Abstract
Objectives
The aim of this study was to evaluate the feasibility and safety of the 6-Fr Glidesheath Slender, which has equivalent outer size to the conventional 5-Fr sheath, for use with the 6-Fr intra-aortic balloon pump (IABP) catheter.
Methods
Between May 2014 and March 2015, 24 patients with acute coronary syndrome underwent percutaneous coronary intervention using a 6-Fr IABP catheter through a 6-Fr Glidesheath Slender for support. The adverse events, including access site complications, kinking of the sheath during the procedure, and any evidence of balloon pump failure, were retrospectively investigated.
Results
Insertion of the IABP catheter through either the femoral or brachial artery was successful in all patients. The mean support time was 32.4 ± 22.0 h. No major hemorrhagic event or severe limb ischemia was observed. Kinking of the shaft occurred during insertion in one patient; however, the subsequent balloon pumping was well maintained and did not require exchange of the sheath or IABP catheter. No kind of IABP failure was observed.
Conclusion
Although this sheath was originally designed to allow radial access, our results suggest that the use of the Glidesheath Slender is feasible for insertion of the 6-Fr IABP catheter through the brachial and femoral arteries, and may reduce vascular complications in patients who undergo percutaneous coronary intervention.
1
Introduction
In recent years, major technical advances in intra-aortic balloon pumping (IABP) catheters have been made, including the introduction of low-profile catheters and the use of percutaneous insertion through a sheath introducer . To date, many clinical studies have confirmed the impact of lower profile IABP catheters on the incidence of vascular complications . Recently, the 6-Fr IABP catheter was introduced for clinical use in Japan, and its feasibility and efficacy have already been reported; it is expected to further reduce the incidence of access site complications .
For the insertion of 6-Fr IABP catheters, usually the dedicated 6-Fr sheath introducer is used; however, with the recent development of sheath introducers, the use of a 6-Fr sheath introducer that has a thinner wall structure and the same outer diameter compared to the conventional 5-Fr introducer has been established for percutaneous coronary intervention (PCI) . This introducer is currently distributed for trans-radial access only, as it may kink in the absence of a guiding catheter or inner sheath if used for the brachial or femoral approach, owing to its very thin size. However, we hypothesize that this introducer can be safely used for the 6-Fr IABP catheter, as the caliber of the puncture site becomes virtually 5-Fr, and that this may contribute to further reduction of access site complications, thus allowing early ambulation of patients undergoing coronary intervention.
Accordingly, in this study, we evaluated the feasibility of hemodynamic support with 6-Fr IABP catheters during PCI, using this sheath introducer with thin wall structure. To the best of our knowledge, this is the first feasibility study for application of the Glidesheath Slender with the 6-Fr IABP catheter.
2
Methods
2.1
Patient population
Between May 2014 and March 2015, we used the 6-Fr Glidesheath Slender for insertion of 6-Fr IABP catheters for 24 patients who underwent primary PCI. The use of the 6-Fr IABP catheter was determined at the operators’ discretion, although it was mainly based on the patients’ body size. This study was approved by the Institutional Review Board of the Sakurakai Takahashi Hospital, and informed written consent was obtained from each patient.
2.2
IABP catheters
The technical features of the 6-Fr intra-aortic balloon pump catheter (Zeon Medical Corp., Tokyo, Japan) used in this study have been previously described in detail . The balloon volume was 30 mL, and the length of the catheter shaft was 52.4 cm, which is the longest shaft among the currently available catheters smaller than 7.5-Fr ( Fig. 1 ). For balloon pumping, the Datascope CS 100 (Datascope Corp., Fairfield, NJ) or system 97 (Datascope Corp.) was used.
2.3
Sheath introducer
The Glidesheath Slender (Terumo, Tokyo, Japan) has been developed as a 6-Fr compatible radial sheath with hydrophilic coating and a thinner wall than the conventional 6-Fr sheaths, and thereby achieves less invasiveness during the trans-radial approach. The thickness of the wall was reduced to 0.12 mm, while keeping the inner diameter of 2.22 mm. As a result, the outer diameter was reduced from 2.63 to 2.45 mm. This thinner wall structure is considered prone to kinking, especially when the inner sheath is retrieved after insertion into the vessel and when the guiding catheters are exchanged; due to this feature, the introducer is considered unsuitable for the brachial or femoral approach.
