Silent cerebral lesions and cognitive function after pulmonary vein isolation with an irrigated gold-tip catheter: REDUCE-TE Pilot study

Boris Schmidt, G. Széplaki, B. Merkely, Josef Kautzner, Vincent van Driel, Felix Bourier, Malte Kuniss, Alan Bulava, Georg Nölker, Muchtiar Khan, Thorsten Lewalter, Norbert Klein, Beate Wenzel, Julian K.R. Chun, Dipen Shah

Research output: Contribution to journalArticle

Abstract

Introduction: Stroke is one of the most feared complications during catheter ablation of atrial fibrillation (AF). While symptomatic thromboembolic events are rare, magnetic resonance imaging (MRI) may identify asymptomatic (ie, silent) cerebral lesions (SCLs) following pulmonary vein isolation (PVI) procedures. Methods and Results: The REDUCE-TE Pilot was a prospective multicenter, single-arm observational study investigating the incidence of SCL in patients with symptomatic paroxysmal AF undergoing PVI with a novel gold-tip, externally irrigated ablation catheter. After ablation, cerebral diffusion-weighted MRI and a postablation follow-up were performed at 1 to 3 days after the ablation procedure. A neurocognitive test was done before and after ablation. The primary study endpoint was the occurrence of one or more new SCLs. Secondary study endpoints included neurocognitive status, procedural success rate, and periprocedural complications including symptomatic thromboembolic events. A total of 104 patients were enrolled (69% male, mean age: 61.5 ± 9.7 years, mean CHA 2 DS 2 -VASc score: 1.7 ± 1.2). Postprocedural MRI examination was performed in 97 patients, and in nine of them (9.3%; 95% CI: 4.3-16.9%) a total of 11 SCLs were detected. Univariate analyses did not reveal any significant predictor for new SCLs. Nonsignificant trends were observed for low activated clotting time during ablation and for international normalized ratio value outside the range of 2 to 3 at ablation. There was no evidence of significant deterioration of neurocognitive function after PVI. In four patients, a pericardial tamponade was noted but all patients fully recovered during follow-up. Conclusions: Ablation of AF using a novel gold-tip, externally irrigated ablation catheter, resulted in SCLs in approximately one out of 10 patients without a measurable effect on neurocognitive function.

Original languageEnglish
JournalJournal of Cardiovascular Electrophysiology
DOIs
Publication statusPublished - Jan 1 2019

Fingerprint

Pulmonary Veins
Gold
Cognition
Catheters
Catheter Ablation
Atrial Fibrillation
Magnetic Resonance Imaging
Cardiac Tamponade
Diffusion Magnetic Resonance Imaging
International Normalized Ratio
Observational Studies
Stroke
Incidence

Keywords

  • ablation
  • atrial fibrillation
  • cognitive function
  • gold-tip catheter
  • irrigated catheter
  • pulmonary vein isolation
  • silent cerebral embolism

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Silent cerebral lesions and cognitive function after pulmonary vein isolation with an irrigated gold-tip catheter : REDUCE-TE Pilot study. / Schmidt, Boris; Széplaki, G.; Merkely, B.; Kautzner, Josef; van Driel, Vincent; Bourier, Felix; Kuniss, Malte; Bulava, Alan; Nölker, Georg; Khan, Muchtiar; Lewalter, Thorsten; Klein, Norbert; Wenzel, Beate; Chun, Julian K.R.; Shah, Dipen.

In: Journal of Cardiovascular Electrophysiology, 01.01.2019.

Research output: Contribution to journalArticle

Schmidt, B, Széplaki, G, Merkely, B, Kautzner, J, van Driel, V, Bourier, F, Kuniss, M, Bulava, A, Nölker, G, Khan, M, Lewalter, T, Klein, N, Wenzel, B, Chun, JKR & Shah, D 2019, 'Silent cerebral lesions and cognitive function after pulmonary vein isolation with an irrigated gold-tip catheter: REDUCE-TE Pilot study', Journal of Cardiovascular Electrophysiology. https://doi.org/10.1111/jce.13902
Schmidt, Boris ; Széplaki, G. ; Merkely, B. ; Kautzner, Josef ; van Driel, Vincent ; Bourier, Felix ; Kuniss, Malte ; Bulava, Alan ; Nölker, Georg ; Khan, Muchtiar ; Lewalter, Thorsten ; Klein, Norbert ; Wenzel, Beate ; Chun, Julian K.R. ; Shah, Dipen. / Silent cerebral lesions and cognitive function after pulmonary vein isolation with an irrigated gold-tip catheter : REDUCE-TE Pilot study. In: Journal of Cardiovascular Electrophysiology. 2019.
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abstract = "Introduction: Stroke is one of the most feared complications during catheter ablation of atrial fibrillation (AF). While symptomatic thromboembolic events are rare, magnetic resonance imaging (MRI) may identify asymptomatic (ie, silent) cerebral lesions (SCLs) following pulmonary vein isolation (PVI) procedures. Methods and Results: The REDUCE-TE Pilot was a prospective multicenter, single-arm observational study investigating the incidence of SCL in patients with symptomatic paroxysmal AF undergoing PVI with a novel gold-tip, externally irrigated ablation catheter. After ablation, cerebral diffusion-weighted MRI and a postablation follow-up were performed at 1 to 3 days after the ablation procedure. A neurocognitive test was done before and after ablation. The primary study endpoint was the occurrence of one or more new SCLs. Secondary study endpoints included neurocognitive status, procedural success rate, and periprocedural complications including symptomatic thromboembolic events. A total of 104 patients were enrolled (69{\%} male, mean age: 61.5 ± 9.7 years, mean CHA 2 DS 2 -VASc score: 1.7 ± 1.2). Postprocedural MRI examination was performed in 97 patients, and in nine of them (9.3{\%}; 95{\%} CI: 4.3-16.9{\%}) a total of 11 SCLs were detected. Univariate analyses did not reveal any significant predictor for new SCLs. Nonsignificant trends were observed for low activated clotting time during ablation and for international normalized ratio value outside the range of 2 to 3 at ablation. There was no evidence of significant deterioration of neurocognitive function after PVI. In four patients, a pericardial tamponade was noted but all patients fully recovered during follow-up. Conclusions: Ablation of AF using a novel gold-tip, externally irrigated ablation catheter, resulted in SCLs in approximately one out of 10 patients without a measurable effect on neurocognitive function.",
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T2 - REDUCE-TE Pilot study

