Durability of bioprosthetic aortic valves in patients under the age of 60 years - Rationale and design of the international INDURE registry

Background: There is an ever-growing number of patients requiring aortic valve replacement (AVR). Limited data is available on the long-term outcomes and structural integrity of bioprosthetic valves in younger patients undergoing surgical AVR. Methods: The INSPIRIS RESILIA Durability Registry (INDURE) is a prospective, open-label, multicentre, international registry with a follow-up of 5 years to assess clinical outcomes of patients younger than 60 years who undergo surgical AVR using the INSPIRIS RESILIA aortic valve. INDURE will be conducted across 20-22 sites in Europe and Canada and intends to enrol minimum of 400 patients. Patients will be included if they are scheduled to undergo AVR with or without concomitant root replacement and/or coronary bypass surgery. The primary objectives are to 1) determine VARC-2 defined time-related valve safety at one-year (depicted as freedom from events) and 2) determine freedom from stage 3 structural valve degeneration (SVD) presenting as morphological abnormalities and severe haemodynamic valve degeneration at 5 years. Secondary objectives include the assessment of the haemodynamic performance of the valve, all stages of SVD, potential valve-in-valve procedures, clinical outcomes (in terms of New York Heart Association [NYHA] function class and freedom from valve-related rehospitalisation) and change in patient quality-of-life. Discussion: INDURE is a prospective, multicentre registry in Europe and Canada, which will provide much needed data on the long-term performance of bioprosthetic valves in general and the INSPIRIS RESILIA valve in particular. The data may help to gather a deeper understanding of the longevity of bioprosthetic valves and may expand the use of bioprosthetic valves in patients under the age of 60 years. Trial registration: ClinicalTrials.gov identifier: NCT03666741 (registration received September, 12th, 2018)

Concomitant ablation of atrial fibrillation in octogenarians: an observational study

<p>Abstract</p> <p>Background</p> <p>Cardiac surgery is increasingly required in octogenarians. These patients frequently present atrial fibrillation (AF), a significant factor for stroke and premature death. During the last decade, AF ablation has become an effective procedure in cardiac surgery. Because the results of concomitant AF ablation in octogenarians undergoing cardiac surgery are still not clear, we evaluated the outcome in these patients.</p> <p>Methods</p> <p>Among 200 patients undergoing concomitant AF ablation (87% persistent AF), 28 patients were ≥ 80 years (82 ± 2.4 years). The outcome was analysed by prospective follow up after 3, 6, 12 months and annually thereafter. Freedom from AF was calculated according to the Kaplan-Meier method.</p> <p>Results</p> <p>Octogenarians were similar to controls regarding AF duration (48 ± 63.2 versus 63 ± 86.3 months, n.s.) and left atrial diameter (49 ± 6.1 versus 49 ± 8.8 mm, n.s.), but differed in EuroSCORE (17.3 ± 10.93 versus 7.4 ± 7.31%, p < 0.001), prevalence of paroxysmal AF (25.0 versus 11.0%, p = 0.042) and aortic valve disease (67.8 versus 28.5%, p < 0.001). ICU stay (8 ± 16.9 versus 4 ± 7.2 days, p = 0.027), hospital stay (20 ± 23.9 versus 14 ± 30.8 days, p < 0.05), and 30-d-mortality (14.3 versus 4.6%, p = 0.046) were increased. After 12 ± 6.1 months of follow-up (95% complete), 14 octogenarians (82%) and 101 controls (68%, n.s.) were in sinus rhythm; 59% without antiarrhythmic drugs in either group (n.s.). Sinus rhythm restoration was associated with improved NYHA functional class and renormalization of left atrial size. Cumulative freedom from AF demonstrated no difference between groups. Late mortality was higher in octogenarians (16.7 versus 6.1%, p = 0.065).</p> <p>Conclusion</p> <p>Sinus rhythm restoration rate and functional improvement are satisfactory in octogenarians undergoing concomitant AF ablation. Hence, despite an increased perioperative risk, this procedure should be considered even in advanced age.</p

Durability of bioprosthetic aortic valves in patients under the age of 60 years - Rationale and design of the international INDURE registry

Background: There is an ever-growing number of patients requiring aortic valve replacement (AVR). Limited data is available on the long-term outcomes and structural integrity of bioprosthetic valves in younger patients undergoing surgical AVR. Methods: The INSPIRIS RESILIA Durability Registry (INDURE) is a prospective, open-label, multicentre, international registry with a follow-up of 5 years to assess clinical outcomes of patients younger than 60 years who undergo surgical AVR using the INS

Vascular relaxation of canine visceral arteries after ischemia by means of supraceliac aortic cross-clamping followed by reperfusion

