Comorbidity Differences Associated with Long-Term Amputation and Repeat Revascularization Rates after Femoropopliteal Artery Intervention for Intermittent Claudication by Sex, Race, and Ethnicity.

BACKGROUND: Use of peripheral vascular intervention (PVI) for intermittent claudication (IC) continues to expand, but there is uncertainty whether baseline demographics, procedural techniques and outcomes differ by sex, race, and ethnicity. OBJECTIVES: Examine amputation and revascularization rates up to 4 years after FP PVI for IC by sex, race, and ethnicity. METHODS: Patients undergoing FP PVI for IC during 2016-2020 from the PINC AITM Healthcare Database were analyzed. The primary outcome was any index limb amputation (ILA), assessed by Kaplan-Meier estimate. Secondary outcomes included index limb major amputation, repeat revascularization, and index limb repeat revascularization. Unadjusted and adjusted hazard ratios (HR) were estimated using Cox proportional hazard regression models. RESULTS: This study included 19,324 patients with IC who underwent FP PVI with 41.2% women, 15.6% Black patients, and 4.7% Hispanic patients. Women were less likely than men to be treated with atherectomy (45.1% vs. 47.8%, p=0.0003), Black patients were more likely than White patients to receive atherectomy (50.7% vs. 44.9%, p<0.001), and Hispanic patients were less likely to receive atherectomy than non-Hispanic patients (41% vs. 47%, p=0.0004). Unadjusted rates of any amputation were similar between men and women (6.4% for each group, logrank p=0.842), higher among Black patients than. White patients (7.8% vs. 6.1%, logrank p = 0.007) and higher among Hispanic patients than non-Hispanic patients (8.8% vs. 6.3%, logrank p=0.031). After adjustment for baseline characteristics, Black race was associated with higher rates of repeat revascularization (adjusted HR=1.13; 95% CI:1.04, 1.22) and any femoropopliteal revascularization (adjusted HR=1.10; 95% CI:1.01,1.20). No statistical difference in amputation rate was observed between comparison groups. CONCLUSION: Women and men with intermittent claudication had similar crude and adjusted amputation and revascularization outcomes after FP PVI. Black patients had higher repeat revascularization and any FP revascularization rates than White patients. Black and Hispanic patients had higher crude amputation rates, but these differences were attenuated by adjustment for baseline characteristics. Black patients were more likely to receive atherectomy and had higher rates of any repeat revascularization and specifically FP revascularization. Further study is necessary to determine whether these patterns are related to disease-specific issues or practice-pattern differences between different populations.

Real-World Experience and Outcomes With Percutaneous Coronary Intervention for Protected Versus Unprotected Left Main Coronary Artery Disease: Insights from the Veteran Affairs Clinical Assessment Reporting and Tracking Program.

The practice patterns and outcomes of protected left main (PLM) and unprotected left main (ULM) percutaneous coronary intervention (PCI) are not well defined in contemporary US clinical practice. Data were collected from all Veteran Affairs catheterization laboratories participating in the Clinical Assessment Reporting and Tracking Program between 2009 and 2019. The analysis included 4,351 patients who underwent left main PCI, of whom 1,306 pairs of PLM and ULM PCI were included in a propensity-matched cohort. Selected temporal trends were also assessed. The primary outcome was major adverse cardiovascular event (MACE) outcomes at 1 year, which was defined as a composite of all-cause mortality, rehospitalization for myocardial infarction (MI), rehospitalization for stroke, or urgent revascularization. Patients who underwent ULM PCI compared with patients who underwent PLM PCI were older (age 71.5 vs 69.2 years, p <0.001), more clinically complex, and more likely to present with acute coronary syndrome. In the propensity-matched cohort, radial access was used more often for ULM PCI (21% [273] vs 14% [185], p <0.001) and ULM PCI was more likely to involve the left main bifurcation (22% vs 14%, p = 0.003) and require mechanical circulatory support (10% [134] vs 1% [17], p <0.001). The 1-year MACEs occurred more frequently with ULM PCI than PLM PCI (22% [289] vs 16% [215], p ≤0.001) and all-cause mortality was also higher (16% [213] vs 10% [125], p ≤0.001). In the matched cohort, there was a low incidence of rehospitalization for MI (4% [48] ULM vs 4% [48] PLM, p = 1.000) or revascularization (7% [94] ULM vs 6% [84] PLM, p = 0.485). In this real-world experience, patients who underwent PLM PCI had better 1-year outcomes than those who underwent ULM PCI; however, in both groups, there was a high rate of mortality and MACEs at 1 year despite a relatively low rate of MI or revascularization.

