Trans oral robotic surgery for oropharyngeal cancer: A multi institutional experience.

OBJECTIVES: Trans Oral Robotic Surgery (TORS) has proved to be a safe and feasible treatment for oropharyngeal squamous cell carcinoma (OPSCC). The aim of this study is to analyse oncological outcomes of OPSCC patients treated with TORS. MATERIALS AND METHODS: This study involved 139 patients with OPSCC, treated with TORS between 2008 and 2020. Clinicopathological characteristics, treatment details and oncological outcomes were evaluated retrospectively. RESULTS: The management strategies included TORS alone in 42.5%, TORS-RT in 25.2% and TORS-CRT in 30.9%. The ENE was noted in 28.8% of neck dissections. In 19 patients clinically classified as unknown primaries, the primary was found in 73.7%. Rates of local, regional relapses and distant metastasis were 8.6%, 7.2%, and 6.5%, respectively. The 5 year- Overall Survival and Disease Free Survival were 69.6% and 71.3%, respectively. CONCLUSION: TORS fits well in the modern management of OPSCC. Although definitive CRT remains a milestone, TORS is proving to be a valid and safe treatment option. The choice of the therapeutic strategy requires evaluation by a multidisciplinary team.

Subcutaneous emphysema as a complication of otorhinolaryngological surgical procedures.

INTRODUCTION: Subcutaneous emphysema (SE) represents, after bleeding and infections, a common complication in ENT surgery, given the intimate relationship between upper airways and anatomical area pertaining head and neck surgeon. Aim of this review is to analyze its characteristics, method of diagnosis and treatment to provide the specialist a useful tool for its early recognition. EVIDENCE ACQUISITION: A narrative review was carried out in accordance with the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement. A total of 164 articles were collected and most of them were case reports. EVIDENCE SYNTHESIS: Of 273 articles taken into consideration, only 164 met inclusion criteria. Review of all cases of SE in relation to surgical ENT procedures allow to classify each etiology on the surgical procedure that could be complicated with SE: laryngo-tracheal procedures, thyroid surgery, nasal and otological surgery, adenotonsillectomies. Moreover, traumatic orotracheal intubation, as well as alveolar rupture because of positive pressure ventilation or rupture of a preexisting abnormality, must be always taken into account. CONCLUSIONS: All ENT surgery can be complicated by SE. Diagnosis is simple and usually based only on physical examination, but correct and quick diagnosis is required. Treatment is in most of the time exclusively conservative, but SE could also represent a surgical emergency, given the possible evolution in pneumothorax/pneumomediastinum with serious consequences for patient's health.

The Effects of Barbed Repositioning Pharyngoplasty in Positional and Non-Positional OSA Patients: A Retrospective Analysis.

PURPOSE: The aim of our retrospective study is evaluating the effectiveness of barbed repositioning pharyngoplasty (BRP) in a consecutive cohort of patients and assessing its impact on positional indexes in order to potentially identify specific obstructive sleep apnea (OSA) phenotypes for patients who might benefit more significantly from this intervention. METHODS: A single-center retrospective study with baseline and follow-up type III sleep tests evaluating the Apnea Hypopnea Index (AHI), supine AHI, non-supine AHI, oxygen desaturation index (ODI), mean SaO2, percentage of time spent at SaO2 below 90% (CT90), and lowest oxygen saturation (LOS) were performed. The patients were then divided into groups according to Sher's criteria and Amsterdam Positional OSA Classification (APOC). Parametric and non-parametric tests and univariate and multivariate analyses were conducted. RESULTS: The study finally included 47 patients. The statistical analysis showed significant improvement in AHI, supine AHI, non-supine AHI, and ODI after surgery. The linear regression showed that high values of baseline AHI, AHI supine, and AHI non supine predict more significant postoperative reductions in AHI, AHI supine, and AHI non supine, respectively. Therapeutic success was achieved in 22 patients out of 47. The logistic regression did not find any independent risk factors for success. The most significant reduction in AHI, supine AHI, and non-supine AHI was observed in the APOC 3 group while the APOC 1 patients experience a substantially lower improvement. CONCLUSIONS: BRP appears to be an effective surgical procedure for the treatment of OSA. The non-positional patients might benefit more from BRP in comparison with positional patients. Moreover, OSA severity should not be considered an absolute contra-indication for this surgical procedure.

