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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 -
Journal of Cardiothoracic Surgery Jan 2023The effect of gender on patients with mitral valve regurgitation (MR) undergoing transcatheter mitral valve repair (TMVR) remains to be defined. The aim of the present... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The effect of gender on patients with mitral valve regurgitation (MR) undergoing transcatheter mitral valve repair (TMVR) remains to be defined. The aim of the present study is a comprehensive meta-analysis of studies that investigate differences between men and women after TMVR.
METHODS
A systematic literature search was carried out on eight databases to collect all relevant studies on gender-related outcomes of TMVR before March 1, 2021. The main outcomes of interest were mortality, cardiac function, MR class and other complications.
RESULTS
A total of eight literatures were included, all of which were retrospective observational studies. Compared to women patients, men had lower postoperative New York Heart Association (NYHA) class (OR = 1.53, 95%CI [1.23, 1.91], P = 0.0001) and higher incidence of postoperative acute kidney injury (AKI) (OR = 1.25, 95%CI [1.16, 1.34], P < 0.05). There were no significant difference on mortality in 30 days (OR = 0.95, 95%CI [0.81, 1.11], P = 0.53) and in 2 years (OR = 0.99, 95%CI [0.75, 1.30], P = 0.93), mitral valve regurgitation (MR) class (OR = 1.30, 95%CI [0.97, 1.75], P = 0.08) and incidence of myocardial infarction (MI) (OR = 0.88, 95%CI [0.65, 1.18], P = 0.38), stroke (OR = 0.80, 95%CI [0.63, 1.02], P = 0.08) and bleeding in hospital (OR = 0.84, 95%CI [0.59, 1.19], P = 0.32).
CONCLUSIONS
Our meta-analysis demonstrates that men undergoing TMVR have worse preoperative diseases (diabetes mellitus, coronary artery disease, renal failure and myocardial infarction) while they have superior postoperative NYHA class at one-year. There are no significantly difference in other indexes between men and women.
Topics: Male; Humans; Female; Mitral Valve Insufficiency; Mitral Valve; Treatment Outcome; Heart Valve Prosthesis Implantation; Retrospective Studies; Cardiac Catheterization; Myocardial Infarction
PubMed: 36650548
DOI: 10.1186/s13019-023-02123-6 -
Journal of Cardiothoracic Surgery Jun 2020The current treatment for aortic stenosis includes open surgical aortic valve replacement (SAVR) as well as endovascular transcatheter aortic valve replacement (TAVR).... (Comparative Study)
Comparative Study Meta-Analysis
Structural durability of early-generation Transcatheter aortic valve replacement valves compared with surgical aortic valve replacement valves in heart valve surgery: a systematic review and meta-analysis.
BACKGROUND
The current treatment for aortic stenosis includes open surgical aortic valve replacement (SAVR) as well as endovascular transcatheter aortic valve replacement (TAVR). This study aims to compare the 1-year, 2-3 year and 5-year structural durability of TAVR valves with that of SAVR valves.
METHOD
A systematic literature search was conducted in July 2019 on Medline (via PubMed), Embase and Cochrane electronic databases according to the PRISMA guidelines.
RESULTS
Thirteen randomized controlled trials were included. From the meta-analysis, we observed higher rates of 1-year (OR: 7.65, CI: 4.57 to 12.79, p < 0.00001), 2-3-year (OR: 13.49, CI: 5.66 to 32.16, p < 0.00001) and 5-year paravalvular regurgitation (OR: 14.51, CI: 4.47 to 47.09, p < 0.00001) associated with the TAVR valves than the SAVR valves. There were also higher rates of 1-year (OR: 5.00, CI: 3.27 to 7.67, p < 0.00001), 2-3-year (OR: 8.14, CI: 3.58 to 18.50, p < 0.00001) and 5-year moderate or severe aortic regurgitation (MD: 14.65, CI: 4.55 to 47.19, p < 0.00001), and higher rates of 1-year (OR: 3.55, CI: 1.86 to 6.77, p = 0.0001), 2-3-year (OR: 3.55, CI: 1.86 to 6.77, p = 0.0001) and 5-year reintervention (OR: 3.55, CI: 1.22 to 10.38, p = 0.02) in the TAVR valves as compared to SAVR valves.