Predicting Major Adverse Events in Patients Undergoing Transcatheter Left Atrial Appendage Occlusion.

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.

Outcomes of Percutaneous Coronary Intervention for Protected versus Unprotected Left Main Coronary Artery Disease: Insights from the VA CART Program.

Background: Practice patterns and outcomes of protected left main (PLM) and unprotected left main (ULM) percutaneous coronary intervention (PCI), as well as the differences between these types of PCI, are not well defined in real-world clinical practice. Methods: Data collected from all Veteran Affairs (VA) catheterization laboratories participating in the Clinical Assessment Reporting and Tracking Program between 2009 and 2019. The analysis included 4,351 patients undergoing left main PCI, of which 1,306 pairs of PLM and ULM PCI were included in a propensity matched cohort. Patients and procedural characteristics were compared between PLM and ULM PCI. Temporal trends were also assessed. Peri-procedural and one-year major adverse cardiovascular events (MACE) were compared using cumulative incidence plots. The primary outcome was MACE outcomes at 1-year, which was defined as a composite of all-cause mortality, rehospitalization for myocardial infarction (MI), rehospitalization for stroke or urgent revascularization. Results: ULM PCI patients in comparison to PLM PCI were older (71.5 vs 69.2; P < 0.001), more clinically complex and more likely to present with ACS. In the propensity matched cohort, radial access was used more often for ULM PCI (21% [273] vs. 14% [185], P < 0.001), and ULM PCI was more likely to involve the LM bifurcation (22% vs 14%; P = 0.003) and require mechanical circulatory support (10% [134] vs 1% [17]; P <0.001). One-year MACE occurred more frequently with ULM PCI compared to PLM PCI (22% [289] vs. 16% [215]; P = < 0.001) and all-cause mortality was also higher (16% [213] vs. 10% [125]; P = < 0.001). In the matched cohort there was a low incidence of rehospitalization for MI (4% [48] ULM vs. 4% [48] PLM; P = 1.000) or revascularization (7% [94] ULM vs. 6% [84] PLM; P = 0.485). Conclusions: Veterans undergoing PLM PCI had better one-year outcomes than those undergoing ULM PCI, but in both groups there was a high rate of mortality and MACE at one-year despite a relatively low rate of MI or revascularization.

Contemporary Methods for Predicting Acute Kidney Injury After Coronary Intervention.

BACKGROUND: Acute kidney injury (AKI) is the most common complication after percutaneous coronary intervention (PCI). Accurately estimating patients' risks not only creates a means of benchmarking performance but can also be used prospectively to inform practice. OBJECTIVES: The authors sought to update the 2014 National Cardiovascular Data Registry (NCDR) AKI risk model to provide contemporary estimates of AKI risk after PCI to further improve care. METHODS: Using the NCDR CathPCI Registry, we identified all 2020 PCIs, excluding those on dialysis or lacking postprocedural creatinine. The cohort was randomly split into a 70% derivation cohort and a 30% validation cohort, and logistic regression models were built to predict AKI (an absolute increase of 0.3 mg/dL in creatinine or a 50% increase from preprocedure baseline) and AKI requiring dialysis. Bedside risk scores were created to facilitate prospective use in clinical care, along with threshold contrast doses to reduce AKI. We tested model calibration and discrimination in the validation cohort. RESULTS: Among 455,806 PCI procedures, the median age was 67 years (IQR: 58.0-75.0 years), 68.8% were men, and 86.8% were White. The incidence of AKI and new dialysis was 7.2% and 0.7%, respectively. Baseline renal function and variables associated with clinical instability were the strongest predictors of AKI. The final AKI model included 13 variables, with a C-statistic of 0.798 and excellent calibration (intercept = -0.03 and slope = 0.97) in the validation cohort. CONCLUSIONS: The updated NCDR AKI risk model further refines AKI prediction after PCI, facilitating enhanced clinical care, benchmarking, and quality improvement.

