Ensuring accountability: the contribution of the cohort review method to tuberculosis control in New York City.

SETTING: In 1993, the New York City (NYC) Bureau of Tuberculosis Control developed the cohort review process as a quality assurance method to track and improve patient outcomes. METHODS: The Bureau Director reviews every tuberculosis (TB) case quarterly in a multi-disciplinary staff meeting. In 2004 we also began collecting details on issues identified at cohort review to quantify how this process directly impacts TB control efforts. RESULTS: From 1992 to 2004, NYC TB cases decreased by 72.7% and treatment success rates significantly increased by 26.7%. Implementing the cohort review was key to improving case management, thus leading to these results. For the 1039 patients in 2004, 596 issues were identified among 424 patients; 55.0% were incorrect, unclear or unknown patient information, 13.8% were treatment issues, 12.4% were case management issues and 10.6% were incomplete contact investigations. Most (76.5%) issues were addressed within 30 days of the cohort reviews. CONCLUSION: A systematic review of every TB case improves the quality of patient information, enhances patient treatment and ensures accountability at all levels of the TB control program.     

Postoperative handling in biliodigestive derivation by iatrogenic bile duct injury

Bile duct injury is a severe complication related to cholecystectomy, impacting in the long-term quality of life and functional status. Bile duct repair is the first-line treatment for complex injuries. During short-term and long-term postoperative care, it is important to bear in mind the diagnostic tools, both laboratory and imaging, that will be useful to evaluate a possible surgical complication and to plan an adequate therapeutic strategy. In addition, post-surgical classification describes patients according to their complications and clinical course. In this review we describe the principal issues of postoperative care after bile duct repair, highlighting the diagnosis, severity classification and therapeutic approach of acute cholangitis.     

Computerized assessment of complications after colorectal surgery

PURPOSE: Historically, complication rates after colorectal surgery have been stratified by disease process, type of operation, or anesthesia risk derived after an intensive review of the medical record. Newer computer applications purport to shorten this process and predict the probability of postoperative complications by distinguishing them from comorbidities that are commingled on uniform discharge codes. We analyzed CaduCIS software, which uses discharge codes, to determine whether its predictions of comorbidity and complications were comparable to what was interpreted on the medical record. METHODS: Two-hundred seventy patients were analyzed according to the principal and secondary diagnoses coded on discharge. Coding inaccuracies of clinical occurrences were identified by physician review of each medical record. The actual incidences of 17 common preoperative comorbidities and 11 postoperative complications were compared with those predicted by CaduCIS. RESULTS: The CaduCIS-predicted distribution of comorbidities was similar to the actual occurrences in 15 of 17 categories. The overall incidence of complications obtained by physician (actual) review was 47 percent, compared with 46 percent predicted by CaduCIS. However, there was a statistical difference between the CaduCIS-predicted and the actual complication rates in 5 of the 11 categories. The most common preoperative comorbidity and complication was cardiopulmonary (47 percent and 28 percent, respectively). CONCLUSION: The overall complication rate interpreted from the medical record (47 percent) was accurately predicted by CaduCIS (46 percent). Predictions of 5 of 11 individual complications were underestimated because of charting and coding inaccuracies, not because of computerized errors. Because uniform discharge coding of commingled comorbidity and complications is increasingly used to rapidly compute surgical outcomes, colon and rectal surgeons need to ensure compatibility of the actual and coded medical records.     

The safety of bronchoscopy in a pulmonary fellowship program

STUDY OBJECTIVE: To determine the complication rate from supervised training bronchoscopy in a single pulmonary fellowship program, and to examine the effects of fellow and faculty experience on this complication rate. DESIGN: A retrospective review of preexisting quality improvement data from one center for the time period July 1, 1991, until June 30, 2005, was performed. The data were stratified based on the fellow year group and the staff experience level. The types of complications were recorded. SETTING: The study was performed at an accredited pulmonary and critical care fellowship program at a military medical center in the United States. PARTICIPANTS: Fifty-one pulmonary and critical care medicine fellows and 20 staff supervising physicians performed the bronchoscopies that were included in this study. RESULTS: A total of 3,538 training bronchoscopies were performed during the study period with 73 complications for a complication rate of 2.06%. The most common complication was pneumothorax. The overall complication rates for first-year fellows (1stYFs), second-year fellows, and third-year fellows were not significantly different from the total complication rate. Training bronchoscopies supervised by junior staff had a complication rate not significantly different from that of senior staff. The cumulative complication rate for the first trimester for 1stYFs was 3.1%, whereas the cumulative complication rate for the second plus the third trimester for 1stYFs was 1.57% (p < 0.05). CONCLUSIONS: Training bronchoscopy performed during a pulmonary fellowship is a safe procedure in a supervised setting. Patients undergoing bronchoscopy performed by novice bronchoscopists have an increased complication rate during the first trimester of bronchoscopist training.     