The impact of optimal medical therapy on patients with recurrent acute myocardial infarction: Subanalysis from the BleeMACS study.

BACKGROUND: Acute myocardial infarction (AMI) recurrence is still high despite great progress in secondary prevention. Patients with recurrent AMI suffer worse prognosis compared to those with first AMI. The objective was to evaluate the effect of optimal medical therapy (OMT) on these patients with recurrent AMI. METHODS AND RESULTS: Sub-analysis was performed including 13,343 patients with AMI from the international multicenter Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome (BleeMACS) registry. OMT was defined as the combination of aspirin, any P2Y12 inhibitor, statin, angiotensin converting enzyme inhibitor/angiotensin receptor blocker, and beta-blocker. Among 1285 patients with prior AMI, 56.8% received OMT prescription. Patients receiving OMT suffered from less congestive heart failure, peripheral artery disease, malignancy, and bleeding history. Kaplan-Meier survival estimates revealed that OMT was strongly related to decreased in all-cause death (4.2% vs. 10.1%, p < .001) and the composite endpoint of death/re-AMI (11.1% vs. 16.9%, p = .005) at 1-year follow-up. OMT was the independent protect factor of primary endpoint even after adjusting for multiple possible confounders (HR, 0.46; 95% CI, 0.27-0.78; p = .004). However, no significant difference was observed regarding re-AMI between OMT and non-OMT groups. OMT also reduced all-cause death in patients with recurrent AMI after propensity score matching. CONCLUSIONS: The prescription of OMT was seriously insufficient in patients with recurrent AMI, especially high-risk patients, even though OMT was associated with improved prognosis. Further improvements in pharmacological therapy are needed to reduce subsequent recurrent events.

Psychological distress in patients under surveillance for intraductal papillary mucinous neoplasms of the pancreas: The "Sword of Damocles" effect calls for an integrated medical and psychological approach a prospective analysis.

INTRODUCTION: Most intraductal papillary mucinous neoplasms (IPMNs) of the pancreas can be safely surveilled. Their psychological impact is not known. The aim of this study is to obtain a psychological profile of patients under surveillance and compare the results to patients undergoing surgery. METHODS: Patients under surveillance for IPMNs evaluated between 2017 and 2019 at the pancreatic cysts clinic of The Pancreas Institute of Verona were compared to patients undergoing surgery for the same disease. Patients with high-risk stigmata were excluded in both groups. Patients were profiled with the Barratt Simplified Measure of Socio-Economic Status (BSMSS), the Brief Coping Orientation to Problems Experienced (Brief-COPE), the Perceived Stress Scale (PSS), the Symptom Checklist-90 and the Short Form Health Survey (SF-36). Age, sex, BSMSS and Brief-COPE were used to match patients with the propensity score as potential sources of bias. RESULTS: Two hundred patients were profiled. After the matching, 74 patients under surveillance were compared to 74 patients who underwent surgery. Patients under surveillance reported significantly increased scores for symptoms such as somatization (0.71 vs. 0.54, p = 0.032), depression (0.45 vs 0.31, p = 0.047) and anxiety (0.45 vs. 0.27, p = 0.002). They also reported a reduced health perception in the domain of physical role functioning (54 vs. 68, p = 0.046). CONCLUSION: Patients under surveillance for a presumed IPMN experience anxiety and stress and feel less healthy than do patients undergoing surgery. This reduction in quality of life should always be taken into account and warrants an integrated medical-psychological approach in selected cases.

Incidence, predictors and cerebrovascular consequences of leaflet thrombosis after transcatheter aortic valve implantation: a systematic review and meta-analysis.

