Dato I, Burzotta F, Trani C, Crea F, Ussia GP. Percutaneous management of vascular access in transfemoral transcatheter aortic valve implantation. World J Cardiol 2014; 6(8): 836-846 [PMID: 25228962 DOI: 10.4330/wjc.v6.i8.836]
Corresponding Author of This Article
Ilaria Dato, MD, Institute of Cardiology, Catholic University of the Sacred Heart, Largo Agostino Gemelli, 8, 00168 Rome, Italy. ilariadato81@gmail.com
Research Domain of This Article
Cardiac & Cardiovascular Systems
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Review
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Ilaria Dato, Francesco Burzotta, Carlo Trani, Filippo Crea, Institute of Cardiology, Catholic University of the Sacred Heart, 00168 Rome, Italy
Gian Paolo Ussia, Department of Cardiovascular Disease, Tor Vergata University, 00133 Rome, Italy
ORCID number: $[AuthorORCIDs]
Author contributions: Dato I, Burzotta F, Trani C, Crea F and Ussia GP contributed equally to this article.
Correspondence to: Ilaria Dato, MD, Institute of Cardiology, Catholic University of the Sacred Heart, Largo Agostino Gemelli, 8, 00168 Rome, Italy. ilariadato81@gmail.com
Telephone: +39-6-3051166 Fax: +39-6-3055535
Received: April 15, 2014 Revised: June 1, 2014 Accepted: June 18, 2014 Published online: August 26, 2014 Processing time: 155 Days and 14.4 Hours
Abstract
Transcatheter aortic valve implantation (TAVI) using stent-based bioprostheses has recently emerged as a promising alternative to surgical valve replacement in selected patients. The main route for TAVI is retrograde access from the femoral artery using large sheaths (16-24 F). Vascular access complications are a clinically relevant issue in TAVI procedures since they are reported to occur in up to one fourth of patients and are strongly associated with adverse outcomes. In the present paper, we review the different types of vascular access site complications associated with transfemoral TAVI. Moreover, we discuss the possible optimal management strategies with particular attention to the relevance of early diagnosis and prompt treatment using endovascular techniques.
Core tip: Vascular complications are not rare in transcatheter aortic valve implantation (TAVI) by the transfemoral approach and can significantly affect the overall clinical outcome. After diagnosis, the application of simple vascular interventional techniques allows efficient complication management, thus avoiding high risk vascular surgery. We discuss the available percutaneous vascular access preparation by dedicated devices, the principal diagnostic tools for prevention and detection of vascular complications and their percutaneous management in the transfemoral TAVI setting.
Citation: Dato I, Burzotta F, Trani C, Crea F, Ussia GP. Percutaneous management of vascular access in transfemoral transcatheter aortic valve implantation. World J Cardiol 2014; 6(8): 836-846
Transcatheter aortic valve implantation (TAVI) using stent-based bioprostheses has recently emerged as a promising alternative to surgical valve replacement in selected patients[1,2]. At present, for transfemoral TAVI the most studied valves are a balloon-expandable prosthesis, the Edwards SAPIEN XT™ valve (Edwards Lifesciences, Irvine, California, United States), that has recently added to the first generation Edwards valve, the Edwards SAPIEN (and in Europe has replaced it), and a self-expandable prosthesis, the CoreValve ReValving System® (Medtronic Inc., Minneapolis, MN, United States). Percutaneous implantation is generally performed using retrograde access from the femoral artery[3]. In spite of the increasing diffusion of TAVI across the world, with a high rate of procedural success and significant clinical and hemodynamic benefits[4,5], procedural challenges remain relevant. Among the different procedural technical issues, femoral access management is emerging as a factor with paramount clinical relevance. Indeed, major vascular complications during TAVI may range between 5% and 25% of patients[6], and are associated with a striking increase in early mortality risk[7-10].
PREDICTORS OF VASCULAR COMPLICATIONS AND SELECTION OF VASCULAR ACCESS
The rate of vascular access site complications is probably influenced by several factors, which include the size of the devices (with favorable impact expected from the reduction in sheath size required by the latest generation valves), patient anatomy and the operator’s experience/technique in deploying the closure devices[11]. Periprocedural bleeding after TAVI is frequent and principally related to renal function and sheath diameters, as reported in a recent Italian multicenter study[12]. Life-threatening and major bleeding, along with severe kidney failure, are independent predictors of increased mortality after 30 d[12].
