Incidence Of Early Adverse Events Research Articles

Routine esophagram to detect early esophageal leakage after peroral endoscopic myotomy

Background Peroral endoscopic myotomy (POEM) is highly successful in treating patients with achalasia. The aim of this study was to evaluate the incidence of early adverse events (AEs) following POEM and to assess whether post-procedural imaging by routine esophagram prevents serious AEs due to early detection of esophageal leakage after POEM. Methods Patients who underwent POEM between August 2011 and December 2022 were included in this retrospective cohort study. Post-procedural AEs were graded according to the AGREE classification. Until July 2016 routine esophagram was routinely performed one day after POEM, afterwards this was abandoned. The number and severity of post-procedural AEs were compared between patients with and without routine esophagram after POEM. Results In total, 352 patients were included (mean age 47 years, 48.3% female). Nineteen post-procedural AEs occurred of which ten were grade I (2.8%), three grade II (0.9%), five grade IIIa (1.4%) and one grade IVa (0.3%). No difference was found in the number and severity of post-procedural AEs between patients with and without routine esophagram . In 129 patients routine esophagram was performed one day after POEM. In two patients esophageal leakage was seen after which repeat endoscopy was performed to close the incision with additional clips. After abolishing routine esophagram from the protocol, no AEs led to severe complications related to esophageal leakage. Conclusion POEM is safe with relatively low number of AEs. The benefit of routine esophagram one day after POEM is limited as it does not prevent serious complications resulting from esophageal leakage.

Incidence of Early Adverse Events After Tibial Tubercle Osteotomy.

Tibial tubercle osteotomy (TTO) is a commonly utilized surgical procedure for the treatment of patellofemoral instability. Although midterm and long-term outcomes are known, perioperative complications have not been consistently reported. To identify the incidence and predictors of adverse events in the first 90-day perioperative period after TTO. Case series; Level of evidence, 4. Patients undergoing primary TTO between January 1, 2010, and December 31, 2019, were included. Readmissions in the first 90 days after surgery were collected, and data were collected for the following variables: age, sex, smoking status, body mass index, laterality, preoperative diagnosis, presence of trochlear dysplasia, tourniquet use, TTO procedure, tibial tubercle distalization, trochleoplasty, chondral procedure, number of screws, and use of an epidural catheter. Predictors of readmission for any reason were identified using multivariable logistic regression analysis. A total of 345 TTO procedures were included in the final analysis. The incidence of readmissions for any reason was 20.6% (71/345). The most common reason for readmission was postoperative pain (26/345 [7.5%]), followed by wound complications (19/345 [5.5%]) and epidural catheter-related complications (overall: 16/345 [4.6%]; specific: 16/167 [9.6%]. The incidence of major complications was 2.0% (7/345). The number of patients with each major complication was as follows: 1 for deep vein thrombosis, 2 for pulmonary embolism, 1 for septic arthritis, 1 for tibial tubercle fracture, and 2 for loss of fixation. Female sex and smoking were associated with readmission for pain. The incidence of major complications after TTO was very low (2.0%), but 20.6% of cases required readmission, primarily for an indwelling epidural catheter (3.5%) and postoperative pain (7.5%). Concomitant soft tissue procedures and the number of screws were associated with readmission after TTO. Utilizing individualized postoperative pain management and preoperative discussions about expected pain may help to avoid readmission for pain after TTO.

A Comparison of the Clinical Outcomes of Thoracic Endovascular Repair for Acute Type B Aortic Dissection with Multichanneled and Double-Channeled Morphology

In this study, we aim to investigate the clinical features and outcomes of multichanneled aortic dissection (MCAD) and double-channeled aortic dissection (DCAD) in acute type B aortic dissection (TBAD) patients who underwent thoracic endovascular aortic repair (TEVAR).In total, 479 consecutive acute TBAD patients treated with TEVAR from April 2002 to May 2020 were retrospectively enrolled in this study. The MCAD group was defined as those of multichanneled morphology by initial computed tomography angiography (CTA) (n = 61), whereas the DCAD group was defined as those with double-channeled morphology by initial CTA (n = 418). The clinical and morphological characteristics and short-term and long-term adverse events (30-day and > 30 days) were recorded and evaluated.No significant differences were noted between the 2 groups as regards demographics, comorbidity profiles, or initial feature of CTA. The incidence of true lumen compression was found to be significantly lower in the MCAD group compared with the DCAD group (8.2% versus 20.8%, P < 0.05). During the 65.37 ± 40.06 months of follow-up, there were no statistically significant differences in terms of 30-day mortality or the incidence of early adverse events between the 2 groups. The incidence rates of 5-year cumulative freedom from all-cause mortality and 5-year cumulative freedom from AD-related mortality were not significantly different between the MCAD and DCAD groups, whereas the 5-year cumulative freedom from adverse events were lower in the MCAD group compared to DCAD group (51.1% versus 72.5%, P < 0.05). In multivariate Cox regression models, only age > 60 years, pleural effusion, branch involvement, and length of the stent were independent predictors of mortality, whereas age > 60 years, pulse, pleural effusion, true lumen compression, widest diameter of the descending aorta, branch involvement, and length of stent were independent predictors of adverse aortic events.No significant difference was noted between the MCAD and DCAD groups in the 5-year mortality following, whereas patients with MCAD were found to have significantly lower AD-related events than patients with DCAD in long-term follow-up.