OBJECTIVES: We examined the incidence, the impact of subsequent cerebrovascular events and the clinical or procedural predictors of leaflet thrombosis (LT) in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: MEDLINE/PubMed was systematically screened for studies reporting on LT in TAVI patients. Incidence [both clinical and subclinical, i.e. detected with computed tomography (CT)] of LT was the primary end point of the study. Predictors of LT evaluated at multivariable analysis and impact of LT on stroke were the secondary ones. RESULTS: Eighteen studies encompassing 11 124 patients evaluating incidence of LT were included. Pooled incidence of LT was 0.43% per month [5.16% per year, 95% confidence interval (CI) 0.21-0.72, I2 = 98%]. Pooled incidence of subclinical LT was 1.36% per month (16.32% per year, 95% CI 0.71-2.19, I2 = 94%). Clinical LT was less frequent (0.04% per month, 0.48% per year, 95% CI 0.00-0.19, I2 = 93%). LT increased the risk of stroke [odds ratio (OR) 4.21, 95% CI 1.27-13.98], and was more frequent in patients with a valve diameter of 28-mm (OR 2.89: 1.55-5.8), for balloon-expandable (OR 8: 2.1-9.7) or after valve-in-valve procedures (OR 17.1: 3.1-84.9). Oral anticoagulation therapy reduced the risk of LT (OR 0.43, 95% CI: 0.22-0.84, I2 = 64%), as well as the mean transvalvular gradient. CONCLUSIONS: LT represents an infrequent event after TAVI, despite increasing risk of stroke. Given its full reversal with warfarin, in high-risk patients (those with valve-in-valve procedures, balloon expandable or large-sized devices), a protocol which includes a control CT appears reasonable.

Percutaneous coronary intervention or coronary artery bypass graft in left main coronary artery disease: a comprehensive meta-analysis of adjusted observational studies and randomized controlled trials.

BACKGROUND: Treatment of patients with ULMCA (unprotected left main coronary artery disease) with percutaneous coronary intervention (PCI) has been compared with coronary artery bypass graft (CABG), without conclusive results. METHODS: All randomized controlled trials (RCTs) and observational studies with multivariate analysis comparing PCI and CABG for ULMCA were included. Major cardiovascular events (MACEs, composite of all-cause death, MI, definite or probable ST, target vessel revascularization and stroke) were the primary end points, whereas its single components were the secondary ones, along with stent thrombosis, graft occlusion and in-hospital death and stroke. Subgroup analyses were performed according to Syntax score. RESULTS: Six RCTs (4717 patients) and 20 observational studies with multivariate adjustment (14 597 patients) were included. After 5 (3-5.5) years, MACE rate was higher for PCI [odds ratio (OR) 1.10, 95% confidence interval (CI) 1.07-1.14], without difference in death, whereas more relevant risk of MI was because of observational studies. Coronary stenting increased risk of revascularization (OR 1.52; 95% CI 1.34-1.72). At meta-regression, performance of PCI was improved by use of intra-coronary imaging and worsened by first generation stents, whereas two arterial grafts increased benefit of CABG. For patients with Syntax score less than 22, MACE rates did not differ, whereas for higher values, CABG reduced MACE because of lower risk of revascularization. Incidence of graft occlusion was 3.24% (2.25-4.23), whereas 2.13% (1.28-2.98: all CI 95%) of patients experienced stent thrombosis. CONCLUSION: Surgical revascularization reduces risk of revascularization for ULMCA patients, especially for those with Syntax score greater than 22, with a higher risk of in-hospital death. Intra-coronary imaging and use of arterial grafts improved performance of revascularization strategies.

Intracoronary versus intravenous adenosine to assess fractional flow reserve: a systematic review and meta-analysis.

AIMS: Intravenous infusion of adenosine is the reference method to measure fractional flow reserve (FFR). Intracoronary boluses are often used because of time and convenience, but their effectiveness has yet to be assessed. METHODS: We conducted a systematic review and meta-analysis of prospective studies directly comparing intravenous and intracoronary adenosine administration for FFR measurement. FFR values and prevalence of functionally critical lesions obtained with the different methods of adenosine administration were compared. RESULTS: Twelve studies evaluating 781 lesions from 731 patients were included (63.7 years, 25.5% women, median FFR 0.82). FFR values were significantly lower with intravenous adenosine than with intracoronary adenosine [mean difference 0.01, 95% confidence interval (CI) 0.00-0.02, P = 0.005], even if no significant differences were observed when only high doses of intracoronary adenosine (≥150 µg) were considered. The prevalence of functionally critical lesions did not significantly differ between intracoronary and intravenous adenosine. Concerning the use of different doses of intracoronary adenosine, low doses (≤60 µg) were associated with higher FFR values (mean difference 0.02, 95% CI 0.01-0.03, P < 0.001) and fewer functionally critical lesions (OR 0.57, 95% CI 0.40-0.81, P = 0.002) compared with high doses. Meta-regression analysis did not show any significant interaction between the way of adenosine administration and main clinical features. Intracoronary adenosine was associated with a higher incidence of atrioventricular blocks, whereas angina and/or systemic symptoms were more frequent with intravenous adenosine. CONCLUSION: Intracoronary adenosine might be as effective as intravenous adenosine to measure FFR, provided that adequate doses are used. Intracoronary adenosine represents a valuable alternative to intravenous adenosine whenever appropriately administered.

