Publications by authors named "Laurent Macle"

195 Publications

Prevalence and Outcome of Early Recurrence of Atrial Tachyarrhythmias in the Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation (CIRCA-DOSE) Study.

Heart Rhythm 2021 Jun 11. Epub 2021 Jun 11.

Heart Rhythm Services, Department of Medicine, University of British Columbia, Canada; Center for Cardiovascular Innovation, Vancouver, Canada; Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada. Electronic address:

Background: Early recurrence of atrial tachyarrhythmia (ERAT) is common after pulmonary vein isolation (PVI) and has been associated with an increased risk of late AF recurrence.

Objective: We sought to determine the incidence and outcomes of patients experiencing ERAT after PVI using advanced-generation ablation technologies.

Methods: This is a prespecified substudy of the CIRCA-DOSE trial, a prospective, randomized, multicenter study comparing PVI with contact force-guided radiofrequency ablation to secondary-generation cryoballoon ablation for paroxysmal AF. All study patients received an implantable cardiac monitor to allow continuous rhythm monitoring. ERAT was defined as any recurrent atrial tachyarrhythmia within the first 90 days after AF ablation.

Results: ERAT occurred in 61% of the 346 patients at a median of 12 days (range 1-90 days) after ablation. ERAF was a significant predictor of late recurrence (60.1% with ER vs 25.9% without ER;p<0.001) and symptomatic atrial tachyarrhythmia (31.6% with ERAF vs. 6.7% without ERAF;p<0.001). Receiver operating curve analyses revealed a strong correlation between ERAF timing and burden and late recurrence. Multivariate analysis identified ER timing (HR 2.90; 95%CI1.41-5.95;p=0.004) and burden (HR 1.05 per 1% ER burden, 95%CI1.04-1.07;p<0.001) as strong independent predictors of late recurrence. The incidence rate, timing, burden, and prognostic significance of ER did not differ between the study groups.

Conclusions: Early recurrence of atrial tachyarrhythmia remains common after PVI despite use of advanced-generation ablation technologies. Early AF recurrence beyond 3 weeks after ablation is associated with increased risk of late recurrence.
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http://dx.doi.org/10.1016/j.hrthm.2021.06.1172DOI Listing
June 2021

Response to letter to the Editor CJC-D-21-00657R1.

Can J Cardiol 2021 May 17. Epub 2021 May 17.

Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada.

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http://dx.doi.org/10.1016/j.cjca.2021.05.005DOI Listing
May 2021

A randomized, controlled comparison of electrical versus pharmacological cardioversion for emergency department patients with acute atrial flutter.

CJEM 2021 May 18;23(3):314-324. Epub 2021 Jan 18.

Department of Emergency Medicine, University of Ottawa, Ottawa, ON, Canada.

Background: Acute atrial flutter has one-tenth the prevalence of acute atrial fibrillation in the emergency department (ED) but shares many management strategies. Our aim was to compare conversion from acute atrial flutter to sinus rhythm between pharmacological cardioversion followed by electrical cardioversion (Drug-Shock), and electrical cardioversion alone (Shock-Only).

Methods: We conducted a randomized, blinded, placebo-controlled comparison of attempted pharmacological cardioversion with IV procainamide followed by electrical cardioversion if necessary, and placebo infusion followed by electrical cardioversion. We enrolled stable patients with a primary diagnosis of acute acute atrial flutter at 11 academic EDs. The primary outcome was conversion to normal sinus rhythm.

Findings: From July 2013 to October 2018, we enrolled 76 patients, and none were lost to follow-up. Comparing the Drug-Shock to the Shock-Only group, conversion to sinus rhythm occurred in 33 (100%) versus 40 (93%) (absolute difference 7.0%; 95% CI - 0.6 to 14.6; P = 0.25). Median time to conversion from start of infusion in the Drug-Shock group was 24 min (IQR 21-82) but only 9 (27%) cases were converted with IV procainamide. Patients in both groups had similar outcomes at 14 days; there were no strokes or deaths.

Interpretation: This trial found that the Drug-Shock strategy is potentially superior but that either approach to immediate rhythm control in the ED for patients with acute acute atrial flutter is highly effective, rapid, and safe in restoring sinus rhythm and allowing patients to go home and return to normal activities. Unlike the case of atrial fibrillation, we found that IV procainamide alone was infrequently effective.
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http://dx.doi.org/10.1007/s43678-020-00067-7DOI Listing
May 2021

Canadian national electrophysiology ablation registry report 2011-2016.

BMC Health Serv Res 2021 May 6;21(1):435. Epub 2021 May 6.

Sunnybrook Health Sciences Centre, University of Toronto, 890 Sheppard Avenue West, Ontario, M4N 3M5, Toronto, Canada.

Background/purpose: Interventional cardiac electrophysiology (EP) is a rapidly evolving field in Canada; a nationwide registry was established in 2011 to conduct a periodic review of resource allocation.

Methods: The registry collects annual data on EP lab infrastructure, imaging, tools, human resources, procedural volumes, success rates, and wait times. Leading physicians from each EP lab were contacted electronically; participation was voluntary.

Results: All Canadian EP centres were identified (n = 30); 50 and 45 % of active centres participated in the last 2 instalments of the registry. A mean of 508 ± 270 standard and complex catheter ablation procedures were reported annually for 2015-2016 by all responding centres. The most frequently performed ablation targets atrial fibrillation (PVI) arrhythmia accounting for 36 % of all procedures (mean = 164 ± 85). The number of full time physicians ranges between 1 and 7 per centre, (mean = 4). The mean wait time to see an electrophysiologist for an initial non-urgent consult is 23 weeks. The wait time between an EP consult and ablation date is 17.8 weeks for simple ablation, and 30.1 weeks for AF ablation. On average centres have 2 (range: 1-4) rooms equipped for ablations; each centre uses the EP lab an average of 7 shifts per week. While diagnostic studies and radiofrequency ablations are performed in all centres, point-by-point cryoablation is available in 85 % centres; 38 % of the respondents use circular ablation techniques.

Conclusions: This initiative provides contemporary data on invasive electrophysiology lab practices. The EP registry provides activity benchmarks on national trends and practices.
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http://dx.doi.org/10.1186/s12913-021-06441-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8101210PMC
May 2021

Autonomic Alterations After Pulmonary Vein Isolation in the CIRCA-DOSE (Cryoballoon vs Irrigated Radiofrequency Catheter Ablation) Study.

