Performance and outcomes of transvenous rotational lead extraction: Results from a prospective, monitored, international clinical study.

BACKGROUND: Transvenous lead extraction (TLE) plays a critical role in managing patients with cardiovascular implantable electronic devices. Mechanical TLE tools, including rotational sheaths, are used to overcome fibrosis and calcification surrounding leads. Prospective clinical data are limited regarding the safety and effectiveness of use of mechanical TLE devices, especially rotational tools. OBJECTIVE: To prospectively investigate the safety and effectiveness of mechanical TLE in real-world usage. METHODS: Patients were enrolled at 10 sites in the United States and Europe to evaluate the use of mechanical TLE devices. Clinical success, complete procedural success, and complications were evaluated through follow-up (median, 29 days). Patient data were source verified and complications were adjudicated by an independent clinical events committee (CEC). RESULTS: Between October 2018 and January 2020, mechanical TLE tools, including rotational sheaths, were used to extract 460 leads with a median indwell time of 7.4 years from 230 patients (mean age 64.3 ± 14.4 years). Noninfectious indications for TLE were more common than infectious indications (61.5% vs 38.5%, respectively). The extracted leads included 305 pacemaker leads (66.3%) and 155 implantable cardioverter-defibrillator leads (33.7%), including 85 leads with passive fixation (18.5%). A bidirectional rotational sheath was needed for 368 leads (88.0%). Clinical success was obtained in 98.7% of procedures; complete procedural success was achieved for 96.3% of leads. CEC-adjudicated device-related major complications occurred in 6 of 230 (2.6%) procedures. No isolated superior vena cava injury or procedural death occurred. CONCLUSION: This prospective clinical study demonstrates that use of mechanical TLE tools, especially bidirectional rotational sheaths, are effective and safe.

Efficacy and safety of regenerated cellulose topical gauze haemostats in managing secondary haemostasis: a randomised control trial.

OBJECTIVE: To compare the efficacy and safety of HemoStyp (United Health Products, US), a neutralised oxidised regenerated cellulose (NORC) and Surgicel (Johnson & Johnson, US), an oxidised regenerated cellulose (ORC), in the management of bleeding of surgical wounds during abdominal, thoracic and vascular surgeries. METHOD: This study was a prospective, non-inferiority, multicentre, randomised, open-label trial. Surgical procedures were performed according to expected standard of care and in compliance with all relevant laws and institutional guidelines. Patients who developed Lewis Bleeding Scale grade 1 and grade 2 bleeds not controlled through conventional techniques were randomised to either the NORC or ORC treatment arms. Bleeding was measured every 30 seconds after treatment, ending at five minutes after haemostasis was achieved or at 10 minutes if haemostasis was not achieved. RESULTS: A total of 236 patients were included in the study. There was a total of seven adverse events in the study, none of which had causality related to either the NORC or ORC. For all surgical procedures, haemostasis was achieved more quickly with the NORC than the ORC (p<0.0001). In addition, haemostasis for all patients was achieved in under two minutes for the NORC compared with 81% of patients in the ORC groups. For Lewis Bleeding Scale grade 1 bleeds, the median time to control bleeding was 24 seconds in the NORC group and 51 seconds for the ORC group. For grade 2 bleeds, time to control bleeding was 76 seconds and 116 seconds, respectively. CONCLUSION: For patients in this study, haemostasis was achieved more quickly in the NORC treatment group compared with the ORC group, in patients with Lewis grade 1 or 2 bleeds caused by surgical wounds generated during abdominal, thoracic and vascular surgeries.

Transcatheter aspiration of large pacemaker and implantable cardioverter-defibrillator lead vegetations facilitating safe transvenous lead extraction.

AIMS: Treatment of patients with systemic cardiac implantable electronic device (CIED) infection with large lead vegetations is challenging and associated with relevant morbidity and mortality. To avoid complications from open surgical extraction, a novel approach with percutaneous aspiration of large vegetations prior to transvenous lead extraction was instituted. The results of this treatment concept were retrospectively analysed in this multicentre study. METHODS AND RESULTS: One hundred and one patients [mean age 68.2 ± 13.1 (30-92) years] were treated in four centres for endovascular CIED infection with large lead vegetations. Mean lead vegetation size was 30.7 ± 13.5 mm. Two hundred and forty-seven leads were targeted for extraction (170 pacemaker leads, 77 implantable cardioverter-defibrillator leads). Mean lead implant duration was 81.7 (1-254) months. The transcatheter aspiration system with a specialized long venous drainage cannula and a funnel-shaped tip was based on a veno-venous extracorporeal circuit with an in-line filter. The aspiration of vegetations showed complete procedural success in 94.0% (n = 95), partial success in 5.0% (n = 5). Three major complications (3.0%) were encountered. Complete procedural success (per lead) of the subsequently performed transvenous lead extraction procedure was 99.2% (n = 245). Thirty-day mortality was 3.0% (n = 3). Five patients (5.0%) died in the further course on Days 51, 54, 68, 134, and 182 post-procedure (septic complications: n = 4; heart failure: n = 1). CONCLUSION: The percutaneous aspiration procedure is highly effective and is associated with a low complication profile. The aspiration of vegetations immediately prior and during the lead extraction procedure may avoid septic embolization into the pulmonary circulation. This may potentially lead to a long-term survival benefit.

