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REDWOOD CITY, Calif., May 9, 2017 /PRNewswire/ -- C2 Therapeutics marked Digestive Disease Week by releasing the results of clinical studies that help further validate the utility of the C2 CryoBalloon® Ablation System (CbAS) for ablation of Barrett's esophagus.i These include studies that suggest a shorter physician learning curve with CbAS than for radiofrequency ablation (RFA) therapy and less pain two days post-procedure than with RFA. Further studies demonstrate potential for CbAS in ablation of gastric antral vascular ectasia (GAVE) and esophageal squamous cell neoplasia (ESCN). The CbAS is similar to RFA in being deployed with an endoscopic catheter but uses extreme cold instead of heat to destroy diseased tissue in the esophagus. In a procedure known as cryoballoon ablation, nitrous oxide (N 0) cryogen is delivered through a handheld controller in combination with a self-sizing balloon catheter that is inserted into the working channel of a 3.7 mm therapeutic endoscope. The CbAS has been used in nearly 900 procedures to date. The synopses of the study results released for Digestive Disease Week are: Physician Learning Curve. Studies show that physicians must perform about 30 RFA procedures to overcome the effect of learning curve on treatment outcomes.1 This study aimed to determine the learning threshold for ablation of Barrett's esophagus with the CbAS. The researchers analyzed prospectively collected cryoablation procedure data from patients with neoplastic Barrett's esophagus treated at a single academic institution. They concluded that the learning curve effect for CbAS is reached at about 18 cases, after which efficiency plateaus. Patient Experience. Two studies in the Netherlands2 compared post-procedural pain in 79 Barrett's esophagus patients treated with RFA patients and 20 treated with focal cryoballoon ablation. In both studies, all visible Barrett's esophagus was treated, including circumferential treatment of the gastroesophageal junction. Pain was assessed immediately after the procedures and by telephone on Day 2. Patients were asked to apply pain scores from zero (no pain) to 10 (worst pain possible). Immediately after the procedure, 53% of cryoballoon ablation patients reported severe pain (score greater than 3), versus 24% of RFA patients. However, on Day 2, 46% of RFA patients reported severe pain, versus 18% of cryoballoon ablation patients. "This could suggest a shortened pain course after cryoballoon ablation compared with RFA," said the principal investigator Prof. Bas Weusten, Gastroenterology & Hepatology, St. Antonius Hospital, Nieuwegein, Netherlands. Treatment for ESCN. Esophageal squamous cell cancer arises from esophageal squamous cell neoplasia (ESCN) and is highly lethal. A multi-site study3 assessed the safety and efficacy of focal cryoballoon ablation for eradicating ESCN. Forty-two patients (98%) were successfully treated. Thirty-five of 40 patients (88%) had complete eradication of unstained lesions (USL) upon a single treatment session; five patients (12%) with persistent USL were successfully re-treated. Three developed superficial self-limited mucosal laceration upon balloon inflation; two of these were successfully treated three months later and one did not return. Dr. Gui-Qi Wang, Department of Endoscopy, Cancer Institute and Hospital Chinese Academy of Medical Sciences in Beijing, China stated, "Although longer-term follow-up data is pending, early results of our multicenter study suggest that focal cryoballoon ablation is safe, well-tolerated and highly effective in inducing complete endoscopic and histologic response." Treatment for GAVE. GAVE is an uncommon cause of upper gastrointestinal bleeding. Endoscopic management has been mainly thermoablative, but balloon cryoablation is emerging as an alternative. This multi-center study4 reviewed data from 10 patients with refractory GAVE who were treated with balloon cryotherapy. These were patients who continued to receive treatment for GAVE despite prior non-cryoballoon therapy. Each