Behavior of AV synchrony pacing mode in a leadless pacemaker during variable AV conduction and arrhythmias.

INTRODUCTION: MARVEL 2 assessed the efficacy of mechanical atrial sensing by a ventricular leadless pacemaker, enabling a VDD pacing mode. The behavior of the enhanced MARVEL 2 algorithm during variable atrio-ventricular conduction (AVC) and/or arrhythmias has not been characterized and is the focus of this study. METHODS: Of the 75 patients enrolled in the MARVEL 2 study, 73 had a rhythm assessment and were included in the analysis. The enhanced MARVEL 2 algorithm included a mode-switching algorithm that automatically switches between VDD and ventricular only antibradycardia pacing (VVI)-40 depending upon AVC status. RESULTS: Forty-two patients (58%) had persistent third degree AV block (AVB), 18 (25%) had 1:1 AVC, 5 (7%) had variable AVC status, and 8 (11%) had atrial arrhythmias. Among the 42 patients with persistent third degree AVB, the median ventricular pacing (VP) percentage was 99.9% compared to 0.2% among those with 1:1 AVC. As AVC status changed, the algorithm switched to VDD when the ventricular rate dropped less than 40 bpm. During atrial fibrillation (AF) with ventricular response greater than 40 bpm, VVI-40 mode was maintained. No pauses longer than 1500 ms were observed. Frequent ventricular premature beats reduced the percentage of AV synchrony. During AF, the atrial signal was of low amplitude and there was infrequent sensing. CONCLUSION: The mode switching algorithm reduced VP in patients with 1:1 AVC and appropriately switched to VDD during AV block. No pacing safety issues were observed during arrhythmias.

Clinical safety and performance of a MRI conditional pacing system in patients undergoing cardiac MRI.

BACKGROUND: Utilization of cardiac magnetic resonance imaging (cMRI) as an imaging modality in clinical practice is rapidly increasing. More evidence from randomized studies establishing clinical safety and performance of pacing systems in patients undergoing a cMRI scan is needed. OBJECTIVES: The purpose of this prospective, multicenter, randomized study was to demonstrate safety and efficacy of the Accent MRI™ conditional pacing systems (St. Jude Medical, St. Paul, MN, USA) in patients undergoing cMRI scan. METHODS: Patients (n  =  283) indicated for dual-chamber pacemaker implant were randomized to either the MRI Group (MG) (n  =  140) or the Control Group (CG) (n  =  143) after successful device implantation of the Accent MRI™ system. Clinical evaluation and device interrogation were performed at pre- and post-MRI scan, and 1 month post-MRI for all patients. At 9-12 weeks postimplant, patients in MG underwent a nondiagnostic cMRI scan at 1.5 Tesla (T), while patients in CG underwent device interrogation and clinical evaluation twice with a 45-minute waiting period in between. The safety endpoint was freedom from MRI scan-related complications and that for efficacy was significant changes in right atrial/ventricular capture threshold and sensing amplitude between right before MRI, immediately after MRI, and 1 month post-MRI. RESULTS: Results showed 100% freedom from MRI scan-related complications. There were no significant changes in device performance between pre-MRI scan and 1 month post-MRI scan time points in both study groups. CONCLUSIONS: cMRI scanning with 1.5 T scanners is safe in patients implanted with the Accent MRI™ conditional pacing system and has no significant effect on the electrical parameters of the device and leads.

Early LAAO device migration after combined atrial fibrillation ablation and left atrial appendage occlusion.

The combined procedure of catheter ablation and percutaneous left atrial appendage occlusion for patients with atrial fibrillation has been shown to be safe and feasible using radiofrequency energy or cryoballoon.

Synergistic Coronary Artery Calcium Modification With Combined Atherectomy and Intravascular Lithotripsy.

