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European Heart Journal May 2017To review maternal and foetal outcomes in women with mechanical heart valves (MHVs) treated with vitamin-K antagonists (VKAs), first-trimester heparin followed by VKAs... (Meta-Analysis)
Meta-Analysis Review
AIMS
To review maternal and foetal outcomes in women with mechanical heart valves (MHVs) treated with vitamin-K antagonists (VKAs), first-trimester heparin followed by VKAs (sequential treatment), low molecular weight heparin (LMWH) and unfractionated heparin (UFH) during pregnancy, in order to inform practice.
METHODS AND RESULTS
Medline, Embase and Central were searched from inception until February 2016. Two reviewers independently screened 1786 titles, reviewed 110 full-texts and extracted data and assessed risk-of-bias from 46 articles. Pooled incidence (95% confidence intervals) was calculated for maternal and foetal outcomes. Included studies had a moderate or high risk-of-bias. With VKAs, sequential treatment and LMWH, maternal mortality occurred in 0.9% (0.4-1.4), 2.0% (0.8-3.1) and 2.9% (0.2-5.7), thromboembolic complications in 2.7% (1.4-4.0), 5.8% (3.8-7.7) and 8.7% (3.9-13.4), livebirths in 64.5% (48.8-80.2), 79.9% (74.3-85.6) and 92.0% (86.1-98.0) and anticoagulant-related foetal/neonatal adverse events (embryopathy or foetopathy) in 2.0% (0.3-3.7), 1.4% (0.3-2.5) and 0%, respectively. When UFH is used throughout pregnancy, 11.2% (2.8-19.6) suffered thromboembolic complications. Foetal loss and adverse events occurred with first-trimester warfarin doses ≤ 5 mg/day, although there were more livebirths [83.6% (75.8-91.4) vs. 43.9% (32.8-55.0)] and fewer foetal anomalies [2.3% (0.7-4.0) vs. 12.4% (3.3-21.6)] with lower doses than with warfarin > 5 mg/day.
CONCLUSIONS
VKAs are associated with fewest maternal complications but also with fewest livebirths. Sequential treatment does not eliminate anticoagulant-related foetal/neonatal adverse events. LMWH is associated with the highest number of livebirths. The safety of UFH throughout pregnancy and first-trimester warfarin ≤ 5 mg/day remains unconfirmed.
Topics: Anticoagulants; Female; Fetal Death; Fetal Diseases; Heart Valve Prosthesis; Heparin; Heparin, Low-Molecular-Weight; Humans; Incidence; Maternal Mortality; Pregnancy; Pregnancy Complications, Cardiovascular; Pregnancy Outcome; Pregnancy Trimester, First; Thromboembolism; Vitamin K; Warfarin
PubMed: 28329059
DOI: 10.1093/eurheartj/ehx032 -
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 -
Heart Views : the Official Journal of... 2022Transcatheter aortic valve in valve (Aviv) replacement has been shown to be an effective therapeutic option in patients with failed aortic bioprosthetic valves. This... (Review)
Review
BACKGROUND
Transcatheter aortic valve in valve (Aviv) replacement has been shown to be an effective therapeutic option in patients with failed aortic bioprosthetic valves. This review intended to evaluate contemporary 1-year outcomes of Aviv in recent studies.
METHODS
A systematic review on outcomes of Aviv was performed using the best available evidence from studies obtained using a MEDLINE, Cochrane database, and SCOPUS search. Endpoints of interest were survival, coronary artery obstruction, prosthesis-patient mismatch (PPM), stroke, pacemaker implantation, and structural valve deterioration.
RESULTS
A total of 3339 patients from 23 studies were included. Mean age was 68-80 years, 20%-50% were female, and Society of Thoracic Surgeons score ranged from 5.7 to 31.1. Thirty-day all-cause mortality ranged from 2% to 8%, and 1-year all-cause mortality ranged from 8% to 33%. Coronary artery obstruction risk after Aviv ranged from 0.6% to 4%. One-year stroke ranged from 2% to 8%. Moderate-severe PPM occurred in 11%-58%, and pacemaker rate at 1 year ranged from 5% to 12%.
CONCLUSION
Transcatheter aortic ViV has emerged as an effective therapeutic option to treat patients with failed bioprostheses. The acceptable complication rate and favorable 1-year outcomes make Aviv an appropriate alternative to redo surgical aortic valve replacement.
