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4 

 

2.0  Indications 

The Edwards SAPIEN XT transcatheter heart valve, model 9300TFX, and accessories are indicated for 
relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic 
stenosis who are judged by a Heart Team, including a cardiac surgeon, to be at intermediate or greater 
risk for open surgical therapy 

(i.e., predicted risk of surgical mortality ≥ 3% at 30 days, based on the 

Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS 
risk calculator). 

The Edwards SAPIEN XT transcatheter heart valve and accessories are also indicated for patients with 
symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic 
aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for 

open surgical therapy (i.e., STS operative risk score ≥8% or at a ≥15% risk of mortality at 30 days). 

3.0  Contraindications 

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. 

4.0  Warnings 

•

  Observation of the pacing lead throughout the procedure is essential to avoid the potential risk of 

pacing lead perforation. 

•

  There may be an increased risk of stroke in transcatheter aortic valve replacement procedures, as 

compared to balloon aortic valvuloplasty or other standard treatments in high or greater risk patients. 

•

  The devices are designed, intended, and distributed for single use only. 

Do not resterilize or reuse 

the devices. 

There are no data to support the sterility, nonpyrogenicity, and functionality of the 

devices after reprocessing. 

•

  Care should be exercised when sizing the native annulus or surgical valve; implanting a valve that is 

too small may lead to paravalvular leak, migration or embolization, whereas implanting a valve that is 
too large may lead to residual gradient (patient-prosthesis mismatch) or annular rupture. 

•

  Accelerated deterioration of the valve may occur in patients with an altered calcium metabolism. 

•

  Prior to delivery, the valve must remain hydrated at all times and cannot be exposed to solutions 

other than its shipping storage solution and sterile physiologic rinsing solution. Valve leaflets 
mishandled or damaged during any part of the procedure will require replacement of the valve. 

•

  Caution should be exercised in implanting a valve in patients with clinically significant coronary artery 

disease. 

•

  Patients with pre-existing mitral valve devices should be carefully assessed prior to implantation of 

the valve to ensure proper valve positioning and deployment. 

•

  Do not use the valve if the tamper evident seal is broken, the storage solution does not completely 

cover the valve, the temperature indicator has been activated, the valve is damaged, or the 
expiration date has elapsed. 

•

  Do not mishandle the N delivery system or use it if the packaging or any components are 

not sterile, have been opened or are damaged (e.g. kinked or stretched), or the expiration date has 
elapsed. 

•

  Use of excessive contrast media may lead to renal failure. Measure the patient’s creatinine level 

prior to the procedure. Contrast media usage should be monitored. 

•

  Patient injury could occur if the delivery system is not un-flexed prior to removal. 

•

  Care should be exercised in patients with hypersensitivities to cobalt, nickel, chromium, 

molybdenum, titanium, manganese, silicon, and/or polymeric materials. 

•

  The procedure should be conducted under fluoroscopic guidance. Some fluoroscopically guided 

procedures are associated with a risk of radiation injury to the skin. These injuries may be painful, 
disfiguring, and long-lasting. 

•

  Valve recipients should be maintained on anticoagulant/antiplatelet therapy, except when 

Содержание SAPIEN XT

Страница 1: ...r 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 supplied sterilized...

Страница 2: ...e considered during valve size selection Note Risks associated with undersizing and oversizing should be considered For transcatheter valve in surgical valve procedures size recommendations for surgic...

Страница 3: ...tension tube is supplied for use with the delivery system during inflation Table 4 Model Nominal Balloon Diameter Nominal Inflation Volume Rated Burst Pressure RBP 9355AS23 23 mm 16 mL 7 atm 9355AS26...

Страница 4: ...prosthesis mismatch or annular rupture Accelerated deterioration of the valve may occur in patients with an altered calcium metabolism Prior to delivery the valve must remain hydrated at all times and...

Страница 5: ...and effectiveness have not been established for patients with the following characteristics comorbidities o Non calcified aortic annulus o Severe ventricular dysfunction with ejection fraction 20 o C...

Страница 6: ...overall procedure including potential access complications associated with standard cardiac catheterization balloon valvuloplasty the potential risks of conscious sedation and or general anesthesia an...

Страница 7: ...obstruction transvalvular flow disturbance Device thrombosis requiring intervention Valve thrombosis Device embolization Device migration or malposition requiring intervention Valve deployment in unin...

