Percutaneous pulmonary valve implantation: two-centre experience with more than 100 patients
TL;DR: This study shows that PPVI is feasible and it improves the haemodynamics in a selected patient collective and the intervention is technically challenging and longer clinical follow-up is needed.
Abstract: Aims Dysfunction of valved conduits in the right ventricular outflow tract (RVOT) limits durability and enforces repeated surgical interventions. We report on our combined two-centre experience with percutaneous pulmonary valve implantation (PPVI).
Methods and results One hundred and two patients with RVOT dysfunction [median weight: 63 kg (54.2–75.9 kg), median age: 21.5 years (16.2–30.1 years), diagnoses: TOF/PA 61, TAC 14, TGA 9, other 10, AoS post-Ross-OP 8] were scheduled for PPVI since December 2006. Percutaneous pulmonary valve implantation was performed in all patients. Pre-stenting of the RVOT was done in 97 patients (95%). The median peak systolic RVOT gradient decreased from 37 mmHg (29–46 mmHg) to 14 mmHg (9–17 mmHg, P < 0.001) and the ratio RV pressure/AoP decreased from 62% (53–76%) to 36% (30–42%, P < 0.0001). The median end-diastolic RV-volume index (MRI) decreased from 106 mL/m2 (93–133 mL/m2) to 90 mL/m2 (71–108 mL/m2, P = 0.001). Pulmonary regurgitation was significantly reduced in all patients. One patient died due to compression of the left coronary artery. The incidence of stent fractures was 5 of 102 (5%). During follow-up [median: 352 days (99–390 days)] one percutaneous valve had to be removed surgically 6 months after implantation due to bacterial endocarditis. In 8 of 102 patients, a repeated dilatation of the valve was done due to a significant residual systolic pressure gradient, which resulted in a valve-in-valve procedure in four.
Conclusion This study shows that PPVI is feasible and it improves the haemodynamics in a selected patient collective. Apart from one coronary compression, the rate of complications at short-term follow-up was low. Percutaneous pulmonary valve implantation can be performed by experienced interventionalists with similar results as originally published. The intervention is technically challenging and longer clinical follow-up is needed.
Citations
More filters
TL;DR: TPV replacement with the Melody valve provided good hemodynamic and clinical outcomes up to 7 years after implantation and a conduit prestent and lower discharge right ventricular outflow tract gradient were associated with longer freedom from reintervention.
Abstract: Background—Studies of transcatheter pulmonary valve (TPV) replacement with the Melody valve have demonstrated good short-term outcomes, but there are no published long-term follow-up data. Methods ...
268 citations
Houston Methodist Hospital1, MedStar Health2, Mayo Clinic3, Morristown Medical Center4, Baylor University Medical Center5, Columbia University Medical Center6, Harvard University7, Baystate Medical Center8, Icahn School of Medicine at Mount Sinai9, Cedars-Sinai Medical Center10, Cleveland Clinic11, Emory University12, University of Toronto13, Boston Children's Hospital14, West Virginia University15
TL;DR: The guidelines for the Evaluation of Valvular Regurgitation After Percutaneous Valve Repair or Replacement are published.
Abstract: The followi document: MD, FASE; sukochi, M following a M. Asch, M core lab pro tis, Abbott/ DirectFlow D. Gillam,M tronic; Pau dyne and r Medtronic, Guidelines for the Evaluation of Valvular Regurgitation After Percutaneous Valve Repair or Replacement A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Angiography and Interventions, Japanese Society of Echocardiography, and Society for Cardiovascular Magnetic Resonance
232 citations
Additional excerpts
...This information is crucial in pre-procedural assessment for TPVR, as certain anatomic criteria must be met before valve implantation.(162,163,169) Ensuring that the outflow tract/conduit is of an appropriate size to accept a TPVR valve (not too small or too large) and that there is an appropriate ‘‘landing zone’’ to seat the valve are both critical....
[...]
TL;DR: Bacterial endocarditis has occurred in all 3 prospective multicenter studies of the Melody valve in North America and Europe and most cases did not involve the TPV and responded to antibiotics.
