Ann Vasc Dis Vol. 6, No. 2; 2013; pp Online April 20, Annals of Vascular Diseases doi: /avd.oa Original Article

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1 Ann Vsc Dis Vol. 6, No. 2; 2013; pp Online April 20, Annls of Vsculr Diseses doi: /vd.o Originl Article Protocol-Bsed Strtegy for Endovsculr Repir of Ruptured Abdominl Aortic Aneurysms Hidemitsu Ogino, MD, Kzuno Wtnbe, MD, Yuki Ikegy, MD, Jun Kwchi, MD, Ri Shimoym, MD, nd Noko Isogi, MD Objective: Compred with conventionl open surgery (COS), endovsculr neurysm repir (EVAR) hs been reported to decrese the 30-dy mortlity rte in ptients with ruptured bdominl ortic neurysms (raaas). We developed n EVAR-first strtegy for raaas tht incorportes the Shonn ruptured bdominl ortic neurysm protocol (SRAP). We describe short-term results with this protocol t our institution nd compre them with outcomes in ptients who underwent COS. Methods: The records of ll 57 ptients in whom raaa ws repired during 7-yer period were reviewed retrospectively. Ptients in the COS group (n = 30) were treted between Jnury 2005 nd December 2009; those in the SRAP group (n = 27) were treted between Jnury 2010 nd Mrch The two groups were compred with respect to ptient chrcteristics t dmission, including severity of condition; opertive nd in-hospitl vribles; nd 30-dy mortlity. Results: The bseline ptient chrcteristics in the COS nd SRAP groups were similr except tht the SRAP group hd significntly higher rte of cerebrovsculr disese. The 30-dy mortlity rte ws significntly higher in the COS group (43% vs. 19%), s were the intropertive mortlity rte (27% vs. 5%) nd the in-hospitl mortlity rte (57% vs. 26%; P <0.05 for ll comprisons). The technicl success rte for EVAR ws 96%; no conversions to open surgery were required. Conclusions: Use of the SRAP is promising strtegy for improving initil outcomes in ptients with raaas. Keywords: bdominl ortic neurysm, rupture, EVAR Introduction Endoluminl therpy for bdominl ortic neurysms (AAAs) ws first reported by Prodi, et l. 1) in Subsequently, lrge trils found tht erly endovsculr neurysm repir (EVAR) provided better outcomes thn lprotomy, 2,3) nd EVAR becme the Division of Vsculr Surgery, Deprtment of Surgery, Shonn Kmkur Generl Hospitl, Kngw, Jpn Received: October 1, 2012; Accepted: Februry 9, 2013 Corresponding uthor: Hidemitsu Ogino, MD. Division of Vsculr Surgery, Deprtment of Surgery, Shonn Kmkur Generl Hospitl, Okmoto, Kmkur, Kngw , Jpn Tel: , Fx: E-mil: hogino@shonnkmkur.or.jp stndrd tretment for AAAs. Outcomes with ruptured AAAs (raaas), however, remin unstisfctory becuse ptients re usully treted on n emergency bsis nd their overll condition is poor, with mny being in shock nd hving hemodynmic instbility nd disturbed consciousness. A 2002 met-nlysis found tht the shortterm mortlity rte mong ptients with raaas ws 48% nd tht the survivl rte hd not improved in 20 yers. 4) The use of EVAR for raaa repir ws first reported by Mrin, et l. 5) in In 2000, Ohki, et l. 6) described series of 20 ptients with raaas who underwent EVAR nd hd 30-dy mortlity rte of 10%. A 2008 systemtic review nd met-nlysis by Mstrcci, et l. 7) found tht EVAR for raaas ws ssocited with 21% mortlity rte. Their investigtion lso indicted the importnce of Annls of Vsculr Diseses Vol. 6, No. 2 (2013) 169 AVD-OA Ogino_R.indd /06/11 11:07:34

