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1.
Rheum Dis Clin North Am ; 50(3): 381-408, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38942576

RESUMEN

Systemic diseases can cause heart block owing to the involvement of the myocardium and thereby the conduction system. Younger patients (<60) with heart block should be evaluated for an underlying systemic disease. These disorders are classified into infiltrative, rheumatologic, endocrine, and hereditary neuromuscular degenerative diseases. Cardiac amyloidosis owing to amyloid fibrils and cardiac sarcoidosis owing to noncaseating granulomas can infiltrate the conduction system leading to heart block. Accelerated atherosclerosis, vasculitis, myocarditis, and interstitial inflammation contribute to heart block in rheumatologic disorders. Myotonic, Becker, and Duchenne muscular dystrophies are neuromuscular diseases involving the myocardium skeletal muscles and can cause heart block.


Asunto(s)
Bloqueo Cardíaco , Humanos , Bloqueo Cardíaco/diagnóstico , Bloqueo Cardíaco/etiología , Enfermedades Reumáticas/complicaciones , Enfermedades Neuromusculares/diagnóstico , Enfermedades Neuromusculares/fisiopatología , Sarcoidosis/diagnóstico , Sarcoidosis/complicaciones , Amiloidosis/diagnóstico , Amiloidosis/complicaciones
2.
Heart Rhythm ; 2024 Jun 26.
Artículo en Inglés | MEDLINE | ID: mdl-38942104

RESUMEN

The complexity of cardiac electrophysiology procedures has increased significantly over the past three decades. Anesthesia requirements of these procedures can be different based on patient- and procedure-specific factors. This manuscript outlines various anesthesia strategies for cardiac implantable electronic devices and electrophysiology procedures including pre-procedural, procedural and post-procedural management. A team-based approach with collaboration between cardiac electrophysiologists and anesthesiologists is required with careful pre-procedural and intra-procedural planning. Given the recent advances in electrophysiology, there is a need for specialized cardiac electrophysiology anesthesia care to improve the efficacy and safety of the procedures.

3.
JACC Clin Electrophysiol ; 10(6): 1078-1086, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38703164

RESUMEN

BACKGROUND: In patients with persistent atrial fibrillation (PerAF), antiarrhythmic drugs (AADs) are considered a first-line rhythm-control strategy, whereas catheter ablation is a reasonable alternative. OBJECTIVES: This study sought to examine the prevalence, patient characteristics, and clinical outcomes of patients with PerAF who underwent catheter ablation as a first or second-line strategy. METHODS: This multicenter observational study included consecutive patients with PerAF who underwent first-time ablation between January 2020 and September 2021 in 9 medical centers in the United States. Patients were divided into those who underwent ablation as first-line therapy and those who had ablation as second-line therapy. Patient characteristics and clinical outcomes were compared between the groups. RESULTS: A total of 2,083 patients underwent first-time ablation for PerAF. Of these, 1,086 (52%) underwent ablation as a first-line rhythm-control treatment. Compared with patients treated with AADs as first-line therapy, these patients were predominantly male (72.6% vs 68.1%; P = 0.03), with a lower frequency of hypertension (64.0% vs 73.4%; P < 0.001) and heart failure (19.1% vs 30.5%; P < 0.001). During a mean follow-up of 325.9 ± 81.6 days, arrhythmia-free survival was similar between the groups (HR: 1.13; 95% CI: 0.92-1.41); however, patients in the second-line ablation strategy were more likely to continue receiving AAD therapy (41.5% vs 15.9%; P < 0.001). CONCLUSIONS: A first-line ablation strategy for PerAF is prevalent in the United States, particularly in men with fewer comorbidities. More data are needed to identify patients with PerAF who derive benefit from an early intervention strategy.


