Transcatheter Aortic Valve Implantation for Failing Surgical Aortic Bioprosthetic Valve

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Clinical Research

Transcatheter Aortic Valve Implantation forFailing Surgical Aortic Bioprosthetic ValveFrom Concept to Clinical Application and Evaluation (Part 2)

Nicolo Piazza, MD,* Sabine Bleiziffer, MD,* Gernot Brockmann, MD,*Ruge Hendrick, MD,* Marcus-André Deutsch, MD,* Anke Opitz, MD,*Domenico Mazzitelli, MD,* Peter Tassani-Prell, MD, PHD,† Christian Schreiber, MD,*Rüdiger Lange, MD, PHD*

Munich, Germany

Objectives This study sought to review the acute procedural outcomes of patients who underwenttranscatheter aortic valve (TAV)–in–surgical aortic valve (SAV) implantation at the German Heart Cen-ter, Munich, and to summarize the existing literature on TAV-in-SAV implantation (n � 47).

Background There are several case reports and small case series describing transcatheter aorticvalve implantation for a failing surgical aortic valve bioprosthesis (TAV-in-SAV implantation).

Methods From January 2007 to March 2011, 20 out of 556 patients underwent a TAV-in-SAV im-plantation at the German Heart Center Munich. Baseline characteristics and clinical outcome datawere prospectively entered into a dedicated database.

Results The mean patient age was 75 � 13 years, and the mean logistic European System for Car-diac Operative Risk Evaluation and Society of Thoracic Surgeons’ Risk Model scores were 27 � 13%and 7 � 4%, respectively. Of the 20 patients, 14 had stented and 6 had stentless surgical biopros-theses. Most cases (12 of 20) were performed via the transapical route using a 23-mm Edwards Sa-pien prosthesis (Edwards Lifesciences, Irvine, California). Successful implantation of a TAV in a SAVwith the patient leaving the catheterization laboratory alive was achieved in 18 of 20 patients. Themean transaortic valve gradient was 20.0 � 7.5 mm Hg. None-to-trivial, mild, and mild-to-moderateparavalvular aortic regurgitation was observed in 10, 6, and 2 patients, respectively. We experienced1 intraprocedural death following pre-implant balloon aortic valvuloplasty (“stone heart”) and 2 fur-ther in-hospital deaths due to myocardial infarction.

Conclusions TAV-in-SAV implantation is a safe and feasible treatment for high-risk patients withfailing aortic bioprosthetic valves and should be considered as part of the armamentarium in thetreatment of aortic bioprosthetic valve failure. (J Am Coll Cardiol Intv 2011;4:733–42) © 2011 bythe American College of Cardiology Foundation

From the *Department of Cardiovascular Surgery, German Heart Center, Munich, Germany; and the †Department ofAnesthesiology, German Heart Center, Munich, Germany. Dr. Piazza has reported that he is a consultant for Medtronic. Dr.Mazzitelli has reported that he is a proctor for Edwards Lifesciences. All other authors have reported that they have norelationships to disclose.

Manuscript received March 24, 2011; revised manuscript received May 3, 2011, accepted May 12, 2011.

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In 2007, Wenaweser et al. (1)reported the first case of a trans-catheter valve (Medtronic Core-Valve system, Medtronic, Min-neapolis, Minnesota) implantedinto a degenerated surgical aorticbioprosthesis. Since then, nu-merous case reports of trans-

catheter aortic valve (TAV)–in–surgical aortic valve (SAV)implantation (TAV-in-SAV) have been described witheither the Medtronic CoreValve or Edwards Sapien (Ed-wards Lifesciences, Irvine, California) bioprosthesis (2–19).

TAV-in-SAV is typically reserved for high surgical riskpatients requiring redo surgery. Nonetheless, the MedtronicCoreValve and Edwards Sapien devices were not designednor indicated for failing surgical bioprostheses.

Figure 1. Munich Case #299: Transapical 23-mm Edwards Sapien Implante

(A) Fluoroscopic identification of the Sorin Soprano (Sorin, Saluggia, Italy) bioptioning of the Edwards Sapien (Edwards Lifesciences, Irvine, California) valve 2

Abbreviationsand Acronyms

SAV � surgical aortic valve

TAV � transcatheter aorticvalve

TAVI � transcatheter aorticvalve implantation

tography demonstrated trivial aortic regurgitation.

The aim of this paper is to report on the acute clinicalresults of 20 patients who underwent TAV-in-SAVimplantation at the German Heart Center, Munich.Furthermore, we provide a review of published casereports and case series on TAV-in-SAV implantation(n � 47 cases).