While the first introduced bioprosthetic valve (Edwards SAPIEN) was characterized by a larger diameter (internal diameter 22-24 F and external diameter 8-9 mm) and required a minimal external arterial diameter of 7-8 mm, the Edwards SAPIEN XT™ valve and the Medtronic CoreValve System® valve which are characterized by an external diameter of about 7 mm (internal diameter 16-20 F and 18 F, respectively) necessitate a minimal external arterial diameter of about 6-7 mm (6 mm for 16 F e-Sheath and standard 18 F sheath, if ilio-femoral arteries are not severely calcified). Calcific and obstructive atherosclerosis of iliac-femoral arteries, which is common in the elderly population treated by TAVI, and small vessel diameter and tortuosity may often hinder safe positioning of large delivery catheters (16-24 F). In particular, the sheath to femoral artery ratio, independently predicts the Valve Academic Research Consortium (VARC) major vascular complications and 30-d mortality, with an identified cut-off of 1.05[13]. Furthermore, intravascular manipulation of these large catheters increases the risk of vascular injury, even in arteries with more friendly characteristics. Therefore, an accurate, pre-interventional screening of vascular anatomy using angiography or multidetector computed tomography (MDCT) of iliac-femoral arteries is mandatory for TAVI, to assess the presence and severity of atherosclerotic disease and determine the feasibility of an arterial approach[14]. Ideally, iliac-femoral arteries should be free of heavily calcified plaques and significant tortuosity, and with a diameter large enough to accommodate a large femoral sheath[13,15]. In comparison with standard angiography, the multiplanar capabilities of MDCT allow a detailed and complete three-dimensional assessment of the iliac-femoral system[16]. In addition to the accurate measurement of minimal lumen diameters, MDCT can assess vessel tortuosity, burden and pattern of calcification, extent of atherosclerosis, and identify other high-risk features including dissections and complex atheroma. During the procedure, fluoroscopic guidance while advancing the large diameter sheaths and delivery catheters is mandatory in order to check their navigation through complex vessel features. Ultrasound (US) guidance during positioning of these devices can help in identifying the optimal common femoral artery (CFA) puncture site and has been suggested to reduce access site complications[17]. In a multicenter randomized controlled trial, routine real-time US guidance compared with standard fluoroscopic guidance improved CFA cannulation only in patients with high CFA bifurcations, but improved first-pass success rate and reduced the number of attempts, time to access, risk of venipuncture, and vascular complications in all cases[18].
HEMOSTASIS TECHNIQUES USED IN TAVI
After an initial phase of surgical access site preparation and closure of vascular access, which is still to be considered in particular cases of alternative access (e.g., transubclavian access), operators have become confident with percutaneous puncture and access site closure through commercially available suture-mediated closure devices, such as the Prostar XL10F and Perclose ProGlide (Abbott Vascular Devices, Redwood City, CA, United States) devices[19,20]. Classical surgical preparation of vascular access can be quite difficult and time-consuming, especially in patients with heavily calcified vessels and/or previous groin interventions. It is characterized by a circumferential vessel dissection, arteriotomy, clamping, and wall closure. In all these phases vascular access complications such as plaque disruption, local dissection, aneurysm formation, stenosis/occlusion, and even acute thrombosis, with consequent acute limb ischemia, can occur[21,22]. Moreover, the lesser invasive percutaneous method in an experienced center is associated with similar rates of major and minor vascular complications[23] and with lower access site infection and bleeding, and shorter hospital stay compared to the surgical approach[24].
While the Edwards SAPIEN valve is implanted through a 22 or 24 F arterial sheath (about 8 and 9 mm external diameter), the CoreValve and the Edwards SAPIEN XT valve are delivered through a 16-20 F sheath (about 7 mm external diameter). These bulky sheaths are above the “on label” use of both suture-based hemostatic devices like the Prostar XL and Perclose ProGlide. So the “preclosure” technique has been developed to allow achievement of a full percutaneous hemostasis using such devices. The “preclosure” technique is based on the application of these devices to deploy sutures before the introduction of the large arterial sheath needed for valve implantation, then the sutures are tied at the end of the procedure by pushing down knot(s) in order to achieve hemostasis percutaneously. The sequence of steps necessary for successful “preclosure” technique is depicted in Figure 1. Recently, Kahlert et al[25] reported that ‘‘preclosure’’ with a single ProGlideTM device, followed by manual compression, could provide a more efficient and safe hemostasis compared to multiple ProGlideTM and Prostar XL techniques.
Figure 1 Pre-closure technique for hemostasis in transcatheter aortic valve implantation procedures.
After angiography-guided puncture of the anterior wall of the common femoral artery (CFA) and the insertion of a 6 F sheath, the preparation of vascular access for large sheath insertion (≥ 18 F) consists of the enlargement of the access site by the insertion of a 9 F sheath (A) and dilation of the subcutaneous tissue anteriorly (B) and posteriorly to the sheath (C), using one finger. Such a maneuver should achieve a less traumatic flaring of cutaneous and subcutaneous tissues at the vascular access site and create appropriate space for both large sheath introduction at the beginning of the procedure and optimal fastening of knots over the arterial wall at procedure end (D). After 9 F sheath removal, the suture-mediated vascular closure device is inserted in the correct position, the needles are unlocked and pulled through the arterial wall (E). At the end of transcatheter aortic valve implantation, the sheath and the guide wire are removed, the sutures are fastened individually with a sliding knot and a knot pusher is used to ensure approximation of the knot to the surface of the vessel wall. Vascular suture ends are cut well beneath the surface of the skin and an optimal closure of vascular access is obtained by a single cutaneous suture without residual bleeding (F).
