan-ganz catheter. Heartmate 3 left ventricular assist device (LVAD) has been approved for end stage heart failure patients. The LVAD flows are calculated and are presumed to represent a surrogate for cardiac output (CO). We investigated if cardiac output measured by indirect fick method correlates with the LVAD flows in the peri-operative period to make clinical decisions. This was a single center, retrospective analysis of patients post destination therapy LVAD implantation. LVAD flow (LF) derived from the LVAD was compared to the cardiac output calculated via indirect fick. Patients were also sub-categorized to opening of the aortic valve with use of echocardiogram. Additional data of each patients age, sex, height, weight,intermacs stage, pulmonary artery oxygenation saturation, peripheral arterial oxygenation,heart rate, hemoglobin and hematocrit were also reviewed. The LF, indirect fick CO measurements and opening of aortic valve were all measured within the first 72 hours post LVAD implant A total of 27 patients were used in the analysis of this study. The mean indirect fick calculated CO was 5.68 liters per minute (lpm) and the mean LVAD flow (LF) was 4.12lpm. Using Bland-Altman analysis, the fick derived CO systematically over-estimated cardiac output compared to the LVAD PF method (DeltaCO) by 1.56±1.11 L/min (95% CI 1.12 to 2.00,P < 0.001). The difference between the delta CO was not influenced by the flow from the aortic valve with P= 0.56 derived from the overall model. Additional sub-analysis of age, sex, height,weight, a low flow cardiac index of less than 2.2 L/min/m 2, low venous oxygenation, low hemoglobin values did not show statistical correlation of LVAD PF to indirect fick CO. There was no significant correlation between the LVAD flow and an indirect fick CO in the first 72 hours post LVAD implant. LVAD flow should not be independently used to make relevant clinical decisions without hemodynamic guidance from swan-ganz catheter.

Phenomapping a Novel Classification System for Patients With Destination Therapy Left Ventricular Assist Devices

Patients with continuous flow destination therapy (DT) left ventricular assist devices (LVAD) comprise a heterogeneous population. We hypothesized that phenotypic clustering of individuals with DT LVADs by their implantation characteristics will be associated with different long-term risk profiles. We analyzed 5,999 patients with continuous flow DT LVADs in Interagency Registry for Mechanically Assisted Circulatory Support using 18 continuous variable baseline characteristics. We Z-transformed the variables and applied a Gaussian finite mixture model to perform unsupervised clustering resulting in identification of 4 phenogroups. Survival analyses considered the competing risk for cumulative incidence of transplant or the composite end point of death or heart transplant where appropriate. Phenogroup 1 (n=1,163, 19%) was older (71 years) and primarily white (81%). Phenogroups 2 (n=648, 11%) and 3 (n=3,671, 61%) were of intermediate age (70 and 62 years), weight (85 and 87 kg), and ventricular size. Phenogroup 4 (n=517, 9%) was younger (40 years), heavier (108 kg), and more racially diverse. The cumulative incidence of death, heart transplant, bleeding, LVAD malfunction, and LVAD thrombosis differed among phenogroups. The highest incidence of death and the lowest rate of heart transplant was seen in phenogroup 1 (p <0.001). For adverse outcomes, phenogroup 4 had the lowest incidence of bleeding, whereas LVAD device thrombosis and malfunction were lowest in phenogroup 1 (p <0.001 for all). Finally, the incidence of stroke, infection, and renal dysfunction were not statistically different. In conclusion, the present unsupervised machine learning analysis identified 4 phenogroups with different rates of adverse outcomes and these findings underscore the influence of phenotypic heterogeneity on post-LVAD implantation outcomes.

Association between early ventricular arrhythmias and mortality in destination vs. bridge patients on continuous flow LVAD support

