Canadian Heart Rhythm Society Research Articles

Navigating the Landscape of Medical Device Advisories: A Special Report From the Canadian Heart Rhythm Society Device Advisory Committee

Cardiac implantable electronic devices (CIEDs) are often important for regulating cardiac rate and rhythm. Pacemakers and defibrillators are among the top 10 most implanted medical devices, with > 1.5 million devices implanted annually. Although millions of patients have benefited with improved quality of life and survival, CIED systems are becoming increasingly complex and do not always perform according to expectations. Advisory notices communicate important information about the safety and performance of a medical device to health care providers and patients. Medical device recalls are common, with > 35 unique device recalls in the past 5 years. From an ethical standpoint, CIED recalls highlight a range of considerations including the consent process, duty to report, how best to promote autonomous decision-making, trust in the health care system, as well as disproportionate effects of these considerations on equity-deserving groups. The purpose of the current article is to review and advise regarding the process around medical device advisory and recall, with a specific focus on clinicians caring for patients affected by these devices. We have sought the input of a lawyer, a patient advocacy group, and an ethicist to guide the clinical management of, and communications regarding, device recalls and advisories. Diligent surveillance and a clear, transparent patient consent process regarding these small but potentially serious device anomalies is paramount in ensuring patients believe they are safe and informed. Meaningful patient engagement helps to ensure optimal communication and disclosure mechanisms before implantation and throughout follow-up, accessibility of information in the initial implant and recall action process, and trust in health care systems and providers.

EHRA clinical consensus statement on conduction system pacing implantation: executive summary. Endorsed by the Asia-Pacific Heart Rhythm Society (APHRS), Canadian Heart Rhythm Society (CHRS) and Latin-American Heart Rhythm Society (LAHRS).

Conduction system pacing (CSP) has emerged as a more physiological alternative to right ventricular pacing and is also being used in selected cases for cardiac resynchronization therapy. His bundle pacing was first introduced over two decades ago and its use has risen over the last years with the advent of tools which have facilitated implantation. Left bundle branch area pacing is more recent but its adoption is growing fast due to a wider target area and excellent electrical parameters. Nevertheless, as with any intervention, proper technique is a prerequisite for safe and effective delivery of therapy. This document aims to standardize the procedure and to provide a framework for physicians who wish to start CSP implantation, or who wish to improve their technique. A synopsis is provided in this print edition of EP-Europace. The full document may be consulted online, and a 'Key Messages' App can be downloaded from the EHRA website.

EHRA clinical consensus statement on conduction system pacing implantation: endorsed by the Asia Pacific Heart Rhythm Society (APHRS), Canadian Heart Rhythm Society (CHRS), and Latin American Heart Rhythm Society (LAHRS).

Conduction system pacing (CSP) has emerged as a more physiological alternative to right ventricular pacing and is also being used in selected cases for cardiac resynchronization therapy. His bundle pacing was first introduced over two decades ago and its use has risen over the last five years with the advent of tools which have facilitated implantation. Left bundle branch area pacing is more recent but its adoption is growing fast due to a wider target area and excellent electrical parameters. Nevertheless, as with any intervention, proper technique is a prerequisite for safe and effective delivery of therapy. This document aims to standardize the procedure and to provide a framework for physicians who wish to start CSP implantation, or who wish to improve their technique.

Approach to atrial fibrillation: Essentials for primary care.

To support family physicians in preventing atrial fibrillation (AF) in patients at risk and in identifying and managing those with established AF; and to summarize key recommendations for ideal screening and care of patients. The 2020 Canadian Cardiovascular Society and Canadian Heart Rhythm Society comprehensive guidelines for the management of AF, based on current evidence and clinical experience related to AF. Atrial fibrillation, which is estimated to affect at least 500,000 Canadians, is associated with high risks of stroke, heart failure, and death. Primary care clinicians occupy a central role in the management of this chronic condition, focusing on the challenges of preventing AF and identifying, diagnosing, treating, and following patients with AF. Evidence-based guidelines that provide optimal management strategies have been published by the Canadian Cardiovascular Society and Canadian Heart Rhythm Society to assist in these tasks. Messages critical to primary care are offered to support effective knowledge translation. Most patients with AF can be managed effectively in primary care. Family physicians not only play an important role in ensuring patients with AF receive timely diagnoses, but they are also key to providing initial and ongoing care, especially in patients with comorbid conditions.

