Catheter-based therapy for high-risk or intermediate-risk pulmonary embolism: death and re-hospitalization.

BACKGROUND AND AIMS: Catheter-based therapies (CBTs) have been developed as a treatment option in patients with pulmonary embolism (PE). There remains a paucity of data to inform decision-making in patients with intermediate-risk or high-risk PE. The aim of this study was to characterize in-hospital and readmission outcomes in patients with intermediate-risk or high-risk PE treated with vs. without CBT in a large retrospective registry. METHODS: Patients hospitalized with intermediate-risk or high-risk PE were identified using the 2017-20 National Readmission Database. In-hospital outcomes included death and bleeding and 30- and 90-day readmission outcomes including all-cause, venous thromboembolism (VTE)-related and bleeding-related readmissions. Inverse probability of treatment weighting (IPTW) was utilized to compare outcomes between CBT and no CBT. RESULTS: A total of 14 903 [2076 (13.9%) with CBT] and 42 829 [8824 (20.6%) with CBT] patients with high-risk and intermediate-risk PE were included, respectively. Prior to IPTW, patients with CBT were younger and less likely to have cancer and cardiac arrest, receive systemic thrombolysis, or be on mechanical ventilation. In the IPTW logistic regression model, CBT was associated with lower odds of in-hospital death in high-risk [odds ratio (OR) 0.83, 95% confidence interval (CI) 0.80-0.87] and intermediate-risk PE (OR 0.76, 95% CI 0.70-0.83). Patients with high-risk PE treated with CBT were associated with lower risk of 90-day all-cause [hazard ratio (HR) 0.77, 95% CI 0.71-0.83] and VTE (HR 0.46, 95% CI 0.34-0.63) readmission. Patients with intermediate-risk PE treated with CBT were associated with lower risk of 90-day all-cause (HR 0.75, 95% CI 0.72-0.79) and VTE (HR 0.66, 95% CI 0.57-0.76) readmission. CONCLUSIONS: Among patients with high-risk or intermediate-risk PE, CBT was associated with lower in-hospital death and 90-day readmission. Prospective, randomized trials are needed to confirm these findings.

Randomized controlled trial of mechanical thrombectomy vs catheter-directed thrombolysis for acute hemodynamically stable pulmonary embolism: Rationale and design of the PEERLESS study.

BACKGROUND: The identification of hemodynamically stable pulmonary embolism (PE) patients who may benefit from advanced treatment beyond anticoagulation is unclear. However, when intervention is deemed necessary by the PE patient's care team, data to select the most advantageous interventional treatment option are lacking. Limiting factors include major bleeding risks with systemic and locally delivered thrombolytics and the overall lack of randomized controlled trial (RCT) data for interventional treatment strategies. Considering the expansion of the pulmonary embolism response team (PERT) model, corresponding rise in interventional treatment, and number of thrombolytic and nonthrombolytic catheter-directed devices coming to market, robust evidence is needed to identify the safest and most effective interventional option for patients. METHODS: The PEERLESS study (ClinicalTrials.gov identifier: NCT05111613) is a currently enrolling multinational RCT comparing large-bore mechanical thrombectomy (MT) with the FlowTriever System (Inari Medical, Irvine, CA) vs catheter-directed thrombolysis (CDT). A total of 550 hemodynamically stable PE patients with right ventricular (RV) dysfunction and additional clinical risk factors will undergo 1:1 randomization. Up to 150 additional patients with absolute thrombolytic contraindications may be enrolled into a nonrandomized MT cohort for separate analysis. The primary end point will be assessed at hospital discharge or 7 days post procedure, whichever is sooner, and is a composite of the following clinical outcomes constructed as a hierarchal win ratio: (1) all-cause mortality, (2) intracranial hemorrhage, (3) major bleeding, (4) clinical deterioration and/or escalation to bailout, and (5) intensive care unit admission and length of stay. The first 4 components of the win ratio will be adjudicated by a Clinical Events Committee, and all components will be assessed individually as secondary end points. Other key secondary end points include all-cause mortality and readmission within 30 days of procedure and device- and drug-related serious adverse events through the 30-day visit. IMPLICATIONS: PEERLESS is the first RCT to compare 2 different interventional treatment strategies for hemodynamically stable PE and results will inform strategy selection after the physician or PERT determines advanced therapy is warranted.

