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Journal of the American College of Cardiology current issue

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Myocardial Fibrosis in Patients With Primary Mitral Regurgitation With and Without Prolapse
AbstractBackground

Recent studies reported left ventricular (LV) fibrosis in patients with primary mitral regurgitation (MR) thought to be principally due to mitral valve prolapse (MVP).

Objectives

This study sought to evaluate the prevalence, characteristics, and prognostic implications of LV fibrosis in a large cohort of primary MR patients with and without MVP using cardiovascular magnetic resonance (CMR).

Methods

Patients referred for contrast CMR assessment of chronic primary MR were enrolled and underwent comprehensive assessment of cardiac remodeling, severity of MR, and LV replacement fibrosis. Primary MR patients were stratified into: an MVP group if there was >2 mm mitral leaflet displacement on cine-CMR, or a non-MVP group. Patients were followed for arrhythmic events (sudden cardiac death, aborted sudden cardiac arrest, and sustained or inducible ventricular arrhythmia).

Results

A total of 356 primary MR patients (177 MVP and 179 non-MVP) were enrolled. LV fibrosis was more prevalent in the MVP group than the non-MVP group (36.7% vs. 6.7%; p < 0.001). The presence of MVP had the strongest association (odds ratio: 6.82; p < 0.001) with LV fibrosis even after adjustment for clinical variables, measures of cardiac remodeling, and MR severity. During follow-up (median 1,354 days), MVP patients with LV fibrosis had the highest event rate for arrhythmic events.

Conclusions

In primary MR patients, LV fibrosis is more prevalent in MVP than non-MVP, suggesting a unique pathophysiology beyond volume overload in MVP. LV fibrosis in primary MR may represent a risk marker of arrhythmic events.





Mitral Valve Prolapse: A Disease of Valve and Ventricle




Edoxaban in Asian Patients With Atrial Fibrillation: Effectiveness and Safety
AbstractBackground

It is unclear whether edoxaban shows better risk reduction of ischemic stroke, bleeding, and all-cause mortality than warfarin in Asian patients with nonvalvular atrial fibrillation (AF).

Objectives

This study compared the effectiveness and safety of edoxaban with those of warfarin in a Korean population with AF.

Methods

Using the Korean National Health Insurance Service database, we included new users of edoxaban and warfarin in patients with AF from January 2014 to December 2016 (n = 4,200 on edoxaban, and n = 31,565 on warfarin) and analyzed the risk of ischemic stroke, intracranial hemorrhage (ICH), hospitalization for gastrointestinal (GI) bleeding, hospitalization for major bleeding, and all-cause death. The propensity score matching method was used to balance covariates across edoxaban and warfarin users.

Results

We compared a 1:3 propensity score–matched cohort of patients with AF who were new users of edoxaban and warfarin (n = 4,061 and n = 12,183, respectively). Baseline characteristics were balanced between the 2 groups (median age 72 years; median CHA2DS2-VASc [congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke, transient ischemic attack, or thromboembolism, vascular disease, age 65–74 years, sex category (female)] score 3). Edoxaban users had a significantly lower risk of ischemic stroke (hazard ratio [HR]: 0.693; 95% confidence interval [CI]: 0.487 to 0.959), ICH (HR: 0.407; 95% CI: 0.182 to 0.785), hospitalization for GI bleeding (HR: 0.597; 95% CI: 0.363 to 0.930), hospitalization for major bleeding (HR: 0.532; 95% CI: 0.352 to 0.773), and all-cause death (HR: 0.716; 95% CI: 0.549 to 0.918) than warfarin users. All subgroups (age, sex, CHA2DS2-VASc score, renal function, edoxaban dose) showed better clinical outcomes with edoxaban than with warfarin.

Conclusions

In this real-world Asian population with AF, edoxaban might be associated with reduced risk of ischemic stroke, major bleeding, and all-cause death compared with warfarin. These benefits were consistent across various high-risk subgroups.





Edoxabans Journey: From East Asia to the Globe, Back to East Asia




Late Gadolinium Enhancement in Patients With Hypertrophic Cardiomyopathy and Preserved Systolic Function
AbstractBackground

A high proportion of patients with hypertrophic cardiomyopathy (HCM) have evidence of late gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR).

Objectives

This study sought to assess the incremental prognostic utility of LGE in patients with HCM.

Methods

We studied 1,423 consecutive low-/intermediate-risk patients with HCM (age ≥18 years) with preserved left ventricular (LV) ejection fraction (mean age 66 ± 14 years, 60% men) who underwent transthoracic echocardiography (TTE) (including dimensions and LV outflow tract gradients) and CMR (including LGE as a % of LV mass) at our center between January 2008 and December 2015. The primary composite endpoint was sudden cardiac death (SCD) and appropriate implantable cardioverter-defibrillator discharge. The percent 5-year SCD risk score was calculated.

Results

The mean 5-year SCD risk score was 2.3 ± 2.0. Mean maximal LV outflow tract gradient (TTE) was 70 ± 55 mm Hg (median 74 mm Hg [interquartile range (IQR): 10 to 67 mm Hg]); indexed LV mass and LGE (both on CMR) were 91 ± 10 g/m2 and 8.4 ± 12% (IQR: 0% to 19%); 50% had LGE on CMR. Of these, 458 were nonobstructive and 965 were obstructive (of which 686 were underwent myectomy). At 4.7 ± 2.0 years of follow-up, 60 (4%) met the composite endpoint. On quadratic spline analysis, LGE ≥15% was associated with increased risk of composite events. In the obstructive subgroup, on competing risk regression analysis, ≥15% LGE (subhazard ratio: 3.04 [95% confidence interval: 1.48 to 6.10]) was associated with a higher rate and myectomy (subhazard ratio: 0.44 [95% confidence interval: 0.20 to 0.76]) was associated with a lower rate of composite endpoints (both p < 0.01). Similarly, sequential addition of LGE ≥15% and myectomy to % 5-year SCD risk score improved the log likelihood ratios from –227.85 to –219.14 (chi-square 17) and to –215.14 (chi-square 8; both p < 0.01). Association of %LGE with composite events was similar even in myectomy and nonobstructive subgroups.

Conclusions

In low-/intermediate-risk adult patients with HCM (obstructive, myectomy, and nonobstructive subgroups) with preserved systolic function, %LGE was significantly associated with a higher rate of composite endpoint, providing incremental prognostic utility.





Further Refining Risk in Hypertrophic Cardiomyopathy With Late Gadolinium Enhancement by CMR




Long-Term Prognosis of Patients With Takotsubo Syndrome
AbstractBackground

Prognosis of Takotsubo syndrome (TTS) remains controversial due to scarcity of available data. Additionally, the effect of the triggering factors remains elusive.

Objectives

This study compared prognosis between TTS and acute coronary syndrome (ACS) patients and investigated short- and long-term outcomes in TTS based on different triggers.

Methods

Patients with TTS were enrolled from the International Takotsubo Registry. Long-term mortality of patients with TTS was compared to an age- and sex-matched cohort of patients with ACS. In addition, short- and long-term outcomes were compared between different groups according to triggering conditions.

Results

Overall, TTS patients had a comparable long-term mortality risk with ACS patients. Of 1,613 TTS patients, an emotional trigger was detected in 485 patients (30%). Of 630 patients (39%) related to physical triggers, 98 patients (6%) had acute neurologic disorders, while in the other 532 patients (33%), physical activities, medical conditions, or procedures were the triggering conditions. The remaining 498 patients (31%) had no identifiable trigger. TTS patients related to physical stress showed higher mortality rates than ACS patients during long-term follow-up, whereas patients related to emotional stress had better outcomes compared with ACS patients.

Conclusions

Overall, TTS patients had long-term outcomes comparable to age- and sex-matched ACS patients. Also, we demonstrated that TTS can either be benign or a life-threating condition depending on the inciting stress factor. We propose a new classification based on triggers, which can serve as a clinical tool to predict short- and long-term outcomes of TTS. (International Takotsubo Registry [InterTAK Registry]; NCT01947621)





Survival After Takotsubo, Revisited




Deficiency of GATA3-Positive Macrophages Improves Cardiac Function Following Myocardial Infarction or Pressure Overload Hypertrophy
AbstractBackground

Macrophages are highly plastic cells that play an important role in the pathogenesis of cardiovascular disease.

Objectives

This study investigated the role of GATA3-positive macrophages in modulating cardiac function after myocardial infarction (MI) or in response to pressure overload hypertrophy.

Methods

Myeloid-specific GATA3-deficient (mGATA3KO) mice were generated, MI or pressure overload was induced, and cardiac function was determined by echocardiography. GATA3-sufficient Cre mice were used as a control. Immunohistochemical staining, flow cytometry, MILLIPLEX Mouse Cytokine/Chemokine Assay, cultured macrophages, quantitative real-time polymerase chain reaction, and western blot were used to determine the role of GATA3 in macrophages.

Results

GATA3-positive macrophages rapidly accumulated in the infarcted region of the myocardium after acute MI. Deficiency of GATA3-positive macrophages led to a significant improvement of cardiac function in response to acute MI or pressure overload hypertrophy compared with the control mice. This improvement was associated with the presence of a large number of proinflammatory Ly6Chi monocytes/macrophages and fewer reparative Ly6Clo macrophages in the myocardium of mGATA3KO mice compared with control mice. Analysis of serum proteins from the 2 mouse genotypes revealed no major changes in the profile of serum growth factors and cytokines between the 2 mice genotypes before and after MI. GATA3 was found to be specifically and transiently induced by interleukin 4 in cultured macrophages through activity of the proximal promoter, whereas the distal promoter remained silent. In addition, the absence of GATA3 in macrophages markedly attenuated arginase-1 expression in cultured macrophages.

