In-Hospital Outcomes of Transcatheter Aortic Valve Implantation in Patients With End-Stage Renal Disease on Dialysis from a Large National Database.

The outcomes of patients with end-stage renal disease on dialysis (chronic kidney disease stage 5 on dialysis [CKD 5D]) who undergo transcatheter aortic valve implantation (TAVI) are not well described due to the exclusion of this group in randomized trials. We analyzed the National Inpatient Sample database and compared clinical characteristics and in-hospital outcomes for patients with CKD 5D versus those without CKD 5D (nondialysis group) who underwent TAVI in 2011 to 2014 in the United States. The study population included 1,708 patients (4%) with CKD 5D and 40,481 patients (96%) without CKD 5D who underwent TAVI. Patients with CKD 5D were younger (75.3 ± 9.9 vs 81.4 ± 8.4 years, p <0.001), more likely to be men (62.8% vs 52%, p <0.001), and less likely to be Caucasian (73.6% vs 87.8%, p <0.001). Patients with CKD 5D were more likely to have congestive heart failure (16% vs 11.7%, p <0.001), diabetes with chronic complications (19% vs 5.4%, p <0.001), hypertension (86.5% vs 79.3%, p <0.001), and peripheral vascular disease (34.5% vs 29.4%, p <0.001), but were less likely to have atrial fibrillation (38.6% vs 44.8%, p <0.001) and chronic pulmonary disease (27.5% vs 33.6%, p <0.001). In-hospital mortality was significantly higher in the dialysis group (8.2% vs 4%; adjusted odds ratio 2.21, 95% confidence interval1.81 to 2.69, p <0.001) after adjusting for age, gender, co-morbidities, and hospital characteristics in a robust multivariate regression model. In conclusion, patients with CKD 5D who undergo TAVI have a higher in-hospital mortality than those without CKD 5D.

Delirium After Transcatheter Aortic Valve Replacement.

BACKGROUND: Postoperative delirium is associated with increased mortality. Patients undergoing transcatheter aortic valve replacement are at risk for delirium because of comorbid conditions. OBJECTIVE: To compare the incidence, odds, and mortality implications of delirium between patients undergoing transcatheter replacement and patients undergoing surgical replacement. METHODS: The Richmond Agitation-Sedation Scale and the Confusion Assessment Method for the Intensive Care Unit were used to assess arousal level and delirium prospectively in all patients with severe aortic stenosis who had transcatheter or surgical aortic valve replacement at an academic medical center. Multivariable logistic regression was used to determine the relationship between procedure type and occurrence of delirium. Cox regression was used to assess the association between postoperative delirium and 6-month mortality. RESULTS: A total of 105 patients had transcatheter replacement and 121 had surgical replacement. Patients in the transcatheter group were older (median age, 81 vs 68 years; P < .001) and had more comorbid conditions (median Charlson Comorbidity Index, 3 vs 2; P < .001). Patients in the transcatheter group also had lower incidence (19% vs 21%; P = .65) and odds of delirium developing (odds ratio, 0.4; 95% CI, 0.2-0.9; P = .03). Delirium was independently associated with a 3-fold higher mortality by 6 months (hazard ratio, 3.4; 95% CI, 1.3-8.8; P = .01). CONCLUSIONS: Delirium occurs in at least 1 in 5 patients after transcatheter or surgical aortic valve replacement. Delirium is less likely to develop in the transcatheter group but is associated with higher mortality in both groups.

Complete fusion of a percutaneous aortic valve placed after ventricular assist device.

Severe aortic insufficiency following continuous flow left ventricular assist device (LVAD) placement requires intervention. Conventional corrective approaches are varied and morbid. Increasingly, percutaneous solutions, such as transcatheter aortic valve replacement (TAVR), have been used to rescue these patients. The unique flow characteristics in the aortic root following LVAD implantation may have unintended consequences to the TAVR leaflets. We describe the premature fusion of TAVR leaflets following 159 days of LVAD support. TAVR should be used with some caution in patients with continuous flow LVADs.

Managing mitral regurgitation: focus on the MitraClip device.

