Publications by authors named "Bernard Thibault"

147 Publications

Canadian Registry of Electronic Device Outcomes: remote monitoring outcomes in the Abbott battery performance alert-a multicentre cohort.

Europace 2021 Feb 20. Epub 2021 Feb 20.

Department of Medicine, Division of Cardiology, QEII Health Sciences Center, Halifax Infirmary Site, 796 Summer Street, Room 2501D, Halifax NS B3H 3A7, Canada.

Aims: Cardiac implantable electronic devices with device advisories have the potential of device malfunction. Remote monitoring (RM) of devices has been suggested to allow the identification of abnormal device performance and permit early intervention. We sought to describe the outcomes of patients with and without RM in devices subject to the Abbott Premature Battery Depletion (PBD) advisory with data from a Canadian registry.

Methods And Results: Patients with an Abbott device subject to the PBD advisory from nine implantable cardioverter defibrillator (ICD) implanting centres in Canada were included in the registry. The use of RM was identified from baseline and follow-up data in the registry. The primary outcome was detection of PBD and all-cause mortality. A total of 2666 patients were identified with a device subject to the advisory. In all, 1687 patients (63.2%) had RM at baseline. There were 487 deaths during follow-up. At a mean follow-up of 5.7 ± 0.7 years, mortality was higher in those without a remote monitor compared with RM at baseline (24.7% vs. 14.5%; P < 0.001). Pre-mature battery depletion was identified in 36 patients (2.1%) with RM vs. 7 (0.7%) without RM (P = 0.004). Time to battery replacement was significantly reduced in patients on RM (median 5 vs. 13 days, P = 0.001).

Conclusion: The use of RM in patients with ICD and cardiac resynchronization therapy under advisory improved detection of PBD, time to device replacement, and was associated with a reduction in all-cause mortality. The factors influencing the association with mortality are unknown and deserve further study.
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http://dx.doi.org/10.1093/europace/euab025DOI Listing
February 2021

Canadian Registry of Electronic Device Outcomes (CREDO): The Abbott ICD Premature Battery Depletion Advisory, a Multicentre Cohort Study.

CJC Open 2021 Jan 12;3(1):48-53. Epub 2020 Sep 12.

Department of Medicine, Division of Cardiology, QEII Health Sciences Center, Halifax, Nova Scotia, Canada.

Background: Premature or rapid battery depletion may compromise the performance and reliability of an implantable cardioverter defibrillator (ICD), potentially resulting in harm or death to patients. We sought to describe the outcomes and clinical management of devices included in the Abbott ICD Premature Battery Depletion Advisory, using data from a Canadian registry.

Methods: This prospective observational study includes patients with an Abbott device subject to the advisory, from 9 centres in Canada. The incidence and outcomes related to device revision owing to premature battery depletion were identified and adjudicated by a committee.

Results: There were 2678 patients enrolled with a device subject to the advisory. Devices were implanted between 2010 and 2017; follow-up time was 5.7 ± 0.7 years. Device revision occurred in 222 patients (8.3%). Revision for premature battery depletion occurred in 43 patients (1.6%). Devices were revised at physician discretion on notice of the advisory in 16 patients (0.6%), and at patient request in 5 patients (0.2%). A total of 63 (2.4%) devices reached routine end of battery life. A further 95 (3.5%) patients underwent revision for other reasons. There were no reported major complications or adverse events with device revision owing to the advisory. There were no deaths attributed to premature battery depletion.

Conclusions: The rate of premature battery depletion associated with the Abbott ICD Premature Battery Depletion Advisory is low. There were no clinically adverse events identified that were associated with the battery performance of devices under advisory.
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http://dx.doi.org/10.1016/j.cjco.2020.09.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7801196PMC
January 2021

Post-operative pain following cardiac implantable electronic device implantation: insights from the BRUISE CONTROL trials.

Europace 2020 Dec 28. Epub 2020 Dec 28.

Division of Cardiology, Department of Medicine, University of Calgary, Libin Cardiovascular Institute, Calgary, AB, Canada.

Aims : Post-operative pain following cardiac implantable electronic device (CIED) insertion is associated with patient dissatisfaction, emotional distress, and emergency department visits. We sought to identify factors associated with post-operative pain and develop a prediction score for post-operative pain.

Methods And Results : All patients from the BRUISE CONTROL-1 and 2 trials were included in this analysis. A validated Visual Analogue Scale (VAS) was used to assess the severity of pain related to CIED implant procedures. Patients were asked to grade the most severe post-operative pain, average post-operative pain, and pain on the day of the first post-operative clinic. Multivariable regression analyses were performed to identify predictors of significant post-operative pain and to develop a pain-prediction score. A total of 1308 patients were included. Multivariable regression analysis found that the presence of post-operative clinically significant haematoma {CSH; P value < 0.001; odds ratio (OR) 3.82 [95% confidence interval (CI): 2.37-6.16]}, de novo CIED implantation [P value < 0.001; OR 1.90 (95% CI: 1.47-2.46)], female sex [P value < 0.001; OR 1.61 (95% CI: 1.22-2.12)], younger age [<65 years; P value < 0.001; OR 1.54 (95% CI: 1.14-2.10)], and lower body mass index [<20 kg/m2; P value < 0.05; OR 2.05 (95% CI: 0.98-4.28)] demonstrated strong and independent associations with increased post-operative pain. An 11-point post-operative pain prediction score was developed using the data.

Conclusion : Our study has identified multiple predictors of post-operative pain after CIED insertion. We have developed a prediction score for post-operative pain that can be used to identify individuals at risk of experiencing significant post-operative pain.
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http://dx.doi.org/10.1093/europace/euaa349DOI Listing
December 2020

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

Can J Cardiol 2020 Dec 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

Electrical synchronization achieved by multipoint pacing combined with dynamic atrioventricular delay.

J Interv Card Electrophysiol 2020 Aug 1. Epub 2020 Aug 1.

Cleveland Clinic, Cleveland, OH, USA.

Purpose: Multipoint pacing (MPP) improves left ventricular (LV) electrical synchrony in cardiac resynchronization therapy (CRT). SyncAV automatically adjusts atrioventricular delay (AVD) according to intrinsic AV intervals and may further improve synchrony. Their combination has not been assessed. The objective was to evaluate the improvement in electrical synchrony achieved by SyncAV combined with MPP in an international, multicenter study.

Methods: Patients with LBBB undergoing CRT implant with a quadripolar lead (Abbott Quartet™) were prospectively enrolled. QRS duration (QRSd) was measured by blinded observers from 12-lead ECG during: intrinsic conduction, BiV pacing (conventional biventricular pacing, nominal static AVD), MPP (2 LV cathodes maximally spaced, nominal static AVD), BiV + SyncAV, and MPP + SyncAV. All SyncAV offsets were individualized for each patient to yield the narrowest QRSd during BiV pacing. QRSd changes were compared by ANOVA and post hoc Tukey-Kramer tests.

