Reduced Leaflet Motion after Transcatheter Aortic-Valve Replacement.

BACKGROUND: Subclinical leaflet thickening and reduced leaflet motion of bioprosthetic aortic valves have been documented by four-dimensional computed tomography (CT). Whether anticoagulation can reduce these phenomena after transcatheter aortic-valve replacement (TAVR) is not known. METHODS: In a substudy of a large randomized trial, we randomly assigned patients who had undergone successful TAVR and who did not have an indication for long-term anticoagulation to a rivaroxaban-based antithrombotic strategy (rivaroxaban [10 mg] plus aspirin [75 to 100 mg] once daily) or an antiplatelet-based strategy (clopidogrel [75 mg] plus aspirin [75 to 100 mg] once daily). Patients underwent evaluation by four-dimensional CT at a mean (±SD) of 90±15 days after randomization. The primary end point was the percentage of patients with at least one prosthetic valve leaflet with grade 3 or higher motion reduction (i.e., involving >50% of the leaflet). Leaflet thickening was also assessed. RESULTS: A total of 231 patients were enrolled. At least one prosthetic valve leaflet with grade 3 or higher motion reduction was found in 2 of 97 patients (2.1%) who had scans that could be evaluated in the rivaroxaban group, as compared with 11 of 101 (10.9%) in the antiplatelet group (difference, -8.8 percentage points; 95% confidence interval [CI], -16.5 to -1.9; P = 0.01). Thickening of at least one leaflet was observed in 12 of 97 patients (12.4%) in the rivaroxaban group and in 33 of 102 (32.4%) in the antiplatelet group (difference, -20.0 percentage points; 95% CI, -30.9 to -8.5). In the main trial, the risk of death or thromboembolic events and the risk of life-threatening, disabling, or major bleeding were higher with rivaroxaban (hazard ratios of 1.35 and 1.50, respectively). CONCLUSIONS: In a substudy of a trial involving patients without an indication for long-term anticoagulation who had undergone successful TAVR, a rivaroxaban-based antithrombotic strategy was more effective than an antiplatelet-based strategy in preventing subclinical leaflet-motion abnormalities. However, in the main trial, the rivaroxaban-based strategy was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than the antiplatelet-based strategy. (Funded by Bayer; GALILEO-4D ClinicalTrials.gov number, NCT02833948.).

Deploying a novel custom mobile application for STEMI activation and transfer in a large healthcare system to improve cross-team workflow. STEMIcathAID implementation project.

BACKGROUND: ST-segment elevation myocardial infarction (STEMI) is a high-risk patient medical emergency. We developed a secure mobile application, STEMIcathAID, to optimize care for STEMI patients by providing a digital platform for communication between the STEMI care team members, EKG transmission, cardiac catherization laboratory (cath lab) activation and ambulance tracking. The aim of this report is to describe the implementation of the app into the current STEMI workflow in preparation for a pilot project employing the app for inter-hospital STEMI transfer. APPROACH: App deployment involved key leadership stakeholders from all multidisciplinary teams taking care of STEMI patients. The team developed a transition plan addressing all aspects of the health system improvement process including the workflow analysis and redesign, app installation, personnel training including user account access to the app, and development of a quality assurance program for progress evaluation. The pilot will go live in the Emergency Department (ED) of one of the hospitals within the Mount Sinai Hospital System (MSHS) during the daytime weekday hours at the beginning and extending to 24/7 schedule over 4-6 weeks. For the duration of the pilot, ED personnel will combine the STEMIcathAID app activation with previous established STEMI activation processes through the MSHS Clinical Command Center (CCC) to ensure efficient and reliable response to a STEMI alert. More than 250 people were provisioned app accounts including ED Physicians and frontline nurses, and trained on their user-specific roles and responsibilities and scheduled in the app. The team will be provided with a feedback form that is discipline specific to complete after every STEMI case in order to collect information on user experience with the STEMIcathAID app functionality. The form will also provide quantitative metrics for the key time sensitive steps in STEMI care. CONCLUSIONS: We developed a uniform approach for deployment of a mobile application for STEMI activation and transfer in a large urban healthcare system to optimize the clinical workflow in STEMI care. The results of the pilot will demonstrate whether the app has a significant impact on the quality of care for transfer of STEMI patients.

Outcomes and feasibility of redo-TAVR after Sapien 3 Ultra TAVR in extremely-undersized versus nominally-sized annuli.

