Laura Perrotta

Impact of cardiac resynchronization therapy on the severity of mitral regurgitation

AIMS Functional mitral regurgitation (MR) could be managed by both cardiac resynchronization therapy (CRT) and mitral-valve surgery. Clinical decision making regarding the appropriateness of mitral-valve surgery vs. CRT is a challenging task. This study assessed the prevalence and prognosis of various degrees of functional MR in CRT candidates. Additionally, we sought to identify functional MR patients who either can be adequately managed by CRT only or will need surgery. METHODS AND RESULTS Cardiac resynchronization therapy recipients (n= 794) were followed-up for 26 ± 18 months. Mitral regurgitation severity was quantified on scale 0-4. Cardiac resynchronization therapy responders were identified based on improvement in the New York Heart Association class and left-ventricular ejection fraction. Severity of MR and LV reverse remodelling were assessed at 3 and 12 months. Predictors of long-term MR change and CRT response were explored with multivariable models. Mitral regurgitation was present in 86%, with 35% prevalence of advanced MR (grade 3-4). Improvement of MR ≥ 1° after 12 months occurred in 46% of patients. It was relatively more frequent in patients with advanced MR at baseline (63%, P< 0.01). Baseline MR severity and change in MR at 3-month follow-up predicted response to CRT. Patients with ≥ 1° MR improvement at 12 months had more reverse remodelling compared with those with no change or worsening of MR. CONCLUSIONS Mitral regurgitation improvement at 3 months predicts CRT response and MR improvement at 12-month follow-up. This finding could have implications for subsequent MR surgical therapies.

Reduced incidence of esophageal lesions by luminal esophageal temperature–guided second-generation cryoballoon ablation

BACKGROUND An increased incidence of esophageal lesions (EL) after pulmonary vein isolation (PVI) using the second-generation cryoballoon (CB2) has been described. We hypothesized that luminal esophageal temperature (LET)-guided PVI reduces the incidence of EL. OBJECTIVE The aim of this study was to investigate the incidence of EL after LET-guided PVI using the CB2. METHODS Ninety-four consecutive patients underwent CB2-PVI for paroxysmal or persistent atrial fibrillation. Target freezing time was 2 × 240 seconds. LET was continuously measured by a probe with 3 thermocouples. Early freezing interruption was performed when LET reached a prespecified cutoff temperature. A group of 32 patients who underwent CB2-PVI with observational LET measurement served as the control group. Postprocedural esophagoscopy was performed in all patients. RESULTS Compared with observational LET measurement, a strategy of LET-guided CB-PVI significantly reduced the incidence of EL from 18.8% to 3.2% (P = .008). A progressive decline in the incidence of EL was observed with an increasing LET cutoff: 7.1% (2/28 patients, 12°C cutoff) and 1.5% (1/66 patients, 15°C cutoff, P = .005 vs control). Despite early freezing interruption at a single pulmonary vein in 27% (25/94) of patients, complete PVI was achieved in all patients using the 28 mm balloon. Repeat esophagoscopy confirmed healing of EL after 1 week. After a mean of 268 ± 119 days, 87% (76/87) of patients were free of recurrent atrial fibrillation or atrial tachycardia following a 90-days blanking period. CONCLUSION LET-guided CB2-PVI significantly reduced the incidence of thermal EL. Interrupting cryoablation at 15°C LET was associated with the lowest incidence of esophageal injury.

