Jean Claude Daubert

EHRA Expert Consensus Statement on the management of cardiovascular implantable electronic devices in patients nearing end of life or requesting withdrawal of therapy

The purpose of this Consensus Statement is to focus on implantable cardioverter-defibrillator (ICD) deactivation in patients with irreversible or terminal illness. This statement summarizes the opinions of the Task Force members, convened by the European Heart Rhythm Association (EHRA) and the Heart Rhythm Society (HRS), based on ethical and legal principles, as well as their own clinical, scientific, and technical experience. It is directed to all healthcare professionals who treat patients with implanted ICDs, nearing end of life, in order to improve the patient dying process. This statement is not intended to recommend or promote device deactivation. Rather, the ultimate judgement regarding this procedure must be made by the patient (or in special conditions by his/her legal representative) after careful communication about the deactivations consequences, respecting his/her autonomy and clarifying that he/she has a legal and ethical right to refuse it. Obviously, the physician asked to deactivate the ICD and the industry representative asked to assist can conscientiously object to and refuse to perform device deactivation.

Six year experience of transvenous left ventricular lead implantation for permanent biventricular pacing in patients with advanced heart failure: technical aspects

BACKGROUND Biventricular pacing has been proposed as an adjuvant to optimal medical treatment in patients with drug refractory heart failure caused by chronic left ventricular systolic dysfunction and intraventricular conduction delay. OBJECTIVE To assess the technical feasibility and long term results (over six years) of transverse left ventricular pacing with the lead inserted into a tributary vein of the coronary sinus. SUBJECTS From August 1994 to February 2000, left ventricular lead implantation was attempted in 116 patients who were eligible for biventricular pacing (mean (SD) age 67 (9) years, New York Heart Association (NYHA) functional class III/IV, left ventricular ejection fraction 22 (6)%, QRS duration 185 (26)u2009ms). RESULTS The overall implantation success rate was 88% (nu2009=u2009102). A learning curve was indicated by a progressive increase in success from 61% early on to 98% in the last year. The mean pacing threshold was 1.1 (0.7)u2009V/0.5u2009ms at the time of implantation and increased slightly up to 1.9 (0.9)u2009V/0.5u2009ms at the end of the follow up period (15 (13) months). The rate of acute and delayed left ventricular lead dislodgement decreased from 30% in the early years to 11% after 1999. During follow up, 19 patients required reoperation for delayed lead dislodgement or increase in left ventricular pacing threshold (nu2009=u200915), phrenic nerve stimulation (nu2009=u20093), or infection (nu2009=u20093). CONCLUSIONS Transverse left ventricular pacing through the coronary sinus is feasible and safe. The rate of implantation failure and of lead related problems has decreased greatly with increasing experience and with improvements in the equipment.

Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. Report of a policy conference of the European Society of Cardiology.

The European Commission announced in 2008 that a fundamental revision of the medical device directives is being considered in order to clarify and strengthen the current legal framework. The system for testing and approving devices in Europe was established >20 years ago as a New Approach to a previously little-regulated industry. It is recognized by many that the regulatory system has not kept pace with technological advances and changing patterns of medical practice. New legislation will be drafted during 2011, but medical experts have been little involved in this important process. This context makes it an opportune time for a professional association to advise from both clinical and academic perspectives about changes which should be made to improve the safety and efficacy of devices used in clinical practice and to develop more appropriate systems for their clinical evaluation and post-marketing surveillance. This report summarizes how medical devices are regulated and it reviews some serious clinical problems that have occurred with cardiovascular devices. Finally, it presents the main recommendations from a Policy Conference on the Clinical Evaluation of Cardiovascular Devices that was held at the European Heart House in January 2011.

