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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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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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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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Itsik Ben-Dor,
Gabriel Maluenda,
Getachew D Iyasu,
Ana Laynez-Carnicero,
Camille Hauville,
Rebecca Torguson,
Petros Okubagzi,
Zhenyi Xue,
Steven A Goldstein,
Joseph Lindsay,
Lowell F Satler,
Augusto D Pichard,
Ron Waksman
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ABSTRACT: Left ventricular systolic dysfunction in patients with severe aortic stenosis (AS) is associated with poor outcome. This analysis was designed primarily to describe the clinical course of a large series of consecutive patients with severe AS and low ejection fraction (EF) (<40%) who, because of high surgical risk, were referred for transcatheter aortic valve implantation consideration. A cohort of 270 patients with severe AS and low EF (<40%) who were referred to participate in a clinical trial of transcatheter aortic valve implantation was studied. Clinical, hemodynamic, and periprocedural complications and follow-up mortality data were collected and compared between patients with low mean transvalvular gradients (≤40 mm Hg, n = 170 [63%]) and high transvalvular gradients (>40 mm Hg, n = 100 [37%]). Patients with low gradients were younger (mean age 79.8 ± 9.1 vs 83.8 ± 7.7 years, p <0.001) and had higher incidences of coronary artery disease and renal failure. Mean aortic valve area was larger (0.73 ± 0.23 vs 0.53 ± 0.18 cm(2), p <0.001), while mean EF (26.4 ± 6.9% vs 30.5% ± 6.6%, p <0.001), cardiac output (3.7 ± 1.1 vs 4.1 ± 1.3 L/min, p = 0.04), and cardiac index (1.9 ± 0.5 vs 2.1 ± 0.6 L/min/m(2), p = 0.04) were lower in patients with lower gradients compared to those with higher gradients, respectively. Mortality was higher in patients with low gradients (53.8%) at a mean follow-up of 151 days compared to those with high gradients (41%) at a mean follow-up of 256 days (p = 0.01). In conclusion, patients with severe AS and low EF with low transvalvular gradients are at higher risk for worse outcomes compared to patients with high transvalvular gradients. Surgery or transcatheter aortic valve implantation treatment and high baseline transvalvular gradient are associated with EF improvement.
The American journal of cardiology 01/2012; 109(7):1031-7. · 3.58 Impact Factor
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ABSTRACT: Transcatheter aortic valve implantation (TAVI) has been introduced as an alternative to conventional surgery for high-risk patients with aortic stenosis. A recently published randomized clinical trial demonstrated reduction of mortality in high-risk or inoperable patients when compared to medical treatment or balloon aortic valvuloplasty. Despite this evidence of superiority, the rate of TAVI complications is high, and perhaps the most devastating of the nonfatal complications is cerebral injury. This review will compare the incidence of stroke and "silent" cerebral injury after surgical aortic valve replacement and after TAVI and will discuss mechanisms that can lead to cerebral injury during these procedures and subsequently how to prevent this with new protection devices.
Cardiovascular revascularization medicine: including molecular interventions 01/2012; 13(2):133-40.
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ABSTRACT: Patients with severe aortic stenosis (AS) and prior cardiac surgery undergoing aortic valve replacement (AVR) are at high risk. Transapical AVR might reduce the risk in patients not suitable for the transfemoral approach. We aimed to describe the fluoroscopy and left anterior descending artery (LAD) angiography guidance technique for transapical AVR access and the initial related procedural results.
Patients with severe AS and prior cardiac surgery undergoing transapical AVR using LAD angiographic-guided apical puncture were analyzed (n=9). Additional guidance was added to the standard technique as follows. Minithoracotomy was performed at the level of the intercostal space in closer relationship to the apex identified by fluoroscopy. LAD angiography was performed at the time that the area of interest was recognized by radiopaque marker to ensure puncture lateral to the LAD. Apical needle puncture was performed under fluoroscopy guidance directed towards the aortic root.
The population had a mean age of 83 years and was more frequently male (89%) with a high-risk profile (mean Society of Thoracic Surgeons score of 11%). Two patients received the 23-mm Edwards SAPIEN valve, and seven patients received the 26-mm SAPIEN device. All nine patients underwent successful implantation of transcatheter aortic valves with virtual abolishment of transaortic gradient, without procedural complications.
