Ventricular Arrhythmias After Primary Percutaneous Coronary Intervention for STEMI.

Importance: Currently, mortality risk for patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) with an uncomplicated postprocedure course is low. Less is known regarding the risk of in-hospital ventricular tachycardia (VT) and ventricular fibrillation (VF). Objective: To evaluate the risk of late VT and VF after primary PCI for STEMI. Design, Setting, and Participants: This cohort study included adults aged 18 years or older with STEMI treated with primary PCI between January 1, 2015, and December 31, 2018, identified in the US National Cardiovascular Data Registry Chest Pain-MI Registry. Data were analyzed from April to December 2020. Main Outcomes and Measures: Multivariable logistic regression was used to evaluate the risk of late VT (≥7 beat run of VT during STEMI hospitalization ≥1 day after PCI) or VF (any episode of VF≥1 day after PCI) associated with cardiac arrest and associations between late VT or VF and in-hospital mortality in the overall cohort and a cohort with uncomplicated STEMI without prior myocardial infarction or heart failure, systolic blood pressure less than 90 mm Hg, cardiogenic shock, cardiac arrest, reinfarction, or left ventricular ejection fraction (LVEF) less than 40%. Results: A total of 174 126 eligible patients with STEMI were treated with primary PCI at 814 sites in the study; 15 460 (8.9%) had VT or VF after primary PCI, and 4156 (2.4%) had late VT or VF. Among the eligible patients, 99 905 (57.4%) at 807 sites had uncomplicated STEMI. The median age for patients with late VT or VF overall was 63 years (IQR, 55-73 years), and 75.5% were men; the median age for patients with late VT or VF with uncomplicated STEMI was 60 years (IQR, 53-69 years), and 77.7% were men. The median length of stay was 3 days (IQR, 2-7 days) for the overall cohort with late VT or VF and 3 days (IQR, 2-4 days) for the cohort with uncomplicated STEMI with late VT or VF. The risk of late VT or VF was 2.4% (overall) and 1.7% (uncomplicated STEMI). Late VT or VF with cardiac arrest occurred in 674 patients overall (0.4%) and in 117 with uncomplicated STEMI (0.1%). LVEF was the most significant factor associated with late VT or VF with cardiac arrest (adjusted odds ratio [AOR] for every 5-unit decrease ≤40%: 1.67; 95% CI, 1.54-1.85). Late VT or VF events were associated with increased odds of in-hospital mortality in the overall cohort (AOR, 6.40; 95% CI, 5.63-7.29) and the cohort with uncomplicated STEMI (AOR, 8.74; 95% CI, 6.53-11.70). Conclusions and Relevance: In this study, a small proportion of patients with STEMI treated with primary PCI had late VT or VF. However, late VT or VF with cardiac arrest was rare, particularly in the cohort with uncomplicated STEMI. This information may be useful when determining the optimal timing for hospital discharge after STEMI.

Outcomes and Institutional Variation in Arterial Access Among Patients With AMI and Cardiogenic Shock Undergoing PCI.

