Postprocedural Events Research Articles

One swallow does not a summer make but many swallows do: accumulating clinical evidence for nearly-eliminated peri-procedural and 30-day complications with mesh-covered stents transforms the carotid revascularisation field.

Atherosclerotic carotid artery stenosis (CS) continues to be a common cause of acute ischaemic stroke. Optimised medical therapy (OMT), the first-line treatment modality in CS, may reduce or delay – but it does not abolish – CS-related strokes. As per current AHA/ASA and ESC/ESVS/ESO guidelines, carotid artery stenting (CAS) is a less-invasive alternative to carotid endarterectomy (CEA) for CS revascularisation in primary and secondary stroke prevention.Ten-year follow-up from the CREST trial in patients with symptomatic and asymptomatic CS confirmed equipoise of CAS and CEA in the primary endpoint. Nevertheless CAS – using a widely open-cell, first-generation stent and first-generation (distal/filter) neuroprotection – has been criticised for its relative excess of (mostly minor) strokes by 30 days, a significant proportion of which were post-procedural.Atherosclerotic plaque protrusion through conventional carotid stent struts, confirmed on intravascular imaging, has been implicated as a leading mechanism of the relative excess of strokes with CAS vs. CEA, including delayed strokes with CAS. Different designs of mesh-covered carotid stents have been developed to prevent plaque prolapse. Several multi-centre/multi-specialty clinical studies with CGurad MicroNet-Covered Embolic Prevention Stent System (EPS) and RoadSaver/Casper were recently published and included routine DW-MRI cerebral imaging peri-procedurally and at 30 days (CGuard EPS).Data from more than 550 patients in mesh-covered carotid stent clinical studies to-date show an overall 30-day complication rate of ~1% with near-elimination of post-procedural events. While more (and long-term) evidence is still anticipated, these results – taken together with optimised intra-procedural neuroprotection in CAS (increased use of proximal systems including trans-carotid dynamic flow reversal) and the positive 12-month mesh-covered stent data reports in 2017 – are transforming the carotid revascularisation field today.Establishing effective algorithms to identify the asymptomatic subjects at stroke risk despite OMT, and large-scale studies with mesh-covered stents including long-term clinical and duplex ultrasound outcomes, are the next major goals.

Transcatheter aortic valve replacement: perioperative stroke and beyond

ABSTRACTIntroduction: The definition of stroke has changed over time, from a clinical only-based diagnosis to a more complex classification, including both clinical and imaging-based criteria, in part due to widespread use of magnetic resonance imaging (MRI). The increasing number of transcatheter aortic valve replacement (TAVR) procedures in patients with severe aortic valvular stenosis who are considered high-risk surgical candidates has influenced our view on the diagnosis, interpretation, and significance of perioperative stroke during these procedures.Areas covered: In this perspective, we summarize changes in the definition and diagnostic criteria for stroke and transient ischemic attacks. We examine how the introduction of MRI and standardized cognitive tests has affected our understanding of the safety of TAVR procedures. Finally, we review the growing evidence regarding the role of cerebral protection technology during TAVR procedures on cognitive function.Expert commentary: Standardized MRI-based protocols and prospective evaluation of neurologic deficits with a battery of cognitive assessment tests are needed to ensure accurate recognition of postprocedural clinical events in patients undergoing TAVR procedures and to confirm the effectiveness of embolic protection technology.

Use of non-warfarin oral anticoagulants instead of warfarin during left atrial appendage closure with the Watchman device

In the stroke prevention trials of left atrial appendage closure with the Watchman device (Boston Scientific), a postimplantation antithrombotic regimen of 6 weeks of warfarin was used. Given the clinical complexity of warfarin use, the purpose of this study was to study the relative feasibility and safety of using non-warfarin oral anticoagulants (NOACs) instead of warfarin during the peri- and initial postimplantation periods after Watchman implantation. This was a retrospective multicenter study of consecutive patients undergoing Watchman implantation and receiving peri- and postprocedural NOACs or warfarin. Transesophageal echocardiography or chest computed tomography was performed between 6 weeks and 4 months postimplant to assess for device-related thrombosis. Bleeding and thromboembolic events also were evaluated at the time of follow-up. In 5 centers, 214 patients received NOACs (46% apixaban, 46% rivaroxaban, 7% dabigatran, and 1% edoxaban) in either an uninterrupted (82%) or a single-held-dose (16%) fashion. Compared to a control group receiving uninterrupted warfarin (n = 212), the rates of periprocedural complications, including bleeding events, were similar (2.8% vs 2.4%, P = 1). At follow-up, the rates of device-related thrombosis (0.9% vs 0.5%, P = 1), composite of thromboembolism or device-related thrombosis (1.4% vs 0.9%, P = 1), and postprocedure bleeding events (0.5% vs 0.9%, P = .6) also were comparable between the NOAC and warfarin groups. NOACs proved to be a feasible peri- and postprocedural alternative regimen to warfarin for preventing device-related thrombosis and thromboembolic complications expected early after appendage closure with the Watchman device, without increasing the risk of bleeding.