The EUROpean and Chinese cardiac and renal Remote Ischemic Preconditioning Study (EURO-CRIPS CardioGroup I): A randomized controlled trial.

BACKGROUND: The potential protective effects of remote ischemic preconditioning (RIPC) on contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI) remain to be defined. METHODS AND RESULTS: A double blind, randomized, placebo controlled multicenter study was performed. Patients younger than 85years old, with a renal clearance of 30-60ml/min/1.73m2, who were candidates for PCI for all clinical indications except for primary PCI, were allocated 1:1 to RIPC or to standard therapy. The primary endpoint was incidence of CIN. The secondary endpoint was incidence of peri-procedural myocardial infarction (PMI). From February 2013 to April 2014, 3108 patients who were scheduled for coronary angiography were screened for the study. 442 fulfilled the inclusion criteria and 223 received PCI. These patients were randomized to sham RIPC (n=107) or treatment group (n=116). The only pre-specified subgroup of diabetic patients included 85 (38%) cases. RIPC significantly reduced CIN incidence in the overall population (12.1% vs. 26.1%, p=0.01, with a NNT=9) and in non-diabetic patients (9.2% vs. 25.0%, p=0.02), but showed no benefit in diabetics (16.7% vs. 28.2%, p=0.21). A trend for lower PMI was seen in the intervention arm (creatine kinase - muscle brain >5 URL; 8.4% vs. 16.4%, p=0.07; troponin T >5 URL; 27% vs. 38%, p=0.21). CONCLUSIONS: Remote ischemic preconditioning significantly reduces the incidence of acute kidney injury in non-diabetic patients undergoing PCI. Larger sample size is presumably needed to assess the effect of RIPC for patients with diabetes mellitus. Clinical Trial number:NCT02195726https://www.clinicaltrial.gov/.

Development and external validation of a post-discharge bleeding risk score in patients with acute coronary syndrome: The BleeMACS score.

BACKGROUND: Accurate 1-year bleeding risk estimation after hospital discharge for acute coronary syndrome (ACS) may help clinicians guide the type and duration of antithrombotic therapy. Currently there are no predictive models for this purpose. The aim of this study was to derive and validate a simple clinical tool for bedside risk estimation of 1-year post-discharge serious bleeding in ACS patients. METHODS: The risk score was derived and internally validated in the BleeMACS (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome) registry, an observational international registry involving 15,401 patients surviving admission for ACS and undergoing percutaneous coronary intervention (PCI) from 2003 to 2014, engaging 15 hospitals from 10 countries located in America, Europe and Asia. External validation was conducted in the SWEDEHEART population, with 96,239 ACS patients underwent PCI and 93,150 without PCI. RESULTS: Seven independent predictors of bleeding were identified and included in the BleeMACS score: age, hypertension, vascular disease, history of bleeding, malignancy, creatinine and hemoglobin. The BleeMACS risk score exhibited a C-statistic value of 0.71 (95% CI 0.68-0.74) in the derivation cohort and 0.72 (95% CI 0.67-0.76) in the internal validation sample. In the SWEDEHEART external validation cohort, the C-statistic was 0.65 (95% CI 0.64-0.66) for PCI patients and 0.63 (95% CI 0.62-0.64) for non-PCI patients. The calibration was excellent in the derivation and validation cohorts. CONCLUSIONS: The BleeMACS bleeding risk score is a simple tool useful for identifying those ACS patients at higher risk of serious 1-year post-discharge bleeding. ClinicalTrials.govIdentifier: NCT02466854.

Prevalence and outcome of patients with cancer and acute coronary syndrome undergoing percutaneous coronary intervention: a BleeMACS substudy.