Methods

Between June 2007 and March 2011, 556 patients under-went transcatheter aortic valve implantation (TAVI) at theGerman Heart Center, Munich. High surgical risk patientswith severe native aortic valve stenosis or failing surgicalaortic bioprostheses were referred for TAVI after a dedi-cated team of cardiac surgeons, cardiologists, and anesthe-siologists reached consensus that TAVI was in the best

22-mm Sorin Soprano Bioprosthesis

sis. (B) Pre-implant balloon valvuloplasty. (C) Contrast aortography and posi-m below the base ring of the Sorin Soprano valve. (D) Final contrast aor-

d in a

rostheto 4 m

CpP(rm

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interest of the patient. Patients with stented or stentlessaortic valve prostheses with internal diameters between 18and 27 mm were considered for TAV-in-SAV implanta-tion. Anatomical criteria for TAV-in-SAV were confirmed bya combination of imaging modalities: transesophageal echo-cardiography, multislice computed tomography, and angiogra-phy. Informed consent was obtained from all patients.Device description and procedure. Details of the Medtronic

oreValve and Edwards Sapien devices and technical as-ects of the procedure have been previously published.rocedures were performed in a hybrid surgical suite

20,21). Depending on underlying comorbidities, patientseceived either general anesthesia or local anesthesia (withild sedation).

Definition of outcomes. Procedural success was defined by

Figure 2. Munich Case #371: Transapical 26-mm Edwards Sapien Implante

(A) Fluoroscopic identification of the Carpentier-Edwards (CE) Perimount (EdwSapien valve 2 to 4 mm below the base ring of the CE Perimount valve. (C) Mappearance). (D) Final contrast aortography revealed no aortic regurgitation.

successful implantation of a TAV in a SAV with the patient 5

leaving the catheterization laboratory alive. Echocardiogra-phy and invasive hemodynamic pressure recordings pro-vided in-hospital transaortic valve gradients. Aortic regur-gitation was evaluated by echocardiography and contrastaortography and classified as none, mild, moderate, orsevere.Statistical analyses. Continuous variables are described asmean � SD, and dichotomous or nominal variables aredescribed as numbers and percentages. Statistical analyseswere performed using SPSS (version 17.0 for Windows,SPSS Inc., Chicago, Illinois).

Results

Baseline characteristics. From January 2007 to March 2011,

23-mm CE Perimount

ifesciences, Irvine, California) bioprosthesis. (B) Positioning of the Edwardsloyment phase of the Edwards Sapien valve (balloon has a “dumb-bell”

d in a

ards Lid-dep

56 patients underwent TAVI at the German Heart

Table 1. German Heart Center, Munich, Clinical Experience With the TAV-In-SAV Procedure Since 2007 (n � 20)

CaseNumber Patient Characteristics

Vascular Access, Type and Size of Transcatheter Valve/Surgical Bioprosthesis/Presenting Pathology Procedural Details Immediate Results and Additional Comments

1 (#146) 83-year-old woman, LES 30%, STS 6% TA 23-mm Edwards Sapien �2/23-mm Sorin Mitroflowimplanted 7 years prior/AS (MG 46 mm Hg)

1. Pre-implant BAV With 20 mm balloon2. Rapid pacing during deployment3. Second 23-mm Edwards Sapien implanted

Mild paravalvular AR/MG 44 mm Hg. Moderate-severecentral AR after the first 23-mm Edwards Sapienimplantation. After the second 23-mm EdwardsSapien, there was mild AR although the meangradient was 44 mm Hg.

2 (#153) 40-year-old man, LES 6%, STS 3% TF 29-mm Medtronic CoreValve/Homograft implanted1 year prior/AR

1. No pre-implant BAV2. No rapid pacing during deployment

Not successful. CoreValve prosthesis dislocated 2�

while semideployed. In both instances, CoreValveprosthesis was retrieved from the body. Procedureaborted and patient underwent successful surgicalvalve replacement.

3 (#286) 75-year-old woman, LES 24%, STS 16% TA 23-mm Edwards Sapien/23-mm Carpentier-EdwardsPerimount/AR

1. No pre-implant BAV Mild-moderate paravalvular AR/MG 17 mm Hg.

2. Rapid pacing during deployment

4 (#299) 73-year-old woman, LES 33%, STS 3% TA 23-mm Edwards Sapien/22-mm Sorin Sopranoimplanted 6 years prior/AS (MG 64 mm Hg)

1. Pre-implant BAV with 20-mm balloon2. Rapid pacing during deployment

Trivial paravalvular AR/MG 15 mm Hg.

5 (#309) 79-year-old man, LES 30%, STS 8% TA 23-mm Edwards Sapien/21-mm Medtronic Mosaicimplanted 5 years prior/AS (MG 66 mm Hg)


No AR/MG �20 mm Hg. Left main occlusionfollowing transcatheter aortic valve implantationfollowed by successful left main coronary stenting(in-hospital death within 30 days).