PubMed: 35757448
DOI: 10.4103/heartviews.heartviews_25_22 -
JAMA Network Open Jan 2023Recent European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines highlighted some concerns about the randomized clinical... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Recent European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines highlighted some concerns about the randomized clinical trials (RCTs) comparing transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) for aortic stenosis. Quantification of these biases has not been previously performed.
OBJECTIVE
To assess whether randomization protects RCTs comparing TAVI and SAVR from biases other than nonrandom allocation.
DATA SOURCES
A systematic review of the literature between January 1, 2007, and June 6, 2022, on MEDLINE, Embase, and Cochrane Central Register of Controlled Trials was performed. Specialist websites were also checked for unpublished data.
STUDY SELECTION
The study included RCTs with random allocation to TAVI or SAVR with a maximum 5-year follow-up.
DATA EXTRACTION AND SYNTHESIS
Data extraction was performed by 2 independent investigators following the PRISMA guidelines. A random-effects meta-analysis was used for quantifying pooled rates and differential rates between treatments of deviation from random assigned treatment (DAT), loss to follow-up, and receipt of additional treatments.
MAIN OUTCOMES AND MEASURES
The primary outcomes were the proportion of DAT, loss to follow-up, and patients who were provided additional treatments and myocardial revascularization, together with their ratio between treatments. The measures were the pooled overall proportion of the primary outcomes and the risk ratio (RR) in the TAVI vs SAVR groups.
RESULTS
The search identified 8 eligible trials including 8849 participants randomly assigned to undergo TAVI (n = 4458) or SAVR (n = 4391). The pooled proportion of DAT among the sample was 4.2% (95% CI, 3.0%-5.6%), favoring TAVI (pooled RR vs SAVR, 0.16; 95% CI, 0.08-0.36; P < .001). The pooled proportion of loss to follow-up was 4.8% (95% CI, 2.7%-7.3%). Meta-regression showed a significant association between the proportion of participants lost to follow-up and follow-up time (slope, 0.042; 95% CI, 0.017-0.066; P < .001). There was an imbalance of loss to follow-up favoring TAVI (RR, 0.39; 95% CI, 0.28-0.55; P < .001). The pooled proportion of patients who had additional procedures was 10.4% (95% CI, 4.4%-18.5%): 4.6% (95% CI, 1.5%-9.3%) in the TAVI group and 16.5% (95% CI, 7.5%-28.1%) in the SAVR group (RR, 0.27; 95% CI, 0.15-0.50; P < .001). The imbalance between groups also favored TAVI for additional myocardial revascularization (RR, 0.40; 95% CI, 0.24-0.68; P < .001).
CONCLUSIONS AND RELEVANCE
This study suggests that, in RCTs comparing TAVI vs SAVR, there are substantial proportions of DAT, loss to follow-up, and additional procedures together with systematic selective imbalance in the same direction characterized by significantly lower proportions of patients undergoing TAVI that might affect internal validity.
Topics: Humans; Aortic Valve; Heart Valve Prosthesis Implantation; Risk Factors; Randomized Controlled Trials as Topic; Bias
PubMed: 36595294
DOI: 10.1001/jamanetworkopen.2022.49321 -
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 -
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 -
Journal of Cardiac Surgery Nov 2022Postoperative acute kidney injury (AKI) and the requirement for renal replacement therapy (RRT) remain common and significant complications of both transcatheter... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Postoperative acute kidney injury (AKI) and the requirement for renal replacement therapy (RRT) remain common and significant complications of both transcatheter valve-in-valve aortic valve replacement (ViV-TAVR) and redo surgical aortic valve replacement (SAVR). Nevertheless, the understanding of renal outcomes in the population undergoing either redo SAVR or ViV-TAVR remains controversial.
METHODS
A systematic database search with meta-analysis was conducted of comparative original articles of ViV-TAVR versus redo SAVR in EMBASE, MEDLINE, Cochrane database, and Google Scholar, from inception to September 2021. Primary outcomes were AKI and RRT. Secondary outcomes were stroke, major bleeding, pacemaker implantation rate, operative mortality, and 30-day mortality.
RESULTS
Our search yielded 5435 relevant studies. Eighteen studies met the inclusion criteria with a total of 11,198 patients. We found ViV-TAVR to be associated with lower rates of AKI, postoperative RRT, major bleeding, pacemaker implantation, operative mortality, and 30-day mortality. No significant difference was observed in terms of stroke rate. The mean incidence of AKI in ViV-TAVR was 6.95% (±6%) and in redo SAVR was 15.2% (±9.6%). For RRT, our data showed that VIV-TAVR to be 1.48% (±1.46%) and redo SAVR to be 8.54% (±8.06%).
