Abbott Park Research Articles

Chronic wireless communication between dual-chamber leadless pacemaker devices

BackgroundAveir DR (Abbott, Abbott Park, IL) is a dual-chamber leadless pacemaker (LP) system with distinct atrial and ventricular LPs (ALP, VLP) that communicate wirelessly to deliver atrioventricular synchronous pacing. Success rates of these implant-to-implant (i2i) transmissions have not been systematically evaluated. ObjectiveThis study aims to evaluate chronic i2i success rates in a clinical setting. MethodsPatients meeting standard dual-chamber pacing indications were enrolled and implanted with dual-chamber LP systems as part of a prospective international clinical trial (Aveir DR i2i Study). The percent of successful i2i transmissions from ALP-to-VLP (A-to-V) and VLP-to-ALP (V-to-A) were interrogated from LPs in de novo patients using the device programmer at implant, discharge, and at 1, 3, and 6 months postimplant (1M, 3M, 6M). ResultsA total of 399 patients completed device implant and i2i diagnostic interrogation (62% male; age 69 years; 65% sinus node dysfunction, 32% atrioventricular [AV] block). Median A-to-V and V-to-A i2i success rates exceeded 90% of beats at all time-points from implant to 6M. The minority of patients with A-to-V or V-to-A i2i success in <70% of beats at implant (A-to-V: 19% of patients, V-to-A: 31% of patients) showed roughly 40% improvement by 1M, with this minority dropping to roughly 5% of patients by 6M. Improvement in i2i communication success may be attributed to reprogramming of i2i setting levels, natural changes in dominant posture, and device stabilization. ConclusionWireless implant-to-implant communication in the new dual-chamber leadless pacemaker system demonstrated successful transmissions in >90% of beats throughout the 6-month evaluation period. Communication success improved significantly over time postimplant for specific subgroups. Clinical Trial RegistrationAveir DR i2i Study, ClinicalTrials.gov ID NCT05252702.

Single-Center Experience on the Elective Hybrid Combination of Single Perclose + Angio-Seal VIP 8F Compared With Standard Dual Perclose During Percutaneous Endovascular Aortic Aneurysm Repair.

This single-center study aimed to assess patients who underwent intentional percutaneous endovascular aortic aneurysm repair (pEVAR) with Hybrid Technique combining a single Perclose (Abbott, Abbott Park, Illinois) Suture-Mediated Closure Device + single Angio-Seal VIP 8F (Terumo, Tokyo, Japan) and compare outcomes with the standard Dual Perclose technique. Materials and Methods: Consecutive elective pEVAR patients treated from November 2022 to November 2023, with healthy femoral accesses and introducer sheaths ≤20 French (F) outer diameter, were included. Coin-toss randomization determined whether a combination of single Perclose Device + single Angio-Seal VIP 8F (Hybrid Technique) or the standard double Perclose Devices (Dual Perclose) was used. In Hybrid Technique, a single Perclose device was positioned at 12 o'clock; a single Angio-Seal VIP 8F was placed after sheaths removal. Dual Perclose followed standard procedure. Primary endpoints included immediate hemostasis, sheath diameter differences, access conversion rate, technical success, and cost analysis. The study involved 60 pEVAR patients (median age=78, interquartile range [IQR]=72-85 years) within the inclusion criteria. In 14 (24%) cases, only 1 femoral access was studied. There were 106 pEVAR accesses, with 58 (54.7%) in the Hybrid Technique group and 48 (45.3%) in the Dual Perclose group. Both groups exhibited homogeneity in pre-operative characteristics and sheath diameter (Hybrid Technique-16F vs Dual Perclose-18F; p=0.202). Immediate hemostasis was achieved in 100% of the Hybrid Technique group vs 87.5% for the Dual Perclose group (p=0.006). Surgical access conversion was unnecessary. Technical success was 100%, with all 6 femoral bleeding cases after Dual Perclose resolved endovascularly, using additional devices. Cost analysis showed a median cost of 330 euros (IQR=0) for the Hybrid Technique group vs 384 euros (IQR=360-456) for the Dual Perclose group (p<0.001). Thirty-day mortality was 3%, in 2 fragile patients, without access-related complications. Multivariate analysis identified Dual Perclose access (odds ratio [OR]=35.6; 95% confidence interval [CI]=18.3-36.8; p<0.001) and obesity (OR=19.7; 95% CI=1.4-23.9.5; p<0.001) as independent risk factors for immediate hemostasis failure. Median follow-up was 134 days (IQR=41-227), with 1 Hybrid Technique case (2%) successfully treated with thrombin injection for a small femoral pseudoaneurysm after 62 days. The elective Hybrid Technique with combination of single Perclose Device + single Angio-Seal VIP 8F during pEVAR in selected patients appears to be non-inferior to the standard Dual Perclose procedure. It demonstrates a positive trend in reducing immediate hemostasis failure and costs. Both procedures achieved technical success and avoiding surgical access conversions. This study introduces a novel elective hybrid technique combining a single Perclose device with a single Angio-Seal VIP 8Fr for percutaneous endovascular abdominal aortic interventions. Results for hybrid technique showed 100% technical success and efficient immediate hemostasis, while costing less than standard dual Perclose procedure. Both procedures did not require surgical conversions. Despite being a single-center study, it demonstrates potential benefits of the intentional application of this hybrid technique towards minimally invasiveness. Obesity and dual Perclose technique were identified as independent risk factors for hemostasis failure, reaffirming the hybrid technique procedure's efficacy as well as and non-inferiority to standard procedure.

