A Modular Communicative Leadless Pacing-Defibrillator System.

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (ICD) is associated with fewer lead-related complications than a transvenous ICD; however, the subcutaneous ICD cannot provide bradycardia and antitachycardia pacing. Whether a modular pacing-defibrillator system comprising a leadless pacemaker in wireless communication with a subcutaneous ICD to provide antitachycardia and bradycardia pacing is safe remains unknown. METHODS: We conducted a multinational, single-group study that enrolled patients at risk for sudden death from ventricular arrhythmias and followed them for 6 months after implantation of a modular pacemaker-defibrillator system. The safety end point was freedom from leadless pacemaker-related major complications, evaluated against a performance goal of 86%. The two primary performance end points were successful communication between the pacemaker and the ICD (performance goal, 88%) and a pacing threshold of up to 2.0 V at a 0.4-msec pulse width (performance goal, 80%). RESULTS: We enrolled 293 patients, 162 of whom were in the 6-month end-point cohort and 151 of whom completed the 6-month follow-up period. The mean age of the patients was 60 years, 16.7% were women, and the mean (±SD) left ventricular ejection fraction was 33.1±12.6%. The percentage of patients who were free from leadless pacemaker-related major complications was 97.5%, which exceeded the prespecified performance goal. Wireless-device communication was successful in 98.8% of communication tests, which exceeded the prespecified goal. Of 151 patients, 147 (97.4%) had pacing thresholds of 2.0 V or less, which exceeded the prespecified goal. The percentage of episodes of arrhythmia that were successfully terminated by antitachycardia pacing was 61.3%, and there were no episodes for which antitachycardia pacing was not delivered owing to communication failure. Of 162 patients, 8 died (4.9%); none of the deaths were deemed to be related to arrhythmias or the implantation procedure. CONCLUSIONS: The leadless pacemaker in wireless communication with a subcutaneous ICD exceeded performance goals for freedom from major complications related to the leadless pacemaker, for communication between the leadless pacemaker and subcutaneous ICD, and for the percentage of patients with a pacing threshold up to 2.0 V at a 0.4-msec pulse width at 6 months. (Funded by Boston Scientific; MODULAR ATP ClinicalTrials.gov NCT04798768.).

Comparative Effectiveness of Left Atrial Appendage Occlusion Versus Oral Anticoagulation by Sex.

BACKGROUND: The comparative real-world outcomes of older patients with atrial fibrillation (AF) treated with anticoagulation compared with left atrial appendage occlusion (LAAO) may be different from those in clinical trials because of differences in anticoagulation strategies and patient demographics, including a greater proportion of women. We sought to compare real-world outcomes between older patients with AF treated with anticoagulation and those treated with LAAO by sex. METHODS: Using Medicare claims data from 2015 to 2019, we identified LAAO-eligible beneficiaries and divided them into sex subgroups. Patients receiving LAAO were matched 1:1 to those receiving anticoagulation alone through propensity score matching. The risks of mortality, stroke or systemic embolism, and bleeding were compared between matched groups with adjustment for potential confounding characteristics in Cox proportional hazards models. RESULTS: Among women, 4085 LAAO recipients were matched 1:1 to those receiving anticoagulation; among men, 5378 LAAO recipients were similarly matched. LAAO was associated with a significant reduction in the risk of mortality for women and men (hazard ratio [HR], 0.509 [95% CI, 0.447-0.580]; and HR, 0.541 [95% CI, 0.487-0.601], respectively; P<0.0001), with a similar finding for stroke or systemic embolism (HR, 0.655 [95% CI, 0.555-0.772]; and HR, 0.649 [95% CI, 0.552-0.762], respectively; P<0.0001). Bleeding risk was significantly greater in LAAO recipients early after implantation but lower after the 6-week periprocedural period for women and men (HR, 0.772 [95% CI, 0.676-0.882]; and HR, 0.881 [95% CI, 0.784-0.989], respectively; P<0.05). CONCLUSIONS: In a real-world population of older Medicare beneficiaries with AF, compared with anticoagulation, LAAO was associated with a reduction in the risk of death, stroke, and long-term bleeding among women and men. These findings should be incorporated into shared decision-making with patients considering strategies for reduction in AF-related stroke.

