Medical Policy Title: Percutaneous Transluminal Endovascular Graft for Abdominal Aortic Aneurysm

Transcription

1 ARBenefits Apprval: 10/19/2011 Effective Date: 01/01/2012 Revisin Date: Cde(s): Medical Plicy Title: Percutaneus Transluminal Endvascular Graft fr Abdminal Artic Aneurysm Dcument: ARB Endvascular repair f infrarenal abdminal artic aneurysm r dissectin; using art-artic tube prsthesis Endvascular repair f infrarenal abdminal artic aneurysm r dissectin; using mdular bifurcated prsthesis (ne dcking limb) Endvascular repair f infrarenal abdminal artic aneurysm r dissectin; using mdular bifurcated prsthesis (tw dcking limbs) Endvascular repair f infrarenal abdminal artic aneurysm r dissectin; using unibdy bifurcated prsthesis Endvascular repair f infrarenal abdminal artic aneurysm r dissectin; using art-uniiliac r artunifemral prsthesis Open femral artery expsure fr delivery f endvascular prsthesis, by grin incisin, unilateral Placement f femral-femral prsthetic graft during endvascular artic aneurysm repair (List separately in additin t cde fr primary prcedure) Open iliac artery expsure fr delivery f endvascular prsthesis r iliac cclusin during endvascular therapy, by abdminal r retrperitneal incisin, unilateral Placement f prximal r distal extensin prsthesis fr endvascular repair f infrarenal abdminal artic r iliac aneurysm, false aneurysm, r dissectin; initial vessel Placement f prximal r distal extensin prsthesis fr endvascular repair f infrarenal abdminal artic r iliac aneurysm, false aneurysm, r dissectin; each additinal vessel (List separately in additin t cde fr primary prcedure) Open repair f infrarenal artic aneurysm r dissectin, plus repair f assciated arterial trauma, fllwing unsuccessful endvascular repair; tube prsthesis Open repair f infrarenal artic aneurysm r dissectin, plus repair f assciated arterial trauma, fllwing unsuccessful endvascular repair; art-biiliac prsthesis Open repair f infrarenal artic aneurysm r dissectin, plus repair f assciated arterial trauma, fllwing unsuccessful endvascular repair; art-bifemral prsthesis Endvascular repair f infrarenal abdminal artic aneurysm r dissectin, radilgical supervisin and interpretatin Placement f prximal r distal extensin prsthesis fr endvascular repair f infrarenal artic r iliac artery aneurysm, pseudaneurysm, r dissectin, radilgical supervisin and interpretatin Administered by: QualChice reserves the right t alter, amend, change r supplement medical plicies as needed. QualChice reviews and authrizes services and substances. CPT and HCPCS cdes are listed as a cnvenience and any Page 1 f 9

2 Public Statement: Cnventinal management f a clinically significant abdminal artic aneurysm cnsists f surgical excisin with placement f a sutured wven graft. Endvascular prstheses, a minimally invasive, catheter-based alternative, has been develped t avid the high mrtality assciated with the pen surgical excisin f an abdminal artic aneurysm. Medical Plicy Statement: Endprstheses f abdminal artic aneurysms is cnsidered medically necessary fr the treatment f abdminal artic aneurysms in any f the fllwing clinical situatins: an aneurysmal diameter greater than 5.0 cm an aneurysmal diameter f cm that has increased in size by 0.5 cm in the last 6 mnths an aneurysmal diameter that measures twice the size f the nrmal infrarenal arta a ruptured abdminal artic aneurysm Nte: Fr treatment f ruptured abdminal artic aneurysm with endprstheses the patient must be sufficiently stable t underg detailed CT examinatin fr anatmic measurements, the aneurysm shuld be anatmically apprpriate fr endvascular repair, and specialized persnnel shuld be available. Individual cnsideratin fr cverage is extended fr aneurysms smaller than five cm in wmen r small individuals. Backgrund: EVAR as an alternative t pen repair fr elective treatment f AAAs Several RCTs cmpared utcmes f EVAR with pen repair fr elective treatment f AAAs. These studies generally crrbrated previus evidence n this questin, i.e., that early cmplicatins related t the prcedure are less with EVAR but that lng-term cmplicatins are mre cmmn with EVAR, and there is n difference in lng-term utcmes between the tw prcedures. The U.K. EVAR Investigatrs published a RCT f EVAR versus pen repair in patients wh were candidates fr pen repair (UK EVAR Trial Investigatrs, 2010). A ttal f 1,252 patients with aneurysms 5.5 cm r larger were randmized t EVAR r pen repair. The periperative mrtality was lwer in the EVAR grup cmpared t pen repair (1.8% vs. 4.3%, respectively; p=0.02). After 8 years f fllw-up, there was n difference in survival between the grups (HR: 1.03; 95% cnfidence interval [CI]: QualChice reserves the right t alter, amend, change r supplement medical plicies as needed. QualChice reviews and authrizes services and substances. CPT and HCPCS cdes are listed as a cnvenience and any Page 2 f 9