BACKGROUND: Contemporary data comparing the outcomes of transradial access (TRA) vs transfemoral access (TFA) among patients presenting with acute myocardial infarction and cardiogenic shock (AMI-CS) undergoing percutaneous coronary intervention (PCI) are limited. OBJECTIVES: This study examines in-hospital outcomes and institutional variation among patients with AMI-CS undergoing TRA-PCI vs TFA-PCI. METHODS: Patients admitted with AMI-CS from the NCDR CathPCI registry between April 2018 and June 2021 were included. Multivariable logistic regression and inverse probability weighting models were used to assess the association between access site and in-hospital outcomes. A falsification analysis using non-access site-related bleeding was performed. RESULTS: Among 35,944 patients with AMI-CS undergoing PCI, 25.6% were performed with TRA. The proportion of TRA-PCI increased over the study period (22.0% in the second quarter of 2018 vs 29.1% in the second quarter of 2021; P-trend <0.001). Significant institutional-level variability in the use of TRA-PCI was also observed: 20.9% of all sites using TRA in <2% of PCIs (low utilization) vs 1.9% of all sites using TRA in >80% of PCIs (high utilization). Patients undergoing TRA-PCI had a significantly lower adjusted incidence of major bleeding (odds ratio [OR]: 0.71; 95% confidence interval [CI]: 0.67-0.76), mortality (OR: 0.73; 95% CI: 0.69-0.78), vascular complications (OR: 0.67; 95% CI: 0.54-0.84), and new dialysis (OR: 0.86; 95% CI: 0.77-0.97). There was no difference in non-access site related bleeding (OR: 0.93; 95% CI: 0.84-1.03). Sensitivity analyses revealed similar benefit with TRA-PCI among patients without arterial cross-over. There were no significant interactions observed between TRA-PCI with mechanical circulatory support and in-hospital outcomes. CONCLUSIONS: In this large nationwide contemporary analysis of patients with AMI-CS, about quarter of PCIs were performed via TRA with wide variability across US institutions. TRA-PCI was associated with significantly lower incidence of in-hospital major bleeding, mortality, vascular complications, and new dialysis. This benefit was observed irrespective of mechanical circulatory support use.

Challenge in Predicting Persistence to P2Y12 Inhibitors: A Perspective From the ARTEMIS Trial.

Background Premature discontinuation of P2Y12 inhibitor therapy has been associated with adverse cardiac events, which might be preventable by improving medication persistence. Current risk models have limited ability to predict patients at risk of P2Y12 inhibitor nonpersistence. Methods and Results ARTEMIS (Affordability and Real-World Antiplatelet Treatment Effectiveness after Myocardial Infarction Study) was a randomized, controlled trial testing the impact of a copayment assistance intervention on P2Y12 inhibitor persistence and outcomes. Among 6212 patients post myocardial infarction with a planned 1-year course of P2Y12 inhibitor therapy, nonpersistence was defined as a gap in P2Y12 inhibitor filled >30 days by pharmacy fill data. We developed a predictive model for 1-year P2Y12 inhibitor nonpersistence among patients randomized to usual care. P2Y12 inhibitor nonpersistence rates were 23.8% (95% CI, 22.7%-24.8%) at 30 days and 47.9% (46.6%-49.1%) at 1 year; the majority of these patients had in-hospital percutaneous coronary intervention. Patients who received the copayment assistance intervention had nonpersistence rates of 22.0% (20.7%-23.3%) at 30 days and 45.3% (43.8%-46.9%) at 1 year. A 53-variable multivariable model predicting 1-year persistence had a C-index of 0.63 (optimism-corrected C-index 0.58). Model discrimination did not improve with inclusion of patient-reported perceptions about disease, medication-taking beliefs, and prior medication-filling behavior in addition to demographic and medical history data (C-index 0.62). Conclusions Despite addition of patient-reported variables, models predicting persistence with P2Y12 inhibitor therapy performed poorly, thereby suggesting the need for continued patient and clinician education on the importance of P2Y12 inhibitor therapy after acute myocardial infarction. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02406677.

Modeling the Association of Volume vs Composite Outcome Thresholds With Outcomes and Access to Transcatheter Aortic Valve Implantation in the US.

