Xavier Armoiry

Initial French experience of percutaneous mitral valve repair with the MitraClip: a multicentre national registry.

BACKGROUND Percutaneous mitral valve repair (MVR) using the MitraClip(®) is a new option for severe mitral regurgitation (MR). AIM To describe initial French experience regarding short-term and mid-term safety and efficacy. METHODS A multicentre cohort reported experience of percutaneous MVR using the MitraClip(®) in French centres from December 2010 to September 2012. All patients were judged inoperable or at high surgical risk. Short-term and mid-term safety and efficacy results are presented. RESULTS Sixty-two patients (72.7±11.4years; 71.7% men; 81.0% New York Heart Association [NYHA] class III or IV; logistic Euroscore 18.7±13.1%; 93.3% MR≥grade 3; 73.8% secondary MR) underwent percutaneous MVR using the MitraClip(®) under general anaesthesia. Procedural success was 95.2% (83.1% of patients received one clip; 16.9% received two clips). At discharge, 88.2% of implanted patients had a residual MR≤grade 2. Transthoracic echocardiography showed a significant decrease in ejection fraction (39.9±14.8% pre vs. 36.2±14.3% post), end-diastolic diameter (63.8±10.6mm vs. 61.4±12.3mm, respectively) and systolic pulmonary pressure (52.1±13.9mmHg vs. 44.7±10.9mmHg, respectively). The in-hospital mortality rate was 3.2%. The survival rate at 6-month follow-up was estimated at 83.1%, with 90.9% of patients in NYHA class I or II and residual MR≤grade 2 in 80% of cases. CONCLUSION This initial French experience, despite being in its learning phase, showed promising results in patients considered ineligible for surgery, as observed in more experienced centres. Randomized studies are mandatory to confirm these preliminary data.

The cost-effectiveness of tumor-treating fields therapy in patients with newly diagnosed glioblastoma.

BACKGROUND There is strong concern about the costs associated with adding tumor-treating fields (TTF) therapy to standard first-line treatment for glioblastoma (GBM). Hence, we aimed to determine the cost-effectiveness of TTF therapy for the treatment of newly diagnosed patients with GBM. METHODS We developed a 3-health-state Markov model. The perspective was that of the French Health Insurance, and the horizon was lifetime. We calculated the transition probabilities from the survival parameters reported in the EF-14 trial. The main outcome measure was incremental effectiveness expressed as life-years gained (LYG). Input costs were derived from the literature. We calculated the incremental cost-effectiveness ratio (ICER) expressed as cost/LYG. We used 1-way deterministic and probabilistic sensitivity analysis to evaluate the model uncertainty. RESULTS In the base-case analysis, adding TTF therapy to standard of care resulted in increases of life expectancy of 4.08 months (0.34 LYG) and €185 476 per patient. The ICER was €549 909/LYG. The discounted ICER was €596 411/LYG. Parameters with the most influence on ICER were the cost of TTF therapy, followed equally by overall survival and progression-free survival in both arms. The probabilistic sensitivity analysis showed a 95% confidence interval of the ICER of €447 017/LYG to €745 805/LYG with 0% chance to be cost-effective at a threshold of €100 000/LYG. CONCLUSION The ICER of TTF therapy at first-line treatment is far beyond conventional thresholds due to the prohibitive announced cost of the device. Strong price regulation by health authorities could make this technology more affordable and consequently accessible to patients.

Extracorporeal life support for refractory out-of-hospital cardiac arrest: Should we still fight for? A single-centre, 5-year experience

BACKGROUND Cardiopulmonary resuscitation displays low survival rate after out-of-hospital cardiac arrest (OHCA). Extracorporeal life support (ECLS) could be suggested as a rescue therapeutic option in refractory OHCA. The aim of this report is to analyze our experience of ECLS implantation for refractory OHCA. METHODS We performed a retrospective observational analysis of our prospectively collected database. Patients were divided into a shockable rhythm (SH-R) and a non-shockable rhythm (NSH-R) group according to cardiac rhythm at ECLS implantation. The primary endpoint was survival to hospital discharge with good neurological recovery. RESULTS From January 2010 to December 2014 we used ECLS in 68 patients (SH-R, n=19, 27.9% vs. NSH-R, n=49, 72.1%) for refractory OHCA. The clinical profile before ECLS implantation was comparable between the groups. Eight (11.7%) patients were successfully weaned from ECLS (SH-R=31.5% vs. NSH-R=4.0%, p=0.01) after a mean period of support of 2.1 days (SH-R=4.1 days vs. NSH-R=1.4 days, p=0.01). Six (8.8%) patients survived to discharge (SH-R=31.5% vs. NSH-R=0%, p=0.00). In the SH-R group 50% of the survivors were discharged without neurological complications. CONCLUSIONS ECLS for refractory OHCA should be limited in consideration of its poor, especially neurological, outcome. Non-shockable rhythms could be considered as a formal contraindication allowing a concentration of our efforts on the shockable rhythms, where the chances of success are substantial.