Carotid body resection for sympathetic modulation in systolic heart failure: results from first-in-man study.

Augmented reflex responses from peripheral chemoreceptors, which are mainly localized in the carotid bodies (CBs), characterize patients with systolic heart failure and contribute to adrenergic hyperactivation. We investigated whether surgical resection of CBs in these patients can be performed safely to decrease sympathetic tone. We studied 10 male patients with systolic heart failure (age, 59 ± 3 years; LVEF, 27 ± 7%) who underwent unilateral right-sided CB resection (four patients) or bilateral CB resection (six patients). Primary endpoints of the study were changes in muscle sympathetic nerve activity (MSNA) and peripheral chemosensitivity measured as ventilatory response to hypoxia from baseline to 1 month post-CB resection. Safety analysis included analysis of arterial blood gas and oxygenation at night through 2 months post-procedure and adverse events assessed up to 12 months. At the 1-month visit, CB resection was associated with a significant decrease both in MSNA (86.6 ± 3.1 vs. 79.7 ± 4.2 bursts/100 beats, P = 0.03) and in peripheral chemosensitivity (1.35 ± 0.19 vs. 0.41 ± 0.17 L/min/SpO2 , P = 0.005). It also resulted in improved exercise tolerance. Amongst some patients with bilateral CB resection, there was a trend towards worsening of oxygen saturation at night, which in one case required therapy with non-invasive ventilation. We present first-in-man evidence that CB resection in patients with systolic heart failure is associated with a decrease in sympathetic activity. A bilateral procedure may carry a risk of worsening oxygenation at night. CB modulation constitutes an interesting research avenue, but careful consideration of the balance between safety and efficacy is necessary before further clinical trials.

Quality of life among elderly patients undergoing transcatheter or surgical aortic valve replacement- a model-based longitudinal data analysis.

BackgroundQuality of life (QoL) measurements reported in observational studies are often biased, since patients who failed to improve are more likely to be unable to respond due to death or impairment. In order to observe the development of QoL in patients close to death, we analyzed a set of monthly QoL measurements for a cohort of elderly patients treated for aortic valve stenosis (AS) with special consideration of the effect of distance to death.MethodsQoL in 169 elderly patients (age ≥ 75 years), treated either with transcatheter aortic valve replacement (TAVR; n = 92), surgical aortic-valve replacement (n = 70), or drug-based therapy (n = 7), was evaluated using the standardized EQ-5D questionnaire. Over a two-year period, patients were consulted using monthly telephone interviews or outpatient visits, leading to a total of 2463 time points at which QoL values, New York Heart Association (NYHA) Functional Classification and their status of assistance were assessed. Furthermore, post-procedural clinical events and complications were monitored. Linear and ordered logistic regression analyses with random intercept were carried out, taking into account overall trends and distance to death.ResultsQoL measures decreased slightly over time, were temporarily impaired at month 1 after the initial episode of hospitalization and decreased substantially at the end of life with a measurable effect starting at the sixth from last follow-up (month) before death. Many clinical complications (bleeding complications, stroke, acute kidney injury) showed an impairment of QoL measurements, but the inclusion of lagged variables demonstrated medium term (three months) QoL impairments for access site bleeding only. All other complications are associated with event-related impairments that decreased dramatically at the second and third follow-up interviews (month) after event.ConclusionsDistance to death shows clear effects on QoL and should be taken into account when analyzing QoL measures in the elderly patients treated for aortic valve stenosis.Trial registrationGerman Clinical Trial Register Nr. DRKS00000797

Electronic Health Record Adoption and Rates of In-hospital Adverse Events.

