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VIDEO: Advances in Congenital Heart Therapy Technologies

Congenital Heart | May 26, 2021

Tom Jones, M.D., director, cardiac catheterization laboratories, Seattle Children’s Hospital, explains some of the new technologies being used to treat congenital heart disease. He discusses the recent trial he served as principle investigator for the new Harmony transcatheter pulmonary valve, the development of a bioresorbable transcatheter septal occluder device, development of large bioresorbable stents for use in pediatric cases, and use of virtual and augmented reality to better understand and guide very complex congenital heart procedures. Jones also explains a patient case where a 3-D printed heart and vessels from the patient helped the heart team understand all the options and how to tackle a valve replacement in a child with a single ventricle.

Jones shared some of these advances in congenital heart intervention sessions at the Society of Cardiovascular Angiography and Interventions (SCAI) 2021 meeting. 

 

Recent Technology Advances in Congenital Heart:

FDA Clears First Device to Treat Right Ventricular Outflow Tract Congenital Heart Disease 

VIDEO: Harmony Transcatheter Pulmonary Valve Has Good Outcomes at 1 Year — Interview with Tom Jones, M.D.

Medtronic Harmony Transcatheter Pulmonary Valve Demonstrates Positive Early Clinical Outcomes at One Year

FDA Expands Indication for Melody Transcatheter Valve for Failed Surgical Valves

VIDEO: Use of Virtual Reality to Aid Congenital Heart Disease — Interview with David M. Axelrod, M.D.

 

Bioresorbable Pulmonary Valve Replacement May Enable Cardiovascular Regeneration

VIDEO: Transcatheter Closure of Holes in the Heart — Interview with Ziyad Hijazi, M.D.

Nemours Children's Health System Uses 3-D Printing to Deliver Personalized Care

Children's Hospital Los Angeles Cardiologist Creates Modified Stent for 18-month-old Using Printed 3-D Model

PolyVascular Awarded $2 Million Small Business Innovation Research Grant to Bring the First Polymer-Based Heart Valve for Children to Clinical Trials

 

Bioresorbable ASD Occluder Prepares to Enter U.S. Clinical Trial

FDA Approves Abbott's Amplatzer Piccolo Occluder

Critical Need for Pediatric Electrophysiology Devices is Focus of Medical Device Competition 

Lab-created Heart Valves Can Grow With the Patient

SCAI Issues Position Statement on Adult Congenital Cardiac Interventional Training, Competencies and Organizational Recommendations

 

Abbott Receives European CE Mark for Two Pediatric Heart Devices

ASE Releases Guidelines for Transesophageal Echo in Congenital Heart Disease

Find more congenital heart disease (CHD) content

Recent Video

Congenital Heart | May 26, 2021

Tom Jones, M.D., director, cardiac catheterization laboratories, Seattle Children’s Hospital, explains some of the new technologies being used to treat congenital heart disease. He discusses the recent trial he served as principle investigator for the new Harmony transcatheter pulmonary valve, the development of a bioresorbable transcatheter septal occluder device, development of large bioresorbable stents for use in pediatric cases, and use of virtual and augmented reality to better understand and guide very complex congenital heart procedures. Jones also explains a patient case where a 3-D printed heart and vessels from the patient helped the heart team understand all the options and how to tackle a valve replacement in a child with a single ventricle.

Jones shared some of these advances in congenital heart intervention sessions at the Society of Cardiovascular Angiography and Interventions (SCAI) 2021 meeting. 

 

Recent Technology Advances in Congenital Heart:

FDA Clears First Device to Treat Right Ventricular Outflow Tract Congenital Heart Disease 

VIDEO: Harmony Transcatheter Pulmonary Valve Has Good Outcomes at 1 Year — Interview with Tom Jones, M.D.

Medtronic Harmony Transcatheter Pulmonary Valve Demonstrates Positive Early Clinical Outcomes at One Year

FDA Expands Indication for Melody Transcatheter Valve for Failed Surgical Valves

VIDEO: Use of Virtual Reality to Aid Congenital Heart Disease — Interview with David M. Axelrod, M.D.

 

Bioresorbable Pulmonary Valve Replacement May Enable Cardiovascular Regeneration

VIDEO: Transcatheter Closure of Holes in the Heart — Interview with Ziyad Hijazi, M.D.

