High-risk Surgical Patients Research Articles

PASCAL repair system for patients with mitral regurgitation: A systematic review

BackgroundTranscatheter edge-to-edge repair (TEER) of the mitral valve has emerged as the standard treatment for patients with mitral regurgitation (MR) with high surgical risk. Even though MitraClip is widely used, the novel PASCAL device system offers distinct technical features. We aim to study the safety and efficacy of the PASCAL repair system in clinically significant MR. MethodsPubMed, Medline, Cochrane Central Register of Controlled Trials, and EMBASE were searched for articles published from August 2016 until June 2022 to identify studies that investigated the safety and efficacy of PASCAL for patients with degenerative, functional and mixed MR. Primary performance endpoints were technical, device, and procedural successes. Primary safety endpoint was composite 30 day major adverse events (MAE). Secondary endpoints were MR grade at discharge and 30 days, 30 day postprocedural NYHA functional class, left ventricular ejection fraction (LVEF), change in 6-min walk distance (6MWD), 30-day and 12-month all-cause mortality. ResultsWe included twelve retrospective and prospective observational studies and one randomized controlled study consisting of 1028 patients with severe, symptomatic MR (NYHA III-IV: 84.0%, MR ≥ 3+: 99.7%) and high surgical risk (mean logistic EuroSCORE of 16.4).Technical success was 95.7%, procedural success was 95.2%, and device success was 86.1% relative to the weighted average. MR grade was ≤2+ in 94.7% of patients at discharge and 94.0% patients at 30-day follow-up. Mean 30-day and 12-month mortality after device implantation were 4.54% and 12.2%. ConclusionThe PASCAL repair system appears to be a safe and effective therapeutic option to treat severe, symptomatic MR in high surgical risk patients.

Preoperative cerebral oxygenation in high-risk noncardiac surgical patients: an observational study on postoperative mortality and complications

Near Infrared Spectroscopy (NIRS) has become widely accepted to evaluate regional cerebral oxygen saturation (rScO2), potentially acting as a surrogate parameter of reduced cerebral oxygen delivery or increased consumption. Low preoperative rScO2 is associated with increased postoperative complications after cardiac surgery. However, its universal potential in pre-anesthesia risk assessment remains unclear. Therefore, we investigated whether low preoperative rScO2 is indicative of postoperative complications and associated with poor outcomes in noncardiac surgical patients. We prospectively enrolled 130 patients undergoing high-risk noncardiac surgery. During pre-anesthesia evaluation, baseline rScO2 was recorded with and without oxygen supplementation. The primary endpoint was 30-day mortality, while secondary endpoints were postoperative myocardial injury, respiratory complications, and renal failure. We further evaluated the impact of body position and preoperative hemoglobin (Hb) concentration on rScO2. Of the initially enrolled 130 patients, 126 remained for final analysis. Six (4.76%) patients died within 30 postoperative days. 95 (75.4%) patients were admitted to the ICU. 32 (25.4%) patients suffered from major postoperative complications. There was no significant association between rScO2 and 30-day mortality or secondary endpoints. Oxygen supplementation induced a significant increase of rScO2. Furthermore, Hb concentration correlated with rScO2 values and body position affected rScO2. No significant association between rScO2 values and NYHA, LVEF, or MET classes were observed. Preoperative rScO2 is not associated with postoperative complications in patients undergoing high-risk noncardiac surgery. We speculate that the discriminatory power of NIRS is insufficient due to individual variability of rScO2 values and confounding factors.