Importance: Professional societies and the Centers for Medicare & Medicaid Services suggest volume thresholds to ensure quality in transcatheter aortic valve implantation (TAVI). Objective: To model the association of volume thresholds vs spoke-and-hub implementation of outcome thresholds with TAVI outcomes and geographic access. Design, Setting, and Participants: This cohort study included patients who enrolled in the US Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry. Site volume and outcomes were determined from a baseline cohort of adults undergoing TAVI between July 1, 2017, and June 30, 2020. Exposures: Within each hospital referral region, TAVI sites were categorized by volume (<50 or ≥50 TAVIs per year) and separately by risk-adjusted outcome on the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy 30-day TAVI composite during the baseline period (July 2017 to June 2020). Outcomes of patients undergoing TAVIs from July 1, 2020, to March 31, 2022, were then modeled as though the patients had been treated at (1) the nearest higher volume (≥50 TAVIs per year) or (2) the best outcome site within the hospital referral region. Main Outcomes and Measures: The primary outcome was the absolute difference in events between the adjusted observed and modeled 30-day composite of death, stroke, major bleeding, stage III acute kidney injury, and paravalvular leak. Data are presented as the number of events reduced under the above scenarios with 95% bayesian credible intervals (CrIs) and median (IQR) driving distance. Results: The overall cohort included 166 248 patients with a mean (SD) age of 79.5 (8.6) years; 74 699 (47.3%) were female and 6657 (4.2%) were Black; 158 025 (95%) were treated in higher-volume sites (≥50 TAVIs) and 75 088 (45%) were treated in best-outcome sites. Modeling a volume threshold, there was no significant reduction in estimated adverse events (-34; 95% CrI, -75 to 8), while the median (IQR) driving time from the existing site to the alternate site was 22 (15-66) minutes. Transitioning care to the best outcome site in a hospital referral region resulted in an estimated 1261 fewer adverse outcomes (95% CrI, 1013-1500), while the median (IQR) driving time from the original site to the best site was 23 (15-41) minutes. Directionally similar findings were observed for Black individuals, Hispanic individuals, and individuals from rural areas. Conclusions and Relevance: In this study, compared with the current system of care, a modeled outcome-based spoke-and-hub paradigm of TAVI care improved national outcomes to a greater extent than a simulated volume threshold, at the cost of increased driving time. To improve quality while maintaining geographic access, efforts should focus on reducing site variation in outcomes.

Characteristics, Process Metrics, and Outcomes Among Patients With ST-Elevation Myocardial Infarction in Rural vs Urban Areas in the US: A Report From the US National Cardiovascular Data Registry.

Importance: Patients with ST-segment elevation myocardial infarction (STEMI) living in rural settings often have worse clinical outcomes compared with their urban counterparts. Whether this discrepancy is due to clinical characteristics or delays in timely reperfusion with primary percutaneous coronary intervention (PPCI) or fibrinolysis is unclear. Objective: To assess process metrics and outcomes among patients with STEMI in rural and urban settings across the US. Design, Setting, and Participants: This cross-sectional multicenter study analyzed data for 70 424 adult patients with STEMI from the National Cardiovascular Data Registry Chest Pain-MI Registry in 686 participating US hospitals between January 1, 2019, and June 30, 2020. Patients without a valid zip code were excluded, and those transferred to a different hospital during the course of the study were excluded from outcome analysis. Main Outcomes and Measures: In-hospital mortality and time-to-reperfusion metrics. Results: This study included 70 424 patients with STEMI (median [IQR] age, 63 [54-73] years; 49 850 [70.8%] male and 20 574 [29.2%] female; patient self-reported race: 6753 [9.6%] Black, 60 114 [85.4%] White, and 2096 [3.0%] of another race [including American Indian, Alaskan Native, Native Hawaiian, and Pacific Islander]; 5281 [7.5%] individuals of Hispanic or Latino ethnicity) in 686 hospitals (50 702 [72.0%] living in urban zip codes and 19 722 [28.0%] in rural zip codes). Patients from rural settings were less likely to undergo PPCI compared with patients from urban settings (14 443 [73.2%] vs 43 142 [85.1%], respectively; P < .001) and more often received fibrinolytics (2848 [19.7%] vs 937 [2.7%]; P < .001). Compared with patients from urban settings, those in rural settings undergoing PPCI had longer median (IQR) time from first medical contact to catheterization laboratory activation (30 [12-42] minutes vs 22 [15-59] minutes; P < .001) and longer median (IQR) time from first medical contact to device (99 minutes [75-131] vs 81 [66-103] minutes; P < .001), including those who arrived directly at PPCI centers (83 [66-107] minutes vs 78 [64-97] minutes; P < .001) and those who transferred to PPCI centers from another treatment center (125 [102-163] minutes vs 103 [85-135] minutes; P < .001). Among those who transferred in, median (IQR) door-in-door-out time was longer in patients from rural settings (63 [41-100] minutes vs 50 [35-80] minutes; P < .001). Out-of-hospital cardiac arrest was more common in patients from urban vs rural settings (3099 [6.1%] vs 958 [4.9%]; P < .001), and patients from urban settings were more likely to present with heart failure (4112 [8.1%] vs 1314 [6.7%]; P < .001). After multivariable adjustment, there was no significant difference in in-hospital mortality between rural and urban groups (adjusted odds ratio, 0.97; 95% CI, 0.89-1.06). Conclusions and Relevance: In this large cohort of patients with STEMI from US hospitals participating in the National Cardiovascular Data Registry Chest Pain-MI Registry, patients living in rural settings had longer times to reperfusion, were less likely to receive PPCI or meet guideline-recommended time to reperfusion, and more frequently received fibrinolytics than patients living in urban settings. However, there was no difference in adjusted in-hospital mortality between patients with STEMI from urban and rural settings.

