Role of contractile reserve as a predictor of mortality in low-flow, low-gradient severe aortic stenosis following transcatheter aortic valve replacement.

OBJECTIVES: The aim of this study was to determine the prognostic value of contractile reserve (CR) at baseline in patients with low-flow, low-gradient severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Patients with severe AS, left ventricular dysfunction, and low transaortic gradient are at high risk for mortality during surgical aortic valve replacement (SAVR). Furthermore, patients without CR have been shown to have perioperative mortality comparable to that of patients treated medically for severe AS. METHODS: We retrospectively analyzed patients who underwent TAVR with a diagnosis of low-gradient severe AS (mean transvalvular aortic gradient < 40 mmHg, LVEF < 50%, and AVA ≤ 1.0 cm2 or AVAi ≤ 0.6 cm2 ) and who had a pre-TAVR dobutamine stress echocardiogram (DSE). Patients were stratified by the presence or absence of CR, defined as an increase in stroke volume ≥ 20% during DSE. RESULTS: From 2008 to 2016, 61 patients with low-gradient severe AS underwent TAVR and had pre-TAVR DSE. CR was present in 31 patients (51%) and absent in 30 (49%). There was no significant difference between the two groups in baseline demographics, medical history, access site, or types of valves. All-cause mortality was similar in both groups at 30 days (13% with CR vs 10% without CR, P = 1.00) and 1 year (29% with CR vs 33% without CR, HR 1.20, 95% CI 0.49-2.96, P = 0.69). CONCLUSION: In patients with low-flow, low-gradient severe AS undergoing TAVR, the presence or absence of CR does not predict all-cause mortality at 30 days or 1 year.

Temporal trends in patient referral for Transcatheter aortic valve replacement and reasons for exclusion at a high-volume Center in the United States.

BACKGROUND: Clinical indications for transcatheter aortic valve replacement (TAVR) and elements of the implantation procedure, including delivery system miniaturization and novel access options, have evolved over time. The reasons patients are excluded from TAVR also have changed. The impact of these changes on patient referral for and exclusion from TAVR is unknown. METHODS: We retrospectively analyzed patients referred to our center for TAVR from January 2010 to August 2016 to evaluate reasons for patient exclusion. Patients were divided into three groups based on initial screening date for trends in demographics and exclusion: Group 1, 2010-2012; Group 2, 2012-2014; Group 3, 2014 to August 1, 2016. Annual trends for patient exclusion from TAVR were assessed. RESULTS: One thousand nine hundred fifty-three patients were referred and underwent screening for TAVR. The rates at which patients were referred for TAVR were 23.8, 25.9, and 24.5 per month in groups 1, 2, and 3, respectively. Rate of patient exclusion from TAVR decreased from 68% in Group 1 to 38% in Group 3 (P < .001). The largest percentage of patients (29.4%) were initially excluded from TAVR for cardiac reasons, but this trend has decreased over time. Twenty-five percent are excluded for lack of procedural indication. Exclusion from TAVR for vascular access reasons decreased from 7.9% in 2010 to 1.0% in 2016 (P = .017). CONCLUSIONS: Referral numbers have been robust since TAVR became available. The percentage of patients excluded from TAVR has decreased over time. Patients are most commonly excluded from TAVR for concomitant coronary artery disease (CAD), asymptomatic severe AS, moderate AS, or non-cardiac critical illness. Patients with CAD and those with asymptomatic severe AS or moderate AS should be a focus for continued research in TAVR.

Utility of an additive frailty tests index score for mortality risk assessment following transcatheter aortic valve replacement.

