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1.
Rebecca Dann Tarik Hadi Emilie Montenont Ludovic Boytard Dornaszadat Alebrahim Jordyn Feinstein Nicole Allen Russell Simon Krista Barone Kunihiro Uryu Yu Guo Caron Rockman Bhama Ramkhelawon Jeffrey S. Berger 《Journal of the American College of Cardiology》2018,71(1):53-65
Background
Peripheral artery disease (PAD), a diffuse manifestation of atherothrombosis, is a major cardiovascular threat. Although platelets are primary mediators of atherothrombosis, their role in the pathogenesis of PAD remains unclear.Objectives
The authors sought to investigate the role of platelets in a cohort of symptomatic PAD.Methods
The authors profiled platelet activity, mRNA, and effector roles in patients with symptomatic PAD and in healthy controls. Patients with PAD and carotid artery stenosis were recruited into ongoing studies (NCT02106429 and NCT01897103) investigating platelet activity, platelet RNA, and cardiovascular disease.Results
Platelet RNA sequence profiling mapped a robust up-regulation of myeloid-related protein (MRP)-14 mRNA, a potent calcium binding protein heterodimer, in PAD. Circulating activated platelets were enriched with MRP-14 protein, which augmented the expression of the adhesion mediator, P-selectin, thereby promoting monocyte–platelet aggregates. Electron microscopy confirmed the firm interaction of platelets with monocytes in vitro and colocalization of macrophages with MRP-14 confirmed their cross talk in atherosclerotic manifestations of PAD in vivo. Platelet-derived MRP-14 was channeled to monocytes, thereby fueling their expression of key PAD lesional hallmarks and increasing their directed locomotion, which were both suppressed in the presence of antibody-mediated blockade. Circulating MRP-14 was heightened in the setting of PAD, significantly correlated with PAD severity, and was associated with incident limb events.Conclusions
The authors identified a heightened platelet activity profile and unraveled a novel immunomodulatory effector role of platelet-derived MRP-14 in reprograming monocyte activation in symptomatic PAD. (Platelet Activity in Vascular Surgery and Cardiovascular Events [PACE]; NCT02106429; and Platelet Activity in Vascular Surgery for Thrombosis and Bleeding [PIVOTAL]; NCT01897103) 相似文献2.
Hanne D. Heerkens Lisanne van Berkel Dorine S.J. Tseng Evelyn M. Monninkhof Hjalmar C. van Santvoort Jeroen Hagendoorn Inne H.M. Borel Rinkes Irene M. Lips Martijn Intven I. Quintus Molenaar 《HPB : the official journal of the International Hepato Pancreato Biliary Association》2018,20(2):188-195
Background
Surgery for pancreatic cancer yields significant morbidity and mortality risks and survival is limited. Therefore, the influence of complications on quality of life (QoL) after pancreatic surgery is important. This study compares QoL in patients with and without severe complications after surgery for pancreatic (pre-)malignancy.Methods
This prospective cohort study scored complications after pancreatic surgery according to the Clavien–Dindo system and the definitions of the International Study Group of Pancreatic Surgery. QoL was measured by the RAND36 questionnaire, the European Organization for Research and Treatment of Cancer core questionnaire (QLQ-C30) and the pancreas specific QLQ-PAN26. QoL in patients with severe complications was compared with QoL in patients with no or mild complications over a period of 12 months. Analysis was performed with linear mixed models for repeated measurements.Results
Between March 2012 and July 2016, 137 patients were included. Sixty-eight patients (50%) had at least 1 severe complication. There were no statistically significant and clinically relevant differences between both groups in QoL up to 12 months after surgery.Conclusion
In this study, no differences in QoL between patients with and without severe postoperative complications were encountered during the first 12 months after surgery for pancreatic (pre-)malignancy.3.
John K. Forrest Abeel A. Mangi Jeffrey J. Popma Kamal Khabbaz Michael J. Reardon Neal S. Kleiman Steven J. Yakubov Daniel Watson Susheel Kodali Isaac George Peter Tadros George L. Zorn John Brown Robert Kipperman Sara Saul Hongyan Qiao Jae K. Oh Mathew R. Williams 《JACC: Cardiovascular Interventions》2018,11(2):160-168
Objectives
This study sought to evaluate the Medtronic Evolut PRO Transcatheter Aortic Valve System in patients with severe symptomatic aortic stenosis.Background
A next-generation self-expanding transcatheter aortic valve was designed with an external pericardial wrap with the intent to reduce paravalvular leak while maintaining the benefits of a low-profile, self-expanding, and repositionable supra-annular valve.Methods
The Medtronic Evolut PRO Clinical Study included 60 patients undergoing transcatheter aortic valve replacement with the Evolut PRO valve at 8 investigational sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. The 2 primary safety endpoints were the incidence of all-cause mortality at 30 days and the incidence of disabling stroke at 30 days. The primary efficacy endpoint was the proportion of patients with no or trace prosthetic valve regurgitation at 30 days. An independent echocardiographic core laboratory (Mayo Clinic, Rochester, Minnesota) was used to adjudicate all echocardiographic assessments.Results
All 60 patients received the Evolut PRO valve. At 30 days, 1 patient (1.7%) died and 1 patient (1.7%) experienced a nonfatal disabling stroke. Paravalvular regurgitation at 30 days was absent or trace in 72.4% of patients and was mild in the remainder of patients, with no patients having worse than mild paravavlular leak. The mean atrioventricular gradient was 6.4 ± 2.1 mm Hg and effective orifice area was 2.0 ± 0.5 cm2 at 30 days.Conclusions
The safety and efficacy results of this study support the use of the Evolut PRO System for the treatment of severe symptomatic aortic stenosis in patients who are at increased surgical risk, resulting in excellent hemodynamics and minimal paravalvular leak (The Medtronic TAVR 2.0 US Clinical Study; NCT02738853) 相似文献4.