OBJECTIVES: To compare outcomes in Sapien 3 Ultra (S3U) transcatheter aortic valve replacement (TAVR) with extreme annular undersizing (EAU) versus nominal annular sizing (NAS). BACKGROUND: The Edwards S3U valve has reduced paravalvular leak (PVL) in TAVR but outcomes remain unknown in extremely undersized anatomy. Implanting a smaller S3U valve may facilitate future redo-TAVR but risk compromising hemodynamics. METHODS: From December 2019 to July 2021, 366 patients with native aortic stenosis underwent S3U TAVR. Patients with EAU (annular areas >430 mm2 for 23 mm or >546 mm2 for 26 mm) were compared to NAS (338-430 mm2 for 23 mm or 430-546 mm2 for 26 mm). In-hospital and 30-day outcomes, and redo-TAVR feasibility were determined. RESULTS: There were 79 (21.6%) EAU patients, with more bicuspid (p = 0.0014) and ≥moderate annular/left ventricular outflow tract calcification (p < 0.001). The EAU group had less annular oversizing than NAS group (23 mm: -8.2 ± 2.6% vs. 4.0 ± 7.0%, p < 0.001; 26 mm: -8.9 ± 2.2% vs. 6.7 ± 6.9%, p < 0.001), more balloon overfilling (71.3% vs. 11.6%, p < 0.001), and postdilatation (15.0% vs. 5.8%, p = 0.016). No differences were found in in-hospital or 30-day mortality and stroke (p > 0.05). Mild PVL (13.4% EAU vs. 11.5% NAS, p = 0.56) and mean gradients (23 mm: 13.0 ± 4.5 vs. 14.1 ± 5.4 mmHg, p = 0.40; 26 mm: 11.4 ± 4.1 vs. 11.5 ± 3.9 mmHg, p = 1.0) were similar at 30 days. Had the EAU group undergone NAS with the larger Sapien 3/S3U, by computed tomography analysis simulating 80:20 or 90:10 target implant depth, 33.3%-60.9% (vs. 4.3%-23.2%) would not be feasible for redo-TAVR due to high risk of coronary obstruction. CONCLUSIONS: In this first report of EAU with S3U TAVR, similar excellent short-term outcomes can be achieved compared to NAS, and may preserve future redo-TAVR option.

Perioperative risk and antiplatelet management in patients undergoing non-cardiac surgery within 1 year of PCI.

Perioperative cardiovascular complications are important causes of morbidity and mortality associated with non-cardiac surgery, especially in patients with recent percutaneous coronary intervention (PCI). We aimed to illustrate the types and timing of different surgeries occurring after PCI, and to evaluate the risk of thrombotic and bleeding events according to the perioperative antiplatelet management. Patients undergoing urgent or elective non-cardiac surgery within 1 year of PCI at a tertiary-care center between 2011 and 2018 were included. The primary outcome was major adverse cardiac events (MACE; composite of death, myocardial infarction, or stent thrombosis) at 30 days. Perioperative bleeding was defined as ≥ 2 units of blood transfusion. A total of 1092 surgeries corresponding to 747 patients were classified by surgical risk (low: 50.9%, intermediate: 38.4%, high: 10.7%) and priority (elective: 88.5%, urgent/emergent: 11.5%). High-risk and urgent/emergent surgeries tended to occur earlier post-PCI compared to low-risk and elective ones, and were associated with an increased risk of both MACE and bleeding. Preoperative interruption of antiplatelet therapy (of any kind) occurred in 44.6% of all NCS and was more likely for procedures occurring later post-PCI and at intermediate risk. There was no significant association between interruption of antiplatelet therapy and adverse cardiac events. Among patients undergoing NCS within 1 year of PCI, perioperative ischemic and bleeding events primarily depend on the estimated surgical risk and urgency of the procedure, which are increased early after PCI. Preoperative antiplatelet interruption was not associated with an increased risk of cardiac events.

Management of calcified coronary artery bifurcation lesions.

Calcified coronary artery bifurcation lesions (CBL) remain a challenge for the interventional cardiologist. Evidence regarding treatment of CBL is minimal. Optimal plaque modification is the most important step prior to stent deployment. Provisional stenting is the preferred strategy for most bifurcation lesions. However, two-stent strategy should be considered for BL with compromised large SB (>2.5 mm) supplying a large territory, >70% SB stenosis and lesions more than 5 mm long. In this contemporary review article, we present a simplified approach to treating CBL and demonstrate the approach to specific case examples using our newly developed mobile application, BifurcAID.

Procedural and 1-year clinical outcomes of orbital atherectomy for treatment of coronary in-stent restenosis: A single-center, retrospective study.

