Antithrombotic therapy for durable left ventricular assist devices: protocol for a living systematic review with indirect comparison/network meta-analysis.

BACKGROUND: Left ventricular assist devices (LVADs) have emerged as a successful treatment option for patients with end-stage heart failure. Compared with the best medical therapy, LVADs improve survival and enhance functional capacity and quality of life. However, two major complications compromise this patient population's outcomes: thrombosis and bleeding. Despite technological innovations and better hemocompatibility, these devices alter the rheology, triggering the coagulation cascade and, therefore, require antithrombotic therapy. Anticoagulation and antiplatelet therapies represent the current standard of care. Still, inconsistency in the literature exists, especially whether antiplatelet therapy is required, whether direct oral anticoagulants can replace vitamin K antagonists and even whether phosphodiesterase type 5 inhibitors with their antithrombotic effects could be added to the regimen of anticoagulation. METHODS AND ANALYSIS: We will perform a living systematic review with network meta-analysis and indirect comparison between current antithrombotic therapies, which have and have not been directly compared within clinical trials and observational studies. We will systematically search the following electronic sources: Cochrane Central Register of Controlled Trials (CENTRAL), Medical Literature Analysis and Retrieval System Online (MEDLINE) and Excerpta Medica Database (EMBASE). We will exclusively examine studies published in English from 2016 to the present. Studies conducted before 2016 will be omitted since our primary focus is evaluating continuous flow devices. Two independent reviewers will assess the articles by title, abstract and full text; any disagreement will be resolved through discussion, and a third reviewer will be involved if necessary. The Cochrane Risk of Bias tool will be used to assess the risk of bias. We will then conduct a pairwise meta-analysis; if the assumption of transitivity is satisfied, we will proceed with network meta-analysis using Bayesian methodology. ETHICS AND DISSEMINATION: Formal ethical approval is not required as no primary data are collected. This systematic review and network meta-analysis will delineate the risks of stroke, thromboembolic events, pump thrombosis, gastrointestinal bleeding and mortality in patients equipped with LVADs who are subjected to various antithrombotic regimens. The findings will be disseminated via a peer-reviewed publication and presented at conference meetings. This will enhance clinical practice and guide future research on anticoagulation strategies within this distinct patient cohort. PROSPERO REGISTRATION NUMBER: CRD42023465288.

Prevention of persistent pain with lidocaine infusions in breast cancer surgery (PLAN): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Persistent pain is a common yet debilitating complication after breast cancer surgery. Given the pervasive effects of this pain disorder on the patient and healthcare system, post-mastectomy pain syndrome (PMPS) is becoming a larger population health problem, especially as the prognosis and survivorship of breast cancer increases. Interventions that prevent persistent pain after breast surgery are needed to improve the quality of life of breast cancer survivors. An intraoperative intravenous lidocaine infusion has emerged as a potential intervention to decrease the incidence of PMPS. We aim to determine the definitive effects of this intervention in patients undergoing breast cancer surgery. METHODS: PLAN will be a multicenter, parallel-group, blinded, 1:1 randomized, placebo-controlled trial of 1,602 patients undergoing breast cancer surgery. Adult patients scheduled for a lumpectomy or mastectomy will be randomized to receive an intravenous 2% lidocaine bolus of 1.5 mg/kg with induction of anesthesia, followed by a 2.0 mg/kg/h infusion until the end of surgery, or placebo solution (normal saline) at the same volume. The primary outcome will be the incidence of persistent pain at 3 months. Secondary outcomes include the incidence of pain and opioid consumption at 1 h, 1-3 days, and 12 months after surgery, as well as emotional, physical, and functional parameters, and cost-effectiveness. DISCUSSION: This trial aims to provide definitive evidence on an intervention that could potentially prevent persistent pain after breast cancer surgery. If this trial is successful, lidocaine infusion would be integrated as standard of care in breast cancer management. This inexpensive, widely available, and easily administered intervention has the potential to reduce pain and suffering in an already afflicted patient population, decrease the substantial costs of chronic pain management, potentially decrease opioid use, and improve the quality of life in patients. TRIAL REGISTRATION: This trial has been registered on clinicaltrials.gov (NCT04874038, Dr. James Khan. Date of registration: May 5, 2021).

