Successful New Generation LAA Closure Device Implantation After Prior Incomplete Surgical LAA Ligation.

We present a case of percutaneous closure of a prior incomplete surgical left atrial appendage (LAA) ligation after a failed closure attempt using the first-generation Watchman device. The new generation Watchman FLX device (Boston Scientific) was implanted in this technically and anatomically challenging LAA patient using multimodality fusion imaging. (Level of Difficulty: Advanced.).

Antibacterial Envelope Is Associated With Low Infection Rates After Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Device Replacement: Results of the Citadel and Centurion Studies.

OBJECTIVES: This study sought to determine whether the nonabsorbable TYRX Antibacterial Envelope (TYRX) reduces major cardiovascular implantable electronic device (CIED) infections 12 months after implant. BACKGROUND: TYRX is a monofilament polypropylene mesh impregnated with minocycline and rifampin specifically designed to hold a CIED in place and elute antimicrobials over time. There are limited data on its ability to reduce CIED infections. METHODS: We prospectively enrolled patients who underwent generator replacement with an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy device (CRT), treated with TYRX. The primary endpoints were major CIED infection and CIED mechanical complications. Given the differences in infection rates among ICD and CRT patients, 3 different control populations were used: a published benchmark rate for ICD patients, and both site-matched and comorbidity-matched controls groups for CRT patients. RESULTS: Overall, a major CIED infection occurred in 5 of 1,129 patients treated with TYRX (0.4%; 95% confidence interval: 0.0% to 0.9%), significantly lower than the 12-month benchmark rate of 2.2% (p = 0.0023). Among the TYRX-treated CRT cohort, the major CIED infection rate was 0.7% compared with an infection rate of 1.0% and 1.3% (p = 0.38 and p = 0.02) in site-matched and comorbidity-matched control groups, respectively. Among the ICD group, the 12-month infection rate was 0.2% compared with the published benchmark of 2.2% (p = 0.0052). The most common CIED mechanical complication in study patients was pocket hematoma, which occurred in 18 of the 1,129 patients (1.6%; 95% confidence interval: 0.8 to 2.5), which is comparable with a published rate of 1.6%. CONCLUSIONS: Use of TYRX was associated with a lower major CIED infection rate. (TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD; [Centurion]; NCT01043861/NCT01043705).

A pilot study of cardiac electrophysiology catheters to map and pace bladder electrical activity.

AIMS: This is a pilot study to evaluate the feasibility of using diagnostic cardiac electrophysiology catheters for recording intrinsic urinary bladder electrical activity and for electrical pacing capture of bladder tissue. METHODS: During cystoscopy, a curved quadripolar catheter was introduced and contact was made with the right and left halves of the dome and trigone in adult female patients undergoing cystoscopy. Electrical activity was recorded, using a commercially available cardiac electrophysiologic recording system, before and during pacing at 0.5-3.0 Hz. RESULTS: Apparent spontaneous electrical depolarizations were detected in both the trigone and the dome. The amplitude of these depolarizations was in the microVolt range. During pacing, local electrical capture was noted in the trigone, but not in the dome. CONCLUSIONS: Spontaneous low-amplitude electrical activity was detected in the bladder through the use of commercially available cardiac electrophysiology equipment. While these low-level signals could represent noise, the voltage, and morphology resemble detrusor muscle action potentials previously seen in animal studies. Pacing induced local electrical capture in the trigone but not the dome.

Investigation of the Utility of the Audible Alert in Recent Generation Medtronic Implantable Cardioverter Defibrillators.

BACKGROUND: Medtronic implantable cardioverter defibrillators (ICDs; Medtronic Inc., Mounds View, MN, USA) are equipped with Patient Alert™, a feature in which the ICD generator emits a series of audible tones to notify patients of possible system malfunction. A prior study of this issue revealed that only 50% of patients with older Medtronic devices were able to hear alerts. More recently, Medtronic has incorporated modifications to the alert. Therefore, we studied how frequently alert tones emitted by the current generation of Medtronic ICDs are audible by patients. METHODS: A series of patients were evaluated in an outpatient ICD clinic. Alert tones were demonstrated using a device programmer in a quiet room and in the presence of low-level background noise. Patients reported whether they heard the tones, and they completed questionnaires regarding the tones. RESULTS: The total sample size was 100 patients, 81 male, who ranged from 29 years to 94 years of age (mean age 72.1 ± 11.8). Among the study subjects, 46% were older than 75 years, 41% were between 55 years and 75 years, and 13% were younger than 55 years. In the absence of background noise, 94% of patients were able to hear both alerts, 1% heard only one alert, and 5% heard neither. In the presence of background noise, 88% of patients heard both the alerts, 7% heard only one alert, and 5% heard neither alerts. CONCLUSIONS: Our results demonstrate that alert tones in recent generation Medtronic ICDs have improved audibility, compared to prior published data, among a large outpatient ICD population.