OBJECTIVES: We evaluated the procedural and 1-year clinical outcomes of orbital atherectomy (OA) for treatment of coronary in-stent restenosis (ISR). BACKGROUND: The optimal treatment for ISR remains uncertain. While rotational and laser atherectomy have been used as neointimal debulking techniques for ISR, there have been few reports on OA for ISR. METHODS: This is a retrospective observational study of consecutive patients who underwent percutaneous coronary intervention (PCI) for ISR with OA in Mount Sinai catheterization laboratory between November 2013 and January 2018. Procedural success was defined as angiographic success without in-hospital major adverse cardiac events (MACE; the composite of all-cause death, myocardial infarction [MI], or target vessel revascularization). Clinical outcomes were assessed at 1 month and 12 months postprocedure. RESULTS: A total of 87 patients were included in the study. All 87 patients were treated with OA, after which 49 (56.3%) patients also received new drug-eluting stents. Angiographic success was achieved in 87 (100%) patients and procedural success was achieved in 79 (90.8%) patients. In-hospital MACE occurred in 8 (9.2%) patients, all due to periprocedural non-Q-wave MI. Acute lumen gain was 1.19 ± 0.57 mm after OA plus balloon angioplasty and 1.75 ± 0.50 mm after stent placement. MACE within 1 year occurred in 17 (19.5%) patients. CONCLUSIONS: OA for ISR was performed with favorable procedural and 1-year clinical outcomes. Randomized trials are warranted to determine whether OA improves the poor prognosis of patients with ISR treated without debulking.

One-year outcomes of patients undergoing complex percutaneous coronary intervention with three contemporary drug-eluting stents.

OBJECTIVES: We aimed to evaluate the 1-year outcomes of three everolimus-eluting stents (EES) for complex percutaneous coronary intervention (PCI). BACKGROUND: It is controversial whether contemporary bioresorbable-polymer drug-eluting stents (BP-DES) are associated with better outcomes compared with durable-polymer DES (DP-DES). METHODS: Patients undergoing PCI with cobalt-chromium (CoCr)-DP-EES (Xience), platinum-chromium (PtCr)-DP-EES (Promus), or PtCr-BP-EES (Synergy) at one high-volume institution between 2015 and 2017 were included. The primary endpoint was 1-year major adverse cardiac events (MACE), a composite of death, myocardial infarction, and target-vessel revascularization. Associations were also examined in patients undergoing complex PCI. Multivariable analysis was conducted to adjust for baseline differences across groups. RESULTS: We included n = 5,446 patients (CoCr-DP-EES, n = 3,177; PtCr-DP-EES, n = 1,555; PtCr-BP-EES, n = 714). Patients treated with PtCr-BP-EES had higher comorbidity burden and procedural complexity. At 1 year, MACE rates were 8.9% for CoCr-DP-EES versus 8.9% for PtCr-DP-EES versus 8.6% for PtCr-BP-EES (p = .97). The incidence of definite/probable stent thrombosis (ST) was also similar (0.6 vs. 0.4 vs. 0.3%, p = .69). Complex PCI was performed in n = 2,894/5,446 (53.1%). At 1 year, MACE rates were 11.5 versus 10.7 versus 10.3%, respectively (p = .83). The incidence of definite/probable ST was also similar (0.9 vs. 0.3 vs. 0.3%, p = .22). On multivariable analysis, stent type was not an independent predictor of MACE either in the overall or in the complex PCI population. CONCLUSIONS: We observed comparable 1-year rates of MACE and definite/probable ST in patients undergoing PCI with CoCr-DP-EES, PtCr-DP-EES, and PtCr-BP-EES. Results were unchanged among patients undergoing complex PCI. Future multicenter randomized studies should confirm and extend our findings.

Side branch fractional flow reserve after provisional stenting of calcified bifurcation lesions: The ORBID-FFR study.

