Consolidation Osimertinib Versus Durvalumab Versus Observation After Concurrent Chemoradiation in Unresectable EGFR-Mutant NSCLC: A Multicenter Retrospective Cohort Study.

INTRODUCTION: Durvalumab improves survival when used as consolidation therapy after chemoradiation (CRT) in patients with stage III NSCLC. The optimal consolidation therapy for patients with EGFR-mutant (EGFRmut) stage III NSCLC remains unknown. METHODS: In this multi-institutional, international retrospective analysis across 24 institutions, we evaluated outcomes in patients with stage III EGFRmut NSCLC treated with concurrent CRT followed by consolidation therapy with osimertinib, durvalumab, or observation between 2015 and 2022. Kaplan-Meier method was used to estimate real-world progression-free survival (rwPFS, primary end point) and overall survival (secondary end point). Treatment-related adverse events (trAEs) during consolidation treatment were defined using Common Terminology Criteria for Adverse Events version 5.0. Multivariable Cox regression analysis was used. RESULTS: Of 136 patients with stage III EGFRmut NSCLC treated with definitive concurrent CRT, 56 received consolidation durvalumab, 33 received consolidation osimertinib, and 47 was on observation alone. Baseline characteristics were similar across the three cohorts. With a median follow-up of 46 months for the entire cohort, the median duration of treatment was not reached (NR) for osimertinib (interquartile range: NR-NR) and was 5.5 (interquartile range: 2.4-10.8) months with durvalumab. After adjusting for nodal status, stage III A/B/C, and age, patients treated with consolidation osimertinib had significantly longer 24-month rwPFS compared to those treated with durvalumab or in the observation cohorts (osimertinib: 86%, durvalumab: 30%, observation: 27%, p < 0.001 for both comparisons). There was no difference in rwPFS between the durvalumab and the observation cohorts. No significant difference in overall survival across the three cohorts was detected, likely due to the limited follow-up. Any-grade trAE occurred in 52% (2 [6.1%] grade ≥3) and 48% (10 [18%] grade ≥3) of patients treated with osimertinib and durvalumab, respectively. Of 45 patients who progressed on consolidation durvalumab, 37 (82%) subsequently received EGFR tyrosine kinase inhibitors. Of these, 14 (38%) patients developed trAEs including five patients with pneumonitis (14%; 2 [5.4%] grade ≥3) and five patients with diarrhea (14%; 1 [2.7%] grade ≥3). CONCLUSIONS: This study suggests that among patients with stage III unresectable NSCLC with a sensitizing EGFR mutation, consolidation osimertinib was associated with a significantly longer rwPFS compared to durvalumab or observation. No unanticipated safety signals were observed with consolidation osimertinib.

Thrombotic Complications in Immune Thrombocytopenia Patients Treated with Avatrombopag.

Avatrombopag is a novel oral non-peptide thrombopoietin receptor agonist (TPO-RA) that was approved by the FDA as a second-line therapy for chronic immune thrombocytopenia (cITP). Avatrombopag has shown promising results in regards to efficacy and tolerability, but to our knowledge, there are no reports of thrombotic complications associated with avatrombopag. We present two patients with chronic ITP who suffered thromboembolic events shortly after starting treatment with avatrombopag. The first case is that of a 30-year-old female with refractory cITP who failed multiple lines of ITP therapy and was hospitalized with an intracranial bleed. The patient eventually recovered after an emergent splenectomy but subsequently developed a right lower lobe pulmonary embolism three weeks after starting treatment with avatrombopag. The second case is that of a 58-year-old female with a prolonged history of ITP, and no prior history of peripheral vascular disease, who suffered from both arterial and venous thrombotic events four weeks after starting avatrombopag. Given the new arterial and venous thrombotic complications, avatrombopag was stopped. She was challenged with avatrombopag again and developed yet another thrombotic complication.

Extranodal Natural Killer/T-Cell Lymphomas: Current Approaches and Future Directions.

Extranodal natural killer/T(NK/T)-cell lymphoma (ENKTL) is a rare subtype of non-Hodgkin lymphoma that typically presents with an isolated nasal mass, but a sizeable minority present with advanced stage disease and have a significantly poorer prognosis. Those with limited disease are standardly treated with chemotherapy and radiation while those with advanced stage disease are treated with L-asparaginase containing chemotherapy regimens. The addition of modern radiation therapy techniques and the incorporation of L-asparaginase into chemotherapy regimens have significantly improved outcomes in this disease, but relapses and death from relapsed disease remain frequent. Given the high rate of relapse, several novel therapies have been evaluated for the treatment of this disease. In this review, we explore the current standard of care for ENKTL as well as novel therapies that have been evaluated for its treatment and the biologic understanding behind these therapies.

