Safety, Feasibility, and Hemodynamic Effects of Mild Hypothermia in Transcatheter Aortic Valve Replacement: The TAVR-CHILL Trial (original) (raw)
Related papers
PLOS ONE, 2017
Introduction Transcatheter Aortic Valve Replacement (TAVR) procedures at our institution were complicated by perioperative hypothermia despite use of the standard of care forced-air convective warming device (the BairHugger, Augustine Medical Inc, Eden Prairie, MN, USA). To remedy this problem, we initiated a quality improvement process that investigated the use of a conductive warm water-circulating device (the Allon ThermoWrap, Menen Medical Corporation, Trevose, PA, USA), and hypothesized that it would decrease the incidence of perioperative hypothermia. Methods We compared two different intraoperative warming devices using a historic control. We retrospectively reviewed intraoperative records of 80 TAVRs between 6/2013 and 6/2015, 46 and 34 of which were done with the forced-air and water-circulating devices, respectively. Continuous temperature data obtained from pulmonary artery catheter, temperature upon arrival to cardiothoracic ICU (CTU), age, BSA, height, and BMI were compared. Results Patients warmed with both devices were similar in terms of demographic characteristics. First recorded intraoperative temperature (mean 36.26 ± SD 0.61 vs. 35.95 ± 0.46˚C, p = 0.02), lowest intraoperative temperature (36.01 ± 0.58 vs. 34.89 ± 0.76˚C, p<0.001), temperature at the end of the procedure (36.47 ± 0.51 vs. 35.17 ± 0.75˚C, p<0.001), and temperature upon arrival to the CTU (36.35 ± 0.44 vs. 35.07 ± 0.78˚C, p<0.001) were significantly higher in the water-circulating group as compared to the forced-air group. Conclusion A quality improvement process led to selection of a new warming device that virtually eliminated perioperative hypothermia at our institution. Patients warmed with the new device
Journal of Cardiothoracic Surgery, 2011
Background: Transcatheter aortic valve implantation via the transapical approach (TAVI-TA) without cardiopulmonary bypass (CPB) is a minimally invasive alternative to open-heart valve replacement. Despite minimal exposure and extensive draping perioperative hypothermia still remains a problem. Methods: In this observational study, we compared the effects of two methods of thermal management on the perioperative course of core temperature. The methods were standard thermal management (STM) with a circulating hot water blanket under the patient, forced-air warming with a lower body blanket and warmed infused fluids, and an intensified thermal management (ITM) with additional prewarming using forced-air in the preoperative holding area on the awake patient. Results: Nineteen patients received STM and 20 were treated with ITM. On ICU admission, ITM-patients had a higher core temperature (36.4 ± 0.7°C vs. 35.5 ± 0.9°C, p = 0.001), required less time to achieve normothermia (median (IQR) in min: 0 (0-15) vs. 150 (0-300), p = 0.003) and a shorter period of ventilatory support (median (IQR) in min: 0 (0-0) vs. 246 (0-451), p = 0.001). Conclusion: ITM during TAVI-TA reduces the incidence of hypothermia and allows for faster recovery with less need of ventilatory support.
Critical Care
Background: The aim of this study was to explore the performance and outcomes for intravascular (IC) versus surface cooling devices (SFC) for targeted temperature management (TTM) after out-of-hospital cardiac arrest. Methods: A retrospective analysis of data from the Time-differentiated Therapeutic Hypothermia (TTH48) trial (NCT01689077), which compared whether TTM at 33°C for 48 h results in better neurologic outcomes compared with standard 24-h duration. Devices were assessed for the speed of cooling and rewarming rates. Precision was assessed by measuring temperature variability (TV), i.e., the standard deviation (SD) of all temperature measurements in the cooling phase. Main outcomes were overall mortality and poor neurological outcome, including death, severe disability, or vegetative status. Results: A total of 352 patients had available data and were included in the analysis; of those, 218 (62%) were managed with IC. A total of 114/218 (53%) patients with IC and 61/134 (43%) with SFC were cooled for 48 h (p = 0.22). Time to target temperature (≤ 34°C) was significantly shorter for patients treated with endovascular devices (2.2 [1.1-4.0] vs. 4.2 [2.7-6.0] h, p < 0.001), but temperature was also lower on admission (35.0 [34.2-35.6] vs. 35.3 [34.5-35.8]°C; p = 0.02) and cooling rate was similar (0.4 [0.2-0.8] vs. 0.4 [0.2-0.6]°C/h; p = 0.14) when compared to SFC. Temperature variability was significantly lower in the endovascular device group when compared with SFC methods (0.
Circulation, 2015
Background-Targeted temperature management is recommended after out-of-hospital cardiac arrest. Whether advanced internal cooling is superior to basic external cooling remains unknown. The aim of this multicenter, controlled trial was to evaluate the benefit of endovascular versus basic surface cooling. Methods and Results-Inclusion criteria were the following: age of 18 to 79 years, out-of-hospital cardiac arrest related to a presumed cardiac cause, time to return of spontaneous circulation <60 minutes, delay between return of spontaneous circulation and inclusion <240 minutes, and unconscious patient after return of spontaneous circulation and before the start of cooling. Exclusion criteria were terminal disease, pregnancy, known coagulopathy, uncontrolled bleeding, temperature on admission <30°C, in-hospital cardiac arrest, immediate need for extracorporeal life support or hemodialysis. Patients were randomized between 2 cooling strategies: endovascular femoral devices (Icy catheter, Coolgard, Zoll, formerly Alsius; n=203) or basic external cooling using fans, a homemade tent, and ice packs (n=197). The primary end point, that is, favorable outcome evaluated by survival without major neurological damage (Cerebral Performance Categories 1-2) at day 28, was not significantly different between groups (odds ratio, 1.41; 95% confidence interval, 0.93-2.16; P=0.107). Improvement in favorable outcome at day 90 in favor of the endovascular group did not reach significance (odds ratio, 1.51; 95% confidence interval, 0.96-2.35; P=0.07). Time to target temperature (33°C) was significantly shorter and target hypothermia was more strictly maintained in the endovascular than in the surface group (P<0.001). Minor side effects directly related to the cooling method were observed more frequently in the endovascular group (P=0.009). Conclusion-Despite better hypothermia induction and maintenance, endovascular cooling was not significantly superior to basic external cooling in terms of favorable outcome.
