Feasibility of 6 Fr Intra-Aortic Balloon Pumping Via the Femoral or Brachial Approach

Abstract: Objectives. To demonstrate safety and efficacy of new 6 Fr intra-aortic balloon pumping (IABP) system. Background. Access-site complications have been reported to increase adverse events following PCI. Some reports have shown access-site complications in conventional 8-Fr compatible IABP system. The new 6 Fr IABP system may reduce the complication rate due to the smaller size. Methods. We extracted medical records for patients who underwent elective percutaneous coronary intervention under prophylactic 6 Fr or 8 Fr IABP assistance from January 2006 to December 2009 at Tokai University School of Medicine. The clinical outcomes were compared between 6 Fr and 8 Fr or between transfemoral and transbrachial IABP. Results. A total of 42 cases were extracted, including 20 cases using 6 Fr IABP (47.6%) and 22 cases using 8 Fr IABP (52.4%). The 6 Fr IABP included 15 cases of transbrachial approach (75.0%) and 5 cases of transfemoral approach (25.0%). All cases of 8 Fr IABP were via transfemoral approach. The bedrest time was clearly shorter in the 6 Fr IABP group (75.8 ± 139.8 minutes vs 360.0 ± 104.7 minutes in the 8 Fr IABP group; P<.001). Bedrest time and duration of hospitalization were shorter in the transbrachial IABP group (0.0 ± 0.0 minutes and 1.0 days [interquartile range, 1.0-2.0 days] vs 288.0 ± 107.3 minutes and 5.0 days in the transfemoral group [interquartile range, 3.0-8.0]; P<.001). Access-site complications were 0% with the 6 Fr system, but 13.6% with the 8 Fr IABP system. Conclusions. This study demonstrated that the 6 Fr IABP system and its transbrachial application may be feasible because of lower complication rates.

J INVASIVE CARDIOL 2012;24(12):641-644

Key words: high-risk PTCA, complications, hemodynamics

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Recent remarkable developments in percutaneous coronary intervention (PCI) devices have made it possible to treat more severe lesions. On the other hand, hemodynamic instability is still a problem in patients with high-risk coronary anatomy. Assisted circulation devices to stabilize hemodynamic status, such as intra-aortic balloon pump (IABP), are necessary in these cases undergoing PCI.^1-3

However, the conventional IABP system has some limitations, such as bleeding complications due to bigger size and application only via the femoral approach but not the transradial or transbrachial approach. Access-site complications have been reported to increase adverse events following PCI.^4,5

To study feasibility of a new 6 Fr IABP system via femoral or upper limb approach, we retrospectively analyzed the clinical data.

Methods

Study population. We extracted cases from medical records representing patients who underwent elective PCI under prophylactic IABP assistance from January 2006 to December 2009 at Tokai University School of Medicine. Cases where IABP was needed because of hemodynamic deterioration were excluded. Also, IABP was inserted with stable hemodynamics before PCI for the purpose of prophylactic use in all of the study cases.

IABP systems. Two different IABP systems were used in this study: a new, slenderized, 6 Fr IABP system (Takumi; Zeon Medical) and a conventional 8 Fr IABP system (TRUE8-Super Track; Datascope Corp., 2009). Selection of either system was at operator discretion.

The 6 Fr IABP can be applied via the left brachial artery (Figure 1). Before inserting the 6 Fr IABP, the aortic arch was screened by computed tomography (CT) angiography or aortic angiography. If the aorta or left subclavian artery had severe tortuosity, the brachial application was not performed. The IABP was removed at the end of PCI. However, cases in which the operator decided to continue IABP after PCI were classified as unstable hemodynamic cases and were excluded from this study. In removing transbrachial IABP (TB-IABP), hemostasis was achieved with manchette compression. In cases of transfemoral IABP (TF-IABP), the closure device (Angio-Seal; St. Jude Medical), which accomplishes hemostasis by sandwiching the puncture site between a bioabsorbable anchor and collagen sponge, was used.

PCI strategy. PCI approach site was selected between right radial and femoral artery. Interventional strategy including choice of appropriate approach site or usage of other devices for the achievement of procedural success was decided by well-experienced operators. During the procedure, a sufficient dose of unfractionated heparin was administrated to keep activated clotting time >250 seconds, checking every hour following the initial administration of 1000 U/kg of body weight. 

In removing the femoral sheath after PCI, hemostasis was achieved by closer device. In transradial coronary intervention, (TRI), a compression device (Adapty; Medikit) was used after holding a styptic pad (Axcel; Alliance Medical Group) between the puncture site and this device.

Statistical analyses. Numerical factors with normal distribution are shown as mean ± standard deviation. Numerical factors with skewed distribution are shown as median (interquartile range). Clinical parameters were tested for significant differences between two groups with the student’s t-test. One-way analysis of variance (ANOVA) was used to compare averages among more than three groups. Fisher’s exact test was applied to determine the difference between two or more categorical variables. All statistical calculations were done using SAS version 9.1.3 (SAS Institute, Inc).

Results 

See Table 1 for details regarding approach site and IABP size-specific comparisons of baseline characteristics and clinical outcomes between 6 Fr and 8 Fr IABP groups, or between 6 Fr TB-IABP, 6 Fr TF-IABP, and 8 Fr TF-IABP groups. Two cases in each group (a total of 4 cases) were excluded from this study due to post-hemodynamic instability. Consequently, 42 cases were enrolled in this study. 

