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2. Exceptions (all have strict criteria to meet)a. Physician services in group practice of

referring physicianb. In-office ancillary servicesc. Services of prepaid plansd. Ownership investments in large publicly

traded companiese. Services at Puerto Rican hospitalsf. Services at rural providers

g. Ownership of hospital (but notsubdivisions)

h. Rental of space or equipmenti. Bona fide employment relationshipj. Personal service agreements----compensa­

tion unrelated to business generatedbetween parties

k. Certain physician incentive plans1. Remuneration unrelated to deSignated

health servicesm. Physician recruitmentn. Isolated transactionso. Certain group practice agreements with

hospitalsp. Physician payments for certain items or

services3. Enforcement

a. Regulations promulgated only on StarkI (laboratories)

b. Government is not enforcing Stark IIwhen interpretation is still needed.

c. When final regulations are made, a majoreffort to enforce is expected.

d. Will apply retroactively to effective dateof the law (l January 1992 for laboratoryservices and 7 January 1995 for others).

B. Advice1. Ensure that all financial relationships meet

criteria.2. Avoid agreements with referral entities that

sound too good, even if they may meetcriteria.

3. Meeting Stark II exceptions do not grantexemption from antikickback rules.

V. Other Ongoing Investigational AreasA. Upcoding/miscoding

1. Previously thought to be defensible asmaximiZing reimbursementa. Be aware of companies that work on

percentage of recoveries.i) Even errors made unwittingly can

cause aggressive criminalinvestigation.

ii) Government position is known orshould have been known.

B. Kickbacks1. Joint ventures and other seemingly

appropriate business arrangements that aremere shams to pay for referrals

2. Payments to consultants or payments forlegitimate services in excess of fair value

VI. Qui Tam Actions (Whistle Blower)A. Large increase in number

1. Usually charges made by disgruntledex-employees

2. Individual ("relator") who has evidence offalse claims brings action under seal ingovernment's namea. If government takes case, the qui tam

relator sits back and awaits verdict orsettlement and receives percentage ofsettlement (large dollar amount).

b. If government declines, the qui tamrelator can still proceed with case at hisor her own cost and still receivespercentage of any recovery.

B. Government allowed to investigate beforetaking case and before disclosure to defendant

VII. If InvestigatedA. Consult with qualified counsel immediately on

suspicion or threat of investigationB. Notify key employees of impending inquiry

and procedures to follow if an agent shouldcontact them (counsel can provide outline).

C. If agent appears at workplace, generally1. Check identification.2. Do not answer questions.3. Keep agents away from employees.4. Subpoena versus search warrant5. Identify and copy records given.

D. Avoid investigations-Know what is going onand have an active compliance program.

Plenary Session-Gastrointestinal InterventionModerator: Frederick S. Keller, MD

10:15 am

Gastrostomy: Establishing and Maintaininga Practice

M. Victoria Marx, MD

Learning objectives: As a result of attending the ple­nary session, the attendee will be able to: (1) identify atleast five potential referralpopulations for percutaneousgastrostomy tube placement; (2) identify four key pointsabout the preprocedure patientpreparation; (3) identifyfour relative contraindications to gastrostomy or gastro­jejunostomy (Cf) tube placement; (4) identify the prosand cons ofsuture anchor use; and (5) identify the keycomponents of immediate postprocedure care.

PERCUTANEOUS fluoroscopic gastrostomy (PFG) andpercutaneous endoscopic gastrostomy (PEG) were firstdescribed in 1980. Since that time, percutaneous (ratherthan surgical) placement of gastrostomy tubes has be­come standard in most hospitals. However, endoscopicgastrostomy by surgeons or gastroenterologists is more

commonly performed than fluoroscopic gastrostomy byinterventional radiologists. The goal of this presentationis to outline basic principles that can be used by inter­ventional radiologists to establish and maintain a gas­trostomy tube practice.

Establishing a Referral BaseSurgeons and gastroenterologists skilled in interven­tional endoscopic techniques will not refer patients tointerventional radiologists for fluoroscopic gastrostomytubes except in unusual circumstances-an upper gas­trointestinal mass that precludes endoscopy, a patientthat is at extremely high sedation or aspiration risk, or aPEG attempt that failed. Because these events do hap­pen, it is important that the interventional radiologistsinform endoscopy colleagues that the fluoroscopic pro­cedure is an available option.

Other physicians will refer directly to interventionalradiologists for percutaneous feeding tube placement ifthey are aware of the option, especially for patients whoare unlikely to have underlying gastrointestinal diseasethat needs endoscopic evaluation. Referral sources caninclude generalists who provide care to nursing homes;geriatric specialists; gynecological oncologists; and ear,nose, and throat surgeons, as well as both adult andpediatric neurosurgeons, neurologists, phYSical medi­cine and rehabilitation physiCians, pulmonologists whocare for cystic fibrosis patients, and oncologists. Inter­ventionalists should contact potential referral sources di­rectly and provide them with information about PFG/G].These groups of physicians are frequently unaware ofPFG/GJ until approached by an interventional radiolo­gist and are receptive to this option for long-term feedingaccess.

