1. Review of the Data from the Subclavian Approach Clinical Trials
The Self-Expanding Medtronic CoreValve Transcatheter Valve System:
Review of the Data from the Subclavian Approach Clinical Trials
Raoul Bonan, MD
Institut de Cardiologie de Montreal

2. Presenter Disclosure Information Raoul Bonan, MD
Scientific Advisory Board and/or Consultant
CoreValve/Medtronic
Clinical Research Agreements
Multiple Medical Device Clinical Investigations
Including CoreValve

3. Rationale for Subclavian Approach
Subclavian implantation expands patient access to TAVI
A subclavian approach provides an alternative for TAVI for patients whose iliofemoral anatomy is compromised due to atherosclerosis, calcifications, or tortuosity
Subclavian arteries are often viable in patients with compromised femoral and/or iliac arteries
Petronio AS, De Carlo M, Bedogni F, et al. Safety and efficacy of the subclavian approach for transcatheter aortic valve implantation with the CoreValve Revalving System. Circ Cardiovasc Interv. 2010;3:
Modine T, Obadia JF, Choukroun E, et al. Transcutaneous aortic valve implantation using the axillary/subclavian access: Feasibility and early clinical outcomes. J Thorac Cardiovasc Surg. Apr. 28, [Epub ahead of print]

4. Subclavian as an Alternate Access Point
Provides an alternate access for both cardiac surgeons and interventional cardiologists
Enables implanting teams to mitigate risk by better adapting procedure to patient’s anatomy
Training for subclavian is incremental for both transapical and transfemoral implanters
Subclavian has to be seen as an alternative access that should deeply modify the previous scheme :
Femoral access when feasible and Transapical approach when no femoral access possible
That is true for both operators cardiac surgeons using the transapical access or interventionnal cardiologists using the transfemoral access

5. Height: 169 cm Weight: 89.8 kg BSA: 2 m²
Montreal Subclavian Example
DOB: 29 Apr Referral Origin:
Age: Referral date:
Diagnosis:
Symptomatic severe AS- angina, dyspnea, no syncope
Comorbidities:
Hypertension, dyslipidemia, hypothyroid, emphysema
NSTEMI November 2009, moderate LV dysfunction
Mild chronic renal impairment- 46 mm fusiform AAA
Ex smoker- 2cm lung nodule right apical lobe – CT PET awaited
Hb: 135 g/lPlt: 275 x 109/l
Creat: 122 μmol/l, 1.38 mg/dl
Logistic EuroSCORE : 44.9%
STS score: 8.9 % mortality, 39.7 % morbidity/mortality
NYHA: III-IV
TAVI inclusion criteria: High EuroSCORE , axillary approach proposed
Potential problems with TAVI: Horizontal aorta, borderline large aorta
Surgical opinion: High risk
Height: 169 cm Weight: 89.8 kg BSA: 2 m²

6. TTE November 2009 Aortic annulus 27 mm LVEF: 40-45 %
Calcific aortic stenosis
AVA: cm2 (continuity VTI)
Vmax: 4.7 m/sec
Mean gradient: 49 mmHg
Aortic regurgitation: 1/4
Mitral regurgitation: 1/4
Tricuspid regurgitation: 1/4
Pulmonary regurgitation: -
Estimated RV pressure : 38 mmHg
Septum: 11 mm, post wall 7 mm

7. TTE November 2009

8. MRI November 2009

22. Subclavian as an Advantage
Vs Transapical
Mitigates or eliminates trauma to the heart
Can be done under local anesthesia
Recovery time is faster and lower risk (drainage ports are not needed)
Vs Transfemoral
Bypasses aortic arch
Not limited by femoral vasculature
Able to visually control closure
Better control of delivery catheter and guidewire

23. Subclavian Clinical Experience
Study/Design N
Number of Centers
Dates
Reported
Follow-up
Italian Registry1
102 12
Through July 2010
12 months
PAVR Registry2 79 41
Through April 2009
30 days
French Series3 17 4
Through September 2009
Subclavian clinical experience is currently limited, but is growing rapidly.
Subclavian data presented in this PowerPoint is based on a literature review using the following criteria:
Minimum sample size of 10 patients
Study methods included either prospective enrollment or prospective registration of patients and systematic follow-up
The most recent report was used in cases where the same study population was being followed
Reported subject numbers may represent some overlap between patient populations
Data from published articles and presentations at scientific meetings has been included
De Carlo M. Safety and efficacy of the subclavian access for TAVI with the CoreValve bioprosthesis: the initial 102 patients. Presented at ESC Aug. 28-Sept. 1, Stockholm, Sweden.
Laborde JC. Aortic valve implantation by subclavian access site. Presented at EuroPCR09. May 19-22, Barcelona, Spain.
Modine T, Obadia JF, Choukroun E, et al. Transcutaneous aortic valve implantation using the axillary/subclavian access: Feasibility and early clinical outcomes. J Thorac Cardiovasc Surg. Apr. 28, [Epub ahead of print]

