Cécile Romeyer-Bouchard

Prevalence and risk factors related to infections of cardiac resynchronization therapy devices

AIMS Device-related infections (DRI) are not well understood in patients implanted with a cardiac resynchronization therapy (CRT) device. The aims of this study were: (i) to evaluate the prevalence of CRT DRI; (ii) to establish the factors predictive of CRT DRI. METHODS AND RESULTS Between January 2001 and May 2007, CRT implantation was performed in 303 patients (247 men, 82%). The mean follow-up was 31 +/- 19 months. Population characteristics were a mean age of 70 +/- 10 years old; 56 female; aetiology includes (202 dilated and 101 ischaemic cardiomyopathy); NYHA class 3.2 +/- 0.3; LVEF (26 +/- 6%), and a QRS width of 171 +/- 31 ms. Thirteen patients developed a DRI: endocarditis in four, pocket erosion in three, pocket abscess in five, and septicaemia in one. The prevalence of DRI was 4.3%. By univariate analysis, predictive factors of DRI were: procedure time (skin to skin: median of 85 vs. 57.5 min; P = 0.03), re-intervention (54 vs. 6.5%; P < 0.0001), haematoma (31 vs. 8.6% P = 0.01), lead dislodgement (23 vs. 6.2%; P = 0.03), dialysis (23.1 vs. 1.72%; P = 0.003), and procedure type [CRT-ICD (8.6%) vs. CRT PM (1.6%) or system up-grade (1.5%); P = 0.03]. Significant correlations were found between re-intervention and lead dislodgement (r = 0.8; P < 0.001), haematoma (r = 0.2; P < 0.001). Four independent predictive factors of DRI were identified as procedure time (P = 0.002); dialysis (P = 0.0001); re-intervention (P = 0.006), and procedure type (CRT-ICD vs. other procedures; P = 0.01). CONCLUSION This study found that the prevalence of CRT DRI is close to 4.3% at 2.6 years (1.7% per year incidence). Four independent predictive factors of infections were identified including re-intervention, procedure time, dialysis, and primo CRT-ICD implantation. These parameters should be part of the risk-benefit evaluation in patients selected for CRT implantation.

Results From the Loire-Ardèche-Drôme-Isère-Puy-de-Dôme (LADIP) Trial on Atrial Flutter, a Multicentric Prospective Randomized Study Comparing Amiodarone and Radiofrequency Ablation After the First Episode of Symptomatic Atrial Flutter

Background— There is no published randomized study comparing amiodarone therapy and radiofrequency catheter ablation (RFA) after only 1 episode of symptomatic atrial flutter (AFL). The aim of the Loire-Ardèche-Drôme-Isère-Puy-de-Dôme (LADIP) Trial of Atrial Flutter was 2-fold: (1) to prospectively compare first-line RFA (group I) versus cardioversion and amiodarone therapy (group II) after only 1 AFL episode; and (2) to determine the impact of both treatments on the long-term risk of subsequent atrial fibrillation (AF). Methods and Results— From October 2002 to February 2006, 104 patients (aged 78±5 years; 20 women) with AFL were included, with 52 patients in group I and 52 patients in group II. The cumulative risk of AFL or AF was interpreted with the use of Kaplan-Meier curves and compared by the log-rank test. Clinical presentation, echocardiographic data, and follow-up were as follows: age (78.5±5 versus 78±5 years), history of AF (27% versus 21.6%); structural heart disease (58% versus 65%), left ventricular ejection fraction (56±14% versus 54.5±14%), left atrial size (43±7 versus 43±6 mm), mean follow-up (13±6 versus 13±6 months; P=NS), recurrence of AFL (3.8% versus 29.5%; P<0.0001), and occurrence of significant AF beyond 10 minutes (25% versus 18%; P=0.3). Five complications (10%) were noted in group II (sick sinus syndrome in 2, hyperthyroidism in 1, and hypothyroidism in 2) and none in group I (0%) (P=0.03). Conclusions— RFA should be considered a first-line therapy even after the first episode of symptomatic AFL. There is a better long-term success rate, the same risk of subsequent AF, and fewer secondary effects.

