Publications by authors named "Karl Isaaz"

68 Publications

Predictors of high-degree conduction disturbances and pacemaker implantation after transcatheter aortic valve replacement: Prognostic role of the electrophysiological study.

Authors:
Thomas Ferreira Antoine Da Costa Alexis Cerisier Nicolas Vidal Jean Baptiste Guichard Cécile Romeyer Jean Claude Barthelemy Karl Isaaz

Pacing Clin Electrophysiol 2021 Mar 19. Epub 2021 Mar 19.

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

Background: Predictors of high-degree atrioventricular block (HAVB) after transcatheter aortic valve replacement (TAVR) are recognized, but the electrophysiological study's (EPS) role is still a subject to debate. The objective of our study was to determine factors associated with PPM implantation including the potential role of EPS before and/or after TAVR.

Methods And Results: Seventy four consecutive patients (pts) were included and 21 pts (28.4%) received a PPM during the immediate postoperative follow-ups (until Day 5): HAVB in 15 pts (71.4%), prophylactic implantation due to a documented increased HV interval ≥ 95-100 ms plus LBBB in 2 pts (9.5%), a high-degree HV block evidenced at the EPS plus LBBB in 3 pts (14.3%) and one additional patient was implanted for AV-block in presence of AFib (4.8%). In the multivariate model 1 including parameters before TAVR, both prosthesis diameter and PR lengthening remained significantly associated with PPM as well RBBB. In the multivariate model 2 including parameters after TAVR, only HV remained significantly associated with the risk of PPM (OR = 1.15 (1.05-1.26), p = .004). When all the significant variables in models 1 and 2 were analyzed together in model 3, only HV after TAVR remained significantly associated with an increased risk of PPM.

Conclusions: In this prospective observational study, it was revealed that a Day 4-5 EPS is likely to more precisely stratify the risk of PPM implantation regarding its ability to discover asymptomatic severe infra-hisian conduction disturbances particularly in presence of LBBB. Multivariate analysis confirmed the prognostic value of HV alteration.
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http://dx.doi.org/10.1111/pace.14225DOI Listing
March 2021

Radiation Exposure for Percutaneous Interventions of Chronic Total Coronary Occlusions in a Multicenter Registry: The Influence of Operator Variability and Technical Set-up.

Authors:
Gerald S Werner Alexandre Avran Kambis Mashayekhi Joerg Reifart Alfredo R Galassi Nicolas Boudou Markus Meyer-Gessner Roberto Garbo Joachim H Buettner Alexander Bufe James C Spratt Leszek Bryniarski Artis Kalnins Aigars Lismanis Evald H Christiansen Victoria Martin-Yuste Karl Isaaz Georgios Sianos Andrea Gagnor Carlo di Mario David Hildick-Smith Antonio Serra Luca Grancini Nicolaus Reifart

J Invasive Cardiol 2021 Mar 11;33(3):E146-E154. Epub 2021 Feb 11.

Medizinische Klinik I, Klinikum Darmstadt GmbH, Grafenstrasse 9, D-64283 Darmstadt, Germany.

Aims: Radiation exposure is a limiting factor for percutaneous coronary interventions (PCI) of chronic total coronary occlusion (CTO) lesions. This study was designed to analyze changes in patient radiation dose for CTO-PCI and parameters associated with radiation dose.

Methods And Results: We analyzed a cohort of 12,136 procedures performed by 23 operators between 2012 and 2017 from the European Registry of CTO-PCI. Radiation exposure was recorded as air kerma (AK) and dose area product (DAP). A dose rate index (DRI) was calculated as AK per fluoroscopy time to normalize for individual differences in fluoroscopy time. The lesion complexity increased from Japanese-CTO (J-CTO) score of 2.19 ± 1.44 to 2.46 ± 1.28, with an increase of retrograde procedures from 31.1% to 40.7%; still, procedural success improved from 87.7% to 92.1%. Fluoroscopy time remained similar, but AK decreased by 14.9%, from 2.35 Gy (interquartile range [IQR], 1.29-4.14 Gy) to 2.00 Gy (IQR, 1.08-3.45 Gy) and DAP decreased by 21.5%, from 130 Gy•cm² (IQR, 70-241 Gy•cm²) to 102 Gy•cm² (IQR, 58-184 Gy•cm²). Radiation exposure was determined by the lesion complexity (J-CTO score) and procedural complexity (antegrade or retrograde). DRI was determined by fluoroscopy frame rate and type of equipment used, but the major influence remained interoperator differences.

Conclusions: Radiation exposure decreased during the observation period despite an increase in lesion and procedural complexity. While many operators already achieved a goal of low radiation exposure, there were considerable interoperator differences in radiation management, indicating further potential for improvement.
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March 2021

Impact of β-blocker therapy on right ventricular function in heart failure patients with reduced ejection fraction. A prospective evaluation.

Authors:
Rémi Galves Antoine Da Costa Romain Pierrard Geoffrey Bayard Jean Baptiste Guichard Karl Isaaz

Echocardiography 2020 09 20;37(9):1392-1398. Epub 2020 Aug 20.

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

Background: Beta-blocker (β-blocker) therapy 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 β-blockers are well described, their effects on right ventricular (RV) function have not been prospectively studied.

