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Journal of Osteopathic Medicine Jan 2021The Reporting Items for Practice Guidelines in Health Care (RIGHT) Statement was developed by a multidisciplinary team of experts to improve reporting quality and...
CONTEXT
The Reporting Items for Practice Guidelines in Health Care (RIGHT) Statement was developed by a multidisciplinary team of experts to improve reporting quality and transparency in clinical practice guideline development.
OBJECTIVE
To assess the quality of reporting in clinical practice guidelines put forth by the Society of Interventional Radiology (SIR) and their adherence to the RIGHT statement checklist.
METHODS
In March 2018, using the 22 criteria listed in the RIGHT statement, two researchers independently documented adherence to each item for all eligible guidelines listed by the SIR by reading through each guideline and using the RIGHT statement elaboration and explanation document as a guide to determine if each item was appropriately addressed as listed in the checklist. To qualify for inclusion in this study, each guideline must have met the strict definition for a clinical practice guideline as set forth by the National Institute of Health and the Institute of Medicine, meaning they were informed by a systematic review of evidence and intended to direct patient care and physician decisions. Guidelines were excluded if they were identified as consensus statements, position statements, reporting standards, and training standards or guidelines. After exclusion criteria were applied, the two researchers scored each of the remaining clinical practice guidelines (CPGs) using a prespecified abstraction Google form that reflected the RIGHT statement checklist (22 criteria; 35 items inclusive of subset questions). Each item on the abstraction form consisted of a "yes/no" option; each item on the RIGHT checklist was recorded as "yes" if it was included in the guideline and "no" if it was not. Each checklist item was weighed equally. Partial adherence to checklist items was recorded as "no." Data were extracted into Microsoft Excel (Microsoft Corporation) for statistical analysis.
RESULTS
The initial search results yielded 129 CPGs in the following areas: 13 of the guidelines were in the field of interventional oncology; 16 in neurovascular disorders; five in nonvascular interventions; four in pediatrics; 25 in peripheral, arterial, and aortic disease; one in cardiac; one in portal and mesenteric vascular disease; 37 in practice development and safety; three in spine and musculoskeletal disorders; 14 in venous disease; five in renal failure/hemodialysis; and five in women's health. Of the 46 guidelines deemed eligible for evaluation by the RIGHT checklist, 12 of the checklist items showed less than 25% adherence and 13 showed more than 75% adherence. Of 35 individual RIGHT statement checklist items, adherence was found for a mean (SD) of 22.9 items (16.3). The median number of items with adherence was 21 (interquartile range, 7.5-38).
CONCLUSION
The quality of reporting in interventional radiology guidelines is lacking in several key areas, including whether patient preferences were considered, whether costs and resources were considered, the strength of the recommendations, and the certainty of the body of evidence. Poor adherence to the RIGHT statement checklist in these guidelines reveals many areas for improvement in guideline reporting.
Topics: Checklist; Delivery of Health Care; Humans; Radiology, Interventional; Societies; United States
PubMed: 33512392
DOI: 10.1515/jom-2020-0024 -
Scientific Reports Oct 2022Sarcopenia is characterised by chronically reduced skeletal muscle volume and function, and is determined radiologically by psoas and skeletal muscle measurement. The... (Meta-Analysis)
Meta-Analysis
Sarcopenia is characterised by chronically reduced skeletal muscle volume and function, and is determined radiologically by psoas and skeletal muscle measurement. The present systematic review and meta-analysis aims to examine the relationship between pre-operative CT-derived psoas and skeletal muscle parameters and outcomes in patients undergoing EVAR and F/B-EVAR for aortic aneurysm. The MEDLINE database was interrogated for studies investigating the effect of pre-operative CT-diagnosed sarcopenia on outcomes following EVAR and F/B-EVAR. The systematic review was carried out in accordance with PRISMA guidelines. The primary outcome was overall mortality. RevMan 5.4.1 was used to perform meta-analysis. PROSPERO Database Registration Number: CRD42021273085. Ten relevant studies were identified, one reporting skeletal muscle parameters, and the remaining nine reporting psoas muscle parameters, which were used for meta-analysis. There were a total of 2563 patients included (2062 EVAR, 501 F/B-EVAR), with mean follow-up ranging from 25 to 101 months. 836 patients (33%) were defined as radiologically sarcopenic. In all studies, the combined HR for all-cause mortality in sarcopenic versus non-sarcopenic patients was 2.61 (1.67-4.08), p < .001. Two studies reported outcomes on patients undergoing F/B-EVAR; the combined HR for all-cause mortality in sarcopenic versus non-sarcopenic patients was 3.08 (1.66-5.71), p = .004. Radiological sarcopenia defined by psoas or skeletal muscle parameters was associated with inferior survival in patients undergoing both EVAR and F/B-EVAR. Current evidence is limited by heterogeneity in assessment of body composition and lack of a consensus definition of radiological sarcopenia.
