Left Ventricular Assist Device Centers Research Articles

Optimizing Triage of Ambulatory Patients With Advanced HeartFailure: 2-Year Outcomes From REVIVAL.

Left ventricular assist device (LVAD) use remains uncommon in advanced heart failure (HF) patients not dependent on inotropes. Before considering a randomized trial comparing a strategy of earlier use of LVAD to continued medical therapy, a better understanding is needed of the clinical trajectory of ambulatory patients with advanced systolic HF on optimal guideline-directed medical therapy (GDMT). REVIVAL enrolled 400 patients with advanced ambulatory systolic HF,≥1 HF mortality risk marker (≥2 HF hospitalizations past year; or HF hospitalization and high natriuretic peptide; or no HF hospitalizations but low peak oxygen consumption, 6-minute walk, serum sodium, HF survival score or Seattle HF model predicted survival), and no LVAD contraindication at 21 LVAD centers from July 2015 to June 2016. Patients were followed for 2 years or until a primary outcome (death, durable ventricular assist device, or urgent transplant). Clinical outcomes and health-related quality of life were evaluated. Mean baseline left ventricular ejection fraction was 21%, median 6-minute walk was 341 m, and 92% were Interagency Registry for Mechanically Assisted Circulatory Support profiles 5 to 7. Adherence to GDMT and electrical device therapies was robust. Composite primary outcome occurred in 22% and 37% at 1 and 2 years, with death alone in 8% and 16%, respectively. Patients surviving for 2 years maintained GDMT intensity and had no decline in health-related quality of life. Structured, serial follow-up at programs with expertise in caring for advanced ambulatory systolic HF patients facilitates triage for advanced therapies. Better strategies are still needed to avoid deaths in a small but significant group of patients who die without advanced therapies. REVIVAL patients not selected for VAD or transplant have robust survival and patient-reported outcomes, which challenges advocacy for earlier VAD implantation. (RegistryEvaluation of Vital Information for VADs in Ambulatory Life [REVIVAL]; NCT01369407).

(793) Validation of the Heartmate 3 Survival Risk Score in a Large Left Ventricular Assist Device Center

(793) Validation of the Heartmate 3 Survival Risk Score in a Large Left Ventricular Assist Device Center

A multidisciplinary approach for the emergency care of patients with left ventricular assist devices: A practical guide

The use of a left ventricular assist device (LVAD) as a bridge-to-transplantation or destination therapy to support cardiac function in patients with end-stage heart failure (HF) is increasing in all developed countries. However, the expertise needed to implant and manage patients referred for LVAD treatment is limited to a few reference centers, which are often located far from the patient's home. Although patients undergoing LVAD implantation should be permanently referred to the LVAD center for the management and follow-up of the device also after implantation, they would refer to the local healthcare service for routine assistance and urgent health issues related to the device or generic devices. Therefore, every clinician, from a bigger to a smaller center, should be prepared to manage LVAD carriers and the possible risks associated with LVAD management. Particularly, emergency treatment of patients with LVAD differs slightly from conventional emergency protocols and requires specific knowledge and a multidisciplinary approach to avoid ineffective treatment or dangerous consequences. This review aims to provide a standard protocol for managing emergency and urgency in patients with LVAD, elucidating the role of each healthcare professional and emphasizing the importance of collaboration between the emergency department, in-hospital ward, and LVAD reference center, as well as algorithms designed to ensure timely, adequate, and effective treatment to patients with LVAD.

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.

Defining Metrics for Short Term Success After LVAD Implant: An Analysis of the Society of Thoracic Surgeons Intermacs Registry

