Publications

BACKGROUND: Catheter ablation is an effective therapy for ventricular tachycardia (VT) and is increasing in use. Assessment of contemporary real-world outcomes of VT ablation requires data inclusive of both inpatient and outpatient encounters.

OBJECTIVE: We aimed to assess factors associated with 1-year in-hospital mortality, all-cause readmission, and recurrent readmission for VT after VT ablation along with the associated costs of care.

METHODS: Inpatient and outpatient VT ablations were captured in the Healthcare Cost and Utilization Project data in Florida, Maryland, and New York from 2016 to 2020 with 1-year follow-up through 2021. Cox proportional hazards regression was used to identify risk factors associated with 1-year in-hospital mortality, all-cause readmission, and recurrent VT readmission. Costs of inpatient cases and readmission were captured.

RESULTS: Of 3899 patients undergoing VT ablation, 2% died during the initial episode of care. The 1-year in-hospital mortality rate, all-cause readmission rate, and recurrent VT readmission rate were 6.8%, 43.4%, and 16.9%, respectively, and were broadly stable during the study period. Coronary artery disease, chronic kidney disease, and heart failure were independently associated with an increased risk of in-hospital mortality and all-cause readmission within 1 year (P < .05). Recurrent VT was the most common cause of readmission. All-cause readmissions increased costs by 55%.

CONCLUSION: Mortality, long-term readmission, and recurrent VT remain high after VT ablation and include measurably important costs. Strategies to improve freedom from recurrent VT while managing comorbid conditions may serve as targets for improving the efficacy and cost-effectiveness of an important procedure applied to a vulnerable population.

BACKGROUND: Despite reported racial disparities between Black and White adults in short-term outcomes after abdominal aortic aneurysmal intervention, there is a paucity of literature aimed at understanding long-term disparities. The present study aims to characterize racial disparities in long-term outcomes, perioperative outcomes, and health care use after endovascular aortic aneurysm repair.

METHODS: We conducted a retrospective cohort study from 2011 to 2019 with outcome assessment through 2020. Using a 100% sample of national Medicare data, we identified beneficiaries ≥66 years of age who underwent intact infrarenal endovascular aortic aneurysm repair. The primary outcome was a composite of endovascular or open aortic reintervention, late aneurysm rupture, and all-cause mortality. Secondary outcomes included other reinterventions, perioperative outcomes, and annual rates of health care use.

RESULTS: A cohort of 107 636 Black (3.9%) and White (96.1%) beneficiaries was identified. The cumulative incidence of the primary outcome was 72.9% (95% CI, 71.8%-73.9%) in White patients versus 80.0% (95% CI, 76.4-83.0) in Black patients (P<0.0001). The adjusted hazard of the primary outcome was not significantly different between Black and White adults (adjusted hazard ratio [HR] 1.04 [95% CI, 0.99-1.09]); however, when death was treated as a competing risk, a significantly higher hazard for the composite outcome was observed for Black patients (subdistribution HR, 1.56 [95% CI, 1.39-1.76]). Components of the primary outcome were also greater among Black compared with White patients. Black patients had higher rates of medical complications in the perioperative period, including acute renal failure (subdistribution HR, 1.18 [95% CI, 1.01-1.38]), dialysis initiation (subdistribution HR, 2.75 [95% CI, 2.03-3.7]), and deep vein thrombosis (subdistribution HR, 1.54 [95% CI, 1.05-2.26]). Black patients had lower rates of vascular office visits after intervention (adjusted rate ratio, 0.96 [95% CI, 0.93-0.99]) but higher rates of emergency department visits (adjusted rate ratio, 1.05 [95% CI, 1.02-1.09]) and hospital readmissions (adjusted rate ratio, 1.13 [95% CI, 1.08-1.18]).

CONCLUSIONS: Black patients demonstrated increased risk of late aortic-related events after endovascular aortic aneurysm repair after accounting for the competing risk of death and controlling for baseline covariates. Further investigation into structural barriers affecting optimal preoperative medical management and barriers to postoperative health care access is necessary to further elucidate underlying mechanisms for the observed disparities.

