Highlights

CRT 2019 Day 1 Wrap-Up

CRT 2019 opened Saturday morning with four concurrent sessions, highlighting the multiple tracks that comprise the conference.

CRT Access Closure

One of those was CRT Access Closure. Nelson Bernardo, MD, FSCAI, of MedStar Washington Hospital Center, one of the course directors, welcomed attendees to the Empire Ballroom.

“We’re still in the 8% zone,” Bernardo said in his opening remarks. “That means to say, whatever we do the large-bore access … we still get about 8% vascular complication in large-bore access. … So if we can get down to 1 or 2%, then we’ll do a better job. I’m talking about all complications.”

The first talk after Bernardo was by Poonam Velagapudi, MD, of the University of Nebraska Medical Center. She reported a couple of case examples to describe complications that can happen when using the femoral or radial artery for access, including hematoma, pseudoaneurysm and thrombosis.

CRT Physiology — Live Case

The live case during CRT Physiology on a Saturday was a first, said one of the course directors, Morton J. Kern, MD, MSCAI, of VA Long Beach Health Care System, Long Beach, Calif.

The case was broadcast to the Hampton Ballroom from St. Francis Hospital, Roslyn, N.Y. The operators were Allen Jeremias, MD, FSCAI, and Richard Shlofmitz, MD.

The patient was a 72-year-old male with a history of hypertension, hyperlipidemia and diabetes mellitus. He presented with exertional angina, and a stress test showed anterior lateral wall defect and significant electrocardiogram changes with moderate-intensity exercise, which suggested inducible ischemia. An angiogram revealed a severely diseased circumflex artery, which was treated before the case, and mild to moderate disease of the left anterior descending artery (LAD), which was the focus of the live case, Jeremias said.

The operators performed optical coherence tomography (OCT)-guided percutaneous coronary intervention. Pre-procedure instantaneous wave-free ratio (iFR) demonstrated significant ischemia, despite angiographically mild disease. Orbital atherectomy was used for plaque modification in a severely calcified LAD with abnormal physiology for lesion preparation prior to stent implantation. Post-procedure, OCT confirmed an optimal outcome and demonstrated excellent stent expansion.

CRT Valve Complications

The Blue Room was packed Saturday afternoon for the CRT Valve Complications course.

Pradeep Yadav, MD, of Henry Ford Hospital, Detroit, kicked off the discussion with the case of a 79-year-old woman who presented with dyspnea on exertion for 2 months and was admitted for heart failure for the second time in a three-week period. She was diagnosed with severe symptomatic aortic stenosis and was at intermediate surgical risk. The operators chose to perform a transcatheter aortic valve replacement using an Evolut Pro 29 mm valve (Medtronic) via transfemoral access. When implanting the valve, it landed a bit high and the pigtail moved, so the operators recaptured the valve and adjusted the pigtail. This time, Yadav said, the valve began to open. Pacing was begun at 120 ms “just to avoid that pop-out,” he said. The valve was looking good until it showed shattering on the outer curve.

The operators then took a transthoracic echocardiogram and found that the valve was extending up on the outer curve. A transesophageal echocardiogram showed dissection in the ascending aorta and pericardial effusion starting to develop. So the operators converted her to surgery. When they performed the aortic incision, they saw a 2.5 cm tear just above the sinotubular junction. They folded the valve and placed sutures, closed her chest and discharged her to rehabilitation. Yadav reported that 11 months post-procedure, she “continues to do well.”

Yadav said the complications likely happened at the time of recapture and that the nitinol cage may have moved forward before the nose cone was fully retrieved into the capsule. Partial resheathing is OK, but with a pop-out, the capsule needs to be fully resheathed to avoid a dissection, he said.

Looking ahead

On Day 2, CRT will kick into full gear, with the first late-breaking trial results, keynote speeches by Jean Chatzky and Soledad O’Brien, and CRT’s second straight year of presenting an all-women live case.

CRT 2019 Day 2 Wrap-Up

CRT 2019 kicked into high gear on the second day. Women in Interventional Cardiology took center stage, we had our first two keynote speakers, and the first set of late-breaking trial results were presented.

