Healthcare analytics, AI solutions for biological big data, providing an AI platform for the biotech, life sciences, medical and pharmaceutical industries, as well as for related technological approaches, i.e., curation and text analysis with machine learning and other activities related to AI applications to these industries.
Paul G. Yock, Recipient of the 2024 National Medal of Technology and Innovation, Professor of Cardiovascular Medicine at Stanford Medical School
Curator: Aviva Lev-Ari, PhD, RN
NMTI Citation
Paul G. Yock, Stanford University
For innovations in interventional cardiology. Paul Yock’s visionary work understanding the human heart is applied around the world today to improve patient care and save countless lives. His creation of the Biodesign approach to training future leaders of biotechnology and health care ensures his insights and experience will benefit generations to come.
Recipients of the 2024 National Medal of Technology and Innovation, administered by President Joe Biden and Laureates of the National Medal of Science, administered by NSF
Paul Yock – The Martha Meier Weiland Professor in the School of Medicine and Professor of Bioengineering, Cardiovascular Medicine, and (by courtesy) of Mechanical Engineering
Scientific Leadership Council Member, Clark Center Faculty
Dr. Paul Yock is the Martha Meier Weiland Professor of Medicine and founding co-chair of Stanford’s Department of Bioengineering, with courtesy appointments in the Graduate School of Business and the Department of Mechanical Engineering. He is also founder and director of the Stanford Byers Center for Biodesign.
After completing his undergraduate and graduate studies at Amherst College and Oxford, respectively, Paul received his MD from Harvard Medical School followed by internship and residency training at the University of California, San Francisco and a fellowship in cardiology at Stanford. He began his faculty career as an interventional cardiologist at UCSF and then moved to Stanford in 1994.
Paul has authored over 300 peer-reviewed publications, chapters and editorials, two textbooks, and over 50 US patents. He is internationally known for his work in inventing, developing, and testing new devices, including the Rapid Exchange™ stenting and balloon angioplasty system, which is now the primary system in use worldwide. He also invented the fundamental approach to intravascular ultrasound imaging and founded Cardiovascular Imaging Systems (CVIS), later acquired by Boston Scientific. Recent awards include the Transcatheter Therapeutics (TCT) Career Achievement Award, the American College of Cardiology Distinguished Scientist Award, and the National Academy of Engineering’s 2018 Bernard M. Gordon Prize for Innovation in Engineering and Technology Education.
Bio
Yock began his faculty career as an interventional cardiologist at UC San Francisco and then moved to Stanford in 1994. Yock is known for his work in inventing, developing and testing new devices, including the
Rapid Exchange angioplasty and stenting system, which is the primary approach used worldwide. Yock also authored the fundamental patents for
intravascular ultrasound imaging, conducted the initial clinical trials and
established the Stanford Center for Research in Cardiovascular Interventions as a core laboratory for analysis of intravascular ultrasound clinical studies. He also
invented the Smart Needle and
is a co-inventor of the strain-reduction patch for wound healing.
Yock was founding Co-Chair of the Department of Bioengineering and continues research related to new device technologies.
Yock also was the founding director of the Stanford Byers Center for Biodesign – dedicated to advanced training in medical technology innovation.
Abstract: A catheter is provided for insertion in the he blood vessel of a patient for ultrasonically imaging the vessel wall. The catheter includes a tubular element and an internally housed drive cable for effective circumferential scan about the catheter of an ultrasonic generating means. Both the tubular element and the drive cable are of a size and flexibility sufficient to permit their introduction into the vessel and subsequent advancement through the vessel to the location of the vessel wall where imaging is desired.
Abstract: Devices and methods for obtaining a three-dimensional image of an internal body site are provided. The subject devices are elongated structures (e.g., catheters) having a plurality of ultrasonic transducers located at their distal end. The configuration of the plurality of ultrasonic transducers may be reversibly changed from a first to a second configuration, where the radial aperture of the plurality of ultrasonic transducers is greater in the second configuration than in the first configuration. A feature of certain embodiments of the subject invention is that the plurality of ultrasonic tranducers are configured in the second configuration as a substantially continuous set of transducers. In using the subject imaging devices, the distal end of the devices is positioned at the internal body site of interest while the plurality of ultrasonic transducers is in the first configuration.
Type: Application
Filed: November 10, 2004
Publication date: September 29, 2005
Inventors: Richard Popp, Ali Hassan, Christian Eversull, Jeremy Johnson, Paul Yock
Abstract: Apparatus for introduction into the vessel of a patient comprising a guiding catheter adapted to be inserted into the vessel of the patient and a device adapted to be inserted into the guiding catheter. The device includes a flexible elongate member and a sleeve carried by the flexible elongate member near the distal extremity thereof and extending from a region near the distal extremity to a region spaced from the distal extremity of the flexible elongate element. The device also includes a guide wire adapted to extend through the sleeve so that the guide wire extends rearwardly of the sleeve extending alongside of and exteriorally of the flexible elongate element into a region near the proximal extremity of the flexible elongate element.
Abstract: A catheter system for localized or semi-localized administration of agents through the wall of a blood vessel is provided. Various catheter system constructions which use at least one expandable occluding device to create an isolated region are provided. Constructions using one catheter and one occlusion device are provided, along with constructions using two catheters and multiple occlusion devices. The catheter system may include a catheter with a variable stiffness along its length. The catheter system may also include a guide wire integrated with an inner catheter. The catheter can infuse the agent into the blood vessel in a pressure regulated manner. Methods for delivery and infusion of the agent within a blood vessel are also provided.
Type: Application
Filed: February 20, 2004
Publication date: March 17, 2005
Inventors: Michi Garrison, Todd Brinton, Peter Campbell, Steve Roe, Stephen Salmon, Paul Yock
Abstract: Apparatus and method are described for introducing an imaging catheter to the coronary vasculature. A guiding catheter is introduced so that the distal end of the guiding catheter engages a coronary os. The distal end of the guiding catheter is shaped so that a mark on the distal end is oriented in a predetermined orientation relative to the coronary vasculature. An imaging catheter is then introduced through the guiding catheter and an image of the mark is produced with the imaging catheter while in the guiding catheter. In this manner, the relative orientation of the produced image and the coronary vasculature is known.
Type: Grant
Filed: October 20, 1997
Date of Patent: March 9, 1999
Assignee: Cardiovascular Imaging Systems, Inc.
Inventors: Paul Yock, Yue-Teh Jang, Stephen M. Salmon
Abstract: Apparatus and method are described for introducing an imaging catheter to the coronary vasculature. A guiding catheter is introduced so that the distal end of the guiding catheter engages a coronary os. The distal end of the guiding catheter is shaped so that a mark on the distal end is oriented in a predetermined orientation relative to the coronary vasculature. An imaging catheter is then introduced through the guiding catheter and an image of the mark is produced with the imaging catheter while in the guiding catheter. In this manner, the relative orientation of the produced image and the coronary vasculature is known.
Type: Grant
Filed: September 4, 1996
Date of Patent: March 10, 1998
Assignee: Cardiovascular Imaging Systems Inc.
Inventors: Paul Yock, Yue-Teh Jang, Stephen M. Salmon
Abstract: Apparatus and method are described for introducing an imaging catheter to the coronary vasculature. A guiding catheter is introduced so that the distal end of the guiding catheter engages a coronary os. The distal end of the guiding catheter is shaped so that a mark on the distal end is oriented in a predetermined orientation relative to the coronary vasculature. An imaging catheter is then introduced through the guiding catheter and an image of the mark is produced with the imaging catheter while in the guiding catheter. In this manner, the relative orientation of the produced image and the coronary vasculature is known.
Type: Grant
Filed: June 6, 1995
Date of Patent: January 28, 1997
Inventors: Paul Yock, Yue-Teh Jang, Stephen M. Salmon
Xenotransplantation: Pioneering a New Era of Organ Availability
Reporter: Dr. Sudipta Saha, Ph.D.
