scholarly journals Implantation technique and optimal subcutaneous defibrillator chest position: a PRAETORIAN score-based study

EP Europace ◽  
2020 ◽  
Vol 22 (12) ◽  
pp. 1822-1829 ◽  
Author(s):  
Pietro Francia ◽  
Mauro Biffi ◽  
Carmen Adduci ◽  
Luca Ottaviano ◽  
Federico Migliore ◽  
...  
Keyword(s):  
Low Risk ◽  
Implantation Technique ◽  
Icd Implantation ◽  
Clinical Trial Registration ◽  
Optimal Position ◽  
Shock Impedance ◽  
Risk Patients ◽  
65 J ◽  
Incision Technique ◽  
Risk Categories

Abstract Aims The traditional technique for subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation involves three incisions and a subcutaneous pocket. Recently, a two-incision and intermuscular (IM) technique has been adopted. The PRAETORIAN score is a chest radiograph-based tool that predicts S-ICD conversion testing. We assessed whether the S-ICD implantation technique affects optimal position of the defibrillation system according to the PRAETORIAN score. Methods and results We analysed consecutive patients undergoing S-ICD implantation. The χ2 test and regression analysis were used to determine the association between the PRAETORIAN score and implantation technique. Two hundred and thirteen patients were enrolled. The S-ICD generator was positioned in an IM pocket in 174 patients (81.7%) and the two-incision approach was adopted in 199 (93.4%). According to the PRAETORIAN score, the risk of conversion failure was classified as low in 198 patients (93.0%), intermediate in 13 (6.1%), and high in 2 (0.9%). Patients undergoing the two-incision and IM technique were more likely to have a low (<90) PRAETORIAN score than those undergoing the three-incision and subcutaneous technique (two-incision: 94.0% vs. three-incision: 78.6%; P = 0.004 and IM: 96.0% vs. subcutaneous: 79.5%; P = 0.001). Intermuscular plus two-incision technique was associated with a low-risk PRAETORIAN score (hazard ratio 3.76; 95% confidence interval 1.01–14.02; P = 0.04). Shock impedance was lower in PRAETORIAN low-risk patients than in intermediate-/high-risk categories (66 vs. 96 Ohm; P = 0.001). The PRAETORIAN score did not predict shock failure at 65 J. Conclusion In this cohort of S-ICD recipients, combining the two-incision technique and IM generator implantation yielded the lowest PRAETORIAN score values, indicating optimal defibrillation system position. Clinical trial registration http://clinicaltrials.gov/ Identifier: NCT02275637.

scholarly journals LO06: Development of practice recommendations for ED management of syncope by mixed methods

CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S8-S9
Author(s):  
V. Thiruganasambandamoorthy ◽  
M. Taljaard ◽  
N. Hudek ◽  
J. Brehaut ◽  
B. Ghaedi ◽  
...  
Keyword(s):  
High Risk ◽  
Low Risk ◽  
Cardiac Monitoring ◽  
Structured Interviews ◽  
High Risk Patients ◽  
Practice Recommendations ◽  
Medium Risk ◽  
Risk Patients ◽  
Risk Categories

