Risk factors associated with onset of medication-related osteonecrosis of the jaw in patients treated with denosumab.

OBJECTIVES: While risk factors of bisphosphonate (BP) associated osteonecrosis of the jaw have been properly analyzed, studies focusing on risk factors associated with denosumab (DNO) are sparse. The purpose of this study was to identify risk factors influencing the onset of medication-related osteonecrosis of the jaw (MRONJ) in patients receiving antiresorptive treatment (ART) with DNO by comparing patients suffering from MRONJ and patients without MRONJ. Multiple variables were evaluated including the impact of a previous BP intake. MATERIALS AND METHODS: A retrospective single-center cohort study with patients receiving DNO was conducted. One-hundred twenty-eight patients were included and divided into three groups: I (control, n = 40) receiving DNO with absence of MRONJ; group II (Test 1, n = 46), receiving DNO with presence of MRONJ; and group III (Test 2, n = 42) sequentially receiving BP and DNO with presence of MRONJ. Patients' medical history, focusing on the identification of MRONJ risk factors, was collected and evaluated. Parameters were sex, age, smoking habit, alcohol consumption, underlying disease (cancer type, osteoporosis), internal diseases, additional chemo/hormonal therapy, oral inflammation, and trauma. RESULTS: The following risk factors were identified to increase MRONJ onset significantly in patients treated with DNO: chemo/hormonal therapy (p = 0.02), DNO dosage (p < 0.01), breast cancer (p = 0.03), intake of corticosteroids (p = 0.04), hypertension (p = 0.02), diabetes mellitus (p = 0.04), periodontal disease (p = 0.03), apical ostitis (p = 0.02), and denture use (p = 0.02). A medication switch did not affect MRONJ development (p = 0.86). CONCLUSIONS: Malignant diseases, additional chemotherapy, DNO dosage, and oral inflammations as well as diabetes mellitus and hypertension influence MRONJ onset in patients treated with DNO significantly. CLINICAL RELEVANCE: Patients receiving ART with DNO featuring aforementioned risk factors have a higher risk of MRONJ onset. These patients need a sound and regular prophylaxis in order to prevent the onset of MRONJ under DNO treatment.

The Type of Antiresorptive Treatment Influences the Time to Onset and the Surgical Outcome of Medication-Related Osteonecrosis of the Jaw.

PURPOSE: Few data exist focusing on differences in the time to disease onset and the success rates in patients suffering from medication-related osteonecrosis of the jaw (MRONJ) dependent on their different antiresorptive treatment. The purpose of this study was to analyze and compare these variables for patients treated with bisphosphonate (BP) or denosumab (DNO) and for patients who switched the antiresorptive drug (BP/DNO). PATIENTS AND METHODSS: A retrospective single-center cohort study with patients suffering from MRONJ was conducted. The predictor variable was the antiresorptive treatment, the outcome variables were 1) time to onset of MRONJ (time of antiresorptive treatment to MRONJ diagnosis) and 2) treatment success (mucosal integrity 12 months postoperatively). The other variables include data on demographic, underlying disease, MRONJ stage, and trigger events. Cox and logistic regression, Phi-coefficient, Cramer's V, and Kruskal-Wallis tests were applied. RESULTS: One hundred thirty-two patients were included and divided into 3 groups: group I (BP) n = 45 patients, n = 59 lesions; group II (BP/DNO) n = 42 patients, n = 71 lesions; and group III (DNO) n = 45 patients, n = 62 MRONJ lesions. Treatment success and time to onset differed significantly between the groups: success rates in group I BP (84.7%) were significantly lower (P = .04) than in group II BP/DNO (91.5%, P = .12) and group III DNO (90.3%, P = .35). The onset was significantly earlier in group III DNO (median 2.0 years, Q0.25: 1.49, Q0.75: 2.98; confidence interval 95%: 1.93 to 2.83) than in group II BP/DNO (median 4.07 years, Q0.25: 1.64, Q0.75: 6.70; confidence interval 95%: 3.55 to 5.68) and group I BP (median 3.86 years, Q0.25: 1.69, Q0.75: 6.46; confidence interval 95%: 3.43 to 5.87). CONCLUSIONS: The different antiresorptive drugs show distinctive characteristics of time to onset and treatment success with the lowest success rates in the BP group and the earliest onset in the DNO group. The switch of the antiresorptive therapy (BP to DNO) did not influence the outcome variables negatively.

