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Elizabeth A Mittendorf

Publications and source records attributed to Elizabeth A Mittendorf.

At least 19 recordsLinked to original sources
PubMed2026

Association of immune and proliferation gene signatures and stromal tumor-infiltrating lymphocytes with clinical outcomes in patients with stage I triple-negative breast cancer.

BACKGROUND: One-third of patients with triple-negative breast cancer (TNBC) are diagnosed with stage I tumors. Biomarkers to stratify prognosis in this setting remain a major unmet need. METHODS: Tissue samples and clinicopathologic data were retrieved from consecutive patients with stage I TNBC (defined as ER <10% and HER2-negative) who underwent upfront breast surgery and received standard of care adjuvant systemic therapy at Dana-Farber/Brigham Cancer Center between 2016 and 2021. The TNBC-DX assay (Core Immune Gene [CIG] signature, proliferation signature) was applied to tumor tissue, and stromal tumor-infiltrating lymphocytes (sTILs) were centrally reviewed. Both biomarkers were tested for association with clinical outcomes using the Kaplan-Meier method. RESULTS: A total of 253 patients with stage I TNBC were included. Most tumors were ductal (88.9%) and high-grade (73.1%); 65.2% of patients received adjuvant chemotherapy. With 18 recurrence events observed, the 3-year recurrence-free survival (RFS) in the overall cohort was 95.0% (95% confidence interval [CI]: 92.1% - 98.1%) and the 3-year overall survival was 97.9% (95% CI: 95.9% - 100.0%). No significant differences in RFS were observed by TNBC-DX (n&#x202f;=&#x202f;117 patients) or sTILs (n&#x202f;=&#x202f;123 patients) category. However, a 3-year RFS of 100% (95% CI: 100% - 100%) was observed among the 29 patients with the highest CIG score quartile. A favorable prognosis was also observed in patients with high sTILs (>20%), who experienced a 3-year RFS of 97.0% (95% CI: 90% - 100%). Conversely, a high TNBC-DX proliferation score was numerically associated with poor outcomes, with a 3-year RFS of 83% (95% CI: 68% - 100%). CONCLUSIONS: In this retrospective study, immune and proliferative features showed opposing prognostic trends in stage I TNBC. Their integration may improve risk stratification and warrants further investigation.

Stromal tumor infiltrating lymphocytes (sTILs)↗
PubMed2026

Neoadjuvant Paclitaxel, Trastuzumab, and Pertuzumab for Stage II to III, ERBB2-Positive Breast Cancer: A Secondary Analysis of the DAPHNe Trial.

IMPORTANCE: The neoadjuvant combination of paclitaxel, trastuzumab, and pertuzumab (THP) represents a promising abbreviated regimen for early-stage ERBB2-positive breast cancer, but long-term outcomes and the role of ultrasensitive circulating tumor DNA (ctDNA) monitoring remain incompletely defined. OBJECTIVE: To assess 5-year outcomes and characterize ctDNA dynamics with an ultrasensitive assay in patients with ERBB2-positive breast cancer receiving neoadjuvant THP. DESIGN, SETTING, AND PARTICIPANTS: This study was a prespecified secondary analysis of the prospective, single-arm, investigator-initiated phase 2 DAPHNe nonrandomized clinical trial. Patients were enrolled in the DAPHNe trial from November 2018 to January 2020. The trial took place at a multicenter academic cancer center and affiliated community practices. Participants included patients with stage II to III ERBB2-positive breast cancer receiving neoadjuvant THP for 12 weeks. Ultrasensitive ctDNA analyses were performed in patients with available tumor tissue and serial plasma samples. The secondary analysis was conducted between between March 2023 and April 2025. INTERVENTIONS: Neoadjuvant THP administered for 12 weeks, followed by surgery and adjuvant therapy guided by pathologic response. MAIN OUTCOMES AND MEASURES: Main outcomes included 5-year event-free survival, recurrence-free interval (RFI), distant RFI, and overall survival. ctDNA detection and clearance were assessed using a whole-genome-based, tumor-informed ultrasensitive assay at 4 predefined time points (baseline, preoperative, postoperative, and late adjuvant). RESULTS: The overall trial cohort included 98 patients (median [IQR] age, 49.5 years [24.0-78.0 years]; 97 female patients [99.0%]; 1 male patient [1.0%]), with mostly stage 2 disease (91 patients [92.9%]) and hormone receptor-positive tumors (65 patients [66.3%]). With a median (IQR) follow-up of 5.2 (5.0-5.4) years, the 5-year event-free survival was 99% (95% CI, 97%-100%), the 5-year RFI was 98% (95% CI, 93%-100%), the 5-year distant RFI was 100% (95% CI, 100%-100%), and the 5-year overall survival was 99% (95% CI, 97%-100%). Among 57 patients included in ctDNA analyses, baseline ctDNA was detected in 51 individuals (89.5%). After neoadjuvant therapy, ctDNA clearance occurred in 49 of 51 patients (96.1%), with only 2 individuals (3.9%) remaining ctDNA-positive preoperatively; detectability remained low (<10%) during postoperative follow-up. One single patient experienced a local recurrence, with ctDNA detected at time of recurrence and cleared following surgical resection. CONCLUSIONS AND RELEVANCE: In this secondary analysis of the DAPHNe nonrandomized clinical trial, neoadjuvant THP was associated with excellent long-term outcomes in patients with early-stage ERBB2-positive breast cancer. Ultrasensitive ctDNA analyses demonstrated high baseline detection rates and near-universal clearance after abbreviated neoadjuvant therapy, supporting further investigation of ctDNA-guided de-escalation strategies in this setting. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03716180.