Fluoroscopy and angiography for guidance of the transapical approach facilitate a safe and rapid access to the apex, insuring no risk of damage to the LAD or to large diagonals.
Cardiovascular revascularization medicine: including molecular interventions 12/2011; 13(2):106-10.
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Gabriel L Sardi,
Michael A Gaglia,
Gabriel Maluenda,
Rebecca Torguson,
Ana Laynez-Carnicero, Itsik Ben-Dor,
Camille Hauville,
Zhenyi Xue,
William O Suddath,
Kenneth M Kent,
Lowell F Satler,
Augusto D Pichard,
Joseph Lindsay,
Ron Waksman
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ABSTRACT: Ischemic cardiomyopathy with depressed left ventricular ejection fraction (LVEF) is predictive of death after percutaneous coronary intervention (PCI), but its association with stent thrombosis (ST) and the need for repeat revascularization is less clearly defined. In total 5,377 patients undergoing PCI were retrospectively evaluated. Multivariable Cox proportional hazards regression and competitive outcome analysis were employed. The primary end point was 1-year major adverse cardiac events (all-cause death, Q-wave myocardial infarction, ST, and target lesion revascularization [TLR]). Individual end points of ST and of TLR were also evaluated. Patients with normal LVEF (>50%) were compared to those with mild (41% to 50%), moderate (25% to 40%), and severe (<25%) decreases in LVEF. Patients with abnormal LVEF were older and more commonly diabetic and had renal insufficiency and heart failure syndrome (p <0.001 for all variables). These patients demonstrated more angiographically complex lesions and less frequently received a drug-eluting stent. The primary end point was significantly increased in patients with lower LVEF (9.7% for normal LVEF vs 20.6% for severely decreased LVEF, p <0.001). ST occurred more frequently in these patients (1.4% for normal LVEF vs 6% for severely decreased LVEF, p <0.001), but clinically driven TLR did not significantly change across LVEF categories. After adjustment, only moderate and severe LVEF decreases (i.e., LVEF ≤40%) demonstrated an association with major adverse cardiac events and with the individual outcome of ST. Subgroup analysis of patients receiving only a drug-eluting stent or a bare-metal stent demonstrated no statistically significant differences for the probability of ST. In conclusion, decreased LVEF is not associated with clinically driven TLR but does increase the risk of ST. Patients with LVEF ≤40% appear to be at significantly higher risk for ST and therefore might benefit from interventional and pharmacologic strategies aimed at minimizing this risk.
The American journal of cardiology 11/2011; 109(3):344-51. · 3.58 Impact Factor
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ABSTRACT: Background: Retroperitoneal hemorrhage (RPH) is a serious but infrequent complication of percutaneous coronary intervention (PCI). This study aimed to describe the clinical outcomes of patients who developed RPH following PCI in the current practice era, with particular focus on treatment strategies and the related prognostic value of abdominal/pelvic computed tomography (CT). Methods: Among 20,904 patients undergoing PCI, we identified 93 RPH (0.45%) confirmed by CT or by unequivocal surgical findings. We identified three groups with RPH for comparison: patients who developed refractory shock (systolic blood pressure <80 mm Hg for ≥30 min despite fluids and vasopressors, n = 16 [17.2%]); patients with transient hypotension (<30 min, n = 34 [36.6%]); and patients without hypotension (n = 43 [46.2%]). The primary endpoint was a composite of in-hospital mortality, myocardial infarction, and cerebral vascular accident (CVA). Results: Baseline clinical, angiographic, and procedural characteristics were similar among the three groups. Patients who developed refractory shock had significantly more bleeding quantified by abdominal/pelvic CT (P < 0.001), had a higher rate and amount of red blood cell transfusion (P < 0.001), and were managed invasively more frequently (68.7%) than the rest of the population. The primary endpoint trended higher in patients presenting with refractory shock; however, this difference was not statistically significant. The volume of bleeding quantified by CT and the timing of imaging diagnosis did not correlate with the primary endpoint. Red blood cell transfusion, but not clopidogrel discontinuation, was associated with the primary endpoint. Conclusions: RPH remains as a serious complication of PCI and is associated with high rates of mortality and morbidity independently of the therapeutic strategy. In patients who were hemodynamically stable, RPH volume as quantified by non-contrast abdominal/pelvic CT did not contribute to prognosis. © 2011 Wiley Periodicals, Inc.
