Leucocyte-derived micro-RNAs as candidate biomarkers in Brugada syndrome.

AIMS: Risk stratification for sudden cardiac death in patients with Brugada syndrome remains a major challenge. Contemporary risk prediction models have only modest predictive value. The aim of this study was to assess the role of micro-RNAs from peripheral blood as candidate biomarkers in Brugada syndrome. METHODS AND RESULTS: In this prospective study, Brugada patients and unaffected control individuals were enrolled for analysis of leucocyte-derived microRNAs (miRNAs) levels. Expression levels of 798 different circulating miRNAs were analysed on the NanoString® nCounter platform. All results were cross-validated by using a quantitative polymerase chain reaction. Micro-RNA expression levels of Brugada patients were compared with clinical data. A total of 21 definite Brugada patients (38% with a history of ventricular arrhythmia or cardiac arrest) and 30 unaffected control individuals were included in the study. Micro-RNA analysis showed a distinct expression profile in Brugada patients with 42 differentially expressed markers (38 up-regulated, 4 down-regulated miRNAs). The symptom status of Brugada patients was associated with a distinct miRNA signature. Micro-RNAs 145-5p and 585-3p were significantly up-regulated in symptomatic Brugada patients (P = 0.04). Incorporating miRNAs 145-5p and 585-3p into a multivariable model demonstrated significantly increased symptom prediction (area under the curve = 0.96; 95% confidence interval: 0.88-1.00). CONCLUSION: Brugada patients display a distinct miRNA expression profile compared with unaffected control individuals. There is also evidence that certain miRNAs (miR-145-5p and miR-585-3p) are associated with the symptom status of Brugada patients. The results suggest the principal utility of leucocyte-derived miRNAs as prognostic biomarkers for Brugada syndrome.

Safety of Cefazolin Test Dose in Patients With Penicillin Allergy Just Prior to Cardiac Device Implantation: A Single-Centre Experience.

Background: Cephalosporins are the cornerstone of cardiac device infection prophylaxis. Owing to fears of cross-reactivity, penicillin-allergic patients are exposed to potentially more-toxic drugs, with decreased efficacy. We evaluated the safety of a cefazolin test dose (CTD) in self-reported penicillin-allergic patients. Methods: In this single-centre study, we evaluated consecutive patients with chart documentation of penicillin allergy undergoing cardiac device implantation, over a 2-year period. A CTD was performed if no cephalosporin allergy or severe anaphylactic reaction to penicillin had been documented. Patients were given 2 doses of 100 mg IV cefazolin, and if no allergic reaction occurred after 5 minutes, the full dose (1800 mg) was administered in the electrophysiology laboratory just before the implantation procedure. Results: A total of 2200 patients were included. The frequency of reported penicillin allergy was 9.3% (n = 204). In 80% of cases, the type of allergic reaction was not reported in medical notes or was unknown by the patient. A CTD was performed in 67.6% of patients with a penicillin allergy (n = 138). A total of 5 adverse events occurred (3.6% of patients [95% confidence interval, 1.1%-6.1%]) - 4 skin rashes and 1 tongue edema. These 5 patients became asymptomatic after antihistaminic and corticosteroid IV treatment. Even if the test dose was negative, 79% of patients also were administered vancomycin before the procedure, as it requires a 1-hour infusion prior to the CTD in the implantation procedure room. Conclusion: A CTD in most penicillin-allergic patients appears to be safe and allows its use per recommended guidelines.

