Driveline Infection Research Articles

Endovascular therapy for intracranial infectious aneurysms associated with a left ventricular assist device: illustrative case.

BACKGROUNDCerebrovascular events and infection are among the most common complications of left ventricular assist device (LVAD) therapy. The authors reported on a patient with an infectious intracranial aneurysm (IIA) associated with LVAD infection that was successfully occluded by endovascular therapy.OBSERVATIONSA 37-year-old man with severe heart failure received an implantable LVAD. He was diagnosed with candidemia due to driveline infection 44 months after LVAD implantation, and empirical antibiotic therapy was started. After 4 days of antibiotic treatment, the patient experienced sudden dizziness. Computed tomography (CT) revealed subarachnoid hemorrhage in the right frontal lobe, and CT angiography revealed multiple aneurysms in the peripheral lesion of the anterior cerebral artery (ACA) and middle cerebral artery. Two weeks and 4 days after the first bleeding, aneurysms on the ACA reruptured. Each aneurysm was treated with endovascular embolization using n-butyl cyanoacrylate. Subsequently, the patient had no rebleeding of IIAs. The LVAD was replaced, and bloodstream infection was controlled. He received a heart transplant and was independent 2 years after the heart transplant.LESSONSLVAD-associated IIAs have high mortality and an increased risk of surgical complications. However, endovascular obliteration may be safe and thus improve prognosis.

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.

Preventing driveline infection during left ventricular assist device support by the HeartMate 3: A survey-based study.

Driveline infection (DLI) is a significant source of morbidity and mortality during left ventricular assist device (LVAD) support yet limited studies are available to describe the center-level prevalence, preventive practices, and their potential effectiveness. We surveyed LVAD centers in the United States to determine program burden and preventive practices for DLI during HeartMate (HM) 3 support. An online, anonymous, question-based survey was sent to expert providers at implanting centers. Only a single respondent completed the survey for each center. As an exploratory analysis, we compared specific DLI preventive practices between centers with low (≤10%) and high (>10%) reported prevalence of DLI. Seventy-eight centers responded to the survey (response rate: 50%). Respondents were comprised of 37 (47%) heart failure cardiologists, 27 (35%) LVAD coordinators, and 14 (18%) cardiothoracic surgeons. The prevalence of DLI during HM3 was reported as ≤10% by 27 (35%), 11%-25% by 36 (46%), and >25% by 16 (19%) centers. Thirteen (17%) centers had a body mass index threshold for device placement, 29 (37%) utilized a counter incision, 66 (81%) placed an anchor stitch, and 69 (88%) used an external device to stabilize the DL. Proportionally, more centers with a low DLI prevalence used a wound vacuum 6 (22%) versus 3 (6%, p=0.03) than those with high DLI. Variation exists in reported prevalence and practices of preventing and managing driveline infections across centers during HM3 support. Further studies are warranted to develop and assess the effectiveness of standardized preventive strategies.

Impact of the HeartMate 3 continuous-flow left ventricular assist device in patients with small body size.

OBJECTIVESLimited data are available for use of the HeartMate 3 (HM 3) left ventricular assist device in patients with a small body surface area (BSA). Because the HM 3 is currently the sole device available worldwide, we conducted a single-centre retrospective study of patients with a small BSA (<1.5 m2) who underwent HM 3 implantation to better understand the operative and postoperative management.METHODSThis study enrolled 64 consecutive patients who had undergone HM 3 implantation from August 2018 to July 2021. The patients were divided into 2 groups based on their BSA before the operation: BSA of <1.5 m2 (small BSA group, n = 18) and BSA of ≥1.5 m2 (regular BSA group, n = 46). The primary study endpoint was survival free of events such as disabling stroke and pump failure. The secondary endpoint was the frequency of adverse events.RESULTSThe average BSA was 1.38 m2 in the small BSA group. The overall event-free survival rate at 12 months was 100% and 86.7% in the small BSA group and regular BSA group, respectively, and no significant difference was found between the 2 groups (log-rank P = 0.2). The number of cumulative adverse events of death, stroke of any severity, driveline infection, pump infection, ventricular arrhythmia, gastrointestinal Haemorrhage and pump failure was similar between the 2 groups.CONCLUSIONSThe HM 3 was safely implanted in patients with a small BSA, and postoperative outcomes were acceptable regardless of BSA. However, further research is needed to confirm the indications for HM 3 implantation in even smaller patients.

