Lead Dwell Time Research Articles

The GermAn Laser Lead Extraction RegistrY: GALLERY.

The GermAn Laser Lead Extraction RegistrY: GALLERY is a retrospective, national multicentre registry, investigating the safety and efficacy of laser lead extraction procedures in Germany. Twenty-four German centres that are performing laser lead extraction have participated in the registry. All patients, treated with a laser lead extraction procedure between January 2013 and March 2017, were consecutively enrolled. Safety and efficacy of laser lead extraction were investigated. A total number of 2524 consecutive patients with 6117 leads were included into the registry. 5499 leads with a median lead dwell time of 96 (62-141) months were treated. The mean number of treated leads per patient was 2.18 ± 1.02. The clinical procedural success rate was 97.86% and the complete lead removal was observed in 94.85%. Additional extraction tools were used in 6.65% of cases. The rate of procedural failure was 2.14% with lead age ≥10 years being its only predictor. The overall complication rate was 4.32%, including 2.06% major and 2.26% minor complications. Procedure-related mortality was 0.55%. Female sex and the presence of abandoned leads were predictors for procedure-related complications. The all-cause in-hospital mortality was 3.56% with systemic infection being the strongest predictor, followed by age ≥75 years and chronic kidney disease. In the GALLERY, a high success- and low procedure-related complication rates have been demonstrated. In multivariate analysis, female sex and the presence of abandoned leads were predictors for procedure-related complications, while the presence of systemic infection, age ≥75 years, and chronic kidney disease were independent predictors for all-cause mortality.

Major procedure-related complications in a real-world cohort of patients undergoing transvenous lead extraction

Abstract Funding Acknowledgements Type of funding sources: None. Background Transvenous lead extraction (TLE) is the mainstay therapy for device-related infections. Though TLE procedures are associated with low complication and high success rates, risk factors for major procedure-related complications remain not well defined. Purpose To evaluate the safety and efficacy of TLE in a large single centre cohort and to identify risk factors for major complications. Methods All consecutive patients undergoing TLE in our department between May 2012 and December 2021 were included in a prospective registry. Our protocol for TLE followed a stepwise approach according to lead dwell time and estimated complexity of the procedure: use of simple traction ± locking stylet (LS) ± mechanical and/or powered sheaths ± snare technique via a femoral or jugular access. Patient characteristics, procedural data and complications were gathered and analysed. Logistic regression analysis was applied to identify risk factors for major procedure related complications. Results A total of 2218 leads (25.7% ICD leads) were targeted for TLE in 1060 patients (67.7 ± 14.8 years; 74% male). The mean lead dwell time was 82 ± 62 months. The leading indication for TLE was cardiac device related infection (CDRI) in 695 patients (65.6%), 373 (35.2%) had systemic and 322 (30.4%) localized infection. Leads were extracted by simple traction in 30%, traction with LS in 3.7%, dilator sheaths with LS in 47.7%, and additional use of powered mechanical sheaths in 14.6%. The snare technique was used in 3.9%, with additional venous entry from femoral in 3.5% and jugular in 1.0% of all targeted leads. TLE was completely successful in 92.6%, partially successful with lead fragments <4cm in 4.2%, and failed in 3.1% of all patients, which translated to a clinical success rate of 96.9%. Twenty-nine patients (2.7%) experienced minor and 18 patients (1.7%) had major procedure-related complications (cardiac tamponade/perforation) including 2 intraprocedural deaths (0.2%). Presence of abandoned leads (HR 8.41, 95% CI 3.21–22.02; p<0.001), lead-years-per-patient (HR 1.063, 95% CI 1.037–1.090; p<0.001), dwelling time of the oldest lead (HR 1.011, 95% CI 1.006–1.016; p<0.001), and a right-sided implantation (HR 2.68, 95% CI 1.05–6.83; p=0.04) were significant predictors of major complications in logistic regression analysis. Conclusion TLE is feasible, effective and safe in our large single centre experience. Overall complication and failure rates are low. Following our TLE protocol, the presence of abandoned leads, a right-sided implantation and dwelling time of the extracted leads were associated with major procedure-related complications.