One-year outcomes of pulmonary vein isolation with a novel cryoballoon: Primary results of the FROZEN AF trial.

INTRODUCTION: Cryoablation therapy for pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF) is well established. A novel 28 mm cryoballoon system designed to operate under low pressure to safely reach a lower nadir temperature and maintain constant balloon size during cooling has not been prospectively studied in a large patient population for safety and efficacy. The FROZEN AF (NCT04133168) trial was an international multicenter, open-label, prospective, single-arm study on the safety and performance of a novel cryoballoon system for treatment of PAF. METHODS AND RESULTS: The study enrolled patients at 44 sites in 10 countries across North America, Europe, and Asia. Subjects were indicated for PVI treatment of PAF and had failed or were intolerant of one or more antiarrhythmic drugs. Procedural outcomes were defined based on the 2017 HRS consensus statement. Follow-up was performed at 7 days, 3, 6, and 12 months. Data are reported as mean ± SD or median (IQR). PVI was performed with a 28 mm cryoballoon in 325 drug refractory PAF patients. Complete PVI was achieved in 95.7% of patients. In cryoablation lesions longer than 60 s, 60.1% of PV isolations required only a single cryoballoon application. Procedure related complications included: phrenic nerve palsy [temporary 4 (1.2%), persistent 0 (0.0%)], cardiac tamponade/perforation 2 (0.6%), and air embolism 1 (0.3%). Freedom from documented atrial arrhythmia recurrence at 12 months was 79.9% (AF 82.7%, AFL 96.5%, AT 98.1%), antiarrhythmic drugs (AAD) were continued or re-initiated in 26.8% of patients after the 3-month blanking period. Additionally, an extension arm enrolled 50 pts for treatment with 28/31 mm variable size cryoballoon. A single temporary PNP occurred in this group, which resolved before discharge. Freedom from documented recurrence at 12 months in these pts was 82.0%. CONCLUSIONS: This novel cryoballoon may facilitate PVI to treat PAF, providing more options to address the variety of anatomies present in patients with PAF. This cryoballoon system proved to be safe and effective for treatment of patients with drug refractory or drug intolerant PAF.

Result of the left bundle branch area pacing data collection registry, an international multicenter study of conduction system pacing with a Tendril STS 2088 stylet-driven lead.

INTRODUCTION: Left bundle branch area (LBBA) pacing (LBBAP) has been proposed as an alternative therapy option in patients indicated for cardiac pacing to treat bradycardia or heart failure. The aim of the study was to evaluate the safety and effectiveness of LBBAP in patients implanted with a Tendril 2088 stylet-driven lead. METHODS: The international retrospective data collection registry included 11 sites from 5 countries globally. Patients with attempted implants of the Tendril lead in the LBBA were followed for at least 6 months post the implant attempt. The primary safety and efficacy endpoints were freedom from LBBAP lead-related serious adverse events and the composite of LBBA capture threshold of ≤2.0 V and R-wave amplitudes ≥5 mV (or ≥value at implant), respectively. RESULTS: Of 221 patients with attempted implants of the Tendril 2088 lead in the LBBA, 91.4% (202/221) had successful implants for LBBAP. Regardless of the LBBAP implant success, all patients were followed for at least 6 months (8.7 ± 7.3 months). Baseline characteristics: 44% female, 84% ≥65 years old, 34% coronary artery disease, and 86% of primary indications for pacemaker implant. Both primary safety and effectiveness endpoints were met (freedom from LBBAP lead-related serious adverse device effects of 99.5% and electrical performance composite success rate of 93%). The capture thresholds in LBBAP at implant and 6 months were 0.8 ± 0.3 V@0.4 ± 0.1 ms and 0.8 ± 0.3 V@0.4 ± 0.1 ms. The rate of patients with capture threshold rise ≥1 V was 1.5% through 6 months. The R-wave amplitudes in LBBAP at implant and 6 months were 9.3 ± 3.2 mV and 10.6 ± 3.0 mV. CONCLUSIONS: This large multicenter study demonstrates that the stylet-driven Tendril™ STS 2088 lead is safe and effective for LBBAP with high success and low complication rates.

