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Biomaterials Science Apr 2024The sole effective treatment for most patients with heart valve disease is valve replacement by implantation of mechanical or biological prostheses. However, mechanical...
The sole effective treatment for most patients with heart valve disease is valve replacement by implantation of mechanical or biological prostheses. However, mechanical valves represent high risk of thromboembolism, and biological prostheses are prone to early degeneration. In this work, we aim to determine the potential of novel environmentally-friendly non-isocyanate polyurethanes (NIPUs) for manufacturing synthetic prosthetic heart valves. Polyhydroxyurethane (PHU) NIPUs are synthesized an isocyanate-free route, tested , and used to produce aortic valves. PHU elastomers reinforced with a polyester mesh show mechanical properties similar to native valve leaflets. These NIPUs do not cause hemolysis. Interestingly, both platelet adhesion and contact activation-induced coagulation are strongly reduced on NIPU surfaces, indicating low thrombogenicity. Fibroblasts and endothelial cells maintain normal growth and shape after indirect contact with NIPUs. Fluid-structure interaction (FSI) allows modeling of the ideal valve design, with minimal shear stress on the leaflets. Injection-molded valves are tested in a pulse duplicator and show ISO-compliant hydrodynamic performance, comparable to clinically-used bioprostheses. Poly(tetrahydrofuran) (PTHF)-NIPU patches do not show any evidence of calcification over a period of 8 weeks. NIPUs are promising sustainable biomaterials for the manufacturing of improved prosthetic valves with low thrombogenicity.
Topics: Humans; Polyurethanes; Isocyanates; Endothelial Cells; Heart Valve Prosthesis; Aortic Valve
PubMed: 38487997
DOI: 10.1039/d3bm01911j -
JACC. Cardiovascular Interventions Jan 2024There are limited data about postprocedural right heart reverse remodeling and long-term prosthesis durability after transcatheter pulmonary valve replacement (TPVR) and...
BACKGROUND
There are limited data about postprocedural right heart reverse remodeling and long-term prosthesis durability after transcatheter pulmonary valve replacement (TPVR) and how these compare to surgical pulmonary valve replacement (SPVR).
OBJECTIVES
This study sought to compare right heart reverse remodeling, pulmonary valve gradients, and prosthetic valve dysfunction after TPVR vs SPVR.
METHODS
Patients with TPVR were matched 1:2 to patients with SPVR based on age, sex, body surface area, congenital heart lesion, and procedure year. Right heart indexes (right atrial [RA] reservoir strain, RA volume index, RA pressure, right ventricular [RV] global longitudinal strain, RV end-diastolic area, and RV systolic pressure) were assessed at baseline (preintervention), 1 year postintervention, and 3 years postintervention. Pulmonary valve gradients were assessed at 1, 3, 5, 7, and 9 years postintervention.
RESULTS
There were 64 and 128 patients in the TPVR and SPVR groups, respectively. Among patients with TPVR, 46 (72%) and 18 (28%) received Melody (Medtronic) vs SAPIEN (Edwards Lifesciences) valves, respectively. The TPVR group had greater postprocedural improvement in RA reservoir strain and RV global longitudinal strain at 1 and 3 years. The TPVR group had a higher risk of prosthetic valve dysfunction mostly because of a higher incidence of prosthetic valve endocarditis compared to SPVR but a similar risk of pulmonary valve reintervention because some of the patients with endocarditis received medical therapy only. Both groups had similar pulmonary valve mean gradients at 9 years postintervention.
CONCLUSIONS
These data suggest a more favorable right heart outcome after TPVR. However, the risk of prosthetic valve endocarditis and prosthetic valve dysfunction remains a major concern.
Topics: Humans; Pulmonary Valve; Endocarditis, Bacterial; Heart Valve Prosthesis; Treatment Outcome; Endocarditis
PubMed: 38267139
DOI: 10.1016/j.jcin.2023.11.030 -
The Thoracic and Cardiovascular Surgeon Dec 2023Transcatheter aortic valve replacement (TAVR) for a degenerated surgical bioprosthesis (valve-in-valve [ViV]) has become an established procedure. Elevated gradients and...
BACKGROUND
Transcatheter aortic valve replacement (TAVR) for a degenerated surgical bioprosthesis (valve-in-valve [ViV]) has become an established procedure. Elevated gradients and patient-prosthesis mismatch (PPM) have previously been reported in mixed TAVR cohorts. We analyzed our single-center experience using the third-generation self-expanding Medtronic Evolut R prosthesis, with an emphasis on the incidence and outcomes of PPM.
