Venous vascular closure system vs. figure-of-eight suture following atrial fibrillation ablation: the STYLE-AF Study.

AIMS: Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCSs) were introduced into clinical practice, aiming to reduce the time of bed rest, to increase the patients' comfort, and to reduce vascular access-related complications. The aim of the present study is to compare the safety and efficacy of using a VCS to achieve haemostasis following single-shot PVI to the actual standard of care [figure-of-eight suture and manual compression (MC)]. METHODS AND RESULTS: This is a prospective, multicentre, randomized, controlled, open-label trial performed at three German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation [109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; P < 0.001], shorter time to haemostasis [1 (1, 2) vs. 5 (2, 10) min; P < 0.001], and shorter time to discharge eligibility [270 (270, 270) vs. 340 (300, 458) min; P < 0.001]. No major vascular access-related complication was reported in either group. A trend towards a lower incidence of minor vascular access-related complications on the day of procedure was observed in the VCS group [7 (11.1%) vs. 15 (24.2%); P = 0.063] as compared to the control group. CONCLUSION: Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility. No major vascular access-related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access-related complications.

Pulsed Field Ablation-Based Pulmonary Vein Isolation Using a Simplified Single-Access Single-Catheter Approach　- The Fast and Furious PFA Study.

BACKGROUND: Pulsed field ablation (PFA) is a non-thermal energy source with promising safety and efficacy advantages. We aimed to develop a convenient, safe, effective and fast method of pulmonary vein isolation (PVI) utilizing a penta-spline PFA catheter via a single femoral vein and a venous closure system.Methods and Results: Consecutive patients (n=50; mean age: 63.6±10.7 years, 38% female) presenting with AF (paroxysmal AF: 56%) underwent first-time PVI via PFA. A single ultrasound-guided femoral vein puncture and a single transseptal puncture were used. After PVI using the penta-spline PFA catheter, extra pulse trains were added to the posterior wall for wide antral circumferential ablation. A venous closure system was used and a Donati suture was performed. The pressure bandage was removed after 1 h. A total of 196 PVs were identified and isolated with PFA only. The mean procedural time was 27.4±6.6 min, and the mean dwelling time was 14.4±5.5 min. Time to ambulation was 3.3±3.1 h. No severe complications occurred. During a mean follow-up of 6.5±2.1 months, 41/50 patients (82%) remained in sinus rhythm. CONCLUSIONS: The combination of a single venous puncture, single transseptal puncture approach using PFA and vascular closure device resulted in a 100% rate of acute PVI and an extraordinarily fast procedure and time to ambulation. The rate of periprocedural complications was low.

Tratamiento de COVID-19 en Panamá. La historia del inicio, estudio PanaCovid2020

Antecedentes En Panamá, durante los primeros cinco meses de pandemia, se reportaron 65,256 casos y 1,421 fallecimientos por COVID-19. Los tratamientos utilizados en pacientes hospitalizados durante este periodo fueron variando en la medida que surgía evidencia científica. Metodología Presentamos un estudio multicéntrico observacional, descriptivo, de corte transversal y retrospectivo de la terapéutica administrada en pacientes hospitalizados con COVID-19 en siete centros estatales de la República de Panamá, entre el 1 de marzo al 31 de julio de 2020. Se analizó el resultado de recuperado o fallecido en relación al uso de hidroxicloroquina, heparinas y esteroides. Resultados Se revisaron 837 expedientes. 60.7% pacientes eran hombres y la mediana de edad fue 53.6 años. Los tratamientos más utilizados fueron heparinas 84.7%, esteroides sistémicos 76.5%, azitromicina 65.5% e hidroxicloroquina en 41.1%. La frecuencia de uso de oxigenoterapia fue de cánula nasal 73,2%, máscara facial con reservorio 39%, cánula de alto flujo 8.9%, ventilación mecánica no invasiva 11.1% y ventilación invasiva en el 15.3%. Los esteroides mostraron mayor tasa de recuperación (OR 1.72 [1.16-2.54). Conclusiones El reto de abordar una nueva enfermedad, sin tratamiento conocido, con evolución y desenlace variable, llevó a la comunidad médica a utilizar medicamentos empíricos con potencial terapéutico incierto. Destacamos que desde muy temprano se administró esteroides sistémicos, heparinas y tocilizumab; actualmente con beneficios para pacientes con requerimientos de hospitalización. Además, se empleó técnicas de oxigenación, como la cánula de alto flujo y ventilación mecánica no invasiva, con dudosa efectividad; pero que hoy ya tienen un rol estudiado en la falla respiratoria por COVID-19. (provisto por Infomedic International)

