Driveline Exit Site Research Articles

Clinical outcomes of modified left ventricular assist device driveline management.

Left ventricular assist devices (LVADs) are implanted in patients with heart failure to support cardiac circulation. However, no standardized methods have been established for LVAD driveline exit site management for the prevention of infections. Therefore, this study evaluated the efficacy of modified driveline management compared with that of conventional driveline management. We retrospectively assessed the outcomes of 262 patients who underwent continuous-flow LVAD implantation between January 2005 and March 2023 at Osaka University in Japan. In conventional driveline management, an LVAD driveline penetrates the skin along the body surface and is fixed near the penetration site (n = 224). In contrast, in our modified fixation method, the LVAD driveline vertically penetrates the skin to prevent ischemia at the driveline exit site and is fixed at a distant abdominal site to prevent the movement of the driveline exit site due to body movement (n = 38). The rates of freedom from LVAD driveline infection in patients with conventional driveline management were 86, 75, and 63% at 1, 2, and 3years after LVAD implantation, respectively. The rate of freedom from LVAD driveline infection in patients managed by the modified fixation method was 91% at 1, 2, as well as 3years after LVAD implantation. The freedom rates from LVAD driveline infection in the patients with modified fixation method was lower than in the patients with the conventional method (p = 0.04). Our study revealed that the modified fixation method may offer the possibility for preventing LVAD driveline infection.

Mechanical Characterization of Anchoring Devices for the Prevention of Driveline Infection in Left Ventricular Assist Device Patients.

Driveline infection (DLI) is associated with increased mortality and morbidity in left ventricular assist device (LVAD) patients. Because trauma to the driveline exit-site (DLES) is a risk factor for DLI, adhesive anchoring devices are used to immobilize the DL. In this study, commonly used products (identified through literature review and contact with nine international VAD implantation centers) were mechanically characterized to evaluate their effectiveness in preventing DLES trauma. Eight devices were tested in an in vitro abdominal model of the DLES, where a tensile force (10 N) was applied to a HeartMate 3 DL, whereas the resulting force ( FTotal ) on the DLES was recorded using a three-axis load cell. Four devices (CathGrip: FTotal = 2.1 ± 0.4 N, Secutape: FTotal = 2.6 ± 0.3 N, Hollister: FTotal = 2.7 ± 0.5 N, Tubimed: FTotal = 2.9 ± 0.2 N) were significantly ( p < 0.05) better at preventing tensile forces at the DLES compared to the other four devices (Main-Lock: FTotal = 3.7 [0.7] N, Secutape sensitive: FTotal = 3.9 ± 0.4 N, Foley Anchor: FTotal = 4.3 ± 0.5 N, Grip-Lok: FTotal = 5.4 ± 0.8 N). Immobilization of the DL with each anchoring device resulted in lower tensile force on the DLES than without an anchor ( FTotal = 8.2 ± 0.3 N). In conclusion, the appropriate selection of anchoring devices plays a critical role in reducing the risk of DLI, whereas the CathGrip, Secutape, Hollister, or Tubimed were superior in preventing trauma to the DLES in this study.

Driveline infections in left ventricular assist devices-Incidence, epidemiology, and staging proposal.

Driveline infections (DLI) are a serious complication in patients with left ventricular assist devices (LVAD). Apart from the differentiation between superficial and deep DLI, there is no consensus on the classification of the severity of DLI. Little is known about risk factors and typical bacteria causing DLI in centrifugal-flow LVADs. In this single-center study with 245 patients, DLI were classified by their local appearance using a modification of a score suggested by the Sharp Memorial group. The driveline exit site was inspected routinely every 6 months. Severe DLI were detected in 34 patients (15%) after 6 months and in 24 patients (22%) after 24 months. The proportion of patients with DLI increased significantly during the follow-up (p = 0.0096). The most common bacteria in local smears were Corynebacterium, coagulase-negative Staphylococcus, and Staphylococcus aureus. Fifty-nine patients were hospitalized more than once for DLI. In these patients, S. aureus was the most common bacterium. It was also the most common bacterium in blood cultures. Higher BMI, no partnership, and a HeartMate 3 device were identified as risk factors for DLI in a multivariable cause-specific Cox regression. This study is a standardized analysis of DLI in a large cohort with centrifugal-flow LVADs.