Catheterization and Cardiovascular Interventions 11/2011; 80(1):29 - 36. · 2.29 Impact Factor
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Rafael Romaguera,
Kohei Wakabayashi,
Ana Laynez-Carnicero,
Gabriel Sardi,
Gabriel Maluenda, Itsik Ben-Dor,
Rebecca Torguson,
Kenneth M Kent,
Lowell F Satler,
William O Suddath,
Joseph Lindsay,
Augusto D Pichard,
Ron Waksman
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ABSTRACT: Vascular complications (VCs) occur in 3% to 8% of percutaneous coronary interventions (PCIs). However, only a portion of patients who experience VCs bleed significantly. The aim of this study was to assess the covariates associated with the amount of blood loss in patients experiencing postprocedural VCs as well as the effect of the degree of blood loss on long-term mortality. Overall, 7,718 unselected patients who underwent PCI through femoral access were evaluated. Those experiencing VCs were identified and stratified with regard to the degree of hematocrit (HCT) decrease after the procedure. In total, 444 patients (5.8%) had VCs. Compared to those without VCs, patients with VCs were older and had more extensive co-morbidities. Severe blood loss was most frequent in those who had vascular perforation requiring surgical repair or in those who had retroperitoneal bleeding. Overall, <25% of patients with hematoma had severe blood loss. The raw 1-year mortality was doubled in patients with minimal or moderate HCT decrease and was tripled in those with severe decreases in HCT. Similarly, the rate of definite stent thrombosis was tripled in patients with VCs and moderate or severe decreases in HCT. After adjustment, only patients with VCs and the greater HCT decreases had an increased risk for death at 1 year (hazard ratio 1.80, 95% confidence interval 1.03 to 3.14). Independent predictors of severe HCT decrease included age, female gender, glycoprotein IIb/IIIa inhibitor use, and activated clotting time peak. Bivalirudin and closure devices were independently associated with less frequent severe HCT decrease. In conclusion, VCs do not entail an increased risk for death at 1 year unless associated with severe blood loss. The use of bivalirudin and closure devices seems to reduce the risk for such complications.
The American journal of cardiology 09/2011; 109(1):75-81. · 3.58 Impact Factor
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Gabriel Maluenda, Itsik Ben-Dor,
Ana Laynez-Carnicero,
Israel M Barbash,
Gabriel Sardi,
Michael A Gaglia,
Lavinia Mitulescu,
Rebecca Torguson,
Steven A Goldstein,
Zuyue Wang,
William O Suddath,
Kenneth M Kent,
Lowell F Satler,
Augusto D Pichard,
Ron Waksman
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ABSTRACT: The coexistence of mitral regurgitation (MR) in patients with severe aortic stenosis (AS) is not infrequent and has been associated with adverse outcome. The aims of this study were to evaluate the change in MR severity and to identify the correlates of MR improvement in patients with severe AS and moderate to severe MR who underwent balloon aortic valvuloplasty (BAV). Patients with severe AS and at least moderate MR who underwent their first BAV procedures (n = 74) were divided into 2 groups: patients with improved- (n = 34 [46%]) and those without improved (n = 40 [54%]) MR after BAV on transthoracic echocardiography. The population had a mean age of 84 years and was more frequently female (63.5%), with a high risk profile (mean Society of Thoracic Surgeons score 15%, mean European System for Cardiac Operative Risk Evaluation score 57%). Baseline characteristics were balanced between the 2 groups. Patients with improved MR after BAV had smaller left atrial dimensions (45 ± 7 vs 49 ± 7 mm, p = 0.01) and lower peak aortic velocities (3.7 ± 0.6 vs 4.0 ± 0.8 m/s, p = 0.05) and mean transaortic valve gradients (33.2 ± 12.1 vs 40.6 ± 17.4 mm Hg, p = 0.05) at baseline. Left atrial dimension [odds ratio (OR) 3.37, p = 0.006], left ventricular end-diastolic dimension (OR 2.7, p = 0.04), and mean transaortic valve gradient (OR 1.04, p = 0.05), but not left ventricular systolic function or functional MR, were correlated with MR improvement by logistic regression analysis. In conclusion, nearly half of the patients with severe AS and coexistent MR showed improvement in the magnitude of MR after BAV. Larger left atrial and left ventricular end-diastolic dimensions and higher transaortic valve gradients were associated with lack of MR improvement.
