Clinical practice change requires more than comparative effectiveness evidence: Abdominal aortic aneurysm management in the USA

Journal of Comparative Effectiveness Research

Volumn 1, Issue 1, 2012, Pages 31-44

  Ballard, David J ^a   Filardo, Giovanni ^a,b,c   Graca, Briget Da ^a   Powell, Janet T ^d  

^a BAYLOR HEALTH CARE SYSTEM   (United States)

^b SOUTHERN METHODIST UNIVERSITY   (United States)

^c University of Louisville School of Medicine   (United States)

^d IMPERIAL COLLEGE LONDON   (United Kingdom)

Author keywords

abdominal aortic aneurysm; comparative effectiveness; cost effectiveness; endovascular repair; open surgical repair

Indexed keywords

ABDOMINAL AORTA ANEURYSM; ANEURYSM DIAMETER; ANEURYSM SURGERY; CANADA; CLINICAL COMPETENCE; CLINICAL PRACTICE; COMPARATIVE EFFECTIVENESS; COST EFFECTIVENESS ANALYSIS; DISEASE SURVEILLANCE; ELECTIVE SURGERY; ENDOVASCULAR ANEURYSM REPAIR; EVIDENCE BASED PRACTICE; HEALTH CARE COST; HEALTH CARE POLICY; HEALTH CARE QUALITY; HEALTH CARE UTILIZATION; HIGH RISK PATIENT; HUMAN; LONG TERM SURVIVAL; OPEN SURGICAL ANEURYSM REPAIR; PATIENT MONITORING; PATIENT PREFERENCE; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REIMBURSEMENT; REOPERATION; REVIEW; SURGICAL MORTALITY; SURGICAL RISK; TREATMENT OUTCOME; UNITED STATES;

EID: 84875466944     PISSN: 20426305     EISSN: 20426313     Source Type: Journal    
DOI: 10.2217/cer.11.6     Document Type: Review

References (74)

