Procedural Volume and Outcomes with Atrial Fibrillation Ablation: A Report from the NCDR AFib Ablation Registry.

BACKGROUND: The association between hospital and physician procedure volume outcome has not been well evaluated for atrial fibrillation (AF) ablation in contemporary practice. OBJECTIVE: To determine the association between hospital and physician AF ablation volume and procedural success (isolation of all pulmonary veins) and major adverse events (MAE). METHODS: Procedures reported to the NCDR AFib Ablation Registry between July 2019 and June 2022 were included. Hospital and physician procedural volumes were annualized and stratified into quartiles (Q) to compare outcomes. Three level hierarchical (patient, hospital and physician) models were used to assess the procedural volume outcome relationship. RESULTS: A total of 70,296 first-time AF ablations at 186 U.S. hospitals were included. Overall, procedural success and MAE rate were 98.5 % and 1.0% respectively. With hospital volume (Q4) as a reference, the likelihood of procedural success was lower for Q1 (OR 0.44, 95%CI 0.29-0.68), Q2 (OR 0.50, 95%CI 0.33-0.75) and Q3 (OR 0.60, 95%CI 0.40-0.89); the results were similarly signifant for physician volume. With MAE for hospitals, there was an inverse procedural volume relationship for Q1 (OR 1.78, 95%CI 1.26-2.51) but not for Q2 (OR 1.06, 95%CI 0.77-1.46) or Q3 (OR 1.19, 95%CI 0.89-1.58) and similarly for physicians in Q1 and Q2, not in Q3. An adjusted MAE ≤ 1% was predicted by an annual volume of approximately 190 for hospitals and 60 for physicians. CONCLUSION: In this national cohort, hospital and physician AF ablation procedural volumes were directly related to acute procedural success and inversely related to rates of MAE.

Procedure Volume and Outcomes With WATCHMAN Left Atrial Appendage Occlusion.

BACKGROUND: Procedure volumes are associated with outcomes for many cardiovascular procedures, leading to guidelines on minimum volume thresholds for certain procedures; however, the volume-outcome relationship with left atrial appendage occlusion is poorly understood. As such, we sought to determine the relationship between hospital and physician volume and WATCHMAN left atrial appendage occlusion procedural success overall and with the new generation WATCHMAN FLX device. METHODS: We performed an analysis of WATCHMAN procedures (January 2019 to October 2021) from the National Cardiovascular Data Registry LAAO Registry. Three-level hierarchical generalized linear models were used to assess the adjusted relationship between procedure volume and procedural success (device released with peridevice leak <5 mm, no in-hospital major adverse events). RESULTS: Among 87 480 patients (76.2±8.0 years; 58.8% men; mean CHA2DS2-VASc score, 4.8±1.5) from 693 hospitals, the procedural success rate was 94.2%. With hospital volume Q4 (greatest volume) as the reference, the likelihood of procedural success was significantly less among Q1 (odds ratio [OR], 0.66 [CI, 0.57-0.77]) and Q2 (OR, 0.78 [CI, 0.69-0.90]) but not Q3 (OR, 0.95 [CI, 0.84-1.07]). With physician volume Q4 (greatest volume) as the reference, the likelihood of procedural success was significantly less among Q1 (OR, 0.72 [CI, 0.63-0.82]), Q2 (OR, 0.79 [CI, 0.71-0.89]), and Q3 (OR, 0.88 [CI, 0.79-0.97]). Among WATCHMAN FLX procedures, there was attenuation of the volume-outcome relationships, with statistically significant but modest absolute differences of only ≈1% across volume quartiles. CONCLUSIONS: In this contemporary national analysis, greater hospital and physician WATCHMAN volumes were associated with increased procedure success. The WATCHMAN FLX transition was associated with increased procedural success and less heterogeneity in outcomes across volume quartiles. These findings indicate the importance of understanding the volume-outcome relationship for individual left atrial appendage occlusion devices.

Feasibility of Amulet occluder implantation after failed left atrial appendage occlusion attempt: Insights from the EMERGE LAA postapproval study.