Abstract: Background—Transcatheter (percutaneous) pulmonary valve (TPV) replacement has emerged as a viable therapy for right ventricular outflow tract conduit dysfunction. Little is known about the incidence, clinical course, and outcome of infective endocarditis (IE) after TPV implant. We reviewed combined data from 3 ongoing prospective multicenter trials to evaluate the experience with IE among patients undergoing TPV replacement using the Melody valve. Methods and Results—Any clinical episode reported by investigators as IE with documented positive blood cultures and fever, regardless of TPV involvement, was considered IE. Cases were classified as TPV-related if there was evidence of vegetations on or new dysfunction of the TPV. The 3 trials included 311 patients followed for 687.1 patient-years (median, 2.5 years). Sixteen patients were diagnosed with IE 50 days to 4.7 years after TPV implant (median, 1.3 years), including 6 who met criteria for TPV-related IE: 3 with vegetations, 2 with TPV dysfunction, and ...
183 citations
Cites background from "Percutaneous pulmonary valve implan..."
...maximal reduction of RVOT gradient at the time of Melody valve implant will decrease the risk of IE, they do offer a convenient reminder that a limitation of TPV therapy can be residual or recurrent obstruction and that implanters should strive to maximize gradient reduction at the time of TPV implant.(9,11,12,21)...
[...]
...One of these cases of IE was reported in a prior publication.(11) The total duration of follow-...
[...]
TL;DR: CA compression following TPV implantation can be catastrophic, and was significantly associated with the presence of abnormal CA anatomy, especially in patients with tetralogy of Fallot or transposition of the great arteries.
Abstract: Background— The Melody transcatheter pulmonary valve (TPV) was approved for implantation in obstructed right ventricular outflow tract conduits in 2010 after a multicenter trial demonstrating improvements in conduit obstruction, regurgitation, and right ventricular pressure. A recognized risk and contraindication to TPV implantation is the demonstration of coronary artery (CA) compression during balloon angioplasty or stent placement in the overlying conduit. This study is the first to characterize the risk of CA compression in this population. Methods and Results— From 2007 to 2012, 404 patients underwent 407 catheterizations for potential TPV implantation (median age, 18 years) at 4 centers. Three hundred forty-three patients (85%) underwent valve implantation. Twenty-one patients (5%) had evidence of CA compression with simultaneous right ventricular outflow tract angioplasty and CA angiography. Sixty-eight patients (17%) had abnormal CA anatomy. Fifteen of 21 (71%) patients with CA compression had abnormal CA anatomy. Eight patients with tetralogy of Fallot and 7 patients with transposition of the great arteries demonstrated compression. Of the 34 patients with tetralogy of Fallot and abnormal CA, 7 (21%) demonstrated CA compression. Conclusions— CA compression following TPV implantation can be catastrophic. CA compression was observed in 5% of patients during test balloon angioplasty. No patients in this study developed clinically apparent CA compression after TPV implantation. CA compression was significantly associated with the presence of abnormal CA anatomy, especially in patients with tetralogy of Fallot or transposition of the great arteries. Preimplantation coronary angiography with simultaneous test angioplasty is an important step to evaluate for the presence of CA compression during TPV implantation.
181 citations
TL;DR: The aim was to analyze data of patients treated in Italy by using the Melody Medtronic valve and found no significant differences in the results between the two types of implantation.
Abstract: Background and aims
Percutaneous implantation of pulmonary valve has been recently introduced in the clinical practice. Our aim was to analyze data of patients treated in Italy by using the Melody Medtronic valve.
Methods
Prospective, observational, multi-centric survey by means of a web-based database registry of the Italian Society of Pediatric Cardiology (SICP).
