9
Results
Technical Success:
Successful deployment of the device, or the successful completion of the
surgical procedure.
Procedure Success:
Successful closure of the defect as measured immediately following the
procedure (less than or equal to 2 mm residual shunt).
Composite Success:
All device placement attempts without a major adverse event, surgical
reintervention, embolization, technical failure, or major shunt (defined as greater than 2 mm).
Closure Success:
Among patients that were technical successes, closure of the atrial septal
defect (defined as a shunt less than or equal to 2 mm) without the need for surgical repair.
Major Adverse Events:
Events that are life threatening, prolong hospitalization, or have long term
consequences or need for ongoing therapy. These include but are not limited to cerebral
embolism, cardiac perforation with tamponade, endocarditis, pericardial effusion with tamponade,
repeat surgery, death, cardiac arrhythmias requiring permanent pacemaker placement or long
term anti-arrhythmia medication, and device embolizations requiring immediate surgical removal.
Minor Adverse Events:
Device embolization with percutaneous retrieval, cardiac arrhythmia with
treatment, phrenic nerve injury, hematoma, other vascular access site adverse events,
retroperitoneal hematoma, surgical wound adverse events, other procedural adverse events,
pericardial effusion requiring medical management, evidence of device associated thrombus
formation without embolization (with or without treatment), and marker band embolization without
known sequelae.
Table 5. Principal Effectiveness and Safety Results — Pivotal Study
AMPLATZER™
Patients
a
a. Unit of analysis = Patient. Although 10 patients had 2 defects each treated with an
AMPLATZER™ Septal Occluder, all patients with multiple AMPLATZER™ implants were
successfully treated.
Surgical Control
Patients
90% Confidence
Interval
Technical Success
423/442 (95.7%)
154/154 (100%)
(-0.084, -0.010)
Procedure Success
413/423 (97.6%)
154/154 (100%)
(-0.059, +0.008)
Early (30 days) Composite Success
401/442 (90.7%)
148/154 (96.1%)
(-0.096, +0.019)
12-month Composite Success
331/362 (91.4%)
146/154 (94.8%)
(-0.153, -0.033)
24-hour Closure Success
404/418 (96.7%)
154/154 (100%)
(-0.073, -0.001)
6-month Closure Success
376/387 (97.2%)
154/154 (100%)
(-0.068, +0.003)
12-month Closure Success
326/331 (98.5%)
149/149 (100%)
(-0.052, 0.017)
Principal Safety Measures
Major Adverse Events 12-months
7/442 (1.6%)
8/154 (5.2%)
(-0.090, -0.002
Minor Adverse Events 12-months
27/442 (6.1%)
29/154 (18.8%)
(-0.200, -0.070)
12-month Composite Success (K-M)
0.934
0.938
[-0.044, +0.036]
Survival at 30 days (K-M)
0.939
0.956
[-0.052, +0.036]
Survival at 180 days (K-M)
0.936
0.947
[-0.048, +0.026]
100092311_ASD.book Page 9 Monday, January 6, 2014 11:00 AM
