Aortic stenosis

Aortic stenosis means the valve between the heart and the main artery to the body is too narrow, so the heart must put in more effort to move blood through. MedlinePlus calls it a common kind of valve narrowing. Age is a listed risk factor for valve disease, and some people are born with an aortic valve that has two flaps instead of three. Treatment can include replacing the valve, by open-heart surgery or through a catheter.

Also called Aortic valve stenosis · Narrowed aortic valve

Condition
In this atlas

Overview

Technical summary

Aortic valve stenosis, MeSH D001024. NHLBI defines stenosis as a valve opening that is too narrow and gives the bicuspid aortic valve as an example; MedlinePlus says aortic valve stenosis is a common type of stenosis. FDA approval orders for the transcatheter valves in this atlas describe the use as easing aortic stenosis in people with heart disease with symptoms caused by severe calcific narrowing of the person's own (native) aortic valve. Trials in this atlas: PARTNER 3 and the Evolut Low Risk trial (low surgical risk), EARLY TAVR (severe stenosis without symptoms) and an earlier trial in people who could not have surgery (see the TAVR record).

Recognition

NHLBI says a doctor may diagnose a valve problem from symptoms, by listening to the heart or with imaging tests.

Burden

No burden claims are published.

Claims and evidence

No claims are published for this condition yet.

Clinical links

Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.