Readmission with infective endocarditis within 90 days following transcatheter aortic valve implantation.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) continues to be the most common modality of treating aortic stenosis in the United States. While infective endocarditis (IE) and its outcomes have been well documented after surgical aortic valve replacement, the incidence and outcomes of early IE after TAVI have not been well described. METHODS: All patients who underwent TAVI from 2012 through 2018 were identified using the National Readmission Database. Among them, patients who underwent TAVI at the index admission and readmitted within 90 days were included. Patients who died or had IE during the index admission were excluded. Clinical outcomes were compared between patients readmitted with IE (IE group) and those without (non-IE group). RESULTS: A total of 168,283 patients were readmitted to a hospital within 90 days after TAVI. The median age of the IE group and non-IE group were 81 and 82 years old, respectively (p = 0.21). Of those, 525 (0.3%) were readmitted with IE. The median time from TAVI to readmission was 20 days. During readmissions, 11.6% of the IE group died while only 3.15% of the non-IE group experienced death (p < 0.001). The most common causative organism of IE was enterococcus (22.1%). Multivariable analysis revealed that congestive heart failure, cerebrovascular disease, dialysis, concomitant valve disease, Medicaid, and discharge to a facility were independently associated with readmission with IE within 90 days. CONCLUSION: The incidence of readmission with IE is low after TAVI. However, the mortality was markedly high during readmissions. Surgical intervention was rarely performed for IE during the first admission. Enterococcus was the most common organism observed in IE after TAVI. DISCLOSURE: IS receives institutional research support from Abbott, Atricure, cryolife, and Medtronic. None related to this manuscript. CLINICAL TRIAL REGISTRATION: Not applicable.

Mechanical thrombectomy versus catheter directed thrombolysis in patients with pulmonary embolism: A multicenter experience.

OBJECTIVES: Compare in-hospital outcomes of patients treated with either mechanical thrombectomy (MT) or catheter directed lysis (CDL) in treatment of acute pulmonary embolism (PE). METHODS: This is a multicenter, retrospective cohort study of patients undergoing MT or CDL for acute PE between 2014 and 2021. The primary outcome was the composite of in-hospital death, significant bleed, vascular complication, or need for mechanical support post-procedure. Secondary outcomes included the individual components of the composite outcome in addition to blood transfusions, invasive hemodynamics, echocardiographic data, and intensive care unit (ICU) utilization. RESULTS: 458 patients were treated for PE with 266 patients in the CDL arm and 192 patients in the MT arm. The primary composite endpoint was not significantly different between the two groups with CDL 12% versus MT 11% (p = 0.5). There was a significant difference in total length of ICU time required with more in the CDL group versus MT (3.8 ± 2.0 vs. 2.8 ± 3.0 days, p = 0.009). All other secondary end points showed no significant difference between the groups. CONCLUSIONS: In patients undergoing catheter directed treatment of PE, there was no difference between MT and CDL in terms of in-hospital mortality, bleeds, catheter-related complications, and hemodynamics.

Coronary Optical Coherence Tomography and Cardiac Magnetic Resonance Imaging to Determine Underlying Causes of Myocardial Infarction With Nonobstructive Coronary Arteries in Women.

BACKGROUND: Myocardial infarction with nonobstructive coronary arteries (MINOCA) occurs in 6% to 15% of myocardial infarctions (MIs) and disproportionately affects women. Scientific statements recommend multimodality imaging in MINOCA to define the underlying cause. We performed coronary optical coherence tomography (OCT) and cardiac magnetic resonance (CMR) imaging to assess mechanisms of MINOCA. METHODS: In this prospective, multicenter, international, observational study, we enrolled women with a clinical diagnosis of myocardial infarction. If invasive coronary angiography revealed <50% stenosis in all major arteries, multivessel OCT was performed, followed by CMR (cine imaging, late gadolinium enhancement, and T2-weighted imaging and T1 mapping). Angiography, OCT, and CMR were evaluated at blinded, independent core laboratories. Culprit lesions identified by OCT were classified as definite or possible. The CMR core laboratory identified ischemia-related and nonischemic myocardial injury. Imaging results were combined to determine the mechanism of MINOCA, when possible. RESULTS: Among 301 women enrolled at 16 sites, 170 were diagnosed with MINOCA, of whom 145 had adequate OCT image quality for analysis; 116 of these underwent CMR. A definite or possible culprit lesion was identified by OCT in 46.2% (67/145) of participants, most commonly plaque rupture, intraplaque cavity, or layered plaque. CMR was abnormal in 74.1% (86/116) of participants. An ischemic pattern of CMR abnormalities (infarction or myocardial edema in a coronary territory) was present in 53.4% (62/116) of participants undergoing CMR. A nonischemic pattern of CMR abnormalities (myocarditis, takotsubo syndrome, or nonischemic cardiomyopathy) was present in 20.7% (24/116). A cause of MINOCA was identified in 84.5% (98/116) of the women with multimodality imaging, higher than with OCT alone (P<0.001) or CMR alone (P=0.001). An ischemic cause was identified in 63.8% of women with MINOCA (74/116), a nonischemic cause was identified in 20.7% (24/116) of the women, and no mechanism was identified in 15.5% (18/116). CONCLUSIONS: Multimodality imaging with coronary OCT and CMR identified potential mechanisms in 84.5% of women with a diagnosis of MINOCA, 75.5% of which were ischemic and 24.5% of which were nonischemic, alternate diagnoses to myocardial infarction. Identification of the cause of MINOCA is feasible and has the potential to guide medical therapy for secondary prevention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02905357.