Patient factors associated with left ventricular assist device infections: A scoping review

Infections are widely prevalent in left ventricular assist device (LVAD) recipients and associated with adverse events including mortality and rehospitalizations. Current evidence examining factors associated with infections in this setting predominantly comprises single-center observational data. We performed a scoping review to systematically summarize all existing studies examining patient-related factors associated with infections after LVAD implantation. Studies published between 01/06 and 02/19 were identified through searching 5 bibliographic databases: PubMed, Scopus, EMBASE, CINAHL, and Web of Science Core Collection. Inclusion criteria required examination of patient-related factors associated with infections among recipients of contemporary implantable, continuous flow LVADs. Key study characteristics were extracted by four independent reviewers and current literature described narratively. All analyses took place between February 2019 and May 2021. A total of 31 studies met inclusion criteria. All included studies were observational, and most commonly focused on driveline infections (n=17). Factors studied most commonly included body composition (n=8), diabetes and other comorbidities (n=8), and psychosocial/socio-economic factors (n=6). Studies were frequently single-center with heterogeneity in definition of infectious outcomes as well as exposure variables. Patient race and sex did not correlate with infection risk. There was no consistent association noted between obesity, diabetes, or psychosocial/socio-economic factors and infections in LVAD recipients. Two studies reported a significant association between malnutrition and hypoalbuminemia and post implant infections. This review summarizes 31 studies that described patient-related factors associated with infection after LVAD implantation. Patient related comorbidities, especially body composition and diabetes, were most commonly evaluated, but were not consistently associated with infections after LVAD implantation.

Long-Term Follow-Up of Mechanical Circulatory Support in Peripartum Cardiomyopathy (PPCM) Refractory to Medical Management: A Multicenter Study.

Background: Peripartum cardiomyopathy (PPCM) is a rare, life-threatening form of heart disease, frequently associated with gene alterations and, in some cases, presenting with advanced heart failure. Little is known about ventricular assist device (VAD) implantation in severe PPCM cases. We describe long-term follow-up of PPCM patients who were resistant to medical therapy and received mechanical circulatory support or heart transplant. Methods and results: A total of 13 patients were included with mean follow-up of eight years. Mean age of PPCM onset was 33.7 ± 7.7 years. All patients were initially treated with angiotensin-converting enzyme inhibitors and beta-blockers, and four received bromocriptine. Overall, five patients received VADs (three biventricular, two isolated left ventricular) at median 27 days (range: 3 to 150) following childbirth. Two patients developed drive line infection. Due to the short support time, none of those patients had a stroke or VAD thrombosis. In total, five patients underwent heart transplantation, of which four previously had implanted VADs. Median time to transplantation from PPCM onset was 140 days (range: 43 to 776), and time to transplantation from VAD implantation were 7, 40, 132, and 735 days, respectively. All patients survived until most recent follow up, with the exception of one patient who died following unrelated abdominal surgery two years after PPCM recovery. Conclusions: In patients with severe, life-threatening PPCM refractory to medical management, mechanical circulatory support with or without heart transplantation is a safe therapeutic option.

Degenerative changes of the aortic valve during left ventricular assist device support.