<h3>Purpose</h3> While clinical trials evaluating left ventricular assist device (LVAD) technology typically use composite outcomes to assess efficacy, composite outcomes including patient reported outcomes (PROs) have not been utilized as benchmarks for LVAD implant center performance improvement initiatives or quality ranking. The objective of the study was to assess the feasibility of generating a patient composite outcome measure including PROs from a real world registry. <h3>Methods</h3> Short term (ST, 180 days) adverse events (AEs) and mortality were tallied for Intermacs patients undergoing LVAD implant between 1/2012 and 12/2019. ST postoperative events included mortality on first device and frequencies of stroke, reoperation (device malfunction/other), right heart failure (RHF), prolonged respiratory failure, and/or dialysis on first device. Logistic regression was used to generate odds ratios for mortality for each AE. Separately, the EuroQOL visual analog scale (VAS) was assessed at baseline and 180 days in ST survivors. <h3>Results</h3> Of 20,115 patients, 37% suffered at least one event, most commonly death, reoperation and stroke (Table, column A). Stroke, prolonged respiratory failure, and dialysis attributed the most to ST mortality (Table, column B). Of the 16725 patients alive at 180 days, 43% completed a VAS with 82.0% showing VAS improvement. Renal failure and RHF contributed most to failure to improve VAS (Figure). <h3>Conclusion</h3> Assessment of a ST composite outcome metric after LVAD implant from a real world data source is feasible but limited by incomplete PRO reporting. ST adverse events display differential effects on mortality and PROs that can be used in development of global rank outcome scores. While reoperation is common, stroke, prolonged respiratory failure and renal failure conferred highest risks of ST deaths within Intermacs. Assessment of PROs should become a priority for LVAD centers to allow the field to generate a complete assessment of patient-centered outcomes.

Preventing driveline infection during left ventricular assist device support by the HeartMate 3: A survey-based study.

Driveline infection (DLI) is a significant source of morbidity and mortality during left ventricular assist device (LVAD) support yet limited studies are available to describe the center-level prevalence, preventive practices, and their potential effectiveness. We surveyed LVAD centers in the United States to determine program burden and preventive practices for DLI during HeartMate (HM) 3 support. An online, anonymous, question-based survey was sent to expert providers at implanting centers. Only a single respondent completed the survey for each center. As an exploratory analysis, we compared specific DLI preventive practices between centers with low (≤10%) and high (>10%) reported prevalence of DLI. Seventy-eight centers responded to the survey (response rate: 50%). Respondents were comprised of 37 (47%) heart failure cardiologists, 27 (35%) LVAD coordinators, and 14 (18%) cardiothoracic surgeons. The prevalence of DLI during HM3 was reported as ≤10% by 27 (35%), 11%-25% by 36 (46%), and >25% by 16 (19%) centers. Thirteen (17%) centers had a body mass index threshold for device placement, 29 (37%) utilized a counter incision, 66 (81%) placed an anchor stitch, and 69 (88%) used an external device to stabilize the DL. Proportionally, more centers with a low DLI prevalence used a wound vacuum 6 (22%) versus 3 (6%, p=0.03) than those with high DLI. Variation exists in reported prevalence and practices of preventing and managing driveline infections across centers during HM3 support. Further studies are warranted to develop and assess the effectiveness of standardized preventive strategies.

Access to Left Ventricular Assist Device: Travel Time Does Not Tell The Whole Story

BackgroundNegative health effects of traveling longer distances for surgical services have been reported. Given the high complexity of multidisciplinary care required for management of Left Ventricular Assist Device (LVAD) implantation, only 4 of 18 centers in our state perform these operations. Given the limited access we hypothesized increased travel time would adversely affect postoperative outcomes and 30-d mortality. MethodsA statewide Society of Thoracic Surgeons database was queried to identify patients undergoing Heartmate II/III and HVAD implantation, and 725 patients were identified. Travel time was calculated by zip code. Patients were stratified into regional and distant groups by the upper quartile of travel time (1-h). Preoperative variables and outcomes were compared between the groups. Multivariate analysis was performed to evaluate the impact of travel time in risk-adjusted models of 30-d mortality. ResultsMedian patient travel time to their LVAD center in our state is 32 min (mean 53 ± 65 min, 46 ± 71 miles). Patients in the distant group (n = 191) had lower median incomes, higher self-pay status, higher rates of medical comorbid disease. Despite these differences there was no difference between the groups in ICU and/or hospital length of stay, readmission, postoperative complications, or 30-d mortality. Multivariate regression demonstrated insurance status, age, and prior surgery predicted 30-d mortality, but not travel time. ConclusionsDespite only four centers in the state performing LVAD implantation, travel time was strongly associated with preoperative risk, and socioeconomic status but not postoperative outcomes or 30-d mortality. Therefore, increasing access should focus on insurance, and patient characteristics not travel time.