Nemours Children's Health System Uses 3-D Printing to Deliver Personalized Care

Children's Hospital Los Angeles Cardiologist Creates Modified Stent for 18-month-old Using Printed 3-D Model

PolyVascular Awarded $2 Million Small Business Innovation Research Grant to Bring the First Polymer-Based Heart Valve for Children to Clinical Trials

 

Bioresorbable ASD Occluder Prepares to Enter U.S. Clinical Trial

FDA Approves Abbott's Amplatzer Piccolo Occluder

Critical Need for Pediatric Electrophysiology Devices is Focus of Medical Device Competition 

Lab-created Heart Valves Can Grow With the Patient

SCAI Issues Position Statement on Adult Congenital Cardiac Interventional Training, Competencies and Organizational Recommendations

 

Abbott Receives European CE Mark for Two Pediatric Heart Devices

ASE Releases Guidelines for Transesophageal Echo in Congenital Heart Disease

Find more congenital heart disease (CHD) content

Robotic Systems | May 18, 2021

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. 

 

Related Robots in the Cath Lab Content:

VIDEO: Robotic PCI Performed Well in Real-World Population in the PRECISION GRX Study — Ehtisham Mahmud, M.D.

Second Generation Robotic PCI System Performs Well Across Spectrum of Lesion Complexity

VIDEO: Standardizing PCI Through Smart Robotic Procedural Automation

Corindus Launches technIQ 1 Smart Procedural Automation Series for CorPath GRX Cath lab Robotic System

FDA Clears Corindus CorPath GRX for Peripheral Vascular Interventions

VIDEO: Corindus CorPath Robotic PCI System For The Cardiac Cath Lab

Corindus CorPath Used in World's First-in-Human Telerobotic Coronary Intervention

14 Ways to Reduce Radiation Exposure in the Cath Lab

Corindus Seeking Neurovascular Intervention Clearance for CorPath GRX Vascular Robotic System

Innovations Driving the Cath Lab Technology of Tomorrow

Siemens Completes Acquisition of Cath Lab Robotics Vendor Corindus

First Robotic Coronary Angioplasties Performed With Robocath System in Germany

Hoag Performs First Robotic Carotid Artery Stenting on West Coast
 

Find more news from the SCAI 2021 virtual meeting

 

 

Robotic Systems | May 18, 2021

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

 

Related Robots in the Cath Lab Content:

VIDEO: Standardizing PCI Through Smart Robotic Procedural Automation

Corindus Launches technIQ 1 Smart Procedural Automation Series for CorPath GRX Cath lab Robotic System

FDA Clears Corindus CorPath GRX for Peripheral Vascular Interventions

VIDEO: Corindus CorPath Robotic PCI System For The Cardiac Cath Lab

Corindus CorPath Used in World's First-in-Human Telerobotic Coronary Intervention

14 Ways to Reduce Radiation Exposure in the Cath Lab

Corindus Seeking Neurovascular Intervention Clearance for CorPath GRX Vascular Robotic System

Innovations Driving the Cath Lab Technology of Tomorrow

Siemens Completes Acquisition of Cath Lab Robotics Vendor Corindus

First Robotic Coronary Angioplasties Performed With Robocath System in Germany

Hoag Performs First Robotic Carotid Artery Stenting on West Coast
 

Find more news from the SCAI 2021 virtual meeting

Structural Heart | May 13, 2021

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. 
 

Related Pulmonary Valve Content:

FDA Clears First Device to Treat Right Ventricular Outflow Tract Congenital Heart Disease 

FDA Clears Sapien for Pulmonary Valve

Medtronic Harmony Transcatheter Pulmonary Valve Demonstrates Positive Early Clinical Outcomes at One Year

Medtronic Shares Two-Year Harmony Transcatheter Pulmonary Valve Results

FDA Expands Indication for Melody Transcatheter Valve for Failed Surgical Valves

Find more congenital heart disease (CHD) content

Structural Heart | May 10, 2021

Philippe Géneréux, M.D., director of the structural heart program at Atlantic Health System’s Morristown Medical Center, is the lead author of the new VARC-3 consensus document that defines endpoints and standardizes taxonomy for aortic valve research.[1] This document is important because it acts as a guide so all structural heart research is comparable and using the same terminology. He said this will become more important as long-term outcomes of 5 to 10 years become available and require apples-to-apples comparisons with newer valve technologies.