AimsDonor heart shortage leads to increasing use of left ventricular assist device (LVAD) as bridge‐to‐transplant or destination therapy. Prolonged LVAD support is associated with aortic valve insufficiency, representing a relevant clinical problem in LVAD patients. Nevertheless, the impact of LVAD support on inflammation, remodelling, and chondro‐osteogenic differentiation of the aortic valve is still not clearly understood. The aim of the study is to evaluate the impact of LVAD support on structural and molecular alterations of the aortic valve.Methods and resultsDuring heart transplantation, aortic valves of 63 heart failure patients without (n = 22) and with LVAD support (n = 41) were collected and used for analysis. Data on clinical course as well as echocardiographic data were analysed. Calcification and markers of remodelling, chondro‐osteogenic differentiation, and inflammation were evaluated by computed tomography, by mRNA analysis and by histology and immunohistochemistry. Expression of inflammation markers of the LVAD group was analysed with regard to levels of C‐reactive protein and driveline infections. Calcium accumulation and mRNA expression of determined markers were correlated with duration of LVAD support. Data were also analysed relating to aortic valve opening and aortic valve insufficiency. There was no difference in the frequency of cardiovascular risk factors or comorbidities between the patient groups. Expression of matrix metalloproteinase‐9 (P = 0.007), alpha‐smooth muscle actin (P = 0.045), and osteopontin (P = 0.003) were up‐regulated in aortic valves of LVAD patients. Histological appearance of the aortic valve was similar in patients with or without LVAD, and computed tomography‐based analysis not yet revealed significant difference in tissue calcification. Expression of interferon gamma (P = 0.004), interleukin‐1 beta (P < 0.0001), and tumour necrosis factor alpha (P = 0.04) was up‐regulated in aortic valves of LVAD patients without concomitant inflammatory cell infiltration and independent from unspecific inflammation. Expression of matrix metalloproteinase‐2 (P = 0.038) and transforming growth factor beta (P = 0.0504) correlated negatively with duration of LVAD support. Presence of aortic valve insufficiency led to a significantly higher expression of interferon gamma (P = 0.007) in LVAD patients. There was no alteration in the determined markers in relation to aortic valve opening in LVAD patients.ConclusionsLeft ventricular assist device support leads to signs of early aortic valve degeneration independent of support duration. Thus, the aortic valve of patients with LVAD support should be closely monitored, particularly in patients receiving destination therapy as well as in the prospect of using aortic valves of LVAD patients as homografts in case of bridge‐to‐transplant therapy.

Driveline Features as Risk Factor for Infection in Left Ventricular Assist Devices: Meta-Analysis and Experimental Tests.

Background: Risk factors for driveline infection (DLI) in patients with left ventricular assist devices are multifactorial. The aim of this study was to analyze the correlation between mechanical driveline features and DLI occurrence.Methods: A meta-analysis was conducted that included studies reporting DLI rates at 6 months after implantation of any of three contemporary devices (HVAD with Pellethane or Carbothane driveline, HeartMate II, and HeartMate 3). Further, outer driveline diameter measurements and ex-vivo experimental three-point bending and torsion tests were performed to compare the stiffness of the four different driveline types.Results: 21 studies with 5,393 patients were included in the meta-analysis. The mean weighted DLI rates ranged from 7.2% (HeartMate II) to 11.9% (HeartMate 3). The HeartMate II driveline had a significantly lower maximal bending force (Loadmax) (4.52 ± 0.19 N) compared to the Carbothane HVAD (8.50 ± 0.08 N), the HeartMate 3 (11.08 ± 0.3 N), and the Pellethane HVAD driveline (15.55 ± 0.14 N) (p < 0.001). The maximal torque (Torquemax) of the HeartMate II [41.44 (12.61) mNm] and the Carbothane HVAD driveline [46.06 (3.78) mNm] were significantly lower than Torquemax of the Pellethane HVAD [46.06 (3.78) mNm] and the HeartMate 3 [95.63 (26.60) mNm] driveline (p < 0.001). The driveline of the HeartMate 3 had the largest outer diameter [6.60 (0.58) mm]. A relationship between the mean weighted DLI rate and mechanical driveline features (Torquemax) was found, as the the HeartMate II driveline had the lowest Torquemax and lowest DLI rate, whereas the HeartMate 3 driveline had the highest Torquemax and highest DLI rate.Conclusions: Device-specific mechanical driveline features are an additional modifiable risk factor for DLI and may influence clinical outcomes of LVAD patients.

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.

