HRS Clinical Document Development Methodology Manual and Policies: Executive summary.

The Heart Rhythm Society (HRS) has been developing clinical practice documents in collaboration and partnership with other professional medical societies since 1996. The HRS formed a Scientific and Clinical Documents Committee (SCDC) with the sole purpose of managing the development of these documents from conception through publication. The SCDC oversees the process for developing clinical practice documents, with input and approval from the HRS Executive Committee and the Board of Trustees. As of May 2017, the HRS has produced more than 80 publications with other professional organizations. This process manual is produced to publicly and transparently declare the standards by which the HRS develops clinical practice documents, which include clinical practice guidelines, expert consensus statements, scientific statements, clinical competency statements, task force policy statements, and proceedings statements. The foundation for this process is informed by the Institute of Medicine's standards for developing trustworthy clinical practice guidelines; the new criteria from the National Guidelines Clearinghouse, effective June 2014; SCDC member discussions; and a review of guideline policies and methodologies used by other professional organizations.

Insight into the mechanism of failure of the Riata lead under advisory.

BACKGROUND: Cable externalization and insulation abrasion are known to occur with the St Jude Medical Riata leads under advisory. The distribution of these abnormalities and how they relate to clinical presentation have not been well described. OBJECTIVE: In this study, we sought to determine the relationship between structural lead failure and clinical presentation by using the analysis of returned Riata products in Canada. METHODS: The analyses of returned Riata products in Canada were obtained from St Jude Medical, Sylmar, CA. These data were correlated with the clinical presentation of patients just before lead removal from service. RESULTS: As of May 1, 2013, there were 263 returned Riata leads in Canada. Of these, 43 (16.8%) were found to have insulation abrasion that was due to either lead-can or lead-other device interaction (70%) or inside-out abrasion (27.9%). The predilection of lead-to-can abrasion was seen in the Riata 7-F leads (84.2% vs 58.4%; P = .07), while inside-out abrasion was more common in the Riata 8-F leads (37.5% vs 15.8%; P = .12). Electrical abnormalities were frequent (20 of 31 [65.4%]) and most often due to electrical noise (45.2%), although inappropriate shocks were present (25.8%). Death occurred in 1 of 43 (2.3%) of those patients with an insulation defect in the lead-can abrasion group. CONCLUSION: Lead-can abrasion is the most common form of insulation defect in the Riata group of leads under advisory. Management of this group of leads under advisory should not neglect the issue of lead-can abrasion, in addition to detection of cable externalization.

Comparison of outcomes after cardioversion or atrial fibrillation ablation in patients with differing periprocedural anticoagulation regimens.

BACKGROUND: There is a paucity of data that compare traditional vitamin K antagonist (VKA) with novel oral anticoagulant regimens in periprocedural management of cardioversion or ablation of atrial fibrillation (AF). We sought to compare outcomes of use of VKA, dabigatran (DABI), and rivaroxaban (RIVA) anticoagulation around the time of intervention. METHODS: We studied consecutive patients undergoing cardioversion or ablation of AF at our centre from October 2010 to October 2013. There were 3 different anticoagulation groups: warfarin (VKA), DABI, and RIVA. Safety was assessed according to number of strokes, transient ischemic attacks (TIAs), and clinically important and not important bleeding events. RESULTS: Baseline characteristics were well balanced between the groups. Average follow-up was 6 months (± 4 months). A total of 901 patients who underwent cardioversion were studied (VKA [n = 471], DABI [n = 288] and RIVA [n = 141]). In these patients there were no strokes seen during follow-up and 2 TIAs in the DABI group. Bleeding rates were low, with no significant difference between the 3 groups. A total of 680 patients who underwent ablation were studied (VKA [n = 319], DABI [n = 220] and RIVA [n = 171]). There were no strokes reported during follow-up and 3 TIAs: 2 in the VKA group and 1 in the DABI group not resulting in a significant difference between the groups. Bleeding rates were low, with no significant difference between the groups. CONCLUSIONS: Overall, there was a low incidence of adverse events for all anticoagulation regimens. Warfarin, DABI, and RIVA use around the time of the procedure are safe and reasonable options for patients who undergo cardioversion or AF ablation.

