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National Trends and Outcomes in Isolated Tricuspid Valve Surgery
AbstractBackground

Severe isolated disease of the tricuspid valve (TV) is increasing and results in intractable right heart failure. However, isolated TV surgery is rarely performed, and there are little data describing surgical outcomes.

Objectives

The purpose of this study was to evaluate contemporary utilization trends and in-hospital outcomes for isolated TV surgery in the United States.

Methods

Patients age >18 years who underwent TV repair or replacement from 2004 to 2013 were identified using the National Inpatient Sample. Patients with congenital heart disease, with endocarditis, and undergoing concomitant cardiac operations except for coronary bypass surgery were excluded.

Results

Over a 10-year period, a total of 5,005 isolated TV operations were performed nationally. Operations per year increased from 290 in 2004 to 780 in 2013 (p < 0.001 for trend). In-hospital mortality was 8.8% and did not vary across the study period. Adjusted in-hospital mortality for TV replacement was significantly higher than TV repair (odds ratio: 1.91; 95% confidence interval: 1.18 to 3.09; p = 0.009).

Conclusions

Isolated TV surgery is rarely performed, although utilization has increased over time. However, despite an increase in surgical volume, operative mortality has not changed. Mortality is greatest in patients undergoing valve replacement. Given the increasing prevalence of isolated TV disease in the population, research into optimal surgical timing and patient selection is critical.





Isolated Tricuspid Valve Surgery




5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials
AbstractBackground

The PROTECT AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial demonstrated that left atrial appendage closure (LAAC) with the Watchman device (Boston Scientific, St. Paul, Minnesota) was equivalent to warfarin for preventing stroke in atrial fibrillation, but had a high rate of complications. In a second randomized trial, PREVAIL (Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy), the complication rate was low. The warfarin cohort experienced an unexpectedly low ischemic stroke rate, rendering the efficacy endpoints inconclusive. However, these outcomes were based on relatively few patients followed for a relatively short time.

Objectives

The final results of the PREVAIL trial, both alone and as part of a patient-level meta-analysis with the PROTECT AF trial, are reported with patients in both trials followed for 5 years.

Methods

PREVAIL and PROTECT AF are prospective randomized clinical trials with patients randomized 2:1 to LAAC or warfarin; together, they enrolled 1,114 patients for 4,343 patient-years. Analyses are by intention-to-treat, and rates are events per 100 patient-years.

Results

For the PREVAIL trial, the first composite coprimary endpoint of stroke, systemic embolism (SE), or cardiovascular/unexplained death did not achieve noninferiority (posterior probability for noninferiority = 88.4%), whereas the second coprimary endpoint of post-procedure ischemic stroke/SE did achieve noninferiority (posterior probability for noninferiority = 97.5%); the warfarin arm maintained an unusually low ischemic stroke rate (0.73%). In the meta-analysis, the composite endpoint was similar between groups (hazard ratio [HR]: 0.820; p = 0.27), as were all-stroke/SE (HR: 0.961; p = 0.87). The ischemic stroke/SE rate was numerically higher with LAAC, but this difference did not reach statistical significance (HR: 1.71; p = 0.080). However, differences in hemorrhagic stroke, disabling/fatal stroke, cardiovascular/unexplained death, all-cause death, and post-procedure bleeding favored LAAC (HR: 0.20; p = 0.0022; HR: 0.45; p = 0.03; HR: 0.59; p = 0.027; HR: 0.73; p = 0.035; HR: 0.48; p = 0.0003, respectively).

Conclusions

These 5-year outcomes of the PREVAIL trial, combined with the 5-year outcomes of the PROTECT AF trial, demonstrate that LAAC with Watchman provides stroke prevention in nonvalvular atrial fibrillation comparable to warfarin, with additional reductions in major bleeding, particularly hemorrhagic stroke, and mortality. (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation; NCT00129545; and Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy; NCT01182441)





Long-Term Results With Left Atrial Appendage Closure: Watching the Watchman




Normal LDL-Cholesterol Levels Are Associated With Subclinical Atherosclerosis in the Absence of Risk Factors
AbstractBackground

Absence of cardiovascular risk factors (CVRFs) is traditionally considered low risk for atherosclerosis; however, individuals without CVRFs, as currently defined, still have events.

Objectives

This study sought to identify predictors of subclinical atherosclerosis in CVRF-free individuals.

Methods

Participants from the PESA (Progression of Early Subclinical Atherosclerosis) study (n = 4,184) without conventional CVRFs were evaluated (n = 1,779; 45.0 ± 4.1 years, 50.3% women). CVRF freedom was defined as no current smoking and untreated blood pressure <140/90 mm Hg, fasting glucose <126 mg/dl, total cholesterol <240 mg/dl, low-density lipoprotein cholesterol (LDL-C) <160 mg/dl, and high-density lipoprotein cholesterol ≥40 mg/dl. A subgroup with optimal CVRFs (n = 740) was also defined as having blood pressure <120/80 mm Hg, fasting glucose <100 mg/dl, glycosylated hemoglobin <5.7%, and total cholesterol <200 mg/dl. We evaluated ultrasound-detected carotid, iliofemoral, and abdominal aortic plaques; coronary artery calcification; serum biomarkers; and lifestyle. Adjusted odds ratios (with 95% confidence interval) and ordinal logistic regression models were used.

Results

Subclinical atherosclerosis (plaque or coronary artery calcification) was present in 49.7% of CVRF-free participants. Together with male sex and age, LDL-C was independently associated with atherosclerosis presence and extent, in both the CVRF-free and CVRF-optimal groups (odds ratio [x10 mg/dl]: 1.14 to 1.18; p < 0.01 for all). Atherosclerosis presence and extent was also associated in the CVRF-free group with glycosylated hemoglobin levels.

Conclusions

Many CVRF-free middle-aged individuals have atherosclerosis. LDL-C, even at levels currently considered normal, is independently associated with the presence and extent of early systemic atherosclerosis in the absence of major CVRFs. These findings support more effective LDL-C lowering for primordial prevention, even in individuals conventionally considered at optimal risk. (Progression of Early Subclinical Atherosclerosis [PESA] Study; NCT01410318)





Primary Prevention of Atherosclerosis: Time to Take a Selfie?




Surgical Versus Percutaneous Coronary Revascularization in Patients With Diabetes and Acute Coronary Syndromes
AbstractBackground

Randomized trial data support the superiority of coronary artery bypass grafting (CABG) surgery over percutaneous coronary intervention (PCI) in diabetic patients with multivessel coronary artery disease (MV-CAD). However, whether this benefit is seen in a real-world population among subjects with stable ischemic heart disease (SIHD) and acute coronary syndromes (ACS) is unknown.

Objectives

The main objective of this study was to assess the generalizability of the FREEDOM (Future REvascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multi-vessel Disease) trial in real-world practice among patients with diabetes mellitus and MV-CAD in residents of British Columbia, Canada. Additionally, the study evaluated the impact of mode of revascularization (CABG vs. PCI with drug-eluting stents) in diabetic patients with ACS and MV-CAD.

Methods

In a large population-based database from British Columbia, this study evaluated major cardiovascular outcomes in all diabetic patients who underwent coronary revascularization between 2007 and 2014 (n = 4,661, 2,947 patients with ACS). The primary endpoint (major adverse cardiac or cerebrovascular events [MACCE]) was a composite of all-cause death, nonfatal myocardial infarction, and nonfatal stroke. The risk of MACCE with CABG or PCI was compared using multivariable adjustment and a propensity score model.

Results

At 30-days post-revascularization, for ACS patients the odds ratio for MACCE favored CABG 0.49 (95% confidence interval [CI]: 0.34 to 0.71), whereas among SIHD patients MACCE was not affected by revascularization strategy (odds ratio: 1.46; 95% CI: 0.71 to 3.01; pinteraction <0.01). With a median follow-up of 3.3 years, the late (31-day to 5-year) benefit of CABG over PCI no longer varied by acuity of presentation, with a hazard ratio for MACCE in ACS patients of 0.67 (95% CI: 0.55 to 0.81) and the hazard ratio for SIHD patients of 0.55 (95% CI: 0.40 to 0.74; pinteraction = 0.28).

Conclusions

In diabetic patients with MV-CAD, CABG was associated with a lower rate of long-term MACCE relative to PCI for both ACS and SIHD. A well-powered randomized trial of CABG versus PCI in the ACS population is warranted because these patients have been largely excluded from prior trials.





Do We Need a Trial of DES Versus CABG Surgery in Diabetic Patients With ACS?




Hydroquinidine Prevents Life-Threatening Arrhythmic Events in Patients With Short QT Syndrome
AbstractBackground

Short QT syndrome (SQTS) is a rare and life-threatening arrhythmogenic syndrome characterized by abbreviated repolarization. Hydroquinidine (HQ) prolongs the QT interval in SQTS patients, although whether it reduces cardiac events is currently unknown.

Objectives

This study investigated whether long-term treatment with HQ reduces the occurrence of life-threatening arrhythmic events (LAE) (cardiac arrest or sudden cardiac death) in SQTS patients.

Methods

In this cohort study on consecutive SQTS patients, 2 analyses were performed: 1) a matched-period analysis for the occurrence of LAE in 17 SQTS patients who received long-term HQ; and 2) a comparison of the annual incidence of LAE off- and on-HQ in 16 SQTS patients who survived a cardiac arrest.

Results

A total of 17 patients (82% male, age 29 ± 3 years, QTc before treatment 331 ± 3 ms) received HQ therapy (584 ± 53 mg/day). Therapy was stopped in 2 cases (12%) due to gastrointestinal intolerance, and 15 patients continued treatment for 6 ± 1 year. QTc prolongation was observed in all patients (by 60 ± 6 ms; p < 0.001). We compared the occurrence of LAE during 6 ± 1 years before and after HQ, observing that patients on HQ experienced a reduction in both the rate of LAE from 40% to 0% (p = 0.03) and the number of LAE per patient from 0.73 ± 0.3 to 0 (p = 0.026). Furthermore, the annual rate of LAE in the 16 patients with a previous cardiac arrest dropped from 12% before HQ to 0 on therapy (p = 0.028).

