Occurrence Of Procedure-related Complications Research Articles

Nidus Compacity Determined by Semi-Automated Segmentation is aStrong Quantitative Predictor of Brain Arterio-Venous Malformation Cure.

Acompact nidus is awell-known feature of good outcome after treatment in brain arteriovenous malformations (bAVM). This item, included in the "Supplementary AVM grading system" by Lawton, is subjectively evaluated on DSA. The present study aimed to assess whether quantitative nidus compacity along with other angio-architectural bAVM features were predictive of angiographic cure or the occurrence of procedure-related complications. Retrospective analysis of 83patients prospectively collected data base between 2003 to 2018 having underwent digital subtraction 3D rotation angiography (3D-RA) for pre-therapeutic assessment of bAVM. Angio-architectural features were analyzed. Nidus compacity was measured with adedicated segmentation tool. Univariate and multivariate analyses were performed to test the association between these factors and complete obliteration or complication. Compacity was the only significant factor associated with complete obliteration in our predictive model using logistic multivariate regression; the area under the curve for compacity predicting complete obliteration was excellent (0.82; 95% CI 0.71-0.90; p < 0.0001). The threshold value maximizing the Youden index was acompacity > 23% (sensitivity 97%; specificity 52%; 95% CI 85.1-99.9; p = 0.055). No angio-architectural factor was associated with the occurrence of acomplication. Nidus high compacity quantitatively measured on 3D-RA, using adedicated segmentation tool is predictive of bAVM cure. Further investigation and prospective studies are warranted to confirm these preliminary results.

Safety, feasibility and success rate of cryoballoon pulmonary vein isolation without pulmonary vein phlebography

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Catheter ablation is an effective therapy for recurrent, symptomatic atrial fibrillation (AF). Recent studies proved significantly lower rates of AF recurrence with catheter cryoballoon (CB) ablation compared to antiarrhythmic drug therapy. Purpose To evaluate the feasibility and success rate of CB pulmonary vein isolation (PVI) without pulmonary venography. Methods We enrolled a total of 200 patients undergoing PVI with CB. Among those 101 participants received pulmonary venography shortly after the transseptal puncture and before introducing the cryoballoon (group 1), the rest did not (group 2). Amount of injected radiocontrast, fluoroscopy time and dose, left atrium (LA) dwell time, procedure time and one year’s recurrence rate of AF were registered. Results Fifty five percent of the patients were male. Mean age of participants was 63 years. No significant difference in age, cardiac risk factors or BMI was noted between the two groups. Likewise, no difference was found regarding the procedure time (115 ± 30 minutes in group 2 vs. 116 ± 40 minutes in group 1). Fluoroscopy time was shorter in group 2 (23.9 ± 7 vs. 25 ± 11 minutes, P= 0,003). Fluoroscopy dose was lower in group 2 (579 ± 405 vs. 3310 ± 2408 µGy.m2 , P&amp;lt;0,001). We injected less radiocontrast during PVI in group 2 patients (41 ± 21 vs. 81 ± 31 ml, P&amp;lt;0,001). LA-dwell time was significantly shorter in procedures without venography (71 ± 26 vs. 82 ± 36 minutes, P=0,014). We observed comparable AF recurrence rates in both groups during follow-up (28% group 2 vs. 26% group 1). Four minor complications were noticed in the group 1 while five minor complications occurred in the group 2. Major complications were not elicited in both groups. Conclusion In our center, CB PVI without pulmonary venography was feasible and safe. It resulted in lower fluoroscopy dose and shorter fluoroscopy time. Amount of injected radiocontrast and LA-dwell time were significantly reduced, without an impact on AF recurrence rate or occurrence of procedure-related complications.

Risk stratification in patients with upper gastrointestinal submucosal tumors undergoing submucosal tunnel endoscopic resection.