Canadian Cardiovascular Society/Canadian Heart Rhythm Society joint position statement on the use of remote monitoring for cardiovascular implantable electronic device follow-up.

Remote monitoring (RM) is a form of telemedicine technology that permits implanted pacemakers and implantable cardioverter-defibrillators to transmit diagnostic information for review by health care professionals without patients needing to visit the device follow-up clinic. A bedside transmitter in the patient's home conveys the device data using standard telecommunication protocol to a protected internet-accessible RM data server, which authorized health care professionals can access at any time using standard web browser software. Evidence indicates it can accelerate identification of clinical events and potential device problems. RM raises important medicolegal issues concerning the protection of a patient's rights and the safeguarding of patient health information related to the collection, storage, and use of patient device information that must be addressed by follow-up centres. This position statement recommends that remote monitoring be available at all device follow-up clinics as an integral part of the standard of care of device patients and also provides helpful advice to centres for the proper design, implementation, and integration of a remote monitoring system into the clinic.

Failure rate of the Riata lead under advisory: a report from the CHRS Device Committee.

BACKGROUND: A unique form of lead failure has been described in the Riata (8-F) and Riata ST (7-F) silicone defibrillation lead degradation of the outer insulation, resulting in the externalization of conductor cables. OBJECTIVE: To assess rates of lead revision due to lead failure in Riata leads affected by the Riata advisory. METHODS: Nineteen implantable cardioverter-defibrillator implant and follow-up centers were surveyed. RESULTS: As of March 1, 2012, there were 5043 known affected leads implanted in Canada. Data on 4358 (86.4%) leads were obtained; 65.3% of these were Riata (8-F) and 32.4% were Riata ST (7-F) leads. The median time from implant to last follow-up was 5 years. Electrical abnormalities were reported in 4.6% of the affected leads; 8.0% of these were found to have concomitant radiographic evidence of externalization. The rate of electrical failure was higher in the 8-F (5.2%) vs 7-F (3.3%) leads (P = .007). Oversensing with or without inappropriate shocks was reported in 39.8% of the leads with confirmed failure. Abnormally high or low impedance values (29.9%) and elevated pacing capture thresholds (43.8%) were frequently reported. One death (0.5%) attributed to lead failure was reported. Among the leads that were replaced, 21% were extracted. Two major complications (1.0%) were attributed to extraction of these leads. CONCLUSIONS: The overall rate of lead failure in the Riata (8-F) and Riata ST (7-F) leads is higher than previously reported by using passive surveillance data. The impact of recent advisories related to these leads is not yet apparent.

Canadian Cardiovascular Society/Canadian Anesthesiologists' Society/Canadian Heart Rhythm Society joint position statement on the perioperative management of patients with implanted pacemakers, defibrillators, and neurostimulating devices.

There are more than 200,000 Canadians living with permanent pacemakers or implantable defibrillators, many of whom will require surgery or invasive procedures each year. They face potential hazards when undergoing surgery; however, with appropriate planning and education of operating room personnel, adverse device-related outcomes should be rare. This joint position statement from the Canadian Cardiovascular Society (CCS) and the Canadian Anesthesiologists' Society (CAS) has been developed as an accessible reference for physicians and surgeons, providing an overview of the key issues for the preoperative, intraoperative, and postoperative care of these patients. The document summarizes the limited published literature in this field, but for most issues, relies heavily on the experience of the cardiologists and anesthesiologists who contributed to this work. This position statement outlines how to obtain information about an individual's type of pacemaker or implantable defibrillator and its programming. It also stresses the importance of determining if a patient is highly pacemaker-dependent and proposes a simple approach for nonelective evaluation of dependency. Although the document provides a comprehensive list of the intraoperative issues facing these patients, there is a focus on electromagnetic interference resulting from electrocautery and practical guidance is given regarding the characteristics of surgery, electrocautery, pacemakers, and defibrillators which are most likely to lead to interference. The document stresses the importance of preoperative consultation and planning to minimize complications. It reviews the relative merits of intraoperative magnet use vs reprogramming of devices and gives examples of situations where one or the other approach is preferable.

