Dataset Information

Evolution of transcatheter aortic valve implantation over 7 years: results of a prospective single-centre registry of 2000 patients in a large municipal hospital (TAVIK Registry).

ABSTRACT:

Objectives

Use of transcatheter aortic valve implantation (TAVI) to treat severe aortic stenosis (AS) has gained popularity, accompanied by an evolution of patient and clinical factors. We aimed to characterise changes and evaluate their impact on outcomes.

Setting

In this single-centre, German TAVIK registry patients undergoing TAVI between 2008 and 2015 were documented prospectively.

Participants/interventions

2000 consecutive patients with AS undergoing TAVI were divided in four cohorts. 500 patients underwent TAVI in each of the following time bins: April 2008 to July 2010 (cohort I), July 2010 to April 2013 (cohort II), April 2012 to October 2013 (cohort III) and October 2013 to March 2015 (cohort IV).

Results

The mean age was 81.8 years, without significant variation across cohorts. Compared with cohort I, prior MI (5.4%vs11.0%; p<0.001) and New York Heart Association class IV (10.0%vs3.6%; p<0.001) were less common in cohort IV. Across cohorts, there was a fall in EuroSCORE (24.3%-18.7%), frailty (48.4%-17.0%) and use of transapical access (43.6%-29.0%), while transfemoral access increased (56.4%-71.0%; p<0.001 for each). Periprocedurally, there was a fall in moderate/severe aortic regurgitation (3.2%-0.0%) and rate of unplanned cardiopulmonary bypass (4.0%-1.0%; both p<0.001). A similar trend applied to 30-day rate of major vascular complications (5.2%-1.8%; p=0.006), life-threatening bleeding (7.0%-3.0%; p<0.001) and cardiovascular mortality (4.4%-1.8%; p=0.020). One-year post-TAVI, mortality and stroke rates did not differ.

Conclusions

Evolution of TAVI between 2008 and 2015 saw a trend towards its usage in lower risk patients and rapid progression towards improved safety. Evaluation and refinement should now continue to further lessen stroke and pacemaker rates.

SUBMITTER: Schymik G

PROVIDER: S-EPMC6224754 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Publications

Evolution of transcatheter aortic valve implantation over 7 years: results of a prospective single-centre registry of 2000 patients in a large municipal hospital (TAVIK Registry).

Schymik Gerhard G Herzberger Valentin V Bergmann Jens J Bramlage Peter P Conzelmann Lars O LO Würth Alexander A Luik Armin A Schröfel Holger H Tzamalis Panagiotis P

BMJ open 20181025 10

<h4>Objectives</h4>Use of transcatheter aortic valve implantation (TAVI) to treat severe aortic stenosis (AS) has gained popularity, accompanied by an evolution of patient and clinical factors. We aimed to characterise changes and evaluate their impact on outcomes.<h4>Setting</h4>In this single-centre, German TAVIK registry patients undergoing TAVI between 2008 and 2015 were documented prospectively.<h4>Participants/interventions</h4>2000 consecutive patients with AS undergoing TAVI were divided ...[more]

PMID: 30366914

Similar Datasets

Project description:ObjectiveTranscatheter aortic valve implantation (TAVI) procedures are increasing rapidly, but the durability of tissue valve and periprocedural complications are not satisfactory. Immune reaction to the galactose-α-1,3 galactose β-1,4-N-acetylglucosamine (α-Gal) and conventional processing protocols of cardiac xenografts lead to calcification. Next-generation TAVI needs to be made with α-Gal-free xenografts by multiple anticalcification therapies to avoid immune rejection and enhance durability, and three-dimensional (3D) printing technology to improve the procedural safety.MethodsPorcine pericardia were decellularized and immunologically modified with α-galactosidase. The pericardia were treated by space filler, crosslinked with glutaraldehyde in organic solvent, and detoxified. The sheep-specific nitinol (nickel-titanium memory alloy) wire backbone was made from a 3D-printed model for ovine aortic root. After it passed the fitting test, we manufactured a self-expandable stented valve with the porcine pericardia mounted on the customized nitinol wire-based stent. After in vitro circulation using customized silicone aortic root, we performed TAVI in 9 sheep and obtained hemodynamic, radiological, immunohistopathological, and biochemical results.ResultsThe valve functioned well, with excellent stent fitting and good coronary flow under in vitro circulation. Sheep were sequentially scheduled to be humanely killed until 238 days after TAVI. Echocardiography and cardiac catheterization demonstrated good hemodynamic status and function of the aortic valve. The xenografts were well preserved without α-Gal immune reaction or calcification based on the immunological, radiographic, microscopic, and biochemical examinations.ConclusionsWe proved preclinical safety and efficacy for next-generation α-Gal-free TAVI with multiple anticalcification therapies and 3D-printing technology. A future clinical study is warranted based on these promising preclinical results.

Dataset Information

Evolution of transcatheter aortic valve implantation over 7 years: results of a prospective single-centre registry of 2000 patients in a large municipal hospital (TAVIK Registry).

Objectives

Setting

Participants/interventions

Results

Conclusions

Publications

Evolution of transcatheter aortic valve implantation over 7 years: results of a prospective single-centre registry of 2000 patients in a large municipal hospital (TAVIK Registry).

Similar Datasets

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