Nationwide initiatives have focused on improving patient safety through greater use of health information technology. We examined the association of hospitals' electronic health record (EHR) adoption and occurrence rates of adverse events among exposed patients. We conducted a retrospective analysis of patient discharges using data from the 2012 and 2013 Medicare Patient Safety Monitoring System. The sample included patients age 18 and older that were hospitalized for one of 3 conditions: acute cardiovascular disease, pneumonia, or conditions requiring surgery. The main outcome measures were in-hospital adverse events, including hospital-acquired infections, adverse drug events (based on selected medications), general events, and postprocedural events. Adverse event rates and patient exposure to a fully electronic EHR were determined through chart abstraction. Among the 45,235 patients who were at risk for 347,281 adverse events in the study sample, the occurrence rate of adverse events was 2.3%, and 13.0% of patients were exposed to a fully electronic EHR. In multivariate modeling adjusted for patient and hospital characteristics, patient exposure to a fully electronic EHR was associated with 17% to 30% lower odds of any adverse event for cardiovascular (odds ratio [OR], 0.80; 95% confidence interval [CI], 0.72-0.90), pneumonia (OR, 0.70; CI, 0.62-0.80), and surgery (OR, 0.83; CI, 0.72-0.96) patients. The associations of EHR adoption and adverse events varied by event type and by medical condition. Cardiovascular, pneumonia, and surgery patients exposed to a fully electronic EHR were less likely to experience in-hospital adverse events.

Intracoronary brachytherapy for in-stent restenosis of drug-eluting stents

PurposeGiven the limited salvage options for in-stent restenosis (ISR) of drug-eluting stents (DES), our high-volume cardiac catheterization laboratory has been performing intracoronary brachytherapy (ICBT) in patients with recurrent ISR of DES. This study analyzes their baseline characteristics and assesses the safety/toxicity of ICBT in this high-risk population. Methods and materialsA retrospective analysis of patients treated with ICBT between September 2012 and December 2014 was performed. Patients with ISR twice in a single location were eligible. Procedural complications included vessel dissection, perforation, tamponade, slow/absent blood flow, and vessel closure. Postprocedural events included myocardial infarction, coronary artery bypass graft, congestive heart failure, stroke, bleeding, thrombosis, embolism, dissection, dialysis, or death occurring within 72 hours. A control group of patients with 2 episodes of ISR at 1 location who underwent percutaneous coronary intervention without ICBT was identified. Unpaired t tests and χ2 tests were used to compare the groups. ResultsThere were 134 (78%) patients in the ICBT group with 141 treated lesions and 37 (22%) patients in the control group. There was a high prevalence of hyperlipidemia (>95%), hypertension (>95%), and diabetes (>50%) in both groups. The groups were well-balanced with respect to age, sex, and pre-existing medical conditions, with the exception of previous coronary artery bypass graft being more common the ICBT group. Procedural complication rates were low in the control and ICBT groups (0% vs 4.5%, P = .190). Postprocedural event rates were low (<5%) in both groups. Readmission rate at 30 days was 3.7% in the ICBT group and 5.4% in the control group (P = .649). ConclusionsThis is the largest recent known series looking at ICBT for recurrent ISR of DES. ICBT is a safe treatment option with similarly low rates (<5%) of procedural and postprocedural complications compared with percutaneous coronary intervention alone. This study establishes the safety of ICBT in a high-risk patient cohort.

Utilisation of bivalirudin and vascular closure devices for same-day discharge after percutaneous coronary and peripheral interventions