Conclusions

We demonstrated that the presence of GATA3-positive macrophages adversely affects remodeling of the myocardium in response to ischemia or pressure overload, whereas the absence of these macrophages led to a significant improvement in cardiac function. Targeting of signaling pathways that lead to the expression of GATA3 in macrophages may have favorable cardiac outcomes.





Manipulating Macrophage Polarization to Fix the Broken Heart: Challenges and Hopes




Cardiovascular Health Promotion: An Issue That Can No Longer Wait




Cardiovascular Disease Prevention by Diet Modification: JACC Health Promotion Series
Abstract

Reduction in excess calories and improvement in dietary composition may prevent many primary and secondary cardiovascular events. Current guidelines recommend diets high in fruits, vegetables, whole grains, nuts, and legumes; moderate in low-fat dairy and seafood; and low in processed meats, sugar-sweetened beverages, refined grains, and sodium. Supplementation can be useful for some people but cannot replace a good diet. Factors that influence individuals to consume a low-quality diet are myriad and include lack of knowledge, lack of availability, high cost, time scarcity, social and cultural norms, marketing of poor-quality foods, and palatability. Governments should focus on cardiovascular disease as a global threat and enact policies that will reach all levels of society and create a food environment wherein healthy foods are accessible, affordable, and desirable. Health professionals should be proficient in basic nutritional knowledge to promote a sustainable pattern of healthful eating for cardiovascular disease prevention for both healthy individuals and those at higher risk.





His Bundle Pacing
Abstract

Traditional right ventricular (RV) pacing for the management of bradyarrhythmias has been pursued successfully for decades, although there remains debate regarding optimal pacing site with respect to both hemodynamic and clinical outcomes. The deleterious effects of long-term RV apical pacing have been well recognized. This has generated interest in approaches providing more physiological stimulation, namely, His bundle pacing (HBP). This paper reviews the anatomy of the His bundle, early clinical observations, and current approaches to permanent HBP. By stimulating the His-Purkinje network, HBP engages electrical activation of both ventricles and may avoid marked dyssynchrony. Recent studies have also demonstrated the potential of HBP in patients with underlying left bundle branch block and cardiomyopathy. HBP holds promise as an attractive mode to achieve physiological pacing. Widespread adaptation of this technique is dependent on enhancements in technology, as well as further validation of efficacy in large randomized clinical trials.





It Takes a Team to Deliver Optimal Cardiovascular Care




Correlation of Altmetric Attention Score With Article Citations in Cardiovascular Research




Omega-3 Fatty Acids Effect on Post-Myocardial Infarction ST2 Levels for Heart Failure and Myocardial Fibrosis




Infection-Induced Humoral Autoimmunity: A Missing Link in the Interplay Between Pathogens, Dyslipidemia, and Innate Immunity?




Patient-Specific Computer Modeling for the Planning of Transcatheter Mitral Valve Replacement




Reply: Infection and Atherogenesis




Reply: Patient-Specific Computer Modeling for the Planning of Transcatheter Mitral Valve Replacement




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JACC: Cardiovascular Interventions recent issues

JACC: Cardiovascular Interventions RSS feed -- recent issues

First-in-Man Percutaneous Coronary Intervention Using Instantaneous Wave-Free Ratio Roadmap Functionality With Instantaneous Wave-Free Ratio Scout Pullback




Double-Helix Stenting in 1 Superficial Femoral Artery




Prophylactic Ipsilateral Superficial Femoral Artery Access in Patients With Elevated Risk for Femoral Access Complications During Transfemoral Transcatheter Aortic Valve Replacement




Prognostic Implication of Thermodilution Coronary Flow Reserve in Patients Undergoing Fractional Flow Reserve Measurement
AbstractObjectives

This study investigated the prognostic implication of coronary flow reserve (CFR) in patients who underwent fractional flow reserve (FFR) measurement.

Background

Limited data are available regarding the long-term prognosis associated with thermodilution CFR in patients with coronary artery disease.

Methods

A total of 519 patients (737 vessels) who did not undergo revascularization were classified according to FFR and CFR values. Low FFR and low CFR were defined with upper thresholds of 0.8 and 2.0, respectively. FFR and CFR were measured by a pressure-temperature sensor–tipped wire. Clinical outcomes were assessed by the vessel-oriented composite outcome (VOCO) (a composite of cardiac death, vessel-specific myocardial infarction, and vessel-specific revascularization) during 5 years of follow-up.

Results

The categorical agreement (kappa = 0.080; p = 0.024) between FFR and CFR were modest, and 30.6% of the population showed discordant results between FFR and CFR. During 5 years of follow-up, patients with low CFR had a significantly higher risk of VOCO than did those with high CFR (hazard ratio [HR]: 3.171; 95% CI: 1.664 to 6.042; p < 0.001). Among patients with high FFR, there were no differences in clinical risk factor profiles, FFR, or stenosis severity between the high-CFR and low-CFR groups, and low CFR was an independent predictor for VOCO (HR: 4.999; 95% CI: 2.104 to 11.879; p < 0.001). In a 4-group classification according to both FFR and CFR, patients with low FFR and low CFR had the highest risk of VOCO (17.9%; overall p < 0.001).

Conclusions

Patients with low CFR had a significantly higher risk of clinical events during 5 years of follow-up. Low CFR was an independent predictor for patient-oriented composite outcome among patients with high FFR. These results support the value of CFR in patients who undergo FFR measurement. (Clinical, Physical and Prognostic Implication of Microvascular Status; NCT02186093)





Coronary Flow Reserve in the Instantaneous Wave-Free Ratio/Fractional Flow Reserve Era: Too Valuable to Be Neglected




Safety of the Deferral of Coronary Revascularization on the Basis of Instantaneous Wave-Free Ratio and Fractional Flow Reserve Measurements in Stable Coronary Artery Disease and Acute Coronary Syndromes
AbstractObjectives

The aim of this study was to investigate the clinical outcomes of patients deferred from coronary revascularization on the basis of instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) measurements in stable angina pectoris (SAP) and acute coronary syndromes (ACS).

Background

Assessment of coronary stenosis severity with pressure guidewires is recommended to determine the need for myocardial revascularization.

Methods

The safety of deferral of coronary revascularization in the pooled per-protocol population (n = 4,486) of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) and iFR-SWEDEHEART (Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome) randomized clinical trials was investigated. Patients were stratified according to revascularization decision making on the basis of iFR or FFR and to clinical presentation (SAP or ACS). The primary endpoint was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year.

Results

Coronary revascularization was deferred in 2,130 patients. Deferral was performed in 1,117 patients (50%) in the iFR group and 1,013 patients (45%) in the FFR group (p < 0.01). At 1 year, the MACE rate in the deferred population was similar between the iFR and FFR groups (4.12% vs. 4.05%; fully adjusted hazard ratio: 1.13; 95% confidence interval: 0.72 to 1.79; p = 0.60). A clinical presentation with ACS was associated with a higher MACE rate compared with SAP in deferred patients (5.91% vs. 3.64% in ACS and SAP, respectively; fully adjusted hazard ratio: 0.61 in favor of SAP; 95% confidence interval: 0.38 to 0.99; p = 0.04).

Conclusions

Overall, deferral of revascularization is equally safe with both iFR and FFR, with a low MACE rate of about 4%. Lesions were more frequently deferred when iFR was used to assess physiological significance. In deferred patients presenting with ACS, the event rate was significantly increased compared with SAP at 1 year.





Value of Different Physiological Indexes to Defer Coronary Revascularization




Sex Differences in Adenosine-Free Coronary Pressure Indexes: A CONTRAST Substudy
AbstractObjectives

The goal of this study was to investigate sex differences in adenosine-free coronary pressure indexes.

Background

Several adenosine-free coronary pressure wire indexes have been proposed to assess the functional significance of coronary artery lesions; however, there is a theoretical concern that sex differences may affect diagnostic performance because of differences in resting flow and distal myocardial mass.

Methods

In this CONTRAST (Can Contrast Injection Better Approximate FFR Compared to Pure Resting Physiology?) substudy, contrast fractional flow reserve (cFFR), obtained during contrast-induced submaximal hyperemia, the instantaneous wave-free ratio (iFR), and distal/proximal coronary pressure ratio (Pd/Pa) were compared with fractional flow reserve (FFR) in 547 men and 216 women. Using FFR ≤0.8 as a reference, the diagnostic performance of each index was compared.

Results

Men and women had similar diameter stenosis (p = 0.78), but women were less likely to have FFR ≤0.80 than men (42.5% vs. 51.5%, p = 0.04). Sensitivity was similar among cFFR, iFR, and Pd/Pa when comparing women and men, respectively (cFFR, 77.5% vs. 75.3%; p = 0.69; iFR, 84.9% vs. 79.4%; p = 0.30; Pd/Pa, 78.8% vs. 77.3%; p = 0.78). cFFR was more specific than iFR or Pd/Pa regardless of sex (cFFR, 94.3% vs. 95.8%; p = 0.56; iFR, 75.6% vs. 80.1%; p = 0.38; Pd/Pa, 80.6% vs. 78.7%; p = 0.69). By receiver-operating characteristic curve analysis, cFFR provided better diagnostic accuracy than resting indexes irrespective of sex (p ≤ 0.0001).

Conclusions

Despite the theoretical concern, the diagnostic sensitivity and specificity of cFFR, iFR, and Pd/Pa did not differ between the sexes. Irrespective of sex, cFFR provides the best diagnostic performance.





