Characterizing Adaptive Changes and Patient Survival After 2018 Donor Allocation Restructuring: A UNOS Database Analysis.

PURPOSE: We sought to characterize adaptive changes to the revised United Network for Organ Sharing donor heart allocation policy and estimate long-term survival trends for heart transplant (HTx) recipients. METHODS: Patients listed for HTx between October 17, 2013 and September 30, 2021 were identified from the United Network for Organ Sharing database, and stratified into pre- and postpolicy revision groups. Subanalyses were performed to examine trends in device utilization for extracorporeal membranous oxygenation (ECMO), durable left ventricular assist device (LVAD), intra-aortic balloon pump (IABP), microaxial support (Impella), and no mechanical circulatory support (non-MCS). Survival data post-HTx were fitted to parametric distributions and extrapolated to 5 years. RESULTS: We identified 27,523 HTx waitlist candidates during the study period, most of whom (n = 16,376) were waitlisted in the prepolicy change period. Overall, 19,554 patients underwent HTx during the study period (pre: 12,037 and post: 7517). Listings increased after the policy change for ECMO ( P < 0.01), Impella ( P < 0.01), and IABP ( P < 0.01) patients. Listings for LVAD ( P < 0.01) and non-MCS ( P < 0.01) patients decreased. HTx increased for ECMO ( P < 0.01), Impella ( P < 0.01), and IABP ( P < 0.01) patients after the policy change and decreased for LVAD ( P < 0.01) and non-MCS ( P < 0.01) patients. Waitlist survival increased for the overall ( P < 0.01), ECMO ( P < 0.01), IABP ( P < 0.01), and non-MCS ( P < 0.01) groups. Waitlist survival did not differ for the LVAD ( P = 0.8) and Impella ( P = 0.1) groups. Post-transplant survival decreased for the overall ( P < 0.01), LVAD ( P < 0.01), and non-MCS ( P < 0.01) populations. CONCLUSIONS: Allocation policy revisions have contributed to greater utilization of ECMO, Impella, and IABP, decreased utilization of LVADs and non-MCS, increased waitlist survival, and decreased post-HTx survival.

Impact of Left Ventricular Unloading on Outcome of Heart Transplant Bridging With Extracorporeal Membrane Oxygenation Support in New Allocation Policy.

BACKGROUND: The new heart allocation policy places veno-arterial extracorporeal membrane oxygenation (VA-ECMO)-supported heart transplant (HT) candidates at the highest priority status. Despite increasing evidence supporting left ventricular (LV) unloading during VA-ECMO, the effect of LV unloading on transplant outcomes following bridging to HT with VA-ECMO remains unknown. METHODS AND RESULTS: From October 18, 2018 to March 21, 2023, 624 patients on VA-ECMO at the time of HT were identified in the United Network for Organ Sharing database and were divided into 2 groups: VA-ECMO alone (N=384) versus VA-ECMO with LV unloading (N=240). Subanalysis was performed in the LV unloading group: Impella (N=106) versus intra-aortic balloon pump (N=134). Recipient age was younger in the VA-ECMO alone group (48 versus 53 years, P=0.018), as was donor age (VA-ECMO alone, 29 years versus LV unloading, 32 years, P=0.041). One-year survival was comparable between groups (VA-ECMO alone, 88.0±1.8% versus LV unloading, 90.4±2.1%; P=0.92). Multivariable Cox hazard model showed LV unloading was not associated with posttransplant mortality after HT (hazard ratio, 0.92; P=0.70). Different LV unloading methods had similar 1-year survival (intra-aortic balloon pump, 89.2±3.0% versus Impella, 92.4±2.8%; P=0.65). Posttransplant survival was comparable between different Impella versions (Impella 2.5, versus Impella CP, versus Impella 5.0, versus Impella 5.5). CONCLUSIONS: Under the current allocation policy, LV unloading did not impact waitlist outcome and posttransplant survival in patients bridged to HT with VA-ECMO, nor did mode of LV unloading. This highlights the importance of a tailored approach in HT candidates on VA-ECMO, where routine LV unloading may not be universally necessary.

Impact of right ventricular dysfunction on outcomes in patients requiring intra-aortic balloon pump placement: A retrospective nationwide analysis (2016-2020).

