Autopsy studies have identified delayed healing and lack of endothelialization of DES struts as the hallmarks of LST. DES strut coverage has not previously been examined in vivo in patients with LST.

We studied 54 patients, including 18 with DES LST (median 615 days after implant) undergoing emergent percutaneous coronary interventions and 36 matched DES control subjects undergoing routine repeat OCT and intravascular ultrasound (IVUS) who did not experience LST for ≥3 years. Thrombus aspiration was performed during emergent percutaneous coronary intervention before OCT and IVUS assessment.

By OCT, patients with LST—compared with control subjects—had a higher percentage of uncovered (median [interquartile range]) (12.27 [5.50 to 23.33] vs. 4.14 [3.00 to 6.22], p < 0.001) and malapposed (4.60 [1.85 to 7.19] vs. 1.81 [0.00 to 2.99], p < 0.001) struts. The mean neointimal thickness was similar in the 2 groups (0.23 ± 0.17 mm vs. 0.17 ± 0.09 mm, p = 0.28). By IVUS, stent expansion was comparable in the 2 groups, although positive remodeling was increased in patients with LST (mean vessel cross-section area 19.4 ± 5.8 mm² vs. 15.1 ± 4.6 mm², p = 0.003). Thrombus aspiration demonstrated neutrophils and eosinophils in most cases. By multivariable analysis, the length of segment with uncovered stent struts by OCT and the remodeling index by IVUS were independent predictors of LST.

In this in vivo case-controlled study, the presence of uncovered stent struts as assessed by OCT and positive vessel remodeling as imaged by IVUS were associated with LST after DES.

Bleeding and consequent blood product transfusions have been causally associated with a higher mortality rate in patients with myocardial infarction undergoing coronary angioplasty.

We identified all adults undergoing percutaneous intervention for acute myocardial infarction in Emilia-Romagna, a region in the north of Italy of 4 million residents, between January 1, 2003, and July 30, 2009, at 12 referral hospitals using a region-mandated database of percutaneous coronary intervention procedures. Differences in the risk of death at 2 years between patients undergoing transfemoral versus transradial intervention, assessed on an intention-to-treat basis, were determined from vital statistics records and compared based on propensity score adjustment and matching.

A total of 11,068 patients were treated for acute myocardial infarction (8,000 via transfemoral and 3,068 via transradial route). According to analysis of matched pairs, the 2-year, risk-adjusted mortality rates were lower for the transradial than for the transfemoral group (8.8% vs. 11.4%; p = 0.0250). The rate of vascular complications requiring surgery or need for blood transfusion were also significantly decreased in the transradial group (1.1% vs. 2.5%, p = 0.0052).

In patients undergoing angioplasty for acute myocardial infarction, transradial treatment is associated with decreased 2-year mortality rates and a reduction in the need for vascular surgery and/or blood transfusion compared with transfemoral intervention.

The number of vascular access complications in the published data ranges from 5% to 38% after transradial catheterization.

Between November 2009 and August 2010, 455 patients 65.3 ± 10.9 years of age (62.2% male) with transradial access with 5-F (n = 153) or 6-F (n = 302) arterial sheaths were prospectively recruited. Duplex sonography was obtained in each patient before discharge. Patients with symptomatic RAO were treated with low-molecular-weight heparin (LMWH), and a follow-up was performed.

The incidence of access site complications was 14.4% with 5-F sheaths compared with 33.1% with 6-F sheaths (p < 0.001). Radial artery occlusion occurred in 13.7% with 5-F sheaths compared with 30.5% with 6-F sheaths (p < 0.001). There was no difference between groups with regard to hemorrhage, pseudoaneurysms, or arteriovenous fistulas. Female sex, larger sheath size, peripheral arterial occlusive disease, and younger age independently predicted RAO in multivariate analysis. In total, 42.5% of patients with RAO were immediately symptomatic; another 7% became symptomatic within a mean of 4 days. Of patients with RAO, 59% were treated with LMWH. The recanalization rates were significantly higher in patients receiving LMWH compared with conventional therapy (55.6% vs. 13.5%, p < 0.001) after a mean of 14 days.

The incidence of RAO by vascular ultrasound was higher than expected from previous data, especially in patients who underwent the procedure with larger sheaths.

In bifurcation stenting practice, it is still controversial how post-dilation should be performed and whether the kissing balloon (KB) technique is mandatory when only the main vessel (MV) receives a stent.

A series of drug-eluting stents (DES) (n = 26) were deployed in a coronary bifurcation model following a provisional approach. After the deployment of the stent in the MV, post-dilation with the KB technique was compared with a 2-step, sequential post-dilation of the side branch (SB) and MV without kissing.

The percentage of the SB lumen area free of stent struts was similar after KB (79.1 ± 8.7%) and after the 2-step sequence (74.4 ± 11.6%, p = 0.25), a considerable improvement compared with MV stenting only without dilation of the stent at the SB ostium (30.8 ± 7.8%, p < 0.0001). The rate of strut malapposition in the ostium was 21.3 ± 9.2% after KB and 24.9 ± 10.4% after the 2-step sequence, respectively, a significant reduction compared with a simple SB dilation (55.3 ± 16.8%, p < 0.0001) or MV stenting only (47.0 ± 8.5%, p < 0.0005). KB created a significant elliptical overexpansion of the MV lumen, inducing higher stress concentration proximal to the SB. KB also led to a higher risk of incomplete stent apposition at the proximal stent edge (30.7 ± 26.4% vs. 2.8 ± 9.6% for 2-step, p = 0.0016).

Sequential 2-step post-dilation of the SB and MV may offer a simpler and more efficient alternative to final KB technique for provisional stenting of bifurcations.

The development of drug-eluting stents has made it increasingly feasible to treat bifurcation lesions percutaneously. However, ST at coronary bifurcations may be associated with greater mortality than ST elsewhere.

We analyzed a multicenter California registry comprising all cases of angiographic definite ST at 5 academic hospitals from 2005 to 2010. Stenting was defined as occurring at a bifurcation if the main vessel stent crossed a side branch ≥2.0 mm in diameter (provisional single-stent approach), or if there was a prior 2-stent bifurcation approach.

Among 173 cases of angiographic definite ST, we identified 20 cases of ST at coronary bifurcations. Nine of 20 bifurcation ST (45%) occurred with a stent present in both the parent and branch vessel. Eight cases had thrombus present in both the parent and side branch vessels. In-hospital mortality was much higher for subjects with bifurcation ST than ST at a nonbifurcation site (20% vs. 2%, p < 0.0001). During a median follow-up of 2.3 years, ST at a coronary bifurcation was associated with increased long-term mortality (hazard ratio [HR]: 3.3, 95% confidence interval [CI]: 1.4 to 7.7, p = 0.007) and a significantly higher risk for major adverse cardiovascular events (HR: 2.2, 95% CI: 1.04 to 4.8, p = 0.04) relative to ST at a nonbifurcation site.

