ulmonary Valve Implantation With the Newhelhigh Injectable Stented Pulmonic Valve
tefano M. Marianeschi, MD, Francesco Santoro, MD, Elena Ribera, MD,manuele Catena, MD, Gabriele Vignati, MD, Simone Ghiselli, MD,tefano Pedretti, MD, Ozkan Suleyman, MD, Hasim Ustunsoy, MD,nd Pascal A. Berdat, MDediatric Cardiology, Anesthesiology, MR Unit and Cardiac Surgery, Niguarda Hospital, Milan, Italy; Department ofardiovascular Surgery, Baskent University Hospital, Ankara, and Department of Cardiovascular Surgery, Gaziantep University
edical School, Gaziantep, Turkey; and Cardiovascular Center Zurich, Clinic Im Park, Zurich, Switzerland
�carefeeNl
wnft
Background. Pulmonary regurgitation (PR) occurs fre-uently after tetralogy of Fallot (TOF) repair, impairing
ong-term prognosis and necessitating reinterventions.yocardial damage, invasiveness, and the risks of pul-onary valve replacement (PVR) therefore need to beinimized. The new Shelhigh Injectable Stented Pul-onic Valve (Shelhigh Inc, Union, NJ) allows implanta-
ion without cardiopulmonary bypass (CPB) under directontrol.
Methods. Twelve symptomatic patients (age, 21.3 �2.5; range, 5.8 to 53.5 years) with severe PR and progres-ive right ventricular (RV) dilatation with dysfunctioneceived the Shelhigh valve in sizes 21 (n � 1), 25 (n � 4),7 (n � 3), 29 (n � 2), and 31 mm (n � 2).
Results. Valve insertion was successful and hemody-amic performance excellent in all: peak systolic gradi-
nt, 14.5 � 4.6 (range, 10 to 20) mm Hg; mean gradient, 6.3
vtscbPNts
P
Tpmt
fHi(via
ddress correspondence to Dr Marianeschi, Niguarda Hospital, Piazzaspedale Maggiore 3, 20162, Milan; e-mail: [email protected].
2008 by The Society of Thoracic Surgeonsublished by Elsevier Inc
ats.ctsnetjournDownloaded from
1.6 (range, 4 to 8) mm Hg. Four patients underwentoncomitant procedures on CPB: one reduction plasty of
dilated main pulmonary artery, two tricuspid valveepairs, and one VSD closure. Early recovery was un-ventful. There were no reoperations. During a meanollow-up of 5.4 � 4.3 months (range, 0.3 to 10.6 months)chocardiography showed good results, with low gradi-nts and recovered RV function in all. All presented inew York Heart Association functional class 1 at the
atest follow-up.Conclusions. The Shelhigh valve allows easy PVRithout CPB up to large valve sizes, with less invasive-ess compared with a conventional approach. Furtherollow-up is needed to assess its durability and long-erm performance.
ignificant pulmonary regurgitation (PR) is a commonproblem after surgical or percutaneous treatment of
ongenital cardiac defects such as pulmonary stenosis oretralogy of Fallot (TOF) [1]. Chronic volume overloadeads to significant late morbidity and death in a substan-ial number of patients due to progressive dilatation andysfunction of the right ventricle (RV), decrease in exer-ise tolerance, and malignant arrhythmias resulting inncreased risk of sudden death [2, 3]. Frequently, repeti-ive cardiac operations to treat recurrent right ventricularutflow tract (RVOT) obstruction and additional residual
esions such as ventricular septal defect (VSD), tricuspidegurgitation, or pulmonary branch stenosis further ad-ersely affect right and also left ventricular function [4, 5].Timely pulmonary valve replacement (PVR) with min-
mized invasiveness is therefore warranted. Despite theevelopment of percutaneous PVR, surgical PVR stillffers some advantages, including implantation of larger
ccepted for publication June 13, 2008.