OBJECTIVES: We examined the incidence of side branch (SB) compromise after provisional stenting of calcified bifurcation lesions treated with rotational atherectomy (RA) or cutting balloon angioplasty (CBA) and the utility of optical coherence tomography (OCT) to detect functionally significant SB stenoses. BACKGROUND: The comparative impact of RA versus CBA on SB compromise and functional significance remains poorly characterized. METHODS: Seventy-one consecutive patients with 71 calcified bifurcation lesions with angiographically intermediate SB stenoses were randomized to RA (n = 35) or CBA (n = 36). The primary endpoint was SB compromise defined as SB diameter stenosis ≥70%, SB dissection or thrombolysis in myocardial infarction flow grade < 3 after provisional stenting. Secondary endpoints included SB FFR in noncompromised SBs and its correlation with SB ostium area (SBOA) assessed by three-dimensional OCT. RESULTS: SB compromise after provisional stenting was observed in 7 (20.0%) lesions that underwent RA and in 9 (25.0%) lesions treated with CBA (p = .62). Mean SB FFR was 0.83 ± 0.08 and was similar between the study arms. Functionally significant SB stenosis (FFR ≤ 0.80) was detected in 17(30.9%) angiographically noncompromised SBs. SBOA after stenting was an independent predictor of FFR ≤ 0.80 (OR 0.002, 95% CI: 0.00-0.15, p = .002). The optimal cutoff value for SBOA to predict functionally significant SB stenosis was 0.76 mm2 (sensitivity 82%, specificity 89% and area under the curve 0.92, 95% CI: 0.84-0.99). CONCLUSIONS: The rates of SB compromise and functionally significant stenosis after provisional stenting of calcified bifurcation lesions were similar between two lesion preparation strategies. OCT SBOA can detect SB branches with FFR ≤ 0.80 with high sensitivity and specificity.

Outcomes of Impella-supported high-risk nonemergent percutaneous coronary intervention in a large single-center registry.

OBJECTIVES: We aimed to evaluate the early and one-year outcomes of Impella-supported high-risk nonemergent percutaneous coronary intervention (PCI). BACKGROUND: The evidence for the use of mechanical circulatory support (MCS) devices in high-risk nonemergent PCI is limited and nonconclusive. METHODS: We performed a single-center retrospective study including all patients who underwent high-risk nonemergent PCI supported by Impella 2.5/CP at our institution between January 2009 and June 2018. This patient population was propensity score matched with subjects undergoing PCI with no MCS. The primary endpoint was major adverse cardiac events (MACE: all-cause death, myocardial infarction [MI], and target lesion revascularization) at one-year follow-up. RESULTS: Two-hundred fifty patients undergoing Impella-supported nonemergent PCI were matched to 250 controls. The two groups were well balanced in terms of clinical and angiographic characteristics. Left main PCI was performed more frequently among Impella-supported patients (26% vs. 11%, p < .001), who also had numerically higher prevalence of rotational atherectomy use (44% vs. 37%, p = .10) and a higher number of vessels treated (1.8 ± 0.8 vs. 1.3 ± 0.6, p < .001), compared with controls. Impella-supported patients suffered a higher incidence of periprocedural MI (14.0% vs. 6.4%, p = .005), major bleeding (6.8% vs. 2.8%, p = .04), and need for blood transfusions (11.2% vs. 4.8%, p = .008). However, at one-year follow-up there were no differences in the rates of MACE (31.2% vs. 27.4%, p = .78) or any of its individual components between Impella-supported patients and controls. CONCLUSIONS: Although Impella-supported patients suffer a higher incidence of periprocedural adverse events (partially linked to more aggressive PCI), the incidence of one-year MACE was similar between the Impella and control group.

Cardiovascular outcomes after percutaneous coronary intervention on bifurcation lesions with moderate to severe coronary calcium: A single-center registry study.

BACKGROUND: Both target vessel calcification and target vessel bifurcation are associated with worse outcomes following percutaneous coronary intervention (PCI). Whether these entities in combination interact to influence outcomes after PCI of complex coronary disease is not known. OBJECTIVES: This study evaluated the association of target vessel bifurcation and target vessel calcification, alone and in combination, with adverse events following PCI. METHODS: Registry data from 21,165 patients who underwent PCI with drug-eluting stents (DES) between January 2009 and December 2017 were analyzed. Patients were divided into four groups according to the presence or absence of target vessel bifurcation and presence of none/mild or moderate/severe target vessel calcification on angiography. Associations between lesion groups and 1 year major adverse cardiac events (MACE) were examined using Cox regression analysis. RESULTS: At 1 year, unadjusted rates of MACE, death, myocardial infarction (MI), as well as stent thrombosis were highest in the group with both bifurcation lesion and moderate/severe calcification. After adjusting for confounders such as age, renal disease, and smoking, hazard ratios for MACE were 1.14 (95%CI 0.99-1.33) for bifurcation with none/mild calcification, 1.21 (95%CI 1.06-1.38) for no bifurcation and moderate/severe calcification, and 1.37 (95%CI 1.14-1.64) for bifurcation and moderate severe calcification, compared to patients with no bifurcation and none/mild calcification. CONCLUSIONS: The presence of a bifurcating target vessel with moderate/severe calcification is associated with a higher risk of adverse outcomes than either attribute alone. New approaches are needed to improve outcomes in this subset of patients with complex coronary artery disease.

