-
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 -
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 -
Frontiers in Medicine 2022Cardiac amyloidosis (CA) has been recently recognized as a condition frequently associated with aortic stenosis (AS). The aim of this study was to evaluate: the main...
BACKGROUND
Cardiac amyloidosis (CA) has been recently recognized as a condition frequently associated with aortic stenosis (AS). The aim of this study was to evaluate: the main characteristics of patients with AS with and without CA, the impact of CA on patients with AS mortality, and the effect of different treatment strategies on outcomes of patients with AS with concomitant CA.
MATERIALS AND METHODS
A detailed search related to CA in patients with AS and outcomes was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Seventeen studies enrolling 1,988 subjects (1,658 AS alone and 330 AS with CA) were included in the qualitative and quantitative analysis of main patients with AS characteristics with and without CA, difference in mortality, and treatment strategy.
RESULTS
The prevalence of CA resulted in a mean of 15.4% and it was even higher in patients with AS over 80 years old (18.2%). Patients with the dual diagnosis were more often males, had lower body mass index (BMI), were more prone to have low flow, low gradient with reduced left ventricular ejection fraction AS phenotype, had higher E/A and E/e', and greater interventricular septum hypertrophy. Lower Sokolow-Lyon index, higher QRS duration, higher prevalence of right bundle branch block, higher levels of -terminal pro-brain natriuretic peptide, and high-sensitivity troponin T were significantly associated with CA in patients with AS. Higher overall mortality in the 178 patients with AS + CA in comparison to 1,220 patients with AS alone was observed [odds ratio (OR) 2.25, = 0.004]. Meta-regression analysis showed that younger age and diabetes were associated with overall mortality in patients with CS with CA (-value -3.0, = 0.003 and -value 2.5, = 0.013, respectively). Finally, patients who underwent surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) had a similar overall mortality risk, but lower than medication-treated only patients.
CONCLUSION
Results from our meta-analysis suggest that several specific clinical, electrocardiographic, and echocardiographic features can be considered "red flags" of CA in patients with AS. CA negatively affects the outcome of patients with AS. Patients with concomitant CA and AS benefit from SAVR or TAVI.
PubMed: 35355593
DOI: 10.3389/fmed.2022.858281 -
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 Vascular Surgery Apr 2022We sought to evaluate the impact of obesity on perioperative mortality and complication rates in patients undergoing endovascular aortic repair (EVAR) and open surgical... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
We sought to evaluate the impact of obesity on perioperative mortality and complication rates in patients undergoing endovascular aortic repair (EVAR) and open surgical repair (OSR) for abdominal aortic aneurysms.
METHODS
A systematic review of all studies reporting abdominal aortic aneurysm treatment perioperative (30-day) outcomes in obese patients (body mass index ≥30 kg/m). The primary outcome was 30-day mortality. Secondary outcomes included cardiac complications, respiratory complications, wound complication, renal complications, and neurological complications at 30 days. These outcomes were pooled for meta-analysis. Analysis first compared obese vs nonobese patients undergoing EVAR and OSR then compared EVAR with OSR in obese patients.
RESULTS
We identified seven observational studies with 14,971 patients (11,743 EVAR, 3228 OSR). Obese patients undergoing EVAR had lower 30-day mortality (1.5%) compared with nonobese patients (2.2%) (odds ratio [OR], 0.69; 95% confidence interval [CI], 0.50-0.96; P = .03; I = 0%; Grade of evidence: low). In OSR, obese patients (5.0%) had similar 30-day mortality to nonobese patients (5.7%) (OR, 0.92; 95% CI, 0.70-1.20; P = .54; I = 0%; Grade of evidence: low). Wound complications were higher in obese patients undergoing OSR (OR, 2.30; 95% CI, 1.74-3.06; P < .001; I = 0%; Grade of evidence: low). EVAR was associated with a lower 30-day mortality (1.5%) compared with OSR (5.0%) in obese patients (OR, 0.23; 95% CI, 0.12-0.46; P < .001; I = 38%; Grade of evidence: low). Cardiac, respiratory, wound, renal, and neurological complications were also reduced in EVAR.