Driveline dressings used in heartmate patients and local complications: A retrospective cohort

BackgroundPatients with long-term ventricular assist devices (VAD) are predisposed to infection, bleeding, and pressure injuries at the insertion of the driveline. There is no consensus on a driveline dressing protocol. Chlorhexidine is often used to clean the driveline exit site and has been associated with lower rates of infection. For driveline coverage, bacteriostatic agents and transparent film have shown good results, but are costly. The same issue was associated with anchorage devices. ObjectivesThe purpose of this study was to evaluate the types of dressings used in the driveline of patients using HeartMate (HM) and to describe the incidence density of local complications (infection, bleeding, and pressure injury) within 30 days postoperatively. MethodsA retrospective cohort study was conducted and included 22 patients admitted to the Intensive Care Unit after implantation of HM II and III in a Brazilian private hospital. ResultsSeveral types of dressings were used in the drivelines. There were 22 different types of dressings. Dressing type 6 (Chlorhexidine, Excilon, Gauze and IV3000) were the most used (45.4%). Subjects using the Flexi-Trak anchoring device had a higher rate of local bleeding (50.0%) and those who used the Hollister device had more infection (61.1%) and pressure injury associated with a medical device (11.1%), compared to others. Infection was the primary complication (45.4%), followed by local bleeding (27.7%). ConclusionDespite the high variability of products used in the driveline of patients using HeartMate, the dressing made with chlorhexidine, silver-impregnated absorbent foam and transparent film, and the use of anchoring devices was the most frequently used. Infection was the most common complication.

Dynamics of bacterial pathogens at the driveline exit site in patients with ventricular assist devices: A prospective, observational, single-center cohort study

Driveline infections (DLIs) at the exit site are frequent in patients with left ventricular assist devices (LVADs). The dynamics from colonization to infection are yet to be investigated. We combined systematic swabbing at the driveline exit site and genomic analyses to study the dynamics of bacterial pathogens and get insights into DLIs pathogenesis. A prospective, observational, single-center cohort study at the University Hospital of Bern, Switzerland was performed. Patients with LVAD were systematically swabbed at the driveline exit site between June 2019 and December 2021, irrespective of signs and symptoms of DLI. Bacterial isolates were identified and a subset was whole-genome sequenced. Fifty-three patients were screened, of which 45 (84.9%) were included in the final population. Bacterial colonization at the driveline exit site without manifestation of DLI was frequent and observed in 17 patients (37.8%). Twenty-two patients (48.9%) developed at least one DLI episode over the study period. Incidence of DLIs reached 2.3 cases per 1000 LVAD days. The majority of the organisms cultivated from exit sites were Staphylococcus species. Genome analysis revealed that bacteria persisted at the driveline exit site over time. In four patients, transition from colonization to clinical DLI was observed. Our study is the first to address bacterial colonization in the LVAD-DLI setting. We observed that bacterial colonization at the driveline exit site was a frequent phenomenon, and in a few cases, it preceded clinically relevant infections. We also provided acquisition of hospital-acquired multidrug-resistant bacteria and the transmission of pathogens between patients.

Anti-infective characteristics of a new Carbothane ventricular assist device driveline

ObjectivesDriveline infections are a major complication of ventricular assist device (VAD) therapy. A newly introduced Carbothane driveline has preliminarily demonstrated anti-infective potential against driveline infections. This study aimed to comprehensively assess the anti-biofilm capability of the Carbothane driveline and explore its physicochemical characteristics. MethodsWe assessed the Carbothane driveline against biofilm formation of leading microorganisms causing VAD driveline infections, including Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa and Candida albicans, using novel in vitro biofilm assays mimicking different infection micro-environments. The importance of physicochemical properties of the Carbothane driveline in microorganism-device interactions were analyzed, particularly focusing on the surface chemistry. The role of micro-gaps in driveline tunnels on biofilm migration was also examined. ResultsAll organisms were able to attach to the smooth and velour sections of the Carbothane driveline. Early microbial adherence, at least for S. aureus and S. epidermidis, did not proceed to the formation of mature biofilms in a drip-flow biofilm reactor mimicking the driveline exit site environment. The presence of a driveline tunnel however, promoted staphylococcal biofilm formation on the Carbothane driveline. Physicochemical analysis of the Carbothane driveline revealed surface characteristics that may have contributed to its anti-biofilm activity, such as the aliphatic nature of its surface. The presence of micro-gaps in the tunnel facilitated biofilm migration of the studied bacterial species. ConclusionThis study provides experimental evidence to support the anti-biofilm activity of the Carbothane driveline and uncovered specific physicochemical features that may explain its ability to inhibit biofilm formation.

