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DAIC Thought Leadership Series: The Importance of Inclusion in Clinical Trials

As part of DAIC's continuing Thought Leadership Series, this month Editorial Director Melinda Taschetta-Millane sits down with Philip B. Adamson, MD, MSc, FACC, Chief Medical Officer of CVRx, to talk about health equity — starting at the beginning of clinical trials, and including how medical device manufacturers need a clear roadmap from the get-go to achieve success.

As Chief Medical Officer of CVRx, Dr. Adamson will spearhead efforts to drive awareness and appropriate use of Barostim therapy among clinicians. He will guide comprehensive medical education, outreach and guideline integration initiatives to establish Barostim as the standard of care for patients with heart failure. Dr. Adamson previously was with Abbott Laboratories, where he served as Divisional Vice President and Chief Medical Officer of the Heart Failure division. A renowned expert in heart failure, he has nearly three decades of experience in academia as a professor and as a practicing cardiologist, during which time he authored over 150 manuscripts and book chapters. Dr. Adamson earned his MD with distinction from the University of Oklahoma College of Medicine and MSc in physiology from the University of Oklahoma.

His clinical interests focus on developing more efficient and effective disease management systems for patients with chronic heart failure, specifically focusing on remote monitoring of physiologic signals from implanted devices. He has also served as the principal investigator on the steering committees of several large randomized clinical trials over the past decade.

Related content:

DAIC Thought Leadership Series: Practical Realities of Artificial Intelligence in Echocardiology

DAIC Thought Leadership Series: Collaboration Challenges in Complex Cardiology Settings

 

Recent Video

Resuscitation Devices | August 01, 2011

Paramedics in Bellingham, Wash., used the Lucas device on patient Nancy Olson, who went into cardiac arrest following a heart attack. The device provided chest compressions while she was enroute to the hospital, helping to perfuse her brain and other organs, prior to her undergoing emergency percutaneous coronery intervention (PCI). For more information on the Lucas, visit www.physio-control.com.

PET-MRI | June 27, 2011

Three companies showed different versions of a combined positron emission tomography (PET)-magnetic resonance (MR) (PET-MRI) system during the Society of Nuclear Medicine (SNM) 2011 annual meeting. Representatives from Siemens, Philips and GE Healthcare explain how their systems work and how PET-MR may be used as a new modality to show both physiologic and anatomical information.

Each company took a different approach to how they create PET-MRI images. Siemens integrated both modalities into one gantry. Philips uses two gantries with a table that moves between the two that maintains patient alignment for fusion imaging. GE Healthcare uses a cot that can move between the MR and PET rooms and fits both systems to maintain alignment and does not require buying a new decicated scanner. 

 

Nuclear Imaging | June 27, 2011

Society of Nuclear Medicine (SNM) President George Segall, M.D., chief of the nuclear medicine service at the VA Palo Alto Health Care System, and is a professor of radiology and professor of cardiology (by courtesy) at Stanford University School of Medicine, offers insights into the trends he saw at the society's 2011 annual meeting.

Trends in nuclear imaging include the creation of PET/MRI systems, use of time of flight (TOF) imaging, new technqiues to image amyloid plaque in Alzheimer's Disease, and the movement toward multimodlaity imaging rather than radiologists specializing in justy one modality.

More nuclear medicine news and video 

Cardiovascular Information Systems (CVIS) | May 16, 2011

This podcast explains how syngo Dynamics can be used to integrate cardiac imaging picture archiving and communication (PACS) and cardiology reporting systems into one platform.

Heart Valve Technology | April 28, 2011

Death rates are similar at one year for a catheter-based aortic valve replacement procedure and conventional surgery in older high-risk patients, explains Michael Mack, M.D., in this interview with DAIC Editor Dave Fornell. Mack is the medical director of cardiothoracic surgery for Baylor Scott and White Health and the chairman of BSW The Heart Hospital – Plano Research Center. He said the results from Cohort A of the PARTNER trial found that survival of patients treated with the Edwards Sapien transcatheter aortic valve was equivalent to those treated with surgical aortic valve replacement in the head-to-head comparison. The data were presented at the American College of Cardiology's (ACC) 2011 Scientific Session in New Orleans.

Death rates are similar at one year for a catheter-based aortic valve replacement procedure and conventional surgery in older high-risk patients. Results from Cohort A of the PARTNER trial found that survival of patients treated with the Edwards Sapien transcatheter aortic valve was equivalent to those treated with surgical aortic valve replacement in the head-to-head comparison.

