The effect of romosozumab on bone mineral density depending on prior treatment: a prospective, multicentre cohort study in Switzerland.

This multicentre, prospective cohort study measured the effect of romosozumab for 12 months on bone mineral density, taking into account prior therapies. Prior antiresorptive therapy blunted the BMD response to romosozumab, and the duration was correlated with BMD changes at both the lumbar spine and total hip. INTRODUCTION: In Switzerland, romosozumab is administered to high-risk osteoporosis patients. Our study aimed to assess the effect of romosozumab on bone mineral density (BMD), taking into account prior therapies. METHODS: This multicentre, prospective cohort study measured the effect of romosozumab for 12 months in patients in a nationwide Swiss osteoporosis registry. BMD and bone turnover marker (P1NP and CTX) changes were measured and compared between pre-treated and treatment naïve patients. RESULTS: Ninety-nine patients (92 women and 7 men, median age 71 years [65, 76]) were enrolled from January 2021 to December 2023. Among them, 22 had no prior treatment before romosozumab, while 77 had previous therapy (including 23 with a history of prior teriparatide therapy), with a median duration of 6 years [4, 11] of cumulative antiresorptive treatment. Over 12 months, romosozumab led to BMD changes of 10.3% [7.5, 15.5] at the lumbar spine, 3.1% [1.1, 5.8] at the total hip and 3.1% [0.5, 5.3] at the femoral neck, indicating notable variability. Significantly lower BMD responses were observed in pre-treated patients, with the duration of prior antiresorptive therapy inversely associated with BMD increases at the lumbar spine and hip. Other predictors of BMD changes at the total hip included baseline T-scores at the hip, body mass index and baseline CTX level, while the BMD response at the lumbar spine was associated with the lumbar spine T-score at baseline, age and baseline CTX level. CONCLUSION: Prior antiresorptive therapy blunted the BMD response to romosozumab, and the duration was correlated with BMD changes at both the lumbar spine and total hip.

Oncological outcomes after attempted nerve-sparing radical prostatectomy (NSRP) in patients with high-risk prostate cancer are comparable to standard non-NSRP: a longitudinal long-term propensity-matched single-centre study.

OBJECTIVE: To assess the long-term safety of nerve-sparing radical prostatectomy (NSRP) in men with high-risk prostate cancer (PCa) by comparing survival outcomes, disease recurrence, the need for additional therapy, and perioperative outcomes of patients undergoing NSRP to those having non-NSRP. PATIENTS AND METHODS: We included consecutive patients at a single, academic centre who underwent open RP for high-risk PCa, defined as preoperative prostate-specific antigen level of > 20 ng/mL and/or postoperative International Society of Urological Pathology Grade Group 4 or 5 (i.e., Gleason score ≥ 8) and/or ≥pT3 and/or pN1 assessing the RP and lymph node specimen. We calculated a propensity score and used inverse probability of treatment weighting to match baseline characteristics of patients with high-risk PCa who underwent NSRP vs non-NSRP. We analysed oncological outcome as time-to-event and calculated hazard ratios (HRs). RESULTS: A total of 726 patients were included in this analysis of which 84% (n = 609) underwent NSRP. There was no evidence for the positive surgical margin rate being different between the NSRP and non-NSRP groups (47% vs 49%, P = 0.64). Likewise, there was no evidence for the need for postoperative radiotherapy being different in men who underwent NSRP from those who underwent non-NSRP (HR 0.78, 95% confidence interval [CI] 0.53-1.15). NSRP did not impact the risk of any recurrence (HR 0.99, 95% CI 0.73-1.34, P = 0.09) and there was no evidence for survival being different in men who underwent NSRP to those who underwent non-NSRP (HR 0.65, 95% CI 0.39-1.08). There was also no evidence for the cancer-specific survival (HR 0.56, 95% CI 0.29-1.11) or progression-free survival (HR 0.99, 95% CI 0.73-1.34) being different between the groups. CONCLUSION: In patients with high-risk PCa, NSRP can be attempted without compromising long-term oncological outcomes provided a comprehensive assessment of objective (e.g., T Stage) and subjective (e.g., intraoperative appraisal of tissue planes) criteria are conducted.

Comparison of anti-fracture effectiveness of zoledronate, ibandronate and alendronate versus denosumab in a registry-based cohort study.

