Publications by authors named "Cécile Romeyer-Bouchard"

31 Publications

Impact of sacubitril/valsartan on echo parameters in heart failure patients with reduced ejection fraction a prospective evaluation.

Int J Cardiol Heart Vasc 2019 Dec 3;25:100418. Epub 2019 Sep 3.

Division of Cardiology, Jean Monnet University, Saint-Etienne, France.

Background: Sacubitril/valsartan has been shown to improve mortality and reduce hospitalizations in patients with heart failure (HF) with reduced ejection fraction (HFrEF). Although the physiological action mechanisms of sacubitril/valsartan are well described, its effects on left ventricular (LV) remodelling and other echocardiographic (echo) parameters have not been prospectively studied.

Objective: The aim of this prospective study was to: McMurray et al. (2012) [1] evaluate if sacubitril/valsartan impacts LV remodelling based on echo parameters; Ponikowski et al. (2016) [2] identify the predictive factors of sacubitril/valsartan response or intolerance.

Methods: From May 2017 to September 2018, 52 HF patients were prospectively enrolled using PARADIGM-HF criteria: Class II, III, or IV HF; ejection fraction (EF) of 40% or less; hospitalized for HF within the previous 12 months. Echo evaluation was performed before initiating sacubitril/valsartan and 3 months after optimal dose adjustment. Based on previous studies, patients with (absolute) improvement in left ventricular ejection fraction (LVEF) ≥ 5% were considered significant sacubitril/valsartan responders.

Results: The 52 patients completing the study were characterized by age: 70 ± 10 years; gender: 11women; aetiology: idiopathic in 20 and ischaemic in 32; NYHA Class: II in 17 and III in 35; LVEF: 32 ± 5%; NTProBNP: 1805 ± 1914 pg/mL. The final population comprised 41 pts (79%), as 11 (21%) did not tolerate sacubitril/valsartan therapy. Under sacubitril/valsartan, several echo parameters significantly improved: LVEF from 32.6 ± 5 to 36 ± 6% ( < 0.0001); LVES volume from 117 ± 40 to 108 ± 46 mL ( = 0.0051); SEV from 59 ± 12 to 64 ± 13 ( = 0.0061); LVEDD from 60 ± 4 to 57 ± 5 mm ( = 0.0002); mean right ventricular systolic pressure (RVSP) from 39 ± 10 to 32 ± 8 ( = 0.0001). No significant modifications were observed concerning LV diastolic parameters or RV echo parameters. Sacubitril/valsartan echo responders (n = 18/41; 42%) had less severe LV remodelling, as shown by LVEDV: 144 ± 37 vs. 193 ± 47 mL,  = 0.0009; LVESV: 96 ± 28 vs. 133 ± 42 mL;  = 0.003; LVTDD: 61 ± 4 vs. 57 ± 5 mm;  = 0.02; significant mitral regurgitation: 6/18 (33%) vs. 16/23 (69%),  = 0.02; no diastolic LV or RV parameters impacted sacubitril/valsartan response. Predictors of sacubitril/valsartan intolerance were baseline creatinine level: 137 ± 99 vs. 100 ± 24,  = 0.03; LVEF: 29 ± 6 vs. 33 ± 5%;  = 0.04.

Conclusions: In HFrEF patients, sacubitril/valsartan significantly improves LV systolic remodelling, without any significant effects on LV diastolic or RV systolic echo parameters. Sacubitril/valsartan responders exhibit both less severe LV remodelling and less significant mitral regurgitation. Accordingly, sacubitril/valsartan could be used as soon as possible in HFrEF patients in order to limit LV remodelling, while precluding non-response or intolerance.
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http://dx.doi.org/10.1016/j.ijcha.2019.100418DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6728827PMC
December 2019

Comparison of prevalence and management of left atrial appendage thrombi under old and new anticoagulants prior to left atrial catheter ablation.

Am Heart J 2017 Nov 2;193:8-15. Epub 2017 Aug 2.

Division of Cardiology, Jean Monnet University (ADC, CD, JBG, AG, RP, CRB, and KI), Saint-Etienne, France.

Background: The prevalence and management of left atrial appendage (LAA) thrombi associated with new anticoagulants remain to be elucidated, especially prior to atrial fibrillation (AFib) ablation. This study sought to (1) compare the prevalence of LAA thrombi and/or severe LAA contrast under vitamin K antagonist (VKA) agents and novel oral anticoagulants (NOACs), (2) evaluate the rate of LAA thrombus resolution after anticoagulation modification, and (3) determine the predictive factors of LAA thrombi and severe LAA contrast in patients prior to LA AFib ablation.

Methods: Between January 2013 and March 2016, 576 consecutive patients referred for AFib ablation were included, and the prevalence of transesophageal echocardiography-detected thrombi was similar under NOACs (2.1%) and VKA agents (2.6%).

Results: Thrombus resolution was obtained in 50% of cases following anticoagulation modification. Through multivariate exact logistic regression analysis with relevant clinical and echocardiographic features, age (P<.001), LAA hypocontractility (P<.001), and left ventricular ejection fraction (P=.007) were found to be independently associated with the occurrence of LAA thrombus. The relevant factors independently associated with LAA thrombus or severe contrast were LAA hypocontractility (P<.001) and age (P<.001).

Conclusions: The prevalence of transesophageal echocardiography-detected thrombi in patients referred for AFib ablation is similar under NOACs (2.1%) and VKA agents (2.6%). Under VKA therapy with 3-4 international normalized ratio, 50% of thrombi dissolved. Independent predictive factors of procedure contraindication included age, LAA hypocontractility, and left ventricular ejection fraction.
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http://dx.doi.org/10.1016/j.ahj.2017.07.016DOI Listing
November 2017

Substantial superiority of Niobe ES over Niobe II system in remote-controlled magnetic pulmonary vein isolation.

Int J Cardiol 2017 Mar 22;230:319-323. Epub 2016 Dec 22.

Division of Cardiology, Jean Monnet University, Saint-Etienne, France.

Background: Catheter ablation of atrial fibrillation (AFib) primarily relies upon pulmonary vein isolation (PVI), but such procedures are associated with significant X-ray exposure. The newer Epoch system has been developed so as to enable more precise magnetic navigation whilst limiting X-ray exposure.

Objectives: This study was aimed at quantifying both exposure time and X-ray reduction with the newer Epoch system compared to Niobe II during AFib ablation procedures.

Methods: From November 2011 to November 2013, our last 92 consecutive patients treated with the Niobe ES (Epoch Solution; 4th generation magnetic navigation technology) system were compared with the first 92 consecutive patients treated using the Niobe II system (3rd generation magnetic navigation technology) for symptomatic drug-refractory AFib.

Results: Mean patient age was 59±11years (20% female), and the study population was affected by either symptomatic paroxysmal (65.2%) or persistent (34.8%) AFib. Median procedure time was 2±0.5h and median total X-ray exposure 12.3±6.4min. Procedure time (1.9±0.4 vs. 2.7±1h, p<0.0001) and X-ray duration (12±4 vs. 15±7min, p=0.001) were significantly lower with Niobe ES than with the Niobe II system. X-ray ablation exposure time was also significantly lower with the Niobe ES system than with the Niobe II system (2.9±2 vs. 4±3.5min; p=0.01). Through multivariate analysis, the only predictive factors influencing both procedure duration and X-ray exposure were found to be the Niobe ES system use and LA size.

Conclusions: Our study was the first to demonstrate that the new Niobe ES magnetic robotic system substantially reduced overall operating, fluoroscopy, and ablation times during AFib ablation procedure.
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http://dx.doi.org/10.1016/j.ijcard.2016.12.115DOI Listing
March 2017

Transcatheter leadless cardiac pacing: The new alternative solution.

Int J Cardiol 2017 Jan 9;227:122-126. Epub 2016 Nov 9.

Division of Cardiology, Jean Monnet University (ADC, AA, CRB, LA, ZA, JBG, AG, and KI), Saint-Etienne, France.

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.
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http://dx.doi.org/10.1016/j.ijcard.2016.11.196DOI Listing
January 2017

Robotic magnetic navigation for ablation of human arrhythmias.

Med Devices (Auckl) 2016 19;9:331-339. Epub 2016 Sep 19.

North Hospital, Cardiology Department University of Saint Etienne Jean Monnet, Saint Etienne Cedex 2, France.

Radiofrequency treatment represents the first choice of treatment for arrhythmias, in particular complex arrhythmias and especially atrial fibrillation, due to the greater benefit/risk ratio compared to antiarrhythmic drugs. However, complex arrhythmias such as atrial fibrillation require long procedures with additional risks such as X-ray exposure or serious complications such as tamponade. Given this context, the treatment of arrhythmias using robotic magnetic navigation entails a technique well suited to complex arrhythmias on account of its efficacy, reliability, significant reduction in X-ray exposure for both patient and operator, as well as a very low risk of perforation. As ongoing developments will likely improve results and procedure times, this technology will become one of the most modern technologies for treating arrhythmias. Based on the literature, this review summarizes the advantages and limitations of robotic magnetic navigation for ablation of human arrhythmias.
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http://dx.doi.org/10.2147/MDER.S96167DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5034914PMC
September 2016

Is the new Micra-leadless pacemaker entirely safe?

Int J Cardiol 2016 Jun 18;212:97-9. Epub 2016 Mar 18.

Division of Cardiology, Jean Monnet University, Saint-Etienne, France.

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http://dx.doi.org/10.1016/j.ijcard.2016.03.065DOI Listing
June 2016

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

Europace 2015 Jul 26;17(7):1092-8. Epub 2015 Apr 26.

The Division of Cardiology, University Jean Monnet of Saint-Etienne, Saint-Etienne F-42000, France.

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.
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http://dx.doi.org/10.1093/europace/euu293DOI Listing
July 2015

Remote-controlled magnetic pulmonary vein isolation combined with superior vena cava isolation for paroxysmal atrial fibrillation: a prospective randomized study.

Arch Cardiovasc Dis 2015 Mar 7;108(3):163-71. Epub 2015 Feb 7.

Division of Cardiology, Jean-Monnet University, Saint-Étienne, France.

Background: Radiofrequency ablation (RFA) of paroxysmal atrial fibrillation (PAF) has focused on pulmonary vein isolation (PVI). However, despite initial positive results, significant recurrences have occurred, partly because of pulmonary vein (PV) reconnection or non-PV ectopic foci, including the superior vena cava (SVC).

Objectives: This prospective, randomized study sought to investigate the efficacy of additional SVCI combined with PVI in symptomatic PAF patients referred for ablation.

Methods: From November 2011 to May 2013, RFA was performed remotely using a CARTO(®) 3 System in patients randomized to undergo PVI for symptomatic drug-refractory PAF, with (PVI+SVCI group) or without (PVI alone group) SVCI. PVI and SVCI were confirmed by spiral catheter recording during ablation. Procedural data, complications and freedom from atrial tachycardia (AT) and atrial fibrillation (AF) were assessed.

