Factors Influencing Provider and Patient Choice of P2Y12 Inhibitor Therapy.

BACKGROUND: Clopidogrel is the most commonly prescribed P2Y12 inhibitor for acute coronary syndrome (ACS) or stent placement, though ticagrelor or prasugrel may be preferred. Medication-related factors may influence selection of therapy. OBJECTIVES: To determine which factors most greatly influence cardiology-provider and patient selection of P2Y12 inhibitor to guide shared-decision making (SDM). METHODS: Single-center study assessed survey responses from 32 cardiology-providers who prescribed and 105 patients who received clopidogrel, prasugrel, or ticagrelor for ACS or stent placement. Respondents ranked factors influencing P2Y12 inhibitor selection and reported preference of therapy. Patients reported experience with shared decision-making process. RESULTS: Cardiology-providers ranked risk of bleeding, comfort/experience, and cost as most influential. Patients ranked risk of drug interaction, adverse effects, and reduction in myocardial infarction as most influential. Significant differences between cardiology-providers and patients were found for 5 of 8 factors. Cardiology-providers ranked once daily administration (p = 0.01), risk of bleeding (p = 0.002), and cost (p < 0.001) as more important than patients. Patients ranked risk of adverse effects (p = 0.007) and drug interactions (p = 0.005) as more important than cardiology-providers. Cardiology-providers prescribed ticagrelor 42.3% of the time following ACS, though 78.1% ranked it as their preferred agent. Patients were prescribed ticagrelor 9.3% of the time, though 55.7% ranked it as their preferred agent. Use of SDM was reported by 21.6% of patients and 88.5% were unaware that multiple P2Y12 inhibitors existed. CONCLUSION: Significant differences exist between cardiology-providers and patients regarding factors influencing P2Y12 inhibitor selection, specifically safety-related factors, once daily administration, and cost. Most patients were not involved in SDM.

The use of the AVERT system to limit contrast volume administration during peripheral angiography and intervention.

BACKGROUND: The AVERT(TM) Contrast Modulation System (AVERT) (Osprey Medical, MN) is designed to reduce contrast volume administration during angiography. The AVERT provides an adjustable resistance circuit which decreases the pressure head delivering contrast towards the patient. The AVERT has not been previously studied in patients undergoing peripheral digital subtraction angiography (DSA). The purpose of this study was (1) to evaluate contrast savings with the AVERT and (2) to evaluate the ability to generate clinically acceptable DSA images in the process. To better define the mechanism of action in the peripheral circulation, we also developed a bench model to study the effects of the AVERT on the hydrodynamics of contrast delivery. METHODS: Patients undergoing lower extremity DSA (diagnostic or intervention, sheath or catheter) were studied. The following variables were recorded for each injection: starting control syringe contrast volume, contrast volume injected towards patient, contrast volume returned to AVERT reservoir, net contrast administered to the patient and % savings. The AVERT resistance was adjusted manually based on operator's discretion--balancing image quality and contrast savings. RESULTS: About 408 DSA angiographic sequences were obtained in 22 patients undergoing 29 procedures. Almost 68% of the patients had chronic kidney disease. An 82% presented with critical limb ischemia, 18% had claudication. There was an overall 37% ± 14% savings of contrast (31% for diagnostic DSA, 40% for interventional procedures). Overall 91% of all images were acceptable for clinical decision making. Specifically, 94% of diagnostic and 87% of interventional images were acceptable. Injection through a 4 Fr catheter (77% acceptable) resulted in poorer image quality as compared to a 5 Fr catheter (96% acceptable). Image quality for 5, 6, and 7 Fr sheath injections was 86%, 91%, 98%, respectively. The bench model of peripheral angiography demonstrated a significant reduction in reflux of contrast proximal to the end of the catheter without loss of antegrade image quality - confirming the in vivo findings. CONCLUSIONS: We demonstrate that the use of the AVERT device during peripheral angiography results in significant contrast savings without compromising image quality.

Recanalization of popliteal and infrapopliteal chronic total occlusions using Viance and CrossBoss crossing catheters: a multicenter experience from the XLPAD Registry.