2.4
Hemostasis after retrieval of the IABP catheter
To achieve hemostasis after retrieval of the IABP catheter, manual compression was applied for approximately 15 min when the procedure was conducted via the femoral approach. Additional manual compression was applied when required. The Tometa-kun (Zeon Medical Corp.), a hemostatic device that enables pneumatic compression, was used when the procedure was conducted via the brachial approach.
2.5
Evaluation criteria
The evaluation parameters used included the incidence of insertion difficulty; access site complications, including hemorrhage, limb ischemia, vascular damage necessitating surgical repair, and death, including that directly related to IABP insertion; and IABP failure, including helium leakage and insufficient inflation. Severe access site hemorrhage was defined as bleeding at the balloon insertion site leading to hemodynamic compromise requiring transfusion or surgical intervention. Severe limb ischemia was defined as loss of pulse or sensation or abnormal limb temperature or pallor requiring surgical intervention. IABP failure included balloon rupture and poor helium inflation, that is, incomplete expansion of the balloon or insufficient augmentation.
2
Methods
2.1
Patient population
Between May 2014 and March 2015, we used the 6-Fr Glidesheath Slender for insertion of 6-Fr IABP catheters for 24 patients who underwent primary PCI. The use of the 6-Fr IABP catheter was determined at the operators’ discretion, although it was mainly based on the patients’ body size. This study was approved by the Institutional Review Board of the Sakurakai Takahashi Hospital, and informed written consent was obtained from each patient.
2.2
IABP catheters
The technical features of the 6-Fr intra-aortic balloon pump catheter (Zeon Medical Corp., Tokyo, Japan) used in this study have been previously described in detail . The balloon volume was 30 mL, and the length of the catheter shaft was 52.4 cm, which is the longest shaft among the currently available catheters smaller than 7.5-Fr ( Fig. 1 ). For balloon pumping, the Datascope CS 100 (Datascope Corp., Fairfield, NJ) or system 97 (Datascope Corp.) was used.
2.3
Sheath introducer
The Glidesheath Slender (Terumo, Tokyo, Japan) has been developed as a 6-Fr compatible radial sheath with hydrophilic coating and a thinner wall than the conventional 6-Fr sheaths, and thereby achieves less invasiveness during the trans-radial approach. The thickness of the wall was reduced to 0.12 mm, while keeping the inner diameter of 2.22 mm. As a result, the outer diameter was reduced from 2.63 to 2.45 mm. This thinner wall structure is considered prone to kinking, especially when the inner sheath is retrieved after insertion into the vessel and when the guiding catheters are exchanged; due to this feature, the introducer is considered unsuitable for the brachial or femoral approach.
2.4
Hemostasis after retrieval of the IABP catheter
To achieve hemostasis after retrieval of the IABP catheter, manual compression was applied for approximately 15 min when the procedure was conducted via the femoral approach. Additional manual compression was applied when required. The Tometa-kun (Zeon Medical Corp.), a hemostatic device that enables pneumatic compression, was used when the procedure was conducted via the brachial approach.
2.5
Evaluation criteria
The evaluation parameters used included the incidence of insertion difficulty; access site complications, including hemorrhage, limb ischemia, vascular damage necessitating surgical repair, and death, including that directly related to IABP insertion; and IABP failure, including helium leakage and insufficient inflation. Severe access site hemorrhage was defined as bleeding at the balloon insertion site leading to hemodynamic compromise requiring transfusion or surgical intervention. Severe limb ischemia was defined as loss of pulse or sensation or abnormal limb temperature or pallor requiring surgical intervention. IABP failure included balloon rupture and poor helium inflation, that is, incomplete expansion of the balloon or insufficient augmentation.
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