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.

Find more COVID-19 news and video

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Find more news from the SCAI 2021 virtual meeting

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

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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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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 periperal vessels. The system uses sonic waves that penetrate the vessel wall and crack the calcium without causing vessel trauma, which commonly occures 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 gypsym 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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Juan F. Granada, M.D., CEO of the Cardiovascular Research Foundation (CRF) explains structural heart innovations and new technologies have exploded in the past few years after the success of transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair (TMVR) with the MitraClip. 

Granada said device technologies in development for interventional heart failure therapies, mitral valve and tricuspid replacements and repairs have grown rapidly in just the past couple years. He said the Transcatheter Cardiovascular Therapies (TCT) 2020 received a very large number of presentation proposals for new structural heart innovations.

Hear more about the TCT 2020 virtual meeting in the VIDEO: What to Expect at the Virtual TCT 2020 Meeting, an interview with Juan Granada.

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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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