Edwards SAPIEN XT Instructions For Use Manual
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Edwards SAPIEN XT Instructions For Use Manual

Edwards SAPIEN XT Instructions For Use Manual

Transcatheter heart valve with the ascendra+ delivery system
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Edwards SAPIEN XT
Transcatheter Heart Valve with the Ascendra+ Delivery System
Instructions for Use
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Implantation of the transcatheter heart valve should be performed only by physicians who
have received Edwards Lifesciences training. The implanting physician should be experienced
in balloon aortic valvuloplasty.
Please verify that you have the latest version of the instructions 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 supplied sterilized with glutaraldehyde solution. The delivery system is
supplied sterilized with ethylene oxide gas.
_________________________________________________________________________________________
Edwards, Edwards Lifesciences, the stylized E logo, Ascendra, Ascendra+, Carpentier-Edwards,
Edwards SAPIEN, Edwards SAPIEN XT, PARTNER and PARTNER II, SAPIEN, SAPIEN XT, TFX, and
ThermaFix are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their
respective owners.
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  • Page 1 _________________________________________________________________________________________ Edwards, Edwards Lifesciences, the stylized E logo, Ascendra, Ascendra+, Carpentier-Edwards, Edwards SAPIEN, Edwards SAPIEN XT, PARTNER and PARTNER II, SAPIEN, SAPIEN XT, TFX, and ThermaFix are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their...
  • Page 2 1.0 Device Description • Edwards SAPIEN XT Transcatheter Heart Valve – Model 9300TFX (Figure 1) The Edwards SAPIEN XT transcatheter heart valve is comprised of a balloon-expandable, radiopaque, cobalt-chromium frame, trileaflet bovine pericardial tissue valve, and a polyethylene terephthalate (PET) fabric skirt. The leaflets are treated according to the Carpentier-Edwards ThermaFix process.
  • Page 3 7 atm 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 ≥...
  • Page 4 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...
  • Page 5 For more information about glutaraldehyde exposure, refer to the Material Safety Data Sheet available from Edwards Lifesciences. • To maintain proper valve leaflet coaptation, do not overinflate the deployment balloon.
  • Page 6 • The safety and effectiveness have not been established for implanting the transcatheter valve inside a stented bioprosthetic valve < 21 mm (labeled size) or an unstented bioprosthetic aortic valve. • Residual mean gradient may be higher in a "TAV-in-SAV" configuration than that observed following implantation of the valve inside a native aortic annulus using the same size device.
  • Page 7 • Hypertension or hypotension • Allergic reaction to anesthesia, contrast media, or device materials • Hematoma • Syncope • Pain or changes at the access site • Exercise intolerance or weakness • Inflammation • Angina • Heart murmur • Fever Additional potential risks associated with the use of the valve, delivery system, and/or accessories include: •...
  • Page 8 9355AS29 Ascendra+ Introducer Sheath 9350IS23 9350IS26 9350IS29 Ascendra Balloon Aortic 9100BAVC Valvuloplasty Catheter Inflation devices provided by Edwards Lifesciences Edwards Crimper 9350CR * Includes the Crimp Stopper Additional Equipment: • 20 cc syringe or larger (x2) • 50 cc syringe or larger •...
  • Page 9 Completely fill the inflation device provided by Edwards with diluted contrast and attach to the extension tubing stopcock. Ensure there are no air bubbles in the balloon. If an air bubble is detected,...
  • Page 10 Step Procedure Remove excess contrast medium from the inflation device provided by Edwards into the syringe to achieve the appropriate volume required to deploy the valve per the following. Then lock the inflation device: Delivery System Valve Inflation Volume Model 9355AS23...
  • Page 11 Step Procedure Remove the stylet and flush the guidewire lumen of the delivery system. CAUTION: The implanting physician must verify correct orientation of the valve prior to its implantation. 7.3 Valvuloplasty and Valve Delivery Valvuloplasty and valve delivery should be performed under general anesthesia with hemodynamic monitoring in a catheterization lab/hybrid operating room with fluoroscopic and echocardiographic imaging capabilities.
  • Page 12 • Deploy the valve by inflating the balloon with the entire volume in the Inflation device provided by Edwards Lifesciences, hold for 3 seconds and confirm that the barrel of the inflation device is empty to ensure complete inflation of the balloon. When the balloon catheter has been completely deflated, turn off the pacemaker.
  • Page 13 NR3: Registry for Transcatheter Heart Valve in Aortic Surgical Valve Implantation (THV- SV). Patients with failing aortic bioprosthetic surgical valve with a surgical mortality or major morbidity ≥ 50% and meeting the sizing requirements for 23 mm or 26 mm SAPIEN XT valve. •...
  • Page 14 7.2%, renal failure or AKI in 20.5% and 11% of patients had a new pacemaker implanted. Of the 2688 patients that were enrolled, fifty-seven (57) of these patients had the 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.
  • Page 15 23 mm or 26 mm SAPIEN XT valve. The specific sizing requirements 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 independent...
  • Page 16 The NYHA class by visit is shown in Figure 16. About 89% of subjects were in NYHA I/II at 30 days and 84% at 1 year as compared to 5% at baseline. The mean improvement in 6MWD among the Attempted Implant population was 49.8 ± 169.9 meters from baseline to 30 days and 86.1 ±...
  • Page 17 PARTNER II Cohort B Registries Clinical Data Table 6: Cohort B (Inoperable) Baseline Characteristics and Echocardiographic Findings for NR1, NR4 and NR6 (AT Population)* SAPIEN XT Valve (TA/TAo) Characteristic (N = 265) Age - yr 82.0 ± 7.79 Male sex — no. (%) 141/265 (53.2%)
  • Page 18 Table 7: Cohort B (Inoperable) Clinical Outcomes at 30 days for NR1, NR4 and NR6 (AT Population)* SAPIEN XT Valve Outcome (N = 265) Death from any cause 21/265 (7.9%) Major Stroke 5/265 (1.9%) Repeat hospitalization 8/265 (3.0%) Death from any cause or major stroke or repeat hospitalization 31/265 (11.7%)
  • Page 19 Figure 3: All-Cause Mortality, Major Stroke or Re-Hospitalization to 30 Days, NR1, NR4, and NR6 – TA/TAo (AT Population) SAPIEN XT 11.8% Days Post-Procedure No. at Risk SAPIEN XT...
  • Page 20 Figure 4: All-Cause Mortality to 30 Days, NR1, NR4, and NR6 – TA/TAo SAPIEN XT 8.0% Days Post-Procedure No. at Risk SAPIEN XT Figure 5: Major Stroke at 30 Days, NR1, NR4, and NR6 – TA/TAo (AT Population) SAPIEN XT 1.9%...
  • Page 21 Figure 6: Re-Hospitalization at 30 Days, NR1, NR4, and NR6 –TA/TAo (AT Population) SAPIEN XT 3.2% Days Post-Procedure No. at Risk SAPIEN XT Figure 7: Effective Orifice Area, NR1, NR4, and NR6 – TA/TAo (Valve Implant Population) SAPIEN XT Baseline 30 Days No.