ST at coronary bifurcations is associated with a higher in-hospital and long-term mortality than ST at nonbifurcation lesions. (Stent Thrombus in Acute Coronary Syndromes; NCT00931502)

There is paucity of consistent data on DES for the treatment of ISR, especially, DES ISR.

The e-SELECT (Multicenter Post-Market Surveillance) registry is a Web-based, multicenter and international registry encompassing virtually all subsets of patients and lesions treated with at least 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis all patients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint was major adverse cardiac events and stent thrombosis rate at 1 year.

Of 15,147 patients enrolled, 1,590 (10.5%) presented at least 1 ISR (BMS group, n = 1,235, DES group, n = 355). Patients with DES ISR had higher incidence of diabetes (39.4% vs. 26.9%, p < 0.001), renal insufficiency (5.8% vs. 2.3%, p = 0.003), and prior coronary artery bypass graft (20.5% vs. 11.8%, p < 0.001). At 1 year, death (1.4% for BMS vs. 2.1% for DES, p = 0.3) and myocardial infarction (2.4% for BMS and 3.3% for DES, p = 0.3) rates were similar, whereas ischemia-driven target lesion revascularization and definite/probable late stent thrombosis were higher in patients with DES ISR (6.9% vs. 3.1%, p = 0.003, and 1.8% vs. 0.5%, p = 0.04, respectively).

Use of SES for either BMS or DES ISR treatment is safe and associated with low target lesion revascularization recurrence and no apparent safety concern.

Transcutaneous aortic valve insertion is a fundamentally new procedure for the treatment of aortic valve stenosis. The number of cases needed to gain proficiency with concomitant ease and familiarity (i.e., the "learning curve") with the procedure is unknown.

We performed a retrospective analysis of the first 44 consecutive patients who underwent transcatheter aortic valve implantation as part of the PARTNER (Placement of Aortic Transcatheter Valves) trial at our institution between November 2008 and May 2011.

The median age of the patients was 83 years (interquartile range: 77 to 87 years) and a median Society of Thoracic Surgery risk score of 9.6. Pre-procedural assessment of the aortic valve revealed a mean gradient of 53.5 mm Hg, mean aortic valve area of 0.7 mm², and a median ejection fraction of 59.5%. Patients were divided into tertiles based on sequence. Significant decreases in median contrast volume (180 to 160 to 130 ml, p = 0.003), valvuloplasty to valve deployment time (12.0 to 11.6 to 7.0 min, p < 0.001) and fluoroscopy times, from 26.1 to 17.2 and 14.3 min occurred from tertiles 1 to 3, p < 0.001. Significant decreases in radiation doses were also seen across the 3 tertiles, p < 0.001. The 30-day mortality for the entire cohort was 11%.

Experience accumulated over 44 transfemoral aortic valve implantations led to significant decreases in procedural times, radiation, and contrast volumes. Our data show increasing proficiency with evidence of plateau after the first 30 cases. More studies are needed to confirm these findings.

The impact of learning on the clinical outcomes complicates the assessment of the safety and efficacy during the early experience with newly introduced medical devices.

We performed a retrospective analysis of the relationship between cumulative institutional experience and clinical device success, defined as device deployment success and freedom from any vascular complications, for the StarClose vascular closure device (Abbott Vascular, Redwood City, California). Generalized estimating equation modeling was used to develop risk-adjusted clinical success predictions that were analyzed to quantify learning curve rates.

A total of 107,710 procedures used at least 1 StarClose deployment, between January 1, 2006, and December 31, 2007, with overall clinical success increasing from 93% to 97% during the study period. The learning curve was triphasic, with an initial rapid learning phase, followed by a period of declining rates of success, followed finally by a recovery to a steady-state rate of improved device success. The rates of learning were influenced positively by diagnostic (vs. percutaneous coronary intervention) procedure use and teaching status and were affected inversely by annual institutional volume.

An institutional-level learning curve for the initial national experience of StarClose was triphasic, likely indicating changes in patient selection and expansion of number of operators during the initial phases of device adoption. The rate of learning was influenced by several institutional factors, including overall procedural volume, utilization for percutaneous coronary intervention procedures, and teaching status.

CIN is a frequent cause of acute kidney injury associated with increased morbidity and mortality.

A total of 170 consecutive patients with chronic kidney disease (CKD) undergoing coronary procedures were randomized to either furosemide with matched hydration (FMH group, n = 87) or to standard intravenous isotonic saline hydration (control group; n = 83). The FMH group received an initial 250-ml intravenous bolus of normal saline over 30 min followed by an intravenous bolus (0.5 mg/kg) of furosemide. Hydration infusion rate was automatically adjusted to precisely replace the patient's urine output. When a urine output rate >300 ml/h was obtained, patients underwent the coronary procedure. Matched fluid replacement was maintained during the procedure and for 4 h post-treatment. The definition of CIN was a ≥25% or ≥0.5 mg/dl rise in serum creatinine over baseline.

In the FMH group, no device- or therapy-related complications were observed. Four (4.6%) patients in the FMH group developed CIN versus 15 (18%) controls (p = 0.005). A lower incidence of cumulative in-hospital clinical complications was also observed in FMH-treated patients than in controls (8% vs. 18%; p = 0.052).

In patients with CKD undergoing coronary procedures, furosemide-induced high urine output with matched hydration significantly reduces the risk of CIN and may be associated with improved in-hospital outcome.

(Induced Diuresis With Matched Hydration Compared to Standard Hydration for Contrast Induced Nephropathy Prevention [MYTHOS]; NCT00702728)

The role of NAC in the prevention of contrast-induced nephropathy (CIN) is controversial, leading to widely varying recommendations for its use.

Use of NAC was assessed in consecutive patients undergoing nonemergent percutaneous coronary intervention from 2006 to 2009 in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium, a large multicenter quality improvement collaborative. We examined the overall prevalence of NAC use in these patients and then used propensity matching to link its use with clinical outcomes, including CIN, nephropathy-requiring dialysis, and death.

Of the 90,578 percutaneous coronary interventions performed during the study period, NAC was used in 10,574 (11.6%) procedures, with its use steadily increasing over the study period. Patients treated with NAC were slightly older and more likely to have baseline renal insufficiency and other comorbidities. In propensity-matched, risk-adjusted models, we found no differences in outcomes between patients treated with NAC and those not receiving NAC for CIN (5.5% vs. 5.5%, p = 0.99), nephropathy-requiring dialysis (0.6% vs. 0.6%, p = 0.69), or death (0.6% vs. 0.8%, p = 0.15). These findings were consistent across many prespecified subgroups.

