Annals Thoracic Surgery, Author Interviews, Heart Disease, Surgical Research / 07.06.2016
Transfemoral TAVI More Beneficial than Surgery For Some With Aortic Stenosis
MedicalResearch.com Interview with:
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Dr. Giovanni Esposito[/caption]
Giovanni Esposito MD, PhD
Associate Professor of Cardiology
Department of Advanced Biomedical Sciences
Federico II University, Naples
Napoli - Italy and
Giuseppe Gargiulo, MD
PhD Student
Federico II University of Naples, Italy
MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Esposito: Aortic stenosis (AS) is the most frequent type of valvular heart disease in Europe and North America. As soon as symptoms occur, the prognosis of severe AS is poor, with majority of patients dying within 2 to 5 years. Unfortunately medical therapy of AS has no significant effects on patient survival, therefore the only treatment able to improve patient prognosis is valve replacement. Until 2002, the only treatment strategy was the surgical aortic valve replacement (SAVR). SAVR requires an open-heart procedure and cannot be offered to all patients with AS due to their advanced age and presence of comorbidities that make them inoperable or at high-risk for surgery. In the last decade, the less invasive percutaneous approach called transcatheter aortic valve implantation (TAVI) has demonstrated to be a valid alternative to SAVR for those patients deemed inoperable or at high risk for SAVR. After the first percutaneous intervention performed by Alain Cribier in 2002, TAVI has rapidly accumulated growing interest and enthusiasm that led to the first PARTNER trial guiding current guideline recommendations. Both American and European guidelines recommend to perform TAVI in all patients judged inoperable, and to consider TAVI as an alternative in high-risk patients, but with a Class IIb and a preference to SAVR. However, scientific evidence on TAVI exploded in the last few years, the guidelines cited are outdated (2014 and 2012 respectively), we have today 5 randomized trials and many other observational studies including patients with different pre-procedural risk (i.e lo-to-intermediate and high-risk), as well as long-term results of prior studies (i.e. 5-year follow-up of the PARTNER trial and 3-year of the US CoreValve trial), therefore we conducted a systematic review and meta-analysis comparing clinical outcomes, including short- and mid-term mortality, of adult patients with severe aortic stenosis undergoing either TAVI or SAVR with the aim to update this comparison and offer new perspectives.
Dr. Giovanni Esposito[/caption]
Giovanni Esposito MD, PhD
Associate Professor of Cardiology
Department of Advanced Biomedical Sciences
Federico II University, Naples
Napoli - Italy and
Giuseppe Gargiulo, MD
PhD Student
Federico II University of Naples, ItalyMedicalResearch.com: What is the background for this study? What are the main findings? Dr. Esposito: Aortic stenosis (AS) is the most frequent type of valvular heart disease in Europe and North America. As soon as symptoms occur, the prognosis of severe AS is poor, with majority of patients dying within 2 to 5 years. Unfortunately medical therapy of AS has no significant effects on patient survival, therefore the only treatment able to improve patient prognosis is valve replacement. Until 2002, the only treatment strategy was the surgical aortic valve replacement (SAVR). SAVR requires an open-heart procedure and cannot be offered to all patients with AS due to their advanced age and presence of comorbidities that make them inoperable or at high-risk for surgery. In the last decade, the less invasive percutaneous approach called transcatheter aortic valve implantation (TAVI) has demonstrated to be a valid alternative to SAVR for those patients deemed inoperable or at high risk for SAVR. After the first percutaneous intervention performed by Alain Cribier in 2002, TAVI has rapidly accumulated growing interest and enthusiasm that led to the first PARTNER trial guiding current guideline recommendations. Both American and European guidelines recommend to perform TAVI in all patients judged inoperable, and to consider TAVI as an alternative in high-risk patients, but with a Class IIb and a preference to SAVR. However, scientific evidence on TAVI exploded in the last few years, the guidelines cited are outdated (2014 and 2012 respectively), we have today 5 randomized trials and many other observational studies including patients with different pre-procedural risk (i.e lo-to-intermediate and high-risk), as well as long-term results of prior studies (i.e. 5-year follow-up of the PARTNER trial and 3-year of the US CoreValve trial), therefore we conducted a systematic review and meta-analysis comparing clinical outcomes, including short- and mid-term mortality, of adult patients with severe aortic stenosis undergoing either TAVI or SAVR with the aim to update this comparison and offer new perspectives.
Dr. Jeffrey Schussler[/caption]
Jeffrey M. Schussler, MD, FACC, FSCAI, FSCCT, FACP
Baylor Scott & White Health Care System
Cardiology: Baylor University Medical Center, Dallas, Tx
Medical Director: CVICU Hamilton Heart and Vascular Hospital
Professor of Medicine: Texas A&M School of Medicine
MedicalResearch.com: What is the background for this study?