Contexte: Les céphalosporines sont la pierre angulaire de la prophylaxie des infections des dispositifs cardiaques. En raison du risque appréhendé de réactivité croisée, les patients allergiques à la pénicilline se trouvent exposés à des médicaments potentiellement plus toxiques, qui s'avèrent aussi moins efficaces. Nous avons évalué l'innocuité d'une dose d'essai de céfazoline chez des patients qui s'étaient dits allergiques à la pénicilline. Méthodologie: Dans cette étude monocentrique, nous avons suivi pendant deux ans des patients consécutifs dont le dossier médical faisait état d'une allergie à la pénicilline et chez qui un dispositif cardiaque devait être implanté. Une dose d'essai de céfazoline a été administrée aux patients sans antécédents documentés d'allergie aux céphalosporines ou de réaction anaphylactique sévère à la pénicilline. Deux doses de 100 mg de céfazoline ont été administrées par voie intraveineuse. En l'absence de réaction allergique après cinq minutes, les patients recevaient la dose complète (1 800 mg) au laboratoire d'électrophysiologie juste avant l'implantation du dispositif cardiaque. Résultats: Au total, 2 200 patients ont été inscrits à l'étude. Le taux de signalement de l'allergie à la pénicilline était de 9,3 % (n = 204). Dans 80 % des cas, le type de réaction allergique n'a pas été précisé dans les notes médicales ou était inconnu du patient. Une dose d'essai de céfazoline a été administrée à 67,6 % des patients allergiques à la pénicilline (n = 138). Au total, cinq événements indésirables se sont produits (3,6 % des patients [intervalle de confiance à 95 % : 1,1-6,1 %]) ­ quatre éruptions cutanées et un œdème de la langue. Les cinq patients touchés par ces événements sont devenus asymptomatiques après avoir reçu un antihistaminique et un corticostéroïde par voie intraveineuse. Même en l'absence de réaction allergique à la dose d'essai, 79 % des patients ont reçu de la vancomycine avant l'intervention, cet agent devant être administré par perfusion durant une heure avant la dose d'essai de céfazoline dans la salle d'intervention. Conclusion: Chez la plupart des patients allergiques à la pénicilline, une dose d'essai de céfazoline semble sans danger et permet d'avoir recours à ce médicament conformément aux lignes directrices.

DREAM-ICD-II Study.

BACKGROUND: Regulatory authorities of most industrialized countries recommend 6 months of private driving restriction after implantation of a secondary prevention implantable cardioverter-defibrillator (ICD). These driving restrictions result in significant inconvenience and social implications. This study aimed to assess the incidence rate of appropriate device therapies in contemporary recipients of a secondary prevention ICD. METHODS: This retrospective study at 3 Canadian tertiary care centers enrolled consecutive patients with new secondary prevention ICD implants between 2016 and 2020. RESULTS: For a median of 760 days (324, 1190 days), 721 patients were followed up. The risk of recurrent ventricular arrhythmia was highest during the first 3 months after device insertion (34.4%) and decreased over time (10.6% between 3 and 6 months, 11.7% between 6 and 12 months). The corresponding incidence rate per 100 patient-days was 0.48 (95% CI, 0.35-0.64) at 90 days, 0.28 (95% CI, 0.17-0.45) at 180 days, and 0.21 (95% CI, 0.13-0.33) between 181 and 365 days after ICD insertion (P<0.001). The cumulative incidence of arrhythmic syncope resulting in sudden cardiac incapacitation was 1.8% within the first 90 days and subsequently dropped to 0.4% between 91 and 180 days (P<0.001) after ICD insertion. CONCLUSIONS: The incidence rate of appropriate therapies resulting in sudden cardiac incapacitation in contemporary recipients of a secondary prevention ICD is much lower than previously reported and declines significantly after the first 3 months. Lowering driving restrictions to 3 months after the index cardiac event seems safe, and revision of existing guidelines should be considered in countries still adhering to a 6-month period. Existing restrictions for private driving after implantation of a secondary prevention ICD should be reconsidered.

Twiddler Syndrome without Lead Dislodgment Discovered by Remote Monitoring.

Twiddler syndrome is an uncommon yet dangerous phenomenon usually resulting in lead displacement with loss of capture of cardiac implantable electronic devices. In this case report, we present an interesting case of Twiddler syndrome without lead dislodgment which was detected by an alert triggered by an increase in impedance on remote monitoring.

Ventricular Arrhythmia in Septal and Apical Hypertrophic Cardiomyopathy: The French-Canadian Experience.

