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Current Cardiology Reports Mar 2021This systematic review was performed to evaluate the results of transcatheter mitral valve implantation (TMVI) in the native mitral valve. (Review)
Review
INTRODUCTION
This systematic review was performed to evaluate the results of transcatheter mitral valve implantation (TMVI) in the native mitral valve.
EVIDENCE ACQUISITION
Medline, EMBASE, and the Cochrane Central register were systematically searched for studies that reported results of TMVI in mitral valve regurgitation and/or stenosis and mitral annular calcification. To improve the sensitivity of the literature search, we performed citation chasing in Google Scholar, Scopus, and Web of Science.
EVIDENCE SYNTHESIS
Twelve studies reporting results of TMVI in mitral regurgitation were retrieved and included 347 patients. The transseptal approach represented 28% of cases. Secondary mitral regurgitation was the predominant indication in 63% of cases. Thirty-day mortality was 11% and was lowered with the transseptal approach (7%). Technical success was 92%. Surgical conversion was needed in 5% of patients. Only one patient presented moderate to severe mitral regurgitation. These hemodynamic results were sustainable up to one year of follow-up. Three series focused on results of TMVI in mitral annulus calcification including 167 patients. Only nine patients were treated with TMVI dedicated prosthesis. Eighty-seven patients had their prosthesis delivered through a transseptal approach. Mitral stenosis was present in 63% of cases. Thirty-day mortality was 24%, and none with TMVI prosthesis. Technical success was achieved in 71% of cases and was improved by using TMVI prosthesis (89%). The main complication was left ventricular outflow tract obstruction (20%). Post procedural moderate to severe mitral regurgitation was observed in 4% of cases.
CONCLUSION
TMVI seems to be feasible, achieving good technical success and predictable and durable MR reduction.
Topics: Cardiac Catheterization; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Mitral Valve; Mitral Valve Insufficiency; Treatment Outcome
PubMed: 33687594
DOI: 10.1007/s11886-021-01466-7 -
European Heart Journal Oct 2019Owing to new evidence from randomized controlled trials (RCTs) in low-risk patients with severe aortic stenosis, we compared the collective safety and efficacy of... (Meta-Analysis)
Meta-Analysis
AIMS
Owing to new evidence from randomized controlled trials (RCTs) in low-risk patients with severe aortic stenosis, we compared the collective safety and efficacy of transcatheter aortic valve implantation (TAVI) vs. surgical aortic valve replacement (SAVR) across the entire spectrum of surgical risk patients.
METHODS AND RESULTS
The meta-analysis is registered with PROSPERO (CRD42016037273). We identified RCTs comparing TAVI with SAVR in patients with severe aortic stenosis reporting at different follow-up periods. We extracted trial, patient, intervention, and outcome characteristics following predefined criteria. The primary outcome was all-cause mortality up to 2 years for the main analysis. Seven trials that randomly assigned 8020 participants to TAVI (4014 patients) and SAVR (4006 patients) were included. The combined mean STS score in the TAVI arm was 9.4%, 5.1%, and 2.0% for high-, intermediate-, and low surgical risk trials, respectively. Transcatheter aortic valve implantation was associated with a significant reduction of all-cause mortality compared to SAVR {hazard ratio [HR] 0.88 [95% confidence interval (CI) 0.78-0.99], P = 0.030}; an effect that was consistent across the entire spectrum of surgical risk (P-for-interaction = 0.410) and irrespective of type of transcatheter heart valve (THV) system (P-for-interaction = 0.674). Transcatheter aortic valve implantation resulted in lower risk of strokes [HR 0.81 (95% CI 0.68-0.98), P = 0.028]. Surgical aortic valve replacement was associated with a lower risk of major vascular complications [HR 1.99 (95% CI 1.34-2.93), P = 0.001] and permanent pacemaker implantations [HR 2.27 (95% CI 1.47-3.64), P < 0.001] compared to TAVI.
CONCLUSION
Compared with SAVR, TAVI is associated with reduction in all-cause mortality and stroke up to 2 years irrespective of baseline surgical risk and type of THV system.