Late-Breaking Trial Results

Four late-breaking trial results were presented Sunday afternoon:

  • A post-hoc analysis of studies of post-acute coronary syndrome or post-chronic heart failure patients on dual antiplatelet therapy found that the addition of 2.5 mg of rivaroxaban twice daily led to a reduction in adverse events and all-cause mortality, according to results presented by C. Michael Gibson, MD, of MS, MD, of Beth Israel Deaconess Medical Center, Boston. (Read more here.)
  • A sub-analysis of the Lipid-Rich Plaque trial supported the ability of near-infrared spectroscopy to identify vulnerable plaques even after the adjustment for intravascular ultrasound parameters, according to results presented by Ron Waksman, MD, FSCAI, of MedStar Washington Hospital Center and CRT Course Chairman. (Read more here.)
  • The AngelMed Guardian implantable cardiac monitor (Angel Medical Corp., Eatontown, N.J.) was found to be safe in acute coronary syndrome patients, though it failed to meet its primary endpoint in the ALERTS trial to identify future myocardial infarctions, according to results presented by Gibson. (Read more here.)
  • The BIO-RESORT trial demonstrated the safety and efficacy of three contemporary drug-eluting stents — the biodegradable-polymer-coated Orsiro sirolimus-eluting stent (Biotronik), biodegradable-polymer-coated Synergy everolimus-eluting stent (Boston Scientific) and durable-polymer-coated Resolute Integrity zotarolimus-eluting stent (Medtronic) — at 3 years post-implantation, according to results presented by Clemens von Birgelen, MD, PhD, of Thoraxcentrum Twente, Enschede, Netherlands. (Read more here.)

Women & Heart Symposium

Alexandra J. Lansky, MD, FSCAI, of Yale University School of Medicine, moderated the “Women in Heart Symposium — Interventional Cardiology: Prevention, Detection and Treatment” in a packed Regency Ballroom. The first panel discussion focused on the challenges and opportunities that Women in Interventional Cardiology face.

American financial journalist Jean Chatzky talked about finances and health, two subjects she said must be considered together as people get older.

Chatzky said that while financial and health wellness are important for everyone, they are especially so for women. Even though awareness that heart disease is a leading killer of women has increased, they are still less likely to be medicated for their cardiac needs, to be offered cardiac rehabilitation and to be prescribed lifestyle changes.

CRT Coronary Imaging

During the CRT Coronary Imaging session Richard Shlofmitz, MD, and Allen Jeremias, MD, FSCAI, performed a live case from St. Francis Hospital in Roslyn, N.Y.  The live case featured physiologic assessment with a new non-hyperemic resting index, called resting full-cycle ratio (RFR), which was used to assess a lesion in the left anterior descending artery to confirm ischemia. Following predilatation, optical coherence tomography (OCT) was used to select an appropriately-sized stent and optimal landing zone. After stent implantation, OCT imaging and physiologic assessment confirmed successful percutaneous coronary imaging (PCI).

All-Women Live Case

CRT became the first major interventional cardiology conference to feature an all-women live case last year. The popular live case returned this year, this time from Yale New Haven Hospital, New Haven, Conn. Sasanka Jayasuriya, FACC, FSCAI, and colleagues performed PCI on an 80-year-old man with progressive shortness of breath (New York Heart Association class III heart failure) for the previous 4 months. He had a history that included aortic stenosis, non-insulin-dependent diabetes mellitus, moderate mitral regurgitation and post-operative stroke with no residual deficit. Lansky moderated the panel in the Regency Ballroom.

Disparities: Inequalities in Interventional Cardiology

Another favorite feature of CRT is the Disparities symposium, with Wayne Batchelor, MD, MHS, of Southern Medical Group, Tallahassee, Fla., and Kim Allan Williams Sr., MD, MACC, of Rush University Medical Center, Chicago, serving as co-course directors.

American journalist Soledad O’Brien was the keynote speaker. She challenged journalists to tell stories about all people, including racial minorities and those living in poverty, with nuance and depth instead of the “obvious” and shallow stories focusing on crime in low-income and minority neighborhoods. She also challenged cardiologists to not just speak to each other about racial disparities, but to speak to the world.

She pointed out that people claiming to represent the medical community who are not really medical professionals speak for real practicing clinicians on TV news programs.

“You should be mad!” O’Brien said, encouraging those attending to let their voices be heard.

Looking ahead

Day 3 will be the busiest yet of CRT 2019, with more late-breaking trial presentations, the Women in Interventional Cardiology roundtable discussion and CRT keynote speaker Tony Blair, Prime Minister of the United Kingdom from 1997-2007.

CRT 2019 Day 3 Wrap-Up

The third day of CRT 2019 was action-packed, featuring eight late-breaking trial presentations, nine live cases, and the return of the Women in Interventional Cardiology roundtable. And, of course, Tony Blair, the Prime Minister of the United Kingdom from 1997-2007, capped the day with the conference keynote speech.

