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The mid-point transverse process to pleura block (MTPB) is a new variant of thoracic paravertebral block (TPVB). This study aimed to compare TPVB and MTPB with respect to intraoperative attenuation of the hemodynamic stress response to surgery and postoperative analgesia in pediatric open heart surgery with midline sternotomy. A single-center, randomized, controlled, double-blind, non-inferiority study. Tertiary care children's university hospital. We recruited 83 children aged 2–12 years of both sexes with American Society of Anesthesiologists (ASA) physical status class II who were scheduled for elective open cardiac surgeries with midline sternotomy for the repair of simple noncyanotic congenital heart defects. Eligible participants were randomized into either the TPVB or MTPB groups at a ratio of 1:1. In the TPVB group, patients were bilaterally injected with 0.4 ml/kg of 0.25% bupivacaine in the paravertebral space at T4 and T5. In the MTPB group, patients were bilaterally injected with 0.4 ml/kg of 0.25% bupivacaine mid-transverse process and pleura just posterior to superior costotransverse ligament at the level of T4 and T5. The primary outcome was the hemodynamic responses to sternotomy incision, including heart rate (HR) and invasive mean arterial pressure (MAP), recorded before and after the induction of anesthesia, after skin incision, after sternotomy, 15 min after cardiopulmonary bypass (CPB), and after the closure of the sternum. The secondary outcomes were time needed to perform the bilateral block, intraoperative fentanyl consumption, postoperative fentanyl consumption, modified objective pain score (MOPS) measured at 1, 2, 6, 12, 18, and 24 h after extubation, extubation time, intensive care unit (ICU) discharge time, and the incidence of non-surgical complications (postoperative pruritus, postoperative vomiting, pneumothorax, hematoma or local anesthetic toxicity). There were no significant differences in HR and MAP in the TPVB group compared with the MTPB group at the following time points: baseline, after induction, after skin incision, after sternotomy, 15 min after CPB, and after sternal closure. Intergroup comparisons of HR and MAP did not reveal significant differences between the groups. The median (IQR) time needed to perform bilateral MTPB (7[6–8] min) was significantly (p < 0.001) shorter than that of TPVB (12[10−13] min). Intraoperative fentanyl consumption and fentanyl consumption in the first postoperative 24 h after extubation were similar in the TPVB and MTPB groups (4[2–4] vs 4[2–4] and 4.66 ± 0.649 vs 4.88 ± 1.082 μg/kg), respectively. Extubation time and ICU discharge time were comparable in the TPVB and MTPB groups (2[1–3] vs 2[1–3] h and 21.2 ± 2.5 vs 20.8 ± 2.6 h), respectively. Measurements of MOPS pain scores at 1, 2, 6, 12, 18, and 24 h after extubation were similar in both groups. The incidence of nonsurgical complications was similar in both groups. MTPB is non-inferior to TPVB in attenuating the intraoperative hemodynamic stress response to noxious surgical stimuli and in reducing perioperative opioid consumption, extubation time, and ICU discharge time. Moreover, MTPB is technically easier than TPVB and requires less time to perform. Clinical trial registration number The clinical trial registration was prospectively performed at the Pan African Clinical Trials Registry (PACTR202204901612169, approval date 01/04/2022, URL https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=22602). •Mid-point transverse process to pleura block (MTPB) is a new variant of thoracic paravertebral block (TPVB).•The effectiveness of TPVB in blunting hemodynamic stress response and postoperative analgesia is well-established.•MTPB is non-inferior to TPVB in attenuation surgical hemodynamic stress response and providing perioperative analgesia.

