-
[show abstract]
[hide abstract]
ABSTRACT: To describe a new approach to percutaneous mitral valve repair and an illustrative first-in-man experience, we introduce a suture mediated "double orifice", "edge-to-edge" procedure which can be an effective surgical therapy for mitral regurgitation (MR) in selected patient.
We describe a novel percutaneous approach to double orifice mitral repair utilising an intra-cardiac suture based system. The procedure was performed in 15 patients in four international centres. Endovascular suture based double orifice mitral repair was feasible with an acute reduction in the severity of MR by > or = 1 grade in nine of 15 patients. At 30 days improvement in MR appeared durable in six patients. Clinical utility was limited by technical difficulties, the inadequacies of current imaging modalities and suture dehiscence.
Percutaneous endovascular suture based cardiac repair is feasible. However, in utilising the current device clinical benefit was limited and the repair not durable. In the future, similar endovascular approaches may enable more complex cardiac repair.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 06/2009; 5(1):86-9. · 3.29 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: The left atrial appendage (LAA) is a cardiac structure with unique anatomic and functional features. It is significantly more than a simple chamber appended to the left atrium (LA), differing from the LA in structure, function, and hormonal activity. Unfortunately, it is the source of more than 90% of cardiac-based emboli, particularly in atrial fibrillation, mandating lifelong anticoagulation. Percutaneous LAA exclusion was developed to limit or eliminate cardioembolic events in patients with atrial fibrillation. Benign healing of the appendage occurs without adverse hemodynamic effects, and with no residual surface thrombus or tissue damage. The feasibility of this treatment is now established, suggesting that percutaneous therapy is safe, practical and possibly effective to eliminate the need for anticoagulation and significantly reduce cardioembolic events.
Catheterization and Cardiovascular Interventions 02/2009; 74(2):234-42. · 2.29 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: To compare the effects of sirolimus-eluting (SES) versus bare metal stents (BMS) on 6-month in-stent late luminal loss (LLL) and 1-year major adverse cardiac events (MACE) in diabetics undergoing percutaneous coronary interventions.
In studies of unselected patients, coronary restenosis rates have been lower with SES than with BMS. Comparisons of SES versus BMS in diabetics with more than one stenosis or more than one vessel disease are few.
This open-label trial randomly assigned 200 diabetics with de novo coronary artery stenoses to receive up to three SES versus BMS in a 2:1 ratio. The patients underwent repeat coronary angiography at 6 months after the index procedure and were followed-up for 1 year. The primary study endpoint was in-stent LLL at 6 months.
Between August 2002 and May 2004, 83 patients (mean age = 60 years) with 128 lesions (mean = 1.5 per patient) were enrolled at four U.S. and seven Asian medical centers. Enrollment was terminated early by the Safety Monitoring Board because of a statistically significant difference in rates of clinical endpoints. The mean in-stent LLL at 6 months was 0.23 mm in SES versus 1.10 mm in BMS recipients (P < 0.001). At 12 months, 8 patients (15%) assigned to SES had experienced MACE versus 12 patients (41%) assigned to BMS (P = 0.006).
In diabetics, the mean 6-month in-stent LLL was significantly smaller, and 12-month MACE rate significantly lower, after myocardial revascularization with SES than with BMS.
Catheterization and Cardiovascular Interventions 10/2008; 72(5):591-600. · 2.29 Impact Factor
-
Mitchell W Krucoff,
Dean J Kereiakes,
John L Petersen,
Roxana Mehran,
Vic Hasselblad,
Alexandra J Lansky,
Peter J Fitzgerald,
Jyotsna Garg,
Mark A Turco,
Charles A Simonton,
Stefan Verheye,
Christophe L Dubois,
Roger Gammon,
Wayne B Batchelor,
Charles D O'Shaughnessy,
James B Hermiller,
Joachim Schofer, Maurice Buchbinder,
William Wijns
[show abstract]
[hide abstract]
ABSTRACT: 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.
