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International Journal of Surgery... Jun 2024The efficacy of mitral valve repair (MVR) in combination with coronary artery bypass grafting (CABG) for moderate ischaemic mitral regurgitation (IMR) remains unclear.... (Meta-Analysis)
Meta-Analysis
Efficacy of mitral valve repair in combination with coronary revascularization for moderate ischaemic mitral regurgitation: a systematic review and meta-analysis of randomized controlled trials.
BACKGROUND
The efficacy of mitral valve repair (MVR) in combination with coronary artery bypass grafting (CABG) for moderate ischaemic mitral regurgitation (IMR) remains unclear. To evaluate whether MVR + CABG is superior to CABG alone, the authors conducted a systematic review and meta-analysis of existing randomized controlled trials (RCTs).
METHODS
The authors searched PubMed, Web of Science, and the Cochrane Central Register of Controlled Trials for eligible RCTs from the date of their inception to October 2023. The primary outcomes were operative (in-hospital or within 30 days) and long-term (≥ 1 year) mortality. The secondary outcomes were postoperative stroke, worsening renal function (WRF), and reoperation for bleeding or tamponade. The authors performed random-effects meta-analyses and reported the results as risk ratios (RRs) with 95% CIs.
RESULTS
Six RCTs were eligible for inclusion. Compared with CABG alone, MVR + CABG did not increase the risk of operative mortality (RR, 1.244; 95% CI, 0.514-3.014); however, it was also not associated with a lower risk of long-term mortality (RR, 0.676; 95% CI, 0.417-1.097). Meanwhile, there was no difference between the two groups in terms of postoperative stroke (RR, 2.425; 95% CI, 0.743-7.915), WRF (RR, 1.257; 95% CI, 0.533-2.964), and reoperation for bleeding or tamponade (RR, 1.667; 95% CI, 0.527-5.270).
CONCLUSIONS
The findings of this meta-analysis suggest that MVR + CABG fails to improve the clinical outcomes of patients with moderate IMR compared to CABG alone.
Topics: Humans; Mitral Valve Insufficiency; Randomized Controlled Trials as Topic; Coronary Artery Bypass; Mitral Valve; Treatment Outcome; Heart Valve Prosthesis Implantation; Myocardial Ischemia
PubMed: 38502857
DOI: 10.1097/JS9.0000000000001277 -
International Journal of Surgery... May 2024This study aims to investigate the effect of concomitant tricuspid valve surgery (TVS) during left ventricular assist device (LVAD) implantation due to the controversy... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
This study aims to investigate the effect of concomitant tricuspid valve surgery (TVS) during left ventricular assist device (LVAD) implantation due to the controversy over the clinical outcomes of concomitant TVS in patients undergoing LVAD.
METHODS
A systematic literature search was performed in PubMed and EMbase from the inception to 1 August 2023. Studies comparing outcomes in adult patients undergoing concomitant TVS during LVAD implantation (TVS group) and those who did not (no-TVS group) were included. The primary outcomes were right heart failure (RHF), right ventricular assist device (RVAD) implantation, and early mortality. All meta-analyses were performed using random-effects models, and a two-tailed P <0.05 was considered significant.
RESULTS
Twenty-one studies were included, and 16 of them were involved in the meta-analysis, with 660 patients in the TVS group and 1291 in the no-TVS group. Patients in the TVS group suffered from increased risks of RHF [risk ratios (RR)=1.31, 95% CI: 1.01-1.70, P =0.04; I2 =38%, pH =0.13), RVAD implantation (RR=1.56, 95% CI: 1.16-2.11, P =0.003; I2 =0%, pH =0.74), and early mortality (RR=1.61, 95% CI: 1.07-2.42, P =0.02; I2 =0%, pH =0.75). Besides, the increased risk of RHF holds true in patients with moderate to severe tricuspid regurgitation (RR=1.36, 95% CI: 1.04-1.78, P =0.02). TVS was associated with a prolonged cardiopulmonary bypass time. No significant differences in acute kidney injury, reoperation requirement, hospital length of stay, or ICU stay were observed.
CONCLUSIONS
Concomitant TVS failed to show benefits in patients undergoing LVAD, and it was associated with increased risks of RHF, RVAD implantation, and early mortality.
