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Journal of the American Heart... Jan 2024Whether a bovine or porcine aortic valve bioprosthesis carries a higher risk of endocarditis after aortic valve replacement is unknown. The aim of this study was to...
BACKGROUND
Whether a bovine or porcine aortic valve bioprosthesis carries a higher risk of endocarditis after aortic valve replacement is unknown. The aim of this study was to compare the risk of prosthetic endocarditis in patients undergoing aortic valve replacement with a bovine versus porcine bioprosthesis.
METHODS AND RESULTS
This nationwide, population-based cohort study included all patients who underwent surgical aortic valve replacement with a bovine or porcine bioprosthesis in Sweden from 1997 to 2018. Regression standardization was used to account for intergroup differences. The primary outcome was prosthetic valve endocarditis, and the secondary outcomes were all-cause mortality and early prosthetic valve endocarditis. During a maximum follow-up time of 22 years, we included 21 022 patients, 16 603 with a bovine valve prosthesis and 4419 with a porcine valve prosthesis. The mean age was 73 years, and 61% of the patients were men. In total, 910 patients were hospitalized for infective endocarditis: 690 (4.2%) in the bovine group and 220 (5.0%) in the porcine group. The adjusted cumulative incidence of prosthetic valve endocarditis at 15 years was 9.5% (95% CI, 6.2%-14.4%) in the bovine group and 2.8% (95% CI, 1.4%-5.6%) in the porcine group. The absolute risk difference between the groups at 15 years was 6.7% (95% CI, 0.8%-12.5%).
CONCLUSIONS
The risk of endocarditis was higher in patients who received a bovine compared with a porcine valve prosthesis after surgical aortic valve replacement. This association should be considered in patients undergoing both surgical and transcatheter aortic valve replacement.
Topics: Male; Humans; Animals; Cattle; Swine; Aged; Female; Aortic Valve; Heart Valve Prosthesis; Bioprosthesis; Endocarditis, Bacterial; Cohort Studies; Endocarditis; Heart Valve Prosthesis Implantation
PubMed: 38156596
DOI: 10.1161/JAHA.123.031387 -
Journal of the American Heart... Oct 2023Background Limited data are available about clinical outcomes and residual mitral regurgitation (MR) after transcatheter edge-to-edge repair in the large Asian-Pacific...
One-Year Outcomes and Their Relationship to Residual Mitral Regurgitation After Transcatheter Edge-to-Edge Repair With MitraClip Device: Insights From the OCEAN-Mitral Registry.
Background Limited data are available about clinical outcomes and residual mitral regurgitation (MR) after transcatheter edge-to-edge repair in the large Asian-Pacific cohort. Methods and Results From the Optimized Catheter Valvular Intervention (OCEAN-Mitral) registry, a total of 2150 patients (primary cause of 34.6%) undergoing transcatheter edge-to-edge repair were analyzed and classified into 3 groups according to the residual MR severity at discharge: MR 0+/1+, 2+, and 3+/4+. The mortality and heart failure hospitalization rates at 1 year were 12.3% and 15.0%, respectively. Both MR and symptomatic improvement were sustained at 1 year with MR ≤2+ in 94.1% of patients and New York Heart Association functional class I/II in 95.0% of patients. Compared with residual MR 0+/1+ (20.4%) at discharge, both residual MR 2+ (30.2%; < 0.001) and 3+/4+ (32.4%; = 0.007) were associated with the higher incidence of death or heart failure hospitalization (adjusted hazard ratio [HR], 1.59; < 0.001, and adjusted HR, 1.73; = 0.008). New York Heart Association class III/IV at 1 year was more common in the MR 3+/4+ group (20.0%) than in the MR 0+/1+ (4.6%; < 0.001) and MR 2+ (6.4%; < 0.001) groups, and the proportion of New York Heart Association class I is significantly higher in the MR 1+ group (57.8%) than in the MR 2+ group (48.3%; = 0.02). Conclusions The OCEAN-Mitral registry demonstrated favorable clinical outcomes and sustained MR reduction at 1 year in patients undergoing transcatheter edge-to-edge repair. Both residual MR 2+ and 3+/4+ after transcatheter edge-to-edge repair at discharge were associated with worse clinical outcomes compared with residual MR 0+/1+. Registration Information https://upload.umin.ac.jp. Identifier: UMIN000023653.
