Incidence Of Composite Adverse Events Research Articles

Same-day Discharge Following Vaginal Hysterectomy and Native-tissue Apical Repair for Uterovaginal Prolapse: A Prospective Cohort Study.

The safety and feasibility of same-day discharge (SDD) has been consistently reported across the benign and gynecologic oncology literature. However, outcomes of SDD in the urogynecology population are sparse. The objectives of this study were to describe the success of SDD following vaginal hysterectomy and native-tissue colpopexy, and to compare the incidence of postoperative adverse events in patients discharged same-day versus postoperative day 1 (POD1). Further objectives were to compare pain, quality of recovery (QoR), and satisfaction between the groups. This was a single-center, prospective cohort study of patients with planned SDD. A standardized ERAS protocol was utilized. The QoR-40 questionnaire was administered at baseline, POD2, and the 6-week postoperative visit. Pain scores were captured similarly, and a satisfaction survey was administered at 6 weeks. The primary outcome was composite adverse events defined as any postoperative adverse event and/or health care utilization, excluding telephone calls, and urinary tract infection. A total of 101 patients were enrolled in the study; the primary outcome was available for 99. SDD was achieved for 76 patients (77.0%); 23 patients stayed overnight (23.2%). The overall incidence of composite adverse events was 20.2% (95% CI, 13.5-29.2), and was not different between the groups (26.1% vs 18.4%, p = 0.42). Additionally, there were no differences in the QoR-40 or pain scores on POD2 and at 6 weeks. Patient satisfaction was high and similar between the groups. Successful SDD was achieved in 77.0% of the patients. SDD following vaginal hysterectomy and native-tissue colpopexy appears to be safe, feasible, and associated with good QoR and a high degree of patient satisfaction.

Intraoperative partial pressure of arterial carbon dioxide levels and adverse outcomes in patients undergoing lung transplantation

ObjectivePatients undergoing lung transplantation (LTx) often experience abnormal hypercapnia or hypocapnia. This study aimed to investigate the association between intraoperative PaCO2 and postoperative adverse outcomes in patients undergoing LTx. MethodsWe retrospectively reviewed the medical records of 151 patients undergoing LTx. Patients’ demographics, perioperative clinical factors, and pre- and intraoperative PaCO2 data after reperfusion were collected and analyzed. Based on the PaCO2 levels, patients were classified into three groups: hypocapnia (≤35 mmHg), normocapnia (35.1–55 mmHg), and hypercapnia (>55 mmHg). Univariate and multivariable logistic regressions were used to identify independent risk factors for postoperative composite adverse events and in-hospital mortality. ResultsIntraoperative hypercapnia occurred in 69 (45.7%) patients, and hypocapnia in 17 (11.2%). Patients with intraoperative PaCO2 of 35.1–45 mmHg showed a lower incidence of composite adverse events (53.3%) and mortality (6.2%) (P < 0.001). There was no significant difference in composite adverse events and mortality among preoperative PaCO2 groups (P > 0.05). Compared with intraoperative PaCO2 at 35.1–45 mmHg, the risk of composite adverse events in hypercapnia group increased: the adjusted OR was 3.07 (95% confidence interval [CI]: 1.36–6.94; P = 0.007). The risk of death was significantly higher in hypocapnia group than normocapnia group, the adjusted OR was 7.69 (95% CI: 1.68–35.24; P = 0.009). Over ascending ranges of PaCO2, PaCO2 at 55.1–65 mmHg had the strongest association with composite adverse events, the adjusted OR was 6.40 (95% CI: 1.18–34.65; P = 0.031). ConclusionThese results demonstrate that intraoperative hypercapnia independently predicts postoperative adverse outcomes in patients undergoing LTx. Intraoperative hypocapnia shows predictive value for postoperative in-hospital mortality in LTx.

Patient Safety during Propofol Sedation before and after Implementation of Capnography Monitoring.

