MedicalResearch.com Interview with:
Ashwin Nathan, MD, MSHPAssistant Professor, Medicine, Perelman School of Medicine
Interventional Cardiologist
Hospital of the University of Pennsylvania and at the
Corporal Michael C. Crescenz VA Medical Center in Philadelphia
Penn Cardiovascular Outcomes, Quality & Evaluative Research Center
MedicalResearch.com: What is the background for this study? What are the main findings?Response: We found that the rates of TAVR were lower in areas with higher proportions of Black, Hispanic and socioeconomically disadvantaged patients. Inequities in access in areas with higher proportions of Black and Hispanic patients existed despite adjusting for socioeconomic status.
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MedicalResearch.com Interview with:
Chayakrit Krittanawong, MD
Section of Cardiology
Baylor College of Medicine
Houston, TX
MedicalResearch.com: What is the background for this study? Response: Transcatheter Aortic valve Implantation (TAVI) has emerged as equally effective alternative to surgical aortic valve replacement (SAVR) to treat severe aortic stenosis (AS) in all risk groups. In particular, less is known about the heart failure (HF) patients who undergo TAVI. Whether certain subtypes of HF respond differently after TAVI remains a mystery.
In this study, we sought to assess and compare the incidence and predictors of in-hospital mortality among patients with heart failure with preserved ejection fraction (HFREF) versus heart failure with preserved ejection fraction (HFPEF).
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MedicalResearch.com Interview with:Fausto Biancari, MD, PhDProfessor
University of Turku and University
Oulu, Finland
MedicalResearch.com: What is the background for this study? Response: Current data is scarce regarding the short- and midterm benefit of transcatheter aortic valve replacement (TAVR) compared to surgical aortic valve replacement (SAVR) in low-risk patients with severe aortic valve stenosis.
MedicalResearch.com: What are the main findings?Response: In this observational study on 2841 low-risk patients with aortic valve stenosis from the Finnish nationwide FinnValve registry, propensity score matching analysis showed similar 30-day and three-year survival after TAVR and SAVR.
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MedicalResearch.com Interview with:
Rajat Kalra, MBCh
Cardiovascular Division
University of Minnesota, Minneapolis
MedicalResearch.com: What is the background for this study? Response: New-onset atrial fibrillation after aortic valve procedures is thought to occur frequently after aortic valve procedures, such as transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (AVR). However, the incidence estimates and implications of this new-onset atrial fibrillation in the contemporary era are unclear.
We sought to examine the incidence of atrial fibrillation after aortic valve procedures, compare the incidence between TAVI and AVR, and evaluate the associated morbidity and mortality implications using a ‘big data’ approach. This big data approach employed the National Inpatient Sample and was validated in the New York State Inpatient Database. Both are publicly available datasets that are developed as part of the Healthcare Cost and Utilization Project, a federal-state-industry partnership that is sponsored by the Agency for Healthcare Research and Quality.(more…)
MedicalResearch.com Interview with:
Annapoorna Kini, MD
Zena and Michael A Wiener Professor of Medicine
Director of the Cardiac Catheterization Laboratory
Mount Sinai Heart at Mount Sinai Hospital
MedicalResearch.com: What is the background for this study?
Expanding indication and use of Transcatheter aortic valve replacement (TAVR) poses a unique problem of coronary access after valve implantation.
Troubleshooting tools and techniques have been published but are not available at the fingertips of the user at all the times.
We tried to address this unique problem with an innovative educational mobile application (app) called "TAVRcathAID".
