Thorac Cardiovasc Surg 2020; 68(S 01): S1-S72
DOI: 10.1055/s-0040-1705299
Oral Presentations
Sunday, March 1st, 2020
Heart Valve Disease
Georg Thieme Verlag KG Stuttgart · New York

Beyond Industry Sponsored Trials—Severe, Symptomatic Aortic Stenosis and Low–Surgical Risk

J. Büch
1   Munich, Germany
,
C. Müller
1   Munich, Germany
,
S. Saha
1   Munich, Germany
,
T. Fabry
1   Munich, Germany
,
M. Lühr
1   Munich, Germany
,
D. Joskowiak
1   Munich, Germany
,
G. Juchem
1   Munich, Germany
,
C. Hagl
1   Munich, Germany
,
M. Pichlmaier
1   Munich, Germany
,
S. Peterss
1   Munich, Germany
› Author Affiliations
Further Information

Publication History

Publication Date:
13 February 2020 (online)

Objectives: Industry sponsored prospective trials, such as PARTNER 3 and evolute low-risk trial have already changed the treatment of patients with severe aortic valve stenosis (AS) and low surgical risk. However, the validity and applicability of the data to typical everyday patient cohorts in high-volume centers is clearly debatable. Here, our institutional results are presented in the light of both studies.

Methods: Between January 2016 and December 2018, 385 consecutive patients with isolated severe AS underwent surgical aortic valve replacement (SAVR) at our institution. Baseline data were gathered during the hospital stay and risk of mortality was evaluated by STS-predicted risk of mortality (PROM). Follow-up data were gathered in September 2019. Patients suffering from aortic regurgitation or endocarditis were excluded.

Results: The mean age was 67.4 ± 9.50 years. Age was 65, 66 to 75 and > 75 years in 35, 46, and 19%, respectively. Mean STS-PROM was 1.1 ± 0.52 and only 5% yielded a score > 2. Stroke rate was 1.4% and a pacemaker was required in 4.7%. Operative mortality was 0.3%. During follow-up, 7.4% were readmitted to the hospital due to various causes, but only 2.8% of cardiac origin. New onset atrial fibrillation occurred in 2.2%. A 30-day mortality was 0.3% and 1-year mortality was 1.6%. Comparison to the recent prospective trial is depicted in [Table 1].

Table 1

Comparison to the recent prospective trial

SAVR

TAVI–PARTNER3

SAVR–PARTNER3

TAVI–EVOLUT

SAVR–EVOLUT

STS

1.1 ± 0.5

1.9 ± 0.7

1.9 ± 0.6

1.9 ± 0.7

1.9 ± 0.7

Age (y)

67.4 ± 10.0

73.3 ± 5.8

73.6 ± 6.1

74.1 ± 5.8

73.6 ± 5.9

30-day mortality (%)

0.3

0.4

1.1

0.5

1.3

1-year mortality (%)

1.6

1.0

2.5

2.4

3.0

stroke

1.4

1.2

3.1

4.1

4.3

Rehospitalization (any/cardiac cause; %)

7.4/2.8

7.3/–

11.0/–

–/3.6

–/6.7

Conclusion: The presented results of SAVR in low-risk patients are superior to those delineated by the commercially driven trials. A more differentiated approach to the so called “low-risk” patient requiring aortic valve treatment for stenosis is therefore required. Long term results will furthermore have to be examined in detail depending on patients’ characteristics. PARTNER 3 and EVOLUT LR should be interpreted with due respect and not lead to frivolous oversimplification of treatment paths.