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A 55-year-old patient was found to have complete heart block during preoperative assessment. Cardiac magnetic resonance imaging revealed an interatrial mass suggestive of primary cardiac tumor. Extensive evaluation including intracardiac biopsy and finally open resection revealed lipomatous hypertrophy masquerading as tumor. (Level of Difficulty: Intermediate.), Graphical abstract

Shared decision making with patients in advanced heart failure is critical when making decisions on therapies such as left ventricular assist device implantation and cardiac transplantation. We describe a case wherein the risks of coronavirus disease-2019 affected the decision of a patient regarding proceeding with cardiac transplantation. (Level of Difficulty: Beginner.).

In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have pump thrombosis or nondisabling stroke than were patients treated with a mechanical-bearing axial-flow left ventricular assist device.We randomly assigned patients with advanced heart failure to receive either the centrifugal-flow pump or the axial-flow pump irrespective of the intended goal of use (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at 2 years.This final analysis included 1028 enrolled patients: 516 in the centrifugal-flow pump group and 512 in the axial-flow pump group. In the analysis of the primary end point, 397 patients (76.9%) in the centrifugal-flow pump group, as compared with 332 (64.8%) in the axial-flow pump group, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years (relative risk, 0.84; 95% confidence interval [CI], 0.78 to 0.91; P0.001 for superiority). Pump replacement was less common in the centrifugal-flow pump group than in the axial-flow pump group (12 patients [2.3%] vs. 57 patients [11.3%]; relative risk, 0.21; 95% CI, 0.11 to 0.38; P0.001). The numbers of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in the centrifugal-flow pump group than in the axial-flow pump group.Among patients with advanced heart failure, a fully magnetically levitated centrifugal-flow left ventricular assist device was associated with less frequent need for pump replacement than an axial-flow device and was superior with respect to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.).

Background: The MOMENTUM 3 study (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) has demonstrated that the HeartMate 3 (HM3) pump is associated with reduced strokes compared with the HeartMate II (HMII) device. We now perform a comprehensive analysis of stroke events to evaluate their longitudinal occurrence, clinical correlates, patterns, and impact on outcome across the 2-year duration of support. Methods: MOMENTUM 3 is a randomized controlled trial of the HM3 centrifugal-flow pump versus the HMII axial-flow pump in patients with advanced heart failure, regardless of the intended goal of support (bridge to transplantation or destination therapy). Baseline and postimplantation clinical correlates of stroke events were assessed with multivariable analyses. Longitudinal patterns, including device association, type of stroke (hemorrhagic versus ischemic), changing severity of impairment assessed with the modified Rankin Scale (disabling [modified Rankin Scale score >3] versus nondisabling [modified Rankin Scale score ≤3]) over time, and association with outcome, were determined. Results: In 361 patients with the intended implant (189 HM3 and 172 HMII), 65 strokes (40 ischemic strokes and 25 hemorrhagic strokes) occurred in 52 patients at a median of 131 (range, 1–733) days. No difference in stroke rate was noted between 0 and 180 days of follow-up between devices. However, stroke incidence in the long-term period (181–730 days after left ventricular assist device) was 3.3 times lower for the HM3 group (HM3: 0.04 versus HMII: 0.13 events per patient-year; odds ratio, 0.23; 95% CI, 0.08–0.63; P =0.01). Treatment with the HM3 pump was the only independent predictor of lower stroke events. We found no direct association of blood pressure or antithrombotic regimens with observed stroke rates. A stroke event significantly lowered 2-year postimplantation survival regardless of subtype or initial severity of neurological impairment compared with patients without a stroke (43±12% for hemorrhagic stroke, 57±9% for ischemic stroke, 51±11% for disabling, and 51±11% for nondisabling compared with 85±2% 2-year survival for patients without stroke). Conclusions: The HM3 pump is associated with a marked reduction in stroke rates compared with the HMII device, with benefits observed in the long-term period (>6 months). The occurrence of stroke of any type (hemorrhagic and ischemic) or of any functional severity (disabling and nondisabling) is predictive of a poor 2-year clinical outcome. Clinical Trial Registration: URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT02224755.

Left ventricular assist devices (LVAD) have been increasingly used in the treatment of end-stage heart failure. While warfarin has been uniformly recommended in the long-term as anticoagulation strategy, no clear recommendation exists for the post-operative period. We sought to evaluate the feasibility of enoxaparin in the immediate and early postoperative period after LVAD implantation.This is a two-center, retrospective analysis of 250 consecutive patients undergoing LVAD implantation between January 2017 and December 2018. Patients were bridged postoperatively to therapeutic INR by either receiving unfractionated heparin (UFH) or low molecular weight heparin (LMWH). Patients were followed while inpatient and for 3 months after LVAD implantation. The efficacy outcome was occurrence of first and subsequent cerebrovascular accident while safety outcome was the occurrence of bleeding events. Length of stay (LOS) was also assessed.Two hundred fifty and 246 patients were analyzed for index admission and 3-month follow up respectively. No statistically significant differences were found between the two groups in CVA (OR = 0.67; CI = 0.07-6.39, P = 0.73) or bleeding events (OR = 0.91; CI = 0.27-3.04, P = 0.88) during index admission. Similarly, there were no differences at 3 months in either CVAs or bleeding events (OR = 0.85; 0.31-2.34; p = 0.76). No fatal events occurred during the study follow-up period. Median LOS was significantly lower (4 days; p = 0.03) in the LMWH group.LMWH in the immediate and early postoperative period after LVAD implantation appears to be a concurrently safe and efficacious option allowing earlier postoperative discharge and avoidance of recurrent hospitalizations due to sub-therapeutic INR.

Objective To determine characteristics, outcomes, and clinical factors associated with death in patients with COVID-19 requiring extracorporeal membrane oxygenation (ECMO) support. Methods A multicenter, retrospective cohort study was conducted. The cohort consisted of adult patients (18 years of age and older) requiring ECMO in the period from March 1, 2020, to September 30, 2020. The primary outcome was in-hospital mortality after ECMO initiation assessed with a time to event analysis at 90 days. Multivariable Cox proportional regression was used to determine factors associated with in-hospital mortality. Results Overall, 292 patients from 17 centers comprised the study cohort. Patients were 49 (interquartile range, 39-57) years old and 81 (28%) were female. At the end of the follow-up period, 19 (6%) patients were still receiving ECMO, 25 (9%) were discontinued from ECMO but remained hospitalized, 135 (46%) were discharged or transferred alive, and 113 (39%) died during the hospitalization. The cumulative in-hospital mortality at 90 days was 42% (95% confidence interval [CI], 36%-47%). Factors associated with in-hospital mortality were age (adjusted hazard ratio [aHR], 1.31; 95% CI, 1.06-1.61 per 10 years), renal dysfunction measured according to serum creatinine level (aHR, 1.21; 95% CI, 1.01-1.45), and cardiopulmonary resuscitation before ECMO placement (aHR, 1.87; 95% CI, 1.01-3.46). Conclusions In patients with severe COVID-19 necessitating ECMO support, in-hospital mortality occurred in fewer than half of the cases. ECMO might serve as a viable modality for terminally ill patients with refractory COVID-19., Graphical abstract A multicenter, retrospective cohort study of 292 patients with COVID-19 given extracorporeal membrane oxygenation (ECMO) in 17 centers across the United States from March 1, 2020 to September 30, 2020. Clinical characteristics and outcomes were entered into a Research Electronic Data Capture (REDCap) database. The primary outcome of cumulative in-hospital mortality at 90 days was 42% (95% confidence interval [CI], 36%-47%).