Functional Significance of Epicardial Coronary Artery Disease in Women: One Piece of the Puzzle




New Volumetric Analysis Method for Stent Expansion and its Correlation With Final Fractional Flow Reserve and Clinical Outcome: An ILUMIEN I Substudy
AbstractObjectives

This study sought to compare conventional methodology (CM) with a newly described optical coherence tomography (OCT)-derived volumetric stent expansion analysis in terms of fractional flow reserve (FFR)-derived physiology and device-oriented composite endpoints (DoCE).

Background

The analysis of coronary stent expansion with intracoronary imaging has used CM that relies on the analysis of selected single cross-sections for several decades. The introduction of OCT with its ability to perform semiautomated volumetric analysis opens opportunities to redefine optimal stent expansion.

Methods

A total of 291 lesions treated with post-stent OCT and FFR were enrolled. The expansion index was calculated by using a novel volumetric algorithm and was defined as: ([actual lumen area / ideal lumen area] x 100) for each frame of the stented segment. The minimum expansion index (MEI) was defined as the minimum value of expansion index along the entire stented segment. MEI and conventional lumen expansion metrics were compared for the ability to predict post-stent low FFR (<0.90) and DoCE at 1 year.

Results

There was a stronger correlation between MEI and final FFR, compared with CM and final FFR (r = 0.690; p < 0.001) versus (r = 0.165; p = 0.044). MEI was significantly lower in patients with DoCE than those without DoCE (72.18 ± 8.23% vs. 81.48 ± 11.03%; p < 0.001), although stent expansion by CM was similar between patients with and without DoCE (85.05 ± 22.19% and 83.73 ± 17.52%; p = 0.858), respectively.

Conclusions

OCT analysis of stent expansion with a newly described volumetric method, but not with CM, yielded data that were predictive of both an acute improvement in FFR-derived physiology and DoCE.





Another Chapter in the Continuing Saga of "Precision Percutaneous Coronary Intervention"




Evolving Routine Standards in Invasive Hemodynamic Assessment of Coronary Stenosis: The Nationwide Italian SICI-GISE Cross-Sectional ERIS Study
AbstractObjectives

The aims of the ERIS (Evolving Routine Standards of FFR Use) study are to describe the current use of invasive coronary physiology assessment and discern the reasons for its nonuse in daily practice.

Background

Adoption of coronary physiology guidance in the catheterization laboratory varies among countries, centers, and operators.

Methods

ERIS is an investigator-driven, nationwide, prospective, cross-sectional study involving 76 Italian catheterization laboratories. Each center had a 60-day window to include consecutive cases that fulfilled the inclusion and exclusion criteria. Two pre-specified groups were enrolled: 1) patients who had operators apply fractional flow reserve or instantaneous wave-free ratio assessment (physiology assessment group); and 2) patients who had operators decide not to perform fractional flow reserve or instantaneous wave-free ratio assessment, although the patients met the inclusion and exclusion criteria (visual estimation group).

Results

Overall, 1,858 cases were included (physiology assessment group, n = 1,177; visual estimation group, n = 681). Physiology-based guidance was used in 7% and 13% of the total volume of angiographic and percutaneous coronary interventions, respectively. Its use was in line with European and American guidelines in 48% of the cases (n = 569). Physiology guidance was used in a consistent number of patients with acute coronary syndromes (n = 529 [45%]). The main reason for not using physiology guidance was the operator’s confidence that clinical and angiographic data alone were sufficient.

Conclusions

Use of coronary physiology assessment in daily practice meets the current guideline indications in approximately 50% of cases. The major limiting factor for the adoption of physiology guidance was the operator’s confidence in visual assessment alone. (Evolving Routine Standards of FFR Use [ERIS]; NCT03082989)





Coronary Psychology: Do You Believe?




Arrhythmic Burden as Determined by Ambulatory Continuous Cardiac Monitoring in Patients With New-Onset Persistent Left Bundle Branch Block Following Transcatheter Aortic Valve Replacement: The MARE Study
AbstractObjectives

The authors sought to determine: 1) the global arrhythmic burden; 2) the rate of arrhythmias leading to a treatment change; and 3) the incidence of high-degree atrioventricular block (HAVB) at 12-month follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR).

Background

Controversial data exist on the occurrence of significant arrhythmias in patients with LBBB post-TAVR.

Methods

This was a multicenter prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR with the balloon-expandable SAPIEN XT/3 valve (n = 53), or the self-expanding CoreValve/Evolut R system (n = 50). An implantable cardiac monitor (Reveal XT, Reveal Linq) was implanted at 4 (3 to 6) days post-TAVR, and patients had continuous electrocardiogram monitoring for 12 months. All arrhythmic events were adjudicated in a central electrocardiography core lab. Primary endpoints were the incidence of arrhythmias leading to a treatment change, and the incidence of HAVB at 12-month follow-up.

Results

A total of 1,553 new arrhythmic events were detected in 44 patients (1,443 episodes of tachyarrhythmia in 26 patients [atrial fibrillation/flutter/atrial tachycardia: 1,427, ventricular tachycardia 16]; 110 episodes of bradyarrhythmia in 21 patients [HAVB 54, severe bradycardia 56]). All arrhythmic events were silent in 34 patients (77%), the arrhythmic event led to a treatment change in 19 patients (18%), and 11 patients (11%) required pacemaker or implantable cardioverter-defibrillator implantation (due to HAVB, severe bradycardia, or ventricular tachycardia episodes in 9, 1, and 1 patient, respectively). A total of 12 patients died at 1-year follow-up, 1 from sudden death.

Conclusions

A high incidence of arrhythmic events was observed at 1-year follow-up in close to one-half of the patients with LBBB post-TAVR. Significant bradyarrhythmias occurred in one-fifth of the patients, and PPM was required in nearly one-half of them. These data support the use of a cardiac monitoring device for close follow-up and expediting the initiation of treatment in this challenging group of patients. (Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation [MARE study]: NCT02153307)





Arrhythmias and Conduction Disturbances Following Transcatheter Aortic Valve Replacement: Out of Sight, Out of Mind?




Immediate Post-Procedural 12-Lead Electrocardiography as Predictor of Late Conduction Defects After Transcatheter Aortic Valve Replacement
AbstractObjectives

The aim of this study was to use a 12-lead electrocardiogram obtained immediately post–transcatheter aortic valve replacement (TAVR) to identify predictors of late high-degree conduction defect (HD-CD) within 30 days after TAVR.

Background

There are limited data on risk factors for the development of late HD-CD and the need to retain the temporary pacemaker after TAVR.

Methods

A single-center study was conducted including 467 consecutive patients, without pre-procedural pacemakers, undergoing TAVR.

Results

Self-expandable, mechanical, or balloon-expandable heart valves were implanted in 328 (70%), 61 (13%), and 78 (17%) patients, respectively. For patients in sinus rhythm without right bundle branch block, late HD-CD developed in 0 of 70 patients (0%; 95% confidence interval [CI]: 0% to 5.1%) with PR interval <200 ms and QRS interval <120 ms and in 5 of 109 patients (4.6%; 95% CI: 1.5% to 10.4%; all with sufficient escape rhythm) with PR interval <240 ms and QRS interval <150 ms. Late HD-CD developed in 14 of 101 patients (13.9%; 95% CI: 7.8% to 22.2%; 6 with insufficient escape rhythm [5.9%; 95% CI: 2.2% to 12.5%]) with PR interval ≥240 ms or QRS interval ≥150 ms. Furthermore, late HD-CD developed in 3 of 49 patients (6.1%; 95% CI: 1.3% to 16.9%; all with sufficient escape rhythm) and in 3 of 30 patients (10.0%; 95% CI: 2.1% to 26.5%; 2 with insufficient escape rhythm [6.7%; 95% CI: 0.8% to 22.1%]) with atrial fibrillation and no right bundle branch block with QRS interval <140 and ≥140 ms, respectively.

Conclusions

On the basis of immediate post-TAVR 12-lead electrocardiography, removing the temporary pacemaker immediately following TAVR is potentially safe in patients without right bundle branch block who are: 1) in sinus rhythm with PR interval <240 ms and QRS interval <150 ms; or 2) in atrial fibrillation with a QRS interval <140 ms.





Predictors of Advanced Conduction Disturbances Requiring a Late (>=48 H) Permanent Pacemaker Following Transcatheter Aortic Valve Replacement
AbstractObjectives

This study sought to determine predictors of advanced conduction disturbances requiring late (≥48 h) permanent pacemaker replacement (PPM) after transcatheter aortic valve replacement (TAVR).

Methods

Data of consecutive patients were identified by retrospective review of a TAVR database of a single center in Milan, Italy, between October 2007 and July 2015. We defined delta PR (PR) and delta QRS (QRS) interval as the difference between the last PR and QRS length available 48 h after TAVR and the baseline PR and QRS length.

Results

Overall population included 740 patients. We excluded 78 patients who already had a PPM and 51 patients who received a PPM <48 h after TAVR. The final analysis included 611 patients. Fifty-four patients (8.8%) developed an advanced conduction disturbance requiring PPM ≥48 h following TAVR. Patients who required a late PPM implant had a wider QRS width (113 ± 25 ms vs. 105 ± 23 ms; p = 0.009) and a higher prevalence of baseline right bundle branch block (12.9% vs. 5.3%; p = 0.026) and were more likely to have a self-expandable valve implanted (51.8% vs. 31.9%; p = 0.003). The PR was 40 ± 51 ms (p = 0.0001) and the QRS was 22 ± 61 ms (p = 0.001). Multivariable analysis revealed that baseline right bundle branch block (odds ratio: 3.56; 95% confidence interval: 1.07 to 11.77; p = 0.037) and PR (odds ratio for each 10-ms increase: 1.31; 95% confidence interval: 1.18 to 1.45; p = 0.0001) are independent predictors of delayed advanced conduction disturbances.

