Postoperative Complications After Neoadjuvant Chemotherapy Versus Upfront Surgery in Gastric Adenocarcinoma: A Population-Based Nationwide Study in Finland.

BACKGROUND: To date, no large population-based studies have compared complications and short-term outcomes between neoadjuvant chemotherapy and upfront surgery in gastric cancer. More nationwide studies with standardized reporting on complications are needed to enable international comparison between studies. This study aimed to compare postoperative complications between neoadjuvant therapy and upfront surgery after gastrectomy for gastric adenocarcinoma in a population-based setting. METHODS: This population-based study based on the Finnish National Esophago-Gastric Cancer Cohort included all patients 18 years of age or older undergoing gastrectomy for gastric adenocarcinoma in Finland during 2005-2016. Logistic regression provided odds ratios (ORs) with 95% confidence intervals (CIs), both crude and adjusted for key confounders. Different types of complications were graded based on the Esophagectomy Complications Consensus Group definitions, and major complications were assessed by the Clavien-Dindo scale. RESULTS: This study analyzed 769 patients. Neoadjuvant chemotherapy did not increase major postoperative complications after gastrectomy for gastric cancer compared with upfront surgery (OR, 1.12; 95% CI 0.81-1.56). Furthermore, it did not increase pneumonia, anastomotic complications, wound complications, or other complications. CONCLUSIONS: Neoadjuvant therapy is not associated with increased postoperative complications, reoperations, or short-term mortality compared with upfront surgery in gastric adenocarcinoma.

Comparison of Postoperative Complications After Gastrectomy for Gastric Cancer with Antecolic Versus Retrocolic Reconstruction: A Population-Based Study.

BACKGROUND: The purpose of this study was to examine the rates of 90-day anastomotic complications and other postoperative complications after total or partial gastrectomy with antecolic versus retrocolic reconstruction in a population-based setting. METHODS: This population-based nationwide retrospective cohort study included all patients undergoing total or partial gastrectomy for gastric adenocarcinoma in Finland in 2005-2016, with follow-up until 31 December 2019. Logistic regression provided odds ratios (ORs) with 95% confidence intervals (CIs) of 90-day mortality. Results were adjusted for age, sex, year of the surgery, comorbidities, tumor locations, pathological stage, and neoadjuvant therapy. RESULTS: A total of 2063 patients having gastrectomy with antecolic (n = 814) or retrocolic (n = 1249) reconstruction were identified from the registries. The anastomotic complication rate was 3.8% with antecolic reconstruction and 5.0% with retrocolic reconstruction. Antecolic reconstruction was not associated with a higher risk of anastomotic complications compared with retrocolic reconstruction in the adjusted analysis (OR 0.69, 95% CI 0.44-1.09) of the whole cohort or in the predefined subgroups. The reoperation rate was 8.2% with antecolic reconstruction and 7.7% with retrocolic reconstruction, without statistical significance. In subgroup analysis of total gastrectomy patients, the risk of major complications was lower with antecolic reconstruction compared with retrocolic reconstruction (OR 0.62, 95% CI 0.45-0.86). CONCLUSIONS: The rate of anastomotic complications did not differ after antecolic versus retrocolic reconstruction after total or partial gastrectomy. In total gastrectomies, the risk of major complications was lower after antecolic compared with retrocolic reconstruction.

Five-year Survival after McKeown Compared to Ivor-Lewis Esophagectomy for Esophageal Cancer: A Population-based Nationwide Study in Finland.

