Baptist Cardiac and Vascular Institute

Sun City Center, FL, United States

Baptist Cardiac and Vascular Institute

Sun City Center, FL, United States

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Rosenfield K.,Massachusetts General Hospital | Jaff M.R.,Massachusetts General Hospital | White C.J.,Ochsner Medical Center | Rocha-Singh K.,Prairie Heart Institute At St Johns Hospital | And 11 more authors.
New England Journal of Medicine | Year: 2015

BACKGROUND The treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis. Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery, potentially improving vessel patency by reducing restenosis. METHODS In this single-blind, randomized trial conducted at 54 sites, we assigned, in a 2:1 ratio, 476 patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions to angioplasty with a paclitaxel-coated balloon or to standard angioplasty. The primary efficacy end point was primary patency of the target lesion at 12 months (defined as freedom from binary restenosis or from the need for target-lesion revascularization). The primary safety end point was a composite of freedom from perioperative death from any cause and freedom at 12 months from limb-related death (i.e., death from a medical complication related to a limb), amputation, and reintervention. RESULTS The two groups were well matched at baseline; 42.9% of the patients had diabetes, and 34.7% were current smokers. At 12 months, the rate of primary patency among patients who had undergone angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty (65.2% vs. 52.6%, P = 0.02). The proportion of patients free from primary safety events was 83.9% with the drug-coated balloon and 79.0% with standard angioplasty (P = 0.005 for noninferiority). There were no significant between-group differences in functional outcomes or in the rates of death, amputation, thrombosis, or reintervention. CONCLUSIONS Among patients with symptomatic femoropopliteal peripheral artery disease, percutaneous transluminal angioplasty with a paclitaxel-coated balloon resulted in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a standard balloon. The drug-coated balloon was noninferior to the standard balloon with respect to safety. Copyright © 2015 Massachusetts Medical Society.


Bhatt D.L.,Harvard University | Kandzari D.E.,Piedmont Heart Institute | O'Neill W.W.,Ford Motor Company | D'Agostino R.,Boston University | And 13 more authors.
New England Journal of Medicine | Year: 2014

BACKGROUND: Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension. METHODS: We designed a prospective, single-blind, randomized, sham-controlled trial. Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure. Before randomization, patients were receiving a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs, including a diuretic. The primary efficacy end point was the change in office systolic blood pressure at 6 months; a secondary efficacy end point was the change in mean 24-hour ambulatory systolic blood pressure. The primary safety end point was a composite of death, end-stage renal disease, embolic events resulting in end-organ damage, renovascular complications, or hypertensive crisis at 1 month or new renal-artery stenosis of more than 70% at 6 months. RESULTS: A total of 535 patients underwent randomization. The mean (±SD) change in systolic blood pressure at 6 months was -14.13±23.93 mm Hg in the denervation group as compared with -11.74±25.94 mm Hg in the sham-procedure group (P<0.001 for both comparisons of the change from baseline), for a difference of -2.39 mm Hg (95% confidence interval [CI], -6.89 to 2.12; P = 0.26 for superiority with a margin of 5 mm Hg). The change in 24-hour ambulatory systolic blood pressure was -6.75±15.11 mm Hg in the denervation group and -4.79±17.25 mm Hg in the sham-procedure group, for a difference of -1.96 mm Hg (95% CI, -4.97 to 1.06; P = 0.98 for superiority with a margin of 2 mm Hg). There were no significant differences in safety between the two groups. CONCLUSIONS: This blinded trial did not show a significant reduction of systolic blood pressure in patients with resistant hypertension 6 months after renal-artery denervation as compared with a sham control. Copyright © 2014 Massachusetts Medical Society.