Objective: This prospective study aimed to (a) evaluate whether β-blocker therapy impacts RV remodeling based on echo parameters and (b) determine the predictive echo factors of β-blocker therapy response.

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

Results: Overall, 40 patients (pts) completed the study, characterized as follows by age: 70 ± 10 years; gender: 10 women; cardiomyopathy etiology: idiopathic in 24 and ischemic in 16; NYHA Class: II in 22 and III in 10; LVEF: 32 ± 5%; and NTProBNP: 2665 ± 2400 pg/mL. The final population comprised 32 pts (79%), with eight (21%) excluded: two because of β-blocker therapy intolerance, one lost to follow-up, and five withdrew from the study. Under β-blocker therapy, several echo parameters significantly improved: LVEF from 31.7 ± 9 to 40.5 ± 9 (P < .0001); LV end-diastolic volume (EDV) from 154 ± 54 to 143 ± 45 mL (P = .06); LV end-systolic volume (ESV) from 107 ± 49 to 88 ± 37 mL (P = .0006); LV ES from 46 ± 11 to 64 ± 13 mL (P = .008); LV end-diastolic diameter (EDD) from 57 ± 9 to 54 ± 6 mm (P = .04); LV end-systolic diameter (ESD) from 48 ± 10 to 44 ± 7 mm (P = .007); and right ventricular systolic pressure (RV SP) from 39 ± 10 to 32 ± 8 mm Hg (P = .0001). Significant modifications were observed in terms of RV echo parameters: right ventricular (RV) size decreased from 30 ± 4 to 27 ± 5 mm (P = .03), while RV systolic function significantly improved based on tricuspid annular plane systolic excursion (TAPSE) (16.5 ± 4 vs. 19 ± 4 mm; 0.0006); DTI-derived tricuspid lateral annular systolic velocity wave (S') (10 ± 2 vs. 11.3 ± 3 cm/s; P = .03); and RIMP (Tei index) (0.5 ± 0.1 vs 0.46 ± 0.1; P = .04). RV 2D fractional area change (%) did not significantly differ despite a clear improvement tendency (35 ± 6 vs. 37 ± 4%; P = .1). No significant modifications were observed concerning LV diastolic parameters. Overall, β-blocker echo responders (n = 23/32; 72%) exhibited the same left and right echo parameters. No echo variables predicted the β-blocker response.

Conclusions: In HFrEF pts, β-blocker therapy significantly improves LV and RV systolic remodeling. Accordingly, β-blocker therapy could be applied as soon as possible in HFrEF patients with right ventricular dysfunction so as to limit RV remodeling.
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http://dx.doi.org/10.1111/echo.14813DOI Listing
September 2020

MRI of Reperfused Acute Myocardial Infarction Edema: ADC Quantification versus T1 and T2 Mapping.

Authors:
Kevin Moulin Magalie Viallon William Romero Alban Chazot Nathan Mewton Karl Isaaz Pierre Croisille

Radiology 2020 Jun 24;295(3):542-549. Epub 2020 Mar 24.

From the Univ Lyon, UJM-Saint-Etienne, INSA, CNRS UMR 5520, INSERM U1206, CREATIS, Saint-Etienne, France (K.M., M.V., W.R., A.C., P.C.); Department of Radiology, Centre Hospitalier Universitaire de Saint Etienne, CREATIS UMR 5020, INSERM U1206, Avenue Albert Raimond, 42000 Saint Etienne Cedex, France (M.V., P.C.); Hôpital Cardiologique Louis Pradel, Centre d'Investigation Clinique, INSERM 1407, Lyon, France (N.M.); and Department of Cardiology, University Hospital Saint Etienne, Université Jean Monnet, Saint Etienne, France (K.I.).

Background After acute myocardial infarction (AMI), reperfusion injury is associated with microvascular lesions and myocardial edema. Purpose To evaluate the performance of apparent diffusion coefficient (ADC) quantification compared with T1 and T2 values in the detection of acute myocardial injury. Materials and Methods In this prospective study conducted from June 2016 to November 2018, participants without a history of heart failure or cardiomyopathy were enrolled after undergoing reperfusion for their first AMI. Quantitative T1 and T2 mapping were performed with a 1.5-T MRI scanner and compared with a fast free-breathing acquisition technique for ADC mapping (approximate duration, 3 minutes; five slices; spin-echo cardiac diffusion acquisition; values, 0 and 200 sec/mm; six diffusion-encoding directions; five repetitions). Quantitative ADC and unenhanced T1 and T2 values were compared in infarct, border, and remote regions by using Welch analysis of variance with Games-Howell post hoc test for pairwise comparisons. Results Thirty-four participants with AMI underwent MRI an average of 5 days ± 1.9 (standard deviation) after reperfusion. Mean ADC was markedly high in the infarcted regions (2.32 × 10 mm/sec; 95% confidence interval [CI]: 2.28, 2.36) and moderately high in the border regions (1.91 ×10 mm/sec; 95% CI: 1.89, 1.94; < .001). In remote regions, mean ADC (1.62 ×10 mm/sec; 95% CI: 1.59, 1.64) was comparable to that measured in vivo in healthy volunteers. Within the same regions of interest, although the measures showed similar trends in infarct and remote regions for T1 (mean, 1332 mec [95% CI: 1296, 1368] vs 1045 msec [95% CI: 1034, 1056]; < .001) and T2 (72 msec [95% CI: 69, 75] vs 50 msec [95% CI: 49, 51]; < .001), the magnitude of the differences among regions was greater when using ADC. Normalized signal differences between infarct and remote regions showed that diffusion-weighted MRI depicted edema 5.1 ( < .001) and 3.5 ( < .001) times greater than did T1 and T2 maps, respectively. Conclusion Multislice cardiac diffusion-weighted images could be acquired in those with acute myocardial injury. Quantitative apparent diffusion coefficient mapping showed greater differences among remote regions and lesions than did T1 or T2 mapping. © RSNA, 2020 See also the editorial by Lloyd and Farris in this issue.
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http://dx.doi.org/10.1148/radiol.2020192186DOI Listing
June 2020

