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Practice Rapid Recommendations

Transcatheter or surgical aortic valve replacement for patients with severe, symptomatic, aortic stenosis at low to intermediate surgical risk: a clinical practice guideline

BMJ 2016; 354 doi: https://doi.org/10.1136/bmj.i5085 (Published 28 September 2016) Cite this as: BMJ 2016;354:i5085
Choice of intervention for those with severe aortic stenosis Recommendations or Transcatheter aortic valve implantation Transfemoral TAVI Surgical aortic valve replacement SAVR Open-heart surgery, to remove the narrowed aortic valve. Replacement with tissue valve. Inserting a new valve into the aortic valve’s place without open heart surgery. Delivery is through the femoral artery. Population Favours TAVI Favours SAVR

Age 85+ Why? Strong Benefits outweigh harms for almost everyone.All or nearly all informed patients would likely want this option.

Comparison of benefits and harms Events per 1000 people – within 2 years Length of hospital stay Quality of evidence Favourstransfemoral TAVI Favours SAVR The uncertainty around long-term durability of TAVI valves is not likely to concern those over 85. These older patients are also likely to place a high value on avoiding open heart surgery. TAVI is likely to be a cost-effective alternative to SAVR for patients at low to moderate perioperative risk, but we have not identified any cost-effectiveness analyses to support this. Preferences and values Resourcing Only centres with sufficient expertise and an established TAVI team with experienced general and interventional cardiologists and cardiac surgeons should offer TAVI. Other Deaths Moderate / severe heart failure Strokes Life-threatening bleeds New onset atrial fibrillation Median days in hospital Pacemaker insertions Aortic valve reinterventions Aortic valve reinterventions 197 45 fewer 20 fewer 252 fewer 178 fewer 79 10 226 161 134 87 8 242 Events per 1000 people – within 10 years 226 99 3 92 413 312 69 12 7 fewer 134 fewer 18 fewer 4 fewer 92 134 fewer Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. High High quality evidence We are very confident in the evidence supporting the recommendation. Further research is very unlikely to change the estimates of effect. High High quality evidence We are very confident in the evidence supporting the recommendation. Further research is very unlikely to change the estimates of effect. Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. Very low Very low quality evidence Any estimate of effect is very uncertain. High High quality evidence We are very confident in the evidence supporting the recommendation. Further research is very unlikely to change the estimates of effect. See all 14 outcomes

Age 75–84 Why? Weak Benefits outweigh harms for the majority, but not for everyone. The majority of patients would likely want this option.

Comparison of benefits and harms Events per 1000 people – within 2 years Length of hospital stay Quality of evidence Favourstransfemoral TAVI Favours SAVR People who wish to avoid open-heart surgery are likely to favour TAVI. People who place more value on avoiding a second aortic valve placement are likely to choose surgery. Preferences and values Resourcing Only centres with sufficient expertise and an established TAVI team with experienced general and interventional cardiologists and cardiac surgeons should offer TAVI. Other Deaths Moderate Moderate / severe heart failure Strokes Life-threatening bleeds New onset atrial fibrillation Median days in hospital Pacemaker insertions Aortic valve reinterventions 122 30 fewer 20 fewer 252 fewer 178 fewer 79 10 226 161 134 87 8 152 Events per 1000 people – within 10 years Aortic valve reinterventions Very low 198 99 3 92 413 312 69 12 7 fewer 134 fewer 18 fewer 4 fewer 61 137 fewer Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. High High quality evidence We are very confident in the evidence supporting the recommendation. Further research is very unlikely to change the estimates of effect. High High quality evidence We are very confident in the evidence supporting the recommendation. Further research is very unlikely to change the estimates of effect. High High quality evidence We are very confident in the evidence supporting the recommendation. Further research is very unlikely to change the estimates of effect. Very low Very low quality evidence Any estimate of effect is very uncertain. High High quality evidence We are very confident in the evidence supporting the recommendation. Further research is very unlikely to change the estimates of effect. See all 14 outcomes TAVI is likely to be a cost-effective alternative to SAVR for patients at low to moderate perioperative risk, but we have not identified any cost-effectiveness analyses to support this.

Age 65–74 Why? Weak Benefits outweigh harms for the majority, but not for everyone. The majority of patients would likely want this option.

