Bicuspid aortic valve sizing for transcatheter aortic valve implantation: Development and validation of an algorithm based on multi-slice computed tomography.

BACKGROUND: No indication are available for transcatheter aortic valve implantation (TAVI) sizing in bicuspid aortic valve (BAV). Aim of the study is to develop and validate a Multi-Slice Computed Tomography (MSCT)-based algorithm for transcatheter heart valve (THV) sizing in patients with stenotic BAV under evaluation for TAVI. METHODS: A two steps method was applied: 1)evaluation of a cohort of 19 consecutive patients with type I BAV stenosis undergoing TAVI through pre and post-procedural MSCT, and development of an algorithm for THV sizing; 2)validation of the algorithm on a new cohort of 21 patients. RESULTS: In the first cohort, a high correlation was found between the raphe-level area measured at pre-procedural MSCT and the smallest THV area measured at post-procedural MSCT (p < 0.001). Moreover, reduced THV expansion was observed among patients with higher calcium burden (p = 0.048). Then, a new algorithm for TAVI sizing in BAV was develop (CASPER: Calcium Algorithm Sizing for bicusPid Evaluation with Raphe). This algorithm is based on the reassessment of the perimeter/area derived annulus diameter, according to three main anatomical features: 1) the ratio between raphe length and annulus diameter; 2)calcium burden; 3)calcium distribution in relation to the raphe. The algorithm was then validated in a new cohort of 21 patients, achieving 100% of procedural success and excellent TAVI performance. CONCLUSION: MSCT assessment of raphe length, calcium burden and its distribution is of crucial relevance in the pre-procedural evaluation of patients with BAV. These anatomical features can be combined in a new and simple algorithm for TAVI sizing.

First-in-man experience of percutaneous aortic valve replacement using self-expanding corevalve prosthesis.

OBJECTIVE: Percutaneous aortic valve replacement is a new emerging method for nonsurgical replacement of aortic valve in patients with severe aortic stenosis. We report the first-in-man case of percutaneous aortic valve replacement with self-expanding Core Valve aortic prosthesis. METHODS AND RESULTS: The procedure was performed on 12 July 2004 on a 62 years patient with severe aortic stenosis (peak systolic gradients across aortic valve being 90 mm Hg), moderately severe aortic regurgitation and preserved left ventricular systolic function. The patient had associated morbidities like renal failure (raised blood urea nitrogen and serum creatinine levels) and end-stage carcinoma of lung. Valve implantation was performed under general anesthesia with extracorporeal support using the retrograde approach. The patient was adequately screened prior to the procedure. The device was implanted successfully with post implantation peak systolic gradient across aortic valve being only 16 mm Hg. However, this patient died after four days due to renal failure and bleeding diathesis leading to multiorgan failure. CONCLUSIONS: Percutaneous implantation of self-expanding CoreValve prosthesis in patients with severe aortic stenosis with or without aortic regurgitation is feasible. Long-term studies will determine its future.

First percutaneous transcatheter aortic valve-in-valve implant with three year follow-up.

OBJECTIVES: This study was conducted to report the clinical, hemodynamic, and iconographic outcomes of the longest survivor of the global CoreValve experience. BACKGROUND: Early results of percutaneous heart valve (PHV) implantation for severe symptomatic aortic stenosis (AS) have been encouraging, with mid term survival up to 2 years; however longer durability term is unknown. Although a PHV has been implanted in a degenerated surgical bioprosthesis, the feasibility of a PHV-in-PHV has not been demonstrated. METHODS: A patient with severe refractory heart failure due to severe aortic regurgitation (AR) and moderate AS, underwent CoreValve prosthesis implantation. The PHV was deployed too proximal into the left ventricular outflow tract, resulting in severe AR through the frame struts. Using the first PHV as a landmark, a second CoreValve was then deployed slightly distal to the first, with trivial residual paravalvular leak. RESULTS: The second CoreValve expanded well with proper function. Transvalvular gradient was 8 mmHg. Both coronary ostia were patent. New mild to moderate mitral regurgitation occurred due to impingement of the anterior mitral leaflet by the first PHV. NYHA functional class improved from IV to II, maintained over the past 3 years. Echocardiography at 3 years showed normal functioning CoreValve-in-CoreValve prostheses, without AR or paravalvular leaks. Transvalvular gradient was 10 mmHg. Cardiac CT showed stable valve-in-valve protheses with no migration. CONCLUSION: The CoreValve prosthesis has maintained proper function up to 3 years, with no structural deterioration or migration. Treating mixed aortic valve disease with predominant AR is feasible. The concept as well as durability of the first PHV-in-PHV has also been demonstrated.

Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study.

BACKGROUND: The morbidity and mortality of surgical aortic valve replacement are increased in elderly patients with multiple high-risk comorbid conditions. Therefore, a prospective, single-center, nonrandomized study was performed in high-risk patients with aortic valve disease to evaluate the feasibility and safety of percutaneous implantation of a novel self-expanding aortic valve bioprosthesis (CoreValve). METHODS AND RESULTS: Symptomatic high-risk patients with an aortic valve area <1 cm2 were considered for enrollment. CoreValve implantation was performed under general anesthesia with extracorporeal support using the retrograde approach. Clinical follow-up and transthoracic echocardiography were performed after the procedure and at days 15 and 30 after device implantation to evaluate short-term patient and device outcomes. A total of 25 patients with symptomatic aortic valve stenosis (mean gradient before implantation, 44.2+/-10.8 mm Hg) and multiple comorbidities (median logistic EuroScore, 11.0%) were enrolled. Device success and procedural success were achieved in 22 (88%) and 21 (84%) patients, respectively. Successful device implantation resulted in a marked reduction in the aortic valve gradients (mean gradient after implantation, 12.4+/-3.0 mm Hg; P<0.0001). The mean aortic regurgitation grade was unchanged. Major in-hospital cardiovascular and cerebral events occurred in 8 patients (32%), including mortality in 5 patients (20%). Among 18 patients with device success surviving to discharge, no adverse events occurred within 30 days after leaving the hospital. CONCLUSIONS: Percutaneous implantation of the self-expanding CoreValve aortic valve prosthesis in high-risk patients with aortic stenosis with or without aortic regurgitation is feasible and, when successful, results in marked hemodynamic and clinical improvement.

First report on a human percutaneous transluminal implantation of a self-expanding valve prosthesis for interventional treatment of aortic valve stenosis.

BACKGROUND: Percutaneous aortic valve replacement is a new technology for the treatment of patients with significant aortic valve stenosis. We present the first report on a human implantation of a self-expanding aortic valve prosthesis, which is composed of three bovine pericardial leaflets inserted within a self-expanding nitinol stent. The 73-year-old woman presented with severe symptomatic aortic valve stenosis (mean transvalvular gradient of 45 mmHg; valve area of 0.7 cm2). Surgical valve replacement had been declined for the patient because of comorbidities, including previous bypass surgery. METHOD AND RESULTS: A retrograde approach via the common iliac artery was used for valve deployment. The contralateral femoral vessels were used for a temporary extracorporal circulation, unloading the left ventricle during the actual stent expansion. Clinical, hemodynamic, and echocardiographic outcomes were assessed serially during the procedure. Clinical and echocardiographic follow-up at day 1, 2, and 14 post procedure was performed to evaluate the short-term outcome. The prosthesis was successfully deployed within the native aortic valve, with accurate and stable positioning and with no impairment of the coronary artery or vein graft blood flow. 2D and doppler echo immediately after device deployment showed a significant reduction in transaortic mean pressure gradient (from 45 to 8 mmHg) without evidence of aortic or mitral valve insufficiency. The clinical status has then significantly improved. These results remained unchanged up to the day 14 follow-up. CONCLUSION: This case report demonstrates a successful percutaneous implantation of a self-expanding aortic valve prosthesis with remarkable functional and clinical improvements in the acute and short-term outcome.