Use of the CardioMEMS Device in Children and Patients with Congenital Heart Disease: A Literature Review.

The CardioMEMS HF System (Abbott, Abbott Park, IL) is the first FDA- and CE-Mark-approved device for monitoring patients with heart failure, significantly reducing hospitalizations and improving the quality of life for NYHA class III non-congenital adult patients. This device, implanted percutaneously, allows the direct monitoring of pulmonary arterial pressure with the wireless transfer of pressure data to the clinician, who can adjust the therapy remotely. Limited experience exists regarding its use in patients with congenital heart disease (CHD). CardioMEMS device implantation is feasible and safe in selected adults and children with CHD. The potential of the device to reduce heart failure hospitalizations in this population is enormous, but further multi-center studies are needed to demonstrate its efficacy.

Outcomes After Heartmate 3 Left Ventricular Assist Device Implantation Using a 10 mm Outflow Graft.

The presence of adhesions and patent bypass grafts may create challenges for standard 14 mm outflow graft placement during left ventricular assist device implantation. We retrospectively describe our experience using a 10 mm Bioline Fusion graft (Getinge, Goteborg, Sweden) as the outflow graft in patients undergoing primary Heartmate 3 (Abbott, Abbott Park, IL) implantation. One hundred one patients underwent Heartmate 3 left ventricular assist device implantation, 80% via a thoracotomy approach, with the standard 14 mm outflow graft (78) or a 10 mm Bioline Fusion outflow graft (23). Initial postoperative rotor speed-to-flow ratio (the revolutions per minutes (RPMs) required to achieve a given flow) was significantly higher in 10 mm graft patients (1,472 vs. 1,283 RPM/L/min; p = 0.03), suggesting elevated resistance in the smaller graft. Furthermore, the initial postoperative vasoactive-inotrope score was higher in the 10 mm graft patients (24.1 vs. 17.6; p = 0.022). Postoperative outcomes were similar between groups. In conclusion, the use of a 10 mm graft was associated with higher RPMs needed to generate a given flow and a higher vasoactive-inotrope score, but these differences were not associated with increased right ventricular failure or mortality.

Quality assurance of add-on testing in plasma samples: stability limit for 29 biochemical analytes.

Clinical laboratories should guarantee sample stability in specific storage conditions for further analysis. The aim of this study is to evaluate the stability of plasma samples under refrigeration for 29 common biochemical analytes usually ordered within an emergency context, in order to determine the maximum allowable period for conducting add-on testing. A total of 20 patient samples were collected in lithium heparin tubes without gel separator. All analyses were performed using Alinity systems (Abbott Laboratories, Abbott Park, USA) and samples were stored at 2-8 °C. Measurements were conducted in primary plasma tubes at specific time points up to 48 hours, with an additional stability study in plasma aliquots extending the time storage up to 96 hours. The stability limit was estimated considering the total limit of change criteria. Of the 29 studied parameters, 24 demonstrated stabilities within a 48-hour storage period in primary plasma tubes. However, five analytes: aspartate aminotransferase, glucose, lactate dehydrogenase, inorganic phosphate and potassium evidenced instability at different time points (7.9 hours, 2.7 hours, 2.9 hours, 6.2 hours and 4.7 hours, respectively). The stability study in plasma aliquots showed that all parameters remained stable for 96 hours, except lactate dehydrogenase, with a stability limit of 63 hours. A reduced stability of primary plasma samples was observed for five common biochemical analytes ordered in an emergency context. To ensure the quality of add-on testing for these samples, plasma aliquots provide stability for a longer period.