Primary Prevention Strategies for Driveline Infection during Left Ventricular Assist Device Support: A Survey of 55 Centers within the United States

<h3>Purpose</h3> Driveline infection (DLI) is a significant source of morbidity and mortality during left ventricular assist device (LVAD) support yet limited data are available to describe preventive practices and their potential effectiveness. <h3>Methods</h3> We surveyed LVAD centers within the United States to assess local practices for driveline stabilization and preventive approaches towards DLIs. An online, anonymous, question-based survey was created and sent to expert providers at implanting centers. Respondents were participants in FLIGHT and IDEAL heart failure (HF) working groups and only a single respondent completed the survey for each center. As an exploratory analysis, we compared specific DLI preventive practices between centers with low (≤10%) and high (>10%) reported rates of DLI. <h3>Results</h3> Representatives from 55 centers responded to the survey. Respondents comprised of 37 HF cardiologists, 14 cardiothoracic surgeons, 2 LVAD advanced practitioners and 2 LVAD RNs. The response rate was 95%. Centers were geographically well distributed throughout the United States and 80% reported implanting over 20 LVADs per year. Forty-five (81%) centers reported usage of an anchor stitch, 48 (87%) used an external device to stabilize the driveline, while 7 (13%) utilized a wound vacuum after device placement. Eighteen centers (33%) reported a low DLI rate in comparison to 37 (66%) reporting a high rate. Centers with low DLI rates trended to utilize an anchor stitch (94% vs. 76%, p=0.09) and wound vacuum (22% vs. 8%, p=0.14) more often than those with high DLI rates (figure 1). <h3>Conclusion</h3> Variation exists in preventive practices and DLI rates across centers. Although no significant differences were noted for assessed practices between centers with high and low DLI rates, further studies are warranted to determine the effectiveness of an anchor stitch and wound vacuum placement for preventing DLIs.

Social Determinants of Health and Rates of Implantation for Patients Considering Destination Therapy Left Ventricular Assist Device

A left ventricular assist device (LVAD) is a treatment option available to select patients with advanced heart failure. However, there are important social determinants of health that can play a role in determining patients' outcomes after device placement. We leveraged the DECIDE-LVAD Trial to assess social determinants of health-relationship status, household income, race/ethnicity, educational attainment, and health insurance-at the time of evaluation, and their association with rate of LVAD placement in the subsequent year. About a quarter of patients were unpartnered (i.e., single/divorced/widowed/separated; n = 55 [26%]). A similar proportion had a household income of less than $20,000 per year (n = 50 [24%]). Few patients were other race (n = 39 [18%]), had less than a high school education (n = 14 [6.6%]), or had Medicaid as their primary payor (n = 17 [8.4%]). LVAD implantation was significantly lower among patients who were unpartnered compared with patients who were married or partnered. LVAD implantation was not associated with income, race, educational attainment or insurance status. Our data from diverse LVAD centers at U.S. private and academic hospitals found that, among a broad sample of patients being evaluated for LVAD, married or partnered status was favorably associated with LVAD implantation, but other social determinants of health were not. Future research and policy changes should consider novel interventions for improving access to LVAD implantation for patients with inadequate social support.

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.

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.

Neurosurgical Management in Left Ventricular Assist Device (LVAD) Patients With Intracerebral Hemorrhage (ICH)

