Preoperative prediction of Bleeding Independently associated with Mortality after noncardiac Surgery (BIMS): an international prospective cohort study.

BACKGROUND: Diagnostic criteria for Bleeding Independently associated with Mortality after noncardiac Surgery (BIMS) have been defined as bleeding that leads to a postoperative haemoglobin <70 g L-1, leads to blood transfusion, or is judged to be the direct cause of death. Preoperative prediction guides for BIMS can facilitate informed consent and planning of perioperative care. METHODS: In a prospective cohort study of 16 079 participants aged ≥45 yr having inpatient noncardiac surgery at 12 academic hospitals in eight countries between 2007 and 2011, 17.3% (2782) experienced BIMS. An electronic risk calculator for BIMS was developed and internally validated by logistic regression with bootstrapping, and further simplified to a risk index. Decision curve analysis assessed the potential utility of each prediction guide compared with a strategy of identifying risk of BIMS based on preoperative haemoglobin <120 g L-1. RESULTS: With information about the type of surgery, preoperative haemoglobin, age, sex, functional status, kidney function, history of high-risk coronary artery disease, and active cancer, the risk calculator accurately predicted BIMS (bias-corrected C-statistic, 0.84; 95% confidence interval, 0.837-0.852). A simplified index based on preoperative haemoglobin <120 g L-1, open surgery, and high-risk surgery also predicted BIMS, but less accurately (C-statistic, 0.787; 95% confidence interval, 0.779-0.796). Both prediction guides could improve decision making compared with knowledge of haemoglobin <120 g L-1 alone. CONCLUSIONS: BIMS, defined as bleeding that leads to a postoperative haemoglobin <70 g L-1, leads to blood transfusion, or that is judged to be the direct cause of death, can be predicted by a simple risk index before surgery. CLINICAL TRIAL REGISTRATION: NCT00512109.

Bleeding Independently associated with Mortality after noncardiac Surgery (BIMS): an international prospective cohort study establishing diagnostic criteria and prognostic importance.

BACKGROUND: We aimed to establish diagnostic criteria for bleeding independently associated with mortality after noncardiac surgery (BIMS) defined as bleeding during or within 30 days after noncardiac surgery that is independently associated with mortality within 30 days of surgery, and to estimate the proportion of 30-day postoperative mortality potentially attributable to BIMS. METHODS: This was a prospective cohort study of participants ≥45 yr old having inpatient noncardiac surgery at 12 academic hospitals in eight countries between 2007 and 2011. Cox proportional hazards models evaluated the adjusted relationship between candidate diagnostic criteria for BIMS and all-cause mortality within 30 days of surgery. RESULTS: Of 16 079 participants, 2.0% (315) died and 36.1% (5810) met predefined screening criteria for bleeding. Based on independent association with 30-day mortality, BIMS was identified as bleeding leading to a postoperative haemoglobin <70 g L-1, transfusion of ≥1 unit of red blood cells, or that was judged to be the cause of death. Bleeding independently associated with mortality after noncardiac surgery occurred in 17.3% of patients (2782). Death occurred in 5.8% of patients with BIMS (161/2782), 1.3% (39/3028) who met bleeding screening criteria but not BIMS criteria, and 1.1% (115/10 269) without bleeding. BIMS was associated with mortality (adjusted hazard ratio: 1.87; 95% confidence interval: 1.42-2.47). We estimated the proportion of 30-day postoperative deaths potentially attributable to BIMS to be 20.1-31.9%. CONCLUSIONS: Bleeding independently associated with mortality after noncardiac surgery (BIMS), defined as bleeding that leads to a postoperative haemoglobin <70 g L-1, blood transfusion, or that is judged to be the cause of death, is common and may account for a quarter of deaths after noncardiac surgery. CLINICAL TRIAL REGISTRATION: NCT00512109.

Prospective Study of Tricuspid Regurgitation Associated With Permanent Leads After Cardiac Rhythm Device Implantation.

