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Safety and feasibility of using the Impella 2.5 device in patients with severe peripheral arterial disease: a single-center experience
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Abstracts / Cardiovascular Revascularization Medicine 12 (2011) e1–e46
transfer from the reservoirs has a comparable efficacy as that of non-laserstructured polyisoprene-wrapped balloons. Hence, WOMBAT® IIb allows a safe and efficient drug transfer with minimal surface coating. WOMBAT® is a trademark of AVIDAL Vascular GmbH, Germany, describing a new class of interventional products for intraluminal drug application: Wraps over Medical BAlloons Technology. doi:10.1016/j.carrev.2011.04.349
Safety and feasibility of using the Impella 2.5 device in patients with severe peripheral arterial disease: a single-center experience Jorge A. Castellanos, Rajesh Mallela, Salman A. Arain Tulane University Heart and Vascular Institute, Tulane University School of Medicine, New Orleans, LA, USA Background: The Impella 2.5 is a percutaneously inserted ventricular assist device used during high-risk angioplasty and in cardiogenic shock. It is relatively contraindicated in patients with peripheral arterial disease (PAD) because of its large sheath size. We evaluated the safety of using the device in patients with severe PAD. Methods: We included all patients (N=17) who received an Impella 2.5 device at our institution between April 2009 and June 2010. We compared baseline characteristics, major adverse cardiac events, procedural success and complication rates between patients with and without severe PAD (defined as presence of trans-atlantic society consensus type C or D lesions in the aortoiliac or femoral arteries). Results: Nine patients (55%) had severe PAD at baseline (Table 1). There was no difference in age, ejection fraction, prevalence of left main or multivessel disease between the PAD and non-PAD groups. The rates of ischemic cardiomyopathy (P=.02) and vascular complications (P=.04) were higher in the PAD group. There were no cardiac deaths in either group. Four patients underwent peripheral revascularization prior to Impella placement. There were three postprocedural vascular complications in the PAD group; however, none of the patients required vascular surgery.
Table 1 General characteristics of patients treated with an Impella 2.5 Impella (n=17)
PAD (n=9) No PAD (n=8) P value
Age, years (S.D.) EF, % (S.D.) ICM, n (%) LM disease, n (%) Multivessel disease, n (%) Shock, n (%) Cardiac/noncardiac death, n (%) MI or repeat revascularization, n (%)
62.7 (10.2) 20.6 (7.3) 9 (100) 4 (44) 8 (89) 0 0/0 (0) 0
54 (17) 20 (7.1) 5 (63) 3 (38) 5 (63) 4 (50) 0/2 (25%) 0
.11 .44 .02 .39 .11 .01 .06 -
Conclusion: The Impella 2.5 device can be safely used in patients with severe PAD. The risk of access site complications is higher in the setting of PAD, but this does not affect procedural success or mortality rates. doi:10.1016/j.carrev.2011.04.350
Robotically assisted PCI with CorPath 200 system: early evidence of potential benefits for patient and physician Michail M. Pankratov Corindus Inc, Natick, MA, USA Background: Robotic PCI has a potential to decrease radiation exposure and contrast fluid usage and increase technical precision. The CorPath 200 System (Corindus, Natick, MA, USA) is a vascular robotic system that drives
guidewires and stent/balloon catheters during PCI. It is comprised of the bedside unit and the interventional cockpit. The bedside unit consists of an articulated arm, robotic drive and a cassette. The radiation-shielded interventional cockpit houses a control console and video monitors with duplicate images of the catheterization lab monitors. The PCI devices are controlled by a physician via guidewire and catheter joysticks and/or touchscreen from a control console. Methods: Two studies — one animal and one clinical — were conducted recently where investigators looked at radiation exposure, contrast volume, procedure and X-ray times. The animal study assessed safety and technical efficacy of the three-vessel robotic PCI and compared it to the manual delivery in acute and chronic swine. The clinical study was designed to assess safety and technical efficacy of the robotic PCI in patients with simple de novo lesions. Results: Animal study. Devices were successfully deployed, and animals survived to their respective study endpoints. Angiographic results of robotically deployed devices were not different from manual deployment. Histopathology observed no differences between the two procedures. Procedural characteristics: procedure and X-ray time and radiation exposure to the animal were similar betweenroboticallyandmanuallytreatedanimals.Contrastvolumeandradiation exposure for the operator were ∼30% lower in the robotically-treated