Fluid dynamic characterization of a polymeric heart valve prototype (Poli-Valve) tested under continuous and pulsatile flow conditions

IJAO

_{ISSN 0391-3988 ORIGINAL ARTICLE}

as an a art a s t t r na a -r an f-r fr anti ag ant t ra (1) As s gg st

t t rat r (2 3) tiss a s a a arg r ntra r t an an a a s an r s t n t r -ti n f t r n s arg r r a s r s na n ti ns an a s a r as n trans a -ar r ss r r s A t s nts an a t r as tra a r s t t s r a s f arti a art a s n t r s n r s ar fr fr ati ns f r r s g t r nt str ss s at t a ti a-ti n n ar tis t r nts ar s ng fr t f r ati n an t r s s nt ta nt On t t r an r st ti art a s s r fr str t ra a -ar t r rati n a t a ati n an r t ar ng an s rt t r ra t (1) r art a s ( s) r n r r t n t ra t f t s t t ati -t f -t s rst - a t r st ti art a s r ant n t 1960s t a t g s nt ti art a s t a ta s rt-t r an a r rti s OI: 10 5301 a 5000 52

Fluid dynamic characterization of a polymeric heart

valve prototype (Poli-Valve) tested under continuous

and pulsatile flow conditions

Francesco De Gaetano1_{, Marta Serrani}2_{, Paola Bagnoli}1_{, Jacob Brubert}2_{, Joanna Stasiak}2_{, Geoff D. Moggridge}2_,

Maria Laura Costantino1

1 _{art nt f str at r a s an a ng n r ng Na a t n an an - Ita} 2 _{art nt f a ng n r ng an t n g n rs t f a r g a r g -}

Introduction

N a a s 2 a r t s f anta arti a art a s ar a a a : an a an r st ti art a s A t g an a art a s ( s) a n t st n ant s n t ast ars t an s t t r r a ng t r ra t r st ti tis-s art a tis-s ( s) ar rr nt ant as fr nt ABStrACt Purpose: On an a an g a art a r st s s ar rr nt r a a a a f r r s ng r ra t t r r anti ag ant t ra ; t a r s a r na a r t n t a a at ra t N r art a s ( s) t ntia n t na r rti s f g a a s t t ra t f an a a s s r r s nts a r na a -ati n f 2 gr s f n s ra-ann ar tr a t r st ti art a s a fr st r n

rs (S ): - a s

Methods: 2 t s f - a s a f S an r ng n st r n fra ti n nt nt r t st n r ntin s an sati n ti ns as r s r ISO 58 0 Stan ar A s at r s gn a a t a r t t s t t st at r nt rat s an fr n s r ss r an r r r ; r ss r r s ti r ar a ( OA) an r g rg tant r t t ass ss t

-a r f t -a

results: t t s f - a s t t n r r nts n t r s f r g rg tati n an OA as s t ISO 58 0 Stan ar s ts r ar t 5 an a art a s ( s) an 5 tiss art a s ( s) rr nt a a a n t ar t

Conclusions: as n t s r s ts s as n st r n rs as ar a s an ns -r a -r s ng a t rnati f r art a r a nt n t n ar f t r

Keywords: art a r st s s r art a s s at r sati St r n

-rs

Accepted: r 1 2015 Published online: r 1 2015 Corresponding author:

Francesco De Gaetano

Laboratory of Biological Structure Mechanics Department of Chemistry

Materials and Chemical Engineering Giulio Natta Politecnico di Milano

Piazza Leonardo da Vinci 32 20133 Milan, Italy

t r s s ti t t r ti an ati gra ati n an s s nt an a fa r a t t r s ss-f s ( 5)

