Category Archives: Interventional Cardiology & Surgery

Novel Leadless Pacemaker Makes Debut At HRS 2013 Reply

by • Heart Rhythms, Interventional Cardiology & Surgery • Tags: , , ,

First results in human patients of a novel leadless pacemaker were presented last week at the HRS meeting in Denver by Vivek Reddy.  Pacemaker leads are the most common source of complications associated with pacemakers today. The self-contained device is delivered via catheter to the right ventricle, to which it is attached with a fixation mechanism.  The device is manufactured by Nanostim, Inc, a small company which is being acquired by St. Jude Medical.

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Click here to read the full story on Forbes.

 

 

Leadless

 

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Encouraging 4 Year Results For Watchman Device In AF Patients Reply

by • Heart Rhythms, Interventional Cardiology & Surgery, Policy & Ethics • Tags: , , , , ,

Encouraging long-term results from the PROTECT AF trial comparing the Watchman left atrial appendage closure device to warfarin in atrial fibrillation patients were presented yesterday at the Heart Rhythm Society meeting in Denver.

Previously, the main results of the trial, published in the Lancet, demonstrated that the Watchman was noninferior to warfarin, but the total number of events in the trial was small. In addition, there were more safety problems, as might be expected, in the early days after implantation. The FDA required the company to perform a confirmatory trial. That trial, PREVAIL, has been the subject of considerable controversy. Now, long term followup of PROTECT AF may help better understand the risks and benefits of the device.

Vivek Reddy presented 4 year followup results from PROTECT AF. The primary efficacy endpoint– the combined rate of all stroke, cardiovascular or unexplained death and systemic embolism– occurred in  2.3% of the device group versus 3.8% of the warfarin group (RR 0.60, CI 0.41-1.05).

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Click here to read the full story on Forbes.

 

 

 

Edwards CEO Sold Stock 2 Weeks Before It Tanked 2

by • Interventional Cardiology & Surgery, People, Places & Events, Policy & Ethics • Tags: , ,

(Updated) Earlier this week the stock of Edwards Lifesciences tanked after the company announced weak Sapien sales and lowered its sales guidance for the rest of the year. The stock, which had been trading in the low 80s for the past month, dropped a heartbreaking 22% on Wednesday in response to the news and closed at 65 on Thursday.

But Edwards chairman and CEO Michael Mussallem didn’t suffer along with his shareholders. As reported by GuruFocus, Mussallem sold 35,000 shares of his stock on April 10 at 83.37 per share netting him nearly $3 million. Another executive, the corporate VP of Japan and Intercontinental, Huimin Wang, sold 4,850 shares at $81.74 per share.

The dramatic drop in Edwards’ stock is another sign that the market for transcatheter heart valves has not grown as rapidly as many had expected. “Edward’s initial 2013 guidance clearly proved to be overly aggressive on U.S. TAVR sales as capacity constraints and the complexities of bringing a 20+ person team up the learning curve clearly tempered the adoption curve more than expected,” said a Leerink Swann analyst quoted by Bloomberg.

Update: I have been informed by Edwards that the recent sale was part of a predetermined plan to sell shares. Mussallem has sold 35,000 shares each month since June of 2012.

Study Suggests Benefit For Beta Blockers During Noncardiac Surgery Reply

by • Interventional Cardiology & Surgery, Prevention, Epidemiology & Outcomes • Tags: , , ,

The use of perioperative beta-blockade for noncardiac surgery has been declining as a result of the controversial POISE study, which turned up evidence for harm associated with extended-release metoprolol in this setting. Now a large new observational study published in JAMA offers a contrary perspective by suggesting that perioperative beta-blockade may be beneficial in low- to intermediate-risk patients. But without better evidence the debate about this topic is unlikely to be resolved.

Martin London and colleagues performed a retrospective analysis of 136,745 patients who underwent noncardiac surgery at VA hospitals, 40% of whom received beta-blockade.

