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!!