Vascular access site complication in transfemoral coronary angiography between uninterrupted warfarin and heparin bridging

Background

Warfarin discontinuation with heparin bridging is a common practice in patients receiving warfarin prior to elective coronary angiography (CAG). The uninterrupted warfarin strategy has been suggested to be alternative option for patients with high thromboembolic risk. Therefore, we aimed to assess the safety of elective transfemoral CAG during uninterrupted warfarin therapy compared to heparin bridging.

Methods

This study was a randomized open‐label design with blinded event evaluation. The 110 consecutive patients (age ≥ 18 years) receiving warfarin before the planned transfemoral CAG were randomly assigned to either heparin bridging or uninterrupted warfarin with targeted INR (2.0‐3.0). The primary outcome was the incidence of major vascular access site complications.

Results

The baseline characteristics were comparable between two groups (mean age was 60.1 ± 7.8 years, 49 males). The mean INR on the day of CAG of heparin bridging and uninterrupted warfarin groups was 1.2 ± 0.3 and 2.2 ± 0.5 (P < 0.001). The major vascular access site complications occurred in 3 of 55 (5.5%) heparin‐bridging patients and in none of 55 uninterrupted warfarin patients (P = 0.243). The total vascular access site complications occurred in 6 (10.9%) heparin‐bridging and one (1.8%) uninterrupted warfarin patients (P = 0.113). No patient developed either other bleeding or thromboembolic events during 7 days after CAG.

Conclusions

We demonstrated that an uninterrupted warfarin strategy did not increase vascular access site complications in patients undergoing transfemoral CAG compared to heparin bridging therapy. Due to the safety and the ease of uninterrupted warfarin strategy, this approach should be encouraged in patients receiving long‐term warfarin who undergo elective transfemoral CAG.

     

The comparative safety of abciximab versus eptifibatide in patients on dialysis undergoing percutaneous coronary intervention: Insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2)

Objectives

We sought to evaluate the patterns of use and outcomes associated with eptifibatide and abciximab administration among dialysis patients who underwent percutaneous coronary intervention (PCI).

Background

Contraindicated medications are frequently administered to dialysis patients undergoing PCI often resulting in adverse outcomes. Eptifibatide is a glycoprotein IIb/IIIa inhibitor that is often used during PCI and is contraindicated in dialysis.

Methods

We included dialysis patients who underwent PCI from January 2010 to September 2015 at 47 hospitals in Michigan. We compared outcomes between patients who received eptifibatide compared with abciximab. Both groups required concurrent treatment with unfractionated heparin only. In‐hospital outcomes included repeat PCI, bleeding, major bleeding, need for transfusion, and death. Optimal full matching was used to adjust for non‐random drug administration.

Results

Of 177 963 patients who underwent PCI, 4303 (2.4%) were on dialysis. Among those, 384 (8.9%) received eptifibatide and 100 (2.3%) received abciximab. Prior to matching, patients who received eptifibatide had higher pre‐procedural hemoglobin levels (11.3 g/dL vs. 10.7 g/dL; P < 0.001) and less frequently had a history of myocardial infarction (36.5% vs. 52.0%; P = 0.005). After matching, there were no significant differences in in‐hospital outcomes between eptifibatide and abciximab including transfusion (aOR: 1.15; 95%CI: 0.55‐2.40; P = 0.70), bleeding (1.47; 0.64‐3.40; P = 0.36), major bleeding (4.68; 0.42‐52.3; P = 0.21), repeat PCI (0.38; 0.03‐4.23; P = 0.43), and death (1.53; 0.2‐9.05; P = 0.64).

Conclusions

Despite being contraindicated in dialysis, eptifibatide was used approximately 3.5 times more frequently than abciximab among dialysis patients undergoing PCI but was associated with similar in‐hospital outcomes.

     

An Audit of Outcomes After Same‐Day Discharge Post‐PCI in Acute Coronary Syndrome and Elective Patients

Objectives

To investigate the outcomes of a cohort of acute and elective percutaneous coronary intervention (PCI) patients who were discharged home 6 hours postprocedure.

Background

Contemporary PCI is safe with a low rate of acute complications. It is well established as a day procedure in elective cases; however, data are lacking in acute cases.

Methods

We describe a prospective observational audit of routine clinical practice in the 3 PCI centers in Northern Ireland. Patients were selected for same‐day discharge after 6 hours of post‐PCI observation. Both elective and acute coronary syndrome (ACS) cases were included. Criteria for same‐day discharge were based on the technical result of the procedure rather than lesion complexity or clinical presentation. Radial access was preferred but not mandatory. Patients were contacted directly to assess for 30‐day major adverse cardiovascular events (MACE). Reported events were corroborated with the general practitioner or hospital notes.

Results

A total of 1,059 patients were selected for same‐day discharge with 30‐day follow‐up available for all cases. Of these, 766 (72.3%) were elective and 293 (27.7%) were ACS patients. Radial access was almost universal (98%). A total of 1,224 lesions were stented, of which 432 (40.8%) were high risk (highest risk lesion in each case by AHA/ACC classification). MACE rate at 30 days was 0.85% with a sub‐acute stent thrombosis rate of 0.4%. There were no MACE events from discharge to 24 hours.

Conclusions

Selected acute and elective patients with a range of lesion complexity and risk can be discharged safely home early after PCI.

