Implantation and 30-Day Follow-Up on All 4 Valve Sizes Within the Portico Transcatheter Aortic Bioprosthetic Family

JACC: Cardiovascular Interventions

Volumn 10, Issue 15, 2017, Pages 1538-1547

  Möllmann, Helge ^a   Linke, Axel ^b   Holzhey, David M ^b   Walther, Thomas ^c   Manoharan, Ganesh ^d   Schäfer, Ulrich ^e   Heinz Kuck, Karl ^f   Van Boven, Ad J ^g   Redwood, Simon R ^h   Kovac, Jan ⁱ   Butter, Christian ^j   Søndergaard, Lars ^k   Lauten, Alexander ^l   Schymik, Gerhard ^m   Worthley, Stephen G ⁿ  

^a ST JOHANNES HOSPITAL   (Germany)

^b UNIVERSITY OF LEIPZIG HEART CENTER   (Germany)

^c KERCKHOFF HEART CENTER   (Germany)

^d ROYAL VICTORIA HOSPITAL   (United Kingdom)

^e UNIVERSITY HEART CENTER HAMBURG   (Germany)

^f Asklepios Kliniken Hamburg   (Germany)

^g Centre for Infectious Diseases Friesland Leeuwarden   (Netherlands)

^h ST THOMAS HOSPITAL   (United Kingdom)

ⁱ GLENFIELD HOSPITAL   (United Kingdom)

^j Heart Centre Brandenburg   (Germany)

^k Rigshospitalet   (Denmark)

^l CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^m Municipal Hospital Karlsruhe   (Germany)

ⁿ Genesis Cancer Care   (Australia)

more..

Author keywords

all cause mortality; hemodynamic performance; TAVR; transcatheter aortic valve replacement; transfemoral

Indexed keywords

ACUTE KIDNEY FAILURE; AGED; AORTIC STENOSIS; AORTIC VALVE; ARTICLE; ARTIFICIAL HEART PACEMAKER; BRAIN HEMORRHAGE; CARDIOGENIC SHOCK; CEREBROVASCULAR ACCIDENT; CLINICAL EFFECTIVENESS; CLINICAL EVALUATION; CLINICAL FEATURE; CORONARY ARTERY OBSTRUCTION; DISEASE SEVERITY; FEMALE; FOLLOW UP; FUNCTIONAL STATUS; GASTROINTESTINAL HEMORRHAGE; HEART INFARCTION; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MORTALITY RATE; MULTICENTER STUDY; MULTIPLE ORGAN FAILURE; NEW YORK HEART ASSOCIATION CLASS; OUTCOME ASSESSMENT; PACEMAKER IMPLANTATION; PARAVALVULAR LEAK; PATIENT SAFETY; PERCUTANEOUS AORTIC VALVE; PERICARDIAL EFFUSION; PNEUMONIA; PRIORITY JOURNAL; PROSPECTIVE STUDY; PSEUDOMEMBRANOUS COLITIS; RESPIRATORY FAILURE; RISK ASSESSMENT; RISK FACTOR; SOCIETY OF THORACIC SURGEONS SCORE; SURGICAL MORTALITY; SURGICAL RISK; TRANSCATHETER AORTIC VALVE IMPLANTATION; TRANSIENT ISCHEMIC ATTACK; VASCULAR ACCESS; VASCULAR DISEASE; VERY ELDERLY; AORTIC VALVE STENOSIS; AUSTRALIA; BIOPROSTHESIS; CLINICAL TRIAL; CONVALESCENCE; DEVICES; DIAGNOSTIC IMAGING; EUROPE; HEART VALVE PROSTHESIS; HEMODYNAMICS; MORTALITY; PATHOPHYSIOLOGY; POSTOPERATIVE COMPLICATION; PROSTHESIS DESIGN; SEVERITY OF ILLNESS INDEX; TIME FACTOR; TREATMENT OUTCOME;

AGED; AGED, 80 AND OVER; AORTIC VALVE; AORTIC VALVE STENOSIS; AUSTRALIA; BIOPROSTHESIS; EUROPE; FEMALE; HEART VALVE PROSTHESIS; HEMODYNAMICS; HUMANS; MALE; POSTOPERATIVE COMPLICATIONS; PROSPECTIVE STUDIES; PROSTHESIS DESIGN; RECOVERY OF FUNCTION; RISK FACTORS; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TRANSCATHETER AORTIC VALVE REPLACEMENT; TREATMENT OUTCOME;

EID: 85027563581     PISSN: 19368798     EISSN: 18767605     Source Type: Journal    
DOI: 10.1016/j.jcin.2017.05.021     Document Type: Article

References (29)

