Alaa Shalaby

The National ICD Registry Report: Version 2.1 including leads and pediatrics for years 2010 and 2011

Mark S. Kremers, MD, FHRS, Stephen C. Hammill, MD, FHRS, Charles I. Berul, MD, FHRS, Christina Koutras, RN, Jeptha S. Curtis, MD, Yongfei Wang, MS, Jim Beachy, RCIS, Laura Blum Meisnere, MA, Del M. Conyers, MPH, Matthew R. Reynolds, MD, Paul A. Heidenreich, MD, Sana M. Al-Khatib, MD, MHS, FHRS, Ileana L. Pina, MD, MPH, Kathleen Blake, MD, MPH, FHRS, Mary Norine Walsh, MD, Bruce L. Wilkoff, MD, FHRS, Alaa Shalaby, MD, FHRS, Frederick A. Masoudi, MD, MSPH, John Rumsfeld, MD, PhD

Appropriateness of primary prevention implantable cardioverter- defibrillators at the time of generator replacement: Are indications still met?

OBJECTIVES This study sought to determine how often patients with primary prevention implantable cardioverter-defibrillators (ICDs) meet guideline-derived indications at the time of generator replacement. BACKGROUND Professional societies have developed guideline criteria for the appropriate implantation of an ICD for the primary prevention of sudden cardiac death. It is unknown whether patients continue to meet criteria when their devices need replacement for battery depletion. METHODS We performed a retrospective chart review of patients undergoing replacement of primary prevention ICDs at 2 tertiary Veterans Affairs Medical Centers. Indications for continued ICD therapy at the time of generator replacement included a left ventricular ejection fraction (LVEF) ≤35% or receipt of appropriate device therapy. RESULTS In our cohort of 231 patients, 59 (26%) no longer met guideline-driven indications for an ICD at the time of generator replacement. An additional 79 patients (34%) had not received any appropriate ICD therapies and had not undergone reassessment of their LVEF. Patients with an initial LVEF of 30% to 35% were less likely to meet indications for ICD therapy at the time of replacement (odds ratio: 0.52; 95% confidence interval: 0.30 to 0.88; p = 0.01). Patients without ICD indications subsequently received appropriate ICD therapies at a significantly lower rate than patients with indications (2.8% vs. 10.7% annually, p < 0.001). If ICD generator explantations were performed instead of replacements in the patients without ICD indications, the cost savings would be

Genetic variation in the alternative splicing regulator RBM20 is associated with dilated cardiomyopathy

1.6 million. CONCLUSIONS Approximately 25% of patients who receive primary prevention ICDs may no longer meet guideline indications for ICD use at the time of generator replacement, and these patients receive subsequent ICD therapies at a significantly lower rate.

Usefulness of Pulmonary Artery Pressure by Echocardiography to Predict Outcome in Patients Receiving Cardiac Resynchronization Therapy Heart Failure

BACKGROUND Dilated cardiomyopathy (DCM) is a leading cause of heart failure and death. The etiology of DCM is genetically heterogeneous. OBJECTIVES We sought to define the prevalence of mutations in the RNA splicing protein RBM20 in a large cohort with DCM and to determine whether genetic variation in RBM20 is associated with clinical outcomes. METHODS Subjects included in the Genetic Risk Assessment of Defibrillator Events (GRADE) study were aged at least 18 years, had an ejection fraction of ≤30%, and an implantable cardioverter-defibrillator (ICD). The coding region and splice junctions of RBM20 were screened in subjects with DCM; 2 common polymorphisms in RBM20, rs942077 and rs35141404, were genotyped in all GRADE subjects. RESULTS A total of 1465 subjects were enrolled in the GRADE study, and 283 with DCM were screened for RBM20 mutations. The mean age of subjects with DCM was 58 ± 13 years, 64% were males, and the mean follow-up time was 24.2 ± 17.1 months after ICD placement. RBM20 mutations were identified in 8 subjects with DCM (2.8%). Mutation carriers had a similar survival, transplantation rate, and frequency of ICD therapy compared with nonmutation carriers. Three of 8 subjects with RBM20 mutations (37.5%) had atrial fibrillation (AF), whereas 19 subjects without mutations (7.4%) had AF (P = .02). Among all GRADE subjects, rs35141404 was associated with AF (minor allele odds ratio = 0.62; 95% confidence interval = 0.44-0.86; P = .006). In the subset of GRADE subjects with DCM, rs35141404 was associated with AF (minor allele odds ratio = 0.58; P = .047). CONCLUSIONS Mutations in RBM20 were observed in approximately 3% of subjects with DCM. There were no differences in survival, transplantation rate, and frequency of ICD therapy in mutation carriers.

