Transcatheter CoreValve valve-in-valve implantation in a stentless porcine aortic valve for severe aortic regurgitation.
Clinical case reports
2014; 2 (6): 281-285
APPOSITION V: STENTYS coronary stent system clinical trial in subjects with ST-segment elevation myocardial infarction--rationale and design.
American heart journal
2014; 168 (5): 652-660
We describe the first valve-in-valve Corevalve transcatheter aortic valve replacement in the St. Jude Toronto stentless porcine aortic valve in the United States, which enabled this 59-year-old patient with a history of bacterial endocarditis and aortic regurgitation to avoid heart transplant with complete resolution of his severe left ventricular dysfunction.
View details for DOI 10.1002/ccr3.113
View details for PubMedID 25548631
APPOSITION V: STENTYS coronary stent system clinical trial in subjects with ST-segment elevation myocardial infarction-Rationale and design
AMERICAN HEART JOURNAL
2014; 168 (5): 652-660
Targeted vascular drug delivery. A new day for an old way
2013; 55 (4): 353-361
Primary percutaneous coronary intervention (PCI) has considerably improved clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) when compared with thrombolytic therapy. Prognosis after primary PCI might be further improved by decreasing stent-related complications such as stent thrombosis. The STENTYS self-apposing stent has been shown to be superior compared with balloon-expandable stents with regard to stent apposition. The current prospective randomized trial was designed to evaluate whether the superior stent apposition of the STENTYS stent results in clinical outcomes that are at least noninferior to a conventional balloon-expandable stent.The APPOSITION V is a prospective, multicenter, international, single-blinded, randomized controlled trial in STEMI patients. Randomization will be performed in a 2:1 ratio between the self-apposing nitinol bare-metal STENTYS stent and the balloon-expandable bare-metal MULTI-LINK. The primary end point is defined as target vessel failure, which is a composite of cardiac death, target vessel-related recurrent myocardial infarction, or clinically driven target vessel revascularization, at 1-year follow-up. Baseline intravascular ultrasound and optical coherence tomography (OCT) substudies will be performed in 212 and 60 subjects, respectively, and a repeat angiography at 12 to 13 months will be performed in 105 subjects, including intravascular ultrasound and OCT (in the 60 OCT patients). This study is registered on ClinicalTrials.gov with number NCT01732341.APPOSITION V will be the first randomized trial powered on clinical end points that directly compares the STENTYS self-apposing stent with a conventional balloon-expandable stent in patients presenting with STEMI undergoing primary PCI.
View details for DOI 10.1016/j.ahj.2014.07.011
View details for PubMedID 25440792
A novel bioresorbable polymer paclitaxel-eluting stent for the treatment of single and multivessel coronary disease
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
2008; 51 (16): 1543-1552
Local drug delivery for the treatment of vascular disease has been studied for many years. In coronary artery disease, drug eluting stents are routinely deployed. However, with concerns regarding late thrombosis, and clinical applications where stenting is not desirable, such as peripheral vascular disease, a new direction to "leave nothing behind" has emerged. In Europe, paclitaxel-coated balloons have shown promise in reducing restenosis in both peripheral and coronary applications. However, a number of technical, economic and regulatory limitations of the current devices have been identified. Local or targeted fluid delivery of drugs may offer a relatively simple solution.
View details for Web of Science ID 000332347400005
View details for PubMedID 24434344
Novel stent and delivery systems for the treatment of bifurcation lesions: porcine coronary artery model.
Cardiovascular revascularization medicine : including molecular interventions
2007; 8 (1): 38-42
The aim was to compare safety and effectiveness of the CoStar drug-eluting stent (DES) (Conor MedSystems, Menlo Park, California) with those of the Taxus DES (Boston Scientific, Maple Grove, Minnesota) in de novo single- and multivessel percutaneous coronary intervention (PCI).Paclitaxel elution from a stent coated with biostable polymer (Taxus) reduces restenosis after PCI. The CoStar DES is a novel stent with laser-cut reservoirs containing bioresorbable polymer loaded to elute 10 microg paclitaxel/30 days.Patients undergoing PCI for a single target lesion per vessel in up to 3 native epicardial vessels were randomly assigned 3:2 to CoStar or Taxus. Primary end point was 8-month major adverse cardiac events (MACE), defined as adjudicated death, myocardial infarction (MI), or clinically driven target vessel revascularization (TVR). Protocol-specified 9-month angiographic follow-up included 457 vessels in 286 patients.Of the 1,700 patients enrolled, 1,675 (98.5%) were evaluable (CoStar = 989; Taxus = 686), including 1,330 (79%) single-vessel and 345 (21%) multivessel PCI. The MACE rate at 8 months was 11.0% for CoStar versus 6.9% for Taxus (p < 0.005), including adjudicated death (0.5% vs. 0.7%, respectively), MI (3.4% vs. 2.4%, respectively), and TVR (8.1% vs. 4.3%, respectively). Per-vessel 9-month in-segment late loss was 0.49 mm with CoStar and 0.18 mm with Taxus (p < 0.0001). Findings were consistent across pre-specified subgroups.The CoStar DES is not noninferior to the Taxus DES based on per-patient clinical and per-vessel angiographic analyses. The relative benefit of Taxus is primarily attributable to reduction in TVR. Follow-up to 9 months showed no apparent difference in death, MI, or stent thrombosis rates.
