Left Ventricular Assist Device Program Research Articles

Myocardial Recovery With HeartMate 3 Left Ventricular Assist Device: An Attainable Goal That Needs Better Precision.

Despite advances in our understanding of myocardial recovery among left ventricular assist device (LVAD) patients, with 10-30% of patients achieving substantial myocardial improvement, the rates of LVAD support cessation remain extremely low (1-2%). These numbers are in stark contrast to clinical trial data where successful LVAD cessation is reported in up to 47% of patients. The majority of LVAD programs lack structured recovery programs and targeted protocols, likely underscoring the heterogeneity that exists among LVAD patients with myocardial recovery. This perspective summarizes the current medical and surgical challenges with respect to 1) identifying the appropriate candidates for LVAD cessation; 2) methods to wean LVAD support; 3) reviewing surgical techniques for cessation of current generation HeartMate 3 LVAD; and 4) approaching shared decision making for LVAD cessation between patients and providers given the uncertainties that remain in the field.

P70: Creative Collaboration through Co-management: Rethinking Care for Left Ventricular Assist Device (LVAD) Readmissions

Background: As a LVAD program supporting 300 patients, a large cohort of those patients will require readmission. The traditional model assigned all LVAD readmissions to a heart failure cardiologist, regardless of presenting diagnoses. This congested the cardiac LVAD cardiologist census, and often resulted in cardiologists directing care for non-cardiac diagnoses. Given more than half of readmissions were not cardiac in nature, a Co-management model utilizing the expertise of the hospitalist service was developed. Methods: An interdisciplinary team of heart failure cardiologists, hospitalists, and heart failure Advanced Practice Providers (APP) partnered together to develop a streamlined process for assigning readmitted LVAD patients to either a heart failure cardiologist or hospitalist. A group of five hospitalists completed a “LVAD bootcamp” to become familiar with the basics of LVAD care. The “Hospitalist LVAD patients” were also cared for by a heart failure APP with in-depth LVAD and heart failure knowledge. A heart failure cardiologist was always available for consultation. Patients were divided between the “Hospitalist LVAD” vs “Cardiac LVAD” team based on admitting diagnoses. A post-implementation survey was conducted and patient data pre and post introduction of the Co-management model was collected for review. Conclusion: The streamlined Co-management system of assigning readmitted LVAD patients based upon their admitting diagnoses to either a “Hospitalist LVAD” or “Cardiac LVAD” team ensured the assigned provider was able to best meet the specific patient care needs. With the support of LVAD coordinators, APPs, and other members of the multidisciplinary team, these patients received comprehensive care throughout the admission. Additionally, this improved process allowed the Cardiac LVAD team time to see patients in the outpatient LVAD clinic and ICU allowing for better utilization of resources. Clinical outcomes remained consistent throughout the implementation of this reimagined workflow. The Co-management model improved provider satisfaction.

Assessment of caregiver burden prior to implantation of left ventricular assist device: A national survey

Guidelines recommend incorporation of caregiver burden assessment and list significant caregiver burden as a relative contraindication when considering left-ventricular assist device (LVAD) implantation. To assess national practices regarding caregiver burden assessment, in 2019 we administered a 47-item survey to LVAD clinicians using 4 convenience samples. Responses were obtained from 191 registered nurses, 109 advance practice providers, 71 physicians, 59 social workers, and 40 others representing 132 LVAD programs; 125 of 173 total United States programs were included in the final analysis. While most programs (83.2%) assessed caregiver burden, assessment was most frequently conducted informally during social work evaluation (83.2%), with only 8.8% incorporating validated measures of caregiver burden. Larger programs were more likely to use a validated assessment measure (OR 6.68 [1.33-33.52]). Future research should focus on how programs can standardize caregiver burden assessment and how the level of burden may impact patient and caregiver outcomes.

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.

