Abstract 15215: Pro-pace: Prospective Randomized Trial of Skin Closure for Pacemaker Implant

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Jaber Abboud ◽  
Celine Guenther ◽  
Andreas Boehmer ◽  
Bernhard M Kaess ◽  
Joachim R Ehrlich
Keyword(s):  
Randomized Study ◽  
Pacemaker Implantation ◽  
Standard Technique ◽  
Skin Closure ◽  
Subcuticular Suture ◽  
Cosmetic Results ◽  
Clinical Endpoints ◽  
Primary Endpoints ◽  
Secondary Endpoints ◽  
Scar Width

Introduction: Pacemaker implantation is a standard technique with largely traditional knowledge and has been performed for over 50 years. Despite its huge distribution, there are hardly any randomized trials regarding technical aspects such as material of skin closure. Hypothesis: The aim was to compare if resorbable subcuticular suture skin is superior in terms of clinical or cosmetic endpoints vs. non-resorbable suture. Methods: We performed a prospective randomized comparison of non-resorbable subcuticular suture to suture with resorbable material for pacemaker implantation with indications according to current guidelines. All consecutive patients undergoing placement of pacemakers were eligible. Follow-up was 1 year. Scars were observed at day 1, week 6 and 1 year after surgery. Clinically relevant primary endpoints were: bleeding, infection or revision. Secondary endpoints recorded at day 1 were: local hematoma formation > 10cm diameter, wound width, insufficient skin closure. Secondary endpoints at 6 weeks and 1 year: scar width, pathological scarring with kelloid, insufficient skin closure. Cosmetic results were assessed using “ P atient and O bserver S car A ssessment score (POSA)“. Results: We included 115 pts. (77 male) and performed non-resorbable skin closure in 50 cases. There were no differences in clinical characteristics between patient groups. At 1 day after implantation was no difference between regarding clinical or cosmetic endpoints (Scar width P=0.43, POSA P=0.44). At 6 weeks and 1 year post implantation, there were similarly no differences in clinical or cosmetic endpoints between both groups (Scar width P=0.54, POSA P=0.45, figure). No relevant clinical endpoints (bleeding, infection, revision) were associated to either technique of skin closure. Conclusions: Based on the present prospective randomized study, suture material does not influence clinical or cosmetic results of pacemaker implantation.

A randomized study evaluating tailoring of advanced/metastatic colorectal cancer (mCRC) therapy using circulating cell-free tumor DNA (ctDNA) (TACT-D).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. TPS277-TPS277
Author(s):  
Kanwal Pratap Singh Raghav ◽  
Xin Shelley Wang ◽  
Lianchun Xiao ◽  
Arvind Dasari ◽  
Van K. Morris ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Radiographic Progression ◽  
Randomized Study ◽  
Standard Of Care ◽  
Cancer Center ◽  
Clinical Events ◽  
Primary Endpoints ◽  
Patient Reported ◽  
Secondary Endpoints ◽  
Md Anderson

TPS277 Background: Identifying non-responders to expensive salvage therapies with modest benefits and substantial treatment related adverse events (TRAEs) (e.g. regorafenib/TAS102 in mCRC) is necessary to maximize benefits and limit toxicities. Serial ctDNA sequencing is reliable for tracking tumor dynamics and appears to predict resistance to therapy earlier than radiographic progression. Methods: TACT-D is a randomized study (N = 100) to validate the ability of changes in ctDNA (ΔctDNA) to predict resistance early and in limiting toxicities. We hypothesize that increase in ctDNA (measured by variant allele fraction) at 2 weeks (wk) into treatment can predict resistance earlier than standard radiographic means [at 8-12 wk] and detecting resistance early can enable prompt change in therapy resulting in reduction of TRAEs. Pts with mCRC eligible for either regorafenib/TAS102 are randomized 2:1 to either standard of care (SOC) or ctDNA arm. On SOC arm, treatment is given as per current paradigm i.e. for 8 wk and then restaging. On ctDNA arm, decision to continue therapy is based on ctDNA change between baseline and 2 weeks [ΔctDNA = ctDNA (C1D15 – C1D1)]. Increase in ctDNA triggers early radiographic staging (4 wk). Treatment is continued for disease stability/regression and discontinued for progression. Study has 2 co-primary endpoints: 1) Association of Δ ctDNA and radiographic progression [62 pts on SOC arm, have 94% power (2-sided α 0.05) to detect difference of 95% vs. 58% in progressive disease between pts with increase vs decrease in ctDNA] and 2) Compare proportion of pts experiencing TRAEs within 4 months between study arms [67 in SOC arm and 33 in ctDNA arm have 82% power (2-sided α 0.05) to detect a 30% decrease in toxicity]. Key secondary endpoints include: patient-reported outcomes (MD Anderson Symptom Inventory and PRO-CTCAE), OS, clinical events of special interest (hospitalizations/ER visits/medical interventions such as blood transfusions/IV hydration), clinical trial referral and cost effectiveness. Study is now actively accruing pts (NCT03844620). Funding: MD Anderson Cancer Center, Houston, TX & Guardant Health Inc., Redwood City, CA. Clinical trial information: NCT03844620.