Bakris G.L.,University of Chicago | Townsend R.R.,University of Pennsylvania | Flack J.M.,Wayne State University | Brar S.,Medtronic | And 12 more authors.
Journal of the American College of Cardiology | Year: 2015

BACKGROUND Results of the SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial confirmed the safety but not the efficacy of renal denervation for treatment-resistant hypertension at 6 months post procedure. OBJECTIVES This study sought to analyze the 12-month SYMPLICITY HTN-3 results for the original denervation group, the sham subjects who underwent denervation after the 6-month endpoint (crossover group), and the sham subjects who did not undergo denervation after 6 months (non-crossover group). METHODS Eligible subjects were randomized 2:1 to denervation or sham procedure. Subjects were unblinded to their treatment group after the 6-month primary endpoint was ascertained; subjects in the sham group meeting eligibility requirements could undergo denervation. Change in blood pressure (BP) at 12 months post randomization (6 months for crossover subjects) was analyzed. RESULTS The 12-month follow-up was available for 319 of 361 denervation subjects and 48 of 101 non-crossover subjects; 6-month denervation follow-up was available for 93 of 101 crossover subjects. In denervation subjects, the 12-month office systolic BP (SBP) change was greater than that observed at 6 months (-15.5 ± 24.1 mm Hg vs. -18.9 ± 25.4 mm Hg, respectively; p = 0.025), but the 24-h SBP change was not significantly different at 12 months (p = 0.229). The non-crossover group office SBP decreased by -32.9 ± 28.1 mm Hg at 6 months, but this response regressed to -21.4 ± 19.9 mm Hg (p = 0.01) at 12 months, increasing to 11.5 ± 29.8 mm Hg. CONCLUSIONS These data support no further reduction in office or ambulatory BP after 1-year follow-up. Loss of BP reduction in the non-crossover group may reflect decreased medication adherence or other related factors. (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261). © 2015 by the American College of Cardiology Foundation.


Bakris G.L.,University of Chicago | Townsend R.R.,University of Pennsylvania | Liu M.,Medtronic | Cohen S.A.,University of Pennsylvania | And 12 more authors.
Journal of the American College of Cardiology | Year: 2014

BACKGROUND Prior studies of catheter-based renal artery denervation have not systematically performed ambulatory blood pressure monitoring (ABPM) to assess the efficacy of the procedure. OBJECTIVES SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) was a prospective, blinded, randomized, sham-controlled trial. The current analysis details the effect of renal denervation or a sham procedure on ABPM measurements 6 months post-randomization. METHODS Patients with resistant hypertension were randomized 2:1 to renal denervation or sham control. Patients were on a stable antihypertensive regimen including maximally tolerated doses of at least 3 drugs including a diuretic before randomization. The powered secondary efficacy endpoint was a change in mean 24-h ambulatory systolic blood pressure (SBP). Nondipper to dipper (nighttime blood pressure [BP] 10% to 20% lower than daytime BP) conversion was calculated at 6 months. RESULTS The 24-h ambulatory SBP changed -6.8 ± 15.1 mm Hg in the denervation group and -4.8 ± 17.3 mm Hg in the sham group: difference of -2.0 mm Hg (95% confidence interval [CI]: -5.0 to 1.1; p = 0.98 with a 2 mm Hg superiority margin). The daytime ambulatory SBP change difference between groups was -1.1 (95% CI: -4.3 to 2.2; p = 0.52). The nocturnal ambulatory SBP change difference between groups was -3.3 (95 CI: -6.7 to 0.1; p = 0.06). The percent of nondippers converted to dippers was 21.2% in the denervation group and 15.0% in the sham group (95% CI: -3.8% to 16.2%; p = 0.30). Change in 24-h heart rate was -1.4 ± 7.4 in the denervation group and -1.3 ± 7.3 in the sham group; (95% CI: -1.5 to 1.4; p = 0.94). CONCLUSIONS This trial did not demonstrate a benefit of renal artery denervation on reduction in ambulatory BP in either the 24-h or day and night periods compared with sham (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261). © 2014 by the American College of Cardiology Foundation.


