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Background The current representation of female patients and racial and ethnic minorities in cardiovascular trials is unclear. We evaluated these groups’ inclusion in U.S. cardiovascular trials. Methods Using publicly available data from ClinicalTrials.gov , we evaluated cardiovascular trials pertaining to coronary artery bypass grafting (CABG), heart valve disease, aortic aneurysm, ventricular assist devices, and heart transplantation. This yielded 178 U.S. trials (159 completed, 19 active but not recruiting) started between September 1998 and May 2017, with 237,132 participants. To examine female patients’ and racial and ethnic minorities’ representation in these trials, we calculated participation-to-prevalence ratios (PPRs). Values of 0.8 to 1.2 reflect similar representation. Results All 178 trials reported sex distribution, whereas only 76 (42.7%) trials reported racial distribution and 52 (29.2%) trials reported ethnic (Hispanic vs non-Hispanic) distribution. Among all trials, participants were 28.3% female, 11.2% were Hispanic/Latino, 4.0% were African American, 10.4% were Asian, and 2.3% were other. The CABG PPR for female patients was 0.64, for Hispanic patients was 0.72, for African American patients was 0.28, and for Asian patients was 3.20. Between 2008-2012 and 2013-2017, the CABG PPR decreased for female patients (0.67→0.50) and African American patients (0.37→0.17) but increased for Hispanic patients (0.38→1.32) and Asian patients (3.51→4.57). Conclusions Participation in cardiovascular trials by female patients and minorities (except Asian patients) remains low. Given that inherent differences among the previously mentioned groups could affect outcomes, balance is clearly needed. The engagement of our surgical leadership, community, and industry to address these disparities is vitally important.

Left ventricular assist device (LVAD) implantations have traditionally been approached through a full median sternotomy (FS). Recently, a minimally invasive left thoracotomy (LT) approach has been popularized. This study sought to compare the outcomes of FS and LT patients post-primary LVAD implantation and post-subsequent heart transplant (HT). This was a single-center retrospective study. 83 patients who underwent primary centrifugal durable LVAD implantation from January 2014 to June 2018 were included (FS, n = 41; LT, n = 42). 41 patients had a subsequent HT (FS, n = 19; LT, n = 22). Pre-operative patient demographics, intraoperative variables, post-operative 1-year survival, length of hospital stay, complications, and outcomes for LVAD implantation and following HT were analyzed. Intraoperative data showed that the LT group had a 23.4% longer mean LVAD implant surgical time (p

Mechanical circulatory support may result in sufficient myocardial recovery to allow for explantation of the left ventricular assist device (LVAD). The duration of support associated with left ventricular recovery has generally been 6–12 months. In this report, we present a patient in whom the left ventricle recovered after 5 years of support with a LVAD. Our report demonstrates that long-term monitoring for left ventricular recovery is prudent and may allow for late device explantation.

Prior studies have examined the effect of blood type on heart transplantation (HTx) waitlist outcomes in cohorts through 2015. We aim to analyze the effect of blood type on contemporary waitlist outcomes with a new allocation system focus.Adults listed for HTx between April 2015 and December 2020 were included. Survival to HTx and waitlist death/deterioration was compared between type O and non-type O candidates using competing risks regression. Donor/recipient ABO compatibility trends were further investigated.Candidates with blood type O (n = 7509) underwent HTx less frequently than candidates with blood type other than type O (n = 9699) (subhazard ratio [sHR], 0.56; 95% CI, 0.53-0.58) with higher rates of waitlist death/deterioration (sHR, 1.18; 95% CI, 1.04-1.34). Subgroup analyses demonstrated persistence of this trend under the new donor heart allocation system (HTx: sHR, 0.58; 95% CI, 0.54-0.62; death/clinical deterioration: sHR, 1.27; 95% CI, 1.02-1.60), especially among those listed at high status (1, 2, or 3) (HTx: sHR, 0.69; 95% CI, 0.63-0.75; death/deterioration: sHR, 1.61; 95% CI, 1.16-2.22). Among those listed at status 3, waitlist death/deterioration was modified by presence of a durable left ventricular assist device (left ventricular assist device: sHR, 1.57; 95% CI, 0.58-4.29; no left ventricular assist device: sHR, 3.79; 95% CI, 1.28-11.2). Type O donor heart allocation to secondary ABO candidates increased in the new system (14.5% vs 12.0%; P .01); post-HTx survival remained comparable between recipients with blood type O and non-type O (log-rank P = .07).Further logistical considerations are warranted to minimize allocation inequity regarding blood type under the new allocation system.

Current donor-recipient size matching guidelines rely primarily on body weight, with no specified oversizing cutoff values. Recent literature has explored predicted total ventricular mass matching over body weight matching. We aim to explore the impact of total ventricular mass oversizing on heart transplant outcomes.The United Network for Organ Sharing database was queried for adults who underwent primary heart transplant from 1997 to 2017. By using validated equations, donor-recipient total ventricular mass mismatch was calculated. Donor-recipient pairs were divided into 3 groups by total ventricular mass mismatch. Post-heart transplant 1-year survival was analyzed using the Kaplan-Meier method and Cox proportional hazards models. We also investigated post-heart transplant complications, independent predictors for mortality, donor-recipient sex mismatch, and donor-recipient body habitus in total ventricular mass mismatch greater than +50%.A total of 34,455 donor-recipient pairs were included. Fractional polynomial regression demonstrated increased the risk of mortality with higher total ventricular mass mismatch. Total ventricular mass mismatch of +48.3% maximized the Youden Index. Donor-recipient pairs were subsequently grouped by total ventricular mass mismatch as -20% to +30%, +30% to +50%, and greater than +50%. Total ventricular mass mismatch greater than +50% was an independent risk factor for 1-year mortality (hazard ratio, 1.40, P = .004) and was associated with increased postoperative stroke (P = .002). Some 80.3% of these recipients were smaller female patients with male donors. Total ventricular mass mismatch from +30% to +50% was not associated with worse survival (P = .17).Total ventricular mass mismatch greater than +50% is associated with worse 1-year survival, although this group comprises a small portion of heart transplant. total ventricular mass mismatch from +30% to +50% is not associated with worse survival. These outcomes should be considered in selecting donors and in efforts to expand the potential donor pool.