Although transcatheter aortic valve replacement (TAVR) devices can impair coronary access, there are limited real-world data comparing outcomes of percutaneous coronary intervention (PCI) in post-TAVR versus non-TAVR patients. In this study, we compare procedural characteristics and outcomes between patients with versus without a history of TAVR who undergo PCI. We used claims data for the Medicare population to evaluate the incidence of PCI after TAVR between 2011 and 2017. Then, using the CathPCI Registry, we compared PCI outcomes between patients with a history of TAVR versus propensity score-matched non-TAVR patients. Of the 52,780 Medicare patients who underwent TAVR between 2011 and 2017, the incidence of acute myocardial infarction (AMI) was 10.2% and of PCI was 5.1% at 5 years. At 5 years, the incidence of stroke was 5.0% and of death was 64.0%. In the CathPCI Registry, procedural success for PCI was similar between 1,309 post-TAVR patients versus 5,236 propensity-score matched patients without prior TAVR. However, post-TAVR patients required greater fluoroscopic time (21.9 vs 17.7 minutes, p <0.001) and had higher rates of post-procedural stroke (0.8% vs 0.4%, p = 0.02) and bleeding (5.1% vs 2.9%, p <0.001). Post-TAVR patients were more likely to have repeat PCI in the 3 years post-PCI (HR: 1.36, 95% C.I: 1.09, 1.70) and had higher rates of stroke (HR: 1.65, C.I.: 1.07 to 2.56, p = 0.023) and death (HR: 1.23, C.I.: 1.11-1.38, p <0.001) compared to non-TAVR patients. In conclusion, in the CathPCI Registry, patients with a history of TAVR appeared to have similar procedural success but longer fluoroscopic times, more frequent post-procedural bleeding and stroke, and a higher likelihood of a repeat PCI compared with matched patients without a history of TAVR.

IMPORTANCE: Percutaneous coronary intervention (PCI) is the criterion standard for acute ST-elevation myocardial infarction (STEMI). Achieving target first medical contact (FMC)-to-device time is a quality metric in STEMI care.

OBJECTIVES: To describe site-level variability in achieving target FMC-to-device time (≤90 minutes for primary presentations to PCI-capable hospitals and ≤120 minutes for transfers), compare treatment times according to hospital performance, location, and primary PCI volume, and assess whether these aspects are associated with clinical outcomes.

DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective cross-sectional study from the American Heart Association Get With the Guidelines-Coronary Artery Disease registry from 2020 to 2022. Patients were recruited from a multicenter quality-improvement registry across 503 US hospitals. Patients with STEMI or STEMI equivalent who underwent primary PCI were included in this analysis.

EXPOSURES: FMC-to-device time.

MAIN OUTCOMES AND MEASURES: Hospital performance was determined by the proportion of patients meeting target FMC-to-device time at each site. Treatment times and outcomes were compared by hospital performance, location, and primary PCI volume.

RESULTS: A total of 73 826 patients were analyzed (median [IQR] age, 62 [54-71] years; 53 474 male [72.4%]). Of 60 109 patients who presented directly to PCI-capable hospitals (primary presentations), 35 783 (59.5%) achieved an FMC-to-device time of 90 minutes or less, whereas 6900 (50.3%) of 13 717 transfers had an FMC-to-device time of 120 minutes or less. There was substantial institutional variability in achieving target FMC-to-device time for both primary presentations (median [IQR], 60.8% [51.2%-68.8%]) and transfers (median [IQR], 50.0% [32.5%-66.9%]). High-performing centers met all target treatment times more frequently. Low-performing sites experienced prolonged emergency department stays, catheterization laboratory arrival-to-PCI times, and transfer delays, varying by mode of presentation. Compared with urban centers, presentation to rural hospitals did not affect the odds of meeting target FMC-to-device time for primary presentations (adjusted odds ratio [aOR], 1.20; 95% CI, 0.96-1.50) or transfers (aOR, 0.86; 95% CI, 0.50-1.47). Failure to achieve target FMC-to-device time was associated with increased in-hospital mortality risk for primary presentations (aOR, 2.21; 95% CI, 2.02-2.42) and transfers (aOR, 2.44; 95% CI, 1.90-3.12). Low hospital performance was associated with increased mortality risk compared with high performance in primary presentations (aOR, 1.16; 95% CI, 1.00-1.34). Outcomes were similar between rural vs urban and low vs high primary PCI volume centers.

CONCLUSIONS AND RELEVANCE: In this large cross-sectional study of patients with STEMI, there was substantial hospital-level variability in achieving target treatment times. Patients in whom target FMC-to-device time was not met and those presenting to low-performing hospitals had worse outcomes.

BACKGROUND AND AIMS: Radial access site for percutaneous coronary intervention (PCI) is recommended by clinical practice guidelines because of superior outcomes compared with femoral access site. Historically, the adoption of radial access site in the USA has lagged behind much of the rest of the world, but contemporary data on access site selection across the spectrum of clinical presentations and its association with outcomes are lacking.

METHODS: A retrospective cohort study from the National Cardiovascular Data Registry's CathPCI Registry was conducted including PCIs performed between 1 January 2013 and 30 June 2022. The comparative safety of radial vs femoral access site for PCI was evaluated with instrumental variable analysis, a technique that can be used to support causal inference, exploiting operator variation in access site preferences as the instrumental variable.

