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1.
Pacing Clin Electrophysiol ; 44(4): 651-656, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-33592679

RESUMEN

BACKGROUND: Pulmonary vein isolation (PVI) with autonomic modulation may be more successful than PVI alone for atrial fibrillation (AF) ablation and may be signaled by changes in sinus rhythm heart rate (HR) post ablation. We sought to determine if a change in sinus rhythm HR predicted AF recurrence post PVI. METHODS: Patients who underwent AF ablation from 2000 to 2011 were included if sinus rhythm was noted on ECG within 90 days pre and 7 days post ablation. Basic ECG interval and HR changes were analyzed and outcomes determined. RESULTS: A total of 1152 patients were identified (74.3% male, mean age 57 ± 11 years). Mean AF duration was 5.2 ± 5.3 years. Paroxysmal AF was noted in 712 (61.8%) of the patients. Mean EF was 61% ± 6%. Sinus rhythm HR was 61 ± 11 pre-ablation and 76 ± 13 bpm post-ablation (27% ± 24% increase, p < .001). The ability of relative HR change post-ablation to predict AF recurrence was borderline (hazard ratio 0.65 [0.41-1.01], p = .067). With patients separated into quartiles based on the relative HR change, the upper quartile with the largest relative increase in HR had a significantly lower rate of AF recurrence compared to the lowest quartile following multi variable modeling (p = .038). There were significant changes in PR (171 ± 28 to 167 ± 30 ms) and QTc (424 ± 25 to 434 ± 29 ms) intervals (both p < .001) but these were not predictive of outcome. CONCLUSION: Relative changes in HR post AF ablation correlates with AF recurrence. Further prospective studies are needed to confirm this relationship.


Asunto(s)
Fibrilación Atrial/cirugía , Ablación por Catéter , Frecuencia Cardíaca/fisiología , Venas Pulmonares/cirugía , Adulto , Fibrilación Atrial/fisiopatología , Niño , Femenino , Atrios Cardíacos/fisiopatología , Humanos , Lactante , Masculino , Persona de Mediana Edad , Recurrencia
2.
J Thromb Haemost ; 18(6): 1408-1414, 2020 06.
Artículo en Inglés | MEDLINE | ID: mdl-32180317

RESUMEN

BACKGROUND: Nonbacterial thrombotic endocarditis (NBTE) is a potential complication of antiphospholipid syndrome (APS) manifesting as noninfectious lesions on one or more cardiac valves. There are limited tools to inform clinicians regarding which APS patients would benefit most from echocardiographic screening for this complication. OBJECTIVES: We tested the hypothesis that the risk of both prevalent and incident NBTE is directly related to the number of positive laboratory assays for APS. PATIENTS/METHODS: In this single-center, retrospective, cohort study design, consecutive patients with confirmed APS seen at Mayo Clinic Rochester, MN (1/1/1993-6/26/2016), were identified by searching a centralized electronic database. Demographic data, clinical presentation, echocardiographic features, laboratory findings, and survival data were scrutinized. RESULTS: During the study period, 611 patients met the diagnostic criteria for APS and 386 (63%) underwent echocardiography. Of these, 58 (15%) were found to have NBTE. NBTE was more common in those with double (19.4%) and triple-positive laboratory criteria (27.0%) compared with single-positive disease (5.7%, P < .001). Survival free of NBTE diagnosis was significantly shorter in those patients with >1 positive laboratory assay (P < .01). Cox proportional hazard analysis suggests that patients with APS are more likely to be diagnosed with NBTE if they have >1 positive laboratory assay (relative risk 20.1; 95% confidence interval 1.3-316.6; P < .03). CONCLUSION: Antiphospholipid syndrome carries a high prevalence of NBTE (15%). This prevalence is particularly high for patients with either double- or triple-positive laboratory criteria.


Asunto(s)
Síndrome Antifosfolípido , Endocarditis no Infecciosa , Endocarditis , Síndrome Antifosfolípido/complicaciones , Síndrome Antifosfolípido/diagnóstico , Síndrome Antifosfolípido/epidemiología , Estudios de Cohortes , Endocarditis/diagnóstico , Endocarditis/epidemiología , Endocarditis no Infecciosa/diagnóstico por imagen , Endocarditis no Infecciosa/epidemiología , Humanos , Laboratorios , Prevalencia , Estudios Retrospectivos
3.
J Thromb Haemost ; 18(2): 411-421, 2020 02.
Artículo en Inglés | MEDLINE | ID: mdl-31630479

