Implementation of the "No ICU - Unless" approach in postoperative neurosurgical management in times of COVID-19.

Following elective craniotomy, patients routinely receive 24-h monitoring in an intensive care unit (ICU). However, the benefit of intensive care monitoring and treatment in these patients is discussed controversially. This study aimed to evaluate the complication profile of a "No ICU - Unless" strategy and to compare this strategy with the standardized management of post-craniotomy patients in the ICU. Two postoperative management strategies were compared in a matched-pair analysis: The first cohort included patients who were managed in the normal ward postoperatively ("No ICU - Unless" group). The second cohort contained patients routinely admitted to the ICU (control group). Outcome parameters contained detailed complication profile, length of hospital and ICU stay, duration to first postoperative mobilization, number of unplanned imaging before scheduled postoperative imaging, number and type of intensive care interventions, as well as pre- and postoperative modified Rankin scale (mRS). Patient characteristics and clinical course were analyzed using electronic medical records. The No ICU - Unless (NIU) group consisted of 96 patients, and the control group consisted of 75 patients. Complication rates were comparable in both cohorts (16% in the NIU group vs. 17% in the control group; p = 0.123). Groups did not differ significantly in any of the outcome parameters examined. The length of hospital stay was shorter in the NIU group but did not reach statistical significance (average 5.8 vs. 6.8 days; p = 0.481). There was no significant change in the distribution of preoperative (p = 0.960) and postoperative (p = 0.425) mRS scores in the NIU and control groups. Routine postoperative ICU management does not reduce postoperative complications and does not affect the surgical outcome of patients after elective craniotomies. Most postoperative complications are detected after a 24-h observation period. This approach may represent a potential strategy to prevent the overutilization of ICU capacities while maintaining sufficient postoperative care for neurosurgical patients.

Genome-wide association study of myocardial infarction, atrial fibrillation, acute stroke, acute kidney injury and delirium after cardiac surgery - a sub-analysis of the RIPHeart-Study.

BACKGROUND: The aim of our study was the identification of genetic variants associated with postoperative complications after cardiac surgery. METHODS: We conducted a prospective, double-blind, multicenter, randomized trial (RIPHeart). We performed a genome-wide association study (GWAS) in 1170 patients of both genders (871 males, 299 females) from the RIPHeart-Study cohort. Patients undergoing non-emergent cardiac surgery were included. Primary endpoint comprises a binary composite complication rate covering atrial fibrillation, delirium, non-fatal myocardial infarction, acute renal failure and/or any new stroke until hospital discharge with a maximum of fourteen days after surgery. RESULTS: A total of 547,644 genotyped markers were available for analysis. Following quality control and adjustment for clinical covariate, one SNP reached genome-wide significance (PHLPP2, rs78064607, p = 3.77 × 10- 8) and 139 (adjusted for all other outcomes) SNPs showed promising association with p < 1 × 10- 5 from the GWAS. CONCLUSIONS: We identified several potential loci, in particular PHLPP2, BBS9, RyR2, DUSP4 and HSPA8, associated with new-onset of atrial fibrillation, delirium, myocardial infarction, acute kidney injury and stroke after cardiac surgery. TRIAL REGISTRATION: The study was registered with ClinicalTrials.gov NCT01067703, prospectively registered on 11 Feb 2010.

A Multicenter Trial of Remote Ischemic Preconditioning for Heart Surgery.