RESULTS: Overall, 6 658 479 PCI procedures were performed during the study period, of which 40.4% (n = 2 690 355) were performed via radial access site, increasing from 20.3% in 2013 to 57.5% in 2022. This increase was seen in all geographic regions and across the full spectrum of presentations, with the largest relative increase seen in patients with ST-elevation myocardial infarction. Overall, 2 420 805 PCIs met inclusion criteria for the comparative safety analysis. In instrumental variable analyses, radial access site was associated with lower in-hospital mortality [absolute risk difference (ARD) -.15%, 95% confidence interval (CI) -.20 to -.10], major access site bleeding (ARD -.64%, 95% CI -.68 to -.60), and other major vascular complications (ARD -.21%, 95% CI -.23 to -.18) but a higher risk of ischaemic stroke (ARD .05%, 95% CI .03-.08). There was no association with the falsification endpoint of gastrointestinal or genitourinary bleeding (ARD .00%, 95% CI -.03-.03).

CONCLUSIONS: Over the past decade, use of radial access site for PCI has increased 2.8-fold in the USA and now represents the dominant form of access site across all procedural indications. Based on instrumental variable analyses, PCI with radial access site had lower rates of in-hospital mortality, major access site bleeding, and other major vascular complications compared with femoral access site but a slightly higher risk of ischaemic stroke in contemporary practice.

BACKGROUND: Claims data are increasingly used for postmarketing surveillance of therapies such as transcatheter left atrial appendage occlusion (LAAO), but their accuracy remains uncertain.

OBJECTIVES: This study aimed to compare stroke and bleeding events in the National Cardiovascular Data Registry LAAO Registry with claims data.

METHODS: LAAO Registry data for patients aged ≥65 years were linked to 2016 to 2021 Medicare claims. Primary diagnosis International Classification of Diseases-Tenth Revision codes from inpatient hospitalizations were compared to adjudicated registry-reported stroke and major bleeding events after discharge, including estimation of sensitivity and positive predictive value of claims for identifying registry-reported events. Kappa statistics and incidence rates were also assessed.

RESULTS: Among 71,043 LAAO Registry patients, sensitivity and positive predictive value of claims were 60.8% and 50.5% for ischemic stroke (kappa 0.55), 42.7% and 50.5% for hemorrhagic stroke (kappa 0.46), 55.9% and 40.3% for gastrointestinal bleeding (GIB) (kappa 0.43), 62.2% and 38.0% for intracranial hemorrhage (kappa 0.47), and 20.4% and 10.0% for other major bleeding (kappa 0.12). Sensitivity and negative predictive values were >92% for all events. Two-year incidence rates were higher in claims vs registry data for ischemic stroke (2.5% vs 2.2%), GIB (6.8% vs 5.2%), intracranial hemorrhage (1.6% vs 1.1%), and other bleeding (3.1% vs 1.5%; P < 0.01 for all events), and lower for hemorrhagic stroke (0.4% vs 0.5%; P = 0.03).

CONCLUSIONS: In the LAAO Registry, International Classification of Diseases-Tenth Revision codes have moderate agreement with stroke, GIB, and intracranial hemorrhage, and overestimate most event rates compared to adjudicated registry-reported events. Nonclaims-based methods are needed to ensure accurate assessment of clinical events in postmarketing surveillance.

Wire-based indices of coronary physiology are the gold standard for guiding revascularisation decisions in patients with coronary artery disease and angiographically intermediate coronary stenoses. FFRangio is a novel angiography-based technology for assessing the functional significance of epicardial coronary stenoses without pressure wires or hyperaemic stimulus. The primary objective of the Advancing Cath Lab Results with FFRangio Coronary Physiology Assessment trial (ALL-RISE; ClinicalTrials.gov: NCT05893498) is to compare clinical outcomes in patients with chronic coronary syndromes or non-ST-segment elevation acute coronary syndromes undergoing coronary angiography with ≥1 coronary lesion suitable for physiological assessment. Patients will be randomised to FFRangio-guided or to pressure wire-guided treatment. The primary endpoint is the occurrence of major adverse cardiovascular events (MACE) at 1 year (a composite of all-cause death, myocardial infarction, or unplanned clinically driven revascularisation), assessed for non-inferiority of FFRangio-based versus pressure wire-based guidance. If non-inferiority is met, reflex superiority guidance will be tested. Secondary endpoints include periprocedural and early complications up to 30 days, individual components of MACE at 1 year, patient-reported health status, procedural resource utilisation and healthcare-related costs, and operator-assessed usability of the FFRangio and pressure wire systems. With a sample size of 1,924 patients, the study has 82.7% power to assess non-inferiority with a non-inferiority margin of 3.5%. The ALL-RISE trial will provide prospective clinical outcomes data on the relative safety, efficacy, and cost-effectiveness of a workflow using FFRangio as compared with pressure wire-based approaches for coronary lesion assessment among patients being considered for percutaneous coronary intervention.

