Although the number of patients affected by heart failure has increased over the past 2 decades, the number of heart transplants has remained relatively constant at about 3,500–4,000 per year because of the shortage of donor organs. This shortage has increased the use of mechanical circulatory support devices for patients with advanced heart failure refractory to treatment, particularly, left ventricular assist devices (LVADs).1 The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) reports 5,408 such devices implanted between January 2012 and the end of the first quarter of 2014. Of these, 42.9% were considered destination therapy for patients not listed for heart transplant.2
As more devices have been implanted, LVAD infections, which are associated with substantial morbidity and mortality, have become an increasingly important problem. The definitive treatment, removing the device, is often not feasible, thus making LVAD infections a devastating complication for affected patients. One prospective study showed a 22% overall infection rate of LVADs and a 1 year mortality 5.6 times greater in patients with infections.3 Besides mortality, LVAD infections are associated with increased risk of pump thrombosis, bleeding complications, longer hospital stay, need for LVAD exchange, and failure to transplant.4 As more patients have LVAD support for longer periods, developing effective prevention and treatment strategies will become even more crucial.
The International Society for Heart and Lung Transplantation (ISHLT) defines an LVAD infection as an infection occurring in the presence of an LVAD that may or may not be attributable to the LVAD but that may warrant special consideration if an LVAD is in place. This definition includes several types of infections besides those directly associated with the device, such as catheter-related bloodstream infection or bacteremia attributable to pneumonia or urinary tract infection. LVAD infections can be further classified as follows: driveline related with accompanying soft tissue, pump pocket, LVAD-associated bloodstream infection, and endocardial infection with direct evidence of vegetation or infection on the internal surface of the pump.5
Earlier systematic reviews of LVAD infections have examined prophylactic strategies,5 , 6 tools for diagnosis and management,5 risk factors, and the microbiology of infections. The purpose of this systematic review is to analyze published studies regarding the incidence and risk factors for LVAD infections and describe the impact of each on patient-level outcomes.
Inclusion and Exclusion Criteria
Our protocol was registered with PROSPERO (registration number: CRD2014014114). We identified studies that described either the microbiology of continuous-flow LVAD infections or outcomes of these infections (mortality, length of stay, or costs of care). We included the following epidemiologic and experimental study designs: controlled trials, quasi-experimental designs, before-and-after studies, prospective and retrospective studies, and cross-sectional studies. We excluded individual case reports; review articles; basic science papers; animal studies; case–control studies (as our outcomes of interest are epidemiologic); studies primarily describing outcomes of right ventricular assist devices, biventricular assist devices, pneumatic LVADs (as infection rates were significantly higher in these first-generation devices); and pneumatic total artificial hearts. For mixed-population studies, authors were contacted to determine whether a subset of data for patients who received continuous-flow devices could be obtained. Finally, pediatric studies were also excluded, as the indications and use of LVADs in adult and pediatric populations are distinct.
When a study was reported as both a preliminary and final analysis, preliminary analyses were excluded. For studies in which there was substantial, secondary data analysis reported separately for new outcomes, the results were combined for reporting purposes to minimize duplication.
Outcomes of Interest
Infections were the primary outcomes of interest in this study. We abstracted data regarding type of infection; microorganisms isolated; attempted therapies; patient-level outcomes of relapse or reinfection, or both; treatment failures; length of stay; and mortality. Infections were defined from individual studies; these definitions were abstracted and compared.
With the assistance of a professional medical librarian at our institution, we determined our strategy for the literature search. We did not apply any language restrictions and searched the electronic databases of Medline (PubMed), Web of Science, EMBASE, Ovid, and CINAHL. We attempted to ensure a complete search of the health-related gray literature through searches of pertinent conference proceedings and abstracts. We manually reviewed the included references for other potentially relevant records.
Study Quality Assessment
Studies were assessed for methodologic quality by using the risk-of-bias assessment tool described in the Cochrane Handbook for Systematic Reviews. 7 This tool allows for subjective assessment of bias across six domains, including selection, performance, attrition, detection, and reporting. The data were summarized using Review Manager 5 software (Cochrane Collaboration, Nordic Cochrane Center, Copenhagen, Denmark).
Data were abstracted using a standard REDCap form (Research Electronic Data Capture, Vanderbilt University; see Supplemental Digital Content 1, http://links.lww.com/ASAIO/A188) by two independent reviewers. Disagreements were resolved by discussion. Data were synthesized qualitatively by category and, when sufficient data were available, quantitatively using the DerSimonian and Laird random-effects method for meta-analysis and Cochrane Review Manager 5 software.
