Publications by authors named "Helmut Puererfellner"

9 Publications

  • Page 1 of 1

Pulmonary Vein Stenosis After Atrial Fibrillation Ablation: Insights From the ADVICE Trial.

Can J Cardiol 2020 12 3;36(12):1965-1974. Epub 2020 Nov 3.

Montreal Health Innovations Coordinating Center (MHICC), Montreal, Quebec, Canada.

Background: Pulmonary vein (PV) stenosis is a complication of atrial fibrillation (AF) ablation. The incidence of PV stenosis after routine post-ablation imaging remains unclear and is limited to single-centre studies. Our objective was to determine the incidence and predictors of PV stenosis following circumferential radiofrequency ablation in the multicentre Adenosine Following Pulmonary Vein Isolation to Target Dormant Conduction Elimination (ADVICE) trial.

Methods: Patients with symptomatic AF underwent circumferential radiofrequency ablation in one of 13 trial centres. Computed tomographic (CTA) or magnetic resonance (MRA) angiography was performed before ablation and 90 days after ablation. Two blinded reviewers measured PV diameters and areas. PVs with stenosis were classified as severe (> 70%), moderate (50%-70%), or mild (< 50%). Predictors of PV stenosis were identified by means of multivariable logistic regression.

Results: A total of 197 patients (median age 59.5 years, 29.4% women) were included in this substudy. PV stenosis was identified in 41 patients (20.8%) and 47 (8.2%) of 573 ablated PVs. PV stenosis was classified as mild in 42 PVs (7.3%) and moderate in 5 PVs (0.9%). No PVs had severe stenosis. Both cross-sectional area and diameter yielded similar classifications for severity of PV stenosis. Diabetes was associated with a statistically significant increased risk of PV stenosis (OR 4.91, 95% CI 1.45-16.66).

Conclusions: In the first systematic multicentre evaluation of post-ablation PV stenosis, no patient acquired severe PV stenosis. Although the results are encouraging for the safety of AF ablation, 20.8% of patients had mild or moderate PV stenosis, in which the long-term effects are unknown.
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December 2020

Effect of PR interval and pacing mode on persistent atrial fibrillation incidence in dual chamber pacemaker patients: a sub-study of the international randomized MINERVA trial.

Europace 2019 Apr;21(4):636-644

Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, S.Orsola-Malpighi University Hospital, Bologna, Italy.

Aims: Per standard of care, dual-chamber pacemakers are programmed in DDDR mode with fixed atrioventricular (AV) delay or with long AV delay to minimize ventricular pacing. We aimed to evaluate whether the PR interval may be a specific criterion of choice between standard DDDR, to preserve AV synchrony in long PR patients, and managed ventricular pacing (MVP), to avoid ventricular desynchronization imposed by right ventricle apical pacing, in short PR patients.

Methods And Results: In the MINERVA trial, 1166 patients were randomized to Control DDDR, MVP, or atrial anti-tachycardia pacing plus MVP (DDDRP + MVP). We evaluated the interaction of PR interval with pacing mode by comparing the risk of atrial fibrillation (AF) longer than 7 consecutive days as a function of PR interval. Out of 906 patients with available data, the median PR interval was 180 ms. The PR interval was found to significantly (P = 0.012) interact with pacing mode for AF incidence: the risk of AF > 7 days was lower [hazard ratio (HR) 0.58, 95% confidence interval (95% CI) 0.34-0.99; P = 0.047] in patients with short PR (shorter than median PR) if programmed in MVP mode compared with DDDR mode and it was lower (HR 0.65, 95% CI 0.43-0.99; P = 0.049) in patients with long PR (equal to or longer than median PR) if programmed in DDDR mode compared with MVP.

Conclusion: Our data show that PR interval may be used as a selection criterion to identify the optimal physiological pacing mode. Persistent AF incidence was lower in short PR patients treated by right ventricular pacing minimization and in long PR patients treated by standard dual-chamber pacing.
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April 2019

Screening for Atrial Fibrillation: A Report of the AF-SCREEN International Collaboration.