resented at the Forty-fourth Annual Meeting of The Society of Thoracicurgeons, Fort Lauderdale, FL, Jan 28–30, 2008.
alve substitutes, no access limitations, and concomitantreatment of additional residual defects or sequelae. Inelected cases a hybrid approach of surgical PVR withoutardiopulmonary bypass (CPB) through sternotomy cane performed with the new Shelhigh Injectable Stentedulmonic Valve NR4000-PA MIS (Shelhigh Inc, Union,J). We report our multi-institutional experience with
he clinical use of this device in patients scheduled forurgical PVR.
atients and Methods
his study was approved and the need for individualatient consent waived by the institutional Ethics Com-ittee of the participating centers. Informed consent for
he operation was obtained from all patients.Between April 2007 and January 2008, 12 patients (4
rom Niguarda Hospital, Italy; 6 from Baskent Universityospital, Turkey; and 2 from Gaziantep University Med-
cal School, Turkey), with a mean age of 21.3 � 12.5 yearsrange, 5.8 to 53.5 years), received PVR with the Shelhighalve. Nine patients needed PVR after transannular ornfundibular patch, 2 after surgical valvuloplasty, and 1
fter balloon valvuloplasty. The mean interval between
1467Ann Thorac Surg MARIANESCHI ET AL2008;86:1466–72 INJECTABLE PULMONARY VALVE IMPLANTATION
AD
ULT
CA
RD
IAC
he initial repair and the actual operation was 18.9 � 9.8ears (range, 9.1 to 31.7 years).All patients presented with severe PR, progressive RV
ilatation, and impaired RV function. All patients wereymptomatic, presenting with either exercise intolerance,yspnea on exertion, chest pain, or a combination of
hose. Preoperative patient characteristics are presentedn Table 1. Patients were selected for hybrid PVR accord-ng to the inclusion/exclusion criteria presented in Table. Preoperative evaluation consisted of clinical examina-ion and echocardiography in all 12 patients. Preopera-ive magnetic resonance imaging (MRI) evaluation ofnatomic features and volumetric and flow dynamicndicators was done in the 4 patients from Italy, where
RI is available.Systolic and diastolic flow through the pulmonary
alve was quantified by velocity mapping allowing foralculation of pulmonary regurgitant fraction. RV mass,olumes, and function, as well as RVOT, and distalulmonary artery and aortic root anomalies (aneurysm,kinetic areas, fibrosis) were evaluated. We used anvanto 1.5-Tesla MRI (Siemens Healthcare, Malvern,A) aimed to obtain the best RVOT to pulmonary arteriesnatomic view and a precise ventricular volumetric andalvular flow dynamics definition (velocity encoding
able 1. Patient Characteristics
haracteristicsNo. (%) or Mean � SD
(range)
atients 12ge, y 21.3 � 12.5 (5.8–53,5)ody surface area, m2 1.5 � 0.4 (0.6–2.1)iagnosisTetralogy of Fallot 8 (66.7)Double-outlet RV 2 (16.7)Ebstein with pulmonary stenosis 1 (8.3)Isolated pulmonary stenosis 1 (8.3)
ime interval to previous repair, y 18.9 � 9.8 (9.1–31.7)V functiona 1.5 � 0.5 (1–2)VEF 0.653 � 0.087 (0.47–0.76)VEDVI, mL/m2 131.6 � 26.7 (95–155.2)VESVI, mL/m2 67.5 � 8.7 (56–75.9)VEF 0.473 � 0.114 (0.30–0.56)VSV, mL 113.5 � 41.7 (51–136)
RV function classified as normal � 0, mild impairment � 1, moderate �, severe � 3.