Use of NAC is common and has steadily increased over the study period but does not seem to be associated with improved clinical outcomes in real-world practice.

MV repair for mitral regurgitation (MR) can be accomplished by use of a clip that approximates the free edges of the mitral leaflets.

All patients were declined for surgery because of a high logistic EuroSCORE (>20%) or the presence of other specific surgical risk factors. Transthoracic echocardiography was performed before and 6 months after the procedure. Differences in New York Heart Association (NYHA) functional class, quality of life (QoL) using the Minnesota questionnaire, and 6-min walk test (6-MWT) distances were reported.

Fifty-five procedures were performed in 52 patients (69.2% male, age 73.2 ± 10.1 years, logistic EuroSCORE 27.1 ± 17.0%). In 3 patients, partial clip detachment occurred; a second clip was placed successfully. One patient experienced cardiac tamponade. Two patients developed inguinal bleeding, of whom 1 needed surgery. Six patients (11.5%) died during 6-month follow-up (5 patients as a result of progressive heart failure and 1 noncardiac death). The MR grade before repair was ≥3 in 100%; after 6 months, a reduction in MR grade to ≤2 was present in 79% of the patients. Left ventricular (LV) end-diastolic diameter, LV ejection fraction, and systolic pulmonary artery pressure improved significantly. Accompanied improvements in NYHA functional class, QoL index, 6-MWT distances, and log N-terminal pro–B-type natriuretic peptide were observed.

In a high-risk population, MR reduction can be achieved by percutaneous edge-to-edge valve repair, resulting in LV remodeling with improvement of functional capacity after 6 months.

This study sought to compare the neointimal response of metallic everolimus drug-eluting stents (DES) and polymeric everolimus bioresorbable vascular scaffolds (BVS) by optical coherence tomography at 1 year.

DES decrease the risk of restenosis by reducing the neointimal response. However, DES may impair strut coverage, and this has been associated with late stent/scaffold thrombosis. BVS may overcome the risk of stent/scaffold thrombosis when completely resorbed. It is unknown if, during the bioresorption process, the neointimal response of the everolimus BVS (Absorb, Abbott Vascular, Santa Clara, California) differs from that of the metallic everolimus DES (Xience, Abbott Vascular).

A total of 19 lesions were treated with a single everolimus DES, and 31 lesions were treated with everolimus BVS and imaged with optical coherence tomography at 1 year. Neointimal response was assessed as percentage of uncovered struts, neointimal thickness, in-stent/scaffold area obstruction, and pattern of neointima.

At 1 year, no significant differences in the angiographic lumen loss were seen for the everolimus DES and everolimus BVS (0.18 ± 0.20 mm vs. 0.29 ± 0.36 mm; p = 0.42). optical coherence tomography analysis of 951 cross sections and 8,385 struts demonstrated similar rates of uncovered struts (5.3% everolimus DES vs. 4.5% everolimus BVS; p = 0.11), mean neointimal thickness (120.6 ± 46.0 μm vs. 136.1 ± 71.4 μm; p = 0.82) and in-stent/scaffold area obstruction (12.5 ± 7.1% vs. 13.6 ± 9.7%; p = 0.91), respectively. There was a trend of higher heterogenic tissue pattern of neointima (21.1% vs. 6.5%; p = 0.12) and less intraluminal masses (0% vs. 12.9%; p = 0.10) with everolimus DES than with everolimus BVS.

The everolimus BVS (Absorb) demonstrated a similar neointimal response as the everolimus DES (Xience). However, the presence of intraluminal masses at 12 months in a small proportion of patients warranted watchful follow-up of these cases.

This study sought to investigate quantitative and homogeneity differential echogenicity changes of the ABSORB scaffold (1.1) during the first year after implantation.

The imaging of the ABSORB bioresorbable vascular scaffold degradation by intravascular ultrasound (IVUS) has previously demonstrated diminishing gray-level intensity of the struts over time that can be evaluated by IVUS-based differential echogenicity. The first generation of ABSORB (1.0) showed a 50% reduction in hyperechogenicity at 6 months and restoration of the pre-ABSORB implantation values at 2 years. The second generation of ABSORB (1.1), investigated in the ABSORB B trial, was modified to prolong the duration of luminal scaffolding.

A total of 63 patients were examined by IVUS immediately post-implantation and at 6-month (Cohort B1, n = 28) or 12-month (Cohort B2, n = 35) follow-up. IVUS-based tissue composition analysis software was used to quantify changes in hyperechogenicity over time in the scaffolded regions. Relative changes in hyperechogenicity were calculated as: 100 x (% hyperechogenicity at follow-up – % hyperechogenicity at baseline)/% hyperechogenicity at baseline.

At 6- and 12-month follow-up, there was a 15% (from 22.58 ± 9.77% to 17.42 ± 6.69%, p = 0.001) and 20% (from 23.51 ± 8.57% to 18.25 ± 7.19%, p < 0.001) reduction in hyperechogenicity, respectively, compared with post-implantation values. No difference in hyperechogenicity changes were observed between the proximal, medial, or distal part of the scaffolded segment.

Quantitative differential echogenicity changes of the ABSORB scaffold (1.1) during the first 12 months after implantation are lower compared with those previously observed with its first generation (1.0), confirming the value of the manufacturing changes and suggesting a slower degradation rate of the scaffold.

Even though acute strokes after TAVI have been described, it is uncertain if stroke rates continue to remain high in the early months after TAVI. Furthermore, the optimal dose and duration of thromboprophylaxis is unclear.

Patients who underwent TAVI were evaluated at baseline, at discharge, at 1 and 6 months, and yearly. Risk factors for CeV events, procedural details, and antithrombotic therapy were recorded. Outcomes assessed were CeV events and death. The timing of such events, predictors, and impact on survival were analyzed.

A total of 253 patients were assessed. Median age was 85 years. The median Society of Thoracic Surgeons score was 8.1% (interquartile range [IQR]: 5.5% to 12.0%). Risk factors included smoking (47%), hypertension (70%), dyslipidemia (66%), and diabetes mellitus (25%). Twenty-three percent had known cerebrovascular disease and 39% had atrial fibrillation. Median follow-up was 455 days (IQR: 160 to 912 days) at which time 23 patients experienced a CeV event. The incidence was highest in the first 24 h but remained high for 2 months. In-hospital mortality rate after a CeV event was 21%. A prior history of CeV disease was an independent predictor of an event (hazard ratio: 4.23, 95% CI: 1.60 to 11.11, p = 0.004).