Endoscopic procedures are routinely applied to cancer screening programs and surveillance. The preferred technique is usually deep sedation with propofol being a convenient agent allowing for a quicker patient recovery while maintaining a similar safety profile compared to traditional agents. However, adverse events, including respiratory depression and consequent undesirable cardiovascular side effects, may occur. The goal of this work is to evaluate the patient safety impact of adding capnography during endoscopic procedures under deep propofol sedation. Data were retrospectively collected from patients undergoing deep, procedural sedation for gastrointestinal (GI) endoscopy in October 2019 to January 2021 in a single Turkish university hospital. Included in the analysis were all adult patients classified by the American Society of Anesthesiologists (ASA) as I-IV, who were scheduled for GI endoscopy utilizing propofol alone or in combination. Data on 1840 patients were collected, of whom 1610 (730 pre- and 880 post-capnography implemention) met inclusion criteria. The primary outcome was a change in the composite incidence of mild oxygen desaturation (SpO2 75-90% for <60 s), severe oxygen desaturation (SpO2 < 75% anytime or <90% for >60 s), bradycardia (<60 ppm), and tachycardia (>25% from baseline). Without capnography, on average, 7.5 events of the primary endpoint were observed per 100 procedures and 2.9 with additional capnography monitoring (p < 0.001). A significant reduction was observed for mild oxygen desaturation, with a resulting odds ratio of 0.25 (95% CI 0.14 to 0.46). ASA I patients had the highest difference in combined incidence of any oxygen desaturation of 5.85% in the pre-capnography group and 0.64% in the post-capnography group. Although procedural sedation using propofol is not associated with severe adverse events, the incidence of composite adverse events could be reduced with the addition of capnography monitoring.

Clinical Implication of the Right Ventricular/Left Ventricular Diameter Ratio in Patients with Pulmonary Thromboembolism.

The role of the right to left ventricular (RV/LV) diameter ratio in predicating long-term outcomes in patients with pulmonary thromboembolisms (PTEs) treated with direct oral anticoagulants is unclear.We investigated the association between the RV/LV diameter ratio and clinical outcomes in PTE patients under rivaroxaban from the data of a multicenter, prospective, observational study (J'xactly Study) in Japanese patients with acute venous thromboembolisms (VTEs) including deep vein thromboses, PTEs, or both. Of a total of 1,039 patients with an acute VTE (from December 2016 to April 2018), 429 were diagnosed with PTEs, however, the population in this study consists of 216 patients in whom the RV/LV diameter ratio measured on the axial CT or transthoracic echocardiogram was available.The RV/LV diameter ratio increased significantly with the severity of the PTE classification (nonmassive 0.79 [0.67-0.93], submassive 1.10 [0.83-1.31], massive 1.13 [0.94-1.19], arrest or collapse 1.38 [0.66-2.38], P < 0.001). During a median follow-up of 624 (550-690) days, a sum of the composite adverse events including recurrent VTEs, acute coronary syndrome, ischemic strokes, death from any cause, or major bleeding events occurred in 26 patients (12.0%, 7.58 events per 100 patient-years). Multivariate analysis revealed that an RV/LV diameter ratio ≥ 1.0 had no association with the incidence of composite adverse events (HR 1.34, 95% confidence interval 0.59-2.91, P = 0.48).In summary, in Japanese PTE patients under rivaroxaban, the RV/LV diameter ratio measured on the CT or transthoracic echocardiogram was associated with the PTE severity, but not with the clinical outcomes.

Infantile survival and neurodevelopment at three years of age on delivery by the intended delivery mode in extremely preterm infants

ObjectiveTo elucidate the impact of the intended delivery mode on long-term outcomes among extremely preterm infants. Materials and methodsWomen who delivered singletons between 23 0/7 and 25 6/7 weeks of gestation from January 2010 to March 2014 and their infants were included in this study. The cases of fetal growth restriction and those with a chromosomal or major structural abnormality were excluded. The cases of fetal death that was diagnosed before labor onset and cases of non-reassuring fetal status, placental abruptions or umbilical cord prolapse that was diagnosed at labor onset were also excluded. The primary outcome was the incidence of composite adverse events, including death, cerebral palsy, or neurodevelopmental delay, at the age of three years. The composite adverse events, including death, grade III or IV intraventricular hemorrhage, cystic periventricular leukomalacia, necrotizing enterocolitis, focal intestinal perforation, and sepsis of neonatal period, were assessed as short-term outcomes. The association between the intended delivery mode and primary outcome, short-term outcome, and each component was analyzed using a multivariate logistic regression model. ResultsEighty cases were included in the analyses. Primary outcomes could be assessed in 72 cases. Infantile composite adverse events before discharge were observed in 19 cases (24%). The prevalence of primary outcomes was 40% (29 cases). The intended delivery mode was not associated with primary and short-term outcomes and each component complication. ConclusionAn advantage of intended cesarean delivery in terms of prognosis at three years of age in extremely preterm infants was not observed.