Comparison of the Efficacy of Cooled-Tip and 8-mm-Tip Catheters for Radiofrequency Catheter Ablation of the Cavotricuspid Isthmus: A Meta-Analysis

Background: Cooled‐tip RFA (cRFA) and conventional 8‐mm‐tip catheters were found to be more effective and as safe as conventional 4‐mm‐tip catheters for atrial flutter (AFL) radiofrequency ablation (RFA), facilitating the rapid achievement of bi‐directional isthmus block (BIB), but studies comparing cRFA and 8‐mm‐tip catheters are not randomized or results are discussed. Thus, we performed a meta‐analysis of available randomized trials to evaluate the effectiveness in terms of primary success and procedure parameters.

Predictive factors of difficult implantation procedure in cardiac resynchronization therapy.

AIMS The usefulness of cardiac resynchronization therapy (CRT) in patients with congestive heart failure is offset by its long, user-dependent, and technical procedure. No studies have been published regarding factors related to CRT implantation procedure duration and X-ray exposure. Additionally, only a few studies have investigated the predictive factors of primary left ventricular (LV) lead implant failure. The aim of this prospective study was two-fold: (i) to evaluate the prevalence and predictive factors of prolonged CRT implantation procedure and (ii) to identify the predictive factors of primary LV lead implantation failure. METHODS AND RESULTS Between November 2008 and September 2009, 128 consecutive patients underwent CRT implantation; of these, 22 patients (17.2%) were excluded because of CRT generator replacement. Population characteristics were a mean age of 69 +/- 10 years, 28.3% female, New York Heart Association class 3.2 +/- 0.3, LV ejection fraction (LVEF; 29 +/- 6%), and QRS width 146 +/- 23 ms. Cardiac resynchronization therapy implantation was attempted in 106 patients, and first LV lead implantation was obtained in 96 of 106 patients (90.5% primary success). Ten primary implantations failed (9.5%), due to unsuccessful LV lead implants. A second procedure was successfully attempted in six patients with a second more experienced operator (5.7%). Among the remaining four patients, one patient required a surgical epicardial LV lead implantation, and the implantation was not reattempted in the other three patients. The overall success rate of CRT system implantation was 96.2% (102 of 106 patients). Procedure parameters were as follows: LV threshold (1.4 +/- 0.9 V); LV wave amplitude (15 +/- 8 mV); LV impedance (874 +/- 215 ohm); median procedure time (skin to skin), 55 min (45-80); and median of procedure fluoroscopy time, 11 min (6.2-29). In 24 patients (22.6%), difficult procedures requiring >or=85 min of implantation duration occurred. By univariate analysis, predictive factors of difficult implantation were LV ejection fraction (25.6 +/- 6 vs. 30.2 +/- 8%; P = 0.02), LV end-diastolic diameter (72.4 +/- 11 vs. 66 +/- 11 mm; P = 0.01), LV end-systolic diameter (LVESD; 62 +/- 12 vs. 56 +/- 12 mm, P = 0.04), and the operators experience (very experienced operator vs. less experienced operator, P = 0.006). By multivariate analysis, only primary LV lead implantation failure, LVESD, and operators experience were independently associated with difficult procedures. In this patient subset with primary LV lead implant failure (n = 10), the only independent predictive factor was the LV end-systolic volume (P = 0.03). CONCLUSION In this study, the rate of difficult CRT device implantation procedures approached 25%. Both the degree of LV dysfunction and the operators experience were independent predictors of surgical difficulties. Left ventricular end-systolic volume was the only independent predictor of primary LV lead implant failure.

Safety and efficacy of radiofrequency ablation of common atrial flutter in elderly patients: a single center prospective study.