Epidemiology, management, and clinical outcomes of extrapulmonary Mycobacterium abscessus complex infections in heart transplant and ventricular assist device recipients

Nontuberculous mycobacteria are emerging pathogens, yet data on the epidemiology and management of extrapulmonary nontuberculous mycobacteria infections in orthotopic heart transplantation (OHT) and ventricular assist device (VAD) recipients are scarce. We retrospectively reviewed records of OHT and VAD recipients who underwent cardiac surgery at our hospital and developed Mycobacterium abscessus complex (MABC) infection from 2013 to 2016 during a hospital outbreak of MABC linked to heater-cooler units. We analyzed patient characteristics, medical and surgical management, and long-term outcomes. Ten OHT patients and 7 patients with VAD developed extrapulmonary M. abscessus subspecies abscessus infection. The median time from presumed inoculation during cardiac surgery to the first positive culture was 106 days in OHT and 29 days in VAD recipients. The most common sites of positive cultures were blood (n = 12), sternum/mediastinum (n = 8), and the VAD driveline exit site (n = 7). The 14 patients diagnosed when alive received combination antimicrobial therapy for a median of 21 weeks, developed 28 antibiotic-related adverse events, and underwent 27 surgeries. Only 8 (47%) patients survived longer than 12 weeks after diagnosis, including 2 patients with VAD who experienced long-term survival after an explantation of infected VADs and OHT. Despite aggressive medical and surgical management, OHT and VAD patients with MABC infection experienced substantial morbidity and mortality.

1801. LVAD antimicrobial prophylaxis and infections, a 12-year experience

Abstract Background The incidence of end-stage heart failure necessitating advanced cardiac therapy continues to increase in the United states. Implantable left ventricular assist devices (LVADs) represent an important modality that is utilized both as a bridge to heart transplant or as destination therapy. LVAD-associated infections, ranging from driveline exit site or pocket infections to endovascular infections, are a major complication with high mortality. Antibiotic prophylaxis at time of LVAD implantation is therefore an important strategy to mitigate infections. However, a clear surgical infection prophylaxis regimen and associated outcomes have not been reported. Methods We performed a single center, retrospective cohort study evaluating the impact of antimicrobial prophylaxis on risk of infection in patients who underwent LVAD implantation between February 2007 and June 2019 at Mayo Clinic. LVAD-specific and related infections were defined according to the International Society of Heart Lung Transplantation criteria. Single drug prophylaxis (SDP) included cefazolin only, vancomycin only, or cefazolin and vancomycin; multidrug (MDP) regimen includes either of the SDP regimens plus another antibiotic. We compared incidence of infection within 90-day and within one-year of implantation, as well as risk of C. difficile infections between the SDP and MDP cohorts. Results We reviewed 403 patients who received LVAD implantation (Table 1), 402 of had information on surgical prophylaxis. 307 (76%) patients received SDP and 95 patients (24%) received MDP. 14 patients developed an infection within 1 year of implantation (Table 2). There was no difference in the incidence of infections between SDP and MDP arms both at 90 days and 1-year post-implantation (p=0.11). The median time of infection since LVAD implantation was similar between SDP and MDP (p=0.37) arms. Incidence of C. difficile infection was not different between groups (p=0.10) (Table 3). Conclusion There was no significant difference in incidence or time to first infection, within 90-day and 1-year of implantation, between single- and multidrug antibiotic surgical prophylaxis regimens administered at the time of LVAD implantation. Future prospective trials are needed to develop a clear LVAD antibiotic prophylaxis protocol. Disclosures John C. O'Horo, Sr., MD, MPH, Bates college: Advisor/Consultant|MITRE corporation: Grant/Research Support|nferenec, Inc: Grant/Research Support.

Effect of Diabetes Mellitus on Outcomes in Patients With Left Ventricular Assist Device - Analysis of Data From a Japanese National Database.