In r nt ars a an s n r s n a g n r s t an rtant n ass f arti a art a r

-nant a f r t an - as at r a s s g ati t an sta t (6-9) a gra s g nt r t an ( ) as n s ssf a n ar s ar as ar s a s ar r-r nt ti s n r a a a a ass st s (10 11) t n r r st s s a r n ng-t r ra t f r n a antati n s far t t r ti gra ati n f t r t an a n n r in vivo n -ti ns (12) r r nt t nt n r at r a t n g s a n nan s t r ati n as ra s nt r st aga n n f r art a s an t a (13) r s nan - r t an s as nn a-ti sta at r a s a a f r ng t - n n

gra ati n ss f r stan ar t a f n ti n-a n-ati n f ts ati r s a s t ( ar nat - r a)

s g nt n t ra g r s s s -an s n-an arti s (1 15) An a t rnati n f r s ta f r t s gn f s nt ti art a r st s s s r nan -s t -s str t r f rs an ta r t a an a an a a r rti s starting fr t n f 2 r r rs r rti s f t na r t t n t s f t n tia at r a s (16) A ng t ss n s n ast rs as n st r n r a ng r s as a a a rs f r t nstr ti n f art a r st s s t t r g ati t r s ng an a r r-ti s an ati n r s stan (1 -20) In r a a a a rs s as (St r n -Is t n -St r n ) (SI S; Inn a rs) s s r r -a st-a t (21 22) -an g fatig r s ns (23 2 ) n an ng-t r ra t t r g n t an na a r ang t a (25) r n-f r nt t n t r t a at ( ) fa r nt (st r n - - s t n - -st r n ) (SI S) an t s rfa f t s r st ti a s t a -r st s ati n ( ) at s SI S a s fa n an a t sting a s f at r a a ag an a ati n a t s ra a s t r rti s f SI S a t r n r r t r t str t ra nt gr t r r f r ng-t r s in vivo t s r s Stas a t a (26) s t r an a tr at nts t ang t r str t r f st r n rs an ns nt t r an a a r In arti ar nstrat t at a n r a r -g f t r a ns a t rn fr s tr t r nt r ss n ng n ann s (20) s an s tr r r g f ti t str t r -f n ti n -f an s tr ag n n t nati a r ng t rf r an f t (2 ) a f t s r s t ara t r t r na a r f n r t t s ( - a ) fa r at a r ss n ng n r ntin s an sati n -ti ns n r r t st t a a f t - a t

s as an a t rnati t an a an tiss art a s rr nt n t ar t Methods A t ta f 16 n r t t s ( - a s) r an-fa t r r ss n ng t n fr t f-f r nt r a a a a st r n rs (S ) ta n fr rat n rf r an rs gr s f a s r n stigat a n r s ng 8 a s: r A: a s an fa t r fr (st r n b s -r n ta n -b-st r n ) rs t 19

r ntag ass ( t) st r n fra t n

r : a s an fa t r fr (st r n b s -r n -b-st -r n ) rs t 30 t -st r n fra t n t at r a s ar n ar rs t narr -ar g t str ti n f a t 180 g -1 _{an 130 g} -1 _{f r gr s A an r s ti r nt st} -r n f-ra ti n t at a-ra t -r s t 2 at -r a s s -r s n-s f r a r nt sti n ss f t s rs sti n ss s r t r at t t r an a str ngt as r rt n (19) nts ( g 1A) r an fa t r n a -n s ar r s n ( a r g a t r s gn) as n a 3- ns na g tr r ating t nat ra n g ra-ti n f tr a t art a s (28) - a r t t s r ta n t r ss ng at 150 s (a r at 0 5 3_{) f t r n tia at at t} -ss ra f a f t 3 a ts f t a - a g tr r an ns ns ar r rt n g r s 1 an - a s ng ng t t r A an r r t st in vitro n r ntin s an sati t a at r ss r r s an r g rg tati n n t n ti ns as r n ISO 58 0 Stan ar (29) ntin s an sati t sts r rf r s ng sti at r at r t rat r (25 ) Continuous tests r nta t st n s t a at - a r ss r r s n ntin s n ti ns s s n n g r 2A s t ns st f a r s r r a ntr f ga ( IO- I S - 550 IO ONSO ; tr n ) an a a s ng n t ( ) s gn a r ng t t g -n s f t ISO 58 0 Sta-n ar a s r s a t O-r ngs n t t a an a ag a s r t st at rat s rang ng fr 0 t 10 n t an n r nta st f 0 5 n rans a -ar r ss r r as as r 3 ti s f r a a r ss r trans rs (1 0 r ss r s ns rs n ) t r f t r ata t f t t sts r nta s t f r t r g rg tati n t st -r s a a (t sa s r ng t ntin s t sts); a r s r r s ti n str a t t a at t sa g ti t r a nstant r ss r r a an a r s r r a nstr a fr t a at r-nt g ts t ar t a r ss r a ting n t a

r ng t sting t g t f t r s r r as ang t r a a r ss r rang ng t n 28 t 128 g (5 g st s) t n 2 ns ti as r nts a r ss r as s t t r g t a t a t r

