Paola Tellaroli

Early and Midterm Outcome of Propensity-Matched Intermediate-Risk Patients Aged ≥80 Years With Aortic Stenosis Undergoing Surgical or Transcatheter Aortic Valve Replacement (from the Italian Multicenter OBSERVANT Study)

The aim of this study was to analyze procedural and postprocedural outcomes of patients aged ≥80 years treated by transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) as enrolled in the OBservational Study of Effectiveness of SAVR-TAVR procedures for severe Aortic steNosis Treatment (OBSERVANT) Study. TAVI is offered to patients with aortic stenosis judged inoperable or at high surgical risk. Nevertheless, it is common clinical practice to treat elderly (≥80 years) patients by TAVI regardless of surgical risk for traditional SAVR. OBSERVANT is a multicenter, observational, prospective cohort study that enrolled patients with symptomatic severe aortic stenosis who underwent SAVR or TAVI from December 2010 to June 2012 in 93 Italian participating hospitals. Information on demographic characteristics, health status before intervention, therapeutic approach, and intraprocedural and 30-day outcomes was collected. An administrative follow-up was set up to collect data on midterm to long-term outcomes. We reviewed baseline and procedural data of patients aged ≥80 years, looking for different early and late outcome after TAVI or SAVR. Patients treated by TAVI were sicker than SAVR because of higher rate of co-morbidities, advanced illness, frailty, and Logistic EuroSCORE. After propensity matching, early and midterm mortality were comparable between the 2 groups. However, patients treated by TAVI had higher rate of vascular complications (6.0% vs 0.5%; p <0.0001), permanent pacemaker implantation (13.4% vs 3.7%; p <0.0001), and paravalvular leak (8.9% vs 2.4%; p <0.0001). Patients who underwent SAVR had more frequent bleedings needing transfusion (63.2% vs 34.5%; p <0.0001) and acute kidney injury (9.6% vs 3.9%; p = 0.0010). In conclusion, patients aged ≥80 years treated by TAVI or SAVR had similar early and midterm mortality.

Perioperative noninvasive ventilation in obese patients: a qualitative review and meta-analysis

BACKGROUND Perioperative noninvasive ventilation (NIV) has been proposed to reduce postoperative morbidity and improve perioperative outcomes in patients undergoing general anesthesia. Whether it is advantageous to apply NIV just before and after general anesthesia in obese patients has not been yet established. OBJECTIVES To perform a qualitative review and meta-analysis to assess the effectiveness and tolerability of perioperative NIV in obese patients. METHODS All studies in English language performed in clinical setting that compared the application of NIV with standard care just before and after induction of general anesthesia in obese adults (body mass index [BMI]≥35 kg/m(2)) were included. Data on oxygenation, respiratory function, complications, and outcomes were extracted. RESULTS Twenty-nine articles were selected and used in the qualitative review. Eleven studies including 768 patients were used for subsequent meta-analyses. Compared with standard preoxygenation, NIV was associated with a significant improvement in oxygenation (P<.0001) before tracheal intubation. Benefits in oxygenation (P<.0001), clearance of carbon dioxide (P<.0001), and pulmonary function testing (P<.0001) after general anesthesia were observed with NIV compared with standard care. Postoperatively, NIV was associated with a decreased risk of respiratory complications (relative risk [RR] = .33; 95% confidence interval [CI] .16-.66; P = .002), but not of reintubation after tracheal extubation (RR = .41; 95% CI .09-1.82]; P = .3657) and unplanned intensive care unit admission (RR = .43; 95% CI .16-1.15; P = .0937). NIV-related complications in obese patients were mainly due to intolerance and ranged from 7% to 28% of cases. NIV-related anastomotic leakage and adverse events were not reported. CONCLUSIONS Results from this review and meta-analysis suggest that NIV is well tolerated and effective in improving perioperative care in obese patients. The application of NIV before and after general anesthesia should be considered and promoted in relevant cases.

Optimal duration of dual antiplatelet therapy after second-generation drug-eluting stent implantation in patients with diabetes: The SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed By Six- Versus Twelve-Month Dual Antiplatelet Therapy)-diabetes substudy

BACKGROUND/OBJECTIVES The randomized SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy) trial showed the non-inferiority of 6 vs. 12-month DAPT after percutaneous coronary intervention (PCI) with second-generation DES in a low-risk population. Nevertheless, diabetes mellitus (DM) remained a major predictor of adverse cardiovascular events. We aimed to assess the interaction between DAPT duration and outcome in DM patients. METHODS All diabetic patients included in the SECURITY trial treated by second-generation DES PCI were analyzed. The primary endpoint was a composite of cardiac death, myocardial infarction (MI), stroke, definite or probable stent thrombosis (ST), or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 12months. The main secondary endpoint was a composite of cardiac death, MI, stroke, definite or probable ST, or BARC type 2, 3, or 5 bleeding at 24months. RESULTS Four hundred-twenty nine DM patients received either 6 (n=206) or 12 (n=223) months of DAPT. The primary endpoint occurred in 3.9% and 5.4% of patients in the 6 and 12-month DAPT group, respectively (log-rank test p=0.83). Similarly, no statistically significant difference in the secondary endpoint was observed between the two study groups (5.4% vs. 7.6%, p=0.620). Stent thrombosis rate was low irrespective of DAPT duration at both 12 (0.5% vs. 0.4%; p=0.804) and between 12 and 24months of follow-up (0.5% vs. 0%, p=0.291). At multivariable analysis, female gender (HR: 3.42; 95% CI 1.32-8.85; p=0.011 and HR 2.28; 95% CI 1.09-4.75; p=0.027) and insulin-treated diabetes mellitus (HR: 2.62; 95% CI 1.15-6.75; p=0.004 and HR: 2.23; 95% CI 1.09-6.33; p=0.003) were independent predictors of both primary and secondary endpoint. CONCLUSIONS In diabetic patients treated by second-generation DES PCI, we failed to find any additional benefit of prolonging DAPT beyond 6months, regardless of insulin-requiring status.