Long-Term Ovarian Function Assessment After Haematopoietic Stem Cell Transplantation in Female Sickle Cell Anaemia Survivors.

Haematopoietic stem cell transplantation (HSCT) is a potentially curative treatment for sickle cell anaemia (SCA). While HSCT offers the possibility of disease remission, it can also lead to long-term complications, including gonadal dysfunction and premature menopause. We conducted a retrospective cohort study of female survivors who had hydroxyurea therapy and those who underwent post-HSCT follow-up for SCA at a teaching hospital in Lagos, Nigeria, between January 2019 and December 2022. Participants were eligible if they were at least five years post-HSCT or hydroxyurea treatment and had available serum samples for markers of ovarian function measurement. Demographic and clinical data were collected from the hospital register and patients' medical records. Serum levels of oestradiol, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and anti-Müllerian hormone (AMH) were measured using the Abbott Architect i1000SR chemiluminescent immunoassay analyzer (Abbott Diagnostics, Abbott Park, IL). Descriptive statistics and inferential analyses were used to assess the relationship between markers of ovarian function (FSH and AMH) and clinical parameters. There were statistically significant differences in the median serum levels of all the assessed endocrine hormones between the HSCT and non-HSCT (hydroxyurea) groups of SCA survivors. Up to 82.6% of the SCA survivors experienced ovarian dysfunction after HSCT treatment. Impaired ovarian function in SCA survivors was associated with a longer median follow-up duration than in SCA survivors who had normal ovarian function (12.0 vs. 7.5 years, p = 0.048). There were higher odds of impaired ovarian function in the SCA survivors who had myeloablative regimens than in those who had reduced intensity conditioning regimens (94.1% vs. 50.0%, p = 0.040). Our study highlights the significant impact of HSCT on long-term ovarian function in female SCA survivors. However, further prospective studies with larger sample sizes and longer follow-up periods are required to confirm our findings and elucidate the factors influencing ovarian function in SCA survivors of HSCT. In addition, studies are also needed to further elucidate the optimal transplant protocols and fertility preservation strategies to minimize gonadal toxicity and preserve reproductive potential in female SCA patients undergoing HSCT.

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

Roughly one in six patients receiving conventional transvenous pacemaker systems experience significant complications within 1year 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. 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. A total of 167 patients with Class I indication for permanent pacing received implants in four North American centers (57% male, 70years 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 25.5min [20.0, 35.0] and 5.7min [4.0, 9.2], respectively. Pacing capture threshold, sensed R-wave amplitude, and impedance were 0.8V [0.5, 1.3], 9.0mV [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. 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.

Assessing the impact of haemodynamic monitoring with CardioMEMS on heart failure patients: a cost-benefit analysis.

The objective of this study was to perform a cost-benefit analysis of the CardioMEMS HF System (Abbott Laboratories, Abbott Park, IL, USA) in a heart failure (HF) clinic in Spain by evaluating the real-time remote monitoring of pulmonary artery pressures, which has been shown to reduce HF-related hospitalizations and improve the quality of life for selected HF patients. Particularly, the study aimed to determine the value of CardioMEMS in Southern Europe, where healthcare costs are significantly lower and its effectiveness remains uncertain. This single-centre study enrolled all consecutive HF patients (N=43) who had been implanted with a pulmonary artery pressure sensor (CardioMEMS HF System); 48.8% were females, aged 75.5±7.0years, with both reduced and preserved left ventricular ejection fraction; 67.4% of them were in New York Heart Association Class III. The number of HF hospitalizations in the year before and the year after the sensor implantation was compared. Quality-adjusted life years gained based on a literature review of previous studies were calculated. The rate of HF hospitalizations was significantly lower at 1year compared with the year before CardioMEMS implantation (0.25 vs. 1.10 events/patient-year, hazard ratio 0.22, P=0.001). At the end of the first year, the usual management outperformed the CardioMEMS HF System. By the end of the second year, the CardioMEMS system is estimated to reduce costs compared with usual management (net benefits of €346). Based on the results, we suggest that remote monitoring of pulmonary artery pressure with the CardioMEMS HF System represents a midterm and long-term efficient strategy in a healthcare setting in Southern Europe.

Practical approach to confirm femoral artery patency after percutaneous closure for veno-arterial extracorporeal membrane oxygenation decannulation.

