Efficacy and Safety of an Extravascular Implantable Cardioverter-Defibrillator.

BACKGROUND: The extravascular implantable cardioverter-defibrillator (ICD) has a single lead implanted substernally to enable pause-prevention pacing, antitachycardia pacing, and defibrillation energy similar to that of transvenous ICDs. The safety and efficacy of extravascular ICDs are not yet known. METHODS: We conducted a prospective, single-group, nonrandomized, premarket global clinical study involving patients with a class I or IIa indication for an ICD, all of whom received an extravascular ICD system. The primary efficacy end point was successful defibrillation at implantation. The efficacy objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients with successful defibrillation was greater than 88%. The primary safety end point was freedom from major system- or procedure-related complications at 6 months. The safety objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients free from such complications was greater than 79%. RESULTS: A total of 356 patients were enrolled, 316 of whom had an implantation attempt. Among the 302 patients in whom ventricular arrhythmia could be induced and who completed the defibrillation testing protocol, the percentage of patients with successful defibrillation was 98.7% (lower boundary of the one-sided 97.5% confidence interval [CI], 96.6%; P<0.001 for the comparison with the performance goal of 88%); 299 of 316 patients (94.6%) were discharged with a working ICD system. The Kaplan-Meier estimate of the percentage of patients free from major system- or procedure-related complications at 6 months was 92.6% (lower boundary of the one-sided 97.5% CI, 89.0%; P<0.001 for the comparison with the performance goal of 79%). No major intraprocedural complications were reported. At 6 months, 25 major complications were observed, in 23 of 316 patients (7.3%). The success rate of antitachycardia pacing, as assessed with generalized estimating equations, was 50.8% (95% CI, 23.3 to 77.8). A total of 29 patients received 118 inappropriate shocks for 81 arrhythmic episodes. Eight systems were explanted without extravascular ICD replacement over the 10.6-month mean follow-up period. CONCLUSIONS: In this prospective global study, we found that extravascular ICDs were implanted safely and were able to detect and terminate induced ventricular arrhythmias at the time of implantation. (Funded by Medtronic; ClinicalTrials.gov number, NCT04060680.).

18F-FDG PET/CT and radiolabeled leukocyte SPECT/CT imaging for the evaluation of cardiovascular infection in the multimodality context: ASNC Imaging Indications (ASNC I2) Series Expert Consensus Recommendations from ASNC, AATS, ACC, AHA, ASE, EANM, HRS, IDSA, SCCT, SNMMI, and STS.

This document on cardiovascular infection, including infective endocarditis, is the first in the American Society of Nuclear Cardiology Imaging Indications (ASNC I2) series to assess the role of radionuclide imaging in the multimodality context for the evaluation of complex systemic diseases with multi-societal involvement including pertinent disciplines. A rigorous modified Delphi approach was used to determine consensus clinical indications, diagnostic criteria, and an algorithmic approach to diagnosis of cardiovascular infection including infective endocarditis. Cardiovascular infection incidence is increasing and is associated with high morbidity and mortality. Current strategies based on clinical criteria and an initial echocardiographic imaging approach are effective but often insufficient in complicated cardiovascular infection. Radionuclide imaging with 18F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) and single photon emission computed tomography/CT leukocyte scintigraphy can enhance the evaluation of suspected cardiovascular infection by increasing diagnostic accuracy, identifying extracardiac involvement, and assessing cardiac implanted device pockets, leads, and all portions of ventricular assist devices. This advanced imaging can aid in key medical and surgical considerations. Consensus diagnostic features include focal/multi-focal or diffuse heterogenous intense 18F-FDG uptake on valvular and prosthetic material, perivalvular areas, device pockets and leads, and ventricular assist device hardware persisting on non-attenuation corrected images. There are numerous clinical indications with a larger role in prosthetic valves, and cardiac devices particularly with possible infective endocarditis or in the setting of prior equivocal or non-diagnostic imaging. Illustrative cases incorporating these consensus recommendations provide additional clarification. Future research is necessary to refine application of these advanced imaging tools for surgical planning, to identify treatment response, and more.

The clinical and economic impact of extended battery longevity of a substernal extravascular implantable cardioverter defibrillator.