Background: Apical hypertrophic cardiomyopathy (aHCM) is thought to have a more benign clinical course compared to septal HCM (sHCM), but most data have been derived from Asian cohorts. Comparative data on clinical outcome in Caucasian aHCM cohorts are scarce, and the results are conflicting. The aim of this study was to estimate the prevalence and outcome of aHCM in French-Canadians of Caucasian descent. Methods and results: We conducted a retrospective, single-center cohort study. The primary endpoint was a composite of documented sustained ventricular arrhythmia (VA), appropriate ICD therapy, arrhythmogenic syncope, cardiac arrest, or all-cause mortality. A total of 301 HCM patients (65% males) were enrolled including 80/301 (27%) with aHCM and 221/301 (73%) with sHCM. Maximal wall thickness was similar in both groups. Left ventricular apical aneurysm was significantly more common in aHCM (10 vs. 0.5%; p < 0.001). The proportion of patients with myocardial fibrosis ≥ 15% of the left ventricular mass was similar between aHCM and sHCM (21 vs. 24%; p = 0.68). Secondary prevention ICDs were more often implanted in aHCM patients (16 vs. 7%; p = 0.02). The primary endpoint occurred in 26% of aHCM and 10.4% of sHCM patients (p = 0.001) and was driven by an increased incidence of sustained VA (10 vs. 2.3%; p = 0.01). Multivariate analysis identified apical aneurysm and a phenotype of aHCM as independent predictors of the primary endpoint and the occurrence of sustained ventricular tachycardia. Unexplained syncope and a family history of sudden cardiac death were additional predictors for sustained VA. Apical HCM was associated with an increased risk of ventricular arrhythmia even when excluding patients with apical aneurysm. Conclusions: The phenotype of apical HCM is much more common in French-Canadians (27%) of Caucasian descent compared to other Caucasian HCM populations. Apical HCM in French-Canadians is associated with an increased risk for ventricular arrhythmia.

Findings of remote monitoring of implantable cardioverter defibrillators during the COVID-19 pandemic.

BACKGROUND: Monitoring of cardiac implantable electronic devices was highly impacted by the COVID-19 pandemic considering the high volume of in-person visits for regular follow-up. Recent recommendations highlight the important role of remote monitoring to prevent exposure to the virus. This study compared remote monitoring of implantable cardioverter defibrillators (ICDs) in patients whose in-person annual visit was substituted for a remote monitoring session with patients who were already scheduled for a remote monitoring session. METHODS: This was a cross-sectional observational study of 329 consecutive patients between 20 March and 24 April 2020. Group 1 included 131 patients whose in-person annual visit was substituted for a remote monitoring session. Group 2 included 198 patients who underwent a remote monitoring session as scheduled in their usual device follow-up. The time interval since the last in-person visit was 13.3 ± 3.2 months in group 1 and 5.9 ± 1.7 months in group 2 (P < .01). RESULTS: In group 1, 15 patients (11.5%) experienced a clinical event compared to 15 patients (7.6%) in group 2 (P = .25). Nineteen patients (14.5%) required a physician intervention in group 1 compared to 19 patients (9.6%) in group 2 (P = .22). Two patients (1.5%) in group 1 and four patients (2.0%) in group 2 required an early in-person follow-up visit during the pandemic (P > .99). CONCLUSION: Remote monitoring of ICDs is useful to identify clinical events and allows physicians to treat patients appropriately during the COVID-19 pandemic regardless of the time interval since their last in-person visit. It reduces significantly in-person visit for regular follow-up.

Driving Restrictions and Early Arrhythmias in Patients Receiving a Primary-Prevention Implantable Cardioverter-Defibrillator (DREAM-ICD) Study.

BACKGROUND: Current guidelines recommend 4 weeks of private driving restriction after implantation of a primary-prevention implantable cardioverter-defibrillator (ICD). These driving restrictions result in significant inconvenience and social implications. Advances in medical treatment and ICD programming have lowered the overall rate of device therapies. The objective of this study was to assess the incidence of ICD therapies at 30, 60, and 180 days after implantation. METHODS: Driving Restrictions and Early Arrhythmias in Patients Receiving a Primary-Prevention Implantable Cardioverter-Defibrillator (DREAM-ICD) was a retrospective cohort study conducted at 2 Canadian university centres enrolling patients with new implantation of a primary-prevention ICD. Device programming was standardised according to current guidelines. A total of 803 patients were enrolled. RESULTS: The cumulative rates of appropriate ICD therapies at 30, 60, and 180 days were 0.12%, 0.50%, and 0.75%, respectively. There was no syncope during the first 6 months. The median duration to the first appropriate ICD therapy was 208 (range 23-1109) days after implantation. The rate of inappropriate ICD therapies at 30 days was only 0.2%. Overall, < 13.6% of all appropriate ICD therapies occurred within the first 6 months after implantation. CONCLUSIONS: The rate of appropriate ICD therapies within the first 30 days after device insertion is extremely low in contemporary primary prevention cohorts with guideline-concordant device programming. There was no increased risk for ventricular arrhythmia early after ICD insertion. The results of DREAM-ICD suggest the need for a revision of the existing driving restrictions for primary-prevention ICD recipients.

