Intermediate Risk Subjects Research Articles

Prognostic Impact and Clinical Implications of Adverse Tumor Grade in Very Favorable Low- and Intermediate-Risk Prostate Cancer Patients Treated with Robot-Assisted Radical Prostatectomy: Experience of a Single Tertiary Referral Center.

To assess the prognostic impact and predictors of adverse tumor grade in very favorable low- and intermediate-risk prostate cancer (PCa) patients treated with robot-assisted radical prostatectomy (RARP). Data of low- and intermediate PCa risk-class patients were retrieved from a prospectively maintained institutional database. Adverse tumor grade was defined as pathology ISUP grade group > 2. Disease progression was defined as a biochemical recurrence event and/or local recurrence and/or distant metastases. Associations were assessed by Cox's proportional hazards and logistic regression model. Between January 2013 and October 2020, the study evaluated a population of 289 patients, including 178 low-risk cases (61.1%) and 111 intermediate-risk subjects (38.4%); unfavorable tumor grade was detected in 82 cases (28.4%). PCa progression, which occurred in 29 patients (10%), was independently predicted by adverse tumor grade and biopsy ISUP grade group 2, with the former showing stronger associations (hazard ratio, HR = 4.478; 95% CI: 1.840-10.895; p = 0.001) than the latter (HR = 2.336; 95% CI: 1.057-5.164; p = 0.036). Older age and biopsy ISUP grade group 2 were independent clinical predictors of adverse tumor grade, associated with larger tumors that eventually presented non-organ-confined disease. In a very favorable PCa patient population, adverse tumor grade was an unfavorable prognostic factor for disease progression. Active surveillance in very favorable intermediate-risk patients is still a hazard, so molecular and genetic testing of biopsy specimens is needed.

Limited efficacy of 3 + 7 plus gemtuzumab ozogamycin in newly diagnosed fit intermediate genetic risk acute myeloid leukemia patients.

Gemtuzumab-ozogamycin (GO) is approved in combination with high-dose chemotherapy for treatment-naïve low- and intermediate-risk acute myeloid leukemia (AML). In this retrospective real-life multicenter study, we reported efficacy and safety of GO plus high-dose chemotherapy in newly diagnosed AML patients. A total of 31 fit low- and intermediate-risk AML patients treated with GO-based regimens were retrospectively included in this real-life multicenter study, and results were compared with a control cohort treated with 3 + 7 alone. Complete remission (CR) rate after induction was 77%, and most responders (45%) underwent two GO-based consolidation, and minimal residual disease (MRD) negativity was observed in 17 cases (55%) after the end of consolidation. Low genetic risk was associated with increased CR rate compared with intermediate-risk AML (88% vs. 33%; p < .001), as well as prolonged overall survival (OS; hazard ratio, 0.16; 95% confidential interval, 0.02-0.89; p < .001). GO addition resulted in a survival benefit for low-risk AML (median OS not reached vs. 25 months; p = .19) while not for intermediate-risk subjects (10 vs. 13 months; p = .92), compared with the control group. Moreover, GO-treated patients experienced fever of unknown origin or sepsis in 42% or 36% of cases, respectively, with one death during induction due to septic shock, with similar rates compared with the control group (p = .3480 and p = .5297, respectively). No cases of veno-occlusive disease after allogeneic transplantation were observed. Our real-life multicenter study confirmed GO-based treatment efficacy with high MRD negativity rates in fit newly diagnosed AML patients, especially in those with low genetic risk and core binding factor, while limited benefits were observed in intermediate-risk AML. However, further validation on larger prospective cohorts is required.

A Phase I Trial of Sirolimus with "7&3" Induction Chemotherapy in Patients with Newly Diagnosed Acute Myeloid Leukemia.

