Mechanical Dilator Sheath Research Articles

Systematic Review on S-ICD Lead Extraction.

Subcutaneous implantable cardioverter defibrillators (S-ICDs) have emerged in recent years as a valid alternative to traditional transvenous ICDs (TV-ICDs). Therefore, the number of S-ICD implantations is rising, leading to a consequent increase in S-ICD-related complications sometimes requiring complete device removal. Thus, the aim of this systematic review is to gather all the available literature on S-ICD lead extraction (SLE), with particular reference to the type of indication, techniques, complications and success rate. Studies were identified by searching electronic databases (Medline via PubMed, Scopus and Web of Science) from inception to 21 November 2022. The search strategy adopted was developed using the following key words: subcutaneous, S-ICD, defibrillator, ICD, extraction, explantation. Studies were included if they met both of the following criteria: (1) inclusion of patients with S-ICD; (2) inclusion of patients who underwent SLE. Our literature search identified 238 references. Based on the abstract evaluation, 38 of these citations were considered potentially eligible for inclusion, and their full texts were analyzed. We excluded 8 of these studies because no SLE was performed. Eventually, 30 studies were included, with 207 patients who underwent SLE. Overall, the majority of SLEs were performed for non-infective causes (59.90%). Infection of the device (affecting either the lead or the pocket) was the cause of SLE in 38.65% of cases. Indication data were not available in 3/207 cases. The mean dwelling time was 14 months. SLEs were performed using manual traction or with the aid of a tool designed for transvenous lead extraction (TLE), including either a rotational or non-powered mechanical dilator sheath. SLE is performed mainly for non-infective causes. Techniques vary greatly across different studies. Dedicated tools for SLE might be developed in the future and standard approaches should be defined. In the meantime, authors are encouraged to share their experience and data to further refine the existing variegated approaches.

First use of a rotating mechanical dilator sheath to extract an epicardial defibrillator lead from the pericardial space.

First use of a rotating mechanical dilator sheath to extract an epicardial defibrillator lead from the pericardial space.

Transvenous lead extraction using the TightRail mechanical rotating dilator sheath for Asian patients

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).

Outcomes of transvenous lead extraction using the TightRail™ mechanical rotating dilator sheath and excimer laser sheath.

Transvenous lead extraction (TLE) is an important part of comprehensive lead management. The selection of tools available has expanded in recent years but data on their efficacy is limited. To evaluate outcomes using the TightRail™ mechanical rotating mechanical dilator sheath in comparison to excimer laser sheaths and describe factors predictive of successful extraction. Patients undergoing TLE at a single tertiary center (2013-2019) were included in a prospective registry. Leads targeted for extraction with either an SLS II/Glidelight™ or TightRail™ sheath were included. Outcomes were analyzed on a per-lead basis. Generalized estimating equation (GEE) models were used to assess differences in lead extraction success by extraction tool used while adjusting for nonindependence of multiple leads extracted from the same patient. Covariates included patient comorbidities, lead characteristics, and sheath size. A total of 575 leads extracted from 372 patients were included. Overall success rate was 97%. TightRail™ was the first tool used in 180 (31.3%) leads with success rate of 61.7%; laser sheaths were the first tool in 395 leads (68.7%) with success rate of 67.8%. Predictors of successful extraction included lead age, lead type, and sheath sizing. Extraction success did not differ based on whether a laser or TightRail™ sheath was used (adjusted odds ratio = 0.94; 95% confidence interval = 0.59-1.50). The TightRail™ sheath is an effective tool for TLE. Lead age, lead type, and sheath sizing were predictive of successful extraction but sheath type was not. These findings are hypothesis generating and warrant further investigation in a prospective, randomized study.

Evolution Mechanical Dilator Sheath as a First Choice for Transvenous Lead Extraction

Evolution Mechanical Dilator Sheath as a First Choice for Transvenous Lead Extraction

P1235A stepwise strategy using TightRailTM Rotating Mechanical Dilator Sheath is safe and effective for transvenous lead extraction

P1235A stepwise strategy using TightRailTM Rotating Mechanical Dilator Sheath is safe and effective for transvenous lead extraction

A stepwise strategy using TightRailTM rotating mechanical dilator sheath is safe and effective for transvenous lead extraction

