New Devices May Bring Improved Treatment To Stroke Patients Reply

A large new trial provides the first substantial evidence that new devices can improve the outcome of patients who have acute ischemic stroke. Earlier, less sophisticated versions of the devices had produced disappointing results in clinical trials. The previous trials may also have been hindered by long treatment delays and difficulties in recruiting suitable patients. The new devices are retrievable stents that extract blood clots from inside vessels.

MR CLEAN (The Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands), published in the New England Journal of Medicine today,  was designed to address the limitations of these previous trials. 500 patients with ischemic stroke were randomized to usual care or the addition of intraarterial treatment within 6 hours of symptom onset.

Click here to read the full post on Forbes.

 

New Drug From Isis Breaks Important Ground But Unlikely To Dent The Market Reply

The first important results with a new drug under development by Isis Pharmaceuticals may well have an enormous long term impact on our understanding of how blood flows through the body and how that same blood forms clots in response to damage and disease. But it appears unlikely that the new drug– an anticoagulant unlike anything else now available–  will have a major impact on the large and important anticoagulant market.

FXI-ASO, under development by Isis, is an antisense oligonucleotide that reduces the level of factor XI, a key component of the intrinsic (contact) coagulation pathway. All the currently available anticoagulants target the extrinsic (tissue factor) coagulation pathway.

Click here to read the full post on Forbes, including detailed perspectives by Sanjay Kaul and Ethan Weiss.

 

Big Study Looks At Length of Drug Treatment After Stent Implantation Reply

The advent of drug-eluting stents dramatically reduced the restenosis (reclogging) rate associated with bare-metal stents but prompted new concerns about the rare but potentially lethal complication of stent thrombosis (ST). Cardiologists have relied upon dual antiplatelet therapy to prevent ST but there has been considerable uncertainty and controversy about the ideal duration of therapy.

The Dual Antiplatelet Therapy (DAPT) trial was coordinated by the Harvard Clinical Research Institute as part of a large-scale collaboration with the FDA, stent manufacturers, and pharmaceutical companies…. The main results of the trial were presented on Sunday at the American Heart Association meeting in Chicago and published simultaneously in the New England Journal of Medicine.

Click here to read the full post on Forbes.

 

Nonobstructive Coronary Artery Disease Linked to Elevated Risk Reply

A large number of people who undergo elective coronary angiography are found to have nonobstructive coronary artery disease, and these patients have significantly increased risk for myocardial infarction and death, according to a retrospective study published in JAMA.

Click here to read the full post on Forbes.

 

 

Aortic Valve Surgery for Nonagenarians Reply

As people continue to live longer physicians are increasingly confronted with very elderly patients who have serious conditions that might benefit from surgery but who are at high risk for surgical complications. In a paper published in the Annals of Thoracic Surgerydoctors at the Mayo Clinic reviewed their experience with 59 patients age 90 or older who had severe aortic stenosis and underwent surgical (SAVR) or transcatheter aortic valve replacement (TAVR).

Click here to read the full post on Forbes.

 

First Drug-Coated Balloon Approved By FDA For Leg Blockages Reply

The FDA today announced that it had approved for use in the US the first drug-coated angioplasty balloon catheter to re-open blocked arteries in the thigh and knee (superficial femoral and popliteal arteries). The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) is manufactured by CR Bard and has been available in Europe since 2012.

Click here to read the full post on Forbes.

 

Novel Boston Scientific Device Headed For Another Rough FDA Panel Reply

On Wednesday Boston Scientific’s Watchman device will once again appear before the FDA’s Circulatory System Devices advisory panel.  The Watchman is a novel catheter-delivered left atrial appendage closure device which is intended to be used in place of chronic warfarin therapy to lower the risk of stroke in people with atrial fibrillation. It has been under development for more than a decade and its approval has twice been postponed by the FDA.  Briefing documents released ahead of Wednesday’s panel suggest that the third time may not be the charm for Watchman, though close FDA watchers believe the device may ultimately squeak through.

Click here to read the full post on Forbes.

 

Cardiology Group Withdraws ‘Choosing Wisely’ Recommendation Reply

In the end it wasn’t wisdom for the ages. The American College of Cardiology said today that it was withdrawing one of its five recommendations in the “Choosing Wisely” campaign.  In 2012 the ACC recommended that heart attack patients should have only their culprit artery unblocked. It said that patients and caregivers should question whether complete revascularization of all nonculprit lesions in heart attack patients should be performed.

The original recommendation was based on non-randomized studies suggesting that treating all significantly blocked vessels in heart attack patients could be harmful. “However,” the ACC now states, “over the last two years, new science has emerged showing potential improvements for some patients in their overall outcomes as a result of complete revascularization.”