Based on the principle of surgical edge-to-edge mitral valve repair (MVR), the MitraClip percutaneous MVR technique has emerged as a minimally invasive option for MVR. This catheter-based system has been widely demonstrated to be safe, although inferior to surgical MVR. Studies examining patients with ≥3+ mitral regurgitation (MR) show that, for all patients treated, freedom from death, surgery, or MR ≥3+ is in the 75%-80% range 1 year following MitraClip implantation. Despite its inferiority to surgical therapy, in high-risk surgical patients, data suggest that the MitraClip system can be employed safely and that it can result in symptomatic improvement in the majority of patients, while not precluding future surgical options. MitraClip therapy also appears to reduce heart failure readmissions in the high-risk cohort, which may lead to an economic benefit. Ongoing study is needed to clarify the impact of percutaneous mitral valve clipping on long-term survival in high-risk populations, as well as its role in other patient populations, such as those with functional MR.

Quantitative Imaging Assessment of an Alternative Approach to Surgical Mitral Valve Leaflet Resection: An Acute Porcine Study.

This study reports the initial in vivo use of a combined radiofrequency ablation and cryo-anchoring (RFC) catheter as an alternative to surgical mitral valve (MV) leaflet resection. Radiofrequency ablation thermally shrinks enlarged collagenous tissues, providing an alternative to leaflet resection, and cryo-anchoring provides reversible attachment of a catheter to freely mobile MV leaflets. Excised porcine MVs (n = 9) were tested in a left heart flow simulator to establish treatment efficacy criteria. Resected leaflet area was quantified by tracking markers on the leaflet surface, and leaflet length reductions were directly measured on echocardiography. Leaflet area decreased by 38 ± 2.7%, and leaflet length decreased by 9.2 ± 1.8% following RFC catheter treatment. The RFC catheter was then tested acutely in healthy pigs (n = 5) under epicardial echocardiographic guidance, open-chest without cardiopulmonary bypass, using mid-ventricular free wall access. Leaflet length was quantified using echocardiography. Quantitative assessment of MV leaflet length revealed that leaflet resection was successful in 4 of 5 pigs, with a leaflet length reduction of 13.3 ± 4.6%. Histological, mechanical, and gross pathological findings also confirmed that RFC catheter treatment was efficacious. The RFC catheter significantly reduces MV leaflet size in an acute animal model, providing a possible percutaneous alternative to surgical leaflet resection.

Timeliness of interfacility transfer for ED patients with ST-elevation myocardial infarction.

OBJECTIVES: Most US hospitals lack primary percutaneous coronary intervention (PCI) capabilities to treat patients with ST-elevation myocardial infarction (STEMI) necessitating transfer to PCI-capable centers. Transferred patients rarely meet the 120-minute benchmark for timely reperfusion, and referring emergency departments (EDs) are a major source of preventable delays. We sought to use more granular data at transferring EDs to describe the variability in length of stay at referring EDs. METHODS: We retrospectively analyzed a secondary data set used for quality improvement for patients with STEMI transferred to a single PCI center between 2008 and 2012. We conducted a descriptive analysis of the total time spent at each referring ED (door-in-door-out [DIDO] interval), periods that comprised DIDO (door to electrocardiogram [EKG], EKG-to-PCI activation, and PCI activation to exit), and the relationship of each period with overall time to reperfusion (medical contact-to-balloon [MCTB] interval). RESULTS: We identified 41 EDs that transferred 620 patients between 2008 and 2012. Median MCTB was 135 minutes (interquartile range [IQR] 114,172). Median overall ED DIDO was 74 minutes (IQR 56,103) and was composed of door to EKG, 5 minutes (IQR 2,11); EKG-to-PCI activation, 18 minutes (IQR 7,37); and PCI activation to exit, 44 minutes (IQR 34,56). Door-in door-out accounted for the largest proportion (60%) of overall MCTB and had the largest variability (coefficient of variability, 1.37) of these intervals. CONCLUSIONS: In this cohort of transferring EDs, we found high variability and substantial delays after EKG performance for patients with STEMI. Factors influencing ED decision making and transportation coordination after PCI activation are a potential target for intervention to improve the timeliness of reperfusion in patients with STEMI.

Effect of transcutaneous aortic valve implantation on the Heyde's syndrome.

