Vascular complications and bleeding after balloon aortic valvuloplasty performed with or without heparin: HEPAVALVE randomized study.

Background: Vascular and bleeding events remain the main complications after balloon aortic valvuloplasty (BAV). While BAV is usually performed with per procedural heparin injection, BAV performed without heparin may reduce hemorrhagic events. We aimed to determine whether vascular and bleeding complications may be reduced with BAV performed without heparin. Methods: This randomized, double-blind, placebo-controlled study was conducted from January 2013 to September 2016. Patients were randomly assigned to placebo or intravenous unfractionated heparin (UH) 50 IU/kg bolus during the procedure. The primary endpoint included major vascular, bleeding and ischemic complications (stroke, transient ischemic attack, myocardial infarction) according to VARC-2 criteria. Results: Among 89 randomized patients, 82 completed the study (n = 39 in the UH group and n = 43 in the placebo group). At baseline, diabetes, sex male and renal failure were more frequent in the UH group and peripheral artery disease was more frequent in the placebo group. The primary endpoint was achieved in 7 patients (8.5%), 1 in the placebo group (2.3%) versus 6 in the UH group (15.4%). After adjustment on diabetes, sex, renal failure, peripheral artery disease, percutaneous closure device and chronic obstructive pulmonary disease, UH utilization was associated with a significant risk of major vascular, bleeding and ischemic complications (primary endpoint) (adjOR: 11.9; 95%CI: 1.2-117.2; p = 0.03). Hospitalization length was lower in the placebo group compared to the UH group (p = 0.03). Conclusions: BAV without per procedural UH was associated with a reduction of major VC and bleeding events without increasing the ischemic risk and with a shorter hospitalization length.

Colchicine to Prevent Sympathetic Denervation after an Acute Myocardial Infarction: The COLD-MI Trial Protocol.

Inflammatory processes are deeply involved in ischemia-reperfusion injuries (IRI) and ventricular remodelling (VR) after a ST-segment elevation myocardial infarction (STEMI). They are associated with clinical adverse events (heart failure and cardiovascular death) adding damage to the myocardium after reperfusion. Moreover, acute myocardial infarction (AMI) induces a local sympathetic denervation leading to electrical instability and arrythmia. Colchicine, a well-known alkaloid with direct anti-inflammatory effects, was shown to reduce the myocardial necrosis size and limit the VR. In a recent proof of concept study, colchicine appears to prevent sympathetic denervation in a mice model of ischemia/reperfusion, but not in the necrosis or in the border zone areas. The Colchicine to Prevent Sympathetic Denervation after an AMI study (COLD-MI) is an ongoing, confirmative, prospective, monocentre, randomized, open-label trial. The COLD-MI trial aims to evaluate the intensity of sympathetic denervation after AMI and its potential modulation due to low dose colchicine. Sympathetic denervation will be noninvasively evaluated using single-photon emission computed tomography (SPECT). After a first episode of STEMI (Initial TIMI flow ≤ 1) and primary percutaneous coronary intervention (PPCI), patients will be randomized (n = 56) in a 1:1 ratio to either receive colchicine or not for 30 days. The primary end point will be the percentage of myocardial denervation measured by 123I-metaiodobenzylguanidine (123I-MIBG) SPECT at a 6-month follow-up. The main secondary end points will be basic ECG parameters (QRS duration, corrected QT) and HRV parameters from a 24 hour-recording Holter at 1- and 6-months follow-up. Results from this study will contribute to a better understanding of the cardioprotective effect of colchicine after AMI. The present study describes the rationale, design, and methods of the trial.

Use and outcomes of the PK Papyrus covered stent in France: SOS PK Papyrus Registry.

