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Edwards SAPIEN 3 Скачать руководство пользователя страница 18

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Table 11:

Secondary Endpoints for Labeling –

SAPIEN 3 Valve vs. SAPIEN Valve (VI Population)

Endpoints

Original

p-value

Inference

Major Vascular

Complications at 30

Days

0.0578

> 0.05; reject the alternative

hypothesis. Proceed to the rest of

testing

AI at 30 Days

0.0051

< 0.025; claim superiority

Adverse Events

The key CEC adjudicated adverse events at 30 days are presented in Table 12.

Table 12:

CEC Adjudicated Adverse Events at 30 Days

(PIIS3HR VI Population)

30 Day Adverse Events

SAPIEN 3 Valve

Overall

SAPIEN 3 Valve

Transfemoral

Access

TF

SAPIEN 3

Valve

Non-

Transfemoral

Access

Composite Event Rate of Death, All Stroke and

AI ≥ Moderate,

n/N (%)

37/545 (6.8 %)

27/463 (5.8 %)

10/82 (12.2 %)

Death

From Any cause,

n/N (%)

13/583 (2.2%)

8/491 (1.6%)

5/92 (5.4%)

From cardiovascular cause,

n/N (%)

8/583 (1.4%)

5/491 (1.0%)

3/92 (3.3%)

Stroke,

n/N (%)

9/583 (1.5%)

8/491 (1.6%)

1/92 (1.1%)

AI ≥ moderate,

n/N (%)

16/532 (3.0%)

12/455 (2.6%)

4 /77 (5.2%)

Myocardial Infarction,

n/N (%)

3/583 (0.5%)

2/491 (0.4%)

1/92 (1.1%)

Major Vascular Complications,

n/N (%)

29/583 (5.0%)

26/491 (5.3%)

3/92 (3.3%)

Acute Kidney Injury, Stage III,

n/N (%)

6/583 (1.0%)

4/491 (0.8%)

2/92 (2.2%)

Disabling Bleeding Event,

n/N (%)

37/583 (6.3%)

27/491 (5.5%)

10/92 (10.9%)

Aortic Valve Re-Intervention,

n/N (%)

6/583 (1.0%)

4/491 (0.8%)

2/92 (2.2%)

Endocarditis,

n/N (%)

1/583 (0.2%)

1/491 (0.2%)

0/92 (0.0%)

Conduction Disturbance Requiring Permanent
Pacemaker,

n/N (%)

76/583 (13.0%)

65/ 491 (13.2%)

11/ 92 (12.0%)

Other Results

Procedural Information

Overall, the mean duration in the catheterization laboratory/hybrid suite was 192.8 ± 59.3 min, the mean
total procedure time was 86.3 ± 44.2 min, and the mean total anesthesia time was 193.7 ± 62.9 min.
These duration times were slightly shorter in the TF patients. General anesthesia was used in the vast
majority of cases; 15.9% of the TF patients had conscious sedation. Correct positioning of the valve was
achieved in 99.1% of the patients. Five patients (0.9%; including 3 TF patients) were implanted with a
second valve. One patient (0.2%) experienced valve embolization following rupture of the delivery balloon
on annular calcium. This patient was converted to surgical aortic valve replacement and later died from
aortic dissection.

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Содержание SAPIEN 3

Страница 1: ...tions for use prior to using the device by visiting http THVIFU edwards com or by calling 1 800 822 9837 In order to access the instructions for use an IFU Code will be required STERILE The valve is s...

Страница 2: ...ng and oversizing should be considered Edwards Commander Delivery System Figure 2 The Edwards Commander delivery system is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve and consi...

Страница 3: ...tions The valve and delivery systems are contraindicated in patients who cannot tolerate an anticoagulation antiplatelet regimen or who have active bacterial endocarditis or other active infections 4...

Страница 4: ...atelet therapy except when contraindicated as determined by their physician This device has not been tested for use without anticoagulation Do not add or apply antibiotics to the storage solution rins...

Страница 5: ...s severe obstructive calcification or severe tortuosity o Bulky calcified aortic valve leaflets in close proximity to coronary ostia 6 0 Potential Adverse Events Potential risks associated with the ov...

Страница 6: ...low cardiac output Coronary flow obstruction transvalvular flow disturbance Device thrombosis requiring intervention Valve thrombosis Device embolization Device migration or malposition requiring int...

Страница 7: ...ge or larger High pressure 3 way stopcock x2 Standard cardiac catheterization lab equipment Fluoroscopy fixed mobile or semi mobile fluoroscopy systems appropriate for use in percutaneous coronary int...

