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Stroke After Surgical Versus Transfemoral Transcatheter Aortic Valve Replacement in the PARTNER Trial
AbstractBackground

Transfemoral-transcatheter aortic valve replacement (TF-TAVR) is increasingly used to treat aortic stenosis, but risk of post-procedure stroke is uncertain.

Objectives

The purpose of this study was to assess stroke risk and its association with quality of life after surgical aortic valve replacement (SAVR) versus TF-TAVR.

Methods

The authors performed a propensity-matched study of 1,204 pairs of patients with severe aortic stenosis treated with SAVR versus TF-TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valves) trials from April 2007 to October 2014. Outcomes were: 1) 30-day neurological events; 2) time-varying risk of neurological events early (≤7 days) and late (7 days to 48 months) post-procedure; and 3) association between stroke and quality of life 1 year post-procedure by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score.

Results

Thirty-day stroke (5.1% vs. 3.7%; p = 0.09) was similar, but 30-day major stroke (3.9% vs. 2.2%; p = 0.018) was lower after TF-TAVR than SAVR. In both groups, risk of stroke peaked in the first post-procedure day, followed by a near-constant low-level risk to 48 months. Major stroke was associated with a decline in quality of life at 1 year in both SAVR (KCCQ score median [15th, 85th percentile]: 79 [53, 94] without major stroke vs. 64 [30, 94] with major stroke; p = 0.03) and TF-TAVR (78 [49, 96] without major stroke vs. 60 [8, 99] with major stroke; p = 0.04).

Conclusions

Despite similar early-peaking (<1 day post-procedure) neurological risk profiles, SAVR is associated with a higher risk of early major stroke than TF-TAVR. Periprocedural strategies are needed to reduce stroke risk after aortic valve procedures. (Placement of AoRTic TraNscathetER Valve Trial [PARTNER]; NCT00530894)





Deciphering the Unknowns of Stroke After Aortic Valve Interventions




Differences in Risk of Sudden Cardiac Death Between Blacks and Whites
AbstractBackground

Prior studies have consistently demonstrated that blacks have an approximate 2-fold higher incidence of sudden cardiac death (SCD) than whites; however, these analyses have lacked individual-level sociodemographic, medical comorbidity, and behavioral health data.

Objectives

The purpose of this study was to evaluate whether racial differences in SCD incidence are attributable to differences in the prevalence of risk factors or rather to underlying susceptibility to fatal arrhythmias.

Methods

The Reasons for Geographic and Racial Differences in Stroke study is a prospective, population-based cohort of adults from across the United States. Associations between race and SCD defined per National Heart, Lung, and Blood Institute criteria were assessed.

Results

Among 22,507 participants (9,416 blacks and 13,091 whites) without a history of clinical cardiovascular disease, there were 174 SCD events (67 whites and 107 blacks) over a median follow-up of 6.1 years (interquartile range: 4.6 to 7.3 years). The age-adjusted SCD incidence rate (per 1,000 person-years) was higher in blacks (1.8; 95% confidence interval [CI]: 1.4 to 2.2) compared with whites (0.7; 95% CI: 0.6 to 0.9), with an unadjusted hazard ratio of 2.35; 95% CI: 1.74 to 3.20. The association of black race with SCD risk remained significant after adjustment for sociodemographics, comorbidities, behavioral measures of health, intervening cardiovascular events, and competing risks of non-SCD mortality (hazard ratio: 1.97; 95% CI: 1.39 to 2.77).

Conclusions

In a large biracial population of adults without a history of cardiovascular disease, SCD rates were significantly higher in blacks as compared with whites. These racial differences were not fully explained by demographics, adverse socioeconomic measures, cardiovascular risk factors, and behavioral measures of health.





Ancestry and the Promise of Improved Risk Prediction for Sudden Death




Antibiotic Prophylaxis and Incidence of Endocarditis Before and After the 2007 AHA Recommendations
AbstractBackground

The American Heart Association updated its recommendations for antibiotic prophylaxis (AP) to prevent infective endocarditis (IE) in 2007, advising that AP cease for those at moderate risk of IE, but continue for those at high risk.

Objectives

The authors sought to quantify any change in AP prescribing and IE incidence.

Methods

High-risk, moderate-risk, and unknown/low-risk individuals with linked prescription and Medicare or commercial health care data were identified in the Truven Health MarketScan databases from May 2003 through August 2015 (198,522,665 enrollee-years of data). AP prescribing and IE incidence were evaluated by Poisson model analysis.

Results

By August 2015, the 2007 recommendation change was associated with a significant 64% (95% confidence interval [CI]: 59% to 68%) estimated fall in AP prescribing for moderate-risk individuals and a 20% (95% CI: 4% to 32%) estimated fall for those at high risk. Over the same period, there was a barely significant 75% (95% CI: 3% to 200%) estimated increase in IE incidence among moderate-risk individuals and a significant 177% estimated increase (95% CI: 66% to 361%) among those at high risk. In unknown/low-risk individuals, there was a significant 52% (95% CI: 46% to 58%) estimated fall in AP prescribing, but no significant increase in IE incidence.

Conclusions

AP prescribing fell among all IE risk groups, particularly those at moderate risk. Concurrently, there was a significant increase in IE incidence among high-risk individuals, a borderline significant increase in moderate-risk individuals, and no change for those at low/unknown risk. Although these data do not establish a cause–effect relationship between AP reduction and IE increase, the fall in AP prescribing in those at high risk is of concern and, coupled with the borderline increase in IE incidence among those at moderate risk, warrants further investigation.





Preventing Endocarditis: No Rest for the Worrier




Formin Homology 2 Domain Containing 3 (FHOD3) Is a Genetic Basis for Hypertrophic Cardiomyopathy
AbstractBackground

The genetic cause of hypertrophic cardiomyopathy remains unexplained in a substantial proportion of cases. Formin homology 2 domain containing 3 (FHOD3) may have a role in the pathogenesis of cardiac hypertrophy but has not been implicated in hypertrophic cardiomyopathy.

Objectives

This study sought to investigate the relation between FHOD3 mutations and the development of hypertrophic cardiomyopathy.

Methods

FHOD3 was sequenced by massive parallel sequencing in 3,189 hypertrophic cardiomyopathy unrelated probands and 2,777 patients with no evidence of cardiomyopathy (disease control subjects). The authors evaluated protein-altering candidate variants in FHOD3 for cosegregation, clinical characteristics, and outcomes.

Results

The authors identified 94 candidate variants in 132 probands. The variants’ frequencies were significantly higher in patients with hypertrophic cardiomyopathy (74 of 3,189 [2.32%]) than in disease control subjects (18 of 2,777 [0.65%]; p < 0.001) or in the gnomAD database (1,049 of 138,606 [0.76%]; p < 0.001). FHOD3 mutations cosegregated with hypertrophic cardiomyopathy in 17 families, with a combined logarithm of the odds score of 7.92, indicative of very strong segregation. One-half of the disease-causing variants were clustered in a small conserved coiled-coil domain (amino acids 622 to 655); odds ratio for hypertrophic cardiomyopathy was 21.8 versus disease control subjects (95% confidence interval: 1.3 to 37.9; p < 0.001) and 14.1 against gnomAD (95% confidence interval: 6.9 to 28.7; p < 0.001). Hypertrophic cardiomyopathy patients carrying (likely) pathogenic mutations in FHOD3 (n = 70) were diagnosed after age 30 years (mean 46.1 ± 18.7 years), and two-thirds (66%) were males. Of the patients, 82% had asymmetric septal hypertrophy (mean 18.8 ± 5 mm); left ventricular ejection fraction <50% was present in 14% and hypertrabeculation in 16%. Events were rare before age 30 years, with an annual cardiovascular death incidence of 1% during follow-up.

Conclusions

FHOD3 is a novel disease gene in hypertrophic cardiomyopathy, accounting for approximately 1% to 2% of cases. The phenotype and the rate of cardiovascular events are similar to those reported in unselected cohorts. The FHOD3 gene should be routinely included in hypertrophic cardiomyopathy genetic testing panels.





Formins Emerge as a Cause of Hypertrophic Cardiomyopathy: New Genes for Thick Hearts




Dilated Cardiomyopathy Due to BLC2-Associated Athanogene 3 (BAG3) Mutations
AbstractBackground

The BAG3 (BLC2-associated athanogene 3) gene codes for an antiapoptotic protein located on the sarcomere Z-disc. Mutations in BAG3 are associated with dilated cardiomyopathy (DCM), but only a small number of cases have been reported to date, and the natural history of BAG3 cardiomyopathy is poorly understood.

Objectives

This study sought to describe the phenotype and prognosis of BAG3 mutations in a large multicenter DCM cohort.

Methods

The study cohort comprised 129 individuals with a BAG3 mutation (62% males, 35.1 ± 15.0 years of age) followed at 18 European centers. Localization of BAG3 in cardiac tissue was analyzed in patients with truncating BAG3 mutations using immunohistochemistry.

Results

At first evaluation, 57.4% of patients had DCM. After a median follow-up of 38 months (interquartile range: 7 to 95 months), 68.4% of patients had DCM and 26.1% who were initially phenotype-negative developed DCM. Disease penetrance in individuals >40 years of age was 80% at last evaluation, and there was a trend towards an earlier onset of DCM in men (age 34.6 ± 13.2 years vs. 40.7 ± 12.2 years; p = 0.053). The incidence of adverse cardiac events (death, left ventricular assist device, heart transplantation, and sustained ventricular arrhythmia) was 5.1% per year among individuals with DCM. Male sex, decreased left ventricular ejection fraction. and increased left ventricular end-diastolic diameter were associated with adverse cardiac events. Myocardial tissue from patients with a BAG3 mutation showed myofibril disarray and a relocation of BAG3 protein in the sarcomeric Z-disc.

