Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis: FinnValve Registry

Aortic Valve Stenosis Clinical Trial

— FinnValve  

Official title:

Nationwide Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis: FinnValve Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03385915
• Other study ID #: T309/2017
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: March 9, 2020

Study information

• Verified date: March 2020
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The FinnValve investigators planned a nationwide registry to investigate the early and late outcome of transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement (SAVR) in patients with aortic valve stenosis performed from 2008 to 2017 at five Finnish University Hospitals. Data will be collected in a dedicated electronic case report form.

Description:

Rationale of the study Uncertainty regarding the potential benefits of transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement (SAVR) in patients with aortic valve stenosis (AS) requires well-designed studies with long-term data on the outcome of these patients. A Finnish nationwide registry would allow complementing of the knowledge gained from randomized trials by providing data on the outcome of a more inclusive patient population, within a Health Care System that reflects the actual clinical practice in Scandinavia. In fact, the internal validity attained in randomized trials is often achieved at the expense of uncertainty about generalizability, especially since the populations enrolled in such studies may differ in significant ways from those seen in practice.

The choice among different surgical aortic valve prostheses is based on solid data with 20-year follow-up, which have shown significant risk of structural valve deterioration of bioprosthesis on the second decade after implantation. However, much less is known about the structural durability of TAVI prostheses beyond 3 years of follow-up. This nationwide registry would provide data on the durability of surgical bioprostheses as well as second and third generation TAVI prostheses at 7 years . Continuous follow-up of these patients will allow monitoring of the durability of these prostheses on the long run.

Furthermore, the introduction of TAVI prompted a rapid development of minimally invasive surgical techniques and rapid deployment surgical bioprostheses in order to reduce the risk of early adverse events after SAVR. However, it is unclear whether these advances have a real clinical benefit on the early and late outcome of patients undergoing SAVR.

Patients and Methods

Patients operated on for AS at each Finnish University Hospitals from January 2008 to September 2017 will included in to this registry. The following inclusion and exclusion criteria will be considered:

Inclusion criteria:

• Patients aged >18 years

• Primary aortic valve procedure with a bioprosthesis for AS with or without associated regurgitation.

• TAVI and SAVR with or without associated coronary revascularization

• TAVI and SAVR for AS after any prior major cardiac surgery with exception of any maze procedure and/or closure of the left atrial appendage.

Exclusion criteria:

• Patients who underwent any prior SAVR or TAVI

• Patients undergoing concomitant procedures on the mitral valve, tricuspid valve or the ascending aorta.

• Patients operated on for aortic valve endocarditis

• Patients operated for isolated aortic valve regurgitation.

Definition criteria for baseline and operative variables as well as early and late outcomes will be according to the Valve Academic Research Consortium (VARC) 2 guidelines (Kappetein et al. Eur J Cardiothorac Surg 2012;42:S45-60). Prosthetic valve structural deterioration and failure will be reported according to the last specific guidelines on this topic (Capodanno et al. Eur J Cardiothorac Surg. 2017;52:408-417). However, because of the lack of complete echocardiographic follow-up in these patients, valve structural valve deterioration will be classified only according to the definition criteria of severe hemodynamic structural valve deterioration of these guidelines.

The late events of interest are all-cause mortality, stroke, myocardial infarction, myocardial revascularization, structural deterioration, non-structural valve dysfunction, repeated procedures on the aortic valve and implantation of permanent pace-maker. Data on these late events will be collected at each participating center. These will be further checked and implemented for patients residing outside the catchment areas by interrogation of the Finnish National Health Institute for Health and Welfare database as well as Statistics Finland database.

Planned studies

The following is a tentatile of study projects which will be accomplished from the FinnValve registry:

1. Late outcome of TAVI versus SAVR in intermediate risk patients

2. Late outcome of TAVI versus SAVR in low risk patients

3. Late outcome of TAVI and SAVR in high risk patients

4. Futility of TAVI (3-month analysis)

5. Mini- versus full-sternotomy SAVR

6. Perceval sutureless bioprosthesis: 5-year outcome

7. Late outcome of sutureless versus conventional stented bioprosthesis in isolated SAVR

8. Late outcome of sutureless SAVR versus transfemoral TAVI in low- and intermediate risk patients

9. Early and late outcome of TAVI versus SAVR in patients with recent acute heart failure

10. Early and late outcome of TAVI versus SAVR in bicuspid AS

11. Early and late outcome of TAVI versus SAVR in obese patients (BMI >29) at low- and intermediate risk

12. Early and late outcome of isolated TAVI versus TAVI plus percutaneous coronary intervention (PCI) in patients with coronary artery disease

13. Early and late outcome of TAVI plus PCI versus SAVR plus coornary artery bypass grafting (CABG)

14. Prognostic impact of Syntax score on the early and late outcome after TAVI

15. Early and late outcome of TAVI vs. SAVR in patients with prior CABG

16. Early and late outcome of second versus third generation TAVI prostheses

17. Early and late outcome of transfemoral versus transaortic TAVI

18. Early and late outcome of trans-subclavian artery versus trans-aortic TAVI

19. Early and late outcome of sutureless versus conventional stented bioprosthesis in SAVR plus CABG

20. Early and late outcome of Trifecta versus Perimount bioprosthesis in isolated SAVR

21. Thromboembolic events after TAVI and SAVR

22. Early and late outcome of TAVI in nonagenarians

23. Prognostic impact of permanent pace-maker implantation on the early and late outcome after TAVI and SAVR

24. Prognostic impact of mild paravalvular leakage on the late outcome after SAVR

25. Impact of preoperative atrial fibrillation on the late outcome of TAVI

26. Impact of preoperative atrial fibrillation on the late outcome of SAVR

27. Early and late outcome of TAVI vs. SAVR in patients aged 85 years or older

Publications of results and PhD studies

The results of these studies will be published in international, peer-reviewed journals in the fields of cardiology and cardiac surgery. Furthermore, data from this registry will be available for several doctoral study projects. At this stage, a proposal for PhD studies has been submitted by:

