Purpose: In 2018, UNOS amended the heart allocation policy to prioritize patients bridged with temporary mechanical circulatory support (tMCS) which led to greater use of IABP, ECMO, and percutaneous LVAD as a strategy to bridge to heart transplantation (HT). Subsequent studies of the Scientific Registry of Transplant Recipients (SRTR) demonstrated a reduced waitlist mortality with no effect on post-HT survival following the policy change. However, the impact of the policy change on morbidity is unknown.

Pulmonary vascular impedance (PVZ) describes RV afterload in the frequency domain and has not been studied extensively in LVAD patients. We sought to determine (1) feasibility of calculating a composite (c)PVZ using standard of care (SoC), asynchronous, pulmonary artery pressure (PAP) and flow (PAQ) waveforms; and (2) if chronic right ventricular failure (RVF) post-LVAD implant was associated with changes in perioperative cPVZ. PAP and PAQ were obtained via SoC procedures at three landmarks: T(1), Retrospectively, pre-operative with patient conscious; and T(2) and T(3), prospectively with patient anesthetized, and either pre-sternotomy or chest open with LVAD, respectively. Additional PAP’s were taken at T(4), following chest closure; and T(5), 4–24 h post chest closure. Harmonics (z) were calculated by Fast Fourier Transform (FFT) with cPVZ(z) = FFT(PAP)/FFT(PAQ). Total pulmonary resistance Z(0); characteristic impedance Zc, mean of cPVZ(2–4); and vascular stiffness PVS, sum of cPVZ(1,2), were compared at T(1,2,3) between +/-RVF groups. Out of 51 patients, nine experienced RVF. Standard hemodynamics and changes in cPVZ-derived parameters were not significant between groups at any T. In conclusion, cPVZ calculated from SoC measures is possible. Although data that could be obtained were limited it suggests no difference in RV afterload for RVF patients post-implant. If confirmed in larger studies, focus should be placed on cardiac function in these subjects.

BACKGROUND In the MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) pivotal trial, the HeartMate 3 (HM3) fully magnetically levitated left ventricular assist device (LVAD) demonstrated superiority over the axial -flow HeartMate II (HMII) LVAD. The patterns and predictors of hospitalizations with the HM3 LVAD have not been characterized. OBJECTIVES This study sought to determine causes, predictors, and impact of hospitalizations during LVAD support. METHODS Patients discharged after LVAD implantation were analyzed. In the pivotal trial, 485 recipients of HM3 were compared with 471 recipients of HMII. The pivotal trial HM3 group was also compared to 949 recipients of HM3 in the postapproval phase within the trial portfolio. Predictors of cause-specific rehospitalization were analyzed. RESULTS The rates of rehospitalization were lower with HM3 LVAD than with HMII LVAD in the pivotal trial (225.7 vs 246.4 events per 100 patient-years; P < 0.05). Overall, rehospitalization rates and duration were similar in the HM3 postapproval phase and pivotal trial but prolonged hospitalizations (> 7 days) were less frequent (rate ratio: 0.90 [95% CI: 0.80-0.98]; P < 0.05). In HM3 recipients, the most frequent causes of rehospitalization included infection, heart failure (HF)-related events, and bleeding. First rehospitalization caused by HF-related event versus other causes was associated with reduced survival (HR: 2.2 [95% CI: 1.3-3.9]; P 1/4 0.0014). Male sex, non-White race, presence of cardiac resynchronization therapy/implantable cardioverter-defibrillator, obesity, higher right atrial pressure, smaller LV size, longer duration of index hospitalization, and lower estimated glomerular filtration rate at index discharge predicted HF hospitalizations. CONCLUSIONS Contemporary support with the HM3 fully magnetically levitated LVAD is associated with a lower hospitalization burden than with prior pumps; however, rehospitalizations for infection, HF, and bleeding remain important challenges for progress in the patient journey. (C) 2022 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.

