Objectives The purpose of this prospective registry was to evaluate the safety and efficacy, at 1 year, of the use of drug-eluting balloons (DEB) for the treatment of superficial femoral artery (SFA) ...in-stent restenosis (ISR). Background The use of the self-expanding nitinol stent has improved the patency rate of SFA after percutaneous transluminal angioplasty (PTA). As the population with SFA stenting continues to increase, occurrence of ISR has become a serious problem. The use of DEB has showed promising results in reducing restenosis recurrence in coronary stents. Methods From December 2009 to December 2010, 39 consecutive patients underwent PTA of SFA-ISR in our institution. All patients underwent conventional SFA PTA and final post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic, Minneapolis, Minnesota). Patients were evaluated up to 12 months. Results Technical and procedural success was achieved in every patient. No in-hospital major adverse cardiac and cerebrovascular events occurred. At 1 year, 1 patient died due to heart failure. Primary endpoint, primary patency rate at 12 months, was obtained in 92.1% (35 patients). At 1 year, patients were asymptomatic for claudication, and duplex assessment demonstrated lack of recurrent restenosis (100% rate of Secondary patency). The presence of an occlusive restenosis at the time of treatment was not associated with an increased restenosis rate, when compared with non-occlusive restenosis, at 1 year. Conclusions The data suggest that adjunctive use of DEB for the treatment of SFA-ISR represents a potentially safe and effective therapeutic strategy. These data should be considered hypothesis-generating to design a randomized trial.
Abstract Background Common clinical practice recommends dual antiplatelet therapy (DAPT) for transcatheter aortic valve implantation (TAVI). The aim of the study was to evaluate, in a double blind ...randomized study, the safety of TAVI, with adjunctive pharmacotherapy consisting of single antiplatelet therapy. Methods and results From April 2010 to April 2011, 120 consecutive patients, undergoing TAVI, have been enrolled in the study. Patients were randomly assigned to DAPT group (aspirin and clopidogrel 75 mg/qd or ticlopidine 500 mg/bid) or ASA group (aspirin only). TAVI device was the Sapien XT-Novaflex Delivery System (Edwards Lifesciences, Inc.). All patients were followed up to 6 months. Device success was achieved in 100% of patients. No difference in the VARC combined 30 day safety endpoint, all cause and cardiovascular mortality was observed. At 30 days vascular complications were reduced in the ASA group ( p < 0.05). No differences in the clinical status were detected between the groups up to 6 months. Conclusions This study suggests that TAVI procedures can be performed without DAPT without increasing the morbidity and mortality. These findings, if confirmed in a larger multicenter randomized trial, will no longer support the use of DAPT for TAVI.
Cuffless blood pressure (CL-BP) measurements are believed to be a potentially alternative to cuff-occlusion-based (C-BP) measurement. A new cuffless device was developed for ambulatory BP monitoring. ...We assessed the accuracy of a new CL-BP device compared to a standard oscillatory C-BP device over the 24 h.
Eighty-four consecutive patients were included in the study. BP was measured simultaneously by the CL-BP device and by a C-BP device over the 24 h. Calculations included 24 h mean systolic (S) BP, the mean diastolic (D) BP and the heart rate (HR). Correlations between the CL-BP and C-BP measurements were sought using Pearson's correlation coefficients and Bland-Altman plots.
Using the C-BP device, the 24 h SBP value for the cohort was 125.4 ± 10.9 mmHg (mean ± SD); the corresponding DBP value being 75 ± 8.3 mmHg. Mean SBP/DBP were higher with the CL-BP device, i.e. 131.1 ± 15.9/80.2 ± 9.7 mmHg . The correlation coefficients between the two sets of values were significant (SBP: r = 0.58, DBP: r = 0.65). Better correlations for SBP and DBP were found 1) in patients with BMI > 25 (SBP: r = 0.65, DBP: r = 0.70) compared to those with BMI <25 and 2) in males compared to females (SBP: r = 0.71, DBP: r = 0.77).