BACKGROUND: The prevalence and outcome of patients with cancer that experience acute coronary syndrome (ACS) have to be determined. METHODS AND RESULTS: The BleeMACS project is a multicentre observational registry enrolling patients with acute coronary syndrome undergoing percutaneous coronary intervention worldwide in 15 hospitals. The primary endpoint was a composite event of death and re-infarction after one year of follow-up. Bleedings were the secondary endpoint. 15,401 patients were enrolled, 926 (6.4%) in the cancer group and 14,475 (93.6%) in the group of patients without cancer. Patients with cancer were older (70.8±10.3 vs. 62.8±12.1 years, P<0.001) with more severe comorbidities and presented more frequently with non-ST-segment elevation myocardial infarction compared with patients without cancer. After one year, patients with cancer more often experienced the composite endpoint (15.2% vs. 5.3%, P<0.001) and bleedings (6.5% vs. 3%, P<0.001). At multiple regression analysis the presence of cancer was the strongest independent predictor for the primary endpoint (hazard ratio (HR) 2.1, 1.8-2.5, P<0.001) and bleedings (HR 1.5, 1.1-2.1, P=0.015). Despite patients with cancer generally being undertreated, beta-blockers (relative risk (RR) 0.6, 0.4-0.9, P=0.05), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (RR 0.5, 0.3-0.8, P=0.02), statins (RR 0.3, 0.2-0.5, P<0.001) and dual antiplatelet therapy (RR 0.5, 0.3-0.9, P=0.05) were shown to be protective factors, while proton pump inhibitors (RR 1, 0.6-1.5, P=0.9) were neutral. CONCLUSION: Cancer has a non-negligible prevalence in patients with acute coronary syndrome undergoing percutaneous coronary intervention, with a major risk of cardiovascular events and bleedings. Moreover, these patients are often undertreated from clinical despite medical therapy seems to be protective. Registration:The BleeMACS project (NCT02466854).

Cardiovascular events and target organ damage in primary aldosteronism compared with essential hypertension: a systematic review and meta-analysis.

BACKGROUND: There is conflicting evidence, relying on heterogeneous studies, as to whether aldosterone excess is responsible for an increased risk of cardiovascular and cerebrovascular complications in patients with primary aldosteronism. We aimed to assess the association between primary aldosteronism and adverse cardiac and cerebrovascular events, target organ damage, diabetes, and metabolic syndrome, compared with the association of essential hypertension and these cardiovascular and end organ events, by integrating results of previous studies. METHODS: We did a meta-analysis of prospective and retrospective observational studies that compared patients with primary aldosteronism and essential hypertension, to analyse the association between primary aldosteronism and stroke, coronary artery disease (as co-primary endpoints), atrial fibrillation and heart failure, target organ damage, metabolic syndrome, and diabetes (as secondary endpoints). We searched MEDLINE and Cochrane Library for articles published up to Feb 28, 2017, with no start date restriction. Eligible studies compared patients with primary aldosteronism with patients with essential hypertension (as a control group) and reported on the clinical events or endpoints of interest. We also compared primary aldosteronism subtypes, aldosterone-producing adenoma, and bilateral adrenal hyperplasia. FINDINGS: We identified 31 studies including 3838 patients with primary aldosteronism and 9284 patients with essential hypertension. After a median of 8·8 years (IQR 6·2-10·7) from the diagnosis of hypertension, compared with patients with essential hypertension, patients with primary aldosteronism had an increased risk of stroke (odds ratio [OR] 2·58, 95% CI 1·93-3·45), coronary artery disease (1·77, 1·10-2·83), atrial fibrillation (3·52, 2·06-5·99), and heart failure (2·05, 1·11-3·78). These results were consistent for patients with aldosterone-producing adenoma and bilateral adrenal hyperplasia, with no difference between these subgroups. Similarly, primary aldosteronism increased the risk of diabetes (OR 1·33, 95% CI 1·01-1·74), metabolic syndrome (1·53, 1·22-1·91), and left ventricular hypertrophy (2·29, 1·65-3·17). INTERPRETATION: Diagnosing primary aldosteronism in the early stages of disease, with early initiation of specific treatment, is important because affected patients display an increased cardiovascular risk compared with patients with essential hypertension. FUNDING: None.

Prospective assessment of a palliative care tool to predict one-year mortality in patients with acute coronary syndrome.

