Letters to the Editor

Infectious Complications Relatedto the Use of the Angio-SealHemostatic PunctureClosure Device

TO THE EDITOR:

We have read with interest the article by Cooper andMiller entitled “Infectious Complications Related to theUse of the Angio-Seal Hemostatic Puncture Closure De-vice” published in a recent issue [1]. They reported ontwo cases of groin infections requiring surgical repairafter deployment of Angio-Seal for hemostatic punctureclosure in a series of 108 patients. As a conclusion, theauthors abandoned the use of Angio-Seal at their center.

In our own large experience with this device as theroutine tool for puncture closure after diagnostic cardiaccatheterization or coronary angioplasty since 1995, wefound no infectious complications associated with theuse of Angio-Seal in a series of 1,818 deployments [2].This is also consistent with the previously published data.In a review of the current literature [3], we found a totalof 10 cases of groin infections following the use of theAngio-Seal device in 4,965 patients (0.20%), includingthe 2 cases reported by Cooper and Miller [1]. Thisincidence is comparable to the frequency of groin infec-tions seen after conventional treatment of arterial punc-ture sites (0.05%–0.29%) [4–6].

We therefore believe that the use of the Angio-Sealdevice is not associated with an increased risk of infec-tious complications despite implantation of an intravasalforeign body. We agree with Cooper and Miller [1] thatrepeat sterilization of the puncture site should be appliedand strict sterile deployment of the device is required in

order to minimize the risk of infectious complications, asis performed in our institution.

In the view of the safety and efficacy of the Angio-Sealdevice reported in several randomized and observationalstudies, abandoning of the device from daily practicedoes not seem to be justified.

Holger Eggebrecht, MDMichael Haude, MDDietrich Baumgart, MDRaimund Erbel, MDDepartment of CardiologyDivision of Internal MedicineUniversity Hospital EssenEssen, Germany

REFERENCES

1. Cooper CL, Miller A. Infectious complications related to the use ofthe Angio-Seal hemostatic puncture closure device. Cathet Cardio-vasc Intervent 1999;48:301–303.

2. Lübkemann H, Haude M, Görge G, Baumgart D, Ge J, Dagres N,Sack S, Welge D, Mahr P, Erbel R. Immediate closure of femoralartery puncture site after cardiac catheterization by a new collagen-anchor device (Angio-Seal): results in 1818 consecutive patients.Am J Cardiol 1997;80:255.

3. Eggebrecht H, Haude M, Baumgart D, Oldenburg O, Herrmann J,Bruch C, Hunold P, Neurohr C, von Birgelen C, Welge O, KatzMA, Erbel R. Hemostatic puncture closure using Angio-Seal™after diagnostic cardiac catheterization or coronary angioplasty.Herz 1999;24:607–613.

4. Klinke NP, Kubac G, Talibi T, Lee SG. Safety of outpatient cardiaccatheterization. Am J Cardiol 1985;56:639–641.

5. Muller DWM, Shamir KF, Ellis SG, Topol EJ. Peripheral vascularcomplications after conventional and complex percutaneous inter-ventional procedures. Am J Cardiol 1992;69:63–68.

6. Kern MJ, Cohen M, Talley JD, Litvack F, Serota H, Aguirre F,Deligonul U, Bashore TM. Early ambulation after 5 F diagnosticcardiac catheterization: results of a multicenter trial. J Am CollCardiol 1990;15:1475–1483.

Catheterization and Cardiovascular Interventions 49:352–355 (2000)

Published 2000 Wiley-Liss, Inc.

Infectious Complications Relatedto the Use of the Angio-SealHemostatic Puncture ClosureDevice

TO THE EDITOR:

We appreciate the comments by Eggebrecht et al.pertaining to our article [1]. Our experience with infec-tious complications related to the use of the Angio-Sealdevice appears to differ with his group [2]. The reasonfor this is unclear. In our opinion, poor sterile techniqueand user inexperience did not contribute to our observa-tions. Our center performs approximately 2,500 angio-graphic procedures per year. Aside for the infectiouscomplications reported in our article, no cases of endar-teritis have been observed at our center in 10 years. It islikely that any cases not captured by the angiographyteam would have been recorded by the infectious dis-eases section at our center. The referenced abstract doesnot report the percent of angiographed patients receivingfollow-up assessment. It is possible that the low numberof infectious complications observed may be a product ofunderreporting secondary to limited follow-up as op-posed to a true absence of events.