  • Page 22: Table Of Contents

    Mean Gradient, NR1, NR4, and NR6 – TA/TAo (Valve Implant Population) SAPIEN XT 41.2 Baseline 30 Days No. of Echos SAPIEN XT Table 9: NYHA Functional Class By Visit for NR1, NR4 and NR6 (AT Population) SAPIEN XT Valve (N = 265) Visit Total Baseline 30 Days...

  • Page 23: Baseline

    100% 4.8% 19.4% 31.3% 38.8% 58.1% 37.0% 10.1% 0.4% TA/TAo TA/TAo Baseline 30 Days Figure 10: KCCQ Clinical Summary Score, NR1, NR4, and NR6 – TA/TAo (AT Population) SAPIEN XT 56.6 50.0 Baseline 30 Days No. of Pts SAPIEN XT...
  • Page 24 SOURCE XT Clinical Data Table 10: SOURCE XT (High Risk) Baseline Characteristics of the Patients and Echocardiographic Findings (AT Population)* Transfemoral TA/TAo Pooled Characteristic (N = 1685) (N = 995) Age - yr 82.0 ± 6.5 80.3 ± 6.5 Male sex — no. (%) 600 / 1685 (35.6%) 536 / 995 (53.9%) †...

  • Page 25: 30 Days

    Table 11: SOURCE XT (High Risk) Clinical Outcomes at 30 days and 1 year (AT Population)* 30 Days 1-Year Transfemoral TA/TAo Transfemoral TA/TAo Outcome (N = 1685) (N = 995) (N = 1685) (N = 995) All Cause Death 71 (4.2%) 96 (9.7%) 248 (15.0%) 266 (27.0%)
  • Page 26 Table 13: Demographic and Baseline Characteristics Attempted Implant Population Results (N=197) Characteristic Age – yr 78.5 ± 11.00 Male sex 119/197 (60.4%) STS score 9.7 ± 5.09 New York Heart Association (NYHA) class I/II 9/197 (4.6%) III/IV 188/197 (95.4%) Coronary artery disease 139/197 (70.6%) Previous myocardial infarction 25/197 (12.7%)