Occluded vein as a predictor for complications in non-infectious transvenous lead extraction

Abstract Funding Acknowledgements Type of funding sources: None. Background Cardiovascular implantable electronic device (CIED) use is steadily increasing, with subsequent need to solve lead failure issues and device upgrades with an occluded vein. Transvenous lead extraction (TLE) has inherent risks that must be carefully weighed. Currently there is lack of conclusive data regarding many non-infectious indications. Methods A retrospective study on indications and outcomes of TLE for non-infectious reasons at our medical center, between the years 2011 to 2020 was performed. Occluded vein (OV) presence was compared for characteristics, extraction methods and periprocedural complications and outcomes. Results A total of 88 patients underwent TLE for non-infectious reasons. The majority were referred due to lead malfunction (70.5%) and CIED upgrade with an OV (25%), while 4 patients had other TLE indication (intractable pain, heart transplant, severe Tricuspid regurgitation, and irradiation). fourteen patients referred due to lead malfunction had an OV observed during venography. The OV group (36 patients) were significantly older (65.7±14.1 vs 53.8±15.9 respectively, p=0.001) and had more comorbidities. EF was significantly lower for the OV group (27.5% vs 57.5%, p=0.001) as was longer lead dwell time (3226±2324 vs 2191±1355 days, respectively, p=0.012). Major complications were exclusive for the OV group (16.7% vs none, p=0.02), and most minor complications occurred in the OV group as well (38.9% vs 4.1% respectively, p<0.001). Laser sheath and Mechanical tools for TLE were frequently used for OV as compared to the non-occluded group (94.4% vs 73.5% respectively, p=0.012). Procedure success was higher in the non-occluded group compared to the OV group (98% vs 83.3%, respectively, p=0.047). Despite these results, peri-procedural mortality was similar between groups. Conclusions Among TLE for non-infectious reasons, vein occlusion appears as a major predictor for complex TLE tools use, complications, and procedural success. Venography should be routinely performed prior to non-infectious TLE to identify high-risk patients.

PO-633-06 SAFETY AND EFFICACY OF TRANSVENOUS LEAD EXTRACTION IN PATIENTS WITH VERY LONG LEAD DWELL TIME

Tranvenous lead extraction (TLE) is an important component of lead management in patients with cardiac devices. Lead dwell time has been associated with increased procedural complexity and is often associated with a perception of increased risk. There is, however, limited data on the safety and outcomes of TLE in patients with leads of very long dwell times. Describe safety and outcomes of TLE in patients with leads with a very long (>= 20 years) dwell time. Patients undergoing TLE between 2013 - 2021 with at least one targeted lead with 20 years or more dwell time were identified from a single center prospective registry. Patient characteristics, outcomes, and 30-day major adverse events were collected. Clinical success of TLE was defined as the removal of all targeted leads and all lead material from the vascular space with less than 4 cm lead fragment residual that does not negatively impact either the patient or procedural goals. Lead-level analysis was summarized as number (percentage) for categorical variables and as mean ± standard deviation for continuous variables. Major adverse events related to TLE procedure, in accordance with HRS guidelines, within thirty days of the procedure were recorded. A total of 36 patients were included in the analysis with 71 leads of >= 20 years dwell time targeted for extraction. Mean patient age was 60.4 years (± 15.1) with the majority of patients having ≥2 indwelling leads. Included patients were predominantly male (64%) and Caucasian (86%). Indications included infection (25%), lead malfunction (32%); other indications including vascular occlusion and system revision made up the remaining 45% of cases. Among the 71 targeted leads, 94% were pacing leads and the mean dwell time was 25 years (±4.9 years). Initial applied tool was TightRail in 62% of cases and a laser sheath in 37% of cases. A femoral approach was ultimately required in 11% of cases. Clinical success was achieved in 90% of patients. There was one major adverse event, specifically vascular laceration requiring emergent sternotomy for repair. Leads with a very long (>=20 year) dwell time can be safely and successfully targeted for extraction. Further data from larger multicenter cohorts is needed to help guide optimal extraction strategies and patient selection.

Laser Lead Extraction During Venoarterial ECMO support.

The treatment of valvular endocarditis in patients with cardiac implantable electrophysiological device (CIED) includes valvular surgery and lead extraction. This can be challenging in patients with severely reduced left ventricular ejection fraction (LVEF). Reduced LVEF in combination with sepsis and cardioplegic cardiac arrest can make weaning from cardiopulmonary bypass difficult. Some of these patients require venoarterial extracorporeal membrane oxygenation (VA-ECMO) for postcardiotomy syndrome. Lead extraction by manual traction is often not possible in cases with a long lead dwell time. Therefore, a lead extraction procedure with powered sheaths is required during the VA-ECMO support. We describe our technique for laser lead extraction during VA-ECMO support in a 64-year-old patient with triple valve endocarditis and lead vegetations.