Background Left ventricular assist devices (LVAD) have been increasingly used in the treatment of end-stage heart failure. While warfarin has been uniformly recommended in the long-term as anticoagulation strategy, no clear recommendation exists for the post-operative period. We sought to evaluate the feasibility of enoxaparin in the immediate and early postoperative period after LVAD implantation. Methods This is a two-center, retrospective analysis of 250 consecutive patients undergoing LVAD implantation between January 2017 and December 2018. Patients were bridged postoperatively to therapeutic INR by either receiving unfractionated heparin (UFH) or low molecular weight heparin (LMWH). Patients were followed while inpatient and for 3 months after LVAD implantation. The efficacy outcome was occurrence of first and subsequent cerebrovascular accident while safety outcome was the occurrence of bleeding events. Length of stay (LOS) was also assessed. Results Two hundred fifty and 246 patients were analyzed for index admission and 3-month follow up respectively. No statistically significant differences were found between the two groups in CVA (OR = 0.67; CI = 0.07–6.39, P = 0.73) or bleeding events (OR = 0.91; CI = 0.27–3.04, P = 0.88) during index admission. Similarly, there were no differences at 3 months in either CVAs or bleeding events (OR = 0.85; 0.31–2.34; p = 0.76). No fatal events occurred during the study follow-up period. Median LOS was significantly lower (4 days; p = 0.03) in the LMWH group. Conclusions LMWH in the immediate and early postoperative period after LVAD implantation appears to be a concurrently safe and efficacious option allowing earlier postoperative discharge and avoidance of recurrent hospitalizations due to sub-therapeutic INR.

Highly specialized left ventricular assist device care is not readily available in many areas, potentially limiting access to therapy. This retrospective analysis examines the relationship of outcomes by patient distance from implanting left ventricular assist device center within the Mechanical Circulatory Support Research Network. Zip codes were used to calculate patient distance, with the primary outcome of interest being 3-year survival by distance from the surgical center. Secondary outcomes included 90-day survival and incident event rates for the following: gastrointestinal bleeding, infection, cerebral event, and pump thrombosis. Across the four centers, there were 1184 patients supported for a median of 486 days. Overall survival was 91 ± 0.8% at 90 days and 61 ± 1.9% at 3 years, with worse 3-year survival in those living >90 vs. ≤90 miles from the ventricular assist device implant center (55 ± 3.0% vs. 64 ± 2.5, p = 0.019). Patients living >90 miles from an implant center were older, more likely to be implanted for destination therapy support, had a prior sternotomy, and had worse renal function than those living closer (p

Background: The MOMENTUM 3 trial compares the centrifugal HeartMate 3 (HM3) with the axial HeartMate II (HMII) continuous-flow left ventricular assist system in patients with advanced heart failure, irrespective of the intended goal of therapy. The trial’s 2-year clinical outcome (n=366) demonstrated superiority of the HM3 for the primary end point (survival free of a disabling stroke or reoperation to replace or remove a malfunctioning pump). This analysis evaluates health resource use and cost implications of the observed differences between the 2 devices while patients were enrolled in the trial. Methods: We analyzed all hospitalizations and their associated costs occurring after discharge from the implant hospitalization until censoring (study withdrawal, heart transplantation, and pump exchange with a nonstudy device or death). Each adjudicated episode of hospital-based care was used to calculate costs (device-attributable and non–device-attributable event costs), estimated by using trial data and payer administrative claims databases. Cost savings stratified by subgroups (study outcome [transplant, death, or ongoing on device], intended goal of therapy, type of insurance, or sex) were also assessed. Results: In 366 randomly assigned patients, 361 comprised the as-treated group (189 in the HM3 group and 172 in the HMII group), of whom 337 (177 in the HM3 group and 160 in the HMII group) were successfully discharged following implantation. The HM3 arm experienced fewer total hospitalizations per patient-year (HM3: 2.1±0.2 versus HMII: 2.7±0.2; P =0.015) and 8.3 fewer hospital days per patient-year on average (HM3: 17.1 days versus HMII: 25.5 days; P =0.003). These differences were driven by patients hospitalized for suspected pump thrombosis (HM3: 0.6% versus HMII: 12.5%; P P =0.002). Controlled for time spent in the study (average cumulative cost per patient-year), postdischarge HM3 arm costs were 51% lower than with the HMII (HM3: $37 685±4251 versus HMII: $76 599±11 889, P Conclusions: In this 2-year outcome economic analysis of the MOMENTUM 3 trial, the HM3 demonstrated a reduction in rehospitalizations, hospital days spent during rehospitalizations, and a significant cost savings following discharge in comparison with the HMII left ventricular assist system, irrespective of the intended goal of therapy. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02224755.

Background Primary outcomes analysis of the Multicenter Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3 (MOMENTUM 3) trial short-term cohort demonstrated a higher survival rate free of debilitating stroke and reoperation to replace/remove the device (primary end-point) in patients receiving the HeartMate 3 (HM3) compared with the HeartMate (HMII). In this study we sought to evaluate the individual and interactive effects of pre-specified patient subgroups (age, sex, race, therapeutic intent [bridge to transplant/bridge to candidacy/destination therapy] and severity of illness) on primary end-point outcomes in MOMENTUM 3 patients implanted with HM3 and HMII devices. Methods Cox proportional hazard models were used to analyze patients enrolled in the “as-treated cohort” ( n = 289) of the MOMENTUM 3 trial to: (1) determine interaction of various subgroups on primary end-point outcomes; and (2) identify independent variables associated with primary end-point success. Results Baseline characteristics were well balanced among HM3 ( n = 151) and HMII ( n = 138) cohorts. No significant interaction between the sub-groups on primary end-point outcomes was observed. Cox multivariable modeling identified age (≤65 years vs >65 years, hazard ratio 0.42 [95% confidence interval 0.22 to 0.78], p = 0.006]) and pump type (HM3 vs HMII, hazard ratio 0.53 [95% confidence interval 0.30 to 0.96], p = 0.034) to be independent predictors of primary outcomes success. After adjusting for age, no significant impact of sex, race, therapeutic intent and INTERMACS profiles on primary outcomes were observed. Conclusions This analysis of MOMENTUM 3 suggests that younger age (≤65 years) at implant and pump choice are associated with a greater likelihood of primary end-point success. These findings further suggest that characterization of therapeutic intent into discrete bridge-to-transplant and destination therapy categories offers no clear clinical advantage, and should ideally be abandoned.

