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Smartwatch Algorithm for Automated Detection of Atrial Fibrillation
AbstractBackground

The Kardia Band (KB) is a novel technology that enables patients to record a rhythm strip using an Apple Watch (Apple, Cupertino, California). The band is paired with an app providing automated detection of atrial fibrillation (AF).

Objectives

The purpose of this study was to examine whether the KB could accurately differentiate sinus rhythm (SR) from AF compared with physician-interpreted 12-lead electrocardiograms (ECGs) and KB recordings.

Methods

Consecutive patients with AF presenting for cardioversion (CV) were enrolled. Patients underwent pre-CV ECG along with a KB recording. If CV was performed, a post-CV ECG was obtained along with a KB recording. The KB interpretations were compared to physician-reviewed ECGs. The KB recordings were reviewed by blinded electrophysiologists and compared to ECG interpretations. Sensitivity, specificity, and K coefficient were measured.

Results

A total of 100 patients were enrolled (age 68 ± 11 years). Eight patients did not undergo CV as they were found to be in SR. There were 169 simultaneous ECG and KB recordings. Fifty-seven were noninterpretable by the KB. Compared with ECG, the KB interpreted AF with 93% sensitivity, 84% specificity, and a K coefficient of 0.77. Physician interpretation of KB recordings demonstrated 99% sensitivity, 83% specificity, and a K coefficient of 0.83. Of the 57 noninterpretable KB recordings, interpreting electrophysiologists diagnosed AF with 100% sensitivity, 80% specificity, and a K coefficient of 0.74. Among 113 cases where KB and physician readings of the same recording were interpretable, agreement was excellent (K coefficient = 0.88).

Conclusions

The KB algorithm for AF detection supported by physician review can accurately differentiate AF from SR. This technology can help screen patients prior to elective CV and avoid unnecessary procedures.





Smartwatches in the Fight Against Atrial Fibrillation: The Little Watch That Could




Anti-Inflammatory Therapy With Canakinumab for the Prevention and Management of Diabetes
AbstractBackground

Subclinical inflammation mediated in part by interleukin (IL)-1β participates in peripheral insulin resistance and impaired pancreatic insulin secretion.

Objectives

The authors tested the hypothesis that the IL-1β inhibitor canakinumab reduces incident diabetes.

Methods

The authors randomized 10,061 patients with prior myocardial infarction and high-sensitivity C-reactive protein (hsCRP) ≥2 mg/l to placebo or canakinumab at doses of 50 mg, 150 mg, or 300 mg subcutaneously once every 3 months. The authors tested the effects of canakinumab on major cardiovascular events in patients with and without diabetes at baseline, and evaluated as a pre-specified analysis whether canakinumab would reduce the risk of adjudicated cases of new-onset type 2 diabetes among those with protocol-defined pre-diabetes at trial entry. The authors also evaluated the effect of canakinumab on fasting plasma glucose and glycosylated hemoglobin (HbA1c) in patients with and without established diabetes.

Results

Of the participants, 4,057 (40.3%) had baseline diabetes, 4,960 (49.3%) had pre-diabetes, and 1,044 (10.4%) had normal glucose levels. Among those without diabetes, increasing tertiles of hsCRP at baseline associated with an increased risk of developing diabetes during the median follow-up period of 3.7 years (incidence rates 3.2, 4.1, and 4.4 per 100 person-years; p = 0.003). Canakinumab 150 mg as compared with placebo had similar magnitude effects on major cardiovascular event rates among those with diabetes (hazard ratio [HR]: 0.85; 95% confidence interval [CI]: 0.70 to 1.03), pre-diabetes (HR: 0.86; 95% CI: 0.70 to 1.06), and normoglycemia (HR: 0.81; 95% CI: 0.49 to 1.35). Despite large reductions in hsCRP and IL-6, canakinumab did not reduce the incidence of new-onset diabetes, with rates per 100 person-years in the placebo, 50 mg, 150 mg, and 300 mg canakinumab groups of 4.2, 4.2, 4.4, and 4.1, respectively (log-rank p = 0.84). The HR comparing all canakinumab doses to placebo was 1.02 (95% CI: 0.87 to 1.19; p = 0.82). Canakinumab reduced HbA1c during the first 6 to 9 months of treatment, but no consistent long-term benefits on HbA1c or fasting plasma glucose were observed.

Conclusions

Although IL-1β inhibition with canakinumab had similar effects on major cardiovascular events among those with and without diabetes, treatment over a median period of 3.7 years did not reduce incident diabetes. (Canakinumab Anti-inflammatory Thrombosis Outcomes Study [CANTOS]; NCT01327846)





Targeting Inflammation in the Prevention and Treatment of Type 2 Diabetes: Insights From CANTOS




Inhibition of Interleukin-1{beta} by Canakinumab and Cardiovascular Outcomes in Patients With Chronic Kidney Disease
AbstractBackground

Inflammation contributes to chronic kidney disease (CKD), in part mediated through activation of interleukin (IL)-1β by the NLRP3 inflammasome within the kidney. This process also likely contributes to the accelerated atherosclerosis associated with nephropathy.

Objectives

The authors hypothesized that canakinumab, a human monoclonal antibody targeting IL-1β, might reduce cardiovascular event rates and improve renal function among post-myocardial infarction patients with CKD.

Methods

Stable post-myocardial infarction patients with high-sensitivity C-reactive protein (hsCRP) ≥ 2mg/l were randomly allocated to placebo or to 1 of 3 doses of canakinumab (50, 150, or 300 mg) given subcutaneously once every 3 months. Participants were followed for incident myocardial infarction, stroke, hospitalization for unstable angina requiring urgent revascularization, cardiovascular death, or death from any cause over a median follow-up period of 3.7 years (maximum 5 years). All patients additionally had serial monitoring of estimated glomerular filtration rate (eGFR), creatinine, the urine albumin to creatinine ratio (uACR), and were monitored for adverse renal and urinary events.

Results

Of 10,061 participants, 1,875 (18.6%) had baseline eGFR <60 ml/min/1.73 m2. These moderate CKD patients had higher incidence rates for major adverse vascular events compared with those with eGFR ≥60 ml/min/1.73 m2 (6.92 vs. 4.13 per 100 person-years; p < 0.0001). Random allocation to canakinumab reduced the risk of major adverse cardiovascular events among those with CKD (hazard ratio: 0.82; 95% confidence interval: 0.68 to 1.00; p = 0.05) with the largest cardiovascular benefits accruing among those who achieved on-treatment hsCRP levels below 2 mg/l measured after taking the first dose (hazard ratio: 0.68; 95% confidence interval: 0.53 to 0.86; p = 0.0015). Comparable effects were observed among those with baseline albuminuria or diabetes. Canakinumab had neither clinically meaningful benefits nor substantive harms with respect to serial measures of eGFR, creatinine, the uACR, or reported adverse renal events during trial follow-up.

Conclusions

IL-1β inhibition with canakinumab reduces major adverse cardiovascular event rates among high-risk atherosclerosis patients with CKD, particularly among those with a robust anti-inflammatory response to initial treatment. These cardiovascular benefits accrued with no adverse clinical renal events. (Canakinumab Anti-inflammatory Thrombosis Outcomes Study [CANTOS]; NCT01327846)





Cardiovascular Risk Reduction in Patients With Chronic Kidney Disease: Potential for Targeting Inflammation With Canakinumab




Pregnancy Outcomes in Women With Heart Disease: The CARPREG II Study
AbstractBackground

Identifying women at high risk is an important aspect of care for women with heart disease.

Objectives

This study sought to: 1) examine cardiac complications during pregnancy and their temporal trends; and 2) derive a risk stratification index.

Methods

We prospectively enrolled consecutive pregnant women with heart disease and determined their cardiac outcomes during pregnancy. Temporal trends in complications were examined. A multivariate analysis was performed to identify predictors of cardiac complications and these were incorporated into a new risk index.

Results

In total, 1,938 pregnancies were included. Cardiac complications occurred in 16% of pregnancies and were primarily related to arrhythmias and heart failure. Although the overall rates of cardiac complications during pregnancy did not change over the years, the frequency of pulmonary edema decreased (8% from 1994 to 2001 vs. 4% from 2001 to 2014; p value = 0.012). Ten predictors of maternal cardiac complications were identified: 5 general predictors (prior cardiac events or arrhythmias, poor functional class or cyanosis, high-risk valve disease/left ventricular outflow tract obstruction, systemic ventricular dysfunction, no prior cardiac interventions); 4 lesion-specific predictors (mechanical valves, high-risk aortopathies, pulmonary hypertension, coronary artery disease); and 1 delivery of care predictor (late pregnancy assessment). These 10 predictors were incorporated into a new risk index (CARPREG II [Cardiac Disease in Pregnancy Study]).