BACKGROUND: Tricuspid regurgitation (TR) has been associated with cardiac rhythm device (CRD) implantation with intracardiac lead insertion. However, data on the incidence of postdevice TR are limited and largely from retrospective studies. We hypothesized that permanent lead implantation would be associated with an increase in TR. METHODS: We prospectively included consecutive patients with a clinical indication for CRD. Patients underwent transthoracic echocardiography 1 month before and 1 year after CRD implantation. RESULTS: A total of 328 patients were prospectively enrolled (69 ± 15 years, 38% female). Echocardiograms before and 1 year after CRD were available in 290 patients (15 died, 23 lost to follow-up). Compared with baseline, there was a significant change in TR grade 1 year after CRD insertion (no/trivial TR: 66% vs 29%; mild TR: 29% vs 61%; moderate TR: 3% vs 8%; severe TR 2% vs 2%; P < 0.001 for an increase in TR by at least 1 grade). Compared with baseline, there was a higher prevalence of moderate or severe TR in the 247 patients with CRD without cardiac resynchronization therapy (4% vs 10%, P = 0.004), but no progression in the 43 patients who received cardiac resynchronization therapy (14% vs 11%, P = 1). Multivariable analysis in the patients with less than moderate TR at baseline (n = 274) showed that only a history of atrial fibrillation was independently associated with progression to moderate or severe TR after correction for baseline TR grade (P = 0.013). CONCLUSIONS: One year after endocardial lead insertion, there was a 5% increase in the prevalence of moderate or severe TR, which may be clinically relevant.

Bleeding impacting mortality after noncardiac surgery: a protocol to establish diagnostic criteria, estimate prognostic importance, and develop and validate a prediction guide in an international prospective cohort study.

INTRODUCTION: Various definitions of bleeding have been used in perioperative studies without systematic assessment of the diagnostic criteria for their independent association with outcomes important to patients. Our proposed definition of bleeding impacting mortality after noncardiac surgery (BIMS) is bleeding that is independently associated with death during or within 30 days after noncardiac surgery. We describe our analysis plan to sequentially 1) establish the diagnostic criteria for BIMS, 2) estimate the independent contribution of BIMS to 30-day mortality and 3) develop and internally validate a clinical prediction guide to estimate patient-specific risk of BIMS. METHODS: In the Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) study, we prospectively collected bleeding data for 16 079 patients aged 45 years or more who had noncardiac inpatient surgery between 2007 and 2011 at 12 centres in 8 countries across 5 continents. We will include bleeding features independently associated with 30-day mortality in the diagnostic criteria for BIMS. Candidate features will include the need for reoperation due to bleeding, the number of units of erythrocytes transfused, the lowest postoperative hemoglobin concentration, and the absolute and relative decrements in hemoglobin concentration from the preoperative value. We will then estimate the incidence of BIMS and its independent association with 30-day mortality. Last, we will construct and internally validate a clinical prediction guide for BIMS. INTERPRETATION: This study will address an important gap in our knowledge about perioperative bleeding, with implications for the 200 million patients who undergo noncardiac surgery globally every year. Trial registration: ClinicalTrials.gov, no NCT00512109.

Percutaneous left atrial appendage Closure for Thromboembolic Prevention in atrial Fibrillation / Cierre percutáneo de la orejuela izquierda para prevención tromboembólica en fibrilación auricular

Background: Atrial fibrillation (AF) produces a five-fold increase in the risk of stroke, and the exclusion of the left atrial appendage (LAA), the main source of thrombi, is an interesting therapeutic option in patients with contraindication for oral anticoagulation. Objectives: The goal of this study was to evaluate the initial experience, immediate results and outcome at 45 days of percutaneous closure of the LAA in patients with AF and high risk of thromboembolic events, in whom chronic oral anticoagulation was contrain-dicated. Methods: Twenty-two patients with non-valvular AF and a CHA2DS2-Vasc ≥2 in whom there was contraindication or impossibility of long-term oral anticoagulation underwent percutaneous closure of the LAA with the WATCHMANT device. The patients were evaluated 45 days after the procedure by clinical assessment and transesophageal echocardiography. Results: The implant was successful in 21 of 22 patients (95.4%). Median (interquartile range) age and CHA2DS2-VASc and HAS-BLED scores were 76 years (IQR 14.5), 5 (IQR 1.5) and 4 (IQR 1), respectively. Three (13.6%) periprocedural complications were observed: one cardiac tamponade requiring surgery, one concealed major bleeding and one pseudoaneurysm of the femoral artery. No device-related complications or thromboembolic events were observed during the 45-day follow-up. The LAA was adequately excluded in 95% of the cases. Conclusions: In our initial experience, the procedure is feasible, with an acceptable risk, and can be considered a therapeutic option in patients with AF and high thromboembolic risk who cannot receive oral anticoagulation.