Worldwide demand for transvenous lead extraction (TLE) has significantly increased over the last decades. TightRail TM rotating-mechanical-sheath is one of the latest devices available for TLE. We aimed at comparing procedural safety and efficacy before and after the use of this system. Patients referred to our tertiary center for TLE from January 2014 to October 2016 were prospectively included. The TightRail TM became available in our center in May 2015. Patients were assigned to the non-TightRail TM group before May 2015 and to the TightRail TM group afterwards. The two strategies and their outcomes were compared. Procedural efficacy (definition of HRS consensus) and safety were compared in the two groups. Ninety-six patients were included (66.9 ± 12.5years). A total of 187 leads were extracted, divided in 102 (54.5%) and 85 (45.5%) leads in the non-TightRail TM and TightRail TM groups respectively. A trend towards complete procedural success per lead (87.3 vs 92.9% P = 0.232) or per patient (75.9 vs 83.3% P = 0.452) and clinical success per lead (89.2 vs 96.5% P = 0.092) or per patient (81.5 vs 90.5% P = 0.256) was observed. By multivariable analysis, the use of TightRail TM (OR = 3.75 and 5.94), ICD lead (OR = 0.30 and 0.18) and delay from implant (OR = 0.99 and 0.99) were associated with both complete and clinical success per lead. There was no difference regarding minor and major complications. TLE strategy using TightRail TM is safe and predicts a higher rate of complete procedural and clinical success per lead compared to a conventional approach.

Mechanical Dilator Sheath Markedly Damaged by Fibrosis

Mechanical Dilator Sheath Markedly Damaged by Fibrosis

Non-laser percutaneous extraction of pacemaker and defibrillation leads: a decade of progress

Non-laser-based methods are safe in lead extraction but in the past have been less effective than laser methods. In the past decade, new equipment has been introduced including the Evolution® Mechanical Dilator Sheath and the Evolution® RL. We sought to determine the impact of new equipment on outcome in mechanical lead extraction. We considered 288 consecutive patients (age 66 ± 18 years) who underwent transvenous lead extraction (TLE) of 522 leads in the decade to the end of 2014. Three groups were identified: Group 1 (pre-Evolution® period, 76 patients, 133 leads), Group 2 (original Evolution® period, 115 patients, 221 leads), and Group 3 (Evolution® RL period, 97 patients, 168 leads). The age of leads was significantly greater in Groups 2 and 3 (6.2 ± 4.4 and 6.1 ± 5.4 years vs.4.7 ± 4.5, P < 0.05) as was the proportion of implantable cardioverter defibrillator leads (27.2 and 28.9 vs. 14.3%, P < 0.05). The groups were similar in the number of leads extracted per patient. Despite the increasing complexity of the systems extracted, complete extraction was achieved in a progressively greater proportion of leads (88.0% in Group 1, 95.5% in Group 2, and 97.6% in Group 3, P < 0.05), and procedure duration was similar. The proportion of leads for which femoral access was required was greater in Group 3 (11%, 18/164) compared with Group 2 (3%, 7/211), P = 0.006. The only major complications were a post-procedure subacute tamponade in Group 1 and an oesophageal injury related to transoesophageal echocardiography in Group 3. With current equipment, mechanical extraction provides a good combination of efficacy and safety.

176-62: Usefulness of TightRail™ Rotating Mechanical Dilator Sheath for Transvenous Lead Extraction: Safety and Efficacy Outcomes

Purpose: In parallel with increasing implantation rates and patients' longer life expectancy, the need for transvenous lead extraction (TLE) as a specialized procedure has shown a significant growth over years. Herein, we aimed to present our initial experience in TLE by using a novel TightRail™ Rotating Mechanical Dilator Sheath. Methods: Between October 2014 and September 2015, a total of 64 leads in 35 patients were removed at our tertiary referral centre. All of the extracted leads were >12 months old and indications for extraction were based on the recommendations of the Heart Rhythm Society. The leads were removed by using the TightRail™ Mechanical Dilator Sheath (Spectranetics Corporation) with the rotational cutting force only. Results: Indications for lead removal included cardiac device infection in 22 (62.9%) cases, lead malfunction in the 12 (34.3%) cases and upgrade to CRT-D in the remaining 1 case (2.8%). The extracted devices were pacemaker in 12 (34.3%) cases, ICD in 13 (37.1%) cases and CRT in the remaining 10 (28.6%) subjects. Mean number of extracted leads per patient was 1.86 ± 0.77. Among 64 leads, 12 (18.8%) were right ventricular, 23 (35.9%) were atrial, 22 (34.3%) were defibrilator and 7 (10.9%) were coronary sinus electrodes. The median time from implantation was 60 (12–216) months. Complete procedural success with TightRail™ system alone was achieved in 33 (94.3%) patients (62/64 leads) and overall clinical success was 100%. One right ventricular and another right atrial leads were completely removed with the help of snaring. All the patients were discharged uneventfully without any complication. Conclusions: Our small sized study results showed that TightRail™ mechanical dilator sheath is a novel useful tool for chronically implanted PM/ICD leads. Continued investigation including large patient cohort is required to evaluate success and complication rates in comparison to other tools and techniques.