24. Baseline Clinical Characteristics
Subclavian Approach1-3
Transfemoral Experience4
Age (years)
Range: 71 to 83 years
Range: 78 to 83 years
Female
Range: 38% to 54%
Range: 27% to 65%
NYHA Class III and IV
Range: 40% to 75.6%
68%
74.6%*
Mean Logistic EuroSCORE (%)
Range: 27.3% to 34%
Range: 15% to 28.2%
*18Fr S&E Study
De Carlo M. Safety and efficacy of the subclavian access for TAVI with the CoreValve bioprosthesis: the initial 102 patients. Presented at ESC Aug. 28-Sept. 1, Stockholm, Sweden.
Laborde JC. Aortic valve implantation by subclavian access site. Presented at EuroPCR09. May 19-22, Barcelona, Spain.
Modine T, Obadia JF, Choukroun E, et al. Transcutaneous aortic valve implantation using the axillary/subclavian access: Feasibility and early clinical outcomes. J Thorac Cardiovasc Surg. Apr. 28, [Epub ahead of print]
See References slides for sources.

25. Procedural Details: Subclavian Approach
Mean procedure time
(min)
Fluoroscopy time (min)
Local anesthesia
Italian Registry1
N=102
103 ± 31
24 ± 11
42.2%
PAVR Registry2
N=79
168.7 ± 50.8
Not reported
French Series3
N=17
23.5%
De Carlo M. Safety and efficacy of the subclavian access for TAVI with the CoreValve bioprosthesis: the initial 102 patients. Presented at ESC Aug. 28-Sept. 1, Stockholm, Sweden.
Laborde JC. Aortic valve implantation by subclavian access site. Presented at EuroPCR09. May 19-22, Barcelona, Spain.
Modine T, Obadia JF, Choukroun E, et al. Transcutaneous aortic valve implantation using the axillary/subclavian access: Feasibility and early clinical outcomes. J Thorac Cardiovasc Surg. Apr. 28, [Epub ahead of print] 25

26. Procedural Success
De Carlo M. Safety and efficacy of the subclavian access for TAVI with the CoreValve bioprosthesis: the initial 102 patients. Presented at ESC Aug. 28-Sept. 1, Stockholm, Sweden.
Laborde JC. Aortic valve implantation by subclavian access site. Presented at EuroPCR09. May 19-22, Barcelona, Spain.
Modine T, Obadia JF, Choukroun E, et al. Transcutaneous aortic valve implantation using the axillary/subclavian access: Feasibility and early clinical outcomes. J Thorac Cardiovasc Surg. Apr. 28, [Epub ahead of print].
See References slides for sources.

27. Transfusion (in hospital)
Bleeding
Transfusion (in hospital)
Bleeding
Italian Registry1
N=102
≥ 2 units: 7.8%
≥ 5 units: 2.9%
Not reported
PAVR Registry2
24-Hour N=79
30-Day N=53
Access site: 1.3%
Major bleeding: 1.3%
Access site: 1.9%
Major bleeding: 3.8%
French Series3
N=17
≤ 2 units: 43%
De Carlo M. Safety and efficacy of the subclavian access for TAVI with the CoreValve bioprosthesis: the initial 102 patients. Presented at ESC Aug. 28-Sept. 1, Stockholm, Sweden.
Laborde JC. Aortic valve implantation by subclavian access site. Presented at EuroPCR09. May 19-22, Barcelona, Spain.
Modine T, Obadia JF, Choukroun E, et al. Transcutaneous aortic valve implantation using the axillary/subclavian access: Feasibility and early clinical outcomes. J Thorac Cardiovasc Surg. Apr. 28, [Epub ahead of print]

28. Vascular Complications
De Carlo M. Safety and efficacy of the subclavian access for TAVI with the CoreValve bioprosthesis: the initial 102 patients. Presented at ESC Aug. 28-Sept. 1, Stockholm, Sweden.
Laborde JC. Aortic valve implantation by subclavian access site. Presented at EuroPCR09. May 19-22, Barcelona, Spain.
Modine T, Obadia JF, Choukroun E, et al. Transcutaneous aortic valve implantation using the axillary/subclavian access: Feasibility and early clinical outcomes. J Thorac Cardiovasc Surg. Apr. 28, [Epub ahead of print]
See References slides for sources.