Introducción: La fibrilación auricular (FA) incrementa cinco veces el riesgo de accidente cerebrovascular y la orejuela auricular izquierda (OI) es la principal fuente de formación de trombos, por lo que su exclusión se presenta como una alternativa terapéutica interesante en pacientes con contraindicación para la anticoagulación oral. Objetivos: Evaluar la experiencia inicial, los resultados del implante y la evolución a los 45 días del cierre percutáneo de la OI en pacientes con FA de riesgo tromboembólico alto en los cuales no podía emplearse la anticoagulación oral crónica. Material y métodos: Veintidós pacientes con FA no valvular y CHA2DS2-Vasc ≥2 en los que la anticoagulación a largo plazo estaba contraindicada o era impracticable fueron sometidos al cierre percutáneo de la OI con el dispositivo WATCHMAN®. Los pacientes fueron evaluados a los 45 días mediante control clínico y con ecocardiografía transesofágica. Resultados: El implante fue exitoso en 21 de los 22 pacientes (95,4%). Las medianas (rango intercuartil) de edad, CHA2DS2-VASc y HAS-BLED fueron 76 años (RIC 14,5), 5 (RIC 1,5) y 4 (RIC 1), respectivamente. Se observaron 3 (13,6%) complicaciones periprocedimiento: un taponamiento que requirió revisión quirúrgica, un sangrado mayor oculto y un seudoaneurisma femoral. Durante el seguimiento a 45 días no se observaron complicaciones relacionadas con el dispositivo ni eventos tromboembólicos. En el 95% de los casos, la OI se encontraba adecuadamente excluida. Conclusiones: En nuestra experiencia inicial, el procedimiento es factible con un riesgo aceptable, constituyéndose en una alternativa terapéutica en pacientes con FA de riesgo tromboembólico alto que no pueden recibir anticoagulantes orales.

Prospective study of tricuspid valve regurgitation associated with permanent leads in patients undergoing cardiac rhythm device implantation: Background, rationale, and design.

Given the increasing numbers of cardiac device implantations worldwide, it is important to determine whether permanent endocardial leads across the tricuspid valve can promote tricuspid regurgitation (TR). Virtually all current data is retrospective, and indicates a signal of TR being increased after permanent lead implantation. However, the precise incidence of moderate or greater TR post-procedure, the exact mechanisms (mechanical, traumatic, functional), and the hemodynamic burden and clinical effects of this putative increase in TR, remain uncertain. We have therefore designed a multicenter, international, prospective study of 300 consecutive patients (recruitment completed, baseline data presented) who will undergo echocardiography and clinical assessment prior to, and at 1-year post device insertion. This prospective study will help determine whether cardiac device-associated TR is real, what are its potential mechanisms, and whether it has an important clinical impact on cardiac device patients.

Tricuspid valve regurgitation following temporary or permanent endocardial lead insertion, and the impact of cardiac resynchronization therapy.

BACKGROUND: While some studies indicate that permanent pacemaker implantation is associated with development of tricuspid regurgitation (TR), other studies indicate no association.Little is known about the impact of temporary lead insertion during ablation procedures, or whether therapy (CRT) prevents TR post-device implantation. HYPOTHESIS: We hypothesized that permanent, but nottemporary endocardial leads, are associated with development of TR, and that CRT would prevent (physiologic) TR. METHODS: We performed a retrospective study of consecutive patients who underwent first device or radiofrequency catheter ablation over a 12-month period at a single, tertiary academic center who underwent pre- and post-procedure echocardiography. RESULTS: In the 89 patients in the device group, the degree of TR significantly increased ≥ 1 grade post-permanent lead implantation: 9 had less TR, 46 were unchanged, and 34 had more TR(p=0.005). TR increased in the 62 patients who underwent device implantation without CRT (p=0.005), but did not increase in the 27 patients with CRT (p=0.47). In the 66 patients in the ablation group, there was no significant change in TR post-ablation: 8 had less TR, 48 were unchanged, and 10 had more TR (p=0.31). CONCLUSION: Permanent endocardial lead implantation was associated with an increase in TR; however, patients who underwent device implantation with CRT did not have an increase in TR.Temporary lead insertion during ablation was not associated with changes in the degree of TR. A large, prospective study is needed to accurately define the incidence and exact mechanisms of permanent endocardial lead-related TR.

Electromagnetic interference of communication devices on ECG machines.

