Long-term Adverse Events Research Articles

Risk Prediction Models for Ischemic Cardiovascular Outcomes in Patients with Acute Coronary Syndrome.

Acute coronary syndrome (ACS) has a high incidence of adverse cardiovascular events, even after early invasive treatment. Patients may still have a poor prognosis after discharge. The keys to the long-term survival of patients with ACS include effective treatment in a timely manner and identification of those patients who are at higher risk for long-term adverse events. Therefore, several nations have now devised a range of risk assessment models to provide data for accurately formulating treatment plans for patients with various risk levels following an ACS to prevent short and long-term cardiovascular events. The purpose of this article is to review the risk scores associated with mortality and ischemic events in patients with ACS. By using the clinical risk prediction score, we can accurately and effectively judge the prognosis of patients, so as to take a more reasonable treatment.

Safety of mRNA Vaccines Administered During the First Twenty-Four Months of the International COVID-19 Vaccination Program

Two mRNA-based COVID vaccines were granted emergency use authorization in both children and adults in 2021 after a drastically accelerated approval process that allowed the manufacturers to essentially fast-track their vaccines. We analyzed data from regulatory surveillance and self-reporting systems like Defense Medical Epidemiology Database(DMED); EudraVigilance; Eurostat; German health insurers; the Israeli Minister of Health; the Natural Cycles app; Public Health Scotland; the United Kingdom’s (UK) Office for National Statistics (ONS); UK’s yellow card reporting system; the vaccine adverse event reporting system (VAERS); and v-safe entries to look for long-term adverse events of these vaccines that cannot be captured in the expedited clinical safety trials. In this observational study, we analyzed non-foreign VAERS data for selected symptoms reported after COVID, influenza, and pertussis vaccines and calculated rates per vaccine dose administered as well as proportion of total reports received. We also looked at DMED data and compared annual incidence rates of selected conditions by taking into account the total number of military personnel for each study year. Our data show, among other trends, increases in adverse event reports if we compare COVID vaccines to influenza and pertussis vaccines and statistically significant higher numbers of hospital encounters in military personnel, as well as increases in incidences of thromboembolic conditions, such as menstrual abnormalities, myocarditis, and cerebrovascular events after the implementation of COVID vaccine mandates, compared to the five years prior. We verified these observations using data from EudraVigilance; the UK’s ONS; German health providers; and Eurostat. Our meta-analysis of both national and international vaccine adverse events emphasizes the importance of re-evaluating public health policies that promote universal mass vaccination and multiple boosters for all demographic groups. In combination with anecdotal evidence, limitations of the safety trials, and the decreased lethality of new strains our research demonstrates that the cost (both monetary and humanitarian) of vaccinating otherwise healthy people, and especially children, may outweigh the benefits.

The natural history of QTc interval and its clinical impact in coronavirus disease 2019 survivors after 1 year.

Prolonged QTc interval on admission and a higher risk of death in SARS-CoV-2 patients have been reported. The long-term clinical impact of prolonged QTc interval is unknown. This study examined the relationship in COVID-19 survivors of a prolonged QTc on admission with long-term adverse events, changes in QTc duration and its impact on 1-year prognosis, and factors associated with a prolonged QTc at follow-up. We conducted a single-center prospective cohort study of 523 SARS-CoV-2-positive patients who were alive on discharge. An electrocardiogram was taken on these patients within the first 48 h after diagnosis and before the administration of any medication with a known effect on QT interval and repeated in 421 patients 7 months after discharge. Mortality, hospital readmission, and new arrhythmia rates 1 year after discharge were reviewed. Thirty-one (6.3%) survivors had a baseline prolonged QTc. They were older, had more cardiovascular risk factors, cardiac disease, and comorbidities, and higher levels of terminal pro-brain natriuretic peptide. There was no relationship between prolonged QTc on admission and the 1-year endpoint (9.8% vs. 5.5%, p = 0.212). In 84% of survivors with prolonged baseline QTc, it normalized at 7.9 ± 2.2 months. Of the survivors, 2.4% had prolonged QTc at follow-up, and this was independently associated with obesity, ischemic cardiomyopathy, chronic obstructive pulmonary disease, and cancer. Prolonged baseline QTc was not independently associated with the composite adverse event at 1 year. Prolonged QTc in the acute phase normalized in most COVID-19 survivors and had no clinical long-term impact. Prolonged QTc at follow-up was related to the presence of obesity and previously acquired chronic diseases and was not related to 1-year prognosis.