Purpose Postoperative pain after cardiac surgery, exacerbated by cough and sternal mobilization, limits clearance of bronchopulmonary secretions and may predispose to postoperative pneumonia. In this study, we tested the ability of local anesthetic continuous wound infusion to prevent pneumonia after cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) owing to better analgesia and bronchopulmonary drainage. Methods In this randomized, double-blind, placebo-controlled trial conducted in five academic centers, patients undergoing cardiac surgery with sternotomy and CPB were enrolled from February 2012 until November 2014, and were followed over 30 days. Patients were assigned to a 48-h infusion (10 ml h −1 ) of l -bupivacaine (12.5 mg h −1 ) or placebo (saline) via a pre-sternal multiperforated catheter. Anesthesia and analgesia protocols were standardized. The primary end point was the incidence of pneumonia during the study period, i.e., until hospital discharge or 30 days. We hypothesized a 30% reduction in the incidence of pneumonia. Results Among 1493 randomized patients, 1439 completed the trial. Pneumonia occurred in 36/746 patients (4.9%) in the l -bupivacaine group and in 42/739 patients (5.7%) in the placebo group (absolute risk difference taking into account center and baseline risk of postoperative pneumonia, − 1.3% [95% CI − 3.4; 0.8] P  = 0.22). In the predefined subgroup of patients at high risk, l -bupivacaine decreased the incidence of pneumonia (absolute risk difference, − 5.6% [95% CI − 10.0; − 1.1], P  = 0.01). Conclusions After cardiac surgery with sternotomy, continuous wound infusion of l -bupivacaine failed to decrease the incidence of pneumonia. These findings do not support the use of local anesthetic continuous wound infusion in this indication. Further study should investigate its effect in high-risk patients. Trial registration EudraCT Number: 2011-003292-10; Clinicaltrials.gov Identifier: NCT01648777.

BackgroundLinear hypertrophic scar is a common surgical problem that can be difficult to manage, especially for the median sternotomy scar. Botulinum toxin type A (BTA) is widely used in cosmetic surgery and has been shown to improve scar quality recently. The aim of this study was to evaluate the efficacy of BTA injected in the early postoperative of median sternotomy on preventing scar formation.MethodsIn this prospective randomized controlled trial, 19 consecutive patients who underwent median sternotomy were enrolled. The median sternotomy wound in each patient was divided into the upper half and the lower half. Both halves of the wound were randomized to receive the treatment with either BTA or normal saline. At 6-month follow-up, scars were assessed using the Vancouver Scar Scale, scar widths were measured, and patients were asked to evaluate their overall satisfaction.ResultsSeventeen patients with median sternotomy wounds completed the entire study. At 6-month follow-up, the mean Vancouver Scar Scale score for the BTA-treated group was 3.44 ± 1.68 and for the normal saline control group was 6.29 ± 2.39, and there was a statistically significant difference between the two groups (P < 0.05). There were also significant improvements in scar width and patient satisfaction for the BTA-treated halves of the wounds (P < 0.05).ConclusionsThe study demonstrates that early postoperative BTA injection can decrease scar formation and reduce scar width in median sternotomy wounds, and the overall appearance is more satisfactory.Level of Evidence IThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Background Observational studies have shown reduced perioperative bleeding in patients undergoing minimally invasive, compared with full sternotomy, aortic valve replacement. Data from randomized trials are conflicting. Methods This was a Swedish single center study where adult patients with aortic stenosis, 100 patients were randomly assigned in a 1:1 ratio to undergo either minimally invasive (ministernotomy) or full sternotomy aortic valve replacement. The primary outcome was severe or massive bleeding defined by the Universal Definition of Perioperative Bleeding in adult cardiac surgery (UDPB). Secondary outcomes included blood product transfusions, chest tube output, re-exploration for bleeding, and several other clinically relevant events. Results Out of 100 patients, three patients randomized to ministernotomy were intraoperatively converted to full sternotomy (none was bleeding-related). Three patients (6%) in the full sternotomy group and 3 patients (6%) in the ministernotomy group suffered severe or massive postoperative bleeding according to the UDPB definition ( p  = 1.00). Mean chest tube output during the first 12 postoperative hours was 350 (standard deviation (SD) 220) ml in the full sternotomy group and 270 (SD 190) ml in the ministernotomy group ( p  = 0.08). 28% of patients in the full sternotomy group and 36% of patients in the ministernotomy group received at least one packed red blood cells transfusion ( p  = 0.39). Two patients in each group (4%) underwent re-exploration for bleeding. Conclusions Minimally invasive aortic valve replacement did not result in less bleeding-related outcomes compared to full sternotomy. Clinical Trial Registration http://www.clinicaltrials.gov . Unique identifier: NCT02272621.