patient received one to four cryoballoon treatments (median two). Technical success was achieved in all patients. Follow-up endoscopy showed improvement in eight patients; one patient showed no improvement in the three months post-cryotherapy. No adverse events were reported. "Cryoballoon therapy is a feasible and safe modality that can be used to treat GAVE," reports Dr. Amrita Sethi, Division of Digestive and Liver Disease, Columbia University Medical Center, New York, NY. "Further studies are needed to evaluate long-term outcomes for this modality and to compare results to standard therapies." Swipe Cryoballoon Ablation Technique. Ablation devices for dysplastic Barrett's esophagus are effective, but none offer the attributes for widespread adoption because of length of procedure time and ease of use. Other factors include side effects and lack of predictability of ablation depth. This multi-center study5 evaluated the safety, feasibility and dose response of a novel swipe balloon catheter developed by C2 Therapeutics (to be marketed as the C2 CryoBalloon® 90 Ablation System), which delivers 3 cm of ablation in less than 60 seconds. The technique was tested in domestic swine and six human patients. The swipe technique delivered uniform and predictable ablation with mucosal and submucosal necrosis in animal and human esophagus. All the animals tolerated the ablations without difficulty and were able to eat and gain weight afterward. The human patients also tolerated the procedure without adverse events. Investigators concluded that because of its ease of use, the device merits further clinical study in treating dysplastic Barrett's esophagus. "These studies reinforce C2 Therapeutics' commitment to improving treatment for patients affected by Barrett's esophagus and other diseases of the gastrointestinal system," said Peter Garcia-Meza, President and CEO. "We continue to develop new design configurations to treat unmet needs in patients with diverse anatomy and disease characteristics. We sincerely appreciate the dedication and support of our collaborating study investigators and participating trial centers." Barrett's esophagus develops as a result of chronic injury from gastroesophageal reflux disease (GERD). Over time, the normal esophageal lining is replaced with abnormal cells (Barrett's esophagus), putting patients at greater risk of developing cancer of the esophagus. Founded in 2007 and headquartered in Redwood City, California, C2 Therapeutics developed the C2 CryoBalloon® Ablation System for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's esophagus with dysplasia. Acquired by PENTAX Medical – a division of HOYA Group – in January 2017, C2 Therapeutics continues to innovate and enhance its C2 CryoBalloon® Ablation System as a new standard for simplicity in the eradication of esophageal disease. For more information about C2 Therapeutics, please visit www.c2therapeutics.com. 1 George Kunnackal John, et al, Cryoballoon Ablation for Barrett's Esophagus: A Prospective Single Operator Learning Curve and Time-Efficiency Study, TU1170, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 2 Sanne N. van Munster, et al, Post-Procedure Pain Associated with Endoscopic Ablation Therapy of Barrett's Esophagus: Post-Hoc Comparison Between Radiofrequency Ablation and Cryoballoon Ablation, TU1186, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 3 Yan Ke, et al, Safety and Efficacy of Endoscopic Focal Cryoballoon Ablation for the Treatment of Esophageal Squamous Cell Intraepithelial Neoplasia, M01997, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 4 Anish Patel, et al, Endoscopic Management of Refractory Gastric Antral Vascular Ectasia (GAVE) with Cryoballoon Therapy: A Case Series, MO1986, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 5 Brian E. Louie, et al, Evaluation of a Novel Swipe Cryoballoon Ablation System in Bench, Porcine, and Human Esophagus, MO2010, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. i C2 CryoBalloon Focal Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's esophagus with dysplasia.


