The Comprehensive Assessment of Neurodegeneration and Dementia: Canadian Cohort Study.

BACKGROUND: The Comprehensive Assessment of Neurodegeneration and Dementia (COMPASS-ND) cohort study of the Canadian Consortium on Neurodegeneration in Aging (CCNA) is a national initiative to catalyze research on dementia, set up to support the research agendas of CCNA teams. This cross-country longitudinal cohort of 2310 deeply phenotyped subjects with various forms of dementia and mild memory loss or concerns, along with cognitively intact elderly subjects, will test hypotheses generated by these teams. METHODS: The COMPASS-ND protocol, initial grant proposal for funding, fifth semi-annual CCNA Progress Report submitted to the Canadian Institutes of Health Research December 2017, and other documents supplemented by modifications made and lessons learned after implementation were used by the authors to create the description of the study provided here. RESULTS: The CCNA COMPASS-ND cohort includes participants from across Canada with various cognitive conditions associated with or at risk of neurodegenerative diseases. They will undergo a wide range of experimental, clinical, imaging, and genetic investigation to specifically address the causes, diagnosis, treatment, and prevention of these conditions in the aging population. Data derived from clinical and cognitive assessments, biospecimens, brain imaging, genetics, and brain donations will be used to test hypotheses generated by CCNA research teams and other Canadian researchers. The study is the most comprehensive and ambitious Canadian study of dementia. Initial data posting occurred in 2018, with the full cohort to be accrued by 2020. CONCLUSION: Availability of data from the COMPASS-ND study will provide a major stimulus for dementia research in Canada in the coming years.

Évaluation complète d'une étude de cohorte canadienne portant sur la démence et la neuro-dégénérescence. Contexte : L'évaluation globale de la neuro-dégénérescence et de la démence (COMPASS-ND), étude de cohorte du Consortium canadien en neuro-dégénérescence associée au vieillissement (CCNV), représente une initiative nationale visant à promouvoir la recherche portant sur la démence et à soutenir les programmes de recherche des équipes du CCNV. Totalisant 2310 sujets recrutés partout au pays, cette cohorte longitudinale regroupe des individus fortement « phénotypés ¼ qui présentent diverses formes de démence et de pertes de mémoire légères. En plus de sujets âgés dont les fonctions cognitives sont intactes, ces 2310 sujets ont permis de valider les hypothèses formulées par les équipes du CCNV. Méthodes : Nous avons utilisé de nombreux documents pour décrire cette étude : le protocole de la COMPASS-ND ; la demande initiale de subvention ; le cinquième rapport d'étape semi-annuel du CCNV soumis aux Instituts de recherche en santé du Canada (IRSC) en décembre 2017 ; ainsi que d'autres documents produits à la suite de modifications consécutives à la mise en œuvre de ce projet. Résultats: L'étude de cohorte COMPASS-ND du CCNV inclut des participants de partout au Canada dont les divers états cognitifs sont associés à des maladies neurodégénératives ou au risque d'en souffrir. Ils feront l'objet d'un large éventail d'examens expérimentaux, cliniques, génétiques et d'imagerie afin d'aborder de manière spécifique les causes, le diagnostic, le traitement et la prévention de ces états cognitifs chez les personnes âgées. Les données obtenues à la suite d'évaluations cliniques et cognitives, ainsi que celles issues d'échantillons biologiques, d'imagerie cérébrale, de tests génétiques et de dons de cerveaux, seront utilisées pour tester les hypothèses générées par les équipes de recherche du CCNV et d'autres chercheurs canadiens. Cette étude constitue donc à ce jour l'étude canadienne la plus complète et la plus ambitieuse au sujet de la démence. La présentation des données initiales ayant eu lieu en 2018, la cohorte devrait atteindre sa taille maximale d'ici à 2020.Conclusion : La disponibilité des données de l'étude COMPASS-ND stimulera considérablement la recherche sur la démence au Canada au cours des prochaines années.

The spectrum of electrocardiographic manifestations of acute myocarditis: an expanded understanding.

