The Vancouver 3M (Multidisciplinary, Multimodality, But Minimalist) Clinical Pathway Facilitates Safe Next-Day Discharge Home at Low-, Medium-, and High-Volume Transfemoral Transcatheter Aortic Valve Replacement Centers: The 3M TAVR Study.

OBJECTIVES: The authors sought to prospectively determine the safety and efficacy of next-day discharge using the Vancouver 3M (Multidisciplinary, Multimodality, but Minimalist) Clinical Pathway. BACKGROUND: Transfemoral transcatheter aortic valve replacement (TAVR) is an alternative to surgery in high- and intermediate-risk patients; however, hospital stays average at least 6 days in most trials. The Vancouver 3M Clinical Pathway is focused on next-day discharge, made possible by the use of objective screening criteria as well as streamlined peri- and post-procedural management guidelines. METHODS: Patients were enrolled from 6 low-volume (<100 TAVR/year), 4 medium-volume, and 3 high-volume (>200 TAVR/year) centers in Canada and the United States. The primary outcomes were a composite of all-cause death or stroke by 30 days and the proportion of patients successfully discharged home the day following TAVR. RESULTS: Of 1,400 screened patients, 411 were enrolled at 13 centers and received a SAPIEN XT (58.2%) or SAPIEN 3 (41.8%) valve (Edwards Lifesciences, Irvine, California). In centers enrolling exclusively in the study, 55% of screened patients were enrolled. The median age was 84 years (interquartile range: 78 to 87 years) with a median STS score of 4.9% (interquartile range: 3.3% to 6.8%). Next-day discharge home was achieved in 80.1% of patients, and within 48 h in 89.5%. The composite of all-cause mortality or stroke by 30 days occurred in 2.9% (95% confidence interval: 1.7% to 5.1%), with neither component of the primary outcome affected by hospital TAVR volume (p = 0.51). Secondary outcomes at 30 days included major vascular complication 2.4% (n = 10), readmission 9.2% (n = 36), cardiac readmission 5.7% (n = 22), new permanent pacemaker 5.7% (n = 23), and >mild paravalvular regurgitation 3.8% (n = 15). CONCLUSIONS: Adherence to the Vancouver 3M Clinical Pathway at low-, medium-, and high-volume TAVR centers allows next-day discharge home with excellent safety and efficacy outcomes.

Evaluation of a Clinical Protocol to Assess and Diagnose Neuropathic Pain During Acute Hospital Admission: Results From Traumatic Spinal Cord Injury.

OBJECTIVES: A clinical protocol was developed for clinicians to routinely assess and initiate treatment for patients with neuropathic pain (NP) in an acute care setting. The objectives of this study were to: (1) determine the incidence and onset of NP in patients with traumatic spinal cord injury during acute care and (2) describe how the implementation of a clinical protocol impacts the assessment and diagnosis of NP. MATERIALS AND METHODS: The study was a cohort analysis with a pre-post-test utilizing a historical control. Data were retrospectively collected from a patient registry and charts. Participants were randomly selected in cohort 1 (control) and cohort 2 (NP clinical protocol). RESULTS: The incidence of NP was 56% without significant difference between the cohorts (P=0.3). Onset of NP was 8 days (SD=14) across the study and >85% of the participants with NP were diagnosed within 2 weeks. Participants with incomplete injuries had a significant earlier onset than participants with complete injuries (6.2±12.8, 10.9±15.8 d; P=0.003). The mean number of days from hospital admission to initial assessment decreased with use of the NP clinical protocol (3.7±5.7 d; P=0.02). DISCUSSION: This study demonstrates a high incidence and early onset of NP in traumatic spinal cord injury during acute hospital care, with an earlier emergence in participants with incomplete injury. The NP clinical protocol ensured continuous assessment and documentation of NP while decreasing the time to an initial screen, but did not impact diagnosis.

Cerebrospinal fluid inflammatory cytokines and biomarkers of injury severity in acute human spinal cord injury.

