News Article | November 14, 2016
BOSTON, MA--(Marketwired - Nov 14, 2016) - InspireMD, Inc. ( : NSPR) ("InspireMD" or the "Company"), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced that it has received regulatory approval to commercialize the CGuard™ Embolic Prevention System for the treatment of carotid artery disease in Russia. The approval was granted by Russia's Federal Service for Surveillance in Healthcare (Roszdravnadzor). According to a presentation titled "Carotid Stenting and Surgery in 2016 in Russia" at Novosibirsk Research Institute of Circulation Pathology, the Management Board Report of Russian Society of Angiology and Vascular Surgeons reported that Russia, among all European countries, has the highest rate of mortality from cerebrovascular disease. The presentation[i] concluded that carotid stenting in Russia has been increased among carotid reconstructions. "The approval of CGuard™ in Russia is another important commercial milestone for the Company's continued growth," said James Barry, PhD, Chief Executive Officer of InspireMD. "With this approval coming on the heels of our positive 12-month follow up data from PARADIGM-101, we are pleased to bring this technology to another important market in the global marketplace." As previously announced, Prof. Piotr Musialek, MD, DPhil, FESC, from the Jagiellonian University Department of Cardiac & Vascular Diseases, in Krakow, Poland, reported 12-month follow up data from PARADIGM-101 at the Transcatheter Cardiovascular Therapeutics 2016 scientific symposium. PARADIGM-101 is an investigator-led clinical study evaluating the use of CGuard™ EPS in 101 consecutive patients with carotid artery stenosis. A link to the data results and presentation can be accessed: http://www.inspiremd.com/en/wp-content/uploads/TCT_16.-PARADIGM-12M_-Piotr-Musialek.pdf PARADIGM is an investigator-initiated Prospective evaluation of All-comer peRcutaneous cArotiD revascularization In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuard™ Mesh-covered embolic prevention stent system. Dr. Musialek previously presented data from the first cohort in the PARADIGM study, which comprised 71 CGuard™ EPS procedures in unselected all-comer patients, at EuroPCR 2015. The early outcome data in the target cohort of 101 patients were presented as a Late-Breaking Clinical Trial at EuroPCR 2016 and were simultaneously published in EuroIntervention. These data showed a 100% success rate for the CGuard Embolic Prevention System during the placement procedure. Importantly, there were no procedure-related complications during CGuard™ EPS placement and at 30 days post procedure. Similarly, there were no major adverse cardiac or neurological events, as determined by operator-independent neurologist and non-invasive cardiologist evaluation. The new data presented at TCT are important because they confirm safety and durability of the CGuard™ EPS innovative treatment over 12 months. The CGuard™ EPS is designed to prevent peri-procedural and late embolization by trapping potential emboli against the arterial wall while maintaining excellent perfusion to the external carotid artery. MicroNet™ is a bio-stable mesh woven from a single strand of 20 micron Polyethylene Terephthalate (PET). CGuard™ EPS is CE Marked and not approved for sale in the U.S. by the U.S. Food and Drug Administration at this time. Carotid stenosis is a narrowing of the carotid arteries, the major arteries that supply blood and oxygen to the brain. This narrowing results from a buildup of plaque inside the blood vessel and reduces blood flow to the brain. The presence of plaque in the blood vessel can also cause the development of blood clots, which may also reduce blood flow to the brain. In some cases, plaque may rupture or dislodge from the vessel wall and block smaller downstream arteries. Patients with carotid stenosis have an increased risk of stroke as a result of cerebral embolism and decreased blood flow to the brain. Patients with symptomatic carotid stenosis are typically treated by placement of a stent inside the blood vessel in order to re-open the carotid artery and improve blood flow to the brain. InspireMD's CGuard™ EPS uses the company's patented MicroNet™ technology to provide the revascularization benefits of a stent with a mesh "safety net" that secures the plaque against the blood vessel's arterial wall and thereby prevents plaque and other debris from flowing through the stent's scaffold. InspireMD seeks to utilize its proprietary MicroNet™ technology to make its products the industry standard for embolic protection and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events. InspireMD intends to pursue applications of this MicroNet technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD's common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS. This press release contains "forward-looking statements." Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov.The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. [i] Starodubtsev V, Karpenko A, Ignatenko P. Carotid stenting and surgery in 2016 in Russia. Novosibirsk Research Institute of Circulation Pathology. 2016. http://acst-2.org/onewebmedia/10.Starodubtsev.pdf. Accessed November, 13, 2016.
