Biggest cardiology stories of 2012

Biggest cardiology stories of 2012

From: www.heart.org


December 13, 2012 heartwire reporters heartwire reporters



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New York, NY - What made headlines in 2012? Everything from FREEDOM to the Riata lead recall, renal denervation to PCSK9 inhibition. heartwire reporters called up cardiologists across all cardiac subspecialties to ask them what they thought the biggest news was in their field this past year. Some also gave us their best guesses for hot-button topics in the year to come.









Acute coronary syndromes



Jean-Pierre Bassand



Jean-Pierre Bassand (University Hospital Jean-Minjoz, Besançon, France): 2012 has been a relatively quiet year for ACS, with the main trial in the field (TRILOGY ACS) showing a neutral result. But for me, the biggest message coming through, with further results coming in with new drugs such as rivaroxaban and vorapaxar showing reduced ischemic outcomes, is that we might not need aspirin anymore in ACS patients. While both rivaroxaban and vorapaxar cause increased bleeding when given on top of aspirin and clopidogrel, aspirin is probably the worst culprit here. And most cardiologists are reluctant to give three antithrombotic agents together, so there is strong feeling that the next direction we have to follow is to drop aspirin. I believe there is a great future for the new anticoagulants in ACS without aspirin. And the WOEST study, although not in ACS patents, suggested aspirin was not needed in stent patients receiving clopidogrel and an anticoagulant. I believe this is the first nail in the coffin for aspirin in ACS. My hope for 2013 is that more trials with new combinations but without aspirin are launched.





Dr Mark Petrie



Dr Mark Petrie (Glasgow Royal Infirmary, Scotland): If I were to choose one highlight this year in ACS, it would be the STEMI subgroup of RIVAL. Radial access was associated with a 2.2% reduction in death/MI or stroke and a 1.9% reduction in all-cause mortality when compared with femoral access. This should be practice changing.



For 2013, I am looking forward to the DEFER results. This trial in STEMI patients should answer the question of whether we should open up the artery only with a balloon and aspiration catheter and put a stent in later (four to 16 hours) or just put the stent in there when you open the artery.



- Sue Hughes















Atrial fibrillation



Dr Albert Waldo



Dr Albert Waldo (Case Western Reserve University): For me, the fact that guidelines are finally recognizing that aspirin is of very little use to prevent stroke in AF patients was a very important step forward this year. Relevant data have been accumulating on this for several years, and it has recently been confirmed in large registry studies. The European and Japanese guidelines have now taken aspirin out completely, and the Canadian and American College of Chest Physicians guidelines have virtually done the same. Hopefully, the ACC/AHA/HRS guidelines will follow.



My big hope for 2013 is that we might finally understand the mechanism that sustains AF. We understand what triggers AF, but we don't understand why it keeps going. Other arrhythmias, where the mechanism that sustains the arrhythmia are known, can be effectively and safely eliminated with targeted ablation, but in AF we don't have that kind of precise target. But we are getting closer—there is a lot of research going on here.



- Sue Hughes















Hypertension



Dr Michael Weber



Dr Michael Weber (State University of New York, Brooklyn): The hottest thing right now is renal-nerve denervation. It is the big story, when I go around giving lectures, and it hasn't even come to the US yet but is available on the continent [Europe] and Germany in particular. It's a little unexpected how effective it really is. What we've learned is that when you cut the renal nerve, you are cutting the signal from the kidney back to the brain and the rest of the body. That is what is bringing down the blood pressure; the kidney is in a way regulating the sympathetic nervous system and telling the brain what to do.



heartwire: And in 2013?



Weber: Renal-nerve denervation.



