editorial comment: arrival of femoral closure devices and the demise of brachial angiography and...

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Editorial Comment Arrival of Femoral Closure Devices and the Demise of Brachial Angiography and Interventions David A. Clark, MD Clinical Professor of Medicine Stanford University School of Medicine Stanford, California The current article by Silber et al. [1] details the successful use of hemodynamic closure devices following angioplasty by the femo- ral puncture technique. Several types of closure devices being evaluated include the vascular hemostatic device and suture mediated closure devices [2,3]. This article deals with the hemo- static puncture closure device [1], a collagen system with an intraarterial anchor, specifically as it relate to the amount of time necessary to deploy the device and achieve femoral sealing and hemostasis. A five-minute time interval is acceptable in most cases, and this obviates some of the major negatives of the femoral puncture technique, namely prolonged and uncomfortable compres- sion of the femoral artery post procedure (especially in the Reopro era) and prolonged bed rest resulting in back discomfort in most cases. From an economic standpoint, the various femoral closure devices should result in decreased patient time in specialty units, as well as decreased hospital stays. Using these devices, discharge should be appropriate within 24 hours or even on an outpatient basis in carefully selected angioplasty patients [4,5]. The current study does not demonstrate these advantages, however, with the time to mobilization in both five-minute and 30 minute deployment groups being nearly 24 hours, and the mean duration of hospital stay approaching four days. The reasons for these surprising and disappointing statistics appear to be primarily the reluctance on the part of the physician to trust the procedure and alter traditional care. The development of femoral closure devices is clearly an attempt to negate major negative aspects of the femoral puncture technique in comparison with the brachial cut down technique. That raises the question, ‘‘where has the brachial technique gone?’’ In the era of coronary angiography in the 1960s and 1970s, there was a reasonably equal split between the use of femoral and brachial techniques. There is no question that the preponderance of angiography and angioplasties are now being performed by the femoral approach. The Registry of The Society for Cardiac Angiography and Interventions demonstrates a drastic declining trend in angioplasty performed by the brachial technique (4% in 1990, 1% in 1994) [6]. We appear to be witnessing the demise of the Sones brachial cut down technique. The brachial technique was developed by F. Mason Sones, Jr., in the late 1950s at the Cleveland Clinic. Sones utilized that approach in performing his first coronary angiogram in 1958. Sones’ procedure, a surgically elegant feat, consisted of a small skin incision in the antecubital area and a smaller puncture incision of the exposed brachial artery, both of which were surgically repaired after the procedure. A single catheter was inserted and advanced to the aortic root, where it could be formed and torqued to achieve the proper shape and plane needed to selectively and coaxially intubate both left and right coronary arteries. This same catheter was used to cross the aortic valve in a retrograde manner in order to perform pressure measurements as well as left ventriculography. In properly trained expert hands, this technique was extremely rapid and safe, and it proved most beneficial to patients in terms of postprocedural comfort. In most cases, at the end of the procedure the patient could sit up, gain equilibrium, and walk from the radiographic table to the gurney. Once in the hospital room or holding area, the patient could be immediately ambulatory with supervision and go home a short time later. The same advantages held for angioplasty by the brachial technique, and while the recumbent time and hospital time in the current article do not appear to approach the brachial standard, this indeed may be due to tradition rather than practicality as noted previously. Training of Fellows to perform the Sones brachial cut down technique began in Cleveland and spread via Sones’ disciples through the midwest and eastern training institu- tions in particular. The training program consisted of at least a two-year Fellowship, which is certainly necessary to train most physicians in this elegant surgical approach. When Melvin Judkins developed and popularized the femoral multiformed catheter technique at Loma Linda, most of the trainees in the western part of the United States began to be trained by the Judkins method. This technique became popular because of the relatively short learning curve in the safe performance of the Judkins technique. Judkins often said that his catheters would find the coronary arteries unless thwarted by the physician, and, in fact, the application of torque to these catheters—a concept central to the successful Sones brachial technique—often defeats the ability to selectively and coaxially intubate the coronary arteries when Judkins-style catheters are used. We have seen many trainees who have attempted to master the Sones brachial technique but who were completely lost when trying to visualize the aortic root in three dimensions, an ability necessary to form and torque the Sones catheter to selectively reach the coronary arteries. These same students were able to quickly, adequately, and safely learn and utilize the Judkins formed catheter technique, which requires less conceptual ability and fewer tactile technical skills. Sones and Judkins engaged in legendary battles over which technique was superior in the early days of angiography. In later years, the two brilliant old warriors set aside their differences and joined together in 1978 to form The Society for Cardiac Angiogra- phy (later—‘‘and Interventions’’) in order to establish a forum for Catheterization and Cardiovascular Diagnosis 41:384–385 (1997) r 1997 Wiley-Liss, Inc.

