This is an example of the Siemens Corindus CorPath Cath lab robotic system being used for a percutaneous coronary intervention (PCI) stent implant simulation on the expo floor at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) meeting. The system is mounted to the rail of the cath lab patient table and is manually loaded with catheters. The operator sits in a lead-lined booth outside the radiation field of the C-arm and uses joysticks to manipulate the catheters and advance them through vessels. The operators has the same controls for contrast and C-arm movement as they do using the tableside controls.

The main advantages of this systems are very precise catheter movements and removing the operator from the radiation field, so they can perform the procedure sitting down and without the need to wear heavy protective aprons.

The system is being tested to enable remote expert operators at one hospital to use high speed internet connections to perform a robotic PCI at another hospital many miles aways.
Read more 

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First-in-Human Telerobotic Coronary Intervention Procedures Published in EClinicalMedicine

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Robots in the Cath Lab

Oussama Wazni, M.D., section head, electrophysiology, Cleveland Clinic, discusses the results of the recent STOP AF First and Early AF trials. Both showed effectiveness in using early catheter ablation rather than drugs in atrial fibrillation (AF) patients. Both trials used cryo-ballon ablation, but Wazni said it is translatable to use of all cather ablation technologies.

Wazni a principal investigator for the STOP AF First trial and he shares information on the Early AF trial presented as a late-breaking study at the 2020 American Heart Association (AHA).

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VIDEO: Early Ablation Improved Outcomes in Atrial Fibrillation Patients —interview with Oussama Wazni, M.D.

Esophageal Cooling May Help Prevent Injury From Cardiac Ablations

VIDEO: Top New EP Technologies at Heart Rhythm Society 2020 — Interview with Andrew Krahn, M.D.

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New Technologies to Improve Atrial Fibrillation Ablation

VIDEO: Current State of Atrial Fibrillation Ablation Technologies, an interview with Hugh Calkins, M.D., at HRS 2017.

Find more EP technology news and video

Steven Lubitz, M.D., MPH, cardiac electrophysiologist, Massachusetts General Hospital, presented the late-breaking VITAL-AF Trial at the 2020 American Heart Association (AHA) virtual meeting this week. The study looked at screening for atrial fibrillation (AF) in older adults at primary care visits using the AliveCor single-lead electrocardiogram (ECG) device that interfaces with a smartphone or iPad.

The study found screening for AF using a single-lead ECG at primary care visits was not associated with a significant increase in new AF diagnoses among individuals aged 65 years or older compared to usual care. However, screening may be associated with an increased likelihood of diagnosing AF among individuals aged 85 years or older. 

Undiagnosed AFib is associated with increased risk of stroke. There is uncertainty about how best to screen for AF and guidelines differ regarding screening using ECGs. Methods: We conducted a cluster-randomized trial to evaluate whether screening using single-lead ECGs at primary care visits is effective for diagnosing AF. 

Sixteen clinics were randomized 1:1 to an AF screening intervention which offered an AliveCor single-lead ECG to patients aged 65 years or older during routine vital sign assessments, or usual care. AliveCor readings were over-read by cardiologists. Confirmatory diagnostic testing and treatment decisions were made by the primary care provider. 

New AF diagnoses were ascertained based on electronic case identification and manually adjudicated by a clinical endpoint committee. Results: 35,308 patients were included in the trial (n=17,643 intervention [91% screened], n=17,655 control). Patient characteristics were well-balanced between the intervention and control groups, including 12.7% versus 13.2% with prevalent AF, respectively. At one year, 1.52% of individuals in the screening group had new AF diagnosed versus 1.39% in the control group (relative risk [RR] 1.10; 95% confidence interval [CI] 0.92-1.30; P=0.30). New AF diagnoses in the screening and control groups varied by age (0.95% versus 1.00% for age 65-74; P=0.74; 1.84% versus 1.70% for age 75-84; P=0.58; 4.05% versus 2.68% for age 85+; P=0.02) (see figure). New anticoagulation was prescribed in 2.98% versus 2.90% of individuals in the screening and control groups, respectively, overall (RR 1.03; 95%CI 0.91-1.18; P=0.61), and in 72.8% versus 71% with new AF diagnoses (RR 1.02; 95%CI 0.92-1.14; P=0.70).