Management of Left Ventricular Thrombi with Direct Oral Anticoagulants: Retrospective Comparative Study with Vitamin K Antagonists.

Authors:
Jessica Daher Antoine Da Costa Christophe Hilaire Thomas Ferreira Romain Pierrard Jean Baptiste Guichard Cécile Romeyer Karl Isaaz

Clin Drug Investig 2020 Apr;40(4):343-353

Division of Cardiology, Jean Monnet University, Saint-Etienne Cedex 2, Loire, France.

Background And Objectives: The efficacy of direct oral anticoagulants (DOACs) in the management of left ventricular (LV) thrombi remains to be determined, especially in patients with ischemic cardiomyopathy. This retrospective study sought to compare the efficacy of vitamin K antagonists (VKAs) and DOACs in patients with LV thrombi and evaluate the rate of LV thrombus resolution after adjusting anticoagulation.

Methods: This observational retrospective study included patients admitted to our institution for LV thrombus between January 2010 and August 2019. The rate of LV thrombus resolution was compared between VKAs and DOACs. Patients without thrombus resolution with DOAC treatment were switched to VKA agents in order to obtain an international normalized ratio (INR) of 3-4.

Results: Between January 2010 and August 2019, 59 consecutive patients with LV thrombi detected by transthoracic echocardiography were included in the study. The mean age was 62 ± 14 years and 16.9% were women. The circumstances of LV thrombus discovery were as follows: acute myocardial infarction or ischemic myocardiopathy (n = 22), stroke (n = 6), chest pain (n = 7), heart failure (n = 11), transthoracic echocardiographic evaluation (n = 11), and ventricular arrhythmias (n = 2). The proportion of patients on DOACs was 28.8% (n = 17), while that of those on VKAs was 71.2% (n = 42). Thrombus resolution was obtained in 70.6% (12/17) of patients on DOACs and in 71.4% (30/42) of those on VKAs (p = 0.9). Patients who failed to respond to DOAC treatment were treated with VKAs, and following this treatment adjustment all LV thrombi were dissolved in the DOAC group (5/5). Five embolic events (8.4% of stroke) occurred before the treatment initiation and six with anticoagulants (2/17 with DOACs [11.8%] and 4/42 with VKAs [9.5%]; p = 0.8).

Conclusions: This retrospective observational study found a similar efficacy between DOAC and VKA agents in patients with LV thrombi (70.6% vs. 71.5%); however, when the thrombus remains, VKAs are still the standard of care as it is possible to control INR levels (3-4) with them.
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http://dx.doi.org/10.1007/s40261-020-00898-3DOI Listing
April 2020

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

Authors:
Geoffrey Bayard Antoine Da Costa Romain Pierrard Cécile Roméyer-Bouchard Jean Baptiste Guichard Karl Isaaz

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

Pre-participation cardiovascular evaluation in Pacific Island athletes.

Authors:
Jean-Claude Chatard Florian Espinosa Richard Donnadieu Jean-Paul Grangeon Jean-Marie Sabot Christian Guivarch Régis Dacquin François-Xavier Raby Gérard Papouin Satu Viali Corinne Braunstein Antoine Gerbay Frédéric Roche Karl Isaaz Jean-Claude Barthélémy François Carré

Int J Cardiol 2019 Mar 16;278:273-279. Epub 2018 Nov 16.

CHU Pontchaillou, University of Rennes 1, INSERM U1099, France.

Background: Pre-participation cardiovascular evaluation (PPE) aims to detect cardiac disease with sudden cardiac death (SCD) risk. No study has focused on Pacific Island athletes.

Methods: A total of 2281 Pacific Island athletes were studied with (i) a questionnaire on family, personal history and symptoms, (ii) a physical examination and (iii) a 12-lead ECG.

Results: 85% presented a normal history and examination. A positive family history was 1.4-1.9 fold higher in Melanesians, Polynesians and Métis than in Caucasians, while a positive personal history, abnormal symptoms and abnormal examination was 1.3 fold higher in Melanesians and Métis than in others. Neither gender nor training level had a bearing on these results. Melanesians had higher T wave inversions (TWIs) in V2-V4 leads but had no CV abnormalities. Lateral or infero-lateral TWIs were found in 6 male and in 5 highly trained athletes and cardiomyopathies were diagnosed in 3/6 athletes. Overall, 3.9% athletes were found to have a CV abnormality and 0.8% had a risk of SCD. Polynesians and males were more at risk than the others while the level of training made no difference. In athletes at risk of SCD, the main detected CV diseases were cardiomyopathies, Wolff-Parkinson-White (WPW) and severe valve lesions of rheumatoid origin.

