Comparison of Clinical and Economic Outcomes of an Optimized Lean Versus a Standard Transcatheter Aortic Valve Implantation Program (from SOLAR [Safe Outcomes Lean And Resourceful] Study).

The increasing prevalence of aortic stenosis (AS) and the increasing number of patients indicated for transcatheter aortic valve implantation (TAVI) can lead to increased hospital constraints. This study aimed to compare, from the hospital perspective, the costs, resource use, and 30-day clinical outcomes of patients who underwent TAVI under an optimized or standard clinical pathway. A single-center, retrospective study was conducted among patients with native AS who underwent TAVI between January 2018 and March 2021. Patients who underwent optimized lean TAVI were propensity-score matched 1:1 to those who underwent standard TAVI. In-hospital costs and 30-day clinical outcomes were compared between the 2 groups. A total of 182 patients (91 in each group) were included in the final analysis. Baseline covariates were well balanced after matching. Patients who underwent lean TAVI had shorter length of stay (median [interquartile range] 3.0 days [2.0 to 6.0] vs 6.0 days [5.0 to 9.0], p <0.001). Patients in the lean TAVI group incurred lower total costs than did those in the standard TAVI group (mean ± SD: $41,346 ± 10,062 vs $50,471 ± 15,115, p = 0.002). There was no between-group difference in 30-day all-cause mortality (2.2% vs 1.1%, p = 0.573) and pacemaker implantations (5.5% vs 6.6%, p = 0.788). Rates of procedural complications were comparable between groups. In conclusion, lean TAVI leads to hospital efficiencies without compromising patient safety. Efforts to streamline the TAVI procedure should be encouraged to improve access to TAVI for patients with AS, amid resource constraints.

On-the-Job Safety During Enlarging an Intensive Care Unit for the COVID-19 Pandemic: Team-Based Approach with Low Infection Rate of the Staff.

OBJECTIVE: Healthcare workers had a 7.4-fold risk of severe coronavirus disease-19 than non-essential employees in the United Kingdom during the first phase of the pandemic. In this study, we describe interdisciplinary measures for increasing on-the-job safety used during the first phase of the pandemic in an Italian hospital. METHODS: We converted an intensive care/intermediate care unit into a fully equipped 16-bed intensive care unit with adjustments for infection control and on-the-job safety within 4 days. We compared our actions with a recently published concept on team management in the pandemic and described the implementation of each issue. It was our principal goal in this completely unknown emergency to guarantee safety for both staff and patients. We defined independent pathways for staff, patients, material, and waste. Clear procedures were defined for protecting the employees and for creating a working environment that minimizes mistakes despite challenging conditions. RESULTS: From March 7 to April 29, we treated 34 mechanically ventilated patients in our intensive care unit with a mean bed occupancy rate of 62%. The team worked in the upgraded intensive care unit with an increased perception of safety. After cessation of the first wave of the pandemic, we tested the department's entire staff for antibodies against severe acute respiratory syndrome coronavirus 2. Totally 2 of 122 (1.6%) team members developed anti-severe acute respiratory syndrome coronavirus 2 immunoglobulin-G antibodies during the intensive care unit's running time. CONCLUSION: The successful implementation of theoretical concepts on team management into clinical practice was crucial for staff safety and on-the-job safety during the pandemic.

Long-Term Outcomes After Implantation of Magnesium-Based Bioresorbable Scaffolds-Insights From an All-Comer Registry.

Background: The magnesium-based sirolimus-eluting bioresorbable scaffold (Mg-BRS) Magmaris™ showed promising clinical outcomes, including low rates of both the target lesion failure (TLF) and scaffold thrombosis (ScT), in selected study patients. However, insights regarding long-term outcomes (>2 years) in all-comer populations remain scarce. Methods: We analyzed data from a single-center registry, including patients with acute coronary syndrome (ACS) and chronic coronary syndrome (CCS), who had undergone percutaneous coronary intervention (PCI) using the Mg-BRS. The primary outcome comprised the device-oriented composite endpoint (DoCE) representing a hierarchical composite of cardiac death, ScT, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR) up to 5 years. Results: In total, 84 patients [mean age 62 ± 11 years and 63 (75%) men] were treated with the Mg-BRS devices between June 2016 and March 2017. Overall, 101 lesions had successfully been treated with the Mg-BRS devices using 1.2 ± 0.4 devices per lesion. Pre- and postdilatation using dedicated devices had been performed in 101 (100%) and 98 (97%) of all the cases, respectively. After a median follow-up time of 62 (61-64) months, 14 (18%) patients had experienced DoCEs, whereas ScT was encountered in 4 (4.9%) patients [early ScTs (<30 days) in three cases and two fatal cases]. In 4 (29%) of DoCE cases, optical coherence tomography confirmed the Mg-BRS collapse and uncontrolled dismantling. Conclusion: In contradiction to earlier studies, we encountered a relatively high rate of DoCEs in an all-comer cohort treated with the Mg-BRS. We even observed scaffold collapse and uncontrolled dismantling. This implicates that this metal-based BRS requires further investigation and may only be used in highly selected cases.

