January 29th, 2013
ESC Gives a Shot in the Arm to Radial Access for PCI Procedures: A New Default?
Larry Husten, PHD
Radial access is now the preferred approach for percutaneous coronary interventions, according to a consensus document from the European Society of Cardiology and other European organizations and published online in EuroIntervention. However, at least one prominent U.S. interventional cardiologist thinks the “hard benefits” of radial access “are more controversial,” though he supports increased use of the newer approach.
The popularity of the radial-artery approach has grown in recent years, in large part provoked by the desire to reduce the bleeding associated with the femoral approach. This concern is heightened in acute interventions in which the use of anticoagulants and antiplatelets increase the bleeding risk. Patients treated via the radial approach are able to stand up and move around much faster than patients who are treated via the femoral approach.
The chief limitation of the radial approach is the smaller size of the radial artery, requiring smaller catheters that are not suitable in a small number of cases. The radial approach also requires retraining for physicians who have always used the femoral approach. Physicians who employ the radial approach must also know how to use the femoral approach. The European document notes that “proficiency in the femoral approach is required because it may be needed as a bailout strategy or when large guiding catheters are required.”
Another drawback to the radial approach is that the amount of radiation exposed to the patient may increase, especially in the first few procedures performed with the new approach.
In an ESC press release, co-author Marco Tubaro said:
“The radial approach strongly reduces the bleeding complication at the site of the procedure. The reduction in bleeding translates into a reduction in events and even into a reduction in mortality, particularly in patients with ST-elevation myocardial infarction (STEMI).”
The first author of the document, Martial Hamon, said:
“Overall I think there is a consensus now that the radial arteries can be used as the default access site for PCI. However we need to be aware of remaining concerns, for example risk of stroke and radiation exposure, especially during the learning curve. There also remains the issue of non-access site bleeding whatever the access site used. These issues are outlined in the paper.”
Columbia University’s Ajay Kirtane provided the following comment to CardioBrief:
“Transradial access is an important skill to learn, and I am certainly a believer in this approach (using it as the default approach for the majority of my patients). In fact, I am one of the directors of an upcoming course sponsored by the Cardiovascular Research Foundation dedicated to teaching this approach to physicians (transradialcourse.com). I do feel, however, that the evidence demonstrating reductions in mortality and even major bleeding complications is not as clearcut as is often presented. For one, the pharmacologic regimens used in these trials were more potent than many U.S. operators use (e.g., predominance of heparin plus glycoprotein IIb/IIIa inhibitors instead of bivalirudin), and additionally, vascular closure devices were rarely used in these trials. Additionally, if one looks critically at some of the radial vs. femoral trials (even in STEMI patients), there are some puzzling findings. For example, in RIFLE-STEACS, there was a 4% reduction in cardiac death and a 4.4% reduction in bleeding but virtually no difference in other outcomes. That would suggest that the reduction in cardiac death was entirely attributable to a reduction in bleeding, and that practically all bleeding events caused a death, which is hard to fathom. Thus, while I believe that there are other clear and notable benefits to the transradial approach (patient comfort, less bruising, early ambulation time) that are supported by the evidence, the ‘hard benefits’ of transradial access are more controversial, in my opinion. I do concur that it is essential for operators to train in both techniques, and that there will be situations where femoral access will clearly be preferred.”
January 28th, 2013
Study Warns Against Dual Blockade of Renin-Angiotensin System in Heart Failure and Hypertension
Larry Husten, PHD
The enormous success of ACE inhibitors in hypertension and heart failure spurred hope that adding a second drug to block the renin-angiotensin system would yield improved outcomes. Although definitive evidence supporting dual blockade of the renin-angiotensin system has never been found, more than 200,000 patients in the U.S. currently receive this therapy. Now a large new meta-analysis suggests that dual blockade results in no improvement in mortality, but is associated with an increase in important adverse events.
