clinical update publication

Patients Benefit from Nobel Prize-Winning Therapy
Many patients with severe congestive heart failure and left ventricular dysfunction develop pulmonary hypertension. The use of common treatment agents, such as inotropes and intravenous vasodilatory agents, can create significant limitations that include side effects and diffuse pulmonary vasodilatation, which results in worsening ventilation/perfusion mismatch and compromises the respiratory component of the patient as in hypoxemia/Adult Respiratory Distress Syndrome (ARDS) conditions.

patient in respiratory distress

"Evidence from FDA-approved clinical studies has shown that Nitric Oxide (NO) can be very useful in lowering pulmonary artery pressure by decreasing the vascular resistance flow through the lungs," said Michael Neary, M.D., Director of Surgical Intensive Care Unit/Associate Medical Director of Respiratory Care Department, Deborah Heart and Lung Center. "The application of inhaled NO for the treatment of primary pulmonary hypertension and respiratory failure is an important development in critical care."

Recent discoveries concerning NO led to the 1998 Nobel Prize in Physiology or Medicine for three American researchers who found that the body's own NO acts as a signal, telling blood vessels to dilate. Inhaled NO is a potent pulmonary vasodilator because it is selective in its actions on the pulmonary vasculature due to its rapid inactivation as it binds to hemoglobin after crossing the alveolar epithelium, according to Dr. Neary.

"NO is the only known drug that physicians can use to selectively influence the tone of pulmonary vessels," said Dr. Neary. "Unlike other vessel-dilating drugs that act first upon the systemic circuit and then upon the pulmonary circuit, inhaled NO reaches the pulmonary circuit first and is then rendered inactive before it can reach the rest of the body."

FDA-approved clinical investigations of NO have been ongoing at Deborah and are performed under strict research protocols. The protocols detail investigations for NO in both pediatric and adult populations.

The pediatric study focuses on those with increased pulmonary vascular resistance (PVR) due to congenital heart disease (pre- and post-operative), primary pulmonary hypertension, persistent fetal circulation and cardiomyopathy.

"Increased PVR is a serious risk factor for morbidity and mortality following surgery for heart disease in children because of the stress caused by anesthesia, the heart/lung machine and surgery itself," said Niels G. Giddins, M.D., Chair, Pediatric Cardiology, Deborah Heart and Lung Center. "The introduction of inhaled NO helps lower an increased PVR in the pediatric patient without affecting the normal blood pressure in the systemic pulmonary vessels."

The adult protocol targets patients with Primary Pulmonary Hypertension and ARDS. As in the pediatric protocol, the selective effect of NO lowers pulmonary hypertension without producing systemic side effects. "In our target population, there is significant potential benefit to decreasing PVR and therefore improving morbidity and mortality in an at-risk population" said Dr. Neary.

In both patient populations, NO is administered through the OHMEDA INOvent Delivery System, which works through the existing ventilation equipment. The INOvent mixes and monitors levels of gases administered to the patient. Periodic blood samples are drawn to ensure that patients do not develop toxic levels of NO or its by-products.

"NO delivery is initiated at 5 parts per million (ppm), then 10 ppm and increased by 10 ppm every 10 minutes to determine dose of efficacy or maximum dose of 80 ppm," according to John Hill, RRT, Technical Director, Respiratory Care Services, Deborah Heart and Lung Center. "A dose is considered effective if it results in decreasing the measured/estimated pulmonary artery pressure less than or equal to 15 percent or increasing the arterial pO2 less than or equal to 15 percent."

If no clinical efficacy is achieved, the drug is discontinued. Once an effective dose is reached, that dosage is sustained. Patients who receive NO therapy for a period over 24-hours are weaned from the drug under physician supervision to prevent clinical deterioration. If deterioration does occur, according to Hill, NO is re-instituted at 50 percent the prior dose.

"There is no more than a minimal risk to patients in the studies," said Dr. Neary. "Protective measures are built into the INOvent system and periodic blood samples check for levels of NO by-products, such as nitrogen dioxide."

"The benefits of NO therapy are substantial," continued Dr. Neary. "Patients with PVR can now be treated without affecting systemic pressure. This greatly increases a patient's recovery rate following cardiac surgery."

Michael Neary, MD., Director, Surgical Intensive Care Unit
Associate Medical Director, Respiratory Care Unit

Deborah Offers Pulmonary Program for Asthmatics

Deborah's "Attention Asthma Program," addresses the need for specialized treatment of severe asthmatics. "Individuals completing the program will have gained the ability to effectively reduce the frequency of asthma symptoms," said David M. F. Murphy, M.D., Chairman of the Department of Pulmonary Medicine at Deborah.

The program combines extensive diagnostics, thorough evaluations, intensive patient education, individual counseling and written treatment guidelines. The goal of the program is to decrease chronic asthma symptoms and frequency of attacks. Potential benefits are increased well-being of the participants and decreased future healthcare costs.

The multi-dimensional program is comprised of a specialized team which includes: a pulmonologist; a pulmonary nurse practitioner; a pharmacist; a psycho-social nurse counselor; a pulmonary laboratory technician; a respiratory therapist; a dietitian and an exercise physiologist. Program participants will be provided with on-site housing if needed and complimentary meals for the three days of the program.

"One major advantage of this program is the ability to completely focus the patient's attention on their disease and its management," said Dr. Murphy. "We are committed to addressing the growing need for asthma care in our community. By preparing asthmatics to control their condition, greater control and better quality of life will be achieved."

For more information on Deborah's Attention Asthma Program or to refer a patient, call (609) 735-2919

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