Same-day discharge following catheter ablation and venous closure with VASCADE MVP: A postmarket registry.

INTRODUCTION: Early and safe ambulation can facilitate same-day discharge (SDD) following catheter ablation, which can reduce resource utilization and healthcare costs and improve patient satisfaction. This study evaluated procedure success and safety of the VASCADE MVP venous vascular closure system in patients with atrial fibrillation (AF). METHODS: The AMBULATE SDD Registry is a two-stage series of postmarket studies in patients with paroxysmal or persistent AF undergoing catheter ablation followed by femoral venous access-site closure with VASCADE MVP. Efficacy endpoints included SDD success, defined as the proportion of patients discharged the same day who did not require next-day hospital intervention for procedure/access site-related complications, and access site sustained success within 15 days of the procedure. RESULTS: Overall, 354 patients were included in the pooled study population, 151 (42.7%) treated for paroxysmal AF and 203 (57.3%) for persistent AF. SDD was achieved in 323 patients (91.2%) and, of these, 320 (99.1%) did not require subsequent hospital intervention based on all study performance outcomes. Nearly all patients (350 of 354; 98.9%) achieved total study success, with no subsequent hospital intervention required. No major access-site complications were recorded. Patients who had SDD were more likely to report procedure satisfaction than patients who stayed overnight. CONCLUSION: In this study, 99.7% of patients achieving SDD required no additional hospital intervention for access site-related complications during follow-up. SDD appears feasible and safe for eligible patients after catheter ablation for paroxysmal or persistent AF in which the VASCADE MVP is used for venous access-site closure.

Acute Hemodynamic Effects of Biventricular Pacing After Left Ventricular Assist Device.

BACKGROUND: Despite cardiac resynchronization therapy (CRT), some patients with heart failure progress and undergo left ventricular assist device (LVAD) implantation. Management of CRT after LVAD implantation has not been well studied. The purpose of this study was to determine whether RV pacing or biventricular pacing measurably affects acute hemodynamics in patients with an LVAD and a CRT device. METHODS AND RESULTS: Seven patients with CRT and LVAD underwent right heart catheterization. Pressures and oximetry were measured and LVAD parameters were recorded during 3 different conditions: RV pacing alone, biventricular pacing, and intrinsic atrioventricular conduction. Paired t tests were used to evaluate changes within subjects. There were no significant changes in right atrial pressure, pulmonary arterial pressures, pulmonary capillary wedge pressure, cardiac index, or any LVAD parameter (P > .05). CONCLUSIONS: Our data suggest that CRT probably has no acute hemodynamic effect in patients with LVADs, but further study is needed.

Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: Results of the U.S. Feasibility Study.

INTRODUCTION: Visually guided laser balloon (VGLB) ablation is unique in that the operator delivers ablative energy under direct visual guidance. In this multicenter study, we sought to determine the feasibility, efficacy, and safety of performing pulmonary vein isolation (PVI) using this VGLB. METHODS: Patients with symptomatic, drug-refractory paroxysmal atrial fibrillation (AF) underwent PVI using the VGLB with the majority of operators conducting their first-ever clinical VGLB cases. The primary effectiveness endpoint was defined as freedom from treatment failure that included: Occurrence of symptomatic AF episodes ≥1 minutes beyond the 90-day blanking, the inability to isolate 1 superior and 2 total PVs, occurrence of left atrial flutter or atrial tachycardia, or left atrial ablation/surgery during follow-up. RESULTS: A total of 86 patients (mean age 56 ± 10 years, 67% male) were treated with the VGLB at 10 US centers. Mean fluoroscopy, ablation, and procedure times were 39.8 ± 24.3 minutes, 205.2 ± 61.7 minutes, and 253.5 ± 71.3 minutes, respectively. Acute PVI was achieved in 314/323 (97.2%) of targeted PVs. Of 84 patients completing follow-up, the primary effectiveness endpoint was achieved in 50 (60%) patients. Freedom from symptomatic or asymptomatic AF was 61%. The primary adverse event rate was 16.3% (8.1% pericarditis, phrenic nerve injury 5.8%, and cardiac tamponade 3.5%). There were no cerebrovascular events, atrioesophageal fistulas, or significant PV stenosis. CONCLUSIONS: This multicenter study of operators in the early stage of the learning curve demonstrates that PVI can be achieved with the VGLB with a reasonable safety profile and an efficacy similar to radiofrequency ablation.

