scholarly journals A leadless pacemaker in the real-world setting: Patient profile and performance over time

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
C Garweg ◽  
N Clementy ◽  
P Mondoloy ◽  
S Winter ◽  
P Bordachar ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Medtronic, Inc. OnBehalf Micra Acute Performance EMEA Investigators Background The first in-man implant of the Micra leadless pacemaker occurred in December 2013. While prior trials demonstrated a high implant success rate and favorable safety and efficacy results; whether the patient population and outcomes have changed over time is not well studied. Purpose To characterize the evolution of patient profile and outcomes for patients receiving a leadless pacemaker through the pre-market and post-market environment. Methods Patients undergoing a Micra leadless pacemaker implant attempt from the initial Micra Investigational Device Exemption [IDE] and current Micra studies (Micra post-approval registry [PAR], Micra acute performance [MAP] study) were analyzed. Patient characteristics and pericardial effusions regardless of severity were summarized. Results The 3466 patients included in the analysis underwent a Micra implant attempt and were enrolled during consecutive timeframes: patients from the Micra IDE study (n = 726) underwent a Micra implant attempt from 2013-2015, patients from the PAR (n = 1814) from 2015-2018, and patients from Micra MAP cohort (n = 926) from 2018 – 2020.  Implant success was >99.0% in all 3 studies. Median age ranged from 78 – 79 years among the 3 studies without significant difference. There were more patients requiring dialysis in the MAP cohort compared to the PAR or IDE cohorts (10.3%, 7.9%, and 3.9%, respectively; P < 0.001), but fewer patients with congestive heart failure (8.3%, 13.1%, and 18.0%; P < 0.001). Pacing indication was significantly different between the studies, with fewer patients in MAP having an indication of bradyarrhythmia associated with atrial fibrillation (AF) and more having an indication associated with atrioventricular block without AF (P < 0.001). The number of patients considered to be precluded for a transvenous pacemaker implant increased significantly from the initial IDE study to the PAR and MAP studies (6.2%, 23.9%, and 44.1%, respectively, P < 0.001).  Implant site placement was mostly apical for the IDE but shifted to mostly septal placement in the PAR and MAP (septal placement: 33.3%, 64.0%, and 79.5%, respectively). The rate of pericardial effusion regardless of severity was 1.79% (n = 13) in the IDE, 0.83% (n = 15) in the PAR, and 0.97% (n = 9) in MAP (figure). Mean pacing thresholds among MAP EMEA patients were low (0.61 ± 0.40V) at implant and remained stable through 12 months (0.62 +/- 0.41V). Conclusion Despite patient differences over time, the Micra leadless pacemaker was implanted with a high success rate and a low perforation rate, in-line with prior reports. Abstract Figure. Pericardial effusion rate by study

2020 ◽  
Vol 22 (2) ◽  
pp. 118-127
Author(s):  
Mohan Khadka ◽  
AKM Anwarul Islam ◽  
Isteaq Ahmed Shameem ◽  
ASM Shafiul Azam ◽  
Md Golam Mowla Choudhury

Background: Posterior urethral valves are the most common cause of congenital obstructive lesion in the newborns and infant male child, occurring at the distal portion of the prostatic urethra. Diathermy fulguration of valve is one of the commonest modalities which has been practiced by Pediatric Urologist since decades where success rate ranging from 50-70%. Despite high success rate, post-operative complications like hematuria, urinary tract infections, urinary incontinence, retention of urine, residual valve and urethral stricture may develop in significant number of patients. Incision of the posterior urethral valve by cold knife is one of the modalities in the recent years with insignificant complications and good outcome with success rate ranging from 70-90%. Objective: To compare the efficacy of the cold knife with the diathermy fulguration in the management of the posterior urethral valve. Materials and Methods: This study was conducted in Urology Department of Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh from 1st January 2017 till 1st September 2018. A total 48 patients, diagnosed as a case of PUV and who fulfill the selection criteria were divided randomly by simple lottery method into 2 groups consisting of 24 patients in each group. Valve ablation was performed under standard aseptic condition according to groups. Patients were followed up at 3 and 6 months of initial intervention. They were re-evaluated during the follow up with history, clinical examination and investigation findings. Their subjective outcome and objective findings were assessed and compared in between the two groups. Results: There was no significant difference in the age distribution in between the groups (p= 0.083). Within the group, all the variable parameters were significantly improved prior and after the intervention. But, in between the groups, after 6 months of intervention, there was no difference in improvement of urinary flow(p=0.695). Incontinence of urine was not significant (p=1.000). The drop of mean serum creatinine level was not significant (p=0.530). Decrease in Mean PVR was not significant (p=0.684). Maximum flow rate was not significantly improved (p= 0.255). Peri catheter bleeding and residual valve were not significant. Stricture urethra was not found in any patient in both groups. Conclusion: Comparing the findings of the present study, it can be concluded that cold knife incision is equally effective in comparison to diathermy fulguration in the management of posterior urethral valve. Bangladesh Journal of Urology, Vol. 22, No. 2, July 2019 p.118-127