Circulation 2017 05;135(19):1851-1867

From Heart Research Institute, Charles Perkins Centre, and Concord Hospital Cardiology, University of Sydney, Australia (B.F.); St Georges Hospital, London, UK (J.C.); Johns Hopkins University, Baltimore, MD (H.C.); Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada (J.S.H., D.C.); Karolinska Institute, Stockholm, Sweden (M.R., J.E., L.F., E.S.); The Shanghai Institute of Hypertension, Ruijin Hospital, Jiaotong University School of Medicine, China (J.W.); Brigham and Womens Hospital, Harvard Medical School, Boston, MA (C.M.A.); The George Institute for Global Health, Sydney, Australia (C.S.A.); Barts Health NHS Trust, London, UK (S.A.); National Heart, Lung, and Blood Institute and Boston University's Framingham Heart Study, MA (E.J.B.); University of Modena and Reggio Emilia, Italy (G.B.); Klinikum Coburg, Germany (J.B.); Odense University Hospital, Denmark (A.B.); Cardiovascular Research Centre, National Yang-Ming University, Taipei, Taiwan (T.- F.C.); University Hospital, Basel, Switzerland (D.C.); Université François Rabelais, Tours, France (L.F.); University of Birmingham, UK (D.A.F.); Mayo Clinic College of Medicine, Rochester, MN (B.J.G.); University of Toronto, Ontario, Canada (D.J.G., A.V.); Hackensack University Medical Centre, NJ (T.V.G.); Poche Centre, University of Sydney, Australia (K.G.); University of Western Australia, Perth (G.J.H.); Trinity College, Dublin, Ireland (J.H.); Royal Perth Hospital, University of Western Australia (G.S.H.);, Dallas, TX (M.T.H.); Weill Cornell Medical College, New York (H.K.); Institute of Cardiovascular Sciences, University of Birmingham, UK (P.K.); SWBH and UHB NHS trusts, Birmingham, UK (P.K.); AFNET, Muenster, Germany (P.K.); Lankenau Institute for Medical Research, Wynnewood, OK (P.R.K.); University Hospital of Zurich, Switzerland (D.K.); Chinese University of Hong Kong (V.W.Y.L., B.P.Y.); University of Linköping, Sweden (L.-A.L.); University of Birmingham, UK; Aalborg University, Denmark (G.Y.H.L.); Arrhythmia Alliance, London, UK (T.L.); Charles Perkins Centre, University of Sydney, Australia (N.L.); Cliniques du Sud Luxembourg, Arlon, Belgium (G.H.M.); Institute for Epidemiology Statistics and Informatics, Frankfurt, Germany (C.M.); Edinburgh Napier University, UK (L.N.); Charles Perkins Centre, University of Sydney, Australia (J.O.); Duke University, Durham, NC (J.P.P.); University of Auckland, New Zealand (K.P.); University of Belgrade, Serbia (T.S.P.); KH der Elisabethinen, Ordensklinikum Linz, Austria (H.P.); University of Groningen, University Medical Centre Groningen, The Netherlands (M.R.); University of Alberta, Edmonton, Canada (R.K.S.); University Heart Centre, Hamburg, Germany (R.B.S.); The University of Hong Kong (C.-W.S.); Scripps Translational Science Institute, San Diego, CA (S.S.); Rigshospitalet, The Heart Centre, University of Copenhagen, Denmark (J.H.S.); Ospedale dell'Angelo Venice-Mestre, Venice, Italy (S.T.); Martini Hospital, Groningen, The Netherlands (R.G.T.); Stanford University, CA (M.P.T.); VA Palo Alto Health Care System, CA (M.P.T.); The Department of Medical Research, Bærum Hospital, Rud, Norway (A.T.); Department of General Practice, Academic Medical Center, Amsterdam, The Netherlands (S.B.U.); University of Groningen, University Medical Centre Groningen, The Netherlands (I.C.V.G.); and University of Göttingen, Germany (R.W.).

