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Selected AbstractsA randomized comparison of the magnetic navigation system versus conventional percutaneous coronary intervention,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 6 2008DPHIL, Steve Ramcharitar BMBCH Abstract Objective: A randomized comparison of the magnetic navigation system (MNS) to conventional guidewire techniques in percutaneous coronary interventions. Background: The MNS precisely directs a magnetized guidewire in vivo through two permanent external magnets. Methods: A total of 111 consecutive patients were enrolled. Crossing success, crossing-/fluoroscopy times, and contrast usage were directly compared. Lesions were classified according to the AHA/ACC criteria. Three tertiles of vessel/lesion complexity [low (<5), medium (6,10) and high (>10)] were defined using 3D reconstructions and angiographic information. Results: The crossing success for magnetic and the conventional wires were 93.3and 95.6%, respectively. Crossing and fluoroscopy times were longer with the magnetic wires (72.9 ± 50.3 sec vs. 58.1 ± 47.2 sec, P < 0.001 and 66.2 ± 44.1 sec vs. 55.2 ± 44.4 sec, P = 0.03, respectively). In vessels with low and medium complexity the magnetic wires had significantly longer times (P < 0.001) but for those with high scores (>10) a trend towards shorter times was observed. The MNS resulted in a small but significant reduction in contrast usage (2.3 ± 3.5 ml vs. 4.5 ± 4.4 ml, P < 0.001). Moreover by superimposing a virtual roadmap of the vessel on the live fluoroscopy image 48% of the lesions were crossed without requiring contrast agents with the MNS. Conclusion: The MNS has comparable crossing success to conventional PCI. It is relatively slower but there is a trend to support a potential advantage in more complex vessels. By simultaneously employing a virtual roadmap there is a small but significant reduction in contrast usage. © 2008 Wiley-Liss, Inc. [source] Persistence of Pulmonary Vein Isolation After Robotic Remote-Navigated Ablation for Atrial Fibrillation and its Relation to Clinical OutcomeJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 10 2010STEPHAN WILLEMS M.D. Robotic Remote Ablation for AF. Aims: A robotic navigation system (RNS, HansenÔ) has been developed as an alternative method of performing ablation for atrial fibrillation (AF). Despite the growing application of RNS-guided pulmonary vein isolation (PVI), its consequences and mechanisms of subsequent AF recurrences are unknown. We investigated the acute procedural success and persistence of PVI over time after robotic PVI and its relation to clinical outcome. Methods and Results: Sixty-four patients (60.7 ± 9.8 years, 53 male) with paroxysmal AF underwent robotic circumferential PVI with 3-dimensional left atrial reconstruction (NavXÔ). A voluntary repeat invasive electrophysiological study was performed 3 months after ablation irrespective of clinical course. Robotic PVI was successful in all patients without complication (fluoroscopy time: 23.5 [12,34], procedure time: 180 [150,225] minutes). Fluoroscopy time demonstrated a gradual decline but was significantly reduced after the 30th patient following the introduction of additional navigation software (34 [29,45] vs 12 [9,17] minutes; P < 0.001). A repeat study at 3 months was performed in 63% of patients and revealed electrical conduction recovery in 43% of all PVs. Restudied patients without AF recurrence (n = 28) showed a significantly lower number of recovered PVs (1 (0,2) vs 2 (2,3); P = 0.006) and a longer LA-PV conduction delay than patients with AF recurrences (n = 12). Persistent block of all PVs was associated with freedom from AF in all patients. At 3 months, 67% of patients were free of AF, while reablation of recovered PVs led to an overall freedom from AF in 81% of patients after 1 year. Conclusion: Robotic PVI for PAF is safe, effective, and requires limited fluoroscopy while yielding comparable success rates to conventional ablation approaches with PV reconduction as a common phenomenon associated with AF recurrences. (J Cardiovasc Electrophysiol, Vol. 21, pp. 1079-1084) [source] Endocardial Mapping of Right Ventricular Outflow Tract Tachycardia Using Noncontact Activation MappingJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 6 2003Michael Ribbing M.D. Introduction: Activation mapping and pace mapping identify successful ablation sites for catheter ablation of right ventricular outflow tract (RVOT) tachycardia. These methods are limited in patients with nonsustained tachycardia or isolated ventricular ectopic beats. We investigated the feasibility of using noncontact mapping to guide the ablation of RVOT arrhythmias. Methods and Results: Nine patients with RVOT tachycardia and three patients with ectopic beats were studied using noncontact mapping. A multielectrode array catheter was introduced into the RVOT and tachycardia was analyzed using a virtual geometry. The earliest endocardial activation estimated by virtual electrograms was displayed on an isopotential color map and measured33 ± 13 msecbefore onset of QRS. Virtual unipolar electrograms at this site demonstrated QS morphology. Guided by a locator signal, ablation was performed with a mean of6.9 ± 2.2radiofrequency deliveries. Acute success was achieved in all patients. During follow-up, one patient had a recurrence of RVOT tachycardia. Compared with patients(n = 21)who underwent catheter ablation using a conventional approach, a higher success rate was achieved by noncontact mapping. Procedure time was significantly longer in the noncontact mapping group. Fluoroscopy time was not significantly different in the two groups. Conclusion: Noncontact mapping can be used as a reliable tool to identify the site of earliest endocardial activation and to guide the ablation procedure in patients with RVOT tachycardia and in patients with ectopic beats originating from the RVOT. (J Cardiovasc Electrophysiol, Vol. 14, pp. 602-608, June 2003) [source] Nonfluoroscopic Three-Dimensional Mapping for Arrhythmia Ablation: Tool or Toy?JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 3 2000APICHAI KHONGPHATTHANAYOTHIN M.D. Arrhythmia Ahlation with Nonfluoroscopic 3D Mapping. Introduction: Conventional mapping and ablation rely on fluoroscopy, which can result in imprecise positioning of the ablation catheter and long fluoroscopic exposure times. We evaluated a nonfluoroscopic three-dimensional mapping system, termed CARTO, and compared the results of ablation using this technique with those of conventional mapping. Methods and Results: We compared the results of 88 arrhythmia ablations (79 patients) using CARTO with 100 ablations (94 patients) using the conventional technique. The ablations were separated into four groups: (1) AV nodal reentrant tachycardia (AVNRT); (2) atrial tachycardia/flutter; (3) ventricular tacbycardia (VT); and (4) bypass tract tachycardia. We compared the success rate, complications, and fluoroscopy and procedure times. Tbe ablation