Interview with Campbell Rogers, M.D., chief medical officer of HeartFlow which has developed a CT image-based fractional flow reserve (FFR-CT) algorithm. The technology was recently included as a recommendation for front line chest pain evaluations in the 2021 ACC/AHA chest pain evaluation guidelines.

The new guidelines gave high levels of evidence for the use of computed tomography and FFR-CT cardiac imaging as front line imaging modalities for chest pain evaluation.

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First International Chest Pain Diagnosis Guidelines Released

VIDEO: Why the ASNC Did Not Endorse the 2021 Chest Pain Guidelines — Interview with ASNC President Dennis Calnon, M.D.

American Society of Nuclear Cardiology (ASNC) President Dennis Calnon, M.D., MASNC, FASE, FSCCT, director of cardiac imaging for McConnell Heart Hospital at Riverside Methodist Hospital, and director of nuclear imaging for Ohio Health Heart and Vascular Physicians in Columbus, explains why the society did not endorse the first-ever U.S. or international guideline for the evaluation and diagnosis of patients with acute or stable chest pain.

Nuclear myocardial perfusion imaging (MPI) has been a gold-standard for evaluation of coronary disease in patients for years, and it is included in the new guidelines. However, computed tomography angiography (CTA) has seen immense growth over the past decade and gained a prominent position in the guidelines as a front line imaging modality. This is due to nearly all hospital emergency rooms now having access to CT systems capable of performing immediate cardiac exams. CT has been seen mainly as an anatomical imaging test, but it also can be used for myocardial perfusion imaging using iodine contrast. While CT has had limits with its ability to image through heavily calcified vessels or stents, that is changing with new CT technologies now coming into service.

One new CT technology that is prominently included I the new chest pain guidelines is CT fractional flow reserve (FFR-CT) imaging.  This uses a computational fluid dynamics algorithm to analyze a patient's CTA. It sends back a report and an interactive 3D reconstruction of all the coronary vessels that shows a color coded drop in FFR ratios, which is a measure of blood flow. Past a certain threshold, the reduced flow needs to be treated with revascularization. Lower level blockages can be treated with drug therapies. FFR-CT is widely expected in the coming years to become a gate keeper for invasive diagnostic angiograms. The hope is it will eliminate the need for the majority of cath lab angiogram exams and only send patients to the lab that need a stent or angioplasty. 

However, the ASNC had major issues with FFR-CT being included in the chest pain guidelines. Its board members argued there is need for more evidence and there should have been more information contraindications for its use, which was included on other imaging modalities in the guidelines. They also argued access to the technology has been very limited. Calnon explains more detail in the video on why this was a sticking point and caused the ASNC to not endorse the guidelines.

Read more in the article — First International Chest Pain Diagnosis Guidelines Released

The vendor Radiaction introduced a new type of scatter radiation protection shielding system that mounts to the angiography system in the cath lab. It was shown for the first time at the 2021 Radiological Society of North America (RSNA) annual meeting.

The system uses a motorized series of tungsten-polymer radiation shield plates that extend down from the detector, and up from the X-ray source, to the patient and bottom of the table. This greatly reduces scatter radiation in the lab, by as much as 92% according to the company's research. 

The shields are deployed using a table-side controller. The shield has sensors to stop extending when it comes close to the patient or the table. The shield can be partly pulled back to enable panning the table. The company said the shield can be mounted on existing angiography C-arms.

It has CE mark and is installed clinically in two cath labs in Israel. The company hopes to submit for U.S. FDA review in 2022.

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Srihari Naidu, M.D., FACC, FAHA, FSCAI, is the director of both the cardiac cath labs and Hypertrophic Cardiomyopathy National Center of Excellence at Westchester Medical Center in New York, and chair of Society for Cardiovascular Angiography and Interventions (SCAI) SHOCK committee. He presented a new cardiogenic shock classification system at the 2021 Transcatheter Cardiovascular Therapeutics (TCT) meeting.

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National Cardiogenic Shock Initiative Protocol Shows 71 Percent Survival 

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Find links to all the TCT 2021 late-breakers

Find more TCT news

Tiberio Frisoli, M.D., interventional structural cardiologist, senior staff physician, Henry Ford Hospital, explains how his center performs transcaval transcatheter aortic valve replacement (TAVR) access for patients who have suboptimal abdominal aortic and femoral vascular anatomy. Transcaval access was pioneered at Henry Ford Hospital and involves using femoral vein access and then using a surgical radio frequency cutter to bore a hole from the interior venacava into the aorta to allow the TAVR delivery catheter to path through. 