  • Page 27: Table 14

    Table 14: Summary of Failed Bioprosthetic Surgical Valves Attempted Implant Population Results (N=197) Type of Failed Surgical Valve Bioprosthesis 184 / 195 (94.4%) Homograft 9 / 195 (4.6%) Other 2 / 195 (1.0%) Reason for Valve Replacement Mixed Lesion 45/192 (23.4%) Insufficiency/regurgitation Only 43/192 (22.4%) Stenosis Only...
  • Page 28 Table 16: CEC Adjudicated Adverse Events Attempted Implant Population Rate (no./total no. (%)) Adverse Events 30 Days 1 Year (N=197) (N=97) Death From any cause 8/197 (4.1%) 19/97 (19.6%) From cardiovascular cause 7/197 (3.6%) 15/97 (15.5%) Major Stroke 5/197 (2.5%) 3/97 (3.1%) Myocardial Infarction 5/197 (2.5%)
  • Page 29 Table 17: Kaplan-Meier (KM) Event Rate for CEC Adjudicated Major Vascular Complications, Major Stroke, Minor Stroke, TIA, and Acute Kidney Injury Attempted Implant Population 30 Days 1 Year (N=197) (N=97) Patients Patients with with VARC Event Events Event Estimate 95% CI Events Event Estimate...
  • Page 30 Table 19: Valve Hemodynamics Measured by Echocardiography Valve Implant Population Baseline Discharge 30 Days 1 Year (N=195) (N=195) (N=195) (N=96) Doppler Velocity Index - mean ± SD (n) All Valve Sizes 0.27 ± 0.10 (173) 0.37 ± 0.09 (161) 0.37 ± 0.09 (169) 0.39 ±...
  • Page 31 Table 19: Valve Hemodynamics Measured by Echocardiography Valve Implant Population Baseline Discharge 30 Days 1 Year (N=195) (N=195) (N=195) (N=96) 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%)
  • Page 32 Figure 12: Mean Gradient by Visit Valve Implant Population Study Valve Size 37.2 36.1 33.2 19.0 18.8 17.4 17.3 13.4 13.7 Baseline 30 Day 1 Year Pooled NR3/CANR3 NR3 Only Figure 13: Peak Gradient by Visit Valve Implant Population Study Valve Size 66.9 65.0 60.1...
  • Page 33 Figure 14: Total Aortic Regurgitation by Visit Valve Implant Population None Trace Mild Moderate Severe Baseline 30 Day 1 Year Baseline 30 Day 1 Year Baseline 30 Day 1 Year Study Valve Size Figure 15: Paravalvular Leak by Visit Valve Implant Population None Trace Mild...
  • Page 34 Figure 16: NYHA Class by Visit Attempted Implant Population Baseline 30 Day 6 Month 1 Year Pooled NR3/CANR3 NR3 Only Figure 17: KCCQ Clinical Summary Score Attempted Implant Population 70.4 68.0 45.5 Baseline 30 Day 1 Year...
  • Page 35 PIIA was a 1:1 randomized, controlled study independently powered to compare the results of TAVR with the SAPIEN XT valve to traditional, open-heart aortic valve surgery (i.e., surgical aortic valve replacement or SAVR). The SAPIEN XT valve was available in sizes 23 mm, 26 mm, and 29 mm.
  • Page 36 Valve Implant (VI): All As Treated patients whose valve implant process is completed. In the SAPIEN XT ITT population, 187 patients exited the study prior to the 2-year visit. Of the remaining 824 patients who were due for the 2-year visit, 784 patients (95.1%) completed the 2- year visit, and 40 patients (4.9%) missed the 2-year visit.
  • Page 37 Table 22: Demographics and Baseline Characteristics (ITT Population) SAPIEN XT Demographics & SAVR Characteristic TF only Non-TF Only (N = 1021) (N = 1011) (N = 775) (N = 236) (66.5%) Previous Myocardial 179/1021 185/1011 (18.3%) 137/775 (17.7%) 48/236 (20.3%) Infarction (17.5%)
  • Page 38 2 years and each component are presented for the ITT population in Table 23 and Figures 18-20. 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).
  • Page 39 Figure 18: All-Cause Death or Disabling (Major) Stroke through 2 Years (ITT Population) Note: The confidence intervals at 30 days and 12 months were calculated without multiplicity adjustment. 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 statistical conclusion.
  • Page 40 The results for the primary endpoint and its components for the SAPIEN XT ITT population 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.