BACKGROUND: Severe coronary artery calcification (CAC) remains challenging during percutaneous coronary intervention (PCI) and often requires 1 or more advanced calcium modification tools. OBJECTIVES: We describe the combination use of rotational (RA) or orbital atherectomy (OA), with intravascular lithotripsy (IVL), termed rotatripsy and orbital-tripsy, respectively, for modifying CAC prior to stent implantation during PCI. METHODS: We performed a retrospective analysis of patients treated with rotatripsy or orbital-tripsy at our center between July 2019 and March 2022. The primary efficacy endpoint was procedural success (successful stent implantation, <30% residual stenosis visually, Thrombolysis in Myocardial Infarction 3 flow; absence of types C to F dissection/perforation or loss of side branch ≥2.0mm visually) without in-hospital major adverse cardiovascular event (MACE, defined as cardiovascular death, myocardial infarction [MI], target-vessel revascularization). RESULTS: A total of 25 patients (14 rotatripsy and 11 orbital-tripsy) were included in our study. The mean age was 72.2 ± 7.6 years and 76% were men. PCI was guided by intravascular imaging in 24 patients (96%). All cases were treated with either RA or OA before utilization of IVL. Procedural success was achieved in 22 cases (88%) with 1 sidebranch loss without periprocedural MI (4%) and 2 in-patient deaths (8%) unrelated to the procedure (1 intracerebral hemorrhage and 1 cardiac arrest). CONCLUSION: We describe efficacious use of both rotatripsy and orbital-tripsy to modify severe CAC during PCI in a real-world setting. Intravascular imaging can guide appropriate use of these devices to complement each other to modify severe CAC to achieve optimal outcomes.

Biventricular pacing in patients with bradycardia and normal ejection fraction.

BACKGROUND: Observational studies suggest that conventional right ventricular apical pacing may have a deleterious effect on left ventricular function. In this study, we examined whether biventricular pacing is superior to right ventricular apical pacing in preventing deterioration of left ventricular systolic function and cardiac remodeling in patients with bradycardia and a normal ejection fraction. METHODS: In this prospective, double-blind, multicenter study, we randomly assigned 177 patients in whom a biventricular pacemaker had been successfully implanted to receive biventricular pacing (89 patients) or right ventricular apical pacing (88 patients). The primary end points were the left ventricular ejection fraction and left ventricular end-systolic volume at 12 months. RESULTS: At 12 months, the mean left ventricular ejection fraction was significantly lower in the right-ventricular-pacing group than in the biventricular-pacing group (54.8+/-9.1% vs. 62.2+/-7.0%, P<0.001), with an absolute difference of 7.4 percentage points, whereas the left ventricular end-systolic volume was significantly higher in the right-ventricular-pacing group than in the biventricular-pacing group (35.7+/-16.3 ml vs. 27.6+/-10.4 ml, P<0.001), with a relative difference between the groups in the change from baseline of 25% (P<0.001). The deleterious effect of right ventricular apical pacing occurred in prespecified subgroups, including patients with and patients without preexisting left ventricular diastolic dysfunction. Eight patients in the right-ventricular-pacing group (9%) and one in the biventricular-pacing group (1%) had ejection fractions of less than 45% (P=0.02). There was one death in the right-ventricular-pacing group, and six patients in the right-ventricular-pacing group and five in the biventricular-pacing group were hospitalized for heart failure (P=0.74). CONCLUSIONS: In patients with normal systolic function, conventional right ventricular apical pacing resulted in adverse left ventricular remodeling and in a reduction in the left ventricular ejection fraction; these effects were prevented by biventricular pacing. (Centre for Clinical Trials number, CUHK_CCT00037.)

Acute effects of right ventricular apical pacing on left atrial remodeling and function.

BACKGROUND: The acute effects of right ventricular apical (RVA) pacing on left atrial (LA) function in patients with normal ejection fraction are not clear. METHODS: A total of 94 patients (age 68.1 ± 11.1 years, 26 men) with implanted RVA-based dual-chamber pacemakers were recruited into this study. Patients who were pacemaker-dependent, in persistent atrial fibrillation or left ventricular ejection fraction <45% were excluded. Echocardiography (iE33, Philips, Andover, MA, USA) was performed during intrinsic ventricular conduction (V-sense) and RVA pacing (V-pace) with 15 minutes between switching modes. The total maximal LA volume (LAV(max)), preatrial contraction volume (LAV(pre)), and minimal volume (LAV(min)) were assessed by area-length method. Peak systolic, early diastolic, and peak late diastolic (atrial contractile) velocity (Sm-la, Em-la, and Am-la) and strain (ɛs-la, ɛe-la, and ɛa-la) were measured by color-coded tissue Doppler imaging (TDI) in four mid-LA walls at apical four- and two-chamber views. RESULTS: During V-pace, LA volumes increased significantly compared with V-sense (LAV(max): 52.0 ± 18.8 vs 55.2 ± 21.1 mL, P = 0.005; LAV(pre): 39.8 ± 16.4 vs 41.3 ± 16.6 mL, P = 0.014; LAV(min): 27.4 ± 14.0 vs 29.1 ± 15.1 mL, P = 0.001). TDI parameters showed significant reduction in Sm-la and Em-la. Furthermore, ɛs-la, ɛe-la, and ɛa-la decreased significantly, especially in patients with preexisting diastolic dysfunction (all P < 0.01). CONCLUSIONS: RVA pacing acutely induced LA enlargement and impaired atrial contractility. Patients with preexisting diastolic dysfunction may be more vulnerable to develop LA dysfunction and remodeling after acute RVA pacing.