Click here to read the full story on Forbes.

 

Vena Cava Filters: Little Evidence And Wide Variation In Use Reply

by • Interventional Cardiology & Surgery, Policy & Ethics • Tags: , , , ,

Despite the absence of any evidence demonstrating benefit or showing how best to use them, vena cava filters (VCF) are used in most hospitals. Now a new study published in JAMA Internal Medicine suggests that this same lack of evidence results in an extremely broad rate of use in different hospitals. An accompanying viewpoint raises the question: “how could a medical device be so well accepted without any evidence of efficacy?”

Researchers conducted a retrospective observational study that compared the frequency of VCF use in 236 California hospitals by analyzing data from 130,643 acute VTE hospitalizations over four years. Overall, the rate of VCF placement was 14.95%, but there was a very broad variation in the percentage of acute VTE cases in which a VCF was placed, from 0% to 38.96%. The authors said that this finding places VCF “among surgical procedures with the greatest variation in geographic studies in the United States.” Even after adjusting for differences in patient populations between hospitals, the variation between hospitals remained significant.

Click here to read the full story on Forbes.

English: Taken by user:BozMo URL at http://cat...

English: Taken by user:BozMo URL at http://catesfamily.org.uk Picture of used inferior vena cava filter, showing the hook at top for removal via Jugular Vein, the umbrella structure and the leg spikes to fix in place. (Photo credit: Wikipedia)

The PREVAIL Fail Revisited: Spinning The Truth 1

by • Interventional Cardiology & Surgery, People, Places & Events, Policy & Ethics • Tags: , , , , ,

SPIN
The biggest story at the American College of Cardiology meeting last week was the missing story. As reported here and just about everywhere else, the PREVAIL trial, probably the most-anticipated late-breaker of the meeting, was pulled from the program at the last minute by the ACC leadership after Boston Scientific broke the embargo by issuing a press release several hours before the scheduled presentation.

To understand this event we first need to know what happened in the week before the ACC. And there’s a major gap in the story that has not come out before that I think holds the key to a full understanding of the story.

More than a week before the scheduled presentation I received an email invitation from a PR firm representing Boston Scientific:

“If you have any interest in speaking about the trial under embargo with Dr. Ken Stein, chief medical officer, Cardiac Rhythm Management, Boston Scientific, I have a few slivers of availability early next week. As you know, the embargo lifts at the time of presentation and I’ll need written confirmation of your embargo agreement.”

Now I’ve been down this road before, as some of you may recall. Several years ago I was offered embargoed access to data from an important upcoming trial by Medtronic (suggesting that this is a systemic problem) under the condition that I agree to a briefing from a trial investigator. I told the company that I would respect the embargo but that I wanted to review the data on my own and that I would get back to them if I had any questions. Their response: no briefing, no data.

Here’s the problem in both cases: forcibly linking access to the trial data with a company-arranged briefing is an egregious perversion of the embargo system.

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Click here to read the full post on Forbes.

 

Two Trials Explore On-Pump Versus Off-Pump Bypass Surgery Reply

by • Interventional Cardiology & Surgery • Tags: , , , , ,

Two large trials presented at the American College of Cardiology meeting in San Francisco and published simultaneously in the New England Journal of Medicine provide important new information about the ongoing debate over whether CABG should be performed with or without cardiopulmonary bypass. The combined results suggest that both techniques can be effective, and that surgeons should choose the technique with which they are most familiar and comfortable.

Previous 30-days results from CORONARY (CABG Off or On Pump Revascularization Study), which randomized 4,752 patients to on-pump or off-pump CABG, showed no significant difference in the primary outcome (death, MI, stroke, or new renal failure requiring dialysis) between the two groups. However, patients in the off-pump group required more repeat revascularization procedures, though they had lower rates of bleeding, acute kidney injury, and respiratory complications.

