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First implantation of the Acurate neo2 prosthesis in a patient with aortic stenosis in Poland

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C L I N I C A L V I G N E T T E First Acurate neo2 implantation in Poland 207 covered with a sealing skirt. The delivery system is designed for flexible and intuitive position‑

ing (Figure 1F). The position sheath is extended and the insertion aid is shortened. The 14F iSLEEVE Expandable Introducer has low profile which sim‑

plifies access and provides a smooth insertion even for small and complex arteries (≥5.5 mm).

A radiopaque positioning marker determines clear visual positioning reference, crucial for a successful implantation. Enhanced tip design improves guidewire transition and tracking.

The major advantage of this valve is a new Active PVseal Technology designed to mini‑

mize PVL, especially in irregular and calcified valves. The prosthesis has inner and outer peri‑

cardial skirts and the extended sealing skirt covers the full waist of the stent. The rate of PVL was evaluated in 120 patients in the Acu‑

rate neo2 CE ‑Mark Study which was presented during the PCR London Valves in 20182 (30‑day outcome) and at the Transcatheter Valve Thera‑

pies (TVT) Conference in 20193 (1‑year outcome).

The PVL rates were lower than reported for the previous Acurate neo prosthesis, with 97% of patients with none, trivial, or mild and only 3%

with moderate PVL at 30 days, and 97.5% and 2.5% with none to mild and moderate PVL, re‑

spectively, in 1‑year follow‑up.

Since coronary angiography may be necessary in some patients after TAVI,4,5 large open cells fa‑

cilitate coronary access even in low coronary os‑

tia. Several features of the prosthesis diminish the risk of pacemaker implantation (minimal pro‑

trusion into the left ventricular outflow tract and top ‑down deployment). Top ‑down deployment differs from the deployment of other prostheses.

The prosthesis is released starting with the upper A 78‑year ‑old woman with a history of myo‑

cardial infarction, arterial hypertension, atri‑

al fibrillation, pulmonary embolism, and os‑

teoarthritis, who underwent previous percuta‑

neous coronary interventions, was admitted to our hospital with severe heart failure. Echocar‑

diography revealed severe aortic stenosis (mean and maximum gradient, 45 and 75 mm Hg, re‑

spectively), mild aortic regurgitation, and nor‑

mal ejection fraction. After careful evaluation of the patient’s medical history, imaging results, and perioperative risk (logistic EuroSCORE, 14.9;

EuroSCORE II, 3%), the Heart Team decided to refer her for transcatheter aortic valve implan‑

tation (TAVI). The procedure was performed on October 10, 2020 in the hybrid room, under local anaesthesia with puncture of femoral ar‑

teries and Proglide preclosure technique. Af‑

ter valve predilatation with the Osypka VACS III 24 mm × 400 mm balloon (Osypka, Rhein‑

felden, Germany), the Acurate neo2 size L aor‑

tic valve (Boston Scientific, Marlborough, Mas‑

sachusetts, United States) was successfully im‑

planted (Figure 1A–1D). No postdilatation was re‑

quired. After the procedure, no paravalvular leak (PVL) was present and the peak transval‑

vular gradient decreased to 12 mm Hg.

Acurate neo2 (Figure 1e) is a new generation TAVI system designed to treat patients with aortic ste‑

nosis. Compared with the previous version,1 both the prosthesis and the delivery system have sev‑

eral innovative features which simplify the pro‑

cedure and should optimize clinical outcome.

The prosthesis is currently available in 3 sizes: S (23 mm), M (25 mm), and L (27 mm). Three por‑

cine pericardial leaflets with the BioFix antical‑

cification process are fixed in the nitinol stent

Correspondence to:

Anna Olasińska­

­Wiśniewska, MD, PhD,  Department of Cardiac  Surgery and Transplantology,  Poznań university of Medical  Sciences, ul. Długa 1/2,  61­848 Poznań, Poland,  phone: +48 61 854 92 10, email: 

annaolasinska@ump.edu.pl Received: November 9, 2020.

Revision accepted:

January 10, 2021.

Published online:

January 18, 2021.

