Prognostic Implications of Quantifying Vasoactive Medications in Cardiogenic Shock.

None.

Factors associated with Acute Limb Ischemia in Cardiogenic Shock and downstream Clinical Outcomes: Insights from the Cardiogenic Shock Working Group.

BACKGROUND: There are limited data depicting the prevalence and ramifications of acute limb ischemia (ALI) among cardiogenic shock (CS) patients. METHODS: We employed data from the Cardiogenic Shock Working Group (CSWG), a consortium including 33 sites. We constructed a multi-variable logistic regression to examine the association between clinical factors and ALI, we generated another logistic regression model to ascertain the association of ALI with mortality. RESULTS: There were 7,070 patients with CS and 399 (5.6%) developed ALI. Patients with ALI were more likely to be female (40.4% versus 29.4%) and have peripheral arterial disease (13.8% versus 8.3%). Stratified by maximum SCAI shock stage, the rates of ALI were stage B 0.0%, stage C 1.8%, stage D 4.1%, and stage E 10.3%. Factors associated with higher risk for ALI included: peripheral vascular disease OR 2.24 (95% CI: 1.53 - 3.23; p < 0.01) and ≥ 2 mechanical circulatory support (MCS) devices OR 1.66 (95% CI: 1.24 - 2.21, p < 0.01). ALI was highest for VA-ECMO patients (11.6%) or VA-ECMO + IABP/Impella CP (16.6%) yet use of distal perfusion catheters was less than 50%. Mortality was 38.0% for CS patients without ALI but 57.4% for CS patients with ALI. ALI was significantly associated with mortality, adjusted OR 1.40 (95% CI 1.01 - 1.95, p < 0.01). CONCLUSIONS: The rate of ALI was 6% among CS patients. Factors most associated with ALI include peripheral vascular disease and multiple MCS devices. The downstream ramifications of ALI were dire with a considerably higher risk of mortality.

Transradial stenting of left subclavian artery origin using shockwave intravascular lithotripsy balloon plasty: Technical report and literature review.

Lesions of the subclavian artery often involve pathologic stenosis due to high degrees of calcification within the vessel wall. While endovascular angioplasty and stenting is generally the preferred method for obtaining flow reconstitution, calcification of the vessel wall has proven to significantly impair the efficacy of successful stent deployment. Shockwave intravascular lithotripsy (IVL) is a technology that has been very successful in addressing this challenge in other vascular territories, however its use has yet to be approved for supra-aortic vessels such as the subclavian artery. In this report, the use of IVL for a case of subclavian steal syndrome due to a highly stenosed left subclavian artery is described along with a review of the literature. Although several cases utilizing this technology in subclavian arteries have been reported, none have described the use of a left transradial approach. Therefore the purpose of this report is to demonstrate the efficacy of IVL for supra-aortic vessels so that its benefits can be expanded to a broader patient population.

Delaying reperfusion plus left ventricular unloading reduces infarct size: Sub-analysis of DTU-STEMI pilot study.