This registry-based study of 3068 patients with osteoporosis compared the anti-fracture effectiveness of denosumab versus bisphosphonates. Denosumab was associated with significantly greater risk reduction than alendronate or ibandronate for vertebral and any fractures. No difference in fracture risk reduction was found between zoledronate and denosumab. PURPOSE: To analyse the fracture risk of patients with osteoporosis receiving bisphosphonates or denosumab in a real-world setting. METHODS: This registry-based cohort study evaluated patients taking denosumab, bisphosphonates or both sequentially. Fractures were analysed using rates, rate ratios and hazard ratios (HR), including both therapies as time-varying co-variates. Fracture risk hazards were adjusted (aHR) for baseline T-Scores and trabecular bone score (TBS) and were additionally analysed with inverse probability treatment weighting. RESULTS: A total of 3068 patients (89% female; median age at treatment onset, 69 years [63 to 76]) received denosumab (median duration 2.8 years, [2.2 to 4.7]), bisphosphonates (3.4 years, [2.1 to 5.7]) or both sequentially. Thus, 11,078 subject-years were assessed for bisphosphonates (41% alendronate, 36% ibandronate, 23% zoledronate) and 4216 for denosumab. Moreover, 48,375 subject-years were observed before treatment onset, in addition to 2593 years of drug holidays. A total of 1481 vertebral fractures (435 under therapy), 1508 non-vertebral fractures (499 under therapy) and 202 hip fractures (67 under therapy) occurred after age 50. The risks of vertebral, non-vertebral and hip fractures were significantly lower under all bisphosphonates, denosumab and drug holidays than before treatment onset (all p < 0.001). After adjusting for age, baseline T-scores and TBS, denosumab was associated with lower risk than alendronate or ibandronate for vertebral fractures (aHR 0.47 (0.35 to 0.64) and 0.70 [0.53 to 0.91], p < 0.001 and p = 0.009, respectively) and any fractures (aHR 0.62 [0.51 to 0.76] and 0.77 [0.64 to 0.92], p < 0.001 and p = 0.004). With propensity weighting, denosumab was associated with a lower hip fracture risk compared to alendronate (HR 0.54 [0.29 to 0.98], p = 0.044). No difference in fracture risk reduction (vertebral, non-vertebral or hip) was found between zoledronate and denosumab. CONCLUSIONS: When adjusting for disease severity, denosumab was associated with significantly greater risk reduction than alendronate and ibandronate for vertebral fractures. No difference in fracture risk reduction was found between zoledronate and denosumab.

Five-Year Survival of Patients Treated with Minimally Invasive Direct Coronary Artery Bypass (MIDCAB) Compared with the General Swiss Population.

BACKGROUND: To evaluate the midterm follow-up and 5-year survival outcome of the minimally invasive direct coronary artery bypass (MIDCAB) procedure compared with the survival of the general Swiss population. METHODS: Retrospective study on preoperative data, intraoperative data, and postoperative outcome of patients who underwent MIDCAB surgery between June 2010 and February 2019. To assess validity of this surgical therapy, outcomes were compared with survival data of a gender- and age-matched cohort of the general Swiss population taken from the database of the Swiss Federal Statistical Office. RESULTS: A total of 88 patients were included. Median (interquartile range [IQR[) age was 66 (56-75) years, and 27% (n = 24) were female. The median (IQR) length of the in-hospital stay was 7 (6-8) days. No postoperative stroke occurred. The 30-day mortality was 1.1% (n = 1). Reintervention for failed left internal mammary artery was needed in 1.1% (n = 1). The median (IQR) ejection fraction was 58% (47-60) preoperatively and remained stable during follow-up. The median (IQR) follow-up period was 3 (1.1-5.2) years. Five years postoperatively, 83% (confidence interval, 69-91) of the patients were alive, showing an overlap with the range of survival of the matched subcohort of the general Swiss population (range, 84-100%). CONCLUSION: Though suffering from coronary heart disease, patients after MIDCAB show almost equal survival rates as an equivalent subcohort corresponding to the general Swiss population matched on age and gender. Thus, our data show this treatment to be safe and beneficial.

Reducing Postoperative Swelling, Edema, and Ecchymosis after Open Rhinoplasty Using Intranasal Drainage.

Reducing postoperative strain on the patient after rhinoplasty is an important goal for the surgeon. Many strategies are described to reach that goal. One strategy is to remove blood from under the dissected soft tissue envelope by drains, before it can infiltrate the different layers causing ecchymosis, edema, and swelling. In our setting with wide degloving and using drains, we could show a significant reduction in ecchymosis on day 2 and 14 after surgery (p = 0.006 and p = 0.017). We also observed a significant effect for edema and general swelling on day 2 (p = 0.027 and p = 0.004), but this effect did not reach significance for these two parameters on day 14. And although the long-term effect needs to be assessed in the future, we found that using drains in open rhinoplasty with wide degloving is an easily applicable, cheap, and reproducible approach to reduce postoperative ecchymosis, edema, and swelling.

