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International Journal of Cardiology Oct 2020Surgical aortic valve replacement has been the treatment of choice for patients with aortic valve disease before the arrival of transcatheter aortic valve replacement... (Meta-Analysis)
Meta-Analysis
AIMS
Surgical aortic valve replacement has been the treatment of choice for patients with aortic valve disease before the arrival of transcatheter aortic valve replacement (TAVI), although limited by degeneration of the bioprosthesis. "Redo" intervention itself is burdened by high risk of complications and valve-in-valve (ViV) TAVI could be a valid strategy of redo for patients with comorbidities.
METHODS AND RESULTS
Two independent reviewers screened all studies investigating patients undergoing ViV TAVI. Mortality at 30 days and at 1 year was the primary end point. Of 286 studies identified, 26 articles were included in this review with a total of 1448 patients. Median age was 78.8 years, 57.7% male. Median STS score and Logistic EuroSCORE were 9.4% and 31.3% respectively. Stenosis (45%) was the leading cause of prosthesis failure. Transfemoral approach was preferred (76%), with a prevalence of balloon expandable valves (73.3%). Mean follow up was 376 days. Overall and cardiovascular mortality at 30 days was 6.5% and 5.5% respectively, while at 1 year it was 14.5% and 8.9% respectively. At meta-regression analysis study year (p < .001), Logistic EuroSCORE (p < .01) and valve diameter ≤ 21 mm (p < .05) at 30 days, and stenosis as reason for failure (p = .05) at 1 year were identified as possible predictors of survival.
CONCLUSIONS
ViV TAVI offers a valid strategy to treat high risk patients with a failure of bioprosthesis with satisfying results in terms of short and mid-term mortality. Future studies are needed to find predictors of long term survival and outcomes in lower risk patients.
Topics: Aged; Aortic Valve; Aortic Valve Stenosis; Bioprosthesis; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Incidence; Male; Risk Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 32470529
DOI: 10.1016/j.ijcard.2020.05.058 -
Heart (British Cardiac Society) Aug 2021The review aims to summarise evidence addressing patients' values, preferences and practical issues on deciding between transcatheter aortic valve insertion (TAVI) and...
The review aims to summarise evidence addressing patients' values, preferences and practical issues on deciding between transcatheter aortic valve insertion (TAVI) and surgical aortic valve replacement (SAVR) for aortic stenosis. We searched databases and grey literature until June 2020. We included studies of adults with aortic stenosis eliciting values and preferences about treatment, excluding medical management or palliative care. Qualitative findings were synthesised using thematic analysis, and quantitative findings were narratively described. Evidence certainty was assessed using CERQual (Confidence in the Evidence from Reviews of Qualitative Research) and GRADE (Grading of Recommendations Assessment, Development and Evaluation). We included eight studies. Findings ranged from low to very low certainty. Most studies only addressed TAVI. Studies addressing both TAVI and SAVR reported on factors affecting patients' decision-making along with treatment effectiveness, instead of trade-offs between procedures. Willingness to accept risk varied considerably. To improve their health status, participants were willing to accept higher mortality risk than current evidence suggests for either procedure. No study explicitly addressed valve reintervention, and one study reported variability in willingness to accept shorter duration of known effectiveness of TAVI compared with SAVR. The most common themes were desire for symptom relief and improved function. Participants preferred minimally invasive procedures with shorter hospital stay and recovery. The current body of evidence on patients' values, preferences and practical issues related to aortic stenosis management is of suboptimal rigour and reports widely disparate results regarding patients' perceptions. These findings emphasise the need for higher quality studies to inform clinical practice guidelines and the central importance of shared decision-making to individualise care fitted to each patient.
Topics: Aortic Valve Stenosis; Decision Making; Heart Valve Prosthesis Implantation; Humans; Patient Preference; Quality-Adjusted Life Years; Risk Adjustment; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 33563630
DOI: 10.1136/heartjnl-2020-318334 -
Annals of Cardiothoracic Surgery Sep 2020The treatment of aortic valve disease is the most common valvular surgery in industrialized nations, with 3-9% of the population over the age of eighty having at least...