Asunto(s)
Antiarrítmicos , Fibrilación Atrial , Ablación por Catéter , Humanos , Fibrilación Atrial/cirugía , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/epidemiología , Fibrilación Atrial/terapia , Masculino , Ablación por Catéter/estadística & datos numéricos , Femenino , Persona de Mediana Edad , Anciano , Antiarrítmicos/uso terapéutico , Resultado del Tratamiento , Estados Unidos/epidemiología
4.
Heart Rhythm ; 2024 May 16.
Artículo en Inglés | MEDLINE | ID: mdl-38762137

RESUMEN

BACKGROUND: Identification of patients at risk for atrial fibrillation (AF) after typical atrial flutter (tAFL) ablation is important to guide monitoring and treatment. OBJECTIVE: The purpose of this study was to create and validate a risk score to predict AF after tAFL ablation METHODS: We identified patients who underwent tAFL ablation with no AF history between 2017 and 2022 and randomly allocated to derivation and validation cohorts. We collected clinical variables and measured conduction parameters in sinus rhythm on an electrophysiology recording system (CardioLab, GE Healthcare). Univariate and multivariate logistic regressions (LogR) were used to evaluate association with AF development. RESULTS: A total of 242 consecutive patients (81% male; mean age 66 ± 11 years) were divided into derivation (n =142) and validation (n = 100) cohorts. Forty-two percent developed AF over median follow-up of 330 days. In multivariate LogR (derivation cohort), proximal to distal coronary sinus time (pCS-dCS) ≥70 ms (odds ratio [OR] 16.7; 95% confidence interval [CI] 5.6-49), pCS time ≥36 ms (OR 4.5; 95% CI 1.5-13), and CHADS2-VASc score ≥3 (OR 4.3; 95% CI 1.6-11.8) were independently associated with new AF during follow-up. The Atri-Risk Conduction Index (ARCI) score was created with 0 as minimal and 4 as high-risk using pCS-dCS ≥70 ms = 2 points; pCS ≥36 ms = 1 point; and CHADS2-VASc score ≥3 = 1 point. In the validation cohort, 0% of patients with ARCI score = 0 developed AF, whereas 89% of patients with ARCI score = 4 developed AF. CONCLUSION: We developed and validated a risk score using atrial conduction parameters and clinical risk factors to predict AF after tAFL ablation. It stratifies low-, moderate-, and high-risk patients and may be helpful in individualizing approaches to AF monitoring and anticoagulation.

6.
J Innov Card Rhythm Manag ; 15(3): 5803-5804, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38584750
7.
Artículo en Inglés | MEDLINE | ID: mdl-38499825

RESUMEN

BACKGROUND: Cardioneuroablation has been emerging as a potential treatment alternative in appropriately selected patients with cardioinhibitory vasovagal syncope (VVS) and functional AV block (AVB). However the majority of available evidence has been derived from retrospective cohort studies performed by experienced operators. METHODS: The Cardioneuroablation for the Management of Patients with Recurrent Vasovagal Syncope and Symptomatic Bradyarrhythmias (CNA-FWRD) Registry is a multicenter prospective registry with cross-over design evaluating acute and long-term outcomes of VVS and AVB patients treated by conservative therapy and CNA. RESULTS: The study is a prospective observational registry with cross-over design for analysis of outcomes between a control group (i.e., behavioral and medical therapy only) and intervention group (Cardioneuroablation). Primary and secondary outcomes will only be assessed after enrollment in the registry. The follow-up period will be 3 years after enrollment. CONCLUSIONS: There remains a lack of prospective multicentered data for long-term outcomes comparing conservative therapy to radiofrequency CNA procedures particularly for key outcomes including recurrence of syncope, AV block, durable impact of disruption of the autonomic nervous system, and long-term complications after CNA. The CNA-FWRD registry has the potential to help fill this information gap.

