scholarly journals MRI safety wih abandoned or functional epicardial pacing leads

2021 ◽  
Vol 22 (Supplement_2) ◽  
Author(s):  
AM Vuorinen ◽  
R Paakkanen ◽  
J Karvonen ◽  
J Sinisalo ◽  
M Holmstrom ◽  
...  
Keyword(s):  
Adverse Events ◽  
Atrial Pacing ◽  
Mri Safety ◽  
Mri Scan ◽  
Cardiac Stimulation ◽  
Mri Scans ◽  
Pacing Lead ◽  
Epicardial Pacing ◽  
Clinically Significant ◽  
Pacing Leads

Abstract Funding Acknowledgements Type of funding sources: Public hospital(s). Main funding source(s): HUS Medical Imaging Center research grant Background The Heart and Rhythm Society’s consensus statement 2017 approves magnetic resonance imaging (MRI) with cardiac implantable electronic devices (CIED), but excludes patients with epicardial and abandoned leads. Potential safety hazards of an MRI with epicardial pacing leads include heating of the tip of the lead and induction of current in the pacing lead resulting in inappropriate cardiac stimulation. Only a few small studies of MRI safety with epicardial pacing leads have been published and adverse events have been rare. The clinical dilemma remains, whether performing an MRI on a patient with CIED and epicardial pacing leads is safe. We have performed MRIs on patients with CIED and epicardial pacing leads when benefits have been considered to outweigh the risks after careful case-by-case evaluation following our institutional MRI with CIED safety protocol.  Purpose The aim of this study was to evaluate the safety of performing an MRI scan on patients with CIED and abandoned or functional epicardial pacing leads.  Methods All the clinically indicated MRI examinations conducted on adult patients with CIED and functional or abandoned epicardial leads (n = 24) performed in our hospital between November 2011 and October 2019 were included in this observational retrospective study. The data were retrospectively collected from electronic medical records.  Results Altogether 24 MRIs were performed to 16 patients with functional or abandoned epicardial pacing leads (Table). 93.8% (15/16) patients had congenital heart disease. Cardiac MRI was the most frequent examination (21/24, 91.7%). 66.7% of the MRI scans (16/24) were conducted on patients with functional epicardial pacing leads. In 5/24 (20.8%) MRIs, the patient was pacemaker-dependent. A clinically significant event occurred in one MRI scan. This was transient elevation of the pacing lead threshold in a patient with functional epicardial ventricular pacing lead, that was implanted 29 years prior to the MRI. In another patient with 30-year-old functional epicardial pacing leads, clinically significant irreversible elevation in atrial pacing lead impedance was detected 6 months after the MRI and unlikely related to previous MRI examination. None of the patients experienced sensations leading to cessation of the MRI scans. No clinically significant pacing lead parameter changes were detected after MRIs performed on patients with modern (implanted year 2000 or later) functional epicardial pacing leads or functional endocardial leads and abandoned epicardial leads.  Conclusions MRI examinations in patients with CIED and modern functional epicardial pacing leads were performed without detectable adverse events. Performing an MRI with old functional epicardial pacing leads may involve more risks.

scholarly journals Lateral Trochlear Inclination Angle: Measurement via a 2-Image Technique to Reliably Characterize and Quantify Trochlear Dysplasia

2020 ◽  
Vol 8 (10) ◽  
pp. 232596712095841
Author(s):  
Sheeba M. Joseph ◽  
Chris Cheng ◽  
Matthew J. Solomito ◽  
J. Lee Pace
Keyword(s):  
Measurement Technique ◽  
Trochlear Dysplasia ◽  
Intraclass Correlation ◽  
Single Image ◽  
Image Measurement ◽  
Mri Scan ◽  
Morphologic Characteristics ◽  
Mri Scans ◽  
Image Technique ◽  
Dejour Classification

