Lead Dwell Time Research Articles

Minimally Invasive Techniques to Avoid Sternotomy in Complex Lead Extraction Cases.

Cardiac device lead extractions have increased in frequency over the past several years. Although most of these procedures are successfully performed through a percutaneous approach, certain cases may be unmanageable using conventional methods. The traditional approach for such complex cases has been median sternotomy. However, four surgical techniques offer a less-invasive alternative. These include the transatrial approach, the subxiphoid approach, the left minithoracotomy/thoracoscopy, and the ministernotomy. In the present study, we reviewed data from patients who underwent minimally invasive, surgical lead extraction at our institution from January 2003 to October 2017 using an ongoing, prospective registry. Summary statistics were generated for age, sex, device extracted, lead dwell time (years), procedure indication, major/minor complications and procedural success as defined by the 2017 Heart Rhythm Society consensus statement, and survival at discharge. Between January 2003 and October 2017, 14 cases at our center were managed via a transatrial approach, whereas 11 involved the subxiphoid approach, 19 involved a left minithoracotomy or thoracoscopy, and one involved a ministernotomy. For the transatrial approach, all cases were classified as procedural successes and all patients were discharged alive. Additionally, for the subxiphoid approach, all cases were deemed procedural successes, whereas survival at discharge was 90.9%. For the left minithoracotomy/thoracoscopy, all cases were procedural successes and survival at discharge was 94.7%. Lastly, the ministernotomy was successfully used to remove an infected, retained lead fragment from the innominate vein. In conclusion, at our institution, the transatrial approach, the subxiphoid approach, the left minithoracotomy/thoracoscopy, and the ministernotomy were used as minimally invasive, surgical approaches that represent fairly safe and effective alternatives to median sternotomy in complex cases unamenable to management via conventional, percutaneous approaches to lead extraction.

Procedural outcomes associated with transvenous lead extraction in patients with abandoned leads: an ESC-EHRA ELECTRa (European Lead Extraction ConTRolled) Registry Sub-Analysis.

The decision to abandon or extract superfluous leads remains controversial. We sought to compare procedural outcome of patients with and without abandoned leads undergoing transvenous lead extraction (TLE). An analysis of the ESC-EHRA European Lead Extraction ConTRolled ELECTRa registry was conducted. Patients were stratified into two groups based on the presence (Group 1) or absence (Group 2) of abandoned leads at the time for extraction. Out of 3508 TLE procedures, 422 patients (12.0%) had abandoned leads (Group 1). Group 1 patients were older and more likely to have implantable cardioverter-defibrillator devices, infection indication (78.8% vs. 49.8%), and vegetations (24.6% vs. 15.3%). Oldest lead dwelling time was longer in Group 1 (10.9 vs. 6.3 years) as was the number of extracted leads per patient (3.2 vs. 1.7). Manual traction failure (94.5% vs. 78.8%), powered sheath use (50.7% vs. 28.4%), and femoral approach were higher in Group 1 (P < 0.0001). Procedural success rate and clinical success (89.8% vs. 96.6%, P < 0.0001) were lower in Group 1. Major complication including deaths (5.5% vs. 2.3%, P = 0.0007) and procedure related major complications (3.3% vs. 1.4%, P = 0.0123) were higher in Group 1. The presence of abandoned leads at the time of TLE was an independent predictor of clinical failure [odds ratio (OR) 2.31, confidence interval (CI) 1.57-3.40] and complications [OR 1.69, CI 1.22-2.35]. receiver-operating characteristic curve analysis showed a dwell time threshold of 9 years for radiological failure and major complications. Previously abandoned leads at the time of TLE were associated with increased procedural complexity, clinical failure, and major complication, which may have important implications for future studies regarding managing of lead failures.

