Driveline infection has been a persistent problem with mechanical cardiac assist devices. The reported incidence of infection has been low in patients who receive a Jarvik 2000 continuous-flow left ventricular assist device when a skull-pedestal driveline exit site is used. We evaluated whether this is also true when a subcostal driveline exit site is used.

We reviewed baseline demographic variables, postimplantation vital signs, laboratory values, and culture results in patients who underwent Jarvik 2000 implantation at our center from April 2000 through October 2009, including follow-up through June 2014. All patients had a subcostal driveline exit site. We defined device-related infection as a positive blood or wound culture associated with a medical or surgical device intervention. Event and time-to-event rates were calculated.

Eighty-one patients received 89 Jarvik 2000 devices, all as bridges to transplantation. The median support duration was 69 days (interquartile range, 27–153 d; range, 2–2,249 d). Five superficial driveline infections and one incision-site infection occurred (0.002 events per patient-year of support). The median time from pump implantation to onset of driveline infection was 30 days; the incision-related infection occurred at 44 days.

The Jarvik 2000 has a low incidence of infection when implanted with use of a subcostal driveline exit site. The incidence of pump infections is particularly low. Using a subcostal driveline exit site may be as effective in preventing infections as using a skull-pedestal driveline exit site. We detail our findings in this report.

Heart disease is the world's leading overall cause of death.1  Patients with end-stage heart failure have a dismal prognosis even with optimal medical management.2  Continuous-flow left ventricular assist devices (LVADs) have provided a meaningful survival benefit to these patients.3  However, device-related complications remain substantial causes of morbidity and death and hinder wider LVAD use.4–9  Infections are among the most detrimental.10–12 

Typical infection sites are the driveline, pump body, pump pocket, and internal blood-contacting surfaces.12  Effective treatment may involve hospital readmission, antibiotic therapy, and surgical débridement. Severe infection may necessitate device removal, which can be catastrophic, particularly for patients who depend on LVADs as destination therapy.12  More LVADs are being implanted worldwide, so durable, uncomplicated support is crucial.3 

Unlike other LVADs, the continuous-flow Jarvik 2000® Ventricular Assist Device (Jarvik Heart, Inc.) has a pump inside the inlet cannula, and it is placed entirely within the left ventricular cavity (Fig. 1).13  This placement makes a pump pocket unnecessary and minimizes the need for extracardiac hardware, thus decreasing the risk of infectious complications. Furthermore, the Jarvik 2000 can be implanted not just through a median sternotomy, but also through a left anterolateral thoracotomy or left subcostal incision.14  These alternative incisions may prevent infections associated with sternal disruption.

Fig. 1

The Jarvik 2000 left ventricular assist device.

Image previously published in Myers TJ, et al. Development of the Jarvik 2000 intraventricular axial-flow left ventricular assist system. J Congest Heart Fail Circ Support 2000;1(3):133–40.13 

Fig. 1

The Jarvik 2000 left ventricular assist device.

Image previously published in Myers TJ, et al. Development of the Jarvik 2000 intraventricular axial-flow left ventricular assist system. J Congest Heart Fail Circ Support 2000;1(3):133–40.13 

Jarvik 2000 drivelines can be placed through a skull-pedestal or subcostal exit site. Infection rates associated with the former have been analyzed. We compared those findings with those in our cohort of Jarvik 2000 recipients, all of whom had a subcostal exit site.

Patients and Methods

Our Institutional Review Board approved this study. We retrospectively reviewed all Jarvik 2000 implantations at our institution from April 2000 (the first-ever clinical use of this device) through October 2009, with patient follow-up complete through June 2014. The patients were part of a bridge-to-transplant clinical trial.15  From that database, we collected baseline demographic variables, postimplantation vital signs, laboratory values, culture results, and data on medical or surgical interventions. Culture information was obtained from patients' charts. We defined device-related infection (the study's primary endpoint) as a positive blood or wound culture associated with a medical or surgical device intervention. Infections were categorized as superficial driveline, surgical site, or pump infections. We defined pathogens as bacterial or fungal and categorized them by species. We calculated event and time-to-event rates.

Results

During the study period, 81 patients received 89 Jarvik 2000 LVADs. Of these implantations, 75 were primary, 4 replaced a previous pulsatile LVAD, and 2 replaced a HeartMate II LVAD (Thoratec, an Abbott company). Eight patients later had their original Jarvik 2000 exchanged for a new one. The median age of the 61 men (75%) and 20 women (25%) at first Jarvik 2000 implantation was 55 years (interquartile range [IQR], 45–63 yr; range, 16–79 yr). The median duration of device support was 69 days (IQR, 27–153 d; range, 2–2,249 d); the cumulative duration was 36 patient-years.

