Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial

Florence Leclercq, Pierre Robert, Jessica Labour, Benoit Lattuca, Mariama Akodad, Jean-Christophe Macia, Richard Gervasoni, Francois Roubille, Thomas Gandet, Laurent Schmutz, Erika Nogue, Nicolas Nagot, Bernard Albat, Guillaume Cayla, Florence Leclercq, Pierre Robert, Jessica Labour, Benoit Lattuca, Mariama Akodad, Jean-Christophe Macia, Richard Gervasoni, Francois Roubille, Thomas Gandet, Laurent Schmutz, Erika Nogue, Nicolas Nagot, Bernard Albat, Guillaume Cayla

Abstract

Background: Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence has suggested that aortic valvuloplasty may cause complications and that high success rates may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation of the aortic valve and using new-generation balloon-expandable transcatheter heart valves is associated with a better net clinical benefit than TAVI performed with predilatation.

Methods/design: The transcatheter aortic valve implantation without prior balloon dilatation (DIRECTAVI) trial is a randomized controlled open label trial that includes 240 patients randomized to TAVI performed with prior balloon valvuloplasty (control arm) or direct implantation of the valve (test arm). All patients with an indication for TAVI will be included excepting those requiring transapical access. The trial tests the hypothesis that the strategy of direct implantation of the new-generation balloon-expandable SAPIEN 3 valve is noninferior to current medical practice using predilatation of the valve. The primary endpoint assessing efficacy and safety of the procedure consists of immediate procedural success and secondary endpoints include complications at 30-day follow-up (VARC-2 criteria). A subgroup analysis evaluates neurological ischemic events with cerebral MRI imaging (25 patients in each strategy group) performed before and between 1 and 3 days after the procedure.

Discussion: This prospective randomized study is designed to assess the efficacy and safety of TAVI performed without prior dilatation of the aortic valve using new-generation balloon-expandable transcatheter heart valves. We aim to provide robust evidence of the advantages of this strategy to allow the interventional cardiologist to use it in everyday practice.

Trial registration: ClinicalTrials.gov identifier: NCT02729519 . Registered on 15 July 2016.

Keywords: Balloon aortic valvuloplasty; Procedural success; Randomized clinical trial; Safety; Transcatheter aortic valve implantation (TAVI).

Figures

Fig. 1
Fig. 1
Flow chart of the study. BAV balloon aortic valvuloplasty, MDT multidisciplinary heart team, MACCE major adverse cardiovascular and cerebral events
Fig. 2
Fig. 2
The transcatheter aortic valve implantation without prior balloon dilatation (DIRECTAVI) trial