The incidence of CeV events is highest within 24 h of TAVI, but this risk may remain elevated for up to 2 months. A prior history of cerebrovascular disease is an independent predictor. This may have implications for patient selection and antithrombotic strategies.

The XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System Condition-of-Approval Post-Market study) sought to: 1) evaluate the safety of everolimus-eluting coronary stent systems (EECSS) in a contemporary cohort of real-world subjects; and 2) prospectively test the quality of event reporting with analysis of matched patients from the randomized SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions) trial.

Randomized trials have demonstrated the safety and efficacy of EECSS in selected "standard-risk" patients.

The XIENCE V USA trial was a prospective, multicenter, single-arm study in unselected patients. The primary endpoint was Academic Research Consortium (ARC)-defined definite and probable stent thrombosis (ST); the co-primary endpoint was the composite of cardiac death and myocardial infarction at 1 year. Secondary analyses included: 1) stratification by standard-risk and extended-risk cohorts; and 2) late ST after dual antiplatelet therapy interruption.

Of 5,054 participants (1,875 standard-risk; 3,179 extended-risk), 4,958 (98.1%) reached 1-year follow-up. The rate of ARC-defined definite and probable ST was 0.84% (95% confidence interval [CI]: 0.60% to 1.14%) in the overall population and 0.33% (95% CI: 0.12% to 10.72%) and 1.14% (95% CI: 0.80% to 11.58%) in the standard-risk and extended-risk cohorts, respectively. No late ST was observed after dual antiplatelet therapy interruption in either cohort after 6 months. The composite rate of cardiac death and ARC-defined myocardial infarction was 6.5% (95% CI: 5.79% to 17.17%) in the overall population, 3.8% (95% CI: 2.98% to 14.78%) in the standard-risk cohort, and 8.0% (95% CI: 7.09% to 19.02%) in the extended-risk cohort.

This study comprehensively reports ST rates for EECSS in a contemporary real-world population. The absence of ST after dual antiplatelet therapy interruption beyond 6 months in standard-risk and high-risk patients is notable. Consistent safety outcomes between matched standard-risk cohorts from the XIENCE V USA study and the SPIRIT IV randomized trial suggest that this study affords a reliable benchmark for understanding the safety of EECSS in the context of real-world clinical practice. (XIENCE V Everolimus Eluting Coronary Stent System [EECSS] USA Post-Approval Study; NCT00676520)

The hoops of coronary stents provide radial support, and connectors hold hoops together. Strut material, shape, and thickness, along with connector number and configuration, provide the balance between stent flexibility and longitudinal integrity. Longitudinal distortion manifests as length change, strut overlap, strut separation, malapposition, and luminal obstruction. These may predispose to restenosis and stent thrombosis, obstruct passage of devices, be misinterpreted as strut fracture, and require additional stenting.

The force required to compress and to elongate 7 contemporary stents was measured with an Instron universal testing machine (Norwood, Massachusetts). Stents deployed in a silicone phantom damaged by a balloon or guide catheter were imaged by microcomputed tomography to understand better the appearances and effects of longitudinal distortion.

Stents with 2 connectors (Boston Scientific [Natick, Massachusetts] Omega and Medtronic [Santa Rosa, California] Driver) required significantly less force to be compressed up to 5 mm and elongated by 1 mm than designs with more connectors. The 6-connector Cypher Select required significantly more force to be elongated 5 mm than other designs.

Stents with 2 connectors between hoops have less longitudinal strength when exposed to compressing or elongating forces than those with more connectors. This independent, standardized study may assist stent selection in clinical situations where longitudinal integrity is important, and may aid future design improvements.

Stent longitudinal strength, the resistance to shortening or elongation, appears related to the number of connectors between hoops. Using a standardized testing protocol, designs with 2 connectors were more likely to shorten or elongate than those with more connectors. Distortion may be recognized clinically as bunching or separation of struts, and may be confused with strut fracture. Without post-dilation or further stent deployment, the patient may be at increased risk for adverse clinical events. A stent design change ensuring 3 connectors, especially at the proximal end of a stent, should increase longitudinal integrity, but perhaps at the expense of stent flexibility.

Implanting large devices, such as mitral or aortic valve prostheses, into the heart requires surgical exposure and repair. Reliable percutaneous direct transthoracic LV access and closure would allow new nonsurgical therapeutic procedures.

Percutaneous direct LV access was performed in 19 swine using real-time magnetic resonance imaging (MRI) and an "active" MRI needle antenna to deliver an 18-F introducer sheath. The LV access ports were closed percutaneously using a commercial ventricular septal defect occluder and an "active" MRI delivery cable for enhanced visibility. We used "permissive pericardial tamponade" (temporary fluid instillation to separate the 2 pericardial layers) to avoid pericardial entrapment by the epicardial disk. Techniques were developed in 8 animals, and 11 more were followed up to 3 months by MRI and histopathology.

Imaging guidance allowed 18-F sheath access and closure with appropriate positioning of the occluder inside the transmyocardial tunnel. Of the survival cohort, immediate hemostasis was achieved in 8 of 11 patients. Failure modes included pericardial entrapment by the epicardial occluder disk (n = 2) and a true-apex entry site that prevented hemostatic apposition of the endocardial disk (n = 1). Reactive pericardial effusion (192 ± 118 ml) accumulated 5 ± 1 days after the procedure, requiring 1-time drainage. At 3 months, LV function was preserved, and the device was endothelialized.

Direct percutaneous LV access and closure is feasible using real-time MRI. A commercial occluder achieved hemostasis without evident deleterious effects on the LV. Having established the concept, further clinical development of this approach appears realistic.

Surgical, percutaneous, and hybrid management of VSD each have limitations and known morbidity.

Percutaneous muscular VSDs were created in 10 naive Yorkshire swine using a transjugular laser catheter. Under real-time MRI guidance, a direct transthoracic vascular access sheath was introduced through the chest into the heart along a trajectory suitable for VSD access and closure. Through this transthoracic sheath, muscular VSDs were occluded using a commercial nitinol device. Finally, the right ventricular free wall was closed using a commercial collagen plug intended for arterial closure.

Anterior, posterior, and mid-muscular VSDs (6.8 ± 1.8 mm) were created. VSDs were closed successfully in all animals. The transthoracic access sheath was displaced in 2, both fatal. Thereafter, we tested an intracameral retention sheath to prevent this complication. Right ventricular access ports were closed successfully in all, and after as many as 30 days, healed successfully.

Real-time MRI guidance allowed closed-chest transthoracic perventricular muscular VSD closure in a clinically meaningful animal model. Once applied to patients, this approach may avoid traditional surgical, percutaneous, or open-chest transcatheter ("hybrid") risks.

Hospital readmissions occur frequently and incur substantial costs. PCI are among the most common and costly procedures, and little is known about the nature and extent of readmissions for PCI.