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Konstantinou ◽  
S Bordignon ◽  
T Tohoku ◽  
S Chen ◽  
F Bologna ◽  
...  

Abstract Introduction Direct oral anticoagulation (DOAC) therapy represents the standard of care in patients with atrial fibrillation (AF) and increased stroke risk. In a real world setting withholding DOAC medication before elective AF ablation is considered to reduce procedural bleeding risks. The aim of this study was to determine the individual DOAC level prior to the ablation procedure, to identify predisposing factors affecting traceable DOAC levels and to screen for associated severe adverse events. Methods Between September 2016 and March 2019 blood samples were obtained from patients on DOAC before an elective AF ablation. Per institutional standard all patients have been instructed to pause DOAC medication prior ablation for one or two doses depending on the patient profile and type of medication. The time interval between ablation and last DOAC intake was calculated in hours. Patient characteristics, procedural data and in-hospital complications were noted from all patients. Results A total of 1000 patients (60% male, age: 68y, GFR 83.25: BMI: 28, CHADSVASC score 3) undergoing AF ablation were included. Two groups were defined. Group A (n=416, 41.6%): patients treated with “single pill” DOAC (Rivaroxaban (n=288, 28.8%) and Edoxaban (n=128, 12.8%)). Group B (n=584, 58.4%): patients treated with twice a day DOAC (Apixaban (n=505, 50.5%) and Dabigatran (n=79, 7.9%)). The only difference in patient characteristics was an increased prior bleeding history in group B. The DOAC pause was significantly longer in group A (mean 40h) compared to group B (mean 32h), p=0.026. In a total of 217 patients (21.7%) DOAC levels where traceable prior to AF ablation. Traceable DOAC levels were significantly more common in group B (n=144/584, 24.7%) compared to group A (n=73/416, 17.5%). Adverse events occurred in 5.7% of patients (0.4% stroke, 0.3% tamponade, 2.5% hematoma, 1.9% AV-fistel, 0.7% pseudoaneurysma). T-Test analysis showed no significant difference in the occurrence of adverse events between both groups. Conclusion Despite of interrupting DOACs before an elective AF ablation therapeutic substance levels can be detected in >20% of patients. The rate of adverse events was not different between “single pill” vs. twice a day DOAC intake. Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
F.V.Y Tjong ◽  
R.E Knops ◽  
B Swackhamer ◽  
B Koop ◽  
B Soltis ◽  
...  

