External Validation of the Oakland Score to Assess Safe Hospital Discharge Among Adult Patients With Acute Lower Gastrointestinal Bleeding in the US.

Importance: Lower gastrointestinal bleeding (LGIB), which manifests as blood in the colon or anorectum, is a common reason for hospitalization. In most patients, LGIB stops spontaneously with no in-hospital intervention. A risk score that could identify patients at low risk of experiencing adverse outcomes could help improve the triage process and allow greater numbers of patients to receive outpatient management of LGIB. Objective: To externally validate the Oakland Score, which was previously developed using a score threshold of 8 points to identify patients with LGIB who are at low risk of adverse outcomes. Design, Setting, and Participants: This multicenter prognostic study was conducted in 140 US hospitals in the Hospital Corporation of America network. A total of 46 179 adult patients (aged ≥16 years) admitted to the hospital with a primary diagnosis of LGIB between June 1, 2016, and October 15, 2018, were initially identified using diagnostic codes. Of those, 51 patients were excluded because they were more likely to have upper gastrointestinal bleeding, leaving a study population of 46 128 patients with LGIB. For the statistical analysis of the Oakland Score, an additional 8061 patients were excluded because they were missing data on Oakland Score components or clinical outcomes, resulting in 38 067 patients included in the analysis. The study used area under the receiver operating characteristic curves with 95% CIs for external validation of the model. Sensitivity and specificity were calculated for each score threshold (≤8 points, ≤9 points, and ≤10 points). Data were analyzed from October 16, 2018, to September 4, 2019. Main Outcomes and Measures: Identification of patients who met the criteria for safe discharge from the hospital and comparison of the performance of 2 score thresholds (≤8 points vs ≤10 points). Safe discharge was defined as the absence of blood transfusion, rebleeding, hemostatic intervention, hospital readmission, and death. Results: Among 46 128 adult patients with LGIB, the mean (SD) age was 70.1 (16.5) years; 23 091 patients (50.1%) were female. Of those, 22 074 patients (47.9%) met the criteria for safe discharge from the hospital. In this group, the mean (SD) age was 67.9 (18.1) years, and 11 056 patients (50.1%) were female. In the statistical analysis of the Oakland Score, which included only the 38 067 patients with complete data, the area under the receiver operating characteristic curve for safe discharge was 0.87 (95% CI, 0.87-0.87). An Oakland Score threshold of 8 points or lower identified 3305 patients (8.7%), with a sensitivity and specificity for safe discharge of 98.4% and 16.0%, respectively. Extension of the Oakland Score threshold to 10 points or lower identified 6770 patients (17.8%), with a sensitivity and specificity for safe discharge of 96.0% and 31.9%, respectively. Conclusions and Relevance: In this study, the Oakland Score consistently identified patients with acute LGIB who were at low risk of experiencing adverse outcomes and whose conditions could safely be managed without hospitalization. The score threshold to identify low-risk patients could be extended from 8 points or lower to 10 points or lower to allow identification of a greater proportion of low-risk patients.

Laser lead extraction to facilitate cardiac implantable electronic device upgrade and revision in the presence of central venous obstruction.

AIMS: The number of procedures involving upgrade or revision of cardiac implantable electronic devices (CIEDs) is increasing and the risks of adding additional leads are significant. Central venous occlusion in patients with pre-existing devices is often asymptomatic and optimal management of such patients in need of device revision/upgrade is not clear. We sought to assess our use of laser lead extraction in overcoming venous obstruction. METHODS AND RESULTS: Patients in need of device upgrade/revision underwent pre-procedure venography to assess venous patency. In patients with venous occlusion or stenosis severe enough to preclude passage of a hydrophilic guide wire, laser lead extraction with retention of the outer sheath in the vasculature was performed with the aim of maintaining a patent channel through which new leads could be implanted. Data were recorded on a dedicated database and patient outcomes were assessed. Between July 2004 and April 2012, laser lead extractions were performed in 71 patients scheduled for device upgrade/revision who had occluded or functionally obstructed venous anatomy. New leads were successfully implanted across the obstruction in 67 (94%) cases. There were two major complications (infection) and four minor complications with no peri-procedural mortality. Device follow-up was satisfactory in 65 (92%) cases with mean follow-up up to 26 ± 19 months. CONCLUSION: Laser lead extraction is a safe and effective option when managing patients with central venous obstruction in need of CIED revision or upgrade.

