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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
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.
Mangieri A, Lanzillo G, Bertoldi L, Jabbour RJ, Regazzoli D, Ancona MB, Tanaka A, Mitomo S, Garducci S, Montalto C, Pagnesi M, Giannini F, Giglio M, Montorfano M, Chieffo A, Rodès-Cabau J, Monaco F, Paglino G, Della Bella P, Colombo A, Latib A.
JACC Cardiovasc Interv. 2018 Aug 13;11(15):1519-1526. doi: 10.1016/j.jcin.2018.06.014.
Rodés-Cabau J, Urena M, Nombela-Franco L, Amat-Santos I, Kleiman N, Munoz-Garcia A, Atienza F, Serra V, Deyell MW, Veiga-Fernandez G, Masson JB, Canadas-Godoy V, Himbert D, Castrodeza J, Elizaga J, Francisco Pascual J, Webb JG, de la Torre JM, Asmarats L, Pelletier-Beaumont E, Philippon F.
Kim WK, Hengstenberg C, Hilker M, Kerber S, Schäfer U, Rudolph T, Linke A, Franz N, Kuntze T, Nef H, Kappert U, Zembala MO, Toggweiler S, Walther T, Möllmann H.
Wernly B, Zappe AK, Unbehaun A, Sinning JM, Jung C, Kim WK, Fichtlscherer S, Lichtenauer M, Hoppe UC, Alushi B, Beckhoff F, Wewetzer C, Franz M, Kretzschmar D, Navarese E, Landmesser U, Falk V, Lauten A.
Clin Res Cardiol. 2018 Jul 12. doi: 10.1007/s00392-018-1326-z. [Epub ahead of print]
Musa TA, Treibel TA, Vassiliou VS, Captur G, Singh A, Chin C, Dobson LE, Pica S, Loudon M, Malley T, Rigolli M, Foley JRJ, Bijsterveld P, Law GR, Dweck MR, Myerson SG, McCann GP, Prasad SK, Moon JC, Greenwood JP.
Damluji AA, Murman M, Byun S, Moscucci M, Resar JR, Hasan RK, Alfonso CE, Carrillo RG, Williams DB, Kwon CC, Cho PW, Dijos M, Peltan J, Heldman AW, Cohen MG, Leroux L.
Tang GHL, Zaid S, George I, Khalique OK, Abramowitz Y, Maeno Y, Makkar RR, Jilaihawi H, Kamioka N, Thourani VH, Babaliaros V, Webb JG, Htun NM, Attinger-Toller A, Ahmad H, Kaple R, Sharma K, Kozina JA, Kaneko T, Shah P, Hirji SA, Desai ND, Anwaruddin S, Jagasia D, Herrmann HC, Basra SS, Szerlip MA, Mack MJ, Mathur M, Tan CW, Don CW, Sharma R, Gafoor S, Zhang M, Kapadia SR, Mick SL, Krishnaswamy A, Amoroso N, Salemi A, Wong SC, Kini AS, Rodés-Cabau J, Leon MB, Kodali SK.
Steinvil A, Buchanan KD, Kiramijyan S, Bond E, Rogers T, Koifman E, Shults C, Xu L, Torguson R, Okubagzi PG, Pichard AD, Satler LF, Ben-Dor I, Waksman R.
Am Heart J. 2018 Jun;200:11-16. doi: 10.1016/j.ahj.2018.01.007. Epub 2018 Jan 31.
Liebetrau C, Gaede L, Kim WK, Arsalan M, Blumenstein JM, Fischer-Rasokat U, Wolter JS, Kriechbaum S, Huber MT, van Linden A, Berkowitsch A, Dörr O, Nef H, Hamm CW, Walther T, Möllmann H.
Int J Cardiol. 2018 Aug 15;265:40-46. doi: 10.1016/j.ijcard.2018.02.037.
