TAVR Study Will Examine Benefits of Non-Femoral Access

STSNews THE SOCIETY OF THORACIC SURGEONS Vol. 18, Issue 3 Summer 2013 “Alternative Access” TAVR Study Will Examine New Guidelines Benefits of Non-Femoral Access on Aortic Valve Disease Now Online STS has launched an investigational study with STS has released clinical the American College of practice guidelines to address Cardiology that may allow major advances in the evaluation more patients to benefit from and management of patients transcatheter aortic valve with aortic valve disease. An executive summary of the replacement (TAVR). guidelines was published in the April issue of The Annals of TAVR using the Edwards Thoracic Surgery, while the full SAPIEN valve was recently guidelines were published as a approved in the United States supplement to the June issue. for inoperable or high-risk “For cardiac surgeons and patients with aortic stenosis. cardiologists, there have been For most patients, the few options and no guidelines transfemoral approach is used, on how to manage high-risk, but some patients have too previously inoperable patients,” much disease in the femoral said Lars G. Svensson, MD, artery to permit using PhD, Chair of the Guideline this approach. Task Force. “In creating these new guidelines, we wanted to The new study will evaluate outline the pros and cons of the safety and efficacy of treatment options for repairing the aortic valve, replacing the “alternative access” approaches The transapical approach to TAVR, as shown here, is one of the valve, and using transcatheter for TAVR, including transapical, “alternative access” methods being studied for safety and efficacy. approaches. We also wanted transaortic, transsubclavian/ to outline areas where more investigational device exemption (IDE) to study transaxillary, and transiliac. research is needed and the alternative access approaches using the STS/ incorporate quality metrics.” ™ “An estimated 1 in 4 patients has been ACC TVT Registry , which is a device surveillance ineligible for TAVR because advanced disease and benchmarking tool the two organizations The new aortic valve and ascending aorta clinical precludes use of the FDA-approved access site,” said developed to track clinical outcomes and improve practice guidelines make STS Research Center Director Fred Edwards, MD, patient safety. The IDE is believed to be the first recommendations in 26 areas, sponsored by any medical specialty society. Emeritus Professor of Surgery at the University including mechanical aortic of Florida, Jacksonville, and one of the study’s valves, biological valves, and principal investigators. “This trial will determine The study will use TVT Registry data pertaining to transcatheter aortic valve whether ‘alternative access’ procedures are as safe inoperable patients aged 18 years and older who replacement. You can and effective as procedures using the presently undergo TAVR for severe aortic stenosis using any access these and several other approved approaches.” non-femoral access approach with an Edwards STS clinical practice guidelines SAPIEN valve between now and December 31, 2018. at www.sts.org/guidelines. Earlier this year, the US Food and Drug Administration granted STS and the ACC a unique continued on page 6 PRESIDENT’S COLUMN Screening for Lung Cancer: An Important Opportunity to Advocate for Our Patients Douglas E. Wood, MD, President The STS mission is “to enhance the ability of finding that benefits our patients at risk for to educate policymakers about the major cardiothoracic surgeons to provide the highest lung cancer, overshadowing improvements opportunity to save lives from our most quality patient care through education, in surgical care, new chemotherapy drugs, common cause of cancer death and shine a research, and advocacy.” We accomplish this and evolution in radiation combined. This light on the long delay in action by the USPSTF. mission in innumerable ways: leading research immediately led to a reassessment of lung through our new Research Center, enhancing cancer screening by specialty physician It is easy to understand caution on the part quality through our STS National Database, groups and patient advocates. The first, of the USPSTF. Cancer screening is not the educating surgeons during our annual meeting and probably the most comprehensive, same as treatment of a disease. Legitimate and multiple freestanding courses, collaborating new guideline supporting lung cancer potential harms of screening may outweigh with like-minded specialty societies in screening was published by the National the benefits, particularly if the population education and guidelines, and advocating Comprehensive Cancer Network (NCCN) in selected for screening is too broad, leading for health care policy that is important in October 2011. The multidisciplinary