Resumption of sinus rhythm in patients with heart failure and permanent atrial fibrillation undergoing cardiac resynchronization therapy: a longitudinal observational study

AIMSnTo investigate the temporal patterns, predictors, and prognostic impact of spontaneous sinus rhythm resumption (SRR) of heart failure (HF) patients with permanent atrial fibrillation (AF) treated with cardiac resynchronization therapy (CRT).nnnMETHODS AND RESULTSnThis multicentre, retrospective, longitudinal study analysed 330 consecutive HF patients with permanent AF treated with a CRT device (mean age 70 +/- 9 years, male 83%, ischaemic aetiology 44%, NYHA class III-IV 93%, mean QRS duration 167 +/- 40 ms, and mean ejection fraction 26 +/- 7%). Clinical, echocardiographic, and outcome data were collected during follow-up. Thirty-four patients experienced SRR after CRT (10.3%) at a median 4-month follow-up. The strongest independent predictors were end-diastolic diameter (EDD) [hazard ratios (HR) 4.03, 95% confidence intervals (95% CI) 1.43-11.36, P = 0.008], post-CRT QRS <or=150 ms (HR 2.63, 95% CI 1.02-6.67, P = 0.05), left atrium (LA) diameter <or=50 mm (HR 4.76, 95% CI 1.72-11.82, P = 0.002), and atrioventricular junction (AVJ) ablation (HR 4.27, 95% CI 1.54-11.84, P = 0.02). The coexistence of three predictors vs. zero to two predictors increased by 3.5-fold the likelihood of SRR; while the presence of all four factors improves the probability by a factor of 5.7-fold. Sinus rhythm resumption was associated with a significantly better long-term survival (log rank P = 0.03).nnnCONCLUSIONnOne in every 10 HF patients with permanent AF may experience SRR after CRT. Baseline EDD <or=65 mm, CRT-paced QRS <or=150 ms, LA <or=50 mm, and AVJ ablation appear to be predictive of this phenomenon.

Grupo de Trabajo de la Sociedad Europea de Cardiología (ESC) sobre marcapasos y terapia de resincronización cardiaca. Desarrollada en colaboración con la European Heart Rhythm Association.

(GRUPO DE TRABAJO DE LA SOCIEDAD EUROPEA DE CARDIOLOGÍA) Fernando Alfonso, MD, PhD, FESCa, Giuseppe Ambrosio, MD, PhD, FESCb, Fausto J. Pinto, MD, PhD, FESCc, Ernst E. Van der Wall, MD, PhD, FESC (Chairman of the Task Force) Anesti Kondili MD, Djamaleddine Nibouche MD, Karlen Adamyan MD, Kurt Huber MD, Hugo Ector MD, Izet Masic MD, Rumiana Tarnovska MD, Mario Ivanusa MD, Vladimír Stan¢ek MD, Jørgen Videbæk MD, Mohamed Hamed MD, Alexandras Laucevicius MD, Pirjo Mustonen MD, Jean-Yves Artigou MD, Ariel Cohen MD, Mamanti Rogava MD, Michael Böhm MD, Eckart Fleck MD, Gerd Heusch MD, Rainer Klawki MD, Panos Vardas MD, Christodoulos Stefanadis MD, József Tenczer MD, Massimo Chiariello MD, Joseph Elias MD, Halima Benjelloun MD, Olaf Rødevand MD, Piotr Kulakowski MD, Edgard Apetrei MD, Victor A. Lusov MD, Rafael G. Oganov MD, Velibor Obradovic MD, Gabriel Kamensky MD, Miran F. Kenda MD, Christer Höglund MD, Thomas F. Lüscher MD, René Lerch MD, Moufid Jokhadar MD, Habib Haouala MD, Vedat Sansoy MD, Valentin Shumakov MD, Adam Timmis MD*,

059: Clinical evidence of LBBB-induced cardiomyopathy: reversal by cardiac resynchronisation