METHODS
This is a retrospective analysis of prospectively collected data from our TAVR database. Intraprocedural and intrahospital outcomes are reported.
RESULTS
Eighty-six patients underwent ViV-TAVR with the Evolut R prosthesis. Mean age was 75.5 ± 9.5 years, 64% were males. The mean log EuroScore was 21.6 ± 15.7%. The mean time between initial surgical valve implantation and ViV-TAVR was 8.8 ± 3.2 years. The mean true internal diameter of the implanted surgical valves was 20.9 ± 2.2 mm. Post-AVR, 60% had no PPM, 34% had moderate PPM, and 6% had severe PPM. After ViV-TAVR, 33% had no PPM, 29% had moderate, and 39% had severe PPM. After implantation, the mean transvalvular gradient was reduced significantly from 36.4 ± 15.2 to 15.5 ± 9.1 mm Hg ( < 0.001). No patient had more than mild aortic regurgitation after ViV-TAVR. No conversion to surgery was necessary. Estimated Kaplan-Meier survival at 1 year for all patients was 87.4%. One-year survival showed no significant difference according to post-ViV PPM groups ( = 0.356).
CONCLUSION
ViV-TAVR using a supra-annular valve resulted in low procedural and in-hospital complication rates. However, moderate or severe PPM was common, with no influence on short-term survival. PPM may not be a suitable factor to predict survival after ViV-TAVR.
Topics: Male; Humans; Aged; Aged, 80 and over; Female; Aortic Valve; Heart Valve Prosthesis Implantation; Heart Valve Prosthesis; Aortic Valve Stenosis; Retrospective Studies; Incidence; Prosthesis Design; Treatment Outcome; Transcatheter Aortic Valve Replacement; Bioprosthesis
PubMed: 35255516
DOI: 10.1055/s-0042-1742755 -
Current Problems in Cardiology May 2024Transcatheter Aortic Valve Replacement (TAVR) marks a significant advancement in treating aortic stenosis (AS), especially for patients with high surgical risks. This... (Review)
Review
Transcatheter Aortic Valve Replacement (TAVR) marks a significant advancement in treating aortic stenosis (AS), especially for patients with high surgical risks. This concise review outlines TAVR's development, its broader application to include lower-risk patients, and innovations in the device and procedural technology. Clinical trials, notably the PARTNER series, affirm TAVR's efficacy, showing it matches or surpasses surgical aortic valve replacement (SAVR) in mortality reduction, hemodynamic benefits, and symptom alleviation, including heart failure. However, TAVR entails complications such as paravalvular leakage (PVL), conduction disorders, and increased cerebrovascular event risks. We evaluate these issues, their prevalence, causative factors, and clinical consequences, emphasizing improvements in valve design and technique that have significantly lowered PVL rates. The role of aortic valve anatomy and calcification in PVL and conduction issues is analyzed, underlining the necessity for meticulous patient selection and procedural planning. Further, the review delves into cerebrovascular event risks, their origins, and preventative strategies, including cerebral protection devices and the judicious use of anticoagulant and antiplatelet therapies. TAVR presents a less invasive, promising alternative to SAVR, but requires careful complication management to optimize patient results. Ongoing innovation and research are vital for advancing TAVR's techniques, improving valve designs, and extending its reach, thereby enhancing AS patients' quality of life.
Topics: Humans; Transcatheter Aortic Valve Replacement; Quality of Life; Treatment Outcome; Aortic Valve; Heart Valve Prosthesis Implantation; Heart Valve Prosthesis; Aortic Valve Stenosis; Risk Factors
PubMed: 38437930
DOI: 10.1016/j.cpcardiol.2024.102478 -
The American Journal of Cardiology Aug 2023
Topics: Humans; Aortic Valve; Heart Valve Prosthesis; Treatment Outcome; Heart Valve Prosthesis Implantation; Aortic Valve Stenosis; Retrospective Studies
PubMed: 37407390
DOI: 10.1016/j.amjcard.2023.06.060 -
Heart, Lung & Circulation Jan 2024Prosthetic valve endocarditis (PVE) is the most severe form of infective endocarditis associated with a high mortality rate. Whether PVE affects biological and... (Observational Study)
Observational Study
AIMS
Prosthetic valve endocarditis (PVE) is the most severe form of infective endocarditis associated with a high mortality rate. Whether PVE affects biological and mechanical aortic valves to the same extent remains controversial. This study aimed to compare the incidence of re-intervention because of PVE between bioprosthetic and mechanical valves.
