P425Single procedure pace and ablate. evaluation of efficacy and safety comparing three different vascular routes

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
M Abbas ◽  
L Whittaker ◽  
M Chapman ◽  
A R Thornley ◽  
D Towmey ◽  
...  

Abstract Funding Acknowledgements No financial support for this study Introduction Permanent pacemaker implantation combined with AVN ablation is a well-established treatment for rate control in patients with atrial fibrillation refractory to medical therapy. At the same sitting, this has been achieved in a single procedure via the subclavian vein (SCV) for both pacemaker implantation and AVN ablation, by pacemaker implantation via the SCV with femoral access for AVN ablation or by using the femoral vein (FV) for leadless pacemaker implantation and AVN ablation with a coaxial single-puncture technique. We evaluated all combined procedures (pacemaker implantation and AVN ablation at the same sitting) performed in a single centre over 9 years comparing clinical outcomes, complications rates and procedure times. Statistical methods:  Continuous variables are described as mean ± standard deviation (SD), and statistical differences between groups were evaluated by one-way ANOVA. A X2 test was used for categorical variables, with Fisher’s exact test for any field where the expected frequency was ≤5 with pvalue < 0.05 considered as statistically significant. The statistical analysis was performed using SPSS software package.  Results   141 patients underwent AVN ablation at our institution as part of a ‘pace and ablate’ single procedure strategy between 14/2/11 and 10/6/19. 61 patients had a combined procedure via the SCV, 66 patients had pacemaker implanted via the SCV and AVN ablation via the FV in the same sitting and 14 patients had leadless pacemaker (Micra) implantation and AVN ablation via the FV. Our findings suggest that the fluoroscopy time as well as the total catheter laboratory time were much less in the Micra group compared to the other groups. In the conventional pacemaker groups (group 1 and 2), the fluoroscopy time was not statistically different between the two. There was a trend towards acute procedural failure, switching to another access as well as a higher complication rate in the SCV group, however this has not reached statistical significance.  Conclusion   Our early data suggests that pacemaker implantation and AVN ablation with a coaxial single femoral vein puncture technique is safe and takes less fluoroscopy time as well as total laboratory time. Procedural outcomes All (n = 141) Group 1: SCV (n = 61) Group 2: FV (n = 66) Group 3: Micra (n = 14) P-value Total cath-lab time (mins) 113.1 ± 40.4 106.2 ± 37.2 125.7 ± 42.5 86.9 ± 23.1 0.001 Total fluoroscopy time (mins) 8.8 ± 7.6 11 ± 7.8 7.7 ± 7.6 4.5 ± 3 0.0001 Acute procedural failure, n (%) 9 (6.4) 7 (11.5) 2 (3) 0 (0) **0.6 Complications, n (%) 7 (4.9) 5 (8.2) 2 (3) 0 (0) **0.62 **Fisher"s exact test applied to analysis of Micra VS Other methods

2019 ◽  
Vol 5 (5) ◽  
pp. 639-640
Author(s):  
James Gabriels ◽  
Joseph Donnolly ◽  
Stuart Beldner ◽  
Jonathan Willner ◽  
Omid Rahmani ◽  
...  

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Dawn K Beland ◽  
Gregory Panza