CONCLUSION
TAVR valves appear to be more susceptible to structural valve deterioration and thus potentially less structurally durable than SAVR valves, given that they may be associated with higher rates of moderate or severe aortic regurgitation, paravalvular regurgitation and reintervention in the 1-year-, 2-3 year, and 5-year period.
Topics: Aortic Valve; Aortic Valve Insufficiency; Aortic Valve Stenosis; Fluoroscopy; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Randomized Controlled Trials as Topic; Risk Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 32513222
DOI: 10.1186/s13019-020-01170-7 -
Current Cardiology Reviews 2023The development of atrioventricular bioprosthesis has witnessed an increasing drive toward clinical translation over the last few decades. A significant challenge in the...
BACKGROUND
The development of atrioventricular bioprosthesis has witnessed an increasing drive toward clinical translation over the last few decades. A significant challenge in the clinical translation of an atrioventricular bioprosthesis from bench to bedside is the appropriate choice of a large animal model to test the safety and effectiveness of the device.
METHODS
We conducted a systematic review of pre-clinical in vivo studies that would enable us to synthesize a recommended framework. PRISMA (Preferred Reporting Items for Systematic Reviews and MetaAnalyses) guidelines were followed to identify and extract relevant articles.
RESULTS
Sheep was the most common choice of animal, with nine out of the 12 included studies being conducted on sheep. There were acute and chronic studies based on our search criteria. An average of ~20 and 5 animals were used for chronic and acute studies. One out of three acute studies and eight out of nine chronic studies were on stented heart valve bioprosthesis. All analyses were conducted on the implantation of atrioventricular valves with trileaflet, except for one chronic study on unileaflet valves and one chronic and acute study on bileaflet valves.
CONCLUSION
Understanding the variance in past pre-clinical study designs may increase the appropriate utilization of large animal models. This synthesized evidence provides a pre-clinical in vivo studies framework for future research on an atrioventricular bioprosthesis.
Topics: Humans; Animals; Sheep; Heart Valve Prosthesis Implantation; Mitral Valve; Prosthesis Design; Heart Valve Prosthesis; Bioprosthesis
PubMed: 35718960
DOI: 10.2174/1573403X18666220617115216 -
Journal of the American Heart... Apr 2021Mitral annular calcification with mitral valve disease is a challenging problem that could necessitate surgical mitral valve replacement (SMVR). Transcatheter mitral...
Mitral annular calcification with mitral valve disease is a challenging problem that could necessitate surgical mitral valve replacement (SMVR). Transcatheter mitral valve replacement (TMVR) is emerging as a feasible alternative in high-risk patients with appropriate anatomy. PubMed, Embase, and Cochrane Central Register of Controlled Trials were searched from inception to December 25, 2019 for studies discussing SMVR or TMVR in patients with mitral annular calcification; 27 of 1539 articles were selected for final review. TMVR was used in 15 studies. Relevant data were available on 82 patients who underwent hybrid transatrial TMVR, and 354 patients who underwent transapical or transseptal TMVR. Outcomes on SMVR were generally reported as small case series (447 patients from 11 studies); however, 1 large study recently reported outcomes in 9551 patients. Patients who underwent TMVR had a shorter median follow-up of 9 to 12 months (range, in-hospital‒19 months) compared with patients with SMVR (54 months; range, in-hospital‒120 months). Overall, those undergoing TMVR were older and had higher Society of Thoracic Surgeons risk scores. SMVR showed a wide range of early (0%-27%; median 6.3%) and long-term mortality (0%-65%; median at 1 year, 15.8%; 5 years, 38.8%, 10 years, 62.4%). The median in-hospital, 30-day, and 1-year mortality rates were 16.7%, 22.7%, and 43%, respectively, for transseptal/transapical TMVR, and 9.5%, 20.0%, and 40%, respectively, for transatrial TMVR. Mitral annular calcification is a complex disease and TMVR, with a versatile option of transatrial approach in patients with challenging anatomy, offers a promising alternative to SMVR in high-risk patients. However, further studies are needed to improve technology, patient selection, operative expertise, and long-term outcomes.
