Pulmonary versus aortic pressure behavior of a bovine pericardial valve.

BACKGROUND: The Carpentier Edwards Perimount Magna Ease aortic valvular prosthesis (Edwards Lifesciences, Irvine, Calif) has been among the most frequently and successfully used tissue prosthetic cardiac valves. Furthermore, this prosthesis has been used off-label in the pulmonary position. Until now, there has been a paucity of data regarding the functioning of tissue prosthetic valves under pulmonary conditions. METHODS: Using a pulse duplicator, hydrodynamic characteristics of a 21-mm and 25-mm Magna Ease valve were evaluated. Among parameters evaluated were leakage orifice area, closing time (ie, time required to close), and leakage duration. This procedure was performed under different pulmonic pressure conditions (15/5 mm Hg, 28/11 mm Hg, 73/32 mm Hg) and normal aortic pressure (120/80 mm Hg) as a reference. Moving images were obtained using a Phantom MIRO M320S high-speed camera (Vision Research Inc, Wayne, NJ) at 600 frames per second and used to analyze valve area in closed position. RESULTS: Under normal pulmonic conditions (28/11 mm Hg) the leakage orifice area was 0.020 ± 0.012 mm2 for the 21-mm valve and 0.054 ± 0.041 mm2 for the 25-mm valve (P = .03). Hydrodynamic characteristics of the valves differed between pulmonary and aortic testing condition. Valve closing volumes were significantly lower under pulmonary hypotension and normal pulmonary conditions than under normal aortic conditions (P < .05). CONCLUSIONS: Under normal pulmonary pressure conditions, the hydrodynamic characteristics of Magna Ease valves are significantly different compared with aortic conditions. Further research is needed to determine whether these results are associated with prosthetic valve failure.

A stented bovine pericardial prosthesis in the pulmonary position.

BACKGROUND: Pulmonary valve replacement is very common among patients with congenital heart disease. The Carpentier Edwards Perimount valve (Edwards Lifesciences, Irvine, Calif), which was originally designed for the aortic position is among the most implanted valves. We aim to describe the follow-up of this valve in the pulmonary position. METHODS: Patients with a Perimount valve implanted between 2003 and 2013 in the University Medical Center Groningen were followed for the primary end point reintervention, defined as surgical or transcatheter valve replacement. Secondary end point was the occurrence of valve failure, defined as significant valvular regurgitation or stenosis. Explanted valves were histologically examined. RESULTS: Forty-five patients (median age at operation 27.8 years, 55.6% women) had a mean follow-up duration of 5.8 ± 3.3 years. There were 7 reinterventions (5 surgical and 2 transcatheter). Freedom from reintervention was respectively 95% ± 4% and 83% ± 8% at 5- and 10- years of follow-up. Freedom from valve failure was 75% ± 4% at 2 years, 65% ± 8% at 5 years of follow-up and 57% ± 10% at 10 years of follow-up. Morphology evaluation (n = 4) showed stiffened valves in the open position, with extensive fibrous tissue overgrowth on the leaflets and a variable proliferation of myofibroblasts. CONCLUSIONS: The Perimount valve has adequate function in the pulmonary valve position at 5 years of follow-up, although after 10 years of follow-up valve failure and reinterventions are common. Explanted valves show retraction and stiffening of the leaflets due to a fibrotic layer on both sides of the leaflet.

Influence of Transvalvar Pressure Gradient on Hinge Washing in Closed Mechanical Prosthetic Cardiac Valves Under Pulmonary Pressure Conditions: A Comparative In Vitro Study.

