- PREMIUM: Prospective Randomized investigation to Evaluate incidence of headache reduction in subjects with Migraine and PFO Using the AMPLATZER PFO Occluder compared to Medical Management.(US Steering Committee: Tobis J, Sorensen SG, Silberstein S, Charles A)
SUMMARY: Migraine headache is an often disabling disorder which has an association with high flow PFO. Many observational studies have reported dramatic improvement and even complete resolution of migraine headache after PFO closure. PREMIUM is a very rigorous study designed to prove whether PFO closure with an implantable device is a safe and effective treatment for migraine. Patients meeting IHS criteria for migraine, with 4-14 headache days per month, who have failed 2 medications, and have a high flow PFO will keep a 1 month diary and then be randomized to either catheter PFO closure or a diagnostic catheter procedure to define, but not close the PFO. Only through this double blind, randomized study( if positive) will this treatment become accepted by insurance companies and available to migraine sufferers. This will impact 15 million people in the US>
- SLEEP APNEA, STROKE AND PFO: Thomas, Maya, Sorensen SG, Raleigh L, Aguilar H
SUMMARY: Sleep apnea is a common disorder of sleep characterized by altered breathing, apnea, heart failure, and fatigue. Sleep apnea patents also have a 2-4 fold risk of stroke which cannot be accounted for by age, high blood pressure, high cholesterol, smoking, or diabetes. PFO seems to be more common in sleep apnea patients and trans-cranial Doppler (TCD) studies have shown increased right-to-left shunting during sleep apnea spells. This study uses contrast enhanced, quantitative power M-mode TCD to define the incidence and association of high flow PFO in sleep apnea patients who have low oxygen levels despite CPAP.
- PROTECT-AF TRIAL; A RANDOMIZED TRIAL OF THE WATCHMAN® DEVICE IN PATIENTS WITH HIGH RISK ATRIAL FIBRILLATION; Whisenant B (PI) Sorensen SG ( co-PI)
SUMMARY: Atrial fibrillation is a common rhythm disorder which causes a rapid, irregular heart rate. The major risk of atrial fibrillation is stroke and ½ of these strokes are disabling. Although Coumadin, a strong blood thinner reduces the risk of stroke by 60%, some patients remain at significant risk for recurrent stroke and risk of bleeding. Clots form in the atrial appendage in atrial fibrillation and surgical closure of the appendage has been performed for many years during other heart operations. This study compares the results of closure of the atrial appendage by a catheter delivered device which permanently occludes the appendage( thereby reducing the need for coumadin), versus life-long coumadin. (See our patient information page).
- PFO CLOSURE DURING PREGNANCY: Porter F, Sorensen SG
SUMMARY: Pregnancy is a hyper-coagulation state and stroke is associated with PFO during pregnancy and several months after delivery. This recently completed study evaluates the safety and efficacy of catheter PFO closure during pregnancy managed by high-risk obstetrical care.
- PREVALENCE AND CHARACTERISTICS OF MRI LESIONS IN HIGH LEVEL SHUNT PFO PATIENTS: Reichert W, Goldstein M, Thoen D, Halverson G, Podolsky, Sorensen SG.
SUMMARY: First stroke due to PFO is disabling in ½ of patients (Lausanne Study) and early definition of risk may help in preventing stroke. MRI lesions are 3 fold increased in migraine patients, possibly due to PFO raising the possibility of frequent micro-embolization due to PFO. This study uses contrast enhanced, quantitative TCD to prospectively evaluate the relationship between MRI abnormalities and high shunt. Preliminary evaluation of our data has demonstrated that 60% of patients with multiple MRI lesions have severe shunt on TCD.
- STROKE PREVENTION FOR LIVER TRANSPLANTATION: SAFETY AND EFFICACY OF PREVENTATIVE PFO CLOSURE BEFORE TRANSPLANTATION: Sorensen SG, Box T,
SUMMARY: Liver transplantation in infants has a high risk of stroke due to Presence of a PFO in all infants < 12-18 months of age. This risk is related also to the large amount of material released from the transplanted organ and the need for IVC cross-clamping. This study (in preparation) reports our combined experience in 20 patients undergoing PFO closure for stroke prevention in this setting. This study also provides insight into pulmonary transit of bubbles in liver patients which applies to other situations.
- ERRORS OF PFO DIAGNOSIS: DEFINING NORMAL PULMONARY BUBBLE CONDUCTANCE: Sorensen SG Barrclough R, Ketterer J, Turnbaugh T,
SUMMARY: One of the major causes of disagreement between physicians regarding PFO closure is due to the erroneous idea that any bubble appearance in the left atrium seen on echo (even 1 bubble) constitutes a PFO. Many early studies as well as 2 recent studies have found a low risk of stroke for PFO but most of these patients had no PFO or a tiny PFO. Our recently completed study of 50 patients evaluated in the catheterization laboratory looked at the appearance of bubbles in the left atium seen on intra-cardiac echo (ICE) after bubble injection directly into the pulmonary artery using a catheter. This study demonstrates that moderate bubble conductance occurs in most patients. Normal bubble flow though the lungs is much higher in young patients, women, and in patients with liver disease. This study confirms the need to quantitate shunt flow and it explains the problems with previous research.
- WHAT IS THE BEST CLOSURE DEVICE FOR LARGE PFO? LOWER SHUNT RATES BY QUANTITATIVE TCD FOR THE AMPLATZER SO DEVICE VS AMPLATZER PFO DEVICE: Sorensen SG, McKnight Wes
SUMMARY: We compared the results of quantitative power M-mode Transcranial Doppler (TCD) before and 3months after PFO closure using the 35 mm Amplatzer® PFO device ( a central pin device designed for PFO closure) and the Amplatzer® SO device (a central occluding device designed for closure of atrial septal defects =ASD). 58 patients with recurrent stroke received the 35 mm central pin device as the 25 mm device was too small and actually prolapsed and was removed first in 10 patients. 56 patients were treated with SO devices ≥ 13 mm and 203 patients were treated with a 12 mm SO device. Residual shunting was significantly lower at three months for the ≥ 13 mm SO group compared with the 35 mm PFO group ( TCD 2.2 vs TCD 3.1 ; p=0.1). If the 35 mm PFO device was compare to SO device ≥ 12 similar results were found ( TCD 1.8 vs 3.1; p= 0.0001). Since only large PFO are closed in our program, the SO device seems more favorable since implant and 90 day safety results are the same.
- Use of the Amplazer® SO ASD closure device for closure of large PFO; Safety and efficacy in 560 patients: Sorensen SG, Barraclough R, Ketterer J, Turnbaugh T, Raleigh L, Aguilar H
SUMMARY: Autopsy defined PFO size is 3-4 mm. Recent and previous studies have demonstrated low risk for stroke for small shunt / size PFO but high risk of recurrent stroke for large PFO. Large PFO have features for closure which more closely parallel ASD characteristics. This study reports a large experience using the ASD SO closure device with an excellent safety record: ( death=0, perforation = 0, tamponade = 0, stroke = 0, bleed = 0, device embolization = 0, device thrombus =0, device infection = 0) 1 device removed for concern re erosion in marathon runner. 3 month residual shunt by TCD 1.5 (vs 1.86 for PFO central pin device. The Amplatzer® SO device is safe for PFO closure, particularly for large defects and ay be superior in reducing residual shunt.
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