A novel electrocardiographic criterion for differentiating a left from right ventricular outflow tract tachycardia origin: the V2S/V3R index.

INTRODUCTION: Although several ECG criteria have been proposed for differentiating between left and right origins of idiopathic ventricular arrhythmias (VA) originating from the outflow tract (OT-VA), their accuracy and usefulness remain limited. This study was undertaken to develop a more accurate and useful ECG criterion for differentiating between left and right OT-VA origins. METHODS AND RESULTS: We studied OT-VAs with a left bundle branch block pattern and inferior axis QRS morphology in 207 patients who underwent successful catheter ablation in the right (RVOT; n = 154) or left ventricular outflow tract (LVOT; n = 53). The surface ECGs during the OT-VAs and during sinus beats were analyzed with an electronic caliper. The V2S/V3R index was defined as the S-wave amplitude in lead V2 divided by the R-wave amplitude in lead V3 during the OT-VA. The V2S/V3R index was significantly smaller for LVOT origins than RVOT origins (P < 0.001). The area under the curve (AUC) for the V2S/V3R index by a receiver operating characteristic analysis was 0.964, with a cut-off value of ≤1.5 predicting an LVOT origin with an 89% sensitivity and 94% specificity. In the AUC and accuracy, the V2S/V3R index was superior to any previously proposed ECG criteria in an analysis of all OT-VAs. This advantage of the V2S/V3R index over the V2 transition ratio and other indices also held true for a subanalysis of 77 OT-VAs with a lead V3 precordial transition. CONCLUSION: The V2S/V3R index outperformed other ECG criteria to differentiate left from right OT-VA origins independent of the site of the precordial transition.

Dabigatran versus warfarin therapy for uninterrupted oral anticoagulation during atrial fibrillation ablation.

BACKGROUND: Uninterrupted oral anticoagulant (OA) therapy with warfarin has become the standard of care at many centers performing catheter ablation of atrial fibrillation (AF). Compared with warfarin, dabigatran, a direct thrombin inhibitor, has been demonstrated to reduce the risk of stroke in nonvalvular AF with similar bleeding risk. Few data exist on the safety profile of uninterrupted dabigatran therapy during AF ablation. METHODS: We compared the safety and efficacy of uninterrupted OA therapy with either warfarin or dabigatran in all patients undergoing AF catheter ablation at the University of Alabama at Birmingham between November 1, 2010 and January 31, 2012. All patients underwent a transesophageal echocardiogram (TEE) on the day of their ablation procedure to assess for the presence of intracardiac thrombi. All complications were identified and classified as bleeding, thromboembolic events, or other. RESULTS: There were 212 patients in the dabigatran group and 251 patients in the warfarin group. The groups were well matched. There were 3 complications in the dabigatran group and 6 in the warfarin group (P = 0.45). There were 2 bleeding complications in the dabigatran group and 6 in the warfarin group (P = 0.23). There was one thromboembolic complication (a possible TIA) in the dabigatran group and none in the warfarin group (P = 0.28). CONCLUSION: The administration of dabigatran is as safe and effective as warfarin for uninterrupted OA therapy during catheter ablation of AF.

Cardiovascular implantable electronic device implantation with uninterrupted dabigatran: comparison to uninterrupted warfarin.

