The addition of image-guided atrial fibrosis ablation did no longer greatly slice the possibility of recurrence relative to pulmonary vein isolation (PVI) on my own in patients with medication-resistant atrial fibrillation (AFib), in accordance with results of an scheme-to-form out prognosis of the randomized DECAAF II trial.
Nonetheless, there modified into a foremost advantage for the addition of image-guided ablation in the subgroup of patients with stage I or II fibrosis, and this would perhaps be a clinically meaningful finding, Nassir F. Marrouche, MD, reported at the annual congress of the European Society of Cardiology.
“Patients at early phases [of fibrosis] appear to put neatly whereas you happen to put a heavenly job covering the myopathy [with scar formation], and that’s a truly valuable message,” said Dr. Marrouche, the foremost investigator.
The underlying hypothesis of the DECAAF trial modified into that ablation guided with MRI imaging would point to superior to PVI on my own in the medication of resistant AF. There were 843 members randomized at 44 centers. At baseline, all underwent a unhurried gadolinium-enhancement MRI, a arrangement that enables detection of fibrotic tissue.
After randomization, those in the management team underwent identical old of care PVI on my own. These in the intervention team underwent ablation of areas of the atrium revealed to be fibrotic on the MRI scan as well to PVI.
5 Percent Possibility Reduction No longer Predominant
After a median comply with-up of 12 months, recurrence of AFib, which modified into the foremost endpoint, modified into noticed in 43% in the intervention team and 46.1% in the management team. The relative 5% good deal for medication modified into no longer statistically foremost (hazard ratio, 0.95; 95% self belief interval, 0.778-1.17; P = .63).
As phase of the ogle protocol, MRI modified into repeated 3 months after medication in all patients. This authorized the investigators to overview the extent of scar formation when it comes to the fibrosis covered in the intervention team. Honest reviewers rated this protection on ranges from 1 to 5, with 5 representing total protection.
In this prognosis, it modified into found out that ablation resulted in higher ranges of lesion formation in those with early phases of illness, defined as stage I or II fibrosis, but decrease ranges in developed phases.
“The extra myopathy, the extra illness, the much less likelihood of lesion formation,” reported Dr. Marrouche, professor of medication in the allotment of cardiology at Tulane University, Current Orleans.
Attributed to the upper ranges of fibrosis protection, the possibility of AF recurrence over the direction of comply with-up modified into greatly diminished in the intervention relative to the management team on as-handled prognosis in patients who had stage I or II fibrosis at baseline (HR 0.841, 95% CI, 0.732-0.968; P < .05).
Subgroup Info Called Clinically Predominant
“This has grand implications going forward,” Dr. Marrouche maintained. In the context of a series of old trials, including DECAAF I, which connected developed fibrosis with higher possibility of failing ablation, DECAAF II affords the groundwork for “the save and be taught the arrangement to ablate.”
Taken together, the DECAAF data imply that there is rarely any longer a tag in ablating developed fibrosis. Resulting from the center-broken scar formation desired to slice possibility of AF recurrence, there don’t appear to be any advantages to outweigh the reasonably higher possibility of strokes and various negative occasions noticed amongst the intervention team in the DECAAF II trial, in accordance with Dr. Marrouche.
“If the fibrosis is developed, put PVI handiest,” he said.
“DECAAF tells you to try early illness,” he said. Requested if he would now notice these data to medication of patients with early fibrosis, he answered, “Certain, that’s what I’m concluding.”
Just a few recommendations of the fabricate of DECAAF II, equivalent to the usage of a comply with-up MRI to assess ablation at 3 months, were praised by Paul J. Wang, MD, director, Stanford Cardiac Arrhythmia Provider, Stanford (Calif.) University, but he did no longer believe Dr. Marrouche’s interpretation. This incorporated the competition that scar formation modified into less complicated to put in patients with much less atrial fibrosis.
DECAAF II Is No longer a Obvious Trial
In conserving alongside side his reading of the correlation coefficients, expressed as an r tag, which were 0.237 and zero.493 for the low- and excessive-fibrosis groups, respectively, “the variation in lesion formation in low- and excessive-fibrosis groups appears complicated to point to,” Dr. Wang identified.
To boot, “the authors imply that the failure to put a heavenly ablation lesion can also merely fable for the AFib recurrence,” said Dr. Wang, editor-in-chief of the American Heart Association’s Circulation: Arrhythmia and Electrophysiology. Nonetheless, due to the masses of various capacity variables influencing this possibility, “this is complicated to repeat.”
In the smash, despite a wait on noticed amongst patients with a low level of fibrosis that modified into identified in an as-handled subgroup, “DECAAF II joins the masses of reviews [evaluating the addition of an intervention relative to PVI alone] that occupy no longer executed the foremost endpoint,” Dr. Wang concluded.
An ESC-invited discussant, Christophe Leclercq, MD, chief of cardiology at Centre Hospitalier Universitaire, Rennes, France, made the identical point. He said plenty of old reviews occupy made the conception that of attaining higher ablation to slice AF recurrence “sparkling,” but this “modified into no longer confirmed in DECAAF II.”
He also wouldn’t endorse MRI-guided ablation in resistant AFib amongst patients with early illness.
“There modified into a sure consequence noticed in those with a low stage of fibrosis, but there were also extra complications in those undergoing MRI-guided ablation,” he said.
Dr. Marrouche reviews monetary relationships with Abbott, which offered funding for this ogle. Dr. Wang had no disclosures. Dr. Leclercq reported monetary relationships with Boston Scientific, Medtronic, Sorin Team, and St. Jude Scientific.
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