scholarly journals Evaluation of three methods of suture for skin closure in total knee arthroplasty: a randomized trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rodrigo Barreiros Vieira ◽  
Gustavo Waldolato ◽  
João Sequeira Fernandes ◽  
Thiago Gontijo de Carvalho ◽  
Pedro Augusto Maciel Moreira ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Pain Intensity ◽  
Knee Arthroplasty ◽  
Randomized Study ◽  
Skin Closure ◽  
Absorbable Suture ◽  
Continuous Suture ◽  
Subcuticular Suture ◽  
Aesthetic Result ◽  
Total Knee

Abstract Background There are several studies comparing techniques and different materials, yet the results are not unanimous. We compared three methods of skin closure in total knee arthroplasty (TKA), including suture with single stitches and unabsorbable MonoNylon®, as well as continuous subcuticular suture with Monocryl® or barbed Stratafix® absorbable suture. Methods A prospective, randomized study was conducted with 63 patients undergoing TKA between March 2016 and December 2016. Patients were divided into three groups: traditional suture MonoNylon® (n 22), subcuticular continuous suture with Monocryl® (n 20), and another barbed with Stratafix® (n 21). The closure time, length of wire used, pain intensity, possible complications, and cosmeses were evaluated. Results Subcuticular continuous suture using Monocryl® was superior to traditional suture using MonoNylon® as less thread was used (p 0.01) and a better cosmetic effect was achieved (p < 0.01), which was equal to Stratafix® aspects analyzed (p > 0.05). Complications were observed mostly in patients who used Stratafix®. Conclusions This study concluded that the subcuticular suture with absorbable monofilament Monocryl® proved to be advantageous compared to the others because it presented results equal to the barbed Stratafix®, however with fewer complications. Furthermore, Monocryl® was shown to be equal or superior to traditional MonoNylon® suture regarding in relation pain intensity, aesthetic result, and effective cost. Trial registration WHO ICTRP identifier RBR78dh5d. Retrospectively registered: 07/29/2020.

scholarly journals A study of skin closure of surgical wound by subcuticular sutures with polyglactin 910 fast (rapide vicryl) in planned surgery

2018 ◽  
Vol 6 (10) ◽  
pp. 3370
Author(s):  
Ashwinkumar S. Gadhvi ◽  
Dhavalkumar A. Bhimani ◽  
Udit I. Gadhvi ◽  
Darshil K. Rajgor
Keyword(s):  
Wound Closure ◽  
Cost Effective ◽  
The Body ◽  
Cosmetic Result ◽  
Skin Closure ◽  
Absorbable Suture ◽  
Surgical Wound ◽  
Subcuticular Suture ◽  
Cosmetic Results ◽  
Minimal Scarring

Background: The skin is the largest and among the most complex organs of the body. Although the skin functions simply as a protective barrier to interface with our environment, its structure and physiology are complex. Suturing is commonly used today as a mean by which wounds are closed to prevent infection and fasten healing with minimal scarring. Cosmetic results of healed wound are also important and as awareness is increasing among general population, they are more concerned with cosmetic scar. Various techniques are developed to give cosmetically better scar, like subcuticular suture, adhesive tapes, staplers, etc.Methods: Study was randomized, prospective, observational and longitudinal including 100 patients, selected according to inclusion criteria.Results: Cosmetic result of the study were good; 87% patients were having good to excellent cosmetic results. And 13% patients were having scar which was cosmetically not good (scar was either hypertrophied or thickened). complication was not significant (only 3% having on post-operative day 5).Conclusions: Surgical wound closure with subcuticular suture with absorbable suture material gives excellent cosmetic results, cheaper and cost-effective compare to other technique of wound closure having similar cosmetic result. As the removal of suture is not required, no follow up visit needed, and it saves the extra time and expenditure of patient.