Percutaneous mechanical thrombectomy in a real-world pulmonary embolism population: Interim results of the FLASH registry.

OBJECTIVES: The FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) is a prospective multi-center registry evaluating the safety and effectiveness of percutaneous mechanical thrombectomy for treatment of pulmonary embolism (PE) in a real-world patient population (NCT03761173). This interim analysis reports outcomes for the first 250 patients enrolled in FLASH. BACKGROUND: High- and intermediate-risk PEs are characterized by high mortality rates, frequent readmissions, and long-term sequelae. Mechanical thrombectomy is emerging as a front-line therapy for PE that enables immediate thrombus reduction while avoiding the bleeding risks inherent with thrombolytics. METHODS: The primary endpoint is a composite of major adverse events (MAE) including device-related death, major bleeding, and intraprocedural device- or procedure-related adverse events at 48 h. Secondary endpoints include on-table changes in hemodynamics and longer-term measures including dyspnea, heart rate, and cardiac function. RESULTS: Patients were predominantly intermediate-risk per ESC guidelines (6.8% high-risk, 93.2% intermediate-risk). There were three MAEs (1.2%), all of which were major bleeds that resolved without sequelae, with no device-related injuries, clinical deteriorations, or deaths at 48 h. All-cause mortality was 0.4% at 30 days, with a single death that was unrelated to PE. Significant on-table improvements in hemodynamics were noted, including an average reduction in mean pulmonary artery pressure of 7.1 mmHg (22.2%, p < 0.001). Patient symptoms and cardiac function improved through follow-up. CONCLUSIONS: These interim results provide preliminary evidence of excellent safety in a real-world PE population. Reported outcomes suggest that mechanical thrombectomy can result in immediate hemodynamic improvements, symptom reduction, and cardiac function recovery.

Outcomes of transcatheter aortic valve replacement at teaching versus nonteaching hospitals.

INTRODUCTION: Prior studies have demonstrated that outcomes of invasive cardiac interventions may vary by hospital teaching status and volume. As transcatheter aortic valve replacement (TAVR) rapidly expands from teaching to nonteaching hospitals across the country, the clinical impact of hospital teaching status has not been clearly established. This study aimed to compare TAVR outcomes between nonteaching and teaching hospitals. METHODS: An observational study was conducted using the Nationwide Readmission Database (NRD). Patients undergoing TAVR from 2011 to 2018 were included. Data was analyzed using multivariable logistic regression to determine outcomes of 30-day mortality and readmission between nonteaching and teaching hospitals. RESULTS: A total of 235,321 patients underwent TAVR during the study period. Patients undergoing TAVR at teaching hospitals presented with a higher frequency of baseline comorbidities compared to nonteaching hospitals. Postprocedure complications such as myocardial infarction, arrhythmia, pneumonia, acute kidney injury, sepsis, stroke, and hemorrhage occurred more often at teaching centers (p < 0.001); translating to a higher rate of in-hospital mortality (2.27% vs. 1.99%, p = 0.006) and hospital cost ($48,300 vs. $44,900, p < 0.001) in teaching versus nonteaching hospitals. After adjusting for baseline characteristics and postoperative morbidity, in-hospital mortality (p = 0.095) and readmission rate (p = 0.420) on multivariable analysis were not statistically different between centers. CONCLUSION: With the evolution and expansion of TAVR to nonteaching centers, mortality, and readmission rates are not significantly different between nonteaching and teaching hospitals. Higher unadjusted in-hospital mortality at teaching centers suggest these centers more often treat high risk patients with associated increased complications.

