Driveline Exit Site Research Articles

(7) - Device-Related Infection Rates of Continuous-Flow Ventricular Assist Devices Using a Thoracic Driveline Exit Site

(7) - Device-Related Infection Rates of Continuous-Flow Ventricular Assist Devices Using a Thoracic Driveline Exit Site

Multidrug-Resistant Organism Infections in Patients with Left Ventricular Assist Devices.

Left ventricular assist devices improve survival prospects in patients with end-stage heart failure; however, infection complicates up to 59% of implantation cases. How many of these infections are caused by multidrug-resistant organisms is unknown. We sought to identify the incidence, risk factors, and outcomes of multidrug-resistant organism infection in patients who have left ventricular assist devices. We retrospectively evaluated the incidence of multidrug-resistant organisms and the independent risk factors associated with them in 57 patients who had permanent left ventricular assist devices implanted at our institution from May 2007 through October 2011. Outcomes included death, transplantation, device explantation, number of subsequent hospital admissions, and number of subsequent admissions related to infection. Infections were categorized in accordance with criteria from the Infectious Diseases Council of the International Society for Heart and Lung Transplantation. Multidrug-resistant organism infections developed in 18 of 57 patients (31.6%)-a high incidence. We found 3 independent risk factors: therapeutic goal (destination therapy vs bridging), P=0.01; body mass index, P=0.04; and exposed velour at driveline exit sites, P=0.004. We found no significant differences in mortality, transplantation, or device explantation rates; however, there was a statistically significant increase in postimplantation hospital admissions in patients with multidrug-resistant organism infection. To our knowledge, this is the first report in the medical literature concerning multidrug-resistant organism infection in patients who have permanent left ventricular assist devices.

Left ventricular assist device driveline infections: recent advances and future goals.

Left ventricular assist devices (LVADs) have revolutionized the treatment of advanced heart failure, but infection remains a substantial risk. LVAD driveline infections (DLIs) are the most common type of LVAD-associated infection (LVADI). In the past several years we have expanded our understanding of DLI epidemiology, standardized the definition of LVADIs, improved infection rates through changes in implantation techniques, and investigated potential new modalities for DLI diagnosis. However, significant challenges remain for optimizing DLI prevention and treatment. These challenges include standardizing and improving both empiric and targeted antimicrobial therapy, expanding our understanding of effective driveline exit site dressings and topical therapies, and defining the patient population that benefits from device exchange and transplant. Additionally, in an era of expanding antibiotic resistance we need to continue investigating novel, non-antibiotic therapies for prevention and treatment of DLIs.

Ultraviolet Radiation Affects Thoratec HeartMate II Driveline Mechanical Properties: A Pilot Experiment.

Longevity and quality of life for left ventricular assist device (LVAD) patients are plagued by driveline exit site infections. Ultraviolet (UV) radiation, a current treatment in wound healing clinics, could potentially treat LVAD exit site infections. However, the effect of UV radiation on the tensile properties of HeartMate II (HMII) driveline material is unknown. The sleeve of a single HMII driveline was distributed into six exposure groups (n = 10/group). The six groups were further divided into two treatment cohorts designed to replicate wound treatment schedules of postimplant LVAD patients. Strip biaxial tensile tests were performed on both unexposed and exposed samples to analyze changes in material elasticity (Young's modulus), point of deformation (yield strength), and breaking point. Our data suggest that UV exposure changes the elasticity of the HMII driveline. However, the material endured aberrantly large forces and the properties remained within the safety threshold of device performance. This study warrants further examination of the effect of UV light on driveline material, to determine safety, reliability, and efficacy of UV treatment on exit site infections.