Chemotherapy remains a primary treatment for younger AML patients, though many relapse. Data from our group have shown that highly phosphorylated S6 in blasts may predict response to sirolimus given with chemotherapy. We report the results of a phase I study of this combination in newly diagnosed AML and the pharmacodynamic analysis of pS6 before and after treatment. Subjects received sirolimus (12 mg on day 1, 4 mg daily, days 2-10), then idarubicin and cytarabine (days 4-10). Response was assessed at hematologic recovery or by day 42 using a modified IWG criteria. Fifty-five patients received sirolimus. Toxicity was similar to published 7 + 3 data, and 53% had high-, 27% intermediate-, and 20% favorable-risk disease. Forty-four percent of the high-risk patients entered into CR/CRp. Seventy-nine percent of the intermediate-risk subjects had a CR/CRp. All favorable-risk patients had a CR by day 42; 9/11 remained alive and in remission with a median follow-up of 660 days. Additionally, 41/55 patients had adequate samples for pharmacodynamic analysis. All patients demonstrated activation of S6 prior to therapy, in contrast to 67% seen in previous studies of relapsed AML. mTORC1 inhibition was observed in 66% of patients without enrichment among patients who achieved remission. We conclude that sirolimus and 7 + 3 is a well-tolerated and safe regimen. mTORC1 appears to be activated in almost all patients at diagnosis of AML. Inhibition of mTORC1 did not differ based on response, suggesting that AML cells may have redundant signaling pathways that regulate chemosensitivity in the presence of mTORC1 inhibition.

The role of coronary computed tomography angiography in low- and intermediate-risk patients with chest pain: a paradigm shift in modern cardiology.

Chest pain is a common complaint among patients presenting to primary care physicians. The management of chest pain secondary to coronary artery disease is rapidly changing as new evidence increase our knowledge of this complex clinical problem. The 2021 multisociety guidelines developed by the American College of Cardiology and the American Heart Association along with other organizations and imaging societies represent the first international guidelines for the evaluation and diagnosis of patients with acute or stable chest pain. This review will discuss in details the evaluation of low- and intermediate risk subjects presenting with acute and stable chest pain both in the emergency and office settings, providing a practical approach, supported by contemporary evidence, for the management of this important clinical problem leveraging on the central role played by coronary computed tomography angiography as documented by current clinical guidelines and available scientific literature.

Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients

In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P < .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm2 vs 1.8 [0.6] cm2; P < .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P < .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.

Functional Status After Transcatheter and Surgical Aortic Valve Replacement: 2-YearAnalysisFrom the SURTAVI Trial.

This study sought to evaluate patient-centered metrics in intermediate-surgical-risk aortic stenosis patients enrolled in the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial treated with self-expanding transcatheter aortic valve replacement (TAVR) or surgery. Studies have shown TAVR to be an alternative to surgery in patients with severe symptomatic aortic stenosis but have focused on "hard endpoints," including all-cause mortality and stroke, rather than on comparative patient-centered metrics, such as functional status and symptom burden. The study analyzed functional status (6-minute walk test [6MWT]) and symptom burden (Kansas City Cardiomyopathy Questionnaire) in 1,492 patients from the SURTAVI trial at baseline, 30days, 1 year, and 2 years. Patients were categorized by baseline functional status into tertiles of slow, medium, and fast walkers. Patients with lowest capacity baseline functional status were commonly women, had higher Society of Thoracic Surgeons scores, and had more New York Heart Association functional class III or IV symptoms; reduced baseline functional status was associated with higher aortic valve- and heart failure-related hospitalization at 2 years. There was greater improvement in 6MWT distance in TAVR compared with surgery patients at 30days (P< 0.001) and 1 year (P=0.012), but at 2 years, both groups had similar improvement (P = 0.091). The percentage of patients with large improvement in 6MWT was greatest in patients categorized as slow walkers and lowest in fast walkers. Symptom burden improved after TAVR at 30days and after both procedures at 1 and 2 years. In this substudy of patients from the SURTAVI trial, patients receiving TAVR demonstrated a more rapid improvement in functional status and symptom burden compared with patients undergoing surgery; however, both groups had similar improvements in long-term follow-up. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910).