animals. Clinical study. All procedures were completed using the robotic system without complications, with a total procedure time of 43.0±18.6 min and fluoroscopy time of 11.5±3.7 min. These results compare favorably with the published results. There were no instances of in-hospital or 30-day follow-up MACE. Contrast utilization was below the average per procedure: 159 vs. 250 ml. Operator radiation exposure was 97% below that at the procedure table (1.8±1.9 vs. 61.6±55 μGy). Conclusion: Robotically-assisted PCI was comparable to the manual procedure in many categories: procedure time, X-ray time and cumulative radiation exposure to the animal. There were significantly less radiation exposure to the operator and lower contrast volume in robotically-assisted PCI as compared to the manual procedure. doi:10.1016/j.carrev.2011.04.351
New stent design to treat lesions on bifurcation and coronary ostium Raúl Valdesuso II, Juan R. Gimeno, Francisco J. Lacunza, Angel López, Juan Carlos Bonaque, José Nieto, Juan Garcia de Lara, José Hurtado, Eduardo Pinar, Mariano Valdés Hospital Universitario Virgen de la Arrixaca, Murcia, Spain Background: Treatment of bifurcation lesions is still a challenge. Different techniques have been published on how to approach bifurcations. Appropriate stent positioning just at the side branch ostium is difficult with conventional stent design. The Szabo technique (ST) allows anchoring of stents for exact positioning at ostial and bifurcated stenosis. For ST, it is necessary to alter the structure of the stent, with the risk of puncturing the balloon and loss of the stent if attempts are made to recover it. Methods: Since 2007, we have been working with the Research and Development (R&D) department of Hexacath (Paris, France) on a stent with a dedicated strut to perform the ST. Titan 2 Bioactive Stent (BAS) platform was used; the two proximal rings of the Titan 2 have been reinforced to prevent deformation of the stent due to the tension of the anchor guide. Dedicated cell has a pivoting design that allows the pull back of the stent inside the guiding catheter. The new stent has been called Titan V BAS. Results: In vitro tests performed at an independent laboratory have shown that Titan V design is not weaker than Titan 2. The addition of the specific strut and the proximal ring reinforcement is not associated with new or additional risks of stent/design fracture. Titan V has been subjected to the same rigorous fatigue test as Titan 2 in the Hexacath R&D laboratory, with identical results in both stents. Titan V has been implanted successfully in animal model and in ostial lesion. In the recovery tests, it has been possible to withdraw the stent into the guiding catheter without problem.
Abstracts / Cardiovascular Revascularization Medicine 12 (2011) e1–e46
transfer from the reservoirs has a comparable efficacy as that of non-laserstructured polyisoprene-wrapped balloons. Hence, WOMBAT® IIb allows a safe and efficient drug transfer with minimal surface coating. WOMBAT® is a trademark of AVIDAL Vascular GmbH, Germany, describing a new class of interventional products for intraluminal drug application: Wraps over Medical BAlloons Technology. doi:10.1016/j.carrev.2011.04.349
Safety and feasibility of using the Impella 2.5 device in patients with severe peripheral arterial disease: a single-center experience Jorge A. Castellanos, Rajesh Mallela, Salman A. Arain Tulane University Heart and Vascular Institute, Tulane University School of Medicine, New Orleans, LA, USA Background: The Impella 2.5 is a percutaneously inserted ventricular assist device used during high-risk angioplasty and in cardiogenic shock. It is relatively contraindicated in patients with peripheral arterial disease (PAD) because of its large sheath size. We evaluated the safety of using the device in patients with severe PAD. Methods: We included all patients (N=17) who received an Impella 2.5 device at our institution between April 2009 and June 2010. We compared baseline characteristics, major adverse cardiac events, procedural success and complication rates between patients with and without severe PAD (defined as presence of trans-atlantic society consensus type C or D lesions in the aortoiliac or femoral arteries). Results: Nine patients (55%) had severe PAD at baseline (Table 1). There was no difference in age, ejection fraction, prevalence of left main or multivessel disease between the PAD and non-PAD groups. The rates of ischemic cardiomyopathy (P=.02) and vascular complications (P=.04) were higher in the PAD group. There were no cardiac deaths in either group. Four patients underwent peripheral revascularization prior to Impella placement. There were three postprocedural vascular complications in the PAD group; however, none of the patients required vascular surgery.