The Prostar XL device was originally designed for a suture-based 10 F arteriotomy closure. However, it is commonly used for closing arterial access sites up to 18 F using the preclosure technique[26]. The device is a suture-mediated vascular closure system and is composed of a 10 F, 0.038-inch guidewire-compatible, hydrophilic sheath with a J-tip and a monorail design, based on two sutures (USP 3-0 braided polyester) and two pairs of nitinol needles, a needle guide, and a rotating barrel precisely controlling the needles during device deployment. After angiography-guided puncture of the anterior wall of the common femoral artery at an angle of approximately 45°, the Prostar XL is advanced over a 0.035-inch guidewire. When the device is in the correct position, indicated by pulsatile blood return from the dedicated marker lumen, the needles are unlocked and pulled through the arterial wall. After deployment of the device, the sutures are secured with mosquito clamps. At the end of the TAVI procedure, the sheath and the guide wire are removed while proximal pressure is maintained, and sutures are fastened individually with a (manually performed) sliding knot. A knot pusher is used to ensure approximation of the knot to the surface of the vessel wall. Manual pressure is then released and suture ends are cut well beneath the surface of the skin. A single Prostar XL is generally used to close arteriotomies for 18 to 19 F sheaths and two devices for 22- and 24 F sheaths at a 45° angle. It has been demonstrated to be a safe and effective method of achieving hemostasis, and to reduce times to ambulation and discharge after interventional procedures in a multicenter, non-randomized registry[26].
The Perclose ProGlide is a 6 F suture-based hemostatic device consisting of a monofilament suture and a pre-formed knot. To obtain hemostasis after removal of large sheaths, two Perclose devices are used according to the “double preclosure technique”. This consists of the sequential insertion of the two Perclose devices rotated in opposite sides at 30°-45°, to create an interrupted X-figure and then closure of the arteriotomy is achieved at the end of the procedure by tying down the two knots using the two node pushers sequentially[27]. According to recent data, this technique has been suggested to be associated with a low incidence of early and late closure site complications[28-30]. Furthermore, the use of three Perclose devices has recently been reported[19].
Finally, a potentially useful adjunctive technique (which may eventually be used in conjunction with the above-mentioned closure device-based techniques) to improve efficacy of hemostasis, is the crossover balloon occlusion technique (CBOT). This consists of the reduction of local blood pressure at the entry level of the large sheath through flow blockage obtained by inflation of a peripheral angioplasty balloon in the iliac artery using the crossover technique. The CBOT has been reported to allow safe and successful percutaneous closure in patients undergoing TAVI via a retrograde femoral artery approach using the 22 or 24 F sheath systems[31].
NOVEL VASCULAR SHEATHS FOR TRANSFEMORAL TAVI
More recently, a novel type of sheath has been developed to reduce the rate of vascular complications related to TAVI. The SoloPath™ (Onset Medical, Terumo Medical Corporation, Irvine, CA, United States) is a balloon expandable transfemoral introducer; it has an inner diameter of 14-21 F (outer diameter 17-24 F) and is compatible with the 18 F Medtronic/CoreValve and the 23- and 26-mm Edward SAPIEN XT delivery system. Its peculiarity is represented by a 13.5 F distal part to facilitate vessel entry, that can be expanded by the integrated balloon inflation reaching its nominal diameter, after sheath insertion, and can be deflated at the end of the procedure, enabling low-resistance removal[32,33]. The SoloPath sheath is a feasible alternative to conventional sheaths for transfemoral TAVR patients with advanced atherosclerotic disease or an arterial diameter ≤ 7 mm[34]. The available expandable sheath for Edwards Sapien XT valve is the e-Sheath™ (Edwards Lifesciences, Irvine, California, United States), a 16-18 F sheath, with a “dynamic expansion mechanism” to facilitate the valve passage, which returns to a reduced profile once the valve has passed, limiting vascular trauma. Nevertheless, this device is contraindicated for tortuous or calcified vessels, which would prevent safe entry of the sheath, and currently does not show an advantage over the 18/19 F fixed size sheath in reducing vascular and bleeding complications[35].
VASCULAR ACCESS SITE COMPLICATIONS AFTER TAVI AND THEIR MANAGEMENT
A series of vascular complications are commonly reported to be associated with TAVI, including arterial perforation, dissection, pseudoaneurysm, stenosis/occlusion and arterio-venous fistula[7-10]. The VARC, a collaboration between academic research organizations in the United States and Europe, has elaborated a consensus document on TAVI related endpoint definitions[36] and a more recent updated document[37], in which a classification of major and minor vascular access complications has been proposed (Table 1). This position paper has also provided a clear definition for the “access-related” complications, which were defined as any adverse clinical event possibly associated with any of the access sites used during the procedure[38].
Table 1 Valve academic research consortium-2 classification of vascular access site and access-related complications.
