David F. Briceno

Impact of Contact Force Technology on Atrial Fibrillation Ablation: A Meta‐Analysis

Background Catheter–tissue contact is essential for effective lesion formation, thus there is growing usage of contact force (CF) technology in atrial fibrillation ablation. We conducted a meta-analysis to assess the impact of CF on clinical outcomes and procedural parameters in comparison to conventional catheter for atrial fibrillation ablation. Methods and Results An electronic search was performed using major databases. Outcomes of interest were recurrence rate, major complications, total procedure, and fluoroscopic times. Continuous variables were reported as standardized mean difference; odds ratios were reported for dichotomous variables. Eleven studies (2 randomized controlled studies and 9 cohorts) involving 1428 adult patients were identified. CF was deployed in 552 patients. The range of CF used was between 2 to 60 gram-force. The follow-up period ranged between 10 and 53 weeks. In comparing CF and conventional catheter groups, the recurrence rate was lower with CF (35.1% versus 45.5%, odds ratio 0.62 [95% CI 0.45–0.86], P=0.004). Shorter procedure and fluoroscopic times were achieved with CF (procedure time: 156 versus 173 minutes, standardized mean difference −0.85 [95% CI −1.48 to −0.21], P=0.009; fluoroscopic time: 28 versus 36 minutes, standardized mean difference −0.94 [95% CI −1.66; −0.21], P=0.01). Major complication rate was lower numerically in the CF group but not statistically significant (1.3% versus 1.9%, odds ratio 0.71 [95% CI 0.29–1.73], P=0.45). Conclusions The use of CF technology results in significant reduction of the atrial fibrillation recurrence rate after atrial fibrillation ablation in comparison to the conventional catheter group. CF technology is able to significantly reduce procedure and fluoroscopic times without compromising complication rate.

Left atrial appendage morphology assessment for risk stratification of embolic stroke in patients with atrial fibrillation: A meta-analysis

BACKGROUND Thromboembolic event (TE) risk stratification is performed by using CHA2DS2VASc score. It has been suggested that left atrial appendage (LAA) morphology independently influences TE risk in patients with nonvalvular atrial fibrillation. LAA morphology has been classified into 4 types: chicken wing, cauliflower, windsock, and cactus. OBJECTIVE The purpose of this study was to determine TE risk for each LAA morphology in patients with atrial fibrillation with low to intermediate TE risk. METHODS A systematic review of MEDLINE, Cochrane Library, and Embase for studies that used computed tomography, tridimensional transesophageal echocardiography, and cardiac magnetic resonance imaging to categorize the LAA morphologies with assessment of TE prevalence. Odds ratio (OR) and 95% confidence intervals (CIs) were measured using the Mantel-Haenszel method. The fixed effects model was used, and if heterogeneity (I2) was >25%, effects were analyzed using a random model. RESULTS Eight studies with 2596 patients were included. Eighty-four percent (n=1872) of patients had a CHADS2 score of <2. TE risk was lower in chicken wing morphology than in non-chicken wing morphology (OR 0.46; 95% CI 0.36-0.58). Likewise, chicken wing morphology had lower TE risk than did other morphologies (chicken wing vs cauliflower: OR 0.38; 95% CI 0.26-0.56; chicken wing vs windsock: OR 0.48; 95% CI 0.31-0.73; chicken wing vs cactus: OR 0.49; 95% CI 0.36-0.66). CONCLUSION Patients with chicken wing LAA morphology are less likely to develop TE than patients with non-chicken wing morphology. LAA morphology may be a valuable criterion in predicting TE and could affect the stratification and anticoagulation management of patients with low to intermediate TE risk.