Association of Transcatheter Aortic Valve Replacement Reimbursement, New Technology Add-on Payment, and Procedure Volumes With Embolic Protection Device Use.

Importance: In the setting of uncertain efficacy and additional, unreimbursed cost, use of an embolic protection device (EPD) during transcatheter aortic valve replacement (TAVR) has had variable uptake. The Centers for Medicare & Medicaid Services (CMS) instituted a new technology add-on payment to cover EPD use in October 2018. Objective: To evaluate the association between CMS TAVR reimbursement rates and EPD use. Design, Setting, and Participants: This cohort study used the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry to identify patients who underwent TAVR between January 2018 and September 2019. Analysis took place between July 2020 and February 2022. Main Outcomes and Measures: The association between EPD use and CMS reimbursement was assessed using multivariable logistic regression models adjusted for patient characteristics (model 1) and patient/hospital (annualized TAVR volume and teaching status) characteristics (model 2). Results: Among 511 institutions, CMS reimbursement for TAVR ranged from $28 062 to $111 280 with a median (IQR) of $45 884 ($40 331-$53 627). Among 84 353 patients (median [IQR] age, 81.0 [75.0-86.0] years; 46 247 male individuals [54.8%]; 3958 [4.7%] of Hispanic or Latino ethnicity; 78 170 White individuals [92.7%]) treated at the sites, 6012 (7.1%) underwent TAVR with EPD. Patient characteristics associated with EPD use included prior stroke (adjusted odds ratio [aOR], 1.13 [95% CI, 1.00-1.27]; P = .048), female sex (aOR, 0.85 [95% CI, 0.78-0.93]; P < .001), hemodialysis (aOR, 0.52 [95% CI, 0.40-0.68]; P < .001), and shock (aOR, 0.62 [95% CI, 0.41-0.94]; P = .03). Higher CMS reimbursement up to $50 000 per TAVR was associated with greater likelihood of EPD use in model 1 (per $1000; aOR, 1.08 [95% CI, 1.01-1.16]; P = .02). However, this association was no longer apparent after adjusting for site characteristics (model 2; aOR, 1.03 [95% CI, 0.96-1.11]; P = .38). Higher TAVR volume was associated with increased EPD use (per 25 TAVRs; aOR, 1.15 [95% CI, 1.09-1.21]; P < .001). There was no significant change in the odds of EPD uptake before vs after institution of the CMS new technology add-on payment across tertiles of CMS TAVR reimbursement (Wald χ2 = 3.59; P = .17). Conclusions and Relevance: EPD use during TAVR remains infrequent and is associated with multiple patient and site characteristics. While CMS reimbursement varies significantly across institutions, TAVR case volume, rather than CMS TAVR reimbursement or the CMS new technology add-on payment, appears to be the predominant factor associated with EPD use. Ongoing work is needed to understand the economic drivers that contribute to the association between procedural volume and EPD use.