Chetana Lim Chady Salloum Michael Osseis Eylon Lahat Concepción Gómez-Gavara Philippe Compagnon Alain Luciani Cyrille Feray Daniel Azoulay 《HPB : the official journal of the International Hepato Pancreato Biliary Association》2018,20(3):222-230
Background
Western guidelines recommend resection for hepatocellular carcinoma (HCC) in so-called ideal cirrhotic patients with a Barcelona Clinic Liver Cancer (BCLC) stage 0-A tumour. This study compares short-term outcomes following resection between patients defined as ideal and nonideal according to the BCLC guidelines.Methods
This prospective single-centre open study (ClinicalTrials.govNCT02145013) included all cirrhotic patients with HCC referred for resection from 2014 to 2016. Mortality, morbidity, unresolved liver decompensation, and readmission were measured.Results
The study population included 65 consecutive patients: 32 (49%) ideal and 33 (51%) nonideal. Ideal and nonideal groups did not differ in mortality (3% vs. 6%; p = 0.57), morbidity (53% vs. 73%; p = 0.10), or unresolved liver decompensation (6% vs. 15%; p = 0.23) at 90 days. The readmission rate was higher in the nonideal (21%) than in the ideal group (3%; p = 0.02).Conclusion
Straying from the current guidelines for resection in a selected subset of nonideal patients doubled the number of resections performed for treating HCC, with satisfactory short-term outcomes. These results argue for the expansion of the acknowledged BCLC guidelines. 相似文献5.
Philip D. Adamson David E. Newby C. Larry Hill Adrian Coles Pamela S. Douglas Christopher B. Fordyce 《JACC: Cardiovascular Imaging》2018,11(9):1301-1310
Objectives
This study sought to compare the performance of major guidelines for the assessment of stable chest pain including risk-based (American College of Cardiology/American Heart Association and European Society of Cardiology) and symptom-focused (National Institute for Health and Care Excellence) strategies.Background
Although noninvasive testing is not recommended in low-risk individuals with stable chest pain, guidelines recommend differing approaches to defining low-risk patients.Methods
Patient-level data were obtained from the PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) and SCOT-HEART (Scottish Computed Tomography of the Heart) trials. Pre-test probability was determined and patients dichotomized into low-risk and intermediate-high–risk groups according to each guideline’s definitions. The primary endpoint was obstructive coronary artery disease on coronary computed tomography angiography. Secondary endpoints were coronary revascularization at 90 days and cardiovascular death or nonfatal myocardial infarction up to 3 years.Results
In total, 13,773 patients were included of whom 6,160 had coronary computed tomography angiography. The proportions of patients identified as low risk by the American College of Cardiology/American Heart Association, European Society of Cardiology, and National Institute for Health and Care Excellence guidelines, respectively, were 2.5%, 2.5%, and 10.0% within PROMISE, and 14.0%, 19.8%, and 38.4% within SCOT-HEART. All guidelines identified lower rates of obstructive coronary artery disease in low- versus intermediate-high–risk patients with a negative predictive value of ≥0.90. Compared with low-risk groups, all intermediate-high–risk groups had greater risks of coronary revascularization (odds ratio [OR]: 2.2 to 24.1) and clinical outcomes (OR: 1.84 to 5.8).Conclusions
Compared with risk-based guidelines, symptom-focused assessment identifies a larger group of low-risk chest pain patients potentially deriving limited benefit from noninvasive testing. (Scottish Computed Tomography of the Heart Trial [SCOT-HEART]; NCT01149590; Prospective Multicenter Imaging Study for Evaluation of Chest Pain [PROMISE]; NCT01174550) 相似文献6.
