Impact of aortic valve calcification on the outcome of transcatheter aortic valve implantation: results from the prospective multicenter German TAVI registry.

Transcatheter aortic valve implantation (TAVI) is an emerging technology in patients with severe aortic stenosis. Whether the degree of aortic valve calcification impacts the outcome after TAVI has not been thoroughly evaluated. We analyzed data from the prospective multicenter German TAVI registry, including 1,365 patients as of July 2010. Patients were divided into three groups, based on the degree of aortic valve calcification: mild (n = 67), moderate (n = 392), and severe (n = 906) valve calcification, determined by visual estimation by the operator. Mean age was 81.7 ± 6.2 years; mean logistic EUROscore was 20.6 ± 13.7%. Patients with severe aortic valve calcification had a higher mean and peak-to-peak gradient before the intervention (P < 0.0001). Technical success was achieved in 97%, similar in each group. The Medtronic CoreValve was implanted in 80.8%, the Sapien Edwards prosthesis in the remaining cases. The duration of the procedure and fluoroscopy was higher in the group with severe calcification (P < 0.01 for procedure and P < 0.05 for fluoroscopy). During the periprocedural period there were no differences among the groups regarding in-hospital death, cerebrovascular events, myocardial infarction, thromboembolic events, aortic dissection, or severe vascular complications. Furthermore, there was no significant difference in postprocedural aortic mean gradient (7.0 mm Hg vs. 5.6 mm Hg vs. 6.3 mm Hg; P = 0.07), in residual aortic regurgitation (74% vs. 72% vs. 68%; P = 0.3) or postprocedure pacemaker implantation (38% vs. 30.4% vs. 34.2%; P = 0.35). During 30-day follow up there was no difference in regard to the number of death, strokes, and myocardial infarctions. Our results of a real-world registry suggest that the extent of aortic valve calcification does not influence the success or procedural outcome significantly.

Staubach S ，Franke J ，Gerckens U ，Schuler G ，Zahn R ，Eggebrecht H ，Hambrecht R ，Sack S ，Richardt G ，Horack M ，Senges J ，Steinberg DH ，Ledwoch J ，Fichtlscherer S ，Doss M ，Wunderlich N ，Sievert H ，German Transcatheter Aortic Valve Implantation-Registry Investigators ... -  《-》

Transcatheter aortic valve implantation without balloon predilation: a single-center pilot experience.

To assess the results of transcatheter aortic valve implantation (TAVI) using the Medtronic CoreValve prosthesis (Medtronic, Minneapolis, MN), without balloon predilation, in high-risk patients with degenerated severe aortic stenosis. Fifty-one consecutive patients who underwent direct TAVI, 98% through a transfemoral approach. Patients were 79 ± 8 years of age, 74% in New York Heart Association classes III or IV and at high risk for surgical valve replacement (mean logistic EuroScore 20 ± 15). Mean aortic valve area was 0.7 ± 0.2 cm(2). Procedural success rate was 94.2%. In-hospital, there were 2 deaths, 1 minor stroke with minimal sequelae, and 14 (28%) pacemaker implantation. At 30 days, there was one additional stroke and no new deaths. The mean postprocedural transprosthetic gradient was 15 ± 5 mm Hg; periprosthetic severe regurgitation was absent and moderate in one case. After a median follow-up of 7 months, there were five additional deaths (two cardiac), while 84% of survivors were in New York Heart Association classes I or II. These results suggest that direct CoreValve implantation in patients with severe aortic stenosis is feasible and may lead to hemodynamic and clinical improvement in patients who are poor candidates for aortic valve surgery, pending confirmation in larger series with longer follow-up.

Mendiz OA ，Fraguas H ，Lev GA ，Valdivieso LR ，Favaloro RR ... -  《-》

Incidence and predictors of permanent pacemaker implantation following transcatheter aortic valve implantation: analysis from the German transcatheter aortic valve interventions registry.

