The impact of successful revascularization of coronary chronic total occlusions on long‐term clinical outcomes in patients with non‐ST‐segment elevation myocardial infarction

Objectives

The purpose of this study was to assess the long‐term clinical impact of revascularization of coronary concomitant coronary chronic total occlusion (CTO) in patients with Non‐ST‐segment elevation myocardial infarction (NSTEMI).

Background

CTO is associated with poorer prognosis in patients with NSTEMI. The evidence of revascularization of CTO in patients with NSTEMI is still conflicting.

Methods

Consecutive patients with NSTEMI and CTO who underwent percutaneous coronary intervention (PCI) within 72 h of admission from 2006 to 2015 were retrospectively recruited and analyzed. A total of 967 patients underwent PCI for NSTEMI. Among them, 106 (11%) patients had concomitant CTO and were recruited for analysis. CTO lesions were revascularized successfully in 67 (63.2%) patients (successful CTO PCI group), while the CTO in the remaining 39 patients were either not attempted or failed (No/failed CTO PCI group).

Results

The 30‐day cardiac death and major adverse cardiac events (MACE) were significantly lower in the successful CTO PCI group (both cardiac death and MACE were 3% vs 30%, P < 0.001, respectively). A landmark analysis set at 30th day for 30‐day survivals was performed. After a mean of 2.5‐year follow‐up, the long‐term cardiac death was still significantly lower (16.9% vs 42.3%, P < 0.001), whereas the MACE showed a trend toward lower incidence (26.2% vs 40.7%, P = 0.051) in the successful CTO PCI group. In multivariate Cox regression analysis, successful revascularization of CTO is an independent protective predictor for long‐term cardiac death (HR 0.310, 95% CI, 0.109‐0.881, P = 0.028) in all population and in propensity‐score matched cohort (P = 0.007).

Conclusions

Successful revascularization of CTO was associated with reduced risk of long‐term cardiac death in patients with NSTEMI and concomitant CTO.

     

Variability in Maximal Suggested Door‐in‐Door‐out Time for Hospitals Transferring Patients for Primary Angioplasty in STEMI

Objectives

We derived a formula for maximal suggested door‐in‐door‐out time (DIDO) for hospitals that do not perform primary percutaneous coronary intervention (PCI) for ST‐elevation myocardial infarction (STEMI).

Background

Efforts to minimize DIDO at non‐PCI hospitals can improve door‐to‐balloon time (D2B). Targeting a maximal suggested DIDO for a transferring hospital can influence reperfusion strategy.

Methods

We examined time to treatment intervals for 193 STEMI patients who underwent primary PCI at our hospital. D2B in transferred patients (D2B_T) was divided into 3 intervals: transferring hospital DIDO, inter‐hospital transport time, and interventional time. We defined maximal suggested DIDO as the maximum DIDO that would allow PCI with D2B_T ≤120 minutes.

Results

D2B was higher in transfer compared to on‐site patients (147 ± 52 vs. 75 ± 44 minutes, P < 0.0001). In transfer patients, treatment time intervals were: DIDO 80 ± 42 minutes, transport time 37 ± 18 minutes, interventional time 35 ± 16 minutes. The greatest variability in D2B_T was related to DIDO. We estimated that maximal suggested DIDO = [120 ? (transport time plus interventional time)]. Using a fixed interventional time of 40 minutes, we simplified this as: maximal DIDO = 80 ? transport time. Maximal suggested DIDO for 4 transferring hospitals in our network ranged from 1 to 65 minutes. DIDO under the hospital‐specific threshold was the strongest predictor of achieving D2B_T <120 minutes.

Conclusions

Transferring hospitals' maximal suggested DIDO is variable, and can be calculated from inter‐hospital transport time. Instead of a universal target DIDO (e.g., <30 minutes), maximal suggested DIDO can be calculated individually for each non‐PCI hospital within a STEMI network.

     

Factors Associated With Ineligibility for PCI Differ Between Inpatient and Outpatient ST‐Elevation Myocardial Infarction

Objectives

Without early revascularization, both inpatient and outpatient STEMIs have poor outcomes. Reasons for denying PCI for STEMI, however, remain uncertain. This single‐center retrospective cohort study compares factors and outcomes associated with ineligibility for PCI between inpatients and outpatients following ST‐elevation myocardial infarction (STEMI).

