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Article SELECTION from Collection of Aviva Lev-Ari, PhD, RN Scientific Articles on PULSE on LinkedIn.com for Training Small Language Models (SLMs) in Domain-aware Content of Medical, Pharmaceutical, Life Sciences and Healthcare by 15 Subjects Matter
Article selection: Aviva Lev-Ari, PhD, RN
#1 – February 20, 2016
Contributions to Personalized and Precision Medicine & Genomic Research
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
“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.”
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
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
JenaValve, a California-based transcatheter aortic valve replacement (TAVR) company, has found considerable success in Europe with its Trilogy Heart Valve System for high-risk patients with symptomatic, severe aortic regurgitation (AR), gaining CE mark approval for the device in May 2021. The company has been working toward gaining U.S. Food and Drug Administration (FDA) approval for Trilogy, and recent data have suggested that moment could come sooner than later.
JenaValve shared its excitement about the acquisition on social media, saying its employees remain focused on developing “the world’s first transcatheter heart valve technology uniquely designed for patients with AR.”
“Together with Edwards, the world’s leader in TAVR, we are now closer to addressing the global unmet need,” the company wrote.
An 82-year-old man presenting with severe symptomatic tricuspid regurgitation (TR) and right heart failure (RHF).
Expert Opinion: The Voice of Dr. Justin D. Pearlman, MD, PhD, FACC
The TricValve addresses the problem of severe ìncompetance of the tricuspid valve with a relatively simple procedure.
Instead of the challenge of replacing the defective valve, a catheter procedùre places valves at the two venous intake locations, the superior and ìnferior vena cava. A valve at the superior vena cava entrance to the right atrium occurs occasionally in nature, but is usually absent or fenestrated, covering the medial end if the crista supraventricularis.
A similar termed valve is occasionally found in nature on the inferior vena cava. These supernumerary valves can arrest back flow of pressure and volume from the right atrium to the upper and lower venous systems, and alleviate in particular congestion of the liver.
Normally the right atrial pressure is low, in which case this would offer no significant advantage for reproductive success natural selection to offset potential interference with blood flow into the right atrium that might promote thrombosis [Folia Morphology Morphology 66(4):303-6, MRuso].
However, in a setting of right heart failure, such as occurs from pulmonary hypertension, the tricuspid valve often becomes incompetent, and placement of the pair of vena cava valves can alleviate upstream consequences, albeit at the cost of risk of thrombosis and future impediment to other future procedures such as ablation of supraventricular arrhythmia.
The vena cava valves placed by catheter at the Cleveland Clinic helped an 80 year old man alleviate his pressing issue of hepatic congestion. Unlike a replacement tricuspid valve this procedure does not alleviate high pressures dilatìng the right atrium. Instead, it can worsen that problem.
The CLASP II TR trial is investigating the Edwards PASCAL transcatheter repair system [CLASP II TR, Edwards Lifesciences Corp, NIH NCT 0497145]
Survival data for surgìcal tricuspid valve replacements reported 37+-10 percent ten year survival, with average all cause survival of just 8.5 years [Z HIscan, Euro J CT Surgery 32(2) Aug 2007]. None-the‐less, comparison of patients with vs without intervention for incompetance of the trìcuspid valve favored mechanical intervention [G Dreyfus Ann Thorac Surg 49:706-11,1990, D Adams, JACC 65:1931-8, 2015]. Time will tell which interventìon will prevail, and when these catheter alternatives to open chest surgery should be deployed.
Rishi Puri, MD, PhD, an interventional cardiologist with Cleveland Clinic, and Samir Kapadia, MD, chair of cardiovascular medicine at Cleveland Clinic, performed the procedure. Puri has years of experience with the TricValve system, participating in a thorough analysis of its safety and effectiveness in 2021.
The TricValve system features two biological valves designed to be implanted via femoral vein access into the patient’s superior vena cava and inferior vena cava. This allows a therapy without impacting the patient’s native tricuspid valve. It is available in multiple sizes, allowing cardiologists to choose the best option for each individual patient.
Cleveland Clinic’s statement detailing the successful procedure notes that patients with severe TR and RHF have typically had limited treatment options. Tricuspid valve surgery is associated with significant risks, for instance, and prescribing diuretics is problematic when the patient also presents with kidney problems.
“TricValve can potentially provide an effective and low-risk solution for many patients who currently have no treatment options,” Puri said, adding that the workflow is quite similar to transcatheter aortic valve replacement.
The TricValve Transcatheter Bicaval Valves System was developed by P+F Products + Features GmbH, a healthcare technology company based out of Vienna, Austria. The solution was granted the FDA’s Breakthrough Device designation in December 2020, but it has still not gained full FDA approval.
This procedure was completed under a compassionate-use clearance from the FDA.
In our chat, he summarized the key advances in transcatheter aortic valve replacements (TAVR) therapy and explained a key TAVR trend that came out of TVT for “lifetime patient management.”
It was clear at the meeting that the standard-of-care thinking on TAVR replacements has shifted from just getting a valve implanted and managing immediate complications to looking decades down the road and considering next steps with that same patient. TAVR now makes up about 70% or more of the procedure volume for aortic valve replacements. Latib said the focus of many sessions at TVT was on the longer-term management of valve patients since it is clear TAVR is becoming the standard of care. If a patient gets surgical or TAVR valve today, they will likely need a replacement in 10-20 years. More times than not, Latib explained, this replacement will come in the form of another TAVR valve deployed inside the first valve.
Latib said several sessions discussed what strategy is best, with many experts favoring surgical valve replacement first and two TAVR procedures later in life to eliminate the need for open heart surgery when the patient is much older and more frail. However, many experts admitted this might not be the strategy that gets adopted as a practical standard of care because most patients want the less invasive option versus surgery.
“I think all the companies have realized that they need to move their technologies in that direction,” Latib explained. “The bar has been set really high and so we are going to see a lot of new technologies or iterations of technology.”
The Edwards Lifesciences Sapien X4, the forth generation of the Sapien valve, is about to start the ALLIANCE pivotal trial. It is designed specifically for lower-risk patients with a lower frame height for better coronary access and it is the first balloon-expandable valve that allows the operator to turn the valve to align the commissures, which also will aid further coronary access. The valve is also designed to reduce the need to use oversized valves to ensure a good fit in the anatomy
“What this means is when you do the next valve you are not going to have issues with coronary access and having a more physiologically aligned valve on the commissures made help the valve last longer,” Latib said.
He said the Abbott Portico and Boston Scientific Acurate Neo2 TAVR systems are also undergoing revisions to make them more user friendly and compatible with the shifting needs of TAVR.
Tiberio Frisoli, M.D., interventional structural cardiologist, senior staff physician, Henry Ford Hospital, explains how his center performs transcaval transcatheter aortic valve replacement (TAVR) access for patients who have suboptimal abdominal aortic and femoral vascular anatomy. Transcaval access was pioneered at Henry Ford Hospital and involves using femoral vein access and then using a surgical radio frequency cutter to bore a hole from the interior venacava into the aorta to allow the TAVR delivery catheter to path through.
This procedure was developed to enable more patients to receive TAVR via the preferred femoral access route. Some patients are not candidates for femoral artery access because of calcified lesions and heart atherosclerotic plaque, which narrows the vessel lumen, and makes it difficult to thread catheters through. The transcaval access technique can bypass the restricted arteries or heavy calcified plaques to still enable a minimally invasive procedure without the need for surgery.
“Basically we’re considering blood as another vital organ,” he said. “Why that is important is because now we look at a patient’s blood system as an organ that needs to be assessed and treated for the sake of that organ and not simply to decide when or when not to transfuse.”
Recommendations span the entire spectrum from preoperative assessment of bleeding risk and anemia to intraoperative perfusion and blood salvage practices to postoperative treatment with human albumin for volume replacement.