2 Ogino H, et l. protocol-bsed pproch to improving raaa tretment outcomes. About 15 emergency opertions for n raaa re performed t our institution ech yer. Approximtely hlf the ptients treted hve been trnsferred from nother hospitl. Until December 2009, ll raaa repirs involved lprotomy, performed ccording to stndrd conventionl open surgery (COS) protocol. Thus, when emergency room (ER) physicins suspected n raaa fter n echogrphic or computed tomogrphic (CT) evlution, they clled surgeon. After ll the surgicl instruments nd nesthetic gents nd equipment hd been prepred, the ptient ws trnsferred to the operting room (OR), where ortic clmping below the renl rtery or bove the celic rtery ws done, nd stright grft (I-grft) ws replced. If the ER personnel determined tht ptient ws in shock, thorcotomy in the left side of the chest ws ccomplished immeditely, the descending ort ws clmped, nd the ptient ws then trnsferred to the OR for raaa repir. In 2010, we developed new protocol for treting ptients with raaas: the Shonn ruptured bdominl ortic neurysm protocol (SRAP; Fig. 1). The protocol, which is bsed on n EVAR-first pproch nd n lgorithm described by Meht, et l., 8) clerly specifies the roles nd responsibilities of the ER stff, on-cll surgeon, nesthesiologists, OR stff, nd rdiology stff (Tble 1). It lso provides detiled instructions for ll procedures, including ptient trnsfers. Becuse the primry gol of development of the SRAP ws to use EVAR s the initil tretment for raaas in s mny cses s possible, our morphologic indictions for EVAR were less strict thn those in the mnufcturer s instructions for use (IFU) for the endoprosthesis employed. A secondry im of cretion of the SRAP ws to prioritize ptients trnsfer to the OR nd thereby expedite the progression from dignosis to insertion of n ortic occlusion blloon (AOB). We describe retrospective comprison between short-term ptient outcomes chieved with the SRAP nd those obtined with COS. Methods All ptients or their representtives provided informed consent to use of the SRAP, which ws pproved by both n in-house nd n externl institutionl review bord. Under the SRAP, when ER physicins suspected raaa fter n initil echogrphic evlution, Fig. 1 Shonn ruptured bdominl ortic neurysm (raaa) protocol (SRAP). The rupture set consists of 12F sheths (Ultimum Introducer; St Jude Medicl, St Pul, Minnesot, USA); inch, 200-cm guide wire (Rdifocus; Terumo Europe, Leuven, Belgium); inch, 180-cm Super stiff guide wire (Boston Scientific, Ntick, Msschusetts, USA); 60-cm KMP ctheter (COOK MEDI- CAL, Bloomington, Indin, USA); 110-cm pigtil ctheter (COOK); nd n ortic occlusion blloon (AOB) (Relint; Medtronic Vsculr, Snt Ros, Cliforni, USA). CTA: computed tomogrphic ngiogrphy; OR: opertion room; EVAR: endovsculr neurysm repir hemodynmiclly stble ptients undergo CT ngiogrphy (CTA) in the ER, wheres hemodynmiclly unstble ptients re tken to the OR immeditely. In ll ptients, percutneous insertion of 12F sheth (Ultimum Introducer; St Jude Medicl, St Pul, Minnesot, USA) into the femorl rtery is performed, followed by insertion of n AOB (Relint; Medtronic Vsculr, Snt Ros, Cliforni, USA). If the ptient is hemodynmiclly unstble, the blloon is inflted, nd the ort is occluded. If CTA confirms tht the morphologic fetures of the neurysm re suitble for EVAR, the ptient is considered eligible for this procedure. Under the SRAP, suitble morphologic fetures re n neurysm neck dimeter of between 18 nd 30 mm, neck ngultion of less thn 90 degrees, nd neck longer thn 5 mm. An Excluder AAA Endoprosthesis (WL Gore & Assocites, Flgstff, Arizon, USA) is used in ll endovsculr raaa repirs. In hemodynmiclly unstble ptients in whom contrlterl cnnultion would be difficult to chieve, n ortic extender is used to occlude the contrlterl leg (ortouni-ilic [AUI] technique nd femorofemorl [FF] bypss). 170 Annls of Vsculr Diseses Vol. 6, No. 2 (2013) AVD-OA Ogino_R.indd /06/11 11:07:34