3 1.23). The authrs cncluded that the early survival advantage f EVAR was lst ver time due t late endgraft ruptures, which were ften fatal. De Bruin et al. randmized 351 patients with AAAs f at least 5 cm t EVAR r pen repair (De Bruin, 2010). The primary utcmes were all-cause mrtality and reinterventins. After 6 years f fllw-up, the survival rates were similar between the EVAR and pen repair grups (68.9% vs. 69.9%, respectively; 95% CI fr the difference: -8.8 t 10.8; p=0.97). Reinterventins were mre cmmn in the EVAR grup. Freedm frm reinterventins was 70.4% fr EVAR cmpared t 81.9% fr pen repair (95% CI fr difference: 2.0 t 21.0; p=0.03). Becquemin et al. perfrmed a RCT f EVAR versus pen repair in lw- t mderate-risk patients. Lw-t-mderate risk was defined by a scre f 0-2 n the cmrbidity scale f the Sciety f Vascular Surgery and by the lack f high-risk features n imaging (Becquemin, 2011). A ttal f 316 patients with aneurysms larger than 5 cm was randmized t EVAR r pen repair. In-hspital mrtality was lw fr bth the EVAR and pen repair grup, with n significant difference between grups (0.6% vs. 1.3%, respectively; p=1.0). At 3 years f fllw-up, there was n difference between the EVAR and pen grup in the percent f patients surviving free f majr adverse events (82.4% +/- 3.7% vs. 85.1% +/- 4.5%, respectively; p=0.09). Aneurysm-related mrtality als did nt differ between the EVAR and pen grups (4% vs. 0.7%, respectively; p=0.12). There were significantly mre reinterventins in the EVAR grup (16% vs. 2.4%, respectively; p<0.0001). EVAR as an alternative t pen repair fr ruptured aneurysms One cmparative, nnrandmized study was identified that cmpared EVAR and pen repair fr ruptured aneurysms at ne institutin. Ten Bsch et al perfrmed a retrspective cmparisn f 25 patients wh underwent EVAR with 79 patients wh underwent pen repair. EVAR was perfrmed if the EVAR-trained vascular surgen was n call and the patient was suitable fr EVAR; therwise pen repair was perfrmed (Ten Bsch, 2010). Periperative mrtality was 4.0% in the EVAR grup cmpared t 6.1% in the pen repair grup (p>0.99). At 30 days, mrtality was lwer fr the EVAR grup (20.0% vs. 45.5%, respectively; p=0.04), and this survival advantage was maintained at 6 mnths (28% vs. 54.5%, respectively; p=0.04). Median length f stay was als lwer with EVAR (9.5 days vs days, respectively, p=0.03). While this trial reprted superir utcmes fr the EVAR grup, it has several methdlgic limitatins and is therefre nt definitive fr establishing the superirity f EVAR. The study was retrspective, thus limiting the quality f the data available fr analysis. It was nnrandmized, with grup assignment based largely n surgen availability, and therefre prne t selectin bias. The baseline characteristics f patients shwed numerus numerical imbalances. There were small numbers f patients in the EVAR grup (n=25), and the grups were nt balanced in terms f numbers (25 vs. 79 in pen repair grup). The utcmes were analyzed in univariate fashin nly, there was n multivariate analysis. QualChice reserves the right t alter, amend, change r supplement medical plicies as needed. QualChice reviews and authrizes services and substances. CPT and HCPCS cdes are listed as a cnvenience and any Page 3 f 9