Conclusions

We demonstrated for the first time that treatment with HQ was associated with a lower incidence of LAE in SQTS patients. These data point to the importance that quinidine, that in several countries has been removed from the market, remains available worldwide for patients with SQTS. In the present study, therapy with HQ has been proven to be safe, with a relatively low rate of side effects.





Short QT Syndrome and Hydroquinidine: Rare Diseases and Unavailable Drugs




Data Sharing and Cardiology: Platforms and Possibilities
Abstract

Sharing deidentified patient-level research data presents immense opportunities to all stakeholders involved in cardiology research and practice. Sharing data encourages the use of existing data for knowledge generation to improve practice, while also allowing for validation of disseminated research. In this review, we discuss key initiatives and platforms that have helped to accelerate progress toward greater sharing of data. These efforts are being prompted by government, universities, philanthropic sponsors of research, major industry players, and collaborations among some of these entities. As data sharing becomes a more common expectation, policy changes will be required to encourage and assist data generators with the process of sharing the data they create. Patients also will need access to their own data and to be empowered to share those data with researchers. Although medicine still lags behind other fields in achieving data sharing’s full potential, cardiology research has the potential to lead the way.





Mechanical Intervention for Aortic Valve Stenosis in Patients With Heart Failure and Reduced Ejection Fraction
Abstract

The risk and benefit of mechanical interventions in valvular heart disease have been primarily described among patients with normal ejection fraction. The advent of nonsurgical mechanical interventions for aortic stenosis (transcatheter aortic valve replacement) may alter the risk-benefit ratio for patients who would otherwise be at increased risk for valve surgery. This review describes the epidemiology and pathophysiology of aortic stenosis with heart failure and reduced ejection fraction and summarizes the current registry and clinical trial data applicable to this frequently encountered high-risk group. It concludes with discussion of ongoing trials, new approaches, emerging indications, and a potential clinical algorithm incorporating optimal mechanical intervention for patients with aortic stenosis and concomitant reduced ejection fraction.





2017 ACC Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants: A Report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways




Improved Survival After Implementation of a Large-Scale Regional Dedicated Aortic Network




Heart Failure and Ischemic Heart Disease in Patients With Rheumatoid Arthritis




Statistical Analyses of Arginine-Nitric Oxide Metabolites and Cardiac Dysfunction




Flow-Mediated Dilation of Brachial Artery as a Screening Tool for Anthracycline-Induced Cardiotoxicity




The Anticoagulation Conundrum of Mechanical Heart Valves in Pregnancy: Should DOACs Be Considered?




Reply: Statistical Analyses of Arginine-Nitric Oxide Metabolites and Cardiac Dysfunction




Reply: The Anticoagulation Conundrum of Mechanical Heart Valves in Pregnancy: Should DOACs Be Considered?




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JACC: Cardiovascular Interventions recent issues

JACC: Cardiovascular Interventions RSS feed -- recent issues

Intrastent Hematoma After Pre-Dilatation for 17-Month Restenosis of Polytetrafluoroethylene-Covered Stent: Insights From Intravascular Imaging




Is the Intracoronary Electrocardiogram Lesion Specific?




Treatment of End-Stage Heart Failure by Transcatheter Closure of Arteria Iliaca Communis-Venae Cava Inferior Fistula Caused by Traumatism




The State of the Absorb Bioresorbable Scaffold: Consensus From an Expert Panel
Abstract

Significant progress has been made in the percutaneous coronary intervention technique from the days of balloon angioplasty to modern-day metallic drug-eluting stents (DES). Although metallic stents solve a temporary problem of acute recoil following balloon angioplasty, they leave behind a permanent problem implicated in very late events (in addition to neoatherosclerosis). BRS were developed as a potential solution to this permanent problem, but the promise of these devices has been tempered by clinical trials showing increased risk of safety outcomes, both early and late. This is not too dissimilar to the challenges seen with first-generation DES in which refinement of deployment technique, prolongation of dual antiplatelet therapy, and technical iteration mitigated excess risk of very late stent thrombosis, making DES the treatment of choice for coronary artery disease. This white paper discusses the factors potentially implicated in the excess risks, including the scaffold consideration and deployment technique, and outlines patient and lesion selection, implantation technique, and dual antiplatelet therapy considerations to potentially mitigate this excess risk with the first-generation thick strut Absorb scaffold (Abbott Vascular, Abbott Park, Illinois). It remains to be seen whether these considerations together with technical iterations will ultimately close the gap between scaffolds and metal stents for short-term events while at the same time preserving options for future revascularization once the scaffold bioresorbs.





Bioresorbable Scaffolds: A Complex Journey to the "Promised Land"




Characteristics, Predictors, and Mechanisms of Thrombosis in Coronary Bioresorbable Scaffolds: Differences Between Early and Late Events
AbstractObjectives

The study sought to investigate the incidence, characteristics, predictors, and possible mechanisms of early and 3-year coronary scaffold thrombosis (ScT).

Background

An increased incidence of both early and late ScT has been shown in randomized trials.

Methods

Consecutive patients were enrolled in a single-center registry. Quantitative coronary angiography was performed. Incidence and predictors of ScT were assessed with Kaplan-Meier and Cox regression analyses.

Results

A total of 657 patients (63 ± 12 years of age, 79% men, 21% diabetic, 64% acute coronary syndrome) who received 925 coronary bioresorbable scaffolds (BRS) (Abbott Vascular, Santa Clara, California) between May 2012 and January 2015 were enrolled. Clinical and procedural characteristics and outcome data at 1,076 (interquartile range: 762 to 1,206) days (3-year follow-up rate 93%) were collected. Twenty-eight ScTs were recorded: 14 early (Kaplan-Meier estimate: 2.2%), 5 late (Kaplan-Meier estimate: 0.9%), and 9 very late (Kaplan-Meier estimate: 1.7%). The incidence of ScT followed a U-shaped curve with highest incidence at the extremes of the distributions of reference vessel diameter (RVD) and the ratio of BRS nominal diameter to RVD. At quantitative coronary angiography, RVD (hazard ratio [HR]: 0.14; 95% confidence interval [CI]: 0.04 to 0.49) and BRS oversizing (ratio of BRS nominal diameter to RVD >1.15; HR: 107.40; 95% CI: 9.20 to 1,261.30) emerged as potent predictors of early ScT. RVD (HR: 9.55; 95% CI: 3.90 to 23.42) and BRS undersizing (ratio of BRS nominal diameter to RVD <0.85; HR: 0.0004; 95% CI: 0.0000 to 0.0400) predicted late or very late ScT (all p < 0.0001). The incidence of both early and late or very late ScT were lower (~80% reduction) when an optimal implantation technique was used. The most important factor appeared to be vessel and BRS sizing.

Conclusions

Different mechanisms underlie early and late ScT: although incomplete BRS deployment was a predictor of the former, the latter was associated with large vessel size and BRS undersizing. However, both phenomena are significantly less frequent with an optimized implantation technique. (Mainz Intracoronary Database. The Coronary Slow-flow and Microvascular Diseases Registry [MICAT]; NCT02180178)





Early and Late Bioresorbable Vascular Scaffold Thrombosis: Size Matters




Endothelial Barrier Protein Expression in Biodegradable Polymer Sirolimus-Eluting Versus Durable Polymer Everolimus-Eluting Metallic Stents
AbstractObjectives

This study sought to investigate endothelial coverage and barrier protein expression following stent implantation.

Background

Biodegradable polymer drug-eluting stents (BP-DES) have been purported to have biological advantages in vessel healing versus durable polymer DES (DP-DES), although clinical trial data suggest equipoise.

Methods

Biodegradable polymer-sirolimus-eluting stents (BP-SES), durable polymer-everolimus-eluting stents (DP-EES), and bare-metal stents (BMS) were compared. In the rabbit model (28, 45, and 120 days), stented arteries underwent light microscopic analysis and immunostaining for the presence of vascular endothelium (VE)-cadherin, an endothelial barrier protein, and were subjected to confocal microscopy and scanning electron microscopy. A cell culture study in stented silicone tubes was performed to assess cell proliferation.

Results

Light microscopic assessments were similar between BP-SES and DP-EES. BMS showed nearly complete expression of VE-cadherin at 28 days, whereas both DES showed significantly less with results favoring BP-SES versus DP-EES (39% coverage in BP-SES, 22% in DP-EES, 95% in BMS). Endothelial cell morphologic patterns differed according to stent type with BMS showing a spindle-like shape, DP-EES a cobblestone pattern, and BP-SES a shape in between. VE-cadherin-negative areas showed greater surface monocytes regardless of type of stent. Cell proliferation was suppressed in both DES with numerically less suppression in BP-SES versus DP-EES.

Conclusions

This is the first study to examine VE-cadherin expression after DES. All DES demonstrated deficient barrier expression relative to BMS with results favoring BP-SES versus DP-EES. These findings may have important implications for the development of neoatherosclerosis in different stent types.





Functionally Incomplete Re-Endothelialization of Stents and Neoatherosclerosis




Long-Term Safety and Efficacy of Platinum Chromium Everolimus-Eluting Stents in Coronary Artery Disease: 5-Year Results From the PLATINUM Trial
AbstractObjectives

The authors sought to evaluate the final 5-year safety and effectiveness of the platinum-chromium everolimus-eluting stent (PtCr-EES) in the randomized trial, as well as in 2 single-arm substudies that evaluated PtCr-EES in small vessels (diameter <2.5 mm; n = 94) and long lesions (24 to 34 mm; n = 102).

Background

In the multicenter, randomized PLATINUM (PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions), the PtCr-EES was noninferior to the cobalt-chromium everolimus-eluting stent (CoCr-EES) at 1 year in 1,530 patients undergoing percutaneous coronary intervention.

Methods

Patients with 1 or 2 de novo coronary artery lesions (reference vessel diameter 2.50 to 4.25 mm, length ≤24 mm) were randomized 1:1 to PtCr-EES versus CoCr-EES. All patients in the substudies received PtCr-EES. The primary endpoint was target lesion failure (TLF), a composite of target vessel-related cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization.