The association between ventricular arrhythmias (VAs) and mortality in patients supported by continuous flow left ventricular assist devices (LVAD) remains controversial. To evaluate the association between pre-implantation, early (≤ 30 day) post-implantation VAs and mortality in bridge to transplant (BTT) and destination therapy (DT) LVAD patients, separately. The risk factors for post LVAD VAs were also investigated. In this observational cohort study, we included 341 patients who received a first time, continuous flow LVAD between January 1st 2010 and July 30th 2018. We used Kaplan–Meier curves and multivariable cox regression analyses to study the association between VAs and mortality in the BTT and DT populations. The mean age of the cohort was 58 ± 14 years, with 82% males, 53% had ischemic cardiomyopathy, and 45% were DT. The mean follow-up was 2.2 ± 2.1 years. In both BTT and DT cohorts, pre LVAD VAs were not associated with mortality after LVAD implantation (log-rank p = 0.95 and p = 0.089, respectively). In the BTT population, early post-LVAD VAs were not statistically associated with increased mortality (log rank p = 0.072). In the DT patients, early post LVAD VAs were associated with a 67% increase in the hazards rate of mortality on LVAD support (HR 1.67 [1.05–2.65], p = 0.029). The final model was adjusted for type of cardiomyopathy, INTERMACS profile, glomerular filtration rate, post LVAD atrial fibrillation, age and cerebrovascular events. Early post-LVAD VA is common after LVAD implantation and is an independent predictor of mortality in the DT LVAD population.

Perceptions of Bereaved Caregivers and Clinicians About End-of-Life Care for Patients With Destination Therapy Left Ventricular Assist Devices.

BackgroundPatients with left ventricular assist devices (LVADs) implanted as destination therapy may receive suboptimal preparation for and care at the end of life, but there is limited understanding of the reasons for these shortcomings. Exploring perceptions of individuals (caregivers and clinicians) who are closely involved in the end‐of‐life experience with patients with destination therapy LVADs can help identify key opportunities for improving care.Methods and ResultsWe conducted semistructured qualitative interviews with 7 bereaved caregivers of patients with destination therapy LVADs and 10 interdisciplinary LVAD clinicians. Interviews explored perceptions of preparing for end of life, communicating about end of life, and providing and receiving end‐of‐life care, and were analyzed using a 2‐step team‐based inductive approach to coding and analysis. Six themes pertaining to end‐of‐life experiences were derived: (1) timing end‐of‐life discussions in the setting of unpredictable illness trajectories, (2) prioritizing end‐of‐life preparation and decision‐making, (3) communicating uncertainty while providing support and hope, (4) lack of consensus on responsibility for end‐of‐life discussions, (5) perception of the LVAD team as invincible, and (6) divergent perceptions of LVAD withdrawal.ConclusionsThis study revealed 6 unique aspects of end‐of‐life care for patients with destination therapy LVADs as reported by clinicians and caregivers. Themes coalesced around communication, team‐based care, and challenges unique to patients with LVADs at end of life. Programmatic changes may address some aspects, including training clinicians in LVAD‐specific communication skills. Other aspects, such as standardizing the role of the palliative care team and developing practical interventions that enable timely advance care planning during LVAD care, will require multifaceted interventions.

Cost-effectiveness of left ventricular assist devices as destination therapy in the United Kingdom.

AimsContinuous‐flow left ventricular assist devices (LVADs) as destination therapy (DT) are a recommended treatment by National Institute for Health and Care Excellence England for end‐stage heart failure patients ineligible for cardiac transplantation. Despite the fact that DT is frequently used as an LVAD indication across other major European countries and the United States, with consistent improvements in quality‐of‐life and longevity, National Health Service (NHS) England does not currently fund DT, mainly due to concerns over cost‐effectiveness. On the basis of the recently published ENDURANCE Supplemental Trial studying DT patients, we assessed for the first time the cost‐effectiveness of DT LVADs compared with medical management (MM) in the NHS England.Methods and resultsWe developed a Markov multiple‐state economic model using NHS cost data. LVAD survival and adverse event rates were derived from the ENDURANCE Supplemental Trial. MM survival was based on Seattle Heart Failure Model estimates in the absence of contemporary clinical trials for this population. Incremental cost‐effectiveness ratios (ICERs) were calculated over a lifetime horizon. A discount rate of 3.5% per year was applied to costs and benefits. Deterministic ICER was £46 207 per quality‐adjusted life year (QALY). Costs and utilities were £204 022 and 3.27 QALYs for the LVAD arm vs. £77 790 and 0.54 QALYs for the MM arm. Sensitivity analyses confirmed robustness of the primary analysis.ConclusionsThe implantation of the HeartWare™ HVAD™ System in patients ineligible for cardiac transplantation as DT is a cost‐effective therapy in the NHS England healthcare system under the end‐of‐life willingness‐to‐pay threshold of £50 000/QALY, which applies for VAD patients.