In our patients a CL-BP device estimated 24 h mean SBP and DBP differently from the classical oscillometric device, with a moderate correlation. CL-BP measurements were most accurate on male and overweight subjects.
Hypothesis- By acting at two levels(vessel wall & tissue) access site hemostatic control can be achieved effectively. Conclusion This technique is a simple, safe & cost-effective method of successful ...access site closure leading to better clinical outcomes and may be considered as a valid option during TAVI/TAAR.
Background Estimation of the balance between subendocardial oxygen supply and demand could be a useful parameter to assess the risk of myocardial ischemia. Evaluation of the subendocardial viability ...ratio (SEVR, also known as Buckberg index) by invasive recording of left ventricular and aortic pressure curves represents a valid method to estimate the degree of myocardial perfusion relative to left ventricular workload. However, routine clinical use of this parameter requires its noninvasive estimation and the demonstration of its reliability. Methods and Results Arterial applanation tonometry allows a noninvasive estimation of SEVR as the ratio of the areas directly beneath the central aortic pressure curves obtained during diastole (myocardial oxygen supply) and during systole (myocardial oxygen demand). However, this "traditional" method does not account for the intra-ventricular diastolic pressure and proper allocation to systole and diastole of left ventricular isometric contraction and relaxation, respectively, resulting in an overestimation of the SEVR values. These issues are considered in the novel method for SEVR assessment tested in this study. SEVR values estimated with carotid tonometry by "traditional" and "new" method were compared with those evaluated invasively by cardiac catheterization. The "traditional" method provided significantly higher SEVR values than the reference invasive SEVR: average of differences±SD= 44±11% (limits of agreement: 23% - 65%). The noninvasive "new" method showed a much better agreement with the invasive determination of SEVR: average of differences±SD= 0±8% (limits of agreement: -15% to 16%). Conclusions Carotid applanation tonometry provides valid noninvasive SEVR values only when all the main factors determining myocardial supply and demand flow are considered.
To the Editor: Surgical replacement of the aortic valve reduces symptoms and improves survival in patients with symptomatic and severe aortic stenosis (1). Transcatheter aortic valve replacement ...(TAVR) provides a safe and efficient alternative for inoperable and high-risk surgical patients (2-4).
Objectives We sought to evaluate, in a double-blind, randomized, prospective study, safety and efficacy of elective percutaneous coronary intervention (PCI), with pharmacotherapy consisting of ...antiplatelet therapy and no anticoagulation therapy. Background Available guidelines recommend systemic anticoagulation agent use during PCI. Significant debate remains, however, with regard to the correlation between the effects of systemic anticoagulation therapy and ensuing ischemic and hemorrhagic complications. Methods From June 2005 to January 2007, 700 patients undergoing elective PCI of an uncomplicated lesion have been prospectively enrolled in the protocol. Patients should have been on aspirin and thienopyridine therapy and were assigned either to the control arm (70 to 100 UI/kg unfractionated heparin) or to the no-heparin arm. A clinical assessment was obtained before hospital discharge and at 30 days after PCI. Results Procedural success was obtained in 100% of the cases. No acute or subacute thrombosis was observed. The absence of anticoagulation therapy was associated with a significant decrease in post-procedural myocardial damage (p = 0.03) and bleeding events (p = 0.048). At 30 days, the primary end point (death, myocardial infarction, or urgent target vessel revascularization) was more frequent in the control arm than in the no-heparin arm (2.0% vs. 3.7%, respectively; absolute risk reduction 1.7% 95% confidence interval: −0.1% to 4.5%, p for superiority = 0.17, p for noninferiority <0.001). Conclusions In the treatment of uncomplicated lesions and in the presence of dual antiplatelet therapy, elective PCI can be safely performed without systemic anticoagulation and is associated with a reduced incidence of bleeding complications.
