Health status after transcatheter vs. surgical aortic valve replacement in low-risk patients with aortic stenosis

Selected in Journal of the American College of Cardiology by S. Brugaletta

Although multiple studies have demonstrated an early health status benefit with TAVI vs. SAVR , this is the first randomized trial to demonstrate a persistent, albeit modest, health status advantage with TAVI at 6 and 12 months—timepoints at which patients are assumed to have recovered fully from surgery.

Reviewer

Salvatore Brugaletta

@sbrugaletta

Interventional cardiologist / Cardiologist

Barcelona, Spain

Latest contributions

Optical coherence tomography- vs angiography-guided coronary stent implantation in calcified lesions: the ILUMIEN IV trial Percutaneous coronary treatment with Bioadaptor implant vs drug-eluting stent : 2-year outcomes from BIOADAPTOR RCT Coronary revascularisation deferral based on quantitative flow ratio or fractional flow reserve: a post-hoc analysis of the FAVOR III Europe trial

View full profile

My Comment

Why this study – the rationale/objective?

In patients with severe aortic stenosis (AS) at low surgical risk, treatment with transcatheter aortic valve replacement (TAVI) results in lower rates of death, stroke, and re- hospitalization at 1 year compared with surgical aortic valve replacement; however, the effect of treatment strategy on health status is unknown. This study sought to compare health status outcomes of TAVI vs. surgery in low- risk patients with severe AS.

How was it executed – the methodology?

Between 3/2016 and 10/2017, 1000 low-risk AS patients were randomized to transfemoral TAVR using a balloon-expandable valve or surgery in the PARTNER 3 Trial. Health status was assessed at baseline, 1, 6 and 12 months using the Kansas City Cardiomyopathy Questionnaire (KCCQ), SF-36 and EQ-5D. The primary endpoint was change in KCCQ-Overall Summary (KCCQ-OS) score over time. Longitudinal growth curve modeling was used to compare changes in health status between treatment groups over time.

What is the main result?

At 1 month, TAVI was associated with better health status than surgery (mean difference in KCCQ-OS 16.0 points; p<0.001). At 6 and 12 months, health status remained better with TAVR, although the effect was reduced (mean difference in KCCQ-OS 2.6 and 1.8 points respectively; p<0.04 for both). The proportion of patients with an excellent outcome (alive with KCCQ-OS ≥ 75 and no significant decline from baseline) was greater with TAVR than surgery at 6 months (90.3% vs. 85.3%; p=0.03) and 12 months (87.3% vs. 82.8%; p=0.07).

Critical reading and relevance for clinical practice

This is the first study to evaluate the effects of TAVI and SAVR on health-related quality of life in patients with severe AS at low surgical risk. Although multiple studies have demonstrated an early health status benefit with TAVI vs. SAVR ,this is the first randomized trial to demonstrate a persistent, albeit modest, health status advantage with TAVI at 6 and 12 months—timepoints at which patients are assumed to have recovered fully from surgery.

Two main points should be highlighted in this article.

• The first is that in low-risk patients we would not expect such difference at 6-month, as according to the lower risk of a specific patient we should expect a faster recovery without any difference between TAVI and SAVR; however, the present article shows a faster and with higher quality recovery with TAVI vs. SAVR even at 6-month. We may expect that such difference will not be present after 1-year.
• The second point is that what we see now with low-risk TAVI is the same we have previously seen in the comparison between PCI and CABG. All those procedures less invasive exhibit a faster recovery with high quality of life as compared to those procedure more invasive.

The debate now is open on how much such faster recovery in quality of life should be considered in the decision-making process by the patient and doctors.