Perioperative Haemodynamic Optimization Strategies in HighRisk Surgical Patients

Millions of surgical procedures are performed globally each year. High-risk surgical procedures have varying but generally, high mortality and morbidity rates, making them a global challenge. In order to lower the risk of postoperative morbidity and mortality, perioperative haemodynamic optimization strategies have been designed. They are also referred to as goal-directed therapy. These guidelines for managing high-risk surgical patients propose strict adherence to values of mean arterial pressure not to fall below 65 mmHg during surgery, as mean arterial pressure significantly influences organ perfusion. It is recommended to utilize dynamic indicators to guide fluid administration in a substantial portion of non-cardiac surgery cases. However, it is advised to implement a checklist of validity criteria prior to administering volume expansion, acknowledging the recognized limitations of these indices. To tailor fluid therapy appropriately for individual patients and prevent fluid overload, it is commonly recommended to employ minimally invasive or non-invasive monitoring of stroke volume/cardiac output, particularly for patients undergoing moderate- to high-risk surgeries. Furthermore, these strategies suggest combining fluid administration with vasoconstrictors to sustain optimal blood flow and maintain perfusion pressure above hazardous thresholds. Incorporating personalized hemodynamic optimization approaches to reduce postoperative complications, shorten hospital stays, and ultimately prevent mortality in high-risk surgical patients has become a crucial aspect of standard surgical care. This review aims to assess strategies for optimizing perioperative hemodynamics in high-risk surgical patients.

Aorta to Right Ventricular Fistula Status Post-TAVR.

Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure that involves replacing a damaged aortic valve using a catheter, typically inserted through a small incision in the leg, leading to faster recovery and reduced risks compared with traditional open-heart surgery. It is a common procedure; however, it is not without adverse events. We report a case of an 83-year-old man who underwent TAVR for the indication of severe symptomatic aortic stenosis. Shortly thereafter, he complained of progressive shortness of breath and was hospitalized for acute on chronic heart failure. Transesophageal echocardiography (TEE) was the first indication of a potential aorta to right ventricular fistula, and this was confirmed by a cardiac computed tomography angiography (CTA). He underwent a period of medical observation but did not do well, requiring re-admission to the hospital for acute on chronic heart failure. He was ultimately treated by percutaneous low-profile shunt closure using a septal occluder device. Percutaneous shunt closure in symptomatic patients using percutaneous low-profile shunt closure devices seems to be the best treatment option in high surgical risk patients.

Transcatheter Mitral Valve Replacement in Patients with Mitral Annular Calcification: A Review.

Mitral annular calcification (MAC) is a progressive degenerative calcification of the mitral valve (MV) that is associated with mitral stenosis, regurgitation or both. Patients with MAC are poor candidates for MV surgery because of technical challenges and high peri-operative mortality. Transcatheter MV replacement (TMVR) has emerged as an option for such high surgical risk patients. This has been described with the use of the SAPIEN transcatheter heart valve (valve-in-MAC) and dedicated TMVR devices. Careful anatomic assessment is important to avoid complications of TMVR, such as left ventricular outflow tract obstruction, valve migration, embolization and paravalvular mitral regurgitation. In this review, we discuss the pathology, importance of preprocedural multimodality imaging for optimal patient selection, clinical outcomes and complications associated with TMVR in patients with MAC.

Change in Left Ventricular Ejection Fraction after Transcatheter Aortic Valve Replacement in Severe Aortic Stenosis

Background: Long-standing aortic stenosis (AS) leads to elevated left ventricular (LV) pressure and as a consequence develops LV hypertrophy and increased myocardial fibrosis. The LV ejection fraction (LVEF) remains often preserved until the late stages of disease, but subtle LV dysfunction can be present in patients of severe AS. Transcatheter aortic valve replacement (TAVR) has become the primary method of aortic valve replacement for intermediate and high surgical risk patients with AS. In this study, we aimed to see if TAVR in patients with severe AS can result in the improvement of systolic functions. Subjects and Methods: We retrospectively studied the data of 52 consecutive symptomatic patients with severe symptomatic AS who underwent TAVR at our center. Echocardiography was performed at baseline and 6 months after the procedure to evaluate change in LVEF. Results: Fifty-two patients were retrospectively evaluated. The mean LVEF before TAVR was 49.52 ± 13.44. The mean LVEF after TAVR was 52.02 ± 10.95. That means there was a significant increase in LVEF after TAVR as compared to LVEF before TAVR (P = 0.008 using Wilcoxon signed-rank test). Conclusion: In this article, we conclude that, in AS patients, the removal of afterload by TAVR significantly improves cardiac functions as assessed by LVEF.

Optimisation of the high-risk thoracic surgical patient: a narrative review

Optimisation of the high-risk thoracic surgical patient: a narrative review

Internal medicine consultation for high-risk surgical patients: reflection on hospital mortality and readmission rates in a low-income country.