Activity Tracking After Surgery: Does It Correlate With Postoperative Complications?

2021 ◽  
pp. 000313482098881
Author(s):  
Yehonatan Nevo ◽  
Tali Shaltiel ◽  
Naama Constantini ◽  
Danny Rosin ◽  
Mordechai Gutman ◽  
...  
Keyword(s):  
Postoperative Complications ◽  
Enhanced Recovery ◽  
Length Of Hospital Stay ◽  
Inverse Correlation ◽  
Complication Rates ◽  
Activity Tracking ◽  
Primary Endpoints ◽  
Specific Complication ◽  
Secondary Endpoints ◽  
Enhanced Recovery Programs

Background Postoperative ambulation is an important tenet in enhanced recovery programs. We quantitatively assessed the correlation of decreased postoperative ambulation with postoperative complications and delays in gastrointestinal function. Methods Patients undergoing major abdominal surgery were fitted with digital ankle pedometers yielding continuous measurements of their ambulation. Primary endpoints were the overall and system-specific complication rates, with secondary endpoints being the time to first passage of flatus and stool, the length of hospital stay, and the rate of readmission. Results 100 patients were enrolled. We found a significant, independent inverse correlation between the number of steps on the first and second postoperative days (POD1/2) and the incidence of complications as well as the recovery of GI function and the likelihood of readmission ( P < .05). POD2 step count was an independent risk factor for severe complications ( P = .026). Discussion Digitally quantified ambulation data may be a prognostic biomarker for the likelihood of severe postoperative complications.

scholarly journals Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study

Cephalalgia ◽  
2021 ◽  
Vol 41 (3) ◽  
pp. 294-304 ◽  
Author(s):  
Messoud Ashina ◽  
Uwe Reuter ◽  
Timothy Smith ◽  
Judith Krikke-Workel ◽  
Suzanne R Klise ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Study Drug ◽  
Statistical Testing ◽  
Control Group ◽  
Double Blind ◽  
Treatment Groups ◽  
Primary Endpoints ◽  
Registration Number ◽  
Secondary Endpoints ◽  
Common Teaes

Background We present findings from the multicenter, double-blind Phase 3 study, CENTURION. This study was designed to assess the efficacy of and consistency of response to lasmiditan in the acute treatment of migraine across four attacks. Methods Patients were randomized 1:1:1 to one of three treatment groups – lasmiditan 200 mg; lasmiditan 100 mg; or a control group that received placebo for three attacks and lasmiditan 50 mg for either the third or fourth attack. The primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in ≥2/3 attacks. Secondary endpoints included pain relief, sustained pain freedom and disability freedom. Statistical testing used a logistic regression model and graphical methodology to control for multiplicity. Results Overall, 1471 patients treated ≥1 migraine attack with the study drug. Both primary endpoints were met for lasmiditan 100 mg and 200 mg ( p < 0.001). All gated secondary endpoints were met. The incidence of treatment-emergent adverse events (TEAEs) was highest during the first attack. The most common TEAEs with lasmiditan were dizziness, paresthesia, fatigue, and nausea; these were generally mild or moderate in severity. Conclusions These results confirm the early and sustained efficacy of lasmiditan 100 mg and 200 mg and demonstrate consistency of response across multiple attacks. Trial Registration Number: NCT03670810

scholarly journals SARS-COV-2 colonizes coronary thrombus and impairs heart microcirculation bed in asymptomatic SARS-CoV-2 positive subjects with acute myocardial infarction

Critical Care ◽  
2021 ◽  
Vol 25 (1) ◽  
Author(s):  
Raffaele Marfella ◽  
Pasquale Paolisso ◽  
Celestino Sardu ◽  
Luciana Palomba ◽  
Nunzia D’Onofrio ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Viral Load ◽  
Coronary Intervention ◽  
Cardiovascular Death ◽  
Left Ventricular ◽  
Major Adverse Cardiovascular Events ◽  
Grade 5 ◽  
Primary Endpoints ◽  
Load Effects ◽  
Secondary Endpoints