Major vascular complications
Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm OR
Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure) leading to death, life-threatening or major bleeding1, visceral ischemia or neurological impairment OR
Distal embolization (non-cerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage OR
The use of unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischemia or neurological impairment OR
Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower ex tremity angiogram OR
Surgery for access site-related nerve injury OR
Permanent access site-related nerve injury
Minor vascular complications
Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysms , hematomas, percutaneous closure device failure) not leading to death, life-threatening or major bleeding1, visceral ischemia or neurological impairment OR
Distal embolization treated with embolectomy and/or thrombectomy and not resulting in amputation or irreversible end-organ damage OR
Any unplanned endovascular stenting or unplanned surgical intervention not meeting the criteria for a major vascular complication OR
Vascular repair or the need for vascular repair (via surgery, ultrasound-guided compression, transcatheter embolization, or stent-graft)
Percutaneous closure device failure
Failure of a closure device to achieve hemostasis at the arteriotomy site leading to alternative treatment (other than manual compression or adjunctive endovascular ballooning)
Vascular access site complication rates reported in the literature are extremely variable probably because of different valve delivery systems[39], closure techniques and learning curves. To provide an overview of vascular complication frequency and type, a summary of the main published studies on TAVI-related vascular access site complications is provided in Table 2.
Table 2 Incidence of major vascular access site complications and specific vascular access site types across transfemoral transcatheter aortic valve implantation studies.
Spanish National Registry of TAVI[56], Rev Esp Cardiol 2013
ESV + MCV
1159 504 ESV 610 MCV
42/1159 (3.6%) 25/504 (5%) 17/610 (2.8%)
NA
NA
NA
NA
Total
12862
640/12862 (5%)
18/143 (12.6%)
44/207 (21.2%)
69/207 (33.3%)
10/207 (4.8%)
Optimization of hemostasis techniques and management strategies are probably pivotal. The optimal management of vascular access site complications includes a prompt diagnosis and appropriate timely treatment. At the end of the procedure, digital subtraction angiography of the iliac-femoral arteries obtained using a non-selective (via a pigtail catheter introduced in the aorta through the contralateral femoral artery) or a selective (via a diagnostic right Judkins or internal mammary artery catheter placed from the contralateral femoral artery according to the “crossover” technique) contrast injection is advisable to assess the vascular integrity and promptly manage possible complications. Percutaneous management of vascular complications after TAVI as a bailout procedure is feasible and safe, with a high rate of technical success, and long-term clinical outcomes are comparable to patients without vascular complications[57].
A wide range of vascular damage (from minor vessel complications such as localized femoral artery dissection to major complications such as vessel occlusion or perforation) has been described. Localized vascular damage without any impairment of lower limb perfusion should be treated conservatively, with careful clinical and ultrasonographic monitoring during the following hours. The main vascular access site complications reported in TAVI studies are: pseudoaneurysm, arterial perforation, arterial dissection, occlusion and avulsion. The specific management strategies are herein discussed for each of these complications.
Pseudoaneurysm
Pseudoaneurysm consists of a pulsatile hematoma which communicates with an artery through a disruption in the arterial wall. At the end of the procedure, standard or digital subtraction angiography of the iliac-femoral arteries can reveal an arterial leak as a precursor of the pseudoaneurysm or a true pseudoaneurysm (as shown in Figure 2), depending on the time of formation. If angiographic diagnosis has not been made after the end of the procedure, close clinical surveillance can detect the increase in a new thrill or bruit, pulsatile hematoma, or marked pain or tenderness, and pseudoaneurysm can be confirmed by ultrasound. Possible complications of pseudoaneurysm are rupture, distal embolization, infection, neuropathy and local skin ischemia. However, it generally does not impair lower limb perfusion and can be treated by ultrasound-guided compression, which is a safe and cost-effective method of achieving pseudoaneurysm thrombosis[58]. However, it carries considerable drawbacks including long procedure times, patient discomfort and high recurrence rates, especially in cases requiring anticoagulant therapy. If probe compression fails, treatment options include ultrasound-guided thrombin injection, which is associated with a high success rate and is more comfortable for patients[59], coil embolization, stent graft and surgical repair.
Figure 2 Post-transcatheter aortic valve implantation pseudoaneurysm.
After the transcatheter aortic valve implantation procedure, digital subtraction angiography of the left iliac-femoral artery by contralateral medium contrast injection showing a pseudoaneurysm of the left common femoral artery.
Another vascular complication of TAVI is iliac-femoral stenosis, which is sometimes associated with closure device release. Mild stenosis detected by angiography in the absence of lower limb ischemia may be managed conservatively, while a significant stenosis may be treated by percutaneous transluminal angioplasty (PTA) (Figure 3), with the aim of preventing further flow deterioration in the limb by superimposition of thrombosis or development of severe post-procedural claudication. When hemostatic device-induced tight stenosis is detected immediately after large sheath removal and urgent PTA is needed at procedure end, the selection of undersized peripheral balloons is advisable in order to avoid arterial wall laceration by suture knots.
Figure 3 Post-transcatheter aortic valve implantation common femoral artery stenosis.
Standard angiography obtained before 18 F sheath insertion for transcatheter aortic valve implantation showed the absence of significant stenosis, tortuosity and calcification of left iliac-femoral artery (A); after vascular access closure by Prostar XL, angiography documented the presence of an intimal flap in the right common femoral artery (CFA) wall, not determining a significant flow limitation (B); 4-mo follow-up angiography showed progression of arterial damage and the development of significant stenosis of CFA, determining claudication (Fontaine-Leriche class IIb) (C); angioplasty of left CFA was performed by right transradial access, using a 125 cm 6 F Multipurpose guiding catheter and a 300 cm BMW Universal wire; a 4.0 mm x 15 mm non-compliant coronary balloon (NC Sprinter, Medtronic, North Carolina, United States) and a 6.0 mm x 20 mm peripheral balloon (Avion Plus, Invatec, Roncadelle, Italy) were inflated to 24 atm, obtaining an optimal final result (D).