Biventricular pacing is superior to right ventricular pacing in bradycardia patients with preserved systolic function: 2-year results of the PACE trial.

AIMS: The Pacing to Avoid Cardiac Enlargement (PACE) trial is a prospective, double-blinded, randomized, multicentre study that reported the superiority of biventricular (BiV) pacing to right ventricular apical (RVA) pacing in the prevention of left ventricular (LV) adverse remodelling and deterioration of systolic function at 1 year. In the current analysis, we report the results at extended 2-year follow-up for changes in LV function and remodelling. METHODS AND RESULTS: Patients (n = 177) with bradycardia and preserved LV ejection fraction (EF ≥45%) were randomized to receive RVA or BiV pacing. The co-primary endpoints were LVEF and LV end-systolic volume (LVESV). Eighty-one (92%) of 88 in the RVA pacing group and 82 (92%) of 89 patients in the BiV pacing group completed 2-year follow-up with a valid echocardiography. In the RVA pacing group, LVEF further decreased from the first to the second year, but it remained unchanged in the BiV pacing group, leading to a significant difference of 9.9 percentage points between groups at 2-year follow-up (P < 0.001). Similarly, LVESV continues to enlarge from the first to the second year in the RVA pacing group, leading to a difference of 13.0 mL (P < 0.001) between groups. Predefined subgroup analysis showed consistent results with the whole study population for both co-primary endpoints, which included patients with pre-existing LV diastolic dysfunction. Eighteen patients in the BiV pacing group (20.2%) and 55 in the RVA pacing group (62.5%) had a significant reduction of LVEF (of ≥5%, P < 0.001). CONCLUSION: Left ventricular adverse remodelling and deterioration of systolic function continues at the second year after RVA pacing. This deterioration is prevented by BiV pacing.

Primary results from the Japanese Heart Failure and Sudden Cardiac Death Prevention Trial (HINODE).

AIMS: The HINODE study aimed to analyse rates of mortality, appropriately treated ventricular arrhythmias (VA), and heart failure in Japanese patients and compared with those in Western patients. METHODS AND RESULTS: After treatment decisions following contemporary practice in Japan, patients were prospectively enrolled into four cohorts: (i) internal cardioverter-defibrillator (ICD), (ii) cardiac resynchronization therapy (CRT) defibrillator (CRT-D), (iii) standard medical therapy ('non-device': ND), or (iv) pacing (indicated for CRT; received pacemaker or CRT pacing). Cohorts 1-3 required a left ventricular ejection fraction ≤35%, a history of heart failure, and a need for primary prevention of sudden cardiac death based on two to five previously identified risk factors. Endpoint outcomes were adjudicated by the independent committees. ICD and CRT-D cohorts, considered as high-voltage (HV) cohorts, were pooled for Kaplan-Meier analysis and propensity-matched to Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) arm B and C patients. The study enrolled 354 patients followed for 19.6 ± 6.5 months, with a minimum of 12 months. Propensity-matched HV cohorts showed comparable VA (P = 0.61) and mortality rates (P = 0.29) for HINODE and MADIT-RIT. The ND cohort presented a high crossover rate to ICD therapy (6.1%, n = 7/115), and the CRT-D cohort showed elevated mortality rates. The pacing cohort revealed that patients implanted with pacemakers had higher mortality (26.0%) than those with CRT-Pacing (8.4%, P = 0.05). CONCLUSIONS: The mortality and VA event rates of landmark trials are applicable to patients with primary prevention in Japan. Patients who did not receive guideline-indicated CRT devices had poor outcomes.

Thromboembolic events and hemorrhagic stroke after mRNA (BNT162b2) and inactivated (CoronaVac) covid-19 vaccination: A self-controlled case series study.

