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ª 2 0 1 3 B Y T H E A M E R I C A N C O L L E G E O F C A R D I O L O G Y F O U N D A T I O N I S S N 1 9 3 6 - 8 7 9 8 / $ 3 6 . 0 0

P U B L I S H E D B Y E L S E V I E R I N C . h t t p : / / d x . d o i . o r g / 1 0 . 1 0 1 6 / j . j c i n . 2 0 1 3 . 0 5 . 0 0 4

STATE-OF-THE-ART PAPER

Management of Vascular Access inTranscatheter Aortic Valve Replacement

Part 2: Vascular Complications

Stefan Toggweiler, MD,*y Jonathon Leipsic, MD,* Ronald K. Binder, MD,*

Melanie Freeman, MBBS,* Marco Barbanti, MD,* Robin H. Heijmen, MD, PHD,zDavid A. Wood, MD,* John G. Webb, MD*

Vancouver, British Columbia, Canada; Lucerne, Switzerland; and Nieuwegein, the Netherlands

The interventional cardiologist must be able to recognize and manage potential vascularcomplications. Iliofemoral complications are the most frequent vascular complications in transfemoraltranscatheter aortic valve implantation. Small vessel dimensions, moderate or severe calcification, andcenter experience are the major predictors. The traditional treatment for injured arteries has beensurgical reconstruction, but endovascular techniques may allow for less invasive but effectivemanagement of arterial injuries. Dissection may be treated with prolonged balloon inflation ordeployment of a self-expanding or balloon-expandable stent or a surgical graft. Iliofemoral rupture isa serious complication that may lead to retroperitoneal bleeding that can be unrecognized. Rapidinsertion of a dilator or sheath or an occlusive balloon is used to achieve hemostasis. Prolongedballoon inflation or implantation of a covered stent or surgical repair should then be considered.Treatment options for failed percutaneous closure include prolonged manual compression, balloonangioplasty, stent implantation, and surgery. Aortic complications are rare, but serious complicationsare associated with a high mortality rate, even if emergent surgery is performed. There are specificvascular complications associated with alternative access routes such as transapical and transaxillaryand direct aortic access. (J Am Coll Cardiol Intv 2013;6:767–76) ª 2013 by the American College ofCardiology Foundation

Vascular complications are a major cause ofmorbidity and mortality in transcatheter aorticvalve implantation (TAVI) due to the large-bore catheters required. In this paper, we reviewthe frequency and causes of and treatmentoptions for different vascular complications.

Definitions of Vascular Complications

Most studies have used nonstandardized defi-nitions and thus have yielded a wide range ofvascular complication rates. Also, vascularcomplications are associated with bleeding,

From the *St. Paul’s Hospital, University of British Columbia, Vancou

Lucerne, Switzerland; and the zSt. Antonius Hospital, Nieuwegein, th

by a grant from the Swiss National Foundation. Drs. Binder, Leipsic, W

Dr. Heijmen is a consultant for and has received speaker honoraria from

no relationships relevant to the contents of this paper to disclose.

Manuscript received December 31, 2012; revised manuscript received A

which also has had nonstandardized definitions(1,2). In an attempt to allow direct comparisonamong clinical trials, the Valve AcademicResearch Consortium (VARC) has proposedstandardized definitions for clinical endpoints(3,4). These definitions were recently updated(VARC-2) (5,6). The definitions include allcomplications that can be caused by a wire,a catheter, or anything else related to vascularaccess (including left ventricular perforationand pseudoaneurysm). According to theVARC, only major vascular complications areconsidered important clinical endpoints.

ver, British Columbia, Canada; yLuzerner Kantonsspital,e Netherlands. Drs. Toggweiler and Binder are supported

ebb, and Wood are consultants to Edwards Lifesciences.

Medtronic. All other authors have reported that they have

pril 18, 2013, accepted May 9, 2013.