INTRODUCTION: The STEMI-DTU pilot study tested the early safety and practical feasibility of left ventricular (LV) unloading with a trans-valvular pump before reperfusion. In the intent-to-treat cohort, no difference was observed for microvascular obstruction (MVO) or infarct size (IS) normalized to either the area at risk (AAR) at 3-5 days or total LV mass (TLVM) at 3-5 days We now report a per protocol analysis of the STEMI-DTU pilot study. METHODS: In STEMI-DTU STUDY 50 adult patients (25 in each arm) with anterior STEMI [sum of precordial ST-segment elevation (ΣSTE) ≥4 mm] requiring primary percutaneous coronary intervention (PCI) were enrolled. Only patients who met all inclusion and exclusion criteria were included in this analysis. Cardiac magnetic resonance (CMR) imaging 3-5 days after PCI quantified IS/AAR and IS/TLVM and MVO. Group differences were assessed using Student's t-tests and linear regression (SAS Version-9.4). RESULTS: Of the 50 patients enrolled, 2 died before CMR imaging. Of the remaining 48 patients those without CMR at 3-5 days (n = 8), without PCI of a culprit left anterior descending artery lesion (n = 2), with OHCA (n = 1) and with ΣSTE < 4 mm (n = 5) were removed from this analysis leaving 32/50 (64 %) patients meeting all inclusion and exclusion criteria (U-IR, n = 15; U-DR, n = 17) as per protocol. Despite longer symptom-to-balloon times in the U-DR arm (228 ± 80 vs 174 ± 59 min, p < 0.01), IS/AAR was significantly lower with 30 min of delay to reperfusion in the presence of active LV unloading (47 ± 16 % vs 60 ± 15 %, p = 0.02) and remained lower irrespective of the magnitude of precordial ΣSTE. MVO was not significantly different between groups (1.5 ± 2.8 % vs 3.5 ± 4.8 %, p = 0.15). Among patients who received LV unloading within 180 min of symptom onset, IS/AAR was significantly lower in the U-DR group. CONCLUSION: In this per-protocol analysis of the STEMI-DTU pilot study we observed that LV unloading for 30 min before reperfusion significantly reduced IS/AAR compared to LV unloading and immediate reperfusion, whereas in the ITT cohort no difference was observed between groups. This observation supports the design of the STEMI-DTU pivotal trial and suggests that strict adherence to the study protocol can significantly influence the outcome.

Impact of Female Sex on Cardiogenic Shock Outcomes: A Cardiogenic Shock Working Group Report.

BACKGROUND: Studies reporting cardiogenic shock (CS) outcomes in women are scarce. OBJECTIVES: The authors compared survival at discharge among women vs men with CS complicating acute myocardial infarction (AMI-CS) and heart failure (HF-CS). METHODS: The authors analyzed 5,083 CS patients in the Cardiogenic Shock Working Group. Propensity score matching (PSM) was performed with the use of baseline characteristics. Logistic regression was performed for log odds of survival. RESULTS: Among 5,083 patients, 1,522 were women (30%), whose mean age was 61.8 ± 15.8 years. There were 30% women and 29.1% men with AMI-CS (P = 0.03). More women presented with de novo HF-CS compared with men (26.2% vs 19.3%; P < 0.001). Before PSM, differences in baseline characteristics and sex-specific outcomes were seen in the HF-CS cohort, with worse survival at discharge (69.9% vs 74.4%; P = 0.009) and a higher rate of maximum Society for Cardiac Angiography and Interventions stage E (26% vs 21%; P = 0.04) in women than in men. Women were less likely to receive pulmonary artery catheterization (52.9% vs 54.6%; P < 0.001), heart transplantation (6.5% vs 10.3%; P < 0.001), or left ventricular assist device implantation (7.8% vs 10%; P = 0.01). Regardless of CS etiology, women had more vascular complications (8.8% vs 5.7%; P < 0.001), bleeding (7.1% vs 5.2%; P = 0.01), and limb ischemia (6.8% vs 4.5%; P = 0.001). More vascular complications persisted in women after PSM (10.4% women vs 7.4% men; P = 0.06). CONCLUSIONS: Women with HF-CS had worse outcomes and more vascular complications than men with HF-CS. More studies are needed to identify barriers to advanced therapies, decrease complications, and improve outcomes of women with CS.

Standardized Definitions for Cardiogenic Shock Research and Mechanical Circulatory Support Devices: Scientific Expert Panel From the Shock Academic Research Consortium (SHARC).

