Efficacy and Safety of an Extravascular Implantable Cardioverter-Defibrillator.

BACKGROUND: The extravascular implantable cardioverter-defibrillator (ICD) has a single lead implanted substernally to enable pause-prevention pacing, antitachycardia pacing, and defibrillation energy similar to that of transvenous ICDs. The safety and efficacy of extravascular ICDs are not yet known. METHODS: We conducted a prospective, single-group, nonrandomized, premarket global clinical study involving patients with a class I or IIa indication for an ICD, all of whom received an extravascular ICD system. The primary efficacy end point was successful defibrillation at implantation. The efficacy objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients with successful defibrillation was greater than 88%. The primary safety end point was freedom from major system- or procedure-related complications at 6 months. The safety objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients free from such complications was greater than 79%. RESULTS: A total of 356 patients were enrolled, 316 of whom had an implantation attempt. Among the 302 patients in whom ventricular arrhythmia could be induced and who completed the defibrillation testing protocol, the percentage of patients with successful defibrillation was 98.7% (lower boundary of the one-sided 97.5% confidence interval [CI], 96.6%; P<0.001 for the comparison with the performance goal of 88%); 299 of 316 patients (94.6%) were discharged with a working ICD system. The Kaplan-Meier estimate of the percentage of patients free from major system- or procedure-related complications at 6 months was 92.6% (lower boundary of the one-sided 97.5% CI, 89.0%; P<0.001 for the comparison with the performance goal of 79%). No major intraprocedural complications were reported. At 6 months, 25 major complications were observed, in 23 of 316 patients (7.3%). The success rate of antitachycardia pacing, as assessed with generalized estimating equations, was 50.8% (95% CI, 23.3 to 77.8). A total of 29 patients received 118 inappropriate shocks for 81 arrhythmic episodes. Eight systems were explanted without extravascular ICD replacement over the 10.6-month mean follow-up period. CONCLUSIONS: In this prospective global study, we found that extravascular ICDs were implanted safely and were able to detect and terminate induced ventricular arrhythmias at the time of implantation. (Funded by Medtronic; ClinicalTrials.gov number, NCT04060680.).

Endothelial vascular markers in coronary surgery.

Coronary heart disease is associated with high morbidity and mortality. Endothelial dysfunction in affected patients is linked to long-term atherosclerotic disease progression and cardiovascular event rates. The present paper reports on changes in the levels of endothelial progenitor cells (VEGFR2/CD133/CD34), essential for endothelial repair, and of endothelial microvesicles (CD31/annexin V) as indicators of endothelial lesion, in patients undergoing coronary bypass surgery with respect both to baseline levels and to counts in healthy subjects. In an observational descriptive study, 31 patients scheduled for coronary revascularization surgery were compared with those of 25 healthy controls. In a subsequent longitudinal study, patients undergoing surgery were monitored at 5 timepoints up until 48 h after surgery. Endothelial progenitor cell (VEGFR2/CD133/CD34) and endothelial microvesicle (CD31/annexin V) levels were quantified by flow cytometry. Baseline endothelial progenitor cell counts in coronary patients were significantly lower than those of healthy controls (p < 0.001); however, after surgery, levels rose steadily over all 5 timepoints to 48 h  with statistically significant differences (p < 0.001) between intra-operative and 48 h after surgery (T5). Endothelial microvesicle levels were significantly higher in coronary patients prior to surgery than in healthy controls (p < 0.001), and despite declining at 48 h remained significantly higher than those of controls (p < 0.001). Coronary surgery has had a positive impact on the endothelium in the patients, prompting a decrease in signs of endothelial dysfunction and a considerable improvement in the endothelial repair mechanisms involved in angiogenesis, playing an important role in the inflammatory response and the remodelling process of ischemic myocardium in postoperative period.

Biological or mechanical prostheses for isolated aortic valve replacement in patients aged 50-65 years: the ANDALVALVE study.

OBJECTIVES: The decision about whether to use a biological or a mechanical prosthesis for aortic valve replacement remains controversial in patients between 50 and 65 years of age and has yet to be addressed in a Mediterranean population. This research aimed to analyse long-term survival and major morbidity rates (30-day mortality, stroke, any prosthetic reoperation and major bleeding) within this population. METHODS: Our multicentre observational retrospective study included all subjects aged 50-65 years who had a primary isolated aortic valve replacement due to severe aortic stenosis at 7 public hospitals from Andalusia (Spain) between 2000 and 2015. Concomitant surgery, reoperations and endocarditis were the exclusion criteria. A total of 1443 patients were enrolled in the study (272 with biological and 1171 with mechanical valves). Multivariate analyses including a 2:1 propensity score matching (506 mechanical and 257 biological prostheses) were conducted. RESULTS: Bioprostheses were implanted in 18.8% (n = 272): 35% were women; the mean EuroSCORE-I was 3%. The mean follow-up was 8.1 ± 4.9 years in a matched sample: 8.8 ± 4.9 years in those receiving a mechanical vs 7.1 ± 4.5 years in those receiving a biological prosthesis (P = 0.001). In the paired sample, the 15-year survival rate was 73% in those who had a biological vs 76% in those who had a mechanical valve [hazard ratio (HR) 0.80, 95% confidence interval (CI) 0.54-1.20; P = 0.159]. No significant differences were observed in patients ≥55 years old (74% of 15-year survival in both groups: HR 0.88, 95% CI 0.56-1.34; P = 0.527). A higher rate of major bleeding was found in patients with a mechanical prosthesis (P = 0.004), whereas reoperation was more frequent among those with a biological prosthesis (P = 0.01). CONCLUSIONS: Long-term survival was comparable in patients above 55 years of age. Mechanical prostheses were associated with more major bleeding and bioprostheses, with more reoperations. A bioprosthesis in patients above 55 years old is a reasonable choice. CLINICAL TRIAL REGISTRATION NUMBER: NCT03239509.

