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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

Dear Sir,

We read the Rapid Recommendation by Vandvik et al [1] published 28th September 2016 with interest. In this article the authors recommend transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement (SAVR) in all patients with symptomatic aortic stenosis, 75 years and older, irrespective of surgical risk. There is no evidence to support this recommendation.

Surgical aortic valve replacement remains the gold standard treatment for patients with symptomatic aortic stenosis. There is good evidence to support excellent long term outcomes. Two recent publications in BMJ have demonstrated excellent long term outcomes of surgical aortic valve replacement. A retrospective study in the UK of patients undergoing SAVR with a mean age of 75 years showed a hospital mortality of only 1.5% and a median survival of 11 years [2]. A large meta analysis by the same authors as this recommendation, concluded that SAVR using a bioprosthetic valve conveys a survival close to the general population of the same age [3].

The only randomised trial of TAVI versus SAVR in low risk patients was the NOTION trial which concluded equivalence at one year in terms of survival [4]. The PARTNER 2A trial was designed to compare TAVI and SAVR in intermediate risk patients [5]. In fact, the mean age of these patients was 81 years, 93.3% had an STS score of 4 or more, half had previous cardiac surgery, a third had COPD and half were considered to be frail. These characteristics would be considered high risk by many cardiac surgeons. Even in these patients there was no survival benefit of TAVI over SAVR.

Both of these studies look at only short term outcomes up to two years. However, we must be considering long term outcomes for a 75 year old requiring aortic valve intervention.

Both European and American guidelines only recommend TAVI in patients at high surgical risk [6.7]. The UK TAVI trial is currently recruiting intermediate risk patients and therefore such patients should only be treated as part of a clinical trial.

In conclusion, we do not feel that this Rapid Recommendation accurately reflects current best evidence. Surgical aortic valve replacement should have a strong recommendation in patients at low and intermediate risk in all age groups. Those at high surgical risk should have equivalent recommendation. All patients should be discussed by an experienced Heart Team and be given accurate information regarding current best evidence.

Martin T Yates, Rakesh Uppal, Neil Roberts
Department of Cardiothoracic Surgery, Barts Heart Centre, London

References:
1. Vandvik PO, Otto CO, Siemieniuk RA, Bagur R, Guyatt GH, Lytvyn L et al. Transcatheter or surgical aortic valve replacement for patient with severe, symptomatic, aortic stenosis at low to intermediate surgical risk: a clinical practice guideline. BMJ 2016; 354: i5085

2. Sharabiani MT, Fiorentino F, Angelini GD, Patel NN. Long term survival after surgical aortic valve replacement among patient over 65 years of age. Open Heart 2016; 3(1): 1-8

3. Foroutan F, Guyatt GH, O’Brien KO, Bain E, Stein M, Bhagra S et al. Prognosis after surgical replacement with a bioprosthetic aortic valve with severe symptomatic aortic stenosis: systemic review of observational studies. BMJ 2016; 354: i5065

4. Thyregod HGH, Steinbruchel DA, Ihlemann K, Nissen H, Kjeldsen BJ, Petursson P et al. Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stensosis. JACC 2015; 65(20): 2184-2194

5. Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK et al. Transcatheter or Surgical Aortic Valve Replacement in Intermediate Risk Patients. NEJM 2016; 374(17): 1609-1620

6. Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias, Baumbartner H et al. Guidelines on the management of valvular heart disease. European Heart Journal 2012; 33: 2451-2496

7. Nishimura R, Otto CM, Bonow RO, Carabello BA, Erwin III JP, Guyton RA et al. 2014 AHA/ACC Guidelines for the Management of Patients with Valvular Heart Disease. J Am Coll Cardiol 2014; 63(22): e57-e185

Competing interests: No competing interests

08 December 2016
Martin T. Yates
Specialist Registrar in Cardiothoracic Surgery
Rakesh Uppal, Neil Roberts
Barts Heart Centre
St Bartholomew's Hospital, London, EC1A 7BE