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Background: The number of octogenarians referred to percutaneous coronary interventions (PCI) is rising steadily. The prevalence and prognostic impact of complex PCI (CPCI) in this vulnerable population has not been fully evaluated., Methods: Patients ≥80 years old who underwent PCI between 2012 and 2019 at Mount Sinai Hospital were included. Patients were categorized based on PCI complexity, defined as the presence of at least one of the following criteria: use of atherectomy, total stent length ≥60 mm, ≥3 stents implanted, bifurcation treated with at least 2 stents, PCI involving ≥3 vessels, ≥3 lesions, left main, saphenous vein graft or chronic total occlusion. The primary outcome was major adverse cardiovascular events (MACE), a composite of all-cause death, myocardial infarction (MI), or target-vessel revascularization (TVR), within 1 year after PCI. Secondary outcomes included major bleeding., Results: Among 2657 octogenarians, 1387 (52%) underwent CPCI and were more likely to be men and to have cardiovascular risk factors or comorbidities. CPCI as compared with no-CPCI was associated with a higher 1-year risk of MACE (16.6% vs. 11.1%, adjusted HR 1.3, 95% CI 1.06-1.77, p value 0.017), due to an excess of MI and TVR, and major bleeding (10% vs. 5.8%, adjusted HR 1.64, 95% CI 1.20-2.55, p value 0.002)., Conclusions: Among octogenarians, CPCI was associated with a significantly higher 1-year risk of MACE, due to higher rates of MI and TVR but not of all-cause death, and of major bleeding. Strategies to reduce complications should be implemented in octogenarians undergoing CPCI., (© 2024 Wiley Periodicals LLC.)

Background: Among patients undergoing percutaneous coronary intervention (PCI), in-stent restenosis (ISR) is related with a worse prognosis, while higher body mass index (BMI) values are associated with better outcomes. It is unclear whether the prognostic impact of ISR varies in function of BMI., Methods: Patients undergoing PCI at a large center from 2012 to 2019 not presenting with an acute myocardial infarction (MI) were included. Subjects with BMI < 18.5 kg/m 2 or treated with bare metal stents were excluded. Patients were stratified according to type of lesion treated (ISR vs. no-ISR) and into four BMI categories: normal weight (BMI 18.5-25 kg/m 2 ), overweight (25.0-29.9 kg/m 2 ), class I obesity (30.0-34.9 kg/m 2 ), class II-III obesity (≥35.0 kg/m 2 ). The primary outcome was major adverse cardiovascular events (MACE), a composite of all-cause death, MI, and target vessel revascularization (TVR) at 1 year., Results: Out of 16,234 patients, 3694 (23%) underwent PCI for ISR. ISR as compared to no-ISR was associated with a consistent increased risk of MACE within the normal weight (18.8% vs. 7.8%, adj. hazard ratio (HR): 1.99, 95% confidence interval [CI]: 1.51-2.64), overweight (19.1% vs. 6.4%, adj. HR: 2.35, 95% CI: 1.91-2.88), class I obesity (18.3% vs. 6.8%, adj. HR: 1.95, 95% CI: 1.47-2.57), and class II-III obesity (16.4% vs. 7.4%, adj. HR: 1.61, 95% CI: 1.09-2.37) groups (interaction p-value: 0.192). The ISR-related risks were mostly driven by an excess of TVR., Conclusions: At 1 year, ISR was associated with an increased risk of MACE irrespective of BMI, mostly due to an excess of TVR after ISR., (© 2024 Wiley Periodicals LLC.)

Background: Peripheral artery disease (PAD) is associated with worse outcomes after percutaneous coronary intervention (PCI). The aim of this study was to assess the prognostic impact of PAD according to high bleeding risk (HBR) status., Methods: Consecutive patients undergoing PCI with drug-eluting stent implantation at a tertiary-care center (Mount Sinai Hospital) between 2012 and 2019 were stratified according to HBR and PAD status. The primary outcome was major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), and stroke 1 year after PCI. Secondary outcomes included major bleeding., Results: Out of 16,750 patients, 43% were HBR and 57% were no-HBR. Within the two groups, PAD patients were 14% and 6%, respectively, and were more likely to have comorbidities and to undergo complex PCI than no-PAD patients. Within the HBR group, PAD was associated with an increased risk of MACE (11.4% vs. 7.3%, hazard ratio [HR]: 1.59, 95% confidence interval [CI]: 1.27-1.99, p < 0.001) and a numerical nonsignificant increase of major bleeding (8.5% vs. 6.9%, HR: 1.25, 95% CI: 0.98-1.59, p = 0.066) as compared with no-PAD. Among no-HBR patients, rates of MACE and major bleeding were numerically but not significantly higher in the PAD group. After multivariable adjustment, PAD was no longer a predictor of adverse outcomes, irrespective of HBR status., Conclusions: At 1-year after PCI, PAD was associated with increased 1-year risks of MACE in HBR patients. After adjustment for cardiovascular risk factors and comorbidities, the effect of PAD on adverse events was largely attenuated., (© 2024 Wiley Periodicals LLC.)

Background: Patients with chronic kidney disease (CKD) are at higher risk of ischemic and bleeding events after percutaneous coronary intervention (PCI). Complex PCI (CPCI) is associated with higher rates of ischemic complications. Whether CPCI confers an additive risk of adverse events in CKD patients is unclear., Methods: Patients who underwent PCI at a single tertiary-care-center between 2012 and 2019 were stratified by CKD status and CPCI. The primary outcome was major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), and target-vessel revascularization (TVR) at 1-year follow-up. Secondary outcomes included the individual components of the primary outcome and major bleeding., Results: Out of 15,071 patients, 4537 (30.1%) had CKD and 10,534 (69.9%) had no CKD. Patients undergoing CPCI were 1151 (25.4%) and 2983 (28.3%) in the two cohorts, respectively. At one year, CPCI compared with no CPCI was associated with higher risk of MACE in both CKD (Adj. HR 1.72, 95% confidence interval [CI] 1.45-2.06, p < 0.001) and no-CKD patients (Adj. hazard ratios [HR] 2.19, 95% CI 1.91-2.51, p < 0.001; p of interaction 0.057), determined by an excess of death, MI and TVR in CKD patients and of TVR and MI only in no-CKD. CPCI was related with a consistent increase of major bleeding in the CKD (Adj. HR 1.49, 95% CI 1.18-1.87, p < 0.001) and no-CKD group (Adj. HR 1.23, 95% CI 0.98-1.54, p = 0.071, p of interaction 0.206)., Conclusion: At 1-year follow-up, CPCI was associated with higher risk of MACE and major bleeding irrespective of concomitant CKD. CPCI predicted mortality in CKD patients only., (© 2023 Wiley Periodicals LLC.)

