Angioscopic observation of venous endothelium after transvenous lead extraction with excimer laser sheath: Initial experience.
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ABSTRACT:
SUBMITTER: Nakawatase S
PROVIDER: S-EPMC9810997 | biostudies-literature | 2022 Nov
REPOSITORIES: biostudies-literature
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Angioscopic observation of venous endothelium after transvenous lead extraction with excimer laser sheath: Initial experience.
Nakawatase Satoshi S Minamiguchi Hitoshi H Hirayama Atsushi A Higuchi Yoshiharu Y
HeartRhythm case reports 20220806 11
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Project description:AimsWhile 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.Methods and resultsA systematic literature search was conducted to identify articles that assessed the safety and performance of the spectranetics laser sheath (SLS) II and GlideLight Excimer laser sheaths in TLE procedures between 1 April 2016 and 31 March 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. In total, 17 articles were identified and evaluated, including 1729 patients with 2887 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% [1440/1505; 95% CI: (94.9-98.2%)] per patient and 96.3% [1447/1501; 95% CI: (94.8-97.4%)] per lead, and the clinical success rate per patient was 98.3% [989/1010, 95% CI: (97.4-99.0%)]. The procedure-related death rate was 0.08% [7/1729, 95% CI: (0.00%, 0.34%)], with major and minor complication rates of 1.9% [41/1729; 95% CI: (1.2-2.8%)] and 1.9% [58/1729; 95% CI: (0.8-3.6%)], respectively.ConclusionThis meta-analysis demonstrated that excimer laser sheath-assisted TLE has high success and low procedural mortality rates. It provides clinicians with a reliable and valuable resource for extracting indwelling cardiac leads which require advanced extraction techniques.
| S-EPMC10655058 | biostudies-literature
Project description:BackgroundDuring transvenous lead extraction (TLE), a GlideLight laser sheath (Philips) cannot always be advanced over the lead, and crossover to the Evolution system (i.e., an Evolution RL sheath or Evolution Shortie RL sheath [Cook Medical]) is required. We aimed to determine the associated factors and outcomes of such device crossover.MethodsThis observational study included 112 patients who underwent TLE. The patients were divided into crossover and non-crossover groups. Outcomes and associated factors of crossover were evaluated.ResultsOverall, 57 (50.9%) patients required crossover to the Evolution system (crossover group), whereas 55 (49.1%) patients did not require crossover (non-crossover group). Clinical success rate was similar between the two groups (98.3% vs. 100%; p = 1.00). No major intraprocedural complications related to powered sheaths occurred. Multivariate logistic regression analysis results showed that dwell time of the oldest extracted lead (per year) (odds ratio [OR]: 1.18, 95% confidence interval [CI]: 1.02-1.36; p = .026), number of leads extracted per procedure (OR: 7.23, 95% CI: 1.74-29.99; p = .007), and use of a femoral approach (OR: 21.09, 95% CI: 2.33-190.67; p = .007) were associated factors of crossover. The cutoff for crossover was 7.7 years from the implant (sensitivity 90.5%, specificity 64.9%, area under the curve 0.80).ConclusionsBoth groups showed a high rate of clinical success. Switching to the Evolution system may facilitate a safe and effective TLE when a laser sheath does not advance despite laser activation.
| S-EPMC10692839 | biostudies-literature
Project description:The need for transvenous lead extraction (TLE) is increasing worldwide including in Asia-Pacific regions. However, supporting evidence for TightRail, a relatively new rotating mechanical dilator sheath, is still lacking in Asian patients. The efficacy and safety of TLE using TightRail performed between March 2018 and June 2021 were evaluated in 86 consecutive patients with 131 leads. The mean lead age was 11.7 ± 7.3 (range, 1.0-41.4) years. Clinical and complete procedural success using TightRail were achieved in 93.0% and 89.5% of 86 patients, respectively, with 6 min of median fluoroscopic time and 9.3% of major complication rate: death (1.2%), cardiac tamponade (3.5%), severe tricuspid regurgitation (3.5%), and stroke (1.2%). However, in 46 patients with longest lead age ≤ 10 years, clinical/complete success and major cardiac complication rates turned out better as 97.8%, 95.7%, and 2.2%, respectively. Additionally, when patients were divided into 3 groups: the first 28, second 29, and the last 29 patients, there was a clear trend toward better efficacy and safety outcomes with more experience with TightRail (Ptrend < 0.05). Longest lead age > 10 years was closely associated with TLE-related major cardiac complication (P = 0.046) with 85.7% sensitivity, 57.0% specificity, 15.0% positive predictive value, and 97.8% negative predictive values. In conclusion, TLE using TightRail may be effectively and safely performed by experienced operators for Asian patients with the longest lead age ≤ 10 years. However, as TightRail is a potentially aggressive tool, special attention should be paid to patients with longer lead dwelling times (e.g., > 10 years).
