Transcatheter aortic valve implantation (TAVI) in patients at intermediate surgical risk
Abraha I, Chiarolla E, Corio M, Gillespie F, Migliore A, Cerbo M, Lauvrak V, Fagerlund BC, Harboe I, Stoinska-Schneider A, Wild C
Record ID 32018000336
Authors' objectives: Percutaneous aortic valve replacement (also transcatheter aortic valve implantation/ TAVI) means the insertion of a bioprosthesis into the aortic valve using a catheter. In contrast to the conventional method of open heart surgery, surgical aortic valve replacement (SAVR), TAVI is minimally invasive and can be performed with light sedation and without the use of a heart-lung machine. Since the introduction of TAVI in 2007 for patients with a high risk of surgery, the intervention has become increasingly common. The EUnetHTA report with a German-language summary analyses the results of 2 RCTs on patients with moderate surgical risk.
Authors' results and conclusions: Based on the available evidence from two RCTs, it can be summarised that the efficacy of TAVI in patients with severe aortic valve stenosis and moderate surgical risk is unlikely to be inferior to surgical aortic valve replacement (SAVR) in terms of 30-day all-cause mortality and cardiac mortality. In addition, TAVI might reduce the length of hospital stay compared to SAVR. However, significant uncertainties remain as to whether TAVI or SAVR is the better method to improve symptoms. The qualitatively moderate evidence suggests that TAVI is likely to reduce atrial fibrillation and increase the risk of paravalvular regurgitation compared to SAVR. However, significant uncertainties remain with respect to the evidence of stroke, acute renal failure/injury, newly implanted permanent pacemaker, major vascular complications, aortic valve reintervention, and bleeding. Conclusion: There are many uncertainties regarding the available evidence on medium-term outcomes of TAVI in patients with severe aortic stenosis, despite a moderate surgical risk.
Authors' methods: Systematic literature search in several databases, assessment of the risk of bias (RoB) with the Cochrane RoB tool, assessment of the quality of evidence with the GRADE method (Grading of Recommendations, Assessment, Development and Evaluation).
Project Status: Completed
URL for project: https://aihta.at/page/transkatheter-aortenklappenimplantation-tavi-bei-patientinnen-mit-mittlerem-operationsrisiko/de
Year Published: 2019
URL for published report: http://eprints.aihta.at/1188/1/HTA-Projektbericht_Nr.115.pdf
URL for additional information: http://eprints.aihta.at/1188/
English language abstract: An English language summary is available
Publication Type: Full HTA
- Transcatheter Aortic Valve Replacement
- Minimally Invasive Surgical Procedures
- Surgical Procedures, Operative
- Cardiovascular Diseases
- Percutaneous aortic valve replacement
- transcatheter aortic valve implantation (TAVI)
- minimal-invasive surgery
- cardiovascular disease
Organisation Name: Ludwig Boltzmann Institute for Health Technology Assessment
Contact Address: Ludwig Boltzmann Institute for fuer Health Technology Assessment (LBI-HTA), Garnisongasse 7/rechte Stiege Mezzanin (Top 20), 1090 Vienna, Austria. Tel: +43 1 236 8119 - 0 Fax: +43 1 236 8119 - 99
Contact Name: firstname.lastname@example.org
Contact Email: email@example.com
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.