RESUMEN

BACKGROUND: Low-molecular-weight heparin is the guideline-endorsed treatment for cancer-associated venous thromboembolism (VTE). While apixaban is approved for the treatment of acute VTE, limited data support its use in cancer patients. OBJECTIVES: The primary outcome was major bleeding. Secondary outcomes included VTE recurrence and a composite of major plus clinically relevant non-major bleeding (CRNMB). PATIENTS/METHODS: Patients with cancer-associated VTE were randomly assigned to receive either apixaban 10 mg twice daily for seven days followed by 5 mg twice daily for six months or subcutaneous dalteparin (200 IU/kg for one month followed by 150 IU/kg once daily). RESULTS: Of 300 patients randomized, 287 were included in the primary analysis. Metastatic disease was present in 66% of subjects; 74% were receiving concurrent chemotherapy. Major bleeding occurred in 0% of 145 patients receiving apixaban, compared with 1.4% of 142 patients receiving dalteparin [P = .138; hazard ratio (HR) not estimable because of 0 bleeding event in apixaban group]. Recurrent VTE occurred in 0.7% of apixaban, compared to 6.3% of dalteparin patients [HR 0.099, 95% confidence interval [CI], 0.013-0.780, P = .0281). Major bleeding or CRNMB rates were 6% for both groups. CONCLUSIONS: Oral apixaban was associated with low major bleeding and VTE recurrence rates for the treatment of VTE in cancer patients.


Asunto(s)
Dalteparina , Tromboembolia Venosa , Anticoagulantes/efectos adversos , Dalteparina/efectos adversos , Humanos , Recurrencia Local de Neoplasia , Pirazoles , Piridonas , Resultado del Tratamiento , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/tratamiento farmacológico
4.
Eur J Haematol ; 104(2): 88-96, 2020 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-31606897

RESUMEN

BACKGROUND: Cancer-associated venous thromboembolism (VTE) carries a high rate of recurrence and death. Guidelines recommend continued anticoagulation therapy as long as active cancer persists. Apixaban 2.5 mg twice daily is the FDA-approved dose for secondary prevention regardless of VTE causation. Whether this apixaban dose is appropriate for secondary VTE prevention in cancer patients is not clear. The rationale and design of this investigator initiated phase III, multicenter, randomized, double-blind, trial assessing apixaban 2.5 mg vs 5 mg twice daily for 12 months for the secondary VTE prevention in cancer patients (n = 370) who have completed 6 months (but no more than 12 months) of anticoagulation is provided (NCT03080883). METHODS/DESIGN: The primary study objective is to estimate differences in the combined rate of major plus clinically relevant non-major bleeding for apixaban 2.5 mg vs 5 mg twice daily. Secondary efficacy outcome is to assess rates of venous or arterial thromboembolism. Participating centers are chosen from the Academic and Community Cancer Research United (ACCRU) consortium. CONCLUSION: We anticipate these trial results to provide evidence supporting low-dose apixaban as a safe agent for secondary prevention of cancer-associated VTE for patients who have already completed 6-12 months of anticoagulation.


Asunto(s)
Anticoagulantes/administración & dosificación , Neoplasias/tratamiento farmacológico , Pirazoles/administración & dosificación , Piridonas/administración & dosificación , Tromboembolia Venosa/prevención & control , Anticoagulantes/efectos adversos , Método Doble Ciego , Femenino , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/epidemiología , Pirazoles/efectos adversos , Piridonas/efectos adversos , Tromboembolia Venosa/epidemiología
5.
United European Gastroenterol J ; 7(4): 548-556, 2019 05.
Artículo en Inglés | MEDLINE | ID: mdl-31065372

RESUMEN

Background: Esophageal food impaction is relatively common and increasing over time. Treatment ranges from medications to invasive endoscopic therapies. The endoscopic push technique has been advised against in favor of endoscopic retrieval for safety concerns. We sought to assess use patterns and safety of treatments for food impaction in a population-based retrospective review. Methods: A database of recorded esophageal food impactions in Olmsted County, MN, USA, from 1975-2011 was reviewed for patient demographics, treatment, and complications. Results: A total of 645 impactions occurred, with increasing incidence over time, peaking at 23.2 per year (2000-2004). Medications (almost exclusively glucagon) were successful in relieving impactions 34.5% of the time when trialed. Urgent endoscopy was common (74.0%), as was the need for endoscopic therapy (67.1%). Endoscopic therapy increased over time, with the endoscopic push technique becoming most common. Esophageal complications (deep mucosal injury or perforation) increased over time but remained rare (peak 11%). There was no difference in complications between push and retrieval techniques. Conclusions: The endoscopic push technique is safe in comparison to endoscopic retrieval in esophageal food impactions. While complications surrounding impaction have increased, they remain rare. Medication trials are reasonable, as long as they do not delay endoscopy, and may prevent the need for emergent endoscopy in one-third of cases.


