Jean-Claude Laborde

Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr) corevalve revalving system: results from the multicentre, expanded evaluation registry 1-year following CE mark approval

AIMS To describe the procedural performance and 30-day outcomes following implantation using the 18 Fr CoreValve Revalving System (CRS) as part of the multicentre, expanded evaluation registry, 1-year after obtaining CE mark approval. METHODS AND RESULTS Patients with symptomatic severe aortic stenosis and logistic Euroscore > or =15%, or age > or =75 years, or age > or =65 years associated with pre-defined risk factors, and for whom a physician proctor and a clinical specialist were in attendance during the implantation and who collected the clinical data, were included. From April 2007, to April 2008, 646 patients with a mean age of 81 +/- 6.6 years, mean aortic valve area 0.6 +/- 0.2 cm2, and logistic EuroSCORE of 23.1 +/- 13.8% were recruited. After valve implantation, the mean transaortic valve gradient decreased from 49.4 +/- 13.9 to 3 +/- 2 mmHg. All patients had paravalvular aortic regurgitation < or = grade 2. The rate of procedural success was 97%. The procedural mortality rate was 1.5%. At 30 days, the all-cause mortality rate (i.e, including procedural) was 8% and the combined rate of death, stroke and myocardial infarction was 9.3%. CONCLUSIONS The results of this study demonstrate the high rate of procedural success and a low 30-day mortality in a large cohort of high-risk patients undergoing transcatheter aortic valve implantation (TAVI) with the CRS.

Transcatheter Aortic Valve Implantation for Pure Severe Native Aortic Valve Regurgitation

OBJECTIVES This study sought to collect data and evaluate the anecdotal use of transcatheter aortic valve implantation (TAVI) in pure native aortic valve regurgitation (NAVR) for patients who were deemed surgically inoperable BACKGROUND Data and experience with TAVI in the treatment of patients with pure severe NAVR are limited. METHODS Data on baseline patient characteristics, device and procedure parameters, echocardiographic parameters, and outcomes up to July 2012 were collected retrospectively from 14 centers that have performed TAVI for NAVR. RESULTS A total of 43 patients underwent TAVI with the CoreValve prosthesis (Medtronic, Minneapolis, Minnesota) at 14 centers (mean age, 75.3 ± 8.8 years; 53% female; mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation), 26.9 ± 17.9%; and mean Society of Thoracic Surgeons score, 10.2 ± 5.3%). All patients had severe NAVR on echocardiography without aortic stenosis and 17 patients (39.5%) had the degree of aortic valvular calcification documented on CT or echocardiography. Vascular access was transfemoral (n = 35), subclavian (n = 4), direct aortic (n = 3), and carotid (n = 1). Implantation of a TAVI was performed in 42 patients (97.7%), and 8 patients (18.6%) required a second valve during the index procedure for residual aortic regurgitation. In all patients requiring second valves, valvular calcification was absent (p = 0.014). Post-procedure aortic regurgitation grade I or lower was present in 34 patients (79.1%). At 30 days, the major stroke incidence was 4.7%, and the all-cause mortality rate was 9.3%. At 12 months, the all-cause mortality rate was 21.4% (6 of 28 patients). CONCLUSIONS This registry analysis demonstrates the feasibility and potential procedure difficulties when using TAVI for severe NAVR. Acceptable results may be achieved in carefully selected patients who are deemed too high risk for conventional surgery, but the possibility of requiring 2 valves and leaving residual aortic regurgitation remain important considerations.

Results of percutaneous and transapical transcatheter aortic valve implantation performed by a surgical team.

OBJECTIVE Transcatheter aortic valve implantation has been performed by several groups, most of them either specializing on the transapical (surgeons) or the percutaneous femoral transarterial approach (cardiologists). We achieved both transapical and percutaneous transcatheter valve implantation by a surgical team in a hybrid suite. METHODS Since June 2007, 137 patients (n=78 female, mean age 81+/-7 years) underwent transcatheter aortic valve implantation (n=109 transfemoral, n=3 via subclavian artery, n=2 directly through ascending aorta, n=23 transapical) with the CoreValve (n=114) or the Edwards Sapien (n=23) prosthesis. RESULTS Thirty-day mortality was 12.4% in this patient cohort. One hundred and eight patients (78.8%) are alive at a mean follow-up of 97+/-82 days. Pacemaker implantation due to postoperative AV block was performed in 27 patients (19.7%), and 7 patients (5.1%) sustained neurological events. Patients improved in NYHA class (from 3.1+/-0.3 to 1.9+/-0.5, p<0.001) and in self-assessed health state (from 55+/-17% to 68+/-16%, p<0.001) at one-month follow-up. Echocardiographic assessment revealed excellent hemodynamic function of the prostheses with a mean aortic gradient (MAG) of 11.9+/-4.4 mmHg and an effective orifice area (EOA) of 1.6+/-0.4 cm(2) at discharge and a MAG of 11.0+/-4.2 mmHg and an EOA of 1.6+/-0.3 cm(2) at six months FU. CONCLUSIONS Transcatheter aortic valve implantation has become an alternative technique for the treatment of aortic stenosis with reasonable short- and mid-term results at our institution. With the opportunity to treat aortic stenosis by conventional surgical valve replacement and transapical and percutaneous transcatheter procedures, the technique of lowest risk for the individual patient can be chosen and performed by one team.

Transcatheter aortic valve implantation for stenosed and regurgitant aortic valve bioprostheses CoreValve for failed bioprosthetic aortic valve replacements.