A Novel Wearable Device for Continuous Ambulatory ECG Recording: Proof of Concept and Assessment of Signal Quality.

Diagnosis of arrhythmic disorders is challenging because of their short-lasting, intermittent character. Conventional technologies of noninvasive ambulatory rhythm monitoring are limited by modest sensitivity. We present a novel form of wearable electrocardiogram (ECG) sensors providing an alternative tool for long-term rhythm monitoring with the potential of increased sensitivity to detect intermittent or subclinical arrhythmia. The objective was to assess the signal quality and R-R coverage of a wearable ECG sensor system compared to a standard 3-lead Holter. In this phase-1 trial, healthy individuals underwent 24-h simultaneous rhythm monitoring using the OMsignal system together with a 3-lead Holter recording. The OMsignal system consists of a garment (bra or shirt) with integrated sensors recording a single-lead ECG and an acquisition module for data storage and processing. Head-to-head signal quality was assessed regarding adequate P-QRS-T distinction and was performed by three electrophysiologists blinded to the recording technology. The accuracy of signal coverage was assessed using Bland-Altman analysis. Fifteen individuals underwent simultaneous 24-h recording. Signal quality and accuracy of the OMgaments was equivalent to Holter-monitoring (84% vs 93% electrophysiologists rating, p = 0.06). Signal coverage of R-R intervals showed a very close overlay between the OMsignal system and Holter signals, mean difference in heart rate of 2 5 bpm. The noise level of OMgarments was comparable to Holter recording. OMgarments provide high signal quality for adequate rhythm analysis, representing a promising novel technology for long-term non-invasive ECG monitoring.

Validation of a novel single lead ambulatory ECG monitor - Cardiostat™ - Compared to a standard ECG Holter monitoring.

BACKGROUND: Cardiostat™ is a single lead ambulatory ECG monitor. Recording is made through 2 electrodes positioned in a lead 1-like configuration. We first validated its accuracy for atrial fibrillation detection compared to a 12-lead ECG. In the second phase of the study, arrhythmia detection accuracy was compared between Cardiostat™ ambulatory ECG and a standard 24 h Holter ECG monitoring. METHOD/RESULTS: Phase one of the study included patients undergoing cardioversion for atrial fibrillation (AF) or atrial flutter. Cardiostat™ tracings were compared with standard 12-lead ECG. In the second phase, patients undergoing 24 h ambulatory Holter ECG monitoring for control or suspicion of atrial fibrillation (AF) were included. Simultaneous Holter monitoring and Cardiostat™ ECG recordings were performed. Tracings were analysed and compared. Two hundred twelve monitoring were compared. AF was diagnosed in 73 patients. Agreement between Cardiostat™ ECG and standard Holter monitoring was 99% for AF detection with kappa = 0.99. Kappa correlation for atrial flutter detection was only moderate at 0.51. AF burden was similar in both recordings. Noise hindered analysis in a greater proportion with Cardiostat™ compared to Holter ambulatory ECG (8.5 vs 3.8%). CONCLUSION: Cardiostat™ ambulatory ECG device showed excellent correlation with the standard Holter ECG monitoring for AF detection. Holter monitoring was however superior to discriminate premature atrial and ventricular beats and to qualify the morphology of PVCs since it has more vectors for analysis. Added value of Cardiostat™ includes longer monitoring duration, less cumbersome installation and water resistance.

Clinical performance of different DF-4 implantable cardioverter defibrillator leads.