Ninety distinct studies were included in our final synthesis (Figure 1). Study characteristics, patient comorbidities, and infection data are summarized in Tables 1–3 (Supplemental Digital Content, http://links.lww.com/ASAIO/A206).
Definitions for LVAD infection were not consistent among the various registries, including in INTERMACS (10 studies), J-MACS (three studies), and ISHLT (nine studies). One study used the Centers for Disease Control/National Healthcare Network Surveillance definitions for reporting on bloodstream infection. Two studies used their own definitions for percutaneous site infection. The remaining studies did not include precise definitions for LVAD infections.
Devices and Procedure Characteristics
The most extensively studied device was the HeartMate II, with 32 studies reporting on it exclusively. Thirteen studies described the HeartWare HVAD alone. A mix of HVAD and HeartMate II data was reported in 21 studies. Other combinations of VentrAssist, HeartMate II, Evaheart, DuraHeart, and the Micromed DeBakey were reported in 11 studies. Two reported exclusively on the DuraHeart. Three studies reported results of Jarvik 2000 implantations. One study reported on the Evaheart alone. The remaining 13 studies specified continuous-flow devices but did not specify the type of device.
Three studies directly compared infection rates between the HeartMate II and the HeartWare HVAD. In the first study, overall infections were significantly higher (p = 0.02), as were percutaneous infections (p = 0.01) associated with the HeartMate II.8 The second study found the opposite, that is, a higher rate of infection for the HVAD than the HeartMate II.9 In another study that compared the HeartMate II to the Evaheart LVAD, the HeartMate II was associated with lower infection rates.10 These results are shown in the forest plot in Figure 2. However, the heterogeneity and small numbers of patients in these studies limited the conclusions that could be drawn from the pooled estimate. Several strategies for prophylaxis and wound dressing were discussed (see Supplemental Digital Content 2, http://links.lww.com/ASAIO/A189), but none were clearly superior.
Fifty-two studies showed driveline infections to be the most common infection associated with LVADs, and it was the only infection described in several studies. Two studies found that the prognosis for a driveline infection was not particularly poor, and these infections were not associated with pump thrombosis or stroke.11 , 12 Another study found that driveline infections tended to occur late, at a median of 190 days postoperatively.13 In general, these infections were managed successfully with a combination of local debridement and antimicrobial therapy; LVAD removal was not necessary in most cases.
Infection of the pump pocket was the predominant infection reported in a series of patients treated with antibiotic beads plus debridement.14 Pump pocket infection was nearly as common as driveline infection in one study15 and was usually the second most common infection in studies reporting both pump pocket infection and driveline infection.15–18 The prognosis for patients with pump pocket infection was not studied specifically in any of the included reports.
Although less frequently reported overall, bloodstream infections were reported in one study to be the most common infectious complication of LVAD implantation.19 In addition, Aggarwal et al.20 found bloodstream infections to be associated with increased risk of both hemorrhagic and ischemic stroke; however, transient bacteremia, which was not defined, was excluded. Aldeiri et al.21 also reported an association between bloodstream infection, specifically Pseudomonas bacteremia, and stroke. The risk of increased mortality, stroke, and Pseudomonas bacteremia was also reported by Trachtenberg et al.22
Sources of bacteremia were not clear. Forest et al.23 reported that 43% of patients had secondary bacteremia from driveline infections. They also noted that patients with bloodstream infections were hospitalized longer than patients with driveline infections. Fungemia was not studied. Bloodstream infections were the predominant infection reported in a study by Schulman et al.24 comparing pulsatile and axial flow devices. However, they did not speculate on a reason for this finding. Starling et al.25 also reported a similar predominance of bloodstream infection in their LVAD patients. One study reported 10 cases of asymptomatic bacteremia, which were most often Gram positive (90%) but had no other clearly unifying characteristics.26
Infection Outcomes and Treatment
Studies reporting an association between infection and mortality are summarized in Figure 3. Infection incidence and mortality associated with LVAD infections appeared to decrease over time, as noted in a registry study that compared rates of complications in those who received a HeartMate II before and after the device’s approval by the US Food and Drug Administration. This trend appeared to be associated with a Center’s increased experience in implanting and subsequently managing the devices, as well as with the use of smaller devices with better flow dynamics.
Chamogeorgakis et al.27 noted that the most important risk factor for infection reported was a continued need for LVAD support. These authors recommended careful evaluation of the patient to ensure that support was still necessary before considering explantation followed by reimplantation.