BACKGROUND: While continuation of oral anticoagulation (OAC) with warfarin may be preferable to interruption and bridging with heparin for patients undergoing cardiovascular implantable electronic device (CIED) implantation, it is uncertain whether the same strategy can be safely used with dabigatran. OBJECTIVE AND METHODS: To determine the risk of bleeding and thromboembolic complications associated with uninterrupted OAC during CIED implantation, replacement, or revision, the outcomes of patients receiving uninterrupted dabigatran (D) were compared to those receiving warfarin (W). RESULTS: D was administered the day of CIED implant in 48 patients (age 66 ± 12.4 years, 13 F and 35 M, 21 ICDs and 27 PMs), including new implant in 25 patients, replacement in 14 patients, and replacement plus lead revision in 9 patients. D was held the morning of the procedure in 14 patients (age 70 ± 11 years, 4 F and 10 M, 5 ICDs and 9 PMs). W was continued in 195 patients (age 60 ± 14.4 years, 54 F, and 141 M), including new implant in 122 patients, replacement in 33 patients, and replacement plus lead revision or upgrade in 40 patients. Bleeding complications occurred in 1 of 48 patients (2.1%) with uninterrupted dabigatran (a late pericardial effusion), 0 of 14 with interrupted D, and 9 of 195 patients (4.6%) on W (9 pocket hematomas), P = 0.69. Fifty percent of bleeding complications were associated with concomitant antiplatelet medications. CONCLUSIONS: The incidence of bleeding complications is similar during CIED implantation with uninterrupted D or W. The risks are higher when OAC is combined with antiplatelet drugs.

Idiopathic mitral annular PVCs with multiple breakouts and preferential conduction unmasked by radiofrequency catheter ablation.

A 39-year-old man with idiopathic monomorphic premature ventricular contractions (PVCs), exhibiting a right bundle branch block and inferior axis QRS morphology, underwent electrophysiological testing. After a radiofrequency (RF) application to the anterior mitral annulus (MA) eliminated the spontaneous PVC morphology, a second PVC morphology occurred. Pacing from the first ablation site exhibited an excellent match to the second PVCs with a long stimulus to QRS interval. An RF application delivered near the first lesion eliminated all PVCs. The MA PVCs in this case exhibited a single origin with multiple breakouts and preferential conduction that were unmasked by RF ablation.

Epicardial macroreentrant ventricular tachycardia associated with a left ventricular aneurysm.

A 62-year-old man with severe coronary artery disease and a left ventricular aneurysm underwent catheter ablation of ventricular tachycardia (VT) with right bundle branch block QRS morphology. Endocardial bipolar voltage mapping with standard threshold settings demonstrated no low-voltage areas within the aneurysm. Catheter ablation of the epicardial surface of the aneurysm eliminated the VT. Endocardial bipolar voltage mapping with any other settings could not predict the site of the epicardial arrhythmogenic substrate whereas endocardial unipolar voltage mapping could. Endocardial unipolar voltage mapping may be helpful for predicting epicardial arrhythmogenic substrates.

Successful reduction of a high defibrillation threshold by a combined implantation of a subcutaneous array and azygos vein lead.

A 72-year-old man with nonischemic cardiomyopathy was referred because his implantable cardioverter defibrillator had failed to terminate spontaneous ventricular fibrillation (VF). Defibrillation threshold (DFT) testing confirmed that 830-V shocks failed to defibrillate VF despite optimization of the biphasic waveform and reversal of shock polarity. The placement of a new right ventricular lead and the addition of a subcutaneous array failed to defibrillate VF at 830 V. The combination of a subcutaneous array and azygos vein coil successfully defibrillated VF. The mechanism for successful DFT reduction was likely greater current supplied to the posterior basal left ventricle by the azygos vein lead.

Successful epicardial catheter ablation of a septal ventricular tachycardia after myocardial infarction.

A 55-year-old man underwent catheter ablation of ventricular tachycardia (VT) after anterior myocardial infarction. Although electrophysiological study suggested that the VT originated from the septum, biventricular endocardial irrigated radiofrequency ablation failed to interrupt the VT. Epicardial ablation at the site located halfway between the lesions in the right and left ventricles via a pericardial approach eliminated the VT, suggesting that the VT likely originated from the top of the septum. When VTs originating from the upper septum are refractory to endocardial ablation, epicardial mapping and ablation may be considered because only that site may be accessible with an epicardial approach.

Idiopathic premature ventricular contractions successfully ablated from the epicardial right ventricular outflow tract.

A case of idiopathic premature ventricular contractions successfully ablated from the epicardial right ventricular outflow tract (RVOT) via the subxiphoid pericardial approach was described. The sites with earliest endocardial and epicardial ventricular activation were located adjacent to each other in the RVOT and at both sites, double potentials were recorded. Coronary angiography was helpful for identifying the ablation site.

Demonstration of a right ventricular substrate of ventricular tachycardia after myocardial infarction.