The 2024 World Medical Innovation Forum (WMIF) spotlighted xenotransplantation as a transformative solution to the organ shortage crisis. By leveraging genetically modified pig organs, this emerging field offers a new source of transplants, expanding life-saving care options.
Key breakthroughs in 2024 have brought new hope for patients, but significant hurdles remain, including immunological rejection. Ongoing research focuses on developing immunosuppressive strategies and enhancing organ compatibility.
Collaboration between scientists, clinicians, and regulatory bodies is essential for xenotransplantation’s future. Experts predict wider clinical availability within the next decade, potentially reshaping organ replacement.
This revolutionary step in organ transplantation holds promise for patients and could redefine the future of transplant care globally. Here’s a comprehensive report covering the research contributions of the panelists from the Xenotransplantation: Game Changing Organ Replacement discussion:
1. Jason Gerberry
Specialty Pharma and SMid-Cap Biotech Analyst, BofA Global Research
Gerberry is a prominent financial analyst with deep expertise in specialty pharmaceuticals and small-to-mid-cap biotechnology firms. His research focuses on investment trends, market dynamics, and the financial viability of innovative medical solutions such as xenotransplantation. At WMIF 2024, he provided insights on how breakthroughs in the field could impact the biotech sector, including the potential for significant investments driven by advancements in gene editing and organ transplantation technologies. Gerberry’s analysis offers critical perspectives on the commercial and economic landscape surrounding xenotransplantation.
2. Joren Madsen, MD, PhD
Director, MGH Transplant Center
Paul S. Russell/Warner-Lambert Professor of Surgery, Harvard Medical School Dr. Madsen is a leader in transplant surgery and immunology. His research focuses on allograft rejection and immunosuppressive strategies to enhance transplant tolerance. He has been pivotal in advancing clinical transplant practices at Massachusetts General Hospital (MGH) and has made significant contributions to xenotransplantation research by exploring how genetically engineered pig organs could help mitigate immune rejection in human recipients. Madsen’s work is key to translating laboratory findings into clinical applications.
3. Tatsuo Kawai, MD, PhD
Director of the Legorreta Center for Clinical Transplantation Tolerance
A. Benedict Cosimi Chair in Transplant Surgery, MGH
Dr. Kawai specializes in immune tolerance and organ transplantation. His research emphasizes reducing or eliminating the need for lifelong immunosuppressive drugs in transplant patients. He has led groundbreaking clinical trials on tolerance induction, paving the way for the potential acceptance of xenotransplanted organs without rejection. His research is also closely tied to immune tolerance mechanisms and how xenotransplantation can be made safer for human use.
4. Richard Pierson III, MD
Scientific Director, Center for Transplantation Sciences, MGH
Professor of Surgery, Harvard Medical School
Dr. Pierson is renowned for his work in transplantation immunology, focusing on xenotransplantation. His research addresses the fundamental problem of immune rejection of animal organs in human bodies, particularly tackling hyperacute rejection and graft survival. Dr. Pierson has been instrumental in developing strategies to overcome these barriers by modifying pig genetics and using innovative immunosuppressive therapies, which have brought the field closer to clinical application.
5. Leonardo Riella, MD, PhD
Medical Director of Kidney Transplantation, MGH
Harold and Ellen Danser Endowed Chair in Transplantation, Harvard Medical School
Dr. Riella’s research focuses on kidney transplantation and immunosuppressive therapies aimed at improving long-term graft survival. He has been a significant contributor to the field of xenotransplantation, working on improving immune tolerance and understanding how kidneys from genetically modified pigs can function in human bodies without eliciting strong immune responses. His clinical and translational research is critical for the future of xenotransplantation, particularly in renal applications.
Conclusion
These panelists represent leading voices in xenotransplantation, combining their expertise in surgery, immunology, and biotechnology to address the complex challenges of organ transplantation. Their collaborative efforts at MGH and Harvard Medical School are critical in advancing the science of xenotransplantation, bringing it closer to a clinically viable solution for the global organ shortage crisis.
“This milestone makes AISAP the first company in the world to secure FDA clearance in the CADx pathway for the comprehensive diagnosis of structural heart diseases using POCUS,”
Cardio is a cloud-based platform that includes four modules for the computer-assist diagnosis (CADx) of valvular pathologies and eight key cardiac measurements. Its advanced AI algorithms can evaluate a patient’s left ventricle ejection fraction, right and left ventricular dimensions, right ventricular fractional area change, atrial areas, ascending aorta diameter and inferior vena cava diameter in addition to identifying aortic stenosis or mitral, tricuspid or aortic regurgitation.
The platform, trained on more than 24 million echocardiography clips, was designed to help even inexperienced users scan and diagnose a majority of common heart issues within minutes without leaving the patient’s side. In addition, it can communicate with equipment manufactured by a variety of vendors, directing data to a physician’s electronic health record or PACS system as needed.
Ehud Raanani, MD, co-founder of AISAP and director of the Leviev Cardiovascular and Thoracic Center at Sheba Medical Center, said in a statement. “It marks a big step in our goal of delivering point-of-care assisted diagnosis, or POCAD, with unparalleled scalability and accessibility—from the largest academic centers to the most remote rural locations.”
Smadar Kort, MD, system director of noninvasive cardiac imaging at Stony Brook Medicine, who has experience with the platform
said:
“We know that structural heart disease and heart failure are the leading causes of hospitalization and morbidity in the U.S. Enabling a wide variety of qualified physicians to quickly and accurately diagnose these conditions at the bedside could lead to earlier detection and treatment, and better patient outcomes, as well as greater efficiencies and cost savings to health systems, while ultimately saving countless lives.”
ClotTriever XL catheter for large blood vessels, i.e., inferior vena ceva on FDA Recall
Reporter: Aviva Lev-Ari, PhD, RN
The ClotTriever XL catheter, like Inari Medical’s other ClotTriever devices, was designed to treat deep vein thrombosis. Marketed as “a large device for the largest vein,” it was built specifically to target issues found in the vena cava.
The clinical advantage of the ClotTriever system
The CLOUT registry (NCT03575364) is a prospective, single-arm study evaluating outcomes of all-comer patients with proximal lower extremity DVT after thrombectomy with the ClotTriever system. CLOUT enrolled 500 patients from 43 US clinical sites. In-hospital results demonstrated safe and effective thrombus removal with immediate symptom relief. https://www.inarimedical.com/clottriever-system
“Operation of a thrombectomy catheter may cause embolization of some thrombus and/or thrombotic particulate, physician discretion advised,” according to another new warning. “The potential for extensive and/or difficult to treat pulmonary thromboembolism should be carefully considered when ClotTriever XL catheter is used to engage and remove thrombus from large vessels such as the inferior vena cava.”
The news comes after the FDA received several reports of “serious adverse events” due to the device becoming entrapped or blocking arteries in the patient’s lungs. Six deaths and four other patient injuries have been associated with the issue so far.
Inari Medical has published updated instructions for use (IFU) that include additional warnings.
For example, the new IFU tell users to avoid pulling the ClotTriever XL “caudal to cranial” through upper extremity access or jugular vein access. In addition, users should ensure the device is “slowly retracted distally away from the heart” while still tracking sheath position and visualization under fluoroscopy.
SOURCE for Clinical Trials on the device
Dexter D, Kado H, Shaikh A, et al. Safety and effectiveness of mechanical thrombectomy from the fully enrolled multicenter, prospective CLOUT registry. J Soc Cardiovasc Angiog Interv. 2023;2(2):100585.
Shaikh A, et al. Six-month outcomes of mechanical thrombectomy for treating deep vein thrombosis: analysis from the 500-patient CLOUT registry. Cardiovasc Intervent Radiol. 2023; 46(11):1571-1580.