-r ts n tia n g -rati n r g rg tati n rat at a a r ss r as as r s ng a trans t-ti tra-s n t r ( 110 s r s rans n S st s) Pulsatile tests as n a r s r (30) a n s at r as s gn an t t rf r sati t sts ( g 2 ) It ns sts f t f ng nts: a t-r ng s st a ntr ar a r an a rti a s ng a s st an s at r an a tra a s ng tr ng s st an t s st -an s at r a n r s s r n ta (30) ng s st as r n an tr n n-tr r a ng t s ng f r nt rat a f r s an r nt fr n s In t s r t s st rat as r at t S ans n an ar a f r (31) a a r an rat a f r (32) as s t r r t ast rat ntr -ar a r a s t s ati n f t s g a an at g a str (S ) ntr ar a -r an t ng s st ar a t n s n ran (t n ss 0 3 ) s a t st n an s at an t sti at r t r nt a -ag t t an a s st t t r nts f t s at r an t r nt s ( g r s s ating t r g a r rti s) f r r a rti an t tra a s ng ar t sa s f r t ntin s t st an ar nn t t stra g t t s t t s st an s at r an t t ntr ar nt r s ti rt r r t s s t a s t r t s a s r ati n f t a s at r nt ti st s f t A r ng t t NI N ISO 58 0 Stan ar t n s at r r r s t s g a r ss r an a f r s ( g 3) ( art r a a s st r ss r rang ng fr 100 t 130 g art r a ast r ss r fr 65 t 85 g r ntia r ss r a r ss s a rti a a t 95 g) - a s r t st at r nt rat s an a r ss r s as r r t NI N ISO 58 0 Stan ar Fig. 1 - (A) A n (B) s t an (C) t r f - a ns ns ar : a t 10 ∼10 9 ; t t 21 ; nt 21 ; t 28 ; tiss ann s a t r ( A ) 21 ; t n ss a t 0 36∼0 2

Fig. 2 - O t n f t t st n s: (A) r nta s t f r ntin s t sts (B) r nta s t- f r t sati t sts ati ns f str a an nstr a r ss r an rat r s ar s n n t s t ; t s r ati n nt fr t r s r ta n s n at t s

rans a ar r ss r r as as r at a nstant fr -n ( 0 ) an ar a rat (2 3 5 5 an n) g rg tati n as t r n t sting a a at a an rat f 5 n at 3 r nt fr n s ( 5 0 120 ) At a fr n 3 a r ss r s r t st (80 120 160 g) S tan s as r nts r r r s ng trans t-ti tras n -t r an r ss r -trans rs at 35 str a an 105 nstr a fr t a rti a rans a ar r ss r r r g rg tati n ( ) r g rg tant fra ti n ( ) an s st r ss r r n ( S ) an ti r ar a ( OA) r a at f r a a ati n 1 as s t a at S

∑

= =∆ MSPD pi n i 1 n 1 r _i s t r ss r r n a r ss t a n g an n s t n r f sa s r ng t s st as ati n 2 fr ISO 58 0 (29) as s t a at OA = ρ ∆ EOA Q 51.6. p RMS ₂ r s t an r ss r r n n g s t ns t f t t st n gra s r nti tr an Q _S s t r t an s ar f f r ar n tr s r s n g n ati n 3

∫

= − Q Q(t) dt t t RMS 2 t t 2 1 1 2 3 r (t) s t nstantan s at ti t t₁ an t₂ ar ti at start an n f t f r ar r s ti g rg tati n s g n ati n

