Abnormal left atrial body stiffness is predicted by appendage size: impact of appendage occlusion on left atrial mechanics assessed by pressure-volume analysis.

Atrial cardiomyopathy has been recognized as having important consequences for cardiac performance and clinical outcomes. The pathophysiological role of the left atrial (LA) appendage and the effect of percutaneous left atrial appendage occlusion (LAAO) upon LA mechanics is incompletely understood. We evaluated if changes in LA stiffness due to endocardial LAAO can be detected by LA pressure-volume (PV) analysis and whether stiffness parameters are associated with baseline characteristics. Patients undergoing percutaneous endocardial LAAO (n = 25) were studied using a novel PV analysis using near-simultaneous three-dimensional LA volume measurements by transesophageal echocardiography (TEE) and direct invasive LA pressure measurements. LA stiffness (dP/dV, change in pressure with change in volume) was calculated before and after LAAO. Overall LA stiffness significantly increased after LAAO compared with baseline (median, 0.41-0.64 mmHg/mL; P ≪ 0.001). LA body stiffness after LAAO correlated with baseline LA appendage size by indexed maximum depth (Spearman's rank correlation coefficient Rs = 0.61; P < 0.01). LA stiffness change showed an even stronger correlation with baseline LA appendage size by indexed maximum depth (Rs = 0.70; P < 0.001). We found that overall LA stiffness increases after endocardial LAAO. Baseline LA appendage size correlates with the magnitude of increase and LA body stiffness. These findings document alteration of LA mechanics after endocardial LAAO and suggest that the LA appendage modulates overall LA compliance.NEW & NOTEWORTHY Our study documents a correlation of LA appendage remodeling with the degree of chronically abnormal LA body stiffness. In addition, we found that LA appendage size was the baseline parameter that best correlated with the magnitude of a further increase in overall LA stiffness after appendage occlusion. These findings offer insights about the LA appendage and LA mechanics that are relevant to patients at risk for adverse atrial remodeling, especially candidates for LA appendage occlusion.

Comparison of devices used in carotid artery stenting: A vascular quality initiative analysis of commonly used carotid stents and embolic protection devices.

BACKGROUND: Data regarding efficacy of various stent and embolic protection device (EPD) combinations to prevent stroke during carotid artery stenting (CAS) is limited. We compared post-procedure inpatient neurologic outcomes across various carotid stent-EPD platforms recorded in the Vascular Quality Initiative (VQI) registry. METHODS: We analyzed 13,786 consecutive CAS procedures in the VQI registry performed between January 1, 2005 and December 31, 2015. The most commonly used stent-EPD combinations (n = 5407) were included in the analysis. Post-procedure inpatient neurologic outcomes included (1) ipsilateral stroke/transient ischemic attack (TIA) and (2) any stroke/TIA. Multivariate generalized estimating equation regression analysis was performed, adjusting for age, sex, tobacco use, coronary artery disease, congestive heart failure, prior stroke/TIA, hypertension, history of carotid revascularization, and presence of a second ipsilateral stenosis >70%, to determine whether risk of outcomes differed according to device. RESULTS: Of 13,786 CAS procedures, Xact-Emboshield (n = 2,438, 17.6%), Precise-Angioguard (n = 1,480, 10.7%), Acculink-Accunet (n = 829, 6.01%), and Acculink-Emboshield (n = 660, 4.8%) were the most commonly used combinations, accounting for a total of 5,407 procedures. Inpatient event rates for ipsilateral stroke/TIA and any stroke/TIA were 1.9 and 2.7% in the Accunet-Acculink, 3.0 and 3.2% in Acculink-Emboshield, 3.2 and 4.1% in Precise-Angioguard and 2.2 and 3.0% in Xact-Emboshield. There was no evidence of difference in risk of ipsilateral stroke/TIA or any stroke/TIA across device combinations (P = 0.15 and P = 0.16, respectively). CONCLUSION: CAS with current carotid stent-EPD combinations is associated with low rates of inpatient stroke/TIA. There is no statistically significant difference in rates of inpatient stroke/TIA across device combinations.

Use of regadenoson for measurement of fractional flow reserve.

