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We aim to compare in-hospital and 30-day outcomes of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) for native aortic insufficiency (AI).TAVR is increasingly used off-label in patients with AI deemed high risk for SAVR. There is a paucity of data comparing TAVR and SAVR with current commercially available TAVR devices.A single-center, retrospective cohort study of patients undergoing TAVR or SAVR for native AI between 2014 and 2020 was performed. Data were obtained from the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database, Transcatheter Valve Therapy (TVT) registry, and chart review. In-hospital and 30-day outcomes are reported.Of 125 total patients, 91 underwent SAVR and 34 underwent TAVR. The TAVR group had a higher STS predictive risk of mortality (PROM) (TAVR = 3.96 %, SAVR = 1.25 %, p0.0001). In the postoperative period, the SAVR group had higher rates of new-onset atrial fibrillation (20.9 % vs. 0 %, p0.001), while the TAVR group had higher rates of complete heart block requiring permanent pacemaker implantation (20.6 % vs. 2.2 %, p0.001). There was no difference in in-hospital or 30-day mortality, stroke, myocardial infarction, residual AI, or repeat valve intervention.Despite higher STS PROM and more comorbidities, patients who underwent TAVR for AI had similar in-hospital and 30-day outcomes as patients who underwent SAVR for AI. These results support TAVR in selected high-risk patients with AI, with the knowledge that pacemaker needs may be higher than patients undergoing SAVR.

Acute kidney injury (AKI) frequently complicates cardiac surgery and is more common among Black patients. We evaluated determinants of race-based differences in AKI rates.Serum creatinine-based criteria were used to identify adult cardiac surgical patients having postoperative AKI in the Perfusion Measures and Outcomes (PERForm) Registry (July 1, 2014, to June 30, 2019). Patient characteristics, operative details, and outcomes were compared by race (Black vs White) after excluding patients with preoperative dialysis, missing preoperative or postoperative creatinine, or other races. A mixed effects model (adjusting for demographics, comorbidities, surgical factors) used hospital as a random effect to predict postoperative stage 2 or 3 AKI. Propensity score analyses were conducted to evaluate robustness of the primary analyses.The study cohort included 34 520 patients (8% Black). More Black patients than White patients were female (43% vs 27%, P.001), and had hypertension (93% vs 87%, P.001) and diabetes mellitus (51% vs 41%, P.001). Acute kidney injury of stage 2 or greater occurred in 1697 patients (5%), more often among Black than White patients (8% vs 5%, P.001). Intraoperatively, Black patients had lower nadir hematocrits (23 vs 26, P.001), and were more likely to be given transfusions (22% vs 14%, P.001). After adjustment, Black race (compared with White) independently predicted odds for postoperative AKI (adjusted odds ratio 1.50; 95% confidence interval, 1.26 to 1.78). The multivariable findings were similar in propensity score analyses.Despite accounting for differences in risk factors and intraoperative practices, Black patients had a 50% increased odds for having moderate-severe postoperative AKI compared with White patients. Additional evaluations are warranted to identify potential targets to address racial disparities in AKI outcomes.

Dual modulation of the MAPK pathway with BRAF (e.g., dabrafenib) and MEK (e.g., trametinib) inhibitors has the potential to re-establish radioiodine (RAI) sensitivity in BRAF-mutated RAI-refractory (RAI-R)-differentiated thyroid carcinoma (DTC) cells. Here we showed that (1) double BRAF/MEK inhibition may still reach a significant redifferentiation in patients with a long-history RAI-R DTC and multiple previous treatments; (2) the addition of high RAI activities may obtain a significant structural response in such patients; and (3) a divergence between increasing thyroglobulin and structural response may be a reliable biomarker or redifferentiation. Accordingly, the add-on prescription of high activities of 131I should be considered in RAI-R patients under multikinase inhibitors with stable or responding structural disease and divergent increase of Tg levels.

