Predictive value of the PRAETORIAN score for defibrillation test success in patients with subcutaneous ICD: A subanalysis of the PRAETORIAN-DFT trial.

BACKGROUND: The PRAETORIAN score estimates the risk of failure of subcutaneous implantable cardioverter-defibrillator (S-ICD) therapy by using generator and lead positioning on bidirectional chest radiographs. The PRospective randomized compArative trial of subcutanEous implanTable cardiOverter-defibrillatoR ImplANtation with and without DeFibrillation Testing (PRAETORIAN-DFT) investigates whether PRAETORIAN score calculation is noninferior to defibrillation testing (DFT) with regard to first shock efficacy in spontaneous events. OBJECTIVE: This prespecified subanalysis assessed the predictive value of the PRAETORIAN score for defibrillation success in induced ventricular arrhythmias. METHODS: This multicenter investigator-initiated trial randomized 965 patients between DFT and PRAETORIAN score calculation after de novo S-ICD implantation. Successful DFT was defined as conversion of induced ventricular arrhythmia in <5 seconds from shock delivery within 2 attempts. Bidirectional chest radiographs were obtained after implantation. The predictive value of the PRAETORIAN score for DFT success was calculated for patients in the DFT arm. RESULTS: In total, 482 patients were randomized to undergo DFT. Of these patients, 457 (95%) underwent DFT according to protocol, of whom 445 (97%) had successful DFT and 12 (3%) had failed DFT. A PRAETORIAN score of ≥90 had a positive predictive value of 25% for failed DFT, and a PRAETORIAN score of <90 had a negative predictive value of 99% for successful DFT. A PRAETORIAN score of ≥90 was the strongest independent predictor for failed DFT (odds ratio 33.77; confidence interval 6.13-279.95; P < .001). CONCLUSION: A PRAETORIAN score of <90 serves as a reliable indicator for DFT success in patients with S-ICD, and a PRAETORIAN score of ≥90 is a strong predictor for DFT failure.

A real-world experience of subcutaneous and transvenous implantable cardiac defibrillators-comparison with the PRAETORIAN study.

Background: PRAETORIAN is the first randomized controlled trial that demonstrated the noninferiority of subcutaneous ICD (S-ICD) in comparison with transvenous ICD (TV-ICD). We retrospectively reviewed electronic records of patients with ICD implanted over the past 6 years, with the primary objective to compare our real-world single tertiary center experience with the randomized data from the PRAETORIAN study. Methods: Seventy S-ICD patients were compared with 197 TV-ICD patients, from July 2014 to June 2020 retrospectively, over a median period of 1304 days (296-2451 days). Primary composite endpoints included inappropriate shocks and device-related malfunctions. Results: Patients with S-ICD implantation were younger than those who received TV-ICD (mean, 49.7 years vs 63.9 years, p < .001). About 31.4% of S-ICDs were implanted for secondary prevention, and 58.6% of S-ICD patients had ischemic cardiomyopathy (ICM) with a median left ventricular ejection fraction of 32.5% (range: 10-67%). S-ICDs and TV-ICD had statistically similar inappropriate shocks (4.3% vs 4.6%, p = .78), device-related complications (11.4% vs 9.1%, p = .93), and the overall primary endpoints (15.7% vs 13.7%, p = .68). The findings remained the same even after age and gender adjustments and time-dependent analysis. Conclusion: Although single-center experience with a small number of S-ICD patients, results of the PRAETORIAN study has been replicated in our real-world experience of S-ICD and TV-ICD implantations across diverse etiologies, indications, and age groups confirming the comparable performance of S-ICD and TV-ICD when implanted in selected patients.

Materialization of novel composite bio-based active edible film functionalized with essential oils on antimicrobial and antioxidative aspect of chicken nuggets during extended storage.