A 57-year-old man with prior anteroseptal myocardial infarction underwent catheter ablation of ventricular tachycardia (VT) exhibiting a left bundle branch block QRS morphology. After failed left ventricular ablation, catheter ablation from the right ventricle (RV) eliminated the VT. An RV voltage map demonstrated an area of low voltage around the successful ablation site that likely allowed for a VT substrate.

Evidence for an intramural origin of idiopathic premature ventricular contractions successfully ablated within the great cardiac vein.

A 37-year-old woman with idiopathic premature ventricular contractions (PVCs), exhibiting a right bundle branch block and inferior axis QRS morphology, underwent electrophysiological testing. The earliest ventricular activation with an isolated prepotential was observed within the great cardiac vein during the PVCs. Pacing from this site with an output of 10 mA produced an excellent pace map, whereas that with an output of 2 mA produced a wider QRS with notches in the early phase. A radiofrequency application delivered at this site eliminated the PVCs. These findings suggested that the PVC origin might have been intramural rather than epicardial.

A Novel Temperature-Controlled Radiofrequency Catheter Ablation System Used to Treat Patients With Paroxysmal Atrial Fibrillation.

OBJECTIVES: DIAMOND-AF (DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation) was a prospective, multicenter, noninferiority, randomized trial that compared the safety and effectiveness of the DTA system versus those of a force-sensing RF ablation system (control) for the treatment of patients with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (AF). BACKGROUND: Irrigated radiofrequency (RF) ablation catheters lose tissue temperature acuity, which is vital in assessing lesion formation. DiamondTemp Ablation (DTA) was designed to re-establish accurate tissue temperature measurements during ablation. METHODS: A total of 482 patients with paroxysmal AF were randomized (239 DTA, 243 control) to undergo pulmonary vein isolation and were followed up at 23 sites. Patients were screened for disease progression, cardiac characteristics, and prior interventions. Primary endpoints were effectiveness (freedom from atrial arrhythmia recurrence) and safety (composite of procedure- and device-related serious adverse events). RESULTS: The primary safety event rate was 3.3% in the DTA group versus 6.6% in the control group (p < 0.001 vs. 6.5% noninferiority margin). Primary effectiveness was met in 79.1% of DTA subjects and 75.7% of control subjects (p < 0.001 vs. -12.5% noninferiority margin). Secondary endpoint analysis found that off-drug effectiveness favored DTA compared with the control (142 [59.4%] vs. 120 [49.4%], respectively; p = 0.03). Total RF time and individual RF ablation duration were significantly shorter with less saline infused through the DTA catheter (p < 0.001). Both arms saw clinically meaningful improvements in quality of life at 12 months. CONCLUSIONS: Safety and efficacy of the DTA system proved noninferior to force-sensing RF ablation in a paroxysmal AF population. Efficiencies were observed using DTA with shorter total RF times, individual RF ablation durations, and less saline infusion. (DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation; NCT03334630).

Limited response to cardiac resynchronization therapy in patients with concomitant right ventricular dysfunction.

INTRODUCTION: Patients with left ventricular dysfunction (LVD) and LV dyssynchrony may respond to cardiac resynchronization therapy (CRT). However, right ventricular dysfunction (RVD) is a predictor of decreased survival in patients with LVD, and its influence on clinical response to CRT is unknown. The purpose of this study was to examine the effect of RVD on the clinical response to CRT. METHODS AND RESULTS: A retrospective cohort of consecutive patients who underwent implantation of a CRT implantable cardioverter-defibrillator (ICD) were included and deemed to have RVD based on a RV ejection fraction <0.40. A lack of response to CRT was defined as: death, heart transplantation, implantation of an LV assist device, absent improvement in NYHA functional class at 6 months or hospice care. Among 130 patients included (mean age 58 +/- 11 years, 68.5% male, 87.7% Caucasian, 51.5% nonischemic cardiomyopathy), 77 (59.2%) had no response to CRT as defined above. Of the nonresponders, 43 (56%) had RVD and 34 (44%) did not have RVD (P = 0.02). After adjustment for age, race, gender, cardiomyopathy type, atrial fibrillation, serum sodium, and severe mitral regurgitation, RVD (adjusted OR = 0.34, 95%CI 0.14-0.82), female gender (adjusted OR = 0.36, 95%CI 0.14-0.95), and serum creatinine (adjusted OR = 0.25, 95%CI 0.09-0.71) were independently associated with decreased odds of response to CRT. There was a significant difference in survival of patients with and without RVD after CRT (log rank P = 0.01). CONCLUSION: RVD represents a strong predictor of lack of clinical response to CRT in patients with CHF due to LVD and should be considered when prescribing CRT.

