BTT+CAP Slaughter Flashcards
(22 cards)
Survival?
180d = 91%
360d = 84%
N=?
Primary Outcome?
N=332. (140+192)
Success=Survival on orig. device, transplant or explant for recovery
Conclusion ?
HVAD as BTT demonstrates high 180d survival rate despite low transplant rate.
AE’s are similar or better than historical BTT trials, despite longer exposure times due to longer survival & lower transplant rates.
Follow up ?
At least 6 mos. to
Over 3 years
Analysis July 31, 2012
Driveline Infection
- 9% 56/332
0. 25 PPY
Bleeding
Req. Surgery 14.8% 49/332
0.19 PPY
GI Bleeding 12.7% 42/332
0.28 PPY
Stroke Overall
- 8% (2pts having both)
28. 6% of stroke events fatal
ICVA
- 5% 25/332
- 09 PPY
88% survived event
HCVA
- 8% 26/332
- 09 PPY
46% of HCVA’s fatal
Hemolysis
- 2% 4/332
0. 02 PPY
Thrombus
Device Exchange
4.2%
- 7%
- 2.1% proc. related
- 4.2% suspected thrombus
- 2.4% other
After March 15, 2011 Pump Exchange for Thrombus
0.063 PPY to 0.027 PPY
55% drop
After March 15, 2011 Strokes
ICVA w/ MRS>0
5.1% to 2.8% (45% drop)
0.089 PPY to 0.047 PPY
HCVA’s w/MRS >0
5.1% to 4.7% (8% drop)
0.082 PPY to 0.074 PPY
6MWT distance improvement
Distance tripled
Study duration
3 yrs. 4 mos
August 2008 - December 2011
Medical Therapy & Device Design Enhancements March 2011 - December 2011
Medical Therapy & Device Design Enhancements
New Coring Tool
Sintered Pump
ASA 325mg
INR 2.0 - 3.0
Stroke Rate compared to HMII BTT & CAP trials
HMII Miller (BTT)
ICVA 0.13 PPY vs 0.09 HVAD
HCVA 0.05 PPY vs 0.09 HVAD
HMII Pagani (CAP)
ICVA 0.09 PPY vs 0.09 HVAD
HCVA 0.05 PPY vs 0.09 HVAD
ReVolve EU Study Stroke in PPY?
0.08 PPY
ReVolve EU Study Stroke in PPY?
0.08 PPY
Freedom from pump thrombus
98% at 3 mos.
92% at 1 yr.
Freedom from exchange for thrombus
99% at 3 mos.
95% at 1 yr.
HVAD Exchange for suspected thrombus
0.05 PPY (4.2%)
HVAD exchange rate for suspected thrombus post Anticoagulation adjustment, coring tool & sintering?
0.03 PPY
A 55% drop in exchange rate for suspected thrombus