Conclusions

DCM caused by mutations in BAG3 is characterized by high penetrance in carriers >40 years of age and a high risk of progressive heart failure. Male sex, decreased left ventricular ejection fraction, and enlarged left ventricular end-diastolic diameter are associated with adverse outcomes in patients with BAG3 mutations.





The Clinical Course of a Genetic Dilated Cardiomyopathy: Letting the Cat Out of the BAG3




Cardiac Phenotypes in Hereditary Muscle Disorders: JACC State-of-the-Art Review
Abstract

Hereditary muscular diseases commonly involve the heart. Cardiac manifestations encompass a spectrum of phenotypes, including both cardiomyopathies and rhythm disorders. Common biomarkers suggesting cardiomuscular diseases include increased circulating creatine kinase and/or lactic acid levels or disease-specific metabolic indicators. Cardiac and extra-cardiac traits, imaging tests, family studies, and genetic testing provide precise diagnoses. Cardiac phenotypes are mainly dilated and hypokinetic in dystrophinopathies, Emery-Dreifuss muscular dystrophies, and limb girdle muscular dystrophies; hypertrophic in Friedreich ataxia, mitochondrial diseases, glycogen storage diseases, and fatty acid oxidation disorders; and restrictive in myofibrillar myopathies. Left ventricular noncompaction is variably associated with the different myopathies. Conduction defects and arrhythmias constitute a major phenotype in myotonic dystrophies and skeletal muscle channelopathies. Although the actual cardiac management is rarely based on the cause, the cardiac phenotypes need precise characterization because they are often the only or the predominant manifestations and the prognostic determinants of many hereditary muscle disorders.





Operational Efficiency and Effective Management in the Catheterization Laboratory: JACC Review Topic of the Week
Abstract

Operational efficiency is a core business principle in which organizations strive to deliver high-quality goods or services in a cost-effective manner. This concept has become increasingly relevant to cardiac catheterization laboratories, as insurers move away from fee-for-service reimbursement and toward payment determined by quality measures bundled per episode of care. Accordingly, this review provides a framework for optimizing efficiency in the cardiac cath lab. The authors outline a management method based on the Nadler-Tushman Congruence Model, a commonly used business tool by which a company can assess whether its key elements are aligned with its strategy. Standardized metrics of cath lab efficiency are proposed, which can be used in public reports on this topic moving forward. Attention is paid to understanding balance sheets to track the financial health of the cath lab. Specific cost-saving measures are described, and examples of strategies used to save supply expenses are provided.





Developing a Mobile Application for Global Cardiovascular Education
Abstract

Technological revolution in the field of medical education is here, and it is time to embrace it. Adoption of on-the-go learning style, portability of smartphones, and expression of concepts with interactive illustrations and their global reach have made application (app)-based learning an effective medium. An educational mobile app, BIFURCAID, was developed to simplify and teach complex coronary bifurcation intervention. This app has been downloaded worldwide. The survey results revealed its widespread acceptance and success. The authors believe that educational apps can have a significant impact on shaping the future of cardiovascular education in the 21st century. This experience with developing and testing the app could work as a template for other medical educators.





Scaling STEMI Care Internationally: ACCs Global STEMI Quality Improvement Initiative




JACC Serving the Global Cardiovascular Community




Building Bridges in Cardiology and Radiology: Why Collaboration Is the Future of Cardiovascular Imaging




RESPONSE: Collaboration and Collegiality: The Dual Pillars of Cardiovascular Imaging Now and in the Future




HF Mortality Trends Under Medicare Readmissions Reduction Program at Penalized and Nonpenalized Hospitals




CAD Is an Independent Risk Factor for Stroke Among Patients With Atrial Fibrillation




Characterization of Recurrent Strokes With and Without Patent Foramen Ovale Closure




Reply: Understanding the Complex Link Between Cardiac Function and Pre-Eclampsia




Understanding the Complex Link Between Cardiac Function and Pre-Eclampsia




Anticoagulants for Cardioembolism Prevention in Atrial Fibrillation Patients: Potential Bias From Real-World Studies




Reply: Anticoagulants for Cardioembolism Prevention in Atrial Fibrillation Patients: Potential Bias From Real-World Studies




Reply: Sex-Based Differences in Outcomes of Oral Anticoagulation: Does Antiplatelet Therapy Matter?




Sex-Based Differences in Outcomes of Oral Anticoagulation: Does Antiplatelet Therapy Matter?




Correction




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JACC: Cardiovascular Interventions recent issues

JACC: Cardiovascular Interventions RSS feed -- recent issues

Transcatheter Aortic Valve Replacement for Severe Aortic Regurgitation in Singleton-Merten Syndrome




Successful Edge-to-Edge Mitral Repair Using the New MitraClip XTR System Following Rupture of Transapical Implanted NeoChord




Unexpected Measurement Error in Optical Coherence Tomography-Guided Percutaneous Coronary Intervention




Impact of On-Site Cardiac Surgery on Clinical Outcomes After Transfemoral Transcatheter Aortic Valve Replacement
AbstractObjectives

This study sought to investigate the outcome of high-risk and inoperable patients with severe symptomatic aortic stenosis undergoing transfemoral transcatheter aortic valve replacement (TAVR) in hospitals with (iOSCS) versus without institutional on-site cardiac surgery (no-iOSCS).

Background

Current guidelines recommend the use of TAVR only in institutions with a department for cardiac surgery on site.

Methods

In this analysis of the prospective multicenter Austrian TAVI registry, 1,822 consecutive high-risk patients with severe symptomatic aortic stenosis undergoing transfemoral TAVR were evaluated. A total of 290 (15.9%) underwent TAVR at no-iOSCS centers (no-iOSCS group), whereas the remaining 1,532 patients (84.1%) were treated in iOSCS centers (iOSCS group).

Results

Patients of the no-iOSCS group had a higher perioperative risk defined by the logistic EuroSCORE (20.9% vs. 14.2%; p < 0.001) compared with patients treated in hospitals with iOSCS. Procedural survival was 96.9% in no-iOSCS centers and 98.6% in iOSCS centers (p = 0.034), whereas 30-day survival was 93.1% versus 96.0% (p = 0.039) and 1-year survival was 80.9% versus 86.1% (p = 0.017), respectively. After propensity score matching for confounders procedural survival was 96.9% versus 98.6% (p = 0.162), 93.1% versus 93.8% (p = 0.719) at 30 days, and 80.9% versus 83.4% (p = 0.402) at 1 year.

Conclusions

Patients undergoing transfemoral TAVR in hospitals without iOSCS had a significantly higher baseline risk profile. After propensity score matching short- and long-term mortality was similar between centers with and without iOSCS.





Transcatheter Aortic Valve Replacement Without On-Site Cardiac Surgery: A Disappointing Step Backward!




Multimarker Approach to Identify Patients With Higher Mortality and Rehospitalization Rate After Surgical Aortic Valve Replacement for Aortic Stenosis
AbstractObjectives

This study sought to evaluate whether a multimarker approach might identify patients with higher mortality and hospitalization rates after aortic valve replacement (AVR) for aortic stenosis (AS).

Background

The society valve guidelines include accepted triggers for AVR in patients with severe asymptomatic AS, but circulating biomarkers do not have a clear role.

Method

From a prospective registry of patients undergoing cardiac surgery between 2000 and 2012, 665 treated with surgical AVR (441 isolated) were evaluated. Seven biomarkers were measured on blood samples obtained before AVR. Biomarker levels were adjusted to account for the influence of age, sex, body mass index, and renal function; the median was used to determine an elevated value. Endpoints included all-cause mortality and all-cause and cardiovascular hospitalizations. Mean follow-up was 10.7 years and 299 (45%) died.

Results

Patients with 0 to 1, 2 to 3, 4 to 6, and 7 biomarkers elevated had 5-year mortality of 10%, 12%, 24%, and 33%, respectively, and 10-year mortality of 24%, 35%, 58%, and 71%, respectively (log-rank p < 0.001). The association between an increasing number of elevated biomarkers and increased all-cause mortality was observed among those with minimal symptoms (New York Heart Association functional class I or II) and those with a low N-terminal pro–B-type natriuretic peptide (p < 0.01 for both). Compared with those with 0 to 1 biomarkers elevated, patients with 4 to 6 or 7 biomarkers elevated had an increased hazard of mortality after adjustment for clinical risk scores (p < 0.01) and a 2- to 3-fold higher rate of all-cause and cardiovascular rehospitalization after AVR. Similar findings were obtained when evaluating cardiovascular mortality. Among patients with no or minimal symptoms, 42% had ≥4 biomarkers elevated.

Conclusions

Among patients with severe AS treated with surgical AVR, an increasing number of elevated biomarkers of cardiovascular stress was associated with higher all-cause and cardiovascular mortality and a higher rate of repeat hospitalization. A multimarker approach may be useful in the surveillance of asymptomatic patients with severe AS to optimize surgical timing.





A Stitch in Time: Biomarker-Guided Timing of Aortic Valve Replacement for Severe Aortic Stenosis?




Interaction Between Frailty and Access Site in Older Adults Undergoing Transcatheter Aortic Valve Replacement
AbstractObjectives

The authors sought to determine whether frail older adults undergoing nonfemoral transcatheter aortic valve replacement (TAVR) procedures had a higher risk of 30-day and 12-month mortality.

Background

Frailty can help predict outcomes and guide therapy in older adults being considered for TAVR. Nonfemoral TAVR procedures are more invasive and impart a greater risk of adverse events, which may be less well tolerated in frail patients, compared with transfemoral TAVR procedures.

Methods

This study was a post hoc analysis of the FRAILTY-AVR (Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions) prospective multicenter cohort that consisted of older adults undergoing TAVR from 2012 to 2017. Frailty was assessed using the Essential Frailty Toolset (EFT). Endpoints of interest were 30-day and 12-month all-cause mortality. Interaction tables and multivariable logistic regression models were used to investigate statistical interaction on the additive and multiplicative scales.

