transvenous, antegrade melody valve-in-valve implantation ... · the melody valve (medtronic,...

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Transvenous, Antegrade Melody Valve-in-ValveImplantation for Bioprosthetic Mitral andTricuspid Valve Dysfunction
A Case Series in Children and Adults
Michael W. Cullen, MD,* Allison K. Cabalka, MD,y Oluseun O. Alli, MBBS,zSorin V. Pislaru, MD, PHD,* Paul Sorajja, MD,* Vuyisile T. Nkomo, MD, MPH,*

Joseph F. Malouf, MD,* Frank Cetta, MD,*y Donald J. Hagler, MD,*yCharanjit S. Rihal, MD, MBA*

Rochester, Minnesota; and Birmingham, Alabama

Objectives The purpose of this study was to report the results of percutaneous valve-in-valve therapyusing the Melody valve (Medtronic, Minneapolis, Minnesota) for patients with degenerated mitral andtricuspid bioprosthetic valves.

Background Open surgery for replacement of degenerated bioprosthetic valves is associated withmorbidity and mortality.

Methods Nineteen patients (median age 65 years, range 10 to 88 years; 7 males) with degeneratedmitral (n ¼ 9) or tricuspid (n ¼ 10) bioprosthetic valves underwent transvenous valve-in-valveimplantation of the Melody valve.

Results In the mitral patients, the mean Society of Thoracic Surgeons mortality score was 13.3 �5.6%. All patients had a prosthetic valve mean diastolic inflow gradient �5 mm Hg. Moderate or worseregurgitation was present in 7 of 9 mitral and 7 of 10 tricuspid patients. Implantation of a Melodyvalve was successful in all. Among the mitral patients, mean diastolic gradient decreased from 12.3 �4.6 mm Hg to 5.2 � 2 mm Hg (p < 0.01). Residual regurgitation was trivial to mild in 6, mild tomoderate in 2, and moderate in 1 patient. Among the tricuspid patients, mean diastolic gradientdecreased from 10.0 � 4.3 mm Hg to 5.6 � 2.5 mm Hg (p < 0.01). Residual regurgitation was trivial tomild in 9 and mild to moderate in 1 patient. New York Heart Association functional class improved in17 of 19 patients (p < 0.01). No periprocedural deaths, myocardial infarctions, strokes, or valveembolizations occurred. Vascular access site complications occurred in 4 patients.

Conclusions Percutaneous valve-in-valve implantation of the Melody valve in the mitral or tricuspidposition for treatment of bioprosthetic valve dysfunction is feasible and can lead to significantsymptomatic improvement in carefully selected high-risk patients. (J Am Coll Cardiol Intv2013;6:598–605) ª 2013 by the American College of Cardiology Foundation

From the *Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota; yDivision of Pediatric Cardiology, Mayo

Clinic, Rochester, Minnesota; and the zDivision of Cardiovascular Disease, University of Alabama–Birmingham, Birmingham,

Alabama. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Manuscript received October 2, 2012; revised manuscript received January 1, 2013, accepted February 2, 2013.

http://dx.doi.org/10.1016/j.jcin.2013.02.010



Abbreviationsand Acronyms

ICE = intracardiac

echocardiography

NYHA = New York Heart

Association

STS = Society of Thoracic

Surgeons

TEE = transesophageal

echocardiography

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Bioprosthetic valves are frequently used for patients withacquired and congenital cardiac disease despite the valves’tendency toward earlier degeneration and valvular dysfunc-tion (1). For patients who require treatment of degeneratedbioprosthetic valves, repeat sternotomy and open surgerycarry higher risk, especially in older patients with comorbidconditions (2,3). Transcatheter implantation of percutane-ously delivered valves into degenerated bioprostheses (i.e.,valve-in-valve therapy) has emerged as an alternative to opensurgery. Reports have described valve-in-valve therapy in all4 native valve positions (4–17), but the greatest applicationhas been for aortic bioprosthetic degeneration.

The Melody valve (Medtronic, Minneapolis, Minnesota)is a bovine jugular venous valve designed and approved forpercutaneous implantation in the pulmonary position inpatients with dysfunctional right ventricular to pulmonaryartery conduits and pulmonary bioprosthetic valves orhomografts (18,19). Valve-in-valve Melody implantationhas been reported for treatment of degenerated tricuspidbioprosthesis (5,20,21), but not for the treatment of left-sided degenerated bioprosthetic valves.