CONCLUSIONS
Obese patients have lower 30-day mortality in EVAR compared with nonobese patients. In OSR, obese patients had similar 30-day mortality but higher wound complications compared with nonobese patients. Obese patients otherwise have similar cardiopulmonary complication rates compared with nonobese patients in both EVAR and OSR. EVAR offers lower 30-day mortality and morbidity compared with OSR in obese patients. This study suggests that EVAR is superior to OSR in obese patients.
Topics: Aortic Aneurysm, Abdominal; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Humans; Obesity; Postoperative Complications; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome
PubMed: 34785300
DOI: 10.1016/j.jvs.2021.10.053 -
Journal of Vascular Surgery Aug 2021We investigated whether the well-documented perioperative survival advantage of emergency endovascular aneurysm repair (EVAR) compared with open repair would be... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
We investigated whether the well-documented perioperative survival advantage of emergency endovascular aneurysm repair (EVAR) compared with open repair would be sustained during follow-up.
METHODS
A systematic review conforming to the PRISMA (preferred reporting items for systematic reviews and meta-analyses) statement standards was conducted to identify studies that had reported the follow-up outcomes of endovascular vs open repair for ruptured abdominal aortic aneurysms. Electronic bibliographic sources (MEDLINE [medical literature analysis and retrieval system online], Embase [Excerpta Medica database], CINAHL [cumulative index to nursing and allied health literature], and CENTRAL [Cochrane central register of controlled trials]) were interrogated using the Healthcare Databases Advanced Search interface (National Institute for Health and Care Excellence, London, United Kingdom). A time-to-event data meta-analysis was performed using the inverse variance method, and the results were reported as summary hazard ratios (HRs) and associated 95% confidence intervals (CIs). Mixed effects regression was applied to investigate the outcome changes over time. The quality of the body of evidence was appraised using the GRADE (grades of recommendation, assessment, development, and evaluation) system.
RESULTS
Three randomized controlled trials and 22 observational studies reporting a total of 31,383 patients were included in the quantitative synthesis. The mean follow-up duration across the studies ranged from 232 days to 4.9 years. The overall all-cause mortality was significantly lower after EVAR than after open repair (HR, 0.79; 95% CI, 0.73-0.86). However, the postdischarge all-cause mortality was not significantly different (HR, 1.10; 95% CI, 0.85-1.43). The aneurysm-related mortality, which was reported by one randomized controlled trial, was not significantly different between EVAR and open repair (HR, 0.89; 95% CI, 0.69-1.15). Meta-regression showed the mortality difference in favor of EVAR was more pronounced in more recent studies (P = .069) and recently treated patients (P = .062). The certainty for the body of evidence for overall and postdischarge all-cause mortality was judged to be low and that for aneurysm-related mortality to be high.
CONCLUSIONS
EVAR showed a sustained mortality benefit during follow-up compared with open repair. A wider adoption of an endovascular-first strategy is justified.
Topics: Aortic Aneurysm, Abdominal; Aortic Rupture; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Humans; Postoperative Complications; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome
PubMed: 33819523
DOI: 10.1016/j.jvs.2021.03.019 -
Heart (British Cardiac Society) Aug 2021The review aims to summarise evidence addressing patients' values, preferences and practical issues on deciding between transcatheter aortic valve insertion (TAVI) and...
The review aims to summarise evidence addressing patients' values, preferences and practical issues on deciding between transcatheter aortic valve insertion (TAVI) and surgical aortic valve replacement (SAVR) for aortic stenosis. We searched databases and grey literature until June 2020. We included studies of adults with aortic stenosis eliciting values and preferences about treatment, excluding medical management or palliative care. Qualitative findings were synthesised using thematic analysis, and quantitative findings were narratively described. Evidence certainty was assessed using CERQual (Confidence in the Evidence from Reviews of Qualitative Research) and GRADE (Grading of Recommendations Assessment, Development and Evaluation). We included eight studies. Findings ranged from low to very low certainty. Most studies only addressed TAVI. Studies addressing both TAVI and SAVR reported on factors affecting patients' decision-making along with treatment effectiveness, instead of trade-offs between procedures. Willingness to accept risk varied considerably. To improve their health status, participants were willing to accept higher mortality risk than current evidence suggests for either procedure. No study explicitly addressed valve reintervention, and one study reported variability in willingness to accept shorter duration of known effectiveness of TAVI compared with SAVR. The most common themes were desire for symptom relief and improved function. Participants preferred minimally invasive procedures with shorter hospital stay and recovery. The current body of evidence on patients' values, preferences and practical issues related to aortic stenosis management is of suboptimal rigour and reports widely disparate results regarding patients' perceptions. These findings emphasise the need for higher quality studies to inform clinical practice guidelines and the central importance of shared decision-making to individualise care fitted to each patient.
