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Adverse Events Due to Transcatheter Pulmonary Valve Replacement: We Are Being too Hard on Ourselves.Journal of the American College of... Feb 2020
Topics: Cardiac Surgical Procedures; Humans; Pulmonary Valve; Pulmonary Valve Insufficiency; Radiation Exposure
PubMed: 32000948
DOI: 10.1016/j.jacc.2019.12.006 -
JACC. Cardiovascular Interventions Jan 2024Robust data on changes in pulmonary valve replacement (PVR) procedural volume and predictors of bioprosthetic pulmonary valve (BPV) durability in patients with tetralogy...
BACKGROUND
Robust data on changes in pulmonary valve replacement (PVR) procedural volume and predictors of bioprosthetic pulmonary valve (BPV) durability in patients with tetralogy of Fallot (TOF) are scarce.
OBJECTIVES
This study sought to assess temporal trends in PVR procedural volume and BPV durability in a nationwide, retrospective TOF cohort.
METHODS
Data were obtained from patient records. Robust linear regression was used to assess temporal trends in PVR procedural volume. Piecewise exponential additive mixed models were used to estimate BPV durability, defined as the time from implantation to redo PVR with death as a competing risk, and to assess risk factors for reduced durability.
RESULTS
In total, 546 PVR were performed in 384 patients from 1976 to 2021. The annual number of PVR increased from 0.4 to 6.0 per million population (P < 0.001). In the last decade, the transcatheter PVR volume increased by 20% annually (P < 0.001), whereas the surgical PVR volume did not change significantly. The median BPV durability was 17 years (Q1: 10-Q3: 10 years-not applicable). There was no significant difference in the durability of different BPV after adjustment for confounders. Age at PVR (HR: 0.78 per 10 years from <1 year; 95% CI: 0.63-0.96; P = 0.02) and true inner valve diameter (9-17 mm vs 18-22 mm HR: 0.40; 95% CI: 0.22-0.73; P = 0.003 and 18-22 mm vs 23-30 mm HR: 0.59; 95% CI: 0.25-1.39; P = 0.23) were associated with reduced BPV durability in multivariate models.
CONCLUSIONS
The PVR procedural volume has increased over time, with a greater increment in transcatheter than surgical PVR during the last decade. Younger patient age at PVR and a smaller true inner valve diameter predicted reduced BPV durability.
Topics: Humans; Child; Pulmonary Valve; Tetralogy of Fallot; Retrospective Studies; Heart Valve Prosthesis Implantation; Treatment Outcome; Pulmonary Valve Insufficiency
PubMed: 38127022
DOI: 10.1016/j.jcin.2023.10.070 -
Frontiers in Surgery 2015An increasing number of patients with tetralogy of Fallot require repeat surgical intervention for pulmonary valve replacement secondary to pulmonary regurgitation.... (Review)
Review
An increasing number of patients with tetralogy of Fallot require repeat surgical intervention for pulmonary valve replacement secondary to pulmonary regurgitation. Catheter-based interventions have emerged as an attractive alternative to surgery in this patient population but it is limited by patient size or the anatomy of the right ventricular outflow tract. Hybrid approaches involving both cardiac interventionists and surgeons are being developed to overcome these limitations. The purpose of this review is to highlight the recent advances in the hybrid field of pulmonary valve replacement, summarizing the advantages and disadvantages of the "traditional" surgical and the new catheter-based techniques and discuss the direction future research should take to determine the optimal management for individual patients.
PubMed: 26082929
DOI: 10.3389/fsurg.2015.00022 -
European Journal of Cardio-thoracic... Apr 2017Today, both surgical and percutaneous techniques are available for pulmonary valve implantation in patients with right ventricle outflow tract obstruction or... (Comparative Study)
Comparative Study
OBJECTIVES
Today, both surgical and percutaneous techniques are available for pulmonary valve implantation in patients with right ventricle outflow tract obstruction or insufficiency. In this controlled, non-randomized study the hospital costs per patient of the two treatment options were identified and compared.
METHODS
During the period of June 2011 until October 2014 cost data in 20 patients treated with the percutaneous technique and 14 patients treated with open surgery were consecutively included. Two methods for cost analysis were used, a retrospective average cost estimate (overhead costs) and a direct prospective detailed cost acquisition related to each individual patient (patient-specific costs).