Introduction: Emergency department (ED) syncope management is extremely variable. We developed practice recommendations based on the validated Canadian Syncope Risk Score (CSRS) and outpatient cardiac monitoring strategy with physician input. Methods: We used a 2-step approach. Step-1: We pooled data from the derivation and validation prospective cohort studies (with adequate sample size) conducted at 11 Canadian sites (Sep 2010 to Apr 2018). Adults with syncope were enrolled excluding those with serious outcome identified during index ED evaluation. 30-day adjudicated serious outcomes were arrhythmic (arrhythmias, unknown cause of death) and non-arrhythmic (MI, structural heart disease, pulmonary embolism, hemorrhage)]. We compared the serious outcome proportion among risk categories using Cochran-Armitage test. Step-2: We conducted semi-structured interviews using observed risk to develop and refine the recommendations. We used purposive sampling of physicians involved in syncope care at 8 sites from Jun-Dec 2019 until theme saturation was reached. Two independent raters coded interviews using an inductive approach to identify themes; discrepancies were resolved by consensus. Results: Of the 8176 patients (mean age 54, 55% female), 293 (3.6%; 95%CI 3.2-4.0%) experienced 30-day serious outcomes; 0.4% deaths, 2.5% arrhythmic, 1.1% non-arrhythmic outcomes. The serious outcome proportion significantly increased from low to high-risk categories (p < 0.001; overall 0.6% to 27.7%; arrhythmic 0.2% to 17.3%; non-arrhythmic 0.4% to 5.9% respectively). C-statistic was 0.88 (95%CI0.86–0.90). Non-arrhythmia risk per day for the first 2 days was 0.5% for medium-risk, 2% for high-risk and very low thereafter. We recruited 31 physicians (14 ED, 7 cardiologists, 10 hospitalists/internists). 80% of physicians agreed that low risk patients can be discharged without specific follow-up with inconsistencies around length of ED observation. For cardiac monitoring of medium and high-risk, 64% indicated that they don't have access; 56% currently admit high-risk patients and an additional 20% agreed to this recommendation. A deeper exploration led to following refinement: discharge without specific follow-up for low-risk, a shared decision approach for medium-risk and short course of hospitalization for high-risk patients. Conclusion: The recommendations were developed (with online calculator) based on in-depth feedback from key stakeholders to improve uptake during implementation.

P1157Defibrillation threshold with subcutaneous implantable-cardioverter defibrillator implanted using an intermuscular 2-incision approach

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
M Biffi ◽  
M Ziacchi ◽  
C Martignani ◽  
C Lavalle ◽  
A Piro ◽  
...  
Keyword(s):  
De Novo ◽  
Safety Margin ◽  
Real Life ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Implantable Cardioverter Defibrillators ◽  
Icd Implantation ◽  
Ventricular Ejection Fraction ◽  
Shock Impedance ◽  
Incision Technique

Abstract Funding Acknowledgements NO FUNDING OnBehalf Rhythm Detect Registry Background Current subcutaneous implantable cardioverter–defibrillators (S-ICD) deliver 80J, and the conversion test is usually conducted by delivering shock energy of 65 J to ensure a safety defibrillation margin of at least 15 J. However, little is known about the real safety margin in real life clinical practice. Purpose To determine the defibrillation threshold (DFT) with S-ICD and to investigate its association with clinical characteristics. Methods De novo S-ICD patients were  consecutively enrolled and DFT was evaluated using a pre-specified step-up protocol at implantation. Results 35 patients, BMI 25 ± 4 kg/m2, left ventricular ejection fraction (LVEF) 48 ± 19%, underwent S-ICD implantation. The generator was positioned in an intermuscular pocket and a 2-incision technique was applied in all patients. The mean DFT was 30 ± 10J and the DFT was &gt;30J in 7 (20%) patients. A single patient had a &gt;40J DFT. The time to shock was 11 ± 3 seconds and the shock impedance was 67 ±21 Ohm at the lowest effective energy. The DFT was comparable in patients with LVEF ≤35% (33 ± 15J) versus &gt;35% (29 ± 5J, p = 0.278), and in patients with BMI ≤25 kg/m2 (30 ± 5J) versus &gt;25kg/m2 (31 ± 14J, p = 0.864). Conclusions We observed low DFT and low shock impedance in patients who received S-ICD with an intermuscular 2-incision approach. The S-ICD defibrillation success rate at ≤30J was 80%, while 97% of patients were defibrillated at ≤ 40J. We found no difference in DFT according to the LVEF or the BMI.

Failure to achieve a satisfactory cardiac outcome after isolated coronary surgery in low-risk patients

2020 ◽  
Vol 31 (1) ◽  
pp. 9-15
Author(s):  
Antonino S Rubino ◽  
Francesco Nicolini ◽  
Tuomas Tauriainen ◽  
Till Demal ◽  
Marisa De Feo ◽  
...  
Keyword(s):  
Adverse Events ◽  
Artery Bypass ◽  
Low Risk ◽  
Hospital Death ◽  
Clinical Trial Registration ◽  
Risk Patients ◽  
Cardiac Outcome ◽  
Cardiac Operative Risk Evaluation ◽  
Technical Failures

