Data Summary and Statistical Information

A. Data Summary

Entries through 3/31/95
Centers submitting data: 38
Procedures submitted and entered into the database: 535
Patients entered into the database: 523 (12 patients have 2 procedures submitted)

B. Patient Demographic Information

AGE: 15 days - 71 years, mean age 3 years, 5 months

MURMURS
Continuous	Systolic	None/Functional
389	96	46

SYMPTOMS
None	CHF	SBE
467	47	3*

* total 4 episodes

C. Prior or Concomitant Procedures

Prior or Concomitant Procedures
Procedure	Number
PDA Ligation	14
Rashkind Device	13
PDA Coil	12
ASD repair	6
VSD repair	4
Coarc. Angioplasty	3
Pulm, Valvuloplasty	3
RF Ablation	2
PAPVR repair	2
Senning	1
TAPVR repair	1
Aortic Valvuloplasty	1
Sub AS repair	1
ASD Clamshell	1
AV Canal repair	1

D. PDA Type

PDA TYPE
TYPE	Number
A	331
B	49
C	41
D	30
E	84

E. PDA Size

PDA SIZE
Size	Number
less than 1mm	113
1-2mm	209
2-3 mm	136
3-4 mm	53
more than 5mm	6

range = less than 1mm to 7mm
median = 2.0mm

F. Procedural Information

Anesthesia: local/sedation: 434 general: 101
Heparinzation: yes: 434; no: 99
Antibiotics given: yes: 509; no: 26
Catheter size: 3F:7; 4F:118; 4.5-5F: 348; 5.2-5.5F:47; 6F:9
Admission Type: outpatient: 299 (duration 6 +/-2 hours); inpatient 229 (duration 1.1 +/- 0.4 days)

G. Coil Embolization and Retrival

428 procedures without coil migration or retrieval; coils embolized but not retrieved: 16 in 14 patients (1 in a splenic artery branch, 15 in pulmonary arteries); coils retrieved: from pulmonary arteries: 67 in 51 patients, from systemic arteries: 17 in 13 patients, from the PDA 61 in 38 patients (not stable or position judged unsatisfactory).

H. Coils Implanted

Single coil (helical diameter): 1mm:1; 2-2.5mm: 18; 3mm:117; 4mm:9; 5mm:197; 8mm:34; 10mm:1.
Multiple coils implanted: 128
No coils implanted: 29 (4 patients had coils implanted at a second procedure)

I. Acute Results (Registry contains only acute data)

Complete success defined as no residual shunt by Doppler echo within 24 hours of procedure. If echo not done or results not reported, success defined as no shunt by angiography. Partial success defined as any degree of residual shunt by Doppler, or by angiography if echo not done. Failure defined as patient left cath lab without a coil in the PDA (in the case of second procedures, without a new coil in the PDA)
Complete success: 401 (75%)
Partial success: 105 (20%)
Failure: 29 (5%)

Results by PDA Type

Results by PDA Type
PDA TYPE	complete success	partial success	failure
A	228	69	10
B	26	8	9
C	31	5	4
D	24	6	0
E	64	12	5

Relationship between PDA type and failure is significant (p less than 0.001), with failure more common in type B and less common in type A than the overall average.

Success by Helical Diameter of Implanted Coils

Success by Helical Diameter of Implanted Coils
Coil Size (mm)	Complete Success	Partial Success
3	106	11
5	145	52
8	19	15
multiple	104	24

Relationship between implanted coil size and degree of success is significant (p less than 0.001), with results better with single 3mm coils, and worse with single 8mm coils than with single 5mm coils or multiple coils.

Results by PDA Size

RESULTS BY PDA SIZE
Complete success	Partial success	Failure
1.9 +/- 1.0mm	2.4 +/- 1.0mm	2.9 +/- 1.2mm

p less than 0.0001 by ANOVA

J. Complications (excluding coil migration, retrieval, failure)

Complications
Complication	Number
None	488
Reduced Pulse	6
Hematoma	5
Fever	3
Oversedation requiring treatment	2
Transfusion	1
Contrast Allergy	1
Protamine allergy	1

Return to Home Page