Journal of the American College of Cardiology 04/2008; 51(16):1543-52. · 14.16 Impact Factor
-
Dean J Kereiakes,
Paul S Teirstein,
Ian J Sarembock,
David R Holmes,
Mitchell W Krucoff,
William W O'Neill,
Ron Waksman,
David O Williams,
Jeffrey J Popma, Maurice Buchbinder,
Roxana Mehran,
Ian T Meredith,
Jeffrey W Moses,
Gregg W Stone
[show abstract]
[hide abstract]
ABSTRACT: Percutaneous coronary intervention (PCI) has played an integral role in the therapeutic management strategies for patients who present with either acute coronary syndromes or stable angina pectoris. The COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial enrolled patients with chronic stable angina and at least 1 significant (> or =70%) angiographic coronary stenosis who were randomly assigned to an initial treatment of either PCI in conjunction with optimal medical therapy or optimal medical therapy alone. Although the initial management strategy of PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events, improvement in angina-free status and a reduction in the requirement for subsequent revascularization was observed. An in-depth analysis of the COURAGE trial design and execution is provided.
Journal of the American College of Cardiology 10/2007; 50(16):1598-603. · 14.16 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: The edge-to-edge (Alfieri) technique for mitral valve repair is a versatile method of treating mitral insufficiency. Because of its simplicity, it has been applied in minimally invasive surgery, and recently, in the design of endovascular closed-heart devices.
The purpose of this study was to evaluate the acute in-vivo safety and feasibility of a novel percutaneous mitral valve repair system based on Alfieri technique in an animal model.
Under general anesthesia, 11 pigs (90-100 kgs), underwent percutaneous Alfeiri procedure. The right femoral vein was punctured and the mitral valve was approached via a standard transeptal puncture. Combined intracardiac echo and fluoroscopic guidance was used. The procedure included: the positioning of a guide catheter for multiple access to the left atrium and for directing devices; the use of a therapy device to capture the free edge of the mitral valve leaflets using vacuum, and to deliver the suture to the valve and finally the fixation with a Nitinol suture clip, and trimming of the suture with a fastener catheter.
Leaflet capture, suture placement, and suture-clip deployment was successful in all 11 animals. There were no acute cardiac or access site complications. Procedural time (from wire in left atrium to completion of the procedure was 18 +/- 9 min (range 9-30 min). Blood loss was 67 +/- 44 ml (range 0-125 ml). A double orifice configuration was visible by echocardiography at the end of the procedure in all animals.
This acute animal study demonstrated the feasibility of a beating heart percutaneous Alfieri procedure in a non-diseased porcine valve using an endovascular suturing device to safely access the mitral valve, place a stitch through the mitral valve leaflets, and deploy a suture-clip that reproduces the surgical technique. Clinical application of this device in humans needs to be evaluated.
Catheterization and Cardiovascular Interventions 04/2007; 69(4):525-31. · 2.29 Impact Factor
-
Atsushi Hirohata,
Yoshihiro Morino,
Junya Ako,
Ryota Sakurai, Maurice Buchbinder,
Ronald P Caputo,
Steven P Karas,
Gregory J Mishkel,
Michael R Mooney,
Charles D O'shaughnessy,
Albert E Raizner,
Robert L Wilensky,
David O Williams,
Shing-Chiu Wong,
Paul G Yock,
Yasuhiro Honda,
Jeffrey W Moses,
Peter J Fitzgerald
[show abstract]
[hide abstract]
ABSTRACT: 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.
The American Journal of Cardiology 01/2007; 98(11):1464-7. · 3.37 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: The purpose of this study was to evaluate the clinical and angiographic outcomes of the Symbiot ePTFE covered stent versus bare metal stents (BMS) for the treatment of saphenous vein graft (SVG) disease.
The Symbiot stent was developed to reduce periprocedural complications, by potentially preventing distal embolization, and to serve as a possible barrier to cell migration, thus reducing restenosis.