outcomes were excellent and comparable in all four types of the arrhythmias between the two techniques. Major complications included one cardiac tamponade in each group and one second-degree AV block in the conventional group. Fluoroscopy time was shorter using the CARTO technique: 10 ± 7 versus 27 ± 15 minutes for AVNRT (P < 0.01), 18 ± 17 versus 44 ± 23 minutes for atrial tachycardia and flutter (P < 0.01), 15 ± 12 versus 34 ± 31 minutes for VT (P < 0.05), and 21 ± 14 versus 53 ± 32 minutes for bypass tract tachycardia (P < 0.01). Procedure times were similar except for the bypass tract patients, wbich was shorter in the CARTO group, 4 ± 1.3 versus 5.5 ± 2.5 hours (P < 0.01). Conclusion: The electroanatomic three-dimensional mapping technique reduced fluoroscopy time and resulted in excellent outcome without increasing the procedure time. [source] Transcatheter closure of very large (, 25 mm) atrial septal defects using the Amplatzer septal occluderCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 4 2003Bhava Ramalingam Jawahar Kannan MD Abstract Between June 1999 and September 2002, 45 patients (age, 34 ± 13 years; mean shunt ratio, 2.6 ± 0.6) underwent transcatheter atrial septal defect (ASD) closure at our institution with the Amplatzer septal occluder (mean device size, 31.4 ± 3 mm). Patients were selected by transesophageal echocardiography. The mean ASD dimension was 25.3 ± 3.7 mm and 33 (73%) patients had deficient anterior rim. Specific procedural details included the use of 13 or 14 Fr introducer sheaths and the right upper pulmonary vein approach if the conventional approach failed. There were two procedural failures, with device embolization in both (surgical retrieval in one, catheter retrieval in one). During follow-up (3,30 months; median, 16 months), one patient (59 years) with previous atrial flutter had pulmonary embolism and was managed with anticoagulation. Two patients developed symptomatic atrial flutter. Fluoroscopy time was 31.6 ± 19.5 min for the first 22 cases and 19.6 ± 11.4 min for the rest (P = 0.04). Transcatheter closure of large ASDs is technically feasible but careful long-term follow-up is needed to document its safety. Cathet Cardiovasc Intervent 2003;59:522,527. © 2003 Wiley-Liss, Inc. [source] Persistence of Pulmonary Vein Isolation After Robotic Remote-Navigated Ablation for Atrial Fibrillation and its Relation to Clinical OutcomeJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 10 2010STEPHAN WILLEMS M.D. Robotic Remote Ablation for AF. Aims: A robotic navigation system (RNS, HansenÔ) has been developed as an alternative method of performing ablation for atrial fibrillation (AF). Despite the growing application of RNS-guided pulmonary vein isolation (PVI), its consequences and mechanisms of subsequent AF recurrences are unknown. We investigated the acute procedural success and persistence of PVI over time after robotic PVI and its relation to clinical outcome. Methods and Results: Sixty-four patients (60.7 ± 9.8 years, 53 male) with paroxysmal AF underwent robotic circumferential PVI with 3-dimensional left atrial reconstruction (NavXÔ). A voluntary repeat invasive electrophysiological study was performed 3 months after ablation irrespective of clinical course. Robotic PVI was successful in all patients without complication (fluoroscopy time: 23.5 [12,34], procedure time: 180 [150,225] minutes). Fluoroscopy time demonstrated a gradual decline but was significantly reduced after the 30th patient following the introduction of additional navigation software (34 [29,45] vs 12 [9,17] minutes; P < 0.001). A repeat study at 3 months was performed in 63% of patients and revealed electrical conduction recovery in 43% of all PVs. Restudied patients without AF recurrence (n = 28) showed a significantly lower number of recovered PVs (1 (0,2) vs 2 (2,3); P = 0.006) and a longer LA-PV conduction delay than patients with AF recurrences (n = 12). Persistent block of all PVs was associated with freedom from AF in all patients. At 3 months, 67% of patients were free of AF, while reablation of recovered PVs led to an overall freedom from AF in 81% of patients after 1 year. Conclusion: Robotic PVI for PAF is safe, effective, and requires limited fluoroscopy while yielding comparable success rates to conventional ablation approaches with PV reconduction as a common phenomenon associated with AF recurrences. (J Cardiovasc Electrophysiol, Vol. 21, pp. 1079-1084) [source] Reduced Fluoroscopy During Atrial Fibrillation Ablation: Benefits of Robotic Guided NavigationJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 1 2010DANIEL STEVEN M.D. Reduced Fluoroscopy in PVI Using RN.,Background: Recently, a nonmagnetic robotic navigation system (RN, Hansen-SenseiÔ) has been introduced for remote catheter manipulation. Objective: To investigate the influence of RN combined with intuitive 3-dimensional mapping on the fluoroscopy exposure to operator and patient during pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) in a prospective randomized trial. Methods: Sixty patients were randomly assigned to undergo PVI either using a RN guided (group 1; n = 30, 20 male, 62 ± 7.7 years) or conventional ablation approach (group 2; n = 30, 14 male, 61 ± 7.6 years). A 3-dimensional mapping system (NavXÔ) was used in both groups. Results: Electrical disconnection of the ipsilateral pulmonary veins (PVs) was achieved in all patients. Use of RN significantly lowered the overall fluoroscopy time (9 ± 3.4 vs 22 ± 6.5 minutes; P < 0.001) and reduced the operator's fluoroscopy exposure (7 ± 2.1 vs 22 ± 6.5 minutes; P < 0.001). The difference in fluoroscopy duration between both groups was most pronounced during the ablation part of the procedure (3 ± 2.4 vs 17 ± 6.3 minutes; P < 0.001). The overall procedure duration tended to be prolonged using RN without reaching statistical significance (156 ± 44.4 vs 134 ± 12 minutes, P = 0.099). No difference regarding outcome was found during a midterm follow-up of 6 months (AF freedom group 1 = 73% vs 77% in group 2 [P = 0.345]). Conclusion: The use of RN for PVI seems to be effective and significantly reduces overall fluoroscopy time and operator's fluoroscopy exposure without affecting mid-term outcome after 6-month follow-up. (J Cardiovasc Electrophysiol, Vol. 21, pp. 6,12, January 2010) [source] First Experiences for Pulmonary Vein Isolation with the High-Density Mesh Ablator (HDMA): A Novel Mesh Electrode Catheter for Both Mapping and Radiofrequency Delivery in a Single UnitJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 4 2009AXEL MEISSNER M.D. Background: Interventional therapy of atrial fibrillation (AF) is often associated with long examination and fluoroscopy times. The use of mapping catheters in addition to the ablation catheter requires multiple transseptal sheaths for left atrial access. Objectives: The purpose of this prospective study was to evaluate feasibility and safety of pulmonary vein (PV) isolation using the high-density mesh ablator (HDMA), a novel single, expandable