Conclusions

Pregnancy in women with heart disease continues to be associated with significant morbidity, although mortality is rare. Prediction of maternal cardiac complications in women with heart disease is enhanced by integration of general, lesion-specific, and delivery of care variables.





How to Predict Pregnancy Risk in an Individual Woman With Heart Disease




Trends in Long-Term Mortality After Congenital Heart Surgery
AbstractBackground

Congenital heart surgery has improved the survival of patients with even the most complex defects, but the long-term survival after these procedures has not been fully described.

Objectives

The purpose of this study was to evaluate the long-term survival of patients (age <21 years) who were operated on for congenital heart defects (CHDs).

Methods

This study used the Pediatric Cardiac Care Consortium data, a U.S.-based, multicenter registry of pediatric cardiac surgery. Survival analysis included 35,998 patients who survived their first congenital heart surgery at <21 years of age and had adequate identifiers for linkage with the National Death Index through 2014. Survival was compared to that in the general population using standardized mortality ratios (SMRs).

Results

After a median follow-up of 18 years (645,806 person-years), 3,191 deaths occurred with an overall SMR of 8.3 (95% confidence interval [CI]: 8.0 to 8.7). The 15-year SMR decreased from 12.7 (95% CI: 11.9 to 13.6) in the early era (1982 to 1992) to 10.0 (95% CI: 9.3 to 10.8) in the late era (1998 to 2003). The SMR remained elevated even for mild forms of CHD such as patent ductus arteriosus (SMR 4.5) and atrial septal defects (SMR 4.9). The largest decreases in SMR occurred for patients with transposition of great arteries (early: 11.0 vs. late: 3.8; p < 0.05), complete atrioventricular canal (31.3 vs. 15.3; p < 0.05), and single ventricle (53.7 vs. 31.3; p < 0.05).

Conclusions

In this large U.S. cohort, long-term mortality after congenital heart surgery was elevated across all forms of CHD. Survival has improved over time, particularly for severe defects with significant changes in their management strategy, but still lags behind the general population.





Public Health Approach to Decrease Mortality for Congenital Heart Defects: Dying Too Soon




Antithrombotic Therapy for Peripheral Artery Disease: Recent Advances
Abstract

Peripheral artery disease (PAD) affects over 200 million people globally and is a cause of significant morbidity, mortality, and disability due to limb loss. Although secondary prevention with antithrombotic therapy is a mainstay of treatment to prevent adverse cardiovascular events, PAD patients are often undertreated with antithrombotic agents. Furthermore, there is a paucity of high-quality data from randomized controlled trials of PAD patients, leading to wide variations in clinical practice and guideline recommendations. Recently, there have been important advances that have further increased the number of antiplatelet and anticoagulant choices potentially available for patients with PAD. In this context, this paper aims to summarize the current available evidence for the safety and efficacy of various antithrombotic agents in PAD, and discuss how to integrate this emerging evidence into actual clinical practice. An evidenced-based approach to PAD patients is essential to achieve optimal outcomes, weighing cardiovascular and limb benefits against bleeding risks.





Chronic Thromboembolic Pulmonary Hypertension: Evolving Therapeutic Approaches for Operable and Inoperable Disease
Abstract

Chronic thromboembolic pulmonary hypertension (CTEPH), a rare consequence of an acute pulmonary embolism, is a disease that is underdiagnosed, and surgical pulmonary thromboendarterectomy (PTE) remains the preferred therapy. However, determination of operability is multifactorial and can be challenging. There is growing excitement for the percutaneous treatment of inoperable CTEPH with data from multiple centers around the world showing the clinical feasibility of balloon pulmonary angioplasty. Riociguat remains the only approved medical therapy for CTEPH patients deemed inoperable or with persistent pulmonary hypertension after PTE. We recommend that expert multidisciplinary CTEPH teams be developed at individual institutions. Additionally, optimal and standardized techniques for balloon pulmonary angioplasty need to be developed along with dedicated interventional equipment and appropriate training standards. In the meantime, the percutaneous revascularization option is appropriate for patients deemed inoperable in combination with targeted medical therapy, or those who have failed to benefit from surgery.





Impact of C-Reactive Protein and Coronary Artery Calcium on Benefit Observed With Atorvastatin




SAVR Versus TAVR Outcomes in Patients With Prior History of Stroke




Cardiovascular Risk Models and Statin Therapy




Reply: Cardiovascular Risk Models and Statin Therapy




Missed Opportunities in Cardiac Arrest: The Promise of 24/7 Ongoing On-Site Interventional Cardiologist Availability




Off-Hours and In-Hospital Mortality: Lower Resources or Higher Severity?




Reply: Lower Survival for In-Hospital Cardiac Arrests During Nights and Weekends




Correction




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JACC: Cardiovascular Interventions recent issues

JACC: Cardiovascular Interventions RSS feed -- recent issues

Restenosis in Magmaris Stents Due to Significant Collapse




Marking Technique for Identification of Optimal Stent Landing Site With Optical Coherence Tomographic Imaging




Acute Iliac Vein Thrombosis Secondary to Exacerbation of May-Thurner Syndrome by Overriding Arterial Crossover Sheath




Adventitial Drug Delivery of Dexamethasone to Improve Primary Patency in the Treatment of Superficial Femoral and Popliteal Artery Disease: 12-Month Results From the DANCE Clinical Trial
AbstractObjectives

This study was designed to evaluate outcomes of adventitial dexamethasone delivery adjunctive to standard endovascular revascularization in femoropopliteal peripheral artery disease.

Background

Drug-coated balloons and drug-eluting stents improve patency of endovascular interventions with passive diffusion of antiproliferative drugs. Adventitial dexamethasone delivery targets the initial triggers of the inflammatory reaction to injury, thus potentially providing a potent antirestenotic strategy.

Methods

The single-arm DANCE (Dexamethasone to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization) trial enrolled 262 subjects (283 limbs) with symptomatic peripheral artery disease (Rutherford category 2 to 4) receiving percutaneous transluminal angioplasty (PTA) (n = 124) or atherectomy (ATX) (n = 159) in femoropopliteal lesions ≤15 cm in length. A mixture of dexamethasone/contrast medium (80%/20%) was delivered to the adventitia and perivascular tissues surrounding target lesions in all subjects. Thirty-day assessments included major adverse limb events (MALE) and post-operative death. Twelve-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), Rutherford scoring, and walking impairment questionnaire.

Results

At 12 months, primary patency rates in DANCE-ATX and -PTA per-protocol populations were 78.4% (74.8% intent-to-treat [ITT]) and 75.5% (74.3% ITT), respectively. Rates of CD-TLR in DANCE-ATX and -PTA subjects were 10.0% (13.1% ITT) and 11.0% (13.7% ITT), respectively. There were no 30-day MALE + post-operative death events nor 12-month device- or drug-related deaths or MALE.

Conclusions

Direct adventitial delivery of dexamethasone appears to be an effective and safe therapy to prevent restenosis. Randomized studies are needed to further test this possibility. (Dexamethasone to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization [DANCE]; NCT01983449)





Needle-Delivered Drug Elution in Femoral Artery Disease




12-Month Results From the First-in-Human Randomized Study of the Ranger Paclitaxel-Coated Balloon for Femoropopliteal Treatment
AbstractObjectives

The authors sought to evaluate the performance of the Ranger paclitaxel-coated balloon versus uncoated balloon angioplasty for femoropopliteal lesions at 12 months.

Background

Drug-coated balloons (DCBs) are a promising endovascular treatment option for peripheral artery disease of the femoropopliteal segment, and each unique device requires dedicated clinical study.

Methods

The prospective, randomized RANGER SFA (Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries) study (NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2 to 4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68 ± 8 years, n = 53 men) were enrolled in the Ranger DCB arm, and 34 patients (mean age 67 ± 9 years, n = 23 men) were assigned to the control group. Twelve-month analysis included patency, safety, and clinical outcomes and quality-of-life assessments.

Results

The DCB group had a greater primary patency rate at 12 months (Kaplan-Meier estimate 86.4% vs. 56.5%), with a significantly longer time to patency failure (log-rank p < 0.001). The estimated freedom from target lesion revascularization rate was 91.2% in the DCB group and 69.9% in the control group at 12 months, with a significantly longer time to reintervention (p = 0.010). No target limb amputations or device-related deaths occurred in either group.

Conclusions

Twelve-month results show that patency was maintained longer after Ranger DCB treatment than after conventional balloon angioplasty, and this result was associated with a low revascularization rate and good clinical outcomes.





More Evidence and More Questions About Paclitaxel-Coated Balloons in the Femoropopliteal Segment




Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study
AbstractObjectives

The IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials.

Background

Randomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions.

Methods

The IN.PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization was evaluated at 24 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months.

Results

Mean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease were associated with increased risk for clinically driven target lesion revascularization by 24 months.