The Shock Academic Research Consortium is a multi-stakeholder group, including representatives from the US Food and Drug Administration and other government agencies, industry, and payers, convened to develop pragmatic consensus definitions useful for the evaluation of clinical trials enrolling patients with cardiogenic shock, including trials evaluating mechanical circulatory support devices. Several in-person and virtual meetings were convened between 2020 and 2022 to discuss the need for developing the standardized definitions required for evaluation of mechanical circulatory support devices in clinical trials for cardiogenic shock patients. The expert panel identified key concepts and topics by performing literature reviews, including previous clinical trials, while recognizing current challenges and the need to advance evidence-based practice and statistical analysis to support future clinical trials. For each category, a lead (primary) author was assigned to perform a literature search and draft a proposed definition, which was presented to the subgroup. These definitions were further modified after feedback from the expert panel meetings until a consensus was reached. This manuscript summarizes the expert panel recommendations focused on outcome definitions, including efficacy and safety.

Extracorporeal cardiopulmonary resuscitation for out-of-hospital cardiac arrest: A meta-analysis of randomized controlled trials.

INTRODUCTION: Extracorporeal cardiopulmonary resuscitation (ECPR) is a resuscitation method for patients with refractory out-of-hospital cardiac arrest (OHCA). However, evidence from randomized controlled trials (RCTs) is lacking. METHODS: We searched several electronic databases until March 2023 for RCTs comparing ECPR with conventional CPR in OHCA patients. RevMan 5.4 was used to pool risk ratios (RR) with 95% confidence intervals (CIs). RESULTS: A total of four RCTs were included. The results of our meta-analysis showed no statistically significant benefit of ECPR regarding mid-term survival (RR 1.21; 95% CI 0.64 to 2.28; I2 = 48%; p = .55). We found a significant improvement with ECPR in mid-term favorable neurological outcome (RR 1.59; 95% CI 1.09 to 2.33; I2 = 0%; p = .02). There was no significant difference between ECPR and conventional CPR in long-term survival (RR 1.32; 95% CI 0.18 to 9.50; I2 = 64%; p = .79), and long-term favorable neurological outcome (RR 1.47; 95% CI 0.89 to 2.43; I2 = 25%; p = .13). There was an increased incidence of adverse events in the ECPR group (RR 3.22; 95% CI 1.18 to 8.80; I2 = 63%; p = .02). CONCLUSION: ECPR in OHCA patients was not associated with improved survival or long-term favorable neurological outcome but did improve favorable neurological outcome in the mid-term. However, these results are likely underpowered due to the small number of available RCTs. Large-scale confirmatory RCTs are needed to provide definitive conclusions.

Pulmonary Artery Catheter Use and Risk of In-hospital Death in Heart Failure Cardiogenic Shock.

BACKGROUND: Pulmonary artery catheters (PACs) are increasingly used to guide management decisions in cardiogenic shock (CS). The goal of this study was to determine if PAC use was associated with a lower risk of in-hospital mortality in CS owing to acute heart failure (HF-CS). METHODS AND RESULTS: This multicenter, retrospective, observational study included patients with CS hospitalized between 2019 and 2021 at 15 US hospitals participating in the Cardiogenic Shock Working Group registry. The primary end point was in-hospital mortality. Inverse probability of treatment-weighted logistic regression models were used to estimate odds ratios (ORs) and corresponding 95% confidence intervals (CI), accounting for multiple variables at admission. The association between the timing of PAC placement and in-hospital death was also analyzed. A total of 1055 patients with HF-CS were included, of whom 834 (79%) received a PAC during their hospitalization. In-hospital mortality risk for the cohort was 24.7% (n = 261). PAC use was associated with lower adjusted in-hospital mortality risk (22.2% vs 29.8%, OR 0.68, 95% CI 0.50-0.94). Similar associations were found across SCAI stages of shock, both at admission and at maximum SCAI stage during hospitalization. Early PAC use (≤6 hours of admission) was observed in 220 PAC recipients (26%) and associated with a lower adjusted risk of in-hospital mortality compared with delayed (≥48 hours) or no PAC use (17.3% vs 27.7%, OR 0.54, 95% CI 0.37-0.81). CONCLUSIONS: This observational study supports PAC use, because it was associated with decreased in-hospital mortality in HF-CS, especially if performed within 6 hours of hospital admission. CONDENSED ABSTRACT: An observational study from the Cardiogenic Shock Working Group registry of 1055 patients with HF-CS showed that pulmonary artery catheter (PAC) use was associated with a lower adjusted in-hospital mortality risk (22.2% vs 29.8%, odds ratio 0.68, 95% confidence interval 0.50-0.94) compared with outcomes in patients managed without PAC. Early PAC use (≤6 hours of admission) was associated with a lower adjusted risk of in-hospital mortality compared with delayed (≥48 hours) or no PAC use (17.3% vs 27.7%, odds ratio 0.54, 95% confidence interval 0.37-0.81).