664 Use of Local Surgical Site Morselized Autograph to Perform Minimally Invasive Transforaminal Lumbar Interbody Fusion to Improve Outcome

INTRODUCTION: MI-TLIF has become one of the primary approaches for treating refractory low back pain. Patient outcomes are related to fusion rates. A critical analysis of the impact of surgical site morselized autograph bone (MAB) on patient reported outcomes undergoing MI-TLIF has not been analyzed. METHODS: A retrospective analysis of 215 patients who underwent MI-TLIF using MAB. Variables analyzed included age, gender, follow-up period, comorbidities, number/levels of stenosis, estimated blood loss, surgical time, complications in the immediate postoperative period, clinical scales including VAS (Visual Analogue Scale), ODI (Oswestry Disability Index) at 3, 6, 12, 24 -months. RESULTS: Average age was 63.8±12.7 years and average BMI was 29.4±6.1 kg/m2 with average follow-up 19.4+/-11.4 months. Co-morbidities included: diabetes (n=34 (15.8%)) and current or former smoker (n = 61 (28.4%)). Pathogy treated included 156 patients with spondylolisthesis (n = 139, grade 1; n = 17, grade 2) and 122 patients with concomitant stenosis with grade 1(n = 20), 2(n = 15), and 3(n = 87). No major operative adverse events were noted, with 2 patients with postoperative infections. Postoperative VAS showed statistically significant improvements at 3 weeks, 1 year, and 2 years compared to baseline levels (p < 0.00001 for all). Improvements in ODI scores were statistically significant compared to baseline at 3 months (p = 0.03) and 2 years (p = 0.016). Of the 54 patients that had comorbid scoliosis, Cobb angle improved from 20±10.6 preoperatively to 16 ± 10.5 postoperatively (p = 0.27). No long-term adverse events occurred. Fusion rate was greater than 95%. CONCLUSIONS: MI-TLIF using MAB was highly cost effective, had low complication rates, and significantly improved patient reported outcomes.

Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Stroke: 2- and 3-Year Follow-up From the Pilot Study

ObjectiveTo assess whether a long-term home-based intervention using Paired VNS therapy is feasible and whether the benefits of Paired VNS therapy are maintained beyond 1 year. DesignA long-term follow-up study. SettingThree centers in the United States and 1 in the United Kingdom. ParticipantsAdults with chronic ischemic stroke (n=15) with moderate to severe arm and hand impairment. InterventionsParticipants were implanted with a VNS device followed by 6 weeks of in-clinic therapy with Paired (Active) or control VNS followed by home-based rehabilitation through day 90 (blinded phase). The control VNS group then crossed over to receive 6 weeks of in-clinic Active VNS. Participants in both groups then continued a long-term home exercise program with self-administered Active VNS. Main Outcome MeasuresFugl-Meyer Assessment for Upper Extremity (FMA-UE) and Wolf Motor Function Test (WMFT) Functional scores were evaluated at the end of in-clinic therapy and day 90. Since both groups were subsequently receiving home-based rehabilitation with Active VNS during the long term, follow-up outcome assessments were pooled for the analyses at 6, 9, and 12 months, as previously reported. Here, we report pooled analysis of outcomes beyond 1 year. ResultsOne year after Paired VNS therapy, FMA-UE improved by an average of 9.2±8.2 points, as previously reported. Overall, the 2- and 3-year FMA-UE gain from baseline was 11.4±8.7 (P<.001) and 14.8±10.2 points (P<.001), respectively. At years 2 and 3, FMA-UE improved by an additional 2.9 (P=.03 for change vs year 1, n=14) and 4.7 (P=.02 for change vs year 1, n=14) points, respectively. At year 1, 73% (11/15) of participants were responders (FMA-UE change ≥6) and by year 3, 85.7% (12/14) were responders. At years 2 and 3, the WMFT score improved by an additional 0.21 points (P=.03 for change vs year 1, n=15) and 0.42 points (P=.01 for change vs year 1, n=13), respectively. Responder rate (WMFT change ≥0.4) was 46.6% (7/15), 73.3% (11/15), and 69.2% (9/13) at years 1, 2, and 3, respectively. Long-term significant improvements were also observed for Motor Activity Log (MAL) and Stroke Impact Scale, Hand section (SIS-Hand). There were no serious long-term adverse events from the stimulation. ConclusionsSignificant effects of Paired VNS therapy at 1 year were maintained at years 2 and 3, and further improvements in both impairment and function were observed in years 2 and 3. These changes were associated with improvements in measures of activity and participation.