INTRODUCTION: The extravascular implantable cardioverter defibrillator (EV ICD) has extended projected battery longevity compared to the subcutaneous implantable cardioverter defibrillator (S-ICD). This study used modeling to characterize the need for generator changes, long-term complications, and overall costs for both the EV ICD and S-ICD in healthcare systems of various countries. METHODS: Battery longevity data were modeled using a Markov model from averages reported in device labeling for the S-ICD and with engineering estimates based on real life usage from EV ICD Pivotal Study patient data to introduce variability. Clinical demographic data were derived from published literature. The primary outcomes were defined as the number of generator replacement surgeries, complications, and total healthcare system costs due to battery depletion over the expected lifetime of patients receiving EV ICD or S-ICD therapy. RESULTS: Average modeled battery longevity was determined to be 7.3 years for the S-ICD versus 11.8 years for the EV ICD. The probability of a complication after a replacement procedure was 1.4%, with an operative mortality rate of 0.02%. The use of EV ICD was associated with 1.4-1.6 fewer replacements on average over an expected patient lifetime as compared to S-ICD and a 24.3%-26.0% reduction in cost. A one-way sensitivity analysis of the model for the US healthcare system found that use of an EV ICD resulted in a reduction in replacement surgeries of greater than 1 (1.1-1.6) along with five-figure cost savings in all scenarios ($18 602-$40 948). CONCLUSION: The longer projected battery life of the EV ICD has the potential to meaningfully reduce long-term morbidity and healthcare resources related to generator changes from the perspective of multiple diverse healthcare systems.

Patient-reported quality of life and acceptance of the extravascular implantable cardioverter-defibrillator: Results from pivotal study.

INTRODUCTION: The pivotal study of the extravascular implantable cardioverter-defibrillator (EV ICD) recently demonstrated primary efficacy and safety endpoints comparable to previous ICD systems. Patient experience with this novel device has not been reported. The current study examined the standardized patient-reported outcome (PRO) metrics of quality of life (QOL) and patient acceptance of the device. METHODS: The EV ICD Pivotal Study was a prospective, single-arm, nonrandomized, global, premarket approval trial. Patients completed the 12-Item Short Form Survey (SF-12) QOL surveys at baseline and at 6 months following implant. Additionally, patients completed the Florida Patient Acceptance Survey (FPAS) QOL survey at 6 months. RESULTS: From baseline to 6 months, patients within the EV ICD Pivotal Study (n = 247) reported statistically significant SF-12 improvements in physical QOL (45.4 ± 9.4 vs. 46.8 ± 9.1 respectively, p = .020) and no changes in mental QOL (49.3 ± 10.4 vs. 50.5 ± 9.7, p = .061). No differences were noted by sex, atrial fibrillation, or the experience of ICD shock. EV ICD patients reported better total FPAS patient acceptance of their ICD than TV-ICD or S-ICD patients using historical norms comparisons (80.4 ± 15.7 vs. 70.2 ± 17.8, p < .0001 for S-ICD and 73.0 ± 17.4, p = .004 for TV-ICD). CONCLUSION: The initial PROs for EV ICD patients indicated that patients had improvements in physical QOL from baseline to 6-month follow-up and markedly better overall acceptance of their ICD compared to a previous study with S-ICD and TV-ICD data. These initial results suggest that the EV ICD is evaluated positively by patients.

Arrhythmias in Female Patients: Incidence, Presentation and Management.

There is a growing appreciation for differences in epidemiology, treatment, and outcomes of cardiovascular conditions by sex. Historically, cardiovascular clinical trials have under-represented females, but findings have nonetheless been applied to clinical care in a sex-agnostic manner. Thus, much of the collective knowledge about sex-specific cardiovascular outcomes result from post hoc and secondary analyses. In some cases, these investigations have revealed important sex-based differences with implications for optimizing care for female patients with arrhythmias. This review explores the available evidence related to cardiac arrhythmia care among females, with emphasis on areas in which important sex differences are known or suggested. Considerations related to improving female enrollment in clinical trials as a way to establish more robust clinical evidence for the treatment of females are discussed. Areas of remaining evidence gaps are provided, and recommendations for areas of future research and specific action items are suggested. The overarching goal is to improve appreciation for sex-based differences in cardiac arrhythmia care as 1 component of a comprehensive plan to optimize arrhythmia care for all patients.

