Comparison of clinical outcomes in elderly patients undergoing TAVR- a nationwide analysis

Introduction Transcatheter aortic valve replacement (TAVR) is a less invasive alternative to traditional surgical aortic valve replacement (SAVR) that has been increasingly utilized in the management of aortic stenosis. Several studies have compared the outcomes of TAVR to SAVR, and studies have also compared the clinical outcomes in the elderly population. However, the comparison in outcomes of TAVR between patients more than 80 years and less than 80 years old has not been well characterized. Therefore, in this study, we sought to assess the hospital outcomes and major adverse events of TAVR in patients ≥80 years old compared to those <80 years. Methods We performed a retrospective observational study using the National Inpatient Sample for the year 2018. Using the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10) procedure codes we identified patients who underwent TAVR. We further divided these patients into two cohorts based on age being ≥80 years and <80 years old. The primary outcomes were the comparison of in-hospital mortality and major adverse events (MAE) in patients with TAVR procedure stratified based on age. Secondary analysis included sub-groups analysis of both the cohorts and comparing those with and without MAE as well as comparison of those with MAE only in both cohorts. Results We identified 63,630 patients who underwent TAVR procedures from January 1 to December 31, 2018. Among them, 35, 115(55%) were ≥80 years and 28,515(45%) were <80 years of age. There was no difference in the in-hospital mortality rate (1.6% vs. 1.1%, p=0.89) and rates of MAE (23.8 vs 23.4, p=0.49) between ≥80 and <80year patients. Anemia (aOR-2.12 vs. aOR-1.93), Liver disease (aOR-1.57 vs aOR-1.48), CKD (aOR-1.34 vs. aOR-1.68), history of stroke (aOR-1.54 vs. aOR-1.46), and a higher number of comorbidities were independently associated with higher odds of MAE in both groups. Among patients ≥80, increasing age was also associated with higher MAE (aOR-1.03). In patients who had MAE, those < 80 years had higher comorbidities compared to those ≥80 years (Charlson category ≥3 - 74.5 vs 67%, p<0.001). More patients of age ≥80 years old also belonged to zip-codes with higher median income (p<0.001). On multivariate analysis of patients with MAE on both cohorts, there was no significant difference in in-hospital mortality rate (p=0.65) and length of stay (p=0.12) but total hospital charges were higher for patients less than 80 years of age (283,618 vs 300,624$, p=0.04). However, patients ≥80 years had a higher rate of pacemaker insertion compared to those < 80 years (25.1 vs 24.4%, p=0.008). Conclusion This study shows that in patients undergoing TAVR, the in-hospital mortality and MAE were not statistically significant between those aged ≥80 years and < 80 years. However, among subjects who experienced MAE, those < 80 years had a higher proportion of comorbidities than those ≥80 years of age. Our study also shows that for those above 80 years of age undergoing TAVR, the odds of MAE increases by 3% for each year on increasing age.

Mortality and Major Adverse Events Improve With Increased Institutional Experience for Fenestrated and Branched Endovascular Aortic Repair

