Stability and performance of the EnSite Precision cardiac mapping system for electrophysiology mapping and ablation procedures: results from the EnSite Precision observational study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D Lin ◽  
B Glover ◽  
J Colley ◽  
B Thibault ◽  
C.M Steinberg ◽  
...  
Keyword(s):  
Observational Study ◽  
Real World ◽  
Cardiac Electrophysiology ◽  
Median Number ◽  
System Stability ◽  
Cardiac Mapping ◽  
Average Force ◽  
Mapping System ◽  
Respiratory Change ◽  
Electrophysiology Mapping

Abstract Background The EnSite Precision™ Cardiac Mapping System is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional and sensor enabled electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and dynamic 3-D maps of cardiac chambers. Objective The EnSite Precision™ Observational Study was designed to quantify and characterize the use of the EnSite Precision™ Cardiac Mapping System for mapping and ablation of cardiac arrhythmias in a real-world environment and to evaluate procedural and subsequent clinical outcomes. Methods 1065 patients were enrolled at 38 centers in the U.S. and Canada between 2017–2018. Eligible subjects were adults undergoing a cardiac electrophysiology mapping and radiofrequency ablation procedures using the EnSite Precision™ System. Results Of 989 patients who completed the protocol, a geometry was created in 936 (94.7%). Most initial maps were created using Automap (n=545, 67.0%) or a combination of Automap and manually mapping (n=151, 18.6%). Median time to create an initial map was 9.0 min (IQR 5.0–15.0), with a median number of used mapping points per minute of 92.7 (IQR 30.0–192.0). During ablation, AutoMark was used in 817 (82.6%) of procedures. The most frequent metrics for lesion color were Impedance Drop or Impedance Drop Percent (45.5% combined), time (23.9%) and average force (14.2%). At Canadian sites where LSI was an option, it was used as the color metric in 87 (45.8%) of cases (10.6% overall). The EnSite System was stable throughout 79.7% (n=788 of 989) of procedures. Factors affecting stability were respiratory change (n=88 of 989, 8.9%), patient movement (n=73, 7.4%), CS Positional Reference dislodgement (n=32, 3.2%), and cardioversion (n=19, 1.9%). Conscious sedation was used in 189 (19.1%) of patients. Acute success was reached based on the pre-defined endpoints for the procedure in 97.4% (n=963) of cases. Conclusion In a real-world study analysis, the EnSite Precision™ mapping system was associated with a high prevalence of acute procedural success, low mapping times, and high system stability. Funding Acknowledgement Type of funding source: None

scholarly journals Trends of pulmonary fungal infections from 2013 to 2019: an AI-based real-world observational study in Guangzhou, China

2021 ◽  
Vol 10 (1) ◽  
pp. 450-460
Author(s):  
Zhengtu Li ◽  
Yongming Li ◽  
Yijun Chen ◽  
Jing Li ◽  
Shaoqiang Li ◽  
...  
Keyword(s):  
Observational Study ◽  
Real World ◽  
Fungal Infections ◽  
Pulmonary Fungal Infections

scholarly journals 1012. Efficacy, safety and tolerability of switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in HIV-1 infected virologically-suppressed older adults in a real-world setting

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S534-S535
Author(s):  
Charlotte-Paige M Rolle ◽  
Vu Nguyen ◽  
Kiran Patel ◽  
Dan Cruz ◽  
Federico Hinestrosa ◽  
...  
Keyword(s):  
Older Adults ◽  
Drug Interactions ◽  
Real World ◽  
Research Study ◽  
Panel Member ◽  
Median Number ◽  
Research Support ◽  
Review Panel ◽  
Study Investigator ◽  
Hiv 1