Currently the majority of coronary and peripheral interventions are performed with an overnight stay. This increases the cost and does not reduce logistic constraints on hospital resources. We hypothesised that by combining bivalirudin with vascular closure devices we can safely discharge patients on the same day after percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA) without increasing their risk of bleeding. To evaluate the safety and the feasibility of same-day discharge after PCI and PTA using bivalirudin and vascular closure devices. This is a retrospective analysis of 833 consecutive patients who underwent percutaneous procedures in our centre between January 2007 and February 2010. The population was divided into interventional and diagnostic arms. All interventions were done with use of bivalirudin for anticoagulation and vascular closure devices for achieving haemostasis. Haemostasis in the diagnostic cohort was achieved with standard manual compression. The mean time of observation was 30 days. The mean age of patients was 64.3 years. The primary endpoint was any bleeding event meeting GUSTO criteria. The secondary endpoints included local vascular complications, major adverse cardiac and cerebrovascular events, time to ambulation and discharge, as well as need for overnight hospitalisation. In 30-day observation the primary endpoint occurred in 4.0% of patients in the interventional group and in 2.6% of patients in the diagnostic group (p = 0.31). The frequency of local vascular complications was higher in the interventional group although it was not statistically significant (3.1% vs. 2.9%; p = 0.33). Patients from the interventional group were ambulated sooner compared to the diagnostic group (117.5 vs. 131 min; p = 0.003). Time to discharge was 316.4 ± 38.7 min and 214.2 ± 23.4 min for interventional and diagnostic procedures, respectively (p < 0.001). PCI and PTA in the selected group of patients, with use of bivalirudin and vascular closure devices, do not appear to have increased risk of post-procedural events when compared to diagnostic procedures, and can be done safely without the need for an overnight stay.

Cerebrovascular accidents after percutaneous coronary interventions from 2002 to 2014: Incidence, outcomes, and associated variables

Cerebrovascular accident (CVA) and transient ischemic attack (TIA) related to percutaneous coronary intervention (PCI) are relatively rare complications, but they are associated with high morbidity and mortality. Given the evolution of both CVA risk and PCI techniques over time, this study was conducted to evaluate trends in CVA and TIA associated with PCI and to identify variables associated with neurologic events. Consecutive patients undergoing PCI at the Washington Hospital Center between January 2002 and June 2015 were included. Prespecified data were prospectively collected, including baseline and procedural characteristics, in-hospital outcomes, and 1-year mortality. The subjects who had a CVA or TIA during or immediately after PCI were compared with those without procedure-associated CVA or TIA. Overall, 25,626 patients were included in the study. The mean age was 65.0 ± 12.4 years, 16,949 (65.2%) were male, and 7,436 (28.6%) were African American. From 2002 to 2015, 110 neurologic events post-PCI were diagnosed (0.43%); this included 86 CVAs (0.34%) and 24 TIAs (0.09%). The annual rate of postprocedural neurologic events was 0.42% ± 0.12%. There were significant changes in baseline risk factors over time, with increasing age, incidence of insulin-dependent diabetes, and chronic kidney disease. Patients with neurologic events were more often African American (43.6% vs 28.6%, P < .001) with prior history of CVA (24.5% vs 7.8%, P < .001), chronic renal insufficiency (26.6% vs 15.2%, P < .001), and insulin-dependent diabetes (19.1% vs 12.4%, P = .03). Acute myocardial infarction (56% vs 30.4%, P < .001) and cardiogenic shock (20.2% vs 3%, P < .001) were also more common among patients with neurologic events post-PCI. After multivariable adjustment, use of an intraaortic balloon pump was strongly associated with neurologic events (odds ratio [OR] 4.9, 95% CI 2.7-8.8, P < .001), as was prior CVA (OR 2.4, 95% CI 1.4-4.4, P = .002) and African American race (OR 2.4, 95% CI 1.5-3.9, P < .001); there was a borderline association with the use of a thrombus extraction device (OR 1.7, 95% CI 0.9-3.2, P = .09). In-hospital mortality (20.0% vs 1.5%, P < .001) and 1-year mortality (45.0% vs 7.3%, P < .001) were also much higher in patients with neurologic events. Neurologic events post-PCI are associated with markedly worse in-hospital outcomes. The incidence of CVA and TIA post-PCI, however, remained stable over the last 12 years despite an increase in risk factors for CVA.