Conclusions

This real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (IN.PACT Global Clinical Study; NCT01609296)





2-Year Outcomes From the Largest Real-Life Global Registry Investigating Drug-Coated Balloon Angioplasty for Femoropopliteal Artery Disease: Time for a Treatment Shift Toward Drug Elution and Minimal Stenting?




1-Year All-Comers Analysis of the Eluvia Drug-Eluting Stent for Long Femoropopliteal Lesions After Suboptimal Angioplasty
AbstractObjectives

The aim of this study was to assess the performance of the fluoropolymer-based paclitaxel-eluting stent (PES) in long femoropopliteal lesions.

Background

The new-generation fluoropolymer-based PES showed promising outcomes in short femoropopliteal lesions. The main feature of the stent is its controlled and sustained paclitaxel release over 12 months. However, the safety and efficacy of this technology in longer femoropopliteal lesions remain unclear.

Methods

Between March 2016 and March 2017, 62 patients were included in this analysis. Indications for fluoropolymer-based PES deployment were insufficient luminal gain or flow-limiting dissection after plain old balloon angioplasty in a femoropopliteal lesion. Primary patency, freedom from target lesion revascularization, amputation-free survival, and paclitaxel-related adverse events were retrospectively analyzed for up to 1 year of follow-up.

Results

Lesions were de novo in 84% of patients. Mean lesion length was 20 ± 12 cm, and 79% of the lesions (n = 49) were chronic total occlusions. Moderate or severe calcification was present in 42% of the lesions (n = 26). Stent implantation involved the distal superficial femoral artery and the proximal popliteal artery in 76% (n = 47) and 44% (n = 27) of patients, respectively. The Kaplan-Meier estimate of primary patency and freedom from target lesion revascularization was 87%. Amputation-free survival was 100% for patients with claudication (n = 32 [52%]) and 87% in patients with critical limb ischemia (n = 30 [48%]) (hazard ratio: 6.3; 95% confidence interval: 1.25 to 31.54; p = 0.052). Five aneurysm formations of the treated segments (8%) were thought to be attributable to paclitaxel.

Conclusions

The fluoropolymer-based PES showed promising 1-year clinical and angiographic outcomes in real-world long femoropopliteal lesions. The long-term impact of aneurysm formation remains to be further investigated.





Paclitaxel-Eluting Stents and Aneurysm Formation, A Worrisome Association




Impact of Optimized Procedure-Related Factors in Drug-Eluting Balloon Angioplasty for Treatment of In-Stent Restenosis
AbstractObjectives

The aim of this study was to investigate the impact of optimizing procedure-related factors during drug-eluting balloon (DEB) angioplasty on clinical outcomes of drug-eluting stent in-stent restenosis (ISR).

Background

Although DEB angioplasty is recommended as a reasonable option for ISR, recurrent target lesion failure (TLF) still occurs in many patients after DEB angioplasty.

Methods

Consecutive patients with drug-eluting stent ISR treated with DEB (SeQuent Please) were collected from 4 centers in Korea. The primary outcome was 2-year TLF. Procedure-related modifiable independent predictors for TLF and their best cutoff values were determined.

Results

In a total of 256 patients (309 lesions), TLF occurred in 52 patients (20.3%). Modifiable independent predictors of TLF among procedure-related factors were residual diameter stenosis after lesion preparation (residual percentage diameter stenosis [%DS]), DEB-to-stent ratio (BSR), and DEB inflation time (Tinflation), whose best cutoff values were 20%, 0.91, and 60 s, respectively. TLF rates were significantly higher in groups with residual %DS ≥20% (34.7% vs. 12.5%; adjusted hazard ratio: 2.15; 95% confidence interval: 1.86 to 2.48; p < 0.001), BSR ≤0.91 (46.4% vs. 21.9%; adjusted hazard ratio: 2.02; 95% confidence interval: 1.75 to 2.34; p < 0.001), and Tinflation ≤60 s (26.2% vs. 14.0%; adjusted hazard ratio: 1.82; 95% confidence interval: 1.36 to 2.45; p < 0.001). When classifying ISR lesions by combination of procedure-related factors, TLF occurred in 8.3% in the fully optimized procedure group (residual %DS <20%, BSR >0.91, and Tinflation >60 s) and 66.7% in the nonoptimized group (residual %DS ≥20%, BSR ≤0.91, and Tinflation ≤60 s) (p < 0.001).

Conclusions

Residual %DS after lesion preparation, BSR, and Tinflation were the only modifiable procedure-related factors in DEB angioplasty. Fully optimized DEB angioplasty with optimal lesion preparation, prolonged inflation, and sufficient dilation may play an important role in reducing TLF after DEB angioplasty.





Drug-Eluting Balloon Therapy for In-Stent Restenosis of Drug-Eluting Stents: Choose and Prepare the Appropriate Lesion




3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents
AbstractObjectives

This study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES).

Background

Treatment of patients with DES-ISR remains a challenge.

Methods

The RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study.

Results

A total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01). Three-year clinical follow-up was obtained in all enrolled patients (100%). The combined clinical outcome measure of cardiac death, myocardial infarction and target lesion revascularization was significantly reduced in the EES arm (19 [12.3%] vs. 31 [20.1%]; p = 0.04; hazard ratio: 0.57 [95% confidence interval: 0.34 to 0.96]), driven by a lower need for target lesion revascularization (11 [7.1%] vs. 24 [15.6%]; p = 0.015; hazard ratio: 0.43 [95% confidence interval: 0.21 to 0.87]). The need for "late" (>1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms.

Conclusions

The 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940)





Farewell to Drug-Eluting Balloons for In-Stent Restonsis?: Appropriate Technique of Drug-Eluting Balloons Implantation Matters




Comparison of a Novel Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent: 5-Year Outcomes of the Randomized BIOFLOW-II Trial
AbstractObjectives

The authors aimed to compare long-term data of an ultrathin cobalt-chromium stent with passive silicon carbide coating and an active biodegradable polymer that releases sirolimus (O-SES) (Orsiro, BIOTRONIK, Bülach, Switzerland) with the durable polymer-based Xience Prime everolimus-eluting stent (X-EES) (Abbott Vascular, Santa Clara, California).

Background

Biodegradable polymer stents have been developed aiming to overcome long-term detrimental effects of durable polymer stents, ultimately leaving a bare-metal stent in the vessel.

Methods

This multicenter, assessor-blinded trial randomized 452 patients with 505 lesions to either O-SES or X-EES in a 2:1 fashion. Endpoints at 5 years were target lesion failure (TLF), its components, and stent thrombosis.

Results

TLF occurred in 10.4% (n = 30) of O-SES patients versus 12.7% (n = 19) of X-EES patients (p = 0.473), overall stent thrombosis occurred in 0.7% (n = 2) versus 2.8% (n = 4) (p = 0.088), and definite stent thrombosis in 0% versus 0.7% (n = 1) (p = 0.341). Post hoc analysis was performed in diabetic patients (n = 128) and vessels ≤2.75 mm (n = 259). In diabetic patients, the O-SES group had numerically more target lesion revascularizations (13.5% vs. 4.5%; p = 0.138), but fewer cardiac deaths (1.3% vs. 6.9%; p = 0.089) and stent thrombosis (0% vs. 6.9%; p = 0.039). In small vessels, the O-SES group had a significantly lower 5-year mortality (3.7% vs. 11.3%; p = 0.022).

Conclusions

At 5 years, the biodegradable polymer O-SES demonstrated low TLF rates comparable to the durable polymer X-EES, confirming its long-term safety and performance. Particularly encouraging is the absence of definite stent thrombosis.





Biodegradable-Polymer Drug-Eluting Stent Platforms: The Importance of Long-Term Outcomes




Extensive Iliofemoral Occlusion After Aortobifemoral Bypass Occlusion: The Potential of Native Artery Recanalization




Left Ventricular Assist Device Outflow Conduit Fissuration: Endovascular Salvage




Disease Burden and Clinical Outcomes Following Initial Diagnosis of Critical Limb Ischemia in the Medicare Population




The Long-Term Impact of Post-Procedural Asymmetry and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial




Predictors of Calcium Fracture Derived From Balloon Angioplasty and its Effect on Stent Expansion Assessed by Optical Coherence Tomography




Images in Intervention: Icons




Spontaneous Retrograde Embolization From an Infarct-Related Artery to a Bystander Nonculprit Artery: An Unclear Pathophysiological Mechanism?




