Title Waitlist and Heart Transplant Outcomes By Sex Are Similar In Hypertrophic Cardiomyopathy Patients After The 2018 UNOS Donor Heart Allocation Policy Introduction and Hypothesis Hypertrophic cardiomyopathy (HCM) does not have a predilection for gender; however, underrecognition and delayed diagnosis disproportionately affects women, leading to higher incidence of advanced heart failure. End stage HCM (non-obstructive) is an increasing cause of morbidity and mortality, with HCM patients accounting for 3.5% of heart transplant (HT) recipients. Recent changes in the UNOS donor heart allocation policy acknowledged the unique pathophysiology of HCM-related advanced heart failure and led to an increase in the number of transplants. This study aims to investigate sex-based differences in HCM patients undergoing HT following the adoption of the 2018 UNOS donor heart allocation policy. Methods HCM patients in the UNOS database who were listed for HT between 10-18-2018 and 06-30-2023 were included in the study. Heart re-transplant, multi-organ listings and candidates listed for organs other than heart were excluded. Patients were classified according to female (F) or male (M) sex. Clinical characteristics at the time of listing, HT and post-transplant survival were compared between male and female recipients. Results A total of 560 patients (233 female, 327 male) were included in the study. One year post transplant adjusted survival was similar (97.7% F, 98.2% M; p=0.562). However, the study found statistically significant differences in age at HT (48.9±13.18 y F vs 52.28±12.09 y M; p=0.009), with no difference in HT rate 1 year after listing (74.6% F, 76.1% M; p=0.5). Distribution of Listing Status was different by sex at time of listing (p=0.001) and transplant (p<0.001), with a greater proportion of males assigned Status 1-2 whereas the majority of females were Status 4. An underlying reason may be a higher proportion of males on IABP (24.1% M vs 12.43% F; p=0.005) and inotropes (38.55% M vs 21.3% F; p<0.001). Small differences in hemodynamic parameters did not appear clinically significant to account for the increased utilization of mechanical/inotropic support. However, the number of days waiting for HT was (97.01±161.6 F vs 96.89±156.2 M; p=0.775). Conclusions Survival one year post HT in patients with HCM was similar in females and males, indicating that the 2018 donor heart allocation policy is not disproportionately affecting mortality outcomes by sex. This analysis raises the question of how both sexes have similar wait time despite males being assigned higher status levels at listing and transplant. One possible explanation for this could be differences in donor heart size requirements between males and females. Further investigation is necessary to explore and adjust for contributing factors.
Introduction Patients with heart failure and reduced ejection fraction (HFrEF) are at increased risk of ventricular tachycardia (VT) and sudden cardiac death (SCD). Catheter ablation of VT is a treatment alternative for patients with recurrent VT despite antiarrhythmics. HFrEF patients undergoing VT ablation represent a high-risk population that may benefit from risk stratification for advanced HF therapies, such as left ventricular assist device (LVAD) implantation or heart transplantation (HTx). Our objective was to evaluate the clinical characteristics and long-term outcomes of HFrEF patients undergoing VT ablation at our institution. Methods Patients with HFrEF (EF < 40%) who received VT ablation between January, 2018 and May, 2023 at our institution were included. Epidemiological, echocardiographic, and clinical variables were collected. The Kaplan-Meier method was used for survival analysis, outcomes included mortality, LVAD implantation and HTx. Statistical analysis of the association between clinical characteristics and outcomes was performed with Student's t-test, the Wilcoxon signed rank test, Fisher's exact test, or Chi-squared test. Statistical significance was considered if p<0.05. Results A total of 110 patients were included in this study. There are 27 patients reached the primary outcome. Among whom, 26 patients died, 1 patient received an LVAD and heart transplant. The 3 years survival rate was 75.5% (Figure 1). Patients who achieved the primary outcome were classified as non-survivors and the remaining patients are classified ad survivors. Epidemiological, clinical and echocardiographic variables of the two groups are shown in Table 1. The non-survivors cohort has lower blood pressure, higher incidence of chronic kidney disease, larger percentage of NYHA class III/IV, lower left ventricular ejection fraction, more mitral valvular dysfunction, worse right ventricular systolic reduction, and more hospitalization peri-ablation. Conclusions Patients with HFrEF undergoing VT ablation are a high-risk population with 1 in every 4 patients either dying or requiring LVAD or HT within 3 years. They require close monitoring and multidisciplinary management from electrophysiologists and advanced HF cardiologists, especially for the early identification of candidates who may benefit from advanced HF therapies.