Left ventricular remodeling and long-term outcomes of aortic stenosis patients receiving 19mm Mosaic.

Mosaic valve shows higher pressure gradient after aortic valve replacement compared to other same size labeled prostheses in postoperative echocardiogram. The purpose of this study was to evaluate the mid-term echocardiogram findings and long-term clinical outcomes of patients receiving a 19mm Mosaic. Forty-six aortic stenosis patients receiving 19mm Mosaic and 112 patients receiving either 19mm Magna or Inspiris, who underwent mid-term follow-up echocardiogram were included in the study. Mid-term hemodynamic measurements evaluated by trans-thoracic echocardiogram and long-term outcomes were compared. Patients receiving Mosaic were significantly older (Mosaic: 76 ± 5.1years vs. Magna/Inspiris: 74 ± 5.5years, p = 0.046) and had smaller body surface area (Mosaic: 1.40 ± 0.114m2 vs. Magna/Inspiris: 1.48 ± 0.143m2, p < 0.001). There were no significant differences in comorbidities and medications. Post-operative echocardiogram performed at 1week after the surgery showed higher maximum pressure gradient in patients receiving Mosaic (Mosaic: 38 ± 13.5mmHg vs. Magna/Inspiris: 31 ± 10.7mmHg, p = 0.002). Furthermore, mid-term echocardiogram follow-up performed at median duration of 53 ± 14.9months after the surgery continuously showed higher maximum pressure gradient in patients receiving Mosaic (Mosaic: 45 ± 15.6mmHg vs. Magna/Inspiris: 32 ± 13.0mmHg, p < 0.001). However, there were no significant difference in changes in left ventricular mass from baseline in both groups. Kaplan-Meyer curve also showed no difference in long-term mortality and major adverse cardiac and cerebrovascular event between the two groups. Although the pressure gradient across the valve evaluated by echocardiogram was higher in 19mm Mosaic compared to 19mm Magna/Inspiris, there were no significant differences in left ventricular remodeling and long-term outcomes between the two groups.

Impact of chemotherapy on surgical outcomes in ileostomy reversal: a propensity score matching study from a single centre.

In patients with chemotherapy, there is no consensus on the timing of ileostomy closure. Ileostomy reversal could improve the quality of life and minimise the long-term adverse events of delayed closure. In this study, we evaluated the impact of chemotherapy on ileostomy closure and searched for the predictive factors for complications. We retrospectively analysed 212 patients with rectal cancer who underwent ileostomy closure surgery during and without chemotherapy and were consecutively enrolled between 2010 and 2016. As a result of the heterogeneity of the two groups, propensity score matching (PSM) was performed with a 1:1 PSM cohort. A total of 162 patients were included in the analysis. The overall stoma closure-related complications (12.4% vs. 11.1%, p = 1.00) and major complications (2.5% vs. 6.2%, p = 0.44) were not significantly different between the two groups. Multivariate analysis demonstrated that chronic kidney disease and bevacizumab use are risk factors for major complications. Patients with oral or intravenous chemotherapy can safely have ileostomy closure with an adequate time delay from chemotherapy. When patients use bevacizumab, major complications related to ileostomy closure should still be cautioned.

Randomized Placebo Controlled Trial of Low-Dose Tamoxifen to Prevent Recurrence in Breast Noninvasive Neoplasia: A 10-Year Follow-Up of TAM-01 Study.