A substantial heterogeneity exists in patients with upper gastrointestinal submucosal tumors (SMTs). This study aimed to identify predictors of long procedure time (≥60 min), occurrence of procedure-related complications, and long hospital stay (≥6 days) in patients with SMTs undergoing submucosal tunnel endoscopic resection (STER) and stratify risk based on the predictors. Sixty-six consecutive patients with upper gastrointestinal SMTs undergoing STER between January 2013 and December 2018 were retrospectively included. Binary logistic regression models were developed to identify predictors of outcomes. Receiver operating characteristic (ROC) curves were constructed to evaluate the discrimination of tumor size. Complete resection and en bloc resection of tumor were achieved in 66 (100%) and 64 patients (97%), respectively. Twenty-seven patients (41%) had a long procedure time, 10 (15%) developed STER-related complications, and 17 (26%) had a long hospital stay. On multivariable analysis, tumor size was an independent predictor of long procedure time (OR 1.37, 95% CI 1.13-1.67; p = 0.001), occurrence of complications (OR 1.06, 95% CI 1.01-1.10; p = 0.012), and long hospital stay (OR 1.05, 95% CI 1.01-1.09; p = 0.035). ROC curves identified a tumor of size 25 mm as the best cutoff; those who had a tumor above this value had a 76-fold risk of long procedure time, 8.56-fold risk of occurrence of complications, and 6.35-fold risk of long hospital stay. Patients with a tumor size ≥25 mm had longer procedure time, higher risk of STER-related complications, and longer hospital stay; therefore, they should be classified as a high-risk group.

Combined epicardial and endocardial approach for redo radiofrequency catheter ablation in patients with persistent atrial fibrillation: a randomized clinical trial

An epicardial approach is an effective means to detect and eliminate residual potentials in non-transmural lesions created during prior endocardial ablation. We sought to determine the impact of a combined epicardial and endocardial approach compared with a conventional endocardial approach, on recurrence-free survival after redo ablation. Participants with recurred persistent atrial fibrillation after prior endocardial ablation were randomized (1:1) to undergo treatment with the combined approach (epicardial followed by endocardial ablation) for the treatment group or conventional approach (endocardial ablation only) for the control group. The primary outcome was the time to recurrence of atrial fibrillation or atrial tachycardia following a 90-day blanking period within 12 months after the procedure. The secondary safety outcome was the occurrence of procedure-related complications within 24 h after the procedure. Of 100 randomized participants {median age, 59.0 [(interquartile range (IQR): 53.8-64.3] years, including 16% women, with one prior ablation (IQR: 1-1)}, 93 (93%) completed the trial. Events relevant to the primary outcome occurred in 16 patients in the treatment group and in 21 patients in the control group {Kaplan-Meier estimator percentages, 32 vs. 42%; hazard ratio, 0.71 [95% confidence interval (CI): 0.37-1.37]}. The periprocedural complication rate was lower in the treatment group [2 vs. 16%; odds ratio, 0.11 (95% CI: 0.00-0.87)] with similar achievement of the procedural endpoint in the two groups. In the redo procedure for persistent atrial fibrillation, the combined approach had no significant difference of recurrence-free survival and a lower procedural complication rate compared with the conventional approach.

One-year duplex ultrasound-assessed closure outcomes of percutaneous endovenous microwave ablation for the treatment of varicose veins of the lower limbs.

This study aims to investigate the safety and efficacy of a new device using microwave technology for the endovenous ablation of the great saphenous vein (GSV) causing symptomatic lower limb varicose veins (LLVV). This prospective, single-arm, single-center, cohort study investigated the safety and effectiveness of endovenous microwave ablation for the treatment of symptomatic LLVV. Enrollment period was set between January and December 2020. Primary safety endpoint was the occurrence of procedure-related complications and primary efficacy endpoint was anatomical success defined as the duplex ultrasound (DUS)-proven GSV occlusion at 1year follow-up. Secondary endpoints included 1-year clinical success (CEAP classification improvement), repeat procedures rate due to GSV recanalization, and pain assessment at 24h post treatment. In total, 50 patients (42 female; mean age: 62 ± 12years) with 64 limbs were treated. No procedure-related complications were noted. Technical success was 95.3% (61/64 GSVs), as three cases of GSV recanalization were detected. Clinical success was 100%, as in all cases symptoms improvement by at least one grade according to CEAP classification, was achieved. Mean CEAP grade significantly improved from 3.3 ± 0.72 (median: 3) at baseline to 1.8 ± 0.85 (median: 2) at 1-year (p < 0.0001). There were no repeat procedures due to GSC recanalization. The median 24-h VAS value was 2 (mean: 1.9 ± 1.4). Endovenous microwave ablation was safe and effective for the treatment of varicose veins, achieving high 1-year GSV occlusion rates.

