EVACS 2012
EVACS 2012

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EVACS Newsletter August 2011

SCIENTIFIC NEWS

INDUSTRY NEWS


@ Scientific news

1. Combined percutaneous treatment of multivessel coronary artery disease and carotid artery disease compares favorable with previous surgical or hybrid revascularization options. From J Am Coll Cardio Interv at
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Educational Slide available to download.

A significant proportion of patients with multivessel coronary artery disease (CAD), candidate for either surgical or percutaneous revascularization, present with concomitant Carotid Artery Disease. Tomai F et al looked at the outcome of 239 patients (20.5% with carotid disease) treated with staged or simultaneous multivessel coronary PCI and carotid artery stenting (CAS). The primary endpoint was the incidence of major cardiac and cerebrovascular events, including any death, myocardial infarction, or stroke occurring between the first revascularization procedure and 30 days after treatment of the second vascular territory affected. The incidence of the primary endpoint at 30 days was 4.2% (95% confidence interval [CI]: 2.02 to 7.56). The rate of death, myocardial infarction, and stroke at long-term follow-up (median 520 days) was 4.2%, 2.1%, and 3.8%, respectively. At long-term follow-up, patients with previous cardiovascular disease had significantly higher rates of major cardiac and cerebrovascular events than did patients with a first clinical episode (17% vs. 6%, hazard ratio: 3.34; 95% CI: 1.46 to 7.63; p = 0.004). In patients with concomitant coronary and carotid artery disease, a simultaneous percutaneous approach may offer an attractive treatment option, especially for those patients who are at high surgical risk. J Am Coll Cardiol Intv, 2011; 4:560-568, doi:10.1016/j.jcin.2011.01.012

2. Results from the US Wingspan registry for PTA of symptomatic intracranial stenosis are announced.
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Educational Slide available to download.

Fiorella DJ et al reported ahead of publication the results of the US registry for PTA in symptomatic intracranial stenosis treated with the Gateway-Wingspan stenting system (Boston Scientific). During a 21-month study period, 158 patients with 168 intracranial atherostenotic lesions (50% to 99%) were treated with the Gateway-Wingspan system. Clinical and angiographic follow-up results were recorded for patients from 5 participating institutions. Primary end points were stroke or death within 30 days of the stenting procedure or ipsilateral stroke after 30 days. he average follow-up duration was 14.2 months with 143 patients having at least 3 months of clinical follow-up and 110 having at least 12 months. The cumulative rate of the primary end point was 15.7% for all patients and 13.9% for patients with high-grade (70% to 99%) stenosis. Of 13 ipsilateral strokes occurring after 30 days, 3 resulted in death. Of these strokes, 76.9% (10 of 13) occurred within the first 6 months of the stenting procedure and no events were recorded after 12 months. An additional 9 patients experienced ipsilateral transient ischemic attack after 30 days. Most post-procedural events (86%) could be attributed to interruption of antiplatelet medications (n=6), in-stent restenosis (n=12), or both (n=1). In 3 patients, the events were of uncertain etiology. The authors concluded that there is still a risk for stroke after successful PTA with the Wingspan stent system in patients treated with symptomatic intracranial stenosis. Importantly, most of these strokes were associated with in-stent restenosis and with interruption of antiplatelet therapy.

3. Results from the One year outcome of patients been undergone TAVI with Edwards-SAPIEN Aortic Bioprosthesis published ahead of print. The largest registry for transcatheter aortic valve implantation (TAVI) demonstrates excellent 1-year outcome.
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Educational Slide available to download.

The Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry was created after the encouraging results of the Cohort 1 registry, to observe the outcome of patients undergoing TAVI with the Edwards SAPIEN transcatheter aortic bioprosthesis system. Cohort 1 showed encouraging results for the 30-day outcome establishing the feasibility and acute success of the present treatment. In the current issue of Circulation, Thomas M et al present the 1-year outcome of those patients. 1038 patients, initially enrolled in the Cohort 1 at 32 experienced centers, were followed-up for 1 year. Patients with transapical approach (n=575) suffered more comorbidities than those treated with transfemoral approach (n=463), having a significantly higher logistic Euroscore (29.0% vs. 25.8%, p=0.007). High rates of survival were observed in both the transapical (TA) and transfemoral (TF) approach (TF = 72.1% for TA = 81.1%). Overall survival rates were 76.1%. Obviously, patients with higher Euroscore values suffered higher rates of mortality. Interestingly, the stroke rate after 30-days post-procedure remain low, indicating that elevated stroke rates observed in other TAVI studies, presumably regard a periprocedural complicatin. Careful device manipulation, catheter handling or even application of the modern cerebral protection devices, specifacally desinged for TAVI procedures (e.g Embrella Embolic Deflector™, Embrella Cardiovascular™, Wayne, PA) may result in significantly lower rates of periprocedural stroke rates and improve acute and long-term outcome of TAVI patients. Moreover, SOURCE registry announced better results for TA TAVI patients, having the same mortality rates as the historical TF TAVI patients.

4. Plaque composition may explain outcomes in older patients undergoing carotid artery stenting.
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Educational Slide available to download.