This series describes the clinical feasibility and efficacy ofpercutaneous implantation of the Melody valve in patientswith degenerated bioprosthetic mitral or tricuspid valves.

Methods

Patient population. The study was approved by the MayoClinic Institutional Review Board. From July 2011 throughNovember 2012, 19 patients underwent percutaneousimplantation of the Melody valve into the mitral (n ¼ 9) ortricuspid (n ¼ 10) position. Patients were consideredcandidates for the procedure if they had significant bio-prosthetic mitral or tricuspid valve dysfunction (eitherstenosis, regurgitation, or both) with comorbid conditionsthat would preclude a repeat sternotomy and valve replace-ment. Consultation with a cardiac surgeon occurred beforeproceeding with percutaneous valve-in-valve therapy. Allpatients or parents received detailed instruction on thepotential risks of the procedure, including the off-label use ofthe Melody valve. Alternatives, including repeat open surgeryand medical therapy, were carefully discussed. All patients orparents provided informed consent for the procedure.Mitral valve-in-valve procedure. The mitral valve-in-valveprocedure was performed in the cardiac catheterizationlaboratory (Fig. 1). Patients were placed under generalendotracheal anesthesia. Intraprocedural imaging was per-formed with transesophageal echocardiography (TEE).Transseptal puncture was performed using standard tech-niques. The atrial septum was sequentially dilated with 14-Fand 21-F dilators. A 20-F Dry Seal sheath (Gore Medical,Flagstaff, Arizona) was introduced into the right femoralvein, and an 8.5-F medium curve Agilis sheath (St. JudeMedical, St. Paul, Minnesota) was placed in the left atrium

over a Torayguide guidewire (Toray Industries, Tokyo,Japan). Unfractionated heparin (100 U/kg) was administeredto ensure adequate systemic anticoagulation, and the acti-vated clotting time was monitored regularly to maintaina level >250 s.

Coronary angiography was performed to delineate thecourse of the left anterior descending coronary artery and itsmajor branches before left ventricular puncture. The leftventricular apical puncture was performed with an 18-gaugeneedle or a One-Step Centesis Catheter (Merit MedicalSystems, South Jordan, Utah) under fluoroscopic and trans-thoracic echocardiography guidance. A 6-F sheath was thenadvanced into the left ventricle over a 0.038-inch wire (22).

An exchange length 0.035-inch angled extra-supportglide wire (Terumo, Somerset, New Jersey) was introducedthrough the Agilis sheath into the left atrium and advancedacross the mitral bioprosthesis into the left ventricle. Theglide wire was snared in the left ventricle and exteriorizedthrough the left ventricular apical sheath, creating a wire railbetween the right femoral vein and the left ventricular apex(Fig. 1C). In selected cases, a 5-F pacing catheter was
advanced into the right ventriclevia the left femoral vein. Theinternal diameter of the dys-functional valve was measuredwith TEE, and balloon sizingperformed with a compliantballoon in selected cases. Balloonsizing was not performed if itwas apparent the internal diam-eter of the existing bioprostheticvalve would support the Melodyvalve. In all cases, the Melody valve was mounted onto the 22-mm Ensemble deliverysystem (Medtronic) and delivered antegrade via the rightfemoral vein, across the atrial septum, and into thedysfunctional prosthesis over the arteriovenous rail. Thevalve was carefully positioned across the bioprosthesis anddeployed under rapid ventricular pacing using fluoroscopyand TEE guidance. The left ventricular apical puncture sitewas subsequently closed with a 6-mm Amplatzer VascularPlug II (AVP II, St. Jude Medical) that expanded to fill theleft ventricular apical defect. Anticoagulation was reversedwith protamine, and the venous sheath site was closed witha figure-of-eight suture (23).Tricuspid valve-in-valve procedure. The tricuspid valve-in-valve procedure was performed in the cardiac catheteri-zation laboratory under general anesthesia for 9 patients andconscious sedation for 1 patient (Fig. 2). Imaging was per-formed with intracardiac echocardiography (ICE) in 7patients and TEE in 3 patients. The valve was deliveredeither through the right internal jugular vein or the rightfemoral vein. An extra-stiff 0.035-inch exchange lengthAmplatz wire was advanced into a distal pulmonary artery