“Most hospitals around the U.S. are acutely aware of patient blood management and, to some degree or another, are implementing many of the things we are talking about,” noted Tibi, who is immediate past president of SABM. Nationwide, the amount of blood transfused in cardiac surgery has dropped 45% in the past 10 to 15 years but still ranges widely from center to center.
Application of Natural Language Processing (NLP) on ~1MM cases of semi-structured echocardiogram reports: Identification of aortic stenosis (AS) cases – Accuracy comparison to administrative diagnosis codes (IDC 9/10 codes)
Reporter and Curator: Aviva Lev-Ari, PhD, RN
Large-Scale Identification of Aortic Stenosis and its Severity Using Natural Language Processing on Electronic Health Records
Background Systematic case identification is critical to improving population health, but widely used diagnosis code-based approaches for conditions like valvular heart disease are inaccurate and lack specificity. Objective To develop and validate natural language processing (NLP) algorithms to identify aortic stenosis (AS) cases and associated parameters from semi-structured echocardiogram reports and compare its accuracy to administrative diagnosis codes. Methods Using 1,003 physician-adjudicated echocardiogram reports from Kaiser Permanente Northern California, a large, integrated healthcare system (>4.5 million members), NLP algorithms were developed and validated to achieve positive and negative predictive values >95% for identifying AS and associated echocardiographic parameters. Final NLP algorithms were applied to all adult echocardiography reports performed between 2008-2018, and compared to ICD-9/10 diagnosis code-based definitions for AS found from 14 days before to six months after the procedure date. Results A total of 927,884 eligible echocardiograms were identified during the study period among 519,967 patients. Application of the final NLP algorithm classified 104,090 (11.2%) echocardiograms with any AS (mean age 75.2 years, 52% women), with only 67,297 (64.6%) having a diagnosis code for AS between 14 days before and up to six months after the associated echocardiogram. Among those without associated diagnosis codes, 19% of patients had hemodynamically significant AS (i.e., greater than mild disease). Conclusion A validated NLP algorithm applied to a systemwide echocardiography database was substantially more accurate than diagnosis codes for identifying AS. Leveraging machine learning-based approaches on unstructured EHR data can facilitate more effective individual and population management than using administrative data alone.
Large-scale identification of aortic stenosis and its severity using natural language processing on electronic health records
Systematic case identification is critical to improving population health, but widely used diagnosis code–based approaches for conditions like valvular heart disease are inaccurate and lack specificity.
Objective
To develop and validate natural language processing (NLP) algorithms to identify aortic stenosis (AS) cases and associated parameters from semi-structured echocardiogram reports and compare their accuracy to administrative diagnosis codes.
Methods
Using 1003 physician-adjudicated echocardiogram reports from Kaiser Permanente Northern California, a large, integrated healthcare system (>4.5 million members), NLP algorithms were developed and validated to achieve positive and negative predictive values > 95% for identifying AS and associated echocardiographic parameters. Final NLP algorithms were applied to all adult echocardiography reports performed between 2008 and 2018 and compared to ICD-9/10 diagnosis code–based definitions for AS found from 14 days before to 6 months after the procedure date.
Results
A total of 927,884 eligible echocardiograms were identified during the study period among 519,967 patients. Application of the final NLP algorithm classified 104,090 (11.2%) echocardiograms with any AS (mean age 75.2 years, 52% women), with only 67,297 (64.6%) having a diagnosis code for AS between 14 days before and up to 6 months after the associated echocardiogram. Among those without associated diagnosis codes, 19% of patients had hemodynamically significant AS (ie, greater than mild disease).
Conclusion
A validated NLP algorithm applied to a systemwide echocardiography database was substantially more accurate than diagnosis codes for identifying AS. Leveraging machine learning–based approaches on unstructured electronic health record data can facilitate more effective individual and population management than using administrative data alone.
Keywords
Aortic stenosis Echocardiography Machine learning Population health Quality and outcomes Valvular heart disease
2012pharmaceutical
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