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Palmaz, Pinchuk, Schatz, Simpson and Yock are the 10th recipients of the Russ Prize for innovations leading to the widespread adoption of PCI at NAE Gala Ceremony, 2/20/2019, WashDC
Reporter: Aviva Lev-Ari, PhD, RN
Article ID #262: Palmaz, Pinchuk, Schatz, Simpson and Yock are the 10th recipients of the Russ Prize for innovations leading to the widespread adoption of PCI at NAE Gala Ceremony, 2/20/2019, WashDC. Published on 1/16/2019
WordCloud Image Produced by Adam Tubman
National Academy of Engineering, Ohio University Award 2019 Russ Prize
Five interventional cardiologists awarded biennial $500,000 prize for innovations leading to the widespread adoption of PCI
January 3, 2019 — Ohio University and the National Academy of Engineering announced the 2019 Fritz J. and Dolores H. Russ Prize will be given to Julio Palmaz, Leonard Pinchuk, John Simpson, Richard Schatz and Paul Yock for innovations leading to the widespread adoption of percutaneous coronary intervention (PCI), also known as angioplasty with stent or coronary angioplasty. The $500,000 biennial prize, which recognizes a bioengineering achievement that significantly improves the human condition, cites PCI for “seminal contributions to coronary angioplasty, enabling minimally invasive treatment of advanced coronary artery disease.”
“The Russ Prize recipients personify engineering creations that advance health and healthcare every day,” said NAE President C. D. Mote, Jr. “The PCI makes a remarkable contribution to patient well-being, helping millions afflicted with advanced coronary artery disease and significant angina. “
Ohio University alumnus and esteemed engineer Fritz Russ, BSEE ’42, HON ‘75, and his wife, Dolores Russ, established the biennial prize in 1999 with a multimillion dollar gift to Ohio University. They modeled it after the Nobel Prize, with the goal of recognizing bioengineering achievements worldwide that are in widespread use.
“This innovation — truly, sets of innovations — enables the treatment of coronary artery disease without the complexities, cost and risk of open heart surgery. Most of us have a friend or relative who has benefited greatly from angioplasty treatment,” said Russ College Dean Dennis Irwin. “These contributions have truly improved the human condition. Rewarding such innovations was the Russes’ intent.”
Percutaneous coronary intervention, also referred to as percutaneous transluminal coronary angioplasty (PTCA), is a minimally invasive procedure that uses a catheter to place a small structure called a stent to open up blood vessels in the heart that have been narrowed by plaque buildup. PCI improves blood flow, thus decreasing heart-related chest pain, making patients feel better and increasing their ability to be active. Ten of millions of patients have benefited from PCI worldwide, and this procedure has replaced or significantly delayed the need for open heart coronary bypass surgery.
Julio C. Palmaz, inventor of the first U.S. Food and Drug Administration (FDA)-approved balloon-expandable vascular stent (1990), is Ashbel Smith Professor at the University of Texas Health Science Center in San Antonio and scientific adviser of Vactronix Scientific. The Palmaz stent is on display at the Smithsonian’s National Museum of American History in Washington, D.C. In 1994 he and Richard Schatz created a modified coronary stent — two Palmaz stents joined by a single connector — approved by the FDA as the first stent indicated for the treatment of failure of coronary balloon angioplasty. The Palmaz-Schatz stent became the gold standard for every subsequent stent submitted for FDA approval.
Leonard Pinchuk is an inventor and entrepreneur in biomedical engineering, with 128 U.S. patents and 90 publications. He has co-founded 10 companies where his major accomplishments include invention of the Nylon 12 angioplasty balloon, helical wire stent, modular stent-graft, a drug-eluting stent (Taxus), several biomaterials (Bionate and polystyrene-block-isobutylene-block-styrene [SIBS]), a novel glaucoma tube (InnFocus MicroShunt), and the next-generation intraocular lens. He is a Distinguished Research Professor of Biomedical Engineering at the University of Miami.
