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The American Journal of Cardiology Nov 2023This systematic review and meta-analysis aimed to investigate whether percutaneous mitral valve repair (PMVr) using MitraClip was more effective than surgery or medical... (Meta-Analysis)
Meta-Analysis Review
This systematic review and meta-analysis aimed to investigate whether percutaneous mitral valve repair (PMVr) using MitraClip was more effective than surgery or medical therapy for long-term morbidity and mortality. We searched MEDLINE, EMBASE, and CENTRAL (Cochrane Library) databases to identify relevant studies that recruited adult patients with functional or secondary mitral valve regurgitation who underwent PMVr with MitraClip implantation using appropriate search terms and Boolean operators. The odds ratios (ORs) were pooled using the random-effects model. A total of 14 studies recruiting 2,593 patients were included. Within 12 months of follow-up, patients who underwent PMVr did not maintain mitral valve regurgitation grade 2+ (OR 0.22, 95% confidence interval [CI] 0.12 to 0.41, p <0.0001, I = 0.0%, p = 0.52) or symptom-free heart failure (OR 0.47, 95% CI 0.29 to 0.77, p = 0.0028, I = 0.0%, p = 0.66) compared with their surgical counterparts. Patients were more likely to be rehospitalized for heart failure (OR 2.79, 95% CI 1.54 to 5.05, p = 0.0007, I = 0.0%, p = 0.51). However, there was no difference between the groups in terms of all-cause or cardiovascular mortality. Whereas, in comparison with medical therapy, PMVr significantly reduced all-cause mortality at 12 and ≥24 months of follow-up (OR 0.41, 95% CI 0.24, 0.69, p = 0.0009, I = 32%, p = 0.23 and OR 0.55, 95% CI 0.40, 0.75, p = 0.0002, I = 0.0%, p = 0.45, respectively). In conclusion, there was no difference in all-cause death at 12 or 24 months of follow-up between PMVr and the surgical approach, but the durability of valvular repair was inferior with PMVr. In comparison with medical therapy, there was a significant reduction in mortality with PMVr.
Topics: Adult; Humans; Mitral Valve Insufficiency; Mitral Valve; Treatment Outcome; Cardiac Surgical Procedures; Heart Failure; Heart Valve Prosthesis Implantation
PubMed: 37741106
DOI: 10.1016/j.amjcard.2023.08.097 -
European Journal of Cardio-thoracic... Sep 2023To support clinical decision-making in children with aortic valve disease, by compiling the available evidence on outcome after paediatric aortic valve repair (AVr). (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To support clinical decision-making in children with aortic valve disease, by compiling the available evidence on outcome after paediatric aortic valve repair (AVr).
METHODS
A systematic review of literature reporting clinical outcome after paediatric AVr (mean age at surgery <18 years) published between 1 January 1990 and 23 December 2021 was conducted. Early event risks, late event rates and time-to-event data were pooled. A microsimulation model was employed to simulate the lives of individual children, infants and neonates following AVr.
RESULTS
Forty-one publications were included, encompassing 2 623 patients with 17 217 patient-years of follow-up (median follow-up: 7.3 years; range: 1.0-14.4 years). Pooled mean age during repair for aortic stenosis in children (<18 years), infants (<1 year) or neonates (<30 days) was 5.2 ± 3.9 years, 35 ± 137 days and 11 ± 6 days, respectively. Pooled early mortality after stenosis repair in children, infants and neonates, respectively, was 3.5% (95% confidence interval: 1.9-6.5%), 7.4% (4.2-13.0%) and 10.7% (6.8-16.9%). Pooled late reintervention rate after stenosis repair in children, infants and neonates, respectively, was 3.31%/year (1.66-6.63%/year), 6.84%/year (3.95-11.83%/year) and 6.32%/year (3.04-13.15%/year); endocarditis 0.07%/year (0.03-0.21%/year), 0.23%/year (0.07-0.71%/year) and 0.49%/year (0.18-1.29%/year); and valve thrombosis 0.05%/year (0.01-0.26%/year), 0.15%/year (0.04-0.53%/year) and 0.19%/year (0.05-0.77%/year). Microsimulation-based mean life expectancy in the first 20 years for children, infants and neonates with aortic stenosis, respectively, was 18.4 years (95% credible interval: 18.1-18.7 years; relative survival compared to the matched general population: 92.2%), 16.8 years (16.5-17.0 years; relative survival: 84.2%) and 15.9 years (14.8-17.0 years; relative survival: 80.1%). Microsimulation-based 20-year risk of reintervention in children, infants and neonates, respectively, was 75.2% (72.9-77.2%), 53.8% (51.9-55.7%) and 50.8% (47.0-57.6%).