4 EVAR versus n surgery fr smaller aneurysms that d nt meet current size criteria fr surgery, r fr patients wh are ineligible fr pen surgery The Caesar trial cmpared the use f EVAR fr small AAAs, which did nt meet the current threshlds recmmended fr interventin, with active surveillance (Ca, 2011). The study enrlled 360 patients, yearsld, with aneurysms f cm. Patients were randmized t early EVAR treatment r surveillance by ultrasund and/r CT. In the surveillance grup, surgery was perfrmed nly after the AAA met current recmmendatins fr interventin (=5.5 cm, grwth 1 cm/year, r symptmatic). If repair was indicated, EVAR was perfrmed unless the anatmy f the AAA was unsuitable fr EVAR, in which case pen repair was perfrmed. Patients were fllwed fr a median f 32.4 mnths fr the primary utcme f all-cause mrtality. The primary utcme ccurred at a lwer rate than anticipated, thus limiting the pwer t detect a difference. At final fllw-up, there was n significant difference in the main endpint. Kaplan-Meier estimates f all-cause mrtality were 10.1% fr the surveillance grup cmpared with 14.5% fr the EVAR grup (HR 0.76; 95% CI: ). Aneurysm-related mrtality, aneurysm rupture, and majr mrbidity rates were als similar between grups. Fr patients in the surveillance grup, the Kaplan-Meier estimate f underging aneurysm repair was 59.7% at 36 mnths and 84.5% at 54 mnths. A secnd trial by Ouriel et al. randmly assigned 728 patients with AAAs f 4-5 cm t early EVAR r ultrasund surveillance (Ouriel, 2010). Patients were fllwed fr a mean 20 +/- 12 mnths fr the primary utcmes f aneurysm rupture, aneurysm-related death, and verall mrtality. At the final fllw-up, verall mrtality was the same in bth grups at a rate f 4.1%. Aneurysm rupture r aneurysm-related death ccurred at a lw rate and was als the same between grups at a rate f 0.6%. The hazard rati fr the primary utcme measures was 0.99 (95% CI: ). The U.K. EVAR Investigatrs published a RCT f EVAR versus n treatment f AAAs 5.5 cm r larger, but in whm surgery was nt an ptin due t prhibitive surgical risk r patient preference (UK EVAR Trial Investigatrs, 2010). A ttal f 404 patients were randmized t EVAR r n treatment. Periperative mrtality in the EVAR grup was 7.3%. After 8 years f fllw-up, aneurysm-related mrtality was lwer in the EVAR grup, but verall mrtality did nt differ (HR 0.99; 95% CI: ). There was a high rate f lng-term cmplicatins in the EVAR grup, with 48% f patients having a graft-related cmplicatin, and 27% f patients requiring reinterventin fr cmplicatins. Summary New evidence frm randmized, cntrlled trials cmparing EVAR t pen repair fr elective treatment f aneurysm crrbrates previus studies n this questin, with neither apprach being clearly superir t the ther. These trials reprt n lnger term utcmes, greater than 5 years after surgery, and cntinue t shw cmparable survival fr EVAR cmpared t pen repair at these lnger time pints. The early advantage f QualChice reserves the right t alter, amend, change r supplement medical plicies as needed. QualChice reviews and authrizes services and substances. CPT and HCPCS cdes are listed as a cnvenience and any Page 4 f 9

5 EVAR is balanced ut by the higher rate f lng-term cmplicatins. One trial f patients wh were f lw t mderate surgical risk reprted that the early benefit f EVAR was nt evident in this ppulatin. Several randmized, cntrlled trials have evaluated EVAR versus n surgical interventin in patients wh were nt eligible fr pen repair. These trials d nt reprt superir utcmes with EVAR and thus d nt supprt use f EVAR in these patients. One nnrandmized trial cmpared EVAR with pen repair fr ruptured aneurysms and reprted that survival at 30 days and 6 mnths was superir fr the EVAR grup. Hwever, this study had numerus methdlgic limitatins and is nt definitive fr establishing the superirity f EVAR. Technlgy Assessments, Guidelines, and Psitin Statements Guidelines fr the use f EVAR were develped jintly by the Sciety f Interventinal Radilgy, the Cardivascular and Interventinal Radilgical Sciety f Eurpe, and the Canadian Interventinal Radilgy Assciatin (Walker, 2010). These guidelines state that: Indicatins fr EVAR are currently the same as pen repair Patient preference fr EVAR versus pen repair shuld be cnsidered when apprpriate Endvascular abdminal artic aneurysm repair shuld be cnsidered as having an intermediate t high cardiac risk that ranges frm 3% t 7% There has been increasing use f EVAR fr ruptured aneurysms. Achieving ptimal EVAR results fr ruptured AAA requires establishment f a treatment prtcl invlving the emergency department, the endvascular team, anesthesilgy, and the perating rm persnnel Lifelng imaging surveillance f patients after EVAR is critical fr the detectin and, if pssible, the characterizatin f endleaks; evidence f expansin r shrinkage f the residual AAA sac thrugh measurement f aneurysm size, vlume calculatin, and identificatin f substantial changes in aneurysm dimensins; detectin f mechanical changes in the stent-graft, such as migratin, kinking, r fracture; and evaluatin f the lng-term perfrmance f the endprsthesis. QualChice reserves the right t alter, amend, change r supplement medical plicies as needed. QualChice reviews and authrizes services and substances. CPT and HCPCS cdes are listed as a cnvenience and any Page 5 f 9