Seminal Vesical Sparing Cystectomy for Bladder Cancer is Feasible with Good Functional Results without Impairing Oncological Outcomes: A Longitudinal Long-Term Propensity-Matched Single Center Study.

PURPOSE: Seminal vesicle-sparing radical cystectomy has been reported to improve short-term functional results without compromising oncological outcomes. However, there is still a lack of data on long-term outcomes after seminal vesicle-sparing radical cystectomy. The aim of this study was to compare oncological and functional outcomes in patients after seminal vesicle-sparing vs nonseminal vesicle-sparing radical cystectomy. MATERIALS AND METHODS: Oncological and functional outcomes of 470 consecutive patients after radical cystectomy and orthotopic ileal reservoir from 2000 to 2017 were evaluated. They were stratified into 6 groups according to nerve-sparing and seminal vesicle-sparing status as attempted during surgery: no sparing at all (55), unilateral nerve sparing (159), bilateral nerve sparing (132), unilateral seminal vesicle-sparing and unilateral nerve sparing (30), unilateral seminal vesicle sparing and bilateral nerve sparing (45), and bilateral seminal vesicle sparing (49) and used propensity modeling to adjust for preoperative differences. RESULTS: Median followup among the entire cohort was 64 months. Among the 6 groups, our analysis showed no difference in local recurrence-free survival (p=0.173). However, progression-free, cancer-specific and overall survival were more favorable in patients with seminal vesicle-sparing radical cystectomy (p <0.001, p=0.006 and p <0.001, respectively). Proportions of patients with erectile function recovery were higher in the seminal vesicle-sparing groups at all time points in all analyses, respectively, with pronounced earlier recovery in patients with bilateral seminal vesicle sparing. Importantly, patients with seminal vesicle sparing were significantly less in need of erectile aids to achieve erection and intercourse. Over the whole period, daytime urinary-continence was significantly better in the seminal vesicle sparing groups (OR 2.64 to 5.21). CONCLUSIONS: In a highly selected group of patients, seminal vesicle sparing radical cystectomy is oncologically safe and results in excellent functional outcomes that are reached at an earlier time point after surgery and remain superior over a longer period of time.

Prolonged antibiotic prophylaxis use in elective orthopaedic surgery - a cross-sectional analysis.

PURPOSE: Surgical antibiotic prophylaxis (SAP) prevents surgical site infections (SSI). In orthopaedic surgery, the use of prolonged SAP (PSAP) has been reported in daily routine, despite guidelines advising against it. Therefore, we asked: What is the proportion of PSAP use, defined as administration of SAP ≥24 h after elective orthopaedic surgery? Are there patient- and surgery-related predictors of PSAP use? METHODS: This cross-sectional analysis investigated 1292 patients who underwent elective orthopaedic surgery including total joint arthroplasties at one Swiss centre between 2015 and 2017. Patient comorbidities, surgical characteristics and occurrence of SSI at 90 days in PSAP group were compared to the SAP group (< 24 h post-operative). RESULTS: PSAP use was 12% (155 of 1292). Patient-related factors associated with PSAP compared to the SAP group included older age (63 vs. 58y; p < 0.001), higher BMI (29 vs. 27 kg/m2; p < 0.001), ASA classification ≥3 (31% vs. 17%; p < 0.001) and lung disease (17% vs. 9%; p = 0.002). Surgery-related factors associated with PSAP were use of prosthetics (62% vs. 45%; p < 0.001), surgery of the knee (65% vs. 25%; p < 0.001), longer surgery duration (87 vs. 68 min; p < 0.001) and presence of drains (90% vs. 65%; p < 0.001). All four SSI occurred in the SAP group (0 vs. 4; p = 1.0). Surgeons administered PSAP with varying frequencies; proportions ranged from 0 to 33%. CONCLUSION: PSAP use and SSI proportions were lower than reported in the literature. Several patient- and surgery-related factors associated with PSAP use were identified and some were potentially modifiable. Also, experienced surgeons seemed to implement differing approaches regarding the duration of SAP administration.

Reduced Permanent Pacemaker Implantation in Patients With Stentless Freedom SOLO Compared With Stented Perimount Magna Aortic Bioprostheses: A Propensity Score Weighted Analysis.