Late-Breaking Trial Results

Eight late-breaking trial results were presented Monday:

  • Splitting the anterior mitral valve leaflet before percutaneous mitral valve replacement, a technique called LAMPOON, prevents left ventricular outflow tract (LVOT) obstruction in patients at high risk for surgical mitral valve replacement or repair, according to a trial presented by Jaffar M. Khan, BM BCh, of the National Institutes of Health’s National Heart, Lung and Blood Institute (NHLBI) and MedStar Washington Hospital Center (MWHC).
  • Transcatheter aortic valve replacement (TAVR) continued to be safe in patients at low risk of surgical mortality with symptomatic severe aortic stenosis (AS) 1 year post-procedure, according to results presented by Ron Waksman, MD, FSCAI, of MWHC and CRT Course Chairman.
  • Splitting the target aortic valve leaflet immediately before TAVR, a technique called BASILICA, can prevent coronary obstruction, according to another trial presented by Khan.
  • Newer technology appears to be making TAVR safer in patients with severe symptomatic aortic stenosis who are at intermediate surgical risk, according to a propensity-matched sub-analysis of the SURTAVI continued access study (CAS) presented by Steven J. Yakubov, MD, of OhioHealth/Riverside Methodist Hospital, Columbus, Ohio.
  • A physiology substudy of the ABSORB II trial showed evidence supporting a long-term benefit of bioresorbable vascular scaffolds (BVS) on coronary function, in comparison with metallic stents, according to trial results presented by Javier Escaned, MD PhD, of Hospital Clinico San Carlos, Madrid, Spain.
  • Another non-hyperemic pressure ratio measure, called resting full-cycle ratio (RFR), achieved statistical equivalency to instantaneous wave-free ratio (iFR), Gautam Kumar, MD, FSCAI, of Emory University/Atlanta VA Medical Center, said in his trial presentation.
  • An analysis of the first 600 patients in the BIOSOLVE-IV registry presented by Stefano Galli, MD, of Centro Cardiologico Monzino, Milan, Italy, confirms low target lesion failure rates of the Magmaris stent shown in previous trials.
  • Alcohol-mediated renal denervation using the Peregrine System Infusion Catheter (Kalamazoo, Mich.) safely and efficiently lowers blood pressure, Horst Sievert, MD, FSCAI, FACC, of CardioVascular Center Frankfurt, Germany, said in his late-breaking trial presentation.

 

Live Cases

  • Nelson L. Bernardo, MD, FSCAI, of MedStar Washington Hospital Center (MWHC), performed peripheral endovascular intervention on an isolated chronic infrarenal abdominal aortic dissection in a patient presenting with life-limiting claudication. Bilateral femoral arterial access was obtained and intravascular ultrasound was utilized to facilitate access to the true lumen. Endovascular aortic repair was performed with the Ovation abdominal stent graft system (TriVascular, Inc., Santa Rosa, Calif.) with excellent final results.
  • A chronic total occlusion was planned for another live case at MWHC; however, a patient came in with an acute ST-elevation myocardial infarction (STEMI). Robert Gallino, MD, and Hayder Hashim, MD, both of MWHC, treated an acute 100% proximal left anterior descending artery (LAD) occlusion with an Orsiro drug-eluting stent (Biotronik AG, Bülach, Switzerland). This with one of the first implants in the U.S. of this new stent, which was just approved this week. The patient was treated with intravenous cangrelor (Chiesi). Procedural optimization was guided by optical coherence tomography imaging and demonstrated resolution of thrombus.
  • And in still another live case at MWHC, Toby Rogers, MD, PhD, and Jaffar M. Khan, BM BCh, both of the National Institutes of Health’s National Heart, Lung and Blood Institute and MWHC, demonstrated the BASILICA technique to prevent coronary obstruction and enable valve-in-valve TAVR.

Women in Interventional Cardiology
CRT’s Women in Interventional Cardiology roundtable was Monday afternoon. Its popularity last year resulted in it being held in larger room this year. Micaela Iantorno, MD, MHS, an interventional cardiology fellow at MWHC, takes it from here:

“The roundtable focused time on effective communication to become a leader in the field. As women in interventional cardiology, we face challenges, and it is a reality that we sometime feel intimated by our male counterparts. This was a new initiative, but probably both women and men would benefit from it. Maybe in future roundtables, there can be some tips and guidance on career planning and job searches.”

