Leadless pacemaker implant with concomitant atrioventricular node ablation: Experience with the Micra transcatheter pacemaker.

BACKGROUND: The feasibility and outcomes of concomitant atrioventricular node ablation (AVNA) and leadless pacemaker implant are not well studied. We report outcomes in patients undergoing Micra implant with concomitant AVNA. METHODS: Patients undergoing AVNA at the time of Micra implant from the Micra Transcatheter Pacing (IDE) Study, Continued Access (CA) study, and Post-Approval Registry (PAR) were included in the analysis and compared to Micra patients without AVNA. Baseline characteristics, acute and follow-up outcomes, and electrical performance were compared between patients with and without AVNA during the follow-up period. RESULTS: A total of 192 patients (mean age 77.4 ± 8.9 years, 72% female) underwent AVNA at the time of Micra implant and were followed for 20.4 ± 15.6 months. AVNA patients were older, more frequently female, and tended to have more co-morbid conditions compared with non-AVNA patients (N = 2616). Implant was successful in 191 of 192 patients (99.5%). The mean pacing threshold at implant was 0.58 ± 0.35 V and remained stable during follow-up. Major complications within 30 days occurred more frequently in AVNA patients than non-AVNA patients (7.3% vs. 2.0%, p < .001). The risk of major complications through 36-months was higher in AVNA patients (hazard ratio: 3.81, 95% confidence interval: 2.33-6.23, p < .001). Intermittent loss of capture occurred in three AVNA patients (1.6%), all were within 30 days of implant and required system revision. There were no device macrodislodgements or unexpected device malfunctions. CONCLUSION: Concomitant AVN ablation and leadless pacemaker implant is feasible. Pacing thresholds are stable over time. However, patient comorbidities and the risk of major complications are higher in patients undergoing AVNA.

Cholinergic activity regulates the secretome of epicardial adipose tissue: Association with atrial fibrillation.

Botulinum toxin injection on epicardial fat, which inhibits acetylcholine (ACh) release, reduced the presence of atrial fibrillation (AF) in patients after heart surgery. Thus, we wanted to study the profile of the released proteins of epicardial adipose tissue (EAT) under cholinergic activity (ACh treatment) and their value as AF predictors. Biopsies, explants, or primary cultures were obtained from the EAT of 85 patients that underwent open heart surgery. The quantification of muscarinic receptors (mAChR) by real-time polymerase chain reaction or western blot showed their expression in EAT. Moreover, mAChR Type 3 was upregulated after adipogenesis induction (p < 0.05). Cholinergic fibers in EAT were detected by vesicular ACh transporter levels and/or acetylcholinesterase activity. ACh treatment modified the released proteins by EAT, which were identified by nano-high-performance liquid chromatography and TripleTOF analysis. These differentially released proteins were involved in cell structure, inflammation, or detoxification. After testing the plasma levels of alpha-defensin 3 (inflammation-involved protein) of patients who underwent open heart surgery ( n = 24), we observed differential levels between the patients who developed or did not develop postsurgery AF (1.58 ± 1.61 ng/ml vs. 6.2 ± 5.6 ng/ml; p < 0.005). The cholinergic activity on EAT might suggest a new mechanism for studying the interplay among EAT, autonomic nervous system dysfunction, and AF.

Prognostic value of nutrition status in the response of cardiac resynchronization therapy.