  • Page 41 (AT) population in Table 26. SAPIEN XT was found to be non-inferior to SAVR in NYHA class at 2 years, DAOH to 2 years, 6MWT distance at 2 years, and EOA at 2 years. The 6MWT distance at 2 years was superior to that at baseline in the SAPIEN XT patients.
  • Page 42 Change in 6MWT Reject null hypothesis distance from baseline to 14.5±128.7 and conclude non- 0.0057 0.025 2 years (SAPIEN XT (604) inferiority for the rest only; ITT) of endpoints NYHA class at 2 years 1.5±0.7 1.4±0.6 <0.0001...
  • Page 43 Tables 27 and 28. Table 27: Composite Endpoint of 14 Pre-specified Site-Reported Events to 30 Days or Discharge (AT Population) Relative Risk SAPIEN XT (N = 994) SAVR (N = 944) SAPIEN XT Adverse Event Patients with...
  • Page 44 SAPIEN XT (N = 994) SAVR (N = 944) Relative Risk Events/Patients Events/Patients K-M Estimate Event SAPIEN XT K-M Estimate with Event/No. at with Event/No. at (Standard vs SAVR (Standard Error) Risk Risk Error) All stroke, major vascular 210/176/684 18.1% (1.24%) 156/132/644 14.4% (1.16%)
  • Page 45 Adverse Events Results for some key CEC-adjudicated adverse events through 2 years are presented in Table 31 for the ITT population. Table 31: Key CEC-Adjudicated Adverse Events (ITT Population) SAPIEN XT SAVR Overall TF Access Non-TF Access (N = 1021)
  • Page 46 ≥ moderate was 3.8% at 30 days, 3.4% at 1 year, and 8.0% at 2 years in the SAPIEN XT arm, as compared to 0.5% at 30 days, 0.3% at 1 year, and 0.6% at 2 years in the SAVR arm.
  • Page 47 Figure 21: Effective Orifice Area (VI Population) Figure 22: Mean Gradient (VI Population)
  • Page 48 Figure 23: Peak Gradient (VI Population) Figure 24: Total Aortic Regurgitation (VI Population) None Trace Mild Mild-Moderate Moderate Moderate-Severe Severe Baseline 30 Day 1 Year 2 Years Baseline 30 Day 1 Year 2 Years SAPIEN XT SAVR...
  • Page 49 Figure 25: Aortic Paravalvular Leak (VI Population) None Trace Mild Mild-Moderate Moderate Moderate-Severe Severe 30 Day 1 Year 2 Years 30 Day 1 Year 2 Years SAPIEN XT SAVR...
  • Page 50 NYHA The NYHA classifications by visit are presented in Figure 26. In the SAPIEN XT AT population, 78% of the patients were in NYHA Class III or IV at baseline, which reduced to 11% at 30 days, 8% at 1 year, and 10% at 2 years, while in the SAVR AT population, the percentage of patients in NYHA Class III or IV was 76% at baseline, 14% at 30 days, 7% at 1 year, and 7% at 2 years.
  • Page 51 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. A side-by-side comparison of the results by access approach is presented in Figure 29. In general, improvements in the TF group were slightly larger compared to those observed in the non-TF group.
  • Page 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)
  • Page 53 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 measures are presented in Tables 33 and 34, respectively. Table 33: EQ-5D Utilities Score (AT Population) SAPIEN XT EQ-5D Utilities Score SAVR Non-TF Baseline 0.7±0.2 0.7±0.2...
  • Page 54 These products are manufactured and sold under one or more of the following US patent(s): US Patent No. 6,214,054; 6,547,827; 6,908,481; 7,214,344; 7,510,575; 7,530,253; 7,895,876; 7,993,394; 8,439,970; 8,475,522; 8,764,820; and 8,945,208; and corresponding foreign patents. Additional patents are pending. 07/2016 ©Copyright 2016, Edwards Lifesciences LLC All rights reserved. Manufacturer Telephone 949.250.2500...
  • Page 55 Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Edwards SAPIEN, Edwards SAPIEN XT, NovaFlex, NovaFlex+, PARTNER, PARTNER II, Qualcrimp, RetroFlex, RetroFlex 3, SAPIEN, SAPIEN XT, TFX, and ThermaFix are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