The objective of this study is to investigate the effect of preoperative diabetes on all-cause mortality and major postoperative complications among patients with continuous-flow left ventricular assist device (LVAD) by using data from a national database. The 545 study patients who underwent primary HeartMateII implantation between 2013 and 2019 were divided into 2 groups according to their diabetes mellitus (DM) status; patients with DM (n=116) and patients without DM (n=429). First, the on-device survival and incidence of adverse events were evaluated. Second, after adjusting for patients' backgrounds, the change of laboratory data in the 2 groups were compared. Overall, on-device survival at 1, 2, and 3 years was almost equivalent between the 2 groups; it was 95%, 94%, and 91% in patients without DM, and 93%, 91%m and 91% in patients with DM (P=0.468) The incidence of adverse events was similar between 2 groups of patients, except for driveline exit site infection in the adjusted cohort. Cox proportional hazards regression analysis revealed younger age (HR: 0.98 (95% confidence interval (CI): 0.97-0.99, P=0.001) and presence of DM (HR: 1.83 (95% CI: 1.14-2.88), P=0.016) as significant predictors of driveline infection. Laboratory findings revealed no differences between groups throughout the periods. The clinical results after LVAD implantation in DM patients were comparable with those in non-DM patients, except for the driveline exit site infection.

Prophylactic negative pressure wound therapy is not effective for preventing driveline infection following left ventricular assist device implantation.

Driveline infection (DLI) following left ventricular assist device (LVAD) implantation remains an unresolved problem. Negative pressure wound therapy (NPWT) promotes wound healing by applying negative pressure on the surface of the wound. Recently, the prophylactic application of NPWT to closed surgical incisions has decreased surgical site infections in various postsurgical settings. Therefore, we evaluated the efficacy and safety of prophylactic NPWT for preventing DLI in patients with LVAD implantation. Prophylactic NPWT was provided to 50 patients who received continuous-flow LVADs as bridge-to-transplant therapy at our institution between May 2018 and October 2020 (NPWT group). The negative pressure dressing was applied immediately after surgery and retained on the driveline exit site for 7 days with a continuous application of -125 mm Hg negative pressure. The primary outcome was DLI within 1 year of LVAD implantation. We compared the rate of DLI incidence in the NPWT group with that in the historical control cohort (50 patients) treated with the standard dressing (SD) who received LVAD implantation between July 2015 and April 2018 (SD group). No severe complications were associated with the NPWT. During the follow-up period, DLI was diagnosed in 16 participants (32%) in the NPWT group and 21 participants (42%) in the SD group. The rates of DLI incidence and freedom from DLI did not differ between groups (p=0.30 and p=0.63). Prophylactic NPWT at the driveline exit site was safe following LVAD implantation. However, it did not significantly reduce the risk of DLI.

In vivo evaluation of skin integration with ventricular assist device drivelines.

Ventricular assist device (VAD) driveline exit site infection is a common complication. 3D scaffolds manufactured with highly homogeneous pores via melt electro-writing (MEW) may generate an improved skin-driveline interface which permits cellular in-growth and creates a barrier to prevent bacterial migration along the driveline tissue tunnel. This study investigated skin integration on segments of Heartmate 3 driveline: smooth polyurethane, velour, and on a custom MEW scaffold in a small animal model. Drivelines with surfaces consisting of smooth polyurethane, velour bonded to smooth polyurethane, and smooth polyurethane with a MEW scaffold sleeve were implanted percutaneously in the dorsum of 42 rats. Each rat was implanted with 2 pieces of driveline of 2 cm in length. Skin integration was assessed after 7 and 14 days. Macroscopically, velour and MEW scaffold surfaces were anchored at the driveline-skin interface while smooth polyurethane samples were not attached. The histology analyses showed epidermal migration throughout the thickness of the velour and MEW scaffold groups. Evident tissue growth around single MEW scaffold fibers resulted in full coverage of the pores, while areas of compacted fibers were apparent in the velour group. Tissue ingrowth was significantly higher in the MEW group compared to the velour group after 7 (p < 0.0001) and 14 days (p < 0.0001). Marsupialization was observed in the smooth polyurethane samples. Mechanical pull-out forces were similar between velour and MEW scaffold groups at 7 and 14 days (p > 0.05). Velour and MEW scaffolds promoted epidermal integration while smooth polyurethane drivelines did not. Fine control of MEW scaffold structure production resulted in full cellular coverage and may reduce driveline infection.