Ingo Eitel Thomas Stiermaier Torben Lange Karl-Philipp Rommel Alexander Koschalka Johannes T. Kowallick Joachim Lotz Shelby Kutty Matthias Gutberlet Gerd Hasenfuß Holger Thiele Andreas Schuster 《JACC: Cardiovascular Imaging》2018,11(10):1433-1444
Objectives
The aims of the study were to assess the prognostic significance of cardiac magnetic resonance myocardial feature tracking (CMR-FT) in a large multicenter study and to evaluate the most potent CMR-FT predictor of hard clinical events following myocardial infarction (MI).Background
CMR-FT is a new method that allows accurate assessment of global and regional circumferential, radial, and longitudinal myocardial strain. The prognostic value of CMR-FT in patients with reperfused MI is unknown.Methods
The study included 1,235 MI patients (n = 795 with ST-segment elevation MI and 440 with non–ST-elevation MI) at 15 centers. All patients were reperfused by primary percutaneous coronary intervention. Central core laboratory–masked analyses were performed to determine left ventricular (LV) circumferential, radial, and longitudinal strain. The primary clinical endpoint of the study was the occurrence of major adverse cardiac events within 12 months after infarction.Results
Patients with cardiovascular events had significantly impaired CMR-FT strain values (p < 0.001 for all). Global longitudinal strain was identified as the strongest CMR-FT parameter of future cardiovascular events and emerged as an independent predictor of poor prognosis following MI even after adjustment for established prognostic markers. Global longitudinal strain provided an incremental prognostic value for all-cause mortality above LV ejection fraction (c-index increase from 0.65 to 0.73; p = 0.04) and infarct size (c-index increase from 0.60 to 0.78; p = 0.002).Conclusions
CMR-FT is a superior measure of LV function and performance early after reperfused MI with incremental prognostic value for mortality over and above LV ejection fraction and infarct size. (Abciximab i.v. Versus i.c. in ST-segment elevation Myocardial Infarction [AIDA STEMI]; NCT00712101; Thrombus Aspiration in ThrOmbus Containing culpRIT Lesions in Non-ST-Elevation Myocardial Infarction [TATORT-NSTEMI]; NCT01612312) 相似文献7.
Vallerie V. McLaughlin Marius M. Hoeper Richard N. Channick Kelly M. Chin Marion Delcroix Sean Gaine Hossein-Ardeschir Ghofrani Pavel Jansa Irene M. Lang Sanjay Mehta Tomás Pulido B.K.S. Sastry Gérald Simonneau Olivier Sitbon Rogério Souza Adam Torbicki Victor F. Tapson Loïc Perchenet Nazzareno Galiè 《Journal of the American College of Cardiology》2018,71(7):752-763
Background
Registry data suggest that disease progression in pulmonary arterial hypertension (PAH) is indicative of poor prognosis. However, the prognostic relevance of PAH-related morbidity has not been formally evaluated in randomized controlled trials.Objectives
The purpose of these analyses was to assess the impact of morbidity events on the risk of subsequent mortality using the landmark method and data from the SERAPHIN and GRIPHON studies.Methods
For each study, the risk of all-cause death up to the end of the study was assessed from the landmark time point (months 3, 6, and 12) according to whether a patient had experienced a primary endpoint morbidity event before the landmark. Each analysis was conducted using data from all patients who were available for survival follow-up at the landmark.Results
In the SERAPHIN study, on the basis of the 3-month landmark time point, patients who experienced a morbidity event before month 3 had an increased risk of death compared with patients who did not (hazard ratio [HR]: 3.39; 95% confidence interval [CI]: 1.94 to 5.92). In the GRIPHON study, on the basis of the 3-month landmark time point, there was also an increased risk with a HR of 4.48; (95% CI: 2.98 to 6.73). Analyses based on 6-month and 12-month landmarks also showed increased risk in patients who experienced morbidity events, albeit with a reduced HR.Conclusions
These results demonstrate the prognostic relevance of PAH-related morbidity as defined in the SERAPHIN and GRIPHON studies, highlighting the importance of preventing disease progression in patients with PAH and supporting the clinical relevance of SERAPHIN and GRIPHON morbidity events. (Study of Macitentan [ACT-064992] on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension [SERAPHIN]; NCT00660179; Selexipag [ACT-293987] in Pulmonary Arterial Hypertension [GRIPHON]; NCT01106014) 相似文献8.
