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BMJ Open Apr 2018The importance of Cardiac Implant Registry (CIR) for ensuring a long-term follow-up in postmarket surveillance has been recognised and approved, but there is lack of... (Review)
Review
OBJECTIVES
The importance of Cardiac Implant Registry (CIR) for ensuring a long-term follow-up in postmarket surveillance has been recognised and approved, but there is lack of consensus standards on how to establish a CIR. The aim of this study is to investigate the structure and key elements of CIRs in the past decade (2006-2016) and to provide recommendations on 'best practice' approaches.
SETTINGS AND PARTICIPANTS
A systematic search on CIR was employed in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The following databases were searched: the PubMed (Medline), ScienceDirect and the Scopus database, EMBASE. After identifying the existing CIRs, an aggregative approach will be used to explore key elements emerging in the identified registries.
RESULTS
The following 82 registries were identified: 18 implantable cardioverterdefibrillator (ICD) registries, 7 cardiac resynchronisation therapy (CRT) registries, 5 pacemaker registries and 6 cardiovascular implantable electronic device registries which combined ICD, pacemaker and CRT implantation data; as well as 22 coronary stent registries and 24 transcatheteraortic heart valve implantation registries. While 71 national or local registries are from a single country, 44 are from European countries and 9 are located in USA. The following criteria have been summarised from the identified registries, including: registry working group, ethic issues, transparency, research objective, inclusion criteria, compulsory participation, endpoint, sample size, data collection basement, data collection methods, data entry, data validation and statistical analysis.
CONCLUSIONS
Registries provide a 'real-world' picture for patients, physicians, manufacturers, payers, decision-makers and other stakeholders. CIRs are important for regulatory decisions concerning the safety and therefore approval issues of the medical device; for payers CIRs provide evidence on the medical device benefit and drive the decision whether the product should be reimbursed or not; for hospitals CIRs' data are important for sound procurement decisions, and CIRs also help patients and their physicians to joint decision-making which of the products is the most appropriate.
Topics: Cardiac Resynchronization Therapy; Coronary Disease; Defibrillators, Implantable; Europe; Heart Diseases; Heart Valve Prosthesis Implantation; Humans; Pacemaker, Artificial; Prostheses and Implants; Registries; Stents; United States
PubMed: 29654008
DOI: 10.1136/bmjopen-2017-019039 -
Journal of Cardiovascular Imaging Apr 2023Minimizing contrast dose and radiation exposure while maintaining image quality during computed tomography angiography (CTA) for transcatheter aortic valve replacement...
BACKGROUND
Minimizing contrast dose and radiation exposure while maintaining image quality during computed tomography angiography (CTA) for transcatheter aortic valve replacement (TAVR) is desirable, but not well established. This systematic review compares image quality for low contrast and low kV CTA versus conventional CTA in patients with aortic stenosis undergoing TAVR planning.
METHODS
We performed a systematic literature review to identify clinical studies comparing imaging strategies for patients with aortic stenosis undergoing TAVR planning. The primary outcomes of image quality as assessed by the signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) were reported as random effects mean difference with 95% confidence interval (CI).
RESULTS
We included 6 studies reporting on 353 patients. There was no difference in cardiac SNR (mean difference, -1.42; 95% CI, -5.71 to 2.88; p = 0.52), cardiac CNR (mean difference, -3.83; 95% CI, -9.98 to 2.32; p = 0.22), aortic SNR (mean difference, -0.23; 95% CI, -7.83 to 7.37; p = 0.95), aortic CNR (mean difference, -3.95; 95% CI, -12.03 to 4.13; p = 0.34), and ileofemoral SNR (mean difference, -6.09; 95% CI, -13.80 to 1.62; p = 0.12) between the low dose and conventional protocols. There was a difference in ileofemoral CNR between the low dose and conventional protocols with a mean difference of -9.26 (95% CI, -15.06 to -3.46; p = 0.002). Overall, subjective image quality was similar between the 2 protocols.