OBJECTIVE: The aim of study was to compare overall 5-year survival of esophageal cancer patients undergoing transthoracic esophagectomy with either neck or intrathoracic anastomosis, that is, McKeown and Ivor-Lewis esophagectomy. BACKGROUND: No national studies comparing long-term survival after McKeown and ivor-Lewis esophagectomies in the West exist. METHODS: This population-based nationwide study included all curatively intended transthoracic esophagectomies for esophageal adenocarcinoma or squamous cell carcinoma in Finland in 1987 to 2016, with follow-up until December 31, 2019. Cox proportional hazard models provided hazard ratios (HR) with 95% confidence intervals (ci) of all-cause 5-year mortality. The results were adjusted for age, sex, year of the operation, comorbidities, histology, stage, and neoadjuvant treatment. Adjusted model 2 included also tumor location and lymph node yield. RESULTS: A total of 990 patients underwent McKeown (n = 278) or Ivor-Lewis (n = 712) esophagectomy The observed overall 5-year survival was 43.1% after McKeown, and 45.9% after Ivor-Lewis esophagectomy. McKeown esophagectomy was not associated with the overall 5-year mortality (adjusted HR 1.11, 95% CI: 0.89-1.38), compared to Ivor-Lewis esophagectomy. Additional adjustment for tumor location and lymphadenectomy further attenuated the point estimate (HR 1.06, 95% CI: 0.85-1.33). Surgical approach was not associated with 90-day mortality rate (adjusted HR 1.15, 95% CI: 0.67-1.97). CONCLUSIONS: This population-based nationwide study suggests that overall 5-year survival or 90-day survival with McKeown and Ivor-Lewis esopha-gectomy for esophageal cancer are comparable.

Long-Term Survival After Transhiatal Versus Transthoracic Esophagectomy: A Population-Based Nationwide Study in Finland.

BACKGROUND: No population-based studies comparing long-term survival after transhiatal esophagectomy (THE) and transthoracic esophagectomy (TTE) exist. This study aimed to compare the 5-year survival of esophageal cancer patients undergoing THE or TTE in a population-based nationwide setting. METHODS: This study included all curatively intended THE and TTE for esophageal cancer in Finland during 1987-2016, with follow-up evaluation until 31 December 2019. Cox proportional hazard models provided hazard ratios (HRs) with 95% confidence intervals (CIs) of 5-year and 90-day mortality. The results were adjusted for age, sex, year of operation, comorbidities, histology, neoadjuvant treatment, and pathologic stage. RESULTS: A total of 1338 patients underwent THE (n = 323) or TTE (n = 1015). The observed 5-year survival rate was 39.3% after THE and 45.0% after TTE (p = 0.072). In adjusted model 1, THE was not associated with greater 5-year mortality (HR 0.99; 95% CI 0.82-1.20) than TTE. In adjusted model 2, including T stage instead of pathologic stage, the 5-year mortality hazard rates after THE (HR 0.87, 95% CI 0.72-1.05) and TTE were comparable. The 90-day mortality rate for THE was higher than for TTE (adjusted HR 0.72; 95% CI 0.45-1.14). In subgroup analyses, no differences between THE and TTE were observed in Siewert II gastroesophageal junction cancers, esophageal cancers, or pN0 tumors, nor in the comparison of THE and TTE with two-field lymphadenectomy. The sensitivity analysis, including patients with missing patient records, who underwent surgery during 1996-2016 mirrored the main analysis. CONCLUSIONS: This Finnish population-based nationwide study suggests no difference in 5-year or 90-day mortality after THE and TTE for esophageal cancer.

Perioperative Bleeding Requiring Blood Transfusions is Associated With Increased Risk of Stroke After Transcatheter and Surgical Aortic Valve Replacement.