Cardiac surgery residents training in Germany-Status quo and future prospects.

Residency training for specialization in cardiac surgery in Germany recently underwent a series of changes. A new 6-year integrated curriculum has been created that is based on acquisition of specific expertise rather than a rigid time frame. In effect, the training paradigm is one that is competency-based. After compliance with the curricular requirements and successfully completion of an examination, the Federal Medical Chamber grants the status of a licensed specialized physician ("Facharzt") and issues a certificate, which allows for independent clinical practice. There is no recertification during the course of the physicians' professional career. The educational curricula for specialized training are issued by the National Medical Chamber in cooperation with the respective surgical societies and passed by the German Medical Assembly.

Global perspectives on cardiothoracic, cardiovascular, and cardiac surgical training.

OBJECTIVE: Various methods for cardiothoracic, cardiovascular, and cardiac surgical training exist across the globe, with the common goal of producing safe, independent surgeons. A comparative analysis of international training paradigms has not been undertaken, and our goal in doing so was to offer insights into how to best prepare future trainees and ensure the health of our specialty. METHODS: We performed a comparative analysis of available publications offering detailed descriptions of various cardiothoracic, cardiovascular, and cardiac surgical training paradigms. Corresponding authors from previous publications and other international collaborators were also reached directly for further data acquisition. RESULTS: We report various approaches to common challenges surrounding (1) selection of trainees and plans for the future surgical workforce; (2) trainee assessments and certification of competency before independent practice; and (3) challenges related to a changing practice landscape. CONCLUSIONS: Cardiothoracic surgery remains a dynamic and rewarding specialty. Current and future trainees face several challenges that transcend national borders. To foster collaboration and adoption of best practices, we highlight international strengths and weaknesses of various nations in terms of workforce selection, trainee operative experience and assessment, board certification, and preparation for future changes anticipated in cardiothoracic surgery.

Ten-Year Clinical Outcome After Circumferential Pulmonary Vein Isolation Utilizing the Hamburg Approach in Patients With Symptomatic Drug-Refractory Paroxysmal Atrial Fibrillation.

BACKGROUND: Circumferential pulmonary vein isolation (CPVI) is increasingly performed for the treatment of symptomatic drug-refractory paroxysmal atrial fibrillation. Long-term data for >10 years after CPVI are sparse. We investigated the long-term clinical outcome and progression of paroxysmal atrial fibrillation after double-lasso and 3-dimensional electroanatomical mapping-guided CPVI. METHODS AND RESULTS: From 2003 to 2004, 161 patients (mean age: 60±10 years) with symptomatic drug-refractory paroxysmal atrial fibrillation were prospectively enrolled and underwent electroanatomical mapping-guided CPVI. Right-sided and left-sided continuous circular lesions encircling the ipsilateral pulmonary veins were placed with irrigated radiofrequency energy. The procedural end point was the absence of pulmonary vein spikes 30 minutes after CPVI verified by 2 spiral catheters placed within the ipsilateral pulmonary veins (double-lasso technique). Major periprocedural complications occurred in 5 of 161 patients (3.1%). Follow-up was based on outpatient clinic visits, including Holter-ECGs and telephonic interviews. After a single procedure and median follow-up of 129.0 months (interquartile range, 124.7-133.1 months), stable sinus rhythm was present in 53 of 161 (32.9%) patients. Multiprocedural outcome after a mean of 1.73±0.9 procedures and a median follow-up of 123.4 months (interquartile range, 61.0-131.0 months) resulted in stable sinus rhythm in 101 of 161 patients (62.7%). Progression toward persistent atrial fibrillation was observed in 10 of 161 patients (6.2%). CONCLUSION: Ten-year single-procedural outcome of CPVI in patients with paroxysmal atrial fibrillation resulted in stable sinus rhythm in 32.9% and in 62.7% of patients after multiple procedures. The progression rate to persistent AF was remarkably low.