Humans↗
PubMed2006

Investigating the combination of trastuzumab and HER2/neu peptide vaccines for the treatment of breast cancer.

BACKGROUND: Trastuzumab, an anti-HER2/neu monoclonal antibody, is thought to promote HER2/neu receptor internalization and/or turnover. This study was designed to investigate the kinetics of trastuzumab treatment on tumor cells with varying levels of HER2/neu expression and to determine the effect of trastuzumab on HER2/neu-specific cytotoxic T lymphocyte-mediated lysis. METHODS: Three cell lines with varying levels of HER2/neu expression were incubated with varying doses of trastuzumab at multiple time points. Trastuzumab binding and HER2/neu expression were determined. Peripheral blood mononuclear cells from three HLA-A2(+) healthy donors and four E75 peptide-vaccinated patients were stimulated with HER2/neu-derived peptides and tested in standard chromium release cytotoxicity assays with HER2/neu(+) tumor cells pretreated with trastuzumab. RESULTS: Treatment of tumor cells with 10 microg/mL of trastuzumab in an overnight incubation resulted in saturation of cell-surface HER2/neu receptors. At higher doses, trastuzumab staining and HER2/neu expression decreased in a time-dependent manner. Pretreatment of tumor cells with trastuzumab resulted in increases in specific cytotoxicity by peptide-stimulated cytotoxic T lymphocytes from HLA-A2(+) donors over untreated cells by an average of 5.6% and 15.3% (P = .0002) for doses of 10 and 50 microg/mL, respectively. In similar experiments involving peripheral blood mononuclear cells obtained from immunized patients, the average specific cytotoxicity for untreated cells was 34.2% +/- 1.3% vs. 40.6% +/- 2.5% (P = .035) and 40.7% +/- 1.6% (P = .0005) for those treated with 10 and 50 microg/mL, respectively. CONCLUSIONS: Our data suggest that pretreatment of breast cancer cells with trastuzumab induces turnover of the HER2/neu protein and enhanced killing by HER2/neu peptide-stimulated CTLs. This increased lysis occurs regardless of the degree of HER2/neu expression and seems more pronounced in vaccinated patients. These findings support further investigation into the use of combination immunotherapy with trastuzumab and HER2/neu peptide-based vaccines.

Antibodies, Monoclonal↗
PubMed2006

Evaluation of the HER2/neu-derived peptide GP2 for use in a peptide-based breast cancer vaccine trial.