OBJECTIVE: To compare the use of regadenoson to adenosine for measurement of fractional flow reserve (FFR). BACKGROUND: FFR is an accepted method to assess the functional significance of intermediate coronary artery stenoses and uses adenosine to induce maximal hyperemia. The use of the selective A2a receptor agonist regadenoson for FFR is not established. METHODS: Fifty-seven patients undergoing clinically indicated FFR assessment of intermediate coronary stenoses were included. For the initial assessment of FFR, hyperemia was achieved by a standard intravenous adenosine infusion (140 mcg/kg/min). After a washout period of 10 min, FFR was reassessed using regadenoson as a single 0.4 mg intravenous bolus. FFR measurements were recorded at baseline and following maximal hyperemia with both agents. RESULTS: Mean age was 57 ± 8 years and 47 were male. Sixty coronary lesions were evaluated and were located in the left anterior descending in 34, the left circumflex in 9, right coronary in 15, and left main coronary artery in 2. Mean ( ± SD) FFR following adenosine and regadenoson was 0.79 ( ± 0.09) and 0.79 (±0.09), respectively, P = NS. Time to FFR nadir was shorter with regadenoson compared to adenosine, 36.6 ± 24 versus 66 ± 0.19 sec, P < 0.0001, respectively. No patients experienced any significant side effects related to regadenoson. CONCLUSIONS: Regadenoson is a viable alternative to intravenous adenosine for achieving maximal hyperemia during FFR assessment. Compared to adenosine, regadenoson has a similar hemodynamic response, achieves more rapid hyperemia, is easier to use, and has an excellent side-effect profile.

Detecting elevated left ventricular end diastolic pressure from simultaneously measured femoral pressure waveform and electrocardiogram.

Objective.Instantaneous, non-invasive evaluation of left ventricular end-diastolic pressure (LVEDP) would have significant value in the diagnosis and treatment of heart failure. A new approach called cardiac triangle mapping (CTM) has been recently proposed, which can provide a non-invasive estimate of LVEDP. We hypothesized that a hybrid machine-learning (ML) method based on CTM can instantaneously identify an elevated LVEDP using simultaneously measured femoral pressure waveform and electrocardiogram (ECG).Approach.We studied 46 patients (Age: 39-90 (66.4 ± 9.9), BMI: 20.2-36.8 (27.6 ± 4.1), 12 females) scheduled for clinical left heart catheterizations or coronary angiograms at University of Southern California Keck Medical Center. Exclusion criteria included severe mitral/aortic valve disease; severe carotid stenosis; aortic abnormalities; ventricular paced rhythm; left bundle branch and anterior fascicular blocks; interventricular conduction delay; and atrial fibrillation. Invasive LVEDP and pressure waveforms at the iliac bifurcation were measured using transducer-tipped Millar catheters with simultaneous ECG. LVEDP range was 9.3-40.5 mmHg. LVEDP = 18 mmHg was used as cutoff. Random forest (RF) classifiers were trained using data from 36 patients and blindly tested on 10 patients.Main results.Our proposed ML classifier models accurately predict true LVEDP classes using appropriate physics-based features, where the most accurate demonstrates 100.0% (elevated) and 80.0% (normal) success in predicting true LVEDP classes on blind data.Significance.We demonstrated that physics-based ML models can instantaneously classify LVEDP using information from femoral waveforms and ECGs. Although an invasive validation, the required ML inputs can be potentially obtained non-invasively.

Instantaneous detection of acute myocardial infarction and ischaemia from a single carotid pressure waveform in rats.

Aims: Myocardial infarction (MI) is one of the leading causes of death worldwide. It is well accepted that early diagnosis followed by early reperfusion therapy significantly increases the MI survival. Diagnosis of acute MI is traditionally based on the presence of chest pain and electrocardiogram (ECG) criteria. However, around 50% of the MIs are without chest pain, and ECG is neither completely specific nor definitive. Therefore, there is an unmet need for methods that allow detection of acute MI or ischaemia without using ECG. Our hypothesis is that a hybrid physics-based machine learning (ML) method can detect the occurrence of acute MI or ischaemia from a single carotid pressure waveform. Methods and results: We used a standard occlusion/reperfusion rat model. Physics-based ML classifiers were developed using intrinsic frequency parameters extracted from carotid pressure waveforms. ML models were trained, validated, and generalized using data from 32 rats. The final ML models were tested on an external stratified blind dataset from additional 13 rats. When tested on blind data, the best ML model showed specificity = 0.92 and sensitivity = 0.92 for detecting acute MI. The best model's specificity and sensitivity for ischaemia detection were 0.85 and 0.92, respectively. Conclusion: We demonstrated that a hybrid physics-based ML approach can detect the occurrence of acute MI and ischaemia from carotid pressure waveform in rats. Since carotid pressure waveforms can be measured non-invasively, this proof-of-concept pre-clinical study can potentially be expanded in future studies for non-invasive detection of MI or myocardial ischaemia.

The addition of evolocumab to maximal tolerated statin therapy improves walking performance in patients with peripheral arterial disease and intermittent claudication (Evol-PAD study).