Endovascular Treatment of Intracranial Aneurysms with the WEB Device: A Systematic Review of Clinical Outcomes

BACKGROUND AND PURPOSE: Despite the improvement in technology, endovascular treatment of bifurcation intracranial wide-neck aneurysms remains challenging, mainly due to the difficulty of maintaining coils within the aneurysm sac without compromising the patency of bifurcation arteries. The Woven EndoBridge (WEB) device is a recent intrasaccular braided device specifically dedicated to treating such aneurysms with a wide neck by disrupting the flow in the aneurysmal neck and promoting progressive aneurysmal thrombosis. MATERIALS AND METHODS: Using several health data bases, we conducted a systematic review of all published studies of WEB endovascular treatment in intracranial aneurysms from 2010 onward to evaluate its efficacy and safety profile. RESULTS: The literature search identified 6 relevant studies (7 articles) including wide-neck bifurcation aneurysms in ≥80% of cases. Clinical data supporting the efficacy and safety of the WEB are limited to noncomparative cohort studies with large heterogeneity from a methodologic standpoint. The WEB deployment was feasible with a success rate of 93%–100%. Permanent morbidity (mRS of >1 at last follow-up) and mortality were measured at 2.2%–6.7% and 0%–17%, respectively. The adequate occlusion rate (total occlusion or neck remnant) varied between 65% and 85.4% at midterm follow-up (range, 3.3–27.4 months). CONCLUSIONS: Endovascular treatment of bifurcation wide-neck aneurysms with the WEB device is feasible and allows an acceptably adequate aneurysm occlusion rate; however, the rate of neck remnants is not negligible. The WEB device needs further clinical and anatomic evaluation with long-term prospective studies, especially of the risk of WEB compression. Prospective controlled studies should be encouraged.

Direct costs associated with the management of progressive early onset scoliosis: Estimations based on gold standard technique or with magnetically controlled growing rods

BACKGROUND The main disadvantage of the surgical management of early onset scoliosis (EOS) using conventional growing rods is the need for iterative surgical procedures during childhood. The emergence of an innovative device using distraction-based magnetically controlled growing rods (MCGR) provides the opportunity to avoid such surgeries and therefore to improve the patients quality of life. HYPOTHESIS Despite the high cost of MCGR and considering its potential impact in reducing hospital stays, the use of MCGR could reduce medical resource consumption in a long-term view in comparison to traditional growing rod (TGR). MATERIALS AND METHODS A cost-simulation model was constructed to assess the incremental cost between the two strategies. The cost for each strategy was estimated based on probability of medical resource consumption determined from literature search as well as data from EOS patients treated in our centre. Some medical expenses were also estimated from expert interviews. The time horizon chosen was 4 years as from first surgical implantation. Costs were calculated in the perspective of the French sickness fund (using rates from year 2013) and were discounted by an annual rate of 4%. Sensitivity analyses were conducted to test model strength to various parameters. RESULTS With a time horizon of 4 years, the estimated direct costs of TGR and MCGR strategies were 49,067 € and 42,752 €, respectively leading to an incremental costs of 6135 € in favour of MCGR strategy. In the first case, costs were mainly represented by hospital stays expenses (83.9%) whereas in the other the cost of MCGR contributed to 59.5% of the total amount. In the univariate sensitivity analysis, the tariffs of hospital stays, the tariffs of the MCG, and the frequency of distraction surgeries were the parameters with the most important impact on incremental cost. DISCUSSION MCGR is a recent and promising innovation in the management of severe EOS. Besides improving the quality of life, its use in the treatment of severe EOS is likely to be offset by lower costs of hospital stays. LEVEL OF EVIDENCE (WITH STUDY DESIGN) Level IV, economic and decision analyses, retrospective study.

One-Year Angiographic Follow-Up after WEB-SL Endovascular Treatment of Wide-Neck Bifurcation Intracranial Aneurysms.

BACKGROUND AND PURPOSE: Endovascular coiling of wide-neck intracranial aneurysms is associated with low rates of initial angiographic occlusion and high rates of recurrence. The WEB intrasaccular device has been developed specifically for this indication. To date, there has been no report of the long-term follow-up of a series of patients with aneurysms treated with this type of device, to our knowledge. Our aim was to evaluate a 1-year follow-up of angiographic results in a prospective single-center series of patients treated with the WEB-Single-Layer (SL) device. MATERIALS AND METHODS: All patients treated with the WEB-SL device in our center between August 2013 and May 2014 were prospectively included. One-year angiographic outcomes were assessed. Results at follow-up were graded as complete occlusion, neck remnant, or residual aneurysm. RESULTS: Eight patients with 8 unruptured wide-neck aneurysms were enrolled in this study. Average dome width was 7.5 mm (range, 5.4–10.7 mm), and average neck size was 4.9 mm (range, 2.6–6.5 mm). One-year angiographic follow-up obtained in all aneurysms included 1 complete aneurysm occlusion (12.5%), 6 neck remnants (75%), and 1 aneurysm remnant (12.5%). Of 8 aneurysms, worsening of aneurysm occlusion was observed in 2 (25%) by compression of the WEB device. There was no angiographic recurrence of initially totally occluded aneurysms. No bleeding was observed during the follow-up period. CONCLUSIONS: Endovascular therapy of intracranial aneurysms with the WEB-SL device allows treatment of wide-neck aneurysms with a high rate of neck remnant at 1 year, at least partially explained by WEB compression. Initial size selection and technologic improvements could be an option for optimization of aneurysm occlusion in WEB-SL treatment.