The number of patients on destination therapy is increasing as long-term survival on continuous-flow left ventricular assist device (CF-LVAD) therapy has improved. Gastrointestinal bleeding (GIB) is a common complication after CF-LVAD implantation, and its risk correlates with longer support time, emphasizing the importance of GIB management. The lower pulsatility of CF-LVADs may promote arteriovenous malformations, which amplify the bleeding risk. Here, we retrospectively analyzed the location, incidence, and survival effect of GIB events in HeartMate II (HM-II) and HeartWare Ventricular Assist Device (HVAD) recipients to provide specific details regarding these complications. From November 2003 to March 2016, 526 patients with chronic heart failure underwent primary implantation of an HM-II (n = 403) or HVAD (n = 123) CF-LVAD at our center. Of the 526 patients, 140 (26.6%) had a GIB event (HM-II: n = 100; HVAD: n = 40), 92 (17.5%) had a single GIB event, and 48 (9.1%) had multiple GIB events (range: 2-9 events). HVAD recipients had a higher incidence of both upper and lower GIB events (p < 0.001 and P = 0.002, respectively) than HM-II recipients. Arteriovenous malformation was the most common etiology for GIB (50 patients/72 events); for this group, the average time-to-event was 300.4 days, the recurrence rate was 34%, and the 90-day and 1-year survival rates were 88.3% and 66.7%, respectively. Age at implantation was the only predictor of GIB. In conclusion, our study provides detailed information about GIB events associated with current CF-LVADs. Additional studies are required to evaluate strategies to reduce the incidence of GIB morbidity.

Ischemic time (IT) under the new heart transplant (HTx) allocation system has increased compared to the old system. We investigated the effect of IT and donor age on post-HTx survival.The United Network for Organ Sharing (UNOS) database was analyzed to identify adult HTx between October 2015 and August 2020. Recipients were stratified by donor age, transplantation era, and IT. Kaplan-Meier and log-rank tests were used to compare 180-day post-HTx mortality. Cox proportional hazards modeling and propensity score matching were performed to adjust for confounders.Under the new system (N = 3654), IT≥4 h led to decreased survival compared to IT 4 h (91.4% vs. 93.7%; P = .02), although this decrease was undetectable among those with donors ≥39 years old (90.4% vs. 91.1%; P = .73). IT≥4 h led to decreased survival with donors 39 years old (91.7% vs. 94.6%; P .01). Under the old system (N = 5987), IT≥4 h resulted in decreased survival (89.8% vs. 93.9%; P .01), including with donors ≥39 years old (86.9% vs. 92.4%; P .01).IT≥4 h remains a risk for post-HTx mortality under the new system. However, the magnitude of this effect is blunted when donor age is ≥39 years, likely secondary to increased allocation of these organs to lower status, more stable recipients.

While the utilization of extended criteria donors (ECDs) are traditionally avoided for poorer outcomes, management of HTx recipients has evolved over the past decades. We sought to examine the temporal trends in outcomes of ECDs in HTx.We queried the UNOS database for adult HTx that fit the EXPAND Trial criteria for ECDs: ischemic time ≥ 4 hours, ejection fraction50%, age55 years, and history of coronary artery disease. Transplant years were stratified as follows: 2000-2004, 2005 - 2009, 2010 - 2014, and 2014 - 2018. Two-sample t-test, Kaplan Meier survival, log-rank test, analysis of variance, multivariable Cox proportional hazards, and Multinomial Logistic Regression were used to compare data between periods.39,028 patients were stratified through Periods 1-4 as follows: 9,217 (2,942 ECD, 31.9%), 9,224 (2,730 ECD, 29.6%), 10,309 (2,762 ECD, 26.8%), and 10,278 (2,190 ECD, 21.3%). Transplants utilizing ECDs in Periods 1 and 2 had increased one-year mortality compared to Periods 3 and 4 (16.9% and 15.6% vs 11.9% and 10.9% respectively, P0.001). Later periods also demonstrated improved Karnofsky scores (P0.001).While use of ECDs has decreased across the periods, we noted significant improvement in 1-year survival rate, as well as postoperative functional status.

The new donor heart allocation system prioritizes candidates supported by temporary devices. However, waitlist and posttransplant outcomes in candidates with durable left ventricular assist device (LVAD) remain to be elucidated. The United Network for Organ Sharing database was queried for adults listed from October 2015 to March 2020 for a single-organ, first-time heart transplant (HTx) with a durable LVAD. Waitlist removal within 1 year because of death or clinical deterioration and HTx was analyzed using competing risks regression. Candidates who underwent HTx within 1 year of listing were identified for examination of post-HTx survival using the Kaplan-Meier method and Cox proportional hazards models. Compared with candidates listed under the old system (n = 2,122), candidates listed under the new system (n = 1,562) were slightly younger (p = 0.04) but had higher body mass index (p < 0.01). Those listed under the new system were significantly less likely to experience waitlist removal because of death or clinical deterioration (subhazard ratio [HR] 0.68, 95% CI 0.52-0.90) but were also less likely to undergo HTx (sub-HR 0.91, 95% CI 0.83-0.998). Those who survived to HTx were more likely to experience death or need for re-HTx within 1 year of HTx under the new system (adjusted HR 1.50, 95% CI 1.11-2.03). Candidates with durable LVAD experience favorable waitlist outcomes under the new allocation system, although those who undergo HTx may be at increased mortality risk. Thus, candidates with a durable LVAD should be carefully selected for HTx listing under the new allocation system.

Recent research has explored the use of higher risk extended criteria donors (ECDs) as a means of expanding the donor pool for heart transplantation. Here we sought to explore the current geographic distribution and survival outcomes of ECD utilization in various regions across the United States.The United Network for Organ Sharing database was retrospectively queried for adult primary heart transplantation from 2000 to 2019. The EXPAND trial definition of ECD was used: ischemic time ≥ 4 hours, ejection fraction50%, age55 years, and history of coronary artery disease. Geographic data and 2019 population estimates were obtained from the US Census Bureau.Of the 42 642 transplants included in our analysis, 11 750 (27.6%) used ECDs. Region utilization of ECDs ranged from 18.4% to 46.5% of transplants. Region 6 had the highest utilization rate at 46.5%; this was primarily driven by the number of transplants with ischemic time ≥ 4 hours. Region 6 encompasses the largest total area (1.08 million square miles) and smallest population density (15.6 people per square mile). Region 8 had the lowest marginal donor utilization rate at 18.4%. Regions with high utilization of low ejection fractions, older donors, and donors with coronary artery disease (ie, regions 1 and 2) were able to maintain an average utilization rate of ECDs by maintaining short ischemic times.Large discrepancies in the use of ECDs exist across the different United Network for Organ Sharing regions. This is primarily driven by longer ischemic times, likely guided by variance in population densities between different regions.