Eficacia, seguridad y factores predictores de complicaciones de la extracción de electrodos cardiacos con láser de excímeros

Introduction and objectivesThe increase in the insertion rate of cardiac implantable electronic devices (CIED) in the last decade has given rise to the need for transvenous lead extraction (TLE) techniques, and frequently in high-risk patients. The aim of this study is to evaluate the success rate of the procedure and the clinical success rate of laser-facilitated TLE, as well as to determine the incidence of cardiovascular complications, their management, and outcome. MethodsA total of 94 consecutive patients undergoing TLE of CIED between June 2008 and July 2018 were included in the analysis. ResultsA total of 170 (69 auricular and 101 ventricular) leads were extracted with a median lead implant duration of 81 months (range 16-246 months). More than two-thirds (69.1%) of the patients had leads older than 5 years, and 36.2% of the patients had anomalies in the patency of the upper extremity veins. The procedure success rate and clinical success rate were 96.8% and 97.9%, respectively. There were 6.4% of major cardiovascular complications and one in-hospital death. Bivariate analysis suggested, as risk factors for major cardiovascular complications, lead dwell time, dual-coil defibrillator leads, and complete occlusion of the ipsolateral upper limb veins. In-hospital mortality of patients requiring emergency surgical or endovascular repair for a major cardiovascular complication was 16.7%. ConclusionsLaser-assisted TLE of CIED has a remarkable safety and effectiveness, even in high-risk patients. Major cardiovascular complications are uncommon, but are associated with a high mortality. Early identification and treatment is mandatory for patient survival.

Transvenous lead extraction in patients with cardiac resynchronization therapy devices is not associated with increased 30-day mortality.

Transvenous lead extraction (TLE) may be necessary due to system infection/erosion or lead malfunction. Cardiac resynchronization therapy (CRT) patients undergoing TLE may be at greater risk due to increased comorbidities. We examined whether patients with CRT systems undergoing TLE had more comorbidities and higher 30-day mortality than those with non-CRT devices. All TLEs between October 2000 and December 2016 were prospectively collected. During this period 925 TLEs occurred (CRT group 231, non-CRT group 694). Cardiac resynchronization therapy patients were older (68.1 ± 10.8 years vs. 64.3 ± 16.1 years, P = 0.024); more likely male (85.7% vs. 69%, P < 0.001); had lower mean left ventricular ejection fraction (34.1 ± 12.7% vs. 48.3 ± 12.9%, P < 0.001); had higher prevalence of renal impairment (33.8% vs. 13.7%, P < 0.001) and were more likely to have ≥2 comorbidities (84% vs. 40.1%, P < 0.001). Mean lead dwell time was lower in the CRT group (5.6 ± 5.5 years vs. 7.6 ± 7.1 years, P = 0.002). There was no significant difference in all-cause 30-day mortality rates between CRT (3.0%, n = 7) and non-CRT patients (2.0%, n = 14) (P = 0.443). The majority of deaths in both groups were due to sepsis. Univariate and multivariate analysis showed age, renal impairment and sepsis were associated with increased risk of 30-day mortality. Transvenous lead extraction of a CRT system did not predict 30-day mortality. Transvenous lead extraction in CRT patients was not associated with increased 30-day mortality when compared with non-CRT patients. Age, renal impairment and sepsis were independent predictors of 30-day mortality. Sepsis was the main cause of 30-day mortality.

Risk Factors Predicting Complications of Transvenous Lead Extraction.

Objective Transvenous lead extraction (TLE) is the gold standard in the management of patients with cardiac implantable electronic devices (CIED)-related complications. Knowledge of TLE risk factors is very important. Methods Clinical data from 1915 patients undergoing TLE at the Reference Center between 2006 and 2015 were analyzed. The effects of clinical and procedure-related factors on the development of major (MJC) and minor (MIC) complications and survival after TLE were evaluated. Results MJC were caused mainly by lead implant duration, presence of abandoned leads, multiple procedures preceding TLE, and any technical problem during TLE. Of clinical factors female gender and anemia increased the risk of MJC. MIC were reported in patients with the first implantation of CIED under the age of 30 and after sternotomy analysis of 30-day survival after procedure demonstrated a significant effect of clinical factors and lead dwell times, previous unsuccessful TLE, and MIC. Conclusions Efficacy and safety of TLE depend mainly on procedure-related factors. This knowledge is essential for preventing MJC and MIC. Mortality at 30 days following TLE is mainly associated with the clinical factors; however, there was also a significant effect of lead dwell time and periprocedural complications on the short-term prognosis of patients undergoing TLE.