Key updates in VARC-3 include a new section on hospitalization or re-hospitalization, defining various levels of valve leaflet thrombosis, also known as hypo-attenuated leaflet thickening (HALT), and defining the stages of bio-prosthetic valve deterioration and valve failure. 

The Valve Academic Research Consortium (VARC), founded in 2010, was intended to identify appropriate clinical endpoints and standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.

Reference:

1. VARC-3 WRITING COMMITTEE: PhilippeGénéreux, Nicolo Piazza, Maria C. Aluc, Tamim Nazif, Rebecca T.Hahn, Philippe Pibarot, Jeroen J. Bax, Jonathon A.Leipsic, Philipp Blanke, Eugene H.Blackstone, Matthew T.Finn, Samir Kapadia, Axel Linke, Michael J.Mack, Raj Makkar, Roxana Mehranl, Jeffrey J. Popmam, Martin B.Leon, et al. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. Journal of the American College of Cardiology. Available online 19 April 2021. https://doi.org/10.1016/j.jacc.2021.02.038.

 

Radial Access | May 06, 2021

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

Coronavirus (COVID-19) | May 06, 2021

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

SCAI 2021 Late-breaking Clinical Study Results

Find more news from the SCAI 2021 virtual meeting

 

Cath Lab | May 05, 2021

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

Structural Heart | April 30, 2021

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

Find more news from the SCAI 2021 virtual meeting

Cardiogenic Shock | April 28, 2021

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

 

Related Cardiogenic Shock Content:

VIDEO: How to Reduce Cardiogenic Shock Mortality by 50 Percent — Interview with h Babar Basir, D.O.

SCAI Releases New Consensus Document on Classification Stages of Cardiogenic Shock

VIDEO: The Importance of Ventricular Unloading in AMI and Cardiogenic Shock — Interview with Nevin Kapur, M.D.

VIDEO: Cardiogenic Shock Initiative Continues to Reduce Mortality by 50 Percent — Interview with William O’Neill, M.D.

10 Reasons Why it is Time to Learn More About Cardiogenic Shock — by Emmanouil S. Brilakis, M.D.

New Approaches to Reduce Cardiogenic Shock Mortality

VIDEO: Overview of the National Cardiogenic Shock Initiative — Interview with William O’Neill, M.D.

Cath Lab | April 02, 2021

Corindus, a Siemens Healthineers company and a developer of vascular robotics, recently launched a new set of automated robotic movements in the technIQ Series designed for the CorPath GRX System.

Kate Drake, director of marketing for Corindus, talks with DAIC Editor Dave Fornell about how this software automation provides advanced device manipulation during complex coronary and peripheral procedures in the cath lab.

Corindus has added automated movements for catheter spin, wiggle, dotter and constant speed to help navigate tight lesions and tortuous anatomy.

Drake also discusses the first use of telerobotic procedures with the Corindus system, where the operator was 32 km away from their patient.

For more information: Corindus.com 

 

Related Corindus Robotic System Content:

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

Final Results of the Multicenter PRECISION GRX Study of the CorPath in a real-world population across a spectrum of lesion complexity — SCAI 2021 late-breaker

Corindus Vascular Robotics to Be Acquired by Siemens Healthineers

Corindus CorPath GRX Used in Live Complex Robotic-Assisted Coronary Intervention at EuroPCR 2019

Reducing Physician Radiation Dose With Robotics

Corindus Seeking Neurovascular Intervention Clearance for CorPath GRX Vascular Robotic System

Corindus CorPath Used in World's First-in-Human Telerobotic Coronary Intervention

Hoag Performs First Robotic Carotid Artery Stenting on West Coast

Find more information on robotic systems for the cath and EP labs

Coronavirus (COVID-19) | April 01, 2021

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

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

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

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

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

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

Find more COVID cardiology related news and video

 

Point-of-Care Ultrasound (POCUS) | April 01, 2021

Here are two quick clinical examples of point-of-care ultrasound (POCUS) lung imaging and cardiac imaging using a GE Vscan Air device. The examples show an abnormal lung image with B-lines. The second clip shows a healthy heart in a parasternal color Doppler image.