Results: Over an 18-month period, 100 consecutive patients (56±9years; 17 women) with symptomatic PAF were included in the study (PVI+SVCI, n=51; PVI, n=49); the CHA2DS2-VASc score was 0.9±1. Median duration of procedure (±interquartile), 2.5±1hours; total X-ray exposure, 13.3±8minutes; transseptal puncture and catheter positioning, 8±5minutes; left atrium electroanatomical reconstruction, 3±2minutes; and catheter ablation, 3.7±3minutes. After a median follow-up of 15±8months, and having undergone a single procedure, 84% of patients were symptom free, while 86% remained asymptomatic after undergoing two procedures. The cumulative risks of atrial arrhythmias (AT or AF) were interpreted using Kaplan-Meier curves and compared using the log-rank test. Long-term follow-up revealed no significant difference between groups, with atrial arrhythmias occurring in six (12%) patients in the PVI+SVCI group and nine (18%) patients in the PVI alone group (P=0.6). One transient phrenic nerve palsy and one phrenic nerve injury with partial recovery occurred in the PVI+SVCI group.

Conclusions: SVCI combined with PVI did not reduce the risk of subsequent AF recurrence, and was responsible for two phrenic nerve injuries. Accordingly, the benefit-to-risk ratio argues against systematic SVCI.
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http://dx.doi.org/10.1016/j.acvd.2014.10.005DOI Listing
March 2015

Does a patent foramen ovale matter when using a remote-controlled magnetic system for pulmonary vein isolation?

Arch Cardiovasc Dis 2014 Feb 18;107(2):88-95. Epub 2014 Feb 18.

Division of Cardiology, Jean-Monnet University, Saint-Étienne, France.

Background: Pulmonary vein isolation (PVI) takes longer when using a patent foramen ovale (PFO) compared with a transseptal puncture in paroxysmal atrial fibrillation (AF) with manual catheter ablation. To our knowledge, no data exist concerning the impact of a PFO on AF ablation procedure variables when using a remote magnetic navigation (RMN) system.

Aim: To assess the impact of a PFO when using an RMN system in patients requiring AF ablation.

Methods: Between December 2011 and December 2012, catheter ablation was performed remotely using the CARTO(®) 3 system in 167 consecutive patients who underwent PVI for symptomatic drug-refractory AF. The radiofrequency generator was set to a fixed power ≤ 35 W. The primary endpoint was wide-area circumferential PVI confirmed by spiral catheter recording during ablation for all patients and including additional lesion lines (left atrial roof) or complex fractionated atrial electrograms for persistent AF. Secondary endpoints included procedural data.

Results: Mean age 58±10 years; 18% women; 107 (64%) patients with symptomatic paroxysmal AF; 60 (36%) with persistent AF; CHA2DS2-VASc score 1.2 ± 1. The PFO presence was evidenced in 49/167 (29.3%) patients during the procedure but in only 26/167 (16%) by transoesophageal echocardiography. Median procedure time 2.5 ± 1 hours; median total X-ray exposure time 14 ± 7 minutes; transseptal puncture and catheter positioning time 7.5 ± 5 minutes; left atrium electroanatomical reconstruction time 3 ± 2.3 minutes; catheter ablation time 3 ± 3 minutes. No procedure time or X-ray exposure differences were observed between patients with or without a PFO during magnetic navigation catheter ablation. X-ray exposure time was significantly reduced using a PFO compared with double transseptal puncture access.

Conclusions: A PFO does not affect magnetic navigation during AF ablation; procedure times and X-ray exposure were similar. Septal catheter probing is mandatory to limit X-ray exposure and prevent potential complications.
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http://dx.doi.org/10.1016/j.acvd.2014.01.003DOI Listing
February 2014

Remote-controlled magnetic pulmonary vein isolation using a new three-dimensional non-fluoroscopic navigation system: a single-centre prospective study.

Arch Cardiovasc Dis 2013 Aug-Sep;106(8-9):423-32. Epub 2013 Jul 29.

Service de Cardiologie, Hôpital Nord, CHU de Saint-Étienne, Université Jean-Monnet, 42055 Saint-Étienne Cedex 2, France. Electronic address:

Background: Catheter ablation of atrial fibrillation (AF) focuses on pulmonary vein isolation (PVI), but the procedure is associated with significant X-ray exposure. Few data exist concerning the combination of remote magnetic navigation (RMN) and a new three-dimensional non-fluoroscopic navigation system (Carto(®) 3), which facilitates precise catheter navigation and limits X-ray exposure.

Aims: To assess the efficacy and extent of fluoroscopic exposure associated with the combination of RMN and the Carto 3 system in patients requiring AF ablation.

Methods: Between January and September 2011, catheter ablation was performed remotely using the Carto 3 system in 81 consecutive patients who underwent PVI for symptomatic drug-refractory AF. The radiofrequency generator was set to a fixed power ≤ 35W. The primary endpoint was wide-area circumferential PVI confirmed by spiral catheter recording during ablation and including additional lesion lines (left atrial roof and coronary sinus defragmentation) or complex fractionated atrial electrograms for persistent AF. Secondary endpoints included procedural data, complications and freedom from atrial tachycardia (AT)/AF.

Results: Mean age was 60 ± 9 years; 20% were women; 73% had symptomatic paroxysmal AF; 27% had persistent AF. The CHA2DS2-VASc score was 1.2 ± 1. Median procedure time was 3.5 ± 1 hours; median total X-ray exposure time was 13 ± 7 minutes; transseptal puncture and catheter positioning took 8 ± 4 minutes, left atrium electroanatomical reconstruction 1 ± 4 minutes and catheter ablation 3.5 ± 5minutes. Recurrences were AT (n=3; 3.7%), paroxysmal AF (n=8; 9.9%) and persistent AF (n=4; 4.9%); redo ablation was performed in these 15 (19%) patients. After a median follow-up of 15 ± 6 months and a single procedure, 71% of patients were free of symptoms; 84% remained asymptomatic after two procedures.

Conclusions: RMN with irrigated catheters combined with the Carto 3 system can be effectively performed in patients requiring AF ablation with minimal use of fluoroscopy, but larger randomized studies are warranted.
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http://dx.doi.org/10.1016/j.acvd.2013.04.008DOI Listing
June 2014

Focus on right ventricular outflow tract septal pacing.

