Curtis, Jeptha P.

Abstract Acute myocardial infarction complicated by cardiogenic shock (AMI-CS) is a heterogeneous clinical syndrome associated with substantial morbidity and mortality. We developed a machine learning-based mortality model to identify features and patient subgroups associated with the largest change in mortality risk when evaluating treatment with Impella devices or intra-aortic Balloon Pump (IABP). Our cohort comprised 369 sites and 15,796 patient visits to the cardiac catheterization laboratory from the National Cardiovascular Data Registry. The estimated population mean excess mortality effect of treatment with Impella devices vs IABP was 10.4 ± 0.8%. However, we identified clinical subgroups of 282 patients for whom a decreased risk of mortality was associated with use of Impella as compared with IABP. Those patients were on average younger, presented with higher systolic blood pressure, higher rate of salvage percutaneous coronary intervention, higher initial creatinine, and lower hemoglobin. While Impella devices were associated with higher mortality risk overall, certain clinical profiles were associated with lower risk, illustrating heterogeneity of treatment effects.

Background Percutaneous left atrial appendage occlusion (LAAO) is an alternative to long‐term anticoagulation for preventing ischemic stroke in patients with atrial fibrillation. There are limited long‐term outcomes data for “real‐world” patients undergoing LAAO. Methods We performed a retrospective cohort study using the National Cardiovascular Data Registry LAAO registry from January 1, 2016, through December 31, 2019. We linked LAAO data to inpatient Medicare fee‐for‐service claims data using probabilistic matching to establish a cohort of patients 65 years and older undergoing LAAO with a WATCHMAN device. The primary outcomes were any stroke and all‐cause mortality. Results A total of 34 975 patients with a mean±SD CHA 2 DS 2 ‐VASc (congestive heart failure, hypertension, age ≥75 years, diabetes, previous stroke or transient ischemic attack, vascular disease, age 65 to 74 years, and sex category) score of 4.7±1.4 were included. The median follow‐up was 2.8 years (interquartile range, 2.2–3.7 years). The cumulative incidence of any stroke was 1.57 per 100 person‐years (95% CI, 1.45–1.70), with a 1‐year and 5‐year any stroke estimate of 1.70% (95% CI, 1.57–1.84%) and 5.70% (95% CI, 5.37–6.05%), respectively. The cumulative incidence of ischemic stroke was 1.36 per 100 person‐years (95% CI, 1.25–1.48), with a 1‐year and 5‐year ischemic stroke estimate of 1.42% (95% CI, 1.30–1.54%) and 5.03% (95% CI, 4.71–5.36%), respectively. The cumulative incidence of death was 10.82 per 100 person‐years (95% CI, 10.49–11.13), with a 5‐year mortality estimate of 44.34% (95% CI, 43.35–45.23%). Conclusions Long‐term stroke rates in a large nationally representative cohort of Medicare patients following LAAO were low and durably consistent during long‐term follow‐up despite a high thromboembolic risk. High mortality rates in this elderly population underscore the importance of incorporating patient values and preferences when considering LAAO.

BACKGROUND: The National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry (LAAO) includes the vast majority of transcatheter LAAO procedures performed in the United States. The objective of this study was to develop a model predicting adverse events among patients undergoing LAAO with Watchman FLX. METHODS: Data from 41 001 LAAO procedures with Watchman FLX from July 2020 to September 2021 were used to develop and validate a model predicting in-hospital major adverse events. Randomly selected development (70%, n=28 530) and validation (30%, n=12 471) cohorts were analyzed with 1000 bootstrapped samples, using forward stepwise logistic regression to create the final model. A simplified bedside risk score was also developed using this model. RESULTS: Increased age, female sex, low preprocedure hemoglobin, no prior attempt at atrial fibrillation termination, and increased fall risk most strongly predicted in-hospital major adverse events and were included in the final model along with other clinically relevant variables. The median in-hospital risk-standardized adverse event rate was 1.50% (range, 1.03%–2.84%; interquartile range, 1.42%–1.64%). The model demonstrated moderate discrimination (development C-index, 0.67 [95% CI, 0.65–0.70] and validation C-index, 0.66 [95% CI, 0.62–0.70]) with good calibration. The simplified risk score was well calibrated with risk of in-hospital major adverse events ranging from 0.26% to 3.90% for a score of 0 to 8, respectively. CONCLUSIONS: A transcatheter LAAO risk model using National Cardiovascular Data Registry and LAAO Registry data can predict in-hospital major adverse events, demonstrated consistency across hospitals and can be used for quality improvement efforts. A simple bedside risk score was similarly predictive and may inform shared decision-making.