Approximately 10% of ischemic strokes are associated with atrial fibrillation (AF) first diagnosed at the time of stroke. Detecting asymptomatic AF would provide an opportunity to prevent these strokes by instituting appropriate anticoagulation. The AF-SCREEN international collaboration was formed in September 2015 to promote discussion and research about AF screening as a strategy to reduce stroke and death and to provide advocacy for implementation of country-specific AF screening programs. During 2016, 60 expert members of AF-SCREEN, including physicians, nurses, allied health professionals, health economists, and patient advocates, were invited to prepare sections of a draft document. In August 2016, 51 members met in Rome to discuss the draft document and consider the key points arising from it using a Delphi process. These key points emphasize that screen-detected AF found at a single timepoint or by intermittent ECG recordings over 2 weeks is not a benign condition and, with additional stroke factors, carries sufficient risk of stroke to justify consideration of anticoagulation. With regard to the methods of mass screening, handheld ECG devices have the advantage of providing a verifiable ECG trace that guidelines require for AF diagnosis and would therefore be preferred as screening tools. Certain patient groups, such as those with recent embolic stroke of uncertain source (ESUS), require more intensive monitoring for AF. Settings for screening include various venues in both the community and the clinic, but they must be linked to a pathway for appropriate diagnosis and management for screening to be effective. It is recognized that health resources vary widely between countries and health systems, so the setting for AF screening should be both country- and health system-specific. Based on current knowledge, this white paper provides a strong case for AF screening now while recognizing that large randomized outcomes studies would be helpful to strengthen the evidence base.
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May 2017

Adenosine-guided pulmonary vein isolation for the treatment of paroxysmal atrial fibrillation: an international, multicentre, randomised superiority trial.

Lancet 2015 Aug 23;386(9994):672-9. Epub 2015 Jul 23.

Montreal Heart Institute and Montreal Health Innovations Coordinating Centre, Department of Medicine, Université de Montréal, Montreal, QC, Canada.

Background: Catheter ablation is increasingly used to manage atrial fibrillation, but arrhythmia recurrences are common. Adenosine might identify pulmonary veins at risk of reconnection by unmasking dormant conduction, and thereby guide additional ablation to improve arrhythmia-free survival. We assessed whether adenosine-guided pulmonary vein isolation could prevent arrhythmia recurrence in patients undergoing radiofrequency catheter ablation for paroxysmal atrial fibrillation.

Methods: We did this randomised trial at 18 hospitals in Australia, Europe, and North America. We enrolled patients aged older than 18 years who had had at least three symptomatic atrial fibrillation episodes in the past 6 months, and for whom treatment with an antiarrhythmic drug failed. After pulmonary vein isolation, intravenous adenosine was administered. If dormant conduction was present, patients were randomly assigned (1:1) to additional adenosine-guided ablation to abolish dormant conduction or to no further ablation. If no dormant conduction was revealed, randomly selected patients were included in a registry. Patients were masked to treatment allocation and outcomes were assessed by a masked adjudicating committee. Patients were followed up for 1 year. The primary outcome was time to symptomatic atrial tachyarrhythmia after a single procedure in the intention-to-treat population. The trial is registered with, number NCT01058980.

Findings: Adenosine unmasked dormant pulmonary vein conduction in 284 (53%) of 534 patients. 102 (69·4%) of 147 patients with additional adenosine-guided ablation were free from symptomatic atrial tachyarrhythmia compared with 58 (42·3%) of 137 patients with no further ablation, corresponding to an absolute risk reduction of 27·1% (95% CI 15·9-38·2; p<0·0001) and a hazard ratio of 0·44 (95% CI 0·31-0·64; p<0·0001). Of 115 patients without dormant pulmonary vein conduction, 64 (55·7%) remained free from symptomatic atrial tachyarrhythmia (p=0·0191 vs dormant conduction with no further ablation). Occurrences of serious adverse events were similar in each group. One death (massive stroke) was deemed probably related to ablation in a patient included in the registry.

Interpretation: Adenosine testing to identify and target dormant pulmonary vein conduction during catheter ablation of atrial fibrillation is a safe and highly effective strategy to improve arrhythmia-free survival in patients with paroxysmal atrial fibrillation. This approach should be considered for incorporation into routine clinical practice.

