Effect of Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement on All-Cause Mortality in Patients With Aortic Stenosis: A Randomized Clinical Trial.

Importance: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement and is the treatment of choice for patients at high operative risk. The role of TAVI in patients at lower risk is unclear. Objective: To determine whether TAVI is noninferior to surgery in patients at moderately increased operative risk. Design, Setting, and Participants: In this randomized clinical trial conducted at 34 UK centers, 913 patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014 and April 2018 and followed up through April 2019. Interventions: TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgical aortic valve replacement (surgery; n = 455). Main Outcomes and Measures: The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the 1-sided 97.5% CI for the absolute between-group difference in mortality. There were 36 secondary outcomes (30 reported herein), including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation. Results: Among 913 patients randomized (median age, 81 years [IQR, 78 to 84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0% to 3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of -2.0% (1-sided 97.5% CI, -∞ to 1.2%; P < .001 for noninferiority). Of 30 prespecified secondary outcomes reported herein, 24 showed no significant difference at 1 year. TAVI was associated with significantly shorter postprocedural hospitalization (median of 3 days [IQR, 2 to 5 days] vs 8 days [IQR, 6 to 13 days] in the surgery group). At 1 year, there were significantly fewer major bleeding events after TAVI compared with surgery (7.2% vs 20.2%, respectively; adjusted hazard ratio [HR], 0.33 [95% CI, 0.24 to 0.45]) but significantly more vascular complications (10.3% vs 2.4%; adjusted HR, 4.42 [95% CI, 2.54 to 7.71]), conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%; adjusted HR, 2.05 [95% CI, 1.43 to 2.94]), and mild (38.3% vs 11.7%) or moderate (2.3% vs 0.6%) aortic regurgitation (adjusted odds ratio for mild, moderate, or severe [no instance of severe reported] aortic regurgitation combined vs none, 4.89 [95% CI, 3.08 to 7.75]). Conclusions and Relevance: Among patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery with respect to all-cause mortality at 1 year. Trial Registration: isrctn.com Identifier: ISRCTN57819173.

Surgical treatment of atrial fibrillation in elderly patients undergoing high risk cardiac surgery.

BACKGROUND: Evaluating outcomes of concurrent Cox-Maze procedures in elderly patients undergoing high-risk cardiac surgery. MEHODS: We retrospectively identified patients aged over 70 years with Atrial Fibrillation (AF) from 2011 to 2017 who had two or more other cardiac procedures. They were subdivided into two groups: 1. Cox-Maze IV AF ablation. 2. No-Surgical AF treatment. A propensity match score was used to generate a homogeneous cohort and to eliminate confounding variables. Heart rhythm was assessed from Holter reports or 12-lead ECG. Follow-up data was collected through telephone consultations and medical records. RESULTS: There were 239 patients. Median follow up was 61 months. 70 patients had Cox-Maze IV procedures (29.3%). Demographic, intra- and post-operative outcomes were similar between groups although duration of pre-operative AF was shorter in Cox-Maze group (p = 0.001). There was no significant 30-day mortality difference in propensity matched cohorts (n = 84. P = 0.078). Sinus rhythm at annual and latest follow-up was 84.9% and 80.0% respectively in Maze group - 160 patients (66.9%) were alive at long-term follow-up with good survival outcomes in Cox Maze group. There was a high proportion of patients in NYHA 1 status in Cox-Maze group. No differences observed in freedom from stroke (p = 0.80) or permanent pacemaker (p = 0.33) between the groups. CONCLUSIONS: Surgical ablation is beneficial in elderly patients undergoing high-risk surgery - promoting excellent long-term freedom from AF and symptomatic / prognostic benefits, without added risk. Therefore, surgical risk should not be reason to deny benefits of concomitant AF-ablation. CLINICAL TRIAL REGISTRATION: Not required.

The assessment of lower extremity peripheral artery disease impact on body mass center disorders.

BACKGROUND: Lower extremity peripheral artery disease is a problem of contemporary medicine and along with the ischemic heart disease it is considered to be a civilization disease. The risk of the disease increases significantly within a group of people reaching the age of 55 years and is closely related to co-occurring hazardous factors, such as diabetes, hyperlipidemia, hypertension or tobacco smoking. The first symptom reported by patients is intermittent claudication. Such symptoms may indicate that lower extremity peripheral artery disease does have an impact on posture disorders and motor skills. METHODS: The study covered four stages. The first stage involved medical interviews to obtain information regarding anthropometry, age, motor organ surgery, concomitant diseases and the lifestyle. In the following stage the value of the ankle brachial index for both lower limbs were calculated. In case of symptomatic patients, additionally, the location of artery stenosis/aortoiliac section, was verified. The third stage involved using a dynamometric platform for determination of the body mass center position for both studied groups. In the fourth stage a treadmill walk test was used to assess the participants for intermittent claudication. FINDINGS: Based on the obtained results, an attempt was taken to observe the relationship between the clinical characteristics of the disease and the body mass center position deviations. INTERPRETATION: The attempt was undertaken to assess whether the measurement of body mass center position might be a diagnostic parameter to evaluate the patient's condition and thus an indication for taking a decision for surgical treatment or rehabilitation.

Abrasion Wear Resistance of Polymer Constructional Materials for Rapid Prototyping and Tool-Making Industry.