Results: One hundred and three patients were enrolled (65.7 ± 12.1 years, 67% male, 37% ischemic, EF 26.4 ± 6.5%, PR 190.3 ± 39.1 ms). Relative to intrinsic conduction (QRSd of 165 ± 16 ms), BiV reduced QRSd by 11.9% to 145 ± 18 ms (P < 0.001 vs intrinsic), and MPP reduced QRSd by 13.3% to 142 ± 19 ms (P < 0.001 vs intrinsic). However, enabling SyncAV with a patient-optimized offset nearly doubled this QRSd reduction. BiV + SyncAV reduced QRSd by 22.0% to 128 ± 13 ms (P < 0.001 vs BiV), while MPP + SyncAV reduced QRSd further by 25.6% to 122 ± 14 ms (P < 0.05 vs BiV + SyncAV).

Conclusion: SyncAV can significantly improve acute electrical synchrony beyond conventional CRT, with further improvement achieved by superimposing MPP.
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http://dx.doi.org/10.1007/s10840-020-00842-7DOI Listing
August 2020

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

Mortality Risk Increases With Clustered Ventricular Arrhythmias in Patients With Implantable Cardioverter-Defibrillators.

JACC Clin Electrophysiol 2020 03 29;6(3):327-337. Epub 2020 Jan 29.

Division of Cardiology, Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada.

Objectives: This study sought to examine the adverse prognosis associated with ventricular arrhythmia clusters that falls outside the current electrical storm definition.

Background: Electrical storm is most frequently defined as a cluster of ≥3 episodes of ventricular arrhythmia (VA) in a 24-h period. This definition has been associated with adverse cardiovascular outcomes and mortality, but the effect of lesser and greater clustering of arrhythmias has not been described.

Methods: Among all patients in the Resynchronization in Ambulatory Heart Failure trial, 14,515 implantable cardioverter-defibrillator-detected events with data available were rigorously adjudicated in blinded fashion. Arrhythmia incidence was examined for clustering, defined as 2 or more VA events occurring within 3 months. The prognostic importance of clustering was analyzed by varying the cluster length and number of events used to define a cluster. Mortality rates of groups with clustered arrhythmias were compared to patients with no arrhythmia or with unclustered arrhythmia.

Results: The trial included 1,764 patients, among whom 465 patients had two or more VA episodes within 3 months, whereas 406 had unclustered arrhythmias. Compared to patients with no arrhythmia, patients experiencing unclustered VA had increased risk of death (hazard ratio [HR]: 1.45; 95% confidence interval [CI]: 1.09 to 1.93; p = 0.011), whereas the risk was even higher in patients with clustered arrhythmia (HR: 2.68; 95% CI: 2.13 to 3.36; p < 0.0001). Mortality risk increased with higher VA burden (number of VAs in a cluster) and shorter cluster length. This was observed in all groups tested, including the cluster with the least VA burden in the longest cluster length tested (2 VA episodes occurring within 3 months) (mortality HR: 2.85; 95% CI: 1.95 to 4.17; p < 0.0001). Although clustered arrhythmias terminated with antitachycardia pacing were associated with increased mortality, clusters terminated with implantable cardioverter-defibrillator shocks were associated with still higher mortality risk.

Conclusions: Significant adverse prognostic association of clustered VAs is observable with even 2 VA events within 3 months and increases with higher cluster density.
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http://dx.doi.org/10.1016/j.jacep.2019.11.012DOI Listing
March 2020

Risk Factors for Infections Involving Cardiac Implanted Electronic Devices.

J Am Coll Cardiol 2019 12;74(23):2845-2854

Department of Medicine, University of Toronto, Division of Cardiology, St. Michael Hospital, Toronto, Ontario, Canada.

Background: Cardiac implantable electronic device infection is a major complication that usually requires device removal. PADIT (Prevention of Arrhythmia Device Infection Trial) was a large cluster crossover trial of conventional versus incremental antibiotics.

Objectives: This study sought to investigate independent predictors of device infection in PADIT and develop a novel infection risk score.

Methods: In brief, over 4 6-month periods, 28 centers used either conventional or incremental prophylactic antibiotic treatment in all patients. The primary outcome was hospitalization for device infection within 1 year (blinded endpoint adjudication). Multivariable logistic prediction modeling was used to identify the independent predictors and develop a risk score for device infection. The prediction models were internally validated with bootstrap methods.

Results: Device procedures were performed in 19,603 patients, and hospitalization for infection occurred in 177 (0.90%) within 1 year of follow-up. The final prediction model identified 5 independent predictors of device infection (prior procedures [P], age [A], depressed renal function [D], immunocompromised [I], and procedure type [T]) with an optimism-corrected C-statistic of 0.704 (95% confidence interval: 0.660 to 0.744). A PADIT risk score ranging from 0 to 15 points classified patients into low (0 to 4), intermediate (5 to 6) and high (≥7) risk groups with rates of hospitalization for infection of 0.51%, 1.42%, and 3.41%, respectively.

Conclusions: This study identified 5 independent predictors of device infection and developed a novel infection risk score in the largest cardiac implantable electronic device trial to date, warranting validation in an independent cohort. The 5 independent predictors in the PADIT score are readily adopted into clinical practice. (Prevention of Arrhythmia Device Infection Trial [PADIT Pilot]; NCT01002911).
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http://dx.doi.org/10.1016/j.jacc.2019.09.060DOI Listing
December 2019

Dynamic atrioventricular delay programming improves ventricular electrical synchronization as evaluated by 3D vectorcardiography.

J Electrocardiol 2020 Jan - Feb;58:1-6. Epub 2019 Oct 20.

Department of Physiology, Cardiovascular Research Institute Maastricht, Maastricht, the Netherlands. Electronic address:

Background: Optimal timing of the atrioventricular delay in cardiac resynchronization therapy (CRT) can improve synchrony in patients suffering from heart failure. The purpose of this study was to evaluate the impact of SyncAV™ on electrical synchrony as measured by vectorcardiography (VCG) derived QRS metrics during bi-ventricular (BiV) pacing.

Methods: Patients implanted with a cardiac resynchronization therapy (CRT) device and quadripolar left ventricular (LV) lead underwent 12‑lead ECG recordings. VCG metrics, including QRS duration (QRSd) and area, were derived from the ECG by a blinded observer during: intrinsic conduction, BiV with nominal atrioventricular delays (BiV Nominal), and BiV with SyncAV programmed to the optimal offset achieving maximal synchronization (BiV + SyncAV Opt).

Results: One hundred patients (71% male, 40% ischemic, 65% LBBB, 32 ± 9% ejection fraction) completed VCG assessment. QRSd during intrinsic conduction (166 ± 25 ms) was narrowed successively by BiV Nominal (137 ± 23 ms, p < .05 vs. intrinsic) and BiV + SyncAV Opt (122 ± 22 ms, p < .05 vs. BiV Nominal). Likewise, 3D QRS area during intrinsic conduction (90 ± 42 mV ∗ ms) was reduced by BiV Nominal (65 ± 39 mV ∗ ms, p < .05 vs. intrinsic) and further by BiV + SyncAV Opt (53 ± 30 mV ∗ ms, p = .06 vs. BiV Nominal).