electrode catheter for both mapping and radiofrequency (RF) delivery at the left atrium/PV junctions. Methods: Twenty-six patients with highly symptomatic paroxysmal AF (14, 53.8%) and persistent AF (12, 46.2%) were studied. Segmental PV isolation via the HDMA was performed using a customized pulsed RF energy delivery program (target temperature 55,60°C, power 70,100 W, 600,900 seconds RF application time/PV). Results: All 104 PVs in 26 patients could be ablated by the HDMA. Segmental PV isolation was achieved with a mean of 3.25 ± 1.4 RF applications for a mean of 603 ± 185 seconds. Entrance conduction block was obtained in 94.2% of all PV. The mean total procedure and fluoroscopy time was 159.0 ± 32 minutes and 33.5 ± 8.6 minutes, respectively. None of the patients experienced severe acute complications. After 3 months no PV stenosis was observed, and 85.6% and 41.6% of the patients with PAF and persistent AF, respectively, did not report symptomatic AF. Conclusions: In this first study of PV isolation using the HDMA, our findings suggest that this method is safe and yields good primary success rates. The HDMA simplifies AF ablation, favorably impacting procedure and fluoroscopy times. [source] Clinical Experience with a Single Catheter for Mapping and Ablation of Pulmonary Vein OstiumJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 4 2009PAOLO DE FILIPPO M.D. Introduction: The aim of this single center study is to evaluate the safety and the efficacy of performing pulmonary vein isolation (PVI) using a single high-density mesh ablator (HDMA) catheter. Methods: A total of 17 consecutive patients with paroxysmal (10 patients) or persistent atrial fibrillation (7 patients) and no heart disease were enrolled. A single transseptal puncture was performed and the HDMA was placed at each PV ostium identified with anatomic and electrophysiological mapping. Pulsed radiofrequency (RF) energy was delivered at the targeted temperature of 58°C with maximum power of 80 watts. No other ablation system was utilized. The primary objective of the study was acute isolation of the targeted PV, and the secondary objective was clinical efficacy and safety of PVI with HDMA for atrial fibrillation (AF) prevention. Patients were followed at intervals of 1, 3, 6, and 12 months. Results: PVI was attempted with HDMA in 67/67 PVs. [Correction made after online publication October 27, 2008: PVs changed from 6/67 to 67/67] Acute success rate were: 100% (16/16) for left superior PV, 100% (16/16) for left inferior PV, 100% (17/17) for right superior PV, 100% (1/1) for left common trunk and 47% (8/17) for right inferior PV. Total procedure time was 200 ± 36 minutes (range 130,240 minutes) and total fluoroscopy time was 42 ± 18 minutes (range 23,75 minutes). During a mean follow-up of 11 ± 4 months, 64% of patients remained in sinus rhythm (8/10 paroxysmal AF and 3/7 for persistent AF). No complications occurred either acutely or at follow-up. Conclusions: PV isolation with HDMA is feasible and safe. The midterm efficacy in maintaining sinus rhythm is higher in paroxysmal than in persistent patients. [source] Initial Clinical Experience with Cardiac Resynchronization Therapy Utilizing a Magnetic Navigation SystemJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 2 2007PETER GALLAGHER M.D. Introduction: The placement of left ventricular (LV) leads during cardiac resynchronization therapy (CRT) involves many technical difficulties. These difficulties increase procedural times and decrease procedural success rates. Methods and Results: A total of 50 patients with severe cardiomyopathy (mean LV ejection fraction was 21 ± 6%) and a wide QRS underwent CRT implantation. Magnetic navigation (Stereotaxis, Inc.) was used to position a magnet-tipped 0.014, guidewire (CronusÔ guidewire) within the coronary sinus (CS) vasculature. LV leads were placed in a lateral CS branch, either using a standard CS delivery sheath or using a "bare-wire" approach without a CS delivery sheath. The mean total procedure time was 98.1 ± 29.1 minutes with a mean fluoroscopy time of 22.7 ± 15.1 minutes. The mean LV lead positioning time was 10.4 ± 7.6 minutes. The use of a delivery sheath was associated with longer procedure times 98 ± 32 minutes vs 80 ± 18 minutes (P = 0.029), fluoroscopy times 23 ± 15 minutes vs 13 ± 4 minutes (P = 0.0007) and LV lead positioning times 10 ± 6 minutes vs 4 ± 2 minutes (P = 0.015) when compared to a "bare-wire" approach. When compared with 52 nonmagnetic-assisted control CRT cases, magnetic navigation reduced total LV lead positioning times (10.4 ± 7.6 minutes vs 18.6 ± 18.9 minutes; P = 0.005). If more than one CS branch vessel was tested, magnetic navigation was associated with significantly shorter times for LV lead placement (16.2 ± 7.7 minutes vs 36.4 ± 23.4 minutes; P = 0.004). Conclusions: Magnetic navigation is a safe, feasible, and efficient tool for lateral LV lead placement during CRT. Magnetic navigation during CRT allows for control of the tip direction of the CronusÔ 0.014, guidewire using either a standard CS delivery sheath or "bare-wire" approach. Although there are some important limitations to the 0.014, CronusÔ magnetic navigation can decrease LV lead placement times compared with nonmagnetic-assisted control CRT cases, particularly if multiple CS branches are to be tested. [source] Improved Localization of Right-Sided Accessory Pathways with Microcatheter-Assisted Right Coronary Artery Mapping in ChildrenJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 11 2004MAULLY J. SHAH M.B.B.S. Introduction: Radiofrequency ablation of some right-sided accessory pathways continues to be challenging. The purpose of this study was to evaluate the efficacy of introducing a multielectrode microcatheter in the right coronary artery to localize accessory pathways when conventional mapping was unsuccessful. Methods and Results: A retrospective study was conducted of all right-sided accessory pathway radiofrequency ablation procedures in which a multielectrode microcatheter as a reference in the right coronary artery was used to assist mapping. Between January 1998 and January 2002, 10 patients (5 males) underwent mapping of 11 accessory pathways with this technique at mean age of 12.3 ± 3.8 years. Five patients had Ebstein's anomaly of the tricuspid valve. Accessory pathways were identified in the following locations: right anterior 3, right anterolateral 2, right lateral 1, right posterolateral 2, and right posterior 3. Mean procedure time was 285 ± 70.3 minutes, and fluoroscopy time was 68.7 ± 21 minutes. Average mapping duration prior to microcatheter insertion in the right coronary artery was 136 ± 40 minutes. After microcatheter placement in the right coronary artery, the time to successful ablation of accessory pathways was 38 ± 11 minutes. All 11 (100%) accessory pathways were successfully ablated. Conclusion: Mapping in the right coronary artery with a microcatheter is an effective method to improve localization and successful ablation of difficult