Perforation
Perforation leading to retroperitoneal hematoma is a dramatic complication of TAVI. It can be identified by angiography performed before removal of the large sheath or can appear only after sheath removal (since the sheath is usually occlusive at the level of the external iliac and femoral arteries), as well as after tying the closure device knots. After arterial perforation visualization by angiography, timely bleeding control may be obtained by the positioning of an occlusive balloon proximal to the vascular lesion site or insertion of a large sheath across the lacerated segment. To facilitate bleeding control, operators can use protamine to neutralize heparin action. If arterial laceration persists after balloon or sheath removal, percutaneous implantation of a covered stent can be performed in order to avoid the risks related with urgent vascular surgery (Figure 4). Moreover, post-procedure digital subtraction angiography of the iliac-femoral arteries can also allow detection of rarer complications with insidious diagnosis such as lateral circumflex femoral artery perforation. While femoral artery perforation is most often related to closure device failure and can cause a visible leg hematoma, iliac artery perforation may cause a retroperitoneal hematoma in the hours after the procedure, which may be suggested by low back pain and can be confirmed by CT, and can be managed by prolonged balloon inflation or coil embolization.
Figure 4 Post-transcatheter aortic valve implantation arterial perforation.
At the end of the transcatheter aortic valve implantation procedure, digital subtraction angiography of the right iliac-femoral artery showed a perforation of the right common femoral artery (CFA) (A); angioplasty of the right CFA was performed by the crossover approach via the contralateral iliac-femoral artery; a 7.0 mm x 40 mm peripheral balloon (Admiral Xtreme, Invatec, Roncadelle, Italy) was inflated to 10 atm at the perforation site (B); because of the persistence of hematic extravasation, a 8.0 mm x 60 mm covered stent (Fluency Stent-Graft, BARD Peripheral Vascular, AZ, United States) was implanted, followed by dilation of 7.0 mm x 40 mm and 8.0 mm x 20 mm balloons (Admiral Xtreme, Invatec, Roncadelle, Italy) to 12 atm. At final angiography, optimal sealing of the arterial breach without residual hematic extravasation was documented (C).
Dissection
Dissection of the iliac-femoral arteries can occur as a consequence of excessively traumatic sheath insertion through fragile/diseased arterial vessels. Limited, non-occlusive and retrograde arterial dissections may generally be managed conservatively, since the antegrade flow generally maintains the artery patency, pushing the dissection flap to the vessel wall. More extensive arterial dissection can be associated with vessel occlusion (due to superimposed acute thrombosis or obstructive flaps), and may cause acute limb ischemia, so prompt management is needed to restore antegrade flow. Percutaneous angioplasty and self- or balloon-expandable stent implantation can allow successful management by the crossover technique through the contralateral femoral artery (Figures 5 and 6). A valuable tip to reduce the incidence of vascular wall lacerations is to pay particular attention to vascular calcification movement during a large sheath insertion. If the operator notes a certain resistance during this maneuver, it is advisable to insert the sheath slowly stopping every two centimeters, and to use a substance to reduce friction such as sterile Vaseline. At the end of TAVI, extraction of the introducer after dilator insertion is preferable to avoid traumatic action of the introducer’s tip on arterial walls, especially in sharp arterial turns.
Figure 5 Post-transcatheter aortic valve implantation arterial dissection.
Post- transcatheter aortic valve implantation procedure, angiography of the right iliac-femoral axis via the contralateral groin showing a dissection of the right common femoral artery extending proximally to the external iliac artery and determining distally an occlusion of the superficial femoral artery (A); digital subtraction angiography after reaching true lumen by a .035” wire by the retrograde approach and peripheral balloon dilation (6.0 mm x 120 mm Admiral Xtreme, Invatec, Roncadelle, Italy) to 6 atm (B); final angiography after stenting (6.0 mm x 80 mm and 9.0 mm x 60 mm Lifestent Vascular Stent, BARD Peripheral Vascular, AZ, United States) and post-dilation (5.0 mm x 80 mm and 6.0 mm x 120 mm Admiral Xtreme; Invatec, Roncadelle, Italy) showing an optimal antegrade flow in the right iliac-femoral artery (C).
Figure 6 Post-transcatheter aortic valve implantation arterial thrombosis.
Post-transcatheter aortic valve implantation procedure, digital subtraction angiography showing acute thrombotic occlusion of the right common femoral artery (A); emergency percutaneous transluminal angioplasty was performed by the crossover approach via the contralateral femoral artery, and consisted of initial thromboaspiration using a 6 F Multipurpose guiding catheter (Vista Brite Tip, Cordis Inc., Miami Lakes, FL, United States), obtaining restoration of antegrade blood flow (B); after prolonged dilations by 5.0 mm × 40 mm and 6.0 mm × 40 mm balloons (Pacific Xtreme and Admiral Xtreme, Invatec, Roncadelle, Italy), a 7.0 mm × 20 mm stent (Cristallo Ideale, Invatec, Roncadelle, Italy) was implanted, dilated by a 7.0 mm × 30 mm balloon (Avion Plus, Invatec, Roncadelle, Italy) to 10 atm. Final angiography showed the absence of residual stenosis (C).