Asunto(s)
Trastornos de Deglución/terapia , Endoscopía del Sistema Digestivo/tendencias , Alimentos/efectos adversos , Cuerpos Extraños/terapia , Fármacos Gastrointestinales/administración & dosificación , Adulto , Anciano , Trastornos de Deglución/epidemiología , Trastornos de Deglución/etiología , Endoscopía del Sistema Digestivo/efectos adversos , Endoscopía del Sistema Digestivo/métodos , Esófago/diagnóstico por imagen , Esófago/efectos de los fármacos , Femenino , Cuerpos Extraños/epidemiología , Cuerpos Extraños/etiología , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento
6.
Indian Pacing Electrophysiol J ; 19(2): 40-46, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-30858056

RESUMEN

BACKGROUND: The prognostic significance of paced QRS complex morphology on surface ECG remains unclear. This study aimed to assess long-term outcomes associated with variations in the paced QRS complex. METHODS: Adult patients who underwent dual-chamber pacemaker implantation with 20% or more ventricular pacing and a 12-lead ECG showing a paced complex were included. The paced QRS was analyzed in leads I and aVL. Long-term clinical and echocardiographic outcomes were compared at 5 years. RESULTS: The study included 844 patients (43.1% female; age 75.0 ±â€¯12.1). Patients with a longer paced QRS (pQRS) duration in lead I had a lower rate of atrial fibrillation (HR 0.80; p = 0.03) and higher rate of systolic dysfunction (HR 1.17; p < 0.001). Total pacing complex (TPC) duration was linked to higher rates of ICD implantation (HR 1.18; p = 0.04) and systolic dysfunction (HR 1.22, p < 0.001). Longer paced intrinsicoid deflection (pID) was associated with less atrial fibrillation (HR 0.75; p = 0.01), more systolic dysfunction (HR 1.17; p < 0.001), ICD implantation (HR 1.23; p = 0.04), and CRT upgrade (HR 1.23; p = 0.03). Exceeding thresholds for TPC, pQRS, and pID of 170, 146, and 112 ms in lead I, respectively, was associated with a substantial increase in systolic dysfunction over 5 years (p < 0.001). CONCLUSIONS: Longer durations of all tested parameters in lead I were associated with increased rates of left ventricular systolic dysfunction. ICD implantation and CRT upgrade were also linked to increased TPC and pID durations. Paradoxically, patients with longer pID and pQRS had less incident atrial fibrillation.

7.
Mayo Clin Proc ; 94(7): 1242-1252, 2019 07.
Artículo en Inglés | MEDLINE | ID: mdl-30737059

RESUMEN

OBJECTIVE: To compare the clinical efficacy and safety of apixaban with those of rivaroxaban for the treatment of acute venous thromboembolism (VTE). PATIENTS AND METHODS: Consecutive patients enrolled in the Mayo Thrombophilia Clinic Registry (between March 1, 2013, and January 30, 2018) and treated with apixaban or rivaroxaban for acute VTE were followed forward in time. The primary efficacy outcome was VTE recurrence. The primary safety outcome was major bleeding; the second safety outcome was clinically relevant nonmajor bleeding (CRNMB); and the third was a composite of major bleeding or CRNMB. RESULTS: Within the group of 1696 patients with VTE enrolled, 600 (38%) were treated either with apixaban (n=302, 50%) or rivaroxaban (n=298, 50%) within the first 14 days of VTE diagnosis and who completed at least 3 months of therapy or had a study event. Recurrent VTE was diagnosed in 7 patients (2.3%) treated with apixaban and in 6 (2%) treated with rivaroxaban (adjusted hazard ratio [aHR], 1.4; 95% CI, 0.5-3.8). Major bleeding occurred in 11 patients (3.6%) receiving apixaban and in 9 patients (3.0%) receiving rivaroxaban (aHR, 1.2; 95% CI, 0.5-3.2). Clinically relevant nonmajor bleeding was diagnosed in 7 patients (2.3%) receiving apixaban and in 20 (6.7%) receiving rivaroxaban (aHR, 0.4; 95% CI, 0.2-0.9). The rates of composite major bleeding or CRNMB were similar (aHR, 0.6; 95% CI, 0.3-1.2). Most study events occurred in patients with cancer. CONCLUSION: In the setting of a standardized, guideline-directed, patient-oriented clinical practice, the efficacy and safety of apixaban and rivaroxaban for the treatment of acute VTE were comparable.


Asunto(s)
Inhibidores del Factor Xa/uso terapéutico , Pirazoles/uso terapéutico , Piridonas/uso terapéutico , Rivaroxabán/uso terapéutico , Tromboembolia Venosa/tratamiento farmacológico , Femenino , Hemorragia/inducido químicamente , Humanos , Masculino , Persona de Mediana Edad , Recurrencia , Resultado del Tratamiento
8.
Obstet Gynecol ; 131(4): 741-742, 2018 04.
Artículo en Inglés | MEDLINE | ID: mdl-29578970
9.
J Clin Gastroenterol ; 52(2): 131-136, 2018 02.
Artículo en Inglés | MEDLINE | ID: mdl-27824640