right-sided accessory pathways. [source] Catheter Ablation of Common-Type Atrial Flutter Guided by Three-Dimensional Right Atrial Geometry Reconstruction and Catheter Tracking Using Cutaneous Patches:JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 10 2004A Randomized Prospective Study Introduction: EnSite® NavXÔ (NavX) is a novel mapping and navigation system that allows visualization of conventional catheters for diagnostic and ablative purposes and uses them to create a three-dimensional (3D) geometry of the heart. NavX is particularly suitable for ablation procedures utilizing an anatomic approach, as in the setting of common-type atrial flutter (AFL). The aim of this study was to compare NavX-guided and conventional ablation procedures for AFL. Methods and Results: Forty consecutive patients (32 male, 59 ± 12 years) with documented AFL were randomized to undergo fluoroscopy-guided (group I, 20 patients) or NavX-guided (group II, 20 patients) ablation, including 3D isthmus reconstruction. The same catheter setup was used in both groups. The endpoint of bidirectional isthmus block was obtained in all patients. Compared to conventional approaches, NavX-guided procedures significantly reduced fluoroscopy time (5.1 ± 1.4 min vs 20 ± 11 min, P < 0.01) and total x-ray exposure (5.1 ± 3.1 Gycm2 vs 24.9 ± 1.6 Gycm2, P < 0.01). Isthmus geometry reconstruction could be performed in all patients of group II. In 4 patients (20%) of group II, anatomic isthmus variations were detected by NavX. No significant differences in radiofrequency current applications and procedural times were found between the two groups. Conclusion: NavX technology allows geometry reconstruction of the cavotricuspid isthmus. NavX-guided ablation of AFL reduces total x-ray exposure compared to the fluoroscopy-guided approach but does not prolong procedure time. [source] Electroanatomic Versus Fluoroscopic Mapping for Catheter Ablation Procedures:JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 3 2004A Prospective Randomized Study Introduction: The aim of this prospective randomized study was to compare the routine use of electroanatomic imaging (CARTO) with that of conventional fluoroscopically guided activation mapping (conventional) in an unselected population referred for catheter ablation. We sought to compare the two approaches with respect to procedure outcome and duration, radiation exposure, and cost. Methods and Results: All patients undergoing catheter ablation (with the exception of complete AV nodal ablation) were prospectively randomized to either a CARTO or conventional procedure for mapping and ablation. One hundred two patients were randomized. Acute procedural success was similar with either strategy (CARTO vs conventional 43/47 vs 51/55, P > 0.5), as was procedure duration (144 [58] vs 125 [48] min, P = 0.07 (mean [SD]). CARTO was associated with a substantial reduction in fluoroscopy time (9.3 [7.6] vs 28.8 [19.5] min, P < 0.001) and radiation dose (6.2 [6.1] vs 20.8 [32.7] Gray, P = 0.003). CARTO cases used fewer catheters (2.5 [0.7] vs 4.4 [1.1], P < 0.001), but catheter costs were higher (13.8 vs 9.3 units, P < 0.001, where one unit is equivalent to the cost of a nonsteerable quadripolar catheter). Conclusion: For all catheter ablation procedures, even when a center's "learning curve" for CARTO is included, procedure duration and outcome are similar for CARTO and conventional procedures. CARTO is associated with drastically reduced fluoroscopy time and radiation dose. Although fewer catheters are used with CARTO, catheter costs remain higher. (J Cardiovasc Electrophysiol, Vol. 15, pp. 310-315, March 2004) [source] Pulmonary Vein Disconnection Using the LocaLisa Three-Dimensional Nonfluoroscopic Catheter Imaging SystemJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 7 2003Laurent Macle M.D. Introduction: Catheter ablation for atrial fibrillation (AF) is associated with prolonged fluoroscopy times. We prospectively evaluated the use of the LocaLisa three-dimensional nonfluoroscopic catheter imaging system with the aim of reducing fluoroscopy times during pulmonary vein (PV) disconnection. Methods and Results: Fifty-two patients with AF (47 men and 5 women, mean age 53 ± 9 years) underwent disconnection of all four PVs guided by a circumferential mapping catheter. The LocaLisa navigation system was used for real-time three-dimensional nonfluoroscopic imaging of the circumferential mapping catheter and ablation catheter electrodes in 26 patients. Procedural parameters were compared with those of a control group consisting of 26 patients in whom only standard fluoroscopy was used. PV disconnection was performed similarly in both groups by circumferential ablation around the ostia, with the endpoint of disconnecting left atrium to PV breakthroughs. The cumulative duration of radiofrequency (RF) energy delivery, procedural time, and fluoroscopy time required for PV disconnection were compared. Successful disconnection was achieved in all PVs, without acute complications. There was no significant difference in cumulative RF energy delivery: 34.8 ± 11.4 minutes for the nonfluoroscopic imaging group versus 38.2 ± 10.5 minutes for the control group. The fluoroscopy time required for disconnection of all four PVs was significantly lower in the LocaLisa group than in the control group: 8.4 ± 4.3 minutes versus 23.7 ± 9.7 minutes (P < 0.0001). There also was a significant difference in the mean time taken for PV disconnection: 46.5 ± 12.0 minutes for the nonfluoroscopic imaging group versus 66.3 ± 18.9 minutes for the control group (P < 0.0001). Conclusion: By allowing continuous three-dimensional monitoring of ablation and mapping catheter position and orientation, the LocaLisa nonfluoroscopic imaging system significantly reduces fluoroscopy and PV disconnection times. (J Cardiovasc Electrophysiol, Vol. 14, pp. 693,697, July 2003) [source] Usefulness of a New Radiofrequency Thermal Balloon Catheter for Pulmonary Vein Isolation:JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 6 2003A New Device for Treatment of Atrial Fibrillation Introduction: A rapidly firing or triggered ectopic focus located within a pulmonary vein (PV) or close to the PV ostium could induce atrial fibrillation (AF). The aim of this study was to evaluate the efficacy and safety of a radiofrequency thermal balloon catheter for isolation of the PV from the left atrium (LA). Methods and Results: Twenty patients with drug-resistant paroxysmal AF were treated by isolating the superior PVs using an RF thermal balloon catheter. Using a transseptal approach, the balloon, which had an inflated diameter 5 to 10 mm larger than that of the PV ostium, was wedged at the LA-PV junction. It was heated by a very-high-frequency current (13.56 MHZ) applied to the coil electrode inside the balloon for 2 to 3 minutes, and the procedure was repeated up to four times. The balloon center temperature was maintained at 60° to 75°C by regulating generator output. Successful PV isolation was