Anxiety and Depression Following Aortic Valve Replacement.

Background The aim of this study was to identify patients vulnerable for anxiety and/or depression following aortic valve replacement (AVR) and to evaluate factors that may mitigate this risk. Methods and Results This is a retrospective cohort study conducted using a claims database; 18 990 patients (1/2013-12/2018) ≥55 years of age with 6 months of pre-AVR data were identified. Anxiety and/or depression risk was compared at 3 months, 6 months, and 1 year following transcatheter aortic valve replacement or surgical AVR (SAVR) after risk adjustment using logistic regression and Cox proportional hazards models. Separate models were estimated for patients with and without surgical complications and discharge location. Patients with SAVR experienced a higher relative risk of anxiety and/or depression at 3 months (12.4% versus 8.8%; adjusted hazard ratio [HR] 1.39 [95% CI, 1.19-1.63]) and 6 months (15.6% versus 13.0%; adjusted HR, 1.24 [95% CI, 1.08-1.42]), with this difference narrowing by 12 months (20.1% versus 19.3%; adjusted HR, 1.14 [95% CI, 1.01-1.29]) after AVR. This association was most pronounced among patients discharged to home, with patients with SAVR having a higher relative risk of anxiety and/or depression. In patients who experienced operative complications, there was no difference between SAVR and transcatheter aortic valve replacement. However, among patients without operative complications, patients with SAVR had an increased risk of postoperative anxiety and/or depression at 3 months (adjusted HR, 1.47 [95% CI, 1.23-1.75]) and 6 months (adjusted HR 1.26 [95% CI, 1.08-1.46]), but not at 12 months. Conclusions There is an associated reduction in the risk of new-onset anxiety and/or depression among patients undergoing transcatheter aortic valve replacement (versus SAVR), particularly in the first 3 and 6 months following treatment.

Sex Differences in Management and Outcomes of Acute Myocardial Infarction Patients Presenting With Cardiogenic Shock.

OBJECTIVES: The aim of this study was to examine the sex differences in the risk profile, management, and outcomes among patients presenting with acute myocardial infarction cardiogenic shock (AMI-CS). BACKGROUND: Contemporary clinical data regarding sex differences in the management and outcomes of AMI patients presenting with CS are scarce. METHODS: Patients admitted with AMI-CS from the National Cardiovascular Data Registry Chest Pain-MI registry between October 2008 to December 2017 were included. Sex differences in baseline characteristics, in-hospital management, and outcomes were compared. Patients ≥65 years of age with available linkage data to Medicare claims were included in the analysis of 1-year outcomes. Multivariable logistic regression and Cox proportional hazards models adjusting for patient and hospital-related covariates were used to estimate sex-specific differences in in-hospital and 1-year outcomes, respectively. RESULTS: Among 17,195 patients presenting with AMI-CS, 37.3% were women. Women were older, had a higher prevalence of comorbidities, and had worse renal function at presentation. Women were less likely to receive guideline-directed medical therapies within 24 hours and at discharge, undergo diagnostic angiography (85.0% vs 91.1%), or receive mechanical circulatory support (25.4% vs 33.8%). Women had higher risks of in-hospital mortality (adjusted OR: 1.10; 95% CI: 1.02-1.19) and major bleeding (adjusted OR: 1.23; 95% CI: 1.12-1.34). For patients ≥65 years of age, women did not have a higher risk of all-cause mortality (adjusted HR: 0.98; 95% CI: 0.88-1.09) and mortality or heart failure hospitalization (adjusted HR: 1.01; 95% CI: 0.91-1.12) at 1 year compared with men. CONCLUSIONS: In this large nationwide analysis of patients with AMI-CS, women were less likely to receive guideline recommended care, including revascularization, and had worse in-hospital outcomes than men. At 1 year, there were no sex differences in the risk of mortality. Efforts are needed to address sex disparities in the initial care of AMI-CS patients.