INTRODUCTION: Implantable cardioverter-defibrillator (ICD) DF-4 connectors have been introduced to facilitate defibrillator lead connection and to reduce the size of device header. There are limited data regarding the overall performance of those leads and no comparison between different ICD DF-4 leads. METHODS: This is a cohort study of consecutive patients implanted with ICD DF-4 lead system at one University Centre between October 2010 and February 2015. A historical control group of patients with ICD DF-1 lead implantation was used for comparison. The following ICD DF-4 leads were evaluated: St. Jude Medical Durata 7122Q (St. Jude Medical, St. Paul, MN, USA), Medtronic Sprint Quattro Secure 6935 M (Medtronic Inc., Minneapolis, MN, USA), Boston Scientific Endotak Reliance 4-Site 0293 (Boston Scientific, Marlborough, MA, USA), and Boston Scientific Reliance 4-Front 0693. This study evaluated the acute and mid-term performances of those leads as well as complications. RESULTS: A total of 812 patients (age 63 ± 12 years, 80% male, left ventricular ejection fraction 31 ± 12%) underwent implantation of an ICD DF-4 lead. Acute and follow-up R-wave sensing and threshold were excellent. Compared to implantation, intrinsic R waves were higher at follow-up for Boston Scientific and Medtronic leads, and pacing lead impedances were lower for all leads at first follow-up (P < 0.001). The number of lead dislodgement or failure was similar between all leads. The estimated lead survival rates at 3 years were 95.6% for Boston Scientific Endotak 4-Site, 97.1% for Boston Scientific 4-Front, 97.7% for Medtronic Sprint Quattro, and 97.5% for St. Jude Durata (P  =  0.553). CONCLUSION: All ICD DF-4 leads had excellent acute and mid-term electrical performances. Longer follow-up will be necessary to confirm their sustained performance.

Cost Effectiveness of Ventricular Tachycardia Ablation Versus Escalation of Antiarrhythmic Drug Therapy: The VANISH Trial.

OBJECTIVES: This analysis uses the data from the randomized controlled trial to assess the cost effectiveness of catheter ablation (n = 132) versus escalated antiarrhythmic therapy (n = 127). BACKGROUND: For survivors of myocardial infarction with implantable cardioverter-defibrillator shocks despite antiarrhythmic drugs, the VANISH (Ventricular Tachycardia Ablation Versus Escalated Antiarrhythmic Drug Therapy in Ischemic Heart Disease) trial demonstrated improved clinical outcomes with catheter ablation compared with more aggressive antiarrhythmic pharmacotherapy. METHODS: Health care resource use and quality-of-life data were used to determine the cost effectiveness of catheter ablation. Published references were used to estimate costs (in 2015 Canadian dollars). The analysis was over 3 years, with a 5% discount rate. Adjustment was made for censoring and baseline utilities. RESULTS: Ablation resulted in greater quality-adjusted life-years (QALYs) than escalated drug therapy did (1.63 vs. 1.49; difference: 0.14; 95% confidence interval [CI]: -0.20 to 0.46) and higher cost ($65,126 vs. $60,269; difference: $4,857; 95% CI: -$19,757 to $27,106); with an incremental cost per QALY gained for ablation versus escalated drug therapy of $34,057 primarily due to the initial costs of ablation, which were partially offset by the costs of subsequent ablations and adverse outcomes in the escalated drug therapy arm. For patients with amiodarone-refractory ventricular tachycardia, ablation dominated escalated drug therapy, with greater QALYs (1.48 vs. 1.26; difference: 0.22; 95% CI: -0.19 to 0.59) and lower costs ($67,614 vs. $68,383; difference: -$769; 95% CI: -$35,330 to $27,092). For those with sotalol-refractory ventricular tachycardia, ablation resulted in similar QALYs (1.90 vs. 1.90; difference: -0.00; 95% CI: -0.59 to 0.62) and higher costs ($60,455 vs. $45,033; difference: $15,422; 95% CI: -$10,968 to $48,555). CONCLUSIONS: For the total trial population, results are suggestive that ablation is cost effective compared with escalation of drug therapy. This result was only manifest for the subgroup of patients whose qualifying arrhythmia occurred despite amiodarone.

Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic Drugs.