Figure 1. Mitral Valve Implantation

(A) A severely stenotic mitral valve bioprosthesis on 3-dimenstional transesophageal echocardiography (TEE). (B) Snare of the transseptal catheter via the leftventricular apex. (C) A photo of the femoral vein to left ventricular rail externalized through the left thoracic cavity (previously published and reproduced withpermission) (16). (D) Balloon valvuloplasty of the dysfunctional bioprosthetic valve on 3-dimensional TEE. (E) A post-implant view of the deployed Melody valve froma ventricular view on 3-dimensional TEE. (F) The deployed Melody valve inside the surgically placed bioprosthetic valve. The occluder plug used to close the leftventricular puncture is also visible.

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through a balloon wedge catheter. Balloon sizing of theprosthesis was then performed with a 22-mm Z-Med IIballoon (NuMed, Hopkinton, New York). The Melodyvalve was mounted onto the 22-mm Ensemble deliverysystem, advanced over the exchange wire, and maneuveredacross the dysfunctional tricuspid prosthesis. Position wasconfirmed, and the valve was deployed under fluoroscopicand echocardiographic imaging. The venous access site wassubsequently closed with a figure-of-eight suture (23).Data analysis. Society of Thoracic Surgeons (STS) riskscore was calculated for the mitral valve patients using themitral valve replacement algorithm. Clinical events formyocardial infarction, stroke, emergency surgery, bleeding,and vascular complications were defined using standardcriteria (24–26). Continuous variables were expressed asmean � SD if normally distributed or median with inter-quartile range if skewed. Normal distribution was testedwith the Shapiro-Wilk statistic, and logarithmic trans-formations were performed when appropriate. Paired t testsand Wilcoxon signed rank tests compared pre- and post-procedure variables within patients. We defined surveillanceperiod as the time between the procedure and the lastclinical contact with the patient. Analyses were performedusing JMP statistical software, version 9 (SAS Institute,Cary, North Carolina).

Results

Patient population. Table 1 outlines the baseline clinicalcharacteristics of the study patients. Seven of 19 (37%) weremale. The mean age was 75 � 11 years for the mitralpatients and 42 � 24 years for the tricuspid patients. Threeof the 10 tricuspid valve implant patients were �18 years ofage. Median age of the dysfunctional valve was 6 (4 to 11)years. The size of the dysfunctional valve outer sewing ringranged from 27 to 29 mm for the mitral valve patients andfrom 25 to 33 mm for the tricuspid valve patients. Measuredinternal diameter of the dysfunctional valve was 18 to 22mm in the mitral patients by TEE and 17 to 23 mm in thetricuspid patients by balloon sizing. According to themanufacturers’ specifications, the reported internal diameterof the dysfunctional valves was 24 to 28 mm in the mitralpatients and 20.5 to 31 mm in the tricuspid patients. MeanSTS risk score for mortality risk in the mitral valve patientswas 13.3 � 5.6%. Despite high surgical risk, 2 of the 9mitral patients and 4 of the 10 tricuspid patients werepotentially candidates for either percutaneous valve-in-valveimplantation or open surgical repair. After a multidisci-plinary “heart team” discussion, the patients elected thepercutaneous procedure. The other 7 mitral and 6 tricuspidcases were too high risk for conventional valve surgery and

Figure 2. Tricuspid Valve Implantation

(A) A 3-dimensional transesophageal echocardiography (TEE) image of a severely degenerated tricuspid bioprosthetic valve with destruction of the septal leafletand poor leaflet coaptation. (B) Severe tricuspid regurgitation on pre-procedure 2-dimensional TEE. (C) A fluoroscopic image of Melody valve deployment insidea dysfunctional bioprosthetic valve. (D) A 3-dimensional TEE image from a ventricular view of the Melody valve aligning with the prosthetic valve struts.(E) Trivial post-procedure tricuspid regurgitation on 2-dimensional TEE. (F) The deployed Melody valve on 3-dimensional TEE.