Claim, not a settled fact Evaluated for this: Transcatheter aortic valve replacement (TAVR) (Evaluated for, seen from the other side)
Applies to Recipient not specified
- Patients with severe aortic stenosis whom surgeons considered not to be suitable candidates for surgery; 358 were randomized at 21 centers, 17 of them in the United States. The abstract gives no age range. No registry record was fetched for this trial (the abstract prints NCT00530894).
- 21 centers, 17 of them in the United States (abstract)
- United States and other countries (the abstract gives 17 of 21 centers in the United States)
- Not stated in the abstract
- Gestational age Not reported
- Postnatal age Not reported
Follow-up Outcomes at 30 days and at 1 year (abstract).
In a 2010 trial, 358 patients with severe aortic stenosis whom surgeons considered not suitable for surgery were randomized at 21 centers to standard therapy (including balloon aortic valvuloplasty) or to transfemoral implantation of a balloon-expandable valve (TAVI). At 1 year the rate of death from any cause was 30.7% with TAVI and 50.7% with standard therapy (hazard ratio 0.55, 95% confidence interval 0.40 to 0.74). The rate of death or repeat hospitalization was 42.5% with TAVI and 71.6% with standard therapy (hazard ratio 0.46, 95% confidence interval 0.35 to 0.59). Among survivors at 1 year, 25.2% of the TAVI group and 58.0% of the standard therapy group had cardiac symptoms of New York Heart Association class III or IV.
Limitations. Funded by Edwards Lifesciences. The group studied could not have surgery, so the result does not compare TAVR with surgery. The paper is from 2010, and this record does not say how its valve and delivery system compare with those in the later trials. The harms in the same trial are in a separate claim and should be read with this one. Only the abstract was read; no registry record for this trial was fetched.
Claim, not a settled fact Evaluated for this: Transcatheter aortic valve replacement (TAVR) (Evaluated for, seen from the other side)
Applies to Recipient not specified
- Patients with severe aortic stenosis whom surgeons considered not to be suitable candidates for surgery; 358 were randomized at 21 centers, 17 of them in the United States. The abstract gives no age range. No registry record was fetched for this trial (the abstract prints NCT00530894).
- 21 centers, 17 of them in the United States (abstract)
- United States and other countries (the abstract gives 17 of 21 centers in the United States)
- Not stated in the abstract
- Gestational age Not reported
- Postnatal age Not reported
Follow-up Outcomes at 30 days and at 1 year (abstract).
In the same 2010 trial, at 30 days TAVI was associated with a higher incidence of major strokes (5.0% versus 1.1% with standard therapy, P = 0.06) and major vascular complications (16.2% versus 1.1%, P < 0.001). The authors conclude that TAVI reduced death and symptoms despite the higher incidence of major strokes and major vascular events.
Limitations. The stroke difference has P = 0.06 in the abstract. These harms are as important to the TAVR decision in this group as the lower death rate. This record does not say how the valve and delivery system compare with those in the later trials. Only the abstract was read.
Claim, not a settled fact Evaluated for this: Transcatheter aortic valve replacement (TAVR) (Evaluated for, seen from the other side)
Applies to Recipient not specified
- Patients with severe aortic stenosis and low surgical risk, 1000 of whom were randomized at 71 centers. The abstract gives a mean age of 73 years and a mean Society of Thoracic Surgeons risk score of 1.9%. The registry lists no minimum or maximum age. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.
- 71 centers (abstract). The registry lists sites in the United States, Australia, Canada, Japan and New Zealand.
- United States, Australia, Canada, Japan and New Zealand (registry locations)
- Mean age 73 years (abstract); the registry lists no age limits
- Gestational age Not reported
- Postnatal age Not reported
Follow-up The primary end point was at 1 year; 30-day outcomes are also reported (abstract). The registry gives an estimated study completion of 2029-12.
In PARTNER 3, 1000 patients with severe aortic stenosis and low surgical risk were randomized at 71 centers to TAVR with a balloon-expandable valve placed through the femoral artery, or to surgery. At 1 year, 8.5% of the TAVR group and 15.1% of the surgery group had died, had a stroke or had been hospitalized again (an absolute difference of -6.6 percentage points, 95% confidence interval -10.8 to -2.5; hazard ratio 0.54, 95% confidence interval 0.37 to 0.79). The authors tested both whether TAVR was no worse than surgery (margin 6 percentage points) and whether it was better, and report P<0.001 for noninferiority and P = 0.001 for superiority in the as-treated population. At 30 days TAVR had lower rates of stroke, of death or stroke, and of new atrial fibrillation. The abstract also reports a shorter index hospitalization with TAVR, without tying it to a time point. It reports no significant differences in major vascular complications, new permanent pacemaker insertions or moderate or severe paravalvular regurgitation.
Limitations. Funded by Edwards Lifesciences; the registry lists Edwards Lifesciences as lead sponsor and FDA lists Edwards Lifesciences, LLC as applicant for the valve. The registry lists no masking. The abstract gives the 1-year result of the composite only and no separate counts for death, stroke and rehospitalization, so this record cannot say which part drove the difference. Results are for one valve (SAPIEN 3) placed through the femoral artery in selected low-risk patients. They do not extend to patients at higher risk, to other valves or to other ways of placing the valve. Longer follow-up is not read here. Only the abstract was read: the NEJM page returned HTTP 403, and PubMed lists no open full text.
Claim, not a settled fact Evaluated for this: Transcatheter aortic valve replacement (TAVR) (Evaluated for, seen from the other side)
Applies to Adult
- Patients 65 years or older (registry minimum age) with asymptomatic severe aortic stenosis, 901 of whom were randomized at 75 centers in the United States and Canada. The abstract gives a mean age of 75.8 years, a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 1.8% and 83.6% of patients at low surgical risk. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.
- 75 centers in the United States and Canada (abstract)
- United States and Canada
- Registry minimum age 65 years; mean age 75.8 years (abstract)
Follow-up Median follow-up 3.8 years (abstract). The registry gives the primary completion as 2024-03-31 and an estimated study completion of 2032-03.
In EARLY TAVR, 901 patients with severe aortic stenosis and no symptoms were randomized to early TAVR with a balloon-expandable valve (455 patients) or to clinical surveillance (446 patients). A primary event (death, stroke or unplanned hospitalization for cardiovascular causes) occurred in 122 patients (26.8%) in the TAVR group and 202 (45.3%) in the surveillance group (hazard ratio 0.50, 95% confidence interval 0.40 to 0.63). Death occurred in 8.4% versus 9.2%. Strokes were 4.2% versus 6.7% and unplanned hospitalizations 20.9% versus 41.7%, in the TAVR and surveillance groups respectively. During a median follow-up of 3.8 years, 87.0% of the surveillance group had their aortic valve replaced.
Limitations. Funded by Edwards Lifesciences, which the registry lists as lead sponsor. The registry lists no masking. Death occurred in 8.4% and 9.2% of the two groups, and the abstract gives no test for the individual components, so this record does not say whether the differences in death or stroke are meaningful. Most patients in the surveillance group (87.0%) later had their valve replaced, so the comparison is early replacement with a strategy after which most patients still had replacement. The percentages are not tied to a time point in the abstract. Only the abstract was read. The registry has no posted results yet.

Record details

Record id: cardio:aortic-stenosis
Content hash: 8ca4157fef37e38a69cc715e58a97b88ce62244954cc7a5fd2f1f027afeb759d