Results

The cohort consisted of 723 patients with a mean age of 84 ± 6 years, of which 556 (77%) had femoral access and 167 (23%) had nonfemoral access. In frail patients with EFT scores ≥3 (35%), nonfemoral access was associated with increased 30-day mortality (odds ratio [OR]: 3.91; 95% confidence interval [CI]: 1.48 to 10.31); whereas in nonfrail patients with EFT scores <3 (65%), nonfemoral access had no effect (OR: 1.29; 95% CI: 0.34 to 4.94). There was statistical evidence of interaction between frailty and access site on 30-day mortality on the additive scale (relative excess risk due to interaction = 5.95). Nonfemoral access was associated with increased 1-year mortality in frail patients (OR: 1.98; 95% CI: 1.00 to 3.93) but not in nonfrail patients (OR: 1.83; 95% CI: 0.90 to 3.74), although there was no statistical evidence of interaction.

Conclusions

Frail patients undergoing TAVR via a more invasive nonfemoral access face a substantially higher risk of 30-day mortality, whereas nonfrail older adults tolerate the procedure with a low short-term risk irrespective of access route.





Traveling Companions




Transcatheter Aortic Valve Replacement in the Catheterization Laboratory Versus Hybrid Operating Room: Insights From the FRANCE TAVI Registry
AbstractObjectives

This study sought to compare outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) in a catheterization laboratory (cath lab) to those undergoing TAVR in a hybrid operating room (OR).

Background

TAVR can be performed in a cath lab or in a hybrid OR. Comparisons between these locations are scarce.

Methods

All TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. The primary endpoint of this study was all-cause mortality at 1 year. Secondary endpoints consisted of 30-day complications and 3-year mortality. All analyses were adjusted for baseline and procedural characteristics.

Results

A total of 12,121 patients were included in this study, 62% of which underwent TAVR in a cath lab versus 38% in a hybrid OR. Mean age was 82.9 ± 7.2 years, 48.9% of patients were men, and mean Logistic EuroScore was 17.9% ± 12.3%. Both procedure locations showed similar, below 2% rates of intraprocedural complications. After adjusting for baseline and procedural characteristics, major bleeding and infections were significantly higher in the hybrid OR group (bleeding, 6.3% vs. 4.8%; infection, 6.1% vs. 3.5%; p < 0.05). Adjusted mortality rates at 1 and 3 years did not differ significantly between groups (for cath lab vs. hybrid OR, respectively: 1 year: 16.2% vs. 15.8%; p = 0.91; 3 years: 38.4% vs. 36.4%; p = 0.49).

Conclusions

Midterm mortality after TAVR was similar between the cath lab and the hybrid OR. These findings support the performance of TAVR in either location, which has important implications on health care organization and costs.





Hybrid Operating Rooms for Transcatheter Aortic Valve Replacement: A Must-Have or Nice to Have?




Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Prior Cardiac Surgery in the Randomized PARTNER 2A Trial
AbstractObjectives

The aim of this study was to further evaluate clinical outcomes in patients with and without PCS.

Background

Prior cardiac surgery (PCS) is associated with increased surgical risk and post-operative complications following surgical aortic valve replacement (SAVR), but whether this risk is similar in transcatheter aortic valve replacement (TAVR) is unclear.

Methods

In the PARTNER 2A (Placement of Aortic Transcatheter Valve) trial, 2,032 patients with severe aortic stenosis at intermediate surgical risk were randomized to TAVR with the SAPIEN XT valve or SAVR. Adverse clinical outcomes at 30 days and 2 years were compared using Kaplan-Meier event rates and multivariate Cox proportional hazards regression models. The primary endpoint of the PARTNER 2 trial was all-cause death and disabling stroke.

Results

Five hundred nine patients (25.1%) had PCS, mostly (98.2%) coronary artery bypass grafting. There were no significant differences between TAVR and SAVR in patients with or without PCS in the rates of the primary endpoint at 30 days or 2 years. Nevertheless, an interaction was observed between PCS and treatment arm; whereas no-PCS patients treated with TAVR had higher rates of 30-day major vascular complications than patients treated with SAVR (adjusted hazard ratio: 2.66; 95% confidence interval: 1.68 to 4.22), the opposite was true for patients with PCS (adjusted hazard ratio: 0.27; 95% confidence interval: 0.11 to 0.66) (pinteraction <0.0001). A similar interaction was observed for life-threatening or disabling bleeding.

Conclusions

In the PARTNER 2A trial of intermediate-risk patients with severe aortic stenosis undergoing SAVR versus TAVR, the relative risk for 2-year adverse clinical outcomes was similar between TAVR and SAVR in patients with or without PCS.





Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement: A Prior Sternotomy Is Not the Problem




The 21st Century Cures Act and Early Feasibility Studies for Cardiovascular Devices: What Have We Learned, Where Do We Need to Go?
Abstract

Performance of early feasibility studies in the United States can advance the goal of evaluating the safety and effectiveness of new devices aimed at unmet clinical needs and facilitating earlier access for U.S. patients to new technology. Early feasibility studies are an important component of the 21st Century Cures Act, enacted by Congress in 2016. Although regulatory processes have improved since the introduction of the Early Feasibility Studies Program, impediments at the hospital and clinical site level remain. In this paper, the authors review these issues and outline the structure and function of a clinical site consortium designed to address the problems and improve the U.S. clinical trial ecosystem.





Transcatheter Tricuspid Valve-in-Valve Replacement With Subsequent Bioprosthetic Valve Fracture to Optimize Hemodynamic Function




First-in-Human Percutaneous Left Atrial Appendage Occlusion Procedure Guided by Real-Time 3-Dimensional Intracardiac Echocardiography




The Power of Imaging: The Default Question Should Become When Should Intravascular Imaging Be Avoided?




Reply: The Power of Imaging: The Default Question Should Become When Should Intravascular Imaging Be Avoided?




Multiple Overlapping Stents Might Be a Promising Therapeutic Target for Coronary Artery Aneurysms




What Is the Value of Continuous Monitoring Post-Transcatheter Aortic Valve Replacement?




Reply: What Is the Value of Continuous Monitoring Post-Transcatheter Aortic Valve Replacement?




BI-SILICA During Transcatheter Aortic Valve Replacement for Noncalcific Aortic Insufficiency: Initial Human Experience




First Evaluation of Acute Left Ventricular Response to Off-Pump Transcatheter Mitral Valve Replacement in High-Risk Patients




Surgical Aortic Valve Replacement in the Transcatheter Aortic Valve Replacement Era: Implications for the Heart Team




Intracardiac Echocardiography in Structural Heart Disease Interventions
Abstract

Intracardiac echocardiography has historically been used to guide a limited number of transcatheter cardiac interventions. However, the tremendous advances in structural heart disease interventions in the last decade led to a growing interest in intracardiac echocardiography as a potential alternative to transesophageal echocardiography that mitigates the need for endotracheal intubation. Nonetheless, the scarcity of data, the imperfection of the current probes, and the limited experience among operators prevented a wider adoption of this technology. This review summarizes the contemporary relevant evidence and provides the structural interventionalist with an illustrative guide on the use of intracardiac echocardiography to guide various structural heart interventions.





Trends in Isolated Surgical Aortic Valve Replacement According to Hospital-Based Transcatheter Aortic Valve Replacement Volumes
AbstractObjectives

This study sought to evaluate the trends in isolated surgical aortic valve replacement (SAVR) procedures across hospitals with different transcatheter aortic valve replacement (TAVR) volumes among Medicare beneficiaries.

Background

The volume of TAVR has increased in the United States since its approval, now exceeding that of isolated SAVR.

Methods

Hospitalizations of adults (≥18 years of age) with International Classification of Diseases-9th Revision-Clinical Modification procedure codes for SAVR (35.21 or 35.22) or TAVR (35.05 or 35.06) who were included in the Medicare Provider Analysis and Review database between January 1, 2011, and December 31, 2014, were included. Trends in isolated SAVR patient characteristics, procedural volumes, and outcomes by quartile (Q) of hospital-level TAVR use were assessed over the study period.

Results

A total of 37,705 isolated SAVR procedures were analyzed for the study. The annual volume of isolated SAVR procedures decreased in hospitals performing the largest number of TAVR procedures (Q3: 1,557 in 2011 to 1,391 in 2014; and Q4: 2,607 in 2011 to 1,791 in 2014). Thirty-day and 1-year mortality after SAVR also declined over the study period in hospitals with the largest TAVR volume (annual change rate in mortality for Q3: –16.4%; p < 0.001; Q4: –20.8%; p < 0.001).

Conclusions

The advent of TAVR was associated with a reduction in isolated SAVR volumes, a decrease in comorbidities among patients undergoing SAVR, and corresponding reductions in observed short- and long-term SAVR mortality among hospitals performing the greatest number of TAVRs.





Differences in Guiding Catheter Positions According to Left and Right Radial Approaches




Software Modeling to Predict Paravalvular Leak Following Transcatheter Mitral Valve Replacement




Differential Diagnosis for an Intracaval Foreign Body




Coronary Hemodynamics in Patients With Severe Aortic Stenosis and Coronary Artery Disease Undergoing Transcatheter Aortic Valve Replacement: Implications for Clinical Indices of Coronary Stenosis Severity
AbstractObjectives

In this study, a systematic analysis was conducted of phasic intracoronary pressure and flow velocity in patients with severe aortic stenosis (AS) and coronary artery disease, undergoing transcatheter aortic valve replacement (TAVR), to determine how AS affects: 1) phasic coronary flow; 2) hyperemic coronary flow; and 3) the most common clinically used indices of coronary stenosis severity, instantaneous wave-free ratio and fractional flow reserve.