Abstract 13454: The Impact of Prior Stroke on the Outcome of Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement

Introduction: Prior stroke has been identified as an independent correlate for post-procedure cerebrovascular events (CVE) in aortic stenosis (AS) patients undergoing surgical aortic valve replacement (SAVR). The present study aimed to evaluate the impact of prior cerebrovascular events on outcome in AS patients undergoing TAVR. Methods: Patients with severe AS undergoing TAVR between May 2007-March 2015 were included and categorized to patients with and without prior CVE defined as stroke and transit ischemic attack. Baseline, procedural characteristics, in-hospital outcomes, 1-month and 1-year mortality were compared, in accordance with the VARC-2 consensus. Results: A cohort of 662 consecutive patients with severe AS undergoing TAVR was included in the analysis. Of these, 120 patients had prior CVE, and 542 without. Balloon expandable valve was used in 70.7% and self-expandable valve in 29.3% of the patients. Trans-femoral access was used in 78% (571), and pre-TAVR balloon aortic valvuloplasty was performed in 87% (574). Patients with prior CVE had a higher mean STS score compared to those without prior CVE (10.1% versus 8.8%, respectively; p=0,006) and demonstrated higher rates of atherosclerotic disease involving the coronary, peripheral and carotid arteries. In-hospital minor stroke occurred more often in patients with prior CVE vs. those without CVE (3.3% vs. 0.7%; p=0.04). However, similar mortality rates were recorded at 1, 6, and 12 months (figure 1), and there were no significant differences in major stroke, bleeding, or post-procedure hospital stay between both groups. Conclusions: Prior history of CVE infers a higher risk for in-hospital minor stroke, yet no impact on other outcomes post TAVR. Patients with and without a history of prior CVE with severe aortic stenosis will similarly benefit from TAVR. Therefore, a history of CVE should not be considered an exclusion criterion.

Abstract 14347: Septal Myectomy is Associated With Worse In-Hospital Outcomes than Alcohol Septal Ablation: Data From the Nationwide Inpatient Sample in the United States, 2003-2011

Introduction: Septal myectomy (SM) and alcohol septal ablation (ASA) are performed for treatment of obstructive hypertrophic cardiomyopathy (HCM). Previous studies comparing ASA and SM are limited to single center registries. We aimed to compare in-hospital outcomes after ASA and SM within a large, national inpatient database. Hypothesis: SM is associated with worse in-hospital outcomes than ASA, particularly in low volume centers. Methods: We analyzed all patients who were hospitalized for ASA (n=6,386) or SM (n=4,862) in the Nationwide Inpatient Database from 2003 to 2011. Rates of adverse in-hospital events (death, stroke, bleeding, acute renal failure (ARF) and need for permanent pacemaker (PPM)) were examined. Multivariate adjusted analysis was performed to compare outcomes based on tertiles of hospital volume. Results: Patients undergoing SM were younger, more likely to be female, have anemia, chronic pulmonary disease, diabetes with complications, obesity, peripheral vascular disease and coagulopathy. The incidence of in-hospital death (5.2% vs. 0.7%), post-procedural stroke (1.8% vs. 0%) and ARF (9.7% vs. 3.3%) were greater in SM vs. ASA groups, respectively (all p&lt;0.001). After adjustment for baseline differences and confounders using multivariate propensity-score adjusted logistic regression analysis, SM remained an independent predictor of in-hospital death (OR 5.59, 95%CI 3.71-8.43), stroke (OR 3.81, 95% CI 2.06-7.07) and ARF (OR 2.23, 95% CI 1.77-2.90). In addition, low hospital volume of SM was an independent predictor of mortality (adj OR 3.11, 95% CI 1.98-4.89) and bleeding (adj OR 3.77, 95% CI 2.12-6.70), while low volume of ASA was not independently associated with an increased risk of adverse post-procedural events. Conclusions: In conclusion, SM was associated with worse in-hospital outcomes, including death, stroke and acute renal failure. Low volume status is associated with worse in-hospital outcomes for SM but not for ASA.

Associations between Cerebral Embolism and Carotid Intraplaque Hemorrhage during Protected Carotid Artery Stenting.

Carotid artery stent placement in patients with intraplaque hemorrhage remains controversial because of the incidence of cerebral embolism after the procedure. The purpose of this study is to determine if intraplaque hemorrhage is a significant risk factor for cerebral embolism during carotid artery stent placement. This prospective study assessed 94 consecutive patients with severe carotid stenosis. These patients underwent preprocedural carotid MR imaging and postprocedural DWI after carotid artery stent placement. Intraplaque hemorrhage was defined as the presence of high signal intensity within the carotid plaque that was >200% of the signal from the adjacent muscle on MPRAGE. We then analyzed the incidence of postprocedural ipsilateral ischemic events on DWI and primary outcomes within 30 days of carotid artery stent placement. Forty-three patients (45.7%) had intraplaque hemorrhage on an MPRAGE image. There was no significant difference in the incidence of postprocedural ipsilateral ischemic events and primary outcomes between the intraplaque hemorrhage and non-intraplaque hemorrhage group. However, postprocedural ipsilateral ischemic events were more frequently observed in the symptomatic group (17/41 [41.5%]) than in the asymptomatic group (8/53 [15.1%]; P = .005). Intraplaque hemorrhage was not a significant risk factor for cerebral embolism during carotid artery stent placement in patients with severe carotid stenosis. Symptomatic patients should receive more careful treatment during carotid artery stent placement because of the higher risk of postprocedural ipsilateral ischemic events.