Tricuspid Flow Optimizer, FDA Approved, 6 months follow up of the First-in-Man Implantation in Rome, Italy
Reporter: Aviva Lev-Ari, PhD, RN
UPDATED on 10/29/2024
Innoventric Secures $28.5M and Unveils Groundbreaking Tricuspid Regurgitation Treatment to Help Patients, Many of Whom Were Previously Untreatable
Reduces Treatment Risk By Eliminating the Need for Surgical Valve Replacement and General Anesthesia – Which Ensures Shorter Operations
New York, NY — Innoventric, a leader in transcatheter tricuspid regurgitation (TR) treatment, today announced a $28.5 million Series B funding round to advance its revolutionary cross-caval technology, bringing the total funds raised since inception to $41 million. Innoventric has already successfully completed a first-in-human clinical trial in Europe, and performed many additional implantations — treating over 40 participants so far. Recently, the company received FDA clearance for an Early Feasibility Study (EFS) in the US, and patient enrollment is actively ongoing with the first US patients already treated. The funds raised will be used to advance clinical trials and expand regulatory approvals in the US and Europe.
Innoventric’s device addresses tricuspid regurgitation, a severe condition that impairs the cardiac blood flow, by replacing the native valve’s function through a heterotopic, cross-caval approach. With Innoventric, a prosthetic valve is anchored to the vena cava instead of the beating heart, so a complete seal is achieved without the risk of leakage or detachment. This method simplifies the implantation process and overcomes the anatomical complexities associated with traditional treatments. Positioned at the forefront of the $10 billion annual transcatheter heart valve replacement market, Innoventric’s technology is poised to transform tricuspid valve treatment.
The Innoventric device offers significant advantages:
Broad Patient Applicability: Designed for various anatomies, it extends treatment options to patients who are typically ineligible for tricuspid procedures.
Innovative Anchoring Technique: It anchors securely to the tubular superior vena cava (SVC) and inferior vena cava (IVC), instead of the moving heart, minimizing risks such as leakage or detachment.
Streamlined Procedure: The device can be implanted rapidly without the use of echocardiography or general anesthesia, significantly improving success rates and reducing patient recovery time.
The round was led by RA Capital Management, with new investment from the European Investment Committee (EIC). Returning investors BRM Group, JG Private Equity, and Mivtach Shamir Holdings also participated, reinforcing their confidence in Innoventric’s path-breaking technology.
Amir Danino, CEO of Innoventric, stated: “Our mission is to revolutionize tricuspid regurgitation care with minimally invasive therapies that significantly improve patient outcomes. The strong backing from our investors, coupled with the progress we’ve achieved, underscores the need and huge potential of our approach to treat TR.”
Anurag Kondapalli, Principal at RA Capital, said: “We are excited to support Innoventric as it looks to transform the approach to TR treatment. The strong outcomes from their European first-in-human trial demonstrate the immense potential of their anatomy-agnostic device to treat a broader range of patients who have lacked viable options. We have been very impressed with Innoventric’s technology and leadership, and believe their solution has the potential to reshape the future of TR care.”
Since its foundation in 2017, Innoventric has been committed to addressing the complexities of tricuspid regurgitation with its innovative transcatheter TR solutions. As leaders in cross-caval technologies, Innoventric is dedicated to the ongoing development of advanced devices to extend the reach of TR treatment. Innoventric’s approach is rigorously data-driven, with its roots grounded deep in clinical research, and its treatments are designed to benefit a broad spectrum of patients, with the aim of making high-quality care more accessible and improving health outcomes. Visit https://innoventric.com/ to learn more.
SOURCE
From: Brook Terran <brook@evergreenandoak.com> Reply-To: Brook Terran <brook@evergreenandoak.com> Date: Tuesday, October 29, 2024 at 11:39 AM To: Aviva Lev-Ari <avivalev-ari@alum.berkeley.edu> Subject: $28.5M Funding Round Solves Cardiac Issue
Tricuspid Flow Optimizer graphic courtesy of Triflo Cardiovascular.
TR – Tricuspid Regorgitation
the Tricuspid Flow Optimizer, was developed by Triflo Cardiovascular, a U.S.-based biomedical company founded in 2017 by a team of structural heart specialists.
After using CT and transesophageal echocardiography (TEE) scans to confirm the procedure was feasible, the care team implanted the device. It includes three anchors that are positioned at the tricuspid valve’s commissures. A 37 French steerable catheter was positioned in the patient’s right atrium for the implant, and the device’s positioning was “optimized” before being released. A second TEE scan confirmed the device had been successfully implanted. The patient was discharged after four days of recovery, and a permanent pacemaker was required after three weeks due to slow-rate AFib.
Six months later, the authors reported, reserve remodeling of the right ventricle and a clear improvement in TR were evident,moderate tricuspid regurgitation.
“The minimal interaction with the right cardiac chamber resulted in an easy implantation of the pacemaker; the polymer leaflets and the minimal footprint demonstrated an optimal adaptation to the native anatomy and stability through six months’ follow-up.”
The Current Impact and Future of Technology within Cardiovascular Surgery
Reporter: Arav Gandhi, Research Assistant 2, Domain Content: Cardiovascular Diseases, Series A
Medical professionals have been able to explore new methods and strategies to tackle complex medical conditions, especially with the limitations of other pre-existing conditions. For instance, through recent cardiology advancements, if the patient requires a heart transplant due to heart failure disease and is unable to undergo a human donor heart transplant as a result of pre-existing disease conditions or existing internal bleeding complications, there is a greater alternative to leaving it untreated. Medical professionals developed alternatives to humman donor transplants. One such a solution is transplanting a genetically modified pig heart, a new advanced experimental procedure that has been used over recent cases. Researchers continue to develop solutions that not only presents an alternative to current methods but also continue to maximize the potential of medical devices technology and of our understanding of medicine.
Recently, cardiologists at Henry Ford Health Hospital found themselves as the first physicians in the United States to employ an investigational device to treat a patient with severe tricuspid regurgitation. Having never been experimented upon prior to the situation, the K-Clip Transvascular Tricuspid Repair System utilizes a corkscrew anchor, which then clips the ring-shaped region of the valve. Similar to most dire situations where new technology is used, the patient, an 85-year-old male, continued to experience worsening symptoms for an entire year. His tricuspid valve, key in ensuring blood flow to the right ventricle and then to the pulmonary valve, was enlarged from his condition, resulting in the mass of his heart tripling in size. Cardiologists were then prompted to either utilize the new procedure or go untreated. With optimism, the cardiologists selected the procedure and applied a unique approach of an incision through the neck to reduce further risks of opening the chest and placed the device using real-time 3D imaging and 4D modeling. The medical professionals followed a minimally invasive procedure through the neck in contrast to traditional open-heart surgery and effectively employed recent advancements in imaging and modeling to ensure precision when planting the device, a new artificial tricuspid valve. The patient was later reported to have experience improve in the valve condition and a significant decrease in leakage, along with an improvement in his overall quality of life.
As a result, researchers should continue to focus not only on understanding undiscovered diseases and complications but also on developing alternative solutions to resolve cases in which the best practice approach can not be applied.
With the advancements in technology, the true extent of its application can not be discovered without experimentation and the application of imaging and other devices to resolve certain conditions. Beyond the technology itself, the introduction of new methods allows for less costly treatment plans, aiding especially those who come from a low-income background and currently struggle to afford basic healthcare. In the united States they are covered by MedicAid at all ages and by Medicare at age 65 and beyond. This is not the case in many countries in the World excluding Europe. The overall development of the field of medicine through advancement of medical technologies can indirectly allow for a improvement to the overall Global health care delivery and ascertain an increased life expectancies. This is primarily true, chiefly, in developing countries where established surgeries to resolve complex medical conditions still have the ability to achieve life-changing quality of life and longevity.