Successful Transcutaneous Pacing in 2 Severely Hypothermic Patients
Annals of Emergency Medicine, 2007
The clinical condition of profound hypothermia is well described in the medical literature. There have been many case reports and studies describing successful aspects of caring for this problem. Significant bradycardia is a known pathophysiologic consequence of profound hypothermia. Transcutaneous pacing for this condition is not a routine or recommended practice in the literature. This case report details 2 patients with profound hypothermia and resultant bradycardia with hypotension. In both cases, transcutaneous pacing was successfully applied and used as part of the resuscitation. In both cases, transcutaneous pacing was required to maintain an adequate blood pressure so that continuous arteriovenous rewarming could be used during the resuscitation. Both cases had successful outcomes, and the rewarming process was greatly assisted by the pacing procedure. [Ann Emerg Med.
Interactive cardiovascular and thoracic surgery, 2015
Aortic valve replacement (AVR) in patients with severely atherosclerotic aortas (porcelain aorta) presents a significant technical challenge. Two strategies are deep hypothermic circulatory arrest (DHCA) during conventional surgery and transcatheter aortic valve replacement (TAVR). The aim of this study was to examine the outcomes in patients who underwent DHCA for AVR with a porcelain aorta to identify whether older patients are more suitable for TAVR. Between October 2004 and December 2012, 122 patients underwent AVR using DHCA for atherosclerotic aorta. Patients with concomitant valve surgery were excluded. Overall, 63.9% (78/122) were of age <80 (non-octogenarian group, NOG) and 36.1% (44/122) were >80 (octogenarian group, OG). Of the total cohort, 62.3% (76/122) had concomitant coronary artery bypass graft surgery. The mean age for the whole cohort was 75.7 ± 8.5 years; 70.2 ± 8.1 years for the NOG and 83.4 ± 2.6 years for the OG (P = 0.001). The OG had a higher rate of p...
Texas Heart Institute journal / from the Texas Heart Institute of St. Luke's Episcopal Hospital, Texas Children's Hospital, 1985
Twenty patients underwent elective cardiac valve replacement at 20 degrees C of body hypothermia. Temperatures of the ventricles of both walls were monitored on 12 different sites. Distribution of myocardial temperature ranged between 24.3 and 29.3 degrees C for patients of Group I before cardioplegia delivery and 13.2 degrees C in the septum after cardioplegic infusion. Average temperatures for the anterior and posterior wall were 13.6 C and 15 degrees C in the left ventricle and 14.7 and 15 degrees C in the right ventricle. Myocardial temperatures ranged from 26 to 28.7 degrees C for patients of Group II. After cardioplegic arrest, septal temperatures averaged 14.9 degrees C. The recorded sites of the anterior and posterior left ventricle were 14.1 and 13.1 degrees C. The effects of rewarming on the different myocardial areas occurred according to a logarithmic equation, which is faster in the first 10 minutes. The data suggest that the myocardium can be adequately protected with ...
Therapeutic Hypothermia and Temperature Management, 2019
Targeted temperature management (TTM) is recommended postcardiac arrest. The cooling method with the highest safety and efficacy is unknown. The COOL-ARREST pilot trial aimed to evaluate the safety and efficacy of the most contemporary ZOLL Thermogard XP Intravascular Temperature Management (IVTM) system for providing mild TTM postcardiac arrest. This multicenter, prospective, single-arm, observational pilot trial enrolled patients at eight U.S. hospitals between July 28, 2014, and July 24, 2015. Adult (q18 years old), out-of-hospital cardiac arrest subjects of presumed cardiac etiology who achieved return of spontaneous circulation (ROSC) were considered for inclusion. Patients were excluded if (1) awake or consistently following commands after ROSC, (2) significant prearrest neurological dysfunction, (3) terminal illness or advanced directives precluding aggressive care, and (4) severe hemodynamic instability or shock. Patient temperature was maintained at 33.0°C-0.3°C for a total of 24 hours followed by controlled rewarming (0.1-0.2°C/h). Logistic regressions were used to assess association of good functional outcome (modified Rankin Scale p3) measured at the time of hospital discharge with shockable rhythm (yes/no), age, gender, race/ethnicity, lay-rescuer cardiopulmonary resuscitation, time to basic life support (minutes), time to ROSC (minutes), lactate (mg/dL), and pH on admission. The ZOLL IVTM system was effective at inducing TTM (median time to target temperature from initiation, 89 minutes [interquartile range 42-155]). Adverse events most often included electrolyte abnormalities and dysrhythmias. Of patients surviving to hospital discharge, 16/20 patients had a good functional outcome. A total of 18 patients survived through 90-day follow-up, at which time 94% (17/18) of patients had good functional outcome. The COOL-ARREST pilot trial demonstrates high safety and efficacy of the ZOLL Thermogard XP IVTM system in the application of mild TTM postcardiac arrest. This observational trial also revealed noteworthy variability in the management of postcardiac arrest patients, particularly with the use of early withdrawal of life-sustaining therapy.