The MITRA-FR study: design and rationale of a randomised study of percutaneous mitral valve repair compared with optimal medical management alone for severe secondary mitral regurgitation

AIMS Percutaneous mitral valve repair (pMVR) is a new therapeutic option for mitral valve regurgitation. Positive preliminary results in non-randomised studies have been published supporting the use of the MitraClip system in patients with secondary mitral regurgitation (MR) and poor left ventricular (LV) function contraindicated to surgery. The aim of the MITRA-FR study is to provide a higher level of evidence for the efficacy of the MitraClip device in this setting. METHODS AND RESULTS The MITRA-FR study is a national, multicentre, investigator-initiated, open-label, randomised trial to evaluate the benefits and safety of pMVR using the MitraClip system plus optimal medical therapy (OMT) compared with OMT alone (control) in patients with severe symptomatic secondary MR contraindicated to surgical repair. The trial aims to enrol 144 MitraClip-treated subjects and 144 control (OMT alone) patients. The primary endpoint is a composite of all-cause mortality and unplanned hospitalisations for heart failure at 12 months after randomisation CONCLUSIONS MITRA-FR is a randomised controlled national trial designed to evaluate the performance of pMVR in comparison to OMT in patients with severe symptomatic secondary MR contraindicated to cardiac surgery.

Interest of Flow Diversion Prostheses in the Management of Unruptured Intracranial Aneurysms

Flow diversion prostheses represent a new endovascular approach aimed at treating patients with large wide-neck aneurysms. Our objective is to present this new technology, to review the clinical studies on efficacy, and to emphasize its current limits. Flow diversion prostheses consist of a cylinder made of a large number of braided microfilaments providing a large metallic surface when deployed and inducing a blood flow diversion outside the aneurysm. Two different brands are currently available. Clinical data supporting their efficacy are currently limited to six non comparative cohort studies that included between 18 and 107 patients. Procedural implantation was shown to be feasible in more than 90% and safe with a thirty-day mortality between 2.8 and 5.5%. Complete occlusion rates at twelve months varied between 85.7 and 100%. Even though promising, the current status of flow diversion prostheses needs further evaluation with randomized, prospective, clinical trials with comparison to conventional strategies including endovascular coiling or surgical clipping.

A Direct Aspiration First Pass Technique (ADAPT) for acute stroke therapy: a systematic review and meta‐analysis

A direct aspiration first pass technique (ADAPT), involving the first‐line use of a large‐bore distal aspiration catheter, is a new strategy in the mechanical thrombectomy of acute ischemic stroke caused by large‐vessel occlusion. However, its impact on reperfusion rates, clinical outcomes and complication rates has not been fully examined.

The magnitude and mechanisms of the weekend effect in hospital admissions: A protocol for a mixed methods review incorporating a systematic review and framework synthesis

BackgroundGrowing literature has demonstrated that patients admitted to hospital during weekends tend to have less favourable outcomes, including increased mortality, compared with similar patients admitted during weekdays. Major policy interventions such as the 7-day services programme in the UK NHS have been initiated to reduce this weekend effect, although the mechanisms behind the effect are unclear. Here, we propose a mixed methods review to systematically examine the literature surrounding the magnitude and mechanisms of the weekend effect.MethodsMEDLINE, CINAHL, HMIC, EMBASE, EthOS, CPCI and the Cochrane Library were searched from Jan 2000 to April 2015 using terms related to ‘weekends or out-of-hours’ and ‘hospital admissions’. The 5404 retrieved records were screened by the review team, and will feed into two component reviews: a systematic review of the magnitude of the weekend effect and a framework synthesis of the mechanisms of the weekend effect. A repeat search of MEDLINE will be conducted mid-2016 to update both component reviews. The systematic review will include quantitative studies of non-specific hospital admissions. The primary outcome is the weekend effect on mortality, which will be estimated using a Bayesian random effects meta-analysis. Weekend effects on adverse events, length of hospital stay and patient experience will also be examined. The development of the framework synthesis has been informed by the initial scoping of the literature and focus group discussions. The synthesis will examine both quantitative and qualitative studies that have compared the processes and quality of care between weekends and weekdays, and explicate the underlying mechanisms of the weekend effect.DiscussionThe weekend effect is a complex phenomenon that has major implications for the organisation of health services. Its magnitude and underlying mechanisms have been subject to heated debate. Published literature reviews have adopted restricted scopes or methods and mainly focused on quantitative evidence. This proposed review intends to provide a comprehensive and in-depth synthesis of diverse evidence to inform future policy and research aiming to address the weekend effect.Systematic review registrationPROSPERO 2016: CRD42016036487