The effect of infection on long-term patient outcomes was described in 11 studies with varying results, and two studies noted no impact of infection on long-term outcomes.28 , 29 Another noted a high rate of infection-associated deaths in a cohort of patients who were substance abusers. One registry study showed LVAD infections to be significantly associated with poor survival after adjusting for age and comorbidities, with 19% of patients experiencing an LVAD infection during their first year of support.30 However, two other studies did not find infection to be associated with increased mortality, although they did show increased hospital length of stay in patients with infection.23 , 31 LVAD infections were reported as a leading cause for readmission in five studies.17 , 32–35
The necessity of pump exchange is not clear. One study noted a particularly poor prognosis with candidemia and concomitant implantation of a cardiac implanted electronic device (CIED), and failure to remove the device during pump exchange was associated with poor outcomes.36 Another investigation noted good outcomes with pump exchange for treatment of driveline infections and pump pocket infections, with no mortality and low recurrence rates.37
One study reported a salvage protocol where, when infection was suspected, the driveline and pocket were debrided and antibiotic beads placed, followed by subsequent debridement of all infected tissues and replacement of the LVAD.14 When the culture no longer showed infection, the surgeons proceeded to definitive closure of the incision and possible flap coverage. This protocol was successful in clearing infection in 65% of patients. However, lower success rates were noted for Pseudomonas species compared with infections caused by Staphylococcus aureus, Candida species, and other Gram-negative organisms, which were more likely to resolve.14 Causative microorganisms are discussed in Supplemental Digital Content 3 (http://links.lww.com/ASAIO/A190). Other demographic risk factors examined are discussed in Supplemental Digital Content 4 (http://links.lww.com/ASAIO/A191).
Assessments of study quality are summarized in Table 4 (Supplemental Digital Content, http://links.lww.com/ASAIO/A207). In general, we found a low risk for selection, performance, and detection bias. Reporting bias was more common. Attrition bias was rated as low or unclear in most studies.
Despite substantial heterogeneity across studies, we can draw a few conclusions from the data. First, driveline infections are the most common type of LVAD infection described in the literature. This finding is consistent with what is reported in the INTERMACS database, where driveline infections in continuous-flow LVADs are reported to occur at 1.31 per 100 patient months early (first 3 months post-implantation) and 1.42 per 100 patient months late. The most common types of infections are early pulmonary infections (4.58 per 100 patient months) and early urinary tract infections (3.36 per 100 patient months), neither of which are strictly device-related.38
Second, bloodstream infection is a serious complication of LVAD implantation. Two studies found an association between stroke and bloodstream infection.20 , 21 Managing bloodstream infections in LVAD recipients are controversial. Most treating physicians opt for chronic, suppressive antibiotic therapy when the LVAD is clearly the source of infection; however, the best approach for managing a severe bloodstream infection from secondary sources in LVAD recipients is unclear. There is also no data to guide selection of agents for chronic suppression.
Third, and perhaps most important, we have identified a number of knowledge gaps that need to be addressed in future research. Most patients were white men; therefore, more research is needed to determine the incidence and outcomes of infections in women and minorities. The only study to specifically describe sex differences reported that women had fewer infections, but the reasons were not known.39 Preventive strategies were also not well defined. A chlorhexidine disc and sutureless fixation device appeared promising in one study, but the patient cohort was too small to generalize the conclusions.40 Likewise, the degree of detail in the study about silver dressings41 make it difficult to form a strong conclusion about the true benefit of this preventive strategy. Finally, demographic risk factors are poorly understood. Hyperbilirubinemia (>6 mg/dL) was associated with 100% mortality in one study (103). The variable immunologic effects related to foreign material in the devices also complicates understanding of these effects on LVAD patients. One study, for example, found that procalcitonin values were of limited use because of the systemic inflammatory response syndrome (SIRS) type most patients have after initial LVAD implantation.42
Drawing conclusions was difficult because existing data reporting standards and criteria used for defining LVAD infections are somewhat disparate. INTERMACS tracks major infections, defined as fever, drainage, or leukocytosis treated with nonprophylactic antimicrobial agents. Infections are classified into four general categories: localized nondevice infection, percutaneous/pocket infection, internal pump-component infection, and sepsis. The ISHLT provides the second, most commonly used set of definitions, where infections are generally classified as ventricular assist device (VAD)-specific, VAD-related, and non-VAD infections; and they further categorize infection by the area affected. However, this classification scheme does not differentiate between a bloodstream infection where a VAD is the definite source of bacteremia (LVAD-related bloodstream infection) and cases where the source of bloodstream infection in LVAD recipients is unclear (LVAD-associated bloodstream infection). More precise definitions are needed to accurately classify these complex infection syndromes.
