Patient outcomes after transcatheter and surgical pulmonary valve replacement for pulmonary regurgitation in patients with repaired tetralogy of Fallot: A quasi-meta-analysis
Restricted accessResearch articleFirst published online August, 2017
Patient outcomes after transcatheter and surgical pulmonary valve replacement for pulmonary regurgitation in patients with repaired tetralogy of Fallot: A quasi-meta-analysis
Individuals with repaired tetralogy of Fallot develop pulmonary regurgitation that may cause symptoms (dyspnea, chest pain, palpitations, fatigue, presyncope, and syncope), impair functional capacity, and may affect health-related quality of life. Surgical pulmonary valve replacement is the gold standard of treatment although transcatheter pulmonary valve replacement is becoming more common. Patients want to know whether less invasive options are as good.
Aims:
This analysis aimed to examine the differences in surgical versus transcatheter pulmonary valve replacement effects in terms of physiological/biological variables, symptoms, functional status and health-related quality of life.
Methods:
This quasi-meta-analysis included 85 surgical and 47 transcatheter pulmonary valve replacement studies published between 1995–2016.
Results:
In terms of physiological/biological variables, both surgical and transcatheter pulmonary valve replacement improved pulmonary regurgitation and systolic and diastolic right ventricular volume indices but not heart function. In the left heart, only surgical pulmonary valve replacement improved heart function. Only transcatheter pulmonary valve replacement improved left ventricular end-diastolic indices and neither improved endsystolic indices. Only surgery has been demonstrated to decrease QRS duration but there is little evidence of arrhythmia reduction. Symptom change is poorly documented. Functional class improves but exercise capacity generally does not. Some aspects of health-related quality of life improve with surgery and in one small transcatheter pulmonary valve replacement study.
Conclusion:
Transcatheter and surgical pulmonary valve replacement compare favorably for heart remodeling. Exercise capacity does not change with either technique. Health-related quality of life improves after surgical pulmonary valve replacement. There are numerous gaps in documentation of changes in arrhythmias and symptoms.
MozaffarianDBenjaminEJGoAS. Heart disease and stroke statistics–2016 update: A report from the American Heart Association. Circulation2016; 133: e38–e360.
3.
LilleheiCWCohenMWardenHE. The results of direct vision closure of ventricular septal defects in eight patients by means of controlled cross circulation. Surg Gynecol Obstet1955; 101: 446–466.
4.
HickeyEJVeldtmanGBradleyTJ. Functional health status in adult survivors of operative repair of tetralogy of Fallot. Am J Cardiol2012; 109: 873–880.
5.
MurphyJGGershBJMairDD. Long-term outcome in patients undergoing surgical repair of tetralogy of Fallot. N Engl J Med1993; 329: 593–599.
6.
NollertGFischleinTBouterwekS. Long-term survival in patients with repair of tetralogy of Fallot: 36-Year follow-up of 490 survivors of the first year after surgical repair. J Am Coll Cardiol1997; 30: 1374–1383.
7.
NorgaardMALauridsenPHelvindM. Twenty-to-thirty-seven-year follow-up after repair for Tetralogy of Fallot. Eur J Cardiothorac Surg1999; 16: 125–130.
8.
FrigiolaAHughesMTurnerM. Physiological and phenotypic characteristics of late survivors of tetralogy of fallot repair who are free from pulmonary valve replacement. Circulation2013; 128: 1861–1868.
9.
HickeyEJVeldtmanGBradleyTJ. Late risk of outcomes for adults with repaired tetralogy of Fallot from an inception cohort spanning four decades. Eur J Cardiothorac Surg2009; 35: 156–164; discussion 164.
10.
KogonBERosenblumJMMoriM. Current readings: Issues surrounding pulmonary valve replacement in repaired tetralogy of Fallot. Semin Thorac Cardiovasc Surg2015; 27: 57–64.
11.
WilsonIBClearyPD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA1995; 273: 59–65.
12.
KhairyPAboulhosnJGurvitzMZ. Arrhythmia burden in adults with surgically repaired tetralogy of Fallot: A multi-institutional study. Circulation2010; 122: 868–875.
