Friedman, Paul A.

AbstractBackgroundImplantable loop recorders (ILRs) are effective in achieving symptom‐rhythm correlation. However, diagnostic yield in routine clinical practice is not well established.MethodsPatients undergoing ILR implantation between April 2010 and May 2015 were included. All devices were enrolled in remote monitoring with automatic arrhythmia detection and P sense algorithms switched “ON.” Symptom‐rhythm correlation was assessed and changes in management were recorded.ResultsA total of 312 patients (57% male, age 53 ± 22 years; median CHADS2VaSc score = 1) were included in this study. ILRs were implanted for evaluation of syncope in 206 (66.0%), presyncope in 23 (7.4%), unexplained palpitations in 51 (16.3%), and cryptogenic stroke in 27 (8.7%) patients. ILR monitoring yielded a diagnosis that changed management strategy in 146 (46.8%) patients over a median of 12 (1‐42) months. Out of 163 (52.2%) patients with symptoms during the monitoring period, 100 (61.3%) had an arrhythmia. ILR was useful in ruling out an arrhythmic cause for symptoms in 63 (38.7%) patients. ILR results led to pacemaker implantation in 23 patients (7.4% overall and 11.2% of those with syncope) after median follow‐up of 3 months. A new diagnosis of atrial fibrillation was made in 38 (12.2%) patients, 11 of whom were initiated on oral anticoagulants. ILR results led to pacemaker implantation in 31 patients (9.9% overall and 19.0% of those with syncope) after median follow‐up of 3 months. A new diagnosis of atrial fibrillation was made in 38 (12.2%) patients, nine of whom were initiated on oral anticoagulants. Overall, ILR led to a change in management in 47% patients with a number needed to implant of 2.1 to change management.ConclusionILR monitoring is effective in achieving symptom‐rhythm correlation and results in changes in management in nearly half of implanted patients. Additional studies are needed to evaluate cost efficacy of ILR and the optimal monitoring duration.

Level of Evidence: 1Technical Efficacy Stage: 5 J. Magn. Reson. Imaging 2019;49:e297–e299.

Background— The effectiveness of implantable cardioverter-defibrillators (ICDs) for primary prevention of sudden death in patients with an ejection fraction (EF) ≤35% and clinical heart failure is well established. However, outcomes after replacement of the ICD generator in patients with recovery of EF to >35% and no previous therapies are not well characterized. Methods and Results— Between 2001 and 2011, generator replacement was performed at 2 tertiary medical centers in 253 patients (mean age, 68.3±12.7 years; 82% men) who had previously undergone ICD placement for primary prevention but subsequently never received appropriate ICD therapy. EF had recovered to >35% in 72 of 253 (28%) patients at generator replacement. During median (quartiles) follow-up of 3.3 (1.8–5.3) years after generator replacement, 68 of 253 (27%) experienced appropriate ICD therapy. Patients with EF ≤35% were more likely to experience ICD therapy compared with those with EF >35% (12% versus 5% per year; hazard ratio, 3.57; P =0.001). On multivariable analysis, low EF predicted appropriate ICD therapy after generator replacement (hazard ratio, 1.96 [1.35–2.87] per 10% decrement; P =0.001). Death occurred in 25% of patients 5 years after generator replacement. Mortality was similar in patients with EF ≤35% and >35% (7% versus 5% per year; hazard ratio, 1.10; P =0.68). Atrial fibrillation (3.24 [1.63–6.43]; P <0.001) and higher blood urea nitrogen (1.28 [1.14–1.45] per increase of 10 mg/dL; P <0.001) were associated with mortality. Conclusions— Although approximately one fourth of patients with a primary prevention ICD and no previous therapy have EF >35% at the time of generator replacement, these patients continue to be at significant risk for appropriate ICD therapy (5% per year). These data may inform decisions on ICD replacement.

Background The decision to initially implant an implantable cardioverter-defibrillator (ICD) is informed by robust randomized controlled trials, but no such data exist to guide the decision to replace an ICD generator. In this study, we aimed to determine outcomes after ICD generator replacement. Methods All patients with ischemic or nonischemic cardiomyopathy who underwent ICD generator replacement from 2001 to 2011 at Mayo Clinic, MN, or Beth Israel Deaconess Medical Center, MA, were included. Outcomes included (1) appropriate therapy after generator replacement and (2) death before appropriate therapy after generator replacement. Cox proportional hazards modeling was used to determine the associations between patient characteristics and outcomes. Results In 1421 patients undergoing ICD generator replacement (mean±SD age 69.6±12.1 years, 81% male), appropriate therapy occurred after replacement in 435 patients (30.6%) over a mean follow-up of 2.7±2.6 years. Associated factors included lower left ventricular ejection fraction and history of appropriate therapy before generator replacement. Death before appropriate ICD therapy occurred in 336 (23.7%) patients. Older age, lower left ventricular ejection fraction, and noncardiac comorbidities, including diabetes mellitus, chronic lung disease, peripheral vascular disease, lower hemoglobin, and lower glomerular filtration rate, were associated with greater risk of death before appropriate therapy. A progressive increase in mortality was observed with aggregation of these noncardiac comorbidities. Conclusions The decision to replace the ICD should take into consideration not only left ventricular ejection fraction and history of ventricular arrhythmias, but also comorbid illnesses that may impact the duration and the quality of life.