CONCLUSION
Renoprotective strategies should be put into place to prevent and reduce AKI incidence regardless of the treatment modality. Patients undergoing re-intervention for the aortic valve constitute a high-risk and frail population in which ViV-TAVR demonstrated it might be a feasible option for carefully selected patients. Long-term follow-up data and randomized control trials will be needed to evaluate mortality and morbidity outcomes between these 2 treatments.
Topics: Acute Kidney Injury; Aortic Valve; Aortic Valve Stenosis; Heart Valve Prosthesis Implantation; Humans; Reoperation; Risk Factors; Stroke; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 36040611
DOI: 10.1111/jocs.16890 -
Scandinavian Journal of Surgery : SJS :... Dec 2022The published literature investigating the impact of sex on outcomes after mitral valve (MV) surgery has demonstrated inferior outcomes for females over males. However,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND OBJECTIVE
The published literature investigating the impact of sex on outcomes after mitral valve (MV) surgery has demonstrated inferior outcomes for females over males. However, the true relationship between sex and outcomes after MV surgery continues to be poorly understood.
MATERIALS
PubMed, Medline, and Embase were systematically searched for articles published from 1 January 2005 to 1 August 2021. This systematic review included retrospective and prospective studies investigating the relationship between sex and outcomes after MV surgery. In all, 2068 articles were initially screened and 12 studies were included in this review.
RESULTS
Few studies were adequately powered or structured to investigate this topic. Few studies propensity matched patients or isolated for surgical approach. In individual studies, females experienced increased rates of short-term and long-term mortality and increased 1-year mortality in the pooled data. Males experienced increased rates of required pacemaker insertion. The remaining rates of morbidity and mortality did not differ significantly between males and females.
CONCLUSIONS
This review identified increased rates of 1-year mortality in the pooled data for females, while males had increased rates of pacemaker insertion. Despite this, the absence of propensity matching and isolating for surgical approach has introduced confounding variables that impair the ability of the included studies to interpret the results found in the current literature. Studies isolating for surgical approach, propensity matching patients, and examining outcomes with long-term follow-up are required to elucidate the true nature of this relationship.
Topics: Male; Female; Humans; Mitral Valve; Heart Valve Prosthesis Implantation; Retrospective Studies; Prospective Studies; Cardiac Surgical Procedures; Treatment Outcome
PubMed: 36112913
DOI: 10.1177/14574969221124468 -
EuroIntervention : Journal of EuroPCR... Jan 2016To review the outcomes of studies and the safety of newer transcatheter aortic valves (THV). (Meta-Analysis)
Meta-Analysis Review
AIMS
To review the outcomes of studies and the safety of newer transcatheter aortic valves (THV).
METHODS AND RESULTS
All studies reporting on second-generation THV were identified and pooled using the systematic review guidelines. Twenty-four reports on 1,708 patients and eight THV were included in the analysis. The pooled 30-day event rate for mortality after transcatheter aortic valve implantation (TAVI) was 5.7% (95% CI: 4.0-7.8), myocardial infarction (MI) was 1.7% (95% CI: 1.1-2.6), stage 3 acute kidney injury (AKI) was 3.4% (95% CI: 2.0-5.6), life-threatening bleeding was 5.1% (95% CI: 3.3-7.8), major vascular complications was 4.9% (95% CI: 3.5-6.6%), major bleeding was 10.5% (95% CI: 5.1-20.4), major stroke was 2.4% (95% CI: 1.7-3.4), permanent pacemaker utilisation was 13.5% (95% CI: 10.8-16.9), and coronary obstruction was 1.2% (95% CI: 0.6%-2.4%). Moderate or severe aortic insufficiency (AI) after TAVI was 4.2% (95% CI: 2.0-8.5). The pooled 30-day mean gradient and effective orifice area (EOA) were 11.63 mmHg (95% CI: 10.19-13.07) and 1.60 cm2 (95% CI: 1.5-1.7), respectively. All estimates compare favourably to events reported for first-generation valves.
CONCLUSIONS
Our findings suggest that the new THV have a low risk of TAVI-related short-term complications.
Topics: Aortic Valve; Cardiac Catheterization; Heart Valve Diseases; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Odds Ratio; Patient Safety; Prosthesis Design; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome
PubMed: 26788706
DOI: 10.4244/EIJV11I9A211