LVAD Program in Hong Kong

The implantable durable left ventricular assist device (LVAD) program at Queen Mary Hospital, Hong Kong, has been running since 2010. Whereas the number of implants have increased substantially throughout these ten years, the number of successful heart transplantation has remained static locally. The majority of LVAD implants has served as bridge to heart transplant to cope with the demand of end-stage heart failure. Our outcomes for LVAD implantation and heart transplant are comparable to international standard in the short and medium term. In this presentation of LVAD program in Hong Kong, the selection of patients, their optimization, the operative strategies and outcomes will be discussed. The implantable durable left ventricular assist device (LVAD) program at Queen Mary Hospital, Hong Kong, has been running since 2010. Whereas the number of implants have increased substantially throughout these ten years, the number of successful heart transplantation has remained static locally. The majority of LVAD implants has served as bridge to heart transplant to cope with the demand of end-stage heart failure. Our outcomes for LVAD implantation and heart transplant are comparable to international standard in the short and medium term. In this presentation of LVAD program in Hong Kong, the selection of patients, their optimization, the operative strategies and outcomes will be discussed.

Stress and Coping Among Family Caregivers of Patients With a Destination Therapy Left Ventricular Assist Device: A Multicenter Mixed Methods Study.

Family caregivers of patients with a destination therapy left ventricular assist device play a central and formalized role in postimplant care. We aimed to characterize longitudinal stress, predictors and correlates of stress, and coping processes among left ventricular assist device caregivers. We performed a sequential, exploratory, mixed-methods study from 6 diverse left ventricular assist device programs. The primary outcome for the quantitative analysis was the Perceived Stress Scale-10 at 6 months (0-40). Based on the quantitative findings and guided by the Transactional Model of Stress and Coping, semistructured interviews explored causes of stress and coping processes. Integration was performed during the qualitative and interpretation phase. A total of 96 caregivers met inclusion criteria for quantitative analysis. Mean (SD) Perceived Stress Scale score was 14.3 (5.5) preimplant and 11.8 (6.9) at 6 months. Preimplant, only decreased preparedness for caregiving was associated with higher Perceived Stress Scale score at 6 months. At 6 months, increased caregiver depressive symptoms, decreased caregiver preparedness for caregiving, and lower patient quality of life were associated with higher Perceived Stress Scale score. Qualitative analysis of 25 caregivers revealed the causes of stress coalesced around 3 themes: (1) lack of preparedness to be a caregiver, (2) uniqueness of stress for the caregiver and patient situation, and (3) caregiving responsibilities physically and emotionally impacting caregivers. To cope with stress, most caregivers employed emotion-focused coping. In family caregivers of patients with a left ventricular assist device, higher perceived stress was associated with lower caregiver preparedness, higher caregiver depressive symptoms, and lower patient quality of life. Emotion-focused coping strategies were common for caregivers. Future work should better prepare caregivers for this role and support them through the caregiving experience. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02344576.

Shared Care to Destination Therapy Left Ventricular Assist Device Site: a Novel Strategy to Start a Successful Mechanical Circulatory Support Program.

Heart failure is an important healthcare issue because of its high prevalence, mortality, and morbidity. Advanced heart failure therapies have improved significantly over the years with improved outcomes. Heart transplantation remains an elusive treatment option for most patients; hence, the need for alternative therapy has given rise to the use of mechanical circulatory support (MCS) devices, initially as bridge to transplantation, but with more recent use as destination therapy. This review focuses on the intricacies of establishing a successful left ventricular assist device (LVAD) program for destination therapy in the setting of a growing anticipated need for wider availability of such treatment options. Guidelines have established the role of MCS in patients with advanced HF refractory to optimal guideline-directed medical therapy (GDMT) and cardiac device interventions. Multiple studies have shown generational improvement in the overall safety profile of MCS devices with the use of newer devices for destination therapy showing improved outcomes. Heart failure is a growing cardiovascular problem with an anticipated growing need for advanced HF therapies including MCS devices. A model of shared care LVAD to destination therapy implanting site should be considered as a strategy to start a successful LVAD program.

Value of psychosocial evaluation for left ventricular assist device candidates.