Symbiot III is a prospective, randomized trial of 400 patients at 45 US sites, with 201 patients in the Symbiot group and 199 in the BMS group. Randomization was stratified based on the intended use of embolic protection devices and glycoprotein IIb/IIIa inhibitors. The primary endpoint was percent diameter stenosis (%DS) as measured by quantitative coronary angiography at 8 months. Secondary endpoints included MACE (cardiac death, MI, TVR).
The groups were well matched for all baseline clinical and lesion characteristics. At 8 months, %DS was comparable between groups (30.9% Symbiot, 31.9% BMS, P = 0.80). Although the rates of binary restenosis in the stented segment were similar (29.1% Symbiot, 21.9% BMS, P = 0.17), more patients in the Symbiot group had binary restenosis at the proximal edge (9.0% Symbiot, 1.8% BMS, P = 0.0211). There was no difference in the incidence of MACE between groups (30.6% Symbiot, 26.6% BMS, P = 0.43).
This study failed to show an advantage for the Symbiot stent in the treatment of degenerated SVGs. This PTFE covered stent does not appear to act as a barrier to prevent restenosis.
Catheterization and Cardiovascular Interventions 10/2006; 68(3):379-88. · 2.29 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: High-quality live imaging assessment of cardiac valves and cardiac anatomy is crucial for the success of percutaneous catheter-based mitral valve (MV) repair techniques. We examined the use of intracardiac echocardiography (ICE) in providing online ICE images necessary for successful perctunaneous MV repair by Alfieri stitch technique-based percutaneous edge-to-edge device in a swine model.
ICE was performed in 20 healthy adult pigs (90 +/- 8 kg, mean +/- SEM). A 10F ICE catheter was advanced through the left femoral vein and the right jugular vein. Images were obtained from the right atrium, left atrium, right ventricle, and pulmonary artery. Fluoroscopy was used to locate the position of ICE catheter tip in different imaging windows.
An echocardiographic protocol was developed for focused visualization of target cardiac structures during the process of percutaneous MV repair. This included visualization of interatrial septum to guide transeptal puncture; to confirm transit of guidewire into the left atrium, across the MV into the left ventricle and across the aortic valve into the aorta; to assist in central positioning of guide catheter in the left atrium above and then across MV leaflets; and to visualize middle scallops of anterior and posterior MV leaflets in short- and long-axis views. Finally, location and orientation of the orifice of the therapy catheter against each MV leaflet was visualized to enable successful capture of MV leaflets, to confirm successful deployment of suture and double orifice (figure of 8" appearance of MV, and finally to confirm central deployment of clip at the site of suture.
An ICE protocol was developed to visualize serial cardiac structures to guide deployment of suture into the A2-P2 scallops of the MV and to confirm final result before release of clip.
Journal of the American Society of Echocardiography: official publication of the American Society of Echocardiography 03/2006; 19(2):147-53. · 2.98 Impact Factor
-
S Chiu Wong,
Mun K Hong,
Stephen G Ellis, Maurice Buchbinder,
Mark Reisman,
Augustin DeLago,
Mirle Kellett,
Jeffrey J Popma,
Mary E Russell,
Roxana Mehran,
Jeffrey W Moses,
Gregg W Stone
[show abstract]
[hide abstract]
ABSTRACT: Longer bare metal stent lengths have been associated with greater restenosis. However, the effect of the ratio of stent length to lesion length on clinical and angiographic restenosis after implantation of bare metal and drug-eluting stents has not been clearly defined. Patients in the TAXUS-IV study who underwent single-study stent placement were categorized into tertiles based on ratios of stent length to lesion length. Clinical results at 1 year and angiographic outcomes at 9 months were compared across the 3 groups. The median ratios of stent length to lesion length were 1.20, 1.58, and 2.27 in the 3 tertiles. Analysis segment restenosis rates at 9 months were similar across the 3 tertiles with bare metal stents (24.7% vs 26.7% vs 23.8%, respectively, p = 0.90 for trend) and paclitaxel-eluting stents (11.7% vs 6.5% vs 5.4%, respectively, p = 0.24). Similarly, there were no differences in 1-year rates of target lesion revascularization across the 3 tertiles for bare metal stents (14.6% vs 14.8% vs 13.7%, respectively, p = 0.91) or paclitaxel-eluting stents (6.1% vs 3.6% vs 4.0%, respectively, p = 0.38). By multivariate analysis, the ratio of stent length to lesion length was an independent predictor of neither 9-month angiographic restenosis nor 1-year target lesion revascularization in the bare metal stent arm (odds ratio 1.21, p = 0.36, and hazard ratio 0.80, p = 0.31, respectively) or in the paclitaxel-eluting stent arm (odds ratio 0.86, p = 0.76, and hazard ratio 0.58, p = 0.21, respectively). These data do not support the arbitrary use of larger ratios of stent length to lesion length in patients who undergo implantation of drug-eluting stents.
