Novel Use of a Rotating Mechanical Dilator Sheath for S-ICD Lead Extraction.
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ABSTRACT:
SUBMITTER: Allison JD
PROVIDER: S-EPMC8446045 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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: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.
| S-EPMC8121537 | biostudies-literature
Project description:We report a case of a 63-year-old man referred for lead extraction with the bidirectional rotational Evolution ® RL mechanical sheath because of systemic infection. As it was judged a "high-risk" procedure, we opted for a "hybrid," minimally invasive approach consisting in a minithoracotomic access. This technique is a feasible approach, and it might be a potential safer alternative in the most challenging transvenous lead extraction procedures.
| S-EPMC6009986 | biostudies-literature
Project description:Background: When an implantable-cardioverter defibrillator (ICD) lead becomes non-functional, a recommendation currently exists for either lead abandonment or removal. Lead abandonment and subcutaneous ICD (S-ICD) implantation may represent an additional option for patients who do not require pacing. The aim of this study was to investigate the outcomes of a strategy of lead abandonment and S-ICD implantation in the setting of lead malfunction. Methods: We analyzed all consecutive patients who underwent S-ICD implantation after abandonment of malfunctioning leads and compared their outcomes with those of patients who underwent extraction and subsequent reimplantation of a single-chamber transvenous ICD (T-ICD). Results: Forty-three patients underwent S-ICD implantation after abandonment of malfunctioning leads, while 62 patients underwent extraction and subsequent reimplantation of a new T-ICD. The two groups were comparable. In the extraction group, no major complications occurred during extraction, while the procedure failed and an S-ICD was implanted in 4 patients. During a median follow-up of 21 months, 3 major complications or deaths occurred in the S-ICD group and 11 in the T-ICD group (HR 1.07; 95% CI 0.29-3.94; P = 0.912). Minor complications were 4 in the S-ICD group and 5 in the T-ICD group (HR 2.13; 95% CI 0.49-9.24; P = 0.238). Conclusions: In the event of ICD lead malfunction, extraction avoids the potential long-term risks of abandoned leads. Nonetheless the strategy of lead abandonment and S-ICD implantation was feasible and safe, with no significant increase in adverse outcomes, and may represent an option in selected clinical settings. Further studies are needed to fully understand the potential risks of lead abandonment. Clinical Trial Registration: URL: ClinicalTrials.gov Identifier: NCT02275637.
| S-EPMC8356671 | biostudies-literature
Project description:A 49-year-old man was admitted with symptomatic, sustained monomorphic ventricular tachycardia. He had a previous history of AMP-kinase disease associated with hypertrophic cardiomyopathy and complete heart block, and a pre-existing dual chamber pacemaker. He also had a mechanical tricuspid valve replacement and mitral valve replacement, for severe tricuspid regurgitation from right ventricle (RV) lead-induced injury to the tricuspid valve and a fibroblastoma on the mitral valve. His pre-existing RV lead was maintained between the prosthetic valve annulus and the native annulus. Inability to place an implantable cardioverter-defibrillator (ICD) in the RV due to the presence of a mechanical tricuspid valve replacement represented a rare but challenging clinical scenario. Surgical epicardial lead placement or the use of a subcutaneous ICD (S-ICD) were possible alternatives. Traditional ICD lead placement was favored because of the broad QRS from RV pacing meaning that use of the S-ICD was not possible due to failure of the electrocardiogram to lie within the bounds of the screening template, and the perceived high risk of repeat thoracotomy. We describe the technique for ICD lead placement in a mid-lateral cardiac venous branch of the coronary sinus with the ability to deliver anti-tachycardia pacing and cardiac resynchronization. To our knowledge this is the first report of an ICD in the mid-lateral cardiac vein, with cardiac resynchronization. <Learning objective: This case describes the technique for implantable cardioverter-defibrillator placement in the coronary sinus with biventricular pacing in a patient with a mechanical tricuspid and pre-existing right ventricular endocardial lead. This technique represents a viable alternative to repeat thoracotomy and surgical lead placement, where the risks of complication, prolonged hospital stay and lead failure are high. It also offers the ability to deliver anti-tachycardia pacing and cardiac resynchronization.>.