The American journal of cardiology 09/2011; 108(12):1777-82. · 3.58 Impact Factor
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ABSTRACT: Disturbances in atrioventricular conduction are well-recognized complications of transcatheter aortic valve replacement. Percutaneous balloon aortic valvuloplasty (BAV) is a requisite step in transcatheter aortic valve replacement; however, the contribution of the BAV to atrioventricular conduction disturbances has not been elucidated. The present analysis was undertaken to ascertain the incidence and type of electrocardiographic changes associated with BAV and to consider the role of BAV in the conduction abnormalities after transcatheter aortic valve replacement. In 271 consecutive patients with symptomatic, severe aortic stenosis undergoing BAV, a standard 12-lead electrocardiogram was obtained before and serially after the procedure. Each was examined by experienced electrocardiographers. The cohort was divided into 2 groups with regard to the post-BAV appearance of conduction disturbances. The clinical and procedural characteristics of patients with these disturbances were compared to those in whom no conduction disturbance appeared. After BAV, 23 patients (8.5%) met the study definition of "new conduction defect": 4 patients (1.5%) required permanent pacemaker implantation for advanced atrioventricular block. New left bundle branch block appeared in 9 (3.3%) and left anterior hemiblock in 7 (2.6%). New right bundle branch block appeared in 2 and left posterior hemiblock in 1. No significant difference was found in the clinical or procedural characteristics. The ratio of the balloon size to the left ventricular outflow tract diameter was 1.21 ± 1.6 in those with new conduction defects and 1.15 ± 0.12 (p = 0.032) in those without. In conclusion, BAV is associated with a low incidence of cardiac conduction disturbances and a requirement for permanent ventricular pacing. The size of the valvuloplasty balloon should be carefully selected to avoid oversizing, which can lead to the development of postprocedure conduction disturbances.
The American journal of cardiology 08/2011; 108(9):1311-5. · 3.58 Impact Factor
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ABSTRACT: This study aimed to test whether advanced cardiovascular injection (ACI) via 4 French (Fr) catheters is more advantageous than manual injection with 6 Fr catheters.
For coronary angiography, proponents of contrast media ACI believe it utilizes smaller-diameter catheters when compared with manual injection, without compromising the quality of the angiogram, and has the potential to reduce the amount of contrast used and lessen the use of closure devices.
In a prospective study, 200 consecutive patients referred for elective coronary angiography were randomized to standard 6 Fr catheters with manual injection versus 4 Fr catheters with ACI. The study's primary endpoint is the quality of the coronary angiogram. Secondary endpoints include groin complications, utilization of closure devices, and volume of contrast media. Thirty-six patients who underwent ad hoc percutaneous coronary intervention were excluded from the analysis.
The final analysis included 80 patients treated with 4 Fr catheters with ACI and 84 patients treated with 6 Fr catheters with manual injection. The groups had similar demographic and clinical characteristics. The quality of the angiogram was similar between groups with the exception of more left coronary sinus flush with 4 Fr catheters (3.57 ± 1.1 vs. 2.98 ± 0.9, P < 0.001) and less closure device use with 4 Fr (25 vs. 71.4%, P < 0.01) compared to 6 Fr catheters. The procedure duration, volume of contrast used, vascular complications, and time to ambulation were similar between groups (all P > 0.05).
4 Fr diagnostic catheters with ACI offer similar quality coronary angiograms, similar rates of vascular complications, procedure duration, contrast used, and time to ambulation, but have a significantly lesser need for closure devices compared to the 6 Fr system with manual injection.