Table 1 General characteristics of patients treated with an Impella 2.5 Impella (n=17)
PAD (n=9) No PAD (n=8) P value
Age, years (S.D.) EF, % (S.D.) ICM, n (%) LM disease, n (%) Multivessel disease, n (%) Shock, n (%) Cardiac/noncardiac death, n (%) MI or repeat revascularization, n (%)
62.7 (10.2) 20.6 (7.3) 9 (100) 4 (44) 8 (89) 0 0/0 (0) 0
54 (17) 20 (7.1) 5 (63) 3 (38) 5 (63) 4 (50) 0/2 (25%) 0
.11 .44 .02 .39 .11 .01 .06 -
Conclusion: The Impella 2.5 device can be safely used in patients with severe PAD. The risk of access site complications is higher in the setting of PAD, but this does not affect procedural success or mortality rates. doi:10.1016/j.carrev.2011.04.350
Robotically assisted PCI with CorPath 200 system: early evidence of potential benefits for patient and physician Michail M. Pankratov Corindus Inc, Natick, MA, USA Background: Robotic PCI has a potential to decrease radiation exposure and contrast fluid usage and increase technical precision. The CorPath 200 System (Corindus, Natick, MA, USA) is a vascular robotic system that drives
guidewires and stent/balloon catheters during PCI. It is comprised of the bedside unit and the interventional cockpit. The bedside unit consists of an articulated arm, robotic drive and a cassette. The radiation-shielded interventional cockpit houses a control console and video monitors with duplicate images of the catheterization lab monitors. The PCI devices are controlled by a physician via guidewire and catheter joysticks and/or touchscreen from a control console. Methods: Two studies — one animal and one clinical — were conducted recently where investigators looked at radiation exposure, contrast volume, procedure and X-ray times. The animal study assessed safety and technical efficacy of the three-vessel robotic PCI and compared it to the manual delivery in acute and chronic swine. The clinical study was designed to assess safety and technical efficacy of the robotic PCI in patients with simple de novo lesions. Results: Animal study. Devices were successfully deployed, and animals survived to their respective study endpoints. Angiographic results of robotically deployed devices were not different from manual deployment. Histopathology observed no differences between the two procedures. Procedural characteristics: procedure and X-ray time and radiation exposure to the animal were similar betweenroboticallyandmanuallytreatedanimals.Contrastvolumeandradiation exposure for the operator were ∼30% lower in the robotically-treated animals. Clinical study. All procedures were completed using the robotic system without complications, with a total procedure time of 43.0±18.6 min and fluoroscopy time of 11.5±3.7 min. These results compare favorably with the published results. There were no instances of in-hospital or 30-day follow-up MACE. Contrast utilization was below the average per procedure: 159 vs. 250 ml. Operator radiation exposure was 97% below that at the procedure table (1.8±1.9 vs. 61.6±55 μGy). Conclusion: Robotically-assisted PCI was comparable to the manual procedure in many categories: procedure time, X-ray time and cumulative radiation exposure to the animal. There were significantly less radiation exposure to the operator and lower contrast volume in robotically-assisted PCI as compared to the manual procedure. doi:10.1016/j.carrev.2011.04.351
New stent design to treat lesions on bifurcation and coronary ostium Raúl Valdesuso II, Juan R. Gimeno, Francisco J. Lacunza, Angel López, Juan Carlos Bonaque, José Nieto, Juan Garcia de Lara, José Hurtado, Eduardo Pinar, Mariano Valdés Hospital Universitario Virgen de la Arrixaca, Murcia, Spain Background: Treatment of bifurcation lesions is still a challenge. Different techniques have been published on how to approach bifurcations. Appropriate stent positioning just at the side branch ostium is difficult with conventional stent design. The Szabo technique (ST) allows anchoring of stents for exact positioning at ostial and bifurcated stenosis. For ST, it is necessary to alter the structure of the stent, with the risk of puncturing the balloon and loss of the stent if attempts are made to recover it. Methods: Since 2007, we have been working with the Research and Development (R&D) department of Hexacath (Paris, France) on a stent with a dedicated strut to perform the ST. Titan 2 Bioactive Stent (BAS) platform was used; the two proximal rings of the Titan 2 have been reinforced to prevent deformation of the stent due to the tension of the anchor guide. Dedicated cell has a pivoting design that allows the pull back of the stent inside the guiding catheter. The new stent has been called Titan V BAS. Results: In vitro tests performed at an independent laboratory have shown that Titan V design is not weaker than Titan 2. The addition of the specific strut and the proximal ring reinforcement is not associated with new or additional risks of stent/design fracture. Titan V has been subjected to the same rigorous fatigue test as Titan 2 in the Hexacath R&D laboratory, with identical results in both stents. Titan V has been implanted successfully in animal model and in ostial lesion. In the recovery tests, it has been possible to withdraw the stent into the guiding catheter without problem.