Regional Thoracic Surgery Quality Collaboration Formation: Providence Thoracic Surgery Initiative.

BACKGROUND: Surgery quality initiatives improve clinical outcomes in cardiac and general surgery. No mature thoracic surgery (TS) regional effort has been described. METHODS: An intramural grant funded the Thoracic Surgery Initiative (TSI). Professional organization, site-specific administrative and clinical databases were used to identify surgeons performing TS across a large Western health system. Participants were recruited through stakeholder surveys, personal contact, and meetings. Differences in practices and outcomes were identified. Fourteen centers performing TS in 5 states formed the TSI with a mission to define, implement, and monitor TS quality. RESULTS: A TS data system based on The Society of Thoracic Surgeons General Thoracic Surgery Database was implemented. Clinical data from 2015 and 2016 revealed significant differences in outcomes. Clinical data allow quality implementation, including identification and propagation of internal best practices and monitoring. TS practice standardization was agreed to using predefined TS best practice components that were incorporated into standardized TS care documents. Standardized care document completion by providers was intended to provoke desired TS care. The standardized care documents reside on the system-wide electronic health record. Literature and substantial surgeon experience were used to develop standardized TS care pathways for important or common clinical scenarios (pneumonectomy, primary spontaneous pneumothorax, etc). The TSI internet site serves as a harbor for standardization products. CONCLUSIONS: The TSI is evolving. Surgeon engagement remains high. The TSI enabled surgeons to lead, set the agenda, and remain in control of our destiny. Indeed, health care cannot appropriately evolve without such physician vision, engagement, and leadership.

Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator.

BACKGROUND: The presence of a cardiovascular implantable electronic device has long been a contraindication for the performance of magnetic resonance imaging (MRI). We established a prospective registry to determine the risks associated with MRI at a magnetic field strength of 1.5 tesla for patients who had a pacemaker or implantable cardioverter-defibrillator (ICD) that was "non-MRI-conditional" (i.e., not approved by the Food and Drug Administration for MRI scanning). METHODS: Patients in the registry were referred for clinically indicated nonthoracic MRI at a field strength of 1.5 tesla. Devices were interrogated before and after MRI with the use of a standardized protocol and were appropriately reprogrammed before the scanning. The primary end points were death, generator or lead failure, induced arrhythmia, loss of capture, or electrical reset during the scanning. The secondary end points were changes in device settings. RESULTS: MRI was performed in 1000 cases in which patients had a pacemaker and in 500 cases in which patients had an ICD. No deaths, lead failures, losses of capture, or ventricular arrhythmias occurred during MRI. One ICD generator could not be interrogated after MRI and required immediate replacement; the device had not been appropriately programmed per protocol before the MRI. We observed six cases of self-terminating atrial fibrillation or flutter and six cases of partial electrical reset. Changes in lead impedance, pacing threshold, battery voltage, and P-wave and R-wave amplitude exceeded prespecified thresholds in a small number of cases. Repeat MRI was not associated with an increase in adverse events. CONCLUSIONS: In this study, device or lead failure did not occur in any patient with a non-MRI-conditional pacemaker or ICD who underwent clinically indicated nonthoracic MRI at 1.5 tesla, was appropriately screened, and had the device reprogrammed in accordance with the prespecified protocol. (Funded by St. Jude Medical and others; MagnaSafe ClinicalTrials.gov number, NCT00907361 .).

Defibrillation thresholds with right pectoral implantable cardioverter defibrillators and impact of waveform tuning (the Tilt and Tune trial).

AIMS: Assess defibrillation thresholds (DFTs) with right active pectoral implantable cardioverter defibrillator (RICDs). Defibrillation thresholds in patients receiving RICDs are regarded as 'high' and potentially improved by waveform optimization (tuning). However, this has not been systematically tested. METHODS AND RESULTS: Patients receiving RICDs [Single chamber (VVI) = 16, DDD = 32, cardiac resynchronization therapy (CRT) = 43] were randomized to either 50/50% fixed tilt (FT) or tuned waveform (3.5 ms time constant based). Defibrillation threshold was tested with a binary search protocol in single coil anodal configuration. Then RICDs were compared with left-sided placements. Baseline patient characteristics in FT (n = 54) and tuned (n = 37) were similar (65 ± 14 years, 71% male, Left ventricular ejection fraction 31 ± 13%; and proportions VVI/DDD/Cardiac resynchronization therapy defibrillator). Tuning reduced Phase 1 by 15% and Phase 2 by 45%. For FT vs. tuned: high voltage impedance was 61.9 ± 13.2 vs. 64.5 ± 12.7 Ω (P = 0.33) and mean DFT 14.2 ± 8.8 vs. 14.9 ± 9.2 J (P = 0.8). When high voltage impedance was >62 Ω (mean 73.6 ± 8.6 Ω), DFT was identical [FT 13.0 ± 7.9 J vs. tuned 12.0 ± 5.9 J (P= 0.7)]. Defibrillation thresholds exceeded 20 J (600 V) in >20% of patients [FT 11/54 (20.4%) vs. tuned 12/37 (32%) patients]. Defibrillation threshold with RICD was greater and exhibited wider dispersion compared with left ICDs (n = 54) under similar conditions. CONCLUSION: This first randomized trial investigating DFTs with right ICDs confirms relatively higher DFTs with RICDs than reported for left pectoral ICDs. However, DFTs were generally unaffected by 3.5 ms time constant-based waveform tuning compared with a 50% tilt waveform. Implant testing may be preferred with RICDs. CLINICAL TRIAL NUMBER: NCT00873691.