John Simpson has helped revolutionize the field of cardiology through innovations that fundamentally altered how physicians treat cardiovascular disease. In 1981 he created a new catheter system for coronary angioplasty with an independently steerable guidewire in the central lumen of the balloon catheter, patented as the over-the-wire balloon angioplasty catheter. He now focuses his efforts on the treatment of vascular disease through the development of new technologies combined with a new approach to optical imaging.
Richard Schatz is research director of cardiovascular interventions at the Scripps Heart, Lung and Vascular Center, and director of gene and stem cell therapy. He is a recognized international expert in interventional cardiology and has published and lectured extensively. His seminal work in coronary stents spurred a revolution in the treatment of coronary artery disease — over 2 million of them are placed annually worldwide, with an immeasurable impact on relieving mortality and morbidity, improving patients’ lives, and reducing healthcare costs.
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. He has authored over 300 peer-reviewed publications, chapters, and editorials and two textbooks, and holds over 50 U.S. patents. Yock 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.
“Ohio University is honored to join the National Academy of Engineering in recognizing these accomplished individuals, who have contributed to a bioengineering advancement that has enabled better health for heart patients across the world,” said Ohio University President M. Duane Nellis. “Their multi-disciplinary collaboration that lead to the development of PCI, a technology that has revolutionized coronary health, truly embraces the vision that Fritz and Dolores Russ had when creating the Russ Prize.”
Palmaz, Pinchuk, Schatz, Simpson and Yock are the 10th recipients of the Russ Prize. They will receive the award at a National Academy of Engineering gala ceremony in Washington, D.C., on Feb. 20, 2019
Changes in Levels of Sex Hormones and N-Terminal Pro–B-Type Natriuretic Peptide as Biomarker for Cardiovascular Diseases
Reporter and Curator: Dr. Sudipta Saha, Ph.D.
Considerable differences exist in the prevalence and manifestation of atherosclerotic cardiovascular disease (CVD) and heart failure (HF) between men and women. Premenopausal women have a lower risk of CVD and HF compared with men; however, this risk increases after menopause. Sex hormones, particularly androgens, are associated with CVD risk factors and events and have been postulated to mediate the observed sex differences in CVD.
B-type natriuretic peptides (BNPs) are secreted from cardiomyocytes in response to myocardial wall stress. BNP plays an important role in cardiovascular remodelling and volume homeostasis. It exerts numerous cardioprotective effects by promoting vasodilation, natriuresis, and ventricular relaxation and by antagonizing fibrosis and the effects of the renin-angiotensin-aldosterone system. Although the physiological role of BNP is cardioprotective, pathologically elevated N-terminal pro–BNP (NT-proBNP) levels are used clinically to indicate left ventricular hypertrophy, dysfunction, and myocardial ischemia. Higher NT-proBNP levels among individuals free of clinical CVD are associated with an increased risk of incident CVD, HF, and cardiovascular mortality.
BNP and NT-proBNP levels are higher in women than men in the general population. Several studies have proposed the use of sex- and age-specific reference ranges for BNP and NT-proBNP levels, in which reference limits are higher for women and older individuals. The etiology behind this sex difference has not been fully elucidated, but prior studies have demonstrated an association between sex hormones and NT-proBNP levels. Recent studies measuring endogenous sex hormones have suggested that androgens may play a larger role in BNP regulation by inhibiting its production.
Data were collected from a large, multiethnic community-based cohort of individuals free of CVD and HF at baseline to analyze both the cross-sectional and longitudinal associations between sex hormones [total testosterone (T), bioavailable T, freeT, dehydroepiandrosterone (DHEA), SHBG, and estradiol] and NT-proBNP, separately for women and men. It was found that a more androgenic pattern of sex hormones was independently associated with lower NT-proBNP levels in cross-sectional analyses in men and postmenopausal women.
This association may help explain sex differences in the distribution of NT-proBNP and may contribute to the NP deficiency in men relative to women. In longitudinal analyses, a more androgenic pattern of sex hormones was associated with a greater increase in NT-proBNP levels in both sexes, with a more robust association among women. This relationship may reflect a mechanism for the increased risk of CVD and HF seen in women after menopause.
