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Heart Failure Reviews Jan 2024As the survival after heart transplantation (HTx) is steadily improving, an increasing number of patients with late cardiac pathologies such as valvular disease is... (Review)
Review
As the survival after heart transplantation (HTx) is steadily improving, an increasing number of patients with late cardiac pathologies such as valvular disease is expected to rise. Nevertheless, no guidelines for indication of redo cardiac surgery after HTx exists. The aim of the present systematic review is to describe the results reported in the literature of surgical management of severe aortic and/or mitral valve disease. A systematic review was conducted including studies reporting on adult patients with severe mitral or aortic valve pathology needing surgery after their previous HTx. Exclusion criteria consisted in surgery with no left heart valve surgery, concomitant valve surgery during heart transplant, transcatheter interventions, and heterotopic HTx. A total of 35 papers met our inclusion criteria out of 2755 potentially eligible studies with 44 mitral valve surgery patients and 20 aortic valve surgery patients. In the entire population, the mean time from HTx to reintervention was 6.19 ± 5.22 years. After a mean follow-up of 2.78 ± 3.54 years and 1.53 ± 2.26 years from reintervention, 65.6% mitral and 86.7% aortic patients were reported as alive, respectively. As guidelines on cardiac surgery after HTx are currently lacking, left-sided valvular cardiac reinterventions can be considered a possible therapeutic approach in carefully selected patients. These interventions may not only improve the patient's functional status and survival, but may ultimately reduce the need for re-transplantation due to the chronic shortage of donor hearts. However, the support of more robust data is warranted.
Topics: Adult; Humans; Heart Transplantation; Treatment Outcome; Tissue Donors; Heart Valve Diseases; Mitral Valve; Heart Diseases; Heart Valve Prosthesis Implantation
PubMed: 37950833
DOI: 10.1007/s10741-023-10368-5 -
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 -
Journal of the American Heart... Sep 2015Transcatheter aortic valve replacement (TAVR) is an effective alternative to surgical aortic valve replacement in patients at high surgical risk. However, there is... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Transcatheter aortic valve replacement (TAVR) is an effective alternative to surgical aortic valve replacement in patients at high surgical risk. However, there is little published literature on the exact causes of death.
METHODS AND RESULTS
The PubMed database was systematically searched for studies reporting causes of death within and after 30 days following TAVR. Twenty-eight studies out of 3934 results retrieved were identified. In the overall analysis, 46.4% and 51.6% of deaths were related to noncardiovascular causes within and after the first 30 days, respectively. Within 30 days of TAVR, infection/sepsis (18.5%), heart failure (14.7%), and multiorgan failure (13.2%) were the top 3 causes of death. Beyond 30 days, infection/sepsis (14.3%), heart failure (14.1%), and sudden death (10.8%) were the most common causes. All possible subgroup analyses were made. No significant differences were seen for proportions of cardiovascular deaths except the comparison between moderate (mean STS score 4 to 8) and high (mean STS score >8) -risk patients after 30 days post-TAVR (56.0% versus 33.5%, P=0.005).
CONCLUSIONS
Cardiovascular and noncardiovascular causes of death are evenly balanced both in the perioperative period and at long-term follow-up after TAVR. Infection/sepsis and heart failure were the most frequent noncardiovascular and cardiovascular causes of death. This study highlights important areas of clinical focus that could further improve outcomes after TAVR.
Topics: Aortic Valve Stenosis; Cardiac Catheterization; Cause of Death; Chi-Square Distribution; Death, Sudden; Heart Failure; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Multiple Organ Failure; Prosthesis Design; Risk Assessment; Risk Factors; Sepsis; Time Factors; Treatment Outcome
PubMed: 26391132
DOI: 10.1161/JAHA.115.002096 -
Journal of Cardiac Surgery Sep 2022Valvular heart disease (VHD) is a prominent problem in healthcare today with mitral regurgitation (MR) being the leading cause of VHD in the elderly population. While... (Review)
Review
BACKGROUND
Valvular heart disease (VHD) is a prominent problem in healthcare today with mitral regurgitation (MR) being the leading cause of VHD in the elderly population. While mitral valve repair (MVr) surgery is one of the only options for the end-stage disease, octogenarians are often denied MVr due to concerns with operative mortality and postoperative morbidity. To provide information on this underrepresented group of surgical patients, a systematic approach was taken to review the mortality and morbidity rates of octogenarians who received MVr.
