Time to -30°C as a predictor of acute success during cryoablation in patients with atrial fibrillation.

BACKGROUND: Freezing rate of second-generation cryoballoon (CB) is a biophysical parameter that could assist pulmonary vein isolation. The aim of this study is to assess freezing rate (time to reach -30°C ([TT-30C]) as an early predictor of acute pulmonary vein isolation using the CB. METHODS: Biophysical data from CB freeze applications within a multicenter, nation-wide CB ablation registry were gathered. Successful application (SA), was defined as achieving durable intraprocedural vein isolation. And SA with time to isolation under 60 s (SA-TTI<60) as achieving durable vein isolation in under 60 s. Logistic regressions were performed and predictive models were built for the data set. RESULTS: 12,488 CB applications from 1,733 atrial fibrillation (AF) ablation procedures were included within 27 centers from a Spanish CB AF ablation registry. SA was achieved in 6,349 of 9,178 (69.2%) total freeze applications, and SA-TTI<60 was obtained in 2,673 of 4,784 (55.9%) freezes where electrogram monitoring was present. TT-30C was shorter in the SA group (33.4 ± 9.2 vs 39.3 ± 12.1 s; p < 0.001) and SA-TTI<60 group (31.8 ± 7.6 vs. 38.5 ± 11.5 s; p < 0.001). Also, a 10 s increase in TT-30C was associated with a 41% reduction in the odds for an SA (odds ratio [OR] 0.59; 95% confidence interval [CI] 0.56-0.63) and a 57% reduction in the odds for achieving SA-TTI<60 (OR 0.43; 95% CI 0.39-0.49), when corrected for electrogram visualization, vein position, and application order. CONCLUSIONS: Time to reach -30°C is an early predictor of the quality of a CB application and can be used to guide the ablation procedure even in the absence of electrogram monitoring.

Cryoballoon Ablation for Persistent and Paroxysmal Atrial Fibrillation: Procedural Differences and Results from the Spanish Registry (RECABA).

Introduction: Cryoballoon ablation (CBA) has become a standard treatment for paroxysmal atrial fibrillation (PaAF) but limited data is available for outcomes in patients with persistent atrial fibrillation (PeAF). Methods: We analyzed the first 944 patients included in the Spanish Prospective Multi-center Observation Post-market Registry to compare characteristics and outcomes of patients undergoing CBA for PeAF versus PaAF. Results: A total of 944 patients (57.8 ± 10.4 years; 70.1% male) with AF (27.9% persistent) were prospectively included from 25 centers. PeAF patients were more likely to have structural heart disease (67.7 vs. 11.4%; p < 0.001) and left atrium dilation (72.6 vs. 43.3%; p < 0.001). CBA of PeAF was less likely to be performed under general anesthesia (10.7 vs. 22.2%; p < 0.001), with an arterial line (32.2 vs. 44.6%; p < 0.001) and assisted transeptal puncture (11.9 vs. 17.9%; p = 0.025). During an application, PeAF patients had a longer time to −30 °C (35.91 ± 14.20 vs. 34.93 ± 12.87 s; p = 0.021) and a colder balloon nadir temperature during vein isolation (−35.04 ± 9.58 vs. −33.61 ± 10.32 °C; p = 0.004), but received fewer bonus freeze applications (30.7 vs. 41.1%; p < 0.001). There were no differences in acute pulmonary vein isolation and procedure-related complications. Overall, 76.7% of patients were free from AF recurrences at 15-month follow-up (78.9% in PaAF vs. 70.9% in PeAF; p = 0.09). Conclusions: Patients with PeAF have a more diseased substrate, and CBA procedures performed in such patients were more simplified, although longer/colder freeze applications were often applied. The acute efficacy/safety profile of CBA was similar between PaAF and PeAF patients, but long-term results were better in PaAF patients.

Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study.