Abstract OBJECTIVES This study aims to investigate the incidence and determinants of major early adverse events in low-risk patients undergoing isolated coronary artery bypass grafting (CABG). METHODS The multicentre E-CABG registry included 7352 consecutive patients who underwent isolated CABG from January 2015 to December 2016. Patients with an European System for Cardiac Operative Risk Evaluation (EuroSCORE) II of &lt;2% and without any major comorbidity were the subjects of the present analysis. RESULTS Out of 2397 low-risk patients, 11 (0.46%) died during the index hospitalization or within 30 days from surgery. Five deaths were cardiac related, 4 of which were secondary to technical failures. We estimated that 8 out of 11 deaths were potentially preventable. Logistic regression model identified porcelain aorta [odds ratio (OR) 34.3, 95% confidence interval (CI) 1.3–346.3] and E-CABG bleeding grades 2–3 (OR 30.2, 95% CI 8.3–112.9) as independent predictors of hospital death. CONCLUSIONS Mortality and major complications, although infrequently, do occur even in low-risk patients undergoing CABG. Identification of modifiable causes of postoperative adverse events may be useful to develop preventative strategies to improve the quality of care of patients undergoing cardiac surgery. Clinical Trial Registration NCT02319083 (https://clinicaltrials.gov/ct2/show/NCT02319083).

Effect of Prognostic Risk Classification on Temsirolimus Efficacy and Safety Outcomes in Patients with Relapsed/Refractory Mantle Cell Lymphoma

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2708-2708 ◽  
Author(s):  
Georg Hess ◽  
Lisa Kang ◽  
Pádraig J. Moran
Keyword(s):  
High Risk ◽  
Mantle Cell Lymphoma ◽  
Cell Lymphoma ◽  
Low Risk ◽  
Phase Iii ◽  
Risk Category ◽  
Mantle Cell ◽  
Risk Patients ◽  
Grade 3 ◽  
Risk Categories

Abstract Abstract 2708 Background: The simplified Mantle Cell Lymphoma International Prognostic Index (MIPI) has been shown to be a good predictor of patient survival (Blood 2008;111:558–65; Blood 2010;115:1530–1533). This post hoc study analyzed data from a randomized, phase III clinical trial investigating temsirolimus (TEM) in relapsed/refractory mantle cell lymphoma (MCL) in which TEM 175/75 (175 mg for first 3 weeks then 75 mg weekly) demonstrated significantly longer progression-free survival (PFS) vs investigator's choice of therapy (INV; 4.8 vs 1.9 months, respectively; hazard ratio [HR]=0.44; P=.0009; J Clin Oncol 2009;27:3822–9). Patients receiving TEM 175/25 (175 mg for first 3 weeks then 25 mg weekly) also had longer PFS vs INV, but this difference was not significant (3.4 vs 1.9 months; respectively; HR=0.65; P=.06). During the trial, baseline prognostic risk classification was not recorded; thus, patients were retrospectively assigned baseline prognostic scores, and outcomes were analyzed according to risk category. Methods: All patients (N=162) were classified as low, intermediate, or high risk using the simplified MIPI. The MIPI scores were based on 4 independent prognostic markers: age, Eastern Cooperative Oncology Group (ECOG) performance status, lactate dehydrogenase level, and white blood cell count. Median PFS and overall survival (OS) were calculated using Kaplan-Meier estimates, and treatment effect was assessed using log-rank statistics. P values of ≤.05 indicated significance of the treatment effect between the 2 treatment groups. As the phase III study was not powered to analyze patients according to MIPI risk categorization, statistical analyses shown are for explanatory purposes. Results: Distribution was relatively even across MIPI risk categories (55 patients low, 59 patients intermediate, 48 patients high). MIPI distributions in the 2 TEM arms were: 175/75 (n=54: 28% low, 43% intermediate, 30% high); 175/25 (n=54: 28% low, 33% intermediate, 39% high). Relative to the TEM arms, the INV arm (n=54) had a higher proportion of low-risk patients (46% low; 33% intermediate; 20% high). TEM 175/75 resulted in significant improvement in median PFS (independent assessment) vs INV in high-risk patients (P=.003) (Table); trends toward improvement were observed for intermediate-risk and low-risk patients (P=.06 in each group). By investigator assessment, TEM 175/75 improved median PFS vs INV by 7.9 months in the low-risk category (P=.0007) and by 2.8 months (P=.06) and 1.1 month (P=.001) in the intermediate-risk and high-risk categories, respectively. A trend toward longer OS was observed in the low-risk patients treated with TEM 175/75 vs INV (P=.0502). In the low-risk category, maintenance of stable disease or better response was achieved in more patients receiving TEM 175/75 (9/15 [60%]) vs INV (5/25 [20%]); objective responses were observed in 5 patients with TEM 175/75 and in no patients with INV. Patients in the low-risk category treated with TEM 175/75 received a longer duration of therapy vs INV (30.7 vs 9.0 wk, respectively). Across the duration of treatment, the average frequency of delay was once per 5.6 wk with TEM 175/75 vs once per 6.4 wk with INV. TEM was generally well tolerated. Grade 3/4 anemia, thrombocytopenia, and infection also were analyzed by patient risk category. In both the TEM 175/75 and INV groups, the selected grade 3/4 events occurred more commonly in high-risk than low-risk patients. In the low-risk category, a higher incidence of grade 3/4 thrombocytopenia and anemia was observed with TEM 175/75 vs INV. Conclusions: Retrospective risk analysis of patients according to the simplified MIPI demonstrated that TEM 175/75 was effective across patient risk categories. The greatest benefit trend was observed in low-risk patients. In this study of relapsed/refractory MCL patients, MIPI was a good predictor of survival outcome. Disclosures: Hess: Pfizer: Consultancy, Honoraria, Research Funding. Off Label Use: Torisel is licensed for treatment of relapsed and/or refractory mantle cell lymphoma and renal cell carcinoma in Europe. Torisel is licensed in the US for renal cell carcinoma. Kang:Pfizer: Employment. Moran:Pfizer: Employment.