Background: Trochlear dysplasia (TD) is a risk factor for patellar instability (PI). The Dejour classification categorizes TD but has suboptimal reliability. Lateral trochlear inclination (LTI) is a quantitative measurement of trochlear dysplasia on a single axial magnetic resonance imaging (MRI) scan. Hypothesis: A modified LTI measurement technique using 2 different axial MRI scans that reference the most proximal aspect of the trochlear cartilage on 1 image and the fully formed posterior condyles on the second image would be as reliable as and significantly different from the single-image measurement technique for LTI. Further, the 2-image LTI would adequately represent overall proximal trochlear morphologic characteristics. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: Patients aged 9 to 18 years treated for PI between 2014 and 2017 were identified. The Dejour classification was radiographically determined. Single-image LTI was measured on a single axial MRI scan at the most proximal aspect of visible trochlear cartilage. A 2-image LTI was measured from 2 separate MRI scans: 1 at the most proximal aspect of trochlear cartilage and the second at the fully formed posterior condyles. This 2-image LTI was repeated at 3 subsequent levels (the first measurement is referred to as LTI-1; repeated measurements are LTI-2, LTI-3, and LTI-4, moving distally). In total, 65 patients met the inclusion criteria, and 30 were randomly selected for reliability analysis. Results: Inter- and intrarater reliability trended toward more variability for single-image LTI (intraclass correlation coefficient [ICC], 0.86 and 0.88, respectively) than for 2-image LTI (ICC, 0.97 and 0.96, respectively). The Dejour classification had lower intra- and interrater reliability (ICC, 0.31 and 0.73, respectively). Average single-image LTI (9.2° ± 12.6°) was greater than average 2-image LTI-1 (4.2° SD ± 11.9°) ( P = .0125). Single-image LTI classified 60% of patients with PI as having TD, whereas the 2-image LTI classified 71% as having TD. The 2-image LTI was able to capture 91% of overall proximal trochlear morphologic characteristics. Conclusion: LTI has higher reliability when performed using a 2-image measurement technique compared with single-image LTI and Dejour classification. The strong correlation between 2-image LTI and average LTI shows that 91% of TD is represented on the most proximal axial image. Because the single-image measurement appears to underestimate dysplasia, previously described thresholds should be reexamined using this 2-image technique to appropriately characterize TD.

scholarly journals Randomized Double-blind Placebo-controlled Proof-of-concept Trial of Resveratrol for Outpatient Treatment of Mild Coronavirus Disease (COVID-19)

2021 ◽  
Author(s):  
Marvin R. McCreary ◽  
Patrick M. Schnell ◽  
Dale A. Rhoda
Keyword(s):  
Pulmonary Embolism ◽  
Adverse Events ◽  
Small Sample Size ◽  
Primary Outcome Measure ◽  
Small Sample ◽  
Double Blind ◽  
Phase 2 Study ◽  
Clinically Significant ◽  
Low Incidence ◽  
To Receive

Abstract Resveratrol is a polyphenol that has been well studied and has demonstrated anti-viral and anti-inflammatory properties that might mitigate the effects of COVID-19. Outpatients (N=105) were recruited from central Ohio in late 2020. Participants were randomly assigned to receive placebo or resveratrol. Both groups received a single dose of Vitamin D3 which was used as an adjunct. The primary outcome measure was hospitalization within 21 days of symptom onset; secondary measures were ER visits, incidence of pneumonia and pulmonary embolism. Five patients chose not to participate after randomization. Twenty-one day outcome was determined of all one hundred participants (mean [SD] age 55.6 [8.8] years; 61% female) (or their surrogates). There were no clinically significant adverse events attributed to resveratrol. Outpatients in this phase 2 study treated with resveratrol had a lower incidence compared to placebo of: hospitalization (2% vs. 6%, RR 0.33, 95% CI 0.04-3.10), COVID-related ER visits (8% vs. 14%, RR 0.57, 95% CI 0.18-1.83), and pneumonia (8% vs. 16%, RR 0.5, 95% CI 0.16-1.55). One patient (2%) in each group developed pulmonary embolism (RR 1.00, 95% CI: 0.06-15.55). This underpowered study was limited by small sample size and low incidence of primary adverse events. A larger trial could determine efficacy.TRIAL REGISTRATIONS: ClinicalTrials.gov NCT04400890 26/05/2020; FDA IND #150033 05/05/2020

Abstract 11945: Indications and Outcomes Following Transvenous Extraction of ICD versus Pacemaker Leads

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Eric W Black-Maier ◽  
Sean D Pokorney ◽  
Robert K Lewis ◽  
Alexander Christian ◽  
Ruth A Greenfield ◽  
...  
Keyword(s):  
Adverse Events ◽  
Dwell Time ◽  
Clinical Success ◽  
Lead Extraction ◽  
Index Hospitalization ◽  
Lead Failure ◽  
Icd Leads ◽  
Pacemaker Leads ◽  
Pacing Lead ◽  
Major Adverse Events

