 |
home 2012 edition registration sponsorship newsletter contact |
|
|
|
|
|
@ EVACS Newsletter November 2011@ Scientific news1. TAVI and surgical aortic valve replacement improve outcome in patients with severe aortic valve stenosis at high risk for surgical replacement, comparing to those treated conservatively. From J Am Coll Cardiol More >> Educational Slide available to download.1.1. Since July 2007, 442 patients with severe aortic valve stenosis (age: 81.7 ± 6.0 years) judged as high risk for surgical aortic replacement (Euroscore 22.3 ± 14.6) where treated with three different approaches: 78 patients were set to optimum medical treatment, 107 patients had undergone surgical aortic valve replacement and 257 patients had treated with TAVI. Baseline clinical characteristics were similar among patients allocated to MT and TAVI, whereas patients allocated to SAVR were younger (p < 0.001) and had a lower predicted peri-operative risk (p < 0.001). Transfemoral TAVR was performed with either the CoreValve Revalving System (Medtronic, Minneapolis, MN) or the Sapien valve, whereas only the Sapien prosthesis was used for transapical access. At 30 months post procedure, clinical outcomes including death and myocardial infarction were similar between patients treated with surgical aortic valve replacement and TAVI, but significantly lower than in patients allocated to medical therapy. Importantly, stroke rates were similar in all three treatment groups. On multivariable regression analysis, the only predictors of mortality at 30 months were medical treatment, older age (> 80 years), peripheral vascular disease, and atrial fibrillation at baseline. At 1 year follow-up, again similar percentage of TAVI and surgical patients were alive and being in NYHA class I or II (92.3% for surgical and 93.2% for TAVI patients, p= NS). Both groups, though, had presented with significantly better rates of functional class improvement comparing to those patients set to medical therapy. The study proved that apart from the survival benefit, patients treated with either surgical or transcatheter valve implantation experience significant improvement in their life’s quality. 2. Prosthesis-patient mismatch in patients undergoing trancatheter aortic valve implantation results in less favorable trans-valvular hemodynamics and limited regression of LV mass regression. From J Am Coll Cardiol More >>  Educational Slide available to download.Prosthesis-patient mismatch (PPM) is a well-known phenomenon noticed occasionally after surgical aortic valve replacement for severe aortic stenosis. Typically, in those cases the effective orifice area (EOA) of a normally functioning prosthesis is too small in relation to the patient’s body size. The presence of significant PPM has been associated with increased trans-valvular gradient - despite the normally functioning aortic prosthesis - and limited regression of LV hypertrophy. Data from a consecutive series of 165 patients treated with transcatheter aortic valve replacement (TAVI) in Leiden, Netherlands, and in Milan, Italy shed light in this issue for the first time. Among those patients, thirty were identified with PPM defined as aortic valve prosthesis EOA < 0.85 cm2/m2. Importantly, patients with PPM tend to have greater severity of aortic stenosis with lower indexed aortic valve area compared to those without PPM (0.35 ± 0.09 cm2/m2 vs. 0.40 ± 0.10 cm2/m2 , p=0.005). Patients with PPM showed significantly LV mass regression and smaller left atrium volume 6 months post-procedure. Moreover, LV filling pressure remained high, as this was estimated with the E’/e’ ratio, in TAVI patients presented with PPM. When LV diastolic function was analyzed according to the diastolic function grade, a higher proportion of patients with PPM showed improvement in LV diastolic function than those with PPM (47.4% vs. 10%, p<0.001). PPM appear to have an important impact on the clinical status of the patients. There was a significant proportion of patients with PPM who did not demonstrate an improvement in functional class status. However, no difference in terms of MACCE was noted between patients with PPM and without PPM. 3. Carotid artery stenting appears to have an important anti-hypertensive benefit comparing with carotid endarterectomy, a retrospective analysis of the ICSS trail shows. From Stroke Journal More >>  Educational Slide available to download.An important finding as regard the control of hypertension in patients treated with symptomatic carotid artery disease, was revealed from a retrospective analysis of the International Carotid Stenting Study (ICSS). Altinbas et al reported a significant benefit in terms of blood pressure control in patients treated with carotid artery stenting (CAS) comparing to those treated with carotid endarterectomy (CEA). Authors looked at the blood pressure management of more than 1500 patients participated