Midterm Outcomes after Transcatheter Aortic 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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Comparison of mid-term results of transcatheter aortic valve implantation in high-risk patients with logistic EuroSCORE ≥ 20% or < 20%

Kardiologia Polska ◽

10.5603/kp.a2015.0161 ◽

2015 ◽

pp. 224-230 ◽

Cited By ~ 1

Author(s):

Zbigniew Chmielak ◽

Adam Witkowski ◽

Maciej Dąbrowski ◽

Marcin Demkow ◽

Krzysztof Kuśmierski ◽

...

Keyword(s):

High Risk ◽

Aortic Valve ◽

Transcatheter Aortic Valve Implantation ◽

Logistic Euroscore ◽

High Risk Patients ◽

Transcatheter Aortic Valve ◽

Risk Patients ◽

Aortic Valve Implantation ◽

Valve Implantation ◽

Mid Term Results

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Prespecified Risk Criteria Facilitate Adequate Discharge and Long‐Term Outcomes After Transfemoral Transcatheter Aortic Valve Implantation

Journal of the American Heart Association ◽

10.1161/jaha.120.016990 ◽

2020 ◽

Vol 9 (15) ◽

Author(s):

Mark S. Spence ◽

Jan Baan ◽

Fortunato Iacovelli ◽

Gian Luca Martinelli ◽

Douglas F. Muir ◽

...

Keyword(s):

High Risk ◽

Aortic Valve ◽

Transcatheter Aortic Valve Implantation ◽

Event Rate ◽

Pacemaker Implantation ◽

Permanent Pacemaker ◽

Transcatheter Aortic Valve ◽

Aortic Valve Implantation ◽

Valve Implantation ◽

Transfemoral Tavi

Background Despite the availability of guidelines for the performance of transcatheter aortic valve implantation (TAVI), current treatment pathways vary between countries and institutions, which impact on the mean duration of postprocedure hospitalization. Methods and Results This was a prospective, multicenter registry of 502 patients to validate the appropriateness of discharge timing after transfemoral TAVI, using prespecified risk criteria from FAST‐TAVI (Feasibility and Safety of Early Discharge After Transfemoral [TF] Transcatheter Aortic Valve Implantation), based on hospital events within 1‐year after discharge. The end point—a composite of all‐cause mortality, vascular access–related complications, permanent pacemaker implantation, stroke, cardiac rehospitalization, kidney failure, and major bleeding—was reached in 27.0% of patients (95% CI, 23.3–31.2) within 1 year after intervention; 7.5% (95% CI, 5.5–10.2) had in‐hospital complications before discharge and 19.6% (95% CI, 16.3–23.4) within 1 year after discharge. Overall mortality within 1 year after discharge was 7.3% and rates of cardiac rehospitalization 13.5%, permanent pacemaker implantation 4.2%, any stroke 1.8%, vascular‐access–related complications 0.7%, life‐threatening bleeding 0.7%, and kidney failure 0.4%. Composite events within 1 year after discharge were observed in 18.8% and 24.3% of patients with low risk of complications/early (≤3 days) discharge and high risk and discharged late (>3 days) (concordant discharge), respectively. Event rate in patients with discordant discharge was 14.3% with low risk but discharged late and increased to 50.0% in patients with high risk but discharged in ≤3 days. Conclusions The FAST‐TAVI risk assessment provides a tool for appropriate, risk‐based discharge that was validated with the 1‐year event rate after transfemoral TAVI. Registration URL: https://www.ClinicalTrials.gov ; Unique identifier: NCT02404467.