6 (#315) 75-year-old man, LES 28%, STS 6% TF 26-mm Medtronic CoreValve and TA 23-mm EdwardsSapien/24-mm Sorin Soprano implanted 4 years prior/AS(MG 64 mm Hg)

1. Pre-implant BAV with 22-mm balloon2. No rapid pacing during deployment3. Post-implant BAV with 22-mm balloon for

moderate-severe AR4. 23-mm Edwards Sapien implanted

Mild-moderate paravalvular AR/MG �20 mm Hg.Moderate-severe paravalvular AR was noted after

implantation of the first 26-mm CoreValve. A23-mm Edwards Sapien prosthesis was implantedwithin the CoreValve prosthesis and angiographysubsequently demonstrated mild-moderateparavalvular AR. A myocardial infarction wasdiagnosed on day 2 after procedure (in-hospitaldeath within 30 days).

7 (#342) 67-year-old man, LES 7%, STS 5% TA 26-mm Edwards Sapien/25-mm Carpentier-EdwardsPerimount implanted 3 years prior/AS (MG 51 mm Hg)


Mild paravalvular AR/MG 25 mm Hg

8 (#355) 91-year-old man, LES 52%, STS 11% No attempt made to deploy transcatheter valve/23-mmCarpentier Edwards Perimount implanted 5 years prior/ AS(MG 53 mm Hg)

1. Pre-implant BAV 20-mm balloon Not successful. Following BAV, severe left ventriculardysfunction, hemodynamic instability, and cardiacarrest without recovery (intraprocedural death).

9 (#371) 75-year-old woman, LES 26%, STS 4% TA 26-mm Edwards Sapien/23-mm Carpentier-EdwardsPerimount Magna implanted 7 years prior/AS(MG 77 mm Hg)


No AR/MG 24 mm Hg

10 (#376) 87-year-old woman, LES 27%, STS 8% TA 23-mm Edwards Sapien/21-mm Medtronic Mosaicimplanted 8 years prior/AR


No AR/MG 14 mm Hg

11 (#401) 80-year-old woman, LES 28%, STS 6% TA 26-mm Edwards Sapien/25-mm BioValsalva implanted 4years prior/AR

1. No pre-implant balloon dilation2. Rapid pacing during deployment

No AR/MG 20 mm Hg

12 (#415) 71-year-old woman, LES 13%, STS 6% TA 23-mm Edwards Sapien/21-mm Medtronic Freestyle[stentless] implanted 4 years prior/AR


No AR/MG 19 mm Hg

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Table 1. Continued

CaseNumber Patient Characteristics

Vascular Access, Type and Size of Transcatheter Valve/Surgical Bioprosthesis/Presenting Pathology Procedural Details Immediate Results and Additional Comments

13 (#416) 79-year-old woman, LES 58%, STS 7% TA 23-mm Edwards Sapien/23-mm Sorin Mitroflowimplanted 7 years prior/combined AR and AS(MG 31 mm Hg)


No AR/MG 16 mm Hg

14 (#450) 71-year-old man, LES 17% STS 2% TA 23-mm Edwards Sapien 1� and TF 23-mm EdwardsSapien 1�/23-mm St. Jude Medical Toronto, Freestyle[stentless] implanted 4 years prior/AR

1. No pre-implant BAV2. Rapid pacing during deployment

Mild paravalvular leak immediately followingimplantation. After transapical closure,echocardiography identified new severe central ARdue to a malcoapting leaflet in the noncoronarysinus position. Patient underwent transfemoralimplantation of a second 23-mm Edwards Sapien.No AR/MG

15 (#453) 71-year-old woman, LES 11%, STS 3% TA 23-mm Edwards Sapien/21-mm homograft implanted14 years prior/AR


No AR/MG 17 mm Hg

16 (#464) 89-year-old man, LES 23%, STS 10% TA 26-mm Edwards Sapien/27-mm Biocor � aortic rootreplacement 16 years prior/AR


Mild AR/MG 20 mm Hg

17 (#468) 82-year-old woman, LES 37%, STS 7% TA 23-mm Carpentier-Edwards Sapien/23-mm Carpentier-Edwards Perimount Magna implanted 3 years prior/AS(MG 65 mm Hg)

1. Pre-implant BAV with 20 mm balloon2. Rapid pacing during deployment

Mild AR/MG N/A

18 (#481) 62-year-old man, LES 7%, STS 3% TF 29-mm CoreValve/Surgical stented bioprosthesis in 1985and 27-mm homograft implanted 15 yearsprior/AR


Mild AR/invasive PG 11 mm Hg

19 (#499) 79-year-old woman, LES 18%, STS 5% TA 23-mm Edwards Sapien XT/23-mm Carpentier-EdwardsPerimount implanted 10 years prior/AS(MG 63 mm Hg)


