Brief Title
Morbidity and Mortality Due to Deferral of Aortic Valve Replacement in Patients With Severe Aortic Stenosis
Official Title
Morbidity and Mortality Due to Deferral of Aortic Valve Replacement in Patients With Severe Aortic Stenosis - a Collateral Effect of the SARS-CoV-2 Pandemic (AS DEFER)
Brief Summary
Background and Project Rationale:
Degenerative aortic valve stenosis affects 2% of the elderly population aged 70 years or
older and progresses insidiously with advancing age [1] before manifesting with symptoms such
as decreased exercise tolerance, shortness of breath, chest pain and syncope on exertion.
Without aortic valve replacement, the survival prognosis of patients with symptomatic aortic
stenosis is poor. In the PARTNER 1B trial, all-cause mortality among 179 inoperable patients
with severe symptomatic aortic stenosis allocated to conservative management amounted to 51%
at one year [2]. Consistently, prospective registry data reported a mortality rate of 55% at
1 year in 78 patients with severe aortic stenosis undergoing conservative management [3].
The rapid spread of the SARS-CoV-2 pandemic represents an unprecedented challenge for
healthcare systems. A limited number of ventilators and ICU beds call for a careful
allocation of healthcare resources. On March 20 2020, the Federal Council prohibited elective
interventions in all hospitals in Switzerland. Patients with untreated severe aortic stenosis
are particularly vulnerable to SARS-CoV-2 infection [4] and face the dual risk of cardiac
death from aortic stenosis on one side, and death from acute respiratory distress syndrome
secondary to SARS-CoV-2 infection on the other. While the balance between the two risks is a
matter of clinical judgement, the investigators established an algorithm for the management
of patients with severe aortic stenosis during the SARS-CoV-2 pandemic. Patients with aortic
stenosis deemed critical will undergo valvular replacement in spite of the ongoing pandemic
while patients with severe but not critical aortic stenosis will undergo deferred
intervention once the number of new SARS-CoV-2 infections flattens.
In the current situation, aortic valve replacement in patients with severe, non-critical
aortic stenosis will be deferred in order to give priority to SARS-CoV-2 patients. This
unique situation allows the investigators to study the effect of deferral of aortic valve
replacement in patients with severe aortic stenosis.
The study is an amendment to the Swiss-TAVI registry. In contrast to the Swiss-TAVI registry,
patients are not enrolled at the time of aortic valve replacement, but already at the time of
referral for aortic valve replacement.
Primary Objective:
The aim of the present observational study is to explore the effect of deferral of valvular
replacement in patients with severe but not critical aortic stenosis on morbidity and
mortality. The primary objective is to describe rates of morbidity and mortality among
patients with severe but not critical aortic stenosis in the interval from
referral/indication for valvular replacement to intervention.
Project Design:
The study is a prospective cohort study of patients with severe aortic stenosis referred for
aortic valve replacement. All referrals for aortic valve replacement will be allocated to
either "transcatheter aortic valve replacement (TAVR)/ surgical aortic valve replacement
(SAVR) (standard of care)" or "deferred intervention" based on prespecified criteria.
Patients with critical aortic stenosis as defined by an aortic valve area (AVA) <0.6 cm2 or a
transvalvular mean gradient of >60 mmHg or a history of cardiac decompensation during the
previous 3 months or clinical symptoms on minimal exertion (NYHA III) will be allocated to
TAVR or SAVR. All other patients with severe aortic stenosis defined by an AVA <1.0 cm2 will
be scheduled for a deferred intervention.
Study Type
Observational [Patient Registry]
Primary Outcome
Composite of all-cause mortality, disabling and non-disabling stroke, and hospitalization for heart failure
Condition
Aortic Valve Stenosis
Intervention
TAVR or SAVR
Study Arms / Comparison Groups
TAVR/SAVR
Description: Patients with critical aortic stenosis as defined by an AVA <0.6 cm2 or a transvalvular mean gradient of >60 mmHg or a history of cardiac decompensation during the previous 3 months or clinical symptoms on minimal exertion (NYHA III) will be allocated to transcatheter aortic valve replacement or surgical aortic valve replacement.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
71
Start Date
March 20, 2020
Completion Date
December 2020
Primary Completion Date
December 2020
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Patients with severe AS defined by an AVA <1cm2 or AVA indexed to BSA of <0.6 cm2/m2,
including low-flow severe aortic stenosis defined by SVI <35ml/m2.
Exclusion Criteria:
- Life expectancy <1 year irrespective of severe AS.
- Severe dementia defined as MMS-Test <16 points.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Thomas Pilgrim, MD, ,
Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT04333875
Organization ID
2020-00672
Responsible Party
Sponsor
Study Sponsor
University Hospital Inselspital, Berne
Study Sponsor
Thomas Pilgrim, MD, Principal Investigator, University of Bern, Switzerland
Verification Date
May 2020