Drive line infection rate reduction by developing a fixation kit

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Continuous-flow left ventricular assist device (LVAD) therapy has become a standard therapy for patients suffering from end-stage heart failure. One of the serious adverse events during LVAD support is infection. Infections can trigger thromboembolic events, haemorrhagic cerebrovascular accidents , and are the second most common cause of death. Moreover, LVAD-related infection is the leading cause of re-admission and increases the cost of LVAD therapy considerably. Patients with an infection during LVAD support need a significantly prolonged hospital stay. Background Left ventricular assist device implantation is one of the operations that patients need special and distinctive health care, and therefore a specialized medical team has been appointed to examine these patients, but from the time the device is installed, these patients suffer from frequent infections at the drive line exit site, and therefore the responsible team faces a great challenge in combating this infection and reducing the infection rate and complications. One of the biggest problems is that we cannot find the exact type of dressing that is used to care for the exit, With the increase in the number of patients who have an infection in the drive line exit site, the team started to identify the reasons that lead to this, and it was found that failure to the fixation of the drive line is one of the biggest causes of infection, and patients reported that the movement of the drive line causes them severe pain and inflammation, which leads to many difficulties in their mobility and daily activities. Aim Reaching the best practice and reducing drive line infection rate by managing drive line fixation while increasing the number of the implanted devices. Process: The LVAD nursing team started in collecting data related to the drive line infection and some modifications were implemented according to the available resources to be used in the drive line modified fixation technique: Step 1: Our available adhesive dressings were used, and two small holes were made in the middle of it. Figure 1 Step 2: A small gauze strip was passed through the two holes to be fixed around the drive line. Figure 2 Step 3: Then a surgical blade used to make a whistling hole in the adhesive dressing to exit the drive line from it. Figure 3 Results Based on: Auditing charts and data collection it shows significant decrease in infection rates and re-admission related to drive line infection. Recommendation Develop new material for education Videos in Arabic, Follow-up handbook and Posters. Updating AHC staff with the latest driveline wound care protocol Training sessions, Case study and Simulation lab.

Nontuberculous Mycobacterial Infections Associated With Left Ventricular Assist Devices in 3 Patients.

Durable left ventricular assist devices (LVADs) provide circulatory support in patients with end-stage heart failure; however, complications include infection of the driveline exit site. Nontuberculous mycobacterial infections are rare in patients with LVADs, but they should be considered in those who have undergone device exchanges and have bacterial infections with driveline exit-site discharge but no fever or leukocytosis. We reviewed the charts of patients who had an LVAD implanted at our institution from January 2009 through December 2019, to identify those with a device-related nontuberculous mycobacterial infection. Collected data included patient demographics, premorbid conditions, infection type, previous device complications, treatment, and outcomes. We identified infections in 3 patients (mean age, 41 yr): Mycobacterium abscessus in 2 and M. chimaera in 1. All had a HeartMate II device and had undergone device exchanges for pump thrombosis or for driveline fault or infections. All presented with driveline exit-site discharge without fever or leukocytosis. The mean time between initial device implantation and diagnosis of a nontuberculous mycobacterial infection was 55 months. All 3 patients were treated with antibiotics and underwent localized surgical débridement; one underwent an additional device exchange. The M. abscessus infections disseminated, and both patients died; the patient with M. chimaera infection continued to take suppressive antibiotics. Nontuberculous mycobacterial infections are associated with high morbidity and mortality rates, warranting prompt diagnosis and treatment.

P20: Development and Testing of an External Electro-pneumatic Device For Ambulatory Counterpulsation