Purpose Left ventricular assist device (LVAD) explant or decommission for LV recovery is rare (1-2%). Furthermore, details regarding appropriate patient selection, surgical technique and short- and long-term patient outcomes are limited (1,2). Four different surgical techniques have been described for cessation of LVAD support for LV recovery (3). The purpose of our study is to describe our experience for patients undergoing LVAD explantation or decommission. Methods We retrospectively reviewed the surgical technique and outcomes for our LVAD patients who were explanted and decommissioned between 2010 and 2020. Baseline demographics were examined. Specific surgical techniques utilized along with outcome analysis including infection, thromboembolic events, LVEF change, need for re-implantation and death were analyzed. Results Thirteen patients were identified who underwent either LVAD explant or decommission with a mean age of 43. All patients had underlying non-ischemic cardiomyopathy. Nearly half (53%) of the patients were selected due to a combination of LV recovery (mean LVEF 47% in this group) and an indication for device removal including pump thrombosis or infection (versus LV recovery alone). Surgical technique varied between full sternotomy with pump explant (69%) and thoracotomy with pump decommission (31%) depending on indication. Median follow up was 70 months. Results are displayed in table 1. In those with LV recovery alone, many experienced a drop in LVEF with clinical HF symptoms, but not resulting in re-implantation or mortality. All patients with infection and LV recovery experienced a drop in LVEF and recurrent HF, with a mortality rate of 50%. Conclusion LVAD explant or decomissioning can be performed via full sternotomy or thoracotomy depending on the indication. When performed for LV recovery and another reason, such as device infection, recurrent, severe HF can be fatal in this cohort. Careful monitoring of these patients is therefore required after such an operation.

Device indications have changed for placement of continuous-flow left ventricular assist devices (CF-LVADs). We performed a multicenter analysis evaluating temporal variations in outcomes after CF-LVAD implantation.We retrospectively defined 3 time intervals to reflect changes in CF-LVAD technology (period 1, 2004-2009; period 2, 2010-2012; and period 3, 2012-2014). A total of 1,064 patients (Heartmate II [HMII] = 835; Heartware [HVAD] = 229) underwent CF-LVAD implantation from May 2004 to October 2014. Device utilization was different between periods: period 1: HMII = 134 (100%); period 2: HMII = 480 (88%) and HW = 63 (12%); and period 3: HMII = 221 (57%) and HW = 166 (43%); P .001. Despite few baseline group differences, adjusted survivals were similar among the time periods (P = .96). Adjusted multivariable analysis revealed age (per 10-year increase) and Interagency Registry for Mechanically Assisted Circulatory Support category (1 vs all others) as the only independent predictors of mortality: P .001 and P = .008, respectively. Furthermore, it also showed the later periods to be at an increased risk of adverse events: 1) pump thrombosis (periods 2 and 3); and 2) gastrointestinal bleeding (period 3).Despite significant differences in device types, indications, and patient characteristics, post-implantation survivals were similar across time intervals. The most recent cohort seems to be at an increased risk of gastrointestinal bleeding and pump thrombosis.

Temporary circulatory support (TCS) is used to stabilize patients in critical cardiogenic shock and bridge patients to a durable ventricular assist device (VAD). Whether TCS confers increased risk at the time of VAD implant is unknown.Prospectively collected data from five institutions was retrospectively reviewed. All profile 1 through profile 3 patients implanted with a continuous-flow VAD (n = 804) were categorized into three groups: TCS (n = 68); non-TCS profile 1 (n = 70); and non-TCS profile 2-3 (n = 666).End-organ function and hemodynamics were worse before TCS than in non-TCS profile 1 patients: creatinine (1.7 ± 0.1 mg/dL versus 1.3 ± 0.06 mg/dL, p = 0.003); and right atrial pressure (16 ± 0.8 mm Hg versus 13 ± 1.1 mm Hg, p = 0.048). The TCS restored cardiac output before durable VAD (4.9 ± 0.2 L/min), and was comparable to profile 2-3 patients (4.3 ± 0.05 L/min) and better than profile 1 patients (4.0 ± 0.2 L/min, p = 0.002). Markers of hepatic function such as bilirubin were impaired before VAD in TCS and profile 1 patients (2.0 ± 0.2 mg/dL) compared with profile 2 and 3 patients (1.1 ± 0.03, p0.001). The incidence of postoperative right ventricular failure necessitating a right VAD was 21% for TCS patients and non-TCS profile 1 patients compared with 2% for profile 2-3 patients (p0.001). Profile 1 and TCS patients had similar 1-year survival (70% and 77%, p = 0.57), but inferior survival as compared with profile 2 and 3 patients (82%, p0.001). On multivariable analysis, TCS increased the hazard of death twofold.Temporary circulatory support restores hemodynamics and reverses end-organ dysfunction. Nevertheless, these patients have high residual risk with postoperative morbidity and mortality that parallels profile 1 patients without TCS. Caution is suggested in downgrading risk for TCS patients with improved hemodynamic stability.

Introduction Cardiac transplant centers are now successfully utilizing hepatitis C virus (HCV) donor hearts to increase the availability of organs now that a curative treatment is available with direct acting antivirals (DAA). We present the first described case of DAA treatment failure in a patient who received an HCV donor, nucleic acid testing (NAT) positive heart. Case Report A 65-year-old male with a mixed cardiomyopathy underwent orthotopic heart transplant with an HCV+/NAT+ heart. He seroconverted within seven days of transplant, noted by a peak HCV viral load of 7.65 log IU/mL and genotype of 1a without resistance markers. Planned initial treatment with glecaprevir/pibrentasvir (G/P) was denied by insurance. After approval for and treatment with ledipasvir/sofosbuvir (L/S) for 8 weeks, the patient's viral load was initially undetectable. However, he developed recurrent viremia 6 months after treatment completion with an HCV load of 7.40 log IU/mL with NS5A resistance due to a Y93H mutation. He was subsequently initiated on sofosbuvir/velpatasvir/voxilaprevir (S/V/V) with persistent undetectable viral loads to date at 4 months. Summary This is the first documented case of DAA treatment failure in a recipient of HCV+/NAT+ transplanted heart treated with L/S. This treatment failure was likely secondary to insufficient treatment duration. The ION-3 study demonstrated noninferiority for an 8 week treatment duration compared to 12 weeks of L/S, but at the cost of a higher relapse rate in the 8 week arm (5% vs 1%) associated with viral load of >6.78 log IU/mL. The Y93H mutation is more likely to reduce treatment efficacy in L/S as noted by a pooled resistance analysis compared to G/P, which has a failure rate of

The field of mechanical circulatory support has been impacted by the approval of new continuous-flow left ventricular assist devices (LVADs) and changes to the United States heart allocation system.Primary isolated continuous-flow LVAD implants in The Society of Thoracic Surgeons Intermacs registry from January 2014 through September 2019 were evaluated. Survival and freedom from major adverse events were compared between axial-flow, centrifugal-flow with hybrid levitation (CF-HL), and centrifugal-flow with full magnetic levitation (CF-FML) devices.Of 2603 devices implanted in 2014, 1824 (70.1%) were axial flow and 1213 (46.6%) were destination therapy (DT); through September 2019, 1752 devices were implanted, but only 37 (2.1%) were axial flow and 1230 (70.2%) were DT. Implants were performed in 13,016 patients between 2014 and 2018. Patients receiving implants in 2017-2018 compared with 2014-2016 were more likely to be at Intermacs profile 1 (17.1% vs 14.3%, P.001) and to have preimplant temporary mechanical circulatory support (34.8% vs 29.3%, P.001). Overall survival and freedom from major adverse events were higher with CF-FML devices. In multivariable analysis of survival between CF-HL and CF-FML, device type was not a significant early hazard, but the use of CF-HL devices had a late hazard ratio for death of 3.01 (P .001).Over the past 5 years, centrifugal-flow LVADs have become the dominant technology and DT the most common implant strategy. While outcomes with CF-FML devices are promising, comparisons with other devices from nonrandomized registry studies should be made with caution.