Abstract Background A novel modular cardiac rhythm management (mCRM) therapy approach is evaluated in this study: the performance of an anti-tachycardia pacing enabled leadless pacemaker (LP) commanded by a subcutaneous-ICD (S-ICD) via wireless, intra-body, device-device communication (DDC). Objectives To investigate long-term DDC performance of linked S-ICD to LP (mCRM System) and factors that impact DDC performance. Methods The mCRM System was implanted in 37 canine subjects: 33 with an S-ICD and an LP; 4 with an S-ICD and 2 LPs. The S-ICD was implanted using a Parsonnet pouch in the first 8 subjects. Communication thresholds were measured in three postures up to 18 months. Percent tissue encapsulation of the LP was measured at necropsy and ranged from 6% to 100% (mean: 62%). S-ICD system migration was evaluated radiographically at implant vs. at necropsy in two planes (anterior-posterior and left lateral) and evaluated 0–3 scale: none, minimal, moderate, significant. Communication thresholds were evaluated at 0 vs. 3 days using a t-test and 3 days through 18 months using a linear regression analysis. A repeated measures generalized linear model (GLM) was used to evaluate if test posture, percent tissue encapsulation of the LP, Parsonnet pouch use, or S-ICD system migration (no/ minimal migration vs. moderate/significant migration) were significant predictors of DDC performance at the subject's termination time point. Results DDC was successful for each tested posture and time point for all subjects (n=37), with 355 tests in Left Lateral (LL), 371 tests in Dorsal (D), and 355 tests in Right Lateral (RL). Follow up data are available up to 18 months for 19 subjects at the time of this abstract; additional follow-up data will be added to the analysis for presentation. Communication thresholds decreased between 0 days and 3 days (LL P<0.01, D P<0.01, RL P<0.05) and did not change significantly from 3 days through 18 months (LL P=0.90, D P=0.83, RL P=0.83). The GLM showed that there is no significant difference in communication thresholds for test posture (P=0.24 LL vs. D, P=0.24 RL vs. D), percent tissue encapsulation of the LP (P=0.63), Parsonnet pouch use (P=0.65), or S-ICD system migration (P=0.95). Conclusion Longitudinal studies demonstrate low and stable communication thresholds of a novel mCRM system over time for all three tested postures, regardless of factors such as LP encapsulation, Parsonnet pouch use, or S-ICD system migration. Device Communication Threshold Stability Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Boston Scientific


2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Masanobu Ueno ◽  
Ippei Miyagawa ◽  
Kazuhisa Nakano ◽  
Shigeru Iwata ◽  
Kentaro Hanami ◽  
...  

Abstract Background Mepolizumab (MPZ), an anti-interleukin-5 antibody, is effective for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA). However, its effectiveness has not been adequately evaluated in real-world clinical practice. In this study, we assessed the effectiveness and safety of MPZ (300 mg) for relapsing/refractory EGPA resistant to corticosteroids (CS) for 1 year in real-world settings. Methods We administered MPZ (300 mg) to 16 patients with relapsing/refractory EGPA resistant to CS (Post-MPZ). We also retrospectively collected data from the same patients for the 12 months before the administration of MPZ (Pre-MPZ). The primary endpoint was the 12-month remission rate after MPZ administration and the secondary endpoints were the Birmingham vasculitis activity score (BVAS), vasculitis damage index (VDI), eosinophil counts, changes in concomitant CS doses/concomitant immunosuppressant use, MPZ retention rate, and incidence of adverse events. The clinical course was compared between Pre-MPZ and Post-MPZ. Results The 12-month remission rate after the initiation of MPZ was 75%. No change was observed in BVAS, eosinophil count, or concomitant CS dose over time in the Pre-MPZ group, whereas all these parameters were significantly decreased over time in the Post-MPZ group. The number of patients using concomitant immunosuppressant also decreased over time in the Post-MPZ group. VDI did not increase in either group. The MPZ retention rate was 100% and only three patients (18.8%) had infections. Changes in BVAS, eosinophil count, and cumulative concomitant CS dose were significantly lower in the Post-MPZ group than in the Pre-MPZ group. There was no significant difference in the changes in VDI between the groups. Conclusion This study demonstrated that MPZ is effective and safe for EGPA. Furthermore, MPZ decreases disease activity, increases remission rate, and has a CS-sparing effect.