Strategies for Mechanical Right Ventricular Support During Left Ventricular Assist Device Implant.

BACKGROUND: Refractory right ventricular failure at the time of left ventricular assist device implantation requires treatment with supplemental mechanical circulatory support. However, the optimal strategy for support remains unknown. METHODS: All patients undergoing first-time durable left ventricular assist device implantation with a contemporary device were selected from The Society of Thoracic Surgeons National Database (2011 to 2019). Patients requiring right ventricular assist device (RVAD) or venoarterial extracorporeal membrane oxygenation (VA-ECMO) were included in the analysis. Patients were stratified by RVAD or VA-ECMO and by timing of placement (intraoperative vs postoperative). RESULTS: In all, 18 423 left ventricular assist device implants were identified, of which 940 (5.1%) required RVAD (n = 750) or VA-ECMO (n = 190) support. Patients receiving an RVAD more frequently had preoperative inotrope requirement (76% vs 62%, P < .01) and severe tricuspid regurgitation (20% vs 13%, P < .01). The RVAD patients had lower rates of postoperative renal failure (40% vs 51%, P = .02) and limb ischemia (4% vs 13%, P < .01), as well as significantly less operative mortality (41% vs 54%, P < .01). After risk adjustment with propensity score analysis, support with VA-ECMO was associated with a higher risk of mortality (risk ratio 1.46; 95% confidence interval, 1.21 to 1.77; P < .01) compared with patients receiving an RVAD. Importantly, institution of right ventricular support postoperatively was associated with higher mortality (1.43, P < .01) compared with intraoperative initiation. CONCLUSIONS: Patients with severe right ventricular failure in the setting of durable left ventricular assist device implantation may benefit from the use of RVAD over VA-ECMO. Regardless of the type of support, initiation at the index operation was associated with improved outcomes.

Transesophageal Echocardiography in Patients Undergoing Coronary Artery Bypass Graft Surgery.

BACKGROUND: The impact of utilization of intraoperative transesophageal echocardiography (TEE) at the time of isolated coronary artery bypass grafting (CABG) on clinical decision making and associated outcomes is not well understood. OBJECTIVES: The purpose of this study was to determine the association of TEE with post-CABG mortality and changes to the operative plan. METHODS: A retrospective cohort study of planned isolated CABG patients from the Society of Thoracic Surgeons Adult Cardiac Surgery Database between January 1, 2011, and June 30, 2019, was performed. The exposure variable of interest was use of intraoperative TEE during CABG compared with no TEE. The primary outcome was operative mortality. The association of TEE with unplanned valve surgery was also assessed. RESULTS: Of 1,255,860 planned isolated CABG procedures across 1218 centers, 676,803 (53.9%) had intraoperative TEE. The percentage of patients receiving intraoperative TEE increased over time from 39.9% in 2011 to 62.1% in 2019 (p trend <0.0001). CABG patients undergoing intraoperative TEE had lower odds of mortality (adjusted odds ratio: 0.95; 95% confidence interval: 0.91 to 0.99; p = 0.025), with heterogeneity across STS risk groups (p interaction = 0.015). TEE was associated with increased odds of unplanned valve procedure in lieu of planned isolated CABG (adjusted odds ratio: 4.98; 95% confidence interval: 3.98 to 6.22; p < 0.0001). CONCLUSIONS: Intraoperative TEE usage during planned isolated CABG is associated with lower operative mortality, particularly in higher-risk patients, as well as greater odds of unplanned valve procedure. These findings support usage of TEE to improve outcomes for isolated CABG for high-risk patients.