Introduction Patients with end-stage heart failure eligible for orthotopic heart transplantation (OHT) exceed the number of available donor organs. With highly effective hepatitis C virus (HCV) antiviral therapy now available, HCV+ organs are increasingly utilized. We seek to describe our experience with patients receiving HCV viremic organs as compared to non-HCV transplant recipients. Methods Our center began utilizing HCV hearts in February 2018. We retrospectively reviewed baseline demographics, laboratory data and outcomes for those undergoing OHT with majority being from a viremic HCV donor. Results Twenty-three of 25 HCV recipients received hearts from NAT+ donors with 22 of 23 seroconverting within 7 days. Fifteen recipients have completed HCV treatment, with the longest duration of follow-up being 13 months. No differences in rates of rejection, hospitalizations or death were seen between non-HCV and HCV transplant patients. Discussion With the advent of available direct-acting antivirals (DAAs), viremic HCV hearts provide an opportunity to increase organ availability. Moreover, treatment for HCV in the setting of immunosuppression is well-tolerated and results in sustained viremic response. Conclusion Viremic, discordant HCV OHT can be performed in a safe and effective manner utilizing a systematic, multidisciplinary approach without an effect on short-term outcomes.

Left ventricular assist device (LVAD) therapy remains a vital therapeutic option for patients with end-stage heart failure. Unfortunately, adverse events can occur and progress to require consideration for device exchange once the failure of medical management becomes evident, especially when heart transplantation is not possible in a timely manner. The aim of this analysis is to describe the incidence and outcomes of LVAD exchanges at our institution. Between April 2008 and May 2017, 397 patients underwent LVAD implantation, with 32 of those patients subsequently receiving exchange upon the recommendation of our multidisciplinary team due to refractory infection (n=12), device malfunction (n=5), hemolysis (n=9) and pump thrombosis (n=6). The average time from index implant to exchange was 580.6 days, with an average length of stay of 18.2 days. Survival at 3 months was 84.4%, 75.0% at 1 year and median at 8.3 years after exchange. The most common adverse events, occurring in less than 1/3 of the population, included bleeding, infection and stroke. This study suggests that LVAD exchange can be an effective and definitive mechanism for the treatment of otherwise potential fatal pump complications in highly select patients. Copyright: © 2019The Author(s). This is an open access article published under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License(https://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided that the original author(s) and the publication source are credited.

Purpose In October 2018, the United Network for Organ Sharing (UNOS) implemented extensive changes to the adult heart allocation policy. These changes were developed to better stratify medically urgent patients and provide more equitable geographic distribution of donor hearts. Instead of preferential distribution within a local donor service area, hearts are first considered by centers within 500 nautical miles of a donor hospital. We evaluated the impact of the new system on the mode and associated expense of procurement travel. Methods We retrospectively analyzed data from 5 centers across 5 states and 4 UNOS regions (regions 2, 5, 10, 11). Pre-allocation change (pre-change) was considered 10/1/2016-10/17/2018 and post-allocation change (post-change) was considered 10/18/18-8/31/2019. The share of procurements requiring a flight vs local transportation from all centers was compared. Cost of transportation for procurement and distance from donor hospital to transplant center was available from 4 centers. Results Total of 693 transplants were performed during the study period: 477 pre-change and 216 post-change. Pre-change, there were 274 flights for procurement compared to 182 flights post-change (57 vs 84%, p Conclusion Following the 2018 UNOS change to the heart allocation system, the proportion of flights and distance traveled for organ procurements significantly increased across 5 moderate-high volume centers, nearly doubling the average travel cost for procurement. These findings may guide transplant centers, payers, and policy makers regarding necessary procurement resources. Further study is needed to determine how these changes may affect lower volume centers with fewer resources.

Purpose Hepatitis C (HCV) organs have been increasingly utilized in solid organ transplantation since the advent of curative direct acting anti-viral (DAA) therapy. Despite the adoption of this strategy, many unanswered questions remain regarding the management of immunosuppression. In two small case series of liver transplant recipients, tacrolimus concentrations have been shown to decrease with clearance of HCV viremia. We seek to describe our experience and clinical implications in our cardiac transplant population. Methods We adopted the strategy of HCV cardiac transplantation followed by curative treatment in February of 2018. We analyzed the change in tacrolimus levels after DAA therapy in those who developed viremic HCV after receiving an HCV organ. Immunosuppression regimens were not altered for these patients from standard of care, which includes no induction therapy, corticosteroid taper by 6 months, and tacrolimus and mycophenolate mofetil as tolerated. Drug levels of tacrolimus were collected, as were clinical outcomes inclusive of infection, rejection and death. Results Twenty of twenty six NAT+/HCV+ patients experienced a decrease in tacrolimus levels with treatment, from a mean of 11.6 to a mean of 6.5 after HCV treatment. This decrease occurred towards the end of treatment and did not correspond with changes in tacrolimus dosing or other immunosuppressive agents. When compared to the non-HCV transplant population (n=37), no change in outcomes were observed. Conclusion Treatment of HCV after transplantation may be correlated with increased metabolism, resulting in more rapid clearance of tacrolimus. Careful monitoring of drug levels and graft function is recommended as HCV organs are increasingly utilized. Further investigation into the clinical implications of these metabolic changes is warranted.

Objectives Secondary mitral regurgitation (MR), not amenable to percutaneous or surgical repair, is common in advanced heart failure patients considered for LVAD implantation. Single center analyses have suggested variable frequency of persistent MR after LVAD implantation and consequent pulmonary hypertension, worse right heart function and more readmissions. The contemporary impact of newer devices such as the HeartMate 3 (HM3) on amelioration of MR post-LVAD implant remains uncertain. In this analysis of the MOMENTUM 3 pivotal trial and its Continued Access Protocol (CAP) study, we propose to assess the burden of significant residual MR and to evaluate the impact on clinical outcomes. Methods Patients implanted with the HeartMate II (HMII) or HM3 pump in the MOMENTUM 3 pivotal trial were evaluated over 24 months to assess their relative impact on residual MR. An extended analysis of the first 500 implanted patients in CAP (HM3 only) will also be performed to validate observations from within the pivotal trial. Data on the presence and severity of MR using echocardiography were collected at baseline (pre-implant) and throughout the 24-month follow-up. Endpoints In the pivotal trial (n=1020), 44% of patients had significant (moderate to severe) MR at baseline and 8.8% (90/1020) had undergone a prior or concomitant mitral valve procedure. In patients with no surgical mitral valve correction, overall rates of significant residual MR (irrespective of baseline MR) at each follow-up visit are shown in Figure 1. Of those patients with significant MR at baseline, 28% had persistent significant residual MR during study follow-up. In this group, HM3 patients experienced a lower frequency of significant residual MR (24%) than HMII patients (33%, p=0.05). Survival, right heart failure, and freedom from all-cause readmissions were not significantly different between patients with and without significant residual MR. Endpoints will also be validated in the CAP cohort and in patients with concomitant mitral valve correction. (Funded by Abbott).