Topics: Aortic Aneurysm, Abdominal; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Humans; Psoas Muscles; Risk Factors; Sarcopenia; Treatment Outcome
PubMed: 36198699
DOI: 10.1038/s41598-022-20490-3 -
Cardiovascular Ultrasound Dec 2019Left ventricular hypertrophy and diastolic dysfunction are common echocardiographic features of both aortic valve stenosis (AS) and cardiac amyloidosis (CA). These two...
BACKGROUND
Left ventricular hypertrophy and diastolic dysfunction are common echocardiographic features of both aortic valve stenosis (AS) and cardiac amyloidosis (CA). These two different entities therefore may mask each other. From recent years, there is a growing body of evidence about the relatively high incidence of wild-type transthyretin (wtTTR) amyloidosis in AS, but there are scarce data on the prevalence of AS in CA, particularly in AL-type amyloidosis. The echocardiographic approach to these patients is not obvious, and not evidence based. We aimed to study the prevalence, severity, and type of AS in patients with CA and also to evaluate the potential of echocardiography in the diagnostic process.
METHODS
Between January 2009 and January 2019, we retrospectively analyzed the clinical and echocardiographic data, and the echocardiographic work up of 55 consecutive CA patients.
RESULTS
80% of our CA patients had AL amyloidosis. We identified 5 patients (9%) with moderate to severe AS: two with moderate AS and three with low-flow, low-grade AS (LFLG AS). Further analysis of the latter three patients with dobutamine stress echocardiography revealed pseudo-severe LFLG AS in two, and true-severe AS in one patient.
CONCLUSION
The prevalence of moderate to severe AS is 9% in our population of CA patients, the majority of whom have AL amyloidosis. Dobutamine echocardiography seems to be appropriate for the further characterization of patients with LFLG AS, even with normal ejection fraction.
Topics: Aged; Amyloidosis; Aortic Valve Stenosis; Cardiomyopathies; Echocardiography; Female; Humans; Magnetic Resonance Imaging; Male; Middle Aged; Retrospective Studies
PubMed: 31878928
DOI: 10.1186/s12947-019-0182-y -
Journal of Vascular Surgery Sep 2017Postoperative delirium (PODE) remains a common complication after vascular surgery procedures although the exact pathogenesis remains unclear, mainly because of its... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Postoperative delirium (PODE) remains a common complication after vascular surgery procedures although the exact pathogenesis remains unclear, mainly because of its multifactorial character. The aim of this systematic review was to evaluate pooled data on potential risk factors for PODE in patients undergoing vascular surgery procedures.
METHODS
A systematic literature review was conducted conforming to established criteria to identify eligible articles published from 1990 to 2016. Eligible studies evaluated potential risk factors for PODE after vascular surgery procedures, using both univariate and multivariate analysis. PODE was defined as a disturbance of consciousness with reduced ability to focus, sustain, or shift attention after vascular surgery procedures and was diagnosed in all studies using well-established criteria. Only risk factors reported in at least four studies were included in this review. Pooled results were calculated, and further multivariate regression analysis was conducted.
RESULTS
Overall, nine studies (published from 2003 to 2015) including 2388 patients in total were evaluated (457 with and 1931 without PODE). Patients with PODE were older (73.27 vs 69.87 years; P < .0001) and showed a higher male sex rate (78.1% vs 73.5%; P = .043). Open aortic surgery was the most frequent procedure in this analysis, followed by lower limb revascularization. Patients with PODE also showed higher rates of diabetes mellitus, hypertension, cardiac disease, and neurologic disease; lower hemoglobin level; larger duration of surgery; longer hospital and intensive care unit stay; and higher blood loss. Mean age (odds ratio [OR], 3.44; 95% confidence interval [CI], 2.933-4.034; P < .0001), hypertension (OR, 1.94; 95% CI, 1.469-2.554; P < .0001), cardiac disease (OR, 3.16; 95% CI, 2.324-4.284; P < .0001), open aortic surgery (OR, 1.74; 95% CI, 1.421-2.143; P < .0001), blood loss (OR, 1.01; 95% CI, 1.007-1.010; P < .0001), hospital stay (OR, 2.26; 95% CI, 1.953-2.614; P <. 0001), and intensive care unit stay (OR, 6.12; 95% CI, 4.699-7.957; P < .0001) were identified as the strongest risk predictors for PODE, followed by male sex, diabetes mellitus, neurologic disease, and history of smoking. However, body mass index, renal failure, preoperative hemoglobin level, and general anesthesia were not found to be risk factors for PODE in such patients.
