Charles Kennergren

Transvenous Lead Extraction: Heart Rhythm Society Expert Consensus on Facilities, Training, Indications, and Patient Management: This document was endorsed by the American Heart Association (AHA)

Cleveland Clinic, Department of Cardiovascular Medicine, Cleveland, OH, Ohio State University, Division of ardiovascular Medicine, Columbus, OH, Broward General Medical Center, Fort Lauderdale, FL, University Hospital, ivision of Cardiovascular Medicine, Pisa, Italy, University of Miami, Cardiothoracic Surgery, Miami, FL, St. Thomas esearch Institute, University of Tennessee College of Medicine, Nashville, TN, Brigham and Women’s Hospital, Boston, A, **Baylor College of Medicine, Pediatrics and Texas Children’s Hospital, Houston, TX, Sahlgrenska University ospital, Gothenburg, Sweden, University of Medical Sciences, Poznan, Poland, Providence St. Joseph Medical enter, Burbank, CA, American Heart Association Representative.

Superior vena cava defibrillator coils make transvenous lead extraction more challenging and riskier

To the Editor: Studies have demonstrated equivalent defibrillation efficacy and all-cause mortality in patients with single and dual coil implantable cardioverter-defibrillator (ICD) leads ([1,2][1]). Despite this equivalency, the vast majority of implanted ICD leads are dual coil ([3][2]). The

A single-centre experience of over one thousand lead extractions

AIMS The aim of the study was to present a single-centre experience of pacemaker and implantable cardioverter defibrillator (ICD) lead extraction using different methods, mainly laser-assisted extraction. METHODS AND RESULTS Data from 1032 leads and 647 procedures were gathered. A step-by-step approach using different techniques while performing an ongoing risk-benefit analysis was used. The most common indications were local infection, systemic infection, non-functional lead, elective lead replacement, and J-wire fracture. Mean implantation time for all leads was 69 months and for laser-extracted leads 91 months. Laser technique was used to extract 60% of the leads, 29% were manually extracted, 6% extracted with mechanical tools, 4% were surgically removed, and 0.6% extracted by a femoral approach. Failure rate was 0.7%, and major complication rate was 0.9%. No extraction-related mortality occurred. Median time for laser extraction was 2 min. Long implantation time was not a risk factor for failure or for complication. CONCLUSION Pacing and ICD leads can safely, successfully, and effectively be extracted. Leads can often be extracted by a superior transvenous approach; however, open-chest and femoral extractions are still required. Laser-assisted lead extraction proved to be a useful technique to extract leads that could not be removed by manual traction. The results indicate that the paradigm of abandoning redundant leads, instead of removing them, may have to be reconsidered.

Automatic Adjustment of Pacemaker Stimulation Output Correlated with Continuously Monitored Capture Thresholds: A Multicenter Study

Pacing threshold is affected by many factors. A pacing system able to confirm capture at each beat and automatically adjust its output close to the actual pacing threshold is highly desirable. This study evaluates the safety and efficacy of the Autocapture function of the Pacesetter Microny SR+. One hundred thirteen patients were recruited from 16 centers in 7 European countries and followed up for 1 year. All pacemakers were implanted with Pacesetters low polarization, bipolar leads. The key feature of Autocapture is the immediate delivery of a 4.5 V safety backup pulse 62.5 ms after any ineffective ongoing low output pulse. Holter recordings confirmed total reliability of this feature without any exit block. The measured evoked response (ER) signal was stable over time. Acute and chronic pacing thresholds measured by VARIO and Autocapture tests correlated (r > 0.79) over the period of the study. The incidence of backup pulses was 1.1% during pacing. With Autocapture programmed ON, the overall total current consumption was 4.1 μA for VVI and 5.0 μA for VVIR pacing. Tbis study proved that the Autocapture safely and reliably regulates the pacemakers output according to the prevailing threshold thus providing maximum patient safety and prolonging service life.

Pathways for training and accreditation for transvenous lead extraction: a European Heart Rhythm Association position paper.