Type II hybrid arch repair versus total arch replacement with frozen elephant trunk: a propensity score-matched analysis

The aim of this study was to evaluate the objective outcomes of type II hybrid arch repair (HAR) and total arch replacement with frozen elephant trunk (TAR with FET). Data from 528 patients who underwent aortic arch repair from January 2017 to June 2019 were collected, which consisted of 175 type II HAR and 353 TAR with FET. The propensity score-matched analysis identified a subgroup of 90 pairs. Perioperative data and mid-term follow-up results were assessed. There was no significant difference in the composite adverse events (type II HAR, 20.6%, 36/175 vs TAR with FET, 17.8%, 63/353, P = 0.450). Multivariable logistic analysis of the 528 patients showed that the procedure type (type II HAR or TAR with FET) was not associated with composite adverse events, 30-day mortality or stroke. The 3-year survival rates were 84.8% in the type II HAR group and 90.1% in the TAR with FET group (P = 0.12). The 3-year reintervention-free rates in the type II HAR and TAR with FET groups were 98.7% and 96.5% (P = 0.22), respectively. After matching, no significant difference was found in the incidence of composite adverse events or the 3-year survival and reintervention-free rates. No significant clinical differences were found in the early and mid-term outcomes of type II HAR and TAR with FET. The long-term outcomes remain to be investigated. Careful patient selection for individualized approaches is the key to taking full advantage of the 2 surgical procedures.

Postoperative Nadir Hemoglobin and Adverse Outcomes in Patients Undergoing On-Pump Cardiac Operation

BackgroundPatients undergoing cardiac operation are susceptible to anemia. Low hemoglobin concentration is a risk factor for composite adverse events and death after cardiac operation. Here we investigated the association of postoperative nadir hemoglobin with adverse outcomes in patients undergoing on-pump cardiac operation. MethodsAdult patients in 2 medical centers were retrospectively analyzed. The primary outcome was postoperative composite adverse events. The secondary outcome was all-cause death in the hospital. ResultsOf the 8206 patients analyzed, 1628 (19.8%) experienced composite adverse events after operation and 109 (1.3%) died. Patients receiving on-pump cardiac operation with nadir hemoglobin of 9.0 to 9.9 g/L showed a low incidence of composite adverse events (175 of 1423 [12.3%]) and death (5 of 1423 [0.4%]). Compared with nadir hemoglobin at 9.0 to 9.9 g/dL, the relative risk (RR) of composite adverse events increased stepwise as nadir hemoglobin fell below 9.0 g/dL: adjusted RR was 1.44 (95% confidence interval [CI], 1.14-1.83) for 8.5 to 8.9 g/dL, 1.56 (95% CI, 1.23-1.99) for 8.0 to 8.4 g/dL, 1.66 (95% CI, 1.31-2.11) for 7.5 to 7.9 g/dL, 2.22 (95% CI, 1.75-2.83) for 7.0 to 7.4 g/dL, and 4.00 (95% CI, 3.18-5.04) for less than 7 .0 g/dL. Furthermore, the risk of death was significantly higher when nadir hemoglobin was below 7.0 g/dL than when it was 9.0 to 9.9 g/dL (RR, 5.36; 95% CI, 2.20-16.12). ConclusionsCompared with the risks when nadir hemoglobin is 9.0 to 9.9 g/dL, the risk of composite adverse events increases when postoperative nadir hemoglobin is below 9.0 g/dL, whereas risk of death increases when nadir hemoglobin is below 7.0 g/dL.