Dr. Schussler: For the past few years, there has been an increased interest in performing coronary catheterization through the wrist. This is a technique that has been done (with great success and low complication rate) in other countries for years, with adoption rates >90% in some places. The US has been slower to adopt performing catheterization from the wrist, but the rate of using this approach has grown tremendously in the last 5 years. While less than 5% of all interventions were done using radial access previously, it now appraches 30% nationally. This increased rate of adoption been spurred on by studies which have shown lower incidences of complications, as well as some mortality benefit, and in particular in those patients who are highest risk for complications.
Dr. Sarmad Sadeghi[/caption]
Sarmad Sadeghi MD, MS, PhD
Assistant Professor of Medicine
Norris Comprehensive Cancer Center
University of Southern California
MedicalResearch.com: What is the background for this study?
Dr. Sadeghi: Several years ago analyses of outcomes for radical prostatectomy highlighted the significant impact of surgical experience on the oncological outcome for the patients. In this case experience was measured by the number of radical prostatectomies performed by the surgeon, and oncological outcome was measured by treatment failure rates (rising PSA). Despite this data, the move for redirecting patients to “high volume centers” where more experienced surgeons perform the operation has been sluggish. There was insufficient data on what is involved in referring patients to high volume centers and whether or not such action is cost effective.
In a previous study we demonstrated that for every referral to a high volume center, there would be an average of $1,800 over a follow-up period of 20 years in societal cost savings. The main source of these savings is fewer treatment failures.
The next question was who is a good candidate for referral and whether these savings can offset the referral costs.
Dr. Mary Forhan[/caption]
Dr. Mary Forhan OT Reg (Alberta), PhD, Assistant Professor ad
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Dr-Tasuku-Terada[/caption]
Dr. Tasuku Terada, post-doctoral research fellow
Faculty of Rehabilitation Medicine
University of Alberta
MedicalResearch.com: What is the background for this study?
Response: The prevalence of obesity has increased. Notably, a proportion of severe obesity (body mass index: body weight [kg] divided by height squared [m2]: >40kg/m2) has shown the most significant increase. Greater body mass increases the risk of cardiovascular disease and referrals for coronary artery graft surgery (CABG) have increased in patients with severe obesity. Interestingly, while obesity is often considered to increase the risk of complications and associated health care costs, many studies have reported better prognosis in patients with obesity compared to patients with normal weight, a phenomenon referred to as the obesity paradox. Therefore, it was not clear if patients with severe obesity were at higher risk of complications and contributed to greater resource use. A better understanding of the relationship between obesity and post-surgical adverse outcomes was needed to provide quality and efficient care.
Dr. Nombela Franco[/caption]
Luis Nombela-Franco, MD, PhD
Structural cardiology program.
Interventional Cardiology department.
Hospital Clínico San Carlos, Cardiovascular Institute
Madrid, Spain
(Dr. Nombela-Franco, has a special interest in interest on percutaneous treatment of structural heart disease and coronary interventions with special focus on chronic total occlusion)
MedicalResearch.com: What is the background for this study?
Dr. Nombela-Franco: In-hospital infections are one of the most common complications that may occur following medical and surgical admissions, significantly impacted length of hospital stay, costs and clinical outcomes. In addition, approximately one third of hospital-acquired infections are preventable.
Transcatheter aortic valve replacement (TAVR) is currently the standard of care for symptomatic patients with severe aortic stenosis deemed at high surgical risk or inoperable. Patients undergoing TAVR have several comorbidities and the invasive (although less invasive the surgical treatment) nature of the procedure and peri-operative care confers a high likelihood in-hospital infections in such patients. This study analyzed the incidence, predictive factors and impact of in-hospital infections in patients undergoing transcatheter aortic valve implantation.
Dr. Mark Cohen[/caption]
Mark E. Cohen, PhD
Statistical Manager
Continuous Quality Improvement
Division of Research and Optimal Patient Care
American College of Surgeons
Chicago, IL
MedicalResearch.com: What is the background for this study?
Dr. Cohen: The ACS NSQIP Surgical Risk Calculator (built from 2.7 million patient records from nearly 600 hospitals) has been widely adopted as a decision aid and informed consent tool by surgeons and patients. Predictive accuracy can be assessed in terms of discrimination, calibration, and combined discrimination and calibration. In this study, we focused primarily on calibration. Calibration refers to the consistency of agreement between observed and predicted risk across the range of predicted risk. One would not want, for example, a model that dramatically overestimates risk for low-risk patients and underestimates risk for high-risk patients – this sort of systematic error, if of sufficient magnitude, would make a risk calculator unacceptable for clinical use. We also assessed the potential benefits of statistical recalibration using restricted cubic splines.
MedicalResearch.com: What are the main findings?