∫

= RG Q(t) dt t t 3 4 r t₃ an t ar ti at start an n f t a ar r s ti s a at ati n 5 = RF% RG SV.100 5 Statistical analysis a a as n t st f r at ast 15 ns ti s at a t st n ti n S SS Statisti s rs n 21 (I ) as s t rf r statisti a t sts A ata ar r rt as an stan ar ati n (S ) In n nt-sa s t-t st as s t t r n statisti a s gn ant r n s t n t gr s S gn an f r t t sts as s n at 0 01 Fig. 3 - r ss r an tra ngs a r r ng a sati t st fra (A) r rts t s st r s-s r gra nt r ti a t a a f r A an t an s s-t r ss r r n ( S 8 g) t r s s t a r f t 2 gr s f a s (solid line r A an dashed line r ) at r nt nstants r ng ti : (B) ar ast (C) n

results

Continuous flow test

r A s a statisti a r ( 3 2 - ) an trans a ar r ss r r (8 36 1 33 g) t an r (15 26 1 8 g) at t a rat (10 n) ( g A) A s t an r g rg tat n s a r A as r (1 5 3 19 n) t an r (26 26 n) ( g ) t t ff r n s stat st a ns g-n f ag-nt ( 0 0 ) s a ff r n n r g rg tat n t n t 2 gr s a as r t t ff r nt a ag ar a f r r ng t a s ng as ( g )

Pulsatile flow test

A t t st - a s t n rf r-an r r nts s t t ISO 58 0 Stan ar ( g 5): a t 16 s s OA 1 2 _{an a r g rg tant 10} f t str (S 1 ) n rf r-an r r nts rr s n t t f ng sati -n ti -ns: art rat 0 s n s at ar a t t 5 0 n S 1 an a rti r ss r 100 g an s st rati n 35 r A s statisti a g r OA (1 5 0 21 2₎ t an r (1 21 0 12 2_{) ( 2 29 - )} an r g rg tati n as ara t n t 2 gr s ( 13 1 33 f r A s 6 60 0 9 f r ) ( 0 05) Fig. 4 - s ts f ntin s t st: (A) ar s n f trans a ar r ss r r s t n t 2 gr s f a s ( ata ar r rt as an a ng 8 a s S ) (B) t r s f 2 - a s (t a fr r A; a fr r ) at 2 r nt rat s (0 n n t an 10 n n t r g t) (C) ar s n f r g rg tati n -t n t 2 gr s ( ata ar r rt as an a ng 8 a s S ) (D) t r s f 2 - a s (t a fr r A; a fr r ) r ng stati r g rg tati n t sts at 2 r nt a r ss r s (28 g n t an 128 g n t r g t)

Fig. 5 - OA (A) an r g rg tati n (B) ( str ) f r t 2 gr s f a s r ng sati t sts n ti ns: rat 0 n ar a t t 5 0 n an a rti r ss r 100 g an s s-t rati n 35 r nta n s n at t ISO 58 0 s ati ns f r t sa sati n ti n

t sts s t at t S r r n r A as statisti a r (12 20 1 1 g) t an n r (1 09 3 39 g) ( 0 0019) A s t a trans a ar r ss r r s r sta-tisti a r nt ( 3 3 -05) t n r A an r r A s a a r ss r r a t 30 09 g n r t as 3 98 52 g Discussion St a stat an sati r na t sts r r-f r t a r nf r ati n an n at rs n t an a a r f - a s an fa t r fr rs a ng r nt st r n nt nt r s ts fr ntin s an sati t sts nstrat t at t trans a ar r ss r r s r at t t sti n ss f t r n r as s t st r n ass r nt-ag n t at r a ( gs A an 5A)

r n s t n r A an r f r t OA an an trans a ar r ss r r s ar statisti a s g-n ag-nt as nstrat n n nt-sa t-t st

