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IntroductionThe Policlinico di Monza (Milan, Italy) is a leader in the endovascular

treatment of structural heart disease, accounting for more than

2500 procedures including transcatheter aortic valve implantation

(TAVI), atrial septal defects (ASD), patent foramen ovale (PFO) and

renal denervation.

The team has experience with various TAVI devices and has completed

more than 700 TAVI procedures. Most recently, the team incorporated

the innovative Portico™ transcatheter aortic valve system (St. Jude

Medical).

The Portico™ transcatheter aortic valve system was the first fully

resheathable, repositionable and retrievable TAVI device built on the

Trifecta™ valve platform. Depending on the size of the valve chosen,

the delivery system has a width of 18–19 F (6.0–6.4 mm) at its distal

end (8.5 cm), where the valve is placed, and a width of 13 F (4.3 mm)

on the proximal shaft.

Table 1

Product Proximal Outer

Diameter

Distal Outer

Diameter

18 F Portico™ Delivery System 4.3 mm 6.0 mm

19 F Portico™ Delivery System 4.3 mm 6.4 mm

The self-expanding stent can be fully resheathed, allowing for

repositioning both proximally and distally at the implant site. Thus,

the Portico valve can be fully recaptured and retrieved.* The flexible

delivery catheter enhances “trackability” in patients with tortuous or

highly calcified vessels and minimises issues at the access site.

The team’s initial experience with the Portico transcatheter aortic valve

system was in June 2015. A diabetic, 82-year-old woman presented

with angina and dyspnoea (NYHA III–IV). The patient had concomitant

chronic obstructive pulmonary disease (COPD), moderate pulmonary

disease, peripheral arteriopathy and renal failure (eGFR 35 ml/min).

The transthoracic echocardiography revealed a reduced EF (≈45  %),

an aortic valve (AV) mean gradient of 47.35 mmHg and a pulmonary

artery systolic pressure (PASP) of 50 mmHg (Figure 1). Normal coronary

arteries were found upon angiographic study.

The patient’s surgical risk was determined to be extreme: Logistic

EuroSCORE was 54.41 % and the EuroSCORE II was 11.74 % (STS Score

10.7 %). The patient was scheduled for a TAVI procedure.

CaseA computed tomography (CT) scan revealed severely calcified arteries

at the vascular access site. Both common femoral arteries were

stenotic and quite tortuous. Specifically, the right common femoral

artery had a mean diameter of Ø 3.5/3.0 mm and the left common

femoral artery had a mean diameter of Ø 4.5/5.5 mm (Figure 2).

Due to their small dimensions, none of the femoral arteries were

suitable for the procedure; the smallest sheath on the market has an

outer diameter of 6 mm (see Table 2).

Sheathless Use of the New Portico™ Transcatheter Aortic Valve System in Complex Vascular Access Cases

G Sorropago,1 C Auguadro,1 A Sorropago,1,2 M Finizio,1 F Scalise1

1. Interventional Cardiology Department, Policlinico di Monza, Monza, Italy; 2. Università degli Studi Milano Bicocca, Milano Italy

Keywords• Aortic stenosis

• Transcatheter aortic valve implantation

• Structural heart

• Resheathable

Published: September 2016 Citation: RadcliffeCardiology.com, September 2016

Figure 1

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Sheathless Use of the New Portico™ Transcatheter Aortic Valve Complex Vascular Access Cases

Calcium infiltration into the arterial walls increased the risk for

potential complications, including vascular dissection and peripheral

embolisation. Based on this assessment, it was determined to

use the Portico™ transcatheter aortic valve system without the

introducer sheath.

ProcedureThe TAVI procedure was performed under local anaesthesia and

vascular access was obtained at the right common femoral artery

via standard percutaneous access techniques. A 0.018 wire was

introduced through the right common femoral artery into the left

superficial femoral artery in order to protect it by using the cross-over

technique. The left common femoral artery was then punctured under

angiographic control. Sutures of Perclose ProGlide™ (Abbott Vascular)

were placed to simplify haemostasis following the procedure.