Conclusions

This analysis showed that baseline right bundle branch block and the amount of increase of PR length after TAVR are independent predictors of late (≥48 h) advanced conduction disturbances requiring PPM replacement after TAVR in this cohort. A simple ECG analysis could help in detecting potentially lethal advanced conduction disturbances that could occur more than 48 h after TAVR.





Disarming the Ticking Time Bomb: Post-Procedure Electrocardiography Predictors of High-Degree Conduction Disturbances After Transcatheter Aortic Valve Replacement




Resting Indexes in the Functional Assessment of Left Main and Left Anterior Descending Coronary Stenoses: A Case for Caution




Emergent Percutaneous Closure of Left Ventricular Free Wall Perforation During Transcatheter Aortic Valve Replacement




Predicting Futility for Transcatheter Aortic Valve Replacement Procedures: Where Do We Stand?




Frailty Scales in Transcatheter Aortic Valve Replacement: Incremental Body of Evidence




Reply: Frailty Scales in Transcatheter Aortic Valve Replacement Incremental Body of Evidence




In Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention, One Size Cannot Fit All




Reply: In Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention, One Size Cannot Fit All




Strong Bias Toward Performing Percutaneous Coronary Intervention in Patients With Chronic Total Occlusion Despite Lack of Important Benefit at a Very High Cost and Risk to the Patient




Reply: Strong Bias Toward Performing Percutaneous Coronary Intervention in Patients With Chronic Total Occlusion Despite Lack of Important Benefit at a Very High Cost and Risk to the Patient




Percutaneous Coronary Intervention Versus Robotic-Assisted Coronary Artery Bypass for Left Anterior Descending Artery Chronic Total Occlusion




Percutaneous Transhepatic Mitral Valve Repair With the MitraClip System




Transcatheter Closure of a Sinus Venosus Atrial Septal Defect Via Transhepatic Access




Porous CARDIOFORM Septal Occluder Balloons Within the Right Atrial Cavity




Angiography Alone Versus Angiography Plus Optical Coherence Tomography to Guide Percutaneous Coronary Intervention: Outcomes From the Pan-London PCI Cohort
AbstractObjectives

This study aimed to determine the effect on long-term survival of using optical coherence tomography (OCT) during percutaneous coronary intervention (PCI).

Background

Angiographic guidance for PCI has substantial limitations. The superior spatial resolution of OCT could translate into meaningful clinical benefits, although limited data exist to date about their effect on clinical endpoints.

Methods

This was a cohort study based on the Pan-London (United Kingdom) PCI registry, which includes 123,764 patients who underwent PCI in National Health Service hospitals in London between 2005 and 2015. Patients undergoing primary PCI or pressure wire use were excluded leaving 87,166 patients in the study. The primary endpoint was all-cause mortality at a median of 4.8 years.

Results

OCT was used in 1,149 (1.3%) patients, intravascular ultrasound (IVUS) was used in 10,971 (12.6%) patients, and angiography alone in the remaining 75,046 patients. Overall OCT rates increased over time (p < 0.0001), with variation in rates between centers (p = 0.002). The mean stent length was shortest in the angiography-guided group, longer in the IVUS-guided group, and longest in the OCT-guided group. OCT-guided procedures were associated with greater procedural success rates and reduced in-hospital MACE rates. A significant difference in mortality was observed between patients who underwent OCT-guided PCI (7.7%) compared with patients who underwent either IVUS-guided (12.2%) or angiography-guided (15.7%; p < 0.0001) PCI, with differences seen for both elective (p < 0.0001) and acute coronary syndrome subgroups (p = 0.0024). Overall this difference persisted after multivariate Cox analysis (hazard ratio [HR]: 0.48; 95% confidence interval [CI]: 0.26 to 0.81; p = 0.001) and propensity matching (hazard ratio: 0.39; 95% CI: 0.21 to 0.77; p = 0.0008; OCT vs. angiography-alone cohort), with no difference in matched OCT and IVUS cohorts (HR: 0.88; 95% CI: 0.61 to 1.38; p = 0.43).

Conclusions

In this large observational study, OCT-guided PCI was associated with improved procedural outcomes, in-hospital events, and long-term survival compared with standard angiography-guided PCI.





Will Optical Coherence Tomography Become the Standard Imaging Tool for Percutaneous Coronary Intervention Guidance?




The Hybrid Approach to Chronic Total Occlusion Percutaneous Coronary Intervention: Update From the PROGRESS CTO Registry
AbstractObjectives

The aim of this study was to determine the techniques and outcomes of hybrid chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in a diverse group of patients and operators on 2 continents.

Background

CTO PCI has been evolving with constant improvement of equipment and techniques.

Methods

Contemporary outcomes of CTO PCI were examined by analyzing the clinical, angiographic, and procedural characteristics of 3,122 CTO interventions performed in 3,055 patients at 20 centers in the United States, Europe, and Russia.

Results

The mean age was 65 ± 10 years, and 85% of the patients were men, with high prevalence of diabetes (43%), prior myocardial infarction (46%), prior coronary artery bypass graft surgery (33%), and prior PCI (65%). The CTO target vessels were the right coronary artery (55%), left anterior descending coronary artery (24%), and left circumflex coronary artery (20%). The mean J-CTO (Multicenter Chronic Total Occlusion Registry of Japan) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) scores were 2.4 ± 1.3 and 1.3 ± 1.0, respectively. The overall technical and procedural success rate was 87% and 85%, respectively, and the rate of in-hospital major complications was 3.0%. The final successful crossing strategy was antegrade wire escalation in 52.0%, retrograde in 27.1%, and antegrade dissection re-entry in 20.9%; >1 crossing strategy was required in 40.9%. Median contrast volume, air kerma radiation dose, and procedure and fluoroscopy time were 270 ml (interquartile range: 200 to 360 ml), 2.9 Gy (interquartile range: 1.7 to 4.7 Gy), 123 min (interquartile range: 81 to 188 min) and 47 min (interquartile range: 29 to 77 min), respectively.

Conclusions

CTO PCI is currently being performed with high success and acceptable complication rates among various experienced centers in the United States, Europe, and Russia. (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention [PROGRESS CTO]; NCT02061436)





Percutaneous Coronary Intervention of Chronic Total Occlusions: Conquering the Final Frontier




Neoatherosclerosis in Patients With Coronary Stent Thrombosis: Findings From Optical Coherence Tomography Imaging (A Report of the PRESTIGE Consortium)
AbstractObjectives

The purpose of this study was to assess neoatherosclerosis in a registry of prospectively enrolled patients presenting with stent thrombosis using optical coherence tomography.

Background

In-stent neoatherosclerosis was recently identified as a novel disease manifestation of atherosclerosis after coronary stent implantation.

Methods

Angiography and intravascular optical coherence tomography were used to investigate etiologic factors of neoatherosclerosis in patients presenting with stent thrombosis >1 year after implantation (very late stent thrombosis [VLST]). Clinical data were collected according to a standardized protocol. Optical coherence tomographic acquisitions were analyzed in a core laboratory. Cox regression analysis was performed to identify factors associated with the formation of neoatherosclerosis and plaque rupture as a function of time.

Results

Optical coherence tomography was performed in 134 patients presenting with VLST. A total of 58 lesions in 58 patients with neoatherosclerosis were compared with 76 lesions in 76 patients without neoatherosclerosis. Baseline characteristics were similar between groups. In-stent plaque rupture was the most frequent cause (31%) in all patients presenting with VLST. In patients with neoatherosclerosis, in-stent plaque rupture was identified as the cause of VLST in 40 cases (69%), whereas uncovered stent struts (n = 22 [29%]) was the most frequent cause in patients without neoatherosclerosis. Macrophage infiltration was significantly more frequent in optical coherence tomographic frames with plaque rupture compared with those without (50.2% vs. 22.2%; p < 0.0001), whereas calcification was more often observed in frames without plaque rupture (17.2% vs. 4%; p < 0.0001). Implantation of a drug-eluting stent was significantly associated with the formation of neoatherosclerosis (p = 0.02), whereas previous myocardial infarction on index percutaneous coronary intervention was identified as a significant risk factor for plaque rupture in patients with neoatherosclerosis (p = 0.003). No significant difference was observed in thrombus composition between patients with or without neoatherosclerosis.

Conclusions

Neoatherosclerosis was frequently observed in patients with VLST. Implantation of a drug-eluting stent was significantly associated with neoatherosclerosis formation. In-stent plaque rupture was the prevailing pathological mechanism and often occurred in patients with neoatherosclerosis and previous myocardial infarction at index percutaneous coronary intervention. Increased macrophage infiltration heralded plaque vulnerability in our study and might serve as an important indicator.





In-Stent Neoatherosclerosis and Very Late Stent Thrombosis: An Endless Fight Against Atherosclerosis




Discharge Against Medical Advice After Percutaneous Coronary Intervention in the United States
AbstractObjectives

This study aimed to evaluate discharge against medical advice (DAMA) in percutaneous coronary intervention (PCI) and how DAMA affects readmissions.

Background

DAMA is infrequent but associated with poor patient outcomes. DAMA in the context of PCI has not been described in the published reports.

Methods

The authors analyzed patients in the Nationwide Readmission Database between 2010 and 2014 with a PCI procedure who were either discharged home or against medical advice. The primary endpoint was all-cause 30-day readmissions and their causes. Descriptive statistics were used to compare DAMA with patients discharged home, and multiple logistic regressions were used to determine patient characteristics associated with DAMA and readmission.