This procedure was developed to enable more patients to receive TAVR via the preferred femoral access route. Some patients are not candidates for femoral artery access because of calcified lesions and heart atherosclerotic plaque, which narrows the vessel lumen, and makes it difficult to thread catheters through. The transcaval access technique can bypass the restricted arteries or heavy calcified plaques to still enable a minimally invasive procedure without the need for surgery. 

This video was produced in partnership from Henry Ford Hospital.

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Additional articles and videos on Henry Ford Hospital 

Find more structural heart technology content

Dr. Neil Moat, MBBS, chief medical officer of Abbott's structural heart business, explains the latest advances in Abbott's structural heart device program. He discusses data on the MitraClip G4 device, the Global EXPAND registry study looking at its use in a real-world population, and the large amount of interest in treating heart failure patients with this device following the COAPT Trial, which showed dramatically improve outcomes. Moat also discusses advances using the TriClip G4 system, a tricuspid valve version of the MitraClip tailored for this valve position.  

Moat also discusses some of the other new technologies Abbott is developing in the structural heart space. This includes the Tendyne transcatheter mitral valve replacement (TMVR) device, the Portico transcatheter aortic valve replacement (TAVR) device, and the second generation Navitor TAVR valve. He also mentioned Abbott's Amulet transcatheter left atrial appendage (LAA) occlusion device, which gained U.S. FDA clearance this past summer.
 

Hear more about Dr. Moat's views in the VIDEO: Abbott Structural Heart CMO Shares Views on Future of Valve Interventions.

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VIDEO: Comparison Between Watchman vs. Amulet LAA Occluders
 

Doctor Andreas Ruck, interventional cardiologist and head of the mitral/tricuspid program, Karolinska University Hospital, Stockholm, Sweden, explains the latest data on the Boston Scientific Acurate neo2 transcatheter aortic valve replacement (TAVR) system. It demonstrated positive procedural performance, including low rates of paravalvular leak (PVL) and permanent pacemaker implementation, in data presented in late-breaking sessions at the EuroPCR 2021 congress. These areas improved from the trials using the first generation valve. 

The Acurate neo2 valve design enhancements include a 60% larger outer sealing skirt to better conform to challenging anatomies to better minimized PVL.

Boston Scientific said the ACURATE IDE pivotal U.S. trial is currently enrolling patients to evaluate the safety of the ACURATE neo2 Aortic Valve System. In April 2021, the company received FDA approval to modify the trial design to study patients with severe, symptomatic aortic stenosis who are at low risk for open-heart surgery, in addition to those at intermediate, high and extreme risk.

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Boston Scientific to Acquire TAVR Maker Symetis

Ehtisham Mahmud, M.D., division chief of cardiovascular medicine, director of interventional cardiology and the cardiac cath lab at the University of California at San Diego Health, explains how cath lab robotic systems may soon enable interventionalists to perform emergency stroke thrombectomy in patients hundreds of miles away. Corindus/Siemens Healthineers is developing its Corpath GRX robotic system to enable remote telemedicine procedures. Mahmud said this could help significantly improve access to acute stroke care interventions in rural areas. 

Today, the standard of care for stroke is similar to STEMI heart attacks from 40 years ago where tissue plasminogen activator (tPA) is administered in attempts to break up the clot causing ischemic strokes. Outcomes in STEMI greatly improved in the late 1980s and 1990s with the proliferation of angioplasty and percutaneous coronary intervention (PCI) stenting procedures, which became the standard of care in cardiology. Mahmud said acute stroke interventions are following a similar path, but there just are not enough neuro-interventional operators to create large networks for stroke similar to what is now established for STEMI.

He said the Corpath robotic interventions are already conducted remotely from across the room in the cath lab. The idea is that it does not matter if a patient is 10 feet away in the same room or 200 miles away at a smaller hospital to conduct these procedures. This could go a long way to overcoming vast healthcare disparities in smaller, rural hospitals that are far removed from larger centers that are better equipped, and more importantly, have the specialities needed for these procedures.

Once this technology is cleared for use, Mahmud said cardiologists already have the technical skills to perform emergency thrombectomies, but need to learn more about the neuro-vascular bed and how to deal with any adverse events during or after a procedure. He said this lays the ground for creating neuro-cardiology partnerships or care teams to enable this type of care in the near future. 