We retrospectively analyzed 30-day readmissions after PCI using the nation's largest statewide PCI registry to identify 40,093 New York State patients who underwent PCI between January 1, 2007, and November 30, 2007. Demographic variables, pre-procedural risk factors, complications of PCI, and length of stay were considered as potential predictors of readmission, and reasons for readmission were identified from New York's administrative database using principal diagnoses.

A total of 15.6% of all PCI patients were readmitted within 30 days, and 20.6% of these readmissions were staged. Among unstaged readmissions, the most common reasons for readmission were chronic ischemic heart disease (22.5%), chest pain (10.8%), and heart failure (8.2%). A total of 2,015 patients (32.2% of readmissions) underwent a repeat PCI. Thirteen demographic and diagnostic risk factors, as well as longer lengths of stay, were all associated with higher readmission rates.

Future efforts to reduce readmissions should be directed toward the recognition of patients most at risk, and the reasons they are readmitted. Staging also should be examined from a cost-effectiveness standpoint as a function of patients' unique risk factors.

For identifying significant LM disease, optimal cutoff of minimal lumen area (MLA) and its accuracy remain debatable.

We identified 55 patients (31 stable and 24 unstable angina) with an isolated LM lesion of 30% to 80% angiographic diameter stenosis who underwent IVUS and invasive physiological assessment before intervention.

The FFR at maximum hyperemia significantly correlated with IVUS-measured MLA within the LM (r = 0.623, p < 0.001), plaque burden (r = –0.548, p < 0.001), angiographic diameter stenosis (r = –0.449, p = 0.002), and angiographic length of the lesion (r = –0.292, p = 0.046). The FFR was significantly lower in 18 lesions with plaque rupture than 37 lesions without plaque rupture (0.76 ± 0.09 vs. 0.82 ± 0.09, p = 0.018). The independent determinants of FFR as a continuous variable were MLA (beta = 0.598, p < 0.001) and plaque rupture (beta = –0.255, p = 0.038). Furthermore, the MLA within the LM was the only independent determinant for FFR <0.80 (adjusted odds ratio: 0.312, p < 0.001) and for FFR <0.75 (adjusted odds ratio: 0.196, p = 0.001). The IVUS MLA value within the LM that best predicted FFR <0.80 was <4.8 mm² (89% sensitivity, 83% specificity). In addition, the cutoff value of plaque burden to predict FFR <0.80 was ≥72% (73% sensitivity, 79% specificity). The best cutoff values of the MLA and plaque burden for predicting FFR <0.75 were <4.1 mm² (95% sensitivity, 83% specificity) and ≥76% (79% sensitivity, 80% specificity), respectively.

In isolated LM disease, an IVUS-derived MLA <4.8 mm² is a useful criterion for predicting FFR <0.80.

When revascularization is based mainly on angiographic guidance, a number of hemodynamically nonsignificant stenoses will be revascularized.

In 730 patients with a 30% to 70% isolated stenosis in the proximal LAD and no significant valvular disease, FFR measurements were obtained to guide treatment strategy. When FFR was ≥0.80, the patients (n = 564) were treated medically (medical group); when FFR was <0.80, the patients (n = 166) underwent a revascularization procedure (revascularization group; 13% coronary artery bypass graft surgery and 87% percutaneous coronary intervention). A 100% long-term clinical follow-up (median follow-up: 40 months) was obtained. The 5-year survival of the medical group was compared with that of a reference population. For each patient, 4 controls were selected from an age- and sex-matched control population.

The 5-year survival estimate was 92.9% in the medical group versus 89.6% in the controls (p = 0.74). The mean diameter stenosis was significantly smaller in the medical than in the revascularization group (39 ± 14% vs. 54 ± 13%, p < 0.0001), but there was a large overlap between both groups. The 5-year event-free survival estimates (death, myocardial infarction, and target vessel revascularization) were 89.7% and 68.5%, respectively (p < 0.0001).

Medical treatment of patients with a hemodynamically nonsignificant stenosis (FFR ≥0.80) in the proximal LAD is associated with an excellent long-term clinical outcome with survival at 5 years similar to an age- and sex-matched control population.

The use of FFR to guide PCI has been well established for patients with SA. Its use in patients with UA or NSTEMI has not been investigated prospectively.

In the FAME (Fractional flow reserve versus Angiography for Multivessel Evaluation) study 1,005 patients with multivessel disease amenable to PCI were included and randomized to either angiography-guided PCI of all lesions ≥50% or FFR-guided PCI of lesions with an FFR ≤0.80. Patients admitted for UA or NSTEMI with positive troponin but total creatine kinase <1,000 U/l were eligible for inclusion. We determined 2-year major adverse cardiac event rates of these patients and compared it with stable patients.

Of 1,005 patients, 328 had UA or NSTEMI. There was no evidence for heterogeneity among the subgroups for any of the outcome variables (all p values >0.05). Using FFR to guide PCI resulted in similar risk reductions of major adverse cardiac events and its components in patients with UA or NSTEMI, compared with patients with SA (absolute risk reduction of 5.1% vs. 3.7%, respectively, p = 0.92). In patients with UA or NSTEMI, the number of stents was reduced without increase in hospital stay or procedure time and with less contrast use, in similarity to stable patients.

The benefit of using FFR to guide PCI in multivessel disease does not differ between patients with UA or NSTEMI, compared with patients with SA.

The risk of perioperative stroke in patients undergoing CABG who report a prior history of transient ischemic attack or stroke has been associated with a 4-fold increased risk as compared to the risk for neurologically asymptomatic patients. It seems appropriate to offer prophylactic carotid endarterectomy to neurologically symptomatic patients who have significant carotid artery disease and are scheduled for CABG. The CAS-CABG outcome for symptomatic patients remains underreported, notwithstanding randomized data supporting CAS for high-risk patients.

In a prospective, single-center study, the periprocedural and long-term outcomes of 57 consecutive patients who underwent CAS before cardiac surgery were analyzed.

The procedural success rate of CAS was 98%. The combined death, stroke, and myocardial infarction rate was 12.3%. The death and major stroke rate from time of CAS to 30 days after cardiac surgery was 3.5%. The myocardial infarction rate from time of CAS to 30 days after cardiac surgery was 1.5%.

This is the first single-center study reporting the combined outcome of CAS-CABG in symptomatic patients. The periprocedural complication rate and long-term results of the CAS-CABG strategy in this high-risk population support the reliability of this approach. In such a high-risk population, this strategy might offer a valuable alternative to the combined surgical approach; however, a large randomized trial is clearly warranted.

The optimal modality of carotid revascularization preceding cardiac surgery is unknown.

