APPENDIX 1
ICE: Echo Core Lab-CRF Study #: - Pt Initials: 1. Date of study: / / D D M M M Y Y Y Y 2. Type of Study: TTE TEE 3. Quality of Study: Poor Moderate Excellent Ejection Fraction 4. Ejection Fraction (to nearest 5%) % LV Dimensions (PLAX if TTE, transgastric if TEE) 5. End Systolic mm 6. End Diastolic mm Valve Status 7. Mitral Valve: Native Native Plus Ring Biosprosthetic Mechanical N/E 8. Aortic Valve: Native Native Plus Ring Biosprosthetic Mechanical N/E 9. Tricuspid Valve: Native Native Plus Ring Biosprosthetic Mechanical N/E 10. Pulmonic Valve: Native Native Plus Ring Biosprosthetic Mechanical N/E Regurgitation 11. Mitral Regurg: None or trace Mild Moderate Severe N/E 12. Aortic Regurg: None or trace Mild Moderate Severe N/E 13. Tricuspid Regurg: None or trace Mild Moderate Severe N/E 14. Pulmonic Regurg: None or trace Mild Moderate Severe N/E Stenosis 15. Mitral Stenosis: None or trace Mild Moderate Severe N/E 16. Aortic Stenosis: None or trace Mild Moderate Severe N/E 17. Tricuspid Stenosis: None or trace Mild Moderate Severe N/E 18. Pulmonic Stenosis: None or trace Mild Moderate Severe N/E Vegetations: Present? Oscillating? 19. Mitral Vegetation: No Possible Definite N/E 20. Yes No N/A 21. Aortic Vegetation: No Possible Definite N/E 22. Yes No N/A 23. Tricuspid Vegetation: No Possible Definite N/E 24. Yes No N/A 25. Pulmonic Vegetation: No Possible Definite N/E 26. Yes No N/A 27. IC Device: No Possible Definite N/E 28. Yes No N/A 29. IC Catheter: No Possible Definite N/E 30. Yes No N/A 31. IC other: No Possible Definite N/E 32. Yes No N/A 33. if other please list : Page 1 of 3 ICE Echo CRF 1.1 Created 18 March 2004
ICE: Echo Core Lab-CRF Study #: - Pt Initials: Vegetation Site (if native valve): (Please check all that apply) 34. Mitral Site: Anterior Leaflet Posterior Leaflet Unknown 35. Aortic Site: Right Cusp Left Cusp Non coronary Unknown Largest Vegetation Size 36. Mitral: mm X mm OR N/A 37. Aortic: mm X mm OR N/A 38. Tricuspid: mm X mm OR N/A 39. Pulmonic: mm X mm OR N/A 40. IC Device: mm X mm OR N/A 41. IC Catheter: mm X mm OR N/A 42. Other: mm X mm OR N/A Complications (Please check all that apply) 43. Perforation: Mitral Aortic Tricuspid Pulmonic N/A 44. Abscess: Mitral Aortic Tricuspid Pulmonic N/A 45. Fistulous Tract origin: Mitral Aortic Tricuspid Pulmonic N/A 46. If fistulous tract: Please list exact origin: 47. If fistulous tract: Please list exact end: Prosthetic Perivalvular Complication (Please check all that apply) 48. Dehiscence: Mitral Aortic Tricuspid Pulmonic N/A 49. Perivalvular Regurgitation: Mitral Aortic Tricuspid Pulmonic N/A Characterization of Largest Vegetation Characterization Grade 50. Mobility: 1 2 3 4 N/A 51. Extent: 1 2 3 4 N/A 52. Consistency: 1 2 3 4 N/A Page 2 of 3 ICE Echo CRF 1.1 Created 18 March 2004
ICE: Echo Core Lab-CRF Study #: - Pt Initials: Congenital Heart Disease 53. Prior Congenital Disease: Yes No unknown If Yes, Check Type (If no, skip to Question 61) 54. ASD : Yes No 55. VSD : Yes No 56. Bicuspid AV: Yes No 57. IHSS/HCM: Yes No 58. Complex Congenital Heart Disease: Yes No 59. Surgically Created Shunt: Yes No 60. Other Congenital: Yes No Acquired Heart Disease (Please check all that apply) 61. Mitral Valve: Rheumatic Thickened Calcified Prolapse MAC N/A unknown 62. Aortic Valve: Rheumatic Thickened Calcified Prolapse N/A unknown 63. Tricuspid Valve: Rheumatic Thickened Calcified Prolapse N/A unknown 64. Pulmonic Valve: Rheumatic Thickened Calcified Prolapse N/A unknown Name of Physician (printed): Name of Reader (printed), if different than Physician: Physician Signature: Date: / / d d m m m y y y y Page 3 of 3 ICE Echo CRF 1.1 Created 18 March 2004
ICE Echo Instructions / Definitions Please note that an ECHO CRF can be completed for both a TTE and a TEE. Item 1: Items 2-3: Date of Study Please enter as dd / mmm / yyyy, example 22 / FEB / 2004 TTE = Transthoracic Echocardiogram TEE = Transesophageal Echocardiogram Item 4: Please provide ejection fraction, by visual estimate, rounded to the nearest 5% Items 5-6: Items 7-10: Items 11-14: Please provide the LV dimensions either form the TTE parasternal long axis view (PLAX) or from the TEE transgastric long axis view. N/E = not evaluable. For the purposes of this from, a homograft should be considered a bioprosthetic valve. N/E = not evaluable For regurgitation, please use the following definitions: Jet ht/lvot ht (PLAX) Pressure half-time Holodiastolic flow reversal desc aorta Aortic valve Mild <30% >400 msec Moderate 30-60% 200-400 msec Severe >60% <200 msec ++ Regurgitant jet area/la area Mitral valve Mild 10-20% Moderate 20-40% Severe >40% Regurgitant Jet Area/RA area Tricuspid valve Mild <20% Moderate 20-34% Severe >34% Pulmonary valve Mild 1-2 cm in length and holodiastolic in duration Moderate or Severe (clinically significant): > 2 cm in length with peak velocity > 1.5 m/s, holodiastolic in duration Page 1 of 4 ICE Echo Definitions 1.1 Created 15 March 2004