Methods

A total of 1,759 STEMI patients between June 2009 and January 2015 were assessed. Individual medical records were reviewed to obtain reasons for PCI ineligibility for STEMI patients who did not receive reperfusion therapy.

Results

Compared to outpatients with STEMI (n = 1,688), inpatients (n = 71) were less likely to receive coronary angiography (60.6% vs 95.9%; P < 0.001) or PCI (50.7% vs 80.9%; P < 0.001), with longer ECG/door to first device activation times (97 [78, 131] vs 63 [49, 78] minutes; P < 0.001). When coronary angiography was performed, however, similar rates of PCI and procedural success were seen in both groups. Principal contraindication for PCI was risk of bleeding within the inpatient population and complex coronary artery disease within the outpatient population. Total in‐hospital mortality was higher in inpatient STEMIs compared to outpatients (42.2% vs 10.0%; P < 0.001), but lower for patients eligible for PCI in both groups.

Conclusions

Reasons for PCI ineligibility differ between inpatient and outpatient STEMIs. Inpatients have increased risks of bleeding, lower coronary angiography and PCI use, and higher in‐hospital mortality. Especially for inpatients, specific PCI STEMI protocols that anticipate and overcome types of ineligibility and delay for cardiac catheterization may improve outcomes.

     

Short‐ and Long‐Term Prognostic Value of the TIMI Risk Score after Primary Percutaneous Coronary Intervention for ST‐segment Elevation Myocardial Infarction

Objectives

We investigated the short‐ and long‐term predictive value of the TIMI risk score regarding mortality for patients treated with primary percutaneous coronary intervention (PPCI) for ST‐elevation myocardial infarction (STEMI).

Background

Data on the long‐term predictive value of the TIMI risk score is sparse.

Methods

We used data from 3,609 STEMI patients undergoing PPCI in a high‐volume PCI center in The Netherlands. Cumulative event rates according to TIMI score variables were estimated with the Kaplan‐Meier method and compared with the log‐rank test. The original TIMI risk score was modified based on the availability of the data in the single center registry.

Results

Higher TIMI scores were associated with significantly higher mortality at short‐ and long‐term follow‐up (P < 0.001 for both). Age and Killip Class IV at presentation were significant predictors for both short‐ and long‐term mortality. Patients with an anterior MI, heart frequence >100 beats per minute, or systolic blood pressure <100 mmHG had a worse short‐term prognosis compared to those who had not. However, long‐term mortality was nonsignificantly different. The presence of a history of diabetes/hypertension and weight had only long‐term prognostic value. Time to PPCI did not have any prognostic value.

Conclusions

Our current report shows that the TIMI risk score has both short‐ and long‐term discriminative value. The different variables contained in the TIMI risk score predict short‐term prognosis, others predominantly long‐term mortality, whereas some are predictive for both. (J Interven Cardiol 2013;26:8–13)

     

Thrombus aspiration in late presenters with ST‐elevation myocardial infarction: A single‐center randomized trial

Objectives

To examine whether routine thrombus aspiration (TA) is associated with improved myocardial salvage in patients with ST‐elevation myocardial infarction (STEMI) presenting ≥12 h after onset of symptoms.

Background

TA is a recognized treatment option in patients with STEMI undergoing primary percutaneous coronary intervention (PPCI) especially in the setting of heavy thrombus burden. However, data on the role of TA in STEMI patients presenting late after onset of symptoms are limited.

Methods

In this single‐center prospective randomized study, patients with subacute STEMI presenting ≥12 and ≤48 h after symptom onset were randomized to primary PCI with or without manual TA in a 1:1 ratio. The primary endpoint was the myocardial salvage index assessed with Single Photon Emission Computed Tomography (SPECT) on admission and 4 days later.

Results

A total of 60 patients underwent randomization. Baseline characteristics were comparable between groups. TA was associated with improved myocardial salvage index compared with control group (60.1 ± 11.1% vs 28.1 ± 21.3%; P = <0.001). Furthermore, TA was associated with improved post‐procedural TIMI flow (2.9 ± 0.3 vs 2.5 ± 0.6; P = 0.003), myocardial blush grade (2.9 ± 0.3 vs 2.2 ± 0.8, P = <0.001), and reduction in left ventricular end‐diastolic dimensions (50.4 ± 4.3 mm vs 54.4 ± 5.8 mm, P = 0.004) compared with the control group. Clinical outcomes at 30 days and 6 months were similar between both groups.

