Transvenous extraction of implantable cardioverter-defibrillator leads under advisory—A comparison of Riata, Sprint Fidelis, and non-recalled implantable cardioverter-defibrillator leads

Brunner, Michael; Cronin, Edmond M.; Jacob, Jessen; Duarte, Valeria E.; Tarakji, Khaldoun G.; Martin, David O.; Callahan, Thomas; Borek, Peter; Cantillon, Daniel J.; Niebauer, Mark; Saliba, Walid; Kanj, Mohamed; Wazni, Oussama; Baranowski, Bryan; Wilkoff, Bruce L.

doi:10.1016/j.hrthm.2013.06.021

Cited by 61 publications

(64 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Periprocedural complication rates following TLR have ranged from 1% to 6.7% in smaller studies of high-volume centers. 3,11,[15][16][17][18][19][20][21] In the world survey of cardiac pacing and cardioverter-defibrillators, all 81 centers involved reported major complications in their experience: 63% of centers in <1% of patients, 27% in 1% to 2%, 7.5% in 2% to 5%, and 2.5% of centers in >5% of patients. Absence of death was stated by 54% of centers; 36% reported deaths in <0.5%; and 10% experienced an incidence of death in 0.5% to 2% of patients.…”

Section: Discussionmentioning

confidence: 99%

“…Most of the data pertaining to the safety and efficacy of TLR originated from specialized centers with extensive experience. [3][4][5] …”

mentioning

confidence: 99%

“…Most of the lead removal reports from high-volume centers report lower complication rates. 3,31 There is no standard public reporting for low-volume centers for any high-risk procedures. Atrial fibrillation ablation and percutaneous coronary intervention experience have suggested that low-volume centers have worse overall outcomes.…”

mentioning

confidence: 99%

See 2 more Smart Citations

Trends in Use and Adverse Outcomes Associated with Transvenous Lead Removal in the United States

et al. 2015

View full text Add to dashboard Cite

Background— Transvenous lead removal (TLR) has made significant progress with respect to innovation, efficacy, and safety. However, limited data exist regarding trends in use and adverse outcomes outside the centers of considerable experience for TLR. The aim of our study was to examine use patterns, frequency of adverse events, and influence of hospital volume on complications. Methods and Results— Using the Nationwide Inpatient Sample, we identified 91 890 TLR procedures. We investigated common complications including pericardial complications (hemopericardium, cardiac tamponade, or pericardiocentesis), pneumothorax, stroke, vascular complications (consisting of hemorrhage/hematoma, incidents requiring surgical repair, and accidental arterial puncture), and in-hospital deaths described with TLR, defining them by the validated International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code. We specifically assessed in-hospital death (2.2%), hemorrhage requiring transfusion (2.6%), vascular complications (2.0%), pericardial complications (1.4%), open heart surgery (0.2%), and postoperative respiratory failure (2.4%). Independent predictors of complications were female sex and device infections. Hospital volume was not independently associated with higher complications. There was a significant rise in overall complication rates over the study period. Conclusions— The overall complication rate in patients undergoing TLR was higher than previously reported. Female sex and device infections are associated with higher complications. Hospital volume was not associated with higher complication rates. The number of adverse events in the literature likely underestimates the actual number of complications associated with TLR.

show abstract

Section: Discussionmentioning

confidence: 99%

“…Most of the data pertaining to the safety and efficacy of TLR originated from specialized centers with extensive experience. [3][4][5] …”

mentioning

confidence: 99%

See 1 more Smart Citation

Trends in Use and Adverse Outcomes Associated with Transvenous Lead Removal in the United States

et al. 2015

View full text Add to dashboard Cite

show abstract

“…This coupled with several high-profile device recalls and an increased rate of device infection have led to a greater need for transvenous lead extraction (TLE). [1][2][3][4][5] The consensus report from 2009 estimated that 10 to 15 000 TLEs occur globally per year, but this number is almost certainly larger now. 6 TLE has the potential for infrequent but serious complications; in their worst form, these complications are characterized by cardiac or vascular perforation.…”

mentioning

confidence: 99%

Classification and Surgical Repair of Injuries Sustained During Transvenous Lead Extraction