Delayed Left Main Narrowing From the Native Left Aortic Valve Leaflet After Transcatheter Aortic Valve Replacement With the Lotus Valve: A Successful Intervention for a Novel Complication




The 0.035-Inch Wire Externalization Technique for Overcoming a Severely Angled and Calcified Aortic Bifurcation




Defining Staged Procedures for Percutaneous Coronary Intervention Trials: A Guidance Document
Abstract

Patients in coronary intervention trials may require more than 1 procedure to complete the intended revascularization strategy. However, these staged interventions are not consistently defined. Standardized definitions are needed to allow meaningful comparisons of this outcome among trials. This document provides guidance on relevant parameters involving staged procedures, including minimum data collection and consistent classification of coronary procedures initially identified as staged; the aim is to achieve consistency among clinical trialists, sponsors, health authorities, and regulators. Definitions were developed jointly among representatives of academic institutions and clinical research organizations based on clinical trial experience and published literature. Reasons for staged procedures were identified and include baseline kidney function, contrast load and radiation exposure, lesion complexity, and patient or operator fatigue. Moreover, nonclinical reasons include procedure scheduling and reimbursement. Management of staged procedures should be a standalone section in clinical trial protocols and clinical events committee charters. These documents should clearly define a time window for staged procedures that allows latitude for local policies, while respecting accepted clinical guidelines, and consistency with study objectives. Investigators should document in the case report form the intent to stage a procedure, the lesions to be treated, and the reasons for staging, preferably before randomization. Ideally, all reinterventions, or at least all procedures performed after the recommended time window, those in which data suggest an anticipated procedure due to a worsening condition and those where a revascularization is attempted in the target vessel, should be reviewed by an independent clinical events committee.





Complete Revascularization During Primary Percutaneous Coronary Intervention Reduces Death and Myocardial Infarction in Patients With Multivessel Disease: Meta-Analysis and Meta-Regression of Randomized Trials
AbstractObjectives

The aim of this study was to compare complete revascularization with a culprit-only strategy in patients presenting with ST-segment elevation myocardial infarction (MI) and multivessel disease by a meta-analysis of randomized trials.

Background

Although several trials have compared complete with culprit-only revascularization in ST-segment elevation MI, it remains unclear whether complete revascularization may lead to improvement in hard endpoints (death and MI).

Methods

Randomized trials comparing complete revascularization with culprit-only revascularization in patients with ST-segment elevation MI without cardiogenic shock were identified by a systematic search of published research. Random-effects meta-analysis was performed, comparing clinical outcomes in the 2 groups.

Results

Eleven trials were identified, including a total of 3,561 patients. Compared with a culprit-only strategy, complete revascularization significantly reduced risk for death or MI (relative risk [RR]: 0.76; 95% confidence interval [CI]: 0.58 to 0.99; p = 0.04). Meta-regression showed that performing complete revascularization at the time of primary percutaneous coronary intervention (PCI) was associated with better outcomes (p = 0.016). The 6 trials performing complete revascularization during primary PCI (immediate revascularization) were associated with a significant reduction in risk for both total mortality (RR: 0.62; 95% CI: 0.39 to 0.97; p = 0.03) and MI (RR: 0.40; 95% CI: 0.25 to 0.66; p < 0.001), whereas the 5 trials performing only staged revascularization did not show any significant benefit in either total mortality (RR: 1.02; 95% CI: 0.65 to 1.62; p = 0.87) or MI (RR: 1.04; 95% CI: 0.48 to 1.68; p = 0.86).

Conclusions

When feasible, complete revascularization with PCI can significantly reduce the combined endpoint of death and MI. Complete revascularization performed during primary PCI was also associated with significant reductions in both total mortality and MI, whereas staged revascularization did not improve these outcomes.





Should a Meta-Analysis Guide Our Practice?




Hybrid Coronary Revascularization in Selected Patients With Multivessel Disease: 5-Year Clinical Outcomes of the Prospective Randomized Pilot Study
AbstractObjectives

This study aimed to investigate the 5-year clinical follow-up of the HYBRID (Hybrid Revascularization for Multivessel Coronary Artery Disease) trial.

Background

The HYBRID trial, the only randomized study involving thorough analysis of outcome after the 2 procedures, suggested that hybrid coronary revascularization (HCR) is feasible in selected patients with multivessel coronary disease referred for conventional coronary artery bypass grafting (CABG). There are currently no long-term outcome data from randomized trials in this setting.

Methods

A total of 200 patients with multivessel coronary disease referred for conventional surgical revascularization were randomly assigned to undergo HCR or CABG. The primary endpoint was the occurrence of all-cause mortality at 5 years.

Results

Nine patients (4 in HCR and 5 in CABG group) were lost to the 5-year follow-up. Finally, 191 patients (94 in HCR and 97 in CABG group) formed the basis of this study. The groups were well balanced in terms of pre-procedural characteristics. All-cause mortality at 5-year follow-up was similar in the 2 groups (6.4% for HCR vs. 9.2% for CABG; p = 0.69). The rates of myocardial infarction (4.3% vs. 7.2%; p = 0.30), repeat revascularization (37.2% vs. 45.4%; p = 0.38), stroke (2.1% vs. 4.1%; p = 0.35), and major adverse cardiac and cerebrovascular events (45.2% vs. 53.4%; p = 0.39) were also similar in the 2 groups.

Conclusions

HCR has similar 5-year all-cause mortality when compared with conventional coronary bypass grafting (Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease; NCT01035567)





Hybrid Coronary Revascularization 5 Years On: Is Clinical Equipoise Good Enough?




Prognostic and Practical Validation of Current Definitions of Myocardial Infarction Associated With Percutaneous Coronary Intervention
AbstractObjectives

In 13,038 patients with non–ST-segment elevation acute coronary syndrome undergoing index percutaneous coronary intervention (PCI) in the EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non–ST-Segment Elevation Acute Coronary Syndrome) and TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) trials, the relationship between PCI-related myocardial infarction (MI) and 1-year mortality was assessed.

Background

The definition of PCI-related MI is controversial. The third universal definition of PCI-related MI requires cardiac troponin >5 times the 99th percentile of the normal reference limit from a stable or falling baseline and PCI-related clinical or angiographic complications. The definition from the Society for Cardiovascular Angiography and Interventions (SCAI) requires creatine kinase–MB elevation >10 times the upper limit of normal (or 5 times if new electrocardiographic Q waves are present). Implications of these definitions on prognosis, prevalence, and implementation are not established.

Methods

In our cohort of patients undergoing PCI, PCI-related MIs were classified using the third universal type 4a MI definition and SCAI criteria. In the subgroup of patients included in the angiographic core laboratory (ACL) substudy of EARLY ACS (n = 1,401) local investigator– versus ACL-reported angiographic complications were compared.

Results

Altogether, 2.0% of patients met third universal definition of PCI-related MI criteria, and 1.2% met SCAI criteria. One-year mortality was 3.3% with the third universal definition (hazard ratio: 1.96; 95% confidence interval: 1.24 to 3.10) and 5.3% with SCAI criteria (hazard ratio: 2.79; 95% confidence interval: 1.69 to 4.58; p < 0.001). Agreement between ACL and local investigators in detecting angiographic complications during PCI was overall moderate ( = 0.53).

Conclusions

The third universal definition of MI and the SCAI definition were both associated with significant risk for mortality at 1 year. Suboptimal concordance was observed between ACL and local investigators in identifying patients with PCI complications detected on angiography. (Trial to Assess the Effects of Vorapaxar [SCH 530348; MK-5348] in Preventing Heart Attack and Stroke in Participants With Acute Coronary Syndrome [TRA·CER] [Study P04736]; NCT00527943; EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non–ST-Segment Elevation Acute Coronary Syndrome [Study P03684AM2]; NCT00089895)





Current Definitions of Non-ST-Segment Elevation Myocardial Infarction: Challenges for Further Improvement




Elective Coronary Revascularization Procedures in Patients With Stable Coronary Artery Disease: Incidence, Determinants, and Outcome (From the CORONOR Study)
AbstractObjectives

The authors sought to describe the incidence, determinants, and outcome of elective coronary revascularization (ECR) in patients with stable coronary artery disease (CAD).

Background

Observational data are lacking regarding the practice of ECR in patients with stable CAD receiving modern secondary prevention.

Methods

The authors analyzed coronary revascularization procedures performed during a 5-year follow-up in 4,094 stable CAD outpatients included in the prospective multicenter CORONOR (Suivi d'une cohorte de patients COROnariens stables en région NORd-Pas-de-Calais) registry.

Results

Secondary prevention medications were widely prescribed at inclusion (antiplatelet agents 96.4%, statins 92.2%, renin-angiotensin system antagonists 81.8%). A total of 481 patients underwent ≥1 coronary revascularization procedure (5-year cumulative incidences of 3.6% [0.7% per year] for acute revascularizations and 8.9% [1.8% per year] for ECR); there were 677 deaths during the same period. Seven baseline variables were independently associated with ECR: prior coronary stent implantation (p < 0.0001), absence of prior myocardial infarction (p < 0.0001), higher low-density lipoprotein cholesterol (p < 0.0001), lower age (p < 0.0001), multivessel CAD (p = 0.003), diabetes mellitus (p = 0.005), and absence of treatment with renin-angiotensin system antagonists (p = 0.020). Main indications for ECR were angina associated with a positive stress test (31%), silent ischemia (31%), and angina alone (25%). The use of ECR had no impact on the subsequent risk of death, myocardial infarction, or ischemic stroke (hazard ratio: 1.04; 95% confidence interval: 0.76 to 1.41).