In a paper published online in BMJ, Harikrishna Makani and colleagues at Columbia University and New York University performed a meta-analysis of more than 68,000 patients who were enrolled in clinical trials comparing dual blockade of the renin-angiotensin system with monotherapy. They found no significant difference between the groups for all-cause mortality or cardiovascular (CV) mortality, although dual blockade was associated with a significant 18% reduction in hospital admission for heart failure (HF):
- All-cause mortality: RR 0.97, CI 0.89-1.06
- CV mortality: RR 0.96, CI 0.88-1.05
- HF admission: RR 0.82, CI 0.74-0.92
However, any neutral or positive effect was offset by significant increases in hyperkalemia, hypotension, and renal failure. People on dual blockade were also more likely to withdraw from therapy because of adverse events:
- Hyperkalemia: RR 1.55, CI 1.32-1.82
- Hypotension: RR1.66, CI 1.38-1.98
- Renal failure: RR 1.41, CI 1.09-1.84
- Withdrawal due to adverse events: RR 1.27, CI 1.21-1.32
The authors note that nearly all the data supporting dual blockade “are based on evidence from surrogate endpoints,” showing, for instance, that dual blockade reduced proteinuria or reduced the risk of end-stage renal disease or the time to doubling of serum creatinine. The authors write:
The present data evolving from studies with dual blockade of the renin-angiotensin system should be a reminder that many purported benefits of such therapy was solely based on data using surrogate endpoints. Surrogate endpoints not uncommonly fail to emulate hard outcomes endpoints and leapfrogging from surrogate data cannot substitute for the exposure of patients in clinical outcome studies.
They conclude:
Although dual blockade of the renin-angiotensin system may have seemingly beneficial effects on certain surrogate endpoints, it failed to reduce mortality and was associated with an excessive risk of adverse events such as hyperkalaemia, hypotension, and renal failure when compared with monotherapy. The overall risk to benefit ratio argues against the use of dual therapy.
January 28th, 2013
Getting a Read on St. Jude Leads: An Interview with Robert G. Hauser
Robert George Hauser, BS MD and John Ryan, MD
In August 2012, Dr. Robert G. Hauser and colleagues from the Minneapolis Heart Institute published a paper analyzing failures of St. Jude Durata and Riata ST Optim ICD leads. Last week the FDA released a warning letter previously sent to St. Jude indicating serious violations found in a California plant manufacturing these leads and that the company’s response has not been adequate. CardioExchange’s Dr. John Ryan asked Dr. Hauser about the problems with these products.
Dr. Ryan: Do you feel vindicated having being among the first to highlight the issues with the Riata leads?
Dr. Hauser: Disturbed more than vindicated. Why does it take a major device recall for the FDA to uncover manufacturing deficiencies in a Class 3 product?
Dr. Ryan: What do you think is the path forward for oversight of ICD leads and similar devices?
Dr. Hauser: Creation of a transparent active post-market surveillance system for all implantables but certainly for lifesaving/life supporting devices.
Dr. Ryan: What are your recommendations to your patients that have Riata and Durata leads?
Dr. Hauser: We are evaluating every patient who received a Riata lead and deciding if prophylactice replacement is appropriate. Of particular concern is short-circuiting, which can be fatal if it occurs during shock delivery for Ventricular Fibrillation and Ventricular Tachycardia; this is usually due to a short between a high voltage cable and a shocking coil, and it has been seen in Riata leads that appeared to be functioning normally based on standard testing. In regard to Durata, we no longer implant this lead. I believe Durata has the same design flaw as Riata but we need long-term data to prove this hypothesis one way or the other.
What are you doing for patients with these leads? Are there steps that you think need to be taken to make these devices safer?
January 25th, 2013
Appropriate Use or Defensive Medicine?
