In early 2009, six medical professional societies got together to write a guide for 180 cardiac revascularization procedures.
A recent survey, however, shows that there may not be consensus amongst the doctors who practice the surgical and percutaneous coronary intervention procedures.
The survey, which was published in the April 5, 2011 issue of Journal of the American College of Cardiology included the views of 85 cardiologists (44 interventional and 41 noninterventional) who rated the "appropriateness criteria" of 68 of the 180 revascularization procedures prior the publication of the 2009 guidance.
The physicians’ views were compared to one another and that of the AUC (appropriate use criteria) Technical Panel, which included four interventional cardiologists, eight noninterventional cardiologists, four cardiac surgeons, and one payer and represented a range of cardiology imaging groups. The variation in some of the findings were wide:
"If 25% or more of the individual physicians in the surveyed group gave the indication a score outside of the three-point range for the category assigned by the group overall, the indication was deemed to have "nonagreement." On 16 of the 36 indications deemed appropriate by the AUC technical panel (44%), at least 25% of the surveyed physicians gave a rating in nonagreement within their overall consensus (a rating not within the same three-point group as the median). There was nonagreement on 70% (7 out of 10) of the inappropriate indications among the surveyed physicians. Also, there was substantial variation in appropriateness ratings between individual physicians and the AUC technical panel (weighted kappa range 0.05-0.76)," writes heartwire.
Here’s a roundup of recent clinical trial and scientific study news:
- Detroit Medical participates in implantable cardiac monitor study
Detroit Medical Center (DMC) Cardiovascular Institute (CVI) announced its first implant of the AngelMed Guardian cardiac monitor and alert system as part of the device’s ALERTS Pivotal Study. The system, which the FDA granted investigational device exemption, is designed to reduce the time it takes patients to get to the emergency room during an impending heart attack. The device won CE Mark approval for marketing in Europe in Sept. 2010.
- Nordion reports TheraSphere Phase II trial results
Nordion Inc. (NYSE:NDZ) reported results from the first multi-site, Phase II clinical trial to evaluate TheraSphere for treatment of metastatic liver cancer. The trial evaluated factors including safety and tumour response in patients with liver metastases — cancerous tumours that spread to the liver from other sites in the body. The overall tumour response, including stable disease, was 90 percent in metastatic neuroendocrine tumours and 69.2 percent in all treatment groups.
- Cambridge Heart’s MTWA test featured in Diagnostic and Interventional Cardiology
Cambridge Heart, Inc. (OTC:CAMH) announced that its Microvolt T-Wave Alternans (MTWA) test was recently featured in Diagnostic and Interventional Cardiology (DAIC) as the Case of the Week. The clinical case illustrates the prognostic value of the test in a patient who received an implantable cardioverter defibrillator (ICD) after testing positive for MTWA.
- Stemedica treats first patient with ischemic allogeneic mesenchymal stem cells
Stemedica Cell Technologies Inc. announced that its specially formulated ischemic adult allogeneic mesenchymal stem cells have been successfully used to treat the first patient in an ischemic stroke study conducted at the University of California, San Diego (UCSD). A total of 35 patients will be enrolled in the clinical trial entitled: “A Phase I/II, Multi-Center, Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects with Ischemic Stroke.”
- Life Technologies initiates trial on sequence-based typing solution
Life Technologies Corp. (NSDQ:LIFE) announced that it is the first life science tools provider entering clinical trials to prove the safety and effectiveness of their DNA sequence-based typing (SBT) platform for analysis of the Human Leukocyte Antigen (HLA) system. Submission for 510(k) clearance of this SBT platform will follow completion of the clinical trials, which is anticipated this summer.
- Harvest Technologies lands FDA approval for IDE trial on autologous adult stem cells
Harvest Technologies Corp. announced that the FDA has approved the company sponsored 210-patient IDE clinical trial to be conducted at twenty-five sites in the U.S. using the company’s proprietary Bone Marrow Aspiration Concentrate (BMAC) System to treat patients with non-reconstructable Critical Limb Ischemia (CLI).
- St. Luke’s Episcopal Hospital implants a continuous-flow total artificial heart
Doctors at the Texas Heart Institute (THI) at St. Luke’s Episcopal Hospital (SLEH) have successfully implanted the first continuous-flow total artificial heart in a desperately ill patient facing imminent death. On March 10, Drs. Bud Frazier and Billy Cohn removed the heart of 55–year-old Houstonian Craig Lewis and replaced it with the artificial heart, which had been developed at THI over the last five years in collaboration with industry and funded by grants from the National Institute of Health and the Dunn Foundation.
- Study: SPIRIVA HandiHaler prolonged time to first COPD exacerbation
A new study published in The New England Journal of Medicine showed that SPIRIVA HandiHaler (tiotropium bromide inhalation powder), a long-acting anticholinergic, was significantly more effective at preventing Chronic Obstructive Pulmonary Disease (COPD) exacerbations than salmeterol HFA-MDI (hydrofluororalkane-metered dose inhaler).
- Mayo Clinic finds that cardiac pacing helps epilepsy patients
Mayo Clinic researchers found that cardiac pacing may help epilepsy patients with seizure-related falls due to ictal asystole, an unusual condition in which the heart stops beating during an epileptic seizure. The study was recently published in the journal Epilepsia.
- OrbusNeich touts Genous data
OrbusNeich announced that 12-month outcomes data from a subset analysis of the global e-HEALING registry were published online ahead of print in the Journal of Interventional Cardiology and demonstrated the effectiveness and safety of the company’s Genous Stent in diabetic patients, with low definite and probable stent thrombosis (ST) comparable to non-diabetics.
- Successful bridge to lung transplant with the Hemolung respiratory assist system
Heinz-Dieter Hilgers comes only once per month to the Ruhrlandklinik hospital for a routine check-up. Nine months ago, in June 2010, his situation was dramatic: Suffering from chronic obstructive pulmonary disease (COPD) for almost two years, Hilgers, 49 years young, had been listed for lung transplant since April 2009. While waiting for an organ, he became more and more sick, requiring long-term oxygen therapy since February and non-invasive ventilation since May 2010. These treatments however did not really help: “Taking a shower took me one hour,” he says, and adds, “I couldn’t ride my bike. Even dining was an effort.”