Read the article Transcatheter Valve Equals Surgical Outcomes at One Year
 

 

 

Radial Access | April 28, 2011

The RIVAL Trial, the largest randomized trial to compare radial access and femoral access for coronary angiography and intervention, researchers found radial access reduced rates of vascular complications, according to research presented at the American College of Cardiology (ACC) 2011 Scientific Session in New Orleans.[1] The trial also found that radial access did not reduce the primary outcome measure of death, heart attack, stroke and non-CABG-related major bleeding compared to femoral access in the overall study population. The data showed these outcomes were equal for both femoral and radial access procedures.

"Interventional cardiologists can feel reassured both radial and femoral approaches are safe and effective," said Sanjit Jolly, M.D., M.Sc., assistant professor of medicine at McMaster University in Hamilton, Ontario, Canada. Radial access did lead to reductions in the primary outcome measure in patients who underwent the procedure at hospitals that conducted a high volume of radial procedures. For centers that were less experienced with radial access, Jolly said it was clear there is a learning curve, and operators got better and faster with radial procedures with more experience. "The take-home message is practice makes perfect," he said. Jolly explained the high-volume centers using radial access performed very well, but it was clear from the study operators need a lot of radial cases to increase performance.

Read the article RIVAL Trial: Radial Access Reduces Vascular Complications
 

Reference:

1.    Jolly SS, Yusuf S, Cairns J, Kari Niemelä DX, Petr Widimsky, Andrzej Budaj, Matti Niemelä, Vicent Valentin, Basil S Lewis,, Alvaro Avezum PGS, Sunil V Rao, Peggy Gao, Rizwan Afzal, Campbell D Joyner, Susan Chrolavicius, Shamir R Mehta, for the group. “Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial.” Lancet 2011. DOI:https://doi.org/10.1016/S0140-6736(11)60404-2

April 28, 2011

www.Womenheart.org‎ is the only national organization dedicated to promoting women's heart health through advocacy, education and patient support. As the leading voice for the 42 million American women living with or at risk of heart disease, WomenHeart advocates for equal access to quality care and provides information and resources to help women take charge of their heart health. Lise Tate, CAE, CEO of WomenHeart, the National Coalition for Women With Heart Disease, said the non-profit group helps set up hospital support groups to guide women through their treatment and recovery. Since its inception, WomenHeart — founded by three women heart attack survivors who transformed the isolation, confusion and ignorance about women's heart disease into a rallying call to save women's lives — has been at the forefront of providing support services to women with heart disease and educating policymakers, health professionals and the public about the urgent need to make women's heart health a priority.

Founded in 1999, WomenHeart's mission is to improve the health and quality of life of women living with or at risk of heart disease. Through our programs and services, WomenHeart raises awareness about the importance of prevention and early detection, accurate diagnosis and proper treatment of women's heart disease. WomenHeart is a coalition and a community of thousands of members nationwide, including women heart patients and their families, physicians, health advocates and consumers committed to helping women live longer, healthier lives. At the center of the organization are the more than 500 WomenHeart Champions, all heart disease survivors, who have graduated from WomenHeart's Science and Leadership Symposium at the Mayo Clinic. These alumnae serve as WomenHeart local support group leaders, community educators, media spokeswomen, and general support volunteers. Through leadership and advocacy training, information resources and an online community, WomenHeart empowers women living with heart disease to manage their own heart health and to help all women take charge of their heart health.

For more information: www.womenheart.org

Radial Access | March 22, 2011

Radial access is very popular outside the United States because it offers improved safety, comfort and cost savings over femoral access, which is the current U.S. standard of care. Femoral access site recovery usually involves heavy, uncomfortable compression of the leg. Patients are also required to lay on their back, in bed and not move for hours to ensure proper hemostasis. These discomforts are eliminated with radial access. Most importantly, the risk of bleeding and arterial damage, the most common complications following these procedures, is essentially eliminated with the transradial approach, said Jack P. Chen, M.D., FACC, FSCAI, FCCP, director of cardiac research, St. Joseph's Translational Research Institute, Saint Joseph's Heart and Vascular Institute, Atlanta. He also directs a course to train cardiologists on the transradial technique. "If you talk to any patient who has gone through a transfemoral procedure, they will tell you the worst thing is after the procedure. That's what patients dread the most."

"Most patients complain of the bed rest, the back pain, muscle spasms and the tremendous amount of pressure applied to their groin by a clamp or a staff member. You can spend three hours performing a complex, multidevice, multivessel bifurcation rotablator/stent case with an excellent result, but what the patient will remember is the pain from the pseudoaneurysm repair they now need," Chen explained.

Radial access eliminates this vascular access risk, as well as the pain and discomfort associated with hours of bed rest, Chen said. "There is no question patients prefer this," Chen explained. With patients who have undergone both radial and femoral access procedures, Chen said the vast majority will never let him touch their legs again. This type of patient satisfaction has spread by word of mouth and has led to an increasing number of patients seeking radial access procedures at St. Joseph's. "My patients are the procedure's and my best advocates," Chen said.