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Clinical Relevance of Vascular Complications

Frequency. The frequency of vascular complications intransfemoral TAVI is summarized in Table 1. Reported ratesof (major) vascular complications range from 1.9% to 17.3%(7–20).Impact on mortality. Vascular complications have beenassociated with morbidity, reduced quality of life, andincreased costs. Several studies have shown that mortality ishigher in patients with vascular complications than in thosewithout (odds ratios ranging from 2.4 to 8.5) (9,20–23).Impact on length of hospital stay. Hospital stay was signif-icantly longer in patients with major complications (16 days)than in those with minor (11 days) or no vascular compli-cations (6 days) (24). Another study yielded similar findingswith hospital stays of 17 and 10 days in patients with andwithout major vascular complications, respectively (20).

Vascular Complications of the Iliofemoral Arteries

Iliofemoral complications are the most common vascularcomplications in transfemoral TAVI. Studies have identifiedsmall vessel dimensions (minimal artery diameter smaller

Abbreviationsand Acronyms

TAVI = transcatheter aortic

valve implantation

VARC = Valve Academic

Research Consortium

than the external sheath diameteror sheath-to-femoral artery ratio>1.05), moderate or severe iliofe-moral calcification, and centerexperience as major predictors ofiliofemoral vascular complications(Table 2) (19,20,24). In our expe-rience, the combination of an ilio-

femoral artery diameter smaller than the external sheath sizeand the concomitant presence of moderate or severe calcifica-tion is associated with the highest vascular complication rate.In such patients, alternative access routes should be preferred.

Iliofemoral tortuosity was not found to predict vascularcomplications (20,24). Usually, the artery straightens out assoon as the stiff wire is advanced through the tortuous partof the artery (Fig. 1).

The traditional treatment for injured arteries has beensurgical reconstruction (25). Although the success rate forsurgical treatment is high, there are often considerablemorbidity and mortality (26). Surgical access, in combina-tion with hematoma and various comorbidities, oftenpredisposes to poor wound healing and infection in theseoften elderly and comorbid patients (27,28). Endovasculartechniques may allow for less invasive yet effectivemanagement of arterial injuries.Iliofemoral dissection. Dissection of the iliofemoral arteryrequiring percutaneous or surgical intervention has beenreported in 2.0% to 7.4% of patients undergoing trans-femoral TAVI with a surgical cutdown and in 1.6% to21.4% of patients undergoing percutaneous closure(20,23,24,29–36).

Whether a dissection requires treatment depends onthe extent and hemodynamic relevance. Usually, prolongedinflation of a balloon with appropriate diameter results insuccessful apposition of the intima and underlying media.However, more extensive dissection may warrant self-expanding or balloon-expandable stent deployment or asurgical graft (23,28,29,31–34,36).

Several cases of stent thrombosis have been reported aftertreatment of dissections with stents. Therefore, temporarytreatment with heparin (in addition to aspirin and clopi-dogrel) should be considered in such patients. The mortalityof iliofemoral dissection is low.Iliofemoral rupture. Rupture can occur if the delivery sheathis inserted in a small, calcified artery. Rupture of the ilio-femoral artery has been reported in both patients undergoingtransfemoral TAVI with a surgical cutdown (4.0% to 9.3%)and in patients undergoing percutaneous closure (0.7% to7.1%) (20,23,24,29–38). Most of the patients reported inliterature were treated with surgery, some with a coveredstent. Although a detailed outcome was not reported in all,at least 6 of 30 (20%) with ruptured iliac and/or femoralarteries died. Retroperitoneal bleeding after rupture can beunrecognized, and, therefore, in cases with borderline ilio-femoral anatomy, angiography should be performed fromthe ipsi- or contralateral side during or after retrieval of thelarge sheath.