BACKGROUND: The impact of frailty assessment on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) remains unclear. Our aim was to evaluate the individual effect of each frailty test and the utility of an additive frailty index score on short- and long-term survival following TAVR. METHODS: Retrospective analysis of consecutive TAVR patients for whom a complete set of frailty tests was obtained: algorithm defined grip strength and 5-m walking tests, body mass index <20 kg/m2, Katz activities of daily living ≤4/6, serum albumin <3.5 g/dL. Frailty status was defined as having 3 or more positive frailty tests. Included were 498 patients with a mean age of 82±8 years. RESULTS: Frailty status, observed in 266 (53%) patients, was associated with both 30-day and 1-year mortality (6% vs. 2%, P=.016; 20% vs. 9%, P<.001; within the respective frailty groups). As compared to 0-2 frailty criteria, a higher frailty index score was associated with increased risk of death at 1 year (OR 2.23; 95% CI 1.14-4.34; P=.019 and OR 3.30; 95% CI 1.36-8.00; P=.008 for 3 and 4-5 frailty criteria met, respectively). In Cox regression analysis, frailty status was correlated with 1-year mortality (HR=2.2; 95%CI 1.25-3.96; P=.007), and a higher frailty index was associated with increased mortality risk (HR=2.0; 95% CI 1.08-3.7; P=.027; and HR=3.07; 95% CI 1.4-6.7; P=.005; for any 3, and 4-5 frailty criteria, respectively). CONCLUSIONS: Frailty status and a higher frailty index score were associated with increased 1-year mortality risk following TAVR.

Impact of Left Ventricular Outflow Tract Calcification on Outcomes Following Transcatheter Aortic Valve Replacement.

BACKGROUND: We aimed to determine left ventricular outflow tract (LVOT) calcification impact following transcatheter aortic valve replacement (TAVR) with contemporary transcatheter heart valves. Recent studies reported a higher rate of 2-year mortality with greater than moderate LVOT calcium, but they have not established a reliable and validated method to assess the degree of valve calcification and utilized first-generation valves for their analyses. MATERIALS/METHODS: We conducted a retrospective analysis of patients who underwent TAVR at our institution from 2013 through 2017 with available valves. LVOT calcification quantification was assessed as a continuous variable. RESULTS: We included 273 patients: 179 had a non-calcified LVOT (NOLVOTCA) and 96 had a calcified LVOT (LVOTCA). Balloon post-dilatation (BPD) was utilized in 31.3% of LVOTCA vs. 19% of NOLVOTCA (p = 0.029). The Evolut R valve was used in 40.6% vs. 23.4% (p = 0.002), while the Sapien 3 was used in 59.4% vs. 76.6% (p = 0.004), for the LVOTCA and NOLVOTCA, respectively. Paravalvular leak (PVL) at hospital discharge was higher in LVOTCA (47.5%) versus NOLVOTCA (29.1%; p = 0.004). All-cause mortality (11.5% vs. 10.1%; p = 0.5) and need for permanent pacemaker implantation were similar between the groups. There was a positive trend between LVOT calcification volume and the probability of any PVL (OR 1.012; 95% CI, 0.99-1.02). CONCLUSIONS: TAVR performed in patients with calcified LVOT is safe, but LVOT calcification adversely impacts TAVR outcomes, with a higher PVL rate despite greater usage of BPD. Calcium quantification did not predict any PVL degree post-TAVR.

Combined Vascular Brachytherapy and Stenting for the Treatment of In-Stent Restenosis.

In-stent restenosis (ISR) remains a therapeutic challenge in the current drug-eluting stent (DES) era. Vascular brachytherapy (VBT) is a therapeutic option for ISR, but data about the outcomes of combination therapy with VBT and stenting for ISR lesions are sparse. We retrospectively analyzed patients who presented with ISR at our institution from 2003 through 2017. Three treatment arms were compared: VBT alone, VBT plus bare-metal stent (BMS), and VBT plus DES. Clinical, procedural, and 1-year outcome data were collected. Follow-up was obtained by phone calls and clinic visits. The patient cohort included 461 patients (764 ISR lesions). Of these, 333 patients (533 lesions) were treated with VBT alone, 89 patients (158 lesions) with VBT plus BMS, and 39 patients (73 lesions) with VBT plus DES. There were no significant differences in baseline characteristics among the 3 groups except for more patients with a remote smoking history in the VBT plus BMS (43.8%) and VBT plus DES groups (56.4%), and more patients with history of peripheral vascular disease (39.5%) and congestive heart failure (27%) in the VBT plus DES group. The most common clinical presentation was unstable angina (64.6%). In the VBT plus DES group, 10.3% of patients presented with MI, versus 5.5% in the VBT alone group and 2.2% in the VBT plus BMS group. At 1-year follow-up, the VBT plus DES group had higher rates of target vessel revascularization-major adverse cardiovascular events (38.5%) than the VBT plus BMS (21.3%) and VBT alone (15.6%) groups (p = 0.002). In conclusion, in patients with ISR, combination therapy with VBT and stenting at the same setup is associated with worse outcomes at 12 months and, if possible, should be avoided.