Additional research is needed to further explore whether longitudinal changes in NT-proBNP levels seen in our study are correlated with longitudinal changes in sex hormones. The impact of menopause on changes in NT-proBNP levels over time should also be explored. Furthermore, future studies should aim to determine whether sex hormones directly play a role in biological pathways of BNP synthesis and clearance in a causal fashion. Lastly, the dual role of NTproBNP as both
a cardioprotective hormone and
a biomarker of CVD and HF, as well as
the role of sex hormones in delineating these processes,
should be further explored. This would provide a step toward improved clinical CVD risk stratification and prognostication based on
BLOG | DAVE FORNELL, DAIC EDITOR | DECEMBER 11, 2018
A 40,000 Foot View of Trends in Cardiology
I was recently asked about my thoughts on the big picture, over arching trends effecting cardiology. Here is the outline I gave them.
Cardiology Cost Drivers
Reimbursements from Centers for Medicare and Medicaid Services (CMS) and insurance providers drive trends for the adoption of new technologies. However, new technologies that can show empirical evidence for being able to improve outcomes at lower costs are being moved up for better payments. CMS and other insurers are also using a carrot and stick approach with increased use of CMS bundled payments. These give a flat fee for diagnosing and treating a heart attack or heart failure, rather than hospitals being paid for all the tests and procedures they did. This approach makes the hospitals want to find new ways to be more cost effective to increase their bottom lines to capture more of the bundled payment as revenue.
Heart failure makes up about a third or more of the costs to Medicare. This has caused CMS to look closely at what is driving costs, and really high readmission rates are mainly to blame. There are penalties or no reimbursements for patients who come back for repeat treatments because they were not managed properly the first time. New technologies to address heart failure and other chronic diseases are of major interest to DAIC readers. Many of these include information technology (IT) solutions, rather than treatment device technologies.
Other conditions like atrial fibrillation (AF) also drive up costs, so vendors are attempting to find better ways to diagnose and treat this condition. Current treatments are only effective in the first attempt in about 60 percent of patients.
Consolidation of Hospitals and Outside Physicians
This is a continuing trend where single hospitals or smaller hospital systems are being bought up by bigger fish to create economy of scale with larger healthcare systems. These often cover specific geographic areas and often cast a wide net to include some luminary hospitals, smaller community hospitals, immediate care centers and minute clinics inside drug partner pharmacies. Duplicate staff and services are sometimes eliminated after mergers and consolidation. Outside physicians, including cardiologists and radiologists, are also being brought into the fold as employees of the health systems, rather than the old model as outside contractors who have access to the hospital’s amenities.
Any techniques and technologies that can improve outcomes, cut costs, reduce hospital length of stay or prevent readmissions can capture hospital and cardiologist attention in today’s healthcare environment. There has been a massive movement over the past two decades away from traditional open heart or vascular surgical procedures to catheter-based interventional procedures. This includes improvements in the durability and complexity of percutaneous coronary intervention (PCI), reopening chronic total occlusions (CTOs), endovascular aortic repair (EVAR), expanded interest in treating peripheral artery disease (PAD), and structural heart cases that used to be the realm of the cardiac surgeon.
There is a major revolution and rapid uptake in transcatheter valve technologies to replace open heart surgery. Structural heart procedures to repair or replace failing heart valves have had positive clinical trial after positive trial over the last several years. Several key cardiac surgeons in the field say catheter based interventions will likely be the way of the future and surgical case volumes will see stead declines over the next decade.
The Role of Information Technology and AI in Cardiology
IT solutions are now increasingly being leveraged in more sophisticated ways since most hospitals have converted to integrated electronic medical records (EMRs) over the past decade. These allow all patient and departmental data to be accessible in one location. Analytics software is now being used to mine this data to identify workflow inefficiencies and areas to cut costs or improve charge capture. Clinical decision support (CDS) software to help hospitals and doctors better meet guideline-based care in all specialties is being introduced to help clinicians make better care decisions. This includes choosing appropriate tests and procedures in an effort to reduce costs or avoid tests that will not be reimbursed.