A rare complication of large artery sheath use is arterial avulsion followed by massive hemorrhage. This event is related to the tendency of the large femoral sheath to adhere to endothelium. If there is a suspicion of this dreadful complication due to resistance in sheath withdrawal, the placement of an occlusive balloon in the abdominal aorta under the renal arteries and preparation for possible surgical repair is the only option to save the patient’s life[60].
A particular category of vascular access complications is represented by closure device failure, which is considered separately in the new VARC-2 classification[37]. Vascular closure device failure is not uncommon and can cause arterial dissection, perforation and occlusion. For example in a study by Van Mieghem et al[7], in the setting of transfemoral TAVI using the Medtronic CoreValve prosthesis, Prostar XLTM failure was responsible for about 54% of the observed major vascular events. Patient characteristics such as excessive femoral artery calcification, female gender and obesity[61], and the operator’s learning curve[62] in deploying the closure devices can contribute to these events. As for the other vascular complications, closure-related complications can be managed conservatively by manual compression if there is no impairment of blood flow and leg perfusion, vice versa if there is continuous access site bleeding or significant artery stenosis or occlusion, they can be treated interventionally by PTA.
As discussed above, the prompt adoption of simple endovascular techniques may help to manage the majority of vascular complications, thus avoiding the risks of urgent vascular surgery. In Table 3 an “operative” list of the endovascular materials which may be used for bailout endovascular interventions (through contralateral femoral access using “crossover” technique) is provided.
Table 3 Materials for bailout endovascular interventions to manage vascular access complications (through contralateral femoral access using the “crossover” technique).
Complication
Type of bailout endovascular intervention
Devices needed
Any type
Immediate angiography and prompt access to the affected iliac-femoral axis1
6-9 F long (45 cm) sheaths
Iliac-femoral arteries rupture/ perforation
Immediate hemostasis to avoid shock
Large peripheral balloons in iliac arteries (diameter: 7-10 mm) or elastomeric balloon in the distal aorta
Vascular sealing in case of persistent blood extravasation after prolonged balloon inflation
Covered stent (diameter: 7-10 mm)
Failure of hemostasis at the entry site
Prolonged balloon inflation proximal to the entry site during external manual compression
Mid-sized peripheral balloons (diameter: 6-8 mm)
Iliac-femoral arteries flow-limiting dissection
Immediate restoration of antegrade flow to avoid acute limb ischemia
Large peripheral balloons (diameter: 7-10 mm)
Vascular sealing in case of significant stenosis/dissection after balloon inflation
Immediate restoration of antegrade flow to avoid acute limb ischemia
Thrombus aspiration with thrombus-extraction devices (angiojet, thrombus-aspirating catheters) or with coronary guiding catheters (multipurpose curve) Peripheral balloons (diameter: 5-10 mm) Consider distal filter protection to avoid embolization and avoid aggressive dilations since dethrombosis is usually facilitated by antegrade flow restoration
CONCLUSION
Vascular complications are not rare in TAVI by the transfemoral approach and can significantly affect the overall clinical outcome[8-10]. At the end of the TAVI procedure, a control angiography obtained from the contralateral femoral access site allows early identification of vascular access site complications. After diagnosis, the application of simple vascular interventional techniques allows efficient complication management, thus avoiding high risk vascular surgery.
Footnotes
P- Reviewer: Armstrong EJ, Bilotta F, Lazzeri C, Sabate M S- Editor: Ji FF L- Editor: A E- Editor: Wu HL
Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Nercolini D, Tapiero S, Litzler PY, Bessou JP, Babaliaros V. Treatment of calcific aortic stenosis with the percutaneous heart valve: mid-term follow-up from the initial feasibility studies: the French experience.J Am Coll Cardiol. 2006;47:1214-1223.
[PubMed] [DOI][Cited in This Article: ]
Tamburino C, Barbanti M, Capodanno D, Mignosa C, Gentile M, Aruta P, Pistritto AM, Bonanno C, Bonura S, Cadoni A. Comparison of complications and outcomes to one year of transcatheter aortic valve implantation versus surgical aortic valve replacement in patients with severe aortic stenosis.Am J Cardiol. 2012;109:1487-1493.
[PubMed] [DOI][Cited in This Article: ][Cited by in Crossref: 48][Cited by in F6Publishing: 52][Article Influence: 4.3][Reference Citation Analysis (0)]
Généreux P, Head SJ, Van Mieghem NM, Kodali S, Kirtane AJ, Xu K, Smith C, Serruys PW, Kappetein AP, Leon MB. Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions: a weighted meta-analysis of 3,519 patients from 16 studies.J Am Coll Cardiol. 2012;59:2317-2326.