Страница 8: ...and the balloon catheter is fully advanced in the flex catheter WARNING To prevent possible damage to the balloon shaft ensure that the proximal end of the balloon shaft is not subjected to bending 2...

Страница 9: ...pper 9 Gently remove the Qualcrimp crimping accessory from the valve Remove the Qualcrimp Stop from the Final Stop leaving the Final Stop in place 10 Fully crimp the valve until it reaches the Final S...

Страница 10: ...til the valve exits the sheath Retract the loader to the proximal end of the delivery system NOTE Maintain the proper orientation of the flex catheter with the Edwards logo facing up throughout the pr...

Страница 11: ...r tip is locked over the Triple Marker and remove the delivery system from the sheath CAUTION Patient injury could occur if the delivery system is not unflexed prior to removal 2 Remove all devices wh...

Страница 12: ...compare the third generation Edwards SAPIEN 3 valve system with the first generation Edwards SAPIEN valve system in patients who either have high risk for surgery or cannot undergo surgery inoperable...

Страница 13: ...events were adjudicated irrespective of whether there was an identifiable overt source of bleeding An electrocardiogram ECG core laboratory was used for independent analysis of rhythm an echocardiogra...

Страница 14: ...disease COPD no Any 259 44 6 216 44 1 43 47 3 Oxygen dependent 68 11 8 58 11 9 10 11 0 Atrial fibrillation no 255 43 7 212 43 2 43 46 7 Permanent pacemaker no 95 16 3 78 15 9 17 18 5 Severe pulmonary...

Страница 15: ...all cause mortality cardiac mortality and all stroke at 30 days for the SAPIEN 3 cohort and the SAPIEN cohort are provided in Table 8 Table 8 Death and Stroke at 30 Days SAPIEN 3 Valve vs SAPIEN Valv...

Страница 16: ...3 Valve N 583 SAPIEN Valve N 326 Weighted Proportion Difference in Average Treatment Effect on the Treated ATT P value AI Moderate n Total no 95 CI 16 532 3 0 1 7 4 8 1 40 280 14 3 10 4 18 9 1 13 1 2...

Страница 17: ...type two sided 90 confidence interval using weighted mean and SD is provided Table 11 lists the hypothesis testing of the two secondary endpoints conducted with p values in descending order for the Ho...

Страница 18: ...cular Complications n N 29 583 5 0 26 491 5 3 3 92 3 3 Acute Kidney Injury Stage III n N 6 583 1 0 4 491 0 8 2 92 2 2 Disabling Bleeding Event n N 37 583 6 3 27 491 5 5 10 92 10 9 Aortic Valve Re Inte...

Страница 19: ...IIS3HR VI Population The average mean gradient decreased from 45 5 14 3 mmHg at baseline to 11 1 4 5 mmHg at 30 days as shown in Figure 6 Figure 6 Mean Gradient PIIS3HR VI Population Doppler Velocity...

Страница 20: ...proportion of patients with AI moderate was 7 3 at baseline and 3 0 at 30 days as shown in Figure 8 Figure 8 Aortic Insufficiency PIIS3HR VI Population Peak Gradient mmHg 0 10 20 30 40 50 60 70 80 90...

Страница 21: ...l patients the mean NYHA class was 3 2 0 6 at baseline and 1 7 0 7 at 30 days Figure 10 NYHA Class by Visit PIIS3HR VI Population None Trace Mild Mild Moderate Moderate Moderate Severe Severe Percenta...

Страница 22: ...31 8 8 7 at baseline to 37 3 9 8 at 30 days and the mental component score improved from 46 8 13 1 at baseline to 50 5 12 2 at 30 days In the TA TAo patients the physical component score improved from...

Страница 23: ...Overall SAPIEN 3 Valve Transfemoral Access SAPIEN 3 Valve Non Transfemoral Access All Treated AT Population Valve Implant VI Population All Treated AT Population Valve Implant VI Population All Treat...

Страница 24: ...10 5 4 8 9 Severe liver disease Cirrhosis no 1 1 0 1 1 8 0 0 Echocardiographic findings Effective Orifice Area EOA cm 2 0 6 0 2 0 6 0 2 0 6 0 1 Mean aortic valve gradient mmHg 44 8 15 3 45 2 14 7 44 2...

Страница 25: ...Acute Kidney Injury Stage III n N 0 102 0 0 0 57 0 0 0 45 0 0 N A N A N A Disabling Bleeding Event n N 6 102 5 9 3 57 5 3 3 45 6 7 N A N A N A Valve Dysfunction Requiring Intervention n N 0 102 0 0 0...

Страница 26: ...justment The adjusted confidence intervals could be wider than presented here As such confidence intervals are provided to illustrate the variability only and should not be used to draw any statistica...