Now, one-year results from CORONARY have found no significant difference in the primary outcome between the groups at 1 year (12.1% in the off-pump group versus 13.3% in the on-pump group (HR 0.91, CI 0.77-1.07, p=0.24). There were also no significant differences in the individual components of the endpoint. In addition, there were no significant differences in recurrent angina (1% versus 0.9%) or the need for repeat revascularization (1.4% versus 0.8%).

A quality of life substudy found no differences between the two groups at any time point in the first year. A neurocognitive substudy found less deterioration in one assessment of neurocognitive function in the off-pump group at discharge but found no significant differences at 30 days or at 1 year. There were no differences at any time between the two groups in two other tests of neurocognitive function.

“The CORONARY study shows that off-pump bypass is just as good as on-pump. Therefore, surgeons should tailor their surgical approach to their technical expertise and expected technical difficulty,” said Andre Lamy, lead author of the study, in an ACC press release.

In the GOCABE (German Off-Pump Coronary Artery Bypass Grafting in Elderly Patients) study, 2,539 patients 75 years of age or older were randomized to on-pump or off-pump CABG. The primary endpoint was the composite of death, stroke, MI, repeat revascularization, or new renal-replacement therapy at 30 days and one year.

At 30 days there was no significant difference in the primary endpoint: 7.8% for the off-pump group versus 8.2% for the on-pump group (OR 0.95, CI 0.71-1.28, p=0.74). However, there were more repeat revascularizations in the off-pump group at 30 days: 1.3% versus 0.4%, OR 2.42, CI 1.03-5.72, p=0.04. At one year there were no significant differences between the groups in the composite endpoint (13.1% versus 14%, HR 0.93, CI 0.76-1.16, p=0.48) or in any of the individual components of the composite endpoint.

The authors write that their trial “does not support the assumption that off-pump CABG can improve the early outcome in high-risk patients.”

During the discussion section lead investigators for both studies, Anno Diegeler for GOCABE and Andre Lamy for CORONARY, emphasized that their results depended on having expert surgeons highly qualified in both techniques.

Choice of the technique, said Diegeler, should depend on clinical characteristics, patient choice, and surgeon experience.

Chris Cannon, a panel discussant, asked the question:”why would you want to do off-pump since it’s no better and it’s harder to do?” At the ACC news conference, Mark Davies said that “these trials may temper our enthusiasm for off-pump surgery.” In the US, with the advent of publicly reported STS (Society for Thoracic Surgeons) scores for individual hospitals and amateurs, there will no room for amateurs. “If you’re an amateur at it you should give it up.” Neil Kleiman had a recommendation: “if you’re going to do it you damn well better be good at it… there’s no room for sloppiness.”

 

Cangrelor During PCI May Reduce Ischemic Events Reply

by • Interventional Cardiology & Surgery • Tags: , , ,

In the Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION PHOENIX) trial, the intravenous platelet inhibitor cangrelor was tested for its effect on ischemic events associated with PCI. Cangrelor is a potent, fast-acting and reversible  agent. Results of the trial were presented at the ACC in San Francisco and published simultaneously in the New England Journal of Medicine.

A total of 11,145 PCI patients were randomized to a bolus and infusion of cangrelor or to a loading dose of clopidogrel. A primary endpoint event — death, MI, ischemia-driven revascularization, or stent thrombosis at 48 hours — occurred in 4.7% of the cangrelor group versus 5.9% of the clopidogrel group (adjusted OR, 0.78; 95% CI, 0.66-0.93; P=0.005). The authors calculated that 84 patients would need to be treated with cangrelor instead of clopidogrel to prevent one primary endpoint event.

Note to readers: Don’t miss this fascinating post on CardioExchange in which CHAMPION PHOENIX co-chair Deepak Bhatt responds to questions raised by Rick Lange and David Hillis in their New England Journal of Medicine editorial.

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Click here to read the full story on Forbes.