Transvenous extraction of pacemaker and implantable cardioverter defibrillator leads using Evolution® mechanical dilator sheath: a single center confirmatory experience.

ObjectiveIn recent years there has been an increase in clinical situations requiring lead extraction procedures of implanted cardiac devices. In our clinic, extraction procedures are performed with Evolution® mechanical lead extraction system. In this manuscript we aimed to evaluate our lead extraction procedures.MethodsWe retrospectively evaluated lead extraction procedures carried out on 41 patients [30 male, 11 female patient; mean age 61.5 ± 18.5 median 67 (23–85)] between 2008 and 2015 using Evolution® system. Procedural success, major and minor complications are determined according to previously published guidelines.ResultsMean duration of the lead implantation was 88.4 ± 62.5 months (6–240). Implanted device was a pacemaker in 27 (65.8 %) and ICD in 14 (34.2 %) of patients. Total 67 leads were extracted from the patients, 22 (32.8 %) were atrial, 30 (44.2 %) were ventricular, 14 (21.5 %) were dual coil defibrillator and 1 (1.5 %) was coronary sinus lead. Indications for lead removal were pacemaker decubitis and infection in 29 (70.8 %), lead dysfunction in 11 (26.8 %) and subclavian vein thrombosis in 1 (2.4 %) patient. Success rate with Evolution® system without using snare was 85.3 %. Clinical success rate was 97.5 % procedural success rate was 95.1 % and failure occured in one patient. Major complications occured in 2 (4.8 %) patients, 1 (2.4 %) was procedure related mortality. Minor complications were seen in 5 (12.2 %) of patients.ConclusionsIn our single center study it is shown that extraction of pacemaker and defibrillator leads of relatively long implantation duration and in an older age patient group may be successfully carried out using the Evolution® system. However due to potentially serious complications it is adviced to be done by experienced operators in centers with cardiovascular surgery backup.

A challenging case of transvenous lead extraction

A 72-year-old male patient with a 7-year history of cardioverter-defibrillator (ICD) implantation was admitted to our clinic with pocket infection. One year prior to this admission, he had undergone an unsuccessful extraction procedure at another clinic, during which the older broken ICD lead had been left in place and a newer ICD lead implanted via the same pocket. The newer and older leads were extracted by mechanical dilator sheath and needle eye snare respectively.

Evaluation of lead extraction procedures using the Evolution Mechanical Dilatator Sheath lead extraction system: A single centre experience

In recent years, there has been an increase in clinical situations requiring extraction of leads of implanted cardiac devices. This study aimed to evaluate the Evolution Mechanical Dilator Sheath system, presently in use in our clinic for lead extraction procedures. Lead extraction procedures carried out on 20 patients (14 men, 6 women; mean age 61±19; range 23 to 85 years) between 2008 and 2013 using the Evolution system were retrospectively evaluated. Procedural success, and major and minor complications were determined by previously published guidelines. Mean implantation duration of the leads was 97±65 months (8-204). Fifteen (75%) patients had undergone pacemaker implantation and 5 (25%) had been implanted with a defibrillator. A total of 35 leads were removed from the patients. Seventeen (49%) were ventricular and 12 (34%) were atrial. Five (14%) were defibrillator coils and 1 a coronary sinus lead. Indications for lead extraction were device infection in 18 (90%) patients and lead dysfunction in 2 (10%). Complete procedural success was 95%. Failure occurred in 1 patient. The major complication rate was 5% and minor complications were seen in 25% of patients. No case of mortality was present. In this single centre study, it was shown that extraction of pacemaker and defibrillator leads of longer implant duration may be successfully carried out using the Evolution system. However, due to potentially serious complications it is advised that extraction be done by an experienced operator in centres with cardiovascular surgery facilities.