  • Page 56 • NovaFlex+ Delivery System (Figures 2a, 2b, 2c) The NovaFlex+ delivery system (usable length 105 cm) is used for delivery of the Edwards SAPIEN XT transcatheter heart valve. The delivery system includes a flex wheel for articulation of the flex catheter, a tapered tip at the distal end of the delivery system to facilitate crossing the valve, and a balloon catheter for deployment of the valve.
  • Page 57 defining the valve alignment position and the working length of the balloon. A radiopaque double marker proximal to the balloon indicates flex catheter position during deployment. The inflation parameters for valve deployment are: Table 4 Nominal Balloon Nominal Inflation Rated Burst Model Diameter Volume...
  • Page 58 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).
  • Page 59 “unfolding” and tortuosity of the thoracic aorta o Access characteristics that would preclude safe placement of 16F, 18F, or 20F Edwards Expandable Introducer Sheath Set, such as severe obstructive calcification, severe tortuosity or diameter less than 6 mm, 6.5 mm, or 7 mm, respectively...
  • Page 60 • Residual mean gradient may be higher in a “TAV-in-SAV” configuration than that observed following implantation of the valve inside a native aortic annulus using the same size device. Patients with elevated mean gradient post procedure should be carefully followed. It is important that the manufacturer, model and size of the preexisting surgical bioprosthetic aortic valve be determined, so that the appropriate valve can be implanted and a prosthesis-patient mismatch be avoided.
  • Page 61 Introducer Sheath Set** Edwards Dilator Kit 9100DKS Edwards Balloon Catheter 9350BC20 9350BC23 9350BC25 Inflation devices provided by Edwards Lifesciences Edwards Crimper 9350CR * Includes the Qualcrimp Crimping Accessory and 2-piece Crimp Stopper ** Or other compatible sheath provided by Edwards Lifesciences...
  • Page 62 The valve should be kept hydrated to prevent the tissue from drying. 7.2.2 Prepare the Components Refer to the Edwards Dilator Kit, Edwards Expandable Introducer Sheath Set, Edwards Crimper and Edwards Balloon Catheter instructions for use for device preparation.
  • Page 63 Lock the inflation device and attach to the 3-way stopcock. Close the 3-way stopcock to the Inflation device provided by Edwards Lifesciences and de-air the system using the 50 cc or larger syringe. Slowly release the plunger and leave zero-pressure in the system.
  • Page 64 CAUTION: Valve implantation should not be carried out if the balloon cannot be fully inflated during valvuloplasty. 7.3.3 Valve Delivery Step Procedure Dilate the access site using the Edwards Dilator Kit, if needed. Refer to the Edwards Dilator Kit IFU for information on device preparation and handling.
  • Page 65 • Deploy the valve by inflating the balloon with the entire volume in the Inflation device provided by Edwards Lifesciences, hold for 3 seconds and confirm that the barrel of the inflation device is empty to ensure complete inflation of the balloon. Deflate the balloon. When the balloon catheter has been completely deflated, turn off the pacemaker.
  • Page 66 • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode) Under the scan conditions defined above, the SAPIEN XT transcatheter heart valve is expected to produce a maximum temperature rise of 2.6 °C after 15 minutes of continuous scanning.
  • Page 67 NYHA at 1 year: In the SAPIEN cohort, mean NYHA was 3.5 ± 0.6 at baseline and 1.8 ± 0.8 at 1 year which constituted a reduction of 1.7 ± 0.9. In the SAPIEN XT cohort, mean NYHA was 3.4 ± 0.6 at baseline and 1.7 ±...
  • Page 68 AR), and only one valve implanted. The proportion of device success was 45.3% in the SAPIEN cohort and 58.5% in the SAPIEN XT cohort. The relative risk ratio of SAPIEN XT cohort vs. SAPIEN cohort was 0.759 (95% CI 0.582, 0.990), p<0.0001.