Background: Elevated right ventricular afterload following continuous-flow left ventricular assist device (CF-LVAD) may contribute to late right heart failure (LRHF). PDE5i (phosphodiesterase-5 inhibitors) are used to treat pulmonary hypertension and right heart dysfunction after CF-LVAD, but their impact on outcomes is uncertain. Methods: We queried Interagency Registry for Mechanically Assisted Circulatory Support from 2012 to 2017 for adults receiving a primary CF-LVAD and surviving ≥30 days from index discharge. Patients receiving early PDE5i (ePDE5i) at 1 month were propensity-matched 1:1 with controls. The primary outcome was the cumulative incidence of LRHF, defined using prevailing Interagency Registry for Mechanically Assisted Circulatory Support criteria; secondary outcomes included all-cause mortality and major bleeding. Results: Among 9627 CF-LVAD recipients analyzed, 2463 (25.6%) received ePDE5i and 1600 were propensity-matched 1:1 with controls. Before implant, ePDE5i patients had more severe RV dysfunction (13.1% versus 9.6%) and higher pulmonary vascular resistance (2.8±2.7 versus 2.2±2.4 WU), both P <0.001, but clinical factors were well-balanced after propensity-matching. In the unmatched cohort, ePDE5i patients had a higher 3-year cumulative incidence of LRHF, mortality, and major bleeding, but these differences were attenuated in the propensity-matched cohort: LRHF 40.8% versus 35.7% (hazard ratio, 1.14 [95% CI, 0.99–1.32]; P =0.07); mortality 38.6% versus 35.8% (hazard ratio, 0.99 [95% CI, 0.86–1.15]; P =0.93); major bleeding 51.2% versus 46.0% (hazard ratio, 1.12 [95% CI, 0.99–1.27]; P =0.06). Conclusions: Compared with propensity-matched controls, adult CF-LVAD patients receiving ePDE5i had similar rates of LRHF, mortality, and major bleeding. While intrinsic patient risk factors likely account for more adverse outcomes with ePDE5i in the unmatched cohort, there is no obvious benefit of ePDE5i in the LVAD population.

Before the 33rd Annual International Society for Heart and Lung Transplantation conference, there was significant intercenter variability in definitions of primary graft dysfunction (PGD). The incidence, risk factors, and outcomes of consensus-defined PGD warrant further investigation. We retrospectively examined 448 adult cardiac transplant recipients at our institution from 2005 to 2017. Patient and procedural characteristics were compared between PGD cases and controls. Multivariable logistic regression was used to model PGD and immediate postoperative high-inotrope requirement for hypothesized risk factors. Patients were followed for a mean 5.3 years to determine longitudinal mortality. The incidence of PGD was 16.5%. No significant differences were found with respect to age, sex, race, body mass index, predicted heart mass mismatch, pretransplant amiodarone therapy, or pretransplant mechanical circulatory support (MCS) between recipients with PGD versus no PGD. Each 10 minute increase in ischemic time was associated with 5% greater odds of PGD (OR = 1.05 [95% CI, 1.00–1.10]; p = 0.049). Pretransplant MCS, predicted heart mass mismatch ≥30%, and pretransplant amiodarone therapy were associated with high-immediate postoperative inotropic requirement. The 30 day, 1 year, and 5 year mortality for patients with PGD were 28.4%, 38.0%, and 45.8%, respectively, compared with 1.9%, 7.1%, and 21.5% for those without PGD (log-rank, p < 0.0001). PGD heralded high 30 day, 1 year, and 5 year mortality. Pretransplant MCS, predicted heart mass mismatch, and amiodarone exposure were associated with high-inotrope requirement, while prolonged ischemic time and multiple perioperative transfusions were associated with consensus-defined PGD, which may have important clinical implications under the revised United Network for Organ Sharing allocation system.

BACKGROUND:A likely consequence of the discontinued distribution and sale of the HVAD System (Medtronic, Minneapolis, MN) will be an increase in replacement with the HeartMate 3 (Abbott, Chicago, IL) left ventricular assist device when device exchange is necessary. If part or all of the HVAD 10-mm-diameter outflow graft is retained during replacement, the HeartMate 3 will have to run at a higher speed than it would with its 14-mm-diameter graft. METHODS:A steady-state, in vitro study was run with 250-mm-long samples of HVAD, HeartMate 3, and half-HVAD/half-HeartMate 3 grafts and additionally 125- and 375-mm-long samples of the HVAD graft. Flows of 3.0, 3.9, 4.3, 4.7, and 6.0 L/min were applied to encompass expected clinical conditions. RESULTS:At typical and high flow rates of 4.3 and 6.0 L/min, HeartMate 3 rotor speeds with the full HVAD graft had to be increased relative to those with the HeartMate 3 graft from 5350 to 5700 and 6350 to 6900 rpm, respectively, with power consumption increases from 3.7 to 4.3 W (16%) and 5.5 to 6.8 W (24%), respectively. CONCLUSIONS:The study did not elucidate a severe consequence of using a remnant HVAD graft during pump exchange, but the incremental risks of a higher rotor speed, disadvantage to the patient in battery runtime, and the general benefit of complete conversion to the HeartMate 3 graft should be balanced against other procedural considerations. Complete graft replacement during HVAD-to-HeartMate 3 conversion remains the preferred approach from an engineering point of view.

