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ABSTRACT: The Edwards SAPIEN transcatheter heart valve (THV) is approved for aortic stenosis patients considered inoperable because of high surgical risk. Based on the high-risk arm of the PARTNER trial, the Food and Drug Administration's Circulatory System Devices Panel reviewed an additional indication for use in high-risk, operable patients. Although several concerns were raised regarding safety, trial misconduct, and several subgroup analyses, most panel members agreed that the Edwards SAPIEN THV (Edwards Lifesciences LLC, Irvine, CA), when used in high-risk patients, is noninferior to surgical aortic valve replacement. The panel voted 11 to 0 (with 1 abstention) that the benefits of the Edwards SAPIEN THV do outweigh the risks for use in the indicated patient population. This summary aims to describe the discussions and recommendations made during the meeting. Based on the panel recommendation, the device was approved by the Food and Drug Administration.
American heart journal 05/2013; 165(5):710-5. · 4.65 Impact Factor
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The Lancet 04/2013; · 38.28 Impact Factor
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04/2013; 6(4):427. · 1.07 Impact Factor
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American heart journal 02/2013; 165(2):e11. · 4.65 Impact Factor
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11/2012; 5(11):1106-7. · 1.07 Impact Factor
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ABSTRACT: Distal anastomotic lesions are the most common reason for venous and arterial graft failure. Redo coronary artery bypass surgery carries a higher risk for mortality and non-fatal myocardial infarction. Many operators therefore consider percutaneous coronary intervention as a good alternative for relieving angina symptoms in this subset of patients with anastomotic lesions. However, the best percutaneous method for treating these lesions is still controversial. Here we review reported data on the incidence, pathogenesis, and treatment of distal anastomotic lesions in both venous and arterial bypass grafts. © 2012 Wiley Periodicals, Inc.
Catheterization and Cardiovascular Interventions 08/2012; · 2.29 Impact Factor
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ABSTRACT: Patients undergoing transcatheter aortic valve replacement (TAVR) are at increased risk for acute kidney injury (AKI). The Valve Academic Research Consortium (VARC) recently published criteria for AKI after TAVR. We aimed to identify predictors, assess the prognostic impact of AKI after TAVR, and compare various criteria for AKI.
Patients with aortic stenosis undergoing TAVR were retrospectively analyzed for periprocedural AKI (<72 hours) according to the VARC definition (increase in serum creatinine ≥0.3 mg/dL or ≥1.5× baseline) or according to the modified Risk, Injury, Failure, Loss, and End-stage kidney disease (RIFLE) criteria (decrease of >25% in estimated glomerular filtration rate at 48 hours).
Acute kidney injury, according to the VARC definition, occurred in 24 (14.6%) of 165 patients after TAVR. Acute kidney injury, according to RIFLE criteria, occurred in 19 patients (11.5%). Men (63% vs 38%, P = .03) and patients receiving blood transfusion (63% vs 39%, P = .04) were more likely to develop AKI. In multivariable analysis, only blood transfusion emerged as a predictor for AKI (odds ratio 3.74, 95% CI 1.36-10.3). Patients who developed AKI had higher in-hospital (21% vs 4%, P = .007) and 30-day mortality (29% vs 7%, P = .004) as compared with patients without AKI.
Acute kidney injury is a frequent complication of TAVR. Even a small increase (0.3 mg/dL) in baseline creatinine post-TAVR is associated with worse outcome. The poor prognosis of these patients should encourage improvement in patient selection and careful management for prevention of this complication.
American heart journal 06/2012; 163(6):1031-6. · 4.65 Impact Factor
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Cardiovascular revascularization medicine: including molecular interventions 05/2012; 13(3):184.
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ABSTRACT: Transcatheter aortic valve implantation is a novel therapeutic approach for high-risk patients with severe symptomatic aortic stenosis. The success rate of this new procedure is high; however, it is associated with issues such as vascular access site complications and embolization related to the advancement of a large bore delivery catheter through the femoral and iliac arteries and aortic arch. Using the Edwards SAPIEN transcatheter heart valve, we describe a case of transfemoral catheter aortic valve implantation complicated by a mobile mass attached to the valve, probable due to atherosclerotic plaque from the aorta. Shortly thereafter, the patient presented with ischemic colitis and subsequently died. © 2012 Wiley Periodicals, Inc.