Background

A significant proportion of patients with severe aortic stenosis (AS) have concomitant coronary artery disease. The effect of the valve on coronary pressure, flow, and the established invasive clinical indices of stenosis severity have not been studied.

Methods

Twenty-eight patients (30 lesions, 50.0% men, mean age 82.1 ± 6.5 years) with severe AS and coronary artery disease were included. Intracoronary pressure and flow assessments were performed at rest and during hyperemia immediately before and after TAVR.

Results

Flow during the wave-free period of diastole did not change post-TAVR (29.78 ± 14.9 cm/s vs. 30.81 ± 19.6 cm/s; p = 0.64). Whole-cycle hyperemic flow increased significantly post-TAVR (33.44 ± 13.4 cm/s pre-TAVR vs. 40.33 ± 17.4 cm/s post-TAVR; p = 0.006); this was secondary to significant increases in systolic hyperemic flow post-TAVR (27.67 ± 12.1 cm/s pre-TAVR vs. 34.15 ± 17.5 cm/s post-TAVR; p = 0.02). Instantaneous wave-free ratio values did not change post-TAVR (0.88 ± 0.09 pre-TAVR vs. 0.88 ± 0.09 post-TAVR; p = 0.73), whereas fractional flow reserve decreased significantly post-TAVR (0.87 ± 0.08 pre-TAVR vs. 0.85 ± 0.09 post-TAVR; p = 0.001).

Conclusions

Systolic and hyperemic coronary flow increased significantly post-TAVR; consequently, hyperemic indices that include systole underestimated coronary stenosis severity in patients with severe AS. Flow during the wave-free period of diastole did not change post-TAVR, suggesting that indices calculated during this period are not vulnerable to the confounding effect of the stenotic aortic valve.





Instantaneous Wave-Free Ratio for the Assessment of Intermediate Coronary Artery Stenosis in Patients With Severe Aortic Valve Stenosis: Comparison With Myocardial Perfusion Scintigraphy
AbstractObjectives

This study investigated the diagnostic performance of instantaneous wave-free ratio (iFR) in patients with aortic valve stenosis (AS).

Background

The iFR was introduced as a new, nonpharmacologic stress index of coronary stenosis severity. However, the diagnostic performance of iFR has not been sufficiently explored in patients with severe AS.

Methods

We analyzed 95 consecutive patients with AS (57 women) demonstrating intermediate coronary artery stenosis (116 vessels), and compared the iFR values with fractional flow reserve (FFR) values and with adenosine-stress myocardial perfusion imaging as indicators of myocardial ischemia.

Results

The median value and interquartile range (first quartile [Q1], third quartile [Q3]) of the iFR was 0.86 (Q1 to Q3 range, 0.76 to 0.93), and that of the FFR was 0.84 (Q1 to Q3 range, 0.76 to 0.91). The iFR values correlated well with the FFR values (R = 0.854; p < 0.0001). A receiver operating characteristic analysis demonstrated an optimal cutoff of 0.82 for the iFR to indicate an FFR ≤0.75, with an area under the curve of 0.92. The optimal iFR cutoff value indicating myocardial ischemia on perfusion scintigraphy was 0.82 (area under the curve: 0.84).

Conclusions

In patients with severe AS, a good correlation exists between iFR and FFR. Both the iFR and FFR values exhibit good correlation with perfusion scintigraphy–identified myocardial ischemia. The iFR could be a safe diagnostic tool for patients with severe AS. (The Impact of FFR and iFR in Patients with Severe Aortic Stenosis; UMIN000024479)





The Interface Between Coronary Physiology and Severe Aortic Stenosis: Relax and Go With the Flow




Doppler Flow Velocity and Thermodilution to Assess Coronary Flow Reserve: A Head-to-Head Comparison With [15O]H2O PET
AbstractObjectives

This study sought to compare Doppler flow velocity reserve (CFRDoppl) and thermodilution-derived coronary flow reserve (CFRthermo) head-to-head with the gold standard for quantification of myocardial perfusion, [15O]H2O positron emission tomography (PET).

Background

Coronary flow reserve (CFR) is an important parameter for assessing coronary vascular function. To date, 2 techniques are available for invasive assessment of CFR: Doppler flow velocity and thermodilution. Although these techniques have been compared with each other, neither has been compared with [15O]H2O PET perfusion imaging.

Methods

CFR was assessed in 98 vessels of 40 consecutive stable patients with suspected coronary artery disease. Patients underwent [15O]H2O PET, followed by invasive angiography in conjunction with simultaneous measurements of fractional flow reserve, CFRDoppl, and CFRthermo. Both normal and obstructed arteries were included.

Results

The quality of Doppler flow velocity traces was significantly lower than that of thermodilution curves (p < 0.001). A moderate correlation was observed between CFRDoppl and CFRthermo (r = 0.59; p < 0.001). CFRDoppl correlated well with PET-derived CFR (CFRPET) (r = 0.82; p < 0.001). In contrast, the correlation between CFRthermo and CFRPET was only modest (r = 0.55; p < 0.001). This difference in correlation with CFRPET was significant (t = 4.9; df = 95; p < 0.001). Bland-Altman analysis revealed a tendency of CFRthermo to overestimate flow reserve at higher values.

Conclusions

Coronary flow reserve, determined using Doppler flow velocity, has superior agreement with [15O]H2O PET in comparison with CFRthermo.





The Challenges of Measuring Coronary Flow Reserve: Comparisons of Doppler and Thermodilution to [15O]H2O PET Perfusion




Optical Coherence Tomography-Defined Plaque Vulnerability in Relation to Functional Stenosis Severity and Microvascular Dysfunction
AbstractObjectives

This study sought to investigate the relationship of unstable plaque features with physiological lesion severity and microvascular dysfunction.

Background

The functional severity of epicardial lesions and microvascular dysfunction are both related to adverse clinical outcomes.

Methods

We investigated 382 de novo intermediate and severe coronary lesions in 340 patients who underwent optical coherence tomography, fractional flow reserve (FFR), and index of microcirculatory resistance (IMR) examinations. Lesions were divided into tertiles based on either FFR or IMR values. The optical coherence tomography findings were compared among the tertiles of FFR and IMR. Each tertile was defined as follows: FFR-T1 (FFR <0.74), FFR-T2 (0.74 ≤ FFR ≤0.81), and FFR-T3 (FFR >0.81); and IMR-T1 (IMR ≥25), IMR-T2 (15 < IMR <25), and IMR-T3 (IMR ≤15).

Results

No significant relationship was observed between FFR and IMR. The prevalence of optical coherence tomography–defined thin-cap fibroatheroma (TCFA) was significantly greater in IMR-T1 than in IMR-T2 and IMR-T3. An overall significant difference in the prevalence of TCFAs was detected among FFR tertiles, although no pairwise comparison revealed statistical significance. The prevalence of ruptured plaque was significantly greater in IMR-T1 than in IMR-T2 and IMR-T3, although no significant difference was observed between FFR tertiles. Multivariate analysis showed that FFR and IMR were independent predictors of the prevalence of TCFAs (odds ratio: 0.036; 95% confidence interval: 0.004 to 0342; p = 0.004; and odds ratio: 1.034; 95% confidence interval: 1.014 to 1.054; p = 0.001, respectively).

Conclusions

Lower FFR and higher IMR values were independent predictors of the presence of a TCFA in angiographically intermediate-to-severe stable lesions or nonculprit lesions in acute coronary syndrome.





Coronary Microvasculature: Are the Small and the Mighty Cross-Talking With the Epicardial Vessels?




Low Coronary Wall Shear Stress Is Associated With Severe Endothelial Dysfunction in Patients With Nonobstructive Coronary Artery Disease
AbstractObjectives

This study investigated the relationship between low wall shear stress (WSS) and severe endothelial dysfunction (EDFx).

Background

Local hemodynamic forces such as WSS play an important role in atherogenesis through their effect on endothelial cells. The study hypothesized that low WSS independently predicts severe EDFx in patients with coronary artery disease (CAD).

Methods

Forty-four patients with CAD underwent coronary angiography, fractional flow reserve, and endothelial function testing. Segments with >10% vasoconstriction after acetylcholine (Ach) infusion were defined as having severe EDFx. WSS, calculated using 3-dimensional angiography, velocity measurements, and computational fluid dynamics, was defined as low (<1 Pa), intermediate (1 to 2.5 Pa), or high (>2.5 Pa).

Results

Median age was 52 years, 73% were women. Mean fractional flow reserve was 0.94 ± 0.06. In 4,510 coronary segments, median WSS was 3.67 Pa. A total of 24% had severe EDFx. A higher proportion of segments with low WSS had severe EDFx (71%) compared with intermediate WSS (22%) or high WSS (23%) (p < 0.001). Segments with low WSS demonstrated greater vasoconstriction in response to Ach than did intermediate or high WSS segments (–10.7% vs. –2.5% vs. +1.3%, respectively; p < 0.001). In a multivariable logistic regression analysis, female sex (odds ratio [OR]: 2.44; p = 0.04), diabetes (OR: 5.01; p = 0.007), and low WSS (OR: 9.14; p < 0.001) were independent predictors of severe EDFx.

Conclusions

In patients with nonobstructive CAD, segments with low WSS demonstrated more vasoconstriction in response to Ach than did intermediate or high WSS segments. Low WSS was independently associated with severe EDFx.





"Doc, This Wall Stress Is Killing Me!": Another Way to Consider the Relation Between Stress and the Heart




Reclassification of Treatment Strategy With Instantaneous Wave-Free Ratio and Fractional Flow Reserve: A Substudy From the iFR-SWEDEHEART Trial
AbstractObjectives

The authors sought to compare reclassification of treatment strategy following instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR).

Background

iFR was noninferior to FFR in 2 large randomized controlled trials in guiding coronary revascularization. Reclassification of treatment strategy by FFR is well-studied, but similar reports on iFR are lacking.

