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The influence of native aortic valve calcium and transcatheter valve oversize on the need for pacemaker implantation after transcatheter aortic valve insertion. - The Journal of thoracic and cardiovascular surgery
Native aortic valve calcium and transcatheter aortic valve oversize have been reported to predict pacemaker implantation after transcatheter aortic valve insertion. We reviewed our experience to better understand the association.We retrospectively reviewed the records of 300 patients with no prior permanent pacemaker implantation who underwent transcatheter aortic valve insertion from November 2008 to February 2015. Valve oversize was calculated using area. The end point of the study was 30-day postoperative pacemaker implantation.Patient data included age of 81.1Â Â±Â 8.4Â years, female sex in 135 patients (45%), atrial fibrillation in 74 patients (24.7%), Society of Thoracic Surgeons predicted risk of mortality of 7.6% (interquartile range [IQR], 5.3-10.6), aortic valve calcium score of 2568 (IQR, 1775-3526) Agatston units, and annulus area of 471Â Â±Â 82Â mm(2). Balloon-expandable valves were inserted in 244 patients (81.3%). Transcatheter aortic valve oversize was 12.8% (IQR, 3.9-23.3). Pacemaker implantation was performed in 59 patients (19.7%). Aortic valve calcium score (adjusted PÂ =Â .275) and transcatheter valve oversize (adjusted PÂ =Â .833) were not independent risk factors for pacemaker implantation when controlling for preoperative right bundle branch block (adjusted odds ratio, 3.49; 95% confidence interval, 1.61-8.55; PÂ =Â .002), implantation of self-expanding valve (adjusted odds ratio, 4.09; 95% confidence interval, 1.53-10.96; PÂ =Â .005), left bundle branch block (adjusted PÂ =Â .331), previous percutaneous coronary intervention (adjusted PÂ =Â .053), or valve surgery (adjusted PÂ =Â .111), and PR interval (adjusted PÂ =Â .350).Right bundle branch block and implantation of a self-expanding prosthesis were predictive of pacemaker implantation, but not native aortic valve score or transcatheter valve oversize.Copyright Â© 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.
Outcomes of â‰¤6-month versus 12-month dual antiplatelet therapy after drug-eluting stent implantation: A meta-analysis and meta-regression. - Medicine
The benefit of â‰¤6-month compared with 12-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) placement remains controversial. We performed a meta-analysis and meta-regression of â‰¤6-month versus 12-month DAPT in patients undergoing PCI with DES placement.We conducted electronic database searches of randomized controlled trials (RCTs) comparing DAPT durations after DES placement. For studies with longer follow-up, outcomes at 12 months were identified. Odds ratios and 95% confidence intervals were computed with the Mantel-Haenszel method. Fixed-effect models were used; if heterogeneity (I)â€Š>â€Š40 was identified, effects were obtained with random models.Nine RCTs were included with total nâ€Š=â€Š19,224 patients. No significant differences were observed between â‰¤6-month compared with 12-month DAPT in all-cause mortality (OR 0.87; 95% confidence interval (CI): 0.69-1.11), cardiovascular (CV) mortality (OR 0.89; 95% CI: 0.66-1.21), non-CV mortality (OR 0.85; 95% 0.58-1.24), myocardial infarction (OR 1.10; 95% CI: 0.89-1.37), stroke (OR 0.97; 95% CI: 0.67-1.42), stent thrombosis (ST) (OR 1.37; 95% CI: 0.89-2.10), and target vessel revascularization (OR 0.95; 95% CI: 0.77-1.18). No significant difference in major bleeding (OR 0.72; 95% CI: 0.49-1.05) was observed, though the all-bleeding event rate was significantly lower in the â‰¤6-month DAPT group (OR 0.76; 95% CI: 0.59-0.96). In the meta-regression analysis, a significant association between bleeding events and non-CV mortality with 12-month DAPT was found, as well as between ST and mortality in addition to MI with â‰¤6-month DAPT.DAPT for â‰¤6 months is associated with similar mortality and ischemic outcomes but less bleeding events compared with 12-month DAPT after PCI with DES.