Left Atrial Appendage Ligation in Nonvalvular Atrial Fibrillation Patients at High Risk for Embolic Events With Ineligibility for Oral Anticoagulation: Initial Report of Clinical Outcomes

ObjectivesThis study sought to assess long-term clinical outcomes in adults with nonvalvular atrial fibrillation (AF) who are ineligible for oral anticoagulation therapy and underwent left atrial appendage (LAA) ligation with the Lariat device. BackgroundLAA exclusion has been used to prevent thrombus formation within the LAA in AF patients and is believed to decrease the risk of cardioembolic events. MethodsLAA ligation with the Lariat device was performed in 139 patients with nonvalvular AF. LAA closure was verified during the procedure by LA angiography and transesophageal echocardiography. A follow-up transesophageal echocardiography was performed at 30 to 45 days post-procedure. After the procedure, patients received aspirin only, clopidogrel only, aspirin plus clopidogrel, or no antithrombotic drugs. Patients did not receive transition oral anticoagulation therapy post-LAA ligation. Patients were followed for LAA closure and adverse events, including stroke, systemic events, and death. ResultsAcute closure was accomplished in 138 of 139 treated patients (99%). In 1 patient, a posterior lobe was partially closed. At the day-30 to day-45 transesophageal echocardiography (n = 127), 114 (90%) had complete LAA closure, and 13 (10%) had a 2- to 4-mm leak. There were no leaks ≥5 mm. The periprocedural adverse event rate was 11.5%, including 2 cardiac perforations and 1 death due to pulmonary embolus. Over a mean follow-up of 2.9 ± 1.1 years, the event rate for the composite endpoint of stroke and systemic embolism was 1.0% per year (n = 4). The combined stroke, embolism, and death of any cause event rate was 2.8% (n = 11) per year. ConclusionsThe findings from this analysis of post-procedure event rates suggest that LAA ligation with the Lariat device effectively closes the LAA and may be a beneficial approach to reduce the risk of embolic events in AF patients ineligible to oral anticoagulation therapy. However, future randomized clinical trials are needed to verify these results and to determine device and procedural safety.

A numerical investigation of the functionality of coronary bifurcation lesions with respect to lesion configuration and stenosis severity

The intervention of coronary bifurcation lesions is associated with higher rates of peri- and post-procedural clinical events compared to the treatment of isolated lesions. Overall, the factors that influence the dynamics of these types of configurations are still not well understood. A geometric multiscale model, consisting of a 3D representation of the left main coronary artery bifurcation and a 0D representation of the rest of the cardiovascular system, was developed. Computational fluid dynamics simulations of the 3D domain were executed by implementing the multiscale algorithm, in order to characterize the functionality of different multilesional configurations as a function of stenosis severity. The investigation found that coronary branch steal has a significant impact on the functionality of the disease and can render a two-lesion configuration more severe compared to a three-lesion configuration. As a result of the complexity of this phenomenon, it was also suggested that certain lesion configurations could result in false negatives in diagnosis when employing a pullback pressure recording across the tandem lesions. In conclusion, this study showed that coronary bifurcation lesions are subject to intricate haemodynamic interactions which render the characterization of their functionality complex and could have significant clinical implications with regards to their diagnosis and prognosis.