Following An Embargo Break PREVAIL Trial Won’t Be Presented At ACC 2

by • Heart Rhythms, Interventional Cardiology & Surgery, People, Places & Events, Policy & Ethics • Tags: , , , , , ,

UPDATED–The already complicated story behind the PREVAIL trial, which was designed to confirm the safety and efficacy of the Watchman left atrial appendage closure device, just got even more complicated. This morning, after the trial’s sponsor, Boston Scientific, prematurely distributed to investors a press release summarizing the results of the trial, the ACC announced that the scheduled presentation of the results at the main opening session of the meeting would not take place.

 

By way of background, last week the trial’s sponsor, Boston Scientific, first announced that the  principal investigator of the trial, David Holmes, would only “present the acute procedural safety results” from the trial. Then the company reversed itself two days later and announced that Holmes would present all three co-primary endpoints.

Holmes intended presentation this morning at the ACC in San Francisco makes clear why there was so much confusion. (The slides from his presentation have been made available to the media.) Although the trial results appear largely positive, the trial missed one of its three primary endpoints, and experts will likely spend a lot of time and energy trying to interpret the results.

Click here to read the full story on Forbes.

Stop Sign

 

 

 

ACC Prevails Upon Boston Scientific To Present More Data At Late Breaker Reply

by • Heart Rhythms, Interventional Cardiology & Surgery, People, Places & Events, Policy & Ethics

In an unusual reversal of a statement it made two days ago, Boston Scientific announced this afternoon that it would present all three co-primary endpoints of the PREVAIL clinical trial this Saturday at the American College of Cardiology scientific sessions in San Francisco. The PREVAIL trial, which was designed to confirm the safety and efficacy of the Watchman left atrial appendage closure device, is one of the most highly-anticipated late-breaking clinical trials at the ACC this year.

As reported here yesterday, earlier this week Boston Scientific said that the principal investigator of the trial, David Holmes, would only “present the acute procedural safety results.” This was a highly unusual development, since late-breaking clinical trial sessions are intended to provide the medical community with its first look at the main results of important clinical trials. By all accounts, the ACC was unhappy with the Boston Scientific announcement and initiated discussions with the company shortly after the announcement.

Click here to read the full story on Forbes.

 

FDA Issues Warning Letter To CoreValve Investigator Reply

by • Interventional Cardiology & Surgery, People, Places & Events, Policy & Ethics • Tags: , , , , , ,

The FDA has issued a warning letter to an investigator in the Medtronic CoreValve US Pivotal Trial. The letter cites numerous serious violations relating to the treatment of subjects in the trial testing the experimental Medtronic TAVI (transcatheter aortic valve implantation) device. The violations were uncovered during an FDA inspection last summer.

The subject of the FDA warning is Michael Ring, one of the two principal investigators of the CoreValve trial at the Providence Sacred Heart Medical Center site in Spokane, WA.

Click here to read the full story on Forbes. (Updated to include an additional comment from Dr. Ring.)

English: A warning sign with an exclamation mark

Are Most People With Complex Coronary Disease Getting The Best Treatment? 1

by • Interventional Cardiology & Surgery • Tags: , , , , , , ,

angiogram

The relative value of PCI (stents) and bypass surgery for the treatment of people with blocked coronary arteries has been a topic of intense interest and debate for more than a generation now. Over time, the less invasive and more patient-friendly (and less scary) PCI has become the more popular procedure, but the surgeons (who perform bypass surgery) and cardiologists (who perform the less invasive PCI) have argued furiously about which procedure is safest and will deliver the most benefit in specific patient populations. In general, the most complex cases require the more thorough revascularization provided by surgery, while the more simple cases do well with PCI and can therefore avoid the trauma of surgery. But the specific criteria have remained murky, and interventional cardiologists have aggressively sought to take on increasingly more complex cases.