BACKGROUND: Identifying patients with acute coronary syndrome (ACS) who are approaching the end of life and who may not benefit from an aggressive interventional approach is important but clinically challenging. The Gold Standards Framework (GSF) prognostic guide was developed using multidimensional criteria to identify cancer patients who could benefit from end-of-life care. We assessed the utility of the GSF to predict one-year mortality in ACS patients. METHODS: ACS patients admitted between May 2012 and July 2013 at the three participating cardiac centres in Europe were enrolled. Patients were assessed during admission using the GSF, the Global Registry of Acute Coronary Events (GRACE) score, the age, creatinine, ejection fraction (ACEF) score and the New York Percutaneous Coronary Intervention (NY-PCI) risk score. The pre-specified primary outcome was all-cause mortality at one year; secondary outcomes were cardiovascular death, non-cardiovascular mortality, re-hospitalisation for ACS and re-hospitalisation for non-ACS causes. RESULTS: Six hundred and twenty-nine ACS patients were enrolled and one-year follow-up data was available for 626 patients. Fifty-two patients (8.3%) met GSF criteria for end-of-life care. These patients were older, predominantly female, had lower body mass index (BMI), and were less likely to receive angiography (75% vs 95%, p<0.001) and angioplasty (60% vs 77%, p=0.005) compared with patients who did not meet GSF criteria. Patients meeting GSF criteria had higher one-year all-cause mortality (42.3% vs 4.5%, p<0.001), cardiovascular mortality (15.4% vs 2.8%, p<0.001) and non-cardiovascular mortality (26.9% vs 1.7%; p<0.001). Multivariate analysis confirmed that meeting GSF criteria independently predicted all-cause mortality. CONCLUSION: GSF is a multidimensional tool which may be used to identify ACS patients that are at high risk of death and may benefit from end-of-life care.

Optimal Medical Therapy in Patients with Malignancy Undergoing Percutaneous Coronary Intervention for Acute Coronary Syndrome: a BleeMACS Sub-Study.

OBJECTIVE: Our objective was to define the most appropriate treatment for acute coronary syndrome (ACS) in patients with malignancy. METHODS AND RESULTS: The BleeMACS project is a worldwide multicenter observational prospective registry in 16 hospitals enrolling patients with ACS undergoing percutaneous coronary intervention. Primary endpoints were death, re-infarction, and major adverse cardiac events (MACE; composite of death and re-infarction) after 1 year of follow-up. The secondary endpoint was bleeding events during follow-up. We performed sub-study analyses according to whether ß-blockers (BBs), angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), statins, or proton pump inhibitors (PPIs) were prescribed at discharge. We also calculated the propensity score for optimal medical therapy (OMT; combination of BB, ACEI/ARB, and statins). The study included 926 patients. According to the multivariate analysis, ACEIs/ARBs (hazard ratio [HR] 0.58, 95 % confidence interval [CI] 0.36-1.94; p = 0.03) and statins (HR 0.37, 95 % CI 0.23-0.61; p < 0.01) reduced the risk of MACE, while the effects of BBs (HR 0.85, 95 % CI 0.55-1.32; p = 0.48) and PPIs (HR 1.33, 95 % CI 0.83-2.12; p = 0.23) were not significant. OMT was prescribed at discharge in 300 (32.4 %) patients; after propensity score analysis, OMT showed a significant reduction in death (3 % vs. 12.5 %, HR 0.21, 95 % CI 0.1-0.4; log-rank p < 0.001) and MACE (6.7 vs. 15.2 %, log-rank p = 0.01). CONCLUSION: In patients with ACS and malignancy, OMT reduces the risk of adverse events at 1 year; in particular, ACEIs/ARBs and statins were the most protective drugs. (Clinical trials identifier: NCT02466854).

[Impact of concomitant use of P2Y12 inhibitors and proton pump inhibitors on ischemia events in patients with acute coronary syndrome in real world].

Objective: The study aimed to analyze the impact of concomitant administration of P2Y12 inhibitors and PPIs on ischemia events in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI). Methods: We retrospectively analyzed data from a international, multi-center registry between 2003 and 2014 in patients with ACS after PCI, grouped the cohort into patients receiving PPIs or no PPIs and assessed 1-year clinical endpoint (all-cause death/re-infarction). Meanwhile, we grouped the cohort into patients receiving clopidogrel or ticagrelor, and compared the impact of concomitant administration of PPIs and clopidogrel or ticagrelor on 1-year clinical endpoint. Results: Of 9 429 patients in the final cohort, 54.8% (n=5 165) was prescribed a PPI at discharge. Patients receiving a PPI were more likely to have comorbidities. No association was observed between PPI use and the clinical endpoint (HR 1.00, 95% CI 0.86-1.18). Meanwhile, no association was found between PPI use and the clinical endpoint in patients receiving either clopidogrel or ticagrelor. And the clinical endpoint in patients administrated of clopidogrel and PPIs had no difference with that of ticagrelor and PPIs. Conclusions: In patients with ACS following PCI, increased risk of ischemia event was not found in the concomitant use of PPIs and P2Y12 inhibitors, and especially, compared with ticagrelor, clopidogrel was found no association with ischemia events when concomitant administrated with PPIs.