The strategy for treating infection varied among the studies. We did not include one study in the review because it did not specify whether pulsatile devices were used. In that study, however, transvenous lead extraction was associated with improved survival to transplant for those with bloodstream infection related to CIED infections or lead endocarditis.43 Levy et al.44 reported that pump exchange was effective in eliminating persistent driveline infection. In this case series, antimicrobial beads were not efficacious. In general, data suggested that driveline infections can be managed in most patients with local debridement of the exit site combined with a defined course of pathogen-directed antimicrobial therapy. Device or pocket infections are typically managed with chronic, suppressive antimicrobial therapy. Emerging strategies may make more conservative local debridement with the use of negative-pressure wound dressing or other such interventions viable options in the near future. However, an LVAD exchange may be necessary if infection cannot be controlled, if relapses occur while the patient is taking suppressive antibiotic therapy, or if oral suppressive therapy is not feasible (e.g., a resistant organism). There are not enough published data to make recommendations for managing bloodstream infections in patients with LVADs.
Two important factors impacted study quality: the lack of uniform criteria to define LVAD infections and the reuse of existing data in the published literature, leading to substantial duplication of results. Study duplication is acknowledged by most investigators. In this extensive, secondary data analysis of the literature for LVAD infections, most of the published data on epidemiology and management are drawn from a relatively small number of patients. By contacting the authors and combining studies whenever duplication could be identified, we attempted to limit this effect. However, especially for the registry studies, this is a major limitation in this meta-analysis.
LVAD infections are a significant cause of morbidity and mortality in LVAD recipients. Most published data describe driveline infections. Bloodstream infections have not been well studied and may be linked to poorer outcomes. Current evidence is inadequate to rationally guide prevention, treatment, and chronic suppression of infections. With the approval of more continuous-flow pumps, the numbers of patients with implanted LVADs will certainly increase, as will LVAD-related and LVAD-associated infections. How to manage infectious complications definitely needs further study. Collaborative initiatives and registries that track infections and treatments may yield insights into how to address this growing problem.
We would like to thank Drs. Andrea Baronnetto, Laura Chan Lihua, Finn Gustaffson, Teruhiko Imamura, Kory Lavine, and Athanasios Tsiouris for providing unpublished data for this review.
1. Toyoda Y, Guy TS, Kashem APresent status and future perspectives of heart transplantation. Circ J 2013.77: 1097–1110,
2. Kirklin JK, Naftel DC, Pagani FD, et alSixth INTERMACS annual report: A 10,000-patient database. J Heart Lung Transplant 2014.33: 555–564,
3. Gordon RJ, Weinberg AD, Pagani FD, et alProspective, multicenter study of ventricular assist device infections. Circulation 2013.127: 691–702,
4. Kilic AThe future of left ventricular assist devices. J Thorac Dis 2015.7: 2188–2193,
5. Nienaber J, Wilhelm MP, Sohail MRCurrent concepts in the diagnosis and management of left ventricular assist device infections. Expert Rev Anti Infect Ther 11: 201–210.
6. Acharya MN, Som R, Tsui SWhat is the optimum antibiotic prophylaxis in patients undergoing implantation of a left ventricular assist device? Interact Cardiovasc Thorac Surg 2012.14: 209–214,
7. Higgins JPT, Green SCochrane Collaboration. Cochrane Handbook for Systematic Reviews of Interventions. 2008.Chichester, England; Hoboken, NJ, Wiley-Blackwell,
8. Sabashnikov A, Mohite PN, Weymann A, et alOutcomes after implantation of 139 full-support continuous-flow left ventricular assist devices as a bridge to transplantation. Eur J Cardiothorac Surg 2014.46: e59–e66,
9. Majure DT, Sheikh FH, Hofmeyer M, et alComparison of hospitalization rates with the HeartWare HVAD and HeartMate II left ventricular assist devices. J Heart Lung Transplant 2015.34: S198,
10. Matsumoto Y, Fujita T, Hata H, et alHemodynamic performance and early clinical result, EVAHEART and HeartMate II. J Heart Lung Transplant 2015.34: S227,
11. Fried J, Cagliostro B, Levin A, et alDriveline infection