Abstract Background The viral load of asymptomatic SAR-COV-2 positive (ASAP) persons has been equal to that of symptomatic patients. On the other hand, there are no reports of ST-elevation myocardial infarction (STEMI) outcomes in ASAP patients. Therefore, we evaluated thrombus burden and thrombus viral load and their impact on microvascular bed perfusion in the infarct area (myocardial blush grade, MBG) in ASAP compared to SARS-COV-2 negative (SANE) STEMI patients. Methods This was an observational study of 46 ASAP, and 130 SANE patients admitted with confirmed STEMI treated with primary percutaneous coronary intervention and thrombus aspiration. The primary endpoints were thrombus dimension + thrombus viral load effects on MBG after PPCI. The secondary endpoints during hospitalization were major adverse cardiovascular events (MACEs). MACEs are defined as a composite of cardiovascular death, nonfatal acute AMI, and heart failure during hospitalization. Results In the study population, ASAP vs. SANE showed a significant greater use of GP IIb/IIIa inhibitors and of heparin (p < 0.05), and a higher thrombus grade 5 and thrombus dimensions (p < 0.05). Interestingly, ASAP vs. SANE patients had lower MBG and left ventricular function (p < 0.001), and 39 (84.9%) of ASAP patients had thrombus specimens positive for SARS-COV-2. After PPCI, a MBG 2–3 was present in only 26.1% of ASAP vs. 97.7% of SANE STEMI patients (p < 0.001). Notably, death and nonfatal AMI were higher in ASAP vs. SANE patients (p < 0.05). Finally, in ASAP STEMI patients the thrombus viral load was a significant determinant of thrombus dimension independently of risk factors (p < 0.005). Thus, multiple logistic regression analyses evidenced that thrombus SARS-CoV-2 infection and dimension were significant predictors of poorer MBG in STEMI patients. Intriguingly, in ASAP patients the female vs. male had higher thrombus viral load (15.53 ± 4.5 vs. 30.25 ± 5.51 CT; p < 0.001), and thrombus dimension (4.62 ± 0.44 vs 4.00 ± 1.28 mm2; p < 0.001). ASAP vs. SANE patients had a significantly lower in-hospital survival for MACE following PPCI (p < 0.001). Conclusions In ASAP patients presenting with STEMI, there is strong evidence towards higher thrombus viral load, dimension, and poorer MBG. These data support the need to reconsider ASAP status as a risk factor that may worsen STEMI outcomes.

scholarly journals McGrath Video Laryngoscope May Take a Longer Intubation Time Than Macintosh Laryngoscope

2015 ◽  
Vol 2015 ◽  
pp. 1-4
Author(s):  
Prerana N. Shah ◽  
Kaveri Das
Keyword(s):  
Randomized Study ◽  
Macintosh Laryngoscope ◽  
Total Duration ◽  
Video Laryngoscope ◽  
Intubation Time ◽  
Laryngoscopic View ◽  
Lehane Grade ◽  
Secondary Endpoints ◽  
Grade Ii ◽  
Grade Iii

Background. Video laryngoscopes provide better view and can improve ease of intubation compared with standard laryngoscopes. Methods. A prospective randomized study was done on 60 patients, 18 to 65 years old, comparing McGrath video laryngoscope and Macintosh laryngoscope. The aim was to compare the ease, efficacy, and usability of them during routine airway management. The primary endpoint was duration of intubation and the secondary endpoints were Cormack and Lehane grade of laryngoscopic view, number of intubation attempts, and incidence of complications. Results. There was an increase in total duration of intubation with McGrath video laryngoscope with 42.9 ± 19.5 seconds compared to Macintosh laryngoscope with 17.9 ± 4.6 seconds. In Macintosh group, 73.3% had grade I, 20% had grade II, and 6.7% had grade III Cormack Lehane view, while in McGrath group, 83.3% had grade I, 13.3% had grade II, and 3.3% had grade III. In McGrath group, 6 patients (20%) required more than 120 seconds to get intubated and only 73.3% were intubated in 1 attempt, while patients in Macintosh group had 100% successful intubation in 1 attempt. Pharyngeal trauma was seen with McGrath videolaryngoscopy. Conclusion. Duration of laryngoscopy, intubation, and total duration of intubation were significantly higher in McGrath group than in Macintosh group. McGrath group required a higher number of intubation attempts.