BACKGROUND: E75 and GP2 are human leukocyte antigen (HLA)-A2-restricted immunogenic peptides derived from the HER2/neu protein. In a E75 peptide-based vaccine trial, preexisting immunity and epitope spreading to GP2 was detected. The purpose of this study was to further investigate GP2 for potential use in vaccination strategies. Importantly, a naturally occurring polymorphism (I-->V at position 2, 2VGP2) associated with increased breast cancer risk was addressed. METHODS: Prevaccination peripheral blood samples (PBMC) from HLA-A2 breast cancer patients and CD8+ T cells from HLA-A2 healthy donors were stimulated with autologous dendritic cells (DC) pulsed with GP2 and tested in standard cytotoxicity assays with HER2/neu+ tumor cells or GP2- or 2VGP2-loaded T2 targets. Additional cytotoxicity experiments used effectors stimulated with DC pulsed with E75, GP2, or the combination of E75+GP2. RESULTS: GP2-stimulated prevaccination PBMC from 28 patients demonstrated killing of MCF-7, SKOV3-A2, and the HLA-A2- control target SKOV3 of 28.8+/-3.7% (P<.01), 29.5+/-4.0% (P<.01), and 16.9+/-2.7%, respectively. When compared with E75, GP2-stimulated CD8+ T cells lysed HER2/neu+ targets at 43.8+/-5.2% versus 44.2+/-5.7% for E75 (P=.87). When combined, an additive effect was noted with 58.6+/-5.4% lysis (P=.05). GP2-stimulated CD8+ T cells specifically recognized both GP2-loaded (19.6+/-5.7%) and 2VGP2-loaded T2 targets (17.7+/-5.2%). CONCLUSIONS: GP2 is a clinically relevant HER2/neu-derived peptide with immunogenicity comparable to that of E75. Importantly, GP2-specific effectors recognize 2VGP2-expressing targets; therefore, a GP2 vaccine should be effective in patients carrying this polymorphism. GP2 may be most beneficial used in a multiepitope vaccine.

Breast Neoplasms↗
PubMed2006

When fine-needle aspiration biopsy cannot exclude papillary thyroid cancer: a therapeutic dilemma.

HYPOTHESIS: Clinical or cytologic factors predictive of malignancy can be identified and incorporated into a treatment algorithm for patients with a fine-needle aspiration biopsy (FNAB) specimen interpreted as "suspicious for" papillary thyroid cancer (PTC). DESIGN: Retrospective review of a prospectively maintained database. SETTING: University-affiliated tertiary care hospital. PATIENTS: Seven hundred thirty-eight patients with nodular thyroid disease evaluated between 1990 and 2004. INTERVENTIONS: Patients with an FNAB specimen suspicious for PTC were identified. The frequency of carcinoma was determined. Clinical features were reviewed. The FNAB specimens suspicious for PTC were examined in a blinded fashion to determine if specific cytologic features were important in distinguishing benign vs malignant disease. MAIN OUTCOME MEASURES: The presence of specific clinical and cytologic features was correlated with the incidence of carcinoma. A secondary outcome measure was to determine the value of frozen section examination in establishing the extent of thyroidectomy. RESULTS: Forty-five patients (7%) had an FNAB specimen suspicious for PTC; 18 (40%) of these patients had carcinoma. Prominent nuclear inclusions and/or grooves, papillary formations, and the absence of colloid were features associated with PTC (P<.05). No clinical features reliably identified malignant disease. Frozen section examination results altered treatment in 15 (56%) of 27 patients. CONCLUSIONS: An FNAB specimen suspicious for PTC is associated with a 40% incidence of carcinoma. Extensive nuclear inclusions and/or grooves, papillary formations, and the absence of colloid are predictive of carcinoma. Rare intranuclear inclusions and/or grooves alone in an otherwise benign-appearing specimen are uniformly associated with benign disease. Frozen section examination is of value in determining the extent of thyroidectomy.

Adenocarcinoma↗
PubMed2006

Vaccination with a HER2/neu peptide induces intra- and inter-antigenic epitope spreading in patients with early stage breast cancer.

BACKGROUND: We are conducting clinical vaccine trials with the HER2/neu peptide, E75, in patients with breast cancer. The purpose of this study was to demonstrate clonal expansion of E75-specific CD8(+) T cells and to identify intra- and interantigenic epitope spreading. METHOD: Pre- and postvaccination peripheral blood leukocyte samples (24 node positive [NP] and 20 node negative [NN]) from 44 vaccinated patients were analyzed. HLA-A2:Ig dimer molecules were loaded with the HER2 peptides, E75 or GP2, and were used with anti-TcR and CD8 antibodies to stain peripheral blood leukocyte immediately ex vivo and were analyzed with flow cytometry. In 8 randomly selected patients, dimers were loaded with the folate binding protein peptide E41 to evaluate for interantigenic epitope spreading. RESULTS: All patients with NP and 95% of the patients with NN showed E75-specific clonal expansion. Patients with NN showed more robust expansion. All patients with NP and 85% of the patients with NN showed evidence of intra-antigenic epitope that was spreading to GP2. However, patients with NN showed only moderate expansion to this subdominant epitope, which was not included in the immunizing mix. The degree of HER2/neu expression and disease stage impacted the ability to expand clonally E75- and GP2-specific CD8(+) T cells. Evidence of interantigenic epitope spreading to E41 was shown in 63% of the patients who were tested. CONCLUSION: Our data provide evidence for the induction of intra- and interantigenic epitope spreading that results from a single HER2/neu peptide vaccine even in early staged patients. The ability to raise immunity to multiple tumor antigens depends on both the degree of HER2/neu expression and the extent of disease. Epitope spreading is an essential element for the success of a peptide vaccine strategy.