To learn more about the topic, check out the article below.
Chapter 13: Valve Replacement, Valve Implantation and Valve Repair
The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC
As catheter techniques evolved to compete with bypass surgery they progressed from balloon cracking of obstructive lesions (POBA=plain old balloon angioplasty) to placement of stents (wire fences). Surgeons sometimes use in-stent valves, and now devices analogous to in-stent valves can be placed by catheter for valve replacement in patients with too much co-morbidity to go through heart surgery. Aortic valve replacement by stent (TAVR) has had sufficient success to be considered for all patients who have sufficient impairment to merit intervention. The diameter is large, so a vascular surgeon participates in the arterial access and repair of the access site.
13.5 Tricuspid Valve
13.5.1 First-in-Man Mitral Valve Repairs Device used for Tricuspid Valve Repair: Cardioband used by University Hospital Zurich Heart Team
W. Gerald “Jerry” Austen, MD influential in the design and creation of a cardiopulmonary (heart-lung) bypass machine and the intra-aortic balloon pump at MGH as renowned cardiac surgeon
Curator and reporter: Aviva Lev-Ari, PhD, RN
This article is classified in the ontology of LPBI Group’s Journal PharmaceuticalIntelligence.com under the Category of Research
Interviews with Scientific Leaders
This category includes 300 articles. LPBI Group’s will publish in July 2023 its Library of Audio Podcasts on “Interviews with Scientific Leaders.”
The presentations in the video below, about W. Gerald “Jerry” Austen, MD contributions to cardiac surgery are considered to be testimonials as well as qualify as “Interviews with a Scientific Leader” in the domains of cardiac surgery and cardiac repair medical devices with a special focus on:
cardiopulmonary (heart-lung) bypass machine, and
the intra-aortic balloon pump
On these two domains, LPBI Group had published extensively as the sources cited, below: Articles, e-Books in English and Spanish and Chapters in these book on the very specialty of Dr. Austen as included in the title of this article.
Recently, Mass General celebrated the life and legacy of W. Gerald “Jerry” Austen, MD — a renowned cardiac surgeon, beloved family man and visionary leader.
SOURCE
In Memoriam: W. Gerald Austen, MD – Mass General Giving
For 70 years, Dr. Austen was part of the Mass General community, having completed his residency at the hospital and continuing to become one of the most distinguished and well-regarded physicians in the hospital’s more than 200-year history. At 39 years old, he was named Mass General’s chief of surgical services — a position he held for nearly 29 years. Under his leadership, the Department of Surgery became one of the greatest academic departments of surgery in the country. Among his many contributions, he was influential in the design and creation of a cardiopulmonary (heart-lung) bypass machine and the intra-aortic balloon pump.
Hundreds of Dr. Austen’s closest friends, colleagues and family members gathered at Boston Symphony Hall to commemorate his legacy. A variety of speakers — from current Mass General President David F. M. Brown, MD, to former hospital President Peter Slavin, MD, and retired Chairman, President and CEO of Abiomed Mike Minogue — shared fond memories of Dr. Austen, further illustrating his unmatched and lasting impact on others.
The Mass General community will continue to mourn the loss of such a giant in the medical world and will carry on Dr. Austen’s legacy through compassionate care and an unparalleled commitment to all patients.
Susan Hockfield, ex-President of MIT delivered a speech about mechanical engineering and biomedicine, medical devices and cardiac repair devices. How proud Dr. Austen was about his MIT education and functions he fulfilled for this institutions and others.
Other related contributions on the specialty of Dr.W. Gerald “Jerry” Austen, MD – cardiac surgery are covered in e-books and articles on this Open Access Online Scientific Journal, include the following:
Articles
319 articles in the Cardiac and Cardiovascular Surgical Procedures Category
98 articles in the Aortic Valve Category
Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement
Chapter 13: Valve Replacement, Valve Implantation and Valve Repair
13.2 Aortic Valve
13.2.1 New method for performing Aortic Valve Replacement: Transmural catheter procedure developed at NIH, Minimally-invasive tissue-crossing – Transcaval access, abdominal aorta and the inferior vena cava
13.2.4 Surgical Aortic Valve Replacement (SAVR) vs Transcatheter Aortic Valve Implantation (TAVI): Results Comparison for Prosthesis-Patient Mismatch (PPM) – adjusted outcomes, including mortality, heart failure (HF) rehospitalization, stroke, and quality of life, at 1 year
13.2.6 Off-Label TAVR Procedures: 1 in 10 associated with higher in-hospital 30-day mortality, 1-year mortality was similar in the Off-Label and the On-Label groups
13.2.11 One year Post-Intervention Mortality Rate: TAVR and AVR – Aortic Valve Procedures 6.7% in AVR, 11.0% in AVR with CABG, 20.7 in Transvascular (TV-TAVR) and 28.0% in Transapical (TA-TAVR) Patients
13.2.16 The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED)
Chapter 7: Ventricular Failure: Assist Devices, Surgical and Non-Surgical
7.1 Trends in the Industry
The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC
In addition to minimally invasive treatments for coronary disease and valve disease, there are minimally invasive alternatives to heart transplant for the dangerously weak heart (extreme heart failure) which can otherwise result in Cardiogenic Shock. These involve various means to augment or complement the pumping function of the heart, such as a Ventricular Assist Device (VAD) .
With respect to the performance of Mitral Valve Replacement, the current practice favors bioprosthetic valves over mechanical valve replacement for most patients, initially just used for elderly to avoid need for coumadin, but now used at younger ages due to improvements in longevity of the bioprosthetic valves, plus less damage to red cells.
7.1.2 Percutaneous Endocardial Ablation of Scar-Related Ventricular Tachycardia
7.2.4 Experimental Therapy (Left inter-atrial shunt implant device) for Heart Failure: Expert Opinion on a Preliminary Study on Heart Failure with preserved Ejection Fraction
7.3.1 Dilated Cardiomyopathy: Decisions on implantable cardioverter-defibrillators (ICDs) using left ventricular ejection fraction (LVEF) and Midwall Fibrosis: Decisions on Replacement using late gadolinium enhancement cardiovascular MR (LGE-CMR)
Chapter 11: Comparison of Coronary Artery Bypass Graft (CABG) and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty
11.1 Hybrid Cath Lab/OR Suite
The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC
In an uncommon reversal of opinion, the combined forces of the American Heart Association (AHA) and the American College of Cardiology (ACC) reviewed compelling data and reversed a prior assessment on the need for an on-site cardiovascular surgery support for sites offering interventional cardiac catheterization. The data show that sites offering the intervention without a surgeon achieve better results that sites that ship patients out for the interventions, and that the risk without on-site thoracic surgery backup is negligible.
AHA, ACC Change in requirement for surgical support: Class IIb -> Class IIa Level of Evidence A: Supports Nonemergent PCI without Surgical Backup (Change of class IIb, level of Evidence B).
Larry H Bernstein, MD, FCAP and Justin D Pearlman, MD, PhD, FACC
11.1.2 Coronary Reperfusion Therapies: CABG vs PCI – Mayo Clinic preprocedure Risk Score (MCRS) for Prediction of in-Hospital Mortality after CABG or PCI
Author and Curator: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN
11.1.6 Patients with Heart Failure & Left Ventricular Dysfunction: Life Expectancy Increased by coronary artery bypass graft (CABG) surgery: Medical Therapy alone and had Poor Outcomes
11.2.8 CABG: a Superior Revascularization Modality to PCI in Patients with poor LVF, Multivessel disease and Diabetes, Similar Risk of Stroke between 31 days and 5 years, post intervention
percutaneous Left Ventricular Assist Device (pLVAD) – An Israeli startup, Magenta Medical, behind the world’s smallest heart pump has raised $55 million
Curator: Aviva Lev-Ari, PhD, RN
Updated on 7/24/2024
Israeli heart pump co Magenta Medical raises $105m
The company has developed a miniature heart pump that can be inserted into the body through minimally invasive surgery.