Purpose In the era of increased left ventricular support device (LVAD) implantation, limited data is available on outcomes in the obese population, with most available data describing elevated BMI with a cutoff of >30 kg/m2. Forest et al examined the ISHLT Mechanically Assisted Circulatory Support (IMACS) registry and found no impact in 2-year mortality in those with higher BMIs, but an increase in all adverse events describing BMI > 40 kg/m2 group. We seek to provide our experience with this population. Methods We retrospectively reviewed outcomes in over 580 LVAD implantations performed at St. Vincent, Indianapolis IN between 2008-19. Baseline demographics of BMI subgroups (BMI 40 kg/m2) and outcomes were collected. Endpoints including survival, stroke, infection, gastrointestinal (GI) bleeding and right heart failure (RHF) were analyzed by BMI strata, with a specific focus on BMI > 40 kg/m2. RHF was defined with Interagency for Mechanically Assisted Circulatory Support (INTERMACS) definitions. Results Over 8% of LVAD patients had a BMI > 40 kg/m2 in our population. No differences were found in survival, stroke, infection, GI bleeding or hemolysis. Figure 1 displays time to right heart failure in BMI subgroups (1= BMI 40 kg/m2). As seen in figure 1, those with a BMI of > 40 kg/m2 were at significantly increased risk of RHF. Conclusion An increased incidence of RHF after LVAD without a concurrent increase in mortality is seen in our patients with a BMI > 40 kg/m2. Strategies for peri-operative and long-term management should take this finding into consideration. Further investigation on a larger, multi-center scale is warranted.

In an early analysis of this trial, use of a magnetically levitated centrifugal continuous-flow circulatory pump was found to improve clinical outcomes, as compared with a mechanical-bearing axial continuous-flow pump, at 6 months in patients with advanced heart failure.In a randomized noninferiority and superiority trial, we compared the centrifugal-flow pump with the axial-flow pump in patients with advanced heart failure, irrespective of the intended goal of support (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke (with disabling stroke indicated by a modified Rankin score of3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove a malfunctioning device. The noninferiority margin for the risk difference (centrifugal-flow pump group minus axial-flow pump group) was -10 percentage points.Of 366 patients, 190 were assigned to the centrifugal-flow pump group and 176 to the axial-flow pump group. In the intention-to-treat population, the primary end point occurred in 151 patients (79.5%) in the centrifugal-flow pump group, as compared with 106 (60.2%) in the axial-flow pump group (absolute difference, 19.2 percentage points; 95% lower confidence boundary, 9.8 percentage points [P0.001 for noninferiority]; hazard ratio, 0.46; 95% confidence interval [CI], 0.31 to 0.69 [P0.001 for superiority]). Reoperation for pump malfunction was less frequent in the centrifugal-flow pump group than in the axial-flow pump group (3 patients [1.6%] vs. 30 patients [17.0%]; hazard ratio, 0.08; 95% CI, 0.03 to 0.27; P0.001). The rates of death and disabling stroke were similar in the two groups, but the overall rate of stroke was lower in the centrifugal-flow pump group than in the axial-flow pump group (10.1% vs. 19.2%; hazard ratio, 0.47; 95% CI, 0.27 to 0.84, P=0.02).In patients with advanced heart failure, a fully magnetically levitated centrifugal-flow pump was superior to a mechanical-bearing axial-flow pump with regard to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755 .).

The Dor procedure was historically used to restore the geometry of the heart in a patient with a left ventricular (LV) aneurysm via reduction and reshaping of the LV with an aneurysmectomy. Unfortunately, morbidity and mortality remain high with this procedure, with many patients little to no recovery of their ejection fraction while developing severe diastolic failure, often requiring further support; however, the natural history of these patients remains largely unknown. Heart transplant has long been considered the most durable of treatment for patients with end-stage heart failure (HF), but because of the scarcity of donor hearts, the implantation of left ventricular assist devices (LVAD) for mechanical circulatory support has also proven to be an essential tool in the treatment of the advanced heart failure patient. While various techniques for LVAD implantation have been well outlined, there is very limited literature on placement of a VAD in patients with a history of LV aneurysmectomy or Dor procedures, particularly with regard to the challenging aspects of apical cannulation in those with prior apical ventriculotomy and patch placement. In this series, we describe three patients with a history of LV aneurysmectomy procedures who underwent Heartware ventricular assist device (HVAD) implantations for end-stage HF.

Purpose The psychosocial evaluation is of paramount importance when evaluating a patient's ability to be successful with left ventricular assist device (LVAD) therapy. Current guidelines recommend a “detailed psychosocial evaluation” but do not give any recommendations regarding the use of a specific clinical tool. The Stanford Integrated Psychosocial Assessment for Transplant (SIPAT) has been shown to predict both the psychosocial and medical outcomes in patients post-transplant; however, studies examining its utility in LVAD patients are limited. Methods We performed a single center, retrospective analysis, of 82 consecutive patients who underwent LVAD implantation from May 2017 to September 2018. Patients were classified into two groups based on a validated SIPAT cutoff score of Results Of the 82 patients, 46 (56%) had a score Conclusion Unlike cardiac transplant, the SIPAT score was not predictive of medical outcomes in patients undergoing LVAD therapy. A patient's underlying biologic effects may influence outcomes more than their psychosocial aspects. Prospective studies should be considered to further explore the validity of the SIPAT score in patients undergoing LVAD implantation.

Objectives The purpose of this study was to determine the risk factors for ischemic in hemorrhage cerebrovascular events in patients supported by the HeartWare ventricular assist device (HVAD). Background Patients supported with left ventricular assist devices are at risk for both ischemic and hemorrhagic cerebrovascular events. Methods Patients undergoing implantation with a HVAD as part of the bridge-to-transplant trial and subsequent continued access protocol were included. Neurological events (ischemic cerebrovascular accidents [ICVAs] and hemorrhagic cerebrovascular accidents [HCVAs]) were assessed, and the risk factors for these events were evaluated in a multivariable model. Results A total of 382 patients were included: 140 bridge-to-transplant patients from the ADVANCE (Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure) clinical trial and 242 patients from the continued access protocol. Patients had a mean age of 53.2 years; 71.2% were male, and 68.1% were white. Thirty-eight percent had ischemic heart disease, and the mean duration of support was 422.7 days. The overall prevalence of ICVA was 6.8% (26 of 382); for HCVA, it was 8.4% (32 of 382). Pump design modifications and a protocol-driven change in the antiplatelet therapy reduced the prevalence of ICVA from 6.3% (17 of 272) to 2.7% (3 of 110; p = 0.21) but had a negligible effect on the prevalence of HVCA (8.8% [24 of 272] vs. 6.4% [7 of 110]; p = 0.69). Multivariable predictors of ICVA were aspirin ≤81 mg and atrial fibrillation; predictors of HCVA were mean arterial pressure >90 mm Hg, aspirin ≤81 mg, and an international normalized ratio >3.0. Eight of the 30 participating sites had established improved blood pressure management (IBPM) protocols. Although the prevalence of ICVA for those with and without IBPM protocols was similar (5.3% [6 of 114] vs. 5.2% [14 of 268]; p = 0.99), those with IBPM protocols had a significantly lower prevalence of HCVA (1.8% [2 of 114] vs. 10.8% [29 of 268]; p = 0.0078). Conclusions Anticoagulation, antiplatelet therapy, and blood pressure management affected the prevalence of cerebrovascular events after implantation of the HVAD. Attention to these clinical parameters can have a substantial impact on the occurrence of serious neurological events. (Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure [ADVANCE]; NCT00751972)