Comparison of benefits and harms Events per 1000 people – within 2 years Length of hospital stay Quality of evidence Favourstransfemoral TAVI Favours SAVR People who wish to avoid open-heart surgery are likely to favour TAVI. People who place more value on avoiding a second aortic valve placement are likely to choose surgery. Preferences and values Resourcing Only centres with sufficient expertise and an established TAVI team with experienced general and interventional cardiologists and cardiac surgeons should offer TAVI. Other Deaths Moderate / severe heart failure Strokes Life-threatening bleeds New onset atrial fibrillation Median days in hospital Pacemaker insertions Aortic valve reinterventions 73 19 fewer 14 fewer 252 fewer 178 fewer 56 10 226 161 134 87 8 92 Events per 1000 people – within 10 years Aortic valve reinterventions Very low 198 70 3 92 413 312 69 12 7 fewer 134 fewer 18 fewer 4 fewer 61 137 fewer Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. High High quality evidence We are very confident in the evidence supporting the recommendation. Further research is very unlikely to change the estimates of effect. High High quality evidence We are very confident in the evidence supporting the recommendation. Further research is very unlikely to change the estimates of effect. Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. Very low Very low quality evidence Any estimate of effect is very uncertain. High High quality evidence We are very confident in the evidence supporting the recommendation. Further research is very unlikely to change the estimates of effect. See all 14 outcomes TAVI is likely to be a cost-effective alternative to SAVR for patients at low to moderate perioperative risk, but we have not identified any cost-effectiveness analyses to support this.

Age under 65 Why? Strong Benefits outweigh harms for almost everyone.All or nearly all informed patients would likely want this option.

Comparison of benefits and harms Events per 1000 people – within 2 years Length of hospital stay Quality of evidence FavoursTransfemoral TAVI Favours SAVR Since durability of TAVI valves is unknown, younger people may place a high value on avoiding a second aortic valve placement. Preferences and values Resourcing Only centres with sufficient expertise and an established TAVI team with experienced general and interventional cardiologists and cardiac surgeons should offer TAVI. Other Deaths Moderate / severe heart failure Strokes Life-threatening bleeds New onset atrial fibrillation Median days in hospital Pacemaker insertions Aortic valve reinterventions 57 15 fewer 10 fewer 252 fewer 57 fewer 40 10 226 161 43 87 8 72 Events per 1000 people – within 10 years Aortic valve reinterventions 198 50 3 92 413 100 69 12 7 fewer 134 fewer 18 fewer 4 fewer 61 137 fewer Low Low quality evidence We have only low confidence in the evidence supporting the recommendation. Further research is very likely to have an important impact, which is likely to change the estimate of effect. Low Low quality evidence We have only low confidence in the evidence supporting the recommendation. Further research is very likely to have an important impact, which is likely to change the estimate of effect. Low Low quality evidence We have only low confidence in the evidence supporting the recommendation. Further research is very likely to have an important impact, which is likely to change the estimate of effect. Low Low quality evidence We have only low confidence in the evidence supporting the recommendation. Further research is very likely to have an important impact, which is likely to change the estimate of effect. Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. Low Low quality evidence We have only low confidence in the evidence supporting the recommendation. Further research is very likely to have an important impact, which is likely to change the estimate of effect. Very low Very low quality evidence Any estimate of effect is very uncertain. Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. See all 14 outcomes TAVI is likely to be a cost-effective alternative to SAVR for patients at low to moderate perioperative risk, but we have not identified any cost-effectiveness analyses to support this.
Key uncertainties The major uncertainty is the durability of TAVI valves which drives recommendations in favour of SAVR in younger patients.
Choice of intervention for people with severe aortic stenosiswho are unsuitable for TAVI by transfemoral approach Recommendations or Open-heart surgery, to remove the narrowed aortic valve. Replacement with tissue valve. A more direct delivery of the new valve, through the 6th or 5th intercostal space, into the the left ventricle. Population Favours TAVI Favours SAVR Transcatheter aortic valve implantation Transapical TAVI Surgical aortic valve replacement SAVR

All ages Why? Strong Benefits outweigh harms for almost everyone.All or nearly all informed patients would likely want this option.