Catheterization and Cardiovascular Interventions 07/2011; 79(5):843-8. · 2.29 Impact Factor
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ABSTRACT: Objectives: This study aimed to test whether advanced cardiovascular injection (ACI) via 4 French (Fr) catheters is more advantageous than manual injection with 6 Fr catheters. Background: For coronary angiography, proponents of contrast media ACI believe it utilizes smaller-diameter catheters when compared with manual injection, without compromising the quality of the angiogram, and has the potential to reduce the amount of contrast used and lessen the use of closure devices. Methods: In a prospective study, 200 consecutive patients referred for elective coronary angiography were randomized to standard 6 Fr catheters with manual injection versus 4 Fr catheters with ACI. The study's primary endpoint is the quality of the coronary angiogram. Secondary endpoints include groin complications, utilization of closure devices, and volume of contrast media. Thirty-six patients who underwent ad hoc percutaneous coronary intervention were excluded from the analysis. Results: The final analysis included 80 patients treated with 4 Fr catheters with ACI and 84 patients treated with 6 Fr catheters with manual injection. The groups had similar demographic and clinical characteristics. The quality of the angiogram was similar between groups with the exception of more left coronary sinus flush with 4 Fr catheters (3.57 ± 1.1 vs. 2.98 ± 0.9, P < 0.001) and less closure device use with 4 Fr (25 vs. 71.4%, P < 0.01) compared to 6 Fr catheters. The procedure duration, volume of contrast used, vascular complications, and time to ambulation were similar between groups (all P > 0.05). Conclusions: 4 Fr diagnostic catheters with ACI offer similar quality coronary angiograms, similar rates of vascular complications, procedure duration, contrast used, and time to ambulation, but have a significantly lesser need for closure devices compared to the 6 Fr system with manual injection. © 2011 Wiley-Liss, Inc.
Catheterization and Cardiovascular Interventions 07/2011; 79(5):843 - 848. · 2.29 Impact Factor
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Rafael Romaguera,
Gabriel Sardi,
Ana Laynez-Carnicero, Itsik Ben-Dor,
Gabriel Maluenda,
Kohei Wakabayashi,
Camille Hauville,
Rebecca Torguson,
Zhenyi Xue,
Kenneth M Kent,
Lowell F Satler,
William O Suddath,
Augusto D Pichard,
Joseph Lindsay,
Ron Waksman
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ABSTRACT: Coronary perforation (CP) is a rare but catastrophic event that may be influenced by the procedural anticoagulation regimen. This study compared the consequences of CP in patients who underwent anticoagulation with bivalirudin (BIV; a nonreversible direct thrombin inhibitor with a shorter 1/2-life than heparin) to those in patients who underwent anticoagulation with heparin (HEP) at time of CP. Patients with CP were identified from 33,613 procedures available in our institutional angioplasty registry. The outcome of this group was compared based on anticoagulation regimen (BIV vs HEP). The primary end point for this analysis was the composite of in-hospital death, cardiac tamponade, or emergency cardiac surgery. Overall a cohort of 69 patients (0.2%) with CP was identified. BIV was the intraprocedural anticoagulant in 41 patients, whereas HEP was used in 28. Baseline characteristics were comparable between groups except for a higher frequency of systemic hypertension and hypercholesterolemia in the BIV group. Procedural characteristics were also similar including lesion complexity and perforation severity. Nearly 1/2 of CPs in each group was managed with prolonged balloon inflation alone. Protamine was used in 46% of HEP-treated patients. Covered stents tended to be used more frequently in the BIV group (p = 0.061). The primary composite end point was similar between groups (odds ratio 1.42, 95% confidence interval 0.47 to 4.29, p = 0.53). However, there was a lower rate of cardiac surgery requirement in BIV-treated patients (p = 0.037). In conclusion, our study suggests that choice of procedural anticoagulant agent does not influence outcome when CP occurs. Therefore, use of BIV should not be discouraged in patients undergoing high-risk intervention for perforations.
