Tomo Ando

A review of comparative studies of MitraClip versus surgical repair for mitral regurgitation.

OBJECTIVESnWe summarized comparative studies of MitraClip versus surgical repair for mitral regurgitation (MR) with a systematic literature search and meta-analytic estimates.nnnMETHODSnMEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched through June 2016. Eligible studies were randomized controlled or observational comparative studies of MitraClip versus surgical repair enrolling patients with MR and reporting early (30-day or in-hospital) or late (≥6-month including early) all-cause mortality. For each study, data regarding all-cause mortality and incidence of recurrent >2+ MR in both groups were used to generate odds ratios (ORs). Alternatively, ORs or hazard ratios (HRs) for mortality and recurrent MR themselves were directly abstracted from each study.nnnRESULTSnEight reports of 7 studies comparing MitraClip with surgical repair enrolling a total of 1015 patients with MR were identified and included. Pooled analyses demonstrated significantly higher age and logistic European System of Cardiac Operative Risk Evaluation and significantly lower ejection fraction in the MitraClip than surgical repair group, no significant difference in rate of women and patients with New York Heart Association functional class of >II, no statistically significant difference in early- (OR, 0.54; p=0.08) and late-mortality (HR/OR, 1.17; p=0.46), and significantly higher incidence of recurrent MR in the MitraClip than surgical repair group (HR/OR, 4.80; p<0.00001).nnnCONCLUSIONSnIn patients with MR, the MitraClip procedure achieves similar survival to surgical MV repair despite higher risk profiles. Recurrent MR, however, occurs more frequently (4.8-fold) after the MitraClip than surgical repair.

Abdominal Aortic Aneurysm Screening Reduces All-Cause Mortality: Make Screening Great Again:

We performed an updated meta-analysis of the longest (≥13 years) follow-up results from 4 randomized controlled trials of abdominal aortic aneurysm (AAA) screening in ≥64-year-old men. Invitation to screening reduced all-cause mortality significantly according to time-to-event data (hazard ratio: 0.98; 95% confidence interval [CI]: 0.96-0.99; P = .003) despite no reduction according to dichotomous data (odds ratio [OR]: 0.99; 95% CI: 0.96-1.01; P = .23). Invitation to screening reduced AAA-related mortality significantly (OR: 0.66; 95% CI: 0.47-0.93; P = .02) but did not reduce non-AAA-related mortality (OR: 1.00; 95% CI: 0.98-1.02; P = .96). All-cause, AAA-related, and non-AAA-related mortalities were significantly lower in attenders than in nonattenders, in noninvitees, or in both. All-cause (OR: 1.41; 95% CI: 1.23-1.63; P < .00001) and non-AAA-related mortalities (OR: 1.39; 95% CI: 1.18-1.64; P < .0001) were significantly higher in nonattenders than in noninvitees. In conclusion, invitation to AAA screening in ≥64-year-old men reduced both all-cause and AAA-related mortalities significantly. All-cause and non-AAA-related mortalities were significantly higher in nonattenders than in noninvitees, though both did not undergo screening.

Worse late-phase survival after elective endovascular than open surgical repair for intact abdominal aortic aneurysm

OBJECTIVESnTo determine whether follow-up survival is better after elective endovascular aneurysm repair (EVAR) than open surgical repair (OSR) for intact abdominal aortic aneurysm (AAA), we combined 5-year survival curves themselves of EVAR and OSR in randomized controlled trials (RCTs) and propensity-score matched (PSM) studies.nnnMETHODSnEligible studies were RCTs or PSM studies of elective EVAR versus OSR enrolling patients with intact AAA and reporting 5-year (at least) survival curves. Data regarding detailed inclusion criteria, duration of follow-up, and survival curves were abstracted from each individual study. In case of crossing of the combined survival curves, a pooled late-phase (between the crossing time and 5years) hazard ratio (HR) for all-cause mortality was calculated.nnnRESULTSnOur search identified 7 eligible studies (including 2 RCTs and 5 PSM studies) enrolling a total of 92,333 patients with AAA assigned to EVAR or OSR. Pooled survival rates after EVAR and OSR were 98.1% and 96.1 at 1month, 94.2% and 93.1% at 1year, 85.1% and 86.8% at 3years, and 75.8% and 78.8% at 5years, respectively. The survival curves crossed at 1.8years with the survival rate of 90.5%. A pooled late-phase (between 1.8years and 5years) HR for calculated from data of the combined survival curves significantly favored OSR (1.29, 95% confidence interval, 1.24 to 1.35; p<0.00001).nnnCONCLUSIONSnFor intact AAA, although survival was better immediately after elective EVAR than OSR, the survival curves crossed at 1.8years. Thereafter until 5years, survival was worse after EVAR than OSR.