Aortic Annular Enlargement in the Elderly: Short and Long-Term Outcomes in the United States.

BACKGROUND: Patient prosthesis mismatch is associated with significant long-term morbidity and mortality after aortic valve replacement, but the role and outcomes of annular enlargement (AE) remain poorly defined. We hypothesized that increasing rates of AE may lead to improved outcomes for patients at risk for severe patient prosthesis mismatch. METHODS: Patients over age 65 years undergoing surgical aortic valve replacement with or without coronary artery bypass grafting from 2008-2016 in The Society of Thoracic Surgeons Adult Cardiac Surgery Database with matching Centers for Medicare & Medicaid Services data were included (n=189,268). Univariate, multivariate, and time-to-event analysis was used to evaluate the association between AE and early and late outcomes. Patients were stratified by projected degree of patient prosthesis mismatch based on calculated effective orifice area index. RESULTS: A total of 5412 (2.9%) patients underwent AE. The Society of Thoracic Surgeons Adult Cardiac Surgery Database-predicted mortality was similar between AE and non-AE groups (2.97% vs 2.99%, P = .052). Patients undergoing AE had higher risk-adjusted rates of 30-day complications and death (5.4% vs 3.4%, P < .0001), but no differences in long-term rates of stroke, heart failure re-hospitalization,s or aortic valve reoperation. Survival analysis demonstrated a higher risk of mortality with AE during the first 3 years, after which the survival curves cross, favoring AE. CONCLUSIONS: These data suggest that annular enlargement during surgical aortic valve replacement is associated with increased short-term risk in a Medicare population. Survival curves crossed after 3 years, which may portend a benefit in select patients. However, annular enlargement is still only performed in the minority of patients who are at risk for patient prosthesis mismatch.

Site-Level Variability in 30-Day Patient Outcomes After Transcatheter Mitral Valve Repair in the United States.

BACKGROUND: Clinical trials have demonstrated health status benefit of transcatheter mitral valve repair (TMVr) with MitraClip in patients with mitral valve regurgitation. Real-world site-level variability in health status outcomes for TMVr, and factors associated with this variability, are unknown. METHODS: All patients undergoing TMVr procedure with MitraClip between November 2013 and March 2019 in the Transcatheter Valve Therapy Registry were included. Health status was measured at baseline and 30 days with the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score. Site-level variability in 30-day change in KCCQ-OS was examined by calculating the median odds ratio from a hierarchical logistic regression model, with ≥20-point improvement as the dependent variable. To define the extent to which patient characteristics, procedural characteristics (residual mitral valve regurgitation, periprocedural bleeding), site volume, and patients' baseline health status accounted for variability in outcomes, the proportion of variability (R2) explained by sequentially adding these variables to the model was quantified. RESULTS: Across 339 sites, 12 415 patients (mean age 79.0±9.5 years, 46.1%. females, 89.5% White) completed baseline and 30-day health status assessments. Mean KCCQ-OS score was 43.0±24.4 at baseline and 67.0±24.9 at 30-day follow-up. Across sites, the proportion of patients achieving a ≥20-point improvement in KCCQ-OS ranged from 12.5% to 100% and the adjusted median odds ratio was 1.58 (95% CI, 1.46-1.69). The greatest contribution to the variability in health status outcomes was from patients' baseline KCCQ-OS score (R2=25%) with <1% of the variability explained by patient and procedural characteristics, and annual site volume. CONCLUSIONS: There is moderate variation across sites in their patients' achievement of health status benefits from TMVr, with patient's baseline health status accounting for the largest proportion of this variation. This underscores the importance of patient selection in supporting more consistent health status benefit from TMVr.

Currently Available Options for Mechanical Circulatory Support for the Management of Cardiogenic Shock.