Dr. Cohen: Without recalibration, the Risk Calculator was shown to have excellent calibration, though there was, at times, a slight tendency for predicted risk to be overestimated for lowest- and highest-risk patients and underestimated for moderate-risk patients. After recalibration this distortion was eliminated.
Dr. Atul Sharma[/caption]
Atul Sharma MD, MSc(Statistics), FRCPC
Researcher, Children’s Hospital Research Institute of Manitoba; Assistant Professor, Department of Pediatrics and Child Health, University of Manitoba; Senior Consultant, Biostatistics Group, George and Fay Yee Center for Healthcare Innovation
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Sharma: Between 1978 and 2004, a previous comparison of directly measured heights and weights demonstrated an alarming increase in the prevalence of overweight or obesity in Canadian children aged 2-17y, from 23.3% (95% CI = 20.5-26.0) to 34.7% (33.0-36.4) based on the new 2007 WHO criteria.
In Canada, the definitions of overweight and obesity changed with the introduction of the new '2010 WHO Growth Charts for Canada’, Previous definitions were based on Body Mass Index (BMI) percentiles from the 2000 Centers for Disease Control and Prevention (CDC) growth chart’s. In addition to revising the percentile thresholds for diagnosing overweight or obesity, the WHO charts were based on a very different reference population. As a result, the proportion of Canadian children being classified as overweight or obese increased with the introduction of the new WHO charts.
Our current study applied current Canadian definitions of overweight and obesity to a contemporary sample of Canadian children age 3-19y to assess recent trends in the rates of overweight and obesity. By pooling data from the Canadian Community Health Survey (CCHS, cycle 2.2) and the Canadian Health Measures Survey (CHMS, cycles 2 and 3), we were able to study a representative sample of more than 14000 Canadian children from the period 2004-2013. The sample was evenly split between boys and girls and approximately 80% white.
Dr. Josefin Segelman[/caption]
Josefin Segelman MD, PhD
Senior consultant colorectal surgeon
Department of Molecular Medicine and Surgery
Karolinska Institutet
Ersta Hospital
Stockholm Sweden
MedicalResearch.com: What is the background for this study?
Dr. Segelman: Hormonal factors influence the development of colorectal cancer. Observational studies and clinical trials have reported a protective effect of hormone replacement therapy and oral contraceptives. Oophorectomy alters endogenous levels of sex hormones, but the effect on colorectal cancer risk is unclear. Removal of the ovaries alters levels of sex hormones in both pre- and postmenopausal women. In premenopausal women, bilateral oophorectomy is followed by surgical menopause as the endogenous estrogen levels drop. Both before and after natural menopause, bilateral oophorectomy promptly decreases endogenous androgen levels by half as the ovaries and adrenals are equally important for androgen production.
MedicalResearch.com: What are the main findings?
Dr. Segelman: The present nationwide cohort study explored the association between removal of the ovaries for benign indications and subsequent risk of colorectal cancer. Among 195 973 women who underwent the procedure from 1965 – 2011, there was a 30% increased risk of colorectal cancer compared with the general population. After adjustment for various factors, women who underwent bilateral oophorectomy had a higher risk of rectal cancer than those who had unilateral oophorectomy (HR 2.28, 95% CI 1.33-3.91).
Dr. Alison Fecher[/caption]
Alison M. Fecher, MD
Assistant Professor of Surgery
Indiana University Health
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Fecher: It has long been known that female faculty are underrepresented in departments of surgery at U.S. medical schools. Our study wanted to identify obstacles women face in entering certain surgical subspecialties and in career advancement. We found that women are poorly represented in some of the most competitive subspecialties, including cardiothoracic and transplant surgery. We also found that women tend to advance more slowly up the career ladder, with many of them spending more years at the assistant professor level than their male counterparts. One reason for this may be that they tend to publish less peer-reviewed articles than male faculty; however, our results show that the publications of female faculty often has a greater impact on the field, as measured by citations and recentness of articles.

Dr. Asal Mohamadi Johnson[/caption]
Asal Mohamadi Johnson, PhD, MPH
Assistant Professor of Epidemiology, Integrative Health Science
Stetson University
DeLand, FL 32723
MedicalResearch.com: What is the background for this study?
Dr. Johnson: Public health research is primarily focused on neighborhood poverty and racial disparities by illustrating differences between white and black individuals or communities. For example, it has been established that African Americans have higher cancer mortality rates and are less likely to receive appropriate treatment that whites. What we wanted to know in this study was the impact of living in segregated areas apart from other area level characteristics such as poverty or education. Instead of solely looking at health disparities between whites and black patients, our study focused on differences in survival among black patients with early stage Non-Small Cell Lung Cancer (NSCLC) living in different levels of neighborhood segregation.