13.
GevaTSandweissBMGauvreauK. Factors associated with impaired clinical status in long-term survivors of tetralogy of Fallot repair evaluated by magnetic resonance imaging. J Am Coll Cardiol2004; 43: 1068–1074.
14.
VerheugtCLUiterwaalCSvan der VeldeET. Mortality in adult congenital heart disease. Eur Heart J2010; 31: 1220–1229.
15.
GurvitzMBurnsKMBrindisR. Emerging research directions in adult congenital heart disease: A report from an NHLBI/ACHA working group. J Am Coll Cardiol2016; 67: 1956–1964.
16.
CottsTKhairyPOpotowskyAR. Clinical research priorities in adult congenital heart disease. Int J Cardiol2014; 171: 351–360.
17.
DunneBXiaoALittonE. Mechanical prostheses for right ventricular outflow tract reconstruction: A systematic review and meta-analysis. Ann Thorac Surg2015; 99: 1841–1847.
18.
CheathamSLHolzerRJChisolmJL. The Medtronic Melody(R) transcatheter pulmonary valve implanted at 24-mm diameter–it works. Catheter Cardiovasc Interv2013; 82: 816–823.
19.
ZahnEMHellenbrandWELockJE. Implantation of the Melody transcatheter pulmonary valve in patients with a dysfunctional right ventricular outflow tract conduit early results from the U.S. clinical trial. J Am Coll Cardiol2009; 54: 1722–1729.
20.
PhillipsABNevinPShahA. Development of a novel hybrid strategy for transcatheter pulmonary valve placement in patients following transannular patch repair of tetralogy of Fallot. Catheter Cardiovasc Interv2016; 87: 403–410.
21.
DittrichSGloecklerMArnoldR. Hybrid pulmonary valve implantation: Injection of a self-expanding tissue valve through the main pulmonary artery. Ann Thorac Surg2008; 85: 632–634.
22.
Abu SalehWKLinCHBreinholtJP. Hybrid approach to pulmonary valve replacement with Melody prosthesis following pulmonary banding. J Card Surg2016; 31: 174–176.
23.
TravelliFCHerringtonCSIngFF. A novel hybrid technique for transcatheter pulmonary valve implantation within a dilated native right ventricular outflow tract. J Thorac Cardiovasc Surg2014; 148: e145–e146.
24.
SchreiberCHorerJVogtM. A new treatment option for pulmonary valvar insufficiency: First experiences with implantation of a self-expanding stented valve without use of cardiopulmonary bypass. Eur J Cardiothorac Surg2007; 31: 26–30.
25.
ChenXJSmithPBJaggersJ. Bioprosthetic pulmonary valve replacement: Contemporary analysis of a large, single-center series of 170 cases. J Thorac Cardiovasc Surg2013; 146: 1461–1466.
FinchWLeviDSSalemM. Transcatheter melody valve placement in large diameter bioprostheses and conduits: What is the optimal “landing zone”?Catheter Cardiovasc Interv2015; 86: E217–E223.
28.
GillespieMJRomeJJLeviDS. Melody valve implant within failed bioprosthetic valves in the pulmonary position: A multicenter experience. Circ Cardiovasc Interv2012; 5: 862–870.
29.
NordmeyerJCoatsLLurzP. Percutaneous pulmonary valve-in-valve implantation: A successful treatment concept for early device failure. Eur Heart J2008; 29: 810–815.
30.
WilsonWMBensonLNOstenMD. Transcatheter pulmonary valve replacement with the Edwards Sapien system: The Toronto experience. JACC Cardiovasc Interv2015; 8: 1819–1827.
31.
StroupDFBerlinJAMortonSC. Meta-analysis of observational studies in epidemiology: A proposal for reporting. Meta-analysis of observational studies in epidemiology (MOOSE) group. JAMA2000; 283: 2008–2012.
32.
HollyC. Systematic review of experimental evidence: Meta-analysis. In: HollyCSalmondSWSaimbertMK (eds) Comprehensive systematic review for advanced nursing practice. New York: Springer, 2012, pp.165–187.
33.