J Am Heart Assoc 2021 Feb 26;10(5):e018610. Epub 2021 Feb 26.

Center for Cardiovascular Innovation Vancouver Canada.

Background The natural history of autonomic alterations following catheter ablation of drug-refractory paroxysmal atrial fibrillation is poorly defined, largely because of the historical reliance on non-invasive intermittent rhythm monitoring for outcome ascertainment. Methods and Results The study included 346 patients with drug-refractory paroxysmal atrial fibrillation undergoing pulmonary vein isolation using contemporary advanced-generation ablation technologies. All patients underwent insertion of a Reveal LINQ (Medtronic) implantable cardiac monitor before ablation. The implantable cardiac monitor continuously recorded physical activity, heart rate variability (measured as the SD of the average normal-to-normal), daytime heart rate, and nighttime heart rate. Longitudinal autonomic data in the 2-month period leading up to the date of ablation were compared with the period from 91 to 365 days following ablation. Following ablation there was a significant decrease in SD of the average normal-to-normal (mean difference versus baseline of 19.3 ms; range, 12.9-25.7; <0.0001), and significant increases in daytime and nighttime heart rates (mean difference versus baseline of 9.6 bpm; range, 7.4-11.8; <0.0001, and 7.4 bpm; range, 5.4-9.3; <0.0001, respectively). Patients free of arrhythmia recurrence had significantly faster daytime (11±11 versus 8±12 bpm, =0.001) and nighttime heart rates (8±9 versus 6±8 bpm, =0.049), but no difference in SD of the average normal-to-normal (=0.09) compared with those with atrial fibrillation recurrence. Ablation technology and cryoablation duration did not influence these autonomic nervous system effects. Conclusions Pulmonary vein isolation results in significant sustained changes in the heart rate parameters related to autonomic function. These changes are correlated with procedural outcome and are independent of the ablation technology used. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01913522.
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http://dx.doi.org/10.1161/JAHA.120.018610DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8174287PMC
February 2021

Positive Clinical Benefit on Patient Care, Quality of Life, and Symptoms After Contact Force-Guided Radiofrequency Ablation in Persistent Atrial Fibrillation: Analyses From the PRECEPT Prospective Multicenter Study.

Circ Arrhythm Electrophysiol 2021 01 8;14(1):e008867. Epub 2020 Dec 8.

Massachusetts General Hospital, Boston (M.M.).

Background: There is limited evidence on the long-term clinical benefits of catheter ablation in patients with persistent atrial fibrillation.

Methods: PRECEPT was a prospective, multicenter, single-arm Food and Drug Administration-regulated investigational device exemption clinical study. Patients were followed up to 15 months after ablation. Outcomes included use of antiarrhythmic drugs, rate of cardioversions and cardiovascular hospitalization, Atrial Fibrillation Effect on Quality-of-Life score, and Canadian Cardiovascular Society Severity of Atrial Fibrillation score.

Results: A total of 333 enrolled persistent atrial fibrillation patients underwent ablation. The cardioversion rate decreased by 83% at the 9- to 15-month follow-up. Antiarrhythmic drug utilization decreased by 69% at 12 to 15 months post-ablation. The Kaplan-Meier estimate of freedom from cardiovascular hospitalization was 84.2% (95% CI, 80.2%-88.2%) at 15 months. Consistent improvements in mean Atrial Fibrillation Effect on Quality-of-Life composite (+50.0) were seen at 6 months, sustained at 15 months, and exceeded the minimum clinically important difference. Improvements in Atrial Fibrillation Effect on Quality-of-Life scores were significantly better among participants without documented atrial arrhythmia recurrences. By Canadian Cardiovascular Society Severity of Atrial Fibrillation symptom classification, >80% of patients were asymptomatic (class 0) at 15 months post-ablation compared with only 0.7% at baseline.

Conclusions: Contact force-guided radiofrequency ablation of persistent atrial fibrillation was associated with a significant decrease in antiarrhythmic drug use, cardioversion rate, and hospitalization. Clinically meaningful improvements in quality of life were observed in all patients. The majority of the patients (>80%) were asymptomatic at 15 months post-ablation. The positive clinical impact of improved quality of life and reduced health care utilization may help with shared decision-making in persistent atrial fibrillation treatment. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02817776.
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http://dx.doi.org/10.1161/CIRCEP.120.008867DOI Listing
January 2021

Association Between Quality of Life and Procedural Outcome After Catheter Ablation for Atrial Fibrillation: A Secondary Analysis of a Randomized Clinical Trial.

JAMA Netw Open 2020 12 1;3(12):e2025473. Epub 2020 Dec 1.

Department of Cardiology, Southlake Regional Health Centre, University of Toronto, Newmarket, Ontario, Canada.

Importance: Catheter ablation is effective in reducing atrial fibrillation (AF), but the association of ablation for AF with quality of life is unclear.

Objective: To evaluate whether the procedural outcome of ablation for AF is associated with quality of life (QOL) measures.

Design, Setting, And Participants: This was a prespecified secondary analysis of the Substrate and Trigger Ablation for Reduction of Atrial Fibrillation-Part II (STAR AF II) prospective randomized clinical trial, which compared 3 strategies for ablation of persistent AF. This analysis included 549 of the 589 patients enrolled in the trial who underwent ablation. Enrollment occurred at 35 centers in Europe, Canada, Australia, China, and Korea from November 2010 to July 2012. Data for the current study were analyzed on December 11, 2019.

Interventions: Patients underwent AF ablation with 1 of 3 ablation strategies: (1) pulmonary vein isolation (PVI), (2) PVI plus complex fractionated electrograms, or (3) PVI plus linear lesions.

Main Outcomes And Measures: Quality of life was assessed at baseline and at 6, 12, and 18 months after ablation for AF using the 36-Item Short Form Health Survey and the EuroQol Health-Related Quality of Life 5-Dimension 3-Level questionnaire. Scores were also converted to a physical health component score (PCS) and a mental health component score (MCS). Individual AF burden was calculated by the total time with AF from Holter monitors and the percentage of transtelephonic monitor recordings showing AF.