Vinayak Bapat Vivek Rajagopal Christopher Meduri R. Saeid Farivar Antony Walton Stephen J. Duffy Robert Gooley Aubrey Almeida Michael J. Reardon Neal S. Kleiman Konstantinos Spargias Stratis Pattakos Martin K. Ng Michael Wilson David H. Adams Martin Leon Michael J. Mack Sharla Chenoweth Simon Redwood 《Journal of the American College of Cardiology》2018,71(1):12-21
Background
Transcatheter mitral valve replacement (TMVR) is a potential therapy for patients with symptomatic, severe mitral regurgitation (MR). The feasibility of this therapy remains to be defined.Objectives
The authors report their early experience with TMVR using a new valve system.Methods
The valve is a self-expanding, nitinol valve with bovine pericardial leaflets that is placed using a transapical delivery system. Patients with symptomatic MR who were deemed high or extreme risk by the local heart teams were enrolled in a global pilot study at 14 sites (United States, Australia, and Europe).Results
Fifty consecutively enrolled patients (mean age: 73 ± 9 years; 58.0% men; 84% secondary MR) underwent TMVR with the valve. The mean Society for Thoracic Surgery score was 6.4 ± 5.5%; 86% of patients were New York Heart Association functional class III or IV, and the mean left ventricular ejection fraction was 43 ± 12%. Device implant was successful in 48 patients with a median deployment time of 14 min (interquartile range: 12 to 17 min). The 30-day mortality was 14%, with no disabling strokes, or repeat interventions. Median follow-up was 173 days (interquartile range: 54 to 342 days). At latest follow-up, echocardiography confirmed mild or no residual MR in all patients who received implants. Improvements in symptom class (79% in New York Heart Association functional class I or II at follow-up; p < 0.0001 vs. baseline) and Minnesota Heart Failure Questionnaire scores (56.2 ± 26.8 vs. 31.7 ± 22.1; p = 0.011) were observed.Conclusions
TMVR with the valve was feasible in a study group at high or extreme risk for conventional mitral valve replacement. These results inform trial design of TMVR in lower-risk patients with severe mitral valve regurgitation (Evaluation of the Safety and Performance of the Twelve Intrepid Transcatheter Mitral Valve Replacement System in High Risk Patients with Severe, Symptomatic Mitral Regurgitation – The Twelve Intrepid TMVR Pilot Study; NCT02322840) 相似文献9.
Julie N. Leal Eran Sadot Mithat Gonen Stuart Lichtman T. Peter Kingham Peter J. Allen Ronald P. DeMatteo William R. Jarnagin Michael I. D&#x;Angelica 《HPB : the official journal of the International Hepato Pancreato Biliary Association》2017,19(2):162-169
Background
Clinical outcomes of octogenarians undergoing hepatectomy for colorectal liver metastases (CRLM) are poorly characterized. The current study evaluated operative morbidity, mortality and survival outcomes among a contemporary cohort of octogenarians.Methods
Patients undergoing their first hepatectomy for CRLM were identified from institutional databases and those ≥80 years old (y) were matched 1:1 to a group of patients <80 y. Data pertaining to surgical morbidity/mortality and survival were compared using standard statistical methods.Results
From 2002 to 2012, 1391 hepatectomies were performed for CRLM, 55 (4%) in patients ≥80 y. Major complications occurred twice as frequently among patients ≥80 y [10 (19%) ≥80 y versus 5 (9%) <80 y, (p = 0.270)]. No matched patient <80 y. died within 90 d of operation, whereas, 4 (7%) patients ≥80 y did, p = 0.125. Median follow-up was significantly longer for the <80 y group [44 (1–146) versus. 23 (0–102) mths, p = 0.006]. Probability of disease recurrence was not different between groups (p = 0.123) nor was the cumulative incidence of death from disease (p = 0.371). However, patients ≥80 y had significantly higher incidence of non-cancer related death (p = 0.012).Conclusions
Hepatectomy for CRLM among well-selected octogenarians is reasonable with cancer related survival outcomes similar to those observed in younger patients. However, it is associated with clinically significant morbidity/mortality and continued efforts directed at optimizing perioperative care are necessary to improve early outcomes among octogenarians. 相似文献10.