The objective of this study was to assess the impact of internal medicine consultation on mortality, 30-day readmission, and length of stay in surgical patients. This is a retrospective descriptive study developed in a public Brazilian teaching hospital with 850 beds. A total of 70,245 patients were admitted from 2010 to 2018 to the surgery departments. The main outcomes measured were patients' mortality, 30-day readmission, and length of stay. Mortality of high-risk patients was lower when followed by internal medicine consultation: patients with ASA≥3 (RR 0.89 [95% confidence interval (95%CI) 0.80-0.99], p=0.02), patients with ASA≥3 plus≥65 years (RR 0.88 [95%CI 0.78-0.99], p=0.04), patients with ASA≥3 plus high-risk surgery (RR 0.86 [95%CI 0.77-0.97], p=0.01), and patients with ASA≥4 plus age ≥65 years (RR 0.83 [95%CI 0.72-0.96], p=0.01). The 30-day readmission of high-risk patients was lower when followed by internal medicine consultation: patients with ≥65 years (RR 0.57 [95%CI 0.37-0.89], p=0.01) and patients with high-risk surgery (RR 0.63 [95%CI 0.46-0.57], p=0.005). The Poisson multivariate regression with adjustment in variances showed that all the variables (namely, age, ASA, morbidity index, surgery risk, and internal medicine consultation) were associated with higher mortality of patients; however, internal medicine consultation was associated with a reduction of mortality in high-risk patients (RR 0.72 [95%CI 0.65-0.84], p=0.02) and an increase of mortality in low-risk patients (RR 1.55 [95%CI 1.31-1.67], p=0.01). High-risk surgical patients may benefit from perioperative internal medicine consultations, which probably decrease hospital mortality and 30-day hospital readmission.

ACUTE CHOLECYSTITIS IN HIGH-RISK PATIENTS. SURGICAL, RADIOLOGICAL, OR ENDOSCOPIC TREATMENT? BRAZILIAN COLLEGE OF DIGESTIVE SURGERY POSITION PAPER.

Acute cholecystitis (AC) is an acute inflammatory process of the gallbladder that may be associated with potentially severe complications, such as empyema, gangrene, perforation of the gallbladder, and sepsis. The gold standard treatment for AC is laparoscopic cholecystectomy. However, for a small group of AC patients, the risk of laparoscopic cholecystectomy can be very high, mainly in the elderly with associated severe diseases. In these critically ill patients, percutaneous cholecystostomy or endoscopic ultrasound gallbladder drainage may be a temporary therapeutic option, a bridge to cholecystectomy. The objective of this Brazilian College of Digestive Surgery Position Paper is to present new advances in AC treatment in high-risk surgical patients to help surgeons, endoscopists, and physicians select the best treatment for their patients. The effectiveness, safety, advantages, disadvantages, and outcomes of each procedure are discussed. The main conclusions are: a) AC patients with elevated surgical risk must be preferably treated in tertiary hospitals where surgical, radiological, and endoscopic expertise and resources are available; b) The optimal treatment modality for high-surgical-risk patients should be individualized based on clinical conditions and available expertise; c) Laparoscopic cholecystectomy remains an excellent option of treatment, mainly in hospitals in which percutaneous or endoscopic gallbladder drainage is not available; d) Percutaneous cholecystostomy and endoscopic gallbladder drainage should be performed only in well-equipped hospitals with experienced interventional radiologist and/or endoscopist; e) Cholecystostomy catheter should be removed after resolution of AC. However, in patients who have no clinical condition to undergo cholecystectomy, the catheter may be maintained for a prolonged period or even definitively; f) If the cholecystostomy catheter is maintained for a long period of time several complications may occur, such as bleeding, bile leakage, obstruction, pain at the insertion site, accidental removal of the catheter, and recurrent AC; g) The ideal waiting time between cholecystostomy and cholecystectomy has not yet been established and ranges from immediately after clinical improvement to months. h) Long waiting periods between cholecystostomy and cholecystectomy may be associated with new episodes of acute cholecystitis, multiple hospital readmissions, and increased costs. Finally, when selecting the best treatment option other aspects should also be considered, such as costs, procedures available at the medical center, and the patient's desire. The patient and his family should be fully informed about all treatment options, so they can help making the final decision.

Long-term outcomes of endoscopic ultrasound-guided gallbladder drainage versus insitu or ex situ percutaneous gallbladder drainage in real-world practice.