OBJECTIVES: To evaluate the rate of procedural success and long-term outcomes of the PK Papyrus (PKP) covered stent (CS). BACKGROUND: CS are essential in the treatment of coronary artery perforation (CAP). They have also been used to treat coronary artery aneurysms. Limited evidence is available on clinical outcomes with the PKP. METHODS: This was a multicenter, observational, retrospective, and prospective study. Consecutive patients undergoing intentional PKP implantation in 22 centers in France were included. The primary endpoint was the rate of procedural success. Secondary endpoints included rates of death, myocardial infarction (MI), target lesion revascularization (TLR), in-stent restenosis (ISR), and stent thrombosis (ST). RESULTS: Data from 130 patients were analyzed (mean age 72.5 ± 10.5 years; 71% men). The main indication for PKP was CAP, in 84 patients (65%). Delivery success was achieved in 95% and procedural success in 91%. During the in-hospital stay, 15 patients died (12%) and 7 (5%) presented with ST. Data from 127 patients were available at 19.2 ± 12.8 month follow-up. Thirty-three patients died (26%), 15 (12%) had an MI and 21 (17%) presented with TLR. TLR was due to ISR in 12 patients (9%), 10 had definite ST (8%) and 1 patient for stent under-expansion. CONCLUSIONS: The principal indication for PKP was CAP. PKP had high rates of delivery and procedural success. At long-term follow-up, there was a high rate of TLR, mainly due to ISR and ST. These results are consistent with previously reported data in these clinical settings.

Post resuscitation electrocardiogram for coronary angiography indication after out-of-hospital cardiac arrest.

BACKGROUND: Coronary angiography is the standard of care after Out-of-Hospital Cardiac Arrest (OHCA), but its benefit for patients without persistent ST-segment elevation (STE) remains controversial. METHODS: All patients admitted for coronary angiography after a resuscitated OHCA were consecutively included in this prospective study. Three patient groups were defined according to post-resuscitation ECG: STE or new left bundle branch block (LBBB) (group 1); other ST/T repolarization disorders (group 2) and no repolarisation disorders (group 3). The proportion and predictive factors of an acute coronary lesion, defined by acute coronary occlusion or thrombotic lesion or lesion associated with flow impairment, were evaluated according to different groups as well as thirty-day mortality. RESULTS: Among 129 consecutive patients: 62 (48.1%), 30 (23.3%) and 30 (23.3%) patients were included in groups 1, 2 and 3 respectively. An acute coronary lesion was observed in 43% (n = 55) of patients, mainly in group 1 (n = 44, 70.9%). Initial coronary TIMI 0/1 flow was more frequently observed in group 1 than in group 2 (n = 25, 40.3% vs n = 1, 3.3%) and never in group 3. Chest pain and STE or new LBBB were independently associated with an acute coronary lesion (adj. OR = 7.14 [1.85-25.00]; p = 0.004 and adj. OR = 11.10 [3.70-33.33]; p < 0.001 respectively). In absence of any repolarization disorders, acute coronary lesion or occlusion were excluded with negative predictive values of 93.3% and 100% respectively. The one-month survival rate was 38.8% and was better in patients among the group 1 compared to those from the 2 other groups (n = 28, 45.2% vs n = 21, 35%, respectively; p = 0.014). CONCLUSION: Considering the high negative predictive value of post-resuscitation ECG to exclude acute coronary lesion and occlusion after OHCA, a delayed coronary angiography appears a reliable alternative for patients without repolarization disorders.

Is hypertriglyceridemia atherogenic?

ASCVD reduction is based on LDL reduction, especially by statins. Highly elevated TG could be harmful, especially because of the risk of pancreatitis. Elevation of TG is mainly due to metabolic disorders and diabetes, alcohol intake and overweight. Genetic factors have been clearly identified in the most severe cases. TG have been generally considered as bystanders for cardiovascular diseases (CVD). Both biological and basic research provide strong data suggesting that TG-rich lipoproteins could be involved in the pathophysiology of CVD. Recent epidemiological and genetics studies strongly corroborate the causal role of TG in CVD. This paves the way for new approaches in the management of patients both for primary and secondary prevention.

An hs-TNT Second Peak Associated with High CRP at Day 2 Appears as Potential Biomarkers of Micro-Vascular Occlusion on Magnetic Resonance Imaging after Reperfused ST-Segment Elevation Myocardial Infarction.

