MEDAFI-Trial (Micro-embolization during ablation of atrial fibrillation): comparison of pulmonary vein isolation using cryoballoon technique vs. radiofrequency energy

Neumann, Thomas; Kuniss, Malte; Conradi, Guido; Janin, Sebastien; Berkowitsch, Alexander; Wójcik, Maciej; Rixe, Johannes; Erkapic, Damir; Zaltsberg, Sergey; Rolf, Andreas; Bachmann, Georg; Dill, Thorsten; Hamm, Christian W.; Pitschner, Heinz-Friedrich

doi:10.1093/europace/euq303

Cited by 104 publications

(106 citation statements)

References 35 publications

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“…Pre-existing lesions were predominantly found in the frontal and parietal lobes, as demonstrated in this sample patient. There were a median of 8 lesions per subject (interquartile range, [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22]. spontaneous; 45% were electrical).…”

Section: Procedural Parametersmentioning

confidence: 99%

Evaluation and Reduction of Asymptomatic Cerebral Embolism in Ablation of Atrial Fibrillation, But High Prevalence of Chronic Silent Infarction

Debruyne¹,

Nardi²,

Deneke³

et al. 2013

Circ: Arrhythmia and Electrophysiology

125

104

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P ulmonary vein (PV) isolation is an effective therapy to alleviate symptoms and restore sinus rhythm in patients with atrial fibrillation (AF).1 However, recent reports have shown that ablation in the left atrium (LA) is associated with new asymptomatic cerebral emboli (ACE) visible on postprocedural diffusion-weighted cerebral MRI.2 The largest such study reported an ACE incidence of 14.2% using openirrigation radiofrequency (RF) catheters.3 Although no patient parameters were correlated with ACE, procedural parameters, such as cardioversion and activated clotting time (ACT) level, were associated with new silent lesions. Smaller subsequent reports with rates ranging from 7% to 12% have similarly implicated procedural factors to increasing ACE incidence, including concomitant diagnostic coronary angiography, 4 total RF duration, 5 and non-PV ablation.6 Editorial see p 827 Clinical Perspective on p 842Two nonrandomized studies found that use of multielectrode RF (MER) ablation was associated with elevated ACE incidence compared with irrigated RF and cryoablation, with a rate as high as 38%. 7,8 Subsequent animal studies showed that both gaseous and solid emboli were generated during both irrigated and MER ablation in the swine LA. 9 Specifically with the circular MER catheter, increased gas emboli were observed during catheter insertion into transseptal sheaths while both embolic and gaseous © 2013 American Heart Association, Inc. Original Article Circ Arrhythm ElectrophysiolBackground-This prospective, multicenter study sought to evaluate the incidence of asymptomatic cerebral emboli (ACE) during ablation of atrial fibrillation (AF) using a multielectrode radiofrequency (MER) system when specific procedural changes were applied. Methods and Results-Sixty subjects (age 60±10 years; 87% paroxysmal; CHADS 2 score, 0.6±0.7) undergoing AF ablation with a circular MER catheter were studied. Three procedural changes were specified: (1) ablation was performed under therapeutic vitamin K antagonist and heparin to maintain activated clotting time >350 seconds; (2) submerged loading of the catheter into the introducer before sheath insertion to minimize air ingress; and (3) either the distal or proximal electrode of the circular MER catheter was deactivated to prevent inadvertent bipolar radiofrequency interaction. MRI was performed <7 days preablation and 2 days postablation. Subjects with new cerebral findings after ablation underwent repeat MRI after 1 month. An acute ACE lesion was defined by a new hyperintensity on diffusion-weighted and fluidattenuated inversion recovery cerebral MRI sequences. Neurological function was evaluated at baseline, postablation, and 1 month. All target pulmonary veins were isolated. In 60% (36/60) of patients, pre-existing cerebral lesions were seen on the preprocedure MRI (8 lesions per subject; interquartile range, 3-22). New postprocedural ACE occurred in only 1/60 patients (incidence, 1.7%; 95% confidence interval, 0.04-8.9), which was no longer visible on MRI after 1 month. Conclusi...