Antigens, Neoplasm↗
PubMed2006

Islet cell tumors.

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Adrenocorticotropic Hormone↗
PubMed2005

Parathyroid carcinoma.

Parathyroid carcinoma is an uncommon malignancy. It accounts for less than 1% of cases of primary hyperparathyroidism (HPT). It is manifested by severe hypercalcemia and up to 50% of patients will have concomitant kidney or bone disease. The etiology of parathyroid carcinoma is unknown, however, the recently discovered HRPT2 gene, a tumor suppressor gene encoding for the protein parafibromin, has been implicated in the pathogenesis. Identification of inactivating germ-line mutations in HRPT2 has significant implications for diagnosis and management. This article summarizes the genetic aspects of parathyroid carcinoma, reviews its clinical manifestations, and outlines the principles of surgical therapy, the indications for adjuvant therapy, and the use of bisphosphonate and calcimimetic agents for management of hypercalcemia.

Carcinoma↗
PubMed2005

Evaluation of the CD107 cytotoxicity assay for the detection of cytolytic CD8+ cells recognizing HER2/neu vaccine peptides.

The recently reported FACS-based CD107 assay has been used in human HIV and CMV antigen models as well as in the ex vivo analysis of tumor cytolytic T cells in a melanoma model by a single group. The purpose of our study was to validate this assay and to use it in previously untested viral and tumor antigen models. Specifically, we investigated the use of the novel CD107 cytotoxicity assay in the detection of influenza and HER2/neu tumor-specific cytolytic CD8+ T cells. CD8+ T cells from HLA-A2+ healthy donors were stimulated with autologous dendritic cells pulsed with FluM or the HER2/neu peptides, E75 or GP2. These CD8+ T cells were then tested in cytotoxicity assays at varying effector:target (E:T) ratios against T2 targets. Cytotoxicity was measured by detection of CD107a and b on the surface of CD8+ T cells. An E:T of 1:5 was found to optimize the resulting percentage of CD8+CD107+ T cells. E75- and GP2-stimulated CD8+ T cells were then tested in cytotoxicity assays with MCF-7 (HER2/neu+HLA-A2+) and AU565 (HER2/neu+HLA-A2-) tumor cells. Cytotoxicity was measured by both the CD107 assay and the (51)Cr release assay. Results of cytotoxicity were then correlated between these two assays. In representative experiments, the CD107 assay identified average specific increases for E75- and GP2-stimulated cells of 4.26 and 3.57%, respectively. These results correlated favorably with cytotoxicity as measured by the traditional (51)Cr assay. These findings confirm preliminary reports of the CD107 assay and suggest its usefulness for monitoring cancer trials.

Antigens, CD↗
PubMed2004

Giant insulinoma: case report and review of the literature.

An insulinoma is a rare pancreatic endocrine tumor that is typically sporadic, solitary, and less than 2 cm in diameter. Fewer than 5% of insulinomas are larger than 3 cm. Ninety percent or more of all insulinomas are benign. Larger tumors are more likely to be malignant. We report a case of a giant pedunculated insulinoma, measuring 9 cm in diameter and weighing 100 g, with amyloid deposits accounting for 70% of the tumor volume. At the time of operation, no local invasion or metastatic disease was identified. On pathological evaluation, the tumor was classified as an insulinoma of uncertain biological behavior. In addition to describing the clinical presentation and operative findings, criteria for determining malignancy are outlined, a detailed pathological description is presented, and the 2000 World Health Organization Classification for Pancreatic Endocrine Neoplasms is reviewed.

Aged↗
PubMed2004

Post-parathyroidectomy hypocalcemia: incidence, risk factors, and management.