Improved patient care using the A/S/G/E guidelines on quality assurance: a prospective comparative study

The American Society for Gastrointestinal Endoscopy has promulgated guidelines on quality assurance in gastrointestinal endoscopy. Thorough documentation of endoscopy reports and a peer review process were strongly recommended. We evaluated 1408 dictated endoscopy and colonoscopy reports for deficiency in reference to the guidelines during three periods: 6 months before (group 1), 6 months after the application of the guidelines (group 2), and 5 months of intensive peer review process (group 3). Deficiency was defined as lack of documentation of at least 1 of the 10 parameters that should be included in endoscopy reports according to the guidelines. There was a significant decrease in deficiency rates in groups 2 (91.6%) and 3 (32.7%) compared with group 1 (99.8%) (p less than 0.01). Peer review and direct confrontation of the endoscopists with their deficiencies significantly reduced the use of inappropriate indication for endoscopy (1.5%/group 3 vs. 5.2%/group 1, p less than 0.01). Adherence to the A/S/G/E guidelines on quality assurance improved documentation, decreased inappropriate use of endoscopy, and may thus improve quality of care.     

MELD Scores and Child–Pugh Classifications Predict the Outcomes of ERCP in Cirrhotic Patients With Choledocholithiasis: A Retrospective Cohort Study

Endoscopic retrograde cholangiopancreatography (ERCP) is challenging in cirrhotic patients with choledocholithiasis. We evaluated the safety and efficacy of ERCP in cirrhotic patients with choledocholithiasis and accessed the model for end-stage liver disease (MELD) scores and Child–Pugh classifications for prediction of morbidity and mortality.From January 2000 to June 2014, 77 ERCP operations were performed in cirrhotic patients with choledocholithiasis. The data on operative complications were analyzed. MELD scores and Child–Pugh classifications were calculated and associated with operative outcomes and survival. Telephone follow-up was performed to determine survival situations.No death, perforation, or hemorrhage caused by gastroesophageal varices occurred as a result of the procedure. The rate of intraoperative hemorrhage was 13.0%, and the rate of postoperative morbidity was 27.3% including hemorrhage (18.2%), post-ERCP pancreatitis (6.1%), aggravated infection of the biliary tract (1.3%), hepatic encephalopathy (1.3%), and respiratory failure (1.3%). Four (5.2%) patients had both intraoperative and postoperative hemorrhage. Receiver operating characteristic analysis identified MELD scores higher than 11.5 as the best cutoff value for predicting complication incidence (95% confidence interval = 0.63–0.87). Twenty-one (44.7%) patients with a MELD score above 11.5 developed a complication, and 3 (10%) patients who had a lower MELD score developed a complication (P = 0.001). Both MELD score and Child–Pugh classification had prognostic value in patients without jaundice, although sex may result in different prognostic values based on the 2 scores. The rate of complications was not significantly different among patients with different Child–Pugh classifications. No significant difference was observed in patients with different MELD scores or Child–Pugh classifications in terms of median survival times.ERCP is an effective and safe procedure in cirrhotic patients with choledocholithiasis. MELD scores can predict the risk of operative complications, but Child–Pugh classification system scores do not predict the risk of complications.     

A comparison of implicit and explicit methods of process quality assurance for blunt trauma patients

We compared explicit (objective) and implicit (subjective) methods of process quality assurance to understand how the findings of each method are related. The charts of 100 blunt trauma patients who were admitted to the ICU, underwent surgery, or died in the emergency department were reviewed for compliance with six explicit process-of-care criteria previously established by the ED faculty. The results of this explicit review were compared with the results of an ongoing quality assurance program that uses implicit review. In the implicit review, a faculty member reviewed patients' charts and responded to three questions regarding the process of care. All blunt trauma patients who met the admission criteria were to be included in this review. Only 44 of the 100 charts were subjected to implicit review. Of these, 26 were judged satisfactory by both methods, two were judged unsatisfactory by both methods, two failed only the implicit review, and 14 failed only the explicit review. The null hypothesis, that the two methods were equivalent, was rejected (McNemar's test, P less than .003). These results suggest that process-of-care assessments of the quality of care must be interpreted with caution as they are method dependent and may not correlate with patient outcomes.     