Israeli miniature heart pump developer Magenta Medical has today announced the completion of a $105 million financing round led by Novo Holdings with new investors Viking Global Investors and RA Capital Management, and existing investors OrbiMed, New Enterprise Associates (NEA), JVC Investment Partners, and ALIVE – Israel HealthTech Fund, also participated in this round.
Magenta Medical Closes $55M Funding Round Led by OrbiMed
Funding will further Magenta’s clinical programs in support of FDA approval for world’s smallest heart pump
Kadima, Israel – May 03, 2023 –Magenta Medical, developer of the world’s smallest heart pump, announced today a $55M financing round led by global healthcare investment manager OrbiMed, with participation from existing investors New Enterprise Associates (NEA), Pitango VC, and ALIVE – Israel HealthTech Fund. The financing will be used, among other things, to advance the clinical programs of the company’s product in the United States towards its first FDA approval.
Temporary mechanical circulatory support (MCS) is one of the fastest growing markets in interventional cardiology, encompassing devices that aim to augment the output of a failing heart, in the setting of dangerously low blood pressure, while resting the heart and providing a bridge to recovery over a period of hours or days. Existing temporary MCS devices provide limited flow, require an invasive surgical procedure, or both.
Magenta’s percutaneous Left Ventricular Assist Device (pLVAD) is a powerful heart pump that is initially folded, inserted through the groin using a small puncture, and expanded for activation inside the left ventricle. The flow of the pump is adjusted based on the clinical circumstances of the patient, up to the entire cardiac output, allowing the heart to rest and the patient to recover. Once the Magenta technology is approved, physicians will be able to rely on a single device to treat the full range of MCS patients, thus eliminating the need to escalate therapy to a new device and subject the patient to unnecessary and invasive replacement procedures.
“Magenta is proud to add OrbiMed to its growing roster of leading MedTech investors as a highly reputable partner for innovative medical device companies,” said Dr. David Israeli, CEO of Magenta Medical. “I am confident that together we can build an organization well-equipped to bring to the market high-impact technology that can potentially address multiple unmet needs in the general cardiology patient population, as well as in many under-served patient groups.”
The potential advantages of Magenta’s high-flow, low-profile device were recognized by the US FDA, resulting in Breakthrough Device Designation for two indications: high-risk percutaneous coronary intervention (HR-PCI) and cardiogenic shock (CS).
Magenta successfully completed a HR-PCI first-in-human (FIH) study in Tbilisi, Georgia, the results of which were presented at the recent 2022 Transcatheter Cardiovascular Therapeutics (TCT) conference in Boston, MA, by Dr. Duane Pinto of Beth Israel Deaconess Medical Center and Harvard Medical School. Building on this experience, Magenta is now preparing to launch its clinical programs in the US, starting with an imminent HR-PCI Early Feasibility Study.
“Having supported Magenta’s FIH study, I was thoroughly impressed with the unique combination of a low-profile device delivering best-in-class flow,” said Dr. Pinto. “Magenta’s device is inserted with ease percutaneously and can accommodate the full gamut of flows required by MCS patients in the various situations I encounter as an interventional cardiologist. Use of this technology can be mastered by a wide range of proceduralists to better address the unmet needs of contemporary patients, such as those with small or challenging vascular anatomies, especially if high flows are needed.”
“We are excited to have identified the merits of Magenta’s technology, with its strong disruptive potential, and are extremely pleased with the relationships that we have built with management, the founders, and the existing investors,” said Dr. David Bonita, General Partner at OrbiMed. “We look forward to advancing the clinical programs and accelerating the introduction of this important technology to the market in the US and globally.”
Magenta’s proprietary technology miniaturizes a powerful percutaneous Left Ventricular Assist Device to fit an 8 Fr delivery system – the smallest crimping profile of any such device. The pump is inserted percutaneously, over a guidewire, through the aorta and across the aortic valve, using commercially available 10 Fr introducer sheaths. Employing standard catheterization techniques and equipment for placement has important advantages in terms of ease-of-use, safety, physician access, and vascular access closure. Once deployed inside the heart, the speed of the pump can be adjusted to provide more than 5 L/min of mean blood flow at physiological blood pressures – the full cardiac output of an adult – allowing the heart to rest and the patient to recover. With peak flows exceeding 7 L/min, this is the most powerful known percutaneous pump, comparing favorably even with surgically placed catheter pumps that have more than twice Magenta’s insertion profile.
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About Magenta Medical
Magenta Medical Ltd. is a privately-held company dedicated to the development of miniaturized blood pumps intended to provide minimally-invasive support to the native heart during acute episodes of dysfunction that could lead to dangerously low blood pressure and compromised perfusion of vital organs. Magenta’s Elevate™ percutaneous left ventricular assist device is currently in clinical testing, with the ultimate goal of securing approval for at least two indications: patients undergoing high-risk coronary interventions and patients with cardiogenic shock. Magenta Medical was founded by two serial entrepreneurs, Professor Ehud Schwammenthal and Mr. Yosi Tuval, who previously founded Ventor Technologies – a medical device company that was acquired by Medtronic in 2009. For more info, visit https://magentamed.com/.
About OrbiMed
OrbiMed is a healthcare investment firm, with approximately $17 billion in assets under management. OrbiMed invests globally across the healthcare industry through a range of private equity funds, public equity funds, and royalty/credit funds. OrbiMed’s team of over 100 professionals is based in New York City, San Francisco, Shanghai, Hong Kong, Mumbai, Herzliya and other key global markets.
Magenta has developed a miniaturized catheter-mounted axial flow-pump for mechanical circulatory support of the left ventricle.
Israeli company Magenta Medical has announced the completion of a $55 million financing round led by OrbiMed Advisors and with the participation of previous investors NEA, Pitango and Alive.Magenta has developed a miniaturized catheter-mounted axial flow-pump for mechanical circulatory support of the left ventricle, based on Magenta’s core technology of a self-expanding impeller and pump head. The self-expanding impeller is comprised of a thin memory-shape metallic frame and a soft, flexible material that forms the body of the blades.Magenta Medical was founded in 2012 by CMO Prof. Ehud Schwammenthal and CTO Dr. Yosi Tuva, who had previously founded heart valve developer Ventor, which was sold to Medtronic in 2009 for $350 million. Magenta’s CEO is Dr. David Israeli, a former senior executive at Medtronic and Pitango, which invested in the company. Magenta has raised $100 million to date.Dr. Israel told “Globes” that Magenta has changed its focus in recent years but not its technology – only the use it is aiming for. The pump was first developed to treat heart failure and was intended to be implanted in the renal veins to regulate blood pressure and evacuate salts and fluids – an improved replacement for diuretic drugs that are the standard treatment for heart failure, but they are not always helpful, and may have side effects. This product was already advanced, so with the company’s previous fundraising, it believed it could get the product approved without additional fundraising.The reason for the change was the realization that the road to approval was longer than it seemed at first, because there is no such product on the market, and it was necessary to develop the protocol from start to finish, together with the FDA, and then overcome another hurdle of proving the economic value of the product to obtain insurance indemnity. So even though the product worked well, and despite (or rather because) there being no similar solutions on the market, the road looked too long and uncertain.
Meanwhile, another area began to capture the company’s attention: using a coronary artery pump to support patients arriving at the hospital with acute heart failure or undergoing high-risk interventional catheterization. The pump supports the heart’s activity and can even replace it until it recovers.
The field called Temporary Mechanical Circulatory Support has been growing in recent years led by Johnson & Johnson unit Abiomed. Magenta believes that as other products have already trod the regulatory path and then received insurance indemnity, the way forward in this sector is clearer while there remains plenty of room in the market for their distinct product.