Conclusions

TA might be associated with improved reperfusion and myocardial salvage especially in STEMI patients presenting after 12 h from symptom onset who are likely to have a heavy thrombus burden.

     

Comparison of transcatheter aortic valve replacement risk score against currently accepted surgical risk models as predictors of 30‐day mortality in transcatheter aortic valve replacement

Objectives

Aim of the study was to assess the predictive capability of Transcatheter Aortic Valve Replacement Risk Score (TAVR‐RS) in comparison with Society of Thoracic Surgeon‐Predicted Risk of Mortality (STS PROM) and European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) on 30‐day mortality following TAVR.

Background

With exponentially increasing use of TAVR, a risk stratification model to accurately predict mortality risks in patients undergoing TAVR is urgently warranted.

Methods

Retrospective analysis of 182 TAVRs between 2014 and 2017, 179 by transfemoral, 3 by subclavian approach. Clinical, laboratory and echocardiography variables were collected. The performance of risk models was evaluated using equivalence tests, receiver operating characteristic (ROC) and area under the ROC curve (AUC). Outcome was 30‐day mortality prediction.

Results

Observed 30‐day mortality was 5.49%. TAVR‐RS underestimated (4.0%) while surgical models (STS PROM and EuroSCORE II) overestimated mortality, 7.24% and 8.14%, respectively. The TAVR‐RS was found to have statistically significant correlation with both individual and group mortalities. AUC was highest for TAVR‐RS 0.66 (95%CI: 0.31–0.96), but no difference in 30‐day mortality prediction was found in comparison with STS PROM (P = 0.06) or EuroSCORE II (P = 0.2161).

Conclusions

The TAVR‐RS was a better predictor of both group and individual mortality at 30 days. The outcomes were comparable on pairwise testing against surgical risk models, although TAVR‐RS was on verge of significance when compared to STS PROM. This study supports the current dogma that a risk model specifically tailored for TAVR population should be implemented to obtain a better patient selection.

     

Women With Cardiogenic Shock Derive Greater Benefit From Early Mechanical Circulatory Support: An Update From the cVAD Registry

Objectives

The aim of this analysis was to assess survival differences between men and women supported with Impella 2.5 (Abiomed Inc., Danvers) in the setting of acute myocardial infarction (AMI) complicated by cardiogenic shock (CS).

Background

Data on sex differences in outcomes of CS with mechanical circulatory support are sparse.

Methods

Patients enrolled in the cVAD Registry who underwent percutaneous coronary intervention (PCI) and Impella 2.5 support for CS complicating an AMI were included. Differences between men and women were examined.

Results

In total, 180 patients were analyzed. Women (n = 49, 27.2%) were older (71.0 ± 12.8 years vs 63.8 ± 13.0, P = 0.001), smaller (BSA 1.82 ± 0.22 vs 2.04 ± 0.24 m², P < 0.001), and had a higher STS mortality risk score than men (27.9 ± 17.0 vs. 20.8 ± 16.8 P = 0.01). There was no difference in survival to discharge (P = 0.3). Patients receiving the Impella 2.5 pre‐PCI had significantly lower inpatient mortality than those who received support post‐PCI (P = 0.003). However, the magnitude of the survival benefit was significantly greater in women who received the Impella pre‐PCI as compared to men. Overall, 68.8% of women survived with pre‐PCI Impella 2.5 versus 24.2% post‐PCI (P = 0.005) whereas 54.2% of men survived with pre‐PCI Impella 2.5 versus 40.3% post‐PCI (P = 0.1, p‐interaction = 0.07). No differences in timing to intervention were found between men and women.

Conclusions

Early initiation of hemodynamic support prior to PCI with Impella 2.5, in the setting of AMI complicated by CS, was associated with a greater survival benefit to hospital discharge in women compared to men, despite a higher predicted risk of mortality and a greater revascularization failure rate for women. (J Interven Cardiol 2016;29:248–256)

     

Low On‐Treatment Platelet Reactivity Predicts Long‐Term Risk of Bleeding After Elective PCI

Background

Bleeding after percutaneous coronary interventions (PCI) is an important complication with impact on prognosis.

Aim

To evaluate the predictive value of enhanced platelet responsiveness to dual antiplatelet therapy with aspirin and clopidogrel, for bleeding, after elective PCI.