Artificial intelligence (AI) will be taking over many of the manual tasks for monitoring data and to answer questions more quickly. AI will also be used to alert administrators or doctors when it autonomously identifies a problem. Applications to watch also include AI to monitor population health in the background. This can identify patients at risk for various cardiovascular diseases before they present with any symptoms. The software also can identify patients who need extra care and counseling because of the high likelihood they will not be compliant with discharge orders and be readmitted. AI also will offer a second set of eyes on cardiac imaging to help identify anomalies or greatly reduce time by performing all the measurements automatically without human intervention.
This use of IT also includes patient portals to engage with patients and allow better access to their records and care. This is already starting to filter down to apps on smart phones to improve care, compliance with doctor’s orders and to aid diagnosis of conditions before they become problematic, such as heart failure and AF.
Cardiac Imaging Trends
Cardiac ultrasound (echo) remains the No.1 imaging modality in cardiology because of its broad availability, low cost and no radiation. However, computed tomography (CT) is poised to become the front-line imaging test for acute chest pain patients in the emergency department. It is also the gold standard for structural heart procedure planning, and the number of these cases is rapidly rising. CT fractional flow reserve (CT-FFR) technology is widely expected to become the main test for chest pain in the next decade, since it has the potential to save both time and money. CT-FFR also will become the primary gate-keeper to the cath lab to significantly lower, or possibly eliminate, the need for diagnostic catheter angiograms.
Cardiac MRI has seen numerous advances in recent years that cut imaging times by 50 percent and automate quantification, cutting the time to read and process these exams. MRI is expected to see and increase for cardiac exams in the coming years. MRI and CT-FFR may greatly reduce the number of nuclear exams, which are currently the gold standard for cardiac perfusion imaging.
Cardiac Medical Devices Pioneer, Earl E. Bakken, Medtronic Co-founder, the developer of the first external, battery-powered, transistorized pacemaker, died at 94 on 10/21/2018 in Hawaii
Reporter: Aviva Lev-Ari, PhD, RN
Article ID #258: Cardiac Medical Devices Pioneer, Earl E. Bakken, Medtronic Co-founder, the developer of the first external, battery-powered, transistorized pacemaker, died at 94 on 10/21/2018 in Hawaii. Published on 10/22/2018
WordCloud Image Produced by Adam Tubman
Earl Bakken was born to Florence and Osval Bakken on January 10, 1924, in Minneapolis. After serving as a radar instructor in World War II, Bakken earned a degree in electrical engineering at the University of Minnesota.
In the late 1950’s, Bakken developed the first external, wearable, battery-powered, transistorized heart pacemaker, and commercialized the first implantable pacemaker in 1960. Medtronic grew rapidly from there; today its medical products and devices improve the lives of two people every second.
Earl with five-year-old pacemaker recipient Lyla Koch in 1984
The business struggled, but while servicing medical equipment, Bakken and Hermundslie built relationships with doctors at university hospitals in Minneapolis. There they met C. Walton Lillehei, a young staff surgeon who would later become famous for pioneering open-heart surgery. Following a blackout in the Twin Cities that caused the death of an infant, Lillehei asked Bakken to come up with a solution. He responded by adapting a circuit described in Popular Electronics magazine to create the first external wearable, battery-powered pacemaker, replacing the large, alternating current-powered pacemakers that were in use at the time.
The Garage Gang
Standing: Dale Blosberg, Norman Hagfors, Earl Hatten. Seated: John Bravis, Earl Bakken, Louis Leisch
They expanded services to other medical technology. Then in 1960, the first implantable pacemaker was implanted in a human patient. Bakken and Hermundslie reached a licensing agreement with the inventors, giving their small company exclusive manufacturing and marketing rights to the device, and Medtronic took off.
“Earl always had a vision of healthcare of not being about devices, about drugs, but about restoring people to full health,” said former Medtronic CEO Bill George. “And so from the very start he was focused on not implanting a device, but enabling people to live a full active life and he delivered that point of view to all Medtronic employees through The Mission.
A lifelong aspiration came true for Bakken in 2013, when Medtronic Philanthropy launched The Bakken Invitation to honor people who received medical devices, and who made an impact on the lives of others, through service and volunteerism. Bakken, who in his later years became a medical device patient, with a pacemaker, coronary stents and insulin pump, was fond of asking patients what they planned to do with their gift of “extra life.” Each year Bakken met with the honorees. “Their stories are a powerful reminder that we can all give back-no matter our current situation,” he said after meeting them in 2014.