Balloon Valvuloplasty to Predict X-ray Projection Angles that are Perpendicular to Cardiovascular Structures: A TAVI Patient Feasibility Study. - Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
The purpose of this work is to describe methods to measure the 3D angular orientation of cardiovascular structures based on a planar image of a valvuloplasty balloon. These methods facilitate X-ray beam alignment with respect to the anatomy of interest.X-ray beam projections which are perpendicular to the long axis of cardiovascular structures are required to support interventional procedures, including transcatheter aortic valve implant (TAVI).During the TAVI procedure, the 3D angular orientation of the LVOT of 10 patients was measured from a single planar image of an aortic valvuloplasty balloon and the continuous range of X-ray projection angles which are aligned with the aortic valve plane were calculated (research method). Misalignment of the X-ray beam and TAVI valve frame was measured from images of the deployed valve. The accuracy of the research method was compared to clinical standard method to determine appropriate X-ray projection angles, which utilized CT and aortography.Using the clinical standard method, the median misalignment of the X-ray beam and TAVI valve frame was 8.6Â° (range 2.6Â° to 21Â°). Misalignment was reduced to 2.5Â° (range 0Â° to 10Â°) using the research method.The 3D angular orientation of cardiovascular structures can be measured accurately from a single X-ray projection image of a known cardiovascular device contained within the anatomy of interest. For TAVI procedures, improved X-ray beam alignment may help facilitate procedural success. Â© 2016 Wiley Periodicals, Inc.Â© 2016 Wiley Periodicals, Inc.
A meta-analysis and meta-regression of long-term outcomes of transcatheter versus surgical aortic valve replacement for severe aortic stenosis. - International journal of cardiology
Transcatheter aortic valve replacement (TAVR) has emerged as an alternative to surgical aortic-valve replacement (SAVR) for patients with severe symptomatic aortic stenosis (AS) who are at high operative risk. We sought to determine the long-term (â‰¥1year follow-up) safety and efficacy TAVR compared with SAVR in patients with severe AS.A comprehensive search of PubMed, EMBASE, Cochrane Central Register of Controlled Trials, conference proceedings, and relevant Web sites from inception through 10 April 2016.Fifty studies enrolling 44,247 patients met the inclusion criteria. The mean duration follow-up was 21.4months. No difference was found in long-term all-cause mortality (risk ratios (RR), 1.06; 95% confidence interval (CI) 0.91-1.22). There was a significant difference favoring TAVR in the incidence of stroke (RR, 0.82; 95% CI 0.71-0.94), atrial fibrillation (RR, 0.43; 95% CI 0.33-0.54), acute kidney injury (RR, 0.70; 95% CI 0.53-0.92), and major bleeding (RR, 0.57; 95% CI 0.40-0.81). TAVR had significant higher incidence of vascular complications (RR, 2.90; 95% CI 1.87-4.49), aortic regurgitation (RR, 7.00; 95% CI 5.27-9.30), and pacemaker implantation (PPM) (RR, 2.02; 95% CI 1.51-2.68). TAVR demonstrated significantly lower stroke risk compared to SAVR in high-risk patients (RR, 1.49; 95% CI 1.06-2.10); no differences in PPM implantation were observed in intermediate-risk patients (RR, 1.68; 95% CI 0.94-3.00). In a meta-regression analysis, the effect of TAVR baseline clinical features did not affect the long-term all-cause mortality outcome.TAVR and SAVR showed similar long-term survival in patients with severe AS; with important differences in treatment-associated morbidity.Copyright Â© 2016 Elsevier Ireland Ltd. All rights reserved.
Economic and clinical impact of routine weekend catheterization services. - The American journal of managed care
To assess the impact of weekend cardiac catheterization (cath) services for nonemergent inpatients.Retrospective cohort study of patients undergoing cath before and after Saturday cath service availability (CSA).Cohorts included Friday and Saturday admissions with cath (with or without revascularization) on the subsequent Monday from January 1, 2007, to December 31, 2008 (pre-CSA events), and Friday or Saturday admissions undergoing cath the subsequent or same Saturday from January 1, 2009, to December 31, 2010 (post-CSA events). Administrative and registry data provided demographics, comorbidities, percutaneous coronary intervention (PCI) details, adverse events, hospital length of stay (LOS), and inpatient expenditures. We used generalized linear modeling to predict LOS and costs, and logistic regression to estimate the likelihood of adverse events during follow-up.We identified 331 pre-CSA cases (327 patients) and 244 post-CSA cases (243 patients). Cohorts were similar in age (66 years), sex (59% male), and level of comorbidity. PCI use was higher following CSA (42% vs 26%; P <.001), with procedural success accomplished in 95% and 94% of pre- and post-CSA patients, respectively. Adjusted clinical outcomes were similar (odds ratio [OR] for in-hospital mortality, 0.67 post-CSA vs pre-CSA; P = .55; OR for 30-day revascularization, 1.14; P = .68). Models predict an average LOS reduction of 1.7 days following CSA (5.7 vs 4.0 days; P <.001) yet inpatient costs were similar ($24,817 vs $24,753; 95% CI of difference, -$3611 to $3576).Weekend CSA for routine inpatients was clinically safe and effective, and reduced hospital LOS. Similar inpatient costs likely reflect a shift in case mix in this nonrandomized study.