Left ventricular assist devices require a psychosocial assessment to determine candidacy despite limited data correlating with outcome. Our objective is to determine whether the Stanford Integrated Psychosocial Assessment for Transplant, a tool validated for transplant and widely used by left ventricular assist device programs, predicts left ventricular assist device program hospital readmissions and death. We performed a retrospective analysis of adults at the Cleveland Clinic with Stanford Integrated Psychosocial Assessment for Transplant scores before primary left ventricular assist device program implantation from April 1, 2013, to December 31, 2018. The primary outcome was unplanned hospital readmissions censored at death, transplantation, and transfer of care. The secondary outcome was death. There were 263 patients in the left ventricular assist device program with a median (Q1, Q3) Stanford Integrated Psychosocial Assessment for Transplant score of 16 (8, 28). During a median follow-up 1.2years, 56 died, 65 underwent transplantation, and 21 had transferred care. There were 640 unplanned hospital readmissions among 250 patients with at least 1 outpatient visit at our center. In a multivariable analysis, Stanford Integrated Psychosocial Assessment for Transplant components but not total Stanford Integrated Psychosocial Assessment for Transplant score was associated with readmissions. Psychopathology (Stanford Integrated Psychosocial Assessment for Transplant C-IX) was associated with hemocompatibility (coefficient 0.21±standard error 0.11, P=.040) and cardiac (0.15±0.065, P=.02) readmissions. Patient readiness was associated with noncardiac (Stanford Integrated Psychosocial Assessment for Transplant A-III, 0.24±0.099, P=.016) and cardiac (Stanford Integrated Psychosocial Assessment for Transplant A-low total, 0.037±0.014, P=.007) readmissions. Poor living environment (Stanford Integrated Psychosocial Assessment for Transplant B-VIII) was associated with device-related readmissions (0.83±0.34, P=.014). Death was associated with organic psychopathology or neurocognitive impairment (Stanford Integrated Psychosocial Assessment for Transplant C-X, 0.59±0.21, P=.006). Total Stanford Integrated Psychosocial Assessment for Transplant score was not associated with left ventricular assist device program readmission or mortality. However, we identified certain Stanford Integrated Psychosocial Assessment for Transplant components that were associated with outcome and could be used to create a left ventricular assist device program specific psychosocial tool.

5-year results of a newly implemented mechanical circulatory support program for terminal heart failure patients in a Swiss non-cardiac transplant university hospital

BackgroundIn Switzerland, long-term circulatory support programs have been limited to heart transplant centers. In 2014, to improve the management of patients with end-stage heart failure not eligible for transplantation, we implemented a left ventricular assist device (LVAD) program for destination therapy at the University Hospital of Basel.MethodsWe described the program set-up with practical aspects. Patients aged 65 and above with therapy refractory end-stage heart failure without major contraindication for LVAD implantation were included. Younger patients with bridge-to-candidacy profile were also considered. Using the Kaplan-Meier estimate, we retrospectively analyzed the overall survival and freedom from major adverse events after LVAD implantation. We compared our results to internationally reported data.ResultsBetween October 2014 and September 2019, 16 patients received an LVAD in our center. The mean age at implantation was 67.1 years. The mean EuroSCORE II was 24.4% and the median INTERMACS level was 4. Thirteen patients received an LVAD as destination therapy and three patients as bridge-to-candidacy. The overall survival was 87.5 and 70% at 1 and 2 years, respectively. Freedom from stroke was 81.3% at 1 and 2 years. Freedom from device infection was 67.7 and 58.7% at 1 and 2 years, respectively. Freedom from gastrointestinal bleeding was 75 and 56.3% at 1 and 2 years, respectively. Freedom from readmission was 50 and 31.3% and at 6 months and 1 year, respectively.ConclusionsThe Basel experience demonstrated the possible implementation of an LVAD program for destination therapy or bridge-to-candidacy in a non-transplant comprehensive heart-failure center with midterm survival results and freedom from major adverse events comparable to international registries. Patient selection remains crucial.Trial registrationThis study was registered on the ClinicalTrials.gov database (NCT04263012).

Shared Decision-Making for Left Ventricular Assist Devices: Rationale and Design of a Nationwide Dissemination and Implementation Project.