Acute Kidney Injury Secondary to Rhabdomyolysis and COVID-19: A Case Report and Literature Review.

The viral infection causing COVID-19 most notably affects the respiratory system but can result in extrapulmonary clinical manifestations as well. Rhabdomyolysis-associated acute kidney injury (AKI) in the setting of COVID-19 is an uncommon complication of the infection. There is significant interest in this viral infection given its global spread, ease of transmission, and varied clinical manifestations and outcomes. This case report and literature review describes the symptoms, laboratory findings, and clinical course of a patient who developed AKI secondary to rhabdomyolysis and COVID-19, which will help clinicians recognize and treat this condition.

Hereditary Apolipoprotein A-I-Associated Cardiac Amyloidosis: Importance of Endomyocardial Biopsy When Suspicion Remains High.

Cardiac amyloidosis has recently garnered substantial attention. Although the advent of noninvasive diagnostic algorithms revolutionized diagnosis, endomyocardial biopsy may still be considered in select cases to determine the amyloidosis subtype definitively. We report a case of a patients with a known mutation causing hereditary apolipoprotein A-I-associated cardiac amyloidosis. (Level of Difficulty: Advanced.).

Racial disparities in immune-related adverse events of immune checkpoint inhibitors and association with survival based on clinical and biochemical responses.

BACKGROUND: Immune checkpoint inhibitors (ICPi) cause various immune-related adverse events (irAE) with thyroid dysfunction as a commonly reported abnormality. There is increasing evidence showing positive association with development of irAE and survival. However, prior trials with ICPi had underrepresentation of minorities with < 5% African Americans. AIM: To evaluate the association between development of irAE and survival outcomes among a racially diverse patient population. METHODS: Data on patients with stage IV solid malignancies treated with programmed cell death-protein 1/programmed death ligand 1 blockers between January 2013 and December 2018 across MedStar Georgetown Cancer Institute facilities were retrospectively reviewed. Patients treated with cytotoxic T-lymphocyte-associated protein 4 inhibitors were excluded. Progression free survival (PFS) and overall survival (OS) were primary endpoints and were calculated using Kaplan-Meier methods and Wilcoxon rank sum test for comparison. RESULTS: Out of 293 patients who met eligibility criteria, 91 pts (31%) had any grade irAE; most common AE were endocrine (40.7%) specifically TSH elevation, dermatological (23.1%) and rheumatologic (18.7%). Proportion of irAE was significantly higher in Caucasians vs African Americans (60.4% vs 30.8%), in patients with low programmed death ligand 1, lower LDH, older age, and those who had more treatment cycles with ICPi. Rate of progression was lower in patients with irAE (30.8% vs 46.0%, P = 0.0140). Median PFS (5.8 vs 3.0 mo, P = 0.0204) and OS (17.1 vs 7.2 mo, P < 0.0001) were higher with irAE. Statistically significant difference in OS (17.1 vs 8.6 mo, P = 0.0002) but not in PFS (5.8 vs 3.3 mo, P = 0.0545) was noted with endocrine irAE. No differences in survival were observed among other commonly reported irAE. Differences in survival among subgroups of patients with irAE are described. CONCLUSION: Development of irAE positively correlated with improved PFS and OS as reported in previous studies. To our knowledge, this is the first study observing differences in OS favoring endocrine AE and Caucasian race. These factors may be potential surrogate markers of prognosis pending replication of these results in large-scale studies.

Immunotherapy in lung cancer.

Immunotherapy has emerged as an important treatment modality throughout oncology with a particularly important role in the treatment of lung cancer. Early signals showed responses could be achieved in nonsmall cell lung cancer and small cell lung cancer and these monoclonal antibodies have become standards of care for advanced stage disease. They have also shown promise in earlier-stage disease as complements to radiation or surgery, offering the potential for durable, meaningful survival gains.

Continuous infusion factor replacement in haemophilia B during and after cardiac surgery: the better choice?

