Doing more with less is focal point at ACS

BBI Newsletter, The, Nov, 1997

By CYNTHIA DRAKE BBI Contributing Writer CHICAGO, Illinois - Doing more with less may be the oversimplified mantra of the U.S. health care indus-try in the 1990s, but in the surgical field, its application is much more literal than figurative. Minimally inva-sive cardiac surgery techniques, alternative breast biop-sy methods and sutureless wound closures were among the "more with less" approaches discussed during the annual gathering of the American College of Surgeons (ACS; Chicago), held here in mid-October.

During a panel discussion that highlighted the first general session of the ACS meeting, Valavanur Subra-manian, MD, of Lenox Hill Hospital and Medical Center (New York), explained to attendees why the issue of minimally invasive cardiac surgery is "hot." According to Subramanian, the procedure "contains costs, is com-petitive to PTCA and stents. It will also be increasingly useful for those patients over 65 years who are making up more and more of our patient load." He added, "a paradigm shift in cardiac surgery is occurring and we are seeing the need for 'total revascu-larization' reexamined." As Subramanian noted, with these new minimal techniques, cardiac care teams may elect to perform "appropriate revascularization" techniques recognizing that reoperative procedures would be feasible if needed. "Appropriate" may, in some instances, mean a beating-heart CABG for the left anterior descending artery com-bined with PTCA and stents for other coronary arteries. Delos Cosgrove, MD, of the Cleveland Clinic Foundation (Cleveland, Ohio), spoke of his series of 451 cardiac valve cases done through a 3" T-shaped sternal incision. His team's most recent improvements to these minimally invasive procedures involve vacu-um- assisted venous drainage, use of CO2 to reduce microbubbles, and use of a 22 French vena cava cannu-la. Cardiopulmonary bypass (CPB) with aortic and vena cava cannulation is used routinely. Panel moderator W. Randolph Chitwood, MD, of East Carolina University (Greenville, North Carolina), described his new technique of video-assisted micro thoracotomies for valve replacement. His team uses femoral-to-femoral CPB cannulation. Chitwood's series had 50% reduction of ICU stay, a mean length of stay of 3 days and a 34% reduction in total hospital costs. John Stevens, MD, of Stanford Medical Center (Stanford, California), described results of his team's series of 1,000 cardiac patients treated using the arrest- ed heart, femoral-to-femoral CPB technique. Of the total series, 75% were CABG and 97% of those were multi-vessel. The remaining 25% of the procedures were valve and congenital heart cases. As he described the beating heart technique: "It is not limited to single ves-sels. It is not done in a shorter time (his team is record-ing operative times 20% to 30% longer than open pro-cedures, but dropping). It is not less labor-intensive." Stephens' team is performing routine completion angiography in the OR at the close of the CABG. The surgeon can then be assured his anastamosis is patent before moving the patient to the recovery area. The Stanford team is reporting routine discharge on post-op day two. As the panel concluded and questions were taken from the floor, moderator Chitwood leaned over the podium and looked down at the front row of the audi-ence. "Let's ask the man who started these CABG pro-cedures and who has probably done more than any of us. 'How would you have your CABG done, Dr. Cooley?'" Denton Cooley, MD, Texas Heart Institute (Houston, Texas), took a moment, then drawled, "If it were me, I'd go see Dr. Subramanian." The needle or the knife? The ACS has more than 55,000 fellows, including more than 3,300 members in countries other than the U.S. It is the largest organization of surgeons in the world. More than 20,000 of these members are active general surgeons. Treatment of breast disease is one of these specialists' most common surgical procedures. An estimated 1,000,000 excisional breast biopsies were per-formed in the U.S. in 1996. Like cholecystectomies, these procedures are being replaced by alternative min-imally invasive techniques. Fine needle biopsy and soft tissue "core" biopsy techniques are being refined. Whether stereotactically- or ultrasonically-guided, they are reducing the number of breast biopsies performed in operating rooms. Excisional biopsy can produce undesirable cosmet-ic defects - scarring, dimpling, or retraction of the nip-ple or surrounding breast tissue. Future evaluation of the breast may be complicated. "If the patient has a hematoma after the biopsy, this portion of the breast could be more difficult to assess, especially if the patient ends up with cancer in the biopsy scar," accord-ing to V. Antoine Keller, MD, of Tulane Medical School (New Orleans, Louisiana). Stereotactic systems such as the ABBI (Advanced Breast Biopsy Instrumentation) System from U.S. Surgical Corp. (USSC; Norwalk, Connecticut), the Mammotome Biopsy System from Biopsys Medical (Irvine, California), the SiteSelect from Imagyn Medical Technologies (Newport Beach, California) and the Surcore from Interventional Con-cepts (Tampa, Florida) enable the surgeon to perform "core" biopsies of the affected breast. Complete removal of mammographically detected breast lesions can be accomplished