Cryoablation is safe and effective for the treatment of atrial fibrillation (AF) in controlled clinical trials, but contemporary real-world usage and outcomes are limited. The Report of the Spanish Cryoballoon Ablation Registry (RECABA) was designed to evaluate acute and 12-month outcomes of cryoballoon ablation for the treatment of AF in Spain. Patients from 27 Spanish centers were prospectively enrolled. Patients were treated with cryoballoon ablation and managed according to standard of care protocols at each center. The primary endpoint was ≥ 30 s freedom from AF at 12-month after a 3-month blanking period. Secondary endpoints included a description of patient characteristics, cryoablation procedural strategy and safety, and predictors of efficacy. In total, 1742 patients (71.4% PAF, 68.8% male, mean age 58.02 ± 10.40 years, 76.1% overweight or obese, CHA2DS2-VASc index 1.40 ± 1.28) were enrolled. Patients received 7.2 ± 2.67 cryo-applications. PV potentials could be detected in 61% of the PVs during ablation, with a mean time to block of 52.9 ± 37.02 s. Acute PVI was observed in 97% of PVs with 75.8% isolated with the first cryo-application. Mean procedural time was 113 ± 41 min. Acute complications occurred in 4.4% of the cases. With follow-up in 1628 patients, AF-free survival was 78.5% (PAF: 80.6% vs PersAF 73.3%; p < 0.001). Left atrium enlargement, female sex, non-PAF, and early recurrence were independent predictors of AF recurrence (p < 0.05). RECABA provides detailed insight into current dosing practices and demonstrates cryoablation is safe and effective in real-world use.ClinicalTrials.gov number: NCT02785991.

Antisclerothic effect of tibolone by reducing proinflammatory cytokines expression, ROS production and LDL-ox uptake in THP-1 macrophages.

BACKGROUND: Cardiovascular disease is more frequent in menopausal women, which has been related to factor such as weight gain, altered fat distribution, and increased inflammation markers including adipokines (MCP-1, TNF-α, IL-6) and cytokines (IL-1, IL-6, TNF-α) produced by macrophages. In addition to their phagocytic activity, macrophages secrete cytokines and chemokines that induces cell recruitment, which is a process related to vascular damage that favors the formation of atheromatous plaques. Tibolone (Tb) therapy is used to reduce the symptoms of menopause as well as osteoporosis and it has been shown to decreases the risk of fractures. METHODS: To investigate the effect of tibolone in macrophage enzymatic activity, gene expression of cytokines, and its effect on foam cells formation. We use phorbol-12-myristate-13-acetate (PMA)-differentiated THP-1 cells. The cells were incubated 24 h and 48 h using pre and post-treatment schemes. We evaluated total ROS determination by NBT assay, expression of cytokines (IL-1ß, IL-6, TNF-α, NOS2, ARG1, TGFß) by RT-qPCR and foam cell formation in THP-1 differentiated macrophages stimulated with PMA. RESULTS: It was observed that the minor levels of total ROS determination were obtained with tibolone at 48 h in post-treatment scheme. Also, in a long term we found decrease the proinflammatory cytokines (IL-1ß, IL-6 and TNF-α). Finally, with treatment for 24 h with P4 y Tb we observed fewer LDL vesicles into macrophages cytoplasm. CONCLUSIONS: These results suggest that tibolone reduces the inflammatory process, also inhibits the foam cells formation; suggesting a possible role in reducing cardiovascular risk.

Infectious Agents in Childhood Leukemia.

Acute leukemia is the most common pediatric cancer, representing one-third of all cancers that occurs in under 15 year olds, with a varied incidence worldwide. Although a number of advances have increased the knowledge of leukemia pathophysiology, its etiology remains less well understood. The role of infectious agents, such as viruses, bacteria, or parasites, in the pathogenesis of leukemia has been discussed. To date, several cellular mechanisms involving infectious agents have been proposed to cause leukemia following infections. However, although leukemia can be triggered by contact with such agents, they can also be beneficial in developing immune stimulation and protection despite the risk of leukemic clones. In this review, we analyze the proposed hypotheses concerning how infectious agents may play a role in the origin and development of leukemia, as well as in a possible mechanism of protection following infections. We review reported clinical observations associated with vaccination or breastfeeding, that support hypotheses such as early life exposure and the resulting early immune stimulation that lead to protection.