10.
Catheter Cardiovasc Interv ; 102(7): 1357-1363, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-37735946

RESUMEN

OBJECTIVES: We sought to produce a simple scoring system that can be applied at clinical visits before transcatheter aortic valve replacement (TAVR) to stratify the risk of permanent pacemaker (PPM) after the procedure. BACKGROUND: Atrioventricular block is a known complication of TAVR. Current models for predicting the risk of PPM after TAVR are not designed to be applied clinically to assist with preprocedural planning. METHODS: Patients undergoing TAVR at the University of Colorado were split into a training cohort for the development of a predictive model, and a testing cohort for model validation. Stepwise and binary logistic regressions were performed on the training cohort to produce a predictive model. Beta coefficients from the binary logistic regression were used to create a simple scoring system for predicting the need for PPM implantation. Scores were then applied to the validation cohort to assess predictive accuracy. RESULTS: Patients undergoing TAVR from 2013 to 2019 were analyzed: with 483 included in the training cohort and 123 included in the validation cohort. The need for a pacemaker was associated with five preprocedure variables in the training cohort: PR interval > 200 ms, Right bundle branch block, valve-In-valve procedure, prior Myocardial infarction, and self-Expandable valve. The PRIME score was developed using these clinical features, and was highly accurate for predicting PPM in both the training and model validation cohorts (area under the curve 0.804 and 0.830 in the model training and validation cohorts, respectively). CONCLUSIONS: The PRIME score is a simple and accurate preprocedural tool for predicting the need for PPM implantation after TAVR.


Asunto(s)
Estenosis de la Válvula Aórtica , Marcapaso Artificial , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Estimulación Cardíaca Artificial , Resultado del Tratamiento , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Factores de Riesgo , Estudios Retrospectivos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía
11.
Ann Noninvasive Electrocardiol ; 28(5): e13073, 2023 09.
Artículo en Inglés | MEDLINE | ID: mdl-37515396

RESUMEN

BACKGROUND: The use of a Left Ventricular Assist Device (LVAD) in patients with advanced heart failure refractory to optimal medical management has progressed steadily over the past two decades. Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular tachyarrhythmia (VTA). We hypothesize that a novel prophylactic intra-operative VTA ablation protocol at the time of LVAD implantation may reduce the recurrent VTA and adverse events postimplant. METHODS: We designed a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA in the previous 5 years. Enrolled patients will be randomized in a 1:1 fashion to intra-operative VTA ablation (n = 50) versus conventional medical management (n = 50) with LVAD implant. Arrhythmia outcomes data will be captured by an implantable cardioverter defibrillator (ICD) to monitor VTA events, with a uniform ICD programming protocol. Patients will be followed prospectively over a mean of 18 months (with a minimum of 9 months) after LVAD implantation to evaluate recurrent VTA, adverse events, and procedural outcomes. Secondary endpoints include right heart function/hemodynamics, healthcare utilization, and quality of life. CONCLUSION: The primary aim of this first-ever randomized trial is to assess the efficacy of intra-operative ablation during LVAD surgery in reducing VTA recurrence and improving clinical outcomes for patients with a history of VTA.


Asunto(s)
Desfibriladores Implantables , Insuficiencia Cardíaca , Corazón Auxiliar , Taquicardia Ventricular , Humanos , Corazón Auxiliar/efectos adversos , Estudios Prospectivos , Calidad de Vida , Factores de Riesgo , Electrocardiografía , Arritmias Cardíacas , Taquicardia Ventricular/etiología , Resultado del Tratamiento
12.
Circ Arrhythm Electrophysiol ; 16(8): 468-474, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-37485688

RESUMEN

BACKGROUND: Subcutaneous implantable cardioverter defibrillators (S-ICDs) are an attractive alternative to transvenous ICDs among those not requiring pacing. However, the risks of damage to the S-ICD electrode during sternotomy and adverse interactions with sternal wires remain unclear. We sought to determine the rates of damage to the S-ICD lead during sternotomy, inappropriate shocks from electrical noise due to interaction with sternal wires, and failure to terminate spontaneous or induced ventricular arrhythmias. METHODS: Retrospective, multicenter study of patients undergoing sternotomy before or after S-ICD implantation. Clinical, procedural, and device-related data were collected by each center and analyzed by the coordinating center. These data were compared with a historical control cohort of nonsternotomy patients. RESULTS: Of 196 identified patients (52±16 years, 47 women), 166 underwent S-ICD implantation after sternotomy and 30 sternotomy after S-ICD. There was no damage to any lead among those who underwent sternotomy after S-ICD. Defibrillation threshold testing was performed in 63% at implant, with 91% first shock success. During a median follow-up of 29 months (range, 1-188), S-ICD first shocks successfully terminated spontaneous ventricular arrhythmias in 31 of 32 patients (97%). Inappropriate shocks occurred in 22 patients, most commonly related to T wave oversensing (n=14). Compared with the nonsternotomy controls, there were no differences in rates of first shock success for induced or spontaneous arrhythmias or rate of inappropriate shocks. CONCLUSIONS: Sternotomy before or after S-ICD does not confer additional risk relative to a historical control group without sternotomy.