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underwent percutaneous valve-in-valve replacement as analternative to medical therapy alone. Four of the 10 tricuspidvalve patients had congenital heart disease, including 3 withEbstein’s anomaly and 1 with pulmonary valve stenosis andtricuspid valve dysplasia. Three of the 10 tricuspid patientshad significant ascites.

At baseline, mean diastolic inflow gradient was 12.3 �4.6 mm Hg among the mitral patients. Seven of the 9 mitralpatients had moderate or worse bioprosthetic mitral valveregurgitation. Mean baseline diastolic inflow gradient was10 � 4.3 mm Hg among the tricuspid patients. Seven of the10 tricuspid patients had moderate or worse tricuspid valveregurgitation (Table 2).Procedures. All patients underwent successful implantationof a 22-mm Melody valve into the existing dysfunctionalbioprosthetic valve. Table 3 displays the procedure charac-teristics according to valve-in-valve implantation position.

No periprocedural death, myocardial infarction, stroke,stent fracture, or valve embolization occurred in either themitral or tricuspid patients. Vascular complications occurredin 4 patients. These included a right iliac artery dissectiontreated endovascularly, a right thigh hematoma treatedendovascularly, a left femoral artery pseudoaneurysm treatedsurgically, and bleeding at the femoral access site thatresponded to conservative therapy. Two patients developeda left hemothorax requiring chest tube draining, likely

related to the left ventricular apical puncture. One mitralvalve patient required closure of the transseptal puncture sitewith an Amplatzer septal occluder (St. Jude Medical) due tosignificant bidirectional shunting across the transseptalpuncture site.Hemodynamic outcomes. Mean diastolic inflow gradientdecreased from 12.3� 4.6 mmHg to 5.2� 2 mmHg for themitral valve patients (Fig. 3B) (p < 0.01) and from 10 � 4.3mm Hg to 5.6 � 2.5 mm Hg for the tricuspid valve implants(Fig. 3B) (p < 0.01). Degree of valve regurgitation improvedafter valve-in-valve implantation. In the mitral valve patients,post-procedure regurgitation was undetectable in 2 patients,trivial in 2 patients, mild in 2 patients, mild to moderate in 2patients, and moderate in 1 patient (Table 2). In the tricuspidvalve patients, post-procedure regurgitation was trivial in 5patients, mild in 4 patients, and mild to moderate in 1 patient(Table 2).Early outcomes. No patients died during hospitalization.Median duration of hospitalization was 5 (1 to 14) days forall patients, 9 (5 to 15) days for the mitral valve patients, and2 (1 to 9) days for the tricuspid valve patients.

Median follow-up was 41 (11 to 209) days for all patients.Three tricuspid valve patients were readmitted within30 days of their procedure: 1 patient had a femoral arterypseudoaneurysm requiring surgical repair and 1 patient hadfever due to phlebitis. An 11-year-old congenital patient

Table 1. Baseline Clinical and Echocardiographic Characteristics

Patient#*

Age(Years) Sex

DysfunctionalValve Position

ValveSize (mm)

ValveType

Valveage (yrs)

LVEF (%)y

STS MortalityScore (%)

Number ofPrevious

Sternotomies

PreviousCoronary

Revascularization

1 85 M Mitral 27 d 8 62 23.8 2 Yes

2 70 F Mitral d d 9 41 8.1 1 Yes

3 88 M Mitral d d 10 63 19.0 1 No

4 84 M Mitral 27 Carpentier-Edwards 6 30 10.9 1 Yes

5 83 M Mitral 29 Carpentier-Edwards 11 30 14.1 2 No

6 75 F Mitral 29 Carpentier-Edwards 17 69 6.0 1 No

7 65 F Mitral 27 St. Jude porcine 2 65 10.9 3 No

8 57 F Mitral 27 Baxter-Edwards 14 25 11.0 1 No

9 66 F Mitral 27 Medtronic Mosaic 4 65 16.2 1 Yes

10 17 F Tricuspid 25 Medtronic Mosaic 7 30 d 4 No

11 12 F Tricuspid 25 St. Jude Biocor 5 63 d 2 No

12 58 F Tricuspid 33 Carpentier-Edwards 11 65 d 1 No

13 72 F Tricuspid 33 Carpentier-Edwards 6 35 d 2 No

14 76 M Tricuspid 27 Medtronic Mosaic 5 60 d 3 Yes

15 10 M Tricuspid 25 St. Jude porcine 2 65 d 1 No

16 50 F Tricuspid 29 Baxter-Edwards 6 57 d 1 No

17 30 F Tricuspid 31 St. Jude porcine 2 55 d 2 No

18 59 F Tricuspid 20 Medtronic Mosaic 5 67 d 1 No

19 38 M Tricuspid d Hancock porcine 26 33 d 3 No

*Patients are listed in chronological order of procedure, according to dysfunctional valve position. yData from pre-procedure transthoracic echocardiogram.

