Those who have a family member or friend being treated at the new Oklahoma Heart Hospital (Oklahoma City, Oklahoma) don't have to remain penned in at the hospital's waiting room for fear of missing a patient update. The coaster pagers – like those given out at a busy restaurant – blink and buzz when there is new information about the patient. And patients wearing heart monitors don't have to stay in their rooms to guarantee constant surveillance and monitoring if the wrong thing should happen. They can wander the halls, or spend time in the cafeteria with family since ceiling-mounted antennas pick up the signals from their monitors and send them to nursing stations. The coaster pagers underline the facility's "hospital-to-hospitality" trend, and the distance monitoring demonstrates the hospital's emphasis on patient mobility.

Opened this past spring, the Oklahoma Heart Hospital bills itself as "all-digital" and features the newest paperless and filmless systems and mobile communications. Its developers consider it the most advanced such cardiovascular facility in the state, and perhaps in the entire nation. "We feel that we're pioneers here," Mike Schroyer, president of the hospital, told Cardiovascular Device Update during a recent visit. "We have been told by various vendors that we are the first trying to integrate everything into one electronic medical record – and not just in this state." He adds: "As pioneers, we're working out a lot of issues that people from here on will benefit from."

Completed at a cost of $75 million, the new three-story, 204,000-square-foot facility is a joint venture of Oklahoma Cardiovascular Associates (also Oklahoma City), the largest group of cardiovascular physicians in the state, and Mercy Health Center. Its mission: to take serious aim at Oklahoma's above-average rates of cardiovascular disease and the need for better care in rural areas.

The hospital contains five cardiac and peripheral vascular catheterization labs, four open heart/ peripheral vascular surgical suites, a heart emergency room and the associated care units. Besides offering a range of services, it specifically was designed to be more patient-friendly, integrating that approach with a variety of advanced digital technologies and systems.

The most obvious signs of the facility's digital emphasis are PCs in every patient room, which the doctors use to call up patient records or any scans and images taken in the hospital. These can then be reviewed with the patient and family at the bedside. Schroyer says all of the systems are designed "to put the patient first. In everything we do, we ask, 'How does this affect the patient?'"

That patient-centered strategy also is seen in a 1-to-4 maximum nurse-to-patient ratio, a critical path time of just 45 minutes from emergency room to cath lab to OR, and patient rooms that double as critical care rooms to reduce the stress caused by the patient moves usually required in cardiovascular facilities. Even individualized meal requests – including the patient's preferred mail times – are sent by computer to the kitchen, Schroyer noted, as part of computer scheduling for the patient's day.

Keith Minard, acting chief information officer, said there is "a lot of emphasis on mobility" throughout the hospital. Thus, doctors carry Compaq (Houston, Texas) iPaq organizers to make notes whether in the hallways or a patient's room. And a PBX system drives a network of cordless phones carried by nurses, allowing them to "take a patient call while in another room" or perhaps respond quickly to a Code Blue, Minard said.

The backbone of the hospital's systems comes from Cerner (Kansas City, Missouri), Minard said, with other technologies selected from a variety of vendors. "When you come to the medical world, each company makes best of breed for something," Minard said. The very best of these systems were then chosen and "mixed – cut and paste," he said, to serve the hospital workers and patients "from edge to core."

Schroyer said that the digital emphasis was possible largely because of building new rather than adding on to an existing facility and that the ground-up approach enables future integration of even more advanced systems. Once working smoothly, the hospital "will do time studies focused on patient care" and look at outcomes "in regards to the benefits for patient and family education," he said.

Oklahoma Heart Hospital has become the cardiovascular center for adjacent Mercy Hospital. And officials frequently said they hope it will serve as a showcase for other facilities to come, both nationally and worldwide, not just a standard for heart care in Oklahoma alone.

Minard, as the one heading up installation and implementation, said the hospital's technology "is not what you see – it's subtle here." He emphasized that the physicians who pushed the hospital's digital emphasis wanted technology not just for its own sake but for what would be most usable in patient care. He added: "The doctors have been aggressive in using the technology. They want to use it faster than we can deliver it."