Results

Among the 2,021,104 patients in the analysis, the proportion of patients who DAMA was 0.5% (n = 10,049). The 30-day readmission rate for patients who were DAMA and those discharged home was 16.8% and 8.5%, respectively (p < 0.001). Important predictors of DAMA included diagnosis of acute myocardial infarction (odds ratio [OR]: 1.37; 95% confidence interval [CI]: 1.25 to 1.51; p < 0.001), smoking (OR: 1.71; 95% CI: 1.57 to 1.86; p < 0.001), drug abuse (OR: 1.82; 95% CI: 1.60 to 2.06; p < 0.001), and alcohol misuse (OR: 1.53; 95% CI: 1.32 to 1.78; p < 0.001). DAMA was the strongest predictor for readmission (OR: 1.89; 95% CI: 1.71 to 2.08; p < 0.001). DAMA patients were more likely to have neuropsychiatric reasons for noncardiac causes of readmission (8.3% vs. 2.4%) and acute myocardial infarction for cardiac causes of readmission (39.4% vs. 19.5%) compared with patients discharged home.

Conclusions

DAMA occurs in approximately 0.5% of patients following PCI and is strongly associated with readmission within 30 days. Interventions should be developed to reduce DAMA in high-risk groups and initiate interventions to avoid complications and readmission when it occurs.





Post-Percutaneous Coronary Intervention Discharge Against Medical Advice: Infrequent But Deadly




The SAVI-TF Registry: 1-Year Outcomes of the European Post-Market Registry Using the ACURATE neo Transcatheter Heart Valve Under Real-World Conditions in 1,000 Patients
AbstractObjectives

The SAVI-TF (Symetis ACURATE neo Valve Implantation Using Transfemoral Access) registry was initiated to study the ACURATE neo transcatheter heart valve in a large patient population treated under real-world conditions.

Background

The self-expanding, supra-annular ACURATE neo prosthesis is a transcatheter heart valve that gained the Conformité Européene mark in 2014, but only limited clinical data are available so far.

Methods

This prospective, multicenter registry enrolled 1,000 patients at 25 European centers who were followed for 1 year post-procedure.

Results

Mean patient age was 81.1 ± 5.2 years; mean logistic European System for Cardiac Operative Risk Evaluation I score, European System for Cardiac Operative Risk Evaluation II score, and Society of Thoracic Surgeons score were 18.1 ± 12.5%, 6.6 ± 7.5%, and 6.0 ± 5.6%, respectively. At 1 year, 8.0% (95% confidence interval [CI]: 6.3% to 9.7%) of patients had died, 2.3% (95% CI: 1.3% to 3.2%) had disabling strokes, and 9.9% (95% CI: 8.1% to 11.8%) had permanent pacemaker implantations. Through 1 year, 5 reinterventions (0.5%; 95% CI: 0.1% to 1.0%) were performed: 3 valve-in-valve and 2 surgical aortic valve replacements. Mean effective orifice area was 1.84 ± 0.43 cm2, mean gradient was 7.3 ± 3.7 mm Hg, and greater than mild paravalvular leakage was observed in 3.6% of patients.

Conclusions

Transfemoral implantation of the ACURATE neo prosthesis resulted in favorable 1-year clinical and echocardiographic outcomes with very low mortality and new pacemaker rates.





Midterm Outcomes With the Self-Expanding ACURATE neo Aortic Bioprosthesis: The "Bumblebee Paradox" in Transcatheter Aortic Valve Replacement




Impact of Aortic Root Anatomy and Geometry on Paravalvular Leak in Transcatheter Aortic Valve Replacement With Extremely Large Annuli Using the Edwards SAPIEN 3 Valve
AbstractObjectives

The aim of this study was to determine factors affecting paravalvular leak (PVL) in transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli.

Background

The largest recommended annular area for the 29-mm S3 is 683 mm2. However, experience with S3 TAVR in annuli >683 mm2 has not been widely reported.

Methods

From December 2013 to July 2017, 74 patients across 16 centers with mean area 721 ± 38 mm2 (range: 684 to 852 mm2) underwent S3 TAVR. The transfemoral approach was used in 95%, and 39% were under conscious sedation. Patient, anatomic, and procedural characteristics were retrospectively analyzed. Valve Academic Research Consortium–2 outcomes were reported.

Results

Procedural success was 100%, with 2 deaths, 1 stroke, and 2 major vascular complications at 30 days. Post-dilatation occurred in 32%, with final balloon overfilling (1 to 5 ml extra) in 70% of patients. Implantation depth averaged 22.3 ± 12.4% at the noncoronary cusp and 20.7 ± 9.9% at the left coronary cusp. New left bundle branch block occurred in 17%, and 6.3% required new permanent pacemakers. Thirty-day echocardiography showed mild PVL in 22.3%, 6.9% moderate, and none severe. There was no annular rupture or coronary obstruction. Mild or greater PVL was associated with larger maximum annular and left ventricular outflow tract (LVOT) diameters, larger LVOT area and perimeter, LVOT area greater than annular area, and higher annular eccentricity.

Conclusions

TAVR with the 29-mm S3 valve beyond the recommended range by overexpansion is safe, with acceptable PVL and pacemaker rates. Larger LVOTs and more eccentric annuli were associated with more PVL. Longer term follow-up will be needed to determine durability of S3 TAVR in this population.





Transcatheter Aortic Valve Replacement in Extremely Large Annuli: (Over)expanding Bioprosthetic Technology to the Limits?




Contemporary Trends and Comparative Outcomes With Adjunctive Inferior Vena Cava Filter Placement in Patients Undergoing Catheter-Directed Thrombolysis for Deep Vein Thrombosis in the United States: Insights From the National Inpatient Sample
AbstractObjectives

The aim of this study was to investigate the contemporary trends and comparative effectiveness of adjunctive inferior vena cava filter (IVCF) placement in patients undergoing catheter-directed thrombolysis (CDT) for treatment of proximal lower extremity or caval deep vein thrombosis.

Background

CDT is being increasingly used in the management of proximal deep vein thrombosis. Although a significant number of patients treated with CDT undergo adjunctive IVCF placement, the benefit of this practice remains unknown.

Methods

The National Inpatient Sample database was used to identify all patients with proximal or caval deep vein thrombosis who underwent CDT (with and without adjunctive IVCF placement) in the United States between January 2005 and December 2013. A propensity score–matching algorithm was then used to derive 2 matched groups of patients (IVCF and no IVCF) for comparative outcomes (mortality and major and minor bleeding) and resource use analysis.

Results

Of the 7,119 patients treated with CDT, 2,421 (34%) received IVCFs. There was no significant difference in in-hospital mortality (0.7% vs 1.0%; p = 0.20), procedure-related hemorrhage (1.4% vs. 1.0%; p = 0.23), or intracranial hemorrhage (0.7% vs. 0.6%; p = 0.70) between the IVCF (n = 2,259) and no-IVCF (n = 2,259) groups, respectively. Patients undergoing IVCF placement had higher rates of hematoma (3.4% vs 2.1%; p = 0.009), higher in-hospital charges ($104,049 ± 75,572 vs. $92,881 ± 80,194; p < 0.001) and increased length of stay (7.3 ± 5.6 days vs. 6.9 ± 6.9 days; p = 0.046) compared with the no-IVCF group.

Conclusions

This nationwide observational study suggests that one-third of all patients undergoing CDT receive IVCFs. IVCF use was not associated with a decrease in in-hospital mortality but was associated with higher inpatient charges and longer length of stay.





Inferior Vena Cava Filter Placement With Catheter-Directed Lysis: How Did We Get to This Point?




A Randomized Trial of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Intermediate-Risk Pulmonary Embolism: The OPTALYSE PE Trial
AbstractObjectives

The aim of this study was to determine the lowest optimal tissue plasminogen activator (tPA) dose and delivery duration using ultrasound-facilitated catheter-directed thrombolysis (USCDT) for the treatment of acute intermediate-risk (submassive) pulmonary embolism.

Background

Previous trials of USCDT used tPA over 12 to 24 h at doses of 20 to 24 mg for acute pulmonary embolism.

Methods

Hemodynamically stable adults with acute intermediate-risk pulmonary embolism documented by computed tomographic angiography were randomized into this prospective multicenter, parallel-group trial. Patients received treatment with 1 of 4 USCDT regimens. The tPA dose ranged from 4 to 12 mg per lung and infusion duration from 2 to 6 h. The primary efficacy endpoint was reduction in right ventricular–to–left ventricular diameter ratio by computed tomographic angiography. A major secondary endpoint was embolic burden by refined modified Miller score, measured on computed tomographic angiography 48 h after initiation of USCDT.

Results

One hundred one patients were randomized, and improvements in right ventricular–to–left ventricular diameter ratio were as follows: arm 1 (4 mg/lung/2 h), 0.40 (24%; p = 0.0001); arm 2 (4 mg/lung/4 h), 0.35 (22.6%; p = 0.0001); arm 3 (6 mg/lung/6 h), 0.42 (26.3%; p = 0.0001); and arm 4 (12 mg/lung/6 h), 0.48 (25.5%; p = 0.0001). Improvement in refined modified Miller score was also seen in all groups. Four patients experienced major bleeding (4%). Of 2 intracranial hemorrhage events, 1 was attributed to tPA delivered by USCDT.

Conclusions

Treatment with USCDT using a shorter delivery duration and lower-dose tPA was associated with improved right ventricular function and reduced clot burden compared with baseline. The major bleeding rate was low, but 1 intracranial hemorrhage event due to tPA delivered by USCDT did occur.





The OPTALYSE PE Trial: Another Step Toward Understanding the Truth About Catheter-Directed Thrombolysis for Submassive Pulmonary Embolism




Optical Coherence Tomographic Features of Unstable Coronary Lesions Corresponding to Histopathological Intraplaque Hemorrhage Evaluated by Directional Coronary Atherectomy Specimens




MitraClip Implantation to Treat Early Recurrence of Mitral Regurgitation After Percutaneous Direct Annuloplasty With Cardioband




Early Angiography Use in Patients With Non-ST-Segment Elevation Myocardial Infarction in the United States: Focus on Elderly Patients




Does Late Lumen Loss Represent a Measure of the Efficacy of Bioresorbable Scaffolds?