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NEA makes first Israeli investment in Magenta Medical
The product has undergone trials with 15 patients in Georgia and is now undergoing a trial with 15 more patients in the US.
Published by Globes, Israel business news – en.globes.co.il – on May 3, 2023.
An Israeli startup behind the world’s smallest heart pump has raised $55 million.
Magenta Medical’s device will be used to support patients arriving at the hospital with heart failure, or undergoing high-risk treatments to alleviate their symptoms.
The pump can support the heart’s activity, and even replace it for several days until it recovers, by temporarily opening clogged arteries in the hearts of cardiac patients, and improving symptoms like chest pain and shortness of breath.
The pump is folded up and inserted through a catheter via the groin. Once it has been guided to the heart’s left ventricle (which is responsible for pumping oxygenated blood all over the body), and the catheter has been removed, it expands by up to three and a half times.
Inside the heart, the speed of the pump can be adjusted to provide more than five liters of blood a minute – the full cardiac output of an adult at rest. The company says the pump is more powerful than others, with peak flows exceeding seven liters per minute.
Existing temporary devices provide a more limited flow of oxygenated blood to the body’s tissues or require an invasive surgical procedure – or both.
Magenta Medical’s product has undergone trials with 15 patients in Georgia, USA. The company is now preparing to launch its clinical programs in the US. The financing will be used to advance the clinical programs of the product towards its first FDA approval.
The funding was raised by global healthcare investment manager OrbiMed, with participation from existing investors New Enterprise Associates, Pitango VC, and ALIVE – Israel HealthTech Fund.
“Magenta is proud to add OrbiMed to its growing roster of leading MedTech investors as a highly reputable partner for innovative medical device companies,” said CEO Dr. David Israeli.
“I am confident that together we can build an organization well-equipped to bring to the market high-impact technology that can potentially address multiple unmet needs in the general cardiology patient population, as well as in many under-served patient groups.”
Magenta Medical was founded in 2012, and is based in Kadima Zoran, central Israel.
In Cardiology, “Interventional” is reserved for procedures that directly produce physical changes. Surgical interventions for cardiovascular diseases include heart or heart and lung transplant, implantation of cardiac assist devices, shock devices and pacemakers, bypass grafts for coronary or other arteries, valve repairs or replacement, removal of plaque (endarterectomy), removal of tumors, and repair or palliation of injuries or of congenital anomalies. All of these interventions are continually studied and improved, with a major effort at minimizing the risk, reducing recovery time and reducing the size of entry scar, for example by use of video scopes instead of direct visualization, and mechanical devices and robotics instead of direct manual access. Interventional Cardiology refers to an often competing non-surgical approach in which access is limited to entry by vein or artery (catheterization). The two teams have joined forces to achieve a major success in replacing aortic valves by femoral artery access without opening the chest at all (TAVR), with on-going progress towards a similar approach to mitral valve replacement.
This book addresses disease prevalence, personalized patient and doctor experiences with Cardiac Surgery, the role of transfusion, status of the MedTech market, and a review of major accomplishments from pathology, anesthesiology, radiology, cardiology and surgery. The contributions of specific groups, such as the Texas Heart Institute, the Dalio Institute at New York Presbyterian/Weill Cornell, the Cleveland Clinic, and the Scripps Institute are reviewed. Individual contributions from Eric Topol, Arthur Moss, Paul Zoll, Tim Wu, and Earl E. Bakken (Medtronic co-founder) are included. Discoveries in relevant biology, including ATP (the metabolic paycheck) and plasma metabolomics, and novel technologies such as tethered-liquid perfluorocabon surface biocoating to prevent clotting. Additional curations present views of cardiothoracic surgeons, vascular surgeons and of Catheterization lab interventionists. Business aspects are addressed by review of costs, prevalence, payment methods, prevention impact and business models. Decision support tools are also reviewed, and changes in guidelines. Voices of three Open Heart Surgery Survivors are included. Chapters 4-6 addressed clinical trial data in coronary disease, biomarkers of cardiovascular disorders, coagulation including top roles of nitric oxide, C-reative protein, protein C, aprotinin and thrombin. Chapters 7-8 covered amyloidosis, atherosclerosis, valve disease, flow reserve, atrial fibrillation and roles for advanced imaging. Chapters 9-10 covered unstable angina, transplants, and ventricular assist devices. Chapters 11-14 span interventions on the aorta, peripheral arteries, and coronary arteries, valve surgery and percutaneous valve repair or replacement, plus the growing role of prosthetics and repair by stem cells and tissue engineering.
As catheter techniques evolved to compete with bypass surgery they progressed from balloon cracking of obstructive lesions (POBA=plain old balloon angioplasty) to placement of stents (wire fences). Surgeons sometimes use in-stent valves, and now devices analogous to in-stent valves can be placed by catheter for valve replacement in patients with too much co-morbidity to go through heart surgery. Aortic valve replacement by stent (TAVR) has had sufficient success to be considered for all patients who have sufficient impairment to merit intervention. The diameter is large, so a vascular surgeon participates in the arterial access and repair of the access site.
Minimally invasive repair of abdominal aorta aneurysm: atherosclerosis offers potentially somewhat protective stiffening of the arterial wall, it can promote clots, athero-emboli, and failure of the remodeling can lead to an outward ballooning, or aneurysm, that promotes both clot formation and wall or lining tears or rupture, cause of sudden death.
Chapter 7: Ventricular Failure: Assist Devices, Surgical and Non-Surgical
7.1 Trends in the Industry
The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC
In addition to minimally invasive treatments for coronary disease and valve disease, there are minimally invasive alternatives to heart transplant for the dangerously weak heart (extreme heart failure) which can otherwise result in Cardiogenic Shock. These involve various means to augment or complement the pumping function of the heart, such as a Ventricular Assist Device (VAD) .
With respect to the performance of Mitral Valve Replacement, the current practice favors bioprosthetic valves over mechanical valve replacement for most patients, initially just used for elderly to avoid need for coumadin, but now used at younger ages due to improvements in longevity of the bioprosthetic valves, plus less damage to red cells.
7.1.1 Spectranetics, a Technology Leader in Medical Devices for Coronary Intervention, Peripheral Intervention, Lead Management to be acquired by Philips for 1.9 Billion Euros
7.2.4 Experimental Therapy (Left inter-atrial shunt implant device) for Heart Failure: Expert Opinion on a Preliminary Study on Heart Failure with preserved Ejection Fraction
7.3.1 Dilated Cardiomyopathy: Decisions on implantable cardioverter-defibrillators (ICDs) using left ventricular ejection fraction (LVEF) and Midwall Fibrosis: Decisions on Replacement using late gadolinium enhancement cardiovascular MR (LGE-CMR)
Amyloidosis inserts abnormal proteins into tissues – in the heart, that results in an insidious decline cardiac function marked by increased stiffness (requiring high filling pressures that wet the lungs) and decreased contractility or inotropy (pumping ability). resulting in poor circulation of nutrients to tissues and organs. Amyoloidosis is suspected when imaging shows thickened heart muscle and thickened valves with reduced function, but thickened muscle also occurs as a reaction to incomplete control of elevated blood pressures, as well as by other infiltrative disorders.
Hoping to learn more about how robotic mitral repair compares with surgery, Benharash et al. examined data from more than 40,000 patients who underwent treatment from 2016 to 2020. Nearly 10% of those patients underwent robotic mitral repair. The median ages for the two groups were nearly identical—approximately 61 years old—but robotic mitral repair patients were more likely to be men, have private insurance coverage and belong to the highest income quartile. These patients were also less likely to present with certain comorbidities, including chronic lung disease, end-stage renal disease, peripheral vascular disease and pulmonary hypertension.