Outcomes of video-assisted thoracoscopic surgery for transvenous lead extraction.

To evaluate the outcomes of video-assisted thoracoscopic surgery (VATS) during transvenous lead extractions (TLEs). Ninety-one high-risk patients who underwent TLE in the operating room from January 1, 2015, to March 31, 2017, were included in the study. Of these, 9 patients underwent VATS during TLE. Their clinical characteristics, indications for lead extraction, and complications associated with TLE in the 9 patients who had VATS were compared with those for the 82 patients who did not have VATS. The mean (SD) age of the study patients was 61 (17) years (64.8% were male). The lead dwell time, number of leads extracted, and clinical comorbidities were similar between the 2 groups. Superior vena cava (SVC) tear occurred in 2 of the 9 patients in VATS group and in 1 of the 82 in the non-VATS group (22.2%vs. 1.2%, P=0.03). Of the 2 patients in the VATS group who had SVC tears, in 1 the tear was visualized immediately and there was no hemodynamic compromise. In the other patient, the SVC tear was within the pericardium; the blood pressure recovered quickly after sternotomy and repair. Both patients had complete lead extraction and survived hospitalization. The patient in the non-VATS group who had an SVC tear had a successful repair but died of postoperative complications. Utilization of VATS to facilitate TLE is beneficial for early recognition of SVC tear and timely surgical repair in select high-risk patients.

Simultaneous lead traction from above and below: A novel technique to reduce the risk of superior vena cava injury during transvenous lead extraction

Superior vena cava (SVC) injury is a rare but dreaded complication during percutaneous transvenous lead extraction (TLE) that carries high morbidity and mortality. Despite technological advances and improved efficacy, complication rates remain unchanged. We sought to develop and test a novel technique that could reduce the risk of SVC injury during TLE. Fifteen patients referred for TLE of an implantable cardioverter-defibrillator lead were included. Patients underwent fluoroscopic and intracardiac echocardiographic (ICE) imaging of the lead-SVC interface with traction from above, below, and simultaneously. Clinical characteristics, fluoroscopic and ICE findings, and procedural outcomes were collected and analyzed. Fourteen of 15 patients were men (93%) with a mean ageof 58 years. The mean lead dwell time was 8.09 ± 3.97 years (range 1.08-16.25 years), and 12 of 15 leads (80%) were dual-coil. Acceptable ICE imaging was not possible in 3 of 15 patients (20%). Simultaneous traction showed greater leftward fluoroscopic shift compared with traction from above (24.96 ± 8.82 mm vs 13.68± 6.86 mm; P < .01), created greater separation between the lead and the SVC wall upon ICE imaging (2.0 ± 0.52 mm vs 1.24 ± 0.38 mm; P < .01), and maintained a more parallel relationship of the lead with the SVC wall (24.41° ± 4.14° vs 27.91° ± 4.92°; P< .05). In patients presenting for TLE, simultaneous traction results in increased separation and a more parallel alignment of the lead and SVC wall, allowing the sheath to be better oriented in the desired cleavage plane. This improved sheath alignment is particularly critical when powered sheaths are to be used.

New onset of phrenic nerve palsy after laser-assisted transvenous lead extraction: a single-centre experience.

Phrenic nerve palsy (PNP) after mechanical transvenous lead extraction (TLE) was recently described for the first time. We aimed to analyse our TLE database for the presence of PNP. All consecutive patients referred to our institution were included in this study. Every available post-procedural chest X-ray was compared to the routinely performed pre-procedural radiographs. A newly elevated hemidiaphragm ipsilateral to TLE was considered indicative of PNP. Altogether 255 TLE procedures with extraction of 364 leads were performed. Most common TLE indication was lead malfunction (63%). Complete radiographic success rate was 97.3% with an in-hospital procedure-related major complication rate of 2.4%, including one intra-procedural death (0.4%). We identified five cases with PNP (2%), all occurring after laser-assisted TLE. Clinical presentation varied from subtle and aspecific chest pain/discomfort to severe and acute dyspnoea, with time to diagnosis varying from immediate to several weeks after the procedure. In 80% of cases, the explanted lead was a defibrillator electrode and the median lead dwelling time was 70.2 months (29.3; 1084.9). In four cases, the extraction was performed using high-energy laser (pulse repetition rate 80 Hz). The present study reports the incidence of PNP after laser-assisted TLE. We postulate that the thermal energy generated by laser is not dissipated quickly enough in occluded or heavily calcified lesions, injuring the ipsilateral phrenic nerve. Our findings advise to carefully consider to increase pulse repetition rate at the subclavian level. Larger, possibly prospective studies are needed to evaluate the real incidence through systematic radiological assessment after TLE.