Find more AHA news, video and late-breakers

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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The Cardiovascular Impact of COVID-19

VIDEO: Multiple Cardiovascular Presentations of COVID-19 in New York — Interview with Justin Fried, M.D., explaining a case that used VV-ECMO abnd VAV-ECMO

VIDEO: Impact of COVID-19 on the Interventional Cardiology Program at Henry Ford Hospital — Interview with William O'Neill, M.D.

Kawasaki-like Inflammatory Disease Affects Children With COVID-19 

VIDEO: Best Practices for Nuclear Cardiology During the COVID-19 Pandemic — Interview with Hicham Skali, M.D.

VIDEO: Cancelling Non-essential Cardiac Procedures During the COVID-19 Outbreak — Interview with Ehtisham Mahmud, M.D. 

VIDEO: 9 Cardiologists Share COVID-19 Takeaways From Across the U.S.  

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Find more cardiology related COVID-19 content

Chuck Simonton, M.D., chief medical officer at Abiomed, discusses some of the new technologies and clinical trials the company is working on and highlighted hemodynamic presentations at the 2020 Transcatheter Cardiovascular Therapeutics (TCT) Connect virtual meeting.

In this interview Simonton discusses:
   • The new Impella 5.5 device
   • The new Impella ECP expandable pump that collapses to a very small diameter to aid vascular access is about to start first-in-human trials.
   • Smart Assist technology that will incorporated artificial intelligence (AI) to better monitor Impella patients.
   • The Door to Unloading (DTU) Trial that is using Impella first in STEMI patients prior to PCI to prevent reperfusion injury
   •The PROTECT III and IV trials. 

Prior Abiomed, Simonton was the CMO at Abbott Vascular, and was a practicing interventional cardiologist for nearly 30 years at Duke University Medical Center and then at the Sanger Clinic. At Sanger he created his own research team to study patient outcomes following the use of new cardiac technologies. He also founded the Carolinas Cardiovascular Research Foundation at the Carolinas Heart Institute, now part of Atrium Health.
 

Find more TCT news, video and the late-breaking studies

Dean Kereiakes, M.D., medical director, The Christ Hospital Heart and Vascular Center, medical director, The Christ Hospital Research Institute, and professor of clinical medicine at The Ohio State University, explains the late-breaking OPTIMIZE Trial at the 2020 Transcatheter Cardiovascular Therapeutics (TCT) Connect virtual meeting. 

OPTIMIZE looked at the safety and efficacy of the novel Svelte drug eluting stent (DES). It is a thin strut cobalt chromium stent that uses a bioresorbable amino acid-based drug carrier to elute sirolimus. It also was designed specifically for transradial access and direct stenting with a very low crossing profile. 

The trial showed the device did not meet non inferiority for existing DES by a small margin, but there were questions raised about the criteria used in the design of the trial being flawed, rather than the device itself. Kereiakes explains these issues in the video. 

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

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

Gregg Stone, M.D., presents the results of a pooled analysis of randomized trials of bivalirudin virus heparin in acute myocardial infarction patients in a press conference at the 2020 Transcatheter Cardiovascular Therapeutics (TCT) Connect virtual meeting.

The study looked at periprocedural anticoagulation during percutaneous corona intervention in AMI patients. There has been conflicting results reported between several trials looking at which drug is best for anticoagulation during cath procedures.

This study pooled data from 8 studies that included more than 27,000 patients. The data included both STEMI and NSTEMI patients.

The pool analysis found STEMI patients, bivalirudin was associated with reductions mortality, serious bleeding and NACE events, despite higher rates of myocardial infarction  (MI) and stent thrombosis compared with heparin. The mortality benefit of bivalirudin was pronounced in patients with a post-PCI bivalirudin infusion to mitigate MI and stent thrombosis risks. 