Five-year data of the phase III trial TAM-01 showed that low-dose tamoxifen at 5 mg once daily administered for 3 years in women with intraepithelial neoplasia (IEN) reduced by 52% the recurrence of invasive breast cancer or ductal carcinoma in situ (DCIS), without additional adverse events over placebo. Here, we present the 10-year results. We randomly assigned 500 women with breast IEN (atypical ductal hyperplasia, lobular carcinoma in situ [LCIS], or hormone-sensitive or unknown DCIS) to low-dose tamoxifen or placebo after surgery with or without irradiation. The primary end point was the incidence of invasive breast cancer or DCIS. The TAM-01 population included 500 women (20% atypical ductal hyperplasia, 11% LCIS, and 69% DCIS). The mean (±SD) age at the start of treatment was 54 ± 9 years, and 58% of participants were postmenopausal. After a median follow-up of 9.7 years (IQR, 8.3-10.9 years), 66 breast cancers (15 in situ; 51 invasive) were diagnosed: 25 in the tamoxifen group and 41 in the placebo group (annual rate per 1,000 person-years, 11.3 with tamoxifen v 19.5 with placebo; hazard ratio [HR], 0.58; 95% CI, 0.35 to 0.95; log-rank P = .03). Most recurrences were invasive (77%) and ipsilateral (59%). Regarding contralateral breast cancer incidence, there were six events in the tamoxifen arm and 16 in the placebo arm (HR, 0.36; 95% CI, 0.14 to 0.92; P = .025). The number needed to be treated to prevent one case of breast event with tamoxifen therapy was 22 in 5 years and 14 in 10 years. The benefit was seen across all patient subgroups. There was a significant 50% reduction of recurrence with tamoxifen in the DCIS cohort, which represents 70% of the overall population (HR, 0.50; 95% CI, 0.28 to 0.91; P = .02). No between-group difference in the incidence of serious adverse events was reported during the prolonged follow-up period. Tamoxifen 5 mg once daily for 3 years significantly prevents recurrence from noninvasive breast cancer after 7 years from treatment cessation without long-term adverse events.

Autologous fat grafting to the paravertebral space seems to prevent the postherpetic neuralgia-A single-arm pilot study.

Postherpetic neuralgia (PHN) is one of the most common complications of Herpes zoster (HZ), yet the mechanism and the treatment for PHN remains elusive. We first performed this feasibility study to verify the safety and efficiency of autologous fat grafting into the paravertebral space in early HZ to prevent PHN. Patients suffering from HZ with a rash in chest, back, or abdomen were arranged for autologous fat grafting to the paravertebral space. The primary endpoint was the incidence of PHN, which was defined as persistence pain in the affected dermal area in 12weeks after fat grafting. Secondary endpoints including patient-reported changes in pain intensity, assessed pain threshold and the quality of life during follow-ups. Eight patients accept the intervention and completed all follow-ups. Most patients report immediate pain relief after injection, one patient has a mild to moderate dizzy symptom after injection. No other short- or long-term adverse events occurred. For primary outcome, all patients have a timely reduced pain intensity, with no PHN events occurred, as all patients report pain intensity ≤3 in the VAS scale in 3 months after treatment. For electrical pain threshold, we identify that fat grafting differentially increases sensation and pain threshold in HZ area and healthy skin of patients. Besides, our results indicate significant improvement in patients' life quality decrease in analgesic consumption. Autologous fat transplantation to the paravertebral space is a safe and feasible technique in preventing PHN from HZ in a rash. Further randomized controlled trial to investigate the actual long-term benefice of autologous fat grafting to the paravertebral space in preventing PHN is needed. ChiCTR, (ChiCTR1900025416); registered August 26, 2019.

Efficacy of a novel polyoxazoline-based hemostatic patch in liver and spleen surgery

BackgroundA new hemostatic sealant based on a N-hydroxy-succinimide polyoxazoline (NHS-POx) polymer was evaluated to determine hemostatic efficacy and long-term wound healing and adverse effects in a large animal model of parenchymal organ surgical bleeds.MethodsExperiment 1 included 20 pigs that were treated with two NHS-POx patch prototypes [a gelatin fibrous carrier (GFC) with NHS-POx and an oxidized regenerated cellulose (ORC) with poly(lactic-co-glycolic acid)-NHS-POx:NU-POx (nucleophilically activated polyoxazoline)], a blank gelatin patch (GFC Blank), TachoSil® and Veriset™ to stop moderate liver and spleen punch bleedings. After various survival periods (1–6 weeks), pigs were re-operated to evaluate patch degradation and parenchymal healing. During the re-operation, experiment 2 was performed: partial liver and spleen resections with severe bleeding, and hemostatic efficacy was evaluated under normal and heparinized conditions of the two previous prototypes and one additional NHS-POx patch. In the third experiment an improved NHS-POx patch (GATT-Patch; GFC-NHS-POx and added 20% as nucleophilically activated polyoxazoline; NU-POx) was compared with TachoSil®, Veriset™ and GFC Blank on punch bleedings and partial liver and spleen resections for rapid (10s) hemostatic efficacy.ResultsNHS-POx-based patches showed better (GFC-NHS-POx 83.1%, ORC-PLGA-NHS-POx: NU-POx 98.3%) hemostatic efficacy compared to TachoSil® (25.0%) and GFC Blank (43.3%), and comparable efficacy with Veriset™ (96.7%) on moderate standardized punch bleedings on liver and spleen. All patches demonstrated gradual degradation over 6 weeks with a reduced local inflammation rate and an improved wound healing. For severe bleedings under non-heparinized conditions, hemostasis was achieved in 100% for Veriset™, 40% for TachoSil and 80–100% for the three NHS-POx prototypes; similar differences between patches remained for heparinized conditions. In experiment 3, GATT-Patch, Veriset™, TachoSil and GFC Blank reached hemostasis after 10s in 100%, 42.8%, 7.1% and 14.3%, respectively, and at 3 min in 100%, 100%, 14.3% and 35.7%, respectively, on all liver and spleen punctures and resections.ConclusionsNHS-POx-based patches, and particularly the GATT-Patch, are fast in achieving effective hemostatic sealing on standardized moderate and severe bleedings without apparent long-term adverse events.