OBJECTIVE: To test the hypothesis that in patients with peripheral arterial disease (PAD) and claudication, treated with maximal tolerated statin therapy, the addition of a monthly subcutaneous injection of evolocumab for 6 months improves treadmill walking performance. BACKGROUND: Lipid lowering therapy improves walking parameters in patients with PAD and claudication. Evolocumab decreases cardiac and limb adverse events in patients with PAD; however, the effect of evolocumab on walking performance is not known. METHODS: We performed a double-blind, randomized, placebo-controlled study to compare maximal walking time (MWT) and pain free walking time (PFWT) in patients with PAD and claudication treated with monthly subcutaneous injections of evolocumab 420 mg (n = 35) or placebo (n = 35). We also performed measurements of lower limb perfusion, brachial flow mediated dilatation (FMD), carotid intima media thickness (IMT), and serum biomarkers of PAD disease severity. RESULTS: After six-months of treatment with evolocumab MWT increased by 37.7 % (87.5 ± 24 s) compared to 1.4 % (-21.7 ± 22.9 s) in the placebo group, p = 0.01. PFWT increased by 55.3 % (67.3 ± 21.2 s) in the evolocumab group compared to 20.3 % (8.5 ± 20.3 s) in the placebo group, p = 0.051. There was no difference in lower extremity arterial perfusion measurements. FMD increased by 42.0 ± 73.9 % (1.01 ± 0.7 %) in the evolocumab group and decreased by 16.29 ± 20.06 % (0.99 ± 0.68 %) in the placebo group (p < 0.001). IMT decreased by 7.16 ± 4.6 % (0.06 ± 0.04 mm) in the evolocumab group and increased by 6.68 ± 4.9 % (0.05 ± 0.03 mm) in the placebo group, (p < 0.001). CONCLUSIONS: The addition of evolocumab to maximal tolerated statin therapy improves maximal walking time in patients with PAD and claudication, increases FMD, and decreases IMT. CONDENSED ABSTRACT: Peripheral arterial disease (PAD) impairs quality of life by causing lower extremity intermittent claudication, rest pain, or amputation. Evolocumab is a monthly injectable monoclonal antibody medication that reduces cholesterol. In this study, we randomly treated patients with PAD and claudication, and on background statin therapy, with evolocumab or placebo, and found that evolocumab improves walking performance on a treadmill test by increasing maximal walking time. We also found that evolocumab decreases plasma MRP-14 levels, a marker of PAD severity.

Devices to treat peripheral chronic total occlusions.

Chronic total occlusions occur in approximately 40% of patients with peripheral vascular disease and are a difficult lesion subset to treat by endovascular approaches. The challenge lies in the difficulty in placing a wire across the site of occlusion and remaining in an intraluminal position. Conventional percutaneous transluminal balloon angioplasty for chronic total occlusions involves advancing a stiff wire through the site of obstruction, has the chance for vessel dissection and perforation, and is associated with high rates of procedural failure. Several mechanical devices have thus been developed to treat peripheral chronic total occlusions. In this article, we provide a review of the currently available devices that may increase the procedural success of treating peripheral chronic total occlusions.

Factors Associated With the Use of Bare Metal Stents in Patients With ST Elevation Myocardial Infarction.

BACKGROUND: Drug eluting stents (DES) are used in the majority of patients undergoing percutaneous coronary intervention (PCI). Factors associated with the use of bare metal stents (BMS) for patients undergoing primary PCI for ST elevation myocardial infarction (STEMI) have not been adequately explored. The objective of this study was to evaluate factors associated with BMS use in STEMI patients undergoing primary PCI. METHODS: Patients undergoing primary PCI for STEMI between January 2008 and February 2015 were retrospectively identified. Patients who received both a DES and BMS were included in the DES group and patients receiving balloon angioplasty only were excluded. Baseline demographics, angiographic variables, procedure related variables and in-hospital events were collected. Multivariate analysis was performed to identify factors associated with BMS use. RESULTS: Eight hundred and sixty-five patients underwent primary PCI for STEMI during the study period. Seventy-two patients (8.3%) received balloon angioplasty only and were excluded, yielding 793 patients for the study cohort. Three hundred fifty-two patients (44%) received BMS and 441 patients (56%) received DES. Patients receiving DES had a higher prevalence of diabetes mellitus, prior myocardial infarction, prior PCI, left anterior descending artery culprit location and Medicaid Insurance compared to those receiving BMS. Patients receiving BMS had a higher prevalence of cardiogenic shock and right coronary artery culprit location. Unadjusted in-hospital mortality was significantly higher for patients receiving BMS compared to patients receiving DES, 11.1% vs 3.2%, respectively, p < 0.0001. Multivariate predictors of BMS use were cardiogenic shock (OR 30.3; 95% CI 11.25 to 81.73) and diabetes mellitus (OR 2.99; 95% CI 1.04 to 8.64). CONCLUSION: In a contemporary series of patients undergoing primary PCI for STEMI, BMS were used in 44% of patients and independent factors associated with BMS use were cardiogenic shock and diabetes mellitus.

