First percutaneous transcatheter aortic valve-in-valve implant with three year follow-up.

OBJECTIVES: This study was conducted to report the clinical, hemodynamic, and iconographic outcomes of the longest survivor of the global CoreValve experience. BACKGROUND: Early results of percutaneous heart valve (PHV) implantation for severe symptomatic aortic stenosis (AS) have been encouraging, with mid term survival up to 2 years; however longer durability term is unknown. Although a PHV has been implanted in a degenerated surgical bioprosthesis, the feasibility of a PHV-in-PHV has not been demonstrated. METHODS: A patient with severe refractory heart failure due to severe aortic regurgitation (AR) and moderate AS, underwent CoreValve prosthesis implantation. The PHV was deployed too proximal into the left ventricular outflow tract, resulting in severe AR through the frame struts. Using the first PHV as a landmark, a second CoreValve was then deployed slightly distal to the first, with trivial residual paravalvular leak. RESULTS: The second CoreValve expanded well with proper function. Transvalvular gradient was 8 mmHg. Both coronary ostia were patent. New mild to moderate mitral regurgitation occurred due to impingement of the anterior mitral leaflet by the first PHV. NYHA functional class improved from IV to II, maintained over the past 3 years. Echocardiography at 3 years showed normal functioning CoreValve-in-CoreValve prostheses, without AR or paravalvular leaks. Transvalvular gradient was 10 mmHg. Cardiac CT showed stable valve-in-valve protheses with no migration. CONCLUSION: The CoreValve prosthesis has maintained proper function up to 3 years, with no structural deterioration or migration. Treating mixed aortic valve disease with predominant AR is feasible. The concept as well as durability of the first PHV-in-PHV has also been demonstrated.

First human case of retrograde transcatheter implantation of an aortic valve prosthesis.

The transcatheter route is an emerging approach to treating valvular disease in high-risk patients. The 1st clinical antegrade transcatheter placement of an aortic valve prosthesis was reported in 2002. We describe the first retrograde transcatheter implantation of a new aortic valve prosthesis, in a 62-year-old man with inoperable calcific aortic stenosis and multiple severe comorbidities. Via the right femoral artery, a Cook introducer was advanced into the abdominal aorta. The aortic valve was crossed with a straight wire, and a pigtail catheter was advanced into the left ventricle to obtain pressure-gradient and anatomic measurements. An 18-mm valvuloplasty balloon was then used to predilate the aortic valve. Initial attempts to position the prosthetic valve caused a transient cardiac arrest. Implantation was achieved by superimposing the right coronary angiogram onto fluoroscopic landmarks in the same radiographic plane. A balloon-expandable frame was used to deliver the valve. After device implantation, the transvalvular gradient was <5 mmHg. The cardiac output increased from 1 to 5 L/min, and urine production increased to 200 mL/h. The patient was extubated on the 2nd postimplant day. Twelve hours later, he had to be reintubated because of respiratory distress and high pulmonary pressures. His condition deteriorated, and he died of biventricular failure and refractory hypotension on day 5. Despite the severe hypotension, valve function was satisfactory on echo-Doppler evaluation. In our patient, retrograde transcatheter implantation of a prosthetic aortic valve yielded excellent hemodynamic results and paved the way for further use of this technique in selected high-risk patients.

Safety and feasibility of acute percutaneous septal sinus shortening: first-in-human experience.

BACKGROUND: Multiple percutaneous therapies for the treatment of functional and ischemic mitral regurgitation (FMR/IMR) are under development. We previously reported a novel percutaneous technique, the percutaneous septal sinus shortening [PS(3)] System which was effective in ameliorating FMR in an animal model. We herein report results from the first-in-human safety and feasibility pilot study involving the PS(3) System. METHODS AND RESULTS: The primary objective of this first-in-human study was to evaluate the safety and feasibility of acute percutaneous septal-lateral shortening by using the PS(3) System in patients immediately prior to clinically-indicated surgical mitral valve repair. Two patients were enrolled. Patient One had severe aortic insufficiency with moderate functional mitral regurgitation. The PS(3) System reduced the MR grade from 2+ to 1+ with a decrease in the mean septal-lateral systolic (SLS) dimension from 38 to 27 mm (29% reduction). Patient Two had severe ischemic mitral regurgitation in the setting of severe multi-vessel disease and prior infero-posterior infarct. MR grade was reduced from 3+ to 1+ with a decrease in the mean SLS dimension from 36 to 25mm (31% reduction). There were no procedural complications and both patients proceeded to pre-planned cardiac surgery, where the devices were explanted under direct visualization. CONCLUSIONS: The PS(3) System has been safely translated from the preclinical setting to first-in-human implantation. Both patients studied experienced a reduction in MR after device implantation, with significant SLS shortening. Further clinical trials will be needed to assess long-term efficacy and durability.

Acute and long-term outcomes of the novel side access (SLK-View) stent for bifurcation coronary lesions: a multicenter nonrandomized feasibility study.

