No protection of heart, kidneys and brain by remote ischemic preconditioning before transfemoral transcatheter aortic valve implantation: Interim-analysis of a randomized single-blinded, placebo-controlled, single-center trial.

Remote ischemic preconditioning (RIPC) reduces myocardial injury and improves clinical outcome in patients undergoing coronary revascularization, but only in the absence of propofol-anesthesia. We investigated whether RIPC provides protection of heart, kidneys and brain and improves outcome in patients undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI). Patients undergoing TF-TAVI were randomized to receive RIPC (3cycles of 5min left upper arm ischemia and 5min reperfusion) or placebo. The primary endpoint was myocardial injury, reflected by the area under the curve for serum troponin I concentrations (AUC-TnI) over the first 72h. Secondary endpoints included the incidences of periprocedural myocardial infarction, delayed gadolinium enhancement on postprocedural cardiac MRI, acute kidney injury, periprocedural stroke, and the incidence and volume of new lesions on postprocedural cerebral MRI. All-cause and cardiovascular mortality and major adverse cardiac and cerebrovascular events (MACCE) were assessed over 1-year follow-up. A prespecified interim-analysis was performed after the last patient had completed 1-year follow-up (NCT02080299). 100 consecutive patients were enrolled between September 2013 and June 2015. There were no significant between-group differences in the primary endpoint of peri-interventional myocardial injury (ratio RIPC/placebo AUC-TnI: 0.87, 95% CI: 0.57-1.34, p=0.53) or the secondary endpoints of cardiac, renal and cerebral impairment. There was no significant treatment effect in subgroup-analyses of patients undergoing cardiac or cerebral MRI. Mortality and MACCE did not differ. No RIPC-related adverse events were observed. RIPC did neither protect heart, kidneys and brain nor improve clinical outcome in patients undergoing TF-TAVI.

Kahlert P ，Hildebrandt HA ，Patsalis PC ，Al-Rashid F ，Jánosi RA ，Nensa F ，Schlosser TW ，Schlamann M ，Wendt D ，Thielmann M ，Kottenberg E ，Frey U ，Neuhäuser M ，Forsting M ，Jakob HG ，Rassaf T ，Peters J ，Heusch G ，Kleinbongard P ... -  《-》

The effect of Remote Ischemic Preconditioning (RIPC) on myocardial injury and inflammation in patients with severe aortic valve stenosis undergoing Transcatheter Aortic Valve Replacement (TAVΙ).

Remote ischemic preconditioning (RIPC) is being evaluated as a strategy to reduce cardiac injury and inflammation in patients undergoing diverse cardiac invasive and surgical procedures. However, it is unclear whether RIPC has protective effects in patients undergoing the transfemoral- transcatheter aortic valve implantation (TF-TAVΙ) procedure. Between September 2013 and September 2015, 55 random consecutive patients were prospectively assigned to receive SHAM preconditioning (SHAM, 22 patients) or Remote Ischemic Preconditioning (RIPC) (4 cycles of 5 min intermittent leg ischemia and 5 min reperfusion, 33 patients) prior to TF-TAVI. The primary endpoint was to determine the serum levels of: hs-cTn-I (necrosis), CK-18 (apoptosis), and IL-1b (inflammation). Quantification was performed using commercially available ELISA kits. Patients were sampled 1-day pre TF-TAVΙ and 24-hours post TF-TAVΙ. Secondary endpoints included: total mortality, incidence of periprocedural clinical acute myocardial infarction (AMI), acute kidney injury (AKI), and stroke. 22 SHAM patients and 33 RIPC patients were finally analyzed. Our data revealed no significant difference in serum levels of hs-cTn-I and CK-18 among various groups. However, in the RIPC group, the increase in IL1b level was significantly lower for 24-h post TF-TAVΙ, (p < 0.01). There were no significant differences between groups in the secondary endpoints at the follow-up interval of one month. RIPC-related adverse events were not observed. Our data suggest that RIPC did not exhibit significant cardiac or kidney protective effects regarding necrosis and apoptosis in patients undergoing TF-TAVΙ. However, an important anti-inflammatory effect was detected in the RIPC group.

Halapas A ，Kapelouzou A ，Chrissoheris M ，Pattakos G ，Cokkinos DV ，Spargias K ... -  《-》

Remote ischemic preconditioning in aortic valve surgery: Results of a randomized controlled study.

