Time-to-isolation-guided cryoballoon ablation reduces oesophageal and mediastinal alterations detected by endoscopic ultrasound: results of the MADE-PVI trial

Cordes, Frederick C.; Ellermann, Christian; Dechering, Dirk G.; Frommeyer, Gerrit; Kochhäuser, Simon; Lange, Philipp; Pott, Christian; Lenze, Frank; Schmidt, Hartmut; Ullerich, Hansjoerg; Eckardt, Lars

doi:10.1093/europace/euz142

Cited by 23 publications

(28 citation statements)

References 19 publications

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“…The MADE-PVI trial. The design and results of the MADE-PVI study have been reported in detail 6 . In brief, MADE-PVI was a prospective, controlled single-centre trial and conducted to investigate whether the ablation strategy employing 2nd generation cryoballoon had an impact on the occurrence of oesophageal and mediastinal lesions.…”

Section: Methodsmentioning

confidence: 99%

“…In all patients, cryoballoon PVI was performed as described elsewhere in detail 6 . Two different ablation strategies were pursued: either a conventional protocol which consisted of 2 × 180 s freezes or a TTI-guided ablation protocol were employed.…”

Section: Methodsmentioning

confidence: 99%

“…In the recently published MADE-PVI (Mediastino-oesophageal Alterations Detected by Endosonography after PVI) study 6 , the ablation protocol employing 2nd generation cryoballoon had a distinct impact on oesophageal and mediastinal lesions. A time-to-isolation (TTI)-guided ablation protocol (TTI + 120 s) was associated with significantly less mediastinal and oesophageal lesions and might therefore reduce the risk for oesophageal damage compared to a fixed-time freeze application (2 × 180 s).…”

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confidence: 99%

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Pre-procedural proton pump inhibition is associated with fewer peri-oesophageal lesions after cryoballoon pulmonary vein isolation

Cordes

Ellermann

Dechering

et al. 2021

Sci Rep

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Pulmonary vein isolation (PVI) using cryoenergy is safe and efficient for treatment of atrial fibrillation (AF). Pre-existing upper gastrointestinal (GI) pathologies have been shown to increase the risk for AF. Therefore, this study aimed at assessing incidental pathologies of the upper GI tract in patients scheduled for PVI and to analyse the impact of patients’ characteristics on PVI safety outcome. In 71 AF patients, who participated in the MADE-PVI trial, oesophagogastroduodenoscopy and endosonography were prospectively performed directly before and the day after PVI to assess pre-existing upper GI pathologies and post-interventional occurrence of PVI-associated lesions. Subgroup analysis of the MADE-PVI trial identified clinically relevant incidental findings in 53 patients (74.6%) with age > 50 years being a significant risk factor. Pre-existing reflux oesophagitis increased risk for PVI-associated mediastinal oedema, while patients already treated with proton pump inhibitors (PPI) had significantly fewer mediastinal oedema. Our results suggest that AF patients with pre-existing reflux oesophagitis are at higher risk for PVI-associated mediastinal lesions, which is decreased in patients with constant PPI-treatment prior to PVI. Since PVI-associated mediastinal lesions are regarded as surrogate parameter for an increased risk of the fatal complication of an oesophago-atrial fistula, our findings hint at a beneficial effect of pre-interventional prophylactic PPI-treatment to reduce risk for PVI-associated complications.German Clinical Trials Register (DRKS00016006; date of registration: 17/12/2018).

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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confidence: 99%

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Pre-procedural proton pump inhibition is associated with fewer peri-oesophageal lesions after cryoballoon pulmonary vein isolation

Cordes

Ellermann

Dechering

et al. 2021

Sci Rep

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“…In all groups, the catheter setup was complemented by a decapolar coronary sinus catheter and a quadripolar catheter that was positioned in the right ventricle. After ablation, protone pump‐inhibitors were added to the medication of every patient for 4 weeks after ablation to prevent esophageal damage associated to ablation 8‐10 …”

Section: Methodsmentioning

confidence: 99%

Ablation of paroxysmal and persistent atrial fibrillation in the very elderly real‐world data on safety and efficacy

Willy

Wasmer

Dechering

et al. 2020

Clinical Cardiology

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Background: The role and technique of catheter ablation of atrial fibrillation (AF) in the elderly is unclear. While in young patients pulmonary vein isolation (PVI) has evolved as first option, in older patients decision is often made in favor of drugs as higher complication rates and less benefit are suspected. Therefore, data on PVI of paroxysmal and persistent AF in these patients is still sparse but of eminent importance. Hypothesis: PVI is comparably safe in the very elderly with similar recurrence and complication rates. Methods: We enrolled all patients (n = 146) aged >75 years who underwent a first PVI over a period of 10 years (2009-2019) from our prospective single-center ablation registry. Mean follow-up time was 231 ± 399 days. Results: Acute ablation success defined as complete PVI and sinus rhythm at the end of the ablation procedure was high (99%). Severe periprocedural complications occurred in 3.3% (stroke/TIA n = 2; 1.3%; pericardial effusion n = 3; 2%). In 4.6% of patients symptomatic sick-sinus-syndrome was unmasked after PVI resulting in pacemaker implantation. There were no deaths related to PVI. Recurrence rate of symptomatic AF was 37.3% resulting in a Re-PVI and/or substrate ablation in 32 pts (20.9%). During follow-up pacemaker implantation plus atrioventricular node ablation was performed in 10 pts (6.8%). There was a trend toward lower recurrence rates with singleshot devices (cryoballoon, multielectrode phased-radiofrequency ablation catheter) than with point-by-point radiofrequency while complication rates did not differ. Conclusion: PVI for AF is a feasible treatment option also in patients >75 years with a reasonable success and safety profile. Higher success rates occurred in patients treated with a single-shot device as compared to point-by-point ablation. 1 | INTRODUCTION Atrial fibrillation (AF) is the most common atrial arrhythmia. With increasing age AF is becoming clinically manifest in a growing number of patients. In parallel, the need and wish for definitive therapy is growing due to improved ablation techniques with higher success and low-complication rates. Catheter ablation has developed as first line therapy in various arrhythmias. This is reflected in a strengthening of

