Transcatheter or surgical aortic-valve replacement in intermediate-risk patients

New England Journal of Medicine

Volumn 374, Issue 17, 2016, Pages 1609-1620

  Leon, Martin B ^a   Smith, Craig R ^a   Mack, Michael J ^a,c   Makkar, Raj R ^d   Svensson, Lars G ^g   Kodali, Susheel K ^a   Thourani, Vinod H ^h   Tuzcu, E Murat ^g   Miller, D Craig ^e   Herrmann, Howard C ⁱ   Doshi, Darshan ^a   Cohen, David J ^j   Pichard, Augusto D ^l   Kapadia, Samir ^g   Dewey, Todd ^m   Babaliaros, Vasilis ^h   Szeto, Wilson Y ⁱ   Williams, Mathew R ^b   Kereiakes, Dean ⁿ   Zajarias, Alan ^k   Greason, Kevin L ^o   Whisenant, Brian K ^p   Hodson, Robert W ^q   Moses, Jeffrey W ^a   Trento, Alfredo ^d   Brown, David L ^c   Fearon, William F ^e   Pibarot, Philippe ^r   Hahn, Rebecca T ^a   Jaber, Wael A ^g   Anderson, William N ^f   Alu, Maria C ^a   Webb, John G ^s   more..

^a Department of Medicine   (United States)

^b NEW YORK UNIVERSITY MEDICAL CENTER   (United States)

^c SCOTT AND WHITE MEMORIAL HOSPITAL   (United States)

^d CEDARS SINAI MEDICAL CENTER   (United States)

^e STANFORD UNIVERSITY   (United States)

^f Cleveland Clinic ^*  (United States)

^g LERNER RESEARCH INSTITUTE   (United States)

^h EMORY UNIVERSITY   (United States)

ⁱ UNIVERSITY OF PENNSYLVANIA   (United States)

^j St Luke's Mid America Heart Institute   (United States)

^k WASHINGTON UNIVERSITY   (United States)

^l WASHINGTON HOSPITAL CENTER   (United States)

^m HOSPITAL CORPORATION OF AMERICA   (United States)

ⁿ Christ Hospital   (United States)

^o MAYO CLINIC   (United States)

^p INTERMOUNTAIN MEDICAL CENTER   (United States)

^q PROVIDENCE ST VINCENT MEDICAL CENTER   (United States)

^r UNIVERSITÉ LAVAL   (Canada)

^s ST PAUL S HOSPITAL   (Canada)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; HEPARIN;

ACUTE KIDNEY FAILURE; AGED; AORTA STENOSIS; AORTA VALVE REGURGITATION; AORTA VALVE REPLACEMENT; ARTICLE; ATRIAL FIBRILLATION; BALLOON EXPANDABLE SAPIEN XT HEART VALVE PROSTHESIS; BLEEDING; BODY MASS; CANADA; COHORT ANALYSIS; CONTROLLED STUDY; DISEASE CLASSIFICATION; DISEASE SEVERITY; ECHOCARDIOGRAPHY; FEMALE; HEART LEFT VENTRICLE EJECTION FRACTION; HEART VALVE PROSTHESIS; HUMAN; INTENSIVE CARE UNIT; MAJOR CLINICAL STUDY; MALE; MITRAL VALVE REGURGITATION; NEW YORK HEART ASSOCIATION CLASS; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SOCIETY OF THORACIC SURGEONS SCORE; SURGICAL APPROACH; SURGICAL TECHNIQUE; TRANSCATHETER AORTIC VALVE IMPLANTATION; UNITED STATES; VERY ELDERLY; AORTIC VALVE STENOSIS; CLINICAL TRIAL; COMPARATIVE STUDY; ECHOGRAPHY; HEART VALVE REPLACEMENT; KAPLAN MEIER METHOD; MORTALITY; MULTICENTER STUDY; MULTIVARIATE ANALYSIS; POSTOPERATIVE COMPLICATION; PROCEDURES; RISK FACTOR; STROKE;