The relational dynamics of caregivers of patients with a left ventricular assist device for destination-therapy: A qualitative investigation

BackgroundCaregivers are critical to the recovery and management of patients with destination-therapy left ventricular assist devices (DT-LVADs). ObjectiveTo explore the needs and impacts of caregiving for patients with DT-LVAD relative to the various relationships caregivers navigate from the shared perspectives of patients, caregivers, and healthcare providers. MethodsQualitative descriptive secondary analysis. Patients with a DT-LVAD (n = 3), caregivers (n = 2), and healthcare providers (n = 13) from all DT-LVAD programs in Ontario, Canada were invited to participate in semi-structured interviews. We used thematic analysis to identify, analyze, organize, describe, and report caregiver-related themes. ResultsEighteen participants were interviewed. The needs and impact of caregiving for patients with DT-LVADs were characterized by connection with others (relational), and drastic and ongoing changes from normalcy within established and new relationships (dynamics). ConclusionsDT-LVAD caregivers’ unique needs may be a result of multi-leveled and compounding relational dynamics within and across established and new relationships. These could be considered to inform the content of targeted support strategies.

Phenomapping a Novel Classification System for Patients with Destination LVADs: An Unsupervised Machine Learning Cluster Analysis

Introduction Patients with continuous flow destination therapy (DT) left ventricular assist devices (LVAD) are a heterogenous population that may have distinct phenotypic clusters. Hypothesis We hypothesize there will be distinct phenotypic clustering of individuals with DT LVADs by their clinical characteristics at implantation that are associated with different long-term risk profiles. Methods We analyzed 8245 patients with a continuous flow DT LVADs in INTERMACS and selected 25 baseline clinical characteristics including demographic, echocardiographic, hemodynamic, and laboratory data. Variables with >10% missingness were excluded except for left ventricular dimensions which were imputated. Unsupervised K-means clustering derived phenogroups and the optimal number of clusters was assessed by minimization of the Bayesian Information Criterion. The final dataset included 5999 patients with 18 selected variables for 4 distinct phenogroups. Survival analyses for events considered competing risk for cumulative incidence of transplant or the composite endpoint of death or heart transplant when appropriate. Results Of the 4 phenogroups, phenogroup 1 (n=1163, 19%) was older (median age 71 years), primarily white (81%), and most frail (9%). Phenogroup 4 (n=517, 9%) was younger (41 years), heavier (108 kg), and more diverse (white race 46%) with the least frailty (3%), largest left ventricles (LVEDD 7.5 cm), and highest rate of non-adherence (8%) amongst the clusters. Phenogroups 2 (n=648, 11%) and 3 (n=3671, 61%) were of intermediate age (69 & 61 years), weight (87 & 90 kg), and ventricular size (LVEDD 6.5 & 6.9 cm). The cumulative incidence of death, heart transplant, bleeding, LVAD malfunction and LVAD thrombosis differed among phenogroups (Figure A-D). The highest cumulative incidence of death and the lowest rate of heart transplant was seen in phenogroup 1 (P Conclusions Our exploratory unsupervised machine learning analysis highlighted 4 phenogroups that differed in fatal and non-fatal adverse events. These observations underscore the influence of phenotypic heterogeneity on post-LVAD implantation outcomes.

Association Between Caregiver Burden and Patient Recovery After Left Ventricular Assist Device: Insights from Sustain-it