To determine whether the cause of cardiomyopathy affects outcomes in patients who undergo continuous-flow left ventricular assist device support, we compared postimplant adverse events and survival between patients with ischemic and nonischemic cardiomyopathy. The inclusion criteria for the ischemic group were a history of myocardial infarction or revascularization (coronary artery bypass grafting or percutaneous coronary intervention), ≥75% stenosis of the left main or proximal left anterior descending coronary artery, or ≥75% stenosis of ≥2 epicardial vessels. From November 2003 through March 2016, 526 patients underwent device support: 256 (48.7%) in the ischemic group and 270 (51.3%) in the nonischemic group. The ischemic group was older (60.0 vs 50.0 yr), included more men than women (84.0% vs 72.6%), and had more comorbidities. More patients in the nonischemic group were able to have their devices explanted after left ventricular recovery (5.9% vs 2.0%; P=0.02). More patients in the ischemic group had gastrointestinal bleeding (31.2% vs 22.6%; P=0.03), particularly from arteriovenous malformations (20.7% vs 11.9%; P=0.006) and ulcers (16.4% vs 9.3%; P=0.01). Kaplan-Meier analysis revealed no difference in overall survival between groups (P=0.24). Older age, previous sternotomy, higher total bilirubin level, and concomitant procedures during device implantation independently predicted death (P ≤0.03), whereas cause of heart failure did not (P=0.08). Despite the similarity in overall survival between groups, ischemic cardiomyopathy was associated with more frequent gastrointestinal bleeding. This information may help guide the care of patients with ischemic cardiomyopathy who receive continuous-flow left ventricular assist device support.

Background Despite technological advancements, pump durability and pump-related complications continue to affect and adversely impact the lives of patients with end-stage heart failure on left ventricular assist device (LVAD) support. In an attempt to avoid recurrent LVAD-related complications, there may be circumstances where it is clinically advantageous to exchange a patient's device from HeartMate II to HeartWare HVAD. However, there is a paucity of data that describes the safety and feasibility of such an approach. Objective We present the largest single-center series of HeartMate II (HMII) to HeartWare (HVAD) device exchanges. Methods A retrospective review of 11 patients who underwent HMII to HVAD exchange from 2012 to 2017 was conducted to evaluate patient characteristics, incidence of postoperative complications, and survival. Results Eleven male patients (mean age 55 ± 14.4 years) underwent HMII to HVAD device exchange. One patient expired on postoperative day 7 secondary to sepsis. One patient was lost-to-follow-up after 23 months. An additional three patients died at 5, 7, and 24 months. Mean follow-up after device exchange was 1555 ± 311 days for the remaining six patients. None of the 11 study patients underwent LVAD explant, further device exchange, or heart transplant. Conclusion Exchange of an HMII LVAD to an HVAD can be performed safely with acceptable perioperative morbidity and mortality.

Left ventricular assist device (LVAD) implantations have traditionally been approached through a full median sternotomy (FS). Recently, a minimally invasive left thoracotomy (LT) approach has been popularized. This study sought to compare the outcomes of FS and LT patients post-primary LVAD implantation and post-subsequent heart transplant (HT). This was a single-center retrospective study. 83 patients who underwent primary centrifugal durable LVAD implantation from January 2014 to June 2018 were included (FS, n = 41; LT, n = 42). 41 patients had a subsequent HT (FS, n = 19; LT, n = 22). Pre-operative patient demographics, intraoperative variables, post-operative 1-year survival, length of hospital stay, complications, and outcomes for LVAD implantation and following HT were analyzed. Intraoperative data showed that the LT group had a 23.4% longer mean LVAD implant surgical time (p 0.01). One-year post-LVAD survival was similar between the two groups (p = 0.05). Complication rates, with the exception of the rate of hemorrhagic stroke (p = 0.04) post-LVAD implant were similar. One-year survival post-HT was similar between groups (p = 0.35). Complication rates and mean length of hospital stay were also similar (p = 1.0) post-HT. Our study demonstrated that LT approach does not negatively affect post-LVAD implantation or post-HT outcomes. Further, larger studies may determine more detailed effects of LT approach.

The standard approach for implanting an HVAD left ventricular assist device (LVAD) is performing a median sternotomy and sewing the outflow graft to the ascending aorta. However, in patients with sternal comorbidities, it may be advantageous to use a sternum-sparing approach. We retrospectively studied eight patients who underwent HVAD implantation for destination therapy via a left subcostal or fifth/sixth intercostal space incision. With this procedure, the outflow graft was sewed to the descending aorta. Ninety-day and one-year survival rates were 87.5% and 75%, respectively. Two patients (25%) died during the perioperative period: one from multisystem organ failure and the other from unrelated causes. We adjusted the HVAD speed to open the aortic valve once every three to four beats. Compared with other continuous-flow LVAD implantations performed at our institution during the study period (n = 437), this technique resulted in shorter bypass times and a lower incidence of infection; it was not associated with an increased incidence of heart failure, aortic root thrombosis, pump thrombosis, progression of aortic insufficiency, or ischemic neurologic dysfunction. Our findings suggest that a sternum-sparing approach for HVAD implantation is feasible and may be a safe option in patients with serious comorbidities that preclude the use of traditional implantation techniques.

The use of continuous-flow left ventricular assist devices (CF-LVADs) to treat advanced heart failure is increasing. Although risk scores, such as Model for End-Stage Liver Disease and the HeartMate II Risk Score, require the use of the international normalized ratio, many patients are on anticoagulation before CF-LVAD implantation. This study evaluated the ability of the Model of End-Stage Liver Disease-eXcluding International Normalized Ratio (MELD-XI) scoring system to predict clinical outcomes in patients with advanced heart failure who undergo CF-LVAD implantation.A single-center retrospective review was performed of 524 patients who were implanted with the HeartMate II LVAD (Thoratec Corporation, Pleasanton, CA) or the HeartWare HVAD (HeartWare International Inc, Framingham, MA) between 2004 and 2016. Patients were stratified into two cohorts: those with a MELD-XI score of less than 14 (n = 301) and 14 or higher (n = 223).Patients with the higher-risk MELD-XI score of 14 or higher demonstrated lower survival rates at 1, 3, 6, 12, and 24 months (p0.001 for all) and increased risk of early right heart failure and infections compared with patients with MELD-XI score of less than 14. MELD-XI was not significantly inferior at predicting 90-day mortality compared with the HeartMate II Risk Score (p = 0.92). Patients with elevated MELD-XI scores at follow-up demonstrated higher rates of mortality.These findings suggest that a MELD-XI score of 14 or higher was associated with a higher postoperative mortality rate than that seen in patients with a lower MELD-XI score. The MELD-XI scoring system can be used to predict outcomes in patients with advanced heart failure who undergo CF-LVAD implantation.