When rupture or bleeding is detected, options includerapid insertion of a dilator or sheath or, alternatively, anocclusive balloon can be inserted (from the ipsilateral orcontralateral femoral) to achieve hemostasis. In case of asmaller perforation, crossover balloon inflation for up to 5 to10 min may be enough to stop the bleeding (Fig. 2). If thereis ongoing bleeding, implantation of a covered stent (Fig. 3)or surgical repair should be considered. If major vascularinjury occurs, endovascular occlusion with an occlusionballoon (e.g., Reliant Stent Graft Balloon Catheter, Med-tronic, Minneapolis, Minnesota; Berenstein OcclusionBalloon Catheter, Boston Scientific, Natick, Massachusetts;or Coda Occlusion Balloon Catheter, Cook Medical Inc.,Bloomington, Indiana) may be life saving (Figs. 4 and 5).These balloons are highly compliant and elongate withoutundue radial force once they reach the vessel diameter. Thedegree of inflation is monitored by fluoroscopy. After acutecontrol of the hemorrhage is achieved, definitive therapywith surgical repair or implantation of a covered stent isperformed (39).Access site infection. The risk of access site infection aftersuture-mediated closure has previously been described (40).In TAVI, access site infections were reported in 1.6% to6.3% of transfemoral cases (11,15,20,30,36,38,41). In thePARTNER 1A (Placement of Aortic Transcatheter Valves)study, 7 of 348 of the patients (2.0%) had a skin infection atthe puncture site. This rate was similar to the 2.0% ofpatients presenting with a sternal wound infection after

Table 1. Vascular Access and Complication Rate in Larger Series (�100 Patients) of Predominantly Transfemoral Transcatheter Aortic Valve Implantation

First Author (Year) N Sheath Size, F TechniqueVascular Complication

Rate, %*VARC

Definition

Piazza et al. (2008) 646 18–21 Percutaneous, ProStary 1.9 No

Bleiziffer et al. (2009) 137 18–24 Mostly percutaneous, ProStary 11.7 No

Webb et al. (2009) 113 22–24 Mostly surgical cutdown 8.0 No

Leon et al. (2010) 179 22–24 Surgical cutdown 16.2 Yes

Tamburino et al. (2011) 679 18–24 Mostly percutaneous, ProStary 2.0 No

Smith et al. (2011) 348 22–24 Surgical cutdown 11.0 Yes

Gurvitch et al. (2011) 310 18–24 Mostly percutaneous, ProGlidey 11.7 Yes

Lange et al. (2011) 412 18–24 Mostly percutaneous, ProStary 10.2 No

Hayashida et al. (2011) 130 18–24 Mostly percutaneous, ProStary 17.3 Yes

Stähli et al. (2011) 130 18–24 Mostly percutaneous 11.5 Yes

Nuis et al. (2011) 165 18 Mostly percutaneous 15.0 Yes

Moat et al. (2011) 599 22–24 Not reported 8.4 No

Toggweiler et al. (2012) 137 18–24 Percutaneous, ProGlidey 5.6 Yes

Gilard et al. (2012) 2361 18–24 Not reported 5.5 Yes

*Major vascular complication rate reported in series that used VARC definitions. yProStar and ProGlide closure systems, Abbott Vascular, Abbott Park, Illinois.

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surgical aortic valve replacement (11). Skin infections appearto be more common in patients undergoing a cutdown toexpose the femoral artery. Of 19 patients with infectionreported in the literature, 16 occurred in patients undergoinga planned surgical cutdown, and only 3 in patients under-going percutaneous closure. In general, superficial woundinfections should respond to local and/or systemic therapy.However, a deep periarterial infection may result in signif-icant morbidity. Death occurred in 2 of 19 patients (10.5%),due to sepsis in 1 patient (20,41).Stenosis/thrombosis/occlusion. Percutaneous closure witheither ProGlide Suture-Mediated Closure System or ProS-tar XL Percutaneous Vascular Surgical System (AbbottVascular, Abbott Park, Illinois) is usually associated withmild stenosis of the common femoral artery that is clinicallyasymptomatic (24). Post-dilation of the closure site can beperformed in case of a more severe stenosis (32,35). Stentingshould rarely be necessary.