Keynote Speech: Tony Blair

Former UK Prime Minister Tony Blair was a big hit with the CRT audience in the Regency Ballroom on Monday night. He regaled CRT Course Chairman Ron Waksman, MD, with a series of zinger quotes in response to questions about his time as Prime Minister, his view of Brexit and his thoughts on the state of the world today.

But perhaps it was Mr. Blair’s closing that drew the warmest response, when Dr. Waksman asked what advice Mr. Blair would have for the young interventional cardiologists at CRT.

“Go out and learn about the world. Don’t just learn about your profession,” Mr. Blair said. “Learn about the world. Learn about other cultures. Learn about other countries. Learn about how people in other parts of the world deal with these problems. It’s an exciting world.

“And I say for all the challenges, we’re marking progress. When you look at the broad sweep of history, humanity is making progress. And it’s making progress because there are people prepared to go out and make a difference and change the world.

“The other thing I would say to you is, however successful you are … you will always find the single most satisfying thing is to serve other people. All the rest is fantastic, but in the end, the thing that really makes you feel fulfilled is when you make a difference not just in your own life but in the lives of others.”

Looking ahead

The fourth and final day of CRT 2019 is Tuesday, featuring the Drug-Coated Balloon Safety Town Hall, the popular HHS/FDA Town Hall, and the announcement of the Best Innovation at CRT.

CRT 2019 Day 4 Wrap-Up

CRT 2019 finished strong with the final set of late-breaking trial results, the announcement of the Best Innovation for CRT 2019, more live cases and the Drug-Coated Balloon Safety Town Hall.

Late-Breaking Trials

  • The Lutonix paclitaxel-coated balloon demonstrated excellent safety and freedom from revascularization at 1 year, according to SAFE-DCB registry results presented by Nicolas W. Shammas, MD, MS, FACC, FSCAI, president and research director of the Midwest Cardiovascular Research Foundation.
  • A novel device successfully closed transcaval access in the setting of transcatheter aortic valve replacement in all study patients, according to trial results presented by Toby Rogers, MD, PhD, of the National Institutes of Health’s National Heart, Lung and Blood Institute and MedStar Washington Hospital Center (MWHC).
  • The Eximo Medical B-Laser is safe and effective at reducing residual diameter stenosis in all infrainguinal lesion subtypes, according to another trial presented by Shammas.

Best Innovation

Toby Rogers, MD, PhD, capped off his conference by winning the Best Innovation for CRT 2019 with Transcatheter Mitral Cerclage Annuloplasty. Rogers offered the following explanation:

Mitral cerclage is intended to treat patients with symptomatic severe functional mitral valve regurgitation. Functional mitral valve regurgitation is caused by left ventricle dilation, which results in mitral valve annular dilation and map-coaptation of the otherwise normal mitral valve leaflets. The resulting mitral regurgitation leads to heart failure symptoms.

Mitral cerclage annuloplasty is a catheter procedure performed under X-ray and ultrasound guidance without surgery. The cerclage device compresses the mitral valve like a purse-string to affect circumferential annuloplasty and reduce the septal-lateral dimension of the mitral annulus. The cerclage device partially lies within the coronary sinus and incorporates a rigid bridge-shaped element that prevents coronary artery compression as the device is tightened to treat mitral regurgitation.

Importantly, cerclage does not preclude other transcatheter mitral valve therapies in the future, including edge-to-edge mitral valve repair (e.g., MitraClip), transcatheter mitral valve replacement, or surgery. This stands in stark contrast with edge-to-edge repair, which is commonly performed outside the U.S. for functional mitral regurgitation. 

Clinical testing outside the U.S. has shown early promise: Cerclage is a simple right-sided technique performed under mostly fluoroscopic guidance. In a first-in-human study in South Korea, dramatic cardiac chamber reverse remodeling and electrical remodeling was observed. 

The latest-generation Transmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA) device, developed in collaboration with physicians from the National Heart Lung and Blood Institute, is a fully percutaneous, reversible (even after tensioning and release), right-sided, fully circumferential mitral annuloplasty system that is implanted via the right jugular vein. The U.S. Food and Drug Administration granted an investigational device exemption for the Transmural Systems TMCA device in February 2019. Rogers led the pre-clinical development of the TMCA device

"We are excited to announce that we will be enrolling into an Early Feasibility Study (EFS) for Mitral Cerclage Annuloplasty here in the United States in April 2019,” he said after winning the CRT Best Innovation Award.

The runner-up was Azeem Latib, MD, of San Raffaele Scientific Institute, Milan, Italy, for his innovation, “Reproducible and Controlled Transseptal Puncture System.”