In NSTEMI patients, bivalirudin was associated with a reduction in 30 day serious bleeding events, but similar rates of mortality, MI and stent thrombosis compared to heparin.

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

This is an example pf the Shockwave Medical Intravascular Lithotripsy (IVL) catheter system designed to break up heavily calcified plaque in coronary and peripheral vessels. The system uses sonic waves that penetrate the vessel wall and crack the calcium without causing vessel trauma, which commonly occurs with atherectomy and high pressure balloon angioplasty.  

This demonstration was on the exhibit floor of the 2019 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting. The material used in the demonstration are gypsum beads.

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Intravascular Lithotripsy: Will This New Investigational Technology Crack Calcium’s Code in the U.S.? — by Dean Kereiakes, M.D.

Intravascular Lithotripsy May Offer Solution for Calcified Coronary Lesions — By Azeem Latib, M.D.

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Ryan Barbaro, M.D., clinical assistant professor, pediatric critical care medicine, University of Michigan, and chair of the Extracorporeal Life Support Organization (ELSO) Registry Committee, explains use of ECMO in COVID-19 patients. 

He was the lead author of recent study using extracorporeal membrane oxygenation (ECMO) to support very ill COVID-19 (SARS-CoV-2) patients. These patients often could not get enough respiratory support from ventilators, or needed circulatory support as well when they went into heart or renal failure.

The study pooled 1,035 severe COVID patients 213 hospitals across 36 countries in the ELSO registry. There is a staggeringly high risk of death rate when ventilators and other care failed to support their lungs. But after they were placed on ECMO, the death rate was less than 40 percent. 

Read more about this study — ECMO Support Found Effective in Sickest of COVID-19 Patients

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VIDEO: Multiple Cardiovascular Presentations of COVID-19 in New York — Interview with Justin Fried, M.D., explaining a case that used VV-ECMO abnd VAV-ECMO

VIDEO: Impact of COVID-19 on the Interventional Cardiology Program at Henry Ford Hospital — Interview with William O'Neill, M.D.

Kawasaki-like Inflammatory Disease Affects Children With COVID-19 

Find more cardiology related COVID-19 content

Peter Weiss M.D., MSc, director of ventricular arrhythmia management and robotics, and assistant clinical professor of medicine at the Heart Institute, Banner University of Arizona Medical Center, Phoenix, takes a video tour of Banner's new robotic electrophysiology (EP) lab. It is the site of the first U.S. install of the Stereotaxis Genesis robotic system. It is a smaller, more refined system from the earlier generation from a decade ago. Weiss performs a guided tour of the lab and its mapping technologies. 

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Stereotaxis and Acutus Medical Announce Strategic Collaboration
 

Find more news on robotic cath lab and EP lab systems

Deepika Thacker, M.D., a pediatric cardiologist with Nemours Children’s Health System, Wilmington, Del., helped discover one of the first cases of multisystem inflammatory syndrome in children (MIS-C) in the United States. She explains how they treated the first and subsequent pediatric patients with the COVID-19 related syndrome. Read more about the first case of MIS-C Nemours treated in the article Case Study Describes One of the First U.S. Cases of MIS-C.

The dangerous Kawasaki Disease-like syndrome occurs in a small number of children exposed to the COVID-19 (SARS-CoV-2) virus. MIS-C is an autoimmune reaction where the COVID appears asymptomatic, but the immune system overeacts to the virus and begins attacking health tissues in the body. It causes severe causes inflammation of the heart, lungs and other vital organs.

CDC Reports 800 U.S. Children Diagnosed With MIC-C

The Centers for Disease Control and Prevention (CDC) reported as of Sept. 10, 2020, there have been 792 confirmed cases in the United States of the rare MIS-C condition in children that is linked to COVID-19.

The agency also reported there have been 16 deaths reported from the MIS-C cases reported in 42 states, New York City and Washington, D.C., as of Sept. 3. Nearly all cases of MIS-C occurred in children who tested positive for the new coronavirus, while the remainder were in children who were around a person with COVID-19.