Results: Among the 549 patients included in this secondary analysis, QOL was assessed in 466 (85%) at baseline and at 6, 12, and 18 months after ablation for AF. The mean (SD) age of the study population was 60 (9) years; 434 (79%) individuals were men, and 417 (76%) had continuous AF for 6 months or more before ablation. The AF burden significantly decreased from a mean (SD) of 82% (36%) before ablation to 6.6% (23%) after ablation (P < .001). Significant improvements in mean (SD) PCS (68.3 [20.7] to 82.5 [18.6]) and MCS (35.3 [8.6] to 37.5 [7.6]) occurred 18 months after ablation (P < .05 for both). Significant QOL improvement occurred in all 3 study arms and regardless of AF recurrence, defined as AF episodes lasting more than 30 seconds: for no recurrence, mean (SD) PCS increased from 66.5 (20.9) to 79.1 (19.4) and MCS from 35.3 (8.7) to 37.7 (7.7); for recurrence, mean (SD) PCS increased from 70.2 (20.4) to 86.4 (16.8) and MCS from 35.3 (8.6) to 37.1 (7.4) (P < .05 for all). When outcome was defined by AF burden reduction, in patients with less than 70% reduction in AF burden, the increase in PCS was significantly less than in those with greater than 70% reduction, and only 3 of 8 subscales showed significant improvement.

Conclusions And Relevance: In this secondary analysis, decreases in AF burden after ablation for AF were significantly associated with improvements in QOL. Quality of life changes were significantly associated with the percentage of AF burden reduction after ablation.

Trial Registration: ClinicalTrials.gov Identifier: NCT01203748.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.25473DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7718606PMC
December 2020

Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation.

N Engl J Med 2021 01 16;384(4):305-315. Epub 2020 Nov 16.

From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.

Background: Guidelines recommend a trial of one or more antiarrhythmic drugs before catheter ablation is considered in patients with atrial fibrillation. However, first-line ablation may be more effective in maintaining sinus rhythm.

Methods: We randomly assigned 303 patients with symptomatic, paroxysmal, untreated atrial fibrillation to undergo catheter ablation with a cryothermy balloon or to receive antiarrhythmic drug therapy for initial rhythm control. All the patients received an implantable cardiac monitoring device to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was the first documented recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) between 91 and 365 days after catheter ablation or the initiation of an antiarrhythmic drug. The secondary end points included freedom from symptomatic arrhythmia, the atrial fibrillation burden, and quality of life.

Results: At 1 year, a recurrence of atrial tachyarrhythmia had occurred in 66 of 154 patients (42.9%) assigned to undergo ablation and in 101 of 149 patients (67.8%) assigned to receive antiarrhythmic drugs (hazard ratio, 0.48; 95% confidence interval [CI], 0.35 to 0.66; P<0.001). Symptomatic atrial tachyarrhythmia had recurred in 11.0% of the patients who underwent ablation and in 26.2% of those who received antiarrhythmic drugs (hazard ratio, 0.39; 95% CI, 0.22 to 0.68). The median percentage of time in atrial fibrillation was 0% (interquartile range, 0 to 0.08) with ablation and 0.13% (interquartile range, 0 to 1.60) with antiarrhythmic drugs. Serious adverse events occurred in 5 patients (3.2%) who underwent ablation and in 6 patients (4.0%) who received antiarrhythmic drugs.

Conclusions: Among patients receiving initial treatment for symptomatic, paroxysmal atrial fibrillation, there was a significantly lower rate of atrial fibrillation recurrence with catheter cryoballoon ablation than with antiarrhythmic drug therapy, as assessed by continuous cardiac rhythm monitoring. (Funded by the Cardiac Arrhythmia Network of Canada and others; EARLY-AF ClinicalTrials.gov number, NCT02825979.).
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http://dx.doi.org/10.1056/NEJMoa2029980DOI Listing
January 2021

The 2020 Canadian Cardiovascular Society/Canadian Heart Rhythm Society Comprehensive Guidelines for the Management of Atrial Fibrillation.

Can J Cardiol 2020 12 22;36(12):1847-1948. Epub 2020 Oct 22.

Institut de Cardiologie de Montréal, Université de Montréal, Montréal, Québec, Canada.

The Canadian Cardiovascular Society (CCS) atrial fibrillation (AF) guidelines program was developed to aid clinicians in the management of these complex patients, as well as to provide direction to policy makers and health care systems regarding related issues. The most recent comprehensive CCS AF guidelines update was published in 2010. Since then, periodic updates were published dealing with rapidly changing areas. However, since 2010 a large number of developments had accumulated in a wide range of areas, motivating the committee to complete a thorough guideline review. The 2020 iteration of the CCS AF guidelines represents a comprehensive renewal that integrates, updates, and replaces the past decade of guidelines, recommendations, and practical tips. It is intended to be used by practicing clinicians across all disciplines who care for patients with AF. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system was used to evaluate recommendation strength and the quality of evidence. Areas of focus include: AF classification and definitions, epidemiology, pathophysiology, clinical evaluation, screening and opportunistic AF detection, detection and management of modifiable risk factors, integrated approach to AF management, stroke prevention, arrhythmia management, sex differences, and AF in special populations. Extensive use is made of tables and figures to synthesize important material and present key concepts. This document should be an important aid for knowledge translation and a tool to help improve clinical management of this important and challenging arrhythmia.
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http://dx.doi.org/10.1016/j.cjca.2020.09.001DOI Listing
December 2020

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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http://dx.doi.org/10.1016/j.cjca.2020.10.013DOI Listing
December 2020

The Canadian Cardiovascular Society Atrial Fibrillation Guidelines Program: A Look Back Over the Last 10 Years and a Look Forward.

Can J Cardiol 2020 12 7;36(12):1839-1842. Epub 2020 Oct 7.

Montréal Heart Institute, University of Montréal, Montréal, Québec, Canada.

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http://dx.doi.org/10.1016/j.cjca.2020.10.001DOI Listing
December 2020

Persistent Atrial Fibrillation Ablation With Contact Force-Sensing Catheter: The Prospective Multicenter PRECEPT Trial.

JACC Clin Electrophysiol 2020 08;6(8):958-969

Texas Cardiac Arrhythmia Research Foundation, Austin, Texas, USA.

Objectives: This study sought to evaluate the safety and effectiveness of catheter ablation of persistent atrial fibrillation (PsAF) using a porous tip contact force-sensing catheter.

Background: Although the safety and effectiveness of catheter ablation of paroxysmal atrial fibrillation are established, there are limited data on outcomes in patients with PsAF. As such, no ablation catheter is currently approved by the Food and Drug Administration for PsAF ablation.