Invited Commentary

Despite the continuing improvement in outcomes after left ventricular assist device (LVAD) implantation, pump-related infections remain a significant challenge. Up to 50% of patients with continuous-flow LVADs will have a percutaneous driveline infection at some time after implantation. Although the incidence has decreased relative to the previous generation of pulsatile pumps, it is still very high. LVAD-associated infections are treated initially with intravenous antibiotics, and in some cases with surgical debridement of the driveline exit site, or even rarely with pump exchange, depending on the localization of infection. The long-term survival is exceedingly poor, and patients are at high risk for embolic stroke and sepsis leading to multiorgan failure. Previous studies in the era of pulsatile LVADs have demonstrated that heart transplantation with removal of all device-related material was associated with acceptable outcomes. This has not been investigated in the current era of continuous-flow devices until this study by Tong and coauthors [1Tong M.Z. Smedira N.G. Soltesz E.G. et al.Outcomes of heart transplant after left ventricular assist device specific and related infection.Ann Thorac Surg. 2015; 100: 1292-1297Abstract Full Text Full Text PDF PubMed Scopus (35) Google Scholar]. This analysis included 170 patients who underwent HeartMate II (Thoratec Corp, Pleasanton, CA) LVAD implantation as a bridge to transplantation. Sixty-one (36%) patients had an LVAD-related infection and 26 of these patients went on to heart transplantation. Patients with LVADs with or without infections had an equal likelihood at 1 year of receiving a transplant (40%), and 1-year survival to transplantation was also similar at nearly 80%. Posttransplantation survival was excellent in the cohort with LVAD-related infection, with 1- and 3-year survivals of 96% and 92%, respectively, and was not different from the group without infection. These data again demonstrate that transplantation remains the best strategy for treatment of LVAD-related infections in bridge to transplantation patients with current-generation devices. Of course the best approach to infection in these patients is prevention. This has represented a formidable challenge in the field of durable mechanical circulatory support given the presence of a percutaneous driveline; however, recent retrospective multiinstitutional studies have described driveline externalization techniques that are associated with a less than 10% incidence of exit site infection at 1 year. Longer-term follow-up, as well as a prospective arm of this study, is ongoing. Future generations of LVADs will likely eliminate the need for externalized components, and this will likely be the best solution for prevention of device-related infection. Outcomes of Heart Transplant After Left Ventricular Assist Device Specific and Related InfectionThe Annals of Thoracic SurgeryVol. 100Issue 4PreviewLeft ventricular assist device (LVAD) infections including drivelines, pump pockets, and bacteremia are difficult to manage and conservative treatments may not be effective as the infected foreign material remains. Full-Text PDF

VeraFlo Negative Pressure Wound Therapy with Household Bleach for Refractory Driveline Infection in a Patient with Left Ventricular Assist Device.

Driveline infections and sepsis are amongst the most common causes of morbidity and mortality in a patient with a left ventricular assist device. In this case, we present a patient with a multi drug resistant pseudomonas aeruginosa driveline exit site infection. Initially, it was treated with dual antibiotics, followed by surgical debridement utilizing Dakin’s solution irrigation and standard negative pressure wound therapy. Wound healing was minimal determined by poor granulation appearance, unchanged size from surgical debridement, purulent drainage, and the wound base remained colonized with multi drug resistant pseudomonas aeruginosa. A novel treatment of VeraFlo negative pressure wound therapy in conjunction with indwelling Dakin’s solution into the wound base was introduced. This treatment resulted in improved granulation appearance, decreased drainage, decreasing in wound size, with positive changes noticeable in 7 days. We suggest that the use of VeraFlo negative pressure wound therapy may be used for treatment for cumbersome driveline infections.

A Simple Education Tool for Ventricular Assist Device Patients and Their Caregivers