2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
R Tripathi ◽  
J Morales ◽  
O Ortiz ◽  
V Lee ◽  
V Capponi ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): CytoSorbents Medical Incorporation Background A hemadsorption device containing biocompatible porous polymer beads is easily incorporated into extracorporeal circuits including cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), continuous renal replacement therapy (CRRT), and hemoperfusion. This device has been shown to safely and effectively remove the P2Y12 receptor antagonist ticagrelor and the direct oral anticoagulant (DOAC) rivaroxaban during CPB in patients undergoing emergent cardiac surgery.  Importantly, drug removal was associated with significant reductions in surgical bleeding and improved clinical outcomes resulting in CE Mark approval. Apixaban, another DOAC, has gained increasing popularity given its proven efficacy and lower risk of bleeding in clinical use. However, a pressing unmet medical need exists for the mitigation of the bleeding risk encountered in patients on apixaban who require urgent or emergent surgery. Currently approved reversal agents are only indicated in the case of uncontrolled or life-threatening bleeding, but not as preventive measures to mitigate surgical bleeding. Purpose To demonstrate the ability of the extracorporeal hemoadsorption device to remove apixaban from whole blood. Methods The hemoadsorption device was evaluated for removal of apixaban in an in vitro benchtop model using bovine whole blood. The 4L of blood were continuously circulated through a 300 mL porous polymer device over 6 hours at a flow rate of 300 mL/min to evaluate the drug removal kinetics of apixaban. Starting apixaban concentration of 300ng/mL was utilized in the model to reflect standard therapeutic levels. Plasma levels of apixaban over time were measured using liquid chromatography with tandem mass spectrometry (LC-MS-MS). A control setup utilized an identical flow circuit, minus the hemoadsorption device. Results Mean plasma concentration of apixaban was reduced to ∼9.1 ng/mL (equivalent to ∼96.3% removal) over the first 60 min of hemoperfusion with the device. Specifically, mean percent remaining plasma concentration of apixaban following device treatment was 42.2%, 18.6%, 8% and 3.7% after 15, 30, 45 and 60 min of therapy, respectively. Overall, ∼99.7% blood concentration of apixaban was removed over the total 6 h. Drug concentrations remained unchanged in the control circuit, with a statistically significant difference between the control and treatment groups at all time points except 0 h (p < 0.01). Conclusion Apixaban is efficiently removed with hemoadsorption using porous polymer device technology. Drug concentrations were reduced >96% after 60 min. Similarly, efficient benchtop removal utilizing the same technology was observed for ticagrelor and rivaroxaban, and subsequently translated into significant clinical benefit in patients requiring emergent cardiac surgery. The results of the current study hold significant promise for the future clinical applicability of apixaban removal. Abstract Figure. Percent of remaining apixaban over time


Author(s):  
James C Doidge ◽  
Paul R Mouncey ◽  
Karen Thomas ◽  
Doug W Gould ◽  
Paloma Ferrando-Vivas ◽  
...  

Aim: To report changes in admission rates, patient characteristics, processes of care and outcomes for all patients with COVID-19 admitted to intensive care units (ICUs) in England, Wales and Northern Ireland. Methods: Population cohort of all 10,287 patients with COVID-19 appearing in the Case Mix Programme national clinical audit from 1 February to 2 July, 2020. Analyses were stratified by time period (pre-peak, peak, post-peak) and geographical region, and multivariable regressions were used to estimate differences in 28-day mortality, adjusting for variation in patient characteristics over time. Results: Admissions to ICU peaked on 1 April, nine days after commencement of “lockdown”, and occurred simultaneously across regions. The number of patients in ICU peaked ten days later. Compared with patients admitted during the pre- and post-peak periods, patients admitted during the peak were younger and had lower levels of prior dependency but more severe respiratory and renal dysfunction. Use of invasive ventilation and renal replacement reduced over time. Twenty-eight-day mortality reduced from 43.5% (95% CI 41.6% to 45.5%) pre-peak to 34.3% (95% CI 32.3% to 36.2%) post-peak; a difference of −8.8% (95% CI: −5.2%, −12.3%) after adjusting for patient characteristics. London experienced the highest admission rate and had higher mortality during the peak period but a greater reduction in post-peak mortality. Conclusion: Observed trends suggest opposing effects of ICU strain and clinical learning. Further investigation is needed to identify modifiable system factors that could alleviate strain in future epidemics and changes in clinical practice that contributed to improved patient outcomes.


2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Daniel S Olsson ◽  
Daniel Granfeldt ◽  
Åse Björstad ◽  
Antonio Ribeiro-Oliveira ◽  
Anna Jonasson ◽  
...  