Thrombolytic treatment for patients who wake with acute ischemic stroke based on MRI DWI-FLAIR mismatch was added to AHA’s 2019 stroke guidelines. While changes were implemented to facilitate care in 2019, it was determined that managing each patient on a case-by-case basis would best use system resources. The spring of 2020 brought new challenges in delay to hospital arrival due to COVID-19. Purpose: Evaluate the current process of managing potential wake up treatment eligible patients. Methods: All ischemic stroke discharges during CT’s rise and peak of the pandemic were reviewed, January 1 - May 31, 2020. Records were reviewed to determine time of arrival, onset or last seen well, time found, NIHSS, treatment or hyperacute MRI done, and any contraindication based on wake up criteria. A chi-square of proportions or Fisher’s Exact test was used to examine the association between month of discharge and patient characteristics for categorical variables. A Kruskal-Wallis H test was used for the continuous NIHSS variable. Results: Since the first COVID-19 patients were admitted in early March, results from January and February were combined (Group 1 n=122) and compared to March, April and May (Group 2 n=143). There was a non-significant (p=0.48) increase from group 1 (62.3%) to group 2 (66.4%) in the percentage arriving more than 4.5 hours from onset or LSW. In addition, group 1 had higher NIHSSs than group 2 (median, IQR=6, 9 vs 3, 10, respectively), but this was not significant (p=0.27, H=1.21). This did however translate into fewer meeting wake up criteria for treatment during the rise and peak period (Group 1=6.6%, Group 2=2.8%; p=0.15). Use of hyperacute MRI was significantly higher in group 1 than group 2 (5.7% vs 0%, p=0.004) since no patients received a hyperacute MRI during peak pandemic. Conclusions: While more patients were expected to be eligible for acute thrombolytics using the wake up criteria due to delay in hospital arrival, this was not observed. Instead, patients arriving during the peak of the pandemic were less severe. Although a hyperacute MRI was still possible without confirmation of COVID-19 negative status, none were done. Enhancements to facilitate obtaining a hyperacute MRI are still needed regardless of reason for patient delay to hospital arrival.


2021 ◽  
Author(s):  
Hani Siddeek ◽  
Erick Jimenez ◽  
Matthew Ambrose ◽  
Elizabeth Braunlin ◽  
Julia Steinberger ◽  
...  

Background: In the pediatric population, conventional transvenous and epicardial pacemaker systems carry complications such as lead distortion due to growth/activity, in addition to other lead/pocket complications. Materials & methods: A retrospective review of pediatric leadless pacing at the University of Minnesota Masonic Children’s Hospital from 2018 to 2020 was performed. Rationale for pacing, demographics of patients, thresholds and longevity of devices were recorded. Results: Seven leadless pacemaker insertions and one removal were performed successfully, in patients weighing between 19 kg and 58 kg. Three patients had Micra implantation via internal jugular vein. One pericardial effusion occurred perioperatively in a 19 kg patient with baseline thrombocytopenia, sideroblastic anemia and Pearson Marrow Pancreas syndrome. Conclusion: Leadless pacemaker implantation/early retrieval is feasible in pediatric patients.


2021 ◽  
Vol 19 (2) ◽  
pp. 16-26
Author(s):  
V.N. Gorodin ◽  
◽  
D.L. Moysova ◽  
S.V. Zotov ◽  
A.A. Vanyukov ◽  
...  

Objective. To analyze polymorphisms of genes involved in hemostasis among patients with coronavirus disease 2019 (COVID 19) to improve the diagnosis of coagulopathy and prognosis of COVID-19 severity. Patients and methods. We have examined 52 patients with COVID-19 aged 33 to 84 years. Of them, 30 individuals (Group 1) were hospitalized with extremely severe (1A) and severe (1B) disease, whereas 22 patients with mild and asymptomatic disease were treated in outpatient departments (group 2). We assessed allelic variants of genes associated with hemostasis dysfunction (including FGB, FII, FV, FVII, F13A1, PAI-I, Gp1a, and Gp3a) using genomic DNA isolated from peripheral blood leukocytes. Polymorphisms were detected by polymerase chain reaction. Data analysis was performed using the Statistica, version 12 (StatSoft, USA). To compare independent categorical variables, we constructed contingency tables, performed Pearson chisquare test with Yates correction, Fisher exact test, and calculated relative risk (RR) [CI]. Results. COVID-induced coagulopathy (CAC) was diagnosed in 16.7% of patients; risk of CAC was identified in 30% of patients; sepsis-induced coagulopathy (SIC) was observed in 3.3% of patients; none of study participants had disseminated intravascular coagulation (DIC). Hemostasis impairments were more common in group 1A (RR = 2.28 [1.16–4.48]). Only patients from Group 1 had mutations in the gene encoding prothrombin (FII) –6.9% (RR = 1.78 [1.40–2.28]); protective polymorphisms in the FVII gene were more common in patients from Group 2 (χ2 = 3.28, р = 0.046); the rs 5985 polymorphism in the F13A1 gene was more common in patients from Group 1 (RR = 1.73 [1.06–2.82]). Patients with extremely severe COVID- 19 were more likely to have polymorphisms in the Gp1a gene (ITGA2) (RR =1.64 [1.05–2.56]) and F13A1 gene (χ2 = 2.67, р = 0.05), as well as homozygous mutation in the FII gene; they had no polymorphisms in the FVII gene (10976G→A). Thrombophilia, detected in 3 patients from Group 1, was a risk factor for thrombocytopenia (RR = 13.5 [3.56–51.23]), САС (RR = 9.0 [3.1–26.16]), and death (n = 4). The 4G allele (4G/4G, 4G/5G variants) in the PAI-I gene (rs 1799889), causing impaired fibrinolysis, was more frequently registered in patients with mild COVID-19 (91%) than in those with extremely severe COVID-19 (70%). It is possible that patients with extremely severe disease develop transient hyperfibrinolysis, which results in the transformation of local pulmonary COVID-19 into sepsis. Therefore, the 4G/4G and 4G/5G polymorphisms may have a protective role. Key words: hemostasis, COVID-19, polymorphism, genetics, COVID-induced coagulopathy