The GE Healthcare Vscan Air is a cutting-edge, wireless pocket-sized ultrasound that provides crystal clear image quality, whole-body scanning capabilities, and intuitive software. The pocket-sized ultrasound system was originally introduced in 2010, and as of early 2021, there are over 30,000 Vscan systems in use. The new Vscan Air features a wireless ultrasound probe.

Read more in the article GE Healthcare Unveils Vscan Air Wireless Handheld Ultrasound

Find more POCUS news and video

Cath Lab | March 31, 2021

This is a quick example of clinical use of the Shockwave Medical Intravascular Lithotripsy system that uses sonic wave pulses and a low pressure 4 atm compliant balloon to break up heavy calcium without vessel trauma. Intravascular lithotripsy gained FDA clearance for peripheral artery disease (PAD) in 2016, and the company began working toward an additional indication for the coronaries. It was granted FDA clearance in February 2021. The FDA also recognized this technology as a breakthrough technology because it offers a solution to a long-standing clinical problem.

Related Intravascular Lithotripsy Content:

FDA Clears Coronary Intravascular Lithotripsy to Breakup Calcified Lesions With Sound Waves 

VIDEO: Intravascular Lithotripsy to Treat Severely Calcified Coronary Artery Lesions — Interview with Dean Kereiakes, M.D.

Intravascular Lithotripsy: Will This New Investigational Technology Crack Calcium’s Code in the U.S.? — Article by DISRUPT CAD III investigators  Dean Kereiakes, M.D., and Jonathan Hill, M.D.

FDA Grants Shockwave Medical Breakthrough Status for Coronary Intravascular Lithotripsy

 

BLOG: Coronary Lithotripsy May Become a Paradigm Shift in the Cath Lab

VIDEO: Breaking Up Calcified Lesions Without Vessel Trauma — Interview with Todd Brinton, M.D.

FDA Clears Lithoplasty Balloon That Shatters Calcified PAD Lesions With Ultrasound

Lithotripsy Safe and Effective in Calcified Stenotic Peripheral Arteries

 

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

VIDEO: How a Lithoplasty Balloon Shatters Calcified Plaque in Arteries With Ultrasound

 VIDEO: Demonstration of Intravascular Lithotripsy Breaking Up Calcium.

Structural Heart | March 23, 2021

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

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

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

Related PFO Closure Content:

VIDEO: How Transcatheter PFO Closure Can Reduce Cryptogenic Stroke — Interview with John Rhodes, M.D.

Gore Cardioform ASD Occluder Receives FDA Approval

VIDEO: Transcatheter PFO Closure to Prevent Stroke and Migraines — Interview with Carey Kimmelstiel, M.D.

SCAI Offers Recommendations for Safe Use of PFO Closure Technologies

VIDEO: An Overview of PFO Closure to Treat Cryptogenic Stroke — Interview with Karen Orjuela, M.D.

VIDEO: Demonstration of a Transcatheter PFO Occluder Implantation

VIDEO: Transcatheter Closure of Holes in the Heart — Interview with Ziyad Hijazi, M.D.

PFO Closure Shows Positive Results from REDUCE Clinical Study

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

 

Reference:

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

 

Ventricular Assist Devices (VAD) | March 22, 2021

Surgeons at Penn State Heart and Vascular Institute were the second group in the nation to implant a newly-designed mechanical pump in a patient with severe heart failure. The EvaHeart2 Left Ventricular Assist System (LVAD), can be used as a destination therapy and as a bridge to transplant.

Rob Dowling, M.D., director of heart device research at Penn State Heart and Vascular Institute and Penn State College of Medicine, explains the benefits of the new  LVAD system. He was one of the cardiothoracic surgeons who implanted the pump and said the EvaHeart2 left ventricular assist system was designed to reduce the risk of post-implantation stroke, which affects approximately 8% of heart failure patients implanted with an LVAD.

The flush inflow ostium in the left ventricle, low profile inflow design, rotational apex suture cuff are designed to be forgiving on possible inflow cannula malposition and to minimize the risk of wedge thrombus.