Society position statement : Canadian Cardiovascular Society/Canadian Anesthesiologists' Society/Canadian Heart Rhythm Society joint position statement on the perioperative management of patients with implanted pacemakers, defibrillators, and neurostimulating devices.

PURPOSE: There are more than 200,000 Canadians living with permanent pacemakers or implantable defibrillators, many of whom will require surgery or invasive procedures each year. They face potential hazards when undergoing surgery; however, with appropriate planning and education of operating room personnel, adverse device-related outcomes should be rare. This joint position statement from the Canadian Cardiovascular Society (CCS) and the Canadian Anesthesiologists' Society (CAS) has been developed as an accessible reference for physicians and surgeons, providing an overview of the key issues for the preoperative, intraoperative, and postoperative care of these patients. PRINCIPAL FINDINGS: The document summarizes the limited published literature in this field, but for most issues, relies heavily on the experience of the cardiologists and anesthesiologists who contributed to this work. This position statement outlines how to obtain information about an individual's type of pacemaker or implantable defibrillator and its programming. It also stresses the importance of determining if a patient is highly pacemaker-dependent and proposes a simple approach for nonelective evaluation of dependency. Although the document provides a comprehensive list of the intraoperative issues facing these patients, there is a focus on electromagnetic interference resulting from electrocautery and practical guidance is given regarding the characteristics of surgery, electrocautery, pacemakers, and defibrillators which are most likely to lead to interference. CONCLUSIONS: The document stresses the importance of preoperative consultation and planning to minimize complications. It reviews the relative merits of intraoperative magnet use vs reprogramming of devices and gives examples of situations where one or the other approach is preferable.

Relationship between complex fractionated electrograms (CFE) and dominant frequency (DF) sites and prospective assessment of adding DF-guided ablation to pulmonary vein isolation in persistent atrial fibrillation (AF).

BACKGROUND: Sites of high DF are potential targets for AF ablation, but it is unknown if addition of DF ablation can improve procedural outcome. OBJECTIVES: We sought to (1) examine the relationship between DF sites and complex fractionated electrograms (CFE) and (2) prospectively assess the long-term outcome of adding DF ablation to pulmonary vein antral isolation (PVAI) for persistent AF. METHODS: First, 20 patients with persistent AF who underwent previous CFE-guided ablation and who had AF terminate during ablation were studied retrospectively (group I). Bipolar, 8-second electrograms were collected by a circular catheter (288 ± 86 points/map). The EnSite NavX system allows for automated display of both CFE and DF maps. Electrograms with cycle length <120 ms were considered CFE and were compared to DF sites > 8 Hz (direct inverse relationship). Sites of AF termination were related to CFE and DF sites. Based on these observations, 30 different patients (group II) with persistent AF prospectively underwent DF-guided ablation plus PVAI. They were followed every 3 months for 1 year (visit, Holter, ECG). These patients were compared to case-matched controls undergoing PVAI alone (group III). RESULTS: In group I, there was a significant, inverse correlation between DF and CFE values at each point (r =-0.24, P < 0.001). DF surface area was less than CFE area (27 ± 5 cm(2) vs 34 ± 4 cm(2) , P = 0.03). CFE sites overlapped 48 ± 27% with the DF surface area. Nonoverlapping CFE sites were contiguous to DF sites. AF termination occurred where DF and CFE overlapped, and at these sites, DF was always greater than the mean DF for the map. In group II, all DF sites above the mean value were prospectively ablated during AF. AF termination was noted in only 2/30 (7%) patients. After DF ablation, PVAI was performed and termination increased to 4/30 patients (14%). At 1 year, freedom from atrial arrhythmia > 30 seconds occurred in 57% of DF+PVAI compared to 60% in patients receiving PVAI alone (P = 0.18). CONCLUSIONS: DF and CFE regions overlap only about 50%. AF termination retrospectively occurred on overlapping CFE/DF sites where DF was above the mean. However, prospective ablation of DF sites plus PVAI resulted in low AF termination rates, and did not improve 1 year success over PVAI alone.

Clinical predictors of arrhythmia recurrences following pulmonary vein antrum isolation for atrial fibrillation: predicting arrhythmia recurrence post-PVAI.

