Maria Grazia Bongiorni

2015 ESC Guidelines for the management of infective endocarditis

3D : three-dimensional AIDS : acquired immune deficiency syndrome b.i.d. : bis in die (twice daily) BCNIE : blood culture-negative infective endocarditis CDRIE : cardiac device-related infective endocarditis CHD : congenital heart disease CIED : cardiac implantable electronic device

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

Assessment of Atrioventricular Junction Ablation and DDDR Mode-Switching Pacemaker Versus Pharmacological Treatment in Patients With Severely Symptomatic Paroxysmal Atrial Fibrillation A Randomized Controlled Study

BACKGROUND The purpose of the study was to evaluate the effect of AV junction ablation and pacemaker implantation on quality of life and specific symptoms in patients with paroxysmal atrial fibrillation (AF) not controlled by drugs. METHODS AND RESULTS We performed a multicenter, randomized, 6-month evaluation of the clinical effects of AV junction ablation and DDDR mode-switching pacemaker (Abl+Pm) versus pharmacological treatment in 43 patients with intolerable, recurrent paroxysmal AF of three or more episodes in the previous 6 months not controlled with three or more antiarrhythmic drugs. Before completion of the study, 3 patients in the drug group withdrew because of the severity of their symptoms and 1 patient assigned to the Abl+Pm group in whom the ablation procedure failed. At the end of the 6 months, the 21 patients of the Abl+Pm group who completed the study showed, in comparison with the 18 of the drug group, lower scores in the Living with Heart Failure Questionnaire (-51%, P=.0006), palpitations (-71%, P=.0000), effort dyspnea (-36%, P=.04), exercise intolerance score (-46%, P=.001), and easy fatigue (-51%, P=.02). The scores for rest dyspnea, chest discomfort, and NYHA functional classification were also lower (-56%, -50%, and -17%, respectively) in the Abl+Pm group, although not significantly. At the end of the study, palpitations were no longer present in 81% of the Abl+Pm group and in 11% of the drug group (P=.0000). AF was documented in 31 of 122 visits (25%) in the Abl+Pm group and in 9 of 107 examinations (8%) in the drug group (P=.0005); chronic AF developed in 5 (24%) and 0 (0%) in the two groups, respectively (P=.04). CONCLUSIONS In patients with paroxysmal AF not controlled by pharmacological therapy, Abl+Pm treatment is highly effective and superior to drug therapy in controlling symptoms and improving quality of life. The discontinuation of drug therapy exposes patients to further recurrences of paroxysmal AF and the risk of developing permanent AF.

A Leadless Intracardiac Transcatheter Pacing System

BACKGROUND A leadless intracardiac transcatheter pacing system has been designed to avoid the need for a pacemaker pocket and transvenous lead. METHODS In a prospective multicenter study without controls, a transcatheter pacemaker was implanted in patients who had guideline-based indications for ventricular pacing. The analysis of the primary end points began when 300 patients reached 6 months of follow-up. The primary safety end point was freedom from system-related or procedure-related major complications. The primary efficacy end point was the percentage of patients with low and stable pacing capture thresholds at 6 months (≤2.0 V at a pulse width of 0.24 msec and an increase of ≤1.5 V from the time of implantation). The safety and efficacy end points were evaluated against performance goals (based on historical data) of 83% and 80%, respectively. We also performed a post hoc analysis in which the rates of major complications were compared with those in a control cohort of 2667 patients with transvenous pacemakers from six previously published studies. RESULTS The device was successfully implanted in 719 of 725 patients (99.2%). The Kaplan-Meier estimate of the rate of the primary safety end point was 96.0% (95% confidence interval [CI], 93.9 to 97.3; P<0.001 for the comparison with the safety performance goal of 83%); there were 28 major complications in 25 of 725 patients, and no dislodgements. The rate of the primary efficacy end point was 98.3% (95% CI, 96.1 to 99.5; P<0.001 for the comparison with the efficacy performance goal of 80%) among 292 of 297 patients with paired 6-month data. Although there were 28 major complications in 25 patients, patients with transcatheter pacemakers had significantly fewer major complications than did the control patients (hazard ratio, 0.49; 95% CI, 0.33 to 0.75; P=0.001). CONCLUSIONS In this historical comparison study, the transcatheter pacemaker met the prespecified safety and efficacy goals; it had a safety profile similar to that of a transvenous system while providing low and stable pacing thresholds. (Funded by Medtronic; Micra Transcatheter Pacing Study ClinicalTrials.gov number, NCT02004873.).

Transvenous removal of pacing and implantable cardiac defibrillating leads using single sheath mechanical dilatation and multiple venous approaches: high success rate and safety in more than 2000 leads

Aims The aim of the present study was to describe a 10 years single-centre experience in pacing and defibrillating leads removal using an effective and safe modified mechanical dilatation technique. Methods and results We developed a single mechanical dilating sheath extraction technique with multiple venous entry site approaches. We performed a venous entry site approach (VEA) in cases of exposed leads and an alternative transvenous femoral approach (TFA) combined with an internal transjugular approach (ITA) in the presence of very tight binding sites causing failure of VEA extraction or in cases of free-floating leads. We attempted to remove 2062 leads [1825 pacing and 237 implantable cardiac defibrillating (ICD) leads; 1989 exposed at the venous entry site and 73 free-floating] in 1193 consecutive patients. The VEA was effective in 1799 leads, the TFA in 28, and the ITA in 205; in the overall population, we completely removed 2032 leads (98.4%), partially removed 18 (0.9%), and failed to remove 12 leads (0.6%). Major complications were observed in eight patients (0.7%), causing three deaths (0.3%). Conclusion Mechanical single sheath extraction technique with multiple venous entry site approaches is effective, safe, and with a good cost effective profile for pacing and ICD leads removal.