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 mm 2 for 23 mm or >546 mm 2 for 26 mm) were compared to NAS (338-430 mm 2 for 23 mm or 430-546 mm 2 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., (© 2022 Wiley Periodicals LLC.)

Objectives: We assessed the impact of conventional delivery system (DS) insertion technique on "Hat-marker" orientation/commissural alignment in patients who underwent transcatheter aortic valve replacement (TAVR) in the Evolut Low Risk Trial CT substudy versus a modified technique., Background: Unlike surgical aortic valve replacement, where alignment of the surgical valve commissures with native commissures can be achieved virtually 100% of the time, commissural alignment during TAVR is not achieved consistently. This may subsequently impact the feasibility of both coronary access and reintervention after TAVR., Methods: "Hat-marker" orientations during deployment were characterized as outer curve (OC), center front (CF), inner curve, and center back. Severe commissure-to-CA overlap was 0-20°. "Hat-marker" orientations and CA overlap were compared to 240 patients from a single center using the modified 3-o'clock flush port DS technique., Results: In the CT substudy in which conventional DS insertion was performed (flush port at 12 o'clock); 154/249 had both analyzable CT and procedural fluoroscopy to validate "Hat-marker" to C-tab/commissural orientation. On post-TAVR CT, Evolut valve commissural orientation and coronary artery (CA) ostia were identified. Compared to conventional DS technique in the CT substudy, the modified technique had higher rates of "Hat-marker" at OC/CF orientation, improved commissural alignment and reduced severe CA overlap; (left main, 14.2 vs. 27.9%; right coronary artery, 11.7 vs. 27.3% both, 5.0 vs. 13.6%; 1 or both CA, 20.8 vs. 41.6%, all p < 0.01)., Conclusions: The modified technique improved initial "Hat-marker" orientation during Evolut deployment and resulted in better commissural alignment and reduced CA overlap., (© 2021 Wiley Periodicals LLC.)

Objectives: To assess the efficacy and safety of excimer laser coronary atherectomy (ELCA), as well as, the long-term outcomes and the factors associated with ELCA failure in uncrossable lesions., Background: Uncrossable lesions constitute a challenge for percutaneous coronary intervention., Methods: This multicenter registry included 126 patients with 126 uncrossable lesions. Study endpoints were ELCA success, technical success and a composite of cardiac death, myocardial infarction (MI), and target-lesion revascularization (TLR) on follow-up. Predictors of ELCA failure were analyzed., Results: Moderate or severe calcification was present in 79 (62.7%) of the lesions and 58 (46%) were a chronic total occlusion. ELCA success was obtained in 103 (81.8%) patients. Rotational atherectomy was attempted as bailout in 21 out of 23 ELCA failure (91.3%), being successful in 14 (66.7%) of them. Finally, technical and procedural success were achieved in 114 (90.5%) and 110 (87.3%) of the patients. Severe calcification was independently associated with ELCA failure (OR: 3.73, 95% CI: 1.35-10.32; p = .011). Two (1.6%) patients died (one after a stroke and another patient because of heart failure), 4 (3.2%) developed a non-Q MI without clinical consequences and 1 (0.8%) patient had a Q-MI. Other complications were ventricular tachycardia/fibrillation (n = 2; 1.6%) and flow-limiting dissection (n = 1, 0.8%). At follow-up (median 424 days), 3 (2.4%) patients died (1 (0.8%) from cardiovascular cause) and 15 (11.9%) required TLR., Conclusions: In our multicenter experience, ELCA use demonstrated to be safe and reasonably effective with a rate of events on follow-up relatively low. Severe calcification was associated with ELCA failure., (© 2020 Wiley Periodicals LLC.)

Objectives: To evaluate and compare characteristics and clinical outcomes of percutaneous coronary intervention (PCI) among target vessel types in patients with a prior coronary artery bypass graft (CABG) surgery., Background: Patients with a prior CABG often require repeat revascularization with PCI. Graft PCI has been associated with worse outcomes compared to native vessel PCI, yet the optimal PCI strategy in prior CABG patients remains unknown., Methods: We stratified prior CABG patients who underwent PCI at a tertiary-care center between 2009 and 2017 by target vessel type: native vessel, venous graft, and arterial graft. The primary outcome of major adverse cardiac events (MACE) was a composite of all-cause death, myocardial infarction, stent thrombosis, or target vessel revascularization up to 1 year post-PCI., Results: Prior CABG patients (n = 3983) represented 19.5% of all PCI interventions during the study period. PCI was most frequently performed on native vessels (n = 2928, 73.5%) followed by venous (n = 883, 22.2%) and arterial grafts (n = 172, 4.3%). Procedural success and complications were similar among the groups; however, slow- and no-reflow phenomenon was more common in venous graft PCI compared to native vessel PCI (OR 4.78; 95% CI 2.56-8.95; p < 0.001). At 1 year, there were no significant differences in MACE or in its individual components., Conclusions: Target vessel choice did not appear to affect MACE at 1 year in a large cohort of patients with prior CABG undergoing PCI. Whether PCI of surgical grafts versus native arteries truly results in similar outcomes warrants further investigation in randomized controlled trials., (© 2021 Wiley Periodicals LLC.)

Objectives: To describe the incidence, predictors, and clinical impact of permanent pacemaker insertion (PPI) following transcatheter aortic valve replacement (TAVR) in women., Background: Data on pacemaker insertion complicating TAVR in women are scarce., Methods: The Women's International Transcatheter Aortic Valve implantation (WIN-TAVI) is a prospective registry evaluating the safety and efficacy of TAVR in women. We included patients without preprocedural pacemakers and divided them into two groups: (1) PPI and (2) no-PPI. We identified PPI predictors using logistic regression and studied its clinical impact on the Valve Academic Research Consortium (VARC)-2 efficacy and safety endpoints., Results: Out of 1019 patients, 922 were included in the analysis. Post-TAVR PPI occurred in 132 (14.3%) patients. Clinical and procedural characteristics were similar in both groups. Pre-existing right bundle branch block (RBBB) was associated with a high risk of post-TAVR PPI (OR 3.62, 95% CI 1.85-7.06, p < 0.001), while implantation of balloon-expandable prosthesis was associated with a lower risk (OR 0.47, 95% CI 0.30-0.74, p < 0.001). Post-TAVR PPI prolonged in-hospital stay by a median of 2 days (11 [9-16] days in PPI vs. 9 [7-14] days in no-PPI, p = 0.005), yet risks of VARC-2 efficacy and safety endpoints at 1 year were similar in both groups ( adj HR 0.95, 95% CI 0.60-1.52, p = 0.84 and adj HR 1.22, 95% CI 0.83-1.79, p = 0.31, respectively)., Conclusion: Pacemaker implantation following TAVR is frequent among women and is associated with pre-existing RBBB and valve type. PPI prolongs hospital stay, albeit without any significant impact on 1-year outcomes., (© 2021 Wiley Periodicals LLC.)