18F-FDG PET/CT and radiolabeled leukocyte SPECT/CT imaging for the evaluation of cardiovascular infection in the multimodality context: ASNC Imaging Indications (ASNC I2) Series Expert Consensus Recommendations from ASNC, AATS, ACC, AHA, ASE, EANM, HRS, IDSA, SCCT, SNMMI, and STS.

This document on cardiovascular infection, including infective endocarditis, is the first in the American Society of Nuclear Cardiology Imaging Indications (ASNC I2) series to assess the role of radionuclide imaging in the multimodality context for the evaluation of complex systemic diseases with multi-societal involvement including pertinent disciplines. A rigorous modified Delphi approach was used to determine consensus clinical indications, diagnostic criteria, and an algorithmic approach to diagnosis of cardiovascular infection including infective endocarditis. Cardiovascular infection incidence is increasing and is associated with high morbidity and mortality. Current strategies based on clinical criteria and an initial echocardiographic imaging approach are effective but often insufficient in complicated cardiovascular infection. Radionuclide imaging with 18F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (CT) and single photon emission computed tomography/CT leukocyte scintigraphy can enhance the evaluation of suspected cardiovascular infection by increasing diagnostic accuracy, identifying extracardiac involvement, and assessing cardiac implanted device pockets, leads, and all portions of ventricular assist devices. This advanced imaging can aid in key medical and surgical considerations. Consensus diagnostic features include focal/multi-focal or diffuse heterogenous intense 18F-FDG uptake on valvular and prosthetic material, perivalvular areas, device pockets and leads, and ventricular assist device hardware persisting on non-attenuation corrected images. There are numerous clinical indications with a larger role in prosthetic valves, and cardiac devices particularly with possible infective endocarditis or in the setting of prior equivocal or non-diagnostic imaging. Illustrative cases incorporating these consensus recommendations provide additional clarification. Future research is necessary to refine application of these advanced imaging tools for surgical planning, to identify treatment response, and more.

Computed tomography predictors of increased transvenous lead extraction difficulty.

BACKGROUND: The ability of computed tomography (CT) characteristics to predict the difficulty of transvenous lead extraction (TLE) is an evolving subject. OBJECTIVE: To identify CT characteristics associated with increased TLE difficulty. METHODS: All consecutive patients undergoing TLE at the University of California San Diego from January 2018 to February 2022 were analyzed, utilizing the UC San Diego Lead Extraction Registry. Patients underwent cardiac-gated chest CT scans with intravenous contrast; all scans were reviewed by a single radiologist. Lead extraction was performed per standard institutional protocol with the initial use of a laser sheath and crossover to a mechanical sheath as needed. Multivariable linear and logistic regression analyses were performed to identify predictors of individual lead-removal fluoroscopy time and mechanical sheath use, as markers of extraction difficulty. RESULTS: A total of 343 patients were analyzed. The mean age of the study population was 63.8 ± 15.4 years; 71% were male. The mean lead dwell-in duration was 8.6 ± 5.7 years. In multivariable linear regression analysis, venous occlusion detected on CT was independently associated with higher individual lead-removal fluoroscopy time (p = 0.004), when adjusting for clinical characteristics such as lead dwell time. In multivariable logistic regression analysis, calcification and venous occlusion were independently associated with a higher need for mechanical sheath use during TLE (odds ratio:5.08, p < 0.001, 95% CI: 2.54-10.46) and (odds ratio:3.72, p < 0.001, 95% CI: 1.89-7.35), respectively. CONCLUSION: In patients undergoing TLE, venous occlusion identified by chest CT is associated with increased fluoroscopy time. Patients with lead-associated calcification or venous occlusion detected by chest CT are each five and three times more likely to require crossover from laser to a mechanical sheath.

A wearable cardioverter defibrillator with a low false alarm rate.

INTRODUCTION: 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. METHODS: 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). RESULTS: 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%). CONCLUSION: The ASSURE WCD demonstrated a low false-positive shock alarm rate, low patient-reported discomfort, and no serious adverse events.

Implantable loop recorder as a strategy following cardiovascular implantable electronic device extraction without reimplantation.