CONCLUSIONS
Long-term outcomes after paediatric AVr for stenosis are satisfactory and dependent on age at surgery. Despite a high hazard of reintervention for valve dysfunction and slightly impaired survival relative to the general population, AVr is associated with low valve-related event occurrences and should be considered in children with aortic valve disease.
Topics: Infant, Newborn; Humans; Child; Infant; Adolescent; Aortic Valve; Heart Valve Prosthesis Implantation; Heart Valve Prosthesis; Constriction, Pathologic; Aortic Valve Stenosis; Treatment Outcome; Retrospective Studies; Reoperation
PubMed: 37584683
DOI: 10.1093/ejcts/ezad284 -
Tricuspid valve repair concomitant with mitral valve surgery: a systematic review and meta-analysis.International Journal of Surgery... Jul 2023Uncertainties persist about whether to aggressively and effectively treat tricuspid regurgitation (TR) during mitral valve (MV) surgery. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Uncertainties persist about whether to aggressively and effectively treat tricuspid regurgitation (TR) during mitral valve (MV) surgery.
REVIEW METHODS
Systematic literature searches were performed in five databases to collect all relevant studies published before May 2022 on whether the tricuspid valve was treated during MV surgery. Separate meta-analyses were performed on data from unmatched studies and randomized controlled trials (RCT)/adjusted studies.
MAIN RESULTS
A total of 44 publications were included, of which eight were RCT studies and the rest were retrospective studies. There was no difference in 30-day mortality [odds ratio (OR): 1.00, 95% CI: 0.71-1.42, OR: 0.66, 95% CI: 0.30-1.41)] or overall survival [hazard ratio (HR): 1.01, 95% CI: 0.85-1.19, HR: 0.77, 95% CI: 0.52-1.14] in unmatched studies and RCT/adjusted studies. Late mortality (OR: 0.37, 95% CI: 0.21-0.64) and cardiac-related mortality (OR: 0.36, 95% CI: 0.21-0.62) were lower in the tricuspid valve repair (TVR) group in the RCT/adjusted studies. In the unmatched studies, overall cardiac mortality (OR: 0.48, 95% CI: 0.26-0.88) was lower in the TVR group. In the late TR progression analysis, the late TR progression was lower among patients in the concomitantly intervened tricuspid group, and patients in the untreated tricuspid group were prone to TR progression in both studies (HR: 0.30, 95% CI: 0.22-0.41, HR: 0.37, 95% CI: 0.23-0.58).
CONCLUSIONS
TVR concomitant with MV surgery is most effective in patients with significant TR and dilated tricuspid annulus, especially those with a significantly reduced risk of distant TR progression.
Topics: Humans; Tricuspid Valve; Mitral Valve; Mitral Valve Insufficiency; Treatment Outcome; Heart Valve Prosthesis Implantation; Tricuspid Valve Insufficiency; Retrospective Studies
PubMed: 37300887
DOI: 10.1097/JS9.0000000000000396 -
European Heart Journal Sep 2023To support decision-making in children undergoing aortic valve replacement (AVR), by providing a comprehensive overview of published outcomes after paediatric AVR, and... (Meta-Analysis)
Meta-Analysis
AIMS
To support decision-making in children undergoing aortic valve replacement (AVR), by providing a comprehensive overview of published outcomes after paediatric AVR, and microsimulation-based age-specific estimates of outcome with different valve substitutes.
METHODS AND RESULTS
A systematic review of published literature reporting clinical outcome after paediatric AVR (mean age <18 years) published between 1/1/1990 and 11/08/2021 was conducted. Publications reporting outcome after paediatric Ross procedure, mechanical AVR (mAVR), homograft AVR (hAVR), and/or bioprosthetic AVR were considered for inclusion. Early risks (<30d), late event rates (>30d) and time-to-event data were pooled and entered into a microsimulation model. Sixty-eight studies, of which one prospective and 67 retrospective cohort studies, were included, encompassing a total of 5259 patients (37 435 patient-years; median follow-up: 5.9 years; range 1-21 years). Pooled mean age for the Ross procedure, mAVR, and hAVR was 9.2 ± 5.6, 13.0 ± 3.4, and 8.4 ± 5.4 years, respectively. Pooled early mortality for the Ross procedure, mAVR, and hAVR was 3.7% (95% CI, 3.0%-4.7%), 7.0% (5.1%-9.6%), and 10.6% (6.6%-17.0%), respectively, and late mortality rate was 0.5%/year (0.4%-0.7%/year), 1.0%/year (0.6%-1.5%/year), and 1.4%/year (0.8%-2.5%/year), respectively. Microsimulation-based mean life-expectancy in the first 20 years was 18.9 years (18.6-19.1 years) after Ross (relative life-expectancy: 94.8%) and 17.0 years (16.5-17.6 years) after mAVR (relative life-expectancy: 86.3%). Microsimulation-based 20-year risk of aortic valve reintervention was 42.0% (95% CI: 39.6%-44.6%) after Ross and 17.8% (95% CI: 17.0%-19.4%) after mAVR.
