10 Zig Covered CP CCP in Leuven 

patient initials age Pt  weight  date implant  location indication length stent delivery sheath flairing  

y kg mm balloon  F balloon 

1 VD 43 78 17‐10‐2003 distal Ao cross dilate, exclude aneurysm 60 18 BIB 14 25

2 SR 42 86 26‐6‐2012 TriV CE  protect ICD lead in TriV‐CE 39 32 BIB 24 Sapien ‐

3 VJ 52 104 3‐10‐2014 RVOT expand homograft beyond nominal 55 20 BIB  14 23

4 ST 17 46 14‐2‐2017 RVOT reduce stent to fit Sapien 29 45 30 Andra 16

5 VJ 30 52 3‐4‐2017 TCPC conduit seal ruptured conduit at 24 mm 55 24 14

6 ‐ ‐ ‐ ‐ ‐ safety: emergency sealing  45 on shelf on shelf on shelf 

Patient 1 (2003) Problem: seal post‐op coarctectomy aneurysm with wide origin at Left subclavian artery LSA en istmus Use of 60 mm 10 zig CCP stent  to allow dilation up to 24 mm with good sealing; perfect result with now 13 years of FU.  Published in European Heart Journal 2004 (front‐page & case report) 

   

        

Patient 2 (2012) Problem= 33 mm Carpentier –Edwards TriV; ICD lead through TriV Patient was considered “inoperable” in USA after 5 surgeries ; ICD lead not transferable Percutaneous TriV was offered, but sharp edges of Sapien valved stent could damage insulation of ICD lead Solution: protect ICD lead first with “atraumatic” 10 zig 39 mm CCP stent on 32 mm BIB in 33 mm CE valve   Published in CCI 84:1148–1152 (2014)   CCP stent advanced through right atrium towards CE‐TriV  

  CCP stent post dilated  

       

CCP stent in position within CE‐TriV 

  Final result: 26 mm Sapien in CCP stent in CE‐TriV  

  Follow –up: perfect function TriV, no paravalvar leak, no lead failure of ICD lead.   

    

Patient 3 Problem: PO Ross wit homograft in RVOT Homograft had shrunken – stenosis Reason 10 zig CCP stent: to open –expand homograft safely with 1 stent from just proximal of ventricular junction until the bifurcation (to avoid multiple covered stents in series)  Stenotic homograft 

  10 zig 55 mm CCP stent on  20 mm BIB through 14 F sheath  

        

55 mm stent after delivery in homograft, before expansion  

    

     

After additional CP 65 mm on 24 mm BIB, then Sapien 26 mm  in RVOT  

  

  

  

Patient 4  PO Tetralogy of Fallot with transannular patch Dilation of RVOT up to 29 mm First implantation of  57 mm Andrastent XXL at 30 mm;  PPVI was planned with Sapien 29 mm, but landing zone of 30 mm borderline large, and risk for paravalvar leak was significant (landing zone no more than 3 mm long) 

   57 mm Andrastent at 30 mm  

     

Lengthen landing zone from 3 mm to 45 mm, reduce diameter to allow 30 mm Sapien to fit   

  Final result: Sapien 29 in45 mm CCP stent in 57 mm Andrastent XXL at 30 mm   

      

Patient 5 PO Fontan TCPC with 16 mm Gore‐Tex conduit R: stent expansion of conduit up to 20 with ANdrasten XXL; rupture of conduit with leak to atrium and pericardium R/ a 8 zig 45mm was too short; additional 10 zig 55 mm zig CCP stent solved the problem  16 mm TCPC conduit  in TCPC Fontan  patient  

  Rupture of conduit after expansion up to 20 mm 

     

Attempt to close with 8Z45 mm: still residual leak  

   Additional 10 zig 55 CCP stent solves the problem (longer, less shortening) 

             

  10 zig 55 CCP stent deployed: no more extravasation   

       Patient 6 

Our most important stent: still on the shelf 

For emergency bail‐out stenting if vascular rupture with extravasation occurs 

Allows us to treat other patients safely until the edge  for optimal result; if tear or rupture, this stent will solve the problem within seconds (much faster than any surgeon can do) 

Elective use if o Covering in stent size > 22‐24 mm required o Long stent needed allowing only limited shortening o To avoid multiple covered stents in series (= more expensive, more complex, 

more risk for leak, more risk embolisation, more dangerous, more complications, longer procedure, more radiation, more contrast ) 

    Marc Gewillig, MD, PhD, FESC, FACC, FAEPC  Pediatric Cardiology Leuven B 3000 Leuven, Belgium Marc.gewillig@uzleuven.be   

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31/07/2004http://www.escardiocontent.org/webfiles/images/journals/yeuhj/25-14lg.jpg

Case Reports

Transvenous Valve-in-Valve Replacement Preservingthe Function of a Transvalvular Defibrillator Lead