Cusp Overlap Technique: Should It Become the Standard Implantation Technique for Self-expanding Valves?

PURPOSE OF REVIEW: Accurate imaging of the aortic root during valve implantation is crucial for proper prosthesis positioning during TAVR. The purpose of this review was to determine if routine use of the cusp-overlap view should be adopted for self-expanding valves. RECENT FINDINGS: The use of the cusp-overlap view with the Evolut, Portico, ACURATE neo/neo2, and JenaValve systems is associated with lower post-procedural new permanent pacemaker implantation rates when compared with the standard 3-cusp view, presumably due to more precise valve implantation relative to the conduction system by the non-coronary cusp. By elongating the left ventricular outflow tract and accentuating the right-non commissure in the center of the fluoroscopic view, the cusp-overlap technique allows operators to more precisely control the prosthesis implant depth during self-expanding valve deployment. While the early experience with this approach in Evolut TAVR has been promising, the results of larger studies with longer follow-up across multiple self-expanding systems are warranted.

Combined and independent impact of coronary artery calcification and inflammation on risk for adverse cardiovascular events after percutaneous coronary intervention: Results from a large single-center registry.

PURPOSE: Our study investigated the impact of coronary artery calcification (CAC) and systemic inflammation on risks for major adverse cardiovascular events (MACE) following percutaneous coronary intervention (PCI). BACKGROUND: CAC and systemic inflammation are known to be associated with an increased risk of cardiovascular events. METHODS: A total of 17,711 consecutive patients who underwent PCI in our hospital between January 1, 2009 and December 31, 2015 were categorized according to the degree of CAC (moderate/severe vs. none/mild) and high-sensitivity C-reactive protein (hsCRP) level (≥2 vs. <2 mg/L). MACE was defined as death, myocardial infarction (MI), or target vessel revascularization (TVR) occurring over 1 year. RESULTS: Within the four groups, patients with both moderate/severe CAC and elevated hsCRP (n = 1,814 [10.2%]) were older with more comorbid risk factors compared to those with moderate/severe CAC alone (n = 1,687 [9.5%]), elevated hsCRP alone (n = 7,597 [42.9%]) or neither abnormality (n = 6,613 [37.3%]). The analogous 1-year MACE rates were 21.2, 14.9, 11.5, and 7.8%, respectively (p-trend < .001). Results were unchanged after multivariable adjustment, suggesting synergistic adverse effects in patients with both CAC and elevated hsCRP. CONCLUSIONS: The presence of both moderate/severe CAC and systemic inflammation confers a synergistic effect on risk for MACE following PCI, indicating the need for novel or more intense therapeutic interventions to mitigate risk in such patients.

Impact of stent diameter on outcomes following percutaneous coronary intervention with second-generation drug-eluting stents: Results from a large single-center registry.

BACKGROUND: In patients treated with bare metal stents and first-generation drug-eluting stents (DES) smaller stent diameter (SD) has been associated with worse long term outcomes after percutaneous coronary intervention (PCI). Data on the impact of small SD on outcomes after PCI with second-generation DES is scarce. METHODS: Consecutive patients treated with second-generation DES between 2010 and 2016 were included in a single tertiary center. Patients were grouped according to SD: ≤2.50 mm, 2.75 ≤ 3.00 mm, 3.25 ≤ 3.50 mm, and >3.50 mm. One-year event rates were estimated using the Kaplan-Meier method and adjusted hazard ratios were generated using Cox regression analysis. The primary endpoint was major adverse cardiac events (MACE; death, myocardial infarction [MI], or target vessel revascularization [TVR]). RESULTS: Of the 17,607 patients who underwent PCI with second-generation DES, 32.6% (n = 5,741) had SD ≤2.5 mm, 39.1% (n = 6,890) had SD 2.75 ≤ 3.0 mm, 22.2% (n = 3,910) had SD 3.25 ≤ 3.5 mm, and 6.1% (n = 1,066) had SD >3.5 mm. At 1 year, MACE rates were 10.5%, 9.5%, 8.0%, and 8.0%, respectively, with increasing SD (p = .006). TVR rates decreased with increasing SD (7.2%, 5.8%, 4.7%, and 3.3%, respectively [p < .0001]) whereas rates of MI across SD groups were comparable (1.7%, 1.9%, 2.0%, and 1.5%, respectively [p = .60]). After multivariable adjustment, smaller SD remained associated with higher rates of MACE, TVR, and target lesion revascularization. CONCLUSION: In a large cohort of patients undergoing PCI with second-generation DES, smaller SD was associated with increased MACE, driven by higher rates of repeat revascularization. Further research into the optimal treatment of small coronary arteries is warranted.

