PHILADELPHIA INTERNATIONAL MEDICINE® NEWS BUREAU
Contact: Leonard N. Karp
215-575-3720
lkarp@philadelphiamedicine.com
February 26, 2007


For immediate release:
In this month’s edition:
  1. 46-Year-Old Man Receives First Temporary Total Artificial Heart in Northeast U.S. From Penn Cardiac Surgeons
  2. Fox Chase Cancer Center Offers Video-Assisted Thoracic Surgery for Some Lung Cancers
  3. Temple University Hospital Investigates Treatment for Cervical Dysplasia: A Potential Advance In Preventing Cervical Cancer

Editors note: Research, new techniques and improved facilities by Philadelphia International Medicine hospitals and physicians may lead to new ways to treat some of our most challenging diseases. Below are just some examples from our hospitals.

46-Year-Old Man Receives First Temporary Total Artificial Heart
in Northeast U.S. From Penn Cardiac Surgeons

Philadelphia — A 46-year-old former fitness instructor, suffering from biventricular end-stage heart failure and in irreversible cardiogenic shock, has become the first to receive a new temporary Total Artificial Heart in the Northeast U.S. by cardiac surgeons at the University of Pennsylvania Medical Center.

This lifesaving technology is used as a "bridge to transplant" for patients who are waiting for a donor human heart, who have both sides of their heart failing, do not respond to other treatments and are at imminent risk of death. Research has shown that patients receiving the device, called the temporary Total Artificial Heart (TAH-t) and manufactured by CardioWest ™ (SynCardia Systems, Inc.), have almost twice the survival rate versus patients who received standard ventricular assist devices.

Rohinton Morris, MD, surgical director, Heart Transplantation and Mechanical Assist Programs at Penn, and his team performed Penn’s first implant of a TAH-t on February 12, 2007, making Penn a certified transplant center for the new therapy. The patient, Ambler, PA resident, Gary Onufer, is said to be doing well following Monday’s six hour surgery. The TAH-t completely replaced his damaged heart, as opposed to just assisting it, while he waits for a donor heart to become available for transplant. Prior to the surgery, Onufer’s heart could no longer pump enough blood to sustain his body, damaging his vital organs.

Morris comments, "This unique new cardiac technology keeps the sickest of the sick – those with damage to their entire heart muscle -- alive while they wait for a heart transplant. This is just the latest addition to our already wide arsenal in battling the nation’s number one killer, heart disease. We at Penn are dedicated to pioneer and lead in the field of heart transplantation and mechanical assist devices."

The TAH-t is a modern version of the Jarvik-7 Artificial Heart that was implanted in patient Barney Clark in 1982. After ten years of study, the TAH-t is now the only total artificial heart approved by the U.S. Food and Drug Administration, Health Canada and Communite Europeenne for "bridge to transplant."

Michael Acker, MD, chief, Division of Cardiovascular Surgery at Penn, adds, "The TAH-t pumps up to 9.5 liters of blood per minute through both ventricles – making it the highest cardiac output of all mechanical circulatory support devices. This is truly lifesaving technology, implanted to do the work of a failing human heart until another one becomes available."

Penn joins a short, prestigious list of institutions worldwide -- becoming the first hospital in the region, and 15th in the world -- to complete TAH-t certification by performing a first proctored implant.


Fox Chase Cancer Center Offers Video-Assisted Thoracic Surgery for Some Lung Cancers

People with small lung cancers may benefit from a new use of an existing technology at Fox Chase Cancer Center called video-assisted thoracic (chest) surgery, or VATS. Similar to the minimally invasive laparoscopic surgery used for procedures in the abdomen, VATS uses small openings to gain access to the chest.

Surgery to remove a section or lobe of the lung is often a necessary and critical part of lung cancer treatment. Conventional or open surgery usually requires a six- to 10-inch incision, cutting the major muscles overlying the chest. The surgeon spreads the ribs apart with a retractor in order to view and gain access to the lung, sometimes even removing a portion of one rib. Following surgery, patients often stay in the hospital for a week followed by several weeks of recovery at home. A significant level of pain is typical with open surgery but can be greatly relieved with medication.