[PubMed] [DOI][Cited in This Article: ][Cited by in Crossref: 420][Cited by in F6Publishing: 443][Article Influence: 36.9][Reference Citation Analysis (0)]
Van Mieghem NM, Nuis RJ, Piazza N, Apostolos T, Ligthart J, Schultz C, de Jaegere PP, Serruys PW. Vascular complications with transcatheter aortic valve implantation using the 18 Fr Medtronic CoreValve System: the Rotterdam experience.EuroIntervention. 2010;5:673-679.
[PubMed] [DOI][Cited in This Article: ]
Ducrocq G, Francis F, Serfaty JM, Himbert D, Maury JM, Pasi N, Marouene S, Provenchère S, Iung B, Castier Y. Vascular complications of transfemoral aortic valve implantation with the Edwards SAPIEN prosthesis: incidence and impact on outcome.EuroIntervention. 2010;5:666-672.
[PubMed] [DOI][Cited in This Article: ]
Tchetche D, Dumonteil N, Sauguet A, Descoutures F, Luz A, Garcia O, Soula P, Gabiache Y, Fournial G, Marcheix B. Thirty-day outcome and vascular complications after transarterial aortic valve implantation using both Edwards Sapien and Medtronic CoreValve bioprostheses in a mixed population.EuroIntervention. 2010;5:659-665.
[PubMed] [DOI][Cited in This Article: ]
Van Mieghem NM, Tchetche D, Chieffo A, Dumonteil N, Messika-Zeitoun D, van der Boon RM, Vahdat O, Buchanan GL, Marcheix B, Himbert D. Incidence, predictors, and implications of access site complications with transfemoral transcatheter aortic valve implantation.Am J Cardiol. 2012;110:1361-1367.
[PubMed] [DOI][Cited in This Article: ][Cited by in Crossref: 172][Cited by in F6Publishing: 190][Article Influence: 15.8][Reference Citation Analysis (0)]
de Jaegere P, van Dijk LC, Laborde JC, Sianos G, Orellana Ramos FJ, Lighart J, Kappetein AP, Vander Ent M, Serruys PW. True percutaneous implantation of the CoreValve aortic valve prosthesis by the combined use of ultrasound guided vascular access, Prostar(R) XL and the TandemHeart(R).EuroIntervention. 2007;2:500-505.
[PubMed] [DOI][Cited in This Article: ]
Haas PC, Krajcer Z, Diethrich EB. Closure of large percutaneous access sites using the Prostar XL Percutaneous Vascular Surgery device.J Endovasc Surg. 1999;6:168-170.
[PubMed] [DOI][Cited in This Article: ]
Bunt TJ, Manship L, Moore W. Iatrogenic vascular injury during peripheral revascularization.J Vasc Surg. 1985;2:491-498.
[PubMed] [DOI][Cited in This Article: ]
Aljabri B, Obrand DI, Montreuil B, MacKenzie KS, Steinmetz OK. Early vascular complications after endovascular repair of aortoiliac aneurysms.Ann Vasc Surg. 2001;15:608-614.
[PubMed] [DOI][Cited in This Article: ]
Nasu K, Tsuchikane E, Sumitsuji S. Clinical effectiveness of the Prostar XL suture-mediated percutaneous vascular closure device following PCI: results of the Perclose AcceleRated Ambulation and DISchargE (PARADISE) Trial.J Invasive Cardiol. 2003;15:251-256.
[PubMed] [DOI][Cited in This Article: ]
Nasu K, Tsuchikane E, Sumitsuji S, Tsuji T, Tamai H. The safety and efficacy of “pre-closure” utilizing the Closer suture-mediated vascular closure device for achievement of hemostasis in patients following coronary interventions: results of the second Perclose Accelerated Ambulation and Discharge (PARADISE II) Trial.J Invasive Cardiol. 2005;17:30-33.
[PubMed] [DOI][Cited in This Article: ]
Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein AP, Krucoff MW, Mack M, Mehran R, Miller C. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium.Eur Heart J. 2011;32:205-217.
[PubMed] [DOI][Cited in This Article: ][Cited by in Crossref: 486][Cited by in F6Publishing: 504][Article Influence: 38.8][Reference Citation Analysis (0)]
Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.Eur Heart J. 2012;33:2403-2418.
[PubMed] [DOI][Cited in This Article: ][Cited by in Crossref: 736][Cited by in F6Publishing: 825][Article Influence: 75.0][Reference Citation Analysis (0)]
Neragi-Miandoab S, Salemi A. The most relevant complications of transcatheter aortic valve implantation according to VARC criteria.Minerva Cardioangiol. 2014;62:205-220.
[PubMed] [DOI][Cited in This Article: ]
Piazza N, Grube E, Gerckens U, den Heijer P, Linke A, Luha O, Ramondo A, Ussia G, Wenaweser P, Windecker S. Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr) corevalve revalving system: results from the multicentre, expanded evaluation registry 1-year following CE mark approval.EuroIntervention. 2008;4:242-249.
[PubMed] [DOI][Cited in This Article: ]
Himbert D, Descoutures F, Al-Attar N, Iung B, Ducrocq G, Détaint D, Brochet E, Messika-Zeitoun D, Francis F, Ibrahim H. Results of transfemoral or transapical aortic valve implantation following a uniform assessment in high-risk patients with aortic stenosis.J Am Coll Cardiol. 2009;54:303-311.
