| Literature DB >> 33563630 |
Anja Fog Heen1, Lyubov Lytvyn2, Michael Shapiro3, Gordon Henry Guyatt2, Reed Alexander Cunningham Siemieniuk2, Yuan Zhang2, Veena Manja4,5, Per Olav Vandvik6, Thomas Agoritsas2,7.
Abstract
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. © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.Entities:
Keywords: aortic valve stenosis; heart valve prosthesis implantation; quality of health care; transcatheter aortic valve replacement
Mesh:
Year: 2021 PMID: 33563630 PMCID: PMC8327404 DOI: 10.1136/heartjnl-2020-318334
Source DB: PubMed Journal: Heart ISSN: 1355-6037 Impact factor: 5.994
Figure 1PRISMA study flow diagram. PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
GRADE summary of findings
| Health state/outcome (timeframe) | Study design | Estimate of effect, mean (SD) unless otherwise stated | Certainty of evidence | Interpretation of finding |
| Mortality (30 days) | Adaptive swing weighting (109*) | Maximum acceptable increase in risk in exchange from SAVR to TAVI =3.7% (3.0)†. | Very low§¶** | The risk willingness of trading a reduction in mortality risk (30 days) for a less invasive procedure was uncertain and highly variable. |
| Mortality and aortic stenosis-related symptoms and concerns (lifetime) | Standard gamble (429) | Median risk willingness=25% (IQR 25%–50%). | Low§¶ | The risk willingness of trading a reduction in mortality risk for full health with the procedure is highly variable among participants and across risk groups. |
| Disabling non-fatal stroke (30 days) | Adaptive swing weighting (110*) | Maximum acceptable increase in risk in exchange from SAVR to TAVI=6.7% (5.7)†. | Very low§¶** | The risk willingness of trading a reduction in risk of disabling stroke for a less invasive procedure was uncertain and highly variable. |
| Independence (30 days) | Adaptive swing weighting (131*) | Maximum acceptable reduction in benefit in exchange from SAVR to TAVI=13.9% (11.8)†. | Very low§¶** | The risk willingness of trading an increase of independence for a less invasive procedure was uncertain and highly variable. |
| Requirement for dialysis (1 year) | Adaptive swing weighting (132*) | Maximum acceptable increase in risk in exchange from SAVR to TAVI=6.2% (5.6)†. | Very low§¶** | The risk willingness of trading a reduction in the requirement for dialysis at 1 year for a less invasive procedure was uncertain and highly variable. |
| New permanent pacemaker (1 year) | Adaptive swing weighting (131*) | Maximum acceptable increase in risk in exchange from SAVR to TAVI=7.0% (5.7)‡. | Very low§¶** | The risk willingness of trading a reduction in permanent pacemaker insertion for a less invasive procedure was uncertain and highly variable. |
| Time over which the procedure has been proven to work | Adaptive swing weighting (131*) | Maximum acceptable decrease in duration that the procedure is known to work in exchange from SAVR to TAVI=17.4 years (16.9)‡. | Very low§¶** | The risk willingness of trading the expected duration or a new valve for a less invasive procedure was uncertain and highly variable. |
*The total sample size was 219 participants, but they were not presented with all outcomes.
†Minimum acceptable reduction in benefit in exchange for reducing procedure invasiveness from ‘invasive’ to ‘minimally invasive’.
‡Maximum acceptable increase in risk in exchange for reducing procedure invasiveness from ‘invasive’ to ‘minimally invasive’.
§Serious risk of bias.
¶Serious imprecision.
**Serious indirectness.
GRADE, Grading of Recommendations Assessment, Development and Evaluation; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve insertion.
Study and participant demographics
| Study | Country | Study design | Sample size | Patient population | Previous TAVI/SAVR | Age (years), | Sex | Surgical risk | Heart failure symptoms | Quality of life, symptoms, function, n |
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| Marsh | USA | Adapted swing weighting | 219† | Self-reported aortic stenosis; received treatment within 10 years or experiencing limitations in their physical activity due to aortic stenosis. | Undergone aortic stenosis treatment (unspecified)=80.4% | 19–39=26.5%; 40–59=33.8%; 60–74=25.1%; 75–89=13.2%; 90+=1.4% | 91 (41.6) | NR | Class I=78 (35.6%); class II=101 (46.1%); class III=40 (18.3%) | General health (past week): very good=55; good=85; fair=65; poor=13; very poor=1 |
| Hussain | Norway | Standard gamble | 439 | Severe aortic stenosis; referred for aortic valve treatment. | NR | 75 (11) | 264 (60) | 11.9% (7.50%–17.10%) | Class I=11 (13%); class II=43 (50%); class III/IV=46 (53%)‡ | SF-36§¶ |
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| Coylewright | USA | Interview | 46 | Severe aortic stenosis; assessed for aortic valve treatment. | NR | 68–74=5; | 25 (54.3) | 9% (4.9%)§ | NR | KCCQ-12¶** |
| Olsson | Sweden | Interview | 24 | Severe aortic stenosis. | NR | 80.7 (7.4) | 15 (62.5) | NR | Class III=11 (46%); class IV=13 (54%) | NR |
| Skaar | Norway | Interview | 10 | Severe aortic stenosis. | NR | 70–79=3; | 4 (40) | Logistic EuroSCORE <10=2; 10–20=7; >20=1 | Class I=1 (10%); class II=7 (70%); class III=2 (20%) | SPPB |
| Lauck | Canada | Interview | 15 | Severe symptomatic aortic stenosis. | Undergone cardiac surgery (unspecified)=6 | 86 (75–92)†† | 9 (60) | 6.4% (2.6%–16.3%) | Class II=11 (73%), | All but one participant were able to complete all activities of daily living. |
| Ontario Health Technology Assessment Series | Canada | Interview | 10 | Aortic stenosis. | Undergone TAVI=9, undergone SAVR=1 | NR | NR | NR | NR | NR |
| Frank | Canada | Interview | 333 | Patients with aortic stenosis considering treatment options. | None | 80.5 (52–97)†† | 181 (54.5) | NR | NR | NR |
*NYHA class I=no symptoms and no limitation in ordinary physical activity; class II=mild symptoms and slight limitation during ordinary activity; class III=marked limitation in activity due to symptoms, even during less than ordinary activity, comfortable only at rest; class IV=severe limitations, experiences symptoms even while at rest, mostly bedbound patients.
†Baseline variables reported for 219 participants, but outcome data are for 109–132 participants (ie, not all participants were asked about all outcomes).
‡NYHA classification only reported for 86 of 439 participants. Class III and IV grouped together but only 2% were class IV.
§Mean, SD.
¶Maximum score=100.
**Median, range.
††Mean, range.
KCCQ-12, Kansas City Cardiomyopathy Questionnaire; NR, not reported; NYHA, New York Heart Association; SAVR, surgical aortic valve replacement; SF-36, Short-Form 36; SPPB, Short Physical Performance Battery; STS, Society of Thoracic Surgeons; TAVI, transcatheter aortic valve insertion.