644 Clinical outcomes of patients with end-stage heart failure treated with left ventricular assist devices

Abstract Aims During the last decades left ventricular assist devices (LVAD) have assumed a central role in the management of patients with symptomatic end-stage heart failure (HF). The mortality rate and prognosis of these patients is poor, but the substantial progress in LVAD technologies has led to significant improvements in clinical outcomes. The third generation LVADs are small, centrifugal flow pumps, contained within the pericardium and based on full magnetic levitation, which allow to reduce the risks of pump thrombosis. The aim of our study is to evaluate the clinical outcomes and functional capacity of patients with end-stage HF before and after the implantation of a third generation LVAD, the HeartMate 3™. Methods and results We evaluated eight patients with end-stage HF, followed to Cardiology Unit of Brotzu Hospital in Cagliari and consecutively implanted with the HeartMate 3™ LVAD in the Cardiac Surgery Unit from 12 May 2017 to 24 October 2019. For each patient we collected socio-demographic and clinical features, as well as laboratory tests, therapy, echocardiographic and haemodynamics parameters and any complication. Most of our patients were male (87.5%), with mean age 65.6 ± 5.7 years and higher prevalence of cardiovascular risk factors, like smoke (87.5%), hypertension (62.5%) and hypercholesterolaemia (62.5%). The etiology of HF was mainly due to idiopatic dilated cardiomyopathy (62.5%) and ischaemic heart disease (25%); the only female patient had a history of iatrogenic dilated cardiomyopathy, post-chemo and radiotherapy. Before the implantation most of our patients experienced severe symptoms, recurrent decompensations resulting in NYHA class IV (50%) and III (37.5%); the 100% was inotrope dependant and needed short-term support devices like IABP (75%) and ECMO (25%); the 62.5% underwent mechanical ventilation. The patients had severe left ventricular (LV) dysfunction, with low LV ejection fraction (18.6 ± 1.8%), cardiac output (3.08 ± 1.2 l/min) and cardiac index (1.81 ± 0.83 l/min/m2) and increasing filling pressure (26.5 ± 9.7 mmHg), central venous pression (12.7 ± 5 mmHg) and pulmonary arteries resistance (3.81 ± 1 μW). We also found important LV structural changes, with a severe dilatation and increased volumes (EDV 140.62 ± 67.1 ml/m2; ESV 113.7 ± 55.3 ml/m2). Mild right ventricle dysfunction was present only in 50% of patients with normal diameters. We observed few complications, mainly driveline infections (42.8%) and only one case of in-hospital mortality due to multiple organ failure. The seven patients presenting at FU shown a significant improvement in everyday symptoms and functional capacity compared to pre-operative features (P = 0.029). We also found a mild improvement of systolic LV function compared to pre-operatory values, with increase of CO (3.58 ± 0.65 l/min vs. 3.08 ± 1.2) and EF (21.2 ± 9.4% vs. 18.71 ± 97) even though not statistically significant. Conclusions Our study confirms that patients with end-stage HF are mostly male, older, experience severe symptoms and require frequent hospitalizations. The survival rate reached the 87.5% and remained stable even three years after implantation. On the whole our study showed that LVADs can significally improve clinical outcomes and survival rates, confirming the role as treatment of choice for many patients with end-stage HF who cannot undergo heart transplantation, which still remains the gold standard. The complications related to LVAD were few, thanks to careful patients selection, showing a favourable risk benefit ratio.