OBJECTIVES: The authors aimed to investigate the impact of severe bleeding and use of red blood cell (RBC) transfusion on the development of postoperative stroke after surgical (SAVR) and transcatheter aortic valve replacement (TAVR), taken from the FinnValve registry. DESIGN: Nationwide, retrospective observational study. SETTING: Five Finnish university hospitals participated in the registry. PARTICIPANTS: A total of 6,463 patients who underwent SAVR (n = 4,333) or TAVR (n = 2,130). INTERVENTIONS: Patients who underwent TAVR or SAVR with a bioprosthesis with or without coronary revascularization. MEASUREMENTS AND MAIN RESULTS: The incidence of postoperative stroke after SAVR was 3.8%. In multivariate analysis, the number of transfused RBC units (odds ratio [OR], 1.098; 95% confidence interval [CI], 1.064-1.133) was one of the independent predictors of postoperative stroke. The incidence of stroke increased, along with the severity of perioperative bleeding, according to the European Coronary Artery Bypass Grafting (E-CABG) bleeding grades were as follows: grade 0, 2.2% (reference group); grade 1, 3.4% (adjusted OR, 1.841; 95% CI, 1.105-3.066); grade 2, 5.5% (adjusted OR, 3.282; 95% CI, 1.948-5.529); and grade 3, 14.8% (adjusted OR, 7.103; 95% CI, 3.612-13.966). The incidence of postoperative stroke after TAVR was 2.5%. The number of transfused RBC units was an independent predictor of stroke after TAVR (adjusted OR, 1.155; 95% CI, 1.058-1.261). The incidence of postoperative stroke increased, along with the severity of perioperative bleeding, as stratified by the E-CABG bleeding grades: E-CABG grade 0, 1.7%; grade 1, 5.3% (adjusted OR, 1.270; 95% CI, 0.532-3.035); grade 2, 10.0% (adjusted OR, 2.898; 95% CI, 1.101-7.627); and grade 3, 30.0% (adjusted OR, 10.706; 95% CI, 2.389-47.987). CONCLUSIONS: Perioperative bleeding requiring RBC transfusion and/or reoperation for intrathoracic bleeding is associated with an increased risk of postoperative stroke after SAVR and TAVR. Patient blood management and meticulous preprocedural planning and operative technique aiming to avoid significant perioperative bleeding may reduce the risk of cerebrovascular complications.

Early and late pace-maker implantation after transcatheter and surgical aortic valve replacement.

BACKGROUND: Conduction defects requiring permanent pacemaker (PPM) implantation are frequent complications occurring after surgical (SAVR) and transcatheter aortic valve replacement (TAVR). METHODS: Patients who underwent TAVR or SAVR with a bioprosthesis from the nationwide FinnValve registry were the subjects of this study. Patients with prior PPM, who received a sutureless prosthesis, or required cardiac resynchronization therapy or implantable cardioverter defibrillator were excluded from this analysis. RESULTS: Four thousand and ten patients underwent SAVR and 1,897 underwent TAVR. TAVR had an increased risk of PPM implantation at 30-day (10.1% vs. 3.5%, unadjusted OR 3.11, 95%CI 2.56-3.87) and 5-year (15.7% vs. 8.6%, unadjusted SHR, 2.12, 95%CI 1.81-2.48) compared to SAVR. PPM implantation within 30 days from the index procedure did not increase the risk of 5-year mortality after either SAVR or TAVR. Among 1,042 propensity score matched pairs, TAVR had an increased risk of PPM implantation at 30-day (9.9% vs. 4.7%, p < .0001) and 5-year (14.7% vs. 11.4%, p = .001), but late (>30 days) PPM implantation at 5-year (4.7% vs. 6.9% SHR 0.72, 95%CI 0.47-1.10) was comparable to SAVR. The types of prosthesis had an impact on 30-day PPM implantation after TAVR, but not on late (>30 days) PPM implantation. CONCLUSIONS: Although the risk of 30-day PPM implantation is higher after TAVR compared to SAVR, late (>30 days) PPM implantation was comparable with these treatment methods. PPM implantation within 30 days did not affect late survival.

Impact of minimal invasive extracorporeal circulation on atrial fibrillation after coronary artery bypass surgery.