Conclusions

These real-life data show that ECR is performed at a rate of 1.8% per year in stable CAD patients widely treated by secondary medical prevention. ECR procedures performed in patients without noninvasive stress tests are not rare. Having an ECR was not associated with the risk of ischemic adverse events.





Revascularization for Stable Ischemic Heart Disease: The Courage to Use What We Have Learned




Temporal Trends in Coronary Angiography and Percutaneous Coronary Intervention: Insights From the VA Clinical Assessment, Reporting, and Tracking Program
AbstractObjectives

The aim of this study was to evaluate temporal trends in characteristics and outcomes among patients referred for invasive coronary procedures within a national health care system for veterans.

Background

Coronary angiography and percutaneous coronary intervention remain instrumental diagnostic and therapeutic interventions for coronary artery disease.

Methods

All coronary angiographic studies and interventions performed in U.S. Department of Veterans Affairs cardiac catheterization laboratories for fiscal years 2009 through 2015 were identified. The demographic characteristics and management of these patients were stratified by time. Clinical outcomes including readmission (30-day) and mortality were assessed across years.

Results

From 2009 to 2015, 194,476 coronary angiographic examinations and 85,024 interventions were performed at Veterans Affairs facilities. The median numbers of angiographic studies (p = 0.81) and interventions (p = 0.22) remained constant over time. Patients undergoing these procedures were progressively older, with more comorbidities, as the proportion classified as having high Framingham risk significantly increased among those undergoing angiography (from 20% to 25%; p < 0.001) and intervention (from 24% to 32%; p < 0.001). Similarly, the median National Cardiovascular Data Registry CathPCI risk score increased for diagnostic (from 14 to 15; p = 0.005) and interventional (from 14 to 18; p = 0.002) procedures. Post-procedural medical management was unchanged over time, although there was increasing adoption of transradial access for diagnostic (from 6% to 36%; p < 0.001) and interventional (from 5% to 32%; p < 0.001) procedures. Complications and clinical outcomes also remained constant, with a trend toward a reduction in the adjusted hazard ratio for percutaneous coronary intervention mortality (hazard ratio: 0.983; 95% confidence interval: 0.967 to 1.000).

Conclusions

Veterans undergoing invasive coronary procedures have had increasing medical complexity over time, without attendant increases in mortality among those receiving interventions. As the Department of Veterans Affairs moves toward a mix of integrated and community-based care, it will be important to account for these demographic shifts so that quality can be maintained.





Mature Technology for Mature Patients: The Increasing Complexities of Patients Treated With Coronary Angiography and Interventions




Mortality Following Nonemergent, Uncomplicated Target Lesion Revascularization After Percutaneous Coronary Intervention: An Individual Patient Data Pooled Analysis of 21 Randomized Trials and 32,524 Patients
AbstractObjectives

This study sought to investigate the impact of nonemergent, uncomplicated target lesion revascularization (TLR) on the risk of long-term mortality after percutaneous coronary intervention (PCI).

Background

Restenosis requiring TLR after PCI is generally considered a benign event.

Methods

The study pooled patient-level data from 21 randomized trials. Subjects dying the same day as or the day after the TLR procedure as well as those with myocardial infarction (MI) the day before, the same day as or the day after TLR were excluded. The primary endpoint of the study was all-cause mortality.

Results

The dataset included 32,524 patients who were stratified according to whether repeat TLR was performed during follow-up. During a median follow-up of 37 months, 2,330 (7.2%) patients underwent a nonemergent, uncomplicated TLR procedure. After adjusting for potential confounders, TLR was an independent predictor of mortality (hazard ratio: 1.23, 95% confidence interval: 1.04 to 1.45; p = 0.02). Patients undergoing nonemergent, uncomplicated TLR had significantly higher rates of non–procedure-related MI compared with those without TVR. Among patients undergoing elective TLR, MI occurring after TLR was an independent predictor of mortality (hazard ratio: 3.82; 95% confidence interval: 2.44 to 5.99; p < 0.0001).

Conclusions

Nonemergent, uncomplicated TLR after PCI is an independent predictor of long-term mortality, an association in part explained by higher rates of MI occurring after TLR. Efforts aimed at reducing TLR risk may translate into prognostic benefits including reduced rates of MI and survival.





A Not Entirely Benign Procedure




Simultaneous Thrombosis and Hemorrhage: Endovascular Approach to Both Conditions




Histopathology of Coronary Fibromuscular Dysplasia Causing Spontaneous Coronary Artery Dissection




A Man With a 40-Year Event-Free Follow-Up After Percutaneous Coronary Intervention




State Variation in the Use of Non-Acute Coronary Angiograms and Coronary Revascularization Procedures




Temporal Trends in Inpatient Use of Intravascular Imaging Among Patients Undergoing Percutaneous Coronary Intervention in the United States




Impact of Off-Hours Versus On-Hours Primary Percutaneous Coronary Intervention on Myocardial Damage and Clinical Outcomes in ST-Segment Elevation Myocardial Infarction




Correction




Correction




Correction




Hybrid Closure of Apical Post-Infarct Septal Defect: Externalizing an Occluder and Excluding the Right Ventricle




Successful Catheter Treatment Using Pre-Operative 3D Organ Model Simulation for Atrial Septal Defect With Dextrocardia and Interrupted Inferior Vena Cava to the Superior Vena Cava




Successful Percutaneous Retrieval of a 33-mm Watchman Left Atrial Appendage Occlusion Device From the Left Atrium




Influence of Local Myocardial Damage on Index of Microcirculatory Resistance and Fractional Flow Reserve in Target and Nontarget Vascular Territories in a Porcine Microvascular Injury Model
AbstractObjectives

The aim of this study was to investigate the influence of microvascular damage in one vessel territory on invasively measured physiological parameters in the other vessel, using a porcine microvascular damage model.

Background

Although fractional flow reserve (FFR)-guided decision-making for the nonculprit stenosis in patients with acute myocardial infarction has been reported to be better than angiography-guided revascularization, there have been debates regarding the influence of microvascular dysfunction on measured FFR in nonculprit vessels.

Methods

In Yorkshire swine, microvascular damage was induced with selective intracoronary injection of microspheres (100 μm x 105 each) into the left anterior descending artery (LAD). Coronary stenosis was created in both the LAD and the left circumflex artery (LCx) using balloon catheters. Coronary physiological changes were assessed with index of microcirculatory resistance (IMR) and FFR at baseline and at each subsequent injection of microsphere up to a fifth dose in both the LAD and LCx. Measurements were repeated 5 times at each stage, and a total of 424 measurements were made in 12 Yorkshire swine models.

Results

The median area stenosis in LAD and LCx was 48.1% (interquartile range: 40.8% to 50.4%) and 47.9% (interquartile range: 31.1% to 62.9%), respectively. At baseline, FFR in the LAD was lower than that in the LCx (0.89 ± 0.01 and 0.94 ± 0.01; p < 0.001). There was no difference in the IMR (18.4 ± 5.8 U and 17.9 ± 1.2 U; p = 0.847). With repeated injections of microspheres, IMR in LAD was significantly increased, up to 77.7 ± 15.7 U (p < 0.001). Given the same stenosis, FFR in the LAD was also significantly increased, up to 0.98 ± 0.01 along with IMR increase (p < 0.001). Conversely, IMR and FFR were not changed in the LCx throughout repeated injury to the LAD territory (p = 0.105 and p = 0.286 for IMR and FFR, respectively). The increase in LAD IMR was mainly driven by the increase in hyperemic mean transit time (p < 0.001).

Conclusions

In Yorkshire swine models, local microvascular damage increased both FFR and IMR in a vessel supplying target myocardial territory. However, IMR and FFR were maintained in the other vessel. These physiological results in swine support the concept that FFR measurement might provide useful information for evaluating nonculprit lesions in clinical settings involving significant acute myocardial injury.





Fractional Flow Reserve in Nonculprit Vessel During ST-Segment Elevation Myocardial Infarction: Reliable or Prone to Error?




Diagnostic and Prognostic Efficacy of Coronary Flow Capacity Obtained Using Pressure-Temperature Sensor-Tipped Wire-Derived Physiological Indices
AbstractObjectives

This study aimed to evaluate the feasibility and efficacy of pressure-temperature sensor–tipped wire–derived coronary flow capacity (PTW-CFC) for assessing flow impairment and prognosis.

Background

CFC provides an integrated coronary physiological assessment in which coronary flow reserve and coronary flow during hyperemia are organized.

