Why We Reversed Our Position After 15000 Parathyroid Operations

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Why We Reversed Our Position After 15000 Parathyroid Operations ORIGINAL SCIENTIFIC ARTICLES Abandoning Unilateral Parathyroidectomy: Why We Reversed Our Position after 15,000 Parathyroid Operations James Norman, MD, FACS, FACE, Jose Lopez, MD, FACS, Douglas Politz, MD, FACS, FACE BACKGROUND: Our group championed the techniques and benefits of unilateral parathyroidectomy. As our experience has matured, it seems this limited operation might be appropriate only occasionally. METHODS: A single surgical group’s experience with 15,000 parathyroidectomies examined the ongoing differences between unilateral and bilateral techniques for 10-year failure/recurrence, multig- land removal, operative times, and length of stay. RESULTS: With limited experience, 100% of operations were bilateral, decreasing to 32% by the 500th operation (p Ͻ 0.001), and long-term failure rates increased to 6%. Failures were 11 times more likely for unilateral explorations (p Ͻ 0.001 vs bilateral), causing gradual increases in bilateral explorations to 97% at the 14,000th operation (p Ͻ 0.001). Ten-year cure rates are unchanged for bilateral operations, and unilateral operations show continued slow recurrence rates of 5% (p Ͻ 0.001). Removal of more than one gland occurred 16 times more frequently when 4 glands were analyzed (p Ͻ 0.001), increasing cure rates to the current 99.4% (p Ͻ 0.001). Of 1,060 reoperations performed for failure at another institution, intraoperative parathyroid hormone levels fell Ͼ50% in 22% of patients, yet a second adenoma was subsequently found. Operative times decreased with experience; bilateral operations taking only 5.9 minutes longer on average (22.3 vs 16.4 minutes; p Ͻ 0.001), which is 25 minutes less than unilateral at the 500th operation (p Ͻ 0.001). By the 1,000th operation, incision size (2.5 Ϯ 0.2 cm), anesthesia, and hospital stay (1.6 hours) were identical for unilateral and bilateral procedures. CONCLUSIONS: Regardless of surgical adjuncts (scanning, intraoperative parathyroid hormone), unilateral para- thyroidectomy will carry a 1-year failure rate of 3% to 5% and a 10-year recurrence rate of 4% to 6%. Allowing rapid analysis of all 4 glands through the same 1-inch incision has caused us to all but abandon unilateral parathyroidectomy. (J Am Coll Surg 2012;214:260–269. © 2012 by the American College of Surgeons) Primary hyperparathyroidism (pHPT) is a benign disease these small parathyroid tumors typically cause chronic fa- with malignant potential. Untreated, it is believed to carry tigue, memory loss, and a host of other nonspecific symp- a near 2-fold increase in development of several cancers (eg, toms associated with a considerable decrease in quality of breast, colon, prostate),1,2 and increases the risk of cardiac life.4,5 disease, hypertension, and stroke by more than double, Fortunately, pHPT is curable with removal of the source ultimately carrying a several-year decrease in life expec- of excess parathyroid hormone (PTH). In about 76% of tancy.3 Substantial if not severe osteoporosis will almost patients, the source is a single benign parathyroid tumor, always develop in affected patients, and 25% will get kid- and in the other 24% or so, there are 2, 3, or even 4 ney stones. Besides the damage to many organ systems, overproducing glands that need to be removed—all or in part.4 Because the number and location of the overproduc- ing glands are variable and usually not known before oper- Disclosure Information: Nothing to disclose. Presented at the American College of Surgeons 97th Annual Clinical Con- ation, the surgical techniques for removing these parathy- gress, San Francisco, CA, October 2011. roid tumors have historically included evaluation of all 4 Received October 24, 2011; Revised December 12, 2011; Accepted Decem- parathyroid glands to determine which of the glands needs ber 14, 2011. to be removed. As such, parathyroidectomy has necessi- From the Norman Parathyroid Center, Tampa, FL. tated general endotracheal anesthesia and bilateral explora- Correspondence address: James Norman, MD, FACS, FACE, Norman Para- thyroid Center, 2400 Cypress Glen Dr, Wesley Chapel, FL 33544. email: tion; an operation that typically includes a generous neck [email protected] incision and several hours of operating time. © 2012 by the American College of Surgeons ISSN 1072-7515/12/$36.00 Published by Elsevier Inc. 260 doi:10.1016/j.jamcollsurg.2011.12.007 Vol. 214, No. 3, March 2012 Norman et al Abandoning Unilateral Parathyroidectomy 261 be opened to remove another tumor. In retrospect, these Abbreviations and Acronyms tumors were present at the first operation, but were smaller IOPTH ϭ intraoperative parathyroid hormone and producing less PTH, so removal of the large parathy- pHPT ϭ primary