RESULTS
The equipment cost, particularly the stents and valve itself was by far the main cost-driving factor in the percutaneous pulmonary valve group, representing 96% of the direct costs, whereas in the open surgery group the main costs derived from the postoperative care and particularly the stay in the intensive care department. The device-related cost in this group represented 13.5% of the direct costs. Length-of-stay-related costs in the percutaneous group were mean $3885 (1618) and mean $17 848 (5060) in the open surgery group. The difference in postoperative stay between the groups was statistically significant ( P ≤ 0.001).
CONCLUSIONS
Given the high postoperative cost in open surgery, the percutaneous procedure could be cost saving even with a device cost of more than five times the cost of the surgical device.
Topics: Adolescent; Adult; Child; Critical Care; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Hospital Costs; Humans; Length of Stay; Male; Minimally Invasive Surgical Procedures; Norway; Postoperative Care; Pulmonary Valve; Pulmonary Valve Insufficiency; Ventricular Outflow Obstruction; Young Adult
PubMed: 28007875
DOI: 10.1093/ejcts/ezw378 -
Turk Gogus Kalp Damar Cerrahisi Dergisi Apr 2019Iatrogenic pulmonary valve insufficiency is a life-threatening complication and its treatment options pose another challenge. Easily accessible mechanical valves have...
Iatrogenic pulmonary valve insufficiency is a life-threatening complication and its treatment options pose another challenge. Easily accessible mechanical valves have high complication rates. Xenografts and homografts are expensive materials and are not readily accessible in case of emergency. Although monoand bileaflet reconstructions with autologous pericardium in the pediatric population has been reported frequently, trileaflet reconstruction of the pulmonary valve has not been reported in the literature, yet. Herein, we, for the first time, present a case of acute pulmonary valve insufficiency which was treated with the trileaflet reconstruction of the pulmonary valve.
PubMed: 32082856
DOI: 10.5606/tgkdc.dergisi.2019.17541 -
Catheterization and Cardiovascular... Aug 2021We compared 5-year outcomes of transcatheter pulmonary valve (TPV) replacement with the Melody TPV in the post-approval study (PAS) and the investigational device...
OBJECTIVE
We compared 5-year outcomes of transcatheter pulmonary valve (TPV) replacement with the Melody TPV in the post-approval study (PAS) and the investigational device exemption (IDE) trial.
BACKGROUND
As a condition of approval of the Melody TPV after the IDE trial, the Food and Drug Administration required that a PAS be conducted to evaluate outcomes of TPV replacement in a "real-world" environment. The 5-year outcomes of the PAS have not been published, and the IDE and PAS trials have not been compared.
METHODS
The cohorts comprised all patients catheterized and implanted at 5 IDE sites and 10 PAS sites. Differences in trial protocols were detailed. Time-related outcomes and valve-related adverse events were compared between the two trials with Kaplan-Meier curves and log-rank testing.
RESULTS
167 patients (median age, 19 years) were catheterized and 150 underwent TPV replacement in the IDE trial; 121 were catheterized (median age, 17 years) and 100 implanted in the PAS. Freedom from hemodynamic dysfunction (p = .61) or any reintervention (p = .74) over time did not differ between trials. Freedom from stent fracture (p = .003) and transcatheter reintervention (p = .010) were longer in PAS, whereas freedom from explant (p = .020) and TPV endocarditis (p = .007) were shorter. Clinically important adverse events (AEs) were reported in 14% of PAS and 7.2% of IDE patients (p = .056); the incidence of any particular event was low in both.
CONCLUSIONS
Hemodynamic and time-related outcomes in the PAS and IDE trials were generally similar, confirming the effectiveness of the Melody TPV with real-world providers. There were few significant complications and limited power to identify important differences in AEs. The lack of major differences in outcomes between the two studies questions the usefulness of mandated costly post-approval studies as part of the regulatory process for Class III medical devices.
