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How can TAVI benefit your low-risk patients with severe aortic stenosis (sAS) now and in the future?
Supported by proven results from PARTNER 3,1 low-risk patients with sAS now have the opportunity for TAVI. As these patients are usually younger and healthier than those in higher risk categories,1-6 further considerations for this group include valve durability and valve-in-valve (ViV) procedures that support their longer-term management.
Now you can give your low-risk AS patients a chance at the lowest-risk option
- TAVI offers the low-risk indication and proven superiority* over surgery (sAVR)
Low risk patients are younger and healthier and, for them, sAS is their primary concern
Low-risk patients are healthier1
Low-risk patients are younger1
Low-risk patients have fewer comorbidities
Baseline patient characteristics of AS treated populations
CABG, coronary artery bypass grafting; CAD, coronary artery disease; COPD, chronic obstructive pulmonary disease; KCCQ, Kansas City Cardiomyopathy Questionnaire; NYHA, New York Heart Association; PPM, permanent pacemaker; STS, Society of Thoracic Surgeons.
- With the low-risk indication and proven superiority over sAVR* nothing stands in the way of a TAVI evaluation for your patients1
Only SAPIEN 3 TAVI was proven superior to surgery on the primary endpoints (all-cause death, all-stroke, or rehospitalisation)1,7
PARTNER 3 Low-Risk Trial
Primary Endpoint: Baseline Death, Stroke or Rehospitalisation
Change from baseline in KCCQ-OS score at 1 month, 6 months and 1 year with SAPIEN 3 TAVI4
PARTNER 3 Low-Risk Trial
Primary Endpoint: Baseline Death, Stroke or Rehospitalisation
KCCQ-OS, Kansas City Cardiomyopathy Questionnaire–Overall Summary.
- With half-a-million transcatheter heart valve implants and 18 years of experience, TAVI has evolved to deliver faster procedures, shorter hospital stays, less rehospitalisation, and low pacemaker rates1
- Additionally, SAPIEN 3 TAVI has demonstrated substantially improved early and sustained QoL benefits in low-risk patients with sAS at 1 month, 6 months and 1 year compared with sAVR†4
Proven to be superior to surgery on primary end points in PARTNER 3, refer your low-risk patients with sAS for TAVI evaluation
See the dataValve durability and future treatment options are a key consideration in low-risk patients with sAS and longer life expectancies8-10
Especially in younger and healthier AS patients, valve durability and future treatment options should be considered.
- 5 year-data from PARTNER 2S3i shows long-term durability with SAPIEN 3 TAVI is equivalent to surgery, with:11
- Sustained improvements in haemodynamic performance‡
- Similar rates of reintervention for TAVI vs sAVR§
- Similar rates of haemodynamic valve deterioration (HVD) and bioprosthetic valve failure (BVF) for TAVI vs sAVR
Keep your low-risk patients active with a TAVI that is supported by real-world durability data
- ViV is a viable alternative to redo (reoperative) surgery for degenerate sAVR or TAVI10
- Compared with redo surgery, ViV TAVI is associated with:12
- Shorter stays in ICU
- Reduced time on ventilation
- Lower transfusion requirements
- ViV TAVI is associated with lower early mortality and morbidity, and increased survival at 5 years compared with redo (reoperative) surgery13
No matter what their future brings, know they have the option of ViV TAVI
* The PARTNER 3 Trial proved SAPIEN 3 TAVI is superior to surgery for the primary endpoint and multiple pre-specified secondary endpoints.1
† 1 month = 16.0 points; 95% CI 14.2 to 17.8; p<0.001. 6 months = 2.6 points; 95% CI 1.0 to 4.3; p=0.002. 1 year = 1.8 points; 95% CI 0.1 to 3.5; p=0.033.4
‡ 45.9mmHg at baseline, 11.6mmHg at 1 Year, 11.6mmHg at 3 Years and 11.2mmHg at 5 Years. 11
§ 1.3% vs 0.8% for TAVI and sAVR, respectively. Odds ratio 0.60 (95% CI, 0.22-1.65; p = 0.31)11
¶ 0.63% vs 0.60% for rate of Stage 2 and 3 for TAVI and sAVR, respectively; p = 0.86. Stage 2 & 3 HVD defined as: +Δ mean gradient ≥ 10 mmHg and -Δ AVA ≥ 0.3 cm2 or ≥ 25%, -Δ DVI ≥ 0.1 or ≥ 20%, AND/OR ≥ 1 grade Δ transvalvular AR with final grade ≥ moderate.11
# 0.63% vs 0.37% for TAVI and sAVR, respectively; p = 0.22. Bioprosthetic valve failure defined as: Re-intervention or death related to valve dysfunction, or severe (Stage 3) structural valve deterioration-related HVD11
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View all articlesReferences:
1 Mack MJ, et al. N Engl J Med. 2019;380(18):1695—1705 and supplementary material.
2 Leon MB, et al. N Engl J Med 2016;374:1609—1620 and supplementary material.
3 Smith CR et al. N Engl J Med 2011;364:2187—2198 and supplementary material.
4 Baron SJ, et al. J Am Coll Cardiol. 2019;74(23):2833—2842.
5 Baron SJ, et al. JACC Cardiovascr Interv. 2018;11(12):1188—1198.
6 Reynolds MR, et al. J Am Coll Cardiol 2012;60(6):548—558.
7 Leon MB & Mack MJ. PARTNER 3: Transcatheter or Surgical Aortic Valve Replacement in Low Risk Patients with Aortic Stenosis. Presented at: American College of Cardiology Annual Scientific Session (ACC 2019), New Orleans, LA, March 17, 2019.
8 Rodriquez-Gabella T, et al. J Am Coll Cardiol. 2017;70(8):1013—1028.
9 Kuck K, et al. Cardiologist 2020;14: 182—204.
10
Sathananthan J, et al. Catheter Cardiovasc Interv. 2021;97(3):E431—E437.
11 Kodali SK, et al. Presentation at the Transcatheter Valve Therapies (TVT) Summit virtual event: TVT Connect 2020. Available at:
https://www.tctmd.com/slide/sapien-3-transcatheter-aortic-valve-replacement-compared-surgery-intermediate-risk-patients-0 (accessed March 2021).
12 Silaschi M et al. Interactive Cardiovasc Thorac Surg. 2017;24(1):63—70.
13 Tam DY, et al. JACC Cardiovasc Interv. 2020;13(6):765—774.
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