Methods

The iFR-SWEDEHEART (Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome Trial) study randomized 2,037 participants with stable angina or acute coronary syndrome to treatment guided by iFR or FFR. Interventionalists entered the preferred treatment (optimal medical therapy [OMT], percutaneous coronary intervention [PCI], or coronary artery bypass grafting [CABG]) on the basis of coronary angiograms, and the final treatment decision was mandated by the iFR/FFR measurements.

Results

In the iFR/FFR (n = 1,009/n = 1,004) populations, angiogram-based treatment approaches were similar (p = 0.50) with respect to OMT (38%/35%), PCI of 1 (37%/39%), 2 (15%/16%), and 3 vessels (2%/2%) and CABG (8%/8%). iFR and FFR reclassified 40% and 41% of patients, respectively (p = 0.78). The majority of reclassifications were conversion of PCI to OMT in both the iFR/FFR groups (31.4%/29.0%). Reclassification increased with increasing number of lesions evaluated (odds ratio per evaluated lesion for FFR: 1.46 [95% confidence interval: 1.22 to 1.76] vs. iFR 1.37 [95% confidence interval: 1.18 to 1.59]). Reclassification rates for patients with 1, 2, and 3 assessed vessels were 36%, 52%, and 53% (p < 0.01).

Conclusions

Reclassification of treatment strategy of intermediate lesions was common and occurred in 40% of patients with iFR or FFR. The most frequent reclassification was conversion from PCI to OMT regardless of physiology modality. Irrespective of the physiological index reclassification of angiogram-based treatment strategy increased with the number of lesions evaluated.





Reclassification of Treatment Strategy by Routine Coronary Pressure Assessment--Episode 7 of the Saga: The More You Look, the More You Find It!




Prognostic Implications of Relative Increase and Final Fractional Flow Reserve in Patients With Stent Implantation
AbstractObjectives

The study sought to investigate the prognostic implications of relative increase of fractional flow reserve (FFR) with PCI in combination with post–percutaneous coronary intervention (PCI) FFR.

Background

FFR, measured after PCI has been shown to possess prognostic implications. The relative increase of FFR with PCI can be determined by the interaction of baseline disease pattern, adequacy of PCI, and residual disease burden in a target vessel. However, the role of relative increase of FFR with PCI has not yet been evaluated.

Methods

A total of 621 patients who underwent PCI using second-generation drug-eluting stents based on low pre-PCI FFR (≤0.80) and available post-PCI FFR were analyzed. The relative increase of FFR was calculated by %FFR increase with PCI ([post-PCI FFR – pre-PCI FFR]/pre-PCI FFR x 100). Patients were divided according to the optimal cutoff values of post-PCI FFR (<0.84) and %FFR increase (≤15%). The primary outcome was target vessel failure (TVF) (a composite of cardiac death, target vessel–related myocardial infarction, and clinically driven target vessel revascularization) at 2 years.

Results

Among the total population, 66.0% showed high post-PCI FFR (≥0.84) and 69.2% showed high %FFR increase (>15%). Patients with low post-PCI FFR showed a higher risk of 2-year TVF than did those with high post-PCI FFR (9.1% vs. 2.6%; hazard ratio [HR]: 3.367; 95% confidence interval [CI]: 1.412 to 8.025; p = 0.006). Patients with low %FFR increase also showed a higher risk of 2-year TVF compared with those with high %FFR increase (9.2% vs. 3.0%; HR: 3.613; 95% CI: 1.543 to 8.458; p = 0.003). Among the high post-PCI FFR group, there were no significant differences in clinical outcomes according to %FFR increase. Conversely, among the low post-PCI FFR group, those with low %FFR increase showed a significantly higher risk of TVF than did those with high %FFR increase (14.3% vs. 4.1%; HR: 4.334; 95% CI: 1.205 to 15.594; p = 0.025). Percent FFR increase significantly increased discriminant and reclassification ability for the occurrence of TVF when added to a model with clinical risk factors and post-PCI FFR (C-index 0.783 vs. 0.734; relative integrated discrimination improvement 0.702; p = 0.009; category-free net reclassification index 0.479; p = 0.031).

Conclusions

Percent FFR increase with PCI showed similar prognostic implications with post-PCI FFR. Adding the relative increase of FFR to post-PCI FFR would enable better discrimination of high-risk patients after stent implantation. (Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention [PERSPECTIVE]; NCT01873560)





Predicting Outcomes After Percutaneous Coronary Intervention Using Relative Change in Fractional Flow Reserve




Anatomic Basis and Physiological Rationale of Distal Radial Artery Access for Percutaneous Coronary and Endovascular Procedures
Abstract

Transradial access offers important advantages over transfemoral access, including overall increased procedure comfort and better outcomes. Still, complications of transradial access exist, with radial artery occlusion being the most clinically relevant one. Puncture sites in the hand allowing distal radial artery access have initially been described for anterograde angioplasty of occluded radial arteries and could represent a valuable alternative to traditional wrist puncture for radial artery catheterization. What may at first appear as a "radialist eccentricity" definitely has a sound rationale, which the authors review. Knowledge of the anatomic and physiological principles at the basis of distal radial artery access is essential to promote rigorous understanding and practice of this new opportunity for both patients and interventional specialists.





Have I Lost My Goggles in the Optical Coherence Tomography Pullback!?: A Very Unusual Finding in Coronary Optical Coherence Tomography




Lipid Plaque Modification During Resorption of Absorb Bioresorbable Scaffold: Insights From Optical Coherence Tomography




Intracoronary Bolus Injection Versus Intravenous Infusion of Adenosine for Assessment of Coronary Flow Velocity Reserve in Women With Signs and Symptoms of Myocardial Ischemia and No Obstructive Coronary Artery Disease




Sex-Based Differences in Outcomes of Coronary Stenting With Unprotected Left Main Disease




Physical Activity and Noninvasive Cardiac Output as Novel Clinical Endpoints After Transcatheter Valve Repair for Severe Tricuspid Regurgitation




Being a Great Reviewer: Remembering the "Why"




Double Anomalous Aortic Origin of a Coronary Artery With Intramural Course




Histopathologic Insights Into the Honeycomb-Like Structure in the Coronary Artery: In Vivo Multimodality Imaging Assessment With Directional Coronary Atherectomy




Transcatheter Aortic Valve Replacement for Bioprosthetic Aortic Stenosis in Pregnancy




Septal Collateralization to Right Coronary Artery in Alcohol Septal Ablation: Solution to a Dangerous Pitfall




Better Understanding of Tricuspid Regurgitation Induced by Implanted Leads




Reply: Better Understanding of Tricuspid Regurgitation Induced by Implanted Leads




LAMPOON to Facilitate Tendyne Transcatheter Mitral Valve Replacement




Quality-of-Life Assessment in the EXCEL Trial




Morphological and Biomechanical Consequences of Post-Dilatation Following Transcatheter Aortic Valve Replacement: A Pilot Study




Very Long Term Follow-Up After Percutaneous Balloon Mitral Valvuloplasty
AbstractObjectives

The aim of this study was to assess very long term outcomes after successful percutaneous balloon mitral valvuloplasty (PBMV).

Background

PBMV remains the preferred treatment for patients with severe symptomatic rheumatic mitral stenosis and suitable anatomy.

Methods

All consecutive patients who underwent successful PBMV between 1987 and 2010 were included. The primary endpoint was the composite of all-cause mortality, need for mitral surgery, or repeat PBMV up to 23 years.

Results

Among all 1,582 consecutive patients undergoing PBMV, acute success was achieved in 90.9% (n = 1,438). Independent predictors of acute success included left atrial size (odds ratio: 0.96; 95% confidence interval [CI]: 0.93 to 0.99; p = 0.045), Wilkins score ≤8 (odds ratio: 1.66; 95% CI: 0.48 to 0.93; p = 0.02) and age (odds ratio: 0.97; 95% CI: 0.96 to 0.99; p = 0.006). Very long term follow-up (median 8.3 years, mean 15.6 years) was obtained in 79.1% of successful cases. The incidence of the primary endpoint was 19.1% (95% CI: 17.0% to 21.1%). The rates of overall mortality, need for mitral valve surgery, or repeat PBMV were 0.6% (95% CI: 0.3% to 1.2%), 8.3% (95% CI: 7.0% to 9.9%), and 10.0% (95% CI: 8.5% to 11.7%), respectively. On multivariate analysis, New York Heart Association functional class III or IV (hazard ratio: 1.62; 95% CI: 1.26 to 2.09; p < 0.001), higher age (hazard ratio: 0.97; 95% CI: 0.96 to 0.98; p = 0.028), and mitral valve area ≤1.75 cm2 after the procedure (hazard ratio: 1.67; 95% CI: 1.28 to 2.11; p = 0.028) were independent predictors of the primary endpoint.

Conclusions

In very long term follow-up, more than 75% of patients exhibited sustained results. Prediction of late favorable results is multifactorial and strongly determined by age, previous symptoms and post-procedural mitral valve area.





The "Very" Long and Short of It: Follow-Up of Balloon Mitral Valvuloplasty in a Select Population




Impact of Direct Transcatheter Aortic Valve Replacement Without Balloon Aortic Valvuloplasty on Procedural and Clinical Outcomes: Insights From the FRANCE TAVI Registry
AbstractObjectives

This study sought to describe the current practices and compare outcomes according to the use of balloon aortic valvuloplasty (BAV) or not during transcatheter aortic valve replacement (TAVR).

Background

Since its development, aortic valve pre-dilatation has been an essential step of TAVR procedures. However, the feasibility of TAVR without systematic BAV has been described.

Methods

TAVR performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (Registry of Aortic Valve Bioprostheses Established by Catheter) registry. We compared outcomes according to BAV during the TAVR procedure.