No AR/MG 18 mm Hg

20 (#502) 76-year-old female, LES 7%, STS 3% TA 23-mm Edwards Sapien XT/21-mm Carpentier-EdwardsPerimount/AS (MG 67 mm Hg)


No AR/MG N/A

Biocor and Toronto are products of St. Jude Medical (Minneapolis, Minnesota). BioValsalva (Vascutek, Terumo, Newmains, Scotland). CoreValve, Freestyle, and Mosaic are products of Medtronic CV Luxembourg s.a.r.l. (Tolochenaz, Switzerland) or Medtronic (Minneapolis,

Minnesota). Mitroflow and Soprano are products of Sorin Group (Saluggia, Italy). Perimount and Sapien are products of Edwards Lifesciences (Irvine, California).

AR � aortic regurgitation; AS � aortic stenosis; BAV � balloon aortic valvuloplasty; LES � logistic European System for Cardiac Operative Risk Evaluation; MG � mean gradient; N/A � not available; PG � peak gradient; SAV � surgical aortic valve; STS � Society of

Thoracic Surgeons predicted risk of mortality score; TA � transapical; TAV � transcatheter aortic valve; TF � transfemoral.

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Table 2. Summary Table of Published Case Reports and Case Series of TAV-In-SAV Procedures Since 2007 (n � 47)

First Author (Ref. #) Patient CharacteristicsVascular Access, Type and Size of Transcatheter Valve/

Surgical Bioprosthesis/Presenting Pathology Procedural Details Results

Wenaweser et al. (1) 80-year-old man, LES 36% TF 26-mm Medtronic CoreValve/23-mm Sorin Mitroflow/AR 1. No Pre-implant BAV2. No rapid pacing during deployment

No AR/MG 12 mm Hg

Walther et al. (2) 82-year-old woman, LES 21%, STS 9.2% TA 23-mm cuffed Edwards Sapien/21-mm Carpentier-Edwards Perimount/AS

1. Pre-implant BAV (balloon size N/A)2. Rapid pacing during deployment

No AR/MG 17 mm Hg

Klaaborg et al. (3) 82-year-old woman, LES 53% TA 23-mm Edwards Sapien/21-mm Sorin Mitroflow/AS 1. Pre-implant BAV (23-mm balloon)2. Rapid pacing during deployment

Trivial transvalvular AR/PG 40 mm Hg

Kelpis et al. (4) 80-year-old man, LES 37.3%, STS 27.5% TA 23-mm Edwards Sapien/25-mm St. Jude Torontostentless/AR

1. Pre-implant BAV (20-mm balloon)2. Rapid pacing during deployment

No AR “good hemodynamic function”

Rodés-Cabau et al. (22) 84-year-old woman, STS 48% TA 23-mm Edwards Sapien/23-mm Medtronic Freestyle[stentless]/AR


Trivial AR/MG 17 mm Hg

Attias et al. (5) 80-year-old man, LES 26%, STS 18% TF 29-mm Medtronic CoreValve/25-mm stentless Xenograft(manufacturer not reported)/AR


No AR/MG 3 mm Hg

Schmoeckel et al. (6) 72-year-old man, LES 26%, STS 18% TA 26-mm Edwards Sapien/24-mm aortic allograft as aminiroot (manufacturer not reported)/AR

1. Pre-implant BAV (balloon size N/A)2. Rapid pacing during deployment

Trivial paravalvular AR/PG 9 mm Hg

Ussia et al. (7) 85-year-old woman, LES 45% TF 26-mm Medtronic CoreValve/21-mm St. Jude Biocor[stentless]/AR

1. No pre-implant BAV2. Rapid pacing during deployment3. Post-implant dilation with 25-mm

nucleus balloon

Moderate-severe paravalvular AR(reduced to moderate with post-implant dilation)

Napodano et al. (8) 84-year-old woman, LES 31.8% TF 29-mm Medtronic CoreValve/25-mm St. Jude Biocor[stentless]/AR


nucleus balloon

Trivial paravalvular AR “no transvalvulargradient”

Attias et al. (9) 70-year-old man, LES 35% TF 26-mm Medtronic CoreValve/21-mm Carpentier-EdwardsPerimount/AR

Information not provided No AR/No information provided forgradient

Ng et al. (10) 82-year-old man, LES 28% TA 26-mm Edwards Sapien/23-mm Medtronic Freestyle[stentless]/AR

1. No information about BAV2. Rapid pacing during deployment3. 2 Edwards Sapiens implanted

Severe transvalvular AR after first valveimplantation. A second 26-mmEdwards device was implanted andassociated with mild transvalvular AR