VEF � left ventricular ejection fraction; RV � Right ventricle;VEDVI � right ventricular end-diastolic volume index; RVEF �
ight ventricular ejection fraction; RVESVI: right ventricular end-ystolic volume index; RVSV � right ventricular systolic volume.
echnique was also used).tt
ats.ctsnetjournDownloaded from
evice Description and Implantation Techniqueevice description and technique of implantation havereviously been published [6]. In brief, the Shelhigh
njectable Stented Pulmonic Valve consists of a porcineulmonic valve inside a tube of bovine pericardiumounted on a self-expandable nitinol stent and is avail-
ble in size 17 to 31 mm (Fig 1). Through a medianternotomy, the RVOT and the main pulmonary arteryMPA) and its bifurcation are dissected free. The pul-
onic valve is inserted across 2 purse-string sutureslaced on the distal RVOT with the aid of a delivery
rocar system under direct digital control. To avoid mi-ration, several transmural sutures are used to secure thealve after deployment. After assessment of valve perfor-ance, the chest as closed in a routine fashion.In patients with a MPA of more than 29 mm, a
eduction plasty of the MPA should be considered tobtain at least 2 mm of oversizing of the largest valverosthesis (31 mm) available. Oversizing is consideredecessary to minimize the risk for paravalvular leakagend valve prosthetic migration. Reduction plasty is ac-omplished by a longitudinal polypropylene runninguture starting at the level of the bifurcation down to theVOT, reducing the external diameter to the desired size.eassessment of the shape of the RVOT, and measure-ents of the diameters at the level of the RVOT, the
ulmonary annulus, and the MPA by transesophagealchocardiography is essential to choose the correct size ofhe valve prosthesis after reduction plasty.
ollow-Uphe follow-up schedule was left at the discretion of theedical team in charge. Follow-up data were retrospec-
able 2. Patient Selection Criteria
nclusion criteriaThe patient requires an isolated pulmonary valvereplacement due to severe pulmonary regurgitation. Patientsneeding concomitant off-pump procedures, such aspacemaker procedures, RVOT, or PA plasty, are eligible.The patient has a MPA of � 13 mm and � 29 mm inmaximal diameter. Note, patients with a MPA of � 29 mmof maximal diameter are eligible but should undergoadditional surgical reduction procedures.The patient will be available to the investigators at theimplanting site for postoperative follow-up beyond 1 year.
xclusion criteriaThe patient has a stenosis of the RVOT, pulmonary valve, orMPA.The patient has a MPA of � 13 mm of maximal diameter orother anatomic condition prohibiting placement of theShelhigh Model NR-4000MI valve.The patient needs a concomitant procedure that requires theuse of CPB.The patient presents with active endocarditis within the last3 months.The patient is undergoing treatment for at least one of thefollowing pathologies: parathyroid disorder, calciumphosphate disorder, or renal insufficiency.The patient is a known drug or alcohol abuser.
PB � cardiopulmonary bypass; MPA � main pulmonary ar-
ery; PA � pulmonary artery; RVOT � right ventricular outflowract.
1468 MARIANESCHI ET AL Ann Thorac SurgINJECTABLE PULMONARY VALVE IMPLANTATION 2008;86:1466–72A
DU
LTC
AR
DIA
C
ively collected and analyzed. Two patients had MRItudies performed at 6 to 12 months postoperatively.
tatisticsata are expressed as the mean value � standard deviation
range). Percentages are given where appropriate. Statisti-al analysis was performed using Statview 5.0.1 softwareSAS Institute Inc, Cary, NC). For univariate analysis, the
ann-Whitney U test for continuous data and the �2 test forontingency tables for nominal data were used. A value of� 0.05 was determined statistically significant.
esults
atients received prosthetic valves in the following sizes:1 mm (n � 1), 25 mm (n � 4), 27 mm (n � 3), 29 mm (n �), and 31 mm (n � 2). The mean prosthetic valve size was
ig 1. Injectable Pulmonic Valve Shelhigh NR-4000PA-MIS. Re-rinted with permission of Shelhigh Inc.
