Biomedical subjects
Publications and source records attributed to Ted Feldman.
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We describe percutaneous closure of an unusual paravalvular leak, with a communication from the noncoronary cusp of the aortic valve to the left atrium adjacent to a St. Jude mitral valve prosthesis, in the absence of an infection. The patient presented with worsening dyspnea and edema. The anatomic location of the valve annulus adjacent to the noncoronary cusp underlies the etiology of this communication. Outcomes from surgical repair are associated with high mortality. We performed percutaneous closure of the defect, using general anesthesia and transesophageal echo guidance. An Amplatzer duct occluder was placed in the fistula, with immediate and complete closure of the shunt. While no devices specific for closure of paravalvular leaks have been designed, growing experience with a variety of devices and the use of echo guidance have allowed successful therapy in many complex cases.
An 85-year-old man was found to have a 9 cm diameter true aneurysm of an obtuse marginal saphenous vein graft. The graft was fed by a relatively narrow neck from the proximal remnant of the obtuse marginal graft 10 years after prior coronary artery bypass graft surgery. An Amplatzer vascular plug was used successfully to occlude the neck of the aneurysm. Follow-up CT scan 1 month afterward demonstrated retained contrast in the aneurysm, demonstrating complete occlusion between the aorta and aneurysm sac. Pressure recordings from within the aneurysm sac suggest bidirectional flow in the neck as the mechanism for the maintained patency of the aneurysm. The use of a vascular plug is an effective method for aneurysm occlusion when the anatomy is suitable.
INTRODUCTION: The Endovascular Valve Edge-to-Edge REpair STudies (EVEREST) are investigating a percutaneous technique for edge-to-edge mitral valve repair with a repositionable clip. The effects on the mitral valve gradient (MVG) and mitral valve area (MVA) are not known. METHODS: Twenty seven patients with moderate to severe or severe mitral regurgitation (MR) were enrolled. Echocardiography was performed preprocedure, at discharge, and at 1, 6, and 12 months. Mean MVG was measured by Doppler and MVA by planimetry and pressure half-time, and evaluated in a central core laboratory. Pre- and postclip deployment, simultaneous left atrial/pulmonary capillary wedge and left ventricular pressures were obtained in eight patients. RESULTS: Three patients did not receive a clip, six patients had their clip(s) explanted by 6 months (none for mitral stenosis), and four were repaired with two clips. Results are notable for a slight increase in mean MVG by Doppler postclip deployment (1.79 +/- 0.89 to 3.31 +/- 2.09 mm Hg, P < 0.01) and an expected decrease in MVA by planimetry (6.49 +/- 1.61 to 4.46 +/- 2.14 cm(2), P < 0.001) and by pressure half time (4.35 +/- 0.98 to 3.01 +/- 1.42 cm(2), P < 0.05). There were no significant changes in hemodynamic parameters postclip deployment by direct pressure measurements. There was no change in MVA by planimetry from discharge to 12 months (3.90 +/- 1.90 to 3.79 +/- 1.54 cm(2), P = 0.78). CONCLUSIONS: Echocardiographic and hemodynamic measurements after percutaneous mitral valve repair with the MitraClip show an expected decrease in mitral valve area with no evidence of clinically significant mitral stenosis either immediately after clip deployment or after 12 months of follow-up.
Balloon aortic valvuloplasty (BAV) has been a highly successful therapy for children and young adults with aortic valve stenosis, resulting in both symptomatic improvement and durable increases in the aortic valve area. Despite enthusiasm for BAV in older adult patients with aortic valve stenosis in the mid-1980s, the therapy has had disappointing medium- and long-term outcomes. Survival of patients with aortic valve stenosis does not increase with BAV, and restenosis occurs in the vast majority of patients within 6-24 months after therapy. Despite these limitations, most patients are symptomatically improved for a year or more. BAV remains an effective palliative therapy for selected patients.
A variety of advances have recently facilitated development of methods to treat mitral regurgitation using catheter techniques via the percutaneous route. These include placing devices into the coronary sinus to support the mitral annulus and direct percutaneous leaflet repair. These approaches are already attractive for use in older patients and will hopefully make treatments available to many with no current options.
BACKGROUND: Little has been reported regarding the utility or outcomes of femoral venous vascular closure using arterial suture closure devices. We describe results using a pre-closure approach with a 6 French (Fr) Perclose Closer S device in patients who underwent antegrade aortic valvuloplasty using 14 Fr percutaneous femoral venous access catheters. METHODS: Forty-five patients underwent antegrade aortic valvuloplasty and suture-mediated closure with a 6 Fr Perclose device. A 6 Fr Closer S suture device was preloaded into the femoral vein after 6 Fr sheath access, prior to insertion of a 14 Fr venous sheath. Upon completion of the procedure, the 14 Fr femoral venous sheath was removed through the existing sutures. RESULTS: Of 45 patients (mean age 82.4 years; 17 males), immediate hemostasis was achieved with percutaneous suture closure in 43 (95.6%). Only 2 failures occurred which were subsequently successfully treated with manual compression. No late access site bleeding occurred from sutured sites. In all other patients, hemostasis using a 6 Fr Perclose suture-mediated device was successful and immediate. There was no need for transfusion, no clinical venous thrombosis, and no infections occurred at the access site. Two hospital deaths were documented from causes unrelated to suture-mediated closure. CONCLUSIONS: In conjunction with 14-Fr size percutaneous sheaths during antegrade aortic valvuloplasty, percutaneous suturemediated closure is a highly effective method for achieving hemostasis. This has simplified postprocedural management in terms of early mobilization and diminished late access site bleeding.