500 The impact on healthcare of reimplantation and long-term mortality after transvenous lead extraction in patients with device related infection

Abstract Aims Transvenous lead extraction (TLE) has become a pivotal part of a comprehensive lead management strategy, dealing with a continuously increasing demand. Nonetheless, literature about long-term outcomes and the impact of a new device implantation on survival is still lacking. Given these knowledge gaps, the aim of our study was to analyse reimplantation and both early and long-term mortality in patients undergoing TLE, even in a public health perspective, specifically clarifying concerns about reimplantation. Methods This prospective, single-centre, observational, real-world registry consecutively enrolled patients (pts) with cardiac implantable electronic device who underwent TLE at our Hospital, from January 2005 to September 2020. The primary endpoint was to analyse major adverse cardiovascular events (MACEs) in both re-implanted (R Group) and non reimplanted (NR Group); secondary end-point was long-term (after discharge) mortality of the whole cohort, in order to investigate long-term mortality predictors. Results We enrolled high-risk cohort of 451 pts (mean population age 70 ± 12, with lead dwelling time 81.7 ± 201.2 months) at baseline findings: 92% of pts had an evidence of device infection, a generally impaired heart function with mean left ventricular ejection fraction (LVEF) 44 ± 13% and high rates of comorbidities (15% of pts with hypertension+ diabetes mellitus + renal failure). Three-hundred thirteen (72%) pts were reimplanted, using endocardiac leads in 86% and epicardial leads in 14%. Total MACEs rate was higher in R Group versus NR Group (64% versus 28%, P ≤ 0.001, CI 95%, respectively). In particular, rehospitalizations occurred more frequently in reimplanted population (R group 43% versus NR group 13%, P = 0.001, CI 95%). Long-term mortality rate was 34% (150 pts) at a mean follow up of 5.2 years. The leading contributor to long-term mortality was represented by multiple non-communicable chronic diseases (62%), being sepsis responsible for only 4% of long-term mortality, with a clear evidence of reduced infective burden after TLE and complete antibiotic therapy. At multivariate analysis, we found three independent predictors of long-term mortality: advanced age (> 77 years, OR 1.04, CI 1.02–1.06, P < 0.001), renal failure (eGFR<30 mL/min, OR 1.66, CI 1.15–2.39, P = 0.007) and left ventricular dysfunction before TLE (LVEF<45%, OR 1.58, CI 1.08–2.13, P = 0.017). Conclusions In patients undergoing TLE for infective indications, our study identified the reimplantation group as high risk group for adverse events before discharge. On the other hand, advanced age, renal failure and systolic dysfunction, as independent predictors of long-term mortality, could be evaluated as a predictive score to assess the mortality risk before the procedure of TLE.

Abstract 10634: Out with the Old: Transvenous Extraction of Leads Older Than 15 Years

Background: Lead dwell time is the single strongest predictor of failure and complications in transvenous lead extraction. Objectives: To report the success rate and complications of transvenous lead extractions with implant dwell time of at least 15 years. Methods: Procedural and patient data were prospectively collected into a database. The excimer laser was the primary method for lead extraction with use of mechanical rotational sheaths and femoral snares at operator discretion. Results: A total of 443 patients between 2011-2020 underwent lead extraction (707 leads) primarily for infection or device failure at our high-volume center. 40 patients with 69 leads >15 years old were included in this cohort (Table 1). Mean patient age was 53.5 +/- 18.5 years, 67.5% were male. Mean lead dwell time was 19.3 +/- 4.2 years. 35 of 40 (87.5%) patients had successful extraction of all leads (62 of 69 leads - 89.9%). The 5 patients without fully successful extractions resulted in 7 abandoned leads or lead fragments (mean lead age 19.6 +/- 2.3 years). 2 of these patients had abandoned leads (3 total) that were clinically significant. One patient experienced right atrial appendage perforation requiring surgical repair and recovered well. One patient experienced new complete heart block requiring 2 minutes of CPR but did well thereafter. There was no procedure-related mortality. Conclusions: Despite challenges posed by older leads, very old leads can be safely and effectively extracted with low complication rates.