The CDC report also gave the following statistics:

   • Most cases are in children between the ages of 1 and 14 years, with an average age of 8 years.
   • Cases have occurred in children from <1 year old to 20 years old.
   • More than 70% of reported cases have occurred in children who are Hispanic/Latino (276 cases) or non-Hispanic Black (230 cases).
   • 99% of cases (783) tested positive for SARS CoV-2, the virus that causes COVID-19. The remaining 1% were around someone with COVID-19.
   • Most children developed MIS-C 2-4 weeks after infection with SARS-CoV-2.
   • Slightly more than half (54%) of reported cases were male.
 

Find additional CDC statistics on U.S. MIS-C cases

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Case Study Describes One of the First U.S. Cases of MIS-C

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NIH-funded Project Wants to Identify Children at Risk for MIS-C From COVID-19

Nick West, M.D., chief medical officer for Abbott, explains the details from a survey of 1,400 patients, physicians and healthcare executives in an effort to understand the needs to guide future technology development. Artificial intelligence (AI) is being looked at as a way to better personalize medicine. In the cath lab, AI might be used to help interpret intravascular images as a second set of eyes for the physician. AI also might enable immediate feedback on how to proceed with a case based on current guidelines and clinical evidence.

Read more about the survey in the article "Emerging Technology and Data Key to Closing Treatment Gaps to Improve Cardiovascular Care."

See Part 1 of this video where west describes the key findings of the survey in the VIDEO: Survey Shows Large Disconnect in Medical Technology Across Continuum of Care.

Case is a 6-month-old infant boy admitted to hospital due to respiratory distress then worsened by a pericardial effusion and solitary kidney and renal failure. Diagnosed as multisystem inflammatory syndrome in children (MIS-C) due to COVID-19 exposure. Cardiac ultrasound case submitted to DAIC by Mohamed Shahwan, European Gaza Hospital. 

Related Content on MIS-C:

Kawasaki-like Inflammatory Disease Affects Children With COVID-19

VIDEO: Overview of Multisystem Inflammatory Syndrome in Children (MIS-C) in COVID-19 Exposed Children — Interview with Deepika Thacker, M.D.

Case Study Describes One of the First U.S. Cases of MIS-C

NIH-funded Project Wants to Identify Children at Risk for MIS-C From COVID-19

New Study Looks at Post-COVID-19 Emerging Disease in Children

Cardiac MRI Aids Evaluation of Children With Multisystem Inflammatory Syndrome (MIS-C) Associated With COVID-19

The Cardiovascular Impact of COVID-19

Atlantic Health System’s Morristown Medical Center has opened one of the region’s first radial lounges in its Gagnon Cardiovascular Institute. Radial access lounges are specifically designed to meet the needs of cardiac catheterization patients who have had their procedure performed through a catheter inserted into their radial artery in the wrist, also known as transradial catheterization. This procedure, which has a shorter recovery period and less bleeding risk than traditional cardiac catheterizations done through the femoral (groin) artery, is now an option for many patients who are catheterized in order to conduct a diagnostic angiogram or have an angioplasty or stent procedure. 

Unlike traditional recovery areas for femoral access that require constant compression of the groin for several hours and requires the patient not to move from the bed, radial patients in the lounge sit is recliners and can use the washroom and get coffee and snacks and are able to walk around with just a compression wrist band. lounges like this are being used at several centers for same-day percutaneous coronary intervention (PCI) procedures, eliminating overnight stays and helping to reduce healthcare costs.

Read more about the lounge in the article Atlantic Health Morristown Medical Center Opens Radial Lounge for Post-procedure Recovery.

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VIDEO: Tour of a Radial Access Recovery Lounge That Mimics Cafe Atmosphere — Interview with Jack P. Chen, M.D.

VIDEO: The Benefits of Transradial Access — Interview with Jack P. Chen, M.D.

Radial Access Recovery Lounge Mimics Cafe Atmosphere

VIDEO: History of Radial Artery Access - an interview with Ferdinand Kiemeneij, M.D.

Radial Access Adoption in the United States

VIDEO: New Frontiers in Radial Access — an interview with Mladen I. Vidovich, M.D.