BACKGROUND AND PURPOSE: Descriptions of the significance of ST segment or QRS abnormalities in myocarditis are limited because documentation of the diagnosis has previously required myocardial biopsy. Late gadolinium enhancement (LGE) and T2 weighted imaging in the midventricular wall on cardiac magnetic resonance imaging (CMRI) has a very good positive predictive value for the diagnosis of myocarditis. We hypothesized to reexplore the diagnostic value of these electrocardiographic (ECG) changes in myocarditis by utilizing CMRI as the reference standard. METHODS: Data on demographics, clinical presentation, laboratory tests, echocardiograms, coronary angiograms, and computed tomography angiography of 41 consecutive patients with definite midventricular or subepicardial LGE and T2 weighted imaging on CMRI were extracted from the available clinical records. ECGs were blindly examined by two independent readers and divided based on (a) STT changes into: 1. No STT changes, 2. STT changes but no ST elevation, 3. ST elevation (STE); and (b) the presence or absence of QRS abnormalities. Associations of these ECG changes with differences in left ventricular ejection fraction, as measured from CMRI was the main aim of this study. In addition, a complete clinical profile of these patients with myocarditis as identified by CMRI was also created. RESULTS: 80% of our study population were male with a mean age of 38.6±15.5 and a paucity of traditional cardiovascular risk factors (<30%). 90% presented with chest pain with more than half having dyspnea and a viral prodrome, but fever was infrequent (15%). Peak troponin-I and creatine kinase-MB levels exceeded the upper limit of normal in latest 85%, often by more than 5 times the limit. 18% had a coronary luminal narrowing of ≥50%, while 56% had echocardiographic wall motion abnormalities. The left ventricular ejection fraction averaged 54.3±10.8%. In 24.4% of patients, the ECG was entirely normal; while 39% had STE. STT changes did not detect any differences in the ejection fraction. An abnormal QRS, which was present in 29%, was associated with a lower left ventricular ejection fraction (p=0.005). CONCLUSIONS: Patients with clinical features suggestive of myocarditis and confirmatory CMRI findings, can present with a variety of ECG findings, some of which have the potential to identify those with a worse cardiac function, and potentially with a worse prognosis.

Safety of bivalirudin in percutaneous coronary intervention following thrombolytic therapy.

OBJECTIVES: This study was undertaken to evaluate the safety of bivalirudin (BIV) use during percutaneous coronary intervention (PCI), following thrombolytic therapy in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND: BIV has emerged as a safer anticoagulant than unfractionated heparin (UFH) during primary PCI; however, its use in patients who receive thrombolytic therapy has not been established. METHODS: A consecutive series of 104 patients who presented with STEMI treated with full-dose thrombolytics and who subsequently received PCI within 6 hr was identified and analyzed. BIV use was compared with UFH for in-hospital bleeding and ischemic events. The primary end points were the rate of major bleeding and the rate of net adverse clinical events as defined in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trial. The study cohort consisted of 104 patients, of whom 47 (45%) received BIV and 57 (55%) received UFH. RESULTS: Patients on BIV were more frequently preloaded with clopidogrel, while intraprocedural glycoprotein IIb/IIIa inhibitors were used only in UFH patients. In-hospital death, ischemic events, and thrombolysis in myocardial infarction major bleeding occurred more frequently in patients treated with UFH. The net adverse clinical events rate was lower in the intraprocedural BIV group (3 [6.4%] vs. 12 [21.1%] UFH, P = 0.034). CONCLUSIONS: The use of BIV in patients presenting with STEMI who were pretreated with thrombolytic therapy and who subsequently underwent PCI is safe and is associated with less ischemic and bleeding events when compared with UFH, and should be considered as the first line anticoagulant for these patients during PCI.

Balloon aortic valvuloplasty for severe aortic stenosis as a bridge to transcatheter/surgical aortic valve replacement.

OBJECTIVES: This study aimed to determine success- and complication rates after balloon aortic valvuloplasty (BAV) and the outcome of BAV as a standalone therapy versus BAV as a bridge to transcatheter/surgical aortic valve replacement (T/SAVR). BACKGROUND: The introduction of transcatheter aortic valve replacement (TAVR) has led to a revival in BAV as treatment for patients with severe aortic stenosis. METHODS: A cohort of 472 patients underwent 538 BAV procedures. The cohort was divided into two groups: BAV alone 387 (81.9%) and BAV as a bridge 85 (18.1%) to (n = 65, TAVR; n = 20, surgery). Clinical, hemodynamic, and follow-up mortality data were collected. RESULTS: There was no significant difference between the two groups in mean age (81.7 ± 8.3 vs. 83.2 ± 10.9 years, P = 0.18), society of thoracic surgeons score (13.1 ± 6.2 and 12.4 ± 6.4, P = 0.4), logistic EuroSCORE (45.4 ± 22.3 vs. 46.9 ± 21.8, P = 0.43), and other comorbidities. The mean increase in aortic valve area was 0.39 ± 0.25 in the BAV alone group and 0.42 ± 0.26 in the BAV as a bridge group, P = 0.33. The decrease in mean gradient was 24.1 ± 13.1 in the BAV alone group vs. 27.1 ± 13.8 in the BAV as a bridge group, P = 0.06. During a median follow up of 183 days [54-409], the mortality rate was 55.2% (n = 214) in the BAV alone group vs. 22.3% (n = 19) in the BAV as a bridge group during a median follow-up of 378 days [177-690], P < 0.001. CONCLUSION: In high-risk patients with aortic stenosis and temporary contraindications to SAVR/TAVR, BAV may be used as a bridge to intervention with good mid-term outcomes.