  • Page 69: Disposition Is Summarized In Table

    ≥ 50% for replacement of a failing surgical aortic valve and met the sizing requirements for the 23 mm or 26 mm SAPIEN XT valve. The specific sizing requirements were imposed because the 29 mm SAPIEN XT valve was not available when the study was initiated.
  • Page 70 No unanticipated adverse device effects (UADEs) were reported throughout the trial. Three explants have been reported to date; one explant occurred at autopsy, and two during surgical aortic valve replacement due to severe aortic insufficiency on postoperative day 5 and day 18, respectively. No CEC adjudicated endocarditis was reported.

  • Page 71: (At Population) Sapien Xt Valve (N = 265)

    PARTNER II Cohort B Clinical Data Table 6: Cohort B (Inoperable) Baseline Characteristics of the Patients and Echocardiographic Findings (AT Population)* SAPIEN XT Valve SAPIEN Valve Characteristic (N = 282) (N = 271) Age - yr 84.0 ± 8.68 84.5 ± 8.65 Male sex —...
  • Page 72 Table 7: Cohort B (Inoperable) Clinical Outcomes at 30 days and 1 year (AT Population)* 30 Days 1 Year SAPIEN SAPIEN XT SAPIEN SAPIEN XT Outcome Valve Valve Valve Valve (N = 282) (N = 271) (N = 282) (N = 271)
  • Page 73 Table 8: Conduction Disturbance Requiring Pacemaker (CEC Adjudicated) Pooled AT Population) SAPIEN Valve SAPIEN XT Valve (N = 271) (N = 282) Event Patients with Patients with Events Event Events Event New Permanent Pacemaker – All Patients 0-30 Days 16/271 (5.9%) 19/282 (6.7%)
  • Page 74 K-M curves for all-cause mortality by STS scores up to 1-Year for the pooled valve implant populations for the SAPIEN cohort and the SAPIEN XT cohort are 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).
  • Page 75 Figures 8 and 9 show the results of a landmark analysis of all-cause mortality by STS scores for SAPIEN cohort and SAPIEN XT cohort respectively. In this analysis the overall mortality at day 30 was reset 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 new day 0.
  • Page 76 Figure 9: All-Cause Mortality by STS Score Rezeroing at 30-Days – SAPIEN XT Valve (Intent to Treat Population) STS <8 STS 8-15 STS >15 25.2% 22.4% 6.7% 13.1% 3.9% 2.0% p (log rank) = 0.0718 Months Post-Procedure - 1 No. at Risk STS <8...
  • Page 77 Figure 11: Rehospitalization to One Year (AT Population) SAPIEN SAPIEN XT 24.2% 11.6% 23.1% 10.7% p (log rank) = 0.7558 Months Post-Procedure No. at Risk SAPIEN SAPIEN XT Figure 12: Effective Orifice Area (Valve Implant Population) SAPIEN P = 0.2827 P = 0.6405...
  • Page 78 11.4 11.0 10.0 Baseline 30 Days 1 Year No. of Echos SAPIEN SAPIEN XT Table 9: NYHA Functional Class by Visit AT Population SAPIEN Valve SAPIEN XT Valve (N=271) (N=282) Visit Total Total Baseline 30 Days 6 Months 1 Year...
  • Page 79 100% SAPIEN SAPIEN SAPIEN SAPIEN SAPIEN SAPIEN SAPIEN SAPIEN 6 Months Baseline 30 Days 1 Year Figure 15: KCCQ Clinical Summary Score (AT Population) SAPIEN SAPIEN XT 67.53 63.02 64.49 62.45 44.18 43.64 Baseline 30 Days 1 Year...
  • Page 80 Table 10: Cohort B (29 mm / Transfemoral / Inoperable) Baseline Characteristics of the Patients and Echocardiographic Findings (Intent to Treat Population) SAPIEN XT Valve Characteristic (N= 61) Age - yr 83.3 ± 7.89 Male sex — no. (%) 61 (100.0%) STS score†...
  • Page 81 Table 11: Cohort B (29 mm / Transfemoral / Inoperable) – CEC Adjudicated Adverse Events at 30 days (AT Population)* SAPIEN XT Valve Outcome N=61 Death From any cause 3/61 (4.9%) From cardiovascular cause 3/61 (4.9%) Major Stroke 0/61 (0.0%) Myocardial Infarction 1/61 (1.6%)
  • Page 82 Figure 17: Cohort B (29 mm / Transfemoral / Inoperable) – Effective Orifice Area (Valve Implant Population) SAPIEN XT Baseline 30 Days No. of Echos SAPIEN XT Effective orifice area data for this figure only contains data from 29 mm valve sizes and does not include...
  • Page 83 SOURCE XT Clinical Data Table 12: SOURCE XT (High Risk) Baseline Characteristics of the Patients and Echocardiographic Findings (AT Population) Transfemoral TA/TAo Pooled Characteristic (N = 1685) (N = 995) Age - yr 82.0 ± 6.5 80.3 ± 6.5 Male sex — no./total no. (%) 600/1685 (35.6%) 536/995 (53.9%) STS score†...
  • Page 84 Table 13: SOURCE XT (High Risk) Clinical Outcomes at 30 days and 1 year (AT Population)* 30 Days 1-Year Outcome Transfemoral TA/TAo Transfemoral TA/TAo (N = 1685) (N = 995) (N = 1685) (N = 995) All Cause Death 71 (4.2%) 96 (9.7%) 248 (15.0%) 266 (27.0%)

