How to implant a phrenic nerve stimulator for treatment of central sleep apnea?

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 remede System, Respicardia, Inc). METHODS: The remede 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 remede 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.

Appropriate Classification and Filtering of Electromagnetic Interference by the S-ICD Sensing Algorithm During Surgery.

The subcutaneous implantable cardioverter defibrillator (S-ICD) is a new device used for the prevention of sudden cardiac death. Best practices in the perioperative management of the S-ICD are not established; therefore, clinicians typically deactivate the device during surgery, with reinterrogation and activation postoperatively. This could put the patient at risk for being discharged with the device "off." We present two cases where electromagnetic interference was appropriately detected by the S-ICD and filtered. These cases present an important clinical finding that could lead to less deactivation of devices during surgery. Further research will be required to define which surgical procedures require magnet, reprogramming, or no changes.

Use of a custom-designed adapter to manage ICD lead fracture.

We report the case of a 72-year-old patient with ischemic cardiomyopathy who was found to have a lead fracture in the RV coil DF-1 connector of an integrated bipolar implantable cardioverter-defibrillator (ICD) lead system at the time of upgrade to a biventricular ICD. Due to the redundant connection of the RV coil to the DF-1 connector and the ring on the IS-1 connector, a custom-designed adapter was used to exclude the site of fracture. This novel solution spared the patient the potential risks of lead extraction or abandoning the fractured ICD lead. In this way, pacing and defibrillating capabilities were fully restored, providing the patient 6 years of optimal device functioning.

On-treatment comparison between corrective His bundle pacing and biventricular pacing for cardiac resynchronization: A secondary analysis of the His-SYNC Pilot Trial.

BACKGROUND: The His-SYNC pilot trial was the first randomized comparison between His bundle pacing in lieu of a left ventricular lead for cardiac resynchronization therapy (His-CRT) and biventricular pacing (BiV-CRT), but was limited by high rates of crossover. OBJECTIVE: To evaluate the results of the His-SYNC pilot trial utilizing treatment-received (TR) and per-protocol (PP) analyses. METHODS: The His-SYNC pilot was a multicenter, prospective, single-blinded, randomized, controlled trial comparing His-CRT vs BiV-CRT in patients meeting standard indications for CRT (eg, NYHA II-IV patients with QRS >120 ms). Crossovers were required based on prespecified criteria. The primary endpoints analyzed included improvement in QRS duration, left ventricular ejection fraction (LVEF), and freedom from cardiovascular (CV) hospitalization and mortality. RESULTS: Among 41 patients enrolled (aged 64 ± 13 years, 38% female, LVEF 28%, QRS 168 ± 18 ms), 21 were randomized to His-CRT and 20 to BiV-CRT. Crossover occurred in 48% of His-CRT and 26% of BiV-CRT. The most common reason for crossover from His-CRT was inability to correct QRS owing to nonspecific intraventricular conduction delay (n = 5). Patients treated with His-CRT demonstrated greater QRS narrowing compared to BiV (125 ± 22 ms vs 164 ± 25 ms [TR], P < .001;124 ± 19 ms vs 162 ± 24 ms [PP], P < .001). A trend toward higher echocardiographic response was also observed (80 vs 57% [TR], P = .14; 91% vs 54% [PP], P = .078). No significant differences in CV hospitalization or mortality were observed. CONCLUSIONS: Patients receiving His-CRT on-treatment demonstrated superior electrical resynchronization and a trend toward higher echocardiographic response than BiV-CRT. Larger prospective studies may be justifiable with refinements in patient selection and implantation techniques to minimize crossovers.

New simplified technique for 3D mapping and ablation of right ventricular outflow tract tachycardia.

OBJECTIVE: To evaluate the safety and efficacy of using a circular multielectrode catheter for mapping and ablation of ventricular tachycardia (VT) or premature ventricular complexes (PVCs) from the right ventricular outflow tract (RVOT). BACKGROUND: Three-dimensional (3D) mapping systems are commonly used for mapping and ablation of RVOT VT and PVCs. Newer catheters that are circular with multiple electrodes, such as the Lasso catheter, are capable of simultaneously recording from multiple points within a circumferential plane. Given the tubular structure of the RVOT, these catheters could be used for mapping tachycardias from the RVOT. METHODS: A retrospective cohort study of patients undergoing radiofrequency (RF) ablation of RVOT VT or PVCs was performed. In group 1 (n = 7), mapping was performed with a single ablation catheter and fluoroscopy. In group 2 (n = 10), 3D mapping using ESI (n = 9) or CARTO (n = 1) was performed. In group 3 (n = 12), mapping was performed with a circular multielectrode catheter (n = 12). All ablations were performed with 4-mm tip catheters using RF energy. RESULTS: Catheter ablation for RVOT VT (n = 15) or PVCs (n = 14) was performed on 29 cases in 26 patients, 9 males. Mean age was 35.9 years. In groups 1, 2, and 3, the mean number of lesions was 17.7 +/- 7.7, 13.6 +/- 7.7, and 18.2 +/- 22.7 and the median number of lesions was 20, 13, and 5, respectively. There were no significant differences in the number of lesions, RF time, fluoroscopy time, procedure time, and acute success rate among the three techniques. There were three complications in group 2 and one in group 3. CONCLUSION: The use of a circular multielectrode catheter is as effective as the other standard available 3D mapping techniques, both in terms of procedural success and procedural characteristics. Additionally, because of the lower cost associated with using the circular multielectrode catheter approach, further evaluation should be performed to determine whether this is the most cost-effective approach to 3D mapping and ablation of RVOT tachycardias.