There is an urgent need for both the scientific development and clinical validation of novel therapies for acute spinal cord injury (SCI). The scientific development of novel therapies would be facilitated by a better understanding of the acute pathophysiology of human SCI. Clinical validation of such therapies would be facilitated by the availability of biomarkers with which to stratify injury severity and predict neurological recovery. Cerebrospinal fluid (CSF) samples were obtained over a period of 72 h in 27 patients with complete SCI (ASIA A) or incomplete SCI (ASIA B or C). Cytokines were measured in CSF and serum samples using a multiplex cytokine array system and standard enzyme-linked immunosorbent assay (ELISA) techniques. Neurological recovery was monitored, and patient-reported neuropathic pain was documented. IL-6, IL-8, MCP-1, tau, S100beta, and glial fibrillary acidic protein (GFAP) were elevated in a severity-dependent fashion. A biochemical model was established using S100beta, GFAP, and IL-8 to predict injury severity (ASIA A, B, or C). Using these protein concentrations at 24-h post injury, the model accurately predicted the observed ASIA grade in 89% of patients. Furthermore, segmental motor recovery at 6 months post injury was better predicted by these CSF proteins than with the patients' baseline ASIA grade. The pattern of expression over the first 3 to 4 days post injury of a number of inflammatory cytokines such as IL-6, IL-8, and MCP-1 provides invaluable information about the pathophysiology of human SCI. A prediction model that could use such biological data to stratify injury severity and predict neurological outcome may be extremely useful for facilitating the clinical validation of novel treatments in acute human SCI.

Intrathecal pressure monitoring and cerebrospinal fluid drainage in acute spinal cord injury: a prospective randomized trial.

OBJECT: Ischemia is an important factor in the pathophysiology of secondary damage after traumatic spinal cord injury (SCI) and, in the setting of thoracoabdominal aortic aneurysm repair, can be the primary cause of paralysis. Lowering the intrathecal pressure (ITP) by draining CSF is routinely done in thoracoabdominal aortic aneurysm surgery but has not been evaluated in the setting of acute traumatic SCI. Additionally, while much attention is directed toward maintaining an adequate mean arterial blood pressure (MABP) in the acute postinjury phase, little is known about what is happening to the ITP during this period when spinal cord perfusion pressure (MABP - ITP) is important. The objectives of this study were to: 1) evaluate the safety and feasibility of draining CSF to lower ITP after acute traumatic SCI; 2) evaluate changes in ITP before and after surgical decompression; and 3) measure neurological recovery in relation to the drainage of CSF. METHODS: Twenty-two patients seen within 48 hours of injury were prospectively randomized to a drainage or no-drainage treatment group. In all cases a lumbar intrathecal catheter was inserted for 72 hours. Acute complications of headache/nausea/vomiting, meningitis, or neurological deterioration were carefully monitored. Acute Spinal Cord Injury motor scores were documented at baseline and at 6 months postinjury. RESULTS: On insertion of the catheter, mean ITP was 13.8 +/- 1.3 mm Hg (+/- SD), and it increased to a mean peak of 21.7 +/- 1.5 mm Hg intraoperatively. The difference between the starting ITP on catheter insertion and the observed peak intrathecal pressure after decompression was, on average, an increase of 7.9 +/- 1.6 mm Hg (p < 0.0001, paired t-test). During the postoperative period, the peak recorded ITP in the patients randomized to the no-drainage group was 30.6 +/- 2.3 mm Hg, which was significantly higher than the peak intraoperative ITP (p = 0.0098). During the same period, the peak recorded ITP in patients randomized to receive drainage was 28.1 +/- 2.8 mm Hg, which was not statistically higher than the peak intraoperative ITP (p = 0.15). CONCLUSIONS: The insertion of lumbar intrathecal catheters and the drainage of CSF were not associated with significant adverse events, although the cohort was small and only a limited amount of CSF was drained. Intraoperative decompression of the spinal cord results in an increase in the ITP measured caudal to the injury site. Increases in intrathecal pressure are additionally observed in the postoperative period. These increases in intrathecal pressure result in reduced spinal cord perfusion that will otherwise go undetected when measuring only the MABP. Characteristic changes in the observed intrathecal pressure waveform occur after surgical decompression, reflecting the restoration of CSF flow across the SCI site. As such, the waveform pattern may be used intraoperatively to determine if adequate decompression of the thecal sac has been accomplished.