Abstract 15116: The Prognostic Value of Left Ventricular Mechanical Dyssynchrony in Patients With Idiopathic Dilated Cardiomyopathy

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Yangjie Li ◽  
Yuanwei Xu ◽  
Siqi Tang ◽  
Xiaoyue Zhou ◽  
Yucheng Chen
Keyword(s):  
Dilated Cardiomyopathy ◽  
Primary Endpoint ◽  
Prognostic Value ◽  
Mechanical Dyssynchrony ◽  
Idiopathic Dilated Cardiomyopathy ◽  
Ratio Estimate ◽  
Apical Level ◽  
Primary Endpoints ◽  
Secondary Endpoints ◽  
Cmr Imaging

Backgrounds: The mechanical dyssynchrony has been commonly observed in idiopathic dilated cardiomyopathy (DCM) patients, and several cardiac magnetic resonance (CMR) imaging techniques were used to evaluate the mechanical dyssynchrony. Standard deviation of time-to-peak (T2Psd) and uniformity ratio estimate (URE) indices are two widely used parameters to reflect the incoordinate movement of the left ventricle. However, the prognostic value of mechanical dyssynchrony in DCM patients is not clear. Methods and Results: We prospectively enrolled 402 DCM patients undergoing CMR imaging between Jun 2012 to Sep 2018. Mechanical dyssynchrony was measured as T2Psd and URE indices by CMR deformable registration algorithm (DRA) analysis. The primary endpoint was defined as all-cause mortality and heart transplantation, and the secondary endpoint was a combination of primary endpoint, aborted sudden cardiac death, and heart failure readmission. Univariate and multivariate Cox regression analyses were performed to identify the association between variables and outcome. Survival curves were obtained by Kaplan-Meier survival analysis and compared by log-rank test. During a median follow-up of 25.1 months (IQR: 16.2-41.6), there were 57 patients reached primary endpoints, and secondary endpoints occurred in 132 patients. Circumferential uniformity ratio estimate (CURE) at basal, mid and apical level, radial uniformity ratio estimate (RURE)at mid and apical level and longitudinal uniformity ratio estimate (LURE) were significantly worse in patients with primary endpoint compared to patients without primary endpoint. While no significant differences were observed regarding the T2Psd value between patients with and without primary endpoints. In multivariate analysis, CURE at apical level was independently associated with primary endpoints (HR 0.214, P=0.005) and secondary endpoints (HR 0.402, P=0.018). Furthermore, among patients with LVEF <35% or presence of LGE, those with decreased CURE at apical level (<0.917) showed a significantly higher rate of adverse outcome. Conclusion: The CURE at apical level is an independent predictor of adverse cardiac events in DCM patients. Compared with T2Psd, URE index is a better predictor of adverse events.

Procalcitonin and Interleukin-6 Levels: Are They Useful Biomarkers in Cardiac Surgery Patients?

2017 ◽  
Vol 43 (4) ◽  
pp. 290-297 ◽  
Author(s):  
Anna Clementi ◽  
Alessandra Brocca ◽  
Grazia Maria Virzì ◽  
Massimo de Cal ◽  
Davide Giavarina ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Cardiac Surgery ◽  
Interleukin 6 ◽  
Independent Predictor ◽  
Chronic Renal Disease ◽  
Kidney Injury ◽  
Renal Outcome ◽  
Primary Endpoints ◽  
Secondary Endpoints ◽  
Overall Mortality

Background/Aim: Cardiac surgery-associated acute kidney injury is an independent predictor of chronic renal disease and mortality. The scope of this study was to determine the utility of procalcitonin (PCT) and plasma interleukin-6 (IL-6) levels in predicting renal outcome and mortality in these patients. Methods: PCT and plasma IL-6 levels of 122 cardiac surgery patients were measured at 48 h after the surgical procedure. Primary endpoints were adverse renal outcome and mortality. Secondary endpoints were length of stay, bleeding, and number of transfusions. Results: PCT was found to be a better predictor of adverse renal outcome than IL-6. IL-6 seemed to be a better predictor of both 30-day and overall mortality than PCT. Neither PCT nor IL-6 levels were found to be good predictors of intensive care unit stay and bleeding. Conclusion: PCT may be considered a good predictor of adverse renal outcome in cardiac surgery patients, whereas IL-6 seems to possess a good predictive value for mortality in this population of patients.

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