Intrinsic frequency method for instantaneous assessment of left ventricular-arterial coupling after transcatheter aortic valve replacement.

BACKGROUND: Aortic stenosis (AS) is the most common cause for valve replacement in the United States. The pathophysiology of AS involves obstruction to the left ventricular (LV) outflow and reduced arterial compliance. The intrinsic frequency (IF) method is a system-based approach for hemodynamic monitoring of the LV-arterial system and involves determination of ω1 and ω2, which represent the dynamics of LV systolic and vascular function, respectively. Total frequency variation of the systemic circulation is the difference between these IFs (Δω = ω1- ω2). OBJECTIVE: Our goal in this study was to investigate whether Δω, obtained from the ascending aortic pressure waveform, can be indicative of LV-arterial coupling after transcatheter aortic valve replacement (TAVR). APPROACH: Thirty patients undergoing elective TAVR for severe, symptomatic AS were included. We applied the IF method to assess the immediate effects of TAVR on LV-arterial coupling. MAIN RESULTS: Mean age was 86 ± 4 years, 50% were male with a mean aortic valve area of 0.7 cm2 and mean ejection fraction (EF) of 59 ± 7%. The results showed a significant decrease in Δω (47.6 to 9.5 bpm, p < 0.00001) and a significant increase in ω2 (51.9 to 84.6 bpm, p < 0.00001) immediately post TAVR. SIGNIFICANCE: These preliminary findings indicate that the IF method can be used to evaluate improvements in LV hemodynamics immediately following TAVR. Use of the IF method may have implications for patients undergoing TAVR with impaired LV systolic function.

Incidence and treatment of severe primary mitral regurgitation in contemporary clinical practice.

BACKGROUND: Mitral regurgitation (MR) is a common valvular disorder, occurring in up to 10% of the general population. Although surgery is the established treatment for primary MR, many patients do not receive appropriate therapy. The objective of this study was to determine the incidence and treatment pattern of patients with severe MR evaluated at a tertiary medical center and determine factors associated with receiving surgery. METHODS: All patients with moderate-severe and severe MR undergoing transthoracic echocardiography from 2011 to 2016 were identified. Patients with prior mitral valve surgery were excluded. Treatment recommendations were classified as referral to cardiology, referral to cardiothoracic surgery (CTS), receiving mitral valve surgery or receiving MitraClip. A multivariate logistic regression model was used to evaluate factors associated with referral to CTS or receiving surgery. RESULTS: During the study period, 1918 transthoracic echocardiogram were performed and 412 patients with moderate-severe or severe MR were identified. One hundred sixty-six patients (40%) had primary MR and 246 patients (60%) had secondary MR. For those with primary MR, 75 patients (45%) received treatment (surgery, n = 60 and MitraClip, n = 15) and 91 patients (55%) did not receive treatment. One hundred patients (60%) were referred to CTS and 128 patients (77%) were referred to cardiology. Patients undergoing surgery were younger (62.6 ±â€¯14.2 years vs 72.0 ±â€¯14 years, p < 0.001), with a higher prevalence of heart failure (57% vs 40%, p = 0.044) and a lower prevalence of stroke (3% vs 24%, p < 0.001) and hypertension (54% vs 74%, p = 0.012), compared to patients not undergoing surgery, respectively. Ejection fraction (60.4 ±â€¯10.9% vs 56.3 ±â€¯11.6%, p = 0.034), left ventricular end diastolic diameter (53.2 ±â€¯10.3 mm vs 48.7 ±â€¯10.9 mm, p = 0.040) and effective regurgitant orifice area (0.5 ±â€¯0.4 cm2 vs 0.3 ±â€¯0.1 cm2) were higher in patients undergoing surgery, compared to patients not undergoing surgery, respectively. The most common reason for not receiving surgery was that MR was not addressed by the treating physician and lost to clinical follow-up. Over 50% of patients that did not receive surgery had at least 1 indication based upon current practice guidelines. CONCLUSIONS: In contemporary clinical practice, less than half of patients with moderate-severe and severe primary MR received surgery and many were not referred for surgical consultation.

Use of the STEMI Team for Treatment of Patients With Pulmonary Embolism: A Pilot Study.