Outcomes of concomitant percutaneous coronary intervention and balloon aortic valvuloplasty.

BACKGROUND: Coronary artery disease often coexists with severe aortic stenosis. The feasibility and safety of combined balloon aortic valvuloplasty (BAV) and percutaneous coronary intervention (PCI) are unknown. AIM: To compare outcomes and complications of combined BAV and PCI with BAV alone. METHODS: The study cohort consisted of 409 patients with severe aortic stenosis undergoing BAV from 1/2007 to 12/2010. Overall, 329 patients underwent BAV alone and 80 underwent concomitant PCI. Clinical and hemodynamic data, as well as acute and intermediate-term outcomes, were collected. RESULTS: At the operator's discretion PCI was done before BAV in 66 (82.5%) and after in 14 (17.5%). Patients who underwent concomitant procedures had a higher incidence of prior stroke and a lower incidence of atrial fibrillation. Procedure time and fluoroscopic time were significantly greater in the BAV/PCI group, (90.0 ± 36.6 vs. 72.8 ± 39.8, P = 0.002 and 20.5 ± 10.9 vs. 12.9 ± 7.0, P < 0.001). Significantly more radiographic contrast was used in the BAV/PCI group (95.1 ± 45.5 vs. 36.7 ± 38.4 cm(3) , P < 0.001. Serious adverse events occurred with equal frequency 13.7 and 17.3%, P = 0.44). Transfusion requirement was also similar (21.2% vs. 20.0%, P = 0.81). The frequency of a periprocedural increase in troponin or creatinine was also similar. In the BAV alone group the mortality rate was 48.6% (n = 160) during a mean follow-up of 191 days, and in the BAV/PCI group the mortality rate was 40% (n = 32) during mean follow-up of 175.5 day, P = 0.34. CONCLUSION: Combined BAV and PCI are safe and are associated with similar complications as BAV alone and may offer protection against myocardial ischemia during BAV.

The independent value of a direct stenting strategy on early and late clinical outcomes in patients undergoing elective percutaneous coronary intervention.

OBJECTIVES: This study aimed to compare percutaneous coronary intervention (PCI) with direct stenting (DS) to balloon predilatation (PD) for patients undergoing elective PCI to determine whether there is an independent value for DS with regard to clinical outcomes. BACKGROUND: The safety of PCI with DS has been established, but the independent advantages of this technique are not entirely clear. METHODS: Patients undergoing elective PCI from January 2000 to December 2010 were included. The postprocedural and late clinical outcomes of 444 patients who underwent PCI with DS were compared with a propensity-matched population of 444 subjects treated with PD. RESULTS: The two groups were well matched to 27 baseline clinical, procedural, and angiographic characteristics, thus allowing for a more accurate evaluation of the independent value of the stenting technique. Intravascular ultrasound was used in more than 60% of interventions in both groups. PCI performed with PD were longer (DS 45 ± 19.28 vs. PD 56 ± 23.72 minutes, P = 0.001), used more contrast (DS 154 ± 65.88 vs. PD 186 ± 92.84 cc, P = 0.001), and more frequently used balloon postdilation (DS 0% vs. PD 27.3%, P = 0.001). The incidence of periprocedural myocardial infarction (PPMI) was similar between DS- and PD patients (5.3% vs. 5.4%, P = 0.91). Likewise, the 1-year rates of major adverse cardiac events (8.4% vs. 6.3%, P = 0.25), target lesion revascularization (3.9% vs. 2.5%, P = 0.24), and definite stent thrombosis (0.2% vs. 0.9%, P = 0.37) were similar among DS and PD patients, respectively. CONCLUSION: During elective PCI, DS decreases overall procedure time and resource utilization, but fails to reveal an independent clinical advantage as there is no demonstrable benefit in regard to the incidence of PPMI, restenosis, or overall clinical outcomes up to 1-year of follow-up.

Ascending aortic injuries following blunt trauma.