Incidence of Early Adverse Events Following Covishield (ChAdOx1 nCoV-19) Vaccination: A Prospective Study.

Minor adverse event following immunizations (AEFIs) are often underreported and self-treated. This study aimed to collect information regarding any and every probable adverse event experienced by the recipient of Covishield vaccine up to 10 days following the first and second dose of vaccine. To find the incidence of minor adverse events following Covishield vaccination; draw an association between adverse events and individuals' demographic factors and comorbidities; and report new adverse events, if any. A descriptive observational study was conducted among 409 participants randomly sampled from the Vaccination Centre at a Tertiary Care Hospital, Mumbai. Participants were followed up post their first and second doses to enquire about adverse events. Most commonly reported adverse events included injection site pain, tenderness, chills, fatigue, fever, and myalgia. Females reported more adverse events compared to men (p < 0.05). Younger individuals (18-24) experienced adverse events more as compared to individuals above 40 years of age (p < 0.005). Reported adverse events were lesser after the second dose in comparison with the first dose. Few participants reported dysgeusia. Covishield vaccination has a mild AEFI profile, most commonly: injection site pain, tenderness, chills, and fatigue. It is hoped that the findings of this study will dispel anxiety around the adverse events of vaccination and reduce any persisting vaccine hesitancy. Effective communication with the population on vaccination will enable individuals to make educated and informed decisions.

Does the 45 mm Size Cutoff for Ascending Aortic Replacement Predict Better Early Outcomes in Bicuspid Aortic Valve?

The aim of this study is to test if the newly proposed 45 mm size criterion for ascending aortic replacement (AAR) in bicuspid aortic valve (BAV) patients undergoing aortic valve replacement (AVR) is predictive of improved early outcomes. Data of 306 BAV patients with an aortic diameter of ≥45 mm undergoing AVR alone or with AAR were retrospectively analyzed. Patients were divided into groups of AVR + AAR (n = 220) and AVR only (n = 86) based on if surgery was performed according to the 45 mm criterion. End point was early adverse events, including 30-day and in-hospital mortality, cardiac events, acute renal failure, stroke, and reoperation for bleeding. Cox regression was used to assess if conformance to 45 mm criterion could predict fewer early adverse events. AVR + AAR group had significantly higher postoperative left ventricular ejection fraction (LVEF) (0.59 ± 0.09 vs. 0.55 ± 0.11, p = 0.006) and longer cardiopulmonary bypass (CPB) time (128 vs. 111 minutes, p = 0.002). Early adverse events occurred in 45 patients (14.7%), which was more prevalent in the AVR-only group (22.1% vs. 11.8%, p = 0.020). Conformance to the 45 mm criterion predicted lower rate of early adverse events (hazard ratio [HR]: 0.53, 95% confidence interval [CI]: 0.28-0.98, p = 0.042). After adjustment for gender, age, AAo diameter, sinuses of Valsalva diameter, preoperative LVEF, Sievers subtypes, BAV valvulopathy, and CPB and cross-clamp times, conformance to the 45 mm size criterion still predicted lower incidence of early adverse events (HR: 0.37, 95% CI: 0.15-0.90, p = 0.028). This study shows that conformance to 45 mm size cutoff for preemptive AAR during aortic valve replacement in patients with BAV was not associated with increased risk for adverse events and may improve early surgical outcomes.

Unilateral versus Bilateral Endoscopic Nasobiliary Drainage and Subsequent Metal Stent Placement for Unresectable Malignant Hilar Obstruction: A Multicenter Randomized Controlled Trial.