2016 ◽  
Vol 39 (7) ◽  
pp. 675-679 ◽  
Author(s):  
ALEXANDER KYPTA ◽  
HERMANN BLESSBERGER ◽  
MICHAEL LICHTENAUER ◽  
JUERGEN KAMMLER ◽  
THOMAS LAMBERT ◽  
...  

Heart Rhythm ◽  
2021 ◽  
Vol 18 (8) ◽  
pp. S204
Author(s):  
Ashwani Gupta ◽  
Muhammad Zubair Khan ◽  
Steven P. Kutalek

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
L Girardi ◽  
M Serdaroğulları ◽  
C Patassini ◽  
S Caroselli ◽  
M Costa ◽  
...  

Abstract Study question What is the effect of varying diagnostic thresholds on the accuracy of Next Generation Sequencing (NGS)-based preimplantation genetic testing for aneuploidies (PGT-A)? Summary answer When single trophectoderm biopsies are tested, the employment of 80% upper threshold increases mosaic calls and false negative aneuploidy results compared to more stringent thresholds. What is known already Trophectoderm (TE) biopsy coupled with NGS-based PGT-A technologies are able to accurately predict Inner Cell Mass’ (ICM) constitution when uniform whole chromosome aneuploidies are considered. However, minor technical and biological inconsistencies in NGS procedures and biopsy specimens can result in subtle variability in analytical results. In this context, the stringency of thresholds employed for diagnostic calls can lead to incorrect classification of uniformly aneuploid embryos into the mosaic category, ultimately affecting PGT-A accuracy. In this study, we evaluated the diagnostic predictivity of different aneuploidy classification criteria by employing blinded analysis of chromosome copy number values (CNV) in multifocal blastocyst biopsies. Study design, size, duration The accuracy of different aneuploidy diagnostic cut-offs was assessed comparing chromosomal CNV in intra-blastocysts multifocal biopsies. Enrolled embryos were donated for research between June and September 2020. The Institutional Review Board at the Near East University approved the study (project: YDU/20l9/70–849). Embryos diagnosed with uniform chromosomal alterations (single or multiple) in their clinical TE biopsy (n = 27) were disaggregated into 5 portions: the ICM and 4 TE biopsies. Overall, 135 specimens were collected and analysed. Participants/materials, setting, methods Twenty-seven donated blastocysts were warmed and disaggregated in TE biopsies and ICM (n = 135 biopsies). PGT-A analysis was performed using Ion ReproSeq PGS kit and Ion S5 sequencer (ThermoFisher). Sequencing data were blindly analysed with Ion-Reporter software. Intra-blastocyst comparison of raw NGS data was performed employing different thresholds commonly used for aneuploidy classification. CNV for each chromosome were reported as aneuploid according to 70% or 80% thresholds. Categorical variables were compared using Fisher’s exact test. Main results and the role of chance In this study, a total of 50 aneuploid patterns in 27 disaggregated embryos were explored. Single TE biopsy results were considered as true positive when they displayed the same alteration detected in the ICM at levels above the 70% or 80% thresholds. Alternatively, alterations detected in the euploid or mosaic range were considered as false negative aneuploidy results. When the 70% threshold was applied, aneuploidy findings were confirmed in 94.5% of TE biopsies analyzed (n = 189/200; 95%CI=90.37–37.22), while 5.5% showed a mosaic profile (50–70%) but uniformly abnormal ICM. Positive (PPV) and negative predictive value (NPV) per chromosome were 100.0% (n = 189/189; 95%CI=98.07–100.00) and 99.5% (n = 2192/2203; 95%CI=99.11–99.75) respectively. When the upper cut-off was experimentally placed at 80% of abnormal cells, a significant decrease (p-value=0.0097) in the percentage of confirmed aneuploid calls was observed (86.5%; n = 173/200; 95%CI=80.97–90.91), resulting in mosaicism overcalling, especially in the high range (50–80%). Less stringent thresholds led to extremely high PPV (100.0%; n = 173/173; 95%CI=97.89–100.00), while NPV decreased to 98.8% (n = 2192/2219; 95%CI=98.30–99.23). Furthermore, no additional true mosaic patterns were identified with the use of wide range thresholds for aneuploidy classification. Limitations, reasons for caution This approach involved the analysis of aneuploidy CNV thresholds at the embryo level and lacked from genotyping-based confirmation analysis. Moreover, aneuploid embryos with known meiotic partial deletion/duplication were not included. Wider implications of the findings: The use of wide thresholds for detecting intermediate chromosomal CNV up to 80% doesn’t improve PGT-A ability to discriminate true mosaic from uniformly aneuploid embryos, lowering overall diagnostic accuracy. Hence, a proportion of the embryos diagnosed as mosaic using wide calling thresholds may actually be uniformly aneuploid and inadvertently transferred. Trial registration number N/A