CONCLUSION
Results of paediatric AVR are currently suboptimal with substantial mortality especially in the very young with considerable reintervention hazards for all valve substitutes, but the Ross procedure provides a survival benefit over mAVR. Pros and cons of substitutes should be carefully weighed during paediatric valve selection.
Topics: Humans; Child; Adolescent; Aortic Valve; Heart Valve Prosthesis Implantation; Retrospective Studies; Prospective Studies; Heart Valve Prosthesis; Treatment Outcome
PubMed: 37366156
DOI: 10.1093/eurheartj/ehad370 -
Journal of Cardiothoracic Surgery Mar 2024The Cabrol procedure has undergone various modifications and developments since its invention. However, there is a notable gap in the literature regarding meta-analyses... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The Cabrol procedure has undergone various modifications and developments since its invention. However, there is a notable gap in the literature regarding meta-analyses assessing it.
METHODS
A systematic review and meta-analysis was conducted to evaluate the effectiveness and long-term outcomes of the Cabrol procedure and its modifications. Pooling was conducted using random effects model. Outcome events were reported as linearized occurrence rates (percentage per patient-year) with 95% confidence intervals.
RESULTS
A total of 14 studies involving 833 patients (mean age: 50.8 years; 68.0% male) were included in this meta-analysis. The pooled all-cause early mortality was 9.0% (66 patients), and the combined rate of reoperation due to bleeding was 4.9% (17 patients). During the average 4.4-year follow-up (3,727.3 patient-years), the annual occurrence rates (linearized) for complications were as follows: 3.63% (2.79-4.73) for late mortality, 0.64% (0.35-1.16) for aortic root reoperation, 0.57% (0.25-1.31) for hemorrhage events, 0.66% (0.16-2.74) for thromboembolism, 0.60% (0.29-1.26) for endocarditis, 2.32% (1.04-5.16) for major valve-related adverse events, and 0.58% (0.34-1.00) for Cabrol-related coronary graft complications.
CONCLUSION
This systematic review provides evidence that the outcomes of the Cabrol procedure and its modifications are acceptable in terms of mortality, reoperation, anticoagulation, and valve-related complications, especially in Cabrol-related coronary graft complications. Notably, the majority of Cabrol procedures were performed in reoperations and complex cases. Furthermore, the design and anastomosis of the Dacron interposition graft for coronary reimplantation, considering natural anatomy and physiological hemodynamics, may promise future advancements in this field.
Topics: Humans; Male; Middle Aged; Female; Blood Vessel Prosthesis; Aortic Valve; Aorta; Heart Valve Prosthesis; Reoperation; Heart Diseases
PubMed: 38532449
DOI: 10.1186/s13019-024-02642-w -
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 -
Journal of Cardiothoracic Surgery Nov 2023The aim of this review was the creation of uniform protocols to carry out and disclose First-In-Human and preliminary clinical trials of biological mitral valve... (Review)
Review
BACKGROUND
The aim of this review was the creation of uniform protocols to carry out and disclose First-In-Human and preliminary clinical trials of biological mitral valve replacement. The need for consistent methodology in these early trials was highlighted by the observation of significant variability in the methods and protocols used across different research.
METHODS
An extensive search through six major databases was carried out to retrieve First-In-Human (FIH) clinical studies evaluating surgically implanted bio-prostheses in the mitral position.
RESULTS
Following the PRISMA guideline, a systematic search identified 2082 published articles until March 2023. After removing duplicates (189), 1862 citations were screened, resulting in 22 eligible studies with 3332 patients for analysis. The mitral valve prostheses in these studies ranged from 21 to 37 mm, with the 29 mm size being most prevalent. Patient numbers varied, with the FIH subgroup including 31 patients and the older subgroup including 163 patients. Average study durations differed: the older subgroup lasted 4.57 years, the FIH subgroup 2.85 years, and the early phase studies spanned 8.05 years on average.
CONCLUSION
FIH clinical report is essential to assess the significance of clinical data required for a "de novo" surgical implant. In addition, understanding the performance of the device, and recognizing the difficulties associated with the innovation constitute important lessons. These insights could be beneficial for the development of bioprosthetic heart valves and formulating a protocol for an FIH clinical trial.
