Impact of coronary calcium morphology on intravascular lithotripsy.

BACKGROUND: Coronary calcification negatively impacts optimal stenting. Intravascular lithotripsy (IVL) is a new calcium modification technique. AIMS: We aimed to assess the impact of different calcium morphologies on IVL efficacy. METHODS: This was a prospective, multicentre study (13 tertiary referral centres). Optical coherence tomography (OCT) was performed before and after IVL, and after stenting. OCT-defined calcium morphologies were concentric (mean calcium arc >180°) and eccentric (mean calcium arc ≤180°). The primary outcomes were angiographic success (residual stenosis <20%) and the presence of fracture by OCT in concentric versus eccentric lesions. RESULTS: Ninety patients were included with a total of 95 lesions: 47 concentric and 48 eccentric. The median number of pulses was 60 (p=1.00). Following IVL, the presence of fracture was not statistically different between groups (79.0% vs 66.0% for concentric vs eccentric; p=0.165). The number of fractures/lesion (4.2±4.4 vs 2.3±2.8; p=0.018) and ≥3 fractures/lesion (57.1% vs 34.0%; p=0.029) were more common in concentric lesions. Angiographic success was numerically but not statistically higher in the concentric group (87.0% vs 76.6%; p=0.196). By OCT, no differences were noted in final minimum lumen area (5.9±2.2 mm2 vs 6.2±2.1 mm2; p=0.570), minimum stent area (5.9±2.2 mm² vs 6.25±2.4 mm2; p=0.483), minimum stent expansion (80.9±16.7% vs 78.2±19.8%), or stent expansion at the maximum calcium site (100.6±24.2% vs 95.8±27.3%) (p>0.05 for all comparisons of concentric vs eccentric, respectively). Calcified nodules were found in 29.5% of lesions; these were predominantly non-eruptive (57%). At the nodule site, dissection was more common than fracture with stent expansion of 103.6±27.2%. CONCLUSIONS: In this prospective, multicentre study, the effectiveness of IVL followed by stenting was not significantly affected by coronary calcium morphology.

Pulsed Electric Field (PEF) treatment of progressive non-small cell lung cancer concurrently treated with immune checkpoint blockade: A case report.

Pulsed Electric Field (PEF) energy was delivered at the time of confirmational biopsy to ablate recurrent NSCLC in the right upper lobe (RUL) of the lung after recurrence while on durvalumab consolidation. The patient tolerated the procedure and exhibited stable disease at 6 and 12 months from time of durvalumab discontinuation and PEF treatment, respectively. This report represents the first use of the Aliya™ PEF system as a minimally invasive modality with potential to re-sensitize disease to immune checkpoint blockade (ICB) upon progression. Clinicaltrialsgov identifier: NCT04773275.

Impacto pronóstico a diez años del fallo del vaso diana tras un IAMCEST. Perspectivas del ensayo EXAMINATION-EXTEND / Ten-year prognostic impact of target versus non-target vessel failure after STEMI. Insight from the EXAMINATION-EXTEND trial

Introducción y objetivos Se desconoce el impacto pronóstico de los diferentes tipos de eventos adversos tras el infarto agudo de miocardio con elevación del segmento ST (IAMCEST). El objetivo de este trabajo es evaluar los predictores a largo plazo del objetivo combinado orientado al paciente (POCE) y si tener un fallo del vaso diana (FVD) como primer evento puede influir en los resultados. Métodos El ensayo EXAMINATION-EXTEND aleatorizó a pacientes con IAMCEST a tratamiento con stents liberadores de everolimus o a stents convencionales, con un seguimiento de hasta 10 años. En la población del estudio, se evaluaron los predictores de POCE (combinado de mortalidad por cualquier causa, infarto de miocardio y cualquier revascularización). Se clasificó a los pacientes según el tipo de primer evento (FVD primero o FDV no primero) y comparado en términos de POCE posterior. El FVD se definió como el compuesto de muerte cardiaca, IAMCEST del vaso diana y revascularización del vaso diana. Resultados De los 1.498 pacientes del estudio, 529 (35,3%) tuvieron POCE durante el seguimiento a los 10 años. Los predictores independientes de POCE fueron la edad, la diabetes mellitus, el infarto de miocardio previo, la enfermedad arterial periférica y la enfermedad coronaria multivaso. El primer evento fue un FVD o no FVD en 296 y 233 casos respectivamente. No hubo diferencias estadísticamente significativas entre quienes tuvieron primero un FVD y los que tuvieron un evento no FVD en cuanto a POCE (el 21,7 frente al 39,3%; razón de tiempo, 1,79; IC95%, 0,87-3,67; p=0,12) o sus componentes individuales. Conclusiones En el seguimiento a 10 años, alrededor de un tercio de los pacientes con IAMCEST tuvo al menos 1 evento de POCE, cuyos predictores independientes fueron la edad, la diabetes mellitus y una mayor extensión de la enfermedad ateroesclerótica... (AU)