We describe a technique to assess blood flow distal to the decannulation site after deployment of Perclose ProGlide (Abbott Vascular, Abbott Park, Ill) in patients on femoral veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support. An antegrade distal perfusion catheter was placed in all patients, and decannulation was primarily performed at bedside (N = 11/12). With the VA-ECMO circuit switched off, a needle was inserted into the arterial tubing, passed through the femoral arterial cannula into the artery. The arterial cannula was removed over a wire and the previously placed Proglide Perclose sutures were secured. Back bleeding from the antegrade distal perfusion catheter, confirmed using a three-way connector, indicated blood flow to the superficial femoral artery. This was followed by confirmation of blood flow to the lower leg using a Doppler ultrasound. Hemostasis of the antegrade perfusion catheter was achieved through manual compression. We implemented this technique in 12 patients with a technical success rate of 100%. There were no ipsilateral leg ischemia, bleeding, pseudoaneurysm, or infection after decannulation. This technique allows prompt assessment of blood flow to the distal leg immediately following arterial decannulation.

Особливості ліпідного та вуглеводного обмінів у пацієнтів з гастроезофагеальною рефлюксною хворобою на тлі цукрового діабету 2-го типу залежно від наявності ожиріння

Особливості ліпідного та вуглеводного обмінів у пацієнтів з гастроезофагеальною рефлюксною хворобою на тлі цукрового діабету 2-го типу залежно від наявності ожиріння

COVID-19 Pandemic: Total Testing Cost Impact on Neisseria Gonorrhoeae and Chlamydia Trachomatis Testing and Positivity Rate in the Veteran Population

Abstract Introduction/Objective The College of American Pathologists (CAP) checklist includes the quality assurance (QA) monitoring of the rate of diagnosis of Neisseria Gonorrhoeae (NG) and/or Chlamydia trachomatis (CT) by the molecular laboratory. Recently, the societal impacts of the economic lockdowns of the COVID-19 pandemic had a significant effect on the number of tests. However, the impact on the total testing costs as well as the positivity rate has not been well studied in the Veteran population. Methods/Case Report Quarterly quality assurance data from October 1st, 2018, to December 31st, 2022, was reviewed to obtain both the test volume for CT/NG and the number of positive test results at a Veterans Affairs Medical Center (VAMC). In addition, the cost to perform each test in reagents and consumables was also noted. Quarter 1 at the VAMC begins in October of the prior calendar year. The quarters in the period of April 1st, 2020, to December 31st, 2020 (corresponding to Quarter 3 2020 to Quarter 1 2021), was analyzed and compared to both the quarterly data prior to and after this period to note the impact of the COVID-19 pandemic on the quality assurance data. Testing had been performed using the Abbott m2000 RealTime System (Abbott Park, Illinois). Results (if a Case Study enter NA) A total of 18,904 tests for CT/NG had been performed on the Veteran population during the study period. Of these 18,904 tests, 385 were positive for NG and 515 were positive for CT. Quarterly percentage rates on a quarterly basis ranged from 1.58% to 4.53% (CT) and 1.16% to 4.53% (NG) with average rates of 2.78% and 2.13%, for Chlamydia and Gonorrhea respectively. The total reagent and consumable cost for each test was $28.84 per test. The period of Quarter 3 2020 to Quarter 1 2021 was marked by a decrease in total tests (331, 713 and 781 tests respectively compared with 1,049 tests in the quarter just before this period) with a corresponding decreased total test cost expenditure ($9,546.04, $20,592,92, and $22,524.04 respectively compared with $30,253.16 in the quarter just before this period) for performed tests. There was also an increase in the positivity rate (the highest positivity rate for both CT and NG of 4.53% was noted in quarter 3 2020) in this period of Quarter 3 2020 to Quarter 1 2021. Conclusion The initial period of the COVID-19 pandemic was marred by widespread economic lockdowns that impacted the total number of CT and NG tests performed, total test expenditures for tests performed, as well as the positivity rate.