Background Recent reports suggested that HeartMate II (HMII) thrombosis rates may be higher in implants after 2011. We characterize events at HMII centers (>100 HMII implants) whose device thrombosis rates are equivalent or lower than reported by INTERMACS. Methods Seven centers pooled implants from 2011 through June 2013 to examine pump thrombus and identify characteristics and clinical strategies that potentially mitigate the risk. A total of 666 patients (age 59 ± 13 years; 81% male) were studied (support duration: 13.7 ± 8.3 months, cumulative: 759 patient years). Median target INR was 2.25 (range 2.0 to 2.5), and median pump speed was 9200 rpm (range 8600 to 9600). Pump thrombus was suspected with clinical evidence (e.g., hemolysis, positive ramp test) requiring intervention (e.g., anticoagulation therapy, pump exchange) or patient death. Results Suspected pump thrombus occurred in 24/666 (3.6%) patients within three months of implant. At six months, 38/666 (5.7%) had suspected pump thrombus including 24 (3.6%) resulting in pump exchange or death. Stroke (hemorrhagic: 0.049, and ischemic: 0.048 events/patient year) and survival (six months: 88 ± 1%; 1 year: 81 ± 2%) were consistent with national averages. Suspected pump thrombus patients were younger (55 ± 13 vs. 59 ± 13, p = 0.046) and had more females (31.6% vs. 18.3%, p = 0.054). There was no difference in indication, etiology of heart failure, or body size. Conclusions This analysis demonstrates low HMII thrombus events. Minimization of risk factors by uniform implant techniques and consistent post-op management may reduce device thrombosis. A larger scale multicenter evaluation may better elucidate the difference in thrombus events between centers. doi: 10.1111/jocs.12607 (J Card Surg 2015;30:775–780)

The aims of this analysis were to characterize the burden and timing of bleeding events in females versus males on left ventricular assist device (LVAD) support. A single-center retrospective review of 375 patients receiving continuous-flow LVADs was performed. Bleeding events included gastrointestinal, naso-oropharyngeal, gynecologic (GYN), intracranial hemorrhage (ICH), and mediastinal bleeding. Cox hazard ratios (HRs) [95% CI] and incident event rates for females versus males were calculated. Eighty-four females (22%) and 291 males (78%) received an LVAD. There were 189 patients with 406 bleeding events over a median 399 days of support. Two-year freedom from bleeding was 33 ± 6.2% in females and 46 ± 3.7% in males (p = 0.027). Correlates of bleeding included female sex (adjusted HR = 1.6 [1.1-2.2]) and older age (adjusted HR = 1.2 [1.1-1.3] per 10 years). There was no sex-associated difference in 30 day mediastinal bleeding (males 12%; females 16% at 30 days; overall p = 0.35), but incident event rates for overall bleeding and naso-oropharyngeal bleeding were higher in females (p < 0.05) and trends were noted in ICH (eppy: 0.06 male vs. 0.10 female, p = 0.14). Eight females (10%) experienced 12 GYN bleeding events; five required surgical intervention. In summary, females had a 60% higher hazard of bleeding than males with significant morbidity encountered from mucosa (including vaginal) bleeding. Future large device studies should be inclusive of sex-specific outcomes.

Recently, a percutaneous right ventricular assist device (RVAD) called the TandemLife Protek Duo (TPD; TandemLife, Pittsburgh, PA) has been introduced. The Protek Duo (TPD) is a temporary RVAD placed via the right internal jugular vein, capable of providing up to 4.5 L of flow. We report a two-center experience using the TPD in 17 patients with right ventricular (RV) failure, 12 of whom were post-left ventricular assist device (LVAD) implantation.

Background: The HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) (Abbott) is a centrifugal, fully magnetically levitated, continuous-flow blood pump engineered to enhance hemocompatibility and reduce shear stress on blood components. The MOMENTUM 3 trial (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) compares the HM3 LVAS with the HeartMate II (HMII) LVAS (Abbott) in advanced heart failure refractory to medical management, irrespective of therapeutic intention (bridge to transplant versus destination therapy). This investigation reported its primary outcome in the short-term cohort (n=294; 6-month follow-up), demonstrating superiority of the HM3 for the trial primary end point (survival free of a disabling stroke or reoperation to replace the pump for malfunction), driven by a reduced need for reoperations. The aim of this analysis was to evaluate the aggregate of hemocompatibility-related clinical adverse events (HRAEs) between the 2 LVAS. Methods: We conducted a secondary end point evaluation of HRAE (survival free of any nonsurgical bleeding, thromboembolic event, pump thrombosis, or neurological event) in the short-term cohort (as-treated cohort n=289) at 6 months. The net burden of HRAE was also assessed by using a previously described hemocompatibility score, which uses 4 escalating tiers of hierarchal severity to derive a total score for events encountered during the entire follow-up experience for each patient. Results: In 289 patients in the as-treated group (151 the HM3 and 138 the HMII), survival free of any HRAE was achieved in 69% of the HM3 group and in 55% of the HMII group (hazard ratio, 0.62; confidence interval, 0.42–0.91; P =0.012). Using the hemocompatibility score, the HM3 group demonstrated less pump thrombosis requiring reoperation (0 versus 36 points, P P =0.02), and fewer nondisabling strokes (6 versus 24 points, P =0.026) than the control HMII LVAS. The net hemocompatibility score in the HM3 in comparison with the HMII patients was 101 (0.67±1.50 points/patient) versus 137 (0.99±1.79 points/patient) (odds ratio, 0.64; confidence interval, 0.39–1.03; P =0.065). Conclusions: In this secondary analysis of the MOMENTUM 3 trial, the HM3 LVAS demonstrated greater freedom from HRAEs in comparison with the HMII LVAS at 6 months. Clinical Trial Registration: URL: http://clinicaltrials.gov . Unique identifier: NCT02224755.

The aim of this study was to evaluate the prevalence of early pump power elevation events in patients with the HeartMate II (HMII) and its impact on subsequent development of stroke and pump thrombosis.We analyzed45,000 measurements of pump power and pump speed measured during the initial hospitalization period and12,000 follow-up measurements obtained from 138 consecutive patients implanted with a HMII between January 2009 and December 2012. An early power elevation (PEL) event was defined as power ≥10 W within the first 14 post-operative days. Patients were divided into two groups: those with an early PEL event and those without (NP).Median follow-up duration was 316 (range 2 to 1,264) days. Twenty-seven (20%) patients had early PEL events that lasted for a total duration of 4 (range 1 to 77) hours per patient. Pump speed averaged 9,400 rpm in both groups. Although patients in the PEL group had higher median power (7.1 [6.0 to 9.9] W vs 6.7 [5.7 to 7.8] W, p0.001) in the immediate post-operative period, there was no difference between the two groups noted at first follow-up (6.6 [5.9 to 8.7] W vs 6.7 [5.5 to 7.7] W, p = 0.940). No differences in the prevalence of hemorrhagic stroke (4% vs 3%, p = 0.56), ischemic stroke (0% vs 4%, p = 0.41), hemolysis (7% vs 5%, p = 0.32), pump thrombosis (7% vs 4%, p = 0.21) or survival (76% at 1 year in both groups) were found between the two groups.In this single-center experience, PEL events that occurred early all resolved by discharge. No relationship was found between early PEL events and subsequent development of pump thrombosis, hemorrhagic stroke or ischemic stroke.