Review of Pathophysiology of Cardiogenic Shock and Escalation of Mechanical Circulatory Support Devices.

PURPOSE OF REVIEW: Cardiogenic shock (CS) is a complex clinical entity that continues to carry a high risk of mortality. The landscape of CS management has changed with the advent of several temporary mechanical circulatory support (MCS) devices designed to provide hemodynamic support. It remains challenging to understand the role of different temporary MCS devices in patients with CS, as many of these patients are critically ill, requiring complex care with multiple MCS device options. Each temporary MCS device can provide different types and levels of hemodynamic support. It is important to understand the risk/benefit profile of each one of them for appropriate device selection in patients with CS. RECENT FINDINGS: MCS may be beneficial in CS patients through augmentation of cardiac output with subsequent improvement of systemic perfusion. Selecting the optimal MCS device depends on several variables including the underlying etiology of CS, clinical strategy of MCS use (bridge to recovery, bridge to transplant or durable MCS, or abridge to decision), amount of hemodynamic support needed, associated respiratory failure, and institutional preference. Furthermore, it is even more challenging to determine the appropriate time to escalate from one MCS device to another or combine different MCS devices. In this review, we discuss the current available data published in the literature on the management of CS and propose a standardized approach for escalation of MCS devices in patients with CS. Shock teams can play an important role to help in hemodynamic-guided management and algorithm-based step-by-step approach in early initiation and escalation of temporary MCS devices at different stages of CS. It is important to define the etiology of CS, and stage of shock and recognize univentricular vs biventricular shock for appropriate device selection and escalation of therapy.

Clinical Presentation and In-Hospital Trajectory of Heart Failure and Cardiogenic Shock.

BACKGROUND: Heart failure-related cardiogenic shock (HF-CS) remains an understudied distinct clinical entity. OBJECTIVES: The authors sought to profile a large cohort of patients with HF-CS focused on practical application of the SCAI (Society for Cardiovascular Angiography and Interventions) staging system to define baseline and maximal shock severity, in-hospital management with acute mechanical circulatory support (AMCS), and clinical outcomes. METHODS: The Cardiogenic Shock Working Group registry includes patients with CS, regardless of etiology, from 17 clinical sites enrolled between 2016 and 2020. Patients with HF-CS (non-acute myocardial infarction) were analyzed and classified based on clinical presentation, outcomes at discharge, and shock severity defined by SCAI stages. RESULTS: A total of 1,767 patients with HF-CS were included, of whom 349 (19.8%) had de novo HF-CS (DNHF-CS). Patients were more likely to present in SCAI stage C or D and achieve maximum SCAI stage D. Patients with DNHF-CS were more likely to experience in-hospital death and in- and out-of-hospital cardiac arrest, and they escalated more rapidly to a maximum achieved SCAI stage, compared to patients with acute-on-chronic HF-CS. In-hospital cardiac arrest was associated with greater in-hospital death regardless of clinical presentation (de novo: 63% vs 21%; acute-on-chronic HF-CS: 65% vs 17%; both P < 0.001). Forty-five percent of HF-CS patients were exposed to at least 1 AMCS device throughout hospitalization. CONCLUSIONS: In a large contemporary HF-CS cohort, we identified a greater incidence of in-hospital death and cardiac arrest as well as a more rapid escalation to maximum SCAI stage severity among DNHF-CS. AMCS use in HF-CS was common, with significant heterogeneity among device types. (Cardiogenic Shock Working Group Registry [CSWG]; NCT04682483).