Long-term Outcomes of Percutaneous Coronary Intervention in Patients with Prior Coronary Artery Bypass Grafting.

BACKGROUND Patients with a prior coronary artery bypass graft (CABG) may have a need for repeat revascularization, which is typically attempted first via percutaneous coronary intervention (PCI) of either a bypass graft or native vessel. Long-term outcomes of native vessel compared to graft PCI after CABG have not yet been explored in a large institution study. METHODS Patients with history of prior CABG who underwent PCI at our institution during 2010-2018 were included. Baseline characteristics and long-term outcomes of up to 5 years were compared between native vessel and bypass graft PCI groups. Cox regression was used to adjust for significant covariates in estimation of risk and calculation of hazard ratios. RESULTS During the study, 4,251 patients with a prior CABG underwent PCI. Native vessel PCI represented 67.1% (n=2,851) of the cohort. After adjusting for significant covariates, bypass graft PCI compared to native vessel PCI had a higher risk of overall mortality (HR 1.15; 95% CI, 1.04-1.29; p<0.05), all-cause readmission (HR 1.16; 95% CI, 1.1-1.3; p<0.05), readmission for PCI (HR 1.25; 95% CI, 1.13-1.38; p<0.05), readmission for heart failure (HR 1.16; 95% CI, 1.06-1.26; p<0.05), and composite of myocardial infarction and revascularization (HR 1.23; 95% CI, 1.12-1.35; p<0.05). CONCLUSIONS Among patients with prior CABG, bypass graft PCI compared to native vessel PCI was associated with higher risk of adverse long-term outcomes.

Relationship between predicting bleeding complication in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score and mortality among patients with atrial fibrillation undergoing percutaneous coronary intervention.

BACKGROUND: The predicting bleeding complication in patients undergoing stent implantation and subsequent dual antiplatelet therapy, PRECISE-DAPT (P-DAPT) score has been validated in large cohorts as an effective tool in predicting bleeding complication after dual antiplatelet therapy (DAPT) as well as in predicting in-hospital mortality. The implication of using this score to predict outcomes, including mortality in patients with atrial fibrillation (AF) undergoing PCI is unknown. OBJECTIVE: Role of P-DAPT score to study clinical outcomes, including mortality, hospitalization, and major bleeding, particularly among patients with AF. METHODS: This is a retrospective observational study of 18,850 consecutive patients who underwent percutaneous coronary intervention (PCI) across a large multihospital healthcare system from 2010 to 2019. Patients were stratified into four groups depending on the presence or absence of AF and P-DAPT score, with score ≥ 25 defined as high risk. The primary outcome was all-cause mortality. The secondary outcomes evaluated were hospitalization and major bleeding. RESULTS: In the unadjusted analyses, a P-DAPT score ≥ 25, in both AF and non-AF population, was associated with increased mortality, hospitalization, and bleeding. After adjusting for baseline covariates, no significant differences in major bleeding risk were found across the four groups. However, a P-DAPT score of ≥25 in AF patients was associated with a higher risk for hospitalizations related to cardiovascular causes (HR: 2.15 95% CI 2.00-2.3, p < .0001). Among AF patients, P-DAPT score ≥ 25 was found to be strongly associated with mortality (HR 3.5; 95% CI 2.95-4.25, p < .0001) as compared with AF patients with score < 25 (HR 1.18, 95% CI 0.88-1.54, p = .26). CONCLUSION: In this large cohort of patients undergoing PCI, the P-DAPT score can help to identify patients at high risk for long-term mortality, particularly among those with atrial fibrillation.

Equipment utilization in chronic total occlusion percutaneous coronary interventions: Insights from the PROGRESS-CTO registry.