Background The left ventricular assist device (LVAD) has become a common medical option for patients with end-stage heart failure. Although patients' chances of survival may increase with an LVAD compared with medical therapy, the LVAD poses many risks and requires major lifestyle changes, thus making it a complex medical decision. Our prior work found that a decision aid for LVADs significantly increased decision quality for both patients and caregivers and was successfully implemented at 6 LVAD programs. Methods In follow-up, we are conducting a nationwide dissemination and implementation project, with the goal of implementing the decision aid at as many of the 176 LVAD programs in the United States as possible. Guided by the Theory of Diffusion of Innovations, the project consists of 4 phases: (1) building a network; (2) promoting adoption; (3) supporting implementation; and (4) encouraging maintenance. Developing an LVAD network of contacts occurs by using a national baseline survey of LVAD clinicians, existing professional relationships, and an internet-based strategy. A suite of resources targeted to promote adoption and support implementation of the decision aid into standard LVAD education processes are provided to the network. Evaluation is guided by the Reach, Effectiveness, Adoption, Implementation, Maintenance framework, where clinician and patient surveys and qualitative interviews determine the reach, effectiveness, adoption, implementation, and maintenance achieved. Conclusions This project is a true dissemination study in that it targets the entire population of LVAD programs in the United States and is unique in its use of social marketing principles to promote adoption and implementation. The implementation plan is intended to serve as a test case and model for dissemination and implementation of other evidence-based decision support aids and strategies.

Surgical infection prophylaxis prior to left ventricular assist device implantation: A survey of clinical practice

Short duration, antimicrobial prophylaxis that includes antistaphylococcal activity is recommended at the time of left ventricular assist device (LVAD) implantation to reduce infection-related complications. There continues to be wide variability in surgical infection prophylaxis (SIP) regimens among implantation centers. The aim of this study is to characterize current SIP regimens at different LVAD centers. A survey study was conducted from 26 September 2017 to 25 October 2017. Surveys were distributed electronically to LVAD coordinators and infectious diseases specialists at 75 US medical centers identified as having an LVAD program. Data collection included information about antimicrobial selection, duration, Staphylococcus aureus screening, and decolonization procedures. We received 29 survey responses. The majority of surveys were completed by infectious diseases physicians (72.4% [21 out of 29]). Most responding centers reported LVAD programs established for greater than 10 years (20 out of 29 [69%]). Cardiac transplantation was performed in 28 out of 29 (96%) centers. Of centers reporting a defined SIP regimen for non-penicillin allergic patients (96% [28 out of 29]), 17.9% (5 out of 28) reported a four-drug regimen, 35.7% (10 out of 28) reported a three-drug regimen, and 46.4% (13 out of 28) reported a two-drug regimen, while no centers reported a single-drug regimen. Empiric fluconazole was common (50% [14 out of 28]) and 96.4% (27 out of 28) of regimens included vancomycin. Duration of antimicrobial prophylaxis (24 hours to 5 days), S. aureus screening, decolonization procedures, and alterations due to drug allergies varied across participating centers. Our survey results indicate wide variation in SIP regimens among participating LVAD centers. These results highlight the need for studies evaluating the implications of SIP regimens, and whether clinical factors that prolong antimicrobial duration impact postoperative infection rates.

Decision Aid Implementation among Left Ventricular Assist Device Programs Participating in the DECIDE-LVAD Stepped-Wedge Trial.

Background. Despite demonstrated efficacy, patient decision aids (DAs) are rarely used in clinical practice in the absence of coverage mandates. Deciding whether to pursue a left ventricular assist device (LVAD) is a major, preference-sensitive decision-ideal for exploring implementation of a DA. Methods. We conducted a type II effectiveness-implementation hybrid trial at 6 LVAD programs using a stepped-wedge cluster-randomized design. Using the RE-AIM framework, we collected both quantitative and qualitative outcomes, including a checklist collected by study staff for each enrolled patient regarding DA use and interviews with LVAD program clinicians preintervention, 6 months postintervention, and at the conclusion of the study. Results. From June 2015 to January 2017, 248 patients and their caregivers were enrolled. A total of 69 interviews were conducted with 48 clinicians at 3 time points. The DA reached 95% of eligible patients. Adoption was 100%, as all sites approached agreed to participate in the trial. Interviews revealed several themes related to the implementation of the DA: clinicians had a strong desire to ensure patients were informed and embraced the DA. Despite this, they reported communication challenges among their team that impeded implementation. Five of the 6 sites have maintained use of the DA following the trial; 1 site reported concerns about decreased procedural volume with use of the DA as a reason for discontinuation. Conclusions. In this hybrid trial, a DA for patients considering LVADs and their caregivers demonstrated high reach. Adoption and implementation were facilitated by a strong desire to ensure that patients were well informed. Future dissemination research and practice should attend to concerns about procedure volume and coverage mandates and facilitate ongoing communication at sites using the DA.