Olsen et al. (23) 86-year-old man, LES 30%(2 previous cardiac operations)

Right subclavian artery 29-mm Medtronic CoreValve/23-mm homograft [stentless]/AR

1. No information about BAV2. No information on rapid pacing

No information available about post-implant AR or transvalvular gradient

Dainese et al. (11) 48-year-old woman, LES 12%(3 previous cardiac operations)

TA 23-mm Edwards Sapien/21-mm CryoLife Bravo 400[stentless] for miniroot technique/AS

1. Pre-implant BAV2. Rapid pacing during deployment

No AR/PG 18 mm Hg

Sharp et al. (12) 82-year-old man, LES 64%, STS 46% Left subclavian artery 23-mm Edwards Sapien/23-mm Medtronic Freestyle [stentless]/AR


No AR/MG 10 mm Hg and PG 24 mm Hg

Ferrari et al. (14) 80-year-old woman, LES 59% TA 23-mm Edwards Sapien/23-mm Sorin Mitroflow/AR 1. No pre-implant BAV2. Rapid pacing during deployment

No AR/MG 10 mm Hg and PG 18 mm Hg

Maroto et al. (15) (n � 2) 84-year-old man, LES 25% TA 23-mm Edwards Sapien/25-mm Medtronic Hancockstandard/combined AS and AR


Minimal transvalvular AR/PG 17 mm Hg

84-year-old man, LES 18% TA 23-mm Edwards Sapien/25-mm Medtronic, Hancockstandard/combined AS and AR


Minimal transvalvular AR/PG 13 mm Hg


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Table 2. Continued

First Author (Ref. #) Patient CharacteristicsVascular Access, Type and Size of Transcatheter Valve/

Surgical Bioprosthesis/Presenting Pathology Procedural Details Results

Khawaja et al. (16) (n � 4) 66-year-old man, LES 25% TF 26-mm Medtronic CoreValve/21-mm Sorin Mitroflow/combined AS and AR


No AR/PG 30 mm Hg

76-year-old man, LES 19% TF 26-mm Medtronic CoreValve/23-mm Carpentier-EdwardsPerimount/AR


No AR/PG 39 mm Hg

85-year-old woman, LES 38% TF 26-mm Medtronic CoreValve/Carpentier-EdwardsPerimount (size not available)/AR


Mild paravalvular AR/PG 30 mm Hg

48-year-old woman, LES 12% TF 26-mm Medtronic CoreValve/25-mm CryoLife O’Brien[stentless]/AS


balloon

Mild paravalvular AR/PG 35 mm Hg

Webb et al. (17) (n � 10)* 87-year-old, LES 31%, STS 10% TA 23-mm Edwards Sapien/25-mm Carpentier-EdwardsPerimount/combined AS and AR

No specific details except that authorsstate that pre-implant BAV isavoided in patients withpredominant AR and encouraged inthose with AS

No AR/MG 11 mm Hg

83-year-old, LES 38%, STS 10% TA 23-mm Edwards Sapien/23-mm Carpentier-EdwardsPerimount/combined AS and AR

No AR/MG 24 mm Hg

85-year-old LES 39%, STS 12% TA 23-mm Edwards Sapien/23-mm Carpentier-EdwardsPerimount/AS

No AR/MG 27 mm Hg

86-year-old, LES 33%, STS 11% TA 23-mm Edwards Sapien/21-mm Ionescu-Shileystandard/AS

No AR/MG 23 mm Hg

86-year-old, LES 33%, STS 10% TA 26-mm Edwards Sapien/25-mm Carpentier-EdwardsPerimount/AS

No AR/MG 13 mm Hg

83-year-old, LES 46%, STS 11% TA 23-mm Edwards Sapien/21-mm Carpentier-EdwardsPerimount/AS

Mild AR/MG 24 mm Hg

78-year-old, LES 20%, STS 5% TA 23-mm Edwards Sapien/21-mm ShelhighSuperStentless/AS

No AR/MG 16 mm Hg

84-year-old, LES 24%, STS 12% TA 23-mm Edwards Sapien/21-mm MedtronicFreestyle/AR

No AR/MG 11 mm Hg

82-year-old, LES 34%, STS 11% TA 23-mm Edwards Sapien/21-mm MedtronicMosaic/combined AS and AR

No AR/MG 30 mm Hg

67-year-old, LES 14%, STS 16% TF 23-mm Edwards Sapien/23-mm Carpentier-EdwardsPerimount/combined AS and AR

Mild AR/MG 21 mm Hg

Seiffert et al. (19) (n � 4) 83-year-old man, LES 89%, STS 35% TA 23-mm Edwards Sapien/23-mm St. Jude Biocor[stentless]/AS