The association between aortic valve stenosis and gastrointestinal bleeding, traditionally known as Heyde's syndrome, is the result of a quantitative loss of the highest molecular weight von Willebrand multimers (type 2A von Willebrand syndrome). This results in bleeding from areas of high shear stress such as gastrointestinal angiodysplasias. Correction of this bleeding diathesis after surgical aortic valve replacement has been well described. The effect of transcutaneous aortic valve implantation on Heyde's syndrome has yet to be studied. Herein, we report a patient with severe aortic stenosis, type 2A von Willebrand syndrome, and hemorrhagic shock from gastrointestinal bleeding who underwent successful transcutaneous aortic valve implantation.

Effectiveness of mild therapeutic hypothermia following cardiac arrest in adult patients with congenital heart disease.

Mild therapeutic hypothermia (TH) is an established therapy to improve survival and reduce neurologic injury after cardiac arrest. Adult patients with congenital heart disease (ACHD) are at increased risk of sudden cardiac death. The use of TH in this population has not been extensively studied. The aim of this study is to report our institutional experience using this treatment modality in patients with ACHD after cardiac arrest. We performed a retrospective observational study of a cohort of 245 consecutive patients treated with TH after cardiac arrest from 2007 to 2013. Five patients were identified as having complex ACHD with a mean age of 28 years. All were treated with TH according to an institutional protocol utilizing active surface cooling to maintain a core body temperature of 32°C to 34°C for 24 hours after cardiac arrest. Congenital lesions in these 5 patients included anomalous left coronary artery from the pulmonary artery; l-transposition of the great arteries; d-transposition of the great arteries status post atrial switch; unoperated tricuspid atresia, atrial septal defect, and ventricular septal defect with Eisenmenger's physiology; and surgically corrected atrial septal defect, cleft mitral valve, and subaortic membrane. All 5 patients suffered cardiac arrest due to ventricular arrhythmia and all survived to discharge without significant neurologic impairment. Therapeutic interventions included anomalous left coronary artery from the pulmonary artery ligation, percutaneous coronary intervention, and defibrillator implantation. In conclusion, in 5 patients with ACHD, the use of TH after cardiac arrest resulted in 100% survival to hospital discharge with good neurologic outcome postresuscitation.

The clinical utility of gene expression testing on the diagnostic evaluation of patients presenting to the cardiologist with symptoms of suspected obstructive coronary artery disease: results from the IMPACT (Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern) trial.

Accurate, noninvasive evaluation for obstructive coronary artery disease (CAD) remains challenging and inefficient. In this study, 171 patients presenting with stable chest pain and related symptoms without a history of CAD were referred to 6 cardiologists for evaluation. In the prospective cohort of 88 patients, the cardiologist's diagnostic strategy was evaluated before and after gene expression score (GES) testing. The GES is a validated, quantitative blood-based diagnostic test measuring peripheral blood cell expression levels of 23 genes to determine the likelihood of obstructive CAD (at least 1 vessel with ≥ 50% angiographic coronary artery stenosis). The objective of the study was to measure the effect of the GES on diagnostic testing using a pre/post study design. There were 83 prospective patients evaluable for study analysis, which included 57 (69%) women, mean age 53 ± 11 years, and mean GES 12.5 ± 9. Presenting symptoms were classified as typical angina, atypical angina, and noncardiac chest pain in 33%, 60%, and 7% of patients (n = 27, 50, and 6), respectively. After GES, changes in diagnostic testing occurred in 58% of patients (n = 48, P < 0.001). Of note, 91% (29/32) of patients with decreased testing had low GES (≤ 15), whereas 100% (16/16) of patients with increased testing had elevated GES (P < 0.001). A historical cohort of 83 patients, matched to the prospective cohort by clinical factors, had higher diagnostic test use compared with the post-GES prospective cohort (P < 0.001). In summary, the GES showed clinical utility in the evaluation of patients with suspected obstructive CAD presenting to the cardiologist's office.

Comparison of 30-day outcomes of coronary artery bypass grafting surgery verus hybrid coronary revascularization stratified by SYNTAX and euroSCORE.