Incidence and characteristics of phrenic nerve palsy following pulmonary vein isolation with the second-generation as compared with the first-generation cryoballoon in 360 consecutive patients

AIMS The second-generation cryoballoon (CB2) with increased surface cooling has recently become available. The aim was to investigate the incidence and characteristics of phrenic nerve palsy (PNP) during pulmonary vein isolation (PVI) using the CB2 as compared with the first-generation balloon (CB1). METHODS AND RESULTS A total of 360 consecutive patients with atrial fibrillation underwent PVI with the CB1 (106 patients) or the CB2 (254 patients). Right PN function was monitored by continuous stimulation and palpation during septal PV ablation. Persistent PNP (present at discharge) occurred in 2.8 and 1.9% (P = 0.63) of patients, transient PNP (full recovery before discharge) in 5.9 and 3.8% (P = 0.41) of patients in the CB2 and CB1 group, respectively. Phrenic nerve palsy during ablation at the right inferior PV was observed in 0% (CB1) and 4.3% (CB2, P = 0.03) of patients. Using the CB2, a trend of reduced incidence of persistent PNP over quartiles of consecutive patients was observed [4.8% (Q1) vs. 0% (Q4); P = 0.077]. At the culprit PV, PNP occurred after 3.5 ± 2.1 (CB1) and 1.1 ± 0.4 applications (CB2; P = 0.036). Complete recovery of PN function occurred after 29 ± 11 (CB1) and 259 ± 137 days (CB2; P = 0.004). CONCLUSIONS The rate of transient/persistent PNP associated with the use of the CB2 was 5.9 and 2.8%, respectively. Time to restitution of PN function was longer using the CB2.

Left atrial appendage closure followed by 6 weeks of antithrombotic therapy: A prospective single-center experience

BACKGROUND Currently, 2 different left atrial appendage (LAA) closure systems are available for stroke prevention in nonvalvular atrial fibrillation but comparative data are lacking. OBJECTIVES To prospectively compare procedural data and patient outcome for 2 contemporary LAA closure systems and to investigate an alternative antithrombotic treatment regimen in high-risk patients. METHODS Patients with nonvalvular atrial fibrillation, with high risk for stroke, and who either had contraindication or were not willing to accept oral anticoagulation were prospectively enrolled. Watchman (Boston Scientific, Natick, MA; group A) or Amplatzer Cardiac Plug (St Jude Medical, Minneapolis, MN; group B) devices were implanted. All patients received antithrombotic therapy for 6 weeks. After repeat transesophageal echocardiography, patients were switched to aspirin. RESULTS Eighty patients were enrolled. There was no statistical difference in patient characteristics in groups A and B: CHA2DS2VASC score: 4.1 ± 1.5 versus 4.5 ± 1.8; HASBLED score: 3.1 ± 1.1 versus 3.1 ± 1.1, respectively. LAA closure was achieved in 78 of 80 patients (98%) (group A: 38 of 40 [95%] vs group B: 40 of 40 [100%]). There was no difference in procedure time (group A: 48 ± 16 minutes vs group B: 47 ± 15 minutes; P = .69) and fluoroscopy time (group A: 6.0 ± 4.7 minutes vs group B: 7.3 ± 4.4 minutes; P = .25). Major complications included 1 air embolism and delayed tamponade in each group. After 6 weeks, 1 device dislodgment and 4 device-related thrombi were detected. Ninety-four percent of the patients (73 of 77) were switched to aspirin after 6 weeks. During a median follow-up of 364 days (Q1-Q3: 283-539 days), no systemic embolism occurred, but 3 patients died (heart failure: n = 2; bleeding: n = 1). CONCLUSIONS Implantation of both LAA closure devices can be performed with high success rates in high-risk patients. Postprocedural 6 weeks antithrombotic therapy followed by aspirin therapy needs to be confirmed in a larger study.

CHADS2 and CHA2DS2-VASc scores to predict morbidity and mortality in heart failure patients candidates to cardiac resynchronization therapy