Background: Stroke is a known complication of cardiac surgery. The objective of this study was to implement a systemwide strategy to reduce perioperative stroke after isolated coronary artery bypass graft (CABG) surgery utilizing best practices from cardiothoracic surgery and neurology expertise. Methods: A prospective, quality improvement study of all isolated CABG patients at three hospitals within a multicenter academic healthcare system, in a large metropolitan area, was completed from January 1, 2021 to June 30, 2022. Utilizing Lean methodology, a multidisciplinary team of cardiothoracic surgeons, neurologists, anesthesiologists, certified stroke nurses, and process improvement specialists conducted a gap analysis to identify interventions to decrease the observed to expected (O/E) ratio of risk-adjusted perioperative strokes. The team developed a pre-operative evaluation process for patients with a history of stroke, formalized the utilization of intra-operative epiaortic ultrasound, and deployed education on BE-FAST symptoms and the purpose of stroke alerts to providers, nurses, and ancillary staff caring for the patient population. Results: During the study period, 1175 patients underwent isolated CABG. Risk adjusted perioperative stroke rates in the first 6 months of 2021 compared to 2022 declined from an O/E ratio of 1.32 to 0.78. Among patients with new post-operative stroke symptoms, the time frame from last known well to symptom recognition decreased from 704 to 486 minutes. Following the implementation of the protocol, one site saw the utilization of inpatient stroke alerts after CABG increase from 81.3% to 100% for patients with new BE-FAST symptoms. Conclusion: Multidisciplinary implementation of best practices was associated with lower risk adjusted perioperative stroke rates, reductions in time to new symptom recognition, and increased utilization of inpatient stroke alert processes. Further study is needed to monitor the effects of the pre-operative evaluation process and the standardization of epiaortic ultrasound. Future goals are to standardize the methods and assess the benefit to other types of cardiac surgery.

Despite follicular lymphoma (FL) is frequently characterized by a moderate increase of glucose metabolism, PET/CT examinations provides valuable information for staging and response assessment of the disease. The aim of the study was to assess and compare the diagnostic performance of PET/ldCT and PET/ceCT, respectively, in evaluating FL patients at the end of treatment. Fifty FL consecutive patients who underwent end-of-therapy PET/CT with both ldCT and ceCT were analyzed. Two blinded observers independently assessed PET/ldCT and PET/ceCT applying the Deauville score (DS) and Lugano classification criteria. PET imaging obtained after the end-of-treatment (EoT) was classified as showing PET and ce-CT matched response (concordant imaging group, CIG) or PET and ce-CT unmatched response (discordant imaging group, DIG). Relapse rate and Event-Free Survival (EFS) were compared between CIG and DIG patients. Overall, no differences in metabolic response classification were observed between PET/ldCT and PET/ceCT. In 13 (26%) patients PET/ceCT identified additional FDG-negative nodal lesions in mesenteric, retroperitoneal and iliac regions. However, in all cases, final DS remained unchanged and the additional results did not modify the following therapeutic decision. Among patients, who obtained complete metabolic response a comparable rate of relapse was registered in DIG 3/13 (23%) and CIG subgroups 5/20 (25%) [p = 0.899]. In all 3 DIG cohort patients who relapsed the recurrent disease involved also, but not exclusively, PET negative lymph nodes detected by ceCT. In overall population metabolic response defined by PET/ldCT predicted EFS [76% (group of patients with metabolic response) vs 35% (group of patients with residual disease), p = 0.0013] significantly better than ceCT-Based response assessment [75% (group of patients with complete response) vs 53% (group of patients with residual disease), p = 0.06]. Our study demonstrates a negligible diagnostic and predictive value of ceCT performed in addition to standard 18FDG PET/ldCT for EoT response evaluation in FLs. PET/ldCT should be performed as first-line imaging procedure, also in patients with prevalent abdominal and pelvic involvement, limiting the acquisition of ceCT in selected cases. This tailored approach would contribute to avoid useless radiation exposure and preserve renal function of patients.

Purpose As ~25% of cytologically indeterminate thyroid nodules harbour malignancy, diagnostic lobectomy is still performed in many cases. 18FDG PET/CT rules out malignancy in visually negative nodules; however, none of the currently available interpretation criteria differentiates malignant from benign 18FDG-avid nodules. We evaluated the ability of PET metrics and radiomics features (RFs) to predict final diagnosis of 18FDG-avid cytologically indeterminate thyroid nodules. Methods Seventy-eight patients were retrospectively included. After volumetric segmentation of each thyroid lesion, 4 PET metrics and 107 RFs were extracted. A logistic regression was performed including thyroid stimulating hormone, PET metrics, and RFs to assess their predictive performance. A linear combination of the resulting parameters generated a radiomics score (RS) that was matched with cytology classes (Bethesda III and IV) and compared with final diagnosis. Results Two RFs (shape_Sphericity and glcm_Autocorrelation) differentiated malignant from benign lesions. A predictive model integrating RS and cytology classes effectively stratified the risk of malignancy. The prevalence of thyroid cancer increased from 5 to 37% and 79% in accordance with the number (score 0, 1 or 2, respectively) of positive biomarkers. Conclusions Our multiparametric model may be useful for reducing the number of diagnostic lobectomies with advantages in terms of costs and quality of life for patients.