Background: In Panama, during the first five months of the pandemic, 65,256 cases and 1,421 deaths due to COVID-19 were reported. The treatments used in hospitalized patients during this period varied as scientific evidence emerged. Methodology: We present a retrospective, descriptive, cross-sectional, observational, descriptive, multicenter study of the therapeutics administered in hospitalized patients with COVID-19 in seven state centers in the Republic of Panama, between March 1 and July 31, 2020. The outcome of recovered or deceased was analyzed in relation to the use of hydroxychloroquine, heparins and steroids. Results: A total of 837 files were reviewed. 60.7% of patients were men and the median age was 53.6 years. The most commonly used treatments were heparins 84.7%, systemic steroids 76.5%, azithromycin 65.5% and hydroxychloroquine in 41.1%. The frequency of oxygen therapy use was nasal cannula 73.2%, face mask with reservoir 39%, high-flow cannula 8.9%, noninvasive mechanical ventilation 11.1% and invasive ventilation in 15.3%. Steroids showed higher recovery rate (OR 1.72 [1.16-2.54). Conclusions: The challenge of dealing with a new disease, without known treatment, with variable evolution and outcome, led the medical community to use empirical drugs with uncertain therapeutic potential. We highlight the early administration of systemic steroids, heparins and tocilizumab; currently with benefits for patients requiring hospitalization. In addition, oxygenation techniques were used, such as high-flow cannula and noninvasive mechanical ventilation, with doubtful effectiveness, but which today have a studied role in respiratory failure due to COVID-19.   (provided by Infomedic International)

Very high-power short-duration temperature-controlled ablation versus conventional power-controlled ablation for pulmonary vein isolation: The fast and furious - AF study.

BACKGROUND: Catheter ablation for atrial fibrillation (AF) treatment provides effective and durable pulmonary vein isolation (PVI) and is associated with encouraging clinical outcome. A novel CF sensing temperature-controlled radiofrequency (RF) ablation catheter allows for very high-power short-duration (vHP-SD, 90 W/4 s) ablation aiming a potentially safer, more effective and faster ablation. We thought to evaluate preliminary safety and efficacy of vHP-SD ablation for PVI utilizing a novel vHP-SD catheter. The data was compared to conventional power-controlled ablation index (AI) guided PVI utilizing conventional contact force (CF) sensing catheters. METHODS AND RESULTS: Fifty-six patients with paroxysmal or persistent AF were prospectively enrolled in this study. Twenty-eight consecutive patients underwent vHP-SD based PVI (vHP-SD group) and were compared to 28 consecutive patients treated with conventional CF-sensing catheters utilizing the AI (control group). All PVs were successfully isolated using vHP-SD. The median RF ablation time for vHP-SD was 338 (IQR 286, 367) seconds vs control 1580 (IQR 1350, 1848) seconds (p < 0.0001), the median procedure duration was vHP-SD 55 (IQR 48-60) minutes vs. control 105 (IQR 92-120) minutes (p < 0.0001). No differences in periprocedural complications were observed. CONCLUSIONS: This preliminary data of the novel vHP-SD ablation mode provides safe and effective PVI. Procedure duration and RF ablation time were substantially shorter in the vHP-SD group in comparison to the control group.

Novel Cryoballoon Ablation System for Single Shot Pulmonary Vein Isolation　- The Prospective ICE-AGE-X Study.