Thrombosis can occur after hemostasis, for example, aftercrossover balloon-inflation. These patients can be treatedwith surgical revascularization or balloon angioplasty (32),but there is a risk of distal thromboembolization resulting inreduced perfusion of the limb (33).Artery avulsion. Adhesion of the sheath to the iliofemoralartery is an unusual complication (32,42). In patients withborderline iliofemoral arteries, the sheath can adhere directly

Table 2. Predictors of Vascular Complications

First Author (Year) N

Lange et al. (2011) 412 Center experience, plan

Hayashida et al. (2011) 130 Sheath-to-femoral arter

Toggweiler et al. (2012) 137 Sheath diameter greate

Généreux et al. (2011) 419 Female sex

to the endothelium. The operator feels resistance duringsheath withdrawal and sudden hemorrhage may occur. Therisk of avulsion is reduced with smaller sheaths, periodicsheath rotation (not advisable with the expandable sheath),and early sheath removal (42). If avulsion is suspected, anocclusion balloon should be placed, and the patient shouldbe prepared for possible surgical repair.Pseudoaneurysms. Pseudoaneurysm formation can occurwhen the arterial puncture site seals incompletely, resultingin contained bleeding into the soft tissue within a pseudo-capsule (43). The diagnosis should be suspected in a patientwith a painful, pulsatile groin mass. A murmur may be heardon auscultation. Risk factors for pseudoaneurysms areincreasing sheath size, advanced age, cannulation of anartery other than the common femoral artery, calcification,increased body mass index, female sex, current anticoa-gulation, combined arterial and venous puncture, and failureto provide appropriate compression (44). Several studieshave reported spontaneous closure of pseudoaneurysms in>50% of cases. Therefore, it appears reasonable to observea pseudoaneurysm if the size is <3.0 to 3.5 cm, there is noassociated pain, and no need for oral anticoagulation (45–47).Treatment options are ultrasound-guided compression andultrasound-guided thrombin injection. In studies investi-gating both, success rates for ultrasound-guided thrombininjection were consistently higher (93% to 100%) than after

Predictors

ned surgical cutdown reduced vascular complication rate

y ratio, femoral calcification, center experience

r than minimal artery diameter, moderate/severe femoral calcification, learning curve

Figure 1. Transcatheter Aortic Valve Implantation in Patients With Iliofemoral Tortuosity

A patient with tortuosity of his external iliac artery (A, arrow) that straightened out after it was crossedwith thewire and the sheath. However, the sheath kinked (B, arrow),but the procedure was successfully carried out after the sheath was replaced. Contralateral angiography showed minimal stenosis after closure with ProGlide system(Abbott Vascular, Abbott Park, Illinois) (C). Extensive tortuosity of the external iliac artery (D) that straightened out with an Amplatz Extra Stiff Wire (Cook Medical Inc.,Bloomington, Indiana) and an 18-F Edwards sheath (Edwards Lifesciences, Irvine, California) (E). Crossover angiography confirmed a good result after closure (F).

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ultrasound-guided compression (0 to 87%) (40,48–54).Ultrasound-guided thrombin injection is considered to bevery safe, with complications such as infection, thrombosis,and distal embolization occurring in <1% of cases (44).Patients in whomminimally invasive techniques failed shouldundergo surgical repair.Failed percutaneous closure. Failed closure with a ProStaror Perclose ProGlide (Abbott Vascular) requiring interven-tion or surgery or leading to relevant bleeding has beendescribed in 4.4% to 8.7% of cases (18- to 24-F sheaths)(20,32,35–37). Of 30 cases of failed percutaneous closurereported in the literature, 7 (23%) were treated with surgery,4 (13%) with prolonged manual compression only, 5 (17%)with stent implantation, 3 (10%) with balloon angioplasty,and 1 (3%) with aortic balloon occlusion and manualcompression.

Access site bleeding. In patients undergoing percutaneouscoronary intervention, bleeding has been shown to beassociated with prolonged hospital stay, increased need forblood transfusion, and mortality (55–57). Furthermore,blood transfusion has been directly linked with excessmortality (58). The possible mechanisms include pro-thrombotic effects, impaired oxygen delivery of transfusederythrocytes, microvascular obstruction, and transfusionrelated immunomodulation (59). In transfemoral TAVI,access site bleeding was reported in 2.2% to 12.5%(20,24,29,37,38,41). A large hematoma can form veryquickly despite manual compression and warrants immediateaction. A catheter should be advanced from the contralateralside to achieve control of the artery. A smaller injury ofthe femoral artery can usually be managed with balloonocclusion. If a larger injury occurs, a stent-graft should be

Figure 2. Treatment of Femoral Artery Injury With a Balloon Catheter

This patient presented with stenosis and ongoing bleeding of the common femoral artery after closure with the ProGlide system (Abbott Vascular, Abbott Park, Illinois)(A). An 8 � 40-mm balloon was inflated (B), resulting in hemostasis and moderate, asymptomatic residual stenosis (C). This complication was managed withoutprotamine reversal.