METHODS
Patients undergoing isolated surgical aortic valve replacement (AVR) or combined AVR in a single cardiac surgery centre between January 1998 and December 2019 were analysed. All patients who underwent re-intervention because of PVE were identified. The primary endpoint was the rate of explants. Freedom from re-intervention and variables associated with re-intervention were analysed using Cox regression analysis including correction for competing risk.
RESULTS
During the study period, 5,983 aortic valve prostheses were implanted, including 3,620 biological (60.5%) and 2,363 mechanical (39.5%) prostheses. The overall mean follow-up period was 7.3±5.3 years (median, 6.5; IQR 2.9-11.2 years). The rate of re-intervention for PVE in the biological group was 1.5% (n=54) compared with 1.7% (n=40) in the mechanical group (p=0.541). Cox regression analysis revealed that younger age (HR 0.960, 95% CI 0.942-0.979; p<0.001), male sex (HR 2.362, 95% CI 1.384-4.033; p=0.002), higher creatinine (HR 1.002, 95% CI 0.999-1.004; p=0.057), and biological valve prosthesis (HR 2.073, 95% CI 1.258-3.414; p=0.004) were associated with re-intervention for PVE. After correction for competing risk of death, biological valve prosthesis was significantly associated with a higher rate of re-intervention for PVE (HR 2.011, 95% CI 1.177-3.437; p=0.011).
CONCLUSIONS
According to this single-centre, observational, retrospective cohort study, AVR using biological prosthesis is associated with re-intervention for PVE compared to mechanical prosthesis. Further investigations are needed to verify these findings.
Topics: Humans; Male; Aortic Valve; Heart Valve Prosthesis; Endocarditis, Bacterial; Retrospective Studies; Heart Valve Prosthesis Implantation; Endocarditis
PubMed: 38158265
DOI: 10.1016/j.hlc.2023.11.024 -
Circulation. Cardiovascular... Jul 2023In the SCOPE I trial (Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis), transcatheter aortic valve implantation with the... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
In the SCOPE I trial (Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis), transcatheter aortic valve implantation with the self-expanding ACURATE neo (NEO) did not meet noninferiority compared with the balloon-expandable SAPIEN 3 (S3) device regarding a composite end point at 30 days due to higher rates of prosthetic valve regurgitation and acute kidney injury. Data on long-term durability of NEO are scarce. Here, we report whether early differences between NEO and S3 translate into differences in clinical outcomes or bioprosthetic valve failure 3 years after transcatheter aortic valve implantation.
METHODS
Patients with severe aortic stenosis were randomized to transfemoral transcatheter aortic valve implantation with NEO or S3 at 20 European centers. Clinical outcomes at 3 years are compared using Cox proportional or Fine-Gray subdistribution hazard models by intention-to-treat. Bioprosthetic valve failure is reported for the valve-implant cohort.
RESULTS
Among 739 patients, 84 of 372 patients (24.3%) had died in the NEO and 85 of 367 (25%) in the S3 group at 3 years. Comparing NEO with S3, the 3-year rates of all-cause death (hazard ratio, 0.98 [95% CI, 0.73-1.33]), stroke (subhazard ratio, 1.04 [95% CI, 0.56-1.92]), and hospitalization for congestive heart failure (subhazard ratio, 0.74 [95% CI, 0.51-1.07]) were similar between the groups. Aortic valve reinterventions were required in 4 NEO and 3 S3 patients (subhazard ratio, 1.32 [95% CI, 0.30-5.85]). New York Heart Association functional class ≤II was observed in 84% (NEO) and 85% (S3), respectively. Mean gradients remained lower after NEO at 3 years (8 versus 12 mm Hg; <0.001).
CONCLUSIONS
Early differences between NEO and S3 did not translate into significant differences in clinical outcomes or bioprosthetic valve failure throughout 3 years.
REGISTRATION
URL: https://clinicaltrials.gov, Unique identifier: NCT03011346.
Topics: Humans; Aortic Valve; Aortic Valve Stenosis; Prosthesis Design; Heart Valve Prosthesis; Treatment Outcome; Transcatheter Aortic Valve Replacement
PubMed: 37417229
DOI: 10.1161/CIRCINTERVENTIONS.123.012873 -
Heart (British Cardiac Society) Dec 2023The effect of subclinical leaflet thrombosis, characterised by hypoattenuated leaflet thickening (HALT), on the valve haemodynamic function and durability of the... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
The effect of subclinical leaflet thrombosis, characterised by hypoattenuated leaflet thickening (HALT), on the valve haemodynamic function and durability of the bioprosthetic valve, is not yet determined. We determined the impact of HALT on valve haemodynamics after transcatheter aortic valve replacement (TAVR) and the predictors of haemodynamic structural valve deterioration (SVD).