BACKGROUND: Although expertise in left atrial appendage occlusion (LAAO) has grown, certain intricate anatomies may pose challenges, rendering them unsuitable for LAAO with the selected device. OBJECTIVE: This analysis aimed to characterize outcomes of patients with prior failed percutaneous LAAO procedures who underwent a subsequent attempt with an Amulet occluder in the EMERGE LAA postapproval study. METHODS: Patients enrolled in the National Cardiovascular Data Registry LAAO Registry who had an Amulet occluder implantation attempt between Food and Drug Administration approval (August 14, 2021) and June 30, 2023, were evaluated. A safety end point through 7 days or hospital discharge (whichever was later) and major adverse events through 45 days were reported. RESULTS: A total of 8591 patients underwent attempted Amulet occluder implantation, of whom 244 patients had prior failed LAAO. Implantation success was 88.9% and 96.2% in patients with prior failed LAAO and index LAAO, respectively (P < .001). The safety composite end point was low, occurring in 1.6% and 0.8% of patients with prior failed LAAO and index LAAO, respectively (P = .148). Any major adverse event through 45 days occurred in 7.4% and 6.3% of prior failed LAAO and index LAAO patient cohorts, respectively (P = .497); most adverse events were similar between the groups (P > .05). At 45 days, peridevice leak ≤3 mm was achieved in >90% of patients in either group. CONCLUSION: A high degree of implantation success with a low rate of adverse events can be achieved with the Amulet occluder. The findings imply that the dual occlusive mechanism Amulet occluder facilitates successful closure, even in challenging anatomic scenarios.

Ischemic Stroke and Reduced Left Ventricular Ejection Fraction: A Multidisciplinary Approach to Optimize Brain and Cardiac Health.

Reduced left ventricular ejection fraction ≤40%, a known risk factor for adverse cardiac outcomes and recurrent acute ischemic stroke, may be detected during an acute ischemic stroke hospitalization. A multidisciplinary care paradigm informed by neurology and cardiology expertise may facilitate the timely implementation of an array of proven heart failure-specific therapies and procedures in a nuanced manner to optimize brain and cardiac health.

First Experience With Amulet in the United States: Early Insights From EMERGE LAA Postapproval Study.

BACKGROUND: The Food and Drug Administration approved the Amulet occluder (Abbott) after demonstrating safety and effectiveness in the Amulet IDE (AMPLATZER Amulet LAA Occluder) trial. OBJECTIVES: The aim of the EMERGE Left Atrial Appendage study is to evaluate early postapproval outcomes of the Amulet occluder in the United States using data from the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry. METHODS: Patients with a commercial Amulet occluder implant attempt between Food and Drug Administration approval (August 14, 2021) and December 31, 2022, were included. The safety composite endpoint included all-cause death, ischemic stroke, systemic embolism, or device/procedure-related events requiring open cardiac surgery or endovascular intervention between device implantation and 7 days or hospital discharge (whichever is later). Major adverse events through 45 days were also reported and stratified by operator experience (early [<10 cases], moderate [10-29 cases], and high [30+ cases]). RESULTS: A total of 5,499 patients underwent attempted Amulet occluder implantation. Implant success was 95.8%, and complete closure was 97.2% post-left atrial appendage occlusion and 87.1% at 45 days. A safety composite endpoint event occurred in 0.76% patients. Any major adverse event occurred in 2.9% and 5.7% of patients in-hospital and through 45 days, respectively, driven by major bleeding and pericardial effusion (PE) requiring intervention. PE requiring surgery or percutaneous intervention decreased significantly with increasing experience both in-hospital (early vs high operator experience 1.8% vs 1.1%; P = 0.006) and at 45 days (2.3% vs 1.5%; P = 0.012). CONCLUSIONS: The EMERGE Left Atrial Appendage study demonstrates favorable safety and effectiveness of the Amulet occluder in the real-world setting. More experienced operators had improved implant success and fewer PEs, suggesting a learning curve effect implanting this dual occlusive mechanism device.

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.

In-hospital safety outcomes of left atrial appendage occlusion in octogenarians and nonagenarians.

AIMS: Data on safety outcomes of left atrial appendage occlusion (LAAO) in elderly patients are limited. This study aimed to compare the outcomes of LAAO between octogenarians (age 80-89) and nonagenarians (age ≥90) vs. younger patients (age ≤79). METHODS AND RESULTS: We conducted a retrospective cohort study using the National Inpatient Sample database to identify patients hospitalized for LAAO from 2016 to 2020 and to compare in-hospital safety outcomes in octogenarians and nonagenarians vs. younger patients. The primary outcome was a composite of in-hospital all-cause mortality or stroke. Secondary outcomes included procedural complications, length of stay (LOS), and total costs. Outcomes were determined using logistic regression models. Among 84 140 patients hospitalized for LAAO, 32.9% were octogenarians, 2.8% were nonagenarians, and 64.3% were ≤79 years of age. Over the study period, the volume of LAAO increased in all age groups (all Ptrend < 0.01). After adjustment for clinical and demographic factors, octogenarians and nonagenarians had similar odds of in-hospital all-cause mortality or stroke [adjusted odds ratio (aOR) 1.41, 95% confidence interval (CI) 0.93-2.13 for octogenarians; aOR 1.69, 95% CI 0.67-3.92 for nonagenarians], cardiac tamponade, acute kidney injury, major bleeding, and blood transfusion, in addition to similar LOS and total costs compared with younger patients (all P > 0.05). However, octogenarians and nonagenarians had higher odds of vascular complications compared with younger patients (aOR 1.47, 95% CI 1.08-1.99 for octogenarians; aOR 1.60, 95% CI 1.18-2.97 for nonagenarians). CONCLUSION: Octogenarians and nonagenarians undergoing LAAO have a similar safety profile compared with clinically similar younger patients except for higher odds of vascular complications.