Overview of the 2018 US Food and Drug Administration Circulatory System Devices Panel meeting on the INCRAFT AAA Stent Graft System.

On June 12, 2018, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to advise on the safety and effectiveness of the INCRAFT® AAA Stent Graft System for the treatment of abdominal aortic aneurysms (AAA) and to consider a premarket approval application sponsored by Cordis, Inc., for Unique identifier: NCT01664078 based on the results of the pivotal INSPIRATION trial (URL: https://clinicaltrials.gov/ct2/show/NCT01664078). The INCRAFT® AAA Stent Graft System is designed for endovascular repair of infrarenal AAAs with complex aortic anatomies. The stent-graft system utilizes nitinol stent and polyester graft technology in an ultra-low profile delivery system, with the goal of isolating the aneurysmal sac and preventing sac rupture. The multicenter, prospective, non-randomized investigation trial met its primary composite safety and effectiveness endpoints but also showed higher-than-anticipated rates of stent fracture and endoleaks. The committee discussion focused on how these events impact the long-term safety and effectiveness, as well as the benefit/risk profile, of the device. While the panel acknowledged the risk of the device, the panel's final vote supported that the benefits of the INCRAFT AAA Stent Graft System outweigh the risks and that a post-marketing study should be mandated. The FDA approved the device for use in complex access anatomies in December 2018.

Coronary perfusion pressure and left ventricular hemodynamics as predictors of cardiovascular collapse following percutaneous coronary intervention.

BACKGROUND/PURPOSE: Appropriate patient selection for mechanical circulatory support following percutaneous coronary intervention (PCI) remains a challenge. This study aims to evaluate the role of coronary perfusion pressure and other left ventricular hemodynamics to predict cardiovascular collapse following PCI. METHODS/MATERIALS: We retrospectively analyzed all patients who underwent PCI for acute coronary syndrome (ACS) from 2003 to 2016. Coronary perfusion pressure was calculated for each patient and defined as the difference in mean arterial pressure and left ventricular end diastolic pressure (LVEDP). Logistic regression analysis was performed to determine predictor of composite outcome of in-hospital mortality, myocardial infarction (MI), congestive heart failure (CHF), and cardiogenic shock. RESULTS: Nine hundred twenty-two patients were analyzed. Two-hundred twenty-eight (25%) presented with ST-elevation MI (STEMI) while 694 (75%) underwent PCI for unstable angina or non-Q-wave MI. The mean LVEDP was significantly higher in the STEMI patients (24 ±â€¯9 vs. 19 ±â€¯8 mm Hg, p < 0.05) and perfusion pressure significantly lower (68 ±â€¯24 vs. 74 ±â€¯18 mm Hg, p < 0.05). Eighty-seven (9.4%) reached the composite endpoint, and there was no difference between the STEMI and Not-STEMI groups. Neither LVEDP nor coronary perfusion pressure was a predictor of the composite outcome following multivariable logistic regression analysis for either STEMI or Not-STEMI patients. Increasing age, chronic renal insufficiency (CRI), CHF, and low left ventricular ejection fraction were predictors of the composite outcome for Not-STEMI patients, whereas only history of cerebrovascular accident and CRI were predictors for STEMI patients. CONCLUSIONS: In hemodynamically stable patients presenting with ACS, LVEDP and coronary perfusion pressure are not predictive of in-hospital cardiovascular collapse. SUMMARY: The authors retrospectively analyzed 922 patients from a single center who underwent percutaneous coronary intervention (PCI) for acute coronary syndromes to evaluate the role of coronary perfusion pressure and other left ventricular hemodynamics to predict cardiovascular collapse following PCI. They found that neither coronary perfusion pressure nor left ventricular end diastolic pressure was predictive of in-hospital cardiovascular collapse.

Genetic and Nongenetic Implications of Racial Variation in Response to Antiplatelet Therapy.