Right ventricular dysfunction (RVD) continues to be a significant contributor to both mortality and morbidity, posing a significant challenge in the management of patients undergoing evaluation for mechanical circulatory support (MCS). Currently, there is a paucity of data regarding outcomes in this subset of patients. We analyzed the National Inpatient Sample database (NIS) to identify adult hospitalizations who underwent intra-aortic balloon pump (IABP) placement with or without co-existence of RVD. Multivariate logistic regression, and linear regression analyses were used to compare outcomes, and adjust for possible confounders. Out of 126,985 hospitalizations who underwent IABP placement, 1,475 (1.2%) had RVD. Patients with RVD who received an IABP had higher adjusted odds of inpatient mortality (Adjusted odds ratio [aOR]: 2.33, 95% confidence interval [CI]: 1.7-3.2, p<0.001) than those without co-existing RVD. Hospitalized patients who underwent IABP placement with RVD had higher adjusted odds of worse hospitalization outcomes in general. Conducting additional prospective studies and clinical trials with an emphasis on further subcategorization of patients with RVD is crucial for determining optimal management strategies for these patients.

Percutaneous Microaxial Ventricular Assist Device Versus Intra-Aortic Balloon Pump for Nonacute Myocardial Infarction Cardiogenic Shock.

BACKGROUND: Evidence on the comparative outcomes following percutaneous microaxial ventricular assist devices (pVAD) versus intra-aortic balloon pump for nonacute myocardial infarction cardiogenic shock is limited. METHODS AND RESULTS: We included 704 and 2140 Medicare fee-for-service beneficiaries aged 65 to 99 years treated with pVAD and intra-aortic balloon pump, respectively, for nonacute myocardial infarction cardiogenic shock from 2016 to 2020. Patients treated using pVAD compared with those treated using intra-aortic balloon pump were more likely to be concurrently treated with mechanical ventilation, renal replacement therapy, and blood transfusions. We computed propensity scores for undergoing pVAD using patient- and hospital-level factors and performed a matching weight analysis. The use of pVAD was associated with higher 30-day mortality (adjusted odds ratio, 1.92 [95% CI, 1.59-2.33]) but not associated with in-hospital bleeding (adjusted odds ratio, 1.00 [95% CI, 0.81-1.24]), stroke (adjusted odds ratio, 0.91 [95% CI, 0.56-1.47]), sepsis (OR, 0.91 [95% CI, 0.64-1.28]), and length of hospital stay (adjusted mean difference, +0.4 days [95% CI, -1.4 to +2.3]). A quasi-experimental instrumental variable analysis using the cross-sectional institutional practice preferences showed similar patterns, though not statistically significant (adjusted odds ratio, 1.38; 95% CI, 0.28-6.89). CONCLUSIONS: Our investigation using the national sample of Medicare beneficiaries showed that the use of pVAD compared with intra-aortic balloon pump was associated with higher mortality in patients with nonacute myocardial infarction cardiogenic shock. Providers should be cautious about the use of pVAD for nonacute myocardial infarction cardiogenic shock, while adequately powered high-quality randomized controlled trials are warranted to determine the clinical effects of pVAD.

Mechanical Circulatory Support in Cardiogenic Shock: Uses in the Emergency Setting.

Cardiogenic shock is a lethal condition with significant morbidity, characterized by myocardial insults leading to low cardiac output and ensuing systemic hypoperfusion. While mortality rates remain high, we have improved upon our recognition and definition of cardiogenic shock, now with an emphasis on defining stages of shock to help guide effective treatment strategies with either pharmacologic or mechanical circulatory support. In this review, the authors summarize these stages as well as discuss indications, function, selection, and troubleshooting of the various temporary mechanical circulatory support devices.

Early vs. delayed mechanical circulatory support in patients with acute myocardial infarction and cardiogenic shock.