Topics: Humans; Mitral Valve Insufficiency; Mitral Valve; Heart Valve Prosthesis Implantation; Heart Valve Prosthesis; Risk Factors; Treatment Outcome; Cardiac Catheterization; Hemodynamics; Heart Failure; Registries
PubMed: 37815039
DOI: 10.1161/JAHA.123.030747 -
The Journal of Invasive Cardiology Feb 2024The SavvyWire(OpSens Medical) is a support wire for transcatheter aortic valve replacement (TAVR) procedures that, in addition to its dedicated left ventricle (LV)... (Observational Study)
Observational Study
OBJECTIVES
The SavvyWire(OpSens Medical) is a support wire for transcatheter aortic valve replacement (TAVR) procedures that, in addition to its dedicated left ventricle (LV) pacing capabilities, has a distal pressure sensor that measures live transvalvular hemodynamics during the procedure. We aimed to determine the safety, efficacy, and functionality of the SavvyWire during TAVR procedures in an all-comer population.
METHODS
We performed a multicentric, prospective, observational, single-arm, all-comers registry of patients with symptomatic, severe aortic stenosis undergoing TAVR in 3 Canadian centers. Data were collected in a dedicated database, and pre-specified questionnaires were fulfilled by the heart team implanters after each procedure.
RESULTS
A total of 60 patients were included (mean age: 78.6 ± 7.2 years; 51% women; mean Society of Thoracic Surgeons score: 2.2 ± 1.6%). TAVR was performed through a transfemoral approach in 90% of cases, and balloon- and self-expandable valves were used in 73% and 27% of patients, respectively. There were no cases of LV perforation, guidewire deformation, significant loss of capture, or major software malfunction. The rate of successful delivery of the TAVR system was 100%, and effective LV pacing was achieved in 98% of patients. The pre-TAVR mean gradient was 39 ± 14 mm Hg while the final post-TAVR gradient was 8 ± 5 mm Hg; the mean aortic systolic pressure during rapid pacing was 54 ± 12 mm Hg. In 97% of the TAVR procedures, SavvyWire's functionality was reported to be better or similar to other TAVR workhorse support wires.
CONCLUSIONS
SavvyWire was safe, effective, and functional for live transvalvular hemodynamic evaluation and rapid pacing during TAVR procedures. More studies with larger sample sizes and comparison against different wires and gradient measurement methods are warranted.
Topics: Aged; Aged, 80 and over; Female; Humans; Male; Aortic Valve; Aortic Valve Stenosis; Canada; Heart Valve Prosthesis; Hemodynamics; Prospective Studies; Prosthesis Design; Risk Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 38335504
DOI: 10.25270/jic/23.00242 -
Journal of the American Heart... Jul 2023Background The incidence and implications of worsening renal function (WRF) after mitral valve transcatheter edge-to-edge repair (TEER) in patients with heart failure... (Randomized Controlled Trial)
Randomized Controlled Trial
Background The incidence and implications of worsening renal function (WRF) after mitral valve transcatheter edge-to-edge repair (TEER) in patients with heart failure (HF) are unknown. Therefore, the aim of this study was to determine the proportion of patients with HF and secondary mitral regurgitation who develop persistent WRF within 30 days following TEER, and whether this development portends a worse prognosis. Methods and Results In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial, 614 patients with HF and severe secondary mitral regurgitation were randomized to TEER with the MitraClip plus guideline-directed medical therapy (GDMT) versus GDMT alone. WRF was defined as serum creatinine increase ≥1.5× or ≥0.3 mg/dL from baseline persisting to day 30 or requiring renal replacement therapy. All-cause death and HF hospitalization rates between 30 days and 2 years were compared in patients with and without WRF. WRF at 30 days was present in 11.3% of patients (9.7% in the TEER plus GDMT group and 13.1% in the GDMT alone group; =0.23). WRF was associated with all-cause death (hazard ratio [HR], 1.98 [95% CI, 1.3-3.03]; =0.001) but not HF hospitalization (HR, 1.47 [ 95% CI, 0.97-2.24]; =0.07) between 30 days and 2 years. Compared with GDMT alone, TEER reduced both death and HF hospitalization consistently in patients with and without WRF (=0.53 and 0.57, respectively). Conclusions Among patients with HF and severe secondary mitral regurgitation, the incidence of WRF at 30 days was not increased after TEER compared with GDMT alone. WRF was associated with greater 2-year mortality but did not attenuate the treatment benefits of TEER in reducing death and HF hospitalization compared with GDMT alone. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01626079.