Abstract Background Approximately 50% of people living with HIV (PLWH) in the United States are ≥50 years old. Efforts are ongoing to identify antiretrovirals associated with fewer drug-drug interactions (DDIs) and long-term side effects in this group. Clinical trials of B/F/TAF demonstrated favorable efficacy and safety in older adults, however, data from real-word settings are needed to validate these results. Methods This retrospective analysis evaluated records from PLWH aged ≥ 50 years at the Orlando Immunology Center who were switched to B/F/TAF between 2/7/2018 and 5/31/2019. Eligible patients had baseline HIV-1 RNA< 50 copies/mL and were followed for 48 weeks post-switch. The primary endpoint was maintenance of HIV-1 RNA< 50 copies/mL at week 48. The impact of switching to B/F/TAF on DDIs, adverse events (AEs) and safety parameters were analyzed throughout the study. Results 306 patients met inclusion criteria. 62 (20%) were female, 126 (41%) were non-white, median age was 58 years (range [r] 50-81), median duration of HIV infection was 19.5 years (r 2-40), median number of chronic co-morbid conditions was 5 (r 0-20), and median number of baseline concomitant medications was 4 (r 0-23). 159 (52%) patients were switched from regimens containing ritonavir or cobicistat. The most commonly documented reason for switch was simplification (Table 1). At Week 48, 287 (94%) patients maintained an HIV-1 RNA< 50 copies/ml and 19 (6%) had an HIV-1 RNA between 50-200 copies/mL (Figure 1). 1 patient discontinued due to lack of efficacy. A total of 123 potential DDIs were identified in 104 (34%) patients taking a boosting agent or rilpivirine at baseline (Table 2). At Week 48, there was a significant median decline in total cholesterol (15.5 mg/dL, 95% confidence interval [CI]: 9.5; 21.5), LDL cholesterol (9.5 mg/dL, 95% CI: 4; 15.5) and triglycerides (20 mg/dL, 95% CI: 9.5; 32.5), and median weight increased by 2.5 pounds (95% CI: 1.5; 3.5). Treatment-related AEs occurred in 33 (11%) patients (all Grade 1-2) and led to 7 (2%) discontinuations. Table 1-Baseline demographic and clinical characteristics Table 2-Avoidance of Drug-Drug Interactions (DDIs) following switch to B/F/TAF Figure 1-Subgroup analysis of virologic outcomes at Week 48 Conclusion In this real-world cohort, switching to B/F/TAF was associated with maintenance of virologic control, improvement in lipid parameters, and avoidance of DDIs in a large proportion of patients. These data support use of B/F/TAF as a treatment option in older PLWH. Disclosures Charlotte-Paige M. Rolle, MD MPH, Gilead Sciences (Grant/Research Support, Scientific Research Study Investigator, Speaker’s Bureau)Janssen Infectious Disease (Grant/Research Support)ViiV Healthcare (Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau) Kiran Patel, PharmD, Gilead Sciences (Employee) Federico Hinestrosa, MD, AbbVie (Speaker’s Bureau)Gilead Sciences (Speaker’s Bureau)Merck (Speaker’s Bureau)Theratechnologies (Speaker’s Bureau) Edwin DeJesus, MD, Gilead Sciences (Advisor or Review Panel member)

scholarly journals Use of 3D mapping system for ablating an accessory pathway associated with coronary sinus diverticulum

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mohammad Paymard ◽  
Marc W. Deyell ◽  
Santabhanu Chakrabarti ◽  
Zachary W. Laksman ◽  
Jacob Larsen ◽  
...  
Keyword(s):  
Coronary Sinus ◽  
Accessory Pathway ◽  
Three Dimensional ◽  
Radiofrequency Energy ◽  
Cardiac Mapping ◽  
Unsuccessful Attempt ◽  
White Syndrome ◽  
Mapping System ◽  
Coronary Sinus Diverticulum ◽  
Wolff Parkinson White Syndrome