News Article | February 28, 2017
NEW YORK, NY, February 28, 2017 Yoshiaki Omura has been included in Marquis Who's Who. As in all Marquis Who's Who biographical volumes, individuals profiled are selected on the basis of current reference value. Factors such as position, noteworthy accomplishments, visibility, and prominence in a field are all taken into account during the selection process.With almost five decades of invaluable contributions to his field, Dr. Omura is renowned for his excellence as a medical researcher and educator. He discovered how to detect cancer from an electro-cardiogram and his work is strongly accepted worldwide. Dr. Omura will be a keynote speaker at the World Congress in Baltimore, MD, on February 20-22, 2017. Dr. Omura was also a keynote speaker on February 8, 2017 at European Parliament in Brussels, Belgium on non-invasive early diagnosis of cancer.Best recognized as the creator of the US patented non-invasive, early diagnostic method of cancer & cardiovascular diseases "Bi-Digital O-Ring Test", Dr. Omura parlays his expertise into roles at New York Medical College, where he is an adjunct professor of family and community medicine. Until 2 years ago, he has been affiliated with the Heart Disease Research Foundation, where he has been the director of medical research since 1972, the College of Physicians and Surgeons at Columbia University, where he has been a member of the alumni council since 1986, and the Ukrainian National Medical University, where he has been a professor for more than 10 years in the department of non-orthodox medicine since 1993.Dr. Omura earned an associate degree from Electrical Engineering Dept. of Nihon University, a Bachelor of Science in applied physics from Waseda University, and an MD from Yokohama City University. Upon graduation, Dr. Omura started as a rotating intern at Tokyo University Hospital and subsequently held the same role at Norwalk Hospital in Connecticut. In 1960 he joined Columbia University as a research fellow in cardiovascular surgery, which is the same year he began postgraduate studies in experimental physics. From 1961 until 1965, he worked as a resident physician in oncological surgery at Francis Delafield Hospital, then main cancer institute of Columbia University and towards the end of that role, he earned a Doctor of Science degree from the College of Physicians and Surgeons at Columbia University in Pharmaco-electrophysiology of single cardiac cell in vivo & in vitro. Dr. Omura has also worked as a visiting professor at the University of Paris, important research position at INSERM (National Institute of Health of France), visiting professor of Unviersity of Padua, Italy, visiting professor of Yonsei University in Seoul, Korea, visiting professor of Showa University of Tokyo, visiting professor of Chinese Medical School, consultant with the New York Pain Center, and vice chair for the American Board of Forensic Medicine.A diplomate through the International College of Acupuncture and Electro-Therapeutics, the American Academy of Pain Management and the American Academy of Experts in Traumatic Stress, Dr. Omura has contributed his extensive knowledge to a variety of creative works. He is the author of 9 books and has also served on the editorial board of the Scandinavian Journal of Acupuncture and Electrotherapy since 1987, as editor-in-chief of the Acupuncture & Electro-Therapeutics Research, International Journal since 1974, and Functional Neurology of Italy from 1988 until 2002. In