1. Nishimura, R., Otto, C., Bonow, R., et al. 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. Circulation 129 (2014), e521–e643.
2. Vahanian, A., Alifieri, O., Andreotti, F., et al. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J 33 (2012), 2451–2496.
3. Leon, M., Smith, C., Mack, M., et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 363 (2010), 1597–1607.
4. Smith, C., Leon, M., Mack, M., et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 364 (2011), 2187–2198.
5. Adams, D., Popma, J., Reardon, M., et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 370 (2014), 1790–1798.
6. Malaisrie, S., McCarthy, P., McGee, E., et al. Contemporary perioperative results of isolated aortic valve replacement for aortic stenosis. Ann Thorac Surg 89 (2010), 751–756.
7. Grube, E., Schuler, G., Buellesfeld, L., et al. Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and third-generation self-expanding corevalve prosthesis. J Am Coll Cardiol 50 (2007), 69–76.
8. Webb, J., Pasupati, S., Humphries, K., et al. Percutaneous transarterial aortic valve replacement in selected high-risk patients with aortic stenosis. Circulation 116 (2007), 755–763.
9. Manoharan, G., Spence, M., Rodes-Cabau, J., Webb, J., St Jude Medical Portico valve. EuroIntervention 8 (2012), Q97–Q101.
10. Chandrasehkar, J., Glover, C., Labinaz, M., Ruel, M., First aortic retrievable transcatheter aortic valve implantation in humans. Can J Cardiol 30 (2014), 1461.e9–1461.e11.
11. Del Trigo, M., Dahou, A., Webb, J., et al. Self-expanding Portico valve versus balloon-expandable SAPIEN XT valve in patients with small aortic annuli: comparison of hemodynamic performance. Rev Esp Cardiol 69 (2016), 501–508.
12. Wilson, A., Cabau, J., Wood, D., et al. Transcatheter aortic valve replacement with the St. Jude Medical Portico valve: first human experience. J Am Coll Cardiol 60 (2012), 581–586.
13. Manoharan, G., Linke, A., Moellmann, H., et al. Multicentre clinical study evaluating a novel resheathableannular functioning self-expanding transcatheter aortic valve system: safety and performance results at 30 days with the Portico system. EuroIntervention 12 (2016), 768–774.
14. O'Brien, S., Shahian, D., Filardo, G., et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2—isolated valve surgery. Ann Thorac Surg 88 (2009), S23–S42.
15. Roques, F., Michel, P., Goldstone, A., Nashef, S., The logistic EuroSCORE. Eur Heart J 24 (2003), 881–882.
16. Nashef, S., Roques, F., Sharples, L., et al. EuroSCORE II. Eur J Cardiothorac Surg 41 (2012), 734–744.
17. Afilalo, J., Eisenberg, M.M.J., Morin, J.-F., et al. Gait speed as an incremental predictor of mortality and major morbidity in elderly patients undergoing cardiac surgery. J Am Coll Cardiol 56 (2010), 1668–1676.
18. Bohannon, R., Bear-Lehman, J., Desrosiers, J., Massy-Westropp, N., Mathiowetz, V., Average grip strength: a meta-analysis of data obtained with a Jamar dynamometer from individuals 75 years or more of age. J Geriatr Phys Ther 30 (2007), 28–30.
19. Katz, S., Ford, A., Moskowitz, R., Jackson, B., Jaffe, M., Studies of illness in the aged. The index of ADL: a standardized measure of biological and psychosocial function. JAMA, 185, 1963, 914.
20. Leon, M., Piazza, N., Nikolsky, E., et al. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol 57 (2001), 253–269.
21. Popma, J., Adams, D., Reardon, M.J., et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol 63 (2014), 1972–1981.
22. Meredith, I., Walters, D., Dumonteil, N., et al. 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 64 (2014), 1339–1348.
23. Webb, J., Gerosa, G., Lefèvre, T., et al. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol 64 (2014), 2235–2243.
24. Manoharan, G., Walton, A., Brecker, S., et al. Treatment of symptomatic severe aortic stenosis with a novel resheathable supra-annular self-expanding transcatheter aortic valve system. J Am Coll Cardiol Intv 8 (2015), 1359–1367.
25. Schofer, J., Colombo, A., Klugmann, S., et al. Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve. J Am Coll Cardiol 63 (2014), 763–768.
26. Généreux, P., Head, S., Van Mieghem, N., et al. Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions: a weighted meta-analysis of 3,519 patients from 16 studies. J Am Coll Cardiol 59 (2012), 2317–2326.
27. Kodali, S., Williams, M., Smith, C., et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 366 (2012), 1686–1695.
28. Webb, J., Doshi, D., Mack, M., et al. A randomized evaluation of the SAPIEN XT transcatheter heart valve system in patients with aortic stenosis who are not candidates for surgery. J Am Coll Cardiol Intv 8 (2015), 1797–1806.
29. Gremeaux, V., Troisgros, O., Benaim, S., et al. Determining the minimal clinically important difference for the six-minute walk test and the 200-meter fast-walk test during cardiac rehabilitation program in coronary artery disease patients after acute coronary syndrome. Arch Phys Med Rehabil 92 (2011), 611–618.