An increasing number of children with congenital heart disease are surviving into adulthood and subsequently developing end-stage heart failure. Two example populations are adults who have been previously operated on for congenitally corrected transposition of the great arteries (CCTGA) and transposition of the great arteries (TGA). Implantation of a continuous flow left ventricular assist device (CF-LVAD) in these patients can present unusual anatomical and physiologic challenges. In this report, we describe outcomes of CF-LVAD implantation in three such patients. These cases demonstrate the feasibility of implanting a CF-LVAD in patients who have undergone surgery for CCTGA and/or TGA.

Continuous-flow left ventricular assist devices (CF-LVADs) are increasingly being used to treat advanced, refractory chronic heart failure. Herein, we sought to determine the incidence of postoperative acute kidney injury (AKI) in axial-flow (HeartMate II; HM-II) and centrifugal-flow (HVAD) CF-LVAD recipients, as well as the effect of AKI on mortality. The study cohort comprised 520 patients who received a HM-II (n = 398) or HVAD (n = 122) at our center between November 2003 and March 2016. Their records were reviewed to determine the incidence of RIFLE-defined AKI after LVAD implantation. We compared the perioperative characteristics, postoperative complications, and survival rates of the patients with and without AKI and differentiated the outcomes based on device type (HM-II or HVAD). Seventy-five patients (14.4%) developed AKI postoperatively. Patients with AKI after LVAD implantation had significantly reduced survival compared to patients without AKI (p = 0.01). Cox proportional hazards models showed that AKI was a significant independent predictor of mortality (HR = 1.54, p = 0.03). Preoperative mechanical circulatory support and prolonged cardiopulmonary bypass time were independent predictors of AKI. The incidence of AKI was similar for HM-II and HVAD recipients (p = 0.25). There was no significant difference in AKI rates for the HM-II and HVAD recipients. Developing AKI adversely affected survival.

Implanting short-term mechanical circulatory support (MCS) devices as a bridge-to-decision is increasingly popular. However, outcomes have not been well studied in patients who receive short-term MCS before receiving long-term left ventricular assist device (LVAD) support. We analyzed outcomes in our single-center experience with long-term continuous-flow (CF)-LVAD recipients with pre-implantation short-term MCS. From November 2003 through March 2016, 526 patients (mean age, 54.7 ± 13.5 years) with chronic heart failure (mean ejection fraction, 21.7 ± 3.6%) underwent implantation of either the HeartMate II (n = 403) or the HeartWare device (n = 123). Before implantation, 269 patients received short-term MCS with the TandemHeart, the Impella 2.5/5.0, an intra-aortic balloon pump (IABP), venoarterial extracorporeal membrane oxygenation (VA-ECMO), or the CentriMag. The short-term MCS patients were compared with the CF-LVAD-only patients regarding preoperative demographics, incidence of postoperative complications, and long-term survival. The 269 patients received the following short-term MCS devices: 57 TandemHeart, 27 Impella, 172 IABP, 12 VA-ECMO, and 1 CentriMag. Survival at 30 days, 6 months, 1 year, and 2 years was 94.2, 87.2, 79.4, and 72.4%, respectively, for CF-LVAD-only patients versus 91.0, 78.1, 73.4, and 65.6%, respectively, for short-term MCS + CF-LVAD patients (P = 0.17). Within the short-term MCS group, survival at 24 months was poorest for patients supported with VA-ECMO or the TandemHeart (P = 0.03 for both), and survival across all four time points was poorest for patients supported with VA-ECMO (P = 0.02). Short-term MCS was not an independent predictor of mortality in multivariate Cox regression models (hazard ratio = 1.12, 95% confidence interval = 0.84-1.49, P = 0.43). In conclusion, we found that using short-term MCS therapy-except for VA-ECMO-as a bridge to long-term CF-LVAD support was not associated with poorer survival.

Postoperative right-sided heart failure (RHF) is a common complication after continuous-flow left ventricular assist device implantation. Studies have examined RHF in the perioperative period, but few have assessed late-onset RHF. We analyzed the incidence of early and late RHF in patients with HeartMate II and HeartWare left ventricular assist devices and associated morbidity, mortality, and independent predictors of RHF. We retrospectively analyzed records of 526 patients with chronic heart failure who underwent continuous-flow left ventricular assist device implantation; 147 (27.9%) developed RHF (early RHF, n = 87, 16.5%; late RHF, n = 74, 14.4%). We examined demographics, postoperative complications, and long-term survival rate. Patients with RHF or late RHF had higher mortality (p

The purpose of this study was to analyze the effect of obesity on outcomes after continuous-flow left ventricular assist device (CF-LVAD) implantation. A single-center retrospective analysis was performed on 526 chronic heart failure patients who were implanted with the HeartMate II CF-LVAD (n = 403) or HeartWare HVAD (n = 123) between November 2003 and March 2016. Patients were stratified into 4 groups based on BMI: underweight ( 30 kg/m2, n = 153, 33.5%). The underweight group was excluded because of its small sample size. Records were reviewed to determine the incidence of postoperative complications and survival. Survival at 1, 6, 12, and 24 months were similar among normal-weight (91.3, 84.4, 76.3, and 67.6%), overweight (90.4, 80.8, 76.5, and 69.6%), and obese patients (90.7, 74.7, 65.3, and 61.3%, p = 0.24). Additionally, obesity was not a significant predictor of mortality in Cox proportional hazard models (hazard ratio 0.98, 95% confidence interval 0.766–1.277, p = 0.13). These findings suggest that appropriately selected obese patients receive similar survival benefit from CF-LVADs compared to non-obese patients, and obesity should not serve as a contraindication to CF-LVAD implantation.

Malnutrition has been associated with an increased risk of morbidity and mortality in patients who undergo cardiac surgery. However, many measurements of malnutrition have been inadequate prognostic markers. In this study, we sought to determine whether low preoperative serum prealbumin level was associated with morbidity and mortality in patients who underwent continuous-flow left ventricular assist device (CF-LVAD) implantation. From November 2003 to March 2016, 526 patients with chronic heart failure underwent implantation of a CF-LVAD (HeartMate II, n = 403; HeartWare HVAD, n = 123). Our cohort comprised the 317 CF-LVAD recipients whose records included the preoperative serum prealbumin level. These patients were divided into 2 groups: those with a normal preoperative serum prealbumin level (17 g/dL) and those with hypoprealbuminemia (≤17 g/dL). These groups were then compared with regard to preoperative demographics, incidence of postoperative complications, long-term survival rate, and cause of death. Kaplan-Meier survival analysis revealed that patients with a low preoperative prealbumin level had significantly decreased survival rates at 1, 6, 12, and 24 months (p 0.001) after CF-LVAD implantation and higher overall mortality (p = 0.04) than the patients with a normal prealbumin level, and that exacerbated heart failure made up the majority of this difference within the first 6 months. However, we found no significant correlations between low prealbumin level and postoperative complications. In conclusion, our findings demonstrate that preoperative serum prealbumin levels predict patient outcomes after CF-LVAD implantation.