Treatment Intensity for the Management of Cardiogenic Shock: Comparison Between STEMI and Non-STEMI.

Background: Cardiogenic shock is a leading cause of mortality in patients with acute myocardial infarction. Objectives: The authors sought to compare clinical characteristics, hospital trajectory, and drug and device use between patients with ST-segment elevation myocardial infarction-related cardiogenic shock (STEMI-CS) and those without (non-ST-segment elevation myocardial infarction complicated by cardiogenic shock [NSTEMI-CS]). Methods: We analyzed data from 1,110 adult admissions with cardiogenic shock complicating acute myocardial infarction (AMI-CS) across 17 centers within Cardiogenic Shock Working Group. The primary end point was in-hospital mortality. Results: Our study included 1,110 patients with AMI-CS, of which 731 (65.8%) had STEMI-CS and 379 (34.2%) had NSTEMI-CS. Most patients were male (STEMI-CS: 71.6%, NSTEMI-CS: 66.5%) and White (STEMI-CS: 53.8%, NSTEMI-CS: 64.1%). In-hospital mortality was 41% and was similar among patients with STEMI-CS and NSTEMI-CS (43% vs 39%, P = 0.23). Patients with out-of-hospital cardiac arrest had higher in-hospital mortality in patients with NSTEMI-CS (63% vs 36%, P = 0.006) as compared to patients with STEMI-CS (52% vs 41%, P = 0.16). Similar results were observed for in-hospital cardiac arrest in patients with STEMI-CS (63% vs 33%, P < 0.001) and NSTEMI-CS (60% vs 32%, P < 0.001). Only 27% of patients with STEMI-CS and 12% of NSTEMI-CS received both a drug and temporary mechanical circulatory support device during the first 24 hours, which increased to 78% and 61%, respectively, throughout the course of the hospitalization (P < 0.001 for both). Conclusions: Despite increasing use of inotropic and vasoactive support and mechanical circulatory support throughout the hospitalization, both patients with STEMI-CS and NSTEMI-CS remain at increased risk for in-hospital mortality. Randomized controls trials are needed to elucidate whether timing and sequence of escalation of support improves outcomes in patients with AMI-CS.

Randomized Trials of Percutaneous Microaxial Flow Pump Devices: JACC State-of-the-Art Review.

The use of mechanical circulatory support devices in cardiovascular practice has risen exponentially over the past decade. These devices are currently used for hemodynamic support in patients with cardiogenic shock, high-risk percutaneous coronary intervention, left ventricular unloading, protection of kidneys, and right ventricular failure. The Impella (Abiomed) percutaneous microaxial flow pump devices are rapidly gaining popularity. However, despite their increasing use, there are limited randomized clinical trials (RCTs) to support the benefits of the therapy and growing concern regarding complication rates. Vascular problems, including bleeding and acute limb ischemia, are associated with the devices, but published reports also highlight risks for cardiac perforations, mitral chordae rupture, and stroke. In this review, we summarize the history, mechanism of action, previously published RCT data, and upcoming RCTs on these devices.

Association of HIV infection with clinical features and outcomes of patients with aortic aneurysms.