The Impact of Cryoballoon Versus Radiofrequency Ablation for Paroxysmal Atrial Fibrillation on Healthcare Utilization and Costs: An Economic Analysis From the FIRE AND ICE Trial.

BACKGROUND: This study sought to assess payer costs following cryoballoon or radiofrequency current (RFC) catheter ablation of paroxysmal atrial fibrillation in the randomized FIRE AND ICE trial. METHODS AND RESULTS: A trial period analysis of healthcare costs evaluated the impact of ablation modality (cryoballoon versus RFC) on differences in resource use and associated payer costs. Analyses were based on repeat interventions, rehospitalizations, and cardioversions during the trial, with unit costs based on 3 national healthcare systems (Germany [€], the United Kingdom [£], and the United States [$]). Total payer costs were calculated by applying standard unit costs to hospital stays, using International Classification of Diseases, 10th Revision diagnoses and procedure codes that were mapped to country-specific diagnosis-related groups. Patients (N=750) randomized 1:1 to cryoballoon (n=374) or RFC (n=376) ablation were followed for a mean of 1.5 years. Resource use was lower in the cryoballoon than the RFC group (205 hospitalizations and/or interventions in 122 patients versus 268 events in 154 patients). The cost differences per patient in mean total payer costs during follow-up were €640, £364, and $925 in favor of cryoballoon ablation (P=0.012, 0.013, and 0.016, respectively). This resulted in trial period total cost savings of €245 000, £140 000, and $355 000. CONCLUSIONS: When compared with RFC ablation, cryoballoon ablation was associated with a reduction in resource use and payer costs. In all 3 national healthcare systems analyzed, this reduction resulted in substantial trial period cost savings, primarily attributable to fewer repeat ablations and a reduction in cardiovascular rehospitalizations with cryoballoon ablation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Identifier: NCT01490814.

Safety, long-term outcomes and predictors of recurrence after first-line combined endoepicardial ventricular tachycardia substrate ablation in arrhythmogenic cardiomyopathy. Impact of arrhythmic substrate distribution pattern. A prospective multicentre study.

BACKGROUND: First-line endoepicardial ventricular tachycardia (VT) ablation has been proposed for patients with arrhythmogenic cardiomyopathy (AC). This study reports procedural safety, outcomes, and predictors of recurrence. METHODS AND RESULTS: Forty-one consecutive patients [12 with left ventricle (LV) involvement, 7 left-dominant] underwent first-line endoepicardial VT substrate ablation. Standard bipolar and unipolar thresholds were used to define low-voltage areas (LVA). Arrhythmogenic substrate area (ASA) was defined as the area containing electrograms with delayed components. Implantable cardioverter defibrillator interrogations were evaluated for VT recurrence. Epicardial LVA was larger in all cases (102.5 ± 78.6 vs. 19.3 ± 24.4 cm2; P< 0.001). Consistent with an epicardium-to-endocardium arrhythmogenic substrate progression pattern, epicardial ASA (epi-ASA) was negatively correlated with bipolar endocardial LVA (r = -0.368; P= 0.035) and with endocardial bipolar/unipolar-LVA (Bi/Uni-LVA) ratio (r= -0.38; P= 0.037). A Bi/Uni-LVA ratio >0.23 predicted an epi-ASA ≤10 cm2 (100% sensitivity, 84% specificity). Patients showing an epi-ASA < 10 cm2 required less epicardial (8.4 ± 5.8 vs. 25.3 ± 16; P= 0.045) and more endocardial (16.5 ± 8.6 vs. 7.5 ± 8.2; P= 0.047) radiofrequency applications. One patient with epi-ASA < 10 cm2 died of cardiac tamponade after epicardial puncture. Acute success (no VT inducibility after procedure) was achieved in 36 patients (90%). After 32.2 ± 21.8 months, 11 (26.8%) patients had VT recurrences. Left-dominant AC was associated with an increased risk of recurrence (HR = 3.41 [1.1-11.2], P= 0.044; log-rank P= 0.021). CONCLUSION: First-line endoepicardial VT substrate ablation achieves good long-term results in AC. Left-dominant AC is associated with an increased risk of recurrence. The Bi/Uni-LVA ratio identifies patients with limited epicardial arrhythmogenic substrate in whom the indication of epicardial approach should be more cautiously assessed.