BACKGROUND
The treatment of aortic valve disease is the most common valvular surgery in industrialized nations, with 3-9% of the population over the age of eighty having at least moderate aortic stenosis. As transcatheter aortic valve replacement (TAVR) has become more established, newer surgical prostheses have been developed with a variety of anchoring systems that do not rely solely on sutures to hold the valve in an appropriate position. The Edwards Intuity valve is a bovine pericardial prosthesis that is modelled on the widely implanted Perimount MagnaEase aortic prosthesis. The Perceval valve is a bovine pericardial valve attached to a self-expanding nitinol stent, which uses the radial force exerted on the patient's aortic annulus and aortic root by the stent portion to hold the valve in position. This meta-analysis compares the outcomes of comparative studies of these two valve systems.
METHODS
This systematic review and meta-analysis compares the outcomes of rapid deployment valves (RDV) and sutureless valves (SURD) and was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations and guidance. The search strategy interrogated six electronic databases. Outcomes measured included all-cause mortality at latest follow up, stroke, cross-clamp and cardiopulmonary bypass (CPB) times, pacemaker implantation rates, paravalvular leak and post-operative transvalvular gradient.
RESULTS
The search strategy identified 407 unique papers for initial assessment with seven studies qualifying for inclusion in the analysis. The outcomes of 4,076 patients (1,650 RDV, 2,426 SURD) were included. There was no difference in mortality, stroke or moderate or worse paravalvular regurgitation between the two groups. SURD had significantly shorter CPB time by 15.7 minutes [95% confidence interval (CI): 4.2-27.1; P=0.007] and a shorter cross-clamp time by 11.3 minutes (95% CI: 6.3-16.3; P<0.001) compared to RDV. RDV had a lower post-operative transvalvular gradient by 2.5 mmHg (95% CI: 1.2-3.8; P<0.001) and a lower rate of mild paravalvular regurgitation (OR 2.51; 95% CI: 1.435-4.768; P=0.004).
CONCLUSIONS
Both valve types have an adequate safety profile and are comparable to conventional sutured prostheses. There was a significant reduction in cross-clamp and CPB times associated with SURD. This may be of benefit for patients requiring multiple concomitant procedures and increases the utility of minimally invasive valve replacement. However, SURD was associated with higher post-operative transvalvular gradients and a higher incidence of paravalvular regurgitation.
PubMed: 33102175
DOI: 10.21037/acs-2020-surd-27 -
Current Problems in Cardiology Jul 2023Transcatheter mitral valve replacement has become a useful alternative for patients with failed mitral prosthesis or annuloplasty rings who are deemed high risk for redo... (Meta-Analysis)
Meta-Analysis Review
Transcatheter mitral valve replacement has become a useful alternative for patients with failed mitral prosthesis or annuloplasty rings who are deemed high risk for redo surgery. We aimed to compare the clinical outcomes following transseptal (TS) and transapical (TA) approaches in transcatheter mitral valve-in-valve and valve-in-ring implantation (TMViV/R). Electronic databases PubMed, MEDLINE, and Embase were searched through November 2022. Both clinical trials and observational studies comparing patients undergoing TS and TA TMViV/R were eligible for inclusion. Primary outcomes were 30-day and 1-year mortality. Postoperative stroke, left ventricle outlet tract (LVOT) obstruction, mitral valve pressure gradient (MVPG), bleeding, and length of hospital stay were also evaluated. Seven observational studies were included comparing patients undergoing TS (n = 1875) and TA (n = 1120) TMViV/R. The TS group had significantly lower 30-day mortality (OR: 0.66; 95% confidence interval [CI] [0.47, 0.94]; P = 0.02, I² = 0%) and lower one-year mortality risk group (HR: 0.79; 95% CI [0.63, 0.99]; P = 0.04, I² = 0%) compared to the TA group. The TS group had consistent shorter in-hospital stay (MD = -3.79; 95% CI [-5.23, -2.34] days; P < 0.0001, I² = 75%). Postoperative stroke, bleeding and LVOT obstruction tended to be lower in the TS but the results did not reach statistical significance. Postoperative MVPG was similar between both groups. The TS approach has lower early mortality, lower 1-year death hazard, shorter in-hospital stay, and a trend toward lower complication rates when compared to TA TMViV/R. Further controlled trials may support the evidence and provide long-term outcomes.