  • Page 85: Extensively Calcified Aorta

    Table 15: Demographic and Baseline Characteristics Attempted Implant Population Characteristic Results (N=197) Age – yr 78.5 ± 11.00 Male sex 119/197 (60.4%) STS score 9.7 ± 5.09 New York Heart Association (NYHA) class I/II 9/197 (4.6%) III/IV 188/197 (95.4%) Coronary artery disease 139/197 (70.6%) Previous myocardial infarction 25/197 (12.7%)

  • Page 86: Reason For Valve Replacement

    Table16: Summary of Failed Bioprosthetic Surgical Valves Attempted Implant Population Results (N=197) Type of Failed Surgical Valve Bioprosthesis 184/195 (94.4%) Homograft 9/195 (4.6%) Other 2/195 (1.0%) Reason for Valve Replacement Mixed Lesion 45/192 (23.4%) Insufficiency/regurgitation Only 43/192 (22.4%) Stenosis Only 104/192 (54.2%) Categorical data are expressed as no./total no.
  • Page 87 Rate (no./total no. (%)) Adverse Events 30 Days 1 Year (N=197) (N=97) Cardiac Reintervention 4/197 (2.0%) 2/97 (2.1%) Endocarditis 0/197 (0.0%) 0/97 (0.0%) New Atrial Fibrillation 4/135 (3.0%) 2/45 (4.4%) New Pacemaker 3/197 (1.5%) 1/97 (1.0%) Deaths from unknown causes were assumed to be deaths from cardiovascular causes. Acute kidney injury, stage III is defined as an increase in serum creatinine to ≥...
  • Page 88 Table 20: Conduction Disturbance Requiring New Permanent Pacemaker Attempted Implant Population 30 Days 1 Year (N=197) (N=97) Patients Patients Events Events with Event with Event New Permanent 3/197 (1.5%) 1/97 (1.0%) Pacemaker- All Patients New Permanent Pacemaker 3/146 (2.1%) 1/70 (1.4%) –...
  • Page 89 Baseline Discharge 30 Days 1 Year (N=195) (N=195) (N=195) (N=96) 26 mm None 1/50 (2.0%) 19/48 (39.6%) 23/48 (47.9%) 11/16 (68.8%) Trace 5/50 (10.0%) 21/48 (43.8%) 19/48 (39.6%) 3/16 (18.8%) Mild 10/50 (20.0%) 7/48 (14.6%) 5/48 (10.4%) 1/16 (6.3%) Moderate 18/50 (36.0%) 1/48 (2.1%) 1/48 (2.1%)

  • Page 90: Figure

    Figure 18: Doppler Velocity Index by Visit Valve Implant Population Study Valve Size 0.41 0.44 0.37 0.39 0.29 0.36 0.38 0.27 0.26 Baseline 30 Day 1 Year Pooled NR3/CANR3 NR3 Only Figure 19: Mean Gradient by Visit Valve Implant Population Study Valve Size 37.2 36.1...
  • Page 91 Figure 20: Peak Gradient by Visit Valve Implant Population Study Valve Size 66.9 65.0 60.1 35.4 35.2 32.7 32.8 26.2 26.7 Baseline 30 Day 1 Year Pooled NR3/CANR3 NR3 Only Figure 21: Total Aortic Regurgitation by Visit Valve Implant Population None Trace Mild...
  • Page 92 Figure 22: Paravalvular Leak by Visit Valve Implant Population None Trace Mild Moderate Severe Baseline 30 Day 1 Year Baseline 30 Day 1 Year Baseline 30 Day 1 Year Study Valve Size Figure 23: NYHA Class by Visit Attempted Implant Population Baseline 30 Day 6 Month...
  • Page 93 Figure 24: KCCQ Clinical Summary Score Attempted Implant Population 70.4 68.0 45.5 Baseline 30 Day 1 Year Table 22: Device Success and Reason for Device Failure Valve Implant Population Device Success Rate Success 115/187 (61.5%) Failure 72/187 (38.5%) Factor 1: Unsuccessful access, delivery, deployment, or retrieval of delivery system 11/72 (15.3%) Factor 2: Position - Too Aortic or Too Ventricular 2/72 (2.8%)
  • Page 94 SAPIEN XT valve to traditional, open-heart aortic valve surgery (i.e., surgical aortic valve 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, 2016 and included 1,011 patients in the SAPIEN XT arm and 1,021 patients in the SAVR arm at 57 investigational sites in the U.S.
  • Page 95 Table 24: Demographics and Baseline Characteristics (ITT Population) SAPIEN XT Demographics & SAVR TF only Non-TF Only Characteristic (N = 1021) (N = 1011) (N = 775) (N = 236) Age (Years) 81.5±6.7 81.8±6.7 80.6±6.6 81.7±6.7 548/1011 560/1021 Male Sex 426/775 (55.0%)
  • Page 96 The results of the composite primary endpoint of all-cause death or disabling (major) stroke at 2 years and each component are presented 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).
  • Page 97 Figure 25: All-Cause Death or Disabling (Major) Stroke through 2 Years (ITT Population) Note: The confidence intervals at 30 days and 12 months were calculated without multiplicity adjustment. 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 statistical conclusion.
  • Page 98 The results for the primary endpoint and its components for the SAPIEN XT ITT population by access approach are presented in Table 26. The TF access had clinically lower all-cause death and disabling (major) stroke rates than did the non-TF access.
  • Page 99 ITT population in Table 27 and for the as- treated (AT) population in Table 28. SAPIEN XT was found to be non-inferior to SAVR in NYHA class at 2 years, DAOH to 2 years, 6MWT distance at 2 years, and EOA at 2 years. The 6MWT distance at 2 years was superior to that at baseline in the SAPIEN XT patients.