Contemporary management of patients undergoing atrial fibrillation ablation: in-hospital and 1-year follow-up findings from the ESC-EHRA atrial fibrillation ablation long-term registry.

AIMS: The ESC-EHRA Atrial Fibrillation Ablation Long-Term registry is a prospective, multinational study that aims at providing an accurate picture of contemporary real-world ablation for atrial fibrillation (AFib) and its outcome. METHODS AND RESULTS: A total of 104 centres in 27 European countries participated and were asked to enrol 20-50 consecutive patients scheduled for first and re-do AFib ablation. Pre-procedural, procedural and 1-year follow-up data were captured on a web-based electronic case record form. Overall, 3630 patients were included, of which 3593 underwent an AFib ablation (98.9%). Median age was 59 years and 32.4% patients had lone atrial fibrillation. Pulmonary vein isolation was attempted in 98.8% of patients and achieved in 95-97%. AFib-related symptoms were present in 97%. In-hospital complications occurred in 7.8% and one patient died due to an atrioesophageal fistula. One-year follow-up was performed in 3180 (88.6%) at a median of 12.4 months (11.9-13.4) after ablation: 52.8% by clinical visit, 44.2% by telephone contact and 3.0% by contact with the general practitioner. At 12-months, the success rate with or without antiarrhythmic drugs (AADs) was 73.6%. A significant portion (46%) was still on AADs. Late complications included 14 additional deaths (4 cardiac, 4 vascular, 6 other causes) and 333 (10.7%) other complications. CONCLUSION: AFib ablation in clinical practice is mostly performed in symptomatic, relatively young and otherwise healthy patients. Overall success rate is satisfactory, but complication rate remains considerable and a significant portion of patients remain on AADs. Monitoring after ablation shows wide variations. Antithrombotic treatment after ablation shows insufficient guideline-adherence.

Spanish Implantable Cardioverter-defibrillator Registry. Twelfth Official Report of the Spanish Society of Cardiology Electrophysiology and Arrhythmias Section (2015).

INTRODUCTION AND OBJECTIVES: We present the results of the Spanish Implantable Cardioverter-defibrillator Registry for 2015, as compiled by the Electrophysiology and Arrhythmia Section of the Spanish Society of Cardiology. METHODS: Data collection sheets were voluntarily completed by each implantation team and prospectively sent to the Spanish Society of Cardiology. RESULTS: The number of reported implantations was 5465 (85% of the estimated total number of implantations). The implantation rate was 118 per million population while the estimated rate was 138. First implantations comprised 71.8%. Data were obtained from 169 hospitals (7 more than in 2014). Most implantations (82.7%) were performed in men. The mean patient age was 62.8±13.3 years. Most patients showed severe or moderate-to-severe ventricular dysfunction and were in New York Heart Association function class II. The most frequent cardiac condition was ischemic heart disease, followed by dilated cardiomyopathy. Implantations for primary prevention indications comprised 58.2%. Electrophysiologists performed 79.6% of the implantations. CONCLUSIONS: The 2015 Spanish Implantable Cardioverter-defibrillator Registry received information on 85% of the implantations performed in Spain. The number of implantations has grown from previous years. The percentage of implantations for primary prevention indications has slightly decreased from the previous registry.