Asunto(s)
Desfibriladores Implantables , Humanos , Femenino , Desfibriladores Implantables/efectos adversos , Esternotomía/efectos adversos , Estudios Retrospectivos , Resultado del Tratamiento , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/terapia , Arritmias Cardíacas/etiología , Muerte Súbita Cardíaca/etiología , Muerte Súbita Cardíaca/prevención & control
13.
Cardiol Clin ; 41(3): 429-448, 2023 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-37321693

RESUMEN

Systemic diseases can cause heart block owing to the involvement of the myocardium and thereby the conduction system. Younger patients (<60) with heart block should be evaluated for an underlying systemic disease. These disorders are classified into infiltrative, rheumatologic, endocrine, and hereditary neuromuscular degenerative diseases. Cardiac amyloidosis owing to amyloid fibrils and cardiac sarcoidosis owing to noncaseating granulomas can infiltrate the conduction system leading to heart block. Accelerated atherosclerosis, vasculitis, myocarditis, and interstitial inflammation contribute to heart block in rheumatologic disorders. Myotonic, Becker, and Duchenne muscular dystrophies are neuromuscular diseases involving the myocardium skeletal muscles and can cause heart block.


Asunto(s)
Artritis Reumatoide , Cardiopatías , Distrofias Musculares , Miocarditis , Humanos , Distrofias Musculares/complicaciones , Arritmias Cardíacas , Bloqueo Cardíaco/complicaciones , Miocardio , Miocarditis/complicaciones , Artritis Reumatoide/complicaciones , Cardiopatías/etiología
14.
JACC Clin Electrophysiol ; 9(8 Pt 1): 1404-1408, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-37227346

RESUMEN

The authors sought to evaluate a method for improving radiofrequency (RF) lesion durability using doxorubicin encased in heat-sensitive liposomes (HSL-dox). Using a porcine model, RF ablations were performed in the right atrium after systemic infusion of either HSL-dox or saline control given immediately before mapping and ablation. Lesion geometry was measured with voltage mapping immediately postablation and after 2 weeks of survival. After 2 weeks, lesions demonstrated less regression in scar area in HSL-dox-exposed animals compared with control animals. We demonstrate improved RF lesion durability in animals treated with HSL-dox, and the cardiotoxic effect was more pronounced after RF applications with higher power and longer duration.


Asunto(s)
Calor , Liposomas , Porcinos , Animales , Miocardio , Doxorrubicina/uso terapéutico , Atrios Cardíacos
15.
J Am Heart Assoc ; 12(9): e028483, 2023 05 02.
Artículo en Inglés | MEDLINE | ID: mdl-37119087

RESUMEN

Background Rhythm management is a complex decision for patients with atrial fibrillation (AF). Although clinical trials have identified subsets of patients who might benefit from a given rhythm-management strategy, for individual patients it is not always clear which strategy is expected to have the greatest mortality benefit or durability. Methods and Results In this investigation 52 547 patients with a new atrial fibrillation diagnosis between 2010 and 2020 were retrospectively identified. We applied a type of artificial intelligence called tabular Q-learning to identify the optimal initial rhythm-management strategy, based on a composite outcome of mortality, change in treatment, and sustainability of the given treatment, termed the reward function. We first applied an unsupervised learning algorithm using a variational autoencoder with K-means clustering to cluster atrial fibrillation patients into 8 distinct phenotypes. We then fit a Q-learning algorithm to predict the best outcome for each cluster. Although rate-control strategy was most frequently selected by treating providers, the outcome was superior for rhythm-control strategies across all clusters. Subjects in whom provider-selected treatment matched the Q-table recommendation had fewer total deaths (4 [8.5%] versus 473 [22.4%], odds ratio=0.32, P=0.02) and a greater reward (P=4.8×10-6). We then demonstrated application of dynamic learning by updating the Q-table prospectively using batch gradient descent, in which the optimal strategy in some clusters changed from cardioversion to ablation. Conclusions Tabular Q-learning provides a dynamic and interpretable approach to apply artificial intelligence to clinical decision-making for atrial fibrillation. Further work is needed to examine application of Q-learning prospectively in clinical patients.