The purpose of this study was to evaluate the incidence and severity of hypocalcemia after parathyroidectomy and delineate its risk factors. Data was retrieved from a prospective database. Patients with postoperative hypocalcemia were identified and risk factors were investigated including primary versus renal hyperparathyroidism (HPT), preoperative calcium, parathyroid hormone (PTH) and alkaline phosphatase levels, gland weight, pathology, extent of surgery, and reoperative surgery. Of the 162 patients who underwent parathyroidectomy, 84 (52%) were hypocalcemic postoperatively: 55 (42%) of 132 patients with primary and 29 (97%) of 30 patients with renal HPT (P = 0.0001). Patients with renal HPT had more profound hypocalcemia with a mean +/- SD calcium of 7.34 mg/dL +/- 1.07 versus 7.76 mg/dL +/- 0.59 for patients with primary HPT (P < 0.05). Symptoms were present in 28 (51%) of 55 patients with primary and 13 (45%) of 29 patients with renal HPT. Only three (2%) patients with primary compared to 29 (97%) with renal HPT were treated with intravenous calcium. The average length of stay for hypocalcemic patients was 0.7 days for primary HPT versus 4.7 days for renal HPT (P < 0.0005). Patients with primary HPT who underwent subtotal parathyroidectomy had significantly lower postoperative calcium levels (7.95 mg/dL +/- 0.64) than patients who had a single or double adenoma removed (8.49 mg/dL +/- 0.79) (P = 0.036). No other factor was predictive of postoperative hypocalcemia. Patients with renal HPT develop profound postoperative hypocalcemia requiring intravenous calcium and vitamin D therapy. Hypocalcemia in patients with primary HPT develop less severe hypocalcemia that is amenable to outpatient oral calcium therapy and should be routinely initiated following subtotal parathyroidectomy.

Calcium↗
PubMed2004

Complications and sequelae of thyroidectomy and an analysis of surgeon experience and outcome.

Theodor Kocher is credited with refining the technique of thyroidectomy and reducing the incidence of postoperative hemorrhage. He also recognized the importance of preservation of the parathyroid glands. His accomplishments led to a reduction in surgical mortality, from 50% to less than 4.5%. Additional improvements in technique have reduced the mortality rate to near zero. Morbidity, however, remains a concern for surgeons who perform thyroid surgery. Complications and sequelae of thyroid surgery are reviewed, including recurrent and superior laryngeal nerve injury, temporary hypocalcemia, permanent hypoparathyroidism, thyroid storm, bleeding, wound infection, and hypothyroidism. The association between the volume of thyroidectomies performed by a surgeon and outcome is also discussed in this chapter.

Clinical Competence↗
PubMed2003

Utility of laparoscopy in chronic abdominal pain.

BACKGROUND: Patients with chronic abdominal pain can undergo numerous diagnostic tests with little change in their pain. This study was undertaken to assess the utility of performing diagnostic and therapeutic laparoscopy in patients with chronic abdominal pain for longer than 12 weeks. METHODS: All patients undergoing laparoscopy by the primary author were prospectively entered into a database for the 3-year period July 1, 1997 through June 30, 2000. The patients' demographic data, length of time with pain, number of diagnostic studies performed before surgery, intraoperative findings, interventions, pathology, and long-term follow-up were determined. RESULTS: A total of 70 patients (61 women and 9 men) with an average age of 42 years, underwent diagnostic laparoscopy only for the evaluation and treatment of chronic abdominal pain. The average length of time with pain was 74 weeks (range 12-260) and the average number of studies performed prior to surgical referral was 3.3. Fifty-three (76%) patients had their procedures performed as outpatients, with the remainder admitted for observation status. The average length of operative time was 70 minutes; no cases required conversion to an open procedure and no complications occurred. Findings included adhesions in 39, a hernia in 13, adhesions from the appendix to adjacent structures in 6, appendiceal pathology in 5, endometriosis in 3, and gallbladder pathology in 2. Ten patients had no obvious pathology. At the time of their initial postoperative visit, 90% reported their pain to be gone or improved. After an average follow-up of 129 weeks, 71.4% had long-term pain relief. All patients with recurrence of pain had it within the first 6 months. No patient experienced any long-term complications and all reported satisfaction with their procedure. CONCLUSIONS: Laparoscopy has a significant diagnostic and therapeutic role in patients with chronic pain. Therapeutic laparoscopy studies have to follow-up with patients at least 6 months. With aggressive indicated therapeutic laparoscopy, including adhesiolysis, appendectomy, cholecystectomy, or hernia repairs, more than 70% of patients can have improvement in their pain.

Abdominal Pain↗
PubMed2002

Persistent parathyroid hormone elevation following curative parathyroidectomy for primary hyperparathyroidism.