Of the 81 patients, 5 had a total of 6 device-related infections: 5 affected the superficial driveline and one, the subcostal implantation incision site (Table I). Four of the driveline infections occurred in patients whose Jarvik 2000 was a primary implant, and one was in a patient whose device had replaced a HeartMate II. Two of the driveline infections were coagulase-negative Staphylococcus aureus, 2 were methicillin-resistant S. aureus, and one was vancomycin-resistant Enterococcus (Table II). The median time from implantation to driveline infection was 30 days (IQR, 30–94 d; range, 16–198 d). The incision-site infection was Penicillium; it occurred at 44 days. The event rate was 0.002 per patient-year of support.

Table I.

Characteristics of the Patients Who Had Device-Related Infections

Characteristics of the Patients Who Had Device-Related Infections
Characteristics of the Patients Who Had Device-Related Infections
Table II.

Device-Related Infections

Device-Related Infections
Device-Related Infections

Discussion

During the past decade, continuous-flow LVADs have become increasingly beneficial as therapy for end-stage heart failure. However, long-term support is hindered by device-related complications. Chief among these are infections, which substantially increase the morbidity and mortality rates associated with LVAD implantation. Because advanced heart disease is becoming more prevalent, donor hearts for transplantation are scarce; therefore, the use of mechanical circulatory support for destination therapy continues to expand, which makes minimizing device-related infections an important goal.

In our trial of 81 patients who received Jarvik 2000 support as bridge to transplant, the infection rate was 0.002 events per patient-year, compared with a rate of 0.48 for patients given a HeartMate II in a bridge-to-transplant trial,16  and 0.27 for patients given a HeartMate II in a destination-therapy trial.17  Although exact comparisons between the 3 trials cannot be made, the inclusion and exclusion criteria for all of them were similar, and the differences in event rates are notable. Siegenthaler and colleagues18  also reported a low incidence of device-related infections (0.24/300 d) in patients who underwent Jarvik 2000 implantation with a skull-pedestal driveline exit site. We tunneled all drivelines to a subcostal exit site and observed a low infection rate.

Advantages of the Jarvik 2000 over other continuous-flow LVADs may contribute to a lower infection rate. Because of its smaller, more flexible driveline, less surgical dissection is needed for placement. Perhaps even more important, its intracardiac location eliminates the need for a pump pocket—infections of which are typically caused by gram-positive Staphylococci, the most difficult LVAD-related infection to control.19  Finally, the intraventricular pump is surrounded by myocardium and blood, minimizing the need for extracardiac hardware and decreasing the risk of surgical contamination.

Our study has limitations. The single-center, retrospective data collection may have resulted in bias. In addition, this patient cohort represents an early Jarvik 2000 experience from a bridge-to-transplant trial, which may not generally apply to other Jarvik 2000 populations.

In conclusion, Jarvik 2000 implantation is associated with a low incidence of device-related infection in general. Moreover, the use of a subcostal driveline exit site, which is faster and less complicated to create than a skull-pedestal site, resulted in a very low rate of infection and may be appropriate for many patients.