Methods

A total of 643 native de novo lesions for which physiological assessments were performed using a PressureWire (St. Jude Medical, St. Paul, Minnesota) in patients with stable coronary artery disease were identified. The entire cohort was stratified by PTW-CFC according to the well-validated thresholds of coronary flow reserve and the corresponding inverse of thermodilution-derived mean transit time under hyperemia. Coronary physiological indices and the prevalence of major adverse cardiac events (MACE) were assessed according to PTW-CFC categories. Furthermore, in patients who underwent percutaneous coronary intervention (PCI), post-PCI PTW-CFC categorization was performed and clinical outcomes were evaluated.

Results

PTW-CFC categorization efficiently discriminated previously validated coronary physiological parameters for functional stenosis severity and microvascular dysfunction. MACE rates during follow-up (2.4 years) were significantly associated with advanced impairment of PTW-CFC except for severely reduced PTW-CFC. In the subgroup analysis of patients with severely reduced pre-PCI PTW-CFC who underwent successful PCI, MACE incidence was significantly frequent in patients with post-PCI non-normal PTW-CFC compared with those with post-PCI normal PTW-CFC.

Conclusions

PTW-CFC mapping was feasible, provided accurate stratifications of coronary flow impairment, and may predict MACE. Combined analysis involving PTW-CFC and fractional flow reserve may enrich the clinical implication of integrated coronary physiology and may help predict prognosis.





Coronary Flow Measurements in Clinical Practice: The Waves Are There, The Wind Is Calling




Influence of Microcirculatory Dysfunction on Angiography-Based Functional Assessment of Coronary Stenoses
AbstractObjectives

The authors sought to evaluate the influence of coronary microcirculatory dysfunction (CMD) on the diagnostic performance of the quantitative flow ratio (QFR).

Background

Functional angiographic assessment of coronary stenoses based on fluid dynamics, such as QFR, constitutes an attractive alternative to fractional flow reserve (FFR). However, it is unknown whether CMD affects the reliability of angiography-based functional indices.

Methods

FFR and the index of microcirculatory resistance (IMR) were measured in 300 vessels (248 patients) as part of a multicenter international registry. QFR was calculated at a blinded core laboratory. Vessels were classified into 2 groups according to microcirculatory status: low IMR (<23 U), and high IMR (≥23 U, CMD). The impact of CMD on the diagnostic performance of QFR, as well as on incremental value of QFR over quantitative angiography, was assessed using FFR as reference.

Results

Percent diameter stenosis (%DS) and FFR were similar in low- and high-IMR groups (%DS 51 ± 12% vs. 53 ± 11%; p = 0.16; FFR 0.80 ± 0.11 vs. 0.81 ± 0.11; p = 0.23, respectively). In the overall cohort, classification agreement (CA) between QFR and FFR and diagnostic efficiency of QFR (area under the receiver-operating characteristics curve [AUC]) were high (CA: 88%; AUC: 0.93 [95% confidence interval (CI): 0.90 to 0.96]). However, when assessed according to microcirculatory status, a significantly lower CA and AUC of QFR were found in the high-IMR group as compared with the low-IMR group (CA: 76% vs. 92%; p < 0.001; AUC: 0.88 [95% CI: 0.79 to 0.94] vs. 0.96 [95% CI: 0.92 to 0.98]; p < 0.05). Compared with angiographic assessment, QFR increased by 0.20 (p < 0.001) and by 0.16 (p < 0.001) the AUC of %DS in low- and high-IMR groups, respectively. Independent predictors of misclassification between QFR and FFR were high IMR and acute coronary syndrome.

Conclusions

CMD decreases the diagnostic performance of QFR. However, even in the presence of CMD, QFR remains superior to angiography alone in ascertaining functional stenosis severity.





A Song of Pressure and Flow, or There and Back Again




Pre-Angioplasty Instantaneous Wave-Free Ratio Pullback Predicts Hemodynamic Outcome In Humans With Coronary Artery Disease: Primary Results of the International Multicenter iFR GRADIENT Registry
AbstractObjectives

The authors sought to evaluate the accuracy of instantaneous wave-Free Ratio (iFR) pullback measurements to predict post-percutaneous coronary intervention (PCI) physiological outcomes, and to quantify how often iFR pullback alters PCI strategy in real-world clinical settings.

Background

In tandem and diffuse disease, offline analysis of continuous iFR pullback measurement has previously been demonstrated to accurately predict the physiological outcome of revascularization. However, the accuracy of the online analysis approach (iFR pullback) remains untested.

Methods

Angiographically intermediate tandem and/or diffuse lesions were entered into the international, multicenter iFR GRADIENT (Single instantaneous wave-Free Ratio Pullback Pre-Angioplasty Predicts Hemodynamic Outcome Without Wedge Pressure in Human Coronary Artery Disease) registry. Operators were asked to submit their procedural strategy after angiography alone and then after iFR-pullback measurement incorporating virtual PCI and post-PCI iFR prediction. PCI was performed according to standard clinical practice. Following PCI, repeat iFR assessment was performed and the actual versus predicted post-PCI iFR values compared.

Results

Mean age was 67 ± 12 years (81% male). Paired pre- and post-PCI iFR were measured in 128 patients (134 vessels). The predicted post-PCI iFR calculated online was 0.93 ± 0.05; observed actual iFR was 0.92 ± 0.06. iFR pullback predicted the post-PCI iFR outcome with 1.4 ± 0.5% error. In comparison to angiography-based decision making, after iFR pullback, decision making was changed in 52 (31%) of vessels; with a reduction in lesion number (–0.18 ± 0.05 lesion/vessel; p = 0.0001) and length (–4.4 ± 1.0 mm/vessel; p < 0.0001).

Conclusions

In tandem and diffuse coronary disease, iFR pullback predicted the physiological outcome of PCI with a high degree of accuracy. Compared with angiography alone, availability of iFR pullback altered revascularization procedural planning in nearly one-third of patients.





Instantaneous Wave-Free Ratio Pressure Pullback With Virtual Percutaneous Coronary Intervention Planning: Seeing the Future of Coronary Interventions?




Incidence, Predictors, and Clinical Impact of Prosthesis-Patient Mismatch Following Transcatheter Aortic Valve Replacement in Asian Patients: The OCEAN-TAVI Registry
AbstractObjectives

The authors sought to investigate the prevalence, risk factors, and mid-term mortality in Asian patients with prosthesis–patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR).

Background

Little information is available on PPM after TAVR in Asian patients.

Methods

The authors included 1,558 patients enrolled in the OCEAN-TAVI (Optimized transCathEter vAlvular iNtervention) Japanese multicenter registry from October 2013 to July 2016 after excluding patients who died following TAVR before discharge. PPM was defined as moderate if greater double equals0.65 but less double equals0.85 cm2/m2, or severe if <0.65 cm2/m2 at the indexed effective orifice area by post-procedural echocardiography.

Results

Of the 1,546 patients, moderate and severe PPM were observed in 138 (8.9%) and 11 (0.7%) patients, respectively. These 149 patients were included in the PPM group. The median age and body surface area were 85 years (interquartile range [IQR]: 81 to 88 years) and 1.41 m2 (IQR: 1.30 to 1.53 m2), respectively. In our multivariate analysis, younger age, larger body surface area, smaller aortic valve area, smaller annulus area, no balloon post-dilatation, and use of Edwards Sapien 3 (Edwards Lifesciences, Irvine, California) were identified as independent predictors of PPM. The estimated cumulative all-cause mortality at 1 year using the Kaplan-Meier method was similar between the PPM and non-PPM groups (10.2% vs. 8.3%; log-rank; p = 0.41).

Conclusions

The low prevalence of PPM and mortality at 1 year in patients with PPM after TAVR in this Japanese cohort implies that PPM is not a risk factor for mid-term mortality in Asian patients who have undergone TAVR.





Patient-Prosthesis Mismatch After Aortic Valve Intervention: Another Win for Transcatheter Aortic Valve Replacement




Coronary Sinus Reducer Implantation for the Treatment of Chronic Refractory Angina: A Single-Center Experience
AbstractObjectives

The aim of this study was to assess the safety and efficacy of the Reducer in a real-world cohort of patients presenting with refractory angina.

Background

The coronary sinus Reducer is a novel device to aid in the management of patients with severe angina symptoms refractory to optimal medical therapy and not amenable to further revascularization.

Methods

Fifty patients with refractory angina and objective evidence of myocardial ischemia who were judged unsuitable for revascularization were treated with coronary sinus Reducer implantation at a single center between March 2015 and August 2016. Safety endpoints were procedural success and the absence of device-related adverse events. Efficacy endpoints, assessed at 4- and 12-month follow-up, were a reduction in Canadian Cardiovascular Society angina class, improvement in quality of life assessed using the Seattle Angina Questionnaire, improvement in exercise tolerance assessed using the 6-min walk test, and reduction in pharmacological antianginal therapy.