Results

In the randomized trial, the 5-year TLF rate was 9.1% for PtCr-EES and 9.3% for CoCr-EES (hazard ratio [HR]: 0.97; p = 0.87). Landmark analysis demonstrated similar TLF rates from discharge to 1 year (HR: 1.12; p = 0.70) and from 1 to 5 years (HR: 0.90; p = 0.63). There were no significant differences in the rates of cardiac death, myocardial infarction, target lesion or vessel revascularization, or stent thrombosis. PtCr-EES had 5-year TLF rates of 7.0% in small vessels and 13.6% in long lesions.

Conclusions

PtCr-EES demonstrated comparable safety and effectiveness to CoCr-EES through 5 years of follow-up, with low rates of stent thrombosis and other adverse events. The 5-year event rates were also acceptable in patients with small vessels and long lesions treated with PtCr-EES. (The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions [PLATINUM]; NCT00823212; The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions in Small Vessels [PLATINUM SV]; NCT01498692; The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of Long De Novo Coronary Artery Lesions [PLATINUM LL]; NCT01500434)





The DELTA 2 Registry: A Multicenter Registry Evaluating Percutaneous Coronary Intervention With New-Generation Drug-Eluting Stents in Patients With Obstructive Left Main Coronary Artery Disease
AbstractObjectives

The aim of this study was to evaluate clinical outcomes of unprotected left main coronary artery percutaneous coronary intervention (PCI) with new-generation drug-eluting stents in a "real world" population.

Background

PCI of the unprotected left main coronary artery is currently recommended as an alternative to coronary artery bypass grafting (CABG) in selected patients.

Methods

All consecutive patients with unprotected left main coronary artery stenosis treated by PCI with second-generation drug-eluting stents were analyzed in this international, all-comers, multicenter registry. The results were compared with those from the historical DELTA 1 (Drug Eluting Stent for Left Main Coronary Artery) CABG cohort using propensity score stratification. The primary endpoint was the composite of death, myocardial infarction (MI), or stroke at the median time of follow-up.

Results

A total of 3,986 patients were included. The mean age was 69.6 ± 10.9 years, diabetes was present in 30.8%, and 21% of the patients presented with acute MI. The distal left main coronary artery was involved in 84.6% of the lesions. At a median of 501 days (17 months) of follow-up, the occurrence of the primary endpoint of death, MI, or cerebrovascular accident was lower in the PCI DELTA 2 group compared with the historical DELTA 1 CABG cohort (10.3% vs. 11.6%; adjusted hazard ratio: 0.73; 95% confidence interval: 0.55 to 0.98; p = 0.03). Of note, an advantage of PCI was observed with respect to cerebrovascular accident (0.8% vs. 2.0%; adjusted hazard ratio: 0.37; 95% confidence interval: 0.16 to 0.86; p = 0.02), while an advantage of CABG was observed with respect to target vessel revascularization (14.2% vs. 2.9%; adjusted hazard ratio: 3.32; 95% confidence interval: 2.12 to 5.18; p < 0.0001).

Conclusions

After a median follow-up period of 17 months, PCI with new-generation drug-eluting stents was associated with an overall low rate of the composite endpoint of death, MI, or cerebrovascular accident.





Left Main Disease: At the Intersection of Surgery and Stents




Transapical Transcatheter Aortic Valve Replacement Is Associated With Increased Cardiac Mortality in Patients With Left Ventricular Dysfunction: Insights From the PARTNER I Trial
AbstractObjectives

The authors sought to evaluate the impact of transapical (TA) transcatheter aortic valve replacement (TAVR) on mortality, left ventricular (LV) ejection fraction (LVEF) improvement, and functional recovery in patients with LV dysfunction.

Background

LV injury inherent to TA access for structural heart disease interventions may be particularly detrimental to the LV, functional recovery, and survival in patients with LV dysfunction.

Methods

The study included patients enrolled within the PARTNER I (Placement of Aortic Transcatheter Valves) trial that underwent transfemoral (TF) or TA TAVR. Analyses of clinical outcomes were stratified by the presence of baseline LV dysfunction (LVEF<50%) and adjusted for the propensity of receiving TA TAVR.

Results

Of 2,084 subjects, 1,057 underwent TA TAVR. TA access was associated with increased 2-year all-cause mortality in those with (adjusted hazard ratio [HRadjusted]: 1.52; 95% confidence interval [CI]: 1.12 to 2.07; p = 0.008) and without (HRadjusted: 1.38; 95% CI: 1.10 to 1.74; p = 0.006) LV dysfunction. TA TAVR portended increased 2-year cardiac mortality in subjects with LVEF<50% (HRadjusted: 1.92; 95% CI: 1.21 to 3.05; p = 0.006), but not with LVEF≥50% (HRadjusted: 1.29; 95% CI: 0.87 to 1.90; p = 0.21). In those with LVEF<50%, greater improvements in LVEF (TF–TA difference +4.04%, 95% CI: 2.39% to 5.69%; p < 0.0001) and 6-min walk distance (TF–TA difference +45.1 m, 95% CI: 18.4 to 71.9 m; p = 0.001) occurred within 30 days after TF versus TA TAVR.

Conclusions

Compared with TF TAVR, TA TAVR is associated with a disproportionate risk of cardiac mortality in patients with LV dysfunction and with delayed and less robust improvement in LV function and overall functional status. Caution is warranted when considering TA access for structural heart disease interventions, particularly in patients with LV dysfunction. (Placement of Aortic Transcatheter Valves [PARTNER]; NCT00530894)





Transapical Approach: Learn From the Past, Move Toward the Future




Incidence, Prognostic Impact, and Predictive Factors of Readmission for Heart Failure After Transcatheter Aortic Valve Replacement
AbstractObjectives

The aim of this study was to assess the incidence, prognostic impact, and predictive factors of readmission for congestive heart failure (CHF) in patients with severe aortic stenosis treated by transcatheter aortic valve replacement (TAVR).

Background

TAVR is indicated in patients with severe symptomatic aortic stenosis in whom surgery is considered high risk or is contraindicated. Readmission for CHF after TAVR remains a challenge, and data on prognostic and predictive factors are lacking.

Methods

All patients who underwent TAVR from January 2010 to December 2014 were included. Follow-up was achieved for at least 1 year and included clinical and echocardiographic data. Readmission for CHF was analyzed retrospectively.

Results

This study included 546 patients, 534 (97.8%) of whom were implanted with balloon-expandable valves preferentially via the transfemoral approach in 87.8% of cases. After 1 year, 285 patients (52.2%) had been readmitted at least once, 132 (24.1%) for CHF. Patients readmitted for CHF had an increased risk for death (p < 0.0001) and cardiac death (p < 0.0001) compared with those not readmitted for CHF. On multivariate analysis, aortic mean gradient (hazard ratio [HR]: 0.88; 95% confidence interval [CI]: 0.79 to 0.99; p = 0.03), post-procedural blood transfusion (HR: 2.27; 95% CI: 1.13 to 5.56; p = 0.009), severe post-procedural pulmonary hypertension (HR: 1.04; 95% CI: 1.00 to 1.07; p < 0.0001), and left atrial diameter (HR: 1.47; 95% CI: 1.08 to 2.01; p = 0.02) were independently associated with CHF readmission at 1 year.

Conclusions

Readmission for CHF after TAVR was frequent and was strongly associated with 1-year mortality. Low gradient, persistent pulmonary hypertension, left atrial dilatation, and transfusions were predictive of readmission for CHF.





The Transcatheter Aortic Valve Replacement Bounce-Back: Does it Matter? What Can Be Done?




Endovascular Versus Surgical Revascularization for Chronic Mesenteric Ischemia: Insights From the National Inpatient Sample Database
AbstractObjectives

This study sought to compare in-hospital major adverse cardiac and cerebrovascular events (MACCE) following endovascular therapy with open surgery for chronic mesenteric ischemia (CMI).

Background

There are limited contemporary data on in-hospital cardiovascular outcomes among patients with CMI undergoing revascularization via endovascular therapy versus open surgery in the United States.

Methods

Patients with CMI undergoing endovascular or surgical (mesenteric bypass or endarterectomy) revascularization between 2007 and 2014 were identified from the National Inpatient Sample. Weighted national estimates were obtained. Primary and secondary endpoints were MACCE (death, myocardial infarction, stroke, cardiac post-operative complications) and composite in-hospital complications (MACCE + post-operative peripheral vascular complications, gastrointestinal hemorrhage, major bleeding, and bowel resection), respectively. Propensity score matching was used to obtain a balanced cohort of 880 unweighted patients in each group.

Results

Of 4,150 patients with CMI, 3,206 (77.2%) underwent endovascular therapy and 944 (22.8%) underwent surgery (weighted national estimates of 15,850 and 4,687, respectively). In the propensity-matched cohort, MACCE and composite in-hospital complications occurred significantly less often after endovascular therapy than surgery (8.6% vs. 15.9%; p < 0.001; and 15.3% vs. 20.3%; p < 0.006). Endovascular therapy was also associated with lower median hospital costs ($20,807.00 [interquartile range: $13,640.20 to $32.754.50] vs. $31,137.00 [interquartile range: $21,680.40 to $52,152.20]; p < 0.001, respectively) and shorter length of stay (5 [interquartile range: 2 to 10] vs. 10 [interquartile range: 7 to 17] days, respectively; p < 0.001) compared with open surgery.

Conclusions

In a large, retrospective analysis of patients with CMI, endovascular therapy remained the dominant revascularization modality, and was associated with lower rates of MACCE, composite in-hospital complications, lower costs, and shorter length of stay compared with surgery.





Endovascular-First Approach for Chronic Mesenteric Ischemia: The Critical Need for Reporting Standards and High-Grade Evidence




Hemodynamic Assessment Before and After Endovascular Therapy for Critical Limb Ischemia and Association With Clinical Outcomes
AbstractObjectives

This study sought to determine the relationship between change in ankle-brachial index (ABI) and toe-brachial index (TBI) and outcomes following revascularization of critical limb ischemia (CLI).