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implanted (60). Self-expanding nitinol stents are preferredover balloon-expandable stents because they are moreresistant to external compression and bending stress (61).

Aortic Complications

Aortic complications such as aortic dissection and perforationhave been reported in 0 to 1.9% of patients undergoingtransfemoral TAVI (17,20,22,23,30,34,35,62). These seriouscomplications are associated with a very high mortality rate.Aortic aneurysms. Aneurysms of the iliac arteries or theabdominal aorta are frequently present in patients under-going TAVI (Fig. 6). Usually, these aneurysms can be

Figure 3. Treatment of Femoral Artery Injury With a Covered Stent

(A) This patient presented with acute hemorrhage of the femoral artery. Bleeding wasself-expanding stent-graft (Bard Canada Inc., Oakville, Ontario, Canada) was implante

passed with the delivery sheath without any problems. Adelayed lethal rupture of the descending aorta has beenreported in a patient with a previously stent-treated abdo-minal aneurysm 4 h after transfemoral TAVI (19). Ina minority of patients, iliofemoral access is suitable fortransfemoral TAVI, but there is relevant kinking of theaorta. More than slight kinking of the thoracic or abdominalaorta may lead to difficulties when trying to position thevalve for implantation (19). In this case, an alternative accessroute should be preferred.Aortic rupture. Acute or delayed aortic annular rupture isa rare but serious complication with a very poor prognosis,even if emergent surgery is performed (31,33,63,64).

controlled with balloon tamponade and then, a Fluency Plus 9� 60-mm coveredd with a good result (B,C).

Figure 4. Examples of Occlusion Balloon Catheters

Berenstein occlusion balloon catheter (Boston Scientific, Natick, Massachusetts) (A) and Coda Occlusion Balloon Catheter (Cook Medical Inc., Bloomington, Indiana) (B).(C) Inflated occlusion balloon in the left femoral artery. Note that the balloon assumes the shape of the artery and expands longitudinally once the vessel walls arereached.

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Rupture of the descending aorta or the annulus has beenreported in 0 to 2.0% of patients undergoing TAVI(11,19,20,24,30,31,33,35). Annular rupture may occur afterballoon valvuloplasty or after valve implantation (morefrequently with balloon-expandable valves) and lead to acute

Figure 5. Occlusion of the Aorta to Treat a Femoral Bleeding

This patient had a perforated right common femoral artery (A, arrow). An occlusion bwas implanted to treat the perforation (C, arrow).

rupture, cardiac tamponade, or death. Two cases of delayedaortic annulus rupture 24 h and 27 h after implantation ofthe Medtronic CoreValve (Medtronic, Minneapolis, Min-nesota) have been described (19). Meticulous measurementof the annulus with multi-slice computed tomography or

alloon was inflated in the lower abdominal aorta (B, arrow), and a covered stent

Figure 6. Transcatheter Aortic Valve Implantation in Patients With Iliofemoral or Aortic Aneurysms

Patients with iliac (A,B), abdominal (C,D), or both iliac and abdominal (E,F) aneurysms are not infrequent. Careful passage of a guidewire followed by over-the-wirepassage of catheters can generally be accomplished with low risk.

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biplane transesophageal echocardiography may reduce therisk of extreme oversizing (65–67). The risk of perforationmay be higher in patients with a very calcified valve. On theother hand, an undersized valve may lead to moderate/severeparavalvular regurgitation or embolization of the valve (66).Aortic dissection. Aortic dissection has been reported in 0 to1.9% of transfemoral TAVI cases (11,20,22,24,35,62).Traditionally, the treatment for most patients with injury ofthe descending aorta has been surgical intervention withgraft interposition (68). More recently, endoluminal stent-graft procedures have become increasingly popular and areassociated with lower mortality and paraplegia rates thanopen repair (68).Retroperitoneal hemorrhage. A retroperitoneal bleed can becaused by injury of the aorta, the iliac or proximal commonfemoral artery, or a small branch vessel such as the inferiorepigastric artery. Bleeding may occur after incomplete closureif the sheath is removed from the proximal common femoralartery or the external iliac artery. The diagnosis is oftendelayed as symptoms are nonspecific (hemodynamic insta-bility, groin/flank/abdominal/back pain) (69). When a retro-peritoneal hematoma is suspected, computed tomography orangiography should be performed to confirm the diagnosis.