Introduction Patients with ischemic cardiomyopathy and obstructive coronary artery disease associated with chronic total occlusion (CTO) of the coronary arteries are considered high risk for surgical revascularization given the concomitant presence of heart failure and reduced ejection fraction (HFrEF). With current technology, revascularization via percutaneous coronary intervention (PCI) of the CTO is possible. Most reports of these procedures have focused on the immediate success, complications, or the short-term outcomes. The objective of our study was to evaluate the clinical characteristics and long term outcomes of patients with HFrEF who underwent percutaneous revascularization of CTO coronary artery. Methods This retrospective study reviewed all patients with HFrEF (≤40%) who underwent PCI of the CTO from January 2015 to September 2023 at our institution. Epidemiologic, clinical, echocardiographic, and hemodynamic characteristics were obtained before and after PCI. Survival analysis was performed using Kaplan-Meier methodology (figure 1a). Comparisons between survivors and non-survivors were performed using standard statistical techniques with statistical significance identified when p <0.05. Results A total of 65 patients were included in the study. The median age was 64(59-68) years, 80% were males, with a mean LVEF of 31 ± 8% and a LVDD of 5.7 ± 0.7 cm, prior to CTO procedure. A total of 42% had ICD or CRT devices. Comorbidities included diabetes mellitus (63%), atrial fibrillation (25%), history of cerebrovascular accident (12%), history of heart valve repair or replacement (6%), history of cancer other than skin cancer (29%), chronic obstructive pulmonary disease (29%), and on home oxygen (3%). A total of 11 patients died during the follow-up period. Importantly, survivors experienced a significant[NM1] increase in LVEF (8.1±12.6%) after CTO procedure, whereas non-survivors did not (figure 1b). Non-survivors had an increased frequency of oxygen dependence at the time of CTO procedure. The survival at 5 years post CTO-PCI procedure was 58%. Only one patient of the overall cohort received a cardiomems device for monitoring of pulmonary artery pressures. Conclusion Patients with HFrEF and obstructive coronary artery disease who underwent a CTO-PCI of a coronary artery, represent a high risk population with a high mortality in the long term follow-up. Increase in LVEF after CTO revascularization was associated with survival. Close collaboration between Advanced heart Failure and Interventional Cardiology is necessary to identify patients at risk of poor outcomes and the possibility to offer advanced heart failure therapies.
Introduction Guidelines for heart failure with reduced ejection fraction (HFrEF) recommend 4 pillars of pharmacotherapy to reduce morbidity and mortality. Observational data consistently report an underutilization of GDMT-4 and dosing below target. The goal of the pharmacist-led GDMT clinic is to improve utilization of medications and optimization to the target dose or the patient's maximum tolerated dose in an expedited and safe manner. Objective To assess the impact of a pharmacist-led GDMT clinic on achievement of optimal GDMT-4 doses and improvement in EF. Methods Patients ≥ 18 yo with HFrEF (EF < 40%) referred by a HF provider to a pharmacist embedded within the HF clinic for GDMT optimization from 10/2022 - 12/2023 were analyzed. Patients receiving dialysis, pregnant or congenital heart conditions were excluded. The pharmacist works under a collaborative practice agreement which allows for prescribing of medication and ordering of labs. The goal is to have patients on target doses of the 4 pillars by the end of 12 weeks. Over the 12 weeks, patient appointments are in-person or telephone calls. In-person appointments are shared with a registered nurse, who completes a physical exam, obtains a medication history, and draws labs as needed. The pharmacist then reviews current GDMT therapy, vital signs, signs and symptoms of HF and adjusts medications as appropriate. Patient concerns with medication adherence or financial barriers are addressed along with social barriers if applicable. Target doses were defined as sacubitril/valsartan 97/103mg twice daily, losartan 50mg or greater daily, lisinopril 40mg daily, metoprolol succinate 200mg daily, carvedilol 25mg twice daily, spironolactone 25mg daily or eplerenone 50mg daily and dapagliflozin or empagliflozin 10mg daily. Results Over the study period, 132 patients graduated from the GDMT clinic. Ninety-nine (74%) were male and 32 (24%) had a diagnosis of ischemic cardiomyopathy and baseline EF of 23 ± 8.54%. Patients averaged 9±3.7 weekly appointments which resulted in 27 (20%) patients being on target doses for all 4 pillars and 94 (71%) patients on all 4 pillars at any dose. Upon follow up, there were improvements in EF with 44% (n=58) of patients achieving EF of ≥ 10% above baseline to ≥ 40%. Three patients were hospitalized for HF during or up to 90 days after GDMT titration, and 3 patients died within 90 days completing GDMT appointments. Conclusions A pharmacist-led GMDT titration clinic within a HF clinic led to increased number of patients achieving target doses of medications within 12 weeks with significant improvement in EF. Further studies will explore comparisons with standard office visits and implications for best practices for HF management.