1176. Antibiotic Prophylaxis Strategies Prior to Left Ventricular Assist Device Implantation: A Survey of Practice

BackgroundShort duration, single-agent antimicrobial prophylaxis with anti-staphylococcal activity is recommended at the time of left ventricular assist device (LVAD) placement to prevent infection-related complications. Despite consensus guidelines, there continues to be wide variability in antimicrobial regimens among implantation centers. The aim of this study was to characterize current peri-operative antimicrobial prophylactic strategies at different LVAD implantation centers.MethodsA survey study was conducted from September 26, 2017 to October 25, 2017. Surveys were distributed electronically to both LVAD coordinators and infectious diseases specialists at 75 US medical centers identified as having an LVAD program. Data collection included information about antimicrobial selection, duration, MRSA screening and decolonization procedures.ResultsWe received 29 survey responses. The majority of surveys were completed by infectious diseases physicians [72.4% (21/29)]. Most responding centers reported LVAD programs established for >10 years [20/29 (69%)]. Cardiac transplantation was performed in 28/29 (96%) centers. Of centers reporting a defined antimicrobial prophylaxis regimen for nonpenicillin allergic patients [97% (28/29)], 17.9% (5/28) reported a four-drug regimen, 35.7% (10/28) reported a three-drug regimen, and 46.4% (13/28) reported a two-drug regimen, while no centers reported a single-drug regimen. Empiric fluconazole was common [50% (14/28)] and 96.4% (27/28) of regimens included Vancomycin. Duration of antimicrobial prophylaxis (24 h-5 d), MRSA screening, decolonization procedures, and alterations due to drug allergies varied significantly across participating centers.ConclusionOur survey results indicate a wide variation in the peri-operative antimicrobial prophylaxis regimens among participating LVAD centers. These results highlight the need for further studies evaluating the utility, toxicity, and stewardship implications of multi-drug regimens and whether specific clinical factors that prolong antimicrobial duration impact post-operative LVAD-related infection rates.DisclosuresRachel Miller, MD, Synexis: Research Grant.

Long-term discontinuation of antithrombotic therapy in patients with HeartMate II continuous-flow left ventricular assist device support.

Recurrent bleeding events are a common complication of left ventricular assist devices leading to significant morbidity. Clinicians may be reluctant to discontinue all antithrombotic therapies in this setting because of the risk of thrombotic events. To evaluate the safety of this strategy, we conducted a retrospective review of patients within our institution's left ventricular assist device program from February 2010 to July 2018 who had all antithrombotic therapies discontinued in response to recurrent bleeding events requiring hospitalization. Thrombotic and bleeding outcomes after discontinuation of therapy were assessed and compared. Seven patients out of 87 (8%) were identified and included in this analysis. One patient experienced pump thrombosis in the setting of driveline infection with an overall rate of thrombotic events of 0.08 per-patient-year. Sixteen gastrointestinal bleeding events occurred after discontinuation of antithrombotic therapy (1.35 per-patient-year) compared with 37 prior to discontinuation (4.28 per-patient-year) resulting in a significant reduction (reduction rate = 0.32; 95% confidence interval = [0.17, 0.58]; p < .001). Thrombotic complications were rare among patients with HeartMate II left ventricular assist device support who suffered recurrent bleeding events and in whom antithrombotic therapy was, therefore, discontinued. Gastrointestinal bleeding was significantly reduced in this group; however, angioectasia-related gastrointestinal bleedings remained problematic.

Assessment of pre-operative psychosocial function among people receiving left ventricular assist devices: A national survey of US LVAD programs