Comparison of benefits and harms Events per 1000 people – within 2 years Length of hospital stay Quality of evidence Favourstransapical TAVI Favours SAVR Patients are likely to place a high value on the reduced risk of deaths and stroke with SAVR. There is also more certainty around the durability of valves used. Surgery is likely to constitute a cost-effective alternative to transapical TAVI, but we have not identified any cost-effectiveness analyses to support this. Preferences and values Resourcing Only centres with sufficient expertise and an established TAVI team with experienced general and interventional cardiologists and cardiac surgeons should offer TAVI. Other Deaths Moderate Moderate / severe heart failure Strokes Life-threatening bleeds New onset atrial fibrillation Median days in hospital Pacemaker insertions Aortic valve reinterventions 253 194 fewer 178 fewer 112 10 226 219 134 87 8 Events per 1000 people – within 10 years Aortic valve reinterventions 198 3 92 413 312 69 12 7 fewer 134 fewer 18 fewer 4 fewer 61 137 fewer 57 fewer 45 fewer 196 67 Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. Low Low quality evidence We have only low confidence in the evidence supporting the recommendation. Further research is very likely to have an important impact, which is likely to change the estimate of effect. Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. High High quality evidence We are very confident in the evidence supporting the recommendation. Further research is very unlikely to change the estimates of effect. High High quality evidence We are very confident in the evidence supporting the recommendation. Further research is very unlikely to change the estimates of effect. Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. Very low Very low quality evidence Any estimate of effect is very uncertain. Moderate Moderate quality evidence We are moderately confident in the evidence supporting the recommendation. Further research could have an important impact, which may change the estimates of effect. See all 14 outcomes

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Rapid Response:

Re: Transcatheter or surgical aortic valve replacement for patients with severe, symptomatic, aortic stenosis at low to intermediate surgical risk: a clinical practice guideline

In their letter, Yates, Uppal and Roberts state that there is no evidence to support the BMJ Rapid Recommendations for transfemoral aortic valve implantation (TAVI) in patients 75 years or older with severe symptomatic aortic stenosis (AS), at low or intermediate perioperative risk. We respectfully disagree as we report evidence of moderate to high quality for a benefit of TAVI for critical outcomes such as death and stroke and recognized the low quality evidence for another patient-important outcome, namely long term durability of TAVI-valves.1 Thoracic surgeons and others may well come to different conclusions after careful assessment of best current evidence. We believe an explanation of how we arrived at our age-stratified recommendations may be helpful, as previously outlined in The BMJ and in MAGICapp.(1,2)

BMJ Rapid Recommendations are developed according to widely accepted standards for trustworthy guidelines.(3) Beyond emphasizing key standards - such as managing conflicts of interests and involving patients in the process - we rigorously apply the GRADE system to rate certainty in best current evidence and to move from evidence to recommendations in a systematic and transparent manner.(4) The multidisciplinary guideline panel started by defining our clinical question in a PICO format as follows: (P) Adults with symptomatic severe AS at low to intermediate surgical risk; (I) TAVI; (C ) surgical aortic valve replacement (SAVR); (O) 14 important outcomes pre-defined by the guideline panel. A separate group then performed a high quality systematic review and meta-analysis of best current evidence. The systematic review included three well performed randomised controlled trials that compared outcomes with transfemoral TAVI versus SAVR, including 2576 patients at low to intermediate risk with a mean age of 81 years.(5)We also considered long term outcomes and durability of SAVR based on observational studies, published in a linked systematic review in the same issue of the BMJ.6

Readers can access detailed evidence summaries from the systematic review (GRADE Summary of Findings tables) in The BMJ publications and in MAGICapp, an online authoring and publication platform and clinical decision support tool.(1, 5-8) These evidence summaries support our age-stratified recommendations and display relative risks, absolute effects estimates and the certainty of the effect estimates for each outcome, stratified into 4 age groups. Rating of certainty is performed according to GRADE by the guideline panel and reflects to what extent the effect-estimates reported in the meta-analysis reflect the true effects of treatment.
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The letter’s authors discount the applicability of relative effects from randomised trials with an older mean age (81 years) to patients aged 75 to 85 years. We believe the relative effects will be similar and indeed, directly applicable to patients aged 75 to 85 years. They also question the applicability of evidence from patients at low and intermediate surgical risk to patients at lower risk. Subgroup analyses of randomised trials that enrolled patients at lower risk versus intermediate risk, (9,2) as well as within trial subgroup analyses, (10,11) suggest that the relative effects are similar for patients at intermediate and lower risk. The letter authors also apparently put a higher credibility on observational studies than randomised trials. We believe the latter have higher credibility. The letter’s authors believe that, faced with, over two years, a likely relative decrease in mortality of 21% (absolute approximately 3%), a likely relative decrease in stroke of 20% (absolute approximately 2%), a relative decrease in acute kidney injury of 62% (absolute approximately 5%) and a relative decrease in life-threatening or disabling bleeding of 61% (absolute approximately 25%) with TAVI versus SAVR, all or almost all patients in all age groups would choose, on the basis of speculative superiority over the long term, SAVR. We think, for patients over 65, they are wrong in their inference, and increasingly misguided in progressively older patients. Shared decision making, based on our evidence summaries, in those between 65 and 85 would establish whether the letter authors, or ourselves, have a better sense of patients’ values and preferences.