Kardiol Pol. 2021; 79 (2): 207­208 doi:10.33963/KP.15757 Copyright by the Author(s), 2021

C L I N I C A L V I G N E T T E

First implantation of the Acurate neo2 prosthesis in a patient with aortic stenosis in Poland

Anna Olasińska ‑Wiśniewska1, Marcin Misterski1, Aleksander Araszkiewicz2, Sebastian Stefaniak1, Anna Komosa2, Marek Jemielity1, Maciej Lesiak2,Marek Grygier2

1  Department of Cardiac Surgery and Transplantology, Poznań university of Medical Sciences, Poznań, Poland 2  1st Department of Cardiology, Poznań university of Medical Sciences, Poznań, Poland

(2)

KARDIOLOGIA POLSKA 2021; 79 (2) 208

2  Möllmann H. Transcatheter aortic valve implantation for severe aortic valve  stenosis with the ACurATe neo2 valve system: 30­day safety and performance  outcomes. Paper presented at: PCr London Valves 2018; Sep 10, 2018; London,  united Kingdom.

3  Möllmann H. Transcatheter aortic valve replacement with the ACurATe neo2  valve system: 1­year clinical and hemodynamic outcomes. Paper presented at: TVT  Chicago 2019; Jun 13, 2019; Chicago, united States.

4  Parma r, Zembala MO, Dąbrowski M, et al. Transcatheter aortic valve implan­

tation. expert Consensus of the Association of Cardiovascular interventions of the  Polish Cardiac Society and the Polish Society of Cardio­Thoracic Surgeons, ap­

proved by the Board of the Polish Cardiac Society and National Consultants in Car­

diology and Cardiac Surgery. Kardiol Pol. 2017; 75: 937­964.

5  Tyczyński P, Chmielak Z, Dąbrowski M, et al. Modified chimney / snorkel stent­

ing of the left main coronary artery after transcatheter aortic valve implantation. 

Kardiol Pol. 2020; 78: 792­793.

crown anchoring to the native valve leaflets, then the stabilization arches are deployed, which pro‑

vide axial self ‑alignment within the native an‑

nulus, and finally, the lower crown is opened in the left ventricular outflow tract. Rapid pacing during deployment is not required. The prosthesis may be postdilated if necessary. Main limitation of the current version of the prosthesis is the lack of possibility to use it in bicuspid valves and in valves with parameters larger than 27 mm for the aortic annulus diameter and 85 mm for the perimeter.

Article informAtion

conflict of interest  Mg received proctoring honoraria and research  grants, and is an Advisory Board Member for Boston Scientific. Other authors de­

clare no conflict of interest.

open Access  This is an Open Access article distributed under the terms  of  the  Creative  Commons  Attribution ­NonCommercial ­NoDerivatives  4.0  in­

ternational License (CC BY ­NC ­ND 4.0), allowing third parties to download ar­

ticles and share them with others, provided the original work is properly cited,  not changed in any way, distributed under the same license, and used for non­

commercial purposes only. For commercial use, please contact the journal of­

fice at kardiologiapolska@ptkardio.pl.

How to cite  Olasińska ­Wiśniewska A, Misterski M, Araszkiewicz A, et al. First  implantation of the Acurate neo2 prosthesis in a patient with aortic stenosis in Po­

land. Kardiol Pol. 2021; 79: 207­208. doi:10.33963/KP.15757

references

1  Möllmann  H,  Hengstenberg  C,  Hilker  M,  et  al.  real ­world  experience  us­

ing the ACurATe neo prosthesis: 30­day outcomes of 1,000 patients enrolled in  the SAVi TF registry. eurointervention. 2018; 13: e1764­e1770.

Stabilization arches

Upper crown Lower crown

A

D

B

E

C

f

figure 1 – The Acurate neo2 prosthesis and implantation stages; A – valve predilatation with the Osypka 24 mm × 400 mm balloon; B – Acurate neo2 after opening of the upper crown: confirmation of the proper position of the prosthesis; C – Acurate neo2 with fully opened stabilisation arches; D – Acurate neo2 after implantation: final angiogram; E – Acurate neo2 prosthesis; f – delivery system. Images E, f provided by courtesy of Boston Scientific. Copyright 2020 Boston Scientific Corporation or its affiliates. All rights reserved.

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