OBJECTIVES: Postoperative permanent pacemaker implantation (PPI) after conventional aortic valve replacement (AVR), due to new-onset severe conduction system disorders, is required in approximately 7% of patients. This study investigated the need for PPI after AVR with conventional stented Perimount Magna compared with the Freedom SOLO (FS) stentless valve (Sorin Group, Saluggia, Italy), now LivaNova plc (London, UK) that uses a strictly supra-annular, subcoronary running suture implantation technique, sparing the vulnerable interleaflet triangles in the region of the septum membranaceum. METHODS: A total of 413 consecutive patients (71.4±9.2 yrs, 178 [43.1%] female) underwent isolated AVR using the stented Perimount Magna (n=264) or the stentless FS (n=149) bioprosthesis. Propensity score weighted analysis was used to account for patient-specific and procedural-specific variables, and to identify the prosthesis-specific need for early postoperative PPI within 30 days of AVR. RESULTS: Twenty (20) patients required PPI, which was associated with longer intensive care unit (2.1±1.7 vs 1.5±3.0 days, p<0.001) and overall hospital stays (13.8±5.2 vs 10.7±5.3 days, p<0.001) compared with no PPI. Propensity weighted logistic regression including cross-clamp times identified that use of the stented Perimount Magna was associated with increased need for PPI, as compared with the FS, with an odds ratio 5.8 (95% CI, 1.09-30.76; p=0.039). CONCLUSIONS: After corrections for all plausible confounders, AVR with the stented Perimount valve was associated with an odds ratio of almost 6 for an increased early postoperative need for pacemaker implantation compared with the FS stentless valve. This finding can be explained by the conventional implantation technique, which is potentially associated with mechanical trauma to the conducting system.

Echocardiographic and Clinical Follow-up After Aortic Valve Neocuspidization Using Autologous Pericardium.

INTRODUCTION: Mid-term data from a single centre showed the safety and durability of aortic valve neocuspidization using autologous pericardium (OZAKI procedure). Since validation data from other centres are missing, aim of this study was to analyze echocardiographic and clinical results of our first patients that were operated with the OZAKI technique. METHODS: Thirty-five patients (24 males, median (IQR) age 72.0 (59.0, 76.0) years) with aortic stenosis (AS; n = 10), aortic insufficiency (AR; n = 13) or a combination of both (AS/AR; n = 12), underwent aortic valve neocuspidization in our institution between September 2015 and May 2017. Echocardiographic follow-up was performed using a standardized examination protocol. RESULTS: Clinical follow-up was completed in 97% of the patients. Median (IQR) follow-up time was 645 (430, 813) days. Mortality rate was 9% (n = 1: aspiration pneumonia; n = 1: unknown; n = 1: anaphylactic shock), and the reoperation rate was 3% (n = 1: endocarditis). No pacemaker implantation was necessary after isolated OZAKI procedures. Echocardiographic follow-up was performed in 83% of the patients (n = 29; median (IQR) time 664 (497, 815) days). Median (IQR) mean and peak gradients were 6 (5,9) mmHg and 12 (8, 17) mmHg. Moderate aortic regurgitation was seen in 2 patients (7%). No severe aortic regurgitation or moderate or severe aortic stenosis occurred within the follow-up period. CONCLUSIONS: The OZAKI procedure is reliable and reoperation due to structural valve deterioration nil within a median 645 days follow-up period. The low rate of moderate aortic regurgitation will be surveilled very closely. Further studies are required to evaluate the significance of this procedure in aortic valve surgery. CLINICAL REGISTRATION NUMBER: ClinicalTrials.gov (ID NCT03677804).

Impact of Modified Frozen Elephant Trunk Procedure on Downstream Aorta Remodeling in Acute Aortic Dissection: CT Scan Follow-Up.

OBJECTIVES: The aim was to evaluate the impact of a modified frozen elephant trunk procedure (mFET) on remodeling of the downstream aorta following acute aortic dissections. METHODS: Over a period of 8 years, 205 patients (mean age 62.6 ± 12.6 years) underwent a mFET (n = 69, 33.7%) or isolated ascending aorta replacement (n = 136, 66.3%) (iAoA). Aortic diameter was assessed at the aortic arch (AoA), at the mid of the thoracic aorta (mThA), at the thoracoabdominal transition (ThAbd) and at the celiac trunk level (AbdA). RESULTS: Mean follow-up was 3.3 ± 2.6 years. In-hospital mortality was 14% (n = 28), 7% in mFET and 17% in the iAoA group (p = 0.08). At the end of the follow-up, overall survival was 84% (95% CI 70-92%) and 75% (65-82%) and freedom from aorta-related reoperation was 100% and 95% (88-98%) for mFET and iAoA, respectively. At iAoA, the average difference in diameter change per year between mFET and iAoA was for total lumen 0 mm (- 0.95 to 0.94 mm, p = 0.99), and for true lumen, it was 1.23 mm (- 0.09 to 2.55 mm) per year, p = 0.067. False lumen demonstrated a decrease in diameter in mFET as compared to iAoA by - 1.43 mm (- 2.75 to - 0.11 mm), p = 0.034. In mFET, at the aortic arch level the total lumen diameter decreased from 30.7 ± 4.8 mm to 30.1 ± 2.5 mm (Δr + 2.90 ± 3.64 mm) and in iAoA it increased from 31.8 ± 4.9 to 34.6 ± 5.9 mm (Δr + 2.88 ± 4.18 mm). CONCLUSION: The mFET procedure provides satisfactory clinical outcome at short term and mid-term and has a positive impact on aorta remodeling, especially at the level of the aortic arch.