Bashir

Fedoruk

Ofiesh

et al. 2016

Circ: Arrhythmia and Electrophysiology

View full text Add to dashboard Cite

Background-Injuries to cardiac and venous structures during pacemaker and defibrillator lead extraction are serious complications that have been studied poorly. The incidence of these injuries is unknown but likely underestimated. No systematic multicenter review of these injuries or their management has been undertaken. Methods and Results-We interrogated our mandatory administrative database for all excimer laser extractions that sustained a cardiac or venous injury in the province of British Columbia. Injuries were classified according to presentation and compared with respect to nature of injury, type of repair, utilization of cardiopulmonary bypass, and outcome. Of 1082 excimer laser extractions over 19 years, 33 sustained an injury (3.0%). The majority of injuries occurred in women (21/33; 63.6%), and median age of oldest lead extracted was 10.8 (7.5, 12.2) years. A type 1 presentation, defined as circulatory collapse, was found in 12/33 patients (36.4%). A type 2 presentation, defined as progressive hypotension responsive to treatment, was found in 20/33 patients (60.6%). Over half the patients had a moderate or large injury, and cardiopulmonary bypass was required in 13 patients with extensive injury. Despite the presence of devastating injuries, the immediate availability of aggressive salvage measures resulted in a survival of 87.9% of patients at 30 days. Conclusions-The immediate availability of a cardiovascular surgeon, perfusionist, and cardiopulmonary bypass pump facilitates lifesaving repair of injuries sustained during laser lead extraction. The size and complexity of injury correlates closely with the presentation, blood loss, and need for cardiopulmonary bypass to facilitate repair. (Circ Arrhythm Electrophysiol. 2016;9:e003741.

show abstract

“…Registry reports have largely focused on outcomes in a defined product's patient population, with limited implant related data beyond vein access. [6][7][8][9][10] We sought to determine detailed lead-related implant factors that contributed to risk of fracture in the Medtronic Fidelis lead advisory population, using a case-control detailed radiographic analysis.…”

mentioning

confidence: 99%

Radiographic Predictors of Lead Conductor Fracture

Krahn

Morissette

Lahm

et al. 2014

Circ: Arrhythmia and Electrophysiology

View full text Add to dashboard Cite

All 23 adult Canadian implantable cardioverter defibrillator implantation centers were surveyed to identify centers that routinely capture anteroposterior or posteroanterior (AP) and lateral x-rays within 2 weeks of implant and at least AP x-rays at the time of fracture identification. Eight of those centers collected those x-rays routinely. All eligible centers agreed to participate in the study. Centers were © 2014 American Heart Association, Inc. Original ArticleBackground-Lead fracture is a limiting factor in high voltage lead durability. Fractures noted with the Medtronic Fidelis leads provide an opportunity to examine factors captured on implant chest x-ray that correlate with risk for lead conductor fracture. We evaluated contributory factors in a large population of fractures. Methods and Results-We conducted a retrospective case-control study at 8 Canadian centers that routinely capture anterior posterior and lateral chest x-rays within 2 weeks of implant. Cases were patients that experienced confirmed Medtronic Fidelis 6949 lead fracture based on standard definitions, matched one-to-one to controls for date of implant, sex, and age with normally functioning Fidelis leads from the same center. Select chart data and x-rays were collected for all patients. Radiographic measurements by ≥2 individuals per case/control were blinded to patient status. The data were analyzed using a time to failure multivariable Cox proportional hazards model with stratification for each matched pair. X-ray pairs from 111 fracture patients were compared with 111 controls (age 61.5±12.8 years, 75% male, 221 model 6949 leads). Six parameters included in the statistical analysis were significantly associated with risk of fracture, including slack/ tortuosity measures, pulse generator and superior vena cava coil location, and angle of lead exit from the pocket. Conclusions-Pocket, intravascular and intracardiac lead characteristics on x-ray correlate with risk of lead conductor fracture. These observations may be useful to direct implant technique to optimize lead durability. Validation in larger populations and other lead models may inform the application of these results. (Circ Arrhythm Electrophysiol.

show abstract

Transvenous extraction of implantable cardioverter-defibrillator leads under advisory—A comparison of Riata, Sprint Fidelis, and non-recalled implantable cardioverter-defibrillator leads

Cited by 61 publications

References 14 publications

Trends in Use and Adverse Outcomes Associated with Transvenous Lead Removal in the United States

Trends in Use and Adverse Outcomes Associated with Transvenous Lead Removal in the United States

Classification and Surgical Repair of Injuries Sustained During Transvenous Lead Extraction

Radiographic Predictors of Lead Conductor Fracture

Contact Info

Product

Resources

About