BACKGROUND—The second-generation cryoballoon is effective in achieving acute pulmonary vein isolation (PVI) and favorable clinical outcome. To date, no data are available on factors affecting late PV ...reconnection after second-generation cryoballoon ablation.
METHODS AND RESULTS—A total of 29 consecutive patients (25 male, 86.2%; mean age 57.8±13.8 years) underwent a repeat procedure, after a mean 11.6±4.5 months (range, 3.5–19.7 months), after index ablation using the 28-mm second-generation cryoballoon. All repeat ablations were performed using a 3-dimensional electroanatomical mapping system. Among all 115 PVs, including 1 left common ostiums (LCOs), 25 (21.7%) showed a PV reconnection in 20 patients (1.25 per patient). Persistent PVI could be documented in 90 of 115 PVs (78.2%). In 9 of 29 patients (31%), all PVs were electrically isolated. In the multivariable analysis, time to PVI (P=0.03) and failure to achieve −40°C within 60 s (P=0.05) independently predicted late PV reconnection. At receiver-operator curve analysis, time to PVI <60 s identified the absence of PV reconduction (sensitivity, 86.7%; specificity, 86.2%; positive predictive value, 59.1%; and negative predictive value, 96.4%; area under the curve, 0.85; confidence interval, 0.73–0.97; P<0.001).
CONCLUSIONS—The rate of late PV reconnection after second-generation cryoballoon ablation is low (1.25 PVs/patient). Faster time to isolation and achievement of −40°C within 60 s independently predict durable PVI. In addition, 60-s cut-off for time to PVI indicates persistent isolation with 96.4% negative predictive value. These parameters might guide the operator whether to perform further applications to ensure a long-lasting PVI.
Nonalcoholic fatty liver disease (NAFLD) has, although it is a very common disorder, only relatively recently gained broader interest among physicians and scientists. Fatty liver has been documented ...in up to 10 to 15 percent of normal individuals and 70 to 80 percent of obese individuals. Although the pathophysiology of NAFLD is still subject to intensive research, several players and mechanisms have been suggested based on the substantial evidence. Excessive hepatocyte triglyceride accumulation resulting from insulin resistance is the first step in the proposed 'two hit' model of the pathogenesis of NAFLD. Oxidative stress resulting from mitochondrial fatty acids oxidation, NF-kappaB-dependent inflammatory cytokine expression and adipocytokines are all considered to be the potential factors causing second hits which lead to hepatocyte injury, inflammation and fibrosis. Although it was initially believed that NAFLD is a completely benign disorder, histologic follow-up studies have showed that fibrosis progression occurs in about a third of patients. A small number of patients with NAFLD eventually ends up with end-stage liver disease and even hepatocellular carcinoma. Although liver biopsy is currently the only way to confirm the NAFLD diagnosis and distinguish between fatty liver alone and NASH, no guidelines or firm recommendations can still be made as for when and in whom it is necessary. Increased physical activity, gradual weight reduction and in selected cases bariatric surgery remain the mainstay of NAFLD therapy. Studies with pharmacologic agents are showing promising results, but available data are still insufficient to make specific recommendations; their use therefore remains highly individual.
This study was conducted to evaluate compliance with guideline-directed optimal medical therapy (OMT) and its association with early implantable cardioverter-defibrillator (ICD) activation in ...patients with heart failure and reduced ejection fraction (HFrEF).BackgroundThis study was conducted to evaluate compliance with guideline-directed optimal medical therapy (OMT) and its association with early implantable cardioverter-defibrillator (ICD) activation in patients with heart failure and reduced ejection fraction (HFrEF).Retrospective data from 307 patients who underwent ICD implantation for primary prevention from 2011 to 2017 were collected and analyzed.MethodsRetrospective data from 307 patients who underwent ICD implantation for primary prevention from 2011 to 2017 were collected and analyzed.Among the study participants, only 23.8% received the maximum tolerated dose of OMT prior to ICD implantation, with 59.0% receiving all three OMT medication groups. No significant difference in OMT compliance was found between patients with ischemic cardiomyopathy (ICM) and those with non-ischemic dilated cardiomyopathy (DCM). However, DCM patients received ICDs more frequently at the time of diagnosis than ICM patients (13.8% vs. 0.7%). Early ICD activation (within 3 months) occurred in only one patient who had not received appropriate OMT, representing 0.7% of all ICM patients. Furthermore, early activation was also infrequent in patients who received OMT (2.9% of ICM patients and 2.6% of DCM patients). Echocardiography follow-up data revealed that 20.4% of ICM patients and 29.8% of DCM patients who did not receive OMT before ICD implantation showed improvement in the left