Research News at St. Francis Hospital

The CardioMEMS HF System

May 2019 

Heart Failure is a devastating condition, which may result in severe debilitation and death. Many heart conditions can cause heart failure. The most important strategy of preventing heart failure is to closely monitor the patient and rigorously manage the underlying heart condition. The CardioMEMS HF System is a monitoring system, which allows the doctor to evaluate the pressure inside patient’s heart wirelessly. Typically the pressure inside the heart goes up before patient develops HF. Clinical studies have shown that using this personalized approach to treating heart disease allows physicians to more proactively manage a patient's care while reducing the likelihood of heart failure related hospitalization. 

The CardioMEMS HF System contains a small pressure-sensing device that is implanted directly into the patient's pulmonary artery. While at home, patients lay on a special pillow to wirelessly take a pressure reading. Data from the sensor is collected through radio frequency to the pillow's antenna and then is sent wirelessly to the patient's doctor. This information can then be used by physicians to proactively adjust medications and treatment plans, if needed. 

Rita Jermyn, M.D. directs the CardioMEMS Program at St. Francis Hospital. She has implanted and followed over 300 patients with the device and is one of the leading implanters worldwide. Dr. Jermyn has authored numerous publications on CardioMEMS. 

The GUIDE HF study is a clinical trial, which will assess whether the CardioMEMS device can improve survival and quality of life for people living with heart failure mild or advanced. This trial is designed to build on the clinical experience gained from previous successful trial and aims to providing additional clinical evidence to further expand coverage for this first-of-its-kind technology. Dr. Jermyn is the leading investigator at St Francis Hospital for The GUIDE-HF trial. She has already enrolled a number of patients into this trial. To be considered for entry into this clinical trial, or if you’re a patient living with heart failure and want to be evaluated by our program please, contact the St Francis Heart Failure program at 516-562-6426. 

Heart Valve Symposium

By Kristin Pasquarello, MPAS, PA-C

Administrative Director, St. Francis Hospital Heart Valve Center 

On Saturday April 13, 2019 the staff of the John Brancaccio Heart Valve Center at St. Francis Hospital hosted the Second Annual Heart Valve Symposium at St. Francis Hospital's De Matteis Center in Greenvale, NY.  The sold-out Symposium hosted close to 200 attendees, which included physicians, advanced practice professionals, nurses and technologists. A variety of topics were discussed including the history of TAVR, cardiac imaging, Mitraclip, the St. Francis Heart Valve Center, which has been recognized as a Center of Excellence; as well as new innovative technologies such as transcatheter mitral and tricuspid valve replacements.  

Structural heart procedures such as TAVR, Mitraclip and TMVR were introduced as clinical trials at St Francis Hospital under the direction of Dr Petrossian and Robinson (TAVR/TMVR) and Dr Andrew Berke for Mitraclip who acted as Principal Investigators. The dedication of the Investigators and research team paved the way for FDA approval of these device and therapies to help treat patients with structural heart disease. 

Two live cases from the St. Francis Hospital Hybrid OR were performed and transmitted to the Symposium attendees. The live cases included a TMVR ( transcatheter mitral valve replacement) with an Edwards Sapien valve in a failed bioprosthetic mitral valve was performed by Drs. Petrossian and Robinson. The second live case, performed by Drs. Berke and Robinson involved a TAVR with a Medtronic Evolut valve in a 95 year old active man. This patient recently underwent a AAA repair at St. Francis Hospital prior to his TAVR procedure. The live stream to the DeMatteis Center was commentated by our expert panelists and moderators.  Both cases were a success and most importantly, the patients are doing GREAT! 

3D Printing comes to St. Francis

By Bill Schapiro, Manager, Cardiac MRI

Posted April 4, 2019

Over the last year the Research department has been developing 3D printing of the patient’s heart. Dr. Jane Cao, who directs the development of the 3D printing, believes that cardiac surgeons and interventionists can benefit greatly by holding the physical structure in their hands when planning a complex procedure.