Data on the characteristics and outcomes of hospitalized patients with aortic aneurysms (AA) and HIV remain scarce. This is a cohort study of hospitalized adult patients with a diagnosis of AA from 2013 to 2019 using the US National Inpatient Readmission Database. Patients with a diagnosis of HIV were identified. Our outcomes included trends in hospitalizations and comparison of clinical characteristics, complications, and mortality in patients with AA and HIV compared to those without HIV. Among 1,905,837 hospitalized patients with AA, 4416 (0.23%) were living with HIV. There was an overall age-adjusted increase in the rate of HIV among patients hospitalized with AA over the years (14-29 per 10,000 person-years; age-adjusted p-trend < 0.001). Patients with AA and HIV were younger than those without HIV (median age: 60 vs 76 years, p < 0.001) and were less likely to have a history of smoking, hypertension, dyslipidemia, diabetes mellitus, and obesity. Thoracic aortic aneurysms were more prevalent in those with HIV (37.5% vs 26.7%, p < 0.001). On multivariable logistic regression, HIV was not associated with increased risk of aortic rupture (OR: 0.79; 95% CI: 0.61-1.01, p = 0.06), acute aortic dissection (OR: 0.73; 95% CI: 0.51-1.06, p = 0.3), readmissions (OR: 1.04; 95% CI: 0.95-1.13, p = 0.4), or aortic repair (OR: 0.89; 95% CI: 0.79-1.00, p = 0.05). Hospitalized patients with AA and HIV had a lower crude mortality rate compared to those without HIV (OR: 0.75 (0.63-0.91), p = 0.003). Hospitalized patients with AA and HIV likely constitute a distinct group of patients with AA; they are younger, have fewer traditional cardiovascular risk factors, and a higher rate of thoracic aorta involvement. Differences in clinical features may account for the lower mortality rate observed in patients with AA and HIV compared to those without HIV.

Incidence and Outcomes of Gastrointestinal Bleeding in Patients With Percutaneous Mechanical Circulatory Support Devices.

Percutaneous mechanical circulatory support (pMCS) devices are increasingly used in patients with cardiogenic shock as a bridge to recovery or bridge to decision to advanced heart failure therapies. Gastrointestinal bleeding (GIB) is a common complication that can be catastrophic. Because of the paucity of data describing the association of GIB with pMCS, we analyzed this population using the United States National Inpatient Sample database. We performed a retrospective study in patients with pMCS devices who had GIB during the index hospitalization using the National Inpatient Sample. Multivariate logistic regression analysis was performed to determine independent predictors of GIB in these patients. A total of 466,627 patients were included. We observed an overall increase in the incidence of adjusted GIB from 2.9% to 3.5% (p = 0.0025) from 2005 to 2014. In comparison to patients without GIB, those with GIB had significantly higher in-hospital mortality, length of stay, and hospitalization cost. In addition to the usual co-morbid conditions, the presence of small bowel and colonic ischemia, colon cancer, diverticulosis, chronic liver disease, and peptic ulcer disease were noted to be significant predictors of GIB for all (p <0.001). In conclusion, patients with pMCS and GIB have higher in-hospital mortality, longer length of stay, and higher cost of hospitalization. Awareness of patient risk factors for bleeding and gastrointestinal disorders are important before the use of mechanical circulatory support devices because they are associated with a substantially higher risk for bleeding.

Assessing race and ethnicity differences in outcomes based on GDMT and target NT-proBNP in patients with heart failure with reduced ejection fraction: An analysis of the GUIDE-IT study.

