Introduction: The propagation of prostate cryosurgery has met with significant difficulty. This has been due to inadequate training of new physicians leading to complications (and variable results), poor reimbursement, expensive capital equipment and rapidly changing technology. The authors will describe a healthcare delivery system in which a full services cryosurgery program is offered to physicians inexperienced in cryosurgery.
Methods-The program consists of a central entity providing:
1) Initial cryosurgery training through workshops, with continued training provided by an experienced
cryosurgeon/proctor at every case.
2) Latest cryosurgical equipment on a per case mobile basis.
3) Negotiations for the physician, facility and patient for reimbursement.
4) Experienced back-up for possible complications.
Patients with T 1 through T3 disease was included in this program, Selected patients underwent partial freezing for a nerve sparing cryoprostatectomy. All patients except those already treated with CHT had staging biopsies. The procedure protocol included temperature monitoring in appropriate locations, 2-3 freeze-thaw cycles, use of 5-8 cryoprobes in an Argon gas system, saline injected into Denonvillier's Fascia prior to freezing, freezing until fixation of the urethral warmer, prophylactic freezing of the confluence of seminal vesicles and post procedure Foley catheterization for three weeks. Follow-up PSA's were obtained at 3 month intervals for the first year and 6 month intervals thereafter. Patients with post operative PSA's that were greater than .2 or unstable PSA's evidenced by PSA elevation of .2 on successive determinations were biopsied.
Results- The above entity, Advanced Medical Procedures (AMP) has been carrying out cryosurgical procedures for approximately 3 years. Sixty-two patients have been treated through the system by 12 different urologists. Reimbursement from third party payers for cryosurgical procedures was successfully obtained in 95% of cases in which clearance was attempted. Reimbursement was successfully obtained from 25 different insurance carriers. Reimbursement was also successfully obtained from Medicare HMO's, secondary insurers of Medicare patients, and Blue Cross-Blue Shield. Ten Medicare patients paid for the procedure themselves and all who have completed the appeals process have been successfully reimbursed.
The patient population treated who had a poor prognosis based on Gleason grade 7 or greater, PSA 10 or above, or previously failed radiation constituted forty-two of sixty-two patients (68%).
Fifty-eight of sixty-two patients have stable PSA's (94%). Fifty-two of sixty-two patients have stable PSA's of .2 or less (84%), however, four of ten patients with PSA's above .2 had partial freezing for nerve sparing. The four patients with unstable PSA's comprise two radiation failures, one stage T3 patient with a preoperative PSA of 43, and one nerve sparing cryo (with a post op PSA of .4). Of thirtyone patients biopsied 31 of 31 (100%) have negative biopsies.
The median PSA for non-radiation patients was 1, .1, .12 and 0, for patients with <1 yr., I yr., 2 yr., and 3yr. Follow up respectively.
The median PSA for radiation failure patients was .0, .12,.4, . 1, for patients with <I yr., I yr., 2 yr., and 3 yr. Follow up respectively.
The post treatment mean PSA value for all 62 patients was .25 and the median was . 1.
There was no statistical difference between post treatment PSA values based on time of follow-up or between radiation and non-radiation failure patients.
No serious complications such as urethrorectal fistula have occurred. Forty-three of forty-three patients (100%) with no previous radiation or prostate surgery, were fully continent. Patients with previous radiation however were continent only 66% of the time.
Conclusion- Cryosurgery can be successfully propagated with excellent results, minimal morbidity, and good reimbursement through a dedicated cryosurgery services company. This model could be useful in introducing any new surgical procedure with high capital equipment costs and a significant learning curve.