Methods and Results

We performed multiple electrode aggregometry (MAE) platelet functional tests induced by arachidonic acid (ASPI) and adenosine‐diphosphate (ADP) before PCI, and 24 hours after PCI, in 481 elective PCI patients who were followed‐up for an average of 15.34 ± 7.19 months. Primary end point was the occurrence of any bleeding, while ischemic major adverse cardiovascular event (MACE) was a secondary endpoint. The incidence of total, BARC ≤ 2, and BARC ≥ 3 bleeding, according to BARC classification, was 19, 18, and 1%, respectively. Groups with any, and BARC ≤ 2 bleeding, had a lower average value of MAE ADP test after 24 hours, compared to the group without bleeding: 45.30 ± 18.63 U versus 50.99 ± 19.01 U; P = 0.005; and 45.75 ± 18.96 U versus 50.99 ± 18.99 U; P = 0.01; respectively. Female gender (HR 2.11; CI 1.37–3.25; P = 0.001), previous myocardial infarction (HR 0.56; CI 0.37–0.85; P = 0.006), lower body mass (HR 0.78; CI 0.62–0.98; P = 0.03), and MAE ADP test after 24 hours (HR 0.75; CI 0.61–0.93; P = 0.009) were the independent predictors for any bleeding by Cox univariate analysis. After adjustment, MAE ADP test after 24 hours, was the only independent predictor for any (HR 0.7; CI 0.56–0.87; P = 0.002), and BARC ≤ 2 (HR 0.71; CI 0.56–0.89; P = 0.003) bleeding, by Cox multivariate analysis.

Conclusion

MAE ADP test before and after PCI, was associated with any, and BARC ≤ 2 bleeding after elective PCI.

     

Impella 2.5 initiated prior to unprotected left main PCI in acute myocardial infarction complicated by cardiogenic shock improves early survival

Objectives

To assess post‐procedural outcomes when Impella 2.5 percutaneous left ventricular assist device (pLVAD) support is initiated either prior to or after percutaneous coronary intervention (PCI) on unprotected left main coronary artery (ULMCA) culprit lesion in the context of acute myocardial infarction cardiogenic shock (AMICS).

Background

Initiation of Impella 2.5 pLVAD prior to PCI is associated with significant survival benefit in the setting of AMICS. Outcomes of those presenting with a ULMCA culprit lesion in this setting have not been well characterized.

Methods

Thirty‐six consecutive patients in the cVAD Registry supported with Impella 2.5 pLVAD for AMICS who underwent PCI on ULMCA culprit lesion were included in our multicenter study.

Results

The average age was 69.8 ± 14.2 years, 77.8% were male, 72.7% were in CS at admission, 44.4% sustained one or multiple cardiac arrests, and 30.6% had anoxic brain injury. Baseline characteristics were comparable between the Pre‐PCI group (n = 20) and Post‐PCI group (n = 16). Non‐ST segment elevation myocardial infarction and greater coronary disease burden were significantly more frequent in the Pre‐PCI group but they had significantly better survival to discharge (55.0% vs 18.8%, P = 0.041). Kaplan‐Meier 30‐day survival analysis showed very poor survival in Post‐PCI group (48.1% vs 12.5%, Log‐Rank P = 0.004).

Conclusions

Initiation of Impella 2.5 pLVAD prior to as compared with after PCI of ULMCA for AMICS culprit lesion is associated with significant early survival. As previously described, patients supported after PCI appear to have very poor survival at 30 days.

     

Age is not a bar to PCI: Insights from the long‐term outcomes from off‐site PCI in a real‐world setting

Objectives

We sought to analyze the percutaneous coronary intervention (PCI) outcomes of very elderly patients (V. Eld. group, age >80 years) and compare their outcomes to a less elderly cohort (Eld. group, age 75‐80 years) traditionally reported in the literature.

Background

Limited data exist on peri‐procedural and long‐term outcomes following PCI in the V. Eld. (age >80 years), with under‐representation of this cohort in randomized controlled trials. These patients present with advanced complex coronary disease and multiple comorbidities.

Methods

All 580 consecutive patients aged ≥75 years (age 80 ± 4.9 years, 57.4% males) undergoing PCI between April 2006 and November 2011 were included. A total of 624 consecutive lesions were identified and analyzed. All V. Eld. patients (n = 253) were subsequently selected, and their outcomes compared to Eld. patients (n = 327). Mean follow‐up was 30.8 ± 2.7 months with 98% clinical follow‐up achieved.

