Rotterdam, Netherlands
Rotterdam, Netherlands

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PARIS & EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--Revealing a potential new role for fractional flow reserve (FFR) in cath labs, investigators from the Erasmus Medical Center unveiled early results from the independent, physician-sponsored FFR-Search Registry, which revealed an association between post-percutaneous coronary intervention (PCI) FFR measurements with the ACIST Navvus® Rapid Exchange FFR MicroCatheter and clinical outcomes. The investigators found that microcatheter-based FFR was feasible in various clinical settings, including acute coronary syndromes and ST elevation myocardial infarction, and almost half of patients had an FFR lower than 0.90 after PCI. As anticipated, these early results did not have a meaningful impact on 30-day clinical outcomes; patients will now be followed out to the two-year primary endpoint to shed more definitive light on the value of post-PCI FFR in clinical practice. These early findings were presented during a late-breaking trial session at EuroPCR 2017 in Paris, France. The registry enrolled over 1,000 consecutive patients with stable angina or acute coronary syndromes that had undergone percutaneous coronary intervention at Erasmus Medical Center in Rotterdam to determine the association of post-PCI FFR values on clinical outcomes, as measured at 30-days, one-year, two-years and five-years follow-up. In an attempt to replicate real world clinical practice, the protocol precluded operators from additional optimization techniques after the initial stent placement. Using the ACIST Navvus Rapid Exchange FFR MicroCatheter — an ultra-thin monorail microcatheter with fiber-optic technology — the average post-PCI FFR value was 0.96 in a resting state and 0.91 under hyperemic conditions in the 959 patients who were able to undergo FFR measurement. Utilizing the microcatheter technology allowed the investigators the unique benefit of delivering the pressure sensor diagnostic directly over any 0.014” workhorse guidewire post-PCI and only added approximately 5 minutes to the overall procedural time. Interestingly, 22 percent of patients whose lesions were stented still had at least one post-PCI FFR measurement less than or equal to 0.85. The primary clinical endpoint is MACE defined as all-cause mortality, myocardial infarction (MI) and any revascularization. The initial 30-day data found that FFR measurements greater than 0.9 resulted in a MACE rate of 1.5 percent, while measurements less than 0.9 resulted in a MACE rate of 2.3 percent (p=ns). Furthermore, as the FFR measurements decreased in patients, the MACE rates numerically increased. While the patient cohorts with FFR measurements below 0.90 were underpowered to show statistical differences between groups, FFR measurements in the 0.86-0.90, 0.81-0.85 and less than or equal to 0.80 ranges resulted in MACE rates of 2.0 percent, 2.6 percent, and 2.8 percent, respectively. “As FFR becomes more and more the standard to determine treatment approaches in patients with coronary artery disease, we are excited to see that this technology is safe, fast and easy to apply — as well as may be used to optimize longer-term outcomes after interventional procedures,” said FFR-Search investigator Dr. Nicolas M. Van Mieghem, MD, PhD, FESC, co-principal investigator and Director of Interventional Cardiology at Thoraxcenter, Erasmus Medical Center in Rotterdam, Netherlands. “The preliminary data from FFR-Search has the potential to significantly expand this technology’s role in the cath lab in the future, which is why we’re eager to see the important results of the primary endpoint at two years.” In 60 of the patients having an FFR value equal to or less than 0.85, an intravascular high definition ultrasound analysis was performed