Catheterization and Cardiovascular Interventions 04/2012; · 2.29 Impact Factor
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Steven Rosenberg,
Michael R Elashoff,
Hsiao D Lieu,
Bradley O Brown,
William E Kraus,
Robert S Schwartz,
Szilard Voros,
Stephen G Ellis, Ron Waksman,
John A McPherson,
Alexandra J Lansky,
Eric J Topol
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ABSTRACT: The majority of first-time angiography patients are without obstructive coronary artery disease (CAD). A blood gene expression score (GES) for obstructive CAD likelihood was validated in the PREDICT study, but its relation to major adverse cardiovascular events (MACE) and revascularization was not assessed. Patients (N = 1,160) were followed up for MACE and revascularization 1 year post-index angiography and GES, with 1,116 completing follow-up. The 30-day event rate was 23% and a further 2.2% at 12 months. The GES was associated with MACE/revascularizations (p < 0.001) and added to clinical risk scores. Patients with GES >15 trended towards increased >30 days MACE/revascularization likelihood (odds ratio = 2.59, 95% confidence interval = 0.89-9.14, p = 0.082). MACE incidence overall was 1.5% (17 of 1,116) and 3 of 17 patients had GES ≤ 15. For the total low GES group (N = 396), negative predictive value was 90% for MACE/revascularization and >99% for MACE alone, identifying a group of patients without obstructive CAD and highly unlikely to suffer MACE within 12 months.
Journal of Cardiovascular Translational Research 03/2012; 5(3):366-74. · 2.61 Impact Factor
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ABSTRACT: The penetration rate of devices in general, and in transcatheter aortic valve replacement (TAVR) specifically, is significantly delayed in the United States of America (USA) compared with in Europe. This is mostly due to the mission statement of the regulatory agencies in the USA, which requires very rigorous clinical testing of a device prior to its approval. The USA had a major role in the development and evaluation of this technology and USA research has enabled clinicians inside and outside of the USA to conduct a concise scientifically based assessment of the performance of TAVR devices in terms of safety and efficacy. In the following review, we provide data on the development of TAVR in the USA, revealing the critical role the USA has played in this extraordinary process.
Archives of cardiovascular diseases 03/2012; 105(3):160-4. · 0.66 Impact Factor
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ABSTRACT: Failed percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) is associated with adverse outcome. With recent improvements in PCI techniques, the incidence and predictors for failed primary PCI are unclear.
A clinical database of consecutive patients who underwent primary or rescue PCI from 1993 to 2011 was used to compare patients with successful versus failed PCI. Clinical follow-up was obtained in-hospital, at 30 days and at 1 year.
Of 2900 patients fulfilling our inclusion criteria, 111 (3.98%) had failed PCI. Patients who had failed PCI were older (65 vs. 61 years), were more likely to be women (46% vs. 32%), were more likely to have previous peripheral vascular disease (19% vs. 11%), previous PCI (29% vs. 20%), and were more likely to present with cardiogenic shock (25% vs. 11%) (all P < 0.05). Multivariable logistic regression analysis identified female gender (OR 1.54; 95% CI 1.01-2.38), cardiogenic shock (2.07; 1.22-3.49), previous PCI (1.71; 1.08-2.70), and type C lesion (2.47; 1.60-3.82) as independent predictors of PCI failure. The in-hospital (18% vs. 4%) and long-term mortality (48% vs. 14%) were worse in the failed PCI group compared to the successful group (P < 0.05).
In patients with STEMI, primary PCI failure is uncommon. It is associated with worse short- and long-term clinical outcome compared with a successful procedure. Special care should be taken when PCI is performed in women at higher risk for failure when presenting with STEMI.
Journal of Interventional Cardiology 02/2012; 25(2):111-7. · 1.18 Impact Factor
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Fabrizio D'Ascenzo,
Mario Bollati,
Fabrizio Clementi,
Davide Castagno,
Bo Lagerqvist,
Jose M de la Torre Hernandez,
Juriën M Ten Berg,
Bruce R Brodie,
Philip Urban,
Lisette Okkels Jensen, [......],
Robert J Applegate,
Piergiovanni Buonamici,
Ajay J Kirtane,
Anetta Undas,
Imad Sheiban,
Fiorenzo Gaita,
Giuseppe Sangiorgi,
Maria Grazia Modena,
Giacomo Frati,
Giuseppe Biondi-Zoccai
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ABSTRACT: BACKGROUND: Stent thrombosis remains among the most feared complications of percutaneous coronary intervention (PCI) with stenting. However, data on its incidence and predictors are sparse and conflicting. We thus aimed to perform a collaborative systematic review on incidence and predictors of stent thrombosis. METHODS: PubMed was systematically searched for eligible studies from the drug-eluting stent (DES) era (1/2002-12/2010). Studies were selected if including ≥2000 patients undergoing stenting or reporting on ≥25 thromboses. Study features, patient characteristics, and incidence of stent thrombosis were abstracted and pooled, when appropriate, with random-effect methods (point estimate [95% confidence intervals]), and consistency of predictors was formally appraised. RESULTS: A total of 30 studies were identified (221,066 patients, 4276 thromboses), with DES used in 87%. After a median of 22months, definite, probable, or possible stent thrombosis had occurred in 2.4% (2.0%; 2.9%), with acute in 0.4% (0.2%; 0.6%), subacute in 1.1% (1.0%; 1.3%), late in 0.5% (0.4%; 0.6%), and very late in 0.6% (0.4%; 0.8%). Similar figures were computed for studies reporting only on DES. From a total of 47 candidate variables, definite/probable stent thrombosis was more commonly and consistently predicted by early antiplatelet therapy discontinuation, extent of coronary disease, and stent number/length, with acute coronary syndrome at admission, diabetes, smoking status, and bifurcation/ostial disease also proving frequent predictors, but less consistently. CONCLUSIONS: Despite numerous possible risk factors, the most common and consistent predictors of stent thrombosis are early antiplatelet therapy discontinuation, extent of coronary disease, and stent number/length.