Topics: Humans; Heart-Assist Devices; Tricuspid Valve; Heart Failure; Tricuspid Valve Insufficiency; Heart Valve Prosthesis Implantation
PubMed: 38348836
DOI: 10.1097/JS9.0000000000001189 -
European Journal of Cardio-thoracic... Feb 2024While current data show a clear trend towards the use of bioprosthetic valves during aortic valve replacement (AVR), durability of bioprosthetic valves remains the most... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
While current data show a clear trend towards the use of bioprosthetic valves during aortic valve replacement (AVR), durability of bioprosthetic valves remains the most important concern. We conducted a 1st systematic review of all available evidence that analysed early and mid-term outcomes after AVR using the Inspiris RESILIA™ bioprosthesis.
METHODS
A systematic literature search was performed to identify all relevant studies evaluating early and mid-term outcomes after AVR using the Inspiris RESILIA bioprosthesis and including at least 20 patients with no restriction on the publication date. Subgroup meta-analysis was performed to compare Inspiris RESILIA and PERIMOUNT Magna Ease bioprosthesis and to pool the early postoperative mortality and stroke rates.
RESULTS
A total of 416 studies were identified, of which 15 studies met the eligibility criteria. The studies included a total of 3202 patients with an average follow-up of up to 5.3 years. The average age of patients across the studies was 52.2-75.1 years. Isolated AVR was performed in 39.0-86.4% of patients. In-hospital or 30-day postoperative mortality was 0-2.8%. At the mid-term follow-up, freedom from all-cause mortality was up to 85.4%. Among studies with mid-term follow-up, trace/mild paravalvular leak was detected in 0-3.0%, while major paravalvular leak was found only in up to 2.0% of patients. No statistically significant differences in terms of mortality (P = 0.98, odds ratio 1.02, 95% confidence interval 0.36-2.83) and stroke (P = 0.98, odds ratio 1.01, 95% confidence interval 0.38-2.73) between the Inspiris RESILIA bioprosthesis and PERIMOUNT Magna Ease bioprosthesis were observed in the subgroup meta-analysis.
CONCLUSIONS
Mid-term data on the safety and haemodynamic performance of the novel aortic bioprosthesis are encouraging. Further comparative studies with other bioprostheses and longer follow-up are still required to endorse durability and safety of the novel bioprosthesis.
Topics: Humans; Middle Aged; Aged; Aortic Valve; Bioprosthesis; Heart Valve Prosthesis Implantation; Heart Valve Prosthesis; Stroke; Prosthesis Design; Treatment Outcome; Retrospective Studies
PubMed: 38331412
DOI: 10.1093/ejcts/ezae045 -
Current Problems in Cardiology Mar 2024A systematic review of the literature was conducted to analyze the current evidence on low-flow, low-gradient severe aortic stenosis. This analysis aimed to... (Review)
Review
OBJECTIVES
A systematic review of the literature was conducted to analyze the current evidence on low-flow, low-gradient severe aortic stenosis. This analysis aimed to differentiate between subgroups of patients with reduced and preserved left ventricular ejection fraction (LVEF).
METHODS
After conducting a systematic literature review, 35 observational studies were included. Out of these, 28 were prospective and 7 retrospective. The studies that included a mortality risk stratification of low-flow, low-gradient aortic stenosis (LF- LG AS) with both preserved and reduced LVEF were reviewed.
RESULTS
The importance of considering multiple clinical and echocardiographic variables in diagnostic evaluation and therapeutic decision-making was highlighted.
CONCLUSIONS
LF- LG AS, in any of its subgroups, is a common and challenging valve lesion. A careful assessment of severity and, in specific scenarios, a thorough reclassification is important. More high-quality studies are required to more precisely define the classification and prognosis of this entity.
Topics: Humans; Stroke Volume; Ventricular Function, Left; Retrospective Studies; Prospective Studies; Aortic Valve Stenosis; Severity of Illness Index; Aortic Valve; Heart Valve Prosthesis Implantation
PubMed: 38232925
DOI: 10.1016/j.cpcardiol.2024.102392 -
Cardiovascular Revascularization... May 2024Percutaneous closure of aortic and ventricular pseudoaneurysms (PSA) has only been reported on a case report and series basis. In previous case reports, percutaneous... (Review)
Review
Contemporary experience of percutaneous management of complex aortic and ventricular pseudoaneurysms associated to perivalvular leak: A case series and review of literature.
BACKGROUND
Percutaneous closure of aortic and ventricular pseudoaneurysms (PSA) has only been reported on a case report and series basis. In previous case reports, percutaneous closure has been performed successfully in patients of prohibitive surgical risk. This case series aims to show feasibility of percutaneous closure of aortic and ventricular pseudoaneurysm secondary to perivalvular leak (PVL) in a small patient population and the utility of multimodality imaging as an integral tool in procedural planning. This is the largest complex case series to date describing the feasibility and success rate of complex PSA closure, with a follow-up period of up to 4 years.