Introduction The heart transplant (HT) allocation implemented in 2018 resulted in reduced waitlist times, increased rates of transplantation, and a wider geographic range of organ allocation. The impact of the allocation system on rural communities has not been evaluated. We compared the outcomes in the waitlist and after transplantation in rural and urban communities in the current and prior allocation systems. Methods Adult patients listed for HT in UNOS from 1/1/2014-12/31/2021 were enrolled. Patients undergoing re-transplantation or multi-organ transplantation were excluded. Patients were then categorized in rural or urban residence according to zip code. Patients were categorized in the prior or current allocation system depending on whether they were listed before or after Oct 18, 2018. Cumulative Incidence (CI) of outcomes in the waitlist (transplantation or death/delisting due to worsening clinical status) were calculated. One-year survival after HT was calculated using Kaplan-Meier methodology. Comparisons between rural and urban residents in the prior and current allocation systems were performed before and after adjustment for risk factors. Results A total of 26450 patients were listed for HT, of which 59.6% and 40.4% were listed in the prior and current allocation systems, respectively; 17796 patients underwent transplantation. Of the 15761 listed under the previous UNOS policy, 19.2% were of rural residence and 80.8% urban; of the 10689 listed under the current policy, 18.9% were rural and 81.1% urban. Of the patients that underwent transplant, 9424 were listed under the previous system with 18.9% rural and 81.1% urban; 8372 were listed under the current system with 18% rural and 82% urban. In the prior allocation system the CI of death/delisting and transplantation was not different between rural or urban residents in the unadjusted or adjusted models. In the current system the unadjusted models demonstrated a trend towards higher CI of death/delisting for rural residents (7.4% vs 6.2%; p=0.06) and lower CI of heart transplant (65.8% vs 68.2%; p=0.07). In adjusted models rural residence was independently associated with a higher CI of death/delisting(HR 1.29 95% CI 1.06-1.57; p=0.01). In addition, rural residents had a higher CI of transplantation (HR 1.09 95% CI 1.02-1.17; p=0.011). The adjusted and unadjusted post-transplant survival were similar between rural and urban residents both in the prior and current systems. Conclusions While the change in the UNOS heart organ allocation system has resulted in some benefits, it may be associated with inequitable geographical bias towards increased death/delisting in rural residents and decreased HT amongst urban. The cause of these potential inequities requires further investigation. The 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 author(s) and in no way should be seen as an official policy of or interpretation by the OPTN or the U.S. Government.
Background The study objective was to assess disparities in outcomes in the waitlist and post-heart transplantation (HT) according to socioeconomic status (SES) in the old and new U.S. HT allocation systems. Methods Adult HT candidates in the United Network for Organ Sharing database from 2014 through 2021 were included. Old or new system classification was according to listing before or after October 18, 2018. SES was stratified by patient ZIP code and median household income via U.S. Census Bureau and classified into terciles. Competing waitlist outcomes and post-transplantation survival were compared between systems. Results In total, 26,450 patients were included. Waitlisted candidates with low SES were more frequently younger, female, African American, and with higher body mass index. Reduced cumulative incidence (CI) of HT in the old system occurred in low SES (53.5%) compared to middle (55.7%, p = 0.046), and high (57.9%, p < 0.001). In the new system, the CI of HT was 65.3% in the low SES vs middle (67.6%, p = 0.002) and high (70.2%, p < 0.001), and SES remained significant in the adjusted analysis. In the old system, CI of death/delisting was similar across SES. In the new system, low SES had increased CI of death/delisting (7.4%) vs middle (6%, p = 0.012) and high (5.4%, p = 0.002). The old system showed similar 1-year survival across SES. In the new system, recipients with low SES had decreased 1-year survival (p = 0.041). Conclusions SES affects waitlist and post-transplant outcomes. In the new system, all SES had increased access to HT; however, low SES had increased death/delisting due to worsening clinical status and decreased post-transplant survival.