A 57-year-old man with mild haemophilia B was admitted for coronary artery bypass graft surgery. His factor IX (FIX) activity was 15% on admission. Our goal was to maintain his FIX activity at 80%-100% for post-op days (PODs) 0-3, and at 60%-80% for PODs 4-14. Preoperatively, the patient was given recombinant FIX (rFIX) bolus using the formula:Dosage needed=%(desired FIX level-current level of FIX)×weight (kg)×1.3.This increased his activity to 100%. One IU of rFIX increased FIX activity by 0.8%; the half-life of rFIX is 18-24 hours. The rFIX infusion was started intraoperatively and continued after surgery to maintain target FIX activity. He was discharged on POD 9 on rFIX bolus dosing of 5000 IU every 12 hours for an additional 5 days. Using continuous factor infusion, we managed to decrease the amount rFIX used by >60% while maintaining steady state FIX activity level.

Drugs in development for small cell lung cancer.

Small cell lung cancer (SCLC) is a particularly lethal subtype of lung cancer whose treatment landscape has been relatively devoid of advance. The recent integration of immunotherapy in the first-line treatment of SCLC has improved overall survival (OS), prompting the first major paradigm shift for this disease in decades. Despite this improvement in outcomes, most patients with SCLC will relapse after initial response. Standard salvage systemic therapy for SCLC remains disappointing, with few approved agents and consistently poor outcomes. The need for novel agents to combat this disease remains pressing. Fortunately, there are several agents in various stages of development that hold potential as novel treatments for advanced SCLC. Lurbinectedin, which targets active transcription, has shown activity in platinum-sensitive and platinum-resistant SCLC as monotherapy and in combination with doxorubicin. Aurora A kinase (AAK) inhibitors showed initial activity when given with paclitaxel but in randomized studies, failed to improve outcomes over paclitaxel plus placebo. However, in the subset of patients with MYC expression, targeting AAK was effective. Similarly, agents targeting poly-ADP ribose (PARP) pair well with other DNA damaging drugs but in the subset of patients whose tumors express Schlafen-11 (SLFN-11), efficacy appeared greater. CDK 4/6 inhibition is being explored, primarily as a means to protect myeloid cells during cytotoxic chemotherapy in a strategy expected to be uniquely effective in SCLC. Ongoing trials are also studying are novel formulations of established cytotoxic agents. Delta-like protein 3 (DLL3) is an appealing therapeutic target given its selective expression on SCLC cells, but after initial exciting results, the antibody-drug conjugate (ADC) Rovalpituzumab tesirine (Rova-T) did not have a favorable efficacy to toxicity profile in randomized trials. Other agents targeting DLL3 are under study. Targeting angiogenesis has yielded modest improvements in the past but newer agents such as anlotinib are renewing interest. While the current therapeutic landscape beyond chemo-immunotherapy remains the same as it was decades ago, drug development for SCLC is rapidly moving forward and promises to deliver the needed novel agents in the very near future.

Regadenoson Cardiac Stress Test-Induced Takotsubo Cardiomyopathy: A Case Report.

A 79-year-old female presented with acute left-sided chest pain with shortness of breath; she was afebrile and vitally stable. She had a mildly elevated troponin (0.11 ng/mL). Her N terminal pro B-type natriuretic peptide (NT-proBNP) was 7053 pg/mL and electrocardiography (ECG) showed nonspecific ST, T wave changes. Transthoracic echocardiogram (TTE) revealed an ejection fraction (EF) of 65-70%. She was diagnosed with a non-ST elevation myocardial infarction (NSTEMI) and underwent a nuclear stress test, which was negative for ischemia with no left ventricular motion abnormality and an EF of 73%. The patient developed acute respiratory failure following the Lexiscan (Astellas Pharma US, Northbrook, IL) and had to be intubated. A chest X-ray showed pulmonary edema, and transesophageal echocardiography (TEE) revealed a severely reduced EF of 25% with a new anterior wall motion abnormality. Left heart catheterization showed no significant coronary artery disease. Ventriculogram revealed a significantly reduced EF of 30% with apical akinesia. These findings were compatible with myocardial infarction with non-obstructive coronary arteries (MINOCA), likely secondary to regadenoson, which presented like takotsubo cardiomyopathy (TCM). Her condition gradually improved and the follow-up echo revealed baseline EF without symptoms of heart failure. In conclusion, takotsubo cardiomyopathy can be a potential complication from Lexiscan and can present as new-onset heart failure after the stress test.