Objective: Our objective was to evaluate temporal trends in outcomes at our institution in the context a more heterogenous application of fenestrated/branched endovascular aneurysm repair (F/BEVAR). Methods: Patient and aneurysm characteristics, procedure details, and postoperative outcomes were collected for consecutive patients undergoing F/BEVAR between 2002 and February 2019 at our institution. Outcomes were compared between tertile 1 (T1, 2002–2010, n=47), T2 (2011–2014, n=47), and T3 (2015-February 2019, n=47). Results: We included 141 patients (74.8 ± 8.1 years, 83% male) with a mean follow-up of 28.0 ± 31.6 months. Proportion of patients with hypertension (63.8% T1, 85.1% T3, p=0.009), diabetes (6.4% T1, 29.7% T3, p=0.005), chronic obstructive pulmonary disease (COPD; 27.6% T1, 42.5% T3, p=0.07), and history of stroke (4.2% T1, 17% T3, p=0.07) increased over time. Aneurysm diameter (65.3±11.4mm) and extent (56.0% juxtarenal/pararenal, 22.0% type IV, 22.0% type I-III) did not differ between groups. Custom made devices were implanted in 96.5% of cases with 3.4 ± 0.7 vessels reimplanted/case. There was a trend toward increased history of aortic surgery (p=0.008) and less custom made devices (p=0.007) in T3. Total procedure time (383.5±119.2 minutes T1, 316.2±88.4 T3, p=0.02), contrast volume (222.8±109.1 mL T1, 139.2±62.7ml T3, p<0.0001), and estimated blood loss (601.3±458.1 mL T1, 413.3±317.7 mL T3, p=0.02) decreased over time. Overall 30-day mortality was 6.3%, 10.6%-T1, 6.3%-T2, and 2.1%-T3 (p=0.09). We noted significant improvement in survival over time; 1- and 3-year survival was 79% and 56%, 89% and 83%, and 90% and 90%, for T1, T2, and T3, respectively (p=0.007). In all, 467 of 480 target vessels were revascularized (97.3% success). Reintervention rate (30-day: 13.5%, follow-up: 34.7%) and reintervention free survival was not significantly different between groups. Any major adverse event (MAE) occurred in 36.9% of patients overall with a significant decrease from early (51.1%), mid (34.9%), to late in our experience (25.5%, p=0.03). In multivariate analyses, increasing institutional experience (T3), procedure time, age, and sex were independent predictors of major adverse events. Conclusion: We have shown improvement in F/BEVAR outcomes including mortality, MAEs, and procedural metrics with increasing institutional experience. We postulate that a combination of advancements in technique, surgical team and postoperative care experience, graft design and stent technologies, and patient selection contributed to improvement in outcomes.

Clinical evaluation of two adult oxygenator systems in terms of mortality and major adverse events

Purpose The primary aim of this study was to examine the effects of two oxygenator systems on major adverse events and mortality. Methods A total of 181 consecutive patients undergoing coronary artery bypass grafting in our clinic were retrospectively analyzed. The patients were divided into two groups according to the oxygenator used: Group M, in which a Medtronic Affinity (Medtronic Operational Headquarters, Minneapolis, MN, USA) oxygenator was used, and Group S, in which a Sorin Inspire (Sorin Group Italia, Mirandola, Italy) oxygenator was used. Results Group S consisted of 89 patients, whereas Group M included 92 patients. No statistically significant differences were found between the two groups in terms of age ( p = .112), weight ( p = .465), body surface area ( p = .956), or gender ( p = .484). There was no statistically significant difference in hemorrhage on the first or second postoperative day ( p = .318 and p = .455, respectively). No statistically significant differences were observed in terms of red blood cell ( p = .468), fresh frozen plasma ( p = .116), or platelet concentrate transfusion ( p = .212). Infections, wound complications, and delayed sternal closure were significantly more common in Group M ( p = .006, p = .023, and p = .019, respectively). Extracorporeal membrane oxygenators and intra-aortic balloon pumps were required significantly more frequently in Group S ( p = .025 and p = .013, respectively). Major adverse events occurred in 16 (18%) patients in Group S and 14 (15.2%) patients in Group M ( p = .382). Mortality was observed in six (6.7%) patients in Group S and three (3.3%) patients in Group M ( p = .232). No statistically significant difference was found between the two groups in terms of length of hospital stay ( p = .451). Conclusion The clinical outcomes of the two oxygenator systems, including mortality, major adverse events, hemorrhage, erythrocyte and platelet transfusions, and length of hospital stay, were similar.

The Impact of Drug Trials With Financial Conflict of Interests on the Meta-Analyses: A Meta-Epidemiological Study

