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    <recommendedItem id="20100101_19_457"
                     title="Long-Term Safety of Drug-Eluting Stents Affirmed (CME/CE)"
                     score="0.015"
                     href="http://www.medpagetoday.com/Cardiology/Atherosclerosis/tb/18374?impressionId=1265742752108"
                     
      &lt;p&gt;Using sirolimus-eluting stents for the treatment of in-stent restenosis appears safe and effective over four years of follow-up, a study of an Italian registry showed.&lt;/p&gt;
&lt;p&gt;Through four years, there were low rates of target lesion revascularization (11.1%) and stent thrombosis (2.8%), according to Francesco Liistro, MD, of San Donato Hospital in Arezzo, Italy, and colleagues.&lt;/p&gt;
&lt;p&gt;About one in 10 patients (9.8%) died, and 3.2% had a nonfatal myocardial infarction.&lt;/p&gt;
&lt;p&gt;Survival free from a major adverse cardiac event was 80.3% at the end of follow-up, the researchers reported in the Feb. 16 issue of the&lt;em&gt; Journal of the American College of Cardiology&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Although drug-eluting stents have been shown to be safe and better than balloon angioplasty and vascular brachytherapy for in-stent restenosis in the short term, most previous studies have had limited follow-up.&lt;/p&gt;
&lt;p&gt;Reports of late stent thrombosis following implantation with drug-eluting stents have raised some concern about the long-term safety of these devices in unselected patient groups, according to Liistro and his colleagues.&lt;/p&gt;
&lt;p&gt;To explore the issue, the researchers turned to the Tuscany Registry of Unselected In-Stent Restenosis (TRUE), a prospective, two-center registry.&lt;/p&gt;
&lt;p&gt;All 244 patients included in the analysis underwent antiplatelet therapy with aspirin and either ticlopidine or clopidogrel (Plavix) for at least six months after the sirolimus-eluting stent was implanted.&lt;/p&gt;
&lt;p&gt;An earlier, nine-month analysis of this registry showed safety and effectiveness for the stent. This study confirmed the benefits through four years.&lt;/p&gt;
&lt;p&gt;Of 24 recorded deaths, 11 were from cardiac causes.&lt;/p&gt;
&lt;p&gt;Definite stent thrombosis occurred in five patients, four of whom had stopped taking clopidogrel more than a month before the event.&lt;/p&gt;
&lt;p&gt;Another two patients who were taking aspirin and clopidogrel had probable stent thrombosis.&lt;/p&gt;
&lt;p&gt;Patients who had diabetes were significantly more likely to have target lesion revascularization (OR 0.32, 95% CI 0.14 to 0.71) and major adverse cardiac events (OR 0.38, 95% CI 0.20 to 0.71) through four years.&lt;/p&gt;
&lt;p&gt;A left ventricular ejection fraction less than 50% was associated with higher odds of major adverse cardiac events (OR 0.32, 95% CI 0.13 to 0.80), as was creatinine greater than 1.5 mg/dL (OR 0.23, 95% CI 0.11 to 0.48).&lt;/p&gt;
&lt;p&gt;And patients with peripheral or carotid arterial disease were more likely to need target lesion revascularization (OR 0.35, 95% CI 0.14 to 0.88).&lt;/p&gt;
&lt;p&gt;The authors noted that the registry study was limited by the lack of valid control groups.&lt;/p&gt;
&lt;p&gt;In addition, in patients with a late occurrence of target lesion revascularization, the researchers could not determine whether a stenotic lesion inside the stented segment was a new atherosclerotic lesion or a restenosis.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The authors did not make any financial disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_278"
                     title="FDA Okays First Percutaneous Heart Valve"
                     score="0.005"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18135?impressionId=1265742752108"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has approved the Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, the first heart valve designed for implantation through a catheter in a leg vein.&lt;/p&gt;
&lt;p&gt;The device gives congenital heart defect patients with poorly functioning pulmonary valve conduits new treatment options without requiring open heart surgery.&lt;/p&gt;
&lt;p&gt;The valve does not cure the condition and may wear to the point of needing replacement over time, but a tissue valve in the device maintains proper blood flow-direction, which allows the valve to function longer than usual, an FDA statement said.&lt;/p&gt;
&lt;p&gt;Approval was based on clinical studies of 99 U.S. patients and 68 European patients.&lt;/p&gt;
&lt;p&gt;Participants showed improved heart function, and a majority noted improvements in clinical symptoms, the statement said.&lt;/p&gt;
&lt;p&gt;The limited durability of the device was similar to other existing treatments in the trial, with 21% of U.S. patients experiencing a stent fracture, the release said.&lt;/p&gt;
&lt;p&gt;Device manufacturer Medtronic must complete two postapproval studies to test long-term risks and benefits, including one study with 150 participants from the original clinical trials and more than 100 additional patients, who will each undergo a five-year evaluation.&lt;/p&gt;
&lt;p&gt;An additional condition of the device&apos;s approval is a review of healthcare professional specialization required for device implantation. The manufacturer must also maintain a database of valve recipients.&lt;/p&gt;
&lt;p&gt;The transcatheter valve was approved under the Humanitarian Device Exception (HDE) program, which supports device development for conditions affecting fewer than 4,000 people and allows approval for limited use with reasonable assurances that the device health benefit outweighs risk of injury or illness.&lt;/p&gt;
&lt;p&gt;Products with HDE approval can only be used at medical institutions under an institutional review board and cannot be sold for more than the cost of research, development, fabrication, and distribution.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_232"
                     title="FDA Gives Approval to New Heart Device"
                     score="0.001"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18089?impressionId=1265742752108"
                     