The present study was aimed to develop Manihot esculenta and Carrageenan bio-based composite active film functionalized with anise, caraway, and nutmeg essential oils (EOs) and to assess the shelf life of chicken nuggets wrapped with the developed film at refrigeration storage. Overall, the Minimum Inhibitory Concentration (MIC) values of the three EOs ranged from 0.4 to 0.8% v/v of which nutmeg EO was found most effective. Incorporation of EOs in the film resulted in significant (P ˂ 0.05) decrease in tensile strength and water activity while elongation at break was significantly (P ˂ 0.05) increased. No significant (P ˃ 0.05) changes in thickness and Water Vapor Transmission Rate (WVTR) were observed. Based on physicomechanical and sensory evaluation, films incorporated with 0.5, 1, and 1% concentration of anise, nutmeg, and caraway EO were selected. Chicken nuggets overwrapped with aforementioned films were stored aerobically at refrigeration temperature (4 ± 1 °C) to evaluate antimicrobial, antioxidant, and sensory characteristics. The result indicated that pH, peroxide, free fatty acid (FFA), and thiobarbituric acide (TBA) value of treatments were significantly (P ˂ 0.05) lower than controls however significantly (P < 0.05) higher DPPH activity was observed in all treatments. The total plate count, psychrophilic count and, yeast and mold count were also significantly (P ˂ 0.01) lower in treatment groups and were within the permissible limits. The treated samples were well acceptable during whole storage period of 15 days. The application of composite, active edible bio-based film was found proficient in confining product quality attributes throughout storage. PRACTICAL APPLICATION: The majority of films used for packaging of meat and meat products are derived from synthetic "plastic" materials. The demerits associated with plastics have eventually led to explore natural alternatives such as edible films. The composite-active bio-based films have a huge potential to be molded for specific film properties based on requirements of product-specific packaging conditions.

Prognosis associated with redo cardiac resynchronization therapy following complete device and lead extraction due to device-related infection.

Aims: An increase in the number of cardiac resynchronization therapy (CRT) device implantations worldwide has led to a consequent increase in the number of infections associated with the device, making extraction of the CRT device inevitable. Redo CRT implantation after treatment and recovery following device extraction is challenging. This study aimed to evaluate the success rate, complications, and long-term prognosis of redo CRT implantation, including the rates of subclavian, cava, and coronary sinus (CS) vein thrombosis as well as re-infection. Methods and results: Between 2007 and 2014, 1712 lead extractions were performed in 537 patients with device-related infection at Heart Center Brandenburg. Of the 537 patients, 125 (23%) underwent CRT device and lead extraction, including extraction of the left ventricular lead from the coronary sinus. Of these 125, 62 (50%) patients underwent redo CRT implantation (mean age, 68 ± 10 years); 34 patients had coronary artery disease (CAD) while 28 had dilated cardiomyopathy (DCM). The mean left ventricular ejection fraction was 27% ± 7%. The mean QRS duration of the left bundle branch block was 158 (range, 147-162) ms, and 25 patients had atrial fibrillation (AF). All these patients were followed up for a median duration of 29.6 (range, 15-43) months. In 53 of the 62 patients (85%), the CRT system was successfully re-implanted; however, the original CS vein could be used again only in 28 (45%) patients. The all-cause mortality rate was 7.1% after 1 year, and it was significantly higher in patients whose N-terminal pro B-type natriuretic peptide level was ≥3,000 pg/mL (P < 0.001), those who were aged ≥64 years (P = 0.028), those who had CAD (P = 0.042) or chronic kidney insufficiency (P = 0.001), those with AF (P = 0.001) and those whose blood cultures were positive for Staphylococcus aureus (P = 0.014). Conclusion: Redo CRT implantation after device extraction owing to device-related infection has a low success rate and shows a higher rate of re-infection than that observed in patients who undergo CRT implantation for the first time. Further, patients whose blood cultures are positive for S. aureus show a particularly poor outcome.

Development of sweet and sour chicken meat spread based on sensory attributes: process optimization using response surface methodology.