BACKGROUND: Cardiac resynchronization therapy (CRT) is indicated in symptomatic heart failure (HF) patients after achieving optimal medical therapy. However, there are still a large percentage of patients who do not respond to CRT. Malnutrition is a frequent comorbidity in patients with HF, and it is associated with a poorer prognosis. Here, we evaluate the nutritional status of patients assessed by Controlling Nutritional Status (CONUT) score and its association with structural remodeling and cardiovascular events. METHODS: We investigated the effect of CONUT on HF/death in 302 consecutive patients with a CRT device implanted between 2005 and 2015 in a single tertiary center. We categorized the patients into three groups: normal nutritional status (CONUT 0-1), mild malnutrition (CONUT 2-4) and moderate-severe malnutrition (CONUT ≥ 5). Changes in nutritional status were assessed in patients with mild-to-severe malnutrition prior to CRT. RESULTS: One hundred and forty-eight patients exhibited normal nutritional status (49.0%), 99 patients exhibited mild malnutrition (32.8%) and 55 patients exhibited moderate-severe malnutrition (18.2%). CONUT scores of at least 2 were associated with higher risk of HF/death compared with CONUT 0-1. Significant left ventricular (LV) reverse remodeling was noted in patients with better nutritional status. In addition, those malnutrition patients at baseline that improved nutritional state exhibited fewer HF/death events at follow-up. CONCLUSION: CONUT score prior to CRT was an independent risk factor of death/HF and was correlated with LV reverse remodeling. Improvements in CONUT score during long-term follow-up were associated with a reduction in the rate of HF/death.

New oral anticoagulants vs vitamin K antagonists: benefits for health-related quality of life in patients with atrial fibrillation.

New oral anticoagulants (NOAC) have demonstrated their efficacy as an alternative to vitamin K antagonists (VKA) in the prophylaxis of cardioembolic events in patients with atrial fibrillation (AF). However, evidence on the benefits of NOAC in health-related quality of life (HRQoL) is lacking.We evaluated changes in HRQoL related to oral anticoagulation therapy employing a specific questionnaire in a cohort of 416 patients with AF undergoing electrical cardioversion. In terms of HRQoL, we observed a progressive adaptation to treatment with VKA; satisfaction with NOAC remained constant. Older age, higher left ventricular ejection fraction and NOAC were associated with better HRQoL.

Health-related quality of life in different clinical subgroups with typical AFL who have undergone cavo-tricuspid isthmus ablation.

BACKGROUND: To evaluate changes in health-related quality of life (HRQOL) in different sub-groups of a cohort of patients with typical atrial flutter (AFL) treated with cavotricuspid isthmus (CTI) radiofrequency catheter ablation. METHODS: 95 consecutive patients due to undergo CTI ablation were enrolled in a study involving their completion of two SF-36 HRQOL questionnaires, before ablation and at one-year follow-up. RESULTS: 88 of the initial 95 patients finished the study. Regardless of whether patients experienced atrial fibrillation (AF) during follow-up, a statistically significant improvement in HRQOL was observed, compared with pre-ablation scores and in all dimensions except Bodily Pain. However, patients without AF during follow-up had significantly higher absolute HRQOL scores in most dimensions. No differences were seen in most HRQOL dimensions, with respect to AFL type (paroxysmal, persistent) or duration, whether AFL was first-episode or recurrent, Class I-III drug dependent, sex, or presence of structural heart disease or tachycardiomyopathy. Patients with persistent AFL showed the greatest improvement in HRQOL when they also had a ventricular cycle length ≤500 ms. The combination of recurrent AFL, ventricular cycle length ≤500 ms and structural heart disease led to a significantly greater improvement in physical HRQOL dimensions than did first-episode AFL, no structural heart disease and ventricular cycle >500 ms. The only independent factor associated with a greater improvement was structural cardiopathy. CONCLUSIONS: CTI-ablation treatment leads to a significant improvement in HRQOL in patients with typical AFL. Patients with AF during follow-up show a significantly lower HRQOL at one-year post-ablation. The only independent risk factor found to be associated with a greater improvement in the physical summary component was structural cardiopathy.

Long-term cardiac reverse remodeling after cardiac resynchronization therapy.