Introduction: Percutaneous transvenous lead extraction of cardiovascular implantable electronic devices (CIEDs) is increasingly common. Although ICD leads are widely considered to be more difficult to extract than pacemaker leads, there are few direct comparisons. Methods/Results: Using a cohort of 368 consecutive patients undergoing lead extraction (dwell time >1 year) between 2005-2012, we compared baseline characteristics/outcomes in extractions involving pacing versus ICD leads. We defined major adverse events (MAE) as any events/complications that required procedural intervention, transfusion, or that resulted in death or serious harm during index hospitalization. Median age was 60.6 yrs and 29.6% were women. There were 136 (37%) pacing lead extractions and 232 (63%) ICD lead extractions. Pacing leads had a longer dwell time (6.14 yrs [IQR 1.2-10.9 ] versus 4.4 yrs [IQR 1.1-6.4], p<0.001) and higher median LVEF (55% [IQR 35-55] vs. 30% [IQR 20-40], p<0.001) compared with ICD lead patients. Indications for pacing and ICD lead extractions included sepsis/endocarditis (21.3% vs. 24.6%, p=0.48), pocket infection (40.4% vs. 34.9%, p=0.29), and lead failure (15.4% vs. 38.8%, p<0.001). There were no significant differences between pacing and ICD lead extractions in median fluoroscopy time (5.5 vs. 8.5 minutes, p=0.86) or femoral bailout rate (4.4% vs. 5.2%, p=0.73). There were similar rates of all-cause MAE during index hospitalization (5.1% vs. 5.6%), death (2.2% vs 3.2%) and clinical success (97.0% vs. 97.0%, p=0.55) in pacemaker and ICD extractions, respectively. Conclusions: ICD leads are more commonly extracted relative to pacemaker leads, and this difference is driven by larger numbers of lead failure within ICD leads. Despite much longer dwell times, major adverse events were similar in pacing lead cases compared with ICD extractions.

scholarly journals Safety and Outcomes of Linezolid Use for Nocardiosis

2020 ◽  
Vol 7 (4) ◽  
Author(s):  
Natalie Davidson ◽  
Matthew J Grigg ◽  
Sarah L Mcguinness ◽  
Robert J Baird ◽  
Nicholas M Anstey
Keyword(s):  
Adverse Events ◽  
Hospital Setting ◽  
Drug Susceptibility ◽  
Therapeutic Drug ◽  
Primary Analysis ◽  
Safety And Efficacy ◽  
Treatment Regimens ◽  
Linezolid Therapy ◽  
Tropical Australia ◽  
Clinically Significant

Abstract Background Tropical Australia has a high incidence of nocardiosis, with high rates of intrinsic antimicrobial resistance. Linezolid, the only antimicrobial to which all local Nocardia species are susceptible, has been recommended in empirical combination treatment regimens for moderate–severe Nocardia infections at Royal Darwin Hospital (RDH) since 2014. We report the safety and efficacy of linezolid use for nocardiosis in this setting. Methods We identified cases through a retrospective review of all RDH Nocardia isolates from December 2014 to August 2018 and included 5 linezolid-treated cases from a previous cohort. Laboratory, demographic, and clinical data were included in the primary analysis of safety and treatment outcomes. Results Between 2014 and 2018, Nocardia was isolated from 35 individuals; 28 (80%) had clinically significant infection and 23 (82%) received treatment. All isolates were linezolid-susceptible. Safety and efficacy were assessed for 20 patients receiving linezolid-containing regimens and 8 receiving nonlinezolid regimens. Median linezolid induction therapy duration was 28 days. Common adverse effects in those receiving linezolid were thrombocytopenia (45%) and anemia (40%). Adverse events prompted discontinuation of trimethoprim-sulfamethoxazole more often than linezolid (40% vs 20%). Linezolid therapeutic drug monitoring was used in 1 patient, with successful dose reduction and outcome. There was no difference in 30-day survival between those treated with linezolid (90%) vs no linezolid (87%). One Nocardia-attributed death occurred during linezolid therapy. Conclusions Linezolid is safe and efficacious in empirical treatment for moderate to severe nocardiosis in a monitored hospital setting, with 100% drug susceptibility and no difference in adverse events or outcomes compared with nonlinezolid regimens.

scholarly journals COMPLETE FOUR CHAMBER RESYNCHRONIZATION VIA NOVEL PERCUTANEOUS EPICARDIAL PACING LEAD

2020 ◽  
Vol 75 (11) ◽  
pp. 269
Author(s):  
Martin van Zyl ◽  
Omar Ziad Yasin ◽  
Adetola Ladejobi ◽  
Vaibhav Vaidya ◽  
Alan Sugrue ◽  
...  
Keyword(s):  
Pacing Lead ◽  
Epicardial Pacing ◽  
Epicardial Pacing Lead

scholarly journals Safety and efficacy of restarting immune checkpoint inhibitors after clinically significant immune-related adverse events in metastatic renal cell carcinoma

2020 ◽  
Vol 8 (1) ◽  
pp. e000144 ◽  
Author(s):  
Sarah Abou Alaiwi ◽  
Wanling Xie ◽  
Amin H Nassar ◽  
Shaan Dudani ◽  
Dylan Martini ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Adverse Events ◽  
Cell Carcinoma ◽  
Median Time ◽  
Immune Checkpoint ◽  
Renal Cell ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Safety And Efficacy ◽  
Clinically Significant