Image integration increases efficacy of paroxysmal atrial fibrillation catheter ablation: Results from the CartoMerge™ italian Registry

AIMS The aim of this study was to investigate whether circumferential pulmonary vein (PV) isolation guided by image integration improves the procedural and clinical outcomes of atrial fibrillation (AF) ablation in comparison with segmental PV isolation and circumferential PV isolation guided by three-dimensional (3D) electroanatomical mapping alone. METHODS AND RESULTS Procedural and clinical outcomes of 573 patients who underwent their first catheter ablation for paroxysmal AF between January 2005 and April 2007 were collected from 12 centres. We evaluated three techniques: segmental ostial PV isolation (SOCA group, 240 patients), circumferential PV isolation guided by electroanatomical mapping (CARTO group, 107 patients), and circumferential PV isolation guided by electroanatomical mapping integrated with magnetic resonance/computed tomographic images of the left atrium (MERGE group, 226 patients). Procedure duration proved to be shorter in MERGE group patients than in CARTO group patients (P < 0.04), but longer than in SOCA group patients (P < 0.0001). During follow-up, atrial tachyarrhythmias relapsed more frequently in SOCA group patients (44.6%) and CARTO group patients (41.7%) than in MERGE group patients (22.6%; P < 0.0001). CONCLUSION In patients with paroxysmal AF, circumferential PV isolation guided by image integration significantly improves clinical outcome in comparison with both circumferential PV isolation guided by 3D mapping alone and with segmental electrophysiologically guided PV isolation.

Coronary reserve and exercise ECG in patients with chest pain and normal coronary angiograms.

BackgroundCoronary vasodilator reserve is reduced in some patients with a history of chest pain and angiographically normal coronary arteries. ECG changes suggestive of myocardial ischemia during exercise also can be demonstrated in a subset of these patients. Methods and ResultsWe have investigated the correlation between coronary vasodilator reserve, assessed with 13N-labeled ammonia and positron emission tomography, and the ECG during exercise stress in 45 patients with a history of chest pain, angiographically normal coronary arteries, and a negative ergonovine test. ST segment depression on the ECG during exercise was present in 29 of 45 patients. Mean resting left ventricular blood flow was 1.04±0.22 ml · min−1 · g−1; it increased to 1.32±0.47 ml · min−1 g−1 (p<0.01 versus baseline value) during atrial pacing and to 2.52±0.96 ml · min−1 · g−1 (p<0.01 versus baseline value) after dipyridamole (0.56 mg/kg i.v.). No regional flow defects could be demonstrated in any patient during pacing or after dipyridamole. Myocardial flows after dipyridamole, however, did not show a normal frequency distribution (Kolmogorov-Smirnov test), and two patient populations could be identified. Twenty-nine (67%) patients had a mean left ventricular flow of 3.02±0.33 ml · min−1 · g−1 after dipyridamole (range, 2.13–5.46 ml · min−1 · g−1), and 14 (33%) patients had a mean flow of 1.48±0.29 ml · min−1 · g−1 (range, 1.06–2.04 ml · min−1 · g−1, p<0.01 versus the “high-flow group”). ConclusionsApproximately one third of patients in our series showed a reduced coronary vasodilator reserve. Although 12 of 14 patients in the “low-flow group” had ST segment depression during exercise stress, 16 of 29 patients in the high-flow group also had ST segment depression during exercise stress. Therefore, despite a good sensitivity (86%) in identifying patients with a blunted increment of coronary flow, the ECG response during exercise stress appears to have a rather low specificity (45%). This suggests that factors other than reduced coronary reserve and myocardial ischemia may play a role in the genesis of the ST segment depression in these patients.

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 …

Multicenter Experience With Extraction of the Sprint Fidelis Implantable Cardioverter-Defibrillator Lead

OBJECTIVES This study was undertaken to determine the safety and feasibility of extraction of the Sprint Fidelis (Medtronic, Minneapolis, Minnesota) lead. BACKGROUND The reported failure rate of the Sprint Fidelis defibrillator lead has increased to a range greater than initially appreciated with emerging evidence of an accelerating rate of fracture. At present, consensus guidelines continue to recommend against prophylactic extraction of the lead, citing major complication rates between 1.4% and 7.3%. However, data regarding the safety and feasibility of extraction of small-diameter, backfilled implantable cardioverter-defibrillator leads such as the Sprint Fidelis are limited. METHODS We performed a retrospective cohort study of consecutive patients undergoing extraction of Sprint Fidelis (models 6930, 6931, 6948, 6949) leads at 5 high-volume centers. Patient characteristics, indications for extraction, and use of countertraction sheath (CTS) assistance are reported. The risk of major and minor complications was determined. A multivariable logistic regression model was developed to predict factors associated with the use of CTS assistance. RESULTS Between May 2005 and August 2009, 349 Sprint Fidelis leads were extracted from 348 patients. All leads were removed completely. The average duration of the implanted lead was 27.5 months (range 0.03 to 58.8 months). Approximately one-half of the extracted leads were fractured (49.4%), and 26.5% were extracted prophylactically. The other major indication for extraction was infection (22.8%). Extraction was achieved with simple traction in 49.4% leads; CTS assistance was required in 174 cases (50.6%). In multivariable models, length of time since implantation was directly related to the need for CTS assistance (odds ratio per month since implantation: 1.035; 95% confidence interval: 1.010 to 1.061; p=0.006). There were no major procedural complications or deaths. CONCLUSIONS Extraction of the Sprint Fidelis lead can be performed safely by experienced operators at high-volume centers with a complication rate lower than that reported for older generation leads. However, leads with longer implant durations are associated with the use of CTS assistance. Recommendations regarding prophylactic Sprint Fidelis lead extraction may warrant reconsideration.