LV EF ¼ left ventricular ejection fraction; STS ¼ Society of Thoracic Surgeons.

Table 2. Pre-Implant and Post-Implant Functional Status and Hemodynamic Characteristics

Patient#

DysfunctionalValve Position

NYHA FunctionalClassification

DiastolicGradient (mm Hg)

ProstheticRegurgitation

Right AtrialPressure (mm Hg)

Pre-Implant Post-Implant Pre-Implant* Post-Implanty Pre-Implant* Post-Implanty Pre-Implant* Post-Implanty

1 Mitral 4 3 15 5 Moderate Trivial d d

2 Mitral 3 2 12 4 Moderate–severe Mild–moderate d d

3 Mitral 4 3 9 9 Moderate–severe Mild d d

4 Mitral 3 2 14 3 Moderate–severe None d d

5 Mitral 3 4x 17 5 Mild–moderate None d d

6 Mitral 3 1 9 4 Severe Trivial d d

7 Mitral 3 2 10z 8 Severez Moderatez d d

8 Mitral 4 2 20 5 None Mild d d

9 Mitral 4 2 5 4 Severe Mild–moderate d d

10 Tricuspid 2 1 9 3 Severe Trivial 13 11

11 Tricuspid 2 1 12 8 Severe Mild 16 12

12 Tricuspid 4 2 20 7 Trivial Trivial 23 21

13 Tricuspid 3 1 7 4 Severe Mild–moderate 21 18

14 Tricuspid 3 1 9 9 Mild Trivial 20 20

15 Tricuspid 2 4k 7 6 Severe Trivial 14 9

16 Tricuspid 4 2 12 4z Mild–moderatez Trivialz 29 29

17 Tricuspid 3 1 7 2z Severe Mildz 18 16

18 Tricuspid 4 3 5 4 Severe Mild 21 30

19 Tricuspid 1 1 12 9 Severe Mild 17 d

*Data from pre-procedure transthoracic echocardiogram, unless indicated. yData from post-procedure transthoracic echocardiogram, unless indicated. zData from pre- or post-procedure transesophageal

echocardiogram. xThis patient was dismissed to palliative care 20 days after his valve-in-valve implantation. kThis patient suffered from hyperacute Melody valve failure due to valve thrombosis. He

underwent right-ventricular assist device placement 19 days after his valve-in-valve implantation and surgical tricuspid valve replacement 5 days later. For the purposes of calculating his functional status

after valve-in-valve implantation, surveillance was truncated at the time of his Melody valve failure.

NYHA ¼ New York Heart Association.



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Table 3. Procedure Characteristics

MitralImplantation Cases

TricuspidImplantation Cases

Procedure time, min 211 � 72 175 � 39

Fluoroscopy time, min 37.2 � 8.5 21 (15–33)

Contrast use, ml 92 � 79 40 � 42

Radiation dose, mGy 1,028 � 610 791 (298–1,566)

Radiation dose, Gy $ cm2 94 � 58 73 (31–157)

Values are mean � SD or median (interquartile range).



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with previous early bioprosthetic failure experienced Melodyvalve thrombosis 18 days after his procedure. He requiredsurgical tricuspid valve re-replacement with a homograftvalve. Pathological examination of the excised Melody valverevealed an occlusive thrombus. Despite anticoagulation,acute failure of the homograft tricuspid prosthesis occurredwithin a few days of redo surgical tricuspid valve replace-ment. Thrombophilia evaluation revealed heparin-inducedthrombocytopenia. The patient was listed for cardiactransplantation and remains clinically stable despite bio-prosthetic valve stenosis.