Introduction: While health-related quality of life (HRQOL) for patients with advanced heart failure is improved after left ventricular assist device (LVAD) implantation, caregivers (CGs) may experience worse quality of life due to new roles and responsibilities. CG burden is associated with worse outcomes in patients with other chronic illnesses, but the association between caregiver burden and patient recovery following LVAD implant for destination therapy (DT) has not been described. Methods: Between 10/1/15 and 12/31/18, 154 DT LVAD patients (age=60-80 years) and 108 DT CGs from 13 U.S. sites were enrolled. Of these, data through 1 post-operative year from 64 patients and CGs were analyzed. CG burden was measured using the Oberst Caregiver Burden Scale (OCBS): 15 items (range=1-5), measuring perceived amount of time spent and difficulty of tasks (higher score=more time on task and more difficulty of task), respectively. High CG burden=scoring greater than the cohort median. Patient recovery post-LVAD implant was defined by change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12), change in 6-minute walk distance (6MWD), and re-hospitalizations over 1 year. Proportional odds models for change in KCCQ-12 and 6MWD and linear regression for re-hospitalizations were used to assess for an association with CG burden. Results: Patients were 69.4±5.4 years, 86% male, and 91% White. Over the first year post-LVAD implant, 30% were hospitalized, 73% (47/64) had an improvement of at least 5 points on KCCQ-12 scores and 16% (10/64) a deterioration of at least 5 points. Mean 6MWD was 206.7 (SD, 133.9) meters at baseline and improved to 280.5 (SD, 102.5) meters at 1 year. CGs were 61.7±11.3 years, 94% female, 82% White, and 86% married. Median OCBS-difficulty score at baseline was 1.20 and median for time was 2.27. Higher CG burden was not associated with hospitalizations or changes in patient HRQOL or 6MWD over the first year following LVAD implant (table). Discussion: Higher CG burden at baseline was not associated with patient recovery in the first year post-LVAD implant. Understanding how CG burden is associated with patient outcomes following LVAD implant is important as lack of CG support is typically a contraindication for LVAD implantation.

The Effect of Age on Outcomes After Destination-Therapy Left Ventricular Assist Device Implantation: An Analysis of the IMACS Registry

BackgroundAs patients with advanced heart failure are living longer, defining the impact of left ventricular assist devices (LVADs) on outcomes in an aging population is of great importance. We describe overall survival, rates of adverse events (AEs), and post-AE survival in patients age ≥ 70 years vs age 50-69 years after destination-therapy (DT) LVAD implantation. MethodsA retrospective analysis was conducted with the use of the International Society for Heart and Lung Transplantation Mechanically Assisted Circulatory Support (IMACS) registry. All adults age ≥ 50 years with a continuous-flow DT LVAD from 2013 to 2017 were included. The primary outcome was all-cause mortality. The secondary outcomes were the incidence of and survival after gastrointestinal (GI) bleeding, infection, stroke, pump thrombosis, pump exchange, and right-side heart failure. Mortality and AEs were assessed with the use of competing risk models. ResultsAt total of 5,572 patients were included: 3,700 aged 50-69 and 1,872 aged ≥ 70. All-cause mortality by 42 months was 55.8% in patients aged ≥ 70 and 44.8% in patients aged 50-69 (P = 0.001). Patients aged ≥ 70 had a 37.8% higher risk of death after DT LVAD implantation (hazard ratio 1.378, 95% CI 1.251-1.517). Patients aged ≥ 70 had higher risk of GI bleeding but lower risk of right-side heart failure. There was no difference between age groups for risk of infection or stroke. Experiencing any AE was associated with an increased risk of death that did not vary with age. ConclusionsPatients aged ≥ 70 years have reduced survival after DT LVAD, in part because of increased GI bleeding, while the incidence of other AEs is similar to that of patients aged 50-69 years. Careful patient selection beyond age alone may allow for optimal outcomes after DT LVAD implantation.

Strategies of Wait-listing for Heart Transplant vs Durable Mechanical Circulatory Support Alone for Patients With Advanced Heart Failure

Given the shortage of donor hearts and improvement in outcomes with left ventricular assist device (LVAD) therapy, a relevant but, to date, unanswered question is whether select patients with advanced heart failure should receive LVAD destination therapy as an alternative to heart transplant. To determine whether a strategy of LVAD destination therapy is associated with similar survival benefit as wait-listing for heart transplant with or without LVAD therapy among patients with advanced heart failure. This retrospective propensity-matched cohort analysis used data on heart transplants from the United Network for Organ Sharing registry and LVAD implants from the Interagency Registry for Mechanically Assisted Circulatory Support from January 1, 2010, to December 31, 2014. The matched LVAD destination therapy cohort included 3411 patients. Data analysis for this study was conducted from December 22, 2017, to May 24, 2019. Survival at 5 years was analyzed using Cox proportional hazards models. In total, 8281 patients had albumin level, creatinine level, and BMI data recorded and were included in the analysis. Despite propensity score matching, the 3411 patients receiving LVAD destination therapy still tended to be slightly older than the 3411 patients wait-listed for heart transplant (64.0 years [interquartile range, 55.0-70.0 years] vs 60.0 [interquartile range, 54.0-65.0 years]; P < .001), but there was no significant difference in sex (2701 men [79.2%] vs 2648 men [77.6%]; P = .13). After propensity score matching for age, sex, body mass index, renal function, and albumin level, 3411 patients were wait-listed for heart transplant. This included 1607 patients with bridge to transplant LVAD therapy and 1804 patients without LVAD. The strategy of wait-listing for heart transplant was associated with better 5-year survival than LVAD destination therapy (risk ratio, 0.42; 95% CI, 0.38-0.46) after matching and adjusting for key clinical factors. This survival advantage was associated with heart transplant (adjusted risk ratio for time-dependent transplant status, 0.27; 95% CI, 0.24-0.32). The present analysis suggests that heart transplant with or without bridge to transplant LVAD therapy was associated with superior 5-year survival compared with LVAD destination therapy among patients matched on several relevant clinical factors. Continued improvement in LVAD technology, along with prospective comparative research, appears to be needed to amend this strategy.