International journal of cardiology 02/2012; · 7.08 Impact Factor
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ABSTRACT: To compare access site complications with the Micropuncture 21 gauge (G) needle set to the standard 18G needle in patients undergoing percutaneous coronary intervention (PCI) using the femoral approach.
Vascular access site complications are the most common problems after PCI. The Micropuncture 21G needle set was recently introduced to minimize such complications.
A cohort of 3,243 consecutive patients was studied. Patients receiving thrombolytics, IIb/IIIa antagonist, coumadin, or intra-aortic balloon pump were excluded. Micropuncture access was used in 544 patients and standard 18G needle in 2,699. All access sites were managed with a vascular closure device. Primary endpoints included vascular perforation or limb ischemia requiring repair, retroperitoneal bleeding, pseudoaneurysm, arteriovenous fistula, and groin hematoma (>4 cm).
Patients undergoing PCI with Micropuncture were at higher risk: they were older (65.9 ± 9 vs. 64.7 ± 11.8, P = 0.03); had lower body surface area (1.9 ± 0.2 vs. 2.0 ± 0.3, P = 0.02); more prevalent peripheral vascular disease [119 (21.9%) vs. 380 (14.1%), P < 0.001] and renal failure [106 (19.6%) vs. 318 (11.8%), P < 0.001]. Overall, there was no significant difference in the access site complications rate using Micropuncture vs. standard needle, 7 (1.3%) vs. 27 (1.0%), respectively, P = 0.54. The Micropuncture group had significantly higher retroperitoneal bleeding, 0.7% vs. 0.18%, P = 0.04. After multivariable adjustment, only age remained significantly associated with vascular complications (OR 1.03, P = 0.04).
Femoral access using the Micropuncture technique did not reduce the incidence of vascular complications and the marginally higher than expected retroperitoneal bleeding is based on very small numbers. The routine use of the Micropuncture set and its technique should be revisited.
Catheterization and Cardiovascular Interventions 02/2012; 79(7):1180-5. · 2.29 Impact Factor
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ABSTRACT: A fractional flow reserve (FFR) of <0.8 is currently used to guide revascularization in lesions with intermediate coronary stenosis. Whether there is an intravascular ultrasound (IVUS) measurement or a cutoff value that can reliably determine which of these intermediate lesions requires intervention is unclear.
We assessed IVUS measurement accuracy in defining functional ischemia by FFR.
The analysis included 205 intermediate lesions (185 patients) located in vessel diameters >2.5 mm. Positive FFR was considered present at <0.8. IVUS measurements were correlated to the FFR findings in intermediate lesions with 40%-70% stenosis. Fifty-four (26.3%) lesions had FFR<0.8.
There was moderate correlation between FFR and IVUS measurements, including minimum lumen area (MLA) (r=0.36, P<.001), minimum lumen diameter (MLD) (r=0.25, P=<.001), lesion length (r=-0.43, P<.001), and area stenosis (r=-0.33, P=.01). A receiver operating characteristic curve (ROC) identified MLA<3.09 mm(2) (sensitivity 69.2%, specificity 79.5%) as the best threshold value for FFR<0.8. The correlation between FFR and IVUS was better for large vessels compared to small vessels. ROC analysis identified the best threshold value for FFR<0.8 of MLA<2.4 mm(2) [area under curve (AUC)=0.74] in lesions with reference vessel diameters of 2.5-3 mm, MLA<2.7 mm(2) (AUC=0.77) in lesions with reference vessel diameters of 3-3.5 mm, and MLA<3.6 mm(2) (AUC=0.70) in lesions with reference vessel diameters >3.5 mm.
Anatomic measurements of intermediate coronary lesions obtained by IVUS show a moderate correlation to FFR values. The correlation was better for larger-diameter vessels. Vessel size should always be taken into account when determining the MLA associated with functional ischemia.
Cardiovascular revascularization medicine: including molecular interventions 02/2012; 13(3):177-82.