Background: This study aims to evaluate the association between thromboembolic events and hemorrhagic stroke following BNT162b2 and CoronaVac vaccination. Methods: Patients with incident thromboembolic events or hemorrhagic stroke within 28 days of covid-19 vaccination or SARS-CoV-2 positive test during 23 February to 30 September 2021 were included. The incidence per 100,000 covid-19 vaccine doses administered and SARS-CoV-2 test positive cases were estimated. A modified self-controlled case series (SCCS) analysis using the data from the Hong Kong territory-wide electronic health and vaccination records. Seasonal effect was adjusted by month. Findings: A total of 5,526,547 doses of BNT162b2 and 3,146,741 doses of CoronaVac were administered. A total of 334 and 402 thromboembolic events, and 57 and 49 hemorrhagic stroke cases occurred within 28 days after BNT162b2 and CoronaVac vaccination, respectively. The crude incidence of thromboembolic events and hemorrhagic stroke per 100,000 doses administered for both covid-19 vaccines were smaller than that per 100,000 SARS-CoV-2 test positive cases. The modified SCCS detected an increased risk of hemorrhagic stroke in BNT162b2 14-27 days after first dose with adjusted IRR of 2.53 (95% CI 1.48-4.34), and 0-13 days after second dose with adjusted IRR 2.69 (95% CI 1.54-4.69). No statistically significant risk was observed for thromboembolic events for both vaccines. Interpretation: We detected a possible safety signal for hemorrhagic stroke following BNT162b2 vaccination. The incidence of thromboembolic event or hemorrhagic stroke following vaccination is lower than that among SARS-CoV-2 test positive cases; therefore, vaccination against covid-19 remains an important public health intervention. Funding: This study was funded by a research grant from the Food and Health Bureau, The Government of the Hong Kong Special Administrative Region (reference COVID19F01).

Impact of reduction in early- and late-systolic functional mitral regurgitation on reverse remodelling after cardiac resynchronization therapy.

AIMS: To examine whether the presence of pre-pacing functional mitral regurgitation (MR) and its improvement would affect the extent of left ventricular (LV) reverse remodelling after cardiac resynchronization therapy (CRT). METHODS AND RESULTS: Echocardiographic assessment was performed in 83 patients before and 3 months after CRT. Total MR volume and the early- and late-systolic MR flow rate were assessed. At 3 months, there was reduction in total MR volume (38 ± 20 vs. 33 ± 21 mL) with decrease in both early- (71 ± 52 vs. 60 ± 51 mL/s) and late-systolic (49 ± 46 vs. 42 ± 46 mL/s) MR flow rate (all P < 0.05). Receiver-operating characteristic curve found that an 11% decrease in total MR volume was associated with LV reverse remodelling [defined by the reduction in LV end-systolic volume (LVESV) of ≥15%] [sensitivity, 90%; specificity, 80%; area under the curve (AUC), 0.85; P < 0.001]. The improvement in early- and late-systolic MR was also associated with LV reverse remodelling, in which improvement in early-systolic MR had higher sensitivity, specificity, and AUC than late-systolic MR. The extent of reverse remodelling with gain in LV ejection fraction and forward stroke volume was greatest in patients with improvement in total MR, intermediate in those with mild or no MR at baseline, and the least in those without improvement in total MR (LVESV, -29.8 ± 12.0 vs. -18.6 ± 16.6 vs. -5.5 ± 8.6%; ejection fraction, 11.8 ± 6.2 vs. 7.0 ± 6.8 vs. 3.0 ± 5.0%; forward stroke volume, 43.1 ± 37.9 vs. 21.1 ± 26.1 vs. 6.8 ± 34.6%; all P < 0.05). CONCLUSION: Improvement of functional MR contributes to LV reverse remodelling after CRT, whereas reduction of early-systolic MR is more powerful than late-systolic MR.

Prevalence and determinants of left ventricular systolic dyssynchrony in patients with normal ejection fraction received right ventricular apical pacing: a real-time three-dimensional echocardiographic study.