Aortic Stenosis (AS): Managed Surgically by Transcatheter Aortic Valve Replacement (TAVR) – Search Results for “TAVR” on NIH.GOV website, Top 16 pages
Reporter: Aviva Lev-Ari, PhD, RN
UPDATED on 9/24/2018
Sapien 3, CoreValve Evolut R on Par for Aortic Stenosis
Head-to-head trial also shows local, general anesthesia outcomes similar
by Ashley Lyles, Staff Writer, MedPage Today
This article is a collaboration between MedPage Today® and:
SAN DIEGO — Transfemoral transcatheter aortic valve replacement (TAVR) with the balloon-expandable Edwards Sapien 3 valve yields the same early outcomes as the self-expanding CoreValve Evolut R, regardless of anesthesia strategy, a two-by-two randomized trial showed.
In the valve comparison, the primary endpoint of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days met criteria for equivalence, with a composite rate of 27.2% with Evolut R and 26.1% with Sapien 3, Holger Thiele, MD, of University Hospital in Leipzig, Germany, reported here at the Transcatheter Cardiovascular Therapeutics meeting.
The researchers also evaluated the effects of anesthesia used during these procedures and found no significant difference. The composite endpoint at 30 days came out 27.0% for local anesthesia and 25.5% for general anesthesia.
“The SOLVE-TAVI trial is the first adequately powered randomized trial comparing local versus general anesthesia in patients with symptomatic aortic valve stenosis undergoing TAVR,” said Thiele in a press release. “Results indicate that local anesthesia is both safe and effective and may be a good option for those patients undergoing TAVR with an intermediate or high surgical risk.”
In the majority of aortic stenosis cases, it doesn’t matter which valve you choose, although there are still some cases, like heavy calcification, when it may be better to choose one valve over the other, noted panel discussant Molly Szerlip, MD, of Baylor Scott & White The Heart Group in McKinney, Texas.
The researchers evaluated 447 patients who were receiving care at German medical centers for severe symptomatic aortic stenosis and were at an intermediate- to high-surgical risk. The patients were randomized to have the Sapien 3 valve or CoreValve Evolut R and to either receive general or local anesthesia with conscious sedation.
The individual valve strategy findings again showed equivalence without superiority between Evolut R and Sapien 3 for mortality (2.8% vs 2.3%) and moderate or severe valve regurgitation (1.9% vs 1.4%). But for stroke Evolut R came out superior (0.5% vs 4.7%), and the two didn’t meet criteria for equivalence on pacemaker implantation (22.9% vs 19.0%, P=0.06 for equivalence).
“The rate of relevant valve regurgitation was low whereas permanent pacemaker rates are still relatively high,” the researchers wrote.
The anesthesia comparison endpoints all met the criteria for equivalence without superiority of general anesthesia over local anesthesia:
The concept of transcatheter balloon expandable valves was first introduced in the 1980s by a Danish researcher by the name of H. R. Anderson who began testing this idea on pigs. In 2002, Dr. Alain Cribier performed the first successful percutaneous aortic valve replacement on an inoperable patient. The first approval of TAVR for the indication of severe AS in prohibitive risk patients came in 2011. In 2012, the FDA approved TAVR in patients at high surgical risk. In 2015 the indication was expanded to include “valve-in-valve” procedure for failed surgical bioprosthetic valves. Most recently, in 2016 the FDA approved the SAPIEN valve for use in patients with severe AS at intermediate risk.
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ICER announced plans to look at icosapent ethyl (Vascepa) and rivaroxaban (Xarelto) as add-on therapies in cardiovascular disease.
Heart attack risk is rising among young women. But NHANES data show women are still ahead of men on control of hypertension, diabetes, and cholesterol. (Circulation)
Two Classes of Antithrombotic Drugs: Anticoagulants and Antiplatelet drugs
Reporter: Aviva Lev-Ari, PhD, RN
These drugs are used to treat
strokes,
myocardial infarctions,
pulmonary embolisms,
disseminated intravascular coagulation (DIC) and
deep vein thrombosis (DVT)
— all potentially life-threatening conditions.
THERAPEUTIC STRATEGIES
• Degrade fibrinogen/fibrin (fibrinolytic agents)
GOAL: eliminate formed clots
• Inhibit clotting mechanism (anticoagulants)
GOAL: prevent progression of thrombosis
• Interfere either with platelet adhesion and/or aggregation (antiplatelet drugs)
GOAL: prevent initial clot formation
Antithrombotic therapy has had an enormous impact in several significant ways.