MATERIAL AND METHODS
We performed institutional review and systemic literature review to identify all paravalvular leak cases with associated pseudoaneurysm formation for which a closure procedure was performed. Ten patients were identified. Pooled analysis for cases from institutional review (n = 10) and systemic literature review (n = 39) was performed. The success rate was 100 %. At 30-days, the mortality was 0 %.
CONCLUSION
In paravalvular leak patients with subsequent pseudoaneurysm formation, exhaustive imaging evaluation is required for closure. However, it can be achievable with favorable rates of success.
Topics: Humans; Aneurysm, False; Male; Female; Treatment Outcome; Aged; Middle Aged; Heart Valve Prosthesis Implantation; Heart Aneurysm; Cardiac Catheterization; Aortic Aneurysm; Time Factors; Aged, 80 and over; Heart Valve Prosthesis; Aortic Valve; Echocardiography, Transesophageal; Adult
PubMed: 38212236
DOI: 10.1016/j.carrev.2023.12.006 -
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 -
Catheterization and Cardiovascular... Feb 2024There is currently little evidence for transcatheter edge-to-edge mitral valve repair (TEER) for mitral regurgitation (MR) in patients with cardiogenic shock (CS).... (Meta-Analysis)
Meta-Analysis
BACKGROUND
There is currently little evidence for transcatheter edge-to-edge mitral valve repair (TEER) for mitral regurgitation (MR) in patients with cardiogenic shock (CS). Therefore, this study investigated the characteristics and outcomes of CS patients who underwent TEER for MR.
METHODS
PubMed, EMBASE were searched in July 2023. Case series and observational studies reporting clinical characteristics and outcomes in CS patients with MR who underwent TEER were included. We performed a one-group meta-analysis using a random effects model.
RESULTS
A total of 4060 patients from 7 case series and 5 observational studies were included. The mean age was 68.2 (95% confidence interval [CI]: 64.1-72.2) years, and 41.4% of patients (95% CI: 39.1%-43.7%) were female. Pre-TEER, severe MR was present in 85.3% (95% CI: 76.1%-91.3%) of patients. Mean left ventricular ejection fraction was 36.7% (95% CI: 29.2%-44.2%), and 54.6% (95% CI: 36.9%-71.2%) of patients received mechanical circulatory support. The severity of MR post-TEER was less than 2+ in 88% (95% CI: 87%-89%) of patients. In-hospital mortality was 11% (95% CI: 10%-13%), whereas 30-day and 1-year mortality rates were 15% (95% CI: 13%-16%), and 36% (95% CI: 21%-54%), respectively.
CONCLUSIONS
This systematic review and meta-analysis assessed the clinical characteristics and outcomes of TEER in CS patients with MR. TEER for MR in patients with CS has been successful in reducing MR in most of the patients, but with a high mortality rate. Randomized controlled trials of TEER for MR and CS are needed.
Topics: Humans; Female; Aged; Male; Mitral Valve; Mitral Valve Insufficiency; Shock, Cardiogenic; Stroke Volume; Ventricular Function, Left; Treatment Outcome; Heart Valve Prosthesis Implantation
PubMed: 38156508
DOI: 10.1002/ccd.30944 -
Current Problems in Cardiology Mar 2024Transcatheter aortic valve implantation (TAVI) is a common practice for severe aortic stenosis, but the choice between general (GA) and local anesthesia (LA) remains... (Meta-Analysis)
Meta-Analysis Review
Local versus General Anaesthesia for Transcatheter Aortic Valve Implantation (TAVI): A Systematic Review, Meta-Analysis, and Trial Sequential Analysis of Randomised and Propensity-Score Matched Studies.
Transcatheter aortic valve implantation (TAVI) is a common practice for severe aortic stenosis, but the choice between general (GA) and local anesthesia (LA) remains uncertain. We conducted a comprehensive literature review until April 2023, comparing the safety and efficacy of LA versus GA in TAVI procedures. Our findings indicate significant advantages of LA, including lower 30-day mortality rates (RR: 0.69; 95% CI [0.58, 0.82]; p < 0.001), shorter in-hospital stays (mean difference: -0.91 days; 95% CI [-1.63, -0.20]; p = 0.01), reduced bleeding/transfusion incidents (RR: 0.64; 95% CI [0.48, 0.85]; p < 0.01), and fewer respiratory complications (RR: 0.56; 95% CI [0.42, 0.76], p<0.01). Other operative outcomes were comparable. Our findings reinforce prior evidence, presenting a compelling case for LA's safety and efficacy. While patient preferences and clinical nuances must be considered, our study propels the discourse towards a more informed anaesthesia approach for TAVI procedures.