Purpose Animal and clinical data have shown that left bundle branch block (LBBB) induces mechanical dyssynchrony in the left heart. In heart failure (HF) patients with low left ventricular (LV) ejection fraction, cardiac resynchronisation therapy (CRT) is much more efficient when typical LBBB is present. It has been postulated that lone LBBB could induce a progressive decline in LV function via dyssynchrony leading to chronic HF with possible recovery after CRT. However, the clinical evidence to support this hypothesis is weak. The aim of this work was to study the prevalence and characteristics of LBBB-induced cardiomyopathy cured by CRT. Methods All the patients referred to our center for CRT implantation from 2007 to 2011 (N=375) were investigated for LBBB history. Patients were included if they presented an original syndrome consisting on: – history of typical LBBB for ≥5 years, – no evidence of structural heart disease at the time of LBBB diagnosis, – progressive development of LV systolic dysfunction and HF symptoms (NYHA class II-IV), – presence of major mechanical dyssynchrony by cardiac imaging, – absence of other etiology for cardiomyopathy, – hyper-response to CRT as indicated by LVEF>45% after 1 year. Results 7 patients (2% of all screened pts) had the described syndrome. The main patient characteristics and follow-up data are summarized in the following tables. Interestingly, two patients had HF symptoms and LV dysfunction recurrence after 3 and 6 years of CRT, respectively after withdraw of CRT due to device removal in one (breast cancer) and battery depletion in the other. After CRT resume, hyper-response was quickly re-observed in these two cases. Conclusion These original data support the concept of LBBB-induced cardiomyopathy with possible cure by CRT. The exact prevalence of the syndrome, the time needed to develop and predictive factors need to be assessed in further prospective epidemiological studies. Table – Main characteristics. Patient characteristics at time of LBBB diagnosis Male 4 Age (years) 51 (36 to 60) Chest pain as 1st symptom 2 Rate-dependent LBBB 3 QRS duration (msec) 136 (100 to 160) Time to HF symptoms (years) 11,5 (5 to 21) Time to CRT (years) 13,5 (16 to 22) Table – Follow up data. Pre- and post CRT Pre-implant 1 year * NYHA class I/II/III 0/3/4 5/2/0 * QRS duration (msec) 162 (150 to 180) 124 (110 to 135) * NT-pro BNP (pg/ml) 2275±3200 159±11 * LVEF (%) 30 (20 to 39) 53 (45 to 62) * LVEDD (mm) 63 (50 to 76) 50 (44 to 56) * p

171: Risk scores versus pragmatic clinical assessment to predict operative risk in aortic valve replacement for aortic stenosis

Background Preoperative risk assessment of cardiac surgery is based on international validated scores. However their additional value above simple clinical assessment (CA) remains controversial. The aim of this study was to compare CA by cardiologists with the 5 most commonly used scores (additive and logistic EuroSCORE, EuroSCORE II, STS-score, Ambler-score) to predict perioperative mortality in patients undergoing aortic valve replacement for aortic stenosis. Methods From October 2009 to November 2011, 314 consecutive patients (73±9,7 years; 29% octogenarians) were included. A surgical coronary revascularization was associated to aortic valve replacement in 22%. According to the expected mortality by CA, patients were split in 4 groups: “low” mortality risk [0–3.9%], “intermediate” [4–6.9%], “high” [7–9.9%] and “very high” ≥10%. The 5 scores were calculated for all the patients. Results Observed total operative mortality was 5,7%. The distribution of predicted mortality in the 4 groups was highly different according to the method. The positive predictive value (PPV) of each method was calculated for the 21% most at risk patients (corresponding to the 64 patients ranked in “high” and “very high” mortality risk groups by CA) resulting in PPV=17.2% for EuroSCORE II, 14.1% for CA and STS-score, 10.9% for additive EuroSCORE and logistic EuroSCORE and 10% for Ambler score. Predictive values of “low” and “intermediate” mortality risks were not significantly different depending on the methods (PPV between 2.8 and 4.4%). Conclusion pragmatic CA remains useful to predict operative risk in patients with surgical aortic valve replacement and to balance the different international scores.