Abstract 13597: Poorer Outcomes Associated With More Invasive Lead Management Strategies for Abbott Riata® Leads in a Large, Multi-Center Retrospective Study

Introduction: Abbott Riata® (AR) leads are prone to conductor externalization but have similar annual failure rates compared to industry benchmarks. A recent multi-center study showed that lead extraction (LE), lead abandonment (LA), and generator change only (GC) have similar long-term outcomes for the recalled Sprint Fidelis® and AR leads when analyzed collectively. However, a study evaluating only AR lead management with these strategies has not been done. We sought to evaluate if outcomes are worse with more invasive strategies (LE and LA) vs. GC when managing AR leads. Hypothesis: To compare outcomes after LE, LA, and GC strategies for AR leads. Methods: This is a 5-center, retrospective study evaluating LE, LA and GC strategies for AR. The incidence of peri-procedural complications, 60-day extended or repeat hospitalization [ERHOSP], death within 60 days, subsequent lead malfunctions, and long-term mortality were compared amongst LE, LA, and GC strategies. Results: 165 patients (65± 13 years, 68% male) were followed for a mean 33 ± 30 months following intervention. Outcomes are listed on Table 1. Total AR lead dwell time follow-up was 16633 months. A total of 3 AR lead malfunctions were noted during long-term follow-up. Inappropriate shocks were similar between LE 7.7% (1/13), LA 6.3% (1/16) and GC 11.0% (15/136); P=0.74. Conclusions: More invasive lead management (LE and LA) resulted in increased death within 60 days and ERHOSP after adjusting for long-term lead malfunction with GC. Long-term mortality was also more favorable in the GC group. AR leads should only be extracted or revised if they demonstrate evidence of lead malfunction when the device reaches end of life.

Lead fixation mechanism impacts outcome of transvenous lead extraction: data from the European Lead Extraction ConTRolled Registry.

The aims of this study is to characterize the transvenous lead extraction (TLE) population with active (A) compared with passive fixation (PFix) leads and to compare the safety, efficacy, and ease of extracting active fixation (AFix) compared with PFix right atrial (RA) and right ventricular (RV) leads. The European Lead Extraction ConTRolled Registry (ELECTRa) was analysed. Patients were divided into three groups; those with only AFix, only PFix, and combined Fix leads. Three outcomes were defined. Difficult extraction, complete radiological, and clinical success. Multivariate model was used to analyse the independent effect of Fix mechanism on these outcomes. The study included 2815 patients, 1456 (51.7%) with only AFix leads, 982 (34.9%) with only PFix leads, and 377 (13.4%) with combined Fix leads. Patients with AFix leads were younger with shorter lead dwelling time. Infection was the leading cause for TLE among the combined Fix group with lowest rates among AFix group. No difference in complications rates was noted between patients with only AFix vs. PFix leads. Overall, there were 1689 RA (1046 AFix and 643 PFix) and 2617 RV leads (1441 AFix and 1176 PFix). Multivariate model demonstrated that PFix is independently associated with more difficult extraction for both RA and RV leads, lower radiological success in the RA but has no effect on clinical success. Mechanism of Fix impact the ease of TLE of RA and RV leads and rates of complete radiological success in the RA but not clinical success. These findings should be considered during implantation and TLE procedures.

Predictors and outcomes of TLE via femoral vein bailout

Abstract Background Transvenous Lead Extraction (TLE) is usually performed via a superior approach. Predictors and outcomes of TLE via femoral vein bailout are ill defined. Methods A single tertiary center cohort of 426 consecutive patients who underwent TLE between May 2010 and February 2020 were analyzed. Venography was routinely performed before system upgrade to identify occluded veins. Patients were divided into 2 groups on the basis of the need for femoral bailout extraction. Predictors for TLE requiring femoral bailout and outcomes were analysed. Results A total of 928 leads were extracted and femoral bailout approach was needed in 49 patients (11.5%). A higher proportion of RV leads required femoral bailout approach [51/499 (10.2%)]. Femoral bailout was more common among younger patients, longer lead dwell time, more pocket entries, higher number of extracted leads, presence of abandoned leads [14/49 (28.6%)], and among patients with occluded veins [10/22 (45.5%)]. The presence of abandoned leads, vascular occlusion and age remained a significant predictor for femoral bailout in multivariate analysis. Femoral bailout TLE resulted in a relatively higher rate of major complications [5/49 (10.2%) vs 9/377 (2.4%); p=0.02) but had no related intra-procedural mortality (0/3) and no additional 30 day mortality [2/49 (4.1%) vs 33/377 (8.8%); p=0.4]. Conclusion TLE of abandoned leads, occluded veins and younger age were found to be predictors of femoral bailout requirement. Despite higher rates of major complications in femoral TLE bailout this did not result in increased mortality. Venography before TLE should be considered for procedure planning. Funding Acknowledgement Type of funding sources: None.