Purpose The challenges of predicting right heart failure (RHF) post-Left Ventricular Assist Device (LVAD) may reflect heterogenous underlying pathophysiology. We hypothesized that 1) machine learning (ML) algorithms applied to multidimensional phenotypic data from patients with confirmed post-LVAD RHF will allow identification of distinct RHF phenotypes, 2) identified phenotypes will have unique clinical trajectories. Methods Patients with acute post-LVAD RHF (RVAD and/or ≥ 14 days inotropes post-implant, n=2,550) were identified from the ISHLT Mechanically Assisted Circulatory Support database (n=15,428); and divided into a derivation (DC, n=1,531) and validation cohort (VC, n=1,019). First, unsupervised ML (blinded to clinical outcomes) was applied to 41 pre-implant variables to identify distinct phenotypes. Then, resultant phenotypes were clinically validated by comparing outcomes of 1) RVAD/ death during index hospitalization 2) ICU Length of Stay. Results were validated in the VC. Risk discrimination of existing RHF risk scores was compared between phenotypes. Results Four distinct RHF phenotypes were identified. (Figure 1) Phenotype I had the worst, and Phenotype III had the best outcomes. Results were validated in the VC. RHF risk scores were modestly accurate at predicting RHF in those with severe shock (Phenotype I) pre-implant; but performed poorly for phenotypes without prominent shock. (Table 1) Conclusion ML identifies novel pathophysiological phenotypes of RHF, among which current risk scores were useful to predict RHF only in patients in severe shock prior to implant. The challenges of predicting right heart failure (RHF) post-Left Ventricular Assist Device (LVAD) may reflect heterogenous underlying pathophysiology. We hypothesized that 1) machine learning (ML) algorithms applied to multidimensional phenotypic data from patients with confirmed post-LVAD RHF will allow identification of distinct RHF phenotypes, 2) identified phenotypes will have unique clinical trajectories. Patients with acute post-LVAD RHF (RVAD and/or ≥ 14 days inotropes post-implant, n=2,550) were identified from the ISHLT Mechanically Assisted Circulatory Support database (n=15,428); and divided into a derivation (DC, n=1,531) and validation cohort (VC, n=1,019). First, unsupervised ML (blinded to clinical outcomes) was applied to 41 pre-implant variables to identify distinct phenotypes. Then, resultant phenotypes were clinically validated by comparing outcomes of 1) RVAD/ death during index hospitalization 2) ICU Length of Stay. Results were validated in the VC. Risk discrimination of existing RHF risk scores was compared between phenotypes. Four distinct RHF phenotypes were identified. (Figure 1) Phenotype I had the worst, and Phenotype III had the best outcomes. Results were validated in the VC. RHF risk scores were modestly accurate at predicting RHF in those with severe shock (Phenotype I) pre-implant; but performed poorly for phenotypes without prominent shock. (Table 1) ML identifies novel pathophysiological phenotypes of RHF, among which current risk scores were useful to predict RHF only in patients in severe shock prior to implant.

Introduction: Advanced data analytics are needed to reliably predict bleeding and thrombotic risk in ambulatory left ventricular assist device (LVAD) patients. Hypothesis: Machine learning techniques can be used to predict risk of gastrointestinal bleeding (GIB), stroke, or death in ambulatory LVAD patients. Methods: HeartMate 3 TM LVAD recipients from the MOMENTUM 3 studies with up to 2-year follow-up were included. A multistate model was developed with 5-fold cross-validation to characterize the continuous probability of events after discharge. Model features included pre-implant, index implant, and short- and long-term post-implant clinical features. 85% of patients were used for model derivation and 15% for validation. Model performance was assessed with area under the curve (AUC). With the model features, a risk stratification tool was created by dividing patients’ into terciles of predicted risk. Results: Among 2,056 LVAD patients who survived to hospital discharge, the median age was 59.4 yrs (20.4% Female, 28.6% Black). At 2-years, the incidence of GIB, Stroke, and Death was 25.6%, 6.0% and 12.3%, respectively. Unique models including pre-implant, implant and post-implant features were created for GIB (Figure A), Stroke and Death. In ambulatory LVAD patients, the model could predict 30-day risk of GIB at any time post-implant which was 26.9%, 2.6% and 0.8% in high, medium and low-risk patients respectively (Figure B). Similar risk prediction was performed for stroke and death. The cross-validated AUC in the derivation cohort was 0.70, 0.69, and 0.85 for GIB, stroke, and death respectively. Conclusion: We developed an innovative risk tool informed by machine learning techniques that predicts risk of GIB, stroke, and death at any 30-day interval in ambulatory LVAD patients with readily available clinical data. The model allows for risk stratification that accurately predicts future events and may be useful to guide clinical decision making.

