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

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

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

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

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

Find links to all the TCT 2021 late-breakers

Find more TCT news

Dr. Neil Moat, MBBS, chief medical officer of Abbott's structural heart business, was a cardiac surgeon specializing in the mitral valve prior to taking on his current role where he oversees Abbott's advancements in transcatheter valve technologies. 

He explains some of the evolution in the industry as surgical repairs now are offered side-by-side with transcatheter valve replacement and repair technologies. He notes that the number of heart valve patients being treated has increased with the introduction of transcatheter technologies, and that surgical volumes have not been impacted as much as people thing because more patients overall are now being treated for valve disease.

Related Transcatheter Valve Trends Content:

TAVR Expected to See Rapid Growth in Next 5 years

FDA Approves TAVR for Low-risk Patients Creates A Paradigm Shift in Cardiology

VIDEO: The Expansion of TAVR Following the FDA Clearing its Use in All Patients — Interview with Torsten Vahl, M.D.

VIDEO: Overview of the TAVR Program at Tufts Medical Center — Interview with Andrew Weintraub, M.D.

VIDEO: Tracking Transcatheter Valve Outcomes in the STS-ACC TVT Registry — John Carroll, M.D.

VIDEO: Overview of University of Colorado Structural Heart Program — Interview with John Carroll, M.D., Robert Quaife, M.D., and James Chen, Ph.D.

VIDEO: Abbott Structural Heart Technology Advances in 2021  — Interview with Neil Moat, MBBS
 

Tom Jones, M.D., director, cardiac cath labs, Seattle Children’s Hospital, and principle investigator of the Medtronic Harmony transcatheter pulmonary valve trial, explains the differences between the Melody and Harmony valves. He also explains the history of congenital heart transcatheter valve development over the past 20 years and how adult structural heart devices also developed side-by-side with these devices. 

Patients with tetralogy of fallot often received the ventricular outflow tract (RVOT) in an initial surgery and a second surgery in needed later for a pulmonary valve. As valves wear out, additional open heart surgeries are needed. The Harmony and Melody help reduce the number of open heart surgeries in these patients. Jones said the Harmony valve may help reduce or eliminate the need for open heart surgeries.

The Melody was the first transcatheter valve to gain approval for use in the United States. It was designed to treat patients who already had a surgically placed RVOT. The Harmony valve was then developed to address patients who also needed the RVOT. Between the two valves, Jones said the majority of congenital heart issues can now be treat.

Jones said about 40,000-50,000 babies are born each year in the United States with congenital heart defects that the Harmony and Melody valves might be used to help. He said the Melody valve was able to help about 25% of these patients, and the Harmony valve now can help the rest of these patients with a transcatheter solution. 
 

Related Congenital Heart Content:

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

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

FDA Expands Indication for Melody Transcatheter Valve for Failed Surgical Valves

VIDEO: The Heart Team Approach in Congenital Structural Heart Interventions — Interview with Tom Jones, M.D.

VIDEO: Advances in Congenital Heart Therapy Technologies — Interview with Tom Jones, M.D.

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

Medtronic Shares Two-Year Harmony Transcatheter Pulmonary Valve Results

Find more congenital heart disease (CHD) content

Tom Jones, M.D., director, cardiac cath labs, Seattle Children’s Hospital, explains the importance of the heart team approach on congenital heart interventions and explains the development of adult congenital interventional specialists. Jones explains the role of pediatric and adult congenital interventionists and structural heart specialists and the importance of the team approach with complex congenital heart patient cases.

He also explains the history of interventions and congenital heart disease over the last few decades and how these helped shape transcatheter adult structural heart interventions today. 

Related Congenital Heart Content:

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

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

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

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

Ehtisham Mahmud, M.D., division chief of cardiovascular medicine, director of interventional cardiology and the cardiac cath lab at the University of California at San Diego Health, was the principle investigator for a trial that looked at the latest generation of cath lab robotics in a real-world patient population. 

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

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

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

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

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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

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.

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

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

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

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

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 

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

Chuck Simonton, M.D., chief medical officer at Abiomed, explains when advanced hemodynamic support is 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 

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

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

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

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

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

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

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

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

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

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

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

Related Content on Intervascular Lithotripsy:

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