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Page 1: Editorial comment: Arrival of femoral closure devices and the demise of brachial angiography and interventions

Editorial Comment

Arrival of Femoral ClosureDevices and the Demise ofBrachial Angiography andInterventions

David A. Clark, MD

Clinical Professor of MedicineStanford University School of MedicineStanford, California

The current article by Silber et al. [1] details the successful use ofhemodynamic closure devices following angioplasty by the femo-ral puncture technique. Several types of closure devices beingevaluated include the vascular hemostatic device and suturemediated closure devices [2,3]. This article deals with the hemo-static puncture closure device [1], a collagen system with anintraarterial anchor, specifically as it relate to the amount of timenecessary to deploy the device and achieve femoral sealing andhemostasis. A five-minute time interval is acceptable in most cases,and this obviates some of the major negatives of the femoralpuncture technique, namely prolonged and uncomfortable compres-sion of the femoral artery post procedure (especially in the Reoproera) and prolonged bed rest resulting in back discomfort in mostcases.From an economic standpoint, the various femoral closure

devices should result in decreased patient time in specialty units, aswell as decreased hospital stays. Using these devices, dischargeshould be appropriate within 24 hours or even on an outpatientbasis in carefully selected angioplasty patients [4,5]. The currentstudy does not demonstrate these advantages, however, with thetime to mobilization in both five-minute and 30 minute deploymentgroups being nearly 24 hours, and the mean duration of hospitalstay approaching four days. The reasons for these surprising anddisappointing statistics appear to be primarily the reluctance on thepart of the physician to trust the procedure and alter traditional care.The development of femoral closure devices is clearly an

attempt to negate major negative aspects of the femoral puncturetechnique in comparison with the brachial cut down technique.That raises the question, ‘‘where has the brachial technique gone?’’In the era of coronary angiography in the 1960s and 1970s, therewas a reasonably equal split between the use of femoral andbrachial techniques. There is no question that the preponderance ofangiography and angioplasties are now being performed by thefemoral approach. The Registry of The Society for CardiacAngiography and Interventions demonstrates a drastic decliningtrend in angioplasty performed by the brachial technique (4% in1990, 1% in 1994) [6]. We appear to be witnessing the demise ofthe Sones brachial cut down technique.

The brachial technique was developed by F. Mason Sones, Jr., inthe late 1950s at the Cleveland Clinic. Sones utilized that approachin performing his first coronary angiogram in 1958. Sones’procedure, a surgically elegant feat, consisted of a small skinincision in the antecubital area and a smaller puncture incision ofthe exposed brachial artery, both of which were surgically repairedafter the procedure. A single catheter was inserted and advanced tothe aortic root, where it could be formed and torqued to achieve theproper shape and plane needed to selectively and coaxially intubateboth left and right coronary arteries. This same catheter was used tocross the aortic valve in a retrograde manner in order to performpressure measurements as well as left ventriculography. In properlytrained expert hands, this technique was extremely rapid and safe,and it proved most beneficial to patients in terms of postproceduralcomfort. In most cases, at the end of the procedure the patient couldsit up, gain equilibrium, and walk from the radiographic table to thegurney. Once in the hospital room or holding area, the patient couldbe immediately ambulatory with supervision and go home a shorttime later. The same advantages held for angioplasty by thebrachial technique, and while the recumbent time and hospital timein the current article do not appear to approach the brachialstandard, this indeed may be due to tradition rather than practicalityas noted previously. Training of Fellows to perform the Sonesbrachial cut down technique began in Cleveland and spread viaSones’ disciples through the midwest and eastern training institu-tions in particular. The training program consisted of at least atwo-year Fellowship, which is certainly necessary to train mostphysicians in this elegant surgical approach.When Melvin Judkins developed and popularized the femoral

multiformed catheter technique at Loma Linda, most of the traineesin the western part of the United States began to be trained by theJudkins method. This technique became popular because of therelatively short learning curve in the safe performance of theJudkins technique. Judkins often said that his catheters would findthe coronary arteries unless thwarted by the physician, and, in fact,the application of torque to these catheters—a concept central tothe successful Sones brachial technique—often defeats the abilityto selectively and coaxially intubate the coronary arteries whenJudkins-style catheters are used. We have seen many trainees whohave attempted to master the Sones brachial technique but whowere completely lost when trying to visualize the aortic root inthree dimensions, an ability necessary to form and torque the Sonescatheter to selectively reach the coronary arteries. These samestudents were able to quickly, adequately, and safely learn andutilize the Judkins formed catheter technique, which requires lessconceptual ability and fewer tactile technical skills.Sones and Judkins engaged in legendary battles over which

technique was superior in the early days of angiography. In lateryears, the two brilliant old warriors set aside their differences andjoined together in 1978 to form The Society for Cardiac Angiogra-phy (later—‘‘and Interventions’’) in order to establish a forum for

Catheterization and Cardiovascular Diagnosis 41:384–385 (1997)

r 1997 Wiley-Liss, Inc.