The American Journal of Cardiology 06/2005; 95(9):1043-8. · 3.37 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Calcified lesions are encountered with increasing frequency in the catheterization laboratory. Percutaneous coronary interventions of calcified lesions are associated with a higher complication rate than percutaneous intervention on non-calcified lesions. The review focuses on current management strategies in the drug eluting stent era of this complex lesion subset. Evidence based approaches to treat calcified coronary lesions with balloon based and atherectomy devices as adjunctive modalities in the drug eluting stent era are discussed in this article.
International Journal of Cardiovascular Interventions 02/2005; 7(4):199-204.
-
Issam Moussa,
Martin B Leon,
Donald S Baim,
William W O'Neill,
Jeffery J Popma, Maurice Buchbinder,
Jay Midwall,
Charles A Simonton,
Emily Keim,
Patrick Wang,
Richard E Kuntz,
Jeffrey W Moses
[show abstract]
[hide abstract]
ABSTRACT: Randomized clinical trials have shown that a sirolimus-eluting stent significantly reduces restenosis after percutaneous coronary revascularization. Diabetic patients are known to have a higher risk of restenosis compared with nondiabetic patients. The purpose of this analysis was to determine the impact of sirolimus-eluting stents on outcomes of diabetic compared with nondiabetic patients.
The SIRIUS (SIRolImUS-coated Bx Velocity balloon-expandable stent in the treatment of patients with de novo coronary artery lesions) trial is a randomized, double-blind study that compared sirolimus-eluting and bare metal stent implantation in 1058 patients with de novo native coronary artery lesions. Diabetes mellitus was present in 279 (26%) patients (diabetes mellitus group, 131 patients received sirolimus-eluting stents and 148 patients received bare metal stents) and was absent in 778 patients (no-diabetes mellitus group, 402 patients received sirolimus-eluting stents and 376 patients received bare metal stents). At 270 days, target lesion revascularization was reduced in diabetic patients from 22.3% with bare metal stents to 6.9% with sirolimus-eluting stents (P<0.001) and in nondiabetic patients from 14.1% to 2.99% (P<0.001), respectively. Major adverse cardiac events were reduced in diabetic patients from 25% with bare metal stents to 9.2% with sirolimus-eluting stents (P<0.001) and from 16.5% to 6.5% (P<0.001) in nondiabetic patients, respectively.
Implantation of sirolimus-eluting stents compared with bare metal stents in de novo coronary lesions reduces major adverse cardiac events in patients with and without diabetes mellitus. However, among patients receiving sirolimus-eluting stents, there remains a trend toward a higher frequency of repeat intervention in diabetic patients compared with nondiabetic patients, particularly in the insulin-requiring patients.