METHODS
Pubmed and Medline were searched for articles containing outcomes of octogenarians receiving surgical mitral valve repair (SMVr) or transcatheter mitral valve repair (TMVr) published after 2000. Ten articles met the inclusion criteria for a total of 7968 patients included in the analysis using Microsoft Excel, Version 2105.
RESULTS
Short-term mortality rates for SMVr and TMVr were 2.6% and 1.4% for in-hospital, and 7.8% and 3.3% for 30 days, respectively. The average incidence of stroke, acute kidney injury, infection, and major bleeding for SMVr were 3.2%, 11.2%, 7.7%, and 24%, respectively, and 0.3%, 6.7%, 2.7%, and 7.9% for TMVr, respectively.
CONCLUSION
Octogenarians receiving SMVr or TMVr experienced similar rates of short-term mortality and morbidity as younger populations, and when considering life expectancy, midterm mortality was also similar. With these results, denying octogenarians MVr operations based on age alone should be reconsidered. Depending on risk factors and comorbidities, either SMVr or TMVr is a viable and relatively safe option for octogenarians with severe MR.
Topics: Aged; Aged, 80 and over; Cardiac Catheterization; Heart Valve Diseases; Heart Valve Prosthesis Implantation; Humans; Mitral Valve; Mitral Valve Insufficiency; Morbidity; Octogenarians; Treatment Outcome
PubMed: 35652892
DOI: 10.1111/jocs.16653 -
Heart (British Cardiac Society) Dec 2011There is little evidence guiding heart valve prosthesis selection in patients with end-stage renal disease (ESRD) on dialysis. (Meta-Analysis)
Meta-Analysis Review
CONTEXT
There is little evidence guiding heart valve prosthesis selection in patients with end-stage renal disease (ESRD) on dialysis.
OBJECTIVES
To perform: 1) a systematic review of studies examining valve replacement in patients with ESRD on dialysis; and 2) a quantitative meta-analysis comparing survival and valve-related outcomes following valve replacement with bioprostheses versus mechanical prostheses in this population.
DATA SOURCES
English studies published from 1990 onwards.
STUDY SELECTION
Studies were included in the meta-analysis if they compared bioprostheses with mechanical prostheses in patients with ESRD on dialysis.
DATA EXTRACTION
Extracted summary estimates included the hazard ratio (HR) for death, and the odds ratio (OR) for developing valve-related complications due to the use of bioprostheses versus mechanical prosthesis.
RESULTS
Twelve studies published from 1997 to 2010 were included in this review, of which 9 were used in the meta-analysis. No evidence of publication bias was detected. The aortic valve was the most common valve replaced in these studies (4339/6350), although 11 of the 12 studies also included mitral or multiple valve replacements. No difference in survival was observed between valve types (bioprostheses versus mechanical prostheses hazard ratio 1.3, 95% confidence interval (CI) 1.0-1.9, p = 0.09). However, valve replacement with bioprostheses was associated with fewer valve-related complications compared to mechanical prostheses (odds ratio 0.4, 95% CI 0.2-0.7, p = 0.002).
CONCLUSIONS
A meta-analysis of the published literature demonstrates no survival difference following valve replacement with either bioprostheses or mechanical prosthesis in patients with ESRD on dialysis. Bioprosthetic valve replacement was associated with fewer valve-related complications. Although this meta-analysis cannot discriminate between the sites of valve implant, these data can likely be extended to include at least aortic valve replacement.