Funding: Canadian Institutes of Health Research, St Jude Medical, Biosense-Webster, and M Lachapelle (Montreal Heart Institute Foundation).
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August 2015

Optimizing radiofrequency ablation of paroxysmal and persistent atrial fibrillation by direct catheter force measurement-a case-matched comparison in 198 patients.

Pacing Clin Electrophysiol 2015 Feb 2;38(2):201-8. Epub 2014 Dec 2.

Department of Cardiology, Elisabethinen University Teaching Hospital of the Universities Innsbruck, Vienna, Graz, Linz, Austria.

Background: Sufficient electrode-tissue contact is crucial for adequate lesion formation in radiofrequency catheter ablation (RFCA).

Objective: We assessed the impact of direct catheter force measurement on acute procedural parameters and outcome of RFCA for paroxysmal and persistent atrial fibrillation (AF).

Methods: Ninety-nine consecutive patients (70% men) with paroxysmal (63.6%) or persistent AF underwent left atrial RFCA using a 3.5-mm open-irrigated-tip (OIT) catheter with contact force measurement capabilities (group 1). For comparison a case-matched cohort with standard OIT catheters was used (99 patients; group 2). Case matching included gender, type of AF, number or RFCA procedures, and type of procedure.

Results: Procedural data showed a significant decline in radiofrequency ablation time from 52 ± 20 to 44 ± 16 minutes (P = 0.003) with a remarkable mean reduction in overall procedure time of 34 minutes (P = 0.0001; 225.8 ± 53.1 vs 191.9 ± 53.3 minutes). In parallel, the total fluoroscopy time could be significantly reduced from 28.5 ± 11.0 to 19.9 ± 9.3 minutes (P = 0.0001) as well as fluoroscopy dose from 74.1 ± 58.0 to 56.7 ± 38.9 Gy/cm(2) (P = 0.016). Periprocedural complications were similar in both groups.

Conclusions: The use of contact force sensing technology is able to significantly reduce ablation, procedure, and fluoroscopy times as well as dose in RFCA of AF in a mixed case-matched group of paroxysmal and persistent AF. Energy delivery is substantially reduced by avoiding radiofrequency ablation in positions with insufficient surface contact. Additionally 12-month outcome data showed increased efficacy. Such time saving and equally safe technology may have a relevant impact on laboratory management and increased cost effectiveness.
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February 2015

Supraventricular bigeminus.

J Electrocardiol 2012 Nov-Dec;45(6):797-8

Department of Cardiology and Electrophysiology, Elisabethinen University Teaching Hospital, Universities of Innsbruck and Graz, Fadingerstrasse 1, 4010 Linz, Austria.

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May 2013

Adenosine following pulmonary vein isolation to target dormant conduction elimination (ADVICE): methods and rationale.

Can J Cardiol 2012 Mar-Apr;28(2):184-90. Epub 2012 Jan 2.

Montreal Heart Institute and Montreal Heart Institute Coordinating Centre, Université de Montréal, Montréal, Québec, Canada.

Background: Pulmonary vein (PV) isolation (PVI) has emerged as an effective therapy for paroxysmal atrial fibrillation (AF). However, AF recurs in up to 50% of patients, generally because of recovery of PV conduction. Adenosine given during the initial procedure may reveal dormant PV conduction, thereby identifying the need for additional ablation, leading to improved outcomes. The Adenosine Following Pulmonary Vein Isolation to Target Dormant Conduction Elimination (ADVICE) study is a prospective multicentre randomized trial assessing the impact of adenosine-guided PVI in preventing AF recurrences.

Methods: Patients undergoing a first PVI procedure for paroxysmal AF will be recruited. After standard PVI is completed, all patients will receive intravenous adenosine in an attempt to unmask dormant conduction. If dormant conduction is elicited, patients will be randomized to no further ablation (control group) or additional adenosine-guided ablation until dormant conduction is abolished. If no dormant conduction is revealed, randomly selected patients will be followed in a registry. The primary outcome is time to first documented symptomatic AF recurrence. Assuming that dormant conduction is present in 50% of patients post PVI and symptomatic AF recurs in 45% of controls, 244 patients with dormant conduction will be required to obtain > 90% power to detect a difference of 20%. Thus, a total of 488 patients will be enrolled and followed for 12 months.