Rationale and design of a randomized study comparing the Watchman FLX device to DOACs in patients with atrial fibrillation.

BACKGROUND: Percutaneous left atrial appendage (LAA) closure (LAAC) was developed as a nonpharmacologic alternative to oral anticoagulants (OACs) in patients with atrial fibrillation (AF) who are at an increased risk for stroke or systemic embolism. The Watchman device permanently seals off the LAA to prevent thrombi from escaping into the circulation. Previous randomized trials have established the safety and efficacy of LAAC compared to warfarin. However, direct OACs (DOACs) have become the preferred pharmacologic strategy for stroke prevention in patients with AF, and there is limited data comparing Watchman FLX to DOACs in a broad AF patient population. CHAMPION-AF is designed to prospectively determine whether LAAC with Watchman FLX is a reasonable first-line alternative to DOACs in patients with AF who are indicated for OAC therapy. STUDY DESIGN: A total of 3,000 patients with a CHA2DS2-VASc score ≥2 (men) or ≥3 (women) were randomized to Watchman FLX or DOAC in a 1:1 allocation at 142 global clinical sites. Patients in the device arm were to be treated with DOAC and aspirin, DOAC alone, or DAPT for at least 3 months postimplant followed by aspirin or P2Y12 inhibitor for 1-year. Control patients were required to take an approved DOAC for the duration of the trial. Clinical follow-up visits are scheduled at 3- and 12-months, and then annually through 5 years; LAA imaging is required at 4 months in the device group. Two primary end points will be evaluated at 3 years: (1) composite of stroke (ischemic/hemorrhagic), cardiovascular death, and systemic embolism compared for noninferiority, and (2) nonprocedural bleeding (International Society on Thrombosis and Haemostasis [ISTH] major and clinically relevant nonmajor bleeding) tested for superiority in the device arm against DOACs. The third primary noninferiority end point is the composite of ischemic stroke and systemic embolism at 5 years. Secondary end points include 3- and 5-year rates of (1) ISTH-defined major bleeding and (2) the composite of cardiovascular death, all stroke, systemic embolism, and nonprocedural ISTH bleeding. CONCLUSIONS: This study will prospectively evaluate whether LAAC with the Watchman FLX device is a reasonable alternative to DOACs in patients with AF. CLINICAL TRIAL REGISTRATION: NCT04394546.

Contact force catheter ablation for the treatment of persistent atrial fibrillation: Results from the PERSIST-END study.

INTRODUCTION: Use of a novel magnetic sensor enabled optical contact force ablation catheter has been established to be safe and effective for treatment of symptomatic drug-refractory paroxysmal atrial fibrillation (AF) but has yet to be demonstrated in the persistent AF (PersAF) population. METHODS: PERSIST-END was a multicenter, prospective, nonrandomized, investigational study designed to demonstrate the safety and effectiveness of TactiCath™ Ablation Catheter, Sensor Enabled™(SE) (TactiCath SE) for use in the treatment of subjects with documented PersAF refractory or intolerant to at least one Class I/III AAD. The ablation strategy included pulmonary vein isolation and additional targets at physician discretion. Follow-up through 15-months, including a 3-month blanking period and 3-month therapy consolidation period, was performed with cardiac event and Holter monitoring. Primary safety, primary effectiveness, clinical success, and quality of life (QOL) endpoints were analyzed. RESULTS: Of 224 subjects enrolled at 21 investigational sites in the United States and Australia, 223 underwent ablation with the investigational catheter. The primary safety event rate was 3.1% (seven events in seven subjects). The Kaplan-Meier estimate of freedom from AF/atrial flutter/atrial tachycardia recurrence at 15-months was 61.6% and clinical success at 15 months was 89.8%. Subject QOL significantly improved following ablation as assessed via AFEQT (31.6 point increase, p < .0001) and EQ-5D-5L (10.7 point increase, p < .0001) and was met with a 53% reduction in all cause cardiovascular healthcare utilization. CONCLUSION: The sensor-enabled force-sensing catheter is safe and effective for the treatment of drug refractory recurrent symptomatic PersAF, reducing arrhythmia recurrence while improving QOL and healthcare utilization.

Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial.

BACKGROUND: Left atrial appendage (LAA) occlusion provides an alternative to oral anticoagulation for thromboembolic risk reduction in patients with nonvalvular atrial fibrillation. Since regulatory approval in 2015, the WATCHMAN device has been the only LAA closure device available for clinical use in the United States. The PINNACLE FLX study (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the Watchman FLX LAA Closure Technology) evaluated the safety and effectiveness of the next-generation WATCHMAN FLX LAA closure device in patients with nonvalvular atrial fibrillation in whom oral anticoagulation is indicated, but who have an appropriate rationale to seek a nonpharmaceutical alternative. METHODS: This was a prospective, nonrandomized, multicenter US Food and Drug Administration study. The primary safety end point was the occurrence of one of the following events within 7 days after the procedure or by hospital discharge, whichever was later: death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring cardiac surgery. The primary effectiveness end point was the incidence of effective LAA closure (peri-device flow ≤5 mm), as assessed by the echocardiography core laboratory at 12-month follow-up. RESULTS: A total of 400 patients were enrolled. The mean age was 73.8±8.6 years and the mean CHA2DS2-VASc score was 4.2±1.5. The incidence of the primary safety end point was 0.5% with a 1-sided 95% upper CI of 1.6%, meeting the performance goal of 4.2% (P<0.0001). The incidence of the primary effectiveness end point was 100%, with a 1-sided 95% lower CI of 99.1%, again meeting the performance goal of 97.0% (P<0.0001). Device-related thrombus was reported in 7 patients, no patients experienced pericardial effusion requiring open cardiac surgery, and there were no device embolizations. CONCLUSIONS: LAA closure with this next-generation LAA closure device was associated with a low incidence of adverse events and a high incidence of anatomic closure. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02702271.

Ambulatory Monitoring of Heart Sounds via an Implanted Device Is Superior to Auscultation for Prediction of Heart Failure Events.

BACKGROUND: We compared the relationship between the third heart sound (S3) measured by an implantable cardiac device (devS3) and auscultation (ausS3) and evaluated their prognostic powers for predicting heart failure events (HFEs). METHODS AND RESULTS: In the MultiSENSE study, devS3 was measured daily with continuous values, whereas ausS3 was assessed at study visits with discrete grades. They were compared among patients with and without HFEs at baseline and against each other directly. Cox proportional hazard models were developed between follow-up visits and over the whole study. Simulations were performed on devS3 to match the limitations of auscultation. We studied 900 patients, of whom 106 patients experienced 192 HFEs. Two S3 sensing modalities correlated with each other, but at baseline, only devS3 differentiated patients with or without HFEs (P < 0.0001). The prognostic power of devS3 was superior to that of ausS3 both between follow-up visits (HR = 5.7, P < 0.0001, and 1.7, P = 0.047, respectively) and over the whole study (HR = 2.9, P < 0.0001, and 1.4, P = 0.216, respectively). Simulation results suggested this superiority may be attributed to continuous monitoring and to subaudible measuring capability. CONCLUSIONS: S3 measured by implantable cardiac devices has stronger prognostic power to predict episodes of future HFEs than that of auscultation.

Performance of Anatomically Designed Quadripolar Left Ventricular Leads: Results from the NAVIGATE X4 Clinical Trial.