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Section: Procedural Parametersmentioning

confidence: 99%

Evaluation and Reduction of Asymptomatic Cerebral Embolism in Ablation of Atrial Fibrillation, But High Prevalence of Chronic Silent Infarction

Debruyne¹,

Nardi²,

Deneke³

et al. 2013

Circ: Arrhythmia and Electrophysiology

125

104

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“…Patients clinical characteristics such as age 18,19 , previous episodes of AF 20 ] were associated with the occurrence of SCI following transcatheter ablation.…”

Section: Cerebral Ischemia and Atrial Fibrillation Ablationmentioning

confidence: 99%

Illustrated Atlas of Post-AF Ablation Cerebral Abnormalities

Gaïta

Valentini

Corsinovi

et al. 2014

Cardiac Electrophysiology Clinics

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“…19,20 In addition to these clinically apparent ischemic strokes, brain imaging can identify further cerebral damage in patients after LACA (Table 2), similar to those reported after invasive cardiovascular procedures like diagnostic coronary angiography, carotid endarterectomy, or cardiac surgery. [21][22][23][24][25][26] Lickfett et al were the first to demonstrate the utility of diffusionweighted MRI to detect clinically "silent" strokes after LACA. A recent update of their observational cohort study indicated ischemic lesions in 11.3% patients, whereas physical examination revealed a transient reflex abnormality in 1 patient.…”

Section: Laca-associated Strokementioning

confidence: 99%

“…23 Smaller nonrandomized MRI studies reported acute brain lesions in 7.9% to 9.5% of all patients after LACA using radiofrequency or cryoenergy. 24,25 A nonrandomized multicenter study revealed a significantly higher rate of diffusion-weighted MRI lesions after LACA using a multi-electrode nonirrigated pulmonary vein ablation catheter compared to an irrigated-tip radiofrequency catheter or a cryoballoon, respectively (33.3%, 7.4%, or 4.3%). 26 These findings were confirmed by a nonrandomized single-center study demonstrating more diffusion-weighted MRI-detected brain lesions after LACA using a multi-electrode nonirrigated ablation catheter (new lesions in 38.9% of these patients) compared to an irrigated-tip radiofrequency catheter (8.3%) or a cryoballoon (5.6%).…”

Section: Laca-associated Strokementioning

confidence: 99%

“…However, both ablation techniques caused fewer MRI-detected brain lesions than a multi-electrode nonirrigated radiofrequency pulmonary vein ablation catheter. 24,26 Gaita et al 23 found no impact of procedure duration, additional linear lesions or atrial fragmentation, existence of a patent foramen ovale, or a trans-septal approach on MRIdetected cerebral lesions, but the incidence of cerebral embolism significantly correlated to electric cardioversion during LACA. 23 However, a recent multicenter study did not confirm this association.…”

Section: Ablation Strategy Catheter System and Further Technical Dementioning

confidence: 99%

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Left Atrial Catheter Ablation and Ischemic Stroke

Hæusler

Kirchhof

Endres

2012

Stroke

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Abstract-Left atrial catheter ablation (LACA) has become an established therapy to abolish drug-refractory symptomatic paroxysmal and persistent atrial fibrillation. Restoring sinus rhythm by LACA may help to prevent atrial fibrillationrelated strokes, but presently there is no evidence from randomized clinical trials to support this notion. This review summarizes the current knowledge and uncertainties regarding LACA and procedure-related ischemic stroke. In fact, most patients who undergo LACA have a rather low annual stroke risk even when left untreated, whereas LACA imposes a risk of procedure-related stroke of Ϸ0.5% to 1%. In addition, LACA may cause cerebral microemboli, resulting in ischemic lesions. These cerebral lesions, detectable by high-resolution MRI, could contribute to neuropsychological deficits and cognitive dysfunction. Furthermore, recurrent atrial fibrillaton episodes can be detected up to years after LACA and might cause ischemic strokes, especially in those patients in whom therapeutic anticoagulation was discontinued. Further prospective multicenter trials are needed to identify procedure-dependent risk factors for stroke and to optimize postprocedural anticoagulation management. (Stroke. 2012;43:265-270.)

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MEDAFI-Trial (Micro-embolization during ablation of atrial fibrillation): comparison of pulmonary vein isolation using cryoballoon technique vs. radiofrequency energy

Abstract: A considerable portion of patients with AF but without any neurological symptoms had chronic cerebral lesions before PVI. Additional acute lesions could be added after the procedure. Both ablation techniques showed additional cerebral acute lesions with no neurological symptoms after PVI.

Cited by 104 publications

References 35 publications

Evaluation and Reduction of Asymptomatic Cerebral Embolism in Ablation of Atrial Fibrillation, But High Prevalence of Chronic Silent Infarction

Evaluation and Reduction of Asymptomatic Cerebral Embolism in Ablation of Atrial Fibrillation, But High Prevalence of Chronic Silent Infarction

Illustrated Atlas of Post-AF Ablation Cerebral Abnormalities

Left Atrial Catheter Ablation and Ischemic Stroke

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