Background

An increase in ABI of 0.15 after revascularization for peripheral artery disease with claudication is considered significant. However, the utility of using change in ABI or TBI to predict outcomes in patients with CLI is unproven.

Methods

This was an observational study of 218 patients with Rutherford class V or VI CLI that underwent endovascular therapy. Receiver-operating characteristic curve analysis determined cutpoints in post-procedure ABI and TBI, as well as change in these values for endpoints of wound healing, major adverse limb events (MALE), and repeat revascularization.

Results

After multivariable Cox proportional hazards analysis adjusting for age, diabetes, glomerular filtration rate, smoking, Rutherford class, and baseline ABI or TBI, neither static post-procedure ABI nor post-procedure TBI were associated with wound healing (hazard ratio [HR]: 1.21; 95% confidence interval [CI]: 0.77 to 1.89; p = 0.40; HR: 1.49; 95% CI: 0.98 to 2.27; p = 0.065, respectively). However, change in ABI ≥0.23 was independently associated with wound healing (HR: 1.87; 95% CI: 1.12 to 3.15; p = 0.018) and less repeat revascularization (HR: 0.40; 95% CI: 0.19 to 0.84; p = 0.015), but not MALE. Increase in TBI ≥0.21 was independently associated with wound healing (HR: 1.63; 95% CI: 1.02 to 2.59; p = 0.039), and reduced MALE (HR: 0.27; 95% CI: 0.09 to 0.77; p = 0.014), but not repeat revascularization.

Conclusions

A change in ABI and TBI from pre-procedural values provides prognostic value in determining which patients may have wound healing and reduced MALE.





Hemodynamic Threshold for Wound Healing in Critical Limb Ischemia




Asymptomatic Large Thrombus Formation in Drug-Eluting Stent 2 Days After Primary Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction Patient




Percutaneous Interventional Repair of an Intraoperative Right Coronary Artery Tear




Parasympathetic Stimulation in Acute Myocardial Infarction: Is There a Role for a Pharmacologic Alternative Beyond Vagal Electrical Stimulation?




Reply: Parasympathetic Stimulation in Acute Myocardial Infarction: Is There a Role for a Pharmacologic Alternative Beyond Vagal Electrical Stimulation?




Cangrelor or Abciximab as First Choice in Cardiogenic Shock




Reply: Cangrelor or Abciximab as First Choice in Cardiogenic Shock




Early Risk Stratification in Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction Treated With Extracorporeal Life Support and Primary Percutaneous Coronary Intervention




Successful Percutaneous Transcatheter Angioplasty of Radial Artery in Thromboangiitis Obliterans (Buergers Disease)




Variant Angina Leading to Cardiac Arrest in a Patient With Moyamoya Disease




Usefulness of the Jailed-Balloon Technique in Percutaneous Intervention for Severe Coronary Perforation Involving Left Main Bifurcation




Contemporary Arterial Access in the Cardiac Catheterization Laboratory
Abstract

Obtaining femoral and radial arterial access in the cardiac catheterization laboratory using state-of-the-art techniques is essential to optimize outcomes, patient satisfaction, and procedural efficiency. Although transradial access is increasingly used for coronary angiography and percutaneous coronary intervention, femoral access remains necessary for numerous procedures, many requiring large-bore access, including complex high-risk coronary interventions, structural procedures, and procedures involving mechanical circulatory support. For femoral access, contemporary access techniques should combine the use of fluoroscopy, ultrasound, micropuncture needle, femoral angiography, and vascular closure devices, when feasible. For radial access, ultrasound may reveal important anatomic features and expedite access. Despite randomized controlled trials supporting use of routine ultrasound guidance for femoral and/or radial arterial access, ultrasound remains underused in cardiac catheterization laboratories. This article reviews contemporary techniques to achieve optimal arterial access in the cardiac catheterization laboratory.





Variation in the Adoption of Transradial Access for ST-Segment Elevation Myocardial Infarction: Insights From the NCDR CathPCI Registry
AbstractObjectives

The study sought to define patient, operator, and institutional factors associated with transradial access (TRA) in ST-segment elevation myocardial infarction (STEMI) percutaneous coronary intervention (PCI), the variation in use across operators and institutions, and the relationship with mortality and bleeding.

Background

TRA for PCI in STEMI is underutilized. Factors associated with TRA are not well described, nor is there variation across operators and institutions or their relationship with outcomes.

Methods

The authors used hierarchical logistic regression to identify patient, operator, and institutional characteristics associated with TRA use as well as determine the variation in TRA for STEMI PCI from 2009 to 2015. They also described the relationship between operator- and institution-level use and risk-adjusted bleeding and mortality.

Results

Among 692,433 patients undergoing STEMI PCI, 12% (n = 82,618) utilized TRA. TRA increased from 2% to 23% from 2009 to 2015, but with significant geographic variation. Age, sex, cardiogenic shock, cardiac arrest, operators entering practice before 2012, and nonacademically affiliated institutions were associated with lower rates of TRA. There was significant operator and institutional variation, wherein identical patients would have >8-fold difference in odds of TRA for STEMI PCI by changing operators (median odds ratio: 8.7), and >5-fold difference by changing institutions (median odds ratio: 5.1). Greater TRA use across operators was associated with reduced bleeding (rho = –0.053), whereas TRA use across institutions was associated with reduced mortality (rho = –0.077).

Conclusions

Transradial access for STEMI PCI is increasing, but remains underutilized with significant geographic, operator, and institutional variation. These findings suggest an ongoing opportunity to standardize STEMI care.





Transradial Access for Primary Percutaneous Coronary Intervention: Catching On and Catching Up




Impact of Access Site Practice on Clinical Outcomes in Patients Undergoing Percutaneous Coronary Intervention Following Thrombolysis for ST-Segment Elevation Myocardial Infarction in the United Kingdom: An Insight From the British Cardiovascular Intervention Society Dataset
AbstractObjectives

This study sought to examine the relationship between access site practice and clinical outcomes in patients requiring percutaneous coronary intervention (PCI) following thrombolysis for ST-segment elevation myocardial infarction (STEMI).

Background

Transradial access (TRA) is associated with better outcomes in patients requiring PCI for STEMI. A significant proportion of STEMI patients may receive thrombolysis before undergoing PCI in many countries across the world. There are limited data around access site practice and its associated outcomes in this cohort of patients.

Methods

The author used the British Cardiovascular Intervention Society dataset to investigate the outcomes of patients undergoing PCI following thrombolysis between 2007 and 2014. Patients were divided into TRA and transfemoral access groups depending on the access site used. Multiple logistic regression and propensity score matching were used to study the association of access site with in-hospital and long-term mortality, major bleeding, and access site–related complications.

Results

A total of 10,209 patients received thrombolysis and PCI during the study time. TRA was used in 48% (n = 4,959) of patients; 3.3% (n = 336) patients died in hospital, 1.6% (n = 165) of patients experienced major bleeding, 4.2% (n = 437) experienced major adverse cardiac events (MACE), and 4.6% (n = 468) experienced 30-day mortality. After multivariate adjustment, TRA was associated with significantly reduced odds of in-hospital mortality (odds ratio [OR]: 0.59; 95% confidence interval [CI]: 0.42 to 0.83; p = 0.002), major bleeding (OR: 0.45; 95% CI: 0.31 to 0.66; p < 0.001), MACE (OR: 0.72; 95% CI: 0.55 to 0.94; p = 0.01), and 30-day mortality (OR: 0.72; 95% CI: 0.55 to 0.94; p = 0.01).

Conclusions

TRA is associated with decreased odds of bleeding complications, mortality, and MACE in patients undergoing PCI following thrombolysis and should be preferred access site choice in this cohort of patients.





25 Years of Transradial Intervention: Looking Back and Anticipating What Is Ahead




Transfemoral Approach for Coronary Angiography and Intervention: A Collaboration of International Cardiovascular Societies
AbstractObjectives

The aim of this study was to examine the current practice and use of transfemoral approach (TFA) for coronary angiography and intervention.

Background

Wide variability exists in TFA techniques for coronary procedures.

Methods

The authors developed a survey instrument that was distributed via e-mail lists from professional societies to interventional cardiologists from 88 countries between March and December 2016.

Results

Of 987 operators, 18% were femoralists, 38% radialists, 42% both, and 2% neither. Access using femoral pulse palpation alone was preferred by 60% of operators, fluoroscopy guidance by 11%, and a combination of palpation, fluoroscopy, or ultrasound by 27%. Only 11% used micropuncture in >90% of their cases. Performing femoral angiography immediately after access was preferred by 23% and at the end of the procedure by 47%, and not done at all by 31% of operators. Hemostasis by manual compression was preferred by 50%, collagen plug vascular closure device by 31%, and suture-based vascular closure device by 11% of operators. Judkins left and right catheters were preferred for diagnostic angiography of the left (99%) and right (94%) coronary arteries. Extra backup curves (XB or EBU) were most commonly preferred for percutaneous coronary intervention of the left anterior descending (80%) and left circumflex (80%), whereas the Judkins right catheter was preferred for percutaneous coronary intervention of the right coronary artery (86%).

Conclusions

There is significant variability in preferences for femoral access technique. Even though recommended best practices advocate for fluoroscopic and ultrasound guidance, most operators use palpation alone. Femoral angiography is also not consistently used despite guideline recommendations. The lack of adoption of imaging guidance for vascular access deserves further investigation.





Palpate-and-Stick, Still the Femoral Access Technique of Choice: Time for Change




Long-Term Health Benefit of Transcatheter Aortic Valve Replacement in Patients With Chronic Lung Disease
AbstractObjectives

This study sought to characterize the long-term effect of chronic lung disease (CLD) on mortality, clinical outcomes, quality of life, and health benefits after transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis.

Background

The long-term effect of CLD after TAVR is unknown.