Ventricular assist devices (VADs) have become an important therapy in the management of patients with end-stage heart failure. Driveline infection is the most common late-onset complication in this group of patients. Patients and their caregivers require education regarding management of the driveline to reduce the risk of infection when they are discharged home with a VAD. The aim of this study was to develop an educational booklet on VAD driveline care for patients and their caregivers. A literature review was undertaken to explore the availability of patient education material pertaining to driveline management and to update evidence-informed knowledge that could potentially reduce infection rates in these patients. This information was evaluated by peers, patients, and caregivers to produce the final colored booklet. Driveline care is not comprehensively discussed in the literature and lacks detail in the particulars of wound care, patient education, and the adaptation of driveline care to the patient's home environment. An educational booklet was designed to convey what is currently known about preventing driveline infections to those who are responsible for providing the required daily care. Evaluation of patient education material by those using the material is essential. As with all written material, the information will require updating as new evidence becomes available. Managing driveline infection risk for patients at home with extended therapy is a critical nursing issue in improving morbidity and mortality. After VAD implantation, patients and caregivers must be educated about the ongoing care of the driveline exit site to minimize the risk of infection. A rigorously developed and patient-evaluated educational booklet on driveline exit site care can be a valuable reference tool for patients and caregivers after hospital discharge.

(856) - Is Heart Transplantation a Therapeutic Intervention in Multi Drug Resistant Ventricular Assist Related Infections?

Heart transplantation (HTx) remains the gold standard for refrac- tory heart failure treatment. Due to severe donor shortage in Greece, VADs are increasingly used as a “bridge” to transplant. Driveline exit site, pump pocket infections, as well as endocarditis, remain the major complications despite progress in VAD application. Traditionally, HTx is contraindicated in the presence of active infection, although HTx may be appropriate treatment for life-threatening VAD infections due to multi-drug resistant (MDR) pathogens. VAD patients were monitored for local and sys- temic signs of infection, while blood and exit site cultures were performed weekly. From February 2003 to October 2014, 15 out of 100 patients developed uncontrollable VAD related infections (15%),12 of which were successfully transplanted. One patient with Acinetobacter baumanii VAD endocarditis underwent VAD replacement with a Berlin Heart Excor BiVAD, yet he died of uncontrollable sepsis before a donor became available. MDR pathogens such as MRSA, Pseudomonas aeruginosa, Klebsiella pneumoniae,Candidas parapsilosis were isolated in blood and trauma cultures.Infection was primarily found in INTERMACS patients and in patients that exceeded 3.5 years of support. Aggressive antibiotic treatment is not adequate in VAD infection due to MDR nosococomial pathogens. Heart transplantation, evenat a pre-terminal stage, may offer reasonable chances of success.

(500) - A Weekly Dressing Protocol Reduces the Incidence of Driveline Infection

Driveline infections (DI) remain an important source of morbidity for patients supported by durable ventricular assist devices (VAD). There is no universally accepted protocol for management of the driveline exit site, and daily or thrice weekly dressing change protocols are used at many programs. Our center has utilized a standardized implant procedure and weekly outpatient driveline management protocol since 2011 with low rates of driveline infection.

INCOR® INVASTOP - Reduction of Driveline Infection Rate: Observational Prospective Study of Silicone at the Driveline Exit Site

INCOR® INVASTOP - Reduction of Driveline Infection Rate: Observational Prospective Study of Silicone at the Driveline Exit Site

Continuous flow left ventricular assist devices: shared care goals of monitoring and treating patients.

Continuous-flow left ventricular assist devices (CF-LVADs) have been clinically adopted as a long-term standard of care therapy option for patients with end-stage heart failure. For many patients, shared care between the care providers at the implanting center and care providers in the community in which the patient resides is a clinical necessity. The aims of this review are to (1) provide a rationale for the outpatient follow-up exam and surveillance testing used at our center to monitor patients supported by the HeartMate II(®) CF-LVAD (Thoratec Corporation, Pleasanton, CA) and (2) provide the protocol/algorithms we use for blood pressure, driveline exit site, LVAD alarm history, surveillance blood work, and echocardiography monitoring in this patient population. In addition, we define our partnership outpatient follow-up protocol and the "shared care" specific responsibilities we use with referring health care providers to best manage many of our patients.

A review of infections in patients with left ventricular assist devices: prevention, diagnosis and management.

