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, was the principle investigator for a trial that looked at the latest generation of cath lab robotics in a real-world patient population. 

The late-breaking PRECISION GRX Study was presented at the Society of Cardiovascular Angiography and Interventions (SCAI) 2021 meeting. It looked at the use of robotic PCI in real-world patients across a spectrum of lesion complexity. This included use in total chronic occlusions (CTOs), and ostial and bifurcation lesions. 

The robot system allows the operator to sit in a lead-lined booth outside the radiation field to perform the procedures sitting down, and they do not need to wear lead.

Read more on this study — Second Generation Robotic PCI System Performs Well Across Spectrum of Lesion Complexity

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Find more news from the SCAI 2021 virtual meeting

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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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 

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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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

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 Disrupt CAD III study at the 2020 Transcatheter Cardiovascular Therapeutics (TCT) Connect virtual meeting. 

The trial will likely pave the way for U.S. Food and Drug Administration (FDA) clearance for intravascular lithotripsy to be used in the coronary arteries. He offers details on the data and and use of this technology in the cath lab compared to the current techniques of atherectomy, cutting balloons and high pressure balloons that can cause vessel trauma, leading to poorer outcomes. 

The lithotripsy technology breaks up calcium in the vessel walls without trauma, using a compliant balloon and relying on sonic waves to bust the calcium rather than brute force. He said this could be a paradigm shift in how calcified lesions are treated.

Read more on this trial and the technology in the article Shockwave Technology to Sonically Bust Calcified Coronary Lesions Shows Safety and Efficacy in U.S. Pivotal IDE Trial.

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

FDA Clears Coronary Intravascular Lithotripsy to Breakup Calcified Lesions With Sound Waves — Feb. 2021

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

Roxana Mehran, M.D., and Marco Valgimiggle, M.D., present the results of the Xience 90/28 trials that evaluated the use of shortened 3-month and 1-month dual-antiplatelet therapy (DAPT) in high-risk bleeding patients. 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 use of short duration DAPT has been a big topic of discussion at TCT the past few years. The first FDA cleared indication for shortened DAPT was was granted in late September 2020 for the Medtronic Endeavor stent. The data from these two trials will likely lead the Xience to a similar FDA indication expansion. 

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

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

The late-breaking MitraBridge Study was presented at Transcatheter Cardiovascular Therapeutics (TCT) 2020 meeting showed the transcatheter MitraClip mitral leaflet repair system can be used as bridge therapy to heart transplantation. About 25 percent of patients in this study were actually taken off the transplant list because they became asymptomatic.[1] 

This is the press conference for the study presented by Cosmo Godino, M.D., an interventional cardiologist from San Raffaele Hospital, Milan, Italy. It is followed by a discussion by several well-known interventional cardiologists and structural heart experts.

The MitraBridge Study showed the transcatheter MitraClip mitral leaflet repair system can be used as bridge therapy for patients on the heart transplant list. It was used to reduce the amount of mitral regurgitation to help ease symptoms in advanced heart failure who need a need a heart transplant, but may have to wait long periods before a heart becomes available.  

The 119-patient study found it not only helped improve patient symptoms for the majority of patients, but 23.5 percent of patients in this study improved so much they were actually taken off the transplant. 

There is a large and growing imbalance between the demand and supply of donor hearts, Godino explained. With the expansion of waiting lists and prolonged waitings times are generally more than a year and it becomes difficult to manage these patients, resulting in a one-year mortality rate of 15 percent. 

Patients selected for MitraClip had advanced/end stage heart failure and concomitant, severe mitral regurgitation with a median left ventricular ejection fraction of 26%. These patients make up between 1 to 10% of the overall heart failure population, Godino said.

There was an 87.5% procedural success rate and no deaths at 30-day. Two thirds of patients remained free of development of composite adverse events at one-year. Of those that improved, 15.5% become eligible for a heart transplant. nearly a quarter could be removed from the list for HTx due to clinical improvement
 

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

Reference:

1. Cosmo Godino, Andrea Munafò, Andrea Scotti, et al. MitraClip in secondary mitral regurgitation as a bridge to heart transplantation: 1-year outcomes from the International MitraBridge Registry. The Journal of Heart and Lung Transplantation. Published September 16, 2020. DOI: https://doi.org/10.1016/j.healun.2020.09.005.

