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A tiny pacemaker without leads becomes available in Europe, and interventional cardiologists make the case for more simulation in training.
Pacing Without Leads
The first leadless pacemaker -- which is less than one-tenth the size of a conventional pacemaker -- has been approved for use in Europe.
Implanting the device is less invasive than with traditional pacemakers because it can be delivered via a catheter into the heart.
"The elimination of the visible lump and scar at a conventional pacemaker's implant site, in addition to the removal of patient activity restrictions that may prevent the dislodgement or damage to a conventional lead, will potentially improve the quality of life for patients with this technology by allowing most to continue living active, uninhibited lifestyles," according to a press release from St. Jude Medical, which recently acquired Nanostim, the company that made the device.
Initial results from the first-in-man LEADLESS study of the new pacemaker, presented earlier this year at the Heart Rhythm Society meeting, showed successful implantation in 32 of 33 patients and performance comparable with traditional pacemakers with leads. The one unsuccessful implantation occurred in a 70-year-old who died of a stroke 5 days after suffering cardiac perforation and tamponade from the implantation procedure.
St. Jude has received the go-ahead from the FDA to perform a pivotal trial of the device in the U.S.
Interventional Cardiologists Want More Simulation
The use of medical simulation should grow to bolster the training of interventional cardiologists and ultimately improve patient care, according to a clinical document from the Society for Cardiovascular Angiography and Interventions (SCAI).
The document -- published in Catheterization and Cardiovascular Interventions -- detailed the current use of simulation in the field and provided recommendations for expanding the use of the technology, particularly for procedures that are complex or infrequently performed.
The recommendations included standardization of cases to enable the practice of essential skills, use of a standardized curriculum to meet evidence-based learning standards, performance of large-scale studies to evaluate simulation training, and integration of formal simulation programs into annual meetings.
"Interventional cardiology is particularly well-suited for simulation because the procedures are complex, learning curves can be steep, and complications can be life-threatening," lead author Sandy Green, MD, of Geisinger Medical Center in Danville, Pa., said in a statement. "While simulation cannot replace real patient experience, it provides a safe arena to develop and refine skills that improves overall patient care."
Lasers Pry Out Stubborn Inferior Vena Cava Filters
An excimer laser may help remove inferior vena cava filters that have become embedded in the endothelium, a single-center study showed.
The use of inferior vena cava filters to prevent pulmonary embolism has grown in recent decades and in 2010, the FDA issued a warning about the devices related to risks of device migration, device embolization, perforation of the inferior vena cava, and filter fracture. The agency said physicians should consider removing the filters as soon as protection from pulmonary embolism was no longer needed.
But sometimes removal isn't straightforward. William Kuo, MD, of Stanford University in Stanford, Calif., and colleagues studied the use of excimer laser-assisted removal of embedded filters that could not be removed using standard methods. The 100 patients included in the study required removal of the devices for various reasons, including filter-related acute inferior vena cava thrombosis, chronic inferior vena cava occlusion, and pain from retroperitoneal or bowel penetration.
As reported in Circulation: Cardiovascular Interventions, laser-assisted retrieval was successful in 98% of the cases, with a major complication rate of 3% and a minor complication rate of 7%. There were four adverse events: two coagulopathic hemorrhages, a renal infarction, and one case of cholecystitis.
"This procedure has the potential to achieve successful inferior vena cava filter removal in thousands of patients to alleviate filter-related morbidity, to prevent further risks associated with long-term implantation, and to eliminate the need for filter-related lifelong anticoagulation," Kuo and colleagues wrote.
Too Little Dietary Fiber Equals Higher Heart Risks
U.S. adults who ate the most fiber had lower cardiometabolic risks, according to a study in the American Journal of Medicine.
Cheryl Clark, MD, ScD, of Brigham and Women's Hospital in Boston, and colleagues looked at trends in dietary fiber intake in 23,168 U.S. adults from 1999 to 2010 and examined associations between intake and cardiometabolic risks using information from the National Health and Nutrition Examination Survey.
In general, dietary fiber intake was lower than recommended by the Institute of Medicine. Mexican Americans consumed the most, followed by non-Hispanic whites and non-Hispanic blacks.
Individuals who ate the most fiber had 22% to 34% reduced relative risks of metabolic syndrome, cardiovascular inflammation, and obesity. The associations between intake and risks of obesity and metabolic syndrome were significant among non-Hispanic whites only.
"Our findings underscore the need for additional randomized controlled trial data to shape recommendations for dietary fiber intake as a preventive strategy to reduce associated cardiometabolic risks," the researchers wrote. "Additional nutritional policies may be needed to increase adequate consumption of dietary fiber, in order to reduce cardiometabolic risk factors in diverse U.S. populations."