In vitro results of a new minimally invasive aortic valve resecting tool☆☆☆

Wendt, Daniel; Müller, W.-U.; Hauck, Florian; Thielmann, Matthias; Wendt, H; Kipfmüller, Brigitte; Vögel, Bernd; Jakob, Heinz

doi:10.1016/j.ejcts.2009.01.005

Cited by 18 publications

(7 citation statements)

References 21 publications

(20 reference statements)

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“…The concept of pretreating the native valve has been discussed and proposed including valve debulking, modification and removal (9,(13)(14)(15). Substantial acute aortic insufficiency can occur during aortic valve pretreatment, and the hemodynamic protection of the TAV can allow for the development of valve pretreatment from concept to reality.…”

Section: Discussionmentioning

confidence: 99%

Percutaneous aortic valve replacement (part 3): Balloon counterpulsation of a novel temporary aortic valve

Ho¹

2011

Minimally Invasive Therapy & Allied Technologies

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A previously published two-part study described an engineering design of a percutaneous aortic valve (PAV) replacement system, which utilizes a novel temporary aortic valve (TAV) support to improve procedural outcomes and safety. Conceptually, this investigational approach can promote accurate PAV placement, procedural hemodynamic stability, smaller catheter delivery system, reduction in PAV regurgitation, reduction in conduction and vascular complications. The balloon TAV can potentially facilitate the PAV replacement procedure by serving as the patient's surrogate aortic valve while the native valve is pretreated and replaced. The original TAV is designed to function with an effective aortic stenosis and insufficiency in moderate ranges, which lessens from the patient's more critical valve condition, should be well tolerated when the native valve becomes nonfunctional during the replacement process. Further optimization of the TAV's hemodynamic profile could further improve the system's overall performance and enhance the realization of a truly minimally invasive, cath lab-based PAV replacement procedure comparable to that of percutaneous coronary intervention. This study explores design permutations from the original published TAV, including varying the number of balloons and adding balloon counterpulsations, to improve upon its hemodynamic profile to better serve as the patient's surrogate valve and the overall PAV replacement procedure.

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Section: Discussionmentioning

confidence: 99%

Percutaneous aortic valve replacement (part 3): Balloon counterpulsation of a novel temporary aortic valve

Ho¹

2011

Minimally Invasive Therapy & Allied Technologies

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“…Aortic valve resection was first introduced by our group in 2005 using a water-jet scalpel and a resection chamber using a Hol:YAG laser. 17 In 2009, Wendt et al 18 reported on a minimally invasive aortic valve resection tool equipped with rotating and foldable Nitinol (Nitinol Devices & Components, Inc., Fremont, CA USA) cutting edges. Other aortic valve resection devices were presented by Bombien et al 19 in 2010 using a valve isolation chamber and by Astarci et al 20 in 2011 using a circular blade.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Different Resection Tools for Human Calcified Aortic Valves

Marczynski-Bühlow

Gro

Berndt

et al. 2014

Innovations�(Phila)

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Objective Symptomatic severe aortic valve stenosis is a disease primarily found in patients of advanced age. The standard therapy is the aortic valve replacement. Transcatheter aortic valve implantation (TAVI) is a treatment for patients ineligible for conventional aortic valve replacement. To minimize the incidence of TAVI-related complications, such as paravalvular leakage, pacemaker necessity, and ostial coronary occlusion, our research group works on the development of resection tools for aortic valves. The aim of this study was to investigate ex vivo different resection tools for human calcified aortic valves concerning cross-section morphology. Methods With the use of 12 human calcified aortic leaflets, the effect of laser scalpel, punching device, and scissors on cross-section morphology was investigated. Scanning electron microscopy and histological analyses were applied to evaluate the cutting surface area. Results The cross-section areas created by a laser scalpel were smooth, regular, and uniform, whereas these areas were rough, irregular, and inhomogeneous when using the scissors or the punching device. Quantitative analysis of the cutting edges demonstrated significant differences between the three resection tools. The best results were obtained for the laser scalpel compared with the punching device ( P < 0.001) and for the laser scalpel compared with the scissors ( P < 0.05), whereas the scissors compared with the punching device showed no significant differences ( P > 0.05). Conclusions Laser cutting of human calcified aortic valves demonstrated the best results concerning homogeneous cross-section morphology compared with the punching device and the scissors and seems to be a promising tool for aortic valve resection during TAVI procedures in the future.