BACKGROUND: The arctic front cryoballoon (AF-CB) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome. The POLARx cryoballoon incorporates unique features and design changes that may translate into improved efficacy, safety and further simplified balloon-based procedures. Efficacy and safety of the novel POLARx cryoballoon was compared to the fourth generation AF-CB (AF-CB4).Methods and Results:Twenty-five consecutive patients with paroxysmal or persistent atrial fibrillation were prospectively enrolled, underwent POLARx-based PVI (POLARx group) and were compared to 25 consecutive patients treated with the AF-CB4 (AF-CB4 group). All PVs were successfully isolated utilizing the POLARx and AF-CB4. A significant difference regarding the mean minimal cryoballoon temperatures reached using the AF-CB4 and POLARx (-50±6℃ vs. -57±7℃, P=0.004) was observed. Real-time PVI was visualized in 81% of POLARx patients and 42% of AF-CB4 patients (P<0.001). Utilizing the POLARx, a trend towards shorter median procedure time (POLARx: 45 [39, 53] min vs. AF-CB4: 55 [50, 60] min; P=0.062) was found. No differences were observed between AF-CB4 and POLARx concerning catheter maneuverability, catheter stability and periprocedural complications. CONCLUSIONS: The novel POLARx showed similar safety and efficacy compared to the AF-CB4. A higher rate of real-time PV recordings and significantly lower minimal balloon temperatures were observed using the POLARx.

Experience and procedural efficacy of pulmonary vein isolation using the fourth and second generation cryoballoon: The shorter, the better?

BACKGROUND: The second-generation cryoballoon (CB2) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome. The novel fourth-generation cryoballoon (CB4) incorporates a 40% shorter distal tip. This design change may translate into an increased rate of PVI real-time signal recording, facilitating an individualized ablation strategy using the time to effect (TTE). METHODS AND RESULTS: Three hundred consecutive patients with paroxysmal or persistent atrial fibrillation were prospectively enrolled. The first 150 consecutive patients underwent CB2 based PVI (CB2 group) and the last 150 consecutive patients were treated with the CB4 (CB4 group). A total of 594/594 (100%, CB4) and 589/594 (99.2%, CB2) pulmonary veins (PVs) were successfully isolated utilizing the CB4 and CB2, respectively (p = .283). The real-time PVI visualization rate was 47% (CB4) and 39% (CB2; p = .005) and the mean freeze cycle duration 200 ± 90 s (CB4) and 228 ± 110 s (CB2; p < .001), respectively. The total procedure time did not differ between the groups (CB4: 64 ± 32 min) and (CB2: 62 ± 29 min, p = .370). No differences in periprocedural complications were detected. CONCLUSIONS: A higher rate of real-time electrical PV recordings are seen using the CB4 as compared to CB2, which may facilitate an individualized ablation strategy using the TTE.

Propuestas metodológicas de trabajos de curso para la disciplina farmacología / Methodological proposals of final papers in the pharmacology discipline

Con el objetivo de evaluar las propuestas metodológicas diseñadas para los trabajos de curso de esta disciplina Farmacología en la Universidad de Ciencias Médicas de Santiago de Cuba durante el curso académico 2013-2014 se desarrolló el presente trabajo en tres etapas: diseño de las propuestas, implementación y evaluación de la satisfacción y resultados de estas. Las propuestas quedaron conformadas por tres ejercicios prácticos, dos para la asignatura Farmacología I y uno para Farmacología II. Estudiantes y profesores refirieron que los trabajos permitieron llevar a la práctica e integrar los conocimientos de la asignatura así como adquirir conocimientos sobre metodología de la investigación. Se consideraron los resultados de las evaluaciones a través informes semestrales de las asignaturas, se evidenció predominio de estudiantes con calificaciones entre 4 y 5. Se concluye que las propuestas diseñadas son satisfactorias para estudiantes y profesores, y las calificaciones avalan la calidad de los trabajos realizados(AU)