Irreversible Acquired Noncompaction Cardiomyopathy in a Parturient with Corrected Atrial Septal Defect: A Case Report and Clinical Implications.

Left ventricular noncompaction (LVNC) is described as a cardiomyopathy with an increase in left ventricle trabeculations and recesses. We report a rare case of persistent pregnancy-acquired LVNC cardiomyopathy and review the anesthetic peripartum management strategies. A 33-year-old parturient was followed closely by the high-risk obstetric service for her second pregnancy. She had an unresolved LVNC cardiomyopathy that was diagnosed during her first pregnancy for which she had a caesarean section. Her symptoms included occasional palpitations and dyspnea. She was started on metoprolol and enoxaparin. A successful caesarean section was performed at 37 weeks gestation under regional anesthesia. Echocardiograms prior to and during the second pregnancy demonstrated persistence of the LV hypertrabeculations, LV systolic dysfunction, and a left ventricular ejection fraction (LVEF) of 35%. Pregnancy-induced LV hypertrabeculations occur in a significant proportion of women, but most cases spontaneously resolve completely. Favorable maternal and fetal outcomes require multidisciplinary care and careful selection of the anesthetic technique and drugs that maintain stable hemodynamics.

Pulmonary Artery Catheter Knotted in the Tricuspid Valve Apparatus Requiring Surgery With Cardiopulmonary Bypass: A Case Report.

Placement of a pulmonary artery catheter (PAC) is associated with complications such as entrapment or knotting. PAC entrapment in the heart, vena cava, or pulmonary artery is serious, potentially life-threatening, particularly if they are unrecognized. We present a patient with a PAC knot after aortic valve replacement. Interventional radiology (IR) determined that the catheter may have lodged in the tricuspid valve. Surgical exploration requiring cardiopulmonary bypass revealed that the PAC had passed through the tricuspid valve orifice and knotted itself around the anterior leaflet chordal structure. The catheter was unknotted, with the patient subsequently recovering without long-term sequelae.

An up-down determination of the required seated duration after intrathecal injection of bupivacaine and fentanyl for the prevention of hypotension during Cesarean delivery.

PURPOSE: A prolonged seated time after intrathecal injection of hyperbaric bupivacaine and morphine is related to the incidence of hypotension during Cesarean delivery, but results in a high incidence of pain during peritoneal closure. We conducted this study to determine the effect of the addition of intrathecal fentanyl on the relationship between seated time and hypotension and intraoperative analgesia requirements. METHODS: Women undergoing Cesarean delivery were randomized to receive an intrathecal injection of either 11.25 or 15 mg of hyperbaric bupivacaine with morphine 150 µg and fentanyl 15 µg using a combined spinal-epidural technique. The seated duration following intrathecal injection was assigned using up-down methodology. If the preceding patient was hypo- or normotensive, the next patient sat for 15 sec more or less, respectively. A systolic blood pressure < 80% of the preoperative value was defined as hypotension; a standardized anesthetic was administered, and the presence of pain during the procedure was recorded. Isotonic regression of pooled adjacent violators was used to determine the time at which 50% of each group would avoid hypotension (i.e., the median effective seated time). RESULTS: There were 15 patients in each group. The median seated time was 129 sec (95% confidence interval [CI], 116 to 150) for the 11.25-mg group and 459 sec (95% CI, 444 to 471) for the 15-mg group. Only one (3%) of the 30 patients in the study had pain on peritoneal closure, and this was successfully treated with intravenous fentanyl. CONCLUSION: We have determined the seated time required following intrathecal injection of hyperbaric bupivacaine, morphine, and fentanyl to prevent hypotension in 50% of patients undergoing Cesarean delivery. TRIAL REGISTRATION: www.clinicaltrials.gov , NCT01896960. Registered 2 July 2013.