BACKGROUND: The diagnosis and the management of traumatic thoracic aortic injuries have undergone significant changes due to new technology and improved prehospital care. Most of the discussions have focused on descending aortic injuries. In this review, we discuss the recent management of ascending aortic injuries. METHODS: We found 5 cohort studies on traumatic aortic injuries and 11 case reports describing ascending aortic injuries between 1998 to the present through Medline research. RESULTS: Among case reports, 78.9% of cases were caused by motor vehicle accidents (MVA). 42.1% of patients underwent emergent open repair and the operative mortality was 12.5%. 36.8% underwent delayed repair. Associated injuries occurred in 84.2% of patients. Aortic valve injury was concurrent in 26.3% of patients. The incidence of ascending aortic injury ranged 1.9-20% in cohort studies. CONCLUSIONS: Traumatic injuries to the ascending aorta are relatively uncommon among survivors following blunt trauma. Aortography has been replaced by computed tomography and echocardiography as a diagnostic tool. Open repair, either emergent or delayed, remains the treatment of choice.

Moving mobile: using an open-sourced framework to enable a web-based health application on touch devices.

Computer devices using touch-enabled technology are becoming more prevalent today. The application of a touch screen high definition surgical monitor could allow not only high definition video from an endoscopic camera to be displayed, but also the display and interaction with relevant patient and health related data. However, this technology has not been quickly embraced by all health care organizations. Although traditional keyboard or mouse-based software programs may function flawlessly on a touch-based device, many are not practical due to the usage of small buttons, fonts and very complex menu systems. This paper describes an approach taken to overcome these problems. A real case study was used to demonstrate the novelty and efficiency of the proposed method.

A novel, minimally invasive access technique versus standard 18-gauge needle set for femoral access.

OBJECTIVE: To compare access site complications with the Micropuncture 21 gauge (G) needle set to the standard 18G needle in patients undergoing percutaneous coronary intervention (PCI) using the femoral approach. BACKGROUND: Vascular access site complications are the most common problems after PCI. The Micropuncture 21G needle set was recently introduced to minimize such complications. METHODS: A cohort of 3,243 consecutive patients was studied. Patients receiving thrombolytics, IIb/IIIa antagonist, coumadin, or intra-aortic balloon pump were excluded. Micropuncture access was used in 544 patients and standard 18G needle in 2,699. All access sites were managed with a vascular closure device. Primary endpoints included vascular perforation or limb ischemia requiring repair, retroperitoneal bleeding, pseudoaneurysm, arteriovenous fistula, and groin hematoma (>4 cm). RESULTS: Patients undergoing PCI with Micropuncture were at higher risk: they were older (65.9 ± 9 vs. 64.7 ± 11.8, P = 0.03); had lower body surface area (1.9 ± 0.2 vs. 2.0 ± 0.3, P = 0.02); more prevalent peripheral vascular disease [119 (21.9%) vs. 380 (14.1%), P < 0.001] and renal failure [106 (19.6%) vs. 318 (11.8%), P < 0.001]. Overall, there was no significant difference in the access site complications rate using Micropuncture vs. standard needle, 7 (1.3%) vs. 27 (1.0%), respectively, P = 0.54. The Micropuncture group had significantly higher retroperitoneal bleeding, 0.7% vs. 0.18%, P = 0.04. After multivariable adjustment, only age remained significantly associated with vascular complications (OR 1.03, P = 0.04). CONCLUSIONS: Femoral access using the Micropuncture technique did not reduce the incidence of vascular complications and the marginally higher than expected retroperitoneal bleeding is based on very small numbers. The routine use of the Micropuncture set and its technique should be revisited.

Impact of diabetes mellitus on long-term clinical outcomes of patients on chronic hemodialysis after percutaneous coronary intervention.

BACKGROUND: End-stage renal disease (ESRD) is known to correlate with poor outcome in patients undergoing percutaneous coronary intervention (PCI). This study examines the impact of diabetes mellitus (DM) on the long-term outcome of patients with ESRD on chronic hemodialysis. METHODS: A cohort of patients with ESRD on chronic hemodialysis, who underwent PCI with drug-eluting stents, was followed for 1 year. The clinical outcome in this population was compared retrospectively based on the presence of DM. Major adverse cardiac events (MACE) as the composite of all-cause death, Q-wave myocardial infarction and target lesion revascularization (TLR), as well as TLR as an individual outcome, were the main end points of the study. RESULTS: In the study cohort (n = 198), 48.5% had DM. Diabetic patients were more commonly female. The lesion characteristics were similar between groups except for more frequent saphenous vein graft intervention in nondiabetics. At 1-year follow-up there was no difference in the rate of MACE between diabetic and nondiabetic patients (40.4% vs. 39.3%, respectively, p = 0.89), driven primarily by a very high mortality rate (1-year overall mortality of 33.5%). After adjustment for the relevant clinical co-variables, DM was not associated with the composite end point. However, diabetic patients had a significantly higher incidence of 1-year TLR compared to nondiabetics (13.8% vs. 3.6%, respectively, p = 0.04). CONCLUSION: The prognosis of patients with ESRD after PCI is dismal with a very high overall mortality rate regardless of the presence of DM. Patients with ESRD appear to be at higher risk for the need of revascularization.

