Co-Author(s):
Vanessa Weberndörfer, MD - Fellow cardiac electrophysiology, PhD candidate, Maastricht University Medical Centre
Mindy Vroomen, MD, PhD - Maastricht University Medical Centre
Justin G. Luermans, MD, PhD - Cardiac Electrophysiologist, Maastricht University Medical Centre
Elham Bidar, MD, PhD - Cardiothoracic Surgeon, Maastricht University Medical Centre
Sevasti-Maria Chaldoupi, MD, PhD - Cardiac Electrophysiologist, Maastricht University Medical Centre
Claudia A.J. van der Heijden, MD - Resident, PhD-Candidate, Maastricht University Medical Centre
Kevin Vernooy, MD, PhD - Cardiac Electrophysiologist, Maastricht University Medical Centre
Brigitte Essers, MsC, PhD - Statistician, Maastricht University Medical Centre
Sander MJ van Kuijk, MsC, PhD - Statistician, Maastricht University Medical Centre
Jos G. Maessen, MD, PhD - Head of Cardiothoracic Surgery, Maastricht University Medical Centre
Harry J.G.M. Crijns, MD, PhD - Head of Cardiology, Maastricht University Medical Centre
Laurent Pison, MD, PhD - Cardiac Electrophysiologist, Ziekenhuis Oost Limburg
Mark La Meir, MD, PhD - Head of Cardiac Surgery, UZ Brussels
Bart Maesen, MD, PhD - Cardiothoracic Surgeon, Maastricht University Medical Centre
Maastricht University Medical Centre
Maastricht University Medical Centre Departement of Cardiothoracic Surgery P. Debyelaan 25, 6229 HX Maastricht, Netherlands
Introduction | Objectives: Success rates of conventional transvenous endocardial ablation of non-paroxysmal atrial fibrillation (AF) vary considerably and long-term results are disappointing. Meanwhile, reported results after hybrid ablation, combining thoracoscopic epicardial surgical and endocardial catheter ablation, are more encouraging. Here, we present the results of the HARTCAP-AF, first randomized controlled trial comparing both approaches to test the hypothesis that hybrid ablation is more effective than conventional catheter ablation in patients with non-paroxysmal AF.
Methods: Forty-one patients with non-paroxysmal AF were prospectively randomized to either one-stage hybrid ablation (HA) or conventional catheter ablation (CA). In both groups, pulmonary vein (PV) isolation and a box-lesion consisting of an inferior and superior connecting lesion were created.In HA, endocardial validation of block, and touch-up ablation, if needed, was performed. During follow-up, 24h Holter-monitoring was performed at 3 and 6 months, 7-days Holter-monitoring at 12 months. The primary effectiveness endpoint was freedom from any atrial arrhythmia >5min without the use of class I/III AADs 12-months after ablation. Quality of life (QOL) at 1 year was evaluated using the EQ-5D-5L questionnaire.
Results: At 12 months, freedom from any atrial arrhythmia off AADs was 83% (15/18) after HA and 45% after CA (10/22) (p= 0.015). One patient could not complete the 12m follow-up. There were 3 complications: 1 pericardial tamponade and 1 femoral AV-fistula in HA-group, 1 femoral artery bleeding needing surgical repair in CA-group. There were no deaths or strokes. At 12-months, QOL did not differ significantly between HA and CA (p=0.95). There were less cardiovascular rehospitalizations in HA.
Conclusions: This is the first randomized controlled trial comparing hybrid with conventional ablation in non-paroxysmal AF patients. After 1 year, hybrid ablation resulted in a significantly higher freedom of atrial arrhythmias without increasing the number of associated major adverse events.
AFS2021-04