Percutaneous management of vascular access in transfemoral transcatheter aortic valve implantation

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)

¹Refers to valve academic research consortium bleeding definitions[37].

Table 2 Incidence of major vascular access site complications and specific vascular access site types across transfemoral transcatheter aortic valve implantation studies

Ref.	Bioprostheses	Population	Major vascular complications	Stenosis/ occlusion	Perforation/rupture	Dissection	Pseudoaneurysm
Webb et al[40], Circulation 2009	ESV	113	9/113 (8%)	NA	NA	NA	NA
Ducrocq et al[8], Eurointervention 2010	ESV	54	9/54 (16.7%)	0/9	5/9 (55.5%)	4/9 (45.5%)	0/9
Tchetche et al[9], Eurointervention 2010	ESV + MCV	45 24 ESV 21 MCV	4/45 (8.9%) 2/24 (8.3%) ESV 2/21 (9.5%) MCV1	NA	NA	NA	NA
Piazza et al[41], Eurointervention 2008	MCV	646	12/646 (1.9%)	NA	NA	NA	NA
Himbert et al[42], JACC 2009	ESV	51	6/51 (12%)	0/6	2/6 (33%)	4/6 (66%)	0/6
Webb et al[1], Circulation 2007	ESV	50	4/50 (8%)	0/4	4/4 (100%)	0/4	0/4
SOURCE registry[43], Circulation 2009	ESV	463	57/463 (12.3%)	NA	NA	NA	NA
Lefèvre et al[44], Eur Heart J 2011	ESV	61	17/61 (28%)	0/61	3/61 (5%)	6/61 (10%)	1/161 (2%)
Canadian experience[45], JACC 2010	ESV	168	22/168 (13.1%)	NA	NA	NA	NA
Bleiziffer et al[46], J ThoracCardiovasc Surg 2009	MCV	153	24/153 (16%)	NA	NA	NA	NA
The Milan experience JACC Cardiovasc Interv 2010[47]	ESV + MCV	107 61 ESV 46 MCV	22 /107 (20.6%) 13/61 (21.3%) ESV 9/46 (19.5%) MCV1	1/22 (4.5%) ESV	7/22 (32%) 5/13 (38%) ESV 2/9 (22%) MCV1	6/22 (27%) 4/13 (31%) ESV 2/9 (22%) MCV1	4/22 (18%) MCV
The Rotterdam experience[7], Eurointervention 2010	MCV	99	13/99 (13%)	NA	NA	NA	NA
The France Registry[48], Eur Heart J 2011	ESV + MCV	160 94 ESV 66 MCV	11/160 (7%) 6/94 (6.4%) ESV 5/66 (7.6%) MCV1	0/11	2/11 (18%) ESV	7/11 (64%) 4/6 (67%) ESV 3/5 (60 %) MCV1	0/11
Petronio et al[49], Circ Cardiovasc Interv 2010	MCV	460	9/460 (2%)	NA	NA	NA	NA
Spanish experience[50], Rev Espan Cardiol 2010	MCV	108	6/108 (5.6%)	1/6 (16.6%)	1/6 (16.6%)	0/6	1/6 (6.60%)
United Kingdom Registry[51], JACC 2011	ESV + MCV	599 193 ESV 406 MCV	50/599 (8.4%)	NA	NA	NA	NA
Toggweiler et al[15], JACC 2012	ESV+ MCV	137 126 ESV 11 MCV	24/137 (18%)2	16/24 (66.6%)	2/24 (8.3%)	2/24 (8.3%)	2/24 (8.3%)
Partner trial[52], JACC 2012	ESV	419	64/419 (15.3%)	NA	20/64 (31.3%)	40/64 (62.8%)	2/64 (3.4%)
The France II Registry[53], NEJM 2013	ESV + MCV	3195 2107 ESV 1043 MCV	150/3195 (4.7%) 57/2107 (2.7%) 47/1043 (4.5%)	NA	NA	NA	NA
European Sentinel Registry of TAVI[54], Eurointervention 2013	ESV + MCV	4571 2604 ESV3 1943 MCV	40/4571 (3.1%) 20/2604 (3.3%) 20/1943 (2.8%)	NA	NA	NA	NA
Sawa et al[55], Circulation Journal 2014	MCV	44	5/44 (11.54%)	NA	NA	NA	NA
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%)

¹P value not significant between ESV and MCV subgroups;

²Major plus minor complications;

³Including transapical (29% of total ESV). ESV: Edwards SAPIEN valve; MCV: Medtronic Core Valve.

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	Peripheral self-expandable nitinol stents (diameter: 7-10 mm)
Iliac-femoral arteries acute thrombotic occlusion	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

¹Provisional delivery of a sentinel wire (i.e., a 0.014”-0.018” wire placed in cross-over in distal femoral artery and jailed under the 18 F sheath) allows continuous control of the entry site and quick access to contralateral iliac-femoral axis if needed.