Topics: Aged; Calcinosis; Cardiac Catheterization; Heart Valve Diseases; Heart Valve Prosthesis Implantation; Humans; Mitral Valve; Postoperative Complications; Treatment Outcome
PubMed: 33728929
DOI: 10.1161/JAHA.120.018514 -
Journal of Clinical Medicine Jan 2023Objective. Valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) has emerged as a useful alternative intervention to redo-surgical aortic valve replacement... (Review)
Review
Objective. Valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) has emerged as a useful alternative intervention to redo-surgical aortic valve replacement (Redo-SVAR) for the treatment of degenerated bioprosthesis valve. However, there is no robust evidence about the long-term outcome of both treatments. The aim of this meta-analysis was to analyze the long-term outcomes of Redo-SVAR versus ViV-TAVI by reconstructing the time-to-event data. Methods. The search strategy consisted of a comprehensive review of relevant studies published between 1 January 2000 and 30 September 2022 in three electronic databases, PubMed, Cochrane Central Register of Controlled Trials (CENTRAL) and EMBASE. Relevant studies were retrieved for the analysis. The primary endpoint was the long-term mortality for all death. The comparisons were made by the Cox regression model and by landmark analysis and a fully parametric model. A random-effect method was applied to perform the meta-analysis. Results. Twelve studies fulfilled the eligibility criteria and were included in the final analysis. A total of 3547 patients were included. Redo-SAVR group included 1783 patients, and ViV-TAVI included 1764 subjects. Redo-SAVR showed a higher incidence of all-cause mortality within 30-days [Hazard ratio (HR) 2.12; 95% CI = 1.49−3.03; p < 0.0001)], whereas no difference was observed between 30 days and 1 year (HR = 1.03; 95% CI = 0.78−1.33; p = 0.92). From one year, Redo-SAVR showed a longer benefit (HR = 0.52; 95% CI = 0.40−0.67; p < 0.0001). These results were confirmed for cardiovascular death (HR = 2.04; 95% CI = 1.29−3.22; p = 0.001 within one month from intervention; HR = 0.35; 95% CI = 0.18−0.71; p = 0.003 at 4-years follow-up). Conclusions. Although the long-term outcomes seem similar between Redo-SAVR and ViV-TAVI at a five-year follow-up, ViV-TAVI shows significative lower mortality within 30 days. This advantage disappeared between 30 days and 1 year and reversed in favor of redo-SAVR 1 year after the intervention.
PubMed: 36675469
DOI: 10.3390/jcm12020541 -
Journal of the American Heart... Mar 2021Background During the past decade, the use of transcatheter aortic valve replacement (TAVR) was extended beyond treatment-naïve patients and implemented for treatment... (Meta-Analysis)
Meta-Analysis
Background During the past decade, the use of transcatheter aortic valve replacement (TAVR) was extended beyond treatment-naïve patients and implemented for treatment of degenerated surgical bioprosthetic valves. Selection criteria for either valve-in-valve (viv) TAVR or redo surgical aortic valve replacement are not well established, and decision making on the operative approach still remains challenging for the interdisciplinary heart team. Methods and Results This review was intended to analyze all studies on viv-TAVR focusing on short- and mid-term stroke and mortality rates compared with redo surgical aortic valve replacement or native TAVR procedures. A structured literature search and review process led to 1667 potentially relevant studies on July 1, 2020. Finally, 23 studies fulfilled the inclusion criteria for qualitative analysis. All references were case series either with or without propensity score matching and registry analyses. Quantitative synthesis of data from 8509 patients revealed that viv-TAVR is associated with mean 30-day stroke and mortality rates of 2.2% and 4.2%, respectively. Pooled data analysis showed no significant differences in 30-day stroke rate, 30-day mortality, and 1-year mortality between viv-TAVR and comparator treatment (native TAVR [n=11 804 patients] or redo surgical aortic valve replacement [n=498 patients]). Conclusions This review is the first one comparing the risk for stroke and mortality rates in viv-TAVR procedures with native TAVR approach and contributes substantial data for the clinical routine. Moreover, this systematic review is the most comprehensive analysis on ischemic cerebrovascular events and early mortality in patients undergoing viv-TAVR. In this era with increasing numbers of bioprosthetic valves used in younger patients, viv-TAVR is a suitable option for the treatment of degenerated bioprostheses.