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Find more news from the SCAI 2021 virtual meeting

Tom Jones, M.D., director, cardiac catheterization laboratories, Seattle Children’s Hospital, and principle investigator of the Medtronic Harmony transcatheter pulmonary valve (TPV) trial 1-year results that were presented as a late breaking trial at  Society of Cardiovascular Angiography and Interventions (SCAI) 2021 Scientific Sessions.

New study results validate the effectiveness of the Harmony TPV system for patients with congenital heart disease (CHD) and severe pulmonary regurgitation (PR). The Harmony TPV is designed to be a less invasive treatment option for patients with a congenital heart defect irregularity in their right ventricular outflow tract (RVOT) that requires a pulmonary valve placement to restore valve function. 

Read more details in th article One-year Results of the Harmony Transcatheter Pulmonary Valve Trial Presented at SCAI 2021. 
 

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Arnold Seto, M.D., MPA, FSCAI, chief of cardiology, Long Beach Veterans Affairs Medical Center and director, interventional cardiology research, UCI Health, and Jordan Safirstein, M.D., FSCAI, director of transradial intervention, Atlantic Health's Morristown Medical Center, were involved in a physician-initiated study to find a new way to cut radial artery access site hemostasis by 50 percent. The late-breaking study presented at SCAI 2021 uses a combination of a StatSeal patch and the TR Band compression bracelet.

Cardiac catherization is increasingly bing performed using transradial approach, now making up 50 percent or more of the access used for U.S. interventional procedures. The Terumo TR Band is used to close the vascular access site. Standard protocols require the band to be left on for at least two hours following the procedure. 

Shorter compression times can help reduce complications with radial artery occlusion, so it is desirable to find ways to shorten compression times, Seto said. He explained clinicians often start to deflate the wrist band balloon after an hour and watch for ooze or blood. If there are signs the wound is not completely sealed, the band is reinflated. Reinflations occurs more that 67 percent of the time, he explained.

"We found with the Statseal, you almost never have to reinflate," Seto said. 

This study shows that time can be reduced in half and with fewer complications by using the additional patch device, which helps sped the clotting process. This can save staff time and possibly leading to faster patient discharge for same-day PCI programs. 

Read more in the article Radial Hemostasis Time Cut by 50 Percent With StatSeal in Combination With TR Band.

SCAI 2021 Late-breaking Clinical Study Results

Find more news from the SCAI 2021 virtual meeting

Ashwin Nathan M.D., a cardiology fellow in the division of Cardiovascular Medicine at the Hospital of the University of Pennsylvania, presented a late-breaking study at the Society of Cardiovascular Angiography and Interventions (SCAI) 2021 meeting that looked at hospital-level percutaneous coronary intervention (PCI) performance data and simulated if what would happen if hospitals removed their highest risk patients. The findings suggest this risk avoidance strategy does not necessarily mean the hospital will get higher performance scores.

Read more in the article Avoiding High-risk Cath Lab Procedures Does Not Necessarily Improve Hospital Scores.

SCAI 2021 Late-breaking Clinical Study Results

Find more news from the SCAI 2021 virtual meeting

William O’Neill, M.D., medical director of the Center for Structural Heart Disease at Henry Ford Hospital, Detroit, explains final data from the National Cardiogenic Shock Initiative Study (NCSI), The study, presented as a late-breaker at the  Society for Cardiovascular Angiography and Interventions (SCAI) 2021 Virtual Scientific Sessions today, showed NCSI protocols increased cardiogenic shock survival from 50% to 72%. This involves using Impella hemodynamic support prior to percutaneous coronary intervention (PCI).

Find more news from the SCAI 2021 virtual meeting

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Behnood Bikdeli M.D., a cardiologist at the Brigham and Women’s Hospital, Harvard Medical School, Boston, offers an overview of numerous trials in progress testing a variety of anticoagulants and antiplatelet agents at different doses for inpatient, outpatient and severely ill ICU, and long-hauler COVID-19 (SARS-CoV-2) patients. Bikdeli is a cardiologist at the Brigham and Women’s Hospital, Harvard Medical School, Boston, and is involved in the Clinical Trials Center, Cardiovascular Research Foundation, New York, and Center for Outcomes Research and Evaluation (CORE), Yale School of Medicine, New Haven, Conn.

He is a the principal investigator for a comprehensive overview of clinical trials looking at anti-thrombotic drug therapies and dosing in coronavirus patients. The article "Recent Randomized Trials of Antithrombotic Therapy for Patients With COVID-19: JACC State-of-the-Art Review" was published online March 16, 2021.