Impact of right ventricular size and function on survival following transcatheter aortic valve replacement. - International journal of cardiology
The impact of pre-procedural RV size and function on outcomes following transcatheter aortic valve replacement (TAVR) is not well established. The aim of this study was to investigate the role of right ventricular size and function on outcomes following TAVR.Between November 2008 and June 2013, 268 consecutive patients (age 80.5Â±7.9years, aortic valve area 0.79Â±0.16cm(2)) with symptomatic severe aortic stenosis (AS) undergoing TAVR at Mayo Clinic were included. Transthoracic echocardiographic quantitative and semiquantitative assessment of RV chamber size and systolic function was performed and included tricuspid annular plane systolic excursion (TAPSE), RV systolic excursion velocity (S'), fractional area change (FAC), RV index of myocardial performance (RIMP). The primary endpoint of all-cause mortality after TAVR was measured and observed in 65 patients (median follow up duration: 412days). Univariate analysis identified semiquantitative RV dilatation (p<0.001) and systolic dysfunction (p=0.013), RV basal dimension (p=0.003) and RV outflow proximal dimension (p=0.031) to be of prognostic significance. After multivariate adjustment, patients with semiquantitative RV dilatation (HR 2.61, 95% CI 1.45-4.65, p=0.002) and larger RV basal dimension (HR 1.07, 95% CI per mm 1.02-1.11, p=0.007) had significantly worse survival even after adjusting for age, sex, Society of Thoracic Surgeons (STS) risk score, left ventricular ejection fraction, tricuspid regurgitation, pulmonary artery systolic pressure, and atrial fibrillation.RV dilatation is an important determinant of postoperative outcomes in patients undergoing TAVR.Copyright Â© 2016 Elsevier Ireland Ltd. All rights reserved.
Assisted care as a baseline patient risk characteristic affecting the outcome of transcatheter aortic valve insertion. - Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
Objective measures of frailty have not been well defined as risk factors for a poor outcome after transcatheter aortic valve insertion. We hypothesized that assisted care as a baseline patient characteristic was a simple objective measure of frailty. We reviewed our experience to assess for an association between assisted care and outcome of operation.We retrospectively reviewed the records of 597 patients operated with transcatheter aortic valve insertion from November 2008 through July 2015. The study cohort included patients with a dichotomous baseline characteristic of receiving assisted care (AC group, nâ€‰=â€‰60, 10.1%) or not receiving assisted care (NC group, nâ€‰=â€‰537, 89.9%). The endpoints of the study were operative stroke/death and 1-year survival.The age of the patients was 80.6â€‰Â±â€‰9.0 years, male sex was present in 349 (58.5%), and STS predicted risk of mortality was 9.2â€‰Â±â€‰6.2%. Alternate access was used in 26 (43.3%) patients in the AC care group and in 220 (41.0%) in the NC group (Pâ€‰=â€‰0.724). Operative stroke/death occurred in 4 (6.7%) patients in the AC group and in 25 (4.7%) in the NC group (Pâ€‰=â€‰0.492). Mortality at 1 year in the AC group was 14.8â€‰Â±â€‰5.2% and in the NC group was 12.9â€‰Â±â€‰1.7%; (Pâ€‰=â€‰0. 250).Assisted care as a baseline patient characteristic does not result in increased operative stroke/death or 1-year mortality in patients following transcatheter aortic valve insertion. Assisted care should not by itself preclude operation. Â© 2016 Wiley Periodicals, Inc.Â© 2016 Wiley Periodicals, Inc.
