Assessment of Catheter Ablation or Antiarrhythmic Drugs for First-line Therapy of Atrial Fibrillation

Turagam, Mohit K.; Musikantow, Daniel; Whang, William; Koruth, Jacob S.; Miller, Marc A.; Langan, Marie-Noelle S.; Sofi, Aamir; Choudry, Subbarao; Dukkipati, Srinivas R.; Reddy, Vivek Y.

doi:10.1001/jamacardio.2021.0852

Cited by 112 publications

(90 citation statements)

References 38 publications

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“…Indeed, clinical data support its use as first-line therapy to not only improve quality of life, but also mortality in heart failure patients, and, in concert with antiarrhythmic drugs, significantly decrease the rates of stroke and mortality in a broad spectrum of AF patients. [2][3][4][5][6][7] Despite improvements in procedural outcomes, there remain safety considerations including stroke, PV stenosis, phrenic nerve palsy, pericardial tamponade and atrio-oesophageal fistula-the latter being the most dreaded complication because of an 50% rate of associated mortality. 8 These complications highlight the weak link shared among all thermal energy-based ablation platforms: as the ablative heat (or cold) wave propagates through tissue, its destructive effect is tissue indiscriminate.…”

Section: Introductionmentioning

confidence: 99%

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Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF)

et al. 2022

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Aims Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical trials. In the MANIFEST-PF survey, we investigated the ‘real world’ performance of the only approved PFA catheter, including acute effectiveness and safety—in particular, rare oesophageal effects and other unforeseen PFA-related complications. Methods and results This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7–291), full cohort included 1758 patients: mean age 61.6 years (range 19–92), female 34%, first-time ablation 94%, paroxysmal/persistent AF 58/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9–100%). Procedure time was 65 min (38–215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each). Conclusion In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of ‘generic’ catheter complications (tamponade, stroke) underscores the need for improvement.

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Section: Introductionmentioning

confidence: 99%

“…No. of operators, mean (min-max)3.8(2)(3)(4)(5)(6)(7)(8)(9)(10)(11) Years in practice, mean (min-max)13.2 (5.3-22.5) Annual no. of AF ablations, mean (min-max) 704 (300-2200) No.…”

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confidence: 99%

Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF)

et al. 2022

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“…Catheter ablation of AF has emerged as the most effective treatment for the restoration of sinus rhythm. 60 Observational studies and registries demonstrate that compared with males, females are referred for ablation less often and later in the disease course. 59 Furthermore, females are less likely to undergo the procedure than males.…”

Section: Atrial Fibrillationmentioning

confidence: 99%

Arrhythmias in Female Patients: Incidence, Presentation and Management

Zeitler

Poole

Chen

et al. 2022

Circulation Research

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There is a growing appreciation for differences in epidemiology, treatment, and outcomes of cardiovascular conditions by sex. Historically, cardiovascular clinical trials have under-represented females, but findings have nonetheless been applied to clinical care in a sex-agnostic manner. Thus, much of the collective knowledge about sex-specific cardiovascular outcomes result from post hoc and secondary analyses. In some cases, these investigations have revealed important sex-based differences with implications for optimizing care for female patients with arrhythmias. This review explores the available evidence related to cardiac arrhythmia care among females, with emphasis on areas in which important sex differences are known or suggested. Considerations related to improving female enrollment in clinical trials as a way to establish more robust clinical evidence for the treatment of females are discussed. Areas of remaining evidence gaps are provided, and recommendations for areas of future research and specific action items are suggested. The overarching goal is to improve appreciation for sex-based differences in cardiac arrhythmia care as 1 component of a comprehensive plan to optimize arrhythmia care for all patients.

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“…Worldwide, atrial fibrillation (AF) is a common atrial tachyarrhythmia among the general population [1]. Although radiofrequency catheter ablation (RFCA) could significantly decrease the mortality risk and dramatically enhance the long-term quality of life for patients with AF [2][3][4][5], the cumulative recurrence rate has been found to be higher for patients suffering from persistent AF (PeAF) after the first RFCA with a longer follow-up [6,7]. In the era of precision medicine, it is crucial to derivate a risk model to predict the long-term recurrence of AF after the first RFCA for patients with PeAF, which could aid in developing individualized treatment strategies.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of a Novel Prognostic Model Predicting the Atrial Fibrillation Recurrence Risk for Persistent Atrial Fibrillation Patients Treated with Nifekalant During the First Radiofrequency Catheter Ablation

Zhai

Zhu

Xiao

et al. 2022

Cardiovasc Drugs Ther

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Background This study aimed to establish and assess a prediction model for patients with persistent atrial fibrillation (AF) treated with nifekalant during the first radiofrequency catheter ablation (RFCA). Methods In this study, 244 patients with persistent AF from January 17, 2017 to December 14, 2017, formed the derivation cohort, and 205 patients with persistent AF from December 15, 2017 to October 28, 2018, constituted the validation cohort. The least absolute shrinkage and selection operator regression was used for variable screening and the multivariable Cox survival model for nomogram development. The accuracy and discriminative capability of this predictive model were assessed according to discrimination (area under the curve [AUC]) and calibration. Clinical practical value was evaluated using decision curve analysis. Results Body mass index, AF duration, sex, left atrial diameter, and the different responses after nifekalant administration were identified as AF recurrence-associated factors, all of which were selected for the nomogram. In the development and validation cohorts, the AUC for predicting 1-year AF-free survival was 0.863 (95% confidence interval (CI) 0.801–0.926) and 0.855 (95% CI 0.782–0.929), respectively. The calibration curves showed satisfactory agreement between the actual AF-free survival and the nomogram prediction in the derivation and validation cohorts. In both groups, the prognostic score enabled stratifying the patients into different AF recurrence risk groups. Conclusions This predictive nomogram can serve as a quantitative tool for estimating the 1-year AF recurrence risk for patients with persistent AF treated with nifekalant during the first RFCA.

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Assessment of Catheter Ablation or Antiarrhythmic Drugs for First-line Therapy of Atrial Fibrillation

Cited by 112 publications

References 38 publications

Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF)

Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF)

Arrhythmias in Female Patients: Incidence, Presentation and Management

Development and Validation of a Novel Prognostic Model Predicting the Atrial Fibrillation Recurrence Risk for Persistent Atrial Fibrillation Patients Treated with Nifekalant During the First Radiofrequency Catheter Ablation

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