Transvenous Lead Extraction in Chronic Kidney Disease and Dialysis Patients With Infected Cardiac Devices.

Cardiac implantable electronic device infections have been on the rise. A high-risk population is that with renal disease, especially dialysis. We aimed to assess procedural profiles and clinical outcomes of transvenous lead extraction for cardiac implantable electronic device infection based on renal disease status. In 1420 consecutive patients undergoing transvenous lead extraction of infected cardiac implantable electronic devices (1996-2012), we assessed procedural profiles and clinical outcomes in 3 groups: normal renal function (group 1, n=1159), renal dysfunction not requiring dialysis (group 2, n=163), and dialysis (group 3, n=98). A total of 3182 infected leads were extracted. Dialysis patients had shorter lead dwell times and were less likely to require transvenous lead extraction tools but as likely to require femoral workstations. There were higher overall rates of procedure-related complications in dialysis patients (12% versus ≈6% in nondialysis) with no difference in the major complication rates (P=not significant). Complete procedural success rates were 94%, 96%, and 94% in groups 1, 2, and 3, respectively (P=not significant). There were 4 intraprocedural deaths in group 1 versus none in groups 2 and 3. Mortality rates were significantly higher in dialysis patients both at 1 and 6 months (P<0.0001 for both). In multivariable analyses, dialysis status was independently associated with increased mortality risk at 1 and 6 months. Other factors associated with mortality were lead material retention, functional (New York Heart Association) class, and occurrence of procedural complications. In patients with cardiac implantable electronic device infection, dialysis status did not seem to add complexity to transvenous lead extraction but was independently associated with increased mortality at 1 and 6 months.

Canadian Registry of Implantable Electronic Device Outcomes: Longer-term follow-up of the Riata lead under advisory

The Riata lead advisory was announced in 2011 and has posed unique management challenges because of cable externalization and insulation abrasion, in some cases leading to sudden loss of defibrillation. The purpose of this study was to provide further data on the rate of electrical failure in a population of patients with a Riata lead under advisory. Using the Canadian Registry of Electronic Device Outcomes, prospective follow-up data were collected on 1352 Riata leads under advisory in 17 implantable cardioverter-defibrillator (ICD) implantation centers in Canada. Data on electrical and structural failure were collected, as well as periprocedural complications related to lead revision (abandonment or extraction). Of the 1352 leads included in this 12-month follow-up cohort, 110 leads were revised. Mean follow-up time was 10.4 ± 1.5 years. The 12-year rate of electrical failure for the 8Fr lead was 9.45%, whereas the 10-year failure rate for the 7Fr lead was 7.25% and was not found to be accelerating. Of the leads revised because of advisory only (patient preference, advisory related, electrical or structural failure), the majority were abandoned (n = 54 [76.0%]), whereas 17 (24.0%) were extracted using power tools. The rate of major complications in each group was 5.6% and 5.9%, respectively. This report provides further data on the risk of electrical lead failure over a long lead dwell time. The risk of failure exceeds the risk of periprocedural major complications, indicating that the risk-to-benefit ratio is favorable to revise the lead in appropriate clinical scenarios.