Страница 8: ...ncludes the Crimp Stopper Additional Equipment 20 cc syringe or larger x2 50 cc syringe or larger Standard cardiac catheterization lab equipment Fluoroscopy fixed mobile or semi mobile fluoroscopy sys...

Страница 9: ...ing in the rinse solution Direct contact between the identification tag and valve is also to be avoided during the rinse procedure No other objects should be placed in the rinse bowls The valve should...

Страница 10: ...tal end away from the pusher Ensure that the valve is aligned between the radiopaque markers 5 Place the valve balloon assembly in crimper aperture and gradually crimp Periodically open crimper to ver...

Страница 11: ...29 mm 6 0 cm Administer heparin to maintain the ACT at 250 sec CAUTION Contrast media use should be monitored to reduce the risk of renal injury 7 3 1 Baseline Parameters Step Procedure 1 Perform an a...

Страница 12: ...evice is empty to ensure complete inflation of the balloon When the balloon catheter has been completely deflated turn off the pacemaker Retract the delivery system into the introducer sheath 7 Diseng...

Страница 13: ...o request an Explant Kit Used delivery system may be disposed of in the same manner that hospital waste and biohazardous materials are handled There are no special risks related to the disposal of the...

Страница 14: ...e SAPIEN XT valve implanted into a failing surgical prosthesis The TF approach was used in 23 patients and the TA TAo approach was used in 34 patients The implanted valve size was 23 mm in 38 patients...

Страница 15: ...Table 13 The mean age was 78 5 years and 60 4 were male A high proportion of patients had significant comorbidities frailty and prior cardiac interventions The mean STS score was 9 7 and 95 4 of all...

Страница 16: ...s shown in Figure 17 The mean KCCQ summary score among the Attempted Implant population improved from 45 5 21 8 at baseline to 68 0 22 0 at 30 days and 70 4 at 1 year Device success was defined as suc...

Страница 17: ...m 2 0 7 0 19 Mean aortic valve gradient mmHg 41 2 12 17 Mean LVEF 52 5 13 37 Moderate or severe mitral regurgitation no total no 70 232 30 2 Plus minus values are mean SD To convert the value for crea...

Страница 18: ...ritical area or organ such as intracranial intraspinal intraocular or pericardial necessitating pericardiocentesis or intramuscular with compartment syndrome OR bleeding causing hypovolemic shock or s...

Страница 19: ...e Hospitalization to 30 Days NR1 NR4 and NR6 TA TAo AT Population 0 10 20 30 40 50 60 70 0 5 10 15 20 25 30 All Cause Mortality or Major Stroke or Rehospitalization Days Post Procedure SAPIEN XT 11 8...

Страница 20: ...30 All Cause Mortality Days Post Procedure SAPIEN XT 8 0 No at Risk SAPIEN XT 265 254 251 250 248 247 241 Figure 5 Major Stroke at 30 Days NR1 NR4 and NR6 TA TAo AT Population 0 5 10 15 20 0 5 10 15...

Страница 21: ...5 20 25 30 Rehospitalization Days Post Procedure SAPIEN XT 3 2 No at Risk SAPIEN XT 265 254 251 248 243 242 236 Figure 7 Effective Orifice Area NR1 NR4 and NR6 TA TAo Valve Implant Population 0 7 1 6...

Страница 22: ...on 41 2 8 6 0 10 20 30 40 50 60 Baseline 30 Days Gradient mmHg SAPIEN XT No of Echos SAPIEN XT 244 200 Table 9 NYHA Functional Class By Visit for NR1 NR4 and NR6 AT Population SAPIEN XT Valve N 265 Vi...

Страница 23: ...4 37 0 10 1 38 8 58 1 19 4 31 3 4 8 0 20 40 60 80 100 Percent I II III IV Baseline TA TAo 227 30 Days TA TAo 227 Figure 10 KCCQ Clinical Summary Score NR1 NR4 and NR6 TA TAo AT Population 50 0 56 6 0...

Страница 24: ...cified aorta no total no 71 1684 4 2 103 995 10 4 Chest wall deformity no total no 18 1684 1 1 6 995 0 6 Liver disease no total no 52 1685 3 1 27 995 2 7 Echocardiographic findings Aortic valve area c...