order to remain abreast of changes in the field, he affiliates himself with the New York Cardiology Society, the American College of Angiology, the American Association of Integrative Medicine, and the life fellow of Royal Society of Medicine of England, as well as many others.A shining example of excellence in his field, Dr. Omura has achieved much throughout his long-standing career, including obtaining seven U.S. and seven Japanese patents in the medical field. In recognition of his efforts, he was named Acupuncture Scientist of the Year through the International Congress of Chinese Medicine in 1989 and earned the World First Qi Gong Scientist of the Year Award through the same organization a year later. Additionally, he has had the honor of being named to Who's Who in American Education, Who's Who in Science and Engineering and Who's Who in Medicine and Healthcare. Among the top 100 scientists by International Biographical Institute of Oxford, he was selected.To learn more about Dr. Omura, visit https://www.linkedin.com/in/yoshiaki-omura-m-d-sc-d-42436047 About Marquis Who's Who :Since 1899, when A. N. Marquis printed the First Edition of Who's Who in America , Marquis Who's Who has chronicled the lives of the most accomplished individuals and innovators from every significant field of endeavor, including politics, business, medicine, law, education, art, religion and entertainment. Today, Who's Who in America remains an essential biographical source for thousands of researchers, journalists, librarians and executive search firms around the world. Marquis publications may be visited at the official Marquis Who's Who website at www.marquiswhoswho.com
Cosmi B.,S. Orsola Malpighi University Hospital |
Legnani C.,S. Orsola Malpighi University Hospital |
Pengo V.,University of Padua |
Ghirarduzzi A.,Angiology |
And 5 more authors.
Thrombosis and Haemostasis | Year: 2013
It was our aim to assess whether factor V Leiden (FVL) and G20210A prothrombin (FII) mutation are associated with the presence of residual vein obstruction (RVO) after a standard course of anticoagulation for a first episode of idiopathic proximal deep-vein thrombosis (DVT) of the lower limbs, with or without symptomatic pulmonary embolism (PE). Patients were enrolled in two prospective multicentre studies: PROLONG and PROLONG II. RVO was detected by compression ultrasonography according to the method of Prandoni on the day of anticoagulation withdrawal. Patients were also screened for FVL and FII mutation. The presence of FVL and/or FII mutation was determined in 872/963 (90.5%) patients, in 753 of whom RVO was assessed. FVL was significantly less frequent among subjects with isolated PE (7/176:4%) than among patients with either DVT and PE (15/133:11.3%; p=0.0018) or isolated DVT (89/563:15.8%; p<0.0001), confirming the FVL paradox. The rate of FII mutation was similar among patients with isolated PE (11/176:6.2%) and patients with either DVT and PE (12/133:9%) or isolated DVT (52/563:9.2%). FVL and FII mutation were not significantly associated with RVO at the multivariate analysis in all patients, although data suggest that FVL and FII mutation may have a differential effect on RVO in the subgroups of patients with DVT and DVT plus PE patients. Male sex and isolated DVT were significantly associated with RVO in all patients. In conclusion, male sex and isolated DVT are associated with RVO, while FVL and FII mutations are not significantly associated with RVO in this study. © Schattauer 2013.