Verapamil administration to patients with contraindications: is it associated with adverse outcomes?

STUDY OBJECTIVES: To determine if the use of verapamil in patients with contraindications is associated with adverse sequelae, thereby assessing whether process measures of the quality of care are correlated with patient outcomes. DESIGN: Retrospective chart review comparing the incidence of adverse outcomes and drug failure in patients with and without contraindications to verapamil administration. SETTING: University hospital emergency department. PARTICIPANTS: All patients more than 12 years old who received IV verapamil during the study period. MEASUREMENTS: The presence or absence of contraindications to verapamil, the occurrence of complications, and the frequency of drug failure were determined by chart review. MAIN RESULTS: Patients with contraindications to verapamil experienced a significantly higher incidence of adverse outcomes and drug failures than those without contraindications. The presence of contraindicated rhythms, low pretreatment blood pressure, and signs of congestive heart failure were each specifically associated with an increased risk of adverse sequelae. CONCLUSION: Verapamil should not be administered to patients with contraindications to its use. In this instance, quality assurance process measures correlate with patient outcomes.     

Trainee impact on advanced diagnostic bronchoscopy: An analysis of 607 consecutive procedures in an interventional pulmonary practice

Background and objective: Complications during advanced diagnostic bronchoscopy are rare and include: pneumothorax, bleeding, mediastinitis and lymphadenitis. Increased complications have been demonstrated in patients undergoing routine bronchoscopy procedures performed by trainees. This study aimed to determine the impact of trainees during advanced diagnostic bronchoscopy on procedure time, sedation use and complications. Methods: A retrospective review of a quality improvement database including consecutive pulmonary procedures performed by an interventional pulmonologist (D.R.S.) at the University of Calgary, from 1 July 2007 to 1 April 2011. Results: Six hundred seven (55.2%) of the 1100 procedures involved an advanced diagnostic procedure defined as: endobronchial ultrasound‐guided transbronchial needle aspiration (EBUS‐TBNA), electromagnetic navigation bronchoscopy (ENB) and/or peripheral EBUS. A trainee participated in 512 (84.3%) procedures. A complication occurred in 25 patients (4.1%), with a trend towards increased complication rates in the trainee group (4.7% vs 1.1%, difference 3.6%, P = 0.076). Significant differences were seen when a trainee participated versus when no trainee participated for procedure length (58.32 min vs 37.69 min, difference 20.63 min (95% confidence interval: 19.07–22.19), P = 0.001) and for the dose of propofol (178.3 mg vs 137.1 mg, difference 41.2 mg (95% confidence interval: 19.81–63.38), P = 0.002). Conclusions: In an academic interventional pulmonology practice utilizing the apprenticeship model, trainee participation in advanced diagnostic bronchoscopy increased procedure time, increased the amount of sedation used and resulted in a trend to increased complications. Attempts to modify trainee procedural training to reduce the burden of procedural learning for patients are warranted.     

Management of patients pre-, per- and postcatheter ablation procedures: how to minimize complications?

Catheter ablation using radiofrequency energy has become an accepted and safe treatment of cardiac arrhythmias. Nevertheless, it is important to determine the risk-to-benefit ratio of a specific procedure, especially when treating subjects with non-life-threatening cardiac arrhythmias, such as AV-nodal reentrant tachycardia or atrial fibrillation, and efforts have to be made to reduce the incidence of complications associated with these procedures, which are in the vast majority of cases not directly attributable to RF energy application but rather with obtaining peripheral vascular access or intracardiac catheter manipulation. Although complication rates in atrial fibrillation (AF) ablation have decreased with improvements of the ablation technique and a change of ablation concepts since the introduction of this technique, the risk of complication is still considerable and significantly higher compared to ablation procedures of other supraventricular tachycardia, including potentially life-threatening events. The higher incidence of AF ablation associated complications may be explained by the complex technique, the need for trans-septal puncture or extensive manipulation in the thin walled left atrium, as well as possible adverse effects of sedation. Even "new" complications associated with AF catheter ablation were identified, such as pulmonary vein stenosis or atrio-esophageal fistula formation. This article will review general risks and complications that can occur during RF catheter ablation procedures and conscious sedation with a particular attention on AF ablation procedures.     