is not associated with increased risk of thrombotic events in CF-LVAD patients. J Heart Lung Transplant 2015.34: S27–S28,
12. Van Meeteren J, Maltais S, Dunlay S, et alPercutaneous driveline infection
does not increase subsequent risk of stroke and pump thrombus during support with a left ventricular assist device. J Heart Lung Transplant 2015.34: S66,
13. Imamura T, Kinugawa K, Nitta D, et alReadmission due to driveline infection
can be predicted by new score by using serum albumin and body mass index during long-term left ventricular assist device support. J Artif Organs 2015.18: 120–127,
14. Kretlow JD, Brown RH, Wolfswinkel EM, et alSalvage of infected left ventricular assist device with antibiotic beads. Plast Reconstr Surg 2014.133: 28e–38e,
15. Schaffer JM, Allen JG, Weiss ES, et alInfectious complications after pulsatile-flow and continuous-flow left ventricular assist device implantation. J Heart Lung Transplant 2011.30: 164–174,
16. Struber M, Sander K, Lahpor J, et alHeartMate II left ventricular assist device; early European experience. Eur J Cardiothorac Surg 2008.34: 289–294,
17. Smedira NG, Hoercher KJ, Lima B, et alUnplanned hospital readmissions after HeartMate II implantation: Frequency, risk factors, and impact on resource use and survival. JACC Heart Fail 2013.1: 31–39,
18. Nishinaka T, Ichihara Y, Komagamine M, et alJapanese experience of long-term mechanical circulatory support with EVAHEART LVAD. J Heart Lung Transplant 2015.34: S153,
19. Yost G, Pappas P, Tatooles A, Bhat GDoes delayed sternal closure cause increased infection
rates after left ventricular assist device implantation? J Heart Lung Transplant 2015.34: S68,
20. Aggarwal A, Gupta A, Kumar S, et alAre blood stream infections associated with an increased risk of hemorrhagic stroke in patients with a left ventricular assist device? ASAIO J 2012.58: 509–513,
21. Aldeiri M, Alvarez P, Cordero-Reyes AM, et alPseudomonas aeruginosa bacteremia in patients supported with a left ventricular assist device is associated with an increased risk of hemorrhagic stroke. J Card Fail 2013.1: S77,
22. Trachtenberg BH, Aldeiri M, Cordero-Reyes AM, et alPersistent blood stream infections are associated with cerebrovascular accidents in patients with continuous flow lvads. J Heart Lung Transplant2014.1: S21–S22,
23. Forest SJ, Friedmann P, Goldstein DJBacteremia after implantation of continuous flow devices: Associated factors and long-term outcomes. J Heart Lung Transplant 2013.1: S280,
24. Schulman AR, Martens TP, Christos PJ, et alComparisons of infection
complications between continuous flow and pulsatile flow left ventricular assist devices. J Thorac Cardiovasc Surg 2007.133: 841–842,
25. Starling RC, Naka Y, Boyle AJ, et alResults of the post-U.S. Food and Drug Administration-approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation: A prospective study using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). J Am Coll Cardiol 2011.57: 1890–1898,
26. Tons MZ, Kalavrouzioutis D, Nagpal DA, et alLate onset infection
in patients with ventricular assist devices: Etiology, management and outcomes. J Heart Lung Transplant 2013.1: S187,
27. Chamogeorgakis T, Koval CE, Smedira NG, Starling RC, Gonzalez-Stawinski GVOutcomes associated with surgical management of infections related to the HeartMate II left ventricular assist device: Implications for destination therapy patients. J Heart Lung Transplant 2012.31: 904–906,
28. Choudhary N, Chen L, Sherazi S, et alIncidence, microbiologic profile and outcomes of device related infections in advanced heart failure patients treated with left ventricular assist device. J Card Fail 2013.1: S20,
29. Fleissner F, Avsar M, Malehsa D, et alReduction of driveline infections through doubled driveline tunneling of Left Ventricular Assist Devices (LVAD). J Artif Organs 2012.36: A23,
30. Goldstein DJ, Naftel D, Holman W, et alContinuous-flow devices and percutaneous site infections: Clinical outcomes. J Heart Lung Transplant2012.31: 1151–1157,
31. Donahey E, Polly D, Vega D, et alMultidrug resistant organism infections in patients with left ventricular assist devices. Criti Care Med2012.1: 82–83,
32. Topkara VK, Kondareddy S, Malik F, et alInfectious complications in patients with left ventricular assist device: Etiology and outcomes in the continuous-flow era. Ann Thorac Surg 2010.90: 1270–127,
33. Kimura M, Kinoshita O, Nawata K, et alMidterm outcome of implantable left ventricular assist devices as a bridge to transplantation: Single-center experience in Japan. J Cardiol 2015.65: 383–389,
