Successful Use of a Novel PCI Guiding Catheter with an Extra Lumen in an Animal Model
- Volume 21 - Issue 6 - June, 2009
- Posted on: 6/9/09
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ABSTRACT: This report describes a novel percutaneous coronary intervention (PCI) guiding catheter equipped with an additional lumen running along the full length of the main lumen. This lumen allows continuous infusion of medications (e.g., thrombolytic agents, nitroglycerin, glycoprotein IIb/IIIa inhibitors, etc.) during the procedure without interrupting the procedure being carried out using the main lumen. Intracoronary infusion of medication at the time of PCI should allow for more effective treatment with lower dosages and fewer side effects.
J INVASIVE CARDIOL 2009;21:300–302
Conventional percutaneous coronary intervention (PCI) guiding catheters allow guidewire, percutaneous transluminal coronary angioplasty (PTCA) balloon catheter and stent insertion to treat coronary stenosis. They also allow administration of medications given as intracoronary boluses. However, they do not allow concomitant administration of medication at a constant rate during the procedure itself. To achieve continuous infusion during PCI, medications are currently administered systemically through the venous system.
We describe a novel PCI guiding catheter equipped with an additional lumen running along the full length of the main lumen. This lumen allows continuous infusion of medications during the procedure without interrupting the procedure being carried out using the main lumen.
Double-lumen guiding catheter (DLGC). The novel PCI guiding catheter may be produced in any conventional configuration (e.g., Judkins, extra-backup, Amplatz, etc.). For the current proof of concept study, a prototype with an extra-backup configuration was produced. The length of this prototype was 103.5 cm, with an outer diameter of 0.086 inches (6.55 Fr). The catheter has a main lumen with an inner diameter of 0.068 inches (1.7272 mm) to be used for PCI, as well as an additional lumen, with an inner diameter of 0.0179 inches (0.4546 mm), running along the full length of the main lumen (Figures 1 and 2).
The prototype was produced for the authors by Creganna Medical Devices of Marlborough, Massachusetts.
In vitro testing. The prototype extra lumen was attached to a saline bag via a volumetric infusion pump (IVAC). Saline was delivered up to a rate of 300 ml/hr without interruption, even when injections of 10 ml of ioxaglate contrast were given via the main lumen, or when coronary stents (i.e., Medtronic Driver 3.5 x 24 mm; Boston Scientific Liberté 3.0 x 24 mm and Cordis Bx Velocity 3.0 x 18 mm) were delivered through the main lumen.
The saline exit at the distal part of the catheter was in the form of drops, not a stream.
Animal study. The study protocol was approved by the Hadassah-Hebrew University Medical Center’s Animal Care and Use Committee.
A 35 kg commercial female pig was sedated, intubated and anesthetized by a experienced veterinarian. A 7 Fr introducer was inserted into the right femoral artery. Heparin 5,000 Units intravenous (IV) was given at the beginning of the procedure. The DLGC main lumen was flushed with heparinized saline and the extra lumen was flushed with pure heparin. The DLGC was advanced over a conventional 0.16 inch J wire to the ascending aorta. The J wire was withdrawn and the catheter was gently manipulated to intubate the left main coronary ostium. The left coronary system was visualized with contrast injection. The extra lumen was then connected to a saline bag via an IVAC at an infusion rate of 100 ml/hr. In order to prove that the DLGC is an appropriate PCI guiding catheter, a PTCA guidewire was advanced to the left circumflex coronary artery. A conventional 3.5 x 24 mm Driver coronary stent (Medtronic, Inc., Minneapolis, Minnesota) was advanced over the wire to the coronary artery (Figure 3). During that time, the saline infusion through the extra lumen proceeded without interruption. Stent deployment was not part of the protocol, and therefore was not performed. The stent and the guidewire were withdrawn and the DLGC was removed. Femoral hemostasis was achieved by local pressure. The pig was allowed to wake up and the tracheal tube was successfully removed. The pig was kept for an additional 5 days at the animal facility, with no complications noted.
Discussion. This report demonstrates the successful use of a novel DLGC that allows for continuous intracoronary infusion of fluid without interrupting the PCI procedure being carried out using the main lumen.
This lumen allows continuous infusion of medications (e.g., thrombolytic agents, nitroglycerin, glycoprotein (GP) IIb/IIIa inhibitors, etc.) during the procedure without interrupting the procedure being carried out using the main lumen. Intracoronary infusion of medication at the time of PCI should allow for more effective treatment, with lower dosages and fewer side effects.
One potential benefit of the DLGC is prevention of the no-reflow phenomenon which occurs in 10–15% of primary PCIs. Primary PCI is currently the preferred reperfusion method for patients with ST-elevation myocardial infarction in centers that can provide prompt, high-quality procedures.1 The immediate goal of reperfusion is to achieve a thrombolysis in myocardial infarction (TIMI)-3 flow rate in the infarct-related artery as soon as possible.1 Primary PCI, however, only results in TIMI-3 flow in, at most, 85–90% of patients.2,3 The failure to achieve TIMI-3 flow (i.e., no-reflow phenomenon) results in very unfavorable short- and long-term prognoses.4–11 Current pharmacological management involves the use of vasodilators including nitrates, verapamil, papaverine, adenosine, nicardipine and sodium nitroprusside, as well as antiplatelet agents such as GP IIb/IIIa inhibitors.12,13 The DLGC enables continuous intracoronary infusion of these medications throughout performance of the PCI and may allow administration of lower doses, with fewer side effects, while achieving similar results.
Another emerging option for use in PCI is the administration of thrombolytic agents, particularly those with short half-lives such as microplasmin.14,15 The intracoronary administration of such an agent throughout PCI may lower the risk of no-reflow while avoiding side effects related to systemic thrombolysis.
In conclusion, the use of this novel DLGC in a swine model was safe and effective.
From the *Department of Medicine, Hadassah-Hebrew University Medical Center, Mt. Scopus, and the §Authority for Animal Facilities, Hebrew University, Jerusalem, Israel.
Supported by a grant (80606-03) to D.R. from Hadasit- the technology transfer company of Hadassah Hebrew-University hospitals.
Disclosure: David Rott is the inventor of the Novel PCI Guiding Catheter.
Manuscript submitted October 13, 2008, provisional acceptance given January 9, 2009, final version accepted February 5, 2009.
Address for correspondence: David Rott, MD, Department of Medicine, Coronary Care Unit, Hadassah-Hebrew University Medical Center, Mt. Scopus, P.O.B 24035, Jerusalem 91240, Israel. E-mail: [email protected]