Since the advent of ventricular assist devices with smaller configurations and continuous-flow technology, survival rates for patients with end-stage heart failure have dramatically improved. While the burden of infectious complications is decreased in patients on continuous-flow ventricular assist devices compared to bulkier pulsatile-flow devices, infection remains one of the most common causes of morbidity and mortality. The majority of infections occur at the driveline exit site, beginning with a disruption or trauma to the barrier between the skin and driveline and sometimes spreading deeper. Once infections develop, they can be difficult to eradicate. Depending on the degree of infection, treatment options may include local wound care, antibiotics, or surgical treatment. Preventive strategies and careful surveillance are crucial to improve patient outcomes.

Clinical management for complications related to implantable LVAD use.

More than 250 continuous flow LVADs have been implanted in Japan during the last 3 years, with 1-year survival rates of 90%. These excellent results cannot be achieved without VAD teams who know the detail of surgical techniques and perioperative management. Preoperative optimization of RV function is essential and intraoperative managements are focused on adequate balance between right and left ventricle to prevent right ventricular (RV) failure. For postoperative RV failure early institution of temporary RV mechanical support improves outcomes. Immediate CT scanning is crucial if LVAD patients complain of new neurological symptoms. When CT reveals cerebral hemorrhage, INR should be reduced as soon as possible. The driveline (DL) exit site remains a significant source of LVAD-related infections, and orientation and immobilization of the DL is important. Although vacuum assisted closure is useful to facilitate drainage and healing in pump pocket as well as DL infections, urgent heart transplantation, bridging to recovery, or pump exchange may become the only options to eradicate LVAD-related infections. Patients with continuous flow LVAD are more prone to developing de novo aortic insufficiency. Although majority of them can be managed medically, some require surgical intervention. The cause of pump thrombosis is multifactorial, including lowered INR and pump speed, and implantation techniques. It is important to exchange pumps in a timely manner either through a median sternotomy or subcostal incision in highly suspected patients indicated by elevated LDH and left-sided heart failure.

Importance of Early Appropriate Intervention Including Antibiotics and Wound Care for Device-Related Infection in Patients With Left Ventricular Assist Device

IntroductionA left ventricular assist device (LVAD) is essential for treating patients with advanced heart failure. However, LVAD-related infection is a significant cause of mortality and morbidity, with bloodstream infection (BSI) especially associated with high mortality. We investigated the incidence of infectious complications in patients who received an LVAD and evaluated the effects of early and appropriate intervention for LVAD-related infection. MethodWe retrospectively reviewed 27 consecutive patients who underwent continuous-flow LVAD (CF-LVAD; n = 16) or pulsatile-flow LVAD (PF-LVAD; n = 11) implantation at the National Cerebral and Cardiovascular Center between April 2011 and March 2013. Incidences of LVAD-related infections, such as drive-line infection in patients with CF-LVAD, cannula infection in patients with PF-LVAD, and BSI in patients with both types, were examined (follow-up period, 342 ± 229 days). The mandatory antibiotic prophylaxis protocol at our institution includes teicoplanin (400 mg) 2 days before LVAD implantation and doripenem (1000 mg) within 1 hour of skin incision. In addition, the driveline exit sites undergo sterile cleansing with diluted hydrogen peroxide and placement of an antimicrobial occlusive dressing for wound care, with dressing changes performed 2–3 times per day. ResultsMore than 90% of all patients suffered from a drive-line infection within 12 months after LVAD implantation. However, BSI developed in only 12.5% of CF-LVAD and 10% of PF-LVAD patients within 12 months (log-rank test; P = .875). ConclusionsLVAD-related infections, such as drive-line and cannula infections, were common, whereas the incidence of BSI was low in our LVAD-implanted patients. Our results highlight the importance of early and appropriate intervention including antibiotics and wound care for device-related infections for reducing the incidence of potentially fatal BSI.