Utility of intravascular ultrasound guidance in patients undergoing percutaneous coronary intervention for type C lesions.

BACKGROUND: Percutaneous coronary intervention (PCI) of complex lesions (i.e., American College of Cardiology/American Heart Association class type C) remains challenging and the outcome may be compromised. The use of intravascular ultrasound (IVUS) to guide PCI was suggested to improve outcome. METHODS: A cohort of 1,984 patients who underwent PCI to type C lesions in our center from April 2000 to March 2010 was identified. Using propensity score matching with clinical and angiographic characteristics, we identified 637 patients who underwent IVUS guidance and 637 patients who had only angiographic guidance PCI. Major adverse cardiovascular events (MACE), a composite end-point of all-cause mortality, Q-wave myocardial infarction and target lesion revascularization, were compared between the 2 groups. RESULTS: After propensity score matching, baseline clinical and angiographic characteristics were well matched. Patients undergoing IVUS-guided PCI had less predilatation and more postdilatation, and were treated more often with cutting balloon. Final diameter stenosis was significantly smaller in the IVUS-guided group (3 ± 11% vs. 7 ± 19%, P < 0.001), resulting in higher angiographic success compared with the non-IVUS-guided group (97.9% vs. 94.8%, P < 0.001). The incidence of MACE was significantly lower in the IVUS-guided group compared to the angiography-guided group (11.0% vs. 15.6%, P = 0.017) as was cardiac death (1.9% vs. 4.4%, P = 0.010). CONCLUSION: IVUS-guided PCI for complex type C lesions is associated with better outcome and should be considered for these lesions.

Correlates and causes of death in patients with severe symptomatic aortic stenosis who are not eligible to participate in a clinical trial of transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation is currently being evaluated in patients with severe aortic stenosis who are considered high-risk surgical candidates. This study aimed to detect incidences, causes, and correlates of mortality in patients ineligible to participate in transcatheter aortic valve implantation studies. METHODS AND RESULTS: From April 2007 to July 2009, a cohort of 362 patients with severe aortic stenosis were screened and did not meet the inclusion/exclusion criteria necessary to participate in a transcatheter aortic valve implantation trial. These patients were classified into 2 groups: group 1 (medical): 274 (75.7%): 97 (35.4%) treated medically and 177 (64.6%) treated with balloon aortic valvuloplasty; and group 2 (surgical): 88 (24.3%). The medical/balloon aortic valvuloplasty group had significantly higher clinical risk compared with the surgical group, with significantly higher Society of Thoracic Surgeons score (12.8±7.0 versus 8.5±5.1; P<0.001) and logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) (42.4±22.8 versus 24.4±18.1; P<0.001). The medical/balloon aortic valvuloplasty group had a higher New York Heart Association functional class, incidence of renal failure, and lower ejection fraction. During median follow-up of 377.5 days, mortality in the medical/balloon aortic valvuloplasty group was 102 (37.2%), and during median follow-up of 386 days, mortality in the surgical group was 19 (21.5%). Multivariable adjustment analysis identified renal failure (hazard ratio [HR]: 5.60), New York Heart Association class IV (HR: 5.88), and aortic systolic pressure (HR: 0.99) as independent correlates for mortality in the medical group, whereas renal failure (HR: 7.45), Society of Thoracic Surgeons score (STS; HR: 1.09) and logistic EuroSCORE (HR: 1.45) were correlates of mortality in the in the surgical group. CONCLUSIONS: Patients with severe symptomatic aortic stenosis not included in transcatheter aortic valve implantation trials do poorly and have extremely high mortality rates, especially in nonsurgical groups, and loss of quality of life in surgical groups.

Comparison of closure strategies after balloon aortic valvuloplasty: suture mediated versus collagen based versus manual.