Topics: Bioprosthesis; Heart Valve Diseases; Heart Valve Prosthesis; Humans; Kidney Failure, Chronic; Prognosis; Prosthesis Design; Renal Dialysis; Survival Rate
PubMed: 21990382
DOI: 10.1136/heartjnl-2011-300727 -
The Annals of Thoracic Surgery Jul 2016The choice of a bioprosthetic valve (BV) or mechanical valve (MV) in middle-aged adults undergoing aortic valve replacement is a complex decision that must account for... (Meta-Analysis)
Meta-Analysis Review
The choice of a bioprosthetic valve (BV) or mechanical valve (MV) in middle-aged adults undergoing aortic valve replacement is a complex decision that must account for numerous prosthesis and patient factors. A systematic review and meta-analysis was performed to compare long-term survival, major adverse prosthesis-related events, anticoagulant-related events, major bleeding, reoperation, and structural valve degeneration in middle-aged patients receiving a BV or MV. A comprehensive search from six electronic databases was performed from their inception to February 2016. Results from patients aged less than 70 years undergoing aortic valve replacement with a BV or MV were included. There were 12 studies involving 8,661 patients. Baseline characteristics were similar. There was no significant difference in long-term survival among patients aged 50 to 70 or 60 to 70 years. Compared with MVs, BVs had significantly fewer long-term anticoagulant-related events (hazard ratio [HR] 0.54, p = 0.006) and bleeding (HR 0.48, p < 0.00001) but significantly greater major adverse prosthesis-related events (HR 1.82, p = 0.02), including reoperation (HR 2.19, p < 0.00001). The present meta-analysis found no significant difference in survival between BVs and MVs in patients aged 50 to 70 or 60 to 70 years. Compared with MVs, BVs have reduced risk of major bleeding and anticoagulant-related events but increased risk of structural valve degeneration and reoperation. However, the mortality consequences of reoperation appear lower than that of major bleeding, and recent advances may further lower the reoperation rate for BV. Therefore, this review supports the current trend of using BVs in patients more than 60 years of age.
Topics: Aortic Valve; Bioprosthesis; Heart Valve Diseases; Heart Valve Prosthesis Implantation; Humans; Middle Aged; Prosthesis Design
PubMed: 26794881
DOI: 10.1016/j.athoracsur.2015.10.092 -
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 -
Cardiovascular Revascularization... Sep 2022
Meta-Analysis
Commentary on the Prognostic Impact of Pre- and Post-Procedural Renal Dysfunction on Late All-Cause Mortality Outcome Following Transcatheter Edge-to-Edge Repair of the Mitral Valve: A Systematic Review and Meta-Analysis.
Topics: Heart Valve Prosthesis Implantation; Humans; Kidney Diseases; Mitral Valve; Mitral Valve Insufficiency; Prognosis
PubMed: 35811241
DOI: 10.1016/j.carrev.2022.04.022 -
Scandinavian Journal of Surgery : SJS :... Dec 2022The published literature investigating the impact of sex on outcomes after mitral valve (MV) surgery has demonstrated inferior outcomes for females over males. However,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND OBJECTIVE
The published literature investigating the impact of sex on outcomes after mitral valve (MV) surgery has demonstrated inferior outcomes for females over males. However, the true relationship between sex and outcomes after MV surgery continues to be poorly understood.
MATERIALS
PubMed, Medline, and Embase were systematically searched for articles published from 1 January 2005 to 1 August 2021. This systematic review included retrospective and prospective studies investigating the relationship between sex and outcomes after MV surgery. In all, 2068 articles were initially screened and 12 studies were included in this review.
RESULTS
Few studies were adequately powered or structured to investigate this topic. Few studies propensity matched patients or isolated for surgical approach. In individual studies, females experienced increased rates of short-term and long-term mortality and increased 1-year mortality in the pooled data. Males experienced increased rates of required pacemaker insertion. The remaining rates of morbidity and mortality did not differ significantly between males and females.
CONCLUSIONS
This review identified increased rates of 1-year mortality in the pooled data for females, while males had increased rates of pacemaker insertion. Despite this, the absence of propensity matching and isolating for surgical approach has introduced confounding variables that impair the ability of the included studies to interpret the results found in the current literature. Studies isolating for surgical approach, propensity matching patients, and examining outcomes with long-term follow-up are required to elucidate the true nature of this relationship.
Topics: Male; Female; Humans; Mitral Valve; Heart Valve Prosthesis Implantation; Retrospective Studies; Prospective Studies; Cardiac Surgical Procedures; Treatment Outcome
PubMed: 36112913
DOI: 10.1177/14574969221124468 -
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