To create a 3D model we take the data from a patient’s CAT scan or MRI and extract the structure of interest. We then convert this data into a special type of file that will tell the printer how to build the model. St. Francis uses a very advanced form of 3D printing called SLA or Stereolithographic. SLA uses a laser beam and special resin that hardens when the laser hits it. The print is created by adding layer after layer of hardened resin, much like a cat scan. Each layer is very thin, about 0.1 mm thick. There are many types of resins we can use, clear, flexible, elastic or ridge depending on the type of tissue we are trying to emulate.

The first several patient heart models that we printed were for Dr. Neil Bercow who operated on cases with complex ventricular aneurysms and coronary aneurysms. He commented after he compared the printed heart model and what he saw in the operation, “These models are 100% helpful in the surgical treatment of these complex cases”. In a recent project we printed a cardiac model for a case of hypertrophic cardiomyopathy to help Dr. Albert DiMeo with surgical planning for a myectomy, an operation to remove part of the thickened ventricular septum to relieve the obstruction of the heart. Dr. DiMeo said that “the model reproduced the area of thickened myocardium very precisely” allowing him a better understanding of the area to be treated. We have also printed atrial appendages for watchman device fitting for Dr. Joseph Levine, who is the first physician at St Francis Hospital to implant the Watchman device for patient with atrial fibrillation.

The 3D printing program at St. Francis Hospital is one of the few in the nation that is dedicated to the advancement of cardiac clinical care. The 3D printed patient heart provides exquisite details of complex anatomy allowing procedures to be performed with advanced planning and high precision.

Please feel free to contact Bill Schapiro, Manager of Cardiac MRI at 516-629-2099 to discuss your project, if you need 3D printing of the heart to assist with patient care.

Medtronic Low Risk Trial

By Joan Jennings RN MA, Research Nurse Specialist 

Posted April 1, 2019

Transcatheter Aortic Valve Replacement (TAVR) has developed into the standard of care for patients with severe aortic stenosis who are inoperable or at extreme or high risk for conventional surgical aortic valve replacement. St. Francis Hospital was a leader in the early Medtronic CoreValve clinical trials and was instrumental in gaining FDA approval for high risk populations.

In April 2016, St. Francis Hospital embarked on the Medtronic CoreValve Low Risk TAVR trial (EVOLUT) which is seeking expansion of the approved indication for patients who are at low risk for surgical aortic valve replacement (SAVR). In coordination with the John Brancaccio Heart Valve Center, the St. Francis Research team consented 53 patients for this randomized trial and 37 patients were deemed eligible to participate. Fifteen patients were randomized to SAVR and 22 received the CoreValve TAVR.

St. Francis Hospital continues to provide TAVR for patients with low surgical risk through the Medtronic CoreValve Low Risk TAVR Continued Access trial. Eight patients have received TAVR implant in this non-randomized protocol. Patients in both Low Risk studies will be followed for 10 years.

The results of the low risk Trials, both PARTNER 3 and EVOLUT were released at 2019 ACC held in New Orleans on March 16-18. TAVR for low risk patients with severe aortic stenosis is safe and effective. The death and stroke risks are at least comparable if not lower than surgery. The findings are now published in March issues of NEJM. Dr. Newell Robinson and Dr. George Petrossian were coauthors for EVOLUT trial.

“Our participation in the Medtronic Low Risk TAVR trial was an opportunity to be involved in research that will have a huge impact in how cardiology is practiced. TAVR was non inferior to surgical aortic valve replacement and TAVR will become the main form of therapy for aortic stenosis moving forward”, said George A. Petrossian, M.D., Co-Director of the Heart Valve Center.

“The results of the Low Risk Trials, both Medtronic and Edwards, were very provocative in that they suggest that a patient with any risk is a candidate for TAVR. This will likely change the way we treat aortic valve disease forever”, observed Newell B. Robinson, M.D., Chairman of Cardiothoracic Surgery and Co-Director of the Heart Valve Center.