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“…Our previous study suggested that modified ablation guided by esophageal visualization could decrease the occurrence of EI and there was no significant difference in AF recurrence during 12-month follow-up 10 . www.nature.com/scientificreports www.nature.com/scientificreports/ The latest study indicated that cryoballoon ablation for AF guided by time to PVI reduced the esophageal complications 19 . Consistent with the previous survey on cryoballoon ablation, in which a total of 11 cases of AEF were reported from more than 120,000 cases worldwide 20 , our data supported that cryoballoon ablation had lower incidence of EI, although this is not our main aim.…”

Section: Incidence and Predictors Of Esophageal Injurymentioning

confidence: 99%

Characteristics of Atrial Fibrillation Patients Suffering Esophageal Injury Caused by Ablation for Atrial Fibrillation

Zhang

et al. 2020

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The close proximity of esophagus to the left atrial posterior wall predisposes esophagus to thermal injury during catheter ablation for atrial fibrillation (AF). In this retrospective study, we aimed to investigate risk factors of esophageal injury (EI) caused by catheter ablation for AF. Patients who underwent first-time AF ablation from July 2013 to June 2018 were included. The esophagus was visualized by oral soluble contrast during ablation for all patients and a subset of patients were selected to undergo endoscopic ultrasonography (EUS) to estimate EI post ablation. Degree of EI was categorized as Kansas City classification: type 1: erythema; type 2: ulcers (2a: superficial ulcers; 2b: deep ulcers); type 3: perforation (3a: perforation without communication with the atria; 3b: atrioesophageal fistula [AEF]). Of 3,852 patients, 236 patients (61.5 ± 9.7 years; male, 69%) received EUS (EUS group) and 3616 (63.2 ± 10.9 years; male, 61.1%) without EUS (No-EUS group). In EUS group, EI occurred in 63 patients (type 1 EI in 35 and type 2 EI in 28), and no type 3 EI was observed during follow up. In a multivariable logistic regression analysis, an overlap between the ablation lesion and esophagus was an independent predictor of EI (odds ratio, 21.2; 95% CI: 6.23-72.0; P < 0.001). In No-EUS group, esophagopericardial fistula (EPF; n = 3,0.08%) or AEF (n = 2,0.06%) was diagnosed 4-37 days after ablation. In 3 EPF patients, 2 completely recovered with conservative management and 1 died. Two AEF patients died. Ablation at the vicinity of the esophagus predicts risk of EI. EUS post ablation may prevent the progression of EI and should be considered in management of EI. It remains challenging to identify patients with high risk of EI. Pulmonary vein isolation (PVI) has emerged as a cornerstone therapy for atrial fibrillation (AF) ablation. The close proximity of esophagus to the left atrial posterior wall predisposes esophagus to thermal injury during catheter ablation for AF and Esophageal perforation to the left atrium is a fatal complication 1-5. Introduction of contact force-sensing catheters and cryo-balloon catheters appears to make no change in procedural complication rates for patients undergoing AF ablation 6 , and the utility of contact force-sensing (CF-sensing) catheter may be associated with increased rates of atrioesophageal fistula (AEF) formation 7. A recent study appreciably suggested that postprocedural gastroesophageal endoscopy (GSE) could identify EI, and higher intraesophageal temperature measured by a luminal esophageal temperature probe (LET) was associated with the occurrence of EI 5. However, the protective effect of LET remains controversial since LET itself may also cause EI 8,9 , and routine GSE post AF ablation was not available. Until now, there is no widely accepted approach to minimize esophageal injury (EI) caused by catheter ablation for AF. We sought to identify risk factors of EI caused by ablation for AF, and explore the potential management of EI in this study.

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Time-to-isolation-guided cryoballoon ablation reduces oesophageal and mediastinal alterations detected by endoscopic ultrasound: results of the MADE-PVI trial

Cited by 23 publications

References 19 publications

Pre-procedural proton pump inhibition is associated with fewer peri-oesophageal lesions after cryoballoon pulmonary vein isolation

Pre-procedural proton pump inhibition is associated with fewer peri-oesophageal lesions after cryoballoon pulmonary vein isolation

Ablation of paroxysmal and persistent atrial fibrillation in the very elderly real‐world data on safety and efficacy

Characteristics of Atrial Fibrillation Patients Suffering Esophageal Injury Caused by Ablation for Atrial Fibrillation

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