ventricular ejection fraction (EF) to 35% or more.ResultsAmong the study participants, only 23.8% received the maximum tolerated dose of OMT prior to ICD implantation, with 59.0% receiving all three OMT medication groups. No significant difference in OMT compliance was found between patients with ischemic cardiomyopathy (ICM) and those with non-ischemic dilated cardiomyopathy (DCM). However, DCM patients received ICDs more frequently at the time of diagnosis than ICM patients (13.8% vs. 0.7%). Early ICD activation (within 3 months) occurred in only one patient who had not received appropriate OMT, representing 0.7% of all ICM patients. Furthermore, early activation was also infrequent in patients who received OMT (2.9% of ICM patients and 2.6% of DCM patients). Echocardiography follow-up data revealed that 20.4% of ICM patients and 29.8% of DCM patients who did not receive OMT before ICD implantation showed improvement in the left ventricular ejection fraction (EF) to 35% or more.This study found suboptimal compliance with OMT prior to ICD implantation in HFrEF patients. The results showed that early ICD activation was rare in all patient groups, especially those who did not receive the prescribed 3 months of OMT. More research is needed to investigate longer waiting periods for the evaluation of potential EF improvement, and to better evaluate the eligibility of HFrEF patients for ICD. The current findings have potential implications for clinical practice and patient outcomes.ConclusionsThis study found suboptimal compliance with OMT prior to ICD implantation in HFrEF patients. The results showed that early ICD activation was rare in all patient groups, especially those who did not receive the prescribed 3 months of OMT. More research is needed to investigate longer waiting periods for the evaluation of potential EF improvement, and to better evaluate the eligibility of HFrEF patients for ICD. The current findings have potential implications for clinical practice and patient outcomes.
The second-generation cryoballoon (CB-Adv) is effective in achieving pulmonary vein isolation (PVI) with encouraging results. The mid-term clinical efficacy of a single 3-minute freeze, without a ...routine bonus application, has been recently demonstrated.
The purpose of this study was to assess long-term clinical outcome after PVI with the CB-Adv using a single 3-minute application.
A total of 143 consecutive patients (93 male 65%, mean age 59.6 ± 12.0 years) with paroxysmal atrial fibrillation (PAF; 113/143 79%) or early persistent atrial fibrillation (AF; 30/143 21%) underwent PVI using CB-Adv with a single 3-minute freeze. Atrial tachyarrhythmia recurrences were defined as symptomatic or documented episodes >30 seconds.
After a single freeze, isolation could be reached in 94.1% of all identified pulmonary veins. Complete PVI was successfully achieved with 1.1 ± 0.4 mean freezes. Persistent phrenic nerve palsy occurred in 5 of 143 patients (3.5%). At a mean 12.1 ± 4.4 months of follow-up, after a 3-month blanking period (BP), 80.4% (115/143) were in stable sinus rhythm (93/113 82.3% for PAF; 22/30 73.3% for early persistent AF). Fifteen patients underwent a second procedure with radiofrequency ablation showing reconnection in 7 of 15 right-sided (46.7%) and 6 of 15 left-sided (40%) pulmonary veins. Relapses during BP (P <.01), time to PVI (P = .02), and longer AF duration (P = .04) were independent predictors of recurrences.
A single 3-minute freeze is highly effective, determining an atrial tachyarrhythmia freedom of 80.4% at 1-year follow-up. The incidence of persistent phrenic nerve palsy is 3.5%. Relapses during BP, time to PVI, and longer AF duration are predictors of recurrences. Routine use of an "insurance freeze" may not be needed.
Cryoenergy Interruption Due to Phrenic Nerve Palsy
Introduction
Right phrenic nerve paralysis (PNP) is the most frequently observed complication occurring during cryoballoon ablation (CB). Our aim ...was to analyze the impact of the premature interruption (PI) of cryoenergy delivery in a large series of consecutive patients during ablation in the right‐sided veins on clinical outcome.
Methods and Results
All consecutive patients having undergone second‐generation CB ablation for paroxysmal atrial fibrillation (AF) from July 2012 to September 2014 were included in our analysis. Exclusion criteria were persistent AF, presence of an intracavitary thrombus, uncontrolled heart failure, moderate or severe valvular disease, left atrium (LA) diameter ≥55 mm, and contraindications to general anesthesia. A total 287 consecutive patients with drug‐resistant paroxysmal AF having undergone pulmonary vein isolation by means of CB technology (male 65%, age 57.6 ± 13.1 years) were included. The incidence of PNP in the study population was 8.0% (23/287). At a mean follow‐up of 11.5 ± 3.9 months, the success rate without antiarrhythmic therapy was 81.6%. Patients with PNP had similar rates of AF recurrence compared with those without PNP (17.4% vs. 17.8%; P = 0.9); the former had a mean follow‐up of 10.9 ± 3.7 months, the latter 11.8 ± 4.5 months (P = 0.3).
Conclusion
Conclusion: Our findings show that patients in whom freezing was interrupted due to PNP had a similar outcome on 1‐year follow‐up compared with those in whom freezing cycles were completed in the septal veins. No baseline clinical or procedural characteristics were found to predict AF recurrence in patients having experienced PNP.
To study the learning curve with the second-generation cryoballoon technology focusing on safety, efficacy and procedural characteristics.
We included 300 patients (men 64.6%, mean age 58.3 ± 12.4 ...years), 240 of whom were treated by four operators without prior experience in atrial fibrillation ablation and compared them with 60 consecutive patients treated by senior operator. To study the learning curves, we divided the study period into two trimesters and analyzed procedure duration, fluoroscopy times, complications, characteristics of the freeze-thaw cycles and midterm outcomes.
Hands-on help from senior operators to achieve pulmonary vein isolation was needed only in the first study trimester (24.1%), most commonly to achieve right inferior pulmonary vein isolation (55.2%). The mean procedure duration shortened from 76.7 ± 17.4 to 65.1 ± 11.4 min (P < 0.0001), and fluoroscopy time decreased from 18.5 ± 7.3 to 12.1 ± 4.3 min (P < 0.0001) for first and second trimester, respectively, and approached senior operator's results (58.2 ± 12.8 and 8.7 ± 4.5 min). Most of the major complications (one stroke, four pseudoaneurysms and one retroperitoneal hematoma) occurred during the first study trimester. Most characteristics of the freeze cycles remained unchanged in both study periods. Compared with junior operators, the senior operator achieved lower nadir temperatures in both inferior veins. However, there was no significant difference in midterm outcomes between junior and senior operators (79.5 vs 83.3%, P = 0.589).
The learning curve with the second-generation cryoballoon is steep. Inexperienced operators, trained in high-volume centers, can achieve pulmonary vein isolation safely and efficiently with short procedure and fluoroscopy times after having performed 20-30 cases.
The predictive value of induction studies after catheter ablation for atrial fibrillation (AF) is still debatable. To date, these studies have not been implemented in patients after cryoballoon (CB) ...ablation. Our aim was to analyse the clinical value of AF induction in patients treated by second generation CB for paroxysmal AF.
Seventy patients underwent at first an isoproterenol challenge after pulmonary vein (PV) isolation to assess AF induction and early PV reconnections (EPVR). Patients without EPVR were evaluated for premature atrial contraction (PAC) induction; atrial ectopy was considered frequent (PAC+) if >1/10 cycles or >6/min. After restitution of baseline heart rate, rapid atrial pacing (RAP) was performed on all patients. AF induction by isoproterenol occurred only in 3/70 (4%) patients of whom 2/3 (66%) patients with an EPVR of a triggering vein. In the 62 patients without EPVR, PAC+ occurred in 17 patients (27%). RAP could induce AF in 23/70 (33%) patients. At a mean follow-up of 13.5 months, there were 11/70 (16%) AF recurrences. There was no significant difference in the AF recurrence rate between RAP inducible vs. non-inducible patients (log-rank P = 0.33). A 41% recurrence rate (7/17 patients) was seen in the PAC+ group with significantly different AF-free survival for PAC+ vs. PAC- patients (log rank P < 0.0001). PAC+ was the only independent determinant to predict AF recurrence after multivariate analysis.
PAC occurrence in response to isoproterenol could predict AF recurrence after PV isolation by CB, while RAP showed no prognostic implication.
To investigate the association between depression, metabolic syndrome (MBS), somatic, particularly cardiovascular comorbidity, and low-grade chronic inflammation assessed using C-reactive protein ...(CRP).
This cross-sectional study included 76 patients with recurrent depressive disorder (RDD) and 72 non-depressed medical staff controls from the Department of Psychiatry, University Hospital Center Zagreb between January 2011 and June 2012.
Seventy-five percent of patients had somatic comorbidity. The most common comorbid conditions were cardiovascular disorders (46.1%), locomotor system diseases (35.5%), carcinoma (15.8%), thyroid diseases (9.2%), and diabetes (9.2%). MTB was more common in RDD patients (31.6%) than in controls (23.6%), but the difference was not significant. Elevated CRP was found to be significantly more frequent in patients with recurrent depressive disorders (RDD) (35.5%; χ(2) test, P=0.001, Cramer V=0.29) than in controls (12.5%) and was associated with lowered high-density lipoprotein and overweight/obesity.
We found some intriguing links between stress, depression, metabolic syndrome, and low grade inflammation, which may be relevant for the prevalence of somatic comorbidity in patients with RDD, but further studies are needed to confirm our results.