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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 -
Infection Oct 2023Progress of interventional cardiology has boosted the use of newer cardiac devices. These devices are perceived to be less prone to infections compared to traditional... (Review)
Review
PURPOSE
Progress of interventional cardiology has boosted the use of newer cardiac devices. These devices are perceived to be less prone to infections compared to traditional surgical prostheses, but little data are currently available. In this systematic review (SR), we summarize current literature regarding the clinical characteristics, management, and outcomes of patients with MitraClip-related infective endocarditis (IE).
METHODS
We conducted a SR of PubMed, Google Scholar, Embase, and Scopus between January 2003 and March 2022. MitraClip-related IE was defined according to 2015 ESC criteria whereas MitraClip involvement as vegetation on the device or on the mitral valve. Risk of bias was assessed through standardized checklist and potential bias of underestimation cannot be excluded. Data regarding clinical presentation, echocardiography, management, and outcome were collected.
RESULTS
Twenty-six cases of MitraClip-related IE were retrieved. The median age of patients was 76 [61-83] years with a median EuroScore of 41%. Fever was present in 65.8% of patients followed by signs and symptoms of heart failure (42.3%). IE occurred early in 20 (76.9%) cases with a median time between MitraClip implantation and IE symptom onset of 5 [2-16] months. Staphylococcus aureus was the major causative microorganism (46%). Surgical mitral valve replacement was needed in 50% of patients. A conservative medical approach was considered in the remainder. The overall in-hospital mortality rate was 50% (surgical group: 38.4%; medical group: 58.3%; p = 0.433).
CONCLUSION
Our results suggest that MitraClip-related IE affects elderly, comorbid patients, is mostly due to Staphylococcus aureus, and has a poor prognosis irrespective of the therapeutic approach. Clinicians must be aware of the features of this new entity among cardiovascular infections.
Topics: Humans; Aged; Middle Aged; Aged, 80 and over; Heart Valve Prosthesis; Treatment Outcome; Endocarditis, Bacterial; Endocarditis; Mitral Valve; Mitral Valve Insufficiency
PubMed: 37386329
DOI: 10.1007/s15010-023-02067-y -
Procedural safety of transcatheter aortic valve replacement with Portico valve: a systematic review.International Journal of Surgery... Nov 2023The Portico transcatheter aortic heart valve is a self-expandable, fully resheathable bioprosthetic valve with a nitinol frame and porcine pericardial sealing cuff. It...
BACKGROUND
The Portico transcatheter aortic heart valve is a self-expandable, fully resheathable bioprosthetic valve with a nitinol frame and porcine pericardial sealing cuff. It has been used among symptomatic severe aortic stenosis (AS) who are at high or extreme surgical risk. However, till date very few studies has been reported with inconclusive evidence for its postprocedure safety outcomes.
OBJECTIVE
The authors aim to evaluate the safety of the Portico transcatheter aortic valve replacement system among patients with AS.
METHODOLOGY
The authors conducted a systematic literature search on PubMed, Embase, and Scopus from inception till 10th April 2023 by using predefined MESH terms using 'AND' and 'OR'. The following search terms were used: 'Aortic Stenosis' AND 'Transcatheter aortic valve replacement' OR 'Portico valve'. Finally, descriptive statistics were used to summarize the data in this paper. The mean and SD were adopted to describe continuous variables, whereas frequencies and percentages were used for dichotomous data.
RESULTS
A total of 7 studies with 2782 patients were included in the analysis. The mean age of patients was 82.3 years, and 54.63% were female. The most common comorbidity was hypertension (65.21%) and diabetes mellitus (26.45%). Among patients of AS with Portico valve implants, postprocedural outcomes including 30-day mortality (2.32%), cardiovascular mortality (2.37%), stroke (2.23%), myocardial infarction (0.94%), major bleeding (3.97%), major vascular complications (4.91%), acute kidney injury (1.37%), and permanent pacemaker implantations in 15.73% patients were reported. Overall, device success was observed in 95.82% of patients.
CONCLUSION
Transcatheter aortic valve replacement with the repositionable Portico valve, a new bioprosthesis, appears to have a low postprocedural mortality rate and other clinical outcomes in high-risk patients with severe AS.
