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

Here are two examples of artificial intelligence (AI) driven pulmonary embolism (PE) response team apps featured by vendors Aidoc and Viz.AI at the 2021 Radiological Society of North America (RSNA) 2021 meeting.

The AI scans computed tomography (CT) image datasets as they came off the imaging system and looked for evidence of PE. If detected by the algorithm, it immediately sends an alert to the stroke care team members via smartphone messaging. This is done before the images are even loaded into the PACS. The radiologist on the team can use a link on the app to open the CT dataset and has basic tools for scrolling, windowing and leveling to determine if there is a PE and the severity. The team can then use the app to send messages, access patient information, imaging and reports. This enabled them all to be on the same page and can communicate quickly via mobile devices, rather than being required to use dedicated workstations in the hospital. 

Both vendors showed similar apps for stroke at RSNA 2019. That idea for rapid alerts, diagnosis and communications for acute care teams has now expanded to PE and also for aortic dissection and abdominal aortic aneurysms (AAA). AI.Viz and Aidoc are looking at expanding this type of technology for other acute care team rolls, including heart failure response. 

Read more about this technology in the article AI Can Facilitate Automated Activation of Pulmonary Embolism Response Teams.

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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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Examples of TrueView and GlassView 3D cardiac ultrasound visualization and artificial intelligence (AI) assisted automated measurements on the Philips Healthcare Epiq CV version 9.0 echo system. The latest version of the system was FDA cleared in October 2021 and shown at the 2021 Radiological Society of North America (RSNA) meeting for the first time. The Epiq is an AI-based platform, starting with anatomical intelligence to identify the anatomy being images automatically. The latest version of the system adds additional AI auto measurements and quantification to save time, speed workflow and reduce intra-operator variability. 

The short video shows photo-realistic rendering of the mitral valve and a new feature where the opacity of the tissue can be dialed in our out to show glass-like ghost view of the tissue. This can make it easier to navigate or see anatomical landmarks without rotating or slicing through the image planes in the 3D rendering.

Find more RSNA news and video

Find more cardiac echo technology news
 

Susan Cheng, M.D., MPH, director of the Institute for Research on Healthy Aging in the Department of Cardiology at Cedars-Sinai, moderated the Best Science in Cardiovascular Genetics and Genomics: Building Blocks to Better Outcomes, at the American Heart Association (AHA) 2021 meeting. She is an expert in cardiac genetic testing and said tailoring LDL-lowering drug therapy based on routine genetic tests is coming, but is still a few years off.

Find more AHA 2021 late-breaking studies and video

Dr. Simon Dixon, MBChB, chair of the Department of Cardiovascular Medicine at Beaumont Hospital Royal Oak, the Dorothy Susan Timmis Endowed Chair of Cardiology, and a professor of medicine at Oakland University William Beaumont School of Medicine, spoke at the 2021 Transcatheter Cardiovascular Therapeutics (TCT) meeting about a study Beaumont performed to lower radiation dose in the cath lab by more than 50%.

Using a new angiographic collimation technology from ControlRad, it helped cut radiation dose to interventional cardiologists by 57%. The device collimates the area of interest where the physicians are working, and reduces the dose significantly to peripheral areas in the image. This reduces exposure to ionizing X-ray radiation scatter from the imaging system. It is one of two new radiation protection systems used at Beaumont.

The ControlRad device, approved for commercial cath lab use by the FDA in December 2020, is retrofitted to X-ray equipment in the catheterization lab. It creates a type of aperture that collimates the image area being viewed. By using a touch pad attached to the table side rail, the cardiologist controls the aperture to narrow or widen the field of view on the X-ray, which in turn reduces the amount of radiation used to produce the images. It works with gloves on.

For the study, cath lab workers wore radiation-detecting badges near their thyroid and inside their lead apron during procedures. Another badge was placed on a wall inside the lab. The study detected a 55% to 57% decrease in radiation exposure at the thyroid position of the main cardiologist, or lead operator, and a 49% decrease in radiation exposure to the cardiologist assisting, or operator 2. The badge on the wall detected a 38% decrease in radiation exposure, reflecting the dose savings to other cath lab staff further away from the imaging system.

Beaumont is also using the the Protego system, which places a barrier wall between the imaging equipment and the operator and staff in the cath lab. While it does not protect the patient from radiation during their procedure, it is designed to allow staff to work in the cath lab without wearing a heavy lead apron.