Postoperative atrial fibrillation (POAF) is the most common arrhythmia after cardiac surgery with an incidence between 15% and 50% and pathophysiology not fully known. By choosing the method of extracorporeal circulation with focus on the reduction of systemic inflammatory response, one can potentially decrease the risk of POAF. In this prospective, randomized trial, we compared minimal invasive extracorporeal circulation (MiECC) with conventional extracorporeal circulation (CECC) in the prevention of POAF after coronary artery bypass surgery (CABG). A total of 240 patients who were scheduled for their first on-pump CABG, were randomized to MiECC or CECC. The primary outcome measure was the incidence of first POAF during the first 84 hours after surgery. POAF occurred in 42/120 (35.0%) MiECC patients and 43/120 (35.8%) CECC patients with nonsignificant difference between the groups (OR 1.043, 95% CI 0.591-1.843, P = .884). The first postoperative creatine kinase-MB mass (CK-MBm) value was lower in the MiECC group, 13.95 [10.5-16.7] (median [IQR]) than in the CECC group, 15.30 [11.4-18.9] (P = .036), whereas the use of perioperative dobutamine was higher in the MiECC group, 18/120 (15.0%), than in the CECC group 8/120 (6.7%) (P = .038). The incidence of a stroke, perioperative myocardial infarction, and resternotomy caused by bleeding did not differ in the MiECC and CECC groups. Age (OR 1.08, 95% CI 1.04-1.13, P = .000) and peak postoperative CK-MBm (OR 1.57, 95% CI 1.06-2.37, P = .026) were independent predictors of POAF. MiECC compared to CECC was not effective in reducing the incidence of POAF in patients undergoing CABG.

Blood Transfusion and Outcome After Transfemoral Transcatheter Aortic Valve Replacement.

OBJECTIVE: To investigate the prognostic impact of red blood cell (RBC) transfusion on the outcome after transfemoral transcatheter aortic valve replacement (TAVR). DESIGN: Nationwide, retrospective multicenter study. SETTING: Five University Hospitals. PARTICIPANTS: The nationwide FinnValve registry included data from 2,130 patients who underwent TAVR for aortic stenosis from 2008 to 2017. After excluding patients who underwent TAVR through nontransfemoral accesses, 1,818 patients were selected for this analysis. INTERVENTION: TAVR with or without coronary revascularization. MEASUREMENTS AND MAIN RESULTS: RBCs were transfused in 293 patients (16.1%). Time-trend analysis showed that the rates of RBC transfusion decreased significantly from 27.5% in 2012 to 10.0% in 2017 (p < 0.0001). Among 281 propensity score matched pairs, RBC transfusion was associated with higher 30-day mortality (7.1% v 0%, p < 0.0001), late mortality (at 5-year, 59.1% v 43.3%, p = 0.008), as well as increased risk of acute kidney injury (17.0% v 4.4%, p < 0.0001), renal replacement therapy (3.6% v 0.4, p < 0.0001) and prolonged hospital stay (mean, 8.5 v 4.7 days, p < 0.0001) compared with patients who did not receive blood transfusion. In the overall series, the risk of adverse events increased significantly with the increasing amount of transfused RBC units and when operation for excessive bleeding was necessary. Consistently with these findings, postoperative hemoglobin drop and nadir level were associated with higher early and late mortality. CONCLUSIONS: Patients who received blood transfusion after TAVR had an increased risk of early and late adverse events. These adverse effects were particularly evident with increasing amount of RBC transfusion and operations for excessive bleeding.

Postoperative delayed emptying after total, subtotal, or distal gastrectomy for gastric cancer: a population-based study.

BACKGROUND: This study aimed to examine the rate of delayed emptying and other 90-day postoperative complications after total, subtotal, and distal gastrectomies for gastric adenocarcinoma in a population-based setting. METHODS: This study included all patients who underwent total, subtotal, or distal gastrectomy for gastric cancer in Finland in 2005-2016, with follow-up until December 31, 2019. Logistic regression provided the odds ratios with 95% CIs of 90-day mortality. The results were adjusted for age, sex, year of surgery, comorbidities, pathologic stage, and neoadjuvant therapy. RESULTS: A total of 2058 patients underwent total (n = 1227), subtotal (n = 450), or distal (n = 381) gastrectomy. In the total, subtotal, and distal gastrectomy groups, the rates of 90-day delayed emptying were 1.7%, 1.3%, and 2.1% in the whole cohort and 1.6%, 1.8%, and 3.5% in the subgroup analysis of R0 resections, respectively. The resection type was not associated with the risk of delayed emptying. Subtotal gastrectomy was associated with a lower risk of major complications and reoperations, whereas distal gastrectomy was associated with a lower risk of anastomotic complications. CONCLUSION: The extent of resection did not affect delayed emptying, whereas fewer postoperative complications were observed after subtotal or distal gastrectomy than after total gastrectomy.

