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Background: The aim of this study was to assess safety, efficacy, and clinical outcome of the IrisFIT PFO Closure System (Lifetech Scientific) for transcatheter closure of patent foramen ovale (PFO) in patients with a history of... more
Background: The aim of this study was to assess safety, efficacy, and clinical outcome of the IrisFIT PFO Closure System (Lifetech Scientific) for transcatheter closure of patent foramen ovale (PFO) in patients with a history of cryptogenic stroke, transient ischemic attack (TIA), or peripheral embolization. Patients and methods: We report the results of 60 consecutive patients undergoing PFO closure with the IrisFIT occluder for secondary prevention of paradoxical embolization. All cases were analyzed for periprocedural and device-related adverse events up to 12 months after implantation. In addition, the patients were evaluated for complete defect closure with transesophageal echocardiography (TEE) after 1 month, 6 months, and (if indicated) 12 months. Mean patient age was 53 ± 14 years and 37 patients (62%) were males. All patients had a history of at least 1 cryptogenic stroke, TIA, or peripheral embolization. Results: Technical success was achieved in all 60 procedures. The mean procedure time was 28 ± 11 minutes. There were no periprocedural or device-related complications up to 12 months after the implant. Successful defect closure at 6 months post device implantation was achieved in 56 cases (93.3%). Within 12 months of follow-up, 2 patients had recurrent TIAs, both with complete PFO sealing at the last TEE prior to the event. Conclusion: The IrisFIT PFO Closure System can be used safely and with high technical success for secondary prevention of cryptogenic stroke or peripheral embolization.
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Carotid stenting has become a commonly used procedure for the treatment of carotid artery stenosis. Though equipment and techniques have improved tremendously over the recent 3 decades, complications do occur. It is important for carotid... more
Carotid stenting has become a commonly used procedure for the treatment of carotid artery stenosis. Though equipment and techniques have improved tremendously over the recent 3 decades, complications do occur. It is important for carotid operators to be familiar with potential complications and adverse events. In this article complications and adverse events of carotid stenting including those that are related to the vascular access site, vessel spasm, dissection, perforation, thrombotic occlusion and hemodynamic instability and arrhythmias are reviewed. In addition, management strategies are discussed.
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The purpose of this study is to determine feasibility, safety, and effectiveness of the... more
The purpose of this study is to determine feasibility, safety, and effectiveness of the "shape-the-sheath" method in left atrial appendage closure. LAA occlusion is often a difficult procedure, due to not just the learning curve but also the three-dimensional variable nature of the left atrial appendage. Multiple sheaths have been created for various takeoffs. The purpose of this article is to show the feasibility of the "shape-the-sheath" method in left atrial appendage closure. Ten consecutive patients undergoing LAA occlusion without the "shape-the-sheath" method were compared to 10 consecutive patients undergoing LAA occlusion with the "shape-the-sheath" method using the Amplatzer Cardiac Plug (ACP) system and the Amplatzer TorqVue 45 × 45 sheath. The "shape-the-sheath" method resulted in significant decreases in fluoroscopy time (7.2 ± 3.0 min vs. 13.7 ± 6.7 min, P < 0.05), number of partial recaptures (0% vs. 50%, P < 0.05), with a trend toward decrease in the number of complete recaptures (0 vs. 40%, P = 0.09) compared to conventional sheath use. Shaping-the-sheath is a simple, elegant way to help conform delivery systems to better access the LAA and ensure stable position. Further experience with this procedure optimization step is warranted. © 2015 Wiley Periodicals, Inc.
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The purpose of this study was to evaluate safety and efficacy of catheter-based occlusion of residual leaks after percutaneous closure of the left atrial appendage (LAA). All cases of LAA closure at our center were reviewed to identify... more
The purpose of this study was to evaluate safety and efficacy of catheter-based occlusion of residual leaks after percutaneous closure of the left atrial appendage (LAA). All cases of LAA closure at our center were reviewed to identify secondary interventions for residual leaks. Leaks with a width of more than 3 mm by transesophageal echocardiography (TEE) were considered relevant. In a case-specific approach, depending on the respective morphology of the defect, either an LAA occlusion device or an Amplatzer Vascular Plug was implanted under TEE and fluoroscopic guidance. Between June 2003 and December 2013, 12 patients underwent residual leak closure. All procedures were technically successful and without complications. In 10 cases (83%), complete sealing was confirmed at TEE follow-up. In 2 patients, minimal gaps (2-3 mm) persisted and anticoagulation was continued. None of the patients had strokes during the follow-up period. Percutaneous residual leak closure after attempted LAA occlusion can be done safely and with high procedural success rates. © 2015 Wiley Periodicals, Inc.