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Fractional Flow Reserve Gains Support in Stable CAD and NSTEMI Reply

In recent years interventional cardiologists have started to use a new catheter technique, called fractional flow reserve (FFR), in an attempt to assess which blocked vessels might benefit from a stent. Two studies presented at the European Society of Cardiology meeting in Barcelona offered new support for FFR, which has been slowly but surely gaining traction in the interventional cardiology community.

Bernard De Bruyne presented 2-year results from the FAME 2 (Fractional flow reserve versus Angiography for Multivessel Evaluation 2) study (simultaneously published in the New England Journal of Medicine). FAME 2 was designed to find out whether PCI, with the help of FFR, can reduce the rate of hard endpoints in stable coronary artery disease compared to medical therapy. (FAME 2 was sponsored by St. Jude Medical, which makes  an FFR pressure wire. Another major player in the field is the Volcano Corporation.)

Click here to read the full post on Forbes.

 

Principal Investigator Of Suspended Cytori Stem Cell Trials Remains Hopeful Reply

Shares of Cytori Therapeutics took a big bit hit today after the company disclosed in a press release that it had suspended enrollment in its ATHENA and ATHENA II trials. This kind of news is never a good sign, but the   principal investigator of the trial tells me that he believes the current problems are surmountable and that the trials are still viable.

Click here to read the full post on Forbes.

 

Clot Busters For Stroke Gain More Support Reply

Although thrombolysis for ischemic stroke has been widely recognized as beneficial, its use has been limited because of concerns about its effects on patients treated after 3 hours, on older patients, and on patients with mild and with severe strokes. Now a new metaanalysis published in the Lancet offers evidence that the use of thrombolysis should be more aggressively pursued.

Click here to read the full post on Forbes.

 

 

Study Finds Flaws in New Treatment For Blood Clots Reply

In recent years, catheter-directed thrombolysis (CDT) has been added to the current standard of anticoagulation therapy in some patients with deep vein thrombosis (DVT). The hope was that CDT would help reduce the high rate of post-thrombotic syndrome (PTS), but now an observational study finds no benefits and some important disadvantages associated with CDT.

In a report published in JAMA Internal Medicine, Riyaz Bashir and colleagues analyzed data from more than 90,000 patients hospitalized for DVT, 3649 of whom received CDT plus anticoagulation.

Click here to read the full post on Forbes.

 

FDA Places Clinical Hold On Phase 3 Trial Of Novel Anticoagulant Reply

A highly promising novel anticoagulant system now appears to be in serious difficulty. Regado Biosciences announced today that the FDA had placed a “clinical hold” on patient enrollment and dosing in the REGULATE-PCI trial, which is testing the Revolixys anticoagulation system. Revolixys consists of the Factor IX inhibitor pegnivacogin and an agent, anivamersen, which reverses its anticoagulant effect.

REGULATE-PCI is a phase 3 trial comparing Revolixys to bivalirudin (Angiomax, The Medicines Company) in 13,000 patients undergoing PCI.

Click here to read the full post on Forbes.

 

 

 

Study Explores Expanded Use For Edwards’ And Medtronic’s New Heart Valves Reply

In the last few years transcatheter aortic valve replacements from Edwards Lifesciences and Medtronic have entered the marketplace and now offer an alternative to surgery for some patients. Now these valves are being considered for use in patients who have already undergone surgery but whose bioprosthetic valves have failed.

Although surgeons and patients increasingly prefer bioprosthetic valves to mechanical valves, the chief drawback to the bioprosthetic valves is that they may eventually deteriorate, which means that more and more physicians and patients will inevitably be faced with the dilemma of how best to treat degenerated valves. Although surgical reoperation is considered the best solution, many patients are too old and frail for surgery. Transcatheter aortic valve implantation (TAVI) has been proposed for use in this situation, though the risks and benefits have not as yet been well defined.

Now, a new study in JAMA provides information on 459 patients with failed bioprosthetic valves who underwent TAVI with either the Edwards Sapien device or the Medtronic Corevalve device.

Click here to read the full post on Forbes.

 

ESC Hot Lines: First Real Data On Promising Novartis Heart Failure Drug Reply

The first real details about the much-anticipated novel new heart failure drug from Novartis will kick off this year’s Hot Line sessions at the annual meeting of the European Society of Cardiology in Barcelona, Spain. The meeting runs from August 30 until September 3.

As I have previously reported, the PARADIGM-HF trial was stopped because of a highly statistically significant reduction in cardiovascular mortality in patients taking LCZ696 (a novel, first-in-class Angiotensin Receptor Neprilysin Inhibitor) instead of the current gold standard of treatment, an ACE inhibitor….