Introduction and objectivesAfter ST-segment myocardial infarction (STEMI), the impact of different adverse events on prognosis remains unknown. We aimed to assess very long-term predictors of patient-oriented composite endpoints (POCE) and investigate whether the occurrence of target vessel failure (TVF) vs a non-TVF event as the first event could potentially influence subsequent outcomes. Methods The EXAMINATION.EXTEND trial randomized STEMI patients to receive either an everolimus-eluting stent or a bare-metal stent. The follow-up period was 10 years. Predictors of POCE (a composite of all-cause death, any myocardial infarction, or any revascularization) were evaluated in the overall study population. The patients were stratified based on the type of first event (TVF-first vs non–TVF-first) and were compared in terms of subsequent POCE. TVF was defined as a composite of cardiac death, TV myocardial infarction, or TV revascularization. Results Out of the 1498 enrolled patients, 529 (35.3%) experienced a POCE during the 10-year follow-up. Independent predictors of POCE were age, diabetes mellitus, previous myocardial infarction, peripheral arterial disease, and multivessel coronary disease. The first event was a TVF in 296 patients and was a non-TVF in 233 patients. No significant differences were observed between TVF-first and non–TVF-first patients in terms of subsequent POCE (21.7% vs 39.3%, time ratio 1.79; 95%CI, 0.87-3.67; P=.12) or its individual components. Conclusions At the 10-year follow-up, approximately one-third of STEMI patients had experienced at least 1 POCE. Independent predictors of these events were age, diabetes, and more extensive atherosclerotic disease. The occurrence of a TVF or a non-TVF as the first event did not seem to influence subsequent outcomes. Trial registration number: NCT04462315. (AU)

Sternal resection and reconstruction: a review.

Sternal resection and reconstruction is a rare but sometimes challenging procedure due to its profound anatomical and functional implications. For these reasons, an adequate preoperative evaluation is crucial in each patient, especially when we are faced with malignant lesions that sometimes require extensive radical resections, thus demanding an integrated reconstructive strategy that allows stabilizing the chest wall, protecting the underlying mediastinum and minimize resulting deformity. The large number of available reconstruction techniques and the lack of quality studies for their analysis mean that sternal reconstruction depends to a great extent on the consensus of experts or, more frequently, on the simple preference of each surgical team. This article aims to provide an overview of sternal resection and reconstruction. Indications for partial versus total or subtotal sternectomy are suggested and their surgical and oncological outcomes are presented. The use of rigid or semi-rigid prostheses is an ongoing debate, although recent functional data advise reserving rigid reconstructions for extensive defects. Sternectomy for primary tumors or local tumor involvement has a good prognosis with an overall survival of 5 and 10 years: 67% and 58%, respectively, provided that a radical resection with free surgical margins is performed. Breast cancer is the most common secondary sternal tumor, and surgery can offer 5-year overall survival ranging from 20% to 50% provided an R0 resection is achieved, although radical surgery does not appear to decrease rates. of recurrence. Metastases of origin other than the breast give the worst results (less than 40% at 36 months and 0% at 5 years) and although the data available on these cases are limited, the radicality of the resection does not seem to modify the survival or recurrence rates, so a conservative approach is probably more appropriate.