Conclusion: With VCG-based, patient-specific optimization of the programmable offset, SyncAV reduced electrical dyssynchrony beyond conventional CRT.
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http://dx.doi.org/10.1016/j.jelectrocard.2019.09.026DOI Listing
October 2019

Effect of Direct Oral Anticoagulants, Warfarin, and Antiplatelet Agents on Risk of Device Pocket Hematoma: Combined Analysis of BRUISE CONTROL 1 and 2.

Circ Arrhythm Electrophysiol 2019 10 15;12(10):e007545. Epub 2019 Oct 15.

Department of Medicine, University of Ottawa, University of Ottawa Heart Institute, ON, Canada (P.B.N., G.A.W., D.H.B.).

Background: Oral anticoagulant use is common among patients undergoing pacemaker or defibrillator surgery. BRUISE CONTROL (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial; NCT00800137) demonstrated that perioperative warfarin continuation reduced clinically significant hematomas (CSH) by 80% compared with heparin bridging (3.5% versus 16%). BRUISE-CONTROL-2 (NCT01675076) observed a similarly low risk of CSH when comparing continued versus interrupted direct oral anticoagulant (2.1% in both groups). Using patient level data from both trials, the current study aims to: (1) evaluate the effect of concomitant antiplatelet therapy on CSH, and (2) understand the relative risk of CSH in patients treated with direct oral anticoagulant versus continued warfarin.

Methods: We analyzed 1343 patients included in BRUISE-CONTROL-1 and BRUISE-CONTROL-2. The primary outcome for both trials was CSH. There were 408 patients identified as having continued either a single or dual antiplatelet agent at the time of device surgery.

Results: Antiplatelet use (versus nonuse) was associated with CSH in 9.8% versus 4.3% of patients (<0.001), and remained a strong independent predictor after multivariable adjustment (odds ratio, 1.965; 95% CI, 1.202-3.213; =0.0071). In multivariable analysis, adjusting for antiplatelet use, there was no significant difference in CSH observed between direct oral anticoagulant use compared with continued warfarin (odds ratio, 0.858; 95% CI, 0.375-1.963; =0.717).

Conclusions: Concomitant antiplatelet therapy doubled the risk of CSH during device surgery. No difference in CSH was found between direct oral anticoagulant versus continued warfarin. In anticoagulated patients undergoing elective or semi-urgent device surgery, the patient specific benefit/risk of holding an antiplatelet should be carefully considered.

Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT00800137, NCT01675076.
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http://dx.doi.org/10.1161/CIRCEP.119.007545DOI Listing
October 2019

Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in Atrial Fibrillation (BRAIN-AF): Methods and Design.

Can J Cardiol 2019 08 7;35(8):1069-1077. Epub 2019 May 7.

Department of Medicine, Université de Montréal, Montréal, Québec, Canada.

Background: Compelling evidence showing a link between atrial fibrillation (AF) and cognitive decline and dementia is accumulating.

Methods: Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in Atrial Fibrillation (BRAIN-AF) is a prospective, multicentric, double-blind, randomized-controlled trial, recruiting patients with nonvalvular AF and a low risk of stroke. Patients with a high risk of bleeding will be excluded from the study. Participants will be randomized to receive either rivaroxaban (15 mg daily) or standard of care (placebo in patients without vascular disease or acetylsalicylic acid 100 mg daily in patients with vascular disease).

Results: The primary outcome is the composite of stroke, transient ischemic attack, and cognitive decline (defined by a decrease in the Montreal Cognitive Assessment score ≥ 3 at any follow-up visit after baseline). Approximately 3250 patients will be enrolled in approximately 130 clinical sites until 609 adjudicated primary outcome events have occurred.

Conclusions: BRAIN-AF determines whether oral anticoagulation therapy with rivaroxaban compared with standard of care reduces the risk of stroke, transient ischemic attack, or cognitive decline in patients with nonvalvular AF and a low risk of stroke.
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http://dx.doi.org/10.1016/j.cjca.2019.04.022DOI Listing
August 2019

Lead Extraction With Baffle Stenting in Adults With Transposition of the Great Arteries.

JACC Clin Electrophysiol 2019 06 27;5(6):671-680. Epub 2019 Mar 27.

Department of Medicine, Electrophysiology Service, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada; Department of Medicine, Adult Congenital Heart Disease Center, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada. Electronic address:

Objectives: This study sought to assess the feasibility, safety, and outcomes of a stepwise combined percutaneous approach that includes transvenous lead extraction (TLE) followed by baffle stenting and device reimplantation in patients with D-transposition of the great arteries (D-TGA) and atrial baffle dysfunction.

Background: Management of baffle leak or stenosis in patients with D-TGA and atrial switch surgery is challenging in the presence of transvenous cardiac implantable electronic devices. Baffle complications hinder device-related interventions and addressing baffle dysfunction often requires TLE.

Methods: All consecutive patients with D-TGA and TLE followed by a percutaneous baffle intervention at the Montreal Heart Institute between 2009 and 2018 were enrolled.

Results: Ten patients, median 38.6 years of age (range 15.2 to 50.6 years), 5 males (50.0%) were included. Procedures were performed for a device-related indication in 5 patients (50.0%) and for baffle dysfunction in 5 patients (50.0%). A total of 19 leads (17 pacing, 2 defibrillation) were targeted, with a median time from implantation of 8.7 (range 4.3 to 22.1) years. A laser sheath was most frequently required for successful TLE, which was achieved in all patients. Immediate baffle stenting was performed in 9 patients (90.0%) and immediate device reimplantation in 6 (60.0%). During a median follow-up of 3.0 (range 0.1 to 8.2) years, the only complication was subpulmonary atrioventricular valve damage requiring surgery in 1 patient, 8 months after the procedure.

Conclusions: A combined approach with TLE followed by baffle stenting and reimplantation appears to be safe and feasible in D-TGA patients with atrial switch, baffle dysfunction, and transvenous leads.
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http://dx.doi.org/10.1016/j.jacep.2019.01.023DOI Listing
June 2019

Cardiac resynchronization therapy non-responder to responder conversion rate in the more response to cardiac resynchronization therapy with MultiPoint Pacing (MORE-CRT MPP) study: results from Phase I.

Eur Heart J 2019 09;40(35):2979-2987

Université de Montréal, Montreal, Canada.

Aims: To assess the impact of MultiPoint™ Pacing (MPP)-programmed according to the physician's discretion-in non-responders to standard biventricular pacing after 6 months.

