Transvenous lead extraction: Efficacy and safety of the procedure in female patients.

Background: Existing data on the impact of sex differences on transvenous lead extraction (TLE) outcomes in cardiac device patients are limited. Objective: The purpose of this study was to evaluate the safety and efficacy of mechanical TLE in female patients. Methods: A retrospective evaluation was performed on 3051 TLE patients (group 1: female; group 2: male) from a single tertiary referral center. All individuals received treatment using single sheath mechanical dilation and various venous approaches as required. Results: Our analysis included 3051 patients (group 1: 750; group 2: 2301), with a total of 5515 leads handled with removal. Female patients were younger, had a higher left ventricular ejection fraction, and lower prevalences of coronary artery disease and diabetes mellitus. Infection was more common in male patients, whereas lead malfunction or abandonment were more frequent in female patients. Radiologic success was lower in female patients (95.8% vs 97.5%; P = .003), but there was no significant difference in clinical success between groups (97.2% vs 97.5%; P = .872). However, major complications (1.33% vs 0.60%; P <.001) and procedural mortality (0.4% vs 0.1%; P <.001) were higher in females compared to male patients. After multivariate analysis, female sex emerged as the only predictor of major complications, including deaths (odds ratio 3.96; 95% confidence interval 1.39-11.24). Conclusion: TLE using unpowered simple mechanical sheaths in female patients is safe and effective, but is associated with lower radiologic success and higher complication rates and mortality than in males. This finding underscores the importance of recognizing sex differences in TLE outcomes.

Feasibility and Accuracy of Noninvasive Continuous Arterial Pressure Monitoring during Transcatheter Atrial Fibrillation Ablation.

INTRODUCTION: Transcatheter atrial fibrillation (AF) ablation is still carried out with continuous invasive radial arterial blood pressure (IBP) monitoring in many centers. Continuous noninvasive blood pressure (CNBP) measurement using the volume-clamp method is a noninvasive alternative method used in ICU. No data on CNBP reliability are available in the electrophysiology lab during AF ablation, where rhythm variations are common. BACKGROUND: The objective of the present study was to compare continuous noninvasive arterial pressure measured with the ClearSight device (Edwards Lifesciences, Irvine, CA, USA) with invasive radial artery pressure used as the reference method during AF ablation. METHODS: We prospectively enrolled 55 consecutive patients (age 62 ± 11 years, 80% male) undergoing transcatheter AF ablation (62% paroxysmal, 38% persistent) at our center. Standard of care IBP monitoring via a radial cannula and a contralateral noninvasive finger volume-clamp CNBP measurement device were positioned simultaneously in all patients for the entire procedure. Bland-Altman analysis was used to analyze the agreement between the two techniques. RESULTS: A total of 1219 paired measurements for systolic, diastolic, and mean arterial pressure were obtained in 55 subjects, with a mean (SD) of 22 (9) measurements per patient. The mean bias (SD) was -12.97 (13.89) mmHg for systolic pressure (level of agreement -14.24-40.20; correlation coefficient 0.84), -1.85 (8.52) mmHg for diastolic pressure (level of agreement -18.54-14.84; correlation coefficient 0.77) and 2.31 (8.75) mmHg for mean pressure (level of agreement -14.84-19.46; correlation coefficient 0.85). CONCLUSION: In patients undergoing AF ablation, CNBP monitoring with the ClearSight device showed acceptable agreement with IBP monitoring. Larger studies are needed to confirm the potential clinical implications of continuous noninvasive BP monitoring during AF ablation.

His-bundle pacing to treat an unusual case of chest pain after pacemaker implant.

A 63-year-old man with hypertension and 3-vessel coronary artery disease previously treated with coronary artery bypass graft was admitted to our emergency room complaining of chest pain. He had undergone pacemaker implant 5 months before due to paroxysmal advanced atrioventricular block. Electrocardiography and troponin testing were unremarkable. Echocardiography and chest X-ray ruled out lead displacement and perforation. Interrogation showed normal parameters [right atrium: impedance 550 Ohm bipolar, sensing 2.4 mV bipolar; threshold 0.50 V/0.4 ms bipolar; right ventricle (RV): impedance 580 Ohm bipolar, sensing > 25 mV bipolar; threshold 1.5 V/0.4 ms bipolar and 0.4 V/0.4 ms unipolar]. Pain was evoked only during RV pacing. An electrophysiology study demonstrated painful RV pacing from multiple sites. We hypothesized that pain was associated with pacing-induced dyssynchrony. His-bundle pacing (HBP) was considered as a solution. We achieved HBP with a bipolar fixed-screw catheter connected to a cardiac resynchronization therapy pacemaker generator. During HBP above threshold (4.00 V/1.00 ms) the patient did not complain of any pain. He was discharged 3 days later pain-free with His-bundle lead amplitude set at 5.00 V/1.00 ms. After 6 months the patient was asymptomatic, with the device showing normal functioning. This is the first clinical experience of painful RV pacing treated with HBP. .

