TAVR Linked To Improved Quality of Life Even After Two Years

MedicalResearch.com Interview with:

Suzanne J. Baron, MD, MSc Saint Luke’s Mid America Heart Institute School of Medicine University of Missouri, Kansas City

Dr. Baron

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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How Do Patients With Compromised Kidney Function Do After TAVR?

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

Dr. Beohar

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.

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TAVR for Bicuspid Vs. Tricuspid Aortic Valve Stenosis

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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Requiring Pacemaker Within 30 Days of TAVR Linked To Worse Prognosis

MedicalResearch.com Interview with:
Opeyemi O. Fadahunsi, MBBS, MPH
Department of Medicine
Reading 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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TAVR: Women Have More Short Term Complications But Better One-Year Survival

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

Dr. Michael Gaglia

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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Patients With a Normal EKG after TAVI Rarely Require a New Pacemaker

MedicalResearch.com Interview with:
Dr. Stefan Toggweiler, MD
Heart Center, Luzerner Kantonsspital
Lucerne, Switzerland

MedicalResearch.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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Atrial Fibrillation Increases Risk of Stroke After TAVR

Prof. Johan Bosmans Interventional cardiologist University Hospital Antwerp, Wilrijkstraat 10, 2650, Edegem, BelgiumMedical 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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Transcatheter Heart Valves Linked To Less Blood Breakdown

Josep Rodés-Cabau MD Quebec Heart and Lung Institute, Quebec City, QC, CanadaMedicalResearch.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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TAVR Bests Standard Therapy For Sick, Elderly Patients With Severe AS

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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Success of TAVR for Failed Aortic Prosthetic Valves

Dr. Danny Dvir MD St Paul’s Hospital, Vancouver British Columbia, CanadaMedicalResearch.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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