Methods And Results: The study enrolled 1921 patients receiving a quadripolar cardiac resynchronization therapy (CRT) system capable of MPP™ therapy. A core laboratory assessed echocardiography at baseline and 6 months and defined volumetric non-response to biventricular pacing as <15% reduction in left ventricular end-systolic volume (LVESV). Clinical sites randomized patients classified as non-responders in a 1:1 ratio to receive MPP (236 patients) or continued biventricular pacing (231 patients) for an additional 6 months and evaluated rate of conversion to echocardiographic response. Baseline characteristics of both groups were comparable. No difference was observed in non-responder to responder conversion rate between MPP and biventricular pacing (31.8% and 33.8%, P = 0.72). In the MPP arm, 68 (29%) patients received MPP programmed with a wide LV electrode anatomical separation (≥30 mm) and shortest LV1-LV2 and LV2-RV timing delays (MPP-AS); 168 (71%) patients received MPP programmed with other settings (MPP-Other). MPP-AS elicited a significantly higher non-responder conversion rate compared to MPP-Other (45.6% vs. 26.2%, P = 0.006) and a trend in a higher conversion rate compared to biventricular pacing (45.6% vs. 33.8%, P = 0.10).

Conclusions: After 6 months, investigator-discretionary MPP programming did not significantly increase echocardiographic response compared to biventricular pacing in CRT non-responders.
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http://dx.doi.org/10.1093/eurheartj/ehz109DOI Listing
September 2019

Benefits of Multisite/Multipoint Pacing to Improve Cardiac Resynchronization Therapy Response.

Card Electrophysiol Clin 2019 03;11(1):99-114

Department of Cardiology, Montréal Heart Institute, University of Montréal, 5000 Bélanger Street, Montréal, Québec, H1T 1C8, Canada.

This article provides a general overview of the underlying mechanisms that support pacing from more discrete points and/or a wider vector (multisite and multipoint pacing) to improve left ventricular resynchronization. We performed a critical overview of the current literature and to identify some remaining knowledge gaps to spur further research. It was not our goal to provide a systematic review with a comprehensive bibliography, but rather to focus on selected publications that, in our opinion, have either expertly reviewed a specific aspect of cardiac resynchronization therapy or have been landmark studies in the field.
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http://dx.doi.org/10.1016/j.ccep.2018.11.016DOI Listing
March 2019

Dynamic programming of atrioventricular delay improves electrical synchrony in a multicenter cardiac resynchronization therapy study.

Heart Rhythm 2019 07 23;16(7):1047-1056. Epub 2019 Jan 23.

Section of Cardiac Electrophysiology, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.

Background: Patient-specific programming of cardiac resynchronization therapy (CRT) is often neglected, despite significant nonresponse rates. The device-based SyncAV CRT algorithm dynamically adjusts atrioventricular delays to the intrinsic AV interval, reduced by a programmable offset, to accommodate each patient's changing needs.

Objective: The purpose of this study was to evaluate the acute effect of biventricular (BiV) pacing enhanced by SyncAV on electrical synchrony in a broad patient population.

Methods: Patients with existing CRT implants were prospectively evaluated at 5 international centers. Blinded 12-lead electrocardiographic QRS duration (QRSd) measurements were used to compare intrinsic conduction with nominal BiV pacing, BiV + SyncAV (default 50 ms offset), and BiV + SyncAV (optimized, patient-specific offset). BiV configurations were tested twice using the latest activating and earliest activating left ventricular (LV) electrodes as cathodes.

Results: Ninety patients (mean age 67.1 ± 9.5 years; 67 (74%) men; 55 (63%) with left bundle branch block; 37 (43%) with ischemic cardiomyopathy; LV ejection fraction 32% ± 9%) with intact atrioventricular conduction (PR interval 195 ± 45 ms) were enrolled. With BiV pacing from the latest activating LV electrode, the intrinsic QRSd of 155 ± 29 ms was reduced by 9% ± 20% to 138 ± 27 ms using traditional BiV pacing and by 13% ± 14% to 133 ± 25 ms using BiV + SyncAV (50 ms offset). The maximal QRSd reduction by 20% ± 10% to 123 ± 22 ms was achieved by BiV + SyncAV with an optimized offset. Similar QRSd reductions were observed with BiV pacing from the earliest activating LV electrode across all settings. Of all baseline characteristics, intrinsic QRSd was the only significant predictor of QRSd reduction magnitude.

Conclusion: SyncAV improved acute electrical synchrony beyond conventional CRT, particularly with patient-specific optimization. The degree of synchrony restored was contingent on intrinsic QRSd, but not limited by other baseline characteristics or by the LV pacing electrode used.
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http://dx.doi.org/10.1016/j.hrthm.2019.01.020DOI Listing
July 2019

Rationale and design of a randomized clinical trial to assess the safety and efficacy of multipoint pacing therapy: MOre REsponse on Cardiac Resynchronization Therapy with MultiPoint Pacing (MORE-CRT MPP-PHASE II).

Am Heart J 2019 03 8;209:1-8. Epub 2018 Dec 8.

Université de Montréal, Montreal, Canada.

Background: Although cardiac resynchronization therapy (CRT) is beneficial in most heart failure patients, up to 40% do not respond to CRT. Data from the MultiPoint Pacing (MPP) IDE trial and MORE-CRT MPP-PHASE I study suggest improved response in subjects in the MPP arm-programmed with wide left ventricular (LV) electrode anatomical separation (≥30 mm) and shortest timing delays of 5 milliseconds (MPP-AS)-compared with quadripolar biventricular (BiV) pacing.

Study Design: The MORE-CRT MPP-PHASE II trial is a prospective, randomized, multicenter study to assess the 6-month impact of MPP programmed to mandated MPP-AS settings in subjects who do not respond to 6 months of BiV pacing (MPP OFF). Approximately 5,000 subjects with a standard CRT indication will be enrolled and implanted with a quadripolar CRT system (Abbott) capable of delivering MPP. Only BiV pacing is activated at implant. At 6 months, subjects classified as CRT nonresponders (<15% reduction in LV end-systolic volume) are randomized (1:1) to MPP or continued BiV pacing. The mandated MPP parameters (eg, MPP-AS) are programmed to subjects randomized to the MPP arm. At 12 months, the 2 groups will be compared to determine if there is a difference in CRT response rate.

Conclusions: This trial will evaluate whether MPP programmed to mandated MPP-AS settings improves LV reverse remodeling and clinical response to CRT in patients who fail to respond to 6 months of BiV pacing (www.clinicaltrials.gov identifier NCT02006069).
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http://dx.doi.org/10.1016/j.ahj.2018.12.004DOI Listing
March 2019

Prevention of Arrhythmia Device Infection Trial: The PADIT Trial.

J Am Coll Cardiol 2018 12;72(24):3098-3109

Division of Cardiology, Libin Cardiovascular Institute of Alberta, University of Calgary, Calgary, Alberta, Canada.

Background: Infection of implanted medical devices has catastrophic consequences. For cardiac rhythm devices, pre-procedural cefazolin is standard prophylaxis but does not protect against methicillin-resistant gram-positive organisms, which are common pathogens in device infections.

Objective: This study tested the clinical effectiveness of incremental perioperative antibiotics to reduce device infection.