INTRODUCTION: Micro-vascular occlusion (MVO) in a myocardial infarction (MI) is associated with an increased risk of heart failure and mortality. Hs-T-troponin has a double peak kinetic after MI. The aim was to determine if this kinetic was correlated to MVO evaluated by cardiac magnetic resonance imaging (MRI) after MI. METHODS: This is a monocentric retrospective study. Inclusion criteria were hospitalization for MI, Thrombolysis In Myocardial Infarction flow 0 at coronary angiography, reperfusion within 12 h from the onset of chest pain, cardiac MRI within the first month, and a 5-days' biological follow-up with at least hs-T-Troponin and C-reactive protein (CRP). Statistics were performed using the R software. RESULTS: Ninety-eight patients were included. Fifty-three patients (54.1%) had MVO at MRI. The existence of MVO was associated with a trend of more kissing procedure during primary percutaneous coronary intervention (p = 0.06), a significantly more frequent second peak of troponin (p = 0.048), a significantly higher CRP level (p < 0.0001) and a longer time to balloon (p = 0.01). The association of CRP level above 40 mg/L at day 2 and the observation of a second peak of troponin were associated to 95% of MVO in ST-segment elevation MI patients. By contrast, in the absence of these 2 criteria, MVO was absent in 78% of the cases. This score was associated with a higher rate of hospitalisation at 2 years. CONCLUSION: A biological score integrating hs-TNT second peak and CRP might help to predict MVO and predict outcomes after reperfused MI in our population.

Safety of Percutaneous Coronary Intervention Without P2Y12 Inhibitor Pretreatment From a Cohort of Unselected Patients.

OBJECTIVES: Recent studies have challenged systematic pretreatment with a P2Y12 inhibitor before percutaneous coronary intervention (PCI) in elective and non-ST segment elevation myocardial infarction (NSTEMI) patients. The aim of this study was to assess outcomes after performing PCI immediately after coronary angiography with an exclusive "on-the-table" P2Y12 inhibitor loading dose, by evaluating ischemic and bleeding complications in unselected patients. METHODS: Consecutive patients admitted for elective PCI or NSTEMI were included in this two-center, prospective, observational study, and received a P2Y12 inhibitor after coronary angiography when PCI was decided. The primary composite endpoint was first occurrence of cardiovascular death, myocardial infarction, stroke, urgent revascularization, or use of bail-out glycoprotein IIb/IIIa inhibitors at 30 days after PCI. Stent thrombosis and bleeding criteria (Bleeding Academic Research Consortium [BARC]) were evaluated. RESULTS: Among 299 included patients, a total of 188 were admitted for elective PCI and 111 for NSTEMI. The incidence of the primary endpoint was 8.5% (95% confidence interval [CI], 5.7-12.4). No definite stent thrombosis occurred. Three independent predictive factors were associated with the primary endpoint: NSTEMI setting (odds ratio [OR], 5.61; 95% CI, 1.75-17.98), thrombotic coronary lesion (OR, 4.26; 95% CI, 1.45-12.54), and longer procedure duration (OR, 1.06; 95% CI, 1.03-1.09). Clinically relevant bleedings (BARC 2, 3, or 5) occurred in 5.4% of patients. CONCLUSIONS: In an unselected population admitted for elective PCI or NSTEMI in real-world clinical practice, administration of a P2Y12 inhibitor only after coronary angiography is associated with a low rate of ischemic and bleeding events at 30 days.

Area at risk can be assessed by iodine-123-meta-iodobenzylguanidine single-photon emission computed tomography after myocardial infarction: a prospective study.