BACKGROUND: Patients with coronary in-stent restenosis (ISR) within multiple layers of stent pose a specific clinical challenge because of higher rates of recurrent restenosis as well as a desire to avoid an additional layer of stent. Drug-coated balloons (DCBs) provide an alternative antiproliferative therapeutic option for multilayer ISR.

OBJECTIVES: We evaluated the efficacy and safety of a low-dose paclitaxel-coated vs uncoated balloon among patients with multilayer or single-layer ISR in the AGENT IDE (A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis) trial.

METHODS: AGENT IDE is a prospective, multicenter trial that randomized patients with ISR (reference vessel diameter >2.0 mm to ≤4.0 mm and lesion length <26 mm) in a 2:1 allocation to paclitaxel-coated or an uncoated balloon following successful lesion preparation. Randomization was stratified by multi- vs single-layer ISR as well as by center. The primary study endpoint was 1-year target lesion failure (TLF): composite occurrence of ischemia-driven target lesion revascularization (TLR), target vessel-related myocardial infarction (MI), or cardiac death.

RESULTS: Of the 600 patients randomized in the trial, multilayer ISR was present in 258 (44%) patients. Patients with multilayer ISR had higher rates of TLF at 1 year compared with those with single-layer ISR (29.0% vs 15.7%, P < 0.0001). The overall study results were consistent irrespective of multilayer vs single-layer ISR (Pinteraction = 0.66). Among patients with multilayer ISR, TLF was lower with paclitaxel-coated balloon compared with an uncoated balloon (23.8% vs 40.0%; HR: 0.55; 95% CI: 0.34-0.87; P = 0.01), driven by reductions in both TLR and target vessel-related MI. Similar findings were observed among patients with single layer ISR (1-year TLF: 13.5% with paclitaxel-coated vs 20.2% with uncoated balloon; HR: 0.64; 95% CI: 0.37-1.11; P = 0.11), although absolute event rates were lower.

CONCLUSIONS: Patients with ISR of multiple stent layers had higher rates of adverse stent-related events compared with patients with single-layer ISR. Treatment with a paclitaxel-coated balloon led to greater absolute risk reduction in 1-year TLF among patients with multilayer ISR compared with an uncoated balloon. (A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis [ISR] [AGENT IDE]; NCT04647253).

OBJECTIVE: Chronic limb-threatening ischemia (CLTI), the most severe manifestation of peripheral artery disease, is associated with high risk of major amputation and mortality. Although timely revascularization is a cornerstone of CLTI management, disparities in access to care and outcomes persist across U.S. geographic regions. This study aims to evaluate variations in endovascular revascularization for CLTI, health care utilization patterns, and outcomes stratified by U.S. regions to inform how we address these disparities.

METHODS: From 2016 through 2023, all endovascular revascularizations for CLTI among Medicare fee-for-service beneficiaries were included and evaluated by Northeast, South, Midwest, and West regions of the United States. Follow-up continued through December 31, 2023, with a median duration of 625 days (maximum 2921 days). The primary outcome was a composite of death or major amputation. Secondary outcomes included major amputation, all-cause mortality, repeat revascularization, change in ambulatory status, and health care utilization before and after revascularization. Multivariable Cox proportional hazards regression models were used to adjust for demographic, clinical, and procedural characteristics.

RESULTS: Among 381,173 beneficiaries, the South performed more than half of all revascularizations throughout the study period (52.18%), followed by the West (17.3%), Northeast (16.2%), and the Midwest (13.9%). After adjustment, the Midwest showed the highest risk for the primary outcome (hazard ratio [HR]: 1.20; 95% confidence interval [CI]: 1.18, 1.22; P < .0001), followed by the South (HR: 1.11; 95% CI: 1.10, 1.13; P < .0001) and West (HR: 1.04; 95% CI: 1.02, 1.06; P < .0001), all compared with the Northeast. Health care utilization analyses revealed fewer outpatient visits with a vascular provider before and after revascularization in all regions compared with the Northeast with the lowest rates in the Midwest (before revascularization: adjusted rate ratio: 0.73; 95% CI: 0.72, 0.74; P < .0001; after revascularization: adjusted rate ratio: 0.73; 95% CI: 0.72, 0.74; P < .0001).

CONCLUSIONS: Disparities in access to care and outcomes persist across U.S. regions for Medicare beneficiaries with CLTI and influence health care utilization and outcomes. The Midwest region, in particular, that cares for a high proportion of rural patients experiences the greatest risks of amputation and death related to CLTI, which may in part be due to less frequent health care contact after revascularization. Targeted improvements in health care access, especially in rural and economically disadvantaged regions, are needed to enhance outcomes in patients with CLTI.