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ePaper - CCN Ausgabe - Number 2/2012

Ausgabe 2 - Number 2 · 2012 CCNCCNCCNCCNCCNCCNCCNCCNCCNCCNCCNCCNCCCathlab &athlab &athlab & CCCardiovascularardiovascularardiovascularardiovascularardiovascularardiovascular NNNewsewsews PRODUCT NEWS Approve SapienTAVR for high-risk operable patients, FDA advisors say JUN 14, 2012 Shelley Wood Gaithersburg, MD (updated) - A panel of expert advisors to the US Food and Drug Administration (FDA) emphatically agrees: approved uses for the Sapien transcatheter valve (Edwards Lifesciences) should include highrisk aortic-stenosis patients who are also eligible for surgery. In the three-part vote, the panel voted 12:0 that the device was effec- tive and 10:2 that the device is safe anddelivered 11 votes in favor of the statement that its benefits outweighed any risks (one panel member, Dr John C Somberg [Rush University Medical Center, Lake Bluff, IL], abstained on this question). Approval of this indication would also usher in the company‘s transa- pical delivery system, allowing the device to bedeployed in patients whose femoral artery is not suited to transcatheter delivery of the percutaneous valve. Dr Valluvan Jeevanandam (University of Chicago, IL) and Somberg were the only panel members who voted „no“on the safety question. „I think this is a very good technology, and it gives us an alternative to AVR surgery, and I‘msure the device will continue to get better,“ Jeevanandam, a cardiovascular surgeon, told heartwire after the meeting. „However, at the current time, compared with standard AVR, this device has a higher stroke rate and ahigh rate of aortic insuffici- ency, did not meet the criteria for noninferiority in males, and has a high incidence ofvascular complications.“ These are all issues that need to be very clearly explained to patients as part of the informed-consent process, hestressed. Otherwise, pati- ents who are „enamored at the idea of avoiding a sternotomy“ may not fully understandthese risks. Grounds for expanding the indications for transcatheter aortic-valve replacement (TAVR) with the Sapien devicecome from the PARTNER A trial, as reported by heartwire. In the study, one-year mortality was similar between thesurgery and TAVR groups at 26.8% and 24.2%, respectively, meeting the predefined margin for noninferiority for- TAVR. Throughout the day, the Circulatory System Devices Panel raised concerns over crossover data and how events wereassigned to the different treatments, as well as the challenges of interpreting nonran- domized continued-accesspatients treated after the PARTNER study closed. Panel members also mulled the higher mortality rate among- patients treated via the transapical route, as compared to those treated via transfemoral delivery or by conventionalopen surgical replacement. Other trial conduct issues also spent some time in the spotlight, including stroke risk; delays to treatment amongpatients randomized to surgical aortic-valve replacement (AVR); the importance of aortic insufficiency (seen inalmost 60% of TAVR patients at one year) to long-term outcomes; and the curious discrepancy between men and- women in the trial-women had better survival at one year than men. Also speaking with heartwire, Dr David Kandzari (Piedmont Heart Institute, Atlanta, GA) said he felt the panelmembers, who often seemed reluctant to tuck into the feast of questions put to them by the FDA, missed anopportunity. „The panel fell short, I think, of providing answers to some of the gaps in our understanding, particularly issues ofgender differences, the link between aortic regurgitation and mortality, the link between atrial fibrillation and aorticregurgitation and stroke, and the potential for reducing vascular complications,“ he said. „I expected today to be abit more contentious. . . . If anything, I thought last year‘s panel meeting, for the cohort B data, actually had aclearer path to appro- val and that today‘s meeting would be less predictable. In this case, an alternative exists—surgery—and this trial did not demonstrate superiority. I think that left the door open for more debate than ween- ded up seeing today.“ Even before the voting questions, panel members seemed to have made up their minds, offering only lacklusterfeedback to the FDA‘s questions on labeling, data gaps, and indications for use. That meant a long day ofdiscussions was put to bed swiftly with paper-ballot voting (ironically, the high-tech digital voting system failed inthe final hour) and a resounding thumbs-up for the FDA. „I am delighted to see the approval process move forward,“ panel member Dr Magnus Ohman (Duke University Medical Center, Dur- ham, NC) told heartwire. „This is good news for patients with [aortic stenosis], but as wasobserved today, we still have a lot to learn. It is my hope that the excellent path that has been started on today withthe ‚heart teams‘ will continue to build so we can foster better collaboration with [cardiothoracic] surgery in thefuture.“ Dr Warren Laskey (University of New Mexico School of Medici- ne, Albuquerque), an interventional cardiologist,chaired today‘s 13-member panel, which also included an additional five interventio- nal cardiologists, threecardiovascular surgeons, and one neurologist. Co-primary investigators for PARTNER, Drs Craig Smith and Martin Leon (Columbia University, New York, NY), presented on behalf of the sponsor. In a surprise appearance, a third Columbia physician, Dr Jeffrey Moses, stepped up during the open public hearing to disclose that his own father,who refused to undergo AVR surgery, had undergone a TAVR procedure. The FDA is not required to follow the advice of its advisory panel but is widely expected to do so following today‘svote. The Sapien valve is already approved in two different sizes, along with a transfemoral delivery catheter, foruse in patients deemed inoperable by a multi- disciplinary team. The expanded indication sought by the sponsorw- ould extend this to patients who face a >15% risk of mortality from surgical AVR. The valves and delivery systems have been approved in Europe for several years where they are used in bothoperable and inoperable patients; fear of „indication creep,“ wherein the device is used incre- asingly in less sickpatients who do well with proven surgery, is a key reason why the FDA is scrutinizing this expanded indication socare- fully. FDA flags strokes, trial conduct, as TAVI maker seeks expanded role for Sapien [Interventional/Surgery > Interventional/Surgery; Jun 11, 2012] Next-generation transcatheter aortic valve looks good in 30-day registry data [Interventional/Surgery > Interventional/Surgery; May 18, 2012] Strokes down in new TAVI analyses [Brain/Kidney/Peripheral > Brain/Kidney/Peripheral; May 18, 2012] Some valve patients are too sick for TAVI or surgery [Interventional/Surgery > Interventional/Surgery; May 02, 2012] CMS restricts TAVI coverage to experienced operators [Interventional/Surgery > Interventional/Surgery; May 01, 2012] TAVI registry updates ADVANCE the field, raise hopes for lower stroke rates [Interventional/Surgery > Interventional/Surgery; Mar 24, 2012] AF following TAVI associated with higher risk of stroke [Arrhythmia/EP > Arrhythmia/EP; Dec 14, 2011] Improving patient selection for TAVI: A work in progress [Interventional/Surgery > Interventional/Surgery; Oct 27, 2011] Similar survival, different risks for TAVI vs surgery: PARTNER A published [Interventional/Surgery > Interventional/Surgery; Jun 05, 2011] 47