- Lisa Nainggolan















Heart failure



Dr Paul Hauptman



Dr Paul Hauptman (Saint Louis University School of Medicine, MO): Here are the big five, in my estimation, [although] many are not HF specific. 1) The Supreme Court decision on the Affordable Care Act and the electoral loss of Mitt Romney will have repercussions for cardiology practice that may last for many years. It remains almost shocking that we are facing so much uncertainty about the nature of the changes, the degree/severity of regulatory oversight, and the financial/reimbursement implications for cardiac care going forward. 2) As a corollary, the recent penalties against hospitals for a higher-than-expected 30-day readmission rate for heart failure is the start of a remarkable and troubling shift of responsibility to acute care hospitals and health systems. 3) The approval of the HeartWare Ventricular Assist System (HeartWare, Framingham, MA) for bridge to transplant will change the landscape for [ventricular-assist-device] VAD programs, providing more choice and competition in that space. 4) The Riata lead recall and concern over the Durata lead serve to remind cardiologists of ongoing risks associated with implants. 5) The recent free-speech-affirming decision by a US Federal Appeals Court to overturn a conviction of a drug representative caught in a sting operation aimed at off-label drug marketing was a remarkable step in reestablishing fundamental rights of companies and their employees.



- Steve Stiles















Imaging

Dr Matthew Budoff (Los Angeles Biomedical Research Institute, CA): ROMICAT II and ACRIN-PA were both published in the New England Journal of Medicine this year, demonstrating that cardiac [computed tomography] CT, when used in the emergency room, saved 50% time for patients and confirmed an earlier trial (CT STAT) that showed not only that use of CT is safe and expedites discharge [but] two of the three randomized trials of cardiac CT compared with standard of care showed significant cost savings. . . . We have already starting triaging patients from our emergency room to the CT scanner, instead of using the nuclear or treadmill algorithms that have been used for many years.





Dr Pamela Douglas



Dr Pamela Douglas (Duke University, Durham, NC): The CONFIRM [registry] continues to establish CT [angiography] as a major tool in chest-pain diagnosis. DEFACTO suggests that the "holy grail" of noninvasive [fractional flow reserve] FFR may soon be obtainable, which would dramatically shift noninvasive testing patterns and alter cath-lab referral (but this is still not ready for prime time).



[There were] no blockbuster trials in echo, but the revised echo appropriate-use criteria came out, which may also alter care.



- Reed Miller















Implantable cardiac devices



Dr Anne Curtis



Dr Anne Curtis (Buffalo General Hospital, NY): I think the BLOCK-HF study will prove to be pivotal. We presented it at AHA and just submitted it last weekend, so it won't get published until 2013. It's important because it should change the way we treat patients with AV block who need pacemakers.





Kenneth Dickstein



Kenneth Dickstein (University of Bergen Stavanger, Rogaland, Norway): Due to my interest in devices (CRTs, ICDs, CRT-Ds), I noticed an interesting twist in the focus among clinicians during 2012. The evidence is convincing for efficacy across the spectrum of heart-failure patients with left bundle branch block, but physicians increasingly find that they have to consider limited resources. The indications are clear, but unlike drugs, most eligible patients will not receive evidence-based device therapy. The potential patient population is huge. The challenge is to try to implant devices in the patient population most likely to substantially benefit, and many of these patients are managed by primary-care physicians and never evaluated. And there are major outstanding issues that complicate clinical practice. Should we implant a CRT-P [biventricular pacemakers that do not offer defibrillation] or CRT-D [defibrillating cardiac resynchronization therapy devices]? What about the vigorous elderly patients, the patients requiring upgrades, and patients with atrial fibrillation? And the role of imaging in detecting mechanical dyssynchrony needs to be defined. There is also debate concerning who should be implanting. Should it always be EP physicians, or should heart-failure docs be performing the procedure? The "boring but important" follow-up of these patients is the key to success but requires a unique multidisciplinary effort.



- Steve Stiles















Interventional cardiology



Dr George Dangas



Dr George Dangas (Mount Sinai Medical Center, New York): Definitely the results of the FREEDOM trial regarding the treatment of diabetic patients with multivessel disease, as well as the results of the FAME II trial on the importance of ischemic documentation on outcomes after PCI. Third, the IABP SHOCK II trial, which had interesting insights with regard to how we treat cardiogenic-shock patients with PCI and the role of balloon-pump support in such cases.



In 2013. the initiation of a MitraClip trial in inoperable patients will, I think, reenergize the subject of percutaneous mitral-valve repair. In addition, we will have more durability data for the transcatheter aortic-valve technique with the results of the CoreValve trial as well as results in intermediate-risk patients treated with the Edwards device.





