scholarly journals Pedicled versus skeletonized internal thoracic artery grafts: a randomized trial

2020 ◽  
pp. 021849232098349
Author(s):  
Mats Dreifaldt ◽  
Ninos Samano ◽  
Håkan Geijer ◽  
Mats Lidén ◽  
Lennart Bodin ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Internal Thoracic Artery ◽  
Controlled Trial ◽  
Artery Bypass ◽  
Conventional Angiography ◽  
Exact Test ◽  
Left Internal Thoracic Artery ◽  
The Difference ◽  
Sternal Wound Infections

Objective Concerns have been raised regarding whether skeletonization of the internal thoracic artery could damage the graft and thereby reduces its patency. The objective of this study was to compare patency rates at mid- and long-term follow-up between pedicled and skeletonized left internal thoracic artery grafts. Methods This randomized controlled trial included 109 patients undergoing coronary artery bypass surgery. The patients were assigned to receive either one pedicled or one skeletonized left internal thoracic artery graft to the left anterior descending artery. Follow-up was performed at 3 years with conventional angiography, and at 8 years with computed tomography angiography. Differences between patency rates were analyzed with Fisher’s exact test and a generalized linear model. Results The patency rates for pedicled and skeletonized left internal thoracic artery grafts were 46/48 (95.8%) versus 47/52 (90.4%), p = 0.44 at 3 years, and 40/43 (93.0%) versus 37/41 (90.2%), p = 0.71 at 8 years, respectively. The difference in patency rates for pedicled and skeletonized grafts was 5.4% (95% confidence interval: −4.2–14.5) at 3 years and 2.8% (95% confidence interval: −9.9–14.1) at 8 years. All failed grafts, except for one with a localized stenosis, were anastomosed to native coronary arteries with a stenosis less than 70%. Three patients suffered sternal wound infections (two in the pedicled group, one in the skeletonized group). Conclusions The skeletonization technique can be used without jeopardizing the patency of the left internal thoracic artery. The most important factor in graft failure was target artery stenosis below 70%.

Exclusive Bilateral Internal Thoracic Artery Grafts for Myocardial Revascularization Requiring Four Anastomoses or More: Outcomes from a Single Center Experience

2016 ◽  
Vol 65 (04) ◽  
pp. 265-271
Author(s):  
Andrea Perrotti ◽  
Enrica Dorigo ◽  
Camille Durst ◽  
Djamel Kaili ◽  
Sidney Chocron ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Internal Thoracic Artery ◽  
Artery Bypass ◽  
Univariate Analysis ◽  
Bypass Graft ◽  
Myocardial Revascularization ◽  
Wound Complication ◽  
Safe Procedure ◽  
Off Pump

Introduction Multivessel coronary artery bypass graft (CABG) with bilateral internal thoracic arteries (BITA) has only been uncommon and technically demanding. We describe our experience with BITA only CABGs requiring ≥ 4 anastomoses. Material and Methods The department's database was queried for patients undergoing isolated CABG with ≥ 4 anastomoses. The surgical technique included systematically a right internal thoracic artery (ITA) of left ITA Y graft. The multivariate model included variables with a p < 0.3 at univariate analysis. Results Between January 2006 and December 2009, 251 consecutive patients (71 ± 10 years) (on-pump: 130, off-pump: 121) had CABG with ≥ 4 anastomoses, representing 21% of total isolated CABGs for the same period; all patients received a totally arterial BITA only revascularization. Follow-up was 4.9 ± 1.6 years. Overall and cardiac cumulative survivals were 78 and 92%, respectively, at 5 years. The occurrence of any major postoperative complication was associated with overall and cardiac mortality (odds ratio [OR]: 3.6, 95% confidence interval [CI]: 1.3–9.9 and OR: 5.4, 95% CI: 1.3–21.9, respectively). Major sternal wound complication requiring surgical revision was not associated with impaired glucose control (n = 9; diabetics: 6/82, 7.3%; nondiabetics: 3/169, 1.8%, p = 0.06). Preoperative kidney failure was associated with incomplete revascularization (OR: 6.2; 95% CI: 1.2–33.5), that was unfailingly due to ungraftable right coronary artery targets. Discussion BITA only revascularization was a valuable and safe procedure, with favorable results in terms of morbidity and mortality at a 5 years' follow-up.