AIMS CHADS2 and CHA2DS2-VASc scores are pivotal in assessing the risk of stroke in atrial fibrillation patients, and were recently proved to predict hospitalizations and mortality in specific clinical settings. Aim of this study was to evaluate whether these scores could predict clinical outcomes [first hospitalization for heart failure (HF) and a combined event of HF hospitalization and death for any cause] in patients candidates to cardiac resynchronization therapy and implantable defibrillator (CRT-D). METHODS AND RESULTS In a retrospective multicentre Italian study, we enrolled 559 consecutive HF patients candidates to CRT-D, and we grouped them in three pre-specified risk classes: low (CHADS2/CHA2DS2-VASc 1-2), moderate (CHADS2/CHA2DS2-VASc 3-4), and high (CHADS2 5-6/CHA2DS2-VASc 5-8). All patients underwent regular follow-up at implanting centres every 6 months; data collection was extended till the 72th month of follow-up. At a median FU of 30 months, 143 patients (25.4%) were hospitalized for HF and 110 (19.5%) died. Event-free survival analysis showed a significant difference according to baseline CHADS2 and CHA2DS2-VASc scores (Log-Rank for HF P < 0.001 for CHADS2 and CHA2DS2-VASc; Log-Rank for combined end-point P = 0.001 for CHADS2, P < 0.001 for CHA2DS2-VASc). At multivariate analysis, independent predictors of endpoints were: previous atrial fibrillation (AF) or AF at implant, NYHA class, QRS duration and the CHA2DS2-VASc score (for HF hospitalization P = 0.013; for the combined event, P = 0.007), while the CHADS2 score was not independently associated with either the end-points. CONCLUSION In CRT-D patients, pre-implant CHA2DS2-VASc score is an independent predictor of major clinical events at 30-month follow-up.

Improved lesion formation using the novel 28 mm cryoballoon in atrial fibrillation ablation: analysis of biomarker release

AIMS Recently, a novel second-generation (G2) cryoballoon (CB) was introduced. Comparative analysis of lesion formation in terms of myocardial biomarker release [first-generation CB (G1) vs. G2] has not been studied. To compare myocardial biomarker release using the 28 mm G1 vs. G2 CB. METHODS AND RESULTS In patients (patients) treated with the simplified single big CB (SBCB) strategy for pulmonary vein isolation (PVI), myocardial biomarkers [troponin T (TnT), creatine kinase, lactic dehydrogenase (LDH)] were measured at 12, 24, and 48 h after PVI. Two groups were defined: Group 1 (G1; freezing time: 300 s), Group 2 (G2; freezing time: 240 s). Mean biomarker peak values were compared. To correct for between-group differences in cumulative freezing time, an index calculated as peak biomarker release divided by cumulative freezing time was calculated. Sixty-six CB PVI procedures (G1: 33 patients, G2: 33 patients) were analysed. Pulmonary vein isolation was achieved in all the patients using the simplified SBCB technique only. Mean freezing time (51 ± 10 vs. 33 ± 6 min, P < 0.01) was significantly shorter in G2. All biomarker levels tended to be higher in G2 vs. G1. The indexed biomarkers values were significantly higher in G2: TnT: 18.8 ± 8.5 vs. 32.3 ± 13.6 pg/L/min (P < 0.01); creatinephosphokinase: 6.7 ± 2.7 vs. 11.7 ± 3.9 U/L/min (P < 0.01); LDH: 5.2 ± 1.0 vs. 9.1 ± 2.7 U/L/min (P < 0.01). On a 6-month follow-up (180 days), G2 revealed a significantly higher success rate (20/33 vs. 28/33; P = 0.027). CONCLUSION Pulmonary vein isolation using the G2 CB increased the myocardial biomarker release index and is linked to a significantly improved 6 months success rate.

High rate of durable pulmonary vein isolation after second-generation cryoballoon ablation: analysis of repeat procedures.