in the ICSS study for at least one year post - procedure. It is known that CAS may cause significant reduction of the blood pressure due to prolonged stimulation of the carotid sinus leading to baroreceptor dysfunction. On the other hand, hypotension as well as hypertension was noted in patients undergoing CEA. In this analysis, both groups had no differences in their blood pressure at baseline. After 1 month post index procedure a significant reduction in the blood pressure values was measured in both groups. The reduction was more prominent in the CAS group comparing with CEA. However, this difference disappeared in long-term (1 year). This leaded to an important reduction in the number of the anti-hypertensive medications taken by the patients, particularly in those treated with CAS. Authors concluded that CAS procedure may have a positive effect on patients suffered with hypertension, but they also draw the attention to proper anti-hypertension management of those patients, suggesting that optimal control of blood pressure should be a primary goal to those patients. 4.1 Carotid artery stenting (CAS) in the setting of acute stroke due to atherosclerotic extracranial occlusion is relatively safe and beneficial when performed within 6 hours of symptom onset. From JACC More >>  Educational Slide available to download.Stroke caused by acute occlusion of the ICA is associated with a significant level of morbidity and mortality. For this type of lesion, treatment with standard intravenous thrombolysis alone leads to a good clinical outcome in only 17% of the cases, with a death rate as high as 55%. Recanalization of the occluded ICA can lead to an improvement in acute symptoms of stroke, prevent possible deterioration, and reduce long-term stroke risk. Dr. Papanagiotou from Homburg, Germany, retrospectively looked at the acute and short-term outcome of 22 patients presented at their institution with acute stroke related to acute atherosclerotic extracranial internal carotid artery (ICA) occlusion. All patients received percutaneous revascularization procedure, along with mechanical or pharmacological thrombolysis, when needed, within 6 hours of symptoms onset. In 18 of those patients, an additional intracranial occlusion at the level terminal of ICA or at the level of middle cerebral artery (MCA) was also noted after successful ICA revascularization. Intracranial occlusions were either treated with the Penumbra system or the Solitaire stent–based recanalization system, or a combination of mechanical recanalization and intra-arterial thrombolysis. Patients were followed-up for 90 days using the modified Rankin scale and the National Institute of Health Stroke Scale (NIHSS). Successful revascularization of extracranial ICA with acute stent implantation was achieved in 21 patients (95%). There was no acute stent thrombosis. After successful recanalization of the origin of the ICA, the intracranial recanalization with Thrombolysis In Myocardial Infarction flow grade 2/3 was achieved in 11 of the 18 patients (61%). The overall recanalization rate (extracranial and intracranial) was 14 of 22 patients (63%). Nine patients (41%) had a modified Rankin Scale score of 2 at 90 days. The mortality rate was 13.6% at 90 days. The authors concluded that carotid revascularization in patients presenting with acute stroke related to acute atherosclerotic occlusion of the extracranial ICA using percutaneous carotid stenting is feasible and safe. Moreover, it may be of some benefit when patients present within 6 hours of symptoms onset. 4.2 The concept of CAS in patients suffering from acute stroke related to acute occlusion of ICA is not new. Researchers from Mirano, Italy, leaded by Reimers B, had also retrospectively looked at the short- and long-term outcome of acute stroke patients treated with CAS More >> In this study, recanalization success was somewhat lower. However, in this study procedural success was defined only when intracranial TIMI 3 flow was achieved and clinical success only when successful restoration of blood flow was accompanied with significant neurological improvement (NIHSS reduction of at least 4 points). All these patients were followed-up for approximately 15 months demonstrating relatively favorable midterm outcome. @ Industry news1. Boston Scientific WATCHMAN® Left Atrial Appendage (LAA) Closure Device has been implanted in the first patients in Latin America.The novel device is designed for use in patients in atrial fibrillation who are at risk for stroke and are eligible for long-term oral anticoagulation therapy such as warfarin. The WATCHMAN LAA Closure Device is intended to prevent embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism in patients with non-valvular atrial fibrillation. The first patient implants were performed by Bernardo Caicedo, M.D., Interventional Cardiologist, at Angiografia de Occidente in