CONCLUSIONS
This study has confirmed that PODE after vascular surgery procedures is a multifactorial disease, and several independent risk factors have been identified. However, pooled data regarding the effect of PODE on primary outcomes after vascular surgery procedures are still lacking. The results of this review could contribute to the designation of future prediction models and improve prevention of PODE in these patients.
Topics: Aged; Delirium; Female; Humans; Male; Odds Ratio; Risk Assessment; Risk Factors; Treatment Outcome; Vascular Surgical Procedures
PubMed: 28583731
DOI: 10.1016/j.jvs.2017.03.439 -
Frontiers in Cardiovascular Medicine 2022Patient-prosthesis mismatch (PPM) remains one out of many factors to be considered during decision-making for the treatment of aortic valve pathologies. The idea of...
Patient-prosthesis mismatch (PPM) remains one out of many factors to be considered during decision-making for the treatment of aortic valve pathologies. The idea of adequate sizing of a prosthetic heart valve was established by Rahimtoola already in 1978. In this article, the author described the phenomenon that the orifice area of a prosthetic heart valve may be too small for the individual patient. PPM is assessed by measurement or projection of the prosthetic effective orifice area indexed to body surface area (iEOA), while it is recommended to use different cut point values for non-obese and obese patients for the categorization of moderate and severe PPM. Several factors influence the accuracy of both the projected and the measured iEOA for PPM assessment, which leads to a certain number of false assignments to the PPM or no PPM group. Despite divergent findings on the impact of PPM on clinical outcomes, there is consensus that PPM should be avoided to prevent sequelae of increased prosthetic gradients after aortic valve replacement. To prevent PPM, it is required to anticipate the iEOA of the prosthesis prior to the procedure. The use of adequate reference tables, derived from echocardiographically measured mean effective orifice area (EOA) values from preferably large numbers of patients, is most appropriate to predict the iEOA. Such tables should be used also for transcatheter heart valves in the future. During the decision-making process, all available options should be taken into account for the individual patient. If the predicted size and type of a surgical prosthesis cannot be implanted, additional surgical procedures, such as annular enlargement with the Manougian technique, or alternative procedures, such as transcatheter aortic valve implantation (TAVI) can prevent PPM. PPM prevention for TAVI patients is a new field of interest and includes anticipation of the iEOA, prosthesis selection, and procedural strategies.
PubMed: 35433878
DOI: 10.3389/fcvm.2022.761917 -
European Journal of Vascular and... Jun 2022To investigate the clinical impact of coeliac artery (CA) coverage during thoracic endovascular aortic repair (TEVAR). (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To investigate the clinical impact of coeliac artery (CA) coverage during thoracic endovascular aortic repair (TEVAR).
METHODS
This systematic review and meta-analysis was conducted according to the PRISMA guidelines. Electronic databases were searched from 1989 to 2020 for studies reporting visceral ischaemia, spinal cord ischaemia (SCI), 30 day/in hospital mortality, endoleaks, re-intervention, and caudal stent graft migration following CA coverage in patients undergoing TEVAR. Meta-analysis was conducted using random effects modelling. The quality of the evidence was graded using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach.
RESULTS
Fifteen observational studies with 236 patients (108 male, age range 61.3 - 79 years) were included. The pooled visceral ischaemia rate was 13% with significant heterogeneity between studies (95% confidence intervals [CI] 4 - 24; I = 72%, p < .001). The SCI rate was 5% (95% CI 2 - 9; I = 0%); the 30 day/in hospital mortality was 4% (95% CI 1 - 7; I = 0%); the overall endoleak rate was 21% (95% CI 13 - 29; I = 35%) with a 5% (95% CI 0 - 13; I = 38%) rate of type Ib and 2% (95% CI 0 - 8; I = 43%) rate of type II endoleak from retrograde CA flow. The re-intervention rate was 13% (95% CI 6 - 22; I = 54%); the caudal stent graft migration rate was 3% (95% CI 0 - 9, I = 0%). The certainty of the body of evidence was judged to be very low for all outcomes.