AGED; AGED, 80 AND OVER; AORTIC VALVE STENOSIS; FEMALE; HEART VALVE PROSTHESIS; HEART VALVE PROSTHESIS IMPLANTATION; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MULTIVARIATE ANALYSIS; POSTOPERATIVE COMPLICATIONS; RISK FACTORS; STROKE; TRANSCATHETER AORTIC VALVE REPLACEMENT;

EID: 84964932839     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1514616     Document Type: Article

References (40)

1. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010; 363: 1597-607.
2. Popma JJ, Adams DH, Reardon MJ, 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 2014; 63: 1972-81.
3. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011; 364: 2187-98.
4. Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 2014; 370: 1790-8.
5. The Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC), the European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012). Eur Heart J 2012; 33: 2451-96.
6. Nishimura RA, Otto CM, Bonow RO, 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. J Am Coll Cardiol 2014; 63(22): e57-185.
7. Généreux P, Webb JG, Svensson LG, et al. Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of AoRTic TraNscathetER Valve) trial. J Am Coll Cardiol 2012; 60: 1043-52.
8. Kahlert P, Knipp SC, Schlamann M, et al. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study. Circulation 2010; 121: 870-8.
9. Siontis GC, Jüni P, Pilgrim T, et al. Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR: a meta-analysis. J Am Coll Cardiol 2014; 64: 129-40.
10. Hamm CW, Möllmann H, Holzhey D, et al. The German Aortic Valve Registry (GARY): in-hospital outcome. Eur Heart J 2014; 35: 1588-98.
11. Tamburino C, Barbanti M, D'Errigo P, et al. 1-Year outcomes after transfemoral transcatheter or surgical aortic valve replacement: results from the Italian OBSERVANT Study. J Am Coll Cardiol 2015; 66: 804-12.
12. Thyregod HG, Steinbrüchel DA, Ihlemann N, et al. Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis: 1-year results from the all-comers NOTION randomized clinical trial. J Am Coll Cardiol 2015; 65: 2184-94.
13. Piazza N, Kalesan B, van Mieghem N, et al. A 3-center comparison of 1-year mortality outcomes between transcatheter aortic valve implantation and surgical aortic valve replacement on the basis of propensity score matching among intermediate-risk surgical patients. JACC Cardiovasc Interv 2013; 6: 443-51.
14. Wenaweser P, Stortecky S, Schwander S, et al. Clinical outcomes of patients with estimated low or intermediate surgical risk undergoing transcatheter aortic valve implantation. Eur Heart J 2013; 34: 1894-905.
15. Latib A, Maisano F, Bertoldi L, et al. Transcatheter vs surgical aortic valve replacement in intermediate-surgical-risk patients with aortic stenosis: a propensity score-matched case-control study. Am Heart J 2012; 164: 910-7.
16. D'Errigo P, Barbanti M, Ranucci M, et al. Transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis: results from an intermediate risk propensity-matched population of the Italian OBSERVANT study. Int J Cardiol 2013; 167: 1945-52.
17. Schymik G, Heimeshoff M, Bramlage P, et al. A comparison of transcatheter aortic valve implantation and surgical aortic valve replacement in 1,141 patients with severe symptomatic aortic stenosis and less than high risk. Catheter Cardiovasc Interv 2015; 86: 738-44.
18. Thourani VH, Suri RM, Gunter RL, et al. Contemporary real-world outcomes of surgical aortic valve replacement in 141,905 low-risk, intermediate-risk, and high-risk patients. Ann Thorac Surg 2015; 99: 55-61.
19. O'Brien SM, Shahian DM, Filardo G, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models. 2. Isolated valve surgery. Ann Thorac Surg 2009; 88: Suppl 1: S23-42.
20. Webb JG, Altwegg L, Masson JB, Al Bugami S, Al Ali A, Boone RA. A new transcatheter aortic valve and percutaneous valve delivery system. J Am Coll Cardiol 2009; 53: 1855-8.