Carlo Pappone Giuseppe Ciconte Francesco Manguso Gabriele Vicedomini Valerio Mecarocci Manuel Conti Luigi Giannelli Paolo Pozzi Valeria Borrelli Lorenzo Menicanti Zarko Calovic Giuseppe Della Ratta Josep Brugada Vincenzo Santinelli 《Journal of the American College of Cardiology》2018,71(15):1631-1646
Background
Guidelines recommend the use of implanted cardioverter-defibrillators in patients with Brugada syndrome and induced ventricular tachyarrhythmias, but there is no evidence supporting it.Objectives
This prospective registry study was designed to explore clinical and electrophysiological predictors of malignant ventricular tachyarrhythmia inducibility in Brugada syndrome.Methods
A total of 191 consecutive selected patients with (group 1; n = 88) and without (group 2; n = 103) Brugada syndrome–related symptoms were prospectively enrolled in the registry. Patients underwent electrophysiological study and substrate mapping or ablation before and after ajmaline testing (1 mg/kg/5 min).Results
Overall, before ajmaline testing, 53.4% of patients had ventricular tachyarrhythmia inducibility, which was more frequent in group 1 (65.9%) than in group 2 (42.7%; p < 0.001). Regardless of clinical presentation, larger substrates with more fragmented long-duration ventricular potentials were found in patients with inducible arrhythmias than in patients without inducible arrhythmias (p < 0.001). One extrastimulus was used in more extensive substrates (median 13 cm2; p < 0.001), and ventricular fibrillation was the more frequently induced rhythm (p < 0.001). After ajmaline, patients without arrhythmia inducibility had arrhythmia inducibility without a difference in substrate characteristics between the 2 groups. The substrate size was the only independent predictor of inducibility (odds ratio: 4.51; 95% confidence interval: 2.51 to 8.09; p < 0.001). A substrate size of 4 cm2 best identified patients with inducible arrhythmias (area under the curve: 0.98; p < 0.001). Substrate ablation prevented ventricular tachyarrhythmia reinducibility.Conclusions
In Brugada syndrome dynamic substrate variability represents the pathophysiological basis of lethal ventricular tachyarrhythmias. Substrate size is independently associated with arrhythmia inducibility, and its determination after ajmaline identifies high-risk patients missed by clinical criteria. Substrate ablation is associated with electrocardiogram normalization and not arrhythmia reinducibility. (Epicardial Ablation in Brugada Syndrome [BRUGADA_I]; NCT02641431; Epicardial Ablation in Brugada Syndrome: An Extension Study of 200 BrS Patients; NCT03106701) 相似文献11.
A. Fortin R. Rabasa-Lhoret S. Lemieux M.-E. Labonté V. Gingras 《Nutrition, metabolism, and cardiovascular diseases : NMCD》2018,28(12):1275-1284
Background and aims
The metabolic syndrome (MS) is an emerging complication in patients with type 1 diabetes (T1D), with no preventive or therapeutic treatment reported yet. We wanted to compare the impact of two 6-month nutritional interventions, based on a Mediterranean (MED) or a low-fat diet, on waist circumference, anthropometric and metabolic outcomes in patients with both T1D and the MS.Methods and results
Participants were randomized into 2 intervention groups: 1) MED-diet or 2) low-fat diet. The 6-month study included 9 teaching sessions with a registered dietitian. Anthropometric (primary outcome: waist circumference), metabolic and nutritional assessments were performed at inclusion, 3 and 6-month. We used mixed effects models to assess the effects of both interventions. 28 participants were included (50.9 ± 10.3 years old) with a mean BMI of 30.7 ± 3.3 kg/m2 and a waist circumference of 105.5 ± 8.9 cm at inclusion. A trend towards a greater reduction of dietary fat intakes in the low-fat diet group was observed (P-interaction = 0.09). Waist circumference was reduced at 6-month in both groups (?3.5 cm low-fat; ?1.5 cm MED-diet) with no significant difference between groups (P-interaction = 0.43). Body mass index also significantly decreased in both groups (?0.7 kg/m2 low-fat; ?1.1 kg/m2 MED-diet; P-interaction = 0.56). No significant differences between groups were observed for other metabolic parameters.Conclusions
This study suggests that a 6-month non-restrictive dietary intervention in patients with T1D and MS could contribute to weight management, without significant differences between interventions for anthropometric and metabolic parameters. Further studies should investigate the long-term benefits of these diets.12.
J.M. McCaffery J.M. Ordovas G.S. Huggins C.-Q. Lai M.A. Espeland D.F. Tate R.R. Wing 《Nutrition, metabolism, and cardiovascular diseases : NMCD》2018,28(8):816-821
Background and Aims
Two weight gain prevention strategies, one targeting small changes to diet and physical activity and a second targeting large changes, significantly reduced weight gain in young adulthood. We examined whether weight gain prevention blunts genetic risk for body weight increase and/or high density lipoprotein cholesterol (HDL-C) lowering over two years.Methods and Results
Participants were 524 male and female young adults (mean age = 28.2, SD = 4.3; mean BMI = 25.5, SD = 2.6). Obesity-related SNPs accounting for ≥ 0.04% of the variance were genotyped and combined into a genetic risk score. For HDL-C, SNPs within CETP, LIPC and FADS2 were genotyped. The obesity-related genetic risk score did not predict change in BMI independently or in interaction with treatment arm. However, consistent with the prior literature, each copy of the HDL-C risk, C, allele at CETP rs3764261 was associated with lower HDL-C at baseline. Moreover, significant interaction between SNP and treatment arm for change in HDL-C was observed (p = 0.02). In the control group, HDL-C change was dependent upon rs3764261 (p = 0.004) with C allele carriers showing a continued reduction in HDL-C. In contrast, within the two intervention groups, HDL-C increased on average with no differential effect of rs3764261 (p > 0.24). Notably, even among carriers of the CC genotype, small and large change arms were associated with increased HDL-C and the control arm a reduction (p = 0.013).Conclusions
The C allele at CETP rs3764261 is a strong risk factor for low HDL-C in young adulthood but weight gain prevention may mitigate this risk.Clinical Trial Registry number and website
clinicaltrials.gov Identifier: NCT01183689, https://clinicaltrials.gov/ 相似文献13.