Background: Women with acute coronary syndrome (ACS) generally present with more comorbidities and experience worse clinical outcomes compared with males. However, it is unclear whether this represents genuine sex-related difference or stems from clinical, procedural and socioeconomic factors., Methods: We analyzed consecutive patients undergoing percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI), non-STEMI or unstable angina at a single tertiary-care center. Exclusion criteria were unknown sex, age < 18 years and PCI with bare metal stent or without stent placement. The study population was stratified according to sex. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE) defined as the composite of death, spontaneous myocardial infarction, or stroke at 1 year. Secondary endpoints were individual components of MACCE, target vessel revascularization (TVR) and clinically significant bleeding., Results: Of the 7362 patients included, 5031 (68.3%) were men and 2331 (31.7%) women. Women were older and presented with a higher burden of comorbidities while men had more complex coronary anatomy. The incidence of 1 year MACCE was significantly higher among women (8.0% versus 5.6%; p < 0.01) compared to men. Women also experienced a higher rate of bleeding (2.3% vs. 1.4%; p = 0.02) while there were no differences between groups in terms of TVR (8.1% vs. 7.8%; p-value = 0.83). Differences in outcomes were attenuated after multivariable adjustment. Findings were consistent across ACS subgroups., Conclusions: In a contemporary ACS population treated with drug-eluting stents, women experienced a higher crude rate of 1-year MACCE. This was no longer apparent after accounting for baseline imbalances., (© 2021 Wiley Periodicals LLC.)

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., (© 2020 Wiley Periodicals LLC.)

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., (© 2020 Wiley Periodicals LLC.)

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., (© 2020 Wiley Periodicals LLC.)

Background: High-sensitivity C-reactive protein (hsCRP) predicts outcomes after percutaneous coronary intervention (PCI)., Objective: We studied the prevalence and prognostic impact of hsCRP elevation according to age in men and women undergoing PCI., Methods: We included patients undergoing PCI at our center from 2010 until 2017, excluding those with myocardial infarction (MI) on presentation, neoplastic disease and hsCRP >10 mg/L at baseline. Elevated hsCRP was defined as >3 mg/L. The outcome of interest was major adverse cardiac events (MACE) consisting of all-cause death, MI and target vessel revascularization. The association between hsCRP elevation and outcomes was assessed using adjusted Cox models., Results: 10,432 men and 4,345 women were included. Elevation of hsCRP was present in 25.7% of men and 37.0% of women (p < .01). In men, prevalence of hsCRP elevation was stable across age strata (p trend  = .42). In women, hsCRP elevation was most prevalent in patients <50 years (44.6%) and decreased stepwise with increasing age (p trend  < .001). After stratifying the population into age quartiles (Q1: <59 years, Q2: 59-66 years, Q3: 67-74 years, Q4: ≥75 years), hsCRP elevation was associated with increased risk of MACE across all age groups in men (HR [95% CI] Q1: 1.49 [1.12-1.98]; Q2: 1.51 [1.21-2.06]; Q3: 1.76 [1.27-2.51]; Q4: 1.43[1.03-1.97]). In women, hsCRP elevation was associated with increased risk of MACE only among older patients (HR [95% CI] Q1: 1.08 [0.64-0.82]; Q2: 1.52 [0.93-2.46]; Q3: 1.65 [1.08-2.50]; Q4: 1.52 [1.02-1.28])., Conclusion: Among patients undergoing PCI, prevalence and prognostic value of hsCRP elevation were age-dependent exclusively in women., (© 2020 Wiley Periodicals LLC.)

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., (© 2020 Wiley Periodicals LLC.)

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., (© 2020 Wiley Periodicals, Inc.)

Background/objectives: Clinicians use validated scores to risk-stratify patients undergoing transcatheter aortic valve replacement (TAVR). However, evaluation by the Heart Team often deems patients to be at higher risk than their formal scores suggest. We sought to assess clinical outcomes of TAVR patients defined as high-risk by the Heart Team's assessment versus the patient's logistic EuroSCORE (LES)., Methods: The BRAVO-3 trial randomized patients at high risk (LES ≥ 18, or deemed inoperable by the Heart Team) to TAVR with periprocedural anticoagulation with unfractionated heparin versus bivalirudin. Endpoints included net adverse cardiac events (NACE: the composite of all-cause mortality, MI, stroke, or bleeding), major adverse cardiovascular events (MACE: death, MI, or stroke), the individual components of MACE, major vascular complications, BARC ≥ 3b bleeding and VARC life-threatening bleeding at 30 days. We compared patients deemed high-risk based on LES ≥ 18 versus high-risk by the Heart Team despite lower LES., Results: A total of 467/800 (58.4%) patients were deemed high-risk by the Heart Team despite LES < 18. After multivariable analysis, there were no differences in the odds of endpoints between groups (NACE, OR LES≥18 : 1.32, 95% CI 0.86-2.02, p = .21; MACE, OR LES≥18 : 1.27, 95% CI 0.72-2.25, p = .41; major vascular complications, OR LES≥18 : 0.97, 95% CI 0.65-1.44, p = .88; BARC ≥3b, OR LES≥18 : 1.38, 95% CI 0.82-2.33, p = .23; and VARC life-threatening bleeding, OR LES≥18 : 0.99, 95% CI 0.69-1.41, p = .95)., Conclusion: Patients undergoing TAVR and labeled high-risk by LES ≥ 18 or Heart Team assessment despite LES < 18 have comparable short-term outcomes. Assignment of high-risk status to over 50% of patients is attributable to Heart Team's clinical assessment., (© 2020 Wiley Periodicals, Inc.)