Transplant Outcomes in Destination Therapy Left Ventricular Assist Device Patients.

Left ventricular assist devices (LVAD) can be implanted as either a bridge to transplantation (BTT) or destination therapy (DT). This definition is fluid, as some DT patients undergo transplantation. This study compared posttransplant outcomes between BTT and DT LVAD patients. We performed a retrospective analysis of LVAD patients who underwent cardiac transplantation from 2010 to 2016. Outcomes including mortality, rejection, infection, and overall readmission were assessed with univariable Cox analyses. This cohort included 92 LVAD patients underwent transplantation: 57 BTT, mean age 52 years, and 79% male. The DT group had a longer LVAD support time (median support 406 versus 161 days, p < 0.001) with no significant difference in 1-year survival (BTT 86% and DT 92%, p = 0.52) or survival time (HR 0.89, 95% confidence interval [CI] 0.33-2.41, p = 0.82). Rates of nonfatal adverse events were also similar between BTT and DT patients. In our cohort, DT patients had similar long-term survival and rates of adverse events as compared with BTT, despite a longer time to transplant. This study suggests that transplant outcomes are acceptable for patients initially labeled DT and that a longer duration of LVAD support may not adversely affect posttransplant outcomes.

Association of Patient Health-Related Quality of Life and Caregiver Burden in Older Heart Failure Patients Receiving Advanced Therapies: Findings from the SustainIng QualItY of Life of the Aged: Transplant or Mechanical Support (SustAIn-it) Study

Caregivers (CGs) of patients (PTs) with heart failure (HF) experience substantial CG burden. Poor PT health-related quality of life (HRQOL) correlates with increased CG burden in other chronic disease. We evaluated the relationship between PT HRQOL and CG burden in older PTs receiving left ventricular assist devices (LVAD) as destination therapy (DT) or awaiting heart transplant (HT) with or without an LVAD. Data were from SUSTAIN-IT, a study of PT and CG HRQOL in adults age 60-80 receiving DT LVAD or HT. PT HRQOL was assessed by EQ-5D-3L Visual Analog Scale (VAS) score: 0-100 (worst-best) & HF-specific KCCQ-12 summary score (SS), 0-100=low-high. CG burden was assessed by Oberst Caregiving Burden Scale (OCBS) assessing perceptions of CG difficulty & time (1-5; higher score=more time & difficulty). Baseline CG burden, PT HRQOL, and changes from 0 to 6 months were compared by linear regression. Data from 302 PTs and CGs were analyzed: 109 DT LVAD, 193 HT (101 without LVAD & 92 with LVAD). KCCQ-12 and EQ-5D VAS scores increased significantly from 0 to 6 months (p < 0.001). Baseline OCBS time had weak, but significant correlation with baseline PT KCCQ-12 (R=-0.26, p<0.001); correlation was slightly stronger at 6 months (R=-0.41, p<0.001). OCBS time was weakly associated with PT EQ-5D at 6 months (R=-0.2, p=0.009) but not at baseline (R=-0.1, p=0.09). Change in PT KCCQ-12 significantly correlated with change in OCBS time in DT LVAD (R=-0.33, p=0.01) but not HT with (p=0.46) or without LVAD (p=0.31). Change in PT EQ-5D and OCBS difficulty were not significantly correlated. PT HRQOL generally correlated with CG burden in older HF PTs before and early after DT and HT. Improved PT HRQOL did not correlate with decreased CG burden in HT, but may be associated in DT LVAD. These findings may guide support needs of CGs of PTs undergoing advanced therapies.