Little data is available concerning the invasive treatment of atrial flutter (AFL) in elderly patients. The purpose of this prospective study was to evaluate the risks, safety, and follow‐up of radiofrequency (RF) catheter ablation of common AFL in patients >75 years old (n = 61) (Group I) compared to patients younger than 75 years (n = 187) (Group II). The study population consisted of 248 patients (81% men/19% women), 21 to 96 years old (mean 66.3 ± 12 years) with AFL, referred for RF from June 1999 to June 2001. RF endpoint was the assessment of the bidirectional block. The cumulative risk of atrial fibrillation (AF) was analyzed by the Kaplan‐Meier method and log‐rank test. The mean follow‐up was 12.4 ± 9 months. No complication occurred. Group I (80.1 ± 4.5 years) did not differ significantly from Group II (61 ± 11 years) regarding: AF history before ablation (34.4% vs 39.8%), structural heart disease (54% vs 42%), LVEF (57%± 12% vs 58%± 12%), left atrial size (43.8 ± 7 vs 42.5 ± 7), cava‐tricuspid isthmus dimension (40 ± 10 vs 39 ± 4 mm), bidirectional block (100% vs 96.2%), RF application (12.5 ± 10 vs 13.5 ± 12 minutes), AFL recurrence (3.3% vs 5.3%), antiarrhythmic agents at hospital discharge (34.4% vs 38.9%), mean follow‐up (12 ± 9 vs 13 ± 9 months) and AF occurrence (29.5% vs 20.3%; P = 0.2). Of these, the incidence of AF in patients without prior history (n = 150) was 7 (18%) of 39 for Group I and 11 (10%) of 111 for Group II (P = 0.1) after follow‐up. Catheter ablation of AFL in very elderly patients appears to be a reasonable approach regarding feasibility, effectiveness, and low procedural risk. (PACE 2003; 26:1729–1734)

Anatomical factors involved in difficult cardiac resynchronization therapy procedure: a non-invasive study using dual-source 64-multi-slice computed tomography.

AIMS In cardiac resynchronization therapy (CRT) procedure, left ventricular (LV) lead implantation is time consuming. In this clinical setting, no study has investigated the impact of right atrium anatomical parameters on both CRT implantation procedure duration and X-ray exposure. Additionally, only few studies have examined the coronary sinus (CS) using dual-source 64-multi-slice computed tomography (DS 64-MSCT), and its impact on CRT procedure parameters has not yet been investigated. The aim of this prospective study was to identify local anatomical predictive factors of difficult CRT implantation procedure using DS 64-MSCT. METHODS AND RESULTS Between January and July 2010, 50 consecutive patients underwent primo CRT implantation. The patient population had a mean age of 70 ± 10 years, and was 34% female, with New York Heart Association Class 3.2 ± 0.3 heart failure, left ventricle ejection fraction 30 ± 4%, and QRS width 157 ± 30 ms. Cardiac resynchronization therapy implantation was attempted in 50 patients, and first LV lead implantation was obtained in 49 of 50 patients (98% primary success). One implantation failed (2%) due to unsuccessful LV lead implant. Procedure parameters were as follows: LV threshold, 1.4 ± 0.8 V; LV wave amplitude, 17 ± 8 mV; LV impedance, 830 ± 240 Ω; median procedure time (skin to skin), 51 min (38 min); median fluoroscopy procedure time, 11.9 min (22 min); and median LV fluoroscopic time, 10.3 min (22 min). In 10 patients (20%), procedures were difficult requiring an implantation lasting ≥ 85 min. The only predictive factor for difficult CRT implantation was the insertion level of the CS ostium (CSO), evaluated by the distance between the CSO and the bottom floor of the right atrium (14.8 ± 4 vs. 9.5 ± 4; P= 0.01). Neither the right atrium dilation nor right ventricular dysfunction was associated with difficult CRT implantation procedures. CONCLUSIONS Today, despite improvements in the materials used, problems still remain in the CRT procedure. In this clinical setting, the only predictive factor for very long CRT procedures is the CSO-level insertion (located high). This anatomical anomaly identified by DS 64-MSCT prior to surgery is responsible for 20% of difficult CRT device implantation procedures.

Anatomic and Electrophysiological Differences Between Chronic and Paroxysmal Forms of Common Atrial Flutter and Comparison with Controls