Results

All comparative data are expressed as (V. Eld. vs Eld.) unless otherwise specified. All‐cause mortality was significantly higher in the V. Eld. group (11.9% vs 6.1%), although this did not translate into a significant difference in cardiac mortality (6.3% vs 3.7%) or major adverse cardiac and cerebrovascular events (16.2% vs 12.5%). The composite incidence of myocardial infarction (MI), stroke, definite/probable stent thrombosis, and TIMI major bleed was 4.7%, 1.4% 1.9%, and 6.4%, respectively with no significant difference between both cohorts.

Conclusions

This study demonstrates an acceptable occurrence of MI, death, repeat intervention, and stent thrombosis in a high‐risk group of V. Eld. patients with de novo lesions. Age alone in the absence of other non‐cardiac factors should not prohibit a patient from access to PCI.

     

Post‐Procedural Bivalirudin Infusion Following Primary PCI to Reduce Stent Thrombosis

Background

Prolonging infusions may abrogate the acute stent thrombosis (ST) associated with bivalirudin use during primary PCI but at an increased cost. We hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose until infusion end would prevent excess early ST.

Methods

Baseline demographics, procedural data and outcomes were gathered prospectively on 1395 consecutive patients undergoing primary PCI. The choice of bivalirudin versus heparin was at the cardiologist's discretion. Local protocol recommended continuation of the procedural bivalirudin at the PCI dose until infusion end.

Results

Patients' mean age was 62.8 ± 13.1years with 11.4% presenting with shock. The majority of patients underwent PCI using bivalirudin with fewer using heparin (87.7 vs. 12.3%, P < 0.0001). Glycoprotein inhibitor bailout rates were 6.1% with bivalirudin and 36.3% with heparin (P < 0.0001). Calculated on an individual patient basis the median intra‐procedure duration of the bivalirudin infusion was 30(IQR 21‐43) minutes and post‐procedure 49(32–66) minutes. The acute (<24‐hours) ST rates were 4/1224 with bivalirudin ± GPI (0.3%) and 0/171 with heparin ± GPI (0%, P = 0.41). The sub‐acute (24‐hours to 30‐days) ST rates were 3/1224 for bivalirudin ± GPI (0.3%) and 2/171 with heparin ± GPI (1.2%, P = 0.11). In total the early (<30‐days) ST rates were 7/1224 for bivalirudin ± GPI (0.6%) and 2/171 with heparin ± GPI (1.2%, P = 0.31). Acute ST was significantly more likely to occur in clopidogrel‐loaded patients than prasugrel/ticagrelor patients (2.7 vs. 0.5%, P = 0.003).

Conclusion

Continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose until infusion end combined with potent P₂Y12 inhibitors ameliorates excess early stent thrombosis. (J Interven Cardiol 2016;29:129–136)

     

The Index of Microcirculatory Resistance Postpercutaneous Coronary Intervention Predicts Left Ventricular Recovery in Patients With Thrombolyzed ST‐Segment Elevation Myocardial Infarction

Background

The index of microcirculatory resistance (IMR), an invasive measure of microvascular function, has been shown to correlate with clinical outcomes in patients with ST‐segment elevation myocardial infarction (STEMI). The aim of this study is to evaluate the predictive value of IMR on left ventricular recovery in patients undergoing a pharmacoinvasive strategy for STEMI.

Methods

The index of microcirculatory resistance was assessed following percutaneous coronary intervention (PCI) in 31 patients with STEMI who were initially managed with thrombolysis. Other markers of microvascular function such as coronary flow reserve (CFR), TIMI flow grade, corrected TIMI frame count (cTFC), and ST‐segment resolution were also recorded. All indices were evaluated against measures of left ventricular function and recovery 3 months postindex event.

Results

The IMR correlated with left ventricular function, as assessed by wall motion score and ejection fraction at 3‐month follow‐up (r = 0.652, P = 0.005; r = ?0.452, P = 0.011, respectively). The traditional methods of assessing microvascular function, such as CFR, TIMI flow grade, cTFC, and ST‐segment resolution did not correlate with wall motion score and ejection fraction at 3 months. Post‐PCI IMR was significantly lower in those patients with left ventricular recovery at 3 months (18 U vs 39 U, P < 0.001). The optimal cut‐off value for post‐PCI IMR and left ventricular recovery was 32 U. In patients in whom the IMR was greater than 32 U, the percent change in ejection fraction was significantly lower than in those patients in whom the IMR was less than 32 U (2 ± 11 vs 12 ± 8, P = 0.012).