Complex Percutaneous Coronary Intervention Outcomes in Older Adults.

Background Complex percutaneous coronary intervention (PCI) is increasingly performed in older adults (age ≥75 years) with stable ischemic heart disease. However, little is known about clinical outcomes. Methods and Results We derived a cohort of older adults undergoing elective PCI for stable ischemic heart disease across a large health system. We compared 12-month event-free survival (freedom from all-cause death, nonfatal myocardial infarction, stroke, and major bleeding), all-cause death, target lesion revascularization, and bleeding events for patients receiving complex versus noncomplex PCI and derived risk estimates with Cox regression models. We included 513 patients (mean age, 81±5 years). Patients receiving complex PCI versus noncomplex PCI did not significantly differ across a host of clinical characteristics including cardiovascular disease features, noncardiac comorbidities, guideline-directed medical therapy use, and frailty. Patients receiving complex PCI versus noncomplex PCI experienced worse event-free survival (80.4% versus 86.8%), which was not significant in adjusted analyses (hazard ratio [HR], 1.38 [95% CI, 0.88-2.16]). All-cause death at 1 year for patients undergoing complex PCI was nearly double that seen for patients receiving noncomplex PCI (10.2% versus 5.9%), and the risk was significant in models adjusted for clinical characteristics (HR, 1.97 [95% CI, 1.02-3.79]). Target lesion revascularization risk was lower for patients receiving complex PCI (2.2% versus 3.5%, adjusted HR), but bleeding events were not statistically different between groups (25.3% versus 20.5%; P=0.19). Conclusions Complex PCI in older adults with stable ischemic heart disease was associated with lower risk of target lesion revascularization but higher all-cause death compared with noncomplex PCI.

Left ventricular lead implantation failure in an unselected nationwide cohort.

BACKGROUND: Left ventricular (LV) lead implantation is often the most challenging aspect of cardiac resynchronization therapy (CRT) procedures; early studies reported implant failure rates in ∼10% of cases. OBJECTIVE: The purpose of this study was to define rates, reasons for, and factors independently associated with LV lead implant failure. METHODS: We studied patients with left bundle branch block and ejection fraction ≤ 35% who underwent planned de novo transvenous CRT implantation (2010-2016) and were reported to the National Cardiovascular Data Registry ICD Registry. Independent predictors of LV lead implant failure were determined using logistic regression; age, sex, and variables with a univariable P value of <.15 were considered for inclusion in the model. RESULTS: Of the 111,802 patients who underwent a planned CRT procedure, 3.6% of patients (n = 3979) had LV lead implant failure. Reasons for implant failure included venous access (7.5%), coronary sinus access (64.3%), tributary vein access (13.5%), coronary sinus dissection (7.6%), unacceptable threshold (4.4%), and diaphragmatic stimulation (1.7%). Significant independent predictors of LV lead implant failure included younger age (odds ratio [OR] 1.01; 95% confidence interval [CI] 0.1.01-1.02), female sex (OR 1.38; 95% CI 1.29-1.47), black race (vs white, OR 1.44; 95% CI 1.32-1.57), Hispanic ethnicity (OR 1.23; 95% CI 1.08-1.40), QRS duration (OR 1.055 per 10 ms; 95% CI 1.038-1.072 per 10 ms), obstructive sleep apnea (OR 1.14; 95% CI 1.04-1.24), and implantation by a physician without specialized training (vs electrophysiology trained, OR 1.53; 95% CI 1.34-1.76). CONCLUSION: LV lead implant failure is uncommon in the current era and is most commonly due to coronary sinus access failure. Predictors of LV lead implant failure included younger age, female sex, black race, Hispanic ethnicity, increased QRS duration, sleep apnea, and absence of electrophysiology training.

Association Between Claims-Defined Frailty and Outcomes Following 30 Versus 12 Months of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention: Findings From the EXTEND-DAPT Study.