Developing a PracticeThe keys to developing a gastrostomy tube practice areto provide prompt service, thorough follow-up and(most important) to avoid acute complications in the firstfew patients. Avoidance of complications requires thatthe patient be properly prepared, that the procedure bedone qUickly and with as few catheter exchanges aspossible, and that postprocedure instructions to both in­hospital and posthospital care givers be clear and com­plete. Mishandling of a new tube can be an unfortunatecause of avoidable complications. If possible, it is opti­mal to avoid procedures that are likely to be technicallydifficult or complex early in one's practice (see relativecontraindications below).

Indications and ContraindicationsThe major indication for PFG is inability to eat becauseof central nervous system disease, peripheral neurologicor neuromuscular disease, or obstructing cancer of thepharynx or esophagus. Another indication is inadequateoral nutritional intake because of the general malaiseassociated with cancer, swallowing dysfunction, or cys­tic fibrosis. Gastrostomy tubes are also occasionallyplaced for drainage to palliate gastric outlet or small

bowel obstruction. The indications for transpyloric feed­ing and gastrojejunostomy tube placement are gastro­esophageal reflux with or without aspiration, obtunda­tion, gastric outlet obstruction, and significant delay ingastric emptying. A dual lumen gastrojejunostomy tubeis necessary if gastric drainage or venting is needed or ifthe patient is on medication that must be administeredinto the stomach or that is not available in liquid form.

Uncorrectable coagulopathy should be considered anabsolute contraindication to PFG/GJ because these arenot emergency procedures. Relative contraindicationsinclude gastric malignancy, portal hypertension withgastric varices or portal gastropathy, previous partial gas­tric resection, ascites, presence of a ventriculoperitonealshunt less than 1 month old, presence of a Laveen shunt,ongoing peritoneal dialysis, general combativeness, on­going infection, and fever of unknown etiology.

Patient PreparationThe most important part of preparing the patient for PFGis to decide what type of tube to place: gastrostomy,single lumen gastrojejunostomy, or dual lumen gastroje­junostomy. The right tube serves the patient needs anddemands as little care as possible. Gastrostomy tubes arethe simplest to care for and dual lumen gastrojejunos­tomy tubes are the most complex. The decision of typeshould be based on thorough knowledge of patient'smedical history, gastrointestinal surgical history, medica­tions, mental status, and living situation. When historicalinformation about gastrointestinal anatomy and/or func­tion is limited or equivocal, investigative studies shouldbe performed. These can include a swallowing study,upper gastrointestinal series, pH probe, and/or gastricradioisotope scan.

Preprocedure lab tests should include hematocrit (asa baseline if postprocedure hemorrhage occurs), leuko­cytes, platelets, prothrombin time, and partial thrombo­plastin time. The criteria for proceeding with tube place­ment are: normal leukocyte count (or leukocyte leuko­cyte >1000 in immunosuppressed patients); plateletcount >50,000; international normalized ratio <1.3, andpartial thromboplastin time normal. Note that mild co­agulopathy caused by vitamin K deficiency is common inpoorly nourished patients; it is correctable with vitaminK administration.

Percutaneous fluoroscopic gastrostomy can be per­formed as a "same day admission" or 23-hour admission,although most referrals are hospital inpatients. Prepro­cedure orders should stipulate that the patient havenothing by mouth or by nasoenteric feeding tube exceptmedications with sips of water for a minimum of 6 hoursbefore the procedure. A nasogastric tube and peripheralintravenous tube should be placed. A single dose ofbroad spectrum antibiotic for infection prophylaxis iscontroversial, but 1 have found it to be associated with adecreased occurrence of fever in the first 24 hours aftertube placement.

The consent process may be complex and shouldinclude discussion of immediate risks and long-term is-

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134

sues with the patient (when possible), the legal guard­ian, and the primary care giver(s). Acute complicationsinclude technical failure because of interposition of thecolon between the stomach and abdominal wall (2%),hemorrhage that possibly requires transfusion or endos­copy (2%), peritonitis that requires prolongation of hos­pitalization and intravenous antibiotics (3%), and perito­nitis that requires emergency surgery «1%). (Note thatthe percentages listed above reflect the University ofMichigan experience for the past 6 years). Chronic peri­catheter leak can occur in patients with peritoneal fluid.