Development of a value-based healthcare delivery model for sarcoma patients.

The urgent need to restructure healthcare delivery to address rising costs has been recognised. Value-based health care aims to deliver high and rising value for the patient by addressing unmet needs and controlling costs. Sarcoma is a rare disease and its care is therefore usually not organised as an institutional discipline. It comprises a set of various diagnostic entities and is highly transdisciplinary. A bottom-up approach to establishing sarcoma integrated practice units (IPUs) faces many challenges, but ultimately allows the scaling up of quality and outcomes of patient care, specific knowledge, experience and education. The key for value-based health care - besides defining the shared value of quality - is an integrated information technology platform that allows transparency by sharing values, brings all stakeholders together in real-time, and offers the opportunity to assess quality of care and outcomes, thereby ultimately saving costs. Sarcoma as a rare disease may serve as a model of how to establish IPUs through a supraregional network by increased connectivity, to advance patient care, to improve science and education, and to control costs in the future, thereby restructuring healthcare delivery. This article describes how the value-based health care delivery principles are being adopted and fine-tuned to the care of sarcoma patients, and already partially integrated in seven major referral hospitals in Switzerland.

Impact of Adrenal Function on Hemostasis/Endothelial Function in Patients Undergoing Surgery.

CONTEXT: Glucocorticoids regulate hemostatic and endothelial function, and they are critical for adaptive functions during surgery. No data regarding the impact of adrenal function on hemostasis and endothelial function in the perioperative setting are available. OBJECTIVE: We assessed the association of adrenal response to adrenocorticotropic hormone (ACTH) and markers of endothelial/hemostatic function in surgical patients. METHODS: This prospective observational study, conducted at a tertiary care hospital, included 60 patients (35 male/25 female) undergoing abdominal surgery. Adrenal function was evaluated by low-dose ACTH stimulation test on the day before, during, and the day after surgery. According to their stimulated cortisol level (cutoff ≥ 500 nmol/L), patients were classified as having normal hypothalamic-pituitary-adrenal (HPA)-axis function (nHPA) or deficient HPA-axis function (dHPA). Parameters of endothelial function (soluble vascular cell adhesion molecule-1, thrombomodulin) and hemostasis (fibrinogen, von Willebrand factor antigen, factor VIII [FVIII]) were measured during surgery. RESULTS: Twenty-one patients had dHPA and 39 had nHPA. Compared with nHPA, patients with dHPA had significantly lower peak cortisol before (median 568 vs 425 nmol/L, P < 0.001) and during (693 vs 544 nmol/L, P < 0.001) surgery and lower postoperative hemoglobin levels (116 g/L vs 105 g/L, P = 0.049). FVIII was significantly reduced in patients with dHPA in uni- and multivariable analyses; other factors displayed no significant differences. Coagulation factors/endothelial markers changed progressively in relation to stimulated cortisol levels and showed a turning point at cortisol levels between 500 and 600 nmol/L. CONCLUSIONS: Patients with dHPA undergoing abdominal surgery demonstrate impaired hemostasis which can translate into excessive blood loss.

Improved Procedural Efficiency of Atrial Fibrillation Ablation Using a Dedicated Ablation Protocol and Lean Management.