29. 30-Day All-Cause Mortality
Laborde JC. Aortic valve implantation by subclavian access site. Presented at EuroPCR09. May 19-22, Barcelona, Spain.
Modine T, Obadia JF, Choukroun E, et al. Transcutaneous aortic valve implantation using the axillary/subclavian access: Feasibility and early clinical outcomes. J Thorac Cardiovasc Surg. Apr. 28, [Epub ahead of print]

30. Improved NYHA Class at 30 Days
*Includes cases with follow-up data between 1 month and 5 months.
Petronio AS, De Carlo M, Bedogni F, et al. Safety and efficacy of the subclavian approach for transcatheter aortic valve implantation with the CoreValve Revalving System. Circ Cardiovasc Interv. 2010;3:
Laborde JC. Aortic valve implantation by subclavian access site. Presented at EuroPCR09. May 19-22, Barcelona, Spain.
See References slides for sources.

31. Mean Gradients Mean Gradients Baseline 30 Days PAVR Registry1 52.7 Hg
French Series2
N=17
47 Hg ± 13.3
7.9 Hg ± 4.1
Transfemoral Experience3
Not reported
8.5 to 11.0 Hg
*Includes cases with follow-up data between 1 month and 5 months.
Laborde JC. Aortic valve implantation by subclavian access site. Presented at EuroPCR09. May 19-22, Barcelona, Spain.
Modine T, Obadia JF, Choukroun E, et al. Transcutaneous aortic valve implantation using the axillary/subclavian access: Feasibility and early clinical outcomes. J Thorac Cardiovasc Surg. Apr. 28, [Epub ahead of print]
See References slides for sources.

32. Valvuloplasty after PAVR
Paravalvular Leak
Valvuloplasty after PAVR
PAVR
Italian Registry1
N=102
10.8%
Not reported
French Series2
N=17
11.8%
Grade 0-1: 82.4%
Grade ≥ 3: 0%
De Carlo M. Safety and efficacy of the subclavian access for TAVI with the CoreValve bioprosthesis: the initial 102 patients. Presented at ESC Aug. 28-Sept. 1, Stockholm, Sweden.
Modine T, Obadia JF, Choukroun E, et al. Transcutaneous aortic valve implantation using the axillary/subclavian access: Feasibility and early clinical outcomes. J Thorac Cardiovasc Surg. Apr. 28, [Epub ahead of print]

33. MACCEs at 30 Days
Italian Registry data is reported as the in-hospital rate.
De Carlo M. Safety and efficacy of the subclavian access for TAVI with the CoreValve bioprosthesis: the initial 102 patients. Presented at ESC Aug. 28-Sept. 1, Stockholm, Sweden.
Modine T, Obadia JF, Choukroun E, et al. Transcutaneous aortic valve implantation using the axillary/subclavian access: Feasibility and early clinical outcomes. J Thorac Cardiovasc Surg. Apr. 28, [Epub ahead of print]
See References slides for sources.

34. TIA and Stroke at 30 Days
Italian Registry data is reported as the in-hospital rate.
De Carlo M. Safety and efficacy of the subclavian access for TAVI with the CoreValve bioprosthesis: the initial 102 patients. Presented at ESC Aug. 28-Sept. 1, Stockholm, Sweden.
Laborde JC. Aortic valve implantation by subclavian access site. Presented at EuroPCR09. May 19-22, Barcelona, Spain.
Modine T, Obadia JF, Choukroun E, et al. Transcutaneous aortic valve implantation using the axillary/subclavian access: Feasibility and early clinical outcomes. J Thorac Cardiovasc Surg. Apr. 28, [Epub ahead of print]

35. Permanent Pacemaker at 30 Days
*The rate of pacemaker implantation using the transfemoral approach (9%-28.6%) is similar to the rate experienced with the subclavian approach (10.1% %) except for a higher percentage (59%) for the transfemoral approach reported at a single implanting center in Germany (Gotzmann, et. al). See the References slides for the source.
Italian Registry data is reported as the in-hospital rate.
*See the notes section for further information on the pacemaker implantation rate.
De Carlo M. Safety and efficacy of the subclavian access for TAVI with the CoreValve bioprosthesis: the initial 102 patients. Presented at ESC Aug. 28-Sept. 1, Stockholm, Sweden.
Laborde JC. Aortic valve implantation by subclavian access site. Presented at EuroPCR09. May 19-22, Barcelona, Spain.
See References slide for sources.