Methods: The prospective, multicenter, nonrandomized PRECEPT (Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH SF Catheter Evaluated for Treating Symptomatic PersistenT AF) study was conducted at 27 sites in the United States and Canada. Enrollment criteria included documented symptomatic PsAF and nonresponse or intolerance to ≥1 antiarrhythmic drug (Class I or III). An individualized treatment approach was used including pulmonary vein isolation with ablation of additional targets permitted at the investigators' discretion. To optimize treatment outcomes, a 3-month post-ablation medication adjustment period followed by a 3-month therapy consolidation period were included. Arrhythmia recurrences were stringently monitored by monthly and symptomatic transtelephonic monitoring, electrocardiography, and Holter monitoring for up to 15 months after ablation.

Results: Of 381 enrolled participants, 348 had the investigational catheter inserted and underwent ablation. The primary adverse event rate was 4.1% (15 events in 14 participants). Kaplan-Meier analyses estimated a primary effectiveness success rate of 61.7% and a clinical success rate of 80.4% at 15 months.

Conclusions: The results demonstrate the clinical safety and effectiveness of PsAF ablation using contact force-sensing technologies. The primary adverse event was within the expected range and similar to those reported in historical studies of paroxysmal AF ablation. (Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH SF Catheter Evaluated for Treating Symptomatic PersistenT AF; NCT02817776).
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http://dx.doi.org/10.1016/j.jacep.2020.04.024DOI Listing
August 2020

Impact of Female Sex on Clinical Presentation and Ablation Outcomes in the CIRCA-DOSE Study.

JACC Clin Electrophysiol 2020 08 29;6(8):945-954. Epub 2020 Jul 29.

Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada. Electronic address:

Objectives: This study sought to evaluate sex-specific differences in atrial fibrillation (AF) presentation and catheter ablation outcomes in the prospective, multicenter, randomized CIRCA-DOSE (Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration) study.

Background: Similar to other cardiovascular conditions, significant sex-specific differences have been observed in the epidemiology, pathophysiology, presentation, and natural history of AF. Unfortunately, there are major gaps in our understanding of the pathophysiological basis for the observed sex-specific differences and their implications on therapy and prognosis.

Methods: This study examined sex-specific differences in AF presentation, symptom severity and health-related quality of life, symptomatic and asymptomatic arrhythmia recurrence, AF burden, and health care utilization.

Results: Freedom from any atrial tachyarrhythmia and symptomatic atrial tachyarrhythmia were similar between male (hazard ratio: 1.18; 95% confidence interval: 0.85 to 1.64; p = 0.39) and female patients (hazard ratio: 1.00; 95% confidence interval: 0.62 to 1.59; p = 0.92). Post-ablation, the median AF burden (percentage time in AF) was 0.00% (interquartile range: 0.00% to 0.16%) in male patients and 0.00% (interquartile range: 0.00% to 0.17%) in female patients, with no difference observed between the sexes (p = 0.30). Periprocedural complications occurred twice as frequently in female patients (3.5% vs. 7.0%; p = 0.18). In comparison to male patients, female patients reported a significantly worse symptom score and quality of life at baseline and all follow-up intervals, but they derived similar magnitude of improvement post-ablation. There was no difference between male and female patients with respect to emergency department visits, hospitalization, cardioversion, or repeat ablation.

Conclusions: When compared with male patients, female patients have significantly worse symptom scores and quality of life at baseline. Despite this, female patients with symptomatic paroxysmal AF derive similar benefit in freedom from recurrent arrhythmia and similar improvements in quality of life following AF ablation. (Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration [CIRCA-DOSE]; NCT01913522).
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http://dx.doi.org/10.1016/j.jacep.2020.04.032DOI Listing
August 2020

Quality of Life and Health Care Utilization in the CIRCA-DOSE Study.

JACC Clin Electrophysiol 2020 08;6(8):935-944

Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada; Montreal Health Innovations Coordinating Centre, Montreal, Québec, Canada.

Objectives: This study evaluated the impact of contact force-guided radiofrequency ablation versus cryoballoon ablation on quality of life and health care utilization.

Background: Traditional outcome parameters, such as arrhythmia-free survival, are insufficient to evaluate the clinical impact of atrial fibrillation (AF), as it fails to the capture patient- and health system-level differences in treatment approaches.

Methods: The CIRCA-DOSE (Cryoballoon Vs. Contact-Force Atrial Fibrillation Ablation) study randomly assigned 346 patients with drug-refractory paroxysmal AF to contact force-guided radiofrequency or cryoballoon ablation. Health-related quality-of-life (HRQOL) was assessed at baseline, and at 6 and 12 months post-ablation using a disease-specific and generic HRQOL instruments. Health care utilization (hospitalization, emergency department visits, and cardioversion) and antiarrhythmic drug use for the 12 months preceding ablation was compared with the 12 months following ablation.

Results: Disease-specific and generic HRQOL was moderately to severely impaired at baseline and improved significantly at 6 and 12 months of follow-up (median improvement in AFEQT [Atrial Fibrillation Effect on QualiTy of Life] score 32.4 [interquartile range: 17.7 to 48.9]). When compared with the 12 months pre-ablation, the proportion and absolute number of cardioversions decreased significantly (41.1% vs. 10.1% of patients, 137 vs. 35 events; p < 0.0001). Similar significant reductions in emergency department visits (66.7% vs. 25.1% of patients, 224 vs. 87 events; p < 0.0001), and hospitalizations (25.5% vs. 14.5% of patients, 86 vs. 50 events; p < 0.001) were observed. There were no significant differences between randomized groups.

Conclusions: In this multicenter randomized trial, catheter ablation with advanced-generation technologies resulted in a significant improvement in HRQOL and a significant reduction in health care utilization in the year following AF ablation. (Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation [CIRCA-DOSE]; NCT01913522).
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http://dx.doi.org/10.1016/j.jacep.2020.04.017DOI Listing
August 2020

Repeat Atrial Fibrillation Ablation Procedures in the CIRCA-DOSE Study.

Circ Arrhythm Electrophysiol 2020 09 23;13(9):e008480. Epub 2020 Jul 23.

Department of Medicine, University of British Columbia, Vancouver, Canada (C.C.C., M.W.D., J.G.A.).