[Incidence and clinical impact of pulmonary homograft dysfunction after the Ross procedure]. / Incidencia e impacto clínico de la estenosis del homoinjerto pulmonar tras el procedimiento de Ross.

INTRODUCTION AND OBJECTIVES: We analyzed the incidence, risk factors and clinical impact of pulmonary homograft dysfunction after the Ross procedure in our patients. PATIENTS AND METHOD: All patients were evaluated at 3, 6 and 12 months, and annually thereafter. Patients with a transhomograft pressure gradient greater than 30 mmHg were referred for cardiac magnetic resonance imaging. RESULTS: At the end of the study, 9 patients (11.8%) showed a transhomograft pressure gradient >30 mmHg after a mean period of 15.3 months post-surgery. Mean transhomograft pressure gradient was 19.8 (16.2%) (range, 2-100 mmHg). All patients were in functional class I, except 2 who were in New York Heart Association class II with severe stenosis. These 2 patients were treated percutaneously with stent placement and no reoperation. No association was found between clinical outcome and sex, age or homograft diameter. We found a trend toward greater perioperative use of plasma, platelets and red cells in the group of patients in comparison to controls, although the difference was significant only for postoperative use of plasma (1.7 [3] vs 5.5 [5.3] units; P<0.05). Cardiac magnetic resonance imaging showed stenosis predominantly in the body of the homograft, whereas the valvular component itself remained competent. Right ventricular hypertrophy was mild or very mild in 7 patients and moderate in 2. CONCLUSIONS: The incidence of some degree of pulmonary homograft dysfunction after the Ross procedure was non-negligible, but its clinical impact seems to be slight. Patients with severe stenosis were treated successfully via a percutaneous approach. The use of blood products might be a risk factor for the development of this complication.

Heart transplantation in a patient with recurrent early extensive endocarditis.

Active valvular endocarditis could be considered a contraindication to heart transplantation. Nevertheless, there have been some reports of success with this form of treatment, despite the characteristics of the infection and its aggressive nature. Here, we describe the case of a patient with acute bicuspid aortic valvular endocarditis caused by Staphylococcus aureus and with a periannular abscess. Cryopreserved aortic homograft replacement of the aortic root was initially carried out, in addition to debridement and reconstruction of the interventricular septum with a pericardial patch. Early recurrence occurred, however, with extensive tissue destruction, a periaortic abscess and involvement of multiple valves, associated with severe sepsis. In view of the failure of 'conventional' surgery, an emergency heart transplantation was decided on after discussing the case with the Spanish National Transplant Organization (ONT), because of the theoretical contraindication of transplantation in this case. Transplantation was finally carried out after a waiting period of 3 days, in emergency code conditions, and the postoperative course proved uneventful, with no reinfection during the follow-up period. The present case suggests that heart transplantation may be an alternative option in patients suffering aggressive endocarditis with extensive involvement of the heart structures.

Embolia en cavidades cardiacas derechas: Aspectos diagnósticos y terapéuticos / Right heart chambers embolism. Diagnostic and therapeutic aspects

La trombosis venosa profunda puede causar embolias pulmonares. En raras ocasiones, la embolización se produce, no directamente en el árbol arterial pulmonar, sino en las cavidades cardiacas derechas. Aunque el valor de la ecocardiografía en el diagnóstico es bien reconocido, actualmente no existe consenso en cuanto al tratamiento apropiado. Presentamos seis casos de trombo flotante en aurícula derecha, diagnosticado por ecocardiografía, en pacientes con embolias pulmonares o con shock o síncope sin causa evidente. Se realizó embolectomía quirúrgica en 4 pacientes, y tratamiento fibrinolítico en 2, sin mortalidad hospitalaria. La elevada mortalidad asociada con esta patología puede reducirse con un diagnóstico ecocardiográfico rápido y un tratamiento emergente con fibrinolisis o cirugía. Nuestros datos sugieren la posible utilización de la fibrinolisis como tratamiento de primera elección en casos seleccionados