Trends in Vascular Complications in High-Risk Patients Following Transcatheter Aortic Valve Replacement in the United States

Vascular complications (VC) following transcatheter aortic valve replacement (TAVR) are associated with worse outcomes. The trend of VC incidence in patients considered high risk is unclear. We sought to assess the trend of VC after TAVR in patients at high risk. We investigated the VC trend in female, diabetes mellitus, and peripheral vascular disease (PVD) patients. Patients who underwent TAVR from 2011 to 2014 in the United States were identified using the International Classification of Diseases-Ninth Revision code 35.05 from the Nationwide Inpatient Sample database. Frequency of any VC (per 100 transcatheter aortic valve implantation procedure or hospital discharges) for each year from 2011 to 2014 was assessed for the overall population as well as within each category of high-risk cohorts. The overall VC rate was 6.0% (2,044/33,790). Patients who had VC were more likely to be female and had higher rates of PVD at baseline. The annual rate of VC in the overall population from 2011 to 2014 was 4.6%, 9.4%, 6.8%, and 4.4%, respectively. There was a significant increase in VC rate from 2011 to 2012 (pxa0= 0.03), whereas there was a significant decrease in VC rate from 2012 to 2014 (p <0.001). The rate of VC between 2011 and 2014 was similar (pxa0= 0.82). The rate of VC did not increase in any of the high-risk groups from 2011 to 2012. However, the rate of VC from 2012 to 2014 decreased significantly in all the high-risk groups. The VC rate was similar for groups between 2011 and 2014. The overall VC rate among TAVR patients initially increased from 2011 to 2012 but decreased thereafter. Similar trend in VC rate was found among high-risk patients except that the initial increase in rates from 2011 to 2012 did not reach statistical significance. Whether further reduction in VC with improvement in devices and operator/center experience for both overall and high-risk groups in TAVR occurs will require continuous longitudinal monitoring.

Does diabetes mellitus impact prognosis after transcatheter aortic valve implantation? Insights from a meta-analysis.

BACKGROUNDnDiabetes mellitus (DM) is well known to increase mortality in several cardiovascular diseases. However, the prognostic impact of DM following transcatheter aortic valve implantation (TAVI) remains controversial. We sought to assess the impact of DM on perioperative (in-hospital or 30-day) complications and mid-term (≥1 year) all-cause mortality after TAVI through meta-analysis.nnnMETHODSnA comprehensive literature search of PUBMED and EMBASE was conducted through January 1st 2002 to May 15th 2016. Articles that reported adjusted hazards ratio (HRs) or unadjusted HR for mid-term all-cause mortality with 95% confidence intervals (CIs) of DM or insulin dependent DM (IDDM) on mid-term all-cause mortality post TAVI were included in the analysis. A meta-analysis was performed with combination of both adjusted HR and un-adjusted HR. Sensitivity analysis was performed with only the adjusted HR. Random-effects model was used to calculate the pooled effect size.nnnRESULTSnA total of 22 observational cohort studies were identified with 28,440 (8998 DM and 19,442 non-DM) patients. The risk of perioperative complications (myocardial infarction, bleeding, major vascular complications, stroke, and new-onset atrial fibrillation) was similar between DM and non-DM cohorts. A meta-analysis of all-cause mortality of DM (19 studies after excluding 3 studies that only reported HR of IDDM on mid-term all-cause mortality, 8808 DM and 17,829 non-DM patients) resulted in significantly worse outcome (HR 1.21, 95%CI 1.10-1.34, p=0.0002, I2=53%) in DM patients compared to non-DM patients post-TAVI. Sensitivity analysis showed consistent results. Subgroup analysis (4 studies with 267 IDDM versus 2161 non-IDDM) demonstrated that IDDM was associated with higher all-cause mortality (HR 2.05, 95%CI 1.54-2.73, p<0.00001, I2=0%) following TAVI.nnnCONCLUSIONSnDM was associated with similar perioperative complications but was associated with increased mid-term all-cause mortality after TAVI. Further study of the causes of increased mortality during the follow-up may lead to improved outcome.

Comparison of outcomes in new-generation versus early-generation heart valve in transcatheter aortic valve implantation: A systematic review and meta-analysis.