INTRODUCTION: Pulmonary vein antrum isolation (PVAI) is an accepted treatment for atrial fibrillation (AF) refractory to medical therapy. The purpose of this study was to identify the patient, procedural, and follow-up factors associated with arrhythmia recurrences following PVAI. METHODS AND RESULTS: Clinical data were prospectively collected on all 385 consecutive patients who had 530 PVAI (age 58 ± 11 years, 63% paroxysmal AF-PAF, follow-up 2.8 ± 1.2 years) between February 2004 and March 2009. ECGs were recorded at each follow-up visit with Holter monitoring 1, 3, 6, and 12 months following PVAI and every 6 months thereafter. Recurrences < 3 months post-PVAI were defined as early, 3 months-1 year post-PVAI as late, and > 1 year post-PVAI as very late. Relationship between predictor variables and outcomes was modeled using Cox proportional hazards analysis. Late recurrences occurred in 42% with a lower rate among PAF versus non-PAF patients (39% vs 56%, P = 0.001). Of the 256 patients with ≥ 1-year follow-up, 121 (47%) had no arrhythmia off antiarrhythmic drugs (AADs) 1 year post-PVAI; 36 (30%) of these had a very late recurrence. In multivariate analysis, non-PAF, hypertension, and prior AAD failure predicted recurrence. When entered into the model, early recurrences remained the only predictor of late recurrences. CONCLUSION: Patients with non-PAF, hypertension, and prior failure of multiple AAD were more likely to experience arrhythmia recurrence post-PVAI. Early recurrences were the strongest predictor of late recurrences. Late and very late recurrences following PVAI were common and should be considered when planning long-term AF patient management.

Incidence of very high defibrillation thresholds (DFT) and efficacy of subcutaneous (SQ) array insertion during implantable cardioverter defibrillator (ICD) implantation.

BACKGROUND: The incidence, risk factors, and management of very high defibrillation thresholds (DFTs) during present-day implantable cardioverter defibrillator (ICD) testing are not well known. OBJECTIVES: The purpose of this study was to assess (1) the incidence of very high DFTs and (2) the efficacy/safety of routinely adding a subcutaneous (SQ) array for these patients. METHODS: The study evaluated patients undergoing first-time ICD implantation at Southlake Regional Healthcare Centre from January 2006 to December 2007. All implanted ICDs had a maximal output of 35 J. Patients with DFTs greater than a 10-J safety margin from maximum output were considered to have very high readings and underwent SQ array insertion after other attempts at lowering DFT (group I). These patients were compared with the rest of the patients who had acceptable DFTs (group II) using both univariate and multivariate logistic regression analysis. Outcomes of array insertion were also assessed. RESULTS: A total of 313 patients underwent first-time ICD implantation during the analysis period. Of those, 16 (5.1%) had very high DFTs (group I). By univariate analysis, advanced New York Heart Association class (3 or 4), congestive heart failure hospitalization, non-ischemic cardiomyopathy, amiodarone use, implant of a biventricular device, and highest quartile of left ventricular (LV) chamber enlargement were all significant predictors of very high DFTs (p < 0.05). By multivariate analysis, only amiodarone use [odds ratio (OR) = 10.3, 95% confidence interval (95% CI) = 3.7-32.6] and being in the highest quartile for LV diastolic diameter [OR = 5.4, 95% CI = 1.4-20.8] predicted very high DFT. In all 16 cases, other methods to lower DFT prior to array insertion were attempted but failed for all patients: reversing shock polarity (n = 15), removing the superior vena cava coil (n = 14), reprogramming shock waveform (n = 9), and repositioning right ventricular lead (n = 9). Addition of the array successfully decreased DFT to within safety margin for all patients (33 ± 2 vs 21 ± 5 J, p = 0.02). Complication due to array insertion occurred in one patient (pneumothorax). CONCLUSIONS: Very high DFTs occur in about 5% of patients undergoing ICD implantation and may be predicted by LV dilation and amiodarone use. SQ array insertion reliably corrects this problem over other interventions with a low rate of procedural complication.