“Imagine inserting the tip of a vacuum cleaner into the left ventricle of the heart to get the blood to the pump and out to the rest of the body,” Dowling said. “Sometimes the tip can move into an incorrect position even after proper surgical placement and can create suction against the walls of the heart. This may create blood clots that could cause strokes. This new device was designed in such a way that there is no tip, but rather the “vacuum” hose itself is surgically attached directly to into the lining of the walls of the heart, removing the need for a tip and thereby potentially reducing the risk of stroke.”

The procedure was part of the COMPETENCE Trial, a multi-center clinical study to evaluate EvaHeart2 that will include 40 clinical sites and 399 patients with severe heart failure through 2022.

Richard Huggins, 75, of Lock Haven, Pa., was the second patient in the nation to receive the EvaHeart2 Left Ventricular Assist System (LVAS). Surgeons at Penn State Heart and Vascular Institute implanted the device on Jan. 13.

Read more in the article Hershey Medical Center Second in the Nation to Implant EvaHeart2 LVAD.

 

ECMO Systems | February 16, 2021

An emotional reunion with COVID-19 patient Crystal Gutierrez and the clinicians and cardiologist who saved her life at HCA Houston Healthcare Medical Center and Houston Heart. Gutierrez, a young mother who earlier in 2020 fell seriously ill from the effects of COVID-19 after delivering her son Matthew, spent 152 days in the hospital fighting again and recovering from COVID. Due to profound respiratory failure, she was put on extracorporeal membrane oxygenation (ECMO) therapy to take over the oxygenation of her blood from the lungs, and to unload the work of the heart by circulating her blood. The ECMO procedure was performed by Keshava Rajagopal, M.D., Ph.D., at Houston Heart.

Crystal was reunited February 12, 2021, with the doctors and nurses of HCA Houston Healthcare Medical Center and Houston Heart who helped to save her life. 

DAIC's focus is coverage of cardiovascular technologies like ECMO, but this video drives home the message that these technologies are used to save lives and the work by clinicians and cardiologists has a profound effect on patients and their families. This is an impact is often academic in discussion and is rarely seen by people who do not work directly with patients in hospitals. 

Many hospitals now "clap out" severe COVID patients at discharge. It has become a sort of rite of passage in honor of these patients overcoming adversity and surviving a very dangerous bout with the pandemic virus. It is also often a moral boost to clinicians who participate, having helped the patient fight and survive. 

As of the publication of this video on DAIC Feb. 16, 2021, more than 487,000 Americans have died from the COVID-19. Worldwide there have been more than 2.41 million deaths.

Read more in the article COVID Mother Reunited With Caregivers After Saving Her Live With ECMO.
 

Related ECMO Use in COVID-19 Content:

FDA Approves ECMO to Treat COVID-19 Patients

VIDEO: ECMO Support Effective in Sickest COVID-19 Patients — Interview with Ryan Barbaro, M.D.

ECMO Used to Treat Adult Respiratory Distress Syndrome Case

ECMO Support Found Effective in Sickest of COVID-19 Patients

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

 

Cath Lab | February 04, 2021

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.
 

SCAI Study Shows COVID Fears Continue to Cause Americans to Avoid Doctor Visits

VIDEO: Where Have all the STEMI Cases Gone Amid COVID-19? — Interview with Thomas Maddox, M.D.

Rapid Drop in Heart Attacks and Stroke at Hospitals Concerns ACC 

Find more cardiology related COVID content

EP Device Monitoring Systems | December 22, 2020

Robert Kowal, M.D., chief medical officer of the Medtronic cardiac rhythm and heart failure division, said there has been a large increase in interest in remote monitoring and programing capabilities of implantable electrophysiology (EP) devices since the start of the COVID-19 pandemic. 

Cardiologists are looking for ways to care for their patients without the need to have them come into the office for close, personal meetings and interrogation of their implanted EP devices. Remote monitoring of these devices has been around for a decade and the Heart Rhythm Society (HRS) urged use of this technology in a 2015 consensus statemement. However, it has been COVID that has really pushed clinicians and patients to use this technolgy to its fullest as a way to watch patients closely from a distance and not require them to have to come into the office. It also enables EP practices to reprogram devices or alerts remotely where ever the have access to an internet connection. 