Objectives The purpose of this study was to evaluate tip-to-base intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) in patients undergoing transcatheter mitral valve replacement (TMVR) in annuloplasty rings or surgical mitral valves. Background LAMPOON is an effective adjunct to TMVR that prevents left ventricular outflow tract obstruction (LVOTO). Laceration is typically performed from the base to the tip of the anterior mitral leaflet. A modified laceration technique from leaflet tip to base may be effective in patients with a prosthesis that protects the aortomitral curtain. Methods This is a multicenter, 21-patient, consecutive retrospective observational cohort. Patients underwent tip-to-base LAMPOON to prevent LVOTO and leaflet overhang, or therapeutically to lacerate a long anterior mitral leaflet risking or causing LVOTO. Outcomes were compared with findings from patients in the LAMPOON investigational device exemption trial with a prior mitral annuloplasty. Results Twenty-one patients with a annuloplasty or valve prosthesis–protected mitral annulus underwent tip-to-base LAMPOON (19 preventive, 2 rescue). Leaflet laceration was successful in all and successfully prevented or treated LVOTO in all patients. No patients had significant LVOTO upon discharge. There were 2 cases of unintentional aortic valve injury (1 patient underwent emergency transcatheter aortic valve replacement and 1 patient underwent urgent surgical aortic valve replacement). In both cases, the patients had a supra-annular ring annuloplasty, and the retrograde aortic guiding catheter failed to insulate the guidewire lacerating surface from the aortic root. All patients survived to 30 days. Compared with classic retrograde LAMPOON, there was a trend toward shorter procedure time. Conclusions Tip-to-base laceration is a simple, effective, and safe LAMPOON variant applicable to patients with an appropriately positioned mitral annular ring or bioprosthetic valve. Operators should take care to insulate the lacerating surface from adjacent structures.

Background: [18F]-Fluorodeoxyglucose (FDG)-avid thyroid lesions incidentally detected on positron emission tomography/computed tomography (PET/CT) scans represent a tumor lesion in about 30% of cas...

The number of transcatheter aortic valve replacement (TAVR) procedures have increased dramatically over the last decade; so too have the number of TAVR centers. While a percutaneous femoral artery approach is the access of choice, many patients have peripheral artery disease that prohibits access despite newer smaller diameter TAVR delivery systems. It is imperative for TAVR programs to have a preferred alternative access technique. The transcarotid approach is advantageous because the surgical skills and endovascular techniques required should be familiar to most surgeons, and when not, are, in our experience, readily obtainable. Here we provide a detailed description of the technical aspects of our approach to transcarotid TAVR.

180 Background: Cabazitaxel and Lu-PSMA both improved survival in patients with mCRPC after docetaxel and an androgen receptor pathway inhibitor (ARPI), but there is limited data regarding Lu-PSMA activity after cabazitaxel. We aimed at assessing activity of Lu-PSMA and determinants of outcomes in this setting. Methods: Consecutive mCRPC patients from 6 European centers treated with Lu-PSMA after cabazitaxel were included in this retrospective study. Endpoints included radiographic progression-free survival (rPFS), time to PSA progression (PSA-TTP), PSA decline, objective response, overall survival, and safety. Results: Of 101 patients included (median age 67y), 64% had ISUP grade 4-5 disease; 71% had bone +/- nodal (LN) metastases, 22% visceral metastases, 7% LN only. All patients and 92% had received previous docetaxel and a prior ARPI (≥ 2 in 47%) before cabazitaxel respectively. Patients had received a median number of 6 cabazitaxel cycles (range 1-26). DNA damage repair alterations (DDR) were found in 11/48 (23%) patients with available testing. Patients received a median number of 3 Lu-PSMA cycles (range 1-14). With a median follow-up of 5.7 months, the median rPFS from Lu-PSMA initiation was 4.3 months (m, 95%CI 3.2-5.7) and median PSA-TTP was 3.5 m (95%CI 3.0-4.5). Overall, 44 patients (44%) experienced a PSA decline ≥ 50% (PSA50), 54 (53%) ≥ 30% (PSA30), and 67 (66%) any PSA decline. Objective response rate was 34%. Baseline characteristics associated with shorter rPFS on Lu-PSMA included ISUP grade 4-5 disease (median rPFS of 3.5 vs. 7.2m, p=0.02) and a time to castration resistance < 12 months (3.1m vs. 4.5m, p=0.04). Patients with LN only had longer rPFS compared to those with bone and visceral metastases (median NR vs. 3.6 and 3.7m, respectively, p=0.02). There was no association between activity of Lu-PSMA and DNA damage repair alterations, duration of previous cabazitaxel therapy, and number of previous ARPI. During Lu-PSMA, a profound PSA decline was associated with longer rPFS: patients achieving PSA50, PSA30 or any PSA decline had respective median rPFS rates of 9.0, 8.3 and 6.2 months, while those who did not experience any PSA decline had a median rPFS of only 2.6 months. Conclusions: Lu-PSMA demonstrated substantial PSA decline but limited duration of response after cabazitaxel in a real-life setting. Adverse baseline characteristics and absence of PSA decline may help early identification of poor responders.