Methods

Prevalence and severity of CLD was determined at baseline in high- and extreme-risk patients with aortic stenosis from the CoreValve US Pivotal Trial. Clinical outcomes and health status were assessed using the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS). A favorable health benefit was defined as alive with a KCCQ-OS ≥60 and stability (<10-point decrease) or improvement in the KCCQ-OS from baseline.

Results

CLD was present in 55% (20% mild, 13% moderate, 22% severe) of the 1,030 patients studied. All-cause mortality was higher in patients with moderate and severe CLD at 1 year (19.6% mild, 28.1% moderate, 26.9% severe CLD vs. 19.2% non-CLD; p = 0.030) and 3 years (44.8% mild, 53.0% moderate, 51.9% severe vs. 37.7% non-CLD; p < 0.001). New York Heart Association functional class improved in more than 80% of patients with CLD at 1 and 3 years. All patients had a nearly 20-point improvement in KCCQ-OS at 1 and 3 years. However, only 43.3% of patients with CLD had a favorable health benefit at 1 year and 22.5% at 3 years.

Conclusions

Moderate and severe CLD increases 1- and 3-year mortality after TAVR. Although functional status and quality of life were improved in CLD at 1 and 3 years after TAVR, a favorable health benefit was only achieved in selected patients. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)





Transcatheter Aortic Valve Replacement in Patients With Chronic Lung Disease: Utile or Futile?




Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement Significantly Reduces Death and Stroke Compared With Unprotected Procedures
AbstractObjectives

The aim of this study was to evaluate the impact of cerebral embolic protection on stroke-free survival in patients undergoing transcatheter aortic valve replacement (TAVR).

Background

Imaging data on cerebral embolic protection devices have demonstrated a significant reduction in number and volume of cerebral lesions.

Methods

A total of 802 consecutive patients were enrolled. The Sentinel cerebral embolic protection device (Claret Medical Inc., Santa Rosa, California) was used in 34.9% (n = 280) of consecutive patients. In 65.1% (n = 522) of patients TAVR was performed in the identical setting except without cerebral embolic protection. Neurological follow-up was done within 7 days post-procedure. The primary endpoint was a composite of all-cause mortality or all-stroke according to Valve Academic Research Consortium-2 criteria within 7 days. Propensity score matching was performed to account for possible confounders.

Results

Both filters of the device were successfully positioned in 280 of 305 (91.8%) consecutive patients. With use of cerebral embolic protection rate of disabling and nondisabling stroke was significantly reduced from 4.6% to 1.4% (p = 0.03; odds ratio: 0.29, 95% confidence interval: 0.10 to 0.93) in the propensity-matched population (n = 560). The primary endpoint occurred significantly less frequently, with 2.1% (n = 6 of 280) in the protected group compared with 6.8% (n = 19 of 280) in the control group (p = 0.01; odds ratio: 0.30; 95% confidence interval: 0.12 to 0.77). In multivariable analysis Society of Thoracic Surgeons score for mortality (p = 0.02) and TAVR without protection (p = 0.02) were independent predictors for the primary endpoint.

Conclusions

In patients undergoing TAVR use of a cerebral embolic protection device demonstrated a significant higher rate of stroke-free survival compared with unprotected TAVR.





Routine Use of Embolic Protection During Transcatheter Aortic Valve Replacement




Heterogeneity of Ankle-Brachial Indices in Patients Undergoing Revascularization for Critical Limb Ischemia
AbstractObjectives

This study sought to describe the distribution of pre-intervention treated-limb ankle-brachial indices (ABIs) among patients with critical limb ischemia (CLI) undergoing percutaneous vascular intervention (PVI) or surgical revascularization (SR).

Background

CLI is diagnosed by the presence of rest pain, tissue ulceration, or gangrene due to chronic arterial insufficiency. It is unclear what fraction of patients with suspected CLI have severe peripheral artery disease (PAD) on noninvasive functional testing.

Methods

The study included patients who underwent lower extremity revascularization for CLI in a multicenter registry in Michigan from January 2012 through June 2015. ABIs were classified as normal (ABI: 0.91 to 1.40), mild-moderate (ABI: 0.41 to 0.90), and severe (ABI: ≤0.40). Pre- and post-intervention Peripheral Artery Questionnaire summary scores were assessed in a subset of patients.

Results

Among 10,756 patients with signs or symptoms of CLI, 9,113 (84.7%) underwent PVI and 1,643 (15.3%) underwent SR. ABIs were recorded in 4,972 (54.6%) PVI and 1,012 (61.6%) SR patients. Patients undergoing PVI had higher ABIs than those undergoing SR, with substantial variation in both groups (PVI: 0.72 ± 0.29 vs. SR: 0.61 ± 0.29; p < 0.001). Nearly a quarter of patients with compressible arteries had normal ABIs (24.0%), whereas severe PAD was uncommon (16.5%). A significant improvement in Peripheral Artery Questionnaire scores was noted after intervention across all ABI categories.

Conclusions

Among patients undergoing revascularization for CLI in contemporary practice, the authors found substantial heterogeneity in pre-intervention ABIs. The disconnect between ABI results and clinical diagnosis calls into question the utility of ABIs in this population and suggests the need for standardization of functional PAD testing.





Time to Redefine Critical Limb Ischemia




1-Year Results of a Multicenter Randomized Controlled Trial Comparing Heparin-Bonded Endoluminal to Femoropopliteal Bypass
AbstractObjectives

This study sought to compare heparin-bonded endografts with femoropopliteal bypass, including quality of life, using general health and disease-specific questionnaires as well as patency rates.

Background

Endovascular treatment continues to advance and is gaining acceptance as primary treatment for long occlusive or stenotic lesions in the superficial femoral artery. Heparin-bonded expanded polytetrafluoroethylene endografts have been related to outcomes comparable to bypass surgery, but this has not been tested in a randomized fashion.

Methods

A multicenter randomized-controlled trial was performed comparing femoropopliteal bypass with heparin-bonded expanded polytetrafluoroethylene endografts. Data were analyzed on an intention-to-treat and per-protocol manner.

Results

A total of 129 patients were randomized and 125 patients were treated, 63 in the endoluminal and 62 in the surgical group (42 venous, 20 prosthetic). Enrollment was terminated before reaching the predefined target number for patency. Baseline characteristics and anatomical data were similar. Patients were treated for critical limb ischemia in 38.1% and 32.2% in the endoluminal and surgical arms, respectively. Mean lesion length was 23 cm in both groups and lesions were largely TransAtlantic Inter-Society Consensus II D. Hospitalization time and 30-day morbidity were significantly lower in the endoluminal group, without differences in serious adverse events (n = 5 each; surgical: 4 venous and 1 polytetrafluoroethylene bypass). There were no significant differences in Rutherford category between groups at any time point. At 30 days the endoluminal group showed a greater improvement in quality-of-life scores. At 1 year, these differences had largely disappeared and no differences in primary (endoluminal: 64.8%; surgical: 63.6%), assisted primary (endoluminal: 78.1%; surgical: 79.8%), secondary patency (endoluminal: 85.9%; surgical: 83.3%), and target vessel revascularization (endoluminal: 72.1%; surgical: 71.0%) were observed. Limb salvage rate was 100% in both groups.

Conclusions

Heparin-bonded endoluminal bypass for long segment lesions shows promising results (less morbidity, faster recovery, and improvement in quality of life with indistinguishable patency rates at 1 year) compared with surgical bypass. Long-term results have to be awaited.





Stent Versus Scalpel in Peripheral Artery Disease: The Battle Continues to Rage On




Re-Evaluating the Safety of Drug-Eluting Stents in Cancer Patients
Abstract

Evidence increasingly shows that cancer and coronary artery disease are interlinked through common risk factors, co-occurrence in an aging population, and through the deleterious effects of cancer treatment on cardiovascular health. Many of the clinical risk factors for cancer, such as diabetes, smoking, and chronic inflammatory state, are also risk factors for coronary artery disease and for stent restenosis and thrombosis. The current generations of drug-eluting stents have been proven to reduce the risk of restenosis and stent thrombosis as compared with bare-metal stents. However, because of the perceived need for shorter course of dual antiplatelet treatment, operators often prefer bare-metal stents in patients with cancer out of concern for increased bleeding risk and expectant need for cancer-directed surgery. The current evidence with newer-generation stent technology demonstrates the feasibility of shorter duration of dual antiplatelet treatment, without increasing the risk of stent thrombosis and bleeding, while maintaining improved efficacy compared with bare-metal stents. Cardiovascular disease in patients with cancer is complex, and treatment needs to be individualized. Refraining from the use of drug-eluting stents altogether in this rapidly expanding cohort may lead to higher major adverse cardiovascular events, which can thwart the effectiveness of advances in both cancer and cardiovascular therapeutics. Considering the developing evidence thus far, perhaps it is time to rethink the choice of stent in patients with cancer who undergo percutaneous coronary intervention.





Optical Coherence Tomography Assessment Prevented Unnecessary Intervention in an "Ambiguous" Angiographic Image




Multiple Mechanisms in 1 In-Stent Restenosis Assessed by Optical Coherence Tomography




Repeated Intracoronary Imaging in Spontaneous Coronary Artery Dissection: Weighing Benefits and Risks




Reply: Repeated Intracoronary Imaging in Spontaneous Coronary Artery Dissection: Weighing Benefits and Risks




Research and Therapeutic Nihilisms in Chronic Kidney Disease




Reply: Research and Therapeutic Nihilisms in Chronic Kidney Disease




Prognostic Implications of Pre-Procedural High-Sensitivity Cardiac Troponin T in Patients Undergoing Transcatheter Aortic Valve Replacement




Research Correspondence: One Good Point, One Great Figure (or Table)




Hypoxemia Due to Patent Foramen Ovale in the Setting of New Right Hemidiaphragmatic Paralysis




Lower Limb Bone Metastasis Discovered After Femoropopliteal Artery Stenting




Retrograde Variant Artery Approach for Infrapopliteal Chronic Total Occlusion Intervention




Functional Tricuspid Regurgitation After Transcatheter Closure of Atrial Septal Defect in Adult Patients: Long-Term Follow-Up
AbstractObjectives

This study aimed to assess the fate of tricuspid regurgitation (TR) after transcatheter atrial septal defect (ASD) closure.