Predictors of appropriate implantable cardioverter defibrillator (ICD) therapy in primary prevention patients with ischemic and nonischemic cardiomyopathy.

BACKGROUND: We sought to assess predictors of appropriate implantable cardioverter defibrillator (ICD) therapy in patients receiving primary prevention ICDs. METHODS: Four hundred twenty-one consecutive patients (ischemic and nonischemic) undergoing primary prevention ICD implantation were studied. Patients were grouped based on the presence/absence of appropriate ICD therapy. Summary data and stored electrograms from ICDs were reviewed to determine appropriateness of therapy. Predictors of therapy were assessed by both univariate and multivariate Cox regression analysis. RESULTS: Of 421 primary prevention patients undergoing ICD implantation, 79 (19%) had received appropriate ICD therapies. By univariate comparison, nonsustained ventricular tachycardia (NSVT), male sex, left ventricle diastolic diameter (LVDD), and hypertension were all significant predictors for ICD therapy over a mean follow-up time of 751 +/- 493 days (P

Dofetilide is safe and effective in preventing atrial fibrillation recurrences in patients accepted for catheter ablation.

AIMS: The aim of this study was to assess the safety and efficacy of dofetilide among patients refractory to other anti-arrhythmic drugs (AADs) and accepted for atrial fibrillation (AF) ablation. METHODS AND RESULTS: One hundred and twenty-seven of 454 patients (69% male, 58% paroxysmal, age 60 +/- 10 years, AF duration 8 +/- 7 years) scheduled for AF ablation between February 2004 and May 2008 were treated with dofetilide. Patients had failed 1.9 +/- 1.1 AADs. Anti-arrhythmic drugs were stopped five half-lives before ablation and 3 months for amiodarone. Patients were followed for 15 +/- 7 months with routine and symptom-driven monitoring. Success was defined as no further AF and partial success as a 50% reduction in frequency/duration of AF episodes. Thirty-six patients started dofetilide 158 +/- 167 days before ablation: 9 had no improvement, 16 experienced partial success, 8 had no further AF, and 2 improved enough to forgo ablation. Seventy-one patients started dofetilide immediately following ablation, of which 14 had no improvement, 22 experienced partial success, and 32 had no further AF. Twenty patients started dofetilide 119 +/- 153 days post-ablation, of which four had no improvement, seven experienced partial success, and nine had no further AF. Six patients discontinued dofetilide during initiation for QT prolongation. CONCLUSION: Dofetilide appears safe and effective in preventing AF in patients refractory to other AADs undergoing catheter ablation.

Real-time integration of 2D intracardiac echocardiography and 3D electroanatomical mapping to guide ventricular tachycardia ablation.

BACKGROUND: Ablation of left ventricular tachycardia (LV VT) involves point-by-point reconstruction of the three-dimensional (3D) virtual anatomy. It is time consuming and requires substantial fluoroscopy exposure. Two-dimensional (2D) intracardiac echocardiography (ICE) affords real-time imaging of the cardiac structures. OBJECTIVE: This study sought to evaluate a mapping system integrating ICE with 3D mapping to guide VT ablation. METHODS: Seventeen patients (16 men, 62 +/- 11 years, LV ejection fraction 40% +/- 15%) had ablation of nonidiopathic VT guided using a system integrating 3D mapping and ICE. ICE probe with a location sensor tracked by the mapping system was positioned in the right heart. Endocardial contours traced on gated images of the LV were used to generate a registered 3D map. Regional wall motion abnormalities (WMA) were tagged. RESULTS: 3D maps were created in 26 +/- 8 min, before entering the LV and without fluoroscopy. Maps were built from 23 +/- 7 contours. Regional WMA corresponded to low bipolar voltage (<0.5 mV). Procedure time was 240 +/- 77 min, with fluoroscopy time of 25 +/- 12 min. LV volume by ICE was 172 +/- 119 cm(3) versus 164 +/- 112 cm(3) for the point-by-point maps (P = .5). Scar area by ICE was 33 +/- 32 cm(2) versus 36 +/- 33 cm(2) for voltage mapping (P = .4). At 5 +/- 4 months, 12 patients (71%) were free of VT. CONCLUSION: A system combining 2D ICE and 3D mapping can reconstruct a 3D shell of the LV, including a substrate map based on regional WMA without the need to enter the LV. VT ablation guided using this approach is safe and effective.

