Improved outcome with novel device for low-pressure PTCA in de novo and in-stent lesions

Ischinger, Thomas; Solar, Ronald J.; Hitzke, Evelyn

doi:10.1016/s1522-1865(03)00118-5

Cited by 12 publications

(3 citation statements)

References 18 publications

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“…Therefore, adjuvant or alternative techniques that could facilitate an adequate anchorage of the balloon at the target lesion have been proposed. These range from simple balloon and guidewire techniques such as the hugging balloon and the buddy wire technique to dedicated ad hoc technologies, such as special balloons that incorporate externalized guidewires or the cutting balloon [7–9, 26]. All of them could prevent balloon slippage by introducing high longitudinal stresses at the target lesion.…”

Section: Discussionmentioning

confidence: 99%

Implications of the “watermelon seeding” phenomenon during coronary interventions for in-stent restenosis

Alfonso

Pérez-Vizcayno

Gómez-Recio

et al. 2005

Cathet. Cardiovasc. Intervent.

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The occurrence of balloon slippage ("watermelon seeding"; WMS) during treatment of patients with in-stent restenosis (ISR) has been described, but predisposing factors and the potential implications of this phenomenon remain unknown. In the Restenosis Intrastent: Balloon Angioplasty vs. Elective Stenting (RIBS) randomized study, 450 patients with ISR were included. Of these, 42 patients (9%) presented WMS during the procedure. WMS was detected in 26 patients (12%) in the balloon arm and 16 (7%) in the stent arm (P=0.11). In the stent arm, WMS was only noticed during balloon predilation, never during stent implantation. As compared with 408 patients without WMS, patients with WMS had more severe (TIMI flow 1; 21% vs. 8%; P=0.01) and diffuse (length>15 mm: 45% vs. 28%; P=0.02) ISR lesions. Patients with WMS required more balloon inflations, longer total inflation time, had more frequent crossover to stenting or ended the procedure with residual dissections, and eventually obtained poorer acute results (minimal lumen diameter, 2.35+/-0.5 vs. 2.53+/-0.5 mm; P=0.03). In addition, at 6-month follow-up, patients with WMS had a smaller minimal lumen diameter (1.26+/-0.7 vs. 1.61+/-0.7 mm; P=0.007) and a higher restenosis rate (56% vs. 37%; P=0.017). On logistic regression analysis, the WMS phenomenon emerged as an independent predictor of recurrent restenosis (adjusted RR=2.1; 95% CI=1.1-4.1; P=0.04). The WMS phenomenon may complicate treatment of patients with ISR. Long and severe lesions appear to predispose to this technical problem that never occurs during stent deployment. In patients with ISR, WMS is associated with cumbersome procedures and poorer acute and long-term angiographic results.

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Section: Discussionmentioning

confidence: 99%

Implications of the “watermelon seeding” phenomenon during coronary interventions for in-stent restenosis

Alfonso

Pérez-Vizcayno

Gómez-Recio

et al. 2005

Cathet. Cardiovasc. Intervent.

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“…In this study, a slow stepwise inflation protocol was used. A subset analysis in the study indicated that, when stents are to be used, optimal predilatation of the lesion with the FX MiniRAIL™ may allow full‐stent expansion at nominal deployment pressures 13,14 …”

mentioning

confidence: 99%

FX MiniRAIL™ Catheter Usage for Treatment of De Novo Complex Coronary Lesions: Results from the “OFFAR”

Vitrella¹,

Sangiorgi²,

Kornowski

et al. 2006

J Interven Cardiology

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“…The use of high-pressure balloon inflation has been associated with an increased incidence of restenosis due to injury caused by balloon inflation (Oesterle, et al 1998). Therefore, novel low-pressure dilation balloon catheters, such as the FX miniRAIL manufactured by X Technologies, are being explored as a method to reduce the balloon pressure required for stent expansion in complex coronary lesions (Ischinger, Solar and Hitzke 2003).…”

Section: Delivery Systemsmentioning

confidence: 99%

Design and Optimization of a Blood Vessel Mimic Bioreactor System for the Evaluation of Intravascular Devices in Simple and Complex Vessel Geometries

Leifer¹

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Coronary artery disease affects millions of people and the ability to detect and treat the disease is advancing at a rapid rate. As a result, the development of intravascular technologies is the focus of many medical device manufacturers. Specifically, coronary stent implantation is being performed in an increasing number of patients and a number of new stent designs have been introduced to the market, resulting in the need for improved preclinical testing methods. An in vitro tissue engineered "blood vessel mimic" (BVM) system has previously been established and its feasibility for the initial testing of newly emerging intravascular technology has been demonstrated. There are limitations that exist with this original design, however, and the focus of this thesis was to both improve and expand upon the original model. Therefore, research was conducted based on two specific aims. The first aim was to develop a more ideal BVM system to accommodate a wider range of stent lengths and diameters, while allowing for easy graft insertion and seal-ability. The second aim was to develop next generation BVM systems, v focused on future needs and technology, such as long, angulated and bifurcated geometries.The work described in this thesis demonstrates that a BVM chamber can be created which has the advantages of easy graft insertion and seal-ability, as well as the ability to accommodate varying sizes of vessel scaffolds, all while maintaining the needs of a tissue engineering bioreactor system. The next generation BVM systems presented demonstrate that the BVM concept can be expanded to meet the needs of long, angulated and bifurcated geometries. Overall, the work in this thesis describes the design and optimization of an in vitro blood vessel mimic bioreactor system for the evaluation of intravascular devices, specifically coronary stents, in simple and complex vessel geometries.vi ACKNOWLEDGEMENTS First, I would like to acknowledge and thank the members of my thesis committee: Dr. Kristen O'Halloran Cardinal, Dr. Trevor Cardinal and Dr. Lily Laiho. Thanks for all your guidance and input and for providing assistance and ideas throughout the project.

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Improved outcome with novel device for low-pressure PTCA in de novo and in-stent lesions

Cited by 12 publications

References 18 publications

Implications of the “watermelon seeding” phenomenon during coronary interventions for in-stent restenosis

Implications of the “watermelon seeding” phenomenon during coronary interventions for in-stent restenosis

FX MiniRAIL™ Catheter Usage for Treatment of De Novo Complex Coronary Lesions: Results from the “OFFAR”

Design and Optimization of a Blood Vessel Mimic Bioreactor System for the Evaluation of Intravascular Devices in Simple and Complex Vessel Geometries

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