Many studies showed better outcomes of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) when compared with percutaneous transhepatic gallbladder drainage (P-GBD) in which most tubes were left insitu. However, no studies have directly compared EUS-GBD with P-GBD after tube removal (ex situ). We compared the long-term outcomes of EUS-GBD and ex situ or insitu P-GBD in high surgical risk patients with acute cholecystitis. We reviewed the records of 182 patients (EUS-GBD, n=75; P-GBD, n=107) who underwent gallbladder drainage. The procedural outcomes, long-term outcomes, and adverse events were compared. The EUS-GBD group and the P-GBD group had similar rates of technical and clinical success. Early adverse events were less common in the EUS-GBD group (5.5% vs. 18.9%, P=0.010). The long-term outcomes were evaluated in 168 patients (EUS-GBD, n=67; P-GBD ex situ, n=84; P-GBD insitu, n=17). The rate of cholecystitis recurrence in the EUS-GBD group (6.0%) was similar to that in the P-GBD ex situ group (9.6%, P=0.422), but significantly lower than that in the P-GBD insitu group (23.5%, P=0.049). P-GBD insitu was a significant predictor of recurrent cholecystitis (hazard ratio 14.6; 95% confidence interval 2.9-72.8). The long-term recurrence rate of acute cholecystitis in patients who underwent EUS-GBD was comparable to that in patients whose P-GBD could be removed. However, patients in whom P-GBD could not be removed showed higher rates of recurrent cholecystitis than patients with EUS-GBD.

Physiologic risk factors increase risk of myocardial infarction with transcarotid artery revascularization in prospective trials

ObjectivePatients can be considered at high risk for carotid endarterectomy (CEA) because of either anatomic or physiologic factors and will often undergo transcarotid artery revascularization (TCAR). Patients with physiologic criteria will be considered to have a higher overall surgical risk because of more significant comorbidities. Our aim was to study the incidence of stroke, myocardial infarction (MI), death, and combined end points for patients who had undergone TCAR stratified by the risk factors (anatomic vs physiologic). MethodsAn analysis of prospectively collected data from the ROADSTER (pivotal; safety and efficacy study for reverse flow used during carotid artery stenting procedure), ROADSTER 2 (Food and Drug Administration indicated postmarket trial; postapproval study of transcarotid artery revascularization in patients with significant carotid artery disease), and ROADSTER extended access TCAR trials was performed. All 851 patients were considered to be at high risk for CEA and were included and stratified using high-risk anatomic criteria (ie, contralateral occlusion, tandem stenosis, high cervical artery stenosis, restenosis after previous endarterectomy, bilateral carotid stenting, hostile neck anatomy with previous neck irradiation, neck dissection, cervical spine immobility) or high-risk physiologic criteria (ie, age >75 years, multivessel coronary artery disease, history of angina, congestive heart failure New York Heart Association class III/IV, left ventricular ejection fraction <30%, recent MI, severe chronic obstructive pulmonary disease, permanent contralateral cranial nerve injury, chronic renal insufficiency). For trial inclusion, asymptomatic patients were required to have had ≥80% carotid stenosis and symptomatic patients to have had ≥50% stenosis. The primary outcome measures were stroke, death, and MI at 30 days. The data were statistically analyzed using the χ2 test, as appropriate. ResultsA total of 851 high surgical risk patients were categorized into two groups: those with anatomic-only risk factors (n = 372) or at least one physiologic risk factor present (n = 479). Of the 851 patients, 74.5% of those in the anatomic subset were asymptomatic, and 76.6% in the physiologic subset were asymptomatic. General anesthesia was used similarly in both groups (67.7% anatomic vs 68.1% physiologic). MI had occurred in eight patients in the physiologic group (1.7%), all of whom had been asymptomatic and in none of the anatomic patients (P = .01). The combined stroke, death, and MI rate was 2.1% in the anatomic cohort and 4.2% in the physiologic cohort (P = .10). Stratification of each group into asymptomatic and symptomatic patients did not yield any further differences. ConclusionsThe patients who had undergone TCAR in the present prospective, neurologically adjudicated trial because of high-risk physiologic factors had had a higher rate of MI compared with the patients who had qualified for TCAR using anatomic criteria only. These patients had experienced comparable rates of combined stroke, death, and MI rates. The anatomic patients represented a healthier and younger subset of patients, with notably low overall event rates.