Abstract INTRODUCTION Intracranial hemorrhage (ICH) is one of the most dangerous events in patients with a left ventricular assist device (LVAD) and poses a significant management challenge for neurosurgeons. These patients require anticoagulation to prevent pump thrombosis; however, the occurrence of ICH mandates stoppage of anticoagulation to prevent further hemorrhage. Given this management challenge, our aim was to assess outcomes in LVAD patients who suffered an ICH. METHODS A retrospective review of a large volume LVAD center over a 2-yr period (January 2017-January 2019) was performed. LVAD patients with ICH requiring a neurosurgical consultation were identified. Hemorrhage type along with interventions and patient outcomes were recorded. RESULTS We identified 27 LVAD patients with ICH that received a neurosurgical consultation. The average INR at the time of ICH was 2.7 (1.0-8.8). Hemorrhage types seen were lobar (10/27, 37%), subarachnoid hemorrhage (SAH) (5/27, 19%), SDH (4/27, 15%), cerebellar ICH (3/27, 11%), multiple ICH (3/27, 11%), and hemorrhagic conversion (2/27, 7%). The overall mortality rate was 48.2% (13/27), with the highest mortality being in those patients who had multiple ICH at the time of presentation (3/3, 100%). The majority of patients with ICH (85.2%) were nonoperative. Lobar IPH was &gt;3 cm in 80% (8/10) of these, and 6/8 (75%) ultimately died. In total, 11% (3/27) received surgical intervention. Of these, 67% ultimately withdrew care. In total, 77% (10/13) of patients died as a result of the ICH. In total, 80% of patients with SAH were ultimately discharged home. CONCLUSION Patients with an LVAD and lobar IPH &gt;3 cm or multiple ICH had a universally poor prognosis despite any intervention. ICH type and size in LVAD patients may predict patient outcomes and could be used to triage operative vs nonoperative candidates.

Evaluation and Management of Gastrointestinal Bleeding After Left Ventricular Assist Device Placement: A National Multi-Center Survey Presidential Poster Award

Introduction: Gastrointestinal bleeding (GIB) is a well-described complication following Left Ventricular Assist Device (LVAD) placement. Standardized diagnostic guidelines for suspected GIB in LVAD patients are lacking. GIB often presents as overt or obscure, making a timely and accurate diagnosis difficult. We present the first multi-center experiential assessment on the current management practices of GIB in this population at major US-based LVAD centers. Methods: A 13-question and 12-question survey (Tables 1,2) were distributed by e-mail to practicing cardiologists and gastroenterologists at the top 100 US LVAD institutions. Surveys were developed with questions adapted to each specialty. The cardiology arm inquired on the number and type of LVADs placed, patient demographics, clinical characteristics, and management practices of those presenting with GIB. The gastroenterology arm focused on pre-VAD screening endoscopy practices, GIB presentation, GIB etiology, and endoscopic management GIB in LVAD patients. A concurrent review of the 8th INTERMACS Annual Report was conducted to assess national outcomes in LVAD patients. Results: A total of 91 and 103 surveys were distributed by e-mail to cardiologists and gastroenterologists, respectively. Twenty-seven cardiologists (29.7%) and 14 gastroenterologists (13.6%) responded. Most centers were large-volume, having implanted a total of >200 LVADs (55.6%). HeartMate devices were most often used (66.7%). In nearly half (52%) of centers, <25% patients underwent heart transplantation within 5 years of LVAD placement. 59.3% of respondents performed a pre-LVAD screening colonoscopy. For the index episode of GIB, 42.8% of gastroenterologists reported performing an EGD with colonoscopy. Melena (51.9%) was the most frequent presentation of GIB. A bleeding source was located in 40.4% of LVAD patients across centers (IQR = 5-80%), and was most often an AVM (85.7%). The most likely GIB location (77.8%) was the small bowel. The 8th annual INTERMACS report noted GIB usually occurs in the first 3 months post-LVAD (16.24 events/100 patient months). Conclusion: Post-LVAD placement GIB is a significant cause of morbidity and most often occurs in the first 3 months post-LVAD placement. Small bowel AVMs are the most commonly reported etiology. Further studies are needed to evaluate the role of pre-LVAD screening endoscopy, to develop an algorithmic approach to the management of GIB, and to evaluate medical therapy options in this patient population.538_A Figure 1 No Caption available.538_B Figure 2 No Caption available.

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.