One mitral patient died of unknown causes 110 days afterhis valve-in-valve procedure. At the time of this patient’s lastclinical contact with our institution, he had New York HeartAssociation (NYHA) functional class III symptoms, onlya slight improvement from his pre-operative status. Asecond mitral valve patient was dismissed to palliative caredue to persistent severe heart failure. He died the day afterhospital dismissal. A third mitral valve patient died ofunknown causes 19 days after her valve-in-valve procedureand 12 days after hospital discharge. At the time of her lastcontact with our institution, she reported NYHA functionalclass II symptoms. Overall, NYHA functional classimproved in 8 of the 9 mitral valve patients and 9 of the10 tricuspid valve patients (Fig. 3A) (p < 0.01).

Figure 3. Change in NYHA Functional Class and Diastolic Inflow Gradient

(A) The change in New York Heart Association (NYHA) functional classification for theundergoing mitral (n ¼ 9) and tricuspid (n ¼ 10) valve-in-valve implantation.

Discussion

The present study demonstrates the feasibility and clinicalefficacy of percutaneous, transvenous valve-in-valve implan-tation of the Melody valve for treatment of dysfunctionalbioprosthetic mitral and tricuspid valves. This series describesa novel transvenous, transseptal technique utilizing an apicalrail to facilitate mitral valve-in-valve implantation. Percuta-neous transvenous Melody valve implantation reduced inflowobstruction and prosthetic valve regurgitation. In themajority of patients, it improved clinical symptoms. Theprocedure was safe and well tolerated, with no periproceduralmortality. These findings support an emerging role forpercutaneous, transvenous implantation of the Melody valvein patients with dysfunctional bioprosthetic mitral ortricuspid valves in which repeat sternotomy and open cardiacsurgery carry substantial perioperative risk.

The Melody valve has an established role in the treatmentof right-sided compared with left-sided valvular disease(18,27). Previous studies have suggested adequate perfor-mance under systemic pressures or in the setting ofpulmonary hypertension (28). Our series adds to theprevious literature supporting the feasibility of Melody valveimplantation in higher pressure environments.

Other series of patients undergoing transcatheter valve-in-valve implantation have used the Edwards Sapien valve(Edwards Lifesciences, Irvine, California) (5,6,8). We chosethe Melody valve for several reasons. The Melody valve islonger in length than the Edwards Sapien valve (29), facil-itating coaxial alignment. The longer length of the Melodyvalve also allows it to cover the entire dysfunctional bio-prosthetic valve, so stenting the deployment site beforeimplantation is not necessary. At the time of our firstprocedures, the Melody valve was the only transcathetervalve available for off-label use in the United States. Finally,the Melody valve provided a favorable size profile for our

19 patients in this study. (B) Change in diastolic inflow gradient for the patients



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patients. Although the reported internal diameter of thedysfunctional bioprosthetic valves in our series was as high as31 mm, the measured internal diameter ranged from 17 to23 mm. This decrease in size reflects degeneration of thedysfunctional prostheses. The Melody valve, by contrast,expands up to 24.06 mm, with a small percentage of recoilon the 22-mm Ensemble delivery system (30). Therefore,the Melody valve provided an appropriate size profile to fitthe measured internal diameters of the dysfunctional bio-prosthetic valves in our series.

The first reported attempt at mitral valve-in-valveimplantation was unsuccessful due to an inability to align thepercutaneous valve in a coaxial position with the dysfunc-tional bioprosthetic valve (4). Other series have overcomethis problem through implantation via a transapicalapproach (5,6,8). Our approach uses a continuous rail fromthe femoral vein, through the atrial septum, with exterior-ization via the left ventricular apex. This facilitates coaxialalignment of the percutaneous Melody valve with thedysfunctional bioprosthetic valve, allows delivery from thevenous side, and minimizes the sheath size necessary toaccess the left ventricle. In this series, our approach did notresult in any cases of valve embolization, poor valve align-ment, or dysfunction of the Melody valves placed in themitral position.

Vascular complications occurred in 4 of 19 patients (21%)in our series. All 4 vascular complications occurred on theside of the venous sheath that we used for Melody valvedelivery. In 3 of the 4 cases, we also obtained arterial accessat the same site. It is likely that these vascular complicationswere related to the large size of the venous sheath used forMelody valve delivery, concurrent arterial access, and patientcomorbidities.