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Ron Waksman,
Israel M Barbash,
Danny Dvir,
Rebecca Torguson,
Itsik Ben-Dor,
Gabriel Maluenda,
Zhenyi Xue,
Lowell F Satler,
William O Suddath,
Kenneth M Kent,
Augusto D Pichard
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ABSTRACT: Data from randomized clinical trials have shown the safety and efficacy of the XIENCE V in selected populations. However, limited data are available comparing the XIENCE V to the first-generation CYPHER sirolimus-eluting stent. This study aimed to assess the long-term safety and clinical efficacy of the XIENCE V everolimus-eluting stent compared to first-generation stents in an unselected patient population. This retrospective analysis included 6,069 patients treated with CYPHER, TAXUS, and XIENCE stents from 2003 to 2009 at our institution. The patients were followed up for ≥1 year after the index procedure. The baseline characteristics were generally comparable among the 3 groups, with the exception of a significantly greater prevalence of diabetes mellitus, systemic hypertension, and a history of angioplasty and coronary bypass surgery among the XIENCE patients. The XIENCE patients also had a twofold greater rate of type C lesions. One-year follow-up data were available for 82% of the patients. The 1-year major adverse cardiovascular events rate was 9.3% for the XIENCE stent versus 9.8% for the CYPHER stent and 11.5% for the TAXUS stent (p = 0.11). Mortality was lower in the XIENCE group than in the CYPHER and TAXUS groups (3.6% vs 4.9% vs 7.2%, respectively, p <0.001), and target lesion revascularization was similar (5.9% vs 5.2% vs 5.6%, respectively; p = 0.34). Stent thrombosis was lower in the XIENCE patients (0.2% vs 1.2% vs 0.7%, p = 0.007). In conclusion, in a contemporary United States clinical practice with an unselected patient population, use of the XIENCE V stent was associated with an improved safety profile and reduction of all-cause mortality and stent thrombosis compared to first-generation drug-eluting stents. The XIENCE V failed to demonstrate superiority for overall major adverse cardiovascular events, Q-wave myocardial infarction, and revascularization rates.
The American journal of cardiology 02/2012; 109(9):1288-94. · 3.58 Impact Factor
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Journal of Cardiovascular Magnetic Resonance 02/2012; 14 Suppl 1:P25. · 3.72 Impact Factor
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Gabriel Maluenda,
Itsik Ben-Dor,
Michael A Gaglia,
Kohei Wakabayashi,
Michael Mahmoudi,
Gabriel Sardi,
Ana Laynez-Carnicero,
Rebecca Torguson,
Zhenyi Xue,
Adrian D Margulies,
William O Suddath,
Kenneth M Kent,
Nelson L Bernardo,
Lowell F Satler,
Augusto D Pichard, Ron Waksman
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ABSTRACT: The optimal percutaneous treatment of drug-eluting stent (DES) in-stent restenosis (ISR) and the correlates for recurrent DES ISR remain unclear.
From 2003 to 2008, 563 patients presenting with recurrent symptoms of ischemia and angiographic ISR after DES implantation were included. Of these, 327 were treated with re-DES (58.1%), 132 underwent vascular brachytherapy (23.4%), and 104 were treated with conventional balloon angioplasty (18.5%). Variables associated with target lesion revascularization at 1 year were explored by individual proportional hazard models. This population presents a high prevalence of comorbidities, including diabetes (43.7%), previous myocardial infarction (MI) (45.8%), coronary bypass graft surgery (39.2%), chronic renal failure (18.8%), and heart failure (17.3%). Baseline clinical characteristics were balanced among the 3 groups; however, patients undergoing vascular brachytherapy presented with more complex lesions and a higher prevalence of prior stent/vascular brachytherapy failure than did the rest of the population. The overall incidence of recurrent DES failure at 1-year follow-up was 12.2%, which was similar among the 3 groups (P=0.41). The rate of the composite end point (death, Q-wave-MI and target lesion revascularization) at 1-year follow-up was 14.1% for re-DES, 17.5% for vascular brachytherapy, and 18.0% for conventional balloon angioplasty (P=0.57). After univariable analysis tested the traditional known covariates related to ISR, none of them were associated with repeat target lesion revascularization.
Recurrence of ISR after DES treatment failure is neither infrequent nor benign, and optimal therapy remains unclear and challenging. Given the absence of traditional risk factors for ISR in this population, further research is required to elucidate both the correlates involved in DES ISR and the optimal treatment for this condition.
Circulation Cardiovascular Interventions 02/2012; 5(1):12-9. · 6.06 Impact Factor
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Journal of Cardiovascular Magnetic Resonance 02/2012; 14 Suppl 1:P22. · 3.72 Impact Factor
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Circulation 01/2012; 125(3):550-5. · 14.74 Impact Factor