Common clinical dilemmas in left ventricular assist device therapy: A glimpse into current trends

Background&#x0D; Left ventricular assist device (LVAD) therapy has been thrust into the forefront of surgical treatment for advanced heart failure (HF). Despite advancements in survival and quality of life with these devices, the multi-disciplinary care for these patients remains far from standardized across institutions.&#x0D; Methods &#x0D; A survey of current practices in LVAD was carried out at the St. Jude Medical User’s meeting representing a variety of caregivers including cardiac surgeons, HF cardiologists, non-HF cardiologists, advanced practice providers and ventricular assist device coordinators, with representation from several continents. Utilizing an audience response system, eleven questions were asked related to the demographics of the audience, left ventricular assist device patient selection and patient management.&#x0D; Results&#x0D; A total of 120 audience members representing both transplant and LVAD centers, destination therapy only LVAD centers and non-implanting, shared care centers across a multitude of disciplines responded to the survey. Questions comprised of patient selection (body mass index, pre-existing renal failure, care giver presence and abstinence from substance abuse) and patient management (anticoagulation regimens, first line therapy for hemolysis, implantable cardioverter-defibrillator usage and route of preferred dialysis) issues.&#x0D; Conclusions&#x0D; LVAD technology will continue to change and improve with the next generation of pumps on the horizon. Progress cannot be made without pausing to understand the current state of technology, practice patterns and patient determinants of success. This survey underscores the lack of consensus regarding best practice principles and the need for an increased focus on care management for LVAD patients with collaborative, multi-institutional studies.

Institutional volume of heart transplantation with left ventricular assist device explantation influences graft survival

There are increasing numbers of patients undergoing orthotopic heart transplantation (OHT) with left ventricular assist device (LVAD) explantation (LVAD explant-OHT). We hypothesized that LVAD explant-OHT is a more challenging surgical procedure compared to OHT without LVAD explantation and that institutional LVAD explant-OHT procedural volume would be associated with post-transplant graft survival. We sought to assess the impact of institutional volume of LVAD explant-OHT on post-transplant graft survival. This is a retrospective analysis of the Scientific Registry of Transplant Recipients for adult OHTs with long-term LVAD explantation. LVAD explant-OHT volume was characterized on the basis of the center's year-specific total OHT volume (OHTvol) and year-specific LVAD explant-OHT volume quartile (LVADvolQ). The effect of LVADvolQ on graft survival (death or re-transplantation) was analyzed. From 2004 to 2011, 2,681 patients underwent OHT with LVAD explantation (740 with HeartMate XVE, 1,877 with HeartMate II and 64 with HeartWare devices). LVAD explant-OHT at centers falling in the lowest LVADvolQ was associated with reduced post-transplant graft survival (p = 0.022). After adjusting for annualized OHTvol (HR = 0.998, 95% CI 0.993 to 1.003, p = 0.515 and pulsatile XVE (HR = 0.842, 95% CI 0.688 to 1.032, p = 0.098), multivariate analysis confirmed a significantly (approximately 37%) increased risk of post-transplant graft failure among explant-OHT procedures occurring at centers in the lowest volume quartile (HR = 1.371, 95% CI 1.030 to 1.825, p = 0.030). Graft survival is decreased when performed at centers falling in the lowest quartile of LVAD explant-OHT for a given year. This volume-survival relationship should be considered in the context of limited donor organ availability and the rapidly growing number of LVAD centers.

Institutional Volume of Heart Transplantation with Left Ventricular Assist Device Explantation Influences Graft Survival

<h3>Purpose</h3> There are increasing numbers of patients undergoing orthotopic heart transplantation (OHT) with left ventricular assist device (LVAD) explantation. We sought to assess the impact of institutional volume of LVAD explant-OHT on post-transplant graft survival. <h3>Methods and Materials</h3> This is a retrospective analysis of the Scientific Registry of Transplant Recipients for adult OHTs with long-term LVAD explantation. LVAD explant-OHT volume was characterized on the basis of the center's year-specific total OHT volume (OHTvol) and year-specific LVAD explant-OHT volume quartile (LVADvolQ). The effect of LVADvolQ on graft survival (death or re-transplantation) was analyzed. <h3>Results</h3> From 2004 to 2011, 2681 patients underwent OHT with LVAD explantation (740 HeartMate XVE, 1877 HeartMate II, 64 HeartWare). LVAD explant-OHT at centers falling in the lowest LVADvolQ (Q1) was associated with reduced post-transplant graft survival (p=0.022). After controlling for annualized OHTvol, which was not significant in this sample (HR=0.998, 95%CI=0.993-1.003, p=0.545), multivariate analysis confirmed a significantly (approximately 35%) increased risk of post-transplant graft failure among explant-OHT procedures occurring in centers in the lowest volume quartile (HR=1.352, 95%CI=1.012-1.798, p=0.038). <h3>Conclusions</h3> Graft survival is decreased when performed at centers falling in the lowest quartile of LVAD explant-OHT for a given year. This volume-survival relationship should be considered in the context of limited donor organ availability and rapidly proliferating LVAD centers. [figure 1]