Author(s):  
G Malcolm Taylor ◽  
Scott A Barnett ◽  
Charles T Tuggle ◽  
Jeff E Carter ◽  
Herb A Phelan

Abstract Hypothesis In order to address the confounder of TBSA on burn outcomes, we sought to analyze our experience with the use of autologous skin cell suspensions (ASCS) in a cohort of subjects with hand burns whose TBSA totaled 20% or less. We hypothesized that the use of ASCS in conjunction with 2:1 meshed autograft for the treatment of hand burn injuries would provide comparable outcomes to hand burns treated with sheet or minimally meshed autograft alone. Methods A retrospective review was conducted for all deep partial and full thickness hand burns treated with split thickness autograft (STAG) at our urban verified burn center between April, 2018 to September, 2020. Exclusion criterion was a TBSA greater than 20%. The cohorts were those subjects treated with ASCS in combination with STAG (ASCS(+)) versus those treated with STAG alone (ASCS(-)). All ASCS(+) subjects were treated with 2:1 meshed STAG and ASCS overspray while all ASCS(-) subjects had 1:1, piecrust, or unmeshed sheet graft alone. Outcomes measured included demographics, time to wound closure, proportion returning to work (RTW), and length of time to RTW. Mann-Whitney U test was used for comparisons of continuous variables, and Fishers Exact test for categorical variables. Values are reported as medians and 25 th and 75 th interquartile ranges. Results Fifty-one subjects fit the study criteria (ASCS(+) n=31, ASCS(-) n=20). The ASCS(+) group was significantly older than the ASCS(-) cohort (44 yrs [32, 54] vs 32 [27.5, 37], p=0.009) with larger %TBSA burns (15% [9.5, 17] vs 2% [1, 4], p <0.0001), and larger size hand burns (190 cm2 [120, 349.5] vs 126 cm2 [73.5, 182], p=0.015). Comparable results were seen between ASCS(+) and ASCS(-), respectively, for time to wound closure (9 days [7, 13] vs 11.5 [6.75, 14], p=0.63), proportion RTW (61% vs 70%, p=0.56), and days for RTW among those returning (35 [28.5, 57] vs 33 [20.25, 59], p=0.52). The ASCS(+) group had two graft infections with no reoperations, while ASCS(-) had one infection with one reoperation. No subjects in either group had a dermal substitute placed. Conclusion Despite being significantly older, having larger hand wounds, and larger overall wounds within the parameters of the study criteria, patients with 20% TBSA burns or smaller whose hand burns were treated with 2:1 mesh and ASCS overspray had comparable time to wound closure, proportion of returning to work, and time to return to work as subjects treated with 1:1 or pie-crust meshed STAG. Our group plans to follow this work with scar assessments for a more granular picture of pliability and reconstructive needs.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Moghniuddin Mohammed ◽  
Amit Noheria ◽  
Seth Sheldon ◽  
Madhu Reddy