BACKGROUND: Myocardial salvage is an important surrogate endpoint to estimate the impact of treatments in patients with ST-segment elevation myocardial infarction (STEMI). AIM: The aim of this study was to evaluate the correlation between cardiac sympathetic denervation area assessed by single-photon emission computed tomography (SPECT) using iodine-123-meta-iodobenzylguanidine (I-MIBG) and myocardial area at risk (AAR) assessed by cardiac magnetic resonance (CMR) (gold standard). PATIENTS AND METHODS: A total of 35 postprimary reperfusion STEMI patients were enrolled prospectively to undergo SPECT using I-MIBG (evaluates cardiac sympathetic denervation) and thallium-201 (evaluates myocardial necrosis), and to undergo CMR imaging using T2-weighted spin-echo turbo inversion recovery for AAR and postgadolinium T1-weighted phase sensitive inversion recovery for scar assessment. RESULTS: I-MIBG imaging showed a wider denervated area (51.1±16.0% of left ventricular area) in comparison with the necrosis area on thallium-201 imaging (16.1±14.4% of left ventricular area, P<0.0001). CMR and SPECT provided similar evaluation of the transmural necrosis (P=0.10) with a good correlation (R=0.86, P<0.0001). AAR on CMR was not different compared with the denervated area (P=0.23) and was adequately correlated (R=0.56, P=0.0002). Myocardial salvage evaluated by SPECT imaging (mismatch denervated but viable myocardium) was significantly higher than by CMR (P=0.02). CONCLUSION: In patients with STEMI, I-MIBG SPECT, assessing cardiac sympathetic denervation may precisely evaluate the AAR, providing an alternative to CMR for AAR assessment.

Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial.

BACKGROUND: Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence has suggested that aortic valvuloplasty may cause complications and that high success rates may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation of the aortic valve and using new-generation balloon-expandable transcatheter heart valves is associated with a better net clinical benefit than TAVI performed with predilatation. METHODS/DESIGN: The transcatheter aortic valve implantation without prior balloon dilatation (DIRECTAVI) trial is a randomized controlled open label trial that includes 240 patients randomized to TAVI performed with prior balloon valvuloplasty (control arm) or direct implantation of the valve (test arm). All patients with an indication for TAVI will be included excepting those requiring transapical access. The trial tests the hypothesis that the strategy of direct implantation of the new-generation balloon-expandable SAPIEN 3 valve is noninferior to current medical practice using predilatation of the valve. The primary endpoint assessing efficacy and safety of the procedure consists of immediate procedural success and secondary endpoints include complications at 30-day follow-up (VARC-2 criteria). A subgroup analysis evaluates neurological ischemic events with cerebral MRI imaging (25 patients in each strategy group) performed before and between 1 and 3 days after the procedure. DISCUSSION: This prospective randomized study is designed to assess the efficacy and safety of TAVI performed without prior dilatation of the aortic valve using new-generation balloon-expandable transcatheter heart valves. We aim to provide robust evidence of the advantages of this strategy to allow the interventional cardiologist to use it in everyday practice. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02729519 . Registered on 15 July 2016.

COLIN trial: Value of colchicine in the treatment of patients with acute myocardial infarction and inflammatory response.

BACKGROUND: Inflammation is involved during acute myocardial infarction, and could be an interesting target to prevent ischaemia-reperfusion injuries. Colchicine, known for its pleiotropic anti-inflammatory effects, could decrease systemic inflammation in this context. AIMS: To evaluate the impact of colchicine on inflammation in patients admitted for ST-segment elevation myocardial infarction (STEMI). METHODS: All patients admitted for STEMI with one of the main coronary arteries occluded, and successfully treated with percutaneous coronary intervention, were included consecutively. Patients were randomized to receive either 1mg colchicine once daily for 1 month plus optimal medical treatment or optimal medical treatment only. C-reactive protein (CRP) was assessed at admission and daily until hospital discharge. The primary endpoint was CRP peak value during the index hospitalization. RESULTS: Forty-four patients were included: 23 were treated with colchicine; 21 received conventional treatment only. At baseline, both groups were well balanced regarding age, sex, risk factors, thrombolysis in myocardial infarction flow and reperfusion delay. The culprit artery was more often the left anterior descending artery in the colchicine group (P=0.07), reflecting a more severe group. There was no significant difference in mean CRP peak value between the colchicine and control groups (29.03mg/L vs 21.86mg/L, respectively; P=0.36), even after adjustment for type of culprit artery (26.99 vs 24.99mg/L, respectively; P=0.79). CONCLUSION: In our study, the effect of colchicine on inflammation in the context of STEMI could not be demonstrated. Further larger studies may clarify the impact of colchicine in acute myocardial infarction.

Feasibility and Safety of Transcatheter Aortic Valve Implantation Performed Without Intensive Care Unit Admission.

