SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI

Conditions

Aortic Stenosis

Brief summary

Aim of the study is to demonstrate equivalence of second-generation self-expandable valves (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards Sapien 3) and of local anesthesia with conscious sedation in comparison to general anesthesia with respect to safety and efficacy in high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.

Serdar Farhan, Georg Stachel, Steffen Desch, Thomas Kurz, Hans‐Josef Feistritzer et al. (22 authors)

EuroIntervention2022-10-0110 citations

10.4244/eij-d-22-00156

Fractal dimension of the aortic annulus: a novel predictor of paravalvular leak after transcatheter aortic valve implantation

Georg Stachel, Mohamed Abdel‐Wahab, Suzanne de Waha‐Thiele, Steffen Desch, Hans‐Josef Feistritzer et al. (10 authors)

The International Journal of Cardiovascular Imaging2022-06-242 citations

10.1007/s10554-022-02657-1

Impact of Anesthesia Strategy and Valve Type on Clinical Outcomes After Transcatheter Aortic Valve Replacement.

Feistritzer HJ, Kurz T, Stachel G, Hartung P, Lurz P, Eitel I, Marquetand C, Nef H, Doerr O, Vigelius-Rauch U, Lauten A, Landmesser U, Treskatsch S, Abdel-Wahab M, Sandri M, Holzhey D, Borger M, Ender J, Ince H, Öner A, Meyer-Saraei R, Hambrecht R, Wienbergen H, Fach A, Augenstein T, Frey N, König IR, Vonthein R, Funkat AK, Berggreen AE, Heringlake M, Desch S, de Waha-Thiele S, Thiele H, SOLVE-TAVI Investigators.

2021-05-0145 citations

10.1016/j.jacc.2021.03.007

General Versus Local Anesthesia With Conscious Sedation in Transcatheter Aortic Valve Implantation

Hölger Thiele, Thomas Kurz, Hans‐Josef Feistritzer, Georg Stachel, Philipp Hartung et al. (35 authors)

Circulation2020-08-21149 citations

10.1161/circulationaha.120.046451

Interventions

DEVICECoreValve Evolut R

DEVICEEdwards Sapien 3

PROCEDURELocal anesthesia with conscious sedation

PROCEDUREGeneral anesthesia

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

* Severe symptomatic aortic valve stenosis defined as aortic valve area (AVA) ≤ 1cm2 or 0.6 cm²/m² * Age ≥75 years and/or logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥20% and/or Society of Thoracic Surgeons (STS) risk score ≥10% and/or high risk/contraindication to conventional surgical aortic valve replacement * Native aortic valve annulus measuring 18-29 mm * Suitability for transfemoral vascular access * Written informed consent

Exclusion criteria

* Life expectancy \<12 months due to comorbidities * Cardiogenic shock or hemodynamic instability * History of or active endocarditis * Contraindications for transfemoral access * Active peptic ulcer or upper gastro-intestinal bleeding \<3 months * Hypersensitivity or contraindication to aspirin, heparin or clopidogrel * Contraindication for a specific mode of anesthesia as judged by the cardiac anesthesia representative of the Heart Team * Active infection requiring antibiotic treatment * Participation in another trial

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Treatment-Emergent Adverse Events (Device)	30 day follow-up	Number of participants with adverse events related to the treatment at 30-day follow-up consisting of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation
Incidence of Treatment-Emergent Adverse Events (Anesthesia)	30 day follow-up	Number of participants with adverse events related to the treatment at 30-day follow-up consisting of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury

Countries

Germany

Outcome results

None listed