Earl with Bakken Invitation recipients in 2013
Every year in December, Medtronic employees gather to mark another Bakken inspiration — the employee holiday program. The company invites patients from all over the world to share their stories of how medical technology has improved their lives. Hundreds of employees fill the Medtronic conservatory for the event, while thousands of others listen or watch via Medtronic TV.
Live 12:00 – 1:00 P.M Mediterranean Diet and Lifestyle: A Symposium on Diet and Human Health : October 19, 2018
Reporter: Stephen J. Williams, Ph.D.
12.00 The Italian Mediterranean Diet as a Model of Identity of a People with a Universal Good to Safeguard Health?
Prof. Antonino De Lorenzo, MD, PhD.
Director of the School of Specialization in Clinical Nutrition, University of Rome “Tor Vergata”
It is important to determine how our bodies interacts with the environment, such as absorption of nutrients.
Studies shown here show decrease in life expectancy of a high sugar diet, but the quality of the diet, not just the type of diet is important, especially the role of natural probiotics and phenolic compounds found in the Mediterranean diet.
The WHO report in 2005 discusses the unsustainability of nutrition deficiencies and suggest a proactive personalized and preventative/predictive approach of diet and health.
Most of the noncommunicable diseases like CV (46%) cancer 21% and 11% respiratory and 4% diabetes could be prevented and or cured with proper dietary approaches
Italy vs. the US diseases: in Italy most disease due to environmental contamination while US diet plays a major role
The issue we are facing in less than 10% of the Italian population (fruit, fibers, oils) are not getting the proper foods, diet and contributing to as we suggest 46% of the disease
The Food Paradox: 1.5 billion are obese; we notice we are eating less products of quality and most quality produce is going to waste;
growing BMI and junk food: our studies are correlating the junk food (pre-prepared) and global BMI
modern diet and impact of human health (junk food high in additives, salt) has impact on microflora
Western Diet and Addiction: We show a link (using brain scans) showing correlation of junk food, sugar cravings, and other addictive behaviors by affecting the dopamine signaling in the substantia nigra
developed a junk food calculator and a Mediterranean diet calculator
the intersection of culture, food is embedded in the Mediterranean diet; this is supported by dietary studies of two distinct rural Italian populations (one of these in the US) show decrease in diet
Impact of diet: have model in Germany how this diet can increase health and life expectancy
from 1950 to present day 2.7 unit increase in the diet index can increase life expectancy by 26%
so there is an inverse relationship with our index and breast cancer
Environment and metal contamination and glyphosate: contribution to disease and impact of maintaining the healthy diet
huge problem with use of pesticides and increase in celiac disease
Cancer as a disease of the environment. Weinberg’s hallmarks of Cancer reveal how environment and epigenetics can impact any of these hallmarks.
Epigenetic effects
gene gatekeepers (Rb and P53)
DNA repair and damage stabilization
Heavy Metals and Dioxins:( alterations of the immune system as well as epigenetic regulations)
Asbestos and Mesothelioma: they have demonstrated that p53 can be involved in development of mesothelioma as reactivating p53 may be a suitable strategy for therapy
Diet, Tomato and Cancer
looked at tomato extract on p53 function in gastric cancer: tomato extract had a growth reduction effect and altered cell cycle regulation and results in apoptosis
RBL2 levels are increased in extract amount dependent manner so data shows effect of certain tomato extracts of the southern italian tomato ( )
Antonio Giordano: we tested whole extracts of almost 30 different varieties of tomato. The tomato variety with highest activity was near Ravela however black tomatoes have shown high antitumor activity. We have done a followup studies showing that these varieties, if grow elsewhere lose their antitumor activity after two or three generations of breeding, even though there genetics are similar. We are also studying the effects of different styles of cooking of these tomatoes and if it reduces antitumor effect
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
Reporter: Aviva Lev-Ari, PhD, RN
UPDATED on 4/13/2023
TAVR vs. SAVR in patients with pure aortic regurgitation: Key insights from a new Cleveland Clinic study
Overall, TAVR and SAVR patients were linked to comparable in-hospital mortality, 30-day mortality and 30-day stroke rates. After a median follow-up period of 31 months, however, TAVR patients were associated with a higher mortality rate and higher risk of redo aortic valve replacement.