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., (© 2019 Wiley Periodicals, Inc.)

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., (© 2020 Wiley Periodicals, Inc.)

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%; p trend  < 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%; p trend  < 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., (© 2019 Wiley Periodicals, Inc.)

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 (p trend  < 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., (© 2019 Wiley Periodicals, Inc.)

Objectives: The Multi-center Prospective Study to Evaluate Outcomes of Moderate to Severely Calcified Coronary Lesions (MACE-Trial) was designed to provide further insight on the impact of calcification on procedural and long-term percutaneous coronary intervention outcomes., Background: Prior studies evaluating the impact of lesion calcification on percutaneous coronary intervention outcomes are limited by: retrospective nature, pooled data from multiple studies, or lack of specificity around calcification with only operator assessment and without core lab evaluation., Methods: The MACE-Trial was a prospective, multicenter, observational clinical study that enrolled 350 subjects at 33 sites from September 2013 to September 2015. Core lab assessed subject stratification by lesion calcification (none/mild [N = 133], moderate [N = 99], and severe [N = 114]). Endpoints were lesion success, procedural success, and 1-year major adverse cardiac events (MACEs)., Results: Presence of severe calcification had significant impact on lesion success ([83.3%] versus none/mild calcification [94.7%, P = 0.006]) and procedural success ([86.8%] versus moderate [95.0%, P = 0.028], and none/mild [97.7%, P = 0.001]). 1-year MACE rates were associated with presence of calcification in subjects with none/mild (4.7%), moderate (8.7%), and severe (24.4%) (P < 0.001) calcification; however, no difference was noted between none/mild and moderate (P = 0.237). The risk adjusted multivariable model identified severe calcification and decreasing eGFR as predictors of 30-day and 1-year MACE., Conclusions: In this prospective study, patients with severe calcification had significantly worse outcomes compared to those without; however, unlike previous retrospective studies, moderate calcium resulted in similar outcomes as none/mild calcium., Clinical Trial Registration: URL: https://clinicaltrials.gov/ct2/show/NCT01930214. Unique Identifier: NCT01930214., (© 2019 Wiley Periodicals, Inc.)

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., (© 2018 Wiley Periodicals, Inc.)

Severe coronary artery calcification (CAC) increases the complexity of percutaneous coronary intervention (PCI) by inhibiting optimal stent expansion, leading to an increased risk of death, myocardial infarction, repeat revascularization, and stent thrombosis. Coronary atherectomy modifies and debulks calcified plaque to facilitate PCI. Although there is no clear consensus, and further studies are needed, the decision to perform atherectomy should be based upon the presence of fluoroscopic CAC or with the use of intravascular imaging. The management of CAC in the modern era relies on rotational and orbital atherectomy to prepare the lesion to facilitate stent delivery and optimal expansion. While the two technologies differ in equipment, technique, and mechanism of action, the available literature suggests similar efficacy and safety of the two systems, although head-to-head comparisons are limited. While rotational and orbital atherectomy have been shown to have excellent procedural success in terms of facilitating stent delivery, no system has been shown to reduce long-term major adverse cardiovascular events, although the definitive trial for orbital atherectomy has not been completed. Additional trials are needed to find the population who would derive the most benefit of atherectomy and to compare the two systems in a prospective manner., (© 2017 Wiley Periodicals, Inc.)

Objectives: We sought to determine the prevalence, predictors, and clinical impact of target lesion calcification in patients undergoing percutaneous coronary intervention (PCI) with newer generation drug-eluting stents (DES) and devices., Background: Coronary calcification is independently associated with adverse outcomes following PCI. While newer DES and contemporary devices are considered safer and more efficacious, their influence on outcomes following PCI of heavily calcified lesions is unknown., Methods: We performed a retrospective analysis of a large, multiethnic cohort of patients undergoing PCI with new generation DES at an academic center between 2009 and 2013. Coronary calcification was qualitatively assessed as none/mild, moderate, or severe. Independent demographic, clinical, and anatomic predictors of moderate/severe calcification were identified using logistic regression. Associations between coronary calcification and 1-year MACE (death, myocardial infarction, or target vessel revascularization) were examined using Cox modeling., Results: Compared to patients with none/mild (n = 10,180; 82.0%), those with moderate (n = 1,271; 10.0%) or severe (n = 994; 8.0%) calcification were older, more often Caucasian, had more complex target lesions, and worse renal function. The strongest demographic, clinical, and anatomic correlates of moderate/severe calcification were age, Caucasian race, renal dysfunction, lesion length, and left main location. Unadjusted MACE rates among those with none/mild, moderate, and severe calcification were 8.3, 14.6, and 17.8%, respectively (P < 0.001). After multivariable adjustment, the hazard ratio (95% CI) for MACE associated with moderate or severe coronary calcification was 1.63., Conclusions: Target lesion calcification remains independently associated with adverse outcomes in patients treated with newer generation DES and modern devices., (© 2017 Wiley Periodicals, Inc.)