Prevalence and significance of risk enhancing biomarkers in the United States population at intermediate risk for atherosclerotic disease

Pooled cohort equations (PCEs) estimate 10-year risk for atherosclerotic cardiovascular disease (ASCVD) in US adults. One use is to guide statin eligibility. However, PCEs risk estimate is inaccurate in some US subpopulations. Recent cholesterol guidelines proposed addition of risk enhancing factors to improve risk assessment for selection of statin therapy. This study examines frequencies of several risk enhancing biomarkers in NHANES subjects at intermediate risk (7.5 -<20% 10-year risk for ASCVD) and considers how they may be used to better assess risk for individuals. Prevalence of the following biomarkers were determined; elevations in apolipoprotein B-containing lipoproteins, i.e., LDL cholesterol (LDL-C) (160-189 mg/dL), non-HDL-cholesterol (non-HDL-C) (190-219 mg/dL), or total apolipoprotein B (apoB) (≥ 130 mg/dL), serum triglyceride (≥175 mg/dL), hemoglobin A1c (5.7-6.4%), high sensitivity C-reactive protein (2-10 mg/L), and waist circumference ≥ 102 cm, and abnormal estimated glomerular filtration rate (15 - ≤ 60 mg/min/1.73 m2). 25% of NHANES population had intermediate risk. In this subpopulation, 85% had ≥ 1 biomarkers-similarly in women and men-with a third having ≥3 abnormal markers. Frequencies were not age-related, except in those 40-49 years, in whom > 40% had ≥3 abnormal biomarkers. It made little difference whether LDL-C, non-HDL-C or apoB was used as the atherogenic lipoprotein. Three or more enhancing risk factors in intermediate risk subjects can complement PCE-estimated 10-year risk and guide the patient-provider discussion toward use of lipid-lowering medication. Future research is needed to integrate risk estimates by PCE and multiple risk enhancers.

Utility of metabolic syndrome as a risk enhancing factor in decision of statin use

BackgroundStatins effectively reduce risk for atherosclerotic cardiovascular disease (ASCVD) when 10-year risk is ≥ 7.5%. In many patients at intermediate risk (7.5-<20% risk), there is uncertainty about reliability of risk assessment by current pooled cohort equations (PCE). A decision to initiate statin therapy is favored by several risk enhancing factors not employed in PCEs. ObjectiveThis study examines the scope of the metabolic syndrome, a risk enhancing factor, and its principal sequala, diabetes, in 26,796 US adults age 40–75 years from the NHANES survey data, 1999–2016. MethodsThe prevalence of metabolic syndrome without diabetes (MetS+) and of diabetes (DM+) were determined for 10-year risk categories estimated to be low (<7.5%), intermediate (7.5% -< 20%) and high (≥20%). Data were weighted to account for complex study design. Results90.4% of the population was free of ASCVD. In subjects projected to be at low risk by PCEs, MetS+ was present in 15.0% and 17.6% of women and men, respectively. MetS + increased to 30.6% of women and 29.6% of men at intermediate risk, and to 21.5% of women and 32.2% of men at high risk. In addition, DM+ was present in 6.1%/5.3% (F/M) of low risk individuals, 20.1%/14.8% (F/M) of intermediate risk subjects, and 44.3%/39.4% (F/M) of high-risk persons. Prevalence of both MetS+ and DM + rose progressively with age in women and men. ConclusionsMetS+ and DM + are common multiplex risk factors that predispose to higher lifetime risk and support statin therapy in patients at intermediate and high risk.

