Trans-catheter aortic valve implantation with the direct flow medical prosthesis: Single center short-term clinical and echocardiographic outcomes.

To analyze our single center experience with the Direct Flow Medical (DFM). The DFM has been recently introduced to the market and large real world experiences are lacking. A total of 126 patients with severe aortic valve stenosis (AVS) were treated by the same team from March 2013 to May 2015. Device success and procedural safety were classified, according to valve academic research consortium (VARC) criteria, for the entire cohort, including patients treated in the early phases of our learning curve. Clinical and trans-thoracic echocardiography follow-up was performed (median duration 279 days; 36-761 days). Mean age was 80.9 ± 5.5 years and median logistic Euro-SCORE was 15.9 (5.5-84.2). Cardiovascular 30-day mortality was 4.8% (6/126), device success 89.6% (113/126), and early safety 85.7% (108/126). At discharge, no aortic regurgitation (AR) was present in 85.7% and mild AR in 14.3% of the patients. Estimated 1-year follow-up survival was 91%. At follow-up, no AR was present in 87.3%, mild AR in 10.9%, and moderate AR in 1.8%. Mean gradient of 15.1 ± 6.3 mm Hg and prosthesis effective orifice area of 1.6 ± 0.6 cm2 were reported. In this single center experience, the DFM valve showed satisfactory clinical and hemodynamic results. Short-term follow-up confirmed the consistent clinical results, with low rates of AR and acceptable trans-prosthetic gradients and prosthetic effective orifice area. © 2016 Wiley Periodicals, Inc.

Kische S ，D'Ancona G ，Agma HU ，El-Achkar G ，Dißmann M ，Ortak J ，Ince H ... -  《-》

Transcatheter aortic valve implantation with the direct flow medical prosthesis: Impact of native aortic valve calcification degree on outcomes.

We present our single center experience with the direct flow medical (DFM) prosthesis addressing the impact of native aortic valve (AV) calcification degree on outcomes. The DFM® has been introduced for transcatheter aortic valve implantation (TAVI). The valve has a nonmetallic and inflatable support structure. Patients were divided in two groups according to preoperative cardiac computed tomography (CT): group I moderate calcification and group II heavy calcification of the total AV area. We evaluated 118 patients: 53 (45%) group I and 65 (55%) group II. Preoperative trans-AV gradient and calcification extension across the aortic unit were significantly higher in group II (P = 0.008 and P < 0.0001). CT perimeter derived annular diameter (group I 24.7 ± 2.1 mm vs. group II 24.8 ± 1.9; P = 0.6) and implanted prosthesis size (group I 26.1 ± 1.5 mm vs. group II 25.7 ± 1.5; P = 0.1) were similar. Hemodynamics were similar: mean gradient 16.1 ± 5.9 mm Hg (group I) vs. 17.3 ± 6.5 mm Hg (group II) (P = 0.3). Total aortic regurgitation (AR) was mild in 5.7% in group I and 20% in group II (P = 0.03). None developed moderate/severe AR. Heavy AV calcification was the sole independent determinant for mild regurgitation (P = 0.02; OR = 7; 95% CI: 1.2-37.6). Follow-up (289 days; 40-760 days) estimated survival was 88.1% (group I) and 93.8% (group II) (P = 0.3). Independent of AV calcification degree, adequate sizing and implantation can be achieved with the DFM®. Although higher burden of calcification increases the rate of mild AR, no patient developed moderate and severe AR. Short-term estimated survival was not influenced by calcification degree. © 2016 Wiley Periodicals, Inc.

D'Ancona G ，Agma HU ，Ince H ，El-Achkar G ，Dißmann M ，Ortak J ，Kische S ... -  《-》

Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve System: 12-Month Outcomes of the Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis

The aim of this study was to assess the 1-year outcome after transcatheter aortic valve replacement (TAVR) of the Direct Flow Medical (DFM) valve in patients with severe symptomatic aortic stenosis who were contraindicated or high risk for surgery. The DFM transcatheter heart valve is a new-generation, nonmetallic aortic valve with a pressurized support structure and conformable double-ring annular sealing delivered through an 18-F sheath. The device allows repositioning, retrieval, and assessment of valve performance before permanent implantation. A prospective multicenter European registry was set up to determine the safety and performance of the valve in 100 consecutive patients (10 centers). Echocardiographic and angiographic data were evaluated by an independent core laboratory, and adverse events were adjudicated by a clinical events committee using Valve Academic Research Consortium criteria. Patients were 83.1 ± 5.9 years of age and had a logistic EuroSCORE of 22.5 ± 11.3% and a Society of Thoracic Surgeons score of 9.7 ± 8.7%. Correct valve positioning was obtained in 99% of cases with a combined 30-day safety endpoint at 10%, including major stroke in 5.0%, major vascular complications in 2.0%, and death in 1%. At 12 months, 95% of patients were in New York Heart Association functional class I or II. Freedom from any death was 90%, and freedom from any death or major stroke was 85%. Echocardiography demonstrated none/trace to mild aortic regurgitation in 100% of patients and an unchanged mean aortic gradient of 12.2 ± 6.6 mm Hg and effective orifice area of 1.6 ± 0.4 cm(2). At 1 year, the DFM transcatheter heart valve had durable hemodynamics. This study demonstrates that the low rate of early complications and the low risk of significant aortic regurgitation translated into midterm clinical benefit.

