In an unselected population of patients with paroxysmal or persistent atrial fibrillation (AF), the pentaspline pulsed field ablation (PFA) catheter achieved pulmonary vein isolation with 99.9% success and good procedure times.
Presenting the results of the Multi-national Survey on Methods, Efficacy and Safety on the Post-approval Clinical Use of Pulsed Field Ablation (MANIFEST-PF), Vivek Reddy, MD, Mount Sinai Hospital, New York City, said: “We do see a safety profile consistent with preferential tissue ablation. There were very few other unique complications.”
However, the investigators observed what they called a significant rate of generic catheter complications, often seen with other AF catheter procedures.
The pentaspline PFA catheter (Farapulse PFA System, Boston Scientific) is an over-the-wire catheter with variable distal basket and flower shapes. Besides performing pulmonary vein isolation (PVI), the catheter can also treat the left atrial posterior wall (LAPW), often needed in cases of persistent AF.
The relatively new PFA technology uses trains of microsecond-long, high-amplitude electrical pulses. Rather than destroying tissue with heating as with radio frequency ablation or with cold as with cryoablation, PFA creates microscopic pores (electroporation) in the sarcolemma membrane of the myocardium to ablate without significant heating
Cardiomyocytes are particularly sensitive to the electroporation effect, whereas other cell types are more resistant, sparing adjacent tissues.
Real-World Performance
First in human trials had shown the pentaspline catheter to be safe and effective, but in total the trials involved fewer than 150 patients. With limited market release begun in March 2021, the investigators aimed to assess its real-world use and performance though the MANIFEST-PF survey of 24 European Union centers involving 90 operators and 1758 patients, gathering center-level data.
Most study sites (81%) were academic or semi-academic centers, averaged 3.8 operators per center (range, 2 to 11), performed a mean of 73 study procedures per center out of about 700 AF ablations annually.
Patients had a mean age of 61.6 years, CHA2DS2-VASc score of 2.1 (range, 0 to 9), 59% had hypertension, 12% had congestive heart failure, mean left atrial diameter was 39 mm, and mean left ventricular ejection fraction (LVEF) was 54.7% (5% with reduced LVEF).
The majority of patients (57.5%) had paroxysmal AF, but 35.2% had persistent AF, and 3.9% had long-standing persistent AF. Two-thirds of patients had failed some class of antiarrhythmic drug, and 88% were receiving a non-vitamin K oral anticoagulant drug. For 94% of patients, it was their first ablation procedure.
In 82% of patients, the procedures were done under deep sedation without intubation; the rest received general anesthesia with intubation. All patients had one transseptal puncture, the mean procedure time was 65 minutes (range, 38 to 215 minutes), mean fluoroscopy time was 12.7 minutes (range, 4.5 to 33 minutes), and 16% of patients were discharged the same day.
The lesion sets were standardized: for pulmonary vein isolation, 2 x basket → rotate → 2 x basket → 2 x flower → rotate → 2 x flower; for LAPW, 2 x flower at each location. There was no esophageal monitoring, deviation, or cooling.
If we look at the effectiveness, the mean acute PVI success rate was quite high, 99.9%. The median was 100%. If you look at the range, the lowest was 98.9%,” Reddy told congress attendees. Adverse events were uncommon.
There were no esophageal complications, pulmonary vein stenosis, or persistent phrenic nerve injury. A total of 1.6% of patients experienced a major complication, among which were pericardial tamponade (0.97%); stroke (0.4%), one of whom died; vascular complications requiring surgery (0.23%); and one instance of coronary artery spasm. Minor complications affected 3.87% of patients (3.19% vascular), the most common being hematoma, at 2.45%.
Considering cardiac tamponade, the timing of the incidence appeared to reveal a learning curve. Of the 17 cases of tamponade across all 24 centers, 11 of the cases (65%) occurred during the first 20 procedures that any center performed.
Three centers performed some brain imaging. Among the 114 patients scanned, MRI showed silent cerebral ischemic events among 20.
Avail the ongoing Early Bird Offer from www.medicozcommunity.com
Visit our Official Instagram https://www.instagram.com/medicozcommunity/
NExT Exam 2024 Preparation is now Easier go and grab the Early Bird Offer.
Leave feedback about this