BACKGROUND: We examined guidewire and microcatheter utilization during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We examined device utilization in 2,968 CTO PCIs performed in 2,936 patients at 19 US and two international center between January 2016 and January 2019. RESULTS: The median number of antegrade guidewires used per case declined (5 in 2016 vs 3 in 2019) and was higher in higher complexity lesions (2 in J-CTO 0 vs. 8 in J-CTO 4 or 5 score). In antegrade-only procedures, the most frequently used guidewires were the Pilot 200 (Abbott Vascular, 37%), Fielder XT (Asahi Intecc, 25%) and Gaia third (Asahi Intecc, 18%), while the most commonly used microcatheters were the Turnpike Spiral (Vascular Solutions, 18%) and Turnpike (Vascular Solutions, 16%). Compared with 2012-2015, during 2016-2019 use of novel equipment such as the Gaia guidewires and the Turnpike microcatheters led to decreased use of Confianza Pro 12 (Asahi Intecc) wire and Corsair (Asahi Intecc) family of microcatheters. In retrograde cases, the guidewires most commonly used were the Sion (44%), Pilot 200 (27%) and Fielder FC (26%), while the Corsair/Corsair Pro, Turnpike LP (Vascular Solutions) and Caravel (Asahi Intecc) were the most frequently used microcatheters for collateral crossing (29%, 26% and 22%, respectively). CONCLUSIONS: The most commonly used guidewires during CTO PCI are polymer-jacketed guidewires and the most commonly used microcatheters are torquable microcatheters.

Acute right ventricular failure in a patient with nonischemic cardiogenic shock on left-sided mechanical circulatory support.

We report a case of acute right ventricular failure in a patient with cardiogenic shock on left-sided mechanical circulatory support with Impella 5.0. The patient was successfully bridged to heart transplantation using additional right-sided support with Protek Duo. Key learning points of the case include prompt recognition of acute right ventricular failure in patients on left-sided support, early consideration of right-ventricular mechanical support platforms, and timely deployment of right-sided mechanical support.

Urgent transcatheter aortic valve replacement may be performed with acceptable long-term outcomes.

BACKGROUND: The wide availability of transcatheter aortic valve replacement (TAVR) and broadening of its indications to most patients with aortic stenosis may increase its utilization in the urgent setting. However, a comparison of long-term outcomes of patients undergoing urgent TAVR when compared to elective TAVR have not been well studied. METHODS: All patients that underwent TAVR from 2011 to 2018 were included. Primary outcomes included operative (30-day), 1-, and 5-year survival and readmissions. RESULTS: The total patient population undergoing TAVR was divided into urgent (n = 247) and elective (n = 946) cohorts. Thirty days mortality (6.5% vs. 2.3%; p = .001), acute kidney injury (2.8% vs. 0.6%; p = .003), and length of stay (12 vs. 3 days; p < .001) were higher for the urgent cohort. There was no significant difference between cohorts for 30-day all-cause (14.6% vs. 10.8%; p = .097) readmissions. Freedom from readmission for heart failure at 1-year (73.6% vs. 83.4%; p < .001) was lower for the urgent cohort. One- (79.0% vs. 87.1%; p < .001) and five-year (39.6% vs. 43.5%; p = .005) survival was lower for the urgent cohort. This difference was eliminated after risk adjustment (hazard ratio [HR]: 1.3; p = .158 and HR: 1.1; p = .639, respectively). CONCLUSION: Unadjusted survival was significantly worse for the urgent cohort up to 1 year. This trend continued for 5-year survival, however, after risk adjustment there was no significant difference in survival between cohorts. Although urgent TAVR is associated with increased periprocedural risk due to more comorbid disease, outcomes and long-term survival are encouraging and support the consideration of urgent TAVR as a viable alternative for this patient population.

Invasive hemodynamic assessment of patients with submassive pulmonary embolism.

OBJECTIVES: To investigate the invasive hemodynamics in patients with intermediate-risk pulmonary embolism (PE) and the change that occurs with catheter-directed thrombolysis (CDT). BACKGROUND: Intermediate-risk PE is associated with right ventricular strain and worse outcomes yet the invasive hemodynamics have not been well described. METHODS: Ninety-two consecutive patients with intermediate-risk PE referred for CDT at two tertiary medical centers with Pulmonary Embolism Response Teams were included in this prospective cohort study. Hemodynamics at baseline and after CDT therapy was measured. Patients with cardiac index (CI) ≤1.8 L min-1 m-2 were compared to those without shock (CI > 1.8). Linear regression analysis was performed to study the relationship between clinical variables and low CI. RESULTS: Thirty-seven out of 92 (40%) had a CI less than 1.8 L min-1 m-2 . When comparing the low CI to the normal CI groups, most demographics, vital signs, biomarkers, and PE severity index (PESI) scores were similar. The low CI group had more females and slightly lower systolic blood pressures although still in the normal range (122 vs. 132 mmHg, p = .026). Treatment with CDT was associated with significant improvement in CI, heart rate, and pulmonary artery pressures in both groups. Linear regression analysis did not reveal a strong correlation between CI and noninvasive metrics such as heart rate, blood pressure, or PESI score. CONCLUSIONS: Forty percent of patients with submassive PE had a depressed CI and treatment with CDT lead to hemodynamic improvements. Invasive hemodynamics may help better identify higher risk patients and guide therapy.