achieved in 19 of the 20 left superior PVs and in all 20 of the right superior PVs and was associated with a decrease in amplitude of the ostial potentials. Total procedure time was1.8 ± 0.5hours, which included22 ± 7minutes of fluoroscopy time. After a follow-up period of8.1 ± 0.8months, 17 patients were free from AF, with 10 not taking any antiarrhythmic drugs and 7 taking the same antiarrhythmic agent as before ablation. Electron beam computed tomography revealed no complications, such as PV stenosis at ablation sites. Conclusion: The PV and its ostial region can be safely and quickly isolated from the LA by circumferential ablation around the PV ostia using a radiofrequency thermal balloon catheter for treatment of AF. (J Cardiovasc Electrophysiol, Vol. 14, pp. 609-615, June 2003) [source] Nonfluoroscopic Three-Dimensional Mapping for Arrhythmia Ablation: Tool or Toy?JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 3 2000APICHAI KHONGPHATTHANAYOTHIN M.D. Arrhythmia Ahlation with Nonfluoroscopic 3D Mapping. Introduction: Conventional mapping and ablation rely on fluoroscopy, which can result in imprecise positioning of the ablation catheter and long fluoroscopic exposure times. We evaluated a nonfluoroscopic three-dimensional mapping system, termed CARTO, and compared the results of ablation using this technique with those of conventional mapping. Methods and Results: We compared the results of 88 arrhythmia ablations (79 patients) using CARTO with 100 ablations (94 patients) using the conventional technique. The ablations were separated into four groups: (1) AV nodal reentrant tachycardia (AVNRT); (2) atrial tachycardia/flutter; (3) ventricular tacbycardia (VT); and (4) bypass tract tachycardia. We compared the success rate, complications, and fluoroscopy and procedure times. Tbe ablation outcomes were excellent and comparable in all four types of the arrhythmias between the two techniques. Major complications included one cardiac tamponade in each group and one second-degree AV block in the conventional group. Fluoroscopy time was shorter using the CARTO technique: 10 ± 7 versus 27 ± 15 minutes for AVNRT (P < 0.01), 18 ± 17 versus 44 ± 23 minutes for atrial tachycardia and flutter (P < 0.01), 15 ± 12 versus 34 ± 31 minutes for VT (P < 0.05), and 21 ± 14 versus 53 ± 32 minutes for bypass tract tachycardia (P < 0.01). Procedure times were similar except for the bypass tract patients, wbich was shorter in the CARTO group, 4 ± 1.3 versus 5.5 ± 2.5 hours (P < 0.01). Conclusion: The electroanatomic three-dimensional mapping technique reduced fluoroscopy time and resulted in excellent outcome without increasing the procedure time. [source] Figulla ASD Occluder versus Amplatzer Septal Occluder: A Comparative Study on Validation of a Novel Device for Percutaneous Closure of Atrial Septal DefectsJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 6 2009AYSENUR PAC M.D. Objectives: Occlutech Figulla ASD Occluder (FSO) is an alternative device to Amplatzer Septal Occluder (ASO) with some structural innovations including increased flexibility, minimizing the amount of material implanted, and absence of the left atrial clamp. We aimed to report our experiences with FSO and compare the outcomes of this novel device versus ASO. Interventions: Between December 2005 and February 2009, 75 patients diagnosed with secundum atrial septal defects underwent transcatheter closure. The FSO device was used in 33 patients, and the ASO was used in 42. Results: Patient characteristics, stretch size of the defect, device left disc size, procedure, and fluoroscopy time were similar between the groups. However, the difference between device waist size and stretched diameter of the defect was significantly higher, and device delivery sheath was significantly larger in FSO group and device left disc size was significantly lower in the FSO group. In all subjects, the residual shunt was small to trivial during follow-up and the reduction in prevalence of residual shunt with time was similar in both groups (P = 0.68). We found no differences in complication rate between the two devices; however, device embolization to the pulmonary bifurcation in one patient was recorded as major complication in FSO device group. Conclusions: Both devices are clinically safe and effective in ASD closure. FSO device has similar outcomes when compared to ASO device. Difficulties in selecting the correct device size in larger defects and larger venous sheath requirement need to be evaluated in further studies. [source] Transesophageal Echocardiography and Intracardiac Echocardiography Differently Predict Potential Technical Challenges or Failures of Interatrial Shunts Catheter-Based ClosureJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 1 2007GIANLUCA RIGATELI M.D. We sought to prospectively assess the role of transesophageal (TEE) and intracardiac echocardiography (ICE) in detecting potential technical difficulties or failures in patients submitted to interatrial shunts percutaneous closure. We prospectively enrolled 46 consecutive patients (mean age 35±28, 8 years, 30 female) referred to our center for catheter-based closure of interatrial shunts. All patients were screened with TEE before the intervention. Patients who met the inclusion criteria underwent ICE study before the closure attempt (40 patients). TEE detected potential technical difficulties in 22.5% (9/40) patients, whereas ICE detected technical difficulties in 32.5% (13/40 patients). In patients with positive TEE/ICE the procedural success (92.4% versus 100% and, P = ns) and follow-up failure rate (7.7% versus 0%, P = ns) were similar to patients with negative TEE/ICE, whereas the fluoroscopy time (7 ± 1.2 versus 5 ± 0.7 minutes, P < 0.03), the procedural time (41 ± 4.1 versus 30 ± 8.2 minutes, P ± 0.03), and technical difficulties rate (23.1% versus 0%, P = 0.013) were higher. Differences between ICE and TEE in the evaluation of rims, measurement of ASD or fossa ovalis, and detection of venous valve and embryonic septal membrane remnants impacted on technical challenges and on procedural and flouroscopy times but did not influence the success rate and follow-up failure rate. [source] Percutaneous Left and Right Heart Catheterization in Fully Anticoagulated Patients Utilizing the Radial Artery and Forearm Vein: A Two-Center ExperienceJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 3 2006TED S. N. LO M.R.C.P. Background: Stopping oral anticoagulants prior to cardiac catheterization is associated with an increased risk of thromboembolism. Performing the procedures via the femoral artery and vein without interruption of anticoagulation is associated with a high rate of major access site complications. The transradial technique for left heart catheterization is safe in fully anticoagulated patients but few data are available on the percutaneous right and left heart catheterization utilizing a combination of the radial artery and antecubital vein in this group of patients. Methods: We report our experience in 