Operative outcomes and middle-term survival of robotic-assisted lung resection for clinical stage IA lung cancer compared with video-assisted thoracoscopic surgery / Resultados postoperatorios y de supervivencia a medio plazo de las resecciones pulmonares asistidas por robot en el cáncer de pulmón en estadio clínico IA en comparación con la cirugía toracoscópica videoasistida

Background: Despite limited published evidence, robotic-assisted thoracoscopic surgery (RATS) for anatomic lung resection in early-stage lung cancer continues growing. The aim of this study is to evaluate its safety and oncologic efficacy compared to video-assisted thoracoscopic surgery (VATS). Methods: Single-centre retrospective study of all patients with resected clinical stage IA NSCLC who underwent RATS or VATS anatomic lung resection from June 2018 to January 2022. RATS and VATS cases were matched by propensity scoring (PSM) according to age, sex, histology, and type of resection. Short-term outcomes were compared, and the Kaplan-Meier method and log-rank test were used to evaluate the overall survival (OS) and disease-free survival (DFS). Results: 321 patients (94 RATS and 227 VATS cases) were included. After PSM, 94 VATS and 94 RATS cases were compared. Demographics, pulmonary function, and comorbidity were similar in both groups. Overall postoperative morbidity was comparable for RATS and VATS cases (20.2% vs 25.5%, P = 0.385, respectively). Pathological nodal upstaging was similar in both groups (10.6% in RATS and 12.8% in VATS). During the 3.5-year follow-up period (median: 29 months; IQR: 18–39), recurrence rate was 6.4% in RATS group and 18.1% in the VATS group (P = 0.014). OS and DFS were similar in RATS and VATS groups (log rank P = 0.848 and P = 0.117, respectively). Conclusion: RATS can be performed safely in patients with early-stage NSCLC. For clinical stage IA disease, robotic anatomic lung resection offers better oncologic outcomes in terms of recurrence, although there are no differences in OS and DFS compared with VATS.(AU)

Introducción: A pesar de la limitada evidencia disponible, el uso de la RATS en resecciones pulmonares anatómicas por cáncer continúa creciendo. El objetivo de este estudio es evaluar su seguridad y eficacia oncológica en comparación con la VATS. Métodos: Estudio retrospectivo unicéntrico en el que se incluyeron todos los pacientes con CPNM en estadio cIA sometidos a resección pulmonar anatómica RATS o VATS entre junio de 2018 y enero de 2022. Los casos se emparejaron mediante puntuación de propensión (PSM) según edad, sexo, histología y tipo de resección. Se compararon los resultados a corto plazo y la supervivencia global (OS) y libre de enfermedad (DFS) mediante el método de Kaplan-Meier y la prueba de rangos logarítmicos. Resultados: Se incluyeron 321 pacientes (94 RATS y 227 VATS). Tras el PSM, se compararon 94 VATS y 94 RATS. La morbilidad global fue comparable en ambos grupos (20.2 % en RATS vs 25.5 % en VATS, P = 0.385). El upstaging ganglionar fue similar en ambos abordajes (10.6% en RATS y 12.8% en VATS). Durante los 3.5 años de seguimiento, la tasa de recurrencia fue del 6.4 % en RATS y del 18.1 % en VATS (P = 0.014). OS y DFS fueron similares en los dos grupos (rango logarítmico P = 0.848 y P = 0.117, respectivamente). Conclusión: La RATS se puede realizar de forma segura en pacientes con CPNM en estadio inicial. Para la enfermedad en estadio cIA, el abordaje robótico ofrece mejores resultados en términos de recurrencia, aunque no hay diferencias en la OS y la DFS en comparación con la VATS.(AU)

Operative outcomes and middle-term survival of robotic-assisted lung resection for clinical stage IA lung cancer compared with video-assisted thoracoscopic surgery.