Results

Procedural success was achieved in all patients, with no device-related adverse effects during the procedure or at follow-up. Regarding the efficacy endpoint, 40 patients (80%) had at least 1 reduction in Canadian Cardiovascular Society class, and 20 patients (40%) had at least 2 class reductions, with a mean class reduction to 1.67 ± 0.83 vs. 2.98 ± 0.52 (p < 0.001) at 4-month follow-up. All Seattle Angina Questionnaire items improved significantly (p < 0.001 for all). A significant increment in 6-min walk distance to 388.6 ± 119.7 m vs. 287.0 ± 138.9 m (p = 0.004) was observed. Sixteen patients (32%) and 3 patients (6%) demonstrated reductions of at least 1 or 2 antianginal drugs, respectively. The benefit of Reducer implantation observed at 4-month follow-up was maintained at 1 year.

Conclusions

In this real-world, single-center experience, implantation of the coronary sinus Reducer appeared safe and was associated with reduction in anginal symptoms and improvement in quality of life in patients with refractory angina who were not candidates for further revascularization.





New Treatment Options for the "No Option" Patient With Refractory Angina




Long-Term Outcomes After Percutaneous Closure of Ostium Secundum Atrial Septal Defect in the Young: A Nationwide Cohort Study
AbstractObjectives

This study sought to assess procedural characteristics, early clinical outcome, and long-term complications after transcatheter closure of atrial septal defect (ASD) in children.

Background

Transcatheter closure has become the preferred strategy in most cases of isolated secundum ASD. However, reported experience in the pediatric population is limited.

Methods

A 1998 to 2016 retrospective multicenter study was performed in 9 French tertiary institutions. All children who had an attempt of percutaneous ASD closure with an Amplatzer Septal Occluder were included.

Results

In 1,326 children (39% males; median age, 9 years [0.7 to 18]; weight, 29 kg [3.6 to 92]), transcatheter ASD closure was performed. Median ASD size was 15 mm (3 to 41); 254 (19.1%) patients had a large ASD (≥20 mm/m2). Procedural success rate was 95.3% (95% confidence interval: 93.9% to 96.3%). No death was observed but periprocedural complications occurred in 24 patients (1.8%). After a median follow-up of 3.5 years (range 6 months to 18 years; 173 patients [13%] followed >10 years), delayed major complications were minimal (n = 12; 1.04%) including no death and/or cardiac erosion. Periprocedural and delayed complications rates were significantly higher in children ≤15 kg (5.2% vs. 1.5%; p = 0.007 and 3.1% vs. 0.7%; p < 0.007, respectively) and those with large ASD (3.5% vs. 1.4%; p = 0.008 and 1.7% vs. 0.7%; p = 0.052, respectively).

Conclusions

Transcatheter ASD closure using Amplatzer Septal Occluder is safe in children with a minimal rate of periprocedural complications and a favorable long-term outcome, especially with no death or cardiac erosion despite a substantial proportion of large defects. Children ≤15 kg and those with large ASDs had a greater risk of complications.





Outcomes After Device Closure of Atrial Septal Defect in Children: The Present Is Good, Is the Future Brighter?




Transcatheter Mitral Valve Replacement After Transcatheter Electrosurgical Laceration of Alfieri STItCh (ELASTIC): First-in-Human Report




3-Dimensional-Printed Model for Planning Transcatheter Mitral Valve Replacement




The National Inpatient Sample Is Not an Appropriate Database to Assess the Incidence of Spontaneous Coronary Artery Dissection




Reply: The National Inpatient Sample Is Not an Appropriate Database to Assess the Incidence of Spontaneous Coronary Artery Dissection




Percutaneous Closure of Patent Foramen Ovale in Migraine: A Meta-Analysis of Randomized Clinical Trials




Feasibility and Outcomes of Repeat Percutaneous Edge-to-Edge Mitral Valve Repair Procedures in Patients at High Risk for Surgery




Contrast-Zero Transcatheter Aortic Valve Replacement for Patients With Severe Renal Dysfunction: A Single-Center Experience




Optimal Approach for Uncrossable Stent Restenosis: Laser and Rotational Atherectomy Assessed by 3-Dimensional Optical Coherence Tomography




Pseudo-Cor Triatriatum Dextrum: A Rare Manifestation of Aorto-Right Atrial Fistula Successfully Closed by Amplatzer Vascular Plug




Clipping the Ring: Transcatheter Edge-to-Ring Mitral Valve Repair in a Patient With Prior Mitral Annuloplasty Ring




Update in the Percutaneous Management of Coronary Chronic Total Occlusions
Abstract

Percutaneous coronary intervention (PCI) for chronic total occlusions (CTOs) has been rapidly evolving during recent years. With improvement in equipment and techniques, high success rates can be achieved at experienced centers, although overall success rates remain low. Prospective, randomized-controlled data regarding optimal use and indications for CTO PCI remain limited. CTO PCI should be performed when the anticipated benefit exceeds the potential risk. New high-quality studies of the clinical outcomes and techniques of CTO PCI are needed, as is the expansion of expert centers and operators that can achieve excellent clinical outcomes in this challenging patient and lesion subgroup. In the current review the authors summarize the latest publications in CTO PCI and provide an overview of the current state of the field.





Effect of Procedure and Coronary Lesion Characteristics on Clinical Outcomes Among Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention: Insights From the PIONEER AF-PCI Trial
AbstractObjectives

This study sought to assess whether there were significant interactions of procedural access strategies and lesion characteristics with bleeding and ischemic events among atrial fibrillation (AF) patients anticoagulated with rivaroxaban or warfarin following a percutaneous coronary intervention.

Background

Among stented AF patients, the impact of procedural access strategies or lesion characteristics on antithrombotic safety and efficacy outcomes is unclear.

Methods

In the PIONEER AF-PCI (An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention) trial, 2,124 patients were randomized to 3 groups and followed for 12 months: 1) rivaroxaban 15 mg once daily plus a P2Y12 inhibitor (n = 709); 2) rivaroxaban 2.5 mg twice a day plus dual antiplatelet therapy (DAPT) (n = 709); and 3) dose-adjusted warfarin plus DAPT (n = 706). Kaplan-Meier rates of clinically significant bleeding and major adverse cardiovascular events were compared between treatments stratified by subgroups of procedure type and lesion characteristics.

Results

Compared with warfarin, both rivaroxaban regimens consistently reduced clinically significant bleeding across subgroups of radial versus femoral arterial access and by vascular closure device use. Treatment effect of rivaroxaban on major adverse cardiovascular events did not vary when stratified by ischemia-driven revascularization, urgency of revascularization, location of culprit artery, presence of bifurcation lesion, presence of thrombus, type, and length of stent or number of stents (interaction p > 0.05 for all subgroups).

Conclusions

Among stented AF patients requiring long-term oral anticoagulation, there was no effect modification by procedure or lesion characteristics of either clinically significant bleeding or major adverse cardiovascular events. Rivaroxaban-based therapy was superior to warfarin plus DAPT in bleeding outcomes regardless of the type of stent or arterial access during the index coronary revascularization. (A Study Exploring Two Strategies of Rivaroxaban [JNJ39039039; BAY-59-7939] and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention [PIONEER AF-PCI]; NCT01830543)





Is it Time to Abandon Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With Atrial Fibrillation on Anticoagulation?




Clinical, Angiographic, and Procedural Correlates of Very Late Absorb Scaffold Thrombosis: Multistudy Registry Results
AbstractObjectives

The aim of this study was to identify independent correlates of very late scaffold thrombosis (VLST) from an analysis of consecutively treated patients from 15 multicenter studies.

Background

Recent analyses suggest an increased risk for VLST with the Absorb Bioresorbable Vascular Scaffold compared with drug-eluting stents, but insights as to correlates of risk are limited.

Methods

A total of 55 patients were identified with scaffold thrombosis. They were matched 2:1 with control subjects selected randomly from patients without thrombosis from the same study. Quantitative coronary angiography was available for 96.4% of patients. Multiple logistic and Cox regression analysis were used to identify significant independent outcome correlates from 6 pre-specified characteristics.

Results

Patients had scaffold thrombosis at a median of 20 months (interquartile range: 17 to 27 months). Control subjects were followed for 36 months (interquartile range: 24 to 38 months). For the combined groups, reference vessel diameter (RVD) was 2.84 ± 0.50 mm, scaffold length was 26 ± 16 mm, and post-dilatation was performed in 56%. Univariate correlates of thrombosis were smaller nominal scaffold/RVD ratio (linear p = 0.001; ratio <1.18:1; odds ratio: 7.5; p = 0.002) and larger RVD (linear p = 0.001; >2.72 mm; odds ratio: 3.4; p = 0.001). Post-dilatation at ≥16 atm, post-dilatation balloon/scaffold ratio, final percentage stenosis, and dual antiplatelet therapy were not correlated with VLST. Only scaffold/RVD ratio remained a significant independent correlate of VLST (p = 0.001), as smaller ratio was correlated with RVD (p < 0.001). Post hoc analysis of 8 other potential covariates revealed no other correlates of outcome.