MedicalResearch.com Interview with:
JOÃO L. CAVALCANTE, MD, FASE, FACC, FSCCT, FSCMR
Director, Cardiac MRI and Structural CT Labs
Director, Cardiovascular Imaging Research Core Lab
Minneapolis Heart Institute
Abbott Northwestern Hospital
Minneapolis, MN, 55407
MIHO FUKUI MD
Division of Cardiovascular Diseases, Department of Internal Medicine, Heart & Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota
MedicalResearch.com: What is the background for this study? Response: Recent study by Généreux et al (1), using the Placement of Aortic Transcatheter Valves (PARTNER) 2A and 2B data, provided the first framework of a staging system for severe aortic stenosis (AS) that quantifies the extent of structural and functional cardiac change associated with AS and importantly its association with 1-year mortality in patients receiving either surgical or transcatheter AVR (TAVR):
Stage 0: No other cardiac damage;
Stage 1: LV damage as defined by presence of LV hypertrophy, severe LV diastolic, or LV systolic dysfunction;
Stage 2: Left atrium or mitral valve damage or dysfunction;
Stage 3: Pulmonary artery vasculature or tricuspid valve damage or dysfunction; and
MedicalResearch.com Interview with:
Dae Hyun Kim, MD, MPH, ScD
Assistant Professor of Medicine, Harvard Medical School
Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital
Division of Gerontology, Department of Medicine,
Beth Israel Deaconess Medical Center
MedicalResearch.com: What is the background for this study? What are the main findings?Response: The number of older adults undergoing aortic valve replacement is increasing. Since these patients are at high risk for complications and functional decline due to preexisting multimorbidity and frailty, the latest guideline (Otto et al. J Am Coll Cardiol 2017;69:1313–46) emphasizes shared decision-making based on patient-centered outcomes. Despite this recommendation, we witness many decision-making processes are cardio-centric—mainly informed by expected benefit in terms of cardiac-specific measures. Many patients are not adequately informed about what their daily life would be like after the procedure.
In this single-center prospective cohort study, we examined functional status trajectories via assessments of global functional status at 1, 3, 6, 9, and 12 months in 246 patients who underwent transcatheter and surgical aortic valve replacement. We identified 5 clinically meaningful functional trajectories, ranging from high baseline function-early complete recovery to low baseline function-large and persistent decline. We were able to predict most likely trajectory as well as best possible and worse possible trajectories using the preoperative frailty index. Delirium and postoperative complications were also strongly associated with undesirable functional trajectories.(more…)
MedicalResearch.com Interview with:
Taku Inohara MD, PhD
Duke Clinical Research Institute,
Duke University Medical Center,
Durham, North Carolina
Department of Cardiology
Keio University School of Medicine, Tokyo, Japan
MedicalResearch.com: What is the background for this study? What are the main findings?Response: Transcatheter aortic valve replacement (TAVR) has been increasingly used for treating patients with severe aortic stenosis.
Owing to the advancement of TAVR technology, the mortality and heart failure (HF) readmission after TAVR is decreasing over time, but 4.3% experienced readmission due to HF and 23.7% died within 1 year after TAVR. Inhibition of the renin-angiotensin system (RAS) with angiotensin-converting enzyme inhibitors (ACE-Is) or angiotensin-receptor blockers (ARBs) is known to improve clinical outcomes in patients with heart failure, but there remains unknown whether a RAS inhibitor is associated with a reduction in mortality and heart failure readmission after TAVR.
Using the STS/ACC TVT Registry, a nationwide TAVR Registry in the US, we analyzed 15896 propensity-matched patients who underwent TAVR and found that receiving a prescription for a RAS inhibitor at discharge, compared with no prescription, was associated with a reduced risk for mortality ( 12.5% vs 14.9%) and HF readmission (12.0% vs 13.8%).
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MedicalResearch.com Interview with:
Harindra C. Wijeysundera MD PhD FRCPC FCCS FAHA
Director of Research, Division of Cardiology,
Schulich Heart Centre, Sunnybrook Health Sciences Centre
Senior Scientist, Sunnybrook Research Institute (SRI)
Associate Professor, Dept. of Medicine & Institute of Health Policy, Management and Evaluation, University of Toronto
Adjunct Senior Scientist, Institute for Clinical Evaluative Sciences (ICES)
Toronto, ON, Canada
MedicalResearch.com: What is the background for this study? What are the main findings?Response: One of the most common complications post TAVR is the need for a permanent pacemaker. It is unclear if the need for a pacemaker is associated with long term adverse outcomes.