BACKGROUND: Despite limited published evidence, robotic-assisted thoracoscopic surgery (RATS) for anatomic lung resection in early-stage lung cancer continues growing. The aim of this study is to evaluate its safety and oncologic efficacy compared to video-assisted thoracoscopic surgery (VATS). METHODS: Single-centre retrospective study of all patients with resected clinical stage IA NSCLC who underwent RATS or VATS anatomic lung resection from June 2018 to January 2022. RATS and VATS cases were matched by propensity scoring (PSM) according to age, sex, histology, and type of resection. Short-term outcomes were compared, and the Kaplan-Meier method and log-rank test were used to evaluate the overall survival (OS) and disease-free survival (DFS). RESULTS: 321 patients (94 RATS and 227 VATS cases) were included. After PSM, 94 VATS and 94 RATS cases were compared. Demographics, pulmonary function, and comorbidity were similar in both groups. Overall postoperative morbidity was comparable for RATS and VATS cases (20.2% vs 25.5%, P = 0.385, respectively). Pathological nodal upstaging was similar in both groups (10.6% in RATS and 12.8% in VATS). During the 3.5-year follow-up period (median: 29 months; IQR: 18-39), recurrence rate was 6.4% in RATS group and 18.1% in the VATS group (P = 0.014). OS and DFS were similar in RATS and VATS groups (log rank P = 0.848 and P = 0.117, respectively). CONCLUSION: RATS can be performed safely in patients with early-stage NSCLC. For clinical stage IA disease, robotic anatomic lung resection offers better oncologic outcomes in terms of recurrence, although there are no differences in OS and DFS compared with VATS.

Ten-year prognostic impact of target versus non-target vessel failure after STEMI. Insight from the EXAMINATION-EXTEND trial.

INTRODUCTION AND OBJECTIVES: After ST-segment myocardial infarction (STEMI), the impact of different adverse events on prognosis remains unknown. We aimed to assess very long-term predictors of patient-oriented composite endpoints (POCE) and investigate whether the occurrence of target vessel failure (TVF) vs a non-TVF event as the first event could potentially influence subsequent outcomes. METHODS: The EXAMINATION-EXTEND trial randomized STEMI patients to receive either an everolimus-eluting stent or a bare-metal stent. The follow-up period was 10 years. Predictors of POCE (a composite of all-cause death, any myocardial infarction, or any revascularization) were evaluated in the overall study population. The patients were stratified based on the type of first event (TVF-first vs non-TVF-first) and were compared in terms of subsequent POCE. TVF was defined as a composite of cardiac death, TV myocardial infarction, or TV revascularization. RESULTS: Out of the 1498 enrolled patients, 529 (35.3%) experienced a POCE during the 10-year follow-up. Independent predictors of POCE were age, diabetes mellitus, previous myocardial infarction, peripheral arterial disease, and multivessel coronary disease. The first event was a TVF in 296 patients and was a non-TVF in 233 patients. No significant differences were observed between TVF-first and non-TVF-first patients in terms of subsequent POCE (21.7% vs 39.3%, time ratio 1.79; 95%CI, 0.87-3.67;P=.12) or its individual components. CONCLUSIONS: At the 10-year follow-up, approximately one-third of STEMI patients had experienced at least 1 POCE. Independent predictors of these events were age, diabetes, and more extensive atherosclerotic disease. The occurrence of a TVF or a non-TVF as the first event did not seem to influence subsequent outcomes. TRIAL REGISTRATION NUMBER: NCT04462315.

Autologous mesenchymal stromal cells embedded with Tissucol Duo® for prevention of air leak after anatomical lung resection: results of a prospective phase I/II clinical trial with long-term follow-up.