Now, long term results from a highly influential trial comparing the two procedures offer what is likely the most definitive solution we are likely to have for a very long time. Five year results from the SYNTAX trial have now been published in the Lancet.

Here’s some of the perspective on this study from two very savvy cardiologists, Rick Lange and L. David Hillis. (These comments are extracted from their original publication in CardioExchange. Note that I work on CardioExchange, which is published by the New England Journal of Medicine.)

…The “bottom line” conclusions are:

  1. CABG should remain the standard of care for patients with complex lesions…
  2. For patients with 3-vessel disease considered to be less complex… PCI is an acceptable alternative.
  3. All the data from patients with complex multivessel CAD should be reviewed and discussed by a cardiac surgeon and an interventional cardiologist, after which consensus on optimal treatment can be reached.

But Lange and Hillis, while they seem to largely agree with the study findings, also cast doubt on whether most physicians are likely to pay attention to the study details. They wonder whether most hospitals actually live up to the standards in the study, which requires, for each patient, a review of each patient by the multidisciplinary heart team, and the calculation of a complex SYNTAX score to establish the precise degree of risk.

Okay, let’s be honest….

  1. In your hospital, in what percentage of patients with left main or 3 vessel CAD are all the data systematically reviewed and discussed by a “Heart Team”?
  2. Do you calculate SYNTAX on all patients with left main or 3 vessel disease, or do you usually just “guestimate” lesion complexity?

If Lange and Hillis’s suspicions are correct, many people with complex coronary lesions are not receiving the best possible care. Hmmm.

Small Study Explores Expanded Use For TAVI In Native Valve Aortic Regurgitation Reply

by • Interventional Cardiology & Surgery • Tags: , , , , ,

As transcatheter aortic valve implantation (TAVI) gains increasing acceptance, cardiologists and surgeons are exploring additional patient populations who may benefit from the procedure. A new paper in the Journal of the American College of Cardiology provides the first look at the use of TAVI in the small but important group of patients with pure, severe native aortic valve regurgitation (NAVR) who do not have aortic stenosis.

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The authors acknowledge that TAVI will likely be used sparingly in the NAVR population:

…although these results are encouraging for those patients who are truly ineligible for surgery, surgical valve replacement remains the gold standard for those who can undergo it, even at high risk. Furthermore, there is an increasing number of patients in whom the native aortic valve can be preserved during surgery.

Click here to read the full story on Forbes.

400 Patients Sue Kentucky Hospital and 11 Cardiologists Over Unnecessary Procedures Reply

by • Interventional Cardiology & Surgery, Policy & Ethics • Tags: , , , , , ,

After undergoing more than two dozen cardiac procedures over a period of twenty years at St. Joseph Hospital in London, Kentucky, a patient was told by an outside cardiologist in Lexington that a recent procedure had been performed unnecessarily on an artery that was barely blocked.

“I would have not carried out this procedure,” the cardiologist, Michael R. Jones, wrote in a letter to the patient. The story is recounted  in an article published on Sunday in USA Today and the Louisville Courier-Journal, about the latest and perhaps the biggest case yet to surface over unnecessary cardiac procedures.

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Comment: By sheer coincidence, on the same day, the New York Times published a news analysis by Barry Meier about the scandal over Johnson & Johnson’s hip implant. “Doctors Who Don’t Speak Out” focuses on the failure of physicians to report problems with devices and drugs, but clearly the issue has even larger implications. A quote from Harlan Krumholz in the story– “Questioning the status quo in medicine is not easy”– could easily apply to the many recent cases of egregious overuse of cardiac procedures and devices. Imagine how recent history might have been different if colleagues of  Sandesh Patil and Mark Midei had raised earlier questions about borderline procedures. Cardiologists and other physicians complain about the intrusive and burdensome role played by the legal system, regulators, and insurance companies, but they have only themselves to blame if they refuse to police their own ranks, and indeed tacitly participate in a system that provides lucrative compensation to high-volume proceduralists.

