A randomized sham-controlled study of pulmonary vein isolation in symptomatic atrial fibrillation (The SHAM-PVI study): Study design and rationale.

INTRODUCTION: Pulmonary vein (PV) isolation has been shown to reduce atrial fibrillation (AF) burden and symptoms in patients. However, to date previous studies have been unblinded raising the possibility of a placebo effect to account for differences in outcomes. HYPOTHESIS & METHODS: The objective of this study is to compare PV isolation to a sham procedure in patients with symptomatic AF. The SHAM-PVI study is a double blind randomized controlled clinical trial. 140 patients with symptomatic paroxysmal or persistent AF will be randomized to either PV isolation (with cryoballoon ablation) or a sham procedure (with phrenic nerve pacing). All patients will receive an implantable loop recorder. The primary outcome is total AF burden at 6 months postrandomisation (excluding the 3 month blanking period). Key secondary outcomes include (1) time to symptomatic and asymptomatic atrial tachyarrhythmia (2) total atrial tachyarrhythmia episodes and (3) patient reported outcome measures. RESULTS: Enrollment was initiated in January 2020. Through April 2023 119 patients have been recruited. Results are expected to be disseminated in 2024. CONCLUSION: This study compares PV isolation using cryoablation to a sham procedure. The study will estimate the effect of PV isolation on AF burden.

Ripple-AT Study: A Multicenter and Randomized Study Comparing 3D Mapping Techniques During Atrial Tachycardia Ablations.

BACKGROUND: Ripple mapping (RM) is an alternative approach to activation mapping of atrial tachycardia (AT) that avoids electrogram annotation. We tested whether RM is superior to conventional annotation based local activation time (LAT) mapping for AT diagnosis in a randomized and multicenter study. METHODS: Patients with AT were randomized to either RM or LAT mapping using the CARTO3v4 CONFIDENSE system. Operators determined the diagnosis using the assigned 3D mapping arm alone, before being permitted a single confirmatory entrainment manuever if needed. A planned ablation lesion set was defined. The primary end point was AT termination with delivery of the planned ablation lesion set. The inability to terminate AT with this first lesion set, the use of more than one entrainment manuever, or the need to crossover to the other mapping arm was defined as failure to achieve the primary end point. RESULTS: One hundred five patients from 7 centers were recruited with 22 patients excluded due to premature AT termination, noninducibility or left atrial appendage thrombus. Eighty-three patients (pts; RM=42, LAT=41) completed mapping and ablation within the 2 groups of similar characteristics (RM versus LAT: prior ablation or cardiac surgery n=35 [83%] versus n=35 [85%], P=0.80). The primary end point occurred in 38/42 pts (90%) in the RM group and 29/41pts (71%) in the LAT group (P=0.045). This was achieved without any entrainment in 31/42 pts (74%) with RM and 18/41 pts (44%) with LAT (P=0.01). Of those patients who failed to achieve the primary end point, AT termination was achieved in 9/12 pts (75%) in the LAT group following crossover to RM with entrainment, but 0/4 pts (0%) in the RM group crossing over to LAT mapping with entrainment (P=0.04). CONCLUSIONS: RM is superior to LAT mapping on the CARTO3v4 CONFIDENSE system in guiding ablation to terminate AT with the first lesion set and with reduced entrainment to assist diagnosis. CLINICAL TRIALS REGISTRATION: https://www.clinicaltrials.gov. Unique identifier: NCT02451995.

How do we diagnose syncope?

INTRODUCTION: The Eastbourne Syncope Assessment Study aims to increase diagnostic yield in unexplained syncope while reducing investigational costs. The initial study phase was a retrospective analysis of every presentation to the Eastbourne General Hospital (a busy nontertiary center in the United Kingdom serving a population of 250,000; 24% are older than 65 years) with syncope for the year 1998. METHODS AND RESULTS: A total of 1,334 cases with syncopal codes were identified. Six hundred sixty patients (mean age 64 years) had actually suffered an episode of syncope. Forty percent had recurrent syncope, with a mean of 4.7 previous episodes. Twenty-nine percent of syncope cases remained undiagnosed. Forty-four percent were diagnosed as vasovagal, 12% neurologic, 6% due to an arrhythmia, 2% drug related, and 2% due to hemorrhage. Thirteen different types of investigation were undertaken, with an overall total of 3,264 investigations performed at a cost of Pound Sterling 104,285. Diagnosis was achieved by history and examination alone in 61% of cases. Excluding history and examination, the most cost-effective diagnostic tools were the 7-day patient-activated recorder (R test) and tilt testing (Pound Sterling 260 and Pound Sterling 401 per diagnosis, respectively). Investigations also were graded by their relative diagnostic power. Hospital admission alone accounted for 67% of the cost of investigating syncope. CONCLUSION: In syncope, diagnostic rates can be improved and investigational costs reduced by concentrating on the most specific, sensitive, and cost-effective investigations and by minimizing hospital stay. Such a protocol currently is under investigation at our institution.