INTRODUCTION: The benefit of cardiac resynchronization therapy (CRT) in heart failure (HF) patients with reduced left ventricular ejection fraction (LVEF) have been observed in the first year. However, there are few data on long-term follow-up and the effect of changes of LVEF on mortality. This study aimed to assess the LV remodeling after CRT implantation and the probable effect of changes in LVEF with repeated measures on mortality over time in a real-world registry. METHODS: Among our cohort of 328 consecutive CRT patients, mixed model effect analysis have been made to describe the temporal evolution of LVEF and LVESV changes over time up with several explanatory variables. Besides, the effect of LVEF along time on the probability of mortality was evaluated using joint modeling for longitudinal and survival data. RESULTS: The study population included 328 patients (253 men; 70.2 ± 9.5 years) in 4.2 (2.9) years follow-up. There was an increase in LVEF of 11% and a reduction in LVESV of 42 mL during the first year. These changes are more important during the first year, but slight changes remain during the follow-up. The largest reduction in LVESV occurred in patients with left bundle branch block (LBBB) and the smallest reduction in patients with NYHA IV. The smallest increase in LVEF was an ischemic etiology, longer QRS, and LV electrode in a nonlateral vein. Besides, the results showed that the LVEF profiles taken during follow-up after CRT were associated with changes in the risk of death. CONCLUSION: Reverse remodeling of the left ventricle is observed especially during the first year, but it seems to be maintained later after CRT implantation in a contemporary cohort of patients. Longitudinal measurements could give us additional information at predicting the individual mortality risk after adjusting by age and sex compared to a single LVEF measurement after CRT.

Cardiac resynchronization therapy outcomes in patients under nonoptimal medical therapy.

BACKGROUND: Cardiac resynchronization therapy (CRT) is indicated in symptomatic heart failure (HF) patients after achieving optimal medical therapy (OMT). However, many patients may not be under OMT when the CRT device is implanted. Here, we evaluate the long-term benefits of CRT in symptomatic HF patients receiving or not OMT. METHODS: We investigated the effect of OMT on HF developing or death in 328 consecutive patients with a CRT device implanted between 2005 and 2015 in a single tertiary center. After the CRT implant, we categorized the patients into three groups: no OMT, OMT at baseline and after 1 year of follow-up, and OMT only at the 1-year follow-up but not at baseline. We used multivariate Cox proportional hazards model to determine the effect of OMT on clinical outcomes. RESULTS: One hundred and twenty-two patients (37.2%) received OMT prior to CRT. OMT at baseline was not associated with a reduced risk of death or HF (HR 0.72; 95% CI 0.50-1.02; P = 0.067) compared with no-basal-OMT patients. After CRT, patients without OMT had a higher risk of death or HF than patients who received OMT in follow-up (HR 1.72, 95% CI 1.07-2.78, P = 0.025), and the risk of the patients who received OMT at baseline and at the 1-year follow-up was similar to that of the patients who achieved OMT at the 1-year follow-up (HR 0.90, 95% CI 0.54-1.50, P = 0.682). CONCLUSION: Basal OMT prior to CRT is not associated with better outcomes in terms of HF/death compared with no basal OMT. The subgroup of patients who achieved OMT at the 1-year follow-up exhibited a reduced risk of HF and death compared with patients who did not.

Cardiac resynchronization therapy response in heart failure patients with different subtypes of true left bundle branch block.

PURPOSE: Left bundle branch block (LBBB) configuration has been described as a predictor of response to cardiac resynchronization therapy (CRT). We investigated whether different subtypes of true LBBB configuration could help select patients with better response and clinical outcome. METHODS: This retrospective study included 198 consecutive LBBB patients implanted with a CRT. True LBBB was defined using the Strauss and the Predict study criteria. Echocardiographic response was evaluated by the reduction in left ventricular end-systolic volume (LVESV) and the increase in left ventricular ejection fraction (LVEF). Clinical response was defined as an improvement in one category of the NYHA functional class. RESULTS: Patients with true LBBB had a greater improvement in both LVESV reduction (median = - 27.6%, interquartile range = [- 4.9, - 50.1]) and LVEF increase (median 10.8 ± 10) than those with non-true LBBB (- 19.7%, [16.7, - 48.0]) p = 0.04 and 5.1 ± 10, p = 0.03, respectively. No differences were exhibited between true LBBB Strauss group (- 26.7%, [- 11.0, - 46.9]) and true LBBB Predict group (- 26.6%, [- 15.9, - 39.4]). There were no statistically significant differences in the percentage of patients with clinical response, assessed by NYHA improvement, among all groups. In the Cox model for death, age, ischemic etiology, and ΔLVESV were independent predictors of mortality. True LBBB (Strauss + Predict) patients had a trend towards lower mortality than non-true LBBB [HR = 0.55, 95% CI = (0.22-1.15)], p = 0.08. In the Cox model for HF hospitalization, age, sex male, prior LVEF, and ΔLVESV were independent predictors. True LBBB (Strauss + Predict) patients had a significantly lower risk of developing HF hospitalization than those with non-true LBBB [0.45 (0.21-0.90)], p = 0.029. CONCLUSIONS: Patients with true LBBB, either Strauss or Predict criteria, had greater echocardiographic response and lower incidence of HF hospitalization than non-true LBBB when implanted with CRT.