[Autologous mesenchymal stem cells and cutaneus autograft as a treatment for chronic ulcer secondary to diabetes mellitus 2]. / Células troncales mesenquimales autólogas e injerto cutáneo autólogo para tratamiento de una úlcera crónica secundaria a diabetes mellitus tipo2.

BACKGROUND: Diabetes mellitus 2 has become a global problem. It is estimated that 15% to 25% of patients could develop a chronic ulcer in their life, and nearly 33% of direct care costs of the diabetes mellitus 2 is spent on treating these ulcers. Mesenchymal stem cells have emerged as a promising cell source for the treatment of these ulcers. CLINICAL CASE: The case is presented of a 67 year-old male with a history of diabetes mellitus, acute myocardial infarction, and food ulcer chronic involving right foot and part of his leg. He was treated with mesenchymal stem cell management, resulting in skin graft integration and full coverage of the lesion. CONCLUSION: The implementation of mesenchymal stem cell techniques for treatment of chronic ulcer is feasible. The impact on the population would lead to a significant improvement in their quality of life and reduce healthcare spending.

Inhibition of the Na+/H+ antiporter induces cell death in TF-1 erythroleukemia cells stimulated by the stem cell factor.

Leukemia cells produce acidic metabolites due to their high metabolic condition. An alkaline pHi (intracellular pH) shift, caused by activation of the Na+/H+ exchange, is an important event in the mechanism of growth factor activity. However, the role of the Na(+)/H(+) exchanger in the survival of erythroleukemia TF-1 cells has not yet been studied in detail. The aim of this study was to identify the effects of 5-(N-ethyl-N-isopropyl) amiloride (EIPA), a highly specific blocker of the Na(+)/H(+) exchanger, on the survival of SCF-dependent TF-1 cells. The effects of EIPA on survival and mitochondrial membrane potential were studied when exposing wild type TF-1 cells and TF-1 cells expressing bcl-2 to EIPA for 48h. Ectopic expression of the bcl-2 gene maintained a mildly alkaline pH and prevented the simultaneous appearance of apoptosis and autophagy (typically displayed by TF-1 cells) in the presence of EIPA. Consistent with Stem Cell Factor (SCF) function, we found that this molecule rescued TF-1 cells during autophagy but not apoptosis, allowing these cells to subsequently respond to GM-CSF. Serum deprivation or SCF withdrawal induced cell death at 36h in TF-1 and TF-1 neo cells, whereas TF-1/bcl-2 cells tended to undergo apoptosis and show acidic vacuoles after 96h, pointing to a transient anti-apoptotic effect. The present study shows the suppressive effect of EIPA on the proliferation of leukemia cell line stimulated with SCF, apparently by decreasing the mitochondria membrane potential and averting alkalinization. Through the constitutive expression of bcl-2, TF-1 cells were survival factor independent. Proliferation in these cells was not affected by EIPA at the concentrations used against parental TF-1 cells, indicating that the inhibitory effect in SCF-stimulated cells can be attributed to specific blocking of the Na(+)/H(+) exchanger.

Serum levels of interleukin-2 predict the recurrence of atrial fibrillation after pulmonary vein ablation.

AIMS: Interleukin-2 has a significant antitumor activity in some types of cancer, and has been associated with the development of atrial fibrillation (AF). In addition, IL-2 serum levels in recent onset AF have been related with pharmaceutical cardioversion outcomes. We evaluated the hypothesis that a relationship exists between inflammation and the outcome of catheter ablation of AF. METHODS: We studied 44 patients with paroxysmal AF who underwent catheter ablation. Patients with structural heart disease, coronary artery or valve disease, active inflammatory disease, known or suspected neoplasm, endocrinopathies, or exposure to anti-inflammatory drugs were excluded. All study participants underwent evaluation with a standardized protocol, including echocardiography, and cytokine levels of interleukin-2, interleukin-4, interleukin-6, interleukin-10, tumour necrosis factor-alpha, and gamma-interferon determination before procedure. Clinical and electrocardiographic follow-up were performed with Holter-ECG at 3, 6 and 12months in order to know if sinus rhythm was maintained. RESULTS: After catheter ablation of the 44 patients included (53±10years, 27.3% female), all patients returned to sinus rhythm. During the first year of follow-up seven patients (15.9%) experienced recurrence of AF. The demographics, clinical and echocardiographic features, and pharmacological treatments of these patients were similar to those who maintained sinus rhythm. The only independent factor predictive of recurrence of AF was an elevated level of IL-2 (OR 1.18, 95% CI 1.12-1.38). CONCLUSIONS: High serum levels of interleukin-2, a pro-inflammatory non-vascular cytokine, are associated with the recurrence of AF in patients undergoing catheter ablation.