Paravalvular leak (PVL) remains a key limitation of transseptal transcatheter mitral valve replacement (TMVR) using the SAPIEN 3 valve (Edwards Lifesciences, Irvine, California), especially in prior surgical rings (VIR) or mitral annular calcification (VIM) ([1][1],[2][2]). PVL often results from

Background Pneumonia is the most prevalent healthcare-associated infection after coronary artery bypass grafting (CABG), but the relative effectiveness of strategies to reduce its incidence remains unclear. We evaluated the relationship between healthcare-associated infection recommendations and risk of pneumonia after CABG. Methods Pneumonia prevention practice recommendations were developed based on literature review and analysis of semistructured interviews with key health care personnel across centers with low ( 6.1%) rates of pneumonia. These practices were implemented among 2482 patients undergoing CABG from 2016 to 2017 across 18 centers. The independent effect of each practice in reducing pneumonia was assessed using multivariable logistic regression, adjusting for baseline risk and center. A composite (bundle) score was calculated as the number of practices (0 to 4) each patient received. Results Recommended pneumonia prevention practices included lung protective ventilation management, early extubation, progressive ambulation, and avoidance of postoperative bronchodilator therapy. Pneumonia occurred in 2.4% of patients. Lung protective ventilation (adjusted odds ratio [ORadj], 0.45; 95% confidence interval [CI], 0.22-0.92), ambulation (ORadj, 0.08; 95% CI, 0.04-0.17), and postoperative ventilation of less than 6 hours (ORadj, 0.47; 95% CI, 0.26-0.87) were significantly associated with lower odds of pneumonia. Postoperative bronchodilator therapy (ORadj, 4.83; 95% CI, 2.20-10.7) was significantly associated with higher odds. Risk-adjusted rates of pneumonia, operative mortality, and intensive care unit length of stay were lower in patients with higher bundle scores (all P-trend Conclusions These pneumonia prevention recommendations may serve as effective targets for avoiding postoperative healthcare-associated infections.

Focal thyroid incidentaloma (TI) occurs in a 2% of 18F-FDG PET/CT and about one-third of TIs is cancer. Due to the lack of evidence on the optimal management of TI, current guidelines suggest performing fine-needle aspiration cytology (FNA). The study aim was to evaluate the reliability of ACR-TIRADS, EU-TIRADS, and K-TIRADS in indicating FNA in TIs. We retrospectively reviewed 18F-FDG PET/CT TIs recorded during the period 2016–2019. Enrolled were TIs with histologic outcome and autonomous nodules. Cases with uncertain matching between 18F-FDG PET/CT, US/scintiscan and histology were excluded. Eighty TIs at 18F-FDG PET/CT (median size 17 mm, median SUVmax 7.85) were included; a 26.2% was cancer. The percentage of nodules classified as high risk according to ACR-TIRADS, EU-TIRADS, and K-TIRADS was 20%, 30%, and 29.8%, respectively. The cancer prevalence in high-risk class was 56.2%, 66.7%, and 65.2% in ACR-TIRADS, EU-TIRADS, and K-TIRADS, respectively. ACR-TIRADS had the lowest number of cases with FNA indication (48%) and the K-TIRADS, the highest one (75%). Evaluating the reliability of the three systems in indicating FNA, we found a 100% sensitivity and NPV for EU-TIRADS and K-TIRADS; while all the three systems showed poor specificity and PPV. All TIRADSs were reliable to stratify the risk of cancer in focal TI. Comparing their reliability in indicating FNA, we found a good performance of EU-TIRADS and K-TIRADS. Considering the high cancer percentage expected in this setting of patients, those TIRADS with higher propensity to indicate FNA should be preferred.