Background Frailty is rarely assessed in clinical trials of patients who receive dual antiplatelet therapy (DAPT) after percutaneous coronary intervention. This study investigated whether frailty defined using claims data is associated with outcomes following percutaneous coronary intervention, and if there is a differential association in patients receiving standard versus extended duration DAPT. Methods and Results Patients ≥65 years of age in the DAPT (Dual Antiplatelet Therapy) Study, a randomized trial comparing 30 versus 12 months of DAPT following percutaneous coronary intervention, had data linked to Medicare claims (n=1326), and a previously validated claims-based index was used to define frailty. Net adverse clinical events, a composite of all-cause mortality, myocardial infarction, stroke, and major bleeding, were compared between frail and nonfrail patients. Patients defined as frail using claims data (12.0% of the cohort) had higher incidence of net adverse clinical events (23.1%) compared with nonfrail patients (10.7%; P<0.001) at 18-month follow-up and increased risk after multivariable adjustment (adjusted hazard ratio [HR], 2.24 [95% CI, 1.38-3.63]). There were no differences in effects of extended duration DAPT on net adverse clinical events for frail (HR, 1.42 [95% CI, 0.73-2.75]) and nonfrail patients (HR, 1.18 [95% CI, 0.83-1.68]; interaction P=0.61), although analyses were underpowered. Bleeding was highest among frail patients who received extended duration DAPT. Conclusions Among older patients in the DAPT Study, claims-defined frailty was associated with higher net adverse clinical events. Effects of extended duration DAPT were not different for frail patients, although comparisons were underpowered. Further investigation of how frailty influences ischemic and bleeding risks with DAPT are warranted. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00977938.

Long-Term Patient Outcomes After Femoropopliteal Peripheral Vascular Intervention in Patients With Intermittent Claudication.

BACKGROUND: In patients with intermittent claudication (IC), short-term amputation rates from clinical trial data following lower extremity femoropopliteal (FP) peripheral vascular intervention (PVI) are <1% with unknown longer-term rates. OBJECTIVES: The aim of this study was to identify revascularization and amputation rates following PVI in the FP segment and to assess 4-year amputation and revascularization rates after FP PVI for IC. METHODS: From 2016 to 2020, 19,324 patients undergoing FP PVI for IC were included from the PINC AI Healthcare Database and evaluated by treatment level (superficial femoral artery [SFA], popliteal artery [POP], or both). The primary outcome was index limb amputation (ILA) assessed by Kaplan-Meier estimate. The secondary outcomes were index limb major amputation and repeat revascularization. HRs were estimated using Cox proportional hazard regression. RESULTS: The 4-year index limb amputation rate following FP PVI was 4.3% (95% CI: 4.0-4.7), with a major amputation rate of 3.2% (95% CI: 2.9-3.5). After POP PVI, ILA was significantly higher than SFA alone (7.5% vs 3.4%) or both segment PVI (5.5%). In multivariate analysis, POP PVI was associated with higher ILA rates at 4 years compared with isolated SFA PVI (HR: 2.10; 95% CI: 1.52-2.91) and index limb major amputation (HR: 1.98; 95% CI: 1.32-2.95). Repeat FP revascularization rates were 15.2%; they were highest in patients undergoing both SFA and POP PVI (18.7%; P < 0.0001) compared with SFA (13.9%) and POP (17.1%) only. CONCLUSIONS: IC patients undergoing FP PVI had 4-year rates of index limb repeat revascularization of 16.7% and ILA rates of 4.3%. Further risk factors for amputation requires further investigation.

Racial Differences in Presentation and Outcomes After Peripheral Arterial Interventions: Insights From the NCDR-PVI Registry.