28 consecutive patients that underwent left and right heart catheterizations via this percutaneous arm approach without interruption of anticoagulation. These were compared to 31 consecutive non-anticoagulated patients that underwent the procedure via a conventional femoral artery and vein approach. Results: Arterial and venous accesses were achieved and complete angiographic and hemodynamic data obtained in all patients. There were no access site complications in the anticoagulated patients despite an International normalized ratio (INR) of 2.5 ± 0.5. Procedural duration was longer in the anticoagulated group of patients, but fluoroscopy time and patient radiation dose were similar in both groups. Conclusion: Our experience suggests that left and right heart catheterization can be safely performed in most fully anticoagulated patients using this technique with a low bleeding and thromboembolic risk and no increase in radiation exposure. [source] Left Atrial Ablation at the Anatomic Areas of Ganglionated Plexi for Paroxysmal Atrial FibrillationPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 10 2010EVGENY POKUSHALOV M.D., Ph.D. Background:,Modification of left atrial ganglionated plexi (GP) is a promising technique for the treatment of paroxysmal atrial fibrillation (AF) but its therapeutic efficacy is not established. This study aimed at evaluating the effectiveness of anatomic GP modification by means of an implantable arrhythmia monitoring device. Methods:,In 56 patients with paroxysmal AF, radiofrequency ablation at anatomic sites, where the main clusters of GP have been identified in the left atrium, was performed. In all patients, an electrocardiogram monitor (Reveal XT, Medtronic Inc., Minneapolis, MN, USA) was implanted before (n = 7) or immediately after (n = 49) AF ablation. Results:,Average duration of the procedure was 142 ± 18 min and average fluoroscopy time 20 ± 7 min. In total, 53,81 applications of RF energy were delivered (mean of 18.2 ± 3.8 at each of the four areas of GP ablation). Heart rate variability was assessed in 31 patients. Standard deviation of RR intervals over the entire analyzed period, the root mean square of differences between successive RR intervals, and high frequencies decreased, while HRmin, HRmean, and LF to HF ratio increased immediately postablation; these values returned to baseline 6 months after the procedure. At end of 12-month follow-up, 40 (71%) patients were free of arrhythmia recurrence. Ten patients had AF recurrence, two patients had left atrial flutter, and four patients had episodes of flutter as well as AF recurrence. Duration of episodes of AF after ablation gradually decreased over the follow-up period. Conclusions:,Regional ablation at the anatomic sites of the left atrial GP can be safely performed and enables maintenance of sinus rhythm in 71% of patients with paroxysmal AF for a 12-month period. (PACE 2010; 33:1231,1238) [source] Cryoablation for Atrioventricular Nodal Reentrant Tachycardia in Young Patients: Predictors of RecurrencePACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 9 2008NIKHIL K. CHANANI M.D. Background: Recurrence rates of atrioventricular nodal reentry tachycardia (AVNRT) after cryoablation continue to remain high despite excellent initial success rates. Our objective was to evaluate the clinical outcomes of cryoablation for AVNRT with the 4-mm and 6-mm tip cryoablation catheters in a young population and to elicit predictors of arrhythmia recurrence. Methods: We retrospectively reviewed all patients who underwent cryoablation for AVNRT at the UCSF/Stanford Pediatric Arrhythmia Center from January 2004 to February 2007. Results: One hundred fifty-four patients (age 13.7 years (3.2,24.4)) underwent cryoablation for AVNRT of which 144 patients had inducible AVNRT (123 sustained and 21 nonsustained) and 10 had presumed AVNRT. Initial success was achieved in 95% (146/154), with no difference between the 4-mm (93%) and 6-mm (98%) cryoablation catheter tips (P = 0.15). There was no permanent atrioventricular (AV) block. Transient third-degree AV block occurred in nine patients (6%), with no difference between the 4-mm (4%) and 6-mm (9%) tip (P = 0.13). AVNRT recurrence was documented in 14% in a median time of 2.5 months (0.25,20). Recurrences were lower with the 6-mm (9%) versus the 4-mm (18%) tip, but this did not reach statistical significance (P = 0.16). With univariate analysis, a longer fluoroscopy time was the only significant factor associated with recurrence. Multivariate analysis failed to identify any significant predictor of AVNRT recurrence. Conclusion: Outcomes of cryoablation for AVNRT continue to be good without the complication of AV block. We could not identify any specific parameter associated with AVNRT recurrence. Further improvements in cryoablation technique will be necessary to reduce recurrences. [source] Steerable Sheath Catheter Navigation for Ablation of Atrial Fibrillation: A Case-Control StudyPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 7 2008CHRISTOPHER PIORKOWSKI M.D. Background: Lack of stable access to all desired ablation target sites is one of the limitations for efficacious circumferential left atrial (LA) pulmonary vein (PV) ablation. Targeting that, new catheter navigation technologies have been developed. The aim of this study was to describe atrial fibrillation (AF) mapping and ablation using manually controlled steerable sheath catheter navigation and to compare it against an ablation approach with a nonsteerable sheath. Methods and Results: In this case-control-analysis 245 consecutive patients (controls) treated with circumferential left atrial PV ablation were matched with 105 subsequently consecutive patients (cases) ablated with a similar line concept but mapping and ablation performed with a manually controlled steerable sheath. One hundred sixty-six patients were selected to be included into 83 matched patient pairs. Ablation success was measured with serial 7-day Holter electrocardiograms. Patients ablated with the steerable sheath showed an increase in the success rate (freedom from AF) from 56% to 77% (P = 0.009) after a single procedure and 6 months of follow-up. With respect to procedural data no difference could be found for procedure time, fluoroscopy time, irradiation dose, and radiofrequency (RF) burning time. With the steerable sheath mean procedural RF power (33 ± 9 vs 41 ± 4 W; P < 0.0005) and total RF energy delivery (97,498 vs 111,864 J; P < 0.005) were significantly lower and the rate of complete PV isolation significantly increased from 10% to 52% (P < 0.0005). The complication rate was the same in both groups. Among different arrhythmia, procedure, and patient characteristics, the lack of early postinterventional arrhythmia recurrences was the only but powerful predictor for long-term ablation success. Conclusions: An AF mapping and ablation approach solely using a manually controlled steerable sheath for catheter navigation improved the outcome of circumferential left atrial PV