Predictors and etiologies of 30-day readmissions in patients with non-ST-elevation acute coronary syndrome.

BACKGROUND: Despite improvements in acute care and survival after non-ST-elevation acute coronary syndrome (NSTE-ACS) hospitalization, early readmissions remain common, and have significant clinical and financial impact. OBJECTIVES: Determine the predictors and etiologies of 30-day readmissions in NSTE-ACS. METHOD: The study cohort was derived from the National Readmission Database 2014 identifying patients with a primary diagnosis of NSTE-ACS using ICD9 code. RESULTS: We identified a total of 300,269 patients admitted with NSTE-ACS; 13.4% were readmitted within 30-day. The most common cause of readmission was heart failure (HF) (15.6%), followed by a recurrent myocardial infarction (MI) (10%). Predictors of increased readmissions were age ≥ 75 years (OR: 1.34, 95% CI: 1.30-1.39), female gender (OR 1.12, 95% CI 1.09-1.16), a Charlson Comorbidity Index (CCI) >3 (OR 2.11, 95% CI: 2.04-2.18), ESRD (OR 2.01, 95% CI 1.89-2.14), CKD (OR: 1.58, 95% CI: 1.51-1.64), length of stay ≥5 days (OR: 1.51, 95% CI 1.46-1.56) and adverse events during the index admission such as AKI (OR:1.31, 95% CI: 1.25-1.36), major bleeding (OR:1.20, 95% CI: 1.12-1.24); whereas admission to a teaching hospital (OR 0.92, 95% CI 0.89-0.95) and PCI (OR 0.70, 95% CI 0.67-0.72) were associated with less likelihood of 30-day readmission. CONCLUSION: Readmission rate at 30-days is high among NSTE-ACS patients and the most common readmission etiologies are HF and recurrent MI. A CCI more than 3 and ESRD were the most significant predictors for readmission; patients undergoing PCI had less odds of readmission.

Frequency of 30-day readmission and its causes after percutaneous coronary intervention in acute myocardial infarction complicated by cardiogenic shock.

BACKGROUND: Survival after percutaneous coronary intervention (PCI) in acute myocardial infarction complicated by cardiogenic shock (AMI-CS) has increased over the years. Short-term readmission rates in this high-risk population remain unknown. METHODS: We queried the United States (U.S.) Nationwide Readmission Database (NRD) from January 2010 to November 2014 using the International Classification of Diseases-Ninth edition, Clinical Modification (ICD-9 CM) codes to identify all patients ≥18 years readmitted within 30 days after surviving an index hospitalization for PCI in AMI-CS. Incidence, etiologies, and predictors of 30-day readmission were analyzed. RESULTS: Among 46,435 patients who survived to discharge after PCI in AMI-CS, 9,020 (19.4%) were readmitted within 30 days. Median time to 30-day readmission was 11 days. Cardiac conditions were the most common causes of readmission (57.8%). Heart failure was the leading readmission diagnosis (24.8%). Private insurance including HMO and self-pay were predictive of lower 30-day readmission. Among other covariates, female sex, comorbidities such as heart failure, atrial fibrillation, in-hospital complications such as major bleeding, sepsis, respiratory complications, AKI requiring dialysis, utilization of mechanical circulatory support (IABP and ECMO) were independently predictive of 30-day readmission. Trend analysis showed decline in 30-day readmission rates from 21.9% in 2010 to 17.9% in 2014 (ptrend < 0.001). CONCLUSION: In this large real-world database, one in five patients receiving PCI in AMI-CS was readmitted within 30 days after discharge. Cardiac conditions were the most common causes of readmission. Insurance type had significant influence on 30-day readmission.

Predictors of side branch compromise in calcified bifurcation lesions treated with orbital atherectomy.