Conclusions: PPE revealed that 3.9% presented CV abnormalities. A risk of SCD was found in 0.8% with cardiomyopathies, WPW, and severe valve lesions of rheumatoid origin. Melanesians, Polynesians and male of high level of training were more at risk than others.
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http://dx.doi.org/10.1016/j.ijcard.2018.11.012DOI Listing
March 2019

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

Authors:
Antoine Da Costa Clarisse Delolme Jean Baptiste Guichard Antoine Gerbay Romain Pierrard Cécile Romeyer-Bouchard Karl Isaaz

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

Bioresorbable vascular scaffold in chronic total occlusions.

Authors:
Antoine Gerbay Karl Isaaz

EuroIntervention 2017 09;13(7):885-886

Department of Cardiology, University of Saint Etienne, Saint Etienne, France.

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http://dx.doi.org/10.4244/EIJ-D-17-00364LDOI Listing
September 2017

Temporal Trends in Transcatheter Aortic Valve Replacement in France: FRANCE 2 to FRANCE TAVI.

Authors:
Vincent Auffret Thierry Lefevre Eric Van Belle Hélène Eltchaninoff Bernard Iung René Koning Pascal Motreff Pascal Leprince Jean Philippe Verhoye Thibaut Manigold Geraud Souteyrand Dominique Boulmier Patrick Joly Frédéric Pinaud Dominique Himbert Jean Philippe Collet Gilles Rioufol Said Ghostine Olivier Bar Alain Dibie Didier Champagnac Lionel Leroux Frédéric Collet Emmanuel Teiger Olivier Darremont Thierry Folliguet Florence Leclercq Thibault Lhermusier Patrick Olhmann Bruno Huret Luc Lorgis Laurent Drogoul Bernard Bertrand Christian Spaulding Laurent Quilliet Thomas Cuisset Maxence Delomez Farzin Beygui Jean-Philippe Claudel Alain Hepp Arnaud Jegou Antoine Gommeaux Anfani Mirode Luc Christiaens Charles Christophe Claude Cassat Damien Metz Lionel Mangin Karl Isaaz Laurent Jacquemin Philippe Guyon Christophe Pouillot Serge Makowski Vincent Bataille Josep Rodés-Cabau Martine Gilard Hervé Le Breton

J Am Coll Cardiol 2017 Jul;70(1):42-55

Cardiology and Vascular Diseases Service, Pontchaillou University Hospital Center, Center for Clinical Investigation 804, University of Rennes 1, Signal and Image Treatment Laboratory (LTSI), National Institute of Health and Medical Research U1099, Rennes, France. Electronic address:

Background: Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics and clinical outcomes over time are limited.

Objectives: The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period.

Methods: TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers.

Results: A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE]: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium-defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p < 0.001 for both). Stroke and potentially life-threatening complications, such as annulus rupture or aortic dissection, remained stable over time, whereas rates of cardiac tamponade and pacemaker implantation significantly increased.

Conclusions: The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter [FRANCE TAVI]; NCT01777828).
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http://dx.doi.org/10.1016/j.jacc.2017.04.053DOI Listing
July 2017

Impact of very high pressure stent deployment on angiographic and long-term clinical outcomes in true coronary bifurcation lesions treated by the mini-crush stent technique: A single center experience.

Authors:
Antoine Gerbay Jeremy Terreaux Alexis Cerisier Marco Vola Karl Isaaz

Indian Heart J 2017 Jan - Feb;69(1):32-36. Epub 2016 Jun 1.

Division of Cardiology, University of Saint Etienne, Saint Etienne, France.

Background: Percutaneous coronary intervention (PCI) for bifurcation lesions (BL) using 2 stents technique is known to be associated with high rates of procedural failure especially on the side branch (SB) mainly due to stent incomplete apposition. Stent deployment at very high pressure (SDHP) may lead to better stent expansion and apposition. However, SDHP may also be at the origin of deeper wall injury resulting into major cardiac adverse events. No data are available on evaluation of SDHP in BL treated by a mini-crush stent technique.

Methods: One hundred and thirteen consecutive patients underwent PCI for BL (Medina 1, 1, 1) using a mini-crush stent technique with SDHP defined as ≥20atm. An angiographic follow-up was performed at 6 month and clinical follow-up was obtained at a median of 3 years.

Results: Stent deployment mean pressures were 20±1.4atm (range 20-25) in the main vessel (MV) and 20±1.5atm (range 20-25) in SB. Simultaneous final kissing balloon was used in 92% of cases. PCI was successful in 100%. Angiographic follow-up was obtained in 83% of patients. Restenosis rate was 13% (12% restenosis in the SB) with only one case (0.8%) of SB probable thrombosis. Another case of late stent thrombosis occurred at a 3 years clinical follow-up.

Conclusion: Compared with previously published studies in which stents were deployed at lower pressure, SDHP does not increase the restenosis rate in BL using mini-crush stent technique but seems to reduce the rate of stent thrombosis.
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http://dx.doi.org/10.1016/j.ihj.2016.05.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5318982PMC
October 2017

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

Authors:
Antoine Da Costa Jean Baptiste Guichard Nicolas Maillard Cécile Romeyer-Bouchard Antoine Gerbay Karl Isaaz

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.