Using a population level registry of all TAVR procedures in ontario, canada, we found that pacemakers were required in ~15% of cases. Requiring a pacemaker was associated with worse long term outcomes, including death, readmission to hospital and emergency room visits. (more…)
MedicalResearch.com Interview with:
Dawn Abbott, MD, FACC, FSCAI
Associate Chief, Faculty Development and Academic Advancement
Director, Interventional Cardiology and Structural Fellowship Programs
Associate Professor of Medicine
Warren Alpert Medical School, Brown
Providence, RI 02903MedicalResearch.com: What is the background for this study? Response: Approximately 35,000 transcatheter aortic valve replacement (TAVR) procedures are now performed annually in the United States (US). TAVR is usually performed as an elective procedure in hemodynamically stable patients. Approximately 1 in 5 hospitalizations for severe aortic stenosis (AS) are emergent with acute decompensation. Balloon aortic valvuloplasty (BAV) is a therapeutic option in patients with acute decompensated AS; however, long-term survival after BAV remains poor with a high incidence of valvular re-stenosis. Data on the outcomes of urgent/emergent TAVR as a rescue therapy in patients with acute decompensated severe AS are extremely limited.
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MedicalResearch.com Interview with:
Suzanne J. Baron, MD, MSc
Saint Luke’s Mid America Heart Institute
School of Medicine
University of Missouri, Kansas City
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Transcatheter Aortic Valve Replacement (TAVR) has emerged as a viable treatment option for patients with severe aortic stenosis in patients at high and intermediate surgical risk. Prior studies have demonstrated that both TAVR and surgical AVR (SAVR) results in substantial quality of life benefit in patients at high surgical risk.
Whether these results applied to an intermediate risk population was unknown and so we performed a prospective study alongside the PARTNER 2A trial to compare both short- and long-term health status outcomes in intermediate-risk patients with AS treated with either TAVR or SAVR. The analysis included 1833 patients (950 TAVR, 833 SAVR), who were evaluated at 1 month, 1 year and 2 years post procedure. By 1 month, quality of life had improved in both the TAVR and SAVR groups, although the gain was significantly greater in patients treated with TAVR via the transfemoral approach as opposed to patients treated with SAVR or with TAVR via the transthoracic approach (i.e. direct aortic access or transapical access). At 1 and 2 years, both TAVR (via either approach) and SAVR were associated with similarly large, clinically meaningful improvements from baseline in both disease-specific and generic health status scales at 2 years.
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MedicalResearch.com Interview with:
Nirat Beohar, MD
Vice-Chief of Cardiology
Director Cardiac Catheterization Laboratory
Director Structural Heart Disease Program
Director Interventional Cardiology Fellowship program
Cardiac Catheterization Laboratory
Columbia University Division of Cardiology,
Mount Sinai Medical Center
Miami Beach, Miami, FL 33140
MedicalResearch.com: What is the background for this study?Response: Nirat Beohar MD, Director of the Cardiovascular Catheterization Laboratory and Vice-Chief of Cardiology at the Columbia University Division of Cardiology at the Mount Sinai Medical Center and co-authors report the effect of trans-catheter aortic valve replacement (TAVR) on subsequent renal function and outcomes in high-risk and inoperable patients presenting with baseline renal dysfunction (eGFR < 60 ml/min/1.73 m2). This was a sub-study of patients undergoing TAVR in the PARTNER 1 trial and continued access registry that was conducted in 25 centers in the United States and Canada.