Cross-Clustering: A Partial Clustering Algorithm with Automatic Estimation of the Number of Clusters.

Four of the most common limitations of the many available clustering methods are: i) the lack of a proper strategy to deal with outliers; ii) the need for a good a priori estimate of the number of clusters to obtain reasonable results; iii) the lack of a method able to detect when partitioning of a specific data set is not appropriate; and iv) the dependence of the result on the initialization. Here we propose Cross-clustering (CC), a partial clustering algorithm that overcomes these four limitations by combining the principles of two well established hierarchical clustering algorithms: Ward’s minimum variance and Complete-linkage. We validated CC by comparing it with a number of existing clustering methods, including Ward’s and Complete-linkage. We show on both simulated and real datasets, that CC performs better than the other methods in terms of: the identification of the correct number of clusters, the identification of outliers, and the determination of real cluster memberships. We used CC to cluster samples in order to identify disease subtypes, and on gene profiles, in order to determine groups of genes with the same behavior. Results obtained on a non-biological dataset show that the method is general enough to be successfully used in such diverse applications. The algorithm has been implemented in the statistical language R and is freely available from the CRAN contributed packages repository.

Clinical outcomes of overlapping versus non-overlapping everolimus-eluting absorb bioresorbable vascular scaffolds: An analysis from the multicentre prospective RAI registry (ClinicalTrials.gov identifier: NCT02298413)

To compare clinical outcomes of patients treated with overlapping versus non‐overlapping Absorb BVS. Background: Limited data are available on the clinical impact of stent overlap with the Absorb BVS bioresorbable stent. Methods: We compared outcomes of patients receiving overlapping or non‐overlapping Absorb BVS in the multicenter prospective RAI Registry. Results: Out of 1,505 consecutive patients treated with Absorb BVS, 1,384 were eligible for this analysis. Of these, 377 (27%) were in the overlap group, and 1,007 (73%) in the non‐overlap group. The most frequent overlap configuration was the marker‐to‐marker type (48%), followed by marker‐over‐marker (46%) and marker‐inside‐marker (6%) types. Patients of the overlap group had higher prevalence of multivessel disease and higher SYNTAX score, and required more frequently the use of intravascular imaging. At a median follow‐up of 368 days, no difference was observed between overlap and non‐overlap groups in terms of a device‐related composite endpoint (cardiac death, TV‐MI, ID‐TLR) (5.8% vs. 4.1%, P = 0.20) or of a patient‐related composite endpoint (any death, any MI, any revascularization) (15.4% vs. 12.5%, P = 0.18). Cardiac death (1.0% vs. 1.3%, P = 0.54), MI (4.5% vs. 3.6%, P = 0.51), TVR (4.5% vs. 3.6%, P = 0.51) and stent thrombosis (1.1 vs. 1.5%, P = 1.00) were also comparable between groups. When assessing outcomes of the overlap population according to overlap configurations used, no difference was observed in terms of the device‐ or patient‐related composite endpoints. Conclusions: Outcomes of patients with or without overlapping BVS were comparable at mid‐term follow‐up despite higher angiographic complexity of the overlap subset.

Isolated forearm technique: a meta-analysis of connected consciousness during different general anaesthesia regimens

Background General anaesthesia should prevent patients from experiencing surgery, defined as connected consciousness. The isolated forearm technique (IFT) is the current gold standard for connected consciousness monitoring. We evaluated the efficacy of different anaesthesia regimens in preventing IFT responses. Methods We conducted a systematic review with meta‐analysis of studies evaluating IFT in adults. Proportions of IFT‐positive patients were compared for inhalational versus intravenous anaesthesia and anaesthesia brain monitor (ABM)‐guided versus non‐ABM‐guided. Results Of 1131 patients in 22 studies, 393 (34.8%) had an IFT response during induction or maintenance. IFT‐positive patients were less frequent during induction (19.7% [95% CI, 17.5–22.1]) than during maintenance (31.2% [95% CI, 27.8–34.8]). Proportions of IFT‐positive patients during induction and maintenance were similar for inhalational (0.51 [95% CI, 0.38–0.65]) and intravenous (0.52 [95% CI, 0.26–0.77]) anaesthesia, but during maintenance were lower with inhalational (0.18 [95% CI, 0.08–0.38]) than with intravenous (0.48 [95% CI, 0.24–0.73]) anaesthesia. Proportions of IFT‐positive patients during induction and maintenance were not significantly different for ABM‐guided (0.64 [95% CI, 0.39–0.83]) and non‐ABM‐guided (0.48 [95% CI, 0.34–0.62]) anaesthesia but during maintenance were lower with non‐ABM‐guided (0.19 [95% CI, 0.09–0.37]) than with ABM‐guided (0.57 [95% CI, 0.34–0.77]). Proportions of IFT‐positive patients decreased significantly with increasing age and premedication use. Of the 34 anaesthesia regimens, 16 were inadequate. Studies had low methodological quality (only seven randomised controlled trials) and significant heterogeneity. Conclusions Standard general anaesthesia regimens might not prevent connected consciousness. More accurate anaesthesia brain monitor methodology to reduce the likelihood of connected consciousness is desirable.