AR grade N/A/MG 20 mm Hg

78-year-old man, LES 52%, STS 30% TA 23-mm Edwards Sapien/21-mm Medtronic Hancockstandard/AS


No AR/MG 30 mm Hg

88-year-old man, LES 42%, STS 20% TA 23-mm Edwards Sapien/23-mm Medtronic Hancockstandard/AR


Mild paravalvular AR/MG 12 mm Hg

73-year-old man, LES 48%, STS 17% TA 23-mm Edwards Sapien/25-mm Medtronic HancockII/AS


No AR/MG 12 mm Hg


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Center, Munich. Of those, 20 patients with a failing surgicalbioprosthesis underwent a TAV-in-SAV procedure. Base-line and procedural characteristics and outcomes are sum-marized in Table 1.

The mean patient age was 75 � 13 years and the meanlogistic European System for Cardiac Operative Risk Eval-uation and Society of Thoracic Surgeons’ Risk Model scoreswere 27 � 13% and 7 � 4%, respectively. Patients presentedon average 5 � 2 years after their primary valve operation.Of the 20 patients, 14 had stented and 6 had stentless surgicalbioprostheses. Primary aortic stenosis, aortic regurgitation, andcombination aortic stenosis/regurgitation were present in 10, 9,and 1 patient, respectively.Procedural characteristics and clinical outcomes. Most cases12 of 20) were performed via the transapical route using

23-mm Edwards Sapien prosthesis. Pre-implant bal-oon aortic valvuloplasty was performed in those patientsith primary aortic stenosis but not in those with primary

ortic regurgitation. Procedural success was achieved in8 of 20 patients (see “Unsuccessful TAV-in-SAV im-lantations” section). The mean post-procedural transaorticalve gradient was 20.0 � 7.5 mm Hg. Except for Case146, who underwent implantation of 2 23-mm Edwardsapien bioprostheses, all patients had a post-proceduralransaortic valve gradient below 25 mm Hg. None-to-rivial, mild, and mild-to-moderate paravalvular aorticegurgitations were observed in 10, 6, and 2 patients,espectively.

No patient experienced a stroke or need for permanentacemaking. Figures 1 and 2 demonstrate the fluoroscopicmages of 2 successful TAV-in-SAV procedures.Unsuccessful TAV-in-SAV implantations. A TAV was notimplanted in 2 of the 20 TAV-in-SAV patients. In thefirst patient with a failing homograft and severe aorticregurgitation (Case #153), the CoreValve prosthesis dis-located into the ascending aorta on 2 attempts; in bothinstances, the prosthesis was retrieved from the body inits semideployed state. The procedure was aborted andthe patient underwent successful conventional aorticvalve replacement. In this case, we did not use rapidpacing during valve deployment. The large stroke vol-umes likely contributed to the instability of the prosthesisduring valve deployment. Rapid pacing during valvedeployment is routinely used in patients with severeaortic regurgitation. In the second case (#355), a “stoneheart” developed after pre-implant balloon aortic valvu-loplasty leading to intraprocedural death despite imme-diate institution of cardiopulmonary bypass.In-hospital deaths. There were 2 in-hospital post-procedural deaths (Cases #309 and #315). In Case #309,immediate left main coronary occlusion occurred afterdeployment of the 23-mm Edwards Sapien within a21-mm Medtronic Mosaic valve (Fig. 3). Despite suc-
cessful left main coronary stenting, the patient died onT K B Su

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hospital day 2 from multiorgan failure. In fact, pre-procedural imaging revealed “bulky calcifications” of thenative aortic valve and a surgical stent post overlying the ostiumof the left main coronary artery (Fig. 3). The orientation of thestent posts relative to the coronary ostia is now assessedregularly (Fig. 3D). In Case #315, moderate-to-severe para-valvular aortic regurgitation was documented after implantinga 26-mm CoreValve into a 24-mm Sorin Soprano (SorinGroup, Saluggia, Italy) bioprosthesis. A 23-mm EdwardsSapien was subsequently implanted within the 26-mm Core-Valve. Despite a reduction in the aortic regurgitation grade, thepatient died on hospital day 3 from cardiogenic shock; amyocardial infarction was suspected based on rising cardiacbiomarkers.TAV-in-SAV implantation. A SUMMARY OF PUBLISHED CASE

ERIES AND CASE REPORTS. We performed a search in

Figure 3. Munich Case #309: A Transapical 23-mm Edwards Sapien Implan

(A) Parasagittal multislice computed tomography view demonstrates the stthesis overlying the ostia of the left main coronary artery. (B) Contrast aortleft coronary sinus. (C) After deployment of the Edwards Sapien valve, thermultislice computed tomography view demonstrating normal orientation oroutinely performed before transcatheter aortic valve–in–surgical aortic val

PubMed for peer-reviewed papers on TAV for failing

surgical bioprosthetic valves. From January 2007 to January2011, 47 cases of TAV-in-SAV were identified in eithercase report or case series format (Table 2) (22,23).