AIMS: Despite increased temporary mechanical circulatory support (tMCS) utilization for acute myocardial infarction complicated by cardiogenic shock (AMI-CS), data regarding efficacy and optimal timing for tMCS support are limited. This study aimed to describe outcomes based on tMCS timing in AMI-CS and to identify predictors of 30-day mortality and readmission. METHODS AND RESULTS: Patients with AMI-CS identified in the National Readmissions Database were grouped according to the use of tMCS and early (<24 h) vs. delayed (≥24 h) tMCS. The correlation between tMCS timing and inpatient outcomes was evaluated using linear regression. Multivariate logistic regression was used to identify variables associated with 30-day mortality and readmission. Of 294 839 patients with AMI-CS, 109 148 patients were supported with tMCS (8067 veno-arterial extracorporeal membrane oxygenation, 33 577 Impella, and 79 161 intra-aortic balloon pump). Of patients requiring tMCS, patients who received early tMCS (n = 79 906) had shorter lengths of stay (7 vs. 15 days, P < 0.001) and lower rates of ischaemic and bleeding complications than those with delayed tMCS (n = 32 241). Patients requiring tMCS had higher in-hospital mortality [odds ratio (95% confidence interval)] [1.7 (1.7-1.8), P < 0.001]. Among patients requiring tMCS, early support was associated with fewer complications, lower mortality [0.90 (0.85-0.94), P < 0.001], and fewer 30-day readmissions [0.91 (0.85-0.97), P = 0.005] compared with patients with delayed tMCS. CONCLUSION: Among patients receiving tMCS for AMI-CS, early tMCS was associated with fewer complications, shorter lengths of stay, lower hospital costs, and fewer deaths and readmissions at 30 days.

The Effects of Exercise on Cardiogenic Shock with an Intra-Aortic Balloon Pump: A Case Report. / Efeitos do Exercício em Choque Cardiogênico e Balão Intra-Aórtico: Um Relato de Caso.

This case report describes the exercise program on a hospitalized 54-year-old male patient with cardiogenic shock waiting for a heart transplant assisted by an intra-aortic balloon pump, a temporary mechanical circulatory support device. The temporary mechanical circulatory support device, an intra-aortic balloon pump, was placed in the left subclavian artery, enabling the exercise protocol. Measurements and values from Swan-Ganz catheter, blood sample, brain natriuretic peptide (NT-proBNP), and high-sensitivity C-reactive protein (hs-CRP), as well as the six-minute walk test (6MWT) and venous oxygen saturation (SvO2) were obtained before and after an exercise protocol. The exercise training protocol involved the use of an unloaded bed cycle ergometer once a day, for a maximum of 30 minutes, to the tolerance limit. No adverse events or events related to the dislocation of the intra-aortic balloon pump were observed during the exercise protocol. The exercise program resulted in higher SvO2 levels, with an increased 6MWT with lower Borg dyspnea scores (312 meters vs. 488 meters and five points vs. three points, respectively). After completing the ten-day exercise protocol, the patient underwent a non-complicated heart transplant surgery and a full recovery in the ICU. This study showed that exercise is a feasible option for patients with cardiogenic shock who are using an intra-aortic balloon pump and that it is well-tolerated with no reported adverse events.

O presente relato de caso descreve o programa de exercícios aplicado a um paciente do sexo masculino, de 54 anos, internado com choque cardiogênico, aguardando transplante cardíaco e assistido por balão intra-aórtico, um dispositivo de suporte circulatório mecânico temporário. O dispositivo de suporte circulatório mecânico temporário, um balão intra-aórtico, foi colocado na artéria subclávia esquerda, possibilitando o protocolo de exercícios. Antes e após um protocolo de exercícios, foram obtidos dados a partir de cateter de Swan-Ganz, amostra de sangue, peptídeo natriurético cerebral (NT-proBNP), proteína C reativa de alta sensibilidade (PCR-as), teste de caminhada de seis minutos (TC6min) e medição da saturação venosa de oxigênio (SvO2). O protocolo de treinamento físico envolveu a utilização de um cicloergômetro adaptado ao leito, sem carga, uma vez ao dia, por no máximo 30 minutos, até o limite da tolerância. Não foram observados eventos adversos tampouco relacionados ao deslocamento do balão intra-aórtico durante o protocolo de exercícios. O programa de exercícios resultou em maior SvO2 com aumento do TC6min e menores escores de dispneia de Borg (312 metros vs. 488 metros e cinco pontos vs. três pontos, respectivamente). Após completar o protocolo de exercícios de dez dias, o paciente foi submetido a uma cirurgia de transplante cardíaco sem complicações e recuperação total na UTI. O presente estudo demonstrou que o exercício é uma opção viável para pacientes com choque cardiogênico em uso de balão intra-aórtico e que é bem tolerado, além de não haver relatos de eventos adversos.

Mechanical Circulatory Support During Surgical Revascularization for Ischemic Cardiomyopathy.

