The Acute Hemodynamic Effects of MitraClip Therapy Siegel, Robert J., MD; Biner, Simon, MD; Rafique, Asim M., MD ...
Journal of the American College of Cardiology,
04/2011, Letnik:
57, Številka:
16
Journal Article
Recenzirano
Odprti dostop
Objectives The objective of this study was to evaluate the acute hemodynamic consequences of mitral valve (MV) repair with the MitraClip device (Abbott Vascular, Menlo Park, California). Background ...Whether surgical correction of mitral regurgitation (MR) results in a low cardiac output (CO) state because of an acute increase in afterload remains controversial. The acute hemodynamic consequences of MR reduction with the MitraClip device have not been studied. Methods We evaluated 107 patients with cardiac catheterization before and immediately following percutaneous MV repair with the MitraClip device. In addition, pre- and post-procedural hemodynamic parameters were studied by transthoracic echocardiography. Results MitraClip treatment was attempted in 107 patients, and in 96 (90%) patients, a MitraClip was deployed. Successful MitraClip treatment resulted in: 1) an increase in CO from 5.0 ± 2.0 l/min to 5.7 ± 1.9 l/min (p = 0.003); 2) an increase in forward stroke volume (FSV) from 57 ± 17 ml to 65 ± 18 ml (p < 0.001); and 3) a decrease in systemic vascular resistance from 1,226 ± 481 dyn·s/cm5 to 1,004 ± 442 dyn·s/cm5 (p < 0.001). In addition, there was left ventricular (LV) unloading manifested by a decrease in LV end-diastolic pressure from 11.4 ± 9.0 mm Hg to 8.8 ± 5.8 mm Hg (p = 0.016) and a decrease in LV end-diastolic volume from 172 ± 37 ml to 158 ± 38 ml (p < 0.001). None of the patients developed acute post-procedural low CO state. Conclusions Successful MV repair with the MitraClip system results in an immediate and significant improvement in FSV, CO, and LV loading conditions. There was no evidence of a low CO state following MitraClip treatment for MR. These favorable hemodynamic effects with the MitraClip appear to reduce the risk of developing a low CO state, a complication occasionally observed after surgical MV repair for severe MR. (A Study of the Evalve Cardiovascular Valve Repair System Endovascular Valve Edge-to-Edge Repair Study EVEREST I; NCT00209339 and EVEREST II; NCT00209274 )
Heart failure with preserved ejection fraction represents a major unmet clinical need with limited treatment options. Recent device therapies under investigation have focused on decompression of the ...left atrium through an implantable interatrial shunt. Although these devices have shown favorable safety and efficacy signals, an implant is required to maintain shunt patency, which may increase the patient risk profile and complicate subsequent interventions requiring transseptal access.
The Alleviant System is a no-implant approach to creating an interatrial shunt using radiofrequency energy to securely capture, excise, and extract a precise disk of tissue from the interatrial septum. Acute preclinical studies in healthy swine (n = 5) demonstrated the feasibility of the Alleviant System to repeatably create a 7 mm interatrial orifice with minimal collateral thermal effect and minimal platelet and fibrin deposition observed histologically.
Chronic animal studies (n = 9) were carried out to 30- and 60-day time points and exhibited sustained shunt patency with histology demonstrating completely healed margins, endothelialization, and no trauma to adjacent atrial tissue. Preliminary clinical safety and feasibility were validated in a first-in-human study in patients with heart failure with preserved ejection fraction (n = 15). All patients demonstrated shunt patency by transesophageal echocardiographic imaging at 1, 3, and 6 months, as well as cardiac computed tomography imaging at 6-month follow-up timepoints.
Combined, these data support the safety and feasibility of a novel no-implant approach to creating an interatrial shunt using the Alleviant System. Continued follow-up and subsequent clinical studies are currently ongoing.
•Patency of interatrial shunts via radiofrequency septectomy is maintained in swine and humans.•Interatrial shunts created via radiofrequency septectomy heal with minimal thermal effect.•A no-implant shunt method may be beneficial for treating congestive heart failure.
Percutaneous Mitral Repair With the MitraClip System Feldman, Ted, MD; Kar, Saibal, MD; Rinaldi, Michael, MD ...