183. Management of Left Ventricular Assist Device Infections at a Large Academic Medical Center

Abstract Background Left ventricular assist device infections (LVADIs) contribute significantly to morbidity and mortality. The lack of evidenced-based treatment recommendations results in substantial variability in clinical practice. The purpose of this study was to evaluate the management of LVADIs at our institution to better assess practice patterns and standardize treatment decisions. Methods This was a retrospective study including adults diagnosed with an initial LVADI from January 1, 2013 to July 1, 2019. Exclusion criteria included concomitant non-LVADI, patients with other mechanical circulatory systems, or pregnancy. Pertinent patient, LVAD, infection, management, and clinical outcome data was collected and described with descriptive statistics. Results A total of 49 patients were included, 37 of which had at least one recurrence, resulting in 57 recurrent and 106 total LVADIs. The majority of LVADIs were driveline infections (DLIs) (92%). There was an increase in the incidence of deep DLIs (35% vs. 10%) and bloodstream infections (26% vs. 4%) amongst recurrent vs. initial LVADIs. Staphylococcus aureus (51%) and nosocomial gram-negatives (20%) were the most common causative pathogens. Surgical interventions were common (55%). LVADIs treated predominately with oral antibiotics (54%) or IV antibiotics (46%) received a median duration of therapy of 31 and 35 days, respectively. Antibiotic regimens included anti-methicillin-resistant S.aureus coverage and anti-pseudomonal coverage in 49% and 22% of total cases, respectively. Suppressive antibiotics were commonly prescribed (54%). LVADI-related readmission (69%) and recurrence (76%) within one year of initial LVADI was frequent. Recurrent LVADI occurred regardless of receiving suppressive therapy in 60% of total recurrent cases. Conclusion This study offers unique insight into initial vs. recurrent LVADIs as well as infection characteristics and clinical outcomes at a large academic medical center. Future studies with additional focus on risk factors for recurrence would be beneficial for drawing conclusions on the efficacy of current practices and shaping future treatment guidelines. Disclosures All Authors: No reported disclosures

Identifying Causative Microorganisms in Left Ventricular Assist Device Infections as a Guide for Developing Bacteriophage Therapy

As more left ventricular-assist devices (LVADs) are implanted, multidrug-resistant LVAD infections are becoming increasingly common, partly due to bacterial biofilm production. To aid in developing bacteriophage therapy for LVAD infections, we have identified the most common bacterial pathogens that cause LVAD driveline infections (DLIs) in our heart transplant referral center. We studied a retrospective cohort of patients who received LVADs from November 2003 to August 2017 to identify the common causative organisms of LVAD infection. We also studied a prospective cohort of patients diagnosed with DLIs from October 2018 to May 2019 to collect bacterial strains from DLIs for developing bacteriophages to lyse causative pathogens. LVAD infections were classified as DLI, bacteremia, and pump/device infections in the retrospective cohort. In the retrospective cohort of 582 patients, 186 (32.0%) developed an LVAD infection, with 372 microbial isolates identified. In the prospective cohort, 96 bacterial strains were isolated from 54 DLIs. The microorganisms causing DLIs were similar in the two cohorts; the most common isolate was Staphylococcus aureus. We identified 6 prospective S. aureus strains capable of biofilm formation. We developed 3 bacteriophages that were able to lyse 5 of 6 of the biofilm-forming S. aureus strains. Similar pathogens caused LVAD DLIs in our retrospective and prospective cohorts, indicating our bacterial strain bank will be representative of future DLIs. Our banked bacterial strains will be useful in developing phage cocktails that can lyse ≥80% of the bacteria causing LVAD infections at our institution.

Competing Risks to Transplant in Bridging With Continuous-flow Left Ventricular Assist Devices

BackgroundContinuous-flow left ventricular assist device (CF-LVAD) support is a mainstay in the hemodynamic management of patients with end-stage heart failure refractory to optimal medical therapy. In this report we evaluated waitlist complications and competing outcomes for CF-LVAD patients compared with primary transplant candidates listed for orthotopic heart transplantation at a single center. MethodsAll patients listed for orthotopic heart transplantation between 2006 and 2020 at our institution were retrospectively reviewed (CF-LVAD, 300; primary transplant, 244). Kaplan-Meier methodology with log-rank testing was used to evaluate survival outcomes. Terminal outcomes of death, delisting, and transplant were assessed as competing risks and compared between groups using Gray’s test. Multivariable Fine-Gray regression was used to identify predictors of transplantation. ResultsOne-year rates of transplant, delisting, and death were 48%, 8%, and 2%, respectively, for CF-LVAD patients and 45%, 15%, and 9%, respectively, for primary transplant (all P < .001). Waitlist mortality at 5 years was 4% among CF-LVAD patients and 13% for primary transplants. All-cause mortality after listing was lower for CF-LVAD patients (P = .017). There was no difference in posttransplant survival between groups (P = .250). On multivariable Fine-Gray regression stroke (P = .017), respiratory failure (P = .032), right ventricular failure (P = .019), and driveline infection (P = .050) were associated with decreased probability of transplantation. Posttransplant survival was not significantly worse for CF-LVAD patients who experienced device-related complications (P = .901). ConclusionsAlthough device-related complications were significantly associated with decreased rates of transplant, CF-LVAD patients had excellent waitlist outcomes overall. In light of the 2018 allocation score change the risk of complications should be taken into account when deciding whether to offer CF-LVAD as a bridge to transplant.