Purpose We aimed to characterize center-specific variability in HeartMate 3 (HM3) patient survival within the MOMENTUM 3 studies and to examine the correlation between implanting center survival and major adverse events (AEs). Methods Center HM3 implant volume during the MOMENTUM 3 pivotal (n=515) and continued access protocol (n=1685) trials were tallied. Centers implanting ≤16 HM3 patients (25th percentile) were excluded. De-identified center variability in mortality was assessed at 90 days and 2 years using direct adjusted survival while accounting for key baseline risk factors. The 90-day frequency and 2-year rates of stroke, bleeding, and infection were compared across centers and correlations between survival and event rate variability were assessed. Results Among 48 centers, 1957 HM3 patients were included in this analysis with site implants ranging between 17 to 103 patients. Patient cohorts differed across the sites by age (average 52-68 years), sex (60-95% male), destination therapy intent (25-100%), and %INTERMACS profile 1-2 (2-81%). At 90 days, center adjusted median mortality was 6.5%, nadiring at ≤3.2% (25th percentile) and peaking at ≥10.5% (75th percentile). Median 2-year center adjusted mortality was 18.6%, nadiring at ≤14.0% and peaking at ≥25.2% (figure A). AEs were also highly variable across centers; centers with low mortality tended to have lower AE rates at 2 years (figure B). Conclusion Patient characteristics and outcomes were highly variable across MOMENTUM 3 centers despite trial preoperative inclusion/exclusion criteria. Many centers had exemplary risk-adjusted HM3 patient outcomes. Studies are needed to improve our understanding of top performing centers' best practices as they relate to HM3 care in the pre, interoperative, and chronic support stages in an effort to further improve HM3 LVAD-associated clinical outcomes.

Background: As left ventricular assist device (LVAD) survival rates continue to improve, evaluating site-specific variability in outcomes can facilitate identifying targets for quality-improvement initiative opportunities in the field. Methods: Deidentified center-specific outcomes were analyzed for HeartMate 3 (HM3) patients enrolled in the MOMENTUM 3 pivotal and continued access protocol trials. Centers < 25th percentile for HM3 volumes were excluded. Variability in risk-adjusted center mortality was assessed at 90 days and 2 years (conditional upon 90-day survival). Adverse event (AE) rates were compared across centers. Results: In the 48 included centers (1958 patients), study-implant volumes ranged between 17 and 106 HM3s. Despite similar trial-inclusion criteria, patient demographics varied across sites, including age quartile ((Q)1 -Q3:57-62 years), sex (73%-85% male), destination therapy intent (60%-84%), and INTERMACS profile 1-2 (16%-48%). Center mortality was highly variable, nadiring at <= 3.6% (<= 25th percentile) and peaking at >= 10.4% (>= 75th percentile) at 90 days and <= 10.2% and >= 18.7%, respectively, at 2 years. Centers with low mortality rates tended to have lower 2-year AE rates, but no center was a top performer for all AEs studied. Conclusions: Mortality and AEs were highly variable across MOMENTUM 3 centers. Studies are needed to improve our understanding of the drivers of outcome variability and to ascertain best practices associated with high-performing centers across the continuum of intraoperative to chronic stages of LVAD support.