Microplegia versus Cardioplexol® in Coronary Artery Bypass Surgery with Minimal Extracorporeal Circulation: Comparison of Two Cardioplegia Concepts.

BACKGROUND: The aim of this study is to compare the combined use of the Myocardial Protection System and our microplegia (Basel Microplegia Protocol) with Cardioplexol® in coronary artery bypass grafting using the minimal extracorporeal circulation. METHODS: The analysis focused on propensity score matched pairs of patients in whom microplegia or Cardioplexol® was used. Primary efficacy endpoints were high-sensitivity cardiac troponin-T on postoperative day 1 and peak values during hospitalization. Furthermore, we assessed creatine kinase and creatinine kinase-myocardial type, as well as safety endpoints. RESULTS: A total of 56 patients who received microplegia and 155 patients who received Cardioplexol® were included. The use of the microplegia was associated with significantly lower geometric mean (confidence interval) peak values of high-sensitivity cardiac troponin-T (233 ng/L [194-280 ng/L] vs. 362 ng/L [315-416 ng/L]; p = 0.001), creatinine kinase (539 U/L [458-633 U/L] vs. 719 U/L [645-801 U/L]; p = 0.011), and creatinine kinase-myocardial type (13.8 µg/L [9.6-19.9 µg/L] vs. 21.6 µg/L [18.9-24.6 µg/L]; p = 0.026), and a shorter length of stay on the intensive care unit (1.5 days [1.2-1.8 days] vs. 1.9 days [1.7-2.1 days]; p = 0.011). Major adverse cardiac and cerebrovascular events occurred with roughly equal frequency (1.8 vs. 5.2%; p = 0.331). CONCLUSIONS: The use of the Basel Microplegia Protocol was associated with lower peak values of high-sensitivity cardiac troponin-T, creatinine kinase, and creatinine kinase-myocardial type and with a shorter length of stay on the intensive care unit, as compared with the use of Cardioplexol® in isolated coronary artery bypass surgery using minimal extracorporeal circulation.

Analysis of Myocardial Ischemia Parameters after Coronary Artery Bypass Grafting with Minimal Extracorporeal Circulation and a Novel Microplegia versus Off-Pump Coronary Artery Bypass Grafting.

BACKGROUND: To compare the performance of our institutionally refined microplegia protocol in conjunction with minimal extracorporeal circulation system (MiECC) with off-pump coronary artery bypass grafting (OPCAB). METHODS: We conducted a single center study including patients undergoing isolated CABG surgery performed either off-pump or on-pump using our refined microplegia protocol in conjunction with MiECC. We used propensity modelling to calculate the inverse probability of treatment weights (IPTW). Primary endpoints were peak values of high-sensitivity cardiac troponin T (hs-cTnT) during hospitalization, and respective first values on the first postoperative day. Endpoint analysis was adjusted for intraoperative variables. RESULTS: After IPTW, we could include 278 patients into our analyses, 153 of which had received OPCAB and 125 of which had received microplegia. Standardized differences indicated that treatment groups were comparable after IPTW. The multivariable quantile regression yielded a nonsignificant median increase of first hs-cTnT by 39 ng/L (95% CI -8 to 87 ng/L, p = 0.11), and of peak hs-cTnT by 35 ng/L (CI -13 to 84, p = 0.11), and of peak hs-cTnT by 35 ng/L (CI -13 to 84, p = 0.11), and of peak hs-cTnT by 35 ng/L (CI -13 to 84, p = 0.11), and of peak hs-cTnT by 35 ng/L (CI -13 to 84. CONCLUSION: The use of our institutionally refined microplegia in conjunction with MiECC was associated with similar results with regard to ischemic injury, expressed in hs-cTnT compared to OPCAB. MACCE was seen equally frequent. ICU discharge was earlier if microplegia was used.