With the objective of evaluating the methodological proposals designed for the final papers of pharmacology discipline in the University of Medical Sciences of Santiago de Cuba in the 2013-2014 academic year, the present paper was made in three phases: design of proposals, implementation and evaluation of results of and satisfaction with such proposals. These proposals were finally shaped into three practical exercises; two for the pharmacology I subject and one for the pharmacology II subject. Both students and professors state that these final papers allowed putting into practice and integrating the knowledge of the subject as well as acquiring more knowledge about the research methodology. The results of evaluations included in the six-monthly reports of the subjects were taken into consideration in which most of students got grades of 4 and 5. It was concluded that the designed proposals are satisfactory for students and professors whereas the qualifications endorse the quality of the submitted final papers(AU)

Propuestas metodológicas de trabajos de curso para la disciplina farmacología / Methodological proposals of final papers in the pharmacology discipline

Con el objetivo de evaluar las propuestas metodológicas diseñadas para los trabajos de curso de esta disciplina Farmacología en la Universidad de Ciencias Médicas de Santiago de Cuba durante el curso académico 2013-2014 se desarrolló el presente trabajo en tres etapas: diseño de las propuestas, implementación y evaluación de la satisfacción y resultados de estas. Las propuestas quedaron conformadas por tres ejercicios prácticos, dos para la asignatura Farmacología I y uno para Farmacología II. Estudiantes y profesores refirieron que los trabajos permitieron llevar a la práctica e integrar los conocimientos de la asignatura así como adquirir conocimientos sobre metodología de la investigación. Se consideraron los resultados de las evaluaciones a través informes semestrales de las asignaturas, se evidenció predominio de estudiantes con calificaciones entre 4 y 5. Se concluye que las propuestas diseñadas son satisfactorias para estudiantes y profesores, y las calificaciones avalan la calidad de los trabajos realizados.

With the objective of evaluating the methodological proposals designed for the final papers of pharmacology discipline in the University of Medical Sciences of Santiago de Cuba in the 2013-2014 academic year, the present paper was made in three phases: design of proposals, implementation and evaluation of results of and satisfaction with such proposals. These proposals were finally shaped into three practical exercises; two for the pharmacology I subject and one for the pharmacology II subject. Both students and professors state that these final papers allowed putting into practice and integrating the knowledge of the subject as well as acquiring more knowledge about the research methodology. The results of evaluations included in the six-monthly reports of the subjects were taken into consideration in which most of students got grades of 4 and 5. It was concluded that the designed proposals are satisfactory for students and professors whereas the qualifications endorse the quality of the submitted final papers.

Total laparoscopic hysterectomy versus total abdominal hysterectomy: cohort review of patients with uterine neoplasia.

OBJECTIVE: Retrospective analysis of surgico-pathologic data comparing total laparoscopic hysterectomy (TLH) with total abdominal hysterectomy (TAH) patients with uterine neoplasia. METHODS: We conducted a chart abstraction of all patients undergoing hysterectomy for uterine neoplasia from September 1996 to November 2004. Patients were assigned to undergo the abdominal or laparoscopic approach based on established clinical safety criteria. RESULTS: The study included 105 patients, 29 with TAH and 76 with TLH. TAH patients were older (68 vs. 61, P=0.021); however, both groups had similar body mass indexes (31) and parities (1.6). Controlling for age, surgical duration was similar (152 minutes). Average blood loss was higher for TAH, (504 vs. 138 mL, P<0.001). Hospital stays were significantly longer for patients with TAH than for those with TLH (5.4 vs. 1.8 days, P<0.0001). Uterine weight was greater (197 vs. 135 g, P=0.008) and myometrial invasion deeper in the TAH group (48% outer half vs. 17%, P=0.001). More patients had Stage II or higher disease in the TAH group (35% vs. 17%, P=0.038). More TAH patients needed node dissection (79% vs. 28%, P<.001). Node yields from dissections of 23 TAH cases and 21 laparoscopic cases were similar (17 nodes). Total and reoperative complications from TAH versus TLH were not statistically different in our small sample (14.3 vs. 5.2% total, NS; 10.3 vs. 2.6% reoperative). One conversion was necessary from laparoscopy to laparotomy for unsuspected bulky metastatic disease. CONCLUSION: Based on clinical selection criteria, TLH performed for endometrial pathology has few complications and is well tolerated by select patients. The advantages are less blood loss and a shorter length of hospital stay for qualified patients.