Click here to read the entire post on Forbes.

Kentucky

St. Jude Raises The Stakes In Renal Denervation With An Outcomes Study Reply

by • Interventional Cardiology & Surgery, Prevention, Epidemiology & Outcomes • Tags: ,

 

The already hot field of renal denervation for resistant hypertension just got a little hotter. With the announcement of a clinical trial powered to detect improvements in cardiovascular outcomes, St. Jude Medical has raised the stakes.

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“To date, the renal denervation studies that have been conducted only looked at reducing blood pressure in patients with uncontrolled or resistant hypertension,” said Michael Böhm, a principal investigator for the trial, in a St. Jude press release. “What we need to know is if this minimally invasive approach for treating hypertension also correlates to a reduction in major cardiac events such as heart attack, stroke and death, which are the primary risks for patients whose blood pressure is not well controlled.”

 Click here to read the entire post on Forbes.

St Jude EngligHTN Rendal Denervation System

St Jude EngligHTN Rendal Denervation System

 

ACC And STS Break New Ground To Test TAVR For Unapproved Uses Reply

by • Interventional Cardiology & Surgery • Tags: , , , , , , , , , ,

In a startling break with tradition, the American College of Cardiology and the Society of Thoracic Surgeons will manage and run their own clinical trials testing expanded uses for transcatheter aortic valve replacement (TAVR). The two medical groups have recently been granted an investigational device exemption (IDE) by the FDA for one such trial and hope to gain an IDE for at least two more trials. The news was first reported by The Gray Sheet (subscription required) on February 8.

The new development represents a significant enlargement of the TVT registry, already run by the ACC and STS, which tracks all TAVR usage in the US.

Click here to read the entire post on Forbes.

ACC STS TVT logo

Should Radial Artery Access Be The Default Choice For PCI? Reply

by • Interventional Cardiology & Surgery • Tags: , , , ,

Over on CardioExchange six cardiologists, from fellows to senior faculty, talk about whether radial artery access should be the “default choice for PCI:

Megan Coylewright, MD, MPH (interventional fellow, Mayo Clinic): …radial PCI should be a part of every interventionalist’s toolkit…

Micah Eimer, MD (cardiologist, Glenview, IL): The data are pretty convincing on the lower rate of complications, and my clinicial experience confirms that. Patients who have undergone both radial and femoral approaches consistently and strongly prefer the radial approach…

L. David Hillis, MD, (Chair, Department of Internal Medicine) and Richard Lange, MD (Professor, University of Texas Southwestern Medical School): As old dogs (admittedly late in learning new tricks), we’re a part of “Gen-S” (“S” for Sones)… In Texas, where everything is bigger and better, we don’t feel a need to abandon the femoral approach.

Click here to read the entire discussion on CardioExchange.

Large Study Finds Genetic Links To Aortic Valve Calcification Reply

by • Interventional Cardiology & Surgery, Prevention, Epidemiology & Outcomes • Tags: , , , , ,

A genetic component is believed to play an important role in valvular heart disease, but the specific genes involved have not been identified. Now an interntional group of researchers has identified genetic variations that increase the risk for valvular calcification.

In a paper published in the New England Journal of Medicine, members of the Cohorts for Heart and Aging Research in Genome Epidemiology (CHARGE) consortium report on their search for genes associated with aortic valve calcification and mitral annular calcification in several of study cohorts. They found one SNP, in a gene previously shown to be associated with lipoprotein(a) levels and the risk of coronary artery disease, to be significantly associated with a doubling of the risk for aortic-valve calcification. This finding was replicated in additional cohorts.

Click here to read the full story on Forbes.