Race has been identified as an independent risk factor for poor prognosis and an independent predictor of survival in coronary artery disease. Race-related dissimilarities have been identified in cardiovascular patients in terms of age of presentation, co-morbidities, socioeconomic status, and treatment approach as well as genetically driven race-related disparities in responsiveness to medications. Antiplatelet therapy represents a fundamental component of therapy in cardiovascular patients, especially in patients presenting with acute coronary syndromes. It has been argued that the different level of platelet reactivity and varying response to antiplatelet therapy among races may account in part for worse outcomes in certain populations. The purpose of this review is to describe genotypic and phenotypic race-related differences in platelet reactivity and responsiveness to cardiovascular treatment, focusing on antiplatelet therapy to highlight the need establish a more effective and targeted antithrombotic strategy.

Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis and Prior External Chest Radiation.

BACKGROUND/PURPOSE: Surgical aortic valve replacement (SAVR) in patients with symptomatic severe aortic stenosis (AS) and prior chest radiation is associated with poor outcomes in comparison with patients without prior radiation. Our objective was to compare clinical outcomes of patients with and without prior chest radiation undergoing transcatheter aortic valve replacement (TAVR) for symptomatic severe AS. METHODS/MATERIALS: Between January 2003 and January 2017, 1150 patients underwent TAVR at our institution. Of these, 44 had prior chest radiation. Baseline demographic and clinical characteristics, procedural details, and clinical outcomes were prospectively collected. RESULTS: Patients with prior chest radiation were younger, 76 ±â€¯13 years, compared with those without prior chest radiation, 82 ±â€¯8 years (p = 0.002). Median Society of Thoracic Surgeons score for chest radiation patients was 7 ±â€¯4, compared to 8 ±â€¯5 in those without prior radiation. Despite higher prevalence of complete heart block, there was no significant difference between the 2 groups with regard to the need for permanent pacemaker implantation. There was a trend toward longer length of intensive care unit stay in chest radiation patients, but there was no significant difference in 30-day or 1-year mortality. CONCLUSIONS: Thus, TAVR appears to be a safe treatment option in the short and medium term for patients with symptomatic severe AS and prior chest radiation.

Echogenic liposome compositions for increased retention of ultrasound reflectivity at physiologic temperature.

Targetable echogenic liposomes (ELIP) for ultrasound enhancement of atheroma have recently been developed; however, their retention of echogenicity at physiological temperature is less than desirable. The purpose of this study was to improve ELIP stability and increase clinical potential. The approach utilized the original procedures but involved manipulation of the lipid composition by reducing the level of unsaturation of the phospholipids components to minimize the rate of loss of echogenicity. Echogenicity was measured using a 20 MHz intravascular ultrasound (IVUS) catheter and quantified (as mean gray scale values) using computer-assisted videodensitometry. The optimal preparation for retention of echogenicity stability at physiologic temperature was egg phosphatidylcholine/dipalmitoylphosphatidylcholine/dipalmitoylphos-phatidylethanolamine/dipalmitoylphosphatidylglycerol/cholesterol (27:42:8:8:15, molar percent). This preparation retained 51 +/- 3.5% of its echogenicity after 1 h at 37 degrees C, more than 5x that retained by the previously descried preparation. In this composition nearly 2/3 of the phosphosphatidylcholine is fully saturated. Such an increase in saturation is anticipated to stiffen the lipid acyl chains. The air pockets that are responsible for reflection of ultrasound waves can be assumed to be stabilized by a lipid monolayer at the interface between the air and bulk water. The increased rigidity of that monolayer is presumed to be responsible for reducing the loss of air and extending the duration of echogenic activity. The stability of this improved formulation now appears to be more than adequate for clinical applications.

Bioprosthesis leaflet thrombosis following self-expanding valve-in-valve transcatheter aortic valve replacement in patient taking factor Xa inhibitor and warfarin: A case report.