scholarly journals Efficacy of two-week therapy with doxycycline-based quadruple regimen versus levofloxacin concomitant regimen for helicobacter pylori infection: a prospective single-center randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Marouf Alhalabi ◽  
Mohammed Waleed Alassi ◽  
Kamal Alaa Eddin ◽  
Khaled Cheha
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Confidence Interval ◽  
Odds Ratio ◽  
Controlled Trial ◽  
Helicobacter Pylori Infection ◽  
First Line ◽  
Link Type ◽  
Syrian Population

Abstract Background Antibiotic-resistance reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, which necessitates using various treatment protocols. We used two protocols, doxycycline-based quadruple regimen and concomitant levofloxacin regimen. The aim was to assess the effectiveness of doxycycline-based quadruple regimen for treating Helicobacter Pylori infections compared with levofloxacin concomitant regimen as empirical first-line therapy based on intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population. Settings and design An open-label, randomised, parallel, superiority clinical trial. Methods We randomly assigned 78 naïve patients who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (D-group) which received (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for 2 weeks), or (L-group) which received (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test 8 weeks after completing the treatment. Results Thirty-nine patients were allocated in each group. In the D-group, 38 patients completed the follow-up, 30 patients were cured. While in the L-group, 39 completed the follow-up, 32patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the D-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454–4.146]. According to PPA, the eradication rates were 78.9%, and 82.05% for the D-group and L-group respectively. The odds ratio with 95% confidence interval was 1.219 [0.394–3.774]. We didn’t report serious adverse effects. Conclusions Levofloxacin concomitant therapy wasn’t superior to doxycycline based quadruple therapy. Further researches are required to identify the optimal first-line treatment for Helicobacter-Pylori Infection in the Syrian population. Trial registration We registered this study as a standard randomized clinical trial (Clinicaltrial.gov, identifier-NCT04348786, date:29-January-2020).

Translational delivery of Cool Little Kids to prevent child internalising problems: Randomised controlled trial

2017 ◽  
Vol 52 (2) ◽  
pp. 181-191 ◽  
Author(s):  
Jordana K Bayer ◽  
Ruth Beatson ◽  
Lesley Bretherton ◽  
Harriet Hiscock ◽  
Melissa Wake ◽  
...  
Keyword(s):  
Standard Deviation ◽  
Confidence Interval ◽  
Anxiety Disorders ◽  
Odds Ratio ◽  
Adjusted Odds Ratio ◽  
Controlled Trial ◽  
Secondary Outcomes ◽  
Randomised Controlled ◽  
Internalising Problems

Objective: To determine whether a population-delivered parenting programme assists in preventing internalising problems at school entry for preschool children at-risk with temperamental inhibition. Methods: Design: a randomised controlled trial was used. Setting: the setting was 307 preschool services across eight socioeconomically diverse government areas in Melbourne, Australia. Participants: a total of 545 parents of inhibited 4-year-old children: 498 retained at 1-year follow up. Early intervention: Cool Little Kids parenting group programme was implemented. Primary outcomes: the primary outcomes were child DSM-IV anxiety disorders (assessor blind) and internalising problems. Secondary outcomes: the secondary outcomes were parenting practices and parent mental health. Results: At 1-year follow up (mean (standard deviation) age = 5.8 (0.4) years), there was little difference in anxiety disorders between the intervention and control arms (44.2% vs 50.2%; adjusted odds ratio = 0.86, 95% confidence interval = [0.60, 1.25], p = 0.427). Internalising problems were reduced in the intervention arm (Strengths and Difficulties Questionnaire: abnormal – 24.2% vs 33.0%; adjusted odds ratio = 0.56, 95% confidence interval = [0.35, 0.89], p = 0.014; symptoms – mean (standard deviation) = 2.5 (2.0) vs 2.9 (2.2); adjusted mean difference = –0.47, 95% confidence interval = [–0.81, –0.13], p = 0.006). Parents’ participation in the intervention was modest (29.4% attended most groups, 20.5% used skills most of the time during the year). A priori interaction tests suggested that for children with anxious parents, the intervention reduced anxiety disorders and internalising symptoms after 1 year. Conclusion: Offering Cool Little Kids across the population for inhibited preschoolers does not impact population outcomes after 1 year. Effects may be emerging for inhibited children at highest risk with parent anxiety. Trial outcomes will continue into mid-childhood.

scholarly journals Increasing response rates to follow-up questionnaires in health intervention research: Randomized controlled trial of a gift card prize incentive