Admission to the intensive care unit (ICU) is a standard of care after transcatheter aortic valve implantation (TAVI); however, the improvement of the procedure and the need to minimize the unnecessary use of medical resources call into question this strategy. We evaluated prospectively 177 consecutive patients who underwent TAVI. Low-risk patients, admitted to conventional cardiology units, had stable clinical state, transfemoral access, no right bundle branch block, permanent pacing with a self-expandable valve, and no complication occurring during the procedure. High-risk patients included all the others transferred to ICU. In-hospital events were the primary end point (Valve Academic Research Consortium 2 criteria). The mean age of patients was 83.5 ± 6.5 years, and the mean logistic EuroSCORE was 14.6 ± 9.7%. The balloon-expandable SAPIEN 3 valve was mainly used (n = 148; 83.6%), mostly with transfemoral access (n = 167; 94.4%). Among the 61 patients (34.5%) included in the low-risk group, only 1 (1.6%) had a minor complication (negative predictive value 98.4%, 95% confidence interval [CI] 0.91 to 0.99). Conversely, 31 patients (26.7%) from the high-risk group had clinical events (positive predictive value 26.7%, 95% CI 0.19 to 0.35), mainly conductive disorders requiring pacemaker (n = 26; 14.7%). In multivariate analysis, right bundle branch block (odds ratio [OR] 14.1, 95% CI 3.5 to 56.3), use of the self-expandable valve without a pacemaker (OR 5.5, 95% CI 2 to 16.3), vitamin K antagonist treatment (OR 3.8, 95% CI 1.1 to 12.6), and female gender (OR 2.6, 95% CI 1.003 to 6.9) were preprocedural predictive factors of adverse events. In conclusion, our results suggested that TAVI can be performed safely without ICU admission in selected patients. This strategy may optimize efficiency and cost-effectiveness of procedures.

Kinetics of high-sensitivity cardiac troponin T and I differ in patients with ST-segment elevation myocardial infarction treated by primary coronary intervention.

PURPOSE: Cardiac biomarkers including troponins are the cornerstone of the biological definition of acute myocardial infarction. New high-sensitivity cardiac assays determining troponin T (hs-cTnT) as well as I ((hs-cTnI) from Abbott and s-cTnI from Siemens) raise concerns because of their unclear kinetics following the peak. AIMS: This study aims to compare kinetics of creatine kinases, hs-cTnT, hs-cTnI and s-cTnI in patients with ST-segment elevation myocardial infarction (STEMI) treated by percutaneous coronary intervention. METHODS: We prospectively studied 106 consecutive patients admitted in our institution for STEMI and treated by percutaneous coronary intervention. We evaluated for all the patients simultaneously kinetics of creatine kinases, hs-cTnT (Roche) and two different cTnIs (hs-cTnI from Abbott and s-cTnI from Siemens). Modelling of kinetics was realized using mixed effects with cubic splines. RESULTS: Kinetics of markers showed a first peak at 10.7h (8.0-12.0) for creatine kinases, 11.8h (10.4-13.3) for hs-cTnT (Roche); 11.8h (10.7-11.8) for hs-cTnI from Abbott and 10.2h (8.7-11.6) for s-cTnI from Siemens, respectively. This peak was followed by a nearly log linear decrease for hs-cTnI/s-cTnI and creatine kinases in contrast to hs-cTnT, which appeared with a biphasic shape curve marked by a second peak at 76.9h (69.5-82.8). The analysis of the decrease in percentage of the peak value at 77h showed that hs-cTnT follows a twice lower decrease than other markers. CONCLUSION: Kinetics of hs-cTnT, hs-cTnI and s-cTnI differ significantly with a linear decrease regarding both cTnI assays contrasting with a biphasic shape curve for hs-cTnT. This is of importance for clinical management of patients in routine settings especially in follow-up after STEMI including the suspicion of reinfarction.

SPECT Myocardial Perfusion Reserve in Patients with Multivessel Coronary Disease: Correlation with Angiographic Findings and Invasive Fractional Flow Reserve Measurements.