Though already known from the clinical practice, a significant proportion of patients treated with PCI for unprotected LM (UPLM) disease, present chronic total occlusion (CTO) of the RCA. The importance of this finding, has been underestimated. Recently, Migliorgini A et al, have looked at the outcome of patients who had been treated with PCI of UPLM having CTO of the RCA and compared with those who had no CTO of the RCA. They found that 6-month mortality and 3-year mortality is significantly increased in those UPLM PCI patients who had also CTO of the RCA. The authors conclude that presence of the should be considered as an important factor to be counted when considering PCI in UPLM.

@ Industry news

1. Boston Scientific announce the launch of a new PTA balloon catheter, suitable for wide range of peripheral procedures.

Boston Scientific Corporation announced the global launch of its Mustang™ PTA Balloon Catheter, a highly deliverable 0.035 inch percutaneous transluminal angioplasty (PTA) catheter designed for a wide range of peripheral angioplasty procedures. The Company plans to launch the product immediately in the U.S., Europe and other international markets. Boston Scientific developed the Mustang PTA Balloon Catheter to meet physician needs for a low-profile, high-pressure balloon catheter in a wide range of sizes.  It is the first to use Boston Scientific's NyBax™ Balloon Material, a proprietary co-extrusion of nylon and Pebax® polymers engineered to provide high-pressure, non-compliant dilatation in a low-profile balloon.  The Mustang Balloon Catheter offers excellent rated burst pressure (up to 24 atmospheres) and is the only 7 x 200 mm balloon compatible with a 5 French introducer sheath.  Available in 203 sizes, it provides the broadest matrix of any available peripheral balloon. "The Mustang Balloon Catheter offers a low tip profile and excellent deliverability to accommodate workhorse and complex lesions," said Joe Fitzgerald, Senior Vice President and President of Boston Scientific's Endovascular Unit. "Its versatility and extensive size matrix allow physicians to address nearly every peripheral need, ranging from treating blockages in femoral arteries to dialysis fistulae.  The Mustang Balloon Catheter demonstrates Boston Scientific's commitment to continuing its legacy as a pioneer and global leader in peripheral balloon angioplasty."


2. St. Jude Medical announced approval of the first system combining FFR and OCT capabilities

St. Jude Medical, Inc., a global medical device company, today announced it has received European CE Mark approval for its ILUMIEN(TM) system, the first integrated diagnostic technology that combines optical coherence tomography (OCT) and fractional flow reserve (FFR) technologies on one platform. The combined system offers physicians advanced physiological and anatomical insight to improve the diagnosis and treatment of coronary artery disease. The ILUMIEN system features the St. Jude Medical PressureWire(TM) Aeris, a wireless interventional tool that measures FFR to evaluate the severity of blood flow blockages in the coronary arteries, and the St. Jude Medical C7-XR(TM) OCT diagnostic imaging technology with Extreme Resolution(TM), a first-to-market intravascular imaging technology that allows physicians to visualize and measure important vessel characteristics otherwise not visible or difficult to assess with older intracoronary imaging technologies. Combined, the two technologies enable the optimization of percutaneous coronary intervention (PCI) by assisting physicians in identifying culprit lesions responsible for ischemia and by providing physicians with precise measurements of lesion dimensions and vessel size and structure. Additionally, the St. Jude Medical ILUMIEN system features the Wi-Box(TM), a wireless device that enables the ILUMIEN system to receive data (aortic pressure readings) from the catheterization lab wirelessly. The Wi-Box allows physicians and staff a completely cable-free FFR solution, combining the ease of use of a built-in system with the cost efficiency of a mobile platform. Complete evaluation of coronary lesions with both functional (FFR) and the imaging modalities (OCT) would allow cardiologist to treat the culprit lesions more accurately improving acute and long-term patients outcome. The C7-XR System with the C7 Dragonfly(TM) Imaging Catheter and the PressureWire Aeris were launched in Europe in 2009.

3. Medtronic’s Symplicity® Catheter gets approval to be tested in US for a clinical trail. Would Renal Denervation Catheter proved to be another option for treatment of resistant hypertension?

Food And Drug Administration has conditionally approved the protocol for SYMPLICITY HTN-3, the company's U.S. clinical trial of renal denervation with the Symplicity Catheter System for the treatment of resistant hypertension. Medtronic said FDA approval of the SYMPLICITY HTN-3 protocol enabled it to become the first company to conduct a randomized, controlled trial of renal denervation in the United States. The novel treatment approach is a catheter-based intervention for patients with resistant hypertension who have been unable to achieve target blood pressure levels despite multiple medications. Having received Europe's CE mark and a listing with Australia's Therapeutic Goods Administration, Medtronic's Symplicity Catheter System is commercially available in Europe and Australia. The Symplicity Catheter System is not approved by the FDA for U.S. commercial distribution. SYMPLICITY HTN-3 is a single-blind, randomized, controlled trial designed to evaluate the safety and effectiveness of renal denervation with the Symplicity Catheter System in patients with resistant hypertension. Across 60 U.S. medical centers, the study will enroll approximately 500 patients who will be randomized to receive either renal denervation and treatment with anti-hypertensive medications or treatment with anti-hypertensive medications alone.