OBJECTIVES: The aim of the study was to identify the predictors of side branch (SB) compromise in severely calcified bifurcation lesions treated with orbital atherectomy (OA). BACKGROUND: SB compromise remains a major complication of bifurcation lesion percutaneous coronary intervention (PCI). Higher prevalence of lipid-rich plaques and spotty calcification by optical coherence tomography (OCT) and SB ostial stenosis by angiography have been previously suggested as predictors of SB occlusion after main vessel (MV) stenting. METHODS: Patients with chronic stable angina and severely calcified bifurcation lesions, in whom provisional stenting strategy was planned, were enrolled in the study. OA was used for lesion preparation in all cases. OCT imaging of the MV was performed before and after stenting. SB compromise was defined as a composite of SB occlusion (TIMI flow grade ≤ 2) and SB intervention after MV stenting. RESULTS: Thirty stable CAD patients with 30 severely calcified bifurcation lesions were included in the study. Twelve patients (40%) had a compromised SB after MV stenting. Compromised SB was characterized by a greater angiographic diameter stenosis (55.4 ± 8.1% vs. 35.0 ± 14.4%, P < 0.01) and a smaller minimal lumen diameters (0.79 ± 0.17 vs. 1.12 ± 0.30 mm, P = 0.002) before PCI compared to noncompromised SB. The prevalence of OCT lipid-rich plaques was low and did not differ between the groups (18 vs. 19%, P = 0.68). There was no difference in other OCT plaque characteristics including the presence of spotty calcification. CONCLUSION: The severity of SB ostial disease and not MV plaque morphology contributed to SB compromise in severely calcified bifurcation lesions.

Late-term safety and effectiveness of everolimus-eluting stents in chronic total coronary occlusion revascularization: Final 4-year results from the evaluation of the XIENCE coronary stent, Performance, and Technique in Chronic Total Occlusions (EXPERT CTO) multicenter trial.

BACKGROUND: Limited study has detailed the late-term safety and efficacy of chronic total coronary occlusion (CTO) revascularization among multiple centers applying modern techniques and with newer-generation drug-eluting stents. METHODS: Among 20 centers, 222 patients enrolled in the XIENCE coronary stent, performance, and technique (EXPERT) CTO trial underwent CTO percutaneous coronary intervention (PCI) with everolimus-eluting stents (EES). Through planned 4-year follow-up, the primary composite endpoint of major adverse cardiac events (MACE; death, myocardial infarction [MI] and target lesion revascularization) and rates of individual component endpoints and stent thrombosis were determined. RESULTS: Demographic, lesion, and procedural characteristics included prior bypass surgery, 9.9%; diabetes, 40.1%; lesion length, 36.1 ± 18.5 mm; and stent length, 51.7 ± 27.2 mm. By 4 years, MACE rates were 31.6 and 22.4% by the pre-specified ARC and per-protocol definitions, respectively. Clinically-indicated target lesion revascularization at 4 years was 11.3%. In landmark analyses of events beyond the first year of revascularization, the annualized rates of target vessel-related MI and clinically-indicated target lesion revascularization were 0.53 and 1.3%, respectively. Through 4 years, the cumulative definite/probable stent thrombosis rate was 1.7% with no events occurring beyond the initial year of index revascularization. CONCLUSIONS: In a multicenter registration trial representing contemporary technique and EES, these results demonstrate sustained long-term safety and effectiveness of EES in CTO percutaneous revascularization and can be used to inform shared decision making with patients being considered for CTO PCI relative to late safety and vessel patency.

Temporal trends of survival and utilization of mechanical circulatory support devices in patients with in-hospital cardiac arrest secondary to ventricular tachycardia/ventricular fibrillation.

BACKGROUND: Pulseless ventricular tachycardia/ventricular fibrillation (VT/VF) is the initial rhythm in a third of in-hospital cardiac arrest patients. Mechanical circulatory support (MCS) device use remains poorly understood in this population. METHODS: We conducted an observational analysis of temporal trends in the utilization of MCS in VT/VF IHCA between January 2008 and December 2014 utilizing the Nationwide Inpatient Sample (NIS) database. Using multivariable analysis, we assessed factors associated with MCS use and survival to discharge. RESULTS: Among 151,628 hospitalizations with VT/VF IHCA, 14,981 (9.9%) received MCS. Intra-aortic balloon pump (IABP) was the most commonly used MCS (9.1%). From 2008 to 2014, there was significant increase in the utilization of MCS (8.7-11%; ptrend < 0.0001). On multivariable analysis, there was 12-fold increase and three-fold increase in the utilization of PVAD and ECMO respectively; however, there was no significant change in the use of IABP. Over the seven-year sample period, there was significant increase in the overall survival to hospital discharge (35.4-43.5%; ptrend < 0.0001). Survival to hospital discharge increased in both MCS and non-MCS groups. CONCLUSION: There was significant increase in utilization of MCS after VT/VF IHCA during the study period. IABP was the most commonly utilized MCS. The survival to hospital discharge increased in the overall study population including both MCS and non-MCS groups. Future studies are needed to identify patient population most likely to benefit from the use of MCS after VT/VF IHCA.