OBJECTIVE: The optimal treatment of multivessel coronary artery disease is not well established. Hybrid coronary revascularization by combining the left internal mammary artery-left anterior descending artery graft and drug-eluting stents in non-left anterior descending artery territories might offer superior results compared with sole coronary artery bypass grafting or sole percutaneous coronary intervention. METHODS: We retrospectively analyzed the 30-day outcomes of 381 consecutive patients undergoing coronary artery bypass grafting (n = 301) vs hybrid coronary revascularization (n = 80). In a 2 × 2 matrix, the 2 groups were stratified by the Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) score (≤32 vs ≥33) and the European System for Cardiac Operative Risk Evaluation (euroSCORE) (<5 vs ≥5). The composite endpoint (death from any cause, stroke, myocardial infarction, low cardiac output syndrome) and secondary endpoints (worsening postprocedural renal function and bleeding) were determined. RESULTS: After stratification using the SYNTAX and the euroSCORE, the preoperative characteristics were similar within the 4 groups, except for the ≥33 SYNTAX/>5 euroSCORE. The hybrid coronary revascularization patients were older (77 vs 65 years, P = .001). The postoperative outcomes using combined SYNTAX and the euroSCORE stratification showed a similar rate of the composite endpoint for all groups except for patients with ≥33 SYNTAX/>5 euroSCORE (0% for the coronary artery bypass grafting group vs 33% for the hybrid coronary revascularization group, P = .001). An analysis of the secondary endpoint showed similar results across all groups, except for in the ≥33 SYNTAX/>5 euroSCORE group, in which bleeding (re-exploration for bleeding and transfusion >3 packed red blood cell units per patient) was 44% in the hybrid coronary revascularization group vs 11% in the coronary artery bypass grafting group (P = .05). CONCLUSIONS: Hybrid coronary revascularization is a safe alternative to coronary artery bypass grafting in many patients with multivessel coronary artery disease. However, in high-risk patients with complex coronary artery disease (≥33 SYNTAX/>5 euroSCORE), coronary artery bypass grafting is superior to hybrid coronary revascularization.

Clinical pathway: helicopter scene STEMI protocol to facilitate long-distance transfer for primary PCI.

BACKGROUND: The latest American College of Cardiology/American Heart Association guidelines recommend primary percutaneous coronary intervention (PCI) in acute ST-elevation myocardial infarction (STEMI) patients within 90 minutes from presentation to the emergency room. For interhospital transfers, the most recent PCI guidelines recommend first medical contact-to-device times ≤120 minutes. Although PCI-capable hospitals have improved door-to-balloon times, many patients present to non-PCI-capable facilities and have been excluded from national quality measures. METHODS: In our acute myocardial infarction network, not only do we enable non-PCI hospitals to transfer STEMI patients but empower outside emergency medical services (EMS) to activate the catheterization laboratory team with a burst page and transfer STEMI patients directly from the scene. Data on patient characteristics, outcomes, and time elements were collected for "scene STEMI" patients who circumvented outlying rural non-PCI hospitals and are presented in this case series. RESULTS: From December 2007 to November 2010, 22 STEMI patients with higher than average acuity were transported by helicopter directly to our medical center for primary PCI. Median distance from the scene to our medical center was 47 miles [25th to 75th interquartile range (IQR) = 39-71 miles]. Median EMS-to-balloon time was 120 minutes (IQR = 111-134 minutes). There were no false activations by EMS. In comparison, our median time for interhospital STEMI transfers (N = 335) was 145 minutes (IQR = 121-186 minutes) from 2007 to 2009. CONCLUSIONS: In our single-center experience, 22 scene STEMI patients were diagnosed and appropriately triaged by EMS to our center for primary PCI. Our data show feasibility of an EMS-activated STEMI network over long distances with good reperfusion times.

Implementation of a standardized pathway for the treatment of cardiac arrest patients using therapeutic hypothermia: "CODE ICE".

