Search

A wearable cardioverter defibrillator (WCD) is indicated in appropriate patients to reduce the risk for sudden cardiac death. Challenges for patients wearing a WCD have been frequent false shock alarms primarily due to electrocardiogram noise and wear discomfort. The objective of this study was to test a contemporary WCD designed for reduced false shock alarms and improved comfort.One hundred and thirty patients with left ventricular ejection fraction ≤40% and an active implantable cardioverter defibrillator (ICD) were fitted with the ASSURE WCD (Kestra Medical Technologies) and followed for 30 days. WCD detection was enabled and shock alarm markers recorded, but shocks and shock alarms were disabled. All WCD episodes and ICD ventricular tachycardia/ventricular fibrillation (VT/VF) episodes were adjudicated. The primary endpoint was the false-positive shock alarm rate with a performance goal of 1 every 3.4 days (0.29 per patient-day).Of 163 WCD episodes, 4 were VT/VF and 159 non-VT/VF (121 rhythms with noise, 32 uncertain with noise, 6 atrial flutter without noise). Only three false-positive shock alarm markers were recorded; one false-positive shock alarm every 1333 patient-days (0.00075 per patient-day, 95% confidence interval: 0.00015-0.00361; p .001). No ICD recorded VT/VF episodes meeting WCD detection criteria (≥170 bpm for ≥20 s) were missed by the WCD during 3501 patient-days of use. Median wear was 31.0 days (interquartile range [IQR] 2.0) and median daily use 23.0 h (IQR 1.7). Adverse events were mostly mild: skin irritation (19.4%) and musculoskeletal discomfort (8.5%).The ASSURE WCD demonstrated a low false-positive shock alarm rate, low patient-reported discomfort, and no serious adverse events.

Purpose Catheter ablation has become a mainstay therapy for atrial fibrillation (AF) with rapid innovation over the past decade. Variability in ablation techniques may impact efficiency, safety, and efficacy; and the ideal strategy is unknown. Real-world evidence assessing the impact of procedural variations across multiple operators may provide insight into these questions. The Real-world Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation registry (Real-AF) is a multicenter prospective registry that will enroll patients at high volume centers, including academic institutions and private practices, with operators performing ablations primarily with low fluoroscopy when possible. The study will also evaluate the contribution of advent in technologies and workflows to real-world clinical outcomes. Methods Patients presenting at participating centers are screened for enrollment. Data are collected at the time of procedure, 10–12 weeks, and 12 months post procedure and include patient and detailed procedural characteristics, with short and long-term outcomes. Arrhythmia recurrences are monitored through standard of care practice which includes continuous rhythm monitoring at 6 and 12 months, event monitors as needed for routine care or symptoms suggestive of recurrence, EKG performed at every visit, and interrogation of implanted device or ILR when applicable. Results Enrollment began in January 2018 with a single site. Additional sites began enrollment in October 2019. Through May 2021, 1,243 patients underwent 1,269 procedures at 13 institutions. Our goal is to enroll 4000 patients. Discussion Real-AF’s multiple data sources and detailed procedural information, emphasis on high volume operators, inclusion of low fluoroscopy operators, and use of rigorous standardized follow-up methodology allow systematic documentation of clinical outcomes associated with changes in ablation workflow and technologies over time. Timely data sharing may enable real-time quality improvements in patient care and delivery. Trial registration Clinicaltrials.gov: NCT04088071 (registration date: September 12, 2019) Supplementary Information The online version contains supplementary material available at 10.1007/s10840-021-01031-w.

Increasing awareness of the health risks associated with the exposure of patients and staff in the catheterization laboratory to radiation has encouraged the pursuit of efforts to reduce the use of fluoroscopy during catheter ablation procedures. Although nonfluoroscopic guidance of ablation catheters has been previously described, transseptal access is still perceived as the last remaining barrier to completely fluoroless ablations. This study examined the safety and effectiveness of transseptal puncture and radiofrequency (RF) catheter ablation using a completely fluoroless approach. Three hundred eighty-two consecutive cases that had undergone completely nonfluoroscopic RF catheter ablation were evaluated. Ablation procedures were performed for atrial fibrillation, atrial flutter, atrioventricular reentry tachycardia, and pulmonary vein complex/ventricular tachycardia. Transseptal puncture and RF ablation were conducted under three-dimensional electroanatomic mapping and intracardiac echocardiography image guidance. Fluoroless transseptal puncture and catheter ablation were completed successfully in all cases, with no intraoperative complications. One patient required minimal use of fluoroscopy to visualize sheath advancement through an existing inferior vena cava filter. Procedural time was approximately 2.2 hours from transvenous access until case conclusion; transseptal access was obtained within 28 minutes of procedure initiation. Arrhythmia was found to recur in 27% of cases on average three months after the procedure. We demonstrate the safety and effectiveness of a completely fluoroless transseptal puncture and RF ablation technique that eliminates radiation exposure and enables complex electrophysiology procedures to be performed in a lead-free environment.