Methods: The authors performed a cluster randomized crossover trial with 4 randomly assigned 6-month periods, during which centers used either conventional or incremental periprocedural antibiotics for all cardiac implantable electronic device procedures as standard procedure. Conventional treatment was pre-procedural cefazolin infusion. Incremental treatment was pre-procedural cefazolin plus vancomycin, intraprocedural bacitracin pocket wash, and 2-day post-procedural oral cephalexin. The primary outcome was 1-year hospitalization for device infection in the high-risk group, analyzed by hierarchical logistic regression modeling, adjusting for random cluster and cluster-period effects.

Results: Device procedures were performed in 28 centers in 19,603 patients, of whom 12,842 were high risk. Infection occurred in 99 patients (1.03%) receiving conventional treatment, and in 78 (0.78%) receiving incremental treatment (odds ratio: 0.77; 95% confidence interval: 0.56 to 1.05; p = 0.10). In high-risk patients, hospitalization for infection occurred in 77 patients (1.23%) receiving conventional antibiotics and in 66 (1.01%) receiving incremental antibiotics (odds ratio: 0.82; 95% confidence interval: 0.59 to 1.15; p = 0.26). Subgroup analysis did not identify relevant patient or site characteristics with significant benefit from incremental therapy.

Conclusions: The cluster crossover design efficiently tested clinical effectiveness of incremental antibiotics to reduce device infection. Device infection rates were low. The observed difference in infection rates was not statistically significant. (Prevention of Arrhythmia Device Infection Trial [PADIT Pilot] [PADIT]; NCT01002911).
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http://dx.doi.org/10.1016/j.jacc.2018.09.068DOI Listing
December 2018

Atrial fibrillation in young patients.

Expert Rev Cardiovasc Ther 2018 Jul 2;16(7):489-500. Epub 2018 Jul 2.

a Electrophysiology Service , Montreal Heart Institute, Université de Montréal , Montreal , Canada.

Introduction: Atrial fibrillation (AF) is the most frequent arrhythmia worldwide. While mostly seen in elderly, it can also affect young adults (≤ 45 years of age), older adolescent, and children. Areas covered: The aim of this review is to provide an overview of the current management of AF in young patients. Specific issues arise over diagnostic workup as well as antiarrhythmic and anticoagulation therapies. The future management and diagnostic strategies are also discussed. Expert commentary: Management of AF in the young adult is largely extrapolated from adult studies and guidelines. In this population, AF could reveal a genetic pathology (e.g. Brugada, Long QT or Short QT syndromes) or be the initial presentation of a cardiomyopathy. Therefore, thorough workup in the young population to eliminate potential malignant pathology.
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http://dx.doi.org/10.1080/14779072.2018.1490644DOI Listing
July 2018

Canadian Registry of Implantable Electronic Device Outcomes: Surveillance of High-Voltage Leads.

Can J Cardiol 2018 06 19;34(6):808-811. Epub 2018 Feb 19.

Cardiovascular Research Methods Center, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.

Background: Cardiac implantable electrical devices (CIEDs) are subject to advisories and complications that can result in morbidity and mortality for patients; there is currently no system in Canada to track these.

Methods: This was a multicenter, prospective cohort study conducted at 5 centers to determine feasibility. Patients with a de novo high-voltage (HV) lead implantation were included and followed for a minimum of 1 year.

Results: There were 611 leads enrolled into the registry over 18 months. The mean age was 62.4 ± 12.8 years; 144 (23.6%) women were enrolled. The indication for lead implantation was for primary prevention in 65.5%. There were 497 (82.1%) de novo devices (single chamber: 54.5%, dual chamber: 20.5%, cardiac resynchronization therapy [CRT] 25.0%); the remainder of the procedures was a system revision for either upgrade (8.1%) or lead revision (9.8%). The lead revision rate at 1 year was 3.4%, with the primary reason being lead dislodgements. Mortality rate was 3.8% at 1 year. The rate of any device-related complication was 2.0% at 30 days, with the highest rate in CRT implants (4.9%, P = 0.0105). At 1 year, the complication rate was 4.5%, with no significant difference among device types.

Conclusions: This study demonstrates that device surveillance is feasible and highlights (1) the need for CIED surveillance to track device-related complications, (2) the scope of this should be larger, and (3) mandatory participation should be considered. This system could predict CIEDs that may be susceptible to higher than usual rates of failure, mitigating adverse outcomes in patients.
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http://dx.doi.org/10.1016/j.cjca.2018.02.009DOI Listing
June 2018

Differentiating Ventricular From Supraventricular Arrhythmias Using the Postpacing Interval After Failed Antitachycardia Pacing.

Circ Arrhythm Electrophysiol 2018 04;11(4):e005921

Heart Rhythm Service, University of British Columbia, Vancouver, Canada (M.T.B., J.G.A., A.D.K.); University of Toronto, Ontario, Canada (N.L.); Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia, Canada (J.S., R.P., M.G.); Hamilton Health Sciences Center, Ontario, Canada (J.S.H.); Montreal Heart Institute, Quebec, Canada (B.T.); Royal Jubilee Hospital, Victoria, British Columbia, Canada (L.S.); McGill, Montreal, Quebec, Canada (V.E.); University of Ottawa, Ontario, Canada (D.B., P.N.); University of Alberta, Edmonton, Canada (S.S.); University of Western Ontario, London, Ontario, Canada (A.T.).

Background: Implantable cardioverter defibrillator arrhythmia discrimination algorithms often are unable to discriminate ventricular from supraventricular arrhythmias. We sought to evaluate whether the response to antitachycardia pacing (ATP) in patients with an implantable cardioverter defibrillator could further discriminate ventricular from supraventricular arrhythmias in patients receiving ATP.

Methods And Results: All episodes of ventricular or supraventricular tachycardia where ATP was delivered in patients enrolled in RAFT (Cardiac-Resynchronization Therapy for Mild-to-Moderate Heart Failure Trial) were included. RAFT randomized 1798 patients with New York Heart Association class II/III heart failure, left ventricular ejection fraction ≤30%, and QRS duration of ≥120 ms to a implantable cardioverter defibrillator±cardiac resynchronization therapy. The tachycardia cycle lengths (TCLs) before and after the delivery of ATP and the postpacing intervals were assessed. Overall, 10 916 ATP attempts were reviewed for 8150 tachycardia episodes in 924 patients. After excluding tachycardias where ATP terminated the episode or where the specific mechanism of the tachycardia was uncertain, we analyzed 3676 ATP attempts delivered for 2046 tachycardia episodes in 541 patients. A shorter difference between postpacing interval and TCL (PPI-TCL) was more likely to be associated with ventricular tachycardia than with supraventricular tachyarrhythmia (138.1±104.2 versus 277.4±126.9 ms; <0.001). Analysis of the receiver operator curve for the PPI-TCL revealed an area under the curve of 0.803 (<0.001; 95% confidence interval, 0.784-0.822). The majority of tachycardias with a PPI-TCL >360 ms were supraventricular with a PPI-TCL value of ≤360 ms having a sensitivity of 97.4% and specificity of 28.3% for ventricular tachycardia.

Conclusions: The ATP response, specifically the PPI-TCL, can further discriminate ventricular from supraventricular arrhythmias in patients with implantable cardioverter defibrillators when the currently available discriminators fail.

Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00251251.
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http://dx.doi.org/10.1161/CIRCEP.117.005921DOI Listing
April 2018

Transvenous Lead Extraction in Adults With Congenital Heart Disease: Insights From a 20-Year Single-Center Experience.

Circ Arrhythm Electrophysiol 2018 02;11(2):e005409

From the Department of Medicine (J.-B.G., M.-A.C., P.P., M.D., B.T., N.C.P., A.D., F.M., F.-P.M., A.W.A., R.I., P.K., B.M.), Adult Congenital Heart Disease Center (M.-A.C., N.C.P., A.D., F.M., F.-P.M., A.W.A., R.I., P.K., B.M.), and Coordination Center (A.S.), Montreal Heart Institute, Université de Montréal, Canada.

Background: Safety and feasibility data on transvenous lead extraction (TLE) in the challenging population of adults with congenital heart disease (A-CHD) are limited. Herein, we report the results of TLE in A-CHD during a 20-year period.

Methods And Results: All consecutive TLE procedures in A-CHD were included in a monocentric prospective registry from 1996. A total of 121 leads were extracted in 49 A-CHD (median age, 38 years; 51% men) during 71 TLE procedures. Twenty-four (49%) patients had transposition of the great arteries. Main indications for extraction were infection in 34 (48%) and lead failure in 22 (31%). A laser sheath was required for 56 (46%) leads and a femoral approach for 10 (8%). Complete TLE was achieved for 111 leads (92%). In multivariable analysis, lead duration (odds ratio, 1.02; 95% confidence interval, 1.00-1.04; <0.01) and number of previous cardiac surgeries (odds ratio, 2.65; 95% confidence interval, 1.52-4.67; <0.01) were predictive of TLE failure. No perioperative death or pericardial effusion was observed. Subpulmonary atrioventricular valve regurgitation increased in 8 patients (5 with transposition of the great arteries) and was independently associated with an implantable cardioverter defibrillator lead (odds ratio, 9.69; 95% confidence interval, 1.31-71.64; =0.03) and valvular vegetation (odds ratio, 7.29; 95% confidence interval, 1.32-40.51; =0.02). After a median of 54 (19-134) months of follow-up after the first TLE, 3 deaths occurred independently from lead management.

Conclusions: Despite complex anatomic issues, TLE can be achieved successfully in most A-CHD using advanced extraction techniques. Subpulmonary atrioventricular valve regurgitation is a prevalent complication, particularly in patients with transposition of the great arteries.
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http://dx.doi.org/10.1161/CIRCEP.117.005409DOI Listing
February 2018

Programming Cardiac Resynchronization Therapy for Electrical Synchrony: Reaching Beyond Left Bundle Branch Block and Left Ventricular Activation Delay.

J Am Heart Assoc 2018 02 6;7(3). Epub 2018 Feb 6.

Abbott, Sylmar, CA.

Background: QRS narrowing following cardiac resynchronization therapy with biventricular (BiV) or left ventricular (LV) pacing is likely affected by patient-specific conduction characteristics (PR, qLV, LV-paced propagation interval), making a universal programming strategy likely ineffective. We tested these factors using a novel, device-based algorithm (SyncAV) that automatically adjusts paced atrioventricular delay (default or programmable offset) according to intrinsic atrioventricular conduction.

Methods And Results: Seventy-five patients undergoing cardiac resynchronization therapy (age 66±11 years; 65% male; 32% with ischemic cardiomyopathy; LV ejection fraction 28±8%; QRS duration 162±16 ms) with intact atrioventricular conduction (PR interval 194±34, range 128-300 ms), left bundle branch block, and optimized LV lead position were studied at implant. QRS duration (QRSd) reduction was compared for the following pacing configurations: nominal simultaneous BiV (Mode I: paced/sensed atrioventricular delay=140/110 ms), BiV+SyncAV with 50 ms offset (Mode II), BiV+SyncAV with offset that minimized QRSd (Mode III), or LV-only pacing+SyncAV with 50 ms offset (Mode IV). The intrinsic QRSd (162±16 ms) was reduced to 142±17 ms (-11.8%) by Mode I, 136±14 ms (-15.6%) by Mode IV, and 132±13 ms (-17.8%) by Mode II. Mode III yielded the shortest overall QRSd (123±12 ms, -23.9% [<0.001 versus all modes]) and was the only configuration without QRSd prolongation in any patient. QRS narrowing occurred regardless of QRSd, PR, or LV-paced intervals, or underlying ischemic disease.

Conclusions: Post-implant electrical optimization in already well-selected patients with left bundle branch block and optimized LV lead position is facilitated by patient-tailored BiV pacing adjusted to intrinsic atrioventricular timing using an automatic device-based algorithm.
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http://dx.doi.org/10.1161/JAHA.117.007489DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5850248PMC
February 2018

Quality of life with ablation or medical therapy for ventricular arrhythmias: A substudy of VANISH.

J Cardiovasc Electrophysiol 2018 03 30;29(3):421-434. Epub 2018 Jan 30.

Department of Medicine, QEII Health Sciences Centre and Dalhousie University, Halifax, Nova Scotia, Canada.

Background/objective: We compared health-related quality of life (HRQoL) in patients randomized to escalated therapy and those randomized to ablation for ventricular tachycardia in the VANISH trial.

Methods: HRQoL was assessed among VANISH patients at baseline and 3-, 6-, and 12-month follow-up visits. Four validated instruments were used: the SF-36, the implanted cardioverter defibrillator (ICD) Concerns questionnaire (ICDC), the Hospital Anxiety and Depression Scale (HADS), and the EuroQol five dimensions questionnaire (EQ-5D). Linear mixed-effects modeling was used for repeated measures with SF-36, HADS, ICDC, and EQ-5D as dependent variables. In a second model, treatment was subdivided by amiodarone use prior to enrollment.

Results: HRQoL did not differ significantly between those randomized to ablation or escalated therapy. On subgroup analysis, improvement in SF-36 measures was seen at 6 months in the ablation group for social functioning (63.5-69.3, P = 0.03) and energy/fatigue (43.0-47.9, P = 0.01). ICDC measures showed a reduction in ICD concern in the ablation group at 6 months (10.4-8.7, P = 0.01) and a reduction in ICD concern in the escalated therapy group at 6 months (10.9-9.4, P = 0.04). EQ-5D measures showed a significant improvement in overall health in ablation patients at 6 months (63.4-67.3, P = 0.04).

Conclusion: Patients in the VANISH study randomized to ablation did not have a significant change in quality of life outcomes compared to those randomized to escalated therapy. Some subgroup findings were significant, as those randomized to ablation showed persistent improvement in SF-36 energy/fatigue and ICD concern, and transient improvement in SF-36 social functioning and EQ-5D overall health.
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http://dx.doi.org/10.1111/jce.13419DOI Listing
March 2018

Canadian Registry of Implantable Electronic Device Outcomes: Longer-term follow-up of the Riata lead under advisory.

Heart Rhythm 2018 04 2;15(4):524-529. Epub 2017 Dec 2.

Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada.

Background: The Riata lead advisory was announced in 2011 and has posed unique management challenges because of cable externalization and insulation abrasion, in some cases leading to sudden loss of defibrillation.

Objective: The purpose of this study was to provide further data on the rate of electrical failure in a population of patients with a Riata lead under advisory.

Methods: Using the Canadian Registry of Electronic Device Outcomes, prospective follow-up data were collected on 1352 Riata leads under advisory in 17 implantable cardioverter-defibrillator (ICD) implantation centers in Canada. Data on electrical and structural failure were collected, as well as periprocedural complications related to lead revision (abandonment or extraction).

Results: Of the 1352 leads included in this 12-month follow-up cohort, 110 leads were revised. Mean follow-up time was 10.4 ± 1.5 years. The 12-year rate of electrical failure for the 8Fr lead was 9.45%, whereas the 10-year failure rate for the 7Fr lead was 7.25% and was not found to be accelerating. Of the leads revised because of advisory only (patient preference, advisory related, electrical or structural failure), the majority were abandoned (n = 54 [76.0%]), whereas 17 (24.0%) were extracted using power tools. The rate of major complications in each group was 5.6% and 5.9%, respectively.

Conclusion: This report provides further data on the risk of electrical lead failure over a long lead dwell time. The risk of failure exceeds the risk of periprocedural major complications, indicating that the risk-to-benefit ratio is favorable to revise the lead in appropriate clinical scenarios.
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http://dx.doi.org/10.1016/j.hrthm.2017.11.033DOI Listing
April 2018

Reducing radiation exposure during procedures performed in the electrophysiology laboratory.

J Cardiovasc Electrophysiol 2018 02 17;29(2):308-315. Epub 2017 Nov 17.

Electrophysiology Service, Montreal Heart Institute and the Department of Medicine, Université de Montréal, Montréal, Canada.

Introduction: Expert societies recently published strong recommendations to reduce the exposure of patients and staff to ionizing radiation (IR) during interventional and electrophysiology (EP) procedures. However, adherence to these guidelines remains difficult and the impact of implementing such recommendations is poorly characterized.

Methods And Results: We conducted a single-center cohort study to quantify radiation exposure over time in three EP laboratories at the Montreal Heart Institute during 5,546 consecutive procedures from 2012 to 2015 by 11 primary operators. Overall, 2,618 (47.2%) procedures were catheter-based and 2,928 (52.8%) were device interventions. Interventions to reduce radiation exposure included educational initiatives to raise awareness (i.e., limiting cine acquisition, patient position, table height), slower frame rate, lower radiation dose per pulse, collimation, and integration with 3-D mapping systems and/or MediGuide technology. An 85% reduction in IR exposure was observed from 2012 to 2015, with the mean dose-area-product (DAP) decreasing from 7.65 ± 0.05 Gy·cm to 1.15 ± 0.04 Gy·cm (P < 0.001). This was true for catheter-based procedures (mean DAP 16.99 ± 0.08 to 2.00 ± 0.06 Gy·cm , P < 0.001) and device interventions (mean DAP 4.18 ± 0.06 to 0.64 ± 0.05 Gy·cm , P < 0.001). The median effective dose of IR recorded per quarter by 282 cervical dosimeters on EP staff decreased from 0.57 (IQR 0.18, 1.03) mSv in 2012 to 0.00 (IQR 0.00, 0.19) mSv in 2015, P < 0.001.

Conclusion: Enforcing good clinical practices with simple measures and low-dose fluoroscopy settings are highly effective in reducing IR exposure in the EP lab. These promising results should encourage other EP labs to adopt similar protective measures.
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http://dx.doi.org/10.1111/jce.13373DOI Listing
February 2018

Impact of Left Ventricular vs Biventricular Pacing on Reverse Remodelling: Insights From the Evaluation of Resynchronization Therapy for Heart Failure (EARTH) Trial.

Can J Cardiol 2017 10 31;33(10):1274-1282. Epub 2017 Jul 31.

Department of Medicine, Montreal Heart Institute, Montreal, Québec, Canada. Electronic address:

Background: Studies comparing biventricular (BiV) cardiac resynchronization therapy (CRT) and left ventricular (LV) pacing alone have yielded conflicting results. We recently reported the results of the Greater Evaluation of Resynchronization Therapy for Heart Failure (GREATER-EARTH) trial demonstrating similar clinical benefits of BiV and LV-CRT on exercise tolerance. We report the prespecified secondary outcomes of the GREATER-EARTH trial, comparing the impact of BiV vs LV-CRT on structural and biochemical cardiac remodelling.

Methods: Patients with a LV ejection fraction (LVEF) ≤ 35% and a QRS duration ≥ 120 ms were randomized to BiV-CRT or LV-CRT for a 6-month period, followed by crossover. The primary end point was a change in LV end-systolic volume (LVESV). Secondary end points included changes in LVEF, right ventricular (RV) dimensions and function, mitral regurgitation (MR), indices of diastolic function, systolic pulmonary artery pressure (sPAP), and disease-specific biomarkers.

Results: One hundred twenty patients (60.9 ± 8.8 years; 75.0% men; LVEF, 24.4% ± 6.3%) were enrolled. A similar reduction in LVESV was observed, from a baseline of 162.4 ± 57.2 mL to 130.4 ± 63.4 mL with BiV pacing and 130.3 ± 59.9 mL with LV pacing (P = 0.679, BiV pacing vs LV pacing). Improvements in LVEF, RV remodelling, and N-terminal pro b-type natriuretic peptide were similar between groups. BiV pacing yielded superior outcomes with respect to LV diastolic function, indexed left atrial volume, degree of MR, and sPAP (all P < 0.05), together with decreased N-terminal propeptide of type III collagen with LV-CRT.

Conclusions: In this randomized double-blind crossover trial, BiV and LV pacing resulted in similar improvements in the primary LV remodelling end point (LVESV). Analyses of secondary end points revealed advantages of BiV pacing over LV pacing on several other features of cardiac remodelling, providing mechanistic insights to support the main finding of the GREATER-EARTH trial.
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http://dx.doi.org/10.1016/j.cjca.2017.07.478DOI Listing
October 2017

Increasing Prevalence of Atrial Fibrillation and Permanent Atrial Arrhythmias in Congenital Heart Disease.

J Am Coll Cardiol 2017 Aug;70(7):857-865

Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada; Montreal Health Innovations Coordinating Center (MHICC), Montreal, Quebec, Canada. Electronic address:

Background: Atrial arrhythmias are the most common complication encountered in the growing and aging population with congenital heart disease.

Objectives: This study sought to assess the types and patterns of atrial arrhythmias, associated factors, and age-related trends.

Methods: A multicenter cohort study enrolled 482 patients with congenital heart disease and atrial arrhythmias, age 32.0 ± 18.0 years, 45.2% female, from 12 North American centers. Qualifying arrhythmias were classified by a blinded adjudicating committee.