BackgroundThe International Society for Heart & Lung Transplantation (ISHLT) guidelines for Mechanical Circulatory Support (MCS) includes assessment of four elements of psychosocial functioning prior to Left Ventricular Assist Device (LVAD) implantation. Information about the practices and impact of assessments of psychosocial functioning are limited. ObjectiveTo describe the psychosocial function assessment practices used within US LVAD programs and the influence of psychosocial assessment results on clinical decisions for LVAD patient selection. MethodsIn 2017, a cross-sectional survey of LVAD programs listed in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) (N = 164) was conducted to understand practices used for and the influence of psychosocial assessments for post-operative care planning decisions. ResultsRespondents included representatives of 69 LVAD programs from throughout the U.S. that implanted 64.8% of all U.S LVADs in 2016. More than 39 psychosocial screening instruments were used. Assessment of family, social and emotional support occurred most frequently (84.1% (n = 58) of programs assessed 100% of patients), but assessment was least likely to be conducted with standardized instruments (36.2%). Cognitive dysfunction was the least likely characteristic to be assessed (26.1% (n = 18) of programs assessed 100% of patients), but was most often conducted with standardized instruments (53.8% of programs). Twenty seven percent of programs used non-standardized instruments or patient observation. The influence of assessments on clinical decisions to implant an LVAD was most influential in the bridge to transplant pathway with 60% (n = 39) of respondents rating it very influential and least influential for patients in the destination therapy pathway with 39.4% (n = 26) of respondents. ConclusionsCurrent psychosocial assessment practices in LVAD programs vary widely and often yield non-standardized, non-comparable data that may lead to variations in care and limit generation of an evidence base for decision making regarding psychosocial eligibility for LVAD implantation.

Mapping the Informed Consent Process for Left Ventricular Assist Devices.

Ethical, practical, and medical challenges affect decisions about left ventricular assist device (LVAD) implantation. The informed consent document (IC-Doc) is integral to the decision-making process and structures informed consent conversations. The objective of this study was to analyze IC-Docs to identify the information patients and their families receive about LVAD implantation to create a model IC-Doc. We requested IC-Doc for LVAD implantation from LVAD programs in the United States. We analyzed them in three areas: medical and technical content, patient knowledge gaps, and syntax. Nineteen IC-Docs representing all United Network of Organ Sharing regions were included. Seventeen (89.5%) mentioned the indications for LVAD implantation (bridge to transplant or destination therapy), and six indicated which category applied to the patient. Palliative care was mentioned as an alternative in nine (47.4%); no IC-Doc discussed nonsurgical palliative care. Eight forms (42.1%) specifically mentioned turning off the LVAD. Eighteen forms mention general bleeding, and four referred to long-term gastrointestinal bleeding. Two IC-Docs addressed driveline infections. One form was written at an 8th grade reading level. There is wide variation in LVAD IC-Docs and omission of some benefits and risks. We have written an IC-Doc that meets criteria for disclosure, fills many knowledge gaps, and has an acceptable readability score.

Left ventricular assist device (LVAD) program in Chile: first successful experience in South America.

The need to have a variety of tools to deal with end-stage heart failure (ES-HF), along with the limited heart transplantation availability encouraged us to create a pilot Left ventricular assist device (LVAD) program in a public health care system hospital in Chile. A retrospective analysis of the first nine patients of an ongoing LVAD program initiated on August 2013 was performed, completing an average of 30 months of follow-up. The most important events regarding to morbidity and mortality are described. Nine patients with ES-HF underwent LVAD implantation surgery; one of them died 23 days after surgery and another died after 11 months. One patient successfully underwent heart transplantation after 16 months of HeartWare ventricular assist device (HVAD) support; the other six patients remain in the program and have an average follow-up of 846 days at the time of this study (range, 23-1,481 days). The survival rate at 6, 12 and 18 months follow-up was 89%, 78% and 78% respectively. This new pioneering LVAD program in Chile has been successful and now constitutes a vital adjunct to all who work in heart transplantation and ES-HF programs. It offers an effective therapeutic alternative when there is a severe donor shortage, in cases of atypical blood types, emergencies, exceptional cases with contraindication for heart transplantation or when there is important donor-receiver size mismatch.

Successful establishment of a left ventricular assist device program in an emerging country: one year experience.