Exploring the Validity and Operational Impact of Using Allied Health Assistants to Conduct Dysphagia Screening for Low-Risk Patients Within the Acute Hospital Setting

2020 ◽  
Vol 29 (4) ◽  
pp. 1944-1955 ◽  
Author(s):  
Maria Schwarz ◽  
Elizabeth C. Ward ◽  
Petrea Cornwell ◽  
Anne Coccetti ◽  
Pamela D'Netto ◽  
...  
Keyword(s):  
At Risk ◽  
Allied Health ◽  
Assessment Tool ◽  
Hospital Setting ◽  
Low Risk ◽  
False Negatives ◽  
Exact Agreement ◽  
Risk Patients ◽  
Impact Phase ◽  
Operational Impact

Purpose The purpose of this study was to examine (a) the agreement between allied health assistants (AHAs) and speech-language pathologists (SLPs) when completing dysphagia screening for low-risk referrals and at-risk patients under a delegation model and (b) the operational impact of this delegation model. Method All AHAs worked in the adult acute inpatient settings across three hospitals and completed training and competency evaluation prior to conducting independent screening. Screening (pass/fail) was based on results from pre-screening exclusionary questions in combination with a water swallow test and the Eating Assessment Tool. To examine the agreement of AHAs' decision making with SLPs, AHAs ( n = 7) and SLPs ( n = 8) conducted an independent, simultaneous dysphagia screening on 51 adult inpatients classified as low-risk/at-risk referrals. To examine operational impact, AHAs independently completed screening on 48 low-risk/at-risk patients, with subsequent clinical swallow evaluation conducted by an SLP with patients who failed screening. Results Exact agreement between AHAs and SLPs on overall pass/fail screening criteria for the first 51 patients was 100%. Exact agreement for the two tools was 100% for the Eating Assessment Tool and 96% for the water swallow test. In the operational impact phase ( n = 48), 58% of patients failed AHA screening, with only 10% false positives on subjective SLP assessment and nil identified false negatives. Conclusion AHAs demonstrated the ability to reliably conduct dysphagia screening on a cohort of low-risk patients, with a low rate of false negatives. Data support high level of agreement and positive operational impact of using trained AHAs to perform dysphagia screening in low-risk patients.

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