AbstractIntroductionThe outcomes of repeated cardiovascular implantable electronic device (CIED) lead extraction have not been well studied. We sought to determine the indications, outcomes, and safety of repeated lead extraction procedures.MethodsThis retrospective study was conducted using data from two medical centers, including 38 patients who had undergone two or more lead extraction procedures compared to 439 patients who had a single procedure. The electronic medical records and procedural databases were reviewed to determine the indications, procedural characteristics, and outcomes. The outcomes of the first procedure were compared to the outcomes of subsequent procedures.ResultsThe 5‐year cumulative probability of a repeated extraction procedure was 11% (95% confidence interval, 7%–15%). In 439 patients who underwent single lead extractions, 72% had device and lead related infections as the procedure indication compared to 39% for 38 patients who underwent repeated extraction (P < 0.001). The mean duration from device reimplant to repeated extraction procedures was 63 ± 48 months. Ninety‐eight percent of the leads were removed completely in repeated procedures, similar to the 95% success rate of the first procedure (P = 0.51). There was no significant difference in major complication rate in the first or repeated extractions (2.6% vs 5.2%, P = 0.79).ConclusionsRepeated transvenous lead extraction is not uncommon. It had a high success rate comparable to that of the initial procedure and was not associated with an increased incidence of adverse events.

AbstractBackgroundTransvenous lead implantation has multiple drawbacks and complications that can be overcome by epicardial lead placement. We aimed to design percutaneously implanted epicardial leads that are anchored through the transverse sinus (TS).Methods and resultsWe designed a novel multielectrode pacing device with four bipole electrode pairs. The device is advanced through the TS, with both ends externalized out of the pericardium. We tested the prototype in one proof‐of‐concept and 5 additional acute canine experiments.The TS device recorded ventricular and atrial electrograms. The median amplitude of near‐field ventricular electrograms was 3.3 mA (IQR 2.0–4.3) and of near‐field atrial electrograms was 2.1 mA (IQR 1.3–2.2). The median ventricular threshold (N = 30) was 1.1 mA (IQR 0.7–3.1) at a median pulse width of 0.5 ms (IQR 0.5–0.5). The median atrial threshold (N = 10) was 2.4 mA (IQR 1.1–7.8) at a median pulse width of 0.5 ms (IQR 0.5–0.9). Right and left ventricular and atrial pacing morphologies were noted while pacing electrodes adjacent to these chambers. Simultaneous left (LV) and right ventricular (RV) pacing showed reduction in QRS duration from 116 ms (RV) and 105 ms (LV) to 91 ms. On necropsy, the device was located in the TS in all animals. There were TS abrasions in one animal, and no other acute complications.ConclusionsThis study highlights a novel approach to epicardial pacing harnessing the unique anatomy of the transverse sinus as an anchoring point. Placement of this novel transverse sinus device was safe and feasible, with acceptable atrial and ventricular thresholds.

AbstractBackgroundQRS fragmentation (fQRS) during baseline ventricular conduction, a myocardial fibrosis marker, is associated with increased risk of ventricular tachyarrhythmias but may not manifest unless ventricular activation change is provoked. We examined the association of fQRS during right ventricular (RV) pacing with death and ventricular tachyarrhythmia in patients with left ventricular (LV) dysfunction undergoing electrophysiology study (EPS).Methods and resultsStudy participants had LV dysfunction (ejection fraction < 50%) undergoing EPS from January 2002 to May 2014 at Mayo Clinic in Rochester, Minnesota. fQRS during RV stimulation involved >2 notches on R/S waves identified in ≥2 contiguous standard electrocardiographic leads representing anterior, inferior, or lateral ventricular segments. Primary outcomes were ventricular tachyarrhythmias that were symptomatic or required intervention and total and cardiac deaths. In all, 528 patients participated (mean age, 65 years; male sex, 80%). Of them, 312 (59%) had ischemic cardiomyopathy and mean (SD) left ventricular ejection fraction (LVEF) of 33.2% (9.5%); 457 (87%) had implantable cardiac devices (implanted defibrillator, n = 380). Mean (SD) follow‐up was 3.2 (3.0) years. fQRS during RV pacing was observed in 292 patients (60%) in any ventricular segment. Patients with fQRS during RV pacing had 2.5 higher rate of ventricular tachyarrhythmia events than patients with no fQRS (hazard ratio [95% CI], 2.45 [1.5–4.2]; P < 0.01), after correcting for baseline ventricular conduction defect and QRS duration, LVEF, inducible sustained ventricular tachycardia, diabetes mellitus, chronic kidney disease, and ischemic cardiomyopathy.ConclusionsRV stimulation can unmask fQRS, and it is associated with increased risk of ventricular tachyarrhythmia in LV dysfunction.

AbstractIntroductionTo evaluate the outcomes of video‐assisted thoracoscopic surgery (VATS) during transvenous lead extractions (TLEs).Methods and resultsNinety‐one high‐risk patients who underwent TLE in the operating room from January 1, 2015, to March 31, 2017, were included in the study. Of these, 9 patients underwent VATS during TLE. Their clinical characteristics, indications for lead extraction, and complications associated with TLE in the 9 patients who had VATS were compared with those for the 82 patients who did not have VATS. The mean (SD) age of the study patients was 61 (17) years (64.8% were male). The lead dwell time, number of leads extracted, and clinical comorbidities were similar between the 2 groups. Superior vena cava (SVC) tear occurred in 2 of the 9 patients in VATS group and in 1 of the 82 in the non‐VATS group (22.2% vs. 1.2%, P = 0.03). Of the 2 patients in the VATS group who had SVC tears, in 1 the tear was visualized immediately and there was no hemodynamic compromise. In the other patient, the SVC tear was within the pericardium; the blood pressure recovered quickly after sternotomy and repair. Both patients had complete lead extraction and survived hospitalization. The patient in the non‐VATS group who had an SVC tear had a successful repair but died of postoperative complications.ConclusionsUtilization of VATS to facilitate TLE is beneficial for early recognition of SVC tear and timely surgical repair in select high‐risk patients.