A Study of Major and Minor Complications of 1500 Transvenous Lead Extraction Procedures Performed with Optimal Safety at Two High-Volume Referral Centers.

Background: Transvenous lead extraction (TLE) is the preferred management strategy for complications related to cardiac implantable electronic devices. TLE sometimes can cause serious complications. Methods: Outcomes of TLE procedures using non-powered mechanical sheaths were analyzed in 1500 patients (mean age 68.11 years; 39.86% females) admitted to two high-volume centers. Results: Complete procedural success was achieved in 96.13% of patients; clinical success in 98.93%, no periprocedural death occurred. Mean lead dwell time in the study population was 112.1 months. Minor complications developed in 115 (7.65%), major complications in 33 (2.20%) patients. The most frequent minor complications were tricuspid valve damage (TVD) (3.20%) and pericardial effusion that did not necessitate immediate intervention (1.33%). The most common major complication was cardiac laceration/vascular tear (1.40%) followed by an increase in TVD by two or three grades to grade 4 (0.80%). Conclusions: Despite the long implant duration (112.1 months) satisfying results without procedure-related death can be obtained using mechanical tools. Lead remnants or severe tricuspid regurgitation was the principal cause of lack of clinical and procedural success. Worsening TR(Tricuspid regurgitation) (due to its long-term consequences), but not cardiac/vascular wall damage; is still the biggest TLE-related problem; when non-powered mechanical sheaths are used as first-line tools.

Outcome of transvenous lead extraction of leads older than 20 years

In patients undergoing transvenous lead extraction (TLE), lead dwell time has been recognized as a risk factor for extraction failure and procedure-related complications. The aim of this study was to evaluate the safety and effectiveness of TLE in patients with pacemaker or ICD leads with a dwell time of ≥20 years. This is a single-center retrospective study of all patients who underwent TLE of at least 1 pacemaker or ICD leads a dwell time of ≥20 years. During the study period, 124 patients were included in this analysis (50.8% female, mean age: 74.6 ± 10.7 years). Device-related infection was the most common (92.7%) indication for TLE. Extraction was attempted for a total 313 leads, of which 182 leads had dwell times ≥20 years (median: 276 months; interquartile range: 255-300 months). Complete procedural success was achieved in 112/124 patients (90.3%), and clinical success in 119/124 patients (96.0%). Complete removal was achieved for 294 leads (93.9%), partial removal in 10 leads, and failure in 9 leads. Clinical success (combined complete and partial success) rates were higher for leads with dwell times <20 years compared to older leads (99.2% vs. 95.6%, p = .017). Major procedural complications (including 1 death) occurred in 7/124 patients (5.6%). Minor complications were observed in 8 patients (6.5%). TLE of very old (≥20 years) leads can be performed with reasonable success and safety when conducted at centers with expertise in lead management.

Analysis of Risk Factors for Major Complications of 1500 Transvenous Lead Extraction Procedures with Especial Attention to Tricuspid Valve Damage.

Background: Transvenous lead extraction (TLE) is a relatively safe procedure, but it may cause severe complications such as cardiac/vascular wall tear (CVWT) and tricuspid valve damage (TVD). Methods: The risk factors for CVWT and TVD were examined based on an analysis of data of 1500 extraction procedures performed in two high-volume centers. Results: The total number of major complications was 33 (2.2%) and included 22 (1.5%) CVWT and 12 (0.8%) TVD (with one case of combined complication). Patients with hemorrhagic complications were younger, more often women, less often presenting low left ventricular ejection fraction (LVEF) and those who received their first cardiac implantable electronic device (CIED) earlier than the control group. A typical patient with CVWT was a pacemaker carrier, having more leads (including abandoned leads and excessive loops) with long implant duration and a history of multiple CIED-related procedures. The risk factors for TVD were similar to those for CVWT, but the patients were older and received their CIED about nine years earlier. Any form of tissue scar and technical problems were much more common in the two groups of patients with major complications. Conclusions: The risk factors for CVWT and TVD are similar, and the most important ones are related to long lead dwell time and its consequences for the heart (various forms of fibrotic scarring). The occurrence of procedural complications does not affect long-term survival in patients undergoing lead extraction.

Transvenous lead extraction: The influence of age on patient outcomes in the PROMET study cohort.