1. Iglehart JK. Prioritizing comparative-effectiveness research - IOM recommendations. N. Engl. J. Med. 361(4), 325-328 (2009).
2. Glasgow JM, Scott-Caziewell JR, Kaboli PJ. Guiding inpatient quality improvement: a systematic review of lean and six sigma. Jt Comm. J. Qual. Patient Saf. 36(12), 533-540 (2010).
3. Lederle FA, Johnson GR, Wilson SE et al. Prevalence and associations of abdominal aortic aneurysm detected through screening. Aneurysm Detection and Management (ADAM) Veterans Affairs Cooperative Study Group. Ann. Intern. Med. 126(6), 441-449 (1997).
4. Howden LM, Meyer JA. Age and sex composition: 2010. In: 2010 Census Briefs. Howden LM, Meyer JA (Eds). US Census Bureau (2011).
5. Gillum RF. Epidemiology of aortic aneurysm in the United States. J. Clin. Epidemiol. 48(11), 1289-1298 (1995).
6. Wilt TJ, Lederle FA, MacDonald R, Jonk YC, Rector TS, Kabe RL. Comparison of Endovascular and Open Surgical Repairs for Abdominal Aortic Aneurysm. Agency for Healthcare Research and Quality, Rockville, MD, USA (2006).
7. Schwarze ML, Shen Y, Hemmerich J, Dale W. Age-related trends in utilization and outcome of open and endovascular repair for abdominal aortic aneurysm in the United States, 2001-2006. J. Vasc. Surg. 50(4), 722e2-729e2 (2009).
8. Chaikof EL, Brewster DC, Dalman RL et al. SVS practice guidelines for the care of patients with an abdominal aortic aneurysm: executive summary. J. Vasc. Surg. 50(4), 880-896 (2009).
9. Rutherford RB. Management of abdominal aortic aneurysms: which risk factors play a role in decision-making? Semin. Vasc. Surg. 21(3), 124-131 (2008).
10. Miyake T, Morishita R. Pharmacological treatment of abdominal aortic aneurysm. Cardiovasc. Res. 83(3), 436-443 (2009).
11. Elkouri S, Martelli E, Gloviczki P et al. Most patients with abdominal aortic aneurysm are not suitable for endovascular repair using currently approved bifurcated stent-grafts. Vasc. Endovascular Surg. 38(5), 401-412 (2004).
12. Brooks MJ, Brown LC, Greenhalgh RM. Defining the role of endovascular therapy in the treatment of abdominal aortic aneurysm: results of a prospective randomized trial. Adv. Surg. 40, 191-204 (2006).
13. Dillavou ED, Muluk SC, Makaroun MS. Improving aneurysm-related outcomes: nationwide benefits of endovascular repair. J. Vasc. Surg. 43(3), 446-451, discussion 451-442 (2006).
14. Redberg RF. Squandering medicare's money. New York Times. New York, NY, USA (2011).
15. Brown PM, Zelt DT, Sobolev B. The risk of rupture in untreated aneurysms: the impact of size, gender, and expansion rate. J. Vasc. Surg. 37(2), 280-284 (2003).
16. Runge M, Stouffer G, Patterson C. Netter's Cardiology. Saunders/Elsevier, Philadelphia, PA, USA (2010).
17. Andrews SM, Cuming R, Macsweeney ST, Barrett NK, Greenhalgh RM, Nott DM. Assessment of feasibility for endovascular prosthetic tube correction of aortic aneurysm. Br. J. Surg. 82(7), 917-919 (1995).
18. Yusuf SW, Baker DM, Hind RE et al. Endoluminal transfemoral abdominal aortic aneurysm repair with aorto-uni-iliac graft and femorofemoral bypass. Br. J. Surg. 82(7), 916 (1995).
19. Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR Trial 1), 30 day operative mortality results: randomized controlled trial. Lancet 364(9437), 843-848 (2004).
20. Timaran CH, Rosero EB, Smith ST, Modrall JG, Valentine RJ, Clagett GP. Influence of age, aneurysm size, and patient fitness on suitability for endovascular aortic aneurysm repair. Ann. Vasc. Surg. 22(6), 730-735 (2008).
21. Simons P, van Overhagen H, Nawijn A, Bruijninckx B, Knippenberg B. Endovascular aneurysm repair with a bifurcated endovascular graft at a primary referral center: influence of experience, age, gender, and aneurysm size on suitability. J. Vasc. Surg. 38(4), 758-761 (2003).
22. Woodburn KR, Chant H, Davies JN, Blanshard KS, Travis SJ. Suitability for endovascular aneurysm repair in an unselected population. Br. J. Surg. 88(1), 77-81 (2001).
23. Brown LC, Greenhalgh RM, Powell JT, Thompson SG. Use of baseline factors to predict complications and reinterventions after endovascular repair of abdominal aortic aneurysm. Br. J. Surg. 97(8), 1207-1217 (2010).
24. Conners MS 3rd, Sternbergh WC 3rd, Carter G, Tonnessen BH, Yoselevitz M, Money SR. Endograft migration one to four years after endovascular abdominal aortic aneurysm repair with the AneuRx device: a cautionary note. J. Vasc. Surg. 36(3), 476-484 (2002).
25. Lederle FA, Freischlag JA, Kyriakides TC et al. Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial. JAMA 302(14), 1535-1542 (2009).