OBJECTIVE:Our study aimed to assess the heart failure/cardiomyopathy-related population-level mortality trends among patients with obesity in the United States and disparities across demographics. METHODS:We queried the Centers for Disease Control and Prevention's Wide-Ranging Online Data for Epidemiologic Research database among adults aged ≥25 from 1999 to 2019. Heart failure/cardiomyopathy were listed as the main causes of death, with obesity as a contributing cause. We calculated age-adjusted mortality rates (AAMR) per 100,000 individuals and estimated the average annual percent change (AAPC). We also evaluated the social vulnerability of United States counties (2014-2018). RESULTS:There were 29,334 deaths related to heart failure/cardiomyopathy among patients with comorbid obesity. The overall AAMR increased from 0.41 in 1999 to 0.94 in 2019, with an AAPC of 3.78 (95 % CI, 3.41-4.14). The crude mortality rate increase for heart failure/cardiomyopathy was greater in individuals with comorbid obesity than in those without. Males had a higher AAMR than females (0.78 vs 0.55). African Americans also had higher AAMR than Whites (1.35 vs 0.62). The AAMR was higher in rural areas than in urban regions (0.76 vs 0.66). The overall AAMR was higher in counties with social vulnerability index-Quartile 4 (SVI-Q4) (most vulnerable) (1.08) compared to SVI-Q1 (least vulnerable) (0.63) with a risk ratio of 1.71 (95 % CI: 1.61-1.83). CONCLUSION:Heart failure/cardiomyopathy mortality in individuals with comorbid obesity was rising. Males, African Americans, and individuals from rural regions had higher AAMR than their counterparts.
This case series underscores the crucial role of genetic testing and a multidisciplinary approach to the management of genetic dilated cardiomyopathy. It also highlights the importance of distinguishing dilated cardiomyopathies from other cardiomyopathies to personalize patient care.
Purpose The new heart transplant (HT) allocation system prioritizes cardiogenic shock patients on temporary mechanical circulatory support(tMCS). Intra-aortic balloon pumps (IABP) are now frequently used as a bridge to transplant (BTT). Detailed criteria were developed to appropriately categorize patients who qualify for IABP support. Clinicians may request exception status for patients who do not fit the predetermined prioritization criteria. The purpose of our study was to evaluate the clinical characteristics and outcomes of patients BTT with an IABP under an exception status. Methods Adult patients who were supported by IABP and received HT between 10/18/2018 and 12/31/2020 were included in this study. Patients were stratified according to the request for exception status at the time of transplantation. Recipient and donor characteristics were compared between groups. One-year post-transplant survival was calculated with Kaplan-Meier methodology.* Results A total of 1423 patients met our inclusion criteria. Of these 580 (40.7%) patients were transplanted utilizing an exception status. IABP-exception patients were more likely to be Black (27.2% vs. 22.3%, p=0.014), had a higher BMI (27.5±4.9 vs. 26.3±4.8, kg/m2, p=<0.001), more days on the waitlist (18 (7-59) vs. 9 (4-20), p<0.001). IABP-exception patients were more likely to receive a male-donor heart (82.8% vs. 78%, p=0.032), and had a lower frequency of gender mismatch (24.3% vs. 19.1%, p=0.025). There were no differences in age (54.2±12 vs. 54.4±12.5 years, p=0.632), male gender (77.4% vs. 73%, p=0.064), proportion of inotropic use (61.7% vs. 62.7%, p=0.761), or ischemic time (3.6±1 vs 3.5±0.9 hrs., p=0.149). The one-year survival after HT was lower in the IABP-exception group (91% vs. 94.8%, p=0.004) (Figure). Conclusion Forty percent of IABP patients received HT under an exception status. These patients had longer waitlist time and had worse post-transplant survival. Further studies to define the reasons for the use of exception status in the IABP population are required. The new heart transplant (HT) allocation system prioritizes cardiogenic shock patients on temporary mechanical circulatory support(tMCS). Intra-aortic balloon pumps (IABP) are now frequently used as a bridge to transplant (BTT). Detailed criteria were developed to appropriately categorize patients who qualify for IABP support. Clinicians may request exception status for patients who do not fit the predetermined prioritization criteria. The purpose of our study was to evaluate the clinical characteristics and outcomes of patients BTT with an IABP under an exception status. Adult patients who were supported by IABP and received HT between 10/18/2018 and 12/31/2020 were included in this study. Patients were stratified according to the request for exception status at the time of transplantation. Recipient and donor characteristics were compared between groups. One-year post-transplant survival was calculated with Kaplan-Meier methodology.