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MassDevice.com +5 | The top 5 medtech stories for April 13, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Toshiba partners with UCI to study potential brain damage in HS football players Toshiba said yesterday it is partnering with the University of California, Irvine to study possible brain damage incurred in high school football ...
Source: Mass Device - April 13, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Medtronic Freestyle aortic bioprosthesis: a potential option for haemodialysis patients
CONCLUSIONS Aortic bioprostheses are a good option for haemodialysis patients requiring AVR, offering acceptable mid-term survival. The Medtronic Freestyle aortic bioprostheses could allow the implantation of larger bioprostheses inferring consequently lower mean gradients, with a potentially higher resistance to calcification and sclerosis in haemodialysis patients.
Source: Interactive CardioVascular and Thoracic Surgery - March 21, 2016 Category: Cardiovascular & Thoracic Surgery Authors: Hegazy, Y. Y., Rayan, A., Sodian, R., Hassanein, W., Ennker, J. Tags: Basic research vascular ADULT CARDIAC Source Type: research

Sex-Specific Differences at Presentation and Outcomes Among Patients Undergoing Transcatheter Aortic Valve Replacement: A Cohort Study.
Conclusion: Despite a higher incidence of vascular and bleeding complications, women having TAVR had lower mortality than men at 1 year. Thus, sex-specific risk in TAVR is the opposite of that in SAVR, for which female sex has been shown to be independently associated with an adverse prognosis. Primary Funding Source: Edwards Lifesciences. PMID: 26903039 [PubMed - as supplied by publisher]
Source: Annals of Internal Medicine - February 23, 2016 Category: Internal Medicine Authors: Kodali S, Williams MR, Doshi D, Hahn RT, Humphries KH, Nkomo VT, Cohen DJ, Douglas PS, Mack M, Xu K, Svensson L, Thourani VH, Tuzcu EM, Weissman NJ, Leon M, Kirtane AJ Tags: Ann Intern Med Source Type: research

Artificial aortic valve dysfunction due to pannus and thrombus - different methods of cardiac surgical management.
CONCLUSIONS: Precise and modern diagnostic methods facilitated selection of the treatment method. However, the intraoperative view also seems to be crucial in individualizing the surgical approach. PMID: 26702274 [PubMed]
Source: Polish Journal of Cardio-Thoracic Surgery - January 20, 2016 Category: Cardiovascular & Thoracic Surgery Tags: Kardiochir Torakochirurgia Pol Source Type: research

Medtech approvals: FDA releases August 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015: Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 70 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 28 Total On Hold: 29 Summary of PMA Supplements Under Review Total Under Review: 569 Total Active: 422 Total On Hold: 147 Summary of All PMA Submissions Originals: 5 Supplements: 90 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 70 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 229.0 FDA Time: 130...
Source: Mass Device - October 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news

Contemporary Outcomes of Coronary Artery Bypass Grafting Among Patients With Insulin-Treated and Non–Insulin-Treated Diabetes
Conclusions Patients with diabetes undergoing CABG have substantially increased risk of major adverse events. Patients with ITDM represent an especially high-risk group.
Source: The Annals of Thoracic Surgery - August 25, 2015 Category: Cardiovascular & Thoracic Surgery Source Type: research

Contemporary Outcomes of Coronary Artery Bypass Grafting Among Patients With Insulin-Treated and Non-Insulin-Treated Diabetes.
CONCLUSIONS: Patients with diabetes undergoing CABG have substantially increased risk of major adverse events. Patients with ITDM represent an especially high-risk group. PMID: 26319487 [PubMed - as supplied by publisher]
Source: The Annals of Thoracic Surgery - August 25, 2015 Category: Cardiovascular & Thoracic Surgery Authors: Li Z, Amsterdam EA, Young JN, Hoegh H, Armstrong EJ Tags: Ann Thorac Surg Source Type: research

Clinical Value of Ankle-Brachial Index in Asymptomatic Aortic Stenosis Patients.
CONCLUSION: Among asymptomatic AS patients, 35.8% had an abnormal ABI and this was related to previous diabetes. These patients walked less in the 6MWT but did not have a worse prognosis at follow up. PMID: 26204678 [PubMed - in process]
Source: Journal of Heart Valve Disease - July 25, 2015 Category: Cardiology Tags: J Heart Valve Dis Source Type: research