Robbert J. de Winter Jaya Chandrasekhar Deborah N. Kalkman Melissa B. Aquino Pier Woudstra Marcel A. Beijk Samantha Sartori Usman Baber Jan G. Tijssen Karel T. Koch George D. Dangas Antonio Colombo Roxana Mehran 《JACC: Cardiovascular Interventions》2018,11(19):1969-1978
Objectives
The aim of this study was to evaluate 1-year clinical safety and efficacy of the dual-therapy COMBO stent in a large, all-comers patient-level pooled cohort.Background
The COMBO stent (OrbusNeich Medical, Fort Lauderdale, Florida) is a novel stent with abluminal sirolimus elution from a biodegradable polymer and a luminal pro-healing anti-CD34+ antibody layer, which attracts circulating endothelial progenitor cells. These endothelial progenitor cells can quickly mature into normal endothelium, providing rapid endothelialization.Methods
The MASCOT (Multinational Abluminal Sirolimus Coated biO-engineered stenT) (N = 2,614, 61 global sites) and REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt Post Market Registry) (N = 1,000, 9 European sites) registries are 2 prospective, multicenter studies evaluating clinical outcomes after attempted COMBO stent placement in all-comer patients undergoing percutaneous coronary intervention. In this patient-level pooled analysis we analyzed 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Furthermore, we determined predictors of 1-year TLF.Results
A total of 3,614 patients (63.5 ± 11.2 years of age; 23.8% women) were included in this analysis. The prevalence of diabetes mellitus was 29.3%, and 54.3% patients presented with acute coronary syndrome. The primary endpoint of 1-year TLF occurred in 140 (3.9%) patients, with incidence of cardiac death in 1.6%, target vessel myocardial infarction in 1.2%, clinically driven target lesion revascularization in 2.2%, and definite stent thrombosis in 0.5% patients. Insulin-treated diabetes mellitus, chronic renal failure, and American College of Cardiology/American Heart Association lesion type B2/C were independent predictors of 1-year TLF.Conclusions
In this large patient-level pooled analysis of patients treated with the dual-therapy COMBO stent excellent results at 1-year were observed. (MASCOT - Post Marketing Registry [MASCOT]; NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the COMBO Stent [REMEDEE Reg]; NCT01874002) 相似文献14.
Masayuki Okuno Claire Gourmard Takashi Mizuno Kiyohiko Omichi Ching-Wei D. Tzeng Yun Shin Chun Jeffrey E. Lee Jean-Nicolas Vauthey Claudius Conrad 《HPB : the official journal of the International Hepato Pancreato Biliary Association》2018,20(1):57-63
Background
Risk factors for pathological diaphragmatic invasion from colorectal liver metastases (CRLM) and differences in recurrence patterns and survival between patients with true pathological diaphragmatic invasion versus inflammatory adhesions only remain poorly understood. This study aimed at identifying risk factors for and survival impact of pathological diaphragmatic invasion in patients with CRLM.Methods
Patients with CRLM who underwent hepatectomy with or without diaphragmatic resection from 1998 to 2015 were retrospectively analyzed. Recurrence-free survival (RFS), overall survival (OS), and recurrence patterns were examined according to the presence or absence of pathological invasion.Results
Of 1860 patients, 70 underwent hepatectomy with diaphragmatic resection and 1799 had hepatectomy only. Among the patients with gross diaphragmatic involvement, 15 (21%) had pathological invasion, and 55 (79%) had inflammatory adhesion only. Multiple tumors (p = 0.019) and RAS mutation (p = 0.047) were significantly associated with pathological invasion. Pathological invasion was associated with a higher incidence of peritoneal recurrence (33% vs. 11%, p = 0.041), worse median RFS (6 months vs. 11 months, p = 0.21) and OS (26 months vs. 51 months, p = 0.046) compared to inflammatory adhesion.Conclusion
Multiple tumors and RAS mutant were predictors for pathological diaphragmatic invasion, which was associated with a higher incidence of peritoneal recurrence and worse OS. 相似文献15.