The original test results of abrasive wear resistance of different type of construction polymer materials were presented and discussed in this article. Tests were made on an adapted test stand (surface grinder for form and finish grinding). Test samples were made of different types of polymer board materials including RenShape®, Cibatool® and phenolic cotton laminated plastic laminate (TCF). An original methodology based on a grinding experimental set-up of abrasion wear resistance of polymer construction materials was presented. Equations describing relations between material type and wear resistance were presented and discussed. Micro and macro structures were investigated and used in wear resistance prediction.

Transcatheter aortic valve implantation in decompensated aortic stenosis within the same hospital admission: early clinical experience.

Objective: Severe decompensated aortic valve stenosis is associated with noticeable reduction in survival. Until recently the options for such patients were either high-risk surgery or percutaneous balloon valvuloplasty and medical therapy which does not add any survival benefits and associated with high rate of complications. We present our experience in the use of transcatheter aortic valve implantation (TAVI) in patients with decompensated severe aortic stenosis requiring urgent intervention in the same hospital admission. Methods: In this observational study, all patients who were admitted with decompensated severe aortic stenosis were enrolled. Elective patients were excluded from the study. Perioperative records were analysed and clinical, echocardiographic and survival data were presented. Results: 76 patients with a mean age of 81±6 years were enrolled. All patients presented with New York Heart Association (NYHA) IV status. Femoral approach was performed in 86.8%. Median postoperative hospital stay was 6 days and intensive care unit admission rate was 15%. At follow-up, 61.8% of patients were in NYHA status I/II. Moderate or more paravalvular leak occurred in 5.2% of patients. Permanent pacemaker was required in 14.4% of patients. The incidence of in-hospital death was 2.6%. Kaplan-Meier analysis indicated a survival rate of 81% at 1 year. Conclusions: Urgent in-hospital TAVI is feasible as the first-line treatment in decompensated severe aortic stenosis. In our cohort, it showed to be safe and achieved satisfactory survival rates and symptom control.

A second arterial conduit to the circumflex circulation significantly improves survival after coronary artery bypass surgery.

OBJECTIVES: Conventional coronary artery bypass surgery involves the use of a single left internal mammary artery to the left anterior descending artery and saphenous vein grafts reserved for other sites. This retrospective propensity-matched study investigated the impact of a second arterial conduit to the left-sided circulation on early and long-term survival after coronary artery bypass surgery. METHODS: Data were retrospectively collected from 2004 to 2014 for all revascularizations with at least 1 arterial and/or 1 venous graft to the circumflex circulation, in addition to an internal mammary artery to the left anterior descending artery. Propensity-matched groups were created based on baseline characteristics. Hazard functions were estimated using Cox multivariable regression, and the Kaplan-Meier survival curves were compared between the matched cohorts. RESULTS: A total of 1226 patients with a venous conduit to the left-sided circulation were successfully matched to an equal number of patients with an arterial conduit. Regression analysis identified a second arterial conduit, logistic European System for Cardiac Operative Risk Evaluation score (EuroSCORE), pulmonary disease, left ventricular ejection fraction, New York Heart Association (NYHA) Class and previous myocardial infarction as significant predictors of survival. A second arterial graft to the left circumflex circulation was a predictor of improved survival (hazard ratio 0.64, 95% confidence interval 0.51-0.80; P < 0.001). There were significant early and late survival benefits (arterial vs venous: 98.2% vs 96.3%, P = 0.003 at 1 year; 82.4% vs 62.2%, P < 0.001 at 10 years) from a second arterial conduit to the circumflex circulation. CONCLUSIONS: There are significant early and late incremental survival benefits from a second arterial conduit to the circumflex circulation.

Does a third arterial conduit to the right coronary circulation improve survival?

BACKGROUND: The long-term benefits of a third arterial conduit to the right circulation in triple-vessel disease remain debatable. This retrospective, single-center, propensity-matched study investigates the impact of a third arterial conduit to the right circulation on early and intermediate survival after coronary artery bypass grafting. METHODS: Data were retrospectively collected from 2004 to 2014 for all surgical revascularizations for triple-vessel disease with at least 2 arterial conduits to the left circulation and a third arterial or venous conduit to the right circulation. A total of 167 pairs were propensity matched to arterial versus venous third conduit to right circulation. Hazard functions were obtained with Cox multivariate regression and Kaplan-Meier survival curves were compared between the matched cohorts. RESULTS: Extracardiac arteriopathy, logistic euroSCORE, and left main stem disease were significant predictors of adverse survival. A third arterial conduit to the right circulation was not a significant predictor of improved survival in multivariate analysis (HR, 0.72; 95% CI, 0.34-1.55; P = .411). 30-day mortality was 0.6% in both groups. There was no significant difference in early or intermediate survival in the propensity-matched groups (venous vs arterial, 99.2% vs 99.2%; P = 1.000 at 1 year; 85.2% vs 88.8%; P = .248 at 5 years and 69.2% vs 88.8%; P = .297 at 7 years) CONCLUSIONS: The use of a third arterial versus a venous conduit to the right circulation does not improve early or intermediate survival up to 7 years in triple-vessel coronary artery disease in this study. Longer follow-up and larger cohorts may be needed for differences to emerge.

Shelhigh no-react pulmonic valve conduit for pulmonary valve endocarditis.

Pulmonary valve endocarditis is uncommon, so experience of surgical treatment is limited. A case of pulmonary valve endocarditis in a 26-year-old man, with associated extension into the pulmonary valve annulus and vegetations in the main pulmonary artery, is described. This necessitated surgical excision of the main pulmonary artery and pulmonary valve including the root, annulus, and part of the right ventricular outflow tract. The defect was reconstructed with a Shelhigh No-React porcine pulmonic valve conduit.