Lefèvre T ，Colombo A ，Tchétché D ，Latib A ，Klugmann S ，Fajadet J ，De Marco F ，Maisano F ，Bruschi G ，Bijuklic K ，Nava S ，Weissman N ，Low R ，Thomas M ，Young C ，Redwood S ，Mullen M ，Yap J ，Grube E ，Nickenig G ，Sinning JM ，Hauptmann KE ，Friedrich I ，Lauterbach M ，Schmoeckel M ，Davidson C ，Schofer J ... -  《-》

Propensity-matched comparison between Direct Flow Medical, Medtronic Corevalve, and Edwards Sapien XT prostheses: Device success, thirty-day safety, and mortality.

To compare 30-day performance of three different type of transcatheter aortic valve implantation (TAVI) prosthesis: Direct Flow Medical (DFM), Medtronic Corevalve (MCV), and Edwards Sapien XT (ES). Forty consecutive patients treated with DFM for severe aortic stenosis were matched to an equal sample of patients undergoing TAVI with MCV and ES (1:1:1 propensity score-matching). Primary end-point was 30-day safety, defined according to the valve academic research consortium (VARC-2) criteria. Secondary end-points were: (i) immediate post-TAVI transaortic gradient reduction, (ii) device success, and (iii) 30-day mortality. Patients treated with DFM had higher 30-day safety rate compared to MCV and ES (respectively: 95.0% vs. 67.5% vs. 82.5%; P=0.006). Immediate post-TAVI, transaortic gradient reduction was similar for DFM, MCV, and ES subgroups (respectively: 8.3 ± 5.2 mm Hg vs. 5.3 ± 3.7 mm Hg vs. 5.6 ± 5.1 mm Hg; P=0.15); likewise, device success did not differ significantly (respectively: 100% vs. 92.5% vs. 92.5%; P=0.19). Mortality rates were also similar (respectively: 0% vs. 7.5% vs. 7.5%; P=0.190). In the pooled binary logistic regression analysis, blood transfusion was associated to 30-day safety (HR 0.156, 95% CI 0.049-0.500, P=0.002), while a significant trend was observed for the vascular closure device type (favoring Proglide vs. Prostar: HR 0.239, 95% CI 0.049-1.160, P=0.076). In high-risk patients with aortic stenosis undergoing TAVI, device success and short-term mortality were comparable between DFM, MCV, and ES. In contrast, the 30-day VARC-defined safety primary end-point was met significantly more frequently in patients treated with DFM. This result was mainly driven by differences in major vascular complications, associated to differences in vascular closure devices between the different valve subgroups.

Zhang Y ，Pyxaras SA ，Wolf A ，Schmitz T ，Naber CK ... -  《-》

Patient-prosthesis mismatch after transapical aortic valve implantation: incidence and impact on survival.

Transcatheter aortic valve implantation (TAVI) has become an important therapeutic option for high-risk patients with severe aortic valve stenosis. Patient-prosthesis mismatch (P-PM) is an important determinant of morbidity and mortality after open aortic valve replacement. The objective of our study was to evaluate P-PM incidence and its impact on survival in a large cohort of patients treated with TAVI. We retrospectively analyzed transesophageal echocardiographic data of 278 consecutive patients (Society of Thoracic Surgeons score 18.5 ± 15.3, age 80 ± 8 years) who underwent transapical TAVI with Edwards Sapien valves between April 2008 and March 2011. Effective orifice area was calculated using the continuity equation and indexed with body surface area (iEOA). P-PM was stratified as severe (iEOA < 0.65 cm(2)/cm(2)) and moderate (iEOA, 0.65-0.85 cm(2)/m(2)). Midterm survival (up to 30 months) was analyzed by Kaplan-Meier curves and log-rank tests. There was no P-PM in 181 (65.1%) patients; moderate P-PM was found in 76 (27.3%) patients and severe P-PM in 21 (7.6%). Thirty-day survival was 96.0%, 97.3%, and 90.5%. The 3-month survival was 91%, 90%, and 66%, respectively (P = .0013). Combination of severe P-PM with peak pressure gradients greater than 10 mm Hg further reduced the 3-month survival to 48%. Additionally, mean survival time in patients with an ejection fraction less than 50% was significantly shorter than in patients with an ejection fraction greater than 50% (20.8 ± 1.5 vs 24.1 ± 0.8 months; P = .027). P-PM is found in patients undergoing transapical TAVI. Severe mismatch is accompanied by high early mortality, especially when combined with increased pressure gradients.

Kukucka M ，Pasic M ，Dreysse S ，Mladenow A ，Habazettl H ，Hetzer R ，Unbehaun A ... -  《-》