ORLANDO, Florida – Medical Device Daily, quite obviously, focuses on healthcare devices and instrumentation, but these areas frequently interlock with both drug and other non-drug technologies.
The variety and tantalizing potential of these related technologies are highlighted well at every American College of Cardiology (ACC; Bethesda, Maryland) conference. And these are technologies that device manufacturers and users should be aware of either as early warning for competitive advantage or, more appropriately, for patients and clinicians, because they put on our radar the opportunities for better care and better outcomes at some future time.
Following are a few short notes on some of these technologies reported on at this year's ACC gathering, which ended its four-day run yesterday.
No matter how effective a diagnostic or treatment technology, proper methods of care – frequently, follow-on care with medications – are considered essential to maximizing opportunity for the best outcomes, meaning reduced death and co-morbidities and improved quality of life.
In this context, electronic medical record programs are being boosted as a way to improve caregiver efficiency. But James Dove, MD, presented research suggesting that the physician also needs a dovetailing computer program that provides a method for improved quality-of-care compliance on his or her part.
Dove described a computerized quality improvement program that reminds physicians concerning a list of seven approved cardiovascular treatment guidelines and gives visual alerts if particular guidelines are not checked off as met.
The researchers looked at physician compliance using the computer program in their treatment of 5,000 patients, and 3,000 other patients treated by doctors without the computer program.
The study found that when the computer tool was used, 100% of the physicians were compliant in prescribing aspirin – one of the key goals – compared to only about 90% without the computer program.
Across all seven guidelines, the computer program was associated with 100% physician guideline compliance, vs. just 26% adherence to all guidelines without it.
"Memory fails us," said Dove, offering one reason for the difference. And he noted that with increased documentation of care "there is less and less time to think about how to manage the patient." He said also that this is particularly true in cardiovascular care, with ongoing changing rules of care and the number of team members required to carry out quality care.
In other reports:
• Another interesting use of computer technology in quality improvement was demonstrated with the use of the Remind software from Siemens Medical Solutions (Malvern, Pennsylvania). Researchers compared use of the Remind artificial intelligence software, an automated extraction system, with manual chart extraction from an electronic medial record.
Manual extraction and data entry concerning 136 patients required 136 hours compared to three hours using Remind software. A total of l2,289 data elements were identified, with compliance agreement in 1,912 and disagreement in 377 involving 2.5% to 35% of patients for various parameters. Remind was found to be correct in compliance disagreements at 57% and manual extraction was correct in the remaining 43%.
Remind identified adherence at 55.7% and 38.2% respectively, compared to guideline adherence determined by manual extraction.
Researchers concluded that Remind can access guideline adherence at least as accurately as manual chart abstraction. And the use of Remind for quality improvement and research can result in improve savings, better resource utilization and may improve data extraction quality, researchers said.
• Autologous myoblast transplantation (AMT) remains efficacious and safe in patients undergoing coronary artery bypass grafting (CABG), according to a U.S. multicenter study that found these goals achieved in a three-year follow-up study.
In AMT, skeletal muscle cells, or myoblasts, are taken from the patient's thigh and cultured for several weeks. They are then injected into the heart, at the area of the infarction, to promote the growth of new, viable heart tissue. The ultimate goal of AMT is to heal the heart after myocardial infarction (MI) and improve its pumping ability, said Nabil Dib, MD, of the Arizona Heart Institute (Phoenix).
In this feasibility and safety trial, 24 patients with a prior MI and a left ventricular ejection fraction of less than 40% who were scheduled to undergo CABG were given AMT injections in one of four escalating doses, ranging from 10 million to 300 million cells. Post procedural monitoring included positron emission tomography (PET) and MRI.
The PET and MRI scans showed evidence of new heart tissue formation, and heart function was increased from 21% to 34%, an improvement of about one New York Heart Association class, Dib said.
• Adding the antiplatelet agent clopidogrel to standard reperfusion therapy for patients with ST-elevation myocardial infarction (STEMI) significantly reduces their rate of blocked culprit coronary artery, death or recurrent MI by the time of angiography. It does this safely, with no increase in bleeding or intracranial hemorrhage, according to a large, multicenter trial.
In the Clopidogrel as Adjunctive Reperfusion Therapy (CLARITY) Thrombolysis In Myocardial Infarction (TIMI) 28 trial, 3,491 STEMI patients undergoing fibrinolysis were randomized to clopidogrel, followed by another lesser dose, or placebo for an average of four days, until angiography. Standard fibrinolytic agents and anticoagulants were used and all patients received aspirin.
Patients who received clopidogrel had a significantly lower rate of blocked culprit coronary artery, death or recurrent MI than control patients, a benefit seen regardless of age, gender, type of fibrinolytic or type of heparin.
By 30 days, patients treated with clopidogrel had a lower rate of death due to cardiovascular causes, recurrent MI or recurrent ischemia leading to the need for urgent revascularization.
• Gene therapy is frequently touted as the largest new wave of the future, but one of the studies presented at ACC indicated no efficacy in the exercise improvement of class II to class IV angina patients, though the therapy was safe.
The goal of this type of gene therapy is to grow new blood vessels in patients with myocardial ischemia. After earlier trials (AGENT and AGENT-2) showed that intracoronary injections of the adenovirus for fibroblast growth factor 4 (FGFR-4) showed safety and some favorable effects on exercise tolerance and blood flow to the heart in these patients, investigators had high hopes that AGENT-3 would finally demonstrate real improvement in their ability to exercise, said Timothy Henry, MD, of the Minneapolis Heart Institute (Minneapolis).
In AGENT-3, 416 patients at 65 centers in the U.S. were randomized to placebo or low dose and high dose of the adenovirus delivered via intracoronary injection. The patients did not need immediate revascularization for the angina. Patients were then tested on a treadmill at three months and six months to see if their ability to walk had improved.
However, walking times remained unchanged in all groups, despite excellent results pertaining to safety.
Some improvement was seen in a subset of very high-risk patients, the researchers said, including those with more severe Class III and Class IV angina.
Henry noted: "These results mean that if you're not that sick to start with, the gene therapy is not going to make you much better. But it looks as if it is possibly having a better effect in more seriously ill angina patients. In the future, we will probably need to confine this to higher-risk patients."