Comparison between leadless and transvenous single-chamber pacemaker therapy in a referral centre for lead extraction.

PURPOSE: The aim of the study was to compare the long-term clinical and electrical performance of Micra leadless pacemaker with transvenous single-chamber pacemaker (TV-VVI PM) in a high-volume centre for transvenous lead extraction (TLE). METHODS: One-hundred patients (group 1) undergoing Micra implant were matched with 100 patients undergoing TV-VVI PM implant (group 2) by age, sex, left ventricular systolic ejection fraction and previous TLE. RESULTS: The implant procedure was successful in all patients. In group 1, the procedure duration was lower than in group 2 (43.86 ± 22.38 vs 58.38 ± 17.85 min, p < 0.001), while the fluoroscopy time was longer (12.25 ± 6.84 vs 5.32 ± 4.42 min, p < 0.001). There was no difference about the rate of septal implant at the right ventricle (76% vs 86%, p = 0.10). Patients were followed-up for a median of 12 months. No acute and chronic procedure-related complication was observed in group 1, while we reported acute complications in seven patients (7%, p = 0.02) and long-term complications in three patients (3%, p = 0.24), needing for a system revision in 6 cases (6%, p = 0.038), in group 2. One systemic infection occurred in TV-VVI PM group. Electrical measurements were stable during follow-up in both groups, with a longer estimated battery life in group 1 (mean delivered energy at threshold at discharge: 0.14 ± 0.21 vs 0.26 ± 0.22 µJ, p < 0.001). CONCLUSION: Micra pacemaker implant is a safe and effective procedure, with a lower rate of acute complications and system revisions compared with TV-VVI PM, even in a real-life setting including patients who underwent TLE.

Role of pre-procedural CT imaging on catheter ablation in patients with atrial fibrillation: procedural outcomes and radiological exposure.

BACKGROUND: Cardiac computed tomography (CT) is commonly used to study left atrial (LA) and pulmonary veins (PVs) anatomy before atrial fibrillation (AF) ablation. The aim of the study was to determine the impact of pre-procedural cardiac CT with 3D reconstruction on procedural outcomes and radiological exposure in patients who underwent radiofrequency catheter ablation (RFA) of AF. METHODS: In this registry, 493 consecutive patients (age 62 ± 8 years, 70% male) with paroxysmal (316) or persistent (177) AF who underwent first procedure of RFA were included. A pre-procedural CT scan was obtained in 324 patients (CT group). Antral pulmonary vein isolation was performed in all patients using an open-irrigation-tip catheter with a 3D electroanatomical navigation system. Procedural outcome, including radiological exposure, and clinical outcomes were compared among patients who underwent RFA with (CT group) and without (no CT group) pre-procedural cardiac CT. RESULTS: Acute PV isolation was obtained in all patients, with a comparable overall complication rate between CT and no CT group (4.3% vs 3%, p = 0.7). No differences were observed about mean duration of the procedure (231 ± 60 vs 233 ± 58 min, p = 0.7) and fluoroscopy time (13 ± 10 vs 13 ± 8 min, p = 0.6) among groups. Cumulative radiation dose resulted significantly higher in the CT group compared with no CT group (8.9 ± 24 vs 4.8 ± 15 mSv, P = 0.02). At 1 year, freedom from AF/atrial tachycardia were comparable among groups (CT group, 227/324 (70%), vs no CT group,119/169 (70%), p = ns). CONCLUSIONS: Pre-procedural CT does not improve safety and efficacy of AF ablation, increasing significantly the cumulative radiological exposure.

Safety and efficacy of transvenous mechanical lead extraction in patients with abandoned leads.