Should Physicians Be Business Partners With Medical Device Salesmen? Reply

by • Heart Rhythms, Interventional Cardiology & Surgery, People, Places & Events, Policy & Ethics • Tags: , , , , ,

Should a Florida cardiologist co-own a business running frozen yogurt shops with a medical device salesman? That’s the question raised by reporter John Dorschner in a story posted by the Miami Herald yesterday:

 

“Mark Sabbota, a Hollywood cardiologist, regularly implants $5,000 pacemakers in patients at Memorial hospitals in South Broward — generating, last year alone, more than a half-million dollars in sales for a manufacturer called St. Jude Medical.

Sabbota, public records show, also happens to be partners with a St. Jude sales rep in two corporations that run frozen yogurt shops.”

 

Click here to read the full story on Forbes.

 

English: Yogurt, Yogurtland, Frozen Desserts

 

 

ESC Gives A Shot In the Arm To Radial Access For PCI Procedures: The New Default? Reply

by • Interventional Cardiology & Surgery • Tags: , ,

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 US interventional cardiologist thinks the “hard benefits” of radial access “are more controversial,” though he supports increased use of the newer approach.

Click here to read the full story on Forbes.

Renal Denervation: Delineating Its Uses, Misuses, and Possibilities Reply

by • Interventional Cardiology & Surgery, Prevention, Epidemiology & Outcomes • Tags: , ,

Over on CardioExchange, Murray Essler, the chief investigator of the  Symplicity HTN-2 trial, answers questions from John Ryan about renal denervation:

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.

Click here to read the entire CardioExchange interview.

Trials Of Niacin And Atrial Fibrillation Device Will Headline American College Of Cardiology Program Reply

by • Heart Failure, Heart Rhythms, Interventional Cardiology & Surgery, MI/ACS, People, Places & Events • Tags: , , , , ,

Two big trials will highlight this year’s American College of Cardiology 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. Second is  the detailed presentation of the controversial failed HPS2-THRIVE trial of extended-release niacin and laropiprant.

Read my complete story on Forbes, along with a list of the late-breakers. 

ACC.13 logo

 

Early Results: Antiplatelet Drug Cangrelor Appears Effective For PCI Reply

by • Interventional Cardiology & Surgery • Tags: , , , , ,

The experimental antiplatelet drug cangrelor was superior to traditional clopidogrel in reducing ischemic events at 48 hours in PCI patients, according to the Medicines Company, which is developing the drug. The company today announced positive results from the phase 3 CHAMPION PHOENIX trial, a randomized, double-blind study comparing intravenous cangrelor to oral clopidogrel in PCI patients. The primary endpoint was the composite of death, MI, revascularization and stent thrombosis at 48 hours.

Click here to read the full story on Forbes.

 

Are Cardiologists Worried About Being Accused Of Unnecessary PCI? 3

by • Interventional Cardiology & Surgery • Tags: , ,

In the last week two cases highlighted, yet again, the continuing shift in standards regarding PCI. In his interventional cardiology blog on CardioExchange, Rick Lange asks cardiologists: Could You Be Accused of Doing Unnecessary PCI?

“Public confidence is eroding as the number of reports of physician suspensions and monetary penalties for unnecessary PCIs grow. Accordingly, patients are questioning use of PCI, even when it is indicated and advisable.”

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“Have investigations into unnecessary stenting changed your interventional practice? How so?”

 

Ohio Hospital And Cardiology Group Pay $4.4 Million To Settle Charges Over Unnecessary PCIs 2

by • Interventional Cardiology & Surgery, Policy & Ethics • Tags: , , , , ,

In 2006, Reed Abelson in the New York Times reported that the PCI rate in Elyria, Ohio was four times the national average. Now, six-and-a-half years later, the local hospital and cardiology group have agreed to pay $4.4 million to settle US allegations “that the hospital and the physicians “performed angioplasty and stent placement procedures on patients who had heart disease but whose blood vessels were not sufficiently occluded to require the particular procedures at issue.”

The leader of the cardiology group defends its quality of care and says it “settled this matter so we can put it behind us and move forward.”

Read my complete story about this on Forbes.