Journal of the American College of Cardiology,
08/2009, Letnik:
54, Številka:
8
Journal Article
Recenzirano
Odprti dostop
Objectives We undertook a prospective multicenter single-arm study to evaluate the feasibility, safety, and efficacy of the MitraClip system (Evalve Inc., Menlo Park, California). Background Mitral ...valve repair for mitral regurgitation (MR) has been performed by the use of a surgically created double orifice. Percutaneous repair based on this surgical approach has been developed by use of the Evalve MitraClip device to secure the mitral leaflets. Methods Patients with 3 to 4+ MR were selected in accordance with the American Heart Association/American College of Cardiology guidelines for intervention and a core echocardiographic laboratory. Results A total of 107 patients were treated. Ten (9%) had a major adverse event, including 1 nonprocedural death. Freedom from clip embolization was 100%. Partial clip detachment occurred in 10 (9%) patients. Overall, 79 of 107 (74%) patients achieved acute procedural success, and 51 (64%) were discharged with MR of ≤1+. Thirty-two patients (30%) had mitral valve surgery during the 3.2 years after clip procedures. When repair was planned, 84% (21 of 25) were successful. Thus, surgical options were preserved. A total of 50 of 76 (66%) successfully treated patients were free from death, mitral valve surgery, or MR >2+ at 12 months (primary efficacy end point). Kaplan-Meier freedom from death was 95.9%, 94.0%, and 90.1%, and Kaplan-Meier freedom from surgery was 88.5%, 83.2%, and 76.3% at 1, 2, and 3 years, respectively. The 23 patients with functional MR had similar acute results and durability. Conclusions Percutaneous repair with the MitraClip system can be accomplished with low rates of morbidity and mortality and with acute MR reduction to < 2+ in the majority of patients, and with sustained freedom from death, surgery, or recurrent MR in a substantial proportion (EVEREST I; NCT00209339 . EVEREST II; NCT00209274 ).
Abstract The Canadian Cardiovascular Society Heart Failure (HF) Guidelines Program has generated annual HF updates, including formal recommendations and supporting Practical Tips since 2006. Many ...clinicians indicate they routinely use the Canadian Cardiovascular Society HF Guidelines in their daily practice. However, many questions surrounding the actual implementation of the Guidelines into their daily practice remain. A consensus-based approach was used, including feedback from the Primary and Secondary HF Panels. This companion is intended to answer several key questions brought forth by HF practitioners such as appropriate timelines for initial assessments and subsequent reassessments of patients, the order in which medications should be added, how newer medications should be included in treatment algorithms, and when left ventricular function should be reassessed. A new treatment algorithm for HF with reduced ejection fraction is included. Several other practical issues are addressed such as an approach to management of hyperkalemia/hypokalemia, treatment of gout, when medications can be stopped, and whether a target blood pressure or heart rate is suggested. Finally, elements and teaching of self-care are described. This tool will hopefully function to allow better integration of the HF Guidelines into clinical practice.
Abstract Background In EVEREST II (Endovascular Valve Edge-to-Edge Repair Study), treatment of mitral regurgitation (MR) with a novel percutaneous device showed superior safety compared with surgery, ...but less effective reduction in MR at 1 year. Objectives This study sought to evaluate the final 5-year clinical outcomes and durability of percutaneous mitral valve (MV) repair with the MitraClip device compared with conventional MV surgery. Methods Patients with grade 3+ or 4+ MR were randomly assigned to percutaneous repair with the device or conventional MV surgery in a 2:1 ratio (178:80). Patients prospectively consented to 5 years of follow-up. Results At 5 years, the rate of the composite endpoint of freedom from death, surgery, or 3+ or 4+ MR in the as-treated population was 44.2% versus 64.3% in the percutaneous repair and surgical groups, respectively (p = 0.01). The difference was driven by increased rates of 3+ to 4+ MR (12.3% vs. 1.8%; p = 0.02) and surgery (27.9% vs. 8.9%; p = 0.003) with percutaneous repair. After percutaneous repair, 78% of surgeries occurred within the first 6 months. Beyond 6 months, rates of surgery and moderate-to-severe MR were comparable between groups. Five-year mortality rates were 20.8% and 26.8% (p = 0.4) for percutaneous repair and surgery, respectively. In multivariable analysis, treatment strategy was not associated with survival. Conclusions Patients treated with percutaneous repair more commonly required surgery for residual MR during the first year after treatment, but between 1- and 5-year follow-up, comparably low rates of surgery for MV dysfunction with either percutaneous or surgical therapy endorse the durability of MR reduction with both repair techniques. (EVEREST II Pivotal Study High Risk Registry; NCT00209274 )