An 87-year-old female with symptomatic severe aortic stenosis underwent transcatheter valve replacement (TAVR) via the transfemoral approach with a 29mm self-expanding device. Moderate to severe paravalvular regurgitation led to the development of congestive heart failure and hospital readmission 1 month following TAVR. A second 29mm valve was placed to abolish the paravalvular regurgitation. Routine follow-up computed tomography (CT) imaging demonstrated leaflet thickening and decreased leaflet mobility suggesting valve thrombosis, despite adherence to Factor Xa inhibitor. Transthoracic echocardiogram revealed normal transaortic valve gradients. The patient was transitioned to a vitamin K antagonist and repeat imaging 3months later demonstrated progression of thrombosis to an additional leaflet. The case illustrates the potential increased risk of leaflet thrombosis in patients receiving valve-in-valve TAVR procedures, the superiority of multidetector computed tomography to image subclinical leaflet thrombosis, and highlights the need for further investigation in this area.

Successful transcatheter aortic valve replacement in an oversized 800 mm2 annulus and bicuspid aortic valve.

The current iterations of balloon-expandable transcatheter aortic valve replacement (TAVR) valves consist of a maximum size of 29 mm, corresponding to maximum annulus area of 680 mm2. However, a number of patients who qualify for TAVR based on surgical risk may have anatomical features outside the FDA-approved descriptions. The technique of overexpansion of TAVR valves during deployment allows for more patients to be treated successfully. This particular case demonstrates that overexpansion is safe and efficacious in a very large annulus of >800 mm2. Careful planning and consideration of aortic root calcification is helpful for technique of overexpansion and, ultimately, the technique may increase the number of patients eligible for TAVR.

Meta-Analysis of the Impact of Strut Thickness on Outcomes in Patients With Drug-Eluting Stents in a Coronary Artery.

The aim of this network meta-analysis is to assess the impact of strut thickness on clinical outcomes in patients who underwent percutaneous coronary intervention. We searched Medline/PubMed and performed a Bayesian network meta-analysis to compare outcomes of patients who underwent percutaneous coronary intervention with drug-eluting stents (DES) of different strut thicknesses (ultrathin 60 to 80 µm; thin 81 to 100 µm; intermediate 101 to 120 µm; thick ≥120 µm). Studies comparing DES with similar strut thickness, bare metal stents, and fully bioresorbable scaffolds were excluded. Odds ratios with credible intervals (OR [CrIs]) were generated with random-effects models to compare outcomes. Our primary end point was stent thrombosis (ST). We identified 69 RCTs including 80,885 patients (ultrathin group = 10,219; thin group = 36,575; intermediate group = 11,399; thick group = 22,692). Mean age was 64 ± 11 years and 75% were male gender. When compared with thick-strut DES, ultrathin struts had significant less ST and myocardial infarction (OR 0.43 [CrI 0.27 to 0.68]; and OR 0.73 [CrI 0.62 to 0.92], respectively). Sensitivity analysis including only studies with permanent polymer DES gave similar results. Improvement in DES technology with thinner struts is associated with significant reduction in ST and myocardial infarction compared with thicker struts.

Emergent valve-in-valve transcatheter aortic valve replacement in patient with acute aortic regurgitation and cardiogenic shock with preoperative extracorporeal membrane oxygenator: A case report and review of the literature.

We describe a challenging case of successful use of emergent veno-arterial extracorporeal membrane oxygenation and valve-in-valve transcatheter aortic valve implantation with a Sapien S3 valve.

Clinical Frailty as an Outcome Predictor After Transcatheter Aortic Valve Implantation.

Society of Thoracic Surgeons (STS) score and frailty index are calculated routinely as part of transcatheter aortic valve implantation (TAVI) assessment to determine procedure risk. We aim to evaluate the incremental improvement of STS risk score using frailty status in predicting short- and long-term outcome after TAVI. Study population included 544 consecutive TAVI patients who completed full frailty assessment and STS score calculation before the procedure. Frailty is defined by the presence of any 3 of the following 5 criteria: algorithm-defined grip strength and 15-foot walking tests, body mass index < 20 kg/m2, Katz activity of daily living ≤ 4/6, serum albumin < 3.5 g/dl. Multivariable logistic analysis of 30-day and 1-year mortality was performed using a logistic regression model that comprised the STS risk score model as a single variable. Based on frailty definition, 242 patients were frail and 302 patients were not. STS score was higher in the frail group than in the nonfrail group. Compared with STS risk score alone, frailty status was a significant predictor of 1-year mortality after TAVI procedure (odds ratio 1.0, 95% confidence interval [CI] 1.0 to 1.1, p = 0.029 vs 2.75, 95% CI 1.55 to 4.87, p <0.001, respectively). Although the c-statistic of the 1-year STS risk prediction model only changed from 0.62 to 0.66 (p = 0.08), the net reclassification improvement increased significantly to 52.8% after adding frailty to the prediction model (95% CI 0.28 to 0.77, p <0.0001). Frailty status is associated with higher mortality in TAVI cohort and incrementally improves the well-validated STS risk prediction model. Frailty assessment should continue to be part of the preprocedural assessment to further improve patient outcomes after TAVI.