Overall, robotic mitral repair and surgery resulted in comparable rates of in-hospital mortality, stroke, blood transfusion, reoperation and hospital readmission. In addition, robotic treatment was associated with lower rates of pulmonary complications (6.1% vs. 8.1%), postoperative infection (1.7% vs. 3.4%) and acute kidney injury (AKI) (5.7% vs. 8.5%) as well as significantly shorter lengths of stay and a reduced chance of being discharged to another type of healthcare facility.
As one may expect, however, mean healthcare costs were considerably higher for robotic mitral repair ($53,600 vs. $45,200).
A team of specialists with Cedars-Sinai in Los Angeles, including veteran cardiac surgeon Alfredo Trento, MD, shared their perspective about this research in a separate editorial.[2] The group congratulated the authors for their work, highlighting the importance of learning more about this topic, but they also wrote shared some concerns about the study’s findings. The fact that robotic treatment was more commonly used to treat patients who earn a higher income, for example, suggests that the increased costs of robotic mitral repair could not necessarily be as beneficial for all patients.
“A health intervention that can only be performed at a handful of hospitals by a select group of individuals is not necessarily a good intervention as it is not generalizable and not applicable to most of the population,” the group wrote. “For cardiac surgery to remain relevant in the mitral realm, we must be able to offer safe, durable repairs in a noninvasive manner to as much of the population as possible.”
Mitral valve surgery is performed when the heart’s mitral valve needs to be repaired. Traditionally, mitral valve surgery required opening the chest and putting the patient on heart-lung bypass to keep blood circulating during surgery. Since 2016, UCSF surgeons have been performing minimally invasive mitral valve surgery without having to open the sternum and with smaller incisions. Robotically assisted mitral valve surgery adds yet another level of precision.
“Robotically assisted mitral valve surgery allows us to make even smaller incisions with greater precision,” said Tom C. Nguyen, M.D., robotic heart surgeon and chief of Cardiothoracic Surgery at UCSF. “By using the robotic arms, we have more degrees of articulation than with our natural wrists. The robot also magnifies the surgical field 10X in 3D. Ultimately, this translates into more precise surgery with faster recovery.”
During the robotically assisted surgery, the surgeon looks through a 3D camera to see the mitral valve as well as other structures inside the heart. The surgeon uses the robotic surgical system to guide the robotic arms and movements of the surgical instruments.
“Every valve looks different, and the extraordinary 3D vision that the robot camera provides, is just a real step up from all the technologies we have been using in the past,” said Tobias Deuse, M.D., cardiac and transplant surgeon and director of Minimally-invasive Cardiac Surgery. “The camera, together with the increased mobility of the instruments, allows for a very thorough evaluation of the valve and helps us make good and long-lasting repairs.”
Thanks to these innovations, mitral valve patients have fewer complications and can be discharged within three-to-four days. This patient’s symptoms included increased fatigue and palpitations. Since the surgery, he is at home and his recovery is going well.
In addition to mitral valve surgery, there are plans for additional robotically assisted cardiothoracic surgeries, including removal of intracardiac tumors and myxomas as well as for coronary revascularization.
Other robotic surgeries currently being performed at UCSF
encompass a wide range of specialties and procedures, including:
removing cancerous tissue from the lungs, uterus, ovaries, colon, rectum, esophagus, bladder, prostate, head and neck, liver and pancreas. Other robotic surgeries are used for
the treatment of uterine fibroids and endometriosis, female pelvic organ prolapse repairs,
hernia repairs and
bariatric surgery.
Other related articles on Mitral Valve Repair published in this Open Access Online Scientific Journal include the following:
Aortic Valve Transplant Via Carotid Artery at Hadassah – An Israel First
Curator and Reporter: Aviva Lev-Ari, PhD, RN
The transplant using the carotid artery as the point of entry was selected. The technique of trans-carotid access, Dr. Planer, Director of Hadassah’s Catheterization Department says, “is not performed in “the majority of medical centers worldwide.”
The Medical Case
A 76-year-old man with a history of critical stenosis of his aortic valve arrived at Hadassah Hospital Ein Kerem in severe cardiac shock. It was clear he needed a valve transplant urgently, but the traditional surgical options were not suitable for him because he also had severe vascular disease, anatomical limitations and had undergone previous heart bypass surgery.
Dr. Planer explains, “Until two decades ago, patients who required an aortic valve replacement had to have surgery that involved opening the chest. The recovery was long and difficult.”
This procedure, says Dr. Planer, “is performed using a hybrid approach, with catheterization specialists and cardiac surgeons.” Using this collaborative approach, Dr. Planer, Dr. Gabby Elbaz-Greener, senior catheterization specialist and head of the Structural Heart Intervention Program; Dr. Amit Korach, senior cardiac surgeon; Prof. Ronen Beeri, director of the Echocardiography Unit and senior anesthesiologist; and Dr. Tamer Abu Jreis, anesthesiology resident, successfully replaced the valve.
“Beyond choosing the right patient and the high technical capacity of the team, in a procedure such as this, it is of utmost importance for us to work harmoniously, despite coming from different disciplines,” says Dr. Planer. “Thankfully, the operation went smoothly and without complications. We are proud to be the first team in Israel to carry it out and pave the way for an additional therapeutic option for these seriously ill patients. Our patient has now been discharged to begin rehabilitation, and we wish him a full recovery.”
The optimal access for patients undergoing transcatheter aortic valve replacement (TAVR) who are not candidates for a transfemoral approach has not been elucidated. The purpose of this study was to compare the safety, feasibility, and early clinical outcomes of transcarotid TAVR compared with thoracic approaches.
Methods and Results
From a multicenter consecutive cohort of 329 alternative-access TAVR patients (2012–2017), we identified 101 patients who underwent transcarotid TAVR and 228 patients who underwent a transapical or transaortic TAVR. Preprocedural success and 30-day clinical outcomes were compared using multivariable propensity score analysis to account for between-group differences in baseline characteristics. All transcarotid cases were performed under general anesthesia, mainly using the left common carotid artery (97%). Propensity-matched groups had similar rates of 30-day all-cause mortality (2.1% versus 4.6%; P=0.37), stroke (2.1% versus 3.5%; P=0.67; transcarotid versus transapical/transaortic, respectively), new pacemaker implantation, and major vascular complications. Transcarotid TAVR was associated with significantly less new-onset atrial fibrillation (3.2% versus 19.0%; P=0.002), major or life-threatening bleeding (4.3% versus 19.9%; P=0.002), acute kidney injury (none versus 12.1%; P=0.002), and shorter median length of hospital stay (6 versus 8 days; P<0.001).
Conclusions
Transcarotid vascular access for TAVR is safe and feasible and is associated with encouraging short-term clinical outcomes. Our data suggest a clinical benefit of transcarotid TAVR with respect to atrial fibrillation, major bleeding, acute kidney injury, and length of stay compared with the more invasive transapical or transaortic strategies. Randomized studies are required to ascertain whether transcarotid TAVR yields equivalent results to other alternative vascular access routes.
This is the first report of a multicenter propensity score-matched comparison between transcarotid and transthoracic access. The main findings are (1) transcarotid TAVR is safe and feasible in appropriately selected patients with a high rate of device success (87%); (2) compared with transapical and transaortic TAVR, the transcarotid approach was associated with no significant difference in rates of 30-day all-cause mortality, stroke, new pacemaker implantation, major vascular complications, and hemodynamic performance; (3) transcarotid TAVR is associated with significantly less new-onset atrial fibrillation, acute kidney injury, major or life-threatening bleeding, and shorter hospital stay.