We used the International Society for Heart and Lung Transplantation (ISHLT) Registry for Mechanically Assisted Circulatory Support (IMACS) database to examine 1) gender differences in post-left ventricular assist device (LVAD) mortality in the contemporary era and 2) preimplant clinical factors that might mediate any observed differences. Adults who received continuous-flow (CF)-LVAD from January 2013 to September 2017 (n = 9,565, age: 56.2 ± 13.2 years, 21.6% female, 31.1% centrifugal pumps) were analyzed. An inverse probability weighted Cox proportional hazards model was used to estimate association of female gender with all-cause mortality, adjusting for known covariates. Causal mediation analysis was performed to test plausible preimplant mediators mechanistically underlying any association between female gender and mortality. Females had higher mortality after LVAD (adjusted hazard ratio [HR]: 1.36; p < 0.0001), with significant gender × time interaction (p = 0.02). An early period of increased risk was identified, with females experiencing a higher risk of mortality during the first 4 months after implant (adjusted HR: 1.74; p < 0.0001), but not after (adjusted HR: 1.18; p = 0.16). More severe tricuspid regurgitation and smaller left ventricular end-diastolic diameter at baseline mediated ≈21.9% of the increased early hazard of death in females; however, most of the underlying mechanisms remain unexplained. Therefore, females have increased mortality only in the first 4 months after LVAD implantation, partially driven by worsening right ventricular dysfunction and LV-LVAD size mismatch.

Guidelines for pressure injury prevention consider the use of pressure-redistributing pads to prevent tissue deformation. However, limited research exists to assess the pressure distribution provided by the operating tables and the effectiveness of pressure-redistributing pads in preventing pressure injuries. In this study, we compared the pressure distribution properties of two surgical table pads and identified parameters influencing pressure injury outcomes after a lengthy surgical procedure. Twenty-seven patients undergoing left ventricular assist device implantation surgery participated in the study. Participants were randomly assigned to use either an air cell-based pad or a gel pad. Interface pressure was recorded during the surgery. We analyzed the effect of surgical table pad type, interface pressure distribution and pressure injury outcomes and analyzed what characteristics of the patients and the interface pressure are most influential for the development of pressure injuries. Comparing the interface pressure parameters between the air-cell group and the gel group, only the peak pressure index x time was significantly different (p < 0.05). We used univariate logistic regression analysis to identify significant predictors for the pressure injury outcome. The support surface was not significant. And, among patient characteristics, only age and BMI were significant (p ≤ 0.05). Among the interface pressure parameters, pressure density maxima, peak pressure index x time, and coefficient of variation were significant for pressure injury outcome (p ≤ 0.05). Peak pressure index, average pressure, and the surgery length were not statistically significant for pressure injury outcomes.

Background Prior studies have shown that women have worse 3‐month survival after receiving a left ventricular assist device compared with men. Currently used prognostic scores, including the Heartmate II Risk Score, do not account for the increased residual risk in women. We used the IMACS (International Society for Heart and Lung Transplantation Mechanically Assisted Circulatory Support) registry to create and validate a sex‐specific risk score for early mortality in left ventricular assist device recipients. Methods and Results Adult patients with a continuous‐flow LVAD from the IMACS registry were randomly divided into a derivation cohort (DC; n=9113; 21% female) and a validation cohort (VC; n=6074; 21% female). The IMACS Risk Score was developed in the DC to predict 3‐month mortality, from preoperative candidate predictors selected using the Akaike information criterion, or significant sex × variable interaction. In the DC, age, cardiogenic shock at implantation, body mass index, blood urea nitrogen, bilirubin, hemoglobin, albumin, platelet count, left ventricular end‐diastolic diameter, tricuspid regurgitation, dialysis, and major infection before implantation were retained as significant predictors of 3‐month mortality. There was significant ischemic heart failure × sex and platelet count × sex interaction. For each quartile increase in IMACS risk score, men (odds ratio [OR], 1.86; 95% CI, 1.74–2.00; P <0.0001), and women (OR, 1.93; 95% CI, 1.47–2.59; P <0.0001) had higher odds of 3‐month mortality. The IMACS risk score represented a significant improvement over Heartmate II Risk Score (IMACS risk score area under the receiver operating characteristic curve: men: DC, 0.71; 95% CI, 0.69–0.73; VC, 0.69; 95% CI, 0.66–0.72; women: DC, 0.73; 95% CI, 0.70–0.77; VC, 0.71 [95% CI, 0.66–0.76; P <0.01 for improvement in receiver operating characteristic) and provided excellent risk calibration in both sexes. Removal of sex‐specific interaction terms resulted in significant loss of model fit. Conclusions A sex‐specific risk score provides excellent risk prediction in LVAD recipients.