Now a day's meat and meat products are not only generating convenience trends; they have been recognized as core of meat industry. Meat spread is a convenience cooked spreadable product prepared with meat and non-meat additives. Response surface methodology was used to investigate the effects of three different levels of honey (10, 15, 20 g), vinegar (2.0, 6.0, 10.0 ml) and tomato powder (0.5, 1.0, 1.5 g) on response variables viz. color/appearance, flavor, spreadability, texture, after taste, adhesiveability, overall acceptability, while standardizing the process of development of sweet and sour chicken meat spread box-behnken experimental design was used in which 17 different runs with 5 trials of three similar centre point. A second order polynomial was fitted to all the response variables and surface plots as well as equations were conducted. All the processing variables significantly affected the response variables either linearly or quadratically whereas the "Lack of Fit" was non-significant relative to the pure error. For optimization, target values were set in the form of ranges of all the processing and response variables. While applying multiple regression analysis, a total of 43 workable solutions was found, out of which the product with 14.28% honey, 5.38% vinegar and 1.39% tomato powder was selected. The responses for color/appearance, flavor, spreadability, texture, after taste, adhesiveability, overall acceptability, were predicted at 7.11, 6.72, 7.00, 6.99, 6.61, 6.94 and 6.79 respectively, with a desirability value of 1.

Unexpectedly High Incidence of Stroke and Left Atrial Appendage Thrombus Formation After Electrical Isolation of the Left Atrial Appendage for the Treatment of Atrial Tachyarrhythmias.

BACKGROUND: Electric left atrial appendage (LAA) isolation (LAAI) may occur during catheter ablation of atrial tachyarrhythmias. Data regarding the risk of thromboembolic events and stroke after LAAI are sparse. This study evaluated the incidence of LAA thrombus formation and thromboembolic events after LAAI. METHODS AND RESULTS: Fifty patients had LAAI (age=71 years; female=56%; CHA2DS2-VASc score before ablation =3 [2;3]). LAAI patients were compared with matched patients with comparable baseline characteristics who underwent atrial fibrillation ablation without LAAI (n=50). Ablation strategies in the LAAI group included pulmonary vein isolation in 50 (100%), left atrial isthmus line in 47 (94%), anterior line in 45 (90%), complex atrial fractionated potentials in 24 (48%), and roofline in 14 (28%) patients. Transesophageal echocardiography was performed during follow-up in 47/50 (94%) patients in the LAAI group and in all patients of the control group. Oral anticoagulation (OAC) independent of CHA2DS2-VASc score was strongly recommended in all patients. During a median follow-up of 6.5 (4-12) months, stroke occurred in 2 patients on OAC and transient ischemic attack in one without OAC in the LAAI group. In the remaining 47 patients, LAA thrombus was identified on transesophageal echocardiography in 10 (21%) patients (OAC=9; no OAC=1). In the control group, no LAA thrombus was detected and no stroke occurred (P<0.001). Stable sinus rhythm was maintained in 32 patients (64%) of the LAAI group after a median follow-up of 6.5 months (4-12), including 17/32 patients on antiarrhythmic drugs. CONCLUSIONS: After LAAI, an unexpectedly high incidence of LAA thrombus formation and stroke was observed despite OAC therapy.

Experience matters: long-term results of pulmonary vein isolation using a robotic navigation system for the treatment of paroxysmal atrial fibrillation.

BACKGROUND: Long-term results after circumferential pulmonary vein isolation (CPVI) for the treatment of paroxysmal atrial fibrillation (PAF) using a robotic navigation system (RNS) have not yet been reported. OBJECTIVE: To evaluate long-term results of patients with PAF after CPVI using RNS. METHODS: In this study, 200 patients (n = 151 (75.5%) male; median age 62.2 (54.7-67.7) years) with PAF were evaluated. In 100 patients, RNS (RN-group) was used for CPVI and compared to 100 manually ablated control patients (MN-group). Radiofrequency was used in conjunction with 3D electroanatomic mapping. Power was limited to 30 watts (W) at the posterior left atrial (LA) wall in the first 49 RNS patients (RN-group-a). After esophageal perforation occurred in one RN-group-a patient, maximum power was reduced to 20 W for the subsequent 51 patients (RN-group-b). RESULTS: After a median follow-up of 2 years, single (77/100 vs 77/100, p = 0.89) and multiple (90/100 vs 93/100, p = 0.29) procedure success rates were comparable between RN-group and MN-group. Single procedure success rate was significantly lower in RN-group-a as compared to RN-group-b (65.3 vs 88.2%, p = 0.047). In RN-group-a patients, procedural times [200 (170-230) vs 152 (132-200) minutes, p < 0.01] and fluoroscopy times [16.6 (12.9-21.6) minutes vs 13.7 (9.5-19) minutes, p = 0.043] were significantly longer compared to RN-group-b patients. CONCLUSION: Long-term success rate after CPVI using RNS was comparable to manual ablation. Despite a lower power limit of 20 W at the posterior LA wall, single procedure success rate was higher in RN-group-b as compared to RN-group-a. Procedure time and fluoroscopy time decreased, whilst success rate increased with increasing experience in the RN-group.