Topics: Humans; Mitral Valve Insufficiency; Incidence; Heart Failure; Prognosis; Kidney; Treatment Outcome; Heart Valve Prosthesis Implantation
PubMed: 37421291
DOI: 10.1161/JAHA.123.029504 -
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 -
Anatolian Journal of Cardiology Nov 2023Perfect heart valve prostheses have optimized hemodynamics, reduced surgical morbidity, long-lasting durability, and extended patient survival with greater quality of... (Review)
Review
BACKGROUND
Perfect heart valve prostheses have optimized hemodynamics, reduced surgical morbidity, long-lasting durability, and extended patient survival with greater quality of life. Mechanical valves are recommended; however, young children may need anticoagulant medication for life. In this study, we looked at the success rate and viability of aortic valve neocuspidization (AVNeo) surgery for a variety of aortic disorders.
METHODS
A methodical search strategy was used to fully evaluate the AVNeo results. Boolean operators were used to combine important words like 'Ozaki Procedure,' 'Aortic Valve Neocuspidization,' 'AVNeo,' and associated terms. Reputable databases such as PubMed, MEDLINE, Embase, Web of Science, and Scopus were the focus of our search. Study quality was assessed using a critical evaluation created with the Critical Appraisal Skills Programme tool.
RESULTS
The findings are summarized in the 'Results' section that contains descriptive and critical analysis, ramifications, and explanations. According to research, AVNeo improved valve function and had few side effects. Aortic valve neocuspidization has a lower mean pressure gradient and a larger mean efficient orifice area than Trifecta. Aortic valve neocuspidization surgery reduces aortic valve regurgitation and pressure gradients. Postoperative echocardiograms indicated a decrease in peak and a rise in mean pressure gradient.
CONCLUSION
The Ozaki method restores a healthy laminar flow pattern while preventing bivalvular disease. Ozaki procedure should be explored for valve repair in infants with truncal valve and congenital aortic disease. Aortic valve tricuspidization with glutaraldehyde-treated autologous pericardium results in considerable effective orifice area, modest pressure gradients, and little regurgitation.
Topics: Child; Humans; Child, Preschool; Aortic Valve; Quality of Life; Aortic Valve Stenosis; Aortic Valve Insufficiency; Heart Valve Prosthesis; Pericardium; Aortic Diseases; Treatment Outcome
PubMed: 37909351
DOI: 10.14744/AnatolJCardiol.2023.3477 -
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 -
The American Journal of Cardiology Oct 2023Patients with mechanical aortic valve replacement (AVR) require lifelong vitamin K antagonist (VKA) therapy for stroke and systemic embolism prevention. However, VKA...
Patients with mechanical aortic valve replacement (AVR) require lifelong vitamin K antagonist (VKA) therapy for stroke and systemic embolism prevention. However, VKA treatment predisposes patients to various types of bleeding. In the present study, we sought to assess the success of antithrombotic therapy and the occurrence and timing of strokes and bleeding events after mechanical AVR. A total of 308 patients who underwent isolated mechanical AVR were included in the study, and follow-up data were completed for 306 patients (99.4%). The median follow-up time was 7.3 (interquartile range 4.2 to 10.9) years. The risk for major bleeding was 5-fold compared with major stroke (6.2% vs 1.3% and 20.9% vs 4.0%, respectively; events rates 3.1 vs 0.5 per 100 patient-years, respectively) at 30-day and long-term follow-up, indicating good efficacy but inadequate safety of stroke prevention. At the time of the early postoperative major bleeding, the international normalized ratio was under the therapeutic range in 73.7% of the patients. However, most patients were on triple antithrombotic treatment consisting of subcutaneous enoxaparin, VKA, and a tail effect of discontinued aspirin. During the long-term follow-up, the most common site of bleeding was gastrointestinal (41.7%), followed by genitourinary bleeding (23.3%) and intracranial hemorrhage (18.3%). Furthermore, mortality was relatively high, with a 10-year survival estimate of 78.3%. In conclusion, although ischemic stroke is a well-identified adverse event after mechanical AVR, it seems that major bleeding is a frequent clinically relevant complication during perioperative and long-term follow-up. This finding underscores the recognition and management of modifiable bleeding risk factors.