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http://dx.doi.org/10.1161/CIRCEP.120.008480DOI Listing
September 2020

The Cryoballoon vs Irrigated Radiofrequency Catheter Ablation (CIRCA-DOSE) Study Results in Context.

Arrhythm Electrophysiol Rev 2020 Jun;9(1):34-39

Montreal Heart Institute, Department of Medicine, University of Montreal, Montreal, Canada.

The Cryoballoon vs Irrigated Radiofrequency Catheter Ablation: Double Short vs Standard Exposure Duration (CIRCA-DOSE) study was a multicentre, randomised, single-blinded trial that compared contact-force radiofrequency ablation and two different regimens of cryoballoon ablation. All patients received an implantable cardiac monitor for the purpose of continuous rhythm monitoring, with all arrhythmia events undergoing independent adjudication by a committee blinded to treatment allocation. The study demonstrated there were no significant differences between contact-force radiofrequency ablation and cryoballoon ablation with respect to recurrence of any atrial tachyarrhythmia, symptomatic atrial tachyarrhythmia, asymptomatic AF, symptomatic AF or AF burden. While the results of the CIRCA-DOSE study are reviewed here, this article focuses on considerations around the design of the study and places the observed outcomes in context.
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http://dx.doi.org/10.15420/aer.2019.13DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7330729PMC
June 2020

Impact of Left Common Pulmonary Veins in the Contact-Force vs. Cryoballoon Atrial Fibrillation Ablation (CIRCA-DOSE) Study.

J Cardiovasc Electrophysiol 2020 Jul 6. Epub 2020 Jul 6.

Heart Rhythm Services, Department of Medicine, University of British Columbia, Canada.

Background: Concerns remain regarding the effectiveness of PVI using the fixed diameter non-compliant cryoballoon in the presence of a left common pulmonary vein (LCPV). We sought to evaluate the effectiveness of PVI performed by contact-force guided radiofrequency (CF-RF) versus second-generation cryoballoon-based ablation in patients with LCPV.

Methods And Results: We enrolled 346 patients with paroxysmal AF and randomized them to CF-RF or cryoballoon ablation. PV anatomy was not assessed prior to enrolment, and there were no exclusions based on PV anatomy. All patients received an implantable cardiac monitor. LCPV was observed in 13.6% of patients (47/346). Left atrial time and fluoroscopy time did not differ between those with and without LCPV (P=0.58 and P=0.06, respectively). Freedom from any atrial tachyarrhythmia at one year was observed in 46.8% with LCPV and 54.5% without LCPV (P=0.06). In those with LCPV the freedom from any atrial tachyarrhythmia did not differ between those randomized to CF-RF or cryoballoon ablation (HR for recurrence 1.19, 95% CI 0.53-2.65, P=0.69). In those with LCPV the AF burden was reduced to a similar extent with CF-RF and cryoballoon ablation (99.7% vs. 99.5%, respectively; P=0.97).

Conclusions: In this randomized clinical trial, the presence of a LCPV was associated with a trend towards higher rates of arrhythmia recurrence following PVI. No significant difference in arrhythmia recurrence was observed between patients with LCPV randomized to cryoballoon ablation or contact-force guided RF ablation, suggesting that either ablation modality is suitable in this population. (Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation [CIRCA-DOSE], NCT01913522) This article is protected by copyright. All rights reserved.
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http://dx.doi.org/10.1111/jce.14652DOI Listing
July 2020

Association of Atrial Fibrillation Episode Duration With Arrhythmia Recurrence Following Ablation: A Secondary Analysis of a Randomized Clinical Trial.

JAMA Netw Open 2020 07 1;3(7):e208748. Epub 2020 Jul 1.

Montreal Heart Institute, Department of Medicine, Université de Montréal, Montréal, Quebec, Canada.

Importance: Contemporary guidelines recommend that atrial fibrillation (AF) be classified based on episode duration, with these categories forming the basis of therapeutic recommendations. While pragmatic, these classifications are not based on pathophysiologic processes and may not reflect clinical outcomes.

Objective: To evaluate the association of baseline AF episode duration with post-AF ablation arrhythmia outcomes.

Design, Setting, And Participants: The current study is a secondary analysis of a prospective, parallel-group, multicenter, single-masked randomized clinical trial (the Cryoballoon vs Irrigated Radiofrequency Catheter Ablation: Double Short vs Standard Exposure Duration [CIRCA-DOSE] study), which took place at 8 Canadian centers. Between September 2014 and July 2017, 346 patients older than 18 years with symptomatic AF referred for first catheter ablation were enrolled. All patients received an implantable cardiac monitor at least 30 days before ablation. Data analysis was performed in September 2019.

Exposure: Before ablation, patients were classified based on their longest AF episode. Ablation consisted of circumferential pulmonary vein isolation using standard techniques.

Main Outcomes And Measures: Time to first recurrence of symptomatic or asymptomatic atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia) following ablation and AF burden (percentage of time in AF) on preablation and postablation continuous rhythm monitoring.

Results: The study included 346 patients (mean [SD] age, 59 [10] years; 231 [67.7%] men). Overall, 263 patients (76.0%) had AF episode duration of less than 24 hours; 25 (7.2%), 24 to 48 hours; 40 (11.7%), 2 to 7 days; and 18 (5.2%), more than 7 days. Documented recurrence of any atrial tachyarrhythmia following ablation was significantly lower in patients with baseline AF episode duration of less than 24 continuous hours compared with those with longer AF episodes (24 hours vs 24-48 hours: hazard ratio [HR], 0.41; 95% CI, 0.21-0.80; P = .009; 24 hours vs 2-7 days: HR, 0.25; 95% CI, 0.14-0.45; P < .001; 24 hours vs >7 days: HR, 0.23; 95% CI, 0.09-0.55; P < .001). Patients with preablation AF episodes limited to less than 24 continuous hours had a significantly lower median (interquartile range) postablation AF burden (0% [0%-0.1%]) compared with those with AF preablation episodes lasting 2-7 days (0.1% [0%-1.0%]; P = .003) and those with AF preablation episodes lasting more than 7 days (1.0% [0%-5.4%]; P = .008). There was no significant difference in arrhythmia recurrence or AF burden between the 3 groups with a baseline AF episode duration of longer than 24 hours.

Conclusions And Relevance: In this study, patients with AF episodes limited to less than 24 continuous hours had a significantly lower incidence of arrhythmia recurrence following AF ablation. This suggests that current guidelines for classification of AF may not reflect clinical outcomes.