Quiste de conducto de Skene en niñas: A propósito de 2 casos clínicos / Skene duct cyst in female newborns: Case reports

Introduction: The Skene duct cyst, classified as a paraurethral cyst, is a rare congenital abnormality in female neonates and it may manifest throughout the course of life. The incidence varies from 1 in 2000 to 3000 female births. Objective: To expose the characteristics and symptoms of a Skene duct cyst at different stages of child development in order to carry out a timely suspicion and diagnosis. Case report: The first case is a female newborn who presented a painless yellowish tumor adjacent to the urethral meatus, which drained spontaneously; the second case is a teenager who consulted due to leucorrhea for a year and a three-centimeter diameter paraurethral injury between the labia minora, which required surgical treatment and study of the paraurethral mass. Conclusions: Based on the literature review, we concluded that the frequency of Skene duct cyst is higher than the number of reported cases. Cyst removal, marsupialization, puncture and aspiration are all effective treatment methods. Spontaneous drainage is also appropriate in certain cases. We suggest the use of the least aggressive technique according to each case.

Introducción: El quiste del conducto de Skene, se describe dentro de los quistes parauretrales, siendo una rara anomalía congénita descrita en neonatos de sexo femenino, que se puede presentar en el transcurso de la vida. La incidencia varía de 1 cada 2.000-3.000 recién nacidos vivos femeninos. Objetivo: Dar a conocer las características y formas de presentación del quiste del conducto de Skene en distintas etapas del desarrollo del niño para su sospecha y diagnóstico oportuno. Casos clínicos: Se presenta una recién nacida con una lesión tumoral amarillenta, adyacente al meato uretral, no dolorosa, que drena espontáneamente y un segundo caso de una adolescente que consulto por leucorrea de un año de evolución, con una lesión parauretral de tres centímetros de diámetro entre labios menores, que requirió tratamiento quirúrgico y estudio de la masa parauretral. Conclusiones: Basado en la revisión de la literatura, concluimos que la frecuencia de los quistes de conducto de Skene es más alta que el número de casos informados. La extirpación, marsupialización, la punción y aspiración del quiste son todos métodos eficaces de tratamiento. El drenaje espontáneo también es una conducta apropiada en ciertos casos. Se sugiere utilizar la técnica menos agresiva acorde a cada caso.

Experiencia en cirugía lumbar endoscópia / Experience in lumbar endoscopic surgery

La cirugía endoscópica de columna, resultado de la inquietud de múltiples investigadores en encontrar técnicas menos invasivas para el tratamiento de problemas quirúrgicos. Serie clínica de 33 pacientes, sometidos a cirugía lumbar endoscópica y evolución clínica (2009–2011). 33 pacientes, el 91% mínimo 6 meses de evolución, 100% fueron manejados ambulatorio, 52% femenino, 48% masculinos, promedio de 49 años de edad, 60% diagnostico de Lumbalgia discogenica y 40% síndrome de receso lateral y radiculalgia, 30% empleados públicos, 50% Discectomía endoscopia un nivel, 30% dos niveles, 17% tres niveles y 3% cuatro niveles, 21% tenía signos radiculares preoperatorios, un paciente (3%) espondilodiscitis, 37% reagudización clínica e inestabilidad lumbar, 15% requirió otra cirugía y 9% se le plantea nueva cirugía. Se evaluaron con la escala visual análoga del dolor, test de incapacidad de Oswestry, criterios de Macnab. La cirugía endoscópica lumbar, técnica atractiva, al reducir la vía de abordaje, reduce las complicaciones de cicatrización y la temprana incorporación a sus actividades. En nuestra experiencia, obtuvimos un 76% entre buenos y aceptables resultados y 24% malos según Macnab, lo que obliga a ser acuciosos para seleccionar al paciente.