OBJECTIVES: In this study the authors hypothesized that "Lean management" within a dedicated ablation protocol could standardize the pulmonary vein isolation (PVI) procedure and improve quality. BACKGROUND: There is a large variability in safety, effectiveness, and efficiency of PVI. METHODS: This was a single-center prospective study with inclusion of all consecutive PVI procedures from 2017 to 2019. A 3-step intervention was introduced based on Lean management: step 1) simplification (CLOSE protocol); step 2) waste elimination (higher power shorter duration); and step 3) improved standardization (Lab Optimization Tool [LOT]). PVI was divided into steps that were tracked (in minutes) using LOT. Parameters were compared in 6-month intervals. RESULTS: Overall, 295 patients (146 patients with LOT) were analyzed. Step 1 reduced skin-to-skin procedure duration (2017: 119 ± 21 min vs. 2018: 77 ± 15 min; p < 0.001) and variance (from 2018 to 2019 p = 0.024). Step 2 reduced the radiofrequency time (2017: 38 ± 6 min vs. 2018: 20 ± 3 min; p < 0.001) and variance (from 2018 to 2019 p < 0.001). Analysis of step 3 demonstrated that only 53% of the entire procedure length (143 ± 22 min) was used for treatment (skin-to-skin time 77 ± 16 min), the remaining time being devoted for setup (42 ± 12 min, 29%); left atrial access (16 ± 7 min, 12%); respiratory gating, left atrial map, and pseudo-circle annotation (10 ± 6 min, 7%); ablation (39 ± 10 min, 27%); and bilateral block validation (10 ± 8 min, 7%). CONCLUSIONS: Standardization of PVI using a dedicated ablation protocol and Lean management can help to reduce procedure and radiofrequency ablation duration and variance, and increase procedural efficiency without compromising safety. To improve health care utilization, increased efficiency should become an accepted goal in addition to procedural safety and effectiveness.

Separate Medication Preparation Rooms Reduce Interruptions and Medication Errors in the Hospital Setting: A Prospective Observational Study.

BACKGROUND: Interruptions and errors during the medication process are common, but published literature shows no evidence supporting whether separate medication rooms are an effective single intervention in reducing interruptions and errors during medication preparation in hospitals. We tested the hypothesis that the rate of interruptions and reported medication errors would decrease as a result of the introduction of separate medication rooms. AIM: Our aim was to evaluate the effect of separate medication rooms on interruptions during medication preparation and on self-reported medication error rates. METHODS: We performed a preintervention and postintervention study using direct structured observation of nurses during medication preparation and daily structured medication error self-reporting of nurses by questionnaires in 2 wards at a major teaching hospital in Switzerland. RESULTS: A volunteer sample of 42 nurses was observed preparing 1498 medications for 366 patients over 17 hours preintervention and postintervention on both wards. During 122 days, nurses completed 694 reporting sheets containing 208 medication errors. After the introduction of the separate medication room, the mean interruption rate decreased significantly from 51.8 to 30 interruptions per hour (P < 0.01), and the interruption-free preparation time increased significantly from 1.4 to 2.5 minutes (P < 0.05). Overall, the mean medication error rate per day was also significantly reduced after implementation of the separate medication room from 1.3 to 0.9 errors per day (P < 0.05). CONCLUSIONS: The present study showed the positive effect of a hospital-based intervention; after the introduction of the separate medication room, the interruption and medication error rates decreased significantly.

[Increasing Complexity in Performance Delivery - Management Approach for Tertiary Care Centers]. / Komplexitätssteigerung in der Leistungserstellung ­ Managementansätze für ein Zentrumsspital.

Increasing Complexity in Performance Delivery - Management Approach for Tertiary Care Centers Abstract. General social trends such as individualization and female shift increase the complexity for management in both technical and system management in addition to the inherent development in the hospital industry such as subspecialization, ageing societies and multimorbidity. Reduction of complexity is therefore absolutely necessary in order to be able to manage in a patient-friendly way as a maximum care provider. Reducing complexity means resolving therapeutic conflicts. Essential tools for this are digitization, a comprehensive quality paradigm that includes patient experience, patient assessment of treatment outcomes, indication and service quality, and good management. The latter integrates the fragmentation of skills and knowledge of a subspecialized medicine through appropriate system design. This requires the appropriate functional strategies and a comprehensive process management competence that can transform the numerous interfaces into seams.

Effect of intraoperative infiltration with local anesthesia on the development of chronic pain after inguinal hernia repair: a randomized, triple-blinded, placebo-controlled trial.

BACKGROUND: Chronic pain is a common complication after inguinal hernia repair. The objective of this randomized trial was to assess the effect of intraoperative infiltration with local anesthetic versus placebo on the development of chronic pain after inguinal hernia repair. METHODS: Patients with single- or double-sided inguinal hernia were enrolled in a randomized, controlled, triple-blinded trial with a sequential adaptive design. Hernias were randomized to 1 of 2 treatment groups. The intervention group received a local infiltration of 20 mL bupivacaine 0.25% and the placebo group 20 mL saline 0.9% at the end of the operation. Two interim analyses were performed according to predefined stopping criteria allowing for design and sample size adaption. The primary endpoint was chronic pain defined on a visual analog scale (VAS) as ≥30 in any quality (at rest, lying, walking, climbing stairs, and bending over) 3 months postoperatively. A logistic regression model was built to compare the incidence of chronic pain using generalized estimating equations to adjust for clustering in bilateral hernias. RESULTS: Among 357 patients, there were 406 hernias randomized. A total of 5.8% (10/173) experienced VAS ≥ 30 in any quality in the intervention group and 2.3% (4/174) in the placebo group (P = .114) at 3 months postoperatively. Multivariable analysis revealed no evidence of between-group differences for the development of any pain (odds ratio [OR], 1.03; 95% CI, 0.67-1.57; P = .905), whereas preoperative pain was an independent risk factor (OR, 2.52; 95% CI, 1.12-5.68; P = .025). CONCLUSION: We did not find any evidence that intraoperative infiltration of local anesthetic had an impact on the development of chronic postoperative pain.