Initial experience with the TightRail™ Rotating Mechanical Dilator Sheath for transvenous lead extraction

In parallel with increasing implantation rates and patients' longer life expectancy, the need for transvenous lead extraction (TLE) as a specialized procedure has shown a significant growth over years. Herein, we aimed to present our initial experience in TLE by using a novel TightRail™ Rotating Mechanical Dilator Sheath. Between October 2014 and March 2015, a total of 42 leads in 23 patients were removed at our tertiary referral centre. All of the extracted leads were >12 months old and indications for extraction were based on the recommendations of the Heart Rhythm Society. The leads were removed by using the TightRail™ Mechanical Dilator Sheath (Spectranetics Corporation) with the rotational cutting force only. Indications for lead removal included cardiac device infection in 12 (52.2%) cases, lead malfunction in the 10 (43.5%) cases, and upgrade to cardiac resynchronization therapy-defibrillator (CRT-D) in the remaining 1 case (4.3%). The extracted devices were pacemaker in 10 (43.4%) cases, implantable cardioverter-defibrillator (ICD) in 7 (30.4%) cases, and CRT in the remaining 6 (26.0%) subjects. Among 42 leads, 10 (23.8%) were right ventricular, 14 (33.3%) were atrial, 13 (31.0%) were defibrilator, and 5 (11.9%) were coronary sinus electrodes. The median time from implantation was 72 (18-216) months. Complete procedural success with TightRail™ system alone was achieved in 22 (95.7%) patients (41/42 leads) and overall clinical success was 100%. One right ventricular lead was completely removed with the help of femoral snare. All the patients were discharged uneventfully without any complication. Our preliminary data with small sample size show that TightRail™ Mechanical Dilator Sheath is a new useful tool for chronically implanted pacemaker (PM)/ICD leads. Continued investigation including large patient cohort is required to evaluate success and complication rates in comparison to other tools and techniques.

Transvenous extraction of an abandoned endocardial pacemaker lead in a dog

A 6-year-old male castrated labrador retriever presented with endocardial pacemaker infection following migration and subsequent repositioning of the pulse generator. An epicardial lead and pulse generator were surgically implanted and the endocardial lead could not be removed with manual traction. The endocardial lead was severed, anchored, and abandoned at the thoracic inlet. The patient presented 4 months later with endocardial lead migration, bacteremia, and suspected glomerulonephritis. The endocardial pacemaker lead was transvenously extracted using a mechanical dilator sheath and locking stylet. This report of transvenous pacemaker lead extraction in a dog addresses the challenges and describes recent advances in extraction devices.

Transvenous Rescue of Pacemaker Lead Fragments after Laser Extraction Failure

Transvenous lead extractions may be very challenging. Experience and a wide variety of extraction tools are essential in successfully managing such procedures. We report the case of a transvenous fragment extraction after an unsuccessful laser lead extraction procedure. it. The abandoned right atrial lead was intubated with a lead locking device (LLD EZ, Spectranetics, USA) and the fibrotic adhesions were dissected with a mechanical dilator sheath (Evolution, Cook Medical Inc., USA) facilitating complete extraction (Figure 1b). The operation was finished without complications. Microbiological examination showed that the extracted lead fragments were also positive for staphylococcus aureus, proving lead endocarditis. After an uneventful postoperative course the patient was discharged on the 6 th postoperative day. The antibiotic therapy was completed as planned and in compliance with the treatment guidelines of valvular endocarditis.

Advanced techniques for chronic lead extraction: heading from the laser towards the evolution system

The evolution mechanical dilator sheath has been reported to be an effective tool for chronic lead extraction (LE). We examined safety and efficacy of evolution system as compared with laser system. From 2005 to 2009, all extractions requiring the use of a powered sheath were performed using the excimer laser system (n = 73). Since 2009, laser system was no longer available and the evolution system was introduced as the first-line method for powered extraction (n = 48). All procedures were performed by a single first operator. Success and complications were defined according to the current guidelines. Patients of the evolution group compared with those of the laser group had a greater number of extracted leads per patient (2.77 vs. 2.4, P = 0.049) and a longer implant duration (101.1 vs. 62.4 months, P = 0.001). Additional use of snare was required in 27.1% of the evolution group and 8.2% of the laser group (P = 0.005). Complete procedural success was achieved in 91.7% of the evolution group and 97.3% of the laser group (P = 0.16). There was also no difference between evolution and laser groups in clinical success (97.9 vs. 98.6%, P = 0.76), as well as regarding major (4.2 vs. 2.7%, P = 0.66) or minor complications (4.2 vs. 5.5%, P = 0.76). Use of the recently introduced evolution system for LE exhibit acceptably high levels of safety, as well as of procedural and clinical success, although additional use of snare was required more frequently in the evolution compared with the laser group.