View details for DOI 10.1016/j.jacc.2008.01.020
View details for Web of Science ID 000255353200003
View details for PubMedID 18420096
Comparison of the efficacy of direct coronary stenting with sirolimus-eluting stents versus stenting with predilation by intravascular ultrasound imaging (from the DIRECT trial)
AMERICAN JOURNAL OF CARDIOLOGY
2006; 98 (11): 1464-1467
In percutaneous treatment of bifurcation coronary lesions, side-branch restenosis remains a significant limitation in current therapeutic approaches. Coronary stents with a side aperture and a sleeve may be clinically advantageous to maintain access to side branch, stabilize the side-branch orifice, and deliver the appropriate drug to the side-branch ostium.A novel stent system (PETAL stent; Advanced Stent Technologies, Pleasanton, CA), incorporating a side aperture with deployable struts, was compared within porcine coronary model to the prior stent version having only the side aperture (SLK-View stent). In six pigs, each stent was implanted either in the left anterior descending coronary artery or the left circumflex coronary artery with adjunctive kissing balloon dilatation. At 28-day follow-up, coronary angiography was performed.A total of six SLK-View stents and six PETAL stents were implanted in coronary arteries without any complication, and adjunctive kissing balloon dilatations were successful in all lesions. Quantitative coronary angiography (QCA) data at 28 days showed that PETAL stents exhibited superior QCA in mean diameter compared with SLK-View stents for side branch, inferring efficacy of PETAL ostial struts.AST-PETAL stent has the potential to be a new solution for treatment of bifurcation lesions. Antirestenosis drug elution should be considered with this successful platform.
View details for PubMedID 17293267
INFLUENCE OF MITRAL-VALVE MORPHOLOGY ON MITRAL BALLOON COMMISSUROTOMY - IMMEDIATE AND 6-MONTH RESULTS FROM THE NHLBI BALLOON VALVULOPLASTY REGISTRY
AMERICAN HEART JOURNAL
1992; 124 (3): 657-665
THROMBOEMBOLIC COMPLICATIONS OF PERCUTANEOUS TRANS-LUMINAL CORONARY ANGIOPLASTY FOR MYOCARDIAL-INFARCTION
CATHETERIZATION AND CARDIOVASCULAR DIAGNOSIS
1987; 13 (2): 100-106
A direct coronary stenting technique using drug-eluting stents may decrease drug-eluting stent efficacy due to possible damage to the surface coating of the stent. The DIRECT is a multicenter, prospective, nonrandomized trial designed to evaluate the direct stenting strategy for the sirolimus-eluting Bx-Velocity stent compared with the historical control (SIRIUS trial, stenting with predilation). Volumetric and cross-sectional intravascular ultrasound analyses at 8-month follow-up were performed in 115 patients (DIRECT n= 64, control n = 51). Patient and lesion characteristics were comparable between groups. The DIRECT group achieved an equivalent uniform expansion index, defined as minimum stent area/maximum stent area x 100, compared with the control group (65.9 +/- 11.7 vs 63.1 +/- 12.7, p = NS). At 8-month follow-up, vessel, stent, lumen, and neointimal volume index (volume in cubic millimeters/length in millimeters) and percent neointimal volume were similar between the DIRECT and control groups (vessel volume index 13.9 +/- 4.40 vs 15.0 +/- 3.83; stent volume index 6.83 +/- 2.02 vs 6.94 +/- 2.04; lumen volume index 6.71 +/- 2.04 vs 6.81 +/- 2.07; neointimal volume index 0.14 +/- 0.24 vs 0.16 +/- 0.23; percent neointimal volume 3.73 +/- 6.97 vs 3.14 +/- 5.32, p = NS for all). In addition, in-stent neointimal hyperplasia distribution was significantly smaller near the distal stent edge (0.22 vs 0.098 mm(3)/mm, p = 0.01 for an average neointimal volume index within 3 mm from the distal stent edge). In conclusion, direct coronary stenting with the sirolimus-eluting Bx-Velocity stent is equally effective in terms of uniform stent expansion and long-term quantitative intravascular ultrasound results compared with conventional stenting using predilation. This strategy appears to be associated with less neointimal hyperplasia near the distal stent edge.