in the radiology department using these systems in lieu of an open procedure in an oper-ating room. The ABBI system is a joint project of USSC and Lorad (Danbury, Connecticut) and consists of a Lorad stereotactic table with an ABBI sampling device. The ABBI is a 20 mm plastic cannula containing a rotating circular blade, powered by an electric motor, that makes an oscillating cut within the plastic sleeve of the cannula. The surgeon controls the rate and depth of in-sertion. The Biopsys Mammotome uses vacuum assistance in a high-speed rotating cutter. Using stereotactic or ultrasound guidance, the probe is positioned in the breast to align the aperture in the probe with the breast lesion. Tissue is gently vacuum-aspirated into the aper-ture and the rotating cutter is advanced forward, cut-ting and capturing a specimen. The needle's aperture is rotated inside the breast to accomplish contiguous sam-ple acquisition. The cutter is withdrawn, moving the specimen to a tissue collection chamber while the outer probe remains in the breast. A Micromark radiolucent clip may be left within the breast as a marker for future examinations. The SiteSelect biopsy system from Imagyn Medical provides the surgeon with a single extensive sample, but its design limits the extent of healthy tissue removed. As the probe is advanced through the breast tissue, dissection occurs on one plane while healthy tis-sue is pushed aside. A localization needle is advanced to the lesion and a garrote wire transects the tissue. The lesion is then removed through the cannula. Interventional Concepts' Surcore soft tissue biop-sy system has an integral trocar. This system has a nee-dle carrier and needle assembly on a track. As the device mount/blade guide is moved along the track, the needle is properly positioned. The needle is with-drawn from the introducer and a tension wire is passed into the tissue. The biopsy device is then advanced with a rotating motion. An electro-surgery cable is attached to the device and electrical current is used to sever the tissue sample. The biopsy device remains in place and can serve as a trocar to facilitate additional tissue removal via a 5 mm biopsy forceps, electrocautery. Fiberoptic endoscopes can also be placed within the tro-car. The system is not yet FDA-approved. As stereotactic tables allowed breast biopsies to be done in the radiology department, so ultrasound equip-ment is moving the procedures into the surgeon's office. The Sonopsy ultrasound-guided breast biopsy system from NewVision (Seattle, Washington; recently acquired by USSC) features a chair-like positioning device with a small footprint. The Sonopsy stabilizes the breast and biopsy device and allows easy targeting of the breast lesion, reducing the time required to per-form the procedure by about 66%. Once the patient is seated in the chair and the breast is stabilized, the ultra- sound scanner is rotated to orient the lesion and position the patient. An automatic 3-D ultrasound scan is done and the images are used to locate the area of interest. Once the desired scanning plane is selected the system automatically calculates the coordinates for positioning of the biopsy guide. A local anesthetic is injected and a skin incision made. Real-time scans are done as the nee-dle is inserted and positioned. The tissue sample is taken and the needle removed. Positioning with the Sonopsy allows proper correlation with previous mammograms. The system requires approximately six minutes of sur-geon time and retails for about $75,000. Enterprising sur-geons might also choose to do office breast biopsies using small portable ultrasound systems such as the Scanner 100LC from Pie Medical Equipment BV, the Netherlands. This 20-pound device is distributed in the U.S. by Leisegang Medical (Boca Raton, Florida). No more stitches? All 55,000 ACS fellows place sutures and close wounds. So do trauma physicians, family practitioners and even nurse practitioners. Worldwide, an estimated 90 million topical wound closures occur each year. As Table 6 shows, 56% of these wounds are surgical, 16.9% are from minimally invasive procedures and 24.4% are emer-gency room closures. The 3.1% remaining are plastic and reconstructive procedures. Companies like Closure Medical (Raleigh, North Carolina) and Sherwood-Davis & Geck (St. Louis, Missouri) are among those planning to close wounds with something other than suture. A group of adhesives called cyanoacrylates were first described in 1949. They polymerize in an exother-mic reaction on contact with a fluid or basic substance, forming a strong bond. Several cyanoacrylate monomers have been developed over the years as tis-sue adhesives, but clinical use was limited because of the product's low tensile strength. Butylcyanoacrylates are effective but limited, according to James Quinn, MD, et al., of the University of Michigan School of Medicine (Ann Arbor, Michigan), in an article in the May 21, 1997, issue of JAMA. After polymerizing, the butyl derivatives become brittle and are subject to frac- ture if used over skin creases, on long lacerations or on areas of movement. Closure Medical's product Dermabond is an octyl-cyanoacrylate. It incorporates a longer-chain formulated cyanoacrylate - a combination of monomer and plasti-cizers - that forms a strong flexible bond. Quinn and his associates studied patients