RESUMEN

GOAL: The purpose of this study was to characterize outcomes of esophagorespiratory fistulas (ERF) by etiology and initial treatment strategy. BACKGROUND: ERF is a morbid condition for which optimal treatment strategies and outcomes are still in evolution. STUDY: Medical records and images were reviewed for all patients diagnosed with ERF at Mayo Clinic in Rochester, MN, between September 1, 2001 and January 1, 2012. Fistulas were classified as malignant or benign. Treatment strategies were classified as surgical or nonsurgical (typically esophageal stent placement). Technical and clinical success, survival, and survival free of second intervention were assessed. RESULTS: A total of 123 patients with acquired ERF were identified, of whom 65 (53%) were malignant and 58 (47%) benign. Initial treatment strategy was nonsurgical in 88 (72%) patients and surgical in 35 (28%); lower Charlson comorbidity scores were associated with increased likelihood of surgery. Technical and clinical success was seen in a majority of patients treated both surgically and nonsurgically. Patients with malignant ERF treated surgically survived longer than patients undergoing nonsurgical treatment (hazard ratio=5.6, P=0.005). In contrast, those with benign ERF had similar overall survival regardless of whether they received initial surgical or nonsurgical treatment; reintervention was more common in those who underwent nonsurgical treatment (hazard ratio=2.3, P=0.03). CONCLUSIONS: We conclude that survival in malignant ERF is better with surgical intervention in selected patients. Surgical and nonsurgical techniques achieve similar survival in benign ERF, but reintervention is more common in those treated endoscopically.


Asunto(s)
Fístula Esofágica/terapia , Neoplasias Esofágicas/terapia , Fístula del Sistema Respiratorio/terapia , Neoplasias del Sistema Respiratorio/terapia , Anciano , Fístula Esofágica/patología , Neoplasias Esofágicas/patología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Fístula del Sistema Respiratorio/patología , Neoplasias del Sistema Respiratorio/patología , Estudios Retrospectivos , Stents , Sobrevida , Resultado del Tratamiento
10.
Eur J Haematol ; 100(1): 83-87, 2018 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-29131406

RESUMEN

PURPOSE: Testicular vein thrombosis (TVT) etiology, recurrence, and survival were compared with lower extremity deep vein thrombosis (DVT) in order to determine whether treatment guidelines for DVT could be applied to TVT. PATIENTS AND METHODS: An inception cohort of patients with confirmed TVT (January 1995-October 2015) was compared to a control group of patients with lower extremity DVT matched by age, gender, and diagnosis date. RESULTS: Thirty-nine men with TVT were identified; 15 (38%) with isolated TVT. Left testicular vein was affected in 77% patients; there were no cases of bilateral TVT. Cancer was over twofold more common in TVT patients (59% vs 28%, P = .01). Most cancers (78%) involved organs in proximity to the testicular vein. Although TVT patients were less frequently treated with anticoagulants (49% vs 97%, P = .0001), recurrence rates were similar to DVT group (TVT 4.2 vs DVT 1.1 per 100 patient-years, P = .11). Despite higher cancer prevalence, survival rates were similar between groups (31% vs 28%; P = .34). Major bleeding events were rare (one patient per group). CONCLUSIONS: Identifying TVT should prompt a search for a regional malignancy. Despite the high cancer prevalence and low utilization of anticoagulants, recurrent venous thrombosis and mortality rates are similar to DVT patients.


Asunto(s)
Enfermedades Testiculares/epidemiología , Tromboembolia Venosa/epidemiología , Adulto , Anciano , Comorbilidad , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Prevalencia , Recurrencia , Factores de Riesgo , Tasa de Supervivencia , Enfermedades Testiculares/diagnóstico , Enfermedades Testiculares/mortalidad , Enfermedades Testiculares/terapia , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/mortalidad , Tromboembolia Venosa/terapia
11.
Mayo Clin Proc ; 93(1): 40-47, 2018 01.
Artículo en Inglés | MEDLINE | ID: mdl-29217335

RESUMEN

OBJECTIVES: To assess the outcome of direct oral anticoagulants (DOACs), specifically Xa inhibitors: rivaroxaban and apixaban, for the treatment of venous thromboembolism (VTE) of atypical location (VTE-AL), portal, mesenteric, hepatic, splenic, gonadal, renal, and cerebral veins, prospectively collected data of Mayo Thrombophilia Clinic Registry were used. METHODS: Patients with acute VTE-AL treated with DOACs, enrolled between March 1, 2013, and February 1, 2017, were compared with patients with VTE of typical location (VTE-TL: deep vein thrombosis of extremities and/or pulmonary embolism) receiving DOACs and with patients with VTE-AL treated with enoxaparin. RESULTS: Out of 623 patients with acute VTE receiving the study drug within 14 days of diagnosis, there were 63 with VTE-AL: 36 on DOAC, 23 on enoxaparin, and 4 on warfarin; 352 received DOAC for VTE-TL. The VTE-AL treated with DOAC/enoxaparin included the following: splanchnic (26/22), ovarian (8/2), renal (3/5), and cerebral veins (1/1), respectively. Recurrence rate (per 100 person-years) for the VTE-AL group receiving DOAC was 7.3, which was not different when compared with those for VTE-TL (2.4; P=.13) and VTE-AL groups receiving enoxaparin (23.7; P=.37). Major bleeding rate in the VTE-AL group receiving DOAC was not different compared with those for VTE-TL (7.2 vs 3.0; P=.26) and VTE-AL groups on enoxaparin (22.4; P=.31). Mortality was higher in the VTE-AL group on DOAC compared with the VTE-TL group (21.45 [95% CI, 7.87-46.69] vs 8.26 [95% CI, 5.35, 12.20]; P=.03). All patients with VTE-AL with events had cancer. CONCLUSION: The VTE recurrence and bleeding rates for rivaroxaban and apixaban used in VTE-AL are not different from those in patients with VTE-TL and similar to that for enoxaparin.