News Article | November 22, 2016
NEW YORK, NY, November 22, 2016-- Dr. Henry Pan has been included in Marquis Who's Who. As in all Marquis Who's Who biographical volumes, individuals profiled are selected on the basis of current reference value. Factors such as position, noteworthy accomplishments, visibility, and prominence in a field are all taken into account during the selection process.Dr. Pan arrived in the United States in 1969 upon completion of a Bachelor of Science degree in genetics from McGill University in Montreal, Canada, to pursue graduate studies at the University of Hawaii with the late Professor Louis Casarett, a world renowned inhalation toxicologist. Dr. Pan graduated with a Master of Science in toxicology and later a Ph.D. in molecular pharmacology from the University of Hawaii. While at the University, he was both a research and teaching assistant. Following his graduate degrees, Dr. Pan entered medical school and graduated in 1979 from the University of Hong Kong, School of Medicine. Upon graduation, Dr. Pan entered the field as a medical officer at Queen Mary Hospital from 1979 to 1981, and was a tenured assistant professor of medicine and clinical pharmacology at the University of Hong Kong from 1981 to 1985.Dr. Pan returned to the United States in 1983 as a fellow in clinical pharmacology and a visiting professor of medicine at Stanford University, School of Medicine. This marked the beginning of an impressive three decades of field work in research, administrative, directorial, and chief operating roles in executive positions. Ten years' worth of healthcare and medicinal knowledge and extensive research skills developed both in the classroom and the hospital opened the doors to a myriad of opportunities. Dr. Pan has been the vice president of clinical research and development at the Bristol Myers Squibb Company; the executive vice president of drug development and medical affairs at the DuPont Merck Pharmaceutical Company; the president and CEO of MDS Pharmaceutical Services; chief executive officer of Vennworks RTP; the executive vice president and chief medical officer of Neurocrine Biosciences Inc.; and the executive vice president and chief scientific and medical officer of Prometheus Laboratories Inc., among other positions. His current positions include the chief executive officer of Renascions Inc. and Renascions Biopharma Inc., and the chief executive of Pan Consulting Associates LLC, where he provides consulting services to North American, European, and Asian biopharmaceutical companies.Dr. Pan has been inducted as a fellow in multiple prestigious organizations: the American College of Cardiology, the American College of Clinical Pharmacology, the American Heart Association, the American Society of Angiology, the Institute of Biological and Clinical Investigation, the Academy of Medicine of New Jersey, and the Faculty of Pharmaceutical Medicine of the Royal College of Physicians in the UK. He has served on the board of 15 companies and was the chairman of the biopharmaceutical division of the Society of Chinese Bioscientists in America, one of the largest minority science organizations in the United States.For his contributions to the medical field, Dr. Pan has been included in the 47th through 50th, 52nd through 57th, 59th through 61st, 63rd, and the 67th through 70th editions of Who's Who in America; the 2nd through 6th editions of Who's Who in Medicine and Healthcare; the 1st through 6th editions of Who's Who in Science and Engineering; the 23rd through 28th editions of Who's Who in the East; the 16th through 25th editions of Who's Who in the World; and the 4th edition of Who's Who of Emerging Leaders in America.About Marquis Who's Who :Since 1899, when A. N. Marquis printed the First Edition of Who's Who in America , Marquis Who's Who has chronicled the lives of the most accomplished individuals and innovators from every significant field of endeavor, including politics, business, medicine, law, education, art, religion and entertainment. Today, Who's Who in America remains an essential biographical source for thousands of researchers, journalists, librarians and executive search firms around the world. Marquis now publishes many Who's Who titles, including Who's Who in America , Who's Who in the World , Who's Who in American Law , Who's Who in Medicine and Healthcare , Who's Who in Science and Engineering , and Who's Who in Asia . Marquis publications may be visited at the official Marquis Who's Who website at www.marquiswhoswho.com
News Article | December 20, 2016
World's first annuloplasty system for mitral and tricuspid repair incorporating proprietary PolyCor™ and MyoLast™ technologies. NEWTOWN, Pennsylvania, Dec. 20, 2016 /PRNewswire/ -- Micro Interventional Devices, Inc.™ (MID), announced today that it has successfully completed the first clinical implantation of its proprietary MIA™ technology for minimally invasive mitral and tricuspid repair. The MIA implant is made from PolyCor™ anchors and MyoLast™ implantable elastomer. The MIA device reduces annular dimensions, and thus regurgitation, following deployment in the patient's native annulus. The annular reduction is achieved without sutures or other intervention. This implantation represents the first clinical enrollment in the company's STTAR clinical study. STTAR (the Study of Transcatheter Tricuspid Annular Repair) is a multi center safety and performance study being conducted in Europe. MIA was implanted during a minimally invasive tricuspid repair procedure concomitant with mitral valve repair. The procedure was performed by Professor Kestutis