AIMS: Optimal management of redundant or malfunctioning leads is controversial. We aimed to assess safety and efficacy of mechanical transvenous lead extraction (TLE) in patients with abandoned leads. METHODS AND RESULTS: Consecutive TLE procedures performed in our centre from January 2009 to December 2017 were considered. We evaluated the safety and efficacy of mechanical TLE in patients with abandoned (Group 1) compared to non-abandoned (Group 2) leads. We analysed 1210 consecutive patients that required transvenous removal of 2343 leads. Group 1 accounted for 250 patients (21%) with a total of 617 abandoned leads (26%). Group 2 comprised 960 patients (79%) with 1726 leads (74%). The total number of leads (3.0 vs. 2.0), dwelling time of the oldest lead (108.00 months vs. 60.00 months) and infectious indications for TLE were higher in Group 1. Clinical success was achieved in 1168 patients (96.5%) with a lower rate in Group 1 (90.4% vs. 98.1%; P < 0.001). Major complications occurred in only 9 patients (0.7%), without significant differences among the two groups. The presence of one or more abandoned leads [odds ratio (OR) 3.47; 95% confidence interval (CI) 1.07-11.19; P = 0.037] and dwelling time of the oldest lead (OR 1.01 for a month; 95% CI 1.01-1.02; P < 0.001) were associated with a higher risk of clinical failure. CONCLUSION: Transvenous mechanical lead extraction is a safe procedure also in high-risk settings, as patients with abandoned leads. Success rate resulted a bit lower, especially in the presence of abandoned leads with long implantation time.

Predictors of zero X ray procedures in supraventricular arrhythmias ablation.

To evaluate predictors of zero-X ray procedures for supraventricular arrhythmias (SVT) using minimally fluoroscopic approach (MFA). Patients referred for RF catheter ablation of SVT were admitted for a MFA with an electro-anatomical navigation system or a conventional fluoroscopic approach (ConvA). Exclusion criterion was the need to perform a transseptal puncture. 206 patients (98 men, age 53 ± 19 years) underwent an EP study, 93 (45%) with an MFA and 113 (55%) with a ConvA. Fifty-five had no inducible arrhythmias (EPS). Fifty-four had AV nodal reentrant tachycardia (AVNRT), 49 patients had typical atrial flutter (AFL), 37 had AV reciprocating tachycardia (AVRT/WPW), 11 had focal atrial tachycardia (AT), and underwent a RF ablation. X-ray was not used at all in 51/93 (58%) procedures (zero X ray). MFA was associated with a significant reduction in total fluoroscopy time (5.5 ± 10 vs 13 ± 18 min, P = 0.01) and operator radiation dose (0.8 ± 2.5 vs 3 ± 8.2 mSV, P < 0.05). The greatest absolute dose reduction was observed in AVNRT (0.1 ± 0.3 vs 5.1 ± 10 mSV, P = 0.01, 98% relative dose reduction) and in AFL (1.3 ± 3.6 vs 11 ± 16 mSV, P = 0.003, 88% relative dose reduction) groups. Both AVNRT or AFL resulted the only statistically significant predictors of zero x ray at multivariate analysis (OR 4.5, 95% CI 1.5-13 and OR 5, 95% CI 1.7-15, P < 0.001, respectively). Success and complication rate was comparable between groups (P = NS). Using MFA for SVT ablation, radiological exposure is significantly reduced. Type of arrhythmia is the strongest predictor of zero X ray procedure.

Micra pacemaker implant after cardiac implantable electronic device extraction: feasibility and long-term outcomes.