BACKGROUND: Patients with massive and submassive pulmonary embolism (PE) require rapid identification, triage, and consideration for reperfusion therapy. Use of an existing ST-segment elevation myocardial infarction (STEMI) team and activation protocol may be an effective means to care for these patients. OBJECTIVE: The objective of this analysis was to evaluate a pilot study using the STEMI team and a dedicated PE protocol for treatment of patients with massive and submassive PE. METHODS: From June 2014 to April 2016, a total of 40 patients with massive and submassive PE were evaluated. Baseline demographics, mode of hospital entry (transfer-in, in-hospital, and emergency department [ED] arrival), treatment time intervals (door to computed tomography PE protocol [CTPE], CTPE to invasive pulmonary angiogram, door to treatment time), procedures performed, and in-hospital clinical events were collected. RESULTS: Mean age was 56 ± 14 years, 17 (42%) were male, and 12 (30%) had a prior history of deep venous thrombosis or PE. Twenty-three patients (57%) had massive PE and 17 patients (43%) had submassive PE. Mode of hospital entry was transfer-in (38%), in-hospital (20%), and ED arrival (42%). Four patients (10%) presented with cardiac arrest, 8 patients (20%) required intubation, and 5 patients (12%) required extracorporeal membrane oxygenation. Ten patients (25%) received anticoagulation therapy or placement of inferior vena cava filter, 3 patients (7.5%) received diagnostic pulmonary angiography alone, and 27 patients (67.5%) received endovascular treatment. For patients arriving via the ED, door to CTPE was 4.9 ± 3.6 hours, CTPE to diagnostic pulmonary angiography was 7.8 ± 8.5 hours, and door to treatment time was 10.2 ± 9.0 hours. Endovascular devices utilized included combinations of rheolytic and other thrombectomy devices as well as catheter-directed fibrinolysis. Length of hospital stay was 15 ± 15 days and in-hospital survival rate was 90%. CONCLUSIONS: Use of an existing STEMI team and activation protocol is a feasible method to care for patients with massive and submassive PE. This pilot study demonstrated rapid treatment times with low in-hospital mortality.

Comparison of Outcomes of Percutaneous Coronary Intervention on Native Coronary Arteries Versus on Saphenous Venous Aorta Coronary Conduits in Patients With Low Left Ventricular Ejection Fraction and Impella Device Implantation Achieved or Attempted (from the PROTECT II Randomized Trial and the cVAD Registry).

Patients with prior coronary artery bypass grafting (CABG) represent a high-risk cohort given associated medical conditions and worse outcome of saphenous vein graft compared with native vessel percutaneous coronary intervention (PCI). The goal of the current analysis was to compare clinical outcomes in 591 patients with and without prior CABG and multivessel coronary artery disease or unprotected left main disease and severely reduced left ventricular systolic function underwent Impella supported PCI from the PROTECT II randomized trial and the cVAD Registry. Patients with prior CABG surgery (n = 201) were compared with those without prior CABG surgery (n = 390). The primary end point of this analysis was overall mortality at 30 days. Patients with prior CABG surgery had greater Society of Thoracic Surgery mortality score compared with patients without prior CABG surgery, 7.6 ± 6.4 versus 5.1 ± 5.5, respectively, p <0.001. Saphenous vein graft PCI was performed in 17% of patients with prior CABG surgery. Number of vessels treated was lower in patients with prior CABG surgery compared with patients without prior CABG surgery, 1.66 ± 0.56 versus 1.89 ± 0.64, respectively, p <0.001. Achievement of TIMI 3 flow post PCI and overall PCI success was similar in the two groups. Overall mortality at 30 days was similar in patients with prior CABG surgery compared with patients without prior CABG surgery, 6.75% versus 6.61%, respectively, p = 1.0. In conclusion, in this high-risk cohort of patients underwent hemodynamically supported PCI, prior CABG surgery was not associated with worse outcome. The use of hemodynamic support appears to mitigate the increased risk of PCI associated with prior CABG.

Long-term outcomes of drug-eluting stents versus bare metal stents in saphenous vein graft interventions. Evidence from a meta-analysis of randomized controlled trials.