Arch Cardiovasc Dis 2013 Jun-Jul;106(6-7):394-403. Epub 2013 Jul 10.

Service de Cardiologie, Université Jean Monnet, Hôpital Nord, Centre Hospitalier Universitaire de Saint-Etienne, France.

Experimental and clinical studies have shown that right ventricular apical pacing may result in long-term deleterious effects on account of its negative impact on left ventricular remodeling through desynchronization. This risk appears more pronounced in patients with even moderate left ventricular dysfunction and generally occurs after at least 1 year of pacing. As right ventricular apical pacing may be associated with the development of organic mitral insufficiency, other sites that allow for more physiological stimulation, such as right ventricular outflow tract septal pacing, have been developed, with good feasibility and reproducibility. However, the prospective randomized studies and meta-analyses to date have only demonstrated a modest effect on ejection fraction in the medium term, without any significant effect on quality of life and morbimortality. However, the absence of a favorable effect for right ventricular outflow tract septal pacing compared with right ventricular apical pacing in terms of clinical manifestations and patient prognosis appears to be more associated with the designs of these studies, which were not homogeneous with regard to methodology used, judgment criteria, follow-up and, especially, statistical power. Two randomized prospective multicentre studies are currently ongoing in order to evaluate the favorable effect of infundibular septal pacing, when considering the indirect negative effects of right ventricular apical pacing as reported in the literature.
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http://dx.doi.org/10.1016/j.acvd.2012.08.005DOI Listing
October 2013

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

Arch Cardiovasc Dis 2013 Mar 23;106(3):146-54. Epub 2013 Feb 23.

Division of Cardiology, University Jean-Monnet, Saint-Étienne, France.

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.
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http://dx.doi.org/10.1016/j.acvd.2012.12.002DOI Listing
March 2013

Remote magnetic navigation and arrhythmia ablation.

Arch Cardiovasc Dis 2012 Aug-Sep;105(8-9):446-53. Epub 2012 Jul 15.

Service de cardiologie, hôpital Nord, université Jean-Monnet, CHU de Saint-Étienne, 42055 Saint-Étienne cedex 2, France.

Radiofrequency treatment is the first-choice treatment for arrhythmias, in particular complex arrhythmias and especially atrial fibrillation, due to the greater benefit/risk ratio compared with antiarrhythmic drugs. However, complex arrhythmias such as atrial fibrillation require long procedures with additional risks such as X-ray exposure or serious complications including tamponade. Given this context, robotic magnetic navigation is a technique well suited to the treatment of complex arrhythmias, on account of its efficacy and reliability, the significant reduction in X-ray exposure for both patient and operator, and the very low risk of perforation. As ongoing developments will likely improve results and procedure times, this technology will become one of the most advanced for treating arrhythmias.
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http://dx.doi.org/10.1016/j.acvd.2012.02.009DOI Listing
February 2013

A single-centre experience concerning the safety of Sprint Fidelis defibrillator lead extraction at the time of pulse generator replacement or in case of evidence of lead failure.

Arch Cardiovasc Dis 2012 Apr 3;105(4):203-10. Epub 2012 Apr 3.

Division of Cardiology, Jean-Monnet University, 42000 Saint-Étienne, France.

Background: The reported failure rate of the Sprint Fidelis defibrillator lead (SFDL) has increased more than initially expected, with emerging evidence of accelerating fracture rates. Current consensus guidelines continue to discourage prophylactic lead extraction, citing major complication rates of 1.4-7.3%. Therefore, data relating to the risks of systematic SFDL extraction are lacking, with no methodical extraction protocol reported to date. Moreover, few statistical analyses have identified predictors of SFDL failure.

Objectives: The aims of this single-centre study were: to examine the safety and feasibility of systematic SFDL extraction at the time of pulse generator replacement or in case of lead failure; and to identify predictors of SFDL failure.

Methods: Between January 2005 and October 2007, 218 consecutive patients underwent transvenous SFDL implantation in our centre.

Results: During a mean follow-up of 43 ± 15 months, SFDL extraction was performed in 49 patients (22.5%) for the following reasons: inappropriate shocks (n = 21; 9.6%), systematic extraction at time of pulse generator extraction (n = 23; 10.5%), high impedance (n = 3; 1.4%), high SFDL threshold (n = 1; 0.4%) and cardiac device-related infection (n = 1; 0.4%). No severe complications occurred, although two minor complications were reported (lead dislodgments). SFDL fracture was observed in 25 patients (11.5%; 3.2%/year incidence). The only predictor associated with SFDL fracture was the number of leads (P = 0.01).

Conclusion: In our series, SFDL extraction at the time of pulse generator extraction or in case of evidence of lead failure was feasible and safe. Number of leads was identified as a new predictive factor for SFDL fracture.
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http://dx.doi.org/10.1016/j.acvd.2012.01.007DOI Listing
April 2012

Single-centre experience with an 8-mm tip catheter for radiofrequency catheter ablation of outflow tract ventricular ectopic beats.

Arch Cardiovasc Dis 2012 Jan 9;105(1):24-32. Epub 2012 Feb 9.

Department of Cardiology, Jean-Monnet University, Faculty of Medicine J.-Lisfranc, Service de cardiologie, hôpital Nord, CHU de Saint-Etienne, 42055 Saint-Étienne cedex 2, France.

Background: Radiofrequency ablation (RFA) of outflow tract ventricular ectopic beats (OTVEBs) can be performed using a 4-mm or externally-cooled tip RFA catheter, but no data are available concerning the safety and efficacy of a large-tip (8-mm) catheter.

Aims: To evaluate the feasibility of using an 8-mm tip catheter in patients with OTVEBs.

