SAPIEN 3 TAVI is now approved for use in patients with severe aortic stenosis, independent of surgical risk.
With proven superiority to surgery,*1,2 SAPIEN 3 TAVI is establishing a new standard for the treatment of your severe aortic stenosis patients.
PARTNER 3 Trial demonstrates Edwards TAVI is superior to surgery.
At 1 year, SAPIEN 3 TAVI demonstrated 3x lower risk for composite of death or disabling stroke compared to surgery.
Superior to surgery for the outcomes that matter most.*1,2
|Composite Primary Endpoint (death, stroke, rehospitalization)||4.2%||9.3%||p=0.002³|
|All - cause Death||0.4%||1.1%||p=0.21³|
|Major Vascular Complications||2.2%||1.5%||p=0.45|
|Rehospitalization Due to Heart Failure³||0.2%||0.9%||p=0.15|
|New Onset Atrial Fibrillation||5.0%||39.5%||p<0.001|
|Life-threatening, Disabling, or Major Bleeding||3.6%||24.5%||p<0.001|
|New Permanent Pacemaker||6.5%||4.0%||p=0.09³|
|Discharged to Home/Self-care||95.8%||73.1%||p<0.001³|
|Median Length of Hospitalization||3 days||7 days||p<0.001|
TAVI outcomes at 30 days:
96% Discharged to home³
3 days Hospital stay
|Composite Primary Endpoint (death, stroke, rehospitalization)||8.5%||15.1%||p=0.001|
|All - cause Death||1.0%||2.5%||p=0.09|
|Major Vascular Complications||2.8%||1.5%||p=0.19|
|Rehospitalization Due to Heart Failure³||1.4%||3.6%||p=0.03|
|New Onset Atrial Fibrillation||7.0%||40.9%||p<0.01|
|Life-threatening, Disabling, or Major Bleeding||7.7%||25.9%||p<0.001|
|New Permanent Pacemaker||7.3%||5.4%||p=0.21|
|Discharged to Home/Self-care||-||-||-|
|Median Length of Hospitalization||-||-||-|
TAVI outcomes at 1 year:
1.4% Rehospitalization due to heart failure³
7.3% New pacemaker
You can now treat your patients with SAPIEN 3 TAVI, independent of their surgical risk.
|AS Disease Progression||Severe AS, symptoms include decreased exercise tolerance||Severe AS, symptoms include fatigue, dyspnea upon exertion||Severe AS, symptoms include reduced mobility and inability to walk short distances|
|Age/Gender||73-year-old female||81-year-old male||88-year-old female|
|Frailty Indicatiors||0||Passed 3 out of 4 with exception of grip test||Failed 4/4|
|Surgical Risk Score (STS)||2%||6%||10%|
|Comorbidities||None||Diabetes. High blood pressure. Previous PCI. No other comorbidities.||Oxygen-dependent chronic obstructive pulmonary disease, hypertensions, and previous pacemaker implantation due to sick sinus syndrome.|
|QoL Expectations||Retired nurse who enjoys frequent travel, working out, and bike rides. She looks forward to an extended life expectancy due to her age and active lifestyle.||Semi-retired executive for an insurance company. Enjoys walking trails around his home and playing with his grandkids.||Retired teacher, and requires assistance in daily life activities.|
|Low surgical risk||Intermediate surgical risk||High surgical risk|
|TAVI Patient||TAVI Patient||TAVI Patient|
With more than a decade of evidence in randomised clinical trials, TAVI with the SAPIEN 3 System is now approved for use in patients with severe aortic stenosis, independent of surgical risk.
Give your low-risk patients the lowest risk procedure.