hyperparathyroidism roid tumor gave the appearance that the patient was cured. PTH ϭ parathyroid hormone These patients did not have recurrent disease; they were never completely cured at their first operation. These pa- tients had persistent disease, it just was not completely With the advent of the sestamibi scan in the early 1990s apparent for some months or years after the operation. came the concept that a surgeon could know with high It slowly become obvious within our practice that the certainty which patients harbored a single bad gland and its only way to achieve a near 100% long-term cure rate was to location. Armed with a localizing study, the operation evaluate the physiologic activity of all 4 parathyroid glands could be conducted with a unilateral approach, allowing in virtually all people at their first operation. As such, we for a quicker, smaller operation. Our group was a principal gradually gave up on unilateral parathyroidectomy in al- advocate for the unilateral approach, publishing numerous most every instance by the end of 2006. This study outlines articles between 1994 and 2005 touting the benefits of, the progression of this concept and the long-term results of and techniques used in, unilateral minimally invasive unilateral vs bilateral parathyroidectomy in 15,000 pa- parathyroidectomy.6-17 We published studies showing that tients. Lessons learned here have important implications the vast majority of patients were best served by a unilateral for all surgeons performing parathyroidectomy, regardless operation if they had a localizing study showing a single of their level of expertise. gland, provided that some form of physiologic measure of hormone production was performed in the operating room METHODS to help assure that the source of the excess PTH had been removed. This method of unilateral operation has now be- Study design come common throughout the world, with expected cure A retrospective analysis was conducted of prospectively col- rates in the low to mid-90% range, depending on surgeon lected data on 15,060 consecutive patients undergoing experience.18-21 parathyroidectomy by one surgical group during an 18- By 2005, volume of our practice had grown to Ͼ1,000 year period ending April 2011. All patients had primary parathyroid operations annually. With this volume came hyperparathyroidism; patients with secondary (renal) or the requirement of higher and higher cure rates, as a 3% to tertiary (post-transplantation) hyperparathyroidism are 6% long-term failure rate causes considerably greater not included. All patients were selected for surgery based follow-up and management problems with such high sur- on the biochemical diagnosis of pHPT as outlined in detail gical volumes. By 2010, our volume had exceeded 2,000 by our group recently.4 Preoperative scanning was never used parathyroidectomies per year, necessitating the very highest as a determinant of surgery vs no surgery. As outlined here, we cure rates available. A confounding issue for our practice do not perform any scan before the morning of surgery. was that many patients travel long distances to our center. Other patients not included in this study were those who A noncured patient who lives 3,000 miles away has differ- had undescended parathyroid tumors necessitating a ent implications for our practice than that noncured pa- nonstandard neck incision high in the neck and those with tient who lives within our community. Another confound- mediastinal tumors necessitating some form of thoracot- ing issue for our practice was the gradual but considerable omy, because evaluation of all 4 parathyroid glands is not increase in referrals of patients with negative scans who possible during these operations. All patients signed a con- were not being afforded surgery by surgeons in their com- sent for review of their clinical data, which was collected in munity because they could not localize an adenoma preop- a nonidentifiable fashion in accordance with principles eratively. As our surgical volume increased, so too did the outlined in the Declaration of Helsinki and as required for percentage of complex and/or scan-negative patients. our IRB approval. During the course of performing thousands of parathy- roidectomies, it became clear that there was no maneuver Patient groups we could perform preoperatively or intraoperatively that For purposes of comparisons, the 15,060 patients have would assure us that all abnormal parathyroid tissue had been divided into 2 groups: group 1 consists of 14,000 been removed—short of the direct evaluation of the other patients undergoing their first parathyroid operation glands. Patients who we were convinced were cured some (which was performed by the authors). This group was years earlier were showing up again with abnormal calcium used to establish short and
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