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