Background Aortic valve replacement is one of the most common cardiac surgical procedures performed worldwide. Conventional aortic valve replacement surgery is performed via a median sternotomy; the sternum is divided completely from the sternal notch to the xiphisternum. Minimally invasive aortic valve replacement, using a new technique called manubrium-limited ministernotomy, divides only the manubrium from the sternal notch to 1 cm below the manubrio-sternal junction. More than one third of patients undergoing conventional sternotomy develop clinically significant bleeding requiring post-operative red blood cell transfusion. Case series data suggest a potentially clinically significant difference in red blood cell transfusion requirements between the two techniques. Given the implications for National Health Service resources and patient outcomes, a definitive trial is needed. Methods/design This is a single-centre, single-blind, randomised controlled trial comparing aortic valve replacement surgery using manubrium-limited ministernotomy (intervention) and conventional median sternotomy (usual care). Two hundred and seventy patients will be randomised in a 1:1 ratio between the intervention and control arms, stratified by baseline logistic EuroSCORE and haemoglobin value. Patients will be followed for 12 weeks from discharge following their index operation. The primary outcome is the proportion of patients who receive a red blood cell transfusion post-operatively within 7 days of surgery. Secondary outcomes include red blood cell and blood product transfusions, blood loss, re-operation rates, sternal wound pain, quality of life, markers of inflammatory response, hospital discharge, health care utilisation, cost and cost effectiveness and adverse events. Discussion This is the first trial to examine aortic valve replacement via manubrium-limited ministernotomy versus conventional sternotomy when comparing red blood cell transfusion rates following surgery. Surgical trials present significant challenges; strengths of this trial include a rigorous research design, standardised surgery performed by experienced consultant cardiothoracic surgeons, an agreed anaesthetic regimen, patient blinding and consultant-led patient recruitment. The MAVRIC trial will demonstrate that complex surgical trials can be delivered to exemplary standards and provide the community with the knowledge required to inform future care for patients requiring aortic valve replacement surgery. Trial registration International Standard Randomised Controlled Trial Number (ISRCTN) ISRCTN29567910 . Registered on 3 February 2014.

The substance completely dissolves in 48 hours, and after three weeks, bone regrowth has been observed, although it does not seem to promote bone growth.2 The hydroxyapatite and polylactic acid (HA/PLA), BoneSeal (Hemostasis, LLC, St. Paul, MN), is an absorbable synthetic bone hemostatic agent, with beeswax consistency that also contains PLA, polyethylene glycol polymer, and hydroxyapatite, which supports bone regrowth. Approval was obtained from the Institutional Review Board of Loma Linda University Medical Center. Because it is not water soluble and biodegrades in few weeks, it demonstrated a better hemostatic effect than WSW, which dissolves after a few minutes and may lead to rebleeding.

Background During the last decade, the use of ministernotomy in cardiac surgery has increased. Quality of life and patient satisfaction after ministernotomy have never been compared to conventional full sternotomy in randomised trials. The aim of the study is to determine if this minimally invasive approach improves quality of life, satisfaction and clinical morbimortality outcomes. Methods/design The QUALITY-AVR trial is a single-blind, single-centre, independent, and pragmatic randomised clinical trial comparing ministernotomy (“J” shaped upper hemisternotomy toward right 4th intercostal space) to full sternotomy in patients with isolated severe aortic stenosis scheduled for elective aortic valve replacement. One hundred patients will be randomised in a 1:1 computational fashion. Sample size was determined for the primary end point with alpha error of 0.05 and with power of 90% in detecting differences between intervention groups of ≥ 0.10 points in change from baseline quality of life Questionnaire EuroQOL-index (EQ-5D-5 L®), measured at 1, 6 or 12 months. Secondary endpoints are: the differences in change from other baseline EQ-5D-5 L® utilities (visual analogue scale, Health Index and Severity Index), cardiac surgery specific satisfaction questionnaire (SATISCORE®), a combined safety endpoint of four major adverse complications at 1 month (all-cause mortality, acute myocardial infarction, neurologic events and acute renal failure), bleeding through drains within the first 24 h, intubation time, postoperative hospital and intensive care unit length of stay, transfusion needs during the first 72 h and 1-year survival rates. Clinical follow up is scheduled at baseline, 1, 6, and 12 months after randomization. All clinical outcomes are recorded following the Valve Academic Research Consortium 2 criteria. Discussion The QUALITY-AVR trial aims to test the hypothesis that ministernotomy improves quality of life, satisfaction and clinical outcomes in patients referred for isolated aortic valve replacement. Statistically significant differences favouring ministernotomy could modify the surgical “gold standard” for aortic stenosis surgery, and subsequently the need to change the control group in transcatheter aortic valve implantation trials. Recruitment started on 18 March 2016. In November 2017, 75 patients were enrolled. Trial registration ClinicalTrials.gov , NCT02726087 . Registered on 13 March 2016.