Results

A total of 5,784 patients have been included in our analysis, corresponding to 2,579 (44.6%) with BAV avoidance and 3,205 (55.4%) patients with BAV performed. We observed a progressive decline in the use of BAV over time (78% of procedures in 2013 and 49% in the last trimester of 2015). Avoidance of BAV was associated with similar device implantation success (97.3% vs. 97.6%; p = 0.40). TAVR procedures without BAV were quicker (fluoroscopy 17.2 ± 9.1 vs. 18.5 ± 8.8 min; p < 0.01) and used lower amounts of contrast (131.5 ± 61.6 vs. 141.6 ± 61.5; p < 0.01) and radiation (608.9 ± 576.3 vs. 667.0 ± 631.3; p < 0.01). The rates of moderate to severe aortic regurgitation were lower with avoidance of BAV (8.3% vs. 12.2%; p < 0.01) and tamponade rates (1.5% vs. 2.3%; p = 0.04).

Conclusions

We confirmed that TAVR without BAV is frequently performed in France with good procedural results. This procedure is associated with procedural simplification and lower rates of residual aortic regurgitation.





Balloon Valvuloplasty Before Transcatheter Aortic Valve Replacement: Is It Now Optional?




1-Year Clinical Outcomes of All-Comer Patients Treated With the Dual-Therapy COMBO Stent: Primary Results of the COMBO Collaboration
AbstractObjectives

The aim of this study was to evaluate 1-year clinical safety and efficacy of the dual-therapy COMBO stent in a large, all-comers patient-level pooled cohort.

Background

The COMBO stent (OrbusNeich Medical, Fort Lauderdale, Florida) is a novel stent with abluminal sirolimus elution from a biodegradable polymer and a luminal pro-healing anti-CD34+ antibody layer, which attracts circulating endothelial progenitor cells. These endothelial progenitor cells can quickly mature into normal endothelium, providing rapid endothelialization.

Methods

The MASCOT (Multinational Abluminal Sirolimus Coated biO-engineered stenT) (N = 2,614, 61 global sites) and REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt Post Market Registry) (N = 1,000, 9 European sites) registries are 2 prospective, multicenter studies evaluating clinical outcomes after attempted COMBO stent placement in all-comer patients undergoing percutaneous coronary intervention. In this patient-level pooled analysis we analyzed 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Furthermore, we determined predictors of 1-year TLF.

Results

A total of 3,614 patients (63.5 ± 11.2 years of age; 23.8% women) were included in this analysis. The prevalence of diabetes mellitus was 29.3%, and 54.3% patients presented with acute coronary syndrome. The primary endpoint of 1-year TLF occurred in 140 (3.9%) patients, with incidence of cardiac death in 1.6%, target vessel myocardial infarction in 1.2%, clinically driven target lesion revascularization in 2.2%, and definite stent thrombosis in 0.5% patients. Insulin-treated diabetes mellitus, chronic renal failure, and American College of Cardiology/American Heart Association lesion type B2/C were independent predictors of 1-year TLF.

Conclusions

In this large patient-level pooled analysis of patients treated with the dual-therapy COMBO stent excellent results at 1-year were observed. (MASCOT - Post Marketing Registry [MASCOT]; NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the COMBO Stent [REMEDEE Reg]; NCT01874002)





Have We Found the Right COMBO to Balance Vascular Injury and Healing?




A Randomized Trial to Assess Regional Left Ventricular Function After Stent Implantation in Chronic Total Occlusion: The REVASC Trial
AbstractObjectives

The aim of this study was to investigate whether percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) improves left ventricular function.

Background

The benefit of PCI in CTOs is still controversial.

Methods

Patients with CTOs who were candidates for PCI were eligible for the study and were randomized to PCI or no PCI of CTO. Relevant coexisting non-CTO lesions were treated as indicated. Patients underwent cardiac magnetic resonance imaging at baseline and at 6 months. The primary endpoint was the change in segmental wall thickening (SWT) in the CTO territory. Secondary endpoints were improvement of regional wall motion and changes in left ventricular volumes and ejection fraction. Furthermore, major adverse coronary events after 12 months were assessed.

Results

The CTO PCI group comprised 101 patients and the no CTO PCI group 104 patients. The change in SWT did not differ between the CTO PCI (4.1% [interquartile range: 14.6 to 19.3]) and no CTO PCI (6.0% [interquartile range: 8.6 to 6.0]) groups (p = 0.57). Similar results were obtained for other indexes of regional and global left ventricular function. Subgroup analysis revealed that only in patients without major non-CTO lesions (basal SYNTAX [Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery] score ≤13) CTO PCI was associated with larger improvement in SWT than no CTO PCI (p for interaction = 0.002). Driven by repeat intervention, major adverse coronary event rates at 12 months were significantly lower in the CTO PCI group (16.3% vs. 5.9%; p = 0.02).

Conclusions

No benefit was seen for CTO PCI in terms of the primary endpoint, SWT, or other indexes of left ventricular function. CTO PCI resulted in clinical benefit over no CTO PCI, as evidenced by reduced major adverse coronary event rates at 12 months.





Chronic Total Occlusion Intervention: The Case for More Evidence




WIRION Embolic Protection System in Lower Extremity Arterial Interventions: Results of the Pivotal WISE LE Trial
AbstractObjectives

The WISE LE (WIRION™ EPS in Lower Extremities Arteries) study was designed to assess the clinical performance of the WIRION Embolic Protection System (EPS) in subjects undergoing lower extremity atherectomy for the treatment of peripheral artery disease.

Background

Embolization is ubiquitous during endovascular procedures for lower extremity peripheral artery disease.

Methods

The WISE LE was a multicenter study, performed in the United States and Germany. The primary endpoint was freedom from major adverse events (MAEs) occurring within 30 days post-procedure and was compared with an objective performance goal derived from historical atherectomy trials. MAE was defined as a serious adverse event that resulted in death, acute myocardial infarction, thrombosis, pseudoaneurysm, dissection (grade C or greater), or clinical perforation at the filter location, clinically relevant distal embolism, unplanned amputation, or clinically driven target vessel revascularization. The study also included a histopathological analysis of debris captured by the filter during the procedures.

Results

The study protocol specified enrollment of 153 patients with the primary endpoint successfully met if 18 (12.0%) or fewer MAEs occurred. A pre-specified interim analysis performed after 103 patients revealed only 2 MAEs, and the study was stopped because it had met its pre-determined metric for success. Lesion deemed not accessible by the WIRION EPS occurred in 7 patients. Debris of <1-mm, 1- to 2-mm, and >2-mm diameter were found in 98%, 22%, and 9% of patients, respectively.

Conclusions

The WIRION EPS is safe and noninferior to the pre-specified performance goal in capturing debris in the vast majority of patients and with the use of a broad range of atherectomy systems.





Performance Goal Criteria for Device Evaluation in Lower Extremity Peripheral Vascular Intervention and the Need for Standardized Data Structure: What Is the Sound of One Hand Clapping?




The Rare Complication of Transcatheter Mitral Valve-in-Ring Procedure: Not Only Left Ventricular Outflow Tract Obstruction Counts




Edwards SAPIEN Transcatheter Pulmonary Valve Implantation: Results From a French Registry
AbstractObjectives

The aim of this study was to describe and analyze data from patients treated in France with the Edwards SAPIEN transcatheter heart valve (Edwards Lifesciences LLC, Irvine, California) in the pulmonary position.

Background

The Edwards SAPIEN valve has recently been introduced for percutaneous pulmonary valve implantation (PPVI).

Methods

From April 2011 to May 2017, 71 patients undergoing PPVI were consecutively included.

Results

The median age at PPVI was 26.8 years (range 12.8 to 70.1 years). Primary underlying diagnoses were conotruncal malformations (common arterial trunk, tetralogy of Fallot and variants; n = 45), Ross procedure (n = 18), and other diagnoses (n = 8). PPVI indication was pure stenosis in 33.8% of patients, pure regurgitation in 28.1%, and mixed lesions in 38.1%. PPVI was successfully implemented in 68 patients (95.8%). Pre-stenting of the right ventricular outflow tract was performed in 70 patients (98.6%). Early major complications occurred in 4 subjects (5.6%), including 1 death, 1 coronary compression, and 2 pulmonary valve embolizations. Three of the 4 major complications occurred in the first 15 operated patients. No significant regurgitation was recorded after the procedure. Transpulmonary gradient was significantly reduced from 34.5 to 10.5 mm Hg (p < 0.0001). No patient died during a 1-month follow-up period. At 1-year follow-up, the death rate was 2.9%, and 3 patients had undergone surgical reintervention (44%).

Conclusions

Early results with the Edwards SAPIEN valve in the pulmonary position demonstrate an ongoing high rate of procedural success.





The Edwards SAPIEN Valve in the Pulmonic Position: The Not-So-New Kid on the Block




3-Year Outcomes of the Edwards SAPIEN Transcatheter Heart Valve for Conduit Failure in the Pulmonary Position From the COMPASSION Multicenter Clinical Trial
AbstractObjectives

This study provides the 3-year follow-up results of the COMPASSION (Congenital Multicenter Trial of Pulmonic Valve Regurgitation Studying the SAPIEN Transcatheter Heart Valve) trial. Patients with moderate to severe pulmonary regurgitation and/or right ventricular outflow tract conduit obstruction were implanted with the SAPIEN transcatheter heart valve (THV).

Background

Early safety and efficacy of the Edwards SAPIEN THV in the pulmonary position have been established through a multicenter clinical trial.

Methods

Eligible patients were included if body weight was >35 kg and in situ conduit diameter was ≥16 and ≤24 mm. Adverse events were adjudicated by an independent clinical events committee. Three-year clinical and echocardiographic outcomes were evaluated in these patients.