Endoscopic surgery of the spine, resulting from the concern of many researchers to find less invasive techniques for the treatment of surgical problems. A case series of 33 patients who underwent lumbar endoscopic surgery and clinical course (2009 - 2011). 33 patients, 91% at least 6 months duration, 100% were ambulatory, 52% female, 48% male, average age 49 years, 60% diagnosis of discogenic low back pain and 40% lateral recess syndrome and radiculalgia, 30% civil servants, 50% endoscopic discectomy level, 30% two levels, three levels 17% and 3% four levels, 21% had preoperative radicular findings, one patient (3%) spondylodiscitis, 37% and clinical worsening lumbar instability, 15% required another surgery and 9% is facednew surgery. Were evaluated with visual analog pain scale, Oswestry Disability test, Macnab criteria. The lumbar endoscopic surgery, technically attractive, reducing the surgical approach, reduces the complications of early healing and incorporation into its activities. In our experience, we obtained 76% between good and acceptable and 24% poor results according to Macnab, making it necessary to be diligent to select the patient.

Spanish Implantable Cardioverter-Defibrillator Registry. Sixth official report of the Spanish Society Of Cardiology Working Group on Implantable Cardioverter-defibrillators (2009).

INTRODUCTION AND OBJECTIVES: This article describes the findings of the 2009 Spanish Implantable Cardioverter-Defibrillator (ICD) Registry compiled by the Working Group on Implantable Cardioverter-Defibrillators of the Spanish Society of Cardiology's Electrophysiology and Arrhythmias Section. METHODS: Each implantation team voluntarily sent prospective data recorded on a single-page document to the Spanish Society of Cardiology. RESULTS: In total, 4108 device implantations were reported, which comprised 88.6% of the estimated total number of implantations carried out. The number of implants reported corresponded to 89 per million population and the estimated total number was 100.2 per million. The proportion of first implantations among those reported was 71.3%. Data were received from 134 centers, 17 more than in 2008. There continued to be significant regional variations between the various Spanish autonomous regions. The highest implantation rate (81%) was in men (mean age 62 years) who had severe or moderate-to-severe ventricular dysfunction and were in New York Heart Association functional class II. The most common heart condition was ischemic heart disease, followed by dilated cardiomyopathy. Indications for primary prevention accounted for 55.9% of first implantations; this figure was lower than the previous year's for the first time since 2003. The most significant increase observed was in patients with ischemic heart disease. CONCLUSIONS: The 2009 Spanish ICD registry included data on almost 89% of all ICD implantations performed in the country. Although the number of implantations has continued to increase, it still remains far from the European average. The percentage of implantations performed for primary prevention was observed to have stabilized.

Persistence of secondary mitral regurgitation and response to cardiac resynchronization therapy.