Objectives: The aim of this study was to identify the predictors of side branch (SB) ostial stenosis developed after provisional stenting of the main vessel (MV) using optical coherence tomography (OCT)., Background: Provisional stenting remains the main approach to treatment of bifurcation lesions; however, it may result in the narrowing of SB ostium. There is little information about underlying plaque morphology of the MV lesion and its potential impact on the SB after provisional stenting., Methods: Patients with stable coronary disease with angiographic MV lesion not involving SB were included in a prospective single center study. The primary outcome was significant SB ostium stenosis (SBOS), defined as residual stenosis of >50% after MV stenting., Results: Thirty bifurcation lesions in 30 patients were analyzed in the study. Poststenting significant SBOS was observed in 30% of patients. The MV lesions with SBOS > 50% were characterized by a higher prevalence of lipid rich plaques (100 vs. 64%, p = 0.040) and spotty calcifications (60 vs. 0%, p = 0.005). Maximal lipid arcs were greater (257° vs. 132°, p = 0.001) and lipid volume index was higher (1380 vs. 574, p = 0.012) in the SBOS >50% group. Multivariate logistic regression analysis identified maximal lipid arc (odds ratio (OR): 1.014, p = 0.038) and the presence of lipid plaque contralateral to SB ostium (OR: 8.14, p = 0.046) before stenting as independent predictors of significant SBOS after PCI., Conclusions: High lipid content of the MV lesion and a contralateral location of lipid in the bifurcation area may contribute to SBOS after provisional stenting. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Background: In the drug eluting stent (DES) era, repeat in-stent restenosis (ISR) of the same coronary lesion, despite percutaneous coronary intervention (PCI), is a rare but challenging problem that has not been reported. We aim to describe what we propose as the occurrence of "resistant"-ISR (R-ISR) in the DES era, including angiographic patterns and outcomes., Methods: We defined R-ISR as the recurrence of an ISR episode after successful treatment of the same lesion. We identified 276 consecutive patients with 291 lesions who had R-ISR between May 2003 and June 2012. Quantitative coronary angiography (QCA) was performed for the first and second ISR episodes. Outcomes at one year, including death, myocardial infarction (MI), and target lesion failure (TLF), were analyzed., Results: Patients with R-ISR had a high frequency of diabetes (62%), chronic kidney disease (39%), bifurcation lesions (51%), and moderate to severe calcified lesions (52%). The most common pattern of R-ISR was focal (77%). R-ISR lesions were treated with DES implantation (55%) or balloon-only strategy (45%). The mortality rate and TLF at 2-years were 9.3% and 51% respectively. The overall 2-year TLF rate did not vary with the originally implanted stent, angiographic pattern (focal versus diffuse), or revascularization strategy., Conclusions: R-ISR appears to consist predominantly of focal lesions and occurs in patients at high clinical and angiographic risk, conceivably owing to their unique diabetic and coronary calcification profile. Clinical outcomes are suboptimal irrespective of angiographic pattern or treatment strategy, indicating the recalcitrant nature of the disease, and need for aggressive treatment of cardiovascular risk factors and novel interventional approaches. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Background: Randomized clinical trials evaluating the role of thrombus aspiration (TA) in patients undergoing primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) have yielded contrasting results. Therefore, the efficacy and safety of TA in STEMI is unclear., Objective: We sought to evaluate the efficacy and safety of TA during PPCI for STEMI compared with conventional PPCI alone., Methods: We included study-level data from 25 randomized, controlled trials, involving 21,733 patients with STEMI and PPCI. The primary efficacy endpoint was major adverse cardiac events (MACE) according to study definitions; the primary safety endpoint was stroke., Results: The mean weighted follow-up time across studies was 8.2 months. Compared with conventional PPCI, TA was associated with significant lower risk for MACE [relative risk (RR): 0.91; 95% confidence interval (CI): 0.83-1.00; P = 0.042). However, this benefit in MACE was counterbalanced by a significant increase in the risk for stroke (RR: 1.58; 95% CI: 1.11-2.25; P = 0.011). There were no differences in the risk of myocardial infarction (RR: 0.94; 95% CI: 0.78-1.12; P = 0.486), target vessel revascularization (RR: 0.93; 95% CI: 0.82-1.04; P = 0.2), and definite or probable stent thrombosis (RR: 0.84; 95% CI: 0.66-1.07; P = 0.148). TA was associated with an ostensible lower risk for all-cause mortality, which did not reach statistical significance (RR: 0.88; 95% CI: 0.78-1.00; P = 0.059)., Conclusions: Compared with conventional PPCI for STEMI, adjunctive TA reduces the risk of subsequent MACE. However, the benefit in MACE is counterbalanced by an increased risk in stroke. Considering the above potential risks and benefits, TA should be considered in selected patients lesions rather than routinely., (© 2015 Wiley Periodicals, Inc.)

Objectives: This study sought to assess the mechanistic effect of rotational atherectomy (RA) and orbital atherectomy (OA) on heavily calcified coronary lesions and subsequent stent placement using optical coherence tomography (OCT)., Background: RA and OA are two main approaches to ablate coronary calcium. While small case reports have described the mechanistic effect of RA in calcified coronary lesions, there has been no imaging study to assess the effect of OA on coronary artery architecture and/or compare the effects of two atherectomy devices., Methods: This study analyzed 20 consecutive patients with OCT imaging performed after atherectomy and after stent implantation, RA (n = 10) and OA (n = 10)., Results: Postatherectomy OCT analysis identified tissue modification with deep dissections in around a third of lesions after RA and OA; however, post OA dissections ("lacunae") were significantly deeper (1.14 vs. 0.82 mm, P = 0.048). Post OA/RA lesions with dissections had significantly higher percentage of lipid rich plaques and smaller calcification arcs as compared to plaques without dissections. Stents after OA were associated with a significantly lower percent of stent strut malapposition than post RA stents (4.36 vs. 8.02%, P = 0.038)., Conclusions: Although the incidence of dissections was comparable between RA and OA cases, OA resulted in deeper tissue modifications (lacunae) as shown by OCT imaging. The finding might provide an explanation for a better stent apposition after OA as compared to RA. Their impact on long-term outcome needs to be determined., (© 2015 Wiley Periodicals, Inc.)

Objectives: The purpose of this study was to evaluate the 1-year clinical outcomes of more complex XIENCE V USA real-world patients with small versus nonsmall vessel lesions., Background: Patients with small vessel lesions undergoing coronary stent placement are at higher risk of major adverse cardiac events. Improved safety and efficacy of XIENCE V everolimus eluting stents (EES) have been previously demonstrated in selected low-risk small vessel populations in randomized clinical trials., Methods: The XIENCE V USA study was a condition of approval, single-arm study in unselected real-world patients. Baseline and 1-year clinical outcomes were compared between XIENCE V USA patients who received a single 2.5 mm stent (small vessel group, N = 838) and patients implanted with a single >2.5 mm stent (non-small vessel group, N = 2,015). Mean reference vessel diameter was 2.55 ± 0.36 and 3.25 ± 0.46 mm in the small and non-small vessel groups, respectively (P < 0.001)., Results: Small vessel group had more females, presented with a higher rate of diabetes, and had more complex lesion characteristics. The definite or probable ST rates analyzed using Kaplan-Meier method were low and not significantly different between the groups at 0.37 and 0.40% for the small and nonsmall vessel group (P = 0.88), respectively. The composite rate of cardiac death or MI was comparable at 4.5% for the small and 5.1% for the non-small vessel 1 groups (P = 0.57). The 1-year target lesion revascularization rate was also comparable in the small vessel group (3.8% vs. 3.0%, P = 0.35)., Conclusions: Despite gender difference, higher prevalence of diabetes and more complex lesions in the small vessel groups, the 1-year clinical outcomes were similar in both small and nonsmall vessel groups. These results demonstrate the therapeutic benefit of XIENCE V EES in a real-world all inclusive patient population with small vessel disease., (© 2013 Wiley Periodicals, Inc.)