Heparin has made bypass surgery and dialysis possible by blocking clotting in external tubing.
Antithrombotic therapy has reduced the risk of blood clots in leg veins (also known as deep-vein thrombosis or DVT), a condition that can lead to death from pulmonary embolism (a clot that blocks an artery to the lungs) by more than 70 percent. And most importantly,
it has markedly reduced death from heart attacks, the risk of stroke in people with heart irregularities (atrial fibrillation), and the risk of major stroke in patients with mini-strokes.
Normally, blood flows through our arteries and veins smoothly and efficiently, but if a clot, or thrombus, blocks the smooth flow of blood, the result – called thrombosis – can be serious and even cause death. Diseases arising from clots in blood vessels include heart attack and stroke, among others. These disorders collectively are the most common cause of death and disability in the developed world. We now have an array of drugs that can be used to prevent and treat thrombosis – and there are more on the way – but this was not always the case.
The most important components of a thrombus are fibrin and platelets. Fibrin is a protein that forms a mesh that traps red blood cells, while platelets, a type of blood cell, form clumps that add to the mass of the thrombus. Both fibrin and platelets stabilize the thrombus and prevent it from falling apart. Fibrin is the more important component of clots that form in veins, and platelets are the more important component of clots that form in arteries where they can cause heart attacks and strokes by blocking the flow of blood in the heart and brain, respectively, although fibrin plays an important role in arterial thrombosis as well.
There are two classes of antithrombotic drugs: anticoagulants and antiplatelet drugs. Anticoagulants slow down clotting, thereby reducing fibrin formation and preventing clots from forming and growing. Antiplatelet agents prevent platelets from clumping and also prevent clots from forming and growing.
Anticoagulant Drugs
The anticoagulants heparin and dicumarol were discovered by chance, long before we understood how they worked. Heparin was first discovered in 1916 by a medical student at The Johns Hopkins University who was investigating a clotting product from extracts of dog liver and heart. In 1939, dicumarol (the precursor to warfarin) was extracted by a biochemist at the University of Wisconsin from moldy clover brought to him by a farmer whose prize bull had bled to death after eating the clover.
Both of these anticoagulants have been used effectively to prevent clots since 1940. These drugs produce a highly variable anticoagulant effect in patients, requiring their effect to be measured by special blood tests and their dose adjusted according to the results. Heparin acts immediately and is given intravenously (through the veins). Warfarin is swallowed in tablet form, but its anticoagulant effect is delayed for days. Therefore, until recently, patients requiring anticoagulants who were admitted to a hospital were started on a heparin infusion and were then discharged from the hospital after five to seven days on warfarin.
In the 1970s, three different groups of researchers in Stockholm, London, and Hamilton, Ontario, began work on low-molecular-weight heparin (LMWH). LMWH is produced by chemically splitting heparin into one-third of its original size. It has fewer side effects than heparin and produces a more predictable anticoagulant response. By the mid 1980s, LMWH preparations were being tested in clinical trials, and they have now replaced heparin for most indications. Because LMWH is injected subcutaneously (under the skin) in a fixed dose without the need for anticoagulant monitoring, patients can now be treated at home instead of at the hospital.
With the biotechnology revolution has come genetically engineered “designer” anticoagulant molecules that target specific clotting enzymes. Anti-clotting substances and their DNA were also extracted from an array of exotic creatures (ticks, leeches, snakes, and vampire bats) and converted into drugs by chemical synthesis or genetic engineering. Structural chemists next began to fabricate small molecules designed to fit into the active component of clotting enzymes, like a key into a lock.
The first successful synthetic anticoagulants were fondaparinux and bivalirudin. Bivalirudin, a synthetic molecule based on the structure of hirudin (the anti-clotting substance found in leeches), is an effective treatment for patients with heart attacks. Fondaparinux is a small molecule whose structure is based on the active component of the much larger LMWH and heparin molecules. It has advantages over LMWH and heparin and has recently been approved by the FDA. Newer designer drugs that target single clotting factors and that can be taken by mouth are undergoing clinical testing. If successful, we will have safer and more convenient replacements for warfarin, the only oral anticoagulant available for more than 60 years.
Antiplatelet Drugs
Blood platelets are inactive until damage to blood vessels or blood coagulation causes them to explode into sticky irregular cells that clump together and form a thrombus. The first antiplatelet drug was aspirin, which has been used to relieve pain for more than 100 years. In the mid-1960s, scientists showed that aspirin prevented platelets from clumping, and subsequent clinical trials showed that it reduces the risk of stroke and heart attack. In 1980, researchers showed that aspirin in very low doses (much lower than that required to relieve a headache) blocked the production of a chemical in platelets that is required for platelet clumping. During that time, better understanding of the process of platelet clumping allowed the development of designer antiplatelet drugs directed at specific targets. We now have more potent drugs, such as clopidogrel, dipyridamole, and abciximab. These drugs are used with aspirin and effectively prevent heart attack and stroke; they also prolong the lives of patients who have already had a heart attack.
Fibrinolytic therapy is used in selected patients with venous thromboembolism. For example, patients with massive or submassive PE can benefit from systemic or catheter-directed fibrinolytic therapy. The latter can also be used as an adjunct to anticoagulants for treatment of patients with extensive iliofemoral-vein thrombosis.
Arterial and venous thrombi are composed of platelets and fibrin, but the proportions differ.
Arterial thrombi are rich in platelets because of the high shear in the injured arteries. In contrast,
venous thrombi, which form under low shear conditions, contain relatively few platelets and are predominantly composed of fibrin and trapped red cells.
Because of the predominance of platelets, arterial thrombi appear white, whereas venous thrombi are red in color, reflecting the trapped red cells.
BioTrace Medical, Inc., a venture backed company based in San Carlos, Calif., is dedicated to reinventing temporary pacing to improve patient outcomes and reduce hospital costs.
FDA Clears Temporary Pacing Technology for Transcatheter Aortic Valve and EP Procedures
The BioTrace Medical Tempo temporary pacing lead is designed to reduce complications and hospital length of stay
The Tempo Lead represents the first major advance in temporary pacing since the technology was introduced decades ago,” said Susheel Kodali, M.D., director of the Heart Valve Program at the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York. “As a critical component of every TAVR procedure, temporary leads are integral to successful clinical outcomes for patients. I am excited about the potential of this technology and look forward to using it in my practice.”
Results of the first-in-human study of the technology will be presented at the annual Transcatheter Cardiac Therapeutics (TCT) conference in Washington, D.C. on Sunday, Oct. 30, at 10:59 a.m. eastern time in Room 209, Level 2.
“FDA clearance is an exciting milestone for BioTrace,” said Laura Dietch, CEO of BioTrace Medical. “We are pleased to bring this important innovation to the significant and growing number of patients needing better temporary pacing options to minimize risks and life-threatening complications. We look forward to launching in select U.S. centers in the coming weeks.”
December 19, 2016 — BioTrace Medical Inc. announced the first commercial use of the company’s Tempo Temporary Pacing Lead since U.S. Food and Drug Administration (FDA) 510(k) clearance in October.
The first cases involved patients undergoing transcatheter aortic valve replacement (TAVR) procedures and were performed by James Harkness, M.D., interventional cardiologist, and Brian K. Whisenant, M.D., medical director of the Structural Heart Disease Program at Intermountain Medical Center in Salt Lake City, Utah, and Susheel Kodali, M.D., director of the Heart Valve Program at Columbia University Medical Center/New York Presbyterian Hospital.
BioTrace Medical’s Tempo Lead is for use in procedures in which
Temporary pacing is indicated, including
TAVR and
Electrophysiology (EP) procedures.
The lead is designed for secure and stable cardiac pacing with the goal of reducing complications and allowing patients to ambulate sooner after procedures.
“The Tempo Lead is designed to alleviate the risks associated with lead dislodgement and inconsistent pacing, providing a safer option for patients.”
Temporary leads are used in more than 350,000 procedures each year, a number that is growing rapidly as the population ages and TAVR becomes increasingly common. The temporary pacing lead, a small catheter with two electrodes, is placed in the right ventricle of the heart through a vein in the groin or neck. The lead is then connected to an external pacemaker allowing a physician to monitor and control a patient’s heart rate for several days.
Watch the video “The Evolution of TAVR Technology.” Interview with Juan Granada, M.D., executive director and chief scientific officer of the Cardiovascular Research Foundation’s Skirball Center for Innovation, at the Transcatheter Valve Therapies 2015 meeting.
Watch the video “TAVR Beats Surgery — Top News From ACC.16.” Dr. Vinod Thourani, professor of surgery, Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine and a co-investigator for the PARTNER II Trial, discusses the biggest news item from ACC.16 — the Sapien 3 TAVR device performed better that surgical aortic valve replacement.
Watch the video “CoreValve Trumps Surgical Valve Replacement — TVT 2015.” Interview with Michael Reardon, M.D., professor of cardiothoracic surgery at DeBakey Heart and Vascular Center, and chairman of the patient screening committee, CoreValve U.S. pivotal trial, at the Transcatheter Valve Therapies 2015 meeting.
Most interventional and cardiac surgical experts say TMVR will be the next frontier in minimally invasive structural heart interventions. With the success and rapid growth of TAVR, there is an immense anticipation that TMVR will have an even greater impact in cardiology. This has translated into more than $2.5 billion being spent in the past year by vendors purchasing start-up TMVR companies, while less than 50 patients have actually been treated using these technologies, said Michael Mack, M.D., medical director, cardiovascular surgery, Baylor Health Care System and chairman of The Heart Hospital Baylor Plano Research Center.
However, the mitral valve involves much more complex anatomy than the aortic valve, so the devices, imaging for procedural planning and guidance will be much more sophisticated than what is used for TAVR. Among the challenges are: fixation of a device to the very small landing zone of the mitral annulus; avoiding the left ventricular outflow tract (LVOT); avoiding compression of the atrioventricular (AV) node; avoiding the papillary muscle and chordae tendineae; ensuring the device seals properly to avoid paravalvular regurgitation; and the device needs to be able to adapt to remodeling of the anatomy. There are more than 20 TMVR devices in development. The majority of these valves utilize a self-expanding nitinol frame that engages both sides of the native mitral valve annulus for fixation, similar to Amplatzer septal closure devices.
The companies with first-in-human TMVR implants include Tendyne, Neovasc and Edwards Lifesciences’ Fortis and Sapien XT devices. The Neovasc Tiara, Tendyne Bioprosthetic Mitral Valve and CardiAQ Valve Technologies TMVR system all have been granted FDA conditional investigational device exemption (IDE) studies.
Watch the video “Transcatheter Mitral Valve Repair Technologies.” An interview with Ted Feldman, M.D., FACC, MSCAI, FESC, cardiac cath lab director, Evanston Hospital, North Shore Health System, and principle investigator, Everest II MitraClip U.S. pivotal trial, at the Transcatheter Valve Therapies 2015 meeting.
Advancements in TAVR and TMVR Technologies at TCT 2016
Watch the video VIDEO “Transcatheter Valve Technology Advancements at TCT 2016.” This is an interview Torsten Vahl, M.D., about advancements in transcatheter valve repair technology, including new devices for the aortic, mitral and tricuspid valves. Vahl is director of experimental and translational research and assistant professor of medicine, Columbia University Medical Center, Center for Interventional Vascular Therapy.
Watch the video “VIDEO: Transcatheter Mitral Valve Technology, Anatomical Challenges.” A discussion with Juan Granada, M.D., about transcatheter mitral valve advancements and device challenges at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 annual meeting. Granada is executive director and chief scientific officer of the Cardiovascular Research Foundation’s Skirball Center for Innovation.
The presence of any Valvular Heart Disease (VHD) did not influence the comparison of Dabigatran [Pradaxa, Boehringer Ingelheim] with Warfarin
Reporter: Aviva Lev-Ari, PhD, RN
UPDATED on 10/22/2018
Dabigatran (Pradaxa) was no better than aspirin for prevention of recurrent stroke among patients with an embolic stroke of undetermined source in the RE-SPECT ESUS trial reported at the World Stroke Congress.
Pradaxa® (dabigatran etexilate)
Clinical experience of Pradaxa® equates to over 9 million patient-years in all licensed indications worldwide. Pradaxa® has been in the market for more than ten years and is approved in over 100 countries.15
Currently approved indications for Pradaxa® are:16,17
Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and a risk factor for stroke
Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery or total knee replacement surgery
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and recurrent PE in adults
Dabigatran, a direct thrombin inhibitor (DTI), was the first widely approved drug in a new generation of direct oral anticoagulants, available to target a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.18,19,20
REFERENCES
16 Pradaxa® US Prescribing Information, 2018.
17 Pradaxa® European Summary of Product Characteristics, 2018.
18 Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
19 Di Nisio M. et al. Direct thrombin inhibitors. N Engl J Med.2005;353:1028–40.
20 Stangier J. et al. Pharmacokinetic Profile of the Oral Direct Thrombin Inhibitor Dabigatran Etexilate in Healthy Volunteers and Patients Undergoing Total Hip Replacement. J Clin Pharmacol. 2005;45:555–63
Event Rate and Outcome Risk, With vs Without Valvular Heart Disease
Outcome
Valvular heart disease, event rate/y, %
No valvular heart disease, event rate/y, %
HR (95% CI)*
P
Stroke, systemic embolic event
1.61
1.41
1.09 (0.88–1.33)
0.43
Major bleeding
4.36
2.84
1.32 (1.16–1.33)
<0.001
Intracranial hemorrhage
0.51
0.41
1.20 (0.83–1.74)
0.32
All-cause mortality
4.45
3.67
1.09 (0.96–1.23)
0.18
*Adjusted using propensity scores
ORIGINAL RESEARCH ARTICLE
Comparison of Dabigatran versus Warfarin in Patients with Atrial Fibrillation and Valvular Heart Disease: The RE-LY Trial
Michael D. Ezekowitz, Rangadham Nagarakanti, Herbert Noack, Martina Brueckmann, Claire Litherland, Mark Jacobs, Andreas Clemens,Paul A. Reilly, Stuart J. Connolly, Salim Yusuf and Lars Wallentin
stroke or systemic embolism (SEE) rates (HR 1.09; 95% CI 0.88-1.33).
For D110 patients, major bleed rates were lower than warfarin (HR 0.73; 95% CI 0.56-0.95 with and HR 0.84; 95% CI 0.71-0.99 without VHD) and
For D150 similar to warfarin in patients with (HR 0.82; 95% CI 0.64-1.06) or without VHD (HR 0.98; 95% CI 0.83-1.15).
For D150 patients stroke/SEE rates were lower versus warfarin with (HR 0.59; 95% CI 0.37-0.93) and without VHD (HR 0.67; 95% CI 0.52-0.86) and similar to warfarin for D110 irrespective of presence of VHD (HR 0.97 CI 0.65-1.45 and 0.85 CI 0.70-1.10).
For intracranial bleeds and death rates for D150 and D110 were lower vs warfarin independent of presence of VHD.
Conclusions—The presence of any VHD did not influence the comparison of dabigatran with warfarin.
The registry study — the preliminary results of which were presented at the Transcatheter Cardiovascular Therapeutics meeting in 2015 — included 583 high-risk (65%) or inoperable patients (35%) who got TAVR with the Sapien 3 device between 2013 and 2014. Procedures were performed via the transfemoral (84%) or transapical/transaortic routes (16%).
On multivariable adjustment, the predictors of 1-year mortality were
alternative access (hazard ratio [HR] 2.06, 95% CI 1.26-3.36),
moderate paravalvular leak (HR 3.75, 95% CI 1.57-8.96), and
disabling stroke (HR 10.33, 95% CI 4.62-233.09).
“Even with the low rate of moderate paravalvular leak rate, they found an association with 1 year mortality,” commented Kappetein. “Moderate paravalvular leak is bad for a patient!”