A universal recommendation does not exist for thyroid FNA suspicious for malignancy (SFM). In this context, the guidelines have estimated a risk of malignancy (ROM) from 50 to 80% and both total thyroidectomy and lobectomy may be indicated. This study aimed to (1) retrospectively evaluate the SFM (i.e., TIR4) in a single institution to estimate their cancer prevalence at histology, and (2) systematic review the literature to obtain more robust information. The study period was 2015–2018. As a major inclusion criterion, both cytology and histology had to be performed in our institution. Histological diagnosis was the gold standard. For the systematic review, the online databases of Google Scholar, PubMed/MEDLINE, and Scopus were searched for papers using the same classification for thyroid FNA. A proportion meta-analysis was performed to obtain the pooled histological cancer rate among TIR4 and TIR5 (random-effects model). In the institutional database, there were 271 nodules with both histology and FNA and the cancer rate of TIR4 was 88.9%. By systematic review, five studies were selected for the meta-analysis. The pooled cancer rate was 85% in TIR4 and 99% in TIR5 (I2 = 0%; no publication bias). In conclusion, these new findings should prompt the guidelines board to fully revise the estimated ROM of SFM category. Clinical thyroidologists and thyroid surgeons should be aware of these data and the patients with SFM should be informed of their ROM.

Objectives The aim of this study was to report the 2-year results of the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial and confirm the interim Bayesian analysis. Background Transcatheter aortic valve replacement (TAVR) with a self-expanding valve was noninferior to surgery in patients with severe aortic stenosis and intermediate operative risk using Bayesian statistical methods. Novel Bayesian designs have been used to shorten the time to primary endpoint analysis in randomized clinical trials, although the predictive value of Bayesian analysis compared with frequentist approaches remains debated. Methods The SURTAVI trial randomized 1,660 patients. An interim analysis was performed 1 year after the 1,400th patient was treated to estimate the primary 2-year endpoint of all-cause mortality or disabling strokes for all patients. Results The Kaplan-Meier rate for the complete 2-year primary endpoint was 12.7% in the TAVR group and 12.6% in the surgery group (0.0% difference; 95% confidence interval: −3.4% to 3.5%), compared with 12.6% with TAVR and 14.0% with surgery (−1.4% difference; Bayesian credible interval: −5.2% to 2.3%) in the interim Bayesian analysis. A comparison of individual clinical, hemodynamic, and quality-of-life endpoints using Bayesian and frequentist methods found no significant differences. Conclusions The complete analysis of all patients with aortic stenosis at intermediate risk for surgery in the SURTAVI trial confirmed the noninferiority, with respect to the frequency of all-cause mortality or disabling stroke, of TAVR to surgery, as determined in the interim Bayesian analysis. Follow-up will extend out to 10 years.

Objectives This study sought to test safety and exploratory effectiveness of a dedicated transcaval closure device (TCD). Background Transcaval access enables delivery of large-caliber devices to the aorta in patients ineligible for transfemoral arterial access. Closure of aortocaval fistulae using off-label nitinol cardiac occluders has been shown to be safe, but persistent aortocaval fistulae at exit from the catheterization lab and bleeding complications were common in a prospective study. Methods Preclinical testing of the TCD was performed in 24 Yorkshire swine, including 10 under good laboratory practice conditions. Subsequently, subjects undergoing transcatheter aortic valve replacement for symptomatic severe aortic stenosis, ineligible for transfemoral arterial access, were enrolled in a U.S. Food and Drug Administration–approved early feasibility study of the TCD (Transmural Systems, Andover, Massachusetts). Independently adjudicated endpoints included technical, device, and procedural success, incorporating in-hospital and 30-day clinical and imaging follow-up. Results Transcaval access and closure in swine confirmed that at 30 days, TCDs were almost entirely endothelialized. Subsequently, 12 subjects were enrolled in the early feasibility study. Transcaval access, transcatheter aortic valve replacement, and aortocaval fistula closure was successful in all 12 subjects. The primary endpoint of technical success was met in 100% of subjects. Complete closure of the transcaval access tract was achieved in 75% of subjects at exit from the catheterization lab and in 100% of subjects at 30 days. There were zero modified Valve Academic Research Consortium-2 major vascular complications and zero Valve Academic Research Consortium-2 life-threatening or major bleeding complications related to transcaval access or the TCD. Conclusions The TCD achieved complete closure of the transcaval access tract in most subjects at exit from the catheterization lab and essentially eliminated transcaval-related bleeding. Dedicated devices for transcaval access and closure could enable more widespread adoption of transcaval techniques without fear of bleeding complications. (Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement; NCT03432494).