Purpose: The NuPulse iVAS is a minimally invasive, portable, counterpulsation platform technology that provides ambulatory circulatory support. iVAS successfully supported 81 patients in an FDA-approved feasibility trial. iVAS required implantation of a Skin Interface Device (SID 1.0, 69 mm diameter) with a large exit site (22 mm diameter) and subcutaneous ECG leads. SID 1.0 implantation required two incisions and creation of a large subcutaneous pocket (excluding small and pediatric patients) which could be obviated by an external SID. Methods: To reduce iVAS invasiveness and implant time, NuPulse redesigned the SID (SID 2.0) to be external (9.5 x 5.0 x 3.5 cm, 100 g) with surface ECG leads. The performance of SID 2.0 was compared to SID 1.0 through bench testing to regulatory standards. Results: SID 2.0 enables reduction in surgical time by 90 min, and atraumatic replacement. The pneumatic driveline exit site diameter was reduced to 5 mm (~500% reduction in area). SID 2.0 provided similar ECG microprocessing speed and results with surface ECG as the SID 1.0 with subcutaneous ECG leads. SID 2.0 is worn in a device belt, and passed human factors testing for surface ECG lead wire management and hand-free support for SID 2.0. Summary: Clinical trial experience with SID 1.0 drove design modifications to system components. The NuPulse portable counterpulsation platform will have an external SID 2.0 which improves patient safety and patient experience, while reducing surgical time and invasiveness.

P60: A decade on LVAD support

Objective: The use of left ventricular assist devices (LVADs) to support patients with end-stage heart failure (HF) has been progressively adopted over the past 2 decades, with long-term outcomes reporting 50% survival at 5 years, particularly related to development of complications on support. However, there is a paucity of information related to survival beyond 10 years. Herein, we report the case of an 85-year-old man with end stage ischemic cardiomyopathy with an 11-year continuous LVAD support as destination therapy (DT). Case Report: An 85-year-old man transferred from an outside hospital, presented to the emergency department due to concerns for a driveline infection. The patient has an 11-year-old history of HeartMate2-LVAD support as destination therapy (DT) due to an end-stage ischemic cardiomyopathy. Patient has undergone automatic implantable cardioverter defibrillator secondary to atrial fibrillation, as well as a primary coronary artery disease requiring multiple percutaneous coronary interventions, in addition to an aortic and mitral valve repair. He was last seen 2 years prior to this consultation for an external LVAD drive line replacement and a chronic infection which is under oral Cefalexin management (500mg/day). Additionally, the patient continues anticoagulation therapy (aspirin 81 mg/day; warfarin 10 mg/day) with a target INR of 2.5, and has not experienced any thromboembolic or hemorrhagic complications. On clinical evaluation, driveline insertion showed a non-tender, mild erythematous aspect, with no exudation. A CT scan of the thorax and abdomen was performed, demonstrating no involvement of deep tissues. Results: Initial echocardiographic evaluation showed a left ventricular ejection fraction of 20%, moderate-to-severely reduced right ventricular systolic function, a right atrial pressure of 15 mmHg, moderate tricuspid regurgitation, and a left ventricular end diastolic diameter of 6.5 cm. Upon physical examination the patient was warm and well-perfused with an euvolemic appearance. The LVAD settings remain steady at 9400 rpm and a 5.0 L/min flow. The driveline exit site elicited no pain at palpation, with mild erythema. Due to a sustained hemodynamic function in perspective to the patient’s end-stage heart failure, 500 mg of cefalexin/daily was continued and patient was discharged with no complications and continued monitorization. Conclusion: To the authors’ knowledge, this case represents one of longest reports of LVAD support as DT. The continuing improvement of LVAD management has led to the safe and feasible application of long-term cardiac function support as DT for patients deemed not transplant candidates. As our elderly population expands, and over 80% of patients with heart failure are older than 65 years, the role LVAD for long-term support will become more relevant, and this case reveals that safe LVAD support is possible beyond 10 years.

Remote Monitoring of Pediatric VAD Patients: Early Recognition for Improved Management