Out-of-hospital cardiac arrest is common and is associated with high mortality. The majority of in-hospital deaths from resuscitated victims of cardiac arrest are due to neurologic injury. Therapeutic hypothermia (TH) is now recommended for the management of comatose survivors of cardiac arrest. The rapid triage and standardized treatment of cardiac arrest patients can be challenging, and implementation of a TH program requires a multidisciplinary team approach. In 2010, we revised our institution's TH protocol, creating a "CODE ICE" pathway to improve the timely and coordinated care of cardiac arrest patients. As part of CODE ICE, we implemented comprehensive care pathways including measures such as a burst paging system and computerized physician support tools. "STEMI on ICE" integrates TH with our regional ST-elevation myocardial infarction network. Retrospective data were collected on 150 consecutive comatose cardiac arrest victims treated with TH (n = 82 pre-CODE ICE and n = 68 post-CODE ICE) from 2007 to 2011. After implementation of CODE ICE, the mean time to initiation of TH decreased from 306 ± 165 minutes to 196 ± 144 minutes (P < 0.001), and the time to target temperature decreased from 532 ± 214 minutes to 392 ± 215 minutes (P < 0.001). There was no significant change in survival or neurologic outcome at hospital discharge. Through the implementation of CODE ICE, we were able to reduce the time to initiation of TH and time to reach target temperature. Additional studies are needed to determine the effect of CODE ICE and similar pathways on clinical outcomes after cardiac arrest.

Peripheral vascular complications during transcatheter aortic valve replacement: management and potential role of chronic steroid use.

PURPOSE: To report a case of a major vascular complication during transcatheter aortic valve replacement (TAVR) and the endovascular management thereof. Additionally, we discuss a possible correlation with long-term steroid use. CASE REPORT: A 79-year-old woman with a history of critical aortic stenosis underwent elective TAVR. Her procedure was complicated by rupture of her right iliac artery, life-threatening retroperitoneal hemorrhage, and thrombus extending into the distal right lower extremity. This case was emergently managed by stent placement, thrombectomy, and tissue plasminogen activator via a percutaneous approach. CONCLUSIONS: Peripheral vascular complications are common during percutaneous TAVR, and chronic steroid use may predispose patients. Endovascular management is often possible and may potentially save valuable time in emergent situations.

Familial dilated cardiomyopathy associated with congenital defects in the setting of a novel VCL mutation (Lys815Arg) in conjunction with a known MYPBC3 variant.

Idiopathic dilated cardiomyopathy (DCM) is a primary myocardial disorder characterized by ventricular chamber enlargement and systolic dysfunction. Twenty to fifty percent of idiopathic DCM cases are thought to have a genetic cause. Of more than 30 genes known to be associated with DCM, rare variants in the VCL and MYBPC3 genes have been reported in several cases of DCM. In this report, we describe a family with DCM and congenital abnormalities who carry a novel missense mutation in the VCL gene. More severely affected family members also possess a second missense variant in MYBPC3, raising the possibility that this variant may be a disease modifier. Interestingly, many of the affected individuals also have congenital defects, including two with bicuspid aortic valve with aortic regurgitation. We discuss the implications of the family history and genetic information on management of at-risk individuals with aortic regurgitation.

Routine intraoperative completion angiography after coronary artery bypass grafting and 1-stop hybrid revascularization results from a fully integrated hybrid catheterization laboratory/operating room.

OBJECTIVES: This study sought to report our experience with a routine completion angiogram after coronary artery bypass surgery (CABG) and simultaneous (1-stop) percutaneous coronary intervention (PCI) at the time of CABG performed in the hybrid catheterization laboratory/operating room. BACKGROUND: The value of a routine completion angiogram after CABG and 1-stop hybrid CABG/PCI remains unresolved. METHODS: Between April 2005 and July 2007, 366 consecutive patients underwent CABG surgery, with (n = 112) or without (n = 254) concomitant 1-stop PCI (hybrid), all with completion angiography before chest closure. Among the 112 1-stop hybrid CABG/PCI patients, 67 (60%) underwent a planned hybrid procedure based on pre-operative assessment, whereas 45 (40%) underwent open-chest PCI (unplanned hybrid) based on intraoperative findings. RESULTS: Among the 796 CABG grafts (345 left internal mammary artery, 12 right internal mammary artery/radial, and 439 veins), 97 (12%) angiographic defects were identified. Defects were repaired with either a minor adjustment of the graft (n = 22, 2.8%), with intraoperative open-chest PCI (unplanned hybrid, n = 48, 6%) or with traditional surgical revision (n = 27, 3.4%). Hybrid patients had clinical outcomes similar to standard CABG patients. CONCLUSIONS: Routine completion angiography detected 12% of grafts with important angiographic defects. One-stop hybrid coronary revascularization is reasonable, safe, and feasible. Combining the tools of the catheterization laboratory and operating room greatly enhances the options available to the surgeon and cardiologist for patients with complex coronary artery disease.