"This impressively low ischemic stroke rate favors left atrial appendage closure as an important therapy for patients ineligible for long-term oral anticoagulation," said Lucas V.A. Boersma, M.D., Ph.D., study principal investigator and electrophysiologist at St. Antonius Hospital, the Netherlands. "The results further validate the utility of the WATCHMAN device as an excellent alternative to anticoagulant therapy and its related bleeding risks for patients with non-valvular AF." In the study, patients were enrolled at 47 centers throughout Europe, Russia and the Middle East. More than 70 percent of the patients were deemed unsuitable for short or long-term anticoagulation at the time of WATCHMAN implantation. Transient ischemic attacks, ischemic stroke, vascular disease and a history of major bleeding were present in approximately half of the patients. "We are pleased to see that these 'real-world' results reinforce the positive outcomes observed in our clinical trial program, despite the registry patients being older and sicker than those enrolled in our previous trials," said Kenneth Stein, M.D., senior vice president and chief medical officer, Rhythm Management and Global Health Policy, Boston Scientific. Additional EWOLUTION data will be presented on May 18 at the annual EuroPCR Scientific Congress in Paris. The WATCHMAN device was CE-marked in 2005 to prevent thrombus embolization from the left atrial appendage and reduce the risk of life-threatening bleeding events in patients with non-valvular AF who are eligible for anticoagulation therapy, and in 2012 the CE Mark indication was expanded to include those who have a contraindication to anticoagulation therapy. In 2015, the device received FDA approval for patients with non-valvular AF who are at high stroke risk, suitable for warfarin and are seeking an alternative to long-term warfarin therapy. The Centers for Medicare and Medicaid Services (CMS) began covering percutaneous LAAC therapy for Medicare beneficiaries in February 2016 when patients meet the specific criteria outlined in the agency's final National Coverage Determination (NCD). For more information on the WATCHMAN device, visit www.watchman.com. *CHA2DS2 VASc and HAS-BLED scores have been validated to predict annual rates of ischemic stroke and bleeding, respectively. In order to provide context for the results given the absence of a control group, analyses were performed to compare EWOLUTION event rates to these historical rates for patients of a similar risk profile. Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.  For more information, visit www.bostonscientific.com and connect on Twitter and Facebook. This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words.  These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance.  These forward-looking statements include, among other things, statements regarding our business plans, clinical trials and product performance and impact.  If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements.  These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release.  As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors.  All of these factors are difficult or impossible to predict accurately and many of them are beyond our control.  For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter.  We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.  This cautionary statement is applicable to all forward-looking statements contained in this document. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/boston-scientific-announces-positive-european-registry-results-for-watchman-left-atrial-appendage-closure-device-300456874.html