Stapled vs handsewn anastomosis and anastomotic leaks in gastric cancer surgery-a population-based nationwide study in Finland.

BACKGROUND: There is a lack of evidence regarding anastomotic technique and postoperative complications in gastric cancer surgery. This study aimed to evaluate whether there are differences between stapled and handsewn anastomosis and anastomotic leaks. METHODS: This was a population-based, retrospective, nationwide cohort study in Finland using the Finnish National Esophago-Gastric Cancer Cohort. Patients undergoing gastrectomy with available postoperative complication data were included. Logistic regression analysis was used to calculate the odds ratios with 95% CIs, adjusted for calendar period of surgery, age at surgery, sex, comorbidity, tumor stage, neoadjuvant therapy, minimally invasive surgery, type of gastrectomy, radical resection, and type of anastomosis. RESULTS: Of the 2164 patients, 472 of all patients (21.8%) had handsewn anastomosis and 1692 of all patients (78.2%) had stapled anastomosis. In the unadjusted analysis, anastomotic leaks were significantly lower in the handsewn group (hazard ratio [HR], 0.42; 95% CI, 0.22-0.79) than the stapled group, but after adjustment for known prognostic factors, this association was no longer significant (HR, 0.57; 95% CI, 0.27-1.21). In the analysis stratified by gastrectomy type (distal or total), no differences in anastomotic leaks were observed between anastomotic techniques. CONCLUSION: In this population-based nationwide study, anastomotic technique (stapled or handsewn) was not associated with anastomotic leaks in any, distal or total, gastrectomy.

Twenty years' experience of type B aortic dissections: a population-based national registry study from Finland.

OBJECTIVES: The objective of this study was to investigate the incidence, treatment and survival of Stanford type B aortic dissection (BTAD) during 20 years in the Finnish population. METHODS: Data collection was made from the Nationwide Care Register for Health Care, Finnish National Institute for Health and Welfare. All patients over 15 years of age with BTAD from 2000 to 2019 were included in the study. A data search of the Registry of Death Cause (Statistic Finland) was carried out to identify the date and cause of death. RESULTS: There were 1742 cases of BTAD during the study period. BTAD represented 45.6% of all aortic dissections leading to hospital admission. Incidence for BTAD was 1.62 per 100 000 inhabitants per year. The median survival was 12.7 years [95% confidence interval (CI) 9.63-14.7], 12.4 years (95% CI 10.5-14.4) and 8.6 years (95% CI 7.5-9.7) for patients treated with thoracic endovascular aortic repair (TEVAR), surgery and medical treatment (MT), respectively. Survival was significantly better after TEVAR and surgery, compared to MT only (P < 0.001). Age-adjusted survival was significantly better after TEVAR compared to patients treated with MT or surgery (hazard ratio 0.578, 95% CI 0.420-0.794, P < 0.001). Aortic-related death was the most common cause of death in all groups (41%). CONCLUSIONS: The incidence of BTAD seems to be similar in the Finnish population compared to other populational studies. Patients treated with TEVAR had significantly better survival compared to other patients. A high risk for late aortic-related death should be recognized in patients with BTAD.

Preoperative Esophageal Stenting and 5-Year Survival in Patients Undergoing Esophagectomy for Esophageal Cancer: a Population-Based Nationwide Study from Finland.