After TAVI, retroperitoneal hemorrhage has been re-ported in 0 to 2.2% of cases (17,24,30,33,36,37,41). TAVIpatients who often present with poor cardiac reserve andsevere comorbidities may be at increased risk of mortality inthe context of bleeding.

Most of the retroperitoneal hematomas do not requireintervention and can be managed with administration offluids, normalization of coagulation factors, and bloodtransfusion (69). If the patient becomes unstable or thehemoglobin does not respond to blood transfusion, angiog-raphy may be able to identify the source of bleeding.Temporary balloon occlusion may be enough to achievehemostasis in cases of smaller injuries. A larger injury of theiliac artery can be treated with a covered stent. Rupture ofa small branch such as the inferior epigastric artery may betreated with a coil embolization, balloon tamponade, acovered stent, or surgery. A high groin exposure or retroper-itoneal incision is usually performed with direct suture repairof the injury (37,41,43).

Vascular Complications Associated WithAlternative Access Routes

Vascular complications associated with transapical access.The most frequent acute complications are bleeding fromthe apical puncture site and myocardial tears requiringfurther surgical repair (70,71). Apical scarring resulting froma hematoma or myocardial sutures may result in localhypokinesis. This may be a problem in patients with a lowpre-procedural ejection fraction but preserved apicalcontraction (72). A puncture close to the left anterior

descending coronary artery may lead to tension resulting inflow obstruction (73). Long-term complications includeaneurysm formation, chronic pain caused by rib retraction,pleural dissection, and intercostal nerve damage(15,22,31,38,74–76).Vascular complications associated with transaxillary access.Manipulation of a large sheath inside the axillary andsubclavian artery can cause vascular injury. Thrombosis ofthe subclavian artery has been reported after transaxillaryTAVI (33). Lange et al. (19) reported the outcomes of28 patients; 1 patient had a subclavian artery injury duringCoreValve implantation, and the vessel was repaired byinterposition of a vascular prosthesis. One patient hada asymptomatic subclavian artery dissection after CoreValveimplantation. Dissection of the left subclavian artery may bea problem in patients with a patent left internal mammaryartery graft (77).Vascular complications associated with transaortic access. Inelderly and frail patients, the aortic wall may be fragile, andtearing of the aorta may occur when tightening the sutures.Other specific complications of the direct aortic accessinclude deep wound infection or mediastinitis after partialsternotomy. A right mini-thoracotomy may lead to injury ofa right internal mammary graft. Rare complications withtransaortic access include laceration of the right ventricleafter right mini-thoracotomy and pseudoaneurysm forma-tion of an intercostal artery after mini-sternotomy(72,73,78–82).

Summary

Although vascular complications will continue to occur, webelieve that with lower profile sheaths, better screeningtechniques, appropriate choice of access site, and operatorexperience, lower complication rates will be achieved in futureclinical trials and clinical routine. Nevertheless, the inter-ventional cardiologist must be able to recognize and managepotential vascular complications. With increased experience,most of the vascular complications associated with thetransfemoral approach may be managed percutaneously.

We believe that specific access site complication ratesshould be reported rather than overall minor and majorvascular complications so that readers may know whichissues have improved and which remain a problem as TAVItechnology advances.

Reprint requests and correspondence: Dr. John G Webb, St.Paul’s Hospital, 1081 Burrard Street, Vancouver, British ColumbiaV6Z 1Y6, Canada. E-mail: john.webb@vch.ca.

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KeyWords: aortic stenosis - complications - transcatheteraortic valve implantation - transcatheter aortic valvereplacement.