Page 2: Editorial comment: Arrival of femoral closure devices and the demise of brachial angiography and interventions

invasive cardiologists to meet, discuss, and advance the scienceand art of invasive—and later interventional—cardiology.The current estimate that only 1% of angioplasty and angiogra-

phy are cases being performed by the brachial technique wouldseem accurate. Several reasons may exist for this drastic reductionin procedural volume.As noted above, a two-year training programin the brachial cut down technique is necessary to master theprocedure. Most training programs today cannot set aside thetwo-year Fellowship that is necessary to become expert in theSones approach. The arrival of the interventional cardiology era inthe late 1970s featured the remarkable developmental and teachingtalents of Andreas Gruentzig. His angioplasty catheters wereinserted by the femoral approach and had shapes similar to Judkinsangiographic catheters. Those wishing to learn the art of coronaryangioplasty did so with Gruentzig equipment. As angioplastyequipment has been revised and improved, there is no question thatthe femoral technique in angioplasty is faster, safer, and better,especially utilizing newer and bulkier adjunctive angioplastydevices such as stents, lasers, intravascular ultrasound, rotablators,and directional atherectomy.Dr. William Sheldon, a colleague of Mason Sones at the

Cleveland Clinic, reports that, sadly, the Clinic no longer includestraining in the brachial cut down technique in its Fellowshipprogram [7]. According to Simon Stertzer, who championed thebrachial approach for angioplasty, the demise is not only due to thelack of training programs, but also to the failure of cathetercompanies to redesign and improve the brachial guiding catheter tothe same refinement as femoral equipment [8]. He, like many of uswho were primarily brachial angiographers, now does the majorityof cases by the femoral approach and utilizes the brachial methodmainly for patients with lower extremity peripheral vasculardisease, which negates the ability to use that approach. Certainly,under today’s intense pressure to decrease in-hospital time and cathlab costs, the Sones brachial technique would have been popularwith hospital administrators and insurance companies (as well aspatients) had it remained in the procedural mainstream.There will always be some of us who get a special thrill from a

well-performed brachial case, but it is apparent that the femoral

technique will continue to dominate; the brachial approach will beused as an occasional alternative in specially selected cases. Oneshould never forget, however, Mason Sones and the magnitude ofhis genius that allowed him to develop the original coronaryangiography technique by the brachial approach. The tree ofinterventional cardiology with its multiple branches stands proudand tall. This tree began as a twig and was so carefully shaped andnurtured by Mason Sones and his colleagues to form the strongfoundation that is the basis for all of today’s incredible transcathe-ter therapeutic techniques.

REFERENCES

1. Silber S, Dorr R, Muhling H, Konig U: Sheath pulling immediatelyafter PTCA: Comparison of two different deployment techniquesfor the hemostasis puncture closure device. Cathet CardiovascDiagn 41:378–383, 1997.

2. Sanborn TA, Gibbs HH, Brinker JA, Knopf WA, Kosinski EJ,Roubin GS: Amulticenter randomized trial comparing a percutane-ous collagen hemostasis device with conventional manual compres-sion after diagnostic angiography and angioplasty. J Am CollCardiol 22:1273–1279, 1993.

3. Hinohara T, Vetter JW, Ribeiro E, Webb J, Carere R, Cohen E,Simpson JB: New percutaneous procedure to achieve immediatehemostasis following sheath removal. Circulation 92:1–410, 1995.

4. Cragg DR, Friedman HZ, Almany SL, Gangadharan V, Ramos RG,Levine AB, Le Beau TA, O’Neill WW: Early hospital dischargeafter percutaneous transluminal coronary angioplasty. Am J Cardiol64:1270–1274, 1989.

5. Staphorst S, Springorum B, Bollen N, Kiemeneij F: Transradialcoronary stenting in outpatients. Europ Heart J 16:169, 1995.

6. Krone RJ, Johnson L, Noto T and the Registry Committee of TheSociety for Cardiac Angiography and Interventions. Five yeartrends in cardiac catheterization: A report from the registry of theSociety for Cardiac Angiography and Interventions. Cathet Cardio-vasc Diagn 39:31–35, 1996.

7. Personal communication8. Personal communication

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