Dataset Information

Safety and success of transvenous lead extraction using excimer laser sheaths: a meta-analysis of over 1700 patients.

ABSTRACT:

Background and aims

While numerous studies have demonstrated favorable safety and efficacy of the excimer laser sheath for transvenous lead extraction (TLE) in smaller cohorts, comprehensive large-scale investigations with contemporary data remain scarce. This study aims to evaluate the safety and performance of laser assisted TLE through a meta-analysis of contemporary data.

Methods

A systematic literature search was conducted to identify articles which assessed the safety and performance of the SLS II and GlideLight Excimer laser sheaths in TLE procedures between April 1, 2016 and March 31, 2021. Safety outcomes included procedure-related death and major/minor complications. Performance outcomes included procedural and clinical success rates. A random-effects, inverse-variance-weighting meta-analysis was performed to obtain the weighted average of the evaluated outcomes.

Results

In total, 17 articles were identified and evaluated, including 1,729 patients with 2,887 leads. Each patient, on average, had 2.3 ± 0.3 leads with a dwell time of 7.9 ± 3.0 years. The TLE procedural successes rate was 96.8% (1,440/1,505; 95% CI: [94.9%-98.2%]) per patient and 96.3% (1,447/1,501; 95% CI: [94.8%-97.4%]) per lead, and the clinical success rate per patient was 98.3% (989/1,010, 95% CI: [97.4%-99.0%]). The procedure-related death rate was 0.08% (7/1,729, 95% CI: [0.00%, 0.34%]), with major and minor complication rates of 1.9% (41/1,729; 95% CI: [1.2%-2.8%]) and 1.9% (58/1,729; 95% CI: [0.8%-3.6%]), respectively.

Conclusion

This meta-analysis demonstrated that excimer laser sheath assisted TLE has high success and low procedural mortality rates. It provides clinicians a reliable and valuable resource for extracting indwelling cardiac leads which require advanced extraction techniques.

SUBMITTER: Rinaldi CA

PROVIDER: S-EPMC10655058 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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Publications

Safety and success of transvenous lead extraction using excimer laser sheaths: a meta-analysis of over 1700 patients.

Rinaldi Christopher Aldo CA Diemberger Igor I Biffi Mauro M Gao Yu-Rong YR Sizto Enoch E Jin Nancy N Epstein Laurence M LM Defaye Pascal P

Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology 20231101 11

<h4>Aims</h4>While numerous studies have demonstrated favourable safety and efficacy of the excimer laser sheath for transvenous lead extraction (TLE) in smaller cohorts, comprehensive large-scale investigations with contemporary data remain scarce. This study aims to evaluate the safety and performance of laser-assisted TLE through a meta-analysis of contemporary data.<h4>Methods and results</h4>A systematic literature search was conducted to identify articles that assessed the safety and perfo ...[more]

PMID: 37757839

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Project description:ImportanceDespite historically high rates of use, most inferior vena cava (IVC) filters are not retrieved. The US Food and Drug Administration safety communications recommended retrieval when the IVC filter is no longer indicated out of concern for filter-related complications. However, failure rates are high when using standard techniques for retrieval of long-dwelling filters, and until recently, there have been no devices approved for retrieval of embedded IVC filters.ObjectiveTo evaluate the safety and success of excimer laser sheath-assisted retrieval of embedded IVC filters.Design, setting, and participantsA retrospective, multicenter, clinical cohort study of excimer laser sheath-assisted IVC filter retrievals from 7 US sites was conducted between March 1, 2012, and February 28, 2021, among 265 patients who underwent IVC filter retrieval using the laser. Patients were substratified between a high-volume single center and a multicenter data set. A blinded physician committee adjudicated reported complications and their association with use of the laser.ExposuresRetrieval of IVC filters using excimer laser sheath.Main outcomes and measuresThe primary safety end point was device-related major complication rate (Society of Interventional Radiology categories C to F, which included any adverse event associated with morbidity or disability that increases the level of care, results in hospital admission, or substantially lengthens the hospital stay). The primary success end point was technical success of IVC filter retrieval. The primary end points were compared with literature-derived, meta-analysis-suggested target performance goals.ResultsThe single-center experience included 139 participants (mean [SD] age, 52 [16] years; 78 female participants [56.1%]), and the multicenter experience included 126 participants (mean [SD] age, 52 [16] years; 75 female participants [59.5%]). The device-related major complication rate was 2.9% (4 of 139; 95% CI, 0.8%-7.2%; P = .001) for the single-center experience and 4.0% (5 of 126; 95% CI, 1.3%-9.0%; P = .01) for the multicenter experience, both of which were significantly lower than the primary safety performance goal (10%). No major complications were considered to be definitively associated with use of the laser. The technical success rate was 95.7% (133 of 139; 95% CI, 90.8%-98.4%; P = .007) for the single-center experience and 95.2% (120 of 126; 95% CI, 89.9%-98.2%; P = .02) for the multicenter experience, both of which were significantly higher than the primary performance goal (89.4%).Conclusions and relevanceThis cohort study demonstrated high technical success and low complication rates of excimer laser sheath-assisted retrieval of embedded IVC filters in centers with variable case volume and experience, which suggests a wide applicability of the technique with proper training. The excimer laser sheath offers physicians a valuable tool for retrieval of challenging embedded IVC filters.

Dataset Information

Safety and success of transvenous lead extraction using excimer laser sheaths: a meta-analysis of over 1700 patients.

Background and aims

Methods

Results

Conclusion

Publications

Safety and success of transvenous lead extraction using excimer laser sheaths: a meta-analysis of over 1700 patients.

Similar Datasets

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