Bioresorbable stent technology was one of the big interventional technologies discussed at the American College of Cardiology (ACC) 2014 meeting. Doug Drachman, M.D., Mass General Hospital, explains where the technology is today and what we will likely see in the future. Read the article "FDA Approves First Totally Bioresorbable Stent."

A major disappointment earlier this year was the announcement by Medtronic that its renal denervation system failed to meet its primary endpoint for efficacy in the U.S. SYMPLICITY HTN-3 trial. Michael Jaff , D.O., worked as part of the core lab for the trial and explains the trial outcomes and the future of renal denervation technology. He spoke to DAIC Editor Dave Fornell at the 2014 American College of Cardiology (ACC) meeting where the trial results were released.

Related Renal Denervation Content:

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VIDEO: Device Therapies to Treat Hypertension

SPYRAL HTN-OFF MED Study Results Show Efficacy, Safety of Renal Denervation

Medtronic Announces Spyral HTN Global Clinical Trial Program for Renal Denervation

Medtronic Randomizes First Patients in Symplicity HTN-4

Medtronic Says its U.S. Renal Denervation Pivotal Trial Fails to Meet Primary Efficacy Endpoint

The Future of Renal Denervation Following the Failed SYMPLICITY HTN-3 Trial

Scott Lim, M.D., director of the Heart Valve Center at the University of Virginia Medical Center, investigator in the EVEREST and COAPT trials, discusses the MitraClip transcatheter mitral valve repair system at TCT 2013. The device recieved FDA clearance a couple days before TCT.

Read the article "FDA Clears First Transcatheter Mitral Valve Repair Device."
 

This animation, provided by Abbott Vascular, demonstrates how the U.S. Food and Drug Administration (FDA)-cleared MitraClip transcatherer mitral valve repair system is implanted in the heart

The MitraClip was originally designed for high-risk surgical patients, who often will not be operated on by cardiac surgeons because of the mortality risk. These patients might be eligible for this less-invasive treatment option. The MitraClip device used in this transcatheter mitral valve repair (TMVR) procedure only involves a small puncture in the femoral vein, rather than open-heart surgery and the need to stop the heart.

The delivery catheter is pushed up into the heart and a transseptal puncture is made in the atrial wall. The catheter is then advanced from the right into the left atrium. It is bent 90 degrees to access the mitral valve and to attach the clip to the native valve leaflets.

The procedure it performed under transesophageal echocardiography (TEE) in a cath lab. The ultrasound imaging allows real-time assessment of device and valve leaflet positioning and shows when the leaflets are fully engaged by the device for final deployment. In addition, 3-D Doppler ultrasound is used to show blood flow. This is used to identify the location of the regurgitant jet and any residual jet after the device is implanted. To resolve any addition MR seen in the TEE might require the placement of additional clips.

Related Transcatheter Mitral Valve Technology Content:

Treating Mitral Regurgitation in High Risk Patients

VIDEO: Update of Mitral Valve Repair and Replacement Technologies - Interview with Ted Feldman, M.D.

360 View of the TEE Echo Workstation During a MitraClip Procedure

VIDEO: Evolution of Transcatheter Mitral Valve Repair at the University of Colorado — Interview with John Carroll, M.D., and Robert Quaife, M.D.

Read more about the COAPT Trial

VIDEO: MitraClip to Treat Heart Failure - Results of the COAPT Trial — Interview with William Abraham M.D. 

VIDEO: Impact of the COAPT Trial on Heart Failure Patients With Functional Mitral Regurgitation — Interview with Andreas Brieke, M.D.

FDA Approves MitraClip for Use in Heart Failure Patients With Functional Mitral Regurgitation

VIDEO: Echocardiographic Findings in the COAPT Trial — Interview with Federico Asch, M.D.

VIDEO: Transcatheter Mitral Valve Interventions at Henry Ford Hospital — Interview with Marvin Eng, M.D., and William O'Neill, M.D.

VIDEO: Transcatheter Mitral Valve Implantation in Practice and Technologies in Development - Interview with Adam Greenbaum, M.D.

VIDEO: Overview of Transcatheter Mitral Valve Repair Technologies — Interview with Ted Feldman, M.D.

VIDEO: The Cardiac Surgeon Perspective on Transcatheter Mitral Valve Repair — Joe Cleveland, M.D.

Transcatheter Mitral Valve Replacement Devices in Development

VIDEO: Transcatheter Mitral Valve Technology, Anatomical Challenges — Interview with Juan Granada, M.D.

The American College of Cardiology (ACC) 2013 Scientific Session Committee Chairman Miguel Quinones, M.D., explains some of the key highlights from this year's meeting. Highlights included the impact of niacin on lowering cholesterol, new data on transcatheter aortic valve repair, and how mummies show atherosclerosis is not a modern disease.