Pieter De Meester,1 MD, Werner Budts,1 MD, PhD, and Marc Gewillig,2* MD, PhD

Although feasibility and efficacy of percutaneous tricuspid valve-in-valve implantationhave been established, a transtricuspid pacing or defibrillator lead might preclude thistechnique: lead damage can cause lead dysfunction resulting in inappropriate or ineffi-cient pacing or shocks. In these cases, lead removal is thought to be the only option.We describe a patient who presented with rapid clinical deterioration due to tricuspidvalve stenosis early after implantation of an internal defibrillator with a transvalvularshock-lead. A transvenous valve-in-valve implantation of the tricuspid valve was per-formed after protecting the defibrillator-lead with a custom-made covered stent. Wedescribe the technical issues, the clinical outcome, and the evolution of lead functionafter implantation. VC 2014 Wiley Periodicals, Inc.

Key words: tricuspid valve; percutaneous intervention; internal cardiac defibrillator;lead protection

INTRODUCTION

In patients at high risk for cardiac surgery, feasibilityand efficacy of percutaneous tricuspid valve-in-valveimplantation have been established [1–3]. However,patients with a transtricuspid pacing or defibrillatorlead challenge the interventional cardiologist with a di-lemma: the valved stent can damage the lead causingdysfunction, inadequate sensing or pacing, which inturn may result in delivering inappropriate or ineffi-cient shocks [4,5].

We describe a patient who presented with sympto-matic tricuspid valve stenosis after implantation of atransvalvular shock-lead. A transvenous valve-in-valveimplantation of the tricuspid valve was performed afterprotecting the defibrillator lead with a covered stent.

CASE REPORT

A 42-year-old male presented for percutaneous reval-vulation of the tricuspid valve. He was born with an arte-rial trunc, underwent pulmonary artery banding ininfancy, and was repaired at the age of five. Later, multi-ple re-interventions were needed. At the age of 29 years,right ventricular outflow tract reconstruction with aCarpentier-Edwards size 27 mm bioprosthesis, as well asimplantation of a tricuspid valve Carpentier-Edwards size

33 mm bioprosthesis was performed. Symptomatic runsof ventricular tachycardia at the age of 40 years weretreated with an internal defibrillator (ICD) Medtronic Vir-tuosoVR VR connected to a 9 Fr transvalvular shock lead(Medtronic 6947).

In the years following ICD implantation, tricuspidvalve stenosis developed with rapid clinical deteriorationin 2 years. He presented now in NYHA functional classIV with severe right heart failure and anasarc edema.

1Department of Congenital Cardiology, University HospitalsLeuven, Leuven, Belgium2Department of Pediatric Cardiology, University HospitalsLeuven, Leuven, Belgium

Conflict of interest: MG is proctor for NUMED and Edwards.

Contract grant sponsor: Agency for innovation by Science and

Technology in Flanders (IWT).

*Correspondence to: Marc Gewillig MD, PhD, Pediatric Cardiology,

University Hospitals Leuven, Herestraat 49, B-3000 Leuven,

Belgium. E-mail: marc.gewillig@uzleuven.be

Received 7 October 2013; Revision accepted 16 February 2014

DOI: 10.1002/ccd.25451

Published online 19 February 2014 in Wiley Online Library

(wileyonlinelibrary.com)

VC 2014 Wiley Periodicals, Inc.

Catheterization and Cardiovascular Interventions 84:1148–1152 (2014)

Doppler echocardiography revealed severe tricuspidvalve stenosis with a mean transvalvular gradient of 20mm Hg at 75 bpm heart rate. Right ventricular functionwas severely impaired. Moderate dysfunction of theleft ventricle (ejection fraction¼ 45%) was present.Signs of increased right atrial pressure with severe dil-atation of the right atrium and a dilated inferior venacava without respiratory variation were noted.

The patient was refused for surgery by a leadingcenter for cardiovascular surgery because of the highoperative risk after five previous sternotomies, the lastone being complicated by bleeding and difficult chestclosure. Therefore, a transvenous valve-in-valve im-plantation in the tricuspid position seemed a better al-ternative. The patient declined percutaneous removal ofthe defibrillator lead with replacement by anepicardial-subcutaneous lead system. As valved stentscould damage complex electrical leads, we chose toprotect the defibrillator lead by means of a custom-made Expanded polytetrafluoroethylene (ePTFE) cov-ered stent before implantation of the valved stent.