BACKGROUND: This study aimed to describe the use of perioperative mechanical circulatory support (MCS) and its impact on outcomes in patients with ischemic cardiomyopathy who were undergoing surgical revascularization. METHODS: Patients with an ejection fraction <35% who underwent isolated coronary artery bypass grafting (CABG) from 2015 to 2021 were identified (N = 378). Patients were divided into no MCS, preoperative MCS, and postoperative MCS groups on the basis of timing of MCS initiation, which included intraaortic balloon pump, extracorporeal membrane oxygenation, or Impella device (Abiomed) use. The primary outcome of interest was operative mortality. RESULTS: The median Society of Thoracic Surgeons Predicted Risk of Mortality was 2.4%. Sixty-six percent (n = 246) of patients had a previous myocardial infarction, and 61.8% of these patients were within 21 days of CABG. Twenty-one patients (5.6%) presented in cardiogenic shock. The preoperative MCS cohort consisted of 31 patients (8.2%) who underwent CABG a median of 2 days after MCS initiation. Thirty (7.9%) patients required postoperative MCS. Independent risk factors for requiring postoperative MCS included the preoperative ejection fraction (odds ratio, 0.93; P = .01 and the presence of preoperative MCS (odds ratio, 3.06; P = .02). Overall, operative mortality was 3.4%, and 3-year survival was 87.0%. Operative mortality in patients who did and did not receive preoperative MCS was 7.7% and 2.9% (P = .12) with no difference in long-term survival (P = .80), whereas patients requiring postoperative MCS had significantly increased operative (16.7%) and late mortality (63%; P <.01). CONCLUSIONS: CABG can be performed safely in patients with ischemic cardiomyopathy with selective use of perioperative MCS. Despite advanced disease severity, patients requiring preoperative MCS demonstrate acceptable short- and long-term survival. Patients requiring postoperative MCS have increased postoperative morbidity and mortality.

Mechanical Circulatory Support for High-Risk Percutaneous Coronary Intervention.

PURPOSE OF REVIEW: This review will focus on the indications of mechanical circulatory support (MCS) for high-risk percutaneous coronary intervention (PCI) and then analyze in detail all MCS devices available to the operator, evaluating their mechanisms of action, pros and cons, contraindications, and clinical data supporting their use. RECENT FINDINGS: Over the last decade, the interventional cardiology arena has witnessed an increase in the complexity profile of the patients and lesions treated in the catheterization laboratory. Patients with significant comorbidity burden, left ventricular dysfunction, impaired hemodynamics, and/or complex coronary anatomy often cannot tolerate extensive percutaneous revascularization. Therefore, a variety of MCS devices have been developed and adopted for high-risk PCI. Despite the variety of MCS available to date, a detailed characterization of the patient requiring MCS is still lacking. A precise selection of patients who can benefit from MCS support during high-risk PCI and the choice of the most appropriate MCS device in each case are imperative to provide extensive revascularization and improve patient outcomes. Several new devices are being tested in early feasibility studies and randomized clinical trials and the experience gained in this context will allow us to provide precise answers to these questions in the coming years.

Impact of Age, Gender, and Body Mass Index on Short-Term Outcomes of Patients With Cardiogenic Shock on Mechanical Circulatory Support.

This single-center, observational study assessed the impact of age, gender, and body mass index (BMI) in patients with cardiogenic shock (CS) on temporary mechanical circulatory support. All adult patients admitted to the Cleveland Clinic main campus Cardiac Intensive Care Unit (CICU) between December 1, 2015, to December 31, 2019, CICU with CS necessitating mechanical circulatory support (MCS) with intra-aortic balloon pump, Impella, or venous arterial-extra corporeal membrane oxygenation were retrospectively analyzed for this study. Baseline characteristics and 30-day outcomes were collected through physician-directed chart review. The impact of age, gender, and BMI on 30-day mortality was assessed using multivariable logistic regression. Kaplan-Meier survival curves were used to analyze the survival difference in specific subsets. A total of 393 patients with CS on temporary MCS were admitted to our CICU during the study period. The median age of our cohort was 63 years (interquartile range 54 to 70 years), median BMI was 28.50 kg/m2 (interquartile range 24.62 to 29.72) and 70% (n = 276) were men. In total, 22 patients >80 years had received MCS compared with 372 patients <80 years. Patients >80 years on MCS had significantly higher 30-day mortality compared with those <80 years (81.8% vs 49.3%, p = 0.006). Upon stratifying patients by BMI, 161 (41%) patients were found to have BMI ≥30 kg/m2 whereas 232 (59%) patients had BMI <30 kg/m2. Comparison of 30-day mortality revealed that patients with BMI ≥30 did significantly worse than patients with BMI <30 (59.6% vs 45.3%, p = 0.007). There was no difference in 30-day mortality between men and women. On multivariable logistic regression, both age and BMI had a positive linear relation with adjusted 30-day mortality whereas gender did not have a major effect. Advanced age and higher BMI are independently associated with worse outcomes in patients with CS on MCS. Utilizing a strict selection criterion for patients in CS is pertinent to derive the maximum benefit from advanced mechanical support.