Benefits of endocardial and multisite pacing are dependent on the type of left ventricular electric activation pattern and presence of ischemic heart disease: insights from electroanatomic mapping.

BACKGROUND: There is considerable heterogeneity in the myocardial substrate of patients undergoing cardiac resynchronization therapy (CRT), in particular in the etiology of heart failure and in the location of conduction block within the heart. This may account for variability in response to CRT. New approaches, including endocardial and multisite left ventricular (LV) stimulation, may improve CRT response. We sought to evaluate these approaches using noncontact mapping to understand the underlying mechanisms. METHODS AND RESULTS: Ten patients (8 men and 2 women; mean [SD] age 63 [12] years; LV ejection fraction 246%; QRS duration 161 [24] ms) fulfilling conventional CRT criteria underwent an electrophysiological study, with assessment of acute hemodynamic response to conventional CRT as well as LV endocardial and multisite pacing. LV activation pattern was assessed using noncontact mapping. LV endocardial pacing gave a superior acute hemodynamic response compared with conventional CRT (26% versus 37% increase in LV dP/dt(max), respectively; P<0.0005). There was a trend toward further incremental benefit from multisite LV stimulation, although this did not reach statistical significance (P=0.08). The majority (71%) of patients with nonischemic heart failure etiology or functional block responded to conventional CRT, whereas those with myocardial scar or absence of functional block often required endocardial or multisite pacing to achieve CRT response. CONCLUSIONS: Endocardial or multisite pacing may be required in certain subsets of patients undergoing CRT. Patients with ischemic cardiomyopathy and those with narrower QRS, in particular, may stand to benefit.

Percutaneous extraction of cardiac implantable electronic devices (CIEDs) in octogenarians.

BACKGROUND: As the population receiving cardiac device therapy ages, the number of extraction procedures performed in octogenarians is increasing. This group has more comorbidities and may be at higher risk of such procedures. OBJECTIVES: Document the safety and success of percutaneous lead extraction in octogenarians. METHODS: All extraction cases performed between January 2001 and April 2011 entered into a computer database were analyzed for patient characteristics and indications, extraction technique, procedural success, and complications. Success and complications were classified according to the Heart Rhythm Society consensus statement. Outcomes in octogenarians were compared to younger patients undergoing extraction during the same period. RESULTS: Four hundred and six cases were performed: 72 procedures in octogenarians (mean age 84, range 80-95) and 334 in younger adults (mean age 62, range 20-79). Octogenarians had a greater number of comorbidities per case. Infection was the commonest indication for extraction in both groups. One hundred forty-one leads were extracted in octogenarians and 657 in younger patients. Laser assistance was required in 51.4% of octogenarians versus 49.7% of younger patients. Procedural success was achieved in 71/72 (98.6%) octogenarians versus 329/334 (98.5%) younger patients. No procedural mortality occurred in either group. Overall, complications were more frequent in octogenarians with major and minor complications occurring in 2.8 and 8.3% of octogenarians versus 0.6 and 3.0% of younger patients (P = 0.014). CONCLUSIONS: Procedural success was equally high in octogenarians and younger patients. Percutaneous lead extraction can be performed effectively and safely in octogenarians and is associated with a higher complication rate but no increased mortality.

Percutaneous lead and system extraction in patients with cardiac resynchronization therapy (CRT) devices and coronary sinus leads.

BACKGROUND: Cardiac resynchronization therapy (CRT) device and coronary sinus (CS) lead extraction is required due to the occurrence of system infection, malfunction, or upgrade. Published series of CS lead extraction are limited by small sample sizes. We present a 10-year experience of CRT device and CS lead extraction. METHODS: All lead extractions between 2000 and 2010 were entered into a computer database. From these, a cohort of 71 cases involving a CRT device or CS lead was analyzed for procedural method, success, and complications. RESULTS: Sixty coronary sinus leads were extracted in 71 cases (median age 71 years; 90% male) by manual traction/locking stylets (n = 54) or using a laser sheath (n = 6). Procedural success was achieved in 98% of CS leads. A total of 143 non-CS leads were extracted, with laser required in 46% of cases. The mean duration of lead implantation was 35.8 months (range 1-116 months) and 2.86 ± 1.07 leads were extracted per case. CRT extraction case load increased significantly over time. Minor complications occurred in four (5.6%) cases and major complications in one (1.4%) case. There were no intraprocedural deaths, but two deaths occurred within 30 days of extraction. CONCLUSIONS: Our 10-year experience confirms that percutaneous removal of CS leads can be achieved with high procedural success. Our recorded complication rates are no higher than those of non-CS lead extraction series, and should be taken in the context of the frail nature of CRT patients. Ongoing audit of procedure success and complications will be required to further guide best practice in CS lead extraction.