(1) Background: Endoscopic management of hilar biliary obstruction is still challenging. Compared with unilateral drainage, bilateral drainage could preserve larger functional liver volume and potentially improve clinical outcomes. To evaluate the effectiveness of bilateral drainage, we conducted this multicenter randomized controlled study. (2) Methods: Patients with unresectable malignant hilar biliary obstruction were assigned to unilateral or bilateral group. At first, patients underwent endoscopic nasobiliary drainage (ENBD), and subsequently underwent self-expandable metallic stent (SEMS) deployment. Primary outcomes were the functional success rate of ENBD and time to recurrent biliary obstruction (TRBO) after SEMS deployment. (3) Results: During the study period, 38 and 39 patients were enrolled in the unilateral and bilateral groups. The functional success rate was similar in the uni- and bi-ENBD group (57% vs. 56%; p = 0.99), but the rate of additional drainage was higher in uni-ENBD group. Although TRBO and overall survival time after SEMS deployment were not different between the groups (p = 0.11 and 0.78, respectively), the incidence of early adverse events tended to be higher in the bi-SEMS group (5.3% vs. 28%; p = 0.11). (4) Conclusions: Our study failed to demonstrate the superiority of bilateral over unilateral biliary drainage in terms of functional success rate and TRBO.

Barthel Index and Outcome of Open Bypass for Critical Limb Ischemia.

Daily activity should be an important factor to consider when deciding on a treatment strategy for critical limb ischemia (CLI), and we hypothesized that there was a close relationship between activities of daily living (ADL) and prognosis. The aim of this study was to investigate the association between ADL and outcomes of open bypass for CLI.Methods and Results:A total of 226 patients undergoing infrainguinal bypass for CLI between January 2005 and December 2015 were reviewed. They were divided into 2 groups based on Barthel index (BI) at admission (pre-BI; ≥60 and <60) and compared with respect to the incidence of early adverse events and 3-year overall survival and amputation-free survival. Adverse events were more frequently observed in patients with pre-BI <60. Patients with pre-BI <60 had worse long-term outcomes. On multivariable analysis, hypoalbuminemia, end-stage renal disease, and BI at discharge <60 were significant predictors of 3-year outcomes, whereas pre-BI <60 was not a significant predictor of either outcome. It is not BI at admission, but BI at discharge that determines long-term outcome.

Influence of distal extension of false lumen on adverse aortic events after TEVAR in patients with acute type B aortic dissection.

To investigate the clinical outcomes influenced by distal extension of false lumen in acute type B aortic dissection (TBAD) patients following thoracic endovascular aortic repair (TEVAR). From April 2002 to January 2013, 264 TBAD patients treated with TEVAR were retrospectively enrolled. The IIIa group exhibited a distal false lumen above the diaphragm (n = 70), and the IIIb group exhibited a distal false lumen under the diaphragm (n = 194). The morphological characteristics and adverse events (30-day and >30 days) were recorded and evaluated. There were no significant differences between the two groups regarding the demographics, comorbidity profiles, or initial feature of computed tomography angiography. The incidence of true lumen compression and branch involvement were significantly increased in the IIIb group compared with the IIIa group (8.6% vs. 25.3%, respectively; 15.7% vs. 36.1%, respectively, both P < 0.05). The 30-day mortality rate was 1.0% (2/194) in the IIIb group, whereas the IIIa group was zero. The incidence of early adverse events, the 5-year cumulative freedom from adverse events, and the 5-year cumulative freedom from all-cause mortality rate were not significantly different between the IIIa and IIIb groups (2.9% vs. 6.7%, 81.4%, and 80.4%, and 95.7% vs. 93.8%, respectively, all P > 0.05). Log-rank tests also indicated there was no significant difference. There was no significant difference between the IIIa and IIIb groups in the 5-year morality and adverse aortic events following TEVAR. The distal extension of false lumen prior to TEVAR does not influence the long-term morality and adverse aortic events in acute TBAD.

The effect of patient sex on the incidence of early adverse effects in a population of elderly patients.

Patient sex is known to influence the response to general and regional anaesthesia and recovery after surgery. However, most studies come from analyses carried out on middle-aged patients. As most of the patients admitted to the post-anaesthesia recovery room in our institution are elderly, we took the opportunity to investigate the association between sex and incidence of early adverse events in this older population of patients after major surgery. Consecutive patients undergoing general, orthopaedic, urological and gynaecological surgery, admitted to the recovery room of our institution over a 15-month period, were retrospectively studied. The following adverse events were considered in the analysis: shivering, postoperative nausea and vomiting, hypotension and hypertensive responses, new arrhythmias requiring treatment, acute respiratory failure and desaturation. A total of 1347 patients (mean age 73.3±15.1 years, 61.4% women) were included. Women showed a higher incidence of shivering (relative difference +48%, P=0.0003), postoperative nausea and vomiting (+91%, P<0.0001), hypotension (+32%, P=0.044) and desaturation (+60%, P=0.0030) than men. The incidence of hypertensive response, arrhythmias and acute respiratory failure were not statistically significantly different. The findings of this exploratory study suggest that women have a higher risk of early postoperative adverse events even in a more elderly population.