Mid-term results of open transaortic implantation of the «MedLab-CT» prosthesis: prospective clinical study

Aim. To evaluate the mid-term clinical and hemodynamic results of open transaortic implantation of the balloon-expandable prosthesis MedLab-CT in patients with high surgical risk.&#x0D; Material and methods. The study included 41 patients (mean age 65.711.7 years) who underwent open implantation of the MedLab-CT (MedInzh, Russia) aortic valve (AV) prosthesis under cardiopulmonary bypass and cardioplegia, belonging to the cohort of high surgical risk according to the data EuroSCORE II scale, with critical symptomatic aortic stenosis, high functional class according to the classification of the New York Heart Association (NYHA). All studied patients had clinical indications for transcatheter AV replacement, however, given the concomitant surgical pathology of the heart (critical multivessel coronary artery disease unsuitable for endovascular treatment and/or damage to other valves), as well as the morphological features of the aortic root (low location coronary artery ostia relative to the annulus fibrosus of the AV, large calcifications of the coronary cusps according to computed tomography, with a high risk of ostium occlusion), they were denied a minimally invasive procedure. The incidence of adverse clinical events and hemodynamic parameters of the AV prosthesis in the medium-term period were assessed.&#x0D; Results. The average follow-up period was 13.1 months, the maximum was 3 years. Mortality 2.4% (n=1), there were no cases of stroke. The average gradient in the long-term period on AK MedLab-CT is 8.53.1 mm Hg. Paravalvular regurgitation above grade 2 and transvalvular regurgitation were not detected. Thus, no cases of dysfunction of the aortic prosthesis were noted.&#x0D; Conclusion. In the medium term, satisfactory clinical and hemodynamic results of open implantation of the MedLab-CT balloon-expandable prosthesis were obtained in high surgical risk patients.

Efficacy of Off-Pump Coronary Artery Bypass Grafting with Concomitant Transcatheter Aortic Valve Replacement.

This study aimed to evaluate the early and intermediate-term outcomes of patients who underwent concomitant off-pump coronary artery bypass grafting (CABG) and transcatheter aortic valve replacement (TAVR). Between January 2014 and June 2021, 49 patients underwent concomitant off-pump CABG and TAVR via median sternotomy (TAVRCAB group) and 143 underwent concomitant on-pump CABG and surgical aortic replacement. Of the 143 patients who underwent on-pump surgery, 80 (SAVRCAB group) were eligible for comparison. The composite event included all-cause death, heart failure rehospitalisation, repeat revascularisation, brain infarction, and repeat aortic valve replacement. The Society of Thoracic Surgeons' predicted risk for mortality and age were higher in the TAVRCAB group than in the SAVRCAB group (7.1% vs 3.1% [p<0.001]; 81 years vs 75 years [p<0.001], respectively), while the surgical time was shorter (289 min vs 352 min; p<0.001). There was no conversion to on-pump surgery in the TAVRCAB group. The postoperative maximum creatinine kinase-MB value was lower in the TAVRCAB group. There was no deep sternal wound infection or repeat revascularisation in either group. Hospital death and brain infarction developed in one patient (1.3%) each in the SAVRCAB group, but in no patients in the TAVRCAB group. The rates of freedom from the composite event were similar between the two groups during the follow-up period. Concomitant off-pump CABG and TAVR would be a less-invasive alternative procedure for treating intermediate or high surgical risk patients with aortic stenosis and coronary artery disease unsuitable for percutaneous coronary intervention.

