Perioperative complications after pacemaker implantation: higher complication rates with subclavian vein puncture than with cephalic vein cutdown.

PURPOSE: The cephalic vein cutdown (CVC) and the subclavian puncture (SP) is the most common access for pacemaker implantation. The purpose of this study was to compare the peri-/postoperative complications of these approaches. METHODS: A retrospective analysis of the quality assurance data of the state of North Rhine-Westphalia was performed to evaluate the peri-/postoperative complications of first pacemaker implantation according to the venous access. The primary endpoint was defined as the occurrence of one of the following: asystole, ventricular fibrillation, pneumothorax, hemothorax, pericardial effusion, pocket hematoma, lead dislocation, lead dysfunction, postoperative wound infection or other complication requiring intervention. Descriptive analysis was done via absolute, relative frequencies and Odds Ratio. Fisher's exact test was used for comparison of the both study groups. RESULTS: From 139,176 pacemaker implantations from 2010 to 2014, 15,483 cases were excluded due to other/double access. The median age was 78 years and the access used was CVC for 75,251 cases (60.8%) and SP for 48,442 cases (39.2%). The implanted devices were mainly dual-chamber pacemakers (73.9% in the CVC group and 78.4% in the SP group), followed by single-chamber pacemakers VVI (24.9% and 19.9% in the CVC and SP group respectively). There were significantly fewer peri/postoperative complications in the CVC group compared to the SP group (2.49% vs. 3.64%, p = 0.0001, OR 1.47; 95% CI 1.38-1.57). CONCLUSIONS: CVC as venous access for pacemaker implantation has significantly fewer peri/postoperative complications than SP and appears to be an advantageous technique.

[Considerations for quality assurance of discussions with relatives in direct association with organ donation]. / Überlegungen für eine Qualitätssicherung der Angehörigengespräche in einem unmittelbaren Zusammenhang mit einer Organspende.

BACKGROUND: Discussions with relatives are relevant and crucial aspects of the organ donation process and contribute to a consolidated and sustainable decision by the families of the deceased. Despite the great importance of family care, there is no systematic analysis of the quality of this communication, in contrast to the diagnosis of irreversible loss of brain function, organ retrieval and organ transplantation. For this reason, organ donation experts were interviewed about recurring characteristics of communication with relatives of the deceased. The aim of this qualitative study was to define criteria for the assessment of the structure and quality of the communication process with relatives for internal quality management in Germany. METHODS: Based on a systematic literature review and with the help of the 5­stage S2PS2 (system for creating a questionnaire) procedure according to Kruse, interview guidelines were initially developed. As a second step, in guideline-based interviews 10 experienced organ donation experts were questioned about structural, procedural and ethical aspects of their discussions with relatives. Following the interviews, a software-based qualitative content analysis was carried out with a combined inductive-deductive category system. Finally, the first quality assurance measures for the interviews with relatives were developed in a multistep process, closely following the methodological principles V1.1 of the Institute for Quality Assurance and Transparency in Health Care (IQTIG). The individual research steps were accompanied by an expert group consisting of physicians, nurses, theologians and ethicists utilizing an anonymous Delphi procedure. RESULTS: In the qualitative content analysis, 5 main categories with 30 subcategories on quality relevant aspects could be identified (including, standardization and technique of conversation, interview framework and context factors, professional expertise of the interviewers, wishes of the organ donation experts). On this basis, 6 criteria for the structural quality and 7 criteria for the process quality of the discussions with relatives were formulated and summarized in a respective quality bundle. These criteria address, among other things, interprofessional communication, structured training concepts, regular further training of all team members, use of standardized communication and counselling strategies as well as documented preliminary meetings and debriefings, including supervising elements. They emphasize interdisciplinary professionalism and process management in a protected environment as well as quality assured communication and documentation. Recommendations were made for expanding the existing documentation for the organ donation process and for documenting the preliminary meetings and debriefings. CONCLUSION: Recurring communication and process characteristics as well as requirements for the members of the treatment team who conduct the conversation can be identified for the interviews with relatives, which show potential for improvement to various degrees. This justifies the structured derivation of a quality bundle for the structural and process quality family care related to organ donation, which should enable a low-threshold entry into an institution internal systematic quality assessment of communication with relatives in Germany. Due to the different legal, medical and social specifics in an international context, the study results cannot be directly transferred to other countries.

[Perioprocedural mortality after ICD implantation]. / Peripoperative Mortalität nach ICD-Implantation.

BACKGROUND: Implantable cardioverter defibrillators (ICD) represent an established treatment in preventing sudden cardiac death in patients with indications for primary or secondary prophylaxis. As for all complex surgical procedures there remains a risk for the occurrence of complications including death also for ICD implantation. The aim of the present study was to analyze the procedure-related mortality in patients after ICD implantation using the data from the obligatory quality assurance program in North-Rhine/Westphalia. METHODS: Data of all 18,625 patients from the quality assurance datasets who underwent ICD implantation in the years 2010-2012 were analyzed. RESULTS: During the in-hospital stay 118 patients (0.6%) died after ICD implantation. Patients > 80 years old had a higher mortality (1.9% vs. 0.5% in patients < 80 years old, p < 0.001) as well as women (0.95% vs. 0.54% in men, p = 0.004) and patients with higher New York Heart Association (NYHA) class (0.3% for NYHA II, 0.7% for NYHA III, 3.4% for NYHA IV, p < 0.001 for all comparisons). The presence of diabetes mellitus (23% of the collective) did not influence the perioperative mortality, whereas renal failure requiring dialysis showed a significantly increased mortality (p < 0.001 compared to patients with creatinine ≤ 1.5 mg/dl and p = 0.002 for patients with creatinine > 1.5 mg/dl not requiring dialysis). Patients with indications for ICD secondary prophylaxis had a significantly higher mortality (1.2% vs. 0.4%, p < 0.001), which increased from 0.6% to 3.7% (p < 0.001) with the occurrence of complications. CONCLUSION: The procedure-related mortality after ICD implantation is increased in patients over 80 years of age, higher NYHA class, patients requiring dialysis, in secondary prevention indications and after the occurrence of perioperative complications.