Sarah C. Hull, MD, MBE (Master of Bioethics)
One of the most popular buzzwords we hear in cardiology circles lately is “appropriate use.” Gone are the days of unlimited testing and reimbursement as we are increasingly asked to provide an evidence-based rationale to justify our decision to order tests. As cardiology fellows, this is becoming a key part of our education; a lecture on stress testing, for example, would not be complete without at least a few slides addressing the spectrum of appropriate use criteria for various indications.
The concept of appropriateness is important for two reasons. The first reason, which is getting so much press in the “Obamacare” era, is that ordering inappropriate tests is a colossal waste of money, and we are finally being asked to recognize that we operate in a world of limited resources. (Note that I expressly avoid the term “rationing”, despite the exhortations of various fearmongers, as rationing has taken place in some form or another since medicine became a profession. It is just now that we are debating how we should ration it differently in perhaps a more equitable or efficient fashion.) However, I would argue that the second, and even more compelling, reason to limit testing to truly appropriate use is that inappropriate testing often leads to incidental findings and false-positive results that at best lead to more inappropriate testing and at worst lead to unnecessary treatment with potentially deleterious complications. Simply put, inappropriate testing is suboptimal patient care.
So what is the problem? As so often is the case, there is a hidden curriculum that drives a wedge between theory and practice. As a cardiology fellow, I have been repeatedly surprised by some of the tests I have been asked to perform for arguably inappropriate indications. For example, in the initial (read: naive) months of my fellowship, while on a nuclear imaging rotation, I was asked to perform a stress test on a gentleman with no risk factors other than age whose nonexertional pleuritic chest pain (which he only experienced after paroxysms of coughing and was reproducible to palpation) was clearly due to his resolving bronchitis. After performing my own focused history and physical, I approached the ordering physician to discuss the case because I believed this patient did not need further work-up of his chest pain and did not want to expose him to unnecessary radiation (or the risk of a false-positive result). The response was not a medical justification of the test; instead, I received a lecture on the exceedingly low risk tolerance of the American public and this physician’s own desire to avoid a lawsuit at all costs.
This example is perhaps extreme, but I have heard many of my fellow colleagues describe similar situations, and I am concerned that the practice of defensive medicine is overriding the implementation of appropriate use to the detriment not only of economics and patient care, but also of medical education. If we learn that it is completely acceptable to look the other way when we know tests or procedures are not indicated, we will only perpetuate this cycle of inappropriate use. There is no doubt that we need a huge overhaul of medical litigation in this country (starting with a rule that a losing plaintiff must pay for the entirety of an exonerated defendant’s legal costs in order to discourage frivolous lawsuits), but at the same time, we as physicians have an obligation to uphold the standards of appropriate use. We owe it to our economy, to our patients, and to our trainees.
January 24th, 2013
Hospital Readmissions May Be Just the Tip of the Iceberg
Anita Vashi, MD, MPH
The period after hospital discharge is full of challenges and, often, dangers. Well-intended efforts to improve the transition from hospital to home often rely on hospital readmission rates to measure success — but that measure may miss the point.
As an emergency medicine physician, I see an alarming number of patients return to the ED soon after hospital discharge. Of course, some come back for acute, unforeseen complications, but many others return because of a breakdown in social support or difficulty accessing and communicating with providers. Quite a few merely require clarification of their expected course of recovery or symptom management and are safely discharged home. Return ED visits that arise from an unmet need or gap in care contribute to an overall fragmentation of care, to ED overcrowding, and to higher costs.
My colleagues and I conducted a study, just published in JAMA, to determine to what extent treat-and-release ED encounters contribute to overall use of acute-care services after hospital discharge. Analyzing data from 5 million hospitalizations during 2008 and 2009 in three states (California, Nebraska, and Florida), we found that for every 1000 discharges, there were 97.5 ED treat-and-release visits and 147.6 hospital readmissions in the 30 days after discharge. Visits to the ED represented nearly 40% of all post-discharge acute-care encounters. Moreover, patients often returned to the ED for reasons related to their initial hospitalization.