VATS is performed with two to four small incisions (the main incision is only two inches long). Instead of spreading the ribs and removing a piece of rib, the surgeon gains access to the lungs through a space between the ribs. By inserting a small camera, the surgeon has a magnified view of the organs on a monitor in the operating room.

"These patients do very well. They typically go home after two or three days, have less pain and recover much faster," explains Walter Scott, MD, a thoracic surgeon at Fox Chase Cancer Center.

Scott emphasizes that VATS allows the same comprehensive approach to removing the cancer as open surgery. "Removing all of the cancer is always our main goal, and VATS allows us to do that with less discomfort for the patient and a quicker recovery time."

Fox Chase is one of only a few institutions in the country offering VATS for some lung cancers. Scott says only about 3 percent of lung cancer surgeries use VATS.

"Minimally invasive surgical techniques have been used for many decades, but only recently have we applied the technology for treating patients with lung cancer," Scott says. "It’s a specialized area of medicine so choosing a highly-trained physician is critical.

"Because VATS can allow a quicker recovery, we expect this surgery will translate into better outcomes for patients."


Temple University Hospital Investigates Treatment for Cervical Dysplasia:
A Potential Advance In Preventing Cervical Cancer

Temple University Hospital’s Center For Women’s Health is participating in a national study to determine the safety and effectiveness of an investigational treatment for cervical dysplasia. According to the American Cancer Society, approximately 500,000 women are diagnosed with high-grade cervical dysplasia each year, with roughly 10,000 cases progressing to cervical cancer.

For numerous women afflicted with the common sexually transmitted disease known as human papillomavirus (HPV), the immune system can not prevent certain high-risk strains of the virus from causing cervical dysplasia, a common precursor to cervical cancer.

"The expected widespread availability of two preventive vaccines may lower the incidence of HPV infection and reduce the risk of cervical cancer," said Enrique Hernandez, MD, the Abraham Roth Professor and Chair of the Department of Obstetrics and Gynecology at Temple University Hospital and School of Medicine. "However, for those women already infected with HPV, and those who will become infected, there are emerging non-surgical options in development."

HPV vaccines are expected to be a significant advance in women’s healthcare, but they will not protect all women from cervical cancer. "Prophylactic vaccines will probably not help the more than 350,000 women in the U.S. already infected with HPV who have moderate to severe cervical dysplasia, a precancerous condition," explained Dr. Hernandez.

Amolimogene is an investigational immunotherapeutic from MGI PHARMA, Inc. that is currently being evaluated in a pivotal phase 2 clinical program in multiple centers in the U.S., including Philadelphia. "This product candidate is designed to enhance the body’s immune response to cervical dysplasia, and is being developed to offer patients with cervical dysplasia and healthcare providers an option to surgical intervention," explained Dr. Hernandez. "Qualified participants must be 25 or younger, with an abnormal Pap test result in the past six months."

According to Dr. Hernandez, HPV vaccines have shown protection against certain high-risk strains that cause approximately 55 percent of high-grade cervical dysplasia and 70 percent of cervical cancer cases. "The vaccines do not eliminate the risk of developing cervical cancer," said Dr. Hernandez. "They do not provide protection to women who are already infected with HPV, nor have they been shown to cure existing disease or lesions."

Every year, more than 3 million women have an abnormal result on a routine Pap test. Of these women, about 300,000-500,000 receive a diagnosis of moderate to severe cervical dysplasia, caused by certain high-risk HPV strains. "The prophylactic vaccines, which are highly effective in preventing the initial HPV infection, have not demonstrated effectiveness after the infection has progressed to cervical dysplasia," Dr. Hernandez explained. For women diagnosed with high-grade cervical dysplasia, the most widely utilized treatment option is surgery.

"The most common surgical procedure is LEEP (Loop Electrosurgical Excision Procedure), which removes the diseased part of the cervix," said Dr. Hernandez. "Although LEEP is effective, it may cause complications related to fertility and childbirth, such as cervical stenosis, pre-term delivery, low birthweight babies, and premature rupture of membranes."

Approximately 20 million people, mostly women, are currently infected with HPV, with 6.2 million new infections occurring annually, according to the Centers for Disease Control and Prevention. In a three-year study of college-aged women, 60 percent of subjects were infected with HPV. While the virus clears itself from the body in most women within two years, about a dozen high-risk strains can lead to more serious problems and are the main culprit for cervical cancer.