Long-term outcome of palliative therapy for gastric outlet obstruction caused by unresectable gastric cancer in patients with good performance status: endoscopic stenting versus surgery

In patients with gastric outlet obstruction (GOO) caused by gastric cancer, choosing between self-expandable metal stent (SEMS) placement and gastrojejunostomy (GJJ) is of concern, especially in those with good performance status. To compare SEMS placement and GJJ. Retrospective study. Single tertiary referral center. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 who had GOO caused by unresectable gastric cancer. SEMS placement and GJJ. Success rate, adverse events, patency, and survival duration. Of the 113 patients in this study, 72 underwent SEMS placement and 41 underwent GJJ. The 2 groups did not differ in the technical and clinical success and incidence of early adverse events. However, the rate of late adverse events was significantly higher in the SEMS group (44.4% vs 12.2%; P < .001). The median patency duration was shorter after SEMS placement than after GJJ (125 days vs 282 days; P = .001), even after additional SEMS placement (210 days vs 282 days; P = .044). The median survival was also significantly shorter after SEMS placement than after GJJ (189 days vs 293 days; P = .003). Survival differed between treatments in patients with ECOG 0-1 (P = .006) but not in those with an ECOG performance status of 2 (P = .208). Retrospective and single-center study. GJJ is preferable to SEMS placement for the palliation of GOO caused by unresectable or metastatic gastric cancer in patients with a good performance status, especially ECOG 0-1.

Impact of Incomplete Revascularization Following OPCAB Surgery

The aim of this study was to evaluate the early and mid-term off-pump coronary artery bypass surgery (OPCAB) results in a single surgical unit, assessing the impact of completeness of revascularization. Three hundred and twelve patients underwent OPCAB between August 2000 and January 2005. In-hospital data were collected prospectively for all patients undergoing OPCAB. Complete revascularization (CR) was derived by comparing significantly stenotic vessels at cardiac catheterization with surgically grafted coronary vessels. Grafting of all the significantly stenotic coronary vessels was considered CR. In-hospital outcomes were compared between patients with CR and incomplete revascularization (IR). A multivariate analysis based on the Cox proportional hazards regression model was performed. Patients receiving IR (105 patients, 43.7%) presented a worse preoperative risk profile then those having CR (mean Euroscore 6.8 +/- 2.9 vs. 4.3 +/- 2.8, p < 0.0001). IR was not associated with a higher incidence of early adverse events. Five-year freedom from death and major adverse cardiac events (MACE) were 0.88 (0.02 SE) and 0.86 (0.03 SE), respectively. Complete revascularization was protective for mid-term unstable angina recurrence [heart rate (HR) = 0.24, 95% confidence interval (CI) 0.10 to 0.58], acute myocardial infarction (HR = 0.25, 95% CI 0.09 to 0.73), all-cause repeat revascularization (HR = 0.35, 95% CI 0.13 to 0.90), and MACE (HR = 0.2, 95% CI 0.1 to 0.5). Our study suggests that, although incomplete revascularization may not result in increased short-term morbidity and mortality, it increases the incidence of mid-term MACE.

Outcome of Kidney Transplantation From Nonheart-Beating Versus Heart-Beating Cadaveric Donors

This study aimed to assess outcomes of kidney transplants from nonheart-beating (NHB) compared with heart-beating (HB) cadaveric donors with meta-analytical techniques. A literature search was performed for studies comparing kidney transplants from NHB vs. HB cadaveric donors between 1992 and 2005. The following outcomes were evaluated: warm and cold ischemia times, primary nonfunction, delayed graft function, length of hospital stay, acute graft rejection, patient and graft survival, and post-transplant serum creatinine. Eighteen comparative studies of 114,081 patients matched the selection criteria; 1,858 received kidney from NHB and 112,223 from HB donor. Warm ischemia time was significantly longer for the NHB group by 24 min (P<0.001). Cold ischemia time was similar for the two groups (P=0.97). The incidence of primary nonfunction and delayed graft function was 2.4 times (P<0.001) and 3.6 times (P<0.001) greater, respectively, in the NHB group. Length of hospital stay was longer for the NHB group by 4.6 days (P<0.001). The 6-month, 2-year, and 5-year patient survival were similar between the two groups. The incidence of acute rejection was similar between the two groups whereas the initial graft survival advantage in favor of the HB group diminished gradually over the course of time. There was no statistically significant difference between the two groups for the recipient serum creatinine levels at 3 and 12 months after transplantation. NHB donors carry the potential of expanding the cadaveric kidney pool. Although, transplants from NHB donors are associated with a greater incidence of early adverse events, long-term outcomes appear comparable with those of transplants from HB donors.