Trial Registration: ClinicalTrials.gov Identifier: NCT01913522.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.8748DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7333024PMC
July 2020

Efficacy and Safety of Same-Day Discharge for Atrial Fibrillation Ablation.

JACC Clin Electrophysiol 2020 06 29;6(6):609-619. Epub 2020 Apr 29.

Heart Rhythm Services, Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada.

Objectives: The purpose of this study was to evaluate the efficacy, health care utilization, and safety of a same-day discharge protocol.

Background: Catheter ablation of atrial fibrillation (AF) is the most common ablation performed. Increasing volumes of AF ablation are placing demands on hospital resources. In response, our institutions developed a same-day discharge protocol for AF ablation.

Methods: This was a multicenter cohort study of all patients undergoing AF ablation from 2010 to 2014 at 2 major centers. The primary efficacy outcome was the proportion of successful same-day discharges. The primary health care utilization outcome was 30-day hospital readmission for any reason. The primary safety outcome was a composite of 30-day death, stroke/transient ischemic attack or embolism, or bleeding requiring hospitalization.

Results: A total of 3,054 patients underwent AF ablation from 2010 to 2014 and met inclusion criteria. Same-day discharge was achieved in 79.2% (2,418 of 3,054). Hospital readmission at 30 days was 7.7% for the same-day discharge group, 10.2% for those who remained in the hospital overnight without complications (p = 0.055 for comparison with same-day discharge), and 19.5% (p < 0.001) for those who remained in the hospital with procedural complications (7.7%). Complication rates from discharge to 30 days (excluding immediate procedural complications) were 0.37% for the same-day discharge group, 0.36% (p = 0.999) for those kept overnight without complications, and 2.5% (p = 0.044) for those with initial procedural complications.

Conclusions: Same-day discharge after AF ablation is feasible in the majority of patients with use of a standardized protocol. This approach was not associated with higher hospital readmission or complication rates after discharge.
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http://dx.doi.org/10.1016/j.jacep.2020.02.009DOI Listing
June 2020

Addressing Extracardiac Risk Factors to Improve Atrial Fibrillation Treatment Outcomes.

J Innov Card Rhythm Manag 2019 Nov 15;10(11):3881-3890. Epub 2019 Nov 15.

Institut de Cardiologie de Montreal, Montréal, QC, Canada.

Atrial fibrillation (AF) is a chronic progressive disease. The contemporary management of AF is centered on promoting a reduction in the rates of morbidity and mortality associated with the condition. While stroke prevention and rate/rhythm management remain the cornerstones of AF care, recently, there has been increasing interest arising in addressing modifiable cardiovascular risk factors. Emerging data suggest that the optimization of these could beneficially affect AF pathogenesis and associated outcomes. The purpose of this review was to examine common modifiable risk factors with a look to pragmatic intervention.
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http://dx.doi.org/10.19102/icrm.2019.101103DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7252720PMC
November 2019

Infections Associated with Resterilized Pacemakers and Defibrillators.

N Engl J Med 2020 05;382(19):1823-1831

From the Montreal Heart Institute, Université de Montréal, Montreal (T.F.K., M.-A.L., C.V., R.C., D.R., M.T., M.D., B.T., P.G.G., L.R., K.D., B.M., R.T., J.C.-T., L.M., P.K.); Instituto Nacional de Cardiologia, Ignacio Chavez, Mexico City (S.N.); the Dominican Institute of Cardiology, Santo Domingo, Dominican Republic (F.V.B.); Clínicas Médicas las Américas, Guatemala City, Guatemala (F.S.O.); and Cardiología Hospital General del Sur, Choluteca (N.E.L.O.), and Instituto Nacional Cardiopulmonar (G.S.M.) and Medicina Interna-Programación de Marcapaso Definitivo, Instituto Nacional Cardiopulmonar, Tegucigalpa (C.A.C.) - all in Honduras.

Background: Access to pacemakers and defibrillators is problematic in places with limited resources. Resterilization and reuse of implantable cardiac devices obtained post mortem from patients in wealthier nations have been undertaken, but uncertainty around the risk of infection is a concern.

Methods: A multinational program was initiated in 1983 to provide tested and resterilized pacemakers and defibrillators to underserved nations; a prospective registry was established in 2003. Patients who received reused devices in this program were matched in a 1:3 ratio with control patients who received new devices implanted in Canada. The primary outcome was infection or device-related death, with mortality from other causes modeled as a competing risk.

Results: Resterilized devices were implanted in 1051 patients (mean [±SD] age, 63.2±18.5 years; 43.6% women) in Mexico (36.0%), the Dominican Republic (28.1%), Guatemala (26.6%), and Honduras (9.3%). Overall, 85% received pacemakers and 15% received defibrillators, with one (55.5%), two (38.8%), or three (5.7%) leads. Baseline characteristics did not differ between these patients and the 3153 matched control patients. At 2 years of follow-up, infections had occurred in 21 patients (2.0%) with reused devices and in 38 (1.2%) with new devices (hazard ratio, 1.66; 95% confidence interval, 0.97 to 2.83; P = 0.06); there were no device-related deaths. The most common implicated pathogens were and .

Conclusions: Among patients in underserved countries who received a resterilized and reused pacemaker or defibrillator, the incidence of infection or device-related death at 2 years was 2.0%, an incidence that did not differ significantly from that seen among matched control patients with new devices in Canada.
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http://dx.doi.org/10.1056/NEJMoa1813876DOI Listing
May 2020

Clinical assessment of AF pattern is poorly correlated with AF burden and post ablation outcomes: A CIRCA-DOSE sub-study.

J Electrocardiol 2020 May - Jun;60:159-164. Epub 2020 Mar 21.

Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada.

Background: Contemporary guidelines recommend that atrial fibrillation (AF) be classified into paroxysmal and persistent AF based on clinical assessment, with these categorizations forming the basis of therapeutic recommendations. While pragmatic, clinical assessment may introduce misclassification errors, which may impact treatment decisions. We sought to determine the relationship between AF classification, baseline AF burden, and post-ablation arrhythmia outcomes.

Design: The current study is a sub-analysis of a prospective, parallel-group, multicenter, single-blinded randomized clinical trial. All 346 patients enrolled in CIRCA-DOSE received an implantable cardiac monitor a median of 72 days prior to ablation. AF was classified as low burden paroxysmal, high burden paroxysmal, or persistent based on clinical assessment prior to device implantation. Prior to ablation patients were re-classified using the same definitions based on device monitoring data. Correlation between classifications, AF burden, and post-ablation arrhythmia outcomes were assessed.

