The Cleveland Clinic has released its third annual list of the 10 most significant medical developments of the last year. Management consultants Alix-Partners assisted with the selections, which were presented at the recent Innovation Summit.

Nominated innovations could be from any medical field or healthcare organization. The Clinic applied four criteria for qualifying and selecting innovations. For instance, a development had to have significant potential for short-term clinical impact (either a major improvement in patient benefit or healthcare delivery), a high probability of success, and be on the market or close to being introduced. Nearly 60 interviews generated a list of almost 100 nominations. A summary of the developments follow, but for a detailed booklet on the presentation from, go to: tinyurl.com/CCFTT2008

10. A common exchange standard for medical records.

Comprehensive electronic health records will link consumers, general practitioners, specialists, hospitals, pharmacies, nursing homes, and insurance companies. Primarily a private-sector effort, this computer standard could replace paper-based files. “We think the ideal model is the consumer-driven approach in which consumers control what information is gathered and stored at a central repository and who they choose to share it with,” says Joe Turk, Director of Information Technology at the Cleveland Clinic. One goal of the effort is to reduce the nearly $2 trillion annually spent on healthcare.

9. Noninvasive uterine artery occlusion for treating uterine fibroids

Uterine fibroids occur in upwards of 40% of women older than 35, triggering pelvic pain, pregnancy complications, and heavy bleeding. Although hysterectomy remains the most common treatment for fibroids, it is major surgery and does not preserve the uterus.

Doppler-guided uterine artery occlusion, an alternative to hysterectomy, works this way: The gynecological surgeon places a special clamp through the vagina. With Doppler-guidance provided by crystals at the tips of the clamp, the surgeon uses sound waves to locate the two uterine arteries and clamps them. This takes about 15 min. The clamp is removed after six hours, restoring blood flow to the uterus. However, while the clamp is in place, the fibroids are starved of nutrients and start to die. The uterus, however, can sustain itself while the artery is closed off. Eventually the excess fibroid tissue sloughs off and gets reabsorbed.

8. Using tractography to minimize damage to fiber tracts during brain surgery

Diffusion tensor imaging (DTI) has revealed fiber pathways that connect neurons in the brain. This lets neuroscientists noninvasively probe the long-neglected half of the brain called white matter. It is a densely packed collection of intertwining neurons that join the brain's four lobes, letting them communicate with each other. Results are presented in 2D and 3D color images, which are available at the time of surgery.

7. Simpler surgeries for nephrectomies, cystectomies, prostatectomies, and colon resections.

These endoscopic surgical procedures, more commonly called LESS (Laparoendoscopic single-site surgery) and NOTES (Natural orifice transluminal endoscopy) let doctors perform surgeries with minimal cutting and almost no scars. LESS, for instance, reduces the process to a small cut in the belly button. And NOTES bypasses normal laparoscopic incisions altogether. A surgeon gets to an appendix, prostate, kidney, or gallbladder through one of the body's natural cavities, usually the mouth or vagina. Pain is significantly reduced for both procedures, letting patients get back to daily activities sooner than previously possible.

6. A new way to make flu vaccines

This manufacturing approach uses a mock version of the virus called a virus-like particle (VLP). To create an avian flu VLP, scientists build a virus but omit genetic material required for replication. Researchers only need to know the genetic sequence of the virus to create a vaccine against it. The live virus is not needed. After injecting the VLP into a body, it attaches to cells and triggers an immune response sufficient to protect a person exposed to the virus. A recent study reports that an experimental VLP vaccine produced a response against H5N1 (avian flu) in up to 94% of patients.

Vaccines made this way are said to be easier to develop, produce, and manufacturer. “Once the WHO gets us the genetic sequence of the strain it thinks capable of pandemic, we can have a vaccine ready in 10 to 12 weeks, about half the time for egg-based vaccine production,” says Penny M. Heaton, a researcher involved in testing experimental VLPs for avian flu.

5. A clip repairs mitral-valve problems

The one-way mitral valve connects the heart's left atrium to the left ventricle. But if it regurgitates or leaks, the lungs swell with blood. The clip, a barbed, wishbone-shaped device now in its eighth year of human testing, repairs the heart nonsurgically from the inside out. A catheter is guided through the femoral vein in the groin, up to the heart's mitral valves. The clip, held on the tip of a catheter, is clamped on the center of the valve leaflets, which holds them together and quickly helps restore normal blood flow. By one estimate, 4 million Americans suffer from MVR and about 40,000 undergoing a highly invasive surgical repair.

4. Better image analysis for studying proteins

In the same way color images provide more information than black and white, multispectral imaging can tell researchers more about the properties in a tissue sample than a simple color camera. Such imaging let researchers resolve up to five or six chromogens in a single tissue section, even if those chromogens are spatially overlapping.

Attaching the imaging device to a standard microscope let's researchers stain up to four proteins using different colors and examine tissue samples with 10 to 30 different wavelengths, letting them gather more data. This helps researchers better understand signaling pathways in cancer cells and develop more targeted therapies.

3. A nerve stimulator lets patients breath without a mechanical ventilator.

An experimental diaphragm-pacing system could replace bulky ventilators. Anthony DiMarco developed the device along with his Case Western Reserve University colleague Raymond Onders. Generally, four electrodes are connected to the phrenic nerves on the patient's diaphragm by laparoscopic surgery. Electrical stimulation through these control the diaphragm, signaling when to contract and draw air into the lungs. With current off, the diaphragm relaxes and the patient exhales. In an early test, one patient was gradually weaned off his ventilator two weeks after surgery and learned to breathe with the stimulator.

2. A better way to preserve organs for transport

The current method for transporting donor organs places them in an ordinary picnic cooler and packs them with ice. Medics then have a 240-min. race to a recipient. Of course, as soon as blood flow stops, organs slowly begin decaying.

A better way to transport a variety of living organs, including the heart, is with the world's first warm-blood-perfusion carrier approved for use in Europe. The device is being tested in the U.S. “The carrier is actually a portable miniature heart-and-lung machine,” says Tomislav Mihaljevic, Staff Cardiac Surgeon at the Cleveland Clinic, and a member of the heart transplant team.

“Now after harvesting a heart, a liter of blood from the donor is also put into the device, which nearly duplicates conditions found inside a healthy body. The carrier then pumps warm blood through the heart which often naturally starts beating and keeps beating until the time it is transplanted,” he adds. In tests, hearts have kept beating for upwards of 12 hr in the enclosure.

1. Predicting the success of chemotherapy

It shocks and depresses patients when they receive news their cancer has recurred and spread, especially if they have been given a clean bill of health. A new way to measure circulating tumor cells (CTCs) in a blood sample detects rogue cancer cells early in patients with recurrent cancer. The test tells how well a therapy is working. It also lets patients monitor their progress at any point along their treatment and guide doctors in adjusting and customizing therapies.

“This blood test captures, identifies, and counts CTCs in sample,” says Daniel Hayes, Clinical Director of the Breast Oncology Program at the University of Michigan Comprehensive Cancer Center in Ann Arbor. “This gives us a snapshot of what cancer is doing at that moment without having to biopsy the patient.”