AU - Schmidt, Boris

AU - Széplaki, G.

AU - Merkely, B.

AU - Kautzner, Josef

AU - van Driel, Vincent

AU - Bourier, Felix

AU - Kuniss, Malte

AU - Bulava, Alan

AU - Nölker, Georg

AU - Khan, Muchtiar

AU - Lewalter, Thorsten

AU - Klein, Norbert

AU - Wenzel, Beate

AU - Chun, Julian K.R.

AU - Shah, Dipen

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Introduction: Stroke is one of the most feared complications during catheter ablation of atrial fibrillation (AF). While symptomatic thromboembolic events are rare, magnetic resonance imaging (MRI) may identify asymptomatic (ie, silent) cerebral lesions (SCLs) following pulmonary vein isolation (PVI) procedures. Methods and Results: The REDUCE-TE Pilot was a prospective multicenter, single-arm observational study investigating the incidence of SCL in patients with symptomatic paroxysmal AF undergoing PVI with a novel gold-tip, externally irrigated ablation catheter. After ablation, cerebral diffusion-weighted MRI and a postablation follow-up were performed at 1 to 3 days after the ablation procedure. A neurocognitive test was done before and after ablation. The primary study endpoint was the occurrence of one or more new SCLs. Secondary study endpoints included neurocognitive status, procedural success rate, and periprocedural complications including symptomatic thromboembolic events. A total of 104 patients were enrolled (69% male, mean age: 61.5 ± 9.7 years, mean CHA 2 DS 2 -VASc score: 1.7 ± 1.2). Postprocedural MRI examination was performed in 97 patients, and in nine of them (9.3%; 95% CI: 4.3-16.9%) a total of 11 SCLs were detected. Univariate analyses did not reveal any significant predictor for new SCLs. Nonsignificant trends were observed for low activated clotting time during ablation and for international normalized ratio value outside the range of 2 to 3 at ablation. There was no evidence of significant deterioration of neurocognitive function after PVI. In four patients, a pericardial tamponade was noted but all patients fully recovered during follow-up. Conclusions: Ablation of AF using a novel gold-tip, externally irrigated ablation catheter, resulted in SCLs in approximately one out of 10 patients without a measurable effect on neurocognitive function.

AB - Introduction: Stroke is one of the most feared complications during catheter ablation of atrial fibrillation (AF). While symptomatic thromboembolic events are rare, magnetic resonance imaging (MRI) may identify asymptomatic (ie, silent) cerebral lesions (SCLs) following pulmonary vein isolation (PVI) procedures. Methods and Results: The REDUCE-TE Pilot was a prospective multicenter, single-arm observational study investigating the incidence of SCL in patients with symptomatic paroxysmal AF undergoing PVI with a novel gold-tip, externally irrigated ablation catheter. After ablation, cerebral diffusion-weighted MRI and a postablation follow-up were performed at 1 to 3 days after the ablation procedure. A neurocognitive test was done before and after ablation. The primary study endpoint was the occurrence of one or more new SCLs. Secondary study endpoints included neurocognitive status, procedural success rate, and periprocedural complications including symptomatic thromboembolic events. A total of 104 patients were enrolled (69% male, mean age: 61.5 ± 9.7 years, mean CHA 2 DS 2 -VASc score: 1.7 ± 1.2). Postprocedural MRI examination was performed in 97 patients, and in nine of them (9.3%; 95% CI: 4.3-16.9%) a total of 11 SCLs were detected. Univariate analyses did not reveal any significant predictor for new SCLs. Nonsignificant trends were observed for low activated clotting time during ablation and for international normalized ratio value outside the range of 2 to 3 at ablation. There was no evidence of significant deterioration of neurocognitive function after PVI. In four patients, a pericardial tamponade was noted but all patients fully recovered during follow-up. Conclusions: Ablation of AF using a novel gold-tip, externally irrigated ablation catheter, resulted in SCLs in approximately one out of 10 patients without a measurable effect on neurocognitive function.

KW - ablation

KW - atrial fibrillation

KW - cognitive function

KW - gold-tip catheter

KW - irrigated catheter

KW - pulmonary vein isolation

KW - silent cerebral embolism

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