Authors:
Antoine Da Costa Amandine Axiotis Cécile Romeyer-Bouchard Loucif Abdellaoui Zahi Afif Jean Baptiste Guichard Antoine Gerbay Karl Isaaz

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

Sutureless aortic bioprosthesis valve implantation and bicuspid valve anatomy: an unsolved dilemma?

Authors:
Marco Vola Jean-Baptiste Guichard Salvatore Campisi Jean-François Fuzellier Antoine Gerbay Fabien Doguet Karl Isaaz Kasra Azarnoush Amedeo Anselmi Vito Giovani Ruggieri

Heart Vessels 2016 Nov 12;31(11):1783-1789. Epub 2016 Jan 12.

Cardiac Surgery Unit, Cardiovascular Department, University Hospital, St. Etienne, France.

Interest is growing in the clinical use of sutureless (SU) valves. However, indications in some anatomical sub-settings, like bicuspid aortic valves (BAV), have been so far limited. We discuss herein our initial experience with the implantation of the 3f Enable SU bioprosthesis in patients with a BAV. Patients with a BAV were selected in our unit between March 2011 and September 2014 for a SU 3f Enable valve implantation. Twenty of the 198 patients who underwent a 3f Enable valve implantation in our unit had a BAV. Procedural success was 100 %, but reclamping was necessary in one (5 %) case. Median size of implanted bioprosthesis was 23 mm. After a mean follow-up of 13.8 ± 10.7 months, survival was 100 %. Two patients (10 %) showed an immediate grade 1 paravalvular leak (PVL) that progressed to grade 2 and 3+ (moderate/severe), respectively, during follow-up. Type of bicuspidy (Sievers classification) in these two patients was 0 and intraoperatively aortic annuli admitted the 25 mm calibrator. Among the 18 patients without PVL, no one had a type 0 large BAV. At 1 year, implantation of the 3f Enable SU bioprosthesis appears to be safe in patients with BAV type I and II, while in type 0 use of the SU valve seems to be safe only if the annular diameter is <25 mm. Larger studies are necessary to confirm our findings in order to clarify the indications for SU technology in the subset of bicuspid patients.
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http://dx.doi.org/10.1007/s00380-015-0790-xDOI Listing
November 2016

Restenosis after percutaneous coronary intervention for coronary chronic total occlusion. The central role of an optimized immediate post-procedural angiographic result.

Authors:
Karl Isaaz Antoine Gerbay Jérémy Terreaux Hazem Khamis Khalid Tammam Laure Richard Alexis Cerisier Michel Lamaud Antoine Da Costa

Int J Cardiol 2016 Dec 16;224:343-347. Epub 2016 Sep 16.

Division of Cardiology, University of Saint Etienne, Saint Etienne, France.

Background: Factors of restenosis after percutaneous coronary intervention (PCI) for chronic total coronary occlusion (CTO) have not been fully explored. In particular, although the last ACC/AHA guidelines on PCI suggest that a minimum diameter stenosis of 10% with an optimal goal of as close to 0% as possible should be the new benchmark for lesions treated by stenting, angiographic success of PCI for CTO remains in the literature most often defined as a <30% residual diameter stenosis. Whether an optimized immediate post-PCI angiographic result (OAR) defined by a minimal diameter stenosis as close to 0% is associated with a lower restenosis rate in this subset of coronary lesions remains unknown.

Methods: Therefore, we assessed by quantitative coronary analysis (QCA) both the immediate post-PCI and 6-month follow-up angiographic results of 170 successfully treated true CTO.

Results: Post-PCI QCA immediate residual diameter stenosis was <30% in all 170 CTOs and OAR defined as a ≤10% residual stenosis was achieved in 133 (78%). Global binary restenosis rate was 21% in the 170 lesions. Restenosis rates were 46% and 14% in the non-OAR group and in the OAR group, respectively (p<0.0001). Multivariate analysis showed that a non-OAR, a younger age and a retrograde approach were independent factors of restenosis.

Conclusion: Thus, an optimized immediate angiographic result with a minimal diameter stenosis as close to 0% as possible appears to be associated with a lower rate of restenosis after CTO PCI.
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http://dx.doi.org/10.1016/j.ijcard.2016.09.028DOI Listing
December 2016

Deferred stenting in acute ST elevation myocardial infarction.

Authors:
Karl Isaaz Antoine Gerbay

Lancet 2016 Oct;388(10052):1371

Division of Cardiology, Hôpital Nord Centre Hospitalier Universitaire de Saint-Étienne, 42100 Saint-Étienne, France.

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http://dx.doi.org/10.1016/S0140-6736(16)31739-1DOI Listing
October 2016

Robotic magnetic navigation for ablation of human arrhythmias.

Authors:
Antoine Da Costa Jean Baptiste Guichard Cécile Roméyer-Bouchard Antoine Gerbay Karl Isaaz

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

Unusual complication during a percutaneous coronary intervention for a bifurcation lesion using T and Protrusion technique.

Authors:
Antoine Gerbay Ambroise Duprey Marco Vola Karl Isaaz

Cardiovasc Revasc Med 2016 Jun 28;17(4):290-1. Epub 2016 Mar 28.

Division of Cardiology, University of Saint Etienne, Saint Etienne, France.

Our case reports the first migration of a stent already deployed at high pressure in the main vessel during a 2-stent strategy for a bifurcation lesion using T and protrusion technique. The Kissing balloon was not optimal and could have led to an insufficient strut/cell opening and then to LAD stent pulled back into the artery tree. This case report highlights the importance of an optimal Kissing Balloon in two stent bifurcation technique.
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http://dx.doi.org/10.1016/j.carrev.2016.03.013DOI Listing
June 2016

Is the new Micra-leadless pacemaker entirely safe?

Authors:
Antoine Da Costa Cécile Romeyer-Bouchard Jean Baptiste Guichard Antoine Gerbay Karl Isaaz

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

Closed chest human aortic valve removal and replacement: Technical feasibility and one year follow-up.

Authors:
Marco Vola Jean-François Fuzellier Salvatore Campisi Fréderic Roche Jean-Pierre Favre Karl Isaaz Jérôme Morel Antoine Gerbay

Int J Cardiol 2016 May 4;211:71-8. Epub 2016 Mar 4.

Cardiology Unit, Cardiovascular Diseases Department, University Hospital, St-Etienne, France.

Background: Minimally invasive aortic valve replacement has so far required a minithoracotomy or a ministernotomy. We present here the first series of totally endoscopic aortic valve replacement (TEAVR).

Methods: Between June 2013 and April 2015, 14 consecutive patients (12 males, mean age=76 ± 5.4 years) with a mean EuroSCORE II of 2.72 ± 0.03% underwent TEAVR. A five trocar setting was used in all patients: after ablation of the native valve, a Nitinol stented sutureless 3f Enable Medtronic valve, compressed into the main working trocar, was introduced into the thorax and then expanded in the aortic root.

Results: Among the 14 patients, a thoracoscopic approach was successful in 13 (92.8%) and conversion into an open surgery using the right anterior minithoracotomy was necessary to close the aortotomy in one case. Mean cross-clamping and cardiopulmonary (CPB) times were 112 ± 18 and 161 ± 31 min, respectively. All patients left the surgical unit within 8 days after the operation without any paravalvular leakage. There was no paravalvular regurgitation, conductive block or any major adverse event at a mean follow-up of 10 ± 4 months (range 2-16).

Conclusions: TEAVR is feasible and safe in a selected subset of patients. Closed chest surgery has the potential to become the future approach of the isolated aortic valve replacement in low risk patients but further technical refinement and larger studies are necessary to reduce operative durations and enhance reproducibility.
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http://dx.doi.org/10.1016/j.ijcard.2016.02.149DOI Listing
May 2016

Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment-Elevation Myocardial Infarction: The MIMI Study.

Authors:
Loic Belle Pascal Motreff Lionel Mangin Grégoire Rangé Xavier Marcaggi Antoine Marie Nadine Ferrier Olivier Dubreuil Gilles Zemour Géraud Souteyrand Christophe Caussin Nicolas Amabile Karl Isaaz Raphael Dauphin René Koning Christophe Robin Benjamin Faurie Laurent Bonello Stanislas Champin Cédric Delhaye François Cuilleret Nathan Mewton Céline Genty Magalie Viallon Jean Luc Bosson Pierre Croisille

Circ Cardiovasc Interv 2016 Mar;9(3):e003388

From the Departments of Cardiology and Radiology, Centre Hospitalier Annecy-Genevois, Annecy, France (L. Belle, L.M., A.M.); Department of Cardiology, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France (P.M., G.S.); Department of Cardiology, Les Hôpitaux de Chartres, Eure-et-Loir, France (G.R.); Department of Cardiology, Centre Hospitalier de Vichy, Vichy, France (X.M., N.F.); Department of Cardiology, Centre Hospitalier St Luc St Joseph, Lyon, France (O.D.); Department of Cardiology, Centre Hospitalier de Cannes, Cannes, France (G.Z.); Department of Cardiology, Institut Mutualiste Monsouris, Paris, France (C.C., N.A.); Department of Cardiology, Hopital Nord, University hospital of Saint-Étienne, Saint-Étienne, France (K.I.); Department of Cardiology, Centre Hospitalier Universitaire de La Croix Rousse, Lyon, France (R.D.); Department of Cardiology, Clinique Saint Hilaire, Rouen, France (R.K.); Department of Cardiology, Clinique Convert, Bourg en Bresse, France (C.R.); Cardiovascular Institute, Groupe Hospitalier Mutualiste, Grenoble, France (B.F.); Department of Cardiology, Centre Hospitalier Universaitaire Marseille Nord, France (L. Bonello); Department of Cardiology, Hôpital de Valence, Valence, France (S.C.); Department of Cardiology, Hôpital Cardiologique, Lille university hospital, Lille, France (C.D.); Department of Cardiology, Hospital of Macon, Macon, France (F.C.); Department of Cardiology, Clinical Investigation Center, INSERM 1407, Hôpital Cardiovasculaire Louis Pradel, Lyon, France (N.M.); Clinical Investigation Centre, University Hospital of Grenoble, Grenoble, France (C.G., J.L.B.); and Department of Radiology, Hôpital Nord, University Hospital of Saint-Étienne, Saint-Étienne, France (M.V., P.C.).