<p>Abstract</p> <p>Background</p> <p>The supraceliac aortic cross-clamping can be an option to save patients with hipovolemic shock due to abdominal trauma. However, this maneuver is associated with ischemia/reperfusion (I/R) injury strongly related to oxidative stress and reduction of nitric oxide bioavailability. Moreover, several studies demonstrated impairment in relaxation after I/R, but the time course of I/R necessary to induce vascular dysfunction is still controversial. We investigated whether 60 minutes of ischemia followed by 30 minutes of reperfusion do not change the relaxation of visceral arteries nor the plasma and renal levels of malondialdehyde (MDA) and nitrite plus nitrate (NOx).</p> <p>Methods</p> <p>Male mongrel dogs (n = 27) were randomly allocated in one of the three groups: sham (no clamping, n = 9), ischemia (supraceliac aortic cross-clamping for 60 minutes, n = 9), and I/R (60 minutes of ischemia followed by reperfusion for 30 minutes, n = 9). Relaxation of visceral arteries (celiac trunk, renal and superior mesenteric arteries) was studied in organ chambers. MDA and NOx concentrations were determined using a commercially available kit and an ozone-based chemiluminescence assay, respectively.</p> <p>Results</p> <p>Both acetylcholine and calcium ionophore caused relaxation in endothelium-intact rings and no statistical differences were observed among the three groups. Sodium nitroprusside promoted relaxation in endothelium-denuded rings, and there were no inter-group statistical differences. Both plasma and renal concentrations of MDA and NOx showed no significant difference among the groups.</p> <p>Conclusion</p> <p>Supraceliac aortic cross-clamping for 60 minutes alone and followed by 30 minutes of reperfusion did not impair relaxation of canine visceral arteries nor evoke biochemical alterations in plasma or renal tissue.</p

Private trade and monopoly structures : the East India Companies and the commodity trade to Europe in the eighteenth century

Our research is about the trade in material goods from Asia to Europe over this period, and its impact on Europe’s consumer and industrial cultures. It entails a comparative study of Europe’s East India Companies and the private trade from Asia over the period. The commodities trade was heavily dependent on private trade. The historiography to date has left a blind spot in this area, concentrating instead on corruption and malfeasance. Taking a global history approach we investigate the trade in specific consumer goods in many qualities and varieties that linked merchant communities and stimulated information flows. We set out how private trade functioned alongside and in connection with the various European East India companies; we investigate how this changed over time, how it drew on the Company infrastructure, and how it took the risks and developed new and niche markets for specific Asian commodities that the Companies could not sustain

Valve replacement in patients with critical aortic stenosis and depressed left ventricular function: predictors of operative risk, left ventricular function recovery, and long term outcome

Objectives: To identify predictors of operative and postoperative mortality and of functional reversibility after aortic valve replacement (AVR) in patients with aortic stenosis (AS) and severe left ventricular (LV) systolic dysfunction. Methods and results: Between 1990 and 2000, 155 consecutive patients (mean (SD) age 72 (9) years) in New York Heart Association (NYHA) heart failure functional class III or IV (n  =  138) and with LV ejection fraction (LVEF) ⩽ 30% underwent AVR for critical AS (mean (SD) valve area index 0.35 (0.09) cm(2)/m(2)). Thirty day mortality was 12%. NYHA class (3.7 (0.6) v 3.2 (0.7), p  =  0.004), cardiothoracic ratio (CTR) (0.63 (0.07) v 0.56 (0.06), p < 0.0001), pulmonary artery systolic pressure (63 (25) v 50 (19) mm Hg, p  =  0.03), and prevalence of complete left bundle branch block (22% v 8%, p  =  0.03) and of renal insufficiency (p  =  0.001) were significantly higher in 18 non-survivors than in 137 survivors. In multivariate analysis, the only independent predictor of operative mortality was a CTR ⩾ 0.6 (odds ratio (OR) 12.2, 95% confidence interval (CI) 5.4 to 27.4, p  =  0.002). The difference between preoperative and immediate postoperative LVEF (early-ΔEF) was > 10 ejection fraction units (EFU) in 55 survivors. In multivariate analysis, CTR (OR 5.95, 95% CI 3.0 to 11.6, p  =  0.006) and mean transaortic gradient (OR 1.05, 95% CI 1.0 to 1.1, p < 0.05) were independent predictors of an early-ΔEF > 10 EFU. During a mean (SD) follow up of 4.6 (3) years, 50 of 137 (36%) 30 day survivors died, 31 of non-cardiac causes. Diabetes (OR 3.8, 95% CI 2.4 to 6.0, p  =  0.003), age ⩾ 75 years (OR 2.6, 95% CI 2.1 to 4.5, p  =  0.004), and early-ΔEF ⩽ 10 EFU (OR 0.96, 95% CI 0.94 to 0.97, p  =  0.01) were independent predictors of long term mortality. Among 127 survivors, the percentage of patients in NYHA functional class III or IV decreased from 89% preoperatively to 3% at one year. The decrease in functional class was significantly greater in patients with an early-ΔEF > 10 EFU than patients with an early-ΔEF ⩽ 10 EFU (p  =  0.02). In addition, the mean (SD) LVEF at one year was 53 (11)% in patients with an early-ΔEF > 10 EFU and 42 (11)% in patients with early-ΔEF ⩽ 10 EFU (p < 0.001). Conclusions: Despite a relatively high operative mortality, AVR for AS and severely depressed LVEF was beneficial in the majority of patients. Early postoperative recovery of LV function was associated with significantly greater relief of symptoms and longer survival