A Cost-Effectiveness Analysis of Prehabilitation for High-Risk Surgical Patients in Canada: Results from a Nonrandomized Clinical Trial

<h3>Research Objectives</h3> To evaluate the cost-effectiveness of a pragmatic model of prehabilitation for high-risk surgical candidates from a hospital perspective. <h3>Design</h3> A cost-effectiveness analysis (CEA) from a hospital perspective was performed using data from a nonrandomized clinical trial of a pragmatic model of prehabilitation compared to usual care (UC) for high-risk surgical patients. <h3>Setting</h3> A large academic hospital in Toronto, Ontario, Canada. <h3>Participants</h3> High-risk surgical candidates referred by their physician at the time of surgical planning. <h3>Interventions</h3> The prehabilitation group underwent baseline assessments from a multidisciplinary healthcare team followed by shared-decision making concerning allocation to facility-based, home-based, or virtual prehabilitation. Prehabilitation modalities included individualized exercise, nutrition, psychological support, and smoking cessation over the preoperative period. The control group received UC. <h3>Main Outcome Measures</h3> The primary endpoint was an incremental cost-effectiveness ratio (ICER) with surgical complications as the effect measure. Nonparametric bootstrapping methods were employed to investigate the joint distribution of incremental costs and incremental effects, estimate ICER uncertainty, and generate cost-effectiveness acceptability curves (CEACs). Results were presented for overall prehabilitation and stratified by each prehabilitation delivery strategy. <h3>Results</h3> Sixty-seven patients were included (prehabilitation n=49; UC n=18). Prehabilitation was associated with averting more surgical complications but came at greater costs compared to UC. Results indicate the potential cost-effectiveness of prehabilitation for reducing surgical complications, although data limitations and point-estimate uncertainty preclude conclusive recommendations. When stratified by prehabilitation delivery strategy, estimated cost-effectiveness varied considerably, and beckon future research to clarify economically optimal prehabilitation protocols within an implementation context. <h3>Conclusions</h3> This was the first CEA of a pragmatic model of prehabilitation for high-risk surgical patients, contributing an increasingly relevant economic perspective regarding the potential role of prehabilitation implementation from a hospital perspective. Future economic evaluations of prehabilitation are necessary to clarify optimal prehabilitation protocols and definitively inform implementation decisions. <h3>Author(s) Disclosures</h3> No disclosures.

ODP060 Treatment of Aldosterone-producing adenoma by CT-guided radiofrequency ablation in a high surgical risk patient: biochemical and clinical outcomes.

Abstract Background Primary aldosteronism (PA) is a leading cause of secondary hypertension and harness a much higher cardiovascular risk than essential hypertension. About 30% of PA cases are due the existence of an aldosterone-producing adenoma (APA). Although the current guidelines recommend unilateral laparoscopic adrenalectomy as the standard treatment of APA, some patients might no be suited for the procedure. Clinical Case A 66-year man was referred to our institution following a 14-year history of resistant hypertension. His past history included a stage III chronic kidney disease, type 2 diabetes mellitus, dyslipidemia, obstructive sleep apnea (OSA), hypothyroidism, grade I obesity, and rheumatoid arthritis. Initial tests were consistent with PA: elevated serum aldosterone (26 ng/dL), suppressed plasma renin activity (PRA: 0. 07 ng/ml/H) and a high aldosterone/renin ratio (RAR: 65) with concomitant hypokalemia (3,4 mEq/L). Abdominal CT-scan demonstrated a 11×8 mm left adrenal nodule with an absolute washout of 60%. A diagnosis of an APA was confirmed by an adrenal vein sampling. Since the patient had multiple comorbidities and an unequivocal high surgical risk, laparoscopic adrenalectomy was contraindicated, and pharmacologic treatment was started with spironolactone. Despite the use of high doses of spironolactone, blood pressure (BP) control was not achieved. Moreover, severe side effects were experienced, notably sexual dysfunction and painful gynecomastia. In this setting, a decision for a CT-guided radiofrequency ablation was made. The procedure underwent under general anesthesia and had no adverse events. Three days after the ablation, biochemical analysis demonstrated a significant reduction of aldosterone (10 ng/dL) and RAR (10), whereas the PRA was notably higher (1,45 ng/mL/h). He transitioned from 6 different classes of anti-hypertensives drugs to only one and his blood pressure was well controlled in an appointment 30 days after the procedure. On the other hand, his glomerular filtration rate had decayed from 44 mL/min to 31 mL/h due to a rapid blood pressure control. Despite no changes in anthropometric measures and OSA related symptoms were observed, an expressive reduction in microalbuminuria (191 mg/dL to 28,6 mg/dL) was noticed. Conclusion The CT-guided radiofrequency ablation is a suitable minimally invasive treatment for PA in high surgical risk patients. For patients with high surgical risk and intolerance to clinical treatment, radiofrequency should be offered as an option for treatment in a specialized center. Presentation: No date and time listed

Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Low-risk Patients: A Meta-Analysis Based on a 2-Year Follow-Up.