Canadian Heart Rhythm Society Task Force Report on Physician Training and Maintenance of Competency for Cardiovascular Implantable Electronic Device Therapies: Executive Summary

Physicians engaged in cardiovascular implantable electronic device (CIED)–related practice come from diverse training backgrounds with variable degrees of CIED implant training. The objective of the Canadian Heart Rhythm Society Task Force on CIED Implant Training was to establish a common structure and content for training programs in CIED implantation, related activities and maintenance of competency. This executive summary presents the essence of the report with key recommendations included, with the complete version made available in a linked supplement. The goals are to ensure that future generations of CIED implanters are better prepared for continuously evolving CIED practice and quality care for all Canadians.

Guidance on Minimizing Risk of Drug-Induced Ventricular Arrhythmia During Treatment of COVID-19: A Statement from the Canadian Heart Rhythm Society

The COVID-19 pandemic has led to efforts at rapid investigation and application of drugs which may improve prognosis but for which safety and efficacy are not yet established. This document attempts to provide reasonable guidance for the use of antimicrobials which have uncertain benefit but may increase risk of QT interval prolongation and ventricular proarrhythmia, notably, chloroquine, hydroxychloroquine, azithromycin, and lopinavir/ritonavir. During the pandemic, efforts to reduce spread and minimize effects on health care resources mandate minimization of unnecessary medical procedures and testing. We recommend that the risk of drug proarrhythmia be minimized by 1) discontinuing unnecessary medications that may also increase the QT interval, 2) identifying outpatients who are likely to be at low risk and do not need further testing (no history of prolonged QT interval, unexplained syncope, or family history of premature sudden cardiac death, no medications that may prolong the QT interval, and/or a previous known normal corrected QT interval [QTc]), and 3) performing baseline testing in hospitalized patients or those who may be at higher risk. If baseline electrocardiographic testing reveals a moderately prolonged QTc, optimization of medications and electrolytes may permit therapy. If the QTc is markedly prolonged, drugs that further prolong it should be avoided, or expert consultation may permit administration with mitigating precautions. These recommendations are made while there are no known effective treatments for COVID-19 and should be revisited when further data on efficacy and safety become available.

Shared Decision Making and the Cardiovascular Care of Athletes: Is It Time to Get Back in the Game?

Prevention of sudden cardiac arrest/death and disease progression has traditionally been the primary basis for determining exercise recommendations for those with underlying cardiovascular disease. Potential harms of exercise restriction, including physical inactivity’s impact on obesity, chronic disease, and negative psychological and emotional consequences, have been considered ancillary, if considered at all. Accumulating evidence suggests the relative safety of continued sport and exercise participation in the vast majority of those with a variety of cardiac conditions that were previously considered to be criteria for exclusion. Despite ongoing clinical uncertainty however, respect for patient autonomy and the inclusion of patient values and preferences is now required in the decision-making process. The shared decision-making construct, a cornerstone of patient-centred care, should be applied for determining exercise and participation recommendations for those with cardiovascular disease. Safe exercise principles should be employed in all cases, regardless of whether athletes chose to follow recommendations, following a harm-reduction model. This approach is recommended by the 2019 Canadian Cardiovascular Society and Canadian Heart Rhythm Society Joint Position Statement on the Cardiovascular Screening of Competitive Athletes, and other contemporary societal guidelines, for all aspects of cardiovascular care of athletes.

Translation of the Canadian Cardiovascular Society/Canadian Heart Rhythm Society Cardiovascular Screening and Care of Athletes Program Into Practice

In the absence of systematic cardiovascular preparticipation screening (PPS) practices in Canada, the Canadian Cardiovascular Society and Canadian Heart Rhythm Society published a joint position statement outlining PPS recommendations for competitive athletes in an effort to standardize screening. The Queen’s University Cardiovascular Screening and Care of Athletes Program aimed to translate these recommendations into practice. Screening packages were administered to athletes in 2017 and 2018. Each package required completion of a medical/history questionnaire, a physician’s examination, and 12-lead electrocardiogram performed by the athlete’s primary care physician. A tiered approach to screening, as recommended by the position statement, was implemented. A multidisciplinary team flagged at-risk athletes and determined the need for follow-up testing and participation eligibility. Over a 2-year period, 517 varsity athletes were screened, with 438 (84.7%) completing all recommended screening components. Analysis of completed packages resulted in 114 (26.0%) athletes flagged for initial review. After subsequent review by an emergency care physician, only 12 (2.7%) athletes required further referral to cardiology for assessment or further testing. All athletes referred for cardiology assessment were cleared for participation, except for one, who was eventually cleared after a shared decision-making process and cardiovascular intervention. The Queen’s University Cardiovascular Screening and Care of Athletes Program shows the successful implementation of a cardiovascular PPS program that used shared decision-making and a multidisciplinary approach to screening, allowing for efficiency and effective resource utilization.