Immune Checkpoint Inhibitor-induced Fanconi Syndrome.

Immune checkpoint inhibitors (ICI) have been approved by the Food and Drug Administration (FDA) for use in many solid tumors and hematological malignancies. Immune-related adverse events (irAEs) are potential side effects that can arise during or after treatment with ICI therapy. We describe a case of ICI-induced Fanconi syndrome in a 58-year-old man with extensive-stage small-cell lung cancer (ES-SCLC), who had disease progression after initial chemotherapy and radiation. He was started on nivolumab and ipilimumab as second-line treatment. Three weeks into the therapy, he developed abdominal pain with grade 3 transaminitis and required steroids and mycophenolate for presumed autoimmune hepatitis. Subsequently, he presented with worsening abdominal pain and was found to have an enlarging right adrenal mass. Laboratory work-up revealed a white blood cell (WBC) count of 17 K/µL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) 99/210 U/L, direct bilirubin 2.8 mg/dL, blood urea nitrogen (BUN) 43 mg/dL, Cr 2.31 mg/dL (baseline: 1.1 mg/dL), phosphorus 2.3 mg/dL, and glucose 303 mg/dL with metabolic acidosis. There was no evidence of urinary tract obstruction. Urinary findings were notable for glucosuria (>500 mg/dL), fractional excretion of phosphorus and uric acid of 56% (normal range 10%-20%) and 75% (normal range 7%-10%), respectively. He was started on intravenous (IV) bicarbonate and methylprednisolone. Fanconi syndrome with proximal tubular damage secondary to ICI therapy was diagnosed. He was discharged on oral bicarbonate and steroid taper. On follow-up after four weeks, his renal function recovered to baseline.

Chemo-immunotherapy as first-line treatment for small-cell lung cancer.

Small-cell lung cancer (SCLC) is a highly lethal subtype of lung cancer. Despite concerted efforts over the past several decades, there have been limited therapeutic advances. Traditional chemotherapy offers a high response rate and rapid symptomatic improvement, but its benefit is fleeting, and relapse is quick and unforgiving. Immunotherapy has delivered improved outcomes for patients with many cancers and there was compelling rationale for development in SCLC. While initial efforts with cytotoxic T-lymphocyte protein-4 inhibitors failed to improve upon chemotherapy alone, the addition of programmed death ligand-1 (PD-L1) inhibitors to first-line chemotherapy finally provided long-awaited gains in survival. Atezolizumab, when added to carboplatin and etoposide, improved both progression-free survival and overall survival. Durvalumab, when added to platinum plus etoposide, similarly improved OS. Biomarker development has stalled as PD-L1 expression and tumor mutational burden have not been useful predictive biomarkers. However, based on the significant survival improvements, both atezolizumab and durvalumab were approved by the US Food and Drug Administration to be given with first-line chemotherapy, and these regimens represent the new standards of care for SCLC.

Spinal Cord Stimulator Infection: Approach to Diagnosis, Management, and Prevention.

Spinal cord stimulation (SCS) is the most utilized invasive electrical neuromodulation treatment for the management of refractory chronic pain syndromes. Infection is one of the most dreaded complications related to SCS implantation and may prevent patients from receiving adequate pain treatment, adding to the initial cost and disability. Most SCS infections present as generator pocket infection. However, delay in diagnosis may lead to complications such as meningitis, epidural abscess, and/or vertebral osteomyelitis. Early recognition of SCS-related infections and associated complications is based on clinical suspicion, laboratory testing, and appropriate diagnostic imaging. While superficial surgical site infection following SCS implant may be treated with antibiotic therapy alone, deep infection involving implant warrants device removal to achieve cure. Duration of antimicrobial therapy depends on severity of clinical presentation and presence or absence of associated complications. Several preventive strategies can be incorporated in surgical practice to reduce the risk of SCS infection.

Infective endocarditis due to Granulicatella elegans presenting with musculoskeletal symptoms.