Previous studies have shown that transcatheter aortic valve implantation is the best alternative therapy to surgical aortic valve replacement in high-risk surgical patients with aortic stenosis. However, it is not clear whether transcatheter aortic valve implantation can be utilized in low-risk surgical patients with aortic stenosis. This studyaimed to evaluate the safety and efficacy of transcatheter aortic valve implantation in low-risk patients. From the outset of our initiative until April 2022, PubMed, EMBASE, and the Cochrane database were thoroughly searched, yielding the selection of 3 randomized controlled trials including 2644 patients with aortic stenosis, to assess outcome measures at distinct follow-up time. The mean Society of Thoracic Surgeons Predicted Risk of Mortality score of patients was 2.2. At the 30-day and 1-year follow-up, transcatheter aortic valve implan- tation was associated with a lower incidence of all-cause mortality, cardiovascular mor- tality, acute kidney injury (stage 2 or 3), life-threatening or significant bleeding, and new atrial fibrillation but an increased risk of permanent pacemaker implantation. At the 2-year follow-up, transcatheter aortic valve implantation only had an advantage in new atrial fibrillation (relative risk, 0.27; 95% CI, 0.14-0.51; P &lt; .0001), with no significant differ- ence in all-cause mortality or cardiovascular mortality. For low-risk surgical patients with aortic stenosis, compared to surgical aortic valve replacement, transcatheter aortic valve implantation was associated with lower all-cause mortality at 30-day follow-up and lower cardiovascular mortality at 1-year follow-up. Except for the advantages in new atrial fibrillation, transcatheter aor- tic valve implantation had no significant impact on mortality at 2-year follow-up.

A Thoracic Surgery–Specific Risk Assessment Model to Prevent Perioperative Venous Thromboembolism

BackgroundThe risk of venous thromboembolism (VTE) in patients undergoing resection in the setting of lung cancer represents a major challenge to improving postoperative outcomes. The Caprini risk assessment model has been validated in general surgery to determine a role for extended chemoprophylaxis to reduce VTE events. Our goal was to simplify this burdensome model for the unique needs of this thoracic surgical population to better guide anticoagulation decision-making. MethodsPatients who underwent a resection for lung malignant neoplasm at our institution between June 2005 and June 2013 with available 60-day postoperative follow-up data were evaluated. Exclusion criteria were long-term anticoagulation, inferior vena cava filter, missing data, and loss to follow-up. Twelve selected risk factors were analyzed for each patient by logistic regression with stepwise inclusion to model 60-day VTE incidence. ResultsThere were 225 patients eligible for inclusion, and a VTE incidence of 5.8% was observed. We generated a 5-variable model with predictive ability for VTE occurrence similar to that of the Caprini risk assessment model (P = .29). Weighting of sex, age, history of VTE, surgical approach, and duration of procedure provides a low-risk or high-risk composite score with 56% sensitivity and 77% specificity. ConclusionsIn this effort to model VTE incidence on the basis of a limited set of clinical risk factors, we demonstrated efficacy of retrospectively scoring patients with just 5 data points in anticipating risk of postoperative VTE. These high-risk surgical patients can be readily identified in the preoperative period to benefit from extended postoperative prophylaxis.

Contact X-Ray Brachytherapy for Early Rectal Cancer: A Review of Outcomes From a Single UK Centre