Topics: Aortic Valve Stenosis; Decision Making; Heart Valve Prosthesis Implantation; Humans; Patient Preference; Quality-Adjusted Life Years; Risk Adjustment; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 33563630
DOI: 10.1136/heartjnl-2020-318334 -
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 -
European Journal of Vascular and... Mar 2021To investigate whether a percutaneous approach has better clinical outcomes than surgical access for standard endovascular repair of abdominal aortic aneurysms. (Meta-Analysis)
Meta-Analysis
Editor's Choice - Percutaneous Access Does Not Confer Superior Clinical Outcomes Over Cutdown Access for Endovascular Aneurysm Repair: Meta-Analysis and Trial Sequential Analysis of Randomised Controlled Trials.
OBJECTIVE
To investigate whether a percutaneous approach has better clinical outcomes than surgical access for standard endovascular repair of abdominal aortic aneurysms.
DATA SOURCES
MEDLINE and Embase were searched using the Healthcare Databases Advanced Search interface developed by the National Institute for Health and Care Excellence.
REVIEW METHODS
Randomised controlled trials (RCTs) that compared percutaneous and cutdown endovascular aneurysm repair (EVAR) were considered. Pooled effect estimates were calculated using the odds ratio (OR), risk difference, or mean difference (MD) and 95% confidence interval (CI). The Mantel-Haenszel or inverse variance statistical method was used as appropriate. Trial sequential analysis was performed to quantify the available evidence and control for the risk of type 1 and type 2 error. Risk of bias was assessed with the revised tool developed by Cochrane and the quality of evidence was graded using the GRADE system (Grades of Recommendation, Assessment, Development and Evaluation).
RESULTS
Four RCTs were identified, reporting a total of 368 patients and 530 access sites. Meta-analysis showed no difference in access site complications or infection, post-operative bleeding/haematoma, access related arterial injury, femoral artery occlusion, pseudo-aneurysm, or peri-operative mortality between percutaneous and cutdown EVAR. Seroma/lymphorrhoea was significantly less frequent after percutaneous EVAR (0%) compared with cutdown EVAR (3%; OR 0.18 [95% CI 0.04-0.83]) and the procedure time was significantly shorter (MD -11.53 minutes; 95% CI -15.71-7.34), but hospital length of stay was not different between treatments. Neither the O'Brien-Fleming boundaries nor the futility boundaries were crossed by the cumulative Z curve, and the required information size was not reached for any of the outcomes. All trials were judged to be high risk of bias or have some concerns, and the level of the body of evidence was low or very low for all outcomes.
CONCLUSION
The evidence is very uncertain about the effect of percutaneous EVAR on clinically important outcomes.
Topics: Aortic Aneurysm, Abdominal; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Humans; Postoperative Complications
PubMed: 33309488
DOI: 10.1016/j.ejvs.2020.11.008 -
Ontario Health Technology Assessment... 2020Surgical aortic valve replacement (SAVR) is the conventional treatment for patients with severe aortic valve stenosis at low surgical risk. Transcatheter aortic valve... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Surgical aortic valve replacement (SAVR) is the conventional treatment for patients with severe aortic valve stenosis at low surgical risk. Transcatheter aortic valve implantation (TAVI) is a less invasive procedure. We conducted a health technology assessment (HTA) of TAVI for patients with severe aortic valve stenosis at low surgical risk, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding TAVI, and patient preferences and values.
METHODS
We used the 2016 Health Quality Ontario HTA on TAVI as a source of eligible studies and performed a systematic literature search for studies published since the 2016 review. Eligible primary studies identified both through the 2016 HTA and through our complementary literature search were used in a de novo analysis. We assessed the risk of bias of each included study using the Cochrane risk-of-bias tool and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria.An applicable, previously conducted cost-effectiveness analysis was available, so we did not conduct a primary economic evaluation. We analyzed the budget impact of publicly funding TAVI in people at low surgical risk in Ontario. We also performed a literature survey of the quantitative evidence of preferences and values of patients for TAVI. The Canadian Agency for Drugs and Technologies in Health (CADTH) conducted a review to evaluate the qualitative literature on patient and provider preferences and values for TAVI. To contextualize the potential value of TAVI, we spoke with people with severe aortic valve stenosis.
