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The Journal of Invasive Cardiology Nov 2023Transcatheter edge-to-edge repair (TEER) using the MitraClip (Abbott Vascular) system has emerged as a standard treatment for patients with symptomatic severe secondary... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Transcatheter edge-to-edge repair (TEER) using the MitraClip (Abbott Vascular) system has emerged as a standard treatment for patients with symptomatic severe secondary or inoperable primary mitral regurgitation (MR). The relatively recent approval of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences) has expanded the options of TEER devices. However, evidence comparing PASCAL with MitraClip systems is still limited.
METHODS
We conducted a systematic literature research and meta-analysis in PubMed, Medline, and EMBASE databases for studies comparing PASCAL and MitraClip systems.
RESULTS
Four observational studies and 1 randomized controlled trial, involving 1315 patients total, were eligible for inclusion. All patients exhibited symptomatic (NYHA II-IV) MR grades 3+ or 4+. Baseline characteristics were comparable across all included studies. The clinical outcomes were assessed according to the Mitral Valve Academic Research Consortium consensus. The procedural success rates for the 2 devices were comparable in terms of achieving post-procedural MR grades of less than or equal to 2+ and less than or equal to 1+. Furthermore, most patients improved their clinical status, with no significant differences between patients treated with PASCAL and those treated with MitraClip. In terms of safety, both procedures exhibited low overall mortality rates and occurrence of major adverse events (MAE), without significant difference between the 2 devices. These findings remained consistent in both short- and long-term follow-up assessments.
CONCLUSIONS
Our study revealed similar effectiveness and safety profiles between the PASCAL and MitraClip devices in patients experiencing significant symptomatic MR.
Topics: Humans; Cardiac Catheterization; Cardiac Surgical Procedures; Catheters; Heart Valve Prosthesis Implantation; Mitral Valve; Mitral Valve Insufficiency; Treatment Outcome
PubMed: 37992330
DOI: 10.25270/jic/23.00218 -
Archives of Cardiovascular Diseases Dec 2023Leaflet thrombosis and reduced leaflet motion have become a concern with the expanding use of transcatheter aortic valve replacement in lower-risk patients. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Leaflet thrombosis and reduced leaflet motion have become a concern with the expanding use of transcatheter aortic valve replacement in lower-risk patients.
AIMS
To assess the proportions, predictors and clinical impact of leaflet thrombosis and reduced leaflet motion after transcatheter aortic valve replacement.
METHODS
We performed a meta-analysis of studies assessing the proportions of and/or clinical outcomes according to the presence of leaflet thrombosis after transcatheter aortic valve replacement identified with computed tomography and/or echocardiography.
RESULTS
Fifty-three studies, representing 25,258 patients undergoing transcatheter aortic valve replacement, were considered. The proportion of leaflet thrombosis was 5.2% overall, and was higher in computed tomography versus echocardiography (16.4% vs. 1.1%, respectively); reduced leaflet motion was identified in 11% of patients with four-dimensional computed tomography. Intra-annular bioprostheses were associated with a higher proportion of leaflet thrombosis, whereas chronic oral anticoagulation was protective for leaflet thrombosis in both computed tomography and echocardiographic studies (9.7% vs. 17.5%; relative risk [RR]: 0.51, 95% confidence interval [95% CI]: 0.37-0.71 and 0.9% vs. 2.7%; RR: 0.22, 95% CI: 0.06-0.79, respectively) and for reduced leaflet motion (2.5% vs. 12.4%; RR: 0.32, 95% CI: 0.13-0.76). Leaflet thrombosis was not associated with an increased risk of death, but with a higher risk of stroke in computed tomography studies (2.8% vs. 2.4%; RR: 1.63, 95% CI: 1.05-2.55), a difference more pronounced when considering reduced leaflet motion (3.5% vs. 1.7%; RR: 2.39, 95% CI: 0.63-8.34).
