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Importance: Complete hardware removal is a class I recommendation for cardiovascular implantable electronic device (CIED) infection, but practice patterns and outcomes remain unknown., Objective: To quantify the number of Medicare patients with CIED infections who underwent implantation from 2006 to 2019 and lead extraction from 2007 to 2019 to analyze the outcomes in these patients in a nationwide clinical practice cohort., Design, Setting, and Participants: This cohort study included fee-for-service Medicare Part D beneficiaries from January 1, 2006, to December 31, 2019, who had a de novo CIED implantation and a CIED infection more than 1 year after implantation. Data were analyzed from January 1, 2005, to December 31, 2019., Exposure: A CIED infection, defined as (1) endocarditis or infection of a device implant and (2) documented antibiotic therapy., Main Outcomes and Measures: The primary outcomes of interest were device infection, device extraction, and all-cause mortality. Time-varying multivariable Cox proportional hazards regression models were used to evaluate the association between extraction and survival., Results: Among 1 065 549 patients (median age, 78.0 years [IQR, 72.0-84.0 years]; 50.9% male), mean (SD) follow-up was 4.6 (2.9) years after implantation. There were 11 304 patients (1.1%) with CIED infection (median age, 75.0 years [IQR, 67.0-82.0 years]); 60.1% were male, and 7724 (68.3%) had diabetes. A total of 2102 patients with CIED infection (18.6%) underwent extraction within 30 days of diagnosis. Infection occurred a mean (SD) of 3.7 (2.4) years after implantation, and 1-year survival was 68.3%. There was evidence of highly selective treatment, as most patients did not have extraction within 30 days of diagnosed infection (9202 [81.4%]), while 1511 (13.4%) had extraction within 6 days of diagnosis and 591 (5.2%) had extraction between days 7 and 30. Any extraction was associated with lower mortality compared with no extraction (adjusted hazard ratio [AHR], 0.82; 95% CI, 0.74-0.90; P < .001). Extraction within 6 days was associated with even lower risk of mortality (AHR, 0.69; 95% CI, 0.61-0.78; P < .001)., Conclusions and Relevance: In this study, a minority of patients with CIED infection underwent extraction. Extraction was associated with a lower risk of death compared with no extraction. The findings suggest a need to improve adherence to guideline-directed care among patients with CIED infection.

Background: The rate of cardiovascular implantable electronic device infections (CIEDIs) has mirrored or exceeded the increased use of implantable cardiac devices in the United States. The presence of racial and ethnic disparities associated with CIEDIs has not been published. Our aim is to describe the presence of racial and ethnic disparities with respect to the management of CIEDIs., Methods: We reviewed a prospective single-center registry for patients undergoing removal of an implantable cardiac device between 1/2004 and 1/2016. 1173 consecutive patients underwent device extraction. 699 patients were identified as having an infection, 305 were identified as Caucasian and 394 were minorities (91 African Americans, 303 Hispanics). Patients had pre-operative transesophageal echocardiograms (TEEs) and collection of blood and exudate cultures. All underwent complete hardware extraction; leads were removed through the use of locking stylets and traction or laser extraction. En-bloc capsulectomy was performed with intraoperative specimen collection from pocket tissue, exudate, lead tips, and vegetations., Results: Minority patients were: younger (67.9 ± 14.5 years vs 72.4 ± 13.2 years), had a higher proportion of male gender, diabetes, and chronic renal failure (p < 0.001). Minorities experienced a higher rate of complications during extraction and a longer hospitalization (15.3 ± 9.9 days versus 17.4 ± 13.4 days, p < 0.001). There was no significant difference between the proportion of types of infection in both groups., Conclusion: Minority patients with CIEDIs experienced more procedural complications during extraction and had a significantly longer length of index hospitalization than Caucasian patients., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: We examined the outcomes of older adults undergoing nontrans-femoral (non-TF) transcatheter aortic valve replacement (TAVR) procedures including trans-apical (TA), trans-aortic (TAo), trans-subclavian (TSub), and trans-carotid (TCa) techniques., Methods and Results: This is an observational study of all consecutive older patients who underwent non-TF TAVR for symptomatic severe AS with Edwards Sapien (ES), Medtronic CoreValve, ES3 or Lotus Valve at three centers in France and the United States from 04/2008 to 02/2017. Baseline characteristics and clinical outcomes were defined according to VARC-2 criteria. Of 857 patients who received TAVR, 172 (20%) had an alternative access procedure. Of these, 45 (26%) were TA, 67 (39%) TAo, 17 (10%) TSub, and 43 (25%) TCa procedures. The preference for non-TF access site was different between the two countries (US: TA 39%, TAo 52%, TSub 9%; TCa 0% vs. France: TA 9%, TAo 23%, TSub 11%, and TCa 57%, P-value < .001). Most patients who underwent TAo TAVR were older women (median age: TA 82, TAo 84, TSub 81, TCa 81, P-value = 0.043; female gender: TA 32 (27%), TAo 30 (55%), TSub 10 (41%), TCa 27 (37%), P-value = .021). The predicted Society of Thoracic Surgery risk of mortality was similar among groups (TA 7%, TAo 7%, TSub 6%, TCa 7%, P-value= .738). No differences were observed in the frequency of para-valvular leak, intra-procedural bleeding, vascular complications, conversion to open-heart surgery, or development of acute kidney injury. The highest in-hospital mortality was observed in the TAo group (TA 2%, TAo 15%, TSub 0%, TCa 2%, P-value = .014). However, hospital length of stay, one-month, and one-year mortality were similar among non-TF techniques., Conclusion: Although regional differences exist in the choice of alternative access techniques, centers with high technical expertise can provide a safe alternative to traditional TF TAVR. TAo TAVR was associated with higher in-hospital mortality than other non-TF approaches, and this may have reflected patient rather than procedural factors. All alternative access techniques had similar mortality rates and clinical outcomes at one-year follow-up. Trans-carotid access is safe and feasible compared to other non-TF access techniques., (© 2018 Wiley Periodicals, Inc.)