Transcatheter aortic valve implantation is increasingly being used to treat severe aortic stenosis in patients with high operative risk. In an aging population the incidence of aortic stenosis is rising, and increasing numbers of elderly patients are undergoing aortic valve replacement with bioprosthetic valves. Therefore, there is a corresponding increase in prosthetic degeneration. This presents cardiologists with a cohort of patients for whom the risk of re-do aortic valve surgery is prohibitive. We present the first series of such patients with degenerative bioprosthetic stenosis or regurgitation successfully treated with CoreValve (Medtronic, Luxembourg) implantation.

Percutaneous aortic valve implants under sedation: our initial experience.

We have developed an approach where percutaneous aortic valve (PAVI) procedures are done under remifentanil‐based sedation administered by an anesthetist. We report here our initial experience.

First successful aortic valve implantation with the CoreValve ReValving System via right subclavian artery access: a case report.

We successfully implanted a bioprosthetic aortic valve via the right subclavian artery within the framework of the CoreValve transapical aortic valve replacement (TAVR) ReValving (CoreValve, Irvine, CA, USA) clinical trial on November 20, 2007, at the Clinic for Cardiovascular Surgery at the German Heart Center Munich, Technical University Munich. The self-expanding aortic valve prosthesis is primarily designed for retrograde delivery across the aortic valve. The described approach via the right subclavian artery was performed because of severe peripheral vascular disease of the femoral and iliac arteries, as well as the left subclavian artery, and because a transapical delivery system was not available at the time of surgery.

Novel therapeutic aspects of percutaneous aortic valve replacement with the 21F CoreValve Revalving™ System

Aims: Percutaneous aortic valve replacement (PAVR) is an emerging therapy for nonsurgical patients with severe aortic stenosis (AS). We investigated whether novel therapeutic approaches may facilitate AVR outcomes for high‐risk patients. Methods and Results: Eleven patients [n = 6 (54%) men] aged 82 ± 10 years underwent PAVR after being refused for open surgery. The mean±SD AV area and left ventricular ejection fraction (LVEF) of these patients was 0.56 ± 0.19 cm2 and 49 ± 17%, respectively, with severe functional limitation (NYHA class III (n = 8) and IV (n = 3)). One patient underwent PAVR combined with simultaneous percutaneous coronary intervention (PCI). Two male patients needed left iliac artery angioplasty. A percutaneous ventricular assist device (PVAD) was used in the most recent case. Compared with pre‐PAVR, mean AV area (1.3 ± 0.4 cm2; P < 0.001) and LVEF (56 ± 11%; P < 0.001) increased. One man had a peri‐procedural stroke and died 5 days post‐PAVR. Four other patients died within 4 months of hospital discharge. The median duration of survival of the survivors was 305 (range 249–431) days. Conclusions: Novel percutaneous techniques facilitate CoreValve PAVR (21 Fr.). Future lower profile devices (e.g. 18 Fr. Generation III CoreValve) should permit inclusion of a broader spectrum of high‐risk patients. PAVR may evolve toward a full percutaneous approach.

CoreValve transcatheter aortic valve implantation via the subclavian artery: comparison with the transfemoral approach.

To the Editor: Transcatheter aortic valve implantation (TAVI) has emerged as a promising alternative to surgical aortic valve replacement for patients with severe aortic stenosis considered to be at high operative risk. TAVI is most commonly performed via the femoral artery. However, the large-

Comparison of Magnetic Resonance Imaging of Aortic Valve Stenosis and Aortic Root to Multimodality Imaging for Selection of Transcatheter Aortic Valve Implantation Candidates

The purpose of the present study was to compare the aortic valve area, aortic valve annulus, and aortic root dimensions measured using magnetic resonance imaging (MRI) with catheterization, transthoracic echocardiography (TTE), and transesophageal echocardiography (TEE). An optimal prosthesis--aortic root match is an essential goal when evaluating patients for transcatheter aortic valve implantation. Comparisons between MRI and the other imaging techniques are rare and need validation. In 24 consecutive, high-risk, symptomatic patients with severe aortic stenosis, aortic valve area was prospectively determined using MRI and direct planimetry using three-dimensional TTE and calculated by catheterization using the Gorlin equation and by Doppler echocardiography using the continuity equation. Aortic valve annulus and the aortic root dimensions were prospectively measured using MRI, 2-dimensional TTE, and invasive aortography. In addition, aortic valve annulus was measured using TEE. No differences in aortic valve area were found among MRI, Doppler echocardiography, and 3-dimensional TTE compared with catheterization (p = NS). Invasive angiography underestimated aortic valve annulus compared with MRI (p <0.001), TEE (p <0.001), and 2-dimensional TTE (p <0.001). Two-dimensional TTE tended to underestimate the aortic valve annulus diameters compared to TEE and MRI. In contrast to 2-dimensional TTE, 3 patients had aortic valve annulus beyond the transcatheter aortic valve implantation range using TEE and MRI. In conclusion, MRI planimetry, Doppler, and 3-dimensional TTE provided an accurate estimate of the aortic valve area compared to catheterization. MRI and TEE provided similar and essential assessment of the aortic valve annulus dimensions, especially at the limits of the transcatheter aortic valve implantation range.

Percutaneous implantation of an aortic valve prosthesis.

Recently, percutaneous aortic valve implantation has become an alternative technique to surgical valve replacement in patient at high risk for surgery. Our animal experimentation evaluated the technical feasibility of aortic valve replacement using a bovine pericardium valve sutured on a self‐expandable stent in a sheep model. Precise implantation with satisfactory attachment on the adjacent tissues and absence of migration was obtain in 8 out of 14 animals. This study confirmed the feasibility of the endovascular implantation of a pericardium valve sutured on a self‐expandable stent in a sheep model.