MitraClip in CRT non-responders with severe mitral regurgitation.

BACKGROUND: Severe mitral regurgitation (MR) ≥ 3+ and left ventricular dyssynchrony in heart failure patients are markers of CRT non response. The MitraClip (MC) implantation is a therapy for MR ≥ 3+ in patients with high surgical risk of mitral valve reconstruction. METHODS AND RESULTS: We investigated 42 patients with CRT and MR ≥ 3+ who received an MC device at our center. One and two year mortality rates were compared with the predicted mortality by Seattle Heart Failure Model (SHFM) and meta-analysis global group in chronic heart failure (MAGGIC), using the baseline characteristics of patients at the time of MC implantation. The median time interval between CRT and MC implantation was 20.1 (4.5-43.3) months. In 19 patients we observed a functional regurgitation with normal leaflets and in 23 patients a degenerative mechanism for mitral regurgitation. There was no change in mean QRS duration by biventricular pacing or MC implantation. The use of MC led to significant reductions in: median N-terminal pro-brain natriuretic peptide (NT-proBNP) level (pg/ml) from 3923 to 2636 (p = 0.02), tricuspid regurgitation pressure gradient (TRPG) from 43 to 35 mmHg (p = 0.019) and in left ventricular end-diastolic volume (LVEDV) by MC (p = 0.008). At the 2 year follow-up interval the all-cause mortality was 25%. CONCLUSION: MC implantation leads to an improvement of NT-proBNP level, TRPG and LVEDV in both functional and degenerative MR but does not influence QRS duration. Two year all-cause mortality was 25% and did not differ significantly from that predicted by SHFM and MAGGIC.

In vivo contact force analysis and correlation with tissue impedance during left atrial mapping and catheter ablation of atrial fibrillation.

BACKGROUND: The aim of this study was to evaluate in vivo contact force (CF) and the correlation of CF with impedance during left atrial 3-dimensional electroanatomical mapping and ablation. METHODS AND RESULTS: CF during point-by-point left atrial mapping was assessed in 30 patients undergoing atrial fibrillation ablation. Operators were blinded to the real-time CF data. Data were analyzed according to 11 predefined areas in the left atrial and 6 segments around the ipsilateral pulmonary veins. A total of 3475 mapping and 878 ablation points were analyzed. Median CF during mapping was 14.0g (6.5-26.2; q1-q3), ranging from 5.1g at the ridge to 29.8g at the roof. Median CF at the ridge and mitral isthmus were 5.1g and 6.9g, respectively. Extremely high CF ≥100g was noted in 24 points (0.7%). Median CFs during ablation around the right and left pulmonary veins were 22.8g (12.6-37.9; q1-q3) and 12.3g (6.9-30.2; q1-q3), respectively. The lowest median CFs were recorded at the anterior-superior and anterior-inferior segments of the left pulmonary veins (7.2g and 7.9g). Impedance values during mapping and impedance fall during ablation correlated with the applied CF (R(2)=0.16; P<0.001 and R(2)=0.04; P<0.001) although there was significant overlap. CONCLUSIONS: Excessively high and low CF values can be observed during left atrial mapping and ablation. The low CF obtained at the mitral isthmus and anterior segments of the left pulmonary veins may explain why reconnection after ablation occurs more frequently at these sites. CF and impedance do correlate; however, the impedance for a given CF ranges widely, limiting its use in clinical practice.

Left atrial isthmus line ablation using a remote robotic navigation system: feasibility, efficacy and long-term outcome.