Circulation 06/2004; 109(19):2273-8. · 14.74 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Following successful angioplasty of 49 saphenous vein graft lesions, a novel, self-centering phosphorus-32 solid foil beta source encapsulated within a dual-balloon membrane was used to deliver 20 Gy 1 mm into the vessel wall. Clinical and angiographic recurrence rates at 12 months were low, especially in de novo lesions.
The American Journal of Cardiology 09/2003; 92(3):312-4. · 3.37 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: The optimum treatment of obstructive coronary disease in small (<3.0 mm diameter) arteries remains unknown. Rotational atherectomy is an approved treatment that might reduce the vascular injury during percutaneous coronary intervention compared with angioplasty. We report on a multicenter, randomized, blinded end point trial comparing rotational atherectomy with balloon angioplasty in the prevention of restenosis of obstructed small coronary arteries.
A total of 446 patients with myocardial ischemia associated with an angiographic stenosis in a native coronary artery 2 to 3 mm in diameter and < or =20 mm in length without severe calcification were randomly assigned to receive rotational atherectomy (n = 227) or balloon angioplasty (n = 219). The primary end point was target vessel failure at 12 months (defined as the composite of death, Q-wave myocardial infarction, and clinically driven repeat revascularization of the target vessel).
The mean reference vessel diameter was 2.46 +/- 0.40 mm, the mean lesion length was 9.97 +/- 5.59 mm, and the prevalence of diabetes mellitus was 32%. Acute procedural success (91.6% for rotational atherectomy, 94.1% for balloon angioplasty, P =.36) and target vessel failure at 12 months were not significantly different (30.5% vs 31.2%, P =.98). At 8 months, there were no significant differences in minimum lumen diameter (1.28 +/- 0.63 mm vs 1.19 +/- 0.54 mm, P =.26), percent diameter stenosis (28% +/- 12% vs 29% +/- 15%, P =.59), binary restenosis rate (50.5% vs 50.5%, P = 1.0), or late loss index (0.57 vs 0.62, P =.7). No Q-wave myocardial infarctions occurred in either arm of the study, and non-Q-wave myocardial infarctions (defined as creatine kinase level >2 times normal with an elevated creatine kinase-myocardial band isoenzyme level) occurred in 2.2% and 1.4% of the patients in the rotational atherectomy and balloon angioplasty groups, respectively (P =.72).
Rotational atherectomy was found to be safe in the treatment of obstructed small arteries, but lower rates of target vessel failure were not achieved compared with balloon angioplasty. Because the acute gain and loss index ratios of the 2 treatments were similar, there was no evident beneficial antirestenosis mechanism seen for rotational atherectomy.
American heart journal 05/2003; 145(5):847-54. · 4.65 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Catheter-based intracoronary radiation therapy demonstrated reduction of the recurrence rate of in-stent restenosis by 35%-50% when compared to conventional therapy. The objectives of this study were to determine the safety and feasibility of a new balloon-shaped source design and a higher applied dose to reduce the restenosis rates. Thirty-two patients with in-stent restenosis who met study eligibility criteria were successfully treated with standard PCI techniques. Following a successful intervention, a P-32 beta-balloon source was positioned to cover the angioplasty site and a dose of a 20 Gy at 1 mm from the surface of the source was administered. The primary endpoint was a composite of major adverse cardiac events (any death, MI, emergent CABG, or repeat target vessel revascularization) during 6 months of follow-up. At 6 months, only one patient underwent repeat PTCA to the target vessel (3%). There were no instances of death, emergency surgery, late thrombosis, total occlusions, or MI. Binary restenosis measured by QCA at the stented segment was 0% and for the whole analysis vessel was 7.5%. Beta-radiation delivered with a balloon P-32 source design for patients with in-stent restenosis results in lower than expected rate of angiographic and clinical restenosis and the absence of late complications.
Catheterization and Cardiovascular Interventions 12/2002; 57(3):286-94. · 2.29 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: 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.
Cardiovascular Revascularization Medicine 8(1):38-42.
-
Indian heart journal 56(4):349-53.