The primary goal of this study was to evaluate the outcomes of patients with end-stage heart failure (HF) who underwent continuous flow left ventricular assist device (CF-LVAD) in a developing country and to compare to those reported by more developed countries. The secondary goal was on determining factors that may be connected to improved survival. We prospectively analyzed 47 consecutive patients who underwent CF-LVAD at our institution. After one year the survival and adverse event profiles of patients were evaluated. At 3, 6 and 12 months, the cardiac, renal and liver function outcomes were assessed. The 30-day, 6-month and 1-year survival rates were 89%, 85% and 80%, respectively. A significant improvement in dimensions and ejection fraction of left ventricle, BNP, functional capacity, blood urea nitrogen (BUN) and total bilirubin (P<0.05 for all) were noticed 3 months post-CF-LVAD implantation, and patients were stable throughout the entire first year follow up. In the group of patients with baseline renal dysfunction (RD) there were significant improvements of renal function (P=0.004), with no changes on follow up. 57% of patients exhibited some kind of adverse event, commonly in the form of bleeding. In multivariate Cox regression analysis renal failure was found to be as an independent risk factor for the overall survival (HR =13.1, P<0.001). In conclusion, our data extends previous findings from centers of developed countries, that CF-LVAD is an adequate treatment option for patients suffering from end-stage HF, and encourages expansion of CF-LVAD implantation in developing countries with nascent HT program.

Left ventricular assist device therapy: the Kuwait experience.

Heart Failure is an epidemic with a current prevalence of over 5.8 million patients in the USA and almost 23 million patients worldwide, with high associated mortality risks. The severe shortage of donor organs for cardiac transplants and increasing number of heart failure patients has led to the increasing popularity of left ventricular assist device (LVAD) therapy for treatment of end-stage heart failure patients. This paper describes our initial clinical experience with LVAD therapy of heart failure patients at our clinic. Ten patients (eight males and two females) with a mean age of 48 years (range, 14-68 years) were implanted with LVADs as bridge to transplantation (BT) or destination therapy (DT) at our clinic between January 2015 and October 2017. Preliminary results were very promising with 0% 30-day mortality rates and no major surgical complications or LVAD thrombosis. Such results of LVAD implantation in Kuwait indicate the feasibility of establishing De Novo LVAD programs in low volume LVAD centers (≤10 implants/year) with promising results and offer a new era of hope for treating advanced heart failure patients.

Abstract 26: Left Ventricular Assist Device Evaluation and Education Processes Across Six Programs: Commonalities and Differences

Objective: To offer patients a left ventricular assist device (LVAD), programs complete a formal evaluation of the patient’s eligibility. While basic components of the evaluation are mandated by Centers for Medicare and Medicaid Services, the full process has never been systematically compared across sites. Methods: We conducted semi-structured interviews with multiple team members at 6 diverse LVAD programs. The interviews were audio recorded, transcribed, inductively coded, and analyzed with a team-based approach. Results: We interviewed 31 participants: 9 cardiologists, 3 surgeons, 3 nurse practitioners, 9 nurse coordinators, and 7 social workers (a total of 4-7 participants at each program). The formal LVAD evaluation process consisted of 3 main components: the medical/psychosocial evaluation to determine patient eligibility, educating the patient about the LVAD, and the multidisciplinary committee meeting to formally decide patients’ eligibility. While the basic tenants of the processes were similar across programs, 4 major differences emerged: (1) Standardization: some programs had a formal prescriptive pattern for how the process unfolded, such as order sets and timing of specific assessments, while others appeared to operate more sporadically; (2) Timing: some programs conducted patient education before the team’s decision on LVAD eligibility to assess patients’ interest in an LVAD as part of the final decision, whereas others did it after the committee meeting to prevent “false hopes” and wasted personnel time; (3) Location: programs conducted the LVAD evaluation process primarily inpatient following decompensation, or in both inpatient and outpatient settings which resulted in evaluating some patients earlier in the disease progression; (4) Personnel: some programs included certain team members’ assessments—particularly palliative care and social work—as integral in the eligibility decision, whereas other programs saw such input as peripheral. These differences affected how the medical teams and patients made decisions. The environment, attitude, speed, and personalities of the program shaped the way decisions were presented and made. Despite the variability, all programs reported similar challenges due to the complex patient population and the intricate relationships within the multidisciplinary teams. Overall, all programs expressed a universal goal of striving to implant the “appropriate patient”. Conclusion: Despite similar medical challenges and team structure, large variability was observed across LVAD programs, affecting how medical teams and patients made decisions. Standardization of the process at a higher level and communication between programs may help identify best practices and keep programs consistent. In turn, this could lead to better internal communication and education processes and ultimately improve patient care.