EVALUATION AND IMPLIMENTATION OF A COMMERCIAL QUALITY CONTROL PRODUCT TO MONITOR SERUM INDICES DETECTION IN DAILY ROUTINE USE

Abstract Introduction/Objective Clinical Chemistry analyzers measure serum indices of each sample. Serum indices affect patient result. Yet there is no current common practice of monitoring the Instruments ability to measure serum indices using a commercial QC product. In this study, we focused on such Q.C. product evaluation. Methods/Case Report We evaluated the implementation of daily routine use of serum indices QC. We used a commercially available Bio-Rad (Hercules, California, United States) LiquichekTM Serum Indices QC material on Abbott (Abbott Park, Illinois, United States) Architect c8000 Chemistry analyzers in National Guard Hospital, Jeddah, Saudi Arabia. We run the QC twice a day in three Instruments for Two months. Data transferred to Bio-Rad Unity Real Time, a QC data management software. Mean, standard deviation and coefficient of variation calculated for each Instrument. Results (if a Case Study enter NA) A total of 1,296 data points were collected. The QC performed well with a precision of % CV ≤ 1.97% Hemolysis, ≤ 2.67% Icterus and ≤ 6.80% Lipemia. The three instruments performed with a slightly different mean. No “out of control” situations observed. TAT was not affected. To mimic a possible day-to-day Lab scenario, the saline bottle used as HIL reagent was deliberately contaminated using a few drops of whole blood to study the effect of gross hemolysis reagent contamination on HIL readings. The commercial HIL quality control detected the problem. Its performance showed increase in Hemolysis, slight decrease in Icterus and a slight increase in Lipemia readings. Conclusion Bio-Rad Liquichek Serum Indices QC is easy to use with a long shelf life. It helps to monitor the instrument’s ability to detect the sample integrity. Results can be compared to peer group unlike the home brewed QC. Peer group comparison helps to monitor and troubleshoot any bias or shift from the peer group and brings benefit to the total QC process.

Transarterial Embolization of Simple Pulmonary Arteriovenous Malformations: Long-Term Outcomes of 0.018-Inch Coils versus Vascular Plugs

PurposeTo compare the safety, effectiveness, and persistence rates of 0.018-inch coils with those of Amplatzer vascular plugs (AVPs; Abbott Vascular, Abbott Park, Illinois) for the treatment of pulmonary arteriovenous malformations (PAVMs) in response to a growing concern that 0.018-inch coil embolization would increase the long-term persistence rate. Materials and MethodsThis is a retrospective, single-center study of a database (2002–2020) of 633 PAVM embolizations. Complex PAVMs and those not embolized with 0.018-inch coils or plugs were excluded. PAVM embolization material was classified into 4 groups: (a) 0.018-inch nonfibered coils (NFCs), (b) 0.018-inch fibered coils (FCs), (c) NFCs and FCs, or (d) plugs. Persistence was defined as flow through the PAVM on digital subtraction angiography (DSA) or as <30% diameter reduction of the aneurysmal sac on unenhanced computed tomography (CT). Kaplan–Meier analysis and Cox regression were used to assess PAVM’s persistence-free survival. ResultsA total of 312 PAVM embolizations with NFCs (43 PAVMs), FCs (127 PAVMs), NFCs and FCs (12 PAVMs), or plugs (130 PAVMs) in 109 patients (28% men; mean age = 49 years) were included. All PAVM embolizations were technically successful without any major adverse events. PAVM persistence-free survival rates at 10 years’ follow-up were 40.8% versus 44.7% in the NFC and FC groups (P = .22) and 47.3% versus 81.0% in the 0.018-inch coil (NFC or FC) and plug groups (P < .0001), respectively. There were 0.43 (79/182) and 0.08 (10/130) re-embolization procedures per PAVM in the 0.018-inch coil and plug groups, respectively (P < .001). ConclusionsPAVM embolization with 0.018-inch coils was safe, but persistence rate with PAVM embolization was significantly higher than that with plugs, with no significant differences between FCs and NFCs.

Abstract 188: Rescue Left Middle Cerebral Artery Stenting With Xience Skypoint Everolimus‐Eluting Stent: Technical Report