Find links to all the TCT 2021 late-breakers

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Khaldoun Tarakji, M.D., MPH, associate section head, cardiac electrophysiology, Heart and Vascular Institute at Cleveland Clinic, was the lead author on a followup study to the landmark WRAP-IT trial that showed the Tyrx bioresorbable antibacterial envelope was shown it significantly lower infection risk for patients who receive cardiac implantable electronic devices (CIED) and develop hematomas.[1] 

The study results showed an 82% reduction in major infection among patients with hematoma in patients who had received the Tyrx. It is a antimicrobial envelope that is used to place implantable electrophysiology (EP) devices inside prior to closing the device pocket. While the envelope itself did not prevent hemotomas, as the rate was the same in the control group with out it, the Tyrx did lower infection rates in patients with hemotomas.

Read more in the article Tyrx Absorbable Antibacterial Envelope Effectively Reduces Infections in Cardiac Device Patients with Hematomas.

Reference:

1. Khaldoun G. Tarakji, Panagiotis Korantzopoulos, Francois Philippon, Jeff D. Lande, Swathi Seshadri, Bruce L. Wilkoff, et al. Infectious consequences of hematoma from cardiac implantable electronic device procedures and the role of the antibiotic envelope: A WRAP-IT Trial Analysis. Heart Rhythm. Punlished online July 16, 2021. DOI:https://doi.org/10.1016/j.hrthm.2021.07.011.

The vendor MediCardia demonstrated smart software to aggregate cardiology patient data from numerous locations into one place at the 2021 Healthcare Information Management Systems Society (HIMSS) conference. This enables one dashboard view of the patient's relevant cardiac history, prior exams, imaging, ECGs, labs and procedures. It also uses artificial intelligence (AI) to pull key data elements about the patient to automatically create risk assessments based on current guidelines in a graphical format.

The interactive system also allows the cardiologist to adjust parameters in the patient risk score to immediately show the patient any impact on their score. This includes if they stopped smoking, began taking statins, etc. The dynamic graphics of the system are also designed to be more engaging with a patient during consultations, rather than plain white pages of reports.

MediCardia HeartChart is a cardiology-focused virtual care platform that serves as a unified and common interface for EHRs and remote technologies including wearables, consumer home medical devices, and implanted cardiac rhythm devices. 

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Jass Brooks, vice president of global strategic marketing, Biosense Webster, explains four over-arching electrophysiology (EP) trends at the 2021 Heart Rhythm Society (HRS) meeting. The vendor is working on developing, or has introduced, new technologies in each of these four areas.  She said the key technology trends include:

   • Pulsed field ablation (also called electroporation) as a new way to ablate cardiac tissue without damaging underlying structures like the esophagus. 

   • The introduction of 3D/4D intra-cardiac echo (ICE) imaging to better guide procedures.

   • High-density electromapping systems that create more accurate maps of the electrical activity in the heart and can do so faster than previous generation mapping systems.

   • The introduction of artificial intelligence (AI) into EP systems to speed workflow.

Key among this company's new product introductions at HRS 2021 was the Octaray high-density electro-mapping catheter, which enables faster mapping with a larger number of points. This enables more detailed maps of the heart's electrical activity and may imporve ablation procedure guidance and outcomes. Recent changes to the Carto electro-mapping system now enables integration of this new technology.

Biosense Webster also introduced the Nuvision 4-D intra-cardiac echo (ICE) ultrasound catheter with imaging support from GE Healthcare Vivid Ultra Edition ultrasound systems. This moved ICE beyond 2-D imaging to real-time 3-D and 4-D imaging inside the heart to enable better procedural navigation and visualization of the catheters within in the heart.

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Federico Asch, M.D., FASE, director of cardiovascular core labs, cardiovascular imaging, MedStar Health Research Institute, Washington, D.C., was involved in a study that used artificial intelligence (AI) to evaluate echocardiograms to identify COVID-19 patients who were at high risk for complications and mortality. The study also compared human vs. AI variability in reading the stories and found much less variability with the machine reviews. He presented the results from the WASE-COVID Study at the American College of Cardiology (ACC) and American Society of Echocardiography (ASE) 2021 meetings. 

Asch also offers insights about AI applications in echocardiography and how the technology will help improve imaging and reduce the variability in how measurements are made, which will decrease the current level of variability in how exams are performed by human operators. He also explains AI is now available to help guide novice ultrasound users to get optimal cardiac ultrasound images.

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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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Payam Dehghani, M.D.,  FRCPC, FACC, FSCAI, co-director of Prairie Vascular Research and associate professor at the University of Saskatchewan, explains the findings of the North American COVID-19 Myocardial Infarction (NACMI) Registry. He presented this late-breaking study data at the at the Society of Cardiovascular Angiography and Interventions (SCAI) 2021 meeting.