Here is the complete list of Hot Line trials:

Click here to read the full post on Forbes.

 

Study Offers Reassurance About Newer Drug-Eluting Stents Reply

Drug-eluting stents (DES) have been viewed as a great advance over earlier stents and balloon angioplasty because they result in many fewer cases of restenosis. But enthusiasm for the first generation of DES was somewhat curbed due to reports of late stent thrombosis (ST), a rare but very dangerous complication. Now findings from a large ongoing registry study provide some reassurance about the long-term safety of the new generation of drug-eluting stents in patients with heart attacks (STEMI). The results are published  in the Journal of the American College of Cardiology.

SCAAR (Swedish Coronary Angiography and Angioplasty Registry) investigators analyzed data from 34,000 primary PCI patients who received a bare-metal stent, an old-generation DES, or a new-generation DES.

Click here to read the full post on Forbes.

 

Yet Another Delay For Boston Scientific’s Watchman Device Reply

Boston Scientific hopes the third time will be the charm. The company disclosed on Tuesday yet another obstacle in the path to approval for its novel Watchman left atrial appendage closure device for the prevention of stroke in patients with atrial fibrillation. Although it has already been before two FDA advisory panels, the company said that it had been informed by the FDA that it will need to undergo yet another advisory panel before gaining approval.

Click here to read the full post on Forbes.

Watchman_2

 

FDA Approves Second Generation Heart Valve From Edwards Lifesciences Reply

The next phase of the burgeoning and rapidly maturing transcatheter aortic valve replacement (TAVR) market has begun. Edwards Lifesciences announced on Monday afternoon that the FDA had approved its second generation Sapien XT TAVR device  for the treatment of high-risk and inoperable patients suffering from severe symptomatic aortic stenosis (AS).

Click here to read the full post on Forbes.

 

Wide Range In Cancer Risk From Radiation In Children Undergoing Heart Surgery Reply

Children with heart disease are at increased risk for developing cancer later in life due to their exposure to radiation during imaging procedures. Since an ever-growing number of children with heart disease now reach adulthood, this may become an increasingly important public health issue.

A new study published in Circulation offers some reassurance in finding that for most children the increased risk is low or negligible. But for some children who undergo more complex procedures, the increased risk is significant.

Click here to read the entire story on Forbes.

 

 

 

Prescription Delay Following Stent Implantation Is a Common and Deadly Problem Reply

After receiving a stent, many patients delay or fail to fill their prescription for clopidogrel or another antiplatelet agent. Now, a study published in the Journal of the American Heart Association offers evidence that this problem is widespread and often leads to serious consequences.

Researchers analyzed data from all stent implantations performed in British Columbia from 2004 through 2006. In all, 15,629 stents were implanted: 3,599 patients received at least one drug-eluting stent (DES), and 12,030 received bare metal stents (BMS) alone. Nearly a third of the patients in each stent group did not fill their prescription within 3 days after leaving the hospital.

A delay of 3 or more days in filling a first prescription for clopidogrel after hospital discharge was associated with significant increases in the risk for death and readmission with MI at 2 years:

Click here to read the full post on Forbes.

 

The Walking Dead: Renal Denervation In Europe Just Can’t Be Stopped Reply

Earlier this year the only large, well-designed trial of renal denervation– the once highly-promising catheter-based technology that was widely expected to “cure” difficult cases of resistant hypertension– failed spectacularly. Many hypertension experts believe that ultimately the technique will prove to be beneficial, but after the failure of Simplicity HTN-3 it is clear that there’s a great deal of research that needs to be performed to find out just how– or if– this novel technology should be used.

In the US this does not present a problem. The FDA has not approved renal denervation so it can only be used in a research setting. But that is not the case in Europe, where the device is available due to lower standards for device approval.

Right now Europe’s largest interventional cardiology meeting, Euro PCR, is underway in Paris. Surprisingly– or perhaps not– renal denervation is still being heavily promoted in Europe. Here is the evidence: a series of tweets by @Jeddacath, an interventional cardiologist who trained at the Brigham & Women’s Hospital in Boston and who is attending the meeting.

Click here to read the full post on Forbes.

 

Walking Dead

Medtronic To Pay Over $1Billion To Settle Patent Litigation With Edwards Lifesciences Reply

After years of protracted and often bitter litigation in the US and abroad, Edwards Lifesciences and Medtronic today announced a broad resolution to all their patent disputes over transcatheter heart valves.

Medtronic will pay more than a billion dollars over the course of the agreement, which lasts until April 2022.

Click here to read the full post on Forbes.