(more…)
MedicalResearch.com Interview with: Sung-Han Yoon MD
Clinical Trials, Cardiology, Developmental Biology
Cedars-Sinai Medical Center, Los Angeles
MedicalResearch.com: What is the background for this study? What are the main findings?Response: Transcatheter aortic valve replacement (TAVR) has become the standard treatment in inoperable patients in high surgical risk patients with symptomatic severe aortic stenosis (AS). However, major randomized trials excluded congenital bicuspid AS due to its unique morphological features. The indication of TAVR is expanding into a younger population, in which the frequency of bicuspid AS is higher. Therefore, we will encounter TAVR for bicuspid AS more frequently. However, the experience of TAVR in bicuspid AS is limited to small series. Therefore, we aim to evaluate the clinical outcomes of TAVR in bicuspid AS and compare them to tricuspid AS.
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MedicalResearch.com Interview with:Opeyemi O. Fadahunsi, MBBS, MPH
Department of MedicineReading Health System
West Reading, Pennsylvania
MedicalResearch.com: What is the background for this study? What are the main findings?Response: Transcatheter aortic valve replacement (TAVR) is a minimally invasive approach to managing symptomatic severe aortic stenosis in patients who have a high surgical risk or are deemed to be inoperable. One of the most frequent complications is development of conduction abnormalities requiring permanent pacemaker placement. We compared clinical outcomes in patients requiring permanent pacemaker placement post-TAVR to those not requiring a pacemaker using a large US database called the STS/ACC TVT RegistryTM . We used real-world data of patients undergoing TAVR in the US at 229 sites between November 2011 and September 2014.
The frequency of pacemaker placement within 30 days post-TAVR was 6.7% (651 of 9,785 patients). Those who needed a pacemaker within 30 days post-TAVR had longer hospital and intensive care unit stays compared to those who did not. Furthermore, those who needed a pacemaker had a higher risk of death from any cause at one year compared to those who did not get a pacemaker.
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MedicalResearch.com Interview with:Michael A. Gaglia Jr., MD, MSc, FACC, FSCAI
Scientific Lead, Population Research
Medstar Cardiovascular Research Network
Interventional Cardiology
Medstar Heart and Vascular Institute
Washington, DC 20010
MedicalResearch.com: What is the background for this study?Response: Cardiovascular outcomes vary according to gender in a variety of disease states. For example, short-term mortality is higher among women presenting with an acute coronary syndrome in comparison to men. There is a similar trend for higher short-term mortality of women undergoing coronary artery bypass grafting, although this is in part due to a relatively higher burden of comorbidities. Female gender is also a well-established risk factor for bleeding complications after percutaneous coronary intervention.
In regards to women undergoing surgical aortic valve replacement for severe aortic stenosis (AS), however, the data is equivocal; some studies suggest higher mortality for women, whereas others suggest improved survival for women.
The emergence of transcatheter aortic valve replacement (TAVR) as the preferred therapeutic option for patients with severe AS at high or extreme risk for surgery offered another opportunity to examine gender disparities in outcomes. The evidence base for the impact of gender upon TAVR, however, is still evolving. A recent meta-analysis suggested improved long-term survival among women after TAVR. And in general, previous studies also suggest more vascular and bleeding complications in women when compared to men. The goal of this study was relatively simple: to compare outcomes between women and men undergoing TAVR at a single center.
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MedicalResearch.com Interview with: Dr. Stefan Toggweiler, MD
Heart Center, Luzerner Kantonsspital
Lucerne, SwitzerlandMedicalResearch.com: What is the background for this study?Response: Transcatheter aortic valve replacement (TAVR) is increasingly used for the treatment of aortic stenosis in inoperable and high-risk patients. It is well known that TAVR is associated with acute and delayed occurrence of conduction disorders. Namely, delayed high-degree atrioventrcular block is a feared complication. Thus, patients are usually monitored by telemetry for a few days, but there is currently no consensus on the duration of telemetry. In this study, we evaluated how the postprocedural ECG determines the need for permanent pacemaker implantation in patients undergoing TAVR.
