Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Safety and Effectiveness in the ADMIRE Pivotal Trial.

BACKGROUND: Evidence from clinical trials of early pulsed field ablation (PFA) systems in treating atrial fibrillation has demonstrated their promising potential to reduce complications associated with conventional thermal modalities while maintaining efficacy. However, the lack of a fully integrated mapping system, a staple technology of most modern electrophysiology procedures, poses limitations in lesion creation and workflow options. A novel variable-loop PFA catheter integrated with an electroanatomic mapping system has been developed that allows for real-time nonfluoroscopic procedural guidance and lesion indexing as well as feedback of tissue-to-catheter proximity. ADMIRE (Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the Bosense-Webster Irreversible Electroporation Ablation System), a multicenter, single-arm, Food and Drug Administration investigational device exemption study, evaluated the long-term safety and effectiveness of this integrated PFA system in a large United States-based drug-refractory symptomatic paroxysmal atrial fibrillation patient population. METHODS: Using the PFA catheter with a compatible electroanatomic mapping system, patients with drug-refractory symptomatic paroxysmal atrial fibrillation underwent pulmonary vein isolation. The primary safety end point was primary adverse event within 7 days of ablation. The primary effectiveness end point was a composite end point that included 12-month freedom from documented atrial tachyarrhythmia (ie, atrial fibrillation, atrial tachycardia, atrial flutter) episodes, failure to achieve pulmonary vein isolation, use of a nonstudy catheter for pulmonary vein isolation, repeat procedure (except for one redo during blanking), taking a new or previously failed class I or III antiarrhythmic drug at higher dose after blanking, or direct current cardioversion after blanking. RESULTS: At 30 centers, 277 patients with paroxysmal atrial fibrillation (61.5±10.3 years of age; 64.3% male) in the pivotal cohort underwent PFA. More than 25% of the procedures were performed without fluoroscopy. Median (Q1, Q3) pulmonary vein isolation procedure, fluoroscopy, and transpired PFA application times were 81.0 (61.0, 112.0), 7.1 (0.00, 14.3), and 31.0 (24.8, 40.9) minutes, respectively. The primary adverse event rate was 2.9% (8 of 272), with the most common complication being pericardial tamponade. The 12-month primary effectiveness end point was 74.6%. The 1-year freedom from atrial fibrillation, atrial tachycardia, or atrial flutter recurrence rate after blanking was 75.4%. Substantial improvements in quality of life were observed as early as 3 months after the procedure, concurrent with a reduction in multiple health care use measures. CONCLUSIONS: ADMIRE confirmed the safety and effectiveness of the variable-loop PFA catheter, with short procedure and PFA application times and low fluoroscopy exposure. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05293639.

Lessons learned from a delayed diagnosis of atrioesophageal fistula: A multidisciplinary approach.

Atrioesophageal fistulas are a rare complication of radiofrequency ablation (RFA) that requires rapid identification and emergent surgical repair to prevent morbidity and mortality. We report a case of a 32-year-old man with atrial fibrillation presenting with chest pain followed by rapidly progressive sepsis and embolic cerebrovascular accident 23 days after RFA. Subtle initially overlooked findings on multiple computed tomography caused a delay in diagnosis. Atrioesophageal fistulas remain diagnostically challenging. A high index of suspicion coupled with serial computed tomography of the chest with intravenous and oral contrast reviewed by a multimodal team is essential to make a timely diagnosis.

The cost of non-response to cardiac resynchronization therapy: characterizing heart failure events following cardiac resynchronization therapy.

AIMS: The aim of this study is to quantify healthcare resource utilization among non-responders to cardiac resynchronization therapy (CRT-NR) by heart failure (HF) events and influence of comorbidities. METHODS AND RESULTS: The ADVANCE CRT registry (2013-2015) prospectively identified responders/CRT-NRs 6 months post-implant using the clinical composite score. Heart failure event rates and associated cost, both overall and separated for inpatient hospitalizations, office visits, emergency room visits, and observational stays, were quantified. Costs of events were imputed from payments for similar real-world encounters in subjects with CRT-D/P devices in the MarketScan™ commercial and Medicare Supplemental insurance claims databases. Effects of patient demographics and comorbidities on event rates and cost were evaluated. Of 879 US patients (age 69 ± 11 years, 29% female, ischaemic disease 52%), 310 (35%) were CRT-NR. Among CRT-NRs vs. responders, more patients developed HF (41% vs. 11%, P < 0.001), HF event rate was higher (67.0 ± 21.7 vs. 11.4 ± 3.7/100 pt-year, P < 0.001), and HF readmission within 30 days was more common [hazard ratio 7.06, 95% confidence interval (2.1-43.7)]. Inpatient hospitalization was the most common and most expensive event type in CRT-NR. Comorbid HF was increased by diabetes, hypertension, and pulmonary disorders. Over 2 years, compared to CRT responders, each CRT-NR resulted in excess cost of $6388 ($3859-$10 483) to Medicare (P = 0.015) or $10 197 ($6161-$17 394) to private insurances (P = 0.014). CONCLUSION: Healthcare expenditures associated with contemporary CRT non-response management are among the highest for any HF patient group. This illustrates an unmet need for interventions to improve HF outcomes and reduce costs among some CRT recipients.

Performance of an automatic external cardioverter-defibrillator algorithm in the discrimination of supraventricular from ventricular tachycardia.

An automatic external cardioverter-defibrillator (AECD) with a programmable supraventricular-ventricular tachycardia (VT) zone underwent evaluation of arrhythmia discrimination performance in the electrophysiologic laboratory during induced supraventricular tachycardia (SVT) and unipolar and bipolar atrial pacing. The AECD SVT zone was programmed so that the induced SVT rate would fall within this zone. Atrial pacing was also performed at a rate within this zone. The ability of the AECD to accurately discriminate between VT and SVT and to recommend shock delivery was assessed. A total of 98 patients underwent conventional diagnostic electrophysiologic studies (49 men, age 59 +/- 19 years) with a total of 55 inducible sustained SVTs. High right atrial pacing was performed in 56 patients in unipolar and in 82 patients in bipolar fashion. In response to induced sustained SVT, the AECD correctly classified 47 episodes as nonshockable, 4 incorrectly as shockable, and 4 episodes correctly as shockable with a resultant sensitivity of 100% and specificity of 92%. Bipolar high right atrial pacing was correctly identified as nonshockable in 75 episodes, incorrectly identified as shockable in 5 episodes, and correctly identified as shockable in 2 episodes with a resultant sensitivity of 100% and specificity of 94%. The Powerheart AECD accurately discriminates SVT from VT and is expected to correctly deliver automatic external shocks rapidly in the presence of spontaneous life-threatening tachycardia and appropriately withhold therapy during SVT.