Background Preexisting valve pathology is common in patients with end-stage heart failure undergoing left ventricular assist device (LVAD) placement. The indications and subsequent benefits of performing valvular procedures in these patients are unclear. The objective of this study was to determine the impact of performing concurrent surgical valve procedures in a large cohort of patients receiving LVADs. Methods One thousand one hundred six patients received the HeartMate II (HMII) LVAD in the bridge to transplant (n = 470) and destination therapy (n = 636) clinical trials. Of these, 374 patients (34%) had concurrent cardiac surgery procedures as follows: 242 patients (21%) with 281 concurrent valve procedures (VP) (aortic 80, mitral 45, and tricuspid 156), and 641 patients had only HMII LVAD. The focus of this study was to determine the clinical outcomes of patients undergoing HMII + VP compared with those who received HMII alone. Results Patients undergoing HMII + VP were significantly older, had higher blood urea nitrogen levels and central venous pressure, and decreased right ventricular stroke work index; intraoperatively, the median cardiopulmonary bypass times were also longer. The unadjusted 30-day mortality was significantly higher in patients undergoing HMII + VP (10.3% vs 4.8% for LVAD alone, P = .005). Subgroup analysis of individual VPs showed that higher mortality occurred in patients with HMII plus 2 or more VPs (13.5%, P = .04) followed by trends for increased mortality with HMII plus mitral alone (11.5%, P = NS), HMII plus aortic alone (10.9%, P = NS), and HMII plus tricuspid (8.9%, P = NS) procedures. Of these various groups, only patients undergoing HMII + isolated aortic VP ( P = .001) and HMII + multiple VPs ( P = .046) had significantly worse long-term survival compared with patients undergoing HMII alone. Right heart failure and right ventricular assist device use was increased in patients undergoing VPs, but there was no difference in the incidence of bleeding or stroke. Conclusions Patients frequently require concurrent VPs at the time of LVAD placement; these patients are sicker and have higher early mortality. Furthermore, right ventricular dysfunction is increased in these patients. Further studies to develop selection criteria for concurrent valve interventions are important to further improve clinical outcomes.

Purpose The HeartMate 3 (HM3) Left Ventricular Assist System is a fully magnetically levitated, centrifugal, continuous-flow pump. In the MOMENTUM 3 trial, the HM3 apical cuff could be attached with two different Methods Cut then Sew or Sew then Cut. This analysis describes the surgical techniques used in the trial and evaluates their impact on outcomes. Methods 189 patients in the Long Term (LT) cohort were implanted with the HM3 pump. Patients were divided into groups based on the technique used to attach the apical cuff at implant. Survival and adverse events at 2 years of follow-up were compared between the groups. The burden of hemocompatibility related adverse events (HRAE) was evaluated with a previously defined hemocompatibility score (Mehra. Eur Heart J. 2017). Continuous and categorical data were compared with the Wilcoxon rank sum and chi-square tests. The log-rank test was used to compare survival. This analysis will be updated to the 515 patients implanted with HM3 in the Full Cohort, which will be available in March 2019. Results 189 patients were implanted with HM3 by 68 surgeons at 52 centers. The median implant and bypass times were 261 and 83 minutes respectively. The majority of implants used the Cut then Sew apical attachment method (64%), true apical inflow cannula insertion (79%), silicone to skin driveline interface (90%), and right-sided driveline exit (54%). Cut then Sew was associated with longer median bypass times when compared to Sew then Cut (86 vs 77.5 minutes, p = 0.033). In the LT Cohort, there were no significant differences in 2-year survival between the groups (log-rank P=0.16). However, there was a trend for Cut then Sew to have a higher risk of stroke compared to Sew then Cut (Figure). Patients implanted with Cut then Sew vs Sew then Cut were also more likely to have a hemocompatibility score>1 (27% vs 15%, p=0.048). Conclusion We demonstrate that the Cut then Sew method used additional bypass time and may confer a higher stroke risk and HRAE net burden compared to Sew then Cut pump implantation technique.

Purpose Patients with end-stage heart failure eligible for orthotopic heart transplantation (OHT) exceeds the number of available donor organs. With the introduction of curative medications for hepatitis C (HCV), these hearts are now being utilized in an effort to expand organ availability. The safety and feasibility of these organs in OHT has been previously described; however, many of the donor hearts were HCV immune and non-viremic. We seek to describe our experience with patients receiving HCV viremic organs. Methods St. Vincent Hospital in Indianapolis, IN began utilizing HCV hearts for OHT in February 2018. We retrospectively reviewed baseline demographics, laboratory data and outcomes for those undergoing OHT from a viremic donor. Results Basic information and results are reported in Tables 1 and 2. To date, 5 recipients have completed HCV treatment, with the longest duration of follow up currently 8 months. The average seroconversion time of a viremic heart was 7 days. Compared to non-HCV donors during this same timeframe, there was no increase in infection, rejection or number of hospitalizations. Additionally, patients completing antiviral treatment have had a sustained virologic response, with another 2 currently undergoing treatment and the final 3 awaiting insurance approval to initiate treatment. Conclusion In our early experience, we have demonstrated the feasibility of utilizing viremic HCV donor hearts for organ transplantation , thereby increasing the pool of available donors for patients that may not have otherwise received an organ. Further analysis of discordant HCV transplantation's financial impact is currently ongoing.

Influenza remains a frequent cause of hospitalization and death during the winter season. Since early in March of 2018, influenza B has been more frequently reported than influenza A. While the incidence of myocarditis from influenza is rare (from 0-11%), the severity of illness can include

Pump thrombosis is a dreaded complication of long-term implantable ventricular assist devices. No guidance exists regarding the diagnosis and management of this entity despite its significant morbidity. After considerable thought and deliberation, a group of leading investigators in the field of mechanical support propose an algorithm for the diagnosis and management of this vexing entity based on clinical symptoms and serologic and imaging studies.