In March 2010, St. Joseph's Hospital of Atlanta opened the first transradial access recover lounge in the United States. It replaces beds with chairs and patients are encouraged to walk around, get coffee, check their e-mail and read.

Radial Access | March 22, 2011

St. Joseph's Hospital of Atlanta created a radial access recover room that replaces beds and the sterile institutional hospital look with a more patient-friendly design. Transradial access is slowly gaining ground in the United States as more physicians make the switch due to greatly reduced bleeding complications, increased patient comfort and earlier ambulation. St. Joseph's Hospital of Atlanta is a big supporter of radial access and has taken the concept a step further by creating the first transradial recovery lounge in the country.

"I really see this as the future of cardiac care, not just as an alternative access route for percutaneous coronary intervention, but also to improve the patient experience and reduce their hospital stay," said Jack P. Chen, M.D., FACC, FSCAI, FCCP, director of cardiac research, St. Joseph's Translational Research Institute, Saint Joseph's Heart and Vascular Institute, Atlanta. A trend in medical facility design over the past 15 years has moved away from the sterile, institutional look of traditional hospitals. Instead, more inviting, warm and friendly looking facilities are being built to make patients feel more comfortable. This concept is now being applied to the cath lab recovery room. Use of radial access allows for immediate ambulation, and thus a major revision to recovery room design, replacing beds with couches and recliner chairs. St. Joseph's Hospital is the first in the United States to build a cafe-like lounge exclusively for radial access patients.

Chen took the idea from Ferdinand Kiemeneij, M.D., department of interventional cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands. He created the first radial access recovery room in Europe after getting the idea from a KLM airline lounge. "The idea is to build a cafe-type atmosphere to reduce the anxiety associated with invasive heart procedures," Chen said. "When I first approached the hospital administration with this idea, they required a bit of convincing. However, after seeing the patient satisfaction and alleviation of complications stemming from this technique, all were in agreement that this concept may well be the wave of the future."

Watch a VIDEO interview with Kiemeneij on the history of radial access. 

He said the hospital embraces the radial access approach as a new frontier in interventional cardiology and agreed to build the new recovery area. "To me, this rounded out the picture of a more patient-friendly cardiology program for what is essentially a minimally invasive catheterization/interventional procedure," Chen said. Patients sit in the lounge chairs for 30 minutes to an hour, only to recover from the sedation. The patients are then allowed to ambulate in their street clothes. They can walk around or sip a cappuccino, Chen said.

The recovery room has comfortable reclining chairs instead of beds and there are couches and coffee tables topped with magazines and newspapers. The recliners have attached swing-up tabletops where patients can put a laptop computer and check their e-mail or surf the Internet. The idea is to eliminate the sterile, institutional appearance of most recovery rooms and to relax the patient with a more inviting atmosphere. â??We are trying to take the hospital out of the equation," Chen said. "Patients are much more at ease than they would be in a typical hospital setting. To allow them to put their street clothes on really reduces the anxiety they have." The lounge was showcased and visited by many cardiologists from around the country during the American College of Cardiology (ACC) Annual Scientific Sessions in March 2010, which were held in Atlanta.

March 22, 2011

Michael Ringold, M.D., interventional radiologist, St. Luke's Hospital and Health Network, Bethlehem, Pa., explains how GEâ??s Innova system is used to perform embolization of hepatic tumors.

March 22, 2011

Using GEâ??s Innova imaging system for central venous access and hemodialysis fistula management, Innova provides flexible access to the patient. Presented by Kenneth Chin, M.D., FACR, San Fernando Valley Interventional Radiology and Imaging Center, Encino, Calif.

March 22, 2011

Musculoskeletal injuries are of concern to many interventional radiologists due to the constant positioning, twisting and turning to see the fluoro monitors. Kenneth Chin, M.D., of the San Fernando Valley Interventional Radiology and Imaging Center, explains how GEâ??s Innova imaging system helps to avoid these injuries.

March 22, 2011

Prashant Patel, M.D., St. Luke's Hospital and Health Network, Bethleham, Pa., explains a case where he uses GE's Innova for an arteriogram, embolization and cystography in a single session for a trauma case.

March 22, 2011

Dr. Frederic Deschamps of the Institut Gustavy Roussy, France, explains his use of the Innova TrackVision application to plan and guide needle trajectories during vertebroplasty and oncology procedures.

March 22, 2011

Dr. Thierry DeBaere of the Institut Gustave Roussy in Villejuif, France explains how he uses the GE Heathcare Innova Vision to perform a portal vein embolization on a patient with liver cancer.

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