OBJECTIVES: To compare complication rates of a collagen-mediated closure device, suture-mediated closure technique and manual compression for access site management following balloon aortic valvuloplasty (BAV). BACKGROUND: Vascular complications, including perforation, limb ischemia, ateriovenous fistulas, and pseudoaneurysm, are a common source of morbidity in patients undergoing BAV with large bore femoral artery access. The available options for closure of the access site include manual compression, suture-mediated closure devices, and recently reported collagen-based closure devices. METHODS: The study cohort consisted of 333 patients with severe aortic stenosis undergoing BAV. Patients were divided into four groups according to access closure method: (1) Manual compression in 64 (19.2%); (2) Proglide 6 Fr in 162 (48.6%); (3) Angio-Seal 8 Fr in 89 (26.75%); and (4) Prostar 10 Fr in 18 (5.4%). RESULTS: There were no significant differences in baseline characteristics among the groups; although the Prostar group was had more males and the Angio-Seal group reported a lower incidence of renal failure and peripheral vascular disease. The Angio-Seal group had shorter procedural duration times compared with the other groups. In the Angio-Seal group (n = 47, 52.8%), a 10 Fr sheath size was primarily used to access the femoral artery, as compared with the manual compression and Proglide groups, which used a 12 Fr sheath in 29 (45.3%) and 66 patients (40.7%), respectively. A 13 Fr sheath was used in the Prostar group (n = 11, 61.1%), P < 0.001. The device failure rate was significantly higher in the Proglide group (n = 20, 12.3%) as compared with Angio-Seal (n = 3, 3.3%) and Prostar groups (n = 1, 5.5%), P = 0.03. Serious vascular complications requiring intervention were significantly higher in the manual compression group (n = 11, 17.1%) compared with the Proglide (n = 11, 6.7%), Angio-Seal (n = 5, 5.6%), and Prostar groups (n = 5, 1%), P < 0.001. The requirement for blood transfusion in the Angio-Seal group was significantly lower (n = 7, 7.8%) as compared with the manual compression (n = 20, 31.2%), Proglide (n = 35, 21.6%), and Prostar groups (n = 5, 27.7%), P < 0.001. CONCLUSION: In our case series, collagen-based closure devices and suture-mediated closure devices had fewer vascular complications than manual compression for hemostasis following BAV. Patient selection for collagen-based versus suture-mediated closure requires further study.

Decline in platelet count in patients treated by percutaneous coronary intervention: definition, incidence, prognostic importance, and predictive factors.

AIMS: We investigated the incidence, predictors, and prognostic impact of a decline in platelet count (DPC) in patients treated by percutaneous coronary intervention (PCI). METHODS AND RESULTS: A total of 10 146 consecutive patients treated by PCI from 2003 to 2006 were included. According to the magnitude of the DPC, the population was divided into four groups: no DPC (<10%), minor DPC (10-24%), moderate DPC (25-49%), and severe DPC (>or=50%). The primary haemorrhagic endpoint was a composite of post-procedure surgical repair major bleeding. The primary ischaemic endpoint was 30-day all-cause mortality-non-fatal myocardial infarction. Among the total population, 36% had a DPC <10%, 47.7% had a DPC of 10-24%, 14% had a DPC of 25-49%, and 2.3% had a DPC >or=50%. On multivariate analysis, moderate and severe DPC were independent predictive factors of the ischaemic outcome. Two procedural practices were identified that, if modified, might reduce the incidence of acquired thrombocytopaenia. Both the intraprocedural use of heparin (as opposed to bivalirudin) and of low molecular weight contrast material were independently associated with severe acquired thrombocytopaenia. CONCLUSION: Moderate and severe DPC are independent predictors of adverse bleeding and ischaemic outcomes in PCI. Adoption of intraprocedural anticoagulant other than heparin and avoidance of a low molecular weight contrast agent could potentially decrease the occurrence of severe acquired thrombocytopaenia.

Body mass index and bleeding complications after percutaneous coronary intervention: does bivalirudin make a difference?

BACKGROUND: The association between obesity and bleeding after percutaneous coronary intervention (PCI) is not well defined. We investigated the impact of body mass index (BMI) on PCI-related bleeding, and whether bivalirudin, compared to heparin, used as PCI anticoagulant modifies this relationship. METHODS: From 2000 to 2009, 16,783 patients who underwent PCI were grouped according to 6 BMI groups: underweight (<18.5 kg/m(2)), "normal" weight (18.5-24.9 kg/m(2)), overweight (25-29.9 kg/m(2)), class I (30-34.9 kg/m(2)), class II (35-39.9 kg/m(2)), and class III obesity (> or =40 kg/m(2)). Bivalirudin was used in 11,433 patients and heparin in 5,350. In-hospital major bleeding (hematocrit drop > or =15% or gastrointestinal bleeding) and need for transfusion rates were collected. RESULTS: The incidence of major bleeding varied significantly throughout the BMI spectrum (5.6% vs 2.5% vs 1.9% vs 1.6% vs 2.1% vs 1.9%, respectively, from underweight to class III obese patients, P < .001). The incidence of transfusion across BMI followed the same reverse J-shape curve (10.9% vs 6.6% vs 3.6% vs 3.4% vs 3.8% vs 5.6%, P < .001). After adjustment for potential confounding factors, underweight patients had neither an increased risk for major bleeding nor an increased risk for transfusion compared with "normal" weight patients. Class I obese patients had a lower risk of major bleeding (odds ratio [OR] 0.68 [95% CI 0.48-0.97]). Overweight, class I, and II obese patients had a lower risk of transfusion (respectively, OR 0.68 [0.55-0.84], 0.68 [0.53-0.87], and 0.66 [0.48-0.92]). The highest BMI patients had neither an increased risk for major bleeding (class II and III obesity) nor an increased risk for transfusion (class III obesity). The same reverse J-shaped relationship to BMI seen in the overall population for the raw incidence of major bleeding was found when the population was divided according to type of anticoagulant used as follows: bivalirudin or heparin. Likewise, the "need for transfusion" relationship to BMI is not altered by bivalirudin use. CONCLUSION: The better outcome for bleeding seen in patients in the middle of the BMI spectrum suggests the existence of a "bleeding obesity paradox," which persists after adjustment by confounding factors and exists irrespective of the anticoagulant used.