AIMS Pulmonary vein isolation (PVI) using the first-generation cryoballoon (CB1) was characterized by a high rate of recovered pulmonary vein (PV) conduction along with a typical conduction gap pattern in patients with recurrent atrial tachyarrhythmia (ATa). Second generation (CB2) enables more uniform freezing. However, the rate of chronic PVI and PV conduction gap pattern is unknown. METHODS AND RESULTS All patients with ATa recurrence undergoing a second procedure after CB2 or (historical) CB1 PVI (28 mm) were enrolled. In all patients, a left atrial three-dimensional electronatomic reconstruction was performed. The rates of chronic PVI and localization of PV conduction gaps were determined and compared between CB1 and CB2. Antral PV re-isolation was performed using irrigated-tip radiofrequency current energy ablation. Of 206 patients (CB2), 18 patients underwent the repeat procedure after 192 (75:245) days. In 6 of 18 (33%) patients, all PVs were electrically isolated whereas in the remaining 12 patients (66%) at least one PV demonstrated PV reconduction. Of 71 PVs [1 left common PV (LCPV)], 55 PVs (77%) were chronically isolated. The right superior PV (RSPV) was characterized by the lowest rate of chronic PVI (RSPV: 56%, LSPV: 76%, RIPV: 83%, LIPV: 94%, LCPV: 100%). Compared with CB1, CB2 ablation resulted in a significantly higher rate of chronic PVI (CB2: 77% vs. CB1: 32%; P < 0.0001) with the greatest improvement along both inferior PVs. CONCLUSION Second-generation cryoballoon atrial fibrillation ablation is associated with a high rate of durable PVI in patients with ATa recurrence. The RSPV represents the PV with the greatest risk for left atrium-pulmonary vein reconnection.

Individualized cryoballoon energy pulmonary vein isolation guided by real-time pulmonary vein recordings, the randomized ICE-T trial

BACKGROUND The ideal energy dosing remains unclear in second-generation cryoballoon (CB) pulmonary vein isolation (PVI). We aimed to investigate the effect of an individualized dosing strategy based on time to PVI (TTI). OBJECTIVE The purpose of this study was to prospectively investigate the safety and efficacy of individualized PVI using the second-generation CB guided by real-time pulmonary vein recordings. METHODS Two groups were prospectively randomized: ICE-T group: if TTI <75 seconds, then no bonus freeze; and control group: acute PVI followed by 1 empiric bonus freeze. Freeze duration was set to 240 seconds. The primary end point was single procedure sinus rhythm after 12 months (blanking period 3 months). Secondary end points included procedural data, complications, and biomarker release. RESULTS In total, 100 patients with paroxysmal atrial fibrillation were randomized. The primary end point was not different (88% vs 82%). Procedure and fluoroscopy times were significantly shorter in the ICE-T group (70 ± 20 minutes vs 89 ± 21 minutes; P < .001 and 10.6 ± 3.9 minutes vs 12.7 ± 5.5 minutes; P = .03). More complications occurred in the control group (n = 9 vs n = 3) (persistent phrenic nerve injury: n = 1 vs n = 0; transient phrenic nerve injury: n = 5 vs n = 2; esophageal lesions: n = 3 vs n = 1). Postablation troponin T levels were not different (ICE-T group vs control group: 1035 ± 402 ng/L vs 1219 ± 509 ng/L; P = .099), whereas a significantly lower lactic acid dehydrogenase release was observed in the ICE-T group (259 ± 47 U/L vs 282 ± 57 U/L; P = .038). Multivariate analysis identified a mean TTI of >43 seconds as the only independent predictor of recurrent atrial tachyarrhythmia. CONCLUSION The individualized CB PVI strategy allows faster atrial fibrillation ablation without affecting the favorable clinical outcome. A short TTI appears to predict freedom from recurrent atrial tachyarrhythmia.

How to learn pulmonary vein isolation with a novel ablation device: learning curve effects using the endoscopic ablation system.

Novel ablation devices for pulmonary vein isolation (PVI) need a careful evaluation of its efficacy and safety beyond clinical studies in a real world situation. The endoscopic ablation system (EAS) was recently approved for PVI in Europe.

Tricuspid Annular Plane Systolic Excursion Evaluation Improves Selection of Cardiac Resynchronization Therapy Patients

The beneficial effects of cardiac resynchronization therapy (CRT) on left ventricular (LV) remodeling have been extensively described. Few data are available about the effects of CRT on right ventricular (RV) function and remodeling.