Aortic pulse wave velocity is a worldwide accepted index to evaluate aortic stiffness and can be assessed noninvasively by several methods. This study sought to determine if commonly used noninvasive ...devices can all accurately estimate aortic pulse wave velocity. Pulse wave velocity was estimated in 102 patients (aged 65±13 years) undergoing diagnostic coronary angiography with 7 noninvasive devices and compared with invasive aortic pulse wave velocity. Devices evaluating carotid-femoral pulse wave velocity (Complior Analyse, PulsePen ET, PulsePen ETT, and SphygmoCor) showed a strong agreement between each other (r>0.83) and with invasive aortic pulse wave velocity. The mean difference ±SD with the invasive pulse wave velocity was −0.73±2.83 m/s (r=0.64) for Complior-Analyse0.20±2.54 m/s (r=0.71) for PulsePen-ETT−0.04±2.33 m/s (r=0.78) for PulsePen ET; and −0.61±2.57 m/s (r=0.70) for SphygmoCor. The finger-toe pulse wave velocity, evaluated by pOpmètre, showed only a weak relationship with invasive aortic recording (mean difference ±SD =−0.44±4.44 m/s; r=0.41), and with noninvasive carotid-femoral pulse wave velocity measurements (r<0.33). Pulse wave velocity estimated through a proprietary algorithm by BPLab (v.5.03 and v.6.02) and Mobil-O-Graph showed a weaker agreement with invasive pulse wave velocity compared with carotid-femoral pulse wave velocity (mean difference ±SD =−0.71±3.55 m/s, r=0.23; 1.04±2.27 m/s, r=0.77; and −1.01±2.54 m/s, r=0.71, respectively), revealing a negative proportional bias at Bland-Altman plot. Aortic pulse wave velocity values provided by BPLab and Mobil-O-Graph were entirely dependent on age-squared and peripheral systolic blood pressure (cumulative r=0.98 and 0.99, respectively). Thus, among the methods evaluated, only those assessing carotid-femoral pulse wave velocity (Complior Analyse, PulsePen ETT, PulsePen ET, and SphygmoCor) appear to be reliable approaches for estimation of aortic stiffness.
Objective
To investigate if invasively measured aortic pulse wave velocity (PWV) is accurately estimated by non-invasive methods purporting to assess it. Methods: One-hundred and two patients (30% ...female, age 65 ± 13 years) planned to undertake coronary angiography were evaluated with the following non-invasive devices: BPLab (Petr Telegin, Russia), Complior Analyse (Alam Medical, France), Mobil-O-Graph (IEM, Germany), pOpmètre (Axelife, France), PulsePen-ET, PulsePen-ETT (Diatecne, Italy) and SphygmoCor (AtCor, Australia). Aortic PWV was measured by aortic catheterization and simultaneous measurement of pressure waves above the aortic valve and at the aortic bifurcation (FS-Stiffcath, Flag Vascular, Italy).
Results
The devices evaluating carotid-femoral PWV showed a very strong agreement between each other (r2 > 0.65) and with invasive aortic PWV (mean difference ± SDwith invasive PWV: −0.73 ± 2.83 m/s (r2 = 0.41) for Complior-Analyse; 0.20 ± 2.54 m/s (r2 = 0.51) for PulsePen-ETT; −0.04 ± 2.33 m/s (r2 = 0.61) for PulsePen-ET; −0.61 ± 2.57m/s (r2 = 0.49) for SphygmoCor). The finger-toe PWV, evaluated by the pOpmètre, and the PWV measured by BPLab showed a weak relationship with invasive PWV (respectively r 2 = 0.12, 0.05), with carotid-femoral PWV measurements (r 2 = 0.11, 0.010) and with age (r 2 = 0.10, 0.06). PWV estimated with Mobil-O-Graph through a proprietary algorithm showed a good agreement with invasive PWV (mean difference ± SD = −1.01 ± 2.54 m/s; r2 = 0.51) and appeared to be strictly dependent on age-squared and peripheral systolic blood pressure (r2 > 0.99).
Conclusions
Methods estimating carotid-femoral PWV should be considered the only non-invasive approach to reliably assess aortic stiffness. Aortic PWV values estimated by Mobil-O-Graph algorithm are also significantly related to invasive PWV, but do not offer any additional information on top of what provided by age and systolic blood pressure levels.
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