BACKGROUND: Preoperative esophageal stenting is proposed to have a negative effect on outcomes. The aim was to compare a 5-year survival in patients undergoing esophagectomy for esophageal cancer with and without preoperative esophageal stent in a population-based nationwide cohort from Finland. The secondary outcome was 90-day mortality. METHODS: This study included curatively intended esophagectomies for esophageal cancer in Finland between 1999 and 2016, with follow-up until December 31, 2019. Cox proportional hazards models provided hazard ratios (HRs) with 95% confidence intervals (CIs) of overall 5-year and 90-day mortality. Model 1 was adjusted for age, sex, year of the surgery, comorbidities, histology, pathological stage, and neoadjuvant therapy. Model 2 included also albumin level and BMI. RESULT: Of 1064 patients, a total of 134 patients underwent preoperative stenting and 930 did not. In both adjusted models 1 and 2, higher 5-year mortality was seen in patients with preoperative stent with HRs of 1.29 (95% CI 1.00-1.65) and 1.25 (95% CI 0.97-1.62), respectively, compared to no stenting. The adjusted HR of 90-day mortality was 2.49 (95% CI 1.27-4.87) in model 1 and 2.49 (95% CI 1.25-4.99) in model 2. When including only neoadjuvant-treated patients, those with preoperative stent had a 5-year survival of 39.2% compared to 46.4% without stent (adjusted HR 1.34, 95% CI 1.00-1.80), and a 90-day mortality rate of 8.5% and 2.5% (adjusted HR 3.99, 95% CI 1.51-10.50). DISCUSSION: This nationwide study reports worse 5-year and 90-day outcomes in patients with preoperative esophageal stent. Since residual confounding remains possible, observed difference could be only an association rather than the cause.

Population-based nationwide incidence of complications after gastrectomy for gastric adenocarcinoma in Finland.

BACKGROUND: The incidence of postoperative complications after gastrectomy for gastric cancer is not well known. More population-based studies using established complication classifications are needed for international comparison. The aim of this study was to evaluate the population-based incidence of postoperative complications after gastrectomy for gastric cancer. METHODS: This population-based study based on the Finnish National Esophago-Gastric Cancer Cohort included all patients at least 18 years of age undergoing gastrectomy for gastric adenocarcinoma in Finland during 2005-2016. The occurrence of complications 30 and 90 days after surgery was graded based on the Esophagectomy Complications Consensus Group definitions and the severity of complications was assessed using the Clavien-Dindo scale. RESULTS: This study included a total of 2196 patients. Postoperative complications occurred in 906 (41.3 per cent) of patients during 30 days after surgery and in 946 (43.1 per cent) during 90 days after surgery. Clavien-Dindo grade III or higher complications occurred in 375 (17.1 per cent) of patients. The most common complications 90 days after surgery by Esophagectomy Complications Consensus Group upper-level categories were gastrointestinal (n = 438; 19.9 per cent), including anastomotic leak, infectious (n = 377; 17.2 per cent) and pulmonary (n = 335; 15.3 per cent) complications. Postoperative mortality rate was occurred in 72 (3.3 per cent) patients within 30 days and in 161 (7.3 per cent) patients within 90 days after surgery. The median duration of postoperative hospital stay was 9 days (interquartile range 4-14). CONCLUSIONS: Postoperative complications are common across all types of gastrectomy and the majority occur during the first 30 postoperative days. This study informs the patients and caregivers of the expected outcomes of gastrectomy.

A modified candy-plug technique to occlude false lumen in aortic dissection.

PURPOSE: Aim of this technical note article is to introduce a modified, novel way to custom create a candy-plug (CP) device to endovascularly occlude false lumen. The technique is illustrated by a patient case with significant backflow to false lumen (FL). The patient had already undergone surgical repair of the ascending aorta, aortic arch and subsequent TEVAR procedure down to the ostium of the celiac trunk because of type A aortic dissection, but the descending thoracic aorta continued to dilate due to backflow to the FL from an uncovered tear at the level of the renal arteries. MATERIALS AND METHODS: We modified a Gore Excluder 36-45 mm aortic extender (W. L. Gore & Associates, Inc. Flagstaff, USA) endoprosthesis into a CP device that was subsequently positioned under local anesthesia into the FL of the distal descending thoracic aorta. RESULTS: In 1 month control the backflow to false lumen had ceased and the aorta had decreased in diameter from 69 to 66 mm, FL from 37 to 34 mm, true lumen (TL) remained the same 32 mm. CONCLUSION: We describe a modified, effective candy-plug technique to occlude retrograde false lumen filling in aortic dissection.

Prevention of Atrial Fibrillation After Cardiac Surgery: A Review of Literature and Comparison of Different Treatment Modalities.