Background: Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) and laceration of the anterior mitral leaflet to prevent outflow obstruction (LAMPOON) reduce the risk of coronary and left ventricular outflow obstruction obstruction during transcatheter aortic valve replacement and transcatheter mitral valve replacement. Despite successful laceration, BASILICA or LAMPOON may fail to prevent obstruction caused by inadequate leaflet splay in patients having challenging anatomy such as very small valve-to-coronary distance, diffusely calcified, rigid leaflets, or undergoing transcatheter aortic valve replacement inside existing transcatheter aortic valve replacement. We describe a novel technique of balloon-augmented (BA) leaflet laceration to enhance leaflet splay. Methods: We measured the incremental leaflet splay from BA-BASILICA in vitro. From November 2019 to March 2021, 16 patients underwent BA-BASILICA and 4 BA-LAMPOON at 3 centers. Results: BA-BASILICA increased benchtop leaflet tip splay 17%, maximum splay angle 30%, and splay area 23%, resulting in a more rounded apex and larger effective area. Sixteen patients at risk for inadequate BASILICA leaflet splay, including 4 transcatheter aortic valve replacement inside existing transcatheter aortic valve replacement, underwent BA-BASILICA. All had successful leaflet laceration. One had coronary obstruction requiring immediate orthotopic stenting. Two underwent elective orthotopic coronary stenting through the transcatheter valve cells for leaflet prolapse without coronary ischemia. There were no deaths during the procedure or at 30 days. Four patients at risk for inadequate anterior mitral leaflet splay underwent BA-LAMPOON. All had successful target leaflet laceration without left ventricular outflow obstruction obstruction or procedural death. One died within 30 days. Conclusions: BA leaflet laceration enhances leaflet splay in vitro and may allow transcatheter aortic valve replacement and transcatheter mitral valve replacement in patients otherwise ineligible for traditional BASILICA or LAMPOON due to challenging anatomy. Graphic Abstract: A graphic abstract is available for this article.

In recent years, a large number of articles have described the endocrine-related adverse events associated with immune checkpoint inhibitors, especially affecting the thyroid. A 37-year-old man affected by nasopharyngeal carcinoma (stage IVb) underwent serial 18F-FDG PET/CT evaluations during treatment with nivolumab (480 mg every 4 weeks) after first-line chemoradiotherapy. The patient had no history of thyroid disease and before starting immunotherapy the thyroid-stimulating hormone value was normal at 0.9 mU/L (reference range, 0.27-4.2 mIU/L). FDG PET/CT studies revealed involution of the thyroid gland following immune checkpoint inhibitor-induced thyroiditis.

Context Calcitonin (CT) measurement is pivotal in the management of medullary thyroid carcinoma (MTC), but several pitfalls can affect its reliability. Procalcitonin (ProCT) has been reported as a promising alternative MTC tumor marker. Objective This study aimed to determine the ProCT diagnostic accuracy in prediction and treatment monitoring of MTC. Methods Electronic databases were searched for observational studies published until May 2021 without language or time restrictions. Studies comparing ProCT and calcitonin accuracy were included. After removing duplicates and exclusion of not-eligible articles, relevant articles were screened independently by 2 reviewers. Eleven studies (4.5% of the identified studies) met the selection criteria. Two reviewers independently extracted data and assessed data quality and validity through QUADAS-2. Results A meta-analysis was performed on 11 sufficiently clinically and statistically homogeneous studies (n = 5817 patients, 335 MTC patients). Hierarchical summary receiver operating characteristics and bivariate methods were applied. Serum ProCT was found to be a highly accurate test for MTC diagnosis and monitoring. The pooled sensitivity, specificity, positive and negative likelihood ratios, area under the curve, and positive and negative predictive values for ProCT were 0.90 (95% CI: 0.71-0.97), 1.00 (95% CI: 0.85-1.00), 288 (95% CI: 5.6-14 929.3), 0.10 (95% CI: 0.03-0.33), 0.97 (95% CI: 0.95-0.98), 99%, and 2%, respectively. Conclusions The high accuracy, compounded with favorable analytical characteristics, give ProCT great potential to replace calcitonin as a new standard of care in the management of MTC.