Introduction Drug‐eluting stent (DES) use in symptomatic intracranial atherosclerosis disease (ICAD) has been described in the literature using different guiding and distal access catheters. We describe a case of deployment of a Xience Skypoint everolimus‐eluting stent (EES) (Abbott Vascular, Abbott Park, Illinois) into a symptomatic stenosed left M1 segment using Armadillo catheter (Q'Apel, Fremont, CA) with a successful result. Methods Case report and review of literature Results 67‐year‐old woman with type II diabetes mellitus, hypertension, hyperlipidemia, and recent admission for transient ischemic attack (resolving right hemiparesis and mild dysnomia in the setting of severe left M1 segment stenosis with discharge on Aspirin, Clopidogrel and Atorvastatin), presented with recurrence of symptoms, and MRI brain showing left basal ganglia acute infarction. No tPA was given low NIHSS and resolution of symptoms. Patient’s aphasia and hemiparesis worsened with segmental hypoperfusion which resolved by maintaining high blood pressures with norepinephrine drip. Decision was made to deploy a drug eluting stent into the stenosed M1 segment. Through femoral access, a 7F long destination sheath was inserted to the left common carotid origin. A 7F Armadillo catheter was then inserted into the left internal carotid artery (ICA) terminus. ASAHI Prowater coronary guidewire was inserted over which Xience Skypoint EES deployment was attempted but was unsuccessful given difficulty traversing the ICA ophthalmic segment. Ultimately, Armadillo catheter was advanced over a Phenom catheter (Medtronic) with good access into the distal M1 segment. The Phenom intermediate catheter was then removed, and the 2.25 mm x 12 mm stent was introduced through the Prowater guidewire into the segment and inflated to a pressure of 8 atm, with restoration of blood flow. Postoperatively, SBP was lowered to prevent reperfusion injury. Patient’s exam stabilized with mild dysnomia and right hemiparesis without any elevated blood pressure requirements. At 5‐months follow‐up, patient’s exam was non‐focal with NIHSS 0 and repeat DSA showed no evidence of stent occlusion and patent M1 segment. Conclusion Xience Skypoint EES can be successful in treating symptomatic MCA stenosis refractory to maximal medical therapy with good long term results.

Vascular Complications in Transcatheter Aortic Valve Replacement With Plug-Based vs Suture-Based Closure Devices.

There are conflicting data regarding the efficacy and safety of suture vs plug-based vascular closure devices (VCDs) for large-bore catheter management in patients undergoing transcatheter aortic valve replacement (TAVR). We compared the rates of vascular complications (VCs) associated with 2 commonly used VCDs in a large cohort of patients undergoing TAVR. We conducted a single-centre, all-comer, prospective registry study, enrolling patients undergoing TAVR for symptomatic severe aortic stenosis (AS) between the years 2009 and 2022. Clinical outcomes were compared between patients undergoing closure of the femoral access point using the MANTA VCD (M-VCD) (Teleflex, Wayne, PA) vs the ProGlide VCD (P-VCD) (Abbott Vascular, Abbott Park, IL). The main outcome measures were researcher adjudicated events of VARC-2 defined major and minor VCs. Overall, 2368 patients were enrolled in the registry; 1315 (51.0% male, 81.0 ± 7.0 years) patients were included in the current analysis. P-VCD was used in 813 patients, whereas M-VCD was used in 502 patients. In-hospital VCs were more frequent in the M-VCD vs the P-VCD group (17.3% vs 9.8%; P < 0.001). This outcome was mainly driven by elevated rates of minor VCs in the M-VCD group, whereas no significant difference was observed for major VCs (15.1% vs 8.4%; P < 0.001 and 2.2% vs 1.5%; P= 0.33, respectively). In patients undergoing TAVR for severe AS, M-VCD was associated with higher rates of VCs. This outcome was mainly driven by minor VCs. The rate of major VCs was low in both groups.

Establishment of trimester-specific reference intervals of renal function tests and their predictive values in pregnant complications and perinatal outcomes: A population-based cohort study

ObjectivesIn this study, we aimed to establish the trimester-specific RIs of renal function tests (RFTs) in singleton pregnant women and investigate the associations between adverse perinatal outcomes and abnormal renal function laboratory results. MethodsThe results of RFTs and the associated medical records were retrieved from 16489 singleton pregnant women who underwent first- and third-trimester prenatal screening and gave a live birth at out institute between August 2018 and December 2019. The RFTs were performed on the automated immunochemistry platform ARCHITECT ci16200 (Abbott Laboratories Ltd, Abbott Park, Illinois, US) in the clinical laboratory of our institute. The nonparametric 2.5th-97.5th percentile intervals and the indirect Hoffmann methods were used to define the trimester-specific RIs. The associations between abnormal RFTs and adverse pregnancy outcomes was assessed statistically by logistic regression. ResultsThere was no significant difference between the direct observational and the indirect Hoffmann methods in establishing RIs of RFTs. Compared with RFTs in the first trimester, the concentrations of serum BUN and Crea were slightly decreased (p < 0.001), and the serum UA and Cys C levels were significantly elevated in the third trimester (p < 0.001). In the logistic regression analysis, high concentrations of UA, Crea, and Cys C in late pregnancy were associated with an increased risk of postpartum hemorrhage. Meanwhile, early pregnancy UA was associated with a modestly increased risk of GDM, GH, and PE. ConclusionIt is necessary to establish trimester-specific RIs for RFTs, in order to appropriately interpret laboratory results and to identify women with high risks of developing various adverse outcomes.

