Transcatheter or surgical aortic valve replacement for patients with severe, symptomatic, aortic stenosis at low to intermediate surgical risk: a clinical practice guidelineBMJ 2016; 354 doi: https://doi.org/10.1136/bmj.i5085 (Published 28 September 2016) Cite this as: BMJ 2016;354:i5085
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- Per O Vandvik, associate professor1 2,
- Catherine M Otto, professor3,
- Reed A Siemieniuk, methodologist4 5,
- Rodrigo Bagur, assistant clinical professor6,
- Gordon H Guyatt, distinguished professor4 7,
- Lyubov Lytvyn, methodologist8,
- Richard Whitlock, associate professor9 10,
- Trond Vartdal, consultant physician11,
- David Brieger, professor12,
- Bert Aertgeerts, professor13,
- Susanna Price, professor14,
- Farid Foroutan, graduate student4 15,
- Michael Shapiro, community representative and senior health informaticist for RTI International16,
- Ray Mertz, community representative17,
- Frederick A. Spencer, professor4 7
- 1Institute of Health and Society, Faculty of Medicine, University of Oslo, 0318 Oslo, Norway
- 2Department of Medicine, Innlandet Hospital Trust-division, Gjøvik, Norway
- 3Division of Cardiology, Department of Medicine, University of Washington School of Medicine, Seattle, Washington, USA 98195
- 4Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada L8S 4L8
- 5Department of Medicine, University of Toronto, Toronto, Ontario, Canada
- 6Division of Cardiology, London Health Sciences Centre and Department of Epidemiology & Biostatistics, Western University, London, Ontario, Canada N6A 3K7
- 7Department of Medicine, McMaster University, Hamilton, Ontario, Canada L8S 4L8
- 8Systematic Overviews through advancing Research Technology, Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario Canada M5G 0A4
- 9Department of Surgery, McMaster University, Hamilton, Ontario, Canada L8S 4L8
- 10Population Health Research Institute, Hamilton, Ontario, Canada L8L 2X2
- 11Department of Cardiology, Oslo University Hospital – Rikshospitalet, 0424 Oslo, Norway
- 12Concord Repatriation General Hospital, Concord, New South Wales 2139, Australia
- 13Department of Public Health and Primary Care, KU Leuven, 3000 Leuven, Belgium
- 14Royal Brompton Hospital, London SW3 6NP, UK
- 15Heart Failure/Transplant Program, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada M5G 2C4
- 16Chicago, Illinois, USA
- 17London, Ontario, Canada
- Corresponding author: P O Vandvik
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
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 replacement, life expectancy is typically 50% at two years, with escalation of heart failure and reduced quality of life.5 These recommendations are for patients with symptoms and severe aortic stenosis: patients without symptoms or with milder disease are not considered here. Box 1 shows the linked articles in this BMJ Rapid Recommendations cluster.
Box 1: Linked articles in this BMJ Rapid Recommendations cluster
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. doi:10.1136/bmj.i5130
Foroutan F, Guyatt GH, O’Brien K, et al. Prognosis after surgical replacement with a bioprosthetic aortic valve in patients with severe symptomatic aortic stenosis: systematic review of observational studies. BMJ 2016;354:i5065. doi:10.1136/bmj.i5065
Lytvyn L, Guyatt GH, Manja V, et al. Patient values and preferences on transcatheter or surgical aortic valve replacement therapy for aortic stenosis: a systematic review. BMJ Open 2016;6:e014327. doi:10.1136/bmjopen-2016-014327
Editorial: Siemieniuk RA, Macdonald H, Agoritsas T, Guyatt GH, Vandvik PO. Introduction to BMJ Rapid Recommendations. BMJ 2016;354:i5191, doi:10.1136/bmj.i5191.
Magic App (www.magicapp.org/public/guideline/aEeKpL)
Expanded version of the results with multilayered recommendations, evidence summaries, and decision aids for use on all devices
How the recommendations were created
The international expert panel included front line and intervention cardiologists, a heart surgeon, internists, a general practitioner, methodologists, and people with lived experience of the condition (see list of panel members). To avoid bias, we excluded people with a professional, academic, or financial conflict of interest that we judged as excessive (see online methods supplement, competing interests statement, and appendix of interests of the panel members).
The panel followed standards for trustworthy guidelines and used the GRADE methodology to critically appraise the evidence and to create recommendations.6 7 8 When moving from evidence to recommendations, the panel integrated information on benefits and harms of treatment alternatives, quality of evidence, and values and preferences of patients as well as acceptability, feasibility, and resources (see box 1). Estimates of absolute effects are derived from relative effect estimates from the systematic review coupled with the best population estimates of baseline risks derived from a linked systematic review of observational studies.9 We label recommendations for or against each alternative as either weak or strong (see infographic).