The Best Innovation competition had a new two-day format this year. The initial entries were presented Monday, and the top five advanced to Tuesday.

Latib had a second entry in the top five, “Controlled Flow Infusion: A New Approach to Measure dynamic Microvascular Resistance (dMVR) and to Treat Microvascular Obstruction (MVO) in Acute Heart Attack Patients in the Cath Lab.” The rest of the top entries were “Heartflow Planner: Pre-procedural Planning to Optimize Treatment,” by Charles Taylor, PhD, founder and chief technology officer of HeartFlow, Redwood City, Calif.; and “Second Heart: A Minimally Invasive Cardiac Assist Device,” by Leslie Miller, MD, of chief medical officer of Second Heart Assist Inc., of Salt Lake City, Utah.

DCB Safety Town Hall

A new feature at CRT this year, the Drug-Coated Balloon (DCB) Safety Town Hall packed the Empire Ballroom. The focus was on the scrutiny that paclitaxel-coated devices have received since a meta-analysis by Konstantinos Katsanos, MD, PhD, MSc, EBIR, of Patras University Hospital, Greece, and colleagues, published Dec. 6, 2018, in the Journal of the American Heart Association. Katsanos and colleagues’ manuscript reported higher all-cause mortality in patients undergoing treatment of femoropopliteal disease with paclitaxel-coated devices compared to control groups in 28 randomized controlled trials.

Katsanos himself was at the town hall Tuesday. He explained and defended the paper under some intense questioning about statistical methods used in reporting the meta-analysis.

The panel and presenters represented interventional cardiologists, researchers, biostatisticians and industry. At the end, panelists voted on four questions and discussed them.

The first was, “Given the data from the meta-analysis and other data that was presented today, is there a safety signal for paclitaxel DCB in the SFA (superficial femoral artery)?” The tally of votes, taken anonymously, was 10 yes, zero no and four “I don’t know.”

The second was, “Should the current labeling for DCB and DES (drug-eluting stent) with paclitaxel be restricted, changed or unchanged?” The tally was three votes for restricted, three for changed and eight for unchanged.

“Changed” was indefinite, CRT Course Chairman Ron Waksman, MD, FSCAI, of MWHC, pointed out, as it could include expanding or restricting the use.

The third question was, “Should patients be informed about the paclitaxel controversy prior to intervention with a paclitaxel device?” Jeffrey J. Popma, MD, FSCAI, of Beth Israel Deaconess Medical Center, Boston, who was a co-moderator of the town hall, polled the audience. Nearly all audience members raised their hands to indicate that patients should be informed. Popma said the vote was similar with the panel: 10 voted yes, patients should be informed, and one voted “I don’t know.”

The fourth and final question was, “Is the patient-level data of all paclitaxel systems poolable for definitive analysis?” The tally was nine yes, one no and four “I don’t know.”

After the daylong town hall, Popma summed up the current state of the paclitaxel device debate: “I came in with uncertainty, and now I’m going away with uncertainty, but we made tremendous progress.”

Town hall co-moderator David E. Kandzari, MD, FSCAI, of Piedmont Heart Institute, Atlanta, added: “I know I don’t know, and I want to thank everybody, our audience, for attending and staying with us for a full day of terrific presentations.”

Live Cases

The live cases continued through CRT’s last day.

In one case from MWHC, a peripheral vascular intervention was performed on a patient who presented with numbness of the right arm, forearm and fingers. On diagnostic angiography, he was noted to have severely calcified lesion at the ostium of the brachiocephalic trunk with significant gradient requiring endovascular intervention. Nelson L. Bernardo, MD, FSCAI, utilized the Shockwave IVL (Shockwave Medical Inc., Fremont, Calif.) device to disrupt the calcium to facilitate stent delivery with excellent final angiographic results.

In another case, from MWHC, during the Complex Coronary session, a 65-year-old male who came in for treatment of in-stent restenosis of a proximal right coronary artery (RCA) lesion. Invasive physiologic lesion assessment confirmed ischemia, with an abnormal Pd/Pa and fractional flow reserve. The RCA stent extended beyond the ostium, protruding into the aorta. Itsik Ben-Dor, MD, used The FLASH™ Ostial System Dual-Balloon Angioplasty Catheter system (Ostial Corporation). Post-percutaneous coronary intervention intravascular ultrasound confirmed an optimal result.

Looking ahead

That’s it for CRT 2019. We wish you safe travels home, and we will see you next year at a new venue, the Gaylord National Resort & Convention Center in National Harbor, Md., for CRT 2020!