The prevalence, predictors and outcomes of guideline-directed medical therapy in patients with acute myocardial infarction undergoing PCI, an analysis from the PROMETHEUS registry.

OBJECTIVES: To investigate the prevalence, predictors and associations between guideline-directed medical therapy (GDMT) and clinical outcomes in acute myocardial infarction (AMI) patients undergoing percutaneous coronary intervention (PCI) from eight academic centers in the United States. BACKGROUND: Evidence for GDMT in patients with AMI comes from randomized controlled trials. The use of GDMT in clinical practice is unknown in this setting. METHODS: PROMETHEUS is a multicenter observational registry comprising 19,914 patients with acute coronary syndrome (ACS) undergoing PCI. Patients with AMI were divided into two groups based on the prescription of GDMT or not (non-GDMT) at discharge. GDMT was defined according to American College of Cardiology/American Heart Association (ACC/AHA) class I recommendations, specifically, dual antiplatelet therapy, statin and beta-blocker for all AMI patients, and additional ACEI/ARB in patients with left ventricular ejection fraction (LVEF) less than 40%, hypertension, diabetes mellitus (DM) or chronic kidney disease (CKD). The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of all-cause death, MI, stroke or unplanned target vessel revascularization (TVR) at 1 year. RESULTS: Out of 4,834 patients with AMI, 3,356 (69.4%) patients were discharged on GDMT. Patients receiving GDMT were more often younger and male. Compared with non-GDMT patients, GDMT patients had a significantly lower frequency of comorbidities. Predictors of greater GDMT prescription at discharge were ST-segment elevation myocardial infarction (STEMI), and increased body mass index (BMI), whereas hypertension, prior PCI, anemia and CKD were associated with less GDMT prescription. At 1 year, the use of GDMT was associated with a significantly lower incidence of MACE (13.7% vs. 22.5%; adjusted HR 0.68; 95%CI 0.58-0.80; P < 0.001), death (3.7% vs. 9.4%; adjusted HR 0.61; 95%CI 0.46-0.80; P < 0.001), and unplanned TVR (8.4% vs. 11.3%; adjusted HR 0.76; 95%CI 0.61-0.96; P = 0.020). However, there were no significant differences in the incidence of MI (4.3% vs. 7.0%; adjusted HR 0.75; 95%CI 0.56-1.01; P = 0.056), stroke (1.5% vs. 2.0%; adjusted HR 0.79; 95%CI 0.47-1.34; P = 0.384) between the two groups. CONCLUSION: In a contemporary practice setting in the United States, GDMT was utilized in just over two-thirds of AMI patients undergoing PCI. Predictors of GDMT prescription at discharge included STEMI, BMI and absence of hypertension, CKD, anemia or prior PCI. Use of GDMT was associated with significantly lower risk of 1-year MACE and mortality.

Associations between use of prasugrel vs clopidogrel and outcomes by type of acute coronary syndrome: an analysis from the PROMETHEUS registry.

We sought to investigate the utilization of prasugrel and its association with outcomes relative to clopidogrel in three typical subgroups of ACS in a real-world setting. Prasugrel is superior to clopidogrel for reducing risk of ischemic events in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI), but is associated with an increased risk of bleeding complications. PROMETHEUS was a retrospective multicenter observational study of 19,913 ACS patients undergoing PCI from 8 centers in the United States between 2010 and 2013. Major adverse cardiovascular events (MACE) were defined as a composite of all-cause mortality, myocardial infarction, stroke or unplanned revascularization. The study cohort included 3285 (16.5%) patients with ST-segment elevation myocardial infarction (STEMI), 5412 (27.2%) patients with NSTEMI and 11,216 (56.3%) patients with unstable angina (UA). The frequency of prasugrel use at discharge was highest in STEMI and lowest in UA patients, 27.3% versus 22.2% versus 18.9% (p < 0.001). Use of prasugrel vs clopidogrel was associated with a lower rate of MACE in STEMI, NSTEMI, or UA at 1 year, but the differences were attenuated for all groups except for patients with UA (adjusted HR 0.81, 95% CI 0.69-0.94, p = 0.006) after propensity adjusted analysis. After adjustment, there was no difference in bleeding risk between prasugrel and clopidogrel for all groups at 1 year. STEMI patients were more likely to receive prasugrel compared to NSTEMI and UA patients. Prasugrel was associated with reduced adverse outcomes compared with clopidogrel in unadjusted analyses, findings that were largely attenuated upon adjustment and suggest preferential use of prasugrel in low vs high risk patients.