Safety and Efficacy of Combining Left Atrial Appendage Occlusion With Another Cardiac Procedure.

BACKGROUND: Clinical outcomes of left atrial appendage occlusion (LAAO) combined with other cardiac procedures have not been previously examined. OBJECTIVES: This study sought to evaluate the safety and efficacy of combining LAAO with other cardiac procedures vs isolated LAAO. METHODS: We conducted a retrospective cohort study using the 2016 to 2020 National Inpatient Sample database to compare patients undergoing LAAO combined with another cardiac procedure vs isolated LAAO. Outcomes included risk-adjusted major adverse cardiovascular events (MACEs), in-hospital mortality, major complications, length of stay (LOS), and total costs. RESULTS: The total cohort included 88,910 weighted encounters, of which 1,225 (1.4%) involved concomitant cardiac procedures. After risk adjustment, patients in the concomitant procedure group had similar odds of MACEs (adjusted OR: 1.82; 95% CI: 0.94-2.74); in-hospital mortality; and complications including stroke, acute kidney injury, major bleeding, blood transfusion, and vascular injury. They also had similar LOS (1 day vs 1 day; P = 0.32) and higher costs ($44,723 vs $32,364; P < 0.01) compared with isolated LAAO but shorter LOS (1 day vs 2 days; P < 0.01) and lower costs ($51,552 vs $63,170; P = 0.04) compared with LAAO with sequential procedures. In subgroup analyses, concomitant atrial fibrillation/atrial flutter ablation had higher adjusted odds of heart block (P < 0.01), and concomitant transcatheter aortic valve replacement had higher adjusted odds of stroke (P = 0.02) and vascular injury (P < 0.01). CONCLUSIONS: In this retrospective observational study, combining LAAO with another cardiac intervention appeared to be associated with similar MACEs and LOS. However, certain complications appeared to be more frequent, and the cost was higher with combined procedures.

Frailty and associated outcomes in patients undergoing percutaneous left atrial appendage occlusion: findings from the NCDR LAAO registry.

BACKGROUND: Frailty is associated with significant morbidity and mortality and may have clinical implications in an advanced age population with atrial fibrillation undergoing left atrial appendage occlusion (LAAO). We sought to develop a novel frailty scale to predict worse outcomes in patients undergoing LAAO. METHODS: Patients in the NCDR LAAO Registry between 2016 and 2021 receiving percutaneous LAAO devices were categorized as non-frail (0 points), pre-frail (1-3 points), or frail (4-5 points) based on a 5-point scale representing multiple domains of frailty: hemoglobin <13.0 g/dL in male, <12.0 g/dL in female; creatinine ≥1.2 mg/dL; albumin <3.5 g/dL; body mass index <20 kg/m2; and increased risk of falls. RESULTS: Of 57,728 patients, 44,360 (76.8%) were pre-frail and 7693 (13.3%) were frail. Compared to non-frail, pre-frail and frail patients were older, had a higher burden of co-morbidities, and more disability based on the Modified Rankin Scale. Compared to non-frail patients after adjustment, frail patients were at higher risk of in-hospital major complication (OR 1.29, 95% 1.02-1.62, p = 0.01), any complication (OR 1.29, 95% CI 1.09-1.52, p = 0.0005), and death (OR 5.79, 95% CI 1.75-19.17, p = 0.001), while no difference was observed in pre-frail patients. At 45-day follow-up, there was no difference in the risk of complications in frail patients as compared to non-frail, although mortality was significantly higher (OR 3.01, 95% CI 1.97-4.85, p < 0.0001). CONCLUSION: A simple and practical frailty scale accurately predicts adverse events in patients undergoing LAAO. The 13% of patients considered frail were at significantly higher risk of in-hospital adverse events and 45-day mortality.

DAPT Is Comparable to OAC Following LAAC With WATCHMAN FLX: A National Registry Analysis.