The CbAS is similar to RFA in being deployed with an endoscopic catheter but uses extreme cold instead of heat to destroy diseased tissue in the esophagus. In a procedure known as cryoballoon ablation, nitrous oxide (N 0) cryogen is delivered through a handheld controller in combination with a self-sizing balloon catheter that is inserted into the working channel of a 3.7 mm therapeutic endoscope. The CbAS has been used in nearly 900 procedures to date. The synopses of the study results released for Digestive Disease Week are: Physician Learning Curve. Studies show that physicians must perform about 30 RFA procedures to overcome the effect of learning curve on treatment outcomes.1 This study aimed to determine the learning threshold for ablation of Barrett's esophagus with the CbAS. The researchers analyzed prospectively collected cryoablation procedure data from patients with neoplastic Barrett's esophagus treated at a single academic institution. They concluded that the learning curve effect for CbAS is reached at about 18 cases, after which efficiency plateaus. Patient Experience. Two studies in the Netherlands2 compared post-procedural pain in 79 Barrett's esophagus patients treated with RFA patients and 20 treated with focal cryoballoon ablation. In both studies, all visible Barrett's esophagus was treated, including circumferential treatment of the gastroesophageal junction. Pain was assessed immediately after the procedures and by telephone on Day 2. Patients were asked to apply pain scores from zero (no pain) to 10 (worst pain possible). Immediately after the procedure, 53% of cryoballoon ablation patients reported severe pain (score greater than 3), versus 24% of RFA patients. However, on Day 2, 46% of RFA patients reported severe pain, versus 18% of cryoballoon ablation patients. "This could suggest a shortened pain course after cryoballoon ablation compared with RFA," said the principal investigator Prof. Bas Weusten, Gastroenterology & Hepatology, St. Antonius Hospital, Nieuwegein, Netherlands. Treatment for ESCN. Esophageal squamous cell cancer arises from esophageal squamous cell neoplasia (ESCN) and is highly lethal. A multi-site study3 assessed the safety and efficacy of focal cryoballoon ablation for eradicating ESCN. Forty-two patients (98%) were successfully treated. Thirty-five of 40 patients (88%) had complete eradication of unstained lesions (USL) upon a single treatment session; five patients (12%) with persistent USL were successfully re-treated. Three developed superficial self-limited mucosal laceration upon balloon inflation; two of these were successfully treated three months later and one did not return. Dr. Gui-Qi Wang, Department of Endoscopy, Cancer Institute and Hospital Chinese Academy of Medical Sciences in Beijing, China stated, "Although longer-term follow-up data is pending, early results of our multicenter study suggest that focal cryoballoon ablation is safe, well-tolerated and highly effective in inducing complete endoscopic and histologic response." Treatment for GAVE. GAVE is an uncommon cause of upper gastrointestinal bleeding. Endoscopic management has been mainly thermoablative, but balloon cryoablation is emerging as an alternative. This multi-center study4 reviewed data from 10 patients with refractory GAVE who were treated with balloon cryotherapy. These were patients who continued to receive treatment for GAVE despite prior non-cryoballoon therapy. Each patient received one to four cryoballoon treatments (median two). Technical success was achieved in all patients. Follow-up endoscopy showed improvement in eight patients; one patient showed no improvement in the three months post-cryotherapy. No adverse events were reported. "Cryoballoon therapy is a feasible and safe modality that can be used to treat GAVE," reports Dr. Amrita Sethi, Division of Digestive and Liver Disease, Columbia University Medical Center, New York, NY. "Further studies are needed to evaluate long-term outcomes for this modality and to compare results to standard therapies." Swipe Cryoballoon Ablation Technique. Ablation devices for dysplastic Barrett's esophagus are effective, but none offer the attributes for widespread adoption because of length of procedure time and ease of use. Other factors include side effects and lack of predictability of ablation depth. This multi-center study5 evaluated the safety, feasibility and dose response of a novel swipe balloon catheter developed by C2 Therapeutics (to be marketed as the C2 CryoBalloon® 90 Ablation System), which delivers 3 cm of ablation in less than 60 seconds. The technique was tested in domestic swine and six human patients. The swipe technique delivered uniform and predictable ablation with mucosal and submucosal necrosis in animal and human esophagus. All the animals tolerated the ablations without difficulty and were able to eat and gain weight afterward. The human patients also tolerated the procedure without adverse events. Investigators concluded that because of its ease of use, the device merits further clinical study in treating dysplastic Barrett's esophagus. "These studies reinforce C2 Therapeutics' commitment to improving treatment for patients affected by Barrett's esophagus and other diseases of the gastrointestinal system," said Peter Garcia-Meza, President and CEO. "We continue to develop new design configurations to treat unmet needs in patients with diverse anatomy and disease characteristics. We sincerely appreciate the dedication and support of our collaborating study investigators and participating trial centers." Barrett's esophagus develops as a result of chronic injury from gastroesophageal reflux disease (GERD). Over time, the normal esophageal lining is replaced with abnormal cells (Barrett's esophagus), putting patients at greater risk of developing cancer of the esophagus. Founded in 2007 and headquartered in Redwood City, California, C2 Therapeutics developed the C2 CryoBalloon® Ablation System for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's esophagus with dysplasia. Acquired by PENTAX Medical – a division of HOYA Group – in January 2017, C2 Therapeutics continues to innovate and enhance its C2 CryoBalloon® Ablation System as a new standard for simplicity in the eradication of esophageal disease. For more information about C2 Therapeutics, please visit www.c2therapeutics.com. 1 George Kunnackal John, et al, Cryoballoon Ablation for Barrett's Esophagus: A Prospective Single Operator Learning Curve and Time-Efficiency Study, TU1170, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 2 Sanne N. van Munster, et al, Post-Procedure Pain Associated with Endoscopic Ablation Therapy of Barrett's Esophagus: Post-Hoc Comparison Between Radiofrequency Ablation and Cryoballoon Ablation, TU1186, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 3 Yan Ke, et al, Safety and Efficacy of Endoscopic Focal Cryoballoon Ablation for the Treatment of Esophageal Squamous Cell Intraepithelial Neoplasia, M01997, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 4 Anish Patel, et al, Endoscopic Management of Refractory Gastric Antral Vascular Ectasia (GAVE) with Cryoballoon Therapy: A Case Series, MO1986, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 5 Brian E. Louie, et al, Evaluation of a Novel Swipe Cryoballoon Ablation System in Bench, Porcine, and Human Esophagus, MO2010, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. i C2 CryoBalloon Focal Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's esophagus with dysplasia.