BACKGROUND: Left atrial isthmus (LAI)-ablation in addition to circumferential pulmonary vein isolation (CPVI) may improve outcomes in select patients with atrial fibrillation (AF). However, bidirectional LAI-block is difficult to obtain. No systematic evaluation reporting on the feasibility and efficacy of LAI-ablation using a robotic navigation system (RNS) exists. METHODS AND RESULTS: In this pilot study, CPVI combined with LAI-ablation were performed using a RNS and 3D-mapping system in 42 patients with persistent (n = 24, 57.1 %) or longstanding persistent AF. Ablation was performed using either a 3.5 mm irrigated tip catheter (ITC) with 6 (group-A, n = 16; max. 40 W, contact force 10-40 g) or (after a steam pop occurred in one patient) with a 4 mm ITC with 12 irrigation holes (group-B, n = 26; max. 30 W, contact force 10-30 g). Epicardial ablation was performed manually whenever bidirectional LAI-block could not be obtained with a maximum of 20 endocardial RF-applications. LAI-conduction block was achieved in all patients using RNS; in six patients (14.3 %), additional epicardial ablation was required to achieve LAI-block. A steam pop occurred during LAI-ablation resulting in cardiac tamponade in one patient in group-A. After a median follow-up period of 21 months, arrhythmia recurrence was seen in in 23/42 patients (18 patients with AF and 5 patients with atrial tachycardia) and repeat procedure was performed in 12 (28.6 %) patients; recovered LAI-conduction was found in 5/12 (41.7 %) patients. The RNS-group was compared to a historical group of 20 patients with manual LAI-ablation. Using RNS, LAI-block was more often achieved (42 (100 %) vs 16 (80 %), p < 0.01) and epicardial ablation was required in a significantly smaller number of patients (6 (14.3) vs 10 (50 %), p < 0.01). CONCLUSIONS: LAI-ablation using RNS appears to be feasible in all patients. At repeat procedure, LAI-conduction can frequently occur; power and contact-force adaption appears to be mandatory to reduce the risk of complications. Using RNS, instead of a manual approach for LAI-line ablation may facilitate creation of a bidirectional LAI-block.

Catheter ablation of long-standing persistent atrial fibrillation: 5-year outcomes of the Hamburg Sequential Ablation Strategy.

OBJECTIVES: This study describes the 5-year efficacy of catheter ablation for long-standing persistent atrial fibrillation (LS-AF). BACKGROUND: Long-term outcome data after catheter ablation for LS-AF are limited. METHODS: Long-term follow-up of 56 months (range 49 to 67 months) was performed in 202 patients (age 61 ± 9 years) who underwent the sequential ablation strategy for symptomatic LS-AF. Initial ablation strategy was circumferential pulmonary vein isolation (PVI). Additional ablation was performed only in acute PVI nonresponder, if direct current cardioversion failed after PVI. RESULTS: After the first ablation procedure, sinus rhythm was documented in 41 of 202 (20.3%) patients. After multiple procedures, sinus rhythm was maintained in 91 of 202 (45.0%) patients, including 24 patients receiving antiarrhythmic drugs. In 105 patients, PVI was the sole ablative therapy, 49 (46.7%) of those patients remained in sinus rhythm during follow-up. Patients with a total AF duration of <2 years had a significantly higher ablation success rate than patients whose AF duration was >2 years (76.5% vs. 42.2%, respectively; p = 0.033). Persistent AF duration (hazard ratio: 1.09 [95% confidence interval: 1.04 to 1.13]; p < 0.001) independently predicted arrhythmia recurrences, and acute PVI responders had a reduced risk of relapse (hazard ratio: 0.57 [95% confidence interval: 0.41 to 0.78]; p < 0.001) after the first ablation. CONCLUSIONS: During 5-year follow-up, single- and multiple ablation procedure success was 20% and 45%, respectively, for patients with LS-AF. For patients with a total AF duration of <2 years, the outcomes were favorable.

Incidence and long-term follow-up of silent cerebral lesions after pulmonary vein isolation using a remote robotic navigation system as compared with manual ablation.