AimsColorectal cancer is the fourth most prevalent cancer in the UK. Fortunately, with modern surveillance programmes, more patients are being diagnosed at an earlier stage. Although surgical excision remains the gold standard, many patients have co-morbidities that preclude them from having radical surgery. Additionally, a number of patients do not wish to live with a permanent colostomy. Radiotherapy has an established role in the non-surgical treatment of patients with rectal cancer. Increasing the radiation dose to the tumour increases the chance of local control. Using contact X-ray brachytherapy (CXB) it is possible to escalate the dose to the tumour and minimise the dose received by surrounding normal tissues. The aim of this study was to evaluate the outcomes of patients from our centre who have undergone CXB with or without external beam radiotherapy. Materials and methodsA prospectively maintained and locally managed colorectal database was used to collect clinical details and outcomes for colorectal cancer patients. All patients who were treated with CXB at our institution from the commencement of the service in April 2014 to the end of December 2019 were analysed. There was a minimum of 18 months of follow-up. ResultsOne hundred and ninety-three patients received at least one fraction of CXB. The median age at first treatment was 72 years (range 33–103 years). Seventy-three per cent of patients were male. Of the operable or high surgical risk patients, 105 were treated radically with radiotherapy, 28 were treated radically with radiotherapy after local resection and 22 patients were medically unfit for surgery. Most patients received external beam radiotherapy 45 Gy/25 fractions (87/146) or 25 Gy in five fractions (35/146). Forty-seven patients received CXB as sole treatment (51% had previous radiotherapy). Of those with a response assessment, with a median follow-up of 35 months, 78% of all patients achieved a clinical complete response (cCR) or a near cCR, 6% had a partial response and 16% had persistent disease. Of 154 radically treated patients with a response assessment, 84% achieved cCR or near cCR, 19% (24/129) of these subsequently relapsed. ConclusionThis series shows that CXB is a well-tolerated and effective treatment in a diverse cohort of patients with rectal cancer. Comparable favourable oncological outcomes were seen, in keeping with previously published work.

Factors associated with hospitalization for aortic stenosis in Portugal from 2015 to 2017

Abstract Background Severe aortic stenosis prevalence has been growing worldwide and constitutes a public health challenge. The gold-standard treatment is Surgical Aortic Valve Replacement (SAVR) however Transcatheter Aortic Valve Implantation (TAVI) has been increasing, especially in high-risk surgical patients. This study aims identifying the factors associated to the implementation of TAVI to minimize possible disparities in access to health services. Methods This study used data on inpatient discharges from the Portuguese NHS, from 2015 to 2017. SAVR and TAVI, were classified according to the International Classification of Diseases (ICD). Chi-square test and independent T-tests with 1% significance level in the SPSS® were performed to identify the factors associated with both interventions. Results A total of 8398 hospitalizations were analysed, 88.5% SAVR and 11.5% TAVI. The mean (SD) age for SAVR was 70 (±11) years old and 81 (±7) years old for TAVI (p &amp;lt; 0.001), 56.9% were male among SAVR and 44.6% among TAVI (p &amp;lt; 0.001). Year (p &amp;lt; 0.001), type of admission (p &amp;lt; 0.001), geographic location (p &amp;lt; 0.001), severity (p &amp;lt; 0.001) and Charlson Comorbidity Index (CCI) (p &amp;lt; 0.001) were associated with the type of intervention. Conclusions TAVI was performed in more severe patients and there was an increase in TAVI over the years, which is consistent with the growing use of the technology among other patients, e.g., the high-risk surgical patients. We also found a geographic pattern in the use of SAVR and TAVI. This might reveal the existence of geographic disparities regarding availability and access to health services. Key messages • In Portugal, there is an increase in the performance of TAVI, with geographical concentration that reflects on access. • TAVI is more often performed in more severe patients as an alternative to SAVR with similar discharge outcomes.

Patient–Specific Immersed Finite Element–Difference Model of Transcatheter Aortic Valve Replacement

Transcatheter aortic valve replacement (TAVR) first received FDA approval for high-risk surgical patients in 2011 and has been approved for low-risk surgical patients since 2019. It is now the most common type of aortic valve replacement, and its use continues to accelerate. Computer modeling and simulation (CM&S) is a tool to aid in TAVR device design, regulatory approval, and indication in patient-specific care. This study introduces a computational fluid-structure interaction (FSI) model of TAVR with Medtronic’s CoreValve Evolut R device using the immersed finite element-difference (IFED) method. We perform dynamic simulations of crimping and deployment of the Evolut R, as well as device behavior across the cardiac cycle in a patient-specific aortic root anatomy reconstructed from computed tomography (CT) image data. These IFED simulations, which incorporate biomechanics models fit to experimental tensile test data, automatically capture the contact within the device and between the self-expanding stent and native anatomy. Further, we apply realistic driving and loading conditions based on clinical measurements of human ventricular and aortic pressures and flow rates to demonstrate that our Evolut R model supports a physiological diastolic pressure load and provides informative clinical performance predictions.