Abstract Background Acromegaly is a complex disease, primarily treated with pituitary surgery or long-acting somatostatin analogues (LA-SSA). Few studies have examined real-world use of LA-SSA. This analysis evaluated LA-SSA treatment patterns in Sweden for patients with acromegaly. Methods Data were obtained from nationwide health care registers. Patients were included if they had diagnosis codes for acromegaly and neoplasm of the pituitary gland between Jul 1, 2005 and Dec 31, 2017, and at least one purchase of LA-SSA (lanreotide [LAN] 60, 90, or 120 mg, or octreotide [OCT] 10, 20, or 30 mg). Cox regression models were used for analyses of persistence and switching. Results The analysis included 176 pts treated with LA-SSA in 2005-2017. The cohort was subgrouped on year of initiation of LA-SSA (2005-2011, n=90, 51%; 2012-2017, n=86, 49%). In the first period, 36 pts (40%) initiated LAN while 54 pts (60%) initiated OCT while in the later period, 44 pts (51%) initiated LAN and 42 pts (49%) initiated OCT (p=0.17). No patients initiated pasireotide. Patient characteristics were similar between LAN and OCT initiators, but history of pituitary surgery was more common for LAN as compared to OCT (LAN 62%; OCT 46%, p<0.05). Similar results were seen for visual-field defects (LAN 20%, OCT 8%, p<0.05). Median (95%CI) follow-up was not significantly different [LAN 5.3 (3.7; 6.0) yrs.; OCT 6.4 (4.5; 7.6)]. The mean (95%CI) dose interval was not significantly different, 30.5 (28.7; 32.6) days for LAN vs 29.5 (28.5; 30.3) days for OCT. The median (95%CI) duration of 1st-line LA-SSA treatment was 14.4 (10.8; 21.6) months for LAN and 12.0 (7.2; 19.2) months for OCT. Fifty-one pts (64%) discontinued 1st-line LAN while 70 pts (73%) discontinued 1st-line OCT (hazard ratio (HR) LAN vs. OCT 0.80; 95% CI: 0.56-1.15). Due to the use of register data, the reason for therapy change could not be determined. Eight pts (10%) switched LAN to OCT while 29 pts (30%) switched OCT to LAN. Patients initiated on OCT were more likely to switch to LAN than the other way around (HR for switch for 1st-line LAN vs. OCT 0.33; 95% CI 0.15-0.72). Among patients who switched OCT to LAN, 67% of LAN dispensing was 120 mg, 21% 90 mg, and 12% 60 mg. Among patients who switch LAN to OCT, 84% of OCT dispensing was 30 mg, and 16% 20 mg. Conclusions There was no significant difference in the number of patients initiated on LAN or OCT despite the later introduction of LAN in Sweden. Patient characteristics were similar but LAN initiators were more likely to have undergone surgery and be diagnosed with visual field defects which could indicate that physicians initiate LAN in patients with more aggressive disease. Extended dose intervals with LAN (dosing every 6-8 w) do not seem to be commonly used in Sweden. In comparison to OCT, patients initiated on LAN were significantly less likely to change LA-SSA therapy.


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
KTN Breeman ◽  
MC Burke ◽  
A Shuros ◽  
B Soltis ◽  
A Brisben ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Boston Scientific and Abbott Background Leadless pacemaker (LP) fixation mechanism exposure (FE) by penetration of the epicardial surface has been described. Previously reported animal model studies showed FE for 7/10 Micra LPs, versus 4/10 CapSureFix Novus RV pacing leads (both Medtronic). However, it is unknown whether FE causes pericardial effusion or pericarditis or does not have clinical significance. Purpose To determine the incidence of FE of a novel LP in a chronic animal model and its association with acute or chronic pericardial effusion. Methods  Canine subjects were implanted with novel LPs (Boston Scientific) in an ongoing study. Acute pericardial effusion was assessed by post-procedural transthoracic echocardiography (TTE). Chronic pericardial effusion was assessed by TTE 90 days after implantation and post-mortem assessed pericardial fluid colour (PFC) and volume (PFV). FE was assessed visually at necropsy. Mann-Whitney U tests and chi-squared tests were used to determine whether greater PFV, more haemorrhagic PFC or LP implantation location differed significantly between subjects with and without FE. Results  Results to date are reported. Canine subjects (n = 71) were chronically implanted with LPs. Due to 14 in-vivo retrievals, data is shown of 57 subjects with LPs in situ at necropsy. Pre-deployment radiocontrast injection confirmed LP position (RV apex n = 41; RV apicoseptal n = 16), and mechanical stability and electrical testing confirmed adequate talon fixation after deployment. Necropsy after median 94 days (IQR 91-540) demonstrated FE in 11 cases (19%) (figure). No acute nor chronic pericardial effusion was seen on TTE. Mean PFV for animals with and without FE was 1.8 and 1.6 cc, respectively. FE did not show an association with PFV or colour (p= 0.53 and p = 0.83, respectively). For two animals, PFV and PFC are not available; FE was not observed in either of these cases. LP implantation location was not associated with incidence of FE (p = 1.00). Conclusion  Fixation mechanism exposure by the talons of a novel leadless pacemaker was observed in 19% of animals implanted and was not associated with acute or chronic pericardial effusion. Abstract Figure 1