BACKGROUND: The GUIDE-IT trial was, a multicenter, randomized, parallel group, unblinded study that randomized patients to having heart failure therapy titrated to achieve an NT-proBNP <1000 pg/mL or to usual clinical care. METHODS AND RESULTS: We performed pre-specified subgroup analysis to look for the race and ethnicity-based differences in clinical outcomes of patients who were able to achieve GDMT or target NT-proBNP concentration of ≤1000 pg/mL at 90 days of follow-up. There were 894 patients enrolled in GUIDE-IT study. Of these, 733 participants had available data on 90-day guideline directed triple therapy and 616 on NT-proBNP. 35% of the patients were Black and 6% were Hispanic. Black patients were younger, had more comorbidities, lower EF, and higher NYHA class compared with non-Black. Adjusting for 90-day NT-proBNP and important baseline covariates, Black patients were at a higher risk than non-Black patients for HF hospitalization [HR, 2.19; 95% CI, 1.51-3.17; p < 0.0001], but at a similar risk for mortality [HR, 0.85.; 95% CI, 0.44-1.66; p = 0.64]. Similar results were seen adjusting for 90-day GDMT [HF hospitalization: Black vs non-Black, HR: 1.97; 1.41-2.77, P < 0.0001; mortality: HR: 0.70; 0.39-1.26, p = 0.23]. There were no significant differences between Hispanic and non-Hispanic patients with respect to heart failure hospitalization, cardiovascular or all-cause mortality. Over the study period, Black and Hispanic patients experienced smaller changes in physical function and quality of life as measured by the Kansas City Cardiomyopathy Questionnaire overall score. CONCLUSION: Compared to non-Black patients, Black patients in GUIDE-IT study had a higher risk of heart failure hospitalization, but a comparable risk of mortality, despite improved use of GDMT and achievement of similar biomarker targets.

Association of autosomal dominant polycystic kidney disease with cardiovascular disease: a US-National Inpatient Perspective.

PURPOSE: Data on the epidemiology of cardiovascular diseases (CVD) in patients with autosomal dominant polycystic kidney disease (ADPKD) are limited. In this study, we assess the prevalence of CVD in patients with ADPKD and evaluate associations between these two entities. METHODS: Using the National Inpatient Sample database, we identified 71,531 hospitalizations among adults aged ≥ 18 years with ADPKD, from 2006 to 2014 and collected relevant clinical data. RESULTS: The prevalence of CVD in the study population was 42.6%. The most common CVD were ischemic heart diseases (19.3%), arrhythmias (14.2%), and heart failure (13.1%). The prevalence of CVD increased with the severity of renal dysfunction (RD). We found an increase in hospitalizations of patients with ADPKD and CVD over the years (ptrend < 0.01), irrespective of the degree of RD. CVD was the greatest independent predictor of mortality in these patients (OR: 3.23; 95% CI 2.38-4.38 [p < 0.001]). In a propensity matched model of hospitalizations of patients with CKD with and without ADPKD, there was a significant increase in the prevalence of atrial fibrillation/flutter (AF), pulmonary hypertension (PHN), non-ischemic cardiomyopathy (NICM), and hemorrhagic stroke among patients with ADPKD when compared to patients with similar degree of RD without ADPKD. CONCLUSIONS: The prevalence of CVD is high among patients with ADPKD, and the most important risk factor associated with CVD is severity of RD. We found an increase in the trend of hospitalizations of patients with ADPKD associated with increased risk of AF, PHN, NICM, and hemorrhagic stroke. History of CVD is the strongest predictor of mortality among patients with ADPKD.

Overview of the FDA's Circulatory System Devices Panel virtual meeting on the TransMedics Organ Care System (OCS) Heart - portable extracorporeal heart perfusion and monitoring system.

There are a limited number of donor hearts available for transplantation every year, and an even lower number of these hearts actually undergo transplantation. One of the barriers to utilizing donor hearts is the inferior outcomes associated with prolonged ischemic times. There have been increasing attempts to develop alternative techniques for prolonged storage to raise the number of heart transplants while maintaining acceptable outcomes. One such new technology utilizes continuous ex vivo perfusion of the donor heart with oxygenated blood and allows for prolonged storage and preservation times. The TransMedics Organ Care System (OCS) Heart (TransMedics; Andover, MA) claims to optimize the condition of the donor organs by preserving them in a warm, functioning environment. On April 6, 2021, the United States Food and Drug Administration convened a virtual meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to provide guidance on the TransMedics OCS Heart System's application for premarket approval. This application was subsequently approved on September 7, 2021. We provide an overview of the meeting, including the results of the clinical trials that were presented.