We agree that SAVR remains the procedure of choice in younger patients; with a strong recommendation for SAVR in those under age 65 years and a weak recommendation for SAVR in those age 65 to 75 years. Currently, we have limited data on durability of TAVI valves beyond 5 years. This is an important consideration given that most patients would likely choose a transcatheter-based option over surgery when a transfemoral approach is feasible. In contrast to transfemoral TAVI, comparison of outcomes with transapical TAVI versus SAVR strongly support SAVR as the preferred option, as detailed in our recommendations.

Clinicians and patients already are making decisions about TAVI versus SAVR, even in patients at lower surgical risk; we hope the BMJ Rapid Recommendations provide a helpful framework and that the clinical decision support tools can be used now to involve patients meaningfully in the decision making process. Neither the 2012 European Society of Cardiology or American College of Cardiology valvular heart disease guidelines addressed TAVI for patients at lower surgical risk, but several practice-changing studies have been approved in the interim and TAVI is approved for use in intermediate risk patients in the US.(12,13) We hope that updated versions of those guidelines will address this important clinical issue soon. In the meanwhile, the BMJ Rapid Recommendations are available to all.

Per Olav Vandvik
Catherine M. Otto
Reed A. Siemieniuk
Rodrigo Bagur
Gordon H. Guyatt
Richard Whitlock
Frederick A. Spencer

References:
1. Vandvik PO, Otto CM, Siemieniuk RA, et al. Transcatheter or surgical aortic valve replacement for patients with severe, symptomatic, aortic stenosis at low to intermediate surgical risk: a clinical practice guideline. BMJ 2016;354:i5085.
2. Siemieniuk RA, Macdonald H, Agoritsas T, Guyatt GH, Vandvik PO. Introduction to BMJ Rapid Recommendations. BMJ 2016;354:i5191, doi:10.1136/bmj.i5191
3. Laine C, Taichman DB, Mulrow C. Trustworthy clinical guidelines. Annals of internal medicine. 2011;154(11):774-775.
4. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. Bmj. 2008;336(7650):924-926.
5. Siemieniuk RA, Agoritsas T, Manja V, et al. Transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at low and intermediate risk: systematic review and meta-analysis. BMJ 2016;354:i5130
6. Foroutan F, Guyatt GH, O´Brien K, et al. Prognosis after surgical replacement with a bioprosthetic aortic valve in patients with severe aortic stenosis: systematic review of observational studies. BMJ 2016;354:i5065
7. Vandvik PO, Brandt L, Alonso-Coello P, et al. Creating clinical practice guidelines we can trust, use, and share: a new era is imminent. Chest. 2013;144(2):381-389.
8. BMJ Rapid Recommendations for Transcatheter Aortic Valve Implantation. https://www.magicapp.org/app#/guideline/1294
9. Søndergaard L, Steinbrüchel DA, Ihlemann N, et al. Two-Year Outcomes in Patients With Severe Aortic Valve Stenosis Randomized to Transcatheter Versus Surgical Aortic Valve Replacement: The All-Comers Nordic Aortic Valve Intervention Randomized Clinical Trial. Circ Cardiovasc Interv. 2016 Jun;9(6). pii: e003665. doi: 10.1161/CIRCINTERVENTIONS.115.003665
10. Leon MB, Smith CR, Mack MJ, et al. PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate Risk Patients. N Engl J Med 2016; 374:1609-20
11. Reardon MJ, Kleiman NS, Adams DH, et al. Outcomes in the Randomized CoreValve US Pivotal High Risk Trial in Patients With a Society of Thoracic Surgeons Risk Score of 7% or Less. JAMA Cardiol. 2016 Nov 1;1(8):945-949. doi: 10.1001/jamacardio.2016.2257.
12. Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC).; European Association for Cardio-Thoracic Surgery (EACTS)., Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Barón-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schäfers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J. 2012 Oct;33(19):2451-96. doi: 10.1093/eurheartj/ehs109.
13. Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jun 10;63(22):2438-88. doi: 10.1016/j.jacc.2014.02.537. Erratum in: J Am Coll Cardiol. 2014 Jun 10;63(22):2489.

Competing interests: No competing interests

02 January 2017
Per O Vandvik
MD
Catherine M Otto, Reed Siemieniuk, Rodrigo Bagur, Gordon H Guyatt, Fred A Spencer
Innlandet Hospital Trust-Division Gjøvik
Kyrre Greppsgt.11, 2819 GJØVIK, Norway