The prevalence of sinus rhythm in patients with "permanent" atrial fibrillation.

BACKGROUND: The term "permanent" atrial fibrillation (AF) is generally used to describe the rhythm status of patients for whom cardioversion has failed or attempts to restore normal sinus rhythm (NSR) have ceased. However, the rhythm status of such patients is typically assessed by symptoms or intermittent monitoring, and therefore categorization may be imprecise. METHODS: We evaluated the presence of NSR among patients who were identified by their physicians as having permanent AF and who underwent prior insertion of a cardiac rhythm management device in the OMNI study. Patients with a dual- or triple-chamber device (pacemaker, implantable cardiac defibrillator, or cardiac resynchronization therapy) and ≥30 days of device data were studied. We tabulated the percentage of follow-up days spent entirely in NSR, entirely in AF, or in both NSR and AF. RESULTS: A total of 69 patients met inclusion criteria and were followed for 767 ± 479 days. More than 73% of patients experienced ≥1 entire day in NSR. On average, 38.2% of days were spent entirely in NSR, 11.8% of days were spent in a combination of NSR and AF, and only 50.0% of days were spent entirely in AF. The median daily AF burden during follow-up was 14.6 [1.1-23.7] hours/day. CONCLUSIONS: NSR is common in many device patients thought to have permanent AF, suggesting that continuous arrhythmia monitoring could be useful in identifying permanent AF patients who may benefit from renewed rhythm control efforts. Alternatively, some permanent AF patients undergoing atrioventricular nodal ablation may benefit from dual-chamber devices due to likely periods of NSR.

Magnetic resonance imaging diagnosis of left atrial abscess after ablation of atrial fibrillation.

We report a 52-year-old patient with a late presentation of a fistula that occurred after catheter ablation for atrial fibrillation. A secondary left atrial wall abscess was diagnosed by upper endoscopy and cardiac magnetic resonance imaging. Emergency operative repair was successful, with no adverse cardiac or gastrointestinal sequelae.

Implantation success and infection in cardiovascular implantable electronic device procedures utilizing an antibacterial envelope.

BACKGROUND: Cardiovascular implantable electronic device (CIED) infection rates are increasing faster than implantation rates. More effective antimicrobial prophylaxis may help reduce CIED infections and improve clinical outcomes. The AIGIS(Rx)(®) antibacterial envelope is a polymer mesh implanted in the generator pocket with the CIED. After implantation it releases two antibiotics, minocycline and rifampin, that have been shown to reduce infections associated with other medical devices. The purpose of this retrospective cohort study is to determine the rate of CIED implantation success and CIED infection in procedures utilizing the antibacterial envelope. METHODS: This study enrolled consecutive CIED procedures utilizing the antibacterial envelope at 10 US academic, community, and Veterans Affairs medical centers. Procedures following an explantation for a prior CIED infection or off-label use of the antibacterial envelope were excluded. RESULTS: The 624 eligible procedures (age 70 ± 13 years, 68.1% men, 27.2% renal insufficiency, 35.4% oral anticoagulant use, 67.8% replacement/revision procedures) utilized pacemakers (35%), implantable cardioverter-defibrillators (ICD)(29%), and cardiac resynchronization therapy with defibrillator devices (CRT-D)(36%). Nearly half of the patients (49%) had at least three predefined risk factors for CIED infection. CIED implantation was successful in 621 procedures (99.5%[95% confidence interval (CI) 98.8-99.9]). There were three major infections (0.48%[95%CI 0.17-1.40]) after 1.9 ± 2.4 months follow-up. The infections followed one ICD revision and two CRT-D replacements. There were seven deaths; none was a result of the antibacterial envelope or the CIED procedure. CONCLUSIONS: CIED procedures that utilized an antibacterial envelope had a high rate of CIED implantation success (>99%). Although the follow-up to date is short, there was also a low rate of infection (<0.50%) in this population at high risk for CIED infection.