CONCLUSIONS
This systematic review suggests that low contrast and low kV CTA for TAVR planning provides similar image quality to conventional CTA.
PubMed: 37096677
DOI: 10.4250/jcvi.2022.0108 -
JACC. Cardiovascular Imaging Nov 2019This meta-analysis investigated the diagnostic values of transthoracic echocardiography (TTE), 2-dimensional (2D) and 3-dimensional (3D) transesophageal echocardiography... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
This meta-analysis investigated the diagnostic values of transthoracic echocardiography (TTE), 2-dimensional (2D) and 3-dimensional (3D) transesophageal echocardiography (TEE), and multidetector-row computed tomography (MDCT) in patients with suspected mechanical prosthetic valve obstruction (PVO) for detecting subprosthetic mass and differentiating its causes.
BACKGROUND
Diagnostic values of advanced imaging modalities, such as MDCT and TEE, for the detection and differentiation of PVO have not been investigated.
METHODS
PubMed and EMBASE were systematically searched for studies that evaluated PVO using imaging modalities. The modified Quality Assessment of Diagnostic Accuracy Studies-2 tool was used to evaluate study quality. Pooled sensitivity of each modality for PVO detection and pooled diagnostic accuracy of TEE and MDCT for differentiating the causes of PVO were analyzed. Study heterogeneity was also assessed.
RESULTS
Seventeen studies (229 patients) that used at least 1 index tool among TTE, TEE, or MDCT were included. For detecting a subprosthetic mass that caused PVO, 3D TEE and MDCT showed a higher sensitivity of 81% (95% confidence interval [CI]: 40% to 95%) and 88% (95% CI: 81% to 93%), respectively, compared with TTE (20%; 95% CI: 7% to 47%) and 2D TEE (68%; 95% CI: 46% to 84%). Pooled sensitivity and specificity for diagnosing thrombus as a cause of PVO was 75% (95% CI: 54% to 88%) and 75% (95% CI: 40% to 93%), respectively, for TEE and 45% (95% CI: 16% to 77%) and 90% (95% CI: 77% to 96%), respectively, for MDCT. Pooled sensitivity for diagnosing pannus as a cause of PVO was 62% (95% CI: 46% to 76%) for TEE and 85% (95% CI: 70% to 93%) for MDCT.
CONCLUSIONS
This meta-analysis suggested that MDCT and 3D TEE have higher sensitivity than do TTE and 2D TEE, and can be reliable imaging modalities for detecting a subprosthetic mass that causes PVO. Moreover, MDCT can more accurately differentiate the cause of PVO than does TEE.
Topics: Adult; Aged; Diagnosis, Differential; Echocardiography, Three-Dimensional; Echocardiography, Transesophageal; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Heart Valves; Humans; Male; Middle Aged; Multidetector Computed Tomography; Postoperative Complications; Predictive Value of Tests; Prosthesis Design; Prosthesis Failure; Reproducibility of Results; Risk Factors; Treatment Outcome
PubMed: 30772236
DOI: 10.1016/j.jcmg.2018.11.033 -
Heart Views : the Official Journal of... 2022Transcatheter aortic valve in valve (Aviv) replacement has been shown to be an effective therapeutic option in patients with failed aortic bioprosthetic valves. This... (Review)
Review
BACKGROUND
Transcatheter aortic valve in valve (Aviv) replacement has been shown to be an effective therapeutic option in patients with failed aortic bioprosthetic valves. This review intended to evaluate contemporary 1-year outcomes of Aviv in recent studies.
METHODS
A systematic review on outcomes of Aviv was performed using the best available evidence from studies obtained using a MEDLINE, Cochrane database, and SCOPUS search. Endpoints of interest were survival, coronary artery obstruction, prosthesis-patient mismatch (PPM), stroke, pacemaker implantation, and structural valve deterioration.