Rucinskas, MD, Chief of Cardiac Surgery, and Professor Audrius Aidietis, MD, Chief of Cardiology and Angiology, at the Vilnius University Hospital Santariskiu Clinic in Vilnius, Lithuania. There were no intraoperative complications or adverse events observed or reported. Post-procedural patient recovery has been uneventful. "On Tuesday, December 6th we successfully deployed nine MIA Implants in our first patient's tricuspid annulus during a minimally invasive tricuspid repair procedure," Willard Hennemann, PhD, MID's Chief Science Officer, commented. "A significant reduction in valve area was observed post procedure. We look forward to enrolling additional patients in the STTAR study and to following these patients to assess the long term effect of MIA on valve insufficiency." There are approximately 1.1 million patients in the United States who are not currently being treated for mitral and tricuspid regurgitation because most candidates are not eligible for surgery, today's standard of care.1 The major advantage of MIA is its potential to address this large, underserved patient population by enabling percutaneous repair procedures. "Utilizing MIA in the STTAR study is the first step in demonstrating the safety and performance of a catheter-based mitral and tricuspid repair system," said Michael Whitman, MID's Founder, President & CEO. "This data point is encouraging. We are ever more confident of achieving our goal of a truly percutaneous mitral and tricuspid repair. It is our objective to make MIA safe, simple and secure." MID is the world leader in compliant fixation technology addressing unmet needs in structural heart disease. Sources: (1) Internal Estimates Based off of References on File
News Article | March 1, 2017
World's first annuloplasty system for mitral and tricuspid repair incorporating proprietary PolyCor™ and MyoLast™ technologies. NEWTOWN, Pennsylvania, March 1, 2017 /PRNewswire/ -- Micro Interventional Devices, Inc.™ (MID), announced today that it has successfully completed the second clinical case with its proprietary MIA™ technology for percutaneous mitral and tricuspid repair. This is the second successful clinical procedure and the second patient enrolled in the company's STTAR clinical study. STTAR, the Study of Transcatheter Tricuspid Annular Repair, is a multi center safety and performance study being conducted in Europe. The patient was a 60-year-old man with severe mitral and moderate tricuspid regurgitation. Eight MIA implants were deployed into the patient's tricuspid annulus in a 270-degree partial ring pattern concomitant with mitral valve repair. The MIA deployments took 14 minutes to complete and resulted in a 48% acute reduction in annular area. The annular reduction is achieved without sutures or other intervention. The first two procedures were performed by Professor Kestutis Rucinskas, MD, Chief of Cardiac Surgery, and Professor Audrius Aidietis, MD, Chief of Cardiology and Angiology, at the Vilnius University Hospital Santariskiu Clinic in Vilnius, Lithuania. As with the first case, there were no intraoperative complications or adverse events observed or reported and post-procedural patient recovery has been uneventful. The first patient, treated on December 6th, 2016, has now been followed to 30 days with no observed or reported adverse events. The reduction in annular area observed at hospital discharge has been maintained at 30-day follow-up. "On Friday, February 3rd, we successfully deployed eight MIA implants into the patient's tricuspid annulus. It was impressive that the clinicians only took 14 minutes to deploy the technology," Willard Hennemann, PhD, MID's Chief Science Officer, commented. "Prior to deployment of the MIA implants the intraoperative saline injection leak test demonstrated a lack of leaflet coaptation. After deployment of the MIA implants the saline injection leak test revealed full leaflet coaptation and a competent valve. The acute 48% reduction in valve area observed was comparable to that achieved with the current surgical standard of care. This reduction was maintained at hospital discharge." The MIA implant is made from the proprietary PolyCorTM anchors bonded to the proprietary, self-tensioning, implantable elastomer called MyoLastTM. This is the world's first low mass polymeric implant designed specifically to comply with normal physiological valvular function. The MIA implant is specifically engineered to plicate and comply with cardiac soft-tissue once deployed. "Enrolling patients in the first arm of the STTAR Study has demonstrated the feasibility of the procedure and the capability of the MIA implant to significantly reduce annular dimensions," said Michael Whitman, MID's Founder, President & CEO. "These initial results are extremely encouraging and support our thesis that MIA is safe, simple, and secure. We look forward to continued enrollment and further favorable results." There are approximately 2.3 million patients worldwide who are not currently being treated for mitral and tricuspid regurgitation because most candidates are not eligible for surgery, today's standard of care.1 The major advantage of MIA is its potential to address this large, underserved patient population by enabling percutaneous valve repair procedures. MID is the world leader in percutaneous transcatheter compliant fixation technology addressing unmet needs in structural heart disease. Sources: 1 Internal Estimates Based off of References on File
Ouedraogo N.,University of Angers |
Chanut M.,Angiology |
Aubourg M.,Cardiovascular Rehabilitation |
Le Hello C.,University of Caen Lower Normandy |
And 4 more authors.