The American journal of cardiology 07/2011; 108(7):932-5. · 3.58 Impact Factor
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ABSTRACT: BACKGROUND: Coronary artery disease often coexists with severe aortic stenosis. The feasibility and safety of combined balloon aortic valvuloplasty (BAV) and percutaneous coronary intervention (PCI) are unknown. AIM: To compare outcomes and complications of combined BAV and PCI with BAV alone. METHODS: The study cohort consisted of 409 patients with severe aortic stenosis undergoing BAV from 1/2007 to 12/2010. Overall, 329 patients underwent BAV alone and 80 underwent concomitant PCI. Clinical and hemodynamic data, as well as acute and intermediate-term outcomes, were collected RESULTS: At the operator's discretion PCI was done before BAV in 66 (82.5%) and after in 14 (17.5%). Patients who underwent concomitant procedures had a higher incidence of prior stroke and a lower incidence of atrial fibrillation. Procedure time and fluoroscopic time were significantly greater in the BAV/PCI group, (90.0±36.6 vs. 72.8±39.8, p=0.002 and 20.5±10.9 vs. 12.9±7.0, p <0.001). Significantly more radiographic contrast was used in the BAV/PCI group (95.1±45.5 vs. 36.7±38.4 cc, p <0.001. Serious adverse events occurred with equal frequency 13.7% and 17.3%, p=0.44). Transfusion requirement was also similar (21.2% vs. 20.0%, p=0.81). The frequency of a periprocedural increase in troponin or creatinine was also similar. In the BAV alone group the mortality rate was 48.6% (n=160) during a mean follow-up of 191 days, and in the BAV/PCI group the mortality rate was 40% (n=32) during mean follow-up of 175.5 day, p=0.34. CONCLUSION: Combined BAV and PCI is safe and is associated with similar complications as BAV alone and may offer protection against myocardial ischemia during BAV. © 2011 Wiley-Liss, Inc.
Catheterization and Cardiovascular Interventions 07/2011; · 2.29 Impact Factor
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Itsik Ben-Dor,
Michael A Gaglia,
Israel M Barbash,
Gabriel Maluenda,
Camille Hauville,
Manuel A Gonzalez,
Gabriel Sardi,
Ana Laynez-Carnicero,
Rebecca Torguson,
Petros Okubagzi,
Zhenyi Xue,
Steven A Goldstein,
William O Suddath,
Kenneth M Kent,
Joseph Lindsay,
Lowell F Satler,
Augusto D Pichard,
Ron Waksman
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ABSTRACT: The primary inclusion criteria from both the Society of Thoracic Surgeons (STS) score and the logistic EuroSCORE are currently used to identify high-risk and inoperable patients eligible for transcatheter aortic valve implantation (TAVI). We aimed to examine the correlation between STS and logistic EuroSCOREs and their performance characteristics in patients referred for TAVI.
The study cohort consisted of 718 high-risk patients with severe aortic stenosis who were considered for participation in a TAVI clinical trial. The performance of the STS and logistic EuroSCOREs was evaluated in three groups: (a) medical management or balloon aortic valvuloplasty (BAV), 474 (66%); (b) 133 patients (18.5%) with surgical aortic valve replacement (AVR); (c) 111 (15.4%) with TAVI. The mean age was 81.8 ± 8.1 years, and 394 (54.8%) were female.
The mean STS score was 11.5 ± 6.1, and the mean logistic EuroSCORE was 39.7 ± 23.0. Pearson correlation coefficient showed moderate correlation between the STS and logistic EuroSCOREs (r = 0.61, P < .001). At a median follow-up of 190 days (range, 67-476), 282 patients (39.2%) died. The STS and logistic EuroSCOREs were both higher in patients who died as compared to those in survivors (13.1 ± 6.2 vs.10.0 ± 5.8 and 43.4 ± 23.1 vs. 37.5 ± 22, respectively; P < .001). The observed and predicted 30-day mortality rates in the medical/BAV group were 10.1% observed, 12.3% by STS and 43.1% by logistic EuroSCORE. In the surgical AVR group, the rates were 12.8% observed, 8.4% by STS and 25.6% by logistic EuroSCORE. In the TAVI group, the rates were 11.7% observed, 11.8% by STS and 41.2% by logistic EuroSCORE. The odds ratio (OR) for 30-day mortality in the medical/BAV group was 1.05 (P = .01) with STS and 1.003 (P = .7) with logistic EuroSCORE. In the surgical AVR group, the OR was 1.09 (P = .07) with STS and 1.007 (P = .6) with logistic EuroSCORE. In the TAVI group, the OR was 1.14 (P = .03) with STS and 1.03 (P = .04) with logistic EuroSCORE.
In high-risk patients with severe aortic stenosis, STS score is superior to the logistic EuroSCORE in predicting mortality. Clinical judgment should play a major role in the selection of patients with severe aortic stenosis for the different therapeutic options.
Cardiovascular revascularization medicine: including molecular interventions 07/2011; 12(6):345-9.
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ABSTRACT: To compare complication rates of a collagen-mediated closure device, suture-mediated closure technique and manual compression for access site management following balloon aortic valvuloplasty (BAV).
