Single-Center Experience and Short-term Outcome with the JenaValve: A Second-Generation Transapical Transcatheter Aortic Valve Implantation Device

2014 ◽  
Vol 9 (5) ◽  
pp. 368-374 ◽  
Author(s):  
Oliver Reuthebuch ◽  
Devdas Thomas Inderbitzin ◽  
Florian Ruter ◽  
Raban Jeger ◽  
Christoph Kaiser ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Second Generation ◽  
Short Term ◽  
Term Outcome ◽  
Transcatheter Aortic Valve ◽  
Short Term Outcome ◽  
The Mean ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Objective We present the post-CE(Conformité Européenne)-mark single-center implantation experience and short-term outcome with the second-generation transapical JenaValve transcatheter aortic valve implantation system. Methods Patients [N = 27; 9 women; mean (SD) age, 80.3 (5.5) years] were operated on between November 2011 and August 2012. Via a transapical approach, the valve was positioned, in some cases, repositioned, and finally implanted. All data were collected during the hospital stay. Results The implantation success rate was 100%; the mean (SD) operation time was 124.7 (43.2) minutes; and the size of the implanted prosthesis was 23 mm (n = 6), 25 mm (n = 14), and 27 mm (n = 7). The in-hospital major adverse cardiac and cerebrovascular events were as follows: intraoperative resuscitation with subsequent aortic rupture (n = 1), postoperative hemorrhage needing revision (n = 1), myocardial infarction (n = 1), atrioventricular block needing a definitive pacemaker (n = 1), new-onset renal failure needing hemodialysis (n = 1), and stroke (n = 1). The 30-day mortality was 11.1% (n = 3). The mean (SD) intensive care unit/total stay was 2.2 (1.7)/11.7 (7.9) days. Postoperative echocardiography [day 6.7 (4.8)] revealed residual para-valvular leakage of trace to grade 1 in 12 patients (44.5%) and no leakage in 15 patients, with a mean (SD) transvalvular pressure gradient of 11.6 (5.6) mm Hg with significant reduction by 36.0 (17.7) mm Hg ( P = 0.0001, Wilcoxon signed rank test). Conclusions This second-generation repositionable transcatheter aortic valve implantation device could safely and successfully be implanted with a fast learning curve, significant reduction in pressure gradients, overall clinical improvement at discharge, as well as an acceptable morbidity and mortality rate in this highest-risk patient cohort.

scholarly journals Balloon-expandable transfemoral transcatheter aortic valve implantation with or without predilation: findings from the prospective EASE-IT TF multicentre registry

Open Heart ◽  
2019 ◽  
Vol 6 (2) ◽  
pp. e001082 ◽  
Author(s):  
Gerhard Schymik ◽  
Tanja Rudolph ◽  
Claudius Jacobshagen ◽  
Jürgen Rothe ◽  
Hendrik Treede ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Academic Research ◽  
Short Term ◽  
Native Valve ◽  
Transcatheter Aortic Valve ◽  
Registration Number ◽  
The Mean ◽  
Aortic Valve Implantation ◽  
Valve Implantation

BackgroundPredilation of the native valve has long been deemed necessary in transfemoral transcatheter aortic valve implantation (TF-TAVI), despite little trial evidence to support its clinical use. As most evidence is derived from retrospective analyses of observational studies, we conducted a two-armed, prospective multicentre registry.MethodsPatients undergoing TF-TAVI with the Edwards SAPIEN 3 valve, with or without balloon aortic valvuloplasty (BAV), were included and their procedural characteristics, short-term safety and short-term efficacy outcomes compared. We hypothesised that BAV may be safely omitted in many patients and omission could be associated with procedural benefits.ResultsOverall, 196 consecutive patients underwent TF-TAVI, 56 with BAV and 140 without. The mean age was 81.2±6.2 years, and the mean logistic EuroSCORE I was 17.1±13.6. Device success according to Valve Academic Research Consortium-2 (VARC-2) was achieved in 96.4%. The median procedural duration was shorter without BAV (56 min vs 90 min; p=0.001), as was fluoroscopy time (10 min vs 13 min; p=0.001). The need for balloon postdilation was less frequent in patients without BAV (15.7% vs 30.4%, p=0.029). There was no difference in the proportion of patients meeting the VARC-2 defined composite safety endpoint at 30 days (9.3% without vs 8.9% with BAV; adjusted OR (adjOR) 2.55; 95% CI 0.56 to 18.84) and at 6 months (15.2% without vs 16.4% with BAV; adjOR 1.66; 95% CI 0.49 to 6.55).ConclusionsIn the majority of patients, BAV can be safely omitted from the TAVI procedure without adverse effects. The omission of BAV is associated with shorter procedural duration and could be advantageous for the majority of patients.Trial registration numberNCT02760771.