Bikdeli gives an overview of more than 70 studies that are underway or recently completed. He also discussed the need to tailor therapy to specific patients, since there is no "one-size-fits all" approach.

COVID causes thromboembolitic events in patients, including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, heart attacks, and clots that can cause ischemia or infarcts in various organs. While consensus statements on how to treat or protect patients from COVID clotting were published last year, they were based on opinions, not on hard, clinical evidence. The current studies are hoped to offer answers on how to prophylax specific types of COVID patients in the next couple months. 

Bikdeli also served as lead author on the INSPIRATION Randomized Clinical Trial, which was published in March and looked at the effect of intermediate-dose vs. standard-dose prophylactic anticoagulation for COVID patients on extracorporeal membrane oxygenation (ECMO). He discusses the results of this study as well in the video.

Read the article Overview of Randomized Trials of Antithrombotic Therapy for COVID-19 Patients.

Find more COVID cardiology related news and video

COVID-19 Changes Properties Blood Cells
 

Interview with Scott E. Kasner, M.D., who served as the principle investigator for the Gore Cardioform REDUCE trial, and just published an update in March 2021 looking at the five-year outcomes of patent foramen ovale (PFO) closure vs. antiplatelet therapy for cryptogenic stroke.[1]  Kasner is the chief of the Division of Vascular Neurology, vice chair for clinical affairs for the department of neurology, and Ruth M. and Tristram C. Colket, Jr. President's Distinguished Professor of neurology at the University of Pennsylvania Perelman School of Medicine. He also is the director of the Comprehensive Stroke Center at the University of Pennsylvania Health System. 

The findings show continued benefit and safety of PFO closure out to five years. The initial REDUCE trial results were presented as a late-breaking trial in 2017 and showed benefit to PFO closure and led to the U.S. FDA clearance of the Gore Cardioform PFO Occluder devices. It became the second PFO occluder cleared for use in the United States along with the Abbott Amplatzer. 

He said an important part of the a PFO closure program is to have close collaboration between the interventional cardiologists and neurologists for patient selection, therapy and followup. Kasner said like any procedure, it is also important to have enough volume for one or two cardiologists to become proficient at the PFO occluder procedure. 

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VIDEO: PFO Closure Found Beneficial for Cryptogenic Stroke — Presentation of RESPECT Trial results by John Carroll, M.D.

Reference:

1. Five-Year Outcomes of PFO Closure or Antiplatelet Therapy for Cryptogenic Stroke. N Engl J Med/ Published March 11, 2021. 384:970-971. DOI: 10.1056/NEJMc2033779

This is an example of the Medis Medical Imaging Quantitative Flow Ratio (QFR) system that offers a fractional flow reserve (FFR) blood flow measure in coronary vessels based on angiography imaging analysis alone. The FDA-cleared product allows the FFR-angio derived analysis to be performed table side in the cath lab when the patient is on the table for a procedure to determine if a patient requires a stent.

The QRF technology uses two angiography images with contrast, shot from different angles are used to create a 3-D model of the vessel segment and calculate FFR flow past a lesion. The model also can help plan for stenting.

This example was recorded by DAIC Editor Dave Fornell at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) meeting.

Read more about this technology 

Keith Ellis, M.D., is the director of cardiovascular services and the director of the Chest Pain Center at Houston Methodist Sugar Land Hospital, and has been the director of nuclear cardiology for Diagnostic Cardiology of Houston. He explains how his department has implemented protocols and new technology to mitigate COVID-19 contamination risks and to prevent readmissions. New technologies include the use of telemedicine, CT angiography, and a contrast reduction system in the cath lab to prevent kidney injury that would result in a patient readmission. The hospital also is using techniques to help cut procedure times, including use of radial access in the cath lab and abbreviated nuclear scan protocols to shorten exam times.

He said there can be a lot of cardiovascular involvement in severe COVID patients, ranging from development of myocarditis, STEMI with and without clots, arrhythmias, venous thromboembolism (VTE), and the need for hemodynamic support, including ECMO. He said the most surprising management issue with the COVID patients has been the large amount of VTE, often resulting in deep vein thrombosis and pulmonary embolism (PE). Ellis said this often requires interventional strategies, including the use of Ekos ultrasonic catheter based thrombolysis to break up the clots.