<h3>Purpose</h3> Over 50% of pediatric durable, discharge-eligible ventricular assist device (VAD) patients are discharged thereby transitioning high-risk patients to outpatient clinics. To enhance management of these patients, our center developed VAD specific content for a home monitoring iPad application (App). We hypothesized that remote monitoring via App + CardioMems Pulmonary Artery Pressure (CMEMS) could reduce risk among outpatient pediatric VAD patients. <h3>Methods</h3> VAD App parameters were developed by our VAD APRN and App company with existing technology for cardiac transplant patients. Manual data entry including VAD speed, output, power, driveline exit site (DLES) picture, residual heart failure symptoms, bleeding, and fluid status, is performed by the patient. The VAD team contacts patient and family if data has not been entered in 2+ days as these platforms are intended for daily trending to enhance remote monitoring. Continuous refinements have been made to the content based on utilization assessment by VAD team and patients. <h3>Results</h3> 13 patients have utilized the VAD App since 2019 for a total of 2519 VAD support days. Median age was 14 years (range 5-16), 7/13 had cardiomyopathy, 10 were supported on HeartMate3 and 3 with HeartWare. Of the 13 patients monitored, 7 were transplanted, 3 are alive and supported, and 2 have died (both destination therapy patients). AE's in this group represent 6 driveline related infections, 2 right heart failures, 4 arrhythmias. We have used CMEMS on 3/13 patients for 457 days of CMEMS monitoring. CMEMS remote monitoring helped recognize two separate episodes of ventricular tachycardia in a patient, allowing for early intervention. Frequent review of App data and CMEMS measurements allows for medical optimization, including diuretic and fluid management without additional clinic and inpatient encounters. Serial image monitoring of DLES directed care for early outpatient intervention of infection. <h3>Conclusion</h3> Remote monitoring in pediatric VAD patients provides more data collection, which augments care of these high-risk patients. Combined use of the App and CMEMS allows for improved optimization of heart failure medications and early recognition of high-risk events. Future study will investigate the impact on hospital admissions and acute heart failure exacerbations.

TB or Non-TB, How to Treat These Infections in a Heart Transplant Patient (That is the Question!)

<h3>Introduction</h3> Driveline exit site infections (DLESi) are common complications of left ventricular assist device (LVAD) therapy. Rarely, non-tuberculosis mycobacteria (NTB) cause such infections. We present a case showing successful treatment of a DLESi due to <i>Mycobacterium chelonae</i> which first became clinically apparent after orthotopic heart transplant (OHT). <h3>Case Report</h3> A 61-year-old male with a dilated cardiomyopathy received a Heartmate 3 LVAD followed 4 years later by OHT. Prior to OHT, no infections were reported. Two months after OHT, an abdominal wall abscess at the former driveline exit site was treated with incision and drainage. Abdominal wound drainage continued, with appearance of satellite lesions and chest wall nodules. Although initial cultures were negative, wound cultures collected 3 months later, grew <i>M. chelonae</i>. For rare NTM related DLESi, a standardized regimen is not established. Hence, commonly used macrolide, quinolone, and linezolid were started. Azithromycin was initially chosen over the more frequently studied clarithromycin due to the latter's interaction with tacrolimus. Linezolid was stopped due to pancytopenia and the ensuing susceptibility report showed quinalone resistance. As a result, the patient was functionally on macrolide monotherapy which led to a recurrence of nodules. Thus, multiple antibiotic regimens were started in succession (Figure). The final clofazimine, azithromycin, and tigecycline based regimen was clinically effective, but caused intolerable diarrhea that led to self-discontinuation of treatment after ∼9 months of therapy. He remains asymptomatic 1-year since antibiotic termination. <h3>Summary</h3> Picking an antibiotic regimen for rare, difficult-to-treat NTB related DLESi involves using the sensitivity analysis while accounting for drug-drug interactions with immunosuppressive medications. Our case demonstrates efficacy of a macrolide and clofazimine based regimen for treatment of a LVAD associated NTB infection in an OHT patient.

Driveline Infection in Left Ventricular Assist Device Patients: Effect of Standardized Protocols, Pathogen Type, and Treatment Strategy.

Driveline infection (DLI) is common after left ventricular assist device (LVAD). Limited data exist on DLI prevention and management. We investigated the impact of standardized driveline care initiatives, specific pathogens, and chronic antibiotic suppression (CAS) on DLI outcomes. 591 LVAD patients were retrospectively categorized based on driveline care initiatives implemented at our institution (2009-2019). Era (E)1: nonstandardized care; E2: standardized driveline care protocol; E3: addition of marking driveline exit site; E4: addition of "no shower" policy. 87(15%) patients developed DLI at a median (IQR) of 403(520) days. S. aureus and P. aeruginosa were the most common pathogens. 31 (36%) of DLI patients required incision and drainage (I&D) and 5 (5.7%) device exchange. P. aeruginosa significantly increased risk for initial I&D (HR 2.7, 95% CI, 1.1-6.3) and recurrent I&D or death (HR 4.2, 95% CI, 1.4-12.5). Initial I&D was associated with a significant increased risk of death (HR 2.92 (1.33-6.44); P = 0.008) when compared to patients who did not develop DLI. Implementation of standardized driveline care protocol (E2) was associated with increased 2-year freedom from DLI compared to nonstandardized care (HR 0.36, 95% CI, 0.2-0.6, P < 0.01). Additional preventive strategies (E3&E4) showed no further reduction in DLI rates. 57(65%) DLI patients received CAS, 44% of them required escalation to intravenous antibiotics and/or I&D. Presence of P. aeruginosa DLI markedly increased risk for I&D or death. Conditional survival of patients progressing to I&D is diminished. Standardized driveline care protocol was associated with a significant reduction in DLI, while additional preventive strategies require further testing.