Dabus G.,Baptist Cardiac and Vascular Institute | Linfante I.,Baptist Cardiac and Vascular Institute | Martinez-Galdamez M.,Hospital Clinico Universitario Of Valladolid
Clinical Neurology and Neurosurgery | Year: 2014

Objective We report our results of our experience using transarterial balloon-assisted embolization of aggressive DAVFs using a dual lumen balloon microcatheter. The advantages and disadvantages of this technique when compared to different Onyx embolization techniques are discussed. Patients and methods All patients with aggressive DAVFs who were treated with Onyx using transarterial balloon-assisted technique with a dual lumen balloon microcatheter were included. Clinical presentation, location of DAVF, Borden type, dual lumen balloon microcatheter used, amount of Onyx used, Onyx injection duration, complications, immediate angiographic and follow up results were included in the analysis. Results Five patients fulfilled the selection criteria. Their ages ranged from 24 to 62 years old. In 4 cases the dual lumen balloon microcatheter was a Scepter-C 4 mm × 10 mm (Microvention, Tustin, CA); in the other patient the device used was an Ascent 4 mm × 10 mm (Codman, Raynham, MA). In all 5 patients the dual lumen balloon microcatheter was used with the objective to cure the lesion and it was successful in all 5 cases. There was no vessel injury, unwanted embolization, retained microcather, microcatheter rupture or cranial nerve deficits in our series. Our mean Onyx injection time was 6.4 min (range from 2 to 10 min). There were no procedural complications in our series. Four out of 5 patients had angiographic follow up demonstrating persistent angiographic cure (follow up mean 6 months - range 4-7 months). Conclusions Our experience in this small series of patients indicates that the use of dual lumen balloon microcatheters is safe and feasible, facilitating the use of Onyx for embolization of DAVFs. © 2013 Elsevier B.V.


Jaff M.R.,Massachusetts General Hospital | Katzen B.T.,Baptist Cardiac and Vascular Institute
Journal of Vascular and Interventional Radiology | Year: 2010

PURPOSE: To evaluate the 2-year outcomes of safety and effectiveness for iliac artery stent placement and examine the effects of placement in the common iliac artery (CIA) and external iliac artery (EIA), the degree of initial stenosis, and patient gender on success. MATERIALS AND METHODS: Zilver vascular stents (Cook Inc., Bloomington, Indiana) were placed in 151 consecutive patients whose iliac arteries remained stenotic after percutaneous transluminal angioplasty (PTA). Success at 2 years was determined by patency, ankle-brachial index (ABI) scores, and Walking Impairment Questionnaire (WIQ) scores. RESULTS: Patency, ABI measurements, and WIQ scores showed improvement at 2 years, compared with preprocedure measurements. Kaplan-Meier estimate of overall patency at 2 years was 90% (n = 117). Significant improvement in ABI and WIQ scores was seen at 2 years, compared with preprocedural values (P < .01). The 2-year overall success rate was 91%. The degree of initial stenosis, stent location, and patient gender did not affect the success of the Zilver stent (P = .65, P = .58, and P = .77). The Kaplan-Meier estimate of the probability of experiencing a major adverse event (MAE) related to the device or stent placement procedure by the 2-year follow-up was 2.7%. CONCLUSIONS: The Zilver vascular stent remains durable at 2 years in regard to safety and clinical effectiveness, and is effective in the CIA and EIA both in male and female patients. © 2010 SIR.


Dabus G.,Baptist Cardiac and Vascular Institute | Linfante I.,Baptist Cardiac and Vascular Institute
Techniques in Vascular and Interventional Radiology | Year: 2012

Acute ischemic stroke (AIS) is an important public health issue with major impact on not only patients and families but also on the society as well. Among patients who suffer from AIS, those who have the event due to large-vessel occlusion are thought to have the worse outcome. Because most of the effort in endovascular treatment of AIS is aimed toward this type of stroke, it is important to understand its natural history. The goal of this manuscript was to briefly discuss the natural history of AIS due to large-vessel occlusion based on recent literature. © 2012 Elsevier Inc.


Samaniego E.A.,Baptist Cardiac and Vascular Institute
Journal of neurointerventional surgery | Year: 2013

Postpartum cerebral angiopathy (PCA) is a rare vasoconstriction syndrome that can lead to severe disability and death. The pathophysiology of PCA is unknown. A case of a 39-year-old woman who developed PCA 3 days after twin delivery is reported. She presented with right hemiparesis, aphasia and lethargy. Imaging studies demonstrated severe segmental narrowing of multiple cerebral arteries comprising the anterior and posterior circulations. She continued to deteriorate despite induced hypertension, immunosuppression, intravenous magnesium and oral nimodipine. Intra-arterial administration of nicardipine on three consecutive occasions reversed the angiographic vasospasm and led to symptom resolution. Definite improvement occurred after a 5 day course of intravenous immunoglobulin (IVIg). The patient described in this report developed recalcitrant PCA-induced vasospasm which resolved with endovascular administration of nicardipine and immunotherapy with IVIg.