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“…The diameter of the device is still large, but this can be reduced in the next prototypes. The goal of this device is the controlled resection by grip and not by oscillating blades, 13 which will reduce the risk for any injury to the aortic root. Furthermore, the direct implantation option with the crimped valve, ''parked'' in the ascending aorta, offers an effective valve deployment.…”

Section: Discussionmentioning

confidence: 99%

Transcatheter Valve Replacement: New concepts for Microsurgery inside the Heart

Brecht¹,

Friedrich²,

Heinisch³

et al. 2013

Innovations�(Phila)

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Objective Transcatheter aortic valve implantation gained clinical relevance with an impressive and peerless power; however, the procedure induces unsolved complications such as paravalvular leakage, occlusion of coronary ostia, and vascular complications. The safe removal of bulky calcified valves will improve the outcome, well known through the open surgical procedure. In this article, a new stapler-based resection and implantation device as well as a new approach for valve isolation during normal heart cycle without extracorporeal circulation will be analyzed. Methods First, a novel stapler-based instrument for transapical aortic valve replacement [removal and implantation; stapler-based aortic valve replacement (StapAVR)] was constructed and analyzed in an aortic debris model. Artificial aortic valves (N = 20), containing fluorescent granules to simulate the calcification, were placed into an aortic model in anatomical supine position (DP) and right-sided lateral position (RP). With the StapAVR, resection before implantation was performed in a water-filled basin. Black light was used for debris visualization. The procedures have been digitally recorded and analyzed due to procedural times, and the debris amount in thoracic side branches. Second, an enhanced prototype of the pulmonary valve isolation chamber (PVIC) was analyzed in porcine in vitro (n = 10) and in vivo models (n = 1). This PVIC contains a microaxial pump (Impella; Abiomed, Aachen, Germany) in the central bypass channel. It was deployed through the right ventricular wall. Once the PVIC was in place, the pump was started before isolating the valve. The complete hemodynamic monitoring was digitally recorded. Results The deployment of the StapAVR in the correct position and the valve resection time took a mean (SD) of 95.8 (19) seconds in DP and 90.1 (18) seconds in RP. Fluorescent debris was found: in the left coronary artery, 22% in DP and 7% in RP; in the ascending aorta, 0% in DP and 11% in RP; in the aortic bulbous, 5% in DP and 10% in RP; in the left ventricle, 8% in DP and 14% in RP; in the brachiocephalic trunk, 4% in DP and 9% in RP; and in the descending aorta, 46% in DP and 1% in RP. Consecutive valved stent implantation was performed without complications. The PVIC deployment time in vivo was 5 minutes, replacements included. The total valve isolation time was 21 minutes, with a mean (SD) bypass flow of 2.1 (0.4) L/min. The oxygen saturation showed a median of 91% (range, 83%–97%), and the median arterial blood pressure was 69 mm Hg (systolic; range, 47–120 mm Hg) and 40mm Hg (diastolic; range, 32–56 mm Hg) without the use of inotropes or vasopressors. Electrocardiogram confirmed sinus rhythm during isolation. Conclusions The resection of the artificial valves followed by valved stent implantation was possible with the StapAVR. In vivo, the procedure will be carried out under rapid pacing and sudden vacuum; however, the results of this in vitro debris model underline the need for isolation or filter devices during transcatheter aortic valve implantation to avoid embolization. Secondly, the use of the pump-advanced PVIC showed stable heart function for 21 minutes under isolated pulmonary valve conditions. This time will be adequate to remove bulky calcifications and to implant a valved stent. Improvements of both prototypes are ongoing. Nevertheless, the presented concepts showed promising application possibilities in the future.

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In vitro results of a new minimally invasive aortic valve resecting tool☆☆☆

Cited by 18 publications

References 21 publications

Percutaneous aortic valve replacement (part 3): Balloon counterpulsation of a novel temporary aortic valve

Percutaneous aortic valve replacement (part 3): Balloon counterpulsation of a novel temporary aortic valve

Comparison of Different Resection Tools for Human Calcified Aortic Valves

Transcatheter Valve Replacement: New concepts for Microsurgery inside the Heart

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