RESULTS
We identified two randomized controlled trials that compared TAVI (transfemoral route) and SAVR in patients with severe aortic valve stenosis at low surgical risk. Both studies have an ongoing follow-up of 10 years, but 1-year and limited 2-year follow-up results are currently available. At 30 days, compared with SAVR, TAVI had a slightly lower risk of mortality (risk difference -0.8%, 95% confidence interval [CI] -1.5% to -0.1%, GRADE: Moderate) and disabling stroke (risk difference -0.8%, 95% CI -1.8% to -0.2%, GRADE: Moderate), and resulted in more patients with symptom improvement (risk difference 11.8%, 95% CI 8.2% to 15.5%, GRADE: High) and in a greater improvement in quality of life (GRADE: High). At 1 year, TAVI and SAVR were similar with regard to mortality (GRADE: Low), although TAVI may result in a slightly lower risk of disabling stroke (GRADE: Moderate). Both TAVI and SAVR resulted in a similar improvement in symptoms and quality of life at 1 year (GRADE: Moderate). Compared with SAVR, TAVI had a higher risk of some complications and a lower risk of others.Device-related costs for TAVI (about $25,000) are higher than for SAVR (about $6,000). A published cost-effectiveness analysis conducted from an Ontario Ministry of Health perspective showed TAVI to be more expensive and, on average, slightly more effective (i.e., it was associated with more quality-adjusted life-years [QALYs]) than SAVR. Compared with SAVR, the incremental cost-effectiveness ratios (ICERs) were $27,196 per QALY and $59,641 per QALY for balloon-expandable and self-expanding TAVI, respectively. Balloon-expandable TAVI was less costly (by $2,330 on average) and slightly more effective (by 0.02 QALY on average) than self-expanding TAVI. Among the three interventions, balloon-expandable TAVI had the highest probability of being cost-effective. It was the preferred option in 53% and 59% of model iterations, at willingness-to-pay values of $50,000 and $100,000 per QALY, respectively. Self-expanding TAVI was preferred in less than 10% of iterations. The budget impact of publicly funding TAVI in Ontario is estimated to be an additional $5 to $8 million each year for the next 5 years. The budget impact could be significantly reduced with reductions in the device price.We did not find any quantitative or qualitative evidence on patient preferences and values specific to the low-risk surgical group. Among a mixed or generally high-risk and population, people typically preferred the less invasive nature and the faster recovery time of TAVI compared with SAVR, and people were satisfied with the TAVI procedure. Patients with severe aortic valve stenosis at low surgical risk and their caregivers perceived that TAVI minimized pain and recovery time. Most patients who had TAVI returned to their usual activities more quickly than they would have if they had had SAVR. Our direct patient and caregiver consultations indicated a preference for TAVI over SAVR.
CONCLUSIONS
Both TAVI (transfemoral route) and SAVR resulted in improved patient symptoms and quality of life during the 1 year of follow-up. The TAVI procedure is less invasive and resulted in greater symptom improvement and quality of life than SAVR 30 days after surgery. The TAVI procedure also resulted in a small improvement in mortality and disabling stroke at 30 days. At 1 year, TAVI and SAVR were similar with regard to mortality, although TAVI may result in a slightly lower risk of disabling stroke. According to the study authors, longer follow-up is needed to better understand how long TAVI valves last and to draw definitive conclusions on the long-term outcomes of TAVI compared with SAVR beyond 1 year.The TAVI procedure might be cost-effective for patients at low surgical risk; however, there is some uncertainty in this result. We estimated that the additional cost to provide public funding for TAVI in people with severe aortic valve stenosis at low surgical risk would range from about $5 million to $8 million over the next 5 years.Among a mixed or generally high-risk population, people typically preferred the less invasive nature and the faster recovery time of TAVI compared with SAVR.
Topics: Aged; Aortic Valve Stenosis; Cost-Benefit Analysis; Heart Valve Prosthesis Implantation; Humans; Ontario; Quality of Life; Quality-Adjusted Life Years; Risk Assessment; Severity of Illness Index; Technology Assessment, Biomedical; Transcatheter Aortic Valve Replacement
PubMed: 33240455
DOI: No ID Found