A further word of caution before using the internal mammary artery for coronary revascularization in patients with severe peripheral vascular disease!

OBJECTIVES: To characterize the clinical and angiographic characteristics of patients with collateralization from the internal mammary artery to the iliac artery. BACKGROUND: The use of the internal mammary arteries for coronary revascularization has become the standard of care in coronary artery bypass grafting (CABG). However, in patients with aortoiliac disease, the internal mammary arteries may become a major collateral route to the lower extremities. METHODS: A case series of 15 patients admitted for diagnostic coronary angiography were retrospectively identified, who were observed to have collateral flow from one or both internal mammary artery(ies) to an occluded or stenotic iliac artery. RESULTS: The mean age was 63.2 +/- 11.2 years; eight were men (53.3%). Coronary angiography was done as a perioperative evaluation for peripheral vascular surgery in three patients (20%) and was done because of cardiac symptoms or a positive thallium scan in 12 (80%). The finding that the mammary artery collateralized the iliac artery led to major treatment changes in all patients, seven (46.6%) who required CABG. In five patients (33%), use of one or both internal mammary artery(ies) for coronary grafts was avoided. CABG was deferred in one patient, whereas in another, percutaneous intervention in both iliac arteries preceded CABG using both mammary arteries. There was no incidence of postoperative acute lower extremity ischemia. CONCLUSIONS: Selective angiographic visualization of the internal mammary artery is an essential part of the preoperative evaluation in patients with severe peripheral vascular disease undergoing CABG.

Impact of intravascular ultrasound guidance in patients with acute myocardial infarction undergoing percutaneous coronary intervention.

OBJECTIVES: The aim of this study was to examine the utility of routine intravascular ultrasound (IVUS) guidance in patients with acute myocardial infarction (MI) undergoing percutaneous coronary intervention (PCI) with stent implantation. BACKGROUND: Stent thrombosis (ST) is a serious complication of PCI with stent implantation for patients presenting with acute MI. Mechanical factors such as incomplete stent expansion and smaller stent diameters are known to correlate with ST and restenosis. IVUS guidance for stent deployment is reported to reduce these events in stable patients. METHODS: We analyzed a cohort of 905 consecutive patients who underwent primary PCI for acute MI and were discharged alive. The clinical outcomes of 382 patients who underwent IVUS-guided PCI were compared to those of 523 patients who did not. Patients who presented with cardiogenic shock and rescue PCI were excluded. The primary composite endpoint of death, MI, and target lesion revascularization at 1-year follow-up was systematically indexed and a propensity score was performed with regard to the use of IVUS-guided PCI. RESULTS: Patients undergoing IVUS-guided PCI were older, more diabetic and hypertensive, but presented with less history of previous MI. The severity of coronary artery disease was balanced between both groups. The number of treated lesions and stents used was higher in the IVUS-guided group, with a longer procedural duration. The overall rates of the composite primary outcome were similar (14.5% vs. 14.3%, P = 0.94) as were the rates of definite and probable stent thrombosis at 1 year (2.1% vs. 2.1%, P = 0.99) in the IVUS-guided and no-IVUS groups, respectively. After multivariate and propensity score adjustment, IVUS guidance was not an independent predictor for the primary endpoint. CONCLUSION: This study does not support the routine use of IVUS guidance for stent deployment in patients who present with acute MI and undergo primary PCI.

Does on- versus off-hours presentation impact in-hospital outcomes of ST-segment elevation myocardial infarction patients transferred to a tertiary care center?

