Randomized Trial of Stand-Alone Use of the Antimicrobial Envelope in High-Risk Cardiac Device Patients.

BACKGROUND: Cardiac implantable electronic device (CIED) infection has a high mortality. Previous investigations showed reduced postoperative infections using skin preparation with chlorhexidine, preoperative intravenous antibiotics, and a TYRX-a antibacterial envelope. The additional benefit of antibiotic pocket wash and postoperative antibiotics has not been systematically studied. METHODS: The ENVELOPE trial (A Randomized trial of Stand-Alone Use of the Antimicrobial Envelope in High-Risk Cardiac Device Patients) was a prospective, multicenter, randomized, controlled trial enrolling patients undergoing CIED procedures with ≥2 risk factors for infection. The control arm received standard chlorhexidine skin preparation, intravenous antibiotics, and the TYRX-a antibiotic envelope. The study arm received pocket wash (500 mL antibiotic solution) and postoperative antibiotics for 3 days along with the prophylactic control measures. The primary end point was CIED infection and system removal at 6 months. RESULTS: One thousand ten subjects (505 per arm) were enrolled and randomized. Patients were seen in person for a wound check with digital photo 2 weeks postimplant and at 3 and 6 months. CIED infection rate was low in both groups (1.0% control arm and 1.2% study arm, P=0.74). In the 11 subjects with infection and system removal, the time to study end point was 107±92 days with a PADIT (Prevention of Arrhythmia Device Infection Trial) score of 7.4 and a 64% 1-year mortality. Prior history of CIED infection independently predicted CIED system removal at 6 months in all subjects (odds ratio, 9.77, P=0.004). Of 11 infections requiring system removal, 5 were in the setting of pocket hematoma. CONCLUSIONS: The use of antibiotic pocket irrigation and postoperative oral antibiotics provides no additional benefit to the prophylactic measures of chlorhexidine skin preparation, preoperative intravenous antibiotics, and an antibiotic envelope in reducing CIED infection. Postoperative hematoma is a major risk factor for infection, driven by the use of antiplatelet and anticoagulant medications. The strongest predictor of CIED removal at 6 months, regardless of intervention, was prior CIED infection. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02809131.

Social Media in Physician Education.

Background Social media has fundamentally changed the practice of medicine. It has taken the medical community by storm, benefited patient care, and has become a leading source for distributing medical information. Social media platforms are a low-cost, low-barrier entry means for health systems to highlight their competitive advantage to patients and providers alike. This study aimed to assess the role of social media in the education of physicians. Methods To evaluate the utility of social media in engaging physicians, four vignettes were utilized to highlight Class 1 indications for transvenous lead extraction (TLE), an electrophysiology procedure aimed at removing infected or damaged cardiac device leads. Individuals, via Twitter, were presented with cases and multiple-choice response options to determine the next best step in management. Results The clinical vignettes were seen by more than 18,000 individuals worldwide. Survey results indicated that 83% of individuals who participated had correctly identified class 1 indications for this life-saving procedure. Sixteen percent to 21% of physicians incorrectly identified the next step in the management of Class 1 indications for lead extraction, representing a need for education and an opportunity to inform and educate. Conclusion Social media may be a useful tool in physician education. However, guidelines and further research are needed to continue to understand the role of social media within the medical field.

Virtual reality lead extraction as a method for training new physicians: a pilot study.

BACKGROUND: It is estimated that the demand for transvenous lead extraction (TLE) has reached an annual extraction rate of nearly 24,000 patients worldwide. Despite technologic advances, TLE still has the potential for significant morbidity and mortality. Complication rates with TLE directly parallel operator experience. However, obtaining adequate training during and postfellowship can be difficult. Given the potential for catastrophic complications and the steep learning curve (up to 300 cases) associated with this procedure, we sought to validate a virtual reality (VR) lead extraction simulator as an innovative training and evaluation tool for physicians new to TLE. METHODS: We randomized eight electrophysiology fellows to VR simulator versus conventional training. We compared procedural skill competency between the groups using simulator competency, tactile measurements, markers of proficiency and attitudes, and cognitive abilities battery. RESULTS: Practical skills and simulator complications differed significantly between the VR simulator and conventional training groups. The VR simulator group executed patient preparation and procedure performance better than the conventional group (P < 0.01). All four fellows randomized to conventional training experienced a simulator complication (two superior vena cava [SVC] tears, three right ventricle [RV] avulsions) versus one fellow in the VR simulator group (one SVC tear) (P = 0.02). Tactile measurements revealed a trend toward excess pushing versus pulling forces among the conventionally trained group. The time for lead removal was also significantly higher in the conventional training group (12.46 minutes vs 5.54 minutes, P = 0.02). There was no significant difference in baseline or posttraining cognitive ability. CONCLUSIONS: We contend that the implementation of alternative training tools such as a VR simulation model will improve physician training and allow for an innovative pathway to assess the achievement of competency.

The transaortic approach for transcatheter aortic valve replacement: initial clinical experience in the United States.

OBJECTIVES: This study sought to investigate the technical feasibility and safety of the transaortic (TAO) transcatheter aortic valve replacement (TAVR) approach in patients not eligible for transfemoral (TF) access by using a device commercially available in the United States. BACKGROUND: A large proportion of candidates for TAVR have inadequate iliofemoral vessels for TF access. The transapical route (TAP) is the current alternative but is associated with less favorable outcomes. Other access options need to be explored. METHODS: Forty-four consecutive patients with inoperable, severe aortic stenosis underwent TAO TAVR in our institution. Procedural and 30-day clinical outcomes data were compared with data from 76 consecutive patients who underwent TAP TAVR at our site. Technical learning curves were assessed by comparing outcomes of the first 20 cases with the subsequent patients who underwent each procedure. RESULTS: The TAO and TAP TAVR groups were similar in terms of device success according to Valve Academic Research Consortium criteria (89% vs. 84%; p = 0.59) and rates of the 30-day combined safety endpoint of all-cause mortality, myocardial infarction, major stroke, disabling bleeding, severe acute kidney injury, and valve reintervention (20% vs. 33%; p = 0.21). The TAO approach, compared with TAP TAVR, was associated with lower combined bleeding and vascular event rate (27% vs. 46%; p = 0.05), shorter median intensive care unit length of stay (3 vs. 6 days; p = 0.01), and a favorable learning curve. CONCLUSIONS: TAVR via the TAO approach is technically feasible, seems to be associated with favorable outcomes, and expands the current alternative options for access sites in patients with inoperable aortic stenosis who are ineligible for TF TAVR.