Conclusions

In the present analysis, the largest to date of its type, relative scaffold undersizing was the strongest determinant of VLST. Given current understanding of "scaffold dismantling," this finding likely has ramifications for all bioresorbable scaffolds.





Bioresorbable Vascular Scaffolds: Back to the Drawing Board




Bioresorbable Scaffold for Treatment of Coronary Artery Lesions: Intravascular Ultrasound Results From the ABSORB Japan Trial
AbstractObjectives

The aim of this study was to characterize post-procedural intravascular ultrasound (IVUS) findings in the ABSORB Japan trial, specifically stratified by the size of target coronary arteries.

Background

Despite overall noninferiority confirmed in recent randomized trials comparing bioresorbable vascular scaffolds (BVS) (Absorb BVS) and cobalt-chromium everolimus-eluting metallic stents (CoCr-EES), higher event rates of Absorb BVS have been reported with suboptimal deployment, especially in small coronary arteries.

Methods

In the ABSORB Japan trial, 150 patients (2:1 randomization) were scheduled in the IVUS cohort. Small vessel was defined as mean reference lumen diameter <2.75 mm. Tapered-vessel lesions were defined as tapering index (proximal/distal reference lumen diameter) ≥1.2.

Results

Overall, IVUS revealed that the Absorb BVS arm had smaller device expansion than the CoCr-EES arm did, which was particularly prominent in small- and tapered-vessel lesions. Higher tapering index was also associated with higher rates of incomplete strut apposition in Absorb BVS, but not in CoCr-EES. With respect to procedural techniques, small-vessel lesions were treated more frequently with noncompliant balloons at post-dilatation but using significantly lower pressure in the Absorb BVS arm. In contrast, tapered-vessel lesions were post-dilated at equivalent pressure but with significantly smaller balloon catheters in the Absorb BVS arm, compared with the CoCr-EES arm.

Conclusions

The significantly smaller device expansion especially in small vessels may account for the poorer outcomes of Absorb BVS in this lesion type. Appropriate optimization strategy, possibly different between polymeric and metallic devices, needs to be established for bioresorbable scaffold technology. (AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 Absorb™ BVS) in Japanese Population [ABSORB JAPAN]; NCT01844284)





Why Do We Still Tolerate "Suboptimal Deployment"?




Burden of 30-Day Readmissions After Percutaneous Coronary Intervention in 833,344 Patients in the United States: Predictors, Causes, and Cost: Insights From the Nationwide Readmission Database
AbstractObjectives

This study aimed to examine the 30-day unplanned readmissions rate, predictors of readmission, causes of readmissions, and clinical impact of readmissions after percutaneous coronary intervention (PCI).

Background

Unplanned rehospitalizations following PCI carry significant burden to both patients and the local health care economy and are increasingly considered as an indicator of quality of care.

Methods

Patients undergoing PCI between 2013 and 2014 in the U.S. Nationwide Readmission Database were included. Incidence, predictors, causes, and cost of 30-day unplanned readmissions were determined.

Results

A total of 833,344 patients with PCI were included, of whom 77,982 (9.3%) had an unplanned readmission within 30 days. Length of stay for the index PCI was greater (4.7 vs. 3.9 days) and mean total hospital cost ($23,211 vs. $37,524) was higher for patients who were readmitted compared with those not readmitted. The factors strongly independently associated with readmissions were index hospitalization discharge against medical advice (odds ratio [OR]: 1.91; 95% confidence interval [CI]: 1.65 to 2.22), transfer to short-term hospital for inpatient care (OR: 1.62; 95% CI: 1.38 to 1.90), discharge to care home (OR: 1.57; 95% CI: 1.51 to 1.64), and chronic kidney disease (OR: 1.50; 95% CI: 1.44 to 1.55). Charlson Comorbidity Index score (OR: 1.28; 95% CI: 1.27 to 1.29) and number of comorbidities (OR: 1.18; 95% CI: 1.17 to 1.18) were independently associated with unplanned readmission. The majority of readmissions were due to noncardiac causes (56.1%).

Conclusions

Thirty-day readmissions after PCI are relatively common and relate to baseline comorbidities and place of discharge. More than one-half of the readmissions were due to noncardiac causes.





Percutaneous Coronary Intervention Readmissions: Where Are the Solutions?




Transcatheter Laceration of Aortic Leaflets to Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement: Concept to First-in-Human
AbstractObjectives

This study sought to develop a novel technique called bioprosthetic or native aortic scallop intentional laceration to prevent coronary artery obstruction (BASILICA).

Background

Coronary artery obstruction is a rare but fatal complication of transcatheter aortic valve replacement (TAVR).

Methods

We lacerated pericardial leaflets in vitro using catheter electrosurgery, and tested leaflet splaying after benchtop TAVR. The procedure was tested in swine. BASILICA was then offered to patients at high risk of coronary obstruction from TAVR and ineligible for surgical aortic valve replacement. BASILICA used marketed devices. Catheters directed an electrified guidewire to traverse and lacerate the aortic leaflet down the center line. TAVR was performed as usual.

Results

TAVR splayed lacerated bovine pericardial leaflets. BASILICA was successful in pigs, both to left and right cusps. Necropsy revealed full length lacerations with no collateral thermal injury. Seven patients underwent BASILICA on a compassionate basis. Six had failed bioprosthetic valves, both stented and stent-less. Two had severe aortic stenosis, including 1 patient with native disease, 3 had severe aortic regurgitation, and 2 had mixed aortic valve disease. One patient required laceration of both left and right coronary cusps. There was no hemodynamic compromise in any patient following BASILICA. All patients had successful TAVR, with no coronary obstruction, stroke, or any major complications. All patients survived to 30 days.

Conclusions

BASILICA may durably prevent coronary obstruction from TAVR. The procedure was successful across a range of presentations, and requires further evaluation in a prospective trial. Its role in treatment of degenerated TAVR devices remains untested.





Tearing Down the Risk for Coronary Obstruction With Transcatheter Aortic Valve Replacement




Prevalence and Outcomes of Mitral Stenosis in Patients Undergoing Transcatheter Aortic Valve Replacement: Findings From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry
AbstractObjectives

This study sought to examine the prevalence of mitral stenosis (MS) and its impact on in-hospital and 1-year clinical outcomes among patients undergoing transcatheter aortic valve replacement (TAVR).

Background

Patients with coexisting severe aortic stenosis and MS are increasingly being considered for TAVR.

Methods

The study cohort included 44,755 patients (age ≥18 years) who underwent TAVR during November 1, 2011, to September 30, 2015, and were registered in Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies (TVT) Registry. One-year outcomes were assessed by linking TVT registry data of this cohort to patient-specific Centers for Medicare & Medicaid Services administrative claims data (n = 31,453). The primary outcome was the composite of death, stroke, heart failure–related hospitalization, and mitral valve intervention at 1 year.

Results

MS was present in 11.6% of cohort (mean age, 82 years; 52% males), being severe in 2.7%. Severe MS was associated with higher in-hospital mortality rates (5.6% vs. 3.9% for nonsevere MS and 4.1% for no MS; p = 0.02). In contrast to those without MS, severe MS group had significantly higher risk for the primary outcome, mortality (1 year), and heart failure–related hospitalization (1 year) (adjusted hazard ratio: 1.2 [95% confidence interval (CI): 1.1 to 1.4], 1.2 [95% CI: 1.0 to 1.4], and 1.3 [95% CI: 1.1 to 1.5], respectively; p < 0.05 for all).

Conclusions

Approximately one-tenth of patients undergoing TAVR have concomitant MS. Severe MS is an independent predictor of 1-year adverse clinical outcomes following TAVR. The higher risk for long-term adverse events must be considered when evaluating patients with combined aortic stenosis and MS for TAVR.





Combined Severe Aortic and Mitral Stenoses: An Expanding Potential for Transcatheter Therapies?




Transseptal Retrieval of Dislodged Left Atrial Appendage Occlusion Device From the Left Ventricle




Optical Coherence Tomographic Image Pattern of Metallic Bioresorbable Vascular Scaffold Restenosis




The Presence of a CTO in a Non-Infarct-Related Artery During a STEMI Treated With Contemporary Primary PCI Is Associated With Increased Rates of Early and Late Cardiovascular Morbidity and Mortality: The CTO-TOTAL Substudy




Morphological Patterns of In-Stent Chronic Total Occlusions: An Intravascular Ultrasound Study




Is There Light at the End of the Thin-Strut Tunnel?: In Vitro Insights on Strut Thickness Impact on Thrombogenicity in Bioresorbable Stents or Scaffolds




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