6 References: Baum RA, Fairman RM, Mhler ER.(2009) Stent grafts fr abdminal artic aneurysms. UpTDate, Basw DS (Ed), Waltham, MA, Becquemin JP, Pillet JC, Lescalie F et al.(2011) A randmized cntrlled trial f endvascular aneurysm repair versus pen surgery fr abdminal artic aneurysms in lw- t mderate-risk patients. J Vasc Surg 2011 [Epub ahead f print]. Blankensteijn JD, de Jng SE, Prinssen M et al.(2005) Tw-year utcmes after cnventinal r endvascular repair f abdminal artic aneurysms. NEJM 2005; 352: Blum U, Vshage G,, et al. Lammer Jurnal.(1997) Endluminal stent-grafts fr infrarenal abdminal artic aneurysms. NEJM 1997; 336: Ca P, De Rang P, Verzini F et al.(2011) Cmparisn f surveillance versus artic endgrafting fr small aneurysm repair (CAESAR): results frm a randmized trial. Eur J Vasc Endvasc Surg 2011; 41(1): Ca P, Verzini F, Parlani G et al.(2004) Clinical effect f abdminal artic aneurysm endgrafting: 7 year cncurrent cmparisn with pen repair. J Vasc Surg 2004;40: Crnenwett JL, Seeger JM.(2004) Withdrawal f article by the FDA after bjectin frm Medtrnic. J Vasc Surg 2004;40:2009. De Bruin JL, Baas AF, Buth J et al.(2010) Lng-term utcme f pen r endvascular repair f abdminal artic aneurysm. N Engl J Med 2010;362: De Bruin JL, Baas AF, Buth J et al.(2010) Lng-term utcmes f pen r endvascular repair f abdminal artic aneurysm. N Engl J Med 2010; 362(20): Dilln M, Cardwell C, Blair PH et al.(2007) Endvascular treatment fr ruptured abdminal artic aneurysm. Cchrane Database Syst Rev 2007; (1):CD Egrva N, Giacvelli J, Grec G et al.(2008) Natinal utcmes fr the treatment f ruptured abdminal artic aneurysm: cmparisn f pen versus endvascular repairs. J Vasc Surg 2008; 48(5): Endvascular Repair f Abdminal Artic Aneurysm Blue Crss Blue Shield Assciatin Technlgy Evaluatin Center Assessment. Endvascular repair, abdminal artic aneurysms. Hayes Technlgy Assessment. Octber QualChice reserves the right t alter, amend, change r supplement medical plicies as needed. QualChice reviews and authrizes services and substances. CPT and HCPCS cdes are listed as a cnvenience and any Page 6 f 9

7 Ernst CB.(1997) Current therapy fr infrarenal artic aneurysms. NEJM 1997; 336: EVAR trial participants.(2005) Endvascular aneurysm repair and utcme in patients unfit fr pen repair f abdminal artic aneurysm (EVAR trial 2): randmised cntrlled trial. Lancet 2005; 365: EVAR trial participants.(2005) Endvascular aneurysm repair versus pen repair in patients with abdminal artic aneurysm (EVAR trial 1): randmised cntrlled trial. Lancet 2005; 365: Faries PL, Brener BJ, Cnnelly TL, et al.(2002) A multicenter experience with the Talent endvascular graft fr the treatment f abdminal artic aneurysms. J Vasc Surg 2002; 35(6): Gueffic Y, Becquemin JP, desgranges P et al.(2005) Midterm survival after endvascular versus pen repair f infrarenal artic aneurysms. J Endvasc Ther 2005;12: Harris PL, Vallabhaneni SR, Desgranges P et al.(2000) Incidence and risk factrs f late rupture, cnversin, and death after endvascular repair f infrarenal artic aneurysms: the EUROSTAR experience. J Vasc Surg 2000; 32: Hirsch AT, Haskal ZJ, Hertzer NR et al.(2006) ACC/AHA 2005 Practice Guidelines fr the management f patients with peripheral arterial disease(lwer extremity, renal, mesenteric, and abdminal artic). Circulatin 2006; 113:e463. Kent CK.(2010) Endvascular aneurysm repair-is it Durable? N Engl J Med 2010;362: Lindhlt, JS.(2004) Endvascular aneurysm repair. Lancet 2004; 364: Makarun MS, Chaikf E, Naslund T, et al.(2002) Efficacy f a bifurcated endgraft versus pen repair f abdminal artic aneurysms: a reappraisal. J Vasc Surg 2002; 35(2): McPhee J, Eslami MH, Arus EJ et al.(2009) Endvascular treatment f ruptured abdminal artic aneurysms in the United States ( ): a significant survival benefit ver pen repair is independently assciated with increased institutinal vlume. J Vasc Surg 2009; 49(4): Ouriel K, Clair DG, Kent KC et al.(2010) Endvascular repair cmpared with surveillance fr patients with small abdminal artic aneurysms. J Vasc Surg 2010; 51(5): Pwell JT, Greenhalgh RM.(2003) Small Abdminal Artic Aneurysms. NEJM 2003; QualChice reserves the right t alter, amend, change r supplement medical plicies as needed. QualChice reviews and authrizes services and substances. CPT and HCPCS cdes are listed as a cnvenience and any Page 7 f 9