Background: Prevention of sudden cardiac arrest (SCA) after removal of an infected implantable cardioverter-defibrillator (ICD) is a challenging clinical dilemma. The cost-effectiveness of the wearable cardioverter-defibrillator (WCD) in this setting remains uncertain., Objective: The purpose of this study was to compare the cost-effectiveness of the WCD with discharge home, discharge to a skilled nursing facility, or inpatient monitoring for the prevention of SCA after infected ICD removal., Methods: A decision model was developed to compare the cost-effectiveness of use of the WCD to several different strategies for patients who undergo ICD removal. One-way and 2-way sensitivity analyses were performed to account for uncertainties., Results: In the base-case analysis, the incremental cost-effectiveness of the WCD strategy was $20,300 per life-year (LY) or $26,436 per quality-adjusted life-year (QALY) compared to discharge home without a WCD. Discharge to a skilled nursing facility and in-hospital monitoring resulted in higher costs and worse clinical outcomes. The incremental cost-effectiveness ratio was as low as $15,392/QALY if the WCD successfully terminated 95% of SCA events and exceeded the $50,000/QALY willingness-to-pay threshold if the efficacy was <69%.The WCD strategy remained cost-effective, assuming 5.6% 2-month SCA risk, as long as the time to reimplantation was at least 2 weeks., Conclusion: The WCD likely is cost-effective in protecting patients against SCA after infected ICD removal while waiting for ICD reimplantation compared to keeping patients in the hospital or discharging them home or to a skilled nursing facility., (Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

While hemodialysis access ligation has been used to manage pacemaker (PM) and implantable cardioverter-defibrillator (ICD) lead-induced central venous stenosis (CVS), percutaneous transluminal balloon angioplasty (PTA) has also been employed to manage this complication. The advantages of PTA include minimal invasiveness and preservation of arteriovenous access for hemodialysis therapy. In this multi-center study we report the patency rates for PTA to manage lead-induced CVS. Consecutive PM/ICD chronic hemodialysis patients with an arteriovenous access referred for signs and symptoms of CVS due to lead-induced CVS were included in this analysis. PTA was performed using the standard technique. Technical and clinical success was examined. Technical success was defined as the ability to successfully perform the procedure. Clinical success was defined as the ability to achieve amelioration of the signs and symptoms of CVS. Both primary and secondary patency rates were also analyzed. Twenty-eight consecutive patients underwent PTA procedure. Technical success was 95%. Postprocedure clinical success was achieved in 100% of the cases where the procedure was successful. The primary patency rates were 18% and 9% at 6 and 12 months, respectively. The secondary patency rates were 95%, 86%, and 73% at 6, 12, and 24 months, respectively. On average, 2.1 procedures/year were required to maintain secondary patency. There were no procedure-related complications. This study finds PTA to be a viable option in the management of PM/ICD lead-induced CVS. Additional studies with appropriate design and sample size are required to conclusively establish the role of PTA in the management of this problem.