GevaTGauvreauKPowellAJ. Randomized trial of pulmonary valve replacement with and without right ventricular remodeling surgery. Circulation. 2010; 122: S201–S208.
34.
TherrienJSiuSCHarrisL. Impact of pulmonary valve replacement on arrhythmia propensity late after repair of tetralogy of Fallot. Circulation2001; 103: 2489–2494.
35.
RotesASConnollyHMWarnesCA. Ventricular arrhythmia risk atratification in patients with tetralogy of Fallot at the time of pulmonary valve replacement. Circ Arrhythm Electrophysiol2015; 8: 110–116.
36.
OosterhofTVliegenHWMeijboomFJ. Long-term effect of pulmonary valve replacement on QRS duration in patients with corrected tetralogy of Fallot. Heart2007; 93: 506–509.
37.
HarrildDMBerulCICecchinF. Pulmonary valve replacement in tetralogy of Fallot: Impact on survival and ventricular tachycardia. Circulation2009; 119: 445–451.
CheathamJPBergersenLGillespieM. Initial results from the early feasibility study of the medtronic native outflow tract transcatheter pulmonary valve. J Am Coll Cardiol2016; 67: 929.
40.
CoolsBBrownSCHeyingR. Percutaneous pulmonary valve implantation for free pulmonary regurgitation following conduit-free surgery of the right ventricular outflow tract. Int J Cardiol2015; 186: 129–135.
41.
Malekzadeh-MilaniSLadouceurMCohenS. Results of transcatheter pulmonary valvulation in native or patched right ventricular outflow tracts. Arch Cardiovasc Dis2014; 107: 592–598.
42.
ButeraGMilanesiOSpadoniI. Melody transcatheter pulmonary valve implantation. Results from the registry of the Italian Society of Pediatric Cardiology. Catheter Cardiovasc Interv2013; 81: 310–316.
43.
FazaNKennyDKavinskyC. Single-center comparative outcomes of the Edwards SAPIEN and Medtronic Melody transcatheter heart valves in the pulmonary position. Catheter Cardiovasc Interv2013; 82: E535–E541.
44.
KhambadkoneSCoatsLTaylorA. Percutaneous pulmonary valve implantation in humans: Results in 59 consecutive patients. Circulation2005; 112: 1189–1197.
45.
TherrienJSiuSCHarrisL. Impact of pulmonary valve replacement on arrhythmia propensity late after repair of tetralogy of fallot. Circulation2001; 103: 2489–2494.
46.
OosterhofTMeijboomFJVliegenHW. Long-term follow up of homograft function after pulmonary valve replacement in patients with tetralogy of Fallot. Eur Heart J2006; 27: 396–397.
47.
DiscigilBDearaniJAPugaFJ. Late pulmonary valve replacement after repair of tetralogy of Fallot. J Thorac Cardiovasc Surg2001; 121: 344–351.
48.
ShinkawaTAnagnostopoulosPVJohnsonNC. Performance of bovine pericardial valves in the pulmonary position. Ann Thorac Surg2010; 90: 1295–1300.
49.
GengsakulAHarrisLBradleyTJ. The impact of pulmonary valve replacement after tetralogy of Fallot repair: A matched comparison. Eur J Cardiothorac Surg2007; 32: 462–468.
50.
Pijuan-DomenechAPinedaVCastroMA. Pulmonary valve replacement diminishes the presence of restrictive physiology and reduces atrial volumes: A prospective study in tetralogy of Fallot patients. Int J Cardiol2014; 177: 261–265.
51.
TsangFHWongSJCheungYF. Pulmonary valve replacement and quality-of-life assessment. Asian Cardiovasc Thorac Ann2016; 24: 5–11.
52.
LewisMJSinghHGinnsJ. Quality of life in patients with tetralogy of Fallot after pulmonary valve replacement: Is there an association with improvement in right ventricular size by cardiac MRI?JACC2016; 67: 966.
53.
Rand Corporation. 36-Item short form survey (SF-36). Santa Monica, CA: Rand Corporation, 2016.
54.
HealthActCHQ Inc. CHQ: Child health questionnaire. Boston, MA: HealthActCHQ Inc., 2016.
55.