I am concerned that hospital quality measures do not fully capture the many patients who seek acute care after hospital discharge and do not reflect the substantial post-discharge care that EDs provide. I fear that looming crackdowns on hospital readmissions may have unintended consequences. When patients return to the ED, will I be encouraged, even pressured, to avoid readmitting them? If so, how safe is it to discharge patients for whom outpatient care has already failed once?
I have become convinced that ED utilization can be a useful, patient-centered metric to track, along with rehospitalization rates. Even if readmission rates drop, high or increasing rates of ED use may uncover care deficiencies during the precarious transition from hospital to home. To improve the transition, physicians will need to think less about measures and incentives — and more about individual patients’ needs. Why are patients returning to the ED and the hospital in droves? Are we not educating them well enough about home transition? Do we lack capacity in the system for care teams to coordinate follow-up care when patients have a complication? We clearly must do a better job of anticipating and meeting patients’ needs — before they return to the ED.
It is no surprise that patients recovering from a recent hospitalization have difficulty navigating our complex health care system. Indeed, they shouldn’t leave the hospital without a realistic care plan. “See your doctor in 2 weeks and return to the ED if feeling worse” doesn’t cut it. An ideal plan would monitor a patient’s post-discharge recovery process. That might require providing patients with innovative venues and opportunities for asking questions. We must also think creatively about ways to deliver care and guidance effectively outside of EDs and hospitals.
My questions to you:
1. Do you know when your patients end up back in the ED but are not rehospitalized?
2. How do you help your patients avoid post-discharge acute ED visits and hospital readmissions?
January 22nd, 2013
Trials of Niacin and AF Device Will Headline American College of Cardiology Program
Larry Husten, PHD
Two big trials will highlight this year’s American College of Cardiology (ACC) meeting in March in San Francisco. First is the PREVAIL trial testing Boston Scientific’s long-anticipated Watchman left atrial appendage closure device for stroke prevention in patients with atrial fibrillation (AF). Second is the detailed presentation of the controversial failed HPS2-THRIVE trial of extended-release niacin and laropiprant. The final list of trials has been posted on the ACC website.
Boston Scientific’s Watchman device has been the subject of intense interest since the PROTECT AF trial in 2009. However, the FDA raised numerous questions about the device and, despite a positive recommendation from the Circulatory Systems Devices panel, required the company to perform a new pivotal trial. That trial, PREVAIL (Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy), will be presented on Saturday, March 9, at the ACC. The trial was designed to confirm the overall finding of the earlier trial that Watchman was noninferior to standard warfarin therapy (PROTECT) and to address lingering safety and efficacy issues raised by that trial.
In December, Merck disclosed that the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) had failed to meet its primary endpoint. The trial, which was the largest-ever study of niacin, found no benefit, and a signal of harm, for the combination of a statin and the combination of extended-release niacin and laropiprant when compared to statin therapy alone in 25,673 patients at high risk for cardiovascular events. Interest in the detailed results of the trial is keen. Experts will sift the tea leaves for any clues the trial may provide about the viability of the HDL hypothesis, while some experts believe that niacin may yet prove to be found beneficial.
Also of particular interest will be the PARTNER 2, Cohort B trial, testing the next generation of Edwards’ transcatheter aortic valve replacement (TAVR) system in patients with aortic stenosis who are not candidates for surgery. Partner 2, however, is not expected to attract the same attention as the original PARTNER trials, as TAVR this year has started to enter clinical practice in the U.S. and is no longer the subject of much controversy.
Another trial of interest is the CHAMPION PHOENIX Trial. According to the Medicines Company, which released top line results earlier this month, the trial found that the new antiplatelet drug cangrelor was superior to clopidogrel in reducing ischemic events at 48 hours in PCI patients. Nearly 11,000 patients scheduled for PCI for either stable angina or an acute coronary syndrome were enrolled in the study.