1. Marko Virtanen, MD (Tampere University Hospital);

2. Pasi Maaranen, MD (Tampere University Hospital)

3. Maina Jalava, MD (Turku University Hospital);

4. Tuomas Ahvenvaara (Oulu University Hospital);

5. Teemu Laakso (Helsinki University Hospital).

Time schedule of data collection, checking and analysis

• December 2017: start of data collection

• End of April 2018: deadline for data collection

• End of May 2018: data checking

• June 2018-December 2019: analyses and writing of the planned studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6463
• Est. completion date: March 9, 2020
• Est. primary completion date: March 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who underwent transcatheter (TAVI) or surgical aortic valve replacement (SAVR) for severe aortic valve stenosis

• Patients aged >18 years

• Primary aortic valve procedure with a bioprosthesis for AS with or without associated regurgitation.

• TAVI and SAVR with or without associated coronary revascularization

• TAVI and SAVR for AS after any prior major cardiac surgery with exception of any maze procedure and/or closure of the left atrial appendage.

Exclusion Criteria:

• Patients who underwent any prior SAVR or TAVI

• Patients undergoing concomitant procedures on the mitral valve, tricuspid valve or the ascending aorta.

• Patients operated on for aortic valve endocarditis

• Patients operated for isolated aortic valve regurgitation.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Procedure:
• Aortic valve replacement
Transcatheter or surgical aortic valve replacement for severe aortic valve stenosis

Locations

Country	Name	City	State
Finland	Heart Center, Turku University Hospital	Turku

Sponsors (5)

Lead Sponsor	Collaborator
Turku University Hospital	Helsinki University Central Hospital, Kuopio University Hospital, Oulu University Hospital, Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	All-cause death	From the index procedure till the end of the follow-up period (December 2017)
Secondary	Atrial fibrillation	Any episode of atrial fibrillation	During the index hospital stay, an average of 7 days
Secondary	Permanent pace-maker implantation	Permanent pace-maker implantation	From the index procedure till the end of the follow-up period (December 2017)
Secondary	Stroke	Stroke	From the index procedure till the end of the follow-up period (December 2017)
Secondary	Infection	Deep sternal wound infection/mediastinitis, vascular access site infection, pneumonia, sepsis	During the index hospital stay, an average of 7 days
Secondary	Acute kidney injury	Postoperative acute kidney injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria	During the index hospital stay, an average of 7 days
Secondary	Bleeding	Minor, major, life-threatening or disabling bleeding according to the VARC 2 definition criteria	During the index hospital stay, an average of 7 days
Secondary	Reoperation for bleeding	Reoperation for bleeding	During the index hospital stay, an average of 7 days
Secondary	Postoperative intra-aortic balloon pump	Postoperative use of intra-aortic balloon pump	During the index hospital stay, an average of 7 days
Secondary	Venoarterial extracorporeal oxygenation	Postoperative use of venoarterial extracorporeal oxygenation	During the index hospital stay, an average of 7 days
Secondary	Intensive care unit stay	Length of stay in the intensive care unit	During the index hospital stay, an average of 7 days
Secondary	Structural valve deterioration	Mean transprosthetic gradient =40 mmHg; Mean transprosthetic gradient =20 mmHg change from baseline; Severe intraprosthetic regurgitation, new or worsening (>2+/4+) from baseline	From the index procedure till the end of the follow-up period (December 2017)
Secondary	Prosthesis thrombosis	Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment	From the index procedure till the end of the follow-up period (December 2017)
Secondary	Prosthesis endocarditis	Prosthesis endocarditis requiring medical or surgical treatment	From the index procedure till the end of the follow-up period (December 2017)
Secondary	Repeat procedure	Repeat procedure on the aortic valve	From the index procedure till the end of the follow-up period (December 2017)
Secondary	Myocardial infarction	Myocardial infarction occurring after discharge after the index procedure	From discharge after the index procedure till the end of the follow-up period (December 2017)
Secondary	Coronary revascularization	Coronary revascularization after discharge after the index procedure	From the index procedure till the end of the follow-up period (December 2017)
Secondary	Paravalvular regurgitation	Paravalvular regurgitation immediately after the index procedure	During the index hospital stay, an average of 7 days
Secondary	TAVI/SAVR prosthesis migration	TAVI/SAVR prosthesis migration	During the index hospital stay, an average of 7 days
Secondary	Annulus rupture	Rupture of the aortic annulus	During the index hospital stay, an average of 7 days
Secondary	Coronary artery ostium occlusion	Coronary artery ostium occlusion during the index procedure	During the index hospital stay, an average of 7 days
Secondary	Ventricular septal perforation	Ventricular septal perforation during the index procedure	During the index hospital stay, an average of 7 days
Secondary	Mitral valve apparatus damage or dysfunction	Mitral valve apparatus damage or dysfunction during the index procedure	During the index hospital stay, an average of 7 days
Secondary	Tamponade	Pericardial tamponade during or immediately after the index procedure	During the index hospital stay, an average of 7 days
Secondary	Vascular injury	Vascular injury during the index procedure	During the index hospital stay, an average of 7 days
Secondary	Injury of the left ventricle wall	Injury of the left ventricle wall during the index procedure	During the index hospital stay, an average of 7 days
Secondary	Need of emergency cardiac surgery	Need of emergency cardiac surgery	During the index hospital stay, an average of 7 days