INTRODUCTION: The safety and efficacy of a novel family of quadripolar left ventricular (LV) pacing leads designed to pace from nonapical regions of the LV with low pacing capture thresholds was studied in patients undergoing implantation of a cardiac resynchronization therapy defibrillator (CRT-D). METHODS AND RESULTS: Patients receiving a CRT-D were implanted with 1 of 3 ACUITY X4 leads (Spiral Long, Spiral Short, or Straight), designed to address coronary venous anatomical variability. Electrical performance and LV lead related complications were evaluated 3 and 6 months post implantation, respectively. 764 patients (68 ± 11 years, 66% male) were enrolled; 738 (97%) successfully implanted with an ACUITY X4 lead (Spiral L, n = 239, 31%; Spiral S, n = 281, 37%; Straight, n = 218, 29%). A targeted threshold ≤2.5 V was achieved in 644 (94%) patients. The median threshold from the best proximal electrode was lower than the tip electrode (0.9 V [IQR 0.7, 1.3] vs. 1.3 V [IQR 0.7, 2.5], p< 0.001) on Spiral leads. Irrespective of lead implanted, one of the proximal electrodes was the programmed cathode in most patients. The overall LV complication-free rate was 98%. LV lead dislodgment occurred in 8 (1%) patients. PNS occurred in 58 (8%) patients, but only 3 (0.4%) patients required surgical intervention. CONCLUSION: The ACUITY X4 LV leads had low pacing thresholds particularly from proximal electrodes, a high incidence of pacing from the nondistal electrode, and low likelihood of dislodgment or PNS requiring surgical intervention. (ClinicalTrials.gov Identifier: NCT02071173).

EVALUATION OF MAGNETIC RESONANCE IMAGING GUIDELINES FOR DIFFERENTIATION BETWEEN THORACOLUMBAR INTERVERTEBRAL DISK EXTRUSIONS AND INTERVERTEBRAL DISK PROTRUSIONS IN DOGS.

Four MRI variables have recently been suggested to be independently associated with a diagnosis of thoracolumbar intervertebral disk extrusion or protrusion. Midline intervertebral disk herniation, and partial intervertebral disk degeneration were associated with intervertebral disk protrusion, while presence of a single intervertebral disk herniation and disk material dispersed beyond the boundaries of the intervertebral disk space were associated with intervertebral disk extrusion. The aim of this retrospective, cross-sectional study was to determine whether using these MRI variables improves differentiation between thoracolumbar intervertebral disk extrusions and protrusions. Eighty large breed dogs with surgically confirmed thoracolumbar intervertebral disk extrusions or protrusions were included. Randomized MRI studies were presented on two occasions to six blinded observers, which were divided into three experience categories. During the first assessment, observers made a presumptive diagnosis of thoracolumbar intervertebral disk extrusion or protrusion without guidelines. During the second assessment they were asked to make a presumptive diagnosis with the aid of guidelines. Agreement was evaluated by Kappa-statistics. Diagnostic accuracy significantly improved from 70.8 to 79.6% and interobserver agreement for making a diagnosis of intervertebral disk extrusion or intervertebral disk protrusion improved from fair (κ = 0.27) to moderate (κ = 0.41) after using the proposed guidelines. Diagnostic accuracy was significantly influenced by degree of observer experience. Intraobserver agreement for the assessed variables ranged from fair to excellent and interobserver agreement ranged from fair to moderate. The results of this study suggest that the proposed imaging guidelines can aid in differentiating thoracolumbar intervertebral disk extrusions from protrusions.

Consumer satisfaction, palliative care and artificial intelligence (AI).

The scope of artificial intelligence (AI) in healthcare is promising, and AI has the potential to revolutionise the field of palliative care services also. Consumer satisfaction in palliative care is a critical aspect of providing high-quality end-of-life support. It encompasses various elements that contribute to a positive experience for both patients and their families. AI-based tools and technologies can help in early identification of the beneficiaries, reduce the cost, improve the quality of care and satisfaction to the patients with chronic life-limiting illnesses. However, it is essential to ensure that AI is used ethically and in a way that complements, rather than replaces, the human touch and compassionate care, which are the core components of palliative care. This article tries to analyse the scope and challenges of improving consumer satisfaction through AI-based technology in palliative care services.