Journal of Vascular Surgery | Year: 2013
Background: The Walking Impairment Questionnaire (WIQ) is used to estimate walking impairment in patients with peripheral artery disease; however, it faces frequent errors when self-completed and is complex to score. We aimed to validate an alternative, easily scored four-item tool, the Walking Estimated-Limitation Calculated by History (WELCH) questionnaire. Methods: The WIQ and WELCH were prospectively tested in five centers. We studied 434 patients, among which 298 had a treadmill test (3.2 km/h; 10% slope) to determine their maximum walking time (MWT), and 30 were seen twice during the study period. Results: After self-completion, we found at least one error in 177 WIQ (40.8%; 95% confidence interval [CI], 36.3%-45.5%) vs 56 WELCH (12.9%; 95% CI, 10.1%-16.4%) questionnaires (P <.0001). When scoring only questionnaires without missing or duplicate answers, 267 WIQ (61.5%; 95% CI, 56.9%-66.0%) vs 393 WELCH (90.6%; 95% CI, 87.4%-93.0%) questionnaires could be scored (P <.001). The median MWT was 233 seconds (interquartile range, 133-654 seconds) for the 298 patients who had a treadmill test. When the 296 patients who had both questionnaire scores available were studied, no difference was found between the Pearson r coefficient of correlation of the WIQ (r = 0.615) and the WELCH (r = 0.653) with MWT (P =.211). In the 30 patients who completed the WELCH twice, correlation was r = 0.839 (P <.001) between the two scores in 22 nonrevascularized patients, and the area under the receiver-operating characteristic curve was 0.830 ± 0.105 (P <.01) to discriminate the eight revascularized from the 22 nonrevascularized patients. Conclusions: The WELCH questionnaire is a simple tool to estimate walking limitation in patients with suspected peripheral artery disease. It is easily scored by mental calculation. It may help to standardize the estimation of walking limitation in routine clinical practice.© 2013 by the Society for Vascular Surgery.
Cosmi B.,University of Bologna |
Legnani C.,University of Bologna |
Tosetto A.,S Bortolo Hospital |
Pengo V.,University of Padua |
And 7 more authors.
Blood | Year: 2010
The PROLONG randomized trial showed that a normal D-dimer (D-d) 1 month after anticoagulation suspension for unprovoked venous thromboembolism (VTE) was associated with a low risk of late recurrences (4.4% patient years). However, it is unknown whether D-d changes subsequently. The aim of this prospective multicenter study was to assess D-d time course and its relation with late recurrences in patients with normal D-d 1 month after anticoagulation suspension for a first episode of unprovoked VTE. D-d was measured with a qualitative method (Clearview Simplify D-dimer; Inverness Medical Professional Diagnostics). Patients with a normal D-d 1 month after stopping anticoagulation repeated D-d testing every 2 months for 1 year. D-d was normal in 68% (243/355) of patients 1 month after anticoagulation suspension. Patients in whom D-d became abnormal at the third month and remained abnormal afterward had a higher risk of recurrence (7/31; 27% patient years; 95% confidence interval [CI]: 12-48) than patients in whom D-d remained normal at the third month and afterward (4/149; 2.9% patient years; 95% CI: 1-7; adjusted hazard ratio: 7.9; 95% CI: 2.1-30; P = .002). Repeated D-d testing after anticoagulation suspension for a first episode of unprovoked VTE could help tailor the duration of treatment. This trial is registered at http://clinicaltrials.gov as NCT00266045. © 2010 by The American Society of Hematology.