Objectives: To compare the discriminatory value of differing risk scores for predicting clinical outcomes following PCI in routine practice., Background: Various risk scores predict outcomes after PCI. However, these scores consider markedly different factors, from purely anatomical (SYNTAX risk score [SRS]) to purely clinical (ACEF, modified ACEF [ACEFmod], NCDR), while other scores combine both elements (Clinical SYNTAX score [CSS], NY State Risk Score [NYSRS])., Methods: Patients with triple vessel and/or LM disease with 12 month follow-up were studied from a single center PCI registry. Exclusion criteria included STEMI presentation, prior revascularization and shock. Clinical events at 12 months were compared to baseline risk scores, according to score tertiles and area under receiver-operating-characteristic curves (AUC)., Results: We identified 584 eligible patients (69.8±12.3yrs, 405 males). All scores were predictive of mortality, with the SRS being least predictive (AUC=0.66). The most accurate scores for mortality were the CSS and ACEF (AUC=0.76 for both: P = 0.019 and 0.08 vs. SRS, respectively). For TLR, while the SRS trended toward being positively predictive (P = 0.075), several scores trended towards a negative association, which reached significance for the NCDR (P = 0.045). The SRS and CSS were the only scores predictive of MI (both P < 0.05). No score was particularly accurate for predicting MACE (death+MI+TLR), with AUCs ranging from 0.53 (NCDR) to 0.63 (SRS)., Conclusions: Competing factors influence mortality, MI and TLR after PCI. An increasing burden of comorbidities is associated with mortality, whereas anatomical complexity predicts MI. By combining these outcomes to predict MACE, all scores show reduced utility., (Copyright © 2013 Wiley Periodicals, Inc.)

Objectives: To compare the practical use, safety, and clinical outcomes associated with the TandemHeart (TH) versus Impella Recover 2.5 (IR2.5) devices when used for circulatory support during high-risk percutaneous coronary intervention (PCI)., Background: Small studies and registries suggest safety and efficacy for the TH and IR2.5 percutaneous-left ventricular assist devices (P-LVADs). However, these P-LVADs differ markedly in their insertion, operation, and manner of circulatory augmentation. To date, no study has compared these devices., Methods: We identified 68 patients (49 males, 19 females; age 71.1 ± 12.1 years) from our single-center database that underwent "high-risk" PCI with P-LVAD support from April 2005 to June 2010 (32 with TH, 36 with IR2.5). Relevant data were extracted for analysis., Results: Baseline demographics were similar, including low LVEF (overall mean 31.0 ± 13.7%) and elevated STS mortality risk score (4.2 ± 3.7%). Angiographic characteristics were also similar, with a mean of 2.4 ± 1.0 lesions treated per patient, and 29% undergoing left main PCI. PCI success rates were 99% in both groups, with similar in-hospital outcomes and a combined 7% major vascular access site complication rate. A single episode of left atrial perforation occurred during TH use. No patient required emergent CABG and no in-hospital deaths occurred. The 30-day MACE rate (death, myocardial infarction, target lesion revascularization) was 5.8%. There were no differences between the IR2.5 and TH groups with respect to short- or long-term clinical outcomes., Conclusions: The IR2.5 and TH assist devices are safe, equally effective, and associated with acceptable short- and long-term clinical outcomes in patients undergoing "high-risk" PCI., (Copyright © 2013 Wiley Periodicals, Inc.)

Objectives: We evaluated transcatheter aortic valve Implantation (TAVI) in high-risk patients with severe aortic regurgitation (AR) in native or degenerated bioprosthetic valves., Background: TAVI has emerged as a viable treatment modality for severe aortic stenosis in inoperable or high-risk patients. The use of TAVI for treatment of severe AR has remained largely unexplored., Methods: Eight patients (age 79.6 years ± 5.75 years) with severe AR underwent TAVI at six tertiary hospitals between April 2010 and May 2011. All patients were considered to be at prohibitive risk for surgical aortic valve replacement (SAVR).TAVI with the nitinol based Core Valve bioprosthesis (CRS) (Medtronic) was performed in all patients., Results: Transfemoral access was used in all cases. Procedural success was obtained in all cases without any intraprocedural complications. There was no in hospital or 30-day mortality. There were no cases of atrioventricular blocks requiring permanent pacemaker implantation. At a mean follow up of 15.5 ± 15 months; all patients had improvement in New York Heart Association functional class. Follow up echocardiography revealed improved or stable left ventricular ejection fraction and optimal device function in all cases., Conclusions: TAVI with the CRS bioprosthesis is feasible and effective in appropriately selected cases of severe aortic regurgitation in native and bioprosthetic aortic valves., (Copyright © 2012 Wiley Periodicals, Inc.)

Objectives: To investigate if previously reported gender-based outcome disparities following percutaneous coronary intervention (PCI) are applicable in a large and racially-diverse cohort in the drug eluting stent (DES) era., Background: It is generally believed that women suffer inferior outcomes compared to men after PCI. However, various strategies have evolved that may have mitigated this imbalance, including improved medical therapy, attention to risk-factors, and procedural advances of PCI including DES., Methods: We identified 13,752 patients (4,761 female, 34.6%) with complete follow-up data who underwent de novo lesion PCI from 04/2003 to 04/2009. Relevant data were extracted from an IRB-approved registry., Results: Compared to males, females were significantly older (69.0 vs. 64.8 years) and more frequently from a minority or non-Caucasian background. Females smoked less, but more were hypertensive and/or diabetic. Women had higher HDL, but also higher LDL cholesterol levels. More women presented with an unstable coronary syndrome and required left anterior descending artery PCI. While unadjusted post-PCI mortality rates were higher in females versus males (30 days, 1.3 vs. 0.8%, P = 0.009; 1 year, 6.1 vs. 4.8%, P = 0.001; 3 year, 10.4 vs. 8.4%, P < 0.0001), multivariable regression analyses failed to identify female gender as an independent predictor of mortality. Propensity-adjusted modeling confirmed that females were not at intrinsically higher risk for mortality after PCI., Conclusions: Females undergoing PCI exhibit more comorbidities and adverse prognostic factors than males. However, risk-adjusted analyses identified that gender is not an independent predictor of mortality after PCI in the DES era., (Copyright © 2011 Wiley Periodicals, Inc.)

