transcatheter aortic valve implantation for severe regurgitation in native and degenerated...

Original Studies

Transcatheter Aortic Valve Implantation for SevereRegurgitation in Native and Degenerated Bioprosthetic

Aortic Valves

Kunal Sarkar,1 MD, FACC, Gennaro Sardella,2 MD, PhD, Francesco Romeo,3 MD, PhD, MauroDe Benedictis,4 MD, Giandomenico Tarsia,5 MD, Alessandro Iadanza,6 MD, Samin. K.

Sharma,7 MD, FACC, Marco Barbanti,1 MD, Corrado Tamburino,1,8 MD, PhD, FESC, FSCAI, andGian Paolo, Ussia,1,8* MD, FSCAI

Objectives: We evaluated transcatheter aortic valve Implantation (TAVI) in high-riskpatients with severe aortic regurgitation (AR) in native or degenerated bioprostheticvalves. Background: TAVI has emerged as a viable treatment modality for severe aorticstenosis in inoperable or high-risk patients. The use of TAVI for treatment of severe ARhas remained largely unexplored. Methods: Eight patients (age 79.6 years 6 5.75 years)with severe AR underwent TAVI at six tertiary hospitals between April 2010 and May2011. All patients were considered to be at prohibitive risk for surgical aortic valvereplacement (SAVR).TAVI with the nitinol based Core Valve bioprosthesis (CRS) (Med-tronic) was performed in all patients. Results: Transfemoral access was used in allcases. Procedural success was obtained in all cases without any intraprocedural com-plications. There was no in hospital or 30-day mortality. There were no cases of atrio-ventricular blocks requiring permanent pacemaker implantation. At a mean follow up of15.5 6 15 months; all patients had improvement in New York Heart Association func-tional class. Follow up echocardiography revealed improved or stable left ventricularejection fraction and optimal device function in all cases. Conclusions: TAVI with theCRS bioprosthesis is feasible and effective in appropriately selected cases of severeaortic regurgitation in native and bioprosthetic aortic valves.VC 2012 Wiley Periodicals, Inc.

Key words: VALV, valvular heart disease; CATH, diagnostic cardiac catheterization;COMP, complications adult cath/intervention

INTRODUCTION

Transcatheter aortic valve implantation (TAVI) is apromising alternative to surgical aortic valve replace-ment (SAVR) for severe aortic stenosis (AS) in patientpopulations who are at high risk or unsuitable for

conventional surgery [1]. Follow-up data from multi-

center registries indicate improvement in hemodynamic

and echocardiographic indices that translate into sus-

tained benefits in functional status and quality of life

[2–4]. However, there is paucity of data evaluating

1Division of Cardiology, Ferrarotto Hospital, University of Cata-nia, Italy2Department of Cardiology Policlinico Umberto-I, Universita laSapienza Rome, Italy3Department of Cardiology PoliclinicoTor Vergata, Universita diTor Vergata, Rome, Italy4Department of Cardiology Ospedale Mauriziano, Turin, Italy5Department of Cardiology Ospedale San Carlo, Potenza, Italy6Department of Cardiology Ospedale Le Scotte, Siena, Italy7Cardiac Catheterization Laboratory Mount Sinai Hospital,New York8Excellence Through Newest Advances (ETNA) Foundation:ETNA foundation is a not for Profit entity promoting excel-lence in clinical cardiovascular research

Conflict of interest: Gian Paolo Ussia is a proctor physician for

medtronic. None of the other authors has any conflict of interest.

*Correspondence to: Gian Paolo, Ussia, Director of Interventional

Structural and Congenital Heart Disease Programme, Invasive Cardi-

ology, Division of Cardiology – Ferrarotto Hospital, University of

Catania, Via Salvatore Citelli, Catania, Italy.

E-mail: [email protected]

Received 22 February 2012; Revision accepted 5 May 2012

DOI 10.1002/ccd.24479

Published online in Wiley Online Library (wiley

onlinelibrary.com)

VC 2012 Wiley Periodicals, Inc.