Therapeutic Plasma Exchange: Indications and Outcomes. Single-Center Registry

Introduction: Therapeutic plasma exchange is used to manage immune-mediated diseases as early as 1970th. Nevertheless, the evidence beyond the therapeutic indication is still anecdotal and depends on observational data and national registries from different parts of the world. Aim of the Study: To review the use of therapeutic plasma exchange (TPE) to manage different conditions in the Dubai Hospital-nephrology department and benchmark against standard indications categories by American Society of Apheresis (ASFA) guidelines.&#x0D; Methods: The study included all adult patients who performed TPE in Dubai Hospital during 24 months period from January 2017 until December 2019. Patient demographics, indications, anticoagulation used, the number of sessions, duration of hospitalization, ICU admission, mortality outcome, and occurrence of procedure-related complications were included. &#x0D; Results: During the 24 months, 142 TPE sessions were performed for 33 registered patients (an average of 4.3 sessions/patient). The most common indications for TPE use in our registry were nephrology-related indications in 119 sessions (85%), while non-nephrology indications contributed for 21 sessions (15%). Among Nephrology related Indications, Thrombotic Thrombocytopenic purpura was the most common indication (47.8%), followed by post kidney transplantation (21%), while non-Nephrology-related indications were mainly for pancreatitis with Hypertriglyceridemia (9.2%). Complications arose in 2 sessions (1.4%), and mortality occurred in one (3%) critically ill patient related to non-procedure consequences and the severity of the underlying disease. &#x0D; Conclusion: Our registry data confirm the safety of therapeutic plasma exchange in a professional, well-equipped nephrology setting when used for proper evidence-based indications with a lower rate of morbidity and mortality.

Conscious sedation or local anesthesia during endovascular treatment for acute ischemic stroke.

To investigate the effect of conscious sedation (CS) on functional outcome and complication rates after intra-arterial treatment (IAT) for acute ischemic stroke (AIS) compared to the use of local anesthesia (LA) at the puncture site only. Patients undergoing IAT for AIS with CS or LA in the Erasmus University Medical Center from March 2014 to June 2016 were included for analysis. The primary outcome was the score on the ordinal modified Rankin Scale (mRS). We compared CS to LA by ordinal logistic regression with covariate adjustment using propensity scoring. In 146 AIS patients treated with IAT, use of CS was associated with a shift towards worse mRS scores (odds ratio [OR] 0.4 [95% confidence interval (CI) 0.2-0.7]) compared to LA. Mortality after 90 days was higher in the CS group compared to the LA group (OR 2.3 [95% CI 1.0-5.2]). No differences between groups were noted with regard to procedure duration (8 minutes, β = 6.3 [95% CI -7.4 to 20.0]) or occurrence of procedure-related complications (OR 1.3 [95% CI 0.6-2.7]). CS was associated with poor functional outcome and increased mortality rates compared to LA. Furthermore, CS did not reduce duration of intervention or interventional complications. CS during IAT for AIS is of no benefit if LA is considered safe. This study provides Class II evidence, because of nonrandom allocation, that for patients with AIS undergoing IAT, LA rather than CS improves functional outcome.