OBJECTIVES:Optimal management of significant mitral regurgitation (SMR) during left ventricular assist device (LVAD) placement remains uncertain. This study evaluates the effect of untreated preop SMR on outcomes following LVAD implant.METHODS:Adults undergoing primary LVAD placement from April 2004 to May 2017 were included. Most recent preop transthoracic echocardiogram (TTE) was used to divide patients into an SMR group with moderate or greater regurgitation, and a group without SMR. Patients underwent LVAD implant without correction of SMR. Primary endpoint was 3-year postoperative survival, with secondary endpoints of length of stay (LOS), resolution of SMR following LVAD on postdischarge (30 day) TTE, and 1-year TTE.RESULTS:LVAD placement was performed in 270 patients, 172 (63.7%) without SMR and 98 (36.3%) with SMR. There were no differences in comorbidities including diabetes, hypertension, and renal disease. Preop ejection fraction was similar, but a higher pulmonary vascular resistance was recorded in the SMR group (3.6 vs 3.0 Wood Units, P = 0.048). There was no difference in 3-year mortality between the 2 cohorts (log-rank P = 0.0.803). The SMR group had decreased LOS (median 19.5 vs 22 days, P = 0.009). Of the 98 SMR patients, 91 (92.9%) had resolution of SMR to less than moderate at 30 days. At 1 year, 15% of those with preoperative SMR had recurrent SMR.CONCLUSIONS:Patients undergoing LVAD placement with preop SMR experience no differences in mortality, and a majority experience resolution of MR after implant. Longer-term SMR recurrence and need for mitral intervention with LVAD implant warrant further investigation.

Objectives: Although adipose-derived stem cells (ADSCs) have shown promise in cardiac regeneration, stable engraftment is still challenging. Acellular bioengineered cardiac patches have shown promise in positively altering ventricular remodeling in ischemic cardiomyopathy. We hypothesized that combining an ADSC sheet approach with a bioengineered patch would enhance ADSC engraftment and positively promote cardiac function compared with either therapy alone in a rat ischemic cardiomyopathy model. Methods: Cardiac patches were generated from poly(ester carbonate urethane) urea and porcine decellularized cardiac extracellular matrix. ADSCs constitutively expressing green fluorescent protein were established from F344 rats and transplanted as a cell sheet over the left ventricle 3 days after left anterior descending artery ligation with or without an overlying cardiac patch. Cardiac function was serially evaluated using echocardiography for 8 weeks, comparing groups with combined cells and patch (group C, n = 9), ADSCs alone (group A, n = 7), patch alone (group P, n = 6) or sham groups (n = 7). Results: Much greater numbers of ADSCs survived in the C versus A groups (P < .01). At 8 weeks posttransplant, the percentage fibrotic area was lower (P < .01) in groups C and P compared with the other groups and vasculature in the peri-infarct zone was greater in group C versus other groups (P < .01), and hepatocyte growth factor expression was higher in group C than in other groups (P < .05). Left ventricular ejection fraction was higher in group C versus other groups. Conclusions: A biodegradable cardiac patch enhanced ADSC engraftment, which was associated with greater cardiac function and neovascularization in the periinfarct zone following subacute myocardial infarction.