BACKGROUND: Prolonged air leak (PAL) is the most frequent complication after pulmonary resection. Several measures have been described to prevent the occurrence of PAL in high-risk patients, however, the potential role of mesenchymal stem cells (MSCs) applied in the parenchymal suture line to prevent postoperative air leak in this setting has not been fully addressed. OBJECTIVE: To analyse the feasibility, safety and potential clinical efficacy of the implantation of autologous MSCs embedded in Tissucol Duo® as a prophylactic alternative to prevent postoperative prolonged air leak after pulmonary resection in high-risk patients. STUDY DESIGN: Phase I/II single-arm prospective clinical trial. METHODS: Six patients with high risk of PAL undergoing elective pulmonary resection were included. Autologous bone marrow-derived MSCs were expanded at our Good Manufacturing Practice (GMP) Facility and implanted (embedded in a Tissucol Duo® carrier) in the parenchymal suture line during pulmonary resection surgery. Patients were monitored in the early postoperative period and evaluated for possible complications or adverse reactions. In addition, all patients were followed-up to 5 years for clinical outcomes. RESULTS: The median age of patients included was 66 years (range: 55-70 years), and male/female ratio was 5/1. Autologous MSCs were expanded in five cases, in one case MSCs expansion was insufficient. There were no adverse effects related to cell implantation. Regarding efficacy, median air leak duration was 0 days (range: 0-2 days). The incidence of PAL was nil. Radiologically, only one patient presented pneumothorax in the chest X-ray at discharge. No adverse effects related to the procedure were recorded during the follow-up. CONCLUSIONS: The use of autologous MSCs for prevention of PAL in patients with high risk of PAL is feasible, safe and potentially effective. TRIAL REGISTRATION NO: EudraCT: 2013-000535-27. CLINICALTRIALS: gov idenfier: NCT02045745.

The SUPER reporting guideline suggested for reporting of surgical technique.

Background: Existing reporting guidelines pay insufficient attention to the detail and comprehensiveness reporting of surgical technique. The Surgical techniqUe rePorting chEcklist and standaRds (SUPER) aims to address this gap by defining reporting standards for surgical technique. The SUPER guideline intends to apply to articles that encompass surgical technique in any study design, surgical discipline, and stage of surgical innovation. Methods: Following the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network approach, 16 surgeons, journal editors, and methodologists reviewed existing reporting guidelines relating to surgical technique, reviewed papers from 15 top journals, and brainstormed to draft initial items for the SUPER. The initial items were revised through a three-round Delphi survey from 21 multidisciplinary Delphi panel experts from 13 countries and regions. The final SUPER items were formed after an online consensus meeting to resolve disagreements and a three-round wording refinement by all 16 SUPER working group members and five SUPER consultants. Results: The SUPER reporting guideline includes 22 items that are considered essential for good and informative surgical technique reporting. The items are divided into six sections: background, rationale, and objectives (items 1 to 5); preoperative preparations and requirements (items 6 to 9); surgical technique details (items 10 to 15); postoperative considerations and tasks (items 16 to 19); summary and prospect (items 20 and 21); and other information (item 22). Conclusions: The SUPER reporting guideline has the potential to guide detailed, comprehensive, and transparent surgical technique reporting for surgeons. It may also assist journal editors, peer reviewers, systematic reviewers, and guideline developers in the evaluation of surgical technique papers and help practitioners to better understand and reproduce surgical technique. Trial Registration: https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-other-study-designs/#SUPER.

The SUPER reporting guideline suggested for reporting of surgical technique: explanation and elaboration.

Background: Surgical technique plays an essential role in achieving good health outcomes. However, the quality of surgical technique reporting remains heterogeneous. Reporting checklists could help authors to describe the surgical technique more transparently and effectively, as well as to assist reviewers and editors evaluate it more informatively, and promote readers to better understand the technique. We previously developed SUPER (surgical technique reporting checklist and standards) to assist authors in reporting their research that contains surgical technique more transparently. However, further explanation and elaboration of each item are needed for better understanding and reporting practice. Methods: We searched surgical literature in PubMed, Google Scholar and journal websites published up to January 2023 to find multidiscipline examples in various article types for each SUPER item. Results: We explain the 22 items of the SUPER and provide rationales item by item alongside. We provide 69 examples from 53 literature that present optimal reporting of the 22 items. Article types of examples include pure surgical technique, and case reports, observational studies and clinical trials that contain surgical technique. Examples are multidisciplinary, including general surgery, orthopaedical surgery, cardiac surgery, thoracic surgery, gastrointestinal surgery, neurological surgery, oncogenic surgery, and emergency surgery etc. Conclusions: Along with SUPER article, this explanation and elaboration file can promote deeper understanding on the SUPER items. We hope that the article could further guide surgeons and researchers in reporting, and assist editors and peer reviewers in reviewing manuscripts related to surgical technique.