BACKGROUND: Use of communication devices in the hospital environment remains controversial. Electromagnetic interference (EMI) can affect different medical devices. Potential sources for EMI on ECG machines were systematically tested. HYPOTHESIS: Communication devices produce EMI on ECG machines. EMI impairs ECG interpretation. METHODS: The communication devices tested were: a global system for mobile communication (GSM) receiver, a code division multiple access (CDMA) receiver, an analog phone, a wireless local area network, and an alpha-numeric pager. EMI was tested on 3 ECG machines: MAC 5000, MAC 1200, and ELI 100. The devices were tested at 2 and 1 meter, 50, 25, and 0 cm from the acquisition module. The ECGs were presented to a heterogeneous group of clinical providers, (medical students, residents, nurses, industry representatives from cardiac devices companies, and attending cardiologists) to evaluate the impact of EMI on ECG interpretation skills. RESULTS: EMI was detected on the MAC 5000 ECG machine when activated GSM, CDMA, and analog phones were placed on top of the acquisition module. No EMI was seen on the other ECG machines or when phones were at a longer distance or deactivated. EMI was incorrectly diagnosed in 18% of the cases. EMI was confused most frequently with atrial fibrillation or flutter (52%), ventricular arrhythmias (22%), and pacemaker dysfunction (26%). Medical students (p < 0.003) and non-cardiology residents (p = 0.05) demonstrated significantly worse performance on EMI interpretation. CONCLUSIONS: Digital and analog phones produce EMI on modern ECG machines when activated in direct contact to the acquisition module. EMI impairs ECG interpretation.

Hypertrophic cardiomyopathy and tachyarrhythmias detected by a pacemaker.

A 56-year-old man came to the Pacemaker Clinic for his regular pacemaker control. He had experienced a syncopal episode in the previous week. He had a previous diagnosis of non-obstructive hypertrophic cardiomyopathy. Due to a previous syncope and documented 2:1 infrahisian block, a dual-chamber permanent pacemaker had been implanted a few years before. The device was interrogated, showing several ventricular high rate episodes. A careful analysis of the stored intracardiac electrograms showed ventricular tachycardia (VT) with 2:1 ventriculoatrial conduction. The following presentation discusses the alternative diagnosis and clinical management in an unusual diagnosis of VT in the presence of non-obstructive hypertrophic cardiomyopathy.

Postoperative low-molecular-weight heparin bridging is associated with an increase in wound hematoma following surgery for pacemakers and implantable defibrillators.

BACKGROUND: The perioperative management of patients receiving oral anticoagulation therapy (OAC) who undergo pacemaker (PM) and defibrillator (ICD) surgery remains controversial. Low-molecular-weight heparin (LMWH) is often used; however, wound hematoma is a common complication. METHODS: At a single academic Canadian center, between July 2003 and June 2005, details of perioperative OAC bridging and the rate of wound hematoma requiring reoperation or interruption of OAC were reviewed for all patients receiving LMWH bridging for PM or ICD surgery. RESULTS: A total of 148 PM/ICD patients underwent perioperative bridging with LMWH. A significant hematoma occurred in 23 patients, requiring reoperation in three patients. No patient died, developed infection, or stroke. The initial bridging regimen included LMWH (enoxaparin 1 mg/kg BID) given until evening prior to surgery, and reinitiated on postoperative day 3. In response to high rates of postoperative hematoma, subsequent protocols omitted the LMWH on the evening before surgery, all postoperative LMWH, or both. The use of LMWH the night before surgery had no effect on hematoma rates (12% vs 17%, P = 0.62); however, the use of any postoperative LMWH increased hematoma rates (23% vs 8%, P = 0.01). Hematoma rates were not increased in patients receiving acetylsalicylic acid (19% vs 16%, P = 0.62) or clopidogrel (25% vs 17%, P = 0.54). In a multivariate analysis, independent predictors of significant wound hematoma included postoperative LMWH (P = 0.001), a higher international normalized ratio on the day of surgery (P = 0.03), and male sex (P = 0.05). CONCLUSION: Elimination of postoperative LMWH was associated with a substantial reduction in hematoma rates following PM and ICD surgery.

Cardiomiopatia hipertrófica e taquiarritmias detectadas por marcapasso / Hypertrophic cardiomyopathy and tachyarrhythmias detected by a pacemaker / Cardiomiopatía hipertrófica y taquiarritmias detectadas por marcapaso

Um homem de 56 anos veio à Clínica de Marcapasso para verificação de rotina de seu marcapasso. Ele havia apresentado um episódio de síncope na semana anterior. O paciente tinha um diagnostico prévio de cardiomiopatia hipertrófica (CMH) não-obstrutiva crônica. Devido a um episódio prévio de síncope e bloqueio infrahisiano 2:1 documentado, um marcapasso permanente de dupla câmara havia sido implantado alguns anos antes. O dispositivo foi verificado, mostrando vários episódios de altas freqüências ventriculares. Uma análise cuidadosa dos eletrogramas intracardíacos armazenados no dispositivo mostrou taquicardia ventricular (TV) com condução ventrículo-atrial 2:1. A seguinte exposição discute o diagnóstico alternativo e o manejo clínico em um diagnóstico não-usual de TV na presença de cardiomiopatia hipertrófica não-obstrutiva.