CONCLUSION
CA coverage during TEVAR is associated with high rates of visceral ischaemia, spinal cord ischaemia, 30 day/in hospital mortality, endoleaks, and re-intervention. Although the literature is of poor quality and questions remain over effects estimates, there is evidence that CA coverage should be avoided if at all possible, during TEVAR.
REGISTRATION
PROSPERO registration number 244084.
Topics: Aged; Aorta, Thoracic; Aortic Aneurysm, Thoracic; Blood Vessel Prosthesis Implantation; Celiac Artery; Endoleak; Endovascular Procedures; Humans; Ischemia; Male; Middle Aged; Retrospective Studies; Risk Factors; Spinal Cord Ischemia; Stents; Treatment Outcome
PubMed: 35460890
DOI: 10.1016/j.ejvs.2022.02.026 -
Health Technology Assessment... Jan 2022The management of chronic thoracic aortic aneurysms includes conservative management, watchful waiting, endovascular stent grafting and open surgical replacement. The...
BACKGROUND
The management of chronic thoracic aortic aneurysms includes conservative management, watchful waiting, endovascular stent grafting and open surgical replacement. The Effective Treatments for Thoracic Aortic Aneurysms (ETTAA) study investigates timing and intervention choice.
OBJECTIVE
To describe pre- and post-intervention management of and outcomes for chronic thoracic aortic aneurysms.
DESIGN
A systematic review of intervention effects; a Delphi study of 360 case scenarios based on aneurysm size, location, age, operative risk and connective tissue disorders; and a prospective cohort study of growth, clinical outcomes, costs and quality of life.
SETTING
Thirty NHS vascular/cardiothoracic units.
PARTICIPANTS
Patients aged > 17 years who had existing or new aneurysms of ≥ 4 cm in diameter in the arch, descending or thoracoabdominal aorta.
INTERVENTIONS
Endovascular stent grafting and open surgical replacement.
MAIN OUTCOMES
Pre-intervention aneurysm growth, pre-/post-intervention survival, clinical events, readmissions and quality of life; and descriptive statistics for costs and quality-adjusted life-years over 12 months and value of information using a propensity score-matched subsample.
RESULTS
The review identified five comparative cohort studies (endovascular stent grafting patients, = 3955; open surgical replacement patients, = 21,197). Pooled short-term all-cause mortality favoured endovascular stent grafting (odds ratio 0.71, 95% confidence interval 0.51 to 0.98; no heterogeneity). Data on survival beyond 30 days were mixed. Fewer short-term complications were reported with endovascular stent grafting. The Delphi study included 20 experts (13 centres). For patients with aneurysms of ≤ 6.0 cm in diameter, watchful waiting was preferred. For patients with aneurysms of > 6.0 cm, open surgical replacement was preferred in the arch, except for elderly or high-risk patients, and in the descending aorta if patients had connective tissue disorders. Otherwise endovascular stent grafting was preferred. Between 2014 and 2018, 886 patients were recruited (watchful waiting, = 489; conservative management, = 112; endovascular stent grafting, = 150; open surgical replacement, = 135). Pre-intervention death rate was 8.6% per patient-year; 49.6% of deaths were aneurysm related. Death rates were higher for women (hazard ratio 1.79, 95% confidence interval 1.25 to 2.57; = 0.001) and older patients (age 61-70 years: hazard ratio 2.50, 95% confidence interval 0.76 to 5.43; age 71-80 years: hazard ratio 3.49, 95% confidence interval 1.26 to 9.66; age > 80 years: hazard ratio 7.01, 95% confidence interval 2.50 to 19.62; all compared with age < 60 years, < 0.001) and per 1-cm increase in diameter (hazard ratio 1.90, 95% confidence interval 1.65 to 2.18; = 0.001). The results were similar for aneurysm-related deaths. Decline per year in quality of life was greater for older patients (additional change -0.013 per decade increase in age, 95% confidence interval -0.019 to -0.007; < 0.001) and smokers (additional change for ex-smokers compared with non-smokers 0.003, 95% confidence interval -0.026 to 0.032; additional change for current smokers compared with non-smokers -0.034, 95% confidence interval -0.057 to -0.01; = 0.004). At the time of intervention, endovascular stent grafting patients were older (age difference 7.1 years; 95% confidence interval 4.7 to 9.5 years; < 0.001) and