Topics: Humans; Female; Animals; Swine; Aged, 80 and over; Male; Transcatheter Aortic Valve Replacement; Aortic Valve; Treatment Outcome; Postoperative Complications; Aortic Valve Stenosis; Heart Valve Prosthesis; Prosthesis Design
PubMed: 37581642
DOI: 10.1097/JS9.0000000000000645 -
International Journal of Surgery... Aug 2023Whether there are differences among the new-generation transcatheter aortic valve implantation (TAVI) devices for patients with aortic stenosis remains unclear. The aim... (Meta-Analysis)
Meta-Analysis
Comparisons of different new-generation transcatheter aortic valve implantation devices for patients with severe aortic stenosis: a systematic review and network meta-analysis.
BACKGROUND
Whether there are differences among the new-generation transcatheter aortic valve implantation (TAVI) devices for patients with aortic stenosis remains unclear. The aim of the study was to compare the efficiency and safety of different new-generation TAVI devices for patients with aortic stenosis.
MATERIALS AND METHODS
A comprehensive search of PubMed, Embase and Web of Science from their inception to 1 February 2022. Randomized clinical trials and observational studies that compared two or more different TAVI devices were enroled. Pairwise meta-analysis and frequentist network meta-analysis were conducted to pool the outcome estimates of interest.
RESULTS
A total of 79 studies were finally included. According to the surface under the cumulative ranking, the top two ranked valves for lower rates of events were as follows: direct flow medical (DFM) (4.6%) and Lotus (48.8%) for lower rate of device success; Sapien 3 (16.8%) and DFM (19.7%) for lower mortality; DFM (8.6%) and Sapien 3 (25.5%) for lower rates of stroke; Evolut (27.6%) and DFM (35.8%) for lower rates of major and life-threatening bleeding; Portico (22.6%) and Sapien 3 (41.9%) for lower rates of acute kidney injury; Acurate (8.6%) and DFM (13.2%) for lower rates of permanent pacemaker implantation; Lotus (0.3%) and Sapien 3 (22.7%) for lower rates of paravalvular leak; Evolut (1.4%) and Portico (29.1%) for lower rates of mean aortic valve gradients.
CONCLUSIONS
The findings of the present study suggested that the device success rates were comparable among these new-generation valves except for DFM. After excluding DFM, Sapien 3 might be the best effective for decreased mortality and stroke; Lotus might be the best effective for decreased paravalvular leak; Evolut might be the best effective for decreased major and life-threatening bleeding and mean aortic valve gradients; Acurate and Portico might be the best effective for decreased permanent pacemaker implantation and acute kidney injury, respectively.
Topics: Humans; Transcatheter Aortic Valve Replacement; Aortic Valve; Network Meta-Analysis; Postoperative Complications; Treatment Outcome; Heart Valve Prosthesis; Prosthesis Design; Severity of Illness Index; Aortic Valve Stenosis; Stroke; Acute Kidney Injury
PubMed: 37161443
DOI: 10.1097/JS9.0000000000000456 -
International Journal of Antimicrobial... Jan 2024Adjunctive rifampicin for implant-associated infections is controversial. This study investigated the clinical outcomes of rifampicin combination therapy compared with... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Adjunctive rifampicin for implant-associated infections is controversial. This study investigated the clinical outcomes of rifampicin combination therapy compared with monotherapy in treating prosthetic joint infection (PJI) or prosthetic valve endocarditis (PVE) due to staphylococci and streptococci.
METHODS
A systematic search was performed from inception to 13 June 2022 in Embase, MEDLINE, Cochrane and Web of Science to investigate the clinical outcomes of rifampicin combination therapy compared with monotherapy in treating staphylococcal and streptococcal PJI or PVE. Randomised controlled trials (RCTs) and observational studies were included in the systematic review and meta-analysis.