The study found one third of patients will die who have COVID-19 (SARS-CoV-2) and suffer a ST-elevated myocardial infarction (STEMI), which is alarming high as compared to four-in-100 patients using a pre-pandemic control group.

 The prospective, ongoing observational registry was created under the guidance of the SCAI, Canadian Association of Interventional Cardiology (CAIC) and American College of Cardiology (ACC). The initial results of the registry were published in the Journal for American College of Cardiology (JACC) on April 27, 2021.

Important key findings from the registry data include:
   • Minorities were disproportionally affected: 55 percent of the STEMI patients had minority ethnicity, which was about evenly divided between Hispanics and blacks.
   • In-hospital mortality was high: 33 percent (4 percent for controls without COVID).
   • Symptoms were unique: majority (54 percent) presented with respiratory symptoms (shortness of breath) rather than chest pain.
   • Significant proportion of COVID-positive patients presented with high-risk STEMI: cardiogenic shock (18 percent) and cardiac arrest (11 percent), which may explain the high fatality rate.
   • Primary angioplasty remained the dominant revascularization modality during the pandemic with small treatment delays (at about 15 minutes). 
   • Diabetics are known to have some of the worst outcomes if they contract COVID, and this was reflected in the study, with 45 percent of patients having diabetes. 

Read more in the artice Third of COVID Patients With STEMI Heart Attacks Die.

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SCAI 2021 Late-breaking Clinical Study Results

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Ashwin Nathan M.D., a cardiology fellow at the Hospital of the University of Pennsylvania, presented a late-breaking study on the socioeconomic and geographic access to transcatheter aortic valve replacement (TAVR) programs at the Society of Cardiovascular Angiography and Interventions (SCAI) 2021 Scientific Sessions.

The findings reveal inequitable access to TAVR programs for non-metropolitan or lower income areas across the country. Between 2012 and 2018, 554 hospitals developed new TAVR programs including 543 (98%) in metropolitan areas, and 293 (52.9%) in metropolitan areas with pre-existing TAVR programs. Compared with hospitals that did not start TAVR programs, hospitals that did start TAVR programs treated patients with higher median household incomes (difference $1,305, 95% CI $134 to $12,477, p=0.03). Furthermore, TAVR rates per 100,000 Medicare beneficiaries were higher in areas with higher median income, despite adjusting for age and clinical comorbidities.

The authors also acknowledge that increasing access to TAVR and structural heart programs will require foresight into how clinical trials and approval for procedures and technologies at hospitals are distributed.

Read more about this study

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Cindy Grines, M.D., MSCAI, FACC, president of the Society for Cardiovascular Angiography and Interventions (SCAI), and chief scientific officer of the Northside Cardiovascular Institute in Atlanta, explains a survey showing patients fear catching COVID-19 more than heart attacks. The SCAI survey found this fear is now seen as playing a role in preventing people from going to the hospital if they do have a heart attack or stroke, or even seeing their doctors for checkups or for cardiac complaints they might be having. This is leading to an increase in patients showing up very late after the onset of heart attacks, leading to serious cardiac damage and worse outcomes.  This was a concern early on in the U.S. spread of the virus, but this recent survey shows patients attitudes and fears have not improved much since last spring.
 

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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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Aaron Baggish, M.D., director of the cardiovascular performance program, Massachusetts General Hospital. He was on a 2020 American Heart Association (AHA) meeting panel discussion on the topic of the lingering myocardial involvement after COVID-19 (SARS-CoV-2) infection. He said there appears to be some long-term effects in the body from COVID, including the heart and vascular system, but it is unknown how long these effects may last. These patients are now being referred to as COVID "long-haulers."

The AHA late-breaking studies included four that pertained specifically to COVID-19. Three of these pertained specifically to the AHA COVID-19 Cardiovascular Disease Registry. It has been collecting data on patients with cardiac co-morbiditities or cardiac involvement since April to provide insights into these patients hospitalized with the novel coronavirus. One study was a review of the registry, a second looked at the racial and ethnic disparities in severe COVID patients. The third looked at the association of body mass index and death, mechanical ventilation and cardiovascular outcomes.

Read more about these three studies in the article COVID-19 Cardiovascular Registry Details Disparities Among Hospitalized Patients.

The fourth study looked at the overall of cardiovascular risk factors in more than 14,000 COVID-19 patients. It showed in-hospital mortality ranged from 28.5 percent for patients with hypertension to 28.6 percent for those with diabetes, 25.5 percent for those with coronary artery disease, and 38.4 percent for those with heart failure.

Read more in the article COVID-19 Patients With Cardiovascular Disease Have In-hospital Mortality Rates of 25 to 38 Percent. 

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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

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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