New guidelines on aortic valve implantation in risk groups with aortic stenosis shifted from risk strata to a focus on patient age and life expectancy.
The 2020 American College of Cardiology (ACC) and the American Heart Association (AHA) guideline of management of patients with valvular heart diseases has been updated following the results of both randomized clinical trials and regulatory approval of transcatheter aortic valve implantation technology (TAVI) in patients with aortic stenosis.
The team, led by Thoralf M. Sundt, MD, Massachusetts General Hospital, Harvard Medical School, observed how the emphasis on recommendations for surgical aortic valve replacement (SAVR) or TAVI shifted from risk strata to more of a focus on patient age and life expectancy.
They noted the emphasis on engagement of the heart team, as well as the process of shared decision-making.
Data show the results of multiple RCTs have established TAVI as an alternative to SAVR in treatment of aortic stenosis in all risk groups.
The decision in choice of TAVI or SAVR is dependent on patient-specific factors, noted the investigators, as well as the decision between mechanical and biological prostheses.
Some of the factors included technical, procedure-specific contraindications and the balance between estimated life expectancy and anticipated prosthesis durability.
Due to this, SAVR is recommended for the majority of patients ≤65 years, while mechanical valves are favored in patients ≤50 years.
Patients who are >65 years, the guideline noted the perioperative risks of mortality and stroke are lower with transfemoral TAVI compared with SAVR.
However, the risks of paravalvular leak, pacemaker requirement and vascular complications have a higher risk.
Further, TAVI has demonstrated a lower risk of stroke and perioperative death, less major bleeding and shorter length of hospital stay in a meta-analysis of RCTs.
“Data from RCTs and observational studies have demonstrated clearly that TAVI is superior to medical therapy for severe symptomatic aortic stenosis among patients with inoperable cases or at extreme risk,” investigators wrote.
Sundt and colleagues noted the use of TAVI has appeal for older patients with calcific aortic stenosis with a trileaflet valve.
They noted the transcatherter aortic valve implantation has benefit in patients with a heavily calcified ascending aorta and patients with comorbidities including severe lung, liver, or kidney dysfunction.
However, there is inadequate data in recommending TAVI to patients ≤65 years or patients with aortic stenosis secondary to bicuspid aortic valve or rheumatic valve disease.
Further, risks may also be exacerbated by anatomic factors including large or small valve annulus, subaortic calcification, or hypertrophy requiring myectomy or aortic dilatation.
In addition, concomitant conditions such as clinically significant primary mitral regurgitation or coronary artery disease (CAD) are not recommended for TAVI treatment.
The team noted the greatest benefit of TAVI is obtained with the transfemoral approach, so inadequate femoral vascular access is in favor of SAVR.
The team concluded that long-term durability of TAVI will better define its potential in younger patients, as well as showing the long-term outcomes in patients with bicuspid aortic valves.
“Finally, the implications of need for future surgical intervention following TAVI because of patient prosthesis mismatch, structural valve deterioration, infection, or other indications are yet to be defined,” investigators wrote.
The study, “Guideline Update on Indications for Transcatheter Aortic Valve Implantation Based on the 2020 American College of Cardiology/American Heart Association Guidelines for Management of Valvular Heart Disease,” was published online in JAMA Cardiology Clinical Guidelines Synopsis.