References

    1. Vahanian A, Alfieri O, Andreotti F, Antunes M, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schafers HS, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppel UO, Windecker S, Zamorano JL, Zembala M. Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the management of valvular heart disease of the European Society of Cardiology (ESC) and the Association for Cardio-Thoracic Surgery (EACTS) Eur Heart J. 2012;42:S1–44.
    1. Smith CR, Leon MB, Mack MJ, Miller C, Moses JW, Swensson LG, Tuzcu EM, Webb JG, Fontanna GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babalarios V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ, for the PARTNER trial investigators Transcatheter versus surgical aortic valve replacement in high-risk patients. N Engl J Med. 2011;364:2187–98. doi: 10.1056/NEJMoa1103510.
    1. Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Lefevre T, Himbert D, Tchetche D, Carrié D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S, Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M. Registry of transcatheter aortic valve implantation in high-risk patients. N Engl J Med. 2012;366:1705–15. doi: 10.1056/NEJMoa1114705.
    1. Eltchaninoff H, Prat A, Gilard M, Leguerrier A, Blanchard D, Fournial G, Iung B, Donzeau-Gouge P, Tribouilloy C, Debrux JL, Pavie A, Gueret P. Transcatheter aortic valve implantation: early results of the FRANCE (FRenchAortic National CoreValve and Edwards) Registry. Eur Heart J. 2011;32:191–7. doi: 10.1093/eurheartj/ehq261.
    1. Rodés-Cabau J, Webb JG, Cheung A, Ye J, Dumont E, Feindel CM, Osten M, Natarajan MK, Velianou JL, Martucci G, DeVarennes B, Chisholm R, Peterson MD, Lichtenstein SV, Nietlispach F, Doyle D, DeLarochellière R, Teoh K, Chu V, Dancea A, Lachapelle K, Cheema A, Latter D, Horlick E. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol. 2010;55:1080–90. doi: 10.1016/j.jacc.2009.12.014.
    1. Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H, Eggebrecht H, Rubino P, Michev I, Lange R, Anderson WN, Wendler O. Thirty-day results of the SAPIEN aortic bioprosthesis European Outcome (SOURCE) Registry: a European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2010;122:62–9. doi: 10.1161/CIRCULATIONAHA.109.907402.
    1. Eltchaninoff H, Cribier A, Tron C, Anselme F, Koning R, Soyer R, Letac B. Balloon aortic valvuloplasty in elderly patients at high risk for surgery, or inoperable: immediate and mid-term results. Eur Heart J. 1995;16:1079–84. doi: 10.1093/oxfordjournals.eurheartj.a061050.
    1. Sack S, Kahlert P, Khandanpour S, Naber C, Philipp S, Möhlenkamp S, Sievers B, Kälsch H, Erbel R. Revival of an old method with new techniques: balloon aortic valvuloplasty of the calcified aortic stenosis in the elderly. Clin Res Cardiol. 2008;97:288–97. doi: 10.1007/s00392-008-0650-0.
    1. Kahlert P, Al-Rashid F, Döttger P, Mori C, Plicht B, Wendt D, Bergmann L, Kottenberg E, Schlamann M, Mummel P, Holle D, Thielmann M, Jakob HG, Konorza T, Heusch G, Erbel R, Eggebrecht H. Cerebral embolization during transcatheter aortic valve implantation: a transcranial Doppler study. Circulation. 2012;126:1245–55. doi: 10.1161/CIRCULATIONAHA.112.092544.
    1. Grube E, Naber C, Abizaid A, Sousa E, Mendiz O, Lemos P, Kalil Filho R, Mangione J, Buellesfeld L. Feasibility of transcatheter aortic valve implantation without balloon pre-dilation. A pilot study. J Am Coll Cardiol Intv. 2011;4:751–7. doi: 10.1016/j.jcin.2011.03.015.
    1. Nombela-Franco L, Webb J, de Jaegere PP, Toggweiler S, Nuis RJ, Dager AE, Amat-Santos IJ, Cheung A, Ye J, Binder RK, Van der Boon RM, Van Mieghem N, Benitez LM, Perez S, Lopez J, San Roman JA, Doyle D, DeLarochellière R, Urena M, Leipsic J, Dumont E, Rodes-Cabau J. Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation. Circulation. 2012;126:3041–53. doi: 10.1161/CIRCULATIONAHA.112.110981.
    1. Kahlert P, Knipp SC, Schlamann M, Thielmann M, Al-Rashid F, Weber M, Johansson U, Wendt D, Jakob HG, Forsting M, Sack S, Erbel R, Eggebrecht H. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study. Circulation. 2010;121:870–8. doi: 10.1161/CIRCULATIONAHA.109.855866.