A simultaneous X-Ray/MRI and noncontact mapping study of the acute hemodynamic effect of left ventricular endocardial and epicardial cardiac resynchronization therapy in humans.

BACKGROUND: Cardiac resynchronization therapy (CRT) using endocardial left ventricular (LV) pacing may be superior to conventional CRT. We studied the acute hemodynamic response to conventional CRT and LV pacing from different endocardial sites using a combined cardiac MRI and LV noncontact mapping (NCM) protocol to gain insights into the underlying mechanisms. METHODS AND RESULTS: Fifteen patients (age, 63 ± 10 years; 12 men) awaiting CRT were studied in a combined x-ray and MRI laboratory. Delayed-enhancement cardiac magnetic resonance was performed to define areas of myocardial fibrosis. Patients underwent an electrophysiological study incorporating endocardial and epicardial LV pacing. Acute hemodynamic response was measured using a pressure wire within the LV cavity to derive LV dP/dt max. NCM was used to define areas of slow conduction. There was a significant improvement in all LV pacing modes versus baseline (P<0.001). LV endocardial CRT from the best endocardial site was superior to conventional CRT, with a 79.8 ± 49.0% versus 59.6 ± 49.5% increase in LV dP/dt max of from baseline (P<0.05). The hemodynamic benefits of pacing were greater when LV stimulation was performed outside of areas of slow conduction defined by NCM (P<0.001). Delayed-enhancement cardiac magnetic resonance was able to delineate zones of slow conduction seen with NCM in ischemic patients but was unreliable in nonischemic patients. CONCLUSIONS: Endocardial LV pacing appears superior to conventional CRT, although the optimal site varies between subjects and is influenced by pacing within areas of slow conduction. Delayed-enhancement cardiac magnetic resonance was a poor predictor of zones of slow conduction in nonischemic patients.

Pacemaker and defibrillator lead extraction: predictors of mortality during follow-up.

BACKGROUND: Extraction of cardiac implantable electric devices is an accepted procedure when systems become infected or malfunction. However, there is an associated morbidity and mortality. We report our 5-year experience and identify predictors of mortality, and long-term follow-up. METHODS: We analyzed extraction data from January 2003 to November 2007. Extraction methods used were: locking stylets, telescoping sheaths +/- laser, and femoral work stations. RESULTS: One hundred and eighty-three cases were referred, aged 65 +/- 16 years (range 28-83); 76% were males. Mean implant time was 75 months (range 4-312 months) and indications were: pocket infection (48%), nonfunctioning lead (22%), erosion through skin (18%), endocarditis/septicemia (11%), bilateral superior vena cava thrombosis (0.5%), and painful lead (0.5%). The number of leads extracted were 369, with complete removal in 90.7% and partial in 7.6%. There were no intraoperative deaths but five (2.7%) died within the same admission as their extraction from overwhelming sepsis. Twelve deaths (6.6%) occurred during an average follow-up of 965 days (range 40-1670). Multivariate logistic regression demonstrated that C-reactive protein preprocedure was predictive of acute in-hospital mortality. CONCLUSIONS: Intravascular lead extraction is a safe and efficient method of removing leads. However, there is a subgroup of patients with systemic sepsis with raised inflammatory markers who are at high risk of in-hospital mortality. Long-term follow-up demonstrates mortality which is a marker of the underlying etiology for device implantation, with heart failure patients particularly at risk.

Extraction of chronic pacemaker and defibrillator leads from the coronary sinus: laser infrequently used but required.