A 12 F introducer sheath and 20 mm balloon (Osypka VACS III™,

Osypka AG) were used to dilate the native aortic valve and facilitate

placement of the Portico valve. The 12 F sheath was then removed

and the delivery system of the Portico™ valve was introduced into the

artery. The delivery system was introduced without a sheath, allowing

for easy access from the thoraco-abdominal aorta to the aortic arch

(see Figure 3).

Figure 2 Figure 3

Table 2

Product Inner

Diameter

Outer

Diameter

SJM™ Ultimum™ 18 F introducer 18 F 6.8 mm (20.4 F)

SJM™ Ultimum 19 F introducer with

Portico™ valve

19 F 7.3 mm (21.9 F)

MDT EnVeo™ R Inline™ integrated sheath 14 F 6.0 mm (18 F)

BSC Lotus™ introducer large (25/27 mm

valves)

21.9 F 7.9 mm (23.7 F)

BSC Lotus™ introducer small (23 mm

valves)

20.1 F 7.5 mm (22.5 F)

EDW eSheath™ 14 F 14 F 7.6 mm (22.8 F)

introducer sheath (unexpanded) expanded

EDW eSheath™ 16 F 16 F 8.2 mm (24.3 F)

introducer sheath (unexpanded) expanded

Cook™ Check-Flo™ 18 F introducer 18 F 7.3 mm

Cook Check-Flo™ 20 F introducer 20 F 7.7 mm

Terumo™ SoloPath™ 18 F system 18.2 F 7 mm (21 F)

expanded

Terumo SoloPath™ 19 F system 19.2 F 7.3 mm (22 F)

expanded

Terumo SoloPath™ Recollapsible 19 F

system

19 F 7.7 mm

Gore™ Dry Seal 20 F sheath 20 F 7.5 mm

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Sheathless Use of the New Portico™ Transcatheter Aortic Valve Complex Vascular Access Cases

Due to the small diameter of the delivery system (4.3 mm with the

exception of a 8.5 cm long segment at its distal extremity), the device

exhibited good trackability and the risk of damaging the arteries was

reduced during the first passage of the device and during the later

maneuvers. Note that since this proximal part of the Portico™ delivery

system is smaller than the distal part that houses the valve, slight

manual compression was utilised during the procedure to maintain

haemostasis at the access site.

First, the mobility of the Portico™ valve was tested and proved to

be extremely manageable. The prosthesis was then released to 90 %

of its total capability (see Figure 4). If an inappropriate position had

been found during the angiographic test, the valve would be partially

or fully resheathed.

The Portico valve was repositioned, further aligned and partially released

and assessed (see Figure 5). As the test showed a very satisfying

partial positioning, the Portico valve was completely released with

optimal final angiographic result. It is good practice for any sheathless

TAVI procedure to leave the delivery system in the descending aorta

after valve deployment until final haemodynamic assessment is

complete, to ensure haemostasis at the access site. Haemostasis was

easily obtained with the use of one Perclose ProGlide™ closure system

combined with cyanoacrylate glue (see Figure 6).

OutcomesAt six-month follow-up, the patient no longer had angina and her

dyspnea was reduced noticeably (NYHA II). Echocardiographic imaging

showed a perfectly working prosthesis without paravalvular leaks.

The AV mean gradient decreased to 7.82 mmHg and the left ventricle

function improved (EF 53 %).

ConclusionsThe cited case demonstrates sheathless access is feasible with the

Portico™ system. In this case the Portico™ valve system has the benefit

of manageability and trackability, while reducing vascular compromise.

Moreover, the sheathless potential of the Portico valve improves access

site management and helps achieve faster haemostasis. n

Figure 4 Figure 6

Figure 5

Rx Only

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.Portico, Trifecta and Ultimum are trademarks of St. Jude Medical, Inc. EnVeo and Inline are trademarks of Medtronic, Inc. Lotus is a trademark of Boston Scientific Corporation or its affiliates. eSheath is a trademark of Edwards Lifesciences. Check-Flo is a trademark of Cook Medical. SoloPath is a trademark of Terumo Interventional Systems. Perclose ProGlide is a trademark of Abbott Laboratories. VACs III is a trademark of Osypka AG.