Cali, Colombia.Atrial fibrillation, which affects approximately 15 million patients worldwide, is a disorder that disrupts the heart's ability to beat regularly and pump blood efficiently. Patients in atrial fibrillation are at greater risk for stroke due to the formation and migration of clots in the left atrial appendage. Anticoagulants such as warfarin have traditionally been the only therapy for reducing stroke risk in these patients. Boston Scientific's WATCHMAN device is intended to be an alternative to long-term anticoagulation. It is designed to close the LAA, thereby preventing clots within the appendage from being dislodged into the bloodstream. "I am excited to be part of the first patient implants of the WATCHMAN device in Latin America," said Dr. Caicedo. "The percutaneously delivered device promises to offer a safe and effective alternative for atrial fibrillation patients who cannot take long-term oral anticoagulants and have limited options to reduce their stroke risk. It incorporates a pre-loaded device that is both repositionable and retrievable to enhance its ease of use."The WATCHMAN Device is the most clinically studied product of its kind currently available. In the multi-center, randomized PROTECT AF clinical trial, it proved to be non-inferior to warfarin and demonstrated a 38 percent relative risk reduction for a combined measure of stroke, cardiovascular death and systemic embolism compared to long-term warfarin therapy in 800 patients. The study also showed a 29 percent relative risk reduction in all stroke and a 90 percent relative risk reduction in hemorrhagic stroke compared to warfarin. Nearly 1,800 patients have now been recruited in WATCHMAN clinical trials with more than 2,700 patient-years of follow-up. The WATCHMAN device is CE Marked and was commercialized outside the United States in 2009. "The WATCHMAN device has been well received in many CE Mark countries and we look forward to beginning commercial launch in select Latin American markets this quarter," said Hank Kucheman, Chief Executive Officer for Boston Scientific. "We are pleased to bring this technology to more customers and their patients worldwide."Boston Scientific is currently enrolling U.S. patients in the PREVAIL study, a confirmatory study designed to gain Food and Drug Administration approval. Enrollment is expected to be completed in the first quarter of 2012. In the U.S., the WATCHMAN device is an investigational device, limited by applicable law to investigational use and not available for sale. The device was developed by Atritech, which Boston Scientific acquired in March 2011. 2. Boston Scientific Corporation welcomed positive outcomes from the COBRA clinical trial, which evaluated post-dilation of nitinol stents using CryoPlasty® Therapy with the PolarCath™ Peripheral Dilatation System compared to stenting with conventional balloon angioplasty in patients with diabetes presenting with blockages of the superficial femoral artery (SFA). The trial was funded through an unrestricted grant from Boston Scientific.Results from the prospective, randomized, multi-center trial demonstrated a significant 47 percent relative reduction in binary restenosis rates for patients treated with nitinol self-expanding stents using post-dilation with the PolarCath System. The analysis was presented today during a late-breaking clinical trial session by Principal Investigator Subhash Banerjee, M.D., Chief, Division of Cardiology at VA North Texas Health Care and Associate Professor of Medicine at the University of Texas Southwestern Medical School in Dallas, at the Cardiovascular Research Foundation's annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco.The COBRA trial enrolled 76 patients with 90 SFA lesions who were randomized to CryoPlasty Therapy or conventional balloon angioplasty (CBA) for post-dilation of nitinol stents used to treat SFA blockages. Inclusion criteria included diabetes, severe claudication and SFA lesions requiring stents >5 mm in diameter and >60 mm in length. The primary endpoint is the rate of binary in-segment restenosis determined by duplex ultrasonography.Follow-up data have been completed on 41 lesions in the CryoPlasty group and 43 lesions in the CBA group. Results at 12 months showed that binary restenosis was significantly lower in the CryoPlasty group (29.3 percent versus 55.8 percent, p=0.01). The secondary endpoint of change in the ankle-brachial index (ABI) from baseline to 12 months showed significant improvement in the CryoPlasty group (0.59+0.21 to 0.77+0.30, p=0.004) compared to the CBA group (0.62+0.19 to 0.65+0.26, p=0.66). ABI is the ratio of blood pressure in the lower legs to blood pressure in the arms, which can indicate the presence of blocked peripheral arteries (a higher number indicates less peripheral blockage). Procedural success was achieved in 100 percent of procedures in the CryoPlasty group. |