HomeCirculationVol. 141, No. 20Outcomes of the First 1300 Adult Heart Transplants in the United States After the Allocation Policy Change Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBOutcomes of the First 1300 Adult Heart Transplants in the United States After the Allocation Policy Change Arman Kilic, MD, Gavin Hickey, MD, Michael A. Mathier, MD, Robert L. Kormos, MD, Ibrahim Sultan, MD, Thomas G. Gleason, MD and Mary E. Keebler, MD Arman KilicArman Kilic Arman Kilic, MD, Division of Cardiac Surgery, University of Pittsburgh Medical Center, 200 Lothrop St, Suite C-700, Pittsburgh, PA 15213. Email E-mail Address: [email protected] https://orcid.org/0000-0001-8112-8345 Heart and Vascular Institute, University of Pittsburgh Medical Center, PA. Search for more papers by this author , Gavin HickeyGavin Hickey Heart and Vascular Institute, University of Pittsburgh Medical Center, PA. Search for more papers by this author , Michael A. MathierMichael A. Mathier Heart and Vascular Institute, University of Pittsburgh Medical Center, PA. Search for more papers by this author , Robert L. KormosRobert L. Kormos Heart and Vascular Institute, University of Pittsburgh Medical Center, PA. Search for more papers by this author , Ibrahim SultanIbrahim Sultan Heart and Vascular Institute, University of Pittsburgh Medical Center, PA. Search for more papers by this author , Thomas G. GleasonThomas G. Gleason Heart and Vascular Institute, University of Pittsburgh Medical Center, PA. Search for more papers by this author and Mary E. KeeblerMary E. Keebler Heart and Vascular Institute, University of Pittsburgh Medical Center, PA. Search for more papers by this author Originally published18 May 2020https://doi.org/10.1161/CIRCULATIONAHA.119.045354Circulation. 2020;141:1662–1664Heart allocation policy was changed on October 18, 2018, to address several concerns with the previous system.1 We reviewed adult heart transplants performed in the United States between January 1, 2018, and March 31, 2019, and stratified patients based on date of waitlist registration and transplantation, with follow-up data through June 6, 2019. Changes in baseline characteristics, as well as waitlist and posttransplant outcomes, were compared. The institutional review board approved this study at the University of Pittsburgh Medical Center.The primary end point was overall survival after transplantation. Secondary end points included waitlist outcomes: waitlist mortality or clinical deterioration, rate of transplantation, and removal from the waitlist because of recovery. Student t test and χ2 tests were used. Time-to-event analyses were performed using the Kaplan-Meier method. Multivariable Cox regression analysis was used for risk adjustment. Waitlist outcomes were analyzed by using competing risks regression and the Fine and Gray method.A total of 3258 adult patients were waitlisted before the policy change and 1759 were waitlisted after the policy change. A total of 2371 and 1311 adult heart transplants were performed before and after the policy change, respectively. After the policy change, recipients were younger (54.3±12.7 versus 52.9±13.2 years; P=0.002) and more had nonischemic dilated cardiomyopathy (50.9% versus 52.0%) and congenital heart disease (3.4% versus 5.3%; P=0.03). Higher risk characteristics, including serum bilirubin (0.91±1.45 versus 1.17±2.44; P<0.001), mechanical ventilation (0.7% versus 2.4%; P<0.001), pretransplant intensive care unit (28.7% versus 47.0%; P<0.001), and bridging with the percutaneous Impella device (0.2% versus 0.6%; P=0.02), intra-aortic balloon pump (IABP; 7.1% versus 22.4%; P<0.001), surgically implanted temporary left ventricular assist devices (LVADs; 1.5% versus 3.9%; P<0.001), or extracorporeal membrane oxygenation (1.1% versus 4.9%; P<0.001) were greater after the policy change. Fewer recipients had durable LVADs after the change (44.8% versus 36.0%; P<0.001). More donors were hepatitis C positive (7.9% versus 11.1%; P=0.001) and had higher creatinine (1.51±1.52 versus 1.65±1.76; P=0.01) in the latter era. There were longer donor-to-recipient hospital distances (156.7±189.4 versus 264.6±241.9 miles; P<0.001) and cold ischemic times (3.02±1.01 versus 3.38±1.02 hours; P<0.001) after the policy change. Under the new policy, the distribution of statuses at transplantation was as follows: 8.6% status 1, 42.8% status 2, 26.2% status 3, 18.3% status 4, 0.3% status 5, and 3.7% status 6.Waitlist outcomes were improved after the policy change, with higher rates of transplantation (P<0.001) and lower rates of waitlist mortality or clinical deterioration (P=0.01; Figure, A and B). Rates of waitlist removal for recovery were low in both groups but lower after the policy change (P=0.01). Posttransplant survival was worse after the policy change, with 6-month survivals of 93.7% versus 86.5% (P<0.001). Similar findings persisted when limiting the analysis to first-time, primary isolated heart transplants (6-month survival: 93.9% versus 88.2%; P<0.001; Figure, C). In multivariable analysis, transplantation after the policy change remained a significant predictor of posttransplant mortality (hazard ratio, 1.41 [95% CI, 1.01–1.95]; P=0.04).Download figureDownload PowerPointFigure. Higher rates of transplantation coupled with lower rates of waitlist mortality or deterioration and lower posttransplant survival after the policy change.A, Transplantation. B, Waitlist mortality or deterioration. C, Overall survival.This study demonstrates substantial changes in the landscape of adult heart transplantation in the United States after the allocation policy change on October 18, 2018. Foremost, higher-risk recipients are undergoing transplantation. This includes mechanically ventilated patients and those bridged with IABP, extracorporeal membrane oxygenation, or temporary LVADs, as well, all of which have been demonstrated to be associated with increased mortality risk after transplantation.2–4 In particular, bridging with IABP has increased >3-fold, suggesting that many programs are favoring the use of IABP when hemodynamically indicated rather than increasing intravenous inotropes or durable LVAD implantation. These changes reflect the priority statuses that are applied under the new system, whereby patients with IABP are prioritized as status 2, and only in the setting of device malfunction, mechanical right ventricular support, or significant ventricular arrhythmias are patients with durable LVADs able to get priority status 1 or 2 listing.The current analysis demonstrates a shift favoring the improvement of waitlist outcomes with a decline in posttransplant survival. This appears to be a reflection of performing transplants in sicker patients with broader sharing of organs and longer ischemic times. The 6-month survival rates we demonstrate after the new policy change are lower than previously reported rates from registry analyses. It is important to note, however, that individual transplant centers are evaluated based on observed-to-expected ratios and not absolute outcomes. The models used for expected risk incorporate many of the risk factors identified as increasing in frequency after the policy change.5 In this manner, the observed-to-expected ratios of outcomes may be maintained despite a decrease in the absolute survival rates after the allocation change. There is also the potential that individual transplant centers may adjust their risk tolerance based on outcomes. This is an early analysis with associated limitations in follow-up after the policy change, and a reevaluation of these outcomes will therefore be essential.AcknowledgmentsThe data reported here have been supplied by the United Network for Organ Sharing as the contractor for the Organ Procurement and Transplantation Network. The interpretation and reporting of these data are the responsibility of the authors and in no way should be seen as an official policy of or interpretation by the Organ Procurement and Transplantation Network or the US government.DisclosuresDr Kilic is on the Medical Advisory Board, Medtronic, Inc. Dr Kormos is a current employee at Abbott, Inc, although this work was done during his time at the University of Pittsburgh. Dr Gleason is on the Medical Advisory Board, Abbott, Inc. Dr Keebler is a consultant at Abbott, Inc, and on the Medical Advisory Board, Medtronic, Inc. There are no conflicts of interest as they pertain directly to this article.FootnotesData sharing: The authors declare that all supporting data are available within the article.https://www.ahajournals.org/journal/circArman Kilic, MD, Division of Cardiac Surgery, University of Pittsburgh Medical Center, 200 Lothrop St, Suite C-700, Pittsburgh, PA 15213. Email [email protected]eduReferences1. 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May 19, 2020Vol 141, Issue 20 Advertisement Article InformationMetrics © 2020 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.119.045354PMID: 32421414 Originally publishedMay 18, 2020 Keywordsheart failureresource allocationheart transplantationtreatment outcomesPDF download Advertisement SubjectsCardiovascular SurgeryTransplantation