Impact of Repositioning on Outcomes Following Transcatheter Aortic Valve Replacement With a Self-Expandable Valve

ObjectivesThis study sought to compare outcomes following transcatheter aortic valve replacement when valve repositioning was performed (repositioned group) versus procedures without repositioning (nonrepositioned group). BackgroundThe Evolut R and Evolut PRO valves were designed to allow repositioning during deployment, yet the effect of repositioning on clinical outcomes remains unclear. MethodsPatients implanted with the Evolut R or PRO valve from the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial continued access study and the Evolut Low Risk Trial between June 2016 and November 2018 were combined. Baseline multidetector computed tomography data were analyzed for the Evolut Low Risk Trial patients. The primary outcomes were the rate of all-cause mortality and the rate of disabling stroke 30 days. Secondary outcomes were per Valve Academic Research Consortium-2. ResultsThe Evolut R or PRO valve was implanted in 946 patients, and repositioning was performed in 318 (33.6%). Compared with patients in the nonrepositioned group, patients in the repositioned group had lower Society of Thoracic Surgeons score (2.3 ± 1.3% vs. 2.6 ± 1.4%; p < 0.001) and fewer prior percutaneous coronary interventions (11.9% vs. 19.7%; p = 0.003). There were no differences in baseline multidetector computed tomography parameters between groups. There were no differences in the primary outcome of death (0.3% vs. 0.3%; p = 0.99) or disabling stroke (0.3% vs. 0.5%; p = 0.71) at 30 days or 1 year (1.9% vs. 2.9%; p = 0.44; and 0.8% vs. 0.9%%; p = 0.79, respectively). ConclusionsThe utilization of the repositioning feature of the Evolut valves was safe, and no differences in death or disabling stroke were observed at 30 days or 1 year between groups. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283; Safety and Efficacy Study of the Medtronic CoreValve® System In the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910)

Sonographic assessment of carotid atherosclerosis: preferred risk indicator for future cardiovascular events?

Carotid ultrasound allows rapid and reliable quantification of atherosclerosis in humans. Although the definition of carotid plaque is not uniform, intimal thickening of at least 1.5 mm is currently defined as plaque. Plaque can be easily quantified by tracing the plaque area, a software-independent low-cost technique. More sophisticated quantifications involve 3D volume acquisitions, which is software-dependent and not widely available. Carotid plaque has a higher prognostic impact than intimal thickening, and carotid plaque volume showed comparable prognostic power to coronary calcifications. According to the latest European Joint ESC guidelines, carotid artery scanning should be considered for adjusting the level of risk especially in intermediate-risk subjects. There are various methods to incorporate results from imaging into clinical decision making, such as using arterial age instead of chronological age in risk equations or post-test risk calculations using the sensitivity and the specificity of the results from a given carotid plaque burden. In subjects with low or intermediate cardiovascular risk, the search for atherosclerosis may be appropriate and ultrasound of the carotid or the femoral arteries could be the primary method applied (depending on local expertise). Assessment of carotid total plaque presence, progression, stability and regression over time may be a valuable clinical tool for optimising the intensity of preventive therapies.

Comparison of a Complete Percutaneous Versus Surgical Approach to Aortic Valve Replacement and Revascularization in Patients at Intermediate Surgical Risk: Results From the Randomized SURTAVI Trial.

For patients with severe aortic stenosis and coronary artery disease, the completely percutaneous approach to aortic valve replacement and revascularization has not been compared with the standard surgical approach. The prospective SURTAVI trial (Safety and Efficiency Study of the Medtronic CoreValve System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement) enrolled intermediate-risk patients with severe aortic stenosis from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score (Synergy Between PCI with Taxus and Cardiac Surgery Trial) >22 was an exclusion criterion. Patients were stratified according to the need for revascularization and then randomly assigned to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in the TAVR group underwent percutaneous coronary intervention, whereas those in the SAVR group had coronary artery bypass grafting. The primary end point was the rate of all-cause mortality or disabling stroke at 2 years. Of 1660 subjects with attempted aortic valve implants, 332 (20%) were assigned to revascularization. They had a higher Society of Thoracic Surgeons risk score for mortality (4.8±1.7% versus 4.4±1.5%; P<0.01) and were more likely to be male (65.1% versus 54.2%; P<0.01) than the 1328 patients not assigned to revascularization. After randomization to treatment, there were 169 patients undergoing TAVR and percutaneous coronary intervention, 163 patients undergoing SAVR and coronary artery bypass grafting, 695 patients undergoing TAVR, and 633 patients undergoing SAVR. No significant difference in the rate of the primary end point was found between TAVR and percutaneous coronary intervention and SAVR and coronary artery bypass grafting (16.0%; 95% CI, 11.1-22.9 versus 14.0%; 95% CI, 9.2-21.1; P=0.62), or between TAVR and SAVR (11.9%; 95% CI, 9.5-14.7 versus 12.3%; 95% CI, 9.8-15.4; P=0.76). For patients at intermediate surgical risk with severe aortic stenosis and noncomplex coronary artery disease (SYNTAX score ≤22), a complete percutaneous approach of TAVR and percutaneous coronary intervention is a reasonable alternative to SAVR and coronary artery bypass grafting. URL: https://www. gov. Unique identifier: NCT01586910.