Extraction of chronically implanted coronary sinus leads active fixation vs passive fixation leads.

BACKGROUND: The Medtronic model 4195 (StarFix) left ventricular lead is an active fixation lead that provides additional support within the coronary sinus (CS) via deployable lobes. While this lead has been shown to have excellent stability within the CS, concerns about its extractability have been raised. OBJECTIVE: The aim of this study was to compare the safety and efficacy of the extraction of the model 4195 lead vs other Medtronic CS leads in a prospective cohort study. METHODS: Patients undergoing extraction of this and other CS leads for standard indications were prospectively enrolled and studied. The primary outcomes of interest were the removal success rates and associated complication rates. Patients were followed for a month postprocedure. RESULTS: The overall left ventricular lead extraction success rate was 97.6% (n = 205). Among 40 patients with chronic model 4195 leads, there were 37 successful extractions (92.5%) as compared to 98.8% for the 165 non-4195 leads. However, in 2 of the 3 StarFix lead extraction failures, standard extraction techniques were not used. All 10 of the model 4195 leads that had been implanted for less than 6 months were extracted without incident. CONCLUSION: In this largest study of CS lead extractions published to date, the overall success rate of the extraction of chronically implanted CS leads is high and the complication rate is similar in these lead models. The extraction of the model 4195 lead is clearly more challenging, but it can be accomplished in high-volume extraction centers with experienced operators. It is recommended that the model 4195 lead be extracted by experienced operators.

Percutaneous Vacuum-Assisted Thrombectomy Device Used for Removal of Large Vegetations on Infected Pacemaker and Defibrillator Leads as an Adjunct to Lead Extraction.

This case series reports our early experience with a minimally invasive percutaneous method of safely removing large vegetations during lead extraction in septic cardiac implantable electronic devices (CIED). Debate exists concerning the management of vegetations involving these devices. Lead extraction is mandated for infections, but vegetations may embolize, causing complications. Surgical debridement is recommended; alternatives include cardiopulmonary bypass, minimally invasive thoracotomy, or transatrial approaches. The AngioVac device allows percutaneous right heart bypass and suction removal of vegetations under echocardiographic and fluoroscopic guidance. This case series describes our first 20 patients, all critically ill with persistent sepsis and vegetations despite long-term antibiotics. This series includes patients who would not have been eligible for alternative procedures due to contraindications and highlights the potential role of this new technology.

Multicenter experience with transvenous lead extraction of active fixation coronary sinus leads.

BACKGROUND/OBJECTIVE: Active fixation coronary sinus (CS) leads limit dislodgement and represent an attractive option to the implanter. Although extraction of passive fixation CS leads is a common and frequently uncomplicated procedure, data regarding extraction of chronically implanted active fixation CS leads are limited. METHODS: We performed a retrospective cohort study of patients undergoing active fixation CS lead extraction at six centers. Patient and procedural characteristics, indications for extraction, use of extraction sheath (ES) assistance, and outcomes are reported. RESULTS: Between January 2009 and February 2011, 12 patients underwent transvenous lead extraction (TLE) of Medtronic StarFix® lead (Medtronic Inc., Minneapolis, MN, USA). The cohort was 83% male with mean age 71 ± 14 years. Average implant duration was 14.2 ± 5.7 months (2.3-23.6). All leads but one were removed for infectious indications (67% systemic infection). At the time of explant, the fixation lobes were completely retracted in only one of the 12 cases and ES assistance was required for lead removal in all cases (58% laser, 25% cutting, 25% mechanical, and 25% femoral). The majority of cases required advancement of the sheath into the CS (75.0%) and often into a branch vessel (41.7%). One lead could not be removed transvenously and required surgical lead extraction. There were no major complications. Examination of the leads after extraction frequently revealed significant tissue growth into the fixation lobes. CONCLUSIONS: Although TLE of active fixation CS leads can be a safe procedure in select patients and experienced hands, powered sheaths and aggressive techniques are frequently required for successful removal despite relatively short implant durations. This raises significant concern regarding future TLE of active fixation CS leads with longer implant durations.