21. Webb JG, Doshi D, Mack MJ, et al. A randomized evaluation of the SAPIEN XT transcatheter heart valve system in patients with aortic stenosis who are not candidates for surgery. JACC Cardiovasc Interv 2015; 8: 1797-806.
22. Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol 2012; 60: 1438-54.
23. Pibarot P, Hahn RT, Weissman NJ, Monaghan MJ. Assessment of paravalvular regurgitation following TAVR: a proposal of unifying grading scheme. JACC Cardiovasc Imaging 2015; 8: 340-60.
24. Mack MJ, Brennan JM, Brindis R, et al. Outcomes following transcatheter aortic valve replacement in the United States. JAMA 2013; 310: 2069-77.
25. Moat NE, Ludman P, de Belder MA, et al. Long-term outcomes after transcatheter aortic valve implantation in highrisk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol 2011; 58: 2130-8.
26. Mohr FW, Holzhey D, Möllmann H, et al. The German Aortic Valve Registry: 1-year results from 13,680 patients with aortic valve disease. Eur J Cardiothorac Surg 2014; 46: 808-16.
27. Athappan G, Gajulapalli RD, Sengodan P, et al. Influence of transcatheter aortic valve replacement strategy and valve design on stroke after transcatheter aortic valve replacement: a meta-analysis and systematic review of literature. J Am Coll Cardiol 2014; 63: 2101-10.
28. Blackstone EH, Suri RM, Rajeswaran J, et al. Propensity-matched comparisons of clinical outcomes after transapical or transfemoral transcatheter aortic valve replacement: a Placement of Aortic Transcatheter Valves (PARTNER)-I trial substudy. Circulation 2015; 131: 1989-2000.
29. Pibarot P, Weissman NJ, Stewart WJ, et al. Incidence and sequelae of prosthesispatient mismatch in transcatheter versus surgical valve replacement in high-risk patients with severe aortic stenosis: a PARTNER Trial Cohort A analysis. J Am Coll Cardiol 2014; 64: 1323-34.
30. Kodali SK, Williams MR, Smith CR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012; 366: 1686-95.
31. Généreux P, Cohen DJ, Williams MR, et al. Bleeding complications after surgical aortic valve replacement compared with transcatheter aortic valve replacement: insights from the PARTNER I Trial (Placement of Aortic Transcatheter Valve). J Am Coll Cardiol 2014; 63: 1100-9.
32. Brennan JM, Edwards FH, Zhao Y, O'Brien SM, Douglas PS, Peterson ED. Long-term survival after aortic valve replacement among high-risk elderly patients in the United States: insights from the Society of Thoracic Surgeons Adult Cardiac Surgery Database, 1991 to 2007. Circulation 2012; 126: 1621-9.
33. Holzhey D, Mohr FW, Walther T, et al. Current results of surgical aortic valve replacement: Insights from the German Aortic Valve Registry. Ann Thorac Surg 2016; 101: 658-66.
34. Shahian DM, O'Brien SM, Filardo G, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models. 3. Valve plus coronary artery bypass grafting surgery. Ann Thorac Surg 2009; 88: 1 Suppl: S43-62.
35. Binder RK, Rodés-Cabau J, Wood DA, et al. Transcatheter aortic valve replacement with the SAPIEN 3: a new balloonexpandable transcatheter heart valve. JACC Cardiovasc Interv 2013; 6: 293-300.
36. Kodali S, Thourani VH, White J, et al. Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk, and intermediate-risk patients with aortic stenosis. Eur Heart J 2016 (in press).
37. Jilaihawi H, Kashif M, Fontana G, et al. Cross-sectional computed tomographic assessment improves accuracy of aortic annular sizing for transcatheter aortic valve replacement and reduces the incidence of paravalvular aortic regurgitation. J Am Coll Cardiol 2012; 59: 1275-86.
38. Makkar RR, Fontana G, Jilaihawi H, et al. Possible subclinical leaflet thrombosis in bioprosthetic aortic valves. N Engl J Med 2015; 373: 2015-24.
39. Kapadia SR, Leon MB, Makkar RR, et al. 5-Year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet 2015; 385: 2485-91.
40. Mack MJ, Leon MB, Smith CR, et al. 5-Year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet 2015; 385: 2477-84.