Transcatheter versus surgical aortic valve replacement in low- and intermediate-risk patients: an updated systematic review and meta-analysis

Transcatheter aortic valve replacement (TAVR) has been recognized as a well-established alternative to surgical aortic valve replacement (SAVR) for symptomatic aortic stenosis with high surgical risk. With this updated systematic review and meta-analysis, we evaluated TAVR vs. SAVR in low- and intermediate-risk subjects. Studies comparing TAVR and SAVR in low-risk patients (defined as STS ≤ 8% or EuroSCORE ≤ 20%) were identified with electronic searches. The principal endpoint was all-cause mortality at short term (< 3months), 1, and 2years. Other outcomes of interest were cardiac mortality, neurological events, paravalvular leakage (PVL), myocardial infarction (MI), major bleeding, acute kidney injury (AKI), vascular complications, and new pacemaker (PM) implantation. Seventeen articles including 9805 (4956 TAVR and 4849 SAVR) patients were eligible. There was no significant difference in all-cause mortality at short term [odds ratio (OR) 0.83, 95% confidence interval (CI) 0.63-1.09], 1year (OR 1.01, 95% CI 0.86-1.20) and 2years (OR 0.86, 95% CI 0.64-1.16) between treatment groups. Subgroup analyses stratified by surgical risk score (low-risk subgroup: STS < 4% or EuroSCORE < 10%, intermediate-risk subgroup: the others) did not show interaction on primary endpoints. Compared to SAVR, TAVR had similar rates of neurological events, significantly lower risk of MI and AKI, but higher risk of vascular complications, new PM implantation and moderate/severe PVL. In low- and intermediate-risk patients, TAVR and SAVR have similar short- and mid-term all-cause mortality. Compared to SAVR, TAVR carries higher rates of vascular complications, PM implantation and moderate/severe PVL, but lower risk of MI and AKI.

Allogeneic Transplantation for Acute Myelogenous Leukemia in CR1

Allogeneic Transplantation for Acute Myelogenous Leukemia in CR1

Valvular Heart Disease in Women, Differential Remodeling, and Response to New Therapies.

In the United States, valvular heart disease (VHD) has a prevalence of 2.5%, most commonly presenting as aortic stenosis (AS) or mitral valve regurgitation (MR) and increasingly observed to be of a degenerative etiology. Women frequently have latent symptoms despite significant disease, and it is therefore pertinent to consider both clinical symptoms and imaging findings for decision-making on treatment. Indeed, significant advances have been made in noninvasive imaging allowing for more accurate diagnosis and disease prognostication. While echo remains the standard diagnostic test, multidetector computed tomography (MDCT) and magnetic resonance imaging (MRI) provide complementary information on aortic valve calcification and left ventricular (LV) function, respectively. For any given calcification load or increase in calcification density of the aortic valve, women have greater increase in aortic valve stenosis severity than men; thus, moderate AS in women warrants closer attention. MRI allows identification of different patterns of hypertrophy and remodeling, extent of LV fibrosis, and insights into differential reverse remodeling and clinical outcomes in men and women. In conjunction with surgical treatment, percutaneous technologies are being increasingly used in the management of VHD. Nearly 50% of patients undergoing transcatheter aortic valve replacement (TAVR) are women. In high- or intermediate-risk subjects with significant symptomatic AS, TAVR has been shown to be noninferior to surgical AVR (SAVR). Notably, whereas both treatment strategies are equally effective in men, transfemoral TAVR has been shown to be superior to SAVR resulting in better survival in women. Analogously, few data have examined sex differences with percutaneous MitraClip devices in the treatment of degenerative MR, and men and women appear to have equivalent composite outcomes. Randomized clinical trial data are presently awaited for outcomes in the percutaneous treatment of functional MR secondary to ischemic heart disease. This review discusses the current evidence in the diagnosis and treatment of VHD with a focus on sex differences in left-sided VHD and management in women.