Blok J.L.,University of Groningen | Boersma M.,University of Groningen | Terra J.B.,University of Groningen | Spoo J.R.,University of Groningen | And 5 more authors.
Journal of the European Academy of Dermatology and Venereology | Year: 2015

Background Treatment of hidradenitis suppurativa (HS) is a difficult undertaking, especially as there is no consensus on what surgical technique is preferred. At our centre severe HS (Hurley II/III) is operated under general anaesthesia, mostly with the STEEP procedure. Objectives To investigate characteristics, surgical outcomes and patient satisfaction of HS patients who underwent deroofing or STEEP under general anaesthesia. Methods A clinical records-based retrospective analysis was conducted of all patients who had surgery under general anaesthesia between 1999 and 2013. Patient satisfaction was retrospectively investigated with questionnaires. Results A total of 482 operations (363 primary operations and 119 re-operations) were performed during the study period. The proportion of women in the included population was 68%. The median diagnostic delay (patient's and doctor's delay) was 6.5 years. Relapses occurred after 29.2% of primary operations. Women had higher relapse rates than men [odds ratio 2.85 (1.07;7.61)]. Hypergranulation of the wound was the most common complication and occurred in 7% of all operations. The median score patients attributed to the medical effect of surgery was eight of 10 (zero corresponding to very dissatisfied and 10 to very satisfied). Conclusion The diagnostic delay in HS is long due to a lack of knowledge in both patients and health care professionals, indicating that there is a need for education. Deroofing and the STEEP are effective surgical procedures in severe cases of HS and lead to a relatively high patient satisfaction. The postoperative relapse risk is higher in women. Prospective studies are required for the development of clear guidelines on the appropriate choice of surgery. © 2015 European Academy of Dermatology and Venereology.


Blok J.L.,University of Groningen | Spoo J.R.,University of Groningen | Leeman F.W.J.,Antonius Hospital | Jonkman M.F.,University of Groningen | Horvath B.,University of Groningen
Journal of the European Academy of Dermatology and Venereology | Year: 2015

Background: Surgery is the only curative treatment for removal of the persistent sinus tracts in the skin that are characteristic of severe hidradenitis suppurativa (HS). Complete resection of the affected tissue by wide excision is currently regarded as the preferred surgical technique in these cases. However, relatively large amounts of healthy tissue are removed with this method and suitable skin-tissue-saving techniques aiming at creating less-extensive surgical defects are therefore needed in severe HS. Method: We describe a skin-tissue-saving surgical technique for HS Hurley stage II-III disease: the Skin-Tissue-sparing Excision with Electrosurgical Peeling (STEEP) procedure. Discussion: In contrast to wide excisions that generally reach into the deep subcutaneous fat, the fat is maximally spared with the STEEP procedure by performing successive tangential excisions of lesional tissue until the epithelialized bottom of the sinus tracts has been reached. From here, secondary intention healing can occur. In addition, fibrotic tissue is completely removed in the same manner as this also serves as a source of recurrence. This tissue-sparing technique results in low recurrence rates, high patient satisfaction with relatively short healing times and favourable cosmetic outcomes without contractures. © 2014 European Academy of Dermatology and Venereology.