Background: Delayed stent implantation after restoration of normal epicardial flow by a minimalist immediate mechanical intervention aims to decrease the rate of distal embolization and impaired myocardial reperfusion after percutaneous coronary intervention. We sought to confirm whether a delayed stenting (DS) approach (24-48 hours) improves myocardial reperfusion, versus immediate stenting, in patients with acute ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Methods And Results: In the prospective, randomized, open-label minimalist immediate mechanical intervention (MIMI) trial, patients (n=140) with ST-segment-elevation myocardial infarction ≤12 hours were randomized to immediate stenting (n=73) or DS (n=67) after Thrombolysis In Myocardial Infarction 3 flow restoration by thrombus aspiration. Patients in the DS group underwent a second coronary arteriography for stent implantation a median of 36 hours (interquartile range 29-46) after randomization. The primary end point was microvascular obstruction (% left ventricular mass) on cardiac magnetic resonance imaging performed 5 days (interquartile range 4-6) after the first procedure. There was a nonsignificant trend toward lower microvascular obstruction in the immediate stenting group compared with DS group (1.88% versus 3.96%; P=0.051), which became significant after adjustment for the area at risk (P=0.049). Median infarct weight, left ventricular ejection fraction, and infarct size did not differ between groups. No difference in 6-month outcomes was apparent for the rate of major cardiovascular and cerebral events.

Conclusions: The present findings do not support a strategy of DS versus immediate stenting in patients with ST-segment-elevation infarction undergoing primary percutaneous coronary intervention and even suggested a deleterious effect of DS on microvascular obstruction size.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01360242.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.115.003388DOI Listing
March 2016

Sutureless 3F Enable Valve Replacement for Pure Aortic Regurgitation.

Authors:
Marco Vola Jean-François Fuzellier Amedeo Anselmi Salvatore Campisi Benjamain Haber Karl Isaaz Antoine Gerbay Vito Giovanni Ruggieri

J Card Surg 2015 Nov 4;30(11):796-800. Epub 2015 Oct 4.

Cardiovascular Surgery Unit, St-Etienne University Hospital, St-Etienne, France.

Background And Aim: We present our experience in the use of the sutureless valve in patients undergoing aortic valve replacement for pure aortic regurgitation.

Methods: Out of 167 patients who underwent sutureless aortic valve implantation with a Medtronic 3f Enable prosthesis in our unit between March 2011 and February 2014, 12 (7.1%) received a sutureless valve for pure aortic regurgitation.

Results: Mean age, logistic EuroSCORE, and left ventricular ejection fraction were 72 ± 5 years, 6.3 ± 2.9%, and 52.5 ± 15.3%, respectively. The sutureless valve could be successfully implanted in all cases; nine patients had a full sternotomy (associated coronary artery bypass graft in four cases and associated mitral surgery in five), one patient had a ministernotomy, and two had a thoracoscopic approach. Average cross-clamping and cardiopulmonary bypass times were 90 ± 30 and 127 ± 51 minutes, respectively. At the outpatient echocardiography, average mean gradient was 10.54 ± 4.99 mmHg and a grade I-II paravalvular leakage (PVL) was detected in the first patient of the cohort (ministernotomy approach). At a mean follow-up of 11.1 ± 5.5 months, average mean gradient was 9.75 ± 2.87 mmHg, no new PVL was detected, and the known PVL was stable. No pacemaker implantation was required.

Conclusions: Implantation of the 3f Enable sutureless valve is technically possible with pure aortic regurgitation in selected patients. Multicenter investigations are necessary to assess the mid-term benefits of such a device in this subset of patients.
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http://dx.doi.org/10.1111/jocs.12647DOI Listing
November 2015

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

Authors:
Antoine Da Costa Claire Tulane Virginie Dauphinot Jérémy Terreaux Cécile Romeyer-Bouchard Alexie Gate-Martinet Marie Levallois Karl Isaaz

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

Echocardiographic Findings in Healthy Elderly People with Unrecognized Sleep Disordered Breathing.

Authors:
Emilia Sforza Mouhamed Sabri Antoine DaCosta Karl Isaaz Jean Claude Barthélémy Frédéric Roche

J Clin Sleep Med 2015 Sep 15;11(9):975-80. Epub 2015 Sep 15.

Service de Physiologie Clinique et de l'Exercice (Pole Hospitalier NOL), CHU Nord, Faculté de Médecine Jacques Lisfranc, Université Jean Monnet, Saint-Etienne, France.

Objective: Sleep disordered breathing (SDB) is associated with cardiovascular disease such as hypertension and left ventricular hypertrophy in middle-aged patients; however, this association is not well described in the elderly. The aim of this study was to evaluate the impact of unrecognized SDB on cardiac function and remodeling in a population-based sample of healthy elderly without cardiac disease.

Methodology: A total of 405 healthy elderly (age ≥ 65 years) were examined by echocardiography and respiratory polygraphy. According to the apnea-hypopnea index (AHI), subjects were stratified in four categories: snorers (AHI < 5), mild (AHI: 5-15), moderate (AHI: 15-30), and severe (AHI > 30) cases.