34. Akhter SA, Badami A, Murray M, et alHospital readmissions after continuous-flow left ventricular assist device implantation: Incidence, causes, and cost analysis. Ann Thorac Surg2015.100: 884–889,
35. Hasin T, Marmor Y, Kremers W, et alReadmissions after implantation of axial flow left ventricular assist device. J Am Coll Cardiol 2013.61: 153–163,
36. Nienaber JJ, Kusne S, Riaz T, et alClinical manifestations and management of left ventricular assist device-associated infections. Clin Infect Dis 2013.57: 1438–1448,
37. Masood MF, Romano M, Haft JW, Hasan R, Aaronson K, Pagani FEffectiveness of continuous flow left ventricular assist device exchange for recurrence of major drive line and pump pocket infection
. J Heart Lung Transplant 2014.1: S196–S197,
38. INTERMACS: Interagency Registry for Mechanically Assisted Circulatory Support: Quarterly Statistical Report 2015 Q1: Implant and Event Dates: June 23,2006 to March 31 2015, 2015.Birmingham, INTERMACS,
39. Bogaev RC, Pamboukian SV, Moore SA, et alHeartMate II Clinical Investigators: Comparison of outcomes in women versus men using a continuous-flow left ventricular assist device as a bridge to transplantation. J Heart Lung Transplant 2011.30: 515–522,
40. Baronetto A, Centofanti P, Attisani M, et alA simple device to secure ventricular assist device driveline and prevent exit-site infection
. Interact Cardiovasc Thorac Surg 2014.18: 415–417,
41. Cagliostro B, Levin AP, Parkis G, et alReduction of drive line infection
in continuous flow assist devices: Use of standard kit including silver dressing and anchoring device. J Heart Lung Transplant 2014.1: S102,
42. Holek M, Kettner J, Franekova J, Jabor AProcalcitonin levels in patients undergoing left ventricular assist device implantation. Crit Care 2015.19 (suppl 1): P61,
43. Gosev I, Maytin M, Ejiofor JI, et alDoes transvenous lead extraction improve outcomes for ventricular assist device patients? J Heart Lung Transplant 34: S223.
44. Levy DT, Guo Y, Simkins J, et alLeft ventricular assist device exchange for persistent infection
: A case series and review of the literature. Transpl Infect Dis 2014.16: 453–460,
45. Haglund NA, Davis ME, Tricarico NM, Keebler ME, Maltais SReadmissions after continuous flow left ventricular assist device implantation: Differences observed between two contemporary device types. ASAIO J 2015.61: 410–416,
46. Miller LW, Pagani FD, Russell SD, et alHeartMate II Clinical Investigators: Use of a continuous-flow device in patients awaiting heart transplantation. N Engl J Med 2007.357: 885–896,
47. Morshuis M, El-Banayosy A, Arusoglu L, et alEuropean experience of DuraHeart magnetically levitated centrifugal left ventricular assist system. Eur J Cardiothorac Surg 2009.35: 1020–1027; discussion 1027,
48. Lahpor J, Khaghani A, Hetzer R, et alEuropean results with a continuous-flow ventricular assist device for advanced heart-failure patients. Eur J Cardiothorac Surg 2010.37: 357–361,
49. Wieselthaler GM, O’Driscoll G, Jansz P, Khaghani A, Strueber MInitial clinical experience with a novel left ventricular assist device with a magnetically levitated rotor in a multi-institutional trial. J Heart Lung Transplant 2010.29: 1218–1225,
50. Garbade J, Barten M, Bittner H, et alOutcomes for continuous-flow left ventricular assist device patients stratified by severity of clinical status. Int J Artif Organs 2011.34: 682,
51. John R, Naka Y, Smedira NG, et alContinuous flow left ventricular assist device outcomes in commercial use compared with the prior clinical trial. Ann Thorac Surg 2011.92: 1406–1413; discussion 1413,
52. Brewer RJ, Lanfear DE, Sai-Sudhakar CB, et alExtremes of body mass index do not impact mid-term survival after continuous-flow left ventricular assist device implantation. J Heart Lung Transplant 2012.31: 167–172,
53. Bomholt T, Moser C, Sander K, et alDriveline infections in patients supported with a HeartMate II: Incidence, aetiology and outcome. Scand Cardiovasc J 2011.45: 273–278,
54. Eleuteri KL, El-Banayosy A, Suzanne WDriveline staging system: Help in managing acute and chronic driveline infections. J Heart Lung Transplant2012.1: S86,
55. Guerrero-Miranda C, Baran DA, Emmanuel O, et alClassification of ventricular assist device infections according to ISHLT formulation and device generation. J Heart Lung Transplant 2012.1: S21,
56. Hozayen SM, Soliman AM, Eckman PMComparison of two ventricular assist device dressing change protocols. J Heart Lung Transplant 2012.31: 108–109,