AIMS: Right ventricular apical (RVA) pacing may induce mechanical dyssynchrony. However, its impact on patients with normal ejection fraction (EF) is not fully understood. This study examined the prevalence and predictors of RVA pacing-induced systolic dyssynchrony by real-time three-dimensional echocardiography (RT3DE), and evaluated its impact on left ventricular (LV) function. METHODS AND RESULTS: Ninety-three patients with sinus node dysfunction and normal EF (>50%) received RVA-based dual-chamber pacing were assessed by RT3DE during RVA pacing (V-pace) and intrinsic conduction (V-sense). Systolic dyssynchrony was evaluated using the standard deviation of the time to minimal regional volume of 16 LV segments (Tmsv-16SD), and a cutoff value of 16 ms was determined from 93 normal controls. Systolic dyssynchrony was induced in 49.5% of patients at V-pace with significant increase in LV end-systolic volume (LVESV), decrease in EF, and worsening of Tmsv-16SD (all P < 0.001). Furthermore, patients who developed dyssynchrony had larger LVESV (P < 0.001), lower EF (P < 0.001) at V-pace mode, and higher cumulative percentage of RVA pacing in the past 6 months (P < 0.001) than those without systolic dyssynchrony. In multivariate logistic regression analysis, independent predictors of developing LV systolic dyssynchrony during V-pace included a low normal EF at V-sense, pre-existing LV hypertrophy, and cumulative RVA pacing >40% in the past 6 months. CONCLUSION: For patients with preserved EF received RVA pacing, half of them would develop systolic dyssynchrony which was associated with EF deterioration and LV enlargement. A low normal EF, a high cumulative percentage of RVA pacing, and pre-existing LV hypertrophy were predictors of developing dyssynchrony.

Atrioventricular Synchronous Pacing Using a Leadless Ventricular Pacemaker: Results From the MARVEL 2 Study.

OBJECTIVES: This study reports on the performance of a leadless ventricular pacemaker with automated, enhanced accelerometer-based algorithms that provide atrioventricular (AV) synchronous pacing. BACKGROUND: Despite many advantages, leadless pacemakers are currently only capable of single-chamber ventricular pacing. METHODS: The prospective MARVEL 2 (Micra Atrial tRacking using a Ventricular accELerometer 2) study assessed the performance of an automated, enhanced accelerometer-based algorithm downloaded to the Micra leadless pacemaker for up to 5 h in patients with AV block. The primary efficacy objective was to demonstrate the superiority of the algorithm to provide AV synchronous (VDD) pacing versus VVI-50 pacing in patients with sinus rhythm and complete AV block. The primary safety objective was to demonstrate that the algorithm did not result in pauses or heart rates of >100 beats/min. RESULTS: Overall, 75 patients from 12 centers were enrolled; an accelerometer-based algorithm was downloaded to their leadless pacemakers. Among the 40 patients with sinus rhythm and complete AV block included in the primary efficacy objective analysis, the proportion of patients with ≥70% AV synchrony at rest was significantly greater with VDD pacing than with VVI pacing (95% vs. 0%; p < 0.001). The mean percentage of AV synchrony increased from 26.8% (median: 26.9%) during VVI pacing to 89.2% (median: 94.3%) during VDD pacing. There were no pauses or episodes of oversensing-induced tachycardia reported during VDD pacing in all 75 patients. CONCLUSIONS: Accelerometer-based atrial sensing with an automated, enhanced algorithm significantly improved AV synchrony in patients with sinus rhythm and AV block who were implanted with a leadless ventricular pacemaker. (Micra Atrial Tracking Using a Ventricular Accelerometer 2 [MARVEL 2]; NCT03752151).

Predictors of atrial mechanical sensing and atrioventricular synchrony with a leadless ventricular pacemaker: Results from the MARVEL 2 Study.

BACKGROUND: The MARVEL (Micra Atrial TRacking Using a Ventricular AccELerometer) 2 study assessed the efficacy of atrioventricular (AV) synchronous pacing with a Micra leadless pacemaker. Average atrioventricular synchrony (AVS) was 89.2%. Previously, low amplitude of the Micra-sensed atrial signal (A4) was observed to be a factor of low AVS. OBJECTIVE: The purpose of this study was to identify predictors of A4 amplitude and high AVS. METHODS: We analyzed 64 patients enrolled in MARVEL 2 who had visible P waves on electrocardiogram for assessing A4 amplitude and 40 patients with third-degree AV block for assessing AVS at rest. High AVS was defined as >90% correct atrial-triggered ventricular pacing. The association between clinical factors and echocardiographic parameters with A4 amplitude was investigated using a multivariable model with lasso variable selection. Variables associated with A4 amplitude together with premature ventricular contraction burden, sinus rate, and sinus rate variability (standard deviation of successive differences of P-P intervals [SDSD]) were assessed for association with AVS. RESULTS: In univariate analysis, low A4 amplitude was inversely related to atrial function assessed by E/A ratio and e'/a' ratio, and was directly related to atrial contraction excursion (ACE) and atrial strain (Ɛa) on echocardiography (all P ≤.05). The multivariable lasso regression model found coronary artery bypass graft history, E/A ratio, ACE, and Ɛa were associated with low A4 amplitude. E/A ratio and SDSD were multivariable predictors of high AVS, with >90% probability if E/A <0.94 and SDSD <5 bpm. CONCLUSION: Clinical parameters and echocardiographic markers of atrial function are associated with A4 signal amplitude. High AVS can be predicted by E/A ratio <0.94 and low sinus rate variability at rest.