Total laparoscopic hysterectomy for oncological indications with outcomes stratified by age.

OBJECTIVE: We hypothesize that there is no difference in surgical outcomes of patients undergoing total laparoscopic hysterectomy (TLH) for various oncological indications when stratified by age categories. METHODS: Data were analyzed by ANOVA and chi-square test with significance of P < 0.05, stratified by age (young: <50 years, middle: 50-64, senior age 65+). RESULTS: There were 208 patients, age 26-86 years: 85 young, 82 middle, and 41 senior women. Preoperative diagnoses included 13 cases of cervical dysplasia, 10 cervical or upper vaginal carcinoma, 60 endometrial neoplasias, 22 prophylaxes of familial ovarian carcinoma, 95 with complex pelvic mass, and 8 with early ovarian carcinoma. Mean body mass index (BMI) was 27.2 kg/m(2) for all groups. Parity increased with age (1.0, 1.3, and 2.0; P = 0.001). Surgical duration was longer for young than middle or senior (168, 147, and 140 min, P = 0.0095). All groups had a similar mean blood loss (133 cc, ns) and similar mean length of hospital stay (1.8 days, ns). Overall complication rate was 7.7% with no variance by age: one seroma, one hematoma, one diverticulitis, one incisional hernia, one vaginal nonhealing, one adhesive bowel obstruction, and five urologic complications (two bladder, three ureteral; four treated with catheter or stent, one reimplant. Reoperation was required in 2.8%. CONCLUSIONS: Null hypothesis accepted: TLH appears feasible and safe for oncological practice indications throughout the life span. This pilot data can facilitate guidelines for a randomized controlled trial of TLH with TAH and laparoscopic assisted vaginal hysterectomy (LAVH).

Selective incorporation of total laparoscopic hysterectomy for adnexal pathology and body mass index.

OBJECTIVES: We studied patients undergoing adnexectomy with total laparoscopic hysterectomy (TLH) for ovarian pathology, over a 6-year period. METHODS: Chart abstraction, analyzed by ANOVA, Fisher's Exact Test with significance at P < 0.05, stratifying by body mass index (BMI, kg/m(2): ideal < 25; overweight 25-29.9; obese 30+). RESULTS: Of 354 patients undergoing TLH, 90 cases had adnexal pathology: 69 complex masses, 16 BRCA1/2 mutations, 5 unstaged ovarian carcinomas; 48 having ideal BMI, 26 overweight, and 16 obese. Mean age (51 years) and parity (1.2 children) were similar between BMI groups. Thirty-four percent were nulliparous. All 90 underwent TLH, adnexectomy, washings; with 14 appendectomies, 5 lymphadenectomies, 3 node samplings, 6 omentectomies, 8 ureterolyses, and 1 Burch. Mean surgery duration (156 min), blood loss (152cc), and hospital stay (1.9 days) were similar across BMI groups. Mean nodal yield from each lymphadenectomy was 14, and 2.6 from sampling. Mean size of pelvic masses was 8 cm (range 3-19 cm). There were seven cases of ovarian carcinoma: 2 Stage IA, 1 IB, 2 IC, 1 IIC, 1 IIIB; 1 recurrent breast cancer, 16 adenofibromas, 15 endometriomas, 10 dermoids, and 41 serous/mucinous cystadenomas. Mean complication rate was 6.6% (ns): 1 seroma, 1 hematoma, 1 obstructive adhesions, and 3 urological injuries. All urological injuries were within the first third of patients. CONCLUSIONS: TLH appears feasible for women with adnexal pathology regardless of BMI, in an oncological practice. This pilot data can facilitate guidelines for a randomized controlled trial of TLH with TAH and LAVH, and help surgeons avoid our early complications.