Cardiac implantable electronic device (CIED) therapy contributes to an improvement in morbidity and mortality across all patient demographics. Patient age is a recognized risk factor for unfavorable outcomes in invasive procedures. This is the largest series of non-laser transvenous lead extraction (TLE) evaluating the association between patient age and procedure outcomes. Data of 2205 (3849 leads) patients was collected retrospectively from six European TLE centers between January 2005-December 2018 in the PROMET study. Of these, 153 patients with 319 leads were excluded for incomplete data. A comparison of outcomes was performed between the age groups young [<50 years], young intermediate [50-69 years], older intermediate [70-79 years], and octogenarian [≥80 years]. Infection was most common indication for TLE in the octogenarian cohort, less common in the younger population (60.1%vs. 33.2%, respectively, p<.01). High-voltage leads were extracted most frequently from young patients, less frequently from octogenarians (31.6%vs. 10%, p<.001), while the opposite was evident for pacemaker leads (p<.001). Rotational sheath use was equally prevalent across all patient groups (p=.79). Minor and major complications across all the age groups were statistically similar, as was procedural success; the 30-day mortality was most significant in the octogenarian and least in the young patients (4.9%vs. 0.4%, p=.005). Propensity matching multivariate analysis found systemic infection, lead dwell time, and patient age (p=.013, OR 1.064 [1.013-1.116]) increased risk of 30-day mortality. TLE is safe and effective across all age groups. 30-day mortality risk is significantly higher in the older patients.

Outcome of transvenous lead extraction in patients on minimally interrupted periprocedural direct oral anticoagulation therapy.

Direct oral anticoagulants (DOACs) have increasingly been used for several indications for systemic anticoagulation in patients with cardiac implantable electronic devices (CIEDs). The optimal management of anticoagulation therapy in patients undergoing transvenous lead extraction (TLE) procedures remains uncertain. The aim of this study was to evaluate the feasibility and safety of TLE during minimally interrupted DOAC therapy. This is a single-center retrospective study of all patients who underwent TLE of a pacemaker or implantable cardioverter-defibrillator lead while on DOAC therapy. In patients deemed to be at high thromboembolic risk, the last DOAC dose was administered the morning of the day before the procedure (regardless of the type of DOAC) and was restarted as soon as possible after the procedure, without bridging with parenteral anticoagulation. During the study period, a total of 84 patients underwent TLE while on minimally interrupted DOAC therapy (54% female, mean age: 74 ± 12 years). TLE was attempted for 161 leads, with a median lead dwell time of 61 months (interquartile range, 38-101). Complete procedural success was achieved for 156 leads (96.9%) and partial success for additional two leads (1.2%). One patient developed RV perforation and required pericardiocentesis and blood transfusion, but no surgical repair. Two patients developed pocket hematomas requiring invasive evacuation. No systemic or venous thromboembolic events were observed. There was no in-hospital mortality. In selected CIED patients at high risk for thromboembolism, TLE during minimally interrupted DOAC therapy may be considered when performed at experienced centers.

B-AB02-03 INTRACARDIAC ECHOCARDIOGRAPHY DURING TRANSVENOUS LEAD EXTRACTION TO AVOID INJURY TO THE TRICUSPID VALVE

Minimal data exist regarding tricuspid valve (TV) damage during transvenous lead extraction (TLE). Most studies have been performed with transesophageal echocardiography. Assess incidence of TV injury during TLE with intracardiac echocardiography (ICE) and determine if ICE can change procedural strategy. Single center, prospective analysis of consecutive patients undergoing TLE of right ventricular (RV) leads. TR assessed pre/post with ICE using a mild/moderate/severe/torrential grading system. 71 patients (mean age 59.4±14.8, 66% male) included. Average of 1.04 leads (68.9% ICD) removed with average lead dwell time of 106.7±69.9 months. Thrombi/vegetations seen ≥1 lead in 45 (63%) cases. Dense adhesions noted in 21 (28%) patients including RV(11), TV(5), RV papillary muscle(3) Eustachian ridge(1), and superior vena cava(1). Procedural strategy changed in 13/21 cases including ICE monitoring of bound segment during TLE to avoid avulsion(7), upsizing sheath(2), snaring from below(1) and aborting the procedure(3). TR grade changed in 2 cases (mild to moderate and moderate to severe). There were two TV injuries. First was a partial flail leaflet after removal with gentle traction (no change to baseline torrential TR). Second was a flail leaflet (increase from moderate to severe TR) in a patient with clear adhesion to the papillary muscle despite advancing sheath to lead tip. Thirty-two percent had lead casts in the RV or within the TV after TLE. Significant increase in TR is rare during TLE with an incidence of 2.8% in our series. ICE changed management in a significant number of patients possibly decreasing risk of complication.