Effect of Two Different Methods of Initiating Atomoxetine on the Adverse Event Profile of Atomoxetine

To compare the effects of two different methods for initiating atomoxetine in terms of the incidence of early adverse events. Data on atomoxetine treatment-emergent adverse events in youths, ages 6 to 18 years, were analyzed from five randomized, double-blind, placebo-controlled, acute-phase studies. Two studies involve once-daily dosing and titration to 1.2 mg/kg/day over 3 days (fast/once daily, n = 234) and three involve twice-daily dosing and titration to a dose of 1.2 mg/kg/day over at least 2 weeks (slow/twice daily, n = 213). During the first 2 weeks of treatment, fast/once daily titration patients showed higher rates of spontaneously reported adverse events than patients in the slow/twice daily titration group. This included decreased appetite (14.3% versus 8.0%, p = .036) and somnolence (14.3% versus 4.2%, p < .001). Patients in the slow/twice daily group showed higher rates of headache (7.4% versus 16.9%, p = .003). Analysis of the studies' overall acute treatment phases revealed significantly higher rates in the fast/once daily group only for somnolence. No significant differences were seen in completion rates or reasons for discontinuation. When starting atomoxetine, the risk of adverse events within the first few weeks of treatment may be lower if patients are dosed twice daily and titrated to the 1.2 mg/kg/day total daily dose over the first week.

Incidence of Early Adverse Events Surrounding Direct Current Cardioversion of Persistent Atrial Fibrillation. A Cohort Study of Practices

AimsTo establish the incidence of early adverse events surrounding direct current (DC) cardioversion of persistent atrial fibrillation in an unselected patient cohort and to describe and analyse these complications. MethodsProspective study over a three-month period (February, March and April 2000). Outcome measures included all serious adverse events during the hospitalisation for DC cardioversion. Six hundred and eighty-four DC cardioversion were performed on 659 patients. ResultsThe rate of adverse events was 4.4% including 1.3% bradycardia, 0.3% ventricular arrhythmia, 0.3% QT increase, 1% serious haemorrhages, 0.4% death and 1.2% miscellaneous adverse events. ConclusionThe perceived tolerance to DC cardioversion in atrial fibrillation should be amended with the 4.4% serious early adverse events.

THE ABILITY OF PRETRANSPLANT TEST-DOSE PHARMACOKINETIC PROFILES TO REDUCE EARLY ADVERSE EVENTS AFTER RENAL TRANSPLANTATION1, 2

Pretransplant test-dose pharmacokinetic profiles were used to determine individual cyclosporine drug bioavailability and clearance rates in renal transplant patients. Assuming a linear relation between dose and area under the concentration curve (AUC), starting i.v. and p.o. CsA doses were computed from the test-dose results. Target values were 400 ng/ml steady-state concentration (Css) during continuous intravenous infusion, and 500 ng/ml average drug concentration (Cavss = AUC/dosing interval) after oral administration, based upon measurements with the specific monoclonal antibody 3H-tracer radioimmunoassay. The outcomes after dose individualization with a 1-(n = 32), 2-(n = 38), or 3-(n = 41) hr i.v. infusion test dose and a p.o. test dose (n = 111) were compared with 228 historical control patients who received a uniform protocol of CsA i.v. at 2.5 mg/kg/day and p.o. at 14 mg/kg/day. The observed Css after i.v. CsA was within 10% of the target concentration in 73% of recipients tested with the 3-hr protocol, a significantly greater fraction than achieved with either the uniform dose (14%), or the 1-(34%) and 2-(25%) hr protocols. Patients in the 3-hr protocol group showed reduced incidences of delayed graft function, early graft loss, and rejection episodes, and a lower mean serum creatinine value, particularly at 7 but also at 30 days posttransplantation. Administration of the predicted oral dose produced a peak concentration of greater than or equal to 700 ng/ml drug absorption in 60% of recipients at 3 days, 90% at 5 days, and 98% at 7 days. The test-dose method less effectively predicted the appropriate oral CsA dose to produce target Cssav and failed to reduce the 90-day rejection incidence. Despite its limitations with the more-complicated p.o. route, the test-dose method successfully predicts i.v. CsA doses, thereby reducing the incidence of early adverse events.