      &lt;p&gt;WASHINGTON -- The FDA has granted premarket approval to a second left ventricular assist system (HeartMate II).&lt;/p&gt;
&lt;p&gt;The device can now be used as destination cardiac support for patients with advanced-stage heart failure who are ineligible for transplantation. It was previously approved as an interim device for those awaiting transplantation.&lt;/p&gt;
&lt;p&gt;The approval was based on data from a two-year cohort study of 200, which randomized patients to the HeartMate II or the HeartMate XVE, the only other device approved for destination therapy, on a two-to-one basis, according to a statement from the device manufacturer Thoratec.&lt;/p&gt;
&lt;p&gt;Endpoints included survival at two years, free of debilitating stroke, and reoperation to repair or replace the device. The new device showed a 58% versus 24% two-year survival rate. Patients also experienced shorter hospital stays, lower rates of rehospitalization, and fewer reoperations annually.&lt;/p&gt;
&lt;p&gt;Patients with the HeartMate II noted an 80% increase in quality of life based on a 0% baseline, the release said.&lt;/p&gt;
&lt;p&gt;The device showed a lower rate of infection, renal failure, right heart and respiratory failure, and cardiovascular arrhythmia than its predecessor.&lt;/p&gt;
&lt;p&gt;As part of the premarket approval, Thoratec must complete a postmarket study and measure adverse effects, functional status, and quality-of-life data.&lt;/p&gt;
&lt;p&gt;The company also agreed to a second study to gather data on the relationship between bleeding, thrombosis, von Willebrand syndrome, and anticoagulation in left ventricular assist system patients.&lt;/p&gt;
&lt;p&gt;&quot;What this approval does do for the field of engineered solutions to healthcare problems is perhaps the most important aspect of this outcome. Innovation and improvements in technology continue to be made, and I am convinced that even better designs are on the horizon,&quot; Robert L. Kormos, MD, director of the Artificial Heart Program at McGowan Institute for Regenerative Medicine, said.&lt;/p&gt;
&lt;p&gt;The small size of the device allows it to be implanted in smaller patients, including many women.&lt;/p&gt;
&lt;p&gt;The device originally received premarket approval as the second bridge-to-transplantation device, after the HeartMate XVE, in 2008.&lt;/p&gt;
&lt;p&gt;Thoratec is located in Pleasanton, Ca.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_231"
                     title="FDA Adds Cardio Warnings to Weight-Loss Drug"
                     score="0.001"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18088?impressionId=1265742752108"
                     
      &lt;p&gt;WASHINGTON  --  The FDA said the weight-loss drug sibutramine (Meridia) should not be taken by patients with history of cardiovascular disease following a review of additional data showing an increased risk of heart attack and stroke among that population.&lt;/p&gt;
&lt;p&gt;The agency said the manufacturer, Abbott, has agreed to add the contraindication to its labeling, which will be expanded to include patients with a history of the following: &lt;ul&gt; &lt;li&gt;Coronary artery disease (i.e., heart attack, angina)&lt;/li&gt; &lt;li&gt;Stroke or transient ischemic attack&lt;/li&gt; &lt;li&gt;Heart arrhythmia&lt;/li&gt; &lt;li&gt;Congestive heart failure&lt;/li&gt; &lt;li&gt;Peripheral arterial disease&lt;/li&gt; &lt;li&gt;Uncontrolled hypertension (&amp;gt;145/90 mmHg)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The initial review of sibutramine began in November 2009 when the FDA received preliminary data from the SCOUT study suggesting patients using the drug had a higher risk for cardiovascular events. (See &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/17147&quot; mce_href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/17147&quot; target=&quot;_blank&quot;&gt;Early Data Link Diet Drug to MI, Stroke, and Cardiac Death&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;Prior to review, the product label included a warning for patients with cardiovascular disease.&lt;/p&gt;
&lt;p&gt;Healthcare professionals should monitor patients for increase in blood pressure and heart rate and should discontinue therapy if either increase is observed, an FDA statement said.&lt;/p&gt;
&lt;p&gt;Patients should also discontinue use of sibutramine if they do not lose 5% of their baseline body weight within the first three to six months of treatment, as the drug may not be effective and puts the patient at unnecessary risk, the release said.&lt;/p&gt;
&lt;p&gt;The FDA said its review of SCOUT study data, as well as other information related to the drug&apos;s risks and benefits, is ongoing and will be followed by an open public advisory committee meeting to determine if it requires additional regulatory action.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20090101_5_404"
                     title="FDA Wants Longer Studies and Harder Endpoints for Drug-Eluting Stent Approvals"
                     score="-0.005"
                     href="