Results: Comparative analysis between snorers and SDB cases revealed that left atrial (LA) diameter and surface increased according to SDB severity (p < 0.05) without differences in LA mass index. In subjects with an AHI > 30, an increase was found for LV end-diastolic and end-systolic dimension (p < 0.001), as well as for LV mass (p < 0.03) and LV index (p < 0.05). The current study showed a weak but significant correlation between altered LA and LV measurements versus AHI and hypoxemia indices (p < 0.001). In the regression analysis, AHI and hypoxemia had a minimal effect, body mass index and male gender being the most significant predictors.

Conclusions: In a population of healthy elderly with SDB, slight changes in left atrial and ventricular measurements occur in severe cases (AHI > 30). Irrespective of the lack of a strong association between SDB and cardiac dysfunction, the presence of slight cardiac pathology in severe SDB cases might be considered.

Clinical Trial Registration: NCT 00759304 and NCT 00766584.
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http://dx.doi.org/10.5664/jcsm.5006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4543257PMC
September 2015

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

Authors:
Antoine Da Costa Marie Levallois Cécile Romeyer-Bouchard Laurence Bisch Alexis Gate-Martinet Karl Isaaz

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

Endovascular repair of mitroaortic intervalvular fibrosa aneurysm after bentall surgery.

Authors:
Marco Vola Antoine Gerbay Salvatore Campisi Ambroise Duprey Fabien Heller Arnaud Patoir Jean Noel Albertini Jean Francois Fuzellier Karl Isaaz Jean Pierre Favre

Ann Thorac Surg 2015 Feb;99(2):702-4

Cardiovascular Surgery Unit, University Hospital, Saint-Étienne, France.

We report the first case of a successful transapical transcatheter treatment of a giant pseudoaneurysm originating from a rupture of the mitroaortic fibrosa that occurred 3 months after a Bentall procedure in a 81-year-old male patient. Because of the age of the patient and the location of the leak at the mitroaortic fibrosa, the risk of a conventional ascending aorta reoperation was considered too high, and a transcatheter approach was chosen. A transapical puncture was performed with a left minithoracotomy followed by a catheterization of the pseudoaneurysm neck and an 8-mm Amplatzer (St. Jude Medical, Saint Paul, MN, USA) device was delivered, resulting in a successful complete endovascular exclusion of the pseudo-aneurysmal sac.
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http://dx.doi.org/10.1016/j.athoracsur.2014.04.092DOI Listing
February 2015

Resolution of stress induced reversible myocardial SPECT defect in Wolf Parkinson White (WPW) syndrome.

Authors:
Antoine Gerbay Marco Vola Jeremy Terreaux Aline Steiner-Emptaz Antoine Da Costa Karl Isaaz

Int J Cardiol 2015 Jan 6;179:489-90. Epub 2014 Nov 6.

Division of Cardiology, University of Saint Etienne, Saint Etienne, France.

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http://dx.doi.org/10.1016/j.ijcard.2014.11.051DOI Listing
January 2015

Effect of coronary thrombus aspiration during primary percutaneous coronary intervention on one-year survival (from the FAST-MI 2010 registry).

Authors:
Etienne Puymirat Nadia Aissaoui Yves Cottin Gérald Vanzetto Didier Carrié Karl Isaaz Yann Valy Didier Tchetche François Schiele Philippe Gabriel Steg Tabassome Simon Nicolas Danchin

Am J Cardiol 2014 Dec 16;114(11):1651-7. Epub 2014 Sep 16.

Departement of Cardiology, European Hospital of Georges Pompidou, Assistance Publique des Hôpitaux de Paris (AP-HP), University Paris Descartes, Paris, France.

Results from randomized trials evaluating thrombus aspiration (TA) in patients with ST-elevation myocardial infarction (STEMI) are conflicting. We assessed 1-year survival in STEMI patients participating in the French Registry of Acute ST-Elevation and non-ST-Elevation Myocardial Infarction (FAST-MI) 2010 according to the use of TA during primary percutaneous coronary intervention (PCI). FAST-MI 2010 is a nationwide French registry that included 4,169 patients with acute myocardial infarction at the end of 2010 in 213 centers. Of those, 2,087 patients had STEMI, of whom 1,538 had primary PCI, with TA used in 671 (44%). Patients with TA were younger (61 ± 13.5 vs 63 ± 14 years), with a similar risk score of the Global Registry of Acute Coronary Events (140 ± 31 vs 143 ± 34) and a shorter median time from symptom onset (245 vs 285 minutes); location of acute myocardial infarction, history of myocardial infarction, PCI, or coronary artery bypass surgery did not differ significantly. Thirty-day mortality was 2.1% versus 2.1% (adjusted p = 0.18), and the rate of 1-year survival was 95.5% versus 94.8%. Using fully adjusted Cox multivariate analysis, hazard ratio for 1-year death was 1.13 (95% confidence interval 0.66 to 1.94). After propensity score matching (480 patients per group), 1-year survival was also similar with both strategies. In a real-world setting of patients admitted with STEMI, the use of TA during primary PCI was not associated with improved 1-year survival.
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http://dx.doi.org/10.1016/j.amjcard.2014.08.039DOI Listing
December 2014

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

Authors:
Alexie Gate-Martinet Antoine Da Costa Cécile Romeyer-Bouchard Laurence Bisch Marie Levallois Karl Isaaz

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.

Authors:
Antoine Da Costa Mouna Ben H'dech Cécile Romeyer-Bouchard Laurence Bisch Alexis Gate-Martinet Marie Levallois Karl Isaaz

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