Long-term outcomes of prophylactic placement of an endovascular balloon in the vena cava for high-risk transvenous lead extractions

Many clinicians use the strategy of prophylactically placing an endovascular balloon before transvenous lead extraction, yet there are no data regarding this practice. This study assesses long-term outcomes of prophylactic placement of an endovascular balloon in the venae cavae of patients during transvenous lead extraction. From April 1, 2016 to March 31, 2017 data were prospectively collected at 2 international cardiovascular centers on patients who had the balloon prophylactically placed in the venae cavae. Patients were monitored for a minimum of 3 months to capture any associated adverse events. Twenty-one patients had the balloon prophylactically placed in the venae cavae during lead extraction. Sixteen patients were male (76%); the mean age was 57.6 ± 18.7 years; and the mean body mass index was 26.1 ± 4.4 kg/m2. The mean lead dwell time was 11.2 ± 8.3 years, with an average of 2.2 ± 1.1 leads per case, and most indications for extraction were noninfectious (62%). Two minor complications (10%, pocket hematomas) and 1 major complication (5%, cardiac tamponade) occurred during the procedure. All cases (100%) were procedural successes, and all patients (100%) were discharged alive. On follow-up (6.8 ± 3.7 months), all patients were alive and reported no adverse events related to prophylactic balloon placement, such as pulmonary emboli or deep venous thrombi. During the study period, we observed no acute or long-term adverse outcomes associated with prophylactic placement of an endovascular balloon in the venae cavae of patients undergoing transvenous lead extraction.

Outcomes of lead extraction in young adults

Extraction of pacemaker and defibrillator leads in young adults may be technically challenging because of more extensive fibrosis and calcification in this patient population. The purpose of this study was to examine outcomes of lead extraction (LE) in young adults at our institution. We retrospectively identified all patients who underwent LE at our institution between January 1, 2007, and May 31, 2016. Patients were divided by age into 2 groups: <40 years (group 1, n = 84) or ≥40 years (group 2, n = 690). Outcomes were determined by medical records review. Patients in group 2 had a higher overall average number of leads extracted per procedure compared to group 1 (1.64 ± 0.80 vs 1.45 ± 0.64; P <.001). Lead dwell time was similar in the 2 groups (5.7 ± 5 years vs 5.6 ± 4.3 years; P = .95). The younger cohort tended to require femoral extraction techniques more frequently (9.5% vs 4.4%; P = .055). Extraction procedural success (group 1: 94.1%, group 2: 94.9%; P = .792), major complications (group 1: 0%, group 2: 1.3%; P = 1), and periprocedural mortality (group 1: 0%, group 2: 0.86%; P = 1) were similar in the 2 groups. LE can be performed safely and effectively in young adults. Despite the lower number of leads extracted per procedure and the similar lead dwell time, younger adults more frequently required the use of femoral extraction tools, thus highlighting the importance of performing these procedures in centers with advanced expertise in extraction techniques.

Predictors and outcomes of lead extraction requiring a bailout femoral approach: Data from 2 high-volume centers

Lead extraction (LE) infrequently requires the use of the "bailout" femoral approach. Predictors and outcomes of femoral extraction are not well characterized. The aim of this study was to determine the predictors of need for femoral LE and its outcomes. Consecutive patients who underwent LE at our centers were identified. Baseline demographic characteristics, procedural outcomes, and clinical outcomes were ascertained by medical record review. Patients were stratified into 2 groups on the basis of the need for femoral extraction. A total of 1080 patients underwent LE, of whom 50 (4.63%) required femoral extraction. Patients requiring femoral extraction were more likely to have leads with longer dwell time (9.5 ± 6.0 years vs 5.7 ± 4.3 years; P < .001), to have more leads extracted per procedure (2.0 ± 1.0 vs 1.7 ± 0.9; P = .003), and to have infection as an indication for extraction (72% vs 37.2%; P < .001). Procedural and clinical success was lower in the femoral extraction group than in the nonfemoral group (58% and 76% vs 94.7% and 97.9 %, respectively; P < .001). Major periprocedural complications (0% vs 1.3%; P = 1.0) and periprocedural mortality (0% vs 0.8%; P = 1.0) were similar between the 2 groups. In this study, femoral extraction was needed in ~5% of LEs. Longer lead dwell time, higher number of leads extracted per procedure, and the presence of infection predicted the need for femoral extraction. Procedural success of femoral extraction was low, highlighting the fact that this approach is mostly used as a bailout strategy and thus selects for more challenging cases.