CONCLUSIONS
The proportion of leaflet thrombosis is highly variable according to the screening approach, the type of valve and the use of oral anticoagulation. The occurrence of cerebral events is increased when leaflet thrombosis and/or reduced leaflet motion are diagnosed, but leaflet thrombosis has no impact on survival.
Topics: Humans; Transcatheter Aortic Valve Replacement; Aortic Valve; Heart Valve Prosthesis; Thrombosis; Anticoagulants; Aortic Valve Stenosis; Treatment Outcome
PubMed: 37968182
DOI: 10.1016/j.acvd.2023.10.003 -
European Journal of Cardio-thoracic... Nov 2023Although the use of bioprostheses for mitral valve replacement (bMVR) is on the rise, their long-term durability is not well described. Defining bMVR durability will be...
OBJECTIVES
Although the use of bioprostheses for mitral valve replacement (bMVR) is on the rise, their long-term durability is not well described. Defining bMVR durability will be instrumental in setting the standard against which the performance of transcatheter mitral replacement is to be judged against. The authors of this systematic review aimed to identify, assess the quality and review the outcomes in studies reporting on long-term outcomes after bMVR published over the last 20 years.
METHODS
Medline, Embase and Cochrane CENTRAL were searched for studies that have reported outcomes beyond a minimum of 5 years of follow-up after bMVR. Cohort characteristics, definitions of structural valve deterioration (SVD) and outcomes were summarized. The risk of bias in included studies was assessed using the Cochrane QUIPS tool.
RESULTS
Twenty-one studies, including 15 833 patients, were identified. Sixty-four percent of all implants were porcine and the remaining bovine pericardial. Freedom from SVD at 10 years ranged from 58.9% to 100% and at 15 years from 58.3% to 93%. Freedom from reoperation ranged from 65% to 98.7% at 10 years and 78.5% to 91% at 15 years. Information on native valve pathology or dominant haemodynamic lesion was missing in 25% and 66% of studies, respectively. Reports of postoperative echocardiography were lacking, despite the heavy reliance on echocardiography for SVD diagnosis.
CONCLUSIONS
There is considerable variability in reporting bMVR long-term outcomes. As such, it is difficult to generate an unbiased, generalizable understanding of long- term outcomes after bMVR across the spectrum of mitral disease phenotypes.
Topics: Humans; Animals; Cattle; Swine; Heart Valve Prosthesis; Mitral Valve; Heart Valve Prosthesis Implantation; Bioprosthesis; Reoperation; Prosthesis Failure; Aortic Valve; Follow-Up Studies; Treatment Outcome
PubMed: 37963023
DOI: 10.1093/ejcts/ezad384 -
Heart Failure Reviews Jan 2024As the survival after heart transplantation (HTx) is steadily improving, an increasing number of patients with late cardiac pathologies such as valvular disease is... (Review)
Review
As the survival after heart transplantation (HTx) is steadily improving, an increasing number of patients with late cardiac pathologies such as valvular disease is expected to rise. Nevertheless, no guidelines for indication of redo cardiac surgery after HTx exists. The aim of the present systematic review is to describe the results reported in the literature of surgical management of severe aortic and/or mitral valve disease. A systematic review was conducted including studies reporting on adult patients with severe mitral or aortic valve pathology needing surgery after their previous HTx. Exclusion criteria consisted in surgery with no left heart valve surgery, concomitant valve surgery during heart transplant, transcatheter interventions, and heterotopic HTx. A total of 35 papers met our inclusion criteria out of 2755 potentially eligible studies with 44 mitral valve surgery patients and 20 aortic valve surgery patients. In the entire population, the mean time from HTx to reintervention was 6.19 ± 5.22 years. After a mean follow-up of 2.78 ± 3.54 years and 1.53 ± 2.26 years from reintervention, 65.6% mitral and 86.7% aortic patients were reported as alive, respectively. As guidelines on cardiac surgery after HTx are currently lacking, left-sided valvular cardiac reinterventions can be considered a possible therapeutic approach in carefully selected patients. These interventions may not only improve the patient's functional status and survival, but may ultimately reduce the need for re-transplantation due to the chronic shortage of donor hearts. However, the support of more robust data is warranted.