“The poorer intermediate-term outcomes with TAVR in our study could potentially be due to residual unmeasured differences and surgical risk between the two groups, but could also be related to the anatomical differences between pure severe AR and aortic stenosis,” the authors wrote. “The increased prevalence of bicuspid leaflets and annular/aortic root dilation in AR patients, with relatively less leaflet and annular calcification, pose a challenge with transcatheter heart valve anchoring and adequate positioning and increase the risk of paravalvular leak and device embolization. Abnormal hemodynamics across prosthetic valves and paravalvular leakage, whether mild or moderate/severe, are known predictors of poor outcomes, including death. The recommendation to oversize the THV during implantation is also associated with increased risk of aortic rupture and conversion to open heart surgery, a complication that was observed in 1% of TAVR patients in our study.”
5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients
Thomas G. Gleason, Michael J. Reardon, Jeffrey J. Popma, G. Michael Deeb, Steven J. Yakubov, Joon S. Lee, Neal S. Kleiman, Stan Chetcuti, James B. Hermiller Jr., John Heiser, William Merhi, George L. Zorn III, Peter Tadros, Newell Robinson, George Petrossian, G. Chad Hughes, J. Kevin Harrison, John V. Conte, Mubashir Mumtaz, Jae K. Oh, Jian Huang, David H. Adams and for the CoreValve U.S. Pivotal High Risk Trial Clinical Investigators
Abstract
Background The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality–risk patients.
Objectives The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability.
Methods Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned.
Results A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years.
Conclusions This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)
Prosthesis-patient mismatch (PPM) after surgical aortic valve replacement (AVR) for aortic stenosis is generally associated with worse outcomes. Transcatheter AVR (TAVR) can achieve a larger valve orifice and the effects of PPM after TAVR are less well studied.
OBJECTIVES:
The authors utilized the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) registry to examine the frequency, predictors, and association with outcomes of PPM after TAVR in 62,125 patients enrolled between 2014 and 2017.
METHODS:
On the basis of the discharge echocardiographic effective valve area indexed to body surface area, PPM was classified as severe (<0.65 cm2/m2), moderate (0.65 to 0.85 cm2/m2), or none (>0.85 cm2/m2). Multivariable regression models were utilized to examine predictors of severe PPM as well as adjusted outcomes, including mortality, heart failure (HF) rehospitalization, stroke, and quality of life, at 1 year in 37,470 Medicare patients with claims linkage.
RESULTS:
Severe and moderate PPM were present following TAVR in 12% and 25% of patients, respectively. Predictors of severe PPM included small (≤23-mm diameter) valve prosthesis, valve-in-valve procedure, larger body surface area, female sex, younger age, non-white/Hispanic race, lower ejection fraction, atrial fibrillation, and severe mitral or tricuspid regurgitation.
At 1 year, mortality was 17.2%, 15.6%, and 15.9% in severe, moderate, and no PPM patients, respectively (p = 0.02).
HF rehospitalization had occurred in 14.7%, 12.8%, and 11.9% of patients with severe, moderate, and no PPM, respectively (p < 0.0001).
There was no association of severe PPM with stroke or quality of life score at 1 year.
CONCLUSIONS:
Severe PPM after TAVR was present in 12% of patients and was associated with higher mortality and HF rehospitalization at 1 year. Further investigation is warranted into the prevention of severe PPM in patients undergoing TAVR.
We reviewed currently available studies that investigated prosthesis-patient mismatch (PPM) in transcatheter aortic valve implantation (TAVI) with a systematic literature search and meta-analytic estimates.