TAVR technology has evolved considerably in the last few years allowing for the treatment of 85% to 90% of patients via the transfemoral route.4,15,16 Until recently, the transapical and transaortic approaches were considered the main alternative nontransfemoral routes, with comparable short- and long-term outcomes.17–19 Despite their advantage of simplifying valve positioning, major surgical manipulation of the chest wall is required. Furthermore, these techniques are limited by relative contraindications, such as significant respiratory failure in case of transapical, and porcelain aorta, as well as previous heart surgery, in cases of transaortic. Transcarotid TAVR was first performed in France in 2009,20 and then was subsequently adopted by several other centers.7–9,21,22 These experiences demonstrated that the surgical approach to the carotid artery is safe and relatively uncomplicated because of its superficial location, and operative experience with the carotid arteries is widespread among cardiovascular surgeons. We prefer performing transcarotid TAVR using the left common carotid because it allows superior coaxial alignment of the THV with the aortic annulus, although both sides can be used.9,10,21
In the current study, the 30-day crude stroke or TIA rate in the transcarotid group was 3% (2 disabling and 1 nondisabling stroke), with no significant difference compared with the transapical/transaortic group (as previously described in smaller studies).10,11 This stroke rate is lower than that observed in the cohort of patients included in the multicenter French Transcarotid TAVR Registry and others.8,9 As previously described,8,21 these neurological events are not always localized ipsilateral to the CCA used for TAVR. This suggests that there are other phenomena at play in addition to carotid arterial manipulation, such as new-onset postprocedural atrial fibrillation, periprocedural hypotension, inadequate contralateral carotid perfusion, and the THV deployment itself. Although the rates of preimplant and postimplant balloon valvuloplasty were significantly higher in the transapical/transaortic group even after adjustment, this did not translate to a higher risk of stroke or TIA among the transapical/transaortic patients. The low rate of stroke observed in this study may be attributed to careful patient selection and the intraoperative assessment of the functional integrity of the circle of Willis as used in one center in this study, using indirect methods, such as backflow blood pressure during carotid clamping and cerebral oximetry monitoring.7 However, the optimal preprocedural evaluation and periprocedural neurological monitoring during transcarotid TAVR are yet to be determined. Also, the optimal antithrombotic regimen and the role of embolic protection devices23–25 require further study to determine efficacy in the reduction of the risk of cerebral ischemia, specifically in patients undergoing transcarotid TAVR as literature is scarce in these patients.
Other major findings of this study were that transcarotid TAVR was significantly associated with a reduction in major or life-threatening bleeding and shorter LOS, compared with transapical/transaortic TAVR. This could be explained by (1) less-invasive access site exposure in the case of transcarotid TAVR compared with a minithoracotomy or hemisternotomy in the transapical/transaortic approach; (2) less ventilator use and shorter intensive care unit stay in transcarotid TAVR10; and (3) less pain during the postprocedural recovery and earlier patient mobilization. The lower incidence of new-onset atrial fibrillation among transcarotid TAVR patients may also partly explain shorter LOS. Any incision of the thoracic cavity is associated with various forms of supraventricular arrhythmia, most commonly atrial fibrillation, which may then translate to a prolonged hospital stay.26,27 A reduction of LOS is a critical component of current strategies to control overall costs associated with TAVR and may be the primary driver of reduced expenditure associated with transfemoral TAVR compared with alternative-access TAVR.28–30 Furthermore, severe bleeding may be associated with postprocedural hypovolemia and may explain, in part, the reduction in the rates of severe acute kidney injury in transcarotid cases compared with the transapical/transaortic approach.31,32 Similar findings were previously reported when comparing transapical or transaortic with transfemoral access. Blackstone et al33 reported their results in 501 propensity score-matched patients undergoing transapical versus transfemoral TAVR. More patients in the transapical group experienced adverse procedural events, longer length of stay, slower recovery, and higher transfusion rates. Similar results were published by Arai et al,34 who reported significantly higher rates of life-threatening bleeding when comparing transaortic (n=289) with transfemoral TAVR (n=467; 6% versus 3%, respectively; P=0.021) without a significant difference in other major outcomes. Our data also suggest that the risk of major vascular complications are decreased with a transcarotid TAVR approach (matched analysis, 3.2% versus 10.7%; P=0.05), although the study was underpowered for this specific end point and did not reach statistical significance.
Postoperative echocardiographic data showed favorable results in both groups, as either access provides direct aortic annular access and may allow superior positioning in particular anatomies (Figure). The observed 30-day mortality in the adjusted analysis (2.1% versus 4.6%; P=0.37; transcarotid versus transapical/transaortic, respectively) was also statistically comparable between groups and lower than that previously reported in transcarotid TAVR cohorts.8,9
Study Limitations
This report consists of a retrospective analysis of prospectively acquired data and is subject to the limitations inherent in this study design. Selection of patients was not random and may not be generalizable to other centers. Other alternative approaches, such as the subclavian route, were not evaluated because of the limited number of patients undergoing TAVR by subclavian access at the participating centers. The superficial position of the carotid artery coupled with the more complex exposure of the subclavian and its proximity to the brachial plexus, and the risks associated with its use if an ipsilateral internal mammary artery was used as a coronary bypass graft, have lead us to favor transcarotid over the subclavian approach. As well, specific end points, such as mortality, stroke, and major vascular complications, may have not reached statistical significance because of the small sample size and short-term follow-up. However, this is the largest multicenter study evaluating the transcarotid approach using a risk-adjusted comparator arm. Small numbers did not permit us to ascertain device-specific outcomes. However, adjusting the analysis for type of THV, we found that the association between decreased major bleeding and the transcarotid approach was modulated, in part, by the use of newer valve types with their lower profile delivery systems but was not entirely explained by this feature of the newer THVs (Appendix in the Data Supplement). Taken further, this association may also be access site specific and not entirely device specific. Accessing proximal high-pressure structures, such the left ventricular apex and ascending aorta, may be associated with less ability to adequately control bleeding compared with distal arterial sites, such as the carotid artery. Device-specific features of the newer TAVR prostheses, such as improved sealing skirts, did not influence postprocedural aortic regurgitation, need for a permanent pacemaker, pressure gradients, and overall procedural success rates in our study, which were similar between the transcarotid and transapical/transaortic groups.
Periprocedural cerebral monitoring was variable among institutions during transcarotid TAVR, reflecting a lack of consensus in the literature, and the rates of neurological events may have been underestimated because systematic evaluation by magnetic resonance imaging was not routinely performed following TAVR. However, the incidence of stroke/TIA was low and did not differ among centers (Table VII in the Data Supplement); the optimal perioperative neuromonitoring technique remains to be prospectively elucidated. However, all clinically significant neurological changes were identified, and all sites had a low-threshold trigger for consultation by a neurologist and the performance of neuroimaging post-TAVR. Preprocedural and postprocedural antiplatelet and anticoagulation therapy were not consistently captured across the study centers, which may confound the association between the approaches studied and outcomes, such as bleeding, cerebrovascular events, and mortality. However, all centers stopped the second antiplatelet agent at least 48 hours before the procedure for patients undergoing transapical or transaortic TAVR. We, therefore, cannot attribute the increased bleeding rates associated with transapical/transaortic solely to preoperative double antiplatelet therapy.
Conclusions
Transcarotid vascular access for TAVR is safe, feasible, and associated with encouraging short-term clinical outcomes in terms of mortality, stroke, and major vascular complications in patients who are not candidates to transfemoral TAVR. Furthermore, the transcarotid approach was associated with lower rates of major or life-threatening bleeding, new-onset atrial fibrillation, acute kidney injury, and shorter LOS compared with transapical or transaortic access. Larger prospective studies with longer follow-up are needed to confirm the safety and clinical efficacy of transcarotid TAVR compared with alternative approaches.
Figure.Comparative 30-day/in-hospital outcomes of different access routes for transcatheter aortic valve replacement ( TAVR) according to the VARC definitions.
Volume Six: Interventional Cardiology for Disease Diagnosis and Cardiac Surgery for Condition Treatment. On com since 12/24/2018 https://lnkd.in/e_CTb4R
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