Catheterization and Cardiovascular Interventions 00:000–000 (2012)

TAVI in cases of severe aortic regurgitation (AR). Wedescribe our experience in high-risk patients withsevere AR in native or degenerated bioprostheticvalves that underwent TAVI with the nitinol basedCore Valve (CRS, Medtronic) bioprosthesis.

METHODS

Patients with severe AR in native or degeneratedbioprosthetic valves underwent TAVI. Correction ofthe AR was deemed necessary due to presence ofsevere symptoms (NYHA class III–IV), severe LV dys-function with congestive heart failure and/ or pulmo-nary edema. All patients were deemed ineligible orhigh risk for SAVR by a multidisciplinary team com-posed of cardiologists, interventional cardiologists, car-diothoracic surgeons, and anesthesiologists (Table I).Informed consents were obtained from all patients orclose relatives. Preprocedure evaluation included acomprehensive clinical evaluation, transthoracic echo-cardiogram (TTE), and, if necessary, transesophagealechocardiography (TEE), coronary angiography, aortic,and iliofemoral and 64-multislice computed tomogra-phy (MSCT).

PROCEDURE

All procedures were performed with the trans femo-ral approach using local anesthesia and conscious seda-tion except one patient where general anesthesia andTEE monitoring was used (Table II). Implantation ofan 18-F CRS was performed in all patients. A tempo-rary pacemaker was placed in all cases in the absence

of a prior permanent one. TTE was performed at base-line, post procedure and at hospital discharge. Clinicalfollow up was scheduled at 30 days, 3 and 6 monthsand yearly thereafter. All patients received dual anti-platelet therapy (DAPT) with aspirin (75 mg/day) andclopidogrel 300 mg 1 day prior to the procedure andwere continued for 3 months post procedure in the ab-sence of contraindications. For patients with prior per-cutaneous coronary intervention (PCI), DAPT was con-tinued as planned. Safety and efficacy endpoints wererecorded in the hospital, at 30 days and at last followup and entered into a database. The study wasapproved by the review board of all participating insti-tutions. Statistical calculations were performed usingcommercially available software (SPSS V16.)

RESULTS

TAVI was performed in eight patients with severeAR in a native or degenerated bioprosthetic valvebetween June 2008 and 2011 at six tertiary hospitals inItaly (Ferrarotto Hospital, Catania N ¼ 2; PoliclinicoUmberto-I, Universita la Sapienza Rome N ¼ 2; Poli-clinico Tor Vergata, Rome N ¼ 1; Ospedale Le ScotteSienna N ¼ 1, Ospedale Mauriziano Turin N ¼ 1,Ospedale San Carlo, Potenza N ¼ 1). Mean age was79.6 years � 5.75 years (range 71–86 years).Therewere four male and four female patients. The LogisticEuro Score (LES) was 52.5 � 10.4%.Porcelain aortawas present in two patients. Baseline echocardiographyperformed prior to the procedure reported a mean ejec-tion fraction (LVEF) of 34.2 � 11.2%.Severe AR waspresent in all cases.

TABLE I. Clinical Characteristics at Baseline

Case #

Age

(years) Sex

NYHA

functional

class (baseline)

LVEF

(%) baseline

Logistic

Euro

Score (%) Clinical presentation and significant comorbidities

1 85 Female 3 50 50 Prior SAVR (Stentless bioprosthesis), Severe dyspnea, syncope, severe

AR and moderate MR

2 75 Female 4 30 24 Prior SAVR (Stentless bioprosthesis), severe dyspnea at rest,

2 admissions for pulmonary edema

3 71 Male 4 20 72 Prior CABG, AAA repair, SAVR (Stented bioprosthesis), prosthetic valve

endocarditis, septic embolization with severe AR and paraprosthetic leak

4 85 Male 4 50 47 Prior SAVR(Stentless bioprosthesis), acute pulmonary edema, prosthetic valve

endocarditis with severe AR and paraprosthetic leak

5 79 Male 3 45 44 Prior SAVR. Severe dyspnea. Multiple admissions for congestive heart failure.

Horizontal aorta

6 79 Female 4 29 40 Dyspnea at rest, Severe AR. Rheumatic AR.