AIMS: We aimed at investigating the feasibility and outcome of Micra implant in patients who have previously undergone transvenous lead extraction (TLE), in comparison to naïve patients implanted with the same device. METHODS AND RESULTS: Eighty-three patients (65 males, 78.31%; 77.27 ± 9.96 years) underwent Micra implant at our centre. The entire cohort was divided between 'post-extraction' (Group 1) and naïve patients (Group 2). In 23 of 83 patients (20 males, 86.96%; 73.83 ± 10.29 years), Micra was implanted after TLE. Indication to TLE was an infection in 15 patients (65.21%), leads malfunction in four (17.39%), superior vena cava syndrome in three (13.05%), and severe tricuspid regurgitation in one case (4.35%). The implant procedure was successful in all patients and no device-related events occurred at follow-up (median: 18 months; interquartile range: 1-24). No differences were observed between groups in fluoroscopy time (13.88 ± 10.98 min vs. 13.15 ± 6.64 min, P = 0.45), single device delivery (Group 1 vs. Group 2: 69.56% vs. 55%, P = 0.22), electrical performance at implant and at 12-month follow-up (Group 1 vs. Group 2: pacing threshold 0.48 ± 0.05 V/0.24 ms vs. 0.56 ± 0.25 V/0.24 ms, P = 0.70; impedance 640 ± 148.83 Ohm vs. 583.43 ± 99.7 Ohm, P = 0.27; and R wave amplitude 10.33 ± 2.88 mV vs. 12.62 ± 5.31 mV, P = 0.40). A non-apical site of implant was achievable in the majority of cases (72.3%) without differences among groups (78.26% vs. 70%; P = 0.42). CONCLUSION: Micra implant is an effective and safe procedure in patients still requiring a ventricular pacing after TLE, with similar electrical performance and outcome compared with naïve patients at long-term follow-up.

Feasibility and long-term effectiveness of a non-apical Micra pacemaker implantation in a referral centre for lead extraction.

AIMS: To demonstrate the feasibility and long-term performances of a non-apical Micra pacemaker implantation. METHODS AND RESULTS: Fifty-two consecutive patients underwent Micra implantation, targeting a non-apical site of delivery when feasible. Each patient received a regular follow-up (mean 13 ± 9 months). The first 17 patients were also enrolled in the Micra transcatheter pacing system trial (Group 1); the remaining ones presented broader indications and included post-extraction subjects (Group 2). In 19 of 52 patients (Group 1: 6%, Group 2: 51%; P = 0.002) Micra was implanted because of high-risk characteristics that discouraged the implantation of a traditional pacemaker. In 31 of 52 patients (60%) Micra was implanted in a non-apical location, with a lower rate of single delivery compared with apical sites (48% vs. 81%, P = 0.035), but without any impact on electrical performance. Pacing threshold remained optimal in the majority of patients (94%), regardless of the site of implantation (apical vs. non-apical location: 0.50 vs. 0.52 V/0.24 ms; P = 0.856) and group membership, with only 6% of the subjects showing elevated values (mean 1.92 ± 0.92 V/0.24 ms) at the last follow-up. No device-related adverse events were registered. CONCLUSION: Micra pacemaker implant is a safe and effective procedure even in a real life cohort of high-risk patients. A non-apical site of implantation is feasible in the majority of patients allowing stable electrical performance at long-term follow-up.

Utility of risk scores to predict adverse events in cardiac lead extraction.

INTRODUCTION: Increasing device implantations, patient comorbidities, and longer life expectancy contribute to an increased need for lead extraction. Even if transvenous lead extraction (TLE) is a highly successful procedure, some serious procedural complications are reported. In order to identify those patients who are at higher risk, risk stratification scores were proposed. Areas covered: The major obstacles to lead extractions are represented by the body's response to the foreign implanted material and by the following development of fibrotic reaction between the lead and the vascular system. Several clinical factors and device features are associated with major complications and worse outcomes. Although different multiparametric scores predicting the safety and the efficacy of TLE procedures were reported, none of these scores were prospective evaluated. Expert commentary: A correct risk stratification is needed in order to refer complex patients to centers with proven experience and avoid futile procedures. Furthermore, the identification of high-risk patients allows to perform the extraction procedure in the operating room instead of electrophysiology lab. Albeit some risk scores able to predict adverse event in cardiac lead extraction were described, there are still several limitations to their use and reproducibility.

Prevention of sudden cardiac death: from wearable to subcutaneous cardioverter defibrillator.

The implantable cardioverter defibrillator (ICD) is today an indisputable evidence-based treatment for cardiac sudden death both in primary and secondary prevention. However many clinical conditions that would represent an indication to ICD implantation, according to guidelines, may be potentially reversible or may be accompanied by temporary contraindications to the implant. Moreover transvenous cardioverter defibrillator implantation still carries a not negligible risk of complications both acutely and at follow-up. The Wearable Cardioverter Defibrillator and the Subcutaneous Defibrillator are two recently developed technologies that can potentially overcome the aforementioned limitations of traditional transvenous ICDs. This review will discuss the main aspects of these 2 technologies, the data coming from clinical experiences and future perspectives.