to identify potential causes for the low post procedural FFR measurement. Stent under-expansion was the most frequently identified cause for low FFR, found in 84 percent of the cases, followed by focal lesions distal to the stent (52 percent), focal lesions proximal to the stent (43 percent) and stent malapposition (22 percent). “Based on these results, we look forward to continuing to build the evidence supporting this new role of FFR,” said FFR-Search co-investigator and presenter Dr. Roberto Diletti, MD, Interventional Cardiology at Thoraxcenter, Erasmus Medical Center in Rotterdam, Netherlands. “We are eager to see how the outcomes will unfold at one, two and five years, and how we may be able to best optimize these findings through further intervention after the post-treatment FFR measurement.” Unlike traditional pressure wires, the ACIST RXi® Rapid Exchange FFR System and Navvus® Rapid Exchange FFR MicroCatheter, allows physicians to use their 0.014” guidewire of choice throughout the procedure, addressing challenges of pressure wires, including, accessibility in challenging anatomies, maintaining wire position, pressure‐measurement drift and ease of obtaining post‐intervention FFR. “Given that our differentiated microcatheter technology allows physicians the ability to perform rapid FFR measurements before, during and after intervention, all while maintaining their guidewire position, we feel that we are uniquely suited to address this new role of FFR compared to other FFR measurement modalities, including pressure wire-based FFR,” said Tom Morizio, President and CEO, ACIST Medical Systems, Inc. “We look forward to partnering with physicians to develop this new approach and are optimistic about the possibility of our technology playing a new role in improving outcomes.” About FFR FFR measurement is a technique used in cardiology to determine the effect of narrowing, or stenosis, in the coronary arteries on blood flow. It allows for a more effective assessment of coronary lesions than when only using angiography, the gold-standard imaging technique. By identifying which stenoses are causing ischemia by significantly restricting the blood flow to the heart muscle and causing the patient’s symptoms, FFR can help avoid unnecessary stenting to reopen the blood vessels, leading to improved patient outcomes.1,2 About ACIST ACIST Medical Systems, Inc. is a pioneering interventional and diagnostic technology company with a portfolio of advanced products, including the world’s first Rapid Exchange FFR and High Definition IVUS systems. It is also a global market leader in advanced contrast imaging systems for cardiovascular angiography and radiology imaging. Through these products, ACIST is demonstrating its commitment to bringing unique and innovative technologies that simplify cardiovascular procedures and empower clinicians to treat patients with superior care. As part of the Bracco Group, ACIST benefits from the resources of a multinational conglomerate with broad expertise in cath lab technology and a dedication to continuous advancement. Headquartered in Eden Prairie, Minnesota, USA, ACIST has worldwide presence with over 300 direct employees and facilities in Silicon Valley, Heerlen, and Tokyo. To learn more about ACIST, visit www.acist.com. Bracco Group Bracco has headquarters in Milan, Italy, and was founded in 1927. It is active in the healthcare sector through Bracco Imaging (diagnostic imaging), ACIST Medical Systems and HLT (cardiology) and the Centro Diagnostico Italiano diagnostic clinic. It has around 3,400 employees and annual total consolidated revenues of over 1.3 billion Euro. Bracco operates in more than 100 countries worldwide. To learn more about Bracco Group, visit www.bracco.com. 1 Tonino PA et al. New Engl J Med 2009;360:213-24 2 De Bruyne B et al. New Engl J Med 2012;367:991-1001


