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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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  1. Per O Vandvik, associate professor1 2,
  2. Catherine M Otto, professor3,
  3. Reed A Siemieniuk, methodologist4 5,
  4. Rodrigo Bagur, assistant clinical professor6,
  5. Gordon H Guyatt, distinguished professor4 7,
  6. Lyubov Lytvyn, methodologist8,
  7. Richard Whitlock, associate professor9 10,
  8. Trond Vartdal, consultant physician11,
  9. David Brieger, professor12,
  10. Bert Aertgeerts, professor13,
  11. Susanna Price, professor14,
  12. Farid Foroutan, graduate student4 15,
  13. Michael Shapiro, community representative and senior health informaticist for RTI International16,
  14. Ray Mertz, community representative17,
  15. Frederick A. Spencer, professor4 7
  1. 1Institute of Health and Society, Faculty of Medicine, University of Oslo, 0318 Oslo, Norway
  2. 2Department of Medicine, Innlandet Hospital Trust-division, Gjøvik, Norway
  3. 3Division of Cardiology, Department of Medicine, University of Washington School of Medicine, Seattle, Washington, USA 98195
  4. 4Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada L8S 4L8
  5. 5Department of Medicine, University of Toronto, Toronto, Ontario, Canada
  6. 6Division of Cardiology, London Health Sciences Centre and Department of Epidemiology & Biostatistics, Western University, London, Ontario, Canada N6A 3K7
  7. 7Department of Medicine, McMaster University, Hamilton, Ontario, Canada L8S 4L8
  8. 8Systematic Overviews through advancing Research Technology, Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario Canada M5G 0A4
  9. 9Department of Surgery, McMaster University, Hamilton, Ontario, Canada L8S 4L8
  10. 10Population Health Research Institute, Hamilton, Ontario, Canada L8L 2X2
  11. 11Department of Cardiology, Oslo University Hospital – Rikshospitalet, 0424 Oslo, Norway
  12. 12Concord Repatriation General Hospital, Concord, New South Wales 2139, Australia
  13. 13Department of Public Health and Primary Care, KU Leuven, 3000 Leuven, Belgium
  14. 14Royal Brompton Hospital, London SW3 6NP, UK
  15. 15Heart Failure/Transplant Program, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada M5G 2C4
  16. 16Chicago, Illinois, USA
  17. 17London, Ontario, Canada
  1. Corresponding author: P O Vandvik per.vandvik{at}gmail.com

In patients with symptomatic severe aortic stenosis but at lower risk of perioperative death, how do minimally invasive techniques compare with open surgery? Prompted by a recent trial, an expert panel produced these recommendations based on three linked rapid systematic reviews

What you need to know

  • New trial evidence confirms that transcatheter aortic valve insertion (TAVI), initially developed for patients with severe aortic stenosis who were unfit for surgical aortic valve replacement (SAVR), can be offered also to patients at low to intermediate surgical risk

  • Long term durability of TAVI valves remains highly uncertain

  • Age stratified recommendations reflect that TAVI is probably preferable to those over 75 years old, whereas SAVR is likely preferable to those under 75 years

A randomised controlled trial of transcatheter aortic valve insertion (TAVI) versus surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis was published in April 2016. The Partner 2 trial included 2032 people at intermediate surgical risk and favoured TAVI over open SAVR at two years for some outcomes.1 It had the potential to change practice.

Before the availability of TAVI, the only effective treatment for symptomatic severe aortic stenosis was SAVR with mechanical or bioprosthetic valves (fig 1). In practice, patients offered mechanical valves tend to be younger and must accept lifelong anticoagulation. The minimally invasive option, TAVI, was developed for patients who are unfit for surgery, in whom its use is recommended by major US and European guidelines.2 3

Fig 1 Flowchart for management of severe aortic stenosis (AS). Coloured boxes represent the recommendations covered by this article. AVR=aortic valve replacement, SAVR=surgical aortic valve replacement, TAVI=transcatheter aortic valve insertion

Severe aortic stenosis affects approximately 3 in 100 people over the age of 75 years.4 Patients typically experience symptoms of heart failure and reduced quality of life. Without aortic valve …

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