Objectives: To clarify whether the results of repair of a complex mitral lesion (Barlow valve) at the intermediate-term follow-up are independent of the mode of surgical access [minithoracotomy vs. median sternotomy (MS)]. Methods: In a prospective randomized study of mitral repair for Barlow disease using either a minimally invasive (MI) approach or MS, we achieved an average follow-up of 3 years (echocardiography, physical examination and quality of life). Mitral repair was achieved with polytetrafluoroethylene chordal implantation for both leaflets. Results: Both groups included 80 patients. Mechanical ventilation time and intensive care unit and hospital stay were shorter in the MI group (p = 0.01, p = 0.013 and p = 0.02, respectively). During the follow-up, 5 patients in each group (6.25%) displayed mild mitral regurgitation, while 2 patients in each group (2.5%) developed recurrent regurgitation graded as at least moderate/severe. The rate of mitral reoperation was 2.5% in the MI group and 1.25% in the MS group (p = 0.9). The overall follow-up mortality was 3.75% in both the MI and the MS groups. Conclusions: The 3-year results of repair of Barlow valves were satisfactory irrespective of the approach used to repair the valve. The advantages of MI surgery can be achieved in patients with mitral Barlow disease without concerns over the durability of repair.

The aim of this study was to analyze the healing effects of low-level laser therapy (LLLT) on the longitudinal sternotomy incisions of patients who underwent coronary artery bypass graft (CABG). The volunteers were randomized into three groups of equal size ( n  = 30): control, placebo, and laser ( λ  = 660 nm and spatial average energy fluency [SAEF] = 1.06 J/cm 2 ). The patients in the laser group underwent irradiation on postoperative days 2, 4, 6, and 8, and their sternotomy incisions were photographed immediately after the surgery and 8 days later for analysis. Three researchers who were blinded to the patient treatment groups analyzed the incision photographs to assess hyperemia and wound closure on the day of hospital discharge (eighth postoperative day). The sternotomy incisions in the LLLT group demonstrated less hyperemia, incisional bleeding, and dehiscence ( p  ≤ 0.005).

Objective The preferred surgical approach for systemic-pulmonary shunts has changed from thoracotomy to sternotomy in our institution, to concomitantly manage the ductus arteriosus during surgery. The purpose of this study was to compare the outcomes of systemic-pulmonary shunts for neonates with functionally univentricular hearts based on surgical approach. Methods Fifty-two neonates with functionally univentricular hearts underwent systemic-pulmonary shunt via sternotomy ( n  = 28) or thoracotomy ( n  = 24). Patient characteristics, achievement rates of right heart bypass, and survival rates were compared for the different approaches. Results Prenatal diagnosis was made more common in the sternotomy group ( p  = 0.006). The shunt was placed more centrally in the sternotomy group. The ductus arteriosus was ligated or banded in most patients in the sternotomy group (26/28) and in a few patients in the thoracotomy group (6/24). Frequency of ductal management in the early postoperative phase was not different between the groups (21 vs 25 %), but three new incisions had to be made in the thoracotomy group. No differences were seen in the achievement rates of bidirectional cavopulmonary shunts (86 vs 87 % at 10 months of age) and total cavopulmonary connection (81 vs 81 % at 2 years of age), or in the survival rates (92 vs 96 % at 8 years). Conclusions There were no differences in short- and long-term outcomes between the groups. The sternotomy approach might be preferable in the current era of prenatal diagnosis, to allow simultaneous duct management during systemic-pulmonary shunt surgery, particularly in patients with large ducts associated with functionally univentricular hearts.