Dabus G.,Baptist Cardiac and Vascular Institute | Lin E.,Baptist Cardiac and Vascular Institute | Linfante I.,Baptist Cardiac and Vascular Institute
Journal of NeuroInterventional Surgery | Year: 2014

Objective To report our single center experience in the treatment of fusiform aneurysms involving the intracranial vertebral arteries using reconstructive endovascular techniques. Patients and methods The neurointerventional database of our institution was retrospectively reviewed from June 2010 to February 2013. Patients who underwent endovascular treatment of fusiform intracranial vertebral artery aneurysms using reconstructive techniques were included in the analysis. Clinical presentation, size, reconstructive technique used, procedural complication, and clinical and angiographic follow-ups were included in the analysis. Results Nine patients, aged 41.76 years (mean 54.8 years), were included. Mean angiographic diameter of unruptured aneurysms was 8.4 mm (range 4.14) while ruptured aneurysms averaged 6 mm (range 5.7 ). Two patients (two women) presented with acute subarachnoid hemorrhage (SAH). One patient with a large partially thrombosed aneurysm was treated with stent reconstruction requiring deployment of two stents (no coiling). There was one asymptomatic procedural complication (non-flow limiting cervical vertebral dissection). All patients had good clinical outcomes (modified Rankin Scale score of 0 or ≤1) including the two patients that presented with SAH (Hunt and Hess grades 2 and 3). There were no late hemorrhages at a mean clinical follow-up of 12 months (6.24 months). Eight patients had angiographic follow-up (6- 18 months, mean 10.5 months) and six demonstrated aneurysm occlusion with complete vessel reconstruction at the angiographic follow-up. Conclusions The use of reconstructive techniques in the endovascular treatment of unruptured fusiform intracranial vertebral artery aneurysms is feasible, safe, and effective in the mid term. In patients presenting with SAH, however, the safety and effectiveness of these techniques remain unclear.


Linfante I.,Baptist Cardiac and Vascular Institute | Samaniego E.A.,Baptist Cardiac and Vascular Institute | Geisbusch P.,Baptist Cardiac and Vascular Institute | Dabus G.,Baptist Cardiac and Vascular Institute
Stroke | Year: 2011

Background and Purpose-Vessel recanalization is a strong predictor of good outcome in acute ischemic strokes (AIS) secondary to large vessel occlusions. We report our single-center experience with self-expandable stents in the treatment of AIS. Methods-The stroke database of Baptist Cardiac and Vascular Institute in Miami was retrospectively reviewed from August of 2008 to September of 2010. All cases of AIS in which a self-expandable stents was deployed as acute endovascular intervention were included in the analysis. Criteria for intervention were the onset of neurological symptoms because of AIS, a National Institute of Health Stroke Scale score 4 at presentation, stroke attributable to a large vessel occlusion, and failure of arterial thrombolysis or mechanical thrombectomy or both. Good outcome was defined as a modified Rankin Scale score ≤2 at 1 month from hospital discharge. Results-Nineteen patients with AIS who underwent stenting were identified. Median National Institute of Health Stroke Scale score on admission was 19. Six Enterprise and 13 Wingspan stents were deployed. Recanalization was achieved in 95% occlusions (63% thrombolysis in myocardial infarction grade 3 and 32% thrombolysis in myocardial infarction grade 2). Good clinical outcome was achieved in 42%. No intraprocedural complications occurred and all stents were successfully deployed. Symptomatic intracerebral hemorrhage occurred in 3 (16%) patients, 2 of whom died. Conclusions-Use of self-expandable stents in AIS appears to be safe and may be considered when currently available thrombectomy devices and/or intraarterial thrombolysis fail. © 2011 American Heart Association. All rights reserved.

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