more likely to be smokers (75.8% vs. 66.4%; = 0.080), have valve disease (89.9% vs. 71.6%; < 0.0001), have chronic obstructive pulmonary disease (21.3% vs. 13.3%; = 0.087), be at New York Heart Association stage III/IV (22.3% vs. 16.0%; = 0.217), have lower levels of haemoglobin (difference -6.8 g/l, 95% confidence interval -11.2 to -2.4 g/l; = 0.003) and take statins (69.3% vs. 42.2%; < 0.0001). Ten (6.7%) endovascular stent grafting and 15 (11.1%) open surgical replacement patients died within 30 days of the procedure ( = 0.2107). One-year overall survival was 82.5% (95% confidence interval 75.2% to 87.8%) after endovascular stent grafting and 79.3% (95% confidence interval 71.1% to 85.4%) after open surgical replacement. Variables affecting survival were aneurysm site, age, New York Heart Association stage and time waiting for procedure. For endovascular stent grafting, utility decreased slightly, by -0.017 (95% confidence interval -0.062 to 0.027), in the first 6 weeks. For open surgical replacement, there was a substantial decrease of -0.160 (95% confidence interval -0.199 to -0.121; < 0.001) up to 6 weeks after the procedure. Over 12 months endovascular stent grafting was less costly, with higher quality-adjusted life-years. Formal economic analysis was unfeasible.
LIMITATIONS
The study was limited by small numbers of patients receiving interventions and because only 53% of patients were suitable for both interventions.
CONCLUSIONS
Small (4-6 cm) aneurysms require close observation. Larger (> 6 cm) aneurysms require intervention without delay. Endovascular stent grafting and open surgical replacement were successful for carefully selected patients, but cost comparisons were unfeasible. The choice of intervention is well established, but the timing of intervention remains challenging.
FUTURE WORK
Further research should include an analysis of the risk factors for growth/rupture and long-term outcomes.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN04044627 and NCT02010892.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Vol. 26, No. 6. See the NIHR Journals Library website for further project information.
Topics: Adolescent; Aged; Aged, 80 and over; Aortic Aneurysm, Thoracic; Child; Cohort Studies; Cost-Benefit Analysis; Endovascular Procedures; Female; Humans; Middle Aged; Prospective Studies; Quality of Life; Stents
PubMed: 35094747
DOI: 10.3310/ABUT7744 -
Journal of Clinical Medicine Jan 2024A growing body of evidence suggests that extrathoracic vascular accesses for transcatheter aortic valve replacement (TAVR) yield favorable outcomes and can be considered... (Review)
Review
A growing body of evidence suggests that extrathoracic vascular accesses for transcatheter aortic valve replacement (TAVR) yield favorable outcomes and can be considered as primary alternatives when the gold-standard transfemoral access is contraindicated. Data comparing the transcaval (TCv) to supra-aortic (SAo) approaches (transcarotid, transsubclavian, and transaxillary) for TAVR are lacking. We aimed to compare the outcomes and safety of TCv and SAo accesses for TAVR as alternatives to transfemoral TAVR. A systematic review with meta-analysis was performed by searching PubMed/MEDLINE and EMBASE databases for all articles comparing TCv-TAVR against SAo-TAVR published until September 2023. Outcomes included in-hospital or 30-day all-cause mortality (ACM) and postoperative complications. A total of three studies with 318 TCv-TAVR and 179 SAo-TAVR patients were included. No statistically significant difference was found regarding in-hospital or 30-day ACM (relative risk [RR] 1.04, 95% confidence interval [CI] 0.47-2.34, = 0.91), major bleeding, the need for blood transfusions, major vascular complications, and acute kidney injury. TCv-TAVR was associated with a non-statistically significant lower rate of neurovascular complications (RR 0.39, 95%CI 0.14-1.09, = 0.07). These results suggest that both approaches may be considered as first-line alternatives to transfemoral TAVR, depending on local expertise and patients' anatomy. Additional data from long-term cohort studies are needed.
PubMed: 38256589
DOI: 10.3390/jcm13020455 -
Journal of Vascular Surgery Nov 2019The objective was to characterize the growing body of literature regarding nonoperative management of blunt thoracic aortic injury (BTAI).