BACKGROUND: The optimal stent for use in saphenous vein graft (SVG) intervention is still debatable. Multiple randomized trials have compared drug-eluting stents (DES) to bare metal stents (BMS) in SVG interventions with conflicting results. METHODS: Authors searched the online databases for randomized controlled trials (RCTs) comparing DES to BMS in SVG percutaneous coronary interventions (PCI). We performed a meta-analysis using a random effects model to calculate the odds ratio for outcomes of interest. RESULTS: Authors studied six RCTs that included 1592 patients undergoing PCI of SVG. The mean follow up was 42 months. Patients mean age was the same in both groups: 70.3 years in the DES group (approximately 93.3% male) and 70.3 years in the BMS group (approximately 93.8% male). Vein graft age was 13.4 years in the DES PCI arm vs. 13.4 years in the BMS PCI arm. Four of the six trials reported data on embolic protection device use: 67% (303/452) in the DES arm vs. 67.9% (309/455) in the BMS arm. The primary outcome of long-term all-cause mortality was not different between DES vs. BMS (15.2% vs. 14.1%, OR 1.12, 95% CI 0.67-1.88; P = 0.66). Secondary outcomes were also similar between DES and BMS: major adverse cardiovascular events (31.6% vs. 33.1%, OR 0.79, 95% CI 0.45-1.38; P = 0.41); cardiac death (9% vs. 8.6%, OR 1.12, 95% CI 0.55-2.30; P = 0.75); myocardial infarction (8% vs. 9.5%, OR 0.84, 95% CI 0.47-1.51; P = 0.57); target lesion revascularization (16.4% vs. 14.4%, OR 0.98, 95% CI 0.50-1.92; P = 0.95); and target vessel revascularization (19% vs. 19.4%, OR 0.75, 95% CI 0.41-1.34; P = 0.33). CONCLUSION: At a mean follow-up of 42 months, no difference was observed in clinical outcomes between DES and BMS in SVG interventions.

Prevalence of high on-treatment (aspirin and clopidogrel) platelet reactivity in patients with critical limb ischemia.

OBJECTIVES: The goal of this study is to establish the prevalence of high on-treatment platelet reactivity to aspirin (HPRA) and clopidogrel (HPRC) in patients with critical limb ischemia (CLI). BACKGROUND: CLI is associated with an increased risk of death and cardiovascular events. Unlike other patient populations with atherosclerotic cardiovascular disease, previous studies failed to demonstrate a benefit of antiplatelet therapy in patients with CLI. METHODS: From June 2014 to November 2016, we performed platelet reactivity studies for P2Y12 and thromboxane A2 (TXA2) inhibition in 100 CLI patients receiving daily treatment with aspirin and clopidogrel. P2Y12 inhibition was measured by two assays: vasodilator-stimulated phosphoprotein (VASP) and VerifyNow P2Y12 assays. HPRC was defined as VerifyNow P2Y12 reactive units (PRU) >208 and VASP-platelet reactivity index (VASP-PRI) >50%. TXA2 inhibition was measured with the VerifyNow aspirin test and HPRA was defined as aspirin reaction units (ARU) >550. RESULTS: Mean age was 67±11 years, 50% were male, 80% had diabetes mellitus, and 26% had chronic renal insufficiency. Thirty-three percent of patients had a PRU >208 and 46% a VASP-PRI >50%. HPRC was present in 26% of patients based on the criteria of both a PRU >208 and VASP-PRI >50%. HPRA was present in 25% of patients. The overall prevalence of HPR to ASA or clopidogrel was 35% and HPR to both drugs was present in 8% of patients. Clinical characteristics were similar between groups. CONCLUSIONS: HPR to aspirin or clopidogrel is highly prevalent in patients with CLI. Nearly one in ten patients with CLI is a hyporesponder to both aspirin and clopidogrel.

Switch to Ticagrelor in critical limb ischemia antiplatelet study (STT-CLIPS).

OBJECTIVE: To investigate platelet reactivity in patients with critical limb ischemia (CLI) after switching from clopidogrel to ticagrelor. BACKGROUND: High on-treatment platelet reactivity (HPR) is highly prevalent in patients with CLI treated with clopidogrel. The effect of ticagrelor in patients with CLI is not known, however. METHODS: We performed P2Y12 platelet receptor inhibition studies (VASP and VerifyNow) in 50 patients with CLI. Tests were performed before and 6±1h after daily 75mg clopidogrel dose. Patients were then switched to ticagrelor 90mg twice daily for two weeks and platelet assays repeated. Patients were divided based on VerifyNow P2Y12 reaction units (PRU). Group 1: HPR defined as PRU ≥208 and Group 2: Appropriate platelet inhibition (API), PRU <208. RESULTS: After two weeks of uninterrupted antiplatelet therapy, mean PRU results were 173 PRU and 71 PRU at baseline (p<0.0001) and 140 PRU and 63 PRU after 6h (p<0.0001) for clopidogrel and ticagrelor, respectively. Before daily clopidogrel dose, 36% of patients (n=18) demonstrated HPR and after 6h, 30% (n=15). One patient (2%) had HPR on ticagrelor. Ninety-four percent of patients with HPR on clopidogrel demonstrated appropriate platelet inhibition after switching to ticagrelor and all patients with API on clopidogrel remained with API after switching to ticagrelor. Six hours after daily dosing, VASP-PRI >50% was found in 42% of clopidogrel and 2% of ticagrelor treated patients. CONCLUSIONS: Among patients with CLI, ticagrelor achieved greater platelet inhibition than clopidogrel during maintenance treatment and at 6h after daily dosing. High on-treatment platelet reactivity to clopidogrel in patients with CLI can be overcome by switching to ticagrelor.