Results

Fifty-seven of the 63 eligible patients were accounted for at the 3-year follow-up visit from a total of 69 implantations in 81 enrolled patients. THV implantation was indicated for pulmonary stenosis (7.6%), regurgitation (12.7%), or both (79.7%). Twenty-two patients (27.8%) underwent implantation of 26-mm valves, and 47 patients received 23-mm valves. Functional improvement in New York Heart Association functional class was observed in 93.5% of patients. Mean peak conduit gradient decreased from 37.5 ± 25.4 to 17.8 ± 12.4 mm Hg (p < 0.001), and mean right ventricular systolic pressure decreased from 59.6 ± 17.7 to 42.9 ± 13.4 mm Hg (p < 0.001). Pulmonary regurgitation was mild or less in 91.1% of patients. Freedom from all-cause mortality at 3 years was 98.4%. Freedom from reintervention was 93.7% and from endocarditis was 97.1% at 3 years. There were no observed stent fractures.

Conclusions

Transcatheter pulmonary valve replacement using the Edwards SAPIEN THV demonstrates excellent valve function and clinical outcomes at 3-year follow-up.





Is It Wise to Implant a SAPIEN Transcatheter Heart Valve in a Dysfunctional Right Ventricular Outflow Tract?




Percutaneous Left Atrial Appendage Closure With the Ultraseal Device: Insights From the Initial Multicenter Experience
AbstractObjectives

This study sought to evaluate the feasibility, safety, and efficacy of the Ultraseal device for left atrial appendage closure (LAAC) (Cardia, Eagan, Minnesota) in patients with nonvalvular atrial fibrillation at high bleeding risk.

Background

The Ultraseal device is a novel bulb-and-sail designed LAAC device, with an articulating joint enabling conformability to heterogeneous angles and shapes of appendage anatomy.

Methods

This was a multicenter study including consecutive patients undergoing LAAC with the Ultraseal device at 15 Canadian and European sites. Periprocedural and follow-up events were systematically collected, and transesophageal echocardiography at 45 to 180 days post-procedure was routinely performed in all centers but 3.

Results

A total of 126 patients (mean age 75 ± 8 years; mean CHA2DS2-VASc score 5 ± 2; mean HAS-BLED score 4 ± 1) were included. The device was successfully implanted in 97% of patients. A major periprocedural adverse event occurred in 3 (2.4%) patients (clinically relevant pericardial effusion [n = 1], stroke [n = 1], device embolization [n = 1]). Ninety percent of patients were discharged on single or dual antiplatelet therapy. Follow-up transesophageal echocardiography was available in 89 (73%) patients, with no cases of large (>5 mm) residual leak and 5 (5.6%) cases of device-related thrombosis (all successfully treated with anticoagulation therapy). At a median follow-up of 6 (interquartile range: 3 to 10) months, the rates of stroke and transient ischemic attack were 0.8% and 0.8%, respectively, with no systemic emboli. None of the events occurred in patients with device-related thrombosis.

Conclusions

In this initial multicenter experience, LAAC with the Ultraseal device was associated with a high implant success rate and a very low incidence of periprocedural complications. There were no late device-related clinical events and promising efficacy results were observed regarding thromboembolic prevention at midterm follow-up. Larger studies are further warranted to confirm the long-term safety and efficacy of this novel device.





Why Do We Need Yet Another Left Atrial Appendage Occluder Device?




Life-Threatening Acute Occlusion of the Left Main Coronary Artery With Massive Thrombi Originating in the Left Atrial Appendage




Acute Myocardial Infarction Due to Prolapse of Covered Stent Into Coronary Artery Aneurysm




ST-Segment Elevation Myocardial Infarction Due to Optical Coherence Tomography-Detected Coronary Artery Compression Following Supravalvular Pulmonary Artery Patchplasty 18 Years After Switch Procedure




A Practical Approach to the Management of Complications During Percutaneous Coronary Intervention
Abstract

Percutaneous coronary intervention relieves symptoms in patients with chronic ischemic heart disease resistant to optimal medical therapy and alters the natural history of acute coronary syndromes. However, adverse procedural outcomes may occur during the intervention. Knowledge of possible complications and their timely management are essential for the practicing cardiologist and can be life-saving for the patient. In this review, the authors summarize potential complications of percutaneous coronary intervention focusing on their practical management.





Mortality in Patients With Out-of-Hospital Cardiac Arrest Undergoing a Standardized Protocol Including Therapeutic Hypothermia and Routine Coronary Angiography: Experience From the HACORE Registry
AbstractObjectives

This study sought to analyze the impact of mandatory therapeutic hypothermia and cardiac catheterization in the absence of overt noncardiac cause of arrest as part of the Hannover Cardiac Resuscitation Algorithm before intensive care admission.

Background

Despite advanced therapies, out-of-hospital cardiac arrest (OHCA) is still associated with high mortality rates. Recently, the TTM (Target Temperature Management 33°C Versus 36°C After Out-of-Hospital Cardiac Arrest)-trial caused severe uncertainty about the efficacy of and need for therapeutic hypothermia. Furthermore, the role of early coronary angiography in OHCA survivors without ST-segment elevation remains undetermined.

Methods

In the HACORE (HAnnover Cooling REgistry) we investigated 233 consecutive patients (median age 64 [interquartile range: 53 to 74] years) with OHCA admitted to our institution between January 2011 and December 2015 who were treated according to the algorithm.

Results

A total of 73% had ventricular fibrillation as primary rhythm. Return of spontaneous circulation was achieved after 20 (interquartile range: 10 to 30) min. Immediate percutaneous coronary angiography was performed in 96% and coronary angioplasty in 59% of all cases. ST-segment elevation was present in 47%. Critical coronary stenosis requiring percutaneous coronary intervention was present in 67% of patients with and 52% of patients without ST-segment elevation. Overall 30-day intrahospital mortality in this real-world registry was 37%. Patients in our local registry who matched the inclusion/exclusion criteria of the TTM-trial (n = 145) had a markedly lower 30-day mortality (27%) compared with the published trial (44%).

Conclusions

Standardized treatment of patients with OHCA following a strict protocol incorporating computed tomography, cardiac catheterization and revascularization, liberal use of active hemodynamic support in presence of shock, and mandatory therapeutic hypothermia results in mortality rates lower than previously reported.





Further Refinements to a System of Care for Out-of-Hospital Cardiac Arrest Bring Substantial Benefit: A Call to Action




Delays in Primary Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction Patients Presenting With Cardiogenic Shock
AbstractObjectives

This study sought to examine whether quality improvement initiatives across multiple ST-segment elevation myocardial infarction (STEMI) systems translated to faster first medical contact (FMC)-to-device times for patients presenting with cardiogenic shock (CS).

Background

There are limited data describing contemporary rates of achieving guideline-directed FMC-to-device times for STEMI patients with CS.

Methods

From 2012 to 2014, the American Heart Association Mission: Lifeline STEMI Systems Accelerator project established a protocol-guided approach to STEMI reperfusion systems in 484 U.S. hospitals. The study was stratified by CS versus no CS at presentation and performed Cochrane-Armitage tests to evaluate trends of achieving FMC-to-device time targets. A multivariable logistic regression model assessed the association between achieving guideline-directed FMC-to-device times and mortality.

Results

Among 23,785 STEMI patients, 1,993 (8.4%) experienced CS at presentation. For direct presenters, patients with CS were less likely to achieve the 90-min FMC-to-device time compared with no-CS patients (37% vs. 54%; p < 0.001). For transferred patients, CS patients were even less likely to reach the 120-min FMC-to-device time compared with no-CS patients (34% vs. 47%; p < 0.0001). The Accelerator intervention did not result in improvements in the FMC-to-device times for direct-presenting CS patients (p for trend = 0.53), although there was an improvement for transferred patients (p for trend = 0.04). Direct-presenting patients arriving within 90 min had lower mortality rates compared with patients who reached after 90 min (20.49% vs. 39.12%; p < 0.001).

Conclusions

Fewer than 40% of STEMI patients presenting with CS achieved guideline-directed FMC-to-device targets; delays in reperfusion for direct-presenting patients were associated with higher mortality.





Systems for Rapid Revascularization in ST-Segment Elevation Myocardial Infarction With Cardiogenic Shock: An Important Yet Elusive Goal




Association Between Cardiac Catheterization Laboratory Pre-Activation and Reperfusion Timing Metrics and Outcomes in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: A Report From the ACTION Registry
AbstractObjectives

The aim of this study was to describe the prevalence of pre-hospital cardiac catheterization laboratory activation and its association with reperfusion timeliness and in-hospital mortality.

Background

For patients with ST-segment elevation myocardial infarction diagnosed in the field, catheterization laboratory pre-activation may lead to more timely reperfusion and improved outcomes.

Methods

A total of 27,840 patients with ST-segment elevation myocardial infarction transported via emergency medical services to 744 percutaneous coronary intervention–capable hospitals in the ACTION Registry from January 2015 to March 2017 were evaluated, excluding patients with cardiac arrest or requiring pre–percutaneous coronary intervention intubation. Catheterization laboratory pre-activation was defined as activation >10 min prior to hospital arrival.

Results

Catheterization laboratory pre-activation occurred in 41% of patients (n = 11,379), with minor presenting differences between those with and without catheterization laboratory pre-activation. Compared with no catheterization laboratory pre-activation, pre-activation patients were more likely to be directly transported to the catheterization laboratory on hospital arrival (23.3% vs. 5.3%), to have shorter hospital arrival–to–catheterization laboratory arrival time (median 17 min [interquartile range (IQR): 7 to 25 min] vs. 28 min [IQR: 18 to 39 min]), to have shorter door-to-device time (40 min [IQR: 30 to 51 min] vs. 52 min [IQR: 41 to 65 min]), and to have a greater likelihood of achieving first medical contact–to–device time ≤90 min (76.6% vs. 68.6%) (p < 0.001 for all). Pre-activation was associated with lower in-hospital mortality (2.8% vs. 3.4%; p = 0.01). Patients treated at hospitals in the lowest tertile of pre-activation rates had higher mortality than those treated at hospitals in the highest tertile before and after adjustment (3.6% vs. 2.7%; adjusted odds ratio: 1.33; 95% confidence interval: 1.08 to 1.63).