s r n s an a n t g r an a str ngt f t r t at nstit t s t a s ng-ng t r f ar t t at r a nstit ting a s ng ng t r A As a a r f fa t ng nstant a t t r n ti ns a g r at r a sti n ss s r s ns f r a s a r a t f r ati n r ng t s st as an ns nt f r a r a n ng s r s t an as r t t r a t f r-ati n ta n r ng t s st as n t a s -ng -ng t r ; n fa t t g r st r n g t fra ti n ara t r ng t r n t s a s n s sti r a t a r t s r s ting n a r a n ng - a s s g n ng an s ng rf r an -s ( g 3) ng t a r f nat ra art a s r g rg tati n n t ntin s t sts s r n r A t an n r ; n rs f r t sati t sts t r g r-g tati n s r n r t an n r A r n t t sts t r n s statisti a ns gn ant t n t 2 gr s A t 16 - a r t t s t t n r -r nts s n t ISO 58 0 Stan ar t n t r s f r g rg tati n an OA ( g 5) nstrating t r -ti n ss r t r nta t sts rf r n t s Fig. 6 - ar s n f t - a r na rf r an s ( OA an g rg tati n r g t) t t rat r ata (33 3 ) f r tiss an an a art a s at t f ng sati n ti n: art rat 0 n s at ar a t t 5 0 n an a r-ti r ss r 100 g an s st rati n 35 st r t at t a s ng ng t r A s r a r n t r s f OA an an r ss r r s r a t t r sti n ss f t a ts a s a r n ng r rf r an s s a t a s ng-ng t r A s gg st t at rs a ng r t an a 30 st r n fra ti n s s n f r - a an fa t r ng na a r s a t 2 gr s f - a s t st n t s st r ar ( g 6) t t rat r ata f r r a art a r st s s a -ng t sa tiss ann s a t r ( A ) as - a s: 5

an a (33) an 5 g a (3 ) t OA an r g r-g tati n f an a an tiss art a r st s s ar

ara t t ata ta n f r - a s an -a -art -a s s t g st an t ta r g rg tant (rang ng fr 6 08 1 23 t 10 8 1 53 ) an OA (fr 1 3 0 11 2 _{t 1 90 0 10} 2_{) tiss a s} s t st rf r an s n t r s f an r g rg tati n (fr 3 86 0 85 t 1 96 1 26 ) r s ts f t s -ar s n s t at t r na a r f - a s a a t a a a t rnati t t a r st s s rr nt a a a n t ar t ( g 6) ra t f t - a n t n n s n t an a r rti s f t a at r a s t a s -n s -n t a-n fa t r -ng t n an n t str ss str ti n n t at r a r t r na as-s as-sas-s nt r s nt n t s a r t g t r t t s ti r s ts f t ra t t sts a a f r r st ti art a as n st r n r as s - a an a ra ti a t rnati t t an a an r a s rr nt s Disclosures

nan a s rt: s r as f n t r tis art n-ati n N r ns grant N 11 29059 n t f nt r st: N n f t a t rs as nan a nt r st r at t t s st t s s references 1 an as ganat an A nt A an s n r art a s s ar Int J at r s ng 2011;1(1):1-1

2 S a SS r s r J n ati s f s nt ti a t art a s r ng a rat t sting J art a s 2003;12(1):110-119

3 as ar rr J S n A ganat an A -na ass ss nt f t r r art a s s ng ar-ti ag tr Ann ng 2006;3 (6):936-952 an ar atg an A rr s a a S -fa an A r art a s: n at r a s rg ng s r n s t n 2009;2 (6):359-36 5 a r n J an n t r st ti art a s: at r ng f r t f at r a s 2008;29( ):385- 06 6 a a rna a s r A n S at J In vitro f n ti n an ra t ass ss nt f a n r t an art a r st s s Artif Organs 1996;20(9):101 -1025.

rna a a a ns n at J r

-t an ar-t a s: fa-tig fa r a ati n an r -t an s-tr -t r J at r s 199 ;3 (3):3 1-3 9 8 rna a Stra I at J an a an r

-g a st f sta r t an art a a ts -ant fr s J at r s 2002;61(1):138-1 5 9 a r t S a st n r anns t a N

r art a r st s s f r t tra an a rti s -ti ns art S rg r 200 ; (5): 525- 532

10 Sa JS a r t S N an a r

a r st s s t s a s gn f r a rti an tra -s ti n: a f t r ti n f r atr ati nts ASAIO J 2006; 52(5):5 5-580