Is HATCH score a reliable predictor of atrial fibrillation after cavotricuspid isthmus ablation for typical atrial flutter?

OBJECTIVE: We determined the effectiveness of the HATCH score in patients with typical atrial flutter (AFl) undergoing cavotricuspid isthmus (CTI) ablation to predict long-term atrial fibrillation (AF). METHODS: We conducted an observational retrospective single-center cohort study including all patients admitted to our hospital for a CTI ablation between 1998 and 2010. The patients were divided into four categories: 1) new-onset AF (no prior AF and AF during follow-up (FU)); 2) old AF (prior AF and no AF during FU); 3) prior and post AF (AF prior and post CTI ablation); and 4) no AF. RESULTS: Four hundred and eight patients were included. In patients without prior AF, the hazard ratio (HR) for new-onset AF during FU was 0.98 (CI 95%: 0.65-1.50; p = 0.95) and 1.00 (CI 95%: 0.57-1.77; p = 0.98) for HATCH ≥ 2 and HATCH ≥ 3, respectively. In patients with prior AF, the HR for AF was 1.41 (CI 95%: 0.87-2.28; p = 0.17) and 1.79 (CI 95%: 0.96-3.35; p = 0.06), for HATCH ≥ 2 and HATCH ≥ 3, respectively. Left atrial enlargement was positively correlated with the occurrence of AF during FU, especially in the subgroup without prior AF, which had a HR of 2.44 (CI 95%: 1.35-4.40; p = 0.003), a HR of 2.88 (CI 95%: 1.36-6.10; p = 0.006) and a HR of 3.68 (CI 95%: 1.71-7.94; p = 0.001), for slight, moderate and severely dilated left atrial dimension, respectively, compared with a normal value. CONCLUSIONS: HATCH score did not predict AF in patients with typical AFl who underwent CTI ablation. Basal left atrium dimension could help predict new-onset AF.

Failure of hybrid therapy for the prevention of long-term recurrence of atrial fibrillation.

OBJECTIVES: To determine the long-term effectiveness of hybrid therapy in the control of atrial fibrillation (AF) as well as the differences in clinical outcomes between patients with antiarrhythmic drug atrial flutter (AAD-AFl), those with coexistent AFl and AF, and isolated AFl. METHODS: Four hundred eight patients who consecutively underwent cavotricuspid isthmus (CTI) ablation between 1998 and 2010 were followed for 5.9 years. Twenty-seven patients had AAD-AF1 (Group 1): they had AF but not AFl at baseline but on AAD therapy they showed typical AFl. They underwent CTI ablation and continued with AAD therapy, 96 patients had coexistent AF1 and AF at baseline (Group 2) and continued with AAD therapy at the discretion of their cardiologists and 284 patients had isolated AFl (Group 3). RESULTS: AF recurred in the majority of the AAD-AF1 patients (74%, incident density rate (IDR): 19.1/100 person-years). This incidence rate was similar to the recurrence rate of AF in patients with coexistent AFl and AF (59%, IDR: 19.2/100 person-years). The patients in Group 1 had a similar IDR of stroke as Group 2 and a slightly higher rate than Group 3. There were no significant differences in the IDR for death among Groups 1, 2 and 3. CONCLUSIONS: Hybrid therapy was not effective for long-term control of AF. The clinical outcomes (AF, stroke and death) were similar for AAD-AF1 patients and patients with coexistent AF and AFl.

Structural and functional inverse cardiac remodeling after cavotricuspid isthmus ablation in patients with typical atrial flutter.