Antiplatelet and anticoagulation regimen in patients with mechanical valve undergoing PCI - State-of-the-art review.

A common clinical dilemma regarding treatment of patients with a mechanical valve is the need for concomitant antiplatelet therapy for a variety of reasons, referred to as triple therapy. Triple therapy is when a patient is prescribed aspirin, a P2Y12 antagonist, and an oral anticoagulant. Based on the totality of the available evidence, best practice in 2017 for patients with mechanical valves undergoing percutaneous coronary intervention (PCI) is unclear. Furthermore, the optimal duration of dual antiplatelet therapy after PCI is evolving. With better valve designs that are less thrombogenic, the thromboembolic risks can be reduced at a lower international normalized ratio target, thus decreasing the bleeding risk. This review will offer an in-depth survey of current guidelines, current evidence, suggested approach for PCI in this cohort, and future studies regarding mechanical valve patients undergoing PCI.

In-Stent Restenosis of Drug-Eluting Stents Compared With a Matched Group of Patients With De Novo Coronary Artery Stenosis.

Drug-eluting stents (DES) significantly reduced the incidence of in-stent restenosis (ISR). However, ISR still exists in the contemporary DES era. Previously deemed to be a benign process, ISR leads to complex presentation and intervention. This study aimed to compare the presentation and outcome of DES-ISR versus de novo lesions. We performed a retrospective analysis of 11,666 patients receiving percutaneous coronary intervention from 2003 to 2017 and divided them into 2 groups by de novo stenosis and ISR. They were matched based on common cardiovascular risk factors at a 4:1 ratio, respectively. After matching, a total of 1,888 patients with 3,126 de novo lesions and 472 patients with 508 ISR lesions were analyzed. Patients with ISR presented more often with unstable angina (61% vs 45%, p <0.001) and less often with myocardial infarction (6% vs 14%, p <0.001). One-year composite major adverse cardiovascular event, defined as death, Q-wave myocardial infarction, and target vessel revascularization, was 10% in the de novo group and 17% in the ISR group (hazard ratio 1.98, 95% confidential interval 1.58 to 2.46, p <0.001). After adjusting for myocardial infarction presentation, hazard ratio of major adverse cardiovascular events was still higher for the ISR group at 1 year (2.03, 95% confidential interval 1.62 to 2.55, p <0.001). ISR of DES remains a therapeutic challenge and leads to complex presentation and worse outcomes compared with matched de novo patients. These data show that DES-ISR demands better appreciation and prevention with more precise stent technique and should motivate the continued development of fully bioresorbable scaffolds.

MynxGrip® vascular closure device versus manual compression for hemostasis of percutaneous transfemoral venous access closure: Results from a prospective multicenter randomized study.

PURPOSE: Evaluate the safety of MynxGrip® for common femoral vein closure. METHODS AND MATERIALS: This is a multicenter, randomized, prospective study of 208 patients who were slated to undergo diagnostic/interventional procedures via femoral venous access. Patients were randomized 1:1 to receive venous hemostasis via MynxGrip® (n = 104) or manual compression (n = 104) utilizing 5, 6, and 7 Fr sheaths. Bilateral calf and thigh circumferences were measured serially. Patients were followed up through hospital discharge. There were no differences in the baseline characteristics between the two groups. RESULTS: There was no difference between the groups for venous thrombosis, (0%, p = 1). Overall, there was no significant change in access site calf (-0.18 ±â€¯1.38 cm, p = 0.18) or thigh diameter (0.33 ±â€¯2.86, p = 0.81). In both groups, none of the patients had major or minor vascular complications, access site infection, nerve injury, or access site bleeding requiring transfusion. The pre- to post-procedure hemoglobin drop was -0.51 ±â€¯1.1 vs. -0.64 ±â€¯1.3 g/dL, p = 0.59 in the manual compression group and MynxGrip® group, respectively. Time to hemostasis, was significantly lower in the MynxGrip® group compared to the manual compression group with 0.12 ±â€¯0.89 vs. 7.6 ±â€¯5.7 min, respectively (p < 0.001). CONCLUSIONS: The MynxGrip® extravascular sealant is safe and effective for femoral venous access site closure.