AIMS: Cardiac resynchronization therapy (CRT) improves survival and quality of life in advanced heart failure (HF). Although mitral regurgitation (MR) reduction has been reported, its presence has been associated with non-response to CRT. This study was undertaken to assess the potential role of significant mitral regurgitation (SMR) persistence after CRT on clinical outcome, major arrhythmic events, and echocardiographic response in the mid-long term. METHODS AND RESULTS: Seventy-six patients (28.9% women, 63 +/- 11 years) with dilated cardiomyopathy in advanced HF were included. SMR, defined as regurgitant orifice area > or =0.20 cm(2), was assessed at baseline and its evolution 6 months after CRT. Clinical outcome (cardiovascular death/HF readmission), major arrhythmic events, and echocardiographic response (reverse remodelling) were recorded on follow-up. Thirty-two patients (42.1%) presented baseline SMR, becoming non-significant in 11 of the 32 patients (34.3%) 6 months after CRT. Its persistence was associated with higher rates of clinical events (46.4 vs. 18.7%, P = 0.011), arrhythmic events (35.7 vs. 14.5%, P = 0.034), and less reverse remodelling (28.5 vs. 83.3%, P < 0.001). CONCLUSION: CRT can reduce moderate or severe baseline MR to non-significant in one-third of patients. However, its persistence was associated with worse clinical evolution, greater incidence of arrhythmic events, and less reverse remodelling.

Combined resynchronization therapy and automatic defibrillator in advanced non-ischaemic heart failure: the importance of QRS width.

AIMS: The combined use of an automatic defibrillator in resynchronization therapy for primary prevention in patients with idiopathic dilated cardiomyopathy is controversial. METHODS AND RESULTS: We assessed a series of 46 patients (61 +/- 10 years, 64% male) with idiopathic dilated cardiomyopathy undergoing resynchronization therapy combined with a defibrillator in primary prevention and the potential relationship between baseline characteristics and the onset of ventricular arrhythmic events. Of the 46 patients included, eight (17%) presented episodes of ventricular tachycardia/fibrillation during follow-up (19 +/- 12 months). There were no baseline differences among these patients, except the proportion of males (57.9 vs. 100%, P = 0.02) and QRS width (162 +/- 24 vs. 189 +/- 26 ms, P = 0.008), which was the only independent predictor of arrhythmic events (OR 1.42, 95% CI 1.12-1.68; P = 0.03). CONCLUSION: In patients with idiopathic dilated cardiomyopathy undergoing resynchronization therapy combined with a defibrillator, baseline QRS is an independent predictor of arrhythmic events.

Morphology discrimination criterion wavelet improves rhythm discrimination in single-chamber implantable cardioverter-defibrillators: Spanish Register of morphology discrimination criterion wavelet (REMEDIO).

AIMS: Implantable cardioverter defibrillators (ICDs) are increasingly being used for treatment of ventricular tachycardia (VT)/fibrillation. Inappropriate therapy delivery remains the most frequent complication in patients with ICDs, resulting in psychological distress, proarrhythmia, and battery life reduction. We aim to determine if inappropriate therapies could be reduced by using a morphology discrimination criterion. METHODS AND RESULTS: We evaluated the performance of the Wavelet morphology discrimination algorithm (Medtronic, Inc.) independently from other discrimination enhancements (rate onset and interval stability). A non-randomized, prospective, multicenter, and observational study was designed to determine the sensitivity and specificity of the new morphology criterion. Sensitivity and specificity in slow tachycardia with cycle length (CL) between 340 and 500 ms were analysed as a pre-specified secondary endpoint. A total of 771 spontaneous episodes in 106 patients were analysed. Five hundred and twenty-two episodes corresponded to true supraventricular tachycardia (SVT) with ventricular CL in the VT or FVT zone, of which 473 had therapy appropriately withheld. Of the 249 episodes of true VT/FVT, 21 were classified according to the Wavelet criteria as SVT (specificity: 90.6%; sensitivity: 91.6%). All of them were spontaneously terminated with no adverse clinical consequences. No syncopal episodes occurred. For VTs in the slowest analysed range (CL: 340-500 ms), a total of 235 episodes were studied, yielding a specificity of 95.9% and sensitivity of 83.2%. CONCLUSION: Wavelet discrimination criteria in single-chamber ICDs as the sole discriminator can significantly reduce inappropriate therapy for SVT, not only in the range of VTs in the slowest analysed range (340-500 ms for this study) but also for faster VTs. No significant clinical consequences were found when the algorithm was used, but final data should prompt the use of the algorithm in combination with a high rate time-out feature.