Spatial and temporal stability of complex fractionated electrograms in patients with persistent atrial fibrillation over longer time periods: relationship to local electrogram cycle length.

BACKGROUND: Atrial fibrillation (AF) ablation guided by complex fractionated electrograms (CFE) has been described, but the spatial and temporal stability of the electrograms (EGMs) has been questioned. OBJECTIVE: The purpose of this study was to prospectively assess the spatial and temporal stability of CFE in patients with persistent AF. METHODS: Twenty-four patients were studied. For 12 patients, two high-density CFE maps were performed during AF at baseline (0 minute) and 20 minutes later using the EnSite NavX system. Six-second bipolar EGMs were collected throughout the left atrium (LA) using a circular mapping catheter. Automated software measured the time between discrete local EGM deflections yielding a mean local cycle length (CL). EGMs with mean CL <120 ms were considered CFE. The LA was divided into six regions. Spatial distribution of EGMs at 0 and 20 minutes was compared in each region across three different CL ranges (A = 50-120 ms, B = 121-200 ms, C = 200-500 ms). The 0- and 20-minute CFE maps were directly superimposed offline in MATLAB, and the mean CL value for each point that was sampled in both maps was compared in each CL range (A-C). For the other 12 patients, repetitive measurements (1-minute intervals for 5 minutes) of mean CL were obtained at a sample point for each CL range (A-C) in each patient and compared for consistency. RESULTS: A total of 324 +/- 65 points were collected per map. Globally in the LA, the distribution of CLs did not change from 0 to 20 minutes (A: 47.1% vs 45.0%; B: 35.3% vs 36.5%; C: 16.0% vs 16.9%; P = .6). The CL distribution in each of the six regions of the LA also did not change significantly from 0 to 20 minutes. There was no significant change in repetitive CL measures for range A (mean DeltaCL 12 +/- 4 ms, P = .4). However, there was significant variation over 5 minutes for ranges B and C (mean DeltaCL 39 +/- 19 ms and 48 +/- 22 ms, respectively, P <.05 for both). Superimposing maps showed 74.7% point-to-point match for range A, 39.3% for range B, and 14.2% for range C (within 30 ms), with a significant correlation seen only for range A (r = 0.82, P <.001). CONCLUSION: CFE show a high degree of spatial and temporal stability. Greater temporal variation is seen in progressively longer CL regions that are outside of the CFE region of interest.

A prospective, multicenter evaluation of ablating complex fractionated electrograms (CFEs) during atrial fibrillation (AF) identified by an automated mapping algorithm: acute effects on AF and efficacy as an adjuvant strategy.

BACKGROUND: Complex fractionated electrograms (CFEs) are continuous electrograms (EGMs) of very short cycle length (CL) representing substrate for atrial fibrillation (AF) perpetuation. Ablation of CFEs may result in AF slowing, termination, and prevention, but identifying them can be subjective. OBJECTIVE: The purpose of this study was to prospectively assess (1) whether an automated algorithm can identify CFE regions, (2) the acute effects of ablating these regions on AF, and (3) the long-term efficacy as an adjuvant strategy to pulmonary vein antrum isolation (PVAI). METHODS: Thirty-five patients (three centers, 61 +/- 9 years, left atrium [LA] 43 +/- 9 mm, ejection fraction 53% +/- 7%) with symptomatic paroxysmal (n = 21) or persistent (n = 14) AF were studied. A decapolar lasso (2-mm spacing) was used for mapping. A three-dimensional shell of the LA and pulmonary veins (PVs) was created. If not already in AF, AF was induced by burst pacing (with or without isoproterenol). Atrial EGMs during AF were mapped/analyzed using an automated CFE algorithm. The algorithm measures the time between discrete deflections in a local EGM over 5 seconds (based on selectable width and peak-to-peak [>0.03 mV] criteria). The mean CL of the local EGM is projected onto the LA shell as a color-coded display. Regions of CL <120 ms (published criteria) were targeted for ablation/elimination. Atrial fibrillation cycle length (AFCL) and regularity were measured from the CS. After CFE ablation, further ablation was done to achieve complete PVAI. RESULTS: AF was spontaneous (n = 20) or induced (n = 15) in all patients. CFEs were most commonly found along the septum (97%), anterior LA (97%), PV antra (83%), base of appendage (83%), and annulus (71%). CFE ablation alone prolonged the AFCL (171 +/- 27 vs. 304 +/- 41 ms; P = .03) and regularized AF to left/right flutter (AFL) in 74% of patients. CFE ablation terminated AF/AFL in 19 patients (54%)-the other 16 were cardioverted-and AF became noninducible in 77%. CFE ablation alone did not cause PV isolation (0.1 +/- 0.3 PV isolated/patient). After combined CFE and PVAI ablation, the single-procedure, off-drug success rate was 83% (follow-up 13 +/- 4 months) versus 71% in matched controls who had PVAI alone (P = .045). CONCLUSIONS: CFE ablation guided by an automated algorithm resulted in AFCL prolongation, regularization, and noninducibility in most patients. AF terminated in 54% of cases. PVAI with adjuvant CFE ablation has a high efficacy and may be superior to PVAI alone.