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BackgroundPatent foramen ovale (PFO) is associated with cryptogenic strokes and transient ischemic attacks (TIAs). This study examined the initial experience with a new PFO occluder, the Nit‐Occlud® PFO Occlusion Device.MethodsSixty‐three... more
BackgroundPatent foramen ovale (PFO) is associated with cryptogenic strokes and transient ischemic attacks (TIAs). This study examined the initial experience with a new PFO occluder, the Nit‐Occlud® PFO Occlusion Device.MethodsSixty‐three patients with history of cryptogenic stroke or TIA and PFO underwent percutaneous closure of the defect with the Nit‐Occlud® PFO Occlusion Device. The primary endpoint was successful implantation without recurrent event, device malfunction, embolization, or the need for a replacement device over 6 ± 2 weeks. All patients underwent transesophageal echocardiography (TEE) at 6‐weeks, and 42 patients had repeat TEE at 6‐months. Clinical follow‐up at 18.7 ± 7.4 months was also performed.ResultsThe device was successfully implanted in 62 (98.4%) patients with no relevant procedural complications. At 6‐week follow‐up, 60 (95.2%) patients met the primary endpoint. A residual shunt at rest and with Valsalva was noted in 8 (12.7%) and 31 (49.2%) patients respectively at 6‐week TEE. At 6‐months, 1 of 42 (2.4%) and 9 of 42 (21.4%) patients had a residual shunt at rest and with Valsava, respectively. At 18 months, 5/63 patients had recurrent events (3 TIAs, 2 strokes). No device‐related complications occurred. One patient developed atrial fibrillation.ConclusionIn patients with cryptogenic stroke or TIA and a PFO, the Nit‐Occlud® PFO Occlusion Device appears to be both a safe and effective means to occlude the PFO. It is associated with high procedural success and favorable rates of complete closure. © 2015 Wiley Periodicals, Inc.
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Cardiology, Surgery, Medicine, Germany, Stroke, and 15 moreHumans, Internal Medicine, Female, Feasibility Studies, Male, Atrial Fibrillation, Recurrence, Cardiac Catheterization, Middle Aged, Adult, Occlusion, prosthesis Design, SECONDARY PREVENTION, Patent Foramen Ovale, and Cardiovascular medicine and haematology
General anesthesia is known to be associated with an increased risk for complications, especially in elderly and multi-morbid patients, the primary target population of the MitraClip(®) technique. The aim is to assess whether general... more
General anesthesia is known to be associated with an increased risk for complications, especially in elderly and multi-morbid patients, the primary target population of the MitraClip(®) technique. The aim is to assess whether general anesthesia and even conscious sedation can be avoided during the MitraClip(®) procedure. A total of 91 consecutive patients who underwent MitraClip(®) implantation [median 77 years, (IQR 72-83), 40 % female] were retrospectively analyzed. The first 26 patients were treated in general anesthesia. Afterwards, local anesthesia was chosen as primary anesthetic approach. Altogether, 28 (31 %) patients received general anesthesia, local anesthesia was performed in 35 (38 %) patients with sedation and in 28 (31 %) patients without sedation. The respective patient groups were similar regarding their baseline characteristics. Procedural success (successful implantation of at least one clip and post-procedure MR grade ≤2) was achieved in 89 % with no difference between the groups (93 % in general anesthesia, 89 % in local anesthesia with sedation, 86 % in local anesthesia without sedation, p = ns). No difference regarding hospital complications was noted. Local anesthesia with and without sedation was associated with less necessity for ICU/IMC stay (100 % in general anesthesia, 14 % in local anesthesia with sedation, 14 % in local anesthesia without sedation; p < 0.0001). One-year estimated survival was not significantly different among the groups (63, 82 and 75 %; p = ns). Transcatheter mitral valve repair with the MitraClip(®) can be performed without general anesthesia and even without conscious sedation with similar procedural success and complication rates.
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The field of left atrial appendage closure is growing rapidly. A host of new companies have introduced new closure devices. The devices seek to improve intraprocedur al, short-term, and long-term outcomes. This chapter will describe four... more
The field of left atrial appendage closure is growing rapidly. A host of new companies have introduced new closure devices. The devices seek to improve intraprocedur al, short-term, and long-term outcomes. This chapter will describe four devices and their current stages of preclinical and clinical trial development.