[OR-Management - Essentials]. / OP-Management - Essentials.

Operating theaters are strongly linked to other units in a hospital such as the ICU, the wards and the emergency room for example. Good management skills are necessary to improve the productivity by 2-3 percent per year. To reach these goals resources' such as personnel, IT-systems, specific equipment and the adherence to professional standards are required. Information exchange and sharing between the different professional stake holders are the important prerequisites for success. OR managers should focus on logistics, IT-systems, capacity planning, quality standards and communications. The coordination of the daily workflow should be delegated using proper rules and standards and being supported by IT. Efficiency of the unit is important, but should never over rule patient outcome and safety.

[OR management - Checklists for OR-design for OR-managers - results of a workshop]. / OP-Management - OP-Designchecklisten für OP-Manager - Ergebnisse eines Workshops.

The construction of an operating room (OR) suite represents an important intermediate- and long term investment. The planning process starts with the quantitative estimation of the procedures to be carried out which defines the operative capacity for the life time of the facility. This permits the calculation of the number of ORs and the definition of the resources for the recovery room, the intermediate care and intensive care unit.The projectors should integrate the new facility into workflow, workload and logistics of the entire hospital. The simulation flow of patients and accompanying persons and of the routes of the personnel is helpful for this purpose. Separating structures for outpatients from those for inpatients and avoiding de-centralized rooms helps designing an efficient and safe OR suite.The design of the single ORs should be flexible to permit changes or technical innovations during their use period. Mobile equipment is preferable to permanently installed devices. We consider an expanse of at least 45 m(2) for any location adequate for general ORs. The space requirements are elevated for hybrid ORs and rooms dedicated for robotic surgery.The design of the suite should separate the flow of personnel, patients and logistics. Surgical instruments and their logistics should be standardized. Dedicated locations for a simultaneous preparation of the instrumentation tables permit parallel processing. Thus an adequate capacity of preparation rooms and storage rooms is necessary. Dressing rooms, rest rooms, showers and lounges are important for the working conditions and should be planned in an adequate size and number.

[OR-management and self-improvement - a discrepancy?]. / OP-Management - OP-Management†/†effiziente Klinikführung und Weiterbildung - ein Widerspruch?

Today, operating room management is essential for a modern hospital. The strategic controls of this cost-intensive area and the ongoing cost pressure have necessitated management attention to this area. Economical, processual and quality data are well-known and established, although analysis of different health delivering organisations by benchmarking is still difficult. It remains still a severe task for the management of an OR and anaesthesia department. For these fields data is needed to identify and measure the performance of these departments in the dimensions of finances, development, processes and patient's needs. The key performance indicators are exemplified for an anaesthesia department and discussed.

Telemedicine in the management of diving accidents: correlation of phone-assessed symptom severity with clinical findings.

INTRODUCTION: The object of this study was to evaluate to what extend the severity of decompression illness (DCI) assessed by a diving medicine specialist over the phone correlates with actual clinical findings. METHODS: The phone protocols of calls received by a diving medical hotline between January 2008 and December 2009 were analysed. Each case was followed up after completion of the treatment and categorized into one out of four severity groups according to the same standard protocol used for categorisation at the time of the initial hotline call. RESULTS: In 47 of 151 calls, DCI was suspected by the hotline experts. The initial estimation was coherent with the clinical findings in 37 cases, 9 were overestimated and one was underestimated. With the 95% bootstrap confidence interval 0.551 to 0.864 and computed weighted Cohen's κ coefficient = 0,721, the coherence between hotline assessment and clinical assessment can be considered as good. The five divers with minimal symptoms who were categorised as "no DCI possible" could not be followed up. CONCLUSION: We conclude that, despite some limitations to the study, particularly the limited sample size, a reliable assessment of the severity of DCI can be provided by a specialist-based telephone hotline.

Tensile strength decreases and perfusion pressure of 3-holed polyamide epidural catheters increases in long-term epidural infusion.