AIMS: Cardiac resynchronization therapy is an accepted treatment for heart failure but it may be necessary to explant these systems along with their leads. The evidence base for coronary sinus (CS) lead extractions is limited. We aimed to evaluate the percutaneous removal of these leads and the utility of laser extraction when necessary. METHODS AND RESULTS: Of 265 patients referred for lead extraction between January 2004 and June 2008, 32 (12.1%) involved CS leads (30 males, mean age 67 years). Mean implantation time was 26.5 +/- 28.7 months (range 1-116 months). Indications for extraction were pocket infection (34.4%), lead malfunction (43.8%), skin erosion (15.6%), and endocarditis (6.2%). Twenty-eight (87.5%) CS leads were removed with manual traction, with laser utilized in four cases (12.5%). No major complications of CS laceration, pericardial effusion, emergency surgery, or death occurred. CONCLUSION: Our experience supports the percutaneous extraction of CS leads as a safe and effective procedure including the utility of laser when necessary.

Pocket infection related to retained products of pacing.

With the advent of increasing number of implants and more complex pacing systems, referrals for explantations are likely to increase. These procedures have their attendant peri-procedural risks. We report a delayed complication of a system explant, which could have been avoided, and suggest changes in clinical practice that may prevent similar cases.

Inflammation and coronary calcification in renal patients--factors that may explain increased cardiovascular risk, and poorer results of coronary interventions?

Cardiovascular disease (CVD) is one of the major causes of mortality in patients with renal diseases, with increased odds ratio of mortality with risk factors as diverse as cholesterol, vascular stiffness, chronic inflammation and hyperhomocysteinemia. Several factors have been incriminated to explain the increase in coronary vascular calcification (CVC) in this particular population. Increased duration of dialysis, dyslipidemia, altered calcium-phosphorus metabolism, and chronic inflammation have all been associated with increased CVC. We present here four case reports illustrating the differences in the pathophysiology, therapy and prognosis of calcific coronary heart disease seen in uremic patients.

Cardiac resynchronization therapy in advanced heart failure the multicenter InSync clinical study.

BACKGROUND: recent short-term observations have shown an improvement in cardiac function and heart failure symptoms from atrio-biventricular pacing. This study was designed to assess the safety and feasibility of an atrio-biventricular transvenous pacing system, and examine the long-term effects of cardiac resynchronization in patients with advanced heart failure and ventricular conduction abnormalities. METHODS AND RESULTS: between August, 1997 and November, 1998, 103 patients received a cardiac resynchronization system (CRS) consisting of a pulse generator interfaced with an atrio-biventricular lead system, including a lead designed for left ventricular (LV) pacing via cardiac veins. Baseline evaluation included 12-lead electrocardiogram, estimation of New York Heart Association (NYHA) functional class, assessment of quality of life (QOL), and distance covered during a 6-min walk (6-MW). Detailed echocardiographic data were also collected in a subset of 46 patients. Measurements were repeated in all surviving patients at 1, 3, 6 and 12 months after implantation of the CRS. A single, self-limiting procedure-related complication occurred. Over a follow-up of 12 months, 21 patients died. The 12-month actuarial survival was 78% (CI 70-87%). Nine surviving patients were withdrawn from the study during long-term follow-up for miscellaneous reasons. At each point of follow-up, a significant shortening of QRS duration was measured. In addition, significant improvements were observed in mean NYHA functional class, 6-MW and QOL score. In the 46 patients with complete echocardiographic data, LV ejection fraction increased from 21.7+/-6.4% at baseline to 26.1+/-9.0% at last follow-up (P = 0.006), LV end diastolic dimension decreased from 72.7+/-9.2 to 71.6+/-9.1 mm (P = 0.233), interventricular mechanical delay decreased from 27.5+/-32.1 to 20.3+/-25.5 ms (P = 0.243), mitral regurgitation apical four-chamber area decreased from 7.66+/-5.5 to 6.69+/-5.9 cm(2) (P = 0.197), and left ventricular filling time increased from 363+/-127 to 408+/-111 ms (P = 0.002). CONCLUSIONS: long-term cardiac resynchronization can be safely and reliably achieved by transvenous atrial synchronized right and left ventricular pacing. These changes were accompanied by clinically relevant improvements in functional status and QOL, as well as a measurable increase in LV performance. The outcome of randomised controlled trials is awaited.