BACKGROUND: The incidence of silent cerebral lesions (SCL) after atrial fibrillation (AF) ablation is highly variable, depending on the technology used. Recently, an increased risk for SCL has been described for a novel, nonirrigated ablation tool using multielectrode phased radiofrequency (PVAC). The aim of this prospective study was to evaluate the incidence and long-term follow-up of SCL in patients undergoing robotically assisted pulmonary vein isolation (RA-PVI) as compared with manual PVI. METHODS AND RESULTS: Circumferential PVI using irrigated radiofrequency current was performed on 70 patients (41 patients with paroxysmal AF, 59%). Fifty patients underwent RA-PVI and 20 patients underwent a manual approach. Cerebral MRI was performed the day before and the day after the ablation procedure; follow-up MRI was performed on 9 of 12 (75%) patients after a follow-up period of 21 months. SCLs were found in 12 of 70 (17%) patients in this study; the incidence of SCLs was similar in patients undergoing RA-PVI as compared with manually ablated patients (n=9, 18% versus n=3, 15%; probability value=1.0). In 1 patient undergoing manual PVI (1%), an SCL with asymptomatic subarachnoid hemorrhage was detected; the bleeding completely resolved within 1 month. Transient ischemic attack occurred in 1 (1%) patient 2 days after manual PVI. After a median follow-up period of 21 months, no residual SCLs were detected. CONCLUSIONS: The incidence of SCL using the robotic navigation system was 18% in this study. Incidence and size of SCL appears to be similar after RA-PVI as compared with manual PVI. Repeat MRI showed no residual SCLs at long-term follow-up.

The relationship between right ventricular pacing and atrial fibrillation burden and disease progression in patients with paroxysmal atrial fibrillation: the long-MinVPACE study.

AIMS: In patients requiring permanent pacemaker implantation for sinus node disease (SND) or atrioventricular (AV) block, right ventricular (RV) pacing has been demonstrated to increase the risk of developing atrial fibrillation (AF). The effects of RV pacing in patients with paroxysmal AF are less well defined. Short- and medium-term studies have suggested no significant correlation between RV pacing and atrial fibrillation burden (AFB) measurement; we sought to assess for an effect in the long-term. METHODS AND RESULTS: Sixty-six patients were randomized to receive either conventional dual chamber pacing (DDDR, n = 33), or dual chamber minimal ventricular pacing (MinVP, n = 33), for a period of at least 1 year. Patients were reviewed every 6 months and all pacemaker data were downloaded. The primary outcome measures were device-derived AFB and progression to persistent AF. The mean duration of study follow-up was 1.4 ± 0.6 years. Mean ventricular pacing was less in the MinVP cohort compared with the DDDR cohort (5.8 vs. 74.0%, P < 0.001). At follow-up, the device-derived AFB was significantly lower in the MinVP cohort when compared with the DDDR cohort (12.8 ± 15.3% vs. DDDR 47.6 ± 42.2%, P < 0.001). Kaplan-Meier estimates of time to onset of persistent AF showed significant reductions in the rates of persistent AF for MinVP pacing (9%) when compared with conventional DDDR pacing (42%), P = 0.004. CONCLUSION: Right ventricular pacing induces increased AFB in patients with paroxysmal AF in the long term. Dual chamber MinVP algorithms result in reduced AFB and reduced disease progression from paroxysmal to persistent AF in the long term.

The usefulness of minimal ventricular pacing and preventive AF algorithms in the treatment of PAF: the 'MinVPace' study.

INTRODUCTION: The beneficial effects of atrial pacing on the incidence, duration and symptomatology of paroxysmal atrial fibrillation (PAF) may be negated by increased ventricular pacing. This prospective randomised study evaluates the effect of pacing algorithms that minimise ventricular pacing (MinVP) with and without anti-AF algorithms, on AF burden (AFB) in patients with symptomatic PAF. METHODS: Patients implanted with pacemakers with MinVP capability with AFB 1-70% were enrolled. Three different DDDRP devices were assessed. Following a 1-month induction phase, patients were randomised to MinVP with and without preventive AF algorithms or dual chamber rate adaptive pacemaker (DDDR) (AV delay (AVD) 150 ms) for 2 months per study phase. The primary outcome measure was AFB. RESULTS: One hundred and ten patients were enrolled; of these, 66 (mean age 74.3 + or - 7.9, 56% males) had an AFB of 1-70% during the induction phase and completed all study phases. There was no significant difference in AFB between the control phase DDDR, 13.8% (95% CI 8.7 to 18.8), and MinVP, 14.4% (95% CI 9.4 to 19.4), or MinVP with AF algorithms enabled, 14.7% (95% CI 9.7 to 19.7), (p = 0.65 and p = 0.49, respectively). Median ventricular pacing was significantly higher during the control phase, 86.0% (IQR 72.8, 97.3), than in MinVP 2.0% (IQR 0.0, 14.1) and MinVP + algorithms 3.0% (IQR 0.4, 15.6), p = < 0.001. CONCLUSION: MinVP algorithms are effective in reducing ventricular pacing. However, there is no significant reduction in AFB with minimal ventricular pacing algorithms in the short term. No additional benefit or adverse outcome was found with preventative anti-AF algorithms in combination with MinVP algorithms.