Micra Extraction Out To 4.5 Years.

Leadless pacemaker systems (LPs) were developed as an alternative to traditional transvenous permanent pacemakers (TV-PPM) due to increasing rates of device and procedural related complications, leading to a high-cost burden to our health-care system. LPs were initially indicated for single-chamber ventricular pacing; however, recent developments have allowed for dual-chamber pacing too. These systems have demonstrated highly successful implant rates with stable pacing performance. This article describes the retrieval techniques of the Micra LPs and ways to mitigate challenges encountered during the retrieval process.

Myocarditis: A Rare Complication of Immune Checkpoint Inhibitor Therapy.

Immune checkpoint inhibitors (ICIs) are a class of immunotherapy agents that are often used in cancer treatment. A rare but life-threatening complication that can be seen is ICI-induced myocarditis. We discuss a case of pembrolizumab-induced myocarditis and the nuances involved in timely diagnosis and treatment. A 64-year-old female with a past medical history significant for metastatic right-sided colorectal adenocarcinoma undergoing immunotherapy with pembrolizumab presented with worsening shortness of breath and was found to be hypoxic. Initial laboratory analysis was remarkable for troponin of 0.35 ng/mL, which later peaked at 6.01 ng/mL. The electrocardiogram showed non-specific ST segment changes in the anteroseptal leads, and a subsequent echocardiogram revealed severely reduced left ventricular systolic function with an ejection fraction of 25%. Coronary angiography showed non-obstructive coronary arteries. As the patient was on pembrolizumab immunotherapy for cancer, there was high suspicion of ICI-induced myocarditis, and the patient was started empirically on steroids. Subsequently, cardiac magnetic resonance imaging was done, which confirmed the diagnosis of myocarditis. Pembrolizumab therapy was discontinued, and she was started on guideline-directed medical therapy for heart failure. While ICIs have transformed cancer therapy, healthcare providers must be vigilant for immune-related adverse events such as myocarditis. Early recognition, prompt management, and close monitoring are crucial for optimizing patient outcomes.

"Hot and Achy": A Case of an Extensive Spinal Epidural Abscess.

We present a case of a 94-year-old female who presented to the emergency room with a fever and generalized weakness without an initial obvious source of infection. Throughout admission, she continued to be febrile despite broad-spectrum antibiotics. Several days into admission, the patient complained of severe back pain, necessitating magnetic resonance imaging (MRI) of the entire spine. The imaging revealed an extensive epidural fluid collection consistent with a spinal epidural abscess. Fortunately, she did not have any neurological deficits and was treated conservatively with IV antibiotics with improvement. This case highlights this rare presentation and the importance of early diagnosis and management of spinal epidural abscesses.

Anomalous Bronchial Artery Origin - Canary in the Coal Mine - For Diagnosing Chronic Thromboembolic Pulmonary Hypertension.