INTRODUCTION AND OBJECTIVES: The purpose of the present study is to determine the structural and functional cardiac changes that occur in patients at 1-year follow-up after ablation of typical atrial flutter. METHODS: We enrolled 95 consecutive patients referred for cavotricuspid isthmus ablation. Echocardiography was performed at ≤6h post-procedure and 1-year follow-up. RESULTS: Of 95 patients initially included, 89 completed 1-year follow-up. Hypertensive cardiopathy was the most frequently associated condition (39%); 24% of patients presented low baseline left ventricular systolic dysfunction. We observed a significant reduction in right and left atrial areas, end-diastolic and end-systolic left ventricular diameters, and interventricular septum. We observed substantial improvement in right atrium contraction fraction and left ventricular ejection fraction, and a reduction in pulmonary hypertension. Changes in diastolic dysfunction pattern were observed: 60% of patients progressed from baseline grade III to grade I; at 1-year follow-up, this improvement was found in 81%. We found no structural differences between paroxysmal and persistent atrial flutter at baseline and 1-year follow-up, exception for basal diastolic function. CONCLUSIONS: In patients with typical atrial flutter undergoing cavotricuspid isthmus catheter ablation, we found inverse structural and functional cardiac remodeling at 1-year follow-up with much improved left ventricular ejection fraction, right atrium contraction fraction, and diastolic dysfunction pattern. Full English text available from:www.revespcardiol.org.

Influence of the preimplantation QRS axis on responses to cardiac resynchronization therapy.

INTRODUCTION AND OBJECTIVES: The aim of this study was to determine whether measurement of the QRS axis can help to predict outcome in patients undergoing cardiac resynchronization therapy. METHODS: The study included 78 patients who had undergone successful cardiac resynchronization device implantation. Patients were classified as having either a normal QRS axis (i.e., between -30 degrees and +120 degrees) or a left QRS axis deviation (i.e., between -30 degrees and -90 degrees). Patients were regarded as responders if they fulfilled all of the following criteria: their functional class improved by at least one grade, their left ventricular ejection fraction increased by at least 5%, they did not need hospitalization for worsening heart failure, and they were still alive at 12-month follow-up. RESULTS: After adjustment for age, preimplantation left ventricular ejection fraction, etiology and mitral regurgitation, a statistically significant interaction was found between the QRS axis and lead location (P=.026). There was a better response with an anterior lead location if the patient had a left QRS axis deviation. CONCLUSIONS: A significant interaction was found between the lead location and the preimplantation QRS electrical axis, such that there was a better response to resynchronization therapy when the lead was implanted in the anterior interventricular vein if the patient had a left QRS axis deviation.

[Clinical characteristics of patients with persistent atrial fibrillation referred for cardioversion: Spanish Cardioversion Registry (REVERSE)]. / Perfil clínico de los pacientes con fibrilación auricular persistente remitidos a cardioversión: Registro sobre la cardioversión en España (REVERSE).

The objectives were to investigate the treatment and clinical characteristics of patients referred for cardioversion in Spain and to compare them with those reported in the AFFIRM (Atrial Fibrillation Follow-up Investigation of Rhythm Management) and RACE (RAte Control versus Electrical cardioversion) studies. The prospective study involved 1515 consecutive patients with persistent atrial fibrillation who were referred for cardioversion at 96 Spanish hospitals. Half of the patients were being treated with Vaughan-Williams group-I or -III antiarrhythmic drugs. The most frequently used approach to anticoagulation was to administer dicoumarins 34 weeks before and after cardioversion. Our patients were younger than those in the AFFIRM and RACE studies. Compared with AFFIRM patients, our patients had a lower prevalence of previous embolism, ischemic heart disease, hypertension, diabetes, and systolic dysfunction. Compared with RACE patients, our patients had a lower prevalence of ischemic heart disease and previous embolism, but a slightly higher prevalence of hypertension and diabetes. We conclude that patients referred for cardioversion in Spain clearly had a lower cardiovascular risk profile than those in the AFFIRM study, and appeared to have a lower risk profile than those in the RACE study.