27
Table 14:
Summary of Failed Bioprosthetic Surgical Valves
Attempted Implant Population
Results
1
(N=197)
Type of Failed Surgical Valve
Bioprosthesis
184 / 195 (94.4%)
Homograft
9 / 195 (4.6%)
Other
2
2 / 195 (1.0%)
Reason for Valve Replacement
Mixed Lesion
45/192 (23.4%)
Insufficiency/regurgitation Only
43/192 (22.4%)
Stenosis Only
104/192 (54.2%)
1
Categorical data are expressed as no./total no. (%).
2
Other includes an unidentified manufactured tissue valve and a St. Jude mechanical composite.
Table 15:
All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe
Paravalvular Leak
Valve Implant Population
30 Days
(N=195)
1 Year
(N=96)
Events
Patients with
Event
95% Confidence
Interval
3
Patients with
Event
95% Confidence
Interval
Composite Event
1
28/166 (16.9%)
[11.5%, 23.4%]
27/71 (38.0%)
[26.8%, 50.3%]
All-Cause Mortality
8/195 (4.1%)
[1.8%, 7.9%]
19/96 (19.8%)
[12.4%, 29.2%]
All Stroke
5/195 (2.6%)
[0.8%, 5.9%]
3/96 (3.1%)
[0.6%, 8.9%]
Moderate or Severe Obstruction
2
12/169 (7.1%)
[3.7%, 12.1%]
6/54 (11.1%)
[4.2%, 22.6%]
Moderate or Severe PV Leak
4/162 (2.5%)
[0.7%, 6.2%]
1/53 (1.9%)
[0.0%, 10.1%]
1
Composite of all-cause mortality, all stroke, moderate or severe obstruction, moderate or severe paravalvular leak. Mortality and
stroke are calculated at 30 days. The moderate or severe obstruction and paravalvular leak use the Echo core lab’s determination at
the 30-day follow-up visit.
2
Doppler velocity index (DVI) < 0.25 per the echo core lab read.
3
Confidence intervals calculated using exact binomial calculations. The confidence intervals are calculated without multiplicity
adjustment. The adjusted confidence intervals could be wider than presented here. As such, confidence intervals are provided to
illustrate the variability only and should not be used to draw any statistical conclusion.