Idiopathic left ventricular arrhythmias originating adjacent to the left aortic sinus of valsalva: electrophysiological rationale for the surface electrocardiogram.

BACKGROUND: Idiopathic ventricular arrhythmias (VAs) may be amenable to catheter ablation within or adjacent to the left sinus of Valsalva (LSOV). However, features that discriminate these sites have not been defined. The purpose of this study was to determine the electrocardiographic and electrophysiological features of VAs originating within or adjacent to the LSOV. METHODS AND RESULTS: We studied 48 consecutive patients undergoing successful catheter ablation of idiopathic VAs originating from the left coronary cusp (LCC, n = 29), aortomitral continuity (AMC, n = 10) and great cardiac vein or anterior interventricular cardiac vein (Epi, n = 9). A small r wave, or rarely an R wave, was typically observed in lead I during the VAs and pacing in these regions. An S wave in lead V5 or V6 occurred significantly more often during both the VAs and pacing from the AMC than during that from the LCC and Epi (p < 0.05 to 0.0001). For discriminating whether VA origins can be ablated endocardially or epicardially, the maximum deflection index (MDI = the shortest time to the maximum deflection in any precordial lead/QRS duration) was reliable for VAs arising from the AMC (100%), but was less reliable for LCC (73%) and Epi (67%) VAs. In 3 (33%) of the Epi VAs, the site of an excellent pace map was located transmurally opposite to the successful ablation site (LCC = 1 and AMC = 2). CONCLUSIONS: The MDI has limited value for discriminating endocardial from epicardial VA origins in sites adjacent to the LSOV probably due to preferential conduction, intramural VA origins or myocardium in contact with the LCC.

Successful catheter ablation of epicardial ventricular tachycardia worsened by cardiac resynchronization therapy.

Soon after an upgrade from a single-chamber implantable cardioverter-defibrillator (ICD) to cardiac resynchronization therapy (CRT) with an ICD, a 64-year-old man with non-ischaemic cardiomyopathy began to have increasingly frequent ICD shocks for slow ventricular tachycardia (VT). At electrophysiological study, no clinical VT was induced by endocardial right ventricular pacing, but was easily induced by epicardial left ventricular (LV) pacing via a subxiphoid pericardial approach. The VT was successfully ablated on the LV epicardial surface. This case suggests that epicardial catheter ablation may be an alternative for managing CRT-induced proarrhythmias without the inactivation of LV pacing.

A couplet of PVCs with different QRS morphologies arising from a single origin in the left ventricular outflow tract.

A 59-year-old man with two different premature ventricular contractions (PVCs) forming a couplet underwent electrophysiological testing. Although pacing from the aorto-mitral continuity (AMC) produced an excellent pace map of one type of PVCs, a radiofrequency application within the right coronary cusp (RCC) eliminated all the PVCs. This case demonstrates that a single origin with two breakout sites in the left ventricular ostium (LVos) may result in a couplet consisting of different PVCs and preferential conduction from the RCC to AMC may also occur. These possibilities should be kept in our mind when predicting sites of origin of LVos ventricular arrhythmias.

Idiopathic ventricular tachycardia originating from the left ventricle near the His bundle.

A 62-year-old man with idiopathic ventricular tachycardia (VT) exhibiting left bundle branch block and left inferior axis QRS morphology with a Qr in lead III underwent electrophysiological testing. Successful ablation was achieved in the left ventricle (LV) at a site with an excellent pace map, adjacent to the His bundle electrogram recording site. At that site, the sequence of the ventricular electrogram and late potential recorded during sinus rhythm reversed during spontaneous premature ventricular contractions with the same QRS morphology as the VT. This case shows that VT can arise from the LV ostium adjacent to the membranous septum.