Size Up Bicuspid With the LIra MEthod: the SUBLIME Study

Bicuspid aortic valve (BAV) still represents a challenge for percutaneous treatment due to the peculiar anatomy.

BAV patients have been historically excluded from major randomized controlled trials.

Observational data have showed a high rate of paravalvular leak (PVL) with the use of self-expanding prostheses and a non-negligible rate of annular rupture with the use of balloon expandable valves.

More recent data have shown better outcomes with current generation prostheses although the rate of stroke and permanent pacemaker implantation remains high.

These suboptimal results, possibly related to BAV different anatomy, have advocated the use of different sizing method for prosthesis selection in this setting.

Recent evidence has shown that transcatheter heart valve (THV) anchoring in BAV patients might occur at the raphe-level, defined as the LIRA (Level of Implantation at the RAphe) plane. Thus, a novel supra-annular sizing method based on the measurement of the perimeter at the raphe-level, the LIRA-method, has been developed in our center and validated in small cohorts of patients.

The aim of our study is to evaluate the efficacy and safety of the LIRA method in raphe-type bicuspid patients undergoing TAVR.

Primary outcomes

• Device success [Up to 30 days after TAVI procedure]: Device success as defined by VARC 3 criteria : presence of technical success, freedom from mortality, freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complications, intended performance of the valve (less than moderate aortic regurgitation, mean gradient < 20 mmHg, peak velocity <3 m/s, doppler velocity index >0.25).

Secondary outcomes

• Number of partecipants with TAVI-related Adverse Events as assessed by VARC 3 criteria. [Up to 30 days after TAVI procedure]: * All-cause mortality * All stroke * VARC type 2-4 bleeding * Major vascular, access-related, or cardiac structural complication * Acute kidney injury stage 3 or 4 * New permanent pacemaker due to procedure- related conduction abnormalities * Surgery or intervention related to the device
• Clinical efficacy [Up to 1 year after TAVI procedure]: Freedom from all-cause mortality, freedom from all stroke, freedom from hospitalization for procedure -or-valve-related causes, freedom from KCCQ Overall Summary score <45 or decline from baseline >10 point
• Technical success [At exit from procedure room]: Freedom from mortality; successful access, delivery and retrieval of the delivery system; correct positioning of a single prosthetic heart valve into the proper anatomical location; freedom from surgey or intervention related to the device or to a major vascular or access-related, or cardiac structural.
• Intended performance of the valve [Up to 30 days after TAVI procedure]: Less than moderate aortic regurgitation, mean gradient < 20 mmHg, peak velocity <3 m/s, doppler velocity index >0.25

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* All patients over 18 years old with severe aortic stenosis and type 1 or 2 BAV according to Sievers classification) undergone TAVR with self-expanding supra-annular prostheses sized according to the LIRA method between September 2018 and June 2024

Exclusion Criteria:

* Redo-TAVR
* TAVR performed in emergency setting
* TAVR performed for severe aortic regurgitation

• Results publication: Hayashida K, Bouvier E, Lefevre T, Chevalier B, Hovasse T, Romano M, Garot P, Watanabe Y, Farge A, Donzeau-Gouge P, Cormier B, Morice MC. Transcatheter aortic valve implantation for patients with severe bicuspid aortic valve stenosis. Circ Cardiovasc Interv. 2013 Jun;6(3):284-91. doi: 10.1161/CIRCINTERVENTIONS.112.000084. Epub 2013 Jun 11. PMID 23756698
• Results publication: Bauer T, Linke A, Sievert H, Kahlert P, Hambrecht R, Nickenig G, Hauptmann KE, Sack S, Gerckens U, Schneider S, Zeymer U, Zahn R. Comparison of the effectiveness of transcatheter aortic valve implantation in patients with stenotic bicuspid versus tricuspid aortic valves (from the German TAVI Registry). Am J Cardiol. 2014 Feb 1;113(3):518-21. doi: 10.1016/j.amjcard.2013.10.023. Epub 2013 Nov 9. PMID 24342758
• Results publication: Perlman GY, Blanke P, Dvir D, Pache G, Modine T, Barbanti M, Holy EW, Treede H, Ruile P, Neumann FJ, Gandolfo C, Saia F, Tamburino C, Mak G, Thompson C, Wood D, Leipsic J, Webb JG. Bicuspid Aortic Valve Stenosis: Favorable Early Outcomes With a Next-Generation Transcatheter Heart Valve in a Multicenter Study. JACC Cardiovasc Interv. 2016 Apr 25;9(8):817-824. doi: 10.1016/j.jcin.2016.01.002. PMID 27101906
• Results publication: Yoon SH, Lefevre T, Ahn JM, Perlman GY, Dvir D, Latib A, Barbanti M, Deuschl F, De Backer O, Blanke P, Modine T, Pache G, Neumann FJ, Ruile P, Arai T, Ohno Y, Kaneko H, Tay E, Schofer N, Holy EW, Luk NHV, Yong G, Lu Q, Kong WKF, Hon J, Kao HL, Lee M, Yin WH, Park DW, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Kim HS, Butter C, Khalique OK, Schaefer U, Nietlispach F, Kodali SK, Leon MB, Ye J, Chevalier B, Leipsic J, Delgado V, Bax JJ, Tamburino C, Colombo A, Sondergaard L, Webb JG, Park SJ. Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis. J Am Coll Cardiol. 2016 Sep 13;68(11):1195-1205. doi: 10.1016/j.jacc.2016.06.041. PMID 27609682
• Results publication: Iannopollo G, Romano V, Buzzatti N, De Backer O, Sondergaard L, Merkely B, Prendergast BD, Giannini F, Colombo A, Latib A, Granada JF, Chieffo A, Montorfano M. A novel supra-annular plane to predict TAVI prosthesis anchoring in raphe-type bicuspid aortic valve disease: the LIRA plane. EuroIntervention. 2020 Jun 25;16(3):259-261. doi: 10.4244/EIJ-D-19-00951. No abstract available. PMID 31659989
• Results publication: Iannopollo G, Romano V, Buzzatti N, Ancona M, Ferri L, Russo F, Bellini B, Granada JF, Chieffo A, Montorfano M. Supra-annular sizing of transcatheter aortic valve prostheses in raphe-type bicuspid aortic valve disease: the LIRA method. Int J Cardiol. 2020 Oct 15;317:144-151. doi: 10.1016/j.ijcard.2020.05.076. Epub 2020 May 28. PMID 32473284
• Results publication: Iannopollo G, Romano V, Esposito A, Guazzoni G, Ancona M, Ferri L, Russo F, Bellini B, Buzzatti N, Curio J, Prendergast B, Montorfano M. Update on supra-annular sizing of transcatheter aortic valve prostheses in raphe-type bicuspid aortic valve disease according to the LIRA method. Eur Heart J Suppl. 2022 May 18;24(Suppl C):C233-C242. doi: 10.1093/eurheartj/suac014. eCollection 2022 May. PMID 35602251

• Prof. Matteo Montorfano, MD, Principal investigator, IRCCS San Raffaele Scientific Institute