7 86 Male 4 25 45 Severe AR, flash pulmonary edema, porcelain aorta, severe kinking of

thoracic aorta

8 82 Male 3 30 64 Prior CABG, AICD, severe dyspnea. Severe AR

9 74 Female 4 40 50 Prior CABG, Porcelain aorta

AAA, abdominal aortic aneurysm; AICD, automated implantable cardiac defibrillator; AR, Aortic regurgitation; CABG, coronary artery bypass graft-

ing; LVEF, left ventricular ejection fraction; MR, mitral regurgitation; NYHA, New York Heart Association; SAVR, surgical aortic valve replace-

ment.

2 Sarkar et al.

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

The aortic annulus (23.9 � 1.8 mm) was measuredas the maximum diameter at the lowest point of attach-ment of the valve leaflets or the maximum internal di-ameter in cases of bioprosthesis.

Procedural Outcome

All procedures except one were performed withtransfemoral route with percutaneous access and clo-sure under local anesthesia and conscious sedation.Severe concentric calcification in the Ilio-femoral vas-culature necessitated general anesthesia and surgicalcut down for vascular access in one case (case#8).The26 mm CRS device was successfully implanted in oneinstance(case #1) whereas a 29 mm CRS device wasimplanted in five patients(cases#2, 3, 4, 5, 8) and therecently introduced 31-mm device in two patients(cases#6,7). Preimplantation balloon aortic valvuloplasty (BAV)was omitted due to the absence of significant trans val-var gradient in any case and the risk of embolizationfrom friable leaflets. Rapid RV pacing for 15 secondswas used in 6 out of 8 cases to ensure stability of thedelivery catheter system (DCS) during the release ofthe inlet portion of the device. The device wasimplanted 6–8 mm below the plane of the annulus Fig-ure 1(A–H) and Figure 2. It is important to note thatthe depth of implantation and the size of the device aredifferent when a CRS is implanted for aortic stenosisor aortic regurgitation. The implantation for AS isdone at a higher level as the calcified leaflets ensure agood seal against paraprosthetic regurgitation. On theother hand, the leaflets are often not calcified in casesof aortic regurgitation. The sealing effect in this case isderived from the CRS skirt pressing against the LVOT.The other important concern is to avoid jailing the cor-onary ostia by a higher placement of a larger device.Hence placing it lower helps to position the con-strained portion of the device in the area of and justabove the native annulus to avoid ostial jailing.

The CRS frame was symmetrically and fullyexpanded thus obviating the need for any post dilation.There was immediate resolution of AR in all cases. Nopatient had valvar or paraprosthetic regurgitation (PPR)after the implantation. There were no cases requiringpermanent pacemaker (PPM) implantation after TAVI.

Follow Up

Post procedure course was uneventful in sevenpatients. One patient (case#4) developed severe hypo-tension due to retroperitoneal hemorrhage which wasmanaged with 2 Units of packed red blood cells(PRBC) transfusion. Angiography revealed a ruptureand pseudo aneurysm of the common femoral arterythat was treated successfully with deployment of twoT

ABLEII.ProceduralandFollow-U

pData

Case#

12

34

56

78

9

Typeofvalve

Stentless

(BioCor)

Stentless

(BioCor)

Stented

(Hancock)

Stentless

(Sorinfreedom)

Stented(Edwards

Perim

ount)

Native

Native

Native

Native

Approach

Transfem

oral

Transfem

oral

Transfem

oral

Transfem

oral

Transfem

oral

Transfem

oral

Transfem

oral

Transfem

oral

Transfem

oral

Access

Percutaneous

Percutaneous

Percutaneous

Percutaneous

Percutaneous

Percutaneous

Percutaneous

Percutaneous

Surgical

Anesthesia

Localþ

CS

Localþ

CS

Localþ

CS

Localþ

CS

Localþ

CS

Localþ

CS

Localþ

CS

Localþ

CS

General

Annulussize(m

m)

20.8

23

25

23

25

23

26

26.5

23

RV

pacing

Yes

15sec

No

No

Yes

15sec

Yes

15sec

Yes

15sec

Yes

15sec

Yes

15sec

Yes

15sec

CRS(m

m)