Dont Leave the Back Door Open




Reply: Dont Leave the Back Door Open




Coronary Artery Intraplaque Microvessels by Optical Coherence Tomography Correlate With Vulnerable Plaque and Predict Clinical Outcomes in Patients With Ischemic Angina




Real-Time Detection of an Acute Cerebral Thrombotic Occlusion During a Transcatheter Valve Intervention




Subclinical Leaflet Thrombosis After Transcatheter Mitral Valve-in-Ring Implantation




Transcatheter Aortic Valve Replacement on an Aortic Mechanical Valve




Management of Coronary Artery Aneurysms
Abstract

Aneurysmal dilation of coronary arteries is observed in up to 5% of patients undergoing coronary angiography. Due to their poorly elucidated underlying mechanisms, their variable presentations, and the lack of largescale outcome data on their various treatment modalities, coronary artery aneurysms and coronary ectasia pose a challenge to the managing clinician. This paper aims to provide a succinct review of aneurysmal coronary disease, with a special emphasis on the challenges associated with its interventional treatment.





Outcomes After Left Main Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting According to Lesion Site: Results From the EXCEL Trial
AbstractObjectives

The authors sought to determine the extent to which the site of the left main coronary artery (LM) lesion (distal bifurcation versus ostial/shaft) influences the outcomes of revascularization with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG).

Background

Among 1,905 patients with LM disease and site-assessed SYNTAX scores of <32 randomized in the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, revascularization with PCI and CABG resulted in similar rates of the composite primary endpoint of death, myocardial infarction (MI), or stroke at 3 years.

Methods

Outcomes from the randomized EXCEL trial were analyzed according to the presence of angiographic core laboratory–determined diameter stenosis ≥50% involving the distal LM bifurcation (n = 1,559; 84.2%) versus disease isolated to the LM ostium or shaft (n = 293; 15.8%).

Results

At 3 years, there were no significant differences between PCI and CABG for the primary composite endpoint of death, MI, or stroke for treatment of both distal LM bifurcation disease (15.6% vs. 14.9%, odds ratio [OR]: 1.08, 95% confidence interval [CI]: 0.81 to 1.42; p = 0.61) and isolated LM ostial/shaft disease (12.4% vs. 13.5%, OR: 0.90, 95% CI: 0.45 to 1.81; p = 0.77) (pinteraction = 0.65). However, at 3 years, ischemia-driven revascularization occurred more frequently after PCI than CABG in patients with LM distal bifurcation disease (13.0% vs. 7.2%, OR: 2.00, 95% CI: 1.41 to 2.85; p = 0.0001), but were not significantly different in patients with disease only at the LM ostium or shaft (9.7% vs. 8.4%, OR: 1.18, 95% CI: 0.52 to 2.69; p = 0.68) (pinteraction = 0.25).

Conclusions

In the EXCEL trial, PCI and CABG resulted in comparable rates of death, MI, or stroke at 3 years for treatment of LM disease, including those with distal LM bifurcation disease. Repeat revascularization rates during follow-up after PCI compared with CABG were greater for lesions in the distal LM bifurcation but were similar for disease isolated to the LM ostium or shaft.





Outcomes After Coronary Stenting or Bypass Surgery for Men and Women With Unprotected Left Main Disease: The EXCEL Trial
AbstractObjectives

The aim of the present study was to assess outcomes after coronary artery bypass grafting surgery (CABG) and percutaneous coronary intervention (PCI) according to sex in a large randomized trial of patients with unprotected left main disease.

Background

In the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial, sex had a significant interaction effect with revascularization strategy, and women had an overall higher mortality when treated with PCI than CABG.

Methods

The EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial was a multinational randomized trial that compared PCI with everolimus-eluting stents and CABG in patients with unprotected left main disease. The primary endpoint was the composite of all-cause death, myocardial infarction, or stroke at 3 years.

Results

Of 1,905 patients randomized, 1,464 (76.9%) were men and 441 (23.1%) were women. Compared with men, women were older; had higher prevalence rates of hypertension, hyperlipidemia, and diabetes; and were less commonly smokers but had lower coronary anatomic burden and complexity (mean SYNTAX score 24.2 vs. 27.2, p < 0.001). By multivariate analysis, sex was not independently associated with either the primary endpoint (hazard ratio [HR]: 1.10; 95% confidence interval [CI]: 0.82 to 1.48; p = 0.53) or all-cause death (HR: 1.39; 95% CI: 0.92 to 2.10; p = 0.12) at 3 years. At 30 days, all-cause death, myocardial infarction, or stroke had occurred in 8.9% of woman treated with PCI, 6.2% of women treated with CABG, 3.6% of men treated with PCI, and 8.4% of men treated with CABG (p for interaction = 0.003). The 3-year rate of the composite primary endpoint was 19.7% in women treated with PCI, 14.6% in women treated with CABG, 13.8% in men treated with PCI, and 14.7% in men treated with CABG (p for interaction = 0.06). These differences were driven by higher periprocedural rates of myocardial infarction in women after PCI and in men after CABG.

Conclusions

In patients with unprotected left main disease in the EXCEL trial, sex was not an independent predictor of adverse outcomes after revascularization. However, women undergoing PCI had a trend toward worse outcomes, a finding related to associated comorbidities and increased periprocedural complications. Further studies are required to determine the optimal revascularization modality in women with complex coronary artery disease.





Left Main Revascularization: One Size Does Not Fit All




Long-Term Clinical Outcomes and Optimal Stent Strategy in Left Main Coronary Bifurcation Stenting
AbstractObjectives

This study sought to investigate the long-term clinical effects of stent generation and stent strategy for left main coronary artery (LMCA) bifurcation lesion treatment.

Background

Limited data are available to assess long-term clinical outcomes after stenting, including use of current-generation drug-eluting stent (C-DES) for treatment of LMCA bifurcation lesions.

Methods

A total of 1,353 patients who were recorded in 2 multicenter real-world registries were treated by either early-generation drug-eluting stent (E-DES) (n = 889) or C-DES (n = 464). Primary endpoint was major adverse cardiovascular events (MACE). MACE was defined as a composite of cardiac death or myocardial infarction, stent thrombosis, and target lesion revascularization rates during 3-year follow-up. The authors further performed propensity-score adjustment for clinical outcomes.

Results

During 3-year follow-up, the overall MACE rate was 8.7%. Use of a 1-stent strategy resulted in better clinical outcomes than use of a 2-stent strategy (4.7% vs. 18.6%, hazard ratio [HR]: 3.71; 95% confidence interval [CI]: 2.55 to 5.39; p < 0.001). Use of C-DES resulted in a lower MACE rate compared with using E-DES (4.6% vs. 10.9%, HR: 0.55; 95% CI: 0.34 to 0.89; p = 0.014), especially for the 2-stent strategy. For patients with C-DES, the presence of chronic kidney disease and pre-intervention side branch diameter stenosis ≥50% were significant independent predictors of MACE.

Conclusions

Intervention of LMCA bifurcation lesions using DES implantation demonstrated acceptable long-term clinical outcomes, especially in C-DES patients. Use of a 1-stent strategy resulted in better clinical benefits than using a 2-stent strategy.





Left Main Bifurcation Angioplasty: Are 2 Stents One Too Many?




Debris Heterogeneity Across Different Valve Types Captured by a Cerebral Protection System During Transcatheter Aortic Valve Replacement
AbstractObjectives

This study investigated differences between transcatheter heart valve (THV) types and regarding debris captured by a cerebral embolic protection system (Claret Medical Sentinel, Santa Rosa, California).

Background

Differences of THV types and cerebral injury after transcatheter aortic valve replacement (TAVR) are not well understood.

Methods

A total of 246 patients pooled from 2 prospective studies (SENTINEL [Cerebral Protection in Transcatheter Aortic Valve Replacement] trial, N = 100; SENTINEL-H [Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement] trial, N = 146) were included in the analysis. Histopathologic assessment and histomorphometric analyses of debris were compared with THV types. Analyses were differentiated by particle size (≥150, ≥500, and ≥1,000 μm), particle count, total particle area, and maximum of largest dimension. Only commercially available THVs were included: 16% Evolut R (EvR), 15% Lotus, 59% SAPIEN 3 (S3), and 10% SAPIEN XT (XT).

Results

Particles were captured in 99% of patients. There was a significantly higher amount of debris related to the vascular bed (valve tissue, arterial wall, calcification) in EvR patients compared with S3 patients; 53% of all patients irrespective of valve type had at least 1 particle ≥1 mm. Larger particles (≥500 and ≥1,000 μm) were significantly more frequent in EvR than XT and S3 patients. Lotus patients with particles ≥1,000 μm were significantly more frequent than in S3 patients. Particle count, total particle area, and maximum of largest dimension were significantly higher in both Lotus and EvR patients compared with S3 and XT.

Conclusions

Debris was captured in 99% of patients, of whom 53% had at least 1 particle of debris >1 mm. The number and size of particles captured during a procedure in which EvR or Lotus THV was used were higher and larger than with a Sapien THV. Regardless, embolic debris, including large particles, is universal across valve types and provides mechanistic support for the potential benefit of using cerebral embolic protection in all TAVR procedures.





Embolic Protection Devices in Transcatheter Aortic Valve Replacement: Measuring Treasure or Treasuring Measure?




Platelet Reactivity and Risk of Ischemic Stroke After Coronary Drug-Eluting Stent Implantation: From the ADAPT-DES Study
AbstractObjectives

The authors sought to investigate the association between P2Y12 reaction units (PRU) and the risk of ischemic stroke (IS) after successful coronary drug-eluting stents (DES) implantation.

