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International Journal of Surgery... Aug 2023Whether there are differences among the new-generation transcatheter aortic valve implantation (TAVI) devices for patients with aortic stenosis remains unclear. The aim... (Meta-Analysis)
Meta-Analysis
Comparisons of different new-generation transcatheter aortic valve implantation devices for patients with severe aortic stenosis: a systematic review and network meta-analysis.
BACKGROUND
Whether there are differences among the new-generation transcatheter aortic valve implantation (TAVI) devices for patients with aortic stenosis remains unclear. The aim of the study was to compare the efficiency and safety of different new-generation TAVI devices for patients with aortic stenosis.
MATERIALS AND METHODS
A comprehensive search of PubMed, Embase and Web of Science from their inception to 1 February 2022. Randomized clinical trials and observational studies that compared two or more different TAVI devices were enroled. Pairwise meta-analysis and frequentist network meta-analysis were conducted to pool the outcome estimates of interest.
RESULTS
A total of 79 studies were finally included. According to the surface under the cumulative ranking, the top two ranked valves for lower rates of events were as follows: direct flow medical (DFM) (4.6%) and Lotus (48.8%) for lower rate of device success; Sapien 3 (16.8%) and DFM (19.7%) for lower mortality; DFM (8.6%) and Sapien 3 (25.5%) for lower rates of stroke; Evolut (27.6%) and DFM (35.8%) for lower rates of major and life-threatening bleeding; Portico (22.6%) and Sapien 3 (41.9%) for lower rates of acute kidney injury; Acurate (8.6%) and DFM (13.2%) for lower rates of permanent pacemaker implantation; Lotus (0.3%) and Sapien 3 (22.7%) for lower rates of paravalvular leak; Evolut (1.4%) and Portico (29.1%) for lower rates of mean aortic valve gradients.
CONCLUSIONS
The findings of the present study suggested that the device success rates were comparable among these new-generation valves except for DFM. After excluding DFM, Sapien 3 might be the best effective for decreased mortality and stroke; Lotus might be the best effective for decreased paravalvular leak; Evolut might be the best effective for decreased major and life-threatening bleeding and mean aortic valve gradients; Acurate and Portico might be the best effective for decreased permanent pacemaker implantation and acute kidney injury, respectively.
Topics: Humans; Transcatheter Aortic Valve Replacement; Aortic Valve; Network Meta-Analysis; Postoperative Complications; Treatment Outcome; Heart Valve Prosthesis; Prosthesis Design; Severity of Illness Index; Aortic Valve Stenosis; Stroke; Acute Kidney Injury
PubMed: 37161443
DOI: 10.1097/JS9.0000000000000456 -
JAMA Mar 2002Throughout the past 40 years, a vast and sometimes contradictory literature has accumulated regarding hypertrophic cardiomyopathy (HCM), a genetic cardiac disease caused... (Review)
Review
CONTEXT
Throughout the past 40 years, a vast and sometimes contradictory literature has accumulated regarding hypertrophic cardiomyopathy (HCM), a genetic cardiac disease caused by a variety of mutations in genes encoding sarcomeric proteins and characterized by a broad and expanding clinical spectrum.
OBJECTIVES
To clarify and summarize the relevant clinical issues and to profile rapidly evolving concepts regarding HCM.
DATA SOURCES
Systematic analysis of the relevant HCM literature, accessed through MEDLINE (1966-2000), bibliographies, and interactions with investigators.
STUDY SELECTION AND DATA EXTRACTION
Diverse information was assimilated into a rigorous and objective contemporary description of HCM, affording greatest weight to prospective, controlled, and evidence-based studies.
DATA SYNTHESIS
Hypertrophic cardiomyopathy is a relatively common genetic cardiac disease (1:500 in the general population) that is heterogeneous with respect to disease-causing mutations, presentation, prognosis, and treatment strategies. Visibility attached to HCM relates largely to its recognition as the most common cause of sudden death in the young (including competitive athletes). Clinical diagnosis is by 2-dimensional echocardiographic identification of otherwise unexplained left ventricular wall thickening in the presence of a nondilated cavity. Overall, HCM confers an annual mortality rate of about 1% and in most patients is compatible with little or no disability and normal life expectancy. Subsets with higher mortality or morbidity are linked to the complications of sudden death, progressive heart failure, and atrial fibrillation with embolic stroke. Treatment strategies depend on appropriate patient selection, including drug treatment for exertional dyspnea (beta-blockers, verapamil, disopyramide) and the septal myotomy-myectomy operation, which is the standard of care for severe refractory symptoms associated with marked outflow obstruction; alcohol septal ablation and pacing are alternatives to surgery for selected patients. High-risk patients may be treated effectively for sudden death prevention with the implantable cardioverter-defibrillator.