### Introduction The European Heart Rhythm Association charged the present writing committee with the task of producing a consensus document on training and accreditation for transvenous extraction of chronically implanted pacing and defibrillator leads.1,2 The core curriculum for the European Heart Rhythm Specialist includes implantation of heart rhythm devices but does not specifically mandate learning and accreditation for extraction techniques.3 The lack of such recommendations is related to the limited number of extractions available for training purposes and attaining competency. The present document focuses on the rising burden and the increasing complexity of techniques of lead extraction with an emphasis on the critical issues of training, accreditation, and documentation of results. There is also an educational component felt necessary to include by the Task Force in view of the specialized and emerging nature of this field. Where appropriate, a European perspective is presented and paediatric aspects are treated separately. The aim is to complement two recently published documents, one from the Heart Rhythm Society (HRS)4 on facilities, training, indications, and management of transvenous lead extraction and the other from the American Heart Association on device-related infections.5 The indications for lead extraction have not changed since these publications and are therefore not covered in this present document. ### Need for lead extraction/removal—a European perspective Due to improving recognition of clinical need and wider indications, the implant rate of Cardiovascular Implantable Electronic Devices (CIED) continues to rise in most countries.6,7 The number of leads per patient is increasing with cardiac resynchronisation therapy–pacemaker/defibrillator, upgrades and a higher proportion of dual vs. single-chamber devices. As life expectancy has risen, so have the number of generator and lead changes despite advances in technology. Product advisories are inevitable despite overall improvements in reliability and have led to surges in extraction.8–10 Currently, infection accounts …

Pacemaker endocarditis during 18 years in Göteborg.

Pacemaker endocarditis is a rare but serious complication. Few studies addressing its treatment have been published. Clinical characteristics and outcome were retrospectively studied in 38 patients with 44 episodes of pacemaker infective endocarditis (PMIE) in Göteborg, during 1984–2001. The male/female ratio of episodes was 27/17 and the mean age 69 y. Transthoracic echocardiography (TTE) showed vegetation in 4/22 (18%) episodes and transoesophageal echocardiography (TEE) in 22/33 (67%). Staphylococci were isolated in 66% of blood cultures. The pacemaker system (PS) was removed in 28 episodes and in 18 of these there were no signs of reinfection at follow-up. In 16 episodes the PS was not removed, and in 13 of these, signs of infection were found at follow-up. Thus, the present study of PMIE showed staphylococci to be predominant causative agents and demonstrated a high diagnostic sensitivity of TEE. According to our results, PM removal rather than conservative treatment should be considered in all cases.

Excimer Laser assisted extraction of permanent pacemaker and ICD leads: present experiences of a European multi-centre study

OBJECTIVE Excimer Laser technique can be used to extract leads. We present the European multi-centre experience. METHOD The Spectranetics Excimer Laser is a Xenon-Chloride laser with a wavelength of 308 nm, not visible to the human eye. This cool cutting laser (50 degrees C) has an absorption depth of 0.06 mm. The laser energy is emitted from the tip of flexible 12, 14 or 16 French (Fr) probes and is absorbed by proteins and lipids. The fibrotic sheaths usually surrounding leads can be cut without damaging the endothelial wall or the insulation of other leads. RESULTS From August 1996 to August 1998, 179 leads (104 atrial, 57 ventricular, one SVC, 17 ICD) in 149 patients (mean age 68.3 years, range 14-94) were extracted in 11 centres. Mean implantation time was 68.3 months (2.8-357.8). Most common indications were patient morbidity, non-function, pocket infection, septicaemia or endocarditis. Median extraction time was 10 min (1-189). Most procedures (78%) were performed in operating rooms. Complete extraction was achieved in 89.5% of the leads, 6% were partially extracted and 4.5% of the extractions failed. In the majority of the partial cases, only minor lead parts without clinical significance were left. Of the failures, 3/8 were completely removed by femoral non-laser approach, 1/8 with a right subclavian approach and 1/8 with thoracotomy. Complications were few but included one ventricular perforation that did not need surgery; two other perforations were related to the reimplantation of leads and required surgery. Mean hospital stay was 3 days and all patients were discharged well and alive. CONCLUSIONS Excimer Laser assisted lead extraction is a safe and efficacious procedure. Open-chest extractions are still necessary but can be limited to very selected cases. These initial results may widen indications from mandatory to include the extraction of many non-functional leads, previously abandoned.