Страница 27: ...provided to illustrate the variability only and should not be used to draw any statistical conclusion Valve Performance The mean EOA increased from 0 6 0 2 cm 2 at baseline to 1 5 0 4 cm 2 at 30 days...

Страница 28: ...ays and maintained at 21 5 8 2 mmHg at 1 year as shown in Figure 15 Figure 15 Peak Gradient S3OUS VI Population The proportion of patients with aortic insufficiency moderate was 9 8 at baseline 3 7 at...

Страница 29: ...e NYHA class by visit is shown in Figure 18 For all patients the mean NYHA class decreased from 3 0 0 5 at baseline to 1 6 0 7 at 30 days and 1 8 0 6 at 1 year None Trace Mild Mild Moderate Moderate M...

Страница 30: ...surgical valve and constitute the PIIA SAVR VI population Table 16 Patient Accountability All Enrolled Patients Eligible Patient EP Population Valve Implant VI Population SAPIEN 3 Cohort 1078 1074 106...

Страница 31: ...66 4 Previous myocardial infarction 172 1074 16 0 133 948 14 0 39 126 31 0 166 938 17 7 Previous intervention Coronary artery bypass grafting CABG 301 1074 28 0 248 948 26 2 53 126 42 1 241 938 25 7 P...

Страница 32: ...Continuous measures Mean SD Categorical measures n total no Safety and Effectiveness Results Primary Endpoints The primary endpoint was a composite of all cause death stroke and AI moderate at 1 year...

Страница 33: ...Pooled Proportion Difference ATT Method Endpoints Observed Event Rate Kaplan Meier Event Rate Observed Event Rate Kaplan Meier Event Rate Point Estimate Standard Error Point Estimate Standard Error Al...

Страница 34: ...to draw any statistical conclusion Figure 21 All Stroke through 1 Year VI Population Note The confidence intervals were calculated without multiplicity adjustment The adjusted confidence intervals cou...

Страница 35: ...espective non inferiority margin Therefore for each of the secondary endpoints for labeling the SAPIEN 3 valve was non inferior to SAVR Table 21 Secondary Endpoints for Labeling Gatekeeping Hierarchic...

Страница 36: ...ing a hierarchical gatekeeping approach The confidence interval shown here was not adjusted for multiplicity per the gatekeeping approach Adverse Events The key CEC adjudicated adverse events through...

Страница 37: ...948 0 6 0 126 0 0 4 938 0 4 Any endocarditis 8 1074 0 7 7 948 0 7 1 126 0 8 6 938 0 6 Categorical measures n total no In addition site reported new onset atrial fibrillation was 5 9 in the PIIS3i EP p...

Страница 38: ...esented in Figures 24 28 The increase in EOA and decrease in gradient were sustained at 1 year In PIIS3i the proportion of patients with total AR moderate was 6 2 at baseline 3 9 at 30 days and 1 6 at...

Страница 39: ...39 Figure 26 Peak Gradient VI Population Figure 27 Total Aortic Regurgitation VI Population Figure 28 Aortic Paravalvular Leak VI Population...

Страница 40: ...ere in NYHA Class III or IV at baseline which reduced to 6 3 at 30 days and 6 7 at 1 year while in PIIA SAVR the percentage of patients in NYHA Class III or IV was 76 0 at baseline 13 6 at 30 days and...

Страница 41: ...tion Six Minute Walk Test 6MWT The improvements in mean 6MWT distance are presented in Table 24 As compared to the SAPIEN 3 patients the PIIA SAVR patients had a decrease in mean 6MWT distance from ba...

Страница 42: ...7 11 9 7 6 ICU 2 7 3 0 2 5 2 6 4 2 4 9 5 6 6 1 Plus minus values are means SD Quality of Life QoL The QoL measurements using the Kansas City Cardiomyopathy Questionnaire KCCQ clinical summary score ar...

Страница 43: ...43 Figure 32 KCCQ Clinical Summary Score TF versus non TF Access EP Population...

Страница 44: ...le 27 SF 36 Health Status Questionnaire Score EP Population SF 36 Health Status Questionnaire Score SAPIEN 3 Valve PIIA SAVR All TF Non TF Physical Component Score Baseline 34 7 9 1 35 0 9 1 33 1 8 5...

Страница 45: ...45...

Страница 46: ...Copyright 2016 Edwards Lifesciences LLC All rights reserved Web IFU 10001354002 A Manufacturer Edwards Lifesciences LLC Telephone 949 250 2500 One Edwards Way 800 424 3278 Irvine CA 92614 USA FAX 949...

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