Страница 25: ...nosis or complications of the valve procedure e g TAVR c Disabling bleeding Fatal bleeding OR bleeding in a critical area or organ such as intracranial intraspinal intraocular or pericardial necessita...

Страница 26: ...maker 51 197 25 9 Pulmonary hypertension 26 197 13 2 Frailty 3 65 197 33 0 Extensively calcified aorta 12 197 6 1 Chest wall deformity 4 197 2 0 Liver disease 14 197 7 1 Reason for Valve Replacement M...

Страница 27: ...5 23 4 27 71 38 0 26 8 50 3 All Cause Mortality 8 195 4 1 1 8 7 9 19 96 19 8 12 4 29 2 All Stroke 5 195 2 6 0 8 5 9 3 96 3 1 0 6 8 9 Moderate or Severe Obstruction 2 12 169 7 1 3 7 12 1 6 54 11 1 4 2...

Страница 28: ...ed as an increase in serum creatinine to 300 3 x increase compared with baseline or serum creatinine of 4 mg d 354 mol L with an acute increase of at least 0 5 mg dl 44 mol L within 72 hours of the pr...

Страница 29: ...n Meier estimates used the first event per patient Events occurring after day 30 and day 365 were not included in the analysis of the 30 day and 1 year results respectively 3 Confidence intervals calc...

Страница 30: ...2 9 09 51 26 7 10 04 16 Total Aortic Regurgitation no total no All Valve Sizes None 22 174 12 6 74 164 45 1 86 163 52 8 34 53 64 2 Trace 34 174 19 5 64 164 39 0 58 163 35 6 15 53 28 3 Mild 42 174 24 1...

Страница 31: ...6 8 6 7 114 6 1 2 37 5 4 Moderate 2 121 1 7 3 116 2 6 2 114 1 8 0 37 0 0 Severe 2 121 1 7 1 116 0 9 1 114 0 9 0 37 0 0 26 mm None 29 41 70 7 21 48 43 8 23 48 47 9 11 16 68 8 Trace 3 41 7 3 19 48 39 6...

Страница 32: ...lant Population Pooled NR3 CANR3 NR3 Only Mean Gradient mmHg 0 10 20 30 40 50 60 70 Baseline 30 Day 1 Year 37 2 19 0 18 8 33 2 13 4 13 7 36 1 17 4 17 3 Study Valve Size 23 26 All Peak Gradient mmHg 0...

Страница 33: ...Size 23 26 All Baseline 30 Day 1 Year Baseline 30 Day 1 Year Baseline 30 Day 1 Year 17 13 23 10 20 26 20 24 23 36 27 10 32 17 55 48 53 34 40 36 9 10 9 62 69 64 32 19 28 5 6 6 6 None Trace Mild Modera...

Страница 34: ...KCCQ Clinical Summary Score Attempted Implant Population I II III IV Percent 0 20 40 60 80 100 Pooled NR3 CANR3 NR3 Only Baseline 30 Day 6 Month 1 Year 5 58 38 48 41 10 66 21 13 45 39 12 4 Mean Score...

Страница 35: ...replacement or SAVR The SAPIEN XT valve was available in sizes 23 mm 26 mm and 29 mm Patients were enrolled from December 2011 to November 2013 The database reflected data collected through February 1...

Страница 36: ...SAVR ITT population 216 patients exited the study prior to the 2 year visit Of the remaining 805 patients who were due for the 2 year visit 710 patients 88 2 completed the 2 year visit and 95 patients...

Страница 37: ...y 321 1011 31 8 228 775 29 4 93 236 39 4 306 1021 30 0 Oxygen dependent 34 1011 3 4 20 775 2 6 14 236 5 9 32 1021 3 1 Atrial fibrillation 313 1011 31 0 245 775 31 6 68 236 28 8 359 1021 35 2 Permanent...

Страница 38: ...11 SAVR N 1021 Event No of Events Patients with Event No Patients at Risk K M Estimate No of Events Patients with Event No Patients at Risk K M Estimate Point Estimate Standard Error Point Estimate St...

Страница 39: ...confidence intervals are provided to illustrate the variability only and should not be used to draw any statistical conclusion Figure 19 All Cause Death through 2 Years ITT Population Note The confide...