Intracardiac ECHO Integration with Three Dimensional Mapping: Role in AF Ablation.

Background: Catheter ablation of atrial fibrillation (AF) is typically guided by 3D mapping. This involves point-by-point reconstruction of the 3D virtual anatomy and may be time consuming and require substantial fluoroscopy exposure. Intracardiac echocardiography (ICE) affords real time imaging of the cardiac structures during mapping and ablation. Methods: Between February and May 2007, 15 patients (100% men, 10 with paroxysmal AF) presenting for AF ablation were offered mapping using a novel system integrating 3D mapping and ICE. A modified ICE probe with a location sensor tracked by the mapping system was positioned in the right atrium (RA). This allowed acquisition of ECG gated images of the left atrium (LA). Endocardial contours were traced on each image and were used to generate a registered 3D map. Results: 3D maps took a mean of 51+/-25 minutes to create, PRIOR to entering the LA and without fluoroscopy. Pulmonary veins and the esophagus were rendered in 3D. A complete map was built from a mean of 46+/-19 contours. Upon instrumentation of the left atrium, the maps were easily distorted if points collected by the mapping catheter were combined with the original map, due to deformation of the left atrial geometry by the relatively stiff ablation catheter. Pulmonary vein antrum isolation was guided by a circular mapping catheter. Since this catheter could not be visualized on the CARTO map, fluoroscopy was used to track its position and the contact between the ablation catheter and the circular mapping catheter. No substantial reduction in fluoroscopy time was thus realized, as expected. At 10+/-1 months of followup, 73% of the patients were in sinus rhythm after the initial three month blanking period. No patient suffered any complications related to the procedure or in follow-up. Conclusions: A mapping system combining ICE and 3D electroanatomical mapping can feasibly reconstruct a 3D shell of the LA and the pulmonary veins without the need to enter the left heart. The map created is sensitive to distortion during point-by-point mapping with the standard ablation catheter.

A novel regional citrate anticoagulation protocol for CRRT using only commercially available solutions.

PURPOSE: To describe a citrate regional anticoagulation (CRA) protocol for patients with acute renal failure and contraindications to heparin who require continuous renal replacement therapy (CRRT), using only commercially available solutions, for units that do not want or cannot prepare extemporaneously made solutions. MATERIALS AND METHODS: Case report and series from a medical/surgical intensive care unit of a university teaching hospital. A CRA protocol was developed by using only commercially available solutions. Five dialysis-specific clinical parameters were identified to allow simplified measurement and control. RESULTS: There was a dramatic improvement of dialysis filter survival in the index patient that was seen in the subsequent patients receiving CRA. This was accompanied by excellent control of the clinical and biochemical parameters as well as nursing acceptance and ownership of the protocol. CONCLUSION: It is possible to provide safe and effective CRA with only commercially available solutions. The protocol is applicable to most patients requiring CRRT.