The REMINDER Trial tested the effect of the early adminstration of eplerenone in approximately 1,000 patients with acute MI but without heart failure. The primary endpoint is the time to cardiovascular mortality, rehospitalization, or extended initial hospital stay due to diagnosis of heart failure or sustained VT/VF.
Following the highly controversial presentation of the initial results of TACT (Trial to Assess Chelation Therapy) last year at the AHA, which raised the possibility that chelation therapy might be beneficial, the TACT investigators will present the results of the second part of the trial, in which patients were randomized to an oral high-dose vitamin and mineral supplement or placebo.
Here is the ACC’s complete list of late-breaking clinical trials:
Late-Breaking Clinical Trials I
Saturday, March 9, 8 – 10 a.m.
- Final Results of Randomized Trial of Left Atrial Appendage Closure Versus Warfarin for Stroke/Thromboembolic Prevention in Patients with Non-Valvular Atrial Fibrillation (PREVAIL)
- HPS2-THRIVE: Randomized Comparison Of Extended-Release (ER) niacin/laropiprant 2g Daily Versus Placebo in 25,673 Patients At High Risk Of Occlusive Vascular Events
Late-Breaking Clinical Trials II: Interventional
Sunday, March 10, 8 – 9:30 a.m.
- Early High-Dose Rosuvastatin for Contrast-Induced Nephropathy Prevention in Acute Coronary Syndrome
- A Randomized Evaluation of the SAPIEN XT Transcatheter Valve System in Patients with Aortic Stenosis who are not Candidates for Surgery: PARTNER 2, Cohort B Outcomes
- One-year Outcome of a Trial Comparing Second Generation Drug-eluting Stents Using Either Biodegradable Polymer or Durable Polymer: the NOBORITM Biolimus-Eluting versus XIENCETM/PROMUSTM Everolimus-eluting Stent Trial (NEXT)
- Comparison of DK crush versus culotte stenting for unprotected distal left main bifurcation lesions: Results from a multicenter, randomized, prospective DKCRUSH-III study
- The Main Results of the CHAMPION PHOENIX Trial
Late-Breaking Clinical Trials III: Chronic CAD/Stable Ischemic Heart Disease and Acute Coronary Syndromes
Sunday, March 10, 10:45 a.m. – 12:15 p.m.
- The STREAM Trial
- Early Administration of Eplerenone in Patients with Acute Myocardial Infarction Without Heart Failure: Results of the Randomized, Double-Blind, Placebo-Controlled REMINDER Trial
- Effects of the P-Selectin Antagonist Inclacumab in the Select-Acute Coronary Syndromes Trial
- Randomized Comparison of High-dose Oral Vitamins vs. Placebo in the Trial to Assess Chelation Therapy
- Evaluation of Ranolazine in Patients with Type 2 Diabetes Mellitus and Chronic Stable Angina: Results from the Type 2 Diabetes Evaluation of Ranolazine in Subjects with Chronic Stable Angina (TERISA) randomized clinical trial
Late-Breaking Clinical Trials IV: General Cardiology
Monday, March 11, 8 – 9:30 a.m.
- Three-Year Outcomes after Transcatheter or Surgical Aortic Valve Replacement in High-Risk Patients with Severe Aortic Stenosis
- A Randomized Trial to Compare Percutaneous Coronary Intervention between Massachusetts Hospitals With Cardiac Surgery On-Site and Community Hospitals Without Cardiac Surgery On-Site
- The German Off-Pump Coronary Artery Bypass Grafting in Elderly Patients (GOPCABE) Study
- CORONARY: The Coronary Artery Bypass Grafting Surgery Off or On Pump Revascularization Study. Results at 1 year
- PRAGUE-6 Trial: Off-Pump Versus On-Pump Coronary Artery Bypass Graft Surgery in Patients With EuroSCORE ≥6
Late-Breaking Clinical Trials V: Heart Failure
Monday, March 11, 10:45 a.m. – 12:15 p.m.
