Cierre Percutáneo.
Hacia una estrategia minimalista en procedimientos endovasculares
• Oscar A. Mendiz.MD.FACC.FSCAI • Director Cardiology & Cardiovascular Institute (ICyCC)
• Chief Interventional Cardiology Department
• Board of Directors Hospital & Favaloro University
• TCT Associated Director
@omendiz www.fundacionfavaloro.com
Disclosure
• O Mendiz MD.
• Medtronic: Proctor CoreValve
• Abbott: Consultant
• AstraZeneca: Speaker
• Terumo: Consultant
• Cook: Consultant
• Endologix: Consultant
Big Bore Closure
• Relevance
• Patient Selection
• Tips & Tricks
• Closure Devices
• Solving Complications
Key issue for Minimalist approach
(structural & endovascular)
General anesthesia Not Needed
Comfort & Rapid Mobilization
Less complications rate (infections, seromas)
Big Bore Closure: Relevance
Généreux et al. JACC 2012;60:1043-52
Independent Predictors of 1-year Death After TAVR
• N = 419 patients treated with TF TAVR in PARTNER 1A and 1B (22/24-F systems)
• 64 suffered major vascular complications (modified VARC definition)
Sapien 3
Evolute R
Partner 1A & 1B
Kodali. Eur Heart J 2016.
Williams. ACC 2106
Généreux. JACC 2012.60:1043-52
Vascular Complications:
Carroll et al. J Am Coll Cardiol. 2017; 70(1): 29-41
Modified from P Generaux (tctmd.com)
Impact of Learning Curve on Major Vascular Complications
• N = 42, 988 patients in STS
registry (2011-2015)
• Using case sequencing,
outcome learning curves
defined by time to reach a
plateau in a given event
• Major vascular complications
reached a nadir at ~6% by
case 100
Big Bore Closure
• Relevance
• Patient Selection
• Tips & Tricks
• Closure Devices
• Solving Complications
Aorto, iliacs and Common Fem calcification.
Iliac diameter, tortuosity and stenosis.
Small branches at puncture site.
Choice of the best access side.
Choice of the material to be used.
Big Bore Closure: Pte Selection
Big Bore Closure: Pte Selection
• Severe obesity (Not ideal, but percutaneous preferred over cutdown).
• Severe calcification in CFA, iliac and aorta.
• Severe tortuosity.
• Disease in CFA.
• High bifurcation of the CFA (depending on SFA Diameter)
• Previous surgery of the CFA (EVAR).
• Small diameter of the CFA and Iliac.
Big Bore Closure
• Relevance
• Patient Selection
• Tips & Tricks
• Closure Devices
• Solving Complications
Big Bore Closure: Good Access is the First Stept to get a Good Closure
Goals for a Good Arterial Puncture:
• Common femoral artery entry
• Below inguinal ligament
• Anterior wall stick
• Avoid small branches
• Avoid CFA artery bifurcation
• Above (or away from, find a spot) areas of calcification
• Eco or Angio guided (pigtail)
Echo-guided Angio-guided
GOALS
Anterior wall puncture
CFA puncture
Below inguinal ligament
Avoid small branches
Avoid sites of severe calcification
Big Bore Closure: Good Puncture
Big Bore Closure: Safety Measures
Contralateral Approach:
• TAVR - EVAR (Endologic) or TEVAR
Others
• Superior approach: other EVAR Devices (if needed)
• Stent graft for Bailout
• Big elastomeric Balloons for Aortic Endovasc. Clamping
• Surgical back-up
Bleeding post
percutaneous closure
Long lasting balloon
insuflation
Complete
hemostasis
Big Bore Closure: Rescue Maneuvers
Stenosis post
percutaneous closure
Balloon dilatation Final result
Big Bore Closure: Rescue Maneuvers
Iliac perforation After stent graft implant
Percutaneous Approach means also being ready to solve complications
Unexpected Iliac Rupture
Normal iliac artery without calcification or
lesions Same patient after a successful valve
implantation
Iliac Perforation
Percutaneous Approach means also being ready to solve complications
Percutaneous Closure: Suture Devices
Courtesy of Abbott Vascular
Prostar
XL Perclose
10-F
Braided polyester sutures
2 sutures delivered simultaneously
from within the vessel
6-F
Monofilament polypropylene
suture
Single suture delivered from
outside the vessel
Comparing Closure Devices in TAVR CONTROL Study
Barbash et al. Eur Heart J. 2015 14;36(47):3370-9
• Multicenter study