CONCLUSIONS
Substantial understanding has evolved regarding the epidemiology and clinical course of HCM, as well as novel treatment strategies that may alter its natural history. An appreciation that HCM, although an important cause of death and disability at all ages, does not invariably convey ominous prognosis and is compatible with normal longevity should dictate a large measure of reassurance for many patients.
Topics: Cardiomyopathy, Hypertrophic; Humans; Phenotype; Prognosis; Risk Assessment
PubMed: 11886323
DOI: 10.1001/jama.287.10.1308 -
Brazilian Journal of Cardiovascular... May 2023Congenital heart diseases (CHDs) constitute the most prevalent congenital pathology, and they are a consequence of structural and functional abnormalities during fetal... (Review)
Review
INTRODUCTION
Congenital heart diseases (CHDs) constitute the most prevalent congenital pathology, and they are a consequence of structural and functional abnormalities during fetal development. The etiology of CHD involves the interaction of genetic and environmental factors. Fetal cardiac surgery aims at preventing natural pathways of CHD in utero, mitigating progression to more complex abnormalities. The goal of this review was to demonstrate the benefits and risks of fetal interventions in the two most prevalent CHDs, pulmonary stenosis and pulmonary atresia with an intact ventricular septum, but also critical aortic stenosis and hypoplastic left heart syndrome.
METHODS
Original and relevant articles were selected by meta-aggregation to perform a qualitative analysis of fetal cardiac interventions for pulmonary stenosis and critical aortic stenosis. The Joanna Briggs Institute's Qualitative Assessment and Review Instrument (or JBI-QARI) was used for data quality appraisal.
RESULTS
Of 61 potential articles, 13 were selected, and nine were finally included. Discussion: The present review demonstrated that fetal cardiac surgery increases right ventricular growth and hemodynamic flow in pulmonary stenosis, whereas in critical aortic stenosis it enables growth of the left ventricle and increases left ventricular pressure. However, it has a high complication rate, along with considerable morbidity and mortality.
CONCLUSION
The benefits of fetal cardiac surgery for pulmonary stenosis and critical aortic stenosis are well-described in the literature; however, there is a significant risk of complications which can be reduced by the surgeon's technical expertise and well-structured hospital facilities.
Topics: Humans; Heart Defects, Congenital; Pulmonary Atresia; Aortic Valve Stenosis; Pulmonary Valve Stenosis; Risk Assessment
PubMed: 36592074
DOI: 10.21470/1678-9741-2022-0273 -
PloS One 2018Symptomatic aortic stenosis has a poor prognosis. Many patients are considered inoperable or at high surgical risk for surgical aortic valve replacement (SAVR),... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Symptomatic aortic stenosis has a poor prognosis. Many patients are considered inoperable or at high surgical risk for surgical aortic valve replacement (SAVR), reflecting their age, comorbidities and frailty. The clinical effectiveness and safety of TAVI have not been reviewed systematically for these high levels of surgical risk. This systematic review compares mortality and other important clinical outcomes up to 5 years post treatment following TAVI or other treatment in these risk groups.
METHODS
A systematic review protocol was registered on the PROSPERO database (CRD42016048396). The Cochrane Library, Centre for Reviews and Dissemination Databases, MEDLINE, EMBASE, and ZETOC were searched from January 2002 to August 2016. Clinical trials or matched studies comparing TAVI with other treatments for AS in patients surgically inoperable or operable at a high risk were included. Data extraction and quality assessment were conducted by two reviewers. Data were pooled using random-effects meta-analysis. The main outcomes were all-cause mortality, efficacy and major complications.