Topics: Humans; Mitral Valve; Prosthesis Design; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Bioprosthesis; Prosthesis Failure
PubMed: 38037117
DOI: 10.1186/s13019-023-02464-2 -
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 -
Open Heart Aug 2023Assessment of frailty prior to aortic valve intervention is recommended in European and North American valvular heart disease guidelines. However, there is a lack of... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Assessment of frailty prior to aortic valve intervention is recommended in European and North American valvular heart disease guidelines. However, there is a lack of consensus on how it is best measured. The Clinical Frailty Scale (CFS) is a well-validated measure of frailty that is relatively quick to calculate. This meta-analysis sought to examine whether the CFS predicts mortality and morbidity following either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR).
METHODS
Nine electronic databases were searched systematically for data on clinical outcomes post-TAVI/SAVR, where patients had undergone preoperative frailty assessment using the CFS. The primary endpoint was 12-month mortality. TAVI and SAVR data were assessed and reported separately. For each individual study, the incidence of adverse outcomes was extracted according to a CFS score of 5-9 (ie, frail) versus 1-4 (ie, non-frail), with meta-analysis performed using a random effects model.
RESULTS
Of 2612 records screened, nine were included in the review (five TAVI, three SAVR and one which included both interventions). Among 4923 TAVI patients, meta-analysis showed 12-month mortality rates of 19.1% for the frail cohort versus 9.8% for the non-frail cohort (RR 2.53 (1.63 to 3.95), p<0.001, I=83%). For the smaller cohort of SAVR patients (n=454), mortality rates were 20.3% versus 3.9% for the frail and non-frail cohorts, respectively (RR 5.08 (2.31 to 11.15), p<0.001, I=5%).
CONCLUSIONS
Frailty, as determined by the CFS, was associated with an increased mortality risk in the 12 months following either TAVI or SAVR. These data would support its use in the preoperative assessment of elderly patients undergoing aortic valve interventions.
Topics: Humans; Aged; Aortic Valve; Aortic Valve Stenosis; Frailty; Risk Factors; Transcatheter Aortic Valve Replacement
PubMed: 37567604
DOI: 10.1136/openhrt-2023-002354 -
Open Heart Jan 2024A quarter of patients with severe aortic stenosis (AS) were asymptomatic, and only a third of them survived at the end of 4 years. Only a select subset of these patients... (Meta-Analysis)
Meta-Analysis
Systematic review and meta-analysis of early aortic valve replacement versus conservative therapy in patients with asymptomatic aortic valve stenosis with preserved left ventricle systolic function.
BACKGROUND
A quarter of patients with severe aortic stenosis (AS) were asymptomatic, and only a third of them survived at the end of 4 years. Only a select subset of these patients was recommended for aortic valve replacement (AVR) by the current American College of Cardiology/American Heart Association guidelines. We intended to study the effect of early AVR (eAVR) in this subset of asymptomatic patients with preserved left ventricle function.
METHODS AND RESULTS
We searched PubMed and Embase for randomised and observational studies comparing the effect of eAVR versus conservative therapy in patients with severe, asymptomatic AS and normal left ventricular function. The primary outcome was all-cause mortality. The secondary outcomes were composite major adverse cardiac events (MACE) (study defined), myocardial infarction (MI), stroke, cardiac death, sudden death, the development of symptoms, heart failure hospitalisations and major bleeding. We used GRADEPro to assess the certainty of the evidence. In the randomised controlled trial (RCT) only analysis, we found no significant difference in all-cause mortality between the early aortic intervention group versus the conservative arm (CA) (incidence rate ratio, IRR (CI): 0.5 (0.2 to 1.1), I=31%, p=0.09). However, in the overall cohort, we found mortality benefit for eAVR over CA (IRR (CI): 0.4 (0.3 to 0.7), I=84%, p<0.01). There were significantly lower MACE, cardiac death, sudden death, development of symptoms and heart failure hospitalisations in the eAVR group. We noticed no difference in MI, stroke and major bleeding.
CONCLUSION
We conclude that there is no reduction in all-cause mortality in the eAVR arm in patients with asymptomatic AS with preserved ejection fraction. However, eAVR reduces heart failure related hospitalisations and death or heart failure hospitalisations.
PROSPERO REGISTRATION NUMBER
CRD42022306132.
Topics: Humans; Aortic Valve; Aortic Valve Stenosis; Conservative Treatment; Death, Sudden, Cardiac; Heart Failure; Hemorrhage; Myocardial Infarction; Stroke; United States; Ventricular Function, Left; Heart Valve Prosthesis Implantation; Transcatheter Aortic Valve Replacement
PubMed: 38191233
DOI: 10.1136/openhrt-2023-002511