Background

Although TR frequently occurs in patients with ASD, the change in TR during long-term follow-up after ASD closure remains unknown.

Methods

A total of 419 adult patients who underwent transcatheter ASD closure were enrolled. TR severity was graded by TR jet area on echocardiography.

Results

At baseline, 113 patients had severe/moderate TR and 306 patients had mild TR. Among the 113 patients with severe/moderate TR, the TR jet area significantly decreased during a median follow-up of 30 months after the procedure; this decrease was related to the improvement in right ventricular morphology. The severity of TR decreased to mild in 79 (70%) patients. Persistent TR, defined as severe or moderate TR after the procedure, was independently associated with the prevalence of permanent atrial fibrillation. Regarding clinical outcomes, 7 patients with severe/moderate TR and 2 with mild TR were hospitalized because of heart failure. Patients with severe/moderate TR had the worse event-free survival rate than those with mild TR, but more than 90% of them had no cardiovascular events. New York Heart Association functional class and plasma B-type natriuretic peptide levels improved in patients with severe/moderate TR, similar to those with mild TR.

Conclusions

Significant TR decreased during the long-term follow-up period after transcatheter ASD closure. Heart failure symptoms improved in patients with severe/moderate TR. Our findings suggest that transcatheter closure alone can be valuable in patients with ASD complicated with TR.





Strategies for Managing Functional Tricuspid Regurgitation in Adults With a Secundum Atrial Septal Defect




Transseptal Puncture Through Amplatzer Atrial Septal Occluder for Left Atrial Appendage Closure




Left Atrial Appendage Occlusion in the Presence of Thrombus With a LAmbre Device




Transcatheter Closure of Perimembranous Ventricular Septal Defects With Amplatzer Duct Occluders




Transcatheter Patent Foramen Ovale Closure After Cryptogenic Stroke: An Updated Meta-Analysis of Randomized Trials




CTO--Chronic Total Occlusions and Continuous Training Opportunity




Clinical Endpoints and Key Data Elements in Percutaneous Coronary Intervention of Coronary Chronic Total Occlusion Studies: A Call to the Academic Research Consortium for Standardized Definitions




Percutaneous Left Atrial Appendage Closure With the LAmbre Device for Stroke Prevention in Atrial Fibrillation: A Prospective, Multicenter Clinical Study
AbstractObjectives

The authors sought to assess the clinical outcomes of left atrial appendage (LAA) closure with the LAmbre closure system in patients with nonvalvular atrial fibrillation (NVAF).

Background

Over 90% of thrombi are located in the LAA in NVAF patients.

Methods

A prospective, multicenter study was conducted in 153 NVAF patients with CHADS2 score ≥1.

Results

The LAA was successfully occluded in 152 patients. Serious complications occurred in 5 patients. During the 12-month follow-up, ischemic stroke occurred in 2 patients, 1 patient had incomplete LAA sealing, and there was no device embolization.

Conclusions

LAA closure with the LAmbre device shows encouraging results for stroke prevention.





Left Atrial Appendage Closure: Continuous Progress With Remaining Challenges




Intracardiac Echocardiography From the Left Atrium for Procedural Guidance of Transcatheter Left Atrial Appendage Occlusion
AbstractObjectives

The aim of this study was to compare the efficacy and safety of intracardiac echocardiography (ICE) from the left atrium (LA) with transesophageal echocardiography (TEE) for procedural guidance of transcatheter left atrial appendage occlusion (LAAO).

Background

TEE with general anesthesia is the current gold standard to guide LAAO. By the use of ICE from the LA, LAAO can be performed in local anesthesia and may potentially have advantages over TEE.

Methods

A single-center, cohort study of patients undergoing LAAO with the Amplatzer Cardiac Plug or Amulet (St. Jude Medical, St. Paul, Minnesota). Procedures were guided by ICE from the LA with local anesthesia (n = 109) or TEE using general anesthesia (n = 107). All patients had pre-procedural cardiac computed tomography. Efficacy outcomes were technical success, procedural success, and peridevice leakage at TEE 8 weeks after LAAO. Safety outcome was a composite of periprocedural complications.

Results

Technical success was achieved in 99% of both the TEE and ICE group. Procedural success was similar between groups: 94.4% success rate in the TEE-guided group, and 94.5% in the ICE-guided group. Major periprocedural complications occurred in 4.7% of the TEE group and 1.8% of the ICE group. Rate and degree of peridevice leak did not differ between groups at follow-up. Turnover time in the catheter laboratory, and contrast use were reduced with ICE.

Conclusions

LA ICE to guide LAAO as compared with TEE appears to be effective and safe, without increased procedure-related complications. The rate of peridevice leak is low and similar to TEE-guided procedures. Time spent in the catheterization room may decrease substantially.





Intracardiac Echocardiography for Endovascular Left Atrial Appendage Closure: Is it Ready for Primetime?




A New Algorithm for Crossing Chronic Total Occlusions From the Asia Pacific Chronic Total Occlusion Club
Abstract

Although the hybrid chronic total occlusion (CTO) algorithm had many excellent recommendations, there has been infrequent adoption in the Asia Pacific region. The Asia Pacific CTO club propose an algorithm for case selection based on the Japan-CTO score and a new CTO algorithm, which is applicable globally. This algorithm allows for differing skill sets and equipment availability and contains practical teaching for CTO percutaneous coronary intervention. Similar to the hybrid algorithm there are 3 main questions that determine whether the primary approach is antegrade or retrograde: 1) is there proximal cap ambiguity; 2) is the distal vessel of poor quality; and 3) are there interventional collaterals present. In contrast to the hybrid algorithm occlusion length alone does not determine the choice of either a wire escalation strategy or a dissection re-entry strategy. Rather a combination of factors including ambiguity of the vessel course, severe calcification, tortuosity, length, and previous failure are used to determine this. The role of intravascular ultrasound–guided entry to overcome proximal cap ambiguity and the CrossBoss catheter in occlusive in-stent restenosis are highlighted in the algorithm. Both the parallel wire technique and dissection re-entry with the Stingray system have been included as options when the initial antegrade wire passage fails. Intravascular ultrasound–guided wiring along with limited subintimal tracking and re-entry are included as final options in the algorithm. Finally, the algorithm incorporates guidance on when to stop the procedure. It is hoped that this algorithm will serve as the basis for future CTO percutaneous coronary intervention proctoring and training.





Outcomes of Percutaneous Coronary Interventions for Chronic Total Occlusion Performed by Highly Experienced Japanese Specialists: The First Report From the Japanese CTO-PCI Expert Registry
AbstractObjectives

This report describes the registry and presents an initial analysis of outcomes for the different PCI approaches taken by the specialists.

Background

Strategies for percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) are complex. The Japanese Board of CTO Interventional Specialists has developed a prospective, nonrandomized registry of patients undergoing CTO-PCIs performed by 41 highly experienced Japanese specialists.

Methods

Over the study period of January 2014 to December 2015, the registry included 2,846 consecutive CTO-PCI cases undertaken in Japan. The authors compared clinical outcomes between the different PCI approaches, following the intention-to-treat principle.

Results

The overall technical success rate of the procedures was 89.9%. The specialists frequently chose a retrograde approach as the primary CTO-PCI strategy (in 27.8% of cases). The technical success rate of the primary antegrade approach was significantly better than that of the primary retrograde approach (91.0% vs. 87.3%; p < 0.0001). The technical success rate decreased to 78.0% with the rescue retrograde approach. Parallel guidewire crossing and intravascular ultrasound–guided wire crossing were performed after guidewire escalation during antegrade CTO-PCI with a high technical success rate (75.0% to 88.9%). Severe lesion calcification was a strong predictor of failed CTO-PCI.

Conclusions

CTO-PCI performed by highly experienced specialists achieved a high technical success rate.





Percutaneous Treatment of Chronic Total Coronary Occlusions: The Light That Came From Japan




Percutaneous Coronary Intervention of Chronic Total Occlusions in Patients With Low Left Ventricular Ejection Fraction
AbstractObjectives

The study sought to assess the outcome of percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) in patients with low left ventricular ejection fraction (LVEF) (≤35%).

Background

Data regarding the outcome of PCI in patients with low LVEF affected by CTO are scarcely reported.

Methods

The authors performed a prospective longitudinal multicenter study including consecutive patients undergoing elective PCI of CTOs. Patients were subdivided into 3 groups: group 1 (LVEF ≥50%), group 2 (LVEF 35% to 50%), and group 3 (LVEF ≤35%).

Results

A total of 839 patients (mean 64.6 ± 10.5 years of age, 87.7% men) underwent CTO PCI attempts. Baseline LVEF ≤35% was present in 72 (8.6%) patients. The angiographic success was high (overall 93.6%) and similar among the 3 groups (93.5% vs. 94.4% vs. 91.7%, respectively; all p = NS). In group 3, no periprocedural complications of CTO PCI were observed. Mean clinical follow-up of 16.3 ± 8.2 months duration was available in 781 (93.1%) patients including those with LVEF ≤35%. At 2 years, major cardiac and cerebrovascular events (MACCE) free survival was similar in the 3 groups (86% vs. 82.8% vs. 75.2%; all p = NS). In patients with LVEF ≤35%, LVEF improved significantly in the presence of a successful CTO PCI from 29.1 ± 3.4% to 41.6 ± 7.9% (p < 0.001).

Conclusions

In CTO patients with low LVEF, PCI could represent a safe and effective revascularization strategy achieving good midterm outcome and LVEF improvement.





Chronic Total Occlusion Trials: A Step in the Right Direction




Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention in Patients With Diabetes: Insights From the OPEN CTO Registry
AbstractObjectives

Few studies have evaluated the relationship of diabetes with technical success and periprocedural complications, and no studies have compared patient-reported health status after chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in patients with and without diabetes.