TCT-425 Bioresorbable vascular scaffold technology for small vessel coronary artery disease: results from the Italian multicenter RAI Registry

RESULTS A total of 207 patients with at least one SV were included in this analysis. Mean follow-up time was 22.4 months 14.9 with 85.8 % of patients having at least 1 year of follow-up. Clinical presentation of pts. (72.4% male, mean age 58.5 11.7 years, 16.4% diabetics, 25.6% with previous PCI and/or CABG) was ACS in 55.1%. Multivessel treatment was perfomed in 17,9% (37 pz). Mean lesion length by QCA was 23.7 11.0 mm and mean RVD was 2.2 0.3 mm with 14.5% of moderate/sever calcification lesions and 19.8 % of bifurcation treatment. Pre-dilatation was performed in 93.2% and post-dilatation in 57.9%. The mean scaffold length was 28.1 15.0 mm with 30.9% of cases using overlapping scaffolds. OCT or IVUS was used in 26.0%. Device success was 99.0% (failure to deliver in 2 pts). Over the entire follow-up period, death occurred in 3.4 % (7/207), myocardial infarction (MI) in 5.3% (11/207), target lesion revascularization in 7.2 % (15/207), target vessel revascularization (TVR) in 8.2% (17/207), non-target vessel revascularization in 2.9 (6/207) %. Overall MACE (death, MI, TVR) rate was 12.0% (25/207). Definite stent thrombosis (ST) occurred in 6 pts. (2.9%), of whom early ST occurred in 4 pts and late ST in 2 pts.

Impact of atrial fibrillation on outcomes of patients treated by transcatheter aortic valve implantation: A systematic review and meta-analysis

BACKGROUND Conflicting data have been reported related to the impact of atrial fibrillation (AF) on the outcomes after transcatheter aortic valve implantation (TAVI). We aimed to assess the prognosis of TAVI-treated patients according to the presence of pre-existing or new-onset AF. METHODS Studies published between April 2002 and November 2016 and reporting outcomes of pre-existing AF, new-onset AF, or sinus rhythm in patients undergoing TAVI were identified with an electronic search. Pairwise and network meta-analysis were performed. Outcomes of interest were short- and long-term mortality, stroke, and major bleeding. RESULTS Eleven studies (11,033 individuals) were eligible. Compared to sinus rhythm, short-term and long-term mortality were significantly higher in new-onset AF (short-term OR 2.9, P=.002; long-term OR 2.3, P<.0001) and pre-existing AF groups (short-term OR 2.7, P=.004; long-term OR 2.8, P<.0001). Compared to sinus rhythm, new-onset AF increased the risk of stroke at early (OR 2.1, P<.0001) and late follow-up (OR 1.92, P<.0001), and the risk of early bleedings (OR 1.65, P=.002), while pre-existing AF increased the risk of late stroke (OR 1.3, P=0.03), but not the risk of bleeding. Compared to pre-existing AF, new-onset AF correlated with higher risk of early stroke (OR 1.7, P=.002) and major bleedings (OR 1.7, P=.002). CONCLUSIONS AF is associated with impaired outcomes after TAVI, including mortality, stroke and (limited to new-onset AF) major bleedings. Compared to pre-existing AF, new-onset AF correlates with higher risk of early stroke and major bleedings. Improved management of AF in the TAVI setting, including tailored antithrombotic treatment strategies, remains a relevant need.

Absorb bioresorbable vascular scaffold vs. everolimus-eluting metallic stent in small vessel disease: A propensity matched analysis of COMPARE II, RAI, and MAASSTAD-ABSORB studies

Patients with small vessel disease (SVD) are at higher risk of adverse events after PCI compared to non‐SVD patients. In this subset, the use of bioresorbable vascular scaffolds (BVS) has raised particular concern.

Reply: Treatment Strategies for Patients With ST-Segment Elevation Myocardial Infarction and Multivessel Disease: Is Staged PCI Truly the Best Option?

We thank Dr. Tamis-Holland and colleagues for their interest in our article [(1)][1]. We recognize that combining prospective observational studies with randomized controlled trials (RCTs) might be a limitation, but this was done to increase the statistical power of our observations. We acknowledge