The impact of in-hospital P2Y12 inhibitor switch in patients with acute coronary syndrome.

BACKGROUND/PURPOSE: Dual antiplatelet therapy (DAPT) varies after placement of drug-eluting stents (DES) in patients presenting with acute coronary syndromes (ACS). Our aim was to study patient characteristics and predictors of switching, in-hospital or at discharge, from clopidogrel (CLO) to ticagrelor (TIC) or vice versa. METHODS/MATERIALS: The study population included patients with ACS who had DES and initially received either CLO or TIC between January 2011 and December 2017. Patients were divided into 4 groups based on initial DAPT choice and whether DAPT was switched in-hospital or during discharge. Clinical outcomes of interest were bleeding events, need for anticoagulation, and need for in-hospital coronary artery bypass graft (CABG). RESULTS: We identified 2837 patients who received DES and started on DAPT. DAPT switch from 1 P2Y12 inhibitor to another occurred in 9%, either in-hospital or at discharge. Of 1834 patients started on CLO, 112 were switched to TIC. Of 1003 patients started on TIC, 142 were switched to CLO. The need for in-hospital CABG was 7.8% in the TIC-CLO group compared to none in the CLO-TIC group (p = 0.002). Adjusted for covariates, the TIC-CLO group was 3 times more likely to need anticoagulation with warfarin than the CLO-CLO group (p < 0.001) and over 5 times more likely than the CLO-TIC group and the TIC-TIC group (p < 0.005 for both). CONCLUSIONS: Switching from 1 generation P2Y12 inhibitor to another does occur in ACS patients. Clinical needs such as in-hospital CABG or oral anticoagulation upon discharge are real and dictate the switch from TIC to CLO. SUMMARY: A single-center observational study of 2837 patients with acute coronary syndromes treated with drug-eluting stents found that some do get switched from one generation P2Y12 inhibitor to another. The switch from clopidogrel to ticagrelor is driven by clinical needs such as in-hospital coronary artery bypass grafting or the need for oral anticoagulation upon discharge.

Clinical Characteristics, Procedural Factors, and Outcomes of Percutaneous Coronary Intervention in Patients With Mechanical and Bioprosthetic Heart Valves.

There is scarcity of evidence regarding antiplatelet and anticoagulant therapy in patients with prosthetic valves undergoing percutaneous coronary intervention (PCI). Our goal was to compare clinical outcomes between patients with mechanical or bioprosthetic valves undergoing PCI. The study population comprised patients with either a bioprosthetic or mechanical heart valve in the aortic and/or mitral position undergoing PCI between January 2003 and July 2017. Demographics, admission, and discharge medications as well as procedural details were documented. Outcomes were postprocedural bleeding, length of stay, and in-hospital deaths. Of 211 patients, we identified 119 and 92 patients with a bioprosthetic or mechanical valve, respectively. Mean age was 75 ± 9 years and 66 ± 12 years in bioprosthetic and mechanical valve patients, respectively. Bare-metal stents were used in 18.2% and 30.1% of bioprosthetic and mechanical valve patients, respectively. Major bleeding was documented in 0.8% and 6.5% of bioprosthetic and mechanical valve patients, respectively (p = 0.04). Use of triple therapy (aspirin AND clopidogrel AND oral vitamin K antagonist) was significantly lower in bioprosthetic valve patients compared with mechanical valve patients (12% vs 68%, p <0.001). Our study shows variation in periprocedural anticoagulation and/or antiplatelet choice exists in this population. Patients with mechanical valves experienced higher rates of major bleeding compared with patients with bioprosthetic valves, which could be due to concomitant anticoagulation and dual antiplatelet therapy.