Vascular complications, including perforation, limb ischemia, ateriovenous fistulas, and pseudoaneurysm, are a common source of morbidity in patients undergoing BAV with large bore femoral artery access. The available options for closure of the access site include manual compression, suture-mediated closure devices, and recently reported collagen-based closure devices.
The study cohort consisted of 333 patients with severe aortic stenosis undergoing BAV. Patients were divided into four groups according to access closure method: (1) Manual compression in 64 (19.2%); (2) Proglide 6 Fr in 162 (48.6%); (3) Angio-Seal 8 Fr in 89 (26.75%); and (4) Prostar 10 Fr in 18 (5.4%).
There were no significant differences in baseline characteristics among the groups; although the Prostar group was had more males and the Angio-Seal group reported a lower incidence of renal failure and peripheral vascular disease. The Angio-Seal group had shorter procedural duration times compared with the other groups. In the Angio-Seal group (n = 47, 52.8%), a 10 Fr sheath size was primarily used to access the femoral artery, as compared with the manual compression and Proglide groups, which used a 12 Fr sheath in 29 (45.3%) and 66 patients (40.7%), respectively. A 13 Fr sheath was used in the Prostar group (n = 11, 61.1%), P < 0.001. The device failure rate was significantly higher in the Proglide group (n = 20, 12.3%) as compared with Angio-Seal (n = 3, 3.3%) and Prostar groups (n = 1, 5.5%), P = 0.03. Serious vascular complications requiring intervention were significantly higher in the manual compression group (n = 11, 17.1%) compared with the Proglide (n = 11, 6.7%), Angio-Seal (n = 5, 5.6%), and Prostar groups (n = 5, 1%), P < 0.001. The requirement for blood transfusion in the Angio-Seal group was significantly lower (n = 7, 7.8%) as compared with the manual compression (n = 20, 31.2%), Proglide (n = 35, 21.6%), and Prostar groups (n = 5, 27.7%), P < 0.001.
In our case series, collagen-based closure devices and suture-mediated closure devices had fewer vascular complications than manual compression for hemostasis following BAV. Patient selection for collagen-based versus suture-mediated closure requires further study.
Catheterization and Cardiovascular Interventions 07/2011; 78(1):119-24. · 2.29 Impact Factor
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Kohei Wakabayashi,
Gary Mintz,
Cedric Delhaye,
Yu Jeong Choi,
Joon Hyung Doh, Itsik Ben-Dor,
Michele Gaglia,
Rajbabu Pakala,
William Suddath,
Lowell Satler,
Kenneth Kent,
Augusto Pichard,
Neil Weissman,
Ron Waksman
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ABSTRACT: The process of in-stent neointimal hyperplasia (NIH) between drug-eluting stents (DES) and bare metal stents (BMS) might be different. We compared in vivo composition of in-stent NIH between DES and BMS using virtual histology-intravascular ultrasound (VH-IVUS).
Volumetric VH-IVUS was used to compare in-stent NIH between 23 DES and 15 BMS in 30 patients who underwent coronary angiography because of angina. The inner and outer VH-IVUS contours were drawn in a way to avoid the stent strut artifacts. Cross-sectional analysis was done at every VH-IVUS frame within the stent, thereby allowing volumetric measurement of stent, lumen, and NIH and its components. Baseline characteristics and IVUS measurements were similar between DES and BMS groups. The duration of follow-up was similar between DES (median 38 months [interquartile range, 7-59]) vs. BMS (median 40 months [interquartile range, 7-99]), (p=0.26). % necrotic core (NC) volume was significantly higher in DES than BMS: 19.5 [16.3, 25.6] vs. 12.1 [8.2, 18.5] (p=0.006). %NC volume significantly increased with time in BMS (p=0.007), but not in DES (p=0.24) so that at any given time point, %NC in DES was greater than in BMS. After adjustment for baseline differences, only DES (p=0.003) and stent age (p=0.043) were independent predictors of %NC volume. VH-IVUS in-stent thin-cap fibroatheromas were detected only in the DES group: 34.8% vs. 0%, p=0.013.
In vivo composition of in-stent NIH between DES and BMS was different, suggesting that the process of in-stent NIH in DES and BMS is diverse.
The Journal of invasive cardiology 07/2011; 23(7):262-8. · 1.84 Impact Factor