View details for DOI 10.1016/j.amjcard.2006.06.046
View details for Web of Science ID 000242595300010
View details for PubMedID 17126651
THE ANGIOGRAPHY PROGRAM AT STANFORD
NUCLEAR INSTRUMENTS & METHODS IN PHYSICS RESEARCH SECTION A-ACCELERATORS SPECTROMETERS DETECTORS AND ASSOCIATED EQUIPMENT
1986; 246 (1-3): 719-725
PROSPECTS FOR NON-INVASIVE ANGIOGRAPHY WITH TUNABLE X-RAYS
NUCLEAR INSTRUMENTS & METHODS IN PHYSICS RESEARCH SECTION B-BEAM INTERACTIONS WITH MATERIALS AND ATOMS
1985; 10-1 (MAY): 323-328
REDUCTION OF ISCHEMIC DEPOLARIZATION BY THE CALCIUM-CHANNEL BLOCKER DILTIAZEM - CORRELATION WITH IMPROVEMENT OF VENTRICULAR CONDUCTION AND EARLY ARRHYTHMIAS IN THE DOG
1984; 54 (1): 10-20
To determine the incidence of thromboembolic complications of percutaneous transluminal coronary angioplasty (PTCA) in the setting of recent and acute myocardial infarction, the clinical sequelae and coronary angiographic findings were examined in a series of 13 patients who underwent PTCA either as acute intervention during the infarction or as treatment for recurrent myocardial ischemia that occurred soon after the initial completed infarction. In all cases, the angiographic appearance in the infarct-related artery was that of thrombus in the setting of total or subtotal occlusion. Balloon dilatation without antecedent thrombolytic therapy, was performed in 14 arteries and was successful in establishing reperfusion with reduction of the degree of intraluminal narrowing to less than 50% in all cases. Residual thrombus at the site of inflation was noted in two cases (15%), and embolization was noted in four cases (29%), for an incidence of complication of 44%. In five of six instances in which either residual thrombus or embolization were noted, the initial infarction had occurred greater than 24 h before. In only one of seven cases in which PTCA was used as acute intervention during infarction of less than 4 h duration was the presence of residual thrombus noted after PTCA. Therefore, these findings suggest that thromboembolic complications after PTCA in the setting of recent or acute myocardial infarction are uncommon when the syndrome is less than 4 h duration; however, complications are relatively frequent when infarction has occurred greater than 24 h before. PTCA as a primary intervention in this latter setting should be approached cautiously.
View details for Web of Science ID A1987G788900004
View details for PubMedID 2953429
Calcium channel blockers suppress early ischemic arrhythmias, possibly by diminishing intracellular calcium overload and its effect on the ventricular action potential. To explore this, we compared the effects of diltiazem on ischemic "injury" potentials and ventricular fibrillation during serial coronary artery occlusions in dogs. Injury potentials and ventricular fibrillation were elicited every 15-25 minutes by simultaneous occlusion of the left anterior descending and circumflex arteries during rapid atrial pacing. DC epicardial electrograms were recorded differentially between the ischemic region and a small nonischemic region supplied by a proximal branch of the left anterior descending artery. Injury potentials developed with a uniform time course during five control occlusions, but were reduced by diltiazem infusion (0.5 mg/kg over 25 minutes) in each of eight dogs. The mean diastolic injury potential (T-Q depression) at 150 seconds of ischemia was 9.1 +/- 2.7 mV before diltiazem and 6.1 +/- 1.6 mV afterward (P less than 0.001). Diltiazem increased the mean time between coronary occlusion and ventricular fibrillation from 186 to 366 seconds (P less than 10(-5), but did not change the magnitude of the diastolic injury potential at onset of ventricular fibrillation. Diltiazem also delayed ischemia-induced conduction impairment to the same extent that it delayed injury potential development. In five dogs, the effect of diltiazem on regional blood flow near the epicardial electrodes was measured by infusion of radionuclide-labeled microspheres. Coronary occlusion reduced flow to the ischemic zone from 0.86 to 0.05 ml/min per g (P = 0.001). Diltiazem increased preocclusion flow by 11% (P = 0.03), but did not significantly alter flow during occlusion. Hemodynamic measurements show that diltiazem did not diminish cardiac work. Diltiazem therefore produced a flow-independent reduction of cellular depolarization during ischemia, which may be due to relief of calcium overload, and which may explain the antifibrillatory effect.
View details for Web of Science ID A1984SB78500002
View details for PubMedID 6692497