Left ventricular assist devices (LVADs) have become a preferred treatment option for patients with end-stage heart failure when used as a bridge to transplant or as a destination therapy. However, the association between small body size and postoperative outcomes for continuous-flow (CF) LVAD recipients is still being studied. We sought to determine whether body surface area (BSA) is associated with patient outcomes after CF-LVAD implantation. The study cohort of our single-center, retrospective review consisted of all patients (n = 526) who underwent CF-LVAD implantation (n = 403 HeartMate II, n = 123 HeartWare) between November 2003 and March 2016 regardless of indication. Patients were stratified into 2 cohorts according to their BSA measurements: small BSA (

BACKGROUND Study findings have been inconsistent regarding whether a concomitant tricuspid valve replacement or repair performed concurrently with continuous-flow left ventricular assist device (CF-LVAD) implantation has additive clinical benefit in patients with severe tricuspid valve regurgitation (TR). AIM OF STUDY To determine the effect of performing a concomitant tricuspid valve procedure (TVP) at the time of CF-LVAD implantation on patient outcomes. METHODS We retrospectively reviewed our single-institution experience in 526 patients who underwent primary implantation of a CF-LVAD between November 2003 and March 2016. We identified 59 (11.2%) patients who had severe TR at the time of implantation and analyzed the effect of performing a concomitant TVP at the time of CF-LVAD implantation on the rate of survival, incidence of postoperative right heart failure (RHF), recurrence of TR, and incidence of 30-day readmission. RESULTS We did not observe a significant difference in the overall survival rate (P = .51), incidence of postoperative RHF (P = .26), or recurrence of TR (P = .73) between patients with severe TR who underwent a TVP and those who did not at the time of CF-LVAD implantation. However, the incidence of 30-day readmission was significantly lower in patients who underwent a TVP than in those who did not (P = .002). CONCLUSIONS Performing a concomitant TVP at the time of CF-LVAD implantation did not improve patient outcomes but reduced the incidence of 30-day readmission.

In this study, we sought to determine the accuracy of several critical care risk scores for predicting survival of Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profile 1 patients after continuous-flow left ventricular assist device (CF-LVAD) placement. We retrospectively analyzed the records of 605 patients who underwent CF-LVAD implantation between 2003 and 2016. We calculated the preoperative HeartMate II Risk Score (HMRS) and preoperative Right Ventricular Failure Risk Score (RVFRS) and the following risk scores for postoperative days 1-5: HMRS, RVFRS, Model for End-stage Liver Disease (MELD), MELD-eXcluding International Normalized Ratio, Post Cardiac Surgery (POCAS) risk score, Sequential Organ Failure Assessment (SOFA) risk score, and Acute Physiology and Chronic Health Evaluation III. The preoperative scores and the postoperative day 1, 5-day mean, and 5-day maximum scores were entered into a receiver operating characteristic curve analysis to examine accuracy for predicting 30-day, 90-day, and 1-year survival. The mean POCAS score was the best predictor of 30-day and 90-day survival (area under the curve [AUC] = 0.869 and 0.816). The postoperative mean RVFRS was the best predictor of 1-year survival (AUC = 0.7908). The postoperative maximum and mean RVFRS and HMRS were more accurate than the preoperative scores. Both of these risk score measurements of acuity in the postoperative intensive care unit setting help predict early mortality after LVAD implantation.

The frozen elephant trunk technique's safety regarding spinal cord ischemia has been questioned. We used a meta-analysis to determine the rates of adverse neurologic events and mortality.We searched PubMed/Medline, Embase, Scopus, and Cochrane databases (inception to April 2018) to identify studies of neurologic events after the frozen elephant trunk procedure. Separate meta-analyses were conducted with random-effects models to assess frozen elephant trunk associations with spinal cord ischemia, stroke, operative mortality, and all adverse events combined. Subgroup analyses compared outcomes in patients with acute versus nonacute type A dissection and aneurysm and with different extents of coverage.Thirty-five studies (total N = 3154) met inclusion criteria. The pooled rates of the outcomes of interest were 4.7% (95% confidence interval, 3.5-6.2) for spinal cord ischemia, 7.6% (95% confidence interval, 5.0-11.5) for stroke, and 8.8% (95% confidence interval, 7.0-10.9) for operative mortality. The spinal cord ischemia event rate was higher with stent length 15 cm or greater or coverage to T8 or beyond than with stent length of 10 cm (11.6% vs 2.5%, P .001). Adverse event rates in patients with acute type A aortic dissection versus nonacute dissection or aneurysm were as follows: mortality 9.2% versus 7.6% (P = .46), stroke 9.3% versus 6.6% (P = .51), and overall adverse events 22.0% versus 16.5% (P = .41).As the frozen elephant trunk procedure becomes more popular, accurate data regarding outcomes are vital. We associated the frozen elephant trunk technique with (nonsignificantly) more adverse events overall in acute type A dissection cases. Stent length of 10 cm was associated with significantly less risk of spinal cord ischemia. Using a stent 15 cm or greater or coverage extending to T8 or farther should be avoided.

OBJECTIVES Some patients who undergo continuous-flow left ventricular assist device (CF-LVAD) implantation require concomitant procedures that can be performed with or without cardiac arrest under aortic cross-clamping (AXC). Procedures normally performed with cardiac arrest are sometimes avoided or performed without cardiac arrest because it may be detrimental to right heart function. However, the effects of cardiac arrest on patients with advanced heart failure necessitating CF-LVAD support have not been thoroughly studied. We examined our single-centre experience to determine whether cardiac arrest during CF-LVAD implantation was associated with worse patient outcomes. METHODS From November 2003 to March 2016, a total of 526 patients with chronic end-stage heart failure underwent primary CF-LVAD implantation. Preoperative demographics, postoperative complications and mortality rates were compared between patients who required cardiac arrest with AXC (n = 50) and those who did not (n = 476). RESULTS The most frequently performed procedure requiring AXC was aortic valve closure (n = 23, 26.1%). Although the AXC group had longer cardiopulmonary bypass times (P CONCLUSIONS Cardiac arrest with AXC during CF-LVAD implantation did not negatively affect long-term survival or the incidence of right ventricular failure or stroke. These findings should be considered in deciding surgical strategies. Additional investigation may be warranted to further understand the effects of cardiac arrest during LVAD implantation.