A meta-analysis and meta-regression of long-term outcomes of transcatheter versus surgical aortic valve replacement for severe aortic stenosis

BACKGROUND Transcatheter aortic valve replacement (TAVR) has emerged as an alternative to surgical aortic-valve replacement (SAVR) for patients with severe symptomatic aortic stenosis (AS) who are at high operative risk. We sought to determine the long-term (≥1year follow-up) safety and efficacy TAVR compared with SAVR in patients with severe AS. METHODS A comprehensive search of PubMed, EMBASE, Cochrane Central Register of Controlled Trials, conference proceedings, and relevant Web sites from inception through 10 April 2016. RESULTS Fifty studies enrolling 44,247 patients met the inclusion criteria. The mean duration follow-up was 21.4months. No difference was found in long-term all-cause mortality (risk ratios (RR), 1.06; 95% confidence interval (CI) 0.91-1.22). There was a significant difference favoring TAVR in the incidence of stroke (RR, 0.82; 95% CI 0.71-0.94), atrial fibrillation (RR, 0.43; 95% CI 0.33-0.54), acute kidney injury (RR, 0.70; 95% CI 0.53-0.92), and major bleeding (RR, 0.57; 95% CI 0.40-0.81). TAVR had significant higher incidence of vascular complications (RR, 2.90; 95% CI 1.87-4.49), aortic regurgitation (RR, 7.00; 95% CI 5.27-9.30), and pacemaker implantation (PPM) (RR, 2.02; 95% CI 1.51-2.68). TAVR demonstrated significantly lower stroke risk compared to SAVR in high-risk patients (RR, 1.49; 95% CI 1.06-2.10); no differences in PPM implantation were observed in intermediate-risk patients (RR, 1.68; 95% CI 0.94-3.00). In a meta-regression analysis, the effect of TAVR baseline clinical features did not affect the long-term all-cause mortality outcome. CONCLUSION TAVR and SAVR showed similar long-term survival in patients with severe AS; with important differences in treatment-associated morbidity.

Comparison of local versus general anesthesia in patients undergoing transcatheter aortic valve replacement: A meta-analysis

Transcatheter aortic valve replacement (TAVR) is typically performed under general anesthesia (GA). However, there is increasing data supporting the safety of performing TAVR under local anesthesia/conscious sedation (LA). We performed a meta‐analysis to gain better understanding of the safety and efficacy of LA versus GA in patients with severe aortic stenosis undergoing TAVR.

Therapeutic hypothermia in ST elevation myocardial infarction: a systematic review and meta-analysis of randomised control trials

Objective Our objective is to gain a better understanding of the efficacy and safety of therapeutic hypothermia (TH) in patients with acute ST elevation myocardial infarction (STEMI) through an analysis of randomised controlled trials (RCTs). Background Several RCTs have suggested a positive outcome with the use of TH in the prevention of myocardial injury in the setting of an acute STEMI. However, there are currently no clinical trials that have conclusively shown any significant benefit. Methods Electronic databases were used to identify RCTs of TH in the patient population with STEMI. The primary efficacy end point was major adverse cardiovascular event (MACE). Secondary efficacy end points included all-cause mortality, infarct size, new myocardial infarction and heart failure/pulmonary oedema (HF/PO). All-bleeding, ventricular arrhythmias and bradycardias were recorded as the safety end points. Results Six RCTs were included in this meta-analysis, enrolling a total of 819 patients. There was no significant benefit from TH in preventing MACE (OR, 01.04; 95% CI 0.37 to 2.89), all-cause mortality (OR, 1.48; 95% CI 0.68 to 3.19), new myocardial infarction (OR, 0.99; 95% CI 0.20 to 4.94), HF/PO (OR, 0.52; 95% CI 0.15 to 1.77) or infarct size (standard difference of the mean (SDM), −0.1; 95% CI −0.23 to 0.04). However, a significant reduction of infarct size was observed with TH utilisation in anterior wall myocardial infarction (SDM, −0.23; 95% CI −0.45 to −0.02). There was no significant difference seen for the safety end points all-bleeding (OR 1.32; 95% CI 0.77 to 2.24), ventricular arrhythmias (OR, 0.85; 95% CI 0.54 to 1.36) or bradycardias (OR, 1.16; 95% CI 0.74 to 1.83). Conclusions Although TH appears to be safe in patients with STEMI, meta-analysis of published RCTs indicates that benefit is limited to reduction of infarct size in patients with anterior wall involvement with no demonstrable effect on all-cause mortality, recurrent myocardial infarction or HF/PO.

Culprit-lesion only versus complete multivessel percutaneous intervention in ST-elevation myocardial infarction: A systematic review and meta-analysis of randomized trials.

