Biomedical subjects

M Baggish

Publications and source records attributed to M Baggish.

3 recordsLinked to original sources

PubMed1998

Assessment of the safety of intrauterine instillation of heated saline for endometrial ablation.

OBJECTIVE: To evaluate the safety of pressure, temperature-controlled, continuously circulating hot saline (EnAbl system, InnerDyne Medical, Sunnyvale, CA) for endometrial ablation using the in vivo human uterus. DESIGN: Clinical safety study. SETTING: An academic research environment. PATIENTS: Eleven women undergoing abdominal hysterectomy because of abnormal uterine bleeding. INTERVENTION: Before uterine removal, endometrial cavities were exposed to 15 minutes of recirculatory normal saline heated to 70-85 degrees C. MAIN OUTCOME MEASURE(S): The uteri were analyzed for extent of thermal damage using standard histopathological techniques and tissue viability histochemical staining. Intrauterine pressures and serosal and subserosal temperatures were continuously monitored by computer. RESULT(S): In each treated specimen, histochemical staining demonstrated a depth of necrosis that extended through the entire endometrium and approximately 1-2 mm into the myometrium. The control specimen showed no thermal or mechanical damage. There were no observed negative effects or related complications with this system. CONCLUSION(S): The computer-controlled system employing continuously circulating hot saline is an effective method to destroy the endometrium. In four cases with clearly patent tubes, no spill was observed. In all 11 patients, serosal and subserosal temperatures were within safe levels (mean temperature, 37 degrees C).

Adult↗

PubMed1997

[Endometrial ablation by liquid heat using the EnAbl system in patients after abdominal hysterectomy. Study of safety].

Security and efficacy of an EnABL, were evaluated; this system had been designed for endometrial ablation by liquid heat in uterine cavity. Eleven patients were included, from the Outpatient Department (INP), programmed for different causes that objectives of this study for abdominal hysterectomy due to abnormal uterine bleeding. The study was approved by Ethical and Scientific Committees. Each patient had preoperative studies, endometrial biopsy, PAP, and ultrasound, in series. The patients with uterus larger than 14 cm, possible cancer; younger than 18 year, or with active bleeding at the time of hysterectomy, were excluded. Each patient received a schema of standard endometrial suppression. The system was applied previously to TAH; 2271 measurements of temperature at one minute intervals were done during liquid heat application. Surgical pieces were sent to histology to analyze the thermic damage through macroscopic aspect, HE tinction and an immunohistochemical cellular viability of NADH test. The thermal damage by macroscopic appearance was 4.33 +/- 1.03 mm, with HE of 4.15 +/- 0.75 mm and with the tinction of NADH of 4.25 mm +/- 0.79. The maximal damage by macroscopic appearance was 4.33 +/- 1.03 mm, with HE of 4.15 +/- 0.75 mm, and with NADH it was 4.25 mm +/- 0.79. The maximal damage was by macroscopic appearance was 6.0 mm and the minimal one was 2.0 mm. In evaluation by H/E, maximal was 5.1 mm and the minimal one was 2.3 mm. In NADH tinction maximal was 4.25 and minimal 2.4 mm. Horizontal analysis showed eight patients with major thermal damage at 4 mm; and two patients with lesser damage at 4 mm. Sub-serous temperatures measured with thermopairs, were done 1504 times, in total. Average was 36.28 degrees C, ranging 35 to 37 degrees C. Maximal temperature was 45 degrees C, 1-2 mm, bellow from serous surface of uterus, and the last one was 28 degrees C. The serous temperatures measured by infrared radiation were done 767 times with an average temperature of 34.6 degrees C. Average was 34-35 C, with standard deviation of 1-2 degrees C. Maximal temperature was 40 degrees C and minimal 29 degrees C. There were no adverse effects. This study shows that EnAbl system is an efficacious method.

Catheter Ablation↗

PubMed1995

A computer-controlled, continuously circulating, hot irrigating system for endometrial ablation.

OBJECTIVE: This study evaluated the efficacy of a computer-controlled thermal catheter system to ablate the endometrium by use of 5 to 15 ml of hot saline solution. STUDY DESIGN: Five in vivo sheep uteri and 32 freshly excised human uteri were studied by inserting a self-contained heater catheter equipped with thermocouples and circulating hot saline solution for 15 minutes within the uteri at various temperature settings ranging from 60 degrees C to 80 degrees C. The uteri were grossly examined and microscopically evaluated by hematoxylin and eosin and reduced nicotinamide adenine dinucleotide-diaphorase stains for degree of acute destruction, depth of thermal injury, and predicted viability. RESULTS: All 80 degrees C sheep treatments resulted in complete loss of viability at mucosal, submucosal, and myometrial levels. In human uteri temperatures > or = 80 degrees C produced grossly recognizable thermal damage to the endometrium. Full-thickness irreversible damage was seen in the endometrium. Loss of viability was also demonstrated 1 to 3 mm deep in the superficial myometrium. Intrauterine pressure was demonstrated to range from 20 to 40 mm Hg, with a mean of 26 mm Hg. No leakage of fluid from the oviducts was observed. CONCLUSION: The data presented here demonstrate that a simple technique coupled with a sophisticated monitoring control system could successfully ablate the endometrium without the vagaries associated with individual operator skill levels.

Animals↗