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Background: Superior vena cava (SVC) tears are one of the most lethal complications in transvenous lead extraction. An endovascular balloon can occlude the SVC in the event of a laceration, preventing blood loss and offering a more controlled surgical field for repair. An early study demonstrated that proper use of this device is associated with reduced mortality. Thereafter, high-volume extractors at the Eleventh Annual Lead Management Symposium developed a best practice protocol for the endovascular balloon., Methods: We collected data on adverse events in lead extraction from July 1, 2016, to July 31, 2018. Data were prospectively collected from both a US Food and Drug Administration-maintained database and physician reports of adverse events as they occurred. We gathered case details directly from extracting physicians. Confirmed SVC tears were analyzed for patient demographics, case details, and index hospitalization mortality., Results: From July 1, 2016, to July 31, 2018, 116 confirmed SVC events were identified, of which 44.0% involved proper balloon use and 56.0% involved no use or improper use. When an endovascular balloon was properly used, 45 of 51 patients (88.2%) survived in comparison to 37 of 65 patients (56.9%) when a balloon was not used or improperly used (P=0.0002). Furthermore, multivariate regression modeling found that proper balloon deployment was an independent, negative predictor of in-hospital mortality for patients who experienced an SVC laceration (odds ratio, 0.13; 95% CI, 0.04-0.40; P<0.001)., Conclusions: From July 1, 2016, through July 31, 2018, patients undergoing lead extraction were more likely to survive SVC tears when treatment included an endovascular balloon.

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: Superior vena cava (SVC) lacerations have been identified as the most lethal complication encountered during cardiac implantable electronic device lead extraction. The case fatality rate of these events approximates 50% due to rapid exsanguination. A novel, compliant balloon specifically designed for use in the SVC may provide hemostasis in the event of endovascular perforation. By temporarily occluding the compromised vessel, the endovascular balloon should delay hemodynamic collapse, provide a more controlled surgical field for repair, and thereby reduce the mortality of SVC tears complicating transvenous lead extraction., Objective: To assess the early impact of the compliant endovascular balloon on the management of SVC tears and survival outcomes., Methods: We searched a publicly available, United States Food and Drug Administration-maintained database for adverse events from 1 manufacturer of lead extraction tools. Reports from July 1, 2016, to December 31, 2016 were reviewed by 2 physicians to identify instances of SVC tears. Extracting physicians were contacted for further case details. Confirmed SVC tears were analyzed for patient demographics, repair strategies, and index hospitalization mortality., Results: Of the complications reported, 35 cases of surgically confirmed SVC tears were identified. One hundred percent of patients (9/9) were discharged alive when the endovascular balloon was properly utilized, compared to 50% of patients (13/26) when the device was not used (P = .0131). Differences between all other variables analyzed were statistically insignificant., Conclusion: During the study period, we observed a reduction in mortality in patients who suffered SVC tears while undergoing lead extraction when treatment included an endovascular balloon., (Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: A higher frequency Excimer laser sheath using an 80-Hz pulse repetitive rate was approved by the Food and Drug Administration in April 2012. We reported our initial clinical experience with a high-frequency Excimer laser sheath and compared it with lower-frequency laser sheaths which have been previously used., Methods: In this single center, retrospective cohort study, we evaluated patients who underwent lead extraction from December 2008 to May 2013. Those who underwent lead removal without using a laser sheath or with approaches other than subclavian were excluded. Primary endpoints included total laser time, number of pulses, and complications. Data on clinical characteristics, lead type, indications, and outcomes were prospectively collected and analyzed., Results: A total of 427 patients were included in the study (72.6% male; age 67.9 ± 15.23 years). Lower frequency and higher frequency laser sheaths were used in 315 and 112 patients, respectively. A total of 821 leads were removed with 765 leads (93.2%) extracted using the Excimer laser sheath. Lead age was 5.71 ± 4.96 years. Complete extraction was seen in all patients. A higher-frequency laser sheath was associated with a lower laser time and a lower total number of laser pulses even after adjustments for the number of leads, type of leads, and lead age. In the higher frequency group, mortality rate was 0.9% and minor complication rate was 3.6%., Conclusions: When compared with the lower-frequency laser sheath, the higher-frequency laser sheath requires less laser times and more efficient amount of pulses for lead extraction with comparable success rate. Due to the rarity of major and minor complications, no statistical significance was found between the two groups., (©2014 Wiley Periodicals, Inc.)