The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) is the world's premier clinical outcomes registry for adult cardiac surgery and a driving force for quality improvement in cardiac surgery. Echocardiographic data provide a wealth of hemodynamic, structural, and functional data and have been part of STS ACSD data collection since its inception. An increasing body of evidence suggests that the use of echocardiography in patients undergoing cardiac surgery has a positive impact on postoperative outcomes. In this report, we describe and summarize the type and rate of reporting of echocardiography-related variables in the STS ACSD, including the Adult Cardiac Anesthesiology Module, from July 2017 to December 2019 for the most frequently performed cardiac surgical procedures. With this review, we aim to increase awareness of the importance of collecting accurate and consistent echocardiography data in the STS ACSD and to highlight opportunities for growth and improvement.

Background: Coronary artery obstruction is a rare, devastating complication of transcatheter aortic valve replacement. Transcatheter electrosurgical aortic leaflet laceration (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction [BASILICA]) is a novel technique to prevent coronary artery obstruction. We report the 1-year outcomes of the BASILICA trial. Primary end points of 30-day success and safety have been reported previously. Methods: The BASILICA trial was a prospective, multicenter, single-arm safety and feasibility study. Subjects with severe native or bioprosthetic aortic valve disease at high or extreme risk for surgery, and high risk of coronary artery obstruction, were included. End points at 1 year included death, stroke, and myocardial infarction. Source data was independently verified and end points independently adjudicated. Results: Thirty subjects were enrolled between February 2018 and July 2018. At 30 days, BASILICA was successful in 28 subjects (93.3%), there were 3 strokes (10%), including 1 disabling stroke (3.3%), 1 death (3.3%), and 1 periprocedural myocardial infarction (3.3%). Between 30 days and 1 year, there were no additional strokes, no myocardial infarction, and 2 deaths (10% 1-year mortality). No subject needed repeat intervention for aortic valve or coronary disease. Two subjects had infective endocarditis (6.7%), but neither was isolated to the aortic valve. There were no hospital admissions for heart failure. Fourteen (46.7%) subjects required repeat hospital admission for other causes. Aortic valve gradients on echocardiography, New York Heart Association functional class, and Kansas City Cardiomyopathy Questionnaire scores improved from baseline to 30 days and were maintained at 1 year. Conclusions: In these subjects with multiple comorbidities and restrictive anatomy that underwent transcatheter aortic valve replacement, there was no late stroke, myocardial infarction, or death related to BASILICA. Mitigation of coronary obstruction remained intact at 1 year and was not related to recurrent readmission. These results are reassuring for patients and physicians who wish to avoid the long-term complications related to snorkel stenting. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03381989.

The Society of Thoracic Surgeons (STS) original coronary artery bypass graft surgery (CABG) composite measure uses a 1-year analytic cohort and 98% credible intervals (CrI) to classify better than expected (3-star) performance or worse than expected (1-star) performance. As CABG volumes per STS participant (eg, hospital or practice group) have decreased, it has become more challenging to classify performance categories using this approach, especially for lower volume programs, and alternative approaches have been explored.Among 990 STS Adult Cardiac Surgery Database participants, performance classifications for the CABG composite were studied using various analytic cohorts: 1 year (current approach, 2017); 3 years (2015 to 2017); last 450 cases within 3 years; and most recent year (2017) plus additional cases to 450 total. We also compared 98% CrI with 95% CrI (used in other STS composite measures).Using 3 years of data and 95% CrIs, 113 of 990 participants (11.4%) were classified 1-star and 198 (20%) 3-star. Compared with 1-year analytic cohorts and 98% CrI, the absolute and relative increases in the proportion of 3-star participants were 14 percentage points and 233% (n = 198 [20%] vs n = 59 [6%]). Corresponding changes for 1-star participants were 6.5 percentage points and 133% (n = 113 [11.4%] vs n = 48 [4.9%]). These changes were particularly notable among lower volume (fewer than 199 CABG per year) participants. Measure reliability with the 3-year, 95% CrI modification is 0.78.Compared with current STS CABG composite methodology, a 3-year analytic cohort and 95% CrI increases the number and proportion of better or worse than expected outliers, especially among lower-volume Adult Cardiac Surgery Database participants. This revised methodology is also now consistent with other STS procedure composites.