BACKGROUND Left ventricular assist devices (LVADs) are being used more frequently for treating refractory, advanced heart failure. However, infection remains a frequent complication. In this study, we analyzed the incidence of severe infections in LVAD recipients to determine its impact on survival. METHODS From May 2009 through March 2016, 437 patients with advanced heart failure underwent implantation of a continuous-flow LVAD (n = 314, HeartMate II LVAD [Abbott Laboratories, Abbott Park, IL]; n = 123 HeartWare HVAD [Medtronic, Minneapolis, MN]). We analyzed the rate of severe device infection requiring surgical intervention or involving sepsis and the impact of severe infection on outcomes in patients on long-term LVAD support. RESULTS Infection occurred in 244 patients (HeartMate II, n = 186; HVAD, n = 58); severe infections developed in 160 patients (HeartMate II, n = 119; HVAD, n = 41). HeartMate II recipients had 344 severe infection events (0.63 events per patient-year [EPPY]), whereas HeartWare recipients had 89 severe infection events (0.42 EPPY; P = 0.047). HeartMate II recipients had a higher incidence of pump infections (P

Purpose Preoptimizing the hemodynamics and volume status prior to heart transplant is essential for the outcome. Temporary mechanical circulatory support (MCS) has been expanding especially after recent changes to the UNOS donor heart allocation criteria. The aim of our study is to evaluate the incidence of various MCS device use and outcomes of preoperative MCS to heart transplantation. Methods We performed a retrospective analysis using the UNOS Resistry of all adult heart transplant recipients from 1997 to 2017 comparing various MCS device regarding days to discharge, hospital survival and 2 year survival rates. Patient who did not have MCS preoperatively were analyzed as base line survival. A multivariate Cox proportional hazard analysis was performed, adjusted for recipient hemodynamics, age, and various MCS devices. Kaplan Meier survival analysis and log-rank test were used to compare survival. Results There were 78,181 patient included in our study. Devices used for bridging included HeartMate II (N = 6,053), HVAD (N = 2,195), Syncardia (N = 322), Impella (N = 72), TandemHeart (N = 18), CentriMag (N = 153), ECMO (N = 1,513), and IABP (N = 2,509). Bridging with HM2 (HR 0.74, p Conclusion Our study showed BTT MCS can provide comparable clinical outcomes to primary OHT. However, ECMO was independent predictors of mortality after transplantion. This finding may guide the decision on heart transplant candidacy and timing of heart transplant.

Background: Advanced age is a relative contraindication for heart transplantation, but no age cutoff has been defined for patients receiving mechanical circulatory support. Methods: Between November 1, 2003 and November 1, 2012, we implanted the HeartMate II (HMII) left ventricular assist device (LVAD) in 319 patients. One hundred seven patients (89 men, 18 women) were over 60 years old (mean, 66 ± 4 years; range, 61-78 years) and received the HMII as a bridge to transplantation (n = 45) or as destination therapy (n = 62). We evaluated their experience by performing a retrospective analysis. Results: Seventy-two patients had ischemic cardiomyopathy, and 34 had idiopathic cardiomyopathy. Three patients (2.8%) already had a HeartMate XVE LVAD; 54 (50.5%) were receiving intra-aortic balloon pump support; 52 (48.6%) had undergone a previous cardiac procedure; and 9 (8.4%) had received renal replacement therapy (RRT) (continuous venovenous hemofiltration, hemodialysis, or both) before HMII implantation. The median duration of HMII support was 313 days (range, 1-3339 days). After device implantation, 36 patients (33.6%) had gastrointestinal bleeding, 24 (23%) required RRT, 18 (17.5%) had ventricular arrhythmias, and 24 (22.4%) had LVAD-related infections, and 9 (8.4%) had right ventricular failure requiring mechanical support, and 28 (26.2%) had neurologic complications. The actual survival rate was 69% at 6 months, 63% at 1 year, and 54% at 2 years. Eighty-one patients died; 9 are still receiving HMII support; and 17 are alive after heart transplantation. Conclusions: Older patients can benefit from LVAD therapy, and advanced age should not preclude LVAD implantation.

The effect of performing a concomitant mitral valve procedure (MVP) during continuous-flow left ventricular assist device (CF-LVAD) implantation has been reported for patients with moderate-to-severe mitral regurgitation (MR), but moderate MR is less of a clinical concern for CF-LVAD patients. There is a paucity of reports focusing on patients with severe MR. Thus, the purpose of this study was to analyze the effect of performing a concomitant MVP during CF-LVAD implantation in patients with severe preoperative MR. Between November 2003 and March 2016, 526 patients underwent primary implantation of a CF-LVAD at our center. Patients with severe MR who underwent a concomitant MVP were compared to those who did not in regard to overall survival, perioperative complications, postoperative echocardiography data, bridge-to-transplantation success, and CF-LVAD explantation. Of the 108 patients with severe MR, 26 underwent a concomitant MVP and 82 did not. These groups showed no difference in survival (p = 0.61). Additionally, the two groups had similar rates of postoperative right heart failure (p = 0.69) and readmissions (p = 0.42). The 24-month follow-up echocardiography results were also similar. Furthermore, the groups showed no difference in bridge-to-cardiac transplantation success (30.0% vs 25.0%, p = 0.80) or CF-LVAD explantation rates (0.0% vs 0.0%. p = 1.0). Our findings suggest that patients with severe MR who undergo a MVP during CF-LVAD implantation do not have superior outcomes to those who do not. However, assessments of other outcomes may show some benefits to performing concomitant MVPs.