    1. Fiorina C, Maffeo D, Curello S, Lipartiti F, D’Aloia GCA, Adamo M, Mastropierro R, Gavazzi E, Chiari CCE, Ettori F. Direct transcatheter aortic valve implantation with self-expandable bioprosthesis: feasibility and safety. Cardiovasc Revasc Med. 2014;15:200–3. doi: 10.1016/j.carrev.2014.03.005.
    1. Möllmann H, Kim WK, Kempfert J, Blumenstein J, Liebetrau C, Nef H, Van Linden A, Walther T, Hamm C. Transfemoral aortic valve implantation of Edwards SAPIEN XT without predilatation is feasible. Clin Cardiol. 2014;37:667–71. doi: 10.1002/clc.22318.
    1. Binder R, Rodés-Cabau J, Wood DA, Mok M, Leipsic J, De Larochellière R, Toggweiler S, Dumont E, Freeman M, Willson AB, Webb JG. Transcatheter aortic valve replacement with the SAPIEN 3: a new balloon-expandable transcatheter heart valve. J Am Coll Cardiol Intv. 2013;6:293–300. doi: 10.1016/j.jcin.2012.09.019.
    1. Leclercq F, Akodad M, Macia JC, Gandet T, Lattuca B, Schmutz L, Gervasoni R, Nogues E, Nagot N, Levy G, Maupas E, Robert G, Targoz F, Vernhet H, Cayla G, Albat B. Vascular complications and bleeding after transfemoral transcatheter aortic valve implantation performed through open surgical access. Am J Cardiol. 2015;116:1399–404. doi: 10.1016/j.amjcard.2015.08.003.
    1. Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: The Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013;145:6–23. doi: 10.1016/j.jtcvs.2012.09.002.
    1. Bijuklic K, Haselbach T, Witt J, Krause K, Hansen L, Gehrckens R, Rieß FC, Schofer J. Increased risk of cerebral embolization after implantation of a balloon-expandable aortic valve without prior balloon valvuloplasty. J Am Coll Cardiol Intv. 2015;8:1608–13. doi: 10.1016/j.jcin.2015.07.013.
    1. Little RJ, D’Agostino R, Cohen ML, Dickersin K, Emerson SS, Farrar JT, Frangakis C, Hogan JW, Molenberghs G, Murphy SA, Neaton JD, Rotnitzky A, Scharfstein D, Shih WJ, Siegel JP, Stern H. The prevention and treatment of missing data in clinical trials. N Engl J Med. 2012;367:1355–60. doi: 10.1056/NEJMsr1203730.
    1. Bashore T, Berman AD, Davidson CJ, Mickel MC, Kennedy JW, Davis K. The NHLBI balloon valvuloplasty registry participants. Percutaneous balloon aortic valvuloplasty. Acute and 30-day follow-up results in 674 patients from the NHLBI Balloon Valvuloplasty Registry. Circulation. 1991;84:2383–9. doi: 10.1161/01.CIR.84.6.2383.
    1. Grube E, Buellesfeld L, Mueller R, Sauren B, Zickmann B, Nair D, Beucher H, Felderhoff T, Iversen S, Gerckens U. Progress and current status of percutaneous aortic valve replacement: results of three device generations of the CoreValve Revalving System. Circ Cardiovasc Interv. 2008;1:167–75. doi: 10.1161/CIRCINTERVENTIONS.108.819839.
    1. Chan PH, Mario CD, Moat N. Transcatheter aortic valve implantation without balloon predilatation: not always feasible. Catheter Cardiovasc Interv. 2013;82:328–32. doi: 10.1002/ccd.24381.
    1. Liao YB, Meng Y, Zhao ZG, Zuo ZL, Li YJ, Xiong TY, Cao JY, Xu YN, Feng Y, Chen M. Meta-analysis of the effectiveness and safety of transcatheter aortic valve implantation without balloon predilation. doi:10.1016/j.amjcard.2016.02.036.
    1. Pagnesi M, Jabbour RJ, Latib A, Kawamoto H, Tanaka A, Regazzoli D, Mangieri A, Montalto C, Ancona M, Giannini F, Chieffo A, Montorfano M, Monaco F, Castiglioni A, Alfieri O, Colombo A. Usefulness of predilatation prior to transcatheter aortic valve implantation. doi:10.1016/j.amjcard.2016.04.018.
    1. Leclercq F, Labour J, de Champfleur N, Lattuca B, Gandet T, Macia JC, Agullo A, Schmutz L, Gervasoni R, Vernhet H, Albat B, Cayla G. Periprocedural cerebral ischemic events with TAVI performed without prior balloon dilatation of the aortic valve: a pilot prospective study. Circulation. 2015;132:A 11735.
    1. Transcatheter aortic valve implantation without predilation (SIMPLIFy TAVI): Identifier:NCT01539746.
    1. Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG, for the PARTNER 2 Investigators. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. doi:10.1056/NEJMoa1514616.

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi