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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
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.
Pulmonary Valve Replacement and Repair: Valvuloplasty Device – Tissue (bioprosthetic) or mechanical valve; Surgery type – Transcatheter Pulmonary Valve Replacement (TPVR) vs Open Heart, Valve Repair – Commissurotomy, Valve-ring Annuloplasty
Reporter: Aviva Lev-Ari, PhD, RN
Outcomes of Pulmonary Valve Replacement in 170 Patients With Chronic Pulmonary Regurgitation After Relief of Right Ventricular Outflow Tract Obstruction
Implications for Optimal Timing of Pulmonary Valve Replacement
Cheul Lee, Yang Min Kim, Chang-Ha Lee, Jae Gun Kwak, Chun Soo Park, Jin Young Song, Woo-Sup Shim, Eun Young Choi, Sang Yun Lee and Jae Suk Baek
Objectives The objectives of this study were to evaluate outcomes of pulmonary valve replacement (PVR) in patients with chronic pulmonary regurgitation (PR) and to better define the optimal timing of PVR.
Background Although PVR is effective in reducing right ventricular (RV) volume overload in patients with chronic PR, the optimal timing of PVR is not well defined.
Methods A total of 170 patients who underwent PVR between January 1998 and March 2011 for chronic PR were retrospectively analyzed. To define the optimal timing of PVR, pre-operative and post-operative cardiac magnetic resonance imaging (MRI) data (n = 67) were analyzed.
Results The median age at the time of PVR was 16.7 years. Follow-up completeness was 95%, and the median follow-up duration was 5.9 years. Overall and event-free survival at 10 years was 98% and 70%, respectively. Post-operative MRI showed significant reduction in RV volumes and significant improvement in biventricular function. Receiver-operating characteristic curve analysis revealed a cutoff value of 168 ml/m2 for non-normalization of RV end-diastolic volume index (EDVI) and 80 ml/m2 for RV end-systolic volume index (ESVI). Cutoff values for optimal outcome (normalized RV volumes and function) were 163 ml/m2 for RV EDVI and 80 ml/m2 for RV ESVI. Higher pre-operative RV ESVI was identified as a sole independent risk factor for suboptimal outcome.
Conclusions Midterm outcomes of PVR in patients with chronic PR were acceptable. PVR should be considered before RV EDVI exceeds 163 ml/m2 or RV ESVI exceeds 80 ml/m2, with more attention to RV ESVI.
Relief of right ventricular (RV) outflow tract obstruction in tetralogy of Fallot or similar physiology often results in pulmonary regurgitation (PR). The resultant chronic volume overload can lead to RV dilation, biventricular dysfunction, heart failure symptoms, arrhythmias, and sudden death (1–5). Pulmonary valve replacement (PVR) can lead to improvement in functional class and a substantial decrease or normalization of RV volumes (6,7). Other potential benefits of PVR are improvement in exercise capacity (8) and decrease in QRS duration (9). However, benefits of PVR have to be weighed against the risks of this procedure. Although operative mortality of PVR is low (6), post-operative morbidities are not negligible (10) and patients are exposed to the risk of repeat PVR (11–13). PVR is indicated when patients become symptomatic or at risk for life-threatening arrhythmias (14). For asymptomatic patients, there have been debates regarding the optimal timing of PVR (15–19). Magnetic resonance imaging (MRI) is a gold standard for evaluating RV volumes and function (20), and these MRI parameters can be used to decide the indications for PVR. Many studies dealing with changes in MRI parameters after PVR have been reported (7–9,21–26). However, most of them have a limitation of small patient numbers, and there are few studies suggesting the optimal timing of PVR (7–9). The objectives of this study were to evaluate outcomes of PVR performed in patients with chronic PR and to better define the optimal timing of PVR by analyzing MRI parameters.
Pulmonary valve disease treatment depends on the severity of your condition, whether or not you’re experiencing signs and symptoms, and if your condition is getting worse.
Many types of pulmonary valve disease are caused by heart conditions present at birth (congenital heart disease). Types of pulmonary valve disease that may require treatment with pulmonary valve repair or pulmonary valve replacement include:
Pulmonary valve regurgitation is a leaky pulmonary valve. The leaky valve allows blood to flow backward into the heart rather than directly to the lungs for oxygen.
The most common cause of pulmonary valve regurgitation is pulmonary hypertension. Other causes of pulmonary valve regurgitation are congenital heart disease (specifically, tetralogy of Fallot or congenital pulmonary valve stenosis), bacterial infection of the heart (infective endocarditis), complications after heart surgery, and rarely rheumatic fever.
Pulmonary valve stenosis occurs when the pulmonary valve becomes thickened or obstructed, which makes it harder for it to open properly and for the heart to pump blood into the pulmonary artery and to the lungs.
The cause of pulmonary valve stenosis is usually unknown. It often affects children and may be caused by congenital heart disease or an infection in the mother during pregnancy. It can also occur in adults as a result of a rare type of cancer that affects the heart (carcinoid heart disease).
Pulmonary atresia is a congenital heart defect in which a child is born without a well-defined pulmonary valve. In pulmonary atresia, blood can’t flow from the right ventricle into the pulmonary artery. The only blood flow to the lungs is through an open passageway between the pulmonary artery and the main artery supplying blood to the body (aorta).
The cause is usually unknown. Children born with pulmonary atresia may also have other heart defects.
For some people with mild pulmonary valve disease without symptoms, careful monitoring under a doctor’s supervision may be all that’s needed.
But in many cases, pulmonary valve disease and dysfunction progress in adulthood and get worse without medical treatment. Most pulmonary valve conditions are mechanical problems that cannot be adequately treated with medications alone and will eventually require surgery to reduce symptoms and the risk of complications, such as heart failure, or death due to advanced heart failure or sudden cardiac arrest.
The decision to repair or replace a damaged pulmonary valve depends on many factors, including:
The severity of your pulmonary valve disease
Your age and overall health
Whether you need heart surgery to correct another heart problem in addition to pulmonary valve disease, such as another valve surgery, for example, tricuspid valve repair or replacement, so both conditions can be treated at once
In general and whenever possible, heart valve repair is the preferred option because it is associated with a lower risk of infection, preserves valve strength and function, and eliminates the need to take blood-thinning medications, which may be necessary with valve replacement.
But not all valves can be repaired, and heart valve repair surgery is often harder to do than valve replacement. Your best option will depend on your individual situation as well as the expertise and experience of your health care team.
Pulmonary valve repair and pulmonary valve replacement may be performed via traditional open-heart surgery, which involves a cut (incision) in the chest (sternotomy), or via minimally invasive methods that involve smaller incisions in the chest (hybrid approach) or a catheter-based approach.
What type of procedure you have depends on the severity of your pulmonary valve disease, overall health and whether you need additional heart surgery to treat other issues.
Transcatheter Pulmonary Valve Replacement (TPVR) at Cleveland Clinic
A number of patients with congenital heart disease have problems with their pulmonary valve, either since birth, or after cardiac surgery. For many patients, a valve replacement may be recommended.
Until the last decade replacing a faulty pulmonary valve could only be done with open heart surgery. Because all surgically implanted valves have a limited life-span, patients faced many surgeries over the course of their life to replace the pulmonary valve. The percutaneous, non-surgical option to replace the pulmonary valve has revolutionized the care of these patients.
Image Source: Medtronic, 2017
Who can benefit from TPVR?
Patients who may benefit from a transcatheter pulmonary valve include those with:
Tetralogy of Fallot who have had prior surgery but now have a leaky or narrowed pulmonary valve, especially if they have undergone a prior surgical replacement.
Patients with other underlying diagnoses who also have a surgically implanted pulmonary valve (such as a homograft or a bioprosthetic valve) that is no longer working well; including patients with truncus arteriosus, patients with aortic valve disease who have had a Ross procedure, and some patients with pulmonary stenosis or atresia.
The goals of transcatheter pulmonary valve replacement is to replace the pulmonary valve non-surgically and decrease the number of heart surgeries a patient will need over their life-time.
Evaluation
To see if you are a possible candidate for treatment with the transcatheter pulmonary valve, you’ll have a comprehensive evaluation by a multidisciplinary team. The evaluation focuses on the patient’s condition, anatomy, and management options and will include:
Physical exam.
Diagnostic tests including an echocardiogram, cardiac MRI, or cardiac CT scan (the latter if you cannot have an MRI due to, for example, having a pacemaker).
Treatment
There are 2 valves currently approved by the FDA for this indication, the Melody valve and the Edwards SAPIEN XT valve. Both are tissue valves that are sutured to a stent, which is a thin metal cylinder that is mounted on a balloon catheter.
TPVR Procedure
The procedure is performed in a pediatric and adult congenital cardiac catheterization lab by an interventional cardiologist with expertise in congenital cardiac interventions, utilizing fluoroscopy and angiography to see the anatomy and evaluate the function of the heart valves.
A catheter is placed through a small incision into the femoral vein (in the groin) or the jugular vein in the neck.
A compressed tissue heart valve is placed on a balloon catheter; advanced through the vein to the heart, and is positioned directly inside the diseased pulmonary valve. Once in position, the balloon is inflated expanding the stent and the valve is secured in place. The new valve immediately begins to work. The catheter is then removed.
Patients are observed overnight and discharged the following morning. Usually you can return to your normal activities in 7 days.
Physicians with expertise in catheter interventions for congenital heart disease have been performing this procedure at the Cleveland Clinic since 2010. Both the Melody valve and the Edwards SAPIEN valve have been used, depending on the size needed for a particular patient. No patient with underlying congenital heart disease has had a severe complication and no patient has required removal of the valve to date.
From The Illustrated Field Guide to Congenital Heart Disease and Repair – Second Edition courtesy of Scientific Software Solutions Inc.
The valves in your heart may be damaged due to infection, rheumatic heart disease or birth (congenital) defects. The affected valve leaflets (cusps) may grow thick and brittle from scar tissue or calcium deposits, or they may become thin and weak resulting in an inefficient valve.
There are several terms referring to valve disease.
Stenosis – the opening of the valve becomes smaller, thus allowing less blood to flow through.
Regurgitation/Insufficiency (leaky valve) – the valve does not close properly and allows blood to flow backward as well as forward in the heart.
How will I feel?
Due to the damaged valve, your heart must work harder to pump blood throughout the body. You may tire easily and feel short of breath with less activity or exercise. You may experience an irregular heartbeat due to over-stretching of the heart muscle as in mitral stenosis, or dizziness and near fainting due to decreased blood flow to the brain as in aortic stenosis.
How will my valve be fixed?
Depending on the extent of your valve disease, you may need to have the valve repaired or replaced. To repair the valve, your surgeon may perform a commissurotomy or implant a valve ring. A commissurotomy is performed for a tight valve (stenosis). The valve leaflets are cut to loosen the valve slightly, allowing blood to pass easily. Another type of valve repair is a valve ring annuloplasty, which is sewn in place when the valve is leaking (regurgitant or insufficient). The valve leaflets are tucked in place with the ring.
Often the valve cannot be repaired and the surgeon must replace the damaged valve with a tissue (bioprosthetic) or mechanical valve. Tissue valve are valves from animals (e.g., cow, pig). They generally do not require long-term anticoagulation and are not as durable as mechanical valves. Mechanical valves are made from materials such as plastic or metal. They require long-term anticoagulation and are considered extremely durable, lasting longer than tissue valves.
Your surgeon will discuss the need for repair or replacement of the valve with you prior to surgery as well as the type of valve (tissue or mechanical) should replacement be necessary.
Annuloplasty Ring
Tissue Valve
Mechanical Valve
Valve Replacement Surgery: What else should I know?
Prevention of Valve Infection
To prevent an infection (endocarditis) from occurring around the new heart valve or ring, you should receive antibiotics before having any procedures that could permit bacteria to enter your body. Among these procedures are:
All dental procedures (cleaning, filling, removing teeth, root canals, gum or ulcer treatment). You may use dental floss, In fact, we encourage you to reduce tartar with any approved method.
Surgical procedures such as colonoscopy, cystoscopy, or other surgical procedures.
Annuloplasty Ring
Tissue Valve
Mechanical Valve
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