BACKGROUND: We assess the rates of device use and outcomes by race among patients undergoing lower extremity peripheral arterial intervention using the American College of Cardiology National Cardiovascular Data Registry-Peripheral Vascular Intervention (PVI) registry. METHODS: Patients who underwent PVI between April 2014 and March 2019 were included. Socioeconomic status was evaluated using the Distressed Community Index score for patients' zip codes. Multivariable logistic regression was used to assess factors associated with utilization of drug-eluting technologies, intravascular imaging, and atherectomy. Among patients with Centers for Medicare and Medicaid Services data, we compared 1-year mortality, rates of amputation, and repeat revascularizations. RESULTS: Of 63 150 study cases, 55 719 (88.2%) were performed in White patients and 7431 (11.8%) in Black patients. Black patients were younger (67.9 versus 70.0 years), had higher rates of hypertension (94.4% versus 89.5%), diabetes (63.0% versus 46.2%), less likely to be able to walk 200 m (29.1% versus 24.8%), and higher Distressed Community Index scores (65.1 versus 50.6). Black patients were provided drug-eluting technologies at a higher rate (adjusted odds ratio, 1.14 [95% CI, 1.06-1.23]) with no difference in atherectomy (adjusted odds ratio, 0.98 [95% CI, 0.91-1.05]) or intravascular imaging (adjusted odds ratio, 1.03 [95% CI, 0.88-1.22]) use. Black patients experienced a lower rate of acute kidney injury (adjusted odds ratio, 0.79 [95% CI, 0.72-0.88]). In Centers for Medicare and Medicaid Services-linked analyses of 7429 cases (11.8%), Black patients were significantly less likely to have surgical (adjusted hazard ratio, 0.40 [95% CI, 0.17-0.96]) or repeat PVI revascularization (adjusted hazard ratio, 0.42 [95% CI, 0.30-0.59]) at 1 year compared with White patients. There was no difference in mortality (adjusted hazard ratio [0.8-1.4]) or major amputation (adjusted hazard ratio, 2.5 [95% CI, 0.8-7.6]) between Black and White patients. CONCLUSIONS: Black patients presenting for PVI were younger, had higher prevalence of comorbidities and lower socioeconomic status. After adjustment, Black patients were less likely to have surgical or repeat PVI revascularization after the index PVI procedure.

In-hospital complications associated with pulmonary vein isolation with adjunctive lesions: the NCDR AFib Ablation Registry.

AIMS: No prior study has been adequately powered to evaluate real-world safety outcomes in those receiving adjunctive ablation lesions beyond pulmonary vein isolation (PVI). We sought to evaluate characteristics and in-hospital complications among patients undergoing PVI with and without adjunctive lesions. METHODS AND RESULTS: Patients in the National Cardiovascular Data Registry AFib Ablation Registry undergoing first-time atrial fibrillation (AF) ablation between 2016 and 2020 were identified and stratified into paroxysmal (PAF) and persistent AF, and separated into PVI only, PVI + cavotricuspid isthmus (CTI) ablation, and PVI + adjunctive (superior vena cava isolation, coronary sinus, vein of Marshall, atypical atrial flutter lines, other). Adjusted odds of adverse events were calculated using multivariable logistic regression. A total of 50 937 patients [PAF: 30 551 (60%), persistent AF: 20 386 (40%)] were included. Among those with PAF, there were no differences in the adjusted odds of complications between PVI + CTI or PVI + adjunctive when compared with PVI only. Among persistent AF, PVI + adjunctive was associated with a higher risk of any complication [3.0 vs. 4.5%, odds ratio (OR) 1.30, 95% confidence interval (CI) 1.07-1.58] and major complication (0.8 vs. 1.4%, OR 1.56, 95% CI 1.10-2.21), while no differences were observed in PVI + CTI compared with PVI only. Overall, there was high heterogeneity in adjunctive lesion type, and those receiving adjunctive lesions had a higher comorbidity burden. CONCLUSION: Additional CTI ablation was common without an increased risk of complications. Adjunctive lesions other than CTI are commonly performed in those with more comorbidities and were associated with an increased risk of complications in persistent AF, although the current analysis is limited by high heterogeneity in adjunctive lesion set type.

Watchman device migration and embolization: A report from the NCDR LAAO Registry.

