Women who undergo open-heart surgery are more likely than men to develop acute renal failure (ARF), according to research conducted at The Cleveland Clinic (Cleveland, Ohio). ARF is a serious complication of open-heart surgery and is strongly associated with an increased risk of mortality. The study examined the influence of gender and race on the frequency of ARF in post-operative, open-heart surgery patients. More than 24,000 patients underwent open-heart surgery at The Cleveland Clinic between 1993 and 2000, according to the clinic's department of cardiothoracic anesthesiology.

After eliminating patients for extraordinary risk factors, a total of 22,589 patients were evaluated. Of these, 6,738 (30%) were female, the largest number of female patients ever reported in research examining the relationship of gender and race to ARF after open-heart surgery. In addition, the study involved one of the largest numbers of black patients, 849, ever studied for the same purpose. The influence of race on the risk of ARF was not definitive, according to the research.

The primary outcome measured by the study was ARF (either requiring dialysis or not), while the secondary outcome was all-cause, post-operative mortality. Specifically, the study found that of 22,589 patients observed, overall incidence of ARF was 1.82%. Females were almost twice as likely to develop ARF than males, irrespective of other potential risk factors. The overall mortality rate was 2.2%.

Post-operative mortality following open-heart surgery is traditionally higher in women, and the study results were reflective of this fact. The mortality rate among females was 3.1% vs. 1.8% in males. Patients who developed ARF requiring dialysis had a sharply higher mortality rate of 61.2%, which was significantly greater in women (68.6%) than in men (56.5%). Patients with ARF not requiring dialysis had overall mortality of 14.1%, with no statistical difference between men and women. Patients who did not develop ARF by either of the definitions used for the study had a mortality rate of 0.68%.

"This study confirms the link between ARF and post-operative mortality following open-heart surgery," said Charuhas Thakar, MD, lead investigator of the study and a research scholar in the department of nephrology and hypertension at The Cleveland Clinic. "Analyzing gender as an independent risk factor has allowed us to gain new insight in understanding ARF in heart surgery patients. In addition, identifying such variables may help us to provide better care for patients at higher risk for developing ARF following heart surgery." Complete results of the study appear in the April edition of the American Journal of Kidney Diseases.

CPAP shown benefiting heart failure

Heart function can be significantly improved in patients with congestive heart failure and obstructive sleep apnea by treating this sleep disorder with a simple, easy-to-use, portable device, according to a first-ever randomized clinical trial of patients with heart failure conducted at Toronto General Hospital, University Health Network (UHN), Mount Sinai Hospital and the Toronto Rehabilitation Institute. The study was funded in part by fellowships from Respironics (Murrysville, Pennsylvania), a developer of products and therapies for treating obstructive sleep apnea (OSA) and other respiratory diseases in both home and clinical settings. The results were published in the March 27 issue of The New England Journal of Medicine.

CPAP consists of a small mask that is placed over the nose during sleep and is connected by tubing to an air pressure pump that is plugged into a wall socket. Air pressure in the tubing is transmitted to the mask and then flows continuously through the nose into the throat, propping it open and preventing it from collapsing during the night. This is designed to eliminate obstructive sleep apnea, estimated to be suffered by one-third of all heart failure patients, according to Respironics.

The study tested 24 patients with heart failure who were taking medications for the condition and also had obstructive sleep apnea. Twelve participants were assigned to receive medical therapy (medication) alone, and another 12 received treatment (medication) for their heart failure, plus treatment via CPAP. Patients were tested before and after one month of either receiving medication alone or both the CPAP treatment and medication.

In the patients receiving medication only, there was no change in the frequency of their obstructive sleep apnea episodes, which remained at 45 episodes per hour. In contrast, among the patients receiving the CPAP treatment in addition to medication, the episodes were reduced from 37 per hour to eight per hour an 80% reduction within one month. After one month, the patients on medication alone experienced no change in their heart function. In contrast, those who were treated with CPAP had a 9% increase in their left ventricular ejection fractions, from 25% to 34%.

In heart failure, the heart enlarges, which increases its workload and makes it less efficient in pumping blood. The group receiving medication only did not have any change in heart size. However, after one month of treatment with CPAP, the average dimension of the heart at the end of a beat was reduced from 55 mm to 52 mm. Other improvements with CPAP treatment included reductions in systolic blood pressure and decreases in heart beats per minute.

"Prior to this study, it had not been considered that heart failure might be adversely affected by something that goes on during sleep," said Douglas Bradley, MD, lead investigator of the study and head of the Sleep Research Laboratories at Toronto General Hospital, Mount Sinai and Toronto Rehabilitation Institute and director of the University of Toronto Center for Sleep Medicine and Circadian Biology. "We've demonstrated that obstructive sleep apnea is a previously unrecognized contributor to heart failure, and that a simple and specific therapy targeting sleep apnea can improve heart failure," he said.