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Medical Research Interview with:
Prof. Johan Bosmans
Interventional cardiologist
University Hospital Antwerp, Wilrijkstraat 10, 2650,
Edegem, Belgium
MedicalResearch: What is the background for this study? What are the main findings?Prof. Bosmans : Transcatheter aortic valve replacement (TAVR) has become standard of care for patients who cannot undergo surgery. With this, it is important to ensure that the risks associated with TAVR be fully understood, and if possible prevented. Even at this stage of the adoption of TAVR, large trials continue to provide information to the clinician about how to select the right patients to ensure the best possible outcomes. The ADVANCE Study is a prospective, multicenter study that evaluated the use of TAVR in 1015 patients at 44 experienced TAVR centers, which was designed to reflect routine clinical practice.
We know that the risk of serious adverse events, such as stroke or transient ischemic attack (TIA), in post-TAVR patients can vary based on the timing before and after the procedure. A patient’s baseline demographics and medical history can affect their risk of procedure-related events as well as long-term outcomes. The manipulations required crossing the aortic valve and appropriately positioning any type of TAV has been thought to be related to procedural stroke events. Therefore, we performed a multivariable analysis looking for predictors of stroke – or stroke and TIA at 3 unique time periods (periprocedural, early and late) following TAVR.
The most striking result from our analyses was that we were not able to identify any predictors of periprocedural (either during the procedure or on the day after) stroke, illustrating this very multifactorial etiology. We were able to show that being female, experiencing acute kidney injury or a major vascular complication positively predicted stroke during the early (2-30 days post procedure) time period. When we combined the outcome of stroke or TIA, we found that a history of prior atrial fibrillation (AF) was also a predictor. The only late predictor (day 31-730 post-procedure) of stroke was a history of coronary artery bypass grafting, which could reflect the patients’ risk of vascular disease.
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MedicalResearch.com Interview with:
Josep Rodés-Cabau MD
Quebec Heart and Lung Institute,
Quebec City, QC, Canada
Medical Research: What is the background for this study? What are the main findings?Dr. Rodés-Cabau: Hemolysis is the breakdown of red blood cells (RBC) in the body. There are many different causes of hemolysis, however a common cause is when RBCs traverse foreign substances, such as inserted heart valve prostheses. The biological interaction between the RBC and a foreign substance may cause RBC lysis/destruction. Furthermore, in the setting of turbulent blood flow, such as when a prosthetic heart valve is starting to leak, the degree of hemolysis could reflect the severity and duration of this leak. In the absence of valve leaks, hemolysis rates and severity may simply reflect how biocompatible a foreign/prosthetic valve is within the body. The lower the hemolysis rate and severity, the more biocompatible the valve/foreign body.
There are many different brands and generations of prosthetic heart valves that have been implanted in humans during the prior decades. The early-generation surgically implanted valves caused quite severe hemolysis requiring re-operation when possible. Modern-day surgical heart valves now have superior designs and rarely cause significant hemolysis. Nevertheless the rates of sub-clinical (or biochemical) hemolysis are around 30% for modern-day mechanical heart valves.
Nowadays, certain patients are eligible to undergo transcatheter aortic valve implantation (TAVI), a revolutionary means of valve replacement without the need for open heart surgery. However to-date, the biocompatibility of these new transcatheter heart valves has not been tested in humans in vivo. We systematically evaluated hemolysis rates and its associated factors in a large consecutive series of patients undergoing TAVI at the Quebec Heart & Lung Institute, Quebec, Canada.
We found that the rate of transcatheter heart valve hemolysis was 15%, lower than that reported for modern-day mechanical surgically implanted valves. No patient demonstrated severe hemolysis. The presence of a size mismatch between the patient and transcatheter valve (termed prosthesis patient mismatch) significantly associated with the likelihood of hemolysis. Indirect measurements of wall shear stress also associated with hemolysis rates.
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Prof Samir R Kapadia MD Director, Sones Cardiac Catheterization Laboratories
Cleveland Clinic Cleveland, OH
For patients with severe symptomatic aortic stenosis (AS) who are not candidates for surgical valve replacement, transcatheter aortic valve replacement (TAVR) offers superior benefit to standard therapy, as measured by all-cause mortality, cardiovascular mortality, repeat hospital admission and functional status. PARTNER 1B 5 year data were published simultaneously with PARTNER 1A 5 year data in 2 separate manuscripts in the Lancet (March 15 2105).
