Prospective randomized double-blind study to evaluate the superiority of Vasopressin versus Norepinephrine in the management of the patient at renal risk undergoing cardiac surgery with cardiopulmonary bypass (NOVACC trial).

BACKGROUND: Cardiac surgery-associated acute kidney injury (CS-AKI) affects up to 30% of patients, increasing morbidity and healthcare costs. This condition results from complex factors like ischemia-reperfusion injury and renal hemodynamic changes, often exacerbated by surgical procedures. Norepinephrine, commonly used in cardiac surgeries, may heighten the risk of CS-AKI. In contrast, vasopressin, a noncatecholaminergic agent, shows potential in preserving renal function by favorably affecting renal hemodynamic. Preliminary findings, suggest vasopressin could reduce the incidence of CS-AKI compared to norepinephrine. Additionally, vasopressin is linked to a lower incidence of postoperative atrial fibrillation, another factor contributing to longer hospital stays and higher costs. This study hypothesizes that vasopressin could effectively reduce CS-AKI occurrence and severity by optimizing renal perfusion during cardiac surgeries. STUDY DESIGN: The NOVACC trial (NCT05568160) is a multicenter, randomized, double blinded superiority-controlled trial testing the superiority of vasopressin over norepinephrine in patients scheduled for cardiac surgery with cardiopulmonary bypass (CPB). The primary composite end point is the occurrence of acute kidney injury and death. The secondary end points are neurological, cardiologic, digestive, and vasopressor related complications at day 7, day 30, day 90, hospital and intensive care unit lengths of stay, medico-economic costs at day 90. CONCLUSION: The NOVACC trial will assess the effectiveness of vasopressin in cardiac surgery with CPB in reducing acute kidney injury, mortality, and medical costs. CLINICAL TRIAL REGISTRATION: NCT05568160.

Perioperative individualized hemodynamic optimization according to baseline mean arterial pressure in cardiac surgery patients: Rationale and design of the OPTIPAM randomized trial.

BACKGROUND: Postoperative morbidity and mortality after cardiac surgery with cardiopulmonary bypass (CPB) remain high despite recent advances in both anesthesia and perioperative management. Among modifiable risk factors for postoperative complications, optimal arterial pressure during and after surgery has been under debate for years. Recent data suggest that optimizing arterial pressure to the baseline of the patient may improve outcomes. We hypothesize that optimizing the mean arterial pressure (MAP) to the baseline MAP of the patient during cardiac surgery with CPB and during the first 24 hours postoperatively may improve outcomes. STUDY DESIGN: The OPTIPAM trial (NCT05403697) will be a multicenter, randomized, open-label controlled trial testing the superiority of optimized MAP management as compared with a MAP of 65 mm Hg or more during both the intraoperative and postoperative periods in 1,100 patients scheduled for cardiac surgery with CPB. The primary composite end point is the occurrence of acute kidney injury, neurological complications including stroke or postoperative delirium, and death. The secondary end points are hospital and intensive care unit lengths of stay, Day 7 and Day 90 mortality, postoperative cognitive dysfunction on Day 7 and Day 90, and quality of life at Day 7 and Day 90. Two interim analyses will assess the safety of the intervention. CONCLUSION: The OPTIPAM trial will assess the effectiveness of an individualized target of mean arterial pressure in cardiac surgery with CPB in reducing postoperative morbidity. CLINICAL TRIAL REGISTRATION: NCT05403697.

Fast-track anesthesia with remifentanil and spinal analgesia for cardiac surgery: the effect on pain control and quality of recovery.

OBJECTIVES: To assess pain intensity and quality of postoperative recovery in patients given fast-track anesthesia and spinal analgesia versus patients treated with standard anesthesia. DESIGN: A prospective, randomized, controlled study. SETTING: A private institution. PARTICIPANTS: Eighty-three patients who underwent cardiac surgery with cardiopulmonary bypass were analyzed. INTERVENTIONS: General anesthesia consisted of remifentanil and spinal analgesia (low-dose morphine and clonidine) for the fast-track group (FTG) and sufentanil without spinal analgesia for the control group (CG). During the postoperative period, paracetamol and patient-controlled intravenous analgesia (PCA) with morphine were given. MEASUREMENTS AND MAIN RESULTS: Postoperative pain intensity was evaluated during 48 hours with visual analog scale scores and intravenous morphine consumption. Pain impact on quality of life was assessed with the brief pain inventory (BPI) score (days 1-8), and recovery was evaluated with the quality of recovery score (QoR-40, day 4). Compared with the CG, FTG pain intensity was significantly lower 0 to 4 (p < 0.01) and 6 to 12 hours (p < 0.05) after surgery, as was their cumulative intravenous PCA morphine consumption (p = 0.01). BPI scores supported that FTG patients had significantly (p < 0.01) less "pain at its worst" on days 1 and 2, their BPI-assessed pain interfered significantly less with daily life on day 1 (p < 0.001), and their global QoR-40 score (day 4) was significantly higher (p < 0.05). CONCLUSIONS: Fast-track anesthesia combined with morphine-clonidine spinal analgesia controlled postoperative pain better and obtained a better QoR than conventional analgesia.

Transcatheter valve-in-valve implantation in a degenerated very small Mitroflow prosthesis.

OBJECTIVES: To assess the feasibility and results of 'valve-in-valve' implantation using the 23-mm CoreValve for the treatment of degenerated 19-mm and 21-mm Mitroflow bioprostheses. METHODS: We retrospectively analysed all consecutive patients who underwent transcatheter aortic valve implantation for 19-mm and 21-mm Mitroflow bioprostheses. The height of implantation with respect to the ring of the Mitroflow prosthesis was targeted at -6 mm for the first 3 cases. In the following cases, the target was higher to promote free supra-annular movement of the leaflets. RESULTS: The procedure was successful in 17 of 18 patients (94%). For implantations above the limit of -6 mm, the mean gradient was 10.4 ± 2.6 mmHg compared with 28.1 ± 11.6 mmHg for implantations below the limit of -6 mm (P < 0.01). For patients with severe stenosis as main mechanism of failure of the bioprosthesis, the mean post-procedural gradient was 31.2 ± 11.8 mmHg compared with 12.7 ± 6 mmHg in the absence of severe stenosis (P < 0.01). Patient-prosthesis mismatch (indexed effective orifice area ≤ 0.85 cm2/m2) and severe mismatch (indexed effective orifice area ≤ 0.65 cm2/m2) were present in 83% (15 of 18) and 27% (5 of 18) of patients, respectively. We did not notice any complications following the procedures. Six months after the procedure, functional status was improved in all patients. CONCLUSIONS: Our short series demonstrates the ability to perform transcatheter 'valve-in-valve' implantation in 19-mm and 21-mm Mitroflow prostheses with satisfactory results, but high post-procedural gradients and patient-prosthesis mismatch remain a relatively frequent problem mostly when severe stenosis is the main mechanism of failure. Implantation in a high position is critical to decrease the rate of high postimplantation gradients.