Cardiogenic shock (CS) is a complex condition with a high risk for morbidity and mortality. Mechanical circulatory support (MCS) devices were developed to support patients with CS in cases refractory to treatment with vasoactive medications. Current devices include intra-aortic balloon pumps, intravascular microaxial pumps, percutaneous LVAD, percutaneous RVAD, and VA ECMO. Data from limited observational studies and clinical trials show a clear difference in the level of hemodynamic support offered by each device. However, at this point, there are insufficient clinical trial data to guide MCS selection and, until ongoing clinical trials are completed, use of the right device for the right patient depends largely on clinical judgment.

Navigation of a Dormant AV Fistula for PCI in a Patient With High-Risk NSTEMI.

Arteriovenous (AV) fistulae for hemodialysis in patients with end-stage renal disease usually prevents ipsilateral transradial access (TRA) for coronary angiography. We present a case of coronary angiography and percutaneous coronary intervention via left TRA with navigation through a dormant AV fistula in a patient with limited vascular access. (Level of Difficulty: Intermediate.).

Complications involving the subcutaneous implantable cardioverter-defibrillator: Lessons learned from MAUDE.

BACKGROUND: Reports on the subcutaneous implantable cardioverter-defibrillator (S-ICD) cumulatively demonstrate a low rate of complications, but clinical experience with this technology is limited compared with transvenous devices. OBJECTIVE: The purpose of this study was to describe and analyze S-ICD complications reported to the Food and Drug Administration's Manufacturer and User Facility Device Experience database. METHODS: We reviewed all S-ICD events reported to the Manufacturer and User Facility Device Experience submitted over 24 months (from February 2016 through February 2018) through a prospective and standardized approach at a time when an estimated 15,000 S-ICDs were in service. RESULTS: After removing duplicate entries and nonclinical events (n = 493), 1604 events remained. A total of 542 instances of infection were reported with system removal in 414/542 (77.5%). Inappropriate shocks occurred in 550 patients, and 382 (69%) were attributed to oversensing; in response, 254 (56%), 147 (33%), and 80 (18%) patients underwent system reprogramming, removal, or revision, respectively. There were 15 deaths, and causes included defibrillation failure during follow-up (n = 2), ventricular fibrillation induced by the device (n = 4), device-device interaction resulting in undersensing (n = 1), procedure-related complications (n = 4), and uncertain etiology (n = 4). There were 137 reports of system migration, and in 57 (42%) of these, there were associated inappropriate shocks. System migration events were managed with a combination of system revision (69 [51%]), reprogramming (25 [18%]), and system removal (44 [32%]). CONCLUSION: Several S-ICD complications have been reported that appear to be related to the ICD's design and function over time. A better understanding of these complications may help inform patient selection, implant technique, and postimplantation management.

Cath Lab Robotics: Paradigm Change in Interventional Cardiology?

PURPOSE OF REVIEW: To review the contemporary evidence for robotic-assisted percutaneous coronary and vascular interventions, discussing its current capabilities, limitations, and potential future applications. RECENT FINDINGS: Robotic-assisted cardiovascular interventions significantly reduce radiation exposure and orthopedic strains for interventionalists, while maintaining high rates of device and clinical success. The PRECISE and CORA-PCI studies demonstrated the safety and efficacy of robotic-assisted percutaneous coronary intervention (PCI) in increasingly complex coronary lesions. The RAPID study demonstrated similar findings in peripheral vascular interventions (PVI). Subsequent studies have demonstrated the safety and efficacy of second-generation devices, with automations mimicking manual PCI techniques. While innovations such as telestenting continue to bring excitement to the field, major limitations remain-particularly the lack of randomized trials comparing robotic-assisted PCI with manual PCI. Robotic technology has successfully been applied to multiple cardiovascular procedures. There are limited data to evaluate outcomes with robotic-assisted PCI and other robotic-assisted cardiovascular procedures, but existing data show some promise of improving the precision of PCI while decreasing occupational hazards associated with radiation exposure.