Dr Dean Kereiakes



Dr Dean Kereiakes (Christ Hospital Heart and Vascular Center, Cincinnati, OH): The biggest news and excitement of 2012 surrounds transcatheter aortic-valve replacement and the evolution of novel devices and iterations to improve acute and late outcomes—for example, the ability to retract and reposition a device and to seal perivalvular leaks.



For 2013, we'll get the PARTNER II results using the next-generation Sapien XT valve and lower-profile Novoflex delivery system (Edwards Lifesciences). The nonoperative patients in PARTNER II B are extremely high risk, but the randomized cohort, where patients are randomly assigned to surgical- or transcatheter-valve replacement, includes intermediate-risk patients with an STS score of 4 or higher. By contrast, in PARTNER I A, the average STS score was 11/12. That's the biggest thing on the horizon in 2013. I'm hot for that.



- Shelley Wood















Lipids



Dr Richard Karas



Dr Richard Karas (Tufts University School of Medicine, Boston, MA): I think the most important study of 2012 in this field was unfortunately a failure and that is the Dal-OUTCOMES study. This is now the second failure of a drug in this class, but possibly for two different reasons. This sets up a major drama for the development of anacetrapib and evacetrapib, both of which are in or entering very large-scale clinical-outcomes studies. It also calls into further question the broad issue of HDL raising in general, which together with the clinical data and the newest genetic data (Mendelian randomization studies) are changing very long-held beliefs in this field.



heartwire: Any predictions?



Karas: For 2013, I would like to predict that [Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events] HPS-2 THRIVE will be positive.



— Michael O'Riordan















Prevention



Dr Nathan Wong



Dr Nathan Wong (University of California, Irvine): The biggest advance in prevention this year was the positive, significant findings regarding the efficacy of the emerging PCSK9 inhibitors for lowering LDL-C, even in patients already on high dosages of statins, and that these therapies represent a very promising means for addressing LDL-C not adequately controlled by statins.





Dr Martha Gulati



Dr Martha Gulati (Ohio State University Wexner Medical Center, Columbus): PCSK9 inhibition has moved closer to the forefront of being a possible treatment for LDL reduction. This idea of an antibody for familial hypercholesterolemia has huge implications and may also have implications for others whom we need to achieve optimal LDL but can't with traditional medications. There are still lots of things we don't know, but it is exciting to see what we find out.



Wong: For 2013, I think we are all anxiously awaiting the findings of HPS2-THRIVE, which is likely to be the final word regarding the efficacy of niacin in reducing CVD risk (in this case, beyond statin therapy). We also look forward to the release of the new ATP 4 guidelines on dyslipidemia, JNC 8 on hypertension, and new CVD risk assessment and other prevention guidelines that will hopefully be well publicized to get prevention more into the spotlight for most physicians.



Gulati: The world cares about prevention. Even US healthcare cares about prevention. Obamacare addresses this, and we are so excited to be at this point in time where people are focusing on prevention of heart disease. We need to stop treating illness and start preventing it, if we can. This change in focus is also as exciting as any new drug or technology we have out there.



— Michael O'Riordan















Surgery



Dr Timothy J Gardner



Dr Timothy J Gardner (Christiana Care Health System, Newark, DE):



The biggest advance this year in cardiac surgery in the US is the availability, under a few reasonable FDA conditions, of the Edwards transcatheter valve for inoperable and, more recently, very high-risk patients with aortic stenosis. The requirement for a "heart team" in the selection of candidates for transcatheter aortic-valve replacement (TAVR) should ensure appropriate use of this technique.



Although individual patient characteristics and clinical circumstances must be considered whenever recommending a revascularization approach, the FREEDOM trial results clearly demonstrate better five-year survival in diabetics with CABG as opposed to PCI, regardless of extent of coronary artery disease.



heartwire: Any scientific results you are looking forward to seeing in 2013?



Initial results of the [National Heart, Lung, and Blood Institute's] NHLBI's Cardiac Surgery Clinical Research Network's [CTSN] Severe Ischemic Mitral Regurgitation trial comparing valve repair and valve replacement will be available in 2013.



- Reed Miller















Vox Twitterati

We asked our Twitter followers to weigh in on what they thought was the most important news in cardiology this year, using hash-tag #topCVD2012, in 140 characters or less.



@stevedyda: My top story: Stay of execution for Obamacare, the election results for #POTUS, and impact on us heart docs.