Results: The most common presenting arrhythmia was intra-atrial re-entrant tachycardia (IART) (61.6%), followed by atrial fibrillation (28.8%), and focal atrial tachycardia (9.5%). The proportion of arrhythmias due to IART increased with congenital heart disease complexity from 47.2% to 62.1% to 67.0% in patients with simple, moderate, and complex defects, respectively (p = 0.0013). Atrial fibrillation increased with age to surpass IART as the most common arrhythmia in those ≥50 years of age (51.2% vs. 44.2%; p < 0.0001). Older age (odds ratio [OR]: 1.024 per year; 95% confidence interval [CI]: 1.010 to 1.039; p = 0.001) and hypertension (OR: 2.00; 95% CI: 1.08 to 3.71; p = 0.029) were independently associated with atrial fibrillation. During a mean follow-up of 11.3 ± 9.4 years, the predominant arrhythmia pattern was paroxysmal in 62.3%, persistent in 28.2%, and permanent in 9.5%. Permanent atrial arrhythmias increased with age from 3.1% to 22.6% in patients <20 years to ≥50 years, respectively (p < 0.0001).

Conclusions: IART is the most common presenting atrial arrhythmia in patients with congenital heart disease, with a predominantly paroxysmal pattern. However, atrial fibrillation increases in prevalence and atrial arrhythmias progressively become permanent as the population ages.
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http://dx.doi.org/10.1016/j.jacc.2017.06.034DOI Listing
August 2017

Ablation of a symptomatic spontaneous automatic focus arising from an atriofascicular fiber.

HeartRhythm Case Rep 2016 Sep 4;2(5):379-383. Epub 2016 May 4.

Electrophysiology Department of the Montreal Heart Institute and Université de Montréal, Montreal, Quebec, Canada.

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http://dx.doi.org/10.1016/j.hrcr.2016.04.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5419942PMC
September 2016

Additional electrodes on the Quartet™ LV lead provide more programmable pacing options than bipolar and tripolar equivalents.

Europace 2017 Apr;19(4):588-595

Baptist Health, Lexington, KY, USA.

Aims: The aim of this study was to evaluate any benefits to the number of viable pacing vectors and maximal spatial coverage with quadripolar left ventricular (LV) leads when compared with tripolar and bipolar equivalents in patients receiving cardiac resynchronization therapy (CRT).

Methods And Results: A meta-analysis of five previously published clinical trials involving the Quartet™ LV lead (St Jude Medical, St Paul, MN, USA) was performed to evaluate the number of viable pacing vectors defined as capture thresholds ≤2.5 V and no phrenic nerve stimulation and maximal spatial coverage of viable vectors in CRT patients at pre-discharge (n = 370) and first follow-up (n = 355). Bipolar and tripolar lead configurations were modelled by systematic elimination of two and one electrode(s), respectively, from the Quartet lead. The Quartet lead with its four pacing electrodes exhibited the greatest number of pacing vectors per patient when compared with the best bipolar and the best tripolar modelled equivalents. Similarly, the Quartet lead provided the highest spatial coverage in terms of the distance between two furthest viable pacing cathodes when compared with the best bipolar and the best tripolar configurations (P < 0.05). Among the three modelled bipolar configurations, the lead configuration with the two most distal electrodes resulted in the highest number of viable pacing vectors. Among the four modelled tripolar configurations, elimination of the second proximal electrode (M3) resulted in the highest number of viable pacing options per patient. There were no significant differences observed between pre-discharge and first follow-up analyses.

Conclusion: The Quartet lead with its four electrodes and the capability to pace from four anatomical locations provided the highest number of viable pacing vectors at pre-discharge and first follow-up visits, providing more flexibility in device programming and enabling continuation of CRT in more patients when compared with bipolar and tripolar equivalents.
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April 2017

Cardiac Resynchronization Therapy Reduces Ventricular Arrhythmias in Primary but Not Secondary Prophylactic Implantable Cardioverter Defibrillator Patients: Insight From the Resynchronization in Ambulatory Heart Failure Trial.

Circ Arrhythm Electrophysiol 2017 Mar;10(3)

From the Department of Medicine, Division of Cardiology, Dalhousie University, Halifax, NS, Canada (J.L.S., R.P., M.J.G.); Department of Medicine (G.A.W.), Cardiovascular Research Methods Centre (E.Y.), and Department of Medicine, Division of Cardiology (D.B., P.B.N.), University of Ottawa Heart Institute, ON, Canada; Department of Medicine, Division of Cardiology, Population Health Research Institute, Hamilton, ON, Canada (J.S.H.); Department of Medicine, Montreal Heart Institute, QC, Canada (B.T.); Department of Medicine, Division of Cardiology, Royal Jubilee Hospital, Victoria, BC, Canada (L.D.S.); Department of Medicine, Division of Cardiology, University of Alberta, Edmonton, Canada (S.S.); Department of Medicine, Division of Cardiology, McGill University Health Centre and Hopital Sacre Coeur de Montreal, Quebec, Canada (V.E.); Department of Medicine, Division of Cardiology, University of Toronto, ON, Canada (P.D.); and Division of Cardiology, Department of Medicine, Western University, London, Canada (A.S.L.T.).

Background: The RAFT (Resynchronization in Ambulatory Heart Failure Trial) demonstrated that cardiac resynchronization therapy (CRT) reduced both mortality and heart failure hospitalizations in patients with functional class II or III heart failure and widened QRS. We examined the influence of CRT on ventricular arrhythmias in patients with primary versus secondary prophylaxis defibrillator indications.

Methods And Results: All ventricular arrhythmias among RAFT study participants were downloaded and adjudicated by 2 blinded reviewers with an overreader for disagreements and committee review for remaining discrepancies. Incidence of ventricular arrhythmias among patients randomized to CRT-D versus implantable cardioverter defibrillator (ICD) were compared within the groups of patients treated for primary prophylaxis and for secondary prophylaxis. Of 1798 enrolled patients, 1764 had data available for adjudication and were included. Of these, 1531 patients were implanted for primary prophylaxis, while 233 patients were implanted for secondary prophylaxis; 884 patients were randomized to ICD and 880 to CRT-D. During 5953.6 patient-years of follow-up, there were 11 278 appropriate ICD detections of ventricular arrhythmias. In the primary prophylaxis group, CRT-D significantly reduced incidence ventricular arrhythmias in comparison to ICD (hazard ratio, 0.86; 95% confidence interval, 0.74-0.99; =0.044). This effect was not seen in the secondary prophylaxis group (hazard ratio, 1.14; 95% confidence interval, 0.82-1.58; =0.45). CRT-D was not associated with significant differences in overall ventricular arrhythmia burden in either group.

Conclusions: CRT reduced the rate of onset of new ventricular arrhythmias detected by ICDs in patients without a history of prior ventricular arrhythmias. This effect was not observed among patients who had prior ventricular arrhythmias.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00251251.
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http://dx.doi.org/10.1161/CIRCEP.116.004875DOI Listing
March 2017