57. Kamdar F, Eckman P, Goldstein D, et alPump-related infections (PRI) after implantation of continuous-flow left ventricular devices (CF LVADS): Analysis of 2900 patients from the interagency registry for mechanically assisted circulatory support (INTERMACS). J Heart Lung Transplant 2012.1: S19–S20,
58. Krabatsch T, Schweiger M, Vierecke J, et alAdverse events and complications profile after HVAD LVAD implantations in adult patients. J Heart Lung Transplant 2012.1: S134,
59. Maiani M, Tarzia V, Di Giammarco G, et alPreoperative intermacs scale and outcomes of “all-comers” undergoing LVAD implantation: Results from the Jarvik 2000 Italian registry. Transplantation 2012.94: 293,
60. Mano A, Teuteberg JJ, Bermudez CA, et alThe relation of body size and outcome in patients using continuous flow left ventricular assist devices. J Heart Lung Transplant 2012.1: S258–S259,
61. Menon AK, Hausshofer M, Autschbach R, Spillner JWLow infection
rate after implantation of the HeartMate II LVAD. J Thorac Cardiovasc Surg 2012.60: PP109,
62. Park SJ, Milano CA, Tatooles AJ, et alHeartMate II Clinical Investigators: Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circ Heart Fail 2012.5: 241–248,
63. Popov AF, Hosseini MT, Zych B, et alClinical experience with HeartWare left ventricular assist device in patients with end-stage heart failure. Ann Thorac Surg 2012.93: 810–815,
64. Schibilsky D, Benk C, Haller C, et alDouble tunnel technique for the LVAD driveline: Improved management regarding driveline infections. J Artif Organs 2012.15: 44–48,
65. Tarzia V, Livi U, Di Giammarco G, et alLow infection
rates in Jarvik 2000 LVAD. Are post-auricular cable and pump configuration playing a positive effect? J Heart Lung Transplant 2012.1: S175,
66. Haj-Yahia S, Birks EJ, Rogers P, et alMidterm experience with the Jarvik 2000 axial flow left ventricular assist device. J Thorac Cardiovasc Surg 2007.134: 199–203,
67. Lalonde SD, Alba AC, Rigobon A, et alClinical differences between continuous flow ventricular assist devices: A comparison between HeartMate II and HeartWare HVAD. J Card Surg 2013.28: 604–610,
68. Slaughter MS, Pagani FD, McGee EC, et alHeartWare ventricular assist system for bridge to transplant: Combined results of the bridge to transplant and continued access protocol trial. J Heart Lung Transplant 2013.32: 675–683,
69. Stulak JM, Maltais S, Cowger J, et alPrevention of percutaneous driveline infection
after left ventricular assist device implantation: Prophylactic antibiotics are not necessary. ASAIO J 2013.59: 570–574,
70. Wu L, Weng YG, Dong NG, et alOutcomes of HeartWare Ventricular Assist System support in 141 patients: A single-centre experience. Eur J Cardiothorac Surg 201344: 139–145,
71. Chan LL, Tan TE, Tan BH, et alLeft ventricular assist device (LVAD) driveline infections in a South East Asian single centre experience. Glob Heart 2014.1: e172,
72. Cogswell R, Smith E, Hamel A, et alSubstance abuse at the time of left ventricular assist device implantation is associated with increased mortality. J Heart Lung Transplant 2014.33: 1048–1055,
73. Dean D, Ewald GA, Tatooles A, et alReduction in driveline infection
rates: Results from the heartmate II multicenter silicone-skin-interface (SSI) registry. J Heart Lung Transplant 2014.1: S11–S12,
74. Hieda M, Sata M, Seguchi O, et alImportance of early appropriate intervention including antibiotics and wound care for device-related infection
in patients with left ventricular assist device. Transplant Proc 2014.46: 907–910,
75. Jennings DL, Chopra A, Chambers R, Morgan JAClinical outcomes associated with chronic antimicrobial suppression therapy in patients with continuous-flow left ventricular assist devices. Artif Organs 2014.38: 875–879,
76. John R, Aaronson KD, Pae WE, et alHeartWare Bridge to Transplant ADVANCE Trial Investigators: Drive-line infections and sepsis in patients receiving the HVAD system as a left ventricular assist device. J Heart Lung Transplant 2014.33: 1066–1073,
77. Jorde UP, Kushwaha SS, Tatooles AJ, et alHeartMate II Clinical Investigators: Results of the destination therapy post-food and drug administration approval study with a continuous flow left ventricular assist device: A prospective study using the INTERMACS registry (Interagency Registry for Mechanically Assisted Circulatory Support). J Am Coll Cardiol 2014.63: 1751–1757,
78. Koval CE, Thuita L, Moazami N, Blackstone EEvolution and impact of drive-line infection
in a large cohort of continuous-flow ventricular assist device recipients. J Heart Lung Transplant 2014.33: 1164–1172,