Background

CTOs are more common in patients with diabetes, yet CTO PCI is less often attempted in patients with diabetes than in patients without. The association between diabetes and health status after CTO PCI is unknown.

Methods

In the 12-center OPEN-CTO PCI registry (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Registry), patients with and without diabetes were assessed for technical success, periprocedural complications, and health status over 1 year following CTO PCI using the Seattle Angina Questionnaire and the Rose Dyspnea Scale. Hierarchical modified Poisson regression was used to examine the independent association between diabetes and technical success, and hierarchical multivariable linear regression was used to assess the association between diabetes and follow-up health status.

Results

Diabetes was common (41.2%) and associated with a lower crude rate of technical success (83.5% vs. 88.1%; p = 0.04). After adjustment, there was no significant difference between diabetic and nondiabetic patients (relative risk: 0.96, 95% confidence interval: 0.91 to 1.01). There were no significant differences in complication rates between patients with and without diabetes. Angina burden, quality of life, and overall health status scores were similar between diabetic and nondiabetic patients over 1 year.

Conclusions

Although technical success was lower in patients with diabetes, this reflected lower success among patients with prior bypass surgery, without any significant difference in success rate after adjusting for prior bypass and disease complexity. CTO PCI complication rates are similar in diabetic and nondiabetic patients, and symptom improvement following CTO PCI is robust and of a similar magnitude regardless of diabetes status.





CTO PCI in Patients With Diabetes Mellitus: Sweet Perspectives




Simultaneous TAVR and Left Main "Chimney" Stenting in a Patient With Low Left Main Height




Treatment of an Acute Limb Due to Inferior Vena Cava Filter Thrombosis




3-Dimensional SPECT/CT Fusion Imaging-Guided Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension




Associations Between Chronic Kidney Disease and Outcomes With Use of Prasugrel Versus Clopidogrel in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: A Report From the PROMETHEUS Study
AbstractObjectives

This study sought to compare clinical outcomes in a contemporary acute coronary syndrome (ACS) percutaneous coronary intervention (PCI) cohort stratified by chronic kidney disease (CKD) status.

Background

Patients with CKD exhibit high risks for both thrombotic and bleeding events, thus complicating decision making regarding antiplatelet therapy in the setting of ACS.

Methods

The PROMETHEUS study was a multicenter observational study comparing outcomes with prasugrel versus clopidogrel in ACS PCI patients. Major adverse cardiac events (MACE) at 90 days and at 1 year were defined as a composite of death, myocardial infarction, stroke, or unplanned revascularization. Clinically significant bleeding was defined as bleeding requiring transfusion or hospitalization. Cox regression multivariable analysis was performed for adjusted associations between CKD status and clinical outcomes. Hazard ratios for prasugrel versus clopidogrel treatment were generated using propensity score stratification.

Results

The total cohort included 19,832 patients, 28.3% with and 71.7% without CKD. CKD patients were older with greater comorbidities including diabetes and multivessel disease. Prasugrel was less often prescribed to CKD versus non-CKD patients (11.0% vs. 24.0%, respectively; p < 0.001). At 1 year, CKD was associated with higher adjusted risk of MACE (1.27; 95% confidence interval: 1.18 to 1.37) and bleeding (1.46; 95% confidence interval: 1.24 to 1.73). Although unadjusted rates of 1-year MACE were lower with prasugrel versus clopidogrel in both CKD (18.3% vs. 26.5%; p < 0.001) and non-CKD (10.9% vs. 17.9%; p < 0.001) patients, associations were attenuated after propensity stratification. Similarly, unadjusted differences in 1-year bleeding with prasugrel versus clopidogrel (6.0% vs. 7.4%; p = 0.18 in CKD patients; 2.6% vs. 3.5%; p = 0.008 in non-CKD patients) were not significant after propensity score adjustment.

Conclusions

Although risks for 1-year MACE were significantly higher in ACS PCI patients with versus without CKD, prasugrel use was 50% lower in patients with renal impairment. Irrespective of CKD status, outcomes associated with prasugrel use were not significant after propensity adjustment. These data highlight the need for randomized studies evaluating the optimal antiplatelet therapy in CKD patients with ACS.





P2Y12 Inhibitors in Patients With Chronic Kidney Disease: The Known Unknown




The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes
AbstractObjectives

The aim of this first-in-human study was to assess the safety and effectiveness of the Virtue sirolimus-eluting balloon in a cohort of patients with in-stent restenosis (ISR).

Background

Angioplasty balloons coated with the cytotoxic drug paclitaxel have been widely used for ISR treatment. The Virtue angioplasty balloon (Caliber Therapeutics, New Hope, Pennsylvania) delivers sirolimus in a nanoencapsulated liquid formulation. This clinical trial is the first to examine a sirolimus-eluting balloon for ISR.

Methods

In this prospective, single-arm feasibility study at 9 European centers, 50 ISR patients were treated with the Virtue balloon. Angiographic measurements at 6 months are reported, along with 12-month clinical follow-up.

Results

Procedural success in the intention-to-treat population was 100%. The primary safety endpoint was target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) assessed at 30 days (0%, n = 50). The primary performance endpoint was in-segment late lumen loss (LLL) at 6 months (0.31 ± 0.52 mm; n = 47). Secondary 6-month endpoints include binary restenosis (19.1%), diameter stenosis (30.3 ± 19.9%), and major adverse cardiac events (MACE) (10.2%, n = 49). In the 36-patient per-protocol population (excluding major protocol violations and previously stented ISR), LLL was 0.12 ± 0.33 mm at 6 months. Clinical outcomes at 1 year for the intention-to-treat group were 12.2% TLF and 14.3% MACE and for the per-protocol population were 2.8% TLF and 2.8% MACE.

Conclusions

This first-in-human study showed excellent procedural success for the Virtue sirolimus-eluting angioplasty balloon, 6-month LLL rates in line with current stent-free ISR treatment options, and clinical outcomes that warrant further evaluation in dedicated randomized studies.





The Debut of Sirolimus-Eluting Balloons: The Final Nail in the Coffin for In-Stent Restenosis?




Dialysis Following Transcatheter Aortic Valve Replacement: Risk Factors and Outcomes: An Analysis From the UK TAVI (Transcatheter Aortic Valve Implantation) Registry
AbstractObjectives

This study sought to determine the risk factors for post-transcatheter aortic valve replacement (TAVR) dialysis and to determine the impact of pre-TAVR or post-TAVR dialysis on mortality.

Background

TAVR is now established as an alternative treatment to surgical aortic valve replacement. Data examining the impact of dialysis on outcomes after TAVR are lacking.

Methods

The UK TAVI (Transcatheter Aortic Valve Implantation) Registry was established to report outcomes on all TAVR procedures performed within the United Kingdom (2007 to 2014). Data were collected prospectively on 6,464 patients with a median follow-up of 625 days.

Results

The proportion of patients on dialysis before TAVR has remained constant at 1.8%. After TAVR, the proportion of patients newly needing dialysis after TAVR has fallen from 6.1% (2007 to 2008) to 2.3% (2013 to 2014). The risk of new dialysis requirement after TAVR was independently associated with lower baseline renal function, year of procedure, impaired left ventricular function, diabetes, use of an Edwards valve, a nontransfemoral approach, need for open surgery, and moderate-to-severe aortic regurgitation after the procedure. Requirement for new dialysis after TAVR was associated with higher mortality at 30 days (hazard ratio: 6.44; 95% confidence interval: 4.87 to 8.53) and at 4 years (hazard ratio: 3.54; 95% confidence interval: 2.99 to 4.19; p < 0.001 for all) compared with patients without dialysis requirement.

Conclusions

The proportion of patients needing dialysis after TAVR has decreased over time. Post-TAVR dialysis is associated with increased mortality. Factors identified with dialysis requirement after TAVR require further investigation.





The Relationship of Dialysis Risk and Transcatheter Aortic Valve Replacement From the UK TAVI Registry: Study Findings: Some Expected, Some Provocative




Association of Chronic Kidney Disease With In-Hospital Outcomes of Transcatheter Aortic Valve Replacement
AbstractObjectives

This study sought to determine the association of chronic kidney disease (CKD) with in-hospital outcomes of transcatheter aortic valve replacement (TAVR).

Background

CKD is a known independent risk factor for worse outcomes after surgical aortic valve replacement (SAVR). However, data on outcomes of patients with CKD undergoing TAVR are limited, especially in those on chronic dialysis.

Methods

The authors used data from the 2012 to 2014 National Inpatient Sample database to identify all patients ≥18 years of age who underwent TAVR. International Classification of Diseases-Ninth Revision-Clinical Modification codes were used to identify patients with no CKD, CKD (without chronic dialysis), or end-stage renal disease (ESRD) on long-term dialysis. Multivariable logistic regression models were constructed using generalized estimating equations to examine in-hospital outcomes.

Results

Of 41,025 patients undergoing TAVR from 2012 to 2014, 25,585 (62.4%) had no CKD, 13,750 (33.5%) had CKD, and 1,690 (4.1%) had ESRD. Compared with patients with no CKD, in-hospital mortality was significantly higher in patients with CKD or ESRD (3.8% vs. 4.5% vs. 8.3%; adjusted odds ratio [no CKD as reference]: 1.39 [95% confidence interval: 1.24 to 1.55] for CKD and 2.58 [95% confidence interval: 2.09 to 3.13] for ESRD). Patients with CKD or ESRD had a higher incidence of major adverse cardiovascular events (composite of death, myocardial infarction, or stroke), net adverse cardiovascular events (composite of major adverse cardiovascular events, major bleeding, or vascular complications), and pacemaker implantation compared with patients without CKD. Acute kidney injury (AKI) and AKI requiring dialysis were associated with several-fold higher risk-adjusted in-hospital mortality in patients in the no CKD and CKD groups. Moreover, the incidence of AKI and AKI requiring dialysis did not decline during the study period.

Conclusions

Patients with CKD or ESRD have worse in-hospital outcomes after TAVR. AKI is associated with higher in-hospital mortality in patients undergoing TAVR and the incidence of AKI has not declined over the years.