Methods: In this prospective cohort study, the 8-mm tip catheter was tested in patients who were referred to our centre for RFA of symptomatic OTVEBs.

Results: The mean age of the 16 patients recruited between September 2008 and March 2010 was 53±18 years and 56.3% were male. Mean left ventricular ejection fraction was 62±9%, mean ventricular ectopic beat width was 144±21 ms, and all patients had left bundle branch block. Fourteen patients had inferior axis QRS morphology and two had superior. The main symptoms were palpitations and pre-syncope. RFA parameters were: procedure time 94±35 min; duration of application 11±10 min; impedance 81±12 Ω; temperature 50±5 °C; and power 46±17 W. RFA succeeded in 15 over 16 patients (93.8%); and recurrence was seen in one patient after a mean follow-up time of 11±6 months. No complications were noted.

Conclusions: This preliminary study suggests that an 8-mm tip catheter may represent an alternative for RFA in patients with OTVEBs in whom a 4-mm tip was not successful. Larger randomized studies are therefore warranted.
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http://dx.doi.org/10.1016/j.acvd.2011.11.006DOI Listing
January 2012

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

Europace 2012 Jun 23;14(6):833-40. Epub 2011 Nov 23.

Division of Cardiology, Jean Monnet University, Saint-Etienne, France.

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.
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http://dx.doi.org/10.1093/europace/eur350DOI Listing
June 2012

Predictive factors of difficult implantation procedure in cardiac resynchronization therapy.

Europace 2010 Aug 23;12(8):1141-8. Epub 2010 Jun 23.

1Division of Cardiology, University Jean Monnet, Saint-Etienne, France.

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 operator's experience (very experienced operator vs. less experienced operator, P = 0.006). By multivariate analysis, only primary LV lead implantation failure, LVESD, and operator's 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 operator's experience were independent predictors of surgical difficulties. Left ventricular end-systolic volume was the only independent predictor of primary LV lead implant failure.
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http://dx.doi.org/10.1093/europace/euq146DOI Listing
August 2010

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

Eur Heart J 2010 Jan 28;31(2):203-10. Epub 2009 Oct 28.

Division of Cardiology, University Jean Monnet of Saint-Etienne, Saint-Etienne 42000, France.

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.
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http://dx.doi.org/10.1093/eurheartj/ehp421DOI Listing
January 2010

Radiofrequency catheter selection based on cavotricuspid angiography compared with a control group with an externally cooled-tip catheter: a randomized pilot study.

J Cardiovasc Electrophysiol 2009 May 21;20(5):492-8. Epub 2008 Nov 21.

The Jean Monnet University, Faculty of Medicine J. Lisfranc, Department of Cardiology, Saint-Etienne, France.

Background: Radiofrequency ablation (RFA) of cavotricuspid isthmus (CTI)-dependent atrial flutter (AFL) can be performed using either externally cooled-tip RFA catheters or large-tip (8 mm) catheters. However, experimental and clinical studies suggest that the efficacy of both catheters may vary with CTI anatomy and catheters orientation.

Objectives: The aim of this prospective study was to evaluate: a RFA catheter selection based on CTI angiography compared with a control group with an externally cooled-tip catheter together with the risk of an expensive crossover catheter in both groups.

Method: Over a period of 16 months, 119 patients were included and randomized.

Results: When comparing the angiographic group (n = 56) and the externally cooled-tip RFA catheter group (n = 63), the duration of application time with a median of 7 min (interquartile range 4.5-11) versus a median of 10 min (interquartile range 6-20; P = 0.008) and the duration of X-ray exposure with a median of 7 min (interquartile range 4-10) versus a median of 10 min (interquartile range 5-15; P = 0.025) were significantly lower in the angiographic group versus externally cooled-tip catheter group. Furthermore, the number of catheters crossover was significantly higher in the angiographic group versus externally cooled-tip catheter group I (27% vs 7%; P = 0.007).

Conclusions: This study shows that a strategy with a catheter selection based on a CTI angiographic evaluation is superior to an empirical use of an externally cooled-tip catheter during CTI RFA. Thus, angiographic isthmus evaluation predicts the effectiveness of a RFA catheter and the risk of an expensive catheter crossover.
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http://dx.doi.org/10.1111/j.1540-8167.2008.01367.xDOI Listing
May 2009

Catheter selection for ablation of the cavotricuspid isthmus for treatment of typical atrial flutter.

J Interv Card Electrophysiol 2006 Nov 1;17(2):93-101. Epub 2007 Mar 1.

Department of Cardiology, Faculty of Medicine J. Lisfranc, Jean Monnet University, Saint-Etienne Cedex 2, France.

Radiofrequency catheter ablation (RFA) represents the first line therapy of the cavotricuspid isthmus-dependent atrial flutter (CTI-AFL) with a high efficacy and low secondary effects. RFA of CTI-dependent AFL can be performed by using various types of ablation catheters. Recent evaluations comparing externally cooled tip RFA (ecRFA) catheters and large-tip (8 mm) catheters have revealed that these catheters have a higher efficacy for CTI-AFL ablation compared to 4-mm catheters. The reliability of RFA catheters for AFL is variable and an optimal catheter selection may enhance the RFA effectiveness. The main goal of this article is to review the elements that improve the management of CTI RFA. Preliminary examinations of histopathologic and anatomical elements that may interfere with conventional CTI RFA are presented. Experimental studies concerning the electrobiology of large-tip and cooled-tip catheters are compared. The different catheter designs between cooled-tip and 8-mm-tip catheters are examined (size of the deflectable curve, rotation stability, and size of the distal nonsteerable catheter part) because of their critical role in CTI RFA results. A thorough review of clinical trials of each catheter is presented, and comparison of both catheters in this clinical setting is analyzed. In addition, the role of CTI morphology on AFL RF duration is underlined such as the value of right atrial angiography as an adjunct tool for CTI RFA catheter selection. Based on randomized studies, 8-mm-tip catheters seem to be more effective for ablation in case of straight angiographic isthmus morphology. On the other hand, ecRFA catheters appear to be more effective in cases of complex CTI anatomy or difficult CTI RFA. To reduce X-ray exposition and RFA application time, few studies report that CTI angiographic evaluation before RFA allows a catheter selection based on both CTI morphology and length. Moreover, preliminary data of randomized studies showed that an angiographic isthmus evaluation may predict both the effectiveness of a RFA catheter and the risk of an expensive catheter crossover.
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http://dx.doi.org/10.1007/s10840-006-9064-yDOI Listing
November 2006

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.