26

29

29

29

29

29

31

31

29

Postim

plantdilation

No

No

No

No

No

No

No

No

No

Postim

plantARgrade

00

00

00

00

0

PPM

No

No

No

No

No

No

No

No

No

Postprocedure

complications

None

None

None

Retroperitoneal

hem

orrhage

None

None

None

None

None

Follow

up(m

onths)

40

12

324

236

23

4

Follow-upARgrade

00

00

00

00

0

Follow

upNYHA

Class

11

21

12

22

1

Improvem

entin

LVEF

No

Yes

No

No

No

Yes

Yes

Yes

Yes

AR,aortic

regurgitation;CS,conscioussedation;CRS,core

valverevalvingsystem

;LVEF,leftventricularejectionfraction;NYHA,New

York

HeartAssociation;PPM,permanentpacem

aker;

RV,rightventricle.

Transcatheter aortic valve implantation for severe aortic regurgitation 3


Fig. 1. A–H: Successful treatment of severe native AR with a 31 mm CRS bioprosthesis. Theprosthesis is positioned 6–8 mm below the plane of the annulus. Rapid pacing is used duringthe deployment of the inlet portion of the valve. AR, aortic regurgitation; CRS, core valverevalving system.

Fig. 2. A–F: Successful treatment of severe AR in a degenerated stentless bioprosthesis. Pre(2E) and post (2F) procedure echocardiograms show complete resolution of AR. AR, aorticregurgitation.

4 Sarkar et al.


covered stents. There was no in hospital or 30-daymortality. The mean duration of follow up was 15.5� 15 months (range 2–40 months). Patients alsoremained minimally symptomatic with improvementin New York heart Association (NYHA) class in allcases. (Follow up NYHA class 1 in 5 cases andNYHA class 2 in 3 cases). Follow up TTE showed awell positioned and normally functioning prosthesisin all cases with no residual valvar regurgitation orPPR. The mean LVEF improved from 34.25 � 11.2%to 38.75 � 13.5%.The LVEF improved in fivepatients and remained unchanged in the other threepatients. All patients were prescribed dual antiplatelettherapy with aspirin and clopidogrel for 3 months.There were no reports of neurological events duringfollow up.

DISCUSSION

In contradistinction to AS that represents the endresult of aortic valve leaflet thickening and calcifica-tion, a number of disease processes involving valveleaflets, aortic root, and the annulus acting alone orin concert may give rise to severe AR [5]. The rateof temporal progression of these underlying patholo-gies and the adaptive ventricular response determinesthe manifest clinical syndrome that can broadly beclassified into the following. (1) Acute severe regur-gitation presenting with hemodynamic instability. (2)Subacute presentation of decompensated heart failure.(3) Indolent progression resulting in compensatoryleft ventricular (LV) enlargement and hypertrophyand subsequently LV dysfunction and symptomaticheart failure.

In this report the clinical presentation varied fromsevere AR accompanied with congestive heart failuremany years after SAVR (#1,2)to a more acute andsub acute picture of AR and peri-prosthetic leak inthe setting of prosthetic endocarditis with significantleaflet destruction presenting with septic embolization(#3) or intractable heart failure (#4).Likewise, thepatients with severe AR in native valves (#4–8)included rhematic heart disease (pure AR) leading tosevere heart failure(#5)as well as a more indolent pre-sentation of severe chronic AR in patients at high riskfor SAVR (#6–8).

SAVR can be performed successfully in a largenumber of patients with chronic AR with excellentpostoperative and long-term outcomes [5]. The surgi-cal risk is incremented significantly in patients withsevere left ventricular dysfunction, prior cardiac sur-gery, advanced age or concomitant comorbiditiessuch as hepatic cirrhosis, hostile thorax, chronic ob-structive pulmonary disease, severe pulmonary

hypertension, renal failure, obesity, and a high frailtyindex [6,7]. Likewise, emergent SAVR for severeAR due to infective endocarditis in native or pros-thetic valves portends a high surgical morbidity andmortality [8].