11 Ara a A sa S t t a atr r g t art trans antati n: a ati n f t r n art s an rat ntr ar ass st s J art ng rans ant 2006;25(1):16-21

12 Sa a ns J O a a t n S fa an A r -an a -ana s s f a ant ( ar nat r a) r -t an a r s r t r ti ati r ati an g a s ti ns at r a s 2002;23(10):2231-22 0 13 an A rr s r s ng an ar n r S fa an A A n nan s t r f r -nt f s -nt ti art a a ts A ta at r 2009;5( ):2 09-2 1 1 an ar atg an A rr s a a S -fa an A r art a s: n at r a s rg ng s r n s t n 2009;2 (6):359-36 15 an ar an A rr s a s ar s r A S fa an A anti- a ati n t ntia f a s s s -an n-an s t r n r in vitro n ti ns: t n-tia at r a f r s nt ti a t art a A ta at r 2010;6(11): 2 9- 260

16 n r as A a a J a A r n r S a r n ar f r ati n f a n ar-s ng - r sta

tr r t a n r a r g 1 S n r -tr n SA S a r s 2000;33(25):9395-9 06 1 a rn S r J ng St ns f r S an J st n In vitro a ati n f a n na a -ti tr a t r r st ti art a J ng 2013;135(2):021021 18 a rn st n S rst r nt an a ati n f a n arti a at t r- ra r s-t s-ti ars-t a an t f r in vitro t sting Int J Artif Organs 2009;32(5):262-2 1 19 Stas a J Na r S ggr g an a str ngt f s -t r rs s f r a ar ng a a a-ti ns at r ng 201 ;2 (1):563-569 20 Stas a J ggr g a ra A an A stantin ng n r ng r ntati n n rs f r a a-ti n t r st a-ti art a s n ti na at r a rs 2010;3( ):2 9-252 21 ra s a N s n S rst r A s - st r n - s t n - st -r n (SI S) t-r r f r n an ati t

an t ntia s n arti a art a s J at r A 2009;23( ):36 -3 9 22 n s n J arr JJ S rst r ar J nn J a a ati ns f (st r n - - s t -n - -st r n ) ( SI S ) at r a s 2008;29( ): 8- 60 23 ra r ans s as J A tst t ati t an fatig r rti s f st r n - s t n - -st r n an rg ng t r asti ast r at r a a r s 2006; (3):8 -850 2 a r S Ag rr A as an n S rst r A n r f r t ntia s n a tr a t art a J at r s A at r 2006; 9 (2):325-33 25 ang r n AJ an at n S

r-st r In-vivo ass ss nt f a n r (SI S) tr a t art a J art a s 2010;19( ): 99-505 26 Stas a J S r s A ast a I ggr g t f Str t ng n t Str t r f n r- an S r -r ng St -r n Is -r n St -r n rs a r -s 2009; 2(1 ):5256-5265 2 Stas a J r rt J S rran t a A - ns r r str -t r n s n ti n ng f n r a rs S a r 201 ;10(32):60 -6086 28 a tan agn a ra A t a A n tr - a t r art a r st s s J 2015;15(2):15 0009 29 ar as ar ants ar a a r st s s ANSI AA I ISO 58 0: 2005;2005 30 an ar n s ara r A n sati tr t r a s f r t in vitro st f t ar-as ar s st Artif Organs 2009;33(12):10 8-1062 31 S ans n ar A s ar as ar s st s -at r: s gn an rf r an J ng 19 ;1(2):135-1 5 32 a r N an s f Nat ra ar a a s In: a r ss s Art r a S st r n -rg: S r ng r 19 8; 269-2

33 a r asar r sa S a a rti ann -s: t r na rf r an s f 5 r a a a -a a t an a a s J ra ar as S rg 200 ;128(3): 5 - 62 3 r sa ar a S a a rti ann s: t r na rf r an s f 5 r a a a a tiss a s J ra ar as S rg 2006;131(5):1058-106 2