Background

The association between platelet reactivity on clopidogrel and the risk for ischemic cerebrovascular events remains unclear.

Methods

Incidence, predictors, and prognostic impact of IS were evaluated among patients enrolled in the multicenter, prospective ADAPT-DES (Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents) study. By protocol, patients were maintained on aspirin for 2 years and clopidogrel for at least 1 year. Baseline platelet reactivity on clopidogrel and aspirin were assessed by means of VerifyNow point-of-care assay after successful DES implantation.

Results

Among 8,582 patients enrolled, 68 (0.8%) had an IS during 2-year follow-up. Across the spectrum of PRU, rates of IS were progressively greater as patients transitioned from the lowest quintile of PRU (more P2Y12 receptor inhibition; 2-year rate of 0.51%) to the highest quintile of PRU (less P2Y12 receptor inhibition; 2-year rate of 1.34%; adjusted p = 0.04). PRU >208 was independently associated with higher risk of IS at 2 years (adjusted hazard ratio 1.81; 95% confidence interval 1.08 to 3.04; p = 0.03). The association between higher PRU and risk for IS was also consistent in patients with versus without high CHA2DS2-VASc score (pinteraction = 0.30) and in those on or off oral anticoagulation at discharge (pinteraction = 0.99). Occurrence of IS was strongly associated with increased risk of all-cause mortality at 2 years (adjusted HR: 4.16; 95% CI: 1.95 to 8.87; p < 0.0001).

Conclusions

Higher PRU was associated with increased risk of IS after coronary DES implantation. Ensuring adequate platelet P2Y12 receptor inhibition may reduce the risk of IS in this patient population. (Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents [ADAPT-DES]; NCT00638794)





Never So Simple: Bedside Measurement of Platelet Reactivity and the Risk of Stroke After Coronary Stenting




Carotid Stenting With Antithrombotic Agents and Intracranial Thrombectomy Leads to the Highest Recanalization Rate in Patients With Acute Stroke With Tandem Lesions
AbstractObjectives

The aim of this study was to identify the optimal endovascular approach in patients with acute stroke with tandem lesions.

Background

At present, there is no consensus about the ideal technical strategy for the endovascular treatment of patients with acute ischemic stroke with tandem lesions of the extracranial internal carotid artery (ICA) and intracranial cerebral arteries.

Methods

This was an international, multicenter registry with a total of 482 patients with acute ischemic stroke and tandem lesions. Patients were treated by intracranial thrombectomy as well as 1 of the following 4 strategies: 1) acute carotid artery stenting of the extracranial ICA with antithrombotic agents; 2) acute carotid artery stenting of the extracranial ICA without antithrombotic agents; 3) balloon angioplasty of the extracranial ICA; and 4) intracranial thrombectomy alone. The main outcome endpoints of the study were the degree of recanalization and the 90-day clinical outcome. The safety endpoints were symptomatic intracerebral hemorrhage and all causes of mortality at 90 days.

Results

Using univariate analysis, the rates of successful reperfusion (modified Thrombolysis in Cerebral Infarction grades 2B and 3) and favorable clinical outcome after 90 days were significantly higher after acute carotid stenting with antithrombotic therapy and thrombectomy compared with the group with thrombectomy alone. After adjusting for confounding variables, acute stenting with antithrombotic therapy was independently associated with successful recanalization (odds ratio: 2.4; 95% confidence interval: 1.25 to 4.59; p = 0.008). The rates of symptomatic intracerebral hemorrhage and 90-day mortality were comparable among all 4 treatment groups.

Conclusions

Acute stenting of the extracranial ICA with antithrombotic therapy in combination with intracranial thrombectomy is associated with higher recanalization rates in treatment of patients with acute stroke with tandem lesions.





Commentary on Optimal Treatment Strategy for Tandem Stroke




Single Transseptal Puncture for Left Atrial Appendage Closure and Mitral Valvuloplasty With Total Cerebrovascular Protection in a Patient With Acute Embolic Cerebral Ischemia




Percutaneous Retrieval of an Air Bullet From the Left Ventricle




The IMPACTOR-CTO Trial




Procedural Success and Clinical Outcome of the Portico Transcatheter Aortic Valve Using the Left Subclavian Artery as Primary Access




Percutaneous Edge-to-Edge Mitral Valve Repair Using the New MitraClip XTR System




Transcatheter Mitral Annuloplasty in Barlows Mitral Regurgitation With Deep Cleft




Endovascular Management of Acute Aortic Dissection in Takayasu Arteritis




Predictors of Procedural and Clinical Outcomes in Patients With Symptomatic Tricuspid Regurgitation Undergoing Transcatheter Edge-to-Edge Repair
AbstractObjectives

This study sought to investigate predictors of procedural success and clinical outcomes in patients with tricuspid regurgitation (TR) at increased surgical risk undergoing transcatheter tricuspid valve edge-to-edge repair (TTVR).

Background

Recent data suggest TTVR using the edge-to-edge repair technique in patients at high surgical risk is feasible and improves functional status at short-term follow-up.

Methods

TTVR was carried out in 117 patients with symptomatic TR (median age 79.0 years [interquartile range (IQR): 75.5 to 83.0 years], EuroSCORE II 6.3% [IQR: 4.1% to 10.8%], STS mortality score 5.3% [IQR: 2.9% to 7.1%]) at 2 centers in Germany between March 2016 and November 2017. Seventy-four patients had concomitant severe mitral regurgitation and underwent transcatheter edge-to-edge repair of both valves.

Results

During TTVR, 185 and 34 clips were implanted at the anteroseptal and posteroseptal commissures, respectively. Procedural success (TR reduction ≥1) was achieved in 81% of patients. Median TR effective regurgitant orifice area was reduced from 0.5 to 0.2 cm2. After a median follow-up of 184 days (IQR: 106 to 363 days), 24 patients died and 21 patients were readmitted for heart failure. TTVR procedural success independently predicted the time free of death and admission for heart failure (hazard ratio: 0.20 [95% confidence interval: 0.08 to 0.48]; p < 0.01), irrespective of concomitant mitral regurgitation. Small TR coaptation gap size and a central/anteroseptal TR jet location independently predicted procedural success on multivariate analysis.

Conclusions

Successful TR reduction by TTVR serves as a predictor for reduced mortality and heart failure hospitalization. TR coaptation gap and jet location may assist in decision making whether a patient is anatomically suited for TTVR.





Tricuspid Valve Regurgitation: A Challenge for Interventional Treatment




Comparison of Clinical and Echocardiographic Outcomes After Surgical Redo Mitral Valve Replacement and Transcatheter Mitral Valve-in-Valve Therapy
AbstractObjectives

There are minimal data regarding clinical outcomes and echocardiographic findings after transcatheter mitral valve-in-valve replacement (TMVR) compared with redo surgical mitral valve replacement (SMVR).

Background

TMVR therapy has emerged as therapy for a degenerated bioprosthetic valve failure.

Methods

The authors retrospectively identified patients with degenerated mitral bioprostheses who underwent redo SMVR or TMVR at 3 U.S. institutions. The authors compared clinical and echocardiographic outcomes of patients who had TMVR with those of patients who underwent redo SMVR.

Results

Sixty-two patients underwent TMVR and 59 patients underwent SMVR during the study period. Mean age and the Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) scores were significantly higher in patients with TMVR than in those with SMVR (age 74.9 ± 9.4 years vs. 63.7 ± 14.9 years; p < 0.001; STS PROM 12.7 ± 8.0% vs. 8.7 ± 10.1%; p < 0.0001). Total procedure time, intensive care unit hours, and post-procedure length of stay were all significantly shorter in the TMVR group. There was no difference in mortality at 1 year between the 2 groups (TMVR 11.3% vs. SMVR 11.9%; p = 0.92). Mean mitral valve pressure gradient and the grade of mitral regurgitation (MR) were similar between the TMVR group and the SMVR group (mitral valve pressure gradient 7.1 ± 2.5 mm Hg vs. 6.5 ± 2.5 mm Hg; p = 0.42; MR [≥moderate] 3.8% vs. 5.6%; p = 1.00) at 30 days. At 1 year, the mitral valve pressure gradient was higher in the TMVR group (TMVR 7.2 ± 2.7 vs. SMVR 5.5 ± 1.8; p = 0.01), although there was no difference in the grade of MR.

Conclusions

Despite the higher STS PROM in TMVR patients, there was no difference in 1-year mortality between the TMVR and SMVR groups. Echocardiographic findings after TMVR were similar to SMVR at 30 days. There was a statistically significant difference in mitral gradient at 1 year, though this is likely not clinically important. TMVR may be an alternative to SMVR in patients with previous mitral bioprosthetic valves.





Transcatheter Mitral Valve-in-Valve Replacement: The New Gold Standard for Treating Mitral Bioprosthesis Failure?




Combined Mitral and Tricuspid Versus Isolated Mitral Valve Transcatheter Edge-to-Edge Repair in Patients With Symptomatic Valve Regurgitation at High Surgical Risk
AbstractObjectives

The present study aimed to test the clinical benefit of combined transcatheter mitral plus tricuspid valve edge-to-edge repair (TMTVR) as compared with transcatheter mitral valve edge-to-edge repair (TMVR) alone in patients with both significant mitral (MR) and tricuspid regurgitation (TR) at high surgical risk.

Background

A growing number of patients with severe MR at increased surgical risk are treated by transcatheter techniques. Evidence suggests that residual TR remains a predictor of adverse outcome in these patients.

Methods

Sixty-one patients (mean age 79.5 ± 8.4 years, EuroSCORE II 8.6 ± 5.9%) underwent TMTVR (n = 27) or TMVR (n = 34). Echocardiographic and cardiac magnetic resonance imaging was performed before and after the procedure.