INTRODUCTION: Incomplete anchoring of the Watchman left atrial appendage closure (LAAO) device can result in substantial device migration or device embolization (DME) requiring percutaneous or surgical retrieval. METHODS: We performed a retrospective analysis of Watchman procedures (January 2016 through March 2021) reported to the National Cardiovascular Data Registry LAAO Registry. We excluded patients with prior LAAO interventions, no device released, and missing device information. In-hospital events were assessed among all patients and postdischarge events were assessed among patients with 45-day follow-up. RESULTS: Of 120 278 Watchman procedures, the in-hospital DME rate was 0.07% (n = 84) and surgery was commonly performed (n = 39). In-hospital mortality rate was 14% among patients with DME and 20.5% among patients who underwent surgery. In-hospital DME was more common: at hospitals with a lower median annual procedure volume (24 vs. 41 procedures, p < .0001), with Watchman 2.5 versus Watchman FLX devices (0.08% vs. 0.04%, p = .0048), with larger LAA ostia (median 23 vs. 21 mm, p = .004), and with a smaller difference between device and LAA ostial size (median difference 4 vs. 5 mm, p = .04). Of 98 147 patients with 45-day follow-up, postdischarge DME occurred in 0.06% (n = 54) patients and cardiac surgery was performed in 7.4% (n = 4) of cases. The 45-day mortality rate was 3.7% (n = 2) among patients with postdischarge DME. Postdischarge DME was more common among men (79.7% of events but 58.9% of all procedures, p = .0019), taller patients (177.9 vs. 172 cm, p = .0005), and those with greater body mass (99.9 vs. 85.5 kg, p = .0055). The rhythm at implant was less frequently AF among patients with DME compared to those without (38.9% vs. 46.9%, p = .0098). CONCLUSION: While Watchman DME is rare, it is associated with high mortality and frequently requires surgical retrieval, and a substantial proportion of events occur after discharge. Due to the severity of DME events, risk mitigation strategies and on-site cardiac surgical back-up are of paramount importance.

Variation in hospital use of cardiac resynchronization therapy-defibrillator among eligible patients and association with clinical outcomes.

BACKGROUND: Despite strong guideline recommendations for cardiac resynchronization therapy-defibrillator (CRT-D) in select patients, this therapy is underutilized with substantial variation among hospitals, and the association of this variation with outcomes is unknown. OBJECTIVE: The purpose of this study was to assess whether facility variation in CRT-D utilization is associated with differences in hospital-level outcomes. METHODS: We linked Medicare claims data with the National Cardiovascular Data Registry's ICD Registry from 2010 to 2015. We calculated the intraclass correlation coefficient to quantify the degree of variation in patient-level CRT use that can be explained by interfacility variation on a hospital level. To quantify the degree of hospital variation in patient-level outcomes (all-cause mortality, readmissions, and cardiac readmissions) that can be attributed to variations in CRT-D use, we utilized multilevel modeling. RESULTS: The study included 30,134 patients across 1377 hospitals. The median rate of CRT-D implantation in those meeting guideline indications was 89%, but there was a wide variation across hospitals. After adjustment, most of the variation (74%) in hospital rates of CRT-D utilization was attributable to the hospital in which the patient was treated. Differences in hospital CRT-D utilization was associated with 8.76%, 5.26%, and 4.71% of differences in hospital mortality, readmissions, and cardiac readmission rates, respectively (P < .001 for all outcomes). CONCLUSION: There is a wide variation in the use of CRT-D across hospitals that was not explained by case mix. Hospital-level variation in CRT-D utilization was associated with clinically significant differences in outcomes. A measure of CRT-D utilization in eligible patients may serve as a useful metric for quality improvement efforts.

Sex-based differences in atrial fibrillation ablation adverse events.

OBJECTIVE: Older, relatively small studies identified female sex as a risk factor for adverse events after catheter ablation for atrial fibrillation (AF). We aimed to assess contemporary sex-based differences in baseline and procedural characteristics, adverse events, and quality of life among adults undergoing catheter ablation for AF. METHODS: In this observational cohort study, we evaluated those enrolled in the National Cardiovascular Data Registry AFib Ablation Registry between January 2016 and September 2020. Using logistic regression, we analysed the association between patient sex and in-hospital adverse events. RESULTS: Among 58 960 adults (34.6% women) from 150 centres undergoing AF ablation by 706 physicians, women were older (68 vs 64 years, p<0.001), had more comorbidities, and had lower AF-related quality of life at the time of ablation (mean Atrial Fibrillation Effect on QualiTy-of-life Questionnaire) score: 51.8 vs 62.2, p<0.001). Women had a higher risk of hospitalisation >1 day (adjusted OR (aOR) 1.41 (95% CI 1.33 to 1.49)), major adverse event (aOR 1.60 (95% CI 1.33 to 1.92)) and any adverse event (aOR 1.57 (95% CI 1.41 to 1.75)). Women had a higher risk of bradycardia requiring pacemaker, phrenic nerve damage, pericardial effusion, bleeding and vascular injury, but had no differences in death or acute pulmonary vein isolation. CONCLUSIONS: Among almost 60 000 patients in the largest prospective registry of AF ablation procedures, female sex was independently associated with a higher risk of hospitalisation >1 day, adverse events, and reduced quality of life, although there were no differences in death or acute pulmonary vein isolation.