The average age was 71.2 ± 8.3 years and 76.2% were male. All cases received dual-antiplatelet therapy before PCI. Procedural success was achieved in 100%. The major reason for prophylactic IABP was a lesion related to the left main trunk in over 90% of cases; the others were due to triple-vessel disease.

In comparisons between 6 Fr and 8 Fr IABP, the 6 Fr IABP system was used in 20 cases and the 8 Fr IABP system was used in 22 cases. In the 8 Fr IABP group, IABP was inserted via femoral artery in all 22 cases. By contrast, in the 6 Fr IABP group, the IABP was inserted via brachial artery in 75% of cases. PCI was performed via transradial approach in 50% of the 8 Fr IABP group, but transradial PCI occurred in 95% of the 6 Fr group (P<.001). Bedrest time was significantly shorter in the 6 Fr group than the 8 Fr group (75.8 ± 139.8 minutes vs 360.0 ± 104.7 minutes; P<.001). IABP access-site complications were 0% in the 6 Fr IABP group, but 13.6% in the 8 Fr IABP group.

We also made comparisons among 6 Fr TB-IABP (n = 15), 8 Fr TB-IABP (n = 5), and 8 Fr TF-IABP groups (n = 22). Bedrest time was significantly shorter in the TB-IABP group than in the TF-IABP group (0 minutes vs 340.0 ± 104.9 minutes; P<.001). Duration of hospital stay was significantly shorter in the TB-IABP group than in the TF-IABP group (1.4 ± 0.6 days vs 5.4 ± 7.1 days; P=.04).

Discussion

We studied clinical benefits and adverse events of the 6 Fr IABP system by comparison with the conventional 8 Fr IABP system. The 6 Fr IABP system was superior to 8 Fr IABP in terms of shorter bedrest time. TB-IABP was superior to TF-IABP in terms of shorter bedrest time and shorter hospital stay. No adverse events were observed in the 6 Fr IABP system.

Bleeding complications, especially at access sites, have been reported to increase adverse outcomes following PCI.^4,5 Efforts to reduce bleeding complications may improve the total outcome of PCI. It is well known that smaller-caliber sized catheters are superior in terms of lower procedural complications.^6-8 In this study, the access-site complication rate was 0% with the 6 Fr IABP system. The incidence of access-site complications with the 8 Fr IABP seemed high. This may be due to the fact that the actual arteriotomy hole was larger than 8 Fr due to the unwrapped balloon. Closure device use might have resulted in a lower rate of access-site bleeding. Shorter bedrest time and less reduction of hematocrit are considered advantageous compared to the 8 Fr system.

Conversely, the 6 Fr IABP system has a limitation, since this system cannot measure the aortic pressure due to the extremely small inner guidewire lumen. But no adverse events were reported because blood pressure can be monitored via a guiding catheter during PCI. Thus, the 6 Fr IABP is a good assisting device during PCI. However, it may be a major limitation using the IABP in the Intensive Care Unit. Moreover, balloon actuation time and fluoroscopy times were higher in the 6 Fr IABP. Difference of procedural time between transradial and transfemoral intervention, or difference in the time to IABP setup, might impact on this difference.

Transbrachial application is one of the attractive points of the 6 Fr IABP system. Some cases with TB-IABP using conventional 7.5 Fr or 8 Fr IABP systems have been reported.^9-13 The outer sheath diameter of the 6 Fr IABP system that we used in this study is 2.52 mm; the outer sheath diameter of the 8 Fr IABP system was 3.26 mm. We previously reported that the mean lumen diameter of the brachial artery was 4.53 ± 0.62 mm.¹⁴ Either 6 or 8 Fr can be applied to the brachial artery in terms of the arterial size; however, 6 Fr IABP may be safer because of the high complication rate in the brachial artery puncture.¹⁵ However, there are several limitations to TB-IABP. Some anatomical variation of left subclavian artery limits the indication of TB-IABP. TB-IABP should be avoided in cases with subclavian arterial stenosis, and cases with so-called type III arch. Checking the arch anatomy is important for safe TB-IABP. Moreover, it might limit the applicable case that their balloon size is 30 cc only.

Study limitations. There are several limitations in this study. This was a retrospective study and included a relatively small sample. This sample size might explain why we did not see statistically significant differences in IABP access-site complications. To our knowledge, there has been only one case report in the literature.¹⁶ Thus, this study is the largest sample size report on the new 6 Fr IABP system. Our data may suggest the safety and feasibility of this system at present despite the limitations of this system.

In conclusion, the 6 Fr IABP system is feasible in clinical use and advantageous in terms of lower access-site complications. TB-IABP application is also possible using this system to achieve shorter bedrest time and shorter hospital stay. 

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From the Division of Cardiology, Tokai University School of Medicine, Isehara, Japan.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.

Manuscript submitted June 4, 2012, provisional acceptance given June 19, 2012, final version accepted June 28, 2012

Address for correspondence: Yuji Ikari, MD, PhD, Professor of Medicine, Department of Cardiology, Tokai University School of Medicine, 143 Shimokasuya, Isehara, 259-1193, Japan. Email: ikari@is.icc.u-tokai.ac.jp