In this landmark trial, TAVR produced a 22 percent survival benefit and a 28 percent reduced risk of cardiovascular mortality, compared with standard treatment.
According to Cleveland Clinic interventional cardiologist Samir Kapadia, MD, lead author of PARTNER 1B, these findings have changed the treatment paradigm for severe Aortic Stenosis patients who can’t undergo surgical Aortic Valve Replacement.
“This trial is the first—and will probably be the only—randomized AS trial that includes a standard treatment group, since these results will make it unethical to treat severe AS patients with medical therapy alone without aortic valve replacement. ” he says.
Superior survival benefit with TAVR
PARTNER 1B is the only rigorous randomized trial of extreme-risk aortic stenosis patients that has prospectively reported the outcomes of TAVR versus standard treatment in patients for whom the estimated probability of death or serious irreversible morbidity after surgical aortic valve replacement was 50 percent or greater.
The trial enrolled 358 patients between May 11, 2007 and March 16, 2009; 179 patients were assigned to TAVR with the first-generation Sapien valve and 179 to standard therapy which includes medical therapy and balloon aortic valvuloplasty. TAVR was performed under general anesthesia with common femoral artery access. Guidance was provided by transesophagel echocardiography and fluoroscopy. The mean age of participants was 83.
The primary endpoint was all-cause survival. Secondary endpoints included cardiovascular mortality, stroke, vascular complications, major bleeding and functional status.
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MedicalResearch.com Interview with: Dr. Danny Dvir MD
St Paul’s Hospital, Vancouver
British Columbia, Canada
Medical Research: Who were the patients studied?Dr. Dvir: The VIVID registry included high-risk patients with failed aortic bioprostheses treated with valve-in-valve. These patients had many comorbidities and high risk scores for early mortality with conventional redo surgery.
Medical Research: What are the treatment options for these patients?Dr. Dvir: Patients with failed bioprosthetic valves are conventionally treated with redo surgery. Transcatheter valve-in-valve is a less-invasive approach.
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MedicalResearch.com Interview with: Sammy Elmariah, MD, MPH
Massachusetts General Hospital
Boston, MA
MedicalResearch.com: What are the main findings of the study?Dr. Elmariah: Within the randomized PARTNER I trial, we evaluated the effect of left ventricular (LV) dysfunction on clinical outcomes after transcatheter and surgical aortic valve replacement (TAVR and SAVR, respectively) and the impact of valve replacement technique on recovery of LV function. We found that LV dysfunction, defined as an LV ejection fraction < 50%, had no impact on 30-day and 1-year mortality after either TAVR or SAVR. In those with baseline LV dysfunction, marked improvement in LV ejection fraction was observed within 30-days of valve replacement in approximately half of patients, with an equivalent degree of improvement observed after TAVR and SAVR. Permanent pacemaker at study entry, low mean aortic valve gradient, and high LV ejection fraction were associated with reduced odds of LV functional recovery after valve replacement.
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MedicalResearch.com Interview with:Caroline A. Kim, MD, MS;
Beth Israel Deaconess Medical Center
Boston, MA 02215.
MedicalResearch.com: What are the main findings of the study?Dr. Kim:We conducted a systematic review of 62 studies that examined functional status and quality of life in patients who underwent transcatheter aortic valve replacement (AVR) for their symptomatic severe aortic valve stenosis. In 11,205 patients who underwent TAVR, a clinically meaningful improvement was seen in physical functional measures and disease-specific quality of life measures, whereas improvement in psychological measures or more general health measures were modest and inconsistent. Given the dismal prognosis of severe aortic stenosis treated conservatively, it was clear that transcatheter AVR improved functional status and quality of life. However, there was insufficient evidence that compares these patient-centered outcomes between transcatheter AVR and surgical AVR.
(more…)
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