Morillo C.A.,Hamilton Health Sciences |
Verma A.,Southlake Regional Health Center |
Connolly S.J.,Hamilton Health Sciences |
Kuck K.H.,Asklepios Klinik St Georg |
And 6 more authors.
JAMA - Journal of the American Medical Association | Year: 2014
IMPORTANCE: Atrial fibrillation (AF) is the most common rhythm disorder seen in clinical practice. Antiarrhythmic drugs are effective for reduction of recurrence in patients with symptomatic paroxysmal AF. Radiofrequency ablation is an accepted therapy in patients for whom antiarrhythmic drugs have failed; however, its role as a first-line therapy needs further investigation. OBJECTIVE: To compare radiofrequency ablation with antiarrhythmic drugs (standard therapy) in treating patients with paroxysmal AF as a first-line therapy. DESIGN, SETTING, AND PATIENTS: A randomized clinical trial involving 127 treatment-naive patients with paroxysmal AF were randomized at 16 centers in Europe and North America to received either antiarrhythmic therapy or ablation. The first patient was enrolled July 27, 2006; the last patient, January 29, 2010. The last follow-up was February 16, 2012. INTERVENTIONS: Sixty-one patients in the antiarrhythmic drug group and 66 in the radiofrequency ablation group were followed up for 24 months. MAIN OUTCOMES AND MEASURES: The time to the first documented atrial tachyarrhythmia of more than 30 seconds (symptomatic or asymptomatic AF, atrial flutter, or atrial tachycardia), detected by either scheduled or unscheduled electrocardiogram, Holter, transtelephonic monitor, or rhythm strip, was the primary outcome. Secondary outcomes included symptomatic recurrences of atrial tachyarrhythmias and quality of life measures assessed by the EQ-5D tool. RESULTS: Forty-four patients (72.1%) in the antiarrhythmic group and in 36 patients (54.5%) in the ablation group experienced the primary efficacy outcome (hazard ratio [HR], 0.56 [95% CI, 0.35-0.90]; P = .02). For the secondary outcomes, 59% in the drug group and 47% in the ablation group experienced the first recurrence of symptomatic AF, atrial flutter, atrial tachycardia (HR, 0.56 [95% CI, 0.33-0.95]; P = .03). No deaths or strokes were reported in either group; 4 cases of cardiac tamponade were reported in the ablation group. In the standard treatment group, 26 patients (43%) underwent ablation after 1-year. Quality of life was moderately impaired at baseline in both groups and improved at the 1 year follow-up. However, improvement was not significantly different among groups. CONCLUSIONS AND RELEVANCE: Among patients with paroxysmal AF without previous antiarrhythmic drug treatment, radiofrequency ablation compared with antiarrhythmic drugs resulted in a lower rate of recurrent atrial tachyarrhythmias at 2 years. However, recurrence was frequent in both groups. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00392054 Copyright 2014 American Medical Association. All rights reserved.
Meincke F.,Asklepios Klinik St. Georg |
Schmidt-Salzmann M.,Asklepios Klinik St. Georg |
Kreidel F.,Asklepios Klinik St. Georg |
Kuck K.-H.,Asklepios Klinik St. Georg |
Bergmann M.W.,Asklepios Klinik St. Georg
EuroIntervention | Year: 2013
Aims: The WATCHMAN® device was proven non-inferior to oral anticoagulation (OAT). However, periprocedural risks and uncertainty regarding patients with absolute contraindication for OAT limit the overall utilisation of this approach. We investigated the periprocedural safety of dual platelet inhibition and primary utilisation of larger device diameters in order to minimise peri-device leakage and repositioning of the device during the implantation process. Methods and results: Since 2010, 59 consecutive patients have been treated with the WATCHMAN® device and followed for six months. In patients with contraindications to warfarin, dual antiplatelet therapy (DAPT) was used during the first 45 days after implantation instead of warfarin. Device size was chosen 15-30% greater than the LAA diameter in order to minimise device repositioning and leakage, and to prevent device embolisation. Small, non-trabecular recesses at the superior ridge towards the inferior, left pulmonary vein were regularly observed and followed by transoesophageal echo regarding thrombus formation. We observed a 3.3% rate of pericardial effusions and a 5% rate of thrombi at the device during the healing period of 45 days and no device embolisations. One thromboembolic event without clinical sequelae was observed during the six-month follow-up period. All patients stopped DAPT at six months as no primary or secondary leakage >5 mm around the device perimeter was observed. Conclusions: Our data suggest that DAPT can be used safely during the first 45 days in patients with contraindications to warfarin. An algorithm employing larger devices in relation to the LAA ostium with consecutively larger compression improved procedural safety compared to the current standard regarding leakage and device repositioning. © Europa Digital & Publishing 2013. All rights reserved.
