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