Topics: Humans; Transcatheter Aortic Valve Replacement; Aortic Valve Stenosis; Treatment Outcome; Anesthesia, General; Anesthesia, Local; Aortic Valve; Heart Valve Prosthesis Implantation; Risk Factors
PubMed: 38128636
DOI: 10.1016/j.cpcardiol.2023.102360 -
The American Journal of Cardiology Feb 2024Mitral valve repair (MVr) has been associated with superior long-term survival and freedom from valve-related complications compared with mitral valve replacement for... (Meta-Analysis)
Meta-Analysis
Mitral valve repair (MVr) has been associated with superior long-term survival and freedom from valve-related complications compared with mitral valve replacement for primary mitral regurgitation (MR). The 2 main approaches for MVr are chordal replacement ("respect approach") and leaflet resection ("resect approach"). We performed a systematic review and a meta-analysis using 3 search databases to compare the long-term end points between both approaches. The primary end point was long-term survival. The secondary end points were long-term MR recurrence and reoperation. After reconstruction of time-to-event data for the individual survival analysis, pooled Kaplan-Meier curves for the end points were generated. A total of 14 studies (5,565 patients) were included in the analysis. The respect approach was associated with superior survival compared with the resect approach in the overall sample (hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.56 to 0.96, p = 0.024, n = 3,901 patients) but not in the risk-adjusted sample (HR 1.00, 95% CI 0.55 to 1.82, p = 0.991, n = 620 patients). There was no difference between the approaches in the rate of MR recurrence in the overall sample (HR 1.39, 95% CI 0.92 to 2.08, p = 0.116, n = 1,882 patients) or in the risk-adjusted sample (HR 1.62, 95% CI 0.76 to 3.47, p = 0.211, n = 288 patients). The data for reoperation were only available in the overall sample and did not reveal a difference (HR 0.92, 95% CI 0.62 to 1.35, p = 0.663, n = 3,505 patients). In conclusion, the current evidence suggests no difference in long-term mortality, MR recurrence, or reoperation between the resect and respect approaches for MVr after adjusting for patient risk factors. More long-term follow-up data are warranted.
Topics: Humans; Heart Valve Prosthesis Implantation; Mitral Valve; Mitral Valve Annuloplasty; Mitral Valve Insufficiency; Neoplasm Recurrence, Local; Reoperation; Treatment Outcome
PubMed: 38104750
DOI: 10.1016/j.amjcard.2023.12.010 -
Journal of Cardiothoracic Surgery Nov 2023The aim of this review was the creation of uniform protocols to carry out and disclose First-In-Human and preliminary clinical trials of biological mitral valve... (Review)
Review
BACKGROUND
The aim of this review was the creation of uniform protocols to carry out and disclose First-In-Human and preliminary clinical trials of biological mitral valve replacement. The need for consistent methodology in these early trials was highlighted by the observation of significant variability in the methods and protocols used across different research.
METHODS
An extensive search through six major databases was carried out to retrieve First-In-Human (FIH) clinical studies evaluating surgically implanted bio-prostheses in the mitral position.
RESULTS
Following the PRISMA guideline, a systematic search identified 2082 published articles until March 2023. After removing duplicates (189), 1862 citations were screened, resulting in 22 eligible studies with 3332 patients for analysis. The mitral valve prostheses in these studies ranged from 21 to 37 mm, with the 29 mm size being most prevalent. Patient numbers varied, with the FIH subgroup including 31 patients and the older subgroup including 163 patients. Average study durations differed: the older subgroup lasted 4.57 years, the FIH subgroup 2.85 years, and the early phase studies spanned 8.05 years on average.
CONCLUSION
FIH clinical report is essential to assess the significance of clinical data required for a "de novo" surgical implant. In addition, understanding the performance of the device, and recognizing the difficulties associated with the innovation constitute important lessons. These insights could be beneficial for the development of bioprosthetic heart valves and formulating a protocol for an FIH clinical trial.
Topics: Humans; Mitral Valve; Prosthesis Design; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Bioprosthesis; Prosthesis Failure
PubMed: 38037117
DOI: 10.1186/s13019-023-02464-2