Implications from neurologic assessment of brain protection for total arch replacement from a randomized trial

ObjectiveThe study objective was to perform a randomized trial of brain protection during total aortic arch replacement and identify the best way to assess brain injury. MethodsFrom June 2003 to January 2010, 121 evaluable patients were randomized to retrograde (n = 60) or antegrade (n = 61) brain perfusion during hypothermic circulatory arrest. We assessed the sensitivity of clinical neurologic evaluation, brain imaging, and neurocognitive testing performed preoperatively and 4 to 6 months postoperatively to detect brain injury. ResultsA total of 29 patients (24%) experienced neurologic events. Clinical stroke was evident in 1 patient (0.8%), and visual changes were evident in 2 patients; all had brain imaging changes. A total of 14 of 95 patients (15%) undergoing both preoperative and postoperative brain imaging had evidence of new white or gray matter changes; 10 of the 14 patients had neurocognitive testing, but only 2 patients experienced decline. A total of 17 of 96 patients (18%) undergoing both preoperative and postoperative neurocognitive testing manifested declines of 2 or more reliable change indexes; of these 17, 11 had neither imaging changes nor clinical events. Thirty-day mortality was 0.8% (1/121), with no neurologic deaths and a similar prevalence of neurologic events after retrograde and antegrade brain perfusion (22/60, 37% and 15/61, 25%, respectively; P = .2). ConclusionsAlthough this randomized clinical trial revealed similar neurologic outcomes after retrograde or antegrade brain perfusion for total aortic arch replacement, clinical examination for postprocedural neurologic events is insensitive, brain imaging detects more events, and neurocognitive testing detects even more. Future neurologic assessments for cardiovascular procedures should include not only clinical examination but also brain imaging studies, neurocognitive testing, and long-term assessment.

Association of thrombelastographic parameters with post-stenting ischemic events

Background and purposeThrombelastography (TEG) is widely used for the measurement of platelet function. However, few studies have investigated the TEG parameters in patients receiving extracranial or intracranial artery stenting for...

Major complications and mortality within 30 days of an electrophysiological procedure at an academic medical center: implications for developing national standards.

Despite growing attention to performance and quality measures, national standards for reporting of outcomes after all electrophysiology (EP) procedures have not yet been developed. We sought to characterize the incidence and timing of adverse events up to 30 days after EP procedures at a tertiary academic medical center. We prospectively followed all patients undergoing EP procedures between January 2010 and September 2012. All were followed for 30 days postprocedure either in clinic or by telephone. Major complications were defined as events related to the procedure that led to prolongation of hospital stay or readmission, required additional procedural intervention, or resulted in death or significant injury. These were further categorized as intraprocedure, postprocedure, or postdischarge events. Seven EP physicians collectively adjudicated whether complications were directly related to the procedure. A total of 3,213 procedures were performed. Major complications occurred in 2.2% of patients; 49% of these events occurred after discharge. Death occurred in 0.6% of patients; 73% of these deaths were found to be secondary to worsening of the patient's underlying comorbid conditions and unrelated to the procedure. When considering national standards for reporting outcomes of all EP procedures, continued follow-up after discharge is important. In our cohort, half of major complications occurring within 30 days occurred after discharge. In addition, three-quarters of deaths within 30 days were not directly related to the procedure and caution should be used in using all-cause mortality as an outcome measure for EP procedures.

Coronary procedures in German hospitals: a detailed analysis for specific patient clusters.

Evaluation of the classification of the patients with coronary procedures [CP: coronary angiography (CA) and/or percutaneous coronary intervention (PCI)] in Germany to provide valid data as a basis for the evaluation of resource planning and comparison of results from other countries. In the case of CP, most data are restricted to procedures related to acute coronary syndrome (ACS), either STEMI or NSTEMI, and does not cover the whole range of coronary angiographies and therapeutic procedures. To contribute to the clarification of this situation, our analysis was performed. The data of all patients with CP documented according to § 137 German Social Security Code V (SGB V) by hospitals registered under the requirements of § 108 SGB V were analyzed. By cluster analysis, the most important predictors for four short-term clinical outcomes (intra-procedural and post-procedural events, death, length of hospital stay) were identified. Differences were analyzed on a national, federal state and interstate level. In 2012, 764,233 CP were performed in 733,337 patients (64.7 % males) in 890 hospitals. In 88.2 % of all patients, a cardiac disease was detected; in 11.3 %, it was excluded. 5 clusters were identified which were based on the following parameters: ACS, invasive coronary procedure, cardiac disease (i.e., hypertensive cardiac disease, cardiomyopathy, aortic aneurysm, cardiac valve disease), exclusion of CHD. There were significant differences between the five patient clusters: percentages of patients with diabetes, renal insufficiency and CHF varied between 14.1 and 32.9 %, 9.5 and 31.6 %, and 7.0 and 16.9 %, respectively; average duration of hospitalization and death rates varied between 5.5 (without ACS) and 8 days (ACS) and 0.3 and 4.5 %, respectively. The distribution of patient clusters varied significantly between the German federal states as well as within a federal state. Five patient clusters with CP showed significantly differing profiles of risk, outcome and resource consumption as well as a regional distribution. This has to be considered for comparisons between hospitals as well as on a regional and international level and hospital planning.