BACKGROUND: Remote ischemic preconditioning (RIPC) is reported to reduce biomarkers of ischemic and reperfusion injury in patients undergoing cardiac surgery, but uncertainty about clinical outcomes remains. METHODS: We conducted a prospective, double-blind, multicenter, randomized, controlled trial involving adults who were scheduled for elective cardiac surgery requiring cardiopulmonary bypass under total anesthesia with intravenous propofol. The trial compared upper-limb RIPC with a sham intervention. The primary end point was a composite of death, myocardial infarction, stroke, or acute renal failure up to the time of hospital discharge. Secondary end points included the occurrence of any individual component of the primary end point by day 90. RESULTS: A total of 1403 patients underwent randomization. The full analysis set comprised 1385 patients (692 in the RIPC group and 693 in the sham-RIPC group). There was no significant between-group difference in the rate of the composite primary end point (99 patients [14.3%] in the RIPC group and 101 [14.6%] in the sham-RIPC group, P=0.89) or of any of the individual components: death (9 patients [1.3%] and 4 [0.6%], respectively; P=0.21), myocardial infarction (47 [6.8%] and 63 [9.1%], P=0.12), stroke (14 [2.0%] and 15 [2.2%], P=0.79), and acute renal failure (42 [6.1%] and 35 [5.1%], P=0.45). The results were similar in the per-protocol analysis. No treatment effect was found in any subgroup analysis. No significant differences between the RIPC group and the sham-RIPC group were seen in the level of troponin release, the duration of mechanical ventilation, the length of stay in the intensive care unit or the hospital, new onset of atrial fibrillation, and the incidence of postoperative delirium. No RIPC-related adverse events were observed. CONCLUSIONS: Upper-limb RIPC performed while patients were under propofol-induced anesthesia did not show a relevant benefit among patients undergoing elective cardiac surgery. (Funded by the German Research Foundation; RIPHeart ClinicalTrials.gov number, NCT01067703.).

Remote ischaemic preconditioning for heart surgery. The study design for a multi-center randomized double-blinded controlled clinical trial--the RIPHeart-Study.

AIMS: Transient ischaemia of non-vital tissue has been shown to enhance the tolerance of remote organs to cope with a subsequent prolonged ischaemic event in a number of clinical conditions, a phenomenon known as remote ischaemic preconditioning (RIPC). However, there remains uncertainty about the efficacy of RIPC in patients undergoing cardiac surgery. The purpose of this report is to describe the design and methods used in the "Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart)-Study". METHODS: We are conducting a prospective, randomized, double-blind, multicentre, controlled trial including 2070 adult cardiac surgical patients. All types of surgery in which cardiopulmonary bypass is used will be included. Patients will be randomized either to the RIPC group receiving four 5 min cycles of transient upper limb ischaemia/reperfusion or to the control group receiving four cycles of blood pressure cuff inflation/deflation at a dummy arm. The primary endpoint is a composite outcome (all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure) until hospital discharge. CONCLUSION: The RIPHeart-Study is a multicentre trial to determine whether RIPC may improve clinical outcome in cardiac surgical patients.

Associated risk of recombinant activated factor VIIa application.

BACKGROUND: The recombinant human coagulation FVIIa was approved for the treatment of bleeding in hemophilia patients. The reports of a good hemostatic effect were followed by studies and applications without a regulatory extension of the therapeutic indication (off-label use). The aim of this retrospective study is the evaluation of thromboembolic adverse events and side effects in a large cohort of patients with FVIIa therapy. METHODS: In the period from January 2009 to March 2011, a total of 143/2453 (5.8%) cardiac surgical patients (69% male; age 67 ± 11 years; 39% thoracic aorta) were treated with different doses (mean, 6.1 mg; range, 1 to 27.2 mg) of factor VIIa. The administration of FVIIa was seen as a last therapeutic option and administered at the end of the treatment algorithm for severe bleeding. RESULTS: Due to an acute bleeding situation in 143 patients, 7.9 ± 5.8 units of packed red blood cells, 9.5 ± 6.1 units of fresh frozen plasma, 1740 ± 1860 IU PPSB (Prothrombin-Proconvertin-Stuart Factor-Antihemophilic Factor B), 5.6 ± 4 g fibrinogen, and 7.9 ± 7.6 units of platelets were administered. A re-thoracotomy was necessary, despite maximal procoagulant therapy, in 55% of patients. The in-hospital mortality was 36% (51/2453 = 2%). Thrombotic complications occurred with a frequency of 16% (mesenteric infarction, n = 9; stroke/transient ischemic attack, n = 3; myocardial infarction, n = 3; other, n = 8). CONCLUSION: The proof of direct causality of the events in relation to the administration of FVIIa is difficult because the temporal and therapeutic relationships with concomitant vasoconstrictive and procoagulant therapies were not obvious. However, there remains a suspicion that a higher rate of mesenteric infarctions may be provoked by the administration of FVIIa.