References

References
1.
World Health Organization
.
Global status report on noncommunicable diseases 2010. Description of the global burden of NCDs, their risk factors and determinants
. .
2.
Rose
EA
,
Gelijns
AC
,
Moskowitz
AJ
,
Heitjan
DF
,
Stevenson
LW
,
Dembitsky
W
,
et al
.
Long-term use of a left ventricular assist device for end-stage heart failure
.
N Engl J Med
2001
;
345
(
20
):
1435
43
.
3.
Kirklin
JK
,
Naftel
DC
,
Pagani
FD
,
Kormos
RL
,
Stevenson
LW
,
Blume
ED
,
et al
.
Sixth INTERMACS annual report: a 10,000-patient database
.
J Heart Lung Transplant
2014
;
33
(
6
):
555
64
.
4.
Boyle
AJ
,
Jorde
UP
,
Sun
B
,
Park
SJ
,
Milano
CA
,
Frazier
OH
,
et al
.
Pre-operative risk factors of bleeding and stroke during left ventricular assist device support: an analysis of more than 900 HeartMate II outpatients
.
J Am Coll Cardiol
2014
;
63
(
9
):
880
8
.
5.
Cowger
JA
,
Romano
MA
,
Shah
P
,
Shah
N
,
Mehta
V
,
Haft
JW
,
et al
.
Hemolysis: a harbinger of adverse outcome after left ventricular assist device implant
.
J Heart Lung Transplant
2014
;
33
(
1
):
35
43
.
6.
Kalavrouziotis
D
,
Tong
MZ
,
Starling
RC
,
Massiello
A
,
Soltesz
E
,
Smedira
NG
,
et al
.
Percutaneous lead dysfunction in the HeartMate II left ventricular assist device
.
Ann Thorac Surg
2014
;
97
(
4
):
1373
8
.
7.
Toda
K
,
Sawa
Y.
Clinical management for complications related to implantable LVAD use
.
Gen Thorac Cardiovasc Surg
2015
;
63
(
1
):
1
7
.
8.
Topkara
VK
,
Kondareddy
S
,
Malik
F
,
Wang
IW
,
Mann
DL
,
Ewald
GA
,
Moazami
N.
Infectious complications in patients with left ventricular assist device: etiology and outcomes in the continuous-flow era
.
Ann Thorac Surg
2010
;
90
(
4
):
1270
7
.
9.
Zierer
A
,
Melby
SJ
,
Voeller
RK
,
Guthrie
TJ
,
Ewald
GA
,
Shelton
K
,
et al
.
Late-onset driveline infections: the Achilles' heel of prolonged left ventricular assist device support
.
Ann Thorac Surg
2007
;
84
(
2
):
515
20
.
10.
Goldstein
DJ
,
Naftel
D
,
Holman
W
,
Bellumkonda
L
,
Pamboukian
SV
,
Pagani
FD
,
Kirklin
J.
Continuous-flow devices and percutaneous site infections: clinical outcomes
.
J Heart Lung Transplant
2012
;
31
(
11
):
1151
7
.
11.
Koval
CE
,
Thuita
L
,
Moazami
N
,
Blackstone
E.
Evolution and impact of drive-line infection in a large cohort of continuous-flow ventricular assist device recipients
.
J Heart Lung Transplant
2014
;
33
(
11
):
1164
72
.
12.
Nienaber
JJ
,
Kusne
S
,
Riaz
T
,
Walker
RC
,
Baddour
LM
,
Wright
AJ
,
et al
.
Clinical manifestations and management of left ventricular assist device-associated infections
.
Clin Infect Dis
2013
;
57
(
10
):
1438
48
.
13.
Myers
TJ
,
Gregoric
I
,
Tamez
D
,
Jarvik
R
,
Frazier
O
,
Inman
RW
,
et al
.
Development of the Jarvik 2000 intraventricular axial-flow left ventricular assist system
.
J Congest Heart Fail Circ Support
2000
;
1
(
3
):
133
40
. .
14.
Zucchetta
F
,
Tarzia
V
,
Bottio
T
,
Gerosa
G.
The Jarvik-2000 ventricular assist device implantation: how we do it
.
Ann Cardiothorac Surg
2014
;
3
(
5
):
525
31
.
15.
Jarvik Heart, Inc
.
Clinical protocol for evaluation of the Jarvik 2000 heart assist system
. .
16.
Slaughter
MS
,
Rogers
JG
,
Milano
CA
,
Russell
SD
,
Conte
JV
,
Feldman
D
,
et al
.
Advanced heart failure treated with continuous-flow left ventricular assist device
.
N Engl J Med
2009
;
361
(
23
):
2241
51
.
17.
Park
SJ
,
Milano
CA
,
Tatooles
AJ
,
Rogers
JG
,
Adamson
RM
,
Steidley
DE
,
et al
.
Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy
.
Circ Heart Fail
2012
;
5
(
2
):
241
8
.
18.
Siegenthaler
MP
,
Martin
J
,
Pernice
K
,
Doenst
T
,
Sorg
S
,
Trummer
G
,
et al
.
The Jarvik 2000 is associated with less infections than the HeartMate left ventricular assist device
.
Eur J Cardiothorac Surg
2003
;
23
(
5
):
748
55
.
19.
Chinn
R
,
Dembitsky
W
,
Eaton
L
,
Chillcott
S
,
Stahovich
M
,
Rasmusson
B
,
Pagani
F.
Multicenter experience: prevention and management of left ventricular assist device infections
.
ASAIO J
2005
;
51
(
4
):
461
70
.

Author notes

From: Division of Cardiothoracic Transplantation and Circulatory Support, Michael E. DeBakey Department of Surgery (Drs. Anand, Cohn, Frazier, Ganapathy, Letsou, Loor, Ogburn, and Shah), Baylor College of Medicine; and Department of Cardiopulmonary Transplantation and Center for Cardiac Support (Drs. Anand, Cohn, Frazier, Ganapathy, Letsou, and Loor), Texas Heart Institute; Houston, Texas 77030

Dr. Letsou is a consultant for Terumo Medical Corporation; Maquet (part of Getinge AB); and CorInnova, Inc. Dr. Loor receives grant support from St. Jude Medical (an Abbott company) and Medtronic, Inc. for his involvement in HeartMate and HeartWare clinical trials. Dr. Frazier has received consulting fees from Thoratec (an Abbott Company) and from Jarvik Heart, Inc.; and lecture fees, travel support, and grant support from Thoratec and from HeartWare. He is a medical advisory board member for HeartWare. He holds patent US8226712, “Total Artificial Heart System for Auto-Regulating Flow and Pressure,” licensed to Newheart Medical Devices, LLC.