BACKGROUND: Recurrent ventricular tachycardia among survivors of myocardial infarction with an implantable cardioverter-defibrillator (ICD) is frequent despite antiarrhythmic drug therapy. The most effective approach to management of this problem is uncertain. METHODS: We conducted a multicenter, randomized, controlled trial involving patients with ischemic cardiomyopathy and an ICD who had ventricular tachycardia despite the use of antiarrhythmic drugs. Patients were randomly assigned to receive either catheter ablation (ablation group) with continuation of baseline antiarrhythmic medications or escalated antiarrhythmic drug therapy (escalated-therapy group). In the escalated-therapy group, amiodarone was initiated if another agent had been used previously. The dose of amiodarone was increased if it had been less than 300 mg per day or mexiletine was added if the dose was already at least 300 mg per day. The primary outcome was a composite of death, three or more documented episodes of ventricular tachycardia within 24 hours (ventricular tachycardia storm), or appropriate ICD shock. RESULTS: Of the 259 patients who were enrolled, 132 were assigned to the ablation group and 127 to the escalated-therapy group. During a mean (±SD) of 27.9±17.1 months of follow-up, the primary outcome occurred in 59.1% of patients in the ablation group and 68.5% of those in the escalated-therapy group (hazard ratio in the ablation group, 0.72; 95% confidence interval, 0.53 to 0.98; P=0.04). There was no significant between-group difference in mortality. There were two cardiac perforations and three cases of major bleeding in the ablation group and two deaths from pulmonary toxic effects and one from hepatic dysfunction in the escalated-therapy group. CONCLUSIONS: In patients with ischemic cardiomyopathy and an ICD who had ventricular tachycardia despite antiarrhythmic drug therapy, there was a significantly lower rate of the composite primary outcome of death, ventricular tachycardia storm, or appropriate ICD shock among patients undergoing catheter ablation than among those receiving an escalation in antiarrhythmic drug therapy. (Funded by the Canadian Institutes of Health Research and others; VANISH ClinicalTrials.gov number, NCT00905853.).

PA/Lateral chest X-ray is equivalent to cine-fluoroscopy for the detection of conductor externalization in defibrillation leads.

BACKGROUND: Riata™ and Riata ST defibrillation leads (St. Jude Medical, Sylmar, CA, USA) are susceptible to insulation defects with conductor externalization. Cine-fluoroscopy is considered to be the gold standard for the documentation of insulation defects, but similar detection rates have been reported for posterior-anterior (PA)/lateral chest x-ray (CXR) with zooming. OBJECTIVE: Prospective single-center study to assess the diagnostic equivalence of a PA/lateral CXR with zooming for the detection of Riata insulation defects in a direct comparison to cine-fluoroscopy. METHODS: Seventy-eight consecutive patients underwent 3-view cine-fluoroscopy and a PA/lateral CXR. All CXRs and cine-fluoroscopy images were reviewed by blinded electrophysiologists and staff radiologists. RESULTS: Forty-four of 78 patients had an abnormal cine-fluoroscopy (56%). The diagnostic correlation between PA/lateral CXR and cine-fluoroscopy was excellent (κ = 0.90; 95% confidence interval 0.80-1.00). PA/lateral CXR was equivalent to cine-fluoroscopy for the detection of conductor externalization showing a sensitivity of 97.7% and a specificity of 91.2%. The mean radiation effective dose of CXR was significantly lower compared to cine-fluoroscopy (0.09 millisievert [mSV] vs 0.85 ± 0.47 mSv; P < 0.001). Also, CXR was significantly less expensive. CONCLUSION: PA/lateral CXR with zooming is equivalent to cine-fluoroscopy for the detection of Riata insulation defects and should be considered as the preferred screening method.

Longitudinal follow-up of Riata leads reveals high annual incidence of new conductor externalization and electrical failure.

BACKGROUND AND PURPOSE: Riata(TM) defibrillation leads are susceptible to conductor externalization. The point prevalence of insulation defect in Riata(TM) leads is up to 33 %, but prospective data concerning incidence of new lead abnormalities are lacking. The purpose of our study was to determine the annual incidence of new conductor externalizations and electrical lead failure. METHODS: A prospective observational study was conducted at a single tertiary center. One hundred forty-one patients were followed over 12 months. A posterior-anterior (PA)/lateral chest x-ray (CXR) with zooming was performed at baseline and at 12 months to screen for conductor externalization. Electrical abnormalities and clinical outcome were also assessed. RESULTS: The overall incidence of new insulation defects was 8.5 % at 12 months. High-risk leads for new conductor externalization were lead models 1580, 1582, and 1590 with an annual rate of 11.9, 11.1, and 10 %, respectively. New conductor externalizations were three times more common in 8 Fr leads compared to 7 Fr leads. The overall incidence of new electrical dysfunction was 6.4 % at 12 months. Electrical dysfunction was significantly higher in abnormal leads (25 % [3/12], 4.7 % [6/129]; p = 0.03) and mostly driven by high ventricular pacing thresholds. There was no difference in inappropriate shock or failure of high-voltage therapy. CONCLUSION: The annual incidence of new insulation defects in Riata(TM) leads is much higher than previously reported. Lead models 1580, 1582, and 1590 are at highest risk for new conductor externalization. Electrical dysfunction in Riata(TM) leads is also much higher than reported and is associated with conductor externalization.