Retrospective evaluation of the CARE (Carotid Artery Revascularization and Endarterectomy) registry from January 2005 to April 2010 was performed on patients undergoing CEA or CAS preceding urgent cardiac surgery within 30 days. Baseline characteristics were compared, and multivariate adjustment was performed.

Of 451 patients who met study criteria, 255 underwent CAS and 196 underwent CEA. Both procedures increased over time to a similar degree (p = 0.18). Patients undergoing CAS had more frequent history of peripheral artery disease (38.2% vs. 26.5%, p < 0.01), neck surgery (5.5% vs. 1.0%, p = 0.01), neck radiation (4.3% vs. 1.0%, p = 0.04), left-main coronary disease (34.8% vs. 23.5%, p < 0.01), neurological events (45.8% vs. 31.3%, p < 0.01), carotid intervention (20.8% vs. 7.6%, p < 0.01), and higher baseline creatinine (1.3 vs. 1.1 mg/dl, p = 0.02). The target carotid arteries of CAS patients were more likely to be symptomatic in the 6 months before revascularization and have restenosis from prior CEA. Patients undergoing CAS had a lower American Society of Anesthesiology grade. Midwest hospitals were less likely to perform CAS than CEA, whereas in the other regions CAS was more common (p < 0.01). Non-Caucasian race, a history of heart failure, previous carotid procedures, prior stroke, left main coronary artery stenosis, lower American Society of Anesthesiology grade, and teaching hospital were independent predictors of patients who would receive CAS.

Carotid artery stenting and CEA have increased among patients undergoing urgent cardiac surgery. Patients who underwent CAS had more vascular disease but lower acute pre-surgical risk. Significant regional variation in procedure selection exists.

Lesion length and RVD are well-known predictors of adverse events after percutaneous coronary intervention.

Patient-level data were pooled from the randomized SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) II, III, IV and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) trials. Quantitative angiographic core laboratory data were available for 6,183 patients randomized to EES (n = 3,944) or PES (n = 2,239). Long lesions and small vessels were defined as LL >median (13.4 mm) and RVD ≤median (2.65 mm), respectively. Major adverse cardiac events (MACE) (consisting of cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization) were assessed at 2 years, according to stent type in 3 groups: short lesions in large vessels (group A, n = 1,297); long lesions or small vessels but not both (group B, n = 2,981); and long lesions in small vessels (group C, n = 1,905).

The pooled 2-year MACE rates were 5.6%, 8.2%, and 10.4% in Groups A, B, and C, respectively (p < 0.0001). There was no significant interaction between lesion group and stent type (p = 0.64), indicating lower MACE with EES compared with PES regardless of LL and RVD. However, the absolute difference was largest in Groups B and C. In Group A, 2-year MACE rates were not significantly different between EES and PES (4.8% vs. 7.0%, respectively, p = 0.11). In contrast, EES was associated with lower 2-year rates of MACE in Group B (6.6% vs. 11.2%, p < 0.01) and in Group C (9.1% vs. 12.7%, p = 0.008) as well as lower rates of myocardial infarction, target lesion revascularization, and stent thrombosis. Multivariable analysis confirmed EES versus PES as an independent predictor of freedom from MACE in Groups B and C.

Patients with short lesions in large vessels have low rates of MACE at 2 years after treatment with either EES or PES. In higher-risk patients with long lesions and/or small vessels, EES results in significant improvements in both clinical safety and efficacy outcomes. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00180479; SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00307047; A Randomized Controlled Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial; NCT01016041)

Redo cardiac surgery for degenerated bioprosthetic heart valves is associated with increased risks, particular in elderly patients with comorbidities. For these patients, TAVI may be an attractive, less invasive treatment option.

Data from 47 patients age 64 to 97 years (logistic euroSCORE: 35.0 ± 18.5%) undergoing transfemoral (n = 25) or transapical (n = 22) viv-TAVI for failed bioprosthetic aortic valves 113 ± 65 months after initial surgery at 9 clinical sites in Germany and Switzerland were analyzed.

Valve-in-valve TAVI was technically successful in all patients, with 2 patients requiring bailout implantation of a second TAVI prosthesis for severe regurgitation during the procedure. There was 1 procedural death as the result of low-output failure. Valvular function after viv-TAVI was excellent with respect to valve competence, but increased transvalvular gradients ≥20 mm Hg were noted in 44% of patients. Vascular access complications occurred in 6 (13%) patients, and 5 (11%) patients required new pacemaker implantation after viv-TAVI. Renal failure requiring dialysis occurred in 4 (9%) patients. Mortality at 30 days was 17% (1 procedural and 7 post-procedural deaths), with 3 of 8 fatalities the result of non–valve-related septic complications.

Valve-in-valve TAVI can be performed with high technical success rates, acceptable post-procedural valvular function, and excellent functional improvement. However, in these predominantly elderly high-risk patients with multiple comorbidities, viv-TAVI was associated with 17% mortality, often because of septic complications arising in the post-operative phase.

Transcatheter aortic valve implantation with the CRS is an effective option in high-risk patients with severe aortic stenosis. It may be an option for patients with a failed aortic bioprosthesis, especially when the risk of a surgical redo is deemed prohibitive.

CRS "valve-in-valve" implantation was performed in 25 high-risk patients with a failed bioprosthesis. Their mean age was 82.4 ± 3.2 years. New York Heart Association functional classes III and IV were present in 21 and 4 patients, respectively. The logistic EuroSCORE was 31.5 ± 14.8%, whereas the Society of Thoracic Surgeons score was 8.2 ± 4.2. Patients/prostheses were divided in type A (mainly stenotic, n = 9) and type B (mainly regurgitant, n = 16).

The implantation success rate was 100%. In group A, the peak aortic gradient significantly decreased from 77.6 ± 21.6 mm Hg to 34.6 ± 19.4 mm Hg (p = 0.001). In all but 2 patients in group B, no significant regurgitation was observed post-implantation. No patients died during the procedure. At 30 days, there were 3 deaths (12%), 2 myocardial infarctions (8%), and 3 atrioventricular blocks requiring pacemaker implantation (12%). At a mean follow-up of 6 months, there were another death (survival rate of 84%) and a pacemaker implantation (cumulative incidence of 16%). New York Heart Association functional class improved in all patients to I and II.

CRS implantation was feasible and effective regardless of the prevalent mode of failure. This finding may significantly affect the treatment of patients with a failed bioprosthesis deemed at a prohibitive risk for surgical redo.

The reproducibility and applicability of MDCT annular measurements to guide transcatheter aortic valve implantation remain unclear.