AbioCor trial draws liability suit

The widow of James Quinn, one of seven patients in the trial of the AbioCor replacement heart made by Abiomed (Danvers, Massachusetts), last month filed suit against the company and Hahnemann University Hospital (Philadelphia, Pennsylvania), where Quinn was implanted, and also against the patient advocate assigned to help Quinn make a decision to join the trial. Quinn died Aug. 26, at 52, after suffering a stroke. The suit charges improper design of the trial and extreme pain and suffering experienced by Quinn and his wife as a result. Quinn's death left only one person remaining alive in the trial, Tom Christerson, who continues supported by the AbioCor for about 14 months and has been living at home in Central City, Kentucky, since April.

Alan Milstein, the attorney representing the widow of James Quinn in the suit, said that he does not expect that the suit will block continuation of the trial or the eventual development of an artificial heart. "Society has to get to a point where we can have an artificial heart," Milstein told CDU. The issue, he said is developing such a device "without taking away the dignity of [trial] subjects. It's a difficult thing to do." He went on: "It didn't work with [Quinn]. It just wasn't what he expected or his wife expected when they signed on to this."

Milstein said that a primary issue in the trial, if one occurs, is informed consent by the patient and "whether all the information was properly conveyed" to Quinn. And in this case, because of the particular nature of the study, is whether a person told he has limited time to live can give such consent. Milstein said Quinn is one of "a vulnerable population in the context of bioethics – there's no question that anyone told they have a week to live is in a vulnerable state." But, he went on, "That's not to say it's impossible to get informed consent from someone in that situation. There are certain circumstances where that's possible. It just didn't happen here."

Milstein said that Abiomed had clearly learned from the experience of Barney Clarke, one of the first people to be implanted with an artificial heart, the Jarvik 7, nearly 20 years ago. Abiomed, he said, "sought to address some of the problems" in that case but "obviously, not all of those problems." In particular, he said that a critical point was "the end game, so to speak – what happens when the patient lives more than 62 days? And what happens when the patient lives even longer?"

The complaint charges that Quinn and his family were not properly informed concerning the potential pain and suffering that he might experience and that "there were limited benefits to him as a subject." It goes on to say that that the artificial heart was presented to him as a "therapeutic alternative" and that various promises were made to him concerning his care that were not fulfilled. The suit also alleges that the Quinns were not informed of "the interests [of the hospital] in relation to the study."

Repeating his view that the suit will not impede progress of the AbioCor trial, Milstein said, "The only way it will effect the Abiomed trial is to ensure it will be done ethically – that's all we can ask as a society." He added: "Abiomed will be able to conduct the trial and one day we'll have an artificial heart."

News of the lawsuit came on the heels of an Abiomed conference call in which company officials reviewed what they called exceptional mechanical performance by the AbioCor. The company said that the trial's "positives clearly outweigh negatives" and that it remained optimistic about the trial's future. "Increasing efforts," it said, "are being made to enroll additional patients into the clinical trial." And it repeated its general policy of attempting to enroll "the sickest of patients," while increasingly targeting patients with fewer non-cardiac complications.

Endovasc creates drug subsidiaries

Endovasc (Montgomery, Texas) last month launched two subsidiaries: Liprostin Development, for its anti-inflammatory cardiovascular drug Liprostin, and Angiogenix Development for its nicotinic acetylcholine receptor agonist drug, Angiogenix. "We're putting each of the technologies into a separate entity that will be owned by either the shareholders or the company," said Dwight Cantrell, company CFO. "By doing this, we have an entity out there that just has [a single technology] in it. That makes the deal structuring much easier."

Angiogenix and Liprostin have received FDA clearance to enter Phase III trials. Angiogenix is a nicotine-based drug designed to grow new blood vessels and promote angiogenesis and subsequent renewal of heart function. In recent studies, test animals actually grew new blood vessels in their heart after blood flow was constricted to produce a condition modeling chronic myocardial ischemia. Liprostin is a liposomal prostaglandin-based treatment designed to provide significant relief for people suffering from poor circulation due to arterial blockages, lack of blood to muscle tissues and heal intractable wounds.

Cantrell said future spin-offs would result from products deeper in Endovasc's pipeline. "Endovasc is the pipeline," he said. "[It] will be the one that generates the ideas, but the other companies will be the ones that other technologies eventually move into." Any funding received by the Angiogenix and Liprostin would not dilute Endovasc stock, nor would it create debt for the parent company. In the future, Endovasc shareholders would receive a distribution of stock, subject to the customary regulatory approvals and the filing of the necessary registration statement.