Conclusion: The ADVICE trial will assess whether a PVI strategy incorporating elimination of dormant conduction unmasked by intravenous adenosine will decrease the rate of recurrent symptomatic AF compared with standard PVI.
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July 2012

Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment.

Heart Rhythm 2011 Jan 7;8(1):65-73. Epub 2010 Oct 7.

Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA.

Background: Magnetic resonance imaging (MRI) of pacemaker patients is contraindicated due to documented potential risks to the patient from hazardous interactions between the MRI and pacemaker system.

Objective: The purpose of this prospective, randomized, controlled, worldwide clinical trial was to evaluate the safety and effectiveness of a pacemaker system designed for safe use in MRI for any bradycardia indicated patient.

Methods: Patients (n = 464) were randomized to undergo an MRI scan between 9 and 12 weeks postimplant (MRI group, n = 258) or not to undergo MRI (control group, n = 206) after successful implantation of the specially designed dual-chamber pacemaker and leads. Patients were monitored for arrhythmias, symptoms, and pacemaker system function during 14 nonclinically indicated relevant brain and lumbar MRI sequences. Sequences were performed at 1.5 T and included scans with high radiofrequency power deposition and/or high gradient dB/dt exposure. Clinical evaluation of the pacemaker system function occurred immediately before and after MRI, 1 week and 1 month post-MRI, and at corresponding times for the control group. Primary endpoints for safety analyzed the MRI procedure complication-free rate and for effectiveness compared capture and sensing performance between MRI and control groups.

Results: No MRI-related complications occurred during or after MRI, including sustained ventricular arrhythmias, pacemaker inhibition or output failures, electrical resets, or other pacemaker malfunctions. Pacing capture threshold and sensed electrogram amplitude changes were minimal and similar between study groups.

Conclusion: This trial documented the ability of this pacemaker system to be exposed in a controlled fashion to MRI in a 1.5 T scanner without adverse impact on patient outcomes or pacemaker system function.
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January 2011

The MINERVA study design and rationale: a controlled randomized trial to assess the clinical benefit of minimizing ventricular pacing in pacemaker patients with atrial tachyarrhythmias.

Am Heart J 2008 Sep;156(3):445-51

Philipps University Marburg, Marburg, Germany.

Background: Dual-chamber (DDD) pacing has generally been regarded as "physiologic pacing" and therefore expected to be superior to ventricular pacing. Major randomized trials have so far failed to demonstrate significant reductions in the incidences of mortality, stroke, and heart failure. It has been shown that unnecessary ventricular pacing in patients with sinus node dysfunction or only intermittent atrioventricular block is associated with ventricular desynchronization and increased risk of atrial tachyarrhythmias (ATA).

Methods: The MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure (MINERVA) study is a prospective, multi-center, randomized, international, single-blind, controlled trial designed to determine whether physiologic pacing through the managed ventricular pacing (MVP) algorithm combined with preventive atrial pacing (PAP) and atrial antitachycardia pacing (ATP) is superior to standard DDD pacing in terms of 2-year reduction in death, permanent ATA, and cardiovascular hospitalizations. Patients with standard class I or II indications for permanent DDD pacing and history of ATA will receive a Medtronic EnRhythm implantable pacemaker (Medtronic, Minneapolis, MN). After a 1-month run-in period, patients will be randomized in a 1:1:1 manner to the DDD (control group, all OFF), the DDDRP (MVP + PAP + ATP ON), and the MVP group (only MVP ON). Up to 1,300 patients will be included in approximately 70 centers in Europe, the Middle East, and Asia.

Conclusions: The MINERVA study will make an important contribution to the management of patients with paroxysmal ATA and accepted indications for dual-chamber pacemaker implantation by determining whether physiologic pacing combined with PAP and ATP is superior to standard DDD pacing in terms of reduction of mortality, incidence of permanent ATA, and cardiovascular hospitalizations.
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September 2008