Clinical Outcomes After Transapical and Transfemoral Transcatheter Aortic Valve Insertion: An Evolving Experience. - The Annals of thoracic surgery
Prior publications note increased adverse events after transapical compared with transfemoral access transcatheter aortic valve insertion (TAVI). We reviewed our TAVI experience to understand the differences in baseline patient characteristics and outcomes associated with the two access methods.The records were reviewed of 567 patients who underwent transfemoral (nÂ = 351, 61.9%) and transapical (nÂ = 216, 38.1%) TAVI from November 2008 through JulyÂ 2015.Compared with patients who underwent transfemoral access, the patients who underwent transapical access were older (82.0 Â± 7.5 versus 79.6 Â± 9.7 years; pÂ = 0.006), had more peripheral vascular disease (78.2% versus 54.7%; p < 0.001), more previous coronary artery bypass graft operations (50.9% versus 32.5%; p < 0.001), and higher Society of Thoracic Surgeons predicted risk ofÂ mortality (9.4% Â± 5.4% versus 8.8% Â± 6.5%; pÂ = 0.032). In-hospital and 30-day mortality rates, however, were similar between the two groups (transapical, nÂ = 7, 3.2%; transfemoral, nÂ = 13, 3.7%; pÂ = 0.772). Follow-up echocardiography in 547 (100.0%) surviving patients at a median of 182 days (interquartile range, 35 to 420) demonstrated less paravalvular regurgitation grade of moderate or greater in patients who underwent transapical access (transapical, nÂ = 6, 2.9%; transfemoral, nÂ =Â 35, 10.4%; pÂ = 0.001) but similar ejection fraction in the two groups (transapical, 55.4% Â± 12.2%; transfemoral, 55.9% Â± 13.0%; pÂ = 0.419). Mortality rates at 1 year (transapical, 19.2% Â± 3.0%; transfemoral,14.7% Â± 3.2%) and 4 years (transapical, 47.4% Â± 6.4%; transfemoral, 42.7% Â± 4.9%) were also similar between the two groups (pÂ = 0.342).Transapical and transfemoral transcatheter aortic valve insertions result in similar operative and longer term mortality rates, despite differences in baseline patient risk. The findings support the concept that access does not influence treatment-related mortality rates.Copyright Â© 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
Experience and complications associated with use of guide extension catheters in percutaneous coronary intervention. - Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
To investigate the utility and safety of the GuideLiner "mother-and-child" catheter system during transradial and transfemoral percutaneous coronary intervention (PCI).In patients with complex coronary anatomy, stent delivery can be challenging and result in procedural failure and complications. The GuideLiner is a coaxial guide extension system designed to enable deep vessel engagement and facilitate device delivery. The purpose of this study was to evaluate procedural success and safety in a series of GuideLiner-facilitated PCI.Single center retrospective study of PCI utilizing the GuideLiner catheter between February 2010 and October 2014. Patients who underwent PCI without GuideLiner use during the same time period were used as controls for comparison.A total of 363 cases of GuideLiner-facilitated PCI were identified from 6,088 unique PCI procedures performed during this same time period. Patients in the GuideLiner group were older (mean age 71.5 vs. 67.8, Pâ€‰<â€‰0.001) and had more multivessel disease (72% vs. 63%, Pâ€‰=â€‰0.001) compared with controls. Type C lesions were present in 78% of GuideLiner cases. Procedural success resulting in successful device delivery with the GuideLiner catheter was 80.2%. Stent deformation associated with GuideLiner use occurred in 2.2% (8/363), with the incidence of this complication decreasing over device iterations. Coronary dissection attributed to GuideLiner occurred in 3.3% (12/363) and became less frequent over the study period.In this consecutive series of GuideLiner supported PCI, the guide extension system enabled procedural success in the majority. A decline in device-associated complications over time may be attributed to operator learning curve, patient selection, and improvement in catheter design. Â© 2015 Wiley Periodicals, Inc.Â© 2015 Wiley Periodicals, Inc.
The Role of Balloon Aortic Valvuloplasty in Patients With Aortic Valve Stenosis and Society of Thoracic Surgeons Risk of 15% or Higher. - The Annals of thoracic surgery
Extreme-risk patients (ie, Society of Thoracic Surgeons [STS] risk 15% or higher) with severe aortic valve stenosis may not obtain mortality benefit from aortic valve replacement (AVR). We reviewed our experience with this group of patients to better understand our triage process and outcomes.We performed a retrospective review of 97 patients with severe aortic valve stenosis and STS risk of 15% or higher treated from 2008 through 2013. The median patient age was 85 years (minimum, 44; maximum, 97 years), and 47 patients (48.5%) were male. The STS risk of mortality was 19.8% (minimum, 15.1%; maximum, 60.9%). Patients were assigned to treatment groups based on the first aortic valve intervention of balloon aortic valvuloplasty (BAV group, 66 [68%]) or de novo AVR (d-AVR group, 31 [32%]).Patients in the BAV group were sicker, withÂ a reduced ejection fraction (0.35 vs 0.57; pÂ = 0.002) and greater prevalence of urgent/emergency operative status (32% vs 10%; pÂ = 0.004) compared with those inÂ the d-AVR group. After BAV, 33 patients (50%) demonstrated clinical improvement and went on to receive subsequent staged AVR after a median of 64 days (minimum, 3; maximum, 390 days). The mortality rate at 2 years was worse in the BAV group (57.3% Â±Â 6.3%) than in the d-AVR group (29.5% Â± 8.3%; pÂ =Â 0.015), but was similar in patients who received BAV followed by staged AVR and de novo AVR (pÂ =Â 0.426).BAV may triage select patients with STS risk 15% or higher who are questionable candidates for AVR. Patients with clinical improvement after BAV experience benefit from staged AVR.Copyright Â© 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
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