Women approached who did not enroll in SUSTAIN-IT were more likely than men to refuse to participate. Reasons for refusal varied for both women and men based on type of advanced HF therapy. Our novel findings may provide tailored guidance when recruiting men and women in clinical trials.

CG- and not PT-specific factors were related to CG QOL prior to HT and DT MCS. Awareness of these factors may foster support of CGs.

Background: Ventricular assist device (VAD) patients are at high risk for morbidities and mortality. One potentially beneficial component of the Joint Commission VAD Certification process is the requirement that individual VAD programs select 4 performance measures to improve and optimize patients’ clinical outcomes. Problem Statement: Review of patient data after our program’s first certification visit in 2008 showed that, compared to national recommendations and published reports, our patients had suboptimal outcomes in 4 areas after device implantation: length of hospital stay, receipt of early (<48 hours) postsurgical physical therapy, driveline infection incidence, and adequacy of nutritional status (prealbumin ≥18 mg/dL). Methods: Plan-Do-Study-Act processes were implemented to shorten length of stay, increase patient receipt of early physical therapy, decrease driveline infection incidence, and improve nutritional status. With 2008 as our baseline, we deployed interventions for each outcome area across 2009 to 2017. Performance improvement activities included staff, patient, and family didactic, one-on-one, and hands-on education; procedural changes; and outcomes monitoring with feedback to staff on progress. Descriptive and inferential statistics were examined to document change in the outcomes. Outcomes: Across the performance improvement period, length of stay decreased from 40 to 23 days; physical therapy consults increased from 87% to 100% of patients; 1-year driveline infection incidence went from 38% to 23.5%; and the percentage of patients with prealbumin within the normal range increased from 84% to 90%. Implications: Performance improvement interventions may enhance ventricular assist device patient outcomes. Interventions’ sustainability should be evaluated to ensure that gains are not lost over time.

[This corrects the article DOI: 10.2196/14701.].