Mortality following durable left ventricular assist device implantation by timing and type of first infection

ObjectiveAlthough infections are common after left ventricular assist device implantation, the relationship between timing and type of first infection with regard to mortality is less well understood. MethodsThe Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support patients receiving a primary left ventricular assist device from April 2012 to May 2017 were included. The primary exposure was defined 3 ways: any infection, timing of first infection (early: ≤90 days; intermediate: 91-180 days; late: >180 days), and type (ventricular assist device specific, ventricular assist device related, non–ventricular assist device). The association between first infection and all-cause mortality was estimated using Cox regression. ResultsThe cohort included 12,957 patients at 166 centers (destination therapy: 47.4%, bridge-to-transplant: 41.2%). First infections were most often non–ventricular assist device (54.2%). Rates of first infection were highest in the early interval (10.7/100 person-months). Patients with any infection had a significantly higher adjusted hazard of death (hazard ratio, 2.63; 2.46-2.86). First infection in the intermediate interval was associated with the largest increase in adjusted hazard of death (hazard ratio, 3.26; 2.82-3.78), followed by late (hazard ratio, 3.13; 2.77-3.53) and early intervals (hazard ratio, 2.37; 2.16-2.60). Ventricular assist device–related infections were associated with the largest increase in hazard of death (hazard ratio, 3.02; 2.69-3.40), followed by ventricular assist device specific (hazard ratio, 2.92; 2.57-3.32) and non–ventricular assist device (hazard ratio, 2.42; 2.20-2.65). ConclusionsRelative to those without infection, patients with any postimplantation infection had an increased risk of death. Ventricular assist device–related infections and infections occurring in the intermediate interval were associated with the largest increase in risk of death. After left ventricular assist device implantation, infection prevention strategies should target non–ventricular assist device infections in the first 90 days, then shift to surveillance/prevention of driveline infections after 90 days.

Non-patient factors associated with infections in LVAD recipients: A scoping review

Infections are the most common complication in recipients of durable left ventricular assist devices (LVAD) and are associated with increased morbidity, mortality, and expenditures. The existing literature examining factors associated with infection in LVAD recipients is limited and principally comprises single-center studies. This scoping review synthesizes all available evidence related to identifying modifiable, non-patient factors associated with infections among LVAD recipients. Published studies were identified through searching 5 bibliographic databases: PubMed, Scopus, EMBASE, CINAHL, and Web of Science Core Collection. Inclusion criteria required examination of factors associated with infections among recipients of contemporary, implantable, continuous flow LVADs. Key study characteristics were extracted by 4 independent reviewers and current literature described narratively. The Systems Engineering Initiative for Patient Safety (SEIPS) model was used to develop a taxonomy for non-patient related factors (e.g., tasks, tools, technologies, organization, and environment) associated with infections following LVAD implantation. All analyses took place between February 2019 and May 2021. A total of 43 studies met inclusion criteria. The majority of included studies were observational (n=37), single-center (n=29), from the U.S. (n=38), and focused on driveline infections (n=40). Among the 22 evaluated sub-domains of non-patient related factors, only two: increasing center experience and establishing a silicone-skin interface at the driveline exit site, were identified as consistently being associated with a lower risk of infection. This review identified 43 studies that described non-patient related factors associated with infection in LVAD recipients. Only two factors were consistently associated with lower infection risk in LVAD recipients: increasing experience and establishing a silicone-skin interface at driveline exit site. The large variability in reporting across multiple studied interventions limited the ability to discern their effectiveness.

A persistent problem-The dreaded LVAD driveline infection.

A persistent problem-The dreaded LVAD driveline infection.