Circulation 2006 Oct 9;114(16):1676-81. Epub 2006 Oct 9.

Division of Cardiology, University Jean Monnet in Saint-Etienne, Saint-Etienne, France.

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.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.106.638395DOI Listing
October 2006

Cavotricuspid isthmus angiography predicts atrial flutter ablation efficacy in 281 patients randomized between 8 mm- and externally irrigated-tip catheter.

Eur Heart J 2006 Aug 28;27(15):1833-40. Epub 2006 Jun 28.

Department of Cardiology, Faculty of Medicine J. Lisfranc, The Jean Monnet University, 42 055 Saint-Etienne, Cedex 2, France.

Aims: Radiofrequency ablation (RFA) of cavotricuspid isthmus (CTI)-dependent atrial flutter can be performed using various types of ablation catheters. Recent evaluations comparing externally cooled-tip RFA (ecRFA) catheters and large-tip (8 mm) catheters found that ecRFA catheter may have a higher efficacy for CTI ablation. The aim of this prospective study was to compare both catheters by stratifying on CTI morphology in order to explain, in part, the discrepancies between previous randomized studies, and to validate predictive factors of difficult CTI ablation on clinical, echocardiographic, and angiographic data.

Methods And Results: Over a period of 24 months, 281 patients were included and stratified on CTI morphology: 'straight', 'concave', and 'pouch-like recess'. In straight CTI (n=150), the duration of application time with a median of 6 min [interquartile range (IQR) 4-9] vs. a median of 12 min (IQR 16-19; P<0.0001) and the duration of X-ray exposure with a median of 6 min (IQR 4.4-9.7) vs. a median of 10.4 min (IQR 7-17; P<0.0001) were significantly lower with an 8 mm-tip when compared with ecRFA catheter. In contrast, in concave CTI (n=95), a trend towards both shorter application time with a median of 12.5 min (IQR 6-23) vs. a median of 19 min (IQR 7-28; P=0.08) and X-ray duration exposure with a median of 10.4 min (IQR 6-20) vs. a median of 13 min (IQR 8-24; P=0.08) with an ecRFA catheter when compared with 8 mm-tip catheter were evidenced. No significant difference was shown between 8 mm-tip and ecRFA catheters in the pouch-like recess group (n=36). Predictive factors of difficult ablation include right CTI length and morphology.

Conclusion: This study demonstrates that the 8 mm-tip catheter is more effective for ablation in case of a straight angiographic isthmus morphology and that the ecRFA catheter tends to be more effective in case of concave angiographic isthmus morphology. Thus, angiographic isthmus evaluation may predict both the effectiveness of an RF catheter, and the risk of an expensive crossover. These data may explain, in part, the discrepancies of previous studies comparing both catheters.
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http://dx.doi.org/10.1093/eurheartj/ehl121DOI Listing
August 2006

Long-term efficacy and safety of radiofrequency ablation in elderly patients with atrioventricular nodal re-entrant tachycardia.

Europace 2006 Jun 10;8(6):416-20. Epub 2006 May 10.

Division of Cardiology, University Jean Monnet of Saint-Etienne, France.

Aims: The purpose of this study was to evaluate the efficacy, risks, safety, and follow-up of radiofrequency (RF) catheter ablation of atrioventricular nodal re-entrant tachycardia (AVRNT) in patients (pts) > or = 75 years old (n=42) (GpI) compared with pts younger than 75 years (n=234) (GpII).

Methods And Results: The study population consisted of 276 consecutive pts (39.5% men/60.5% women), from 15 to 98-year-old (average 56+/-17 years) with AVRNT referred for RF ablation (RFA) from October 1997 to January 2004. Combined anatomical and electrogram approaches were used to guide RFA. The cumulative risk of AVRNT recurrence was analysed by the Kaplan-Meier method and log-rank test. The average follow-up was 34+/-18 months. GpI (80+/-4 years) differed significantly from GpII (51+/-14 years) regarding: heart rate tachycardia (160+/-20 vs. 180+/-30 bpm; P=0.0001), the slow pathway antegrade refractory period (370+/-70 vs. 340+/-60 ms; P=0.01), the fast pathway antegrade refractory period (360+/-60 vs. 330+/-60 ms; P=0.003), retrograde refractory period (360+/-60 vs. 330+/-60 ms; P=0.0007), left ventricular ejection fraction (60+/-12 vs. 65+/-7%; P=0.0009), and ischaemic ECG signs during tachycardia (76.2% vs. 61%; P=0.09). RFA was successfully obtained in 275/276 (99.6%), 42/42 in GpI (100%), and 233/234 (99.6%) in GpII. Five complications occurred (1.8%): major complications in two pts (0.7%) and minor complications in three pts (1.1%). Major complications were deep venous thrombosis with pulmonary embolus (n=1) and pericardial effusion (n=1), minor complications were groin haematoma (n=3). One complication was observed in GpI (groin haematoma) (2.4%) and four in GpII (deep venous thrombosis with pulmonary embolus in one, groin haematoma in two, and pericardial effusion in one) (1.7%). The number of recurrences was not statistically different between the two groups (0 vs. 3.4%; P=0.5) with a respective average follow-up of 28+/-18 and 35+/-18 months, respectively.