Results: There was poor agreement between clinical and device-based AF classification (Cohen's kappa: 0.192). AF classification derived from pre-ablation continuous monitoring reflected baseline and post-ablation AF burden with greater accuracy and with less overlap between the AF classes (P < 0.01 for all categorical comparisons). Patients objectively classified as "Low Burden" paroxysmal by continuous monitoring data had significantly greater freedom from recurrent AF/AT/AFL compared to those classified as "High Burden" paroxysmal (hazard ratio [HR] 0.57 for AF/AT/AFL recurrence) or persistent AF (HR 0.19 for AF/AT/AFL recurrence).

Conclusions: Classification of AF pattern based on pre-ablation continuous cardiac rhythm monitoring better predicted AF burden and freedom from recurrent AF post ablation. Despite the use of standardized definitions, classification of AF based on clinical assessment did not predict baseline AF burden, post ablation AF burden, or freedom from recurrent AF post ablation.

Trial Registration: ClinicalTrials.govNCT01913522.
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http://dx.doi.org/10.1016/j.jelectrocard.2020.03.008DOI Listing
March 2020

Effectiveness and safety of atrial fibrillation ablation in females.

Pacing Clin Electrophysiol 2020 06 25;43(6):583-592. Epub 2020 May 25.

Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.

Background: Existing data on the effectiveness and safety of atrial fibrillation (AF) ablation in females are limited to studies of small sample size, lacking longer term follow-up or adjustment for potential confounders.

Methods: A total of 6421 patients (2072 females) undergoing a first AF ablation procedure after enrollment in the Chinese Atrial Fibrillation Registry (China-AF) study between August 2011 and December 2017 were analyzed. We evaluated the effectiveness (recurrence of documented [symptomatic or not] atrial tachyarrhythmia (AT)) and the safety (incidence of procedure-related complications) of AF ablation in female patients compared to male patients. Sensitivity analyses based on routine data were also utilized to avoid potential sex differences in reporting of AF symptoms.

Results: Females were about 5 years older than males at the time of ablation (mean age 63.4 ± 9.5 vs 58.3 ± 10.8, P < .0001). A higher proportion of female patients had paroxysmal AF (74.3% vs 56.7%, P < .0001), hypertension (69.7% vs 61.3%, P < .0001), and hyperlipidemia (57.2% vs 52.9%, P = .001). Female sex was found to be an independent risk factor of AT recurrence in multivariate analyses (HR = 1.26, 95% CI 1.15-1.38, P < .0001). These findings were confirmed in sensitivity analyses using only Holter data. Female sex was also associated with a higher risk of periprocedural complications after adjustment for baseline variables (OR = 1.41, 95% CI 1.03-1.94, P = .03).

Conclusions: Female sex is an independent risk factor of AT recurrence and periprocedural complications after AF ablation.
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http://dx.doi.org/10.1111/pace.13921DOI Listing
June 2020

Electrical versus pharmacological cardioversion for emergency department patients with acute atrial fibrillation (RAFF2): a partial factorial randomised trial.

Lancet 2020 02;395(10221):339-349

Department of Emergency Medicine, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.

Background: Acute atrial fibrillation is the most common arrythmia treated in the emergency department. Our primary aim was to compare conversion to sinus rhythm between pharmacological cardioversion followed by electrical cardioversion (drug-shock), and electrical cardioversion alone (shock-only). Our secondary aim was to compare the effectiveness of two pad positions for electrical cardioversion.

Methods: We did a partial factorial trial of two protocols for patients with acute atrial fibrillation at 11 academic hospital emergency departments in Canada. We enrolled adult patients with acute atrial fibrillation. Protocol 1 was a randomised, blinded, placebo-controlled comparison of attempted pharmacological cardioversion with intravenous procainamide (15 mg/kg over 30 min) followed by electrical cardioversion if necessary (up to three shocks, each of ≥200 J), and placebo infusion followed by electrical cardioversion. For patients having electrical cardioversion, we used Protocol 2, a randomised, open-label, nested comparison of anteroposterior versus anterolateral pad positions. Patients were randomly assigned (1:1, stratified by study site) for Protocol 1 by on-site research personnel using an online electronic data capture system. Randomisation for Protocol 2 occurred 30 min after drug infusion for patients who had not converted and was stratified by site and Protocol 1 allocation. Patients and all research and emergency department staff were masked to treatment allocation for Protocol 1. The primary outcome was conversion to normal sinus rhythm for at least 30 min at any time after randomisation and up to a point immediately after three shocks. Protocol 1 was analysed by intention to treat and Protocol 2 excluded patients who did not receive electrical cardioversion. This study is registered at ClinicalTrials.gov, number NCT01891058.

Findings: Between July 18, 2013, and Oct 17, 2018, we enrolled 396 patients, and none were lost to follow-up. In the drug-shock group (n=204), conversion to sinus rhythm occurred in 196 (96%) patients and in the shock-only group (n=192), conversion occurred in 176 (92%) patients (absolute difference 4%; 95% CI 0-9; p=0·07). The proportion of patients discharged home was 97% (n=198) versus 95% (n=183; p=0·60). 106 (52%) patients in the drug-shock group converted after drug infusion only. No patients had serious adverse events in follow-up. The different pad positions in Protocol 2 (n=244), had similar conversions to sinus rhythm (119 [94%] of 127 in anterolateral group vs 108 [92%] of 117 in anteroposterior group; p=0·68).

Interpretation: Both the drug-shock and shock-only strategies were highly effective, rapid, and safe in restoring sinus rhythm for patients in the emergency department with acute atrial fibrillation, avoiding the need for return to hospital. The drug infusion worked for about half of patients and avoided the resource intensive procedural sedation required for electrical cardioversion. We also found no significant difference between the anterolateral and anteroposterior pad positions for electrical cardioversion. Immediate rhythm control for patients in the emergency department with acute atrial fibrillation leads to excellent outcomes.

Funding: Heart and Stroke Foundation of Canada and the Canadian Institutes of Health Research.
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http://dx.doi.org/10.1016/S0140-6736(19)32994-0DOI Listing
February 2020

Prevalence and clinical impact of spontaneous and adenosine-induced pulmonary vein reconduction in the Contact-Force vs. Cryoballoon Atrial Fibrillation Ablation (CIRCA-DOSE) study.