Abstract Background This is a rare and challenging case of Wolff–Parkinson–White syndrome due to a posteroseptal accessory pathway located in the coronary sinus diverticulum. It is often difficult to precisely locate this type of accessory pathway, and the ablation procedure could be associated with collateral damage to the neighbouring coronary arteries. Case Presentation The patient was a 49-year-old female with Wolff–Parkinson–White syndrome who was referred for catheter ablation. She had had a previous unsuccessful attempt at ablation and had remained symptomatic despite drug therapy. The pre-procedural cardiac computed tomography scan revealed the presence of a diverticulum in the proximal coronary sinus. Using an advanced three-dimensional cardiac mapping system, the electroanatomic map of the diverticulum was created. The accessory pathway potential was identified within the diverticulum preceding the ventricular insertion. The accessory pathway was then successfully ablated using radiofrequency energy. Conclusion We have demonstrated that the advanced three-dimensional cardiac mapping system plays a very important role in guiding clinicians in order to precisely locate and safely ablate this type of challenging accessory pathway.

The impact of anti-CGRP monoclonal antibodies in resistant migraine patients: a real-world evidence observational study

2021 ◽  
Author(s):  
Marta Torres-Ferrús ◽  
Victor J. Gallardo ◽  
Alicia Alpuente ◽  
Edoardo Caronna ◽  
Eulalia Gine-Cipres ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Observational Study ◽  
Real World ◽  
Real World Evidence ◽  
The Impact

scholarly journals Real-world effectiveness of post-trastuzumab emtansine treatment in patients with HER2-positive, unresectable and/or metastatic breast cancer: a retrospective observational study (KBCSG-TR 1917)

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Takahiro Nakayama ◽  
Tetsuhiro Yoshinami ◽  
Hiroyuki Yasojima ◽  
Nobuyoshi Kittaka ◽  
Masato Takahashi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Observational Study ◽  
Real World ◽  
Metastatic Breast ◽  
Trastuzumab Emtansine ◽  
Her2 Positive ◽  
The Real ◽  
Her2 Positive Breast Cancer ◽  
Positive Breast Cancer

Abstract Background Trastuzumab emtansine (T-DM1) is a second-line standard therapy for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. Evidence regarding post–T-DM1 treatments is currently lacking. We evaluated the effectiveness of post–T-DM1 drug therapy in patients with HER2-positive, unresectable and/or metastatic breast cancer. Methods In this multicenter, retrospective, observational study, real-world clinical data of female patients with HER2-positive breast cancer who had a history of T-DM1 treatment were consecutively collected from five sites in Japan. We investigated the effectiveness of post–T-DM1 therapy by evaluating the real-world progression-free survival (rwPFS), time to treatment failure (TTF), overall survival (OS), objective response rate (ORR), and clinical benefit rate (CBR). Tumor response was assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) guidelines. Subgroup and exploratory analyses according to background factors were also undertaken. Results Of the 205 patients who received T-DM1 treatment between 1 January 2014 and 31 December 2018, 128 were included in this study. Among the 128 patients analyzed, 105 (82%) patients received anti-HER2 therapy and 23 (18%) patients received regimens without anti-HER2 therapy. Median (95% confidence interval [CI]) rwPFS, TTF, and OS were 5.7 (4.8–6.9) months, 5.6 (4.6–6.4) months, and 22.8 (18.2–32.4) months, respectively. CBR and ORR (95% CI) were 48% (38.8–56.7) and 23% (15.1–31.4), respectively. Cox-regression analysis showed that an ECOG PS score of 0, a HER2 immunohistochemistry score of 3+, recurrent type, ≥12 month duration of T-DM1 therapy, and anti-HER2 therapy were independent variables for rwPFS. An exploratory subgroup analysis of regimens after T-DM1 showed that those with anti-HER2 therapy had a median rwPFS of 6.3 and those without anti-HER2 therapy had a median rwPFS of 4.8 months. Conclusions In the real-world setting in Japan, several post–T-DM1 regimens for patients with unresectable and/or metastatic HER2-positive breast cancer, including continuation of anti-HER2 therapy, showed some effectiveness; however, this effectiveness was insufficient. Novel therapeutic options are still needed for further improvement of PFS and OS in later treatment settings. Trial registration UMIN000038296; registered on 15 October 2019.

Sign in / Sign up

Export Citation Format

Share Document