Pierluigi Tricoci L. Kristin Newby Robert M. Clare Sergio Leonardi C. Michael Gibson Robert P. Giugliano Paul W. Armstrong Frans Van de Werf Gilles Montalescot David J. Moliterno Claes Held Philip E. Aylward Lars Wallentin Robert A. Harrington Eugene Braunwald Kenneth W. Mahaffey Harvey D. White 《JACC: Cardiovascular Interventions》2018,11(9):856-864
Objectives
In 13,038 patients with non–ST-segment elevation acute coronary syndrome undergoing index percutaneous coronary intervention (PCI) in the EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non–ST-Segment Elevation Acute Coronary Syndrome) and TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) trials, the relationship between PCI-related myocardial infarction (MI) and 1-year mortality was assessed.Background
The definition of PCI-related MI is controversial. The third universal definition of PCI-related MI requires cardiac troponin >5 times the 99th percentile of the normal reference limit from a stable or falling baseline and PCI-related clinical or angiographic complications. The definition from the Society for Cardiovascular Angiography and Interventions (SCAI) requires creatine kinase–MB elevation >10 times the upper limit of normal (or 5 times if new electrocardiographic Q waves are present). Implications of these definitions on prognosis, prevalence, and implementation are not established.Methods
In our cohort of patients undergoing PCI, PCI-related MIs were classified using the third universal type 4a MI definition and SCAI criteria. In the subgroup of patients included in the angiographic core laboratory (ACL) substudy of EARLY ACS (n = 1,401) local investigator– versus ACL-reported angiographic complications were compared.Results
Altogether, 2.0% of patients met third universal definition of PCI-related MI criteria, and 1.2% met SCAI criteria. One-year mortality was 3.3% with the third universal definition (hazard ratio: 1.96; 95% confidence interval: 1.24 to 3.10) and 5.3% with SCAI criteria (hazard ratio: 2.79; 95% confidence interval: 1.69 to 4.58; p < 0.001). Agreement between ACL and local investigators in detecting angiographic complications during PCI was overall moderate (κ = 0.53).Conclusions
The third universal definition of MI and the SCAI definition were both associated with significant risk for mortality at 1 year. Suboptimal concordance was observed between ACL and local investigators in identifying patients with PCI complications detected on angiography. (Trial to Assess the Effects of Vorapaxar [SCH 530348; MK-5348] in Preventing Heart Attack and Stroke in Participants With Acute Coronary Syndrome [TRA·CER] [Study P04736]; NCT00527943; EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non–ST-Segment Elevation Acute Coronary Syndrome [Study P03684AM2]; NCT00089895) 相似文献16.
Mégane Lemaire Valerio Lucidi Fikri Bouazza Georgios Katsanos Bruno Vanderlinden Hugo Levillain Philippe Delatte Camilo A. Garcia Michael Vouche Maria Gomez Galdon Pieter Demetter Amélie Deleporte Alain Hendlisz Patrick Flamen Vincent Donckier 《HPB : the official journal of the International Hepato Pancreato Biliary Association》2018,20(7):641-648
Background/Purpose
Preoperative selective internal radiation therapy (SIRT) may improve the results of partial hepatectomy (PH) or radiofrequency destruction (RF) for hepatocellular carcinoma (HCC) in patients with cirrhosis. The aim of this study was to evaluate the feasibility and safety of this combined approach.Methods
Patients with cirrhosis and HCC selected for PH or RF were prospectively included and systematically proposed for preoperative SIRT. Feasibility and safety of SIRT and post-SIRT PH or RF were assessed.Results
Thirty patients were included. SIRT was contraindicated in seven, due to lack of access to tumour artery or to hepato-pulmonary shunts. SIRT was performed in 23 patients without significant complications. Post-SIRT, surgery was refuted in seven patients, due to tumour progression or the patient's deteriorating condition. After surgery, major complications were observed in 2/16 patients (12.5%) and one patient died 52 days post-surgery. A major tumour pathological response was seen in most patients who underwent surgery after SIRT.Conclusions
On intention-to-treat basis, the overall feasibility of combining preoperative SIRT and surgery was limited. Preoperative SIRT did not increase expected operative morbidity, but post-SIRT, a third of patients were refuted for surgery. Accurate selection criteria and potential long-term oncological benefit of this approach remains to be determined.ClinicalTrials.gov NCT01686880. 相似文献17.
Kartik S. Jhaveri Sandra E. Fischer Hooman Hosseini-Nik Boraiah Sreeharsha Ravi J. Menezes Steven Gallinger Carol-Anne E. Moulton 《HPB : the official journal of the International Hepato Pancreato Biliary Association》2017,19(11):992-1000
Objective
To prospectively compare the diagnostic performance of gadoxetic acid-enhanced MRI (EOB-MRI) and contrast-enhanced CT (CECT) for preoperative detection of colorectal liver metastases (CRLM) following chemotherapy and to evaluate the potential change in the hepatic resection plan.Methods
51 patients with CRLM treated with preoperative chemotherapy underwent liver imaging by EOB-MRI and CECT prospectively. Two independent blinded readers characterized hepatic lesions on each imaging modality using a 5-point scoring system. 41 patients underwent hepatic resection and histopathological evaluation.Results
151 CRLM were confirmed by histology. EOB-MRI, compared to CECT, had significantly higher sensitivity in detection of CRLM ≤1.0 cm (86% vs. 45.5%; p < 0.001), significantly lower indeterminate lesions diagnosis (7% vs. 33%; p < 0.001) and significantly higher interobserver concordance rate in characterizing the lesions ≤1.0 cm (72% vs. 51%; p = 0.041). The higher yield of EOB-MRI could have changed the surgical plan in 45% of patients.Conclusion
Following preoperative chemotherapy, EOB-MRI is superior to CECT in detection of small CRLM (≤1 cm) with significantly higher sensitivity and diagnostic confidence and interobserver concordance in lesion characterization. This improved diagnostic performance can alter the surgical plan in almost half of patients scheduled for liver resection. 相似文献18.