Despite surgical advances, the Bentall procedure still carries a 2-6% rate of acute complications involving the coronary vessels, including ostial stenoses, kinking or pseudoaneurysm formation. We report an unusual case of a patient who developed acute cardiogenic shock within hours following a Bentall procedure, requiring urgent mechanical assist device support. Coronary angiography revealed significant bilateral coronary ostial stenoses; suggesting global cardiac hypoperfusion as the cause for this acute hemodynamic collapse. Given the disturbed coronary anatomy, the novel Szabo technique was used to accurately position and deploy an ostial right and then an ostial left main coronary stent, with excellent angiographic results. We conclude that even in situations with altered coronary anatomy, the Szabo technique should be considered for any patient requiring precise aorto-ostial stent placement., (Copyright © 2011 Wiley-Liss, Inc.)

Objectives: We seek to identify predictors of 30-day mortality after balloon aortic valvuloplasty (BAV)., Background: To date, there is no validated method of predicting patient outcomes after percutaneous aortic valve interventions., Methods: Data for consecutive patients with severe aortic stenosis who underwent BAV at the Mount Sinai Medical Center from January 2001 to July 2007 were retrospectively reviewed. Cox-proportional hazards regression was used to identify significant predictors of 30-day mortality, and the resultant model was compared to the EuroSCORE using Akaike's Information Criterion and area under the receiver-operating curve (AUC)., Results: The analysis included 281 patients (age 83 ± 9 years, 61% women, aortic valve area: 0.64 ± 0.2 cm(2)) and 36 (12.8%) of whom died within 30 days of BAV. With identified risk factors for 30-day mortality, critical status, renal dysfunction, right atrial pressure, and cardiac output, we constructed the CRRAC the AV risk score. Thirty-day survival was 72% in the highest tertile versus 94% in the lower two tertiles of the score. Compared to the additive and logistic EuroSCORE, the risk score demonstrated superior discrimination (AUC = 0.75 vs. 0.60 and 0.63, respectively)., Conclusions: We derived a risk score, the CRRAC the AV score that identifies patients at high-risk of 30-day mortality after BAV. Validation of the developed risk prediction score, the CRRAC the AV score, is needed in other cohorts of post-BAV patients and potentially in patients undergoing other catheter-based valve interventions., (Copyright © 2010 Wiley-Liss, Inc.)

The use of percutaneous coronary intervention (PCI) in the treatment of obstructive coronary artery disease has expanded rapidly in the past decade. Despite the extensive technological advancements in the field, pharmacotherapy has remained a cornerstone in the overall treatment strategy. Oral antiplatelet therapy has become an essential component of therapy with acute coronary syndromes and in PCI by improving clinical outcomes. This article reviews the antiplatelet options for patients undergoing PCI, including aspirin, ADP receptor blockers, and glycoprotein IIb/IIIa inhibitors., ((c) 2010 Wiley-Liss, Inc.)

A panel of leaders in the field of interventional cardiology convened to discuss the evidence-based management of patients undergoing percutaneous coronary intervention (PCI). The articles in this supplement are based on individual presentations given during the panel meeting. Following are key points of the panel's discussion and areas that the panel has indicated warrant further study., ((c) 2010 Wiley-Liss, Inc.)

Objectives: The objective of this study is to analyze the clinical outcomes and treatment strategies of coronary wire perforations (WPs) in the era of heparin use compared to the era of bivalirudin use., Background: Percutaneous coronary intervention (PCI) advances have led to progressive decrease in complications. Therefore, complex coronary lesions such as chronic total occlusions and calcified lesions are being attempted with stiff/hydrophilic wires with resultant higher incidence of coronary WP., Methods: A single-center retrospective data analysis of coronary perforation (CP) for the last 4 years with review of coronary angiograms was done and WPs were identified. A simple classification scheme based on angiographic appearance of CP was made: Type I ("myocardial stain," with no frank dye extravasation) and type II ("myocardial fan," with dye extravasation to pericardial cavity or cardiac chambers)., Results: Overall incidence of CP was 0.49% (82/16,859). Of these 50 (61%) were caused by WP; 30 occurred with heparin use (Group A) and 20 with bivalirudin use (Group B). WPs always occurred in type B2/C lesions (100%) and commonly with use of hydrophilic guidewires (70%). Major adverse cardiac events and cardiac tamponade were frequent in group A (50%) and none in group B (0%); P < 0.01. All WP in group B responded to stopping anticoagulation and prolonged balloon inflation, while group A type II perforations frequently required additional interventions (pericardiocentesis, coil embolization)., Conclusions: Cardiac tamponade and major adverse cardiac events from WPs were less frequent with bivalirudin use compared to heparin use. This beneficial effect of bivalirudin may be explained on the basis of its short half-life and reversible thrombin inhibition property. Therefore, bivalirudin may offer a safer alternative for anticoagulation in complex PCI., (Copyright 2009 Wiley-Liss, Inc.)

Unlabelled: The occurrence of contrast induced nephropathy (CIN) is associated with increased mortality after percutaneous revascularization procedures. However, the exact correlation between various levels of creatinine elevation relative to the baseline and subsequent mortality in patients with chronic renal insufficiency (CRI) is not well established. In addition, the relationship between elevated postprocedural creatinine and ensuing mortality in patients with normal baseline renal function needs to be investigated., Methods: All percutaneous coronary intervention (PCI) patients (n = 12,997) were analyzed for any rise in serum creatinine (SCr): CRI group (BSC > or = 1.5 mg/dl) (n = 1,853) and normal baseline renal function (NBR BSC < 1.5 mg/dl) group (n = 11,144). Patients in each group were analyzed for any elevation in SCr postprocedure and subdivided based on the SCr ratio [peak SCr/Baseline creatinine (BSC)] of <1.25, 1.25-1.5, and >1.5. The overall incidence of CIN (defined as an increment of 25% over baseline creatinine) was 5.9%: 11.3% in the CRI group versus 5.1% in normal BSC group (P < 0.01). Recursive partitioning and Cox hazard modeling were used to assess significant variables associated with mortality within 1 year. Only serum creatinine ratio (SCrR) > 1.5 correlated with increased mortality in both CRI group as well as normal BSC group., Conclusions: SCrR > 1.5 predicts mortality at 1 year after PCI. The association between SCrR > 1.5 and increased mortality at follow-up is observed in patients with CRI as well as normal baseline renal function. SCrR may thus serve as a useful clinical tool for risk stratification and prognostication of patients after PCI., (Copyright 2009 Wiley-Liss, Inc.)