UNLABELLED: Quantification of myocardial perfusion reserve (MPR) is an emerging topic in nuclear cardiology with an expected diagnostic and prognostic incremental value, especially for patients with severe coronary artery disease. The advent of new dedicated solid-state cameras has opened new perspectives for perfusion quantitation in SPECT. We appraised the feasibility of perfusion reserve estimation using a cadmium zinc telluride camera in a cohort of multivessel patients and its pertinence with respect to angiographic data. METHODS: Twenty-three patients with known multivessel coronary artery disease were prospectively enrolled. Dynamic SPECT acquisitions using (99m)Tc-tetrofosmin at rest and after vasodilator stress were performed using a dedicated cadmium zinc telluride camera. Reconstructed frames were automatically segmented to extract the vascular input function and the myocardial uptake curve. One-compartment kinetic modeling was used to estimate global and regional uptake values, and then myocardial blood flow was derived using the Renkin-Crone equation. Global and regional MPR was assessed using flow difference (stress - rest) and flow ratio (stress/rest). All patients underwent control coronary angiography within 4 wk, which served as the reference for MPR index assessment. Relevant angiographic findings included maximal stenosis and (for a subgroup of 26 vessels) invasive measurement of fractional flow reserve (FFR). A stenosis was considered obstructive if greater than 50% and an FFR abnormal if lower than 0.8. RESULTS: Global MPR correlated well with number of obstructed vessels (P < 0.001). After multivariate analysis, both regional flow ratio and flow difference were significantly associated with maximal stenosis (P < 0.001) and FFR (P < 0.001). Regional MPR indices were significantly different in obstructed and nonobstructed vessels (P < 0.001) and in vessels with normal and abnormal FFR (P < 0.001). With a cutoff of 2, the sensitivity, specificity, and accuracy of regional flow ratio were, respectively, 80%, 85%, and 81% for the detection of obstructed vessels and 89%, 82%, and 85% for the detection of abnormal FFR. CONCLUSION: Scintigraphic estimations of global and regional MPR in multivessel patients using a cadmium zinc telluride camera appear to correlate well with invasive angiographic findings, including maximal stenosis and FFR measurements.

Vascular Complications and Bleeding After Transfemoral Transcatheter Aortic Valve Implantation Performed Through Open Surgical Access.

Major vascular complications (VC) remain frequent after transcatheter aortic valve implantation (TAVI) and may be associated with unfavorable clinical outcomes. The objective of this study was to evaluate the rate of VC after transfemoral TAVI performed using an exclusive open surgical access strategy. From 2010 to 2014, we included in a monocentric registry all consecutive patients who underwent transfemoral TAVI. The procedures were performed with 16Fr to 20Fr sheath systems. VC were evaluated within 30 days and classified as major or minor according to the Valve Academic Research Consortium 2 definition. The study included 396 patients, 218 were women (55%), median age was 85 years (81 to 88), and the median logistic Euroscore was 15.2% (11 to 23). The balloon-expandable SAPIEN XT and the self-expandable Medtronic Core Valve prosthesis were used in 288 (72.7%) and 108 patients (27.3%), respectively. The total length of the procedure was 68 ± 15 minutes including 13 ± 5 minutes for the open surgical access. Major and minor VC were observed in 9 (2.3%) and 16 patients (4%), respectively, whereas life-threatening and major bleeding concerned 18 patients (4.6%). The median duration of hospitalization was 5 days (interquartile range 2 to 7), significantly higher in patients with VC (7 days [5 to 15], p <0.001). Mortality at 1-month and 1-year follow-up (n = 26, 6.6%; and n = 67, 17.2%, respectively) was not related to major or minor VC (p = 0.6). In multivariable analysis, only diabetes (odds ratio 2.5, 95% confidence interval 1.1 to 6.1, p = 0.034) and chronic kidney failure (odds ratio 3.0, 95% confidence interval 1.0 to 9.0, p = 0.046) were predictive of VC, whereas body mass index, gender, Euroscore, and lower limb arteriopathy were not. In conclusion, minimal rate of VC and bleeding can be obtained after transfemoral TAVI performed using an exclusive surgical strategy, with a particular advantage observed in high-risk bleeding patients.

Collagen plug-based vascular closure devices do not decrease vascular and bleeding complications occurring after balloon aortic valvuloplasty.