Bypass surgery an “uncommon” cause of memory loss, cognitive decline
Coronary artery bypass surgery (CABG) offers a new lease on life for thousands of people each year whose hearts aren’t getting the blood they need to work properly. But it has also been blamed for “brain fog,” a loss of memory and thinking skills that follows the procedure in some people. Such brain problems are often called cognitive impairment. The operation itself may not be to blame, according to a review in today’s Annals of Internal Medicine. For the review, a team of researchers—mostly from the U. S. Department of Veteran’s Affairs—synthesized data from 17 clinical trials and four w...
Source: New Harvard Health Information - July 22, 2015 Category: Consumer Health News Authors: Howard LeWine, M.D. Tags: Heart Health bypass surgery Coronary artery bypass surgery memory loss Source Type: news

Eating chocolate may slightly lower your risk of stroke
ConclusionThis study used a large prospective cohort of English residents to estimate the risk chocolate poses to cardiovascular death and disease. In addition, they systematically combed the research literature for other similar studies, combining their results with that of other researchers. By comparing the highest chocolate consumers with chocolate abstainers, they found that chocolate was linked to a lower risk of stroke and cardiovascular disease. The risk for coronary heart disease was not statistically significant. Results from the meta-analysis of eight additional studies showed higher chocolate consumption was li...
Source: NHS News Feed - June 16, 2015 Category: Consumer Health News Tags: Food/diet Heart/lungs Neurology Source Type: news

221 * prognostic impact and late evolution of untreated moderate functional tricuspid regurgitation in patients undergoing aortic valve replacement
Conclusion: Preoperative untreated TR 2/4+ improves or remains stable in the majority of the cases. However, occurrence of TR ≥ 3+ of 8% at last follow-up is not reassuring, suggesting the need for a better characterisation of patients with preoperative TR 2/4+ undergoing AVR, in order to identify subjects at risk for TR progression.
Source: Interactive CardioVascular and Thoracic Surgery - September 23, 2014 Category: Cardiovascular & Thoracic Surgery Authors: Taramasso, M., De Bonis, M., Pozzoli, A., Schiavi, D., Latib, A., Buzzatti, N., Canna, G. L., Alfieri, O. Tags: The tricuspid: A continuing problem Source Type: research

256 * mitral valve repair has better long-term outcomes compared with mitral valve replacement in elderly patients with mitral regurgitation
Conclusion: MVP is a safe option and improves long-term survival and freedom from MACE, even in the elderly with mitral regurgitation.
Source: Interactive CardioVascular and Thoracic Surgery - September 23, 2014 Category: Cardiovascular & Thoracic Surgery Authors: Okamura, H., Yamaguchi, A., Kimura, N., Itoh, S., Yuri, K., Matsumoto, H., Adachi, H. Tags: Long-term results of mitral valve surgery Source Type: research

017 * aortic valve replacement through an anterior right mini-thoracotomy with central aortic cannulation is safe
Conclusion: MIAVR via an anterior right mini-thoracotomy with central cannulation results in similar perioperative mortality and stroke rates as compared to standard sternotomy. In addition, the MIAVR technique resulted in earlier extubation, fewer wound infections, reduced intraoperative transfusions, and shorter ICU and hospital stays. As compared to standard sternotomy AVR, our technique of MIAVR with preferential central cannulation appears safe.
Source: Interactive CardioVascular and Thoracic Surgery - September 23, 2014 Category: Cardiovascular & Thoracic Surgery Authors: Hui, D., Bowdish, M., Cleveland, J., Ranjan, R., Sinha, R., Baker, C. J., Cunningham, M. J., Starnes, V. A. Tags: Small incisions and sutureless valves: A perfect marriage Source Type: research

337 * direct aortic implantation of a self-expanding transcatheter aortic valve leads to favourable outcomes
Conclusion: DA TAVI with the CoreValve System led to favourable early outcomes in patients with prohibitive iliofemoral access.
Source: Interactive CardioVascular and Thoracic Surgery - September 23, 2014 Category: Cardiovascular & Thoracic Surgery Authors: Bruschi, G., Moat, N. Tags: Late Breakers I Source Type: research

Stroke in Patients With Aortic Stenosis: The Simvastatin and Ezetimibe in Aortic Stenosis Study Clinical Sciences
Conclusions— In patients with aortic stenosis not prescribed oral anticoagulation, atrial fibrillation, AVR with concomitant coronary artery bypass grafting, and CHA2DS2-VASc score were the major predictors of stroke. Incident stroke was strongly associated with mortality. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00092677.
Source: Stroke - June 23, 2014 Category: Neurology Authors: Greve, A. M., Dalsgaard, M., Bang, C. N., Egstrup, K., Ray, S., Boman, K., Rossebo, A. B., Gohlke-Baerwolf, C., Devereux, R. B., Kober, L., Wachtell, K. Tags: Thrombosis risk factors, CV surgery: valvular disease, Acute Cerebral Infarction Clinical Sciences Source Type: research