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Trends and Outcomes of Transcatheter Aortic Valve Implantation (TAVI) in Korea: the Results of the First Cohort of Korean TAVI Registry.

ABSTRACT: BACKGROUND AND OBJECTIVES:There has been no nation-wide data on the outcomes of transcatheter aortic valve implantation (TAVI) after commercialization of TAVI in Korea. We report clinical features and outcomes of the first cohort of TAVI performed from Jun 2015 to Jun 2017 in Korea. METHODS:The first cohort of Korean-TAVI (K-TAVI) registry includes 576 consecutive patients with severe symptomatic aortic stenosis who underwent TAVI from 17 Korean hospitals for 2 years. RESULTS:Most of TAVI procedures were performed for septuagenarians and octogenarians (90.8%) through transfemoral approach (98.3%). The rate of device success was 92.5% and permanent pacemaker was implanted in 5.6%. In successive years, incidences of paravalvular leakage (PVL) and major bleeding declined. Society of Thoracic Surgeons (STS) score was 5.2 (3.0 to 9.0) and 34.7% of patients had high surgical risk (STS ?8). One-year all-cause death occurred in 8.9% and was significantly lower in low to intermediate risk one than in high risk (5.4% vs. 15.5%, p<0.001). The independent predictors of 1-year mortality were age (hazard ratio [HR], 1.087; 95% confidence interval [CI], 1.036-1.141; p=0.001), moderate or severe PVL (HR, 4.631; 95% CI, 1.624-13.203; p=0.004) and end-stage renal disease (HR, 5.785; 95% CI, 2.717-12.316; p<0.001). CONCLUSIONS:K-TAVI registry showed favorable 1-year outcomes with decreasing complication rate over time in real-world Korean patients. Two-thirds of patients were low to intermediate surgical risk and showed a significantly lower mortality than the high-risk patients, suggesting the promising future on the expanded indications of TAVI.

SUBMITTER: Yu CW

PROVIDER: S-EPMC5940643 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Trends and Outcomes of Transcatheter Aortic Valve Implantation (TAVI) in Korea: the Results of the First Cohort of Korean TAVI Registry.

Yu Cheol Woong CW Kim Won Jang WJ Ahn Jung Min JM Kook Hyungdon H Kang Se Hun SH Han Jung Kyu JK Ko Young Guk YG Choi Seung Hyuk SH Koo Bon Kwon BK Chang Kiyuk K Kim Hyo Soo HS

Korean circulation journal 20180417 5

<h4>Background and objectives</h4>There has been no nation-wide data on the outcomes of transcatheter aortic valve implantation (TAVI) after commercialization of TAVI in Korea. We report clinical features and outcomes of the first cohort of TAVI performed from Jun 2015 to Jun 2017 in Korea.<h4>Methods</h4>The first cohort of Korean-TAVI (K-TAVI) registry includes 576 consecutive patients with severe symptomatic aortic stenosis who underwent TAVI from 17 Korean hospitals for 2 years.<h4>Results</ ...[more]

PMID: 29671283

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Project description:BackgroundIn the treatment of valvular heart diseases, transcatheter therapies have changed the rules of the game, especially in the case of aortic stenosis and mitral regurgitation. Since the first in man transcatheter aortic valve intervention (TAVI) performed by Dr. Alain Cribier in 2002 in a non-operable aortic stenosis (AS) patient, TAVI has changed the lives of so many patients for whom medical treatment was, up to then, the only option.ObjectiveThis article outlines patient selection and pre-procedure evaluation, current perspectives, recent advances, current and future devices, current guidelines informing the use of TAVI, expanding indications for TAVI, ongoing challenges and the future of TAVI.MethodsThe use of these percutaneous techniques has also increased significantly in the past few years with its first application in 2002, transcatheter aortic valve implantation (TAVI) has revolutionized the management of aortic stenosis and has become the standard of care for patients with AS at prohibitively high surgical risks, as well as a preferred treatment for elderly patients with intermediate and high-risk AS.ResultsSince the first pioneering procedure was performed 22 years ago, transcatheter aortic valve implantation (TAVI) has evolved into a routine procedure increasingly performed under conscious sedation via transfemoral access. On a global market worth $2 billion per year, over 300 000 patients have received a transcatheter aortic valve, demonstrating its clinical and market impact. TAVI may be used in lower risk, younger, asymptomatic populations with ongoing studies using an expanding portfolio of devices. Also, for patients deemed unsuitable for cardiac surgery, mitral transcatheter therapies represent the treatment of choice. Percutaneous repair techniques have had the most clinical experience to date.ConclusionDuring this 20-year period, the increased knowledge on pre-procedural planning, the important technological improvements in transcatheter valves, the increased experience and the numerous studies that have been carried out have permitted an expansion of the indications for TAVI, from inoperable patients to high- and intermediate-risk patients. This article outlines patient selection and pre-procedure evaluation, current perspectives, recent advances, current and future devices, current guidelines informing the use of TAVI, expanding indications for TAVI, ongoing challenges and the future of TAVI.

Project description:There is an increasing trend towards shorter hospital stays after transcatheter aortic valve implantation (TAVI), in particular for patients undergoing the procedure via transfemoral (TF) access. Preliminary data suggest that there exists a population of patients that can be discharged safely very early after TF-TAVI. However, current evidence is limited to few retrospective studies, encompassing relatively small sample sizes.The Feasibility And Safety of early discharge after Transfemoral TAVI (FAST-TAVI) registry is a prospective observational registry that will be conducted at 10 sites across Italy, the Netherlands and the UK. Patients will be included if they have been scheduled to undergo TF-TAVI with the balloon-expandable SAPIEN 3 transcatheter heart valve (THV; Edwards Lifesciences, Irvine, CA). The primary endpoint is a composite of all-cause mortality, vascular-access-related complications, permanent pacemaker implantation, stroke, re-hospitalisation due to cardiac reasons, kidney failure and major bleeding, occurring during the first 30 days after hospital discharge. Patients will be stratified according to whether they were high or low risk for early discharge (?3 days) (following pre-specified criteria), and according to whether or not they were discharged early. Secondary endpoints will include time-to-event (Kaplan-Meier) analysis for the primary outcome and its individual components, analysis of the relative costs of early and late discharge, and changes in short- and long-term quality of life. Multivariate logistic regression will be used to identify factors that indicate that a patient may be suitable for early discharge.The data gathered in the FAST-TAVI registry should help to clarify the safety of early discharge after TF-TAVI and to identify patient and procedural characteristics that make early discharge from hospital a safe and cost-effective strategy.ClinicalTrials.gov Identifier: NCT02404467 (registration first received March 23rd 2015).

Dataset Information

Trends and Outcomes of Transcatheter Aortic Valve Implantation (TAVI) in Korea: the Results of the First Cohort of Korean TAVI Registry.

Publications

Trends and Outcomes of Transcatheter Aortic Valve Implantation (TAVI) in Korea: the Results of the First Cohort of Korean TAVI Registry.

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