BENCH TESTING AND CLINICAL PROCEDURE

Before the procedure was performed, we did benchtesting of the implantation technique used. A 39 mm 8Zig Covered CP stentTM (NuMEDVR , NY) was mountedon a 28 mm balloon (NuMEDVR ) to protect the 9 FrICD wire crossing a 33 mm Carpentier Edwards bio-prosthesis (Fig. 1). Next an Edwards SAPIEN XT 29mm valve was implanted in the covered stent. It shouldbe noted that the 8 Zig stent foreshortens significantlywhen it is dilated beyond 23 mm (70% at 26 mm).Furthermore, the ePTFE membrane may tear whendilated beyond 24 mm. Therefore, when performingthe clinical intervention, we chose a 10 Zig CCP stent(custom made, no CE mark; NuMEDVR ) which can bedilated up to 36 mm with significantly less foreshorten-ing (20% at 26 mm) while the ePTFE membraneremains intact.

The patient was anesthetized with endotracheal intu-bation and artificial ventilation. Veno-arterial extracor-poreal membrane oxygenation circulation (ECMO)with femoral access was started as a safety measure at4 l/min to give hemodynamic support during the proce-dure: we felt that because of the poor clinical status,the patient would not tolerate the hemodynamic conse-quences of leaving the tricuspid valve temporarystented open during the procedure. Percutaneous accesswas obtained by inserting a 9–24 Fr sheath in the rightjugular vein using a dilator kit.

First, right heart catheterization during minimal flowECMO confirmed severe tricuspid valve stenosis witha mean transtricuspid gradient of 20 mm Hg at 80 bpmheart rate, despite low output (Fig. 2).

After balloon interrogation of the inner diameter (25mm), the defibrillator lead was protected with a custommade 39 mm 10 Zig Covered CP stentTM (NuMEDVR )mounted on a 32 mm Balloon-in-Balloon catheter(NuMEDVR ) (Fig. 3A). Next, a 26 mm EdwardsSAPIEN valve (9000 TFX 26) was deployed in the tri-cuspid position (Fig. 3B)

Fig. 1. Bench testing of percutaneous valve-in-valve replace-ment of the tricuspid valve. A 39 mm 8 Zig Covered CPstentTM (NuMEDVR , NY, USA) was positioned into the 33 mmCarpentier Edwards bioprosthesis. The 9 Fr defibrillator leadis protected as it passes between the CE ring and the newlypositioned CCP stent.

Fig. 2. Hemodynamic evaluation of the tricuspid valve steno-sis pre- and post-intervention. RA indicates right atrium;RV 5 right ventricle.

ICD Lead Function at Revalvulation 1149

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

RESULT AND FOLLOW-UP

Valvular function improved dramatically with an

invasive transtricuspid gradient of 6 mm Hg at

91 bpm heart rate post-procedure and only minimal

valvular regurgitation (Fig. 2). Tricuspid valve func-

tion was preserved at 13-months follow-up without

echocardiographic evidence of restenosis or valvular

regurgitation.Before and after the procedure, ICD lead impedan-

ces and function were evaluated (Table I). Immediately

after the procedure, lead impedances lowered. In the

follow-up, no further decline was noted.During a 13-months follow-up, the patient had two

appropriate ICD interventions due to ventricular tachy-

cardia, reconverted by anti-tachypacing. He had ven-

tricular pacing for 20% of the time. No inappropriate

shocks were fired. Impedance as well as the pacingthresholds remained stable (Table I).

Because of the decrease in impedance, the effect oflead crushing was tested ex vivo. Shock leads weretested in a saline solution to reproduce the osmolalityof the blood and a sponge placed in the saline solutionto mimic human tissue contact. Impedance measure-ments of a Medtronic 6947 defibrillator lead connectedto a Medtronic MaximoVR VR 7232 ICD was measuredat baseline. Next, the lead was crushed at 15 atmbetween a 29 mm Sapien stented valve within a cov-ered CP stent, and the ring of a 33 mm CarpentierEdwards bioprosthesis. The results of impedance test-ing can be found in Table II.

A Medtronic 6947 lead that had been crushedbetween the stents and the valvular ring for 17 monthswas connected to the same device. Impedance testing

TABLE I. Evolution of Lead-Impedances Pre- and Post-Intervention in the Patient

Date

Pacing

impedance

RV defib

impedance

SVC defib

impedance

RV pacing

threshold

Baseline 480 X 49 X 61 X 0.5V at 0.4 msec

Post-procedure (% compared to baseline) 392 X (82%) 25 X (51%) 33 X (54%) 1.0 V at 0.4 msec

Day 2 (% compared to baseline) 368 X (75%) 25 X (51%) 33 X (54%) 1.0 V at 0.4 msec

13 months (% compared to baseline) 336 X (70%) 28 X (57%) 37 X (60%) 1.0 V at 0.4 msec

Fig. 3. Angiographic images during intervention showing (A) status after deployment of thecovered CP stent excluding the defibrillator lead outside the annulus and (B) status afterdeployment of the Edwards SAPIEN valve.

1150 De Meester et al.

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

was performed and again after release of the pressureby the stents (Table II).