To determine predictors of permanent pacemaker (PPM) implantation up to 30 days after transcatheter aortic valve implantation (TAVI) in a prospective multicenter registry. Conduction disorders requiring PPM implantation are one of the most common complications seen after TAVI. Knowledge about possible predictors may help to decrease the rate of PPM implantations. In total, 1347 consecutive patients who underwent TAVI in 22 centers were prospectively enrolled in the German transcatheter aortic valve interventions registry. Both Medtronic CoreValve™ and Edwards Sapien™ valves were implanted. Patients with preprocedurally implanted PPM or implantable cardioverter defibrillator were excluded from the analysis (n = 199). Regression analysis of baseline and procedure characteristics of the remaining 1,147 patients was performed. Procedural success was achieved in 97.4% of the cases. The rate for PPM after TAVI was 33.7%. The absence of prior valve surgery, the use of Medtronic CoreValve™ prosthesis and the presence of a porcelain aorta were identified as independent predictors for PPM after TAVI. Mortality at 30 days did not differ between patients with or without PPM necessity (6.0% vs. 8.1%, respectively; HR 0.72; CI (0.45-1.16); P = 0.17). PPM is a common postprocedure requirement after TAVI. The absence of prior valve surgery, the implantation of Medtronic CoreValve™ prosthesis, and the presence of a porcelain aorta were independently associated with PPM after TAVI.

Ledwoch J ，Franke J ，Gerckens U ，Kuck KH ，Linke A ，Nickenig G ，Krülls-Münch J ，Vöhringer M ，Hambrecht R ，Erbel R ，Richardt G ，Horack M ，Zahn R ，Senges J ，Sievert H ，German Transcatheter Aortic Valve Interventions Registry Investigators ... -  《-》

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 ... -  《-》

Early clinical outcome of aortic transcatheter valve-in-valve implantation in the Nordic countries.

Transcatheter valve-in-valve implantation has emerged as an option, in addition to reoperative surgical aortic valve replacement, to treat failed biologic heart valve substitutes. However, the clinical experience with this approach is still limited. We report the comprehensive experience of transcatheter valve-in-valve implantation in the Nordic countries from May 2008 to January 2012. A total of 45 transcatheter aortic valve-in-valve implantations were performed during the study period in 11 centers. The mean age of the patients was 80.6 years (range, 61-91), 26 were male and 19 were female, and the mean EuroSCORE, EuroSCORE II, and Society of Thoracic Surgeons score was 35.4, 16.3, and 14.6, respectively. The type of failure was stenosis and combined in 58% (mean and peak aortic valve gradient, 77 and 45 mm Hg, respectively) and regurgitation in 42% of cases. The SAPIEN/XT (Edwards LifeSciences, Irvine, Calif) and CoreValve (Medtronic Inc, Minneapolis, Minn) system was used in 33 and 12 cases, respectively. The access route was transapical in 25, transfemoral in 17, transaortic in 2, and subclavian in 1 case. The mean follow-up was 14.4 months. The periprocedural and postoperative outcomes were assessed using the Valve Academic Research Consortium criteria. No intraprocedural mortality occurred. The technical success rate was 95.6% (1 second valve implantation, 1 conversion to open surgery). The all-cause 30-day mortality was 4.4% (1 cardiac-related and 1 aspiration pneumonia). The major complications within 30 days included stroke in 2.2%, periprocedural myocardial infarction in 4.4%, and major vascular complication in 2.2% of patients. At 1 month, all but 1 patient had either no or mild paravalvular leakage, with a mean and peak valve gradient of 17 mm Hg (range, 4-38) and 30 mm Hg (range, 7-68), respectively. The mean gradient was greater than 20 mm Hg in 17% of patients and remained unchanged at 12 months. The 1-year survival was 88.1%. Transcatheter valve-in-valve implantation is widely performed, albeit in small numbers, in most centers in the Nordic countries. The short-term results were excellent in this high-risk patient population, demonstrating a low incidence of device- or procedure-related complications. However, a considerable number of patients were left with suboptimal systolic valve performance with unknown long-term effects, warranting close surveillance after transcatheter valve-in-valve implantation.

Ihlberg L ，Nissen H ，Nielsen NE ，Rück A ，Busund R ，Klaarborg KE ，Soendergaard L ，Harnek J ，Miettinen H ，Eskola M ，Wahba A ，Laine M ... -  《-》