BACKGROUND: Chronic total occlusions (CTOs) are reported in up to 40% of patients with symptomatic peripheral arterial disease. The Viance Crossing catheter (Covidien) and the CrossBoss catheter (Boston Scientific) are novel devices that facilitate either true lumen or subintimal navigation across CTOs. The purpose of this study was to examine the acute procedural success of these devices for popliteal and below-the-knee (BTK) CTOs. METHODS: Clinical and procedural outcome data between Sept 2010 and October 2013 were analyzed from the ongoing multicenter XLPAD registry. Technical success was defined as true lumen passage of the catheter, while procedural success was defined as successful vessel revascularization inclusive of subintimal passage and reentry. RESULTS: Twenty-nine patients underwent 31 procedures, in which 37 lesions were treated with the Viance and CrossBoss catheters. Mean age of the group was 69.1 ± 10.7 years and 26 patients were male (90%). All patients (100%) had hypertension, 62% were diabetic, and 48% were active smokers. Critical limb ischemia was the indication for the procedure in 58% of cases; mean Rutherford class was 4.2 ± 1.2 for the entire cohort. Target CTOs included 14 anterior tibial, 9 posterior tibial, 5 peroneal, 1 tibio-peroneal trunk, and 8 popliteal artery lesions. Mean lesion length was 81 ± 64 mm; 15 lesions (41%) were severely calcified. True lumen passage was obtained in 24 lesions (65% technical success). Subintimal entry was achieved in 5 lesions (14%). Procedural success was achieved in 26 lesions (70%). Procedural failure was related to longer lesion length (P<.001), and mean length of failed lesions was 136 ± 65 mm. CONCLUSION: Viance and CrossBoss catheters were associated with an overall 70% procedural success with predominantly true lumen crossing in a BTK-CTO cohort. CTO length remains an important determinant of device success.

Impact of parallel micro-engineered stent grooves on endothelial cell migration, proliferation, and function: an in vivo correlation study of the healing response in the coronary swine model.

BACKGROUND: Stent luminal surface characteristics influence surface endothelialization. We hypothesize that luminal stent microgrooves created in the direction of coronary flow accelerate endothelial cell migration, resulting in lower levels of neointimal formation. METHODS AND RESULTS: Surface coverage efficiency was evaluated in vitro by allowing human aortic endothelial cells (HAEC) to migrate onto microgrooved (G) or smooth (NG) surfaces. HAEC functionality was assessed by proliferation rate, apoptosis rate, nitric oxide production, and inflammatory markers TNF-α and VCAM-1 expression. Early endothelialization and restenosis studies were performed using the porcine coronary injury model. Stainless steel stents of identical design with (GS) and without (NGS) luminal microgrooves were used. The commercially available Multi-Link Vision (MLVS) stent of identical design was used as a control. The degree of GS and NGS surface endothelialization was compared at 3 days. Biocompatibility and tissue response outcomes were evaluated at 28 days. The in vitro study demonstrated that at 7 days the presence of surface microgrooves increased HAEC migration distance >2-fold. Cell proliferation rate and nitric oxide production were increased and apoptosis rate was decreased. There was no difference in inflammatory marker expression. At 3 days, coronary artery stent endothelialization was significantly increased in GS compared with NGS (81.3% versus 67.5%, P=0.0002). At 28 days, GS exhibited lower neointimal thickness compared with either NGS (21.1%, P=0.011) or MLVS (40.8%, P=0.014). CONCLUSION: Parallel microgrooves on coronary stent luminal surfaces promote endothelial cell migration and positively influence endothelial cell function, resulting in decreased neointimal formation in the porcine coronary injury model.

Impact of 24-hr in-hospital interventional cardiology team on timeliness of reperfusion for ST-segment elevation myocardial infarction.

OBJECTIVE: We studied the effect of 24 hr a day, 7 days a week interventional cardiology staff on door-to-balloon (D2B) time and mortality in patients undergoing primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Any delay in PPCI in acute STEMI is associated with higher mortality and, therefore, time to treatment should be as short as possible. Despite the use of several strategies, goal D2B time of <90 min remains elusive. METHODS: The study examined 790 consecutive STEMI patients treated with PPCI as the reperfusion therapy of choice. Patients were grouped into a pre-24 x 7 and post-24 x 7 cohort to study the impact of the new protocol on D2B time and major adverse cardiovascular events (MACE) and mortality. RESULTS: Median D2B time decreased from 99 min in the pre-24 x 7 group to 55 min in the post-24 x 7 group (P = 0.001) and was not influenced by time of day or day of week. Adjusted for patient and clinical characteristics, the pre-24 x 7 group had increased in-hospital cardiovascular mortality (odds ratio 1.94, 95% confidence interval 0.95-3.94; P = 0.048) and MACE (odds ratio 1.66, 95% confidence interval 1.10-2.49; P = 0.009) compared with the post-24 x 7 group. Prolonged D2B time was also associated with higher 1-year overall mortality in the pre-24 x 7 group compared with the post-24 x 7 group (12.8% vs. 8.1%; hazard ratio 1.17, 95% confidence interval 1.04-2.66; P = 0.044). CONCLUSIONS: Round-the-clock, in-hospital interventional cardiology team consistently and significantly reduces D2B time, in-hospital cardiovascular mortality, MACE, and 1-year mortality in patients with STEMI.