Fluoroscopic Screening of Asymptomatic Patients Implanted With the Recalled Riata Lead Family

Secondary pulmonary hypertension is a marker of advanced heart failure (HF) that confers a poor prognosis. Consecutive patients from 2004 through 2005 who underwent echocardiographic assessments of systolic pulmonary arterial pressure (SPAP) before the implantation of cardiac resynchronization therapy defibrillators were included. Patients were divided into tertiles according to baseline SPAP. Patients in the lowest (group I, 20 to 29 mm Hg) and highest (group III, 45 to 88 mm Hg) tertiles were compared for the end points or death or transplantation and for HF hospital admission. Two hundred seventy patients were evaluated, of whom 95% were Caucasians and 91% men. The mean age was 66.5 +/- 11.6 years, the mean QRS duration was 155 +/- 30 ms, the mean left ventricular ejection fraction was 22.6 +/- 9.7%, and the mean New York Heart Association functional class was 3.0 +/- 0.4. In a multivariate model, death or transplantation was significantly more likely in group III (hazard ratio 2.62, 95% confidence interval 1.1 to 6.4, p = 0.036), as was HF admission (hazard ratio 6.35, 95% confidence interval 2.6 to 15.8, p <0.001). In patients with follow-up echocardiographic assessments, a reduction in SPAP was a significant predictor of freedom from the combined end point (hazard ratio 0.29, 95% confidence interval 0.12 to 0.76, p = 0.011). In conclusion, elevated baseline SPAP in patients who underwent cardiac resynchronization therapy is an independent predictor of all-cause mortality or transplantation and HF admission. A decrease in SPAP on follow-up echocardiography is an independent positive prognostic marker.

Late Perforation by Cardiac Implantable Electronic Device Leads: Clinical Presentation, Diagnostic Clues, and Management

Background— The Food and Drug Administration recently issued a class I recall of the St. Jude Medical Riata implantable cardioverter-defibrillator lead presumably because of increased risk of electric failure and mechanical separation via inside-out abrasion. We sought to examine the incidence and time dependence of inside-out abrasion in asymptomatic patients implanted with the Riata lead. Methods and Results— Asymptomatic patients implanted with the Riata lead at our institution were offered voluntary fluoroscopic screening in 3 views. Electric testing of the Riata lead with provocative isometric muscle contraction was performed at the time of fluoroscopic screening. Of the 245 patients undergoing fluoroscopic screening, 53 (21.6%) patients showed clear evidence of lead separation. Of these externalized leads, 0%, 13%, and 26% had a dwell time of <3 years, 3 to 5 years, and >5 years, respectively (P=0.037). Externalized leads had a significantly pronounced decrease in R-wave amplitude (−1.7±2.9 mV versus +0.35±2.5 mV; P<0.001), and more patients with externalized leads had ≥25% decrease in R-wave amplitude from baseline (28.0% versus 8.1%; P=0.018). One patient with externalization exhibited new noise on near-field electrogram. Conclusions— The Riata lead exhibits time-dependent high rates of cable externalization exceeding 20% at >5 years of dwell time. Externalized leads are associated with a more pronounced decrease in R-wave amplitude, which may be an early marker of future electric failure. The use of fluoroscopic and electric screening of asymptomatic patients with the Riata lead remains controversial in the management of patients affected by the recent Food and Drug Administration recall.

Complications of replacing implantable devices in response to advisories: A single center experience

Late intracardiac lead perforation is defined as migration and perforation of an implanted lead after 1 month of cardiac electronic device implantation. It is an under‐recognized complication with significant morbidity and mortality, particularly if not recognized early. Two patients with late perforation caused by passive‐fixation leads are reported and the clinical features of their presentation and management are reviewed. We conducted a thorough review of the available English language literature pertaining to this complication to draw relevant conclusions regarding presentation, diagnosis, and management. Early recognition of this complication is important as the indications for and numbers of patients who receive cardiac implantable electronic devices continue to expand. Copyright

Health and Economic Outcomes Associated with Use of an Antimicrobial Envelope as a Standard of Care for Cardiac Implantable Electronic Device Implantation

BACKGROUND Advisories for implanted devices present a challenging management problem since no specific guidelines exist for device replacement under these circumstances. Since the rate and severity of complications is an important factor in the decision-making, we sought to review our experience with replacement of devices under advisory. METHODS Medical records of patients with devices under advisory were reviewed. A total of 237 patients (age 68+/-13 years, men 71%, implantable cardioverter-defibrillator (ICD) 87%) underwent device replacement in response to advisories (Medtronic Inc. 43% and Guidant Inc. 57%) at our institution between February 2005 and June 2006. RESULTS The mean time from original device implantation to replacement was 31+/-16 months (3-73 months). During a mean follow-up of 198+/-103 days, there was a 5.5% overall rate of complications related to the procedure. Major complications requiring re-operation affected 2.1% of patients. There were no deaths associated with device replacement. Device failure prior to replacement was documented in 1.7% of patients, with syncope occurring in one patient. A history of diabetes mellitus (23%), peripheral vascular disease (4%), obstructive lung disease (7%), end-stage renal disease (2%), or use of anticoagulation (44%) did not predict the occurrence of complications after advisory device replacement. CONCLUSION This single center experience shows a lower major complication rate from replacement of devices under advisory than previously reported. Experience from this center and others may be useful in guiding future management of patients in the setting of device advisories.

Beta-blocker Utilization and Outcomes in Patients Receiving Cardiac Resynchronization Therapy

Infection of cardiac implanted electrical devices (CIED) is a problem. In selected patients, use of an “antibacterial envelope” (AIGISRx®) is associated with low CIED infection rates. The value of this device when used as a standard of care is unclear.

Microvolt T-wave alternans during atrial and ventricular pacing

Optimal pharmacologic therapy (OPT) is considered a prerequisite to consideration for cardiac resynchronization therapy (CRT).