Device-Sizing and Associated Complications With Left Atrial Appendage Occlusion: Findings From the NCDR LAAO Registry.

BACKGROUND: Left atrial appendage occlusion is an important alternative to anticoagulation in select patients with nonvalvular atrial fibrillation. Trends in real-world device sizing and associated short-term complications have not been characterized. METHODS: Using the National Cardiovascular Data Left Atrial Appendage Occlusion (NCDR LAAO) Registry, patients who underwent left atrial appendage occlusion with a Watchman 2.5 device from January 1, 2016, to June 30, 2020, were identified. Patients were stratified by device size based on left atrial appendage orifice size, and categorized as receiving a device that was undersized, oversized, or per manufacturer recommendation. Relationships between device sizing and short-term outcomes, including pericardial effusion, device embolism, and significant leak, were assessed. RESULTS: Of the 68 456 patients, 6539 (10.5%) of patients received undersized devices, 17 791 (26.0%) according to manufacturer recommendations, and 44 126 (64.4%) received an oversized device. The 27-mm device was most commonly deployed [21 736 (31.8%)], whereas the smallest and largest devices (21 and 33 mm) were least commonly deployed [7695 (11.2%) and 9077 (13.3%), respectively]. Compared with manufacturer recommended sizing, there was no difference in the odds of pericardial effusion for either undersized (1.048 [95% CI' 0.801-1.372]; P=0.733) or oversized (1.101 [95% CI' 0.933-1.298]; P=0.254) devices. Similarly, relative to manufacturer recommended sizing, the odds of a composite adverse outcome of device migration or embolization and significant peridevice leak at 45 days were similar among undersized devices (1.030 [95% CI' 0.735-1.444]; P=0.863) and favorable for oversized devices (0.701 [95% CI' 0.561-0.876]; P=0.002) devices, primarily driven by lower odds of leak. Selection of oversized devices increased significantly over the study period (from 60.3% in 2016 to 66.0% in 2020; P<0.001). CONCLUSIONS: Among patients undergoing left atrial appendage occlusion with the first-generation Watchman device, receipt of oversized devices was common and increased over time. The high prevalence of oversizing was associated with lower odds of significant leak or device embolization without increased odds of other adverse events.

Comparative Safety of Transcatheter LAAO With the First-Generation Watchman and Next-Generation Watchman FLX Devices.

BACKGROUND: Procedural complications limit the clinical benefit of transcatheter left atrial appendage occlusion (LAAO). Next-generation devices incorporate design modifications intended to improve procedural safety, but their clinical impact has not been described. OBJECTIVES: The aim of this study was to compare in-hospital outcomes for the Watchman FLX with the predicate Watchman 2.5 device. METHODS: The National Cardiovascular Data Registry LAAO Registry was used to identify patients who received the Watchman FLX and an identical number of patients receiving the Watchman 2.5 at the same sites directly preceding the first Watchman FLX case at each site. The primary endpoint was in-hospital major adverse events (MAE), defined as a composite of death, cardiac arrest, stroke, transient ischemic attack, intracranial hemorrhage, systemic arterial embolism, major bleeding, major vascular complication, myocardial infarction, pericardial effusion requiring intervention (percutaneous or surgical), and device embolization. A secondary analysis was performed using 2:1 propensity score matching of patients receiving the Watchman 2.5 or Watchman FLX. RESULTS: The study cohort consisted of 27,013 patients receiving each device. The rate of in-hospital MAE was significantly lower for the Watchman FLX compared with the Watchman 2.5 (1.35% vs 2.40%; adjusted OR: 0.57; 95% CI: 0.50-0.65; P < 0.0001), driven largely by fewer pericardial effusions requiring intervention (0.42% vs 1.23%; adjusted OR: 0.34; 95% CI: 0.28-0.42; P < 0.0001). The Watchman FLX was also associated with significant lower rates of the individual endpoints of in-hospital mortality (0.12% vs 0.24%; P < 0.0001), major bleeding (1.08% vs 2.05%; P < 0.0001), cardiac arrest (0.13% vs 0.24%; P = 0.006), and device embolization (0.02% vs 0.06%; P = 0.028), while myocardial infarction, stroke, and major vascular complications did not differ between groups. Propensity score matching analysis demonstrated similar results, with lower rates of MAE with the Watchman FLX (1.34% vs 2.58%; OR: 0.51; 95% CI: 0.46-0.58; P < 0.0001). CONCLUSIONS: Transcatheter LAAO with the Watchman FLX was associated with lower rates of in-hospital MAE compared with the predicate Watchman device, including mortality, pericardial effusion, major bleeding, cardiac arrest, and device embolization. This may favorably influence the balance of risks and benefits of transcatheter LAAO for stroke prevention in patients with atrial fibrillation.