Alert tones are frequently inaudible among patients with implantable cardioverter-defibrillators.

BACKGROUND: Current management guidelines for patients with Medtronic Sprint Fidelis ICD leads (Medtronic Inc., Minneapolis, MN, USA) include prominent use of Patient Alert, a feature in which the ICD generator emits audible beeps at two programmable frequencies. Because hearing loss is highly prevalent beyond the sixth decade of life, the utility of this feature is unclear. Therefore, we conducted a survey of patients' ability to hear the Medtronic Patient Alert. METHODS: During visits to an outpatient device clinic, patients with Medtronic ICDs were evaluated for their ability to hear ICD tones. RESULTS: The patient group consisted of 102 patients. Patients older than 70 years comprised 68% of the sample, with 16% between 60 and 70, and 17% younger than 60 years. Of the 102 patients, 59% (56% of males and 70% of females) were able to hear at least one tone. Ability to hear ICD tones decreased with advancing age. Among patients over 60 and 70 years, 52% and 43%, respectively (P < 0.001 vs. patients below 60 and 70 years), could hear at least one tone. CONCLUSIONS: The Patient Alert feature is not useful among a large proportion of ICD patients. Patients with Sprint Fidelis leads should be evaluated for their ability to hear audible ICD tones. For patients who cannot hear the Patient Alert feature, a wireless remote monitoring and/or daily application of a magnet by a caregiver should be considered. Device manufacturers should include nonauditory alert technologies such as wireless remote monitoring and vibratory stimulation in future devices.

Use of the retained guidewire technique facilitates left ventricular epicardial capture during biventricular defibrillator implantation.

We report a case of biventricular implantable cardioverter-defibrillator (ICD) insertion in which standard lead placement techniques could not achieve left ventricular capture. Protrusion of the guidewire beyond a venous stenosis provided adequate left ventricular capture.

Continuous nonfluoroscopic localization of the esophagus during radiofrequency catheter ablation of atrial fibrillation.

INTRODUCTION: Atrial-esophageal fistula formation is a dreaded complication of radiofrequency catheter ablation for atrial fibrillation. Esophageal localization is of potential value in avoiding lesion placement where the left atrium is juxtaposed to the esophagus. METHODS AND RESULTS: Twenty-seven patients underwent 33 pulmonary vein encirclement procedures. All the patients received general anesthesia with inhalational agents and either a fenestrated laryngeal mask airway or an endotracheal tube. A diagnostic electrophysiologic catheter was inserted into the esophagus, and a virtual esophageal tube was created using an electroanatomic mapping system. In all cases, the catheter was placed without difficulty and satisfactory virtual esophageal images were created. The catheter remained in the esophagus until the end of each ablation procedure. Esophageal catheter location during and after the ablation was compared with the initial location. Areas of close proximity between the left atrium and esophagus were easily identified. Change in esophageal location was not observed. Identification of esophageal proximity to the pulmonary veins allowed for identification of high-risk cases. In such cases, the planned procedure was modified to avoid esophageal injury (12 of 27 patients). CONCLUSIONS: (1) Real-time localization of esophageal position using a nonfluoroscopic mapping system during atrial fibrillation ablation is safe, practical, and straightforward. (2) Among patients who receive general anesthesia, esophageal position appears to be static, suggesting that one initial virtual image is sufficient for the duration of an ablation procedure.

Use of a sterile, disposable, radiation-absorbing shield reduces occupational exposure to scatter radiation during pectoral device implantation.

The aim of this study was to demonstrate the effectiveness of a radiation-absorbing shield in reducing physicians' occupational radiation exposure during pectoral device implantation. A sterile, disposable, lead-free radiation-absorbing surgical drape containing x-ray attenuation material was evaluated. Twenty procedures used the radiation absorbing drape, and 20 were performed without the shielding. Radiation exposure was measured using thermoluminescent dosimetry collar badges. Use of the protective shield was associated with a time adjusted 80% reduction in radiation dose (0.009 mrem/s with shielding vs 0.047 mrem/s without shielding, P < 0.05) to the physician performing the procedures. The radiation-absorbing surgical drape did not interfere with technical performance nor add procedural time, and all procedures were successfully completed. This study demonstrates that a sterile, disposable, radiation-absorbing drape provides a convenient means of augmenting conventional radiation shielding. Use of this protective shielding greatly reduces operators' occupational exposure to scatter radiation during pectoral device implantation without compromising sterility or procedural technique.