Transcatheter aortic valve implantation in lower-risk patients: what is the perspective?

In the last decade, transcatheter aortic valve implantation (TAVI), a disruptive technology, has revolutionized the therapy of symptomatic severe aortic stenosis, and current guidelines state that the recommendations for TAVI and surgical aortic valve replacement (SAVR) are equivalent in patients at high-risk. Increased operator experience, technical advances in the new generation of transcatheter heart valves (THV) and excellent TAVI results in recently published randomized controlled trials have led to the expansion of TAVI indication as an alternative to SAVR in intermediate-risk subjects, given appropriate patient selection. The time is opportune to examine the role of TAVI in low-risk patients, currently the objective of on-going randomized trials. This review aims to summarize the available knowledge on TAVI in low- to intermediate-risk patients and to discuss the potential advantages and pitfalls TAVI will face in this clinical setting.

The year in cardiology 2016: peripheral circulation.

In an epidemiological update in 2016, cardiovascular (CV) disease has been estimated as cause of 45% of deaths in Europe, including 12% due to stroke and 14% to other CV diseases, highlighting the major burden of non-coronary artery diseases (i.e. aorta, carotid, and lower extremity arteries) and venous thromboembolism (VTE) in our continent ( Figure 1 ).1 Similar to previous years,2,3 relevant scientific evidence in these fields was brought out in 2016 which will affect our daily clinical practice. Figure 1 Proportion of all deaths due to major causes in Europe, latest available year (adapted from Townsend).1 In the new ‘2016 European guidelines on cardiovascular disease prevention in clinical practice’, the usefulness of carotid intima-media thickness to stratify CV risk has been strikingly challenged, and this marker is no longer recommended due to its high variability, low intra-individual reproducibility, and lack of added predictive value, even in intermediate risk subjects.4 In opposition, carotid plaque remains a valuable tool for CV risk stratification. In 2016, the long-term clinical equipoise of carotid artery stenting (CAS) vs. carotid endarterectomy (CEA) was confirmed by the 10 year analysis of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), reporting similar rates of death, stroke, or MI within 30 days, or ipsilateral stroke up to 10 years for both strategies (11.8% vs. 9.9%; P = 0.51) ( Table 1 ).5 View this table: Table 1 Summary of major randomized trials in the aorta, peripheral artery diseases, and venous thrombo-embolic disease in 2016 Peri-procedural stroke during CAS is often related to plaque embolization. The randomized Asymptomatic Carotid Trial (ACT) I compared CAS with embolic protection to CEA in 1453 patients with asymptomatic carotid stenosis, not considered at high surgical risk ( Table 1 ).6 The composite endpoint of death, stroke, or MI at 30 days, or ipsilateral stroke at 1 year, was non-inferior in CAS …

Transcatheter Aortic Valve Replacement in Low-Risk Patients Within the Observational Study of Effectiveness of SAVR–TAVI Procedures for Severe Aortic Stenosis Treatment Study