Asunto(s)
Fibrilación Atrial , Humanos , Fibrilación Atrial/terapia , Fibrilación Atrial/tratamiento farmacológico , Antiarrítmicos/uso terapéutico , Estudios Retrospectivos , Inteligencia Artificial , Cardioversión Eléctrica
16.
J Innov Card Rhythm Manag ; 14(3): 5384, 2023 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-36998416
17.
J Cardiovasc Electrophysiol ; 34(4): 880-887, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36682068

RESUMEN

INTRODUCTION: Esophageal injury is a well-known complication associated with catheter ablation. Though novel methods to mitigate esophageal injury have been developed, few studies have evaluated temperature gradients with catheter ablation across the posterior wall of the left atrium, interstitium, and esophagus. METHODS: To investigate temperature gradients across the tissue, we developed a porcine heart-esophageal model to perform ex vivo catheter ablation on the posterior wall of the left atrium (LA), with juxtaposed interstitial tissue and esophagus. Circulating saline (5 L/min) was used to mimic blood flow along the LA and alteration of ionic content to modulate impedance. Thermistors along the region of interest were used to analyze temperature gradients. Varying time and power, radiofrequency (RF) ablation lesions were applied with an externally irrigated ablation catheter. Ablation strategies were divided into standard approaches (SAs, 10-15 g, 25-35 W, 30 s) or high-power short duration (HPSD, 10-15 g, 40-50 W, 10 s). Temperature gradients, time to the maximum measured temperature, and the relationship between measured temperature as a function of distance from the site of ablation was analyzed. RESULTS: In total, five experiments were conducted each utilizing new porcine posterior LA wall-esophageal specimens for RF ablation (n = 60 lesions each for SA and HPSD). For both SA and HPSD, maximum temperature rise from baseline was markedly higher at the anterior wall (AW) of the esophagus compared to the esophageal lumen (SA: 4.29°C vs. 0.41°C, p < .0001 and HPSD: 3.13°C vs. 0.28°C, p < .0001). Across ablation strategies, the average temperature rise at the AW of the esophagus was significantly higher with SA relative to HPSD ablation (4.29°C vs. 3.13°C, p = .01). From the start of ablation, the average time to reach a maximum temperature as measured at the AW of the esophagus with SA was 36.49 ± 12.12 s, compared to 16.57 ± 4.54 s with HPSD ablation, p < .0001. Fit to a linear scale, a 0.37°C drop in temperature was seen for every 1 cm increase in distance from the site of ablation and thermistor location at the AW of the esophagus. CONCLUSION: Both SA and HPSD ablation strategies resulted in markedly higher temperatures measured at the AW of the esophagus compared to the esophageal lumen, raising concern about the value of clinical intraluminal temperature monitoring. The temperature rise at the AW was lower with HPSD. A significant time delay was seen to reach the maximum measured temperature and a modest increase in distance between the site of ablation and thermistor location impacted the accuracy of monitored temperatures.


Asunto(s)
Fibrilación Atrial , Ablación por Catéter , Animales , Porcinos , Temperatura , Fibrilación Atrial/cirugía , Atrios Cardíacos , Esófago/lesiones , Ablación por Catéter/métodos
18.
J Cardiovasc Electrophysiol ; 34(3): 593-597, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36598431

