Dataset Information

Incidence and Costs Related to Lead Damage Occurring Within the First Year After a Cardiac Implantable Electronic Device Replacement Procedure.

ABSTRACT:

Background

Inadvertent damage to leads for transvenous pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy defibrillators is an important complication associated with generator-replacement procedures. We sought to estimate the incidence and costs associated with transvenous lead damage following cardiac implantable electronic device replacement.

Methods and results

Using the Truven Health Analytics MarketScan Commercial Research Database, we identified health care claims between 2009 and 2013 for lead damage following generator replacement. Patients were identified by claims with a procedure code for cardiac implantable electronic device replacement and then evaluated for 1 year. All follow-up visits for lead damage were identified, and incidence, risk factors, and hospitalization costs were determined. A total of 22 557 patients with pacemakers, 20 632 with implantable cardioverter-defibrillators, and 2063 with cardiac resynchronization therapy defibrillators met selection criteria. Incidence of lead damage was 0.46% for pacemaker replacement, 1.27% for implantable cardioverter-defibrillator replacement, and 1.94% for cardiac resynchronization therapy defibrillator replacement procedures (P<0.001). After adjusting for patient characteristics, patients with implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators demonstrated risk of lead damage that was, respectively, double (hazard ratio 2.00, 95% CI 1.57-2.55) and >2.5 times (hazard ratio 2.58, 95% CI 1.73-3.83) that of patients with pacemakers. Lead revision or repair procedures were associated with increased inpatient hospitalization costs (mean $19 959 for pacemaker, $24 885 for implantable cardioverter-defibrillator, and $46 229 for cardiac resynchronization therapy defibrillator; P=0.048, Kruskal-Wallis test).

Conclusions

These findings establish the first objective assessment of the incidence, risk factors, and economic burden of lead damage following cardiac implantable electronic device replacement in the United States. New care algorithms are warranted to avoid these events, which impose substantial burdens on patients, physicians, and payors.

SUBMITTER: Nichols CI

PROVIDER: S-EPMC4802471 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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Incidence and Costs Related to Lead Damage Occurring Within the First Year After a Cardiac Implantable Electronic Device Replacement Procedure.

Nichols Christine I CI Vose Joshua G JG Mittal Suneet S

Journal of the American Heart Association 20160212 2

<h4>Background</h4>Inadvertent damage to leads for transvenous pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy defibrillators is an important complication associated with generator-replacement procedures. We sought to estimate the incidence and costs associated with transvenous lead damage following cardiac implantable electronic device replacement.<h4>Methods and results</h4>Using the Truven Health Analytics MarketScan Commercial Research Database, we ...[more]

PMID: 26873688

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Project description:Implantable device leads can cause tricuspid regurgitation (TR) when they interfere with leaflet motion. The aim of this study was to determine whether lead-leaflet interference is associated with TR severity, independent of other causative factors of functional TR.A total of 100 patients who underwent transthoracic two-dimensional and three-dimensional (3D) echocardiography of the tricuspid valve before and after lead placement were studied. Lead position was classified on 3D echocardiography as leaflet-interfering or noninterfering. TR severity was estimated by vena contracta (VC) width. Logistic regression analysis was used to identify factors associated with postdevice TR, including predevice VC width, right ventricular end-diastolic and end-systolic areas, fractional area change, right atrial size, tricuspid annular diameter, TR gradient, device lead age, and presence or absence of lead interference. Odds ratios were used to describe the association with moderate (VC width ? 0.5 cm) or severe (VC width ? 0.7 cm) TR, separately, using bivariate and stepwise multivariate logistic regression analysis.Forty-five of 100 patients showed device lead tricuspid valve leaflet interference. The septal leaflet was the most commonly affected (23 patients). On bivariate analysis, preimplantation VC width, right atrial size, tricuspid annular diameter, and lead-leaflet interference were significantly associated with postdevice TR. On multivariate analysis, preimplantation VC width and the presence of an interfering lead were independently associated with postdevice TR. Furthermore, the presence of an interfering lead was the only factor associated with TR worsening, increasing the likelihood of developing moderate or severe TR by 15- and 11-fold, respectively.Lead-leaflet interference as seen on 3D echocardiography is associated with TR after device lead placement, suggesting that 3D echocardiography should be used to assess for lead interference in patients with significant TR.

Project description:BackgroundThe implantation of cardiac implantable electronic devices (CIED) has increased in the last decades with improvement in the quality of life of patients with cardiac rhythm disorders. The presence of bilateral subclavian, innominate or superior vena cava obstruction is a major limitation to device revision and/or upgrade.Methods and materialThis is retrospective study of patients who underwent laser-assisted lead extraction (LLE) (GlideLight laser sheath, Spectranetics Corporation, Colorado Springs, USA) with lead revision or upgrade using the laser sheath as a guide rail. Patients with known occlusion, severe stenosis or functional obstruction of the venous access vessels with indwelling leads were included in this study.Results106 patients underwent percutaneous LLE with lead revision and/or upgrade. Preoperative known complete occlusion or severe stenosis of access veins was present in 23 patients (21.5%). More patients with implantable cardioverter-defibrillator (ICD) underwent LLE (64.1%) than patients with CRT-Ds (24.5%) and pacemaker patients (11.3%). In total 172 leads were extracted: 79 (45.9%) single-coil defibrillator leads, 35 (20.3%) dual-coil defibrillator leads, 31 (18.0%) right atrial leads, 24 (13.9%) right ventricular leads and three (1.7%) malfunctional coronary sinus left ventricular pacing leads. The mean age of leads was 99.2±65.6 months. The implantation of new leads after crossing the venous stenosis/obstruction was successful in 98 (92.4%) cases. Postoperative complications were pocket hematoma in two cases and wound infection in one case. No peri-operative and no immediate postoperative death was recorded. One intraoperative superior vena cava tear was treated by immediate thoracotomy and surgical repair.ConclusionIn a single-center study on LLE in the presence of supra-cardiac occlusion of the central veins for CIED lead upgrade and revision we could demonstrate a low procedural complication rate with no procedural deaths. Most of the leads could be completely extracted to revise or upgrade the system. Our study showed a low complication rate, with acceptable mortality rates.

Dataset Information

Incidence and Costs Related to Lead Damage Occurring Within the First Year After a Cardiac Implantable Electronic Device Replacement Procedure.

Background

Methods and results

Conclusions

Publications

Incidence and Costs Related to Lead Damage Occurring Within the First Year After a Cardiac Implantable Electronic Device Replacement Procedure.

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