Van Der Valk M.E.,University Utrecht | Mangen M.-J.J.,University Utrecht | Leenders M.,University Utrecht | Dijkstra G.,University of Groningen | And 17 more authors.
Gut | Year: 2014

Objective The introduction of anti tumour necrosis factor-α (anti-TNFα) therapy might impact healthcare expenditures, but there are limited data regarding the costs of inflammatory bowel diseases (IBD) following the introduction of these drugs. We aimed to assess the healthcare costs and productivity losses in a large cohort of IBD patients. Design Crohn's disease (CD) and ulcerative colitis (UC) patients from seven university hospitals and seven general hospitals were invited to fill-out a web-based questionnaire. Cost items were derived from a 3 month follow-up questionnaire and categorised in outpatient clinic, diagnostics, medication, surgery and hospitalisation. Productivity losses included sick leave of paid and unpaid work. Costs were expressed as mean 3-month costs per patients with a 95% CI obtained using non-parametric bootstrapping. Results A total of 1315 CD patients and 937 UC patients were included. Healthcare costs were almost three times higher in CD as compared with UC, €1625(95% CI €1476 to €1775) versus €595 (95% CI €505 to €685), respectively (p<0.01). Anti-TNFα use was the main costs driver, accounting for 64% and 31% of the total cost in CD and UC. Hospitalisation and surgery together accounted for 19% and <1% of the healthcare costs in CD and 23% and 1% in UC, respectively. Productivity losses accounted for 16% and 39% of the total costs in CD and UC. Conclusions We showed that healthcare costs are mainly driven by medication costs, most importantly by anti-TNFα therapy. Hospitalisation and surgery accounted only for a minor part of the healthcare costs.


News Article | November 7, 2016
Site: www.eurekalert.org

WASHINGTON - Nov. 2, 2016 - Results from a randomized, multicenter trial failed to show non-inferiority of hybrid, ultra-thin strut sirolimus-eluting stents (Osiro SES) with a biodegradable polymer compared to thin-strut everolimus-eluting stents (Xience EES) with a durable polymer in terms of in-segment late lumen loss in successfully treated chronic total occlusions. In addition, although the rate of binary restenosis was low overall in this complex lesion subset, it was higher with the Osirio SES compared with the Xience EES. Findings from the PRISON IV trial were reported today at the 28th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine. The study was also published in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions. "Treating chronic total occlusions can be challenging due to their long lengths and the presence of greater degrees of calcium. They often require long stents with high radial strength to maintain acute gain and to minimize late vessel recoil after percutaneous coronary intervention," said lead investigator, Koen Teeuwen, MD from St. Antonius Hospital in Nieuwegein, The Netherlands. Between February 2012 and June 2015, a total of 330 consecutive patients with successfully recanalized native total or chronic total coronary occlusions were randomized to the hybrid sirolimus-eluting stent or the everolimus-eluting stent in two Belgian and six Dutch high-volume PCI centers. Follow-up angiography was performed at nine months after the procedure. In addition, clinical follow-up was obtained during the hospital stay and at one, six, nine and 12 months. The primary non-inferiority end point was in-segment late lumen loss assessed at nine months by angiography. Secondary angiographic end points included: in-stent late lumen loss, minimal lumen diameter, in-stent and in-segment percentage of diameter stenosis, binary restenosis and reocclusions at nine months. Secondary individual and composite clinical end points were clinically indicated target lesion revascularization/target vessel revascularization, myocardial infarction, death (cardiac and non-cardiac), stent thrombosis, target vessel failure, and major adverse cardiac events. At nine months, angiography was available in 281 of 330 (85%) patients. The primary non-inferiority end point of in-segment late lumen loss was not met for SES compared with EES (0.13±0.63 mm vs. 0.02±0.47 mm; P=0.08, 2-sided; difference=0.11 mm; 95% confidence interval, -0.01 to 0.25; Pnon-inferiority=0.11, 1-sided). In-stent late lumen loss was comparable between SES and EES (0.12±0.59 versus 0.07±0.46 mm; P=0.52). The incidence of in-stent/in-segment binary restenosis was higher with SES compared to EES (8.0% vs. 2.1%; P=0.028) with comparable rates of reocclusions (2.2% vs. 1.4%; P=0.68). Clinically indicated target lesion and vessel revascularization (9.2% vs. 4.0%; P=0.08 and 9.2% vs. 6.0%; P=0.33), target vessel failure (9.9% vs. 6.6%; P=0.35) and definite or probable stent thrombosis (0.7% vs. 0.7%; P=1.0) were comparable in the SES and EES group. Clinical follow-up at 12 months was available in 99% of all subjects. Clinically indicated target lesion and vessel revascularization, target vessel failure and MACE were comparable between both groups. Two subjects in the SES group received non-clinical TLR with balloon angioplasty after observing severe stent strut malapposition with optical coherence tomography at nine months. There was only one probable or definite stent thrombosis in each stent group (0.7% vs. 0.7%; P=1.0). "The findings of the study show that the non-inferiority of in-segment late lumen loss was not met for SES against EES in successfully recanalized chronic total occlussions," said Dr. Teeuwen. "In addition, the rate of binary restenosis was significantly higher with SES. Future developments in stent technology should focus on the challenging characteristics of CTOs to improve device efficacy and clinical outcomes." The PRISON IV trial was funded by unrestricted research grants from Biotronik and Abbott Vascular. Dr. Teeuwen reported no relevant disclosures. The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease. Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world's premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field. For more information, visit http://www. and http://www. .