Asunto(s)
Anticoagulantes/uso terapéutico , Inhibidores del Factor Xa/uso terapéutico , Hemorragia/inducido químicamente , Pirazoles/uso terapéutico , Piridonas/uso terapéutico , Rivaroxabán/uso terapéutico , Tromboembolia Venosa/tratamiento farmacológico , Anciano , Anticoagulantes/efectos adversos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Inhibidores del Factor Xa/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pirazoles/efectos adversos , Piridonas/efectos adversos , Rivaroxabán/efectos adversos
12.
Obstet Gynecol ; 130(5): 1127-1135, 2017 11.
Artículo en Inglés | MEDLINE | ID: mdl-29016487

RESUMEN

OBJECTIVE: To identify the risk of venous thromboembolism recurrence, major bleeding, and mortality in patients with ovarian vein thrombosis so as to better define optimal treatment strategies. METHODS: Patients with ovarian vein thrombosis (1990-2015) and age- and gender-matched patients with contemporary leg deep vein thrombosis (DVT) were assessed for differences in etiology, venous thromboembolism recurrence, and survival in a case-control study. RESULTS: Over the timeframe of this study, only 219 ovarian vein thrombosis cases were identified compared with 13,417 leg DVTs. Median duration of follow-up was 1.23 years (interquartile range 0.25-4.14). Pulmonary embolism was identified at presentation in 6% of patients with ovarian vein thrombosis and 16% of those with DVT (P=.001). Frequent causes of ovarian vein thrombosis included cancer, hormonal stimulation, surgery, and hospitalization. Cancer was twofold more frequent in patients with ovarian vein thrombosis (44% compared with 21%; P<.01). Despite being less frequently treated with anticoagulation (ovarian vein thrombosis 54% compared with DVT 98%, P<.001), venous thromboembolism recurrence rates were similar between groups (ovarian vein thrombosis 2.3 compared with DVT 1.8 per 100 patient-years, P=.49). A personal history of venous thromboembolism and preceding surgery was found to be an independent risk factor for venous thromboembolism recurrence among those treated with anticoagulation (hazard ratio 6.7, P=.04 and hazard ratio 13.6, P=.03, respectively). There was no significant difference in overall survival. CONCLUSION: Ovarian vein thrombosis is a rare thrombotic condition with an incidence 60-fold lower compared with leg DVT in our institution. The striking association with cancer adversely affects overall survival rates in patients with ovarian vein thrombosis. Venous thromboembolism recurrence rates argue for anticoagulation with a direct oral anticoagulant or vitamin K antagonist, particularly in those with a history of venous thromboembolism.


Asunto(s)
Enfermedades del Ovario/complicaciones , Ovario/irrigación sanguínea , Tromboembolia Venosa/epidemiología , Trombosis de la Vena/complicaciones , Adulto , Anciano , Anticoagulantes/uso terapéutico , Estudios de Casos y Controles , Femenino , Humanos , Incidencia , Persona de Mediana Edad , Neoplasias/epidemiología , Neoplasias/etiología , Enfermedades del Ovario/tratamiento farmacológico , Modelos de Riesgos Proporcionales , Recurrencia , Factores de Riesgo , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/etiología , Trombosis de la Vena/tratamiento farmacológico
13.
Thromb Haemost ; 117(10): 1952-1961, 2017 10 05.
Artículo en Inglés | MEDLINE | ID: mdl-28837207

RESUMEN

Currently, low molecular weight heparin (LMWH) is the guideline endorsed treatment of patients with cancer associated venous thromboembolism (VTE). While apixaban is approved for the treatment of acute VTE, there are limited data supporting its use in cancer patients. The rationale and design of this investigator initiated Phase IV, multicenter, randomized, open label, superiority trial assessing the safety of apixaban versus dalteparin for cancer associated VTE is provided (ADAM-VTE; NCT02585713). The main aim of the ADAM-VTE trial is to test the hypothesis that apixaban is associated with a significantly lower rate of major bleeding compared to dalteparin in the treatment of cancer patients with acute VTE. The primary safety outcome is rate of major bleeding. Secondary efficacy objective is to assess the rates of recurrent VTE or arterial thromboembolism. Cancer patients with acute VTE (n=300) are randomized to receive apixaban (10 mg twice daily for 7 days followed by 5 mg twice daily thereafter) or dalteparin (200 IU/Kg daily for 30 days followed by 150 IU/kg daily thereafter) for 6 months. Stratification factors used for randomization include cancer stage and cancer specific risk of venous thromboembolism using the Khorana score. Participating centers are chosen from the Academic and Community Cancer Research United (ACCRU) consortium comprised of 90 oncology practices in the United States and Canada. Based on the hypothesis to be tested, we anticipate that these trial results will provide evidence supporting apixaban as an effective treatment of cancer associated VTE at lower rates of major bleeding compared to LMWH.