A pulsatile pressure waveform is a sensitive marker for confirming the location of the thoracic epidural space.

OBJECTIVES: The purpose of this study was to assess the validity of using a pulsatile, pressure waveform transduced from the epidural space through an epidural needle or catheter to confirm correct placement for maximal analgesia and to compare 3 different types of catheters' ability to transduce a waveform. DESIGN: A single-center, prospective, randomized trial. SETTING: A tertiary-referral hospital. PARTICIPANTS: Eighty-one patients undergoing posterolateral thoracotomy who required a thoracic epidural catheter for postoperative pain management. INTERVENTIONS: Each epidural needle and each epidural catheter was transduced to determine if there was a pulsatile waveform exhibited. MEASUREMENTS AND MAIN RESULTS: Sensitivity of the pulsatile waveform transduced through an epidural needle to identify correct placement of the epidural needle and the sensitivity of each catheter type to identify placement were compared. In 79 of 81 cases (97.5%), the waveform transduced directly through the epidural needle had a pulsatile characteristic as determined by blinded observers. In a total of 53 of 81 epidural catheters (65.4%), the transduced waveform displayed pulsations. Twenty-four of 27 catheters in group S-P/Sims Portex (Smiths Medical MD, Inc, St Paul, MN) (88.9%) transduced a pulsatile tracing from the epidural space, a significantly greater percentage than in the other 2 groups (p = 0.02). CONCLUSIONS: The technique of transducing the pressure waveform from the epidural needle inserted in the epidural space is a sensitive and reliable alternative to other techniques for confirmation of correct epidural catheter placement. The technique is simple, sensitive, and inexpensive and uses equipment available in any operating room.

Prospective randomized clinical trial comparing patient-controlled intravenous analgesia with patient-controlled epidural analgesia after lumbar spinal fusion.

STUDY DESIGN: A prospective, randomized, double-blind clinical trial was conducted. OBJECTIVE: To compare the efficacy of patient-controlled analgesia (PCA) with that of patient-controlled epidural analgesia (PCEA) in terms of overall patient satisfaction with postoperative pain management after lumbar spine fusion. SUMMARY OF BACKGROUND DATA: In numerous surgical disciplines, PCEA and PCA have proved to be effective methods of postoperative pain control. The literature states that with PCEA, less opioid use is required during the immediate postoperative period to maintain equivalent pain control compared to PCA. Continuous epidural infusion has been assessed in spine fusion patients, but PCEA has not been evaluated. Furthermore, this is the first prospective randomized clinical trial to assess overall patient satisfaction while stratifying patients for both anxiety level and preoperative opioid use. METHODS: For this study, 74 patients were assigned randomly to one of two treatment groups, with PCA and PCEA administered in a double-blind manner for a 3-day postoperative course. All the patients received both PCA and PCEA delivery systems. Assessment was by a blinded, independent observer. Overall patient satisfaction with pain management was assessed by a visual analog scale at the end of postoperative day 3. Secondary measures included: three scales from the Functional Independence Measure instrument; opioid quantity; side effects; and length of hospital stay. RESULTS: Thirty-eight patients were randomized to PCA, and 36 were randomized to PCEA. No baseline variable differences between the groups were observed. The results showed no difference between the groups on the following measures: overall patient satisfaction with pain management, ambulation, and length of stay. The PCA patients used significantly more opioid than the PCEA patients. CONCLUSIONS: Both postoperative analgesic regimens provided good overall patient satisfaction. The only clinical advantage of PCEA over PCA for spine fusion patients was the lower amount of opioid consumed, although the PCEA group experienced significantly more side effects than the PCA group. There were no other significant differences. Therefore, patient or physician preference could select either postoperative pain management delivery system.