The left ventricular puncture carries established risks, withcomplication rates documented as high as 30% to 40%(22,31). In our series, 2 of 9 patients (22%) undergoingmitral valve-in-valve implantation developed a left hemo-thorax requiring chest tube drainage. No patients developedpericardial tamponade, arrhythmias, or persistent painrelated to the left ventricular apical puncture. Therefore,despite its risks, use of a left ventricular apical puncture aspart of the mitral valve-in-valve implantation procedureseems an acceptable method to facilitate alignment of thepercutaneous valve.

Difficulty obtaining adequate coaxial alignment alsooccurs during tricuspid valve-in-valve implantation. Someauthors have advocated an open transthoracic procedure tofacilitate alignment (4,32,33). However, our series demon-strates that adequate alignment can occur through eithera transfemoral or transjugular approach and use of a rela-tively flexible support wire.

Our patients undergoing mitral valve-in-valve implanta-tion were elderly and ill, with multiple comorbid conditionsand a mean STS mortality score of 13.3%. This is similar to

patients in other valve-in-valve series (4–6,8). Despite theirhigh risk, patients tolerated the procedure well. Neverthe-less, valve-in-valve therapy should be reserved for patientswhose surgical risk and comorbid medical conditions wouldpreclude surgical valve intervention.

Our group of 10 patients undergoing Melody valveimplantation in the tricuspid position included a hetero-geneous range of pathology. The youngest 4 patients inour group all had a history of congenital heart diseaserequiring prior tricuspid valve replacement. The 6 olderpatients underwent their initial tricuspid valve replacementfor tricuspid valve endocarditis in 1 case, carcinoid heartdisease in 1 case, rheumatic heart disease in 1 case, andpresumed functional tricuspid regurgitation in the other 3cases. Previous reports describing tricuspid valve-in-valvetherapy have occurred in a similarly heterogeneous pop-ulation, including children with congenital heart disease(20,21,34), adults with congenital heart disease (21,35,36),patients with prior infective endocarditis (21,37), andpatients with a history of rheumatic (21,33,38) or carci-noid (32) heart disease. The success of the procedure inour study group coupled with the positive outcomes fromprior reports suggest that tricuspid valve-in-valve therapyhas the potential to benefit patients with a variety ofmedical conditions leading to bioprosthetic tricuspid valvefailure.

All patients in our series had the benefit of intraproceduralimaging with TEE (n ¼ 12) or ICE (n ¼ 7). Imagingsupport facilitated Melody valve sizing, Melody valvealignment, and assessment of valve-in-valve functionimmediately after implantation. We found 3-dimensionalechocardiography particularly useful for the assessment ofdysfunctional bioprosthetic valve morphology prior to valve-in-valve implantation (Figs. 1A and 2A) and Melody valvegeometry after the procedure (Figs. 1E and 2F).Study limitations. This is a single-institution, retrospectivereview of patient records after percutaneous valve-in-valveimplantation of the Melody valve in the mitral or tricuspidposition. Patients were highly selected. Post-procedure caremay not have occurred at our institution, potentially limitingour ability to capture all post-procedural events. Finally,the immediate success of valve-in-valve implantation atimproving hemodynamics and patient symptoms may notnecessarily predict long-term outcomes. Study of largercohorts with prolonged surveillance will be necessary toaddress this question. These will become possible as valve-in-valve technology and implantation techniques mature.

Conclusions

We report a series of 19 patients undergoing percutaneoustransvenous Melody valve-in-valve implantation for treat-ment of dysfunctional bioprosthetic mitral or tricuspidvalves. We also describe a novel technical approach utilizing



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an apical rail to facilitate mitral valve-in-valve implantation.Procedures were well tolerated and resulted in improvedvalve function and heart failure symptoms. Longer surveil-lance and larger cohorts are necessary to determine theultimate role of percutaneous valve-in-valve implantation indegenerated bioprosthetic valves.

Reprint requests and correspondence: Dr. Charanjit S. Rihal,Division of Cardiovascular Diseases, Department of InternalMedicine, Mayo Clinic, 200 First Street SW, Rochester, Minne-sota 55905. E-mail: [email protected].

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Key Words: bioprosthetic valve - mitral stenosis - percu-taneous valve - tricuspid stenosis - valve-in-valve.

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