Asunto(s)
Anticoagulantes/uso terapéutico , Dalteparina/uso terapéutico , Inhibidores del Factor Xa/uso terapéutico , Neoplasias/complicaciones , Pirazoles/uso terapéutico , Piridonas/uso terapéutico , Tromboembolia Venosa/tratamiento farmacológico , Anticoagulantes/efectos adversos , Canadá , Dalteparina/efectos adversos , Inhibidores del Factor Xa/efectos adversos , Femenino , Hemorragia/inducido químicamente , Humanos , Masculino , Neoplasias/sangre , Neoplasias/diagnóstico , Pirazoles/efectos adversos , Piridonas/efectos adversos , Recurrencia , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos , Tromboembolia Venosa/sangre , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/etiología
14.
J Cardiovasc Electrophysiol ; 28(8): 924-930, 2017 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-28543771

RESUMEN

INTRODUCTION: Cardiac pacing from the right ventricular apex is associated with detrimental long-term effects and nonapical pacing locations may be associated with improved outcomes. There is little data regarding complications with nonapical lead positions. The aim of this study was to assess long-term outcomes and lead-related complications associated with differing ventricular lead tip position. METHODS AND RESULTS: All adult patients who underwent dual-chamber pacemaker implantation from 2004 to 2014 were included if they had postprocedure chest radiographs amenable to lead position determination. Long-term outcomes and lead-related complication rates were recorded. These were compared at 5 years between: (1) apical and septal leads, (2) apical and nonseptal nonapical (NSNA), and (3) apical and septal with >40% ventricular pacing. We retrospectively evaluated 3,450 patients, which included 238 with a septal position and 733 with NSNA lead positions. Septal lead position was associated with a lower mortality compared to apical leads (24% vs. 31%, P = 0.02). In patients with greater than 40% pacing, septal leads were associated with significantly higher rates of incident atrial fibrillation compared to apical leads (49% vs. 34%, P = 0.04). NSNA positions were associated with a significantly higher rate of lead dislodgement (4% vs. 2%, P = 0.005) and need for revision (8% vs. 5%, P = 0.005). CONCLUSIONS: Septal pacemaker lead position is associated with a lower mortality compared to apically placed leads, but a higher incidence of atrial fibrillation with higher percentage ventricular pacing. NSNA lead locations are associated with more complications and should be avoided.


Asunto(s)
Fibrilación Atrial/diagnóstico por imagen , Estimulación Cardíaca Artificial/tendencias , Electrodos Implantados/tendencias , Tabiques Cardíacos/diagnóstico por imagen , Marcapaso Artificial/tendencias , Anciano , Fibrilación Atrial/etiología , Estimulación Cardíaca Artificial/efectos adversos , Enfermedades Cardiovasculares/diagnóstico por imagen , Enfermedades Cardiovasculares/terapia , Electrodos Implantados/efectos adversos , Femenino , Humanos , Masculino , Marcapaso Artificial/efectos adversos , Estudios Retrospectivos , Resultado del Tratamiento
15.
J Interv Card Electrophysiol ; 47(3): 313-319, 2016 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-27613185

RESUMEN

PURPOSE: Optimal atrial pacemaker lead position and fixation mechanism have not been determined with regard to effect on complications. We aimed to determine the association between atrial lead-related complications and varying atrial lead tip positions and lead fixation mechanisms. METHODS: All patients who underwent dual-chamber pacemaker implant between 2004 and 2014 were retrospectively reviewed for atrial lead tip position and fixation type. Lead-related complications were assessed by electronic medical record review. Complication rates were compared at 1 year by chi-square analysis and at 5 years using a Kaplan-Meier analysis. RESULTS: During the study period, 3451 patients (mean age 73.9, 53.4 % male) underwent dual-chamber pacemaker placement. Active fixation leads were associated with a higher incidence of pericardial effusion (81 (2.9 %) vs. 6 (1.0 %), p = 0.005) and pericardiocentesis (46 (1.6 %) vs. 2 (0.3 %), p = 0.01) at 1 year compared to passive fixation leads. There was no difference in overall complication rates by fixation type (161 (5.7 %) vs. 29 (4.6 %), p = 0.26). Low atrial septal lead tip position was associated with a higher rate of lead dislodgement (10 (15.2 %)) compared to appendage (46 (1.6 %)), free wall (10 (2.1 %)), or high atrial septal (2 (4.7 %)) positions (p < 0.001). This difference was also reflected in a significantly increased need for lead revision and overall complications. A multivariate analysis which included potential confounders confirmed the association of active fixation leads with an increased rate of perforation-related complications (p = 0.03) and septal lead location with increased rates of dislodgement (p < 0.001). CONCLUSIONS: Active compared to passive lead fixation increases the risk for pericardial effusion requiring pericardiocentesis. There is a clear association between low atrial septal lead position and lead dislodgement requiring lead revision.