Impella 5.0: An intermediate strategy for bridging a patient from infected durable LVAD to cardiac transplant

Cardiac transplant remains the gold-standard treatment for end-stage heart failure more than 50 years after the procedure was first pioneered. The number of transplant operations performed annually has been limited by the global imbalance of donor organs to recipients. This imbalance helped fuel the development of left ventricular assist devices (LVADs) first as a bridge to cardiac transplant and subsequently as destination therapy. Driveline infection is one of several problems that continue to plague LVADs through several generations of improvement. We present a patient with an infected LVAD driveline exit site that progressed to mediastinitis, pericardial and pump infection. The device was explanted, and the patient supported with an axillary Impella 5.0 as a bridge until the time of transplant. An Impella 5.0 (or 5.5) can be used as an intermediate tool to be able to explant an infected LVAD, with mediastinitis, allowing the patient to clear the infection, and prepare the patient for transplant free of infection. METHODS: The patient consented to the study and case report. The patient signed an informed consent and permission for publication.

948. Ventricular Assist Device Infection due to Non-tuberculous Mycobacteria Leading to Successful Heart Transplantation: A Case Report and Literature Review

BackgroundA 59-year-old man with acute myelogenous leukemia and matched allogeneic hematopoietic stem-cell transplant and non-ischemic cardiomyopathy requiring a left ventricular assist device (LVAD; HeartMate II™) was admitted after the spontaneous rupture of an abdominal fistula in his lower abdomen, and cloudy discharge from the driveline (DL) exit site for months. Figure 1 Denied systemic symptoms but had leukocytosis. CT scan of the abdomen revealed soft tissue enhancement around the LVAD DL Figure 2. Cultures from DL discharge grew Mycobacterium chelonae. He underwent incision and drainage (I&D) of the abdominal fistula, with unroofing of the tissue over the DL. Antimicrobial course is summarized in Table. He was thought to be an appropriate heart transplant candidate one month later. Cultures from the LVAD sites were negative. He completed antimicrobials for 10 weeks after transplant. 32 months after heart transplant he has no signs of M. chelonae infection. Figure 1. Driveline exit site with scant cloudy discharge and a shallow 3 x 2-centimeter open lesion inferior to the umbilicus. Driveline track in dotted line. Figure 2. CT scan of the abdomen revealed soft tissue enhancement (red arrows) around the LVAD driveline in the lower abdomen.MethodsWe performed a literature review of all published cases involving Non-Tuberculous Mycobacteria (NTM) and LVADs. Collected: date, sex and age, onset, organism, type of LVAD, transplant, surgical debridement, antimicrobials, outcome. ResultsA total of 11 patients with LVAD infection due to NTM have been described in the literature. Four cases of NTM LVAD infection culminated in heart transplantation. Cases are summarized in Table 1. All transplanted cases had an indolent presentation and driveline discharge, without systemic symptoms. All underwent I&D and/or de-roofing of the driveline and were treated with at least two active antimicrobials for an extended course ranging from 4 months and up to 17 months after transplant. All cases did well from the infection standpoint. One died within 12 months from transplant rejection. ConclusionTreatment with a combination with at least two active agents is recommended and continued for many months. Effective surgical debridement of affected tissue and unroofing of the driveline beyond the affected velour, along with the removal of the infected device at the time of cardiac transplant, is key to success.Disclosures Susan J. Rehm, MD, Lilly (Individual(s) Involved: Self): Shareholder; Merck (Individual(s) Involved: Self): Shareholder; Pfizer (Individual(s) Involved: Self): Shareholder