BACKGROUND: Left atrial appendage occlusion (LAAO) is an approved alternative for stroke prevention in atrial fibrillation for patients with an "appropriate rationale" to avoid long-term oral anticoagulation (OAC). Many patients undergoing LAAO are at high risk of bleeding. OBJECTIVES: This study sought to investigate whether dual antiplatelet therapy (DAPT) is a safe alternative to OAC (direct oral anticoagulation [DOAC] or warfarin) with aspirin after LAAO. METHODS: Using National Cardiovascular Data Registry LAAO registry data, patients undergoing Watchman FLX (Boston Scientific) implantation (August 5, 2020-September 30, 2021) were included in 1:1 propensity-matched analyses comparing discharge medication regimens (DAPT, DOAC/aspirin, or warfarin/aspirin). A composite endpoint (death, stroke, major bleeding, and systemic embolism), its components, and device-related thrombus between discharge and 45 days were evaluated. RESULTS: In 49,968 patients implanted with the Watchman FLX during the study period, the mean age was 77 years, and 40% were women. Postimplant DOAC/aspirin was prescribed in 24,497 patients, warfarin/aspirin in 3,913, and DAPT in 4,155. DAPT patients had more comorbid conditions than patients receiving OAC/aspirin. After propensity score matching, the 45-day composite endpoint rates were similar among the groups (DAPT = 3.44% vs DOAC/aspirin: 4.06%; P = 0.13 and DAPT = 3.23% vs warfarin/aspirin: 3.08%; P = 0.75). Death, stroke, and device-related thrombus were also similar; major bleeding was slightly increased in DOAC/aspirin patients (DAPT = 2.48% vs DOAC/aspirin = 3.25%; P = 0.04 and DAPT = 2.25% vs warfarin/aspirin = 2.22%; P = 0.93). CONCLUSIONS: In a large registry, DAPT had a similar safety profile compared with current Food and Drug Administration-approved postimplant drug regimens of OAC with aspirin following LAAO with the Watchman FLX. Shared decision making for nonpharmacologic stroke prevention should include a discussion of postprocedure medical therapy options.

Intracardiac vs Transesophageal Echocardiography for Left Atrial Appendage Occlusion With Watchman FLX in the U.S.

BACKGROUND: Intraprocedural imaging is critical for device delivery in transcatheter left atrial appendage occlusion (LAAO). Although pivotal trials of LAAO devices were conducted using transesophageal echocardiography (TEE), intracardiac echocardiography (ICE) is an emerging imaging modality. OBJECTIVES: This study compared outcomes after ICE- and TEE-guided Watchman FLX implantation in the SURPASS (SURveillance Post Approval AnalySiS Plan) nationwide LAAO registry. METHODS: Baseline characteristics were compared using chi-square and t-tests. Outcomes were reported in unadjusted and adjusted comparisons via propensity weighting. RESULTS: Between August 2020 and September 2021, LAAO was attempted in 39,759 patients at 698 sites, including 2,272 cases (5.7%) with ICE and 31,835 (80.0%) with TEE. ICE and TEE patients had similar baseline characteristics and mean procedural times (ICE 82 minutes vs TEE 78 minutes). ICE patients were less likely to receive general anesthesia (54% vs 98%, P < 0.01). Successful device implantation (98.3% vs 97.6%) and complete seal rates at 45 days were similar (n = 25,280; 83% vs 82%). Most adverse event rates were similar; unadjusted mortality rates at 45 days were 1.1% for ICE vs 0.8% for TEE (P = 0.14), and 1.0% vs 0.7% (P = 0.27) in adjusted analyses. Even after adjustment, pericardial effusion rates requiring intervention were significantly higher with ICE at 45 days (1.0% vs 0.5%; P = 0.02). This rate decreased as operators performed more ICE-guided procedures, although 82% of operators had performed <10 ICE-guided procedures overall. CONCLUSIONS: In the largest comparison to date, ICE use was infrequent. ICE and TEE both achieved high rates of complete LAAO. ICE was associated with significantly higher rates of pericardial effusion requiring intervention.

Electronic Health Record Embedded Strategies for Improving Care of Patients With Heart Failure.

