test 9 heartmate II

Question 1

Heartmate II

Answer 1

 Axial flow device (2nd generation VAD)
 Reduced size/ weight compared to XVE
 Developed in the early 1990s
 Collaboration between engineers at Nimbus, Inc and Univeristy of Pittsburg
 Initially developed thru NIH grant

Question 2

1998 Nimbus, Inc was acquired by

Answer 2

ThermoCardiosystems

Question 3

2001 ThermoCardiosystems was acquired by

Answer 3

Thoratec Corp

Question 4

In 2016 Thoratect was acquired by

Answer 4

St. Jude Medical

Question 5

Heartmate II technical portion

Answer 5

 Electric Motor
 Rotor spins within magnetic field on inlet and outlet of bearings
 Only moving part of pump
 Ruby bearings
 PBU for power and to charge batteries
 Same system monitor and PBU as HM XVE
 Flow is an ESTIMATE
 Relationship between pump motor RPM speed and time-varying electrical power consumption of pump motor
 Not accurate when flow is less than 3LPM

Question 6

Heartmate II implantation and issues

Answer 6

 Implant is below the L. Costal Margin under the rectus abdominus muscle
- 2 to 3 cm from LAD and above the apex
 Leave LV Apex to diaphragm to pump
 Issues:
 Thrombus formation
 See abnormal power increase unrelated to change in pump flow (harder to spin)
- power leads came out of both sides of the system controller making it difficult to put in pocket
- pointed straight up toward the mitral valve

Question 7

Randomized Evolution of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Trial

Answer 7

 Pushed forward the concept of permanent device therapy
         Versus medical therapy
 Multicenter trial
 NIH Sponsored
 Trail of the Heartmate XVE LVAD
 Pilot phase started in 1996

Question 8

REMATCH Trial Analysis reported in 2001

Answer 8

 Highly significant benefit at 1 and 2 years compared to medical therapy alone, for patients who had very advanced heart failure and were not suitable candidates for transplant.
 Provided evidence for FDA to approve the device for Destination Therapy in 2002
 Medicare approved device for permanent implantation in 2003
 Set the stage for multiple clinical trials of other devices as permanent therapy for heart failure.

Question 9

Heartmate II and Clinical Trials without adverse events

Answer 9

 Randomized 200 non-transplant candidate patients at 40 centers
 Randomized to HMII or XVE.
 Primary end point was 2 year survival
 Secondary endpoint was an Adverse Event
 Found 46% of 134 patients with HMII were still living 2 years later with no incidence of stroke, reoperation to replace or repair device.
 Compared to 11% of the 66 patients in the control (XVE) group.

Question 10

Heartmate II and Clinical Trials with adverse events

Answer 10

 Survival to 1 year was 68%, Survival to 2 years was 58%
 Level of Adverse Events (infection, sepsis, Right heart failure)
 Lower in HMII group than in XVE group
 No pump failures in HMII group
 Improved QOL and functional status
 Shorter hospital stays for HMII group.

Question 11

1/20/2010 the HMII was approved as

Answer 11

• Destination Therapy device

Question 12

Heartmate II according to Thoratec Registry
Longest duration:
age:
BSA:

Answer 12

 Longest duration: 8 years
 Age: 11-87 years old
 BSA: 1.14-3.16m2
 90% have either been transplanted, recovered or supported to 6 months.