BACKGROUND: The benefits of vascular closure devices (VCDs) in the prevention of vascular complications after femoral intervention remain controversial. AIM: To evaluate the efficiency of collagen plug-based VCDs in the prevention of femoral access complications after balloon aortic valvuloplasty. METHODS: We conducted a prospective analysis of consecutive patients who underwent balloon aortic valvuloplasty by femoral retrograde technique in our centre between 2009 and 2012. Group 1 included 75 patients in whom femoral puncture haemostasis was obtained with the use of an 8F collagen plug-based VCD (Angio-Seal™; Saint-Jude Medical, Inc.); group 2 included 105 patients who had manual or mechanical groin compression (FemoStop™; RADI Medical Systems, Inc.). We did not use heparin during the procedure. We collected data on major in-hospital adverse events, major bleeding (Bleeding Academic Research Consortium classification≥3) and vascular access complications. RESULTS: We included 180 patients with severe and symptomatic aortic stenosis. Indications for valvuloplasty were mainly bridge to transcatheter aortic valve implantation or palliative therapy (72%). The groups were similar in terms of median age, lower limb artery disease and body mass index. Vascular and bleeding complications occurred in 11.1% of patients and were not decreased with the use of VCDs (relative risk 2.60, 95% confidence interval 1.10-3.09; P=0.05). These findings were consistent across all prespecified subgroups. Duration of hospital stay was not reduced by VCDs. CONCLUSIONS: Based on the results of this study, performed with small-size sheaths and without heparin, collagen plug-based VCDs increase femoral access complications following aortic valvuloplasty. Systematic use of VCDs in elderly patients, with probable advanced limb atherosclerosis, is questionable.

Kinetics of high-sensitivity cardiac troponin T or troponin I compared to creatine kinase in patients with revascularized acute myocardial infarction.

BACKGROUND: Cardiac biomarkers are the cornerstone of the biological definition of acute myocardial infarction (AMI). The key role of troponins in diagnosis of AMI is well established. Moreover, kinetics of troponin I (cTnI) and creatine kinase (CK) after AMI are correlated to the prognosis. New technical assessment like high-sensitivity cardiac troponin T (hs-cTnT) raises concerns because of its unclear kinetic following the peak. This study aims to compare kinetics of cTnI and hs-cTnT to CK in patients with large AMI successfully treated by percutaneous coronary intervention (PCI). METHODS: We prospectively studied 62 patients with anterior AMI successfully reperfused with primary angioplasty. We evaluated two consecutive groups: the first one regularly assessed by both CK and cTnI methods and the second group by CK and hs-cTnT. Modeling of kinetics was realized using mixed effects with cubic splines. RESULTS: Kinetics of markers showed a peak at 7.9 h for CK, at 10.9 h (6.9-12.75) for cTnI and at 12 h for hs-cTnT. This peak was followed by a nearly log linear decrease for cTnI and CK by contrast to hs-cTnT which appeared with a biphasic shape curve marked by a second peak at 82 h. There was no significant difference between the decrease of cTnI and CK (p=0.63). CK fell by 79.5% (76.1-99.9) vs. cTnI by 86.8% (76.6-92.7). In the hs-cTnT group there was a significant difference in the decrease by 26.5% (9-42.9) when compared with CK that fell by 79.5% (64.3-90.7). CONCLUSIONS: Kinetic of hs-cTnT and not cTnI differs from CK. The role of hs-cTnT in prognosis has to be investigated.

Decrease of vascular and bleeding complications after balloon aortic valvuloplasty performed without heparin.