PURPOSE: A majority of clinical decisions use the electronic health record (EHR) and there is an unmet need to use its capability to help providers to make evidence-based decisions that improve care for heart failure patients. These electronic nudges are rooted in the human psychology of decision-making and often target specific cognitive biases. This review outlines the development of novel EHR nudges and specific lessons learned from each experience to inform the development of future interventions. RECENT FINDINGS: There have been several randomized clinical trials examining the impact of EHR alerts on quality of care for heart failure patients. These interventions have targeted both clinicians and patients. There are features of each trial that inform best practices and future directions for EHR nudges. Recent clinical trials have demonstrated that some EHR alerts can improve care for heart failure patients. These trials utilized default options, involved clinicians in the alert design process, provided actionable recommendations, and aimed to minimize disruptions to typical workflow. Alerts aimed at improving care should be examined in a randomized fashion in order to evaluate their impact on clinician satisfaction and patient care.

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.

Impact of Preprocedure Imaging for Left Atrial Appendage Occlusion: Insights From the NCDR LAAO Registry.

BACKGROUND: The impact of preprocedure imaging on the safety and effectiveness of left atrial appendage occlusion (LAAO) remains unclear. OBJECTIVES: This study sought to determine the rates of use of preprocedure computed tomography (CT)/cardiac magnetic resonance (CMR) and its association with safety and effectiveness of LAAO procedures. METHODS: The National Cardiovascular Data Registry LAAO Registry was used to evaluate patients who underwent attempted LAAO with the WATCHMAN and WATCHMAN FLX devices between January 1, 2016, and June 30, 2021. Safety and effectiveness of LAAO procedures was compared by use vs nonuse of preprocedural CT/CMR. Outcomes of interest included implantation success (deployment and release of device), device success (device released with peridevice leak <5 mm), and procedure success (device released with peridevice leak <5 mm and no in-hospital major adverse events [MAE]). Multivariable logistic regression was used to assess the relationship between preprocedure imaging and outcomes. RESULTS: Preprocedure CT/CMR was used for 18.2% (n = 20,851) of the 114,384 procedures in this study. CT/CMR use was more common among government and university hospitals and hospitals in the Midwest and South; it was less common among patients with uncontrolled hypertension, with abnormal renal function, and without prior thromboembolism. Overall rates of implantation success, device success, and procedure success were 93.4%, 91.2%, and 89.4%, respectively. Preprocedure CT/CMR was independently associated with an increased likelihood of implantation success (OR: 1.08; 95% CI: 1.00-1.17), device success (OR: 1.10; 95% CI: 1.04-1.16), and procedural success (OR: 1.07; 95% CI: 1.02-1.13). MAE were uncommon (2.3%) and not associated with use of preprocedure CT/CMR (OR: 1.02; 95% CI: 0.92-1.12). CONCLUSIONS: Preprocedure CT/CMR was associated with an increased likelihood of successful LAAO implantation; however, the magnitude of benefit appears small and it was not associated with MAE.

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.

SCAI/HRS Expert Consensus Statement on Transcatheter Left Atrial Appendage Closure.

Exclusion of the left atrial appendage to reduce thromboembolic risk related to atrial fibrillation was first performed surgically in 1949. Over the past 2 decades, the field of transcatheter endovascular left atrial appendage closure (LAAC) has rapidly expanded, with a myriad of devices approved or in clinical development. The number of LAAC procedures performed in the United States and worldwide has increased exponentially since the Food and Drug Administration approval of the WATCHMAN (Boston Scientific) device in 2015. The Society for Cardiovascular Angiography & Interventions (SCAI) has previously published statements in 2015 and 2016 providing societal overview of the technology and institutional and operator requirements for LAAC. Since then, results from several important clinical trials and registries have been published, technical expertise and clinical practice have matured over time, and the device and imaging technologies have evolved. Therefore, SCAI prioritized the development of an updated consensus statement to provide recommendations on contemporary, evidence-based best practices for transcatheter LAAC focusing on endovascular devices.

SCAI/HRS expert consensus statement on transcatheter left atrial appendage closure.

Exclusion of the left atrial appendage to reduce thromboembolic risk related to atrial fibrillation was first performed surgically in 1949. Over the past 2 decades, the field of transcatheter endovascular left atrial appendage closure (LAAC) has rapidly expanded, with a myriad of devices approved or in clinical development. The number of LAAC procedures performed in the United States and worldwide has increased exponentially since the Food and Drug Administration approval of the WATCHMAN (Boston Scientific) device in 2015. The Society for Cardiovascular Angiography & Interventions (SCAI) has previously published statements in 2015 and 2016 providing societal overview of the technology and institutional and operator requirements for LAAC. Since then, results from several important clinical trials and registries have been published, technical expertise and clinical practice have matured over time, and the device and imaging technologies have evolved. Therefore, SCAI prioritized the development of an updated consensus statement to provide recommendations on contemporary, evidence-based best practices for transcatheter LAAC focusing on endovascular devices.