Efficacy of Intraoperative Blood Salvage in Cerebral Aneurysm Surgery.

BACKGROUND: The use and effectiveness of intraoperative cell salvage has been analyzed in many surgical specialties. Until now, no data exist evaluating the efficacy of intraoperative cell salvage in cerebral aneurysm surgery. AIM: To evaluate the efficacy and cost effectiveness of intraoperative cell salvage in cerebral aneurysm surgery. METHODS: Data were collected retrospectively for all the patients who underwent cerebral aneurysm surgery at our institution between 2013 and 2019. Routinely, we apply blood salvage through autotransfusion. The cases were divided into a ruptured cerebral aneurysm group and a unruptured cerebral aneurysm group. RESULTS: A total of 241 patients underwent cerebral aneurysm clipping. Of all the cerebral aneurysms, 116 were ruptured and 125 were unruptured and clipped electively. Age, location of the aneurysm, postoperative red blood cell count, intraoperative blood loss, and number of allogenic blood cell transfusions were statistically significantly different between the groups. The autotransfusion of salvaged blood could only be facilitated in eight cases with ruptured cerebral aneurysms and in none with unruptured cerebral aneurysms clipped electively (p < 0.01). Additionally, 35 patients with ruptured cerebral aneurysms and one patient with unruptured cerebral aneurysm required allogenic red blood cell transfusion after surgery, and 71 vs. 2 units of blood were transfused (p < 0.0001). In terms of cost effectiveness, a total of EUR 45,189 in 241 patients was spent to run the autotransfusion system, while EUR 13,797 was spent for allogenic blood transfusion. CONCLUSIONS: The use of cell salvage in patients with unruptured cerebral aneurysm, undergoing elective surgery, is not effective.

Dexmedetomidine as adjunct in awake craniotomy - improvement or not?

BACKGROUND: Over the last decade, awake craniotomy for tumor resection has become a standard to maximize tumor resection and minimize the risk of permanent neurological deficits. Different techniques and medication regimes have been tested for this procedure. Until today there is no consensus on the optimal approach. Therefore, we investigated the effect of dexmedetomidine as an adjunct in awake cerebral tumor surgery and evaluated our improved technique. METHODS: Data of patients who underwent awake craniotomy for tumor resection at our institution between 09/2006 and 05/2018 were retrospectively analyzed. All patients were kept awake after cortical mapping. After changing our standard anesthetic procedure from propofol/remifentanil alone to propofol/remifentanil and dexmedetomidine, we performed an evaluation of time to arousal, drug dosages, patients' cooperation and the occurrence of periprocedural adverse events. RESULTS: Eighty-four patients received propofol/remifentanil alone (SG). A further 17 patients additionally received dexmedetomidine following craniotomy in order to induce rapid arousal (DG). In the dexmedetomidine group a significantly reduced infusion time for propofol (169.2 ± 47.4 vs. 212.9 ± 63.3 minutes; P = 0.008) and non-significantly shorter time to arousal (12.0 [10.0/16.5] vs. 15.0 [10.0/20.0] minutes; P = 0.271) could be identified. In general, the overall procedure was very well tolerated by all patients. CONCLUSIONS: The asleep-awake technique is a well-accepted and safe procedure. It allows continuous surveillance of the patient's neurological function during tumor resection and the postoperative phase, minimizing complications. In addition, our data show that the use of dexmedetomidine results in a shorter time to arousal.

Rapid ventricular pacing for clip reconstruction of complex unruptured intracranial aneurysms: results of an interdisciplinary prospective trial.