Topics: Adolescent; Adult; Cardiac Catheterization; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Prosthesis Design; Pulmonary Valve; Pulmonary Valve Insufficiency; Treatment Outcome; Young Adult
PubMed: 33780150
DOI: 10.1002/ccd.29657 -
Korean Journal of Radiology Mar 2021An increasing number of adult congenital heart disease (ACHD) patients continue to require life-long diagnostic imaging surveillance using cardiac CT and MRI. These... (Review)
Review
An increasing number of adult congenital heart disease (ACHD) patients continue to require life-long diagnostic imaging surveillance using cardiac CT and MRI. These patients typically exhibit a large spectrum of unique anatomical and functional changes resulting from either single- or multi-stage palliation and surgical correction. Radiologists involved in the diagnostic task of monitoring treatment effects and detecting potential complications should be familiar with common cardiac CT and MRI findings observed in patients with repaired complex ACHD. This review article highlights the contemporary role of CT and MRI in three commonly encountered repaired ACHD: repaired tetralogy of Fallot, transposition of the great arteries after arterial switch operation, and functional single ventricle after Fontan operation.
Topics: Contrast Media; Coronary Stenosis; Heart Defects, Congenital; Heart Ventricles; Humans; Magnetic Resonance Imaging; Pulmonary Valve Insufficiency; Tetralogy of Fallot; Tomography, X-Ray Computed; Transposition of Great Vessels
PubMed: 33289363
DOI: 10.3348/kjr.2020.0895 -
The Journal of Thoracic and... Mar 2016
Topics: Cardiac Surgical Procedures; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Palliative Care; Prosthesis Design; Pulmonary Valve; Pulmonary Valve Insufficiency; Tetralogy of Fallot; Treatment Outcome
PubMed: 26474896
DOI: 10.1016/j.jtcvs.2015.09.008 -
Archives of Cardiovascular Diseases Oct 2017The Melody pulmonary valve has received approval for the treatment of dysfunctional right ventricular (RV) outflow tract conduits ≥16mm.
BACKGROUND
The Melody pulmonary valve has received approval for the treatment of dysfunctional right ventricular (RV) outflow tract conduits ≥16mm.
AIMS
To investigate technical and clinical outcomes in patients who underwent percutaneous pulmonary valve implantation (PPVI) in conduits ≤16mm.
METHODS
Eleven patients were enrolled retrospectively between 2000 and 2015 in a cardiac referral centre.
RESULTS
The PPVI indications were obstruction (n=5); regurgitation (n=1); and mixed lesions (n=5). Pre-stenting was performed during the procedure in seven cases. Three of the remaining four patients had previous stent implantation. The mean maximal dilatation balloon diameter/surgical initial diameter ratio was 1.3. Procedural haemodynamics showed a decrease in peak RV to pulmonary artery gradient (mmHg) from 50 (14-86) to 11 (5-23) (P<0.001), in RV systolic pressure (mmHg) from 69 (35-110) to 40 (25-50) (P=0.006) and in RV/aortic systolic pressure ratio from 0.8 (0.4-1.0) to 0.4 (0.3-0.6) (P=0.004). Acute device-related complications occurred in four patients (36.4%): two confined conduit tears managed with placement of a covered stent; and two vascular access complications. Mean follow-up after PPVI was 3.9 years (41 days to 6.7 years). At last follow-up, one patient had undergone surgical conduit replacement for recurrent conduit stenosis, one had percutaneous pulmonary valve dilatation and two had developed bacterial endocarditis and undergone surgical conduit replacement. Freedom from valve dysfunction at 1, 2 and 3 years was 91%, 91% and 82%, respectively.
CONCLUSIONS
PPVI is feasible in small conduits ≤ 16mm with good procedural and early haemodynamic results, postponing the need for surgery. These results are not sustainable over time. Larger studies are needed to determine if bare-metal stent implantation as a bridge to surgical replacement provides the same results in this specific population.
Topics: Adolescent; Adult; Balloon Valvuloplasty; Cardiac Catheterization; Child; Databases, Factual; Echocardiography, Doppler; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Hemodynamics; Humans; Male; Prosthesis Design; Pulmonary Valve; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis; Recovery of Function; Retrospective Studies; Time Factors; Treatment Outcome; Ventricular Outflow Obstruction; Young Adult
PubMed: 28549918
DOI: 10.1016/j.acvd.2016.12.013 -
JACC. Cardiovascular Interventions Oct 2021
Topics: Cardiac Catheterization; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Heart Ventricles; Humans; Prosthesis Design; Pulmonary Valve; Pulmonary Valve Insufficiency; Stents; Treatment Outcome; Ventricular Outflow Obstruction
PubMed: 34600878
DOI: 10.1016/j.jcin.2021.08.015