| S-EPMC6281873 | biostudies-other
Project description:Background and objectivesSuccessful tract dilation is one of the most important steps to accomplish EUS-guided drainage. Although mechanical dilation is safer than electrocautery dilation, no dedicated mechanical dilator (MD) is currently available. Thus, we developed a new ultra-tapered MD for EUS-guided drainage. This study aimed to evaluate the safety and usefulness of this novel MD.Patients and methodsConsecutive patients who underwent EUS-guided hepaticogastrostomy (EUS-HGS) or EUS-guided pancreatic duct drainage (EUS-PD) at two centers were included in the study. Dilation of the needle tract was initially performed with a diathermic sheath or the ultra-tapered MD. Technical success and adverse events were assessed.ResultsSixty-four patients (mean age = 68.9 ± 13.8 years, 35 men) underwent EUS-HGS (49 patients) and EUS-PD (15 patients). Thirty-three patients were included in the cautery dilator (CD) group and 31 in the ultra-tapered MD group. Initial dilation of the puncture site was achieved in 95.3% (61/64): 97% (32/33) of the patients in the CD group and 93.3% (29/31) of the patients in the MD group (P < 0.05). Adverse events were observed in 14 patients: abdominal pain in 8 patients and bleeding in 6 patients at the puncture site. All bleedings occurred in the CD group and there was no patient in whom bleeding occurred after EUS intervention in the MD group (P = 0.04).ConclusionThe novel ultra-tapered MD designed for interventional EUS appears to be safe and useful as it reduced postprocedure bleeding with a high technical success rate compared with the conventional electrocautery dilator.
| S-EPMC6289009 | biostudies-literature
Project description: Not available
| S-EPMC7987925 | biostudies-literature
Project description:BackgroundThe incidence, predictors, and clinical impact of lead break during transvenous lead extraction (TLE) were previously unknown.MethodsWe included consecutive patients who underwent TLE between September 2013 and July 2019 at our institute. Lead break during removal was defined as lead stretching and becoming misshapen, as assessed by fluoroscopy.ResultsA total of 246 patients underwent TLE for 501 leads. At a patient level, complete success was achieved in 226 patients (91.9%). At a lead level, 481 leads (96.0%) were completely removed and 101 leads (20.1%) were broken during the procedure. Of 392 identified pacemaker leads, 71 (18.3%) were broken during the TLE procedure. A multivariable analysis confirmed high lead age (odds ratio [OR] 1.12, 95% confidence interval (CI) 1.07-1.17; P < .001), passive leads (OR 2.29 95% CI 1.09-4.80; P = .028), coradial leads (OR 3.45 95% CI 1.72-6.92; P < .001), and insulators made of nonpolyurethane (OR 2.38 95% CI 1.03-5.26; P = .04) as predictors of lead break. Broken leads needed longer procedure times and were associated with a higher rate of cardiac tamponade.ConclusionsLead age, coradial bipolar leads, passive leads, and leads without polyurethane insulation were predictors of lead break and could increase the difficulty of lead extraction.
| S-EPMC8207345 | biostudies-literature
Project description:Vaginal stenosis (VS) after pelvic radiotherapy (RT) can impair long-term quality of life. We prospectively assessed adherence and efficacy of vaginal dilator (VD) use in women after pelvic RT.Women with gastrointestinal (n=63) and gynecologic (n=46) cancers self-reported use and VD size in monthly diaries for 12months after radiotherapy. Adherence was measured as actual VD use out of recommended times over 12months (3×/week×52weeks=156).Among 109 participants, aged 28-81years (median, 58years), mean percent adherence over 12months was 42% (95% confidence interval [CI], 36-48%). Adherence was highest in the first quarter (56%), but fell to 25% by the fourth. Disease type, treatment sequence, and chemotherapy were predictors of adherence (all P<.05). Eighty-two percent maintained pre-RT VD size at 12months; of 49% with a decrease in VD size at 1month post-RT, 71% returned to pre-RT VD size at 12months. Disease type, younger age, and increased adherence at 6months were associated with maintaining or returning to pre-RT size at 12months (all P?.05).VD use is effective in minimizing VS, but adherence at 12months was poor. Studies evaluating methods of improving adherence and determining the optimal frequency and duration of use are needed.
| S-EPMC5028178 | biostudies-literature
Project description:PurposeGuidelines for the care of women undergoing pelvic radiation therapy (RT) recommend vaginal dilator therapy (VDT) to prevent radiation-induced vaginal stenosis (VS); however, no standard protocol exists. This review seeks to update our current state of knowledge concerning VS and VDT in radiation oncology.Methods and materialsA comprehensive literature review (1972-2017) was conducted using search terms "vaginal stenosis," "radiation," and "vaginal dilator." Information was organized by key concepts including VS definition, time course, pathophysiology, risk factors, and interventions.ResultsVS is a well-described consequence of pelvic RT, with early manifestations and late changes evolving over several years. Strong risk factors for VS include RT dose and volume of vagina irradiated. Resultant vaginal changes can interfere with sexual function and correlational studies support the use of preventive VDT. The complexity of factors that drive noncompliance with VDT is well recognized. There are no prospective data to guide optimal duration of VDT, and the consistency with which radiation oncologists monitor VS and manage its consequences is unknown.ConclusionsThis review provides information concerning VS definition, pathophysiology, and risk factors and identifies domains of VDT practice that are understudied. Prospective efforts to monitor and measure outcomes of patients who are prescribed VDT are needed to guide practice.
| S-EPMC7944435 | biostudies-literature