OBJECTIVE To date, treatment of complex unruptured intracranial aneurysms (UIAs) remains challenging. Therefore, advanced techniques are required to achieve an optimal result in treating these patients safely. In this study, the safety and efficacy of rapid ventricular pacing (RVP) to facilitate microsurgical clip reconstruction was investigated prospectively in a joined neurosurgery, anesthesiology, and cardiology study. METHODS Patients with complex UIAs were prospectively enrolled. Both the safety and efficacy of RVP were evaluated by recording cardiovascular events and outcomes of patients as well as the amount of aneurysm occlusion after the surgical clip reconstruction procedure. A questionnaire was used to evaluate aneurysm preparation and clip application under RVP. RESULTS Twenty patients (mean age 51.6 years, range 28-66 years) were included in this study. Electrode positioning was easy in 19 (95%) of 20 patients, and removal of electrodes was easily accomplished in all patients (100%). No complications associated with the placement of the pacing electrodes occurred, such as cardiac perforation or cardiac tamponade. RVP was applied in 16 patients. The mean aneurysm size was 11.1 ± 5.5 mm (range 6-30 mm). RVP proved to be a very helpful tool in aneurysm preparation and clip application in 15 (94%) of 16 patients. RVP was used for a mean duration of 60 ± 25 seconds, a mean heart rate of 173 ± 23 bpm (range 150-210 bpm), and a reduction of mean arterial pressure to 35-55 mm Hg. RVP leads to softening of the aneurysm sac facilitating its mobilization, clip application, and closure of the clip blades. In 2 patients, cardiac events were documented that resolved without permanent sequelae in both. In every patient with successful RVP (n = 14) a total or near-total aneurysm occlusion was documented. In the 1 patient in whom the second RVP failed due to pacemaker electrode dislocation, additional temporary clipping was required to secure the aneurysm, but was not as sufficient as RVP. This led to an incomplete clipping of the aneurysm and finally a remnant on postoperative digital subtraction angiography. A pacemaker lead dislocation occurred in 3 (19%) of 16 patients, but intraoperative repositioning requires less than 20 seconds. Outcome was favorable in all patients according to the modified Rankin Scale. CONCLUSIONS To the best of the authors' knowledge this is the first prospective interdisciplinary study of RVP use in patients with UIAs. RVP is an elegant technique that facilitates clip reconstruction in complex UIAs. The safety of the procedure is good. However, because this procedure requires extensive preoperative cardiological workup of the patient and an experienced neurosurgery and neuroanesthesiology team with much cerebrovascular expertise, actually it remains reserved for selected elective cases and highly specialized centers. Clinical trial registration no.: NCT02766972 (clinicaltrials.gov).

General Anesthesia Versus Local Anesthesia in Stereotactic Biopsies of Brain Lesions: A Prospective Randomized Study.

BACKGROUND: Stereotactic biopsy of brain lesions with unknown entities is a common neurosurgical procedure to obtain tumor tissue. Pathologists can then provide an exact diagnosis on which further therapy, such as resection, radiotherapy, or chemotherapy, can be based. These procedures can be performed under local or general anesthesia. In this prospective study, we aim to show whether stress levels are higher for patients who undergo stereotactic biopsy under local or general anesthesia. METHODS: Between January 2013 and December 2014, we screened 157 patients. Of these, 43 were included and evaluated in this study. Twenty-one patients gave their written consent and were randomized for either local or general anesthesia. A Post Traumatic Stress Score (PTSS) questionnaire was filled out by the patients preoperatively and postoperatively. Also, patients who did not agree to randomization had an opportunity to fill out the PTSS questionnaire. Twenty-two patients agreed only to fill out the stress-level questionnaire but refused randomization. These patients were evaluated as a subgroup. Scores achieved in the PTSS were compared by using the Fisher exact test. RESULTS: Among the randomized patients, 9 underwent the procedure under local anesthesia and 12 under general anesthesia. Median PTSS was 24 preoperatively in the patients who received local anesthesia versus 20 among the patients with general anesthesia (P = 0.37; Fisher exact test). Postoperatively, PTSS was 29.5 in median for patients with local anesthesia versus 23 for patients with general anesthesia (P = 0.30; Fisher exact test). Postoperatively, the PTSS showed a median increase of 5.5 points in the LA and 3 points in the GA group (P = 0.87; Fisher exact test). P values of 0.05 and lower were considered statistically significant. CONCLUSIONS: The willingness of patients to undergo randomization in this setting was low (13.3%). Within this highly selective group of patients, there was no significant difference for stress levels in patients who underwent stereotactic biopsy under local anesthesia versus general anesthesia. However, median values indicate a trend for higher stress-level values for patients undergoing local anesthesia.