Sutureless versus transcatheter aortic valves in elderly patients with aortic stenosis at intermediate risk: A multi-institutional study

ObjectiveThis multi-institutional study compares the long-term outcome of elderly patients with severe aortic stenosis and an intermediate risk profile undergoing sutureless versus transcatheter aortic valve implantation. MethodsFrom 2008 to 2015, 967 elderly patients (>75 years) with intermediate risk (Society of Thoracic Surgeons score 4%-8%) and isolated aortic stenosis were included in the study (sutureless valve = 481; transcatheter aortic valve implantation = 486). After propensity score matching, 2 matched groups of 291 patients were obtained. Transcatheter valves implanted in patients were the CoreValve (Medtronic, Minneapolis, Minn), Edwards SAPIEN-XT (Edwards Lifesciences, Irvine, Calif), and Acurate-TA (Symetis, Lausanne, Switzerland). Primary end points included all-cause death at 30 days and 5 years. Secondary end points included early and 5-year incidence of composite adverse events (major adverse cardiovascular events: all-cause death, stroke, pacemaker implant, myocardial infarction, paravalvular leak ≥II, and reoperation). ResultsAfter matching, there were no substantial differences between groups. The 30-day mortality was significantly lower in the sutureless valve group (sutureless valve = 1.7% vs transcatheter aortic valve implantation = 5.5%; P = .024) and the rate of permanent pacemaker implantation (sutureless valve = 5.5% vs transcatheter aortic valve implantation = 10.7%, P = .032). Stroke/transient ischemic attack cumulative incidence at 5 years was 1.4% in the sutureless valve group and 5.3% in the transcatheter aortic valve implantation group (P = .010). The incidence of perivalvular leak grade II or greater was 1.3% in the sutureless valve group and 9.8% in the transcatheter aortic valve implantation group (P < .001). At 60 months follow-up, the all-cause death rate was lower in the sutureless valve group than in the transcatheter aortic valve implantation group (sutureless valve = 16.1% ± 4.1% vs transcatheter aortic valve implantation = 28.9% ± 5.3%, P = .006), and the major adverse cardiovascular event rate was lower in the sutureless valve group (sutureless valve = 23.5% ± 4.1% vs transcatheter aortic valve implantation = 39.0% ± 5.6%, P = .002). Multivariable Cox regression identified transcatheter aortic valve implantation as an independent predictor for 5-year mortality and major adverse cardiovascular events (hazard ratio, 1.86; confidence interval, 1.09-3.18; P = .022) (hazard ratio, 1.73; confidence interval, 1.13-2.73; P = .010). ConclusionsSutureless valves improved the outcomes of aortic stenosis in elderly patients with an intermediate risk profile when compared with transcatheter aortic valve implantation. The use of transcatheter aortic valve implantation in this subset population should be evaluated in further controlled randomized trials with sutureless valve use in a comparative cohort.

Clinical impact of peripherally inserted central catheters vs implanted port catheters in patients with cancer: an open-label, randomised, two-centre trial

BackgroundCentrally inserted totally implanted vascular access ports (PORTs) and peripherally inserted central catheters (PICCs) are widely used for the administration of chemotherapy. Our aim was to study the incidence of catheter-related deep venous thrombosis in patients with cancer receiving chemotherapy through either a PICC or a PORT. MethodsAdults with non-haematological cancer (mainly breast and colorectal) from two Swedish oncology centres were included and followed for up to 1 yr. Patients were randomly assigned to receive a single-lumen PICC or PORT. The primary end point was the occurrence of a clinically significant catheter-related deep venous thrombosis, and the secondary end point was a composite of adverse events related to the catheter: insertion complication, thrombosis, occlusion, infection, and mechanical problems. ResultsThe trial recruited 399 participants (PICC, n=201; PORT, n=198) between March 2013 and February 2017. The PICCs were associated with 16 (8%) deep venous thromboses compared with two (1%) in the PORT group (HR=10.2; 95% confidence interval, 2.3–44.6; P=0.002). The overall incidence of composite adverse events was higher for patients with a PICC compared with those with a PORT (HR=2.7; 95% confidence interval, 1.6–4.6; P<0.001). ConclusionsPICCs are associated with higher risk for catheter-related deep venous thrombosis and other adverse events when compared with PORTs. This increased risk should be considered when choosing a vascular access device for chemotherapy, especially in patients with solid malignancy. Clinical trial registrationNCT01971021.