A 62-year-old man with essential hypertension and right L4-L5 hemilaminectomy was referred to rheumatology for evaluation of severe arthralgia and myalgia for 12 months. Review of symptoms was significant for night sweats and 20 pounds unintentional weight loss. Physical examination was significant for holosystolic murmur best heard at the cardiac apex of unclear chronicity. Laboratory investigations revealed elevated inflammatory markers, white blood cell count and B-type natriuretic peptide. Transoesophageal echocardiogram showed flail posterior mitral leaflet with severe mitral regurgitation and two vegetations (2.5×1 cm and 1.6×0.3 cm). Abdominal CT showed new focal splenic infarcts, and a brain MRI revealed subacute infarcts, consistent with the embolic phenomenon. Blood cultures grew Granulicatella elegans The patient underwent mitral valve replacement surgery followed by 6 weeks of parenteral therapy with vancomycin and gentamicin, with full recovery at a 3-month follow-up.

Clinical Presentation, Management, and Outcomes of Cardiovascular Implantable Electronic Device Infections Due to Gram-Negative Versus Gram-Positive Bacteria.

OBJECTIVE: To describe and compare the clinical presentation, management, and outcomes of cardiovascular implantable electronic device (CIED) infections due to gram-negative bacteria (GNB) and CIED infections due to gram-positive bacteria (GPB). PATIENTS AND METHODS: We retrospectively reviewed all CIED infection cases at Mayo Clinic from January 1, 1992, through December 31, 2015. Cases were classified based on positive microbiology data from extracted devices or blood cultures. RESULTS: Of the 623 CIED infections during the study period, 31 (5.0%) were caused by GNB and 323 (51.8%) by GPB. Patients in the GNB group were more likely to present with local inflammatory findings at the pocket site (90.3% vs 72.4%; P=.03). All patients with bacteremia due to GNB had concomitant pocket infection compared with those with GPB (100% vs 33.9%; P=.002). After extraction, 41.9% of patients in the GNB group were managed with oral antibiotics vs 2.4% in the GPB group (P<.001). There were no statistically significant differences in infection relapse/recurrence or 1-year survival rates between the 2 groups. CONCLUSION: Compared with CIED infections caused by GPB, those due to GNB are more likely to present with pocket infection. Device-related GNB bacteremia almost always originates from the generator pocket. After extraction, oral antibiotic drug therapy may be a reasonable option in select cases of pocket infections due to GNB. No difference in outcomes was observed between the 2 groups.

Meta-analysis of 18F-FDG PET/CT in the diagnosis of infective endocarditis.

BACKGROUND: The current diagnosis of infective endocarditis (IE) is based on the modified Duke criteria, which has approximately 80% sensitivity for the diagnosis of native valve endocarditis (NVE), with lower sensitivity for the diagnosis of prosthetic valve endocarditis (PVE) and culture-negative endocarditis. There is preliminary evidence that 18F-FDG PET/CT is an adjunctive diagnostic test with high accuracy reported in small studies to date. We therefore performed a meta-analysis of studies evaluating the use of PET/CT in the diagnosis of IE to establish a more precise estimate of accuracy. METHODS: PubMed, Embase, Cochrane library, CINAHL, Web of Knowledge, and www.clinicaltrials.gov were searched from January 1990 to April 2017 for studies evaluating the accuracy of PET/CT for the evaluation of possible IE. RESULTS: We identified 13 studies involving 537 patients that were included in the meta-analysis. The pooled sensitivity of PET/CT for diagnosis of IE was 76.8% (95% CI 71.8-81.4%; Q = 39.9, P < 0.01; I2 = 69.9%) and the pooled specificity was 77.9% (95% CI 71.9-83.2%; Q = 44.42, P < 0.01; I2 = 73.0%). Diagnostic accuracy was improved for PVE with sensitivity of 80.5% (95% CI 74.1-86.0%; Q = 25.5, P < 0.01; I2 = 72.5%) and specificity of 73.1% (95% CI 63.8-81.2%; Q = 32.1, P < 0.01; I2 = 78.2%). Additional extracardiac foci of infection were found on 17% of patients on whole body PET/CT. CONCLUSION: PET/CT is a useful adjunctive diagnostic tool in the evaluation of diagnostically challenging cases of IE, particularly in prosthetic valve endocarditis. It also has the potential to detect clinically relevant extracardiac foci of infection, malignancy, and other sources of inflammation leading to more appropriate treatment regimens and surgical intervention.

Role of 18F-FDG PET/CT in the diagnosis of cardiovascular implantable electronic device infections: A meta-analysis.