Devenir obstétrical après transfusion in utero pour allo-immunisation fœto-maternelle

ObjectiveErythrocyte allo-immunization's rate has decreased but without adapted treatment the prognosis is still poor. The aim of our study was to evaluate the fetal prognosis, the complication's rate and the risk factors of complications of the intrauterine transfusion. MethodsRetrospective study about 37 fetus and 86 intrauterine transfusions between 2001 and 2017. Our main criterion in judging was the occurrence of procedure related complications: premature membrane rupture or premature delivery within seven days from the procedure, chorioamnionitis, abnormal fetal heart rate indicating an emergency ceasarean section within the 24hours from the procedure, in utero death or neonatal death related to the procedure. ResultsThe survival rate was about 88.9% with a severe complication's rate of 5.8% per intrauterine transfusion and 13.5% per pregnancy. Intrauterine transfusions before 18 weeks of pregnancies was a complication risk factor: 50% of complications before 18 weeks vs. 1.3%, P=0.8×10−3. On the contrary, hydrops did not seem to be a complication risk factor (16.7% of complication with hydrops vs. 3.9%, P=0.27). The localisation of the needle insertion, intra-abdominal or placental insertion, had no effect on the fetal prognosis. ConclusionIntrauterine transfusion complications are rare and it enhances the fetal prognosis. However, an early procedure is related to a higher rate of complications.

Retrospective analysis of technical success rate and procedure-related complications of 867 percutaneous CT-guided needle biopsies of lung lesions

To investigate the technical success rate and procedure-related complications of computed tomography (CT)-guided needle biopsy of lung lesions and to identify the factors that are correlated with the occurrence of procedure-related complications. This was a single- institution retrospective study of 867 consecutive CT-guided needle biopsies of lung lesions performed on 772 patients in a tertiary cancer centre. The technical success rate and complications were correlated with patient, lung lesion, and procedure-related variables. The technical success rate was 87.2% and the mortality rate was 0.12%. Of the 867 total biopsies 25.7% were associated with pneumothorax, and 6.5% required chest tube drainage. The haemothorax rate was 1.8%. There was positive correlation between the development of pneumothorax and smaller lesion diameter (p<0.001), longer transparenchymal distance (p<0.001), and prone position (p=0.027). There was positive correlation between the need for chest tube placement and longer transparenchymal distance (p=0.007) and smaller lesion diameter (p=0.018). Lesions in the left lower lobe had the lowest rates of pneumothorax (p=0.008) and chest tube drainage (p=0.018). Patients whose pneumothoraces were diagnosed on the follow-up chest X-ray, but not on the immediate post-procedural CT scan had significantly higher requirement for chest tube drainage (p=0.039). CT-guided lung biopsy has a high rate of technical success and a low rate of major complications. The present study has revealed several variables that can be used to identify high-risk procedures. A post-procedural chest X-ray within hours after the procedure is highly recommended to identify high-risk patients who require chest tube placement.

Complication Risk Factors in Anterior Choroidal Artery Aneurysm Treatment.

The anterior choroidal artery (AChoA) is arare location for intracranial aneurysms. The treatment of these aneurysms may be challenging due to the risk of occlusion of such asmall and eloquent artery as the AChoA. We aimed to evaluate the risk factors for complications in AChoA aneurysm treatment. We retrospectively analyzed 47consecutive AChoA aneurysms in 40patients treated in our institution from 1999 and 2014 by endovascular means (87%) or surgical clipping (13%). Minor (transient or minor neurological deficits) and major complications (severe permanent neurological deficits or death) were systematically recorded. The influence of patient age, sex, aneurysm size, neck size, shape, dome-to-neck ratio and treatment technique on the occurrence of procedure-related complications was evaluated. Of the patients 11 experienced procedure-related complications (5major, 6minor). Aneurysms with multilobed shape were significantly associated with ahigher procedure-related complication rate. There was atendency for higher major procedure-related complication rate in small volume aneurysms. We did not find any association between the other factors analyzed and occurrence of procedure-related complications. Treatment of AChoA aneurysms has an acceptable complication risk. We did not find any significant differences between surgical and endovascular treatment in terms of procedure-related complication rates. Multilobed aneurysms were significantly associated with ahigher procedure-related complication rate.