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Find more cardiology related COVID-19 content

Chuck Simonton, M.D., chief medical officer at Abiomed, explains when advanced hemodynamic support is required in COVID-19 (SARS-CoV-2) patients. Abiomed received two FDA emergency use authorizations in 2020 to use Impella is certain clinical circumstances, including a provision to use the Impella RP for right heart failure in COVID patients and for the Impella CP to be used in tandem with ECMO to help support critially ill COVID patients.

Find more cardiology related COVID news 

The COMPARE CRUSH Trial looked at the effect of per-hospital crushed prasugrel tablets in patients with STEMI planned for primary percutaneous coronary intervention (PCI).[1] This video is of the press conference presention of this late-breaking study by doctor George Vlachojannis, from UMC Utrecht, at the 2020 Transcatheter Cardiovascular Therapeutics (TCT) Connect virtual meeting. 

The idea was to crush the tablets to enable faster anti-later inhibition, but the findings of this study showed it did not improve TIMI 3 flow on first angiography or ST-segment resolution at 1 hour post PCI.

Find additional TCT 2020 news, video and late-breaking studies

Reference:

1. Vlachojannis GJ, Vogel RF, Wilschut JM, Lemmert ME, Delewi R, Diletti R, van Vliet R, van der Waarden N, Nuis RJ, Paradies V, Alexopoulos D, Zijlstra F, Montalescot G, Angiolillo DJ, Krucoff MW, Van Mieghem NM, Smits PC. COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions: Rationale and design of the COMPARE CRUSH trial. Am Heart J. 2020 Jun;224:10-16. doi: 10.1016/j.ahj.2020.03.005. Epub 2020 Mar 11.

David Cohen, M.D., presents late-breaking data from the STS/ACC Transcatheter Valve Registry (TVT) showing the impact of using cerebral embolic protection devices during transcatheter aortic valve replacement (TAVR). This is the press conference presentation followed by an expert panel discussion at the 2020 Transcatheter Cardiovascular Therapeutics (TCT) Connect virtual meeting.

The stroke rates were initially high in TAVR compared to surgical aortic valve replacement (SAVR), but these rates have decreased in recent years as operators become more proficient during the procedures and the stroke rates are now comparable or lower than SAVR.

Cerebral embolic protection devices were developed to prevent emboli knocked off the aortic walls and from the aortic valve from traveling to the brain. However, this review of embolic protection device performance and use showed 66 percent of the 700 sites in the TVT Registry report not using these devices.

The rate of in-hospital stroke in the embolic protection group of patients was 1.39 percent. The rate of stroke in patients without embolic protection was 1.54 percent. There was no difference inn the rates of death, stroke, major bleeding or device success between these two groups, Cohen said.

The study also included a propensity-weighted analysis where the embolic group has a stroke rate of 1.3 percent and the no protection device group at 1.58 percent. 

Cohen said there was not a significant reduction in in-hospital or 30-day stroke rates. While there its a slight signal toward fewer strokes with embolic protection, he said the findings show clinical equipoise and provide strong rational for ongoing, large-scale randomized, controlled trials to see if embolic protection devices offer meaningful clinical benefit.

Find additional TCT 2020 news, video and late-breaking studies

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Doctor Hans-Josef Feistritzerm, Heart Center of Leipzig, Germany, presents data on the use of general vs. local anesthesia in transcatheter aortic valve implantation (TAVI) from the late-breaking SOLVE-TAVI one-year outcomes trial. This is the press conference at the 2020 Transcatheter Cardiovascular Therapeutics (TCT) Connect virtual meeting. It is followed by an expert panel discussion on the merits and meaning of the results.

The results showed both approaches are safe to use and the outcomes are good.

The trial randomized patients to either self-expandable or balloon-expandable transcatheter aortic valve replacement (TAVR) valves and the procedures used either general or local anesthesia. TAVR centers have been moving toward the procedure becoming a same day surgery to reduce overnight admissions and send them home as an out patient procedure. This can be accomplished using a local anesthesia if transesophageal echo (TEE) is not needed. However, many still use TEE or there are other factors that make this approach more appealing. Local anesthesia generally has a faster recovery time and reduces  potential complications in sicker and older patients.

Find additional TCT 2020 news, video and late-breaking studies

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VIDEO: Tracking Transcatheter Valve Outcomes in the STS-ACC TVT Registry — Interview with John Carroll, M.D.

Key TAVR Takeaways From ACC 2020

U.S. TAVR Outcomes Need Improvement Based on TVT Registry Analysis

FDA Approves TAVR for Low-risk Patients Creates A Paradigm Shift in Cardiology