Kidney dysfunction and short term all-cause mortality after transcatheter aortic valve implantation

2020 ◽  
Vol 81 ◽  
pp. 32-37 ◽  
Author(s):  
Fabio Alfredo Sgura ◽  
Salvatore Arrotti ◽  
Paolo Magnavacchi ◽  
Daniel Monopoli ◽  
Davide Gabbieri ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Kidney Dysfunction ◽  
Short Term ◽  
Transcatheter Aortic Valve ◽  
All Cause Mortality ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Midterm Outcomes after Transcatheter Aortic Valve Implantation

2014 ◽  
Vol 9 (5) ◽  
pp. 343-348 ◽  
Author(s):  
Shahram Lotfi ◽  
Guido Dohmen ◽  
Andreas Götzenich ◽  
Marcus Haushofer ◽  
Jan Wilhelm Spillner ◽  
...  
Keyword(s):  
High Risk ◽  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Pacemaker Implantation ◽  
Logistic Euroscore ◽  
Transcatheter Aortic Valve ◽  
Significant Difference ◽  
The Mean ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Objective Transcatheter aortic valve implantation (TAVI) has become a therapeutic option for high-risk or nonoperable patients with severe symptomatic aortic valve stenosis. The best known and most frequently implanted prostheses are the CoreValve and SAPIEN prostheses. We report our experiences and analyze the results of our TAVI program. Methods A total of 357 patients underwent transfemoral (TF) and transapical (TA) TAVI in our center between January 2008 and October 2012. The procedure was performed in 190 patients with CoreValve, in 155 patients with SAPIEN, and in 12 patients with ACURATE TA prostheses. Transfemoral access was used in 190 patients. In 167 patients, TA access was used. The mean age was 80.2 ± 6.4 years. All patients were nonoperable or had a high risk for a conventional aortic valve replacement. The mean logistic EuroSCORE I was 25.92 ± 14.51%. The TF/CoreValve (190 patients) and TA/SAPIEN (155 patients) groups showed significant difference in the patients’ mean age (81.7 ± 6.3 years vs. 79.5 ± 6.6 years, P = 0.002) and in mean logistic EuroSCORE I (22.16 ± 13.05% vs. 31.04 ± 16.40, P < 0.001). Results The overall 30-day mortality (357 patients) was 9.80% (TF, 8.42%; TA, 11.37%); overall 1-year mortality (275 patients), 21.45% (TF, 23.74%; TA, 19.12%); overall 2-year mortality (199 patients), 29.15% (TF, 35.96%; TA, 23.64%); overall 3-year mortality (133 patients), 37.59% (TF, 43.86%; TA, 32.89%); and overall 4-year mortality (38 patients), 39.47% (TF, 45%; TA, 33.33%). The rate of pacemaker implantation after TAVI was significantly higher in the CoreValve group than in the SAPIEN group: 44.74% (85/190 patients) versus 6.45% (10/155 patients), P < 0.001. Stroke rate was higher in the TF-CoreValve group than in the TA-SAPIEN group: 4.21% versus 0.64%, P = 0.045. Conclusions Outcomes after TAVI were, in our population of nonoperable and high-risk patients, encouraging. The differences in midterm outcomes between the TF-CoreValve TAVI and the TA-SAPIEN TAVI were not significant.

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