Ganesh Manoharan Nicolas M. Van Mieghem Stephan Windecker Johan Bosmans Sabine Bleiziffer Thomas Modine Axel Linke Werner Scholtz Bernard Chevalier Robert Gooley Cathy Zeng Jae K. Oh Eberhard Grube 《JACC: Cardiovascular Interventions》2018,11(22):2326-2334
Objectives
This study sought to report the 1-year safety and efficacy outcomes in the FORWARD (CoreValve Evolut R FORWARD) study following transcatheter aortic valve replacement (TAVR) with the next-generation Evolut R device (Medtronic, Minneapolis, Minnesota) in routine clinical practice.Background
The FORWARD study reported low incidences of mortality, disabling stroke, and significant paravalvular leak following TAVR in routine clinical practice at 30 days. Longer-term results in large patient populations with the Evolut R self-expanding, repositionable transcatheter heart valve (THV) are lacking.Methods
This was a prospective, single-arm, multinational, multicenter, observational study investigating efficacy and safety following TAVR with the next-generation self-expanding THV. Between January and December 2016, 1,040 patients underwent attempted implant of the Evolut R self-expanding repositionable valve at 53 sites worldwide. An independent Clinical Events Committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms.Results
The mean age was 81.8 ± 6.2 years, 64.8% were women, and patients had a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.5 ± 4.5% and EuroSCORE II of 5.7 ± 5.0%. The 1-year all-cause mortality rate was 8.9%, with a cardiovascular mortality rate of 6.9%. At 1 year, the incidence of disabling stroke was 2.1%, and a pacemaker was implanted in 19.7% of patients. The incidence of more than mild paravalvular leak was 1.2%.Conclusions
The FORWARD study demonstrated good safety and efficacy profiles for the next-generation Evolut R THV up to 1-year follow-up, with very low mortality and adverse events. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369) 相似文献19.
Kiyoshi Hibi Ken Kozuma Shinjo Sonoda Tsutomu Endo Hiroyuki Tanaka Hiroyuki Kyono Ryoji Koshida Takayuki Ishihara Masaki Awata Teruyoshi Kume Kengo Tanabe Yoshihiro Morino Kengo Tsukahara Yuji Ikari Kenshi Fujii Masao Yamasaki Takeharu Yamanaka Kazuo Kimura Takaaki Isshiki 《JACC: Cardiovascular Interventions》2018,11(16):1545-1555
Objectives
The aim of this study was to evaluate the utility of distal protection during percutaneous coronary intervention (PCI) in patients with acute coronary syndromes at high risk for distal embolization.Background
The results of previous clinical trials indicated that the routine use of distal protection in patients with ST-segment elevation myocardial infarction did not improve clinical outcomes. However, selective use of distal protection by means of a filter-based distal protection system has not been evaluated.Methods
Two hundred patients with acute coronary syndromes who had native coronary artery lesions and attenuated plaque with longitudinal length ≥5 mm on pre-PCI intravascular ultrasound were randomly assigned to undergo PCI with distal protection or conventional treatment.Results
The primary endpoint (no-reflow phenomenon) occurred in 26 patients (26.5%) in the distal protection group and 39 patients (41.7%) in the conventional treatment group (p = 0.026), and the corrected TIMI (Thrombolysis In Myocardial Infarction) frame count after revascularization was significantly lower in the distal protection group (23 vs. 30.5; p = 0.0003). The incidence of cardiac death, cardiac arrest, cardiogenic shock after revascularization requiring defibrillation, cardiopulmonary resuscitation, or extracorporeal membrane oxygenation was significantly lower in the distal protection group than in the conventional treatment group (0% vs. 5.2%; p = 0.028).Conclusions
The use of distal embolic protection applied with a filter device decreased the incidence of the no-reflow phenomenon and was associated with fewer serious adverse cardiac events after revascularization than conventional PCI in patients with acute coronary syndromes with attenuated plaque ≥5 mm in length. (Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome [ACS] [VAMPIRE3]; NCT01460966) 相似文献20.
Dominik Buckert Simon Witzel Jürgen M. Steinacker Wolfgang Rottbauer Peter Bernhardt 《JACC: Cardiovascular Imaging》2018,11(7):987-996