Fixing the Valve, But Injuring the Kidneys, With Transcatheter Aortic Valve Replacement: Collateral Damage With Serious Consequences




Death and Dialysis After Transcatheter Aortic Valve Replacement: An Analysis of the STS/ACC TVT Registry
AbstractObjectives

The authors sought to elucidate the true incidence of renal replacement therapy (RRT) after transcatheter aortic valve replacement (TAVR).

Background

There is a wide discrepancy in the reported rate of RRT after TAVR (1.4% to 40%). The true incidence of RRT after TAVR is unknown.

Methods

The STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) registry was linked to the Centers for Medicare & Medicaid database to identify all patients that underwent TAVR from November 2011 through September 2015 and their outcomes. The authors compared rates of death, new RRT, and a composite of both as a function of pre-procedure glomerular filtration rate (GFR), both in stages of chronic kidney disease (CKD), as well as on a continuous scale.

Results

Pre-procedure GFR is associated with the risk of death and new RRT after TAVR when GFR is <60 ml/min/m2, and increases significantly when GFR falls below 30 ml/min/m2. Incremental increases in GFR of 5 ml/min/m2 were statistically significant (unadjusted hazard ratio: 0.71; p < 0.001) at 30 days, and continued to be significant at 1 year when pre-procedure GFR was <60 ml/min/m2. One in 3 CKD stage 4 patients will be dead within 1 year, with 14.6% (roughly 1 in 6) requiring dialysis. In CKD stage 5, more than one-third of patients will require RRT within 30 days; nearly two-thirds will require RRT at 1 year.

Conclusions

In both unadjusted and adjusted analysis, pre-procedural GFR was associated with the outcomes of death and new RRT. Increasing CKD stage leads to an increased risk of death and/or RRT. Continuous analysis showed significant differences in outcomes in all levels of CKD when GFR was <60 ml/min/m2. Pre-procedure GFR should be considered when selecting CKD patients for TAVR.





The Plan Was to Replace the Valve, Not the Kidneys




Multicenter Comparison of Novel Self-Expanding Versus Balloon-Expandable Transcatheter Heart Valves
AbstractObjectives

This study sought to compare 2 next-generation transcatheter heart valves (THV), the self-expanding ACURATE neo (NEO) and the balloon-expandable SAPIEN 3 (S3), in terms of device failure and early safety at 30 days.

Background

Deployment of these THV showed promising initial clinical results. However, no comparative data are available.

Methods

Of 1,121 treated patients at 3 centers, a 1-to-2 nearest neighbor matching was performed to identify 2 patients treated with S3 (n = 622) for each patient treated with NEO (n = 311).

Results

In-hospital complications were comparable between NEO and S3, including stroke (1.9% vs. 2.4%; p = 0.64), major vascular complications (10.3% vs. 8.5%; p = 0.38), or life-threatening bleeding (4.2% vs. 3.7%; p = 0.72). Device failure with NEO was comparable with S3 (10.9% vs. 9.6%; odds ratio: 1.09 [95% confidence interval: 0.69 to 1.73]; p = 0.71) with more paravalvular leakage (PVL II+, 4.8% vs. 1.8%; p = 0.01), but less elevated gradients (≥20 mm Hg, 3.2% vs. 6.9%; p = 0.02) and pacemaker implantations (9.9% vs. 15.5%; p = 0.02). Thirty-day mortality (2.3% vs. 1.9%; p = 0.74) and the early safety composite endpoint (15.8% vs. 15.6%; hazard ratio: 0.97 [95% confidence interval: 0.68 to 1.39]; p = 0.88) were similar with NEO and S3.

Conclusions

Very high success rates were achieved for both valves, and the clinical and procedural results were comparable. Compared with S3, NEO was associated with less new pacemaker implantations and less elevated gradients, but with more paravalvular leakage.





A Comparison of the ACURATE Neo and Sapien 3 Valves: Making Progress




Outcomes for the Commercial Use of Self-Expanding Prostheses in Transcatheter Aortic Valve Replacement: A Report From the STS/ACC TVT Registry
AbstractObjectives

The authors sought to compare the outcomes of commercial transcatheter aortic valve replacement (TAVR) with the repositionable Evolut R platform to those observed with the CoreValve device in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry.

Background

TAVR continues to evolve, with rapid adoption of iterative changes for commercial practice. Insight into the outcomes of this adoption is needed.

Methods

Patients in the TVT Registry who had TAVR using a 23-, 26-, or 29-mm self-expanding prosthesis were enrolled. Site-reported events for procedural, in-hospital, and 30-day outcomes were examined.

Results

Between January 2014 and April 2016, 9,616 patients underwent TAVR with a self-expanding prosthesis with data entered in the TVT Registry. Compared with patients treated with CoreValve TAVR, those who received Evolut R TAVR had a lower STS-PROM score (8.0 ± 5.4% vs. 8.7 ± 5.3%; p < 0.001), more iliofemoral access (91.6% vs. 89.2%; p < 0.001), and more frequently had conscious sedation (27.4% vs. 12.7%; p < 0.001). With Evolut R TAVR, there was less need for a second prosthesis (2.2% vs. 4.5%; p < 0.001), less device migration (0.2% vs. 0.6%; p = 0.01), a lower incidence of moderate/severe paravalvular regurgitation (post-procedure, 4.4% vs. 6.2%; p < 0.001), and shorter median hospital stay (4.0 vs. 5.0 days; p < 0.001). Patients treated with Evolut R TAVR had greater device success (96.3% vs. 94.9%; p = 0.001). At 30 days, Evolut R patients had both lower mortality (3.7% vs. 5.3%; p < 0.001) and less need for a pacemaker (18.3% vs. 20.1%; p = 0.03).

Conclusions

Commercial adoption of the Evolut R platform is associated with significant improvements in acute outcomes for patients undergoing TAVR for aortic stenosis.





The Results of Transcatheter Aortic Valve Replacement Continue to Improve: The Specific Example of a Self-Expandable Transcatheter Heart Valve in a Real-Life Registry




Nationwide Trends in Hospital Outcomes and Utilization After Lower Limb Revascularization in Patients on Hemodialysis
AbstractObjectives

This study aimed to describe the temporal trends and outcomes of endovascular and surgical revascularization in a large, nationally representative sample of patients with end-stage renal disease on hemodialysis hospitalized for peripheral artery disease (PAD).

Background

PAD is prevalent among patients with end-stage renal disease on hemodialysis and is associated with significant morbidity and mortality. There is a paucity of information on trends in endovascular and surgical revascularization and post-procedure outcomes in this population.

Methods

We used the Nationwide Inpatient Sample (2002 to 2012) to identify hemodialysis patients undergoing endovascular or surgical procedures for PAD using diagnostic and procedural codes. We compared trends in amputation, post-procedure complications, mortality, length of stay, and costs between the 2 groups using trend tests and logistic regression.

Results

There were 77,049 endovascular and 29,556 surgical procedures for PAD in hemodialysis patients. Trend analysis showed that endovascular procedures increased by nearly 3-fold, whereas there was a reciprocal decrease in surgical revascularization. Post-procedure complication rates were relatively stable in persons undergoing endovascular procedures but nearly doubled in those undergoing surgery. Surgery was associated with 1.8 times adjusted odds (95% confidence interval: 1.60 to 2.02) for complications and 1.6 times the adjusted odds for amputations (95% confidence interval: 1.40 to 1.75) but had similar mortality (adjusted odds ratio: 1.05; 95% confidence interval: 0.85 to 1.29) compared with endovascular procedures. Length of stay for endovascular procedures remained stable, whereas a decrease was seen for surgical procedures. Overall costs increased marginally for both procedures.

Conclusions

Rates of endovascular procedures have increased, whereas those of surgeries have decreased. Surgical revascularization is associated with higher odds of overall complications. Further prospective studies and clinical trials are required to analyze the relationship between the severity of PAD and the revascularization strategy chosen.





Trends in Lower Limb Revascularization Among Patients With End-Stage Renal Failure: Where Is the Journey Going, and How Far Have We Come?




Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The IN.PACT Global Study De Novo In-Stent Restenosis Imaging Cohort
AbstractObjectives

This study sought to evaluate the safety and effectiveness of a paclitaxel-coated drug-coated balloon (DCB) for the treatment of patients with de novo in-stent restenosis (ISR).

Background

Treatment of patients with ISR remains a challenge. Current strategies are plagued by high rates of recurrent restenosis and need for reintervention. The best intervention for ISR remains to be elucidated.

Methods

The IN.PACT Global study is an independently adjudicated multicenter, prospective, single-arm study that enrolled 1,535 subjects with symptomatic atherosclerotic disease of the superficial femoral and/or popliteal arteries, including de novo ISR lesions. Patients enrolled in the pre-specified ISR imaging cohort were evaluated for vessel patency and reintervention within the 12-month follow-up period.

Results

A total of 131 subjects with 149 ISR lesions were included for analysis. The mean age of the cohort was 67.8 years. Mean lesion length was 17.17 ± 10.47 cm, including 34.0% total occlusions and 59.1% calcified lesions. The 12-month Kaplan-Meier estimate of primary patency was 88.7%. The rate of clinically driven target lesion revascularization (CD TLR) at 12 months was 7.3%. The primary safety outcome, a composite of freedom from device- and procedure-related mortality through 30 days and freedom from major target limb amputation and CD TLR within 12 months, was 92.7%. There were no major target limb amputations, no deaths, and a low (0.8%) thrombosis rate.

Conclusions

Results from the ISR imaging cohort demonstrate high patency and a low rate of CD TLR at 12 months. These data confirm the safety and effectiveness of the IN.PACT Admiral DCB (Medtronic, Dublin, Ireland) in complex femoropopliteal lesions, including this challenging subset.





Challenges of Stent Restenosis in Superficial Femoral and Popliteal Artery Disease




Transcatheter Closure of Aortic Anastomosis Leak Resulting in Patent Cabrol Shunt After Aortic Replacement




Percutaneous Treatment of a Giant Infected Femoral Artery Pseudoaneurysm




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