Prophylactic use of manual thrombectomy in ST-segment elevation myocardial infarction.

OBJECTIVE: We sought to evaluate the effects of manual thrombectomy on myocardial reperfusion performed during percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Complete reperfusion after primary PCI is compromised by the presence of intraluminal thrombus. Thus effective and safe extraction of thrombus in a timely fashion is important for successful reperfusion. METHODS: Thirty-two patients (age 51+/-12 years, males 78%) with STEMI and angiographic evidence of intraluminal thrombus underwent thrombectomy during an 18-month period. Thrombectomy was performed after the presence of thrombus was confirmed angiographically by the operator either before or after primary angioplasty. Thrombectomy was performed using the 6F Export Aspiration Catheter (Medtronic Corporation, Santa Rosa, CA, USA). Myocardial reperfusion using Thrombolysis in Myocardial Infarction (TIMI) flow and myocardial blush grade was assessed by two independent observers. RESULTS: The infarct-related artery was left anterior descending (59%), right coronary artery (19%), saphenous venous graft (19%), or left circumflex artery (3%). The coronary lesion was Type B in 62% and Type C in 37% patients, with an average length of 18.2+4.6 mm and reference vessel diameter of 3.2+/-0.4 mm. The preprocedural TIMI flow was 0 in 62%, 1 in 12%, 2 in 22%, and 3 in 3% of patients. The postprocedural TIMI flow was 0 in 3%, 1 in 6%, 2 in 25%, and 3 in 56% of patients. The postprocedural myocardial blush grade was 0 in 6%, 1 in 9%, 2 in 35%, and 3 in 48% of patients. The in-hospital mortality was 0 and the 30-day mortality was 3%. CONCLUSION: Manual thrombectomy using an Export catheter is safe and effective in establishing myocardial reperfusion after STEMI.

Comparison of safety and efficacy of bivalirudin versus unfractionated heparin in percutaneous peripheral intervention: a single-center experience.

OBJECTIVES: The aim of this study was to determine the efficacy and safety of bivalirudin versus low-dose unfractionated heparin (UFH) in percutaneous peripheral intervention (PPI). BACKGROUND: Anticoagulation strategies used in PPI are based primarily on studies of percutaneous coronary intervention where higher doses of heparin are used usually in combination with a glycoprotein IIb/IIIa inhibitor. There are no studies comparing bivalirudin alone versus low-dose heparin in PPI. METHODS: Consecutive patients who underwent PPI at our institution were treated with either bivalirudin or low-dose UFH. Patients were assessed prospectively during index hospital stay for procedural success and bleeding complications. Of 236 patients, 111 were dosed with UFH at 50 U/kg (goal activated clotting time of 180 to 240 s), and 125 were dosed with bivalirudin at 0.75-mg/kg/h bolus followed by a 1.75-mg/kg infusion. Procedural success was defined as <20% post-procedure residual stenosis with no flow-limiting dissections or intravascular thrombus formation and major bleeding as intracranial or retroperitoneal hemorrhage or a fall in hemoglobin >or=5 g/dl. Anticoagulation cost analysis was conducted. RESULTS: Procedural success and major bleeding rates were similar with bivalirudin versus heparin (98% vs. 99% and 2.4% vs. 0.9%, respectively). There were no differences in minor bleeding, time to ambulation, and length of hospital stay. The hospital cost for bivalirudin was $547 and <$1.22 for heparin (10,000 U). Two activated clotting time levels cost $4.00. CONCLUSIONS: Low-dose UFH is as effective and safe as bivalirudin when used as an anticoagulation strategy in patients undergoing PPI, and low-dose UFH is less costly than bivalirudin. Larger randomized studies are required to further evaluate these findings.

Self-expanding intracoronary stent for symptomatic myocardial bridging.

Myocardial bridging has been recognized as a potential cause of symptoms of angina, arrhythmias and even infarction. Various treatment strategies including beta-blockers, surgery and more recently intra-coronary stents have been used to manage bridging. We report a novel case of use of self-expanding stent for myocardial bridging in a patient with symptoms of angina and ischemia on nuclear imaging. We further present the 18-month follow up showing minimal in-stent stenosis. To our knowledge, this is the first report of using a self-expanding stent in myocardial bridging. The use of self-expanding stents could be a potential treatment for symptomatic myocardial bridging.