Materialization of ghosts: Severe intracardiac masses after pacemaker lead extraction requiring immediate surgical intervention

f d e Thirteen years after 2-chamber pacemaker implantation, a 50-year-old patient was referred for pacemaker lead extraction because of pocket infection. Lead extraction was performed with an 11-F Evolution Mechanical Dilator Sheath Set (Cook Medical, Inc, Bloomington, IN) in the operating theatre with cardiopulmonary bypass standby. The intraoperative preinterventional transesophageal echocardiography revealed no vegetations on the pacemaker leads. However, after complete extraction, an inhomogeneous highly mobile structure of 3.7 cm was seen in the right atrium, also referred to as “ghost” (Figure 1). Sudden cardiac death and symptomatic pulmonary embolism were reported as potential sequels. Because of the high mobility of this big structure, the decision for acute surgical intervention on cardiopulmonary bypass was made.

Evolution in Transvenous Extraction of Pacemaker and Implantable Cardioverter Defibrillator Leads Using a Mechanical Dilator Sheath

With developing technology, transvenous lead extraction (TLE) has undergone an explosive evolution due to incremental problems related to lead infection and malfunction. We aimed to present our experience in TLE with the Evolution®Mechanical Dilator Sheath (Cook Medical, Grandegrift, PA, USA). Between June 2009 and July 2011, the Evolution®mechanical dilator sheath was used for the extraction of 140 pacemaker (PM) and implantable cardioverter-defibrillator (ICD) leads in 66 patients. Indications for extraction, procedural success, and complications were defined according to Heart Rhythm Society Guidelines. Indications for TLE were infection in 39 patients (59.1%), lead malfunction in 26 patients (39.4%), and lead displacement in one patient (1.5%). Extracted devices were PM in 28 cases (42.3%), ICD in 26 cases (39.4%), and biventricular cardioverter defibrillator in 12 cases (18.2%). Among 140 leads, 31 (22.1%) were right ventricular, 49 (35.0%) were defibrillator coil, 47 (33.6%) were atrial, and 13 (9.3%) were coronary sinus electrodes. The median time interval from the lead implantation to lead extraction was 85 months (range 22-240 months). Complete procedural success with the Evolution®system alone was achieved in 58 (87.9%) patients and overall clinical success was 98.5%. Four leads were completely removed with the help of a femoral snare and partial success was achieved in three leads with a remaining small ventricular tip. Major complication was observed in only one (1.5%) patient without any mortality. Our experience confirms that the hand-powered Evolution system is an effective extraction tool for chronically implanted PM/ICD leads. Randomized controlled studies are required to evaluate success and complication rates in comparison to other techniques.

Use of the Mechanical Dilator Sheath for Removal of Endocardial Leads: A Single Center Experience

Due to an increasing number of cardiac device implantations, the number of leads that need to be extracted because of infection or lead failure is consistently rising. We present our experience in percutaneous lead removal in a single tertiary center. From December 2009 to August 2010, 12 patients underwent percutaneous lead extraction procedure by the Evolution™ mechanical dilator sheath (Cook Medical Inc., Bloomington, IN, USA) system after failure of manual traction and a locking stylet. Ages of the patients ranged between 7 and 86 years (mean age was 58 ± 12 years). Mean implantation time was 73 months (range between 12 and 244 months). Ten patients had one lead; only two patients had two leads. Indications for lead removal were: lead endocarditis in five patients, local (pocket) infection in four patients, and lead failure in three patients. All leads were successfully removed by using the device, except one lead which was one of the two leads in a patient with dual chamber pacemaker implanted 10 years ago. In three patients, same venous accesses (sheath of extraction system) were used to implant a new lead after removal of damaged leads without a new venous puncture. In only one patient, significant hematoma was found after the intervention and treated conservatively. No other significant complications were encountered in any patients. Damaged or infected leads can safely and relatively easily be extracted by using this new percutaneous extraction technique.