Comparison of Long-Term Clinical Outcomes of Elective Percutaneous Coronary Intervention Between Complex and High-risk Intervention in Indicated Patients (CHIP) versus Non-CHIP

Recently, there has been a growing interest in complex and high-risk intervention in indicated patients (CHIP) in the contemporary percutaneous coronary intervention (PCI). CHIP is composed of the following 3 factors: (1) patient factors, (2) complicated heart disease, and (3) complex PCI. However, there are few studies that investigated the long-term outcomes of CHIP-PCI. The purpose of this study was to compare the incidence of long-term major adverse cardiovascular events (MACEs) among the definite CHIP, possible CHIP, and non-CHIP groups in complex PCI. We included 961 patients and divided them into the definite CHIP (n=129), the possible CHIP (n=369), and the non-CHIP groups (n=463). During the median follow-up duration of 573days (quartile 1:226 days to quartile 3:1,165 days), a total of 189 MACE were observed. The incidence of MACE was highest in the definite CHIP group, followed by the possible CHIP group, and lowest in the non-CHIP group (p=0.001). Definite CHIP (vs non-CHIP: odds ratio 3.558, 95% confidence interval 2.249 to 5.629, p <0.001) and possible CHIP (vs non-CHIP: odds ratio 2.260, 95% confidence interval 1.563 to 3.266, p <0.001) were significantly associated with MACE after controlling for confounding factors. Among CHIP factors, active malignancy, pulmonary disease, hemodialysis, unstable hemodynamics, left ventricular ejection fraction, and valvular disease were significantly associated with MACE. In conclusion, the incidence of MACE in complex PCI was highest in the definite CHIP group, followed by the possible CHIP group, and lowest in the non-CHIP group. The concept of CHIP should be recognized to predict the long-term MACE in patients who undergo complex PCI.

Adjustment of the GRACE score by the stress hyperglycemia ratio improves the prediction of long-term major adverse cardiac events in patients with acute coronary syndrome undergoing percutaneous coronary intervention: A multicenter retrospective study

AimsThe predictive value of the stress hyperglycemia ratio (SHR) for long-term prognosis in acute coronary syndrome (ACS) is inconsistent. Whether the SHR provides additional prognostic value in addition to the GRACE score in ACS patients undergoing percutaneous coronary intervention (PCI) remains unknown. MethodsA development–validation method was adopted to develop an algorithm to adjust the GRACE score using the SHR in ACS patients undergoing PCI from 11 hospitals. ResultsDuring a median follow-up of 31.33 months, the occurrence of major adverse cardiac events (MACEs), defined as a composite of all-cause mortality and nonfatal myocardial infarction, was more frequent in the patients with a higher level of SHR. The SHR independently predicted long-term MACEs (hazard ratio 3.3479; 95% CI 1.4103–7.9475; P = 0.0062). Adjustment of the GRACE risk by addition of the SHR increased the C-statistic from 0.706 (95% CI: 0.599–0.813) to 0.727 (95% CI: 0.616–0.837) (P < 0.01), with a continuous net reclassification improvement of 30.5% and an integrated discrimination improvement of 0.042 (P < 0.01) in the derivation cohort; and addition of the SHR showed superior discrimination and good calibration in the validation cohort. ConclusionsThe SHR is an independent predictor of long-term MACEs in ACS patients undergoing PCI and markedly improves the performance of the GRACE score.

Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention of the Left Anterior Descending Artery

The left anterior descending artery (LAD) subtends a large myocardial territory. The outcomes of LAD chronic total occlusion (CTO) percutaneous coronary intervention (PCI) have received limited study. We performed a retrospective analysis of all patients who underwent LAD CTO PCI at a high-volume single center. Outcomes included in-hospital and long-term major adverse cardiovascular events (MACEs) and changes in left ventricular ejection fraction (LVEF). We performed a subgroup analysis of patients with ischemic cardiomyopathy, defined as an LVEF of 40% or less. From December 2014 to February 2021, 237 patients underwent LAD CTO PCI. The technical success rate was 97.4%, and the in-hospital MACE rate was 5.4%, A landmark analysis after hospital discharge showed an overall survival of 92% and 85% MACE-free survival at 2years. There was no difference in overall survival or MACE-free survival between those who had ischemic cardiomyopathy versus those who did not. In patients with ischemic cardiomyopathy, LAD CTO PCI was associated with significant improvement in LVEF (10.9% at 9months), which was further pronounced when these patients had a proximal LAD CTO and were on optimal medical therapy (14% at 6months). In a single high-volume center, LAD CTO PCI was associated with 92% overall survival at 2years, with no difference in survival between patients with or without ischemic cardiomyopathy. LAD CTO PCI was associated with an absolute 10% increase in LVEF at 9months in patients with ischemic cardiomyopathy.

R2CHA2DS2-VA Predictsthe Cardiovascular Risk after Carotid Endarterectomy

R2CHA2DS2-VA score has been used to predict short and long-term outcomes in many cardiovascular diseases. This study aims to validate the R2CHA2DS2-VA score as a long-term major adverse cardiovascular events (MACE) predictor after carotid endarterectomy (CEA). Secondary outcomes were also assessed regarding the incidence of all-cause mortality, acute myocardial infarction (AMI), major adverse limb events (MALE), and acute heart failure (AHF). From January 2012 to December 2021, patients (n=205) from a Portuguese tertiary care and referral center that underwent CEA with regional anesthesia (RA) for carotid stenosis (CS) were selected from a previously collected prospective database, and a posthoc analysis was performed. Demographics and comorbidities were registered. Clinical adverse events were assessed 30 days after the procedure and in the subsequent long-term surveillance period. Statistical analysis was performed by the Kaplan-Meier method and Cox proportional hazards regression. Of the patients enrolled, 78.5% were males with a mean age of 70.44±8.9years. Higher scores of R2CHA2DS2-VA were associated with long-term MACE (adjusted hazard ratio (aHR) 1.390; 95% confidence interval (CI) 1.173-1.647); and mortality (aHR 1.295; 95% CI 1.08-1.545). This study demonstrated the potential of the R2CHA2DS2-VA score to predict long-term outcomes, such as AMI, AHF, MACE, and all-cause mortality, in a population of patients submitted to carotid endarterectomy.

The association of preoperative high-sensitivity cardiac troponin i and long-term outcomes in colorectal cancer patients received tumor resection surgery

BackgroundThis study aimed to evaluate the association between preoperative hs-cTnI and long-term mortality and major adverse cardiovascular events (MACE) in colorectal cancer patients.MethodsThis single-center retrospective cohort study included 1105 consecutive colorectal cancer patients who received tumor resection surgery between January 2018 and June 2020. Inclusion criteria were an age ≥ 18 years and had been tested for hs-cTnI on admission within 7 days prior to tumor resection surgery. Exclusion criteria were emergent surgery, failure to received tumor resection surgery, hospital death, there was clinical evidence of unstable coronary artery disease or pulmonary embolism occurred before operation according to medical record. The primary endpoint was all-cause death. Secondary endpoint was major adverse cardiovascular events (MACE).ResultsA total of 1105 patients were enrolled: 1032 with normal hs-cTnI and 73 with elevated hs-cTnI. The mean follow-up was 24.4 ± 10.8 months, 176 patients died and 39 patients met MACE. In the elevated troponin group, 50%, 32.1% and 17.9% died from cancer, cardiovascular and other causes, while those in the normal troponin group were 75.7%, 2% and 22.3%, there was statistical difference between 2 groups (P < 0.001). Patients with elevated preoperative hs-cTnI had significantly higher mortality (P < 0.001) and more MACE (P < 0.001) compared with those with normal hs-cTnI. A propensity-matching analysis were performed, resulting in 151 patients with normal hs-cTnI and 60 patients with elevated hs-cTnI. The matched population had the similar results for all-cause death (P = 0.009) and MACE (P = 0.001). The results were consistent after further excluding 147 patients who had received chemoradiotherapy prior to surgery in subgroup analysis. The results of multivariate Cox regression analysis shown that hs-cTnI was one of the best predictors for all-cause death (hazard ratio [HR] 2.278; 95% confidence interval [CI] 1.19–4.361) and MACE (HR, 3.523; 95%CI, 1.477–8.403) in total populations, similar results were found in subgroup analysis.ConclusionsColorectal cancer patients without myocardial ischemia manifestation but with elevated hs-cTnI prior to tumor resection surgery were at increased risk for long-term all-cause death and MACE, irrespective of whether they have received chemoradiotherapy prior to surgery.