6.8 � 2.9 mm (range, 21 to 31 mm). Prosthetic valve a
ats.ctsnetjournDownloaded from
nsertion, delivery, and placement were successful in allatients. Mean procedural time was 185.9 � 45.6 minutes
range, 120 to 240 minutes). Echocardiographic and inva-ive hemodynamic assessment showed no regurgitationn 10 patients and a mild paravalvular regurgitation in 2,
mean peak systolic gradient of 14.5 � 4.6 mm Hgrange, 10 to 20 mm Hg), and a mean systolic gradient of.3 � 1.6 mm Hg (range, 4 to 8 mm Hg). Data areummarized in Table 3.
After successful PVR, CPB was initiated in 3 patientsho underwent concomitant procedures: 2 patients with
epaired TOF needed tricuspid valve repair (DeVegalasty) because of severe tricuspid regurgitation, and 1atient with a repaired double-outlet RV underwentesidual VSD closure. Another patient with a repairedouble-outlet RV required CPB for an extensive reductionlasty of a severely dilated MPA (� 35 mm) before PVR.Early recovery was uneventful, and all the patientsere discharged home after a mean hospital length of
tay of 6.3 � 2.4 days (range, 2 to 12 days). During a meanollow-up of 6.3 � 4.3 months (range, 1.2 to 11.5 months)o patients required reoperations. Routine echocardiog-aphy and MRI during follow-up showed good results,ith low peak gradients of 15 � 4.2 mm Hg (range, 10 to
0 mm Hg), a mean gradient of an 12.4 � 2.9 mm Hgrange, 10 to 16 mm Hg), trivial valvular regurgitation,nd recovered RV function (mildly impaired to normal)n all but the 2 patients with mild paravalvular leak. Noalvular dysfunction, peel formation, or calcification wasoted. No arrhythmia was recorded during early and late
ollow-up, and mortality rate was 0%. All patients pre-ented in New York Heart Association functional class 1t the latest follow-up.In the 2 patients who had MRI studies preoperatively
nd at 7 months postoperatively, reverse RV remodellingas observed during follow-up, with a RV volume reduc-
ion between 35% and 50% (Table 4; Fig 2). Strain valuesad recovered to normal. Interventricular interaction
mproved as well within 7 months postoperatively onchocardiography in these patients (Fig 3).
omment
atients with TOF, isolated or combined with congenitalulmonary stenosis, usually need several cardiac reinter-entions during their lifetime because of sequelae, resid-al lesions, recurrent obstructions, or conduit failure.ost patients present with longstanding PR [1], which is
nown to be deleterious to RV function and to theirong-term prognosis [4, 5]. Function of the RV is further-
ore jeopardized by repetitive surgery and other condi-ions such as pressure and volume overload from resid-al VSD, recurrent obstructions, tricuspid regurgitation,r myocardial damage from RVOT scarring, and aneu-ysm. Patients may also present with impaired left ven-ricular function. A more aggressive approach withimely correction of PR is therefore currently advocated5, 7]. Because earlier PVR will inadvertently lead to anncreased number of reinterventions, the invasiveness
nd risks of PVR have to be kept as minimal as possible
1469Ann Thorac Surg MARIANESCHI ET AL2008;86:1466–72 INJECTABLE PULMONARY VALVE IMPLANTATION
AD
ULT
CA
RD
IAC
or maximum myocardial preservation. In addition, newmplants, both durable and designed for alternative im-lantation techniques should be available.Currently, surgeons try to minimize the effect of repet-
tive operations on cardiac function by performing mostf the RV and pulmonary artery procedures on CPB withbeating heart under normothermic temperatures. Thus,arly death and morbidity has consistently been reportedo be low in recent years [8, 9]. Bonhoeffer and coworkers10] have developed another approach that minimizesnvasiveness by performing PVR percutaneously.