We once again emphasis the need for strict adherenceto sterile technique when using this device. Although thesafety record of Eggebrecht et al. is compelling, weremain leery to use this device based on the high inci-dence of bleeding and infectious complications observedat our center.

Curtis Cooper, MDDepartment of Internal Medicine,Section of Infectious Diseases,University of Ottawa,Ottawa, Ontario, Canada

A. Miller, MDDepartment of Internal Medicine,Section of Cardiology,Saint Boniface Hospital,Winnipeg, Manitoba, Canada

REFERENCES

1. Cooper CL, Miller A. Infectious complications related to the use ofthe Angio-Seal hemostatic puncture closure device. Cathet Cardio-vasc Intervent 1999;48:301–303.

2. Lubkemann H, Haude M, Gorge G, Baumgart D, Ge J, Dagres N,Sack S, Welge D, Mahr P, Erbel R. Immediate closure of femoralartery puncture site after catheterization by a new collagen-anchordevice (Angio-Seal): results in 1818 consecutive patients. Am JCardiol 1997;80:255.

Transradial Technical Tips

TO THE EDITOR:

The recent report by Caputo et al. [1] has added to thebody of literature describing success with the radial ar-tery approach. At our institution, we had never excludedpatients with prior brachial cutdowns from radial arterycatheterization and have additional experience with quitea few of these patients. As the authors noted, patientswith prior cutdowns usually have an outcome no differ-ent from the routine radial artery catheterization.

Two of the complications that they noted—the inabilityto insert arterial introducer sheath due to spasm and thefailure to advance the catheter due to brachial artery occlu-sion—can frequently be overcome by using hydrophilic-coated equipment. There are hydrophilic-coated sheaths(e.g., Flexor Check-Flo Performer Introducer Set with hy-drophilic coating, Cook, Bloomington, IN) that in our ex-perience almost universally pass into any radial artery that awire can pass. In addition, the hydrophilic surface preventsthe radial artery’s tendency to grip the introducer and makeremoval potentially painful at the conclusion of the proce-dure. Brachial artery occlusions, or more frequently a ste-

nosis at the site of cutdown, may prevent standard 0.350guidewires from passing. Again, in most of these circum-stances, we have found that the use of a hydrophilic wire(e.g., 0.350 Glide wire, Meditech, Watertown, MA) permitsupstream access to the central arterial system. Once thestandard 6 Fr angiographic catheter has passed through thenarrowed brachial cutdown site over the hydrophilic wire,further catheter exchanges can be accomplished with stan-dard, nonhydrophilic 0.350 angiographic wires.

The transradial approach to cardiac catheterization isan exciting approach that continues to evolve into both amore operator- and patient-friendly technique as bothclinical experience develops and technology improves.The experience of Caputo et al. [1] supports our enthu-siasm for this technique.

Ian C. Gilchrist, MDPennsylvania State UniversityHershey, Pennsylvania

REFERENCE

1. Caputo RP, Simons A, Giambartolomei A, Grant W, Fedele K, EsenteP. Transradial cardiac catheterization in patients with prior brachialartery cutdown. Cathet Cardiovasc Intervent 1999;48:271–274.