Objectives: The aim of the present study was to study the outcome of coronary stenting in patients with symptomatic myocardial bridging refractory to standard medical therapy., Background: Medical therapy constitutes the first line treatment for patients with symptomatic myocardial bridge, surgical correction may be offered to select patients with refractory symptoms. Limited data exists on the outcome of coronary stenting in this patient cohort., Methods: Twenty-nine patients with symptoms of angina, documented myocardial ischemia and angiographically documented myocardial bridge of the left anterior descending artery (defined as [mt]50% systolic compression) were identified retrospectively. Seventeen (59%) patients responded to maximized medical therapy (mean age 51 +/- 16 years, range 29-80, 7 female) and 12 (41%) patients received coronary stents following a failed attempt of minimum 3 months of maximal medical therapy (mean age 49 +/- 15 years, range 32-76 years, 5 females). Medical therapy responders were compared with intracoronary stent group for recurrent severe angina, target vessel revascularization (TVR), myocardial infarction (MI), and death at follow-up., Results: Intracoronary stents were placed in all patients successfully. The incidence of recurrent severe angina and TVR were significantly greater in the stent group (P = 0.04) while MI and death in two groups were similar at mean follow-up of 15 +/- 3 months., Conclusions: Coronary stent placement for medically refractory symptomatic myocardial bridge failed to relieve severe angina and is associated with high clinical restenosis and hence should be avoided., (Copyright 2008 Wiley-Liss, Inc.)

Contrast-induced nephropathy (CIN) is associated with high morbidity and mortality. The recent literature contains numerous clinical trials with similar design, endpoints, and patient populations, describing the nephrotoxic effects of various contrast agents, which are higher with ionic vs. nonionic contrast agents. The difference in the incidence of CIN with nonionic contrast agents may be due to the number of benzene rings (monomer vs. dimer), iodine content, osmolality, and viscosity of the individual contrast agents. We evaluated the recently published data from clinical studies with nonionic iodinated contrast agents in patients with preexisting chronic renal insufficiency (CRI) and report the results of pooled analysis of data from recent prospective independent studies of CIN with various nonionic contrast agents. Review of the recent literature revealed that the CIN incidence varies across the studies reviewed and the contrast agents used. The highest incidence of CIN was observed in studies using iohexol or ioxilan. Results of the pooled analysis of nonionic contrast agents (with more than one randomized study) showed a similar incidence of CIN after iodixanol and iopamidol in patients with preexisting CRI, while both agents showed a significantly lower incidence of CIN compared to iohexol. Since iodixanol is more expensive than iopamidol, this observation may be clinically relevant.

Treatment of bifurcation lesions is associated with high procedural complications and restenosis rate due to plaque shift, suboptimal angiographic results, difficulty in crossing the stent struts, and incomplete coverage of the side-branch ostium. The simultaneous kissing stent (SKS) technique involves two stents, one in main vessel (MV) and one in the side branch (SB) with overlapping stents in the MV proximally, extending proximally the carina of bifurcation. We analyzed our first 200 consecutive patients (202 lesions) who underwent SKS technique for true bifurcation lesions using sirolimus eluting stents, with a minimum follow-up of 6 months. Procedural success was 100% for MV and 99% for SB using SKS technique, with clinical success rate of 97%. In-hospital and 30-day major adverse cardiac events were 3% and 5%, respectively, with a procedure time of 36 +/- 14 min. At mean follow-up of 9 +/- 2 months, the incidence of target lesion revascularization was 4% in the entire group. Therefore, SKS technique using sirolimus-eluting stents may become an effective treatment strategy for large-size bifurcation lesions. However, in order to establish its superiority, SKS technique needs to be compared in a randomized manner with conventional stent techniques., ((c) 2005 Wiley-Liss, Inc.)

Despite the increasing use of percutaneous transluminal coronary angioplasty and intracoronary stent placement for the treatment of obstructive coronary artery disease, a large subset of coronary lesions cannot be adequately treated with balloon angioplasty and/or intracoronary stenting alone. Such lesions are often heavily calcified or fibrotic and undilatable with the present balloon technology and attempts to treat them with balloon angioplasty or intracoronary stent placement often lead to vessel dissection or incomplete stent deployment with resultant adverse outcomes. Rotational atherectomy remains a useful niche device for the percutaneous treatment of such complex lesions, usually as an adjunct to subsequent balloon angioplasty and/or intracoronary stent placement. In contrast to balloon angioplasty or stent placement that widen the coronary lumen by displacing atherosclerotic plaque, rotational atherectomy removes plaque by ablating the atherosclerotic material, which is dispersed into the distal coronary circulation. Other lesion subtypes amenable to treatment with this modality include ostial and branch-ostial lesions, chronic total occlusions, and in-stent restenosis. This review discusses the technique and principles of rotational atherectomy, the various treatment strategies for its use (including adjunctive pharmacotherapy), the lesion-specific applications for this device, and the complications unique to this modality. Recommendations are also made for its use in the current interventional era., (Copyright 2004 Wiley-Liss, Inc.)

Radiographic contrast nephropathy (RCN), acute worsening of renal function due to contrast agents, can occur in 15%-40% of patients with baseline renal dysfunction undergoing percutaneous coronary intervention (PCI) and is associated with increased morbidity and in-hospital mortality. The purpose of this study was to evaluate whether the selective dopamine-1 (DA-1) receptor agonist fenoldopam would be beneficial in patients with chronic renal insufficiency (CRI) undergoing PCI and also to design a protocol for prevention of RCN. We analyzed 150 consecutive patients with CRI [baseline serum creatinine (BSCr) +/- 1.5% mg] who underwent PCI and received fenoldopam during and after the procedure, in addition to saline hydration. RCN, defined as > 25% increase of BSCr 48-72 hr after PCI, occurred in 4.7% (n = 7) of 150 PCI patients receiving fenoldopam and 3.5% in diabetics (n = 85) vs. 6.1% in nondiabetics (n = 65; P = NS). No patients required dialysis. The observed 4.7% incidence of RCN with fenoldopam was significantly lower than 18.8% incidence in the historical control group (P < 0.001). Our data suggest that fenoldopam is a useful adjunct in the prevention of RCN during PCI, especially in diabetics., (Copyright 2002 Wiley-Liss, Inc.)