| S-EPMC8764071 | biostudies-literature
Project description:AimsTransvenous lead extraction (TLE) is performed using non-laser and laser techniques with overall high efficacy and safety. Variation in outcomes between the two approaches does exist with limited comparative evidence in the literature. We sought to compare non-laser and laser TLE in a meta-analysis.Methods and resultsWe searched Medline, Embase, Scopus, ClinicalTrials.gov, and CENTRAL databases for TLE studies published between 1991 and 2021. From the included 68 studies, safety and efficacy data were carefully evaluated and extracted. Aggregated cases of outcomes were used to calculate odds ratio (OR), and pooled rates were synthesized from eligible studies to compare non-laser and laser techniques. Subgroup comparison of rotational tool and laser extraction was also performed. Non-laser in comparison with laser had lower procedural mortality (pooled rate 0% vs. 0.1%, P < 0.01), major complications (pooled rate 0.7% vs. 1.7%, P < 0.01), and superior vena cava (SVC) injury (pooled rate 0% vs. 0.5%, P < 0.001), with higher complete success (pooled rate 96.5% vs. 93.8%, P < 0.01). Non-laser comparatively to laser was more likely to achieve clinical [OR 2.16 (1.77-2.63), P < 0.01] and complete [OR 1.87 (1.69-2.08), P < 0.01] success, with a lower procedural mortality risk [OR 1.6 (1.02-2.5), P < 0.05]. In the subgroup analysis, rotational tool compared with laser achieved greater complete success (pooled rate 97.4% vs. 95%, P < 0.01) with lower SVC injury (pooled rate 0% vs. 0.7%, P < 0.01).ConclusionNon-laser TLE is associated with a better safety and efficacy profile when compared with laser methods. There is a greater risk of SVC injury associated with laser sheath extraction.
| S-EPMC10638006 | biostudies-literature
Project description:High-intensity laser plasma-based ion accelerators provide unsurpassed field gradients in the megavolt-per-micrometer range. They represent promising candidates for next-generation applications such as ion beam cancer therapy in compact facilities. The weak scaling of maximum ion energies with the square-root of the laser intensity, established for large sub-picosecond class laser systems, motivates the search for more efficient acceleration processes. Here we demonstrate that for ultrashort (pulse duration ~30 fs) highly relativistic (intensity ~10(21) W cm(-2)) laser pulses, the intra-pulse phase of the proton acceleration process becomes relevant, yielding maximum energies of around 20 MeV. Prominent non-target-normal emission of energetic protons, reflecting an engineered asymmetry in the field distribution of promptly accelerated electrons, is used to identify this pre-thermal phase of the acceleration. The relevant timescale reveals the underlying physics leading to the near-linear intensity scaling observed for 100 TW class table-top laser systems.
| S-EPMC3621399 | biostudies-literature
Project description: Not available
| S-EPMC1766991 | biostudies-literature
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.
| S-EPMC9856719 | biostudies-literature
Project description:IntroductionCardiac implantable electronic device (CIED) trans venous lead extraction (TLE) is technically challenging. Whether the use of a laser sheath reduces complications and improves outcomes is still in debate. We therefore aimed at comparing our experience with and without laser in a large referral center.MethodsInformation of all patients undergoing TLE was collected prospectively. We retrospectively compared procedural outcomes prior to the introduction of the laser sheath lead extraction technique to use of laser sheath.ResultsDuring the years 2007-2017, there were 850 attempted lead removals in 407 pts. Of them, 339 (83%) were extracted due to infection, device upgrade/lead malfunction in 42 (10%) cases, and other (7%). Complete removal (radiological success) of all leads was achieved in (88%). Partial removal was achieved in another 6% of the patients. Comparison of cases prior to and after laser technique introduction, showed that with laser, a significantly smaller proportion of cases required conversion to femoral approach [31/275 (6%) laser vs. 40/132 (15%) non-laser; p<0.001]. However, success rates of removal [259/275 (94%) vs. 124/132 (94%) respectively; p = 0.83] and total complication rates [35 (13%) vs. 19 (14%) respectively; p = 0.86] did not differ prior to and after laser use. In multivariate analysis, laser-assisted extraction was an independent predictor for no need for femoral extraction (OR = 0.39; 95% CI 0.23-0.69; p = 0.01).ConclusionIntroduction of laser lead removal resulted in decreased need to convert to femoral approach, albeit without improving success rates or preventing major complications.
| S-EPMC6488060 | biostudies-literature
Project description:We experienced a case of lead-related SVC syndrome, which was successfully treated using unique transvenous lead extraction technique and endovascular stenting. This case also suggests that intravascular ultrasound facilitates decision-making on whether the interventionist should perform TLE alone or add stenting in case of a lead-related venous obstruction.
| S-EPMC10549838 | biostudies-literature
Project description:BackgroundMalignant cardiac tumours are rare entities that cause severe morbidity and mortality. Possible treatment options vary between surgical removement, (immuno-) chemotherapy, and palliative care, whilst diagnostic workup comprises of imaging and histopathology analysis. Excimer laser sheaths are a new possibility to extract significant tissue samples to offer adequate treatment.Case summaryA 67-year-old Caucasian female presented with progressive shortness of breath, new onset of fevers, weight loss, and recurrent night sweats. She showed signs of upper venous stasis.Cardiac imaging revealed an obstructive, hypoperfused right atrial mass superior to the tricuspid valve and a sessile structure at the mitral valve. Guideline-directed therapy for endocarditis was started subsequently.A conventional intracardiac biopsy of the tumour was unsuccessful, but an off-label approach using an excimer laser sheath as bioptome leads to the diagnosis of a diffuse large B-cell lymphoma. Immuno-chemotherapy was commenced, leading to reduction in tumour size and rapid improvement in the quality of life.DiscussionIntracardiac biopsies are an important piece of the puzzle in the diagnostic workup of cardiac neoplasms. This case report is the first description of the utilization of a laser lead extraction tool as a bioptome for intracardiac tumours. Two imaging modalities (echocardiogram, fluoroscopy), as well as the precise technique of the excimer laser, ensured safety for the patient. Clinical studies are paramount to further evaluate the laser sheath as a possible new instrument in the toolbox of an interventional cardiologist.
| S-EPMC10010480 | biostudies-literature