News Article | November 8, 2016
Site: www.prweb.com

uBiome, the leading microbial genomics company, has appointed Dr. Elisabeth Bik – who joins the uBiome team in a full-time role from Stanford University School of Medicine – as its new Science Editor. Dr. Bik is regarded by her research peers as one of the world’s authorities on the science of the microbiome. At uBiome, Dr. Bik’s primary focus will be on leading the ongoing publication of scientific findings by the company. Since 2002, Dr. Bik has been a Research Associate at Stanford University School of Medicine, where she has specialized in the composition of the intestinal microbiota of healthy subjects and those with liver diseases, the microbiota of marine mammals, and isolating and detecting microbial DNA from clinical samples. Additionally, since 2014, she has been the editor of the highly respected online Microbiome Digest, a daily summary of scientific papers about microbiome and microbiology research, with a considerable readership in the scientific community. Dr. Bik will continue to edit Microbiome Digest as part of her new position with uBiome. Dr. Bik has authored and co-authored over 30 papers, including the influential Diversity of the Human Intestinal Microbial Flora, which has been cited well over 4,000 times. This ground-breaking research, carried out in collaboration with Stanford’s infectious disease specialist, Dr. Paul B. Eckburg, was published in 2005 – three years before the Human Microbiome Project commenced its work. Described by the journal Nature as a “sharp-eyed microbiologist,” in April 2016, Dr. Bik worked closely with two editors-in-chief at microbiology journals to conduct an analysis of over 20,000 published microbiology, immunology, cancer research, and general science papers, specifically looking for images that were inappropriately duplicated or altered. Such images were found in 3.8% of the papers analyzed. The reputable website Retraction Watch subsequently described her as a “behind-the-scenes force in scientific integrity.” After receiving her PhD at Utrecht University in the Netherlands, Dr. Bik worked at the Dutch National Institute for Health, and the St. Antonius Hospital in Nieuwegein, Utrecht in the Netherlands. In 2002, she joined the Department of Microbiology and Immunology at Stanford University School of Medicine, where, in May 2016, she was awarded Stanford’s prestigious “Microbiome Pioneer” award for her ongoing contributions to science in editing and publishing Microbiome Digest. Dr. Bik brings her considerable experience and expertise to uBiome, a pioneer of applying next generation high-throughput DNA sequencing technology to deliver highly detailed analyses of the human microbiome, the ecosystem of trillions of bacteria that populate the human body. Bacteria in the gut play critical roles in good health, such as supporting digestion and the synthesis of vitamins. However, pathogenic bacteria are associated with a range of conditions – some of them serious – such as celiac disease and inflammatory bowel diseases (including both Crohn’s disease and ulcerative colitis), irritable bowel syndrome, esophageal reflux and esophageal cancer, Clostridium difficile infection, colorectal cancer, and many others. Dr. Elisabeth Bik, new uBiome Science Editor, says: “As someone who has worked in and around the area for over twenty years, it’s rewarding that there has been such a huge increase in interest in the microbiome recently, but, of course, this has been driven by remarkable research driven by my peers and by uBiome. Publishing is, of course, a cornerstone of science, which is why I’m happy that uBiome is placing such great emphasis on ensuring that its work goes through the rigorous time-tested peer-review process, and I’m delighted that I’ll be enabling them to do so as the new Science Editor.” Dr. Jessica Richman, co-founder and CEO of uBiome, says: “We’ve long been inspired by Dr. Bik’s work to disseminate information about our field through the Microbiome Digest. We’re delighted to welcome her to our team and thrilled to work with such a respected expert.” uBiome was founded in 2012 by researchers educated at Stanford, Oxford, and UCSF. The company is funded by Andreessen Horowitz, Y Combinator, and other leading investors. uBiome’s mission is to explore important research questions about the microbiome and to develop accurate and reliable clinical tests based on the microbiome.