Atrial fibrillation is the most common arrhythmia to occur after cardiac surgery, with an incidence of 10% to 50%. It is associated with postoperative complications including increased risk of stroke, prolonged hospital stays and increased costs. Despite new insights into the mechanisms of atrial fibrillation, no specific etiologic factor has been identified as the sole perpetrator of the arrhythmia. Current evidence suggests that the pathophysiology of atrial fibrillation in general, as well as after cardiac surgery, is multifactorial. Studies have also shown that new-onset postoperative atrial fibrillation following cardiac surgery is associated with a higher risk of short-term and long-term mortality. Furthermore, it has been demonstrated that prophylactic medical therapy decreases the incidence of postoperative atrial fibrillation after cardiac surgery. Of note, the incidence of postoperative atrial fibrillation has not changed during the last decades despite the numerous preventive strategies and operative techniques proposed, although the perioperative and postoperative care of cardiac patients as such has improved.

Transcatheter and surgical aortic valve replacement in patients with left ventricular dysfunction.

BACKGROUND: Patients with severe aortic stenosis and left ventricular systolic dysfunction have a poor prognosis, and this may result in inferior survival also after aortic valve replacement. The outcomes of transcatheter and surgical aortic valve replacement were investigated in this comparative analysis. METHODS: The retrospective nationwide FinnValve registry included data on patients who underwent transcatheter or surgical aortic valve replacement with a bioprosthesis for severe aortic stenosis. Propensity score matching was performed to adjust the outcomes for baseline covariates of patients with reduced (≤ 50%) left ventricular ejection fraction. RESULTS: Within the unselected, consecutive 6463 patients included in the registry, the prevalence of reduced ejection fraction was 20.8% (876 patients) in the surgical cohort and 27.7% (452 patients) in the transcatheter cohort. Reduced left ventricular ejection fraction was associated with decreased survival (adjusted hazards ratio 1.215, 95%CI 1.067-1.385) after a mean follow-up of 3.6 years. Among 255 propensity score matched pairs, 30-day mortality was 3.1% after transcatheter and 7.8% after surgical intervention (p = 0.038). One-year and 4-year survival were 87.5% and 65.9% after transcatheter intervention and 83.9% and 69.6% after surgical intervention (restricted mean survival time ratio, 1.002, 95%CI 0.929-1.080, p = 0.964), respectively. CONCLUSIONS: Reduced left ventricular ejection fraction was associated with increased morbidity and mortality after surgical and transcatheter aortic valve replacement. Thirty-day mortality was higher after surgery, but intermediate-term survival was comparable to transcatheter intervention. Trial registration The FinnValve registry ClinicalTrials.gov Identifier: NCT03385915.

Combined Mitral and Aortic Valve Surgery: 17-year Experience in a Single Center.

BACKGROUND AND OBJECTIVE: It is not uncommon that patients requiring valve surgery have several simultaneous valvular dysfunctions. Combined aortic and mitral valve surgery is the most common form of double-valve surgery. The aim of this study was to analyze and present the outcomes of simultaneous aortic and mitral valve surgery in a single center in a real-life setting. METHODS: The study population consisted of 150 patients operated in the Kuopio University Hospital from 2004 to 2020. All patients undergoing concomitant mitral and aortic valve surgery were included. Four groups were formed based on either the etiology or pathophysiology of the valvular dysfunction. The most common combination was mitral regurgitation with aortic regurgitation (n = 72, 48%), followed by mitral regurgitation with aortic stenosis (n = 37, 25%), endocarditis (n = 29, 19%), and mitral stenosis with aortic regurgitation or stenosis (n = 12, 8%). Concomitant coronary artery revascularization was performed in 37 (25%) patients and tricuspid valve repair in 26 (17%) patients. RESULTS: Operative mortality was 2% and 30-day mortality was 7%. Overall survival was 86%, 78%, and 61% in 3, 5, and 10 years, respectively. Patients with endocarditis were significantly more morbid, and more often than other patients had to undergo an emergency operation. There were no significant differences between the groups in terms of early and late survival. In the overall cohort, the EuroSCORE II value, increased pulmonary artery pressure, decreased glomerular filtration, and length of the operation displayed a negative correlation with survival. CONCLUSIONS: Despite the challenging nature of multivalvular heart disease, surgery is a safe method of treatment with good short- and long-term outcomes.

