RESUMEN
Objectives: Postoperative atrial fibrillation (POAF) is a frequent complication following cardiac surgery. This study examined the safety and efficacy of the new DefiPace TM system consisting of two bi-atrial temporary pacing and cardioversion electrodes, a ventricular electrode and the DefiPace TM device (combined external pacemaker and cardioverter) for low-energy atrial cardioversion. Methods: The temporary electrodes were placed on the left and right atrium during open heart surgery. Pacing thresholds and sensing were measured up to the 6th postoperative day. The satisfactory handling of the electrodes was measured with a visual analog scale (VAS) 1-10, with 10 being the best and 1 being the lowest. In case of POAF, R-wave synchronous low-energy shocks (0.5-10 J) were applied for cardioversion. Results: Temporary electrodes were implanted in 29 patients (age 65.6 ± 10.4 years; 21 males, 14 OPCAB, 15 on-pump cardiac operations). Left or right atrial pacing thresholds ranged from 1.9 ± 1.3 V/ms to 5.0 ± 3.3 V/ms and P-wave sensing from 0.9 ± 0.6 mV to 1.5 ± 0.7 mV. VAS for handling of electrodes: implantation 7.1 ± 0.8 and removal 8.4 ± 1.0. POAF was observed in four patients. Two patients had successful atrial cardioversion with 3.5 J and 4.5 J. One patient converted spontaneously, and one patient remained in PAOF. There were no device-related adverse events. Conclusions: The DefiPace TM system can be used safely in patients undergoing cardiac surgery.
RESUMEN
Despite increasing clinical interest in adapting checkpoint inhibitor (CPI) therapies for patients with gynecologic malignancies, no accurate clinical biomarkers to predict therapy response and prognosis are currently available. Therefore, we aimed to assess the predictive and prognostic value of pretherapeutic body mass index (BMI) for recurrent gynecologic cancer patients as previously validated for other solid tumors. We evaluated patients with programmed cell death ligand 1 (PD-L1) positive and, in endometrial cancer, also mismatch repair deficient (MMR) gynecologic malignancies, who received the PD-1 inhibitor pembrolizumab as monotherapy (200 mg fixed-dose q3 w) from 2017 to 2020 (n = 48). Thirty-six patients receiving at least four courses were included in the final analysis. Associations between a BMI increase per 5 kg/m2 and overall response rate (ORR; complete + partial response), disease control rate (DCR; ORR + stable disease), progression-free (PFS), and overall survival (OS) were assessed. An elevated BMI was univariately associated with ORR (OR 10.93 [CI 2.39-49.82], p = 0.002), DCR (OR 2.19 [CI 0.99-4.83], p = 0.048), prolonged PFS (HR 1.54 [CI 1.03-2.34], p = 0.038), and OS (HR 1.87 [CI 1.07-3.29], p = 0.028). All results could be confirmed in the multivariate analyses. Pretherapeutic BMI therefore appears to be a promising readily available biomarker to identify patients with PD-L1-positive and/or MMR-deficient gynecologic malignancies who could particularly benefit from CPI treatment.