2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation.

2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation.

2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation: executive summary

2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation: executive summary

WITHDRAWN: 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation

WITHDRAWN: 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation

Catheter ablation for atrial flutter: a survey by the European Heart Rhythm Association and Canadian Heart Rhythm Society.

Catheter ablation for atrial flutter: a survey by the European Heart Rhythm Association and Canadian Heart Rhythm Society.

Retracted. Catheter ablation for atrial flutter: a survey by the European Heart Rhythm Association and Canadian Heart Rhythm Society.

The purpose of this EP wire survey was to examine current practice in the management of both cavotricuspid isthmus (CTI)-dependent and non-CTI-dependent atrial flutter (AFL) ablation amongst electrophysiologists in European and Canadian centres and to understand how current opinions vary from guidelines. The results of the survey were collected from a detailed questionnaire that was created by the European Heart Rhythm Association Research Network and the Canadian Heart Rhythm Society. Responses were received from 89 centres in 12 countries. The survey highlighted variability within certain aspects of the management of AFL ablation. The variability in opinion regarding other procedural details suggests a need for further research in this area and consideration of the development of guidelines specific to AFL. Overall, there is reasonable consensus regarding oral anticoagulation and the desired endpoints of ablation for patients with CTI-dependent AFL and for non-CTI-dependent AFL.

Catheter ablation for atrial flutter: a survey by the European Heart Rhythm Association and Canadian Heart Rhythm Society.

The purpose of this EP wire survey was to examine current practice in the management of both cavotricuspid isthmus (CTI)-dependent and non-CTI-dependent atrial flutter (AFL) ablation amongst electrophysiologists in European and Canadian centres and to understand how current opinions vary from guidelines. The results of the survey were collected from a detailed questionnaire that was created by the European Heart Rhythm Association Research Network and the Canadian Heart Rhythm Society. Responses were received from 89 centres in 12 countries. The survey highlighted variability within certain aspects of the management of AFL ablation. The variability in opinion regarding other procedural details suggests a need for further research in this area and consideration of the development of guidelines specific to AFL. Overall, there is reasonable consensus regarding oral anticoagulation and the desired endpoints of ablation for patients with CTI-dependent AFL and for non-CTI-dependent AFL.

Canadian Heart Rhythm Society and Canadian Association of Radiologists Consensus Statement on Magnetic Resonance Imaging With Cardiac Implantable Electronic Devices

Magnetic resonance imaging (MRI) has historically been considered contraindicated for individuals with cardiac implantable electronic devices (CIEDs) such as pacemakers and implantable defibrillators. Magnetic resonance scanners produce magnetic fields that can interact negatively with the metallic components of CIEDs. However, as CIED technology has advanced, newer MRI conditional devices have been developed that are now in clinical use and these systems have had demonstrated safety in the MRI environment. Despite the supportive data of such CIED systems, physicians remain reluctant to perform MRI scanning of conditional devices. This joint statement by the Canadian Heart Rhythm Society and the Canadian Association of Radiologists describes a collaborative process by which CIED specialists and clinics can work with radiology departments and specialists to safely perform MRI in patients with MRI conditional CIED systems. The steps required for patient and scanning preparation and the roles and responsibilities of the CIED and radiology departments are outlined. We also briefly outline the risks and a process by which patients with nonconditional CIEDs might also receive MRI in highly specialized centres. This document supports MRI in patients with MRI conditional CIEDs and offers recommendations on how this can be implemented safely and effectively.

PACES/HRS Expert Consensus Statement on the Recognition and Management of Arrhythmias in Adult Congenital Heart Disease: Executive Summary

Recognition and Management of Arrhythmias in Adult Congenital Heart Disease: Executive Summary Developed in partnership between the Pediatric and Congenital Electrophysiology Society (PACES) and the Heart Rhythm Society (HRS). Endorsed by the governing bodies of PACES, HRS, the American College of Cardiology (ACC), the American Heart Association (AHA), the European Heart Rhythm Association (EHRA), the Canadian Heart Rhythm Society (CHRS), and the International Society for Adult Congenital Heart Disease (ISACHD)

Canadian Heart Rhythm Society and Canadian Association of Radiologists Consensus Statement on Magnetic Resonance Imaging With Cardiac Implantable Electronic Devices