OBJECTIVE: To evaluate technical feasibility and procedural safety of SLK-View stent for treating bifurcation lesions. BACKGROUND: Percutaneous treatment of coronary bifurcation lesions represents a technical challenge. Several stenting techniques and dedicated devices have proven unsuccessful, with high rates of side branch occlusion at index procedure and follow-up. METHODS: Eighty one patients with 84 de novo coronary artery lesions involving a major side branch underwent SLK-View (Advanced Stent Technologies, Inc., Pleasanton, CA) stent implantation with subsequent kissing balloon post dilatation. SLK-View stent is a new scaffolding device incorporating a side aperture that allows access to the side-branch of a bifurcation after deployment of the stent in main vessel. All patients underwent angiographic follow-up at 6 months. Procedural, in-hospital, and 6-month follow-up outcomes were examined. RESULTS: The lesions were located in left main (n = 11), left anterior descending (n = 50), left circumflex (n = 8), right coronary artery (n = 7), and 1 ramus intermedius. The most frequent lesions (44.1%) were true bifurcations. Successful stent delivery to bifurcation was accomplished in 82/84 of the cases (97.6%). Technical success was obtained in 99 and 94% of main vessel and side branches, respectively. Stenting in side-branch was performed in 21 lesions (25%). Side-branches were accessed effectively in 100% of bifurcations postprocedurally. Binary restenosis rate at 6-month follow-up was 28.3% and 37.7% for main vessel and side-branch, respectively. TLR rate at 6-month follow-up was 21% and CABG rate of 6%. CONCLUSION: In this consecutive multicenter series of patients with coronary bifurcation lesions, this novel side-branch access stent proved feasible, with a high procedural success rate, while maintaining side-branch access.

Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST Phase I Clinical Trial.

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.

One-year clinical outcome of various doses and pharmacokinetic release formulations of paclitaxel eluted from an erodable polymer - Insight in the Paclitaxel In-Stent Controlled Elution Study (PISCES).

AIMS: The one year clinical benefit of various doses and release durations of paclitaxel eluted from an erodable polymer has not been evaluated so far. METHODS AND RESULTS: Conor paclitaxel-eluting stents have intra-stent wells in which drug and polymer are deposited. Stents with six different release formulations (dose: 10 microg or 30 microg, duration: 5, 10 or 30 days, direction: mural or bidirectional) were implanted in 6 patient cohorts. Clinical follow-up was conducted at 4 and 12 months. Quantitative angiography and IVUS were performed at 4 months, and additional angiographic and IVUS follow-up were performed for groups D5 (10microg/30days/mural) and D6 (30microg/30days/mural), as they had shown the most favorable results at 4 months. At one year, the lowest major adverse cardiac event rates were observed in the slow release (30 day) group (5.1% in D5 and 6.9% in D6). One-year in-stent late loss was 0.52+/-0.34 mm in D5 and 0.36+/-0.50mm in D6 (p=0.20) while neointimal area was 0.99+/-0.54 mm2 in D5 and 0.77+/-0.92 mm2 in D6 (p=0.42). Corresponding in-stent binary restenosis at one year was 0% and 5.6% respectively (p=0.36). CONCLUSIONS: Patients who received the slow release formulation stent had better clinical outcome at one year than those who received the fast release formulation. However, the effect on neointimal suppression requires investigation in a larger population to determine whether the high dose formulation confers an additional clinical benefit.

Five-year clinical and angiographic follow-up after intracoronary iridium-192 radiation therapy.

BACKGROUND: Ionizing gamma radiation has been shown to reduce neointimal formation and the incidence of restenosis after balloon angioplasty and stenting in clinical trials. However, the long-term effects of this therapy are unknown. The first cohort of patients to receive intracoronary gamma radiation after balloon angioplasty for the prevention of restenosis have completed a 5-year angiographic and clinical follow-up. The outcome of these patients is presented and discussed. METHODS: Twenty-one patients with unstable angina (22 arteries) underwent standard balloon angioplasty. Intracoronary radiation therapy was performed immediately after the intervention using an Iridium-192 source wire hand-delivered to the angioplasty site. All patients were followed clinically and Quantitative Coronary Analysis (QCA) was performed at 6, 24, 36 and 60 months. RESULTS: Target lesion revascularization occurred in six lesions, three of which were total occlusions (two early within 30 days and one occurred at 2 years), and one patient had a myocardial infarction attributable to a nontarget vessel. Serial QCA detected a binary restenosis rate of 28.6% (n=6) at 6 months. The late loss (0.29 mm) and loss index (0.25) remained low at 2, 3 and 5 years. Angiographic complications included four aneurysms (two procedure related and two occurring within 3 months). At 2 years, only one aneurysm increased in size (46 vs. 27 mm(2)); and at 3 and 5 years, all aneurysms remained unchanged. No other angiographic complications were observed. CONCLUSION: The early clinical and angiographic effects of intracoronary gamma radiation were maintained at 5 years without further increase in the aneurysm formation or apparent new adverse effects related to the radiation therapy between 2 and 5 years.