96-54: Transvenous lead extraction in old patients – safety &amp; effectiveness. Single center experience among 2022

There is considerable controversy regarding safety of transvenous lead extraction (TLE) in elderly patients due to theirs potentially worse general condition, more concomitant diseases and more difficult sedation / analgesia and current experience is not so big. Objective: The comparison of safety and feasibility of TLE in very old and middle age pts. Methods: Using standard mechanical systems we have extracted ingrown PM/ICD leads from 1917 middle age pts (30-79-y), 284 octogenarians (80-90-y) and 15 nanogenarians (>90-y) within the last 10 years. We compared effectiveness & complications of the TLE procedures in mentioned two groups of pts. Results: There are slight more woman in octo- and nanogenarians referred for TLE. In this groups there were more infective indications for TLE and less ICD systems as well. But in spite longer lead dwell time and longer pacing history TLE results were comparable to younger patients.

Leads dislodged into the pulmonary vascular bed in patients with cardiac implantable electronic devices.

IntroductionSpontaneous lead dislodgement into the pulmonary circulation is a rare complication of permanent pacing with unproven harmfulness and an indication of controversial class for transvenous lead extraction (TLE).AimTo assess TLE safety in patients with leads dislodged into the pulmonary artery.Material and methodsA retrospective analysis of a 9-year-old database of transvenous lead extraction procedures comprising 1767 TLEs was carried out, including a group of 19 (1.1%) patients with leads dislodged into the pulmonary artery (LDPA).ResultsUnder univariate analysis the factors that increased the likelihood of the presence of an electrode in the pulmonary artery were mean lead dwelling time (increase of risk by 9% per year), total number of leads in the heart before TLE (increase of risk by 66% for one lead) and the number of abandoned leads (increase of risk by 119%). The presence of LDPA was associated with frequent occurrence of intracardiac lead abrasion (increase by 316%) and isolated lead-related infective endocarditis (LRIE) (increase by 500%). There were no statistically significant differences in clinical (p = 0.3), procedural (p = 0.94) or radiological (p = 0.31) success rates in compared (LDPA and non-LDPA) groups. Long-term mortality after TLE was comparable in both groups.ConclusionsAs the effectiveness and safety of TLE in patients with LDPA are comparable to those in standard TLE procedures, in our opinion, such patients should be considered TLE candidates.

Abstract 10903: Extraction Outcomes in Patients With Congenital Heart Disease

Introduction: Patients with congenital heart disease (CHD) frequently require implantable cardiac devices. Device infection or malfunction may necessitate lead extraction. Extraction may be challenging due to long lead dwell times, anatomic abnormalities, and prior cardiac surgery. Little is known about extraction outcomes in the CHD population. Methods and Results: This retrospective study included 41 CHD patients and 82 age and gender matched controls that underwent lead extractions at two centers between 2001-2014. Only patients with leads older than 12 months were included. There were 79 leads in CHD patients and 150 in controls. Patients with CHD had a mean age of 39±17 years at extraction and on average their leads had been implanted for 81±84 months, this was not significantly different from the control group. Eighty eight percent of CHD patients had 1 or more cardiac surgeries as compared to only 22% of controls (p&lt;0.001). The number of abandoned leads was also significantly different with 16 abandoned leads in the CHD group and 3 in controls (p&lt;0.001). There was no statistically significant difference in extraction techniques between the groups. Complete extraction was achieved in 94% of patients in both groups. There were no CHD group complications. Control group complications included 3 SVC lacerations requiring sternotomy (one was fatal), and 1 ventricular perforations with tamponade requiring sternotomy. None of these patients had a history of cardiac surgery. The average age of leads in patients with a complication was 15.3 years which was older than the mean lead age seen in the CHD and control populations which was 6.75 and 4.6 years respectively. Conclusions: Lead extraction can be safely performed in patients with CHD. Despite anatomic abnormalities and previous cardiac surgery, the outcome of lead extraction in patients with CHD is comparable to controls. Prior cardiac surgery may lower the risk for extraction complications.

Management of malfunctioning and recalled pacemaker and defibrillator leads: results of the European Heart Rhythm Association survey.