The REDUCED (A R andomisED stU dy C omparing standard systemic anticoagulation thE rapy to low D ose intracoronary anticoagulation therapy for elective percutaneous coronary intervention) trial. A novel pharmacologic regime for elective percutaneous coronary intervention

Aim This study tried to determine the effi cacy and safety of low-dose intracoronary unfractionated heparin (UFH) in elective percutaneous coronary intervention (PCI).Methods Two-hundred patients who underwent elective PCI of an uncomplicated lesion were included into the study. The patients were assigned to either a control group (70-100 IU/kg intravenous UFH) or a low-dose intracoronary UFH (1,000 IU intracoronary UFH) group.Results At 30 days, the primary end point (composite of death, myocardial infarction, or urgent target vessel revascularization) was similar in both groups [intracoronary UFH group, 1.0%; control group, 2.0%; odds ratio; 0.49 (95% CI: 0.04 - 5.54), P= 0.56]. Post-procedural myocardial injury (according to CK-MB, P= 0.91; according to Tn I, P= 0.81) and bleeding events (based on TIMI criteria, P= 0.33; based on STEEPLE criteria, P= 0.20) were similar in the control and intracoronary groups. The primary end point at 6 months was also similar between the two groups (P = 0.33). Moreover, the health care cost at 30 days of follow-up was lower in the intracoronary group than in the control group (1,016 ± 54 $/patient vs 1,110 ± 102 $/patient, P< 0.001).Conclusion This pilot study suggests that elective PCI could be safely performed with low-dose intracoronary UFH in the treatment of uncomplicated lesions and at a lower cost as compared to standard systemic anticoagulation. These results shou ld be confi rmed by further studies.Clinical trial registration number unique identifi er: NCT01031095

Abstract 17302: A Meta-Analysis of Major Adverse Cardiovascular and Cerebrovascular Events in Patients Undergoing Transcatheter Aortic Valve Implantation Using Edwards SAPIEN valve versus Medtronic CoreValve for Severe Aortic Stenosis

Background: In patients with severe aortic stenosis (AS) who are at high risk for surgery, a transcatheter aortic valve implantation (TAVI) is an emerged alternative procedure using Edwards SAPIEN valve (EV) or Medtronic CoreValve (CV). The purpose of this meta-analysis is to compare early major adverse cardiovascular and cerebrovascular events (MACCE) between EV and CV. Methods: PubMed and the Cochrane Center Register of Controlled Trials were searched through May 2014. Seventeen studies (n=6211) comparing TAVI procedure that used EV (n=2693) and CV (n=3518) were included. End points were post-procedural all-cause mortality, cardiovascular mortality, myocardial infarction, stroke, major bleeding and major vascular events. The odds ratio (OR) with 95% confidence interval (CI) was computed and p&lt;0.05 was considered as a level of significance. Results: The studies were homogeneous for all outcomes except all-cause mortality. There was no significant difference between EV and CV for post-procedural all-cause mortality (OR: 0.82, CI: 0.6-1.13, p=0.23), cardiovascular mortality (OR: 0.7, CI: 0.41-1.2. p=0.2), myocardial infarction (OR: 1.13, CI: 0.51-2.51, p=0.76), stroke (OR: 0.97, CI: 0.66-1.42, p=0.86) (Figure), major bleeding (OR: 1.13, CI: 0.81-1.58, p=0.48) and major vascular complications (OR: 1.22, CI: 0.94-1.58, p=0.14). Conclusion: The results of our meta-analysis of 6211 patients suggest that the types of valve used to perform TAVI procedures do not affect early mortality and MACCE outcomes. Further studies are needed to evaluate long-term outcomes.