Find more EP news and video

FFR Technologies | December 16, 2020

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 

Robotic Systems | December 16, 2020

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 

 

 

Related Cardiovascular Robotics Content:

VIDEO: Standardizing PCI Through Smart Robotic Procedural Automation

Final Results of the Multicenter PRECISION GRX Study of the CorPath in a real-world population across a spectrum of lesion complexity — SCAI 2021 late-breaker

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

Robocath Successfully Carries Out First Robotic Coronary Angioplasties in Humans

Corindus Vascular Robotics to Be Acquired by Siemens Healthineers

Corindus CorPath GRX Used in Live Complex Robotic-Assisted Coronary Intervention at EuroPCR 2019

Stereotaxis Announces Next-generation Robotic Magnetic Navigation and Imaging Systems

Reducing Physician Radiation Dose With Robotics

Corindus Seeking Neurovascular Intervention Clearance for CorPath GRX Vascular Robotic System

Corindus CorPath Used in World's First-in-Human Telerobotic Coronary Intervention

Robots in the Cath Lab

 

Coronavirus (COVID-19) | December 07, 2020

Todd Hurst, M.D., a cardiologist at Banner University Medicine Heart Institute, and an associate professor at the University of Arizona, explains some of the long-term COVID-19 (SARS-CoV-2) post-infection cardiovascular impacts. 

After the coronavirus is gone, many COVID-19 patients are finding they have long-term problems with shortness of breath, arrhythmias, fatigue and cognitive issues. Clinicians are now referring to these patients as "long-hauler" COVID patients. COVID is known to cause myocarditis in many seriously ill patients, but post mortal studies of COVID patients also show the virus kills heart cells and the long term impact of this is not yet known.

VIDEO: Lingering Myocardial Involvement After COVID-19 Infection — Interview with Aaron Baggish, M.D.
 

 

EP Lab | December 04, 2020

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).

 

Related EP Ablation Technology Content:

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.

Biotronik Partners With Acutus Medical to Offer More Efficient Arrhythmia Diagnosis and Treatment

Contact Force Sensing Catheter Improved Outcomes in Persistent Atrial Fibrillation Ablation

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

 

Coronavirus (COVID-19) | November 18, 2020

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. 

Find more AHA news, video, and late-breakers

VIDEO: What Are The Long-term Cardiac Impacts of COVID-19 Infection — Interview with Todd Hurst, M.D.

Find more cardiology related COVID-19 news

 

 

 

Atrial Fibrillation | November 18, 2020

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

Coronavirus (COVID-19) | November 12, 2020

Eric Gantwerker, M.D., vice president and medical director at clinical video game simulator company Level Ex, and associate professor, Department of Otolaryngology Head and Neck Surgery at Loyola University, explains a smartphone video game simulator to help clinicians become more proficient in diagnosing and managing COVID-19 (SARS-CoV-2) patients. Level Ex has created video game modules for interventional cardiology and is expanding this to cardiovascular complications in COVID patients, based on real patient case studies.

The app offers several patient cases where the player can decide what questions to ask the patient or tests to perform, but the player is limited in the number of actions they can take. The app offers several potential reasons for the patient's presentation that may, or may not, be COVID and the player needs to take clinical actions to eliminate other disease possibilities from the list. Management of COVID cases with cardiac complications are also offered to test a clinician's ability to keep the patient stable and enable discharge.

Related Content:

IVUS and iFR Video Game App Training Offered by Philips and Level Ex

Video Game Format Used to Train Cardiologists

 

 

 

Coronavirus (COVID-19) | November 10, 2020

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.

 

Related Cardiac COVID-19 Content:

COVID-19 Positive STEMI Patients Have Higher Mortality 

VIDEO: ECMO Hemodynamic Support Effective in Sickest COVID-19 Patients — Interview with Ryan Barbaro, M.D.

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.  

VIDEO: Telemedicine in Cardiology and Medical Imaging During COVID-19 — Interview with Regina Druz, M.D.