Is primary hyperaldosteronism a risk factor for aortic dissection?

Primary hyperaldosteronism is a rare (<1%) and underdiagnosed cause of secondary hypertension. We present a case of aortic dissection in a patient with primary hyperaldosteronism. To our knowledge, there are six other reported cases of aortic dissection in patients with primary hyperaldosteronism. Our case strengthens the hypothesis that primary hyperaldosteronism is a potential independent risk factor for aortic dissection.

Specific temporal profile of matrix metalloproteinase release occurs in patients after myocardial infarction: relation to left ventricular remodeling.

BACKGROUND: Changes in matrix metalloproteinase (MMP) and tissue inhibitors of MMPs (TIMPs) contribute to left ventricular (LV) remodeling after myocardial infarction (MI). We tested the hypothesis that a specific plasma MMP/TIMP profile would emerge after MI and be associated with the degree of LV dilation. METHODS AND RESULTS: LV end-diastolic volume and MMP/TIMP plasma profiles were determined in 53 age-matched control subjects and 32 post-MI patients from day 1 through 180 after MI. LV end-diastolic volume increased by > 38% at day 90 after MI (P < 0.05). MMP-9 increased by > 150% from control at day 1 after MI (P < 0.05) and remained elevated. MMP-8 rose to > 120% at day 3 after MI (P < 0.05) and fell to control values by day 5. TIMP-1 increased by > 60% from control at day 1 after MI (P < 0.05), whereas TIMP-2 increased only at later time points. Cardiac-specific TIMP-4 fell by 40% at day 5 after MI and remained reduced. A persistent or elevated MMP-9 at day 5 was accompanied by a 3-fold end-diastolic volume increase at day 28 (P < 0.05). CONCLUSIONS: A specific temporal pattern of MMP/TIMPs occurred in post-MI patients that included an early and robust rise in MMP-9 and MMP-8 and a uniform fall in TIMP-4. These findings suggest that a specific MMP/TIMP plasma profile occurs after MI and holds both prognostic and diagnostic significance.

Matrix metalloproteinases/tissue inhibitors of metalloproteinases: relationship between changes in proteolytic determinants of matrix composition and structural, functional, and clinical manifestations of hypertensive heart disease.

BACKGROUND: Chronic hypertension may cause left ventricular (LV) remodeling, alterations in cardiac function, and the development of chronic heart failure (CHF). Changes in the composition of the extracellular matrix (ECM) known to occur in hypertension are believed to be causally related to these structural, functional, and clinical outcomes. However, whether the determinants of ECM composition, such as the balance between ECM proteases (matrix metalloproteinases [MMPs]) and their tissue inhibitors [TIMPs]), are altered in hypertensive heart disease is unknown. METHODS AND RESULTS: Plasma MMP-2, -9, and -13 values, TIMP-1 and -2 values, and Doppler echocardiography images were obtained for 103 subjects divided into 4 groups: (1) reference subjects (CTL) with no evidence of cardiovascular disease, (2) hypertensive (HTN) subjects with controlled blood pressure and no LV hypertrophy, (3) hypertensive subjects with controlled blood pressure and with LV hypertrophy (HTN+LVH) but no CHF, and (4) hypertensive subjects with controlled blood pressure, LVH, and CHF (HTN+LVH+CHF). Compared with CTL, patients with HTN had no significant changes in any MMP or TIMP. Patients with HTN+LVH had decreased MMP-2 and MMP-13 values and increased MMP-9 values. Only patients with HTN+LVH+CHF had increased TIMP-1 values. A TIMP-1 level >1200 ng/mL was predictive of CHF. CONCLUSIONS: Patients with hypertension but normal LV structure and function had normal MMP/TIMP profiles. Changes in MMP profiles that favor decreased ECM degradation were associated with LVH and diastolic dysfunction. An increased TIMP-1 level predicted the presence of CHF. Although these findings should be confirmed in a larger prospective study, these data do suggest that changes in the MMP/TIMP balance may play an important role in the structural, functional, and clinical manifestations of hypertensive heart disease.

Use of extracorporeal membrane oxygenation in a patient with diffuse alveolar hemorrhage.

Extracorporeal membrane oxygenation (ECMO) was developed as a supportive therapy for severe respiratory failure. It has been shown to be life-saving in neonates and children with isolated respiratory failure, however, its usefulness in adults remains controversial. We report the successful use of ECMO in an adult patient with severe hypoxemic respiratory failure secondary to diffuse alveolar hemorrhage from Wegener granulomatosis.