Conclusions

In patients presenting with STEMI initially managed with thrombolysis and subsequently undergoing PCI, IMR correlates with measures of left ventricular function and has the potential to predict left ventricular recovery at 3 months. (J Interven Cardiol 2016;29:146–154)

     

Collagen Plug Vascular Closure Devices and Reduced Risk of Bleeding with Bivalirudin Versus Heparin Plus Abciximab in Patients Undergoing Percutaneous Coronary Intervention for Non ST‐Segment Elevation Myocardial Infarction

Introduction

In ISAR‐REACT‐4 (abciximab and heparin vs. bivalirudin for non‐ST‐elevation myocardial infarction [NSTEMI]), bivalirudin reduced the risk of bleeding after percutaneous coronary intervention (PCI) compared with unfractionated heparin plus abciximab (UFH + abciximab). Vascular closure devices (VCDs) may also prevent bleeding complications, and thus attenuate the benefit of bivalirudin. This analysis examined whether there exists an interaction on bleeding between VCDs and bivalirudin versus UFH + abciximab after PCI.

Methods

Patients with NSTEMI were randomly assigned to either receive UFH + abciximab or bivalirudin for PCI. The use of a VCD after femoral access was left to the operator's discretion. The effect of randomized treatment in patients who received a VCD was compared to that in patients with manual compression of the femoral access site. The primary end‐point of this analysis was the 30‐day incidence of ISAR‐REACT‐4 major bleeding.

Results

A total of 1,711 patients were enrolled in this analysis. Among the 365 (21.3%) patients receiving a VCD, 188 (51.5%) were treated with UFH + abciximab and 177 (48.5%) with bivalirudin. ISAR‐ REACT‐4 major bleeding was higher with UFH + abciximab than with bivalirudin, independent of whether a VCD was used (4.8% vs. 2.3% with VCD and 4.6% vs. 2.7% without VCD, Pint = 0.76). There were also no interactions between randomized treatment and VCDs with respect to any of the ischemic end‐points or net clinical outcome (Pint > 0.56).

Conclusions

In patients undergoing PCI for NSTEMI, the reduction of major bleeding by bivalirudin compared with UFH + abciximab was not affected whether a VCD was used.

     

Application of the “Hybrid Approach” to Chronic Total Occlusion Interventions: A Detailed Procedural Analysis

Objective

To assess the outcomes of the “hybrid” approach to chronic total occlusion (CTO) percutaneous coronary interventions (PCIs).

Background

The “hybrid approach” to CTO PCI advocates appropriate and early change of crossing strategy to maximize success, safety, and efficiency.

Methods

We prospectively recorded and analyzed detailed step‐by‐step procedural data in 73 consecutive CTO PCI cases performed by a single operator between July 2011 and August 2012.

Results

Technical success was achieved in 66 of 73 cases (90.4%). Mean patient age was 65 ± 7 years, and 30% had prior coronary artery bypass surgery. Dual injection was used in 78%. The primary approach was retrograde in 9 cases (12.5%) and antegrade in 64 cases (87.5%), of whom 25 cases (39.1%) underwent retrograde attempt after failed antegrade approach. The initial crossing approach was successful in 40 cases (54.8%), but 32 cases (44%) required 3.6 ± 1.4 approach changes (range 2–7). Antegrade wire escalation, antegrade dissection/reentry, and retrograde crossing were utilized in 97.2%, 46.6%, and 46.6% of cases, respectively. Among successful cases, the final CTO crossing technique was antegrade wire escalation in 50.0%, antegrade dissection/reentry in 24.2%, and retrograde in 25.8%. The mean procedure time, fluoroscopy time, and air kerma radiation exposure until CTO crossing or stopping the procedure were 66 ± 55 minutes, 25 ± 23 minutes, and 2.3 ± 1.9 Gray, respectively. Three patients (4.1%) had a major complication.