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A Meta-Analysis of Transfemoral versus Transapical Transcatheter Aortic Valve Implantation on 30-Day and 1-Year Outcomes

The Heart Surgery Forum ◽

10.1532/hsf.1388 ◽

2015 ◽

Vol 18 (4) ◽

pp. 161 ◽

Cited By ~ 11

Author(s):

An Zhao ◽

Hu Minhui ◽

Xu Li ◽

Xu Zhiyun

Keyword(s):

Aortic Valve ◽

Transcatheter Aortic Valve Implantation ◽

Meta Analysis ◽

Vascular Complications ◽

Logistic Euroscore ◽

Transcatheter Aortic Valve ◽

Effect Model ◽

Significant Difference ◽

Aortic Valve Implantation ◽

Valve Implantation

Background: Transfemoral (TF) and transapical (TA) are two commonly used accesses in transcatheter aortic valve implantation (TAVI). Currently, the influence of TAVI access choice on 30-day and 1-year outcomes is unclear. The purpose of this study was to compare the 30-day and 1-year outcomes between TF-TAVI and TA-TAVI.<br />Methods: Studies published from 2002 to September 2014 were collected by searching PubMed and Web of Knowledge. Studies were selected by two independent investigators. 30-day and 1-year outcomes were endpoints. Odds ratios (ORs) and hazard ratio (HR) with 95% confidence interval (CI) were computed. Fixed effect model was used if I2 < 50%; if I2 > 50%, random effect model was used.<br />Results: 14 studies met inclusion criteria and were included in our analysis (3837 patients in TF group, 1881 patients in TA group). Two were retrospective trials and the others were prospective trials. Our meta-analysis showed that compared with TA group, TF group had a lower 30-day mortality (7.5% versus 11.6%) and higher 1-year survival [HR 0.75, 95% CI (0.66, 0.86)], but the Logistic EuroSCORE was higher in TA group (P = 0.00). TF group had a significantly higher stroke rate of 4.0% compared with 2.2% in TA group at ≤30 days. The incidence of major vascular complications was significantly higher in TF group compared with TA group (8.2% versus 5.3%). MI was more common in TA group (2.4%) compared with TF group (1.2%), but there were no significant difference [0.46, 95% CI (0.20, 1.06)].<br />Conclusions: TF-TAVI had a higher 30-day and 1-year survival rate compared with TA-TAVI, but these differences might be because of the higher Logistic EuroSCORE in TA group. Stroke and major vascular complications rates were higher in TF-TAVI patients at ≤30 days.

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The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes

Clinical Research in Cardiology ◽

10.1007/s00392-021-01882-3 ◽

2021 ◽

Author(s):

Helge Möllmann ◽

David M. Holzhey ◽

Michael Hilker ◽

Stefan Toggweiler ◽

Ulrich Schäfer ◽

...

Keyword(s):

Aortic Valve ◽

Transcatheter Aortic Valve Implantation ◽

Pacemaker Implantation ◽

Paravalvular Leak ◽

Transcatheter Aortic Valve ◽

All Cause Mortality ◽

Valve Thrombosis ◽

Aortic Valve Implantation ◽

And Performance ◽

Valve Implantation

Abstract Background Transcatheter aortic valve implantation (TAVI) has become standard treatment for elderly patients with symptomatic severe aortic valve stenosis. The ACURATE neo AS study evaluates 30-day and 1-year clinical and hemodynamic outcomes in patients treated with the ACURATE neo2 valve. Methods The primary endpoint of this single-arm multicenter study is 30-day all-cause mortality. Other key endpoints include device performance, echocardiographic measures assessed by an independent core laboratory, and VARC-2 clinical efficacy and safety endpoints through 12 months. Results The study enrolled 120 patients (mean age 82.1 ± 4.0 years; 67.5% female, mean baseline STS score 4.8 ± 3.8%). The VARC-2 composite safety endpoint at 30 days occurred in 13.3% of patients. All-cause mortality was 3.3% at 30 days and 11.9% at 1 year. The 30-day stroke rate was 2.5% (disabling stroke 1.7%); there were no new strokes between 30 days and 12 months. The rate of permanent pacemaker implantation was 15.0% (18/120) at 30 days and 17.8% (21/120) at 1 year. No patients required re-intervention for valve-related dysfunction and there were no cases of valve thrombosis or endocarditis. Patients demonstrated significant improvement in mean aortic valve gradient (baseline 38.9 ± 13.1 mmHg, 1 year 7.8 ± 3.5 mmHg; P < 0.001 in a paired analysis). In the overall population, paravalvular leak was evaluated at 1 year as none/trace in 60.5%, mild in 37.0%, and moderate in 2.5%; no patients had severe PVL. Conclusions One-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE neo2 valve. Graphic Abstract

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