  • Page 100: At Population

    Tables 29 and 30. Table 29: Composite Endpoint of 14 Pre-specified Site-Reported Events to 30 Days or Discharge (AT Population) Relative Risk SAPIEN XT (N = 994) SAVR (N = 944) SAPIEN XT Adverse Event Patients with...

  • Page 101: At Population

    2 years is presented in Table 31 for the AT population. Table 31: All Stroke, Major Vascular Complications, or Aortic Valve Reintervention to 2 Years (AT Population) SAPIEN XT (N = 994) SAVR (N = 944) Relative Risk Events/Patients Events/Patients...
  • Page 102 Table 33: Key CEC-Adjudicated Adverse Events (ITT Population) SAPIEN XT SAVR Overall TF Access Non-TF Access (N = 1021) (N = 1011) (N = 775) (N = 236) 30 Days Acute kidney injury 192 (19.0) 106 (13.7) 86 (36.4) 327 (32.0) Stage III 13 (1.3)

  • Page 103: At Population

    0.7% at 30 days, 0.3% at 1 year, and 0.8% at 2 years. The proportion of patients with aortic PVL ≥ moderate was 3.8% at 30 days, 3.4% at 1 year, and 8.0% at 2 years in the SAPIEN XT arm, as compared to 0.5% at 30 days, 0.3% at 1 year, and 0.6% at 2 years in the SAVR arm.
  • Page 104 Figure 29: Mean Gradient (VI Population) Figure 30: Peak Gradient (VI Population)

  • Page 105: At Population

    SAVR NYHA The NYHA classifications by visit are presented in Figure 33. In the SAPIEN XT AT population, 78% of the patients were in NYHA Class III or IV at baseline, which reduced to 11% at 30 days, 8% at 1 year, and 10% at 2 years, while in the SAVR AT population, the percentage of patients in NYHA Class III or IV was 76% at baseline, 14% at 30 days, 7% at 1 year, and 7% at 2 years.

  • Page 106: At Population

    Figure 33: NYHA Class (AT Population) Figure 34: NYHA Class- TF versus non-TF Access (AT Population) Baseline 30 Day 6 Month 1 Year 2 Years Baseline 30 Day 6 Month 1 Year 2 Years Non-TF...

  • Page 107: At Population

    Length of Stay (LoS) The results for LoS are presented in Table 34. Overall, the SAPIEN XT patients had shorter LoS' than the SAVR patients. Table 34: Length of Stay (AT Population) SAPIEN XT Length of SAVR Stay (days) Non-TF Overall 7.4±5.6...

  • Page 108: At Population

    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)

  • Page 109: At Population

    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 measures are presented in Tables 35 and 36, respectively. Table 35: EQ-5D Utilities Score (AT Population) SAPIEN XT EQ-5D Utilities Score SAVR Non-TF Baseline 0.7±0.2 0.7±0.2...
  • Page 110 No. 6,214,054; 6,547,827; 6,908,481; 7,214,344; 7,510,575; 7,530,253; 7,585,321; 7,780,723; 7,846,203; 7,895,876; 7,993,394; 8,057,540; 8,382,826; 8,591,575; 8,690,936; 8,790,387; 9,301,840; and 9,301,841; and corresponding foreign patents. Additional patents are pending. 08/2016 ©Copyright 2016, Edwards Lifesciences LLC All rights reserved. Manufacturer Web IFU...

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