Early and mid-term outcomes of 1904 patients undergoing transcatheter balloon-expandable valve implantation in Italy: results from the Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER).

OBJECTIVES: The aim of this multicentre study is to report the clinical experiences of all patients undergoing transcatheter aortic valve implantation (TAVI) with a balloon-expandable device in Italy. METHODS: The Italian Transcatheter balloon-Expandable valve Registry (ITER) is a real-world registry that includes patients who have undergone TAVI with the Sapien (Edwards Lifesciences, Irvine, CA, USA) bioprosthesis in Italy since it became available in clinical practice. From 2007 to 2012, 1904 patients were enrolled to undergo TAVI in 33 Italian centres. Outcomes were classified according to the updated Valve Academic Research Consortium (VARC-2) definitions. A multivariable analysis was performed to identify independent predictors of all-cause mortality. RESULTS: Mean age was 81.7 (SD:6.2) years, and 1147 (60.2%) patients were female. Mean Logistic EuroSCORE was 21.1% (SD:13.7). Transfemoral, transapical, transaortic and transaxillary TAVI was performed in 1252 (65.8%), 630 (33.1%), 18 (0.9%) and 4 (0.2%) patients, respectively. Operative mortality was 7.2% (137 patients). The VARC-2 outcomes were as follows: device success, 88.1%; disabling stroke, 1.0%; life-threatening and major bleeding 9.8 and 10.5%, respectively; major vascular complication, 9.7%; acute kidney injury, 8.2%; acute myocardial infarction ≤72 h, 1.5%. Perioperative pacemaker implantation was necessary in 116 (6.1%) patients. At discharge, the mean transprosthetic gradient was 10.7 (SD:4.5) mmHg. Incidence of postoperative mild, moderate or severe paravalvular leak was, respectively, 32.1, 5.0 and 0.4%. A total of 444/1767 (25.1%) deaths after hospital discharge were reported: of these, 168 (37.8%) were classified as cardiac death. Preoperative independent predictors of all-cause mortality were male gender (HR: 1.395; 95% CI:1.052-1.849); overweight, BMI 25-30 kg/m2 (HR: 0.775; 95% CI: 0.616-0.974); serum creatinine level (every 1 mg/dl increase; HR: 1.314; 95% CI:1.167-1.480); haemoglobin level (every 1 g/dl increase; HR: 0.905; 95% CI:0.833-0.984); critical preoperative state (HR: 2.282; 95% CI: 1.384-3.761); neurological dysfunction (HR: 1.552; 95% CI:1.060-2.272); atrial fibrillation (HR: 1.556; 95% CI:1.213-1.995); pacemaker rhythm (HR: 1.948; 95% CI:1.310-2.896); NYHA Class III or IV (HR: 1.800; 95% CI:1.205-2.689 or HR: 2.331; 95% CI:1.392-3.903, respectively). CONCLUSIONS: TAVI with a balloon-expandable device in the 'real world' shows good mid-term outcomes in terms of survival, technical success, valve-related adverse events and haemodynamic performance.

64 slice-coronary computed tomography sensitivity and specificity in the evaluation of coronary artery bypass graft stenosis: A meta-analysis.

A non-invasive approach to define grafts patency and stenosis in the follow-up of coronary artery bypass graft (CABG) patients may be an interesting alternative to coronary angiography. 64-slice-coronary computed tomography is nowadays a diffused non-invasive method that permits an accurate evaluation of coronary stenosis, due to a high temporal and spatial resolution. However, its sensitivity and specificity in CABG evaluation has to be clearly defined, since published studies used different protocols and scanners. We collected all studies investigating patients with stable symptoms and previous CABG and reporting the comparison between diagnostic performances of invasive coronary angiography and 64-slice-coronary computed tomography. As a result, sensitivity and specificity of 64-slice-coronary computed tomography for CABG occlusion were 0.99 (95% CI 0.97-1.00) and 0.99 (95% CI: 0.99-1.00) with an area under the curve (AUC) of 0.99. 64-slice-coronary computed tomography sensitivity and specificity for the presence of any CABG stenosis >50% were 0.98 (95% CI: 0.97-0.99) and 0.98 (95% CI: 0.96-0.98), while AUC was 0.99. At meta-regression, neither the age nor the time from graft implantation had effect on sensitivity and specificity of 64-slice-coronary computed tomography detection of significant CABG stenosis or occlusion. In conclusion 64-slice-coronary computed tomography confirmed its high sensitivity and specificity in CABG stenosis or occlusion evaluation.

Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement for Severe Aortic Stenosis in Patients With Chronic Kidney Disease Stages 3b to 5.

BACKGROUND: There are scarce data on outcomes after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in patients with renal failure. METHODS: We evaluated the impact of renal failure on outcomes after TAVI and SAVR and compared the results of these procedures in patients with chronic kidney disease stages 3b to 5 from the Observational Study of Effectiveness of AVR-TAVI Procedures for Severe Aortic Stenosis Treatment (OBSERVANT) study. RESULTS: Chronic kidney disease (CKD) stages 3b to 5 was associated with an increased risk of mortality after either TAVI or SAVR compared with CKD stages 1 to 3a. Among 170 propensity score-matched pairs with CKD stages 3b to 5, patients who underwent TAVI had a significantly higher rate of permanent pacemaker implantation, vascular damage, and mild to moderate paravalvular regurgitation, and tended to have a higher 30-day mortality (7.1% versus 2.9%; p = 0.09). Thirty-day mortality after transapical TAVI was 7.1%. SAVR had a significantly higher rate of blood transfusions, stroke, and acute kidney injury. At 2 years, patients undergoing TAVI had somewhat higher all-cause mortality (31.2% versus 23.4%; p = 0.118), major cardiac and cerebrovascular events (37.2% versus 31.0%; p = 0.270), and a lower risk of dialysis (12.4% versus 21.2%; p = 0.052) compared with SAVR. CONCLUSIONS: CKD stages 3b to 5 increases the risk of mortality after TAVI and SAVR. In this subset of patients, SAVR was associated with somewhat better early and late survival. The risk of acute kidney injury was higher after SAVR. These findings suggest that CKD stages 3b to 5 does not contraindicate SAVR. Strategies to prevent severe acute kidney injury should be implemented with either SAVR or TAVI.

Prevalence and predictors of culprit plaque rupture at OCT in patients with coronary artery disease: a meta-analysis.

AIMS: The prevalence of plaque rupture at the culprit lesion identified by optical coherence tomography (OCT) in different clinical subset of patients undergoing coronary angiography and its clinical predictors remain to be defined. METHODS: All studies including patients with OCT evaluation of the culprit coronary plaque were included. The prevalence of culprit plaque rupture (CPR) and thin-cap fibro-atheroma (TCFA) were the primary endpoints. The factors associated with these findings were studied in a subset of patients with different clinical presentations [ST-elevation myocardial (STEMI) vs. nonST-elevation myocardial infarction (NSTEMI) vs. unstable angina (UA) vs. stable angina pectoris (SAP)]. RESULTS: One hundred and fifty citations were initially appraised at the abstract level and 23 full-text studies were assessed. The mean prevalence of CPR and TCFA was 48.1% (40.5-55.8) and 48.7% (37.4-60.1), respectively. The prevalence of CPR and TCFA were higher in STEMI (70.4 and 76.6%) than in NSTEMI (55.6 and 56.3%) and UA (39.1 and 52.9%) or SAP (6.2 and 22.8%). In the overall population at meta-regression analysis, TCFA and current smoking were the only predictors of CPR (B 3.6:2.0-5.1, P < 0.001 and 0.06:0.02-0.1, P = 0.002, respectively). The factors associated with CPR were different depending on clinical presentation. Hypertension was the only clinical predictor for STEMI (B 3.3: 1.2.-5.3 P = 0.001), while advanced age (B 0.12: 0.02-0.22, P = 0.021), diabetes mellitus (B 0.04: 0.01-0.08, P = 0.012), and hyperlipidaemia (B 0.07:0.02-0.11, P = 0.005) were the predictors in NSTEMI and UA. No clinical predictor was found in SA. CONCLUSIONS: Our analysis showed high rates of CPR and TCFA detected by OCT in CAD patients, especially in those with ACS, although their prevalence is not negligible in stable patients. TCFA seems to be a strong predictor of CPR in all the ACS scenarios.