Intra-operative norepinephrine administration and cancer-related outcomes following radical cystectomy for bladder cancer: A cohort study.

BACKGROUND: The impact of anaesthetic techniques on recurrence of cancers is controversial. Elevated plasma catecholamine levels have been implicated in angiogenesis and metastasis in various cancers. OBJECTIVES: To assess the potential association between continuous intra-operative norepinephrine administration and tumour-related outcome in muscle-invasive bladder cancer patients undergoing radical cystectomy with urinary diversion. DESIGN: Retrospective observational cohort study. SETTING: Single tertiary centre, from 2000 to 2017. PATIENTS: We included a consecutive series of 1120 urothelial carcinoma patients undergoing radical cystectomy and urinary diversion, including 411/1120 patients (37%) who received a continuous intra-operative administration of more than 2 µg kg BW h norepinephrine. MAIN OUTCOME MEASURES: The primary outcome was time to tumour recurrence within 5 years after surgery, with death as competing outcome. We used inverse probability of treatment weighting to adjust for imbalances between treatment groups, one having received more than 2 µg kg BW h norepinephrine and the other having received less. We furthermore adjusted for intra-operative variables or years of surgery as sensitivity analyses. RESULTS: The continuous administration of more than 2 µg kg BW h norepinephrine slightly increased tumour recurrence (hazard ratio: 1.47, 95% CI 0.98 to 2.21; P = 0.061). After adjustment for intra-operative variables, and year of surgery hazard ratios were 1.82 (95% CI 1.13 to 2.91, P = 0.013) and 1.85 (95% CI 1.12 to 3.07, P = 0.017), respectively. Overall mortality (with or without tumour recurrence) was not affected by norepinephrine (hazard ratio: 0.84, 95% CI 0.65 to 1.08, P = 0.170). CONCLUSION: Continuous administration of more than 2 µg kg BW h norepinephrine was associated with a slightly increased hazard ratio for tumour recurrence if adjusted for intra-operative variables and year of surgery. This observation could reflect a low potential pro-oncogenic effect of norepinephrine during the intra-operative period. TRIAL REGISTRATION: Not applicable.

Aortic root and ascending aorta dimensions in acute aortic dissection.

OBJECTIVES: Aim of this study was to evaluate ascending aorta and aortic root dimension at acute type A dissection (acute aortic dissection) and to identify demographics elements being allied to the acute event. METHODS: In a period between 2009 and 2017, 225 (n = 71, 32% female, mean age = 63 ± 12 years) patients eligible for analysis of ascending aorta and 223 (n = 70, 31% female, mean age = 63 ± 13 years) of aortic root were included in this study. Aortic diameter was assessed in preoperative computed tomography scan. The predissection diameters were modeled from the diameters obtained at diagnosis, assuming 30% augmentation of the diameter at acute event. RESULTS: The mean diameter of the ascending aorta at dissection was 46 ± 8 mm and the modeled diameter was 32.3 ± 5.7 mm. The diameter of the aortic root at dissection was 42 ± 8 mm and modeled diameter was 29.5 ± 5.6 mm. In multivariate analysis, female gender (p = 0.026) and history of cerebrovascular event (p = 0.001) were associated with acute aortic dissection in small aortic root. Patient age (p < 0.001) and history of inguinal hernia (p = 0.001) in ascending aorta <55 mm correlated with acute aortic dissection. CONCLUSION: Modeling indicates that more than 90% of patients had aortic root and ascending aorta diameter <45 mm. It seems that the aortic diameter expansion over the 55 mm in development of acute aortic dissection is overestimated. Parameters other than aortic size were identified, which may be considered when patients at high risk for dissection were identified.

Angiography Versus Hemodynamics to Predict the Natural History of Coronary Stenoses: Fractional Flow Reserve Versus Angiography in Multivessel Evaluation 2 Substudy.