“The opportunity to offer patients with aortic stenosis additional options for treatment has been extremely rewarding”, commented Patricia Krug, RN, CCRC, Research Nurse Specialist.

“Our experience at St. Francis with the early TAVR trials has given us a unique perspective on the evolution and advances of this technology that we can share with our patients”, observed Joan Jennings, RN, MA, Research Nurse Specialist.

GOING RED in Support of American Heart Association efforts with Women’s Heart Disease 

Posted March 1, 2019

Members of St Francis Hospital cardiac imaging, research and cardiology physician practice attended the American Heart Association’s Annual GO RED FOR WOMEN Luncheon, held at the Crest Hollow Country Club in Woodbury, NY on February 27, 2019. This event brings together female leaders from throughout Long Island to help fight against heart disease, heightening awareness, and empowering leaders to educate others about the movement. 

St. Francis Hosts Major Medical Conference on Cardiovascular Imaging

The fifth annual Intravascular Imaging and Coronary Physiology Workshop 2019 conference took place March 8th  and 9th at the Conrad New York. It was the biggest intravascular imaging conference to date, attracting close to 400 attendees as well as world-renowned faculty from around the globe.  Under the direction of Dr. Richard Shlofmitz, Chairman of Cardiology at St. Francis, attendees learned about state-of-the-art intracoronary image interpretation using optic coherence tomography and intravascular ultrasound, best practice for coronary physiology, the algorithm of precision PCI, and newer techniques and emerging research evidence in the field of coronary imaging and physiology. The highlight was two Live Cases telecast from the Cath Lab at St. Francis Hospital, where attendees could witness coronary interventions and ask questions of the physicians performing. 

Lithotripsy: the newest innovation to treat the heart vessel blockage

By Susan V. Thomas, Research Associate

Posted February 27, 2019

St. Francis Hospital, The Heart Center has become the first hospital in the U.S. to enroll patients for the landmark study Disrupt CAD III, using an innovative and minimally invasive Intravascular Lithotripsy (IVL) system to break up calcified lesions for those needing stents.  The Disrupt CAD III study will enroll approximately 400 patients at 50 centers worldwide and is designed to assess the safety and effectiveness of the IVL system which is considered investigational in the U.S.  #WarOnCalcium

A Conversation with the PI

We had the opportunity to talk to Dr. Richard Shlofmitz on calcium and its effect on coronary artery disease (CAD). He did not shy away from emphasizing the pivotal role intravascular imaging plays in identifying the varying morphology of calcified   lesions. For severely calcified lesions (deep calcium, with an arc greater than 180° and 5 mm of length), it is difficult to open these lesion areas with just angioplasty or stenting. Not properly breaking the calcium prior to stenting can cause restenosis (closed stents) and not have the same luminal gain as expected.

How does IVL technology work?

Dr. Shlofmitz: You cross the lesion, place the IVL balloon in the area of calcium based on imaging, go to 4 atmospheres. Once you activate the shock wave, the balloon opens up completely after the calcium is fractured and becomes more compliant. There’s no set number of shock wave pulses but you can give about 20-40 pulses and see how the lesion responds to the waves. Intravascular imaging is done before and after the shock waves and after stenting. Not only is this technology providing a clinical need for fracturing deep calcium lesions, but it provides an easy-to-use workhorse wire technique that physicians are comfortable with, allowing for better control, positioning, and safety. The lithotripsy unit is delivered from inside the balloon, which is easy for any physician to use.

St. Francis Hospital is the first U.S. site to enroll into the clinical trial Disrupt CAD III. What made this study interesting to you?

Dr. Shlofmitz: St. Francis was approached to be the first site in the U.S to use Intravascular Lithotripsy (IVL) for coronary disease through Disrupt CAD III and we accepted the opportunity. We have the expertise and largest volume of intravascular imaging, especially through Optical Coherence Tomography (OCT), cardiologists with leadership in OCT based studies as well as tremendous experience in orbital atherectomy (for calcium modification). We also have great research staff and interventional cardiologists eager to improve patient outcomes through research, which makes the study an exciting opportunity.