Abstract 18514: Outcomes of Different Mechanical Circulatory Support (MCS) Devices and Transcatheter Aortic Valve Replacement (TAVR): A National Cross-sectional US Experience

Introduction: The data regarding use of different Mechanical Circulatory Support (MCS) devices in TAVR is limited. The present study was performed to analyze the complications and outcomes of different MCS in TAVR. Methods: The subjects under study were obtained from Nationwide Inpatient Sample (NIS) for the years 2011-12 using ICD-9-CM procedure codes for TAVR and MCS. The use of MCS was divided into Intra-aortic balloon pump (IABP), percutaneous ventricular assist devices (PVADs) including Impella and TandemHeart, Extracorporeal membrane oxygenation (ECMO) and percutaneous cardiopulmonary support and cardiopulmonary bypass (CBP) using ICD-9-CM codes. The incidence of in-hospital mortality and occurrence of procedure related complications were analyzed. Results: Out of total 1794 TAVR procedures, MCS was utilized in 190 (10.6%) procedures. CBP was the most commonly utilized 136 (71.6%) followed by IABP 36 (18.9%), ECMO 14 (7.4%) and 4 (2.1%). In-hospital mortality was highest with use of IABP (36.6%), followed by ECMO (14.3%), CBP (9.6%) and PVAD (0%) with p-value &lt;0.01. The incidence of complications was similar in IABP and PVAD (100% each) followed by ECMO (85.7%) and CBP (59.4%) with p-value &lt;0.01. Conclusion: Being retrospective in design, the present study has no information regarding indications and individual patient related variables in which each of the MCS devices used. Overall, CBP was observed as the most extensive used MCS modality with less mortality (9.6%) and least complications (59.4%).

Corneal collagen crosslinking for keratoconus or corneal ectasia without epithelial debridement.

Corneal collagen crosslinking (CXL) is a relatively new technique to reduce the progression of keratoconus. The technique can be performed with or without complete debridement of the corneal epithelium. We describe a novel intermediate technique involving mechanical disruption of the epithelium, and evaluate its safety and efficacy. The case notes of 128 eyes with progressive keratoconus or iatrogenic corneal ectasia who had undergone CXL using the epithelial disruption technique were retrospectively reviewed. Thin corneas were treated with hypotonic riboflavin. All others were treated with an isotonic solution. Note was made of preoperative and postoperative parameters, including uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), refraction, endothelial cell count, and corneal tomography. Occurrence of procedure-related complications was recorded. Statistical analyses were performed using the paired sample t-test and Wilcoxon signed-rank test, with a level of P<0.05 being accepted as statistically significant. At 12 months, 41.8% of patients treated with isotonic riboflavin had improved UCVA and 29.7% had improved BSCVA. Only 13.4% lost lines of UCVA and 14.9% lost BSCVA. Of the patients treated with hypotonic riboflavin, at 12 months, 75% demonstrated stability of BSCVA and 25% had stable Kmax. In addition, 25% showed improved visual acuity at 12 months, and 58.3% showed regression of their Kmax. Our rate of short-term complications was comparable to studies using complete epithelial removal. CXL with epithelial disruption is a safe and effective treatment for keratoconus or iatrogenic corneal ectasia, and may be better tolerated by patients than the epithelium-off technique.

Potential of cryoballoon as a time-efficient technique in paroxysmal atrial fibrillation ablation: The Waikato experience

currently implanted are single chamber ventricular pacemakers in octogenarian and nonagenarian patients. We aimed to review our local practice of dual vs. single chamber ventricular PM in these patients and assess whether the current pacing guideline is adhered. Methods: We identified patients aged 80 years, who received a first PM at a tertiary hospital for 3-year period (July 2010 to June 2013) and conducted a single centre retrospective observational study. Results: Mean age of patients was 86.1 ( 4.3) and 82.6 ( 2.9) for single (306/356) and dual (50/356) chamber PMs respectively (P <0.05). Within 3 months, PM complications occurred in 34 patients (9.5%) and the rates between the two groups were comparable. At the time of implantation, 185 patients who received a single chamber PM were in sinus rhythm (52%). Compared to dual chamber recipients, these patients tended to be older (86.2 4.3 vs. 82.6 2.9, P <0.05), more likely to have ischaemic heart disease (68 vs. 27, P 0.02), significant valvular heart disease (22 vs. 13, P 0.01) and cognitive impairment (34 vs. 0, P 0.001). They were also more likely to be discharged to a nursing home (17 vs. 1, P <0.01). Conclusion: The utility of dual chamber PMs in this age group remains below expectation. The occurrence of procedure-related complications was not different in the two groups. The presence of older age, multiple co-morbidities, cognitive impairment and residential care likely influenced the decision of type of device implanted.

