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Objectives

This study sought to evaluate the Medtronic Evolut PRO Transcatheter Aortic Valve System in patients with severe symptomatic aortic stenosis.

Background

A next-generation self-expanding transcatheter aortic valve was designed with an external pericardial wrap with the intent to reduce paravalvular leak while maintaining the benefits of a low-profile, self-expanding, and repositionable supra-annular valve.

Methods

The Medtronic Evolut PRO Clinical Study included 60 patients undergoing transcatheter aortic valve replacement with the Evolut PRO valve at 8 investigational sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. The 2 primary safety endpoints were the incidence of all-cause mortality at 30 days and the incidence of disabling stroke at 30 days. The primary efficacy endpoint was the proportion of patients with no or trace prosthetic valve regurgitation at 30 days. An independent echocardiographic core laboratory (Mayo Clinic, Rochester, Minnesota) was used to adjudicate all echocardiographic assessments.

Results

All 60 patients received the Evolut PRO valve. At 30 days, 1 patient (1.7%) died and 1 patient (1.7%) experienced a nonfatal disabling stroke. Paravalvular regurgitation at 30 days was absent or trace in 72.4% of patients and was mild in the remainder of patients, with no patients having worse than mild paravavlular leak. The mean atrioventricular gradient was 6.4 ± 2.1 mm Hg and effective orifice area was 2.0 ± 0.5 cm2 at 30 days.

Conclusions

The safety and efficacy results of this study support the use of the Evolut PRO System for the treatment of severe symptomatic aortic stenosis in patients who are at increased surgical risk, resulting in excellent hemodynamics and minimal paravalvular leak (The Medtronic TAVR 2.0 US Clinical Study; NCT02738853)  相似文献   

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Objectives

The aim of this study was to identify the optimal endovascular approach in patients with acute stroke with tandem lesions.

Background

At present, there is no consensus about the ideal technical strategy for the endovascular treatment of patients with acute ischemic stroke with tandem lesions of the extracranial internal carotid artery (ICA) and intracranial cerebral arteries.

Methods

This was an international, multicenter registry with a total of 482 patients with acute ischemic stroke and tandem lesions. Patients were treated by intracranial thrombectomy as well as 1 of the following 4 strategies: 1) acute carotid artery stenting of the extracranial ICA with antithrombotic agents; 2) acute carotid artery stenting of the extracranial ICA without antithrombotic agents; 3) balloon angioplasty of the extracranial ICA; and 4) intracranial thrombectomy alone. The main outcome endpoints of the study were the degree of recanalization and the 90-day clinical outcome. The safety endpoints were symptomatic intracerebral hemorrhage and all causes of mortality at 90 days.

Results

Using univariate analysis, the rates of successful reperfusion (modified Thrombolysis in Cerebral Infarction grades 2B and 3) and favorable clinical outcome after 90 days were significantly higher after acute carotid stenting with antithrombotic therapy and thrombectomy compared with the group with thrombectomy alone. After adjusting for confounding variables, acute stenting with antithrombotic therapy was independently associated with successful recanalization (odds ratio: 2.4; 95% confidence interval: 1.25 to 4.59; p = 0.008). The rates of symptomatic intracerebral hemorrhage and 90-day mortality were comparable among all 4 treatment groups.

Conclusions

Acute stenting of the extracranial ICA with antithrombotic therapy in combination with intracranial thrombectomy is associated with higher recanalization rates in treatment of patients with acute stroke with tandem lesions.  相似文献   

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Recruitment of older adults with advanced heart failure is notoriously challenging, particularly for doctoral students conducting dissertation research studies with limited financial and personnel resources. Successful recruitment of participants requires a multifaceted recruitment strategy that is mindful of context and sensitive to the clinical partners who provide care in the recruitment setting. This article reflects on these challenges and proposes a practical framework to guide recruitment strategies in future research.  相似文献   

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African Americans have a higher prevalence, earlier onset, and more rapid progression of hypertensive end-organ disease, as well as excessive hypertensive mortality compared with other racial/ethnic groups. Most differences in hypertension and pressure-related complications between African Americans and whites appear to be quantitative and not qualitative. Improving the diagnosis, treatment, and control of hypertension in this highly vulnerable population is a major health care goal for the new millennium. In this regard the dietary pattern to be promoted for reduction of hypertension risk in African Americans is one of increased consumption of dairy products, fruit, and vegetables as well as a continued emphasis on decreased Na+ intake. When pharmacologic therapy is considered, multi-drug approaches are generally required, with diuretics, angiotensin-converting enzyme inhibitors (or angiotensin receptor blockers), and calcium channel blocker therapy as oft-selected components of most such treatment regimens.  相似文献   

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Estimates of the bone marrow granulocyte reserve were made in 97 patients with lymphoma utilizing theendotoxin Pyrexal. Normal granulocyteresponses were observed in mostpatients who had not received priormyelosuppressive therapy. Patientswith lymphosarcoma responded aswell as those with Hodgkin’s Disease.All patients with leukopenia due toprevious therapy or marrow infiltrationfailed to respond. In the absence ofleukopenia only 47% of previouslytreated patients achieved normal responses. The severity of granulocytopenia produced by intravenous alkylating agent therapy was correlated withpretreatment Pyrexal responses. Patients with normal granulocyte reserves, as demonstrated by this test,tolerated subsequent chemotherapywith significantly less severe granulocytopenia (p <0.02) than patients withabnormal test responses. Nadir granulocyte values below 1000 cells/cu mmdeveloped in 7 of 33 patients withnormal Pyrexal responses and in 11 of15 abnormal responders, despite comparable pretreatment granulocytevalues.

Submitted on March 19, 1971 Revised on October 8, 1971 Accepted on October 23, 1971  相似文献   

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