Topics: Aortic Valve; Aortic Valve Stenosis; Global Health; Humans; Incidence; Prosthesis Design; Registries; Risk Factors; Stroke; Survival Rate; Transcatheter Aortic Valve Replacement
PubMed: 33682426
DOI: 10.1161/JAHA.120.019512 -
Journal of Cardiothoracic Surgery Jun 2021Mitral regurgitation (MR) is a rather common valvular heart disease. The aim of this systematic review and meta-analysis was to compare the outcomes, and complications... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Mitral regurgitation (MR) is a rather common valvular heart disease. The aim of this systematic review and meta-analysis was to compare the outcomes, and complications of mitral valve (MV) replacement with surgical MV repair of non-ischemic MR (NIMR) METHODS: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched until October, 2020. Studies were eligible for inclusion if they included patients with MR and reported early (30-day or in-hospital) or late all-cause mortality. For each study, data on all-cause mortality and incidence of reoperation and operative complications in both groups were used to generate odds ratios (ORs) or hazard ratios (HRs). This study is registered with PROSPERO, CRD42018089608.
RESULTS
The literature search yielded 4834 studies, of which 20 studies, including a total of 21,898 patients with NIMR, were included. The pooled analysis showed that lower age, less female inclusion and incident of hypertension, significantly higher rates of diabetes and atrial fibrillation in the MV replacement group than MV repair group. No significant differences in the rates of pre-operative left ventricle ejection fraction (LVEF) and heart failure were observed between groups. The number of patients in the MV repair group was lower than in the MV replacement group. We found that there were significantly increased risks of mortality associated with replacement of MR. Moreover, the rate of re-operation and post-operative MR in the MV repair group was lower than in the MV replacement group.
CONCLUSIONS
In patients with NIMR, MV repair achieves higher survival and leads to fewer complications than surgical MV replacement. In light of these results, we suggest that MV repair surgery should be a priority for NIMR patients.
Topics: Aged; Cardiac Surgical Procedures; Female; Heart Valve Prosthesis Implantation; Humans; Male; Middle Aged; Mitral Valve; Mitral Valve Insufficiency; Odds Ratio; Postoperative Complications; Proportional Hazards Models; Publication Bias; Reoperation; Stroke Volume; Treatment Outcome
PubMed: 34130728
DOI: 10.1186/s13019-021-01563-2 -
JACC. Cardiovascular Imaging Dec 2013This systematic review seeks to present the outcomes of the natural history of aortopathy associated with bicuspid aortic valve (ABAV) and after interventions. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
This systematic review seeks to present the outcomes of the natural history of aortopathy associated with bicuspid aortic valve (ABAV) and after interventions.
BACKGROUND
Aortopathy is common in patients with ABAV, and early intervention has been proposed to reduce the risk of dissection. In asymptomatic patients, the timing of surgical management is based upon imaging of aortic size, but the actual threshold is based upon observational data and expert opinion. As evidence of high risk would justify early intervention, we sought to define the natural history of this condition and after interventions.