3 Tble 1 Protocol-Bsed Strtegy for Endovsculr Repir of Ruptured Abdominl Aortic Aneurysms Roles nd clinicl ctivities of stff members under the Shonn protocol for tretment of ruptured bdominl ortic neurysms Stff Role Clinicl ctivities ER stff Initil cre Alert on-cll surgeon Prepre ptient for trnsporttion Strt venous line Initite permissive hypotension Perform CTA Order trnsfusion components (10 units ech of PRBCs, FFP, nd PCs) On-cll surgeon OR stff Cll vsculr tem Ensure quick, semless ptient trnsporttion Prepre for rpid dmission of ptient to the OR Cll nesthesiologist, OR stff, rdiology technicin Register ptient Obtin informed consent Prepre rupture set nd open-repir set Rdiology technicin Prepre fluoroscope Turn on rdiology equipment Set up power injector If the ptient is hemodynmiclly stble. ER: emergency room; CTA: computed tomogrphic ngioplsty; PRBCs: pcked red blood cells; FFP: fresh frozen plsm; PCs: pltelet cells; OR: operting room Tble 2 Chrcteristics of ptients in the two tretment groups Chrcteristic COS group b (n = 30) SRAP group b (n = 27) Men ± SD ge, yers 78.2 ± ± 10.2 Sex: Mle/femle 26 (87)/4 (13) 22 (81)/5 (19) Renl insufficiency 10 (33) 4 (15) Dibetes mellitus 3 (10) 5 (19) Hypertension 18 (60) 15 (56) Angin pectoris 6 (20) 4 (15) Previous myocrdil infrction 3 (10) 5 (19) Cerebrovsculr disese 0 (0) 4 (15) Chronic obstructive pulmonry disese 1 (3) 1 (4) Shock 15 (50) 11 (41) Assessments of condition severity Men Glsgow neurysm score Men Fitzgerld clssifiction (scle, 1 4) Men Hrdmn index vlue (scle, 1 5) Dt re shown s the number (%) or s indicted, b There were no significnt differences between groups except for the presence of cerebrovsculr disese (P <0.05). COS: conventionl open surgery; SRAP: Shonn ruptured bdominl ortic neurysm protocol If the morphologic fetures of the neurysm re unsuitble for EVAR, the ptient undergoes COS under generl nesthesi. During the opertion, the ort is replced while the bleeding is controlled with n AOB. All ptients who hve n raaa repir, regrdless of whether n endovsculr or open pproch is used, re trnsferred to the intensive cre unit fter their procedure. In this study, ptients who underwent EVAR under the SRAP nd those who hd COS under the older protocol were compred with respect to bseline chrcteristics, operting time for raaa repir, units of blood trnsfused during the repir, intropertive mortlity rte, in-hospitl mortlity rte, durtion of hospitl sty, 30-dy mortlity rte (primry endpoint), nd cuse of postopertive deth. The severity of the preopertive condition of ll ptients ws ssessed by using the Glsgow neurysm score, 9) the Fitzgerld clssifiction, 10) nd the Hrdmn index. 11) A t-test, chi-squre test, or Fisher exct test ws used to compre vribles in the COS nd SRAP groups. A P vlue of less thn.05 ws considered to represent significnt difference. All sttisticl nlyses used Microsoft Excel 2008 for Mc, Version (Microsoft, Redmond, Wshington, USA). Results The study included the 57 ptients with raaas treted consecutively t our institution between Jnury 2005 nd Mrch Thirty of these ptients underwent COS between Jnury 2005 nd December The other 27 hd procedure (24 EVAR nd 3 open repirs) under Annls of Vsculr Diseses Vol. 6, No. 2 (2013) 171 AVD-OA Ogino_R.indd /06/11 11:07:35