METHODS
The Anticoagulation vs Dual Antiplatelet Therapy for Prevention of Leaflet Thrombosis and Cerebral Embolization after Transcatheter Aortic Valve Replacement(ADAPT-TAVR) trial is a multicenter, randomised trial that compared edoxaban and dual antiplatelet therapy in patients who had undergone successful TAVR. The presence of HALT was evaluated by four-dimensional CT at 6 months and serial echocardiography performed at baseline, immediately post-TAVR and after 6 months. SVD was defined as at least one of the following: (1) mean transprosthetic gradient ≥20 mm Hg, (2) change in the mean gradient ≥10 mm Hg from baseline, or (3) new or increase in intraprosthetic aortic regurgitation of at least ≥1 grade, resulting in moderate or greater regurgitation.
RESULTS
At 6 months, HALT was found in 30 of 211 (14.2%) patients. The presence of HALT did not significantly affect aortic valve mean gradients (with vs without HALT; 14.0±4.8 mm Hg vs 13.7±5.5 mm Hg; p=0.74) at 6 months. SVD was reported in 30 of 206 patients (14.6%) at 6-month follow-up echocardiography. Older age (OR: 1.138; 95% CI: 1.019 to 1.293; p=0.033), use of aortic valve size ≤23 mm (OR: 6.254; 95% CI: 2.230 to 20.569; p=0.001) and mean post-TAVR pressure gradient (OR: 1.233; 95% CI: 1.123 to 1.371; p<0.001) were independent predictors of haemodynamic SVD; however, the presence of HALT was not identified as a predictor of SVD.
CONCLUSIONS
In patients who had undergone successful TAVR, aortic valve haemodynamic status was not influenced by the presence of HALT. Although HALT was not a predictor of haemodynamic SVD at 6 months, it warrants further longer-term follow-up to evaluate the effect on long-term valve durability.
TRIAL REGISTRATION NUMBER
NCT03284827 (https://www.
CLINICALTRIALS
gov).
Topics: Humans; Transcatheter Aortic Valve Replacement; Aortic Valve Stenosis; Platelet Aggregation Inhibitors; Heart Valve Prosthesis; Aortic Valve; Hemodynamics; Thrombosis; Treatment Outcome
PubMed: 37586823
DOI: 10.1136/heartjnl-2023-322946 -
Heart (British Cardiac Society) Nov 2023Damage to the atrioventricular conduction axis continues to be a problem subsequent to transcatheter implantation of aortic valvar prostheses. Accurate knowledge of the... (Review)
Review
Damage to the atrioventricular conduction axis continues to be a problem subsequent to transcatheter implantation of aortic valvar prostheses. Accurate knowledge of the precise relationships of the conduction axis relative to the aortic root could greatly reduce the risk of such problems. Current diagrams highlighting these relationships rightly focus on the membranous septum. The current depictions, however, overlook a potentially important relationship between the superior fascicle of the left bundle branch and the nadir of the semilunar hinge of the right coronary leaflet of the aortic valve. Recent histological investigations demonstrate, in many instances, a very close relationship between the left bundle branch and the right coronary aortic leaflet. The findings also highlight two additional variable features, which can be revealed by clinical imaging. The first of these is the extent of an inferoseptal recess of the left ventricular outflow tract. The second is the extent of rotation of the aortic root within the base of the left ventricle. Much more of the conduction axis is within the confines of the circumference of the outflow tract when the root is rotated in counterclockwise fashion as assessed from the perspective of the imager, with this finding itself associated with a much narrower inferoseptal recess. A clear understanding of the marked variability within the aortic root is key to avoiding future problems with atrioventricular conduction.
Topics: Humans; Aorta, Thoracic; Aortic Valve; Heart Conduction System; Transcatheter Aortic Valve Replacement; Heart Valve Prosthesis Implantation; Heart Valve Prosthesis; Aortic Valve Stenosis; Treatment Outcome; Pacemaker, Artificial
PubMed: 37400231
DOI: 10.1136/heartjnl-2023-322716 -
Arquivos Brasileiros de Cardiologia Jul 2023
Topics: Humans; Transcatheter Aortic Valve Replacement; Aortic Valve; Aortic Valve Stenosis; Treatment Outcome; Heart Valve Prosthesis; Risk Factors; Heart Valve Prosthesis Implantation
PubMed: 37585898
DOI: 10.36660/abc.20230401