Within 30 days, overall stroke and disabling stroke occurred at frequencies of 1.4% and 0.9%, respectively. Between 1 month and 1 year, these rates were 4.3% and 2.4%.
Généreux appeared to be at ease with the 1-year stroke rate, adding that “this reflects it being a high-risk population.”
In order to bring mortality and stroke rates even lower, he suggested that clinicians “focus on other strategies such as anticoagulation and other medical or device therapies like left atrial appendage closure.”
Nearly all patients improved enough to move out of New York Heart Association class three and four after the procedure (90.1% at baseline versus 7.7% at 1 year, P<0.0001). Self-reported quality of life similarly improved on the Kansas City Cardiomyopathy Questionnaire, with average scores rising from 46.9 to 72.4 at 1 year (P<0.0001).
“A high-risk population is difficult because patients may have mortality related to a comorbidity such as infection and heart failure. That being said, there is still room for improvement in the care of patients beyond the device choice,” Généreux said, suggesting that appropriate anticoagulation is key.
For now, “the combination of new design features of Sapien 3, procedural improvements, operator experience and improved patient selection have all contributed to a low rate of important adverse events (including stroke) and a high rate of 1-year survival in high-risk and inoperable patients with severe aortic stenosis,” Herrmann and colleagues concluded.
One-Year Clinical Outcomes With SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients With Severe Aortic Stenosis
Howard C. Herrmann, Vinod H. Thourani, Susheel K. Kodali, Raj R. Makkar, Wilson Y. Szeto, Saif Anwaruddin, Nimesh Desai, Scott Lim, S. Chris Malaisrie, Dean J. Kereiakes, Steven Ramee, Kevin L. Greason, Samir Kapadia, Vasilis Babaliaros, Rebecca T. Hahn, Philippe Pibarot,Neil J. Weissman, Jonathon Leipsic, Brian K. Whisenant, John G. Webb, Michael J. Mack and Martin B. Leon and For the PARTNER Investigators
Background: In the initial PARTNER trial (Placement of Aortic Transcatheter Valves) of transcatheter aortic valve replacement for high-risk (HR) and inoperable patients, mortality at 1 year was 24% in HR and 31% in inoperable patients. A recent report of the 30-day outcomes with the low-profile SAPIEN 3 transcatheter aortic valve replacement system demonstrated very low rates of adverse events, but little is known about the longer-term outcomes with this device.
Methods: Between October 2013 and September 2014, 583 HR (65%) or inoperable (35%) patients were treated via the transfemoral (84%) or transapical/transaortic (16%) access route at 29 US sites. Major clinical events at 1 year were adjudicated by an independent clinical events committee, and echocardiographic results were analyzed by a core laboratory.
Results: Baseline characteristics included age of 83 years, 42% female, and median Society of Thoracic Surgeons score of 8.4%. At the 1-year follow-up, survival (all-cause) was 85.6% for all patients, 87.3% in the HR subgroup, and 82.3% in the inoperable subgroup. Survival free of all-cause and cardiovascular mortality in the transfemoral patients from the HR cohort was 87.7% and 93.3%, respectively. There was no severe paravalvular leak. Moderate paravalvular leak (2.7%) was associated with an increase in mortality at 1 year, whereas mild paravalvular leak had no significant association with mortality. Symptomatic improvement as assessed by the percentage of patients in New York Heart Association class III and IV (90.1% to 7.7% at 1 year; P<0.0001) and by Kansas City Cardiomyopathy Questionnaire overall summary score (improved from 46.9 to 72.4;P<0.0001) was marked. Multivariable predictors of 1-year mortality included alternative access, Society of Thoracic Surgeons score, and disabling stroke.
Conclusions: In this large, adjudicated registry of SAPIEN 3 HR and inoperable patients, the very low rates of important complications resulted in a strikingly low mortality rate at 1 year. Between 30 and 365 days, the incidence of moderate paravalvular aortic regurgitation did not increase, and no association between mild paravalvular leak and 1-year mortality was observed, although a small increase in disabling stroke occurred. These results, which likely reflect device iteration and procedural evolution, support the use of transcatheter aortic valve replacement as the preferred therapy in HR and inoperable patients with aortic stenosis.
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