Conclusion

In the “hybrid approach” to CTO PCI, changes in crossing strategy were needed in approximately half the cases, resulting in high success and low complication rates. (J Interven Cardiol 2014;27:36–43)

     

Impact of Diabetes Mellitus on Intravascular Ultrasound‐Guided Provisional Stenting in Coronary Bifurcation Lesions J‐REVERSE Sub‐Study

Objective

To investigate the impact of diabetes mellitus (DM) on provisional coronary bifurcation stenting under the complete guidance of intravascular‐ultrasound (IVUS).

Background

The efficacy of such intervention has not yet been fully elucidated in the DM patients.

Methods

A total of 100 DM and 139 non‐DM patients in a prospective multi‐center registry of IVUS‐guided bifurcation stenting were compared in angiographic results at 9 months. Vessel and luminal changes during the intervention were analyzed using the IVUS. Vascular healing at the follow‐up was also investigated in 23 lesions in each group using optical coherence tomography (OCT).

Results

No difference was detected regarding baseline reference vessel diameter and minimum lumen diameter in proximal main vessel (MV), distal MV, and side branch (SB). The rate of everolimus‐eluting stent use (78.4% vs. 78.3%), final kissing inflation (60.1% vs. 49.0%), and conversion to 2‐stent strategy (2.9% vs. 2.8%) were also similar. In the DM group, late loss was greater in proximal MV (DM 0.23 ± 0.29 vs. non‐DM 0.16 ± 0.24 mm, P < 0.05) and SB (0.04 ± 0.49 vs. ?0.08 ± 0.35 mm, P < 0.05). Smaller vessel area restricted stent expansion in the proximal MV (6.18 ± 1.67 vs. 6.72 ± 2.07 mm², P < 0.05). More inhomogeneous neointimal coverage (unevenness score, 1.90 ± 0.33 vs. 1.72 ± 0.29, P < 0.05) and more frequent thrombus attachment (26% vs. 4%, P < 0.05) were documented in the proximal MV at 9‐month follow‐up OCT.

Conclusions

Despite IVUS optimization for coronary bifurcation, DM is potentially associated with smaller luminal gain, higher late‐loss, and inhomogeneous vascular healing with frequent thrombus attachment in the proximal MV.

     

Bivalirudin versus heparin and provisional GP IIb/IIIa inhibitors in patients treated for ST‐segment elevation myocardial infarctions: Comparison of outcomes in a “real‐world” setting

Introduction

The beneficial effects of bivalirudin during primary PCIs are controversially discussed, data on unselected patients are rare. It was the aim of the study to compare bivalirudin versus heparin and provisional glycoprotein IIb/IIIa inhibitors (GPIs) in a “real‐world” study.

Methods

From 05/2013 until 11/2014, the STEMI‐patients in the Bremen STEMI registry were treated with periinterventional bivalirudin; before and after this period the standard anticoagulative treatment was heparin and provisional GPIs.

Results

In 714 patients bivalirudin was used for PCI, this cohort was compared to 683 patients with heparin and provisional GPIs. In patients with bivalirudin a significantly lower rate of hospital bleedings was observed compared to patients with heparin (4.6% vs 8.1%, P < 0.01, multivariate HR 0.57, 95%CI 0.35‐0.93), in an exclusive analysis of severe bleedings a trend toward less bleedings was found in patients with bivalirudin (2.0% vs 3.5%, P = 0.07, multivariate HR 0.66, 95%CI 0.30‐1.42). The rate of stent thromboses reinfarctions and mortality was not different between the bivalirudin and the heparin group. During 1‐year follow‐up bivalirudin was associated with a lower rate of bleedings and no significant differences in stent thromboses, reinfarctions, and mortality. Bivalirudin was not associated with an excess of bleedings or stent thromboses in subgroups that are regularly underrepresented in randomized trials (older patients, women, cardiogenic shock).

Conclusions

In this “real‐world” cohort of patients with STEMI bivalirudin compared to heparin and GPIs was associated with less bleedings and no significant differences in stent thromboses, reinfarctions, and mortality during hospital and long‐term course.

     

Comparison of Two Risk Models in Predicting the Incidence of Contrast‐Induced Nephropathy after Percutaneous Coronary Intervention

Objectives

We sought to compare 2 contrast‐induced nephropathy (CIN) risk prediction models in a validation cohort using a consensus definition.

Background

Contrast‐induced nephropathy (CIN) is independently associated with mortality following percutaneous coronary intervention (PCI). Multiple prediction models for the development of CIN have been published using heterogeneous outcome definitions.