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Surgery, Medicine, Humans, Female, Male, and 13 moreFollow-up studies, Aged, Cardiac Catheterization, Retrospective Studies, prosthesis Design, Leak, Transcatheter Aortic Valve Replacement Market, Valve replacement, Postoperative Complications, Reoperation, Aortic valve stenosis, Transcatheter Aortic Valve Replacement, and Cardiovascular medicine and haematology
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ABSTRACT
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Surgery, Treatment Outcome, Adolescent, Medicine, Prospective studies, and 15 moreHumans, Female, Male, Atrial Fibrillation, Young Adult, Aged, Cardiac Catheterization, Middle Aged, Adult, Time Factors, prosthesis Design, Clopidogrel, Patent Foramen Ovale, Cardiovascular medicine and haematology, and Thrombus
ObjectiveTo evaluate the safety of percutaneous left atrial appendage (LAA) closure with the Amplatzer Cardiac Plug (ACP) in patients with nonvalvular atrial fibrillation (AF) who are not eligible for oral anticoagulation with... more
ObjectiveTo evaluate the safety of percutaneous left atrial appendage (LAA) closure with the Amplatzer Cardiac Plug (ACP) in patients with nonvalvular atrial fibrillation (AF) who are not eligible for oral anticoagulation with warfarin.BackgroundAnticoagulation is the treatment of choice for prevention of strokes in patients with AF, but some patients have contraindications to anticoagulation.MethodsA total of 60 patients with a CHA2DS2‐VASc score of at least 1 and contraindications to warfarin who underwent percutaneous LAA closure with the ACP were included. Stroke risk assessment was performed with the CHADS2 and CHA2DS2‐VASc score and the bleeding risk was calculated with the HAS‐BLED‐score. Follow‐up included office visits, telephone inquiries, and mail contact.ResultsMean CHADS2‐, CHA2DS2‐VASc‐, and HAS‐BLED scores were 2.6 (± 1.4), 4.3 (± 1.7), and 3.3 (± 1.0), respectively. Twenty‐five percent had a history of previous bleeding without oral anticoagulation and 63.3% while receiving oral anticoagulation. In 36.7% other contraindications to warfarin were present. Procedural success was achieved in 95%. Mean follow‐up time was 1.8 (1.0–2.8) years. The estimated annual stroke risk based on the CHADS2‐score was 5.8%. The estimated annual bleeding risk on warfarin based on the HAS‐BLED score was 3.7%. During follow‐up, the annual incidence of stroke was 0%. Major bleeding complications occurred in 1.9% annually.ConclusionsPercutaneous LAA closure with the ACP in patients with contraindications to oral anticoagulation is safe. The stroke and bleeding risk after percutaneous LAA closure is lower than predicted by conventional risk scores. © 2013 Wiley Periodicals, Inc.
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Cardiology, Risk assessment, Medicine, Stroke, Humans, and 15 moreInternal Medicine, Male, Atrial Fibrillation, Anticoagulants, Risk factors, Clinical Sciences, Aged, Cardiac Catheterization, Time Factors, Retrospective Studies, Risk Factors, Risk Assessment, Hemorrhage, Equipment Design, and Cardiovascular medicine and haematology
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Surgery, Treatment Outcome, Adolescent, Medicine, Stroke, and 15 moreProspective studies, Humans, Female, Male, Young Adult, Risk factors, Clinical Sciences, Aged, Middle Aged, Adult, Risk Factors, SECONDARY PREVENTION, Patent Foramen Ovale, Paradoxical embolism, and Cardiovascular medicine and haematology
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Medicine and Denervation
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The objective of this trial is to investigate the effectiveness and safety of a new septal occluder with bioresorbable framework (Carag Bioresorbable Septal Occluder CBSO, CARAG AG, Switzerland) in the treatment of secundum ASD or PFO.... more
The objective of this trial is to investigate the effectiveness and safety of a new septal occluder with bioresorbable framework (Carag Bioresorbable Septal Occluder CBSO, CARAG AG, Switzerland) in the treatment of secundum ASD or PFO. Device closure of ASD/PFO is standard of care in most countries
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The blood pressure-lowering effect of percutaneous renal denervation (RDN) is controversial. The success of RDN may be device-dependent. We sought to compare the efficacy of RDN by chemical neurolysis using alcohol (Peregrine System... more
The blood pressure-lowering effect of percutaneous renal denervation (RDN) is controversial. The success of RDN may be device-dependent. We sought to compare the efficacy of RDN by chemical neurolysis using alcohol (Peregrine System Infusion Catheter; Ablative Solutions, Inc., Menlo Park, CA, USA) to RDN by radiofrequency (RF) ablation with the single-electrode RF catheter (Symplicity Flex; Medtronic, Minneapolis, MN, USA) in a porcine model. This was a prospective, randomised, blinded study. Pigs were assigned to undergo bilateral RF ablation or chemical neurolysis. Primary endpoints were ablation depth and renal tissue norepinephrine (NE) concentrations at three-month follow-up. Twelve pigs underwent RF ablation (n=4) or chemical neurolysis by infusion of 0.3 mL (n=4) or 0.6 mL (n=4) alcohol. Ninety days after RF ablation and chemical neurolysis with 0.3 mL and 0.6 mL of alcohol, mean maximal tissue injury depth was 3.9±1.2 mm, 6.6±1.7 mm and 8.2±2.2 mm, respectively (p<0.001 for either dose of alcohol vs. RF ablation). Compared with historical controls, median renal tissue NE concentration reductions were 66%, 78% and 83% after RF ablation and chemical neurolysis using 0.3 mL and 0.6 mL alcohol, respectively (p=0.107 for chemical neurolysis vs. RF ablation). Mean total ablation area was significantly greater in both (0.3 mL and 0.6 mL) alcohol groups (p=0.0001 for both) than the RF ablation group (30.8±13.7 mm2, 41.6±12.4 mm2 and 11.0±7.5 mm2, respectively). RDN is more effective using chemical neurolysis than single-electrode RF ablation. Our findings suggest that the efficacy of RDN may be device-dependent.