Conclusion: Catheter ablation of AVRNT in elderly and very elderly pts appears to be a reasonable approach regarding feasibility and effectiveness without increasing the risk of AV block.
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http://dx.doi.org/10.1093/europace/eul033DOI Listing
June 2006

Prospective validation of stress echocardiography as an identifier of cardiac resynchronization therapy responders.

Heart Rhythm 2006 Apr;3(4):406-13

Division of Cardiology, University Jean Monnet of Saint-Etienne, Saint-Etienne, France.

Background: Cardiac resynchronization therapy (CRT) provides benefit for congestive heart failure (CHF), but predictors of the clinical response are debated.

Objective: The aim of this prospective study was to assess the predictive role of dobutamine stress echocardiography (DSE) in identifying a suitable candidate for CRT.

Methods: From March 2001 to December 2003, 71 CHF patients were prospectively enrolled on the basis of four criteria: New York Heart Association (NYHA) class III and IV; QRS > or =150 ms with a left bundle branch block pattern, and left ventricular ejection fraction (LVEF) < or =35% under optimal medical treatment. The combined endpoints were hospital readmission for class IV CHF, heart transplant (HT), and CHF-related death.

Results: The 67 patients completing the study presented with the following characteristics: age (70 +/- 10 years; 11 women); etiology (idiopathic in 44, ischemic in 23); NYHA class (40 in class III and 27 in class IV); LVEF 26% (+/-5%); QRS duration (190 +/- 28 ms); 6-minute walk test 330 m (+/-108); peak oxygen uptake 10.7 (+/-3.3 mL/kg/min); mitral insufficiency in 42 (> or =III grade); interventricular (IV) delay (62 +/- 21 ms); and intraventricular dyssynchrony in 30 patients. Over the follow-up period of 12.1 +/- 8.7 months, 20 (29.9%) of 67 patients presented with at least one hemodynamic event: hospitalization for CHF in 19 (28%) of 67, HT in 2 (3%) of 67, and CHF death in 7 (10%) 67. Univariate analysis identified NYHA class (P = .03), LVEF (P = .015), IV dyssynchrony before (P = .038) and after CRT (P = .0035), IV delay after CRT (P = .002), 6-minute walk distance (P = .01), and DSE Res+ (P = .008) as significant predictors of clinical events. A receiver operating curve established a cut-off value of 1.25 for the DSE responders (Res+: 34 patients at 10 microg/kg/min infusion rates), and the improvement at the 10 microg/kg/min level was 41% +/- 7% in Res+ and 29% +/- 8% in nonresponders (P<.0001). With a cut-off value of 1.25-fold the LVEF increase, the DSE test exhibits 70% sensitivity, 61.7% specificity, 43.8% positive predictive value, and 82.9% negative predictive value. Cox analysis identified IV dyssynchrony before CRT (P = .01) and DSE Res+ (P = .003) as independent predictive factors.

Conclusions: Independent predictive factors of severe hemodynamic clinical outcome in patients with CRT are IV dyssynchrony and DSE.
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http://dx.doi.org/10.1016/j.hrthm.2005.12.017DOI Listing
April 2006

Comparison of the efficacy of cooled-tip and 8-mm-tip catheters for radiofrequency catheter ablation of the cavotricuspid isthmus: a meta-analysis.

Pacing Clin Electrophysiol 2005 Oct;28(10):1081-7

Division of Cardiology, University Jean Monnet of Saint-Etienne, France.

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.

Methods: Reports of trials were identified through a Medline, Embase, Current Contents, Cardline, and an extensive bibliography search. Trials that met the following criteria were included: (1) prospective, randomized, controlled, and open trials; (2) patients assigned to an 8-mm-tip or a cRFA catheter for AFL RFA; (3) endpoints events related to primary success rate (BIB achievement), and procedure parameters (number of RF applications, x-ray exposure and ablation duration).

Results: Seven trials met the inclusion criteria. They included 603 patients with established AFL randomized to an 8-mm-tip or cRFA catheter group. Comparing 8-mm groups with cRFA groups, the meta-analysis showed similar BIB achievement relative risk (RR) 0.96, 95% confidence interval (CI): 0.92 to 1.01, (P = 0.13); total RF application time weighted mean difference (WMD) 0.88, 95% CI: -0.36 to 2.12, (P = 0.16); duration of x-ray exposure (min) (WMD = 1.07, 95% CI: -0.81 to 0.295, (P = 0.26); ablation procedure duration (min) (WMD = 0.68, 95% CI: -3.37 to 4.73; P = 0.74).

Conclusion: The present meta-analysis confirms that cooled-tip and large-tip catheters are equally efficient for cavotricuspid isthmus ablation with both similar primary success rates and procedure parameters.
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http://dx.doi.org/10.1111/j.1540-8159.2005.00231.xDOI Listing
October 2005

Simplified cardiac resynchronization implantation technique involving right access and a triple-guide/single introducer approach.

Heart Rhythm 2005 Jul;2(7):714-9

Division of Cardiology, University Jean Monnet of Saint-Etienne, 42055 Saint-Etienne, France.

Background: Biventricular pacing is useful for patients with congestive heart failure but has the disadvantage of being a long, user-dependent, highly technical procedure.

Objectives: The purpose of this study was to simplify the procedure. The simplified technique consists of sinus (CS) venography prior to implantation, direct coronary access for the left ventricular (LV) lead without use of a left-heart delivery system, and triple-guide/one introducer cephalic vein access as the first approach in patients presenting in sinus rhythm.