Cuneo A.,Angiology |
Oeckinghaus R.,Angiology |
Herz | Year: 2011
Introduction: Leisure sport activity (LSA) is gaining in importance among middle-aged and senior men in the German population. There is a consensus that regular aerobic exercise at moderate intensities and increased physical fitness are associated with a reduced risk of fatal and nonfatal acute cardiac events (ACE) in middle-aged individuals. However, vigorous exercise (VE) can acutely and transiently increase the risk of an ACE in susceptible individuals. There is an ongoing discussion as to whether preparticipation screening may prevent such events. This case study characterizes patients participating in LSA who had not been involved in preparticipation screening prior to their ACE. Methods: In the period between June 2003 and July 2009, all consecutive patients with an ACE presenting at the catheter laboratory were retrospectively screened for VE that had occurred during LSA. All 13 men with previously unknown coronary artery disease (CAD) had exercised regularly. All patients underwent coronary angiography. This study characterized clinical parameters, duration of LSA, coronary diagnostic procedure, as well as therapeutic intervention. Results: In seven patients, cardiovascular (CV) risk factors comprised arterial hypertension in seven, hyperlipidemia in seven, smoking or former smoking in two, family history of CV disease in four, and previous peripheral atherosclerotic disease in two. The culprit lesion was identified in seven patients in the left anterior descending artery, in four in the right coronary artery, and in two in the circumflex artery. The mean left ventricular ejection fraction was 65% (45-84). The mean complexity of the lesions using the syntax score was 17 (2-36). PCI was performed in 12 patients, while one patient was transferred for coronary artery bypass grafts. All patients survived their ACE. Conclusion: This case study supports the data indicating that ACE in men with previously unknown CAD is not uncommon during LSA. This patient cohort provides data on a group of patients who might benefit from preparticipation screening. © 2011 Urban & Vogel.
Guthoff M.,Angiology |
Schmid-Horch B.,Institute of Clinical and Experimental Transfusion Medicine |
Weisel K.C.,Oncology and Immunology |
Haring H.-U.,Angiology |
And 2 more authors.
Transplant Immunology | Year: 2012
Background: Sensitization to human leukocyte antigen (HLA) prolongs waiting list time and reduces allograft survival in solid organ transplantation. Current strategies for pretransplant desensitization are based on B-cell depletion and extracorporeal treatment. The proteasome inhibitor bortezomib allows direct targeting of the antibody-producing plasma cell and has been used in antibody-mediated rejection (AMR) and recipient desensitization with varying results. Here, we report the effect of bortezomib preconditioning on HLA antibody titers and specificity in highly sensitized patients awaiting renal allograft transplantation. Patients and methods: Two highly sensitized patients awaiting third kidney transplantation were given one cycle of bortezomib (1.3. mg/m 2, days 1, 4, 8, 11), as part of recipient desensitization. Time-course and levels of anti-HLA antibodies, as well as specificity to previous transplant antigens were monitored by luminex technology. In addition, measles and tetanus toxoid immunoglobulin G (IgG) was measured. Results: Following bortezomib, overall changes in IgG levels were small and no sustained reduction in anti-HLA class I or II antibody levels was observed over more than 100. days of follow-up to both, donor specific and non-donor specific antigens. Moreover, anti-measles and -tetanus toxoid IgG levels remained unchanged. Conclusions: Bortezomib preconditioning alone does not result in sustained reduction of HLA antibody levels or alter protective immunity in sensitized patients. This supports the notion, that bortezomib requires activation of plasma cells, as in AMR, to effectively reduce HLA antibody production. Hence, in a pretransplant setting, combination strategies may be required to derive benefit from proteasome inhibition. © 2012 Elsevier B.V.