Usefulness of Dexmedetomidine during Intracerebral Aneurysm Coiling.

ObjectiveGeneral anesthesia is often preferred for endovascular coiling of intracranial aneurysm at most centers. But in the authors' hospital, it is performed under monitored anesthesia care (MAC) using dexmedetomidine. To determine the feasibility and safety of this approach, the authors reviewed our initial experience.MethodsRetrospective data was analyzed from July 2012 to November 2012. We performed coil embolization in 28 cases using this method. Among them, for statistical significance, we analyzed 12 cases in which the procedure time exceeded an hour. Vital signs were analyzed every 10 minutes. Depth of sedation was measured according to the Ramsay sedation scale and frequency of the repeated roadmap image(s) caused by movement of the patient's head during the procedure.ResultsAll procedures were completed without occurrence of procedure related complications. Under MAC using dexmedetomidine, vital signs of the patients were stable, no statistical significance regarding hemodynamic and respiratory parameters was observed between time points (p>0.05). Adequate sedation was achieved. Mean Ramsay sedation scale was 3.67±1.61 (2 to 6). Repeated roadmap image(s) due to patient's factor occurred in only one case. The mean dosage of drug for adequate sedation for the procedure was 0.65±0.12 mcg/kg/hr without loading doses.ConclusionTo the best of my knowledge, this is the first report published in English using the method of monitored anesthesia with dexmedetomidine for intracranial aneurysm coiling. Monitored anesthesia care using dexmedetomidine without loading dose for embolization of intracranial aneurysms appeared to be a safe and effective alternative to general anesthesia.

Internal iliac artery embolization during an endovascular aneurysm repair with detachable interlock microcoils.

ObjectiveThe purpose of this study was to evaluate the effectiveness of detachable interlock microcoils for an embolization of the internal iliac artery during an endovascular aneurysm repair (EVAR).Materials and MethodsA retrospective review was conducted on 40 patients with aortic aneurysms, who had undergone an EVAR between January 2010 and March 2012. Among them, 16 patients were referred for embolization of the internal iliac artery for the prevention of type II endoleaks. Among 16 patients, 13 patients underwent embolization using detachable interlock microcoils during an EVAR. Computed tomographic angiographies and clinical examinations were performed during the follow-up period. Technical success, clinical outcome, and complications were reviewed.ResultsInternal iliac artery embolizations using detachable interlock microcoils were technically successful in all 13 patients, with no occurrence of procedure-related complications. Follow-up imaging was accomplished in the 13 cases. In all cases, type II endoleak was not observed with computed tomographic angiography during the median follow-up of 3 months (range, 1-27 months) and the median clinical follow-up of 12 months (range, 1-27 months). Two of 13 (15%) patients had symptoms of buttock pain, and one patient died due to underlying stomach cancer. No significant clinical symptoms such as bowel ischemia were observed.ConclusionInternal iliac artery embolization during an EVAR using detachable interlock microcoils to prevent type II endoleaks appears safe and effective, although this should be further proven in a larger population.