Endoscopic biliopancreatic investigations and therapy

The management of most biliopancreatic diseases benefits from endoscopic treatment. Forty years after the first endoscopic cannulation of the ampulla of Vater, the overall effectiveness and safety of endoscopic retrograde cholangiopancreatography (ERCP) can be evaluated using the quality assurance programs that have recently been developed for gastrointestinal endoscopy, including ERCP. Such evaluation does not mean simply reporting therapeutic success and complication rates; rather, it involves a complex analysis of the entire gastrointestinal unit, of the medical practises, and of patient satisfaction. The overall quality of ERCP has been analysed and many quality deficits identified, even in referral centres. Training for such a specialised procedure is difficult and expensive. Competence in ERCP requires as many as 200 ERCP procedures. Quality assurance programs can help to improve the overall quality of endoscopic practise, including training of young endoscopists.     

Simplified scoring system for predicting mortality after percutaneous coronary intervention

OBJECTIVES: We sought to develop a simplified scoring system based on pre-intervention clinical characteristics to predict in-hospital mortality after percutaneous coronary intervention (PCI). BACKGROUND: Percutaneous coronary intervention is associated with variety of complications, including the risk of death. Factors leading to poor outcomes need to be identified. Currently available indexes are cumbersome and therefore seldom used. METHODS: Crude mortality and univariate odds ratios (ORs) for mortality associated with multiple clinical characteristics were calculated for 9,954 patients undergoing PCI at the William Beaumont Hospital during 1996 to 1998. Based on the OR, each factor was assigned a weighted score. Using these scores, a classification was constructed to determine the probability of death after PCI, with classes I through IV representing an increasing probability of procedural mortality. This classification was validated in a separate group of patients.RESULTS: The factors with the highest univariate odds of dying and their scores were: myocardial infarction <14 days = 7; elevated creatinine = 4; multivessel disease = 4; and age >65 years = 3. Classes were created based on the presence of these factors in a given patient. The odds of dying and mortality increased significantly with each class. These results were reproduced in the validation subset. CONCLUSIONS: Preprocedural clinical risk factors have a differential influence on the probability of death after PCI. Risk classification based on these factors can be used to accurately predict the procedural outcome. This simple classification can be used by interventionalists to assist in management decisions, to provide an estimate of procedural risk to the patients and relatives, and for quality assurance.     

Risk factors for complications after performance of ERCP

BACKGROUND: ERCP has become widely available for the diagnosis and treatment of benign and malignant pancreaticobiliary diseases. In this prospective study, the overall complication rate and risk factors for diagnostic and therapeutic ERCP were identified. METHODS: Data were collected prospectively on patient characteristics and endoscopic techniques from 1223 ERCPs performed at a single referral center and entered into a database. Univariate and multivariate analyses were used to identify risk factors for ERCP-associated complications. RESULTS: Of 1223 ERCPs performed, 554 (45.3%) were diagnostic and 667 (54.7%) therapeutic. The overall complication rate was 11.2%. Post-ERCP pancreatitis was the most common (7.2%) and in 93% of cases was self-limiting, requiring only conservative treatment. Bleeding occurred in 10 patients (0.8%) and was related to a therapeutic procedure in all cases. Nine patients had cholangitis develop, most cases being secondary to incomplete drainage. There was one perforation (0.08%). All other complications totaled 1.5%. Variables derived from cannulation technique associated with an increased risk for post-ERCP pancreatitis were precut access papillotomy (20%), multiple cannulation attempts (14.9%), sphincterotome use to achieve cannulation (13.1%), pancreatic duct manipulation (13%), multiple pancreatic injections (12.3%), guidewire use to achieve cannulation (10.2%), and the extent of pancreatic duct opacification (10%). Patient characteristics associated with an increased risk of pancreatitis were sphincter of Oddi dysfunction (21.7%) documented by manometry, previous ERCP-related pancreatitis (19%), and recurrent pancreatitis (16.2%). Pain during the procedure was an important indicator of an increased risk of post-ERCP pancreatitis (27%). Independent risk factors for post-ERCP pancreatitis were identified as a history of recurrent pancreatitis, previous ERCP-related pancreatitis, multiple cannulation attempts, pancreatic brush cytology, and pain during the procedure. CONCLUSIONS: The most frequent ERCP-related complication was pancreatitis, which was mild in the majority of patients. The frequency of post-ERCP pancreatitis was similar for both diagnostic and therapeutic procedures. Bleeding was rare and mostly associated with sphincterotomy. Other complications such as cholangitis and perforation were rare. Specific patient- and technique-related characteristics that can increase the risk of post-ERCP complications were identified.     