In-hospital outcomes and readmission in older adults treated with percutaneous coronary intervention for stable ischemic heart disease.

Background: Percutaneous coronary intervention (PCI) for stable ischemic heart disease (SIHD) in older adults requires a meticulous assessment of procedural risks and benefits, but contemporary data on outcomes in this population is lacking. Therefore, we examined the risk of near-term readmission, bleeding, and mortality in high-risk cohort of older adults undergoing inpatient PCI for SIHD. METHODS: We analyzed the National Readmissions Database from 2017 to 2018 to identify index hospitalizations in which PCI was performed for SIHD. Patients were stratified into those ≥ 75 years old (older adults) and those < 75 years old. The primary outcome was 90-day readmission. Secondary outcomes included in-hospital mortality, hospital length of stay (LOS), and total hospital charge. RESULTS: A total of 74,516 patients underwent inpatient PCI for SIHD, of whom 24,075 were older adults. Older adult patients had higher odds of in-hospital mortality (OR = 2.00, 95% CI: 1.68-2.38), intracranial hemorrhage (OR = 2.03, 95% CI: 1.24-3.34), and gastrointestinal hemorrhage (OR = 1.72, 95% CI: 1.43-2.07) during index hospitalization, with longer LOS and in-hospital charge. Older adults also experienced a higher hazard of 90-day readmission for any cause (HR = 1.61, 95% CI: 1.57-1.66) and cardiovascular causes (HR = 1.84, 95% CI: 1.77-1.91). CONCLUSION: Older adults undergoing inpatient PCI for SIHD were at increased risk for in-hospital mortality, periprocedural morbidities, higher cost, and readmissions compared with younger adults. Understanding these differences may improve shared decision-making for patients with SIHD being considered for PCI.

Temporal trends and long-term outcomes among recipients of cardiac resynchronization therapy with defibrillator in the United States, 2011-2015: Insights from the National Cardiovascular Data Registry.

Background: Contemporary data on national trends and outcomes in cardiac resynchronization therapy with defibrillator (CRT-D) recipients following the 2012 updated guidelines has not been studied. Objectives: This study assessed the trends in long-term outcomes among CRT-D Medicare-aged recipients implanted in 2011-2015. Methods: Patients aged ≥65 years undergoing de novo CRT-D implantation in the National Cardiovascular Data Implantable Cardiac Defibrillator Registry from 2011-2015 with follow-up through 2017 using Medicare data were included and stratified by year of implant. Patient characteristics, in-hospital outcomes, and outcomes up to 2 years following implant were evaluated. Results: Among 53,174 patients (aged 75.6-6.4 years, 29.7% women) implanted with CRT-D from 2011 to 2015, there was an increase in implantations based on guideline-concordant recommendations (81.0% to 84.7%, P < .001). Compared to 2011, in-hospital procedural complications decreased in 2015 (3.9% vs 2.9%; adjusted odds ratio, 0.76, 95% confidence interval, 0.66-0.88, P < .001), driven in part by decreased lead dislodgement (1.4% vs 1.0%). After multivariable adjustment, there was a lower risk of all-cause hospitalization, cardiovascular hospitalization, and mortality at 2-year follow-up in 2015 as compared to 2011, while there were no differences in heart failure hospitalizations at follow-up. Conclusion: Among Medicare beneficiaries receiving CRT-D from 2011 to 2015, there was an increase in implantations based on guideline-concordant recommendations. Furthermore, there has been a reduction in in-hospital complications and long-term outcomes, including cardiovascular hospitalization, all-cause hospitalization, and mortality; however, there has been no difference in the risk of heart failure hospitalization after adjustment.