Percutaneous thrombectomy in patients with massive and very high-risk submassive acute pulmonary embolism.

OBJECTIVE: Examine FlowTriever thrombectomy feasibility in high-risk PE patients. BACKGROUND: The FlowTriever thrombectomy system (Inari Medical, Irvine, CA) can reduce right ventricle (RV) strain in acute submassive pulmonary embolism (PE) patients. This technology has not been studied in higher risk PE patients. METHODS: This multicenter retrospective analysis included patients treated with FlowTriever between 2017 and 2019 if they met at least one of the following: vasopressor dependence, PE induced respiratory failure, or decreased cardiac index (CI) measured by right heart catheterization. RESULTS: Analysis included 34 patients: 18 massive, four intubated, 12 normotensive but with CI < 1.8. Average age was 56 and their median simplified PE severity index was 2. Patients had high bleeding risk, with 13 having recent surgery, six posttrauma, and four recent strokes. Six patients received cardiopulmonary resuscitation, and two received additional mechanical circulatory support. All patients had RV dilatation and elevated biomarkers. Clot removal was successful in 32/34 patients. CI improved from 2.0 ± 0.1 L/min/m2 before thrombectomy to 2.4 ± 0.1 L/min/m2 after (p = .01). The mean pulmonary artery pressure decreased from 33.2 ± 1.6 mmHg to 25.0 ± 1.5 mmHg (p = .01). The two patients-both with no or minimal thrombus removed-deteriorated during the procedure: one died and the other was successfully stabilized on ECMO. There were no other major complications. All other patients were alive at the time of data collection (mean follow-up of 205 days). CONCLUSION: Aspiration thrombectomy appears feasible in higher risk acute PE patients with immediate hemodynamic improvement and low in-hospital mortality.

Incidence, predictors and impact of stroke on mortality among patients with acute coronary syndromes following percutaneous coronary intervention-Results from the PROMETHEUS registry.

BACKGROUND: Stroke represents a potentially calamitous complication among patients with acute coronary syndrome (ACS) undergoing percutaneous intervention (PCI). Data on the distribution of stroke occurrence post-PCI and its impact on mortality are scarce. OBJECTIVES: We sought to determine the incidence, predictors and impact of stroke on mortality in ACS patients undergoing PCI. METHODS: A total of 19,914 ACS patients underwent PCI in the PROMETHEUS multicenter observational study. We calculated the cumulative stroke incidence at 30 days and 1 year using the Kaplan Meier method. We also compared the distribution of stroke, myocardial infarction (MI), and bleeding across time and evaluated their overlap. Predictors of stroke were identified through multivariable Cox-regression. Stroke, MI, and bleeding were assessed as time-updated covariates to estimate how each impacts subsequent mortality. RESULTS: We found that 244 patients had a stroke within 1 year, a cumulative incidence of 1.5%. Previous cerebrovascular disease was the strongest predictor for post-PCI stroke, followed by ST-elevation MI presentation, hypertension, non-ST-elevation MI presentation, smoking, female sex, and age. Mortality risk was significantly higher among those who had a stroke versus those who did not (adjusted HR 4.84, p < .0001). However, the association attenuated over time with a much larger effect in the first 30 days of its occurrence (adjusted HR 17.7; 95% CI: 12.3-25.4, p < .0001) versus beyond 30 days (adjusted HR 1.22; 95% CI: 0.6-2.46, p = .58). CONCLUSIONS: Stroke occurrence within 1 year was not uncommon for ACS patients undergoing PCI. When compared with MI and bleeding, stroke had a substantial impact on mortality that attenuated rapidly over time.

Direct bridging to cardiac transplantation with the surgically implanted Impella 5.0 device.