Letters to the Editor 353

REPLY TO THE LETTER TO THE EDITOR BYGILCHRIST:

I am encouraged to see that there has been significantsuccess in performing transradial catheterization in pa-tients with prior brachial cutdowns at an institution otherthan ours. I commend Dr. Gilchrist for his efforts in thisregard. I do, however, have a slight difference of opinionin regard to the use of hydrophilic-coated wires as well asthe possible utility and safety of pursuing the transradialapproach in patients who have had a prior brachial cut-down in whom significant resistance at the level of thebrachial cutdown is encountered. First, it has been myexperience and the experience of several people in Eu-rope that the use of hydrophilic wires does present somehazard when utilized from the transradial approach. Suchwires frequently find their way into small side branchesand, unless fluoroscopic guidance is used when passing

these wires through the arm and great care is taken, thereis a risk of side-vessel perforation. Second, while wehave not encountered this problem, I would be very waryof performing aggressive manipulations within a totallyoccluded or near totally occluded brachial artery. Thiswould be of greatest concern in an artery that had had arecent cutdown performed on it. Having significant ex-perience with performing repeated cutdown procedures, Ihave noticed that the brachial artery can be extremelyscarred and fibrotic in these circumstances and thiswould increase the risk for arterial perforation. In suchpatients I would favor the use of a contralateral radialapproach or femoral approach.

Ronald P. Caputo, MDSJH Cardiac Catheterization AssociatesSyracuse, New York

LETTER TO THE EDITOR: REMADHUSOODANAN ET AL.

We read with interest the article by Madhusoodanan etal. entitled “Inadvertent Stenting of Left Main CoronaryArtery Complicated by Later In-Stent Restenosis” [1].The authors ponder about the causes for the migration ofa Wiktor stent from the ostium of the ramus in the distalleft main, following its proper predeployment positioningas demonstrated in Figure 1. It is indeed this same figurewhich shows that the reason for the proximal displace-ment of the stent following its proper positioning is mostprobably the instability of the entire angioplasty systemat the time of stent deployment.

The guiding catheter is not engaged in the left mainand its tip is in fact located in the left coronary cusp,inferior to the ostium of the left main. In addition, the

floppy tip of the guidewire is looped in the proximalportion of the ramus, just distal to the stent, with only aminimum, if any, of its solid component supporting thedistal end of the stent delivery system. With such asystem in place, any movement of the guiding catheterwill result in a displacement of the stent as occurred inthis patient.

Yves Janin, MDThe Cardiovascular SpecialistsMemphis, Tennessee

REFERENCE

1. Madhusoodanan KP, Javeed N, Marakovits J, Warner MF, MissriJC. Inadvertent stenting of left main coronary artery complicated bylater in-stent restenosis. Cathet Cardiovasc Intervent 1999;48:194–197.

CORONARY ARTERY FISTULA CLOSURE IN ANINFANT

I read with interest the report on transcatheter closureof a large coronary artery fistula with the amplatz ductoccluder in an 8-month-old anymptomatic boy [1]. Hispulmonary artery pressure was 24/12 mm Hg, and thepulmonary/systemic flow ratio was 1.36. The left ventri-cle size was not mentioned. The authors should be com-plimented for their technical excellence, but I am surethat many, like me, would not be convinced of thedesirability of such an intervention in this scenario. Iwould like to ask the clinically relevant question, “Youcan, but should you?” especially as such coronary artery

fistulas are shown to have a relatively long asymptomaticbenign course [2].

S.S. KothariCardiothoracic CentreAll India Institute of Medical SciencesNew Delhi, India

REFERENCES

1. Thomson L, Webser M, Wilson N. Transcatheter closure of a largecoronary artery fistula with the amplatzer duct occluder. CathetCardiovasc Intervent 1999;48:188–190.

2. Sherwood MC, Rockenmacher S, Colan SD, Geva T. Prognosticsignificance of clinically silent coronary artery fistula. Am J Cardiol1999;83:407–411.

354 Letters to the Editor

Radiation Exposure to ChildrenDuring Transcatheter Occlusionof the Patent Ductus Arteriosus

LETTER TO THE EDITOR

We read with interest the recent article by Moore et al.[1]. In their study, surface entrance radiation doses weredetermined during coil occlusion of patent ductus arteri-osus (PDA) in eight consecutive patients. Total cumula-tive doses (postero-alterior (PA) and lateral dose) werecalculated for each patient. Entrance and cumulativeradiation doses were also determined in the same way in12 patients undergoing standard diagnostic catheteriza-tion and in 5 consecutive patients undergoing pulmonaryballoon valvuloplasty.