Topics: Adult; Humans; Heart Transplantation; Treatment Outcome; Tissue Donors; Heart Valve Diseases; Mitral Valve; Heart Diseases; Heart Valve Prosthesis Implantation
PubMed: 37950833
DOI: 10.1007/s10741-023-10368-5 -
Journal of Cardiothoracic Surgery Nov 2023Transcatheter mitral valve replacement (TMVR) using the Tendyne™ valve is regarded as one of the most studied TMVR systems. The first human experience with the... (Review)
Review
BACKGROUND
Transcatheter mitral valve replacement (TMVR) using the Tendyne™ valve is regarded as one of the most studied TMVR systems. The first human experience with the procedure was reported in 2013. The present study aims to systemically revise the published literature to document the global experience with TMVR using the Tendyne™ valve.
METHODS
The present review was conducted in line with the PRISMA statement on systematic reviews. Database included in the search process were Scopus, Web of Science and Pubmed. Search was processed using multiple keywords combinations and was adjusted to English literature only.
RESULTS
We included 26 articles in the final analysis reporting data from 319 patients. Patients recruited by the included studies comprised 192 males (60.2%) and 127 females (39.8%). In the studied patients, mitral annular calcification (MAC) was reported in 107 patients (33.5%). Preoperatively, MR grades 1,2 and 3-4 were reported in 3,5 and 307 patients respectively. Postoperatively, MR grades 1, 2 and 4 were reported in only 12, 3 and 1 patients respectively. Technical success was achieved in 309 patients (96.9%). Follow up durations widely varied among different studies from just days before discharge to 6 years. At the end of follow up, 79 patients died (24.8%) including 52 patients (16.3%) due to cardiovascular causes.
CONCLUSIONS
Management of mitral valve disease using the Tendyne system appears to be a promising minimally invasive option for many high-risk patients with accepted procedural feasibility and safety profile.
Topics: Male; Female; Humans; Mitral Valve; Heart Valve Prosthesis Implantation; Heart Valve Diseases; Heart Valve Prosthesis; Catheters; Treatment Outcome; Cardiac Catheterization; Mitral Valve Insufficiency
PubMed: 37950282
DOI: 10.1186/s13019-023-02446-4 -
Progress in Cardiovascular Diseases 2023Mitral valve transcatheter edge-to-edge repair (M-TEER) is a minimally invasive method for the treatment of mitral regurgitation (MR) in patients with prohibitive... (Meta-Analysis)
Meta-Analysis Review
Transcatheter edge-to-edge repair in mitral regurgitation: A comparison of device systems and recommendations for tailored device selection. A systematic review and meta-analysis.
BACKGROUND
Mitral valve transcatheter edge-to-edge repair (M-TEER) is a minimally invasive method for the treatment of mitral regurgitation (MR) in patients with prohibitive surgical risks. The traditionally used device, MitraClip, showed both safety and effectiveness in M-TEER. PASCAL is a newer device that has emerged as another feasible option to be used in this procedure.
METHODS
We searched for observational studies that compared PASCAL to MitraClip devices in M-TEER. The electronic databases searched for relevant studies were PubMed/MEDLINE, Scopus, and Embase. The primary outcomes were technical success and the grade of MR at follow-up. Secondary outcomes included all-cause mortality, bleeding, device success and reintervention.