Higher Incidence of Asymptomatic Cerebral Emboli After Atrial Fibrillation Ablation Found With High-Resolution Diffusion-Weighted Magnetic Resonance Imaging.

BACKGROUND: Asymptomatic cerebral emboli (ACE) are commonly seen on cerebral magnetic resonance imaging (MRI) after atrial fibrillation ablation, but the incidence in previous studies varies widely. No data exists to compare the effects of different diffusion-weighted imaging (DWI) settings on detecting ablation-related ACE. This self-control study sought to compare the incidence and characteristics of ablation-related ACE between high-resolution DWI and conventional DWI. METHODS: A total of 55 consecutive patients referred for atrial fibrillation ablation between December 2017 and September 2018 were enrolled. Patients underwent high-resolution DWI 1 day before ablation and repeated high-resolution DWI and conventional DWI within 48 hours post-ablation. The incidence, number, size, and location of ACE were compared between 2 DWI settings in the same patients. RESULTS: The high-resolution DWI revealed a higher incidence of acute ACE compared with conventional DWI (67.3% versus 41.8% of patients, P<0.001) and significantly more ACE (106 versus 45 lesions, P=0.001). For ACE seen on both scans, the size measured by high-resolution DWI was larger (5.42 versus 4.21 mm, P<0.001). No patients had any impaired neurocognitive performance during follow-up. Impaired left ventricular ejection fraction (P=0.012) and low intraoperative activated clotting time (P=0.009) level were associated with the occurrence of ACE in a multivariate analysis. CONCLUSIONS: High-resolution DWI revealed a higher incidence and greater details of post-ablation ACE in patients with atrial fibrillation. MRI settings significantly impact the detection of ACE and should be considered when comparing incidence rates of ACE among different studies. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01761188.

Difference in prevalence and pattern of mechanical dyssynchrony in left bundle branch block occurring in right ventricular apical pacing versus systolic heart failure.

BACKGROUND: This study compared the prevalence and pattern of mechanical dyssynchrony in patients with normal heart and right ventricular apical (RVA) pacing versus patients with systolic heart failure (SHF) and spontaneous left bundle branch block (LBBB). METHODS: A total of 112 patients having LBBB pattern on surface electrocardiogram were included (57 with ejection fraction>50% received RVA pacing; 55 had SHF with ejection fraction<35%). Using tissue Doppler imaging, systolic and diastolic dyssynchrony was defined by the standard deviation of the time to peak systolic and peak early diastolic velocity, respectively. RESULTS: Despite comparable QRS duration and LBBB pattern, the prevalence of electromechanical dyssynchrony was significantly lower in the patients with RVA pacing (systolic: 54% vs 73%, chi2=4.058, P=.044; diastolic: 32% vs 61%, chi2=9.738, P=.002). The presence of coexisting systolic and diastolic dyssynchrony, isolated systolic dyssynchrony, isolated diastolic dyssynchrony, and no dyssynchrony also showed a different distribution between the 2 groups (RVA pacing: 14%, 40%, 18%, and 28%; SHF: 51%, 22%, 11%, and 16%; chi2=17.498, P=.001). Furthermore, the SHF group had a higher prevalence of medial wall (ie, septal, anteroseptal, and inferior) delay (56% vs 30%), whereas RVA pacing resulted in more free wall (ie, lateral, posterior and anterior) delay (44% vs 70%) (chi2=8.050, P=.005). CONCLUSIONS: The prevalence of mechanical dyssynchrony is lower in patients with normal ejection fraction and RVA pacing when compared with patients with SHF and spontaneous LBBB. The pattern of delay in contraction also appears to be different between the 2 groups.