OBJECTIVE: We performed a meta-analysis evaluating the use of fluorine-18-fluorodeoxyglucose (18F-FDG) positron-emission tomography (PET)/computed tomography (CT) in the diagnosis of cardiovascular implantable electronic device (CIED) infections. BACKGROUND: PET/CT may be helpful in the diagnosis of CIED infection, particularly in patients with the absence of localizing signs or definitive echocardiographic findings. METHODS: PubMed, Embase, Cochrane library, CINAHL, Web of Knowledge, and www.clinicaltrials.gov from January 1990 to April 2017 were searched for studies evaluating the accuracy of PET/CT in the diagnosis of CIED infections. RESULTS: Overall, 14 studies involving 492 patients were included in the meta-analysis. The pooled sensitivity of PET/CT for diagnosis of CIED infection was 83% (95% CI 78%-86%) and the pooled specificity was 89% (95% CI 84%-94%). PET/CT demonstrated a higher sensitivity of 96% (95% CI 86%-99%) and specificity of 97% (95% CI 86%-99%) for diagnosis of pocket infections. Diagnostic accuracy for lead infections or CIED-IE was lower with pooled sensitivity of 76% (95% CI 65%-85%) and specificity of 83% (95% CI 72%-90%). CONCLUSION: Use of PET/CT in the evaluation of CIED infection has both a high sensitivity (83%) and specificity (89%) and deserves consideration in the management of selected patients with suspected CIED infections.

Unrecognized pre-transplant disseminated Coxiella burnetti infection diagnosed in a post-transplant heart-kidney recipient.

To the best of our knowledge, we report the first case of pre-transplant unrecognized disseminated Coxiella burnetii infection, unmasked in the post-transplant period leading to both heart and kidney allograft dysfunction. A 59 year old man with a history of simultaneous heart-kidney transplantation due to end stage heart failure from severe aortic regurgitation (AR) and cryoglobulinemic immune complex mediated concentric necrotizing glomerulonephritis (GN), presents with a history of intermittent fevers and fatigue. Prior to transplantation he was treated for multiple episodes of culture negative endocarditis requiring bio-prosthetic valve replacement. Evaluation of fever included a transesophageal echocardiogram (TEE) that revealed a large hyperechoic mass on the anterior mitral leaflet with perforation, severe mitral regurgitation and moderate AR. Blood cultures were negative at that time. Owing to development of allograft mitral and aortic valve insufficiency, he underwent allograft bio-prosthetic mitral valve (MV) replacement and aortic valvuloplasty 2 years following his transplantation. Pathologic examination of the allograft mitral valve demonstrated fibrinopurulent exudate with degenerating bacterial organisms, consistent with vegetation and myxoid degenerative changes. Due to a high suspicion for native heart C. burnetii prosthetic valve endocarditis prior to transplantation, we re-evaluated the native explanted heart histopathology, as well as the explanted allograft MV. Cardiac allograft and native MV were positive for C. burnetii by real-time PCR. C. burnetii serology was consistent with persistent infection as well.

Diagnostic evaluation and management of culture-negative cardiovascular implantable electronic device infections.

BACKGROUND: Culture-negative (CN) cardiovascular implantable electronic device (CIED) infections represent a significant management challenge for clinicians with no specific guidelines addressing this subgroup of patients. The aim of the current investigation is to report our institutional experience of CN CIED infections and propose a systematic approach to diagnostic evaluation and management of these complicated cases based on our observations. METHODS: We retrospectively screened all CIED infection cases at Mayo Clinic from 2005 through 2017. Using standardized criteria to define significant microbial growth, all patients with positive blood or pocket/device cultures were excluded. RESULTS: A total of 835 cases of CIED infection were screened, and of these, 47 (6%) met CN-CIED infection criteria. Majority of patients (77%) in this cohort had received antimicrobial therapy prior to device cultures with a median duration of 8 days. The most common presentation was device pocket infection (81%). All patients underwent device removal. Route of antibiotics was switched from oral to parenteral and spectrum of activity expanded from initial therapy in 23% of patients despite negative cultures. Majority of patients (80%) were dismissed on parenteral therapy. Adverse events attributed to intravenous antibiotic therapy were documented in 63% of the cases. No recurrence was reported and 6-month survival was 94.8%. CONCLUSIONS: Pocket and device cultures in suspected CIED infections may be negative due to preextraction oral antibiotics. However, frequently these patients are managed with broad-spectrum parenteral therapy postextraction.