2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction

Fred M. Kusumoto, MD, FHRS, FACC, Chair, Mark H. Schoenfeld, MD, FHRS, FACC, FAHA, CCDS, Vice-Chair, Bruce L. Wilkoff, MD, FHRS, CCDS, Vice-Chair, Charles I. Berul, MD, FHRS, Ulrika M. Birgersdotter-Green, MD, FHRS, Roger Carrillo, MD, MBA, FHRS, Yong-Mei Cha, MD, Jude Clancy, MD, Jean-Claude Deharo, MD, FESC, Kenneth A. Ellenbogen, MD, FHRS, Derek Exner, MD, MPH, FHRS, Ayman A. Hussein, MD, FACC, Charles Kennergren, MD, PhD, FETCS, FHRS, Andrew Krahn, MD, FRCPC, FHRS, Richard Lee, MD, MBA, Charles J. Love, MD, CCDS, FHRS, FACC, FAHA, Ruth A. Madden, MPH, RN, Hector Alfredo Mazzetti, MD, JoEllyn Carol Moore, MD, FACC, Jeffrey Parsonnet, MD, Kristen K. Patton, MD, Marc A. Rozner, PhD, MD, CCDS, Kimberly A. Selzman, MD, MPH, FHRS, FACC, Morio Shoda, MD, PhD, Komandoor Srivathsan, MD, Neil F. Strathmore, MBBS, FHRS, Charles D. Swerdlow, MD, FHRS, Christine Tompkins, MD, Oussama Wazni, MD, MBA

Current practice in transvenous lead extraction: a European Heart Rhythm Association EP Network Survey

AIM Current practice with regard to transvenous lead extraction among European implanting centres was analysed by this survey. METHODS AND RESULTS Among all contacted centres, 164, from 30 countries, declared that they perform transvenous lead extraction and answered 58 questions with a compliance rate of 99.9%. Data from the survey show that there seems to be an overall increasing experience of managing various techniques of lead extraction and a widespread involvement of cardiac centres in this treatment. Results and complication rates seem comparable with those of main international registries. CONCLUSION This survey gives an interesting snapshot of lead extraction in Europe today and gives some clues for future research and prospective European registries.

Monitoring of Extracellular Aspartate Aminotransferase and Troponin T by Microdialysis during and after Cardioplegic Heart Arrest

This study aims at developing per- and postopertive surveillance of the myocardium and focuses on ischemic damage following cardioplegic heart arrest. Levels of troponin T and total aspartate aminotransferase (ASAT) were analyzed in the myocardial interstitium of 10 patients with ischemic heart disease (IHD) who underwent coronary bypass surgery and in 12 patients with nonischemic heart disease (N-IHD) who underwent valvular surgery. Fluid from the myocardial interstitium of the anterior and the lateral wall of the heart was sampled by microdialysis probes that were implanted during surgery and extracted percutaneously 70–100 h later. There were no adverse reactions, and the equipment did not interfere with the surgical procedures. The peak in troponin T serum levels that occurred 4 h after cardiac arrest was preceded by a peak in troponin T levels in the microdialysates from the interstitium that occurred 1 h earlier. The concentration of troponin T in the microdialysate peak was 300 times higher than in the serum peak. The increase in serum ASAT levels during the first 7 h after cardiac arrest corresponded in time with a decrease in interstitial ASAT levels, which had already reached a maximum during cardiac arrest. The microdialysate/serum concentration ratio was considerably smaller for ASAT than for troponin T. Interstitial peak levels of troponin T correlated positively and significantly with peak levels of ASAT. Of the 22 patients, 15 had no postoperative events according to clinical outcome, ECG and serum tests. Fourteen of these had low to normal levels of interstitial ASAT and troponin T. Conversely, atrial fibrillation and/or premature atrial contractions were recorded in 8/22 patients, 7 of whom had elevated interstitial ASAT and/or troponin T concentrations in one or both of the sampled heart regions. The N-IHD patients had higher levels of troponin T in the interstitium 20–70 h following cardioplegia, while the peak levels did not differ between the groups. In conclusion, microdialysis sampling of troponin T and ASAT is safe and allows a highly sensitive analysis of the ischemic trauma exerted by the cardioplegic arrest.