Objectives: The purpose of this study was to determine whether the clinical presentation of lead-associated endocarditis (LAE) is related to the size of lead vegetations and how size is related to bacteriology and clinical outcomes., Background: Cardiac implantable electronic device (CIED) infection may present as either local pocket infection or bloodstream infection with or without LAE. LAE is associated with significant morbidity and mortality., Methods: The clinical presentation and course of LAE were evaluated by the MEDIC (Multicenter Electrophysiologic Device Cohort) registry, an international registry enrolling patients with CIED infection. Consecutive LAE patients enrolled in the MEDIC registry between January 1, 2009 and December 31, 2012 were analyzed. The clinical features and outcomes of 2 groups of patients were compared based on the size of the lead vegetation detected by echocardiography (> or <1 cm in diameter)., Results: There were 129 patients with LAE enrolled into the MEDIC registry. Of these, 61 patients had a vegetation <1 cm in diameter (Group I) whereas 68 patients had a vegetation ≥1 cm in diameter (Group II). Patients in Group I more often presented with signs of local pocket infection, whereas Group II patients presented with clinical evidence of systemic infection. Staphylococcus aureus was the organism most often responsible for LAE, whereas infection with coagulase-negative staphylococci was associated with larger vegetations. Outcomes were improved among those who underwent complete device removal. However, major complications were associated with an open surgical approach for device removal., Conclusions: The clinical presentation of LAE is influenced by the size of the lead vegetation. Prompt recognition and management of LAE depends on obtaining blood cultures and echocardiography, including transesophageal echocardiography, in CIED patients who present with either signs of local pocket or systemic infection., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The use of laser lead extraction (LLE) to remove pacemaker and implantable cardiac defibrillator leads has become more prevalent in the past decade. Though the procedure is associated with a low rate of complications, LLE still poses some risks to patients. Some reports have suggested an increase in tricuspid insufficiency (TI) associated with LLE. We present a series of patients who underwent both LLE and complete evaluation for TI with echocardiographic techniques., Methods: From August 2008 to January 2010, 173 prospective, consecutive patients underwent LLE in a single center. All patients had transesophageal echocardiograms (TEE) during the extraction. Fifty-three patients had tricuspid valve function evaluated a day before the procedure with a transthoracic echocardiogram (TTE), during the procedure with a TEE and 2 days postoperatively with a TTE., Results: All 173 patients experienced no change in tricuspid valve function during the procedure with TEE. Of the 53 patients who underwent a complete TI evaluation, 38 were males (72%) and 15 females (38%), with a mean age of 69.45 ± 14.08. Mean ejection fraction was 35.82 ± 14.72. Three (6%) patients experienced TI after the procedure (two mild and one severe, all with tricuspid valve endocarditis); 16 (30%) patients were found to have TI before LLE that returned to normal valve function during or after the procedure. Thirty-four (64%) patients did not experience any significant change of the tricuspid valve performance after LLE., Conclusion: LLE was not associated with increased TI., (©2013, The Authors. Journal compilation ©2013 Wiley Periodicals, Inc.)

Background/objective: Active fixation coronary sinus (CS) leads limit dislodgement and represent an attractive option to the implanter. Although extraction of passive fixation CS leads is a common and frequently uncomplicated procedure, data regarding extraction of chronically implanted active fixation CS leads are limited., Methods: We performed a retrospective cohort study of patients undergoing active fixation CS lead extraction at six centers. Patient and procedural characteristics, indications for extraction, use of extraction sheath (ES) assistance, and outcomes are reported., Results: Between January 2009 and February 2011, 12 patients underwent transvenous lead extraction (TLE) of Medtronic StarFix® lead (Medtronic Inc., Minneapolis, MN, USA). The cohort was 83% male with mean age 71 ± 14 years. Average implant duration was 14.2 ± 5.7 months (2.3-23.6). All leads but one were removed for infectious indications (67% systemic infection). At the time of explant, the fixation lobes were completely retracted in only one of the 12 cases and ES assistance was required for lead removal in all cases (58% laser, 25% cutting, 25% mechanical, and 25% femoral). The majority of cases required advancement of the sheath into the CS (75.0%) and often into a branch vessel (41.7%). One lead could not be removed transvenously and required surgical lead extraction. There were no major complications. Examination of the leads after extraction frequently revealed significant tissue growth into the fixation lobes., Conclusions: Although TLE of active fixation CS leads can be a safe procedure in select patients and experienced hands, powered sheaths and aggressive techniques are frequently required for successful removal despite relatively short implant durations. This raises significant concern regarding future TLE of active fixation CS leads with longer implant durations., (©2012, The Authors. Journal compilation ©2012 Wiley Periodicals, Inc.)

Background: The use of percutaneous lead extraction techniques in a patient with extracardiac or protruding atrial leads could have disastrous consequences. Traditionally, the management of these patients has included a median sternotomy. We describe a minimally invasive technique that involves a transatrial, retrograde laser lead extraction using a video-assisted thoracoscopic approach., Methods and Results: Between January 2004 and June 2009, 14 patients with severed leads at the clavicle and extracardiac leads or lead-caused erosions of the atrial wall were identified through chest radiograph and CT scan. There were 9 men and 5 women aged 19 to 91 years (mean age, 69.71 ± 20.67 years). Ten devices were pacemakers, and 4 were defibrillators. Indications for extraction were 12 infections and 2 malfunctions. Mean ejection fraction was 42 ± 17.67% (range, 10% to 65%). Time of implanted leads was 93.69 ± 51.88 months (range, 33 to 213 months). Laser sheaths size were 12 F (7.1%), 14 F (85.7%), and 16 F (7.1%). A right-side thoracoscopy was performed under general anesthesia. A retrograde laser sheath maneuver was performed, freeing the lead from any adhesions. The lead was removed and the incision closed. One patient experienced a pleural effusion. There was no mortality, and all patients were alive and well at 1-month follow-up., Conclusions: - Transatrial, retrograde laser lead extraction is a safe and effective procedure. This procedure may provide an excellent alternative to open sternotomy.