BackgroundImmune checkpoint inhibitors (ICI) induce a range of immune-related adverse events (irAEs) with various degrees of severity. While clinical experience with ICI retreatment following clinically significant irAEs is growing, the safety and efficacy are not yet well characterized.MethodsThis multicenter retrospective study identified patients with metastatic renal cell carcinoma treated with ICI who had >1 week therapy interruption for irAEs. Patients were classified into retreatment and discontinuation cohorts based on whether or not they resumed an ICI. Toxicity and clinical outcomes were assessed descriptively.ResultsOf 499 patients treated with ICIs, 80 developed irAEs warranting treatment interruption; 36 (45%) of whom were restarted on an ICI and 44 (55%) who permanently discontinued. Median time to initial irAE was similar between the retreatment and discontinuation cohorts (2.8 vs 2.7 months, p=0.59). The type and grade of irAEs were balanced across the cohorts; however, fewer retreatment patients required corticosteroids (55.6% vs 84.1%, p=0.007) and hospitalizations (33.3% vs 65.9%, p=0.007) for irAE management compared with discontinuation patients. Median treatment holiday before reinitiation was 0.9 months (0.2–31.6). After retreatment, 50% (n=18/36) experienced subsequent irAEs (12 new, 6 recurrent) with 7 (19%) grade 3 events and 13 drug interruptions. Median time to irAE recurrence after retreatment was 2.8 months (range: 0.3–13.8). Retreatment resulted in 6 (23.1%) additional responses in 26 patients whose disease had not previously responded. From first ICI initiation, median time to next therapy was 14.2 months (95% CI 8.2 to 18.9) and 9.0 months (5.3 to 25.8), and 2-year overall survival was 76% (95%CI 55% to 88%) and 66% (48% to 79%) in the retreatment and discontinuation groups, respectively.ConclusionsDespite a considerable rate of irAE recurrence with retreatment after a prior clinically significant irAE, most irAEs were low grade and controllable. Prospective studies are warranted to confirm that retreatment enhances survival outcomes that justify the safety risks.

Transatrial Endocardial Placement of Epicardial Pacing Lead

2015 ◽  
Vol 31 (2) ◽  
pp. 127-128
Author(s):  
Karthik V. Ramakrishnan ◽  
Othman A. Aljohani ◽  
Anitha S. John ◽  
Pranava Sinha
Keyword(s):  
Pacing Lead ◽  
Epicardial Pacing ◽  
Epicardial Pacing Lead

scholarly journals Randomized Trial on the Safety, Tolerability, and Immunogenicity of MenACWY-CRM, an Investigational Quadrivalent Meningococcal Glycoconjugate Vaccine, Administered Concomitantly with a Combined Tetanus, Reduced Diphtheria, and Acellular Pertussis Vaccine in Adolescents and Young Adults

2010 ◽  
Vol 17 (4) ◽  
pp. 537-544 ◽  
Author(s):  
Roberto Gasparini ◽  
Michele Conversano ◽  
Gianni Bona ◽  
Giovanni Gabutti ◽  
Alessandra Anemona ◽  
...  
Keyword(s):  
Young Adults ◽  
Adverse Events ◽  
Randomized Trial ◽  
Conjugate Vaccine ◽  
Antibody Responses ◽  
Adolescents And Young Adults ◽  
Tdap Vaccine ◽  
Glycoconjugate Vaccine ◽  
Clinically Significant ◽  
Quadrivalent Meningococcal Conjugate Vaccine

ABSTRACT This study evaluated the safety, tolerability, and immunogenicity of an investigational quadrivalent meningococcal conjugate vaccine, MenACWY-CRM, when administered concomitantly with a combined tetanus, reduced diphtheria, and acellular pertussis (Tdap) vaccine, in subjects aged 11 to 25 years. Subjects received either MenACWY-CRM and Tdap, MenACWY-CRM and saline placebo, or Tdap and saline placebo. No significant increase in reactogenicity and no clinically significant vaccine-related adverse events (AEs) occurred when MenACWY-CRM and Tdap were administered concomitantly. Similar immunogenic responses to diphtheria, tetanus, and meningococcal (serogroups A, C, W-135, and Y) antigens were observed, regardless of concomitant vaccine administration. Antipertussis antibody responses were comparable between vaccine groups for filamentous hemagglutinin and were slightly lower, although not clinically significantly, for pertussis toxoid and pertactin when the two vaccines were administered concomitantly. These results indicate that the investigational MenACWY-CRM vaccine is well tolerated and immunogenic and that it can be coadministered with Tdap to adolescents and young adults.

Sign in / Sign up

Export Citation Format

Share Document