Hybrid minimally invasive technique with the bidirectional rotational Evolution® mechanical sheath for transvenous lead extraction: A collaboration between electrophysiologists and cardiac surgeons.
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ABSTRACT:
SUBMITTER: Migliore F
PROVIDER: S-EPMC6009986 | 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:BackgroundTransvenous lead extraction (TLE) plays a critical role in managing patients with cardiovascular implantable electronic devices. Mechanical TLE tools, including rotational sheaths, are used to overcome fibrosis and calcification surrounding leads. Prospective clinical data are limited regarding the safety and effectiveness of use of mechanical TLE devices, especially rotational tools.ObjectiveTo prospectively investigate the safety and effectiveness of mechanical TLE in real-world usage.MethodsPatients were enrolled at 10 sites in the United States and Europe to evaluate the use of mechanical TLE devices. Clinical success, complete procedural success, and complications were evaluated through follow-up (median, 29 days). Patient data were source verified and complications were adjudicated by an independent clinical events committee (CEC).ResultsBetween October 2018 and January 2020, mechanical TLE tools, including rotational sheaths, were used to extract 460 leads with a median indwell time of 7.4 years from 230 patients (mean age 64.3 ± 14.4 years). Noninfectious indications for TLE were more common than infectious indications (61.5% vs 38.5%, respectively). The extracted leads included 305 pacemaker leads (66.3%) and 155 implantable cardioverter-defibrillator leads (33.7%), including 85 leads with passive fixation (18.5%). A bidirectional rotational sheath was needed for 368 leads (88.0%). Clinical success was obtained in 98.7% of procedures; complete procedural success was achieved for 96.3% of leads. CEC-adjudicated device-related major complications occurred in 6 of 230 (2.6%) procedures. No isolated superior vena cava injury or procedural death occurred.ConclusionThis prospective clinical study demonstrates that use of mechanical TLE tools, especially bidirectional rotational sheaths, are effective and safe.
| S-EPMC8183877 | 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:Although the Needle's Eye Snare (Cook Medical) has been considered useful for lead extraction, serious complications can occur. We presented a case of atrial septal perforation associated with the Needle's Eye Snare. Our case highlights the importance of not persisting with the Needle's Eye Snare to prevent atrial damage.
| S-EPMC8485817 | biostudies-literature
Project description:IntroductionThe CIMZIA® AutoClicks® pre-filled pen (CZP PFP) was developed to overcome barriers to self-injection, by improving self-injection confidence, reducing fear associated with needle use, and supporting patients with impaired dexterity. The purpose of this research was to gather feedback on injection experience and the usefulness of training materials.MethodsEligible patients with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA) were at least 18 years of age and initiated onto the CZP PFP. Routine self-injection training and support were provided by trained specialist nurses. Patient experience (pain and skin reactions, confidence, satisfaction, and ease of use) was evaluated at visits 1-3 using an amended version of the self-injection assessment questionnaire (SIAQ) v2.0. Nurse and patient feedback on the training materials, and nurse opinions on patient self-injection after self-injection at visit 1, were also collected.ResultsOf 355 patients invited to participate, 196 provided informed consent and 79 participated in all three visits. Patients generally found the CZP PFP easy to use, and self-confidence and satisfaction were high. From visit 1 to visit 3, there was a numerical trend towards improvement in all three aspects of patient experience, most notably in both confidence and satisfaction. After self-injection at visit 1, confidence around safe patient self-injection was higher among nurses than among patients. Meanwhile, "pain and skin reactions" remained low at all visits. Patients thought the training materials contained sufficient information and were easy to understand and useful.ConclusionAfter training, patients generally found the device easy to use and showed high confidence and satisfaction with self-injection. Some patients may have been competent (based on nurse opinion), but initially lacked self-confidence. Increasing self-injection experience, together with patient training and continued support, may have facilitated high patient confidence and satisfaction, thereby potentially overcoming some of the barriers to self-injection.
| S-EPMC7140744 | biostudies-literature
Project description: Not available
| S-EPMC7987895 | biostudies-literature
Project description:(1) Background: In patients referred for transvenous lead extraction (TLE) transesophageal echocardiography (TEE) often reveals abnormalities related to chronically indwelling endocardial leads. The purpose of this study was to determine whether the results of pre-operative TEE might influence the long-term prognosis. (2) Methods: We analyzed data from 936 TEE examinations performed at a high volume center in patients referred for TLE from 2015 to 2019. The follow-up was 566.2 ± 224.5 days. (3) Results: Multivariate analysis of TEE parameters showed that vegetations (HR = 2.631 [1.738-3.983]; p < 0.001) and tricuspid valve (TV) dysfunction unrelated to the endocardial lead (HR = 1.481 [1.261-1.740]; p < 0.001) were associated with increased risk for long-term mortality. Presence of fibrous tissue binding sites between the lead and the superior vena cava (SVC) and/or right atrium (RA) wall (HR = 0.285; p = 0.035), presence of penetration or perforation of the lead through the cardiac wall up to the epicardium (HR = 0.496; p = 0.035) and presence of excessive lead loops (HR = 0.528; p = 0.026) showed a better prognosis. After adjustment the statistical model with recognized poor prognosis factors only vegetations were confirmed as a risk factor (HR = 2.613; p = 0.039). A better prognosis was observed in patients with fibrous tissue binding sites between the lead and the superior vena cava (SVC) and/or right atrium (RA) wall (HR = 0.270; p = 0.040). (4) Conclusions: Non-modifiable factors may have a negative influence on long-term survival after TLE. Various forms of connective tissue overgrowth and abnormal course of the leads modifiable by TLE can be a factor of better prognosis after TLE.
| S-EPMC7918219 | biostudies-literature
Project description:A Minimally Destructive Protocol for DNA Extraction from Ancient Teeth
| PRJEB32750 | ENA
Project description:Poloxamer 407 copolymer is a versatile and widely used thermo-reversible material. Its use has many advantages, such as bio-adhesion, enhanced solubilization of poorly water-soluble drugs and many applications fields like oral, rectal, topical, nasal drug administration. Hydrogels made up of Poloxamer 407 are characterized by specific rheological features, which are affected by temperature, concentration and presence of other compounds. A strategic approach in topical therapeutic treatments may be the inclusion of drug delivery systems, such as ethosomes, transfersomes and niosomes, into hydrogel poloxamer formulation. The evaluation of the interaction between colloidal carriers and the Poloxamer 407 hydrogel network is essential for a suitable design of an innovative topical dosage form. For this reason, the Rheolaser Master™, based on diffusing wave spectroscopy, and a Kinexus Rotational Rheometer were used to evaluate the influence of nanocarriers on the microrheological features of hydrogels. The advantages of the Rheolaser Master™ analyzer are: (i) its ability to determine viscoelastic parameter, without altering or destroying the sample and at rest (zero shear); (ii) possibility of aging analysis on the same sample. This study provide evidence that vesicular systems do not influence the rheological features of the gel, supporting the possibility to encapsulate an innovative system into a three-dimensional network.
| S-EPMC7221562 | 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