National Trends in Anterior Cervical Fusion Procedures

Population-based database analysis. To analyze trends in patient- and healthcare-system-related characteristics, utilization and outcomes associated with anterior cervical spine fusions. Anterior cervical decompression and spine fusion (ACDF) is one of the most commonly performed surgical procedures of the spine. However, few data analyzing trends in patient- and healthcare-system-related characteristics, utilization and outcomes exist. Data from 1990 to 2004 collected in the National Hospital Discharge Survey were accessed. ACDF procedures were identified. Five-year periods of interest (POI) were created for temporal analysis and changes in the prevalence and utilization of this procedure as well as in patient- and healthcare-system-related variables were examined. The changes in the occurrence of procedure-related complications were evaluated. An estimated total of 771,932 discharges after ACDF were identified. Temporally, an almost 8-fold increase in total prevalence was accompanied by a similar increase in utilization (23/100.000 civilians/POI to 157/100.000/civilians/POI). The highest increase in utilization was observed in those > or =65 years (28-fold). Average age increased from 47.2 years to 50.5 years over time. Length of hospital stay decreased from 5.17 days to 2.38 days. Overall procedure-related complication rates decreased from 4.6% to 3.03%. The prevalence of hypertension, diabetes mellitus, hypercholesterolemia, obesity, pulmonary, and coronary artery increased over time among patients undergoing ACDF. Despite limitations inherent to secondary analysis of large databases, we identified a number of significant changes in the utilization, demographics, and outcomes associated with ACDF, which can be used to assess the effect of changes in medical care, direct health care resources, and future research. The effect of the increased prevalence of comorbidities on medical practice remains to be evaluated. Further studies are necessary to evaluate causal relationships.

Robotic versus conventional ablation for common-type atrial flutter: A prospective randomized trial to evaluate the effectiveness of remote catheter navigation

Conventional catheter ablation for common-type atrial flutter (AFL) is a widely established therapy but has not been compared with the use of a robotic navigation system (RNS) thus far. The purpose of this study was to investigate the feasibility of a new, nonmagnetic RNS with regard to safety, efficacy, and X-ray exposure to investigator and patient compared with the conventional ablation approach in patients with AFL. Fifty patients (65.7 +/- 9.3 years, 40 male) undergoing de novo catheter ablation for AFL were randomly assigned to conventional or RNS-guided cavotricuspid isthmus (CTI) ablation. Complete bidirectional isthmus block was achieved for all patients without occurrence of procedure-related complications. The fluoroscopy time and the investigator X-ray exposure (8.2 +/- 4.6 vs. 5.8 +/- 3.6, P = .038; and 8.2 +/- 4.6 vs. 1.9 +/- 1.1 minutes, P<.001) as well as the mean radiofrequency (RF) duration and the energy delivered were significantly higher in the conventional than in the RNS group (321.7 +/- 214.6 vs. 496.4 +/- 213.9 seconds, P = .006; 8279 +/- 5767 vs. 16,308 +/- 6870 J, P<.001, respectively). The overall procedure time in the RNS group was significantly longer than in the conventional group (79.2 +/- 30.6 vs. 58.4 +/- 17.7 minutes; P = .04) but significantly decreased comparing the first 10 with the last 10 patients in the RNS group (105.3 +/- 34.8 vs. 60.6 +/- 6.3 minutes; P = .003). Starting ablation during AFL, bidirectional block instantly after termination was observed in 90% of the RNS and 50% of the conventionally treated patients (P = .03). The present study demonstrates the safety and feasibility of RNS for performing CTI ablation in patients with common-type AFL for use in the clinical routine. As a result of the remote navigation, X-ray exposure and RF duration to achieve bidirectional block were significantly decreased and occurred more often immediately after AFL termination. These findings are consistent with increased catheter stability and RF application efficacy using RNS compared with conventional catheter manipulation.

Complications of intrauterine intravascular transfusion for fetal anemia due to maternal red-cell alloimmunization

The purpose of this study was to establish the true procedure-related complication rate of intrauterine transfusion therapy. A cohort study of 254 fetuses treated with 740 intrauterine blood transfusions for red-cell alloimmunization in a single center in the years 1988 to 2001. Our database was searched for perinatal deaths, emergency deliveries, infections, and preterm rupture of membranes associated with intrauterine blood transfusion. Complications were categorized by two independent obstetricians as procedure-related (PR) or not procedure-related (NPR). Logistic regression analysis was used to identify risk factors for complications. Overall survival was 225/254 (89%). Fetal death occurred in 19 cases (7 PR) and neonatal death in 10 cases (5 PR). There were two cases of intrauterine infection with Escherichia coli (both PR) and two other cases of preterm premature rupture of membranes (1 PR) within a week of a procedure. Emergency delivery after a transfusion was performed in 18 pregnancies (15 PR). The total PR complication rate was 3.1%, resulting in an overall PR loss rate of 1.6% per procedure. Arterial puncture, transamniotic cord puncture, refraining from fetal paralysis, and advancing gestational age were associated with the occurrence of PR complications. Our study shows that intrauterine transfusion is a safe procedure, with a relatively low PR perinatal loss rate. Arterial puncture and transamniotic cord needling carry a high risk for serious complications, whereas fetal paralysis improves the safety of the procedure. This information on risks of intrauterine transfusion therapy may help to further improve the safety of intrauterine transfusions. Data on complication rates of intrauterine transfusions are essential in counseling patients.