Topics: Humans; Aortic Valve; Fibrinolytic Agents; Stroke; Aspirin; Anticoagulants; Heart Valve Prosthesis; Postoperative Hemorrhage; Heart Valve Prosthesis Implantation; Treatment Outcome
PubMed: 37544143
DOI: 10.1016/j.amjcard.2023.07.097 -
Journal of Thrombosis and Haemostasis :... Sep 2023Prosthetic heart valves are the only treatment for most patients with severe valvular heart disease. Mechanical valves, made of metallic components, are the most...
BACKGROUND
Prosthetic heart valves are the only treatment for most patients with severe valvular heart disease. Mechanical valves, made of metallic components, are the most long-lasting type of replacement valves. However, they are prone to thrombosis and require permanent anticoagulation and monitoring, which leads to higher risk of bleeding and impacts the patient's quality of life.
OBJECTIVES
To develop a bioactive coating for mechanical valves with the aim to prevent thrombosis and improve patient outcomes.
METHODS
We used a catechol-based approach to produce a drug-releasing multilayer coating adherent to mechanical valves. The hemodynamic performance of coated Open Pivot valves was verified in a heart model tester, and coating durability in the long term was assessed in a durability tester producing accelerated cardiac cycles. Coating antithrombotic activity was evaluated in vitro with human plasma or whole blood under static and flow conditions and in vivo after surgical valve implantation in a pig's thoracic aorta.
RESULTS
We developed an antithrombotic coating consisting of ticagrelor- and minocycline-releasing cross-linked nanogels covalently linked to polyethylene glycol. We demonstrated the hydrodynamic performance, durability, and hemocompatibility of coated valves. The coating did not increase the contact phase activation of coagulation, and it prevented plasma protein adsorption, platelet adhesion, and thrombus formation. Implantation of coated valves in nonanticoagulated pigs for 1 month efficiently reduced valve thrombosis compared with noncoated valves.
CONCLUSION
Our coating efficiently inhibited mechanical valve thrombosis, which might solve the issues of anticoagulant use in patients and the number of revision surgeries due to valve thrombosis despite anticoagulation.
Topics: Humans; Animals; Swine; Fibrinolytic Agents; Quality of Life; Thrombosis; Heart Valve Diseases; Heart Valve Prosthesis; Anticoagulants; Heart Valves
PubMed: 37196847
DOI: 10.1016/j.jtha.2023.05.004 -
Current Problems in Cardiology Oct 2023Many questions were raised due to the divergent results between cardiovascular outcomes assessment of the MitraClip percutaneous therapy for heart failure patients with... (Review)
Review
Many questions were raised due to the divergent results between cardiovascular outcomes assessment of the MitraClip percutaneous therapy for heart failure patients with functional mitral regurgitation (COAPT) and multicenter study of percutaneous mitral valve Repair MitraClip device in patients with severe secondary mitral regurgitation (MITRA-FR) trials on the use of percutaneous mitral valve repair for secondary mitral regurgitation. This paper examined pooled patients' characteristics and outcomes from real-life experience compared with those in the 2 landmark trials. A comprehensive search identified eligible studies published in 2020 and 2021. Mean difference and odds ratio (OR) were used to compare continuous and categorical data. Thirty-three studies included more than 9200 patients. Patients in landmark trials were younger than in real-life, less likely to present with severe heart failure symptoms ([COAPT: OR 0.25; 95% CI: 0.21, 0.31]; [MITRA-FR: OR 0.32; 95% CI: 0.23, 0.45]) or severe mitral regurgitation grade (COAPT only: OR 0.57; 95% CI: 0.45, 0.71) with larger left ventricular end diastolic volume. Procedure success (OR 1.94; 95% CI: 1.10, 3.40) was more frequent with lower all-cause mortality (OR 0.73; 95% CI: 0.54, 0.99) in COAPT. Real-life patients experienced more favorable procedural and clinical outcomes compared with MITRA-FR patients. Real-life data on percutaneous mitral valve repair in secondary mitral regurgitation showed important variations in patient selection and procedural outcomes. Rates of death and heart failure hospitalization in observational studies were lower than MITRA-FR but higher than COAPT trial.
Topics: Humans; Mitral Valve Insufficiency; Mitral Valve; Treatment Outcome; Heart Valve Prosthesis Implantation; Heart Failure; Multicenter Studies as Topic
PubMed: 37336309
DOI: 10.1016/j.cpcardiol.2023.101889