Whether chronic typical atrial flutter differs from paroxysmal atrial flutter regarding electrophysiological properties of reentry pathways and cardiac function remains unknown. If so, can remodeling due to long duration of persistently rapid atrial or ventricular rates explain these changes? The aim of the study was to compare RA local conduction velocities and heart function parameters between three groups: (1) chronic atrial flutter, (2) paroxysmal atrial flutter, and (3) controls. The study evaluated 52 patients undergoing radiofrequency ablation for typical atrial flutter. There were 35 patients with chronic atrial flutter (62.7 ± 14 years) and 17 patients with paroxysmal atrial flutter (62.7 ± 10 years). Underlying structural heart disease was present in 20 (57%) of 35 chronic atrial flutter patients and in 7 (41%) of 17 paroxysmal atrial flutter patients (P = 0.1). Chronic atrial flutter duration was 10.9 ± 17 months and paroxysmal atrial flutter duration was 8.5 ± 10 (P = 0.06). RA conduction velocity measurements were carried out before ablation during sinus rhythm under pacing (600‐ms cycle length) with a 12‐pole steerable catheter positioned in the high lateral RA (poles 11‐12 [H6]), mid‐lateral RA (poles 9‐10 [H5]), and along the inferior vena caval tricuspid isthmus (poles 7‐8 [H4]; 5‐6 [H3]; 3‐4 [H2]) with its distal electrode pair at the coronary sinus origin (pole 1‐2 [H1]). Counter‐clockwise RA conduction velocities were assessed from H6 to H1 and clockwise RA conduction velocities from H1 to H6. After successful ablation, RA and LA areas, LV volumes, LVEF, inferior vena caval tricuspid annulus, and coronary sinus tricuspid annulus (septal isthmus) lengths were measured by two‐dimensional echocardiography. The control group included 12 patients without structural heart disease, referred for electrophysiological evaluation of AVN reentry. Counter‐clockwise RA conduction velocities at the inferior vena caval tricuspid isthmus were lower in chronic atrial flutter than in paroxysmal atrial flutter (H4, 1.19 ± 0.4 vs 1.89 ± 1 m/s, P = 0.0051; H3, 1.14 ± 0.4 vs 1.6 ± 0.7 m/s, P = 0.0015; H2, 1.16 ± 0.4 vs 1.53 ± 0.5 m/s, P < 0.0056 and H1, 1.2 ± 0.4 vs 1.5 ± 0.4 m/s, P = 0.03, respectively). Counter‐clockwise RA conduction velocities were identical at the high and mid‐lateral RA. Counter‐clockwise caval isthmus RA conduction velocities from H3 to H1 were significantly different between chronic atrial flutter and controls (H3, 1.14 ± 0.4 vs 1.7 ± 0.3 m/s, P = 0.0014; H2, 1.16 ± 0.4 vs 1.83 ± 0.4 m/s, P < 0.0001 and H1, 1.2 ± 0.4 vs 1.94 ± 0.4 m/s, P < 0.0001, respectively). A difference was found regarding clockwise isthmus RA conduction velocities between the two groups of atrial flutter and controls but not between chronic atrial flutter and paroxysmal atrial flutter. Respectively, chronic atrial flutter had greater RA and LA areas (24.5 ± 5 vs 13 ± 2 cm 2 ; P < 0.0001 and 23 ± 5 vs 16 ± 3 cm 2 , P < 0.0001), LV end‐systolic and end‐diastolic volumes (50 ± 25 vs 32 ± 13 cm 3 , P = 0.0084 and 112 ± 40 vs 85 ± 25 cm 3 , P = 0.01), septal isthmus length (21 ± 3 vs 13 ± 2 mm, P < 0.0001), and inferior vena caval tricuspid isthmus length (39 ± 6 vs 23 ± 5 mm; P < 0.0001). Chronic common atrial flutter is characterized by more prolonged counter‐clockwise conduction times and larger anatomic conduction pathways than the paroxysmal form, the causal relationship between electrophysiological and anatomic characteristics remains to be demonstrated.

Clinical impact of the implantable loop recorder in patients with isolated syncope, bundle branch block and negative workup: A randomized multicentre prospective study