Retrieval of Chronically Implanted Dual-chamber Leadless Pacemakers in an Ovine Model.

The clinical utilization of leadless pacemakers (LPs) as an alternative to traditional transvenous pacemakers is likely to increase with the advent of dual-chamber LP systems. Since device retrieval to allow LP upgrade or replacement will become an important capability, the first such dual-chamber, helix-fixation LP system (Aveir DR; Abbott, Abbott Park, IL) was specifically designed to allow catheter-based retrieval. In this study, the preclinical performance and safety of retrieving chronically implanted dual-chamber LPs was evaluated. Atrial and ventricular LPs were implanted in the right atrial appendage and right ventricular apex of 9 healthy ovine subjects. After ≈2 years, the LPs were retrieved using a dedicated transvenous retrieval catheter (Aveir Retrieval Catheter; Abbott) by snaring, docking, and unscrewing from the myocardium. Comprehensive necropsy/histopathology studies were conducted to evaluate device- and procedure-related outcomes. At a median of 1.9 years postimplant (range, 1.8-2.6), all 18 of 18 (100%) LPs were retrieved from 9 ovine subjects without complications. The median retrieval procedure duration for both LPs, from first-catheter-in to last-catheter-out, was 13.3 minutes (range, 2.5-36.4). Postretrieval, all right atrial, and right ventricular implant sites demonstrated minimal tissue disruption, with intact fibrous tissue limited to the distal device body. No significant device-related trauma, perforation, pericardial effusion, right heart or tricuspid valve injury, or chronic pulmonary thromboembolism were observed at necropsy. This preclinical study demonstrated the safe and effective retrieval of chronically implanted, helix-fixation, dual-chamber LP systems, paving the way for clinical studies of LP retrieval.

B-323 Urinary Thebaine Improves Opioid Interpretation in Pain Management

Abstract Background Poppy seed from Papaver somniferum plant is used in bakery results in positive urine test for Morphine and Codeine up to 48 h. This leads to prescription compliance failure in the setting of clinical pain management. To mitigate misinterpretation, Thebaine testing was introduced to confirmatory opioid panel. Thebaine is naturally found in poppy seeds but not in prescription opiate formularies. A positive Thebaine result helps identify poppy seed consumption rather than from opioid prescription abuse. Method Each of the seven healthy adult volunteers (age 20–50) consumed one poppy seed filled kolache. Urine samples were then collected from each person at pre and post-consumed time points at 2, 4, and 24 h. All samples were screened on Abbott Architect c16000 immunoassay (Abbott Park, IL) for opioids at 300 ng/mL cutoff. The samples were quantitated using ThermoFisher Vanquish Quantis LC-MS/MS (Waltham, MA) for Codeine, Morphine, and Thebaine at AMR 10–500 ng/mL, 10–500 ng/mL, and 5–250 ng/mL, respectively. Data acquisition/analyses were performed on TraceFinder software. The deuterated internal standards were purchased from Cerilliant Corporation (Round Rock, TX). All samples met calibrators and quality controls quality criteria. Results All post-consumption immunoassay results were positive for opioid. All LC-MS/MS positive results showed various levels of Codeine, Morphine, and Thebaine at 230–4300 ng/mL, 9–290 ng/mL, and 5–210 ng/mL, respectively (Fig. 1).Fig. 1. Conclusion Poppy seed consumption results in positive opioid class by immunoassay and positives Codeine, Morphine by LC-MS/MS. Detection of Thebaine in these samples would enable accurate clinical interpretation for poppy seed dieters and abusers of Codeine and Morphine prescription.

B-303 Comparison of Tacrolimus Concentrations Obtained By the Newly Approved Alinity i Tacrolimus Assay With a Reference Liquid-Chromatography Combined With Tandem Mass spectrometry Assay