OBJECTIVE
The objective was to characterize the growing body of literature regarding nonoperative management of blunt thoracic aortic injury (BTAI).
METHODS
A systematic search of MedLine, Embase, and Cochrane Central was completed to identify original articles reporting injury characteristics and outcomes in patients with BTAI managed nonoperatively during their index hospitalization. Article title and abstract screening, full-text review, and data abstraction were performed in duplicate, with discrepancies resolved by a third reviewer. The quality of each study was evaluated using the Oxford Centre for Evidence-Based Levels of Evidence.
RESULTS
Of 2162 identified studies, 74 were included and reported on 8606 patients with BTAI who were managed nonoperatively between 1970 and 2016. Only one study was prospective. The median nonoperative sample size per study was 11 patients. The characterization of aortic injury grade differed across studies. Follow-up varied widely from 1 day to 118 months. Injury healing or improvement on follow-up imaging occurred in 34% (226 of 673 patients; reported in 37 studies), most often in the context of grade I intimal injury. Injury progression or requirement for a thoracic endovascular aneurysm repair for injury progression was 7.6% (66 of 873 patients; reported in 46 studies). A total of 37 studies reported aortic-related death, with an overall rate of 4.5% (37 of 827 patients) and a rate of 1% in grade I and II injuries (1 of 153 patients) and 18% in grade III and IV (9 of 50 patients).
CONCLUSIONS
An increasing number of reports support nonoperative management of grade I intimal injury, consistent with Society for Vascular Surgery guidelines. However, a retrospective interpretation of the determinants of management, heterogeneous injury characterization, and variable follow-up remain major limitations to the informed use of nonoperative management across all BTAI grades.
Topics: Aorta, Thoracic; Clinical Decision-Making; Conservative Treatment; Disease Progression; Endovascular Procedures; Humans; Injury Severity Score; Practice Guidelines as Topic; Societies, Medical; Specialties, Surgical; Treatment Outcome; Vascular System Injuries; Wounds, Nonpenetrating
PubMed: 31126762
DOI: 10.1016/j.jvs.2019.02.023 -
PloS One 2017Transcatheter aortic valve implantation (TAVI) has been demonstrated to be an alternative treatment for severe aortic stenosis in patients considered as high surgical... (Review)
Review
INTRODUCTION
Transcatheter aortic valve implantation (TAVI) has been demonstrated to be an alternative treatment for severe aortic stenosis in patients considered as high surgical risk. Since its first human implantation by Cribier et al., TAVI has been shown to increase survival rate and quality of life for high surgical risks patients. The objective of this study is to provide an overview of TAVI registries and the reporting clinical outcomes based on the VARC-2 definitions. In addition, the comparability and adherence of VARC-2 reporting within the identified TAVI registries was reviewed.
MATERIALS AND METHODS
A systematic review of TAVI registries reporting VARC-2 definitions has been performed in line with PRISMA guidelines in PubMed, ScienceDirect, Scopus databases and EMBASE. Based on VARC-2, patients' characteristics and procedure characteristics, 30-day clinical outcomes, 1-year mortality and composited endpoints were extracted from each registry's publications.
RESULTS
This review identified 466 studies that were potentially relevant, and 20 TAVI registries reported VARC-2 definitions involved in our present review. Of all 20 registries, an overall sample size of 12,583 patients was involved. The 30-day all-cause mortality ranged from 0 to 12.7%. From 20 registries, 14 registries reported the cardiovascular mortality at 30 days. 9 registries reported myocardial infarction (MI) rate based on VARC-2 definitions, and 7 registries reported peri-procedural MI rate (<72h). In our review, most of registries presented MI rates ranging from 0.5% to 2%. The majority of registries have reported complications such as bleeding, vascular complications and new pacemaker implantation.
CONCLUSION
Since the introduction of VARC definitions from 2011, VARC and VARC-2 definitions are still not systematically used by all TAVI studies. These endpoint definitions warrant a concise and systemic analysis of outcome measures. Reporting TAVI-outcome uniformly makes study result comparison feasible. This definitely will increase patient safety, additionally to provide sufficient evidence to support decision makers like regulatory bodies, HTA agencies, payers.
Topics: Aortic Valve Stenosis; Decision Support Techniques; Female; Guideline Adherence; Humans; Male; Quality of Life; Registries; Sample Size; Survival Analysis; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 28910289
DOI: 10.1371/journal.pone.0180815