Detection of high incidence of Riata lead breaches by systematic postero-anterior and lateral chest X-ray in a large cohort.

AIMS: Insulation breaches with externalization of conductor cables have been described for St-Jude Medical Riata™ defibrillation leads. Published data on the incidence of Riata lead abnormalities are quite heterogeneous. The objective of this study was to estimate systematically the prevalence of lead abnormalities using a postero-anterior (PA) and lateral chest X-ray (CXR). METHODS AND RESULTS: From 2002 to 2008, 552 Riata defibrillation leads were implanted at our centre. We evaluated patients for potential insulation breaches. A PA and lateral CXR was obtained. Chest X-rays were reviewed by two electrophysiologists using a zooming function with magnification up to factor 7.5 and were classified as normal or abnormal for the presence of conductor externalization. A total of 284 patients were included. Riata lead models were 1570, 1580, 1582, 1590, 1592, 7000, 7002, and 7022. The total frequency of radiological lead defects was 24.3%. Insulation breaches occurred at zones of major lead curvature. Mean maximal spacing between extruding lead components was 3.6 ± 1.9 mm (range 2.0-12.4). Abnormal CXRs were more frequent in 8F leads (31.4% vs. 6.3%; P < 0.001). Most defects occurred with lead models 1582 (41.2%) and 1580 (31.4%). Mean time since implantation was longer in abnormal leads (6.7 vs. 5.9 years; P < 0.001). Abnormal leads had higher pacing thresholds (1.1 ± 0.8 V vs. 0.9 ± 0.4 V; P = 0.02). CONCLUSION: The incidence of insulation breach in Riata leads is much higher than quoted by the manufacturer or reported by most of the literature. A PA and lateral CXR with zooming appears adequate to identify lead breaches when reviewed by an electrophysiologist. Riata lead breaches without electrical abnormalities present a management dilemma and will require further studies.

Usefulness of fluorine-18 positron emission tomography/computed tomography for identification of cardiovascular implantable electronic device infections.

OBJECTIVES: This study evaluated the usefulness of fluorodesoxyglucose marked by fluorine-18 ((18)F-FDG) positron emission tomography (PET) and computed tomography (CT) in patients with suspected cardiovascular implantable electronic device (CIED) infection. BACKGROUND: CIED infection is sometimes challenging to diagnose. Because extraction is associated with significant morbidity/mortality, new imaging modalities to confirm the infection and its dissemination would be of clinical value. METHODS: Three groups were compared. In Group A, 42 patients with suspected CIED infection underwent (18)F-FDG PET/CT. Positive PET/CT was defined as abnormal uptake along cardiac devices. Group B included 12 patients without infection who underwent PET/CT 4 to 8 weeks post-implant. Group C included 12 patients implanted for >6 months without infection who underwent PET/CT for another indication. Semi-quantitative ratio (SQR) was obtained from the ratio between maximal uptake and lung parenchyma uptake. RESULTS: In Group A, 32 of 42 patients with suspected CIED infection had positive PET/CT. Twenty-four patients with positive PET/CT underwent extraction with excellent correlation. In 7 patients with positive PET/CT, 6 were treated as superficial infection with clinical resolution. One patient with positive PET/CT but negative leukocyte scan was considered false positive due to Dacron pouch. Ten patients with negative-PET/CT were treated with antibiotics and none has relapsed at 12.9 ± 1.9 months. In Group B, patients had mild uptake seen at the level of the connector. There was no abnormal uptake in Group C patients. Median SQR was significantly higher in Group A (A = 2.02 vs. B = 1.08 vs. C = 0.57; p < 0.001). CONCLUSIONS: PET/CT is useful in differentiating between CIED infection and recent post-implant changes. It may guide appropriate therapy.