8 348: Talent Abdminal Stent Graft System. Summary f Safety & Effectiveness Data. accessed 4/25/08. Ten Bsch JA, Teijink JA, Willigendael EM et al.(2010) Endvascular aneurysm repair is superir t pen surgery fr ruptured abdminal artic aneurysms in EVAR-suitable patients. J Vasc Surg 2010; 52(1):13-8. Teufelsbauer H, Prusa AM, Wlff K et al.(2002) Endvascular stent grafting versus pen surgical peratin in patients with infrarenal artic aneurysms: a prpensity screadjusted analysis. Circulatin 2002; 106: Teufelsbauer H, Prusa AM, Wlff K, et al.(2002) Endvascular stent grafting versus pen surgical peratin in patients with infrarenal artic aneurysms: a prpensity screadjusted analysis. Circ 2002; 106(7): The EVAR trial participants.(2004) Cmparisn f endvascular aneurysm repair with pen repair in patients with abdminal artic aneurysm (EVAR trial 1), 30-day perative mrtality results: randmised cntrlled trial. Lancet 2004; 364: The United Kingdm EVAR Trial Investigatrs.(2010) Endvascular repair f artic aneurysm in patients physically ineligible fr pen repair. N Engl J Med 2010; 362: The United Kingdm EVAR Trial Investigatrs.(2010) Endvascular versus pen repair f abdminal artic aneurysm. N Engl J Med 2010; 362: Thmas SM, Beard JD, et al.(2005) Results frm the prspective registry f endvascular treatment f abdminal artic aneurysms (RETA): mid term results t five years. Eur J Vasc Endvasc Surg 2005; 29: Treiman GS, Lawrence PF, Edwards WH Jr, et al.(1999) An Assessment f the Current applicability f the EVT endvascular graft fr Treatment f patients with an infrarenal abdminal artic aneurysm. J Vasc Surg 1999; 30: United Kingdm EVAR Trial Investigatrs.(2010) Endvascular repair f artic aneurysm in patients physically ineligible fr pen repair. N Engl J Med 2010; 362(20): United Kingdm EVAR Trial Investigatrs.(2010) Endvascular versus pen repair f abdminal artic aneurysms. N Engl J Med 2010; 362(20): Walker TG, Kalva SP, Yeddula K et al.(2010) Clinical practice guidelines fr endvascular abdminal artic aneurysm repair. J Vasc Interv Radil 2010; 21(11): QualChice reserves the right t alter, amend, change r supplement medical plicies as needed. QualChice reviews and authrizes services and substances. CPT and HCPCS cdes are listed as a cnvenience and any Page 8 f 9

9 White RA, Dnayre CE, Walt I, et al.(1997) Mdular bifurcatin endprsthesis fr Treatment f abdminal artic aneurysms. Ann Surg 1997; 226: Zarins CK, Crabtree T, et al.(2005) Endvascular repair r surveillance f patients with small AAA. Eur J Vasc Endvasc Surg 2005; 29: Zarins CK, White RA, SchwartenD, et al.(1999) AneuRx stent graft versus pen surgical repair f abdminal artic aneurysms: multicenter prspective clinical trial. J Vasc Surg 1999; 29: Applicatin t Prducts This plicy applies t ARBenefits. Cnsult ARBenefits Summary Plan Descriptin (SPD) fr additinal infrmatin. Last mdified by: Date: QualChice reserves the right t alter, amend, change r supplement medical plicies as needed. QualChice reviews and authrizes services and substances. CPT and HCPCS cdes are listed as a cnvenience and any Page 9 f 9