[PubMed] [DOI][Cited in This Article: ][Cited by in Crossref: 210][Cited by in F6Publishing: 218][Article Influence: 14.5][Reference Citation Analysis (0)]
Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H, Eggebrecht H, Rubino P, Michev I, Lange R. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve.Circulation. 2010;122:62-69.
[PubMed] [DOI][Cited in This Article: ][Cited by in Crossref: 663][Cited by in F6Publishing: 641][Article Influence: 45.8][Reference Citation Analysis (0)]
Rodés-Cabau J, Webb JG, Cheung A, Ye J, Dumont E, Feindel CM, Osten M, Natarajan MK, Velianou JL, Martucci G. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience.J Am Coll Cardiol. 2010;55:1080-1090.
[PubMed] [DOI][Cited in This Article: ][Cited by in Crossref: 770][Cited by in F6Publishing: 760][Article Influence: 54.3][Reference Citation Analysis (0)]
Eltchaninoff H, Prat A, Gilard M, Leguerrier A, Blanchard D, Fournial G, Iung B, Donzeau-Gouge P, Tribouilloy C, Debrux JL. Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry.Eur Heart J. 2011;32:191-197.
[PubMed] [DOI][Cited in This Article: ][Cited by in Crossref: 405][Cited by in F6Publishing: 405][Article Influence: 28.9][Reference Citation Analysis (0)]
Avanzas P, Muñoz-García AJ, Segura J, Pan M, Alonso-Briales JH, Lozano I, Morís C, Suárez de Lezo J, Hernández-García JM. Percutaneous implantation of the CoreValve self-expanding aortic valve prosthesis in patients with severe aortic stenosis: early experience in Spain.Rev Esp Cardiol. 2010;63:141-148.
[PubMed] [DOI][Cited in This Article: ]
Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, Young CP, Thomas M, Kovac J, Spyt T, MacCarthy PA. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry.J Am Coll Cardiol. 2011;58:2130-2138.
[PubMed] [DOI][Cited in This Article: ][Cited by in Crossref: 686][Cited by in F6Publishing: 683][Article Influence: 52.5][Reference Citation Analysis (0)]
Di Mario C, Eltchaninoff H, Moat N, Goicolea J, Ussia GP, Kala P, Wenaweser P, Zembala M, Nickenig G, Alegria Barrero E. The 2011-12 pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation: in-hospital results in 4,571 patients.EuroIntervention. 2013;8:1362-1371.
[PubMed] [DOI][Cited in This Article: ][Cited by in Crossref: 133][Cited by in F6Publishing: 143][Article Influence: 13.0][Reference Citation Analysis (0)]
Sawa Y, Saito S, Kobayashi J, Niinami H, Kuratani T, Maeda K, Kanzaki H, Komiyama N, Tanaka Y, Boyle A. First clinical trial of a self-expandable transcatheter heart valve in Japan in patients with symptomatic severe aortic stenosis.Circ J. 2014;78:1083-1090.
[PubMed] [DOI][Cited in This Article: ]
Sabaté M, Cánovas S, García E, Hernández Antolín R, Maroto L, Hernández JM, Alonso Briales JH, Muñoz García AJ, Gutiérrez-Ibañes E, Rodríguez-Roda J. In-hospital and mid-term predictors of mortality after transcatheter aortic valve implantation: data from the TAVI National Registry 2010-2011.Rev Esp Cardiol (Engl Ed). 2013;66:949-958.
[PubMed] [DOI][Cited in This Article: ][Cited by in Crossref: 3][Cited by in F6Publishing: 15][Article Influence: 1.4][Reference Citation Analysis (0)]
Eisenberg L, Paulson EK, Kliewer MA, Hudson MP, DeLong DM, Carroll BA. Sonographically guided compression repair of pseudoaneurysms: further experience from a single institution.AJR Am J Roentgenol. 1999;173:1567-1573.
[PubMed] [DOI][Cited in This Article: ]
Quarmby JW, Engelke C, Chitolie A, Morgan RA, Belli AM. Autologous thrombin for treatment of pseudoaneurysms.Lancet. 2002;359:946-947.
[PubMed] [DOI][Cited in This Article: ]
Laganà D, Carrafiello G, Mangini M, Giorgianni A, Lumia D, Cuffari S, Fugazzola C. Emergency percutaneous treatment of arterial iliac axis ruptures.Emerg Radiol. 2007;14:173-179.
[PubMed] [DOI][Cited in This Article: ]
Hayashida K, Lefèvre T, Chevalier B, Hovasse T, Romano M, Garot P, Mylotte D, Uribe J, Farge A, Donzeau-Gouge P. True percutaneous approach for transfemoral aortic valve implantation using the Prostar XL device: impact of learning curve on vascular complications.JACC Cardiovasc Interv. 2012;5:207-214.
[PubMed] [DOI][Cited in This Article: ][Cited by in Crossref: 87][Cited by in F6Publishing: 91][Article Influence: 7.6][Reference Citation Analysis (0)]