Fracture of mandible can be classified according to its anatomical location, in which condylar fracture is the most common one overall and is missed on clinical examination. Due to the unique geometry of the mandible and temporomandibular joint, without treatment the fractures can result in marked pain, dysfunction, and deformity. The condylar fracture may be further classified depending on the sides involved: unilateral/bilateral, depending on the height of fracture: intracapsular (within the head of condyle), extracapsular - head and neck (high condyle fracture), and subcondylar (low condyle fracture), and depending on displacement: nondisplaced, displaced (anteromedially, medially, and lateral), and dislocated. The clinical features include swelling and tenderness over the temporomandibular joint region, restricted mouth opening, and anterior open bite. A 34-year-old male patient reported to the Department of Oral and Maxillofacial Surgery at Madha Dental College and Hospital; suffered fall trauma resulting in bilateral condyle fracture, dentoalveolar fracture in mandible with restricted mouth opening, and anterior open bite.

Background Atrial flutter (AFL) is commonly treated by radiofrequency catheter ablation. Catheter-based cryoablation may be an effective alternative with potential advantages. Objective The purpose of this study was to study the acute and long-term safety and efficacy of catheter-based cryoablation for treatment of cavotricuspid isthmus–dependent (typical and reverse typical) AFL. Methods Catheter-based cryoablation was performed with a 10Fr catheter in 160 patients with cavotricuspid isthmus–dependent AFL (122 men and 38 women; mean age 63.1 ± 9.3 years, mean left ventricular ejection fraction 54.6% ± 10.4%); 94 (58.8%) of these patients also had atrial fibrillation (AF). All patients underwent right atrial (RA) activation mapping and pacing at the cavotricuspid isthmus to demonstrate concealed entrainment and confirm cavotricuspid isthmus dependence of AFL. Catheter-based cryoablation of the cavotricuspid isthmus was performed with multiple freezes (average freeze time 2.3 ± 0.5 minutes) until bidirectional block was demonstrated during pacing from the low lateral RA and coronary sinus, respectively. Patients were evaluated at 1, 3, and 6 months and underwent weekly and symptomatic event monitoring. Acute procedural success was defined as cavotricuspid isthmus block persisting 30 minutes after ablation. Long-term success was defined as absence of AFL during follow-up. Results Acute success was achieved in 140 (87.5%) of 160 patients. Total procedure time was 200 ± 71 minutes, ablation time (including a 30-minute waiting period after ablation) was 139 ± 62 minutes, and fluoroscopy time was 35 ± 26 minutes. An average of 20.5 ± 11.3 freezes, for a total ablation time of 47.4 ± 24.3 minutes, were required to achieve cavotricuspid isthmus block, with average and nadir temperatures of −81.5°C ± 3.7°C and −85.6° ± 3.6°C, respectively. Four patients (2.5%) had procedure-related adverse events. Of 132 patients with acute efficacy who completed 6-month follow-up, 8 (6%) were lost to follow-up or were noncompliant with event recordings. Using survival analysis, 106 (80.3%) remained free of AFL on strict analysis of event recordings only, and 119 (90.2%) remained clinically free of AFL. Conclusion This large pivotal study demonstrated the acute and long-term efficacy and safety of catheter-based cryoablation for cavotricuspid isthmus–dependent AFL, similar to rates previously reported for radiofrequency catheter ablation.

Background and objectives The primary goal of periodontal therapy is to restore the tooth supporting tissues lost due to periodontal disease. The aim of the present study was to compare the efficacy of combination of GTR membrane and alloplastc bone graft with open flap debridement (OFD) in treatment of periodontal intrabony defects. Methods Twenty paired intrabony defects were surgically treated using split mouth design. The defects were randomly assigned to treatment with OFD, GTR membrane + bone graft (test) or OFD alone (control). The clinical efficacy of two treatment modalities was evaluated at 6 months postoperatively by clinical, radiographical parameters. The measurements included probing pocket depth (PD), clinical attachment level (CAL), gingival recession (GR), bone fill (BF), bone density (BD). Results The mean reduction in PD at 0 to 6 months was 3.20 ± 0.82 mm and CAL gain of 3.10 ± 1.51 mm occurred in the GTR membrane + bone graft (test) group; corresponding values for OFD (control) were 2.10 ± 0.63 mm and 1.90 ± 0.57 mm. Similar pattern of improvement was observed when radiographically postoperative evaluation was made. All improvement in different parameters was statistically significant (p < 0.01). Conclusion Treatment with a combination of collagen membrane and bone graft led to a significantly more favorable clinical outcome in intrabony defects as compared to open flap debridement alone. How to cite this article Mopur JM, Devi TR, Ali SM, Srinivasa TS, Gopinath V, Salam ART. Clinical and Radiographic Evaluation of Regenerative Potential of GTR Membrane (Biomesh®) along with Alloplastic Bone Graft (Biograft®) in the Treatment of Periodontal Intrabony Defects. J Contemp Dent Pract 2013;14(3):434-439.