The Shelhigh Injectable Stented Pulmonic Valve, aevice available since 2004, fulfills advantages of both theurgical and percutaneous approach. However, com-ared with the on-pump beating-heart method, the Shel-igh valve offers the advantage of eliminating completely
he use of CPB and additional right ventriculotomies. Itay therefore be less invasive, better tolerated, and offershorter hospital length of stay with faster recovery than
onventional treatment with CPB support. We think thatpproximately 10% of our patients may qualify for thisethod of PVR, but a larger amount may probably be
ncluded with continuous refinement of the selectionriteria and increased experience.
Compared with the percutaneous approach, off-pumpVR with the Shelhigh valve offers several advantages:ll sizes of implants needed are available up to size 31m, and the procedure is not limited by a small catheter
r access vessel diameter. Modified No-React treated
able 3. Perioperative and Postoperative Data
atients Peri-op (n � 12), M
peration time, min 185.9 � 45.6alve size 26.8 � 2.9eak systolic gradient, mm Hg 14.5 � 4.6ean systolic gradient, mm Hg 6.3 � 1.6
V functiona NVEDV, mL .VESV, mL .leeding, intra-op � post-op, mL 495 � 182lood transfusion, U 0ength of stay, dIntensive care unit 1.2 � 0.5Hospital 6.3 � 2.4
RV function classified as normal � 0, mild impairment � 1, moderate �
A � not available; RV � right ventricle; RVEDV � right ventricu
able 4. Magnetic Resonance Imaging Preoperative and Posto
RI Data (n � 4)Pre-op (n � 4)
Mean � SD (range)
VEDV, mL 236.5 � 51 (166–274)VESV, mL 121 � 16.1 (101–134)V Stroke volume, mL 115.5 � 43.2 (51–140)V Ejection fraction, % 47.3 � 11.4 (30.7–56.5
V � right ventricle; RVEDV � right ventricular end-diastolic volume;
ats.ctsnetjournDownloaded from
iologic valves (Shelhigh Inc, Millburn, NJ) of the latesteneration have shown promising results with respect toalcification and degeneration [11, 12] in contrast withhose implanted in earlier series and with the conduitsed for percutaneous implantation [13–16]. It also inhib-
ts scar formation between the device and the inside ofhe MPA wall, which together with some oversizing mayllow some increase in device diameter during the pa-ient’s growth, thus potentially minimizing the numberf PVRs during a patient’s lifetime.Another important advantage is that additional proce-
ures frequently necessary on the RVOT or the pulmo-ary artery, such as reduction plasty or pulmonary arteryranch enlargement, can be performed. Although in thiseries one MPA reduction plasty was done with supportf CPB, others [6] have shown that this may be doneff-pump as well.It has been shown that RVOT aneurysms negatively
ffect RV function [17, 18] and therefore need to beeduced at the time of reoperation. Furthermore, thehelhigh valve offers the potential to be used with a more
imited access other than a full sternotomy.This Shelhigh valve was used in those patients who
hen underwent CPB because concomitant procedureseeded to be done, including tricuspidal valve repair,losure of residual VSD, and extensive MPA reductionlasty. In both patients with repaired double-outlet RVnd with anteriorly lying ascending aorta and coronarynomalies crossing the RVOT, it was considered to be
� SD (range) Post-op (n � 12), Mean � SD (range)
–240) NA1) 26.8 � 2.9 (21–31)0) 15 � 4.2 (10–20)
12.4 � 2.9 (10–16)0.2 � 0.4 (0–1)
114 � 69.7 (45–174)56.6 � 34.1 (23.3–86)
0–700) NANA
) NA) NA
evere � 3.
d-diastolic volume; RVESV � right ventricular end-systolic volume.