Long-Term Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention Among Medicare Beneficiaries.

Chronic total occlusion (CTO) percutaneous coronary interventions (PCIs) represent 4% of all PCIs for stable angina in the United States and have been associated with lower success and higher in-hospital event rates compared with non-CTO PCIs. We aimed to examine long-term outcomes of CTO PCI compared with non-CTO PCI, including prespecified subgroups of high-risk non-CTO PCI (atherectomy/saphenous vein graft/unprotected left main). Among 551,722 patients in the National Cardiovascular Data Registry CathPCI Registry linked to Medicare (July 2009-December 2016), we evaluated in-hospital events and long-term major adverse cardiovascular events of CTO PCIs (N = 29,407) compared with non-CTO PCIs (N = 522,315). We then evaluated similar outcomes between CTO PCIs and high-risk non-CTO PCIs (N = 53,662). We excluded patients with ST-elevation myocardial infarction and non-ST-elevation myocardial infarction. Patients undergoing CTO PCI were more likely to be younger and male. CTO PCI was associated with a higher risk of in-hospital events compared with non-CTO PCI (7.0% vs 4.2%; P < .001) and high-risk non-CTO PCI (7.0% vs 6.5%; P = .008). In addition, CTO PCI was associated with a slightly higher risk of long-term repeat revascularization compared with non-CTO PCI (adjusted hazard ratio [aHR], 1.09; 95% CI, 1.05-1.13). However, compared with high-risk non-CTO PCIs, CTO PCIs were associated with a slightly lower risk of long-term major adverse cardiovascular events (aHR, 0.87; 95% CI, 0.84-0.90) and readmission (aHR, 0.87; 95% CI, 0.84-0.90). In this study, CTO PCI was associated with higher risk of both in-hospital and out-of-hospital events but a slightly lower risk of long-term events compared with high-risk non-CTO PCIs. These findings shed light on the complexity of various PCI procedures that can inform clinicians and patients of expected outcomes.

Exploring the Pipeline of Novel Therapies for Inflammatory Bowel Disease; State of the Art Review.

Crohn's disease (CD) and ulcerative colitis (UC), known as inflammatory bowel diseases (IBD), are characterized by chronic inflammation of the gastrointestinal tract. Over the last two decades, numerous medications have been developed and repurposed to induce and maintain remission in IBD patients. Despite the approval of multiple drugs, the major recurring issues continue to be primary non-response and secondary loss of response, as well as short- and long-term adverse events. Most clinical trials show percentages of response under 60%, possibly as a consequence of strict inclusion criteria and definitions of response. That is why these percentages appear to be more optimistic in real-life studies. A therapeutic ceiling has been used as a term to define this invisible bar that has not been crossed by any drug yet. This review highlights novel therapeutic target agents in phases II and III of development, such as sphingosine-1-phosphate receptor modulators, selective Janus kinase inhibitors, anti-interleukins, and other small molecules that are currently under research until 1 January 2023. Emerging treatments for CD and UC that have just received approval or are undergoing phase III clinical trials are also discussed in this review.

The long-term adverse events and persisting clinical symptomatology post COVID-19 infection among the healthcare workers of a tertiary care hospital in West Bengal