Страница 40: ...n by access approach are presented in Table 24 The TF access had clinically lower all cause death and disabling major stroke rates than did the non TF access Table 24 All Cause Death or Disabling Majo...

Страница 41: ...issing or incomplete onset dates are excluded from the analysis Kaplan Meier estimates are provided at 2 years day 730 and use the first event per patient Events occurring after 730 days are not inclu...

Страница 42: ...derate severe 3 and severe 4 It was treated as a continuous variable and compared using the t test Table 26 Key Secondary Endpoints Comparisons Using the Hochberg Method AT VI Population Endpoint Summ...

Страница 43: ...Site Reported Events from Day 31 to 2 Years AT Population Adverse Event SAPIEN XT N 994 SAVR N 944 Relative Risk SAPIENXT versus SAVR Events Patients with Event No at Risk K M Estimate Standard Error...

Страница 44: ...secondary composite endpoint of all cause mortality disabling stroke or rehospitalization at 2 years is presented in Table 30 for the AT population Table 30 All Cause Death Disabling Major Stroke or...

Страница 45: ...c valve reintervention 4 0 4 3 0 4 1 0 4 0 0 0 Endocarditis 0 0 0 0 0 0 0 0 0 0 0 0 Rhythm disturbance requiring permanent pacemaker 85 8 4 62 8 0 23 9 7 68 6 7 2 Years Acute kidney injury 326 32 2 20...

Страница 46: ...was 236 8 86 9 min and the mean anesthesia time was 333 0 108 6 min General anesthesia was used in all patients It was difficult to wean 26 patients 2 8 from cardiopulmonary bypass which was terminat...

Страница 47: ...47 Figure 21 Effective Orifice Area VI Population Figure 22 Mean Gradient VI Population...

Страница 48: ...gitation VI Population None Trace Mild Mild Moderate Moderate Moderate Severe Severe Percentage 0 20 40 60 80 100 SAPIEN XT SAVR Baseline 30 Day 1 Year 2 Years Baseline 30 Day 1 Year 2 Years 14 21 26...

Страница 49: ...vular Leak VI Population None Trace Mild Mild Moderate Moderate Moderate Severe Severe Percentage 0 20 40 60 80 100 SAPIEN XT SAVR 30 Day 1 Year 2 Years 30 Day 1 Year 2 Years 22 29 32 77 81 83 52 44 3...

Страница 50: ...ts in NYHA Class III or IV was 76 at baseline 14 at 30 days 7 at 1 year and 7 at 2 years A side by side comparison of the results by access approach is presented in Figure 27 Figure 26 NYHA Class AT P...

Страница 51: ...yopathy Questionnaire KCCQ clinical summary score are presented in Figure 28 Improvements were observed in all sub scores at 30 days and were sustained at 1 and 2 years in the SAPIEN XT AT population...

Страница 52: ...52 Figure 28 KCCQ Clinical Summary Score AT Population Note Line Plot with mean and standard deviation Figure 29 KCCQ Clinical Summary Score TF versus non TF Access AT Population...

Страница 53: ...h evaluate physical the Physical Summary Score and mental the Mental Summary Score health with higher scores representing better functional health and well being The results of the VAS and SF 36 measu...

Страница 54: ...inical trials a consensus report from the Valve Academic Research Consortium J Am Coll Cardiol 2011 57 3 253 69 Piazza N et al 2011 Transcatheter aortic valve implantation for failing surgical aortic...

Страница 55: ...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 supplied steril...

Страница 56: ...9 mm NOTE The internal orifice diameter of the surgical bioprosthesis must be determined so that the appropriate valve size can be implanted The bioprosthesis internal diameter of the primary implante...

Страница 57: ...inal Inflation Volume Rated Burst Pressure RBP 9355FS23 23 mm 17 mL 7 atm 9355FS26 26 mm 22 mL 7 atm 9355FS29 29 mm 33 mL 7 atm Figure 2a NovaFlex Delivery System Figure 2b Default Position Figure 2c...

Страница 58: ...anting a valve that is too small may lead to paravalvular leak migration or embolization whereas implanting a valve that is too large may lead to residual gradient patient prosthesis mismatch or annul...

Страница 59: ...l annular calcification MAC severe 3 mitral insufficiency or Gorlin syndrome o Blood dyscrasias defined as leukopenia WBC 3000 cells mL acute anemia Hb 9 g dL thrombocytopenia platelet count 50 000 ce...