BACKGROUND ST-segment elevation myocardial infarction (STEMI) in patients with concomitant multivessel (MV) coronary artery disease (CAD) is associated with poor outcomes. Percutaneous coronary intervention (PCI) of the culprit-lesion only (CLO) as compared with a MV PCI approach to revascularization remains uncertain. Our objective is to gain a better understanding of the efficacy and safety of CLO as compared with MV PCI in patients with STEMI by conducting an updated meta-analysis. METHODS A comprehensive search of PubMed, CENTRAL, EMBASE, The Cochrane Central Register, the ClinicalTrials.gov Website, and Google Scholar databases of randomized controlled trials (RCTs) was performed. RESULTS Seven RCTs were included, enrolling a total of 2006 patients. We found that there was a significant reduction in major adverse cardiovascular events (MACE) (OR, 0.62; 95% CI, 0.43-0.90), cardiovascular mortality (OR, 0.46; 95% CI, 0.27-0.80), and repeat revascularization (RRV) (OR, 0.39; 95% CI, 0.30-0.51) favoring MV over the CLO approach for patients undergoing primary PCI. The number needed to treat in order to prevent one CV mortality, RRV, or MACE event is 47, 11, and 16 patients, respectively. No differences were observed between MV vs. CLO PCI for subsequent myocardial infarction (OR, 0.74; 95% CI, 0.40-1.39), all-cause mortality (OR, 0.78; 95% CI, 0.53-1.15), non-cardiovascular mortality (OR, 1.35; 95% CI, 0.74-2.48), all-bleeding events (OR, 0.82; 95% CI, 0.40-1.65), contrast-induced nephropathy (OR, 0.72; 95% CI, 0.33-1.54), and stroke (OR, 1.28; 95% CI, 0.47-3.46). CONCLUSIONS MV PCI significantly reduces the rate of MACE, CV mortality, and RRV without significant harm as compared to CLO PCI.

Left Atrial Appendage Occlusion Device and Novel Oral Anticoagulants Versus Warfarin for Stroke Prevention in Nonvalvular Atrial Fibrillation Systematic Review and Meta-Analysis of Randomized Controlled Trials

Background—Nonvalvular atrial fibrillation is the most common arrhythmia. Patients with nonvalvular atrial fibrillation are at increased risk of stroke; therefore, we evaluated the efficacy and safety of different approaches to prevent this major complication. Methods and Results—We conducted electronic database searches of phase III randomized controlled trials. The groups were novel oral anticoagulants, Watchman left atrial appendage occlusion device (DEVICE), and warfarin. Efficacy outcomes were stroke or systemic embolism, and all-cause mortality. Safety outcome was major bleeding and procedure-related complications. A subgroup analysis of the elderly population was done. We used random-effects model to compare pooled outcomes and tested for heterogeneity. Odds ratios (ORs) and 95% confidence intervals (CIs) were computed for each outcome. Seven randomized controlled trials (n=73 978) were included. There was a significant difference favoring novel oral anticoagulants for systemic embolism (OR, 0.84; 95% CI, 0.72–0.97; P=0.01), all-cause mortality (OR, 0.89; 95% CI, 0.84–0.94; P<0.001), and safety outcomes (OR, 0.79; 95% CI, 0.65–0.97; P=0.026) compared with warfarin. No difference was seen between DEVICE and warfarin for efficacy end points; however, DEVICE had more complications (OR, 1.85; 95% CI, 1.14–3.01; P=0.012). In the elderly (6 randomized controlled trials, n=30 699), systemic embolism was favored with novel oral anticoagulants over warfarin (OR, 0.77; 95% CI, 0.68–0.87; P⩽0.001). No evidence of significant publication bias was found. Conclusions—Novel oral anticoagulants is superior to warfarin for stroke prevention in nonvalvular atrial fibrillation. This benefit was also observed in the elderly population. DEVICE is a reasonable noninferior alternative to warfarin for stroke prevention, but cautious use is essential given safety concerns.