RESULTS
Three good quality randomised controlled trials (RCTs) were included. Patients' mean age ranged from 83-85 years, around half were female and New York Heart Association (NYHA) functional class III or IV ranged from 83.8% to 94.2% with frequent comorbidities. In 358 surgically inoperable patients from one RCT, TAVI was superior to medical therapy for all-cause mortality at 1 year (hazard ratio (HR) 0.58, 95% confidence interval (CI) 0.36-0.92), 2 years (HR 0.50, 95% CI 0.39-0.65), 3 years (HR 0.53, 95% CI 0.41to 0.68) and 5 years (HR 0.50, 95% CI 0.39-0.65), and NYHA class III or IV at 2 years (TAVI 16.8% (16/95), medical therapy 57.5% (23/40), p<0.001), quality of life and re-hospitalisation. TAVI had higher risks of major bleeding up to 1 year, of stroke up to 3 years (at one year 11.2% versus 5.5%, p = .06; HR at 2 years 2.79, 95% CI 1.25-6.22; HR at 3 years 2.81; 95% CI 1.26-6.26) and of major vascular complication at 3 years (HR 8.27, 95% CI 2.92-23.44). Using the GRADE tool, this evidence was considered to be of moderate quality. In a meta-analysis including 1,494 high risk surgically operable patients from two non-inferiority RCTs TAVI showed no significant differences from SAVR in all-cause mortality at two years (HR 1.03, 95% CI 0.82-1.29) and up to 5 years (HR 0.83, 95% CI 0.83-1.12). There were no statistically significant differences in major vascular complications and myocardial infarction at any time point, discrepant results for major bleeding on variable definitions and no differences in stroke rate at any time point. Using the GRADE tool, this evidence was considered of low quality.
CONCLUSIONS
Symptomatic aortic stenosis can be lethal without intervention but surgical resection is contraindicated for some patients and high risk for others. We found that all-cause mortality up to 5 years of follow-up did not differ significantly between TAVI and SAVR in patients surgically operable at a high risk, but favoured TAVI over medical therapy in patients surgically inoperable. TAVI is a viable life-extending treatment option in these surgical high risk groups.
Topics: Aged, 80 and over; Aortic Valve Stenosis; Female; Humans; MEDLINE; Male; Risk Factors; Transcatheter Aortic Valve Replacement
PubMed: 29746546
DOI: 10.1371/journal.pone.0196877 -
Hellenic Journal of Cardiology : HJC =... 2021The research findings concerning the effect of early surgery on mortality among asymptomatic patients with severe aortic valve stenosis (AS) are controversial and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The research findings concerning the effect of early surgery on mortality among asymptomatic patients with severe aortic valve stenosis (AS) are controversial and contradictory. In this study, the total weight of evidence regarding early surgery versus conservative management in these population was examined.
METHODS
Embase, PubMed, CENTRAL, and CINAHL databases were thoroughly searched without language restriction until 29 February, 2020. We included all studies exploring the mortality in asymptomatic patients with severe AS comparing early surgery with conservative management and obtained data in a standard form. Pooled relative risks ratios (RRs) and 95% confidence intervals (CI) were pooled by using a random- or fixed-effects model and by using intention-to-treat principle. Randomized controlled trials (RCTs) and observational studies (OSs) were analyzed separately.
RESULTS
Finally, 8 studies involving 2462 patients were enrolled, including 1 RCT and 7 OSs. In the OSs, early surgery was linked with significant reduction among all-cause mortality (RR & 95% CI, I: 0.32 (0.18-0.57), 84.9%) and cardiac death (0.28 (0.18-0.45), 62.5%) in asymptomatic patients with severe AS. The superiority of early surgery over conservative management in reducing all-cause mortality in these patients is also intensified in the RCT.
CONCLUSIONS
The existing RCT and OSs indicate that earlier surgery is associated with better outcomes for asymptomatic patients with severe AS. Nevertheless, more well-designed and large-sized RCTs are needed to find an individual approach focusing on individual risk stratification and staging.
Topics: Aortic Valve; Aortic Valve Stenosis; Conservative Treatment; Humans
PubMed: 33549719
DOI: 10.1016/j.hjc.2021.01.005 -
BMC Cardiovascular Disorders May 2022With advancements in cancer treatment, the life expectancy of oncology patients has improved. Thus, transcatheter aortic valve replacement (TAVR) may be considered as a... (Meta-Analysis)
Meta-Analysis
BACKGROUND
With advancements in cancer treatment, the life expectancy of oncology patients has improved. Thus, transcatheter aortic valve replacement (TAVR) may be considered as a feasible option for oncology patients with severe symptomatic aortic stenosis (AS). We aim to evaluate the difference in short- and long-term all-cause mortality in cancer and non-cancer patients treated with TAVR for severe AS.
METHODS
Medline, PubMed, and Cochrane Central Register of Controlled Trials were searched for relevant studies. Patients with cancer who underwent treatment with TAVR for severe AS were included and compared to an identical population without cancer. The primary endpoints were short- and long-term all-cause mortality.
RESULTS
Of 899 studies included, 8 met inclusion criteria. Cancer patients had significantly higher long-term all-cause mortality after TAVR when compared to patients without cancer (risk ratio [RR] 1.43; 95% confidence interval (CI) 1.26-1.62; P < 0.01). Four studies evaluated short-term mortality after TAVR and demonstrated no difference in it in patients with and without cancer (RR 0.72; 95% CI 0.47-1.08; P = 0.11).