Patients and families should be told to expect someabdominal and subdiaphragmatic pain for 24 to 48hours. They must also be informed that it can take up to6 weeks to settle into a feeding schedule; that gastros­tomy and gastrojejunostomy tubes require daily care;and that despite good care, the tubes can malfunction,break, clog, and come out. They need to to learn torecognize these events and learn what to do about them(see follow-up, below).

Technical Aspects of the ProcedureThe technical aspects of PFG/GJ tube placement are welldescribed in the literature and techniques are fairly uni­form. A few of the following points are, however, worthemphasizing.

A stomach that lies high above the costal margin(such as in patients who have severe kyphoscoliosis)may become accessible after administration of intrave­nous glucagon and insufflation of the stomach with air.Intercostal tube placement should be avoided becausethe anterior ribs are so close together that the tubes areextremely uncomfortable.

Transhepatic tube placement has been described.The gastric fundus should be aspirated dry via the

nasogastric tube before gastric puncture to minimize thevolume of any gastric secretion leak during the proce­dure.

Abdominal wall scarring and peritoneal adhesionscan greatly increase the difficulty of tract dilation­particularly for large dual lumen tubes.

Placement of one or two suture anchors aids in tractdilatation by allowing counter traction on the musculargastric wall as the dilators are advanced and by stabiliz­ing the stomach during negotiation of the pylorus andduodenal sweep. Gentle traction on the suture anchorsalso heips to minimize air leak into the peritoneal cavityduring catheter exchanges-which minimizes postpro­cedure pain.

The benefit of leaving in suture anchors for 7 to 10days after tube placement is questionable. The troublewith leaving them in is that it is easy to forget to removethem-retained suture anchors can lead to painful localinfection and can be difficult to remove.

Working through a stiff sheath that can be torqued tothe patient's right can aid in cases where catheterizationof the pylorus is difficult.

If access to the stomach is lost, an immediate attemptto reaccess the stomach should be performed and a gas-

trostomy tube should be placed. The patient should becontinued on intravenous antibiotics and intestinal restfor at least 48 hours.

Postprocedure CareThe goals of the postprocedure care protocol are to ob­serve the patient for evidence of hemorrhage and infec­tion, minimize risk of gastric distention and peritonealleak, and allow early initiation of tube feeding with asshort a hospital stay as possible. Do not routinely leavein a nasogastric tube but do leave the stomach at rest for24 hours except for medications. Initiate jejunal feeds theday of tube placement and gastric feeds 24 hours later.The average length of stay for persons admitted to thehospital specifically for tube placement is 48 to 72 hours.Shorter length of stay is possible if adequate patient andcaregiver teaching has been accomplished before tubeplacement and if the patient lives within a reasonabledistance of the hospital.

Long-Term Follow-UpWritten instructions to send home with the patient areinvaluable. The instructions should address dressingchanges, bathing, activity restrictions, flushing instruc­tions, medication administration instructions, and whatto do/where to call if the tube plugs up, breaks, or fallsout. We have found it to be extremely beneficial to havea point person (a nurse) on the interventional team totriage gastrostomy tube-related phone calls.

Prophylactic tube changes should be performed on ascheduled basis to decrease the need for emergency vis­its to the interventional radiologist. Gastrostomy tubesshould be changed at 6 to 9 month intervals whereasgastrojejunostomy tubes should be changed at 3 to 6month intervals. Conversion of a standard Cope looptype of gastrostomy tube to one with a retention balloonalloW's subsequent changes to be performed at horne.

Many patients are candidates for conversion to gas­trostomy button after the tube tract is mature. Threemonths is standard. Gastric and transgastric jejunal but­tons are available. The buttons are sturdy, cosmeticallysuperior to tubes, and less likely to to get inadvertentlyremoved. Those that have a retention balloon can bechanged at home. Buttons should be changed at leastonce a year or when they malfunction.

Selected BibliographyBell Sd, Carmody EA, Yeung EY, et al. Percutaneous

gastrostomy and gastrojejunostomy: additional ex­perience in 519 procedures. Radiology 1995; 194:817-820.

Halkier BK, Ho CS, Yee ACN. Percutaneous feedinggastrostomy with the Seldinger technique: review of

252 patients. Radiology 1989; 171:359-362.Hicks ME, Surratt RS, Picus D, et al. Fluoroscopically

guided percutaneous gastrostomy and gastroenter­ostomy: analysis of 158 consecutive cases. AJR 1990;154:725-728.

Ho CS, Yee ACN, McPherson R. Complications of sur-

gical and percutaneous nonendoscopic gastros­tomy: review of 233 patients. Gastroenterology

1988; 95:1206-1210.O'Keeffe F, Carrasco CH, Charnsangavej C, et al. Per­

cutaneous drainage and feeding gastrostomies in

100 patients. Radiology 1989; 172:341-343.