MullerJEngelhardtAFratzS. Improved exercise performance and quality of life after percutaneous pulmonary valve implantation. Int J Cardiol2014; 173: 388–392.
56.
NordmeyerJLurzPKhambadkoneS. Pre-stenting with a bare metal stent before percutaneous pulmonary valve implantation: Acute and 1-year outcomes. Heart2011; 97: 118–123.
57.
HarrildDMMarcusEHasanB. Impact of transcatheter pulmonary valve replacement on biventricular strain and synchrony assessed by cardiac magnetic resonance feature tracking. Circ Cardiovasc Interv2013; 6: 680–687.
58.
FraisseAAldebertPMalekzadeh-MilaniS. Melody (R) transcatheter pulmonary valve implantation: Results from a French registry. Arch Cardiovasc Dis2014; 107: 607–614.
59.
EickenAEwertPHagerA. Percutaneous pulmonary valve implantation: Two-centre experience with more than 100 patients. Eur Heart J2011; 32: 1260–1265.
60.
CheungGVejlstrupNIhlemannN. Infective endocarditis following percutaneous pulmonary valve replacement: Diagnostic challenges and application of intra-cardiac echocardiography. Int J Cardiol2013; 169: 425–429.
61.
CheathamJPHellenbrandWEZahnEM. Clinical and hemodynamic outcomes up to 7 years after transcatheter pulmonary valve replacement in the US Melody valve investigational device exemption trial. Circulation2015; 131: 1960–1970.
62.
BorikSCreanAHorlickE. Percutaneous pulmonary valve implantation: 5 Years of follow-up: Does age influence outcomes?Circ Cardiovasc Interv2015; 8: e001745.
63.
BermanDPMcElhinneyDBVincentJA. Feasibility and short-term outcomes of percutaneous transcatheter pulmonary valve replacement in small (<30 kg) children with dysfunctional right ventricular outflow tract conduits. Circ Cardiovasc Interv2014; 7: 142–148.
64.
ArmstrongAKBalzerDTCabalkaAK. One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study. JACC Cardiovasc Interv2014; 7: 1254–1262.
65.
Malekzadeh-MilaniSLadouceurMPatelM. Incidence and predictors of Melody(R) valve endocarditis: A prospective study. Arch Cardiovasc Dis2015; 108: 97–106.
66.
BuberJBergersenLLockJE. Bloodstream infections occurring in patients with percutaneously implanted bioprosthetic pulmonary valve: A single-center experience. Circ Cardiovasc Interv2013; 6: 301–310.
67.
MeadowsJJMoorePMBermanDP. Use and performance of the Melody Transcatheter Pulmonary Valve in native and postsurgical, nonconduit right ventricular outflow tracts. Circ Cardiovasc Interv2014; 7: 374–380.
68.
McElhinneyDBBensonLNEickenA. Infective endocarditis after transcatheter pulmonary valve replacement using the Melody valve: Combined results of 3 prospective North American and European studies. Circ Cardiovasc Interv2013; 6: 292–300.
69.
UgakiSRutledgeJAl AklabiM. An increased incidence of conduit endocarditis in patients receiving bovine jugular vein grafts compared to cryopreserved homograft for right ventricular outflow reconstruction. Ann Thorac Surg2015; 99: 140–146.
70.
MoiduddinNAsohKSlorachC. Effect of transcatheter pulmonary valve implantation on short-term right ventricular function as determined by two-dimensional speckle tracking strain and strain rate imaging. Am J Cardiol2009; 104: 862–867.
71.
LurzPGiardiniATaylorAM. Effect of altering pathologic right ventricular loading conditions by percutaneous pulmonary valve implantation on exercise capacity. Am J Cardiol2010; 105: 721–726.
72.
HallbergsonAGauvreauKPowellAJ. Right ventricular remodeling after pulmonary valve replacement: Early gains, late losses. Ann Thorac Surg2015; 99: 660–666.
73.
van StratenAVliegenHWHazekampMG. Right ventricular function after pulmonary valve replacement in patients with tetralogy of Fallot. Radiology2004; 233: 824–829.