RESULTS
A total of 3339 patients from 23 studies were included. Mean age was 68-80 years, 20%-50% were female, and Society of Thoracic Surgeons score ranged from 5.7 to 31.1. Thirty-day all-cause mortality ranged from 2% to 8%, and 1-year all-cause mortality ranged from 8% to 33%. Coronary artery obstruction risk after Aviv ranged from 0.6% to 4%. One-year stroke ranged from 2% to 8%. Moderate-severe PPM occurred in 11%-58%, and pacemaker rate at 1 year ranged from 5% to 12%.
CONCLUSION
Transcatheter aortic ViV has emerged as an effective therapeutic option to treat patients with failed bioprostheses. The acceptable complication rate and favorable 1-year outcomes make Aviv an appropriate alternative to redo surgical aortic valve replacement.
PubMed: 35757448
DOI: 10.4103/heartviews.heartviews_25_22 -
Frontiers in Cardiovascular Medicine 2022We sought to conduct a systematic review and meta-analysis of clinical adverse events in patients undergoing transcatheter aortic valve replacement (TAVR) with bicuspid...
OBJECTIVE
We sought to conduct a systematic review and meta-analysis of clinical adverse events in patients undergoing transcatheter aortic valve replacement (TAVR) with bicuspid aortic valve (BAV) vs. tricuspid aortic valve (TAV) anatomy and the efficacy of balloon-expandable (BE) vs. self-expanding (SE) valves in the BAV population. Comparisons aforementioned will be made stratified into early- and new-generation devices. Differences of prosthetic geometry on CT between patients with BAV and TAV were presented. In addition, BAV morphological presentations in included studies were summarized.
METHOD
Observational studies and a randomized controlled trial of patients with BAV undergoing TAVR were included according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline.
RESULTS
A total of 43 studies were included in the final analysis. In patients undergoing TAVR, type 1 BAV was the most common phenotype and type 2 BAV accounted for the least. Significant higher risks of conversion to surgical aortic valve replacement (SAVR), the need of a second valve, a moderate or severe paravalvular leakage (PVL), device failure, acute kidney injury (AKI), and stroke were observed in patients with BAV than in patients with TAV during hospitalization. BAV had a higher risk of new permanent pacemaker implantation (PPI) both at hospitalization and a 30-day follow-up. Risk of 1-year mortality was significantly lower in patients with BAV than that with TAV [odds ratio (OR) = 0.85, 95% CI 0.75-0.97, = 0.01]. BE transcatheter heart valves (THVs) had higher risks of annular rupture but a lower risk of the need of a second valve and a new PPI than SE THVs. Moreover, BE THV was less expanded and more elliptical in BAV than in TAV. In general, the rates of clinical adverse events were lower in new-generation THVs than in early-generation THVs in both BAV and TAV.
CONCLUSIONS
Despite higher risks of conversion to SAVR, the need of a second valve, moderate or severe PVL, device failure, AKI, stroke, and new PPI, TAVR seems to be a viable option for selected patients with severe bicuspid aortic stenosis (AS), which demonstrated a potential benefit of 1-year survival, especially among lower surgical risk population using new-generation devices. Larger randomized studies are needed to guide patient selection and verified the durable performance of THVs in the BAV population.
PubMed: 35369357
DOI: 10.3389/fcvm.2022.794850 -
EuroIntervention : Journal of EuroPCR... Feb 2014To evaluate the outcomes of mitral valve surgery in octogenarians with severe symptomatic mitral regurgitation (MR). (Meta-Analysis)
Meta-Analysis Review
AIMS
To evaluate the outcomes of mitral valve surgery in octogenarians with severe symptomatic mitral regurgitation (MR).