BACKGROUND AND OBJECTIVES: Epidural analgesia is an established method for pain management. The failure rate is 8% to 12% due to technical difficulties (catheter dislocation and/or disconnection; partial or total catheter occlusion) and management. The mechanical properties of the catheters, like tensile strength and flow rate, may also be affected by the analgesic solution and/or the tissue environment. METHOD: We investigated the tensile strength and perfusion pressure of new (n=20), perioperatively (n=30), and postoperatively (n=73) used epidural catheters (20-gauge, polyamide, closed tip, 3 side holes; Perifix [B. Braun]). To prevent dislocation, epidural catheters were taped (n=5) or fixed by suture (n=68) to the skin. After removal, mechanical properties were assessed by a tensile-testing machine (INSTRON 4500), and perfusion pressure was measured at flow rates of 10, 20, and 40 mL/h. RESULTS: All catheters demonstrated a 2-step force transmission. Initially, a minimal increase of length could be observed at 15 N followed by an elongation of several cm at additional forces (7 N). Breakage occurred in the control group at 23.5±1.5 N compared with 22.4±1.6 N in perioperative and 22.4±1.7 N in postoperative catheters (P<0.05). Duration of catheter use had no effect on tensile strength, whereas perfusion pressure at clinically used flow rates (10 mL/h) increased significantly from 19±1.3 to 44±72 mm Hg during long-term (≥7 days) epidural analgesia (P<0.05, analysis of variance). Fixation by suture had no influence on tensile strength or perfusion pressure. CONCLUSIONS: Epidural catheter use significantly increases the perfusion pressure and decreases the tensile strength.

Status quo and current trends of operating room management in Germany.

PURPOSE OF REVIEW: Ongoing healthcare reforms in Germany have required strenuous efforts to adapt hospital and operating room organizations to the needs of patients, new technological developments, and social and economic demands. This review addresses the major developments in German operating room management research and current practice. RECENT FINDINGS: The introduction of the diagnosis-related group system in 2003 has changed the incentive structure of German hospitals to redesign their operating room units. The role of operating room managers has been gradually changing in hospitals in response to the change in the reimbursement system. Operating room managers are today specifically qualified and increasingly externally hired staff. They are more and more empowered with authority to plan and control operating rooms as profit centers. For measuring performance, common perioperative performance indicators are still scarcely implemented in German hospitals. In 2008, a concerted time glossary was established to enable consistent monitoring of operating room performance with generally accepted process indicators. These key performance indicators are a consistent way to make a procedure or case - and also the effectiveness of the operating room management - more transparent. SUMMARY: In the presence of increasing financial pressure, a hospital's executives need to empower an independent operating room management function to achieve the hospital's economic goals. Operating room managers need to adopt evidence-based methods also from other scientific fields, for example management science and information technology, to further sustain operating room performance.

Long-acting local anesthetics attenuate FMLP-induced acute lung injury in rats.

BACKGROUND: Endothelin-1 (ET-1) is a mediator of lung diseases and a potent pulmonary vasoconstrictor. In addition to thromboxane A2, it participates in the formation of lung edema. Both lidocaine and mepivacaine attenuate the increase of pulmonary arterial pressure (PAP) and lung edema development. We examined the effects of procaine, bupivacaine, and ropivacaine on experimentally evoked PAP increase and ET-1 release. METHODS: PAP and lung weight were measured in isolated rat lungs during perfusion with Krebs-Henseleit hydroxyethyl starch buffer. Bupivacaine, ropivacaine, or procaine was added to the solution at concentrations of 10(-2)-10(-7) mg/kg. ET-1 levels were measured in the perfusate by enzyme-immunoassay, and thromboxane A2 levels were assayed by radioimmunoassay. N-formyl-L-leucine-methionyl-L-phenylalanine was used to activate human polymorphonuclear neutrophils. RESULTS: Bupivacaine, ropivacaine, and procaine significantly attenuated increases of PAP (P < 0.05) and resulted in a reduction of lung weight in these treatment groups compared with the sham group (P < 0.05). The long-acting anesthetics bupivacaine and ropivacaine (P < 0.05), but not procaine, reduced ET-1 levels, produced low inflammation rates, and did not affect lung structures at doses from 10(-3) to 10(-6) mg/kg. CONCLUSION: Bupivacaine and ropivacaine attenuated N-formyl-L-leucine-methionyl-L-phenylalanine-induced PAP, reduced lung edema, and diminished ET-1 release. Lidocaine and mepivacaine are more effective in reducing PAP and edema formation, but long-acting local anesthetics also inhibit ET-1 depletion and therefore have increased anti-inflammatory properties.