Conclusions

In the United States, catheterization laboratory pre-activation occurred in fewer than one-half of emergency medical services–transported patients with ST-segment elevation myocardial infarction. Its association with faster reperfusion and lower mortality supports greater use of this strategy.





Fractional Flow Reserve and Instantaneous Wave-Free Ratio for Nonculprit Stenosis in Patients With Acute Myocardial Infarction
AbstractObjectives

The aim of this study was to compare the changes of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) with severity of epicardial coronary stenosis between nonculprit vessel of acute myocardial infarction (AMI) and stable ischemic heart disease (SIHD).

Background

There has been debate regarding the reliability of FFR or iFR for nonculprit stenosis in the acute stage of AMI.

Methods

A total of 100 AMI patients underwent comprehensive physiologic assessment including FFR, iFR, coronary flow reserve (CFR), and index of microcirculatory resistance (IMR) for nonculprit vessel stenosis after primary percutaneous coronary intervention (PCI) for culprit vessel. The changes in FFR and iFR for diameter stenosis (%DS) of nonculprit vessel stenosis were compared with FFR and iFR measured in 203 patients with SIHD.

Results

From 40% to 80% stenosis, FFR and iFR measured in nonculprit vessel of AMI patient showed significant decrease with worsening stenosis severity (all p values < 0.001). Nonculprit vessels of AMI patients showed lower CFR than SIHD; however, IMR was not different between the nonculprit vessel of AMI and SIHD patients. FFR and iFR were not significantly different between the nonculprit vessel of AMI and SIHD patients in all %DS groups from 40% to 80% (all p values > 0.05). In addition, percent difference of FFR and iFR according to the increase in %DS was also not significantly different between nonculprit vessel of AMI or SIHD. There was no significant interaction between clinical presentation and the changes of FFR and iFR for worsening %DS (interaction p value = 0.698 and 0.257, respectively).

Conclusions

Changes in FFR and iFR for the nonculprit stenosis of AMI patients were not significantly different from those in SIHD patients. These data support the use of invasive physiological parameters to guide treatment of nonculprit stenoses in the acute stage of successfully revascularized AMI.





Coronary Physiology in the Nonculprit Vessel After Acute Myocardial Infarction: To Go With the Flow or Unexpected Resistance?




Impact of Chronic Thrombocytopenia on In-Hospital Outcomes After Percutaneous Coronary Intervention
AbstractObjectives

This study sought to evaluate the impact of chronic thrombocytopenia (cTCP) on clinical outcomes after percutaneous coronary intervention (PCI).

Background

The impact of cTCP on clinical outcomes after PCI is not well described. Results from single-center observational studies and subgroup analysis of randomized trials have been conflicting and these patients are either excluded or under-represented in randomized controlled trials.

Methods

Using the 2012 to 2014 National (Nationwide) Inpatient Sample database, the study identified patients who underwent PCI with or without cTCP as a chronic condition variable indicator. Propensity score matching was performed using logistic regression to control for differences in baseline characteristics. The primary outcome of interest was in-hospital mortality. Secondary outcomes of interest included in-hospital post-PCI bleeding events, post-PCI blood and platelet transfusion, vascular complications, ischemic cerebrovascular accidents (CVAs), hemorrhagic CVAs, and length of stay.

Results

Propensity matching yielded a cohort of 65,130 patients (32,565 with and without cTCP). Compared with those without cTCP, PCI in patients with cTCP was associated with higher risk for bleeding complications (odds ratio [OR]: 2.40; 95% confidence interval [CI]: 2.05 to 2.72; p < 0.0001), requiring blood transfusion (OR: 2.10; 95% CI: 1.80 to 2.24; p < 0.0001), requiring platelet transfusion (OR: 11.70; 95% CI: 6.00 to 22.60; p < 0.0001), higher risk for vascular complications (OR: 1.94; 95% CI: 1.43 to 2.63; p < 0.0001), ischemic CVA (OR: 1.60; 95% CI: 1.20 to 2.10; p = 0.01), and higher in-hospital mortality (OR: 2.30; 95% CI: 1.90 to 2.70; p < 0.0001), but without a significant difference in hemorrhagic CVA (OR: 1.50; 95% CI: 0.70 to 3.10; p = 0.27).

Conclusions

In this large contemporary cohort, patients with cTCP were at higher risk of a multitude of complications, including higher risk of in-hospital mortality.





Chronic Thrombocytopenia and Percutaneous Coronary Intervention: The Virtue of Prudence




Temporal Trends and Outcomes of Percutaneous Coronary Interventions in Nonagenarians: A National Perspective
AbstractObjectives

This study sought to assess temporal trends and outcomes of percutaneous coronary intervention (PCI) in nonagenarians.

Background

With increasing life expectancy, nonagenarians requiring PCI are increasing even though outcomes data are limited.

Methods

The National Inpatient Sample was used to identify all hospitalizations for PCI in patients aged ≥90 years from January 1, 2003, to December 31, 2014. The primary outcome was in-hospital mortality.

Results

Nonagenarians (n = 69,271) constituted 0.9% of all PCI hospitalizations, increasing from 0.6% in 2003 to 2004 to 1.4% in 2013 to 2014 (ptrend < 0.001). From 2003–2004 to 2013–2014, the proportion of PCIs performed for ST-segment elevation myocardial infarction (STEMI) (23.1% to 30.9%) and non-ST-segment elevation acute coronary syndromes (49.6% to 52.6%) increased, whereas those for stable ischemic heart disease (SIHD) decreased (27.3% to 16.5%), respectively (ptrend < 0.001 for all). Overall in-hospital mortality after PCI for STEMI, non-ST-segment elevation acute coronary syndromes, and SIHD were 16.4%, 4.2%, and 1.8%, respectively. After multivariable risk adjustment for demographics, comorbidities, and hospital-level characteristics, in-hospital mortality remained unchanged in STEMI (odds ratio: 1.04; 95% confidence interval: 0.98 to 1.11; ptrend = 0.20) and non-ST-segment elevation acute coronary syndromes (odds ratio: 0.99; 95% confidence interval: 0.91 to 1.08; ptrend = 0.82), but increased in SIHD (odds ratio: 1.21; 95% confidence interval: 1.01 to 1.44; ptrend = 0.04) from 2003 to 2004 to 2013 to 2014. The rates of bleeding and vascular complications decreased or remained stable in all 3 subgroups, whereas risk-adjusted incidence of stroke increased in patients with STEMI or SIHD.

Conclusions

The rate of in-hospital mortality, major bleeding, vascular complications, and stroke after PCI in nonagenarians changed significantly from 2003 to 2014. This study provides a benchmark for discussion of PCI-related risks among physicians, patients, and families.





Chronological Age Is Just a Number When it Comes to Percutaneous Coronary Intervention: Why Frailty May Matter More




Nonroutine Use of Intra-Aortic Balloon Pump in Cardiogenic Shock Complicating Myocardial Infarction With Successful and Unsuccessful Primary Percutaneous Coronary Intervention
AbstractObjectives

The authors sought to compare outcomes of patients with myocardial infarction and cardiogenic shock (CS) treated with percutaneous coronary intervention (PCI) with or without intra-aortic balloon pump (IABP) support according to final epicardial flow in the infarct-related artery.

Background

A routine use of IABP is contraindicated in patients with myocardial infarction and CS. There are no data regarding the subpopulation of patients who may benefit from such support besides patients with mechanical complications of myocardial infarction.

Methods

Prospective nationwide registry data of patients with myocardial infarction and CS treated with PCI between 2003 and 2014 were analyzed. Patients were initially stratified into 2 groups according to final infarct-related artery Thrombolysis In Myocardial Infarction (TIMI) flow grade after PCI: those with successful primary PCI (TIMI flow grades 2 or 3) and those with unsuccessful primary PCI (TIMI flow grades 0 or 1). Outcomes of patients with or without IABP treatment in each group were analyzed and compared.

Results

In the unsuccessful PCI group, patients in whom IABP was applied had lower in-hospital, 30-day, and 12-month mortality. IABP support in this group of patients was an independent predictor of lower 30-day mortality (hazard ratio [HR]: 0.72; 95% confidence interval [CI]: 0.59 to 0.89; p = 0.002). Conversely, in patients with successful PCI, IABP was an independent predictor of higher 30-day mortality (HR: 1.18; 95% CI: 1.08 to 1.30; p = 0.0004).

Conclusions

IABP is associated with a lower risk of 30-day mortality in patients with myocardial infarction complicated by CS, in whom primary PCI was unsuccessful.





Intra-Aortic Balloon Pumping: In Search of the Last Remaining Indication?




Successful Percutaneous Treatment of an Acute Left Main Coronary Occlusion Due to Iatrogenic Dissection Extending Into the Ascending Aorta




Rumpel-Leede Phenomenon: Acute Dermal Capillary Rupture Complicating Radial Artery Cannulation




Instantaneous Wave-Free Ratio and Resting Pd/Pa in Tandem Lesions




Differences Between Fractional Flow Reserve and Instantaneous Wave-Free Ratio Clarified by Consideration of a Mathematical Model of Diffuse Coronary Stenosis




Clinical Sequelae of Leaflet Thrombosis Following Transcatheter Aortic Valve Replacement at Medium-Term Follow-Up




Reply: Clinical Sequelae of Leaflet Thrombosis Following Transcatheter Aortic Valve Replacement at Medium-Term Follow-Up




Coronary Artery Fenestration: A Promising Technique for Rescue Management of Spontaneous Intramural Hematoma With Luminal Compression




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