2017 ◽  
Vol 14 (4) ◽  
pp. 381-386 ◽  
Author(s):  
Amy J Morgan ◽  
Ronald M Rapee ◽  
Jordana K Bayer
Keyword(s):  
Randomized Controlled Trial ◽  
Confidence Interval ◽  
Odds Ratio ◽  
Response Rate ◽  
Controlled Trial ◽  
Response Rates ◽  
Health Intervention ◽  
Randomized Controlled ◽  
Gift Card

Background/aims Achieving a high response rate to follow-up questionnaires in randomized controlled trials of interventions is important for study validity. Few studies have tested the value of incentives in increasing response rates to online questionnaires in clinical trials of health interventions. This study evaluated the effect of a gift card prize-draw incentive on response rates to follow-up questionnaires within a trial of an online health intervention. Method The study was embedded in a host randomized controlled trial of an online parenting program for child anxiety. A total of 433 participants were randomly allocated to one of two groups: (1) being informed that they would enter a gift card prize-draw if they completed the final study questionnaire (24-week follow-up) and (2) not informed about the prize-draw. All participants had a 1 in 20 chance of winning an AUD50 gift card after they completed the online questionnaire. Results The odds of the informed group completing the follow-up questionnaire were significantly higher than the uninformed group, (79.6% vs 68.5%, odds ratio = 1.79, 95% confidence interval = 1.15–2.79). This response rate increase of 11.1% (95% confidence interval = 2.8–19.1) occurred in both intervention and control groups in the host randomized controlled trial. The incentive was also effective in increasing questionnaire commencement (84.6% vs 75.9%, odds ratio = 1.74, 95% confidence interval = 1.07–2.84) and reducing the delay in completing the questionnaire (19.9 vs 22.6 days, hazard ratio = 1.34, 95% confidence interval = 1.07–1.67). Conclusion This study adds to evidence for the effectiveness of incentives to increase response rates to follow-up questionnaires in health intervention trials.

Citation Advantage of Promoted Articles in a Cross-Publisher Distribution Platform: 36-month Follow-up to a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Paul Kudlow ◽  
Tashauna Brown
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Digital Tool ◽  
Randomized Controlled ◽  
Subject Areas ◽  
The Subject ◽  
The Difference ◽  
Citation Advantage

BACKGROUND There are limited evidence-based strategies that have been shown to increase the rate at which peer-reviewed articles are cited. In a previously reported randomized controlled trial we demonstrated that promotion of article links in an online cross-publisher distribution platform (TrendMD) persistently augments citation rates after 12 months, leading to a statistically significant, 50% increase in citations relative to control. OBJECTIVE To investigate if the citation advantage of promoted articles upholds after 36-months. METHODS Three thousand two hundred articles published in 64 peer-reviewed journals across eight subject areas were block randomized at the subject level to either the TrendMD group (n=1600) or the control group (n=1600) of the study. Articles were promoted in the TrendMD Network for 6 months. We compared the citation rates in both groups after 36 months. RESULTS At 36 months, we found the citation advantage endured; articles randomized to TrendMD showed a 28% increase in mean citations relative to control. The difference in mean citations at 36 months for articles randomized to TrendMD versus control was 10.52, 95% CI [3.79, 17.25] and was statistically significant (p=0.001). CONCLUSIONS To our knowledge, this is the first randomized controlled trial to demonstrate how a post-publication article promotion intervention can be used to persistently augment citations of peer-reviewed articles. TrendMD is an efficient digital tool for knowledge translation and dissemination to targeted audiences to facilitate uptake of research.

Abstract 105: Early But Not Too Early, High Intensity Physical Exercise Rehabilitation May be Beneficial: A Pilot Clinical Study

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Yanna Tong ◽  
Jamie Y Ding ◽  
Mordechai G Sadowsky ◽  
Huishan Du ◽  
Xiaokun Geng ◽  
...  
Keyword(s):  
Stroke Unit ◽  
Controlled Trial ◽  
Early Mobilization ◽  
Favorable Outcome ◽  
Initiation Time ◽  
Post Discharge ◽  
Post Stroke ◽  
Standard Medical Therapy ◽  
The Difference