Hickey G.L.,University of Manchester | Grant S.W.,University of Manchester | Cosgriff R.,University College London | Dimarakis I.,University of Manchester | And 4 more authors.
European Journal of Cardio-thoracic Surgery | Year: 2013

Clinical registries will have an increasingly important role to play in health-care, with a number already established in cardiac surgery. This review covers the fundamentals of establishing and managing clinical registries, including legal and ethical frameworks along with intellectual property attribution. Also discussed are important issues relating to the processing of data, data extraction and conducting analyses using registry data. © The Author 2013.Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.


Popma J.J.,Beth Israel Deaconess Medical Center | Adams D.H.,Mount Sinai Medical Center | Reardon M.J.,Houston Methodist Debakey Heart and Vascular Center | Yakubov S.J.,Riverside Methodist Hospital | And 17 more authors.
Journal of the American College of Cardiology | Year: 2014

Objectives This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery. Background Untreated severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy. Methods We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG). Results A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis). Conclusions TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).


Iqbal J.,Thoraxcenter | Iqbal J.,University of Sheffield | Vergouwe Y.,Erasmus Medical Center | Bourantas C.V.,Thoraxcenter | And 10 more authors.
JACC: Cardiovascular Interventions | Year: 2014

Objectives This study aimed to update the Logistic Clinical SYNTAX score to predict 3-year survival after percutaneous coronary intervention (PCI) and compare the performance with the SYNTAX score alone. Background The SYNTAX score is a well-established angiographic tool to predict long-term outcomes after PCI. The Logistic Clinical SYNTAX score, developed by combining clinical variables with the anatomic SYNTAX score, has been shown to perform better than the SYNTAX score alone in predicting 1-year outcomes after PCI. However, the ability of this score to predict long-term survival is unknown. Methods Patient-level data (N = 6,304, 399 deaths within 3 years) from 7 contemporary PCI trials were analyzed. We revised the overall risk and the predictor effects in the core model (SYNTAX score, age, creatinine clearance, and left ventricular ejection fraction) using Cox regression analysis to predict mortality at 3 years. We also updated the extended model by combining the core model with additional independent predictors of 3-year mortality (i.e., diabetes mellitus, peripheral vascular disease, and body mass index). Results The revised Logistic Clinical SYNTAX models showed better discriminative ability than the anatomic SYNTAX score for the prediction of 3-year mortality after PCI (c-index: SYNTAX score, 0.61; core model, 0.71; and extended model, 0.73 in a cross-validation procedure). The extended model in particular performed better in differentiating low- and intermediate-risk groups. Conclusions Risk scores combining clinical characteristics with the anatomic SYNTAX score substantially better predict 3-year mortality than the SYNTAX score alone and should be used for long-term risk stratification of patients undergoing PCI. © 2014 by The American College of Cardiology Foundation Published by Elsevier Inc.


Harold Laughlin M.,University of Missouri | Bowles D.K.,University of Missouri | Duncker D.J.,Thoraxcenter
American Journal of Physiology - Heart and Circulatory Physiology | Year: 2012

Exercise training (EX) induces increases in coronary transport capacity through adaptations in the coronary microcirculation including increased arteriolar diameters and/or densities and changes in the vasomotor reactivity of coronary resistance arteries. In large animals, EX increases capillary exchange capacity through angiogenesis of new capillaries at a rate matched to EX-induced cardiac hypertrophy so that capillary density remains normal. However, after EX coronary capillary exchange area is greater (i.e., capillary permeability surface area product is greater) at any given blood flow because of altered coronary vascular resistance and matching of exchange surface area and blood flow distribution. The improved coronary capillary blood flow distribution appears to be the result of structural changes in the coronary tree and alterations in vasoreactivity of coronary resistance arteries. EX also alters vasomotor reactivity of conduit coronary arteries in that after EX, a-adrenergic receptor responsiveness is blunted. Of interest, a- and (3-adrenergic tone appears to be maintained in the coronary microcirculation in the presence of lower circulating catecholamine levels because of increased receptor responsiveness to adrenergic stimulation. EX also alters other vasomotor control processes of coronary resistance vessels. For example, coronary arterioles exhibit increased myogenic tone after EX, likely because of a calcium-dependent PKC signaling-mediated alteration in voltage-gated calcium channel activity in response to stretch. Conversely, EX augments endothelium-dependent vasodilation throughout the coronary arteriolar network and in the conduit arteries in coronary artery disease (CAD). The enhanced endothelium-dependent dilation appears to result from increased nitric oxide bioavailability because of changes in nitric oxide synthase expression/ activity and decreased oxidant stress. EX also decreases extravascular compressive forces in the myocardium at rest and at comparable levels of exercise, mainly because of decreases in heart rate and duration of systole. EX does not stimulate growth of coronary collateral vessels in the normal heart. However, if exercise produces ischemia, which would be absent or minimal under resting conditions, there is evidence that collateral growth can be enhanced. While there is evidence that EX can decrease the progression of atherosclerotic lesions or even induce the regression of atherosclerotic lesions in humans, the evidence of this is not strong due to the fact that most prospective trials conducted to date have included other lifestyle changes and treatment strategies by necessity. The literature from large animal models of CAD also presents a cloudy picture concerning whether EX can induce the regression of or slow the progression of atherosclerotic lesions. Thus, while evidence from research using humans with CAD and animal models of CAD indicates that EX increases endothelium-dependent dilation throughout the coronary vascular tree, evidence that EX reverses or slows the progression of lesion development in CAD is not conclusive at this time. This suggests that the beneficial effects of EX in CAD may not be the result of direct effects on the coronary artery wall. If this suggestion is true, it is important to determine the mechanisms involved in these beneficial effects. © 2012 the American Physiological Society.