Asunto(s)
Dispositivos de Terapia de Resincronización Cardíaca/estadística & datos numéricos , Remoción de Dispositivos/estadística & datos numéricos , Electrodos Implantados/estadística & datos numéricos , Migración de Cuerpo Extraño/epidemiología , Derrame Pericárdico/epidemiología , Anciano , Causalidad , Comorbilidad , Electrodos Implantados/clasificación , Femenino , Humanos , Masculino , Minnesota/epidemiología , Derrame Pericárdico/cirugía , Pericardiocentesis/estadística & datos numéricos , Prevalencia , Implantación de Prótesis , Estudios Retrospectivos , Resultado del Tratamiento
16.
Echocardiography ; 33(10): 1539-1545, 2016 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-27546353

RESUMEN

PURPOSE: Infarct mass as assessed by myocardial-delayed enhancement imaging on cardiac magnetic resonance (CMR) and myocardial blood flow as assessed by real time myocardial perfusion echocardiography (RT-MPE) have been shown to predict adverse events following ST elevation myocardial infarction (STEMI). There has been no published comparison of quantitative assessment using these modalities as predictors of clinical outcomes to date. We compared RT-MPE with CMR for prediction of cardiac events in reperfused STEMI patients. MATERIALS AND METHODS: Consecutive STEMI patients with early reperfusion were studied. RT-MPE and CMR were performed. Perfusion score indices (PSIRT-MPE and PSICMR ) were calculated [sum of segmental perfusion scores/number of segments]. CMR infarct mass (g) and RT-MPE myocardial blood flow (MBF dB/s) were quantified. Patients were followed for cardiac events (death, nonfatal MI, revascularization, angina, and heart failure). RESULTS: All 27 patients (age 62±14; follow-up 3.5±2.6 years) had thrombolysis in myocardial infarction (TIMI) grade 3 flow of infarct vessel. Cardiac events occurred in 17 (63%). Cardiac event patients had higher PSIRT-MPE , PSICMR , infarct mass, and lower MBF. PSIRT-MPE cutoff of 0.3 had an AUC of 0.856 (82% sensitivity, 70% specificity), while a PSICMR cutoff of 0.2 had an AUC of 0.765 (76% sensitivity, 60% specificity). Infarct mass and MBF were independent predictors of cardiac events after adjusting for risk factors (hazard ratios: 20.9 [95% CI 1.8-256] P=.02 and 8.1 [95% CI 1.5-78] P=.01, respectively). CONCLUSIONS: Quantitative RT-MPE performed comparably to CMR for prediction of MACE in STEMI patients supporting a prognostic role for this noninvasive, bedside imaging method.


Asunto(s)
Ecocardiografía/métodos , Imagen por Resonancia Cinemagnética/métodos , Infarto del Miocardio/diagnóstico por imagen , Infarto del Miocardio/cirugía , Imagen de Perfusión Miocárdica/métodos , Revascularización Miocárdica/mortalidad , Adulto , Anciano , Anciano de 80 o más Años , Comorbilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Minnesota/epidemiología , Infarto del Miocardio/mortalidad , Prevalencia , Reproducibilidad de los Resultados , Factores de Riesgo , Sensibilidad y Especificidad , Tasa de Supervivencia , Resultado del Tratamiento
17.
J Interv Card Electrophysiol ; 46(3): 237-43, 2016 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-26898212

RESUMEN

INTRODUCTION: Cardiac implantable electronic device (CIED) leads frequently develop echogenic masses. However, the nature of these masses is not well understood. In patients in whom atrial fibrillation (AF) catheter ablation is planned, there is concern that transseptal puncture may result in cerebrovascular embolism of these masses. The optimal therapeutic strategy in this setting remains undefined. METHODS: We describe six patients identified over a 6-year period (2008-2014) with device lead-based masses prior to or at the time of AF ablation. We examined the anticoagulation strategy and periprocedural management based on mass identification. RESULTS: In all six patients (age 39-73; four males), the device lead mass was found in the right atrium. The average mass size was 11 ± 1.3 mm. The majority of patients were already on anticoagulation (5/6; 83 %), and an intensified anticoagulation regimen was initiated (INR goal 3.0). In all six patients, the size of the device lead mass decreased on repeat imaging. In two sixths (33 %) patients, the lead-based mass completely resolved within 2 months. The remaining four patients had persistent lead-based masses (average follow-up of 10.9 ± 9.6 months). DISCUSSION: We describe a series of patients with CIED lead-based masses found at the time of ablation. These cases illustrate that lead-based masses can disappear while patients are on high-intensity anticoagulation, most compatible with a thrombotic origin. These early data will need to be assessed in larger cohorts for further validation and evaluation of safety.