OBJECTIVES: To determine whether in-hospital outcome differs for transferred patients with ST-segment elevation myocardial infarction (STEMI) presenting during business (ON) hours vs. after (OFF) hours. BACKGROUND: Door-to-device (DTD) time is a prognostic factor in patients with STEMI and is longer during OFF hours. However, the in-hospital mortality is controversial. METHODS: This registry study included 786 consecutive patients with STEMI referred for primary percutaneous coronary intervention to a tertiary care center with an on-site cardiac catheterization team 24 hrs a day/7 days (24/7) a week. ON hours were defined as weekdays 8 a.m. to 5 p.m., while OFF hours were defined as all other times, including holidays. The primary outcomes were in-hospital death, reinfarction, and length of stay (LOS). RESULTS: ON hours (29.5%, n = 232) and OFF hours (70.5%, n = 554) groups had similar demographic and baseline characteristics. A significantly higher proportion of patients presenting ON hours had a DTD time ≤120 min compared to OFF hours patients (32.6% vs. 22.1%, P = 0.007). The rates of in-hospital death (8.2% vs. 6%), reinfarction (0% vs. 1.1%), and mean LOS (5.7 ± 6 vs. 5.7 ± 5) were not significantly different in the ON vs. OFF hours groups, all P = nonsignificant. CONCLUSION: In a tertiary care center with an on-site cardiac catheterization team 24/7, there are no differences in in-hospital outcomes of transferred patients with STEMI during ON vs. OFF hours.

Safety and efficacy of bivalirudin for percutaneous coronary intervention with rotational atherectomy.

BACKGROUND: Although bivalirudin use in percutaneous coronary intervention (PCI) results in less bleeding compared to unfractionated heparin (UFH) use, its safety in patients undergoing rotational atherectomy (RA) is unknown. METHODS: A cohort of 503 patients who underwent PCI with RA from 2000 to 2009 was studied. Patients receiving bivalirudin (n = 322) were compared to those (n = 181) treated with UFH +/- glycoprotein IIb/IIIa inhibitor (GPI) as PCI anticoagulation. Safety was assessed by the frequency of major bleeding (hematocrit drop > or =15%, intracerebral or gastro-intestinal bleeding) and need for transfusion. Efficacy was assessed by a composite end-point of in-hospital death, Q wave myocardial infarction (MI) or urgent coronary artery bypass graft (CABG). RESULTS: Those in the bivalirudin group were older, more hypertensive, and had greater body mass index. The UFH group was more likely to have prior MI, prior CABG, and an acute coronary syndrome at baseline. GPI was used in 93 patients (52%) of the UFH group. No difference was found between groups for the composite of death/Q wave MI/urgent CABG (1.9% vs. 1.7%, respectively, in bivalirudin vs. UFH group; P = 0.2). The frequency of major bleeding (2.2% vs. 1.7%; P = 0.8) or transfusion (5.6% vs. 8.7%; P = 0.9) was also similar between groups. After adjustment, bivalirudin use was not associated with a reduction in death/Q wave MI/urgent CABG, major bleeding, or transfusion compared to UFH. CONCLUSION: Bivalirudin use seems to be as safe and effective as UFH in patients undergoing RA.

Sirolimus-eluting stents versus paclitaxel-eluting stents in patients with chronic renal insufficiency.

BACKGROUND: Chronic renal insufficiency (CRI) is associated with an increased incidence of restenosis and stent thrombosis. Drug-eluting stents (DES), when compared to bare metal stents (BMS), reduce the incidence of restenosis in these patients. This study aimed to examine whether there are differences in clinical outcome after implantation of sirolimus-eluting stents (SES) versus paclitaxel-eluting stents (PES) in patients with CRI who are subjected to coronary intervention. METHODS: A cohort of 570 patients with CRI who underwent intervention with DES (346 with SES and 224 with PES) were followed clinically up to 1 year and the clinical events were recorded and compared between groups. RESULTS: Baseline and procedural characteristics were similar, with a slightly higher number of diseased vessels in the SES group as compared to the PES group (2.3 +/- 0.9 vs 2.1 +/- 0.9, P = 0.06). The overall rates of major adverse cardiac events (MACE) and stent thrombosis were similar. The PES group had lower revascularization rates when compared to the SES group. After covariate adjustment, however, there was no difference seen in target vessel revascularization between stent types (hazard ratio [HR]: 2.3 [0.8-6.2], P = 0.110). The strongest predictor of death and MACE at 1 year was the number of diseased vessels. CONCLUSIONS: Patients with CRI who undergo PCI with either SES or PES have similar repeat revascularization rates and acceptable stent thrombosis rates, although they continue to have high MACE and death rates.