Schinkel A.F.L.,Erasmus University Rotterdam | Van Den Oord S.C.H.,Erasmus University Rotterdam | Van Der Steen A.F.W.,Thoraxcenter | Van Der Steen A.F.W.,Technical University of Delft | And 2 more authors.
European Heart Journal Cardiovascular Imaging | Year: 2014

AimsCarotid contrast-enhanced ultrasound (CEUS) was recently proposed for the evaluation of large-vessel vasculitides (LVV), particularly to assess vascularization within the vessel wall. The aim of this pilot study was to evaluate the potential of carotid colour Doppler ultrasound (CDUS) and CEUS in patients with LVV.Methods and resultsThis prospective study included seven patients (mean age 48 ± 14 years, all females) with established LVV (Takayasu arteritis or giant cell arteritis). All patients underwent CDUS and CEUS (14 carotid arteries). Intima-media thickness, lumen diameter, Doppler velocities, vessel wall thickening, and lesion thickness were assessed. CEUS was used to improve visualization of the lumen-to-vessel wall border, and to visualize carotid wall vascularization. Four (57%) patients [7 (50%) carotid arteries] exhibited lesions, and the average lesion thickness was 2.0 ± 0.5 mm. According to the Doppler peak systolic velocity, 5 (35%) carotid arteries had a <50% stenosis, 1 (7%) had a 50-70% stenosis, and 1 (7%) had a ≥70% stenosis. The contrast agent improved the image quality and the definition of the lumen-to-vascular wall border. Carotid wall vascularization was observed in 5 (71%) patients [9 (64%) carotid arteries]. Five (36%) carotid arteries had mild-to-moderate vascularization, and 4 (29%) had severe wall vascularization.ConclusionCarotid CDUS allows the assessment of anatomical features of LVV, including vessel wall thickening and degree of stenosis. Carotid CEUS improves the visualization of the lumen border, and allows dynamic assessment of carotid wall vascularization, which is a potential marker of disease activity in patients with LVV. © 2014 Published on behalf of the European Society of Cardiology. All rights reserved.


Magro M.,Thoraxcenter | Van Geuns R.-J.,Thoraxcenter
EuroIntervention | Year: 2010

The Tryton Side Branch Stent (Tryton Medical, Durham, NC, USA) is a dedicated bare metal stent developed to enhance the safety and efficacy of the two stent technique for the treatment of bifurcation lesions. The stenting technique, a "reverse culotte", secures the side branch (SB) with the placement of this dedicated stent in the proximal main vessel, across to the side branch while it facilitates the positioning of a conventional stent in the proximal to distal main vessel. The First-In-Man trial showed minimal SB late loss (0.17±0.35 mm) at six months while real world registry data reported target vessel revascularisation rates as low as 4% at the same time points and no stent thrombosis. The simplicity of the technique as well as the promising results have led to its widespread utilisation in Europe while in the US, a randomised trial is imminent and will serve for the device approval by the Food and Drug Administration. © Europa Edition 2010. All rights reserved.


Schinkel A.F.L.,Thoraxcenter | Boiten H.J.,Thoraxcenter | Van Der Sijde J.N.,Thoraxcenter | Ruitinga P.R.,Thoraxcenter | And 3 more authors.
Journal of Nuclear Cardiology | Year: 2012

Objective. The goal of this study was to evaluate the very long-term outcome after normal exercise 99mTc-sestamibi myocardial perfusion single-photon emission computed tomography (SPECT). Exercise 99mTc-sestamibi SPECT is widely used for risk stratification, but data on very long-term outcome after a normal test are scarce. Methods. A consecutive group of 233 patients (122 men, mean age 54 ± 12 years) with known or suspected coronary artery disease (CAD) underwent exercise 99mTc-sestamibi SPECT and had normal myocardial perfusion at exercise and at rest. Follow-up endpoints were allcause mortality, cardiac mortality, nonfatal myocardial infarction, and coronary revascularization. Predictors of outcome were identified by Cox proportional hazard regression models using clinical and exercise testing variables. Results. During amean follow-up of 15.5 ± 4.9 years, 41 (18%) patients died, of which 13were cardiac deaths. A total of 18 (8%) patients had a nonfatal myocardial infarction, and 47 (20%) had coronary revascularization. The annualized event rates for all-cause mortality, cardiac mortality, cardiac mortality/nonfatal infarction, and major adverse cardiac events were, respectively, 1.1%, 0.3%, 0.7%, and 1.8%. Multivariate analysis demonstrated that the variables age, male gender, diabetes, diastolic blood pressure at rest, rate pressure product at rest, peak exercise heart rate, and ST segment changes were independent predictors of major adverse cardiac events. Conclusion. Patients with suspected or known CAD and normal exercise 99mTc-sestamibi myocardial perfusion SPECT have a favorable 15-year prognosis. Follow-up should be closer in patients with known CAD, and/or having clinical and exercise parameters indicating higher risk status. (J Nucl Cardiol 2012;19:901-6.). © 2012 American Society of Nuclear Cardiology.