Complications associated with pediatric cardiac catheterization

Objectives. The aim of this study was to determine the relative risks of pediatric diagnostic, interventional and electrophysiologic catheterizations.Background. The role of the pediatric catheterization laboratory has evolved in the last decade as a therapeutic modality, although remaining an important tool for anatomic and hemodynamic diagnosis.Methods. A study of 4,952 consecutive pediatric catheterization procedures was undertaken.Results. Patient ages ranged from 1 day to 20 years (median 2.9 years). One or more complications occurred in 436 studies (8.8%) and were classified as major in 102 and minor in 458, with vascular complications (n = 189; 3.8% of procedures) the most common adverse event. Arrhythmic complications (n = 24) were the most common major complication. Death occurred in seven cases (0.14%) as a direct complication of the procedure and was more common in infants (n = 5). Independent risk factors for complications included a young patient age and undergoing an interventional procedure.Conclusions. Complications continue to be associated with pediatric cardiac catheterization. Efforts should be directed to improving equipment for flexibility and size, and finding alternative methods for vascular access. Patient age and interventional studies are risk factors for morbidity and mortality.     

Iatrogenic complications in high-risk, elderly patients.

BACKGROUND--This study explores the quality improvement potential of reviewing care for long-stay, elderly medicine service patients hospitalized for congestive heart failure, acute myocardial infarction, or pneumonia at a large Midwestern teaching hospital. METHODS--Medical records were reviewed for 120 patients aged 65 years or older who were discharged between January 1987 and June 1989, with hospital stays of 15 days or longer. Patients' severity of illness on admission was rated using the Medicare Mortality Predictor System; process quality of care was rated using a structured implicit review form for judging several dimensions of clinical assessment and decision making. Serious complications were coded by etiology and type and judged as possibly or probably preventable. Logistic regression was used to identify risk factors for iatrogenic events; multiple regression was used to assess potential outcome bias in ratings of overall quality of care. RESULTS--Of 120 medical records reviewed, 70 (58.3%) suffered at least one iatrogenic complication. Forty-three patients (35.8%) suffered an iatrogenic complication rated as potentially preventable. Significant predictors of all iatrogenic complications were quality ratings of initial physician assessment, patients' inability to walk unassisted, and low Glasgow Coma Score. For potentially preventable complications, quality ratings for physician documentation of functional status were also significant. Ratings for overall quality of care were not significantly influenced by the mere presence of death or complications. CONCLUSIONS--Iatrogenic complications are likely to be an extremely common experience for elderly medicine service patients with long lengths of stay. A significant portion of these complications may be potentially preventable with closer attention to initial assessment and documentation of patients' functional status.     

Methodological aspects of health-related quality of life measurement and analysis in patients with multiple myeloma

Multiple myeloma (MM) is an incurable but treatment-sensitive cancer. For most patients, this means treatment with multiple lines of anti-myeloma therapy and a life with disease- and treatment-related symptoms and complications. Health-related quality of life (HRQoL) issues play an important role in treatment decision-making. Methodological challenges in longitudinal HRQoL measurements and analyses have been identified, including non-responses (NR) to scheduled questionnaires. Publications were identified for inclusion in a systematic review of longitudinal HRQoL studies in MM, focussing on methodological aspects of HRQoL measurement and analysis. Diversity in timing of HRQoL data collection and applied statistical methods were noted. We observed a high rate of NR, but the impact of NR was investigated in only 8/23 studies. Thus, evidence-based knowledge of HRQoL in patients with MM is compromised. To improve quality of HRQoL results and their implementation in daily practice, future studies should follow established guidelines.     