A 56-year-old man came to the Pacemaker Clinic for his regular pacemaker control. He had experienced a syncopal episode in the previous week. He had a previous diagnosis of non-obstructive hypertrophic cardiomyopathy. Due to a previous syncope and documented 2:1 infrahisian block, a dual-chamber permanent pacemaker had been implanted a few years before. The device was interrogated, showing several ventricular high rate episodes. A careful analysis of the stored intracardiac electrograms showed ventricular tachycardia (VT) with 2:1 ventriculoatrial conduction. The following presentation discusses the alternative diagnosis and clinical management in an unusual diagnosis of VT in the presence of non-obstructive hypertrophic cardiomyopathy.

Un varón de 56 anos vino a la Clínica de Marcapaso para verificación rutinaria de su marcapaso. Él había presentado un episodio de síncopa la semana anterior. El paciente tenía un diagnostico previo de cardiomiopatía hipertrófica (CMH) no obstructiva crónica. Un marcapaso permanente de doble cámara había sido implantado algunos años antes, en virtud de un episodio previo de síncopa y bloqueo infrahisiano documentado 2:1. Se verificó el dispositivo, que presentó varios episodios de altas frecuencias ventriculares. Un análisis cuidadoso de los electrogramas intracardiacos almacenados en el dispositivo reveló taquicardia ventricular (TV) con conducción ventrículo-atrial 2:1. La presente exposición discute el diagnóstico alternativo y el manejo clínico en un diagnóstico no usual de TV en la presencia de cardiomiopatía hipertrófica no obstructiva.

[Real time intracardiac electrograms for the diagnosis of pacemaker malfunction]. / Electrogramas intracardíacos en tiempo real en el diagnóstico de fallas de marcapasos.

Chronic ventricular lead dislodgement is an infrequent complication of pacemaker implantation. Occasionally, the dislodged lead may sense and capture a chamber in which the lead was not originally positioned. Intracardiac real time electrograms and channel markers are useful tools for the diagnosis of pacemaker malfunction. We present the case of a patient with a ventricular lead dislodgement into the atrium. The ventricular lead was able to sense and capture the atrium. Initial diagnosis was performed based on the deductive analysis of intracardiac real time electrograms and channel markers and confirmed by chest X-ray.

Electrogramas intracardíacos en tiempo real en el diagnóstico de fallas de marcapasos / Real time intracardiac electrograms for the diagnosis of pacemaker malfunction

El desplazamiento crónico del catéter ventricular es una complicación infrecuente del implante de marcapasos. Es infrecuente que un catéter desplazado sense y capture en una cámara donde no fue implantado originalmente. Se presenta el caso de un paciente con marcapasos doble cámara en el que el catéter ventricular se desplazó hacia la aurícula derecha. El catéter desplazado permite sensar y capturar la aurícula. El diagnóstico inicial se realizó mediante el análisis deductivo conjunto de los electrogramas en tiempo real y los eventos en los canales de registro ("marker channel"). La radiografía de tórax confirmó el diagnóstico presuntivo.

Chronic ventricular lead dislodgement is an infrequent complication of pacemaker implantation. Occasionally, the dislodged lead may sense and capture a chamber in which the lead was not originally positioned. Intracardiac real time electrograms and channel markers are useful tools for the diagnosis of pacemaker malfunction. We present the case of a patient with a ventricular lead dislodgement into the atrium. The ventricular lead was able to sense and capture the atrium. Initial diagnosis was performed based on the deductive analysis of intracardiac real time electrograms and channel markers and confirmed by chest X-ray.

An unusual mechanism causing inappropriate implantable cardioverter defibrillator shocks: transient reduction in R-wave amplitude.

Inappropriate shocks delivered by the implantable cardioverter defibrillator (ICD) are an increasingly recognized complication. The most frequent cause is related to supraventricular rhythms associated with fast conduction to the ventricles that are incorrectly detected as ventricular tachycardia leading to inappropriate antitachycardia pacing and/or shocks. Oversensing is a frequent cause of inappropriate shocks usually due to increased amplitude of the T-wave secondary to ischaemia or electrolyte disorders that lead to T-wave double counting. We describe an unusual case of T-wave double counting during sinus rhythm caused by transient reduction in R-wave amplitude with no changes in T-wave amplitude resulting in inappropriate shocks.