Introduction: Very early mobilization (VEM) is thought to be beneficial for stroke-unit care, but many key factors, such as initiation time and intensity, have not been optimized. We attempted to determine an optimal mobilization plan with well-defined initiation time and intensity in clinical practice. Methods: We conducted a randomized controlled trial with blinded assessment at follow-up. Patients with ischemic stroke, first or recurrent, admitted to the stroke unit within 24 h of stroke onset who met physiological criteria were randomly assigned (1:1:1) to 3 groups: Routine Mobilization (RM) received a lower dose of out-of-bed mobilization (<1.5h/d) 24-48 h post-stroke, Very Early and Intensive Mobilization (VEIM) received a higher dose of out-of-bed mobilization (≥3h/d) within 24 h, and Early and Intensive Mobilization (EIM) received a higher dose of out-of-bed mobilization (≥3h/d) 24-48 h post-stroke. Out-of-bed mobilization involves sitting, standing, and walking with or without assistance. The intervention period lasted 10-14 days. All the patients received standard medical therapy according to their different conditions. Patient function was evaluated with the modified Rankin Scale (mRS) score at discharge, 3 months after, and 6 months after. The primary target was a favorable outcome at follow-up, defined as an mRS score of 0-2. We used the Friedman test and the chi-squared test on a fourfold table for significance. Results: A total of 150 patients were recruited, and 120 (80%) finished the training and follow-up assessment with 30 patients dropping out (10 in RM, 12 in VEIM and 8 in EIM). Patients receiving VEIM had lower odds of a favorable outcome at both 3 and 6 months, although the difference did not reach the p = 0.05 level of significance. In the VEIM group, only 42.1% of patients had a favorable outcome 6 months after discharge, as opposed to 55.0% of RM patients and 61.9% of EIM patients. Conclusions: The higher dose mobilization protocol started within 24 h post-stroke was not associated with an increase of favorable outcomes at both 3 and 6 months post-discharge, but rather with a trend toward poorer outcomes. However, the higher dose mobilization protocol started within 48 h post-stroke may lead to a better outcome.

Left Internal Thoracic Artery Graft Assessment by Firefly Fluorescence Imaging for Robot-Assisted Minimally Invasive Direct Coronary Artery Bypass

2019 ◽  
Vol 14 (2) ◽  
pp. 144-150
Author(s):  
Yoshitsugu Nakamura ◽  
Miho Kuroda ◽  
Yujiro Ito ◽  
Takahiko Masuda ◽  
Shuhei Nishijima ◽  
...  
Keyword(s):  
Blood Flow ◽  
Coronary Artery ◽  
Minimally Invasive ◽  
Fluorescence Imaging ◽  
Coronary Artery Bypass ◽  
Internal Thoracic Artery ◽  
Artery Bypass ◽  
Robot Assisted ◽  
Left Internal Thoracic Artery ◽  
Post Harvest

Objective The da Vinci Xi surgical system (Intuitive Surgical, Sunnyvale, CA, USA) cannot give tactile feedback to surgeons. This shortcoming may increase the risk of left internal thoracic artery (LITA) injury during its harvest. We utilized Firefly Fluorescence Imaging (Firefly) to assess LITA quality in robot-assisted minimally invasive direct coronary artery bypass (R-MIDCAB). Methods We retrospectively reviewed clinical records and intraoperative videos of 30 consecutive patients who underwent R-MIDCAB with LITA–left anterior descending (LAD) coronary bypass. All patients had post-harvest assessment of LITA blood flow by Firefly with 1 mL (2.5 mg/mL) of indocyanine green injection through a central line. Results Twenty-seven of the patients were male, mean age was 67.7 ± 10.7 years. In post-harvest assessment performed before transection of the distal LITA, blood flow in LITA was well visualized in 28 patients. In the remaining 2 patients, 1 had dissection and the other had severe spasm of the LITA. Firefly was also useful for locating LITA and LAD and for assessing blood flow of the graft after anastomosis. Time required for each Firefly assessment was approximately 20 seconds. There were no side effects or complications due to Firefly intraoperatively and postoperatively. Twenty-six patients had postoperative coronary computed tomography; LITA patency rate was 100% (26/26). Conclusion Firefly is fast, simple, and effective for locating and assessing flow in LITA and LAD before and after anastomosis in R-MIDCAB.