Outcome of acute perforated cholecystitis: a register study of over 5000 cases from a quality control database in Germany.

BACKGROUND: Acute perforated cholecystitis (APC) is probably the most severe complication of acute cholecystitis. However, data on the outcome of cholecystectomy for APC are limited to small series. This study investigated the outcomes of cholecystectomy for APC. METHODS: Data from a prospectively maintained quality control database in Germany were analyzed. Cases with APC were compared to cases without gallbladder perforation with regard to demographic characteristics, clinical findings and surgical outcomes. RESULTS: A total of 5704 patients with APC were compared to 39,661 patients without perforation. Risk factors for APC included: the male gender, advanced age (>65 years), ASA score >2, elevated white blood count (WBC), positive findings on abdominal ultrasound sonography and fever. The APC group differed significantly from the control group with regard to fever (29.8 vs. 12.2 %), elevated WBC (83.8 vs. 65.4 %) and positive findings from ultrasound sonography (84.9 vs. 78.9 %), p < 0001. Preoperative computed tomography (CT) was ordered significantly more often in the APC group compared to the control group (2.3 vs. 1.0 %, p = 0.001). Surgery lasted significantly longer in the APC group (92.3 ± 40.8 vs. 73.7 ± 34.1, p < 0.001). The rates of conversion (18.9 vs. 6.8 %), bile duct injury (1.4 vs. 0.5 %), re-intervention (6.9 vs. 2.9 %) and mortality (4.3 vs. 1.3 %) were significantly higher in the APC group (p < 0.001). Similarly, the length of stay (13.4 ± 11.4 vs. 9.0 ± 8.3, p < 0.001) was significantly longer in the APC group. CONCLUSION: Acute perforated cholecystitis is a severe complication of acute cholecystitis. Surgical dissection could be challenging with high risks of bile duct injury and conversion. The rates of morbidity and mortality are higher compared to those of patients without perforation.

Surgical management of empyematous cholecystitis: a register study of over 12,000 cases from a regional quality control database in Germany.

BACKGROUND: Acute cholecystitis is a common indication for surgery. Surgical outcomes depend among other factors on the extent of gallbladder inflammation. Data on the outcomes of patients undergoing cholecystectomy due to acute empyematous cholecystitis are rare. METHODS: Data from a prospectively maintained quality control database in Germany were analyzed. Cases with empyematous cholecystitis were compared to cases without gallbladder empyema with regard to baseline features, clinical parameters and surgical outcomes. RESULTS: A total of 12,069 patients with empyematous cholecystitis (EC) were compared to 33,296 patients without empyema. The male gender, advanced age, ASA score >2, elevated white blood count and fever were confirmed as risk factors for EC. The EC group differed significantly from the control group with regard to fever (28.0 vs. 9.5 %), elevated WBC (82.5 vs. 62.3 %) and positive findings from ultrasound sonography (87.4 vs. 76.9 %), p < 0001. Surgery lasted significantly longer in the EC group (86.1 ± 38.5 vs. 72.2 ± 33.6, p < 0.001). The rates of conversion (15.2 vs. 5.8 %), bile duct injury (0.8 vs. 0.4 %), re-intervention (5.5 vs. 2.6 %) and mortality (2.8 vs. 1.2 %) were significantly higher in the EC group, p < 0.001. Similarly, the length of stay (11.9 ± 10.5 vs. 8.8 ± 8.3, p < 0.001) was significantly longer in the EC group. CONCLUSION: Empyematous cholecystitis is a severe form of acute cholecystitis with high rates of morbidity and mortality. Even the experienced laparoscopic surgeon should expect dissection difficulties, therefore the threshold for conversion in order to prevent bile duct injury should be low.

Interinstitutional variations in mode of birth after a previous caesarean section: a cross-sectional study in six German hospitals.

AIMS: Regional and interinstitutional variations have been recognized in the increasing incidence of caesarean section. Modes of birth after previous caesarean section vary widely, ranging from elective repeat caesarean section (ERCS) and unplanned repeat caesarean section (URCS) after trial of labour to vaginal birth after caesarean section (VBAC). This study describes interinstitutional variations in mode of birth after previous caesarean section in relation to regional indicators in Germany. MATERIAL AND METHODS: A cross-sectional study using the birth registers of six maternity units (n=12,060) in five different German states (n=370,209). Indicators were tested by χ2 and relative deviations from regional values were expressed as relative risks and 95% confidence intervals. RESULTS: The percentages of women in the six units with previous caesarean section ranged from 11.9% to 15.9% (P=0.002). VBAC was planned for 36.0% to 49.8% (P=0.003) of these women, but actually completed in only 26.2% to 32.8% (P=0.66). Depending on the indicator, the units studied deviated from the regional data by up to 32% [relative risk 0.68 (0.47-0.97)] in respect of completed VBAC among all initiated VBAC. CONCLUSIONS: There is substantial interinstitutional variation in mode of birth following previous caesarean section. This variation is in addition to regional patterns.