BACKGROUND We performed a single-center retrospective analysis to determine whether preoperative serum albumin levels were associated with postoperative adverse events and short- and long-term survival in patients who underwent continuous-flow left ventricular assist device (CF-LVAD) implantation. METHODS From November 2003 through March 2016, 526 patients underwent CF-LVAD implantation. Patients whose preoperative serum albumin level was normal (≥3.5 g/dL) were compared to patients with preoperative hypoalbuminemia (

Although preoperative atrial fibrillation (AF) is common in patients undergoing continuous-flow left ventricular assist device (CF-LVAD) implantation, how AF affects outcomes remains unclear. We analyzed our single-center experience with CF-LVAD implantation to determine whether preoperative AF was associated with inferior outcomes. From November 2003 through March 2016, 526 patients with chronic heart failure underwent implantation with the HeartMate II (HMII; n = 403) or HeartWare VAD (HVAD; n = 123). We identified 229 patients (165 HMII, 65 HVAD) who had preoperative AF and compared them with non-preoperative AF patients regarding the incidence of postoperative stroke, as well as long-term survival. After implantation, 139 patients had a stroke (78 non-preoperative AF patients [26.2%], 61 preoperative AF patients [26.6%]; p = 0.84). The rate of events per patient-year was 0.19 in non-preoperative AF patients and 0.22 in preoperative AF patients (p = 0.84). Survival was not significantly different between the two groups (p = 0.60). In Cox regression, preoperative AF was not associated with postoperative stroke (odds ratio: 1.13; 95% confidence interval [CI]: 0.74-1.74; p = 0.55) or survival (hazard ratio: 0.93; 95% CI: 0.71-1.25; p = 0.66). We conclude that in CF-LVAD recipients, preoperative AF did not diminish perioperative or long-term survival or increase the risk of postoperative stroke. These findings suggest that performing concomitant AF ablation during CF-LVAD implantation may be unnecessary.

Purpose Patients with advanced heart failure and cardiorenal syndrome can experience significantly elevation in blood urea nitrogen (BUN) levels. We evaluated the impact of preoperative elevated BUN levels on bleeding and survival in patients who underwent continuous flow - left ventricular assist device (CF-LVAD) implantation. Methods We performed a retrospective review of 737 patients who underwent implantation of CF-LVADs from December 1999 through August 2017 at our center. Preoperative hemodynamics, perioperative characteristics, and postoperative outcomes were compared between patients with BUN ≥60 mmol/L and those Results Of the 664 patients included in the study (73 were excluded due to incomplete data), 53 patients had a BUN ≥60 mmol/L (mean: 83±28) and 611 patients had a BUN Conclusion Preoperative elevation in BUN above 60 mmol/L was associated with higher mortality. Additional studies are warranted to determine whether preoperative optimization of the uremia with medical therapy and/or dialysis can impact the increased risk of mortality.

Implanting short-term mechanical circulatory support (MCS) devices as a bridge-to-decision is increasingly popular. However, outcomes have not been well studied in patients who receive short-term MCS before receiving long-term left ventricular assist device (LVAD) support. We analyzed outcomes in our single-center experience with long-term continuous-flow (CF)-LVAD recipients with pre-implantation short-term MCS. From November 2003 through March 2016, 526 patients (mean age, 54.7 ± 13.5 years) with chronic heart failure (mean ejection fraction, 21.7 ± 3.6%) underwent implantation of either the HeartMate II (n = 403) or the HeartWare device (n = 123). Before implantation, 269 patients received short-term MCS with the TandemHeart, the Impella 2.5/5.0, an intra-aortic balloon pump (IABP), venoarterial extracorporeal membrane oxygenation (VA-ECMO), or the CentriMag. The short-term MCS patients were compared with the CF-LVAD-only patients regarding preoperative demographics, incidence of postoperative complications, and long-term survival. The 269 patients received the following short-term MCS devices: 57 TandemHeart, 27 Impella, 172 IABP, 12 VA-ECMO, and 1 CentriMag. Survival at 30 days, 6 months, 1 year, and 2 years was 94.2, 87.2, 79.4, and 72.4%, respectively, for CF-LVAD-only patients versus 91.0, 78.1, 73.4, and 65.6%, respectively, for short-term MCS + CF-LVAD patients (P = 0.17). Within the short-term MCS group, survival at 24 months was poorest for patients supported with VA-ECMO or the TandemHeart (P = 0.03 for both), and survival across all four time points was poorest for patients supported with VA-ECMO (P = 0.02). Short-term MCS was not an independent predictor of mortality in multivariate Cox regression models (hazard ratio = 1.12, 95% confidence interval = 0.84-1.49, P = 0.43). In conclusion, we found that using short-term MCS therapy-except for VA-ECMO-as a bridge to long-term CF-LVAD support was not associated with poorer survival.

Objective The effects of having a lower left ventricular end-diastolic dimension before HeartMate II (Thoratec Corp, Pleasanton, Calif) left ventricular assist device implantation remain unclear. We analyzed our single-center data on HeartMate II implantation to determine whether having a lower left ventricular end-diastolic dimension preoperatively was associated with inferior outcomes. Methods From November 2003 to March 2016, 393 patients with chronic heart failure underwent primary HeartMate II implantation. We compared the preoperative left ventricular end-diastolic dimension and associated survival outcomes of these patients to determine the left ventricular end-diastolic dimension cutoff for worse overall survival. Then, we compared the preoperative demographics, stroke rate, and mortality of patients with a left ventricular end-diastolic dimension above the cutoff for worse survival with those of patients with a left ventricular end-diastolic dimension below the cutoff. Results A Cox multivariate regression model showed that low left ventricular end-diastolic dimension was an independent predictor of mortality (hazard ratio, 1.49; P = .02). The Contal and O'Quigley method showed that overall survival postimplantation was decreased in patients with a left ventricular end-diastolic dimension less than 6.0 cm (n = 91). Kaplan–Meier analysis confirmed that the left ventricular end-diastolic dimension less than 6.0 cm group had lower overall survival than the left ventricular end-diastolic dimension 6.0 cm or greater group (P = .04). Furthermore, a competing-risk analysis showed that postoperative stroke was more common in the left ventricular end-diastolic dimension less than 6.0 cm group than in the left ventricular end-diastolic dimension 6.0 cm or greater group (P Conclusions Overall survival was decreased and postoperative stroke was increased in HeartMate II recipients with a preoperative left ventricular end-diastolic dimension less than 6.0 cm. Future research should determine the left ventricular end-diastolic dimension cutoff values for safely implanting other support devices, and device designs should be improved to better accommodate the needs of patients with a limited left ventricle size.

We previously reported a series of 5 patients with advanced heart failure and aortic insufficiency (AI) who underwent concomitant left ventricular outflow tract (LVOT) closure at the time of continuous-flow left ventricular assist device (CF-LVAD) implantation. Although this technique of treating AI has been shown to be effective in the short term, its long-term durability has not been well studied. Here, we report the long-term outcomes of two patients with severe AI who underwent LVOT closure at the time of CF-LVAD implantation. Each of the two patients survived for more than 6 years without any complications related to LVOT closure.