Results
Between October 2007 and October 2010, 63 patients were included in the registry (median age: 24 years; range 11–65 years). Forty subjects were in NYHA class I–II while 23 were in NYHA class III–IV. Patients included had a history of a median three previous surgeries (range 1–5) and a median of one previous cardiac catheterization (range 0–4). A cono-truncal disease was present in 39 patients, previous Ross operation in 9, and other diagnosis in 15. Indication to valve implantation was pure stenosis in 21 patients, pure regurgitation in 12, association of stenosis and regurgitation in 30. Implantation was performed in 61 subjects (97%). Pre-stenting was performed in 85% of cases. Median procedure time was 170 minutes (range 85–360). No significant regurgitation was recorded after procedure while the trans-pulmonary gradient reduced significantly. Early major complications occurred in seven subjects (11%). One death occurred in the early post-operative period in a severely ill subject. At a median follow-up of 30 months (range 12–48 months), three patients died due to underlying disease. Major complications occurred in six patients during follow-up (external electric cardioversion: one patient; herpes virus encephalitis: two patients; Melody valve endocarditis needing surgical explant: two patients; major fractures of the stent and need second Melody valve implantation: two patients). Freedom from valve failure at latest follow-up was 81.4% ± 9%.
Conclusion
Early results of the SICP registry on transcatheter Melody pulmonary valve implantation show that the procedure is safe and successful. Major concerns are related to the occurrence of stent fracture and bacterial endocarditis. Longer follow-up and larger series are needed. © 2012 Wiley Periodicals, Inc.
153 citations
Cites background from "Percutaneous pulmonary valve implan..."
...study [11] had a follow-up of 12 months as the German registry [13]....
[...]
...This problem has been reported in another case in the German registry [13], and it highlights the importance of bacterial endocarditis prophylaxis after melody valve implantation, which seems to be prone to bacteria in the setting of a stent....
[...]
References
More filters
TL;DR: In this article, the authors examined surgical, electrocardiographic, and late haemodynamic data, and their relation to clinical arrhythmia and sudden death occurring over 10 years, in a multicentre cohort of patients with repaired tetralogy.
1,565 citations
TL;DR: It is shown that percutaneous valve replacement in the pulmonary position is possible and with further technical improvements, this new technique might also be used for valve Replacement in other cardiac and non-cardiac positions.
1,028 citations
"Percutaneous pulmonary valve implan..." refers background or result in this paper
...The presented results are similar to those presented by Bonhoeffer et al.(5)....
[...]
...One larger study showed that adult sized valved conduits (.18 mm) have a mean freedom from reoperation of 11.2 years.4 To expand the lifetime of these biological conduits and to reduce the number of operations during a lifetime Bonhoeffer et al.5 developed the concept of percutaneous pulmonary valve implantation (PPVI)....
[...]
...The presented results are similar to those presented by Bonhoeffer et al.5....
[...]
...To expand the lifetime of these biological conduits and to reduce the number of operations during a lifetime Bonhoeffer et al.(5) developed the concept of percutaneous pulmonary valve implantation (PPVI)....
[...]
TL;DR: Chronic right ventricular volume overload after tetralogy of Fallot repair is related to diastolic function and correlated with QRS prolongation and the risk of symptomatic arrhythmia is high when markedright ventricular enlargement and QRS prolongedation develop.
Abstract: Background Life-threatening ventricular arrhythmia and sudden death remain serious late complications after tetralogy of Fallot repair. Nevertheless, there remains no clear way of predicting which patients are at risk. Methods and Results The study population included a total of 178 adult survivors (mean follow-up, 21.4 years) of tetralogy of Fallot repair who were currently attending our clinic. Mechanoelectrical relations were sought in 41 of the patients (mean follow-up, 23.6 years) who were operated on by one surgeon and who were prospectively studied with a 12-lead ECG, chest radiography, and two-dimensional and Doppler echocardiography. Nine patients (mean follow-up, 17 years) from the total group of 178 were identified as having had sustained ventricular tachycardia (8 with near-miss sudden death), and their ECGs, Holter monitor readings, electrophysiological studies, and chest radiographs were reviewed. The case notes of an additional 4 patients with postoperative sudden cardiac death also were av...
743 citations
"Percutaneous pulmonary valve implan..." refers background in this paper
...The correlation between QRS duration and RV dilation as a risk factor for sudden death long term after Fallot correction is known for years.(18,19) Today cMRI is the best diagnostic tool to assess ventricular volumes, mass, and function....
[...]
TL;DR: Right ventricular recovery following PVR for chronic significant pulmonary regurgitation after repair of TOF may be compromised in the adult population and pulmonary valve implant in these patients should be considered before RV function deteriorates.
547 citations