Highlights of the week:
EXACT Trial Launched; New Gene Therapy Option for Refractory Angina, CAD Patients
EXACT, a first-in-human clinical trial examining the safety and efficacy of using an adenoviral vector to more efficiently deliver human vascular endothelial growth factor (VEGF) directly into the myocardium with the goal of stimulating angiogenesis in patients suffering from refractory angina due to advanced coronary artery disease (CAD), has launched at Duke. Investigators on the trial include E. Magnus Ohman, Thomas Povsic (serving as site and national PI) and cardiothoracic surgeon Adam Williams.
The first treatment at Duke was performed by Williams on June 23.
“This is a very exciting time – this trial is the first of its kind,” said Williams. “It has the potential to change the landscape for patients with refractory angina by providing a new therapy that has the potential to stimulate the body to grow new blood vessels in the heart.”
Patients with refractory angina due to advanced CAD are often referred to as ‘no-option’ patients, according to Ohman.
When patients are first diagnosed with CAD, the treatment approach typically involves lifestyle changes along with medications and, as the disease progresses, interventions such as angioplasty or coronary artery bypass grafting can be performed to improve blood flow throughout the heart. As CAD becomes more severe, however, medications may not be as effective and patients eventually exhaust all options for revascularization. Patients with refractory angina due to CAD have typically had prior interventions to open vessels in the heart, but can continue to experience pain or pressure in their chest due to the diffuse nature of their disease. This is an experience that can be severely debilitating, occurring on a daily basis, significantly limiting their quality of life.
“At this point, Ohman says, “there are very few options and we have been working on trying to figure out more ways to help these patients. This trial represents a significant new option for them.”
Other EXACT trial sites enrolling patients are located in OH, MN, GA and FL.
“Treatments for patients such as these are desperately needed and this is a new option offered here at Duke that is not available elsewhere in this region,” says Povsic. “This option represents a novel approach from conventional revascularization or medical therapy, and aims to address the fundamental deficit of microvascular dysfunction and lack of blood flow to the myocardium.”
According to Williams, most gene therapy trials that have been done in humans use an adeno-associated virus, but EXACT is using an adenoviral vector to deliver VEGF directly into the myocardium. This is done, he says, through a very small, minimally invasive incision to reach the heart tissue. Under direct vision, the surgeon then injects areas of the heart muscle that are known to be ischemic with the goal of stimulating new blood vessel development in that area.
Adenovirus, Williams says, has a quick onset of action – it begins within a couple of days – and after a couple of weeks, it stops expressing the VEGF. The team expects it will take 1 to 2 months post-therapy to start seeing a noticeable difference in the heart tissue.
Importantly, the team will evaluate enrolled patients using positron emission tomography (PET) scans over the course of a year. The scans will provide critical objective data as to whether the intervention is leading to increased blood supply to the ischemic areas.
The team is happy to evaluate any patients who have ongoing angina (chest pain due to coronary artery disease) for inclusion in this or other potential trials. To learn more about the EXACT Trial criteria, please visit: https://clinicaltrials.gov/ct2/show/NCT04125732. To make a referral or discuss a possible patient with a member of the team, please contact the offices of either Dr. Povsic, 919-684-1284, or Dr. Ohman, 919-681-2069, or email Dr. Povsic directly at email@example.com.
Pokorney & Duke EP Enroll 1st Patient for Extravascular ICD Trial
Congratulations to electrophysiologist Sean Pokorney and the Duke EP team – they recently became an enrolling site for the Medtronic Extravascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study. Pokorney and team did their first implant of the investigational device on Monday, June 14th.
The clinical trial is designed to determine the safety and efficacy of using Medtronic’s investigational EV ICD system to treat patients who are at increased risk of dangerous ventricular rhythms – patients who are at increased risk for sudden cardiac death, who have an ejection fraction of 35 percent or less.
Traditional ICDs are implanted under the skin below the patient’s collarbone with electrode wires (“leads”) placed transvenously, meaning the wires are placed through a vein and into the heart, where they are attached directly into the heart muscle. The location of the leads directly inside blood vessels and heart tissue can increase the risk of blood stream infections in patients.