RESUMEN

INTRODUCTION: Pericardial bleeding is a rare but life-threatening complication of atrial fibrillation (AF) ablation. Patients taking uninterrupted oral anticoagulation (AC) may be at increased risk for refractory bleeding despite pericardiocentesis and administration of protamine. In such cases, andexanet alfa can be given to reverse rivaroxaban or apixaban. In this study, we aim to describe the rate of acute hemostasis and thromboembolic complications with andexanet for refractory pericardial bleeding during AF ablation. METHODS AND RESULTS: In this multicenter, case series, participating centers identified patients who received a dose of apixaban or rivaroxaban within 24 h of AF ablation, developed refractory pericardial bleeding during the procedure despite pericardiocentesis and administration of protamine and received andexanet. Eleven patients met inclusion criteria, with mean age of 73.5 ± 5.3 years and median CHA2 DS2 -VASc score 4 [3-5]. All patients received protamine and pericardiocentesis, and 9 (82%) received blood products. All patients received a bolus of andexanet followed, in all but one, by a 2-h infusion. Acute hemostasis was achieved in eight patients (73%) while three required emergent surgery. One patient (9%) experienced acute ST-elevation myocardial infarction after receiving andexanet. Therapeutic AC was restarted after a mean of 2.2 ± 1.9 days and oral AC was restarted after a mean of 2.9 ± 1.6 days, with no recurrent bleeding. CONCLUSION: In patients on uninterrupted apixaban or rivaroxaban, who develop refractory pericardial bleeding during AF ablation, andexanet can achieve hemostasis thereby avoiding the need for emergent surgery. However, there is a risk of thromboembolism following administration.


Asunto(s)
Fibrilación Atrial , Ablación por Catéter , Tromboembolia , Humanos , Anciano , Fibrilación Atrial/cirugía , Rivaroxabán/efectos adversos , Inhibidores del Factor Xa , Hemorragia/inducido químicamente , Tromboembolia/etiología , Protaminas , Ablación por Catéter/efectos adversos , Anticoagulantes
19.
Heart Rhythm O2 ; 4(3): 193-199, 2023 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-36569386

RESUMEN

Background: There are limited data on trends in nationwide cardiac electrophysiology (EP) procedures in the United States before and during the global COVID-19 pandemic. Objective: We aimed to understand contemporary EP procedural trends and how the COVID-19 pandemic impacted them. Methods: Trends were obtained from publicly reported Centers for Medicare and Medicaid Services data from 2013 to 2020 (latest available). Rates of catheter-based EP procedures (EP studies and ablations) and cardiac implantable electronic device (CIED) procedures were analyzed. All procedural rates were calculated per 100,000 Medicare beneficiaries (year specific). Procedure physician subspecialty was also reported. Results: From 2013 to 2019, annual rate of all cardiac EP procedures increased from 817.91 to 1089.68 per 100,000 beneficiaries. Catheter-based EP procedures increased from 323.73 to 675.01, while CIED rates decreased from 494.18 to 414.67. While all ablation procedures increased over time, relative proportion of ablation procedures being pulmonary vein isolation (PVI) increased (9.9% of ablations in 2013, to 18.2% in 2019). In 2020, rates of both catheter-based EP procedures and CIED procedures decreased; however, PVI share of ablation continued to increase in 2020 comprising 25.2% of ablation procedures. Conclusion: Rates of EP procedures have increased among Medicare beneficiaries, with catheter-based procedures now eclipsing CIEDs. Additionally, a greater proportion of catheter-based EP procedures are PVI, but they still represent a minority of all ablations. In 2020, rates of EP procedures were attenuated, yet the proportion of PVI ablations increased to over one-fourth of ablation procedures. These data have important implications for the EP workforce.

20.
Circ Cardiovasc Interv ; 15(12): e012183, 2022 12.
Artículo en Inglés | MEDLINE | ID: mdl-36472194

RESUMEN

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.


Asunto(s)
Apéndice Atrial , Fibrilación Atrial , Derrame Pericárdico , Accidente Cerebrovascular , Humanos , Apéndice Atrial/diagnóstico por imagen , Derrame Pericárdico/epidemiología , Derrame Pericárdico/etiología , Resultado del Tratamiento , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/terapia , Fibrilación Atrial/complicaciones , Sistema de Registros , Accidente Cerebrovascular/etiología , Cateterismo Cardíaco/efectos adversos
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