This study evaluated outcomes of direct bridging to orthotopic heart transplantation (OHT) with the Impella 5.0 device. Adult recipients in the United Network for Organ Sharing registry bridged to OHT with the Impella 5.0 device between 2010 to 2018 were included. Outcomes included waitlist and post-transplant survival. A total of 236 patients were wait-listed with Impella 5.0 support, and 24% (n = 57) underwent bridge to OHT. Early and late post-transplant survival was excellent at 96.5% at 30 day, 93.8% at 90-day, and 90.3% at 1-year follow-up. Post-transplant complications were infrequent, but the most common were renal failure requiring dialysis (8.8%, n = 5), cerebrovascular accidents (1.8%, n = 1), and pacemaker implant (1.8%, n = 1). The rate of waitlist removal for death or clinical deterioration was 20.0% (n = 47); however, the majority of patients were bridged to OHT (24%, n = 57) or durable continuous-flow left ventricular assist device (37.0%, n = 87). The median time supported on the device, while waitlisted was 13 days (Interquartile range [IQR] 7, 20 days). The Impella 5.0 device can be used as a direct bridge to OHT with excellent survival and minimal post-transplant morbidity. Overall, these data support the utilization of Impella 5.0 as a bridge to OHT in select patients with refractory cardiogenic shock.

Use of prasugrel and clinical outcomes in African-American patients treated with percutaneous coronary intervention for acute coronary syndromes.

OBJECTIVE: To investigate the use of prasugrel after percutaneous coronary intervention (PCI) in African American (AA) patients presenting with acute coronary syndrome (ACS). BACKGROUND: AA patients are at higher risk for adverse cardiovascular outcomes after PCI and may derive greater benefit from the use of potent antiplatelet therapy. METHODS: Using the multicenter PROMETHEUS observational registry of ACS patients treated with PCI, we grouped patients by self-reported AA or other races. Clinical outcomes at 90-day and 1-year included non-fatal myocardial infarction (MI), major adverse cardiac events (composite of death, MI, stroke, or unplanned revascularization) and major bleeding. RESULTS: The study population included 2,125 (11%) AA and 17,707 (89%) non-AA patients. AA patients were younger, more often female (46% vs. 30%) with a higher prevalence of diabetes mellitus, chronic kidney disease, and prior coronary intervention than non-AA patients. Although AA patients more often presented with troponin (+) ACS, prasugrel use was much less common in AA vs. non-AA (11.9% vs. 21.4%, respectively, P = 0.001). In addition, the use of prasugrel increased with the severity of presentation in non-AA but not in AA patients. Multivariable logistic regression showed AA race was an independent predictor of reduced use of prasugrel (0.42 [0.37-0.49], P < 0.0001). AA race was independently associated with a significantly higher risk of MI at 90-days and 1 year after PCI. CONCLUSIONS: Despite higher risk clinical presentation and worse 1-year ischemic outcomes, AA race was an independent predictor of lower prasugrel prescription in a contemporary population of ACS patients undergoing PCI.

The prevalence, predictors and outcomes of guideline-directed medical therapy in patients with acute myocardial infarction undergoing PCI, an analysis from the PROMETHEUS registry.

OBJECTIVES: To investigate the prevalence, predictors and associations between guideline-directed medical therapy (GDMT) and clinical outcomes in acute myocardial infarction (AMI) patients undergoing percutaneous coronary intervention (PCI) from eight academic centers in the United States. BACKGROUND: Evidence for GDMT in patients with AMI comes from randomized controlled trials. The use of GDMT in clinical practice is unknown in this setting. METHODS: PROMETHEUS is a multicenter observational registry comprising 19,914 patients with acute coronary syndrome (ACS) undergoing PCI. Patients with AMI were divided into two groups based on the prescription of GDMT or not (non-GDMT) at discharge. GDMT was defined according to American College of Cardiology/American Heart Association (ACC/AHA) class I recommendations, specifically, dual antiplatelet therapy, statin and beta-blocker for all AMI patients, and additional ACEI/ARB in patients with left ventricular ejection fraction (LVEF) less than 40%, hypertension, diabetes mellitus (DM) or chronic kidney disease (CKD). The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of all-cause death, MI, stroke or unplanned target vessel revascularization (TVR) at 1 year. RESULTS: Out of 4,834 patients with AMI, 3,356 (69.4%) patients were discharged on GDMT. Patients receiving GDMT were more often younger and male. Compared with non-GDMT patients, GDMT patients had a significantly lower frequency of comorbidities. Predictors of greater GDMT prescription at discharge were ST-segment elevation myocardial infarction (STEMI), and increased body mass index (BMI), whereas hypertension, prior PCI, anemia and CKD were associated with less GDMT prescription. At 1 year, the use of GDMT was associated with a significantly lower incidence of MACE (13.7% vs. 22.5%; adjusted HR 0.68; 95%CI 0.58-0.80; P < 0.001), death (3.7% vs. 9.4%; adjusted HR 0.61; 95%CI 0.46-0.80; P < 0.001), and unplanned TVR (8.4% vs. 11.3%; adjusted HR 0.76; 95%CI 0.61-0.96; P = 0.020). However, there were no significant differences in the incidence of MI (4.3% vs. 7.0%; adjusted HR 0.75; 95%CI 0.56-1.01; P = 0.056), stroke (1.5% vs. 2.0%; adjusted HR 0.79; 95%CI 0.47-1.34; P = 0.384) between the two groups. CONCLUSION: In a contemporary practice setting in the United States, GDMT was utilized in just over two-thirds of AMI patients undergoing PCI. Predictors of GDMT prescription at discharge included STEMI, BMI and absence of hypertension, CKD, anemia or prior PCI. Use of GDMT was associated with significantly lower risk of 1-year MACE and mortality.