BACKGROUND: Persistent elevation of parathyroid hormone (PTH) levels following parathyroidectomy may indicate residual abnormal parathyroid tissue. OBJECTIVE: To determine the clinical significance and risk factors for persistent PTH elevation following curative parathyroidectomy. METHODS: A prospective study of consecutive patients with primary hyperparathyroidism who had resolution of hypercalcemia following parathyroidectomy. Patients with low or normal serum calcium and increased PTH levels postoperatively were identified, and serial calcium and PTH levels and clinical course were monitored. A multivariate analysis was performed to identify features associated with an elevated postoperative PTH level. RESULTS: Of 85 patients with resolution of hypercalcemia following parathyroidectomy, postoperative PTH levels were elevated in 23 (27%) (mean, 99 pg/mL; range, 70-194 pg/mL) and normal in 62 (mean, 30 pg/mL; range, 3-65 pg/mL) (P<.001). No significant differences in preoperative or postoperative calcium or preoperative PTH levels were found between groups. Among patients with persistent PTH elevation, 18 had adenoma and 5 had multiglandular disease, compared with 52 with adenoma and 10 with multiglandular disease in patients with normal postoperative PTH levels (P>.05). Multivariate analysis demonstrated that black race and musculoskeletal symptoms were associated with an elevated postoperative PTH level (P =.01. After an average 16-month follow-up, PTH levels normalized in 13 patients, decreased in 5, and were unchanged in 2. Three patients were lost to follow-up. CONCLUSIONS: Persistent PTH elevation occurs in 27% of patients following curative parathyroidectomy and is usually a transient phenomenon more common in patients with musculoskeletal symptoms and of the black race. It is not a manifestation of persistent disease but is most likely a secondary response to bone remineralization.

Adult↗
PubMed2002

The results of ultrasound-guided fine-needle aspiration biopsy for evaluation of nodular thyroid disease.

BACKGROUND: The purpose of this study was to determine whether ultrasonography (US) improves the accuracy and reduces the rate of nondiagnostic fine-needle aspiration biopsy (FNAB) of thyroid nodules. METHODS: A review of 536 consecutive patients evaluated for nodular thyroid disease from 1990 to 2001 was completed to determine the results for US vs palpation-guided FNAB. RESULTS: FNAB was used to evaluate 458 patients. US-guided FNAB was performed in 66 (12%) patients: 48 with a nonpalpable nodule, 14 with nondiagnostic standard FNAB, and 4 with a palpable nodule. US-guided FNAB was nondiagnostic in 15 (23%) patients. There were no false-positive or false-negative results. Standard FNAB was performed in 407 patients, 57 (14%) of whom had a nondiagnostic result. There were 2 (3%) false-positive and 3 (1.6%) false-negative results. In 14 patients with a nondiagnostic standard FNAB, US-guided FNAB yielded an adequate specimen in 7 (50%). Nodules evaluated by standard FNAB were 4.1 +/- 0.1 cm (mean +/- SEM) in size compared with 2.5 +/- 0.1 cm for nodules evaluated by US-guided FNAB (P <.05). CONCLUSIONS: US improves the diagnostic yield in selected patients with nondiagnostic standard FNAB. The higher frequency of nondiagnostic US-guided FNAB was related to its selective use in patients with smaller nodules.

Biopsy, Needle↗
PubMed2002

Early and late outcome of bedside percutaneous tracheostomy in the intensive care unit.

To simplify long-term airway management in critically ill patients the feasibility of performing percutaneous tracheostomy (PT) in the intensive care unit (ICU) was investigated from August of 1997 to March of 2000. Bedside PT was considered for patients with positive end-expiratory pressure <10 cm H20, no previous tracheostomy, no anatomic distortion of the tracheal region, and no other indication to go to the operating room. Indication for tracheostomy, duration of endotracheal intubation, Acute Physiology and Chronic Health Evaluation II (APACHE II) score, morbidity, and mortality were determined. Patients were prospectively followed until decannulation or for a minimum of 3 months. PT was performed in the ICU in 71 patients. Indications for PT were: acute respiratory failure (41), airway protection (26), and maxillofacial trauma (four). Mean duration of intubation before PT was 14 days (range 5-35 days). Average APACHE II score was 14 (range 3-28). Morbidity from PT included: early (two) and late (one) bleeding from the tracheostomy, early cuff leak (one), and self-decannulation (one). Sixteen patients died of causes unrelated to PT. Forty-five patients were decannulated after an average of 57 days (range 9-170 days); two noted a minor voice change. PT can be performed in the ICU with minimal morbidity eliminating the need for an operating room, the risks of patient transport, and the costs associated with each.

Adolescent↗