RESULTS
Technical success (PASCAL: 96.5% vs MitraClip: 97.6%, p = 0.24) and MR ≤ 2 at 30-day follow-up (PASCAL: 89.4vs MitraClip 89.9%, p = 0.51) were comparable between both groups. Both devices showed similar outcomes including all-cause mortality (RR: 0.68 [0.34, 1.38]; P = 0.28), major bleeding (RR: 1.87 [0.68, 5.10]; P = 0.22) and reintervention (RR: 1.02 [0.33, 3.16]; P = 0.97). Device success was more frequent with PASCAL device (PASCAL: 86% vs MitraClip 68.5%; P = 0.44), however, the results did not reach statistical significance.
CONCLUSION
Clinical outcomes of PASCAL were comparable to those of MitraClip with no significant difference in safety and effectiveness. The choice between MitraClip and PASCAL devices should be guided by various factors, including mitral valve anatomy, etiology of regurgitation, and device-specific characteristics.
Topics: Humans; Mitral Valve Insufficiency; Treatment Outcome; Mitral Valve; Cardiac Surgical Procedures; Heart Valve Prosthesis Implantation; Cardiac Catheterization
PubMed: 37924965
DOI: 10.1016/j.pcad.2023.10.008 -
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 -
European Journal of Cardio-thoracic... Jan 2024Congenital supravalvular aortic stenosis (SVAS) is a rare form of congenital outflow tract obstruction and long-term outcomes are scarcely reported. This study aims to... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Congenital supravalvular aortic stenosis (SVAS) is a rare form of congenital outflow tract obstruction and long-term outcomes are scarcely reported. This study aims to provide an overview of outcomes after surgical repair for congenital SVAS.
METHODS
A systematic review of published literature was conducted, including observational studies reporting long-term clinical outcome (>2 years) after SVAS repair in children or adults considering >20 patients. Early risks, late event rates and time-to-event data were pooled and entered into a microsimulation model to estimate 30-year outcomes. Life expectancy was compared to the age-, sex- and origin-matched general population.
RESULTS
Twenty-three publications were included, encompassing a total of 1472 patients (13 125 patient-years; pooled mean follow-up: 9.0 (6.2) years; median follow-up: 6.3 years). Pooled mean age at surgical repair was 4.7 (5.8) years and the most commonly used surgical technique was the single-patch repair (43.6%). Pooled early mortality was 4.2% (95% confidence interval: 3.2-5.5%) and late mortality was 0.61% (95% CI: 0.45-0.83) per patient-year. Based on microsimulation, over a 30-year time horizon, it was estimated that an average patient with SVAS repair (mean age: 4.7 years) had an observed life expectancy that was 90.7% (95% credible interval: 90.0-91.6%) of expected life expectancy in the matched general population. The microsimulation-based 30-year risk of myocardial infarction was 8.1% (95% credible interval: 7.3-9.9%) and reintervention 31.3% (95% credible interval: 29.6-33.4%), of which 27.2% (95% credible interval: 25.8-29.1) due to repair dysfunction.
CONCLUSIONS
After surgical repair for SVAS, 30-year survival is lower than the matched-general-population survival and the lifetime risk of reintervention is considerable. Therefore, lifelong monitoring of the cardiovascular system and in particular residual stenosis and coronary obstruction is recommended.
Topics: Child; Adult; Humans; Child, Preschool; Aortic Stenosis, Supravalvular; Heart Valve Prosthesis Implantation; Reoperation; Constriction, Pathologic; Treatment Outcome; Aortic Valve Stenosis
PubMed: 37889257
DOI: 10.1093/ejcts/ezad360 -
BMC Cardiovascular Disorders Oct 2023To compare functional and health related quality of life outcomes post-transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in... (Meta-Analysis)
Meta-Analysis
Comparing functional and quality of life outcomes in transcatheter aortic valve implantation and surgical aortic valve replacement for aortic stenosis: a systematic review and meta-analysis.
BACKGROUND
To compare functional and health related quality of life outcomes post-transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in patients with critical aortic stenosis (AS) across low to high-risk surgical candidates. These patient-centred factors will be compared between both groups in the short to medium term time frames and will aid in shared decision making between patients and healthcare workers.