Ter Schure J.M.A.,University Utrecht | De Vries M.,Antonius Hospital | Weel J.F.L.,Medical Center Leeuwarden | Van Roon E.N.,Medical Center Leeuwarden | Faber T.E.,Medical Center Leeuwarden
Pediatric Infectious Disease Journal | Year: 2013

Introduction: Dientamoeba fragilis infection in children is common, and its incidence has increased since the introduction of more sensitive molecular techniques. There is no consensus on the optimal treatment. Current medical practice in the Netherlands is to treat symptomatic children with clioquinol or metronidazole. This study attempts to obtain more information about the clinical picture of D. fragilis infection in children and to evaluate responses to both antiparasitic drugs. Methods: Children <18 years of age with a positive stool polymerase chain reaction test for D. fragilis infection were retrospectively evaluated. Clinical data and effectiveness of treatment were analyzed by examining patient's hospital records from the Medical Centre Leeuwarden by repeated analysis of stool samples by the Centre for Infectious Diseases in Friesland. Results: We analyzed 238 patients with an average age of 8.5 years (±4.2 years). Most patients were symptomatic (95.8%) and presented with abdominal pain (72.7%), loose stools (32.8%) and hard stools (24.8%). Coinfection with other gastrointestinal pathogens was present in 29 patients (12.2%). A higher incidence of infection was found in the winter. Clioquinol had a higher clinical success rate than metronidazole (74.7% versus 55.2%, P= 0.047). Conclusion: These results suggest that clioquinol could be more effective than metronidazole in alleviating symptoms of D. fragilis infection in children, but double-blind prospective placebo-controlled studies should be performed before final conclusions can be made. Copyright © 2013 by Lippincott Williams & Wilkins.


Vasak B.,University Utrecht | Graatsma E.M.,University Utrecht | Hekman-Drost E.,Gelre Hospital | Eijkemans M.J.,University Utrecht | And 3 more authors.
American Journal of Obstetrics and Gynecology | Year: 2013

Objective We sought to study whether uterine electromyography (EMG) can identify inefficient contractions leading to first-stage labor arrest followed by cesarean delivery in term nulliparous women with spontaneous onset of labor. Study Design EMG was recorded during spontaneous labor in 119 nulliparous women with singleton term pregnancies in cephalic position. Electrical activity of the myometrium during contractions was characterized by its power density spectrum (PDS). Results Mean PDS peak frequency in women undergoing cesarean delivery for first-stage labor arrest was significantly higher (0.55 Hz), than in women delivering vaginally without (0.49 Hz) or with (0.51 Hz) augmentation of labor (P =.001 and P =.01, respectively). Augmentation of labor increased the mean PDS frequency when comparing contractions before and after start of augmentation. This increase was only significant in women eventually delivering vaginally. Conclusion Contraction characteristics measured by uterine EMG correlate with progression of labor and are influenced by labor augmentation. © 2013 Mosby, Inc. All rights reserved.

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