BACKGROUND: Left ventricular outflow tract (LVOT) obstruction is a leading cause of mortality and exclusion from transcatheter mitral valve replacement (TMVR). Intentional laceration of the anterior mitral valve leaflet to prevent LVOT obstruction (LAMPOON) is a transcatheter mimic of surgical chord-sparing leaflet resection. OBJECTIVES: The purpose of this prospective multicenter trial was to study LAMPOON with transseptal (Edwards Lifesciences, Irvine, California) TMVR in annuloplasty rings or native mitral annular calcification (MAC). METHODS: Subjects at high or extreme surgical risk and prohibitive risk of LVOT obstruction from TMVR were included. Eligibility was modified midtrial to exclude subjects with threatened LVOT obstruction from a Sapien 3 valve fabric skirt. The primary endpoint was procedure survival with successful LAMPOON, with successful TMVR, without reintervention, and with LVOT gradient

Background: This study aimed to evaluate the role of 18F-choline (18F-FCH) positron emission tomography (PET)/computed tomography (CT) in high-risk differentiated thyroid cancer (DTC) patients with...

Objectives The authors investigated 1-year outcomes after transcaval access and closure for transcatheter aortic valve replacement (TAVR), using commercially available nitinol cardiac occluders off-label. Background Transcaval access is a fully percutaneous nonfemoral artery route for TAVR. The intermediate-term fate of transcaval access tracts is not known. Methods The authors performed a prospective, multicenter, independently adjudicated trial of transcaval access, using Amplatzer nitinol cardiac occluders (Abbott Vascular, Minneapolis, Minnesota), among subjects without traditional transthoracic (transapical or transaortic) access options. One-year clinical follow-up included core laboratory analysis of serial abdominal computed tomography (CT). Results 100 subjects were enrolled. Twelve-month mortality was 29%. After discharge, there were no vascular complications of transcaval access. Among 83 evaluable CT scans after 12 months, 77 of fistulas (93%) were proven occluded, and only 1 was proven patent. Fistula patency was not associated with overall survival (p = 0.37), nor with heart failure admissions (15% if patent vs. 23% if occluded; p = 0.30). There were no cases of occluder fracture or migration or visceral injury. Conclusions Results are reassuring 1 year after transcaval TAVR and closure using permeable nitinol occluders off-label. There were no late major vascular complications. CT demonstrated spontaneous closure of almost all fistulas. Results may be different in a lower-risk cohort, with increased operator experience, and using a dedicated transcaval closure device. (Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access; NCT02280824)

Background Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated. Objectives The purpose of this study was to examine outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis. Methods The Global Feasibility Study enrolled symptomatic patients with either primary or secondary mitral regurgitation (MR) who were at high or prohibitive surgical risk. The present investigation examines the first 100 patients treated in this study. Clinical outcomes through last clinical follow-up were adjudicated independently. Results In the cohort (mean age 75.4 ± 8.1 years; 69% men), there was a high prevalence of severe heart failure symptoms (66%), left ventricular dysfunction (mean ejection fraction 46.4 ± 9.6%), and morbidities (Society of Thoracic Surgeons Predicted Risk of Mortality, 7.8 ± 5.7%). There were no intraprocedural deaths, 1 instance of major apical bleeding, and no acute conversion to surgery or need for cardiopulmonary bypass. Technical success was 96%. The 30-day rates of mortality and stroke were 6% and 2%, respectively. The 1-year survival free of all-cause mortality was 72.4% (95% confidence interval: 62.1% to 80.4%), with 84.6% of deaths due to cardiac causes. Among survivors at 1 year, 88.5% were New York Heart Association function class I/II, and improvements in 6-min walk distance (p Conclusions In this study of TMVR, which is the largest experience to date, the prosthesis was highly effective in relieving MR and improving symptoms, with an acceptable safety profile. Further study to optimize the impact on long-term survival is needed.

The Society of Thoracic Surgeons Adult Cardiac Surgery Database is one of the most mature, comprehensive, and respected clinical data registries in health care. Through nearly three decades of growth and refinement, it is widely recognized for accurately benchmarking risk-adjusted outcomes in cardiac surgery and serves as the foundation for all quality measurement and improvement activities of The Society of Thoracic Surgeons. This is the fourth in a series of annual reports that provides updated national outcomes, volume trends, and database-related developments in quality measurement and performance improvement.