Страница 60: ...esia and the use of angiography Death Stroke transient ischemic attack clusters or neurological deficit Paralysis Permanent disability Respiratory insufficiency or respiratory failure Hemorrhage requi...

Страница 61: ...thickening stenosis Device degeneration Paravalvular or transvalvular leak Valve regurgitation Hemolysis Device explants Nonstructural dysfunction Mechanical failure of delivery system and or accessor...

Страница 62: ...record in the patient information documents Inspect the valve for any signs of damage to the frame or tissue 3 Rinse the valve as follows Place the valve in the first bowl of sterile physiological sal...

Страница 63: ...ing Delivery System Valve Size Inflation Volume Model 9355FS23 23 mm 17 mL Model 9355FS26 26 mm 22 mL Model 9355FS29 29 mm 33 mL 11 Close the stopcock to the 50 cc or larger syringe Remove the syringe...

Страница 64: ...the ACT at 250 sec during the procedure CAUTION Use of excessive contrast media may lead to renal failure Measure the patient s creatinine level prior to the procedure Contrast media usage should be...

Страница 65: ...Maintain guidewire position in the left ventricle during valve alignment 6 Advance the catheter and use the flex wheel if needed and cross the aortic valve NOTE Verify the Edwards logo is facing up Th...

Страница 66: ...Patient Information Patient education brochures are provided to each site and should be given to the patient to inform them of the risks and benefits of the procedure and alternatives in adequate time...

Страница 67: ...reduction in the Edwards SAPIEN XT cohort as compared to Edwards SAPIEN cohort for the following complications major vascular complications involving dissection from 9 2 to 4 3 p 0 0195 perforation fr...

Страница 68: ...reedom from all cause mortality at 1 year The KM estimate at 30 days involving freedom from all cause mortality was 94 9 2 8 There were no reported major strokes or incidence of renal failure cardiac...

Страница 69: ...nts were imposed because the 29 mm SAPIEN XT valve was not available when the study was initiated Contractors were utilized for analysis and interpretation of the clinical data including an independen...

Страница 70: ...V in SAV procedure the residual mean and peak gradients were numerically higher than those observed for TAVR procedures performed for native valve stenosis The NYHA class by visit is shown in Figure 2...

Страница 71: ...9 282 6 7 11 271 4 1 Chest wall deformity no total no 10 282 3 5 10 271 3 7 Liver disease no total no 12 282 4 3 13 271 4 8 Echocardiographic findings Aortic valve area cm 2 0 6 0 18 0 6 0 17 Mean aor...

Страница 72: ...19 282 6 7 16 271 5 90 22 282 7 80 21 271 7 75 AT As Treated NA not applicable TAVR transcatheter aortic valve replacement Data presented as n N of patients a CEC adjudicated b Deaths from unknown ca...

Страница 73: ...maker or ICD at baseline are included all patients included in denominator 2 Subjects with pacemaker or ICD at baseline are excluded patients with baseline pacemaker ICD subtracted from denominator No...

Страница 74: ...e presented in Figures 6 and 7 respectively The p value for each log rank test for the SAPIEN cohort shows a statistically significant difference among the 3 STS score groups p value 0 0336 Figure 6 A...

Страница 75: ...to 0 for patients still at risk at day 30 and day 30 was relabeled as day 0 The Kaplan Meier plots were produced based on the re zeroed data and all cause mortality was analyzed to one year from the n...

Страница 76: ...0 1 2 3 4 5 6 7 8 9 10 11 12 All Cause Mortality Months Post Procedure 1 STS 8 STS 8 15 STS 15 2 0 3 9 13 1 25 2 No at Risk p log rank 0 0718 6 7 22 4 Figure 10 Major Stroke to One Year AT Population...

Страница 77: ...7 8 9 10 11 12 Rehospitalization Months Post Procedure SAPIEN SAPIEN XT 10 7 11 6 24 2 23 1 No at Risk p log rank 0 7558 Figure 12 Effective Orifice Area Valve Implant Population 0 6 1 5 1 5 0 6 1 6 1...

Страница 78: ...of Echos SAPIEN 252 230 163 SAPIEN XT 273 241 174 P 0 5694 P 0 9700 Table 9 NYHA Functional Class by Visit AT Population SAPIEN Valve N 271 SAPIEN XT Valve N 282 Visit I II III IV Total I II III IV T...