4 Ogino H, et l. Tble 3 Opertive nd periopertive results in the two tretment groups Vrible COS group (n = 30) SRAP group (n = 27) P Operting time, minutes 152 ± ± Blood trnsfused, units 37.4 ± ± Intropertive mortlity 8 (26.6) 2 (5) <.05 In-hospitl mortlity 17 (56.6) 7 (25.9) <.05 Hospitl sty, dys 47.5 ± ± Dy mortlity 13 (43.3) 5 (18.5) < Dy mortlity due to MOF 5 (16.6) 3 (11.1) b.36 Continuous dt re shown s the men ± SD; ctegoric dt s number (%), b Two ptients hd bdominl comprtment syndrome. COS: conventionl open surgery; SRAP: Shonn ruptured bdominl ortic neurysm protocol; MOF: multiple-orgn filure Tble 4 Chrcteristic Chrcteristics of the 24 EVAR procedures performed under the SRAP No. (%) of cses Preopertive CTA 22 (91.6) Endovsculr device used outside IFU guidelines 12 (50) Technicl success 23 (95.8) b Conversion to open surgery 0 (0) Bsic procedure Bifurction 22 (91.6) AUI + FF bypss 2 (8.3) Additionl procedure Aortic cuff 8 (33.3) Chimney 1 (4.1) IIA coil emboliztion 1 (4.1) Leg extension 7 (29.1) All ptients hd hostile neurysm neck, b An ortic occlusion blloon ws used in one ptient. EVAR: endovsculr neurysm repir; SRAP: Shonn ruptured bdominl ortic neurysm protocol; CTA: computed tomogrphic ngiogrphy; IFU: instructions for use; AUI: orto-uni-ilic technique; FF: femorofemorl; IIA: internl ilic rtery the SRAP, between Jnury 2010 nd Mrch The three open repirs in the SRAP group were performed becuse the morphologic fetures of the neurysm neck did not meet the criteri for EVAR specified in the protocol. Tble 2 shows bseline chrcteristics of the ptients in the study. The only significnt difference between the COS nd EVAR groups ws the higher rte of cerebrovsculr disese in the SRAP group (P <0.05). The results of Glsgow neurysm scoring indicted tht ll 57 ptients were t high risk of deth fter open surgery for AAA. Tble 3 shows opertive nd periopertive dt for the two tretment groups. The 30-dy mortlity rte ws 43.3% in the COS group (13 of 30 ptients) nd 18.5% (5 of 27) in the SRAP group, with the difference being significnt (P <0.05). Moreover, compred with ptients in the COS group, those in the SRAP group hd significntly lower rtes of both intropertive nd in-hospitl mortlity. There were no significnt differences between groups in operting time, units of blood trnsfused, durtion of hospitl sty, or deths due to multiple-orgn filure (MOF). Chrcteristics of the 24 EVAR procedures done under the SRAP re shown in Tble 4. Technicl success ws chieved in ll but one ptient. The ptient in whom the endoprosthesis could not be plced ws 98-yer-old mn who ws in shock t rrivl t our hospitl. After ortic cross-clmping with n AOB, he hd crdic rrest nd died, despite crdiopulmonry resuscittion ttempts. In two ptients, the AUI technique nd FF bypss were required becuse of hemodynmic instbility. All 172 Annls of Vsculr Diseses Vol. 6, No. 2 (2013) AVD-OA Ogino_R.indd /06/11 11:07:35

5 Protocol-Bsed Strtegy for Endovsculr Repir of Ruptured Abdominl Aortic Aneurysms 12 ptients in whom the endoprosthesis ws used outside the IFU guidelines hd hostile neurysm neck, but the neck did meet the morphologic criteri stipulted in the SRAP. In two ptients, preopertive CT scnning ws not fesible becuse the ptients were hemodynmiclly unstble, but imges were obtined intropertively for both. Seventeen of 24 ptients who hd undergone EVAR hd n dditionl procedure. Discussion Our findings suggest tht the introduction of the SRAP resulted in n improvement in erly outcomes of procedure for treting raaas tht is less invsive thn COS. Fctors tht probbly contributed to the improvement were creful ptient selection ccording to morphologic criteri nd multidisciplinry pproch tht expedited the tretment process. Our study ws