Salient features of these case reports can be summarizedas follows. Patients were typically elderly and at high orprohibitive surgical risk. They presented 6 to 26 years aftertheir primary valve operation. A significant number ofpatients presented with severe aortic regurgitation, which isatypical for patients currently undergoing TAVI. Patientshad a prior history of either stented or stentless valvereplacement (labeled valve size: 21 to 25 mm). The “smaller”23-mm Edwards Sapien and “smaller” 26-mm CoreValveprostheses were implanted in the vast majority of reportedcases. Heterogeneous practice patterns were apparent withrespect to the use of pre-implant balloon aortic valvuloplastyand/or rapid pacing during valve deployment. Significant

a 21-mm Medtronic Mosaic Bioprosthetic Valve

ost of the Medtronic Mosaic (Medtronic, Tolochenaz, Switzerland) biopros-hy demonstrates a large calcific mass (radiolucent) in the region of theimmediate obstruction of the left main coronary ostia. (D) Short-axisrosthesis stent posts relative to coronary ostia. This examination is nowlantation.

ted in

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reductions in transvalvular gradients and/or aortic regurgitation

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were observed with either the Edwards Sapien or CoreValvebioprosthesis. In some cases, however, the transvalvulargradient remained considerably elevated (�20 mm Hg).Nevertheless, the investigators noted that there wasadequate improvement in valve function to positivelyinfluence the quality of life in these otherwise “high orprohibitive” surgical risk patients.

The average transaortic valve gradient after primaryaortic valve surgery with the Carpentier-Edwards Peri-mount bioprosthesis (Edwards Lifesciences) has beenreported to be approximately 14 � 6 mm Hg (24). In ourohort, the average transaortic valve gradient followingAV-in-SAV was 20.0 � 7.5 mm Hg.Coronary obstruction following TAV-in-SAV implan-

ation is a rare but life-threatening complication thatequires immediate cardiopulmonary resuscitation andeinstitution of coronary blood flow. A recent publica-ion described 2 cases of coronary obstruction duringreatment of a degenerated Mitroflow (Sorin) biopros-heses (25). This may suggest that certain surgical bio-rostheses may increase the risk of coronary obstruction

n the setting of TAV-in-SAV implantation. In our experi-nce, we observed coronary obstruction in treating a degener-ted Medtronic Hancock bioprosthesis. We did not observe,owever, coronary obstruction while treating 2 Sorin Sopranond 2 Sorin Mitroflow bioprostheses.

onclusions

TAV-in-SAV implantation is currently considered anoff-label indication. At this time, both Medtronic Cor-eValve and Edwards Lifesciences are pursuing TAV-in-SAV expanded eligibility trials for CE mark approval. Ifthe promising findings here are confirmed in largerstudies with longer follow-up, TAV-in-SAV implanta-tion may become an alternative in high risk redo surgerypatients.

Reprint requests and correspondence: Dr. Nicolo Piazza, Car-diovascular Surgery Department, German Heart Center Munich,Lazarettstrasse 36, 80636 Munich, Germany. E-mail: [email protected].

REFERENCES

1. Wenaweser P, Buellesfeld L, Gerckens U, Grube E. Percutaneousaortic valve replacement for severe aortic regurgitation in degeneratedbioprosthesis: the first valve in valve procedure using the CoreValverevalving system. Catheter Cardiovasc Interv 2007;70:760–4.

2. Walther T, Kempfert J, Borger MA, et al. Human minimally invasiveoff-pump valve-in-a-valve implantation. Ann Thorac Surg 2008;85:1072–3.

3. Klaaborg KE, Egeblad H, Jakobsen CJ, et al. Transapical transcathetertreatment of a stenosed aortic valve bioprosthesis using the EdwardsSAPIEN transcatheter Heart Valve. Ann Thorac Surg 2009;87:1943–6.

4. Kelpis TG, Mezilis NE, Ninios VN, Pitsis AA. Minimally invasive
transapical aortic valve-in-a-valve implantation for severe aortic regur- v
gitation in a degenerated stentless bioprosthesis. J Thorac CardiovascSurg 2009;138:1018–20.

5. Attias D, Himbert D, Hvass U, Vahanian A. “Valve-in-valve” implan-tation in a patient with stentless bioprosthesis and severe intrapros-thetic aortic regurgitation. J Thorac Cardiovasc Surg 2009;138:1020–2.

6. Schmoeckel M, Boekstegers P, Nikolaou K, Reichart B. First success-ful transapical aortic valve implantation after aortic allograft replace-ment. J Thorac Cardiovasc Surg 2009;138:1016–7.