with facial lacerations and some with extremity and torso lacerations. They found this adhesive to be as effective as 5-0 monofilament suture for these indications. When used properly for topical wound closure, this tissue adhesive resulted in fewer foreign-body reactions than sutures. Quinn also noted a potential for decreased infection rates in conta-minated wounds. No follow-up visit for suture removal is needed. Dermabond is distributed by Ethicon Inc. (Somerville, New Jersey), a subsidiary of Johnson & Johnson (New Brunswick, New Jersey). The product is packaged in a sterile single-use blister pack. After an ini-tial squeeze to crush the inner ampule, the adhesive moves to the applicator tip and can be painted onto the wound where it forms a strong flexible coating. Use of Dermabond in emergency room wound clo-sures was shown to reduce physicians' time by more than 60%. The product is expected to lower material costs for wound closure by as much as 30% and overall procedure costs by more than 50%. At $18.75 per unit to Johnson & Johnson, Dermabond will address a poten-tial worldwide annual market of $1.725 billion. The present worldwide market for sutures and staples for both topical and internal applications is estimated at $2.6 billion and is projected to grow 8.5% annually through 1998. During ACS, Sherwood-Davis & Geck, a sub-sidiary of American Home Products (Madison, New Jersey), announced an exclusive global marketing alliance with Loctite Corp. (Hartford, Connecticut) for the promotion and distribution of Loctite's Indermil precision wound closure system. The Indermil system consists of a terminally sterilized topical tissue adhe-sive, a proprietary electronic delivery system and ster-ilized kits for use in clinics and emergency depart-ments, ambulatory care and surgical centers as well as operating rooms. The tissue adhesive is based on a proprietary n-butyl cyanoacrylate. Sherwood-Davis & Geck expects to begin sales of the CE-marked product immediate-ly in Europe. Sales in the U.S. await FDA approval. Another type of tissue adhesive - fibrin-based glue - has been used for years in Europe, Canada and Japan. These tissue adhesives are made from fibrin and throm-bin, components of the body's natural heal-ing process. They are not available commer-cially in the U.S. because the FDA has been concerned about the risk that these adhe-sives, formed from plasma collected from hundreds of donors, might spread viral diseases such as hepatitis or AIDS, according to William Spotnitz, MD, of Virginia Health Sciences Center (Charlottesville, Virginia). Spotnitz nevertheless believes there will be major breakthroughs in the use of fibrin tissue adhe-sives in the next 5 to 10 years. "As soon as surgeons are allowed to use glues in effective ways, there is going to be a wide variety of new applications," he says. One reason for the growing acceptance of fibrin tissue adhe-sives is the development of antiviral technology that prevents the transmission of viruses from pooled plas-ma. Another option is to prepare fibrin tissue adhesives autologously, from the patient's own blood. During ACS, researchers from Spotnitz's Tissue Adhesive Center reported on recent tests of Quixil from Omrix Biopharmaceuticals SA (Brussels, Belgium). This product is a spray containing highly concentrated cryopre-cipitated human clottable proteins including fibrinogen and human thrombin. Used after knee replacement surgery in animals, Quixil fibrin adhesive reduced post-op bleeding by more than 50%. In a separate study of 40 women, University of Virginia (Charlottesville, Virginia) investiga-tors found that Vitex tissue adhesive from V.I. Technologies (New York) significantly reduced drainage after breast lumpectomy and axillary lymph node dissection. Managing electrosurgical risks As minimally invasive procedures continue to evolve, they bring their own set of problems. As an example, electrosurgical injuries during minimally invasive surgical procedures continue. Use of monopo-lar electrosurgery, while versatile and almost universal-ly available, can expose patients to safety risks. While the incidence of stray electrical energy burns is fairly low, the extreme severity of the complications, com-bined with the practice of discharging seemingly healthy patients soon after minimally invasive proce-dures using electrosurgery, can result in serious legal ramifications for surgeons and hospitals. Some insurance companies are offering malpractice discounts of up to 7.5% to surgeons who take educa-tional courses in the use and abuse of electrical energy. Currently, the only way to eliminate patient injury due to stray electrical energy is to use active electrode mon-itoring, a shielding and monitoring system that inter-faces with electrosurgical units (ESUs) to help detect and manage stray electrical energy. This safety device from ElectroScope (Boulder, Colorado) will shut down the ESU if a stray electrical energy leak occurs. Surgeons today are not required to exhibit creden-tials in the use of electrosurgery. Until universal educa-tional standards are developed and adopted, ongoing participation in training and educational seminars, cou-pled with use of prevention techniques like active elec-trode monitoring may help to significantly reduce patient injury and thereby minimize surgeons' and hos-pitals' risk of litigation.