BACKGROUND: Among patients with documented stable coronary artery disease and in whom no revascularization was performed, we compared the respective values of angiographic diameter stenosis (DS) and fractional flow reserve (FFR) in predicting natural history. METHODS: The present analysis included the 607 patients from the FAME 2 trial (Fractional Flow Reserve Versus Angiography in Multivessel Evaluation 2) in whom no revascularization was performed. FFR varied from 0.20 to 1.00 (average 0.74±0.16), and DS (by quantitative coronary analysis) varied from 8% to 98% (average 53±15). The primary end point, defined as vessel-oriented clinical end point (VOCE) at 2 years, was a composite of prospectively adjudicated cardiac death, vessel-related myocardial infarction, vessel-related urgent, and not urgent revascularization. The stenoses were divided into 4 groups according to FFR and %DS values: positive concordance (FFR≤0.80; DS≥50%), negative concordance (FFR>0.80; DS<50%), positive mismatch (FFR≤0.80; DS<50%), and negative mismatch (FFR>0.80; DS≥50%). RESULTS: The rate of VOCE was highest in the positive concordance group (log rank: X2=80.96; P=0.001) and lowest in the negative concordance group. The rate of VOCE was higher in the positive mismatch group than in the negative mismatch group (hazard ratio, 0.38; 95% confidence interval, 0.21-0.67; P=0.001). There was no significant difference in VOCE between the positive concordance and positive mismatch groups (FFR≤0.80; hazard ratio, 0.77; 95% confidence interval, 0.57-1.09; P=0.149) and no significant difference in rate of VOCE between the negative mismatch and negative concordance groups (FFR>0.80; hazard ratio, 1.89; 95% confidence interval, 0.96-3.74; P=0.067). CONCLUSIONS: In patients with stable coronary disease, physiology (FFR) is a more important determinant of the natural history of coronary stenoses than anatomy (DS). CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT01132495.

Bretschneider (Custodiol®) and St. Thomas 2 Cardioplegia Solution in Mitral Valve Repair via Anterolateral Right Thoracotomy: A Propensity-Modelled Comparison.

BACKGROUND: Single-dose cardioplegia is preferred in minimal invasive mitral valve surgery to maintain the adjustment of the operative site without change of preset visualization. The aim of our study was to compare two widely used crystalloid cardioplegias Bretschneider (Custodiol®) versus St. Thomas 2 in patients who underwent mitral valve repair via small anterolateral right thoracotomy. MATERIAL AND METHODS: From May 2012 until February 2019, 184 isolated mitral valve procedures for mitral valve repair via anterolateral right thoracotomy were performed using Bretschneider (Custodiol®) cardioplegia (n = 123) or St. Thomas (n = 61). Primary efficacy endpoint was peak postoperative high-sensitivity cardiac troponin (hs-cTnT) during hospitalization. Secondary endpoints were peak creatine kinase-muscle brain type (CK-MB) and creatine kinase (CK) as well as safety outcomes. We used inverse probability of treatment weighting (IPTW) in order to adjust for confounding by indication. RESULTS: Peak hs-cTnT was higher after use of Bretschneider (Custodiol®) (geometric mean 716 mg/L, 95% confidence interval (CI) 605-847 mg/L) vs. St. Thomas 2 (561 mg/L, CI 467-674 mg/L, p = 0.047). Peak CK-MB (geometric mean after Bretschneider (Custodiol®): 40 µg/L, CI 35-46, St. Thomas 2: 33 µg/L, CI 27-41, p = 0.295) and CK (geometric mean after Bretschneider (Custodiol®): 1370 U/L, CI 1222-1536, St. Thomas 2: 1152 U/L, CI 972-1366, p = 0.037) showed the same pattern. We did not see any difference with respect to postoperative complications between treatment groups after IPTW. CONCLUSION: Use of St. Thomas 2 cardioplegia was associated with lower postoperative peak levels of all cardiac markers that reflect cardiac ischemia such as hs-cTnT, CK, and CK-MB as compared to Bretschneider (Custodiol®) in propensity-weighted treatment groups.

Clinical implementation of a novel myocardial protection pathway in coronary artery bypass surgery with minimal extracorporeal circulation.

INTRODUCTION: The aim of this study was to report the clinical implementation of the joint use of the Myocardial Protection System (MPS®) and the minimal extracorporeal circulation system (MiECC), in conjunction with an institutionally refined dose/volume-dependent microplegia in coronary artery bypass grafting (CABG). METHODS: Patients with isolated CABG surgery were included. The final protocol to achieve cardioplegic arrest consisted of warm blood cardioplegia with 20 mmol potassium (K), 1.6 g magnesium (Mg) and 40 mg lidocaine per liter (L) blood. We prospectively collected intra- and postoperative data to monitor and validate this novel approach. RESULTS: Eighty patients were operated accordingly. Mean (SD) aortic clamping time and extracorporeal perfusion time were 67.5 (22.6) and 101.1 (31.9) minutes, respectively. Failure to induce cardiac arrest was seen in six patients at the early stage of refinement of the formula. Median (IQR) high -sensitivity cardiac troponin T (hs-cTnT) on the first postoperative day (POD) and peak hs-cTnT were 262.5 ng/L (194.3-405.8) and 265.5 ng/L (194.3-405.8), respectively. Median (IQR) creatine kinase-myocardial type (CK-MB) on POD 1 and peak CK-MB were 14.2 µg/L (10.5-22.7) and 14.2 µg/L (10.7-23.2), respectively. Median (IQR) creatine kinase (CK) on POD 1 and peak CK were 517.5 U/L (389.3-849.8) and 597.5 U/L (455.0-943.0), respectively. No patient died during hospitalization. CONCLUSIONS: The combination of this cardioplegic formula with MPS® and MiECC in CABG was safe and feasible. With the final chemical makeup, cardiac arrest was reliably achieved. Remarkably low postoperative cardiac markers indicate shielded cardiac protection during surgery.