Topics: Aged; Aged, 80 and over; Aortic Valve; Aortic Valve Stenosis; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Male; Postoperative Complications; Transcatheter Aortic Valve Replacement
PubMed: 31329852
DOI: 10.1093/eurheartj/ehz275 -
Journal of the American Heart... Jun 2022Background There is a concern that resheathing/repositioning of transcatheter heart valves during transcatheter aortic valve implantation (TAVI) may lead to an increased... (Meta-Analysis)
Meta-Analysis Review
Background There is a concern that resheathing/repositioning of transcatheter heart valves during transcatheter aortic valve implantation (TAVI) may lead to an increased risk of periprocedural complications. We aimed to evaluate the short- and long-term impact on clinical outcomes of resheathing for repositioning of transcatheter heart valves during TAVI procedures. Methods and Results We conducted a systematic search of Embase, MEDLINE, and Cochrane Central Register of Controlled Trials databases to identify studies comparing outcomes between patients requiring resheathing/repositioning during TAVI and those who did not. Random-effects meta-analyses were used to estimate the association of resheathing compared with no resheathing with clinical outcomes after TAVI. Seven studies including 4501 participants (pooled mean age, 80.9±7.4 years; 54% women; and 1374 [30.5%] patients requiring resheathing/repositioning) were included in this study. No significant differences between the 2 groups were identified with regards to safety: 30-day mortality (n=3125; odds ratio [OR], 0.74 [95% confidence interval [CI], 0.41-1.33]; =0%), stroke (n=4121; OR, 1.09 [95% CI, 0.74-1.62]; =0%), coronary obstruction (n=3000; OR, 2.35 [95% CI, 0.17-33.47]; =75%), major vascular complications (n=3125; OR, 0.92 [95% CI, 0.66-1.33]; =0%), major bleeding (n=3125; OR, 1.13 [95% CI, 0.94-2.01]; =39%), acute kidney injury (n=3495; OR, 1.30 [95% CI, 0.64-2.62]; =44%), and efficacy outcomes: device success (n=1196; OR, 0.77 [95% CI, 0.51-1.14]; =0%), need for a second valve (n=3170; OR, 2.86 [95% CI, 0.96-8.48]; =62%), significant (moderate or higher) paravalvular leak (n=1151; OR, 1.53 [95% CI, 0.83-2.80]; =0%), and permanent pacemaker implantation (n=1908; OR, 1.04 [95% CI, 0.68-1.57]; =58%). One-year mortality was similar between groups (n=1972; OR, 1.00 [95% CI, 0.68-1.47]; =0%). Conclusions Resheathing of transcatheter heart valves during TAVI is associated with similar periprocedural risk compared with no resheathing in several patient-important outcomes. These data support the safety of current self-expanding transcatheter heart valves with resheathing features. Registration URL: https://www.crd.york.ac.uk/prospero/; Unique identifier: CRD42021273715.
Topics: Aged; Aged, 80 and over; Aortic Valve; Aortic Valve Stenosis; Female; Heart Valve Prosthesis; Humans; Male; Postoperative Complications; Risk Factors; Stroke; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 35699176
DOI: 10.1161/JAHA.121.024707 -
The Heart Surgery Forum Mar 2021Tricuspid valve replacement (TVR) is seldom performed in cardiac valve surgery, and there currently are no clinical guidelines as to which type of prostheses is better... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Tricuspid valve replacement (TVR) is seldom performed in cardiac valve surgery, and there currently are no clinical guidelines as to which type of prostheses is better in tricuspid valve position. This meta-analysis was performed to compare the results of mechanical and biological prostheses for TVR.
METHODS
We searched the Pubmed, Cochrane, and Embase clinical trial databases to collect all related studies published from January 1, 2000 to July 31, 2020. A random-effects model was used to evaluate the odds ratios (OR) and its 95% confidence intervals (CI) of time-to-event related effects of the surgical procedures; every study's quality was evaluated by the Newcastle-Ottawa Scale (NOS).
RESULTS
A total of 13 retrospective studies, including 1453 patients were analyzed. There were no statistically differences between mechanical and biological prostheses with respect to prosthetic valve failure [OR = 0.84, 95% CI(0.54, 1.28), P = .41], bleeding [OR = 0.84, 95% CI(0.54,1.28), P = .41], reoperation [OR = 1.02, 95% CI(0.58,1.78), P = .95], early mortality [OR = 1.35, 95% CI(0.82,2.25), P = .24] and long-time survival [OR = 1.09, 95% CI(0.70, 1.69), P = .70], but a significant difference can be seen in mechanical prostheses with a higher risk of thrombosis [OR = 0.17, 95% CI(0.05, 0.60), P = .006, I2 = 0%].
CONCLUSIONS
In tricuspid valve position, mechanical valve prostheses have a higher risk of thrombosis than biological prostheses, but no statistical differences between mechanical and biological prostheses with respect to prosthetic valve failure, bleeding, reoperation, early mortality, and long-term survival. The valve disease and patient's age and risk factors are the most important considerations in the decision-making process. The more specific conclusion needs to be further proved by large-sample, multi-center, randomized, double-blind and control trials.
Topics: Bioprosthesis; Heart Valve Diseases; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Reoperation; Risk Factors; Tricuspid Valve
PubMed: 33798052
DOI: 10.1532/hsf.3531 -
The Cochrane Database of Systematic... Jul 2013Patients with prosthetic heart valves are at increased risk for valve thrombosis and arterial thromboembolism. Oral anticoagulation alone, or the addition of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Patients with prosthetic heart valves are at increased risk for valve thrombosis and arterial thromboembolism. Oral anticoagulation alone, or the addition of antiplatelet drugs, has been used to minimise this risk. An important issue is the effectiveness and safety of the latter strategy.
OBJECTIVES
This is an update of our previous review; the goal was to create a valid synthesis of all available, methodologically sound data to further assess the safety and efficacy of combined oral anticoagulant and antiplatelet therapy versus oral anticoagulant monotherapy in patients with prosthetic heart valves.
SEARCH METHODS
We updated the previous searches from 2003 and 2010 on 16 January 2013 and searched the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library (2012, Issue 12), MEDLINE (OVID, 1946 to January Week 1 2013), and EMBASE (OVID, 1980 to 2013 Week 02). We have also looked at reference lists of individual reports, review articles, meta-analyses, and consensus statements. We included reports published in any language or in abstract form.
SELECTION CRITERIA
All reports of randomised controlled trials comparing standard-dose oral anticoagulation to standard-dose oral anticoagulation and antiplatelet therapy in patients with one or more prosthetic heart valves.
DATA COLLECTION AND ANALYSIS
Two review authors independently performed the search strategy, assessed trials for inclusion and study quality, and extracted data. We collected adverse effects information from the trials.
MAIN RESULTS
One new study has been identified and included in this update. In total, 13 studies involving 4122 participants were included in this review update. Years of publication ranged from 1971 to 2011. Compared with anticoagulation alone, the addition of an antiplatelet agent reduced the risk of thromboembolic events (odds ratio (OR) 0.43, 95% confidence interval (CI) 0.32 to 0.59; P < 0.00001) and total mortality (OR 0.57, 95% CI 0.42 to 0.78; P = 0.0004). Aspirin and dipyridamole reduced these events similarly. The risk of major bleeding was increased when antiplatelet agents were added to oral anticoagulants (OR 1.58, 95% CI 1.14 to 2.18; P = 0.006).For major bleeding, there was no evidence of heterogeneity between aspirin and dipyridamole and in the comparison of trials performed before and after 1990, around the time when anticoagulation standardisation with the international normalised ratio was being implemented. A lower daily dose of aspirin (< 100 mg) may be associated with a lower major bleeding risk than higher doses.
AUTHORS' CONCLUSIONS
Adding antiplatelet therapy, either dipyridamole or low-dose aspirin, to oral anticoagulation decreases the risk of systemic embolism or death among patients with prosthetic heart valves. The risk of major bleeding is increased with antiplatelet therapy. These results apply to patients with mechanical prosthetic valves or those with biological valves and indicators of high risk such as atrial fibrillation or prior thromboembolic events. The effectiveness and safety of low-dose aspirin (100 mg daily) appears to be similar to higher-dose aspirin and dipyridamole. In general, the quality of the included trials tended to be low, possibly reflecting the era when the majority of the trials were conducted (1970s and 1980s when trial methodology was less advanced).
Topics: Administration, Oral; Anticoagulants; Aspirin; Dipyridamole; Drug Therapy, Combination; Heart Valve Prosthesis; Hemorrhage; Humans; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic; Thromboembolism
PubMed: 23839768
DOI: 10.1002/14651858.CD003464.pub2 -
BJOG : An International Journal of... Oct 2015Historically, pregnancies among women with prosthetic heart valves have been associated with an increased incidence of adverse outcomes. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Historically, pregnancies among women with prosthetic heart valves have been associated with an increased incidence of adverse outcomes.
OBJECTIVES
Systematic review to assess risk of adverse pregnancy outcomes among women with a prosthetic heart valve(s) over the last 20 years.
SEARCH STRATEGY
Electronic literature search of Medline, The Cochrane Library, Cumulative Index to Nursing and Allied Health Literature and Embase to find recent studies.
SELECTION CRITERIA
Studies of pregnant women with heart valve prostheses including trials, cohort studies and unselected case series.
DATA COLLECTION AND ANALYSIS
Primary analysis calculated absolute risks and 95% confidence intervals (CI) for pregnancy outcomes using a random effects model. The Freeman-Tukey transformation was utilised in secondary analysis due to the large number of individual study outcomes with zero events.
MAIN RESULTS
Eleven studies capturing 499 pregnancies among women with heart valve prostheses, including 256 mechanical and 59 bioprosthetic, were eligible for inclusion. Pooled estimate of maternal mortality was 1.2/100 pregnancies (95% CI 0.5-2.2), for mechanical valves subgroup 1.8/100 (95% CI 0.5-3.7) and bioprosthetic subgroup 0.7/100 (95% CI 0.1-4.5), overall pregnancy loss 20.8/100 pregnancies (95% CI 9.5-35.1), perinatal mortality 5.0/100 births (95%CI 1.8-9.8) and thromboembolism 9.3/100 pregnancies (95% CI 4.0-16.5).
CONCLUSIONS
Women with heart valve prostheses experienced higher rates of adverse outcomes than expected in a general obstetric population; however, lower than previously reported. Women with bioprostheses had significantly fewer thromboembolic events compared to women with mechanical valves. Women should be counselled pre-pregnancy about risk of maternal death and pregnancy loss. Vigilant surveillance by a multidisciplinary team throughout the perinatal period remains warranted for these women and their infants.
TWEETABLE ABSTRACT
Metaanalysis suggests improvement in #pregnancy outcomes among women with #heartvalveprostheses.
Topics: Bioprosthesis; Female; Fetal Death; Fetal Mortality; Heart Valve Prosthesis; Humans; Infant, Newborn; Maternal Mortality; Perinatal Mortality; Pregnancy; Pregnancy Complications, Cardiovascular; Pregnancy Outcome; Thromboembolism
PubMed: 26119028
DOI: 10.1111/1471-0528.13491 -
Journal of Cardiac Surgery Sep 2022Prosthetic valve thrombosis (PVT) is a rare but life-threatening complication. Surgery and fibrinolytic therapy (FT) are the two main treatment options for PVT. The... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Prosthetic valve thrombosis (PVT) is a rare but life-threatening complication. Surgery and fibrinolytic therapy (FT) are the two main treatment options for PVT. The choice between surgery and FT has always been a matter of debate. Previous studies have shown that although the mortality rate is higher in surgery, complications are less frequent than in FT. We aimed to perform a systematic review and meta-analysis to compare the results of surgery and FT in PVT.