79. Moazami N, Steffen RJ, Naka Y, et alLessons learned from the first fully magnetically levitated centrifugal LVAD trial in the United States: The duraheart trial. Ann Thorac Surg 2014.98: 541–547,
80. Nelson JA, Shaked O, Fischer JP, et alComplex wound management in ventricular assist device (VAD) patients: The role of aggressive debridement and vascularized soft tissue coverage. Ann Plast Surg 2014.73 (suppl 2): S165–70,
81. Nishi H, Toda K, Miyagawa S, et alInitial experience in Japan with HeartWare ventricular assist system. J Artif Organs 2014.17: 149–156,
82. Raymer DS, Vader JM, Nassif ME, et alIncreased BMI is associated with left ventricular assist device-related infectious complications. J Heart Lung Transplant 2014.1: S197,
83. Singh A, Russo MJ, Valeroso TB, et alModified HeartMate II driveline externalization technique significantly decreases incidence of infection
and improves long-term survival. ASAIO J 2014.60: 613–616,
84. Subbotina I, Hakmi S, Dobner S, et alHeartWare assist device-infections, bleedings, and thrombosis dominate morbidity and mortality. J Thorac Cardiovasc Surg 2014.62: SC106,
85. Takeda K, Takayama H, Kalesan B, et alLong-term outcome of patients on continuous-flow left ventricular assist device support. J Thorac Cardiovasc Surg 2014.148: 1606–1614,
86. Abou el ela A, Balsara KR, Lee A, et alDriveline infections in left ventricular assist devices: Review of management strategies and their outcomes. J Heart Lung Transplant 2015.34 (suppl 4): S214,
87. Birks EJ, McGee EC Jr, Aaronson KD, et alADVANCE Trial Investigators: An examination of survival by sex and race in the HeartWare Ventricular Assist Device for the Treatment of Advanced Heart Failure (ADVANCE) Bridge to Transplant (BTT) and continued access protocol trials. J Heart Lung Transplant 2015.34: 815–824,
88. Fudim M, Brown CL, Davis ME, et alDoes the utilization of a temporary external anchoring suture increase the risk of driveline infection
after implantation of a left ventricular assist device. J Heart Lung Transplant 34: S212–S213.
89. Haeck ML, Beeres SL, Höke U, et alLeft ventricular assist device for end-stage heart failure: Results of the first LVAD destination program in the Netherlands. Neth Heart J 2015.23: 102–108,
90. Harvey L, Holley C, Roy SS, et alStroke after left ventricular assist device implantation: Outcomes in the continuous-flow era. Ann Thorac Surg 2015.100: 535–541,
91. Henderson C, Patel K, Sayer G, et alExtremes of obesity and LVAD patient morbidity and mortality. J Heart Lung Transplant 34: S189.
92. Krishnamoorthy A, Pokorney SD, Lewis RK, et alCardiac implantable electronic device removal in patients with left ventricular assist device associated infections. J Cardiovasc Electrophysiol 2014.25: 1199–1205,
93. Lushaj EB, Badami A, Osaki S, et alImpact of age on outcomes following continuous-flow left ventricular assist device implantation. Interact Cardiovasc Thorac Surg 2015.20: 743–748,
94. Maltais S, Aaronson KD, Teuteberg JJ, et alTemporal differences in adverse event rates in patients bridged with the HeartWare left ventricular assist device. J Heart Lung Transplant 34: S44.
95. McCandless SP, Ledford ID, Mason NO, et alComparing velour versus silicone interfaces at the driveline exit site of HeartMate II devices: Infection
rates, histopathology, and ultrastructural aspects. Cardiovasc Pathol 2015.24: 71–75,
96. McMenamy M, Arabia F, Czer L, et alBreaking the myth of obesity as a contraindication to continuous flow left ventricular assist devices. J Heart Lung Transplant 34: S193.
97. Ono M, Sawa Y, Nakatani T, et alJapanese multicenter outcomes with the HeartMate II in the post-approval era: Focusing on results in patients with small body size. J Heart Lung Transplant 2015.34 (suppl 4): S205,
98. Potapov EV, Garbade J, Hakim-Meibodi K, et alThe HeartMate II pump in clinical practice - Results from 479 patients analyzed in a retrospective European multicenter study. J Heart Lung Transplant 34: S10.
99. Tsiouris A, Paone G, Nemeh HW, et alLessons learned from 150 continuous-flow left ventricular assist devices: A single institutional 7 year experience. ASAIO J 2015.61: 266–273,
100. Wus L, Manning M, Entwistle JW 3rdLeft ventricular assist device driveline infection
and the frequency of dressing change in hospitalized patients. Heart Lung 2015.44: 225–229,
101. Yoshioka D, Matsumiya G, Toda K, et alClinical results with Jarvik 2000 axial flow left ventricular assist device: Osaka University Experience. J Artif Organs 2014.17: 308–314,