2019 ◽  
Vol 13 (12) ◽  
Author(s):  
Leandra Stringer ◽  
Heather Morris ◽  
Ailsa May Li Gan ◽  
Alp Sener

Introduction: The number of female medical students and physicians entering the workforce is increasing. Despite this trend, some surgical specialties are still considered male-dominant. Urology has a significant male predominance in both residency and independent practice. This male predominance could have an impact on the physician work force, mentorship opportunities for females pursuing surgery, and on medical student attraction to urology as a specialty. Research conducted in the U.S. has shown that although fewer females enter the field of urology, acceptance rates between the two genders are similar. This study aims to identify if a trend towards gender-specific acceptance into urology residency exists within Canada. We also seek to identify if gender trends in acceptance to urology differ from other surgical specialties in Canada and assess the current workforce trends in Canadian urological practice. Methods: Canadian Residency Matching Services (CARMS) data from the previous 10 years was analyzed. This data was accessed from the CARMS website.1 Logistic regression analyses were used to assess if any significant difference exists between the rates of female and male applicant acceptance into urology. These rates were then compared to the rates of female and male acceptance into surgical residency as a whole and to specific surgical specialties, such as general surgery, orthopedics, and otolaryngology. Results: Within urology applicants, there is no evidence that the success rate over time between males and females differs (p=0.47). Within surgical residency applicants, there is no evidence that the success rate over time differs between male and female applicants (p=0.84). In comparing these two rates, there is also no significant difference between rates of acceptance to urology vs. surgery in general for female applicants (p=0.45). General surgery has a higher growth of females entering into the specialty compared to urology (p=0.026). Conversely, otolaryngology (p=0.123) and orthopedics (p=0.163) did not show a significant difference in the rates of female acceptance as compared to males over time. Our small sample size of 451 applicants over the 10-year time span (122 female, 329 male) could represent a limitation, however, we did ensure to analyze a 10-year sample to attempt to get an accurate representation of any trends. Conclusions: Our data identifies that there is no significant trend toward male acceptance into urology over female applicants. There is no significant difference related to female acceptance specifically into urology or any difference between rates of females accepted into urology as compared to all other surgical subspecialties combined.


2016 ◽  
Vol 10 (1-2) ◽  
pp. 12 ◽  
Author(s):  
Tadeusz J. Kroczak ◽  
Kamaljot Singh Kaler ◽  
Premal Patel ◽  
Turki Al-Essawi

Introduction: Distal ureteroscopy for stone extraction is a common procedure that is generally performed with spinal or general anesthesia. We retrospectively reviewed all distal ureteroscopy performed for ureteric stone extraction with conscious sedation at our institution over a 10-year period to determine its efficacy and safety.Methods: A retrospective chart review was performed of all distal ureteroscopy performed for calculus removal from 2004 to 2014. Patient characteristics, analgesic requirement, tolerability, procedure time, stone size and composition, method of stone extraction, success rate, and complications were collected.Results: Between 2004 and 2014, 314 procedures were performed. Mean age was 53.74 years, with 160 males and 154 females. A success rate of 97% and 10 (3.2%) complications were reported. Mean analgesic requirement was 189 μg of fentanyl (range: 50‒400) and 2.79 mg of midazolam (range: 0‒8). A total of 263 patients (83.7%) tolerated the procedure well, with only seven (2.2%) having poor tolerability. When comparing females to males, females were found to require less fentanyl (p=0.0001) and midazolam (p=0.0001). When calculi >5 mm were compared to those <5 mm, there was no statistically significant difference in success rate, procedure time, analgesic requirement, tolerability, or complications.Conclusion: Distal ureteroscopy with conscious sedation is safe and efficacious. To our knowledge, this is the first report demonstrating stones >5 mm can be safely and effectively treated with conscious sedation during this procedure. The context of our findings must be understood within the limitations of our retrospective analysis.


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