METHODS
We undertook a systemic review of the evidence from observational studies of ABAV published up to June 2013. The primary outcome was annualized all-cause mortality. Secondary outcomes included acute aortic events, rates of aneurysm enlargement, and peri-operative complications. A random-effects model was used to combine outcomes. A meta-regression was undertaken to assess the impact of potential covariates.
RESULTS
The 32 eligible papers involved 11,045 patients (9,441 BAV and 1,604 control subjects, age 46 ± 14 years). There were 3 major groups, nonoperated bicuspid aortic valve (BAV) patients (ages from 30 to 40 years), patients after aortic surgery (generally 40 to 60 years of age) and after isolated valve replacement (>60 years of age). The respective annualized mortality of nonoperated BAV patients was 0.56% (95% confidence interval [CI]: 0.13 to 0.99), compared with 0.78% (95% CI: 0.20 to 1.36) in patients after aortic surgery and 2.39% (95% CI: 1.61 to 3.16) after isolated valve replacement. The annualized acute event rate in nonoperated BAV patients was 0.29% (95% CI: 0.23 to 0.35), this risk being no different from that of a tricuspid aortic valve (risk ratio: 0.68, 95% CI: 0.34 to 1.36). In the post-surgical series, 30-day mortality varied from 0% to 2.5%, and the risk of acute events was 0.16% (95% CI: 0.0 to 0.32) in patients after aortic surgery and 0.68% (95% CI: 0.42 to 0.94) after isolated valve replacement. Aortic dilation was at a rate of 0.16 mm/year over 6 decades in healthy BAV subjects and 1.1 ± 0.15 mm/year in older aortic valve replacement patients.
CONCLUSIONS
The risk associated with ABAV varies according to age and clinical setting. Nonetheless, despite aortic dilatation, the acute aortic event risk of ABAV appears low in current practice. Decision-making regarding the timing of intervention needs to be made on the basis of the balance between this low risk and both the morbidity and mortality of surgery.
Topics: Aorta; Aortic Aneurysm; Aortic Valve; Bicuspid Aortic Valve Disease; Dilatation, Pathologic; Disease Progression; Heart Valve Diseases; Heart Valve Prosthesis Implantation; Humans; Patient Selection; Risk Factors; Time Factors; Treatment Outcome; Vascular Surgical Procedures
PubMed: 24332283
DOI: 10.1016/j.jcmg.2013.10.005 -
Journal of Cardiothoracic Surgery Oct 2020The optimal treatment strategy following a failed mitral valve repair remains unclear. This study aims to compare and analyse available studies which report the clinical... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The optimal treatment strategy following a failed mitral valve repair remains unclear. This study aims to compare and analyse available studies which report the clinical outcomes post mitral valve re-repair (MVr) or replacement (MVR) after a prior mitral valve repair.
METHODS
Based on PRISMA guidelines, a literature search was performed utilising PubMed, Cochrane and Scopus databases to identify retrospective cohort studies that reported outcomes of MVr and MVR after a prior mitral valve repair. Data regarding operative mortality, clinical outcomes and complications were extracted, synthesized and meta-analysed where appropriate.
RESULTS
Eight studies with a total cohort of 1632 patients were used. After analysis, no significant differences in the short term and long-term operative mortality, incidence of stroke, congestive heart failure, Grade 1 and Grade 2 mitral regurgitation, requirement of 3rd mitral valve operation and reoperation due bleeding were found between the two groups. However, a slightly higher incidence of postoperative atrial fibrillation (OR: 0.11, CI: 0.02 to 0.17, I = 0%, p = 0.02) was observed in the MVR group, as compared to the MVr group.
CONCLUSION
MVr appears to be a viable alternative to MVR for mitral valve reoperation, given that they are associated with similar post-operative outcomes.
Topics: Bioprosthesis; Cardiac Surgical Procedures; Heart Failure; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Mitral Valve; Mitral Valve Insufficiency; Reoperation; Replantation; Retrospective Studies; Treatment Outcome
PubMed: 33028386
DOI: 10.1186/s13019-020-01344-3