Surgical heart failure treatment program - the experience of Kazakhstan

In Kazakhstan, geographical and cultural reasons do not favor the development of heart transplant activity. Thus, a surgical program for treatment of advanced, refractory heart failure was implemented, focusing the efforts on ventricular assist device (VAD) therapy. The program, supported and funded by the national healthcare system, is based on a single, highly specialized surgical Center for the operation, and on a regional infrastructure for outpatient follow-up. Regional VAD coordinators are educated by the National Center. They are in charge of regular patient check, anticoagulant and antiplatelet treatment prescription, and continuing patients' and caregivers' education, mainly regarding driveline exit site dressing and driveline stabilization. From November 2011 to November 2013, 95 patients received 100 devices, mainly for left ventricular support (LVAD): HeartMate II, n=70, HeartWare, n=25. Mean age was 49.5 years, and 87.37% of the patients were males. Most patients had INTERMACS profile 4 (55%), followed by 3 and 2 (17% each). Symptomatic and functional improvement are testified by changes from baseline to month 3 of NYHA functional class (from III-IV to I-II), results of the 6-min walk test (from 152 to 440 m), and NT-proBNP levels (from 6997 to 1126 pg/ml). Overall 1-year survival was 69%, with a trend for outcome improvement over time and a relationship with preoperative INTERMACS profile (1-year survival of 60% in patients with INTERMACS profile 1-2 vs 75% in those with INTERMACS profile 3-4). In summary, where and when a heart transplant program cannot be implemented, LVAD represents a realistic therapeutic alternative. The key points for a successful VAD program are a dedicated, highly specialized multidisciplinary team at the Cardiac Surgery Center, an infrastructure throughout the country for coordinated outpatient follow-up, adequate reimbursement for this activity, and support by the healthcare system.

A simple device to secure ventricular assist device driveline and prevent exit-site infection

Driveline infections are one of the most common and important complications in patients with left ventricular assist device (LVAD). One of the causes favouring the development of this complication is the traumatism of the exit site, which occurs in response to movement of the driveline. In this work, we present a simple and feasible method to immobilize the driveline at the level of the exit site. From April 2013 until November 2013, 6 patients underwent implantation of HeartWare LVAD (HVAD) for an end-stage heart failure. When the patient has begun to mobilize after the implantation of the device, we have combined the use of two components with the aim of securing the driveline to the patient's skin: a StatLock system and a silicone suture. No case of local traumatism and no case of local infection at the driveline were observed during the follow-up. No patient reported pain or swelling at the driveline exit site. All patients were satisfied with their quality-of-life and they do not report any limitations in their daily activities. One of the major long-term complications in patients with LVAD is the development of infections of the exit site of the driveline. The trauma of this skin region promotes the onset and maintenance of an inflammatory process and local infectious. Avoiding excessive mobilization of the driveline is likely to reduce the incidence of infections of the exit site and improve the quality-of-life.

Ventricular Assist Device Driveline Infection: Treatment With Platelet-Rich Plasma

We report a case of autologous platelet-rich plasma (PRP) application over the driveline site of a left ventricular assist device (LVAD) to treat an infection. The patient, a 47-year-old man with end-stage dilated cardiomyopathy, underwent Jarvik 2000 implantation through a median sternotomy. A pedestal with power supply and LVAD control was implanted into the mastoid bone. Retroauricular wound dehiscence occurred, and PRP was applied over the wound. Normal healing of the driveline exit site was observed. PRP can be used at a driveline exit site to either prevent or treat wound infection.