This short cine loop shows a 3-D/4-D transesophegeal echo (TEE) view of a transcatheter Amplatzer closure device used to seal an atrial septal defect (ASD) and the operation of a surgically implanted St. Jude Medical mechanical mitral valve. This type of complex ASD transcatheter repair is much easier to perform under real-time 3-D TEE guidance. This image was provided by GE Healthcare's Vivid E9 Breakthrough 2012 (BT12), which includes a 4-D transducer for TEE.

One-year results from the ADAPT-DES Trial were presented during TCT 2012. It examined patient hyporesponsiveness to clopidogrel and aspirin in a large-scale, prospective, multicenter study.

Mercy Hospital in Chicago has developed a successful hybrid cath lab program where various specialties work together for the best, minimally invasive patient outcomes. Beyond the coronaries, this cath lab specializes in endovascular aortic stent grafting, peripheral vascular disease, embolization procedures and transcatheter heart valve replacements. Read the related article "Most Innovative Heart Centers: Chicago’s Mercy Hospital."  Watch the related Mercy VIDEO "Mercy Hospital Develops Effective, Collaborative Interventional Program."

The PC Trial data presented at TCT 2012 looked at transcather PFO closure vs. medical therapy in preventing cryptogenic strokes.

Positive results from the RESPECT Trial of transcatheter patent foramen ovale (PFO) closure vs. standard medical therapy were presented by John Carroll, M.D., University of Colorado Hospital, at the Transcatheter Cardiovascular Therapeutics (TCT) 2012 meeting.

Read the article on the trial results — "PFO Closure May Improve Outcomes Over Medical Therapy in Cryptogenic Stroke."

Three big trends were seen in cardiovascular ultrasound during the American Society of Echocardiography (ASE) 2012 meeting. Malissa Wood, M.D., co-director of the Women's Center at Mass General Hospital, Boston, and chair of the ASE Public Relations Committee, explains these trends. The biggest is the expanding use of ultrasound and transesophageal echo (TEE) in the cath lab and hybrid OR for structural heart procedural navigation. Other trends include use of pocket ultrasound and new software advances to simlify and reduce the time it takes to use 3-D echo and make quantifications. For more information: www.dicardiology.com/article/ultrasound-sees-increasing-use-interventional-procedures

One of the most interesting educational exhibits at the recent American College of Cardiology (ACC) 2012 Scientific Session was "The Heart of Innovation" display on the show floor. The ACC in collaboration with marquee sponsor Philips Healthcare and several other industry leaders created this non-accredited, hands-on education experience. The exhibit explored the evolution of the standard-of-care for heart disease and heart failure caused by valvular disease. It looked at these issues through the lenses of personalized medicine, techno-biology, minimally invasive procedures and physician-patient engagement. The exhibit included technology from the past, present and future of healthcare. To incorporate a historical view, the entrance to the display included the ACC's special collection of historic artifacts encompassing medical books, stethoscopes and device technology dating back hundreds of years, including a stethoscope from 1535. This historical perspective was juxtaposed with a modern attendee experience that included the option to explore the entire exhibit with a specially provided iPad tour. The centerpiece was a mockup of a hybrid OR. It included a Corindus CorPath robotic cath lab intervention guidance system. Other partners included Maquet, showing a portable heart-lung machine the size of a small suitcase and the CFI Medical Solutions ZeroGravity radiation protection system. What made the hybrid OR particularly unique was that it was situated across from the Minimally Invasive Gallery, which featured many of the innovations that are driving procedures performed in the hybrid OR. The gallery encompassed solutions from Medtronic and Edwards Lifesciences, including Edward's breakthrough Sapien transcatheter heart valve. The display discussed current treatments and what the future technologies will likely be from the standard-of-care in the future.

The Crux inferior vena cava (IVC) filter was designed for easy deployment and later retrieval. This video clip shows retrieval of the device, which has has radio-opaque markets for easier visualization under angiography. IVC filters are designed for the prevention of pulmonary embolism.

Diagnostic and Interventional Cardiology Editor Dave Fornell discusses trends and shares his choices of the most innovative technologies shown on the floor of the American College of Cardiology (ACC) 2012 Scientific Session, held March 24-27 in Chicago.

A couple of key trends were evident on the show floor included:

   • New technology to support trans-aortic valve replacement (TAVR);

   • Launch of new cardiovascular image and information systems (CVIS) to support healthcare's adoption of proposed Stage 2 meaningful use (MU) requirements;

   • Balloon-inflatable TAVR/EVAR introducer sheath;

   • 3-D intra-cardiac echo;

   • Mobile angiography system for hybrid ORs;

   • Chocolate for heart health.

For more information: www.DIcardiology.com

DAIC editor Dave Fornell explains some of the most innovative cardiovascular imaging technologies showcased by vendors at the Radiological Society of North America (RSNA) meeting in December 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.

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

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.