The aim of this survey was to describe the different strategies regarding the management of malfunctioning and recalled pacemaker and defibrillator leads across Europe. A questionnaire has been designed to assess the current practice and physician's approach to the management of leads which are faulty, unnecessary, and/or recalled. Responses to the questionnaire were received from 34 hospitals-members of the European Heart Rhythm Association (EHRA) electrophysiology (EP) research network. The survey involved both very high and low volume implanting centres, with 85% of the responding centres performing lead extraction. The survey provides a panoramic view of operator's decision making in the field of malfunctioning, recalled, and redundant leads and outlines a common point of view on lead abandonment and factors influencing the decision about lead extraction. The main factors strongly influencing the decision making were patient's age (59%), the presence of the damaged leads (44%), and the lead dwelling time (44%). Regarding the lead abandonment, the main concern (61%) was the potential greater difficulty associated with lead extraction in the future. High volume extracting centres showed a greater propensity to removing the malfunctioning or recalled leads compared with low volume or non-extracting centres. This EP Wire survey gives a snapshot of the operators' approaches and options regarding redundant, malfunctioning, and recalled lead management and may form the basis for future prospective research on this topic.

AGE AND GEOGRAPHIC VARIATIONS OF PACEMAKER IMPLANTATION IN BC

utility in the assessment of the Biotronik Linox family of leads has not been studied. METHODS: We conducted a retrospective chart study at our center to assess the performance of LIA for lead system events (LSE) and lead failure in Linox leads. LIA-enabled Medtronic devices connected to an active Linox lead were included in the study. LIA is triggered in the presence of 2 of the following: abrupt change in pacing or shocking lead impedance, frequent short R-R intervals (<140ms) or 2 ICD-defined episodes of rapid non-sustained ventricular tachycardia (NSVT) (R-R<220ms). The alerts were adjudicated by two electrophysiologists and correlated with clinical data. RESULTS: Between 2008-2012, 364 Linox (S65, n1⁄498 and SD65, n1⁄4111) leads were implanted. Data from 209 patients with 509 patients-years of follow-up were available for LIA analysis. Information from 155 patients was not analyzed (absence of non LIA-enabled ICD and follow-up at another center). Mean age at implantation was 59 16 years (88% males). The mean lead dwell-time at the last follow-up visit was 2.6 1.2 years. Nineteen LIA triggers were noted in 18 different patients (1 patient had 2 Linox leads) during the study period (9.1%). The median dwelltime until LIA trigger was 31 months (range 5-44 months). One LIA event was false positive (electrocautery noise during surgery). All other alerts were true LSEs (18/209, 8.6%). Most common triggers were short V-V intervals (10/19[53%]) followed by NSVT in 9/19 (47%) patients. Abrupt changes of the ICD-lead impedance occurred in 5 cases (26%). Abnormal sensing integrity counters (SIC) were significantly more often triggered in patients with positive LIA (78%vs24%; p<0.001). Inappropriate ICDshocks were strongly associated with a positive LIA (28% vs6%; p1⁄40.009). Fourteen patients with Linox leads underwent 15 lead extractions based on LIA data (1 patient had 2 extractions). Most affected leads had significant macroscopic abnormality at explant. The values for sensitivity, specificity and positive predictive value for lead failure in the presence of a LIA trigger were 100%, 99.5% and 94.7% respectively. CONCLUSION: The Lead Integrity Alert algorithm is useful for the assessment of Linox lead performance. A positive LIA trigger in Biotronik Linox leads is highly predictive of lead failure.

Endocardial silicone lead wear: description of tribological phenomena on the basis of microscopic examination of removed leads. Preliminary report.