No significant difference was found between the threegroups in entrance or in total radiation cumulative dose.The mean total fluoroscopy time in the PDA group(10.1 6 1.8 min) was comparable to the diagnosticcatheterization group and was significantly less than thatof the valvuloplasty group. Collectively, no correlationbetween fluoroscopy time and entrance radiation dosewas observed. A significant correlation between bodysurface area or weight and total radiation cumulativedose was found in all groups of patients.

The authors concluded, “No increased radiation risksare imparted form PDA occlusion as compared to theother accepted catheterization procedures.” In addition,the authors stated, “Fluoroscopy time alone provides apoor estimate of the potential radiation risk encounteredby patients during catheterization procedures.” The au-thors discussed the limitations of their study. However,in addition to the limitations mentioned by the authors,we believe that the important limitation of the study isrelated to the fact that complete PDA closure wasachieved in each patient with a single Gianturco coil.Crucial data regarding PDA closure (the PDA size andtype) were not reported in the study. We presume thatmost PDA in the study were of a small minimal diameter(,2 mm). For the closure of moderate- and large-sizedPDA (minimal diameter.2 mm), the multiple coil oc-clusion technique is necessary. Using the multiple coilocclusion technique, fluoroscopy times are roughly pro-portional to the number of implanted coils. For compar-ison, Hijazi and Geggel [2] reported the median fluoros-copy time of 40 min (range 13–152 min) in a group of

patients with large-sized PDA (minimal diameter.4mm). Therefore, for closure of moderate- and large-sizedPDA (particularly in heavier and taller patients), radia-tion exposure is probably much higher than determinedin the study. In our opinion, conclusions related to radi-ation exposure to children during coil occlusion of PDAin the article by Moore et al. [1] apply only for patientswith small-sized PDA. The conclusions remain to beproved for closure of moderate- and large-sized PDA.

To reduce radiation exposure for the individual patientto a minimum and to avoid other drawbacks of themultiple coil occlusion technique, we adopted a novelapproach for the percutaneous closure of PDA [3]. Weselect coils (detachable Cook PDA coils) only for closureof small-sized PDA (minimal diameter,2 mm) andresidual PDA after surgical ligation. For closure of mod-erate- and large-sized PDA (minimal diameter.2 mm),we implant Amplatzer duct occluders (ADO) [4]. In ourseries of 54 patients, the median fluoroscopy time usingboth types of occluders was only 12 min (range 4–47min). Minimal PDA diameter in the study ranged from1.1 to 7.5 mm (median 1.7 mm in the coil group and 3.8mm in the ADO group). Overall closure rate in the studywas 98%. Trivial residual shunt persisted in a singlepatient in the coil group.

TomazPodnar, MDPavol Gavora, MDJozef Masura, MD, PhDChildren’s Cardiac CenterUniversity Children’s HospitalBratislava, Slovakia

REFERENCES

1. Moore JD, Shim D, Sweet J, Arheart KL, Beekman RH. Radiationexposure to children during coil occlusion of the patient ductusarteriosus. Cathet Cardiovasc Intervent 1999;47:449–454.

2. Hijazi ZM, Geggel RL. Transcatheter closure of large patent ductusarteriosus (.4 mm) with multiple Gianturco coils: immediate andmid-term results. Heart 1996;76:536–540.

3. Podnar T, Gavora P, Masura J. Percutaneous closure of patentductus arteriosus: complementary use of detachable Cook patentductus arteriosus coils and Amplatzer duct occluders. Eur J Pediatr(in press).

4. Masura J, Walsh KP, Thanopoulous B, Chan C, Bass J, GoussousY, Gavora P, Hijazi Z. Catheter closure of moderate- to large-sizedpatent ductus arteriosus using the new Amplatzer duct occluder:immediate and short-term results. J Am Coll Cardiol 1998;31:878–882.

Letters to the Editor 355