ICE Echo Instructions / Definitions Items 15-18: N/E = not evaluable For stenosis, please use the following definitions: Peak velocity/gradient Mean gradient Valve area PT1/2 Aortic valve Mild 2-3 m/s / 16 36 mm Hg < 30 mm Hg 1.5-2 Moderate 3-4 m/s / 36-64 mm Hg 30-50 mm Hg 1.0-1.5 Severe > 4 m/s / > 64 mm Hg > 50 mm Hg < 1.0 Mitral valve Mild < 5 mm Hg 1.5-2.3 90-150 msec Moderate 6-12 mm Hg 1.0-1.5 150-219 msec Severe > 12 mm Hg <1.0 >220 msec Tricuspid valve Mild Moderate Severe < 2 mm Hg 2-6 mm Hg > 6 mm Hg Pulmonary valve Mild Moderate Severe 5-30 mm Hg 30-64 mm Hg > 64 mm Hg Items 19-33: N/E = not evaluable IC = intracardiac Please use the following definitions: Vegetation: Definite vegetation: Irregularly shaped discrete echogenic masses adherent to, yet distinct from, cardiac surfaces including valve structures, myocardium, and intracardiac devices. Possible vegetation: echogenic mass, not fully meeting criteria for definite vegetation Oscillation: Masses with high frequency movement independent of the associated valvular motion. Items 34-35: Items 36-42: Items 43-45: Item 43: Please check all that apply. Please measure the largest dimensions of the vegetation in two orthogonal views (right angle to one another). Please check all that apply Please use the following definition for perforation: Perforation: Evidence of blood flow through a valve structure at a point that does not include the valve orifice. Page 2 of 4 ICE Echo Definitions 1.1 Created 15 March 2004
ICE Echo Instructions / Definitions Item 44: Please use the following definition for abscess: Abscess: Thickened areas or masses within the myocardium or annular region with a non-homogeneous echogenic or echolucent appearance. The presence of blood flow within the thickened space as visualized by color flow imaging is considered supporting evidence for abscess formation but not necessary for definition. Item 45: Please use the following definition for fistula: Fistula: Abnormal connection between 2 distinct reservoirs such as aorta and an atrium. Items 46-47: Only answer if fistula tract was documented in Item 45. Items 48-49: Item 48: Please check all that apply Please use the following definition for dehiscence: Dehiscence: Rocking motion of the prosthetic valve with excursion greater than 15 o in at least one direction. Item 49: Please use semi-quantitative methods and clinical experience to quantitate the amount of perivalvular regurgitation using the valvular regurgitation definitions above. Largest Vegetation Characterization: (Sanfilippo JACC 18(5):1191-1199, 1991) Item 50: Please characterize the mobility of the largest vegetation as follows: Mobility: Grade 1: fixed vegetation with no detectable independent motion Grade 2: fixed base, mobile free edge Grade 3: pedunculated (relatively long and thin), stays within chamber Grade 4: prolapsing (moves between 2 chambers during cardiac cycle) Item 51: Please characterize the extent of the largest vegetation as follows: Extent: Grade 1: single vegetation Grade 2: multiple vegetations, limited to single valve leaflet Grade 3: involvement of multiple valve leaflets Grade 4: vegetation extends to extra valvular structures Page 3 of 4 ICE Echo Definitions 1.1 Created 15 March 2004
ICE Echo Instructions / Definitions Item 52: Please characterize the consistency of the largest vegetation as follows: Consistency: Grade 1: completely calcified vegetation Grade 2: partially calcified vegetation Grade 3: no calcification, consistently denser than myocardial echoes Grade 4: consistency equal to myocardial echoes Items 53-60: Items 61-64: Self explanatory. Please use the following definitions: Rheumatic: Increased echogenicity of the leaflet edges, commissural fusion, and restricted valvular mobility. Mitral valve with typical hockey stick appearance. Aortic valve only in presence of mitral valve disease and with doming of leaflets in systole. Calcific: Increased echogenicity of the leaflets, predominantly at the base of the leaflets, without evidence of commissural fusion. In addition, the aortic valve must not be bicuspid (see item 56). Thickened: Abnormally thickened valvular structures not meeting the definitions noted above. Prolapse: Marked displacement of leaflets at valvular closure with coaptation point beyond annular plane. MAC: mitral annular calcification. Page 4 of 4 ICE Echo Definitions 1.1 Created 15 March 2004