Background: The Food and Drug Administration approved left atrial appendage occlusion with the Watchman device for patients who are at increased stroke risk and are suitable for oral anticoagulation but who have an appropriate reason to seek a nondrug alternative. These broad criteria raise the question of their interpretation in clinical practice. There is a lack of studies comprehensively evaluating the indications for Watchman implantation among a large series of patients from contemporary, real-world practice in the United States. Methods: We used the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry to identify Watchman procedures performed between 2016 and 2018. We assessed procedural indications for Watchman implantation in the United States and evaluated the association between procedural indications and in-hospital adverse events. Results: A total of 38 314 procedures were included. The mean patient age was 76.1±8.1 years, and 58.9% were men. The mean CHA 2 DS 2 -VASc score was 4.8±1.5, whereas the mean hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol (HAS-BLED) score was 3.0±1.1. Prior stroke or transient ischemic attack was reported in 40.2% and prior bleeding in 70.1%, with gastrointestinal bleeding being most common (41.9%). The most common site-reported procedural indications for Watchman implantation were increased thromboembolic risk (64.8%) and history of major bleed (64.3%), followed by high fall risk (35.5%). Most (71.9%) had ≥2 procedural indications. Patients with high fall risk had increased risk of in-hospital adverse events (adjusted OR, 1.12; P =0.025), but no other differences were found in the risk of in-hospital adverse events by procedural indication. Conclusions: Among patients in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry, the most common procedural indications for Watchman implantation were increased thromboembolic risk, history of major bleed, and high fall risk. A majority of patients had multiple procedural indications. High fall risk conferred a modestly increased risk of in-hospital adverse events.

Background: While concerns about the safety and procedural success of radial, as opposed to femoral, access for PCI have largely been abated, the association of radial access with patients’ health status recovery has not been explored. To address this gap in knowledge, we compared the symptoms, physical function and quality of life 1 year after PCI in patients treated with radial, as compared with femoral, access. Methods: This is a 10-center study of PCI, in whom 48 of 139 (35%) interventionalists used both radial and femoral approaches between 2009-2010. A total 2628 patients without prior CABG were interviewed and followed for one year. The previously validated Seattle Angina Questionnaire (SAQ) was used to assess disease-specific health status and the EQ-5D was used to quantify generic quality of life. Clinical characteristics and health status outcomes were compared between 296 radial and 2332 femoral PCI procedures. Results: Radial access was used in 11.2% of patients. No demographic (age, gender, race) or clinical factors (e.g. BMI, smoking, diabetes, hypertension, renal disease or prior cardiac history) were associated with radial use, except for an increased use among those with PAD (10.5% radial vs. 6.8% femoral, p=0.022) but reduced use among those with prior PCI (38.3% vs. 32.1%, p=0.037). There was no difference in health status outcomes based on SAQ angina frequency and quality of life, or the EQ-5D at baseline, 6 months or one year (table). Conclusion: In this multi-center observational registry, there was no association of radial access with long-term health status outcomes. These data suggest that there are no offsetting concerns about patients’ long-term health status benefits to counterbalance the peri-procedural safety benefits of a radial approach.

Background: Whether patients with STEMI with longer times from symptom onset to hospital presentation are less likely to be treated with any reperfusion therapy or treated with less urgency resulting in longer door-to-balloon and door-to-needle times is not known. The relationship between delay in hospital presentation and the quality of reperfusion therapy for patients with STEMI has not been examined Methods: We constructed 3 cohorts of STEMI patients to analyze use of any reperfusion (n=440,398), door-to-balloon time (n=67,207), and door-to-drug time (n=183,441) as a function of delay in hospital presentation. We constructed multivariable generalized linear models for each outcome to estimate the associations between delay in hospital presentation adjusted for all patient and hospital characteristics. Results: In adjusted analysis, longer times from symptom onset to hospital presentation was associated with lower use of any reperfusion therapy (p<0.0001 for trend). For early presenters with times of ≤1 hour, >1 to 2 hours, and >2 to 3 hours, 77%, 77%, and 73% of patients received any reperfusion therapy, respectively, and late presenters with times >9 to 10 hours, >10 to 11 hours, and >11 to 12 hours were treated with any reperfusion therapy in 53%, 50%, and 46%, respectively. Delay in hospital presentation was associated with longer drug-to-balloon and door-to-drug times (p<0.0001 for trend). For time intervals of ≤ 1 hour, >1 to 2 hours, >2 to 3 hours, >9 to 10 hours, >10 to 11 hours, and >11 to 12 hours, patients with STEMI were treated with door-to-balloon times of 99, 101, 106, 123, 125, and 123 minutes respectively. For delay time intervals of ≤ 1 hour, >1 to 2 hours, >2 to 3 hours, >9 to 10 hours, >10 to 11 hours, and >11 to 12 hours, patients were treated with door-to-drug times of 32, 34, 36, 46, 44, and 46 minutes, respectively. Conclusions: Longer time from symptom onset to hospital presentation has important implications for subsequent treatment and was associated with lower use of any reperfusion therapy and longer door-to-balloon and door-to-drug times. Longer delay in hospital presentation is associated with worse system performance for reperfusion therapy quality and represents an opportunity to improve quality of care for STEMI patients.

Current guidelines recommend cardiac resynchronization therapy (CRT-D) in appropriate patients undergoing ICD implantation. However, not all physicians who implant ICDs are trained to perform CRT-D. We examined the ICD Registry to assess whether use of CRT-D implantation varied by physician certification. We determined the certification of 2128 physicians who had submitted >=10 cases between April 2006 and June 2007. We excluded patients with a prior ICD, an epicardial lead, or aged ≤18 years, leaving 111,293 patients. Physicians were grouped into mutually exclusive categories reflecting highest current certification- Electrophysiology (EP), Cardiovascular Disease (CVD), Thoracic Surgery (TS), Internal Medicine (IM), Heart Rhythm Society alternative pathway (HRS), and Other. Patients were considered eligible for CRT-D if they met the following criteria: QRS duration >=120ms, LVEF ≪26>35%, and NYHA Class III-IV. We examined crude rates of CRT-D across physician categories and developed a logistic regression model to assess the association of physician certification and CRT-D implantation. Candidate variables included demographics, cardiac status, comorbidities, and physician volume. Odds ratios were converted to relative risks. 35,851 patients met all three eligibility criteria for CRT-D, and 28,932 (80.7%) had a CRT-D implanted. EP physicians implanted the majority of CRT-D (73.6%), with fewer CRT-D placed by CVD (20.6%), TS (0.9%), IM (0.8%), HRS (1.1%), or Other (3.1%). The crude rate of CRT-D implantation was highest among EP physicians and lower in all other categories: EP- 83.1%, CVD-75.8%, TS- 57.9%, IM- 76.5%, HRS- 77.1%, Other- 73.5% (p<0.001). In multivariable analysis, CVD and TS physicians were less likely to implant CRT-D in eligible patients compared with EP physicians (EP: Ref; CVD: RR 0.92 (0.90 – 0.94); TS: RR 0.76 (0.71– 0.85)). CRT-D rates were comparable for other physician groups (IM RR 0.95 (0.87–1.01); HRS: RR 0.97 (0.90 –1.02); Other RR 0.97 (0.93–1.00)). Among eligible patients, use of CRT-D varies by physician certification. Given the benefits of CRT-D, clinicians should consider referring eligible patients to physicians with familiarity and expertise in CRT-D implantation.

Introduction: The American College of Cardiology developed the National Cardiovascular Data Registry (NCDR) AFib Ablation Registry to assess prevalence, demographics, procedural management and outcomes of patients undergoing atrial fibrillation (AFib) ablation procedures. The objective of this registry’s first presentation is to summarize initial AFib Ablation Registry data regarding patient characteristics, procedural characteristics, and in-hospital adverse events and outcomes in those undergoing AFib ablation enrolled in the registry. Methods: Data were tabulated and summarized with simple proportions for categorical data, and mean ± standard deviation for continuous data. Results: A total of 31,345 patients who underwent AFib ablation were included in the registry (mean age 65.0 ± 10.4, 65.2% male, 57.6% paroxysmal AFib), with ablations performed at 120 hospitals, by 501 physicians. The mean CHA2DS2-VASc score of was 2.6 ± 1.6, and mean HAS-BLED score was 1.1 ± 0.9. Successful pulmonary vein isolation was able to be achieved in all veins in 94.5% of patients. The prevalence of any complication during procedural admission was 3.1%; the most common were hematoma (0.5%) and pericardial effusion requiring intervention (0.42%). The mean length of stay during the index admission (days) was 1.4 ± 7.6, and in-hospital death prevalence was 0.04% [FIGURE] . Conclusions: In conclusion, the NCDR AFib Ablation Registry is a large, national, multi-center, prospective cohort study to describe events outside the clinical trial or research setting, demonstrating successful pulmonary vein isolation in the majority of patients and a low prevalence of adverse events. Future studies from the registry will be able to help support and develop evidence-based guidelines for AFib ablation treatment and optimize patient outcomes.