Annular measurements were performed in 50 patients planed for transcatheter aortic valve implantation in multiple planes: basal ring (short- and long-axis, mean diameter, area-derived diameter), coronal, sagittal, and 3-chamber projections. A theoretical model was developed taking into account the differences between the most reproducible MDCT measurements and transesophageal echocardiography to guide valve size choice.

The most reproducible measurements were the area-derived diameter and basal ring average diameter (inter-reader intraclass correlation coefficient: 0.87 [95% confidence interval: 0.81 to 0.92] and 0.80 [95% confidence interval: 0.70 to 0.87]; respectively; intrareader >0.90 for all readers). These were generally larger than transesophageal echocardiography diameters (mean difference of 1.5 ± 1.6 mm and 1.1 ± 1.7 mm, respectively). When a strategy of valve-sizing is undertaken using these CT measurements using an echocardiographic sizing scale, a different THV size would be selected in 44% and 40% of cases, respectively. When adjusting the sizing cutoffs to account for the differences in observed diameters, this was reduced to 10% to 12% (p < 0.01 for both, respectively).

The most reproducible MDCT measurements of the annulus are the area-derived diameter and basal ring average diameter, with derived values generally larger than those obtained with echocardiography. If MDCT is used for valve sizing, a strategy incorporating these differences may be important. MDCT using these easily derived measurements may be ideally suited to sizing transcatheter aortic valves as they account for the eccentricity of the aortic annulus, are reproducible, and are noninvasive.

The amount of NIH following DES implantation correlates with the potency of the antiproliferative drug, its kinetic release, as well as some individual characteristics, as the presence of diabetes mellitus (DM). Recently, some publications have suggested a continuous growth of NIH following DES, which in some cases, might result in late "catch-up."

Twenty-five patients with single, de novo lesions were treated with sirolimus-eluting stents (SES) (n = 12) and biolimus-eluting stents (BES) (n = 13) and underwent intravascular ultrasound evaluation immediately after the procedure and at 9-month and 5-year follow-ups. The primary endpoint was the comparison of the percentage of NIH obstruction between mid- and long-term follow-up.

Mean age was 59 years and 28% of patients had DM. Overall, the percentage of NIH obstruction significantly increased from 9 months to 5 years (1.3% at first follow-up vs. 4.8% at second follow-up, p = 0.002). There was no significant difference in the variation of vessel volume ( = –0.70 mm³/mm BES vs. = 0.18 mm³/mm SES, p = 0.56), lumen volume ( = 0.40 mm³/mm BES vs. = –0.05 mm³/mm SES, p = 0.71), and percentage of NIH obstruction ( = 3.0% BES vs. = 3.8% SES, p = 0.55) among DES. However, diabetic patients had a marked NIH increase along the years (NIH volume at second follow-up: 10.15 mm³ DM vs. 5.11 mm³ non-DM, p = 0.028).

The present serial intravascular ultrasound assessment supports the occurrence of continuous NIH growth following different generations of DES. These findings seem to be particularly more pronounced among patients with DM.

FFR is a validated method for the assessment of the severity of coronary artery stenosis. It is based on the change in the pressure gradient across the stenosis after the achievement of maximal hyperemia of the coronary microcirculation that may be obtained by either intracoronary bolus or intravenous infusion of adenosine. No study has explored so far the effects of very high doses of intracoronary adenosine on FFR.

FFR was assessed in 46 patients with 50 intermediate lesions during cardiac catheterization by pressure-recording guidewire (PrimeWire, Volcano, San Diego, California). FFR was calculated as the ratio of the distal coronary pressure to the aortic pressure at hyperemia. Increasing doses of adenosine were administrated (60, 120, 180, 360, and 720 μg) as intracoronary boluses. Exclusion criteria were: 1) allergy to adenosine; 2) baseline bradycardia (heart rate <50 beats/min); 3) hypotension (blood pressure <90 mm Hg); and 4) refusal to provide signed informed consent.

High doses of intracoronary adenosine were well tolerated, with no major side effects. Increasing doses up to 720 μg progressively decreased FFR values and increased the percentage of patients showing an FFR <0.75. Among angiographic parameters, both percent stenosis and lesion length were independently associated with lower FFR values.

This study shows that high doses of intracoronary adenosine (up to 720 μg) increased the sensitivity of FFR in the detection of hemodynamically relevant coronary stenoses. Furthermore, lesion length and stenosis severity were independent angiographic determinants of FFR.

Fractional flow reserve is an established invasive method for assessing the physiological significance of CAS. Regadenoson, a selective A_2A receptor agonist, is an approved hyperemic agent for pharmacological stress imaging, but its role for measuring FFR is unknown.

This prospective, single-center study enrolled 25 consecutive patients with intermediate CAS discovered during elective angiography (25 lesions). In each patient, FFR of the CAS was measured first by IV adenosine (140 μg/kg/min), followed by IV regadenoson (400 μg bolus). The intrapatient FFR correlation between adenosine and regadenoson was evaluated.

The mean age was 63 ± 11 years, and mean left ventricular ejection fraction was 58 ± 11%. Most patients were male (52%) and had hypertension (84%) and dyslipidemia (84%), with 24% having diabetes mellitus and 20% chronic obstructive pulmonary disease. The CAS was visually estimated during angiography (mean 58 ± 9%) and most often found in the left anterior descending coronary artery (48%). A strong, linear correlation of FFR was noted with adenosine and regadenoson (r = 0.985, p < 0.001). A hemodynamically significant lesion (FFR ≤0.80) was present in 52% with no reclassification of significance between adenosine and regadenoson. No serious events occurred with administration of either drug.

Our results suggest that a single IV bolus of regadenoson is as effective as an intravenous infusion of adenosine for measuring FFR and, given its ease of use, should be considered for FFR measurement in the catheterization laboratory.

Outcomes remain relatively unfavorable for stent-based coronary intervention of lesions with long diseased segments.

This randomized, multicenter, prospective trial compared the use of long EES with SES in 450 patients with long (≥25 mm) native coronary lesions. The primary endpoint of the trial was in-segment late luminal loss at 9-month angiographic follow-up.

The EES and SES groups had similar baseline characteristics. Lesion length was 34.0 ± 15.4 mm in the EES group and 34.3 ± 13.5 mm in the SES group (p = 0.85). Nine-month angiographic follow-up was performed in 80% of the EES group and 81% of the SES group (p = 0.69). In-segment late loss as the primary study endpoint was significantly larger in the EES group than in the SES group (0.17 ± 0.41 mm vs. 0.09 ± 0.30 mm, p for noninferiority = 0.96, p for superiority = 0.04). The in-segment binary restenosis rate was also higher in the EES group than in the SES group (7.3% vs. 2.7%, p = 0.046). However, in-stent late loss (0.22 ± 0.43 mm vs. 0.18 ± 0.28 mm, p = 0.29) and in-stent binary restenosis rate (3.9% vs. 2.7%, p = 0.53) were similar among the 2 groups. The incidence of any clinical outcomes (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes) was not statistically different between the 2 groups.