1470 MARIANESCHI ET AL Ann Thorac SurgINJECTABLE PULMONARY VALVE IMPLANTATION 2008;86:1466–72A
DU
LTC
AR
DIA
C
ig 2. Example of a magnetic resonance image volume by frame curve of 1 patient (A) preoperatively and (B) postoperatively. (A) In the rightentricle (RV), systole is delayed, in (B) the RV function after 7 months from the implant is quantitatively and qualitatively similar to the left
entricle. The synchronization also is improved and the minimum RV volume during systole is reached in shorter time.
ig 3. Example of echocardiographic assessment of the valve and right ventricular (RV) function 7 months after implantation. (A, B) Valveosition and normal right ventricular outflow tract (RVOT) flow velocity are shown. (C, D) Right ventricular motion of the tricuspid annulus
Strain) recovered to normal. (PA � pulmonary artery; RA � right atrium.)
by on June 3, 2013 ats.ctsnetjournals.orgDownloaded from
1471Ann Thorac Surg MARIANESCHI ET AL2008;86:1466–72 INJECTABLE PULMONARY VALVE IMPLANTATION
AD
ULT
CA
RD
IAC
dvantageous to use this implantation technique. Theesponsible surgeons determined that the stented valvehat is usually used in these patients for PVR mighttretch the annulus and put tension on the abnormaloronaries. To avoid the complication of potential myo-ardial ischemia, a smaller valve would then have beenmplanted. To offer the largest valve possible withoutnterference with coronaries, the injectable Shelhighalve was selected.Preoperatively, the morphology of the RVOT andPA, including the bifurcation and the pulmonary ar-
ery, has to be studied carefully by transthoracic echo-ardiography and ideally by cardiac MRI, if available, toetermine the prosthetic valve size and decide on addi-
ional procedures [19]. Early reported experience showshat reduction plasty of an enlarged MPA of � 29 mmnd semicircular fixation of the implant should always beone to ensure a stable position and prevent paravalvu-
ar regurgitation [6]. Although no patient in our seriesas required a valve-related reoperation so far, othersave reported reoperations due to migration and para-alvular leakage in cases with a too large MPA noteduced at the time of valve insertion [6].
Handling of the device and valve implantation hasroven easy and straightforward. On a midterm fol-
ow-up of up to 11 months, the device shows excellenterformance in all patients with a correct implantationesult. Our data show that RV reverse remodeling isonsistently taking place after successful PVR.
As with any other new technology, its disadvantage ishat long-term data are lacking. Currently, availability isemporarily restricted due to a production stop of Shel-igh products enforced by the United States Food andrug Administration (see the Addendum).In conclusion, the Shelhigh Injectable Pulmonic Valve
helhigh NR-4000PA-MIS allows safe and easy pulmonaryalve replacement without CPB in carefully selected pa-ients. Its mode of implantation may offer a less invasivepproach. Special care must be taken on sizing and fixationf the device to avoid paravalvular leakage and later migra-ion. The device appears to function adequately and showso degeneration at a follow-up of up to 11 months. Longer
ollow-up is necessary to assess its performance.
lthough the Shelhigh valve has received the CE (Conformitéuropéene) mark, some European health authorities have is-ued warning letters to restrict the use of Shelhigh products toompassionate use. Therefore, only symptomatic patients withmpaired RV function with or without concomitant left ventricleysfunction may profit from this procedure at this time inertain European countries. By June 25, 2007, a no-fault settle-ent agreement was reached between Shelhigh Inc and the
ood and Drug Administration, so that resumption of operationst Shelhigh Inc can be expected within due time. This study,owever, was not affected by these issues, because neither the
talian nor the Turkish health authorities restricted the use ofhese products, nor was there a shortage of implants during the
tudy period owing to large enough stocks in Italy and Turkey.
ats.ctsnetjournDownloaded from
eferences
1. Oechslin EN, Harrison DA, Harris L, et al. Reoperation inadults with repair of Tetralogy of Fallot: indications andoutcomes. J Thorac Cardiovasc Surg 1999;118:245–51.
2. Knott-Craig CJ, Elkins RC, Lane MM, Holz J, McCue C,Ward KE. A 26-year experience with surgical managementof Tetralogy of Fallot: risk analysis for mortality or latereintervention. Ann Thorac Surg 1998;66:506–11.