Driveline Exit Site in Long Term LVAD’s – Patient Choice or Surgeon’s Decision

Purpose We started implanting long term LVADs in July 2009 and have implanted 91 devices in 85 patients. As part of the LVAD implantation planning process, discussions with patients regarding driveline exit site have been part of the routine patient consent process. We have offered patients the choice of driveline exit site as a strategy to minimise driveline misery and dissatisfaction with VAD therapy. This strategy has been retrospectively analysed by a questionnaire. Methods and Materials In November 2012, 46 patients, previously discharged and living successfully at home, were sent a questionnaire to ascertain right or left handedness, driveline exit site side and happiness with their decision to have undergone LVAD therapy. Results We received responses from 46 patients (100% response rate). There were 40 male patients (87%), and 6 female patients (13%), with an age range 19 - 66 yrs. Of note 30 (65%) patients were on the transplant waiting list. Range of time on support 3.35 years – 0.16 years. Mean time on support was 1.58 years. Total time on support was 72.48 years. All drivelines are situated in horizontal line with the umbilicus. When questioning the 46 patients on their decision to have an LVAD 43 (94%) were content with their decision. 1 (2%) was undecided 2 (4%) patients were unhappy with their decision. Conclusions Overall patient satisfaction with their decision to have LVAD therapy was high (94%). Patient decisions on driveline exit site position produced high levels of satisfaction in accepting and dealing with drivelines. The preference for driveline exit site to be the opposite of the hand dominance seemed most likely to produce highest levels of contentment. Empowering patients by allowing them to decide on their driveline exit site rather than surgeons deciding on the position may increase patient satisfaction. Driveline exit site and happiness Number of patients Drineline Right Exit site Happy with position Driveline Left Exit site Happy with position Right Handed 36 1 1 (100%) 1 (100%) 35 (100%) Left Handed 10 6 6 (100%) 6 (100%) 2 (50%)

The Effect of Percuatneous Lead Placement on Drive Line Exit Site Infections in HeartMate II Patients

Purpose It has been suggested that aligning the junction of the silicon exterior of the HeartMate II drive line and the flocked portion of the lead with skin level, “Buried”, as opposed to leaving 2-3 inches of the flocking exposed above the skin, “Unburied” reduced DLES infections. Thus, we examined DLES infection rates and causes in a single center, retrospective, non-randomized review. Methods and Materials We compared DLES infection incidence, cause of infection (poor wound healing vs. trauma), time to 1st infection, requirement for advanced measures with the 2 DLES placements in Thoratec HeartMate II recipients. Statistical comparisons were performed using Statica (Statsoft). For this study, we defined a DLES infection as at least one positive wound culture. Results Figure 1 shows the freedom from DLES infections for the 2 approaches. Significantly more, 33% (16/48)) of Unburied had DLES infections than 18% (17/94) of Buried, and the infection duration was longer, 500 vs. 175 days, respectively. The average time to 1st infection was significantly longer, 13 months, for the Unburied vs 7 months for the Buried, related to cause of infection: poor wound healing in 59% of the Buried DLES infections (10/17) vs. 38% (6/16) for the Unburied. Of the 16 Unburied DLES infections, 11 required wound vac, 7 surgical revision, and 3 pump replacements, vs. 9, 7, and 0 respectively for the Buried approach. Conclusions Using the Buried approach may reduce the incidence, severity, and duration of DLES infection, yet, a portion of patients still develop DLES due to poor wound healing and trauma. Alternative approaches to the drive line are likely needed to eliminate this pernicious source of LVAD infections.

Endoscopic tunneling of HeartMate II left ventricular assist device driveline

FIGURE 1. The endoscope is introduced into the inferior pump pocket (1) and then tunneled through the muscular abdominal wall (2) to the counterincision (3). After placing the umbilical tape, the endoscope is then placed into the counterincision, and tunneled across the abdomen (4), either below or above the umbilicus, to the driveline exit site (5), which is situated well above the beltline. Current generation ventricular assist devices require a driveline to connect the intracorporeal device to the extracorporeal controller and batteries. Recent experience has suggested anecdotally that a longer subdermal driveline tunnel without any external velour may reduce driveline infections. To accomplish this, a long, sharp C-shaped tunneler traverses the abdominal wall blindly from the right upper quadrant to an exit site on the left upper quadrant. We recently placed a driveline that entered the peritoneal cavity inadvertently while using the standard tunneling technique. As indications for placement of these devices expand to include sick and elderly patients, more patients will have had previous abdominal incisions and/or cachexia with little preperitoneal or subdermal adipose tissue. These factors can make blind placement of drivelines more hazardous. Therefore, we developed a simple, cost-effective technique using our current endoscopic saphenous vein harvesting system that allows direct visualization and safe placement of the driveline. We report this experience after receiving approval from the Cleveland Clinic’s institutional review board.