- The St Vincent’s Screening To Prevent Heart Failure Study: Impact of Natriuretic Peptide Guided Screening and Treatment on Long-Term Prevalence of Left Ventricular Dysfunction, Heart Failure and Cardiovascular Events
- Digoxin Reduces 30-Day All-Cause Hospital Admission in Ambulatory Older Patients with Chronic Heart Failure and Reduced Ejection Fraction
- The ASTRONAUT Study: Aliskiren Trial On Acute Heart Failure Outcomes
- Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in Diastolic Heart Failure (RELAX) Trial
January 22nd, 2013
Renal Denervation: Delineating Its Uses, Misuses, and Possibilities
Murray David Esler, MBBS PhD and John Ryan, MD
Renal denervation as a treatment for drug-resistant hypertension—already approved in many parts of the world and seemingly headed for approval here in the U.S.—remains a controversial topic with a lot of uncertainty. To shed some light on the issue, CardioExchange’s Dr. John Ryan posed some questions to Dr. Murray David Esler, a pioneer in the field.
Dr. Ryan: In the two-year follow up from Symplicity HTN-1 and Symplicity HTN-2, there was sustained reduction in systolic blood pressure of 25 to 30 mmHg. For how long do you suspect this reduction can be maintained? Does re-innervation of the kidneys result in the blood pressure increasing again or will the kidneys be more resistant?
Dr. Esler: The patient with the longest follow up is now at 5 1/2 years. In this patient, and others with long-term follow up, there has been no loss of antihypertensive effect of renal denervation over time. It was anticipated that sympathetic reinnervation of the kidneys might perhaps cancel out the BP lowering effects, but the stability of blood pressure lowering in these patients argues against substantial reinnervation. It would be possible to test for reinnervation, using renal norepinephrine spillover measurements, which quantified the initial renal denervation, but this has not been done to-date.
Dr. Ryan: The data on renal artery denervation currently demonstrate the reduction in blood pressure, but we have no published clinical endpoints (heart attack, strokes, mortality): What effect would you expect devervation to have on real patient outcomes?
Dr. Esler: If it can be maintained, the degree of blood pressure reduction achieved with renal denervation in drug-resistant hypertension—approximately 30 mm Hg systolic—would predict a substantial reduction in risk of cardiovascular endpoints. With a starting systolic BP of 180 mm Hg, this would be perhaps a 40% reduction in risk. This does remain conjectural, although likely, in the absence of renal denervation trials which have directly tested for reduction in clinical outcomes.
Dr. Ryan: From a societal standpoint, introducing healthy lifestyle and weight loss is likely preferable to renal artery denervation for reducing hypertension. However, practitioners may be tempted to choose denervation with the view that behavioral modification is so difficult. Are you concerned that patients may undergo renal artery denervation before other treatments are tried? How would you prevent any overuse, if at all?
Dr. Esler: Non-pharmacologic antihypertensive measures must remain the starting point for patients with hypertension, but will often not be enough. Renal denervation should be reserved for patients in whom behavior modification combined with adequate and skillful antihypertensive drug prescribing cannot achieve BP reduction to target. There are no clinical trial data to support renal denervation in hypertension outside of this setting. In countries where the “genie is out of the bottle”, and clinical use is authorized, prevention of overuse will be difficult. In some instances government regulations will confine the use of renal denervation to drug-resistant hypertension. Insurer or governmental reimbursement rules should be framed to prevent overuse.
Dr. Ryan: Many expect this intervention to be a ‘cure’ for hypertension. Based on your experience, do you believe that this procedure will ultimately result in many previously hypertensive patients no longer requiring antihypertensive medication?
Dr. Esler: The available evidence is that renal denervation will not cure drug-resistant hypertension, which of course would be hoping for too much. Approximately 40% to 50% of patients do achieve target BP (140 mm Hg systolic), but this requires the denervation procedure plus continuation of perhaps 3-4 of their tablets. The denervation is ancillary to antihypertensive medication. I share a dream with some other researchers that renal deveration might in fact cure milder grades of hypertension, so that drug-naive patients might never have to receive medication. We are just beginning to establish trials to test this, but the idea is perhaps fanciful.