NCCN to fruitless workups, unnecessary testing, the delivery of thoracic and cardiovascular guidelines group considered not only the and perhaps even risky procedures being care. Increasingly our mission leads us into complex issue of patients at risk for lung performed on individuals at low risk for initiatives and engagement that directly impact cancer who are screening candidates, but cancer. And the USPSTF has recent experience our most important constituency, our patients. also the conduct of the screening program in the consequences of overreach in breast Last year we successfully supported a National itself and management of abnormal findings. and prostate screening programs, as well as Coverage Determination for TAVR, assuring Several US societies have already published the political backlash of trying to pull back our patients equal access to consistent high- guidelines or statements recommending from screening guidelines precedent. But quality care related to this new technology. lung cancer screening, including STS, the there are also harms of delay or too narrow This year, opportunities may arise related to American Cancer Society, the American Lung interpretation of the patient population at risk. new therapies for mitral and pulmonic valves; Association, the American College of Chest The evidence supporting lung cancer screening however, perhaps no issue has more urgency Physicians, the American Society of Clinical is compelling. The benefits far outweigh the or imperative than the emergence of lung Oncology, and the American Association for risks of screening in the NLST population, cancer screening. Herein lies the prospect Thoracic Surgery. (Read STS’s statement at meaning that delay in recommendations and for STS members, individually and as a www.sts.org/LungCancerStatement.) The coverage decisions denies the chance of cancer Society, to substantially lower lung cancer NCCN has completed its third annual update cure for some of the 160,000 people who die mortality by serving as patient advocates and of lung cancer screening guidelines, refining of lung cancer each year. Further, it is naïve facilitating access to lung cancer screening for and revising them each year as new data and narrow-minded to argue that only patients patients at risk. are published. with the NLST inclusion criteria should be eligible for screening given decades of research The National Lung Screening Trial (NLST) What is remarkable is that the primary body that have outlined additional risk factors other randomized more than 53,000 patients responsible for recommendations that direct than smoking. I believe our patients who are to screening with low-dose computed national health policy, the United States at risk of developing and dying of lung cancer tomography (LDCT) versus chest x-ray, and, Preventive Services Task Force (USPSTF), deserve thoughtful and timely access to lung in October 2010, the NLST was halted due to has yet to make any recommendations about cancer screening. This is a time when we can a 20% mortality reduction identified in the lung cancer screening, even though the NLST support and advocate for our patients. Write to study population (LDCT). A 20% mortality results were announced nearly 3 years ago. your Congressional representatives and/or HHS reduction is, by far, the most profound This is in spite of assurances from AHRQ, Secretary Kathleen Sebelius, urge action by which oversees the USPSTF, that screening the USPSTF, and do not let politics or finances recommendations would be forthcoming in interfere with clear evidence of benefit from See page 14 for more 2012. This past May, I joined other physicians lung cancer screening for our patients. information. and government officials in a Senate briefing 2 STS News Summer 2013 PRACTICE MANAGEMENT The Society’s Coding Help Desk Addresses Common mission is to Questions, Scenarios enhance the ability of cardiothoracic Every cardiothoracic surgeon wants to maximize Answer: Code 33870 is bundled into all of the his/her reimbursement within the prescribed ascending aorta graft procedures (33860 – 33864). surgeons to provide payer rules. And while the intricacies of coding For procedures that involve reimplantation of the highest quality may seem complicated, the best outcomes are the head vessels—either as an island pedicle or often achieved when the surgeon is informed and individually—the -59 modifier should be appended patient care through works in tandem with the office billers. to code 33870 to pull it out of the bundle. The edit education, research, is to ensure that 33870 is not reported for situations and advocacy. The following represent a recent sampling of where a hemi-arch repair is done and the head questions and answers from the STS

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