* A total of 1423 patients met our inclusion criteria. Of these 580 (40.7%) patients were transplanted utilizing an exception status. IABP-exception patients were more likely to be Black (27.2% vs. 22.3%, p=0.014), had a higher BMI (27.5±4.9 vs. 26.3±4.8, kg/m2, p=<0.001), more days on the waitlist (18 (7-59) vs. 9 (4-20), p<0.001). IABP-exception patients were more likely to receive a male-donor heart (82.8% vs. 78%, p=0.032), and had a lower frequency of gender mismatch (24.3% vs. 19.1%, p=0.025). There were no differences in age (54.2±12 vs. 54.4±12.5 years, p=0.632), male gender (77.4% vs. 73%, p=0.064), proportion of inotropic use (61.7% vs. 62.7%, p=0.761), or ischemic time (3.6±1 vs 3.5±0.9 hrs., p=0.149). The one-year survival after HT was lower in the IABP-exception group (91% vs. 94.8%, p=0.004) (Figure). Forty percent of IABP patients received HT under an exception status. These patients had longer waitlist time and had worse post-transplant survival. Further studies to define the reasons for the use of exception status in the IABP population are required.
Purpose Patients supported by left ventricular assist device (LVAD) listed for heart transplant (HT) have a decreased frequency of transplantation, and increased frequency of exception status requests. The purpose of our study was to understand the reason for exception requests and their impact on post-transplant outcomes. Methods Adult patients who received HT while on durable LVAD support between October 18, 2018, and December 31, 2020, were included in this study. Patients were stratified according to the request of an exception status at the time of HT. Clinical characteristics at the time of transplant and post-transplant outcomes were compared between groups. The narratives for exceptions status requests were reviewed.* Results A total of 1120 patients were included in the analysis. Of these, 170 (15.2%) had an exception status at the time of HT. There were significant differences between Non-Exception and Exception LVAD patients (Table 1). In summary, LVAD-Exception patients were more likely to be male, blood type O, on inotropic support, have higher pulmonary artery and pulmonary capillary wedge pressures, and more likely to be supported on HM-2 or HVAD. They were more likely to receive a heart from a younger, male, and undersized donor. In addition, ischemic time and distance from donor hospital were greater in these patients (Table). The most common cause for exception request was right ventricular failure (34.1%), followed by arrhythmia (20%), infection (17.1%), thrombosis (14.7%), device malfunction (5.3%), bleeding (2.9%), aortic regurgitation (2.4%), stroke (1.8%), and multiple causes (1.8%). The 1-year post-transplant survival was similar between exception and non-exceptions status (89.8% vs. 88.2%, p=0.517). Conclusion The current HT allocation system does not appropriately prioritize a significant proportion of patients, thus requiring an exception status. LVAD patients who received HT under an exception status share multiple characteristics associated with prolonged waitlist. Right ventricular failure and arrhythmias are the most common causes for exception request. Patients supported by left ventricular assist device (LVAD) listed for heart transplant (HT) have a decreased frequency of transplantation, and increased frequency of exception status requests. The purpose of our study was to understand the reason for exception requests and their impact on post-transplant outcomes. Adult patients who received HT while on durable LVAD support between October 18, 2018, and December 31, 2020, were included in this study. Patients were stratified according to the request of an exception status at the time of HT. Clinical characteristics at the time of transplant and post-transplant outcomes were compared between groups. The narratives for exceptions status requests were reviewed.* A total of 1120 patients were included in the analysis. Of these, 170 (15.2%) had an exception status at the time of HT. There were significant differences between Non-Exception and Exception LVAD patients (Table 1). In summary, LVAD-Exception patients were more likely to be male, blood type O, on inotropic support, have higher pulmonary artery and pulmonary capillary wedge pressures, and more likely to be supported on HM-2 or HVAD. They were more likely to receive a heart from a younger, male, and undersized donor. In addition, ischemic time and distance from donor hospital were greater in these patients (Table). The most common cause for exception request was right ventricular failure (34.1%), followed by arrhythmia (20%), infection (17.1%), thrombosis (14.7%), device malfunction (5.3%), bleeding (2.9%), aortic regurgitation (2.4%), stroke (1.8%), and multiple causes (1.8%). The 1-year post-transplant survival was similar between exception and non-exceptions status (89.8% vs. 88.2%, p=0.517). The current HT allocation system does not appropriately prioritize a significant proportion of patients, thus requiring an exception status. LVAD patients who received HT under an exception status share multiple characteristics associated with prolonged waitlist. Right ventricular failure and arrhythmias are the most common causes for exception request.
