1. When and How to Replace an LVAD
Nader Moazami, MD
Department of Thoracic and Cardiovascular Surgery and Biomedical Engineering, Cleveland Clinic

2. Disclosures
NONE

3. > 10,000 patients, 141 Hospitals
Between June 23, 2006 and December 31, 2013, 158 hospitals participated in INTERMACS and, of these, 141 hospitals actively contributed information on a total of 10,542 primary implant patients. Cumulative patient accrual and the number of participating hospitals over this period are displayed.
Kirklin et al J Heart Lung Transplant Jun;33(6):555-64

4. Indications For LVAD Exchange
Mechanical Pump Failure (rare if ever)
Lead Failure (10-20%)
“Other”: inflow cannula malposition; outflow graft kinking; “bend relief” disconnection (<10%)
Infection (10%)

5. Infectious Complications

6. Hazard of Driveline infections
Koval et al JHLT 2014 Nov;33(11):

7. LVAD infection and Transplantation
Tong et al Ann Thorac Surg (in press)

8. Indications For LVAD Exchange
Pump Thrombosis/Hemolysis
(50-60%)

9. Free of Thrombosis at 3 Mo.
100 ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● 80 ● % ● 60 40
2006
2008
2010
2012
HeartMate II Implant Date

10. CONFIRMED Pump Thrombosis at 3 Months after HeartMate II Implantation30 20 25 15 CC
Duke 20 10
BJH
Devices with Confirmed Pump Thrombosis (%) 15 5
Figure 1. Overall Occurrence of Confirmed Pump Thrombosis at 3 Months after HeartMate II Implantation. Dashed lines represent the 95% confidence interval. There was a steep increase in the occurrence of thrombosis starting in early The inset shows the changing occurrence of confirmed pump thrombosis according to study site (Cleveland Clinic [CC], Barnes–Jewish Hospital [BJH], and Duke University Medical Center [Duke]). 10
2004
2006
2008
2010
2012
2014 5
2004
2006
2008
2010
2012
2014
Implantation Year
Starling RC et al. N Engl J Med DOI: /NEJMoa

11. Pump Thrombosis and Hemolysis

12. Clinical Presentation Conformed Pump Thrombosis (n=36)
Parameters
Number of Patients (% of N)
Asymptomatic, no new symptoms
4 (11.1)
Heart failure, new onset or worsening
20 (55.6)
Renal dysfunction
Chronic renal dysfunction
Acute renal dysfunction
8 (22.2)
0 (0)
Hematuria (N=30)
27 (90%)
Thromboembolism
1 (2.8)
Unexplained change in clinical status
NYHA functional status
Class I
Class II
Class III
Class IV
2 (5.6)
12 (33.3)
17 (47.2)
5 (13.9)

13. Clinical Spectrum of HM2 Pump Thrombosis
The clinical spectrum of VAD thrombosis. Patients with VAD thrombosis may be completely asymptomatic. The condition may progress, leading to a variable presentation, ranging from shortness of breath, low cardiac output state, valvular insufficiency, arrhythmias and right ventricular failure. With or without medical therapy, these patients can progress to cardiogenic shock and death. Despite the wide spectrum of presentations highlighted, there is a consistent finding of elevated LDH as a marker of active hemolysis in all patients.
Edo et al JHLT 34, (2015)

14. Months before Confirmed Pump Thrombosis
Elevated Lactate Dehydrogenase (LDH) Levels within 3 Months after HeartMate II Implantation
2,500
2,000
BJH
1,500
LDH (IU\L)
1,000
Figure 3. Elevated Lactate Dehydrogenase (LDH) Levels within 3 Months after HeartMate II Implantation. The overall estimate of the percentage of patients with LDH levels of more than 1000 IU per liter within 3 months after the implantation of a HeartMate II is shown, without regard to diagnosis of confirmed or suspected pump thrombosis. The parametric estimate is shown (solid line) with the 95% confidence interval (dashed lines). The occurrence of elevated LDH levels increased steadily starting in 2011, which was similar to the pattern observed for pump thrombosis. The inset shows changes in occurrence according to study site.
Duke
500 CC -3 -2 -1
Months before Confirmed Pump Thrombosis
Starling RC et al. N Engl J Med DOI: /NEJMoa

15. Mortality According to Management Strategy after Confirmed Pump Thrombosis70 60
Neither transplantation nor replacement 50 40
Patients Who Died (%) 30
Figure 5. Mortality According to Management Strategy after Confirmed Pump Thrombosis. Squares indicate deaths after heart transplantation or pump replacement, and diamonds indicate deaths of patients who did not undergo heart transplantation or pump replacement, with the horizontal axis truncated at 6 months. For reference, triangles indicate deaths without confirmed pump thrombosis during HeartMate II support from the time of implantation (gray). Symbols represent nonparametric estimates, and I bars 95% confidence intervals. The dashed line represents patients for whom follow-up data were available and who remained alive.
Transplantation or replacement 20 10
HeartMate II support without thrombosis 1 2 3 4 5 6
Months
Starling RC et al. N Engl J Med DOI: /NEJMoa

16. HVAD BTT Trial (n=382) Najjar, et al JHLT 33,;23-34
Kaplan-Meier analysis shows time to any thrombus event and time to left ventricular assist device exchange for pump thrombus.
Najjar, et al JHLT 33,;23-34

17. HVAD DT Trial (ENDURANCE)

18. When to Change the Pump? Heartmate 2 LDH>2.5X monitor closely
Superimposing Hemoglobinuria or any symptoms PUMP EXCHANGE
HVAD
Pump power elevavation: 1 or 2 rounds of tPA
If no resolution PUMP EXCHANGE

19. Evaluation Prior To Pump Exchange
TEE
Contrast-enhanced CT Scan with 3-D reconstruction

20. 3-D CT Imaging
Mohamed I et al Radiographics Mar-Apr;35(2):327-56

21. 3-D CT Imaging
Mohamed I et al Radiographics Mar-Apr;35(2):327-56

22. Bend Relief Disconnect
Mohamed I et al Radiographics Mar-Apr;35(2):

28. Advantages of Non-Sternotomy Approach
Less time on CPB
Less Bleeding
Shorter Ventilation
Less RV Failure
Shorter LOS

32. De-Airing

33. HVAD Exchange Left Anterolateral Thoracotomy
Schmitto et al Artif Organs Vol 38;6, 2014
Sajjad et al EJCTS 43; , 2012
Schmitto et al.
J Thorac Cardiovasc Surg Feb;143(2):511-3.

34. Conclusion Increasing number of exchanges for pump thrombosis
With HM2 medical treatment likely futile and subcostal approach is preferred.
With HVAD initial trial tPA seems warranted if unsuccessful them exchange through left anterolateral thoracotomy