Overcoming the current issues surrounding device leads: reducing the complications during extraction.

INTRODUCTION: The implantation rate of cardiac implantable electronic devices has consistently increased in the last 20 years, as have the related complication rates. The most relevant issue is the removal of pacing and implantable cardioverter defibrillator (ICD) leads, which a few months after implantation tend to develop intravascular fibrosis, often making extraction a challenging and risky procedure. Areas covered: The transvenous lead extraction (TLE) scenario is constantly evolving. TLE is a key procedure in lead management strategies. Many efforts have been made to develop new TLE approaches and techniques allowing a safe and effective procedure for patients. The increasing rate of cardiac implantable electronic device (CIED) implantations and of CIED related complications highlight the importance of TLE. Lead related- and patient-related factors may change the future of extractions. We review the current status of TLE, focusing on the strategies available to perform the optimal procedure in the right patient and reducing procedure related complications. Expert commentary: Understanding the importance of an accurate TLE risk stratification is mandatory to optimize the procedural risk-to-benefits ratio. The use of adequate tools, techniques and approaches, and appropriate training are cornerstones for the achievement of safer procedures.

Where is the future of cardiac lead extraction heading?

INTRODUCTION: Transvenous lead extraction (TLE) is the gold standard for lead removal. The increasing rate of cardiac implantable electronic device (CIED) implantations and of CIED related complications highlight the importance of transvenous lead extraction . AREAS COVERED: The TLE scenario is constantly changing. Optimizing lead related technology and improving TLE practice across the world are the cornerstones to improving safety and efficacy. We review the state of the art in TLE, focusing on potential future implications and improvements in terms of skills and technologies. Expert commentary: The increased number of extractions will increase the necessity of safe and effective TLE. New technologies, techniques and appropriate training is warranted across the world.

Subcutaneous implantable cardiac defibrillators: indications and limitations.

The implantable cardioverter defibrillator is today an indisputable evidence-based treatment for cardiac sudden death both in primary and secondary prevention. However, trans-venous cardioverter defibrillator implantation still carries a not negligible risk of complications both acutely and during follow-up. Trans-venous endocardial lead is the weak link of implantable cardioverter defibrillator (ICD) technology being the source of most mechanical complications on vessels and heart structures and exposed to infection, malfunction and recalls. A totally subcutaneous defibrillation lead has recently been introduced in clinical practice. With the subcutaneous pulse generator forms a defibrillation system that leaves the vessels and the heart completely "untouched." Subcutaneous ICD has proven to be safe and effective in many clinical trials. Patients without pacing indications and at higher risk of complications from trans-venous lead implantation represent the perfect candidates to S-ICD technology. However, with technical improvement, it is reasonable to expect a further expansion of indications.

Transvenous extraction profile of Riata leads: procedural outcomes and technical complexity of mechanical removal.

BACKGROUND: Riata (RT) and Sprint Fidelis (SF) leads were recalled by the United States Food and Drug Administration because of an increased rate of failure mainly due to conductor fracture or insulation abrasion. According to lead design and type of failure, extraction complexity may be different, potentially affecting procedural outcomes and indications. OBJECTIVE: The purpose of this study was to assess the extraction profile of RT leads with and without cable externalization in comparison to SF leads. METHODS: From January 1997 to April 2014, all consecutive RT and SF leads extracted transvenously were analyzed. Among 661 consecutive patients with 705 ventricular implantable cardioverter-defibrillator (ICD) leads extracted, 194 patients with 134 RT leads (RT group) and 61 SF leads (SF group) were identified. Removal indications often were infective (64%), and extracted leads had a prevalence of dual-coil design (89%). Baseline patients and lead characteristics were comparable between groups. RESULTS: Success rate was high in both groups (97.8% RT vs 100% SF) without major complications. Mechanical dilation was comparable between groups, but RT leads often required larger sheaths (11.7 ± 1.4 vs 11.3 ± 1.4), a more frequent crossover to the internal transjugular approach (14% vs 3%), and a longer procedural time (23 ± 33 minutes vs 12 ± 16 minutes). Implantation time (odds ratio 4.84, 95% confidence interval 1.05-22.2, P = .042) and RT leads (odds ratio 1.04, 95% confidence interval 1.02-1.06, P <.001) were independent predictors of the internal transjugular approach. CONCLUSION: Extraction of RT leads is feasible and effective. However, extraction of RT leads is more complex than that of SF leads. Lack of coil backfilling and cable externalization in RT group may account for these differences.