Страница 79: ...76 204 192 263 249 284 I II III IV 16 12 6 Months 217 207 SAPIEN SAPIEN XT SAPIEN SAPIEN XT SAPIEN SAPIEN XT SAPIEN SAPIEN XT t 0 8007 t 0 7975 t 0 3810 t 0 4791 Figure 15 KCCQ Clinical Summary Score...

Страница 80: ...mmHg 40 3 11 67 Mean LVEF 46 1 14 52 Moderate or severe mitral regurgitation no total no 15 56 26 8 Note Plus minus values are means SD To convert the value for creatinine to micromoles per liter mul...

Страница 81: ...mol L with an acute increase of at least 0 5 mg dl 44 mol L d Disabling bleeding Fatal bleeding OR bleeding in a critical area or organ such as intracranial intraspinal intraocular or pericardial nec...

Страница 82: ...ifice Area Valve Implant Population 0 8 2 2 0 0 5 1 1 5 2 2 5 3 Baseline 30 Days Effective Orifice Area cm SAPIEN XT No of Echos SAPIEN XT 55 47 Effective orifice area data for this figure only contai...

Страница 83: ...2 103 995 10 4 Chest wall deformity no total no 18 1684 1 1 6 995 0 6 Liver disease no total no 52 1685 3 1 27 995 2 7 Echocardiographic findings Aortic valve area cm 2 0 7 0 21 0 7 0 21 Mean aortic v...

Страница 84: ...nosis or complications of the valve procedure e g TAVR c Disabling bleeding Fatal bleeding OR bleeding in a critical area or organ such as intracranial intraspinal intraocular or pericardial necessita...

Страница 85: ...maker 51 197 25 9 Pulmonary hypertension 26 197 13 2 Frailty 3 65 197 33 0 Extensively calcified aorta 12 197 6 1 Chest wall deformity 4 197 2 0 Liver disease 14 197 7 1 Reason for Valve Replacement M...

Страница 86: ...r Severe PV Leak 4 162 2 5 0 7 6 2 1 53 1 9 0 0 10 1 1 Composite of all cause mortality all stroke moderate or severe obstruction moderate or severe paravalvular leak Mortality and stroke are calculat...

Страница 87: ...er KM Event Rate for CEC Adjudicated Major Vascular Complications Major Stroke Minor Stroke TIA and Acute Kidney Injury Attempted Implant Population 30 Days N 197 1 Year N 97 VARC Event 1 Events Patie...

Страница 88: ...6 0 10 114 0 36 0 09 118 0 38 0 11 38 26 mm N 55 0 29 0 13 50 0 40 0 08 47 0 41 0 11 51 0 44 0 11 16 Mean Gradient mmHg mean SD n All Valve Sizes 36 1 16 38 179 18 2 7 79 168 17 4 7 37 176 17 3 8 76 5...

Страница 89: ...15 53 28 3 Mild 12 162 7 4 17 164 10 4 11 162 6 8 2 53 3 8 Moderate 8 162 4 9 4 164 2 4 3 162 1 9 1 53 1 9 Severe 3 162 1 9 1 164 0 6 1 162 0 6 0 53 0 0 23 mm None 92 121 76 0 55 116 47 4 68 114 59 6...

Страница 90: ...by Visit Valve Implant Population Pooled NR3 CANR3 NR3 Only DVI 0 1 0 2 0 3 0 4 0 5 0 6 Baseline 30 Day 1 Year 0 26 0 36 0 38 0 29 0 41 0 44 0 27 0 37 0 39 Study Valve Size 23 26 All Mean Gradient mmH...

Страница 91: ...10 20 30 40 50 60 70 80 90 100 110 Baseline 30 Day 1 Year 66 9 35 4 35 2 60 1 26 2 26 7 65 0 32 7 32 8 Study Valve Size 23 26 All None Trace Mild Moderate Severe Percent 0 20 40 60 80 100 Study Valve...

Страница 92: ...derate Severe Percent 0 20 40 60 80 100 Study Valve Size 23 26 All Baseline 30 Day 1 Year Baseline 30 Day 1 Year Baseline 30 Day 1 Year 76 71 75 12 7 11 8 5 7 15 5 60 48 56 32 42 35 6 8 7 65 69 66 30...