A Report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, American College of Radiology, American Institute of Ultrasound in Medicine, American Society of ...Echocardiography, American Society of Nephrology, Intersocietal Commission for the Accreditation of Vascular Laboratories, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Interventional Radiology, Society for Vascular Medicine, and Society for Vascular Surgery Technical Panel Michael J. Wolk, MD, MACC, Moderator Emile R. Mohler III, MD, FACC, Writing Group Liaison Bradley S. Dixon, MD**American Society of Nephrology Representative Vickie R. Driver, DPM, MSdaggerdaggerAmerican Podiatric Medical Association Representative Peter S. Fail, MD, FSCAIdouble daggerdouble daggerSociety of Cardiovascular Computed Tomography Representative Reza Fazel, MD, MSc* Laura Findeiss, MD, FSIR|| Richard Fuchs, MD, FACC* John Gillespie, MD* Joseph P. Hughes, RVT, RVS, FSVU§§Society for Vascular Ultrasound Representative Cheryl Jaigobin, MD|||American Academy of Neurology Representative Steven A. Leers, MD¶¶Society for Clinical Vascular Surgery Representative##Intersocietal Commission for the Accreditation of Vascular Laboratories Representative Colleen Moore, MD# John S. Pellerito, MD, FACR, FAIUM§***American Institute of Ultrasound in Medicine Representative Michelle L. Robbin, MD, FACR, FAIUM§ Rita E. Shugart, RN, RVT, FSVUdagger Fred A. Weaver, MD, MMM## Christopher J. White, MD, FSCAI¶daggerdaggerdaggerSociety for Cardiovascular Angiography and Interventions Representative Alexander S. Yevzlin, MD** Appropriate Use Criteria Task Force Michael J. Wolk, MD, MACC, Chair Steven R. Bailey, MD, FACC, FSCAI, FAHA Pamela S. Douglas, MD, MACC, FAHA, FASE Robert C. Hendel, MD, FACC, FAHA, FASNC Christopher M. Kramer, MD, FACC, FAHA James K. Min, MD, FACC Manesh R. Patel, MD, FACC Leslee Shaw, PhD, FACC, FASNC Raymond F. Stainback, MD, FACC, FASE Joseph M. Allen, MA Table of Contents Abstract... The ACCF believes that careful blending of a broad range of clinical experiences and available evidence-based information will help guide a more efficient and equitable allocation of healthcare resources in cardiovascular imaging.\n Hughes None None None None None None Cheryl Jaigobin None None None None None None Steven A. Leers None None None None None None Colleen Moore None None None Aastrom Cloysis Ekos Vascular Solutions None Department of Defense John S. Pellerito None None None None None None Michelle L. Robbin Philips Ultrasound None None National Institutes of Health None None Rita E. Shugart None None None None None None Fred A. Weaver WL Gore None None Executive committee, HOPE4HF trial None None Christopher J. White None None None None None None Alexander S. Yevzlin None None None None None None Peripheral Vascular Ultrasound and Physiological Testing External Reviewers Mouaz H. Al-Mallah None None None None None None Clifford T. Araki None None None None None None Curtis W. Bakal None None None None None None Phillip J. Bendick None GE Ultrasound Zonare Ultrasound None None None None Raymond Edward Bertino None None None None None None Robert W. W. Biederman None Merck-Schering-Plough None Merck-Schering-Plough (MRI research) Osiris Steering committee (no financial support) None None John Blebea None None None None None None Andressa G. R. Borges None None None None None None Doug Campos-Outcalt None None None None None None Kathleen A. Carter None None None None None None Donald E. Casey Jr None None None None None None Alan M. Dietzek None International RN Congress None None None None Regina S. Druz None None None None None None Troy Fiesinger None None None None None None Naomi Hamburg None None None None None None Sujith Kalathiveetil None None None None None None Jengyu Lai None None None None None None Carol Miranda None None None None None None Steffen E. Petersen None None None None None None Patricia (Tish) A. Poe None None None None None None Robert R. Ross None None None None None None Lawrence Rudski None None None None None None Russell H. Samson None None None None None None Aseem Vashist None None None None None None James Wrobel None None None None None None * This table represents the relevant relationships with industry and other entities that were disclosed by participants at the time of participation. A person is deemed to have a significant interest in a business if the interest represents ownership of 5% of the voting stock or share of the business entity, or ownership of $10,000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person's gross income for the previous year.
Purpose:
To report the technique of carotid endarterectomy (CEA) combined with retrograde balloon angioplasty and stenting of proximal “tandem” lesions in the supra-aortic trunk.
Technique:
...Intraoperative techniques in 34 patients with 23 left common carotid artery (CCA) and 11 innominate artery lesions included general anesthesia, low-dose dextran, prosthetic patching, selective shunting, 8-F sheath entry into the native CCA before the CEA, manual CCA sizing, and balloon-expandable stent placement after predilation. The technique has a high procedural success rate (97%) and appears durable. Over a mean 34-month follow-up, 2 >70% ostial CCA restenoses were found at 24 months.
Conclusions:
Intraoperative innominate or left CCA balloon angioplasty/stenting combined with carotid endarterectomy is safe, effective, and durable.
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