Introduction: There are no randomized controlled trials that compared the outcomes of leadless pacemaker (L-PPM) implantation with transvenous pacemaker (TV-PPM) and there is scarcity of data on real world outcomes. Methods: We queried National Inpatient Sample to identify all adult patients who had primary discharge diagnosis of conduction disorders or tachy-arrhythmias and excluded patients who had a concomitant procedure for valve replacement, coronary artery bypass grafting, ablation and/or cardiac implantable electronic device removal so that complications can be attributed to the pacemaker implantation. We included only procedures from November 2016 to December 2017 as Micra was the only available L-PPM during that period. For the comparison cohort we selected patients, during the same time period, who had a procedure code for single chamber pacemaker implantation in conjunction with right ventricular lead placement. We performed 1:1 propensity score matching and the variables used for matching are marked with asterisk in Table 1. All the codes used to identify complications has been previously validated from the Micra Post-approval registry and Coverage with Evidence Study. Results: Total of 1,305 patients for L-PPM and 13,905 patients in the TV-PPM group were included. Baseline characteristics with standardized mean difference before and after matching are shown in Table 1. Briefly, patients in L-PPM group were younger but had higher co-morbidities compared to TV-PPM group. The complications before and after matching are shown in Table 2. Conclusions: In conclusion, we found no significant difference between in-hospital complications after propensity score matching, with the exception of deep venous thrombosis. There was no difference between length of stay but cost for L-PPM was significantly higher. In this real-world analysis, we found that the leadless PPM implantation is safe in comparison to transvenous PPM.


Hand ◽  
2018 ◽  
Vol 15 (4) ◽  
pp. 534-541 ◽  
Author(s):  
John C. Dunn ◽  
Kenneth R. Means ◽  
Sameer Desale ◽  
Aviram M. Giladi

Background: There are no clearly defined guidelines from hand surgical societies regarding preoperative antibiotic prophylaxis. Many hand surgeons continue to routinely use preoperative prophylaxis with limited supporting evidence. This study aimed to determine for which scenarios surgeons give antibiotics, the reasons for administration, and whether these decisions are evidence-based. Methods: An anonymous 25-question survey was e-mailed to the 921-member American Society for Surgery of the Hand listserv. We collected demographic information; participants were asked whether they would administer antibiotics in a number of surgical scenarios and for what reasons. Respondents were broken into 3 groups based on when they said they would administer antibiotics: Group 1 (40 respondents) would give antibiotics in the case of short cases, healthy patients, without hardware; group 2 (9 respondents) would not give antibiotics in any scenario; and group 3 (129 respondents) would give antibiotics situationally. The Fisher exact test compared demographic variables, frequency of use, and indications of antibiotic prophylaxis. Results: Of the 921 recipients, 178 (19%) responded. Demographic variables did not correlate with the antibiotic use group. Operative case time >60 minutes, medical comorbidity, and pinning each increased antibiotic use. Group 1 respondents were more likely to admit that their practice was not evidence-based (74.4%) and that they gave antibiotics for medical-legal concern (75%). Twenty-two percent of respondents reported seeing a complication from routine prophylaxis, including Clostridium difficile infection. Conclusions: Antibiotics are still given unnecessarily before hand surgery, most often for medical-legal concern. Clear guidelines for preoperative antibiotic use may help reduce excessive and potentially inappropriate treatment and provide medical-legal support.


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