sheathless use of the new portico™ transcatheter aortic valve
TRANSCRIPT
1 © R A D C L I F F E C A R D I O L O G Y 2 0 1 6
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.