The passage of a lead in tissues and in the cardiovascular system depends on the implantation technique. The structure of the leads, which is a combination of two or more materials, triggers their wear. Breakage of the external pacemaker (PM) lead insulation causes unsealing of the lead and exposure of its internal spaces, which can be the anchor of lead-dependent infective endocarditis (LDIE). In the case of implantable cardioverter-defibrillator (ICD) leads, damage to external insulation isthe cause of externalisation of the cable. To describe endocardial lead abrasion as a tribological phenomenon resulting from rubbing the leads against each other in the mechanism of polymer on polymer friction, and other mechanisms associated with lead structure i.e. polymer on metal friction. Twenty-two leads were extracted from ten patients (three women) aged 66.5 ± 13.4 years. In all cases, the reason for lead removal was infection — in 80% LDIE. The PM (one ICD) two- and three-lead systems, all with silicone insulation, were aged 3–25, mean 8.3 years. The destroyed polymer insulation was examined by optical and scanning electron microscopy. The site of damage was defined as the length of the lead from its distal end. This lead segment motion was analysed on chest scopy performed prior to the removal procedure. In this way, three sites of lead damage were distinguished: intracardiac, intravenous, and intrapocket. Tribological wear was observed on the polymer-metal interface and between the leads. The following characteristics were recorded: the type of PM or ICD system in which the extracted leads worked, the lead dwell time,and the lead model. Scanning electron examinations showed that in all cases lead insulation had undergone tribological failure. In all samples, the image of fatigue wear was recorded. In all examined places, we found evidence that adhesive wear was present with the transfer of material to the edges of friction zones and/or to friction partners. In 80% of the patients with LDIE, a total breakage of insulation and abrasive wear was observed, especially when a lead cyclically bent and rubbed against another lead. Abrasive wear was the cause of lead unsealing at sites of strong lead bending, in the right atrium near the tricuspid valve. Acknowledging the tribological mechanism may connect the commonly known crush syndrome with lead abrasion in the cardiac implantable device pocket and in the heart cavity.

Lead dependent tricuspid dysfunction: Analysis of the mechanism and management in patients referred for transvenous lead extraction

Lead-dependent tricuspid dysfunction (LDTD) is one of important complications in patients with cardiac implantable electronic devices. However, this phenomenon is probably underestimated because of an improper interpretation of its clinical symptoms. The aim of this study was to identify LDTD mechanisms and management in patients referred for transvenous lead extraction (TLE) due to lead-dependent complications. Data of 940 patients undergoing TLE in a single center from 2009 to 2011 were assessed and 24 patients with LDTD were identifi ed. The general indications for TLE, pacing system types and lead dwell time in both study groups were comparatively analyzed. The radiological and clinical effi cacy of TLE procedure was also assessed in both groups with precision estimation of clinical status patients with LDTD (before and after TLE). Additionally, mechanisms, concomitant lead-dependent complications and degree (severity) of LDTD before and after the procedure were evaluated. Telephone follow-up of LDTD patients was performed at the mean time 1.5 years after TLE/replacement procedure. The main indications for TLE in both groups were similar (apart from isolated LDTD in 45.83% patients from group I). Patients with LDTD had more complex pacing systems with more leads (2.04 in the LDTD group vs. 1.69 in the control group; p = 0.04). There were more unnecessary loops of lead in LDTD patients than in the control group (41.7% vs. 5.24%; p = 0.001). There were no signifi cant differences in average time from implantation to extraction and the number of preceding procedures. Signifi cant tricuspid regurgitation (TR-grade III-IV) was found in 96% of LDTD patients, whereas stenosis with regurgitation in 4%. The 10% frequency of severe TR (not lead dependent) in the control group patients was observed. The main mechanism of LDTD was abnormal leafl et coaptation caused by: loop of the lead (42%), septal leafl et pulled toward the interventricular septum (37%) or too intensive lead impingement of the leafl ets (21%). LDTD patients were treated with TLE and reimplantation of the lead to the right ventricle (87.5%) or to the cardiac vein (4.2%), or surgery procedure with epicardial lead placement following ineffective TLE (8.3%). The radiological and clinical effi cacy of TLE procedure was very high and comparable between the groups I and II (91.7% vs. 94.2%; p = 0.6 and 100% vs. 98.4%; p = 0.46, respectively). Repeated echocardiography showed reduced severity of tricuspid valve dysfunction in 62.5% of LDTD patients. The follow- -up interview confi rmed clinical improvement in 75% of patients (further improvement after cardiosurgery in 2 patients was observed). LDTD is a diagnostic and therapeutic challenge. The main reason for LDTD was abnormal leafl et coaptation caused by lead loop presence, or propping, or impingement the leafl ets by the lead. Probably, TLE with lead reimplantation is a safe and effective option in LDTD management. An alternative option is TLE with omitted tricuspid valve reimplantation. Cardiac surgery with epicardial lead placement should be reserved for patients with ineffective previous procedures.