Nauta S.T.,Thoraxcenter | Deckers J.W.,Thoraxcenter | Van Domburg R.T.,Thoraxcenter | Martijn Akkerhuis K.,Thoraxcenter
Circulation | Year: 2012

Background-We aimed to study sex-related differences in temporal trends in short-and long-term mortality from 1985 to 2008 in patients hospitalized for acute myocardial infarction. Methods and Results-We included a total of 14 434 consecutive patients admitted to our intensive coronary care unit between 1985 and 2008 for myocardial infarction. A total of 4028 patients (28%) were women. Women were more likely to present with a higher risk profile and were equally likely to receive pharmacological and invasive reperfusion therapy compared with men. Women had a higher unadjusted mortality rate at 30 days (odds ratio, 1.3; 95% confidence interval, 1.1-1.5) and during 20 years (hazard ratio, 1.1; 95% confidence interval, 1.0-1.2) of follow-up. After adjustment for baseline characteristics, 30-day mortality was equal (adjusted odds ratio, 1.0; 95% confidence interval, 0.85-1.2) but the hazard for 20-year mortality was lower (adjusted hazard ratio, 0.77; 95% confidence interval, 0.66-0.90) in women compared to men. For 30-day mortality, there was no significant interaction between sex and age, diagnosis, or diabetes mellitus. Survival improved between 1985 and 2008. Temporal mortality reductions between 1985 and 2008 were at least as high in women as in men with myocardial infarction for both 30-day mortality and long-term mortality hazard. Conclusions-The fact that adjusted mortality rates for men and women treated for myocardial infarction in an intensive coronary care unit were similar and declined markedly over a 24-year period suggests that both sexes benefit from the evidence-based therapies that have been developed and implemented during this time period. © 2012 American Heart Association, Inc.


Genereux P.,Columbia University | Genereux P.,University of Montréal | Palmerini T.,University of Bologna | Caixeta A.,Federal University of São Paulo | And 8 more authors.
Journal of the American College of Cardiology | Year: 2012

Objectives: The purpose of this study was to quantify the extent and complexity of residual coronary stenoses following percutaneous coronary intervention (PCI) and to evaluate its impact on adverse ischemic outcomes. Background: Incomplete revascularization (IR) after PCI is common, and most studies have suggested that IR is associated with a worse prognosis compared with complete revascularization (CR). However, formal quantification of the extent and complexity of residual atherosclerosis after PCI has not been performed. Methods: The baseline Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) score (bSS) from 2,686 angiograms from patients with moderate- and high-risk acute coronary syndrome (ACS) undergoing PCI enrolled in the prospective ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial was determined. The SS after PCI was also assessed, generating the "residual" SS (rSS). Patients with rSS >0 were defined as having IR and were stratified by rSS tertiles, and their outcomes were compared to the CR group. Results: The bSS was 12.8 ± 6.7, and after PCI the rSS was 5.6 ± 2.2. Following PCI, 1,084 patients (40.4%) had rSS = 0 (CR), 523 (19.5%) had rSS >0 but ≤2, 578 (21.5%) had rSS >2 but ≤8, and 501 patients (18.7%) had rSS >8. Age, insulin-treated diabetes, hypertension, smoking, elevated biomarkers or ST-segment deviation, and lower ejection fraction were more frequent in patients with IR compared with CR. The 30-day and 1-year rates of ischemic events were significantly higher in the IR group compared with the CR group, especially those with high rSS. By multivariable analysis, rSS was a strong independent predictor of all ischemic outcomes at 1 year, including all-cause mortality (hazard ratio: 1.05, 95% confidence interval: 1.02 to 1.09, p = 0.006). Conclusions: The rSS is useful to quantify and risk-stratify the degree and complexity of residual stenosis after PCI. Specifically, rSS >8.0 after PCI in patients with moderate- and high-risk ACS is associated with a poor 30-day and 1-year prognosis. (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes; NCT00093158). © 2012 American College of Cardiology Foundation.

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