The combined effects of an ageing population andthe prevalence of AS have led to an increasing num-ber of patients being referred for SAVR. Notwith-standing the concerns about heart valve durability [9]surgical bioprosthesis have found favor as preferredimplants to avoid the need for anticoagulation and itsassociated complications [10]. As a result there is anincreasing prevalence of failing surgical bioprostheticvalves. The inherent risks of a surgical redo [11] andfavorable experience with a ViV procedure for PPRpost TAVI [12] encouraged the application of TAVIfor treatment of degenerated aortic bioprosthesis. Pre-liminary experience with both the balloon expandableEdwards Sapien valve(EST) [13] and the CRS showedfeasibility and safety [14,15] of this approach. Thevarious mechanisms of bioprosthetic valve failure andits procedural implications for TAVI have been betterunderstood [16].Improvements in catheter design anddescription of technical challenges facilitated the useof the CRS system in severely regurgitant newerstentless bioprosthesis [17]. Bedogni et al. haverecently reported a multicenter experience wherein theCRS prosthesis was implanted in failed bioprosthetic(stenotic and/or regurgitant) valves (N ¼ 25) with animplantation success rate of 100% and a 30-day and6-month follow-up mortality of 12 and 16%, respec-tively [18,19]. The recent introduction of the 31-mmCRS device has provided the definitive impetus toevaluate TAVI in cases of severe native AR. In thepresent report a 29-mm CRS device was used in 3 ofthe 4 regurgitant bioprosthesis while the 29 mm(cases#5 and# 8) and 31-mm device (cases#6 and #7)were each used in two cases of native AR. Accordingto the instructions provided by the manufacturer fortreatment of AS, a 26-mm inflow CRS is intended fora patient annulus of 20–23 mm and a 29-mm inflowCRS is intended for a patient annulus of 23–27 mmwhere as a 31-mm device is recommended for annuli26–28 mm. The sizing considerations for CRS incases of AR merit a mention. In contrast to AS, thedevice is intentionally oversized in AR to provideadequate sealing against PPR and ensure stability postdeployment. In the absence of annular calcium thesealing is provided by a pericardial skirt sewed withinthe inflow portion of the valve and the LVOT muscle.In cases of failed bioprosthesis the sewing skirt pro-vides stability and prevents overexpansion of the niti-nol frame. In cases of AR in large annuli, the LVOTgeometry may be deformed in such a way that the



maximum LVOT diameter is larger than the maximalannular diameter further necessitating the use of alarger device. Thus for an annulus or an inner diame-ter (bioprosthetic valve) of 21–24 mm a 29-mm de-vice and for annuli greater than 24 mm the 31-mmdevice are optimal for use. This strategy ensures anexcellent sealing against PPR. This strategy impliesthat the depth of implantation will be slightly lowerin cases of AR (6–8 mm) due to absence of calciumin the annulus to anchor the device and provide a sealagainst PPR. While it may be safe in cases of bio-prosthetic valves wherein the sewing ring preventscompression of the conduction tissue by the nitinolframe, it may be expected to increase the incidence ofA-V block in cases of native annuli. Curiously, noneof the patients with native AR required the implanta-tion of a PPM post TAVI or during follow up. It hasbeen suggested that the process of calcification and fi-brosis in AS alters the anatomy in such a way thatplaces the valvar leaflets in close proximity with theleft bundle branch (LBB) predisposing to injury to theHis bundle and LBBB from valve expansion[20].Whether the anatomical changes in the ventriclein some forms of AR prevent this complication isspeculative at present.

It is notable that the CRS implant remained in opti-mal position at follow up in both native and biopros-thetic valves without any late migration of the prosthe-sis. This suggests that there was no significant deleteri-ous effect of continued outward compression from thenitinol frame on the aortic root.

The success of TAVI in native AR would probablyhinge on appropriate patient selection. Patients withenlarged aortic root, a dilated ascending aorta in thesetting of connective tissue disorders and ascendingaortic dissection might be at a higher risk of failure toachieve optimal results.

CONCLUSIONS

We have confirmed the feasibility and acute proce-dural and follow-up success of TAVI in severe AR innative or degenerated bioprosthetic valves with theCRS device. Larger studies with greater number ofpatients and a longer follow up are likely to demon-strate ongoing benefits and limitations of this tech-nique.

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