Cáncer de mama localmente avanzado: evaluación del tratamiento con quimioterapia neoadyuvante (1997-2003) / Locally advanced breast cancer: evaluation of primary chemotherapy treatment (1997-2003)

En este trabajo se recopiló la información y evaluó la eficacia de la quimioterapia neoadyuvante en cáncer de mama con esquemas utilizados en los últimos seis años en nuestro Departamento. Se seleccionaron 21 pacientes con cáncer de mama localmente avanzado que recibieron quimiterapia neoadyuvante entre 1997-2003 con: FAC, CMF, AC, AT. En 21 pacientes evaluadas la edad promedio fue 53 años, 20 pacientes eran femeninos (90,4 por ciento) 1 paciente masculino (9,5 por ciento). 2 pacientes tenían estadio II-B (9,5 por ciento), 10 estadio III-A (47,6 por ciento, 9 pacientes estadio III-B (42,8 por ciento). 8 pacientes recibieron esquema de FAC (38,0 por ciento), 7 AC (33,3 por ciento), 4 esquema AT(19,0 por ciento) y 2 pacientes recibieron CMF (9,5 por ciento). Sólo 2 pacientes tuvieron respuesta completa (9,5 por ciento), 10 respuesta parcial (47,6 por ciento), 7 pacientes estabilización de la enfermedad (33,3 por ciento) y en 2 pacientes progresión de enfermedad (9,5 por ciento). A 17 pacientes se les pudo realizar mastectomía radical, en 1 paciente tratamiento preservador y 3 pacientes no se operaron (1 se negó a la cirugía y en 2 por progresión de la enfermedad). Recibieron radioterapia posoperatoria 18 pacientes (85,71 por ciento) 3 no recibieron radioterapia (14,28 por ciento). La quimioterapia neoadyuvante provee una valoración del efecto antitumoral in vivo, mejora la estadificación descendiente del tumor (de inoperable y de radical a conservadora), además nos da una oportunidad para evaluar objetivos biológicos sustitutivos

Total laparoscopic hysterectomy: body mass index and outcomes.

OBJECTIVE: This retrospective review of patients undergoing total laparoscopic hysterectomy examines whether differences in outcomes exist on the basis of body mass index (BMI). METHODS: All cases of total laparoscopic hysterectomy performed from September 1996 to July 2002 for benign diagnoses, and microinvasive cervical, early endometrial, and occult ovarian carcinoma were reviewed. There were 330 patients analyzed by BMI category (range, 18.5-54.1): ideal (n = 150) less than 24.9 kg/m(2), overweight (n = 95) 25 to 29.9 kg/m(2), and obese (n = 78) 30 kg/m(2) or more. Seven patients were converted to laparotomy (four ideal BMI, two overweight, one obese) leaving 323 (98%) for analysis. Mean age (50 years), height (65 in.), and parity (1.2) were similar, with 39% nulligravidas in each group. RESULTS: Mean operating time (156 minutes), blood loss (160 mL), and length of hospital stay (1.9 days) did not vary by BMI group. Total complication rates (8.9%), and major (5.5%) and minor (3.4%) complication rates were similar in each BMI group. Urologic injury was observed in 3.1%, with two-thirds occurring in the first one-third of the patient series. CONCLUSION: Total laparoscopic hysterectomy is feasible and safe, resulting in short hospital stay, minimal blood loss, and minimal operating time for patients in all BMI groups. The laparoscopic approach may extend the benefits of minimally invasive hysterectomy to the very obese, for whom abdominal surgery poses serious risk.

Piomiositis causada por serratia marcescens en un pacientes neutropénico febril / Piomysitis originator for serratia marcescens in one patients neutropenic febrile

Se describe el caso de una paciente con diagnóstico de leucemia mieloide aguda (MO-Ml) y neutropénica febril con piomiositis en ambos en quien se identificó una bacteria (Serratia marcescens) en el material purulento obtenido de la aspiración de los abscesos. Se evalúa la respuesta al tratamiento instaurado y se recomienda considerar a este germen como agente causal de piomiositis en pacientes neutropénicos febriles