The effect of bipole tip-to-ring distance in atrial electrodes upon atrial tachyarrhythmia sensing capability in modern dual-chamber pacemakers.

INTRODUCTION: Accurate atrial arrhythmia discrimination is important for dual chamber pacemakers and defibrillators. The aim was to assess the accuracy of atrial arrhythmia recording using modern devices and relate this to atrial tip-to-ring (TTR) distance. METHODS: One hundred eighty-two patients (72 + or - 9 years, 55% male) with paroxysmal atrial fibrillation were enrolled and were included in the study if they had an atrial fibrillation (AF) burden of 1-50% during a monitoring phase. Seventy-nine patients fulfilled these criteria and were followed for at least 5 months. Electrodes were classified as having short (<10 mm), medium (10-12), or long (13-18) atrial TTR spacing. RESULTS: Two thousand eight hundred eighty-three detailed onset reports were analyzed; 730 (25%) demonstrated aberrant sensing. Six percent were due to farfield R wave oversensing (FFRWO) and 19% due to undersensing, sometimes occurring in the same patient and study phase. FFRWO was significantly reduced with short TTR electrodes (P < 0.05). Undersensing due to sensitivity fallout was 18% (short), 24% (medium), and 17% (long) (P = ns). Undersensing due to pacemaker blanking was 11% (short), 11% (medium), and 12% (long) (P = ns). Active fixation electrodes did not show any difference from passive fixation. CONCLUSION: Atrial electrodes with a short TTR (<10 mm) significantly reduce FFRWO without increasing undersensing and should be used routinely in patients with paroxysmal atrial tachyarrhythmias. However, 20% of atrial tachyarrythmia episodes were incorrectly classified as terminated by these modern devices due to undersensing. Clinicians should be wary of using device-derived endpoints that rely on AF episode number or duration as these may be falsely increased or reduced, respectively.

Relationship of indices of inflammation and thrombogenesis to arrhythmia burden in paroxysmal atrial fibrillation.

BACKGROUND: Atrial fibrillation (AF) is associated with a high risk of stroke. The contribution of arrhythmia to events is clear in sustained forms of AF, but in paroxysmal AF, presently available data have yet to identify what proportion of time spent in AF (ie, arrhythmia burden [AFB]) is of clinical relevance. We aimed to assess this relationship using surrogate blood markers for the hypercoagulable state associated with AF. METHODS: One hundred twenty-one consecutive outpatients (mean age 74.7 +/- 7.8 years; 73 [60.3%] men) with pacemakers capable of arrhythmia detection were recruited. AFB was assessed over a 1-month period and classified as AFB = 0%, 0.1% to 10%, 10.1% to 50%, or > 50%. RESULTS: Baseline characteristics and comorbidities were comparable between groups. There were no significant differences in levels of soluble E-selectin (sE-selectin), von Willebrand factor (vWf), high-sensitivity C-reactive protein, interleukin-6, soluble P-selectin (sP-selectin), or tissue factor (TF) across the four patient groups. Levels of plasma brain natriuretic peptide (BNP) were approximately twofold greater in the group with the highest AFB (P < .001). Following a stepwise multiple linear regression analysis, age was a significant predictor of vWf (P = .010), sP-selectin (P = .042), and BNP (P = .012). Left ventricular fractional shortening was predictive of BNP (P = .001) and sE-selectin (P = .012). Anticoagulation was a predictor of vWf levels (P = .005), and hypertension was predictive of TF (P < .001). CONCLUSION: Given no appreciable difference in levels of prothrombotic markers in relation to AFB in this study, it is plausible that these abnormalities do, in fact, relate to underlying risk factors, and that such patients should be anticoagulated if risk factors dictate. Thus, AFB per se should probably not influence the decision to anticoagulate, but rather the presence of AF combined with clinical risk scoring should remain the predominant tool for stroke risk assessment.