METHODS AND RESULTS
We performed a systematic review and meta-analysis of data on octogenarians who underwent mitral valve replacement (MVR) or mitral valve repair (MVRpr). Our search yielded 16 retrospective studies. Using Bayesian hierarchical models, we estimated the pooled proportion of 30-day mortality, postoperative stroke, and long-term survival. The pooled proportion of 30-day postoperative mortality was 13% following MVR (10 studies, 3,105 patients, 95% credible interval [CI] 9-18%), and 7% following MVRpr (six studies, 2,642 patients, 95% CI: 3-12%). Furthermore, pooled proportions of postoperative stroke were 4% (six studies, 2,945 patients, 95% CI: 3-7%) and 3% (three studies, 348 patients, 95% CI: 1-8%) for patients undergoing MVR and MVRpr, respectively. Pooled survival rates at one and five years following MVR (four studies, 250 patients) were 67% (95% CI: 50-80%) and 29% (95% CI: 16-47%), and following MVRpr (three studies, 333 patients) were 69% (95% CI: 50-83%) and 23% (95% CI: 12-39%), respectively.
CONCLUSIONS
Surgical treatment of MR in octogenarians is associated with high perioperative mortality and poor long-term survival with an uncertain benefit on quality of life. These data highlight the importance of patient selection for operative intervention and suggest that future transcatheter mitral valve therapies such as transcatheter mitral valve repair (TMVr) and/or transcatheter mitral valve implantation (TMVI), may provide an alternative therapeutic approach in selected high-risk elderly patients.
Topics: Age Factors; Aged, 80 and over; Cardiac Catheterization; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Mitral Valve; Mitral Valve Insufficiency; Quality of Life; Risk Factors; Severity of Illness Index; Survival Rate; Time Factors; Treatment Outcome
PubMed: 24035898
DOI: 10.4244/EIJV9I10A205 -
International Journal of Environmental... Feb 2023Transcatheter aortic valve implantation (TAVI) has become a broadly acceptable alternative to AV surgery in patients with aortic stenosis (AS). New valve designs are... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Transcatheter aortic valve implantation (TAVI) has become a broadly acceptable alternative to AV surgery in patients with aortic stenosis (AS). New valve designs are becoming available to address the shortcomings of their predecessors and improve clinical outcomes.
METHODS
A systematic review and meta-analysis was carried out to compare Medtronic's Evolut PRO, a new valve, with the previous Evolut R design. Procedural, functional and clinical endpoints according to the VARC-2 criteria were assessed.
RESULTS
Eleven observational studies involving N = 12,363 patients were included. Evolut PRO patients differed regarding age ( < 0.001), sex ( < 0.001) and STS-PROM estimated risk. There was no difference between the two devices in terms of TAVI-related early complications and clinical endpoints. A 35% reduction of the risk of moderate-to-severe paravalvular leak (PVL) favoring the Evolut PRO was observed (RR 0.66, 95%CI, [0.52, 0.86] = 0.002; = 0%). Similarly, Evolut PRO-treated patients demonstrated a reduction of over 35% in the risk of serious bleeding as compared with the Evolut R (RR 0.63, 95%CI, [0.41, 0.96]; = 0.03; = 39%), without differences in major vascular complications.
CONCLUSIONS
The evidence shows good short-term outcomes of both the Evolut PRO and Evolut R prostheses, with no differences in clinical and procedural endpoints. The Evolut PRO was associated with a lower rate of moderate-to-severe PVL and major bleeding.
Topics: Humans; Transcatheter Aortic Valve Replacement; Prosthesis Design; Postoperative Complications; Treatment Outcome; Aortic Valve Stenosis; Hemorrhage; Risk Factors
PubMed: 36834131
DOI: 10.3390/ijerph20043439 -
Aorta (Stamford, Conn.) Feb 2014Background : It is widely accepted that aortic valve disease is surgically managed with aortic valve replacement (AVR) using different available prostheses. The...
