Multicentre clinical study evaluating a novel resheathable annular functioning self-expanding transcatheter aortic valve system: Safety and performance results at 30 days with the Portico system

EuroIntervention

Volumn 12, Issue 6, 2016, Pages 768-774

  Manoharan, Ganesh ^a   Linke, Axel ^b   Moellmann, Helge ^c   Redwood, Simon ^d   Frerker, Christian ^e   Kovac, Jan ^f   Walther, Thomas ^c  

^a ROYAL VICTORIA HOSPITAL   (United Kingdom)

^b UNIVERSITY OF LEIPZIG   (Germany)

^c KERCKHOFF HEART CENTER   (Germany)

^d ST THOMAS HOSPITAL   (United Kingdom)

^e DEPARTMENT OF CARDIOLOGY   (Germany)

^f GLENFIELD HOSPITAL   (United Kingdom)

Author keywords

Aortic stenosis; Elderly; Femoral; Heart failure; Transcatheter aortic valve implantation

Indexed keywords

ACUTE KIDNEY FAILURE; AGED; AORTA STENOSIS; AORTA VALVE REPLACEMENT; ARTICLE; CARDIOVASCULAR DISEASE; CAUSE OF DEATH; CEREBROVASCULAR ACCIDENT; DEVICE SAFETY; ECHOCARDIOGRAPHY; FEMALE; FOLLOW UP; HEART INFARCTION; HIGH RISK PATIENT; HUMAN; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; PARAVALVULAR LEAK; PERCUTANEOUS AORTIC VALVE; POSTOPERATIVE HEMORRHAGE; PROSPECTIVE STUDY; SELF EXPANDING STENT; SINGLE BLIND PROCEDURE; TRANSCATHETER AORTIC VALVE IMPLANTATION; TRANSIENT ISCHEMIC ATTACK; AORTIC VALVE; AORTIC VALVE STENOSIS; CLINICAL TRIAL; DEVICES; HEART VALVE PROSTHESIS; STATISTICS AND NUMERICAL DATA; TREATMENT OUTCOME; VERY ELDERLY;

AGED; AGED, 80 AND OVER; AORTIC VALVE; AORTIC VALVE STENOSIS; ECHOCARDIOGRAPHY; FEMALE; HEART VALVE PROSTHESIS; HUMANS; MALE; PROSPECTIVE STUDIES; TRANSCATHETER AORTIC VALVE REPLACEMENT; TREATMENT OUTCOME;

EID: 84983028186     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJV12I6A125     Document Type: Article

References (25)

1. Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63:e57-185.
2. Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS), Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Barón-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schäfers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J. 2012;33:2451-96.
3. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic valve replacement in highrisk patients. N Engl J Med. 2011;364:2187-98.
4. Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U. S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a selfexpanding prosthesis. N Engl J Med. 2014;370:1790-8.
5. Généreux P, Head SJ, Hahn R, Daneault B, Kodali S, Williams MR, van Mieghem NM, Alu MC, Serruys PW, Kappetein AP, Leon MB. Paravalvular leak after transcatheter aortic valve replacement: the new Achilles' heel? A comprehensive review of the literature. J Am Coll Cardiol. 2013;61:1125-36.
6. Siontis GC, Jüni P, Pilgrim T, Stortecky S, Büllesfeld L, Meier B, Wenaweser P, Windecker S. Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR: a meta-analysis. J Am Coll Cardiol. 2014;64: 129-40.
7. Manoharan G, Spence MS, Rodés-Cabau J, Webb JG. St Jude Medical Portico valve. EuroIntervention. 2012;8:Q97-101.
8. Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein AP, Krucoff MW, Mack M, Mehran R, Miller C, Morel MA, Petersen J, Popma JJ, Takkenberg JJ, Vahanian A, van Es GA, Vranckx P, Webb JG, Windecker S, Serruys PW. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol. 2011;57: 253-69.
9. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597-607.
10. Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Coselli J, Diez J, Kafi A, Schreiber T, Gleason TG, Conte J, Buchbinder M, Deeb GM, Carabello B, Serruys PW, Chenoweth S, Oh JK. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014;63:1972-81.
11. Meredith Am IT, Walters DL, Dumonteil N, Worthley SG, Tchétché D, Manoharan G, Blackman DJ, Rioufol G, Hildick-Smith D, Whitbourn RJ, Lefèvre T, Lange R, Müller R, Redwood S, Allocco DJ, Dawkins KD. Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study. J Am Coll Cardiol. 2014;64:1339-48.
12. Schofer J, Colombo A, Klugmann S, Fajadet J, DeMarco F, Tchétché D, Maisano F, Bruschi G, Latib A, Bijuklic K, Weissman N, Low R, Thomas M, Young C, Redwood S, Mullen M, Yap J, Grube E, Nickenig G, Sinning JM, Hauptmann KE, Friedrich I, Lauterbach M, Schmoeckel M, Davidson C, Lefevre T. Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve. J Am Coll Cardiol. 2014;63:763-8.
13. Webb J, Gerosa G, Lefèvre T, Leipsic J, Spence M, Thomas M, Thielmann M, Treede H, Wendler O, Walther T. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014;64:2235-43.
14. Tamburino C, Capodanno D, Ramondo A, Petronio AS, Ettori F, Santoro G, Klugmann S, Bedogni F, Maisano F, Marzocchi A, Poli A, Antoniucci D, Napodano M, De Carlo M, Fiorina C, Ussia GP. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation. 2011;123:299-308.
15. Nombela-Franco L, Rodés-Cabau J, DeLarochellière R, Larose E, Doyle D, Villeneuve J, Bergeron S, Bernier M, Amat-Santos IJ, Mok M, Urena M, Rheault M, Dumesnil J, Côté M, Pibarot P, Dumont E. Predictive factors, efficacy, and safety of balloon post-dilation after transcatheter aortic valve implantation with a balloon-expandable valve. JACC Cardiovasc Interv. 2012;5:499-512.
16. Daneault B, Koss E, Hahn RT, Kodali S, Williams MR, Généreux P, Paradis JM, George I, Reiss GR, Moses JW, Smith CR, Leon MB. Efficacy and safety of postdilatation to reduce paravalvular regurgitation during balloon-expandable transcatheter aortic valve replacement. Circ Cardiovasc Interv. 2013;6:85-91.
17. Hahn RT, Pibarot P, Webb J, Rodes-Cabau J, Herrmann HC, Williams M, Makkar R, Szeto WY, Main ML, Thourani VH, Tuzcu EM, Kapadia S, Akin J, McAndrew T, Xu K, Leon MB, Kodali SK. Outcomes with post-dilation following transcatheter aortic valve replacement: the PARTNER I trial (placement of aortic transcatheter valve). JACC Cardiovasc Interv. 2014;7:781-9.
18. Ribeiro HB, Webb JG, Makkar RR, Cohen MG, Kapadia SR, Kodali S, Tamburino C, Barbanti M, Chakravarty T, Jilaihawi H, Paradis JM, de Brito FS Jr, Cánovas SJ, Cheema AN, de Jaegere PP, del Valle R, Chiam PT, Moreno R, Pradas G, Ruel M, Salgado-Fernández J, Sarmento-Leite R, Toeg HD, Velianou JL, Zajarias A, Babaliaros V, Cura F, Dager AE, Manoharan G, Lerakis S, Pichard AD, Radhakrishnan S, Perin MA, Dumont E, Larose E, Pasian SG, Nombela-Franco L, Urena M, Tuzcu EM, Leon MB, Amat-Santos IJ, Leipsic J, Rodés-Cabau J. Predictive factors, management, and clinical outcomes of coronary obstruction following transcatheter aortic valve implantation: insights from a large multicenter registry. J Am Coll Cardiol. 2013;62:1552-62.
19. Pasic M, Unbehaun A, Dreysse S, Buz S, Drews T, Kukucka M, D'Ancona G, Seifert B, Hetzer R. Rupture of the device landing zone during transcatheter aortic valve implantation: a life-threatening but treatable complication. Circ Cardiovasc Interv. 2012;5:424-32.
20. Holmes DR Jr, Mack MJ, Kaul S, Agnihotri A, Alexander KP, Bailey SR, Calhoon JH, Carabello BA, Desai MY, Edwards FH, Francis GS, Gardner TJ, Kappetein AP, Linderbaum JA, Mukherjee C, Mukherjee D, Otto CM, Ruiz CE, Sacco RL, Smith D, Thomas JD. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol. 2012;59:1200-54.
21. Tzikas A, van Dalen BM, Van Mieghem NM, Gutierrez-Chico JL, Nuis RJ, Kauer F, Schultz C, Serruys PW, de Jaegere PP, Geleijnse ML. Frequency of conduction abnormalities after transcatheter aortic valve implantation with the Medtronic-CoreValve and the effect on left ventricular ejection fraction. Am J Cardiol. 2011;107:285-9.
22. Tchetche D, Modine T, Farah B, Vahdat O, Sudre A, Koussa M, Lereun C, Nejjari M, Choby M, Rosencher J, Sorbets E, Fajadet J. Update on the need for a permanent pacemaker after transcatheter aortic valve implantation using the CoreValve Accutrak system. EuroIntervention. 2012;8:556-62.
23. Webb JG, Wood DA. Current status of transcatheter aortic valve replacement. J Am Coll Cardiol. 2012;60:483-92.
24. Petronio AS, Sinning JM, Van Mieghem N, Zucchelli G, Nickenig G, Bekeredjian R, Bosmans J, Bedogni F, Branny M, Stangl K, Kovac J, Schiltgen M, Kraus S, de Jaegere P. Optimal Implantation Depth and Adherence to Guidelines on Permanent Pacing to Improve the Results of Transcatheter Aortic Valve Replacement With the Medtronic CoreValve System: The CoreValve Prospective, International, Post-Market ADVANCE-II Study. JACC Cardiovasc Interv. 2015;8:837-46.
25. Manoharan G, Walton AS, Brecker SJ, Pasupati S, Blackman DJ, Qiao H, Meredith IT. Treatment of Symptomatic Severe Aortic Stenosis with a Novel Resheathable Supra-Annular Self-Expanding Transcatheter Aortic Valve System. JACC Cardiovasc Interv. 2015;8:1359-67.