CONCLUSION
Patients with cancer and severe AS have higher long-term all-cause mortality after TAVR. However, we found no difference in short-term all-cause mortality when comparing patients with and without cancer. The decision to perform TAVR in cancer patients should be individualized based on life expectancy and existing co-morbidities.
Topics: Aortic Valve; Aortic Valve Stenosis; Heart Valve Prosthesis Implantation; Humans; Neoplasms; Risk Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 35538411
DOI: 10.1186/s12872-022-02651-4 -
Cardiovascular Research Jul 2023Although evidence indicates the association of lipoprotein(a) [Lp(a)] with atherosclerosis, the link with calcific aortic valve disease (CAVD) is unclear. This... (Meta-Analysis)
Meta-Analysis
Although evidence indicates the association of lipoprotein(a) [Lp(a)] with atherosclerosis, the link with calcific aortic valve disease (CAVD) is unclear. This systematic review and meta-analysis explores the connection between Lp(a) and aortic valve calcification and stenosis (AVS). We included all relevant studies, indexed in eight databases, up to February 2023. A total of 44 studies (163 139 subjects) were included, with 16 of them being further meta-analysed. Despite considerable heterogeneity, most studies support the relationship between Lp(a) and CAVD, especially in younger populations, with evidence of early aortic valve micro-calcification in elevated-Lp(a) populations. The quantitative synthesis showed higher Lp(a) levels, by 22.63 nmol/L (95% CI: 9.98-35.27), for patients with AVS, while meta-regressing the data revealed smaller Lp(a) differences for older populations with a higher proportion of females. The meta-analysis of eight studies providing genetic data, revealed that the minor alleles of both rs10455872 and rs3798220 LPA gene loci were associated with higher risk for AVS (pooled odds ratio 1.42; 95% CI: 1.34-1.50 and 1.27; 95% CI: 1.09-1.48, respectively). Importantly, high-Lp(a) individuals displayed not only faster AVS progression, by a mean difference of 0.09 m/s/year (95% CI: 0.09-0.09), but also a higher risk of serious adverse outcomes, including death (pooled hazard ratio 1.39; 95% CI: 1.01-1.90). These summary findings highlight the effect of Lp(a) on CAVD initiation, progression and outcomes, and support the early onset of Lp(a)-related subclinical lesions before clinical evidence.
Topics: Female; Humans; Aortic Valve; Aortic Valve Stenosis; Hyperlipidemias; Lipoprotein(a); Risk Factors
PubMed: 37078819
DOI: 10.1093/cvr/cvad062 -
Heart, Lung & Circulation Jul 2015Transcatheter aortic valve implantation (TAVI) is a feasible interventional technique for severe aortic stenosis in patients who are deemed inoperable or at high... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Transcatheter aortic valve implantation (TAVI) is a feasible interventional technique for severe aortic stenosis in patients who are deemed inoperable or at high surgical risk. There is limited evidence for the safety and efficacy of TAVI in patients with bicuspid aortic valves (BAV), the most common congenital valve abnormality. In many TAVI trials, patients with BAV have been contraindicated due to concerns surrounding abnormal valve geometry, leading to malfunction or malpositioning. A systematic review and meta-analysis was conducted in order to assess the current evidence and relative merits of TAVI in aortic stenosis patients with BAV.
METHOD
From six electronic databases, seven articles including 149 BAV and 2096 non-BAV patients undergoing TAVI were analysed.
RESULTS
Between the BAV and no-BAV cohorts, there was no difference in 30-day mortality (8.3% vs 9.0%; P=0.68), post-TAVI mean peak gradients (weighted mean difference, 0.36 mmHg; P=0.55), moderate or severe paravalvular leak (25.7% vs 19.9%; P=0.29), pacemaker implantations (18.5% vs 27.9%; P=0.52), life-threatening bleeding (8.2% vs 13.9%; P=0.33), major bleeding (20% vs 16.8%; P=0.88), conversion to conventional surgery (1.9% vs 1.2%; P=0.18) and vascular complications (8.6% vs 10.1%; P=0.32).
CONCLUSIONS
Preliminary short and mid-term pooled data from observation studies suggest that TAVI is feasible and safe in older patients with BAV. While future randomised trials are not likely, larger adequately-powered multi-institutional studies are warranted to assess the long-term durability and complications associated with TAVI in older BAV patients with severe aortic stenosis.