Outcomes of Bilateral Internal Thoracic Arteries in Minimally Invasive Coronary Artery Bypass Grafting With Analogy to the SYNTAX Trial

2019 ◽  
Vol 14 (3) ◽  
pp. 227-235
Author(s):  
Pradeep Nambiar ◽  
Sanjay Kumar ◽  
Chander Mohan Mittal ◽  
Ila C. Sarkar
Keyword(s):  
Quality Of Life ◽  
Coronary Artery ◽  
Relative Risk ◽  
Propensity Score ◽  
Minimally Invasive ◽  
Internal Thoracic Artery ◽  
Artery Bypass ◽  
Secondary Outcome

Objectives Minimally invasive CABG is making positive strides in the evolution of coronary artery bypass surgery. We carried out a retrospective study of the efficacy and outcomes of the usage of bilateral internal thoracic arteries in MICS CABG patients over a 6 year period using primary (MACCE) and secondary outcome measures and also carried out a subgroup analysis of patients with diabetes and methodology of revascularization, and with analogy to the SYNTAX trial of the relative risk. Methods Nine hundred and forty patients underwent multivessel MICS CABG via a left mini-thoracotomy from August 2011 to September 2017 and complete revascularization was done using the left internal thoracic artery–right internal thoracic artery Y (LITA–RITA Y) composite conduit. Efficacy and outcomes were evaluated by primary (MACCE) and secondary outcome measures including total length of stay, return to full physical activity, and quality of life. Propensity score matched analyses were carried out in diabetics, in the methodology of revascularization (MICS OPCABG vs. MICS ONCABG), and by comparison to the SYNTAX trial for relative risk. Mean follow-up was 2.9 years (maximum was 5.6 years). Results Out of the 940 patients, 843 (89.6%) were diabetic and 97 (10.4%) were nondiabetic. Average grafts were 3.2. There were 9 mortalities (0.9%). The average ICU and hospital stay was 40 ± 12 hours and 3.1 days. Ten patients (1.06%) required reintervention by angioplasty. A total of 99.3% patients were free from major adverse cardiac and cerebrovascular events (MACCE) at follow-up. Mean follow-up was 33 months and 846 (90%) of the patients were followed up. Based on propensity score–matched groups, patients who had their surgery done by MICS ONCABG (beating heart technique) had greater mean number of grafts and hospital length of stay and had significantly longer ICU stay, extubation in OR and blood loss in comparison to patients who had their CABG done by the MICS OPCABG technique. The new technique has shown favorable risk reduction in comparison to both the arms of the SYNTAX trial. Conclusions The safety, efficacy and outcomes of minimally invasive CABG evaluated by primary (MACCE) and secondary outcomes and quality-of-life measures have been good in this study, especially in diabetics, and have shown results better than conventional CABG. The learning curve can be safely negotiated by using peripheral cardiopulmonary bypass assistance and comparison with the SYNTAX trial has shown a relative reduction in all-cause risk.

scholarly journals Bilateral internal thoracic artery grafting: propensity analysis of the left internal thoracic artery versus the right internal thoracic artery as a bypass graft to the left anterior descending artery

2019 ◽  
Author(s):  
Shinji Ogawa ◽  
Tomohiro Tsunekawa ◽  
Soh Hosoba ◽  
Yoshihiro Goto ◽  
Takayoshi Kato ◽  
...  
Keyword(s):  
Internal Thoracic Artery ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Graft Patency ◽  
Chronic Obstructive ◽  
Left Internal Thoracic Artery ◽  
Left Anterior Descending Artery ◽  
Statistical Adjustment ◽  
Right Internal Thoracic Artery

Abstract OBJECTIVES To compare different configurations of the bilateral internal thoracic arteries for the left coronary system and examine early and late outcomes, including mid-term graft patency. METHODS We reviewed 877 patients who underwent primary isolated coronary artery bypass grafting using in situ bilateral internal thoracic arteries [in situ right internal thoracic artery (RITA)-to-left anterior descending artery (LAD) grafting, n = 683; in situ left internal thoracic artery (LITA)-to-LAD grafting, n = 194]. We compared mid-term patency between the grafts. Propensity score matching was performed to investigate early and long-term outcomes. RESULTS The 2-year patency rate for RITA-to-LAD and LITA-to-LAD grafts were similar. Multivariate analysis revealed that RITA-to-non-LAD anastomosis (P = 0.029), postoperative length of stay (P = 0.003) and chronic obstructive pulmonary disease (P = 0.005) were associated with graft failure. After statistical adjustment, 176 propensity-matched pairs were available for comparison. RITA-to-LAD grafting enabled a more distal anastomosis. Kaplan–Meier analysis revealed that the incidences of death, repeat revascularization and myocardial infarction were significantly higher in the LITA-to-LAD group among both the unmatched and matched samples (P = 0.045 and 0.029, respectively). CONCLUSIONS The mid-term patency and outcomes of RITA-to-LAD grafting are good and reduces future cardiac event, in contrast to LITA-to-LAD grafting.

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