In addition to the unrestricted research fellowships from Respironics, the study was supported by a Canadian Institutes of Health research grant and senior scientist award; a research fellowship from the Japan Information Center for Respiratory Failure Patients; Heart & Stroke Foundation of Ontario Career Scientist Award; postdoctoral support from Merck Frosst, SmithKline Beecham and Roche Pharmaceuticals; a Canadian Hypertension Society-Merck Frosst Canada research fellowship; and a grant from the Gardiner Foundation of Toronto.

Hospitals to participate in OPTIMIZE-HF

Hospitals across the country are being invited to enroll in a new hospital-based effort called OPTIMIZE-HF (Organized Program To Initiate life-saving treatment In hospitaliZEd patients with Heart Failure). OPTIMIZE-HF consists of a comprehensive heart failure patient database as well as tools and educational resources to help hospital staff better manage those patients. Unlike previous registry-based programs, OPTIMIZE-HF collects not only in-hospital data on patients but also focuses on pre-discharge planning and 60-to-90-day follow-up for certain patients. The program is designed to address the inconsistency between recommended guidelines for treating heart failure patients and current practices in most hospitals.

"Despite clinical trial evidence, national guidelines and educational conferences on managing and treating heart failure, a limited number of hospitals currently utilize comprehensive disease management programs," said Gregg Fonarow, MD, chairman of the OPTIMIZE-HF steering committee and associate professor of cardiology at UCLA Medical Center (Los Angeles, California). "As a result, many heart failure patients are discharged without guideline-recommended medications and patient education. For example, in-hospital initiation of ACE inhibitors and beta-blockers has proven to halt the progression of heart failure and save lives, yet many patients are not started on these therapies before discharge." OPTIMIZE-HF, he said, "can help identify barriers to treatment, improving outcomes for patients."

The OPTIMIZE-HF secure web-based registry evaluates the demographic, pathophysiologic, clinical, treatment and outcome characteristics of patients hospitalized with heart failure. Using the registry, hospitals can compile information on a patient's heart failure condition and required medications at the time of his/her admission, as well as recording hospital progress, providing real-time reports and benchmarks.

Another key feature of OPTIMIZE-HF is the Process of Care Improvement Program, a customizable hospital tool kit that includes a heart failure clinical pathway, admissions checklist, standard orders, chart stickers and discharge checklist, as well as a "Dear Doctor" letter, which informs a referring physician of a particular patient's hospitalization history and discharge medications. Participating hospitals also will receive patient education materials on the disease and heart failure medications, which will be available electronically and on CD-ROM so hospitals can easily access and print out specific materials for patients.

Through OPTIMIZE-HF, participating physicians have access to a resource guide, including reference information, ACC/AHA and HFSA treatment recommendations, peer-to-peer collaborations, structured educational opportunities and new published clinical trial data for patients with heart failure. In addition, hospitals can use the OPTIMIZE-HF program to track and transmit Joint Commission on Accreditation of Healthcare Organizations (JCAHO; Chicago, Illinois) core measures data, enabling them to meet the JCAHO core measure requirement for heart failure.

Hospitals participating in the program are compensated for each web-based case report form completed and submitted to the data management vendor, Outcome Sciences. OPTIMIZE-HF is managed by a steering committee, comprised of nationally recognized heart failure specialists throughout the country and sponsored by GlaxoSmithKline (London).

Fluvastatin use supported in new study

A new analysis of data from the landmark Lescol Intervention Prevention Study (LIPS) indicates that administering the cholesterol-lowering medication fluvastatin 80mg at time of first angioplasty reduced the risk of fatal and serious nonfatal cardiac events in high-risk patients with blockages in more than one artery by 34%, reducing their risk to the level of patients with only a single blocked artery. The findings were presented at the 52nd annual scientific sessions of the American College of Cardiology (Bethesda, Maryland) by researchers at the Erasmus Medical Center, University Hospital (Rotterdam, the Netherlands).

The four-year study followed 1,677 patients recruited from 57 centers in 10 countries. Major adverse cardiac events were defined as cardiac death, non-fatal heart attack, coronary artery bypass grafting, or repeat PCI.

"Overall, the LIPS data showed that beginning fluvastatin therapy after patients undergo their first percutaneous coronary intervention [PCI] procedure to open blocked coronary arteries helped prevent future cardiac events, including heart attacks and bypass surgery," said Patrick Serruys, MD, PhD, professor of interventional cardiology at Erasmus Medical Center and LIPS principal investigator. "The new analysis confirms the benefit of fluvastatin in this population whether patients had single or multi-vessel disease, balloon angioplasty or stenting, and regardless of their cholesterol levels."

Serruys continued: "These findings indicate that fluvastatin may also work by retarding the inflammatory and other processes that underlies the development of cardiovascular disease. They are absolutely consistent with the hypothesis that fluvastatin is acting on the disease process that causes the arteries to narrow, rather than only interfering with clot formation. And while the latter is important, the former is of far greater long-term significance."

In a separate analysis, researchers reported that fluvastatin therapy significantly reduced the subsequent MACE risk in patients who received either balloon angioplasty or stents compared to patients who received placebo. The fluvastatin balloon group experienced a significant 39% risk reduction, while the stent group saw their risk decline by 28%.