Radial Access, Same-Day Cardiac Procedure Could Save $300 Million Annually

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Transradial Access Celebrates 25 Years

Juan F. Granada, M.D., CEO of the Cardiovascular Research Foundation (CRF) worked on preclinical development work for a couple drug-eluting balloons (DEBs) and offers an overview on the technology. 

Granada also sheds some light on the biggest question regarding drug-coated balloons (DCBs) with the 2019 U.S. Food and Drug Administration warning that the devices might cause higher mortality, based on a December 2018 meta-analysis of trial data that showed an increased mortality signal. This was a big topic of discussion at TCT 2019 and again at SCAI in 2020 and more recent study data has shown there is no safety issue. 

The basic DCB technology is also discussed by Granada, who explains how the excipients used to carry to anti-proliferative drug on the balloon surface and the crystalline structure of the drug are key differentiators. He said these two elements are key in how much drug is delivered and the duration of its elution in the vessel wall.
 

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VIDEO: SCAI Prospective on Key Takeaways at TCT 2019 — Interview with Chandan Devireddy, M.D., including discussion of the LEVANT study results

Enterprise viewers are designed to provide fast and easy access to a patient’s imaging history, and today’s modern healthcare systems require a clinical viewer capable of meeting the diverse needs of a large group of users. GE Healthcare’s Zero Footprint Viewer can quickly and easily display digital images, video clips and cine loops from any department and on many different devices.

It provides access to images and reports from anywhere, whether it’s on the hospital floor, in surgery, in clinic or at home, to allow clinicians to access and develop clinical insights that deliver patient results and drive operational efficiencies.

Learn more at https://www.gehealthcare.com/products/healthcare-it/enterprise-imaging/centricity-universal-viewer-zero-footprint

Advanced visualization company Medis recently purchased Advanced Medical Imaging Development S.r.l. (AMID), which developed software to automatically track and measure strain in echocardiograms. That technology is now being adapted for strain imaging in CT and MRI. Using this imaging data, the software also can noninvasively derive pressure gradient loops and curves, similar to using invasive pulmonary arterial (PA) hemodynamic pressure catheters. This information is useful in monitoring critically ill patients on hemodynamic support and to monitor worsening severity of heart failure. 

The technology was discussed at the 2020 Society of Cardiovascular Computed Tomography (SCCT) virtual meeting. Examples of this technology are presented in this video. 
 

Find more news and video from SCCT 2020

VIDEO: Photon Counting Detectors Will be the Next Major Advance in Computed Tomography
 

Todd Villines, M.D., FACC, FAHA, MSCCT, said photon counting CT detectors were a key new technology discussed at the Society of Cardiovascular Computed Tomography (SCCT) 2020 virtual meeting. He said the technology will likely replace conventional CT detectors in the next decade.

These new detectors also can take a single scan and bin the various energies to reconstruct a range of mono-energtic scan renderings similar to dual-energy CT, but on a wider spectrum of kV levels. This spectral aspect of photon counting also allows material decomposition based on the chemical elements that make up various materials in the scan, including calcium and metals that make up stents, orthopedic implants and replacement heart valves. This enables easier, automated removal of metal blooming artifacts and the ability to clearly image inside calcified arteries.

Villines is the Julian Ruffin Beckwith Professor of Medicine, Division of Cardiovascular Medicine, University of Virginia, editor-in-chief of the Journal of Cardiovascular CT (JCCT),  and SCCT past-president.

Other Key Trends and Technology at SCCT:

Top 9 Cardiovascular CT Studies in Past Year 

VIDEO: Increased Use of Cardiac CT During the COVID-19 Pandemic

VIDEO: Coronary Plaque Quantification Will Become Major Risk Assessment

VIDEO: Key Cardiac CT Papers Presented at SCCT 2020

VIDEO: Artificial Intelligence to Automate CT Calcium Scoring and Radiomics

Low-attenuation Coronary Plaque Burden May Become Next Big Cardiac Risk Assessment

Impact of Cardiac CT During COVID-19