BACKGROUND Few studies have compared conventional testing with prolonged monitoring using an implantable loop recorder (ILR) following the first syncope episode in patients with bundle branch block (BBB) and negative workup. OBJECTIVES To compare two syncope evaluation strategies-primary use of an ILR (Group 1) versus conventional testing (Group 2)-and to estimate the prevalence of significant arrhythmias in the ILR patient subset. METHODS From January 2005 to December 2010, 78 patients admitted after one syncope episode were randomized to ILR (n=41) or conventional follow-up (n=37). Mean follow-up was 27 ± 12 months. RESULTS Mean age was 76 ± 8 years and 30 patients were women (38.5%); 18 presented cardiomyopathy (23%) and 12 had a history of atrial fibrillation (15.4%). Mean left ventricular ejection fraction was 56.5 ± 11% and mean His-to-ventricle interval was 55 ± 6ms based on negative electrophysiological study (EPS). Electrocardiogram abnormalities involved: 34 left bundle branch blocks (BBBs); 11 right BBBs; and 33 bifascicular blocks. Overall, 21 patients (27%) developed significant arrhythmic events: ventricular tachycardia (n=1; 1.3%); sudden death (n=2; 2.6%); third-degree atrioventricular (AV) block (n=14; 18%); sick sinus syndrome (n=4; 5.1%). In 19 (24.4%) patients, relevant arrhythmias were detected, with a significant difference between the ILR group (n=15/41; 36.6%) and the conventional follow-up group (n=4/37; 10.8%) (P=0.02). Eighteen patients were implanted with pacemakers; one received an implantable defibrillator. No predictors of AV block were identified in the ILR group. CONCLUSIONS In this randomized prospective study, the ILR strategy proved largely superior to conventional follow-up in detecting recurrent events, with a potential impact on therapeutic management. This observation highlights the usefulness of early monitoring in patients with BBB and negative EPS even after the first syncope episode but an empiric pacemaker strategy remains to be validated in this selected population.

Transcatheter leadless cardiac pacing: The new alternative solution

INTRODUCTION A lack of information about the feasibility and safety of leadless pacemaker (LPMs) exists in a fragile population of patients with limited venous anatomy access or conventional pacemaker (PM) contraindication. Accordingly, the goal of this prospective observational study was to report our experience with this new leadless technology in a subset of patients with contraindication or limited venous access. METHODS AND RESULTS Between May 2015 and July 2016, 14 patients were consecutively included. The indications for initial PM implantation were atrioventricular (AV) block in 10/14 patients (71%), bradyarrhythmia in one (7%), and uncontrolled atrial fibrillation (AFib) requiring AV-node ablation in three (21.5%). AFib was observed in 9 of the 14 patients (64.3%) and 3 were completely dependent with no escape rhythm (21.5%). Normal access pathways via the right or left subclavian veins were occluded due to previous PM implantations and revisions in 4 patients (28.6%) and total vena cava occlusion in 3 (21.4%). End-stage renal disease with hemodialysis was present in 8 (57%) with either local-device infections or presence of long-term implanted dialysis catheters. Evidence of previous bilaterally-infected pectoral tissue was present in 3 patients (21.5%). All procedures were successful (100%) and electrical parameters remained stable over time. No direct pacemaker-related adverse events were reported, including mechanical complications, except for one ventricular fibrillation one day post-implantation under very specific conditions. CONCLUSION This series demonstrated very stable performance and reassuring safety results during mid-term follow-up in a very fragile population requiring a PM. The Micra LPM constitutes an excellent alternative to the epicardial surgical approach in this very fragile population.

Preoperative skin antiseptics for prevention of cardiac implantable electronic device infections: a historical-controlled interventional trial comparing aqueous against alcoholic povidone-iodine solutions.

AIMS Local skin antiseptic prevention against cardiac implantable electronic device (CIED) infections is not yet fully understood. This monocentre historical-controlled study sought to (i) conduct a prospective observational analysis comparing two antiseptic skin preparations over two similar consecutive periods of time, one conducted over a 1-year period using an aqueous povidone-iodine solution (Group I) and the other over the following with an alcoholic povidone-iodine solution (Group II); (ii) determine the predictive factors of CIED infection. METHODS AND RESULTS Cardiac implantable electronic device implantation was performed in 1326 patients (pts). A total of 32 pts (2.4%) developed a CIED infection. Long-term follow-up (26 ± 3 months) revealed no significant difference between the groups: infections were observed in 14 of the 648 pts (2.2%) in Group I vs. 18 of the 678 pts (2.7%) in Group II (P = 0.9). Single- and multiple-variable logistic regression analyses were performed to identify risk factors; adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were calculated. The occurrence of infection was positively correlated with re-intervention (aOR, 7.16; 95% CI, 2.56-19.99; P < 0.0001), number of generator replacements, mean (aOR, 3.47; 95% CI, 2.22-5.44; P < 0.001), and haematoma (aOR, 48.4; 95% CI, 13.45-174.25; P < 0.0001). CONCLUSION This study found that aqueous and alcoholic povidone-iodine solutions displayed similar antiseptic effects regarding CIED infection prevention. Independent predictive factors of CIED infection were re-intervention, haematoma, and number of generator replacements.