Objective Long-term support with continuous-flow left ventricular assist devices (CF-LVADs) has improved the outcomes of patients with end-stage heart failure. However, valve disease management in patients who undergo CF-LVAD implantation remains controversial. The aim of this study was to assess our single-center experience with patients who underwent a concomitant valve procedure during implantation of a CF-LVAD. Methods From November 2003 through March 2016, 526 patients underwent primary CF-LVAD implantation with a HeartMate II (St Jude Inc, St Paul, Minn; n = 403) or HeartWare (Medtronic, Minneapolis, Minn; n = 123) device at our center. Of those, 91 underwent a concomitant valve procedure during implantation (CF-LVAD+valve procedure group), whereas 435 did not (CF-LVAD–only group). We compared preoperative characteristics and short-term and mid-term survival rates between these groups. Results The concomitant valve procedures performed included 13 tricuspid valve repairs, 19 aortic valve repairs or replacements, 30 mitral valve repairs or replacements, and 29 double valve repairs or replacements. Survival rates at 1 month, 6 months, 12 months, and 24 months were 90.3%, 81.4%, 74.9%, and 67.4%, respectively, for the CF-LVAD–only group and 89.0%, 75.8%, 70.3%, and 65.9%, respectively, for the CF-LVAD+valve procedure group (P = .55). The results of Cox regression multivariable modeling showed that performing a concomitant valve procedure was not an independent predictor of mortality (hazard ratio, 1.29; 95% confidence interval, 0.96-1.74; P = .08). Conclusions In our experience, performing a concomitant valve procedure during CF-LVAD implantation was not associated with an increased mortality rate. The decision to perform a concomitant valve procedure should be made primarily on the basis of clinical indications for the procedure.

Purpose Continuous flow left ventricular assist device (CF-LVAD) support has been associated with high rates of gastrointestinal bleeding (GIB). We analyzed the ability of the R2CHA2DS2 VASc scoring system to predict GIB in patients on CF-LVAD support. Methods We performed a retrospective review of 526 patients who underwent implantation of CF-LVADs from November 2003 through March 2016 at our center. The R2 CHA2DS2 VASc score was calculated preoperatively for each patient, and logistic regression analysis and receiver operating characteristic (ROC) curve analysis were performed to determine whether this risk score predicted GIB. Additional analyses were performed using the R2 CHA2DS2 VASc score to identify etiologies and locations of GIB. Results R2CHA2DS2 VASc score was calculated for 519 patients; 7 patients were excluded due to incomplete data. Average score was 5.1±1.4 (Figure). A total of 218 GIB event occurred in 140 patients; 48 experienced a recurrent GIB. Median time to GIB event was 78 days (interquartile range = 36.5-2298.75 days). The most common etiology was atriovenous malformations (72 events in 50 patients). The R2 CHA2DS2 VASc score successfully predicted GIB (Odds ratio [OR]=1.4, p=0.001) and was especially significant for GIB from ulcers (OR=1.4, p=0.002) and AVMs (OR=1.5, p=0.001) in the stomach (OR=1.3, p=0.004) and duodenum (OR=1.5, p=0.02; Table). ROC curve analysis resulted in an area under the curve of 0.63. Conclusion The R2 CHA2DS2 VASc risk score accurately predicted GIB events in CF-LVAD recipients from AVMs and ulcers in the stomach and duodenum. This may be useful in the selection and management of patients being considered for LVAD implantation.

Purpose Continuous flow left ventricular assist device (CF-LVAD) support has been associated with gastrointestinal bleeding (GIB), primarily from arteriovenous malformations or ulcers, and exacerbated by the requirement for anticoagulation. In this report, we explore whether GIB persisted after heart transplant in patients who experienced GIB events while on CF-LVAD support. Methods We performed a retrospective review of 701 patients who underwent implantation of CF-LVADs from August 2002 through August 2017 at our center, and identified patients who underwent CF-LVAD implantation as a Bridge-to-Transplant, experienced at least one GIB event during CF-LVAD support, and were successfully bridged to heart transplantation. We evaluated the incidence of GIB events in these patients after heart transplantation. Results A total of 46 heart transplant recipients fit the inclusion criteria. There were a total of 63 total GIB events while on CF-LVAD support. Locations of GIB events included esophagus (N=3), stomach (N=21), duodenum (N=7), jejunum (N=3), small intestine not-otherwise-specified (N=12), colon (N=14), and rectum (N=3). Etiologies included gastritis (N=10), ulcer (N=11), arteriovenous malformation (N=13), angiodysplasia (N=3), polyp (N=2), diverticulosis (N=8), and Mallory Wiess tear (N=2). Mean LVAD support time was 1.4±1.5 years (65.4 cumulative patient-years). Mean follow-up time after transplantation was 4.0±3.5 years (183.3 cumulative patient-years after transplantation). There was only 1 GIB event after heart transplantation (events per patient-year: 0.005). The etiology was non-specific acute colitis in a patient who had prior GIB from a gastric ulcer while on LVAD therapy. Time from transplant to GIB event was 3.9 years. The patient was taking aspirin 81mg daily at the time of GIB. Conclusion GIB during CF-LVAD therapy did not persist after heart transplantation. This may be due to restoration of pulsatile flow. Introduction of a greater degree of pulsatility into LVAD flow technology may improve the incidence of GIB while on CF-LVAD support.

Purpose Recent studies involving partial-support ventricular assist device (VADs) have suggested INTERMACS Profiles may be used as a means of identifying patients with less severe heart failure who require lower flow rates. We explore which preoperative factors are predictive of continuous-flow left VAD (CF-LVAD) flow requirements at discharge. Methods Retrospective review of 206 patients who underwent primary implantation of CF-LVAD from May 2013 through August 2017 at our center and survived to discharge. We performed step-wise multiple linear regression analysis on preoperative factors to identify factors that predicted CF-LVAD flow rates at the time of discharge. Results Of the 206 patients in our study, 27 (13.1%) were INTERMACS Profile 1, 53 (25.7%) were Profile 2, 95 (46.1%) were Profile 3, 14 were Profile 4, and 17 (6.8%) were Profile 5-7. Mean flow rates at discharge were 5.3±1.3, 5.3±1.6, 4.9±1.3, 5.3±1.2, and 5.8±1.0 L/min, respectively. Linear regression analysis showed INTERMACS Profile was not correlated with LVAD flow (p=0.73). Age (Regression Coefficient [RC] = -0.03, p=0.009), body surface area (BSA; RC = 0.23, p=0.03), creatinine (RC = 0.40, p=0.02) and mean right atrial pressure (RC = 0.05, p=0.02) were significantly correlated with higher flow rates (Table). Conclusion INTERMACS Profile was not a predictor of required flow rates for patients on CF-LVAD support at the time of discharge. Younger age, higher BSA, and preoperative creatinine and mean right atrial pressure predicted greater flow requirements. Further studies are warranted to devise predictive models of CF-LVAD flow requirements.