Although remote ischemic preconditioning (RIPC) has emerged as an attractive strategy to reduce cardiac injury in patients undergoing diverse cardiac surgical procedures, it is unclear whether RIPC has protective effects in patients undergoing aortic valve replacement surgery without coronary artery bypass grafting (CABG). Hence, 100 adult patients undergoing elective aortic valve replacement for aortic valve stenosis, without combined surgery with CABG, were prospectively randomly assigned in a 1:1 ratio to either the RIPC group or the control group. The RIPC group underwent three cycles of 5-min inflation to 200mmHg and 5-min deflation of an automated upper-arm cuff inflator after induction of anesthesia. The control group had a deflated cuff placed on upper arm for 30min. The primary endpoint was 72-h area under curve (AUC) for troponin I (cTnI). Secondary endpoints were 72-h AUC for creatine kinase-MB isoenzyme (CK-MB) release, incidence of acute kidney injury, extubation time, length of stay in intensive care unit, and simplified acute physiology score (SAPS II). There were no significant differences in cTnI AUC [195±190 arbitrary units (a.u.) in RIPC group vs. 169±117 a.u. in the control group; p=0.41] and CK-MB AUC between groups. None of the other secondary endpoints differed between groups. Acute kidney injury occurred in 12 patients (24.5%) in the control group and in 13 (26.0%) in the RIPC group (p=0.86). RIPC did not exhibit significant cardiac or kidney protective effects in patients undergoing aortic valve replacement surgery without CABG.

Pinaud F ，Corbeau JJ ，Baufreton C ，Binuani JP ，De Brux JL ，Fouquet O ，Angoulvant D ，Furber A ，Prunier F ... -  《-》

A meta-analysis of mortality and major adverse cardiovascular and cerebrovascular events in patients undergoing transfemoral versus transapical transcatheter aortic valve implantation using edwards valve for severe aortic stenosis.

The purpose of this meta-analysis was to compare 1 year mortality and major adverse cardiovascular and cerebrovascular events between transfemoral (TF) transcatheter aortic valve implantation (TAVI) and transapical (TA) TAVI performed using Edwards valves. PubMed, Embase, and the Cochrane Center Register of Controlled Trials were searched for studies published from January 2000 through March 2014. Seventeen studies met the inclusion criteria and were included in the analysis. This meta-analysis included total of 2,978 patients with severe aortic stenosis not eligible for traditional surgical procedures who underwent TF TAVI (n = 1,465) or TA TAVI (n = 1,513). End points were in-hospital, 30-day, and 1-year all-cause mortality, stroke, myocardial infarction, major bleeding, and major vascular complications. Odds ratios (ORs) with 95% confidence interval (CIs) were computed, and p values <0.05 were considered to indicate statistical significance. The studies were homogenous for all outcomes except 1-year mortality. There was no significant difference between the TF and TA TAVI groups for 1-year mortality (OR 0.64, 95% CI 0.34 to 1.2, p = 0.16), incidence of stroke (OR 1.14, 95% CI 0.76 to 1.71, p = 0.52), incidence of myocardial infarction (OR 0.62, 95% CI 0.23 to 1.7, p = 0.35), and incidence of bleeding events (OR 0.76, 95% CI 0.51 to 1.14, p = 0.19). Thirty-day all-cause mortality was significantly less with TF TAVI compared with TA TAVI (OR 0.59, 95% CI 0.45 to 0.76, p <0.0001). Major vascular events were significantly higher in the TF TAVI group compared with the TA TAVI group (OR 4.33, 95% CI 3.14 to 5.97, p <0.00001). In conclusion, the results of this meta-analysis of 2,978 patients revealed that TA TAVI had similar 1-year major adverse cardiovascular and cerebrovascular events, fewer major vascular complications, but higher 30-day mortality compared with TF TAVI. In patients with contraindications to TF TAVI, TA TAVI is a reasonable option, although further randomized trials are warranted for evaluating long-term clinical outcomes between TF and TA TAVI.

Panchal HB ，Ladia V ，Amin P ，Patel P ，Veeranki SP ，Albalbissi K ，Paul T ... -  《-》

Effect of a Cerebral Protection Device on Brain Lesions Following Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis: The CLEAN-TAVI Randomized Clinical Trial.

Haussig S ，Mangner N ，Dwyer MG ，Lehmkuhl L ，Lücke C ，Woitek F ，Holzhey DM ，Mohr FW ，Gutberlet M ，Zivadinov R ，Schuler G ，Linke A ... -  《-》