36. Freedom from MAVREs at 6 Months
*Does not include the 18Fr S&E Study.
Petronio AS, De Carlo M, Bedogni F, et al. Safety and efficacy of the subclavian approach for transcatheter aortic valve implantation with the CoreValve Revalving System. Circ Cardiovasc Interv. 2010;3:
See References slides for sources.

37. Overall Survival
De Carlo M. Safety and efficacy of the subclavian access for TAVI with the CoreValve bioprosthesis: the initial 102 patients. Presented at ESC Aug. 28-Sept. 1, Stockholm, Sweden. 37

38. Conclusions
Initial clinical results demonstrate that subclavian implantation of the CoreValve System is safe and effective
Procedure can be successfully performed in the cath lab and in some cases under local anesthesia
High procedural success with low rates of vascular and bleeding complications
Positive hemodynamic and functional outcomes comparable to transfemoral implantation
Positive survival, improvements in mean gradient and NYHA class
Subclavian approach to CoreValve device implantation has the potential to expand patient access
CAUTION: For distribution only in markets where CoreValve® has been approved. The CoreValve® System is not currently approved in the USA, Japan or Canada.
CoreValve is a registered trademark of Medtronic CV Luxembourg S.a.r.l.
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©Medtronic, Inc. 2011
All Rights Reserved

40. References
Attias D, Himbert D, Ducrocq G, Détaint D, et al. Immediate and mid-term results of transfemoral aortic valve implantation using either the Edwards Sapien™ transcatheter heart valve or the Medtronic CoreValve® System in high-risk patients with aortic stenosis. Arch Cardiovasc Dis. 2010;103: Avanzas P, Muñoz-Garcia AJ, Segura J., Pan M, et al. Percutaneous implantation of the CoreValve® self-expanding aortic valve prosthesis in patients with severe aortic stenosis: early experience in Spain. Rev Esp Cardiol. 2010;63(2): Baan J, Yong ZY, Koch KT, Henriques JPS, et al. Percutaneous implantation of the CoreValve aortic valve prosthesis in patients at high risk or rejected for surgical valve replacement. Neth Heart J. 2010;18(1): Bleiziffer S, Ruge H, Mazzitelli D, Schreiber C, et al. Results of percutaneous and transapical transcatheter aortic valve implantation performed by a surgical team. Eur J Cardiothorac Surg. 2009;35(4): ; discussion Fr Safety and Efficacy Report. COR Medtronic. Data on file.* *The 18Fr S&E study includes two patients implanted via a subclavian approach.

41. References
Gotzmann M, Hehen T, Germing A, Lindstaedt M, et al. Short-term effects of transcatheter aortic valve implantation on neurohormonal activation, quality of life and 6-minute walk test in severe and symptomatic aortic stenosis. Heart. 2010;96: ; published online November 1, 2009; doi: /hrt
Grube E, Schuler G, Buellesfeld L, Gerckens U, et al. Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome. J Am Coll Cardiol. 2007;50(1):69-76.
John D, Buellesfeld L, Yuecel S, Mueller R, et al. Correlation of device landing zone calcification and acute procedural success in patients undergoing transcather aortic valve implantations with the self-expanding CoreValve prosthesis. JACCCardiovasc Interv. 2010;3(2):
Otten AM, van Domburg RT, van Gameren M, Kappetein AP, et al. Population characteristics, treatment assignment and survival of patients with aortic stenosis referred for percutaneous valve replacement. EuroIntervention. 2008;4(2):
Piazza N, Grube E, Gerckens U, den Heijer P, et al. Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr) corevalve revalving system: results from the multicentre, expanded evaluation registry 1-year following CE mark approval. EuroIntervention. 2008;4(2):

42. References
Tamburino C, Capodanno D, Mulè M, Scarabelli M, et al. Procedural success and 30-day clinical outcomes after percutaneous aortic valve replacement using current third-generation self-expanding CoreValve prosthesis. J Invasive Cardiol. 2009;21(3): Tchetche D, Dumonteil N, Sauguet A, Descoutures F, et al. Thirty-day outcome and vascular complications after transarterial aortic valve implantation using both Edwards SAPIEN™ and Medtronic CoreValve® bioprostheses in a mixed population. EuroIntervention. 2010;5: Tzikas A, Piazza N, Geleijnse ML, Van Mieghem N, et al. Prosthesis-patient mismatch after transcather aortic valve implantation with the Medtronic CoreValve system in patients with aortic stenosis. Am J Cardiol. 2010;106: