The Hospital of the University of Pennsylvania is home to one of the largest transcatheter valve programs in the United States. As part of its participation in the PARTNER I and II trials and trials since the commercial release of the Sapien transcatheter heart valve (Edwards Lifesciences), the program has implanted close to 400 Sapien (24F) and Sapien XT (18F) valves through transfemoral, transapical and transaortic access routes.
Howard C. Herrmann, MD, director of the interventional cardiology program and cardiac catheterization laboratories at the Hospital of the University of Pennsylvania, co-heads a multidisciplinary transcatheter aortic valve replacement team at the hospital that features specialists throughout many different areas. Among them include members from: the interventional cardiology program, Saif Anwaruddin, MD, and fellow Zachary M. Gertz, MD; the cardiac surgery program, Joseph E. Bavaria, MD (co-director), Wilson Szeto, MD, and Nimesh Desai, MD; the cath lab staff, Dawn Powers, Stephanie Pistone, Kevin Shallow and Robert Kelly; the OR staff, Tamara Clements, Esha Woodland, RN, and Bruce P. Landau; and the research staff, Lisa Walsh, RN, and Lauren DiBiase, MPH.
Dr. Herrmann supervising Dr. Gertz as he sets up the pressure manifold.
Currently, Drs. Herrmann and Bavaria and their team are involved in the PARTNER II cohort A trial, which will compare the Sapien XT valve with surgery in patients with severe, symptomatic aortic stenosis at elevated, but only intermediate, risk for surgery.
Although it is still relatively early on in the timeframe of PARTNER II, Cardiology Today Intervention got an inside look at one of the cases from the trial that showcased the multifaceted transcatheter approach in a 92-year-old female patient. Images by Frederick Keeney for Cardiology Today Intervention
The hybrid OR suite before the procedure. Multi-imaging modalities are used to determine optimal deployment of the valve.
Stephanie Pistone (left), cath lab technician, and Tamara Clements, OR scrub technician, work together in a multidisciplinary team approach to prepare the valve for implantation.
The Sapien XT 18F (23-mm) transcatheter heart valve.
Bruce P. Landau, radiology technician, sitting in the control room and helping to set up the monitors that will be used during the procedure.
“Not every hospital uses general anesthesia,” Dr. Herrmann said. “Some institutions, particularly in Europe, perform TAVR in a cath lab with conscious sedation, others in a cath lab with full general anesthesia, while others, including ours, utilize a hybrid OR with general anesthesia.”
(Pictured above and below) The transcatheter valve is manually crimped onto the balloon of the delivery catheter.
Before insertion of the valve into the sheath, the physician checks the valve orientation to make sure it is aligned appropriately so when implanted, the leaflets open correctly.
The valve is then inserted into and through the sheath, aligned in the aorta and positioned at the native aortic annulus. The balloon is inflated and the valve is expanded/deployed to its full diameter.
Femoral access is obtained.
Insertion of the sutures (ProGlide, Abbott)
at the beginning of the procedure.
The sheath is inserted.
The sutures are being tightened following the procedure.
The sheath is pulled out.
The final result.
Drs. Herrmann and Szeto working together to access the femoral artery and place the sutures.
All six screens of the monitor bank are displayed. From top left: a transesophageal echocardiogram image; the Paieon positioning software; the patient’s hemodynamics; From bottom left: live flouroscopy; a reference static flouroscopic image; Siemen’s syngo work station monitor.
The upper monitor shows the patient’s hemodynamics (BP in red, heart rate in green), while the lower monitor is the CT scan superimposed on live flouroscopy.
“This looked like a good position prior to rapid pacing and balloon deployment,” Dr. Herrmann said.
From left: Drs. Gertz, Anwaruddin and Herrmann and the cardiac surgeons (not in view) review the images obtained after valve deployment to confirm the result, assess any residual aortic regurgitation and decide on the need for additional balloon inflations.
“The patient did very well,” Dr. Herrmann later said. “She spent 1 day in the ICU and was discharged on post operative day number 8. She was doing very well at her 1 month follow-up visit.”