Anomalous bronchial artery origins may have clinical implications beyond their anatomical curiosity. In this case, identification of such an anomaly led to the diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH). A 49-year-old male with a history of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE) on anticoagulation presented with chest pain and shortness of breath. Laboratory analysis was remarkable for a troponin peak of 14.74 ng/ml, a brain natriuretic peptide level of 602 pg/ml and a D-dimer level of 0.62 µg/ml. Electrocardiogram showed non-specific ST elevation in the anterolateral and inferior leads. Computed tomography angiography (CTA) of the chest was positive for PE involving the right lower lobe pulmonary arterial tree. Echocardiogram showed reduced left ventricular function (ejection fraction 38%) and akinesis of the antero-apical and infero-apical segments. Cardiac catheterization revealed non-obstructive coronary arteries, and an anomalous origin of a right bronchial artery from the right coronary artery. The right bronchial hypertrophied as it supplied collateral flow to the occluded right pulmonary artery. This anomaly and the patient's history of multiple DVT/PEs while on therapeutic levels of warfarin with near normal D-dimer levels raised suspicion for a false positive PE. Pulmonary angiogram revealed chronic occlusion in branches of the right pulmonary artery, mean pulmonary artery pressure of 36 mmHg and no acute thrombus. Ventilation-perfusion scan confirmed the diagnosis of CTEPH. The patient underwent successful pulmonary thromboendarterectomy and subsequently had normalization of mean pulmonary artery pressure. This case underscores the importance of a comprehensive diagnostic approach, and consideration of alternative explanations for imaging findings, that unveiled the diagnosis of a complex and life-threatening condition such as CTEPH. LEARNING POINTS: This case underscores the diagnostic significance of identifying anomalous bronchial artery origin which played a crucial role in the diagnosis of the underlying chronic thromboembolic pulmonary hypertension (CTEPH).It is important to understand the limitations of computed tomography angiography (CTA) chest for diagnosis of CTEPH.

Unveiling Ureaplasma: A Case Report of a Rare Culprit in Pyelonephritis.

Ureaplasma species, typically considered commensal organisms of the human urogenital tract, have been implicated in various urinary tract infections (UTIs), including the rare and challenging presentation of pyelonephritis. This case report describes a unique instance of pyelonephritis induced by Ureaplasma, characterized by a negative routine urine culture and a lack of response to empirical antibiotic treatment, highlighting the complexities associated with diagnosing and managing infections caused by atypical pathogens. A 50-year-old female presented to the emergency department with symptoms suggestive of UTI, including fever, vomiting, and dysuria. However, initial urine analysis was notable for pyuria while routine bacterial culture returned negative results, creating a diagnostic dilemma. Empirical treatment with third-generation cephalosporin was initiated. However, the patient's condition failed to improve, raising concerns about antibiotic resistance or atypical pathogens. Subsequent molecular diagnostics, precisely polymerase chain reaction (PCR), identified Ureaplasma urealyticum as the causative agent. This prompted a change in the treatment regimen to doxycycline, to which the patient showed significant clinical improvement. Physicians should be aware of Ureaplasma as a potential cause of pyelonephritis, especially in cases of culture-negative UTIs and when patients do not respond to standard empirical treatment. This case emphasizes the importance of considering atypical pathogens in differential diagnosis and the role of molecular diagnostic techniques in guiding appropriate management.

A Case of Omeprazole-Associated Acute Interstitial Nephritis.

Acute interstitial nephritis (AIN) is characterized by an inflammatory infiltrate of the interstitium of the kidney, typically causing a decline in kidney function. Drug-induced AIN (also called allergic AIN) is a type of AIN. Common drugs associated with AIN are antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), and proton pump inhibitors (PPIs). A 59-year-old male with a history of recent laparoscopic robotic sleeve gastrectomy presented to the emergency department with five weeks of progressively worsening fatigue, nausea, and lightheadedness. Postoperatively, he was prescribed omeprazole 20 mg daily for gastric ulcer prophylaxis. His other home medications were amlodipine, atorvastatin, ursodiol, and budesonide-formoterol fumarate nebulizer. His physical examination was normal. Laboratory studies revealed elevated creatinine of 4.19 mg/dL from a baseline of 0.9 mg/dL two months ago and the presence of urine eosinophils. The etiology of this elevated creatinine was unclear, prompting CT-guided left renal biopsy. The biopsy showed diffuse interstitial inflammatory infiltration with numerous lymphocytes, a large number of neutrophils, and scattered eosinophils, consistent with the allergic type of AIN. Omeprazole was discontinued and the patient received a seven-day course of prednisone. Despite treatment, permanent renal damage occurred, and the patient's new baseline creatinine was 2.3 mg/dL. AIN caused by PPIs should be considered in the differential diagnosis of acute kidney injury (AKI). AIN can be difficult to diagnose, presenting with nonspecific symptoms, such as oliguria, malaise, nausea, and vomiting. An accurate and timely diagnosis can help prevent and treat worsening renal failure.