Methods: A cephalic cutdown was performed, and a steerable hydrophilic guidewire was introduced in the cephalic vein. A 9Fr introducer was advanced over the guidewire, and two other guides were inserted through the introducer. This technique allowed for insertion of a right ventricular lead, an LV lead, and an atrial lead.

Results: One hundred three patients were evaluated from January 2002 to September 2004. Four implants failed (3.9%). The 7Fr LV lead was successfully placed in 99 of 103 patients (96.1%) directly via the 9Fr introducer, without use of a dedicated left-heart delivery system. The final position was lateral in 59 patients, posterolateral in 33, posterior in 4, and anterolateral in 3. Sixty patients were in sinus rhythm, 13 were in atrial fibrillation, and 26 had a previous pacemaker (n = 21) or defibrillator (n = 5). Triple cephalic vein access was possible in 48 of the patients in sinus rhythm (80%). Procedure parameters were as follows: LV threshold 0.9 +/- 0.7 V, LV wave amplitude 15 +/- 8 mV, LV impedance 790 +/- 232 Omega, skin-to-skin procedure time 76 +/- 33 minutes, and fluoroscopy time 23 +/- 19 minutes. Ten complications (10.1%) occurred: 7 lead dislodgments (3 within 48 hours and 4 within 6 months) requiring repositioning (7.1%), 1 subacute local infection requiring explantation (1%), 1 phrenic nerve stimulation (1%), and 1 pneumothorax (1%). The long-term success of biventricular pacing was 93.1%.

Conclusions: This study demonstrates that cardiac resynchronization therapy implantation can be simplified with the combined use of a steerable hydrophilic guidewire, three guides, and one introducer via a right cephalic vein, without use of a left-heart delivery system. The triple cephalic vein approach yields an 80% implant success rate for patients in sinus rhythm. The long-term success of biventricular pacing was 93.1%.
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http://dx.doi.org/10.1016/j.hrthm.2005.04.005DOI Listing
July 2005

Clinical predictors of cardiac events in patients with isolated syncope and negative electrophysiologic study.

Int J Cardiol 2006 Apr 21;109(1):28-33. Epub 2005 Jun 21.

Division of Cardiology, University Jean Monnet of Saint-Etienne, 42000 Saint-Etienne, France.

Background: Patients with syncope or near syncope of unknown etiology represent a great challenge to cardiologists. An initial symptomatic episode triggers a series of diagnostic analysis which remain unsatisfactory when negative. More invasive tools such as electrophysiologic testing yield only partial answers to risk stratification while the complementary implantable holter diagnostics are not usually considered until a recurrent episode is documented.

Objective: This study targets predictors of significant cardiac rhythmic events in patients with a reported episode of syncope or near syncope presenting with negative diagnostics and electrophysiologic study results (EPS). A significant cardiac rhythmic event was defined as a combined end-point of (1) symptomatic AV block; (2) symptomatic conduction abnormalities requiring pacemaker therapy; (3) symptomatic sustained ventricular arrhythmia; and (4) sudden death.

Methods: All patients undergoing EPS after a first episode of syncope or presyncope between January 1997 and December 2001 were included for analysis. The study population consisted of 329 pts (42.6% women), 21 to 96 years old (mean 70+/-15 years) referred for an EP study for syncope or near syncope.

Results: Of the 329 patients who underwent EPS, 305 (92.7%) had follow-up data. The population, mean age 70 (+/- 15 years) and composed of 42% women, presented with hypertension (51.5%), diabetes mellitus (14.4%), hypercholesterolemia (30%), tobacco use (35%), a familial history of coronary heart disease (22%), history of stroke (4%), history of MI (12%), history of atrial fibrillation (10%), structural heart disease (17.4%), left ventricular ejection fraction 61 (+/- 11%) and ECG abnormalities (37%). These anomalies included right (RBBB) or left (LBBB) bundle branch blocks, left anterior fascicular block (LAFB), left posterior fascicular block (LPFB), bifascicular block (RBBB+LAFB) and traces of myocardial infarction. The mean follow-up was 31+/-20 months with 5% of patients recording significant cardiac rhythmic events (15/305): AV block requiring pacemaker therapy in 7 patients, sinus dysfunction in 4, sudden death in 3 and ventricular tachycardia in 1. Univariate analysis reveals structural heart disease, ECG abnormalities and LVEF associated with the risk of significant cardiac rhythmic events defined by the combined end-point. Multivariate analysis using a Cox model found that the only independent predictor of events was an ECG abnormality. The long-term risk of significant event in the subset with ECG abnormalities is of 10.6% (12/113). If unexplained syncope recurrence was included in the combined end-point, ECG abnormality and LVEF were both determinants with a 13.3% (15/113) risk of a arrhythmic events analysis in the subset of patients presenting with ECG abnormalities and Cox model found ECG abnormality as the only independent predictor of event.

Conclusions: This study demonstrated that an ECG abnormality is the only predictive variable associated with a significant arrhythmic event in patients with a lone episode of syncope or near syncope and a negative EPS.
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http://dx.doi.org/10.1016/j.ijcard.2005.05.025DOI Listing
April 2006

Anatomic and electrophysiological differences between chronic and paroxysmal forms of common atrial flutter and comparison with controls:.

Pacing Clin Electrophysiol 2004 Sep;27(9):1202-11

Division of Cardiology, University Jean Monnet of Saint-Etienne, Saint-Etienne, France.

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 cm2; P < 0.0001 and 23 +/- 5 vs 16 +/- 3 cm2, P < 0.0001), LV end-systolic and end-diastolic volumes (50 +/- 25 vs 32 +/- 13 cm3, P = 0.0084 and 112 +/- 40 vs 85 +/- 25 cm3, 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.
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http://dx.doi.org/10.1111/j.1540-8159.2004.00610.xDOI Listing
September 2004