HeartMate 3 is the only durable left ventricular assist devices (LVAD) currently implanted in the United States. The purpose of this study was to develop a predictive model for 1 year mortality of HeartMate 3 implanted patients, comparing standard statistical techniques and machine learning algorithms. Adult patients registered in the Society of Thoracic Surgeons, Interagency Registry for Mechanically Assisted Circulatory Support (STS-INTERMACS) database, who received primary implant with a HeartMate 3 between January 1, 2017, and December 31, 2019, were included. Epidemiological, clinical, hemodynamic, and echocardiographic characteristics were analyzed. Standard logistic regression and machine learning (elastic net and neural network) were used to predict 1 year survival. A total of 3,853 patients were included. Of these, 493 (12.8%) died within 1 year after implantation. Standard logistic regression identified age, Model End Stage Liver Disease (MELD)-XI score, right arterial (RA) pressure, INTERMACS profile, heart rate, and etiology of heart failure (HF), as important predictor factors for 1 year mortality with an area under the curve (AUC): 0.72 (0.66-0.77). This predictive model was noninferior to the ones developed using the elastic net or neural network. Standard statistical techniques were noninferior to neural networks and elastic net in predicting 1 year survival after HeartMate 3 implantation. The benefit of using machine-learning algorithms in the prediction of outcomes may depend on the type of dataset used for analysis.
Purpose The new heart transplant (HT) allocation system provides detailed criteria for prioritization of listing status for patients with cardiac amyloidosis. An increased use of exception status has been described in the new HT system. The objective of our study was to describe the clinical characteristics and post-transplant outcomes of patients with cardiac amyloidosis according to the request of exception status. Methods Adult patients who were listed and received a HT due to cardiac amyloidosis between October 18, 2018, and December 31, 2020, were included in this study. Patients were stratified according to the request of an exception status at the time of HT. Clinical characteristics at the time of transplant and post-transplant outcomes were compared between groups. The exceptions status narratives were reviewed to determine the adherence to the pre-specified criteria.* Results A total of 107 cardiac amyloid patients received HT during the study period. Of these, 47 (43.9%) had an exception status at the time of HT. Patient and donor characteristics were similar between groups (table). Most exception patients were transplanted at status 2 (n=33), most of which were supported by IABP (n=22). Of the patients transplanted with an exception status 31 were ATTR,13 were AL amyloid, and 3 were non-specified. Eighteen (38.2%) patients who were transplanted as an exception status did not meet the pre-specified criteria developed for amyloidosis. Arrhythmias and not meeting hypotension parameters were the most common cause for the request of Ad Hoc exception requests. The one-year survival post-transplantation was similar between exception and non-exception groups (93.3% vs. 95.7%, p=0.65). Conclusion A large proportion of cardiac amyloid patients are transplanted utilizing an exception status. One third of these patients do not meet the pre-specified criteria for exception status and require Ad Hoc exception request. Exception status is not associated with changes in one-year post-transplant survival. The new heart transplant (HT) allocation system provides detailed