Transcatheter aortic valve replacement (TAVR) is a novel, disruptive technology that is revolutionizing the management of patients with aortic stenosis (AS). The landmark Placement of Aortic Transcatheter Valves (PARTNER) trial demonstrated that in patients with symptomatic severe AS who are not suitable for surgical aortic valve replacement (SAVR), TAVR significantly reduced the rates of death, with a number needed to treat only 5 patients to save 1 life at 5 years. In high-risk patients, the PARTNER trial demonstrated equivalent survival after TAVR using the Edwards Sapien balloon–expandable valve (Edwards Lifesciences, Corp, Irvine, CA) and SAVR although periprocedural risks differed with each procedure.1,2 Using the Medtronic self-expanding transcatheter heart valve (Medtronic, Inc, Minneapolis, MN), the CoreValve US Pivotal trial demonstrated the safety and efficacy of TAVR in extreme risk AS patients and superior survival with TAVR compared to SAVR in high-risk patients.3,4 These historic trials have generated unprecedented excitement and attention within the cardiology community. Cardiologists have eagerly pursued expanding indications, including, in large part, the expansion of this technology to healthier populations. Industry has also invested tremendously to rapidly address device pitfalls with novel transcatheter heart valve design iterations. Several valves are currently in development, and within a decade of the PARTNER trial, we are already commercially implanting third-generation devices. See Article by Rosato et al Soon after the completion of the aforementioned landmark trials, attention shifted to the use of TAVR in intermediate-risk patients. Multiple observational studies—primarily based on European centers—have attempted to elucidate comparative outcomes for TAVR and SAVR in intermediate-risk patients and have shown comparable short and midterm mortality between groups using propensity-score methodology.5–7 Piazza et al7 conducted an observational study derived from a large database (n=3666) of patients undergoing percutaneous and surgical AVR at 3 European …

OC-047 Adenoma Surveillance In The National Nhs Bowel Cancer Screening Programme – Is The High/intermediate Risk Stratification Appropriate?

IntroductionThe NHS Bowel Cancer Screening Programme (BCSP) guidelines advocate surveillance of high and intermediate risk subjects with adenomas, due to the risk of developing future advanced neoplastic lesions. This study...

OC-044 Predictors Of Advanced Neoplasia At Surveillance In Screening Population- A Study Of All High And Intermediate Risk Gorup Subjects In First Six Year Of Nhs Bcsp

IntroductionIn NHS BCSP, high and intermediate risk subjects with colorectal adenomas undergo surveillance colonoscopies. This guideline evidence was derived mostly from general population based studies. This study aims to evaluate...

Plasma lipidomic analysis predicts non-calcified coronary artery plaque in asymptomatic patients at intermediate risk of coronary artery disease

The optimal management of asymptomatic subjects at intermediate risk of coronary artery disease (CAD) is often uncertain. Re-stratification to a high- or low-risk category may enable optimization of preventative strategies. Coronary computed tomographic angiography (CCTA) enables a minimally invasive assessment of coronary artery plaque quantity and composition. Non-calcified plaque by CCTA is lipid-rich and more vulnerable to rupture and resultant acute coronary syndromes. The purpose of this study was to determine whether novel approaches to CAD risk stratification, such as plasma lipid profiling, may predict non-calcified plaque burden in intermediate risk subjects. CCTA and several markers of CAD (including plasma lipid profiling, carotid intima-media thickness, aortic pulse wave velocity, and high-sensitivity C-reactive protein) were prospectively performed in 100 asymptomatic patients at intermediate CAD risk according to the Framingham risk score. Segment stenosis scores (SSS) were calculated to evaluate the burden of total, calcified, and non-calcified coronary artery plaque. Non-calcified plaque was observed in 66 subjects and 158 (11%) of 1425 coronary artery segments. Eighteen lipid species demonstrated significant associations with non-calcified plaque burden, but not with total plaque or calcified plaque burden. No other marker of CAD was found to predict coronary artery plaque burden. Plasma lipidomic analysis can predict the burden of non-calcified coronary plaque in asymptomatic subjects at intermediate risk of CAD. Re-stratification of these patients by plasma lipid profiling may enable more appropriate and effective primary prevention management strategies.