OBJECTIVES: To determine whether vascular and bleeding complications may be reduced with balloon aortic valvuloplasty (BAV) performed without heparin. BACKGROUND: Vascular and bleeding complications are currently the main adverse events occurring after BAV. METHODS: This registry included 162 consecutive patients with severe aortic stenosis who underwent BAV by femoral approach in our center between 2008 and 2012. Eighty-five patients had unfractionated heparin (UH) 50 IU/kg bolus IV during the procedure, whereas 77 patients did not have heparin. Our primary combined endpoint included severe vascular or bleeding complications (BARC score ≥3), severe ischemic events (acute limb ischemia or systemic embolism) or death at 1-month follow-up. RESULTS: The primary composite endpoint was achieved in 25 patients overall (15.4%) and was significantly lower in the heparin-free group (10.3% vs 20.0%; P=.03). Vascular, bleeding, or ischemic events were dramatically lower in the heparin-free group (6.5%) compared with the heparin group (18.8%; P=.01). UH use was associated with an increased risk of vascular and bleeding complications (relative risk, 2.92; 95% confidence interval, 1.35-7.94), but not with a decreased risk of ischemic events (relative risk, 1.81, 95% confidence interval, 0.34-9.61). After adjustment for patient and procedure characteristics, including the sheath size, heparin use was the only significant predictor of the primary endpoint (adjusted odds ratio, 2.94; 95% confidence interval, 1.75-14.74). CONCLUSION: BAV performed without heparin is associated with a reduction of severe vascular events or death without increased ischemic risk. This marked difference is difficult to explain by confounding factors, but should be confirmed in a randomized controlled trial.

Intracoronary administration of darbepoetin-alpha at onset of reperfusion in acute myocardial infarction: results of the randomized Intra-Co-EpoMI trial.

BACKGROUND: Several trials investigating erythropoietin as a novel cytoprotective agent in myocardial infarction (MI) failed to translate promising preclinical results into the clinical setting. These trials could have missed crucial events occurring in the first few minutes of reperfusion. Our study differs by earlier intracoronary administration of a longer-acting erythropoietin analogue at the onset of reperfusion. AIM: To evaluate the ability of intracoronary administration of darbepoetin-alpha (DA) at the very onset of the reperfusion, to decrease infarct size (IS). METHODS: We randomly assigned 56 patients with acute ST-segment elevation MI to receive an intracoronary bolus of DA 150 µg (DA group) or normal saline (control group) at the onset of reflow obtained by primary percutaneous coronary intervention (PCI). IS and area at risk (AAR) were evaluated by biomarkers, cardiac magnetic resonance (CMR) and validated angiographical scores. RESULTS: There was no difference between groups regarding duration of ischemia, Thrombolysis in Myocardial Infarction flow grade at admission and after PCI, AAR size and extent of the collateral circulation, which are the main determinants of IS. The release of creatine kinase was not significantly different between the two groups even when adjusted to AAR size. Between 3-7 days and at 3 months, the area of hyperenhancement on CMR expressed as a percentage of the left ventricular myocardium was not significantly reduced in the DA group even when adjusted to AAR size. CONCLUSION: Early intracoronary administration of a longer-acting erythropoietin analogue in patients with acute MI at the time of reperfusion does not significantly reduce IS.

Could heart rate play a role in pericardial inflammation?

UNLABELLED: PURPOSE AND MEDICAL HYPOTHESIS: Rest is usually recommended in acute pericarditis, as it could help to lower heart rate (HR) and contribute to limit "mechanical inflammation". Whether HR on admission could be correlated and perhaps participate to inflammation has not been reported. METHODS: Between March 2007 and February 2010, we conducted a retrospective study on all patients admitted to our center for acute pericarditis. Diagnosis criteria included two of the following ones: typical chest pain, friction rub, pericardial effusion on cardiac echography, or typical electrocardiogram (ECG) findings. Primary endpoint was biology: CRP on admission, on days 1, 2, 3, and especially peak. RESULTS: We included 73 patients. Median age was 38 years (interquartiles 28-51) and median hospitalization duration was 2.0 days (1.5-3.0). Median heart rate was 88.0 beats per minute (bpm) on admission (interquartiles 76.0-100.0) and 72.0 on discharge (65.0-80.0). Heart rate on admission was significantly correlated with CRP peak (p<0.001), independently of temperature on admission, hospitalization duration and age. Recurrences occurred within 1 month in 32% of patients. Heart rate on hospital discharge was correlated with recurrence, independently of age. CONCLUSION: In acute pericarditis, heart rate on admission is independently correlated with CRP levels and heart rate on discharge seems to be independently correlated to recurrence. This could suggest a link between heart rate and pericardial inflammation.