Type II Minimal-Invasive Extracorporeal Circuit for Aortic Valve Replacement: A Randomized Controlled Trial.

Extracorporeal circulation triggers systemic inflammatory response and coagulation disorders which may lead to unfavorable clinical outcome. A type II minimally-invasive extracorporeal circuit (MiECC) is a closed system with markedly reduced artificial surface as compared to conventional extracorporeal circuits (CECC). The aim of this study was to investigate and compare inflammatory responses, complement activation and selected clinical end-points in isolated surgical aortic valve replacement (SAVR) performed with a type II MiECC circuit or a CECC. Fifty patients were prospectively randomized to MiECC or CECC perfusion regimen. Complement activation (sC5b-9), inflammation (IL-6, TNF-α, sCD40-ligand) and activation of the coagulation system (D-dimer, TAT-complex) were determined before operation, at 2 hours and 24 hours after surgery. Clinical end-points included perfusion time, transfusion of allogeneic blood products, postoperative bleeding, sepsis, new onset of atrial fibrillation, stroke and in-hospital mortality. Patient characteristics and baseline plasma markers were similar in both groups. Levels for sC5b-9, TNF-α, sCD40 ligand, TAT-complex and D-dimers were not significantly different between MiECC and CECC at 2 hours and 24 hours after surgery. The IL-6 plasma concentration was lower in the CECC group at 24 hours (P = 0.026, vs. MiECC). Comparisons of the baseline level to values at 2 hours and 24 hours, adjusted for the type of oxygenator and hemoglobin, showed a significantly lower sC5b-9 in MiECC at 2 hours (P = 0.013), but no difference at 24 hours (P=0.990). Compared with CECC, MiECC patients had a shorter perfusion time (P = 0.037) and less transfusion requirements (P = 0.04). In this selected cohort of SAVR patients, the type II MiECC was not inferior to CECC in terms of inflammatory response and complement activation. Thus, MiECC might be an alternative perfusion strategy to conventional.

Freedom SOLO-Associated Thrombocytopaenia is Valve-Dependent and Not Due to In Vitro Pseudothrombocytopaenia.

BACKGROUND: Use of the Freedom SOLO (FS) stentless aortic bioprosthesis is limited by a unique and as yet unexplained severe decrease in postoperative platelet count in the absence of FS-related excess bleeding or thromboembolism. We investigated whether anticoagulant-associated pseudothrombocytopaenia could explain this complication. METHODS: Thirty consecutive patients (mean age 75.4±7.7 years, 11 [36.7%] female) underwent elective aortic valve replacement (AVR) with either the stented bovine Mitroflow (MF, n=18) or the stentless bovine FS (n=12) aortic valve bioprostheses. Serial platelet counts were performed simultaneously with sampling tubes containing tripotassium (K3-)-EDTA, trisodium (Na3)-citrate, or novel alternative magnesium sulfate (MgSO4, ThromboExact™)-based anticoagulant, respectively. RESULTS: Postoperative platelet counts decreased compared with preoperative values in all patients (p<0.001), but were significantly lower in patients receiving FS compared to MF at all measurement time points until the end of observation (day 9). Lowest platelet counts were seen on the first postoperative day for MF (mean reduction: -41.5%) and on the second postoperative day for FS (mean reduction: -59.9%). Postoperative platelet counts did not correlate with any of the anticoagulants, thereby indicating no pseudothrombocytopaenia in the study population. There was no interaction between anticoagulant and type of valve. Only 1% of variance in platelet counts was caused by the anticoagulant, 46% by the day of measurement relative to baseline, and 20% was caused by the type of valve. CONCLUSIONS: The platelet-lowering effect in patients receiving the FS is valve-dependent and is not caused by systemic preanalytical (laboratory) measurement error such as anticoagulant-dependent pseudothrombocytaemia, particularly with EDTA and citrate.