74.
van StratenAVliegenHWLambHJ. Time course of diastolic and systolic function improvement after pulmonary valve replacement in adult patients with tetralogy of Fallot. J Am Coll Cardiol2005; 46: 1559–1564.
75.
GevaT. Repaired tetralogy of Fallot: The roles of cardiovascular magnetic resonance in evaluating pathophysiology and for pulmonary valve replacement decision support. J Cardiovasc Magn Reson2011; 13: 9–24.
76.
TherrienJProvostYMerchantN. Optimal timing for pulmonary valve replacement in adults after tetralogy of Fallot repair. Am J Cardiol2005; 95: 779–782.
77.
OosterhofTvan StratenAVliegenHW. Preoperative thresholds for pulmonary valve replacement in patients with corrected tetralogy of Fallot using cardiovascular magnetic resonance. Circulation2007; 116: 545–551.
78.
BuechelERDaveHHKellenbergerCJ. Remodelling of the right ventricle after early pulmonary valve replacement in children with repaired tetralogy of Fallot: Assessment by cardiovascular magnetic resonance. Eur Heart J2005; 26: 2721–2727.
79.
Alvarez-FuenteMGarrido-LestacheEFernandez-PinedaL. Timing of pulmonary valve replacement: How much can the right ventricle dilate before it looses its remodeling potential?Pediatr Cardiol2016; 37: 601–605.
80.
BokmaJPWinterMMOosterhofT. Preoperative thresholds for mid-to-late haemodynamic and clinical outcomes after pulmonary valve replacement in tetralogy of Fallot. Eur Heart J2016; 37: 829–835.
81.
QuailMAFrigiolaAGiardiniA. Impact of pulmonary valve replacement in tetralogy of Fallot with pulmonary regurgitation: A comparison of intervention and nonintervention. Ann Thorac Surg2012; 94: 1619–1626.
82.
Ferraz CavalcantiPESaMPSantosCA. Pulmonary valve replacement after operative repair of tetralogy of Fallot: Meta-analysis and meta-regression of 3,118 patients from 48 studies. J Am Coll Cardiol2013; 62: 2227–2243.
83.
GoldmuntzEClarkBJMitchellLE. Frequency of 22q11 deletions in patients with conotruncal defects. J Am Coll Cardiol1998; 32: 492–498.
84.
Mercer-RosaLParidonSMFogelMA. 22q11. 2 deletion status and disease burden in children and adolescents with tetralogy of Fallot. Circ Cardiovasc Genet2015; 8: 74–81.
85.
McElhinneyDBHellenbrandWEZahnEM. Short- and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial. Circulation2010; 122: 507–516.
86.
GratzAHessJHagerA. Self-estimated physical functioning poorly predicts actual exercise capacity in adolescents and adults with congenital heart disease. Eur Heart J2009; 30: 497–504.
87.
WarnesCAWilliamsRGBashoreTM. ACC/AHA 2008 Guidelines for the Management of Adults with Congenital Heart Disease: Executive summary: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing committee to develop guidelines for the management of adults with congenital heart disease). Circulation2008; 118: 2395–2451.
88.
GradyKLLeeRSubaciusH. Improvements in health-related quality of life before and after isolated cardiac operations. Ann Thorac Surg2011; 91: 777–783.
89.
Van DoornCYatesRTunstillA. Quality of life in children following mitral valve replacement. Heart2000; 84: 643–647.
90.
ChowdhurySMHijaziZMRhodesJ. Early echocardiographic changes after percutaneous implantation of the Edwards SAPIEN transcatheter heart valve in the pulmonary position. Echocardiography2013; 30: 786–793.
91.
AboulhosnJALluriGGurvitzMZ. Left and right ventricular diastolic function in adults with surgically repaired tetralogy of Fallot: A multi-institutional study. Can J Cardiol2013; 29: 866–872.
92.
FrigiolaAGiardiniATaylorA. Echocardiographic assessment of diastolic biventricular properties in patients operated for severe pulmonary regurgitation and association with exercise capacity. Eur Heart J Cardiovasc Imaging2012; 13: 697–702.
Supplementary Material
Please find the following supplemental material available below.
For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.
For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.