A Questionable Indication For ICD Extraction After Successful VT Ablation.

Sustained ventricular tachyarrhythmias represent a kind of complication shared by a number of clinical presentations of heart disease, sometimes leading to sudden cardiac death. Many efforts have been made in the fight against such a complication, mainly being represented by the implantable cardioverter defibrillator (ICD). In recent years, catheter ablation has grown as a means to effectively treat patients with sustained ventricular arrhythmias, in the contest of different cardiac substrates. Since carrying an ICD is associated with a potential risk deriving from its possible infective or malfunctioning complications, and given the current effectiveness of lead extraction procedures, it has been thought not to be unreasonable to ask ourselves about how to deal with ICD patients who have been successfully treated by means of ablation of their ventricular arrhythmias. To date, no control data have been published on transvenous lead extraction in the setting of VT ablation. In this paper we will review the current evidence about ICD therapy, catheter ablation of ventricular arrhythmias and lead extraction, trying to outline some considerations about how to face this new clinical issue.

Major predictors of fibrous adherences in transvenous implantable cardioverter-defibrillator lead extraction.

BACKGROUND: Percutaneous removal of implantable cardioverter-defibrillator (ICD) leads is a difficult procedure because of the consequence of massive fibrous tissue growth along the lead. OBJECTIVE: The purpose of this study was to describe the occurrence and location of fibrous adherences in ICD lead extraction and to identify potential predictors among patient and lead characteristics. METHODS: We studied 637 consecutive patients who underwent transvenous extraction of 678 ICD leads from 1997 to 2013. RESULTS: Procedural success rate was 99%, without major complications. Areas of adherence were found in the subclavian vein (78%), innominate vein (65%), superior vena cava (66%), and heart (73%). Dwell-time, passive fixation, and dual-coil lead design were independently associated with adherences. Dual-coil lead design was associated with adherences in the innominate vein and superior vena cava, whereas coil treatment (eg, expandable polytetrafluoroethylene-coated or medical adhesive back-filled strategies) prevented adherences. Passive fixation mechanism was associated with adherences in the heart. CONCLUSION: ICD leads, after long dwell-time, are affected by fibrous adherences uniformly distributed along the lead course. Lead features represent major predictors of the phenomenon. Careful lead selection is recommended at the time of implantation to prevent adherences. In addition, lead-related risk stratification is mandatory before a transvenous extraction procedure.

Safety and efficacy of internal transjugular approach for transvenous extraction of implantable cardioverter defibrillator leads.

AIMS: We report our 15 years experience of a mechanical single-sheath technique with a multiple venous entry-site approach. We evaluated the effectiveness and safety of this technique in implantable defibrillator (ICD) lead extraction and investigated the potential association between clinical and lead-related factors and procedural complexity. METHODS AND RESULTS: The proposed technique consists of an initial attempt at manual traction, followed by mechanical dilatation performed through the venous entry-site and, if necessary, by crossover to the internal transjugular approach. The study cohort comprised 545 consecutive patients referred to our institution for transvenous lead extraction from January 1997 to December 2012. Initial manual traction resulted in the effective removal of 6% of leads. Mechanical dilatation increased the success rate to 89% when performed through the venous entry-site, and to 99% when subsequently attempted via the internal jugular vein. No major complications were associated with lead extraction. Dwell-time, a passive fixation mechanism and dual-coil lead design were independently associated with the need for mechanical dilatation. However, dwell-time was the only variable associated with crossover to the internal transjugular approach. Specifically, a dwell-time of 20 months best predicted the need for venous entry-site mechanical dilatation, while a value of 55 months predicted crossover to the internal transjugular approach. CONCLUSION: Mechanical transvenous extraction of ICD leads is a complex but safe and effective procedure. A longer lead dwell-time is associated with the need for mechanical dilatation and for crossover to the internal transjugular approach; this should be considered when planning the removal procedure. Moreover, passive lead fixation and dual-coil lead design predict a more challenging extraction procedure.