PreSERVE-AMI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Intracoronary Administration of Autologous CD34+ Cells in Patients With Left Ventricular Dysfunction Post STEMI.

RATIONALE: Despite direct immediate intervention and therapy, ST-segment-elevation myocardial infarction (STEMI) victims remain at risk for infarct expansion, heart failure, reinfarction, repeat revascularization, and death. OBJECTIVE: To evaluate the safety and bioactivity of autologous CD34+ cell (CLBS10) intracoronary infusion in patients with left ventricular dysfunction post STEMI. METHODS AND RESULTS: Patients who underwent successful stenting for STEMI and had left ventricular dysfunction (ejection fraction≤48%) ≥4 days poststent were eligible for enrollment. Subjects (N=161) underwent mini bone marrow harvest and were randomized 1:1 to receive (1) autologous CD34+ cells (minimum 10 mol/L±20% cells; N=78) or (2) diluent alone (N=83), via intracoronary infusion. The primary safety end point was adverse events, serious adverse events, and major adverse cardiac event. The primary efficacy end point was change in resting myocardial perfusion over 6 months. No differences in myocardial perfusion or adverse events were observed between the control and treatment groups, although increased perfusion was observed within each group from baseline to 6 months (P<0.001). In secondary analyses, when adjusted for time of ischemia, a consistently favorable cell dose-dependent effect was observed in the change in left ventricular ejection fraction and infarct size, and the duration of time subjects was alive and out of hospital (P=0.05). At 1 year, 3.6% (N=3) and 0% deaths were observed in the control and treatment group, respectively. CONCLUSIONS: This PreSERVE-AMI (Phase 2, randomized, double-blind, placebo-controlled trial) represents the largest study of cell-based therapy for STEMI completed in the United States and provides evidence supporting safety and potential efficacy in patients with left ventricular dysfunction post STEMI who are at risk for death and major morbidity. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01495364.

Associations between use of prasugrel vs clopidogrel and outcomes by type of acute coronary syndrome: an analysis from the PROMETHEUS registry.

We sought to investigate the utilization of prasugrel and its association with outcomes relative to clopidogrel in three typical subgroups of ACS in a real-world setting. Prasugrel is superior to clopidogrel for reducing risk of ischemic events in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI), but is associated with an increased risk of bleeding complications. PROMETHEUS was a retrospective multicenter observational study of 19,913 ACS patients undergoing PCI from 8 centers in the United States between 2010 and 2013. Major adverse cardiovascular events (MACE) were defined as a composite of all-cause mortality, myocardial infarction, stroke or unplanned revascularization. The study cohort included 3285 (16.5%) patients with ST-segment elevation myocardial infarction (STEMI), 5412 (27.2%) patients with NSTEMI and 11,216 (56.3%) patients with unstable angina (UA). The frequency of prasugrel use at discharge was highest in STEMI and lowest in UA patients, 27.3% versus 22.2% versus 18.9% (p < 0.001). Use of prasugrel vs clopidogrel was associated with a lower rate of MACE in STEMI, NSTEMI, or UA at 1 year, but the differences were attenuated for all groups except for patients with UA (adjusted HR 0.81, 95% CI 0.69-0.94, p = 0.006) after propensity adjusted analysis. After adjustment, there was no difference in bleeding risk between prasugrel and clopidogrel for all groups at 1 year. STEMI patients were more likely to receive prasugrel compared to NSTEMI and UA patients. Prasugrel was associated with reduced adverse outcomes compared with clopidogrel in unadjusted analyses, findings that were largely attenuated upon adjustment and suggest preferential use of prasugrel in low vs high risk patients.