Abstract 9887: Patient Selection for Ventricular Assist Device Therapy in the Elderly: Application of the HeartMate II Risk Score

Introduction: Advanced age is a risk factor for poor outcomes following left ventricular assist device (LVAD) implant. A means of identifying elderly patients with acceptable mortality risk following LVAD surgery is not currently available. The HeartMate II (HMII) Risk Score (HMRS) was recently developed and validated, providing good risk discrimination for predicting survival in patients undergoing HMII implant. Independent survival predictors in the model included age and markers of renal function, coagulopathy and nutrition. We hypothesize that the HMRS will provide utility for risk stratification of the elderly LVAD candidate. Methods: Elderly patients (age &gt;65 years) enrolled into the HMII Destination Therapy (DT) and Bridge to Transplant trials were selected for the study (n=444). Complete data for HMRS calculation was available in 98% (n=435). Preoperative patient HMRS was calculated according to the formula: HMRS = ln(1.29)*decade of age + ln(0.71)*Albumin + ln(1.37)*Cr + ln(1.86)*INR + ln(0.52)*LVAD Center Volume &gt;=15 + ln(0.67)*Implant after 2007. Patients were trichotimized into high (HMRS &gt;1.0), medium (HMRS 0.50-1.0), and low (HMRS &lt;=0.50) risk categories (as previously defined in model development) based on HMRS. The primary endpoint was survival at 1 year following LVAD implant, estimated using Kaplan-Meier methods. Results: The mean cohort age was 71±4 years and 84% (n=372) had devices implanted for DT. The table shows the HMRS along with mean±stddev values for the score's components. All between-group differences were statistically significant (Kruskal-Wallis p&lt;0.05), although differences in age were not clinically significant. Survival based on HMRS strata is shown in the figure. Patients in the low and medium risk groups had survivals &gt;80% at 1 year following LVAD implant. Conclusions: The HMRS can be used to identify elderly patients with survivals comparable to that of the general LVAD population.

Impact of Center Volume on Outcomes of Left Ventricular Assist Device Implantation as Destination Therapy

Background— More than 400 patients with end-stage heart failure underwent left ventricular assist device (LVAD) implantation of LVAD as destination therapy (DT) after the US Food and Drug Administration approval of DT in 2002. Because most of these patients had surgeries at hospitals that were newly accredited, we sought to examine the impact of LVAD center volume on the outcomes of DT. Methods and Results— From July 1998 through December 2005, a total of 377 patients underwent implantation of HeartMate I LVAD as DT at 68 centers in the United States. Using data from the Thoratec DT Registry, we examined the association between LVAD center volume at the time of surgery and 1-year survival with DT. Of the studied 377 DT recipients, 53% underwent device implantation at centers that performed ≤4 DT implants at the time of surgery. Center experience with DT seemed to significantly correlate with the 1-year survival (47.8% versus 67.4% in recipients of ≤4th DT versus &gt;9th DT implant; P =0.009). However, the DT center volume was not an independent predictor of 1-year survival with DT when adjusted for the preoperative DT Risk Score, suggesting that other factors, such as improved candidate selection, may have accounted for the institutional learning curve. Conclusions— The institutional experience with DT may have a significant impact on outcomes of this therapy. Better selection of candidates, systemic approach to surgical and postoperative care, as well as the long-term medical management most likely all contribute to these improvements.