COVID -19, a global pandemic, has dominated every person’s life worldwide. The clinical presentation of COVID-19 ranges from asymptomatic, mild symptomatic to fulminant and fatal cases, having consequences for many organ systems. In a cross-sectional study, 128 healthcare workers of a tertiary care medical college hospital, 4 weeks following the COVID infection agreed to participate in the study. Self-developed subject data sheet and the self-reporting symptoms tool based on the WHO case report form were used for data collection. A significant number of health care workers (HCWs) had long COVID symptomatology in terms of constitutional, muscular-skeletal, respiratory, otolaryngology, and CNS symptoms. The commonly experienced symptoms were myalgia (45.3%), malaise (39%), fatigue and tiredness (69.5%), loss of taste (21.1%), loss of smell (20.3%) and night sweats (11.7%), lack of sleep (20.3%), and anxiety (12.5%). The cardiovascular and integumentary were the less affected organ systems. About one-third of the HCWs reported that symptoms like myalgia, malaise and tiredness got worse after physical activity (29.7%). Aggravation of symptoms with any form of mental activity was reported in 11.7% of the study participants. One in every ten HCWs (12.5%) had reported not being able to perform daily activities that they were doing before getting COVID-19 infection. However, all resumed their job after the recovery. Long COVID symptoms were reported by a significant number of HCWs, necessitating the need for the establishment of follow-up clinics for the care of healthcare workers.

Minimally Invasive Direct Coronary Artery Bypass Versus Percutaneous Coronary Intervention for Isolated Left Anterior Descending Artery Stenosis: An Updated Meta-Analysis.

The optimal revascularization strategy for isolated left anterior descending (LAD) coronary artery lesion between minimally invasive direct coronary artery bypass (MIDCAB) and percutaneous coronary intervention (PCI) remains controversial. This updated meta-analysis aims to compare the long- and short-term outcomes of MIDCAB versus PCI for patients with isolated LAD coronary artery lesions. The Pubmed, Web of Science, and Cochrane databases were searched for retrieving potential publications from 2002 to 2022. The primary outcome was long-term survival. Secondary outcomes were long-term target vessel revascularization (TVR), long-term major adverse cardiovascular events (MACEs), and short-term outcomes, including postoperative mortality, myocardial infarction (MI), TVR, and MACEs of any cause in-hospital or 30 days after the revascularization. Six randomized controlled trials (RCTs) and eight observational studies were included in this updated meta-analysis. In total, 1757 patients underwent MIDCAB and 15245 patients underwent PCI. No statistically significant difference was found between the two groups in the rates of long-term survival. MIDCAB had a lower long-term MACE rate compared with PCI. Besides, PCI resulted in an augmented risk of TVR. Postoperative mortality, MI, TVR, and MACEs were similar between the two groups. The updated meta-analysis presents the evidence that MIDCAB has a reduced risk of long-term TVR and MACEs, with no benefit in terms of long-term mortality and short-term results, in comparison with PCI. Large multicenter RCTs, including patients treated with newer techniques, are warranted in the future.

Comparison of the real-life clinical outcomes of warfarin with effective time in therapeutic range and non-vitamin K antagonist oral anticoagulants: Insight from the AFTER-2 trial.

It is unclear whether warfarin treatment with high time in therapeutic range (TTR) is as effective and safe as non-vitamin K antagonist oral anticoagulants (NOACs). It is crucial to compare warfarin with effective TTR and NOACs to predict long-term adverse events in patients with atrial fibrillation. We aimed to compare the long-term follow-up results of patients with atrial fibrillation (AF) who use vitamin K antagonists (VKAs) with effective TTR and NOACs. A total of 1140 patients were followed at 35 different centers for five years. During the follow-up period, the international normalized ratio (INR) values were studied at least 4 times a year, and the TTR values were calculated according to the Roosendaal method. The effective TTR level was accepted as >60% as recommended by the guidelines. There were 254 patients in the effective TTR group and 886 patients in the NOAC group. Ischemic cerebrovascular disease/transient ischemic attack (CVD/TIA), intracranial bleeding, and mortality were considered primary endpoints based on one-year and five-year follow-ups. Ischemic CVD/TIA (3.9% vs. 6.2%; P = 0.17) and intracranial bleeding (0.4% vs. 0.5%; P = 0.69), the one-year mortality rate (7.1% vs. 8.1%; P = 0.59), the five-year mortality rate (24% vs. 26.3%; P = 0.46) were not different between the effective TTR and NOACs groups during the follow-up, respectively. The CHA2DS2-VASC score was similar between the warfarin with effective TTR group and the NOAC group (3 [2-4] vs. 3 [2-4]; P = 0.17, respectively). Additionally, survival free-time did not differ between the warfarin with effective TTR group and each NOAC in the Kaplan-Meier analysis (dabigatran; P = 0.59, rivaroxaban; P = 0.34, apixaban; P = 0.26, and edoxaban; P = 0.14). There was no significant difference in primary outcomes between the effective TTR and NOAC groups in AF patients.