26. Becquemin JP, Kelley L, Zubilewicz T, Desgranges P, Lapeyre M, Kobeiter H. Outcomes of secondary interventions after abdominal aortic aneurysm endovascular repair. J. Vasc. Surg. 39(2), 298-305 (2004).
27. Conrad MF, Crawford RS, Pedraza JD et al. Long-term durability of open abdominal aortic aneurysm repair. J. Vasc. Surg. 46(4), 669-675 (2007).
28. Darling RC, Messina CR, Brewster DC, Ottinger LW. Autopsy study of unoperated abdominal aortic aneurysms. The case for early resection. Circulation 56(Suppl. 3), II161-II164 (1977).
29. Nevitt MP, Ballard DJ, Hallett JW Jr. Prognosis of abdominal aortic aneurysms. A population-based study. N. Engl. J. Med. 321(15), 1009-1014 (1989).
30. Simao da Silva E, Rodrigues AJ, Magalhaes Castro de Tolosa E, Rodrigues CJ, Villas Boas do Prado G, Nakamoto JC. Morphology and diameter of infrarenal aortic aneurysms: a prospective autopsy study. Cardiovasc. Surg. 8(7), 526-532 (2000).
31. Ashleigh RJ. Emergency EVAR: the challenging anatomy of ruptured abdominal aortic aneurysm. In: CIRSE. Munich, Germany (2011).
32. Lederle FA, Wilson SE, Johnson GR et al. Immediate repair compared with surveillance of small abdominal aortic aneurysms. N. Engl. J. Med. 346(19), 1437-1444 (2002).
33. Powell JT. Final 12 year follow-up of surgery versus surveillance in the UK small aneurysm trial: UK small aneurysm trial participants. Br. J. Surg. 94(6), 702-708 (2007).
34. The United Kindom Small Aneurysm Trial Participants. Long-term outcomes of immediate repair compared with surveillance of small abdominal aortic aneurysms. N. Engl. J. Med. 346(19), 1445-1452 (2002).
35. The United Kingdom Small Aneurysm Trial Participants. Mortality results for randomized controlled trial of early elective surgery or ultrasonographic surveillance for small abdominal aortic aneurysms. Lancet 352, 1649-1655 (1998).
36. Ouriel K. The PIVOTAL study: a randomized comparison of endovascular repair versus surveillance in patients with smaller abdominal aortic aneurysms. J. Vasc. Surg. 49(1), 266-269 (2009).
37. Ouriel K, Clair DG, Kent KC, Zarins CK. Endovascular repair compared with surveillance for patients with small abdominal aortic aneurysms. J. Vasc. Surg. 51(5), 1081-1087 (2010).
38. Cao P. Comparison of surveillance vs aortic endografting for small aneurysm repair (CAESAR) trial: study design and progress. Eur. J. Vasc. Endovasc. Surg. 30(3), 245-251 (2005).
39. Cao P, De Rango P, Verzini F, Parlani G, Romano L, Cieri E. Comparison of surveillance versus aortic endografting for small aneurysm repair (CAESAR): results from a randomized trial. Eur. J. Vasc. Endovasc. Surg. 41(1), 13-25 (2011).
40. Ballard DJ, Etachason JA, Hilborne LH et al. Abdominal Aortic Aneurysm Surgery: A Literature Review and Ratings of Appropriateness and Necessity. RAND Corporation, Santa Monica, CA, USA (1992).
41. Schanzer A, Greenberg RK, Hevelone N et al. Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair. Circulation 123(24), 2848-2855 (2011).
42. Paraskevas KI, Mikhailidis DP, Veith FJ. The rationale for lowering the size threshold in elective endovascular repair of abdominal aortic aneurysm. J. Endovasc. Ther. 18(3), 308-313 (2011).
43. Jim J, Rubin BG, Geraghty PJ, Criado FJ, Sanchez LA. Outcome of endovascular repair of small and large abdominal aortic aneurysms. Ann. Vasc. Surg. 25(3), 306-314 (2011).
44. Leurs LJ, Hobo R, Buth J. The multicenter experience with a third-generation endovascular device for abdominal aortic aneurysm repair. A report from the EUROSTAR database. J. Cardiovasc. Surg. (Torino) 45(4), 293-300 (2004).
45. Buth J, Laheij RJ. Early complications and endoleaks after endovascular abdominal aortic aneurysm repair: report of a multicenter study. J. Vasc. Surg. 31(Pt 1), 134-146 (2000).
46. May J, White GH, Waugh R et al. Comparison of first- and second-generation prostheses for endoluminal repair of abdominal aortic aneurysms: a 6 year study with life table analysis. J. Vasc. Surg. 32(1), 124-129 (2000).
47. Collin J, Murie JA. Endovascular treatment of abdominal aortic aneurysm: a failed experiment. Br. J. Surg. 88(10), 1281-1282 (2001).
48. Becquemin JP, Pillet JC, Lescalie F et al. A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients. J. Vasc. Surg. 53(5), 1167e1-1173e1 (2011).
49. Prinssen M, Verhoeven EL, Buth J et al. A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N. Engl. J. Med. 351(16), 1607-1618 (2004).
50. Blankensteijn JD, de Jong SE, Prinssen M et al. Two-year outcomes after conventional or endovascular repair of abdominal aortic aneurysms. N. Engl. J. Med. 352(23), 2398-2405 (2005).