Ernest Garcia, Ph.D., MASNC, FAHA, endowed professor in cardiac imaging, director of nuclear cardiology R&D laboratory, Emory University, developer of the Emory Cardiac Tool Box used in nuclear imaging and past-president of the American Society of Nuclear Cardiology (ASNC), explains the use of artificial intelligence (AI) in cardiac imaging. He said there is a tsunami of new AI applications that are starting to flood the FDA for market approval, and there are several examples of AI already in use in cardiac imaging. He spoke on this topic in a keynote session at the 2020 ASNC meeting.

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How Artificial Intelligence Will Change Medical Imaging

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VIDEO: ACC Efforts to Advance Evidence-based Implementation of AI in Cardiovascular Care — Interview with John Rumsfeld, M.D.

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For more AI in cardiology content

Matthew Budoff, M.D., director of cardiovascular CT at The Lundquist Institute, and professor of medicine at the David Geffen School of Medicine at UCLA, presented the  EVAPORATE Study final results at the European Society of Cardiology (ESC) 2020 Congress. He explains how cardiac CT was used to monitor patients taking icosapent ethyl (Vascepa) showed it showed a 17 percent reversal of low attenuation plaques in the coronary arteries.

Final results from Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides on Statin Therapy (EVAPORATE) Trial showed a significant reduction in the primary endpoint of icosapent ethyl reducing LAP plaque volume from baseline. Whereas there was a progression of LAP plaque volume in the placebo group. There were significant differences between icosapent ethyl and placebo at study end for secondary endpoints of other types of plaque volume changes, including and sequentially total, total non-calcified, fibrofatty, and fibrous plaque volumes. All regressed in the icosapent ethyl group and progressed in the placebo group, (p<0.01 for all). The only secondary endpoint which did not achieve a significant difference between groups in multivariable modeling was dense calcium (p=0.053).

Read more in the article "Icosapent Ethyl Significantly Reduces Coronary Plaque in EVAPORATE Study."

Find more ESC news

This is a tutorial video on how to perform an artificial intelligence (AI) automated cardiac ejection fraction measurement using the GE Healthcare Vscan Extend point-of-care ultrasound (POCUS) system and the LVivo EF app, developed and licensed by DiA Imaging Analysis. This FDA-cleared app enables an automated edge detection of left ventricular endocardium and calculates end-diastolic, end-systolic volumes and ejection fraction, using apical 4-chamber view.

the LVivo EF app was showcased by GE Healthcare in its virtual booth at the American Society of Echocardiography (ASE) 2020 virtual meeting. POCUS imaging has emerged as a primary imaging modality for bedside assessment of COVID-19 patients in 2020.

Related ASE News and POCUS Content:

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Todd Villines, M.D., FACC, FAHA, MSCCT, explains how artificial intelligence (AI) might be used in the near future to automatically calculate CT calcium scoring and radiomic feature assessments. This was a key take away during the Society of Cardiovascular Computed Tomography (SCCT) 2020 virtual meeting. 

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.

AI is already commercially used to improve CT image reconstruction to increase the diagnostic quality of the images, especially from low-dose scans. AI is now being applied to automate time-consuming tasks in CT image reads, such as manually calculated calcium scores and automated contouring and quantification of anatomy and function of the heart.

Another area that is seeing a lot of research in in radiomics, where AI is being used to sift through thousands of CT scans to look for subtle imaging traits that may indicate the early development or worsening of disease. These subtle changes may not be evident to radiologists reading the scans, but AI software can identify similarities in patients as a trend and alert researchers to look at that specific trait as a potential imaging biomarker.