Preliminary results with percutaneous transcatheter microwave ablation of typical atrial flutter.

BACKGROUND: Linear microwave ablation has been shown to be effective for treatment of atrial fibrillation during open-heart surgery by producing transmural lesions in the atrium to isolate the pulmonary veins. However, the safety and efficacy of percutaneous, transcatheter, linear microwave ablation for atrial arrhythmias, while demonstrated in animal models, is unknown in humans. Therefore, we studied the safety and efficacy of linear microwave ablation of the cavotricuspid isthmus (CTI) in humans with typical atrial flutter, utilizing a 2-cm long microwave antenna mounted on a steerable 9-French catheter. METHODS AND RESULTS: In seven consecutive patients, multielectrode catheters were positioned at the His bundle (quadripolar) and around the TV annulus (duo-decapolar) for pacing and recording atrial activation sequence before and after ablation. The microwave antenna was withdrawn gradually from tricuspid annulus towards inferior vena cava to ablate the CTI. Intracardiac ultrasound was used to ensure adequate endocardial contact of the microwave ablation catheter with the CTI. Microwave energy was applied at a power of 18 to 21 W at each ablation point for 120 seconds. Ablation was repeated until bidirectional CTI block was confirmed by demonstrating a descending activation wavefront in the contralateral atrial wall during pacing from the coronary sinus ostium or low lateral right atrium, respectively. Bidirectional isthmus block was achieved in all patients, after a mean number of 27.4 +/- 14.7 energy applications per patients. There were no acute procedural complications. CONCLUSIONS: Percutaneous, transcatheter microwave ablation of CTI dependent atrial flutter was demonstrated to be safe and effective in this preliminary feasibility study.

The Pacing to Avoid Cardiac Enlargement (PACE) trial: clinical background, rationale, design, and implementation.

BACKGROUND: Deleterious effect on left ventricular (LV) function was observed with conventional right ventricular apical (RVA) pacing. Preliminary data suggested that biventricular pacing (BiV) may be superior to RVA pacing in patients with LV systolic dysfunction. However, the optimal pacing mode and site(s) for patients with normal LV systolic function remain controversial. METHODS: The Pacing to Avoid Cardiac Enlargement (PACE) trial is a prospective, multicenter, randomized, double blinded, parallel, controlled study aiming to determine if BiV pacing is better than conventional RVA pacing in preserving LV systolic function and preventing remodeling in patients with LV ejection fraction (EF) > or = 45% indicated for pacing. This study targets to recruit 200 patients from various centers in Asia, all of whom will receive BiV pacemaker implantation before being randomized to either atrial-based RVA or BiV pacing for 1 year. Their echocardiographic parameters including LV volumes, left ventricular ejection fraction (LVEF), and dyssynchrony index by tissue Doppler imaging, exercise capacity, quality of life assessment, neurohormone levels, and clinical events will be assessed before and after pacing. The primary endpoints are changes in LV end-systolic volume and LVEF 1 year after pacing. It is designed with 90% power to detect a 5% difference in the LVEF after 1 year of pacing. The enrollment began in 2006. It is expected to conclude at the end of 2008. CONCLUSION: The PACE trial will determine whether atrial-based BiV pacing can preserve LV systolic function and prevent LV adverse remodeling induced by conventional RVA pacing in patients with normal LV systolic function and standard pacing indication.

Clinical versus echocardiographic parameters to assess response to cardiac resynchronization therapy.

Currently, a clear definition of response to cardiac resynchronization therapy (CRT) is still lacking, and clinical and echocardiographic end points are used. It is also unclear whether patients with clinical responses also improve in echocardiographic end points (and vice versa). To better understand and define response to CRT, the relation between improvement in clinical and echocardiographic parameters was evaluated in 144 patients.

Effects of cardiac resynchronization therapy on incidence of atrial fibrillation in patients with poor left ventricular systolic function.

Although the beneficial role of cardiac resynchronization therapy (CRT) in selected patients with heart failure is well proven, its effect on the incidence of atrial fibrillation (AF) is unclear. The present study compared the incidence of AF in 36 consecutive patients with chronic heart failure receiving CRT with its incidence in controls matched for age, gender, and left ventricular ejection fraction but not receiving CRT. The findings suggest that patients with CRT had a significantly lower incidence of AF than controls. Further studies to establish the role of CRT in preventing AF and its mechanisms are warranted.