MATERIALS AND METHODS
We conducted a systematic review and meta-analysis of randomised controlled trials which compared TAVI with SAVR and reported on quality of life (QoL) and functional scores. The scores used were the Kansas City Cardiomyopathy Questionnaire (KCCQ), Euroqol-5DL (EQ5DL), the short form-36/12 (SF-36/12) and the NYHA.
RESULTS
We identified eight trials with a total of 8898 participants. Both groups showed improvements from baseline at one month. At one month there was a statistically significant difference in standardised mean difference (SMD) in favour of TAVI for EQ5DL (SMD 0.37, 95% CI 0.26,0.49), KCCQ (SMD 0.53,95% CI 0.48, 0.58), SF physical summary (SMD 0.55, 95% CI 0.31 - 0.78) and SF mental summary (SMD 0.34, 95% CI 0.27 - 0.40). At one year there was no statistically significant difference between any of these QoL metrics. For NYHA, no significant difference in odds ratio of class III/IV was observed at one month between TAVI and SAVR (OR 0.94, 95% CI 0.83, 1.07), however, TAVI was associated with reduced odds ratio of NYHA class I/II at one year (OR 0.87, 95% CI 0.78, 0.98).
CONCLUSION
Both groups were associated with improvements in QoL and functional outcomes with TAVI reporting more significant improvements in QoL at one-month post-procedures. No significant improvements between groups were seen at one year. This is the largest meta-analysis comparing post-operative health-related quality of life outcomes post SAVR and TAVI and has major implications in shared decision making for the treatment of aortic stenosis.
Topics: Humans; Transcatheter Aortic Valve Replacement; Aortic Valve; Quality of Life; Heart Valve Prosthesis Implantation; Treatment Outcome; Aortic Valve Stenosis; Risk Factors
PubMed: 37880616
DOI: 10.1186/s12872-023-03445-y -
International Journal of Antimicrobial... Jan 2024Adjunctive rifampicin for implant-associated infections is controversial. This study investigated the clinical outcomes of rifampicin combination therapy compared with... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Adjunctive rifampicin for implant-associated infections is controversial. This study investigated the clinical outcomes of rifampicin combination therapy compared with monotherapy in treating prosthetic joint infection (PJI) or prosthetic valve endocarditis (PVE) due to staphylococci and streptococci.
METHODS
A systematic search was performed from inception to 13 June 2022 in Embase, MEDLINE, Cochrane and Web of Science to investigate the clinical outcomes of rifampicin combination therapy compared with monotherapy in treating staphylococcal and streptococcal PJI or PVE. Randomised controlled trials (RCTs) and observational studies were included in the systematic review and meta-analysis.
RESULTS
Fourteen studies were included. A moderate quality of evidence was found in favour of rifampicin in patients with staphylococcal PJI who underwent a debridement, antibiotics and implant retention (DAIR) procedure [odds ratio = 2.49, 95% confidence interval (CI) 1.93-3.23]. Including the two RCTs only, adding rifampicin to the antibiotic regimen after DAIR was also in favour of rifampicin, but this was not statistically significant (risk ratio = 1.27, 95% CI 0.79-2.04; n = 126). Pooling data for patients with staphylococcal PJI who underwent a two-stage procedure showed that adding rifampicin was not associated with therapeutic success. Limited evidence was found for the use of rifampicin for PVE caused by staphylococci.
CONCLUSIONS
Adding rifampicin in the treatment of staphylococcal PJI treated by DAIR clearly increased the likelihood for therapeutic success. The clinical benefit of adjunctive rifampicin in the treatment of other staphylococci and streptococci implant-associated infections is still unclear.
Topics: Humans; Anti-Bacterial Agents; Arthritis, Infectious; Debridement; Prosthesis-Related Infections; Retrospective Studies; Rifampin; Staphylococcus; Streptococcus; Treatment Outcome
PubMed: 37875179
DOI: 10.1016/j.ijantimicag.2023.107015