RESULTS
Fourteen studies were included. A moderate quality of evidence was found in favour of rifampicin in patients with staphylococcal PJI who underwent a debridement, antibiotics and implant retention (DAIR) procedure [odds ratio = 2.49, 95% confidence interval (CI) 1.93-3.23]. Including the two RCTs only, adding rifampicin to the antibiotic regimen after DAIR was also in favour of rifampicin, but this was not statistically significant (risk ratio = 1.27, 95% CI 0.79-2.04; n = 126). Pooling data for patients with staphylococcal PJI who underwent a two-stage procedure showed that adding rifampicin was not associated with therapeutic success. Limited evidence was found for the use of rifampicin for PVE caused by staphylococci.
CONCLUSIONS
Adding rifampicin in the treatment of staphylococcal PJI treated by DAIR clearly increased the likelihood for therapeutic success. The clinical benefit of adjunctive rifampicin in the treatment of other staphylococci and streptococci implant-associated infections is still unclear.
Topics: Humans; Anti-Bacterial Agents; Arthritis, Infectious; Debridement; Prosthesis-Related Infections; Retrospective Studies; Rifampin; Staphylococcus; Streptococcus; Treatment Outcome
PubMed: 37875179
DOI: 10.1016/j.ijantimicag.2023.107015 -
European Heart Journal. Quality of Care... Aug 2023Standardized data definitions are necessary for the quantification of quality of care and patient outcomes in observational studies and randomised controlled trials...
AIMS
Standardized data definitions are necessary for the quantification of quality of care and patient outcomes in observational studies and randomised controlled trials (RCTs). The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology (ESC) aims to create pan-European data standards for cardiovascular diseases and interventions, including transcatheter aortic valve implantation (TAVI).
METHODS AND RESULTS
We followed the EuroHeart methodology for cardiovascular data standard development. A Working Group of 29 members representing 12 countries was established and included a patient representative, as well as experts in the management of valvular heart disease from the European Association of Percutaneous Cardiovascular Interventions (EAPCI), the European Association of Cardiovascular Imaging (EACVI) and the Working Group on Cardiovascular Surgery. We conducted a systematic review of the literature and used a modified Delphi method to reach consensus on a final set of variables. For each variable, the Working Group provided a definition, permissible values, and categorized the variable as mandatory (Level 1) or additional (Level 2) based on its clinical importance and feasibility. In total, 93 Level 1 and 113 Level 2 variables were selected, with the level 1 variables providing the dataset for registration of patients undergoing TAVI on the EuroHeart IT platform.
CONCLUSION
This document provides details of the EuroHeart data standards for TAVI processes of care and in-hospital outcomes. In the context of EuroHeart, this will facilitate quality improvement, observational research, registry-based RCTs and post-marketing surveillance of devices, and pharmacotherapies.
ONE-SENTENCE SUMMARY
The EuroHeart data standards for transcatheter aortic valve implantation (TAVI) are a set of internationally agreed data variables and definitions that once implemented will facilitate improvement of quality of care and outcomes for patients receiving TAVI.
Topics: Humans; Transcatheter Aortic Valve Replacement; Aortic Valve; Aortic Valve Stenosis; Heart Valve Prosthesis Implantation; Registries; Randomized Controlled Trials as Topic
PubMed: 36195332
DOI: 10.1093/ehjqcco/qcac063 -
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 -
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 -
BMC Cardiovascular Disorders Aug 2023Minimally invasive approaches like mini-thoracotomy and mini-sternotomy for Aortic Valve Replacement (AVR) showed impressive outcomes. However, their advantages for... (Meta-Analysis)
Meta-Analysis
Comparative effects of minimally invasive approaches vs. conventional for obese patients undergoing aortic valve replacement: a systematic review and network meta-analysis.
BACKGROUND
Minimally invasive approaches like mini-thoracotomy and mini-sternotomy for Aortic Valve Replacement (AVR) showed impressive outcomes. However, their advantages for obese patients are questionable. We aimed in this network meta-analysis to compare three surgical approaches: Full sternotomy (FS), Mini-sternotomy (MS), and Mini-thoracotomy (MT) for obese patients undergoing AVR.
METHODS
We followed the PRISMA extension for this network meta-analysis. PubMed/Medline, Scopus, Web of Science, and Cochrane searched through March 2023 for relevant articles. The analysis was performed using R version 4.2.3.