7. Ussia GP, Barbanti M, Tamburino C. Treatment of severe regurgita-tion of stentless aortic valve prosthesis with a self-expandable biologicalvalve. J Invasive Cardiol 2009;21:E51–4.

8. Napodano M, Cutolo A, Fraccaro C, et al. Totally percutaneous valvereplacement for severe aortic regurgitation in a degenerating biopros-thesis. J Thorac Cardiovasc Surg 2009;138:1027–8.

9. Attias D, Himbert D, Brochet E, Laborde JC, Vahanian A. “Valve-in-valve” implantation in a patient with degenerated aortic bioprosthe-sis and severe regurgitation. Eur Heart J 2009;30:1852.

10. Ng A, van der Kley F, Delgado V, et al. Percutaneous valve-in-valveprocedure for severe paravalvular regurgitation in aortic bioprosthesis.J Am Coll Cardiol Img 2009;2:522–3.

11. Dainese L, Fusari M, Trabattoni P, Biglioli P. Redo in aortichomograft replacement: transcatheter aortic valve as a valid alternativeto surgical replacement. J Thorac Cardiovasc Surg 2010;139:1656–7.

12. Sharp AS, Michev I, Colombo A. First trans-axillary implantation ofEdwards Sapien valve to treat an incompetent aortic bioprosthesis.Catheter Cardiovasc Interv 2010;75:507–10.

13. Bruschi G, DeMarco F, Oreglia J, et al. Transcatheter aortic valve-in-valve implantation of a CoreValve in a degenerated aortic bioprosthesis.J Cardiovasc Med (Hagerstown) 2010;11:182–5.

14. Ferrari E, Marcucci C, Sulzer C, von Segesser LK. Which availabletransapical transcatheter valve fits into degenerated aortic bioprosthe-ses? Interact Cardiovasc Thorac Surg 2010;11:83–5.

15. Maroto LC, Rodriguez JE, Cobiella J, Marcos P. Transapical off-pumpaortic valve-in-a-valve implantation in two elderly patients with a degen-erated porcine bioprosthesis. Eur J Cardiothorac Surg 2010;37:738–40.

16. Khawaja MZ, Haworth P, Ghuran A, et al. Transcatheter aortic valveimplantation for stenosed and regurgitant aortic valve bioprosthesesCoreValve for failed bioprosthetic aortic valve replacements. J Am CollCardiol 2010;55:97–101.

17. Webb JG, Wood DA, Ye J, et al. Transcatheter valve-in-valve implantationfor failed bioprosthetic heart valves. Circulation 2010;121:1848–57.

18. Kempfert J, Van Linden A, Linke A, et al. Transapical off-pumpvalve-in-valve implantation in patients with degenerated aortic xeno-grafts. Ann Thorac Surg 2010;89:1934–41.

19. Seiffert M, Franzen O, Conradi L, et al. Series of transcathetervalve-in-valve implantations in high-risk patients with degeneratedbioprostheses in aortic and mitral position. Catheter Cardiovasc Interv2010;76:608–15.

20. Piazza N, Grube E, Gerckens U, et al. Procedural and 30-dayoutcomes following transcatheter aortic valve implantation using thethird generation (18 Fr) corevalve revalving system: results from themulticentre, expanded evaluation registry 1-year following CE markapproval. EuroIntervention 2008;4:242–9.

21. Bleiziffer S, Ruge H, Mazzitelli D, et al. Results of percutaneous andtransapical transcather aortic valve implantation performed by a surgicalteam. Eur J Cardiothorac Surg 2009;35:615–20.

22. Rodés-Cabau J, Dumont E, Doyle D, Lemieux J. Transcathetervalve-in-valve implantation for the treatment of stentless aortic valvedysfunction. J Thorac Cardiovasc Surg 2010;140:246–8.

23. Olsen LK, Engstrom T, Sondergaard L. Transcatheter valve-in-valveimplantation due to severe aortic regurgitation in a degenerated aortichomograft. J Invasive Cardiol 2009;21:E197–200.

24. Yoganathan A, Heinrich R, Fontaine A. Fluid Dynamics of ProstheticValves. Philadelphia, PA: W. B. Saunders, 1997.

25. Gurvitch R, Cheung A, Bedogni F, Webb JG. Coronary obstructionfollowing transcatheter aortic valve-in-valve implantation for failedsurgical bioprostheses. Catheter Cardiovasc Interv 2011;77:439–44.

Key Words: aortic regurgitation � aortic stenosis � surgicalortic valve � transcatheter aortic valve implantation �
alve-in-valve.
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Transcatheter Aortic Valve Implantation for Failing Surgical Aortic Bioprosthetic Valve