Third generation continuous flow left ventricular assist devices; a comparative outcome analysis by device type

Abstract Background Continuous-flow left ventricular assist devices (CF-LVADs) have become a standard of care in end-stage heart failure (HF). Device-related complications remain high. Limited data exists comparing outcomes of the HeartMate 3 (HM3) and the HeartWare HVAD (HW). We aimed to analyze HM3 and HW devices implanted over the past 10 years with a focus on long-term clinical outcomes of respective patients. Methods Investigator-initiated comparative, retrospective observational analysis of all patients who underwent primary implantation of a centrifugal CF-LVAD at our tertiary care academic center between January 2010 and December 2020. Data derived from a prospective registry, and included all patients receiving a HM3 or HW device. Primary endpoint was overall (all-cause) mortality and heart transplantation. Secondary endpoints included device-related major adverse cardiac and cerebrovascular events (MACCE), as well right heart failure (RHF), gastrointestinal (GI) bleeding, driveline infections, and surgical re-interventions. Results Out of 106 primary CF-LVAD implantations, 36 (34%) received HM3 and 70 (66%) received HW. Median follow-up time was 1.48 years [interquartile range 0.67, 2.41] and did not differ between devices (p=0.739). HM3 was more often implanted in men (91.7% vs. 72.9%, p=0.024), patients were older (median 61 years [54, 66.5] vs. 52.5 years [43, 60], p&amp;lt;0.001), had a higher body mass index (BMI) (median 26.7 kg/m2 [23.4, 29.0] vs. 24.3 kg/m2 [20.7, 27.4], p=0.013), had more comorbidities and were more likely targeted for destination therapy (DT) (36.1% vs. 14.3%, p=0.010). Death occurred in 33.3% of HM3 patients, compared to 22.9% of HW patients, p=0.247 (probability of survival at 2 years 54.7% vs. 74.1%, p=0.296). After adjustment for confounders, we observed a significant 6-fold risk increase in device malfunctions for HW (hazard ratio (HR) 6.49, 95% CI [1.89, 22.32], p=0.003), but no significant differences between devices in pump thrombosis (p=0.173) or overall survival (p=0.801). Conclusions Comparing long-term outcomes between HeartMate 3 and HeartWare HVAD for LVAD support from a prospective registry, HeartWare HVAD patients had a significantly higher risk of device malfunctions. No significant differences were evident between devices in overall survival, and in respect to most clinical outcomes. Funding Acknowledgement Type of funding sources: None. KM Plot primary and secondary outcomesRisk analysis on all outcomes

Impact of phosphodiesterase-5 inhibitors on right ventricular function and exercise capacity after left ventricular assist-device implantation: the PIVAD study

Abstract Background Long-term therapy with oral phosphodiesterase-5 inhibitors (PDE5I) is frequently implemented after left ventricular assist-device (LVAD) implantation to improve hemodynamics and prevent late-onset right ventricular (RV) failure or to facilitate listing for heart transplantation in individuals with persistent pulmonary hypertension. The safety and efficacy of this appoach has not been prospectively studied. Recent analyses of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) demonstrated improved survival for patients under long-term PDE5I after 48 months but higher incidence of early postoperative RV failure as well as a higher risk for gastrointestinal bleeding. Purpose To evaluate the impact of discontinuation of PDE5I in patients on LVAD support. Methods In this prospective, single-arm, interventional study we enrolled LVAD recipients on oral PDE5I (sildenafil or tadalafil) after at least 1 month post-implant who were clinically stable on optimal medical therapy. The patients underwent physical examination, ECG, 6-minute walking test, cardiopulmonary exercise testing, transthoracic echocardiography, LVAD interrogation, questionnaire based evaluation of quality of life and testing of serum biomarkers at baseline and 4 weeks after discontinuation of oral PDE5I therapy. Results From 10/2019 to 02/2021 thirty patiens were included in the study and completed the follow-up. Mean age was 54 years, 90% were male. Destination therapy was the primary treatment goal in 13% of this cohort while 87% received LVAD as a bridge to transplant. Mean dosis of tadalafil was 24.6 mg, of sildenafil 42.5 mg. At follow-up no significant changes were elicited in echocardiographic markers of RV function, peak oxygen consumption, VE/VCO2 slope, eGFR, N-terminal pro-brain natriuretic peptide (NT-proBNP) concentration, quality of life and average flow and power readings of the device but mild increase in walking distance (Table 1). Two patients were hospitalized for non-cardiac reasons (subtherapeutic INR, driveline infection). No patient was hospitalized for cardiac decompensation. Conclusion Discontinuation of PDE5I was not associated with deterioration of RV function, exercise capacity and quality of life after 4 weeks. The risk/benefit profile of PDE5I in LVAD patients needs to be further investigated in context of randomized controlled trials. Funding Acknowledgement Type of funding sources: None. Table 1