BACKGROUND: Limited data exists for outcomes in patients undergoing cardiovascular implantable electronic device (CIED) transvenous lead extraction (TLE) without clear indications for device reimplantation. The implantable loop recorder (ILR) may be an effective strategy for continuous monitoring in select individuals. OBJECTIVE: This retrospective analysis aims to investigate patients who have undergone ILR implant following TLE without CIED reimplantation. METHODS: Clinical data from consecutive patients who have undergone TLE with ILR implant and without CIED reimplantation from October 2016 to May 2020 at a single center were collected. RESULTS: Among 380 patients undergoing TLE, 28 (7.7%) underwent ILR placement without CIED reimplantation. TLE indications were systemic infection (n = 13, 46.4%), pain at the site (n = 8, 28.6%), device/lead malfunction (n = 4, 14.2%), and other. Devices extracted included: dual-chamber and single-chamber pacemaker (n = 14, 50%; n = 4, 14.2%), dual-chamber implantable cardiac defibrillator (n = 10; 35.7%), and cardiac-resynchronization therapy with defibrillator (n = 1, 3.5%). Reasons for no reimplantation included no longer meeting CIED criteria (n = 14, 50%), patient preference (n = 9, 32.1%), and no clear or inappropriate indication for initial CIED implantation (n = 5, 18%). During an average of 12.3 ± 13.1 months of follow-up, there were no lethal arrhythmias, and four (13.3%) patients underwent permanent pacemaker reimplantation due to symptomatic sinus bradycardia and atrioventricular block with syncope as discovered on ILR. Three patients died due to unknown causes (n = 1), noncardiac (n = 1), and acute coronary syndrome (n = 1). CONCLUSIONS: In patients undergoing TLE without reimplantation, an ILR may be an effective monitoring strategy in patients at low risk for cardiac arrhythmia.

The extravascular implantable cardioverter-defibrillator: The pivotal study plan.

BACKGROUND: Transvenous implantable cardioverter defibrillators (TV ICD) provide life-saving therapy for millions of patients worldwide. However, they are susceptible to several potential short- and long- term complications including cardiac perforation and pneumothorax, lead dislodgement, venous obstruction, and infection. The extravascular ICD system's novel design and substernal implant approach avoids the risks associated with TV ICDs while still providing pacing features and similar generator size to TV ICDs. STUDY DESIGN: The EV ICD pivotal study is a prospective, multicenter, single-arm, nonrandomized, premarket clinical study designed to examine the safety and acute efficacy of the system. This study will enroll up to 400 patients with a Class I or IIa indication for implantation of an ICD. Implanted subjects will be followed up to approximately 3.5 years, depending on when the patient is enrolled. OBJECTIVE: The clinical trial is designed to demonstrate safety and effectiveness of the EV ICD system in human use. The safety endpoint is freedom from major complications, while the efficacy endpoint is defibrillation success. Both endpoints will be assessed against prespecified criteria. Additionally, this study will evaluate antitachycardia pacing performance, electrical performance, extracardiac pacing sensation, asystole pacing, appropriate and inappropriate shocks, as well as a summary of adverse events. CONCLUSION: The EV ICD pivotal study is designed to provide clear evidence addressing the safety and efficacy performance of the EV ICD System.

Clinical significance of incidentally detected lead perforations by computed tomography.

BACKGROUND: Computed tomography (CT) has an established role in detecting perforation of implanted pacemaker and defibrillator leads. The clinical significance of incidental finding of delayed lead perforation remains unclear. The aim of this study was to assess the prevalence of lead perforation as detected by CT in a cohort of patients undergoing transvenous laser lead extraction and characterize the association between finding of incidental lead perforation with periprocedural outcomes. METHODS: Consecutive patients that underwent chest CT and lead extraction were retrospectively assessed for presence of lead perforation. A total of 143 patients and 348 leads were assessed. The finding of lead perforation was correlated with findings from peri-procedural transesophageal echocardiography (TEE) and outcomes of the lead extraction procedure. RESULTS: Lead perforations (including perforations <5 mm and ≥5 mm) were detected in 66 (46%) patients and 73 (21%) leads. Lead perforation ≥5 mm were less common and detected in 13 (9%) of patients and 14 (4%) of leads. There was no significant difference in the rates of peri-procedural death, cardiac avulsion, cardiac tamponade or post-extraction pericardial effusion in patients with and without lead perforation. CONCLUSIONS: Incidental delayed lead perforations detected by CT are common and do not correlate with significant TEE findings or adverse peri-procedural outcomes in patients undergoing lead extraction. Larger studies are needed to further characterize the frequency and safety of these findings.

Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator.

BACKGROUND: The presence of a cardiovascular implantable electronic device has long been a contraindication for the performance of magnetic resonance imaging (MRI). We established a prospective registry to determine the risks associated with MRI at a magnetic field strength of 1.5 tesla for patients who had a pacemaker or implantable cardioverter-defibrillator (ICD) that was "non-MRI-conditional" (i.e., not approved by the Food and Drug Administration for MRI scanning). METHODS: Patients in the registry were referred for clinically indicated nonthoracic MRI at a field strength of 1.5 tesla. Devices were interrogated before and after MRI with the use of a standardized protocol and were appropriately reprogrammed before the scanning. The primary end points were death, generator or lead failure, induced arrhythmia, loss of capture, or electrical reset during the scanning. The secondary end points were changes in device settings. RESULTS: MRI was performed in 1000 cases in which patients had a pacemaker and in 500 cases in which patients had an ICD. No deaths, lead failures, losses of capture, or ventricular arrhythmias occurred during MRI. One ICD generator could not be interrogated after MRI and required immediate replacement; the device had not been appropriately programmed per protocol before the MRI. We observed six cases of self-terminating atrial fibrillation or flutter and six cases of partial electrical reset. Changes in lead impedance, pacing threshold, battery voltage, and P-wave and R-wave amplitude exceeded prespecified thresholds in a small number of cases. Repeat MRI was not associated with an increase in adverse events. CONCLUSIONS: In this study, device or lead failure did not occur in any patient with a non-MRI-conditional pacemaker or ICD who underwent clinically indicated nonthoracic MRI at 1.5 tesla, was appropriately screened, and had the device reprogrammed in accordance with the prespecified protocol. (Funded by St. Jude Medical and others; MagnaSafe ClinicalTrials.gov number, NCT00907361 .).

Clinical factors associated with baseline history of atrial fibrillation and subsequent clinical outcomes following initial implantable cardioverter-defibrillator placement.

BACKGROUND: Atrial fibrillation (AF) is frequently present in patients with heart failure (HF) and an implantable cardioverter-defibrillator (ICD). This study aims to identify clinical factors associated with a baseline history of AF in ICD recipients, and compares subsequent clinical outcomes in those with and without a baseline history of AF. METHODS: We studied 566 consecutive first-time ICD recipients at an academic center between 2011 and 2018. Logistic regression multivariable analyses were used to identify clinical factors associated with a baseline history of AF at the time of ICD implant. Cox-proportional hazard regression models were constructed for multivariate analysis to examine associations between a baseline history of AF with subsequent clinical outcomes, including ICD therapies, HF readmission, and all-cause mortality. RESULTS: Of all patients, 201 (36%) had a baseline history of AF at the time of ICD implant. In multivariate analyses, clinical factors associated with a baseline history of AF included hypertension, valvular heart disease, body weight, PR interval, and serum creatinine level. After multivariate adjustment for potential confounders, a baseline history of AF was associated with an increased risk of anti-tachycardia pacing (HR = 1.84, 95% CI = 1.19-2.85, P = .006), appropriate ICD shocks (HR = 1.80, 95% CI = 1.05-3.09, P = .032), and inappropriate ICD shocks (HR = 3.72, 95% CI = 1.7-7.77, P = .0001), but not other adverse outcomes. CONCLUSION: Among first-time ICD recipients, specific clinical characteristics were associated with a baseline history of AF at the time of ICD implant. After adjustment for potential confounders, a baseline history of AF was associated with a higher risk of all ICD therapies in follow-up.

Perioperative Interrogation of Medtronic Cardiovascular Implantable Electronic Devices: A Guide for Anesthesiologists.