Device closure of muscular ventricular septal defects using the Amplatzer muscular ventricular septal defect occluder: Immediate and mid-term results of a U.S. registry

ObjectivesWe sought to report the results of a U.S. registry of device closure of congenital muscular ventricular septal defects (VSDs) using the new Amplatzer mVSD occluder (AGA Medical Corp., Golden Valley, Minnesota). BackgroundMuscular VSDs pose a significant surgical challenge with increased morbidity and mortality. MethodsData were prospectively collected from 83 procedures involving 75 patients who underwent an attempt of percutaneous (70 [93.3%] of 75) and/or perventricular (surgical) (6 [8.0%] of 75) device closure of hemodynamically significant muscular VSDs. The patients' median age was 1.4 years (range 0.1 to 54.1 years). Outcome parameters were procedural success, evidence of residual shunts on echocardiography, and occurrence of procedure-related complications. The median follow-up was 211 days (range 1 to 859 days). ResultsThe median size of the primary VSD was 7 mm (range 3 to 16 mm) and in 34 of 78 (43.6%) procedures, patients had multiple VSDs (range 2 to 7). The device was implanted successfully in 72 of 83 (86.7%) procedures. In 17 of 83 (20.5%) procedures, multiple devices were implanted (range 2 to 3). Procedure-related major complications occurred in 8 of 75 (10.7%) patients. Device embolization occurred in two patients and cardiac perforation in one patient. There were two (2.7%) procedure-related deaths. The 24-h postprocedural complete closure rate was 47.2% (34 of 72 patients), increasing to 69.6% (32 of 46 patients) at 6 months and 92.3% (24 of 26 patients) at 12 months. Six patients underwent successful closure using the perventricular surgical (beating heart) approach, with complete closure at day 1 in three patients and trivial/small residual shunts in the remainder of the patients. ConclusionsThe Amplatzer mVSD device (AGA Medical Corp.) offers excellent closure rates and low mortality when used to close congenital muscular VSDs. The device appears to be safe and effective.

Transcatheter closure of postinfarction ventricular septal defects using the new Amplatzer muscular VSD occluder: Results of a U.S. Registry

The objective of this study was to assess the immediate and mid-term results of transcatheter closure of postinfarct muscular ventricular septal defects (VSDs) using the new Amplatzer postinfarct muscular VSD device (PIMVSD). Ventricular septal rupture occurs in 0.2% of myocardial infarcts and remains associated with very high morbidity and mortality. Data were prospectively collected for 18 patients who underwent attempted device closure of postinfarction VSDs between 2000 and 2003. Five patients underwent the closure in the acute phase (within 6 days from the infarct); the remaining patients underwent closure on day 14-95 after the diagnosis of the infarct. Outcome parameters included procedural success, evidence of residual shunts on echocardiography, and occurrence of procedure-related complications. The procedure was successful in deploying a device across the VSD in 16 of 18 patients. The 30-day mortality was 28%. Eleven patients are still alive and have been followed up for a median of 332 days. Two patients required a second procedure to close a residual VSD. At the most recent outpatient follow-up, the VSD was completely closed in two patients, six patients had a trivial or small residual shunt, and two patients had a moderate residual shunt. We conclude that percutaneous device closure of postinfarction VSDs using the Amplatzer PIMVSD occluder appears to be safe and effective. Further trials are required to assess long-term efficacy and compare the results with those of surgical closure.