RF43 LONG-TERM FOLLOW-UP OF SUTURELESS VERSUS TRANSCATHETER AORTIC VALVE IN ELDERLY PATIENT WITH AORTIC STENOSIS AT INTERMEDIATE RISK: THE EUROPEAN MULTI-INSTITUTIONAL STUDY

Background and Aim: This multi-institutional European study compares the long-term outcome of elderly patients with severe aortic stenosis at intermediate risk profile undergoing sutureless (SV) versus Transcatheter (TAVR) aortic valve implant. Methods: From 2008 to 2015, 967 elderly patients (&gt;75 years old) at intermediate risk (STS score 4%-8%) and isolated aortic stenosis entered the study (SV = 481/TAVR = 486). After full matching Propensity Score, two matched groups of 470 (G1) and 468 (G2) patients were obtained. Primary endpoints included all-causedeath at 30-days and at 5-years. Secondary endpoints included early and 5-years incidence of composite adverse events (MACCEs: all-cause death, stroke, PM implant, MI, paravalvular leak ≥ 2 + , re-operation). Results: After matching there were no difference in major variables between groups. The 30-days mortality was significantly lower in SV group (G1 = 1.7% vs G2 = 6.2%;p = 0.006) as well as permanent PM implantation (G1 = 5.5% vs G2 = 11.7%,p = 0.004). Stroke/TIA cumulative incidence at five years was 1.7% (G1) and 4.8% (G2)(p = 0.020). Incidence of perivalvular leak ≥ grade II was in 0.85% in G1 and 7.4% in G2 (p &lt; 0.001). At mean follow-up of 60 months, overall mortality and the incidence of MACCEs were significantly better in patients undergoing SV (G1 = 14.4 ± 2.7% vs G2 = 30.7 ± 3.3% p &lt; 0.001) (G1 = 20.9 ± 4.9% vs G2 = 43.3 ± 5.1%,p &lt; 0.001). Multivariable Cox Regression identified TAVR as independent predictor for mortality and MACCEs at 5-years (HR = 2.1,CI = 1.12-4.17,p = 0.002) (HR 2.9, CI:1.6-4.3, p &lt; 0,001). Conclusion: Sutureless rapid deployment valves improved the outcomes of aortic stenosis elderly patients at intermediate risk profile. The use of TAVR in this subset population should be evaluated in further controlled randomized trial having sutureless valve as comparative cohort.

Prognostic implication of macrocytosis on adverse outcomes after coronary intervention

BackgroundMacrocytosis, as a qualitative abnormality of erythrocytes, has not drawn attention as a prognostic indicator after PCI, while anemia, as a quantitative abnormality of erythrocytes, has been recognized as a predictor of adverse outcomes. The aim of this study was to perform prognostic risk stratification of patients after PCI based on the presence or absence of macrocytosis. MethodsThe clinical records of 941 consecutive patients who underwent PCI at a single institution were retrospectively reviewed. The prognostic implication of macrocytosis was evaluated by univariate and multivariate Cox's proportional hazard regression analysis. ResultsThere were 130 (13.8%) patients with macrocytosis. A significantly higher all-cause and cardiac mortality, as well as incidence of composite adverse events were observed in the Macrocytic group. Kaplan–Meier analysis also showed a significantly poorer overall survival in patients with macrocytosis. Even after exclusion of anemic patients, this tendency was still observed. Furthermore, macrocytosis was significantly and independently associated with adverse outcomes after PCI (aHR of cardiac death: 3.45, 95%CI: 1.22–9.80, P=0.019). Interestingly, fewer patients with macrocytosis were prescribed statins compared with those without it (33.8% vs. 47.1%, P=0.005). ConclusionsThe results of the study indicate that measuring mean corpuscular volume (MCV) as a qualitative index of erythrocytes might be helpful for a prognostic risk stratification of patients subjected to PCI.