Ralph Augostini

Background: Implantable cardioverter-defibrillator (ICD) therapy prevents sudden cardiac death in selected patients with heart failure. When a primary prevention ICD arrives at elective replacement interval (ERI), conventional management is to replace the device. However, the effectiveness of ICDs in patients with nonischemic and ischemic cardiomyopathy (NICM and ICM, respectively) whose left ventricular ejection fraction (LVEF) improved to ≥50% before replacement is unclear. Hypothesis: The therapeutic benefit of primary prevention ICD for NICM is attenuated by the recovery of LVEF at the time of ERI. Methods: Consecutive patients presenting for first time primary prevention ICD battery change-out at a single quaternary care center between 1/1/2008 and 6/27/2019 were included. The primary endpoint was the rate of ICD therapy (ICD discharge and anti-tachycardia pacing) according to LVEF recovery at ERI. Results: During the study period 6851 ICDs were placed, of which 310 underwent battery change-out, of whom 100 did not receive therapy from the first ICD, of whom 44 had NICM. The demographics of the NICM cohort are in the table. Following ERI, 0 (0%) with NICM and recovered LVEF had received ICD therapy, whereas 13 (30%) with persistently low LVEF had received therapy (p = 0.07). Furthermore, among patients without recovered LVEF, the NICM group had a lower rate of therapy (4, 12%) than the ICM group (12, 32%) (p=0.04). Conclusion: Rates of ICD therapy provided by primary prevention ICD after first battery change out trended towards a significantly lower rate in NICM patients with LVEF that recovered to ≥50% than those without LVEF recovery. No other patient demographic significantly predicted therapy-free survival but the analysis was limited by sample size. A prospective study with a larger cohort would be necessary to better estimate therapy-free survival. Download figure

Background: An internal risk stratification algorithm was developed to decrease the risk of major adverse cardiac events (MACEs) during lead extractions (LEs).Objective: To report upon the impact of a risk stratification algorithm (RISE [RIsk Stratification prior to lead Extraction] protocol) on outcomes of LEs in a high‐volume center.Methods: A retrospective review of a prospectively maintained LEs database was performed to identify features associated with MACEs. On the basis of the retrospective data, the RISE protocol differentiated LEs procedures into “High” and “Low” risk for occurrence of MACEs. High‐risk LEs included dual‐coil defibrillator lead (≥3 years), pacemaker and single‐coil lead (≥5 years), and any StarFix coronary sinus lead. During the prospective evaluation of the RISE protocol, “High‐risk” LEs were performed in an operating room (OR) or hybrid laboratory with the cardiac anesthesiologist, OR nursing team, perfusionist in the room, and a cardiac surgeon on the premises. “Low‐risk” LEs were performed in the electrophysiology (EP) laboratory with anesthesia provided by EP nursing team. The preintervention (pre‐RISE) and postintervention (post‐RISE) group spanned 19 and 40 months and consisted of 449 (632 leads) and 751 patients (1055 leads), respectively. The primary outcome of MACEs in the two groups was compared.Results: Protocol compliance was 100%. The primary outcome of MACEs occurred in 15 patients (3.34%) before and 12 (1.6%) after implementation of the RISE protocol (P = .04).Conclusion: RISE identified a low‐risk group where minimal resources are needed and allowed for rapid intervention in the high‐risk group that reduced the consequences of MACEs.

Background: Central sleep apnea (CSA) is a breathing disorder caused by the intermittent absence of central respiratory drive. Transvenous phrenic nerve stimulation is a new therapeutic option, recently approved by the FDA , for the treatment of CSA.Objective: To describe the technique used to implant the transvenous phrenic nerve stimulation system (the remedē System, Respicardia, Inc).Methods: The remedē System is placed in the pectoral region, typically on the right side. A single stimulation lead is placed in either the left pericardiophrenic vein (PPV) or the right brachiocephalic vein (RBC). A sensing lead is placed into the azygous vein to detect respiration.Results: In the remedē System Pivotal trial, 147 of 151 (97%) patients were successfully implanted with the system. Sixty‐two percent of stimulation leads were placed in the PPV and 35% in the RBC. Mean procedure time was 2.7 ± 0.8 hours and 94% of patients were free from implant‐related serious adverse events through 6 months.Conclusion: In patients with CSA, transvenous phrenic nerve stimulation is an effective and safe therapy with an implant procedure similar to that of cardiac implantable electronic devices.

Background: The Subcutaneous (SQ) Implantable Cardioverter Defibrillator (ICD) requires defibrillation testing at the time of implantation. Predictors of defibrillation success based upon the anterior and posterior position of the pulse generator have been identified through computer modeling.

Background: Transcatheter aortic valve replacement (TAVR) can lead to atrioventricular (AV) conduction changes and need for permanent pacemaker (PPM) implantation. There is currently no consensus on clinical decision making for PPM evaluation in patients undergoing TAVR.