Meincke F.,Asklepios Klinik St. Georg |
Kuck K.-H.,Asklepios Klinik St. Georg |
Bergmann M.W.,Asklepios Klinik St. Georg
Catheterization and Cardiovascular Interventions | Year: 2014
The use of bioresorbable vascular scaffolds (BVS) in percutaneous coronary interventions holds great promise and the AbsorbVR BVS is increasingly used in clinical practice outside of controlled studies. However, questions have been raised concerning the delivery of the scaffold to complex lesions. We describe a case of successful delivery and implantation of two overlapping AbsorbVR BVS to a complex lesion in the left anterior descending artery. The crossing of the lesions was uneventful and after implantation a good acute result could be documented. A follow-up angiogram after 3 months proofed a stable midterm result. We thereby demonstrate the feasibility of delivering Absorb® BVS to more complex lesions than practiced so far in the setting of clinical trials. © 2013 Wiley Periodicals, Inc.
Sedighiani F.,ASKLEPIOS Klinik St. Georg |
Nikol S.,ASKLEPIOS Klinik St. Georg
Surgeon | Year: 2011
Background and purpose of the study: Peripheral artery disease is a highly prevalent disease which is characterised by high unmet medical need particularly in the more advanced stages of disease. Options comprise the need for vessel regeneration using therapeutic angiogenic gene therapy as well as the prevention of restenosis post-angioplasty using local gene therapy. Both problems have been addressed by extensive research. Recent advances in the knowledge of the complex regulation of angiogenesis and arteriogenesis and ways to its induction offer hope for a novel strategy that is based on the generation of such new vessels. This strategy termed " therapeutic angiogenesis" is a concept based on the use of angiogenic factors or stem cells or their combination to promote neovascularisation for the treatment of ischaemic tissues. This manuscript summarises the development of therapeutic angiogenic strategies using gene therapy. Methods: Review of current publications of phase I, II and III clinical trials and websites. Main findings: Phase II trials performed so far are difficult to compare due to different genes, vectors and applications routes used and different endpoints evaluated. Recently, the largest phase III trial did not confirm efficacy of non-viral gene transfer using the gene for fibroblast growth factor 1 in critical limb ischaemia. Conclusions: Cardiovascular gene therapy, particularly, therapeutic angiogenesis has been shown to be safe, however, did not prove consistently efficacious in randomised controlled trials. © 2011 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland.
Geidel S.,Asklepios Klinik St. Georg |
Schmoeckel M.,Asklepios Klinik St. Georg
Annals of Thoracic Surgery | Year: 2014
Background This study analyzed the effect of failed percutaneous mitral intervention with the MitraClip device (Abbott Laboratories, Abbott Park, IL) on subsequent mitral valve (MV) operations. Methods Nineteen patients (74 ± 9 years) with treatment failure after implantation of 37 MitraClips (mean, 1.9 ± 0.8; range, 1 to 4) for functional or degenerative MV disease underwent operations a median of 12 days later (range, 0 to 546 days). All patients were studied before and after the operation by clinical investigation and echocardiographic analysis. Intraoperative findings and the effect on the operation were analyzed and are described in detail. Data before clipping and at the time of operation were compared, and the surgical outcome was recorded. Results There was a significant increase in risk between that at the time of clipping and that at subsequent operations, noted as a rise of the European System for Cardiac Operative Risk Evaluation II from a median 12.74% to 26.87%, respectively (p < 0.0001, Wilcoxon signed rank test). Severe clip implantation-induced tissue damage was found in most patients. Surgical MV repair could be performed in 5 of 6 patients (83%) with a 1-clip implant and in only 3 of 13 patients (23%) when 2 or more clips had been inserted (p = 0.0188, Wilcoxon-Mann-Whitney test). All patients required other associated procedures: closure of an artificial atrial septal defect that was caused by the clipping procedure (100%), tricuspid valve repair (37%), atrial fibrillation ablation operations (37%), coronary artery bypass grafting (16%), and aortic valve replacement (11%). Two early cardiac deaths (< 30 days) occurred. Survival at 1 year was 68%. Conclusions There is a remarkable impact of failed clipping procedures on MV operations. We observed a severely aggravated cardiac pathology in parallel with a reduced preoperative clinical state compared with the original condition. Moreover, the likelihood of an optimal surgical solution with valve reconstruction was reduced thereafter. However, operations in the critical situation of an unsuccessful mitral clipping procedure should be discussed immediately, because it still seems to be an option compared with conservative therapy. © 2014 by The Society of Thoracic Surgeons.