The impact of psychiatric diagnoses on two-year outcomes in patients with ventricular assist devices

Abstract Background A multi-specialty approach is required during patient selection for left ventricular assist device (LVAD) implantation. In addition to a comprehensive medical evaluation, patients undergo an extensive psychiatric work up to ensure their candidacy when pursuing durable support devices. We aim to analyze the impact of psychiatric illnesses on 2-year outcomes after VAD implantation. Methods This study was a single center, retrospective analysis of 263 patients who underwent durable LVAD implantation between 2015 and 2017. All patients were evaluated by a single specialist during their work up for LVAD implantation. Patients who had a pre-existing diagnosis defined by criteria outlined in Diagnostic and Statistical Manual of Mental Disorders (DSM-5) were assigned to the History of Psychiatric Diagnosis group. Statistical analysis was performed using Chi-Square and Student's t-tests, wherein p&amp;lt;0.05 was considered statistically significant. Results Of the 263 patients, 68 patients were found to have a history of psychiatric illness compared to 195 who had no previous diagnosis. Of those with a psychiatric history, 30.8% had Depression, 1.5% had Bipolar disorder, 22.1% had Anxiety, 1.5% had PTSD, and 16.2% had more than one diagnosis. 19.5% of patients with no history went on to be transplanted compared to 22.1% of patients with a psychiatric history (p=0.65). No significant difference was found between length of stay, days to readmission, 30-day survival, and 2-year survival. Patients without a psychiatric history were found to have fewer number of readmissions over 2 years (p&amp;lt;0.01) (See Table). No significant difference was seen in complications including driveline infections, bacteremia, cerebrovascular accidents, pump thromboses, pump hemolysis, or major bleeding events (See Table). Conclusion Psychosocial characteristics play a significant role in determining a patient's candidacy for LVAD implantation. Although patients with a history of psychiatric illness were found to have a greater number of readmissions, this did not correlate to poorer outcomes or increased morbidity and mortality over 2 years. This study highlights the importance of taking a multi-faceted approach when determining patient eligibility for mechanical support devices. Future studies with larger population models should be conducted. Funding Acknowledgement Type of funding sources: None.

Relation of Left Ventricular Assist Device Infections With Cardiac Transplant Outcomes

Left ventricular assist device (LVAD)-specific infections (LSIs) are common in patients on LVAD support awaiting heart transplant (HT), yet their impact on post-HT outcomes is not completely understood. We hypothesized that LSIs would result in vasoplegia and negatively affect post-HT 30-day and 1-year outcomes. LSI was defined as driveline, pump, or pocket infection. The short-term outcome was a composite of acute renal failure, allograft rejection, and mortality at 30 days after HT. The long-term outcome was a composite of allograft rejection and death within 1 year after HT. We performed a retrospective analysis of 111 HT recipients bridged with durable LVAD support at our institution from May 2012 to August 2019. Of these, 63 patients had LSIs, with 94% of the infections being driveline infections. Vasoplegia was more prevalent in the LSI group but not significantly (7 vs 2 persons, p=0.3). There was no difference in the composite end point of acute renal failure, rejection, or death at 30 days (30% vs 25%, p=0.55) or 1-year end point of rejection and death (38% vs 40%, p=0.87) in patients with LSI versus those without LSI. In conclusion, LSIs were common in patients on LVAD who underwent HT in our single-center contemporary cohort. However, LSI was not associated with adverse outcomes at 30 days or at 1 year after HT.