ablation at similar intervention times and similar complication rates. The 6-month success rate after a single LA intervention increased from 56% to 77%. [source] Simple Access to the Coronary Venous System for Left Ventricular PacingPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 9 2003DANY E. SAYAD Implantation of the LV lead for biventricular pacing can be challenging, time consuming, and often requires extensive fluoroscopy time. A conventional diagnostic 5 Fr left Amplatz catheter was used to cannulate the coronary sinus in 15 consecutive patients undergoing implantation of a biventricular pacemaker. When the coronary sinus was cannulated, the proximal end of the Amplatz catheter was cut and the coronary sinus sheath was passed over the Amplatz catheter that was then removed. Coronary sinus cannulation was achieved in all 15 patients with a mean fluoroscopy time of3.34 ± 1.9 minutes. Subsequent implantation of a biventricular pacemaker was successful and free of complications in all the 15 patients. (PACE 2003; 26:1856,1858) [source] Implantation of a Dual Chamber Pacing and Sensing Single Pass Defibrillation LeadPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 4 2001RAINER GRADAUS GRADAUS, R., et al.: Implantation of a Dual Chamber Pacing and Sensing Single Pass Defibrillation Lead. Dual-chamber ICDs are increasingly used to avoid inappropriate shocks due to supraventricular tachycardias. Additionally, many ICD patients will probably benefit from dual chamber pacing. The purpose of this pilot study was to evaluate the intraoperative performance and short-term follow-up of an innovative single pass right ventricular defibrillation lead capable of bipolar sensing and pacing in the right atrium and ventricle. Implantation of this single pass right ventricular defibrillation lead was successful in all 13 patients (age 63 ± 8 years; LVEF 0.44 ± 0.16; New York Heart Association [NYHA] 2.4 ± 0.4, previous open heart surgery in all patients). The operation time was 79 ± 29 minutes, the fluoroscopy time 4.7 ± 3.1 minutes. No perioperative complications occurred. The intraoperative atrial sensing was 1.7 ± 0.5 mV, the atrial pacing threshold product was 0.20 ± 0.14 V/ms (range 0.03,0.50 V/ms). The defibrillation threshold was 8.8 ± 2.7 J. At prehospital discharge and at 1-month and 3-month follow-up, atrial sensing was 1.9 ± 0.9, 2.1 ± 0.5, and 2.7 ± 0.6 mV, respectively, (P = NS, P < 0.05, P < 0.05 to implant, respectively), the mean atrial threshold product 0.79, 1.65, and 1.29 V/ms, respectively. In two patients, an intermittent exit block occurred in different body postures. All spontaneous and induced ventricular arrhythmias were detected and terminated appropriately. Thus, in a highly selected patient group, atrial and ventricular sensing and pacing with a single lead is possible under consideration of an atrial pacing dysfunction in 17% of patients. [source] Radiation exposure to anaesthetists during interventional radiology,ANAESTHESIA, Issue 1 2010S. Ismail Summary This prospective study determined the level of radiation exposure of anaesthetists during interventional radiological procedures performed in the endoscopic retrograde cholangiopancreatography suite and cardiac catheterisation laboratory and compared it with the current safety guidelines. Anaesthetists wore area-specific lithium fluoride thermo-luminescent dosimeter badges at standardised positions. A total of 1344 procedures were performed over a 6-month period. Anaesthetists were involved in 39/645 (6.0%) procedures associated with ionisation radiation in the endoscopic retrograde cholangiopancreatography suite and 86/699 (12.3%) in the cardiac catheterisation laboratory. The mean (SD) duration of endoscopic retrograde cholangiopancreatography was 54.8 (29.1) min compared with 67.9 (42.8) min for cardiac catheterisation suite procedures (p = 0.058). The mean (SD) fluoroscopy time per procedure for endoscopic retrograde cholangiopancreatography was 5.5 (4.1) min compared with 12 (10.9) min in the cardiac catheterisation suite (p < 0.001). The combined net radiation exposure over 6 months was 0.28 mSv for endoscopic retrograde cholangiopancreatography procedures and 2.32 mSv in the cardiac catheterisation suite. The combined exposure was less than the maximum recommended exposure of 20 mSv per year. [source] Percutaneous closure of patent foramen ovale with a bioabsorbable occluder device,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 4 2009Single-Centre Experience Abstract Background: Percutaneous closure of patent foramen ovale (PFO) is routinely performed with nonbiological devices, characterized by a persistent low-grade inflammatory response. We report our experience about PFO closure with a bioabsorbable device, BioSTAR® (NMT Inc, USA). Methods: From September 2007 to September 2008, 14 patients with migraine (eight with aura) and cerebral magnetic resonance positive for silent ischemia and nine patients with prior cardiovascular accident (CVA) underwent closure of PFO using BioSTAR®. One patient had heterozygosis for sickle-cell-anaemia. Nickel allergy was present in eight patients. Echocardiogram was performed at 24 hr, one and 6 months. At 6 and 12 months a contrast-transcranial-doppler (c-TCD) and a trans-oesophageal echocardiogram (TOE) were scheduled, respectively. Results: BioSTAR® was successfully implanted in 22 patients (96%). The mean procedural time and the mean fluoroscopy time were 22 ± 6 and 4 ± 2 minutes, respectively. The mean in-hospital stay was 3 ± 0.5 days. After a mean follow-up of 7.8 ± 3.5 months there was an hemorrhagic stroke related to double antiaggregation. No other CVA or allergic reactions were registered. There were two cases of atrial arrhythmia. Fifteen patients had not residual shunts at c-TCD, while in four patients we observed a trivial microbubbles passage. The TOE, achieved in nine patients without contrast, showed the device well positioned, with a low profile and without thrombus. Conclusions: In our experience PFO closure with BioSTAR® is safe and efficacious in preventing recurrent CVA. Its use could be advantageous in patients with nickel allergy and haematological disorders. The potential benefits of this device need to be certified in a larger cohort of patients with a longer follow-up. © 2009 Wiley-Liss, Inc. [source] Catheter-based closure of atrial septal defects in the oval fossa with the Amplatzer® device in patients in their first or second year of life,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2009G. Fischer MD Abstract Objective: To assess feasibility, safety, and efficacy of the use of Amplatzer® occluders in closure of atrial septal defects (ASD) in children in the first 2 years of life. Background: Although scattered reports on such closure have been published, no agreement consists on the policy. Methods: In 654 patients of all ages, closure was achieved in 632 (96.6%). Data were analyzed retrospectively in all 71 children where an attempt had been made to close the ASD before