3. Nollert GD, Dabritz SH, Schmoeckel M, Vicol C, Reichart B.Risk factors for sudden death after repair of Tetralogy ofFallot. Ann Thorac Surg 2003;76:1901–5.
4. Abd El, Rahman MY, Abdul-Khaliq H, Vogel M, Alexi-Meskishvili V, Gutberlet M, Lange PE. Relation betweenright ventricular enlargement, QRS duration, and right ven-tricular function in patients with Tetralogy of Fallot andpulmonary regurgitation after surgical repair. Heart 2000;84:416–20.
5. Gatzoulis MA, Balaji S, Webber SA, et al. Risk factors forarrhythmia and sudden cardiac death late after repair ofTetralogy of Fallot: a multicentre study. Lancet 2000;356:975– 81.
6. Berdat PA, Carrel TP. Off-pump pulmonary valve replace-ment with the new Shelhigh Injectable Stented PulmonicValve. J Thorac Cardiovasc Surg 2006;131:1192–3.
7. Therrien J, Siu SC, McLaughlin PR, Liu PP, Williams WG,Webb GD. Pulmonary valve replacement in adults late afterrepair of Tetralogy of Fallot: are we operating too late? J AmColl Cardiol 2000;36:1670–5.
8. Kanter KR, Budde JM, Parks WJ, et al. One hundred pulmo-nary valve replacements in children after relief of rightventricular outflow tract obstruction. Ann Thorac Surg 2002;73:1801–6; discussion 1806–7.
9. Carrel T, Berdat P, Pavlovic M, Pfammatter JP. The bovinejugular vein: a totally integrated valved conduit to repair theright ventricular outflow. J Heart Valve Dis 2002;11:552–6.
0. Bonhoeffer P, Boudjemline Y, Saliba Z, et al. Percutaneousreplacement of pulmonary valve in a right-ventricle topulmonary-artery prosthetic conduit with valve dysfunction.Lancet 2000;356:1403–5.
1. Marianeschi SM, Iacona GM, Seddio F, et al. ShelhighNo-React porcine pulmonic valve conduit: a new alternativeto the homograft. Ann Thorac Surg 2001;71:619–23.
2. Carrel TP, Berdat P, Englberger L, et al. Aortic root replace-ment with a new stentless aortic valve xenograft conduit:preliminary hemodynamic and clinical results. J Heart ValveDis 2003;12:752–7.
3. Kadner A, Dave H, Stallmach T, Turina M, Pretre R. Forma-tion of a stenotic fibrotic membrane at the distal anastomosisof bovine jugular vein grafts (Contegra) after right ventric-ular outflow tract reconstruction. J Thorac Cardiovasc Surg2004;127:285–6.
4. Meyns B, Van Garsse L, Boshoff D, et al. The Contegraconduit in the right ventricular outflow tract induces supra-valvular stenosis. J Thorac Cardiovasc Surg 2004;128:834–40.
5. Tiete AR, Sachweh JS, Roemer U, Kozlik-Feldmann R,Reichart B, Daebritz SH. Right ventricular outflow tractreconstruction with the Contegra bovine jugular vein con-duit: a word of caution. Ann Thorac Surg 2004;77:2151–6.
6. Boudjemline Y, Agnoletti G, Piechaud JF, et al. [Percutane-ous pulmonary valve replacement: towards a modification ofthe prosthesis]. Arch Mal Coeur Vaiss 2003;96:461–6.
7. Mittal SR, Agrawal D, Mathur D. Right ventricular regionalwall motion abnormality in congenital heart disease. IntJ Cardiol 1996;54:76–80.
8. Fogel MA, Rychik J. Right ventricular function in congenitalheart disease: pressure and volume overload lesions. ProgCardiovasc Dis 1998;40:343–56.