Superior vena cava (SVC) and right ventricular (RV)impedances were rather low in the test conditions.However, no significant changes could be observed inSVC impedance and RV shock impedance during ei-ther active crushing of the lead and after deflation ofthe balloon. Release of the lead after 17 months didnot alter the impedance.

DISCUSSION

Stenosis of a tricuspid bioprosthetic valve is com-mon after 13 years although accelerated dysfunction af-ter lead implantation is sometimes reported [6,7].When a transvalvular lead is present and a new valveneeds to be implanted, several approaches can be con-sidered.

A surgical tricuspid valve intervention allows thelead to be extracted and replaced by a transvenousextra-annular or epicardial-subcutaneous lead system;however, because of previous multiple complicatedsternotomies the risk in this patient was deemed exces-sively high. A percutaneous approach offers twooptions. First, lead extraction with subsequent epicar-dial sensing-pacing and subcutaneous shock lead place-ment could be followed by percutaneous revalvulationof the tricuspid valve. However, percutaneous leadextraction is difficult and is associated with significantmorbidity and mortality [8]. Additional risk factors forlead extraction are severe fibrosis and the use of ascrew-in lead, which were both present in this patient[8]. Furthermore, the patient refused percutaneous leadextraction and the significant cardiomegaly raiseddoubt about epicardial sensing and pacing and adequatesubcutaneous shock function. Lastly, a new percutane-ous valved stent can sandwich the lead between the oldbioprosthesis and the new, valved stent.

The Edwards Sapien valve has a stiff stent withsharp edges, designed to anchor well into the calcifiedaortic valve ring. When placed in the tricuspid posi-tion, it could cause lead malfunction either by damag-ing the insulation causing a short circuit, dysfunctionof sensing or (sub-) total lead fracture with failure of

pacing and defibrillator therapy. Therefore, we choseto protect the lead with a covered CP stentTM. Thisstent consists of relatively thick (0.01300) rounded wirethat is little abrasive to the surrounding tissue. To fur-ther reduce the local stress as well as to reduce a possi-ble paravalvular leak after stent and valve placement,we chose an ePTFE covered stent. The Carpentier-Edwards 33 mm bioprosthesis has a profile height of25 mm and the Edwards Sapien valve has a frameheight of 16.1 mm. Therefore, we implanted a 10 Zigcovered stent in this patient, which can be dilated upto 36 mm with its ePTFE membrane remaining intact.Only minimal foreshortening occurs when it is dilatedless than 30 mm. After stent placement, the 26 mmEdwards Sapien valve could be easily deployed inappropriate position.

No complications occurred; rapid improvement of ve-nous congestion, right heart failure, and exercise toler-ance were noted. Lead impedances immediately afterprocedure lowered, probably due to local stress onthe lead; the lead-resistance remained stable duringfollow-up. At 13 months, pacing function was preservedand correct detection of ventricular tachycardia withappropriate delivery of anti-tachypacing was noted. Thepatient did not receive inappropriate shocks. As the evo-lution is unpredictable, the patient was instructed tohave a magnet available to reset the device into VOOwhen inappropriate shocks would be fired.

A decrease in lead impedance is most often causedby damage of the insulation, either by mechanical dis-ruption or by degradation and metal ion oxidation [4].The leads have a multilumen design with a siliconeinsulation of each conductor individually to withstandmechanical stress and lead degradation. Althoughbench testing could not identify changes in impedancesby actively crushing the lead, or after long-term pres-ence of the lead sandwiched between the valvular ringand the stents, changes in SVC and RV impedancescould be seen in our clinical case immediately post-intervention. Disruption of the insulation could haveoccurred; however, if the cardiac motion would causemechanical disruption of the lead, further decline inlead impedances should have occurred in follow-up.Furthermore, as the lead was already implanted for

TABLE II. Bench Testing of Lead-Impedances in Tested Conditions

Measured

impedance

New lead

Lead 17 months placed between

stent and homograft ring

Free (X)

Balloon inflated to

15-atmosphere (X)

Placed between stent and

homograft ring (X)

17 months in

place (X)

After

release (X)

RV pacing 1,984 1,904 1,744 576 576

RV Defib 26 26 25 20 20

SVC Defib 31 31 31 26 23

ICD Lead Function at Revalvulation 1151

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

2 years, silicone stiffening and ion diffusion into thelead insulation could cause a low-resistance circuitbetween conductors after crushing. We could not repro-duce these conditions in our ex vivo experiment.Lastly, an altered orientation of the lead closer to theRV free wall or changes in volume-status after the pro-cedure could have influenced lead impedances [9,10].It should be noted that, although impedances lowered,values remained on the safe side.

CONCLUSION

This case shows an alternative approach when con-fronted with patients with a transvalvular lead and theindication for percutaneous tricuspid valve replace-ment. Exclusion of the lead outside the valvular ring isfeasible and efficient.

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