Abstract Background Tacrolimus belongs to the calcineurin-inhibitor class of medications and used for preventing and maintenance of organ rejection in transplant recipients alone or in combination with other medications. Due to narrow therapeutic window and significant nephrotoxicity, this drug is routinely monitored with a suggested therapeutic range of 5–15 ng/mL. Recently, Abbott Laboratories (Abbott Park, IL) received FDA approval for using tacrolimus immunoassay on the Alinity i platform. We compared tacrolimus values in 101 transplant patients using Alinity i analyzer and a reference method based on liquid chromatography combined with mass tandem spectrometry (LC-MS/MS). Methods Tacrolimus immunoassay on the Alinity i analyzer is a chemiluminescent microparticle immunoassay (CMIA) requiring pretreatment of whole blood specimen prior to analysis. The analytical measurement range of the assay is 2–30 ng/mL. The left-over blood specimens were sent to Eurofins-Viracor reference laboratory in Lenexa, KS for analysis using LC-MS/MS method. After liquid-liquid extraction, specimens were analyzed using ascomycin as the internal standard for the presence of tacrolimus (assay is capable of analyzing other immunosuppressants simultaneously). UPLC C-18 column (waters) was used for separation using two mobile phases (A: 2.0 mM ammonium acetate in 0.1% formic caid in water and B: 2.0 mM ammonium acetate in 0.1% formic acid in methanol). Mass spectrometer was operated in positive ionization electrospray mode (tacrolimus m/z 821.6 &amp;gt; 768.6, ascomycin m/z 809.756.6. Results The total precision of the low control was 3.6% (mean: 4.48 ng/mL; CV 0.16 ng/mL, n = 20) while the total precision of the high control was 5.1% (mean: 25.4 ng/mL, SD: 1.29 ng/mL, n = 20). The linearity of the assay (2.0–30.0 ng/mL) was verified by running various calibrators as unknown. Comparing tacrolimus values in specimens from 101 transplant patients (49 kidney, 19 bone marrow transplant, 16 liver and 15 heart transplant) using the reference method (LC-MS/MS) as the x-axis and the corresponding values obtained by the tacrolimus immunoassay using Alinity I analyzer, we observed the following regression equation: y = 0.97 x + 1.005 (n = 101, r = 0.95). For kidney transplant recipients, the regression equation was y = 0.96 + 1.20 (n = 49, r = 0.94). Discussion Excellent correlation between tacrolimus values obtained by the newly FDA approved tacrolimus immunoassay with the reference LC-MS/MS based assay indicates further improvement in the performance of immunoassays for therapeutic drug monitoring of immunosuppressants. This may be due to reduced cross-reactivity of metabolites as indicated in the package insert. Conclusions The newly approved tacrolimus immunoassay for the application on the Alinity I analyzer can be used for routine therapeutic drug monitoring of tacrolimus in clinical laboratories.

B-324 Comparison of Two Urine Fentanyl Assays on the Abbott Alinity c Analyzer

Abstract Background Mass spectrometry (MS) remains the gold standard, however immunoassays can provide a preliminary test result while the patient is still in the emergency room or clinic. Methods The ARK Fentanyl II assay (ARK Diagnostics Inc, Fremont, CA) was compared to the Immunalysis SEFRIA Fentanyl (Immunalysis Corporation, Pomona, CA) assay on the Abbott Alinity c analyzer (Abbott Park, IL) using leftover deidentified urine samples. MS analysis was performed at ARUP Laboratories (Salt Lake City, UT) to quantitate the amount of fentanyl or norfentanyl metabolite in each sample. Medications prescribed at the time of sampling were reviewed to assess for possible cross reactivity with the assays. Results A total of 142 urine samples were analyzed with 70 MS positive and 72 MS negative samples. Positive and negative assay specific quality control precision (N = 10) was 3.0% and 9.6% CV for the ARK Fentanyl II assay and 10.2% and 15.9% CV for the Immunalysis SEFRIA assays respectively. ARK Fentanyl II Sensitivity = 95.7%, Specificity = 94.4%, PPV = 94.4%, NPV = 95.8% and Efficiency = 95.1% compared to the Immunalysis SEFRIA Fentanyl Sensitivity = 95.7%, Specificity = 81.9%, PPV = 83.8%, NPV = 95.2% and Efficiency = 88.7%. Upon repeat analysis, 4 of 4 ARK and 6 of 13 Immunalysis false positives reported as negative, indicating some variability around the cutoff concentration. Possible carryover from high samples has also been reported (ARK Technical Note 20-001-August 2020) and high samples were analyzed prior to some of the false positive samples. Six MS positive samples were reported as negative (false negatives), 3 samples by each of the assays. However, 4/6 of those samples had combined fentanyl and norfentanyl concentrations &amp;lt;3 ng/mL by MS. Conclusion The ARK Fentanyl II and Immunalysis SEFRIA assays demonstrated acceptable performance in the detection of fentanyl in our patient population.