9. Schreiber C, Hoerer J, Vogt M, et al. A new treatment optionfor pulmonary valvular insufficiency: first experiences withimplantation of a self-expanding stented valve without useof cardiopulmonary bypass. Eur J Cardiothorac Surg 2007;
1472 MARIANESCHI ET AL Ann Thorac SurgINJECTABLE PULMONARY VALVE IMPLANTATION 2008;86:1466–72A
DU
LTC
AR
DIA
C
ISCUSSION
Ds
D
Dp
D
D
Do
Dpa
D
Dttcvpc
D
D
DaW
Drspc
D
R CHRISTOPHER A. CALDARONE (Toronto, Ontario, Can-da): In the first version of the manuscript, there are 2 patientsho had distal migration of the device. Could you comment on
he external fixation techniques used? Were they used in theseases? Have you evolved in terms of how you do the externalxation?
R MARIANESCHI: These 2 patients mentioned in the prelim-nary version of the manuscript come from the Bern experience.ern was the pioneer in the implantation of this valve. Theyere the first cases who received this implant. And after thoseatients, we started to fix the valve inside the pulmonary arteryith external transmural stitches. The present series reportedere does not contain any patient from the Bern experience.
R CALDARONE: So there are no migrations after you startedhe external fixation?
R MARIANESCHI: We haven’t seen any other migration.
R JOSEPH J. AMATO (Chicago, IL): I might be off-base or aittle naive, but I would ponder on the possibility of what mightappen if when you opened the heart off-bypass, that you mightncounter a previously undetected small patent foramen ovaler a previously undetected atrial septal defect. Might you notear that air might go from the right side to the left side. Howhen would you prevent or avoid the possibility of any airmbolism?
R MARIANESCHI: It’s one of the exclusion criteria. If there isn ASD [atrial septal defect] or a VSD [ventricular septal defect],e don’t do the implant of the pulmonary valve without bypass.
R CARLOS TROCONIS (Caracas, Venezuela): I’d like to knowf the reduction plasty of the MPA [main pulmonary artery] toess than 31 mm is because you don’t have any larger valve orou choose the reduction for better dynamics purpose? And theecond question is, could you explain a little more about howou do that reduction of the annulus or the pulmonary arteryff-pump?
R MARIANESCHI: The largest valve is 31, so we cannot usether valves. So the only brand we have is this one. And therere no valves larger than 31, so we have to do the reduction forhis reason. We do the reduction with a simple continuousuture to reduce the caliber on all the length of the mainulmonary artery. If there is calcification or the patient needsome reduction of the transannular patch, we don’t do that in
his kind of operation. D
ats.ctsnetjournDownloaded from
R FRANK A. PIGULA (Boston, MA): You do this through aternotomy, presumably, right?
R MARIANESCHI: Yes.
R PIGULA: And what are the advantages of this valve over theercutaneous valves that are delivered by catheter?
R MARIANESCHI: The size.
R PIGULA: The size.
R MARIANESCHI: Yes, we can put in a valve with a diameterf up to 31 mm.
R CALDARONE: And you have the potential to do a reductionlasty, which, of course, you wouldn’t do with a catheter-basedpproach, right?
R MARIANESCHI: Right.
R EMILE M. BACHA (Boston, MA): Just a clarification relatedo Dr Pigula’s question about advantages of this technique overhe percutaneous technique. The percutaneous pulmonary valvean only be implanted in patients who have right RV-PA [rightentricle–pulmonary artery] conduits. This valve can be im-lanted in a patient who has had a transannular patch; is thatorrect?
R MARIANESCHI: Yes.
R BACHA: So that would be, I think, a major difference.
R MARIANESCHI: It can be implanted in any, when thenatomy of the main pulmonary artery is cylindrical in shape.
hether it’s a conduit or a transannular patch, it doesn’t matter.
R BACHA: The vast majority of patients with PR [pulmonaryegurgitation] have had a transannular patch and not a conduit,o this valve applies to these patients, as opposed to theercutaneous valve, which has to go into a previously placedonduit.