Asunto(s)
Anticoagulantes/administración & dosificación , Fibrilación Atrial/cirugía , Ablación por Catéter/efectos adversos , Electrodos Implantados/efectos adversos , Trombosis/etiología , Trombosis/prevención & control , Adulto , Anciano , Fibrilación Atrial/complicaciones , Fibrilación Atrial/tratamiento farmacológico , Estudios de Casos y Controles , Desfibriladores Implantables/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Marcapaso Artificial/efectos adversos , Atención Perioperativa/métodos , Premedicación/métodos , Resultado del Tratamiento
18.
J Interv Card Electrophysiol ; 46(2): 115-20, 2016 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-26650730

RESUMEN

PURPOSE: The rates of cardiovascular implantable electronic device (CIED) implantations and cardiac ablation procedures are increasing worldwide. To date, the management of CIED lead thrombi in the peri-ablation period remains undefined and key clinical management questions remained unanswered. We sought to describe the clinical course and management strategies of patients with a CIED lead thrombus detected in the peri-ablative setting. METHODS: We performed a retrospective analysis of all patients who underwent a cardiac ablation procedure at Mayo Clinic Rochester from 2000 to 2014. Patients were included in our study cohort if they had documented CIED lead thrombus noted on peri-ablation imaging studies. Electronic medical records were reviewed to determine the overall management strategy, outcomes, and embolic complications in these patients. RESULTS: Our overall cohort included 1833 patients, with 27 (1.4 %) having both cardiac ablation procedures as well as CIED lead thrombus detected on imaging. Of these 27 patients, 21 were male (77 %), and the mean age was 59.2 years. The mean duration of follow-up was 16.5 months (range 3 days-48.3 months). Anticoagulation was an effective therapeutic strategy, with 11/14 (78.6 %) patients experiencing either resolution of the thrombus or reduction in size on re-imaging. For atrial fibrillation ablation, the most common management strategy was a deferment in ablation with initiation/intensification of anticoagulation medication. For ventricular tachycardia ablations, most procedures involved a modified approach with the use of a retrograde aortic approach to access the left ventricle. No patient had any documented embolic complications. CONCLUSIONS: The incidence of lead thrombi in patients undergoing an ablation was small in our study cohort (1.4 %). Anticoagulation and deferral of ablation represented successful management strategies for atrial fibrillation ablation. For patients undergoing ventricular tachycardia ablation, a modified approach using retrograde aortic access to the ventricle was successful. In patients who are not on warfarin anticoagulation at the time of thrombus detection, we recommend initiation of this medication, with a goal INR of 2-3. For patients on warfarin at the time of thrombus detection, we recommend an intensification of anticoagulation with a goal INR of 3.0.


Asunto(s)
Dispositivos de Terapia de Resincronización Cardíaca/estadística & datos numéricos , Ablación por Catéter/estadística & datos numéricos , Electrodos Implantados/estadística & datos numéricos , Trombosis/epidemiología , Trombosis/prevención & control , Anticoagulantes/administración & dosificación , Ablación por Catéter/instrumentación , Remoción de Dispositivos , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Minnesota/epidemiología , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/prevención & control , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento
19.
Int J Cardiol Heart Vasc ; 8: 103-107, 2015 09 01.
Artículo en Inglés | MEDLINE | ID: mdl-26925456

RESUMEN

INTRODUCTION: Fibrosing mediastinitis (FM) is a rare but fatal disease characterized by an excessive fibrotic reaction in the mediastinum, which can lead to life-threatening stenosis of the pulmonary veins (PV). Catheter-based intervention is currently the only viable option for therapy. However, the current literature on how best to manage these difficult cases, especially in regards to sequential interventions and their potential complications is very limited. METHODS: We searched through a database of all patients who have undergone PV interventions at the Earl H. Wood Cardiac Catheterization Laboratory in Mayo Clinic, Rochester. From this collection, we selected patients that underwent PV intervention to relieve stenosis secondary to FM. RESULTS: Eight patients were identified, with a mean age of 41 years (24-59 years). Five were men, and three were women. Three patients underwent balloon angioplasty alone, and five patients had stents placed. The majority of patients had acute hemodynamic and symptomatic improvement. More than one intervention was required in five patients, four patients had at least one episode of restenosis, and four patients died within four weeks of their first PV intervention. CONCLUSIONS: We describe the largest reported case series of catheter-based intervention for PV stenosis in FM. Although catheter-based therapy improved hemodynamics, short-term vascular patency, and patient symptoms, the rate of life-threatening complications, restenosis, and mortality associated with these interventions was found to be high. Despite these associated risks, catheter-based intervention is the only palliative option available to improve quality of life in severely symptomatic patients with PV stenosis and FM. Patients with PV stenosis and FM (especially those with bilateral disease) have an overall poor prognosis in spite of undergoing these interventions due to the progressive and recalcitrant nature of the disease. This underscores the need for further innovative approaches to manage this disease.

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