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.

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.

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.

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.

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.

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.

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.

Intra-aortic balloon pump is associated with the lowest whereas Impella with the highest inpatient mortality and complications regardless of severity or hospital types.

Impella and intra-aortic balloon pumps (IABP) are commonly utilized in patients with cardiogenic shock. However, the effect on mortality remains controversial. The goal of this study was to evaluate the effect of Impella and IABP on mortality in patients with cardiogenic shock the large Nationwide Inpatient Sample (NIS) database was utilized to study any association between the use of IABP or Impella on outcome. ICD-10 codes for Impella, IABP, and cardiogenic shock for available years 2016-2020 were utilized. A total of 844,020 patients had a diagnosis of cardiogenic shock. A total of 101,870 patients were treated with IABP and 39645 with an Impella. Total inpatient mortality without any device was 34.2% vs only 25.1% with IABP use (OR = 0.65, CI 0.62-0.67) but was highest at 40.7% with Impella utilization (OR = 1.32, CI 1.26-1.39). After adjusting for 47 variables, Impella utilization remained associated with the highest mortality (OR: 1.33, CI 1.25-1.41, p < 0.001), whereas IABP remained associated with the lowest mortality (OR: 0.69, CI 0.66-0.72, p < 0.001). Separating rural vs teaching hospitals revealed similar findings. In patients with cardiogenic shock, the use of Impella was associated with the highest whereas IABP was associated with the lowest in-hospital mortality regardless of comorbid condition.

US trends of in-hospital morbidity and mortality for acute myocardial infarctions complicated by cardiogenic shock.

BACKGROUND: There is limited real-world data highlighting recent temporal in-hospital morbidity and mortality trends for cases of acute myocardial infarction complicated by cardiogenic shock. The role of mechanical circulatory support within this patient population remains unclear. METHODS: The US National Inpatient Sample database was sampled from 2011 to 2018 identifying 206,396 hospitalizations with a primary admission diagnosis of ST- or Non-ST elevation myocardial infarction complicated by cardiogenic shock. The primary outcomes included trends of all-cause in-hospital mortality, mechanical circulatory support use, and sex-specific trends for acute myocardial infarction complicated by cardiogenic shock (AMI-CS) over the study period. RESULTS: The annual number of AMI-CS hospitalizations increased from 22,851 in 2011 to 30,015 in 2018 and in-hospital mortality trends remained similar (42.9 % to 43.7 %, ptrend < 0.001). The proportion of patients receiving any temporary MCS device decreased (46.4 % to 44.4 %). The use of intra-aortic balloon pump (IABP) decreased (44.9 % to 32.9 %) and the use of any other non-IABP MCS device increased (2.5 % to 15.6 %), ptrend<0.001. Sex-specific mortality indicate female in-hospital mortality remained similar (50.3 % to 51 %, ptrend<0.001), but higher than male in-hospital mortality, which increased non-significantly (38.8 % to 40.2 %, ptrend = 0.372). CONCLUSIONS: From 2011 to 2018, hospitalizations for AMI-CS patients have increased in number. However, there has been no recent appreciable change in AMI-CS mortality despite a changing treatment landscape with decreasing use of IABPs and increasing use of non-IABP MCS devices. Further research is necessary to examine the appropriate use of MCS devices within this population.

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.

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.

Microaxial mechanical circulatory support after orthotopic heart transplantation.

AIM: Use of microaxial mechanical circulatory support (MCS) has been reported for severe graft rejection or dysfunction after heart transplantation (HTx). We aimed to assess utilization patterns of microaxial MCS after HTx in adolescents (ages 18 and younger) and adults (ages 19 and older). METHODS: Electronic search was performed to identify all relevant studies on post-HTx use of microaxial support in adults and adolescents. A total of 18 studies were selected and patient-level data were extracted for statistical analysis. RESULTS: All patients (n=23), including adults (n=15) and adolescents (n=8), underwent Impella (Abiomed, Danvers, MA) microaxial MCS after HTx. Median age was 36 [IQR 18-56] years (Adults, 52 [37-59]; adolescents, 16 [15-17]). Primary right ventricular graft dysfunction was an indication exclusively seen in the adults 40% (6/15), while acute graft rejection was present in 46.7% (7/15) of adults. Median time after transplant was 9 [0-32] months (Adults, 4 [0-32]; adolescents, 11 [4.5, 45]). Duration of Impella support was comparable between adults and adolescents (5 [2.5-8] vs 6 [5-8] days, p = 0.38). Overall improvement was observed both in median LV ejection fraction (23.5% [11.3-28] to 42% [37.8-47.3], p < 0.01) and cardiac index (1.8 [1.2-2.6] to 3 [2.5-3.1], p < 0.01). Retransplantation was required in four adolescents (50%, 4/8). Survival to discharge was achieved by 60.0% (9/15) of adults and 87.5% (7/8) of adolescents respectively (p = 0.37). CONCLUSION: Indications for microaxial MCS appear to vary between adult and adolescent patients. Overall improvement in LVEF and cardiac index was observed, however, with suboptimal survival to discharge.

Single arterial access technique for simultaneous dual mechanical circulatory support in cardiogenic shock.

Temporary mechanical circulatory support is a treatment of choice for patients in severe cardiogenic shock. Combining veno-arterial extracorporeal life support (ECLS) with devices that enable left ventricular unloading emerges as a promising strategy to diminish detrimental effect of elevated left ventricular afterload and to improve survival. However, the need to establish multiple arterial access sites remains a major drawback of this approach due to a significant rate of vascular complications. We describe herein a case of a single arterial access for ECLS and intra-aortic balloon pump using axillary artery that may provide a simple, modular and flexible approach for escalation or de-escalation of mechanical circulatory support.