Percutaneous left atrial appendage transcatheter occlusion (PLAATO system) to prevent stroke in high-risk patients with non-rheumatic atrial fibrillation: results from the international multi-center feasibility trials.

OBJECTIVES: These studies were conducted to evaluate the feasibility of percutaneous left atrial appendage (LAA) occlusion using the PLAATO system (ev3 Inc., Plymouth, Minnesota). BACKGROUND: Patients with atrial fibrillation (AF) have a five-fold increased risk for stroke. Other studies have shown that more than 90% of atrial thrombi in patients with non-rheumatic AF originate in the LAA. Transvenous closure of the LAA is a new approach in preventing embolism in these patients. METHODS: Within two prospective, multi-center trials, LAA occlusion was attempted in 111 patients (age 71 +/- 9 years). All patients had a contraindication for anticoagulation therapy and at least one additional risk factor for stroke. The primary end point was incidence of major adverse events (MAEs), a composite of stroke, cardiac or neurological death, myocardial infarction, and requirement for procedure-related cardiovascular surgery within the first month. RESULTS: Implantation was successful in 108 of 111 patients (97.3%, 95% confidence interval [CI] 92.3% to 99.4%) who underwent 113 procedures. One patient (0.9%, 95% CI 0.02% to 4.9%) experienced two MAEs within the first 30 days: need for cardiovascular surgery and in-hospital neurological death. Three other patients underwent in-hospital pericardiocentesis due to a hemopericardium. Average follow-up was 9.8 months. Two patients experienced stroke. No migration or mobile thrombus was noted on transesophageal echocardiogram at one and six months after device implantation. CONCLUSIONS: Closing the LAA using the PLAATO system is feasible and can be performed at acceptable risk. It may become an alternative in patients with AF and a contraindication for lifelong anticoagulation treatment.

Impact of Surgical Consultation on Outcomes in Hemodynamically Supported High-Risk Percutaneous Coronary Intervention: Insights From PROTECT II Randomized Study.

BACKGROUND: In observational studies of patients undergoing percutaneous coronary intervention (PCI), surgical ineligibility is associated with increased mortality. Whether the use of hemodynamic support during PCI can mitigate the adverse prognostic importance of surgical ineligibility is unknown. METHODS AND RESULTS: We sought to evaluate the association between request for surgical consultation (presumed surgical ineligibility) prior to PCI and clinical outcomes in 427 patients with multivessel coronary artery disease or unprotected left main disease and severely reduced left ventricular systolic function undergoing PCI assisted by hemodynamic support (intraaortic balloon pump or Impella) from the PROTECT II randomized trial. Patients in whom surgical consultation was requested prior to PCI (n = 201) were compared with those in whom surgical consultation was not requested (n = 226). The primary endpoint of this analysis was the composite of 90-day major adverse cardiac and cerebrovascular events (MACCE). Demographic and procedural variables were similar between patients receiving surgical consultation and patients not receiving surgical consultation, with the exception that the prevalence of prior coronary artery bypass graft surgery was significantly higher in patients not receiving surgical consultation (42.0% vs 25.4%; P<.001); these patients also had a higher proportion of lesions within a saphenous vein graft, and a greater prevalence of moderate/severe vessel calcification. MACCE rate at 90 days was similar in patients receiving surgical consultation compared with patients not receiving surgical consultation (23.4% vs 29.0%, respectively; P=.19). CONCLUSIONS: In this high-risk cohort of patients undergoing hemodynamically supported PCI, clinical outcome was not associated with an antecedent request for surgical consultation (presumed surgical ineligibility). Whether the use of hemodynamically supported PCI can lessen the risk conferred by surgical ineligibility requires further study.

Association of elevated triglycerides and acute myocardial infarction in young Hispanics.