Blood perfusion status is important in the prognosis of ventricular aneurysm complicated by ventricular septal rupture.

AIMS: Due to its low incidence, poor prognosis, and high mortality in the acute phase, the long-term prognosis of the left ventricular aneurysm (LVA) complicated by ventricular septal rupture (VSR) has received little attention. This study focus on the long-term prognosis of patients with LVA complicated by relatively stable VSR. METHODS AND RESULTS: Over a decade of retrospection, 68 patients with both LVA and VSR were compared with 136 patients with LVA alone after propensity score matching. Patients with both LVA and VSR were further divided into two groups depending on whether pre-operative intra-aortic balloon pump (IABP) was used (23 pre-operative IABP vs. 45 non-pre-operative IABP). The primary endpoint was defined as major adverse cardiovascular and cerebrovascular events, a composite endpoint including mortality, myocardial infarction, revascularization, stroke, and heart failure. Patients with both LVA and VSR were generally in a worse condition upon admission compared with those with LVA alone [percentage of patients in New York Heart Association IV: 42.6% (29/68) vs. 11.0% (15/136), P < 0.001]. Both pre-operative and post-operative IABP use rates were significantly higher in patients with both LVA and VSR than in patients with LVA alone [pre-operative IABP use rates: 33.8% (23/68) vs. 0.74% (1/136), P < 0.001 and post-operative IABP use rates: 33.8% (23/68) vs. 10.3% (14/136), P < 0.001]. No significant difference was observed in the primary endpoint between patients with both LVA and VSR and those with LVA alone (log-rank test, P = 0.63, median follow-up time 63 months). We further investigated the effect of pre-operative IABP on the long-term prognosis of patients with both LVA and VSR. Patients who applied pre-operative IABP had a worse long-term prognosis than those who did not (log-rank test, P = 0.0011). CONCLUSIONS: The long-term prognosis of LVA combined with VSR was not inferior than LVA alone after surgery, but poor blood perfusion status was associated with a worse prognosis.

Outcomes in Heart Transplant Recipients by Bridge to Transplant Strategy When Using the SherpaPak Cardiac Transport System.

The last several years have seen a rise in use of mechanical circulatory support (MCS) to bridge heart transplant recipients. A controlled hypothermic organ preservation system, the SherpaPak Cardiac Transport System (SCTS), was introduced in 2018 and has grown in utilization with reports of improved posttransplant outcomes. The Global Utilization And Registry Database for Improved heArt preservatioN (GUARDIAN)-Heart registry is an international, multicenter registry assessing outcomes after transplant using the SCTS. This analysis examines outcomes in recipients bridged with various MCS devices in the GUARDIAN-Heart Registry. A total of 422 recipients with donor hearts transported using SCTS were included and identified. Durable ventricular assist devices (VADs) were used exclusively in 179 recipients, temporary VADs or intra-aortic balloon pump (IABP) in 197, and extracorporeal membrane oxygenation (ECMO) in 14 recipients. Average ischemic times were over 3.5 hours in all cohorts. Severe primary graft dysfunction (PGD) posttransplant increased across groups (4.5% VAD, 5.1% temporary support, 21.4% ECMO), whereas intensive care unit (ICU) length of stay (18.2 days) and total hospital stay (39.4 days) was longer in the ECMO cohort than the VAD and IABP groups. A comparison of outcomes of MCS bridging in SCTS versus traditional ice revealed significantly lower rates of both moderate/severe right ventricular (RV) dysfunction and severe PGD in the SCTS cohort; however, upon propensity matching only the reductions in moderate/severe RV dysfunction were statistically significant. Use of SCTS in transplant recipients with various bridging strategies results in excellent outcomes.