not designed to ssess whether results chieved with EVAR of raaas re superior to those with COS. A forml comprison between EVAR nd COS would require rndomized study, but we believe tht such study would not be ethiclly cceptble. However, nonrndomized prospective study might provide useful comprtive dt. With the use of the SRAP t our institution, EVAR could be ccomplished in ll but one cse meeting the bsic criteri for n endovsculr repir. The neurysm neck in n raaa is often hostile becuse of the lrge dimeter of the neurysm sc nd the steep neck ngle; therefore, implnttion of the endoprosthesis must be tilored to the specific morphologic fetures of the neck. We prefer to withdrw the floppy portion of the stiff wire tht reches the tip of the delivery system nd deploy the device while pressing on the delivery system. We think this method is the esiest to perform nd the most pproprite for hectic emergency sitution. Others hve suggested bending the stiff wire ) Furthermore, to fcilitte good fit between the rigid body of the endoprosthesis nd torturous neck, we implnt the device with the body in lower position nd dd n ortic extender. If lrge endolek nd hemodynmic instbility develop, however, conversion to open surgery becomes unvoidble. Conversion in this sitution is chllenging nd requires extensive surgicl experience. The reduction in intropertive mortlity we observed under the SRAP ws probbly due to minimiztion of blood loss chieved by prompt ortic-cross crmping with n AOB, which llowed ptients to recover from shock. We nticipted tht mintennce of blood perfu- sion to the orgns nd prevention of cogulopthy would reduce postopertive deths from MOF, but the COS nd SRAP groups hd similr MOF-relted mortlity rte. Our results, therefore, suggest tht the introduction of new techniques to mitigte the risk of MOF in ptients who hve undergone raaa repir will be key fctor in incresing survivl rte. Abdominl comprtment syndrome (ACS), lifethretening condition, hs been found to be ssocited with endovsculr repir of raaas. Meht, et l. 15) reported tht the development of ACS is relted to the hemodynmics of the specific neurysm nd tht ptients with ACS re more likely to hve n incresed ctivted prtil thromboplstin time nd require n AOB nd mssive trnsfusion. They lso observed tht the mortlity rte mong ptients in whom ACS occurs fter AAA repir is significntly higher thn tht in ptients who do not hve n onset of ACS (67% vs. 10%; P = 0.01). Meht, et l. recommended tht intrvesiculr pressure be monitored closely in ptients who hve undergone endovsculr raaa repir nd tht decompressive lprotomy be performed promptly when the pressure increses or worsening of ACS is observed. The SRAP does not currently specify postopertive mngement prctices, but dding such specifictions to future versions of the protocol my enhnce its effectiveness in improving raaa tretment outcomes. Conclusions With the introduction of the SRAP, n EVAR-first strtegy for repiring raaas, intropertive, in-hospitl, nd 30-dy mortlity rtes decresed in comprison with rtes ssocited with COS. Thus, the SRAP ppers to be useful when performed by EVAR experienced physicin in improving erly outcomes of raaa tretment. Midterm nd long-term results with the use of the SRAP remin to be determined. Acknowledgement The uthors thnk Renée J. Robillrd, MA, ELS, for editoril ssistnce. Disclosure Sttement Hidemitsu Ogino nd couthors hve no conflicts of interest. Annls of Vsculr Diseses Vol. 6, No. 2 (2013) 173 AVD-OA Ogino_R.indd /06/11 11:07:35

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