Heart Rhythm 2020 06 21;17(6):897-904. Epub 2020 Jan 21.

Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Canada.

Background: Use of intraprocedural observation and pharmacologic challenges have been proposed as means to differentiate permanent pulmonary vein (PV)-left atrial conduction block from inadequate ablation lesions.

Objective: The purpose of this study was to determine the prevalence and clinical impact of spontaneous and adenosine-provoked reconnection using contemporary atrial fibrillation (AF) ablation technologies.

Methods: The CIRCA-DOSE (Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration) study enrolled 346 patients with paroxysmal AF and randomized them to contact force-guided radiofrequency ablation (CF-RF) or cryoballoon ablation. Patients underwent provocative testing with adenosine after a 20-minute observation period. All patients received an implantable cardiac monitor for arrhythmia monitoring.

Results: Spontaneous reconnection was observed in 5.4% of PVs (71/1318) during the 20-minute postprocedure observation period, and dormant conduction was elicited in 5.7% of PVs (75/1318). Both spontaneous reconnection and dormant conduction were more common after CF-RF compared to cryoballoon ablation (P = .03 and P <.0001, respectively). Acute PV reconnection (spontaneous or adenosine-provoked) was associated with a significantly higher incidence of recurrent atrial tachyarrhythmia in the cryoballoon group (hazard ratio [HR] 2.39; 95% confidence interval [CI] 1.44-3.96; P = .0007) but not in the CF-RF group (HR 1.47; 95% CI 0.84-2.58; P = .16). In the absence of acute reconnection, the freedom from recurrent arrhythmia did not differ between groups (HR 0.95; 95% CI 0.6057-1.495; P = .83).

Conclusion: Patients without spontaneous or adenosine-provoked reconnection had better outcomes compared to those with acute PV reconnection, suggesting that efforts should be directed toward ensuring an ideal ablation lesion at the first attempt in order to achieve durable PV isolation.
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http://dx.doi.org/10.1016/j.hrthm.2020.01.017DOI Listing
June 2020

Non-Vitamin K Antagonist Oral Anticoagulants in Adult Congenital Heart Disease.

Can J Cardiol 2019 Dec 26;35(12):1686-1697. Epub 2019 Jun 26.

Adult Congenital Heart Center, Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada; Division of electrophysiology, Department of medicine, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.

Non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) have several advantages over VKAs that render them an attractive option for adults with congenital heart disease (CHD). Efficacy and safety data specific to the adult CHD population are emerging. Herein, we synthesize the growing literature regarding NOACs in adults with CHD and attempt to identify subgroups for which it appears reasonable to extrapolate data from populations without CHD. Small observational studies suggest that NOACs are safe and effective in selected adults with CHD. NOACs are contraindicated in patients with a mechanical valve, in those with mitral or tricuspid valve stenosis with enlarged and diseased atria, with or without a mitral or tricuspid bioprosthesis, and after recent cardiac surgery (< 3 months). There is currently insufficient evidence to recommend NOACs in patients with a Fontan circulation or cyanotic CHD. Growing literature supports the use of NOACs in patients without CHD who have various forms of valvular heart disease. Therefore, when an indication for oral anticoagulation is established, it appears reasonable to consider a NOAC instead of a VKA in adults with CHD lesions analogous to isolated mitral regurgitation, tricuspid regurgitation, or aortic regurgitation or stenosis. The NOAC agent selected and the prescribed dose should be tailored according to bleeding risk, body weight, renal function, and comedications, especially antiepileptic drugs. The decision to initiate a NOAC should be shared between the patient and care provider. Large-scale research studies are required to further assess safety and efficacy in selected patient subgroups.
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http://dx.doi.org/10.1016/j.cjca.2019.06.022DOI Listing
December 2019

Cryoballoon or Radiofrequency Ablation for Atrial Fibrillation Assessed by Continuous Monitoring: A Randomized Clinical Trial.

Circulation 2019 11 21;140(22):1779-1788. Epub 2019 Oct 21.

Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Canada (J.G.A., M.D., L.M., P.K.).

Background: Advanced generation ablation technologies have been developed to achieve more effective pulmonary vein isolation (PVI) and minimize arrhythmia recurrence after atrial fibrillation (AF) ablation.

Methods: We randomly assigned 346 patients with drug-refractory paroxysmal AF to contact force-guided radiofrequency ablation (CF-RF; n=115), 4-minute cryoballoon ablation (Cryo-4; n=115), or 2-minute cryoballoon ablation (Cryo-2; n=116). Follow-up was 12 months. The primary outcome was time to first documented recurrence of symptomatic or asymptomatic atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia) between days 91 and 365 after ablation or a repeat ablation procedure at any time. Secondary end points included freedom from symptomatic arrhythmia and AF burden. All patients received an implantable loop recorder.

Results: One-year freedom from atrial tachyarrhythmia defined by continuous rhythm monitoring was 53.9%, 52.2%, and 51.7% with CF-RF, Cryo-4, and Cryo-2, respectively (=0.87). One-year freedom from symptomatic atrial tachyarrhythmia defined by continuous rhythm monitoring was 79.1%, 78.2%, and 73.3% with CF-RF, Cryo-4, and Cryo-2, respectively (=0.26). Compared with the monitoring period before ablation, AF burden was reduced by a median of 99.3% (interquartile range, 67.8%-100.0%) with CF-RF, 99.9% (interquartile range, 65.3%-100.0%) with Cryo-4, and 98.4% (interquartile range, 56.2%-100.0%) with Cryo-2 (=0.36). Serious adverse events occurred in 3 patients (2.6%) in the CF-RF group, 6 patients (5.3%) in the Cryo-4 group, and 7 patients (6.0%) in the Cryo-2 group, with no significant difference between groups (=0.24). The CF-RF group had a significantly longer procedure duration but significantly shorter fluoroscopy exposure (<0.001 vs cryoballoon groups).

Conclusions: In this multicenter, randomized, single-blinded trial, CF-RF and 2 different regimens of cryoballoon ablation resulted in no difference in 1-year efficacy, which was 53% by time to first recurrence but >98% burden reduction as assessed by continuous cardiac rhythm monitoring.

Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01913522.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.119.042622DOI Listing
November 2019