their second birthday. Results: Median age and body weight were 17.2 months (range 3.9,23.8) and 10.0 kg (range 3.8,14.5), respectively. Median fluoroscopy time was 13.6 min and median device size 15 mm. Successful closure was achieved in 68 children (95.8%). Three times the procedure was aborted: in one, the device repeatedly straddled the septum; in the other two, a small left atrium restricted the movement of the left-sided disc. One device embolized and was reimplanted after retrieval. One infant with multiple disorders died 6 days after closure from acute sepsis probably unrelated to the procedure. No other complications occurred. Only trivial shunts closing with time were registered during follow-up. Symptomatic patients profited markedly from closure. Conclusion: The results and complications of ASD closure with the Amplatzer® device in patients in their first 2 years of life compare favorably with procedures in older patients, provided that the size of the septum and the dimensions in the left atrium are taken into consideration when selecting the size of the device. © 2009 Wiley-Liss, Inc. [source] High-frequency vibration for the recanalization of guidewire refractory chronic total coronary occlusions,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 6 2008Klaus Tiroch MD Abstract Background: Recanalization of coronary chronic total occlusions (CTOs) remains a clinical challenge, particularly when standard guidewire attempts fail. Objectives: We sought to determine the safety and efficacy of a novel method that used high-frequency (20 kHz) vibration to fragment occlusive fibrous tissue and facilitate guidewire crossing into the distal vessel. Methods: A total of 125 patients with CTO, who failed at attempts of conventional guidewire recanalization after more than 5 min of fluoroscopy time, were enrolled in the study. The primary efficacy endpoint was the advancement of the CROSSERÔ catheter through the occlusion and attainment of coronary guidewire positioning in the distal coronary lumen. The primary safety endpoint was the occurrence of death, myocardial infarction, clinical perforation, or target vessel revascularization within the first 30 days. Results: The average fluoroscopy time while delivering the CROSSER catheter was 12.4 min. CROSSER-assisted guidewire recanalization was achieved in 76 (60.8%) procedures and a final diameter stenosis <50% was obtained in 68 (54.4%) of cases. Major adverse events occurred in 11 (8.8%) patients, lower than the predefined objective performance criteria. Angina frequency and quality of life were improved in patients with successful guidewire recanalization. Conclusions: We conclude that high-frequency vibration using the CROSSER catheter is a safe and effective therapy for patients with CTO, which are refractory to standard guidewire recanalization. © 2008 Wiley-Liss, Inc. [source] Transcatheter closure of perimembranous ventricular septal defects using the amplatzer membranous VSD occluder: Immediate and midterm results of an international registryCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 4 2006Ralf Holzer MD Abstract Objective: To report the immediate and midterm results of transcatheter closure of perimembranous ventricular septal defect (PmVSD) using the Amplatzer membranous VSD occluder (AMVSD). Methods: Between April 2002 and August 2004, 100 patients underwent an attempt of percutaneous device closure of PmVSD using the AMVSD in 24 international centers. The median age was 9.0 years (0.7,58 years) and the median weight was 27.5 kg (7,121 kg). Results: A device was successfully deployed in 93/100 (93%) patients. Reasons for procedural failure were an increased gradient across the left ventricle outflow tract in one patient, aortic regurgitation in 2 patients, and inability to securely position the device in 4 patients. The median VSD size by TEE was 7.0 mm (1.5,13 mm), median device size 10 mm (4,16 mm) and median fluoroscopy time 22.1 min (8.9,96.0 min). Weight below 10 kg (P = 0.0392), inlet extension of the VSD (P = 0.0139) and aortic cusp prolapse into the VSD (P = 0.0084) were significantly associated with a lower procedural success. Patients have been followed up for a median of 182 days (1,763 days). There were no procedure-related deaths. Complications were encountered in 29/100 (29%) patients, including rhythm or conduction anomalies in 13 patients (two with complete heart block requiring permanent pacemaker implantation), new or increased aortic (9 patients) or tricuspid (9 patients) regurgitation, most of which were classified as trivial or mild. Patients with a weight below 10 kg had a significantly higher incidence of adverse events than patients with a weight above 10 kg (58.3% versus 25.0%, P = 0.0285). Immediately after device release complete closure of the defect was present in 54/93 (58.1%) patients, increasing to 46/55 (83.6%) patients at 6-months follow-up (P = 0.0012). Left ventricle end-diastolic diameter decreased from a median of 44 mm prior to device closure to a median of 39 mm at 6-months postprocedure (P = 0.0015). Conclusion: Closure of PmVSDs using the AMVSD occluder is safe and effective. However, longer follow-up period is warranted prior to the wide spread use of this device. © 2006 Wiley-Liss, Inc. [source] Transcatheter closure of patent ductus arteriosus with Nit-Occlud coilsCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 4 2005Alpay Celiker MD Abstract The detachable coils have been successfully used for transcatheter occlusion of small- to moderate-sized patent ductus arteriosus (PDA). We report our experience regarding the use of the Nit-Occlud coils (NOCs) for transcatheter PDA and major aortopulmonary collateral (MAPCA) occlusion. Single NOCs were used to close PDA in 26 patients, and one small and two large MAPCAs in two patients. Mean age and weight of the patients were 7.7 ± 5.4 years and 20.6 ± 11.6 kg. Mean minimum duct diameter was 2.8 ± 0.8 mm; ampulla, 8.7 ± 2.4 mm; and PDA length, 9.3 ± 4.4 mm. Mean pulmonary artery pressure ranged from 9 to 51 mm Hg and pulmonary/systemic flow ratio from 1.1 to 5.8. Ductal shape was conical in 24 patients. Route of approach was venous in 23 and arterial in 3. Successful coil implantation was achieved in 24/26 (92.3%). Mean procedure and fluoroscopy time were 67.2 ± 22.1 and 14.9 ± 6.5 min. The three MAPCAs were also successfully occluded using NOC Medium and Flex. Postimplantation angiograms revealed no leak in 3, a trace or small leak in 17, and a medium leak in 4 patients. Mean follow-up was 7 ± 5 months. Complete occlusion was achieved in 17/24 (71%) at 24 hr, 19/24 (79%) by 1 month, 13/15 (87%) by 3 months, 14/15 (93%) by 6 months, and 10/11 (90%) by 12 months postprocedure. Hemolysis, late embolization, duct recanalization, and flow disturbances were not observed. Transcatheter occlusion of moderate-sized PDAs and MAPCAs using NOCs seems to offer a safe, simple, and controlled method in pediatric patients. Catheter Cardiovasc Interv 2005 © 2005 Wiley-Liss, Inc. [source] |