Technical Features and Clinical Outcomes of Coronary Venous Left Ventricular Lead Removal and Reimplantation.

The number of patients undergoing cardiac resynchronization therapy has increased. Consequently, there is increased frequency in the removal and reimplantation of coronary venous (CV) leads due to infection or malfunction. A total of 345 consecutive patients referred for lead(s) extraction were reviewed. Of these, 34 patients who underwent a CV lead removal were investigated. The indications for CV leads removal were device-related infections in 29 patients and lead malfunctions in 5 patients. The average duration of the CV leads was 4.1±3.8 years. All CV leads were successfully removed without any major complications, except for 1 in-hospital death. Successful CV lead removal by simple traction (ST) was achieved in 21 patients (62%), whereas extraction tools were required in 13 patients (38%). Local infection and CV lead dwell time were significantly associated with successful ST (P=0.04 and P=0.014, respectively). CV lead re-implantation was successfully performed in 25 patients; however, a right-side approach was required in 92%, and occlusion/stenosis of the previous CV was observed in 80% of the patients. CV lead removal is relatively successful and safe. The presence of local infection and a shorter lead duration may enable successful ST of a CV lead. However, the re-implantation procedure should be well prepared for the complexity related to the right-side approach and occlusion/stenosis of the previous CV.

Submuscular reburial as an alternative to lead extraction in high risk patients

Abstract Funding Acknowledgements Type of funding sources: None. Background The Heart Rhythm Society (HRS) and European Heart Rhythm Association (EHRA) consensus states complete extraction is recommended for all patients with definite cardiac implantable electronic device (CIED) infection. Although complete removal of hardware is the best way to manage infections, lead extraction is a complex procedure with significant risk. As age and complexity of patients increase so too does extraction risk. In very high risk cases conservative management is cited, though little is known on outcomes. Purpose We are a high volume tertiary centre which serves a population of 2 million. 2 experienced operators perform 65 extraction procedures per year for the past 10 years. We report our experience of device reburial as initial management of CIED pre-erosion and erosion in cases deemed too high risk for extraction. Method We retrospectively reviewed all reburial procedures undertaken over 9 years. Patient and lead factors influencing decisions were assessed. Information on number of leads, dwell time, prior procedure, infective status and comorbidity was collated. The outcomes included morbidity, defined by repeat procedure (revision and/or extraction) and mortality. Results 86 patients underwent 96 procedures from March 2013 until August 2020. All patients undergoing device reburial were included. 55.8% of patients were male, mean age was 73. 21 patients died, 7 of these deaths occurred within 12 months of the index reburial procedure. The mean follow up period was 39 months (range 5–90). 65.1% of patients had a procedure (de novo implant, upgrade or replacement) within 12 months prior to revision. We reviewed patients in 2 subgroups based on revision indication – erosion and pre-erosion. Erosion was defined as externalised lead/device. Pre-erosion was defined as superficial device with skin tethering but no exposure. The former is a definite indication for lead extraction, the latter a relative indication. All in the pre-erosion group were systemically well with no infection evident. One patient with erosion had a positive blood culture. The mean age in the erosion group was 85 years with a Clinical Frailty Score (CFS) 4.98 and lead dwell time 17.87 years compared to age 68 years, CFS 3.98 and dwell time 8.14 years in the pre-erosion group. Patients in this cohort with an eroded device were deemed too high risk to undergo transvenous lead extraction. A higher proportion of patients presenting with erosion died within 12 months of the index reburial procedure (16.67% vs 4.84%). 21% with an eroded device and 11% with a pre-eroding device undergoing reburial as first line management required future extraction. Conclusion Our 9 year data suggests less invasive intervention is a valid option in high risk groups such as older age, frailty, long lead dwell time, with an acceptable incidence of reintervention and/or extraction. This data can help guide informed consent in the future.

PROMET: The effect of operator profession on non-laser transvenous lead extraction