Recommendations for the use of genetic testing in the clinical evaluation of inherited cardiac arrhythmias associated with sudden cardiac death: Canadian Cardiovascular Society/Canadian Heart Rhythm Society joint position paper.

The era of gene discovery and molecular medicine has had a significant impact on clinical practice. Knowledge of specific genetic findings causative for or associated with human disease may enhance diagnostic accuracy and influence treatment decisions. In cardiovascular disease, gene discovery for inherited arrhythmia syndromes has advanced most rapidly. The arrhythmia specialist is often confronted with the challenge of diagnosing and managing genetic arrhythmia syndromes. There is now a clear need for guidelines on the appropriate use of genetic testing for the most common genetic conditions associated with a risk of sudden cardiac death. This document represents the first ever published recommendations outlining the role of genetic testing in various clinical scenarios, the specific genes to be considered for testing, and the utility of test results in the management of patients and their families.

Prospective comparison between conventional transseptal puncture and transseptal needle puncture with radiofrequency energy.

PURPOSE: Patients undergoing left atrial ablation require transseptal puncture, which can be challenging, even for experienced physicians. This study compared the efficacy and safety of radiofrequency (RF) energy transseptal punctures to conventional approach. METHODS: Patients requiring transseptal puncture for left atrial access were included using either conventional approach or the NRG™ RF transseptal needle as first attempt. Procedure time for transseptal access, fluoroscopy time, crossover, and safety of both techniques were compared. RESULTS: A total of 241 transseptal punctures were performed in 148 consecutive patients (114 men, 54 ± 10 years, left atrial volume 32 ± 10 ml/m(2)) who underwent 157 procedures with left atrial access, mainly for atrial fibrillation. It was a repeat transseptal procedure in 49 patients. Procedures were guided by transesophageal echocardiography. RF transseptal puncture was planned in 119 procedures. RF was delivered in 98 procedures (82%) for 139/187 punctures: 48 punctures did not require RF, including 25 punctures performed by exposing the needle tip, 22 through patent foramen ovale, and 1 RF delivery failure by the generator. Average time for RF transseptal was 4.8 ± 2.8 min compared to 7.5 ± 8.5 min for conventional approach (p = 0.045). Fluoroscopy time was 1.8 ± 1.3 min for RF transseptal and 2.9 ± 2.8 min for standard approach (p = 0.043). Four patients required crossover to RF transseptal needle in the conventional group (p = 0.003). One tamponade occurred at the end of procedure in a patient using the RF needle, and one interatrial septum dissection with aortic root hematoma occurred in the conventional group. CONCLUSIONS: Transseptal needle puncture using RF energy can be performed safely and quickly under imaging guidance.

Contractile reserve assessed using dobutamine echocardiography predicts left ventricular reverse remodeling after cardiac resynchronization therapy: prospective validation in patients with left ventricular dyssynchrony.

BACKGROUND: The presence of viable myocardium may predict response to cardiac resynchronization therapy (CRT). The aim of this study is to evaluate in patients with left ventricular (LV) dyssynchrony whether response to CRT is related to myocardial viability in the region of the pacing lead. METHODS: Forty-nine consecutive patients with advanced heart failure, LV ejection fraction < 35%, QRS duration > 120 ms and intraventricular asynchronism > or = 50 ms were included. Dobutamine stress echocardiography was performed within the week before CRT implantation. Resting echocardiography was performed 6 months after CRT implantation. Viability in the region of LV pacing lead was defined as the presence of viability in two contiguous segments. Response to CRT was defined by evidence of reverse LV remodeling (> or =15% reduction in LV end-systolic volume). RESULTS: Thirty-one patients (63%) were identified as responders at follow-up. The average of viable segments was 5.9 +/- 2 in responders and 3.2 +/- 3 in nonresponders (P = 0.0003). Viability in the region of the pacing lead had a sensitivity of 94%, a specificity of 67%, a positive predictive value of 83%, and a negative predictive value of 86% for the prediction of response to CRT. CONCLUSIONS: In patients with LV dyssynchrony, reverse remodeling after CRT requires viability in the region of the pacing lead. This simple method using echocardiography dobutamine for the evaluation of local viability (i.e., viability in two contiguous segments) may be useful to the clinician in choosing the best LV lead positioning.