Methods

We analyzed 5,540 patients who underwent PCI from January 2005 to June 2012 at a single academic medical center. The primary outcome was development of CIN, defined as an increase in serum creatinine of ≥0.5 mg/dl or a relative increase of ≥25% from baseline. Receiver operator characteristic (ROC) curves were used to evaluate the discriminatory power of Mehran and WBH prediction models.

Results

The mean age of our cohort was 68 ± 12 years. The mean baseline creatinine was 1.2 ± 0.53 mg/dl (eGFR 73 ± 27 ml/min). The mean contrast volume used was 212 ± 92 ml. CIN occurred in 436 patients (7.9%). The Mehran risk score demonstrated better discrimination than the William Beaumont Hospital (WBH) risk score to predict the occurrence of CIN (c statistic: 0.82 vs. 0.73, respectively). Mortality at 30 days was approximately 8 times higher among patients with CIN as compared to those without (14.7% vs. 1.8% P < 0.01).

Conclusions

In an independent validation cohort, the Mehran risk model demonstrates greater discriminatory power than the WBH model in predicting the incidence of CIN. Mortality was significantly higher in patients who developed CIN after PCI.

     

Feasibility and clinical outcomes of rotational atherectomy for heavily‐calcified side branches of complex coronary bifurcation lesions in the real‐world practice of the drug‐eluting stent era

Objectives

To evaluate the outcomes of rotational atherectomy for heavily‐calcified side branches of coronary bifurcation lesions.

Background

Side‐branch (SB) preservation is clinically important but technically challenging in heavily‐calcified non‐left main true bifurcation lesions. SB rotational atherectomy (SB RA) is sometimes mandatory but the clinical outcomes are not well studied.

Methods

We retrospectively studied the outcomes of patients who underwent RA at our institute for heavily calcified, balloon‐uncrossable or—undilatable SB lesions over an approximately 5‐year period (January 2011 to September 2016).

Results

Two hundred and forty‐four patients underwent main vessel only RA (SB?MV + RA group) and another 48 patients underwent SB RA (SB + MV ± RA group) for 49 side branches. The demographic variables were comparable between the two groups. However, patients underwent SB RA experienced more SB perforations and greater acute contrast‐induced nephropathy (CIN). Among the SB RA patients, 30 (62.5%) underwent RA for both SB and MV (SB + MV + RA subgroup), whereas the other 18 underwent SB only RA (SB + MV?RA subgroup). Patients in these two subgroups could be completed with similar procedural, fluoroscopic durations, and contrast doses. The long‐term MACE rate of SB RA was 27.1% over a mean follow‐up period of 25.1 months with no differences between the two subgroups.

Conclusions

RA for SB preservation in complex and heavily‐calcified bifurcation lesions was feasible with high success rate and quite favorable long‐term outcomes in the drug‐eluting stent (DES) era. Given the higher rates in SB perforation and acute CIN, we recommend that SB RA should be conducted by experienced operators.

     

Valve‐in‐valve transcatheter aortic valve implantation with CoreValve/Evolut R© for degenerated small versus bigger bioprostheses

Objectives

We present our single center experience with Medtronic CoreValve and Evolut R regarding procedural outcome and 3 years follow‐up in patients with degenerated bioprostheses.

Methods

From 1645 patients who underwent transfemoral TAVI at our institution between February 2009 and December 2016, 37 patients with degenerated bioprosthesis were treated with Medtronic CoreValve/Evolut R. All data concerning baseline characteristic, procedural outcomes and follow‐up were entered into a dedicated database.

Results

Mean age was 83.9 ± 4.4 years and patients showed an average logistic EuroSCORE of 33.2 ± 16.7%. Successful ViV deployment was achieved in all cases, a permanent pacemaker was implanted in 16.2%, no periinterventional stroke and no coronary obstruction occurred. Mortality at 30 days was 2.7%, at 1‐year follow‐up 5.7% and at three years 13.5%. Depending on bioprosthesis size <23 mm versus ≥23 mm echocardiographic mean gradients post implantation were significantly higher in the smaller bioprostheses, 22.8 mmHg ± 9.4 mmHg versus 15.1 ± 7.1, P = 0.013.

Conclusion

ViV‐TAVI with CoreValve/R is demonstrated to be safe and effective in terms of no coronary obstruction and very low mortality up to 3 years despite slightly higher mean transprosthetic gradients especially in very small bioprostheses.