This appendix has been provided by the authors to give readers additional information about their work.
Supplement to: Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in
patients who cannot undergo surgery. N Engl J Med 2010;363:1597-607. DOI: 10.1056/NEJMoa1008232.
(PDF updated November 16, 2010.)
TABLES AND FIGURES (SUPPLEMENTARY APPENDIX)
Table 1: PARTNER Inclusion and Exclusion Criteria
1. Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient >
40 mm Hg or jet velocity > 4.0 m/s or an aortic valve area (AVA) of < 0.8 cm2 (or AVA index
< 0.5 cm2/m2).
Symptomatic due to aortic valve stenosis as demonstrated by NYHA Functional Class ≥ II.
The subject or the subject’s legal representative was informed of the nature of the study, agreed to
its provisions and provided written informed consent as approved by the Institutional Review Board
of the respective clinical site.
4. The subject and the treating physician agreed that the subject would return for all required post-
procedure follow-up visits.
5. The subject, after formal consults by a cardiologist and two cardiovascular surgeons agreed that
medical factors precluding operation, based on a conclusion that the probability of death or serious,
irreversible morbidity exceeded the probability of meaningful improvement. Specifically, the
probability of death or serious, irreversible morbidity exceeded 50%. The surgeons' consult notes
should specify medical or anatomic factors leading to that conclusion and included should be a
printout of the STS score calculation to further identify the risks in these patients.
Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment (defined as Q
wave MI, or non-Q wave MI with total CK elevation ≥ twice normal in the presence of CK-MB
elevation and/or troponin level elevation (WHO definition).
2. Aortic valve was a congenital unicuspid or congenital bicuspid valve, or was non-calcified.
3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic
4. Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6
months if the procedure was a drug eluting coronary stent implantation).
5. Pre-existing prosthetic heart valve in any position, prosthetic ring, severe mitral annular calcification,
or severe (greater than 3+) mitral regurgitation
6. Blood dyscrasias as defined: leukopenia (WBC < 3000 mm3), acute anemia (Hb < 9 mg%),
thrombocytopenia (platelet count < 50,000 cells/mm³), history of bleeding diathesis or coagulopathy.
7. Untreated clinically significant coronary artery disease requiring revascularization.
8. Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices.
9. Need for emergency surgery for any reason.
10. Hypertrophic cardiomyopathy with or without obstruction.
11. Severe ventricular dysfunction with LVEF < 20%.
12. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
13. Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months.
14. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel
(Plavix), or sensitivity to contrast media, which cannot be adequately pre-medicated.
15. Native aortic annulus size < 18mm or > 25mm as measured by echocardiogram.
16. Recent (within 6 months) cerebrovascular accident or transient ischemic attack.
17. Renal insufficiency (creatinine > 3.0mg/dL) and/or end stage renal disease requiring chronic
18. Life expectancy < 12 months due to non-cardiac co-morbid conditions.
19. Significant abdominal or thoracic aorta disease, including aneurysm (defined as maximal luminal
diameter 5cm or greater), marked tortuosity (hyperacute bend), aortic arch atheroma (especially if
thick [> 5 mm], protruding or ulcerated), narrowing of the abdominal aorta (especially with
calcification and surface irregularities), or severe “unfolding” and tortuosity of the thoracic aorta
20. Iliofemoral vessel characteristics that would preclude safe placement of 22F or 24F introducer
sheath such as severe calcification, severe tortuosity or vessels size diameter < 7 mm for 22F
sheath or < 8mm for 24F sheath.
21. Currently participating in an investigational drug or another device study.
22. Active bacterial endocarditis or other active infections.
23. Bulky calcified aortic valve leaflets in close proximity to coronary ostia.
AVA denotes aortic valve area, Hb hemoglobin, LVEF left ventricular ejection fraction, MI myocardial
infarction, NYHA New York Heart Association, STS Society of Thoracic Surgeons, WBC white blood cells.
Table 2: PARTNER Study Organization
Executive Committee M.B. Leon, (Co-Principal Investigator), Columbia University Medical Center, New
York; C. Smith, (Co-Principal Investigator), Columbia University Medical Center, New
York; M. Mack, Medical City Dallas, Dallas; D.C. Miller, Stanford University Medical
Center, Palo Alto; J. Moses, (Co-Chairman, Publication Committee), Columbia
University Medical Center, New York; L. Svensson, (Co-Chairman, Publication
Committee), Cleveland Clinic Foundation, Cleveland; M. Tuzcu, Cleveland Clinic
Foundation, Cleveland; J. Webb, St. Paul’s Hospital, Vancouver, BC.
Site monitoring Edwards Lifesciences, LLC, Irvine, CA: N. Cohen (Director); Bright Pharmaceutical
Services, Inc., Sherman Oaks, CA.
Electronic Database RAVE, Medidata Systems, New York, NY.
Data management Edwards Lifesciences, LLC, Irvine, CA: G. Dziem (Director); W.N. Anderson
(Consultant), Lake Forest, CA.
Biostatistics London School of Hygiene and Tropical Medicine: S. Pocock, D. Wang;
W.N. Anderson (Consultant), Lake Forest, CA.
DSMB J. Carrozza (Chairman), Harvard Medical School, Boston, MA; Committee
Members: A. Wechsler, Philadelphia, PA; B. Carabello, Houston, TX; E. Peterson,
Durham, NC; K. Lee, Durham, NC.
Safety Officer Edwards Lifesciences, LLC, Irvine, CA: S. Bartus ( Manager)
CEC J. Petersen (Chairman), Duke Clinical Research Institute, Durham, NC
and ECG Core Lab.
P. Douglas (Principal Investigator), Duke Clinical Research Institute, Durham, NC.
Economic and Quality
of Life Core Lab.
D. Cohen (Principal Investigator), Mid-America Medical Center, Kansas; M.
Reynolds (Director), Harvard Clinical Research Institute, Boston, MA. and St. Luke’s
Medical Center, Kansas City, MO.
CEC denotes clinical events committee, DSMB data safety monitoring board, ECG electrocardiogram,