Topics: Humans; Mitral Valve; Heart Valve Prosthesis Implantation; Treatment Outcome; Cardiac Catheterization; Mitral Valve Insufficiency; Heart Valve Prosthesis; Stroke
PubMed: 36921647
DOI: 10.1016/j.cpcardiol.2023.101684 -
Heart Failure Reviews Jan 2024Tricuspid regurgitation (TR) is the most common valvular pathology after heart transplantation (HTx) and endomyocardial biopsy (EMB) remains responsible for the majority... (Review)
Review
Tricuspid regurgitation (TR) is the most common valvular pathology after heart transplantation (HTx) and endomyocardial biopsy (EMB) remains responsible for the majority of cases due to the high probability of structural valve damage. The aim of the present review was to describe the results of surgical management of severe tricuspid regurgitation through tricuspid valve replacement (TVR) after a previous HTx. A systematic review was conducted by searching Pubmed, ScienceDirect, SciELO, DOAJ, and Cochrane databases until June 2023 for publications reporting patients undergoing TVR surgery after a previous HTx. If no right heart valve surgery was undertaken, or a heterotopic heart transplant was performed, or if the concomitant procedure was performed during the transplant itself, the paper was excluded. Twenty articles met our inclusion criteria out of 1532 potentially eligible studies, with a total of 300 patients. Mean age was 55.1 ± 9.6 years, and 85.1% were male. The mean number of EMB per patient was 31.1 ± 5.5 with a mean time between HTx and TVR of 7.64 ± 3.31 years. Bioprostheses were used in 83.3% of cases and 75.0% of patients with a bioprosthesis were reported as alive at last follow-up. Tricuspid valve repair is a valuable option, but these patients will be susceptible to recurrent TR after EMB. TVR with a bioprosthesis may provide the optimal solution for this subset of patients, as EMB is not feasible with a mechanical valve.
Topics: Humans; Male; Middle Aged; Female; Tricuspid Valve Insufficiency; Tricuspid Valve; Treatment Outcome; Retrospective Studies; Heart Valve Prosthesis; Heart Transplantation; Heart Valve Prosthesis Implantation
PubMed: 37851119
DOI: 10.1007/s10741-023-10364-9 -
Journal of Cardiac Surgery Nov 2021Recent studies suggested higher rates of early structural valve degeneration or reintervention for the Trifecta valve compared to other valves. Thus, we conducted a... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Recent studies suggested higher rates of early structural valve degeneration or reintervention for the Trifecta valve compared to other valves. Thus, we conducted a systematic review and meta-analysis comparing the outcomes of the Trifecta valve and the Perimount valves in patients who underwent a surgical aortic valve replacement (SAVR).
METHODS
All randomized control trials and observational studies which investigated the outcomes of the Trifecta valve and Perimount valves were identified with PubMed and EMBASE. The endpoints were the rates of reintervention and all-cause mortality. Hazard ratios (HRs) for reintervention and all-cause mortality were combined with the random-effects model.
RESULTS
Our search identified 6 eligible observational studies which enrolled a total of 11,135 patients who underwent SAVR with either the Trifecta valve (n = 4932) or Perimount (n = 6203). Pooled analyses demonstrated that the reintervention rates were significantly higher with the Trifecta valve compared with Perimount valves (HR [95% confidence interval {CI}] = 3.16 [1.83-5.46]; p < .0001; I = 40%). In contrast, all-cause mortality was not significantly different between the two groups (HR [95% CI] = 1.09 [0.75-1.58]; p = .32, I = 12%).
CONCLUSION
Our analysis showed that AVR with the Trifecta valve was associated with higher rates of reintervention compared for that with the Perimount valve. Although further long-term randomized trials are warranted, surgeons need to be cautious when choosing a bioprosthetic valve for patients undergoing SAVR.
Topics: Aortic Valve; Aortic Valve Stenosis; Bioprosthesis; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Prosthesis Design; Retrospective Studies
PubMed: 34499386
DOI: 10.1111/jocs.15972 -
Hellenic Journal of Cardiology : HJC =... 2022The ACURATE neo transcatheter aortic valve is a self-expanding device suitable for both transfemoral and transapical approach, but specific groups of patients are... (Review)
Review
The ACURATE neo transcatheter aortic valve is a self-expanding device suitable for both transfemoral and transapical approach, but specific groups of patients are under-represented in clinical trials. We aim to provide a comprehensive systematic review on TAVI with ACURATE neo in those special populations. TAVI in bicuspid aortic valve, TAVI in patients with small aortic annulus, TAVI for pure aortic regurgitation and valve-in-valve procedures, were systematically reviewed. The primary endpoint was device success as defined by VARC-2 criteria. The secondary endpoints were safety and performance outcomes according to VARC-2 consensus document.ACURATE neo exhibited similar outcomes in bicuspid vs tricuspid aortic valve except for pre and post-dilatation rates in one observational study. Lower mean aortic gradient and higher pre-dilatation rates with comparable safety outcomes were described for ACURATE neo when compared to Lotus and Evolut-R for bicuspid aortic valve stenosis. 2 studies compared ACURATE in small aortic annuli. ACURATE neo showed lower transvalvular gradients and lower patient prosthesis mismatch rates compared to Sapien 3 and when compared to Evolut R/ Evolut PRO/ Portico, results were similar except for pre-dilatation rates. 3 studies investigated ACURATE neo for pure aortic regurgitation and one for valve-in-valve procedure and demonstrated safety and efficacy, with the exception of malposition events in patients designated for higher valve deployment in the valve-in-valve implantation study.ACURATE neo valve may be a feasible and safe option for patients with bicuspid anatomy, small aortic annulus, previously implanted bioprosthetic aortic valve and pure aortic regurgitation. REGISTRATION NUMBER: Available at https://osf.io/aus26 (DOI 10.17605/OSF.IO/AUS26).
Topics: Aortic Valve; Aortic Valve Insufficiency; Aortic Valve Stenosis; Bicuspid Aortic Valve Disease; Heart Valve Prosthesis; Humans; Observational Studies as Topic; Prosthesis Design; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 35508295
DOI: 10.1016/j.hjc.2022.04.005 -
Cardiovascular Revascularization... Dec 2020The risk of prosthetic valve endocarditis (PVE) in patients who underwent transcatheter aortic valve replacement (TAVR) is presumed to be high. (Meta-Analysis)
Meta-Analysis
BACKGROUND
The risk of prosthetic valve endocarditis (PVE) in patients who underwent transcatheter aortic valve replacement (TAVR) is presumed to be high.
METHODS
Electronic databases were searched to identify articles comparing the rate of PVE in post-TAVR and post-surgical aortic valve replacement (SAVR) patients. Pooled adjusted odds ratio (OR) was computed using a random-effects model.
RESULTS
A total of 19 studies consisting of 84,288 patients, were identified. There was no significant difference in the odds of PVE between patients undergoing TAVR and SAVR, at 30-day (OR 0.62, 95% confidence interval (CI) 0.20-1.92, p = 0.41), 1-year (OR 0.99 95% CI 0.89-1.11, p = 0.84), 2-year (OR 1.02 95% CI 0.68-1.54, p = 0.92) and 5-year (OR 1.03 95% CI 0.80-1.33, p = 0.81). A subgroup sensitivity analysis also showed no significant inter-group differences in the rate of PVE at all time points, when stratified by the study design (clinical trial vs. observational), type of TAVR valves used (self-expanding bioprosthetic valves vs. balloon expanded bioprosthetic valves) and surgical risk of patients (high vs. intermediate vs. low). There was no heterogeneity (I2 = 0%) in the outcomes of the included studies at 30-day, 1-year and 2-year, while the heterogeneity in studies at 5-year was minimal (I2 = 22%).
CONCLUSIONS
In comparison to SAVR, both short and long-term risk of prosthetic valve endocarditis appears to be identical in patients undergoing TAVR. This risk is unaffected by the type of valve, duration of follow-up, study design and surgical risk of the patients.
Topics: Aortic Valve; Aortic Valve Stenosis; Endocarditis, Bacterial; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Risk Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 32553850
DOI: 10.1016/j.carrev.2020.05.034 -
Thrombosis Research Oct 2022To evaluate the safety and efficacy of perioperative bridging in patients with mechanical heart valves undergoing non-cardiac interventions. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To evaluate the safety and efficacy of perioperative bridging in patients with mechanical heart valves undergoing non-cardiac interventions.
MATERIALS AND METHODS
A systematic research using Medline, EMBASE, and Google Scholar was implemented corresponding to the Preferred Reporting Items for Systematic reviews and Meta-analysis (PRISMA) statement. Data from the eligible studies were obtained and meta-analyzed. Primary endpoints included major bleeding and thromboembolism. Secondary endpoints included minor bleeding, overall mortality, and overall bleeding (major and minor bleeding). We conducted a comparative analysis between bridging and non-bridging along with a sensitivity analysis for patients undergoing major and minor operations.
RESULTS
Fifteen studies comprised of 2305 patients (2453 bridging episodes) were included. Pooled major bleeding and thromboembolism rates were 3.85 % (95 % CI: 2.12-5.98) (I = 69 %, p < 0.01) and 0.39 % (95 % CI: 0.00-1.41) (I = 64 %, p < 0.01). Bridging versus non-bridging major bleeding, thromboembolism, and overall bleeding risk ratios (RR) were RR 2.05 (95 % CI: 0.98-4.28) (I = 10 %, p = 0.34), RR 1.63 (95 % CI: 0.41-6.50) (I = 0 %, p = 0.63) and RR 1.79 (95 % CI: 1.17-2.72) (I = 55 %, p = 0.09) respectively. Subgroup analysis displayed major and minor operation thromboembolism and overall bleeding rates of 3.09 % (95 % CI: 0.78-6.43) (I = 0 %, p = 0.89) versus 0.14 % (95 % CI: 0.00-1.40) (I = 0 %, p = 0.93), test for subgroup differences (p < 0.01) and 17.37 % (95 % CI: 11.73-23.77) (I = 0 %, p = 0.61) versus 28.18 % (95 % CI: 22.80-33.88) (I = 0 %, p = 0.47), test for subgroup differences (p = 0.01) respectively.
CONCLUSION
Our analysis suggests that bridging may potentially put patients at an increased bleeding risk regarding overall bleeding rates, while failing to provide statistically significant benefits concerning thromboembolism and overall mortality compared to non-bridging. Limitations such as the mixed patient population don't allow for definite conclusions to be drawn warrantying further research through randomized controlled trials.
Topics: Anticoagulants; Heart Valve Prosthesis; Heart Valves; Hemorrhage; Humans; Thromboembolism
PubMed: 36037548
DOI: 10.1016/j.thromres.2022.08.022 -
Journal of Cardiac Surgery Jul 2021With the growing contemporary use of bioprosthetic valves, whose limited long-term durability has been well-documented, an increase in the need for reintervention is... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND/AIM
With the growing contemporary use of bioprosthetic valves, whose limited long-term durability has been well-documented, an increase in the need for reintervention is expected. We perform a meta-analysis to compare the current standard of care, redo surgical aortic valve replacement (Redo SAVR) with the less invasive alternative, valve-in-valve transcatheter aortic valve replacement (ViV TAVR) for treating structural valve deterioration.
METHODS
After a comprehensive literature search, studies comparing ViV TAVR to Redo SAVR were pooled to perform a pairwise meta-analysis using the random-effects model. Primary outcomes were 30-day and follow-up mortality.
RESULTS
A total of nine studies including 9127 patients were included. ViV TAVR patients were significantly older (mean difference [MD], 5.82; p = .0002) and more frequently had hypercholesterolemia (59.7 vs. 60.0%; p = .0006), coronary artery disease (16.1 vs. 16.1%; p = .04), periphery artery disease (15.4 vs. 5.7%; p = .004), chronic obstructive pulmonary disease (29.3 vs. 26.2%; p = .04), renal failure (30.2 vs. 24.0%; p = .009), and >1 previous cardiac surgery (23.6 vs. 15.9%; p = .004). Despite this, ViV TAVR was associated with decreased 30-day mortality (OR, 0.56; p < .0001). Conversely, Redo SAVR had lower 30-day paravalvular leak (OR, 6.82; p = .04), severe patient-prosthesis mismatch (OR, 3.77; p < .0001), and postoperative aortic valve gradients (MD, 5.37; p < .0001). There was no difference in follow-up mortality (HR, 1.02; p = .86).
CONCLUSIONS
Despite having patients with an increased baseline risk, ViV TAVR was associated with lower 30-day mortality, while Redo SAVR had lower paravalvular leak, severe patient-prosthesis mismatch, and postoperative gradients. Although ViV TAVR remains a feasible treatment option in high-risk patients, randomized trials are necessary to elucidate its efficacy over Redo SAVR.
Topics: Aortic Valve; Aortic Valve Stenosis; Bioprosthesis; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Reoperation; Risk Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 33797799
DOI: 10.1111/jocs.15546