METHODS:
To identify all studies that investigated PPM in TAVI, MEDLINE and EMBASE were searched through August 2015. Studies considered for inclusion met the following criteria: the study population included patients undergoing TAVI and outcomes included at least post-procedural PPM prevalence. We performed three quantitative meta-analyses about (1) PPM prevalence after TAVI, (2) PPM prevalence after TAVI versus surgical aortic valve replacement (SAVR), and (3) late all-cause mortality after TAVI in patients with PPM versus patients without PPM.
RESULTS:
We identified 21 eligible studies that included data on a total of 4,000 patients undergoing TAVI. The first meta-analyses found moderate PPM prevalence of 26.7%, severe PPM prevalence of 8.0%, and overall PPM prevalence of 35.1%. The second meta-analyses of six studies, including 745 patients, found statistically significant reductions in moderate (p = 0.03), severe (p = 0.0003), and overall (p = 0.02) PPM prevalence after TAVI relative to SAVR. The third meta-analyses of five studies, including 2,654 patients, found no statistically significant differences in late mortality between patients with severe PPM and patients without PPM (p = 0.44) and between patients with overall PPM and patients without PPM (p = 0.97).
CONCLUSIONS:
Overall, moderate, and severe PPM prevalence after TAVI was 35%, 27%, and 8%, respectively, which may be less than that after SAVR. In contrast to PPM after SAVR, PPM after TAVI may not impair late survival.
Other related studies published on TAVR, TAVI in this Open Access Online Scientific Journal include the following:
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
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
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
Rhythm Management Device Hardware (Dual-chamber Pacemaker) coupled with BackBeat’s Cardiac Neuromodulation Therapy (CNT) bioelectronic therapy for Lowering Systolic Blood Pressure for patients with Pacemakers
Reporter: Aviva Lev-Ari, PhD, RN
BackBeat’s CNT is a bioelectronic therapy that immediately, substantially and chronically lowers blood pressure (BP) while simultaneously modulating the autonomic nervous system (ANS). Mimicking the effects of multiple medications by reducing pre-load, after-load and sympathetic tone, it can be delivered using standard rhythm management device hardware such as dual-chamber pacemakers.
October 2, 2018 — Two-year results of the Moderato I Study demonstrated immediate, substantial and sustained reduction in blood pressure when BackBeat cardiac neuromodulation therapy (CNT) was used in patients with persistent hypertension (office BP > 150mmHg). Patients in the study had persistent hypertension despite two or more anti-hypertensive medications and an indication for a pacemaker.
Results of the multicenter clinical trial were presented at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) conference, Sept. 21-25 in San Diego, by Daniel Burkhoff, M.D., Ph.D., director, heart failure, hemodynamics and mechanical circulatory support research for the Cardiovascular Research Foundation (CRF).
“The clinical efficacy and safety data observed with BackBeat CNT in a patient population with a significant portion of isolated systolic disease is very promising. Hypertension affects over 70 percent of pacemaker patients. These patients could benefit substantially from a potent hypertension therapy such as BackBeat CNT that could be included in their already necessary pacemaker,” said Prof. Petr Neuzil, M.D., head of the Department of Cardiology of Na Homolce Hospital in Prague, Czech Republic and one of the principal investigators of the study.
The 27 patients that met the study inclusion criteria were implanted with BackBeat’s proprietary Moderato dual-chamber pacemaker that incorporates the BackBeat CNT algorithms. The primary safety and efficacy endpoint results of the study were as follows:
Efficacy Outcomes: Immediate, substantial and sustained reduction in blood pressure.
14.2 mmHg decrease from baseline (p<0.001) in 24 hours ambulatory systolic blood pressure (AMB BP) at 3 months
23.4 mmHg decrease from baseline (p < 0.001) in systolic blood pressure (SBP) sustained out to 2 years
High responder rate in a population where 78 percent of patients had isolated systolic hypertension.
85 percent AMB BP reduced >5mmHg
74 percent AMB BP reduced >10 mmHg
Safety Outcomes: The study met the safety endpoint.
Observed reduction in end systolic and diastolic volumes with no change to ejection fraction suggests improvement of cardiac function
Observed reduction in heart rate out to 2 years indicative of reduced sympathetic activity
“These statistically significant results demonstrate the potential for BackBeat CNT to be a broadly applicable therapy that substantially lowers blood pressure immediately and maintains reduced pressures for years,” commented Burkhoff. “It is rare to see a new therapy show such dramatic and sustained effects in such a small number of patients.”
To further investigate the efficacy and safety of BackBeat CNT for the treatment of hypertension, Orchestra BioMed is enrolling patients into a prospective, 1:1 randomized double-blind active treatment (BackBeat CNT) versus standard medical therapy trial, Moderato II. The study will enroll patients with uncontrolled blood pressure (office systolic > 140, day and AMB BP > 130 mmHg) treated with at least one anti-hypertension medication that are indicated for a dual-chamber pacemaker. The primary efficacy endpoint of the first cohort of the study is the comparison of the mean reduction in 24-hour systolic ambulatory blood pressure following 6 months of therapy between the treatment and the control. Primary safety endpoint is the rate of major adverse cardiac event (MACE) at 6 months between the treatment and control. The company is expecting results on the first cohort of patients in 2019.
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.
Are TAVR volume requirements limiting rural and minority access to this life-saving procedure, or are they still necessary for patient safety?
Reporter: Aviva Lev-Ari, PhD, RN
CMS Considers Changing TAVR Volume Requirements
Debate over transcatheter aortic valve replacement (TAVR) procedures continues as the Centers for Medicare and Medicaid Services (CMS) considers changing the status quo. Are TAVR volume requirements limiting rural and minority access to this life-saving procedure, or are they still necessary for patient safety?
In June 2018, cardiology news sources widely reported that CMS opened public comment on established volume requirements for hospitals and heart teams to perform TAVR. The Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) then met on July 25 to discuss the issue. A report in Cardiovascular Business suggested that the committee appeared split on the subject—especially in weighing the potential harms of limiting TAVR to only high volume hospitals.
The Case for TAVR Volume Requirements
For those on the side of maintaining TAVR volume requirements, the benefits are obvious—volume is associated with positive outcomes and lower rates of complications. In fact, a 2018 expert consensus document from four major cardiology societies actually supported increasing volume requirements to maintain a TAVR program, to ensure adequate data collection for statistically reliable quality metrics and quality assurance.
A new study published in September in JACC: Cardiovascular Interventions seems to add new weight to this argument—data collected from hospitals participating in the international TAVR registry showed volume to have a significant effect on patient safety. The findings suggested that a learning curve of at least 225 procedures was required for hospitals to perform TAVRs with the lowest mortality rates, and that low annual volume hospitals were associated with decreased procedural safety and higher patient mortality.
John D. Carroll, MD, of the University of Colorado School of Medicine wrote an editorial in the same publication arguing that there is a “danger of lowering TAVR quality of care” by relaxing or eliminating TAVR volume requirements. “This would create many new centers starting a new learning curve, result in more low-volume centers, and potentially diluting the case volume and advanced skills of established and high-volume centers,” he writes.
The Case Against TAVR Volume Requirements
While the case for TAVR volume requirements is strong, it does little to answer the central question of the opposing viewpoint—does the benefit of expanding TAVR access to rural areas outweigh the cost of allowing the procedure to be conducted in relatively inexperienced or low-volume centers?
It is difficult to capture data depicting how many patients with aortic stenosis go without valve replacement due to TAVR volume requirements, but the concern seems genuine. We continue to learn more about TAVR, but experts have already established the procedure as the “treatment of choice in the extreme-risk patient who cannot have surgery,” said Martin B. Leon, MD, FACC at a 2017 American College of Cardiology conference.
In this population, where surgical valve replacement is not an option, median life expectancy is increased from 11 months to almost 30 months with TAVR, according to Leon. Indeed, some experts like Deepak L. Bhatt, MD, MPH, FACC, believe that, regardless of surgical risk scores, patients over 80 should undergo TAVR rather than surgical valve replacements.
If TAVR volume requirements limit access to the procedure for this growing elderly population, the negative effects would be obvious. An Edwards Lifesciences resource about aortic stenosis states, “After the onset of symptoms, patients with severe aortic stenosis have a survival rate as low as 50% at 2 years.”
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Annuloplasty Ring
Tissue Valve
Mechanical Valve
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