VIDEO: COVID-19 Precautions for Cardiac Imaging — Interview with Stephen Bloom, M.D.,

Find more cardiology related COVID-19 content

 

Hemodynamic Support Devices | October 20, 2020

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

Coronavirus (COVID-19) | October 20, 2020

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

Find more cardiology related COVID news 

 

Cath Lab | October 19, 2020

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

Antiplatelet and Anticoagulation Therapies | October 19, 2020

The COMPARE CRUSH Trial looked at the effect of pre-hospital crushed prasugrel tablets in patients with STEMI planned for primary percutaneous coronary intervention (PCI).[1] This video is of the press conference presentation 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 antiplatelet 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.

 

Stents Drug Eluting | October 19, 2020

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

 

 

 

Heart Valve Technology | October 19, 2020

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

 

Related TAVR Content:

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

 

Antiplatelet and Anticoagulation Therapies | October 19, 2020

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

 

 

Heart Valve Technology | October 19, 2020

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

 

Related TAVR Content:

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

 

Antiplatelet and Anticoagulation Therapies | October 17, 2020

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

Cath Lab | October 17, 2020

Gregg Stone, M.D., presents the results of the PROSPECT ABSORB Trial in a press conference at the 2020 Transcatheter Cardiovascular Therapeutics (TCT) Connect virtual meeting. 

The PROSPECT ABSORB Trial was a randomized evaluation of vulnerable plaques using the Abbott Absorb fully bioresorbable stent. The hypothesis of the trial  was to treat lesions prior to plaque ruptured to avoid heart attacks, rather than treating them after plaque rupture when a potential infarct and permanent heart damage is caused. Patients were randomized to percutaneous coronary intervention (PCI) using an Absorb bioresorbable vascular scaffold (BVS) stents vs. guideline directed medical therapy (GDMT).

This is the first study that proactively identifies and preemptively treats vulnerable plaques. 

Lesion related MACE events 4 years showed medical therapy alone resulted in 10.7 percent events and the BVS treat patients were 4.3 percent. Stone said the favorable BVS MACE rates warrants a larger, adequately powered randomized trial to determine if PCI treatment of focal vulnerable plaques improves patient outcomes.

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

 

Heart Failure | October 16, 2020

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.

 

Cath Lab | October 16, 2020

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.

 

Related Content on Intervascular Lithotripsy:

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

Shockwave Technology to Sonically Bust Calcified Coronary Lesions Shows Safety and Efficacy in U.S. Pivotal IDE Trial

FDA Grants Shockwave Medical Breakthrough Status for Coronary Intravascular Lithotripsy

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.

VIDEO: Breaking Up Calcified Lesions Without Vessel Trauma — Interview with Todd Brinton, M.D.

Shockwave Launches Coronary Intravascular Lithotripsy in Europe

Lithotripsy Safe and Effective in Calcified Stenotic Peripheral Arteries

Shockwave Initiates U.S. Pivotal Study for Coronary Intravascular Lithotripsy

Radial Access | October 07, 2020

Jordan G. Safirstein, M.D., FACC, FSCAI, director of transradial catheterization for Atlantic Health System’s Morristown Medical Center, Morristown, N.J., explains the new radial access lounge at the Gagnon Cardiovascular Institute.

Transradial 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. 

Patients can walk around, use the washroom, get coffee and sit in lounge chairs for their recovery while being monitored via wireless telemetry. This is a stark contrast to the transfemoral artery access recovery, which requires six hours of bed rest and can be very uncomfortable for the patient.

“Nearly half of all cardiac catheterizations are now done transradially, and there is plenty of data to show it is very safe and can be done as an outpatient procedure” Safirstein explained. “We saw the need for a recovery area for these patients that was more comfortable.  These patients don’t need a traditional recovery room. Our goal is to safely send patients home on the same day of their procedure but while they spend time with us, it should be time spent relaxing, reading, receiving education about their procedure and prevention of future events. If they need new medications, we can provide that to them before they leave.”

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

 

Related Transradial Access Content:

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.

 

VIDEO: Radial Access Lounge Walk Through at Morristown Medical Center

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

VIDEO: Update on U.S. Transradial Access Adoption — an interview with Sunil Rao, M.D.

VIDEO: Trends in Radial Access for Percutaneous Coronary Interventions — Interview with Sunil Rao, M.D., and Prashant Kaul, M.D.

 

Transradial Access Celebrates 25 Years

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