METHODS
A systematic review of the literature was performed through Medline, Embase, Scopus, and Web of Science, encompassing all studies comparing surgery and FT in PVT. The rate of each complication and risk ratio (RR) of complications in surgery and FT were assessed using random-effects models.
RESULTS
Fifteen studies with 1235 patients were included in the meta-analysis. The pooled risk of the mortality was not significantly different between FT and surgery in patients with PVT (pooled RR = 0.78, 95% confidence interval [CI]: 0.38-1.60, I² = 61.4%). The pooled risks of thromboembolic events (pooled RR = 4.70, 95% CI: 1.83-12.07, I² = 49.6%) and major bleeding (pooled RR = 2.45, 95% CI: 1.09-5.50, I² = 41.1%) and PVT recurrence (pooled RR = 2.06 95% CI: 1.29-3.27, I² = 0.0%) were significantly higher in patients who received FT.
CONCLUSION
Surgery may be safer and with fewer complications than FT for PVT treatment. However, randomized clinical trials are needed to determine the proper treatment for PVT.
Topics: Fibrinolytic Agents; Heart Valve Diseases; Heart Valve Prosthesis; Humans; Thrombolytic Therapy; Thrombosis
PubMed: 35701901
DOI: 10.1111/jocs.16681 -
Journal of the American Heart... Dec 2022Background In the absence of randomized controlled trials, reports from nonrandomized studies comparing valve-in-valve implantation (ViV) to redo surgical aortic valve... (Meta-Analysis)
Meta-Analysis Review
Valve-in-Valve Transcatheter Aortic Valve Replacement Versus Redo Surgical Aortic Valve Replacement for Failed Surgical Aortic Bioprostheses: A Systematic Review and Meta-Analysis.
Background In the absence of randomized controlled trials, reports from nonrandomized studies comparing valve-in-valve implantation (ViV) to redo surgical aortic valve replacement (rAVR) have shown inconsistent results. Methods and Results PubMed/MEDLINE, Google Scholar, and CENTRAL (Cochrane Central Register of Controlled Trials) were searched through December 2021. Meta-Analysis of Observational Studies in Epidemiology guidelines were followed. The protocol was registered at the International Prospective Register of Systematic Reviews. Random effects models were applied. The primary outcomes of interest were short-term and midterm mortality. Secondary outcomes included stroke, myocardial infarction, acute renal failure, and permanent pacemaker implantation, as well as prosthetic aortic valve regurgitation, mean transvalvular gradient, and severe prosthesis-patient mismatch. Of 8881 patients included in 15 studies, 4458 (50.2%) underwent ViV and 4423 (49.8%) rAVR. Short-term mortality was 2.8% in patients undergoing ViV compared with 5.0% in patients undergoing rAVR (risk ratio [RR] 0.55 [95% CI, 0.34-0.91], =0.02). Midterm mortality did not differ in patients undergoing ViV compared with patients undergoing rAVR (hazard ratio, 1.27 [95% CI, 0.72-2.25]). The rate of acute kidney failure was lower following ViV, (RR, 0.54 [95% CI, 0.33-0.88], =0.02), whereas prosthetic aortic valve regurgitation (RR, 4.18 [95% CI, 1.88-9.3], =0.003) as well as severe patient-prothesis mismatch (RR, 3.12 [95% CI, 2.35-4.1], <0.001) occurred more frequently. The mean transvalvular gradient was higher following ViV (standard mean difference, 0.44 [95% CI, 0.15-0.72], =0.008). There were no significant differences between groups with respect to stroke (=0.26), myocardial infarction (=0.93), or pacemaker implantation (=0.21). Conclusions Results of this meta-analysis demonstrate better short-term mortality after ViV compared with rAVR. Midterm mortality was similar between groups. Given the likely selection bias in these individual reports, an adequately powered multicenter randomized clinical trial with sufficiently long follow-up in patients with low-to-intermediate surgical risk is warranted. Registration URL: crd.york.ac.uk/prospero/. Unique identifier: CRD42021228752.