BACKGROUND: Previous studies have demonstrated that acute myocardial infarction (AMI) in young patients (age <45years) is associated with a high prevalence of smoking, obesity, hyperlipidemia and single vessel coronary artery disease (CAD). Hispanics represent the largest growing ethnic minority in the United States, yet features of AMI in young Hispanics have not been described. METHODS: Patients undergoing percutaneous coronary intervention for AMI at Los Angeles County + University of Southern California Medical Center and Keck Medical Center were studied. We compared young Hispanics (age<45, n=47) with older patients (Hispanics and non-Hispanics age ≥45, n=888) to identify unique features of AMI in young Hispanics. We also compared young Hispanics with young non-Hispanics (n=33) and older Hispanics (n=447) in regards to traditional CAD risk factors, laboratory values and in-hospital outcomes. Multivariable logistic regression was performed to identify variables independently associated with in-hospital mortality. RESULTS: Young Hispanics had higher triglyceride levels than young non-Hispanics and older patients (234.5±221.0mg/dL vs. 145.3±67.4mg/dL vs. 156±118.2mg/dL, p<0.0004); and higher triglyceride than older Hispanics (234.5±221.0 vs. 147.0±98.9mg/dL, p<0.02). Body mass index was independently associated with the logarithm (base10) of triglyceride levels (p<0.0001). Hispanic ethnicity and age<45years, however, were not independently associated with in-hospital mortality. CONCLUSIONS: Young Hispanics with AMI have higher triglyceride levels than young non-Hispanics and older Hispanics. The elevated triglyceride levels may be related to lifestyle changes experienced by a young immigrant population transitioning to life in the United States.

Same-day discharge after coronary stenting and femoral artery device closure: A randomized study in stable and low-risk acute coronary syndrome patients.

OBJECTIVE: To compare same-day (SD) vs. delayed hospital discharge (DD) after single and multivessel coronary stenting facilitated by femoral closure device in patients with stable angina and low-risk acute coronary syndrome (ACS). METHODS: University of Southern California patients were screened and coronary stenting was performed in 2480 patients. Four hundred ninety-three patients met screening criteria and consented. Four hours after percutaneous coronary intervention, 100 were randomized to SD (n=50) or DD (n=50). Patients were followed for one year; outcomes-, patient satisfaction-, and cost analyses were performed. RESULTS: Groups were well distributed, with similar baseline demographic and angiographic characteristics. Mean age was 58.1±8.8years and 86% were male. Non-ST-elevation myocardial infarction and unstable angina were the clinical presentations in 30% and 44% of the SD and DD groups, respectively (p=0.2). Multivessel stenting was performed in 36% and 30% of SD and DD groups, respectively (p=0.14). At one year, two patients from each group (4%) required unplanned revascularization and one patient in the SD group had a gastrointestinal bleed that required a blood transfusion. Six SD and four DD patients required repeat hospitalization (p=0.74). There were no femoral artery vascular complications in either group. Patient satisfaction scores were equivalent. SD discharge was associated with $1200 savings per patient. CONCLUSIONS: SD discharge after uncomplicated single and multivessel coronary stenting of patients with stable, low-risk ACS, via the femoral approach facilitated by a closure device, is associated with similar clinical outcomes, patient satisfaction, and cost savings compared to overnight (DD) hospital stay.

Contemporary use of balloon aortic valvuloplasty in the era of transcatheter aortic valve implantation.

The development of transcatheter aortic valve implantation (TAVI) has increased the use of balloon aortic valvuloplasty (BAV) in treating aortic stenosis. We evaluated our use of BAV in an academic tertiary referral center with a developing TAVI program. We reviewed 69 consecutive stand-alone BAV procedures that were performed in 62 patients (mean age, 77 ± 10 yr; 62% men; baseline mean New York Heart Association functional class, 3 ± 1) from January 2009 through December 2012. Enrollment for the CoreValve(®) clinical trial began in January 2011. We divided the study cohort into 2 distinct periods, defined as pre-TAVI (2009-2010) and TAVI (2011-2012). We reviewed clinical, hemodynamic, and follow-up data, calculating each BAV procedure as a separate case. Stand-alone BAV use increased 145% from the pre-TAVI period to the TAVI period. The mean aortic gradient reduction was 13 ± 10 mmHg. Patients were successfully bridged as intended to cardiac or noncardiac surgery in 100% of instances and to TAVI in 60%. Five patients stabilized with BAV subsequently underwent surgical aortic valve replacement with no operative deaths. The overall in-hospital mortality rate (17.4%) was highest in emergent patients (61%). The implementation of a TAVI program was associated with a significant change in BAV volumes and indications. Balloon aortic valvuloplasty can successfully bridge patients to surgery or TAVI, although least successfully in patients nearer death. As TAVI expands to more centers and higher-risk patient groups, BAV might become integral to collaborative treatment decisions by surgeons and interventional cardiologists.