The relationship between high-frequency right ventricular pacing and paroxysmal atrial fibrillation burden.

AIMS: Right ventricular pacing increases the risk of persistent atrial fibrillation (AF) in the long term. The effects of right ventricular pacing on paroxysmal AF (PAF) are unknown. The aim was to examine the effect of right ventricular pacing on AF burden (AFB) in patients with symptomatic drug-resistant PAF. Pooled analysis of pacemaker-derived counters and AF diagnostic data from the Atrial Fibrillation Therapy (AFT) and Pacemaker Atrial Fibrillation Suppression (PAFS) randomized anti-AF pacemaker algorithm trials were used. METHODS AND RESULTS: Five hundred and fifty-four patients from the AFT (n = 372) and PAFS (n = 182) were studied. The individual percentages of pacing, Atrial Sense Ventricular Pace (ASVP), Atrial Pace Ventricular Pace (APVP), and Atrial Pace Ventricular Sense (APVS) as well as total ventricular pacing during synchronous rhythm (VPinSR, %) were examined for an effect on AFB. Three hundred and twenty-one (AFT, age 64 +/- 11, 55% male) and 79 (PAFS, age 71 +/- 8, 54% male) patients had complete data for analysis. Increased VPinSR was weakly associated with an increased AFB (effect size-10% VPinSR increased AFB by only 0.03%) in AFT (P = 0.04) but not PAFS (P = 0.98) or the pooled analysis (P = 0.95). None of the synchronous paced modalities (ASVP, APVP, APVS) significantly increased AFB compared with sinus rhythm (Atrial Sense Ventricular Sense) (P = ns). CONCLUSION: No pacing modality, atrial or ventricular, had a significant effect on AFB. On the basis of these data, the detrimental effect of high-frequency right ventricular pacing on AFB in paced PAF patients, unlike with persistent AF, appears to be minimal in the short term.

A preliminary assessment of the effects of ATI-2042 in subjects with paroxysmal atrial fibrillation using implanted pacemaker methodology.

AIMS: ATI-2042 (budiodarone) is a chemical analogue of amiodarone with a half life of 7 h. It is electrophysiologically similar to amiodarone, but may not have metabolic and interaction side effects. The sophisticated electrocardiograph logs of advanced DDDRP pacemakers were used to monitor the efficacy of ATI-2042. The aim of this study was to determine the preliminary efficacy and safety of ATI-2042 in patients with paroxsymal atrial fibrillation (PAF) and pacemakers. METHODS AND RESULTS: Six women with AF burden (AFB) between 1 and 50% underwent six sequential 2-week study periods. Patients received 200 mg bid of ATI-2042 during Period 2 (p2), 400 mg bid during p3, 600 mg bid during p4, 800 mg bid during p5, and no drug during baseline and washout (p1 and p6). Pacemaker data for the primary outcome measure AFB were downloaded during each period. Mean AFB decreased between baseline and all doses: AFB at baseline (SD) was 20.3 +/- 14.6% and mean AFB at 200 mg bid was 5.2 +/- 4.2%, at 400 mg bid 5.2 +/- 5.2%, at 600 mg bid 2.8 +/- 3.4%, and at 800 mg bid 1.5 +/- 0.5%. The mean reductions in AFB at all doses of ATI-2042 were statistically significant (P < 0.005). Atrial fibrillation burden increased in washout. Atrial fibrillation episodes tended to increase with ATI-2042, but this was offset by substantial decreases in episode duration. ATI-2042 was generally well tolerated. CONCLUSION: ATI-2042 effectively reduced AFB over all doses studied by reducing mean episode duration. A large-scale study will be required to confirm this effect.