For patients with long native coronary artery disease, EES implantation was associated with greater angiographic in-segment late loss and higher rates of in-segment restenosis compared with SES implantation. However, clinical outcomes were both excellent and not statistically different. (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III [LONG-DES-III]; NCT01078038)

Although randomized trials have shown superiority of EES to PES, the safety and efficacy of EES in ACS is unknown.

We performed a patient-level pooled analysis from the prospective, randomized SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) II, III, IV, and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) trials in which 2,381 patients with ACS and 4,404 patients with stable CAD were randomized to EES or to PES. Kaplan-Meier estimates of death, myocardial infarction (MI), ischemia-driven target lesion revascularization, and stent thrombosis were assessed at 2 years and stratified by clinical presentation (ACS vs. stable CAD).

At 2 years, patients with ACS compared with stable CAD had higher rates of death (3.2% vs. 2.4%, hazard ratio [HR]: 1.37 [95% confidence interval (CI): 1.02 to 1.85], p = 0.04) and MI (4.9% vs. 3.4%, HR: 1.45 [95% CI: 1.14 to 1.85], p = 0.02). In patients with ACS, EES versus PES reduced the rate of death or MI (6.6% vs. 9.3%, HR: 0.70 [95% CI: 0.52 to 0.94], p = 0.02), stent thrombosis (0.7% vs. 2.9%, HR: 0.25 [95% CI: 0.12 to 0.52], p = 0.0002), and ischemia-driven target lesion revascularization (4.7% vs. 6.2%, HR: 0.69 [95% CI: 0.48 to 0.99], p = 0.04). In patients with stable CAD, EES reduced the rate of death or MI (4.5% vs. 7.1%, HR: 0.62 [95% CI: 0.48 to 0.80], p = 0.0002), stent thrombosis (0.7% vs. 1.8%, HR: 0.34 [95% CI: 0.19 to 0.62], p = 0.0002), and ischemia-driven target lesion revascularization (3.9% vs. 6.9%, HR: 0.55 [95% CI: 0.42 to 0.73], p < 0.0001).

Treatment with EES versus PES provides enhanced safety and efficacy regardless of the acuity of the clinical syndrome being treated and appears to mitigate the increased risk of stent thrombosis associated with ACS. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions [SPIRIT II]; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With de Novo Native Coronary Artery Lesions [SPIRIT III]; NCT00180479; SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions [SPIRIT IV]; NCT00307047; A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice: the COMPARE Trial [COMPARE]; NCT01016041)

Despite treatment recommendations for at least 12 months of DAPT following drug-eluting stent revascularization, device-specific outcomes relative to DAPT duration are absent.

Among 2,032 patients undergoing percutaneous coronary revascularization with ZES in 5 trials, late safety events were compared relative to DAPT duration for patients with ≥6 months DAPT adherence and survival free of major ischemic and bleeding events.

A total of 1,414 event-free patients on DAPT at 6 months were identified. Patient group comparisons relative to DAPT included: 6 months versus ≥12 months, and 6 months versus ≥24 months. Through 3 years, risk-adjusted ischemic event rates did not significantly differ between groups: 6 versus ≥12 months: death (2.7% vs. 2.2%), myocardial infarction (MI, 0.3% vs. 1.1%), and definite/probable stent thrombosis (ST, 0.3% vs. 0%); 6 versus ≥24 months: death (1.6% vs. 1.6%), MI (0.4% vs. 1.2%), and definite/probable ST (0.1% vs. 0.2%). Composite events also did not statistically vary between DAPT durations. In multivariable analysis, 6-month versus longer DAPT duration was not associated with increased likelihood of thrombotic events at 3-year follow-up. Major bleeding was negligible across groups.

Among patients treated with ZES, late-term events of death, MI, stroke, and ST do not significantly differ between patients taking 6 months DAPT compared with continuation beyond 1 year. These findings merit further study to identify the appropriate duration of DAPT according to specific drug-eluting stents.

It is accepted that exposure to radiation includes a predicted increase in cancer risk. In the cardiac interventional laboratories, radiation shields are widely available; however, proper use of the shields to optimize protection during cardiac interventional procedures is not well understood.

The protection from scatter radiation offered by a variety of shields used alone and in combination was measured. Protection was assessed from air-kerma measurements of scatter radiation from a phantom performed without and with the shields. Protection was assessed for 3 patient- access locations (right jugular vein, right femoral artery, and left anterior chest) and for elevations ranging from 25 to 175 cm from the floor. The influence of precise placement of the ceiling-mounted upper body shield was specifically assessed.

The utility and protection of shielding varied for the 3 access points and with elevation. For femoral artery access locations, the shields can provide at least 80% protection from scatter at all elevations; however, protection depends substantially on upper body shield position. A disposable radiation-absorbing pad can provide 35% to 70% upper body protection for procedures during which the upper body shield cannot be used effectively.

Radiation shields can provide substantial protection from radiation during cardiac interventional procedures. Shields must be thoughtfully and actively managed to provide optimum protection. Best practice guidelines for shield use are provided.

EMB is an integral part of the diagnostic evaluation of ARVC. Due to safety concerns, EMB are often obtained from the RV septum, which is usually spared from characteristic alterations. At our institution, EMB in ARVC patients were sampled target-directed from predilection areas and areas with abnormal contraction.

Under fluoroscopic guidance, 3,777 EMB samples from 6 different RV sites were obtained in 482 patients who were evaluated for unclear cardiomyopathy (n = 280; 58%), assumed myocarditis (n = 59; 12%), or unexplained ventricular tachyarrhythmias (n = 143; 30%). Complication rates were compared with those from exclusively septal EMB procedures (n = 2,321) in 271 patients after heart transplantation (HTx).

Overall, no procedure-related deaths or sustained ventricular tachyarrhythmias occurred. A pericardial effusion was reported in 6 of 161 patients with the final diagnosis of ARVC (3.7%) needing no further intervention in all but 1 patient (0.6%) who required pericardiocentesis. Among the non-ARVC patients (n = 321), the incidence of a minor pericardial effusion (3.9%) and cardiac tamponade (2.2%) was comparable to that in ARVC (p = NS) but was higher when compared with HTx (p < 0.001). A transient complete atrioventricular block occurred in 1 of 321 non-ARVC (0.3%) and 2 of 271 HTx patients (0.1%).

Multisite target-directed EMB sampling in ARVC is a safe procedure when performed by experienced interventionalists. The procedure-related complication rates were low and comparable to those in other cardiomyopathies.