Topics: Humans; Aortic Valve; Transcatheter Aortic Valve Replacement; Bioprosthesis; Reoperation; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Aortic Valve Stenosis; Aortic Valve Insufficiency; Myocardial Infarction; Stroke; Treatment Outcome; Risk Factors; Randomized Controlled Trials as Topic; Multicenter Studies as Topic
PubMed: 36533610
DOI: 10.1161/JAHA.121.024848 -
Acta Cardiologica Nov 2021Mechanical valves and bioprosthetic heart valves are widely used for aortic valve replacement (AVR). Mechanical valves are associated with risk of bleeding because of...
Mechanical valves and bioprosthetic heart valves are widely used for aortic valve replacement (AVR). Mechanical valves are associated with risk of bleeding because of oral anticoagulation, while the durability and structural valve deterioration (SVD) represent the main limitation of the bioprosthetic heart valves. The implantation of bioprosthetic heart valves is increasing precipitously due aging population, and the widespread use of transcatheter aortic valve replacement (TAVR). TAVR has become the standard treatment for intermediate or high surgical risk patients and a reasonable alternative to surgery for low risk patients with symptomatic severe aortic stenosis. Moreover, TAVR is increasingly being used for younger and lower-risk patients with longer life expectancy; therefore it is important to ensure the valve durability for long-term transcatheter aortic valves. Although the results of mid-term durability of the transcatheter heart valves are encouraging, their long-term durability remains largely unknown. This review summarises the definitions, mechanisms, risk factors and assessment of SVD; overviews available data on surgical bioprosthetic and transcatheter heart valves durability.
Topics: Aged; Aortic Valve; Aortic Valve Stenosis; Bioprosthesis; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Prosthesis Design; Prosthesis Failure; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 33302806
DOI: 10.1080/00015385.2020.1858250 -
Journal of Thrombosis and Haemostasis :... Sep 2015To perform a systematic review and meta-analysis of studies evaluating anticoagulation during the early postoperative period following mechanical heart valve... (Comparative Study)
Comparative Study Meta-Analysis Review
OBJECTIVE
To perform a systematic review and meta-analysis of studies evaluating anticoagulation during the early postoperative period following mechanical heart valve implantation.
METHODS
Five literature databases were searched to assess the rates of bleeding and thromboembolic events among patients receiving oral anticoagulation (OAC), both with and without bridging anticoagulation therapy with unfractionated heparin (UFH) or subcutaneous low molecular weight heparin (LMWH). The studies' results were pooled via a mixed effects meta-analysis. Heterogeneity (I(2) ) and publication bias were both evaluated.
RESULTS
Twenty-three studies including 9534 patients were included. The bleeding rates were 1.8% (95% confidence interval CI 1.0-3.3) in the group receiving OAC, 2.2% (95% CI 0.9-5.3) in the OAC + UFH group, and 5.5% (95% CI 2.9-10.4) in the OAC + LMWH group (P = 0.042). The thromboembolic event rate was 2.1% (95% CI 1.5-2.9) in the group receiving OAC, as compared with 1.1% (95% CI 0.7-1.8) when the bridging therapy groups were combined as follows: OAC + UFH and OAC + LMWH (P = 0.035). Most of the analyses showed moderate heterogeneity and negative test results for publication bias.
CONCLUSIONS
Bridging therapy following cardiac valve surgery was associated with a lower thromboembolic event rate, although the difference was small, with considerable overlap of the CIs. Direct comparisons are missing. Bridging therapy with UFH appears to be safe; however, this observation has a risk of bias. Early bridging therapy with LMWH appears to be associated with consistently high bleeding rates across multiple analyses. On the basis of the quality of the included studies, more trials are necessary to establish the clinical relevance of bridging therapy and the safety of LMWH.
Topics: Administration, Oral; Anticoagulants; Case-Control Studies; Cohort Studies; Equipment Design; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Hemorrhage; Heparin; Heparin, Low-Molecular-Weight; Hospital Mortality; Humans; Postoperative Complications; Postoperative Period; Publication Bias; Thromboembolism; Thrombophilia; Treatment Outcome; Warfarin
PubMed: 26178802
DOI: 10.1111/jth.13047