January 22nd, 2013
How Will You PROTECT Your Patients with Nonvalvular Afib?
Eiman Jahangir, MD
Of all the medications in my clinical repertoire, none elicits more groans from my patients than warfarin. As soon as I mention it, most of them are vaguely aware of what’s coming: burdensome INR checks, frequent dose adjustments, dietary restrictions, and risk for bruising or something worse. In short, warfarin’s bruised reputation precedes itself. That’s why results from the PROTECT AF trial, published in Circulation, piqued my interest.
THE STUDY
In this trial, 707 patients with nonvalvular atrial fibrillation (AF) and at least one CHADS2 risk factor were randomized to undergo percutaneous left atrial appendage (LAA) closure with the Watchman filter device or to receive ongoing warfarin therapy. The primary composite endpoint was the incidence of stroke, systemic embolism, or cardiovascular death. Mean follow-up was 2.3 years. The device maker funded the trial.
The compelling results:
1. LAA closure with the Watchman device was noninferior to warfarin. Incidence of the primary endpoint, per 100 patient-years, was 3.0% in the device group and 4.3% in the warfarin group (relative risk, 0.71; 95% CI, 0.44%–1.30%).
2. The device’s failure to achieve superiority was related to acute, procedure-related stroke events. The primary adverse-outcome rate was 5.5% for Watchman and 3.6% for warfarin (RR, 1.53; 95% CI, 0.95–2.70); most of the events occurred early. Otherwise, rates remained lower in the device group than in the warfarin group throughout follow-up.
3. Superiority of the device was found in secondary analyses aimed at isolating the effect of LAA closure from that of transient concomitant antithrombotic therapy. The adverse events, mainly bleeding, were similar in the two groups while on antithrombotic therapy. However, after patients completed interim antithrombotic therapy (warfarin for 45 days, then clopidogrel for 4.5 months after device deployment), major bleeding was significantly less common with the device than with warfarin (RR, 0.35; 95% CI, 0.16–0.79).
4. LAA closure had a sustained benefit in secondary prevention of stroke. The event rate was 5.3% for Watchman versus 8.2% for warfarin (RR 0.64; 95% CI, 0.24–1.74)
MY VIEW
Given these results, we cardiologists now have three options to offer patients with nonvalvular AF: warfarin, novel anticoagulants (dabigatran, rivaroxaban, and apixaban), and the Watchman device. As a consultative cardiologist, I have three main thoughts about this new reality.
First, I find the prospect of avoiding frequent INR checks, constant dosage adjustments, and concern about sub- and supratherapeutic INR levels very attractive. However, we can avoid these problems using the novel anticoagulants without exposing patients to the risks of an invasive procedure. Thus, if avoiding the hassles of warfarin administration is the objective, I will have a frank discussion with my patients about treatment risks and benefits, as well as their own expectations. I suspect some patients will shy away from the procedure while others will do anything to avoid taking another pill. So I’m not sure which option will ultimately be favored most often.
Second, I foresee a potential niche for the Watchman device (not unlike the niche for bioprosthetic valves) in patients at high risk for bleeding. Consider the patient scheduled for an elective surgery that can be delayed until after the 6-month anticoagulation period; or the young patient who wishes to avoid long-term anticoagulation; or someone whose very active lifestyle predisposes him to potential trauma.
Third, we need further exploration of the risk of performing direct cardioversion (DCV) in people who undergo the Watchman procedure. Will DCV be safe in a patient off warfarin with a Watchman device in place? Will a patient who requires frequent DCV need to repeatedly take warfarin for brief periods?