criteria for prioritization of listing status for patients with cardiac amyloidosis. An increased use of exception status has been described in the new HT system. The objective of our study was to describe the clinical characteristics and post-transplant outcomes of patients with cardiac amyloidosis according to the request of exception status. Adult patients who were listed and received a HT due to cardiac amyloidosis between October 18, 2018, and December 31, 2020, were included in this study. Patients were stratified according to the request of an exception status at the time of HT. Clinical characteristics at the time of transplant and post-transplant outcomes were compared between groups. The exceptions status narratives were reviewed to determine the adherence to the pre-specified criteria.* A total of 107 cardiac amyloid patients received HT during the study period. Of these, 47 (43.9%) had an exception status at the time of HT. Patient and donor characteristics were similar between groups (table). Most exception patients were transplanted at status 2 (n=33), most of which were supported by IABP (n=22). Of the patients transplanted with an exception status 31 were ATTR,13 were AL amyloid, and 3 were non-specified. Eighteen (38.2%) patients who were transplanted as an exception status did not meet the pre-specified criteria developed for amyloidosis. Arrhythmias and not meeting hypotension parameters were the most common cause for the request of Ad Hoc exception requests. The one-year survival post-transplantation was similar between exception and non-exception groups (93.3% vs. 95.7%, p=0.65). A large proportion of cardiac amyloid patients are transplanted utilizing an exception status. One third of these patients do not meet the pre-specified criteria for exception status and require Ad Hoc exception request. Exception status is not associated with changes in one-year post-transplant survival.
Purpose To evaluate the effect of the new heart transplant (HT) allocation system in left ventricular assist device (LVAD) supported patients listed as bridge to transplantation (BTT). Methods Adult patients who were listed for HT between October 18, 2016 and October 17, 2019, and were supported with an LVAD, enrolled in the UNOS database were included in this study. Patients were classified in the old or new system if they were listed or transplanted before or after October 18, 2018, respectively. Results A total of 3261 LVAD patients were listed for transplant. Of these, 2257 were classified in the old and 1004 in the new system. The cumulative incidence of death or removal from the transplant list due to worsening clinical status at 360-days after listing was lower in the new system (4% vs. 7%, P = .011). LVAD Patients listed in the new system had a lower frequency of transplantation within 360-days of listing (52% vs. 61%, P < .001). A total of 1843 LVAD patients were transplanted, 1004 patients in the old system and 839 patients in the new system. The post-transplant survival at 360 days was similar between old and new systems (92.3% vs. 90%, P = .08). However, LVAD patients transplanted in the new system had lower frequency of the combined endpoint, freedom of death or re-transplantation at 360 days (92.2% vs. 89.6%, P = .046). Conclusion The new HT allocation system has affected the LVAD-BTT population significantly. On the waitlist, LVAD patients have a decreased cumulative frequency of transplantation and a concomitant decrease in death or delisting due to worsening status. In the new system, LVAD patients have a decreased survival free of re-transplantation at 360 days post-transplant.