UNLABELLED
Background : It is widely accepted that aortic valve disease is surgically managed with aortic valve replacement (AVR) using different available prostheses. The long-term survival, durability of the valve, and freedom from reoperation after AVR are well established in published literature. Over the past two decades, aortic valve repair (AVr) has evolved into an accepted surgical option for patients with aortic valve disease. We review and analyze the published literature on AVr. Methods : A systematic review of the current literature was performed through three electronic databases from inception to August 2013 to identify all relevant studies relating to aortic valve repair. Articles selected were chosen by two reviewers. Articles were excluded if they contained a pediatric population or if the patient number was less than 50.
RESULTS
Twenty-four studies conformed to the inclusion criteria for inclusion in the systematic review. In total, 4986 patients underwent aortic valve repair. 7 studies represented bicuspid aortic valve (BAV) repair, 5 studies represented cusp prolapse, and 3 studies represented valve repair with root dilation or aneurysm. Overall weighted in-hospital mortality for all studies was low (1.46% ± 1.21). Preoperative aortic insufficiency (AI) ≥ 2+ did not correlate to reoperation for valve failure (Pearson's Rs 0.2705, P = 0.2585). AI at discharge was reported in 9 studies with a mean AI ≥ 2+ in 6.1% of patients. Weighted average percentage for valve reoperation following BAV repair was 10.23% ± 3.2. Weighted average reoperation following cusp prolapse repair was 3.83 ± 1.96. Weighted average reoperation in aortic valve sparing procedures with root replacement was 4.25% ± 2.46. Although there are limitations and complications of prosthetic valves, especially for younger individuals, there is ample published literature that confers strong evidence for AVR. On the contrary, aortic valve repair may be a useful option for selected patients, but there is lack of uniformity in data and absence of compelling supporting evidence. An international multi-center study comparing and assessing the results between AVR & AVr is the next step required. Currently, higher levels of evidence do not exist for aortic valve repair.
PubMed: 26798710
DOI: 10.12945/j.aorta.2014.14-003 -
JACC. Cardiovascular Interventions May 2013This study sought to evaluate, through a systematic review of the published data, the main baseline characteristics, management, and clinical outcomes of patients... (Review)
Review
OBJECTIVES
This study sought to evaluate, through a systematic review of the published data, the main baseline characteristics, management, and clinical outcomes of patients suffering coronary obstruction as a complication of transcatheter aortic valve implantation (TAVI).
BACKGROUND
Very few data exist on coronary obstruction after TAVI.
METHODS
Studies published between 2002 and 2012, with regard to coronary obstruction as a complication of TAVI, were identified with a systematic electronic search. Only the studies reporting data on the main baseline and procedural characteristics, management of the complication, and clinical outcomes were analyzed.
RESULTS
A total of 18 publications describing 24 patients were identified. Most (83%) patients were women, with a mean age of 83 ± 7 years and a mean logistic European System for Cardiac Operative Risk Evaluation score of 25.1 ± 12.0%. Mean left coronary artery (LCA) ostium height and aortic root width were 10.3 ± 1.6 mm and 27.8 ± 2.8 mm, respectively. Most patients (88%) had received a balloon-expandable valve, and coronary obstruction occurred more frequently in the LCA (88%). Percutaneous coronary intervention was attempted in 23 cases (95.8%) and was successful in all but 2 patients (91.3%). At 30-day follow-up, there were no cases of stent thrombosis or repeat revascularization, and the mortality rate was 8.3%.
CONCLUSIONS
Reported cases of coronary obstruction after TAVI occurred more frequently in women, in patients receiving a balloon-expandable valve, and the LCA was the most commonly involved artery. Percutaneous coronary intervention was a feasible and successful treatment in most cases. Continuous efforts should be made to identify the factors associated with this life-threatening complication to implement the appropriate measures for its prevention.
Topics: Aged; Aged, 80 and over; Aortic Valve Stenosis; Cardiac Catheterization; Chi-Square Distribution; Coronary Artery Disease; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Logistic Models; Male; Percutaneous Coronary Intervention; Prosthesis Design; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome
PubMed: 23602458
DOI: 10.1016/j.jcin.2012.11.014 -
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