Navigating a Complex Case of Mycobacterium Xenopi in a Patient with Blue Rubber Bleb Nevus Syndrome.

Introduction: Blue rubber bleb nevus syndrome is a rare disorder of venous malformations, with around 200 cases reported. We present a case of Mycobacterium xenopi infection in a patient with blue rubber bleb nevus syndrome. Case Description: A 40-year-old female with blue rubber bleb nevus syndrome, asthma, and bronchiectasis came to the pulmonology clinic with shortness of breath and a cough. She was recently admitted for a bronchiectasis exacerbation but continued to have a worsening productive cough and fevers. The most recent CT scan of the chest showed interval stable right upper lobe fibrocavitary disease, demonstrating gradual progression over two years. She had occasional positive cultures for Mycobacterium Avium Complex and M. xenopi one year previously, assumed to be a colonizer and not treated. Most recent hospital cultures were negative for bacteria and an acid-fast bacilli smear. She was sent to the emergency department for bronchiectasis exacerbation and returned to the clinic six weeks later with two sputum cultures growing M. xenopi. It was decided to treat M. xenopi as this was likely the cause of her cavitary lung lesion and frequent infections. Azithromycin, rifampin, and sulfamethoxazole/trimethoprim were initiated. Intravenous amikacin was added later on. She finally had a right partial lung resection done after one year at an outside hospital. She was on and off antibiotics for M. xenopi for approximately three years with negative repeat cultures for non-tuberculous mycobacteria. Conclusion: Due to the high mortality of M. xenopi infections (which can be as high as 69%), treatment of at least twelve months is recommended. To our knowledge, this is the first reported case of M. xenopi in a patient with blue rubber bleb nevus syndrome. LEARNING POINTS: The decision to initiate treatment for non-tuberculous mycobacterium infections is often challenging with prolonged treatment.Lifetime monitoring is required in patients with blue rubber bleb nevus syndrome, which can have pulmonary complications.M. xenopi has the highest mortality among non-tuberculous mycobacterium infections and requires at least 12 months of treatment.

Early real-world implant experience with a helix-fixation ventricular leadless pacemaker.

BACKGROUND: Roughly one in six patients receiving conventional transvenous pacemaker systems experience significant complications within 1 year of implant, mainly due to the transvenous lead and subcutaneous pocket. A new helix-fixation single-chamber ventricular leadless pacemaker (LP) system capable of pre-deployment exploratory electrical mapping is commercially available. Such an LP may mitigate complications while streamlining the implantation. In this study, the initial real-world implant experience of the helix-fixation LP was evaluated following its commercial release. METHODS: In patients indicated for single-chamber right ventricular pacing, helix-fixation Aveir VR LPs (Abbott, Abbott Park, IL) were implanted using the dedicated loading tool, introducer, and delivery catheter. Implant procedural characteristics, electrical parameters, and any 30-day procedure-related adverse events of consecutive implant attempts were retrospectively evaluated. RESULTS: A total of 167 patients with Class I indication for permanent pacing received implants in four North American centers (57% male, 70 years old). Pre-fixation electrical mapping of potential sites allowed repositioning to be avoided in 95.7% of patients. Median [interquartile range] LP procedure and fluoroscopy durations were 25.5 min [20.0, 35.0] and 5.7 min [4.0, 9.2], respectively. Pacing capture threshold, sensed R-wave amplitude, and impedance were 0.8 V [0.5, 1.3], 9.0 mV [6.0, 12.0], and 705 Ω [550, 910], respectively. Implantation was successful in 98.8% of patients, with 98.2% free from acute adverse events. CONCLUSIONS: The initial, real-world experience of the helix-fixation ventricular leadless pacemaker demonstrated safe and efficient implantation with minimal repositioning, viable electrical metrics, and limited acute complications.