Other Key Trends and Technology at SCCT:

Top 9 Cardiovascular CT Studies in Past Year 

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

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

VIDEO: Key Cardiac CT Papers Presented at SCCT 2020

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

Impact of Cardiac CT During COVID-19

VIDEO: Artificial Intelligence to Automate CT Calcium Scoring and Radiomics

Todd Villines, M.D., FACC, FAHA, MSCCT, explains some of most influential cardiac CT clinical papers from the past year at the Society of Cardiovascular Computed Tomography (SCCT) 2020 virtual meeting. Among these were the ISCHEMIA Trial, others showing the value of CT is assessing chest pain patients and its ability to act as a gate keeper to the cath lab, and the 2019 European Society of Cardiology (ESC) guidelines that now list cardiac as a preferred imaging modality.

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

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

Todd Villines, M.D., FACC, FAHA, MSCCT, explains some of the discussion on CT used for COVID-19 patients at the Society of Cardiovascular Computed Tomography (SCCT) 2020 virtual meeting in July. He 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. 

Early on in the COVID-19 pandemic in China, CT emerged as a key imaging modality and was found to be able to detect COVID ground glass lesions in the lungs sometimes prior to positive genetic PCR test results. Supporters of CT say the modality offers a way to get detailed anatomical and functional information using a short exam time and limits the exposure of staff to potential or known COVID-19 positive patients.

One area where cardiac CT is seeing a lot of increased his is for the evaluation of thrombus in the left atrial appendage (LAA). This is traditionally done using transesophageal echo (TEE), but it required very close contact with the patient and direct exposure of staff to bodily fluids and potential viral shed from the patient exhaling with each breath.

Related CT During COVID-19 Content:

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Other SCCT Key Trends and New Technology Content:

Top 9 Cardiovascular CT Studies in Past Year 

VIDEO: Coronary Plaque Quantification Will Become Major Risk Assessment

VIDEO: Key Cardiac CT Papers Presented at SCCT 2020

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

VIDEO: Artificial Intelligence to Automate CT Calcium Scoring and Radiomics

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

Interview with Andrew D. Krahn, M.D.,FHRS, head of the division of cardiology at St. Paul’s Hospital, and professor of medicine at the University of British Columbia, and vice president of the Heart Rhythm Society (HRS). He is an expert in long QT syndrome (LQTS) and is involved with the National Long QT Registry. He explains the issues with the drugs being used to treat coronavirus (COVID-19, SARS-CoV-2) patients and why these combined with the cardiac impact of the virus is causing prolonged ECG QT segment prolongation, leading to deadly arrhythmias. COVID-19 can cause myocarditis that causes QT prolongation and the front-line COVID drugs hydroxychloroquine and azithromycin also cause QT prolongation.

The U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication April 23, 2020, reminding doctors there are serious side effects when using hydroxychloroquine and chloroquine in the off-label use to treat COVID-19 patients. This includes potentially life-threatening heart rhythm problems. The FDA said case reports from the FDA Adverse Event Reporting System database, published medical literature and the American Association of Poison Control Centers National Poison Data System are reporting serious heart-related adverse events and patient deaths. Read more about this alert.

The FDA warning confirmed fears from the American Heart Association (AHA), the American College of Cardiology (ACC) and the Heart Rhythm Society (HRS). These societies April 8 jointly published a new guidance, “Considerations for Drug Interactions on QTc in Exploratory COVID-19 (Coronavirus Disease 19) Treatment,” to detail critical cardiovascular considerations in the use of hydroxychloroquine and azithromycin for the treatment of COVID-19. The societies warned that use of  these agents in a large number of patients in combination would results in arrhythmias and deaths. Read more.

However, there are numerous advocates that argue hydroxychloroquine needs to be used in less sick patients who are not already hypoxic to treat COVID, but it is being used primarily in very sick patients where it is not effective. Advocates also argue the drug can be used to help prevent coronavirus, similar to the drug's effect in preventing malaria. In terms of drug safety, advocates argue the drug has been used in millions of patients for more than 50 years without a high risk of arrhythmias. Several trials are now underway in the United States to test its use against COVID-19, but enrollment has been hampered because of the FDA warning. There will likely be more interest in hydroxychloroquine after it was revealed May 18, 2020, that President Trump is taking the drug for prophylaxis against COVID-19.

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