RESULTS
Out of 344, 8 articles met the criteria with 1392 patients. The main outcomes assessed were perioperative mortality, re-exploration, atrial fibrillation, renal failure, ICU stay, hospital stay, cross-clamp time, and bypass time. In favor of MS, the length of ICU stay and hospital stay was significantly lower than for FS [MD -0.84, 95%CI (-1.26; -0.43)], and [MD -2.56, 95%CI (-3.90; -1.22)], respectively. Regarding peri-operative mortality, FS showed a significantly higher risk compared to MS [RR 2.28, 95%CI (1.01;5.16)]. Also, patients who underwent minimally invasive approaches; MT and MS, required less need of re-exploration compared to FS [RR 0.10, 95%CI (0.02;0.45)], and [RR 0.33, 95%CI (0.14;0.79)], respectively. However, Intraoperative timings; including aortic cross-clamp, and cardiopulmonary bypass time, were significantly lower with FS than for MS [MD -9.16, 95%CI (-1.88; -16.45)], [MD -9.61, 95%CI (-18.64; -0.59)], respectively.
CONCLUSION
Our network meta-analysis shows that minimally invasive approaches offer some advantages for obese patients undergoing AVR over full sternotomy. Suggesting that these approaches might be considered more beneficial alternatives for obese patients undergoing AVR.
Topics: Humans; Aortic Valve; Network Meta-Analysis; Heart Valve Prosthesis Implantation; Treatment Outcome; Minimally Invasive Surgical Procedures; Sternotomy; Obesity; Retrospective Studies
PubMed: 37559011
DOI: 10.1186/s12872-023-03410-9 -
Current Problems in Cardiology Jul 2024The ideal surgical intervention for secondary mitral regurgitation (SMR), a disease of the left ventricle not the mitral valve itself, is still debated. We performed an... (Meta-Analysis)
Meta-Analysis Comparative Study Review
Long-term outcomes comparison of mitral valve repair or replacement for secondary mitral valve regurgitation. An updated systematic review and reconstructed time-to-event study-level meta-analysis.
BACKGROUND AND AIM
The ideal surgical intervention for secondary mitral regurgitation (SMR), a disease of the left ventricle not the mitral valve itself, is still debated. We performed an updated systematic review and study-level meta-analysis investigating mitral valve repair (MVr) versus mitral valve replacement (MVR) for adult patients with SMR, with or without coronary artery disease (CAD).
METHODS
PubMed, CENTRAL and EMBASE were searched for studies comparing MVr versus MVR. Randomized trial or observational studies were considered eligible. Primary endpoint was long-term mortality for any cause. Kaplan-Meier survival curves were reconstructed and compared with Cox linear regression. Landmark analysis and time-varying hazard ratio (HR) were analyzed. Sensitivity analyses included meta-regression and separate sub-analysis. A random effects model was used.
RESULTS
Twenty-three studies (MVr=3,727 and MVR=2,839) were included. One study was a randomized trial, and 19 studies were adjusted. The mean weighted follow-up was 3.7±2.8 years. MVR was associated with significative greater late mortality (HR=1.26; 95 % CI, 1.14-1.39; P<0.0001) at 10-year follow-up. There was a time-varying trend showing an increased risk of mortality in the first 2 years after MVR (HR=1.38; 95 % CI, 1.21-1.56; P<0.0001), after which this difference dissipated (HR=0.94; 95 % CI, 0.81-1.09; P=0.41). Separate sub-analyses showed comparable long-term mortality in patients with concomitant coronary surgery ≥90 %, left ventricle ejection fraction ≤40 %, and sub-valvular apparatus preservation rate of 100 %.
CONCLUSIONS
Compared to repair, MVR is associated with higher probability of mortality in the first 2 years following surgery, after which the two procedures showed comparable late mortality rate.
Topics: Humans; Mitral Valve Insufficiency; Heart Valve Prosthesis Implantation; Mitral Valve; Treatment Outcome; Mitral Valve Annuloplasty; Time Factors
PubMed: 38735348
DOI: 10.1016/j.cpcardiol.2024.102636