Long-term outcomes of different ablation strategies for ventricular tachycardia in patients with structural heart disease: Systematic review and meta-analysis

Aims To compare the long-term outcomes of standard ablation of stable ventricular tachycardia (VT) vs. substrate modification, and of complete vs. incomplete substrate modification in patients with structural heart disease (SHD) presenting with VT. Methods and results An electronic search was performed using major databases. The main outcomes were a composite of long-term ventricular arrhythmia (VA) recurrence and all-cause mortality of standard ablation of stable VT vs. substrate modification, and long-term VA recurrence in complete vs. incomplete substrate modification. Six studies were included for the comparison of standard ablation of stable VT vs. substrate modification, with a total of 396 patients (mean age 63 ± 10 years, 87% males), and seven studies were included to assess the impact of extensive substrate modification, with a total of 391 patients (mean age 64 ± years, 90% males). More than 70% of all the patients included had ischaemic cardiomyopathy. Substrate modification was associated with decreased composite VA recurrence/all-cause mortality compared to standard ablation of stable VTs [risk ratio (RR) 0.57, 95% confidence interval (CI) 0.40-0.81]. Complete substrate modification was associated with decreased VA recurrence as compared to incomplete substrate modification (RR 0.39, 95% CI 0.27-0.58). Conclusion In patients with SHD who had VT related mainly to ischaemic substrates, there was a significantly lower risk of the composite primary outcome of long-term VA recurrence and all-cause mortality among those undergoing substrate modification compared to standard ablation. Long-term success is improved when performing complete substrate modification.

Substrate Ablation of Ventricular Tachycardia: Late Potentials, Scar Dechanneling, Local Abnormal Ventricular Activities, Core Isolation, and Homogenization

Ventricular arrhythmias are a frequent cause of mortality in patients with ischemic cardiomyopathy and nonischemic cardiomyopathy. Scar-related reentry represents the most common arrhythmia substrate in patients with recurrent episodes of sustained ventricular tachycardia (VT). Initial mapping of scar-related VT circuits is focused on identifying arrhythmogenic tissue. The substrate-based strategies include targeting late potentials, scar dechanneling, local abnormal ventricular activities, core isolation, and homogenization of the scar. Even though substrate-based strategies for VT ablation have shown promising outcomes for patients with structural heart disease related to ischemic cardiomyopathy, the data are scarce for patients with nonischemic substrates.

Outcomes of ≤6-month versus 12-month dual antiplatelet therapy after drug-eluting stent implantation: A meta-analysis and meta-regression.

Background:The benefit of ⩽6-month compared with 12-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) placement remains controversial. We performed a meta-analysis and meta-regression of ⩽6-month versus 12-month DAPT in patients undergoing PCI with DES placement. Methods:We conducted electronic database searches of randomized controlled trials (RCTs) comparing DAPT durations after DES placement. For studies with longer follow-up, outcomes at 12 months were identified. Odds ratios and 95% confidence intervals were computed with the Mantel–Haenszel method. Fixed-effect models were used; if heterogeneity (I2) > 40 was identified, effects were obtained with random models. Results:Nine RCTs were included with total n = 19,224 patients. No significant differences were observed between ⩽6-month compared with 12-month DAPT in all-cause mortality (OR 0.87; 95% confidence interval (CI): 0.69–1.11), cardiovascular (CV) mortality (OR 0.89; 95% CI: 0.66–1.21), non-CV mortality (OR 0.85; 95% 0.58–1.24), myocardial infarction (OR 1.10; 95% CI: 0.89–1.37), stroke (OR 0.97; 95% CI: 0.67–1.42), stent thrombosis (ST) (OR 1.37; 95% CI: 0.89–2.10), and target vessel revascularization (OR 0.95; 95% CI: 0.77–1.18). No significant difference in major bleeding (OR 0.72; 95% CI: 0.49–1.05) was observed, though the all-bleeding event rate was significantly lower in the ⩽6-month DAPT group (OR 0.76; 95% CI: 0.59–0.96). In the meta-regression analysis, a significant association between bleeding events and non-CV mortality with 12-month DAPT was found, as well as between ST and mortality in addition to MI with ⩽6-month DAPT. Conclusion:DAPT for ⩽6 months is associated with similar mortality and ischemic outcomes but less bleeding events compared with 12-month DAPT after PCI with DES.