@cpcannon: PVSK9 inhibitors for sure—a big and promising advance, and FREEDOM changed my practice.



@DrSethdb: Survival by #SCOTUS and again 11/6/2012. Major transformation of US med.



@johnrvcardio: MADIT RIT for sure. RELY-ABLE maybe too.



@PuenteyPonte: MASTER: PET micronet mesh-covered stent vs standard stents in STEMI #TCT2012.



@DrKevinCampbell: The rapid emergence of SoMe in cardiology and proliferation of e-patients.



@katherinekleon @MayoClinic puts spontaneous coronary artery dissection (SCAD) on map.



@EJSMD Gotta go with the obvious choice of the St Jude Riata/Durata saga for #topcvd2012 story.



@jamesbeckerman: The year of the TAVR!



@DrJYounger: Cardiac MRI beats nuclear for diagnosing coronary disease (and nuke performance v poor).















Editor's choice



Dr Eric Topol



Dr Eric Topol (Scripps Translational Science Institute, La Jolla, CA): I do think the FDA approval of a smartphone ECG is a big one, as it really disrupts the way an ECG can be done. . . . The renal-denervation procedure to treat hypertension is getting legs, and more data came out in 2012 to suggest it will be here to stay, with the potential for expanded application.



2012 was also a year for a big ramp-up in the use of warfarin alternatives—dabigatran, rivaroxaban, and apixiban (outside the US for the latter). Considering we have had no alternative for warfarin since 1954, this has been an important advance.



- Lisa Nainggolan











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FDA approves iPhone ECG monitor

[Arrhythmia/EP > Arrhythmia/EP; Dec 03, 2012]



Pall cast on Durata ICD lead as FDA document made public

[Arrhythmia/EP > Arrhythmia/EP; Nov 22, 2012]



FDA approves HeartWare VAD for bridging to transplant

[Heart failure > Heart failure; Nov 20, 2012]



BLOCK-HF: Replace RV pacing with BiV in AV-block heart failure

[Heart failure > Heart failure; Nov 08, 2012]



Two new PCSK9 MAbs for LDL-lowering look good in phase 2

[Lipid/Metabolic > Lipid/Metabolic; Nov 06, 2012]



dal-OUTCOMES: Wrestling with why the CETP inhibitor failed to reduce outcomes

[Lipid/Metabolic > Lipid/Metabolic; Nov 05, 2012]



FREEDOM: CABG superior to PCI in diabetic patients with coronary disease

[Interventional/Surgery > Interventional/Surgery; Nov 04, 2012]



RIVAL: Major benefits with radial PCI in STEMI vs NSTEMI

[Interventional/Surgery > Interventional/Surgery; Oct 26, 2012]



FAME II: FFR-guided PCI is cost-effective

[Imaging > Imaging; Oct 24, 2012]



Positive results for renal denervation pile up at ESC

[Hypertension > Hypertension; Aug 28, 2012]



WOEST: Drop aspirin in stent patients on oral anticoagulants

[Thrombosis > Thrombosis risk; Aug 28, 2012]



No win for prasugrel in TRILOGY ACS

[Acute Coronary Syndromes > Acute coronary syndromes; Aug 26, 2012]



ROMICAT II published: Coronary CT in the emergency department saves time screening for ACS

[Imaging > Imaging; Jul 26, 2012]



"Thrilled," "stunned," "full of hope": Reactions to Supreme Court decision

[heartwire > News; Jun 29, 2012]



2012 European HF guidelines cover new ground: TAVI, ivabradine make debuts

[Heart failure > Heart failure; May 21, 2012]



CCTA-first ER strategy safely discharges more patients: ACRIN/PA

[Imaging > Imaging; Mar 26, 2012]



"Recalled" Riata ICD leads: Brainstorming conference aims for guidance

[Arrhythmia/EP > Arrhythmia/EP; Jan 20, 2012]



Cautious optimism welcomes new CETP inhibitor, evacetrapib

[Lipid/Metabolic > Lipid/Metabolic; Nov 15, 2011]



DEFINE: Large effects on LDL and HDL cholesterol with CETP inhibitor anacetrapib

[Lipid/Metabolic > Lipid/Metabolic; Nov 17, 2010]