Brunken C.,Asklepios Klinik St. Georg |
Seitz C.,Medical University of Vienna |
Woo H.H.,University of Sydney
BJU International | Year: 2015
Objective To systematically review the literature regarding clinical outcomes of 180-W XPS GreenLight® laser (GL) vaporisation for the treatment of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH). Methods Recent publications were identified in the field of 180-W GL vaporisation for the treatment of LUTS due to BPH. We searched for peer-reviewed original articles in the English language. Search items were: '180W lithium triborate laser' or '180W greenlight laser' or '180 watt lithium triborate laser' or '180 watt greenlight laser' or 'XPS greenlight laser'. In all, 30 papers published between 2012 and 2014 matched this search. Of these, 10 papers were identified dealing with consecutive cohorts of patients treated with the 180-W XPS GL Results The 10 papers included a total experience of 1640 patients. The only randomised controlled trial in this field compares 180-W with transurethral resection of the prostate (TURP). Functional outcomes and prostate volume reduction after GL vaporisation were similar to TURP. Catheterisation time and hospital stay were shorter in patients undergoing 180W XPS GL vaporisation (41 and 66 h vs 60 and 97 h, respectively). Four papers compared the 180-W XPS system to former GL devices showing increased operation time efficiency and comparable postoperative voiding results and adverse events. One paper defined the learning curve to achieve an expert level according to the speed of the procedure and the effectiveness of volume reduction was met after 120 procedures. Conclusion The 180-W XPS GL offers shorter operation times than former devices. In the one randomised controlled trial comparison with TURP, volume reduction and functional results were comparable to those of TURP. Longer term studies are required. © 2014 The Authors © 2014 BJU International Published by John Wiley & Sons Ltd.
Neven K.,Asklepios Klinik St. Georg |
Metzner A.,Asklepios Klinik St. Georg |
Schmidt B.,Asklepios Klinik St. Georg |
Ouyang F.,Asklepios Klinik St. Georg |
Kuck K.-H.,Asklepios Klinik St. Georg
Heart Rhythm | Year: 2012
Background and Objective: High-intensity frequency ultrasound (HIFU) can achieve pulmonary vein isolation (PVI), but severe complications have happened. An esophageal temperature (ET)-guided safety algorithm was implemented. We investigated medium-term outcome. Methods: After left atrial access, HIFU was applied until complete PVI. The safety algorithm was as follows: ≤3 complete ablations per pulmonary vein, early abortion when ET <40.0°C, use of Power Modulation at ET >39.0°C or when after 20 to 30 seconds no change in PV electrograms: to reduce the ablation temperature in the surrounding tissue, acoustic power is switched on and off with a frequency of 1 Hz; in all first ablations, use of Power Modulation after 50% of programmed time. Touch-up radiofrequency ablation when PVI failed. Follow-up included interviews and Holter electrocardiograms. Recurrence was defined as atrial fibrillation (AF) >30 seconds without a blanking period. Results: A total of 28 symptomatic patients (18 males, age 63 years), with paroxysmal AF (n = 19) and persistent AF (n = 9) were included. After a median follow-up of 738 days, 22 of the 28 patients (79%) were free of AF without antiarrhythmic drugs. After 1 repeat procedure with radiofrequency ablation, 5 patients remained free of AF. The complications were as follows: 1 lethal atrial-to-esophageal fistula at day 31, 1 pericardial effusion at day 48, 1 unexplained death at day 49, and 2 persistent phrenic nerve palsies with full recovery within 12 months. Conclusions: Two-year follow-up after PVI using HIFU and an ET-guided safety algorithm shows success rates similar to those of radiofrequency-based procedures but with higher complication rates. Importantly, the ET-guided safety algorithm failed to prevent severe complications. HIFU does not meet safety standards required for the treatment of AF, and this led to a halt of its clinical use. © 2012 Heart Rhythm Society. All rights reserved.
Tilz R.R.,Asklepios Klinik St. Georg |
Rillig A.,Asklepios Klinik St. Georg |
Thum A.-M.,Asklepios Klinik St. Georg |
Arya A.,Asklepios Klinik St. Georg |
And 7 more authors.