Background: Drug trials with potential financial conflict of interests (FCOIs) may influence trial design, drug dosage, comparators, and promising results are more likely to be reported. The objective of this study was to assess the impact of trials with FCOIs on evidence synthesis in meta-analyses (MAs). Methods: A total of 96 MAs from the Cochrane Library about drug trials were investigated. The primary outcomes examined the proportion of conclusions that would change with the exclusion of trials with potential FCOIs. If the proportion of changed conclusions was below the non-inferiority margin of 10%, we considered that it was not inferior to include the trials with potential FCOIs in the MAs. Results: Only 54.17% of MAs reported the funding sources of each included trial, and in 21.88% of MAs, the author-industry-related financial ties of each included trial were reported. When trials with FCOIs were excluded, the changed conclusions of effectiveness and major adverse events were 13.16% and 11.11%, respectively, and the I 2 decreased by 13.56% and 10.09%, respectively. For serious adverse events, the exclusion of FCOIs trials did not lead to any change in conclusions; however, the I 2 decreased by 24.24%. The impact of trials without reported FCOIs was also examined on evidence synthesis, and the results showed that the changed conclusions of effectiveness and major adverse events were 5.26% and 6.25%, respectively, indicating non-inferiority. However, the I 2 increased by 13.60% and 12.37%, respectively. Conclusion: In this meta-epidemiological study, we demonstrated that trials with FCOIs may not only influence the final outcome of MAs but may also increase the heterogeneity of results. It is suggested that all MAs fully report the FCOIs involved in evidence-based research and explore the impact of its FCOIs to better provide a more valuable reference for patients, clinicians, and policymakers.

Frequency, Mortality, and Predictors of Adverse Outcomes for Endocarditis in Patients with Congenital Heart Disease: Results of a Nationwide Analysis Including 2512 Endocarditis Cases

Background: Infective endocarditis (IE) represents a major complication in patients with congenital heart disease (CHD) and is associated with high morbidity and mortality. The aim of this study was to analyse the frequency and outcome of IE in contemporary CHD patients based on all IE hospital admissions in Germany over a 10-year period. Methods: Based on data of all hospital admissions in Germany from 2009 to 2018, we identified all CHD cases with a diagnosis of IE. The data contained information on patient demographics, diagnoses, surgical procedures, and mortality. The primary endpoint of the study was endocarditis-associated mortality as well as major adverse events (defined as death or myocardial infarction, stroke, pulmonary embolism, sepsis, renal dialysis, resuscitation, or intubation). Results: Overall, 309,245 CHD inpatient cases were included in the analysis (underlying heart defects of simple complexity 55%, moderate complexity 23%, and complex heart defects 22%, respectively). Of those, 2512 (0.8% of all inpatient cases) were treated for IE. The mortality rate of IE inpatient cases was 6% with a major adverse events rate of 46%, and 41.5% of cases required surgical intervention. The overall IE associated mortality was lower in adult CHD cases compared to the 153,242 in adult IE cases without CHD (7.1% vs. 16.1%, p < 0.001). After adjustments using multivariable logistic regression analysis, the presence or complexity of CHD was not associated with the outcomes. Meanwhile, age, male sex, and co-morbidities emerged as significant predictors of adverse outcomes. Conclusions: IE accounts for a minority of CHD related hospitalizations but remains a deadly disease, and major adverse events are common in this setting. Due to different demographic and co-morbidity spectrums, adult CHD patients tend to have better survival prospects when compared to non-CHD IE patients. Acquired co-morbidities emerged as the main predictors of adverse outcomes.

Combined Anticoagulation and Antiaggregation in Acute Cervical Artery Dissection

Cervical artery dissection (CAD) is a frequent cause of stroke in young adults. Previous studies investigating the efficiency of anticoagulation (AC) versus antiplatelet therapy (AT) found an insignificant difference. We therefore retrospectively evaluated a combination of AC plus AT in patients with acute CAD regarding safety and efficacy. Twenty-eight patients with CAD and minor neurological symptoms/no major infarction received either single (n = 14) or dual AT (n = 14) combined with AC. Angiographic follow-up during hospitalization, 4-8 weeks and 3–6 months after CAD focused on occlusion, residual stenosis, and functional recanalization. Possible adverse events were surveyed. We compared the AC plus AT group to 22 patients with acute CAD treated with AC or AT. Compared to preceding AC-/AT-only studies, AC plus single or dual AT resulted in more frequent, faster recanalization. Frequency and severity of adverse events was comparable. No major adverse events or death occurred. Preceding works on conservative treatment of CAD are discussed and compared to this study. Considerations are given to pathophysiology and the dynamic of CAD. Combining AC plus AT in CAD may result in more reliable recanalization in a shorter time. The risk for adverse events appears similar to treatment with only AC or AT.