• N = 472 propensity-matched pairs
(from 3,138 patients overall)
undergoing TF TAVR using Prostar
vs. Perclose
• Higher rates of major bleeding and
vascular complications with Prostar
• Longer hospital stay in Prostar group
• No difference in mortality
Outcome Prostar N = 472
Perclose N = 472
P value OR (95% CI)
Major vascular complications
35 (7.4%) 9 (1.9%) <0.001 4.25
Major bleeding 79 (16.7 %) 15 (3.2%) <0.001 6.33
Comparing Closure Devices in TAVR
Kiramijyan S et al. Eurointervention 2016 17;12(1):88-93
• Single center study
• Observational
• N = 387 TF TAVR treated with
dual Perclose vs. single
Perclose and adjunctive
Angioseal
• No differences in any
endpoint
• Alternative strategy of 1
Perclose and 1 Angioseal
appears feasible
Succefull Fully Percutaneous EVAR
Ambulatory Ptes
(Same Day Discharge)
Fully Percutaneous EVAR
CrossOver
Fully Percutaneous EVAR
MANTA VCD (Vascular Closure device)
Van Mieghem et al. JACC Interv 2017;10:613-9
closure unit
8-F puncture locator
introducer
sheath
Plug (bovine collagen pad)
Toggle (poly-lactic-co-glycolic acid)
T&T for BB closure
Percutaneous Plug-Based Arteriotomy Closure Device for Large-Bore Access
A Multicenter Prospective Study
Van Mieghem et al. JACC Interv 2017;10:613-9
50 ptes (79.5±8.3 years). PCI, Valvuloplasty, TAVR with catheters sized 12-F to 19-F
14-F MANTA in 16 (32%). 18-F MANTA in 34 (68%)
0
5
10
15
20
25
30
35
40
<1 min1-2 min 2-10min
>10 min
37
6 4 3
# o
f p
ati
ents
Time to Hemostasis: mean 2 min 23 sec
Private and Confidential Fully Absorbable Patch
PerQseal® – Next Generation large hole VCD
32
Dedicated calibrated introducer
0.014’ safety wire
Simple 3-step delivery and deployment
Immediate tamponade response
Designed for large arteriotomies
Fully synthetic, fully absorbable low profile implant
Simple over the wire delivery with safety wire in position
Full hemostasis control throughout delivery and deployment
No pre-closure
No metal, no sutures, no collagen
Percutaneous Access for TAVI
Prostar 10XL
Surgical Cutdown Should be Considered in Patients with:
• Calcifications of the puncture site (anterior wall)
• Previous trauma to the puncture site (EVAR, grafts)
• Very high puncture needed due to specific anatomy
• Other risk of bleeding (thrombocitopenia)
Small & Calcified Femoral and iliac arteries
TAVR Difficult Access: Direct Aortic
Samall & Calcified Femoral and iliac arteries
TAVR Difficult Access: Direct Aortic
Minimally Invasive TVAR by Transcaval Access.
TAVR (n) Minimalist
n=227 (%)
Conventional
n=74 (%)
p
All Death 9 (4) 1 (1.4) ns
MI 2 (0,9) - ns
Any Stroke 4 (1.8) - ns
Major 2 (0,9) - ns
Minor 2 (0,9) - ns
ParaValvular Leaks
Severe 3 (1,3) 2 (2.7) ns
Midldle-Moderate 25 (11) 17 (23) 0.01
PPM 78 (34,4) 25 (33.8) ns
Any Bleeding 15 (6,6) 5 (6.8) ns
Vascular Complications 6 (2.6) 1 (1.4) ns
Pseudoaneurysm 1 (0.5) - ns
Surgical Repair 2 (0,9) 1 (1.4) ns
Bleeding Bailaut stent 2 (0,9) - ns
Thrombosis (Fogarty) 1 (0.5) - ns
Hospital Stay 4.1±1.8 6.1±5.2 0.01
Minimally Invasive TVAR
ICyCC Experience. Mendiz O, et al. Unpublished
0
10
20
30
40
50
60
0-50 51-100 101-150 151-200 201-250 251-301
E. Conser. E. Min. Invas.
Minimally Invasive TVAR
ICyCC Experience. Mendiz O, et al. Unpublished
Big Bore for Venous Access: TPVR
• Underneath first, above vein, cross above, then above bite (don’t hit vein again!)
Proglide or Prostar
Or
“Figure 8” suture
Big Bore for Venous Access
Big Bore for Venous Access
Courtesy Dr Z Hijazi
Conclusions
• Percutaneous Big Bore Closure is a key issue to achieve Minimally Invasive Endovascular and Structural procedures such as: TAVR-EVAR-TEVAR-MitraClip-TMVR-TPVR & TTVR.
• Pte Selection & training are mandatory.
• Be always prepared to solve complications
• Surgical Buck-Up is mandatory.
Drowback: Operators’ radiation exposure!!!
Remember that:
“Minimally Invasive Femoral Access can be a highway for heavy traffic”
But… Be Careful, that something can go wrong!!
Thank You
for you
attention!!
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