Journal of the American College of Cardiology | Year: 2012
Objectives: This study describes the 5-year efficacy of catheter ablation for long-standing persistent atrial fibrillation (LS-AF). Background: Long-term outcome data after catheter ablation for LS-AF are limited. Methods: Long-term follow-up of 56 months (range 49 to 67 months) was performed in 202 patients (age 61 ± 9 years) who underwent the sequential ablation strategy for symptomatic LS-AF. Initial ablation strategy was circumferential pulmonary vein isolation (PVI). Additional ablation was performed only in acute PVI nonresponder, if direct current cardioversion failed after PVI. Results: After the first ablation procedure, sinus rhythm was documented in 41 of 202 (20.3%) patients. After multiple procedures, sinus rhythm was maintained in 91 of 202 (45.0%) patients, including 24 patients receiving antiarrhythmic drugs. In 105 patients, PVI was the sole ablative therapy, 49 (46.7%) of those patients remained in sinus rhythm during follow-up. Patients with a total AF duration of <2 years had a significantly higher ablation success rate than patients whose AF duration was >2 years (76.5% vs. 42.2%, respectively; p = 0.033). Persistent AF duration (hazard ratio: 1.09 [95% confidence interval: 1.04 to 1.13]; p < 0.001) independently predicted arrhythmia recurrences, and acute PVI responders had a reduced risk of relapse (hazard ratio: 0.57 [95% confidence interval: 0.41 to 0.78]; p < 0.001) after the first ablation. Conclusions: During 5-year follow-up, single- and multiple ablation procedure success was 20% and 45%, respectively, for patients with LS-AF. For patients with a total AF duration of <2 years, the outcomes were favorable. © 2012 American College of Cardiology Foundation.
Wissner E.,Asklepios Klinik St. Georg
Journal of Cardiovascular Electrophysiology | Year: 2012
Long-Term Outcome After Substrate-Based Ablation of LPF VT During SR. Background: Catheter ablation of left posterior fascicular (LPF) ventricular tachycardia (VT) is commonly performed during tachycardia. This study reports on the long-term outcome of patients undergoing ablation of LPF VT targeting the earliest retrograde activation within the posterior Purkinje fiber network during sinus rhythm (SR). Methods: This study retrospectively analyzed 24 consecutive patients (8 female; mean age 26 ± 11 years) referred for catheter ablation of electrocardiographically documented LPF VT. Programmed stimulation was performed to induce tachycardia, while mapping and ablation was aided by use of a 3D electroanatomical mapping system. Catheter ablation targeted the earliest potential suggestive of retrograde activation within the posterior Purkinje fiber network (retro-PP) recorded along the posterior mid-septal left ventricle during SR if LPF VT was noninducible. Results: Overall, 21/24 (87.5%) patients underwent successful catheter ablation in SR targeting the earliest retro-PP, while 3/24 (12.5%) patients were successfully ablated during tachycardia. In none of the patients, ablation resulted in LPF block. No procedure-related complications occurred. After a median follow-up period of 8.9 (4.8-10.9) years, 22/24 (92%) patients were free from recurrent VT. Conclusion: In patients presenting with LPF VT, ablation of the earliest retro-PP along the posterior mid-septal LV during SR results in excellent long-term outcome during a median follow-up period of almost 9 years. (J Cardiovasc Electrophysiol, Vol. 23, pp. 1179-1184, November 2012) © 2012 Wiley Periodicals, Inc.
Brunken C.,Asklepios Klinik St. Georg |
Seitz C.,Medical University of Vienna |
Tauber S.,Asklepios Klinik St. Georg |
Schmidt R.,Asklepios Klinik St. Georg
Journal of Endourology | Year: 2011
Background and Purpose: GreenLight laser vaporization is established as a minimally invasive procedure to treat patients with benign prostatic hyperplasia. Despite good functional results, it may be difficult to achieve adequate tissue removal for large prostates. In this study, we evaluated whether a transurethral enucleation technique is feasible with the GreenLight laser as a possible way to improve the amount of tissue removed. Patients and Methods: Following the technique described by Gilling for the holmium laser, we carried out transurethral enucleation of prostate adenoma with the 120W HPS GreenLight laser in 21 consecutive patients. Preoperative data were collected prospectively; prostate volume, International Prostate Symptom Score (IPSS), postvoid residual (PVR), prostate-specific antigen level, peak urinary flow rate, operative time, catherization period, length of hospitalization, and perioperative complications were recorded as well as the weight of the enucleated tissue and the applied laser energy. For follow-up, IPSS and PVR were recorded. Data are presented as mean±standard deviation. Results: Fifty-two percent of the patients had preoperative urinary retention. Preoperative prostate volume was 74.6±21.7cc; 34.7±21.7g of tissue were enucleated. IPSS was reduced from 25±6 to 5±9 (P=0.0001), PVR from 126±80 to 11±18 (P=0.002) by GreenLight laser enucleation. Serious complications were not observed. Operative time was 112±27minutes. Catheter time was 1.2±0.4 days. The length of hospitalization was 3.6±0.9 days. Conclusion: GreenLight laser enucleation is feasible and safe. Tissue reduction is complete, and good functional results are achieved. All patients were able to void properly. Major complications were not observed. The procedure is technically demanding, resulting in long operative times at the first interventions. © 2011 Mary Ann Liebert, Inc.