A linked systematic review and meta-analysis combines the data from the Partner 2 trial with three other trials (see fig 2⇓). It pools data on 3128 patients with symptomatic severe aortic stenosis at low or moderate risk of perioperative death, typically followed for two years.1 10 11 12 13 14
Compared with SAVR, transfemoral TAVI reduced mortality and stroke, life threatening bleeds, atrial fibrillation, and acute kidney injury at two years, but increased heart failure, major vascular complications, pacemaker insertion, and need for aortic valve reintervention within 2 years (see infographic).10 In contrast, transapical TAVI may increase mortality and stroke compared with the surgical approach. The results for mortality, stroke, and acute kidney injury were based on a subgroup analysis for transfemoral versus transapical approach, deemed credible by the review authors according to specific criteria.15
Estimates of baseline risk for most outcomes came from a linked systematic review on prognosis for patients undergoing SAVR.9
The panel were reasonably confident that the absolute effect sizes for the short term benefit and harm of TAVI and SAVR were true and accurate estimates (that is, overall moderate certainty according to GRADE). But the panel were very uncertain about the long term durability of the valves used in TAVI, particularly with respect to their recommendations in younger patients with a longer predicted life expectancy. The low certainty in the estimated long term re-intervention rate after TAVI of approximately 27 in 100 people reflects an absence of published follow-up studies beyond five years.
The linked systematic review on values and preferences yielded extremely limited evidence to inform the recommendations, particularly their strength.16 There are no studies on patients deciding between TAVI and SAVR, although one study evaluated patient preferences and values when deciding whether to undergo SAVR (versus no surgery).16 17 One study identified multiple biomedical, functional, social, and environmental factors influencing patients’ decisions to undergo assessment for TAVI.18 Overall, there is evidence of variability in individual values and preferences, highlighting the need for shared decision making, particularly for patients aged between 65 and 85 years.
Perioperative risk is typically assessed by expert cardiovascular teams. Validated risk scores such as the STS-PROM are available online (www.riskcalc.sts).
Type of device and TAVI approach may vary: balloon expandable and self expanding devices can be used via transfemoral, subclavian, direct aortic, transcarotid, or transapical (balloon only) routes.
Fig3⇓ lists issues that may influence a person’s choice of procedure. These are further detailed in MAGICapp within the consultation decision aids that provide all desirable and undesirable consequences of treatment options.
Costs and resources
There are no cost effectiveness data for patients at low to intermediate surgical risk considering TAVI versus SAVR. Both procedures are resource demanding and require an experienced cardiovascular team (table 1⇓). In general, TAVI devices are more expensive than surgery, but this extra cost may be partially offset by a slightly shorter hospital stay and less need for post-discharge rehabilitation.
Future recommendations and guidelines would benefit from studies that answer the following questions
Qualitative or survey study. What are the values and preferences of patients deciding between TAVI and SAVR, particularly with respect to uncertain durability of TAVI devices, the desire to avoid open heart surgery, and post-procedure pain and recovery time?
What is the durability of the TAVI valves beyond five years?
How patients were involved in the creation of this article
Two people with lived experience of severe aortic stenosis were full panel members and contributed with their experience and perspectives throughout the Rapid Recommendations process. Initially the community panel members identified pain and recovery time (in addition to already identified outcomes) and practical issues as important for choosing between TAVI and SAVR. They also fully participated in teleconferences and email exchange to discuss the evidence, draft recommendations, and to provide feedback in the creation of this article.
This BMJ Rapid Recommendations article is one of a series that provides clinicians with trustworthy recommendations for potentially practice changing evidence. BMJ Rapid Recommendations represent a collaborative effort between the MAGIC group (www.magicproject.org) and The BMJ. A summary is offered here and the full version including decision aids is on the Magic app (www.magicapp.org), for all devices in multilayered formats. Those reading and using these recommendations should consider individual patient circumstances such as frailty, overall life expectancy, and relevant comorbidity, and their values and preferences. We encourage adaptation of recommendations to allow contextualisation of recommendations and to reduce duplication of work. Those considering use or adaptation of content may go to MAGICapp to link or extract its content or contact The BMJ for permission to reuse content in this article. Series adviser Rafael Perera-Salazar
Competing interests: All authors have completed the BMJ Rapid Recommendations interests form. The BMJ Rapid Recommendations team judged that no panel member declared financial, professional, or academic interests that precluded authorship. The declared interests for each panel member are attached. No panel members declared any financial conflicts of interest related to this clinical question, specifically no financial ties to the heart valve industry. D Brieger receives personal and institutional research funding from industry, none relevant for TAVI or SAVR (has received funding from Eli Lilly, Astra Zeneca, Sanofi Aventis, Boerhinger Ingelheim, Pfizer, Merck Sharp and Dohme, Bristol-Myers Squibb, and Bayer all related to antithrombotic or diabetes therapy). R Whitlock has received funding for consulting with Atricure and Armetheon (both focus on atrial fibrillation management). R Bagur is a primary investigator of a trial on anticoagulation in atrial fibrillation, sponsored by Bristol-Myers Squibb. R Whitlock performs SAVR. R Bagur performs TAVI. CM Otto has co-chaired the American College of Cardiology guidelines on valvular heart disease, which includes TAVI, and is the UpToDate editor on the same topic. R Whitlock is the section lead for the American College of Chest Physicians valve guidelines. S Price is a panel member of the European Cardiology Society guidelines on heart valves. RA Siemieniuk, GH Guyatt, PO Vandvik, CM Otto, R Bagur, F Foroutan, and L Lytvyn participated in writing the complementary systematic reviews that formed the evidence base for this guideline. No panel member has previously formally made statements favouring either option in low or intermediate perioperative risk patients. This article was edited by H MacDonald at The BMJ who had no relevant financial or intellectual interests.