Страница 93: ...success was defined as successful vascular access delivery and deployment and retrieval of delivery system correct positioning of the valve intended performance mean aortic valve gradient 20 mmHg or p...

Страница 94: ...ding and could be adjudicated based on transfusion or hemoglobin drop alone Also an ECG core laboratory was used for independent analysis of rhythm and an echocardiographic core laboratory for indepen...

Страница 95: ...75 23 1 60 236 25 4 261 1021 25 6 Percutaneous coronary intervention 274 1011 27 1 202 775 26 1 72 236 30 5 282 1021 27 6 Prior aortic valvuloplasty 51 1011 5 0 35 775 4 5 16 236 6 8 50 1021 4 9 Cereb...

Страница 96: ...d for the ITT population in Table 25 and Figures 25 27 The K M estimate of the composite event for SAPIEN XT was found to be non inferior to that for SAVR 19 3 vs 21 1 p 0 0014 Table 25 All Cause Deat...

Страница 97: ...confidence intervals are provided to illustrate the variability only and should not be used to draw any statistical conclusion Figure 26 All Cause Death through 2 Years ITT Population Note The confide...

Страница 98: ...F access Table 26 All Cause Death or Disabling Major Stroke to 2 Years by Access Approach SAPIEN XT ITT Population TF N 775 Non TF N 236 Event No of Events Patients with Event No Patients at Risk K M...

Страница 99: ...at 2 years ITT 203 2 132 4 615 209 8 153 5 513 6 6 23 5 10 3 0 0001 EOA at 2 years VI 1 5 0 4 567 1 4 0 4 488 0 1 0 09 0 19 0 0001 Mean SD n Difference 95 CI Total AR was graded as none 0 trace 1 mild...

Страница 100: ...cy aortic stenosis permanent pacemaker implantation mitral valve injury or insufficiency or renal insufficiency Table 30 Composite Endpoint of 14 Pre specified Site Reported Events from Day 31 to 2 Ye...

Страница 101: ...re day 31 or after day 730 are excluded from the analysis The result for the third adjunctive secondary composite endpoint of all cause mortality disabling stroke or rehospitalization at 2 years is pr...

Страница 102: ...0 0 0 0 0 0 0 0 Rhythm disturbance requiring permanent pacemaker 85 8 4 62 8 0 23 9 7 68 6 7 2 Years Acute kidney injury 326 32 2 206 26 6 120 50 8 404 39 6 Stage III 36 3 6 18 2 3 18 7 6 57 5 6 Deat...

Страница 103: ...the mean anesthesia time was 333 0 108 6 min General anesthesia was used in all patients It was difficult to wean 26 patients 2 8 from cardiopulmonary bypass which was terminated in the majority of c...

Страница 104: ...50 Figure 29 Mean Gradient VI Population Figure 30 Peak Gradient VI Population...

Страница 105: ...IV was 76 at baseline 14 at 30 days 7 at 1 year and 7 at 2 years A side by side comparison of the results by access approach is presented in Figure 34 None Trace Mild Mild Moderate Moderate Moderate S...

Страница 106: ...Class TF versus non TF Access AT Population 1 2 3 4 Percent 0 20 40 60 80 100 TF Non TF Baseline 30 Day 6 Month 1 Year 2 Years Baseline 30 Day 6 Month 1 Year 2 Years 22 60 18 58 35 8 68 27 4 66 27 6 6...

Страница 107: ...yopathy Questionnaire KCCQ clinical summary score are presented in Figure 35 Improvements were observed in all sub scores at 30 days and were sustained at 1 and 2 years in the SAPIEN XT AT population...

Страница 108: ...54 Figure 35 KCCQ Clinical Summary Score AT Population Note Line Plot with mean and standard deviation Figure 36 KCCQ Clinical Summary Score TF versus non TF Access AT Population...

Страница 109: ...h evaluate physical the Physical Summary Score and mental the Mental Summary Score health with higher scores representing better functional health and well being The results of the VAS and SF 36 measu...

Страница 110: ...port from the Valve Academic Research Consortium J Am Coll Cardiol 2011 57 3 253 69 Piazza N et al 2011 Transcatheter aortic valve implantation for failing surgical aortic bioprosthetic valve from con...

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