Failure to rescue following anatomical lung resection. Analysis of a prospective nationwide database.

Background: Rescue failure has been described as an important factor that conditions postoperative mortality after surgical interventions. The objective of this study is to determine the incidence and main determinants of failure to rescue after anatomical lung resections. Methods: Prospective multicenter study that included all patients undergoing anatomical pulmonary resection between December 2016 and March 2018 and registered in the Spanish nationwide database GEVATS. Postoperative complications were classified as minor (grades I and II) and major (grades IIIa to V) according to the Clavien-Dindo standardized classification. Patients that died after a major complication were considered rescue failure. A stepwise logistic regression model was created to identify predictors of failure to rescue. Results: 3,533 patients were analyzed. In total, 361 cases (10.2%) had major complications, of which 59 (16.3%) could not be rescued. The variables associated with rescue failure were: ppoDLCO% (OR, 0.98; 95% CI, 0.96-1; p = 0.067), cardiac comorbidity (OR, 2.1; 95% CI, 1.1-4; p = 0.024), extended resection (OR, 2.26; 95% CI, 0.94-5.41; p = 0.067), pneumonectomy (OR, 2.53; 95 CI, 1.07-6.03; p = 0.036) and hospital volume <120 cases per year (OR, 2.53; CI 95%, 1.26-5.07; p = 0.009). The area under the curve of the ROC curve was 0.72 (95% CI: 0.64-0.79). Conclusion: A significant percentage of patients who presented major complications after anatomical lung resection did not survive to discharge. Pneumonectomy and annual surgical volume are the risk factors most closely related to rescue failure. Complex thoracic surgical pathology should be concentrated in high-volume centers to obtain the best results in potentially high-risk patients.

Impact of Age at the Time of the First ST-Elevation Myocardial Infarction on 10-Year Outcomes (from the EXAMINATION-EXTEND Trial).

The aim of this substudy of the EXAMINATION-EXTEND was to analyze 10-year outcomes according to the patient's age at the time of the first ST-elevation myocardial infarction (STEMI). Of 1,498 patients with STEMI included in the EXAMINATION-EXTEND study, those with a previous history of coronary ischemic even or ischemic stroke were excluded from this analysis. The remaining 1,375 patients were divided into 4 age groups: <55, 55 to 65, 65 to 75, and >75 years. The primary end point was 10-year patient-oriented composite end point (POCE) of all-cause death, any MI, or any revascularization. At 10-year follow-up, patients aged <55 years (adjusted hazard ratio [HR] 0.24, 95% confidence interval [CI] 0.18 to 0.31, p = 0.001), 55 to 65 years (adjusted HR 0.26, 95% CI 0.20 to 0.34, p = 0.001), and 65 to 75 years (adjusted HR 0.38, 95% CI 0.30 to 0.50, p = 0.001) showed lower risk of POCE than those aged >75 years, led by a lower incidence of all-cause death (<55 : 6% vs 55 to 65: 11.9% vs 65 to 75: 25.7% vs >75 years: 61.6%, p = 0.001). Cardiac death was more prevalent in the older group (<55: 3.7% vs 55 to 65: 5.8% vs 65 to 75: 10.9% vs >75 years: 35.5%, p = 0.001). In the landmark analyses, between 5- and 10-year follow-up, young patients exhibited a higher incidence of any revascularization (<55: 7.4% vs 55 to 65: 4.9% vs 65 to 75: 1.8% vs >65 years: 1.6%, p = 0.001). In conclusion, in patients with a first STEMI, advanced age was associated with high rates of POCE at 10-year follow-up due to all-cause and cardiac death. Conversely, younger patients exhibited a high risk of revascularization at long-term follow-up.