Purpose To compare the clinical, epidemiological characteristics, waitlist and post-transplant outcomes in patients that were listed at the lowest priority status, before (status 2) and after (status 6) the new UNOS heart transplant (HT) allocation system. Methods Adult patients listed for HT as status 2 in the old allocation system from October 18, 2016 to October 17, 2018 and as status 6 in the new allocation system from October 18, 2018 to October 17, 2019 were included in the study. Clinical characteristics at listing and at the time of transplant were compared between both groups. Competing outcomes in the waitlist (death/removal from the waitlist, transplantation, or alive) and post-transplant survival were compared between old and new systems. Results A total of 2825 patients were listed for HT. Of these, 1956 were listed as status 2 in the old system, and 869 were listed as status 6 in the new system. Patients listed in the new system were older and had a higher frequency of inotropic support at the time of listing. The cumulative incidence of transplantation was higher in patients listed in the new system (51% vs. 44%, p<0.001). Being listed in the new system was an independent factor associated with transplantation (HR: 1.33 (1.17-1.52). A total of 679 and 424 patients received HT in the old and new systems, respectively. The waitlist time was shorter, and the ischemic time was longer in the new allocation system. The 180 days post-transplant survival was similar between old and new systems (93.1% vs. 94.5%, p=0.369). Conclusion With the implementation of the new HT allocation system, patients listed at the lowest priority status have a shorter waitlist time and increased incidence of HT without differences in the post-transplant survival. To compare the clinical, epidemiological characteristics, waitlist and post-transplant outcomes in patients that were listed at the lowest priority status, before (status 2) and after (status 6) the new UNOS heart transplant (HT) allocation system. Adult patients listed for HT as status 2 in the old allocation system from October 18, 2016 to October 17, 2018 and as status 6 in the new allocation system from October 18, 2018 to October 17, 2019 were included in the study. Clinical characteristics at listing and at the time of transplant were compared between both groups. Competing outcomes in the waitlist (death/removal from the waitlist, transplantation, or alive) and post-transplant survival were compared between old and new systems. A total of 2825 patients were listed for HT. Of these, 1956 were listed as status 2 in the old system, and 869 were listed as status 6 in the new system. Patients listed in the new system were older and had a higher frequency of inotropic support at the time of listing. The cumulative incidence of transplantation was higher in patients listed in the new system (51% vs. 44%, p<0.001). Being listed in the new system was an independent factor associated with transplantation (HR: 1.33 (1.17-1.52). A total of 679 and 424 patients received HT in the old and new systems, respectively. The waitlist time was shorter, and the ischemic time was longer in the new allocation system. The 180 days post-transplant survival was similar between old and new systems (93.1% vs. 94.5%, p=0.369). With the implementation of the new HT allocation system, patients listed at the lowest priority status have a shorter waitlist time and increased incidence of HT without differences in the post-transplant survival.
"Does advanced heart failure mean that there is no hope for my medical condition?" "Is it true that I not only have heart failure, but advanced heart failure? What does that mean?" These are only a sampling of numerous comments we have received from surveys our advanced heart failure clinic periodically sends out to patients. It is not uncommon when I meet patients for the first time in the office that I see their eyes stare at my white coat reading the label "Advanced Heart Failure." Thus, from the beginning, we are fighting an uphill battle to help patients and families understand their heart condition. "Advanced Heart Failure" conveys a sense of despair that not much can be done to help them. The truth of the matter is a lot can be done.
Historically, adult congenital patients have longer waitlist time and worse outcomes on the heart transplant waitlist as well as poorer early post‐transplant survival. A new heart transplantation allocation system was implemented in the United States on October 18, 2018. The effect of the new allocation system on adult congenital patients is unknown. Adult congenital patients listed for transplantation between November 1, 2015 and September 30, 2019 registered in the United Network for Organ Sharing were included in the study. October 18, 2018 was used as the limit to distribute listed and transplanted patients into old and new groups. A total of 399 patients were listed for heart transplant only, 284 in the old system and 115 in the new system. Clinical characteristics were similar between both groups. The cumulative incidence of poor outcome on the transplant list was similar in both groups ( P = .23), but the cumulative incidence of transplant was higher in the new system group ( P < .009) and was associated with a shorter waitlist time. The one‐year post‐transplant outcome was similar between old and new groups ( P = .37). The new allocation system has benefited adult congenital patients with increased cumulative frequency of transplantation without worsening short‐term survival after transplantation.
Historically, patients with restrictive (RCM) and hypertrophic cardiomyopathy (HCM) experienced longer wait-times for heart transplant (HT) and increased waitlist mortality. Recently, a new HT allocation system was implemented in the United States. We sought to determine the impact of the new HT system on RCM/HCM patients. Adult patients with RCM/HCM listed for HT between November 2015 and September 2019 were identified from the UNOS database. Patients were stratified into two groups: old system and new system. We identified 872 patients who met inclusion criteria. Of these, 608 and 264 were classified in the old and new system groups, respectively. The time in the waitlist was shorter (25 vs. 54 days, P < .001), with an increased frequency of HT in the new system (74% vs. 68%, P = .024). Patients who were transplanted in the new system had a longer ischemic time, increased use of temporary mechanical circulatory support and mechanical ventilation. There was no difference in posttransplant survival at 9 months (91.1% vs. 88.9%) (p = .4). We conclude that patients with RCM/HCM have benefited from the new HT allocation system, with increased access to HT without affecting short-term posttransplant survival.