51. De Bruin JL, Baas AF, Buth J et al. Long-term outcome of open or endovascular repair of abdominal aortic aneurysm. N. Engl. J. Med. 362(20), 1881-1889 (2010).
52. Greenhalgh RM, Brown LC, Powell JT, Thompson SG, Epstein D, Sculpher MJ. Endovascular versus open repair of abdominal aortic aneurysm. N. Engl. J. Med. 362(20), 1863-1871 (2010).
53. Greenhalgh RM, Brown LC, Powell JT, Thompson SG, Epstein D, Sculpher MJ. Endovascular versus open repair of abdominal aortic aneurysm. N. Engl. J. Med. 362(20), 1863-1871 (2010).
54. Prinssen M, Buskens E, de Jong SE et al. Cost-effectiveness of conventional and endovascular repair of abdominal aortic aneurysms: results of a randomized trial. J. Vasc. Surg. 46(5), 883-890 (2007).
55. Epstein DM, Sculpher MJ, Manca A et al. Modeling the long-term cost-effectiveness of endovascular or open repair for abdominal aortic aneurysm. Br. J. Surg. 95(2), 183-190 (2008).
56. Patel ST, Haser PB, Bush HL Jr, Kent KC. The cost-effectiveness of endovascular repair versus open surgical repair of abdominal aortic aneurysms: a decision analysis model. J. Vasc. Surg. 29(6), 958-972 (1999).
57. Bosch JL, Kaufman JA, Beinfeld MT, Adriaensen ME, Brewster DC, Gazelle GS. Abdominal aortic aneurysms: cost- effectiveness of elective endovascular and open surgical repair. Radiology 225(2), 337-344 (2002).
58. Tarride JE, Blackhouse G, De Rose G et al. Should endovascular repair be reimbursed for low risk abdominal aortic aneurysm patients? Evidence from Ontario, Canada. Int. J. Vasc. Med. 2011, 308685 (2011).
59. Jetty P, Hebert P, van Walraven C. Long-term outcomes and resource utilization of endovascular versus open repair of abdominal aortic aneurysms in Ontario. J. Vasc. Surg. 51(3), 577-583, 583 e1-3 (2010).
60. HR 3590. The Patient Protection and Affordable Care Act (PPACA) of 2010. Public Law 111-148. 124 Stat. 119. March 23, 2011. US Government Printing Office, Washington, DC, USA (2011).
61. Wolff KS, Prusa AM, Polterauer P et al. Endografting increases total volume of AAA repairs but not at the expense of open surgery: experience in more than 1000 patients. J. Endovasc. Ther. 12(3), 274-279 (2005).
62. Ramaiah VG, Westerband A, Thompson C et al. The AneuRx stent-graft since FDA approval: single-center experience of 230 cases. J. Endovasc. Ther. 9(4), 464-469 (2002).
63. Sternbergh WC, Nordness PJ, York JW, Conners MS, Carter G, Money SR. Endo-exuberance to endo-reality: trends in the management of 431 AAA repairs between 1996 and 2002. J. Endovasc. Ther. 10(3), 418-423 (2003).
64. Reise JA, Sheldon H, Earnshaw J et al. Patient preference for surgical method of abdominal aortic aneurysm repair: postal survey. Eur. J. Vasc. Endovasc. Surg. 39(1), 55-61 (2010).
65. Winterborn RJ, Amin I, Lyratzopoulos G, Walker N, Varty K, Campbell WB. Preferences for endovascular (EVAR) or open surgical repair among patients with abdominal aortic aneurysms under surveillance. J. Vasc. Surg. 49(3), 576e3- 581e3 (2009).
66. Reise JA, Sheldon H, Earnshaw J et al. Patient preference for surgical method of abdominal aortic aneurysm repair: postal survey. Eur. J. Vasc. Endovasc. Surg. 39(1), 55-61 (2010).
67. Martin JD, Warble PB, Hupp JA et al. A real world analysis of payment per unit time in a Maryland Vascular Practice. J. Vasc. Surg. 52(4), 1094-1098, discussion 1098-1099 (2010).
68. Adelman MA, Rockman CB, Lamparello PJ et al. Endovascular abdominal aortic aneurysm (AAA) repair since the FDA approval. Are we going too far? J. Cardiovasc. Surg. (Torino) 43(3), 359-367 (2002). 84 15 years of monitoring and one simple conclusion: don't expect sales representatives to help improve healthcare quality. Prescrire Int. 15(84), 154-159 (2006).
69. Lexchin J. What information do physicians receive from pharmaceutical representatives? Can. Fam. Physician 43, 941-945 (1997).
70. Lexchin J. Interactions between physicians and the pharmaceutical industry: what does the literature say? CMAJ 149, 1401-1407 (1993).
71. Ziegler MG, Lew P, Singer BC. The accuracy of drug information from pharmaceutical sales representatives. JAMA 273, 1296-1298 (1995).
72. Keyhani S, Siu AL. The underuse of overuse research. Health Serv. Res. 43(6), 1923-1930 (2008).
73. Forbes TL, Lawlor DK, Derose G, Harris KA. National audit of the recent utilization of endovascular abdominal aortic aneurysm repair in Canada: 2003 to 2004. J. Vasc. Surg. 42(3), 410-414 (2005).
74. Brook RH. Is choice of physician and hospital an essential benefit? JAMA 305(2), 195-196 (2011).