The Watchman device now has a class IIb recommendation in the 2012 focused update of the European Society of Cardiology’s atrial fibrillation guidelines. Given the data from PROTECT AF and this new recommendation, I pose three questions to you:
1) Will you begin using the Watchman device as an alternative to warfarin in most patients with nonvalvular AF?
2) Will you use the device in your patients with contraindications to warfarin, a group not evaluated in this trial?
3) Will you let your patients make the Watchman vs. warfarin choice themselves?
January 21st, 2013
Selections from Richard Lehman’s Literature Review: January 21st
Richard Lehman, BM, BCh, MRCGP
CardioExchange is pleased to reprint selections from Dr. Richard Lehman’s weekly journal review blog at BMJ.com. Selected summaries are relevant to our audience, but we encourage members to engage with the entire blog.
NEJM 17 Jan 2013 Vol 368
A Review of Drug-Eluting Stents (pg. 254): It’s time to stop watching the snow falling by the lamp-posts, close the curtains, poke the fire and get out some old DVDs. Now what have we here? The Star Wars trilogy, Lord of the Rings, Agatha Christie’s Poirot: the Complete Collection—and oh look, Drug Eluting Stents from NEJM studios. Starring Giulio Stefanini as Sirolimus and David Holmes as Paclitaxel. How about it, folks? Nah—let’s have Game of Thrones. We prefer bare metal.
Lancet 19 Jan 2013 Vol 381
Hypertrophic Cardiomyopathy (pg. 242): Many Lancet seminars get bogged down in endless genomic detail and speculation, but because most hypertrophic cardiomyopathy has now been shown to be due to mutations of just 11 genes, the authors can concentrate on clinical issues, which they do very well. “After more than 50 years, hypertrophic cardiomyopathy has been transformed from a rare and largely untreatable disorder to a common genetic disease with management strategies that permit realistic aspirations for restored quality of life and advanced longevity.”
January 18th, 2013
Media Coverage of Research: Does It Sometimes Miss the Point?
Harlan M. Krumholz, MD, SM
Sometimes when I see a new study in the media I wonder about the coverage. The media spin often makes it seem that the researchers are studying the obvious. Today I saw a headline in the American College of Cardiology CV News Digest that blared: “Postop Mortality May Be High When CPR is Required.” MedPage Today, Medwire, and Medscape covered this study. I have not read the paper, but fully accept that the conclusion is true. Still, I couldn’t help to wonder about it. Here is the blurb:
Study: Postop Mortality May Be High When CPR Is Required.
MedPage Today (1/18, Smith) reports, “One surgical patient in 203 had a cardiac arrest and needed cardiopulmonary resuscitation (CPR) either during or after surgery, according to analysis of a large 5-year database.” However, “fewer than one patient in five who had CPR survived to discharge in 30 days and the risk of death increased as the number of comorbidities rose, according to” researchers. The investigators found that approximately “three-quarters of patients who had CPR had a complication, such as sepsis, on or before the day of CPR.” The research was published in JAMA Surgery.
MedwireNews (1/18, McDermid) reports that “the most common complications were intubation (in 46.5% of patients), prolonged ventilator use (37.0%), septicemia (33.5%), renal impairment (17.7%), pneumonia (17.3%), and bleeding (16.0%).”
Medscape (1/18, Fox) reports that, according to the researchers, “Complications commonly precede arrest; prevention or aggressive treatment of these complications may potentially prevent CPR and improve outcomes. These data could aid discussions regarding advance directives among surgical patients.”
Do you encounter studies or coverage that make you wonder: Was that really a research question?
NEJM Journal Watch — Recent Cardiology Articles- 5-Year Outcomes of TAVR vs. Surgery in Low-Risk Patients
- Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement — Another Swing and a Miss
- An Update on Sudden Cardiac Arrests in Marathon Runners
- An Oral PCSK9 Inhibitor for Lowering LDL-C?
- Pulsed Field Ablation vs. Cryoablation in Paroxysmal Atrial Fibrillation