Marx MY, Williams DM, Perkins A], Reynolds PI, NelsonVS, Andrews ]C, et al. Percutaneous feeding tubeplacement in pediatric patients: immediate and 30­day results. ]VIR 1996; 7:107-116.

10:35 am

Medicare UpdateTerrence L. Kay

10:55 am

Esophageal Cancer and Stents

Robert E. Barton, MD

Learning objectives: As a result of attending this ses­sion, the attendee will be able to: (1) list treatment op­tions for patents with esophageal cancer; (2) identifypatients appropriatefor stentplacement; and (3) list an­ticipated outcomes and complications following stentplacement.

APPROXIMATELY 100,000 new cases of esophageal can­cer are diagnosed annually. Squamous cell carcinomaaccounts for the majority of cases of primary esophagealmalignancy. It occurs most often in the proximal andmiddle esophagus. Adenocarcinoma is the second mostcommon tumor type and is usually found around thegastroesophageal junction. The esophagus may also beinvolved by direct extension of lung cancer or by medi­astinal metastases.

Progressive dysphagia is the usual presenting symp­tom. Unfortunately, most patients have advanced dis­ease when diagnosed. Only 40% are candidates for sur­gical resection and few of these will be cured. The I-yearand 5-year survival rates for those with primary esoph­ageal cancer are 18% and 5%, respectively. Approxi­mately 5%-10% of patients, particularly those with squa­mous cell carcinoma or lung cancer invading the medi­astinum, will also develop esophagorespiratory fistulae.These patients have severe aspiration and usually sur­vive less than a month.

In the majority of patients, therefore, the goal oftherapy is palliation. For most, this means relieving dys­phagia by relieving esophageal obstruction. Over theyears, a variety of treatments have been employed withmixed results. Chemotherapy and radiation therapy,used together or separately, have had limited successand often these modalities provide no relief. When im­provement does occur, it may take weeks and is oftentransient. Palliative bypass surgery is rarely used becauseof its high morbidity and mortality. In recent years, en­doscopic therapy has become commonplace. Obstruc­tion is relieved by debulking tumors using injection ofsclerosants, cryotherapy, photocoagulation, and laser. A

major drawback to all of these modalities is the need formultiple treatment sessions, often at high cost. None ofthese treatments are beneficial in those with esophago­respiratory fistulae.

An alternative to these methods that promises moredurable results is to relieve obstruction by stent place­ment. Rigid plastic endoprostheses have been used foryears with limited success. The rigidity, large outer di­ameter, and small inner diameter causes numerous prob­lems. Insertion of these devices is often traumatic andesophageal perforation is common. They are prone tomigrate and cause pressure necrosis and bleeding. Be­cause of a small inner diameter, they are also prone tobecome obstructed by food. Overall complication ratesassociated with the use of these devices ranges from 15%to 40%.

The recent development of large-diameter, self­expanding stents has significantly altered the manage­ment of unresectable esophageal carcinoma. These canbe placed easily on an outpatient basis and provide ex­cellent symptomatic relief in more than 90% of patients.In addition, use is associated with lower complicationrates than were obtained using rigid endoprostheses.The goal of palliative therapy in terminally ill patientsshould be to provide permanent symptomatic relief withlittle morbidity and at a reasonable cost. Expandable me­tallic stents have done much to realize this goal.

StentsA number of self-expanding stents have been used suc­cessfully to treat esophageal malignancy. Six esophagealstents are commercially available today in the UnitedStates. All were approved within the last 2 years. Theyvary considerably in properties and delivery systems.Four of the stents are covered with a nonpermeablemembrane and two are uncovered. All can be used totreat esophageal obstruction, but only the covered stentsare suitable for use in patients with esophagorespiratoryfistulae.

The Cook Esophageal Z-stent (Cook Inc., Blooming­ton, Ind) consists of 5-7 interconnected 2-cm-Iong Z­stent bodies covered with a polyethylene membrane.This stent has an inner diameter of 18 mm along theshaft. The stent bodies on either end of the stent areflared to 25 mm. Four metal barbs are attached to themiddle of the stent to prevent migration. This stent hasgood expansile force and does not shorten when de­ployed.

A similar stent is available from Wilson-Cook Medical,Inc. (Winston-Salem, NC). This stent differs from theCook stent in that it lacks barbs and has a smaller flare.It also comes with a significantly different delivery sys­tem that is designed for endoscopic stent placement.

The Wallstent Esophageal Prosthesis (Schneider Inc.,Minneapolis, Minn) is a covered stent consisting of aproprietary polymer membrane sandwiched betweentwo large diameter Wallstents. This stent has a diameterof 18 mm along the shaft and 28 mm at either end. It

comes in deployed lengths of 80, 100, and 130 mm and135