The EV ICD utilizes extravascular placement, meaning the leads are not placed inside the blood vessels, which eliminates the risk of blood stream infections. The device is the same size as traditional ICDs with a wire that is designed to be placed underneath the sternum and close to the heart without the need for transvenous positioning, according to Pokorney.
“This allows the device to both pace the heart and shock the heart out of ventricular tachycardia,” said Pokorney.
The EV ICD Pivotal Study is a worldwide clinical trial with 50 sites, 23 of which are based in the U.S. Duke is the only enrolling site between Washington, DC and Jacksonville, FL. To learn more about eligibility criteria, please visit: https://clinicaltrials.gov/ct2/show/NCT04060680.
Shout-out to Lindgren!
We received a recognition note this past week about Allison Lindgren, a cardiology PA on 7700. The note was sent to Rio Landa and Faith Williams by Katherine Adams, a clinical team lead for 7700, the cardiology stepdown unit at Duke University Hospital.
“Hi Rio & Faith, I wanted to take a moment to recognize Allison Lindgren. The nursing staff on 7700 submitted a recognition form for Allison for the quality care and team work that she provided from 6/21-6/23/2021. The staff members wrote this on the recognition form:
“Thank you for being someone who we can rely on. You are a great person to work with and we are so lucky to have you as a colleague”
Allison – thank you so much for all of your excellent work on the unit! We really appreciate you!” — Katherine
Way to go, Allison!
ICYMI: Duke Raleigh Hospital Opens New South Pavilion Bed Tower
Duke Raleigh Hospital celebrated the opening of its South Pavilion on Thursday, July 8, with move-in for patients expected to begin on Monday, July 12.
The nearly $196 million dollar project – which includes renovations to the hospital’s existing bed tower — is Duke Health’s largest investment in Wake County to date. The South Pavilion features 92 single-occupancy patient rooms, nine state-of-the-art operating suites and a new kitchen and café for patients and visitors.
“The newly completed South Pavilion adds space, not just for innovative care, but more room for families to be involved in the healing process during their stay,” said Leigh Bleecker, Duke Raleigh Hospital interim president. “This expansion brings us to 256 available beds in our facility — 186 licensed inpatient beds, plus 70 beds for observation and outpatient procedures. This total includes 28 ICU beds — an increase from the 15 we have today.”
The six-story South Pavilion compliments the hospital’s existing North Pavilion, which will be undergoing renovations in August to expand surgical areas, enhance the chapel and create a new corridor to link the two patient towers.
Construction on the new, 210,200-square-foot South Pavilion building began in 2018 and was designed to enhance patient and visitor experiences during their stays. Patient rooms include separate sitting areas for families, and new waiting rooms on inpatient floors overlooking Wake Forest Road.
Additionally, the new building incorporates art throughout, with a large, open lobby displaying work from local artists. The expanded café includes seating for nearly 200 guests and a menu featuring varied cuisines. An outdoor courtyard with dining areas, a tranquility garden and walking paths provides patients and visitors an opportunity to enjoy fresh air and sunshine.
With the new building and renovations in the North Pavilion, Duke Raleigh Hospital will have a new unified front entrance off Wake Forest Road in 2022.
“The building projects at Duke Raleigh Hospital – including construction of the South Pavilion bed tower and the upcoming renovations to the North Pavilion – represent the strength of our commitment to Wake County and the communities we serve,” said William Fulkerson, MD, executive vice president of Duke University Health System. “These projects are designed with careful attention to meeting the health and wellness needs of our patients, visitors and staff — both now and into the future.”
Have news to share?
If you have news to share with the Pulse readership, please contact Tracey Koepke, director of communications for Duke Heart at firstname.lastname@example.org. We would love to hear about your latest accomplishments, professional news, cool happenings, and any events or opportunities that may be of interest to our Duke Heart family. Please call with any questions: 919-681-2868. Feedback on Pulse is welcome and encouraged.
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July 8 — Derek Chew and Duke Clinical Research Institute
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