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OBJECTIVES: This study sought to evaluate the clinical results of a percutaneous approach to mitral valve repair for mitral regurgitation (MR). BACKGROUND: A surgical technique approximating the middle scallops of the mitral leaflets to create a double orifice with improved leaflet coaptation was introduced in the early 1990s. Recently, a percutaneous method to create the same type of repair was developed. A trans-septal approach was used to deliver a clip device that grasps the mitral leaflet edges to create the double orifice. METHODS: General anesthesia, fluoroscopy, and echocardiographic guidance are used. A 24-F guide is positioned in the left atrium. The clip is centered over the mitral orifice, passed into the left ventricle, and pulled back to grasp the mitral leaflets. After verification that MR is reduced, the clip is released. RESULTS: Twenty-seven patients had six-month follow-up. Clips were implanted in 24 patients. There were no procedural complications and four 30-day major adverse events: partial clip detachment in three patients, who underwent elective valve surgery, and one patient with post-procedure stroke that resolved at one month. Three additional patients had surgery for unresolved MR, leaving 18 patients free from surgery. In 13 of 14 patients with reduction of MR to < or =2+ after one month, the reduction was maintained at six months. CONCLUSIONS: Percutaneous edge-to-edge mitral valve repair can be performed safely and a reduction in MR can be achieved in a significant proportion of patients to six months. Patients who required subsequent surgery had elective mitral valve repair or intended replacement.
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Indications for the transseptal approach to the left side of the heart have recently broadened, as it provides a therapeutic access for both left-sided catheter ablation and also percutaneous transvenous valvular intervention. Despite rising demand for transseptal procedures, the technique and device used for this purpose have remained essentially unchanged over the past 4 decades. The possibilities of failure of puncturing distorted and thickened atrial septal tissue or risks of complications related to cardiac perforation remain limitations of the technique. A new radiofrequency catheter provides an alternative approach to create a controlled transseptal perforation. We applied this technique to a series of patients and evaluated its feasibility as an alternative to conventional transseptal needle puncture.
Percutaneous balloon aortic valvuloplasty (BAV) has been limited predominantly to a palliative treatment for poor surgical candidates with critical aortic stenosis and multiple high-risk or comorbid conditions. The most commonly used technique for BAV is the retrograde approach, in which the balloon is passed via the femoral artery using 12-14 Fr sheaths. We compared an antegrade transseptal approach using the Inoue balloon vs. the retrograde transarterial approach using conventional balloons. The antegrade group had an improved acute hemodynamic outcome, including 20% additional increase of aortic valve area and 20% greater reduction of transaortic valve gradient compared to the retrograde approach. Preclosure with the Perclose device was used for the 14 Fr venous access sites, resulting in immediate hemostasis, minimizing the need for transfusion, and diminishing the period of bed rest. The improved acute efficacy and relative ease of venous access for the antegrade approach facilitate BAV by eliminating the need for large-caliber arterial access sheaths. The antegrade approach also incorporates technical elements necessary for percutaneous aortic valve replacement and may have expanded applications as an adjunct to this developing therapy. The impact of improved acute results on the long-term clinical outcome for this patient group will require further study.
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PURPOSE: Almost 50,000 mitral valve operations are performed annually in the United States, with an increasing number of repairs. Recently, a percutaneous mitral valve repair option that achieves edge-to-edge approximation with a clip has been described in patients with mitral regurgitation. DESCRIPTION: We describe 6 patients from three centers with mitral regurgitation after percutaneous repair who underwent reintervention. During open surgical revision, the clips were uneventfully removed in all patients with no limitation in surgical options. Five patients underwent repair and 1 underwent replacement. EVALUATION: After surgical revision, mitral regurgitation was significantly decreased, and all but 1 patient underwent uneventful recovery. One patient developed ilio-femoral deep venous thrombosis that was treated successfully with anticoagulation. CONCLUSIONS: Preserving standard of care options is critical with any evolving technology in the event of initial treatment failure. Standard surgical options were preserved in all of the patients who underwent percutaneous mitral valve edge-to-edge repair. Furthermore, a thorough understanding of the clip design, in particular its unlocking mechanism, is essential and facilitates surgical clip removal.
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