This is the final review article in a 4-part series focusing on the perioperative management of the 4 major companies' cardiovascular implantable electronic devices (CIEDs) in the United States. This article presents information pertinent to the perioperative management of Medtronic (Minneapolis, MN) transvenous CIEDs, including responses to magnet application, interpretation of interrogation reports, and basic programming (eg, mode, rate, rate modulation, and tachyarrhythmia therapies). Information regarding the Medtronic Micra (Medtronic, Minneapolis, MN) has been published previously. In addition, it contains an introduction to the concept of magnetic resonance (MR) conditional devices and magnetic resonance imaging (MRI) practices.

Lead extraction for reduction of chronic pain related to cardiovascular implantable electronic device.

AIMS: Chronic pain at the cardiovascular implantable electronic device (CIED) generator or lead insertion site that is not otherwise manageable carries a IIA indication for extraction. However, limited data exist evaluating causes of pain and outcomes of extraction in eliminating pain. A multi-centre retrospective observational study was conducted to evaluate outcomes of patients undergoing device extraction for treatment of chronic device pain. METHODS AND RESULTS: Twenty-seven out of 2188 lead extraction candidates (1.3%) met the chronic pain IIA indication for extraction [50 ± 16 years; 14 (51%) women]. Onset, severity, triggers, and pain management were measured before and after extraction. Device type, procedure done (with/without reimplantation), and positive tissue cultures were noted. Pain was reported as constant (n = 14; 50%), intermittent (n = 13; 46%), and movement-triggered (n = 14; 50%). Average severity of pain was seven out of 10 (10 being the worst). Post-extraction, 18 (66%) received freedom from pain, including all patients with poorly formed pockets (n = 2) and subclinical infections (n = 2). Of the 18, 11 underwent reimplantation (61%) without recurrent pain. Nine still had pain (44 ± 17 years; seven women) after extraction. Eight of the nine underwent reimplantation, three on the contralateral chest wall and five ipsilaterally. Pain severity decreased (n = 5), increased (n = 1), or was unchanged (n = 3). CONCLUSION: Chronic pain at the CIED generator site can present as chronic or movement-triggered pain, and can be due to subclinical infection or a poorly formed device pocket. Extraction relieved constant and intermittent pain in two-thirds of patients. Extraction appears less successful in eliminating pain in women who undergo subsequent reimplantation.

Perioperative Interrogation of Biotronik Cardiovascular Implantable Electronic Devices: A Guide for Anesthesiologists.

Biotronik cardiovascular implantable electronic devices, specifically Biotronik pacemakers, contain unique features that are relevant to perioperative management. For example, Biotronik pacemakers have a programmable response to magnet application, a default magnet response that does not result in sustained asynchronous pacing, and a unique method of rate adaptation (eg, closed loop stimulation). This review article focuses on these unique features; the interpretation of Biotronik interrogation reports; and the basic programming (eg, mode, rate, rate adaptation, tachyarrhythmia therapies) relevant to the perioperative management of Biotronik cardiovascular implantable electronic devices.

Outcomes of repeated transvenous lead extraction.

INTRODUCTION: The outcomes of repeated cardiovascular implantable electronic device (CIED) lead extraction have not been well studied. We sought to determine the indications, outcomes, and safety of repeated lead extraction procedures. METHODS: This retrospective study was conducted using data from two medical centers, including 38 patients who had undergone two or more lead extraction procedures compared to 439 patients who had a single procedure. The electronic medical records and procedural databases were reviewed to determine the indications, procedural characteristics, and outcomes. The outcomes of the first procedure were compared to the outcomes of subsequent procedures. RESULTS: The 5-year cumulative probability of a repeated extraction procedure was 11% (95% confidence interval, 7%-15%). In 439 patients who underwent single lead extractions, 72% had device and lead related infections as the procedure indication compared to 39% for 38 patients who underwent repeated extraction (P < 0.001). The mean duration from device reimplant to repeated extraction procedures was 63 ± 48 months. Ninety-eight percent of the leads were removed completely in repeated procedures, similar to the 95% success rate of the first procedure (P = 0.51). There was no significant difference in major complication rate in the first or repeated extractions (2.6% vs 5.2%, P = 0.79). CONCLUSIONS: Repeated transvenous lead extraction is not uncommon. It had a high success rate comparable to that of the initial procedure and was not associated with an increased incidence of adverse events.