The aim of this study was to evaluate the performance of an adjusted HeartMate II risk score (HMRS) in Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS; n = 9,733) and in HeartWare Ventricular Assist Device (HVAD) bridge to transplant (BTT) trial patients (n = 360). Interagency Registry for Mechanically Assisted Circulatory Support data were used to calculate an adjusted HMRS, omitting center volume, for all patients on continuous-flow left ventricular assist device (LVAD) support. Ninety day mortality was then evaluated in INTERMACS and HVAD-BTT patients. Four risk groups were identified based on INTERMACS patient-adjusted HMRS: very low (5%, 90 day mortality; score0.20), low (5-10%, 90 day mortality; score 0.20-1.97), medium (10-20%, 90 day mortality; score 1.98-4.48), and high risk (20%, 90 day mortality; score4.48). Within INTERMACS, there were significant differences in survival between all-adjusted HMRS risk groups (p0.001 in pairwise comparisons). Controlling for known mortality correlates, the adjusted HMRS mortality hazard ratio was 1.19 (1.25-1.23) per unit HMRS increase. The HVAD cohort was a low-risk cohort with 90 day survivals for very low-, low-, and medium-risk patients of 100%, 97 ± 1.1%, and 90 ± 3.6%, respectively (p = 0.007). Patients in the very low- and low-risk group had significantly improved survival compared with medium-risk patients, respectively (both p0.05). The adjusted HMRS appropriately risk stratified a large cohort of INTERMACS patients and was predictive of survival in HeartWare-supported patients.

Background: Severe vascular disease is a relative contraindication to heart transplantation (HTx). We addressed the effect of vascular disease on HTx outcomes.Methods:This is a nonconcurrent cohort study of 402 patients who received HTx at our institution between 1985 and 2004. Pretransplant vascular evaluation included carotid, lower extremity, and renal artery duplex studies, and CTangiogram when indicated. Patients with severe and nontreatable vascular disease were excluded. Patients were divided into Group 1: those with pre-transplant vasculopathy, and Group 2: those without pre-transplant vasculopathy. Group 1 had 24 patients with 25 vascular lesions: 1 aortic dissection, 2 abdominal aortic aneurysm (AAA)’s, 5 carotid artery stenoses, 1 renal artery stenosis, and 16 peripheral vascular lesions. Interventions were performed to 15 lesions prior to HTx and to 2 lesions after HTx.Results:Median follow-up was 5.5 years. Group 1 had higher incidence of ischemic cardiomyopathy (p < 0.001), hypertension (p = 0.028), chronic obstructive pulmonary disease (COPD) (p = 0.004), and smoking history (p < 0.001). There were no differences in sex, hyperlipidemia, diabetes, stroke, or renal dysfunction. Multivariate analysis revealed odds of post-transplant death in Group 1 was 1.4 (95% CI: 0.48—4.1, p = 0.54) times greater than that in Group 2. Cox proportional hazards model for survival showed a 50% increase in the hazard of death in patients with pre-transplant vasculopathy, but without statistical significance. Group 1 had higher incidence of post-transplant stroke (p = 0.001) but no difference in allograft coronary atherosclerosis. Conclusions: Pre-transplant vascular disease seems to have negative effect on outcomes after HTx. Larger scale study is needed for further evaluation. # 2007 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) patient profiles and modifiers are descriptors of patient illness severity before durable ventricular assist device implantation. It is unknown how individual U.S. institutions and practitioners assign profiles and if modifiers improve on risk discrimination.Respondents (n = 212) to a web-based survey answered questions about the INTERMACS profile assignment process in their institution. For 5 hypothetical clinical scenarios, respondents assigned the best profile. The INTERMACS registry (2009-2014) was queried, and hazard ratio (HR) (95% confidence interval [CI]) for mortality between profiles as well as based on the presence of temporary circulatory support (TCS), frequent flyer (FF), or arrhythmia modifiers was calculated.Respondents included 131 (62%) cardiologists, 30 (14%) surgeons, and 51 (24%) physician extenders/coordinators. Institutional INTERMACS profile assignment was variable (63% assigned by cardiologists/surgeons; 10% by research coordinators; 27% by physician extenders). Profile assignments in hypothetical patient scenarios were heterogeneous, especially for contiguous profiles. The 1-year survivals for Profiles 1, 2, and 3 were 77 ± 1.2%, 80 ± 0.7%, and 84 ± 0.7% (p0.001). Although Profile 1 patients had worse adjusted survival than Profile 3 patients (p = 0.001), survival for Profile 1 patients vs Profile 2 patients was similar (adjusted HR = 1.01 [95% CI = 0.88-1.12]). The TCS (adjusted HR = 1.1 [95% CI = 0.94-1.2]) and arrhythmia (adjusted HR = 1.1 [95% CI = 0.97-1.2]) modifiers were not predictive of mortality, but the FF modifier was (HR = 1.3 [95% CI = 1.02-1.63]).Substantial heterogeneity exists in the process and assignment of INTERMACS profiles. This heterogeneity could affect mortality estimates used for risk stratification. Only the FF modifier appears to improve risk discrimination beyond that of known risk factors. Adding objective descriptors may reduce profile heterogeneity.

Background The management of traumatic aortic rupture has evolved from emergency surgery for all to incorporating nonoperative and endovascular approaches. In addition, the greater emphasis on restraint systems over the past decade might result in lower immediate mortality. Methods We reviewed our contemporary experience with reference to a previous report from the same institution to determine whether there has been improvement in outcome related to these factors. Results In 1990, a review of 104 patients admitted to our center over a 15-year period (1975-1990) noted an overall mortality of 65%. Forty-two patients died before they could reach the operating room, including 15 who were declared dead on arrival and 27 who died before reaching the operating room. All patients underwent angiography, followed by immediate operation. The mortality rate of those who reached the operating room was 34%, and paralysis-paraplegia occurred in 26% of survivors. A review of 53 patients admitted between January 1, 2000, and April 2005 documented an overall mortality of 26% and a paralysis rate of 4.5% in operative survivors. Only 3 patients died during initial evaluation, 2 who were in arrest on arrival. Eight patients were managed nonoperatively, and 13 were managed by means of deliberate delay before intervention to improve physiologic status. Finally, 19 patients were managed with endografts. Conclusion The improved outcome over the decade since the initial experience reflects both a reduced severity of injury attributable to restraint systems and a more flexible approach to the acute management, which can modify the effect of associated injuries.

Background Heart transplantation is an accepted treatment modality for end-stage heart failure. However, acute cellular rejection (ACR) continues to be a morbid complication. Recently a novel mechanism of inflammatory allograft injury has been characterized which involves overactivation of the nuclear enzyme poly (ADP-ribose) polymerase (PARP). In the present studies, we compared the efficacy of INO-1001, a novel, potent PARP inhibitor, in limiting ACR with and without adjuvant low-dose cyclosporine (CSA). Methods Heterotopic heart transplantation was performed utilizing Brown-Norway strains as donors and Lewis rats as recipients. Groups received daily intraperitoneal injections of: vehicle, low-dose CSA, low-dose INO-1001, high-dose INO-1001, and low-dose CSA combined with high-dose INO-1001. Additional animals were sacrificed on postoperative Day 5 for histologic assessments of allograft inflammation, including immunohistochemistry for nitrotyrosine and poly (ADP-ribose) (the product of PARP) staining. Results PARP inhibition significantly prolonged allograft survival relative to vehicle controls. The combination of low-dose CSA and INO-1001 resulted in a marked increase in allograft survival and significant reductions in allograft rejection scores. This was associated with decreased nitrotyrosine and PAR staining in transplanted cardiac allografts. Conclusions Pharmacologic inhibition of INO-1001 prolongs allograft survival in a dose-dependent fashion in a rodent model of heart transplantation. PARP inhibitors may permit reductions in the dose of CSA needed for adequate immunosuppression after heart transplantation.