Magnetic resonance imaging (MRI) has historically been considered contraindicated for individuals with cardiac implantable electronic devices (CIEDs) such as pacemakers and implantable defibrillators. Magnetic resonance scanners produce magnetic fields that can interact negatively with the metallic components of CIEDs. However, as CIED technology has advanced, newer MRI conditional devices have been developed that are now in clinical use and these systems have had demonstrated safety in the MRI environment. Despite the supportive data of such CIED systems, physicians remain reluctant to perform MRI scanning of conditional devices. This joint statement by the Canadian Heart Rhythm Society and the Canadian Association of Radiologists describes a collaborative process by which CIED specialists and clinics can work with radiology departments and specialists to safely perform MRI in patients with MRI conditional CIED systems. The steps required for patient and scanning preparation and the roles and responsibilities of the CIED and radiology departments are outlined. We also briefly outline the risks and a process by which patients with nonconditional CIEDs might also receive MRI in highly specialized centres. This document supports MRI in patients with MRI conditional CIEDs and offers recommendations on how this can be implemented safely and effectively.

The Canadian experience with Durata and Riata ST Optim defibrillator leads: A report from the Canadian Heart Rhythm Society Device Committee

The St. Jude Medical Riata family of implantable cardioverter-defibrillator (ICD) leads has demonstrated a high rate of externalized conductors and electrical failure. Given similar design elements of Durata to Riata, the purpose of this study was to assess the rates of failure of the Riata ST Optim and Durata lead families in Canada. All Canadian ICD-implanting centers were invited to submit follow-up information on all Optim-coated ICD leads implanted. Electrical failure was defined as a rapid change in impedance or pacing capture threshold leading to lead revision, or oversensing due to noise. Externalized conductors were defined as appearance of conductor wires outside the lead body. Systematic fluoroscopic screening for externalized conductors was not performed. As of December 1, 2012, 15 of 25 centers provided data on 3981 leads (44% of those sold in Canada during the same timeframe): 3477 Durata and 504 Riata ST Optim leads. The most common model numbers were 7122 (1516 leads [38%]), 7121 (707 leads [18%]), and 7120 (622 leads [16%]). Mean follow-up duration from implant to December 1, 2012, was 4.47 ± 0.48 years for Riata ST Optim leads and 2.00 ± 1.10 years for Durata leads. The annual rate of lead failure was 0.27% per year for Riata ST Optim leads and 0.24% per year for Durata leads. No instances of externalized conductors were identified in the failed leads. No deaths were attributed to lead failure; however, 2 patients experienced inappropriate shocks due to lead failure. The overall electrical failure rates of the Riata ST Optim and Durata leads appear to be low, and no instances of externalized conductors were observed.

PACES/HRS Expert Consensus Statement on the Management of the Asymptomatic Young Patient with a Wolff-Parkinson-White (WPW, Ventricular Preexcitation) Electrocardiographic Pattern

C PACES/HRS Expert Consensus Statement on the Management of the Asymptomatic Young Patient with a Wolff-Parkinson-White (WPW, Ventricular Preexcitation) Electrocardiographic Pattern Developed in partnership between the Pediatric and Congenital Electrophysiology Society (PACES) and the Heart Rhythm Society (HRS). Endorsed by the governing bodies of PACES, HRS, the American College of Cardiology Foundation (ACCF), the American Heart Association (AHA), the American Academy of Pediatrics (AAP), and the Canadian Heart Rhythm Society (CHRS)

Nonphysiologic noise early after defibrillator implantation in Canada: Incidence and implications

Following recent cases of nonphysiologic noise noted early after defibrillator implantation, the Canadian Heart Rhythm Society Device Committee decided to evaluate the implications of this problem. To determine the incidence and consequences of nonphysiologic noise early after defibrillator implantation. The Canadian Heart Rhythm Society Device Committee surveyed all Canadian defibrillator implanting centers regarding their implant volumes and number of cases where nonphysiologic noise had been noted early (< 24 hours) after implant over the preceding 2 years. For such cases, information regarding the manufacturer and occurrence of inappropriate shock or inhibition of pacing was reported. Responses were obtained from 20 of 23 surveyed implanting centers, with a total implant volume of 4960 defibrillators per year. The occurrence of nonphysiologic noise early after implantation was noted in 25 cases over the preceding 2 years (0.25%). Noise was detected in devices of all 3 of the leading volume device manufacturers. There were 2 cases of inappropriate shocks and 2 cases of symptomatic pacing inhibition. In 4 cases, removal of the lead from the header and retesting with the analyzer confirmed normal lead function. In all cases, the noise resolved within 24 hours. Nonphysiologic noise early after defibrillator implantation was noted in 0.25% of procedures and was not limited to one specific manufacturer. This noise may result in an inappropriate shock or inhibition of pacing in a pacemaker-dependent patient. This transient phenomenon, possibly related to fluid and/or air in the header, appears to always resolve without surgical intervention.