Safety of dilation in adults with eosinophilic esophagitis

Esophageal dilation is an effective therapy for dysphagia in patients with stenosing eosinophilic esophagitis (EoE). Historically, there have been significant concerns of increased perforation rates when dilating EoE patients. More recent studies suggest that improved techniques and increased awareness have decreased complication rates. The aim of this study was to explore the safety of dilation in our population of EoE patients. A retrospective review of all adult EoE patients enrolled in a registry from 2006 to 2010 was performed. All patients who underwent esophageal dilation during this time period were identified and included in the analysis. Our hospital inpatient/outpatient medical records, radiology reports, and endoscopy reports were searched for evidence of any complication following dilation. Perforation, hemorrhage, and hospitalization were identified as a major complication, and chest pain was considered a minor complication. One hundred and ninety‐six patients (41 years [12]; mean age [standard deviation], 80% white, 85% male) were identified. In this cohort, 54 patients (28%) underwent 66 total dilations (seven patients underwent two dilations, one patient underwent three dilations, and one patient underwent four dilations). Three dilation techniques were used (Maloney [24], Savary [29] and through‐the‐scope [13]). There were no major complications encountered. Chest pain was noted in two patients (4%). There were no endoscopic features (rings, furrows, plaques) associated with any complication. Type of dilator, size of dilator, number of prior dilations, and age of patient were also not associated with complications. Endoscopic dilation using a variety of dilators can be safely performed with minimal complications in patients with EoE.     

Quality assurance in the emergency department

A coordinated approach to quality assurance is essential for managing the complexities of health care in the emergency department. Nearly every activity in the emergency care setting has implications that fall under the quality assurance umbrella. A comprehensive quality assurance program for the emergency department at Michael Reese Hospital was built through a process of defining, further developing, and coordinating existing quality assurance activities. Several new activities were developed to fill identified gaps. The program follows traditional quality assurance concepts for monitoring structure, process, and outcome elements of emergency care. Key principles that are the foundation of the program include active participation by all staff levels (clinical and nonclinical), standardized documentation, and specifically defined review mechanisms.     

Clinically significant radiograph misinterpretations at an emergency medicine residency program

Radiographic misinterpretation rates have been suggested as a quality assurance tool for assessing emergency departments and individual physicians, but have not been defined for emergency medicine residency programs. A study was conducted to define misinterpretation rates for an emergency medicine residency program, compare misinterpretation rates among various radiographic studies, and determine differences with respect to level of training. A total of 12,395 radiographic studies interpreted by emergency physicians during a consecutive 12-month period were entered into a computerized data base as part of our quality assurance program. The radiologist's interpretation was defined as correct. Clinical significance of all discrepancies was determined prospectively by ED faculty. Four hundred seventy-five (3.4%) total errors and 350 (2.8%) clinically significant errors were found. There was a difference in clinically significant misinterpretation rates among the seven most frequently obtained radiograph studies (P less than .0005, chi 2), accounted for by the 9% misinterpretation rates for facial films. No difference (P = .421) was noted among full-time, part-time, third-year, second-year, and "other" physicians. This finding is likely due to faculty review of residents' readings. Evaluation of misinterpretation rates as a quality assurance tool is necessary to determine the role of radiographic quality assurance in emergency medicine resident training. Educational activities should be directed toward radiographic studies with higher-than-average reported misinterpretation rates.     

Antithrombotic therapy in TAVI

Transcatheter aortic valve implantation (TAVI) carries a significant thromboembolic and concomitant bleeding risk, not only during the procedure but also during the periprocedural period. Many issues concerning optimal antithrombotic therapy after TAVI are still under debate. In the present review, we aimed to identify all relevant studies evaluating antithrombotic therapeutic strategies in relation to clinical outcomes after the procedure. Four randomized control trials (RCT) were identified analyzing the post-TAVI antithrombotic strategy with all of them utilizing aspirin lifelong plus clopidogrel for 3?6 months. Seventeen registries have been identified, with a wide variance among them regarding baseline characteristics, while concerning antiplatelet therapy, clopidogrel duration was ranging from 3?12 months. Four non-randomized trials were identified, comparing single vs. dual antiplatelet therapy after TAVI, in respect of investigating thromboembolic outcome events over bleeding complications. Finally, limited data from a single RCT and a retrospective study exist with regards to anticoagulant treatment during the procedure and the optimal antithrombotic therapy when concomitant atrial fibrillation. In conclusion, due to the high risk and frailty of the treated population, antithrombotic therapy after TAVI should be carefully evaluated. Diminishing ischaemic and bleeding complications remains the main challenge in these patients with further studies to be needed in this field.