Topics: Aortic Valve; Aortic Valve Stenosis; Bicuspid Aortic Valve Disease; Female; Heart Valve Diseases; Humans; Male; Transcatheter Aortic Valve Replacement
PubMed: 25818374
DOI: 10.1016/j.hlc.2014.12.163 -
Journal of the American Heart... Aug 2016Optimal initial treatment for congenital aortic valve stenosis in children remains unclear between balloon aortic valvuloplasty (BAV) and surgical aortic valvotomy (SAV). (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
Optimal initial treatment for congenital aortic valve stenosis in children remains unclear between balloon aortic valvuloplasty (BAV) and surgical aortic valvotomy (SAV).
METHODS AND RESULTS
We performed a contemporary systematic review and meta-analysis to compare survival in children with congenital aortic valve stenosis. Secondary outcomes included frequency of at least moderate regurgitation at hospital discharge as well as rates of aortic valve replacement and reintervention. Single- and dual-arm studies were identified by a search of PubMed (Medline), Embase, and the Cochrane database. Overall 2368 patients from 20 studies were included in the analysis, including 1835 (77%) in the BAV group and 533 (23%) in the SAV group. There was no difference between SAV and BAV in hospital mortality (OR=0.98, 95% CI 0.5-2.0, P=0.27, I(2)=22%) or frequency of at least moderate aortic regurgitation at discharge (OR=0.58, 95% CI 0.3-1.3, P=0.09, I(2)=54%). Kaplan-Meier analysis showed no difference in long-term survival or freedom from aortic valve replacement but significantly more reintervention in the BAV group (10-year freedom from reintervention of 46% [95% CI 40-52] for BAV versus 73% [95% CI 68-77] for SAV, P<0.001). Results were unchanged in a sensitivity analysis restricted to infants (<1 year of age).
CONCLUSIONS
Although higher rates of reintervention suggest improved outcomes with SAV, indications for reintervention may vary depending on initial intervention. When considering the benefits of a less-invasive approach, and clinical equipoise with respect to more clinically relevant outcomes, these findings support the need for a randomized controlled trial.
Topics: Aortic Valve; Aortic Valve Stenosis; Balloon Valvuloplasty; Humans
PubMed: 27503847
DOI: 10.1161/JAHA.116.003931 -
JACC. Cardiovascular Imaging Mar 2023Aortic valve stenosis is a progressive disorder with variable progression rates. The factors affecting aortic stenosis (AS) progression remain largely unknown. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Aortic valve stenosis is a progressive disorder with variable progression rates. The factors affecting aortic stenosis (AS) progression remain largely unknown.
OBJECTIVES
This systematic review and meta-analysis sought to determine AS progression rates and to assess the impact of baseline AS severity and sex on disease progression.
METHODS
The authors searched Medline, Embase, and the Cochrane Central Register of Controlled Trials from inception to July 1, 2020, for prospective studies evaluating the progression of AS with the use of echocardiography (mean gradient [MG], peak velocity [PV], peak gradient [PG], or aortic valve area [AVA]) or computed tomography (calcium score [AVC]). Random-effects meta-analysis was performed to evaluate the rate of AS progression for each parameter stratified by baseline severity, and meta-regression was performed to determine the impact of baseline severity and of sex on AS progression rate.
RESULTS
A total of 24 studies including 5,450 patients (40% female) met inclusion criteria. The pooled annualized progression of MG was +4.10 mm Hg (95% CI: 2.80-5.41 mm Hg), AVA -0.08 cm (95% CI: 0.06-0.10 cm), PV +0.19 m/s (95% CI: 0.13-0.24 m/s), PG +7.86 mm Hg (95% CI: 4.98-10.75 mm Hg), and AVC +158.5 AU (95% CI: 55.0-261.9 AU). Increasing baseline severity of AS was predictive of higher rates of progression for MG (P < 0.001), PV (P = 0.001), and AVC (P < 0.001), but not AVA (P = 0.34) or PG (P = 0.21). Only 4 studies reported AS progression stratified by sex, with only PV and AVC having 3 studies to perform a meta-analysis. No difference between sex was observed for PV (P = 0.397) or AVC (P = 0.572), but the level of confidence was low.
CONCLUSIONS
This study provides progression rates for both hemodynamic and anatomic parameters of AS and shows that increasing hemodynamic and anatomic baseline severity is associated with faster AS progression. More studies are needed to determine if sex differences affect AS progression. (Aortic Valve Stenosis Progression Rate: A Systematic Review and Meta-Analysis; CRD42021207726).
Topics: Humans; Female; Male; Aortic Valve; Prospective Studies; Predictive Value of Tests; Aortic Valve Stenosis; Hemodynamics; Severity of Illness Index
PubMed: 36648053
DOI: 10.1016/j.jcmg.2022.10.009