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

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Clinical performance of implantable cardioverter-defibrillator lead monitoring diagnostics

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No long-term psychological morbidity living with an implantable cardioverter defibrillator under advisory: the Medtronic Marquis experience

Aims: It is unclear whether there is important psychological morbidityassociated with living with an implantable cardioverter defibrillator(ICD) under advisory and whether this should be factored intodecision-making. Methods and results: Our study focused on patients living with advisory MedtronicMarquis ICDs. Patient adjustment to the ICD was evaluated usinga validated device-specific metric of patient acceptance, theFlorida Patient Acceptance Survey (FPAS). A comparison groupof patients with other models of ICDs that were not under anadvisory also completed the study measure. The questionnairereturn rate was 86/122 (70.5%) in the advisory group and 94/134(70.1%) in the non-advisory group. Only one patient in our clinicelected for generator change due to severe anxiety. There wereno differences in demographic or clinical variables betweenthe groups. There were no differences in the mean total FPASscore between the two patient groups (advisory patients 85.97± 14.95 and 86.23 ± 15.76 for non-advisory, P=0.340).Also there were no differences in any of the subscores. Correlatesof poor device acceptance were younger age and a history ofelectrical storm. Conclusion: We found no evidence of increased long-term psychological morbidityin patients living with an ICD under advisory compared withpatients with an ICD not under advisory. Our data suggest thatpatients and physicians should avoid hasty decisions about ICDreplacement for psychological reasons.     

Rates and severity of perforation from implantable cardioverter-defibrillator leads: A 4-year study

INTRODUCTION: Although recent case reports and one small single-year observational study report a substantially increased rate of perforation with the St. Jude Riata series defibrillator lead, these results have not been externally validated. METHODS AND RESULTS: From 2004 to 2007, 593 implantable cardioverter-defibrillator (ICD) implants were performed by six faculty and 13 fellows at four University of California, San Francisco, CA, USA and affiliate hospitals. An electronic medical records system was systematically searched to identify clinically significant cases of ICD lead dislodgment or perforation. Of 307 (56%) St. Jude leads (all Riata series 6.3- and 7.3-French leads), 188 (29%) Medtronic leads (including 99 Sprint Fidelis 6.6 French leads), and 98 (15%) Guidant/Boston Scientific leads, there were three perforations in 593 cases (0.51%). One perforation occurred with a Medtronic Sprint Fidelis 6949 lead (0.53%), and two with a St. Jude Riata 1581 lead (0.65%). There were no statistically significant differences in perforation or dislodgement rates between manufacturers or lead models (p = NS for all). In both cases of perforation with the St. Jude Riata leads, the lead tip perforated through the pericardium into the pleural space. CONCLUSIONS: In our 4-year series of ICD implants, perforation and dislodgement rates were low, similar across all lead makes and models, and well below published and accepted complication rates. Our findings contradict previously-reported higher rates of perforation with the Riata lead. Registry and product performance reports should also classify complications by severity and outcome to provide a more complete assessment of product safety.     

Predictors of perforation during lead extraction: Results of the Canadian Lead ExtrAction Risk (CLEAR) study

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Canadian Cardiovascular Society/Canadian Heart Rhythm Society Joint Position Statement on the Use of Remote Monitoring for Cardiovascular Implantable Electronic Device Follow-up

Remote monitoring (RM) is a form of telemedicine technology that permits implanted pacemakers and implantable cardioverter-defibrillators to transmit diagnostic information for review by health care professionals without patients needing to visit the device follow-up clinic. A bedside transmitter in the patient's home conveys the device data using standard telecommunication protocol to a protected internet-accessible RM data server, which authorized health care professionals can access at any time using standard web browser software. Evidence indicates it can accelerate identification of clinical events and potential device problems. RM raises important medicolegal issues concerning the protection of a patient's rights and the safeguarding of patient health information related to the collection, storage, and use of patient device information that must be addressed by follow-up centres. This position statement recommends that remote monitoring be available at all device follow-up clinics as an integral part of the standard of care of device patients and also provides helpful advice to centres for the proper design, implementation, and integration of a remote monitoring system into the clinic.     

Canadian Cardiovascular Society/Canadian Heart Rhythm Society Joint Position Statement on the Cardiovascular Screening of Competitive Athletes

Sudden cardiac death (SCD), especially in a young seemingly healthy individual, is a tragic and highly publicized event, which is often followed by a strong emotional reaction from the public and medical community.” Although rare, SCD in the young is devastating to families and communities, underpinning our society’s desire to avoid any circumstances predisposing to the loss of human life during exertion. The Canadian Cardiovascular Society Position Statement on the cardiovascular screening of athletes provides evidence-based recommendations for Canadian sporting organizations and institutions with a focus on the role of routine electrocardiogram (ECG) screening in preventing SCD. We recommend that the cardiac screening and care of athletes within the Canadian health care model comprise a sequential (tiered) approach to the identification of cardiac risk, emphasizing the limitations of screening, the importance of shared decision-making when cardiac conditions are diagnosed, and the creation of policies and procedures for the management of emergencies in sport settings. Thus, we recommend against the routine (first-line or blanket mass performance of ECG) performance of a 12-lead ECG for the initial cardiovascular screening of competitive athletes. Organization/athlete-centred cardiovascular screening and care of athletes program is recommended. Such screening should occur in the context of a consistent, systematic approach to cardiovascular screening and care that provides: assessment, appropriate investigations, interpretation, management, counselling, and follow-up. The recommendations presented comprise a tiered framework that allows institutions some choice as to program creation.     

Brugada syndrome: report of the second consensus conference: endorsed by the Heart Rhythm Society and the European Heart Rhythm Association

Since its introduction as a clinical entity in 1992, the Brugada syndrome has progressed from being a rare disease to one that is second only to automobile accidents as a cause of death among young adults in some countries. Electrocardiographically characterized by a distinct ST-segment elevation in the right precordial leads, the syndrome is associated with a high risk for sudden cardiac death in young and otherwise healthy adults, and less frequently in infants and children. Patients with a spontaneously appearing Brugada ECG have a high risk for sudden arrhythmic death secondary to ventricular tachycardia/fibrillation. The ECG manifestations of Brugada syndrome are often dynamic or concealed and may be unmasked or modulated by sodium channel blockers, a febrile state, vagotonic agents, alpha-adrenergic agonists, beta-adrenergic blockers, tricyclic or tetracyclic antidepressants, a combination of glucose and insulin, hypo- and hyperkalemia, hypercalcemia, and alcohol and cocaine toxicity. In recent years, an exponential rise in the number of reported cases and a striking proliferation of articles defining the clinical, genetic, cellular, ionic, and molecular aspects of the disease have occurred. The report of the first consensus conference, published in 2002, focused on diagnostic criteria. The present report, which emanated from the second consensus conference held in September 2003, elaborates further on the diagnostic criteria and examines risk stratification schemes and device and pharmacological approaches to therapy on the basis of the available clinical and basic science data.