OBJECTIVE: Hinge washing is a crucial factor in the prevention of mechanical prosthetic valvar thrombosis, especially in the pulmonary valve position. The aim of this laboratory study was to determine the relationship between pressure difference and the amount of hinge washing in the closed position, using the pressures that are normal for the right ventricle and pulmonary artery. METHODS: In an in vitro setting, four different bileaflet mechanical valves were tested for hinge washing in closed position. Based on similarity in inner diameter (range: 20.5-21.4 mm), the following valves were tested: Abbott SJM Regent size 23, Cryolife On-X size 23, LivaNova Carbomedics-R size 25, Medtronic Open Pivot (M-OP)-A size 25. Tests were carried out in a range between 3 and 100 mm Hg pressure difference, using water as a test fluid. The amount of leakage per minute through the closed valve was measured. RESULTS: All four valves showed an increase in leakage with increasing transvalvar gradient, and the relationship between pressure and leakage behaves in logarithmic fashion. Leakage under normal pulmonary diastolic pressure conditions (10 mm Hg) was between 23.3% and 29.3% of the leakage under aortic diastolic pressure conditions (80 mm Hg). The Cryolife On-X valve showed the highest closed leakage volume under pulmonary conditions (10 mm Hg) 0.254 ± 0.01 (L/min), where the Medtronic M-OP showed the lowest leakage volume with 0.125 ± 0.014 (mL/min). CONCLUSION: Hinge washing is related to transvalvar pressure difference in closed position. Valve brands differed significantly from each other in the amount of hinge washing.

Quality of Life Among Patients With Congenital Heart Disease After Valve Replacement.

Most studies concerning valve replacement in congenital heart disease (CHD) focus on surgical morbidity and mortality. However, with the increased life expectancy of these patients, the focus shifts to quality of life (QOL). The aim of this study was to report and compare the QOL of CHD patients after valve replacement with the general population and to find factors associated with QOL. In a multicenter cross-sectional observational study of adults with CHD, QOL was measured with the RAND-36 questionnaire (a health-related QOL questionnaire, with 8 domains scoring from 0 to 100; higher scores indicate a better QOL). Functional status was measured with exercise capacity testing. Uni- and multivariable linear regression was used to find associations with QOL. In total, 324 patients with CHD and a prosthetic valve were included in this study. CHD patients with a valve replacement scored significantly lower than the general population on the general health, vitality, and social functioning domains (P < 0.05). On the bodily pain domain, they scored significantly higher (less pain) (P < 0.001). Higher NYHA class was associated with a lower QOL for all domains, reflecting the importance of functional capacity. Other variables related to aspects of QOL were age, gender, exercise capacity, and employment status. Adult patients with CHD and a prosthetic valve have lower scores on the QOL domains general health, vitality, and social functioning as compared to the general population. NYHA class was negatively associated with all QOL domains. Health care professionals should be aware of these patterns in counseling patients.

Mechanical valves in the pulmonary position: An international retrospective analysis.

OBJECTIVE: Life expectancy of patients with congenital heart disease has improved over the past decades, increasing the need for a durable pulmonary prosthetic valve. Biological valves in various forms have become the valve of choice for pulmonary valve replacement (PVR), but structural valve deterioration is unavoidable in the long term. Use of a mechanical valve could be an alternative, but data on long-term outcomes are sparse. METHODS: We retrospectively collected and analyzed data on 364 patients with mechanical valves implanted in the pulmonary position between 1965 and 2014. The data originate from medical centers in Barcelona (Spain), Graz (Austria), Groningen (the Netherlands), Munich (Germany), Rochester (United States), Seoul (Republic of Korea), and Tehran (Iran). RESULTS: Median follow-up duration was 4.26 years (range, 0-27 years), mean age at implantation was 27.16 ± 12.2 years. Tetralogy of Fallot was the most common primary cardiac diagnosis, with a subgroup of 69.8%. Freedom from valvular thrombosis was 91% (95% confidence interval [CI], 87%-94%) at 5 years and 86% (95% CI, 81%-91%) at 10 years post-PVR. With a success rate up to 88%, thrombolysis was a successful therapy. Freedom from reoperation was 97% (95% CI, 94%-99%) at 5 years post-PVR and 91% (95% CI, 85%-95%) at 10 years. CONCLUSIONS: Mechanical PVR is associated with a limited risk of valvular thrombosis. Thrombolysis was an effective treatment in the majority.