Abstract Funding Acknowledgements Type of funding sources: None. OnBehalf PROMET group Background As implantation of cardiac implantable devices (CIED) rises globally, there is a paralleled need for extraction of these devices. Indications for transvenous lead extraction (TLE) is expanding, fuelling demand. This lifesaving procedure is performed by cardiologists and cardiac surgeons (CS). Cardiologists are familiar with transvenous methods whilst cardiac surgeons possess the skillset to address the significant complications associated with this procedure. We compared non-laser TLE outcomes performed by cardiologists and cardiac surgeons from six high-volume extraction centres across Europe. Methods Data was collected retrospectively from six major European TLE centres of 2205 patients and 3849 leads (PROMET). Propensity 1:1 score matching (PSM) was performed to account for confounding variables. PSM model with variables: lead dwell time, infection indication, biventricular system and defibrillator device, was best matched. This dataset was analysed to compare outcomes of TLE performed by the cardiologists and CS. Predictors of 30-day mortality and complications were identified using a multivariate regression analysis. Results Patients treated by CS and cardiologists were similar in age (64.7 vs 66.7 years, p = NS) and equally male (70.3% vs 72.3%, p = 0.39) with a parallel infectious indication (51.7% vs 47.6%, p = 0.1). Surgeons achieved a significantly higher proportion of clinical success than cardiologists (98.9% vs 96.4%, p = 0.001) and complete lead extraction (98% vs 95.9%, p &amp;lt; 0.01) with a higher rate of minor complications (4.1% vs 2.2%, p = 0.024); major complications were similar (0.9% vs 1.2%, respectively, p = 0.46) as was 30-day mortality (3.2% vs 2%, respectively, p = 0.28). Multivariate regression analysis revealed systemic infection (p &amp;lt; 0.001, OR 7.2 [CI 2.3-20.1]) and defibrillator system extraction (p = 0.025, OR 3.4 [CI 1.2-10.2]) increased the odds of 30-day mortality, whilst Evolution™ sheath use reduced the odds (p = 0.025, OR 0.34 [CI 0.13-0.88]); lead dwell time (p = 0.02, OR 1.005 [1-1.009] and Evolution™ sheath use (p = 0.023, OR 2.15[1.1-4.15]) increased the odds of complications. Conclusion Cardiac surgeons and cardiologists achieved a high rate of TLE procedural success and with a similar safety profile, replicating standards seen across Europe.

PROMET: the effect of age on patient outcomes in non-laser transvenous lead extraction

Abstract Funding Acknowledgements Type of funding sources: None. OnBehalf PROMET group Background Cardiac implantable electronic devices (CIEDs) improve morbidity and mortality. This has fuelled an upsurge in implantation of these devices across all patient cohorts, simultaneously increasing the need for transvenous lead extractions (TLE). As the global population expands and life-expectancy extends, TLE will play a significant role in CIED management. Advancing patient age is a recognised risk factor for poor outcomes however the association between patient age and TLE outcomes remains unclear. We sought to evaluate the relationship between patient age and non-laser TLE outcomes. Method Data of 2205 patients (3849 leads) was collected retrospectively from six high-volume TLE institutes across Europe (PROMET) between January 2005-December 2018. Propensity 1:1 score matching was performed to limit the effects of confounding variables, pairing 353 patients in the &amp;gt;80 years of age category with 353 patients in &amp;lt;80 years of age group. Procedural outcomes were compared between the two age groups and multivariate regression analysis was used for predictors of 30-day mortality. Results In the &amp;lt;80 and &amp;gt;80 years-of-age cohorts, there was a similar proportion of male patients (65.3% vs 67.9%, p = 0.47) treated under general anaesthesia (96.5% vs 93.4%, p = 0.078) for a pre-dominant infectious indication (56.7% vs 60.3%, p = 0.52) but with a higher requirement of the EvolutionTM sheath in the octogenarians (39.4% vs 48.4%, p = 0.015). A similar clinical success per lead was achieved between the two age groups (96.6% vs 98%, &amp;lt;80 vs &amp;gt;80 years, p = 0.245) as was complete lead extraction (95.5% vs 96.6%, &amp;lt;80 vs &amp;gt;80 years, p = 0.44) with a comparable minor complication rate (2.3% vs 3.1%, &amp;lt;80 vs &amp;gt;80 years, p = 0.29) and major complications (1.1% vs 1.4%, &amp;lt;80 vs &amp;gt;80 years, p = 0.74). Thirty-day mortality was higher in the octogenarian cohort than the &amp;lt;80-year-olds without reaching statistical significance (5.4% vs 2.6%, p = 0.08); peri-procedural mortality was similar in both age groups (0.3% vs 0.6%, respectively, p = 0.56). Multivariate regression analysis revealed age (p = 0.013, OR 1.06 [1.01-1.12]), systemic infection (p = 0.026, OR 3.4 [1.16-10.35]) and lead dwell time (p = 0.007, OR 1.01 [1.003-1.017]) increased the odds of 30-day mortality. Conclusion Transvenous lead extraction is similar in efficacy and safety across all age groups. Thirty-day mortality is higher in the advanced age group, signifying the importance of post-procedural management in this cohort.