Results

Reduction of MR was similar in patients undergoing TMTVR and TMVR. Effective regurgitant orifice area of TR was reduced from 0.51 to 0.29 cm2 in patients with TMTVR (p < 0.01), but remained unchanged after TMVR. On cardiac magnetic resonance imaging, only patients in the TMTVR group exhibited improved effective right and left ventricular stroke volume, and increased cardiac index (2.1 vs. 2.5 l/min/m2; p < 0.01). TMTVR led to superior improvement in New York Heart Association functional class, NT-proBNP levels, and 6-min walking distance as compared with TMVR. After up to 18 months of follow-up, patients with TMTVR experienced fewer hospitalizations for heart failure when compared with patients with TMVR (p = 0.02), whereas rates of death were comparable between both groups of patients.

Conclusions

TMTVR appears superior to TMVR in terms of cardiac output and functional improvement early after the intervention, and improves clinical outcome up to 18 months of follow-up.





Mitral Meets Tricuspid: Is Severe Tricuspid Regurgitation a Bystander or Is There a Need for Combined Percutaneous Mitral and Tricuspid Valve Repair?




Implications of Concomitant Tricuspid Regurgitation in Patients Undergoing Transcatheter Aortic Valve Replacement for Degenerated Surgical Aortic Bioprosthesis: Insights From the PARTNER 2 Aortic Valve-in-Valve Registry
AbstractObjectives

The aim of this study was to assess the implications of concomitant tricuspid regurgitation (TR) in patients undergoing valve-in-valve (VIV) transcatheter aortic valve replacement.

Background

Patients undergoing VIV transcatheter aortic valve replacement with concomitant TR may have worse outcomes, and optimal management remains undetermined.

Methods

The multicenter PARTNER 2 (Placement of Aortic Transcatheter Valves) VIV trial enrolled patients with symptomatic degenerated surgical aortic bioprostheses who were at high risk for reoperation. Outcomes were assessed between patients with mild or no TR versus moderate or severe TR.

Results

A total of 237 patients underwent VIV procedures (mean age 78.7 ± 10.8 years, mean Society of Thoracic Surgeons score 9.1 ± 4.8%). In this cohort, 162 patients (68.4%) had mild or no TR, and 75 patients (31.6%) had moderate or severe TR. Although there was no difference in New York Heart Association functional class III or IV symptomatic status (89.3% vs. 91.4%; p = 0.62) or moderate or severe right ventricular dysfunction (9.4% vs. 16.9%; p = 0.11), patients with moderate or severe TR were more likely to be at high surgical risk, with a Society of Thoracic Surgeons score of >8 (62.7% vs 46.9%; p = 0.02). There was no difference in a composite endpoint of death and rehospitalization between moderate or severe TR and mild or no TR, either at 30 days (10.7% vs. 9.9%; p = 0.85) or at 1-year follow-up (24.1% vs. 23.2%; p = 0.80). There was a significant reduction in overall moderate or severe TR from baseline at 30 days (31.1% vs. 21.1%; p = 0.002), which was sustained at 1-year follow-up (38.0% vs. 22.8%; p = 0.004).

Conclusions

Despite higher predicted surgical risk, the presence of TR was not a predictor of long-term outcomes. Importantly, there was significant reduction in TR severity at both short- and long-term follow-up. In selected patients undergoing VIV transcatheter aortic valve replacement, it may be appropriate to conservatively manage concomitant TR.





Exploring Tricuspid Regurgitation in Treating Degenerated Bioprosthetic Aortic Valves




Medium-Term Follow-Up of Early Leaflet Thrombosis After Transcatheter Aortic Valve Replacement
AbstractObjectives

The aim of this study was to investigate medium-term outcomes in patients with leaflet thrombosis (LT).

Background

The clinical significance of early LT after transcatheter aortic valve replacement, diagnosed by computed tomography angiography in approximately 10% of patients, is uncertain.

Methods

In this observational study, computed tomographic angiography was performed a median of 5 days after transcatheter aortic valve replacement and assessed for evidence of LT. Follow-up consisted of clinical visits, telephone contact, or questionnaire.

Results

LT was diagnosed in 120 of 754 patients (15.9%). Patients with LT were less likely male (36.7% vs. 47.0%, p = 0.045), with a lower rate of atrial fibrillation (28.3% vs. 41.5%, p = 0.008). Peri- and post-procedural characteristics were comparable between groups (e.g., valve implantation technique; p = 0.116). During a median follow-up period of 406 days, there were no significant differences in the primary endpoint of all-cause mortality and the secondary combined endpoint of stroke and transient ischemic attack between patients with LT and those without LT (18-month Kaplan-Meier estimate for mortality 86.6% vs. 85.4%, p = 0.912; for stroke- or transient ischemic attack–free survival 98.5% vs. 96.8%, p = 0.331). In univariate and multivariate analyses, LT was not predictive of either endpoint, whereas male sex (p = 0.03), atrial fibrillation (p = 0.002), and more than mild paravalvular leak (p = 0.015) were associated with all-cause mortality.

Conclusions

In this prospective observational cohort undergoing post–transcatheter aortic valve replacement computed tomographic angiography, LT was not associated with increased mortality or rates of stroke over a follow-up period of 406 days.





Early Leaflet Thrombosis: Is it Benign?




Outcomes Following Urgent/Emergent Transcatheter Aortic Valve Replacement: Insights From the STS/ACC TVT Registry
AbstractObjectives

The authors sought to examine outcomes and identify independent predictors of mortality among patients undergoing urgent/emergent transcatheter aortic valve replacement (TAVR).

Background

Data on urgent/emergent TAVR as a rescue therapy for decompensated severe aortic stenosis (AS) are limited.

Methods

The Society of Thoracic Surgeons and the American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry linked with Centers for Medicare & Medicaid Services claims was used to identify patients who underwent urgent/emergent versus elective TAVR between November 2011 and June 2016. Outcomes assessed were device success rate, in-hospital major adverse events, and 30-day and 1-year mortality. Independent predictors of mortality after urgent/emergent TAVR were examined.

Results

Of 40,042 patients who underwent TAVR, 3,952 (9.9%) were urgent/emergent (median STS PROM score 11.8 [interquartile range: 7.6 to 17.9]). Device success rate was statistically lower, but not clinically different after urgent/emergent versus elective TAVR (92.6% vs. 93.7%; p = 0.007). Rates of major and/or life-threatening bleeding, major vascular complications, myocardial infarction, stroke, new permanent pacemaker placement, conversion to SAVR, and paravalvular regurgitation were similar between the 2 groups. Compared with elective TAVR, patients undergoing urgent/emergent TAVR had higher rates of acute kidney injury and/or new dialysis (8.2% vs. 4.2%; p < 0.001), 30-day mortality (8.7% vs. 4.3%, adjusted hazard ratio: 1.28, 95% confidence interval: 1.10 to 1.48), and 1-year mortality (29.1% vs. 17.5%, adjusted hazard ratio: 1.20, 95% confidence interval: 1.10 to 1.31). In patients undergoing urgent/emergent TAVR, non-femoral access and cardiopulmonary bypass were associated with increased risk, whereas use of balloon-expandable valve was associated with decreased risk of 30-day and 1-year mortality.

Conclusions

Urgent/emergent TAVR is feasible with acceptable outcomes and may be a reasonable option in a selected group of patients with severe AS.





Whose Urgency Is it, Anyway?




Effect of SAPIEN 3 Transcatheter Valve Implantation on Health Status in Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: Results From the PARTNER S3i Trial
AbstractObjectives

The aim of this study was to evaluate whether transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve (S3-TAVR) results in improved quality of life (QoL) compared with previous-generation TAVR devices or surgical aortic valve replacement (SAVR).

Background

In patients with severe aortic stenosis at intermediate surgical risk, TAVR using the SAPIEN XT valve (XT-TAVR) results in similar QoL compared with SAVR. Compared with SAPIEN XT, the SAPIEN 3 valve offers a lower delivery profile and modifications to reduce paravalvular regurgitation.

Methods

Between February and December 2014, 1,078 patients at intermediate surgical risk with severe aortic stenosis were treated with S3-TAVR in the PARTNER S3i (Placement of Aortic Transcatheter Valve) trial. QoL was assessed at baseline, 1 month, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short Form-36, and EQ-5D. QoL outcomes of S3-TAVR patients were compared with those in the SAVR and XT-TAVR arms of the PARTNER 2A trial using propensity score stratification to adjust for differences between the treatment groups.

Results

Over 1 year, S3-TAVR was associated with substantial improvements in QoL compared with baseline. At 1 month, S3-TAVR was associated with better QoL than either SAVR or XT-TAVR (adjusted differences in Kansas City Cardiomyopathy Questionnaire overall summary score 15.6 and 3.7 points, respectively; p < 0.001). At 1 year, the differences in QoL between S3-TAVR and both SAVR and XT-TAVR were reduced but remained statistically significant (adjusted differences 2.0 and 2.2 points, respectively; p < 0.05). Similar results were seen for generic QoL outcomes.

Conclusions

Among patients at intermediate surgical risk with severe aortic stenosis, S3-TAVR resulted in improved QoL at both 1 month and 1 year compared with both XT-TAVR and SAVR.





Does the Transcatheter Aortic Valve Replacement Prosthesis Type Really Have an Influence on Quality of Life?




Catching a "MitraFly"




In Vivo Stent Frame Infolding of a Self-Expanding Transcatheter Aortic Valve After Resheathing




Bedside Modification of Delivery System for Transcatheter Transseptal Mitral Replacement With POULEZ System and SAPIEN-3 Valve




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