     

A Randomized Trial of Creatine‐kinase Leak After Rosuvastatin in Elective Percutaneous Coronary Intervention (CLEAR‐PCI)

Objectives

To determine the impact of percutaneous coronary intervention (PCI) performed at the same time of the peak concentration of rosuvastatin to reduce periprocedural myocardial infarction (PMI).

Background

Prior studies suggest that a high dose of statin before PCI reduce periprocedural myocardial infarction. However, there is no information regarding the elective PCI performed at the time of the peak of statin concentration to reduce PMI.

Methods

From 2001 to 2013, at a single center in Brazil we enrolled 544 patients who underwent elective PCI and after exclusions for baseline biases in clinical and angiographic characteristics, yielding 528 patients, we prospectively randomly assigned them to either a high loading dose of Rosuvastatin before PCI (n = 264) or standard treatment (n = 264). After exclusions for biases in procedural characteristics a total of 487 patients underwent to end points analysis. The primary outcome was the incidence of MB fraction of creatine kinase (CK‐MB) greater than three times the upper limit of normal.

Results

The primary end point occurred in 7.6% in the rosuvastatin and 4.8% in the control group (P = 0.200). There was a higher incidence in elevation of CK‐MB than normal baseline in the rosuvastatin (67.1% vs 59.2%, P = 0.701). There was no difference in major adverse event (0% in the rosuvastatin group vs 0.8% in control).

     

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.

     

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.

     

Percutaneous Coronary Intervention of Complex Calcified Lesions With Drug‐Coated Balloon After Rotational Atherectomy

Objectives

We investigated the safety and efficacy of PCI using drug‐coated balloon (DCB) after rotational atherectomy (rotablation) in a retrospective single center study in patients with calcified de novo coronary lesions. The majority of patients had an increased risk for bleeding.

Background

DCB has been effective in the treatment of in‐stent restenosis, small vessels, and bifurcations. DCB enables short one month dual antiplatelet treatment. No published data exist on the use of DCB after rotablation.

Methods

82 PCIs were performed in 65 patients (mean age 72 ± 10 years) using rotablation followed by DCB treatment. The median follow‐up time was 17 months. 82% of the patients had at least one risk factor for bleeding such as oral anticoagulation. 32% had an acute coronary syndrome. Median duration of dual antiplatelet treatment was 1 month.

Results

MACE (the composite of cardiovascular death, ischemia‐driven target‐lesion revascularization [TLR] or non‐fatal myocardial infarction) occurred in 14% and 20% of the patients at 12 and 24 months, respectively. The rate of ischemia‐driven TLR was 1.5% at 12 months and 3.0% at 24 months. No acute closure of the treated vessel occurred. Bailout stenting was needed in 10% of the PCIs. The incidence of significant bleeding was 9% at 12 months.

Conclusions

This is the first study to show that PCI using DCB after preparation of calcified lesions with rotablation is safe and effective. This novel strategy may be considered especially in patients with a bleeding risk such as those using an oral anticoagulant.

     

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)

     

Institutional Switch from Transfemoral to Transradial Vascular Access for Percutaneous Coronary Intervention was Associated with a Reduction in Bleeding Events: A Singlecenter Experience of >10,000 Consecutive Cases

Background

Transradial (TR) access for percutaneous coronary intervention (PCI) reduces bleeding compared with transfemoral (TF) access, and may reduce mortality in specific patient subsets. However, switching from TF to TR access is associated with a learning curve and it is unclear whether benefits observed in randomized trials translate into practice. We sought to characterize the trends in bleeding and mortality rates at our institution, as we changed from being a TF to predominantly TR center over a 5‐year period.

Methods and Results

10,213 consecutive patients presenting for PCI were included (mean age 65.0 ± 11.6 years, 76.1% male, 48.0% PCI for acute coronary syndrome) over 5 years at a single center with PCI volume >2,000 cases per annum. Patients were stratified by initial arterial access site (TR or TF) and outcome measures included temporal trends in TR procedural failure, 30‐day bleeding complications and all‐cause 1‐year mortality. TR procedural failure fell to a consistently low rate within 1 year (11.8% in 2008 to 2.9% in 2009, P < 0.001). As TR volume increased, the annual 30‐day bleeding rate fell (1.64% in 2008 to 0.68% in 2012, P = 0.006). TR access predicted reduced 30‐day bleeding (OR 0.17 [95%CI 0.07–0.38], P < 0.001), but was not a predictor of 1‐year survival (HR 0.78 [95%CI 0.58–1.05], P = 0.10).

Conclusion

Successful transition from TF to TR PCI at our institution was rapid and associated with a reduction in 30‐day bleeding. These data should encourage other centers considering the adoption of TR access. (J Interven Cardiol 2015;28:296–304)

     

A Pilot Study of Prasugrel Followed by Post‐Procedural Maintenance with Clopidogrel in Patients Receiving Percutaneous Coronary Intervention

Background

Dual anti‐platelet therapy including clopidogrel or prasugrel is standard of care for patients receiving stents. Prasugrel has quicker onset so it can be loaded later than clopidogrel with greater efficacy. However, prasugrel is much more expensive than clopidogrel.

Objectives

To describe the incidence of 30‐day death from cardiovascular causes, myocardial infarction, unstable angina requiring intervention, and minor and major bleeding in patients loaded with 60 mg of prasugrel prior to percutaneous coronary intervention (PCI) and then continued on 75 mg of clopidogrel daily after the procedure.