Intranasal Fentanyl for Intervention-Associated Breakthrough Pain After Cardiac Surgery.

BACKGROUND: Cardiac bypass surgery patients have early postoperative interventions that elicit breakthrough pain. We evaluated the use of intranasal fentanyl for breakthrough pain management in these patients. METHODS: Multimodal analgesia (paracetamol 1 g three times a day, oxycodone 2-3 mg boluses with a patient-controlled intravenous pump) was used in 16 patients (age 49-70 years, weight 59-129 kg) after cardiac bypass surgery. Intranasal fentanyl 100 µg or 200 µg was used to manage breakthrough pain on the first and third postoperative mornings in a randomised order. Blood samples were collected for up to 3 h after fentanyl administration, pain was assessed with a numeric rating scale of 0-10. Plasma fentanyl concentration was assayed using liquid chromatography-mass spectrometry. Body composition was measured with a bioelectrical impedance device. RESULTS: Bioavailability of intranasal fentanyl was high (77%), absorption half-time short (< 2 min) and an analgesic plasma concentration ≥ 0.5 ng/mL was achieved in 31 of 32 administrations. Fentanyl exposure correlated inversely with skeletal muscle mass and total body water. Fentanyl analgesia was effective both on the first postoperative morning with chest pleural tube removal and during physiotherapy on the third postoperative morning. The median time of subsequent oxycodone administration was 1.1 h after intranasal fentanyl 100 µg and 2.1 h after intranasal fentanyl 200 µg, despite similar oxycodone concentrations (median 13.8, range 5.2-35 ng/mL) in both fentanyl dose groups. CONCLUSIONS: Intranasal fentanyl 100 µg provided rapid-onset analgesia within 10 min and is an appropriate starting dose for incidental breakthrough pain in the first 3 postoperative days after cardiac bypass surgery. CLINICAL TRIAL REGISTRATION: EudraCT Number: 2018-001280-22.

Transcatheter and surgical aortic valve replacement in patients with bicuspid aortic valve.

OBJECTIVES: To compare the outcomes after surgical (SAVR) and transcatheter aortic valve replacement (TAVR) for severe stenosis of bicuspid aortic valve (BAV). METHODS: We evaluated the early and mid-term outcome of patients with stenotic BAV who underwent SAVR or TAVR for aortic stenosis from the nationwide FinnValve registry. RESULTS: The FinnValve registry included 6463 AS patients and 1023 (15.8%) of them had BAV. SAVR was performed in 920 patients and TAVR in 103 patients with BAV. In the overall series, device success after TAVR was comparable to SAVR (94.2% vs. 97.1%, p = 0.115). TAVR was associated with increased rate of mild-to-severe paravalvular regurgitation (PVR) (19.4% vs. 7.9%, p < 0.0001) and of moderate-to-severe PVR (2.9% vs. 0.7%, p = 0.053). When newer-generation TAVR devices were evaluated, mild-to-severe PVR (11.9% vs. 7.9%, p = 0.223) and moderate-to-severe PVR (0% vs. 0.7%, p = 1.000) were comparable to SAVR. Type 1 N-L and type 2 L-R/R-N were the BAV morphologies with higher incidence of mild-to-severe PVR (37.5% and 100%, adjusted for new-generation prostheses p = 0.025) compared to other types of BAVs. Among 75 propensity score-matched cohorts, 30-day mortality was 1.3% after TAVR and 5.3% after SAVR (p = 0.375), and 2-year mortality was 9.7% after TAVR and 18.7% after SAVR (p = 0.268) CONCLUSIONS: In patients with stenotic BAV, TAVR seems to achieve early and mid-term results comparable to SAVR. Type 1 N-L and type 2 L-R/R-N BAV morphologies had higher incidence of PVR. Larger studies evaluating different phenotypes of BAV are needed to confirm these findings. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03385915.