BACKGROUNDnNew-generation (NG) valves for transcatheter aortic valve implantation (TAVI) has recently been widely used in real-world practice, yet its comparative outcomes with early-generation (EG) valves remain under-explored.nnnMETHODSnAn electronic literature search using PUBMED and EMBASE was conducted from inception to April 2017 for matched-cohort studies. Articles that compared the outcomes of NG vs. EG valves post TAVI with at least one of the following clinical outcome reported were included: all-cause mortality, major or life-threatening bleeding, major vascular complications (MVC), significant (more than moderate) paravalvular regurgitation (PVR), cerebrovascular events, significant (stage 2 or 3) acute kidney injury (AKI) and new permanent pacemaker implantation (PPI) that occurred either in-hospital or within 30-days.nnnRESULTSnA total of 6 observational matched-cohort studies with 585 and 647 patients included in NG and EG valves, respectively, were included. EG valves were associated with a lower incidence of major or life-threatening bleeding (5.7% vs. 15.7%, p<0.00001), significant paravalvular regurgitation (5.3% vs. 14.4%, p=0.001), and significant AKI (4.4% vs. 7.5, p=0.03). All-cause mortality (3.5% vs. 5.0, p=0.43), cerebrovascular events (3.4% vs. 2.3%, p=0.34) and new PPI (11.0% vs. 14.6%, p=0.52) were similar between the two groups. NG demonstrated lower tendency of MVC (2.5% vs. 7.2, p=0.09) compared to EG valves.nnnCONCLUSIONSnNG demonstrated lower rates of significant AKI, significant PVR and major or life-threatening bleeding while all-cause mortality, new PPI, and cerebrovascular events remained similar compared to EG valves.

Meta-Analysis of Seasonal Incidence of Aortic Dissection

We performed the first meta-analysis to identify in which season incidence of aortic dissection is the most and least frequent. MEDLINE and EMBASE were searched through February 2017. Eligible studies were observational studies enrolling patients with aortic dissection and reporting seasonal or monthly incidence of aortic dissection. Study-specific estimates, incidence of aortic dissection in each season (number of aortic dissection in a season divided by that in a year) and risk ratios (RRs) for incidence of aortic dissection in a season versus another season, were combined using the random-effects model. We identified 18 eligible studies enrolling a total of 101,264 patients with aortic dissection. Pooled incidence was 20.6% in summer, 24.8% in autumn, 28.2% in winter, and 25.5% in spring. Pooled analysis demonstrated a statistically significant increase in incidence of aortic dissection in autumn than in summer (RR 1.18; p <0.0001), in winter than in summer (RR 1.37; p <0.0001), in spring than in summer (RR 1.24; p <0.0001), in winter than in spring (RR 1.11; pxa0= 0.006), and in winter than in autumn (RR 1.17; p <0.001); and no statistically significant difference between spring and autumn (RR 1.04; pxa0= 1.00). In conclusion, the incidence in winter (28.2%) was significantly more frequent than that in other seasons and that in summer (20.6%) was significantly less frequent than that in other seasons (winter > spring ≈ autumn > summer).

Comparison of Hospital Outcome of Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Diabetes Mellitus (from the Nationwide Inpatient Sample)

The comparative outcomes of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in diabetes mellitus (DM) patients are scarce. We aimed to assess and compare the outcomes of TAVR versus SAVR in DM patients using the Nationwide Inpatient Sample database from 2011 to 2013. A complete case analysis was performed for the multivariate analysis and cases with missing data were excluded. The primary end point was in-patient all-cause mortality and secondary outcomes were perioperative complications. An estimated 5,719 TAVR procedures and 65,096 SAVR procedures were performed among DM patients in the United States between 2011 and 2013. TAVR patients were older (80 ± 8.1 vs 70 ± 10, p <0.001), majority of them were women (45% vs 38%, p <0.001), and predominantly white race (total of 80%). The adjusted odds ratio (OR) for the primary outcome was significantly lower in TAVR patients (2.8% vs 3.6%, OR 0.63, pxa0= 0.02). TAVR patients were also at lower risk for bleeding requiring transfusions (13% vs 20%, OR 0.43, p <0.01), cardiac complications (6.1% vs 14%, OR 0.34, p <0.01), respiratory complications (1.2% vs 3.7%, OR 0.26, p <0.01), postoperative sepsis (1.7% vs 3.6%, OR 0.45, pxa0= 0.03), and acute myocardial infarction (2.5% vs 2.9%, OR 0.62, p <0.01), compared with SAVR patients. Conversely, TAVR patients were at increased risk for vascular complications (5.7% vs 3.9%, OR 1.5, p <0.01) and new pacemaker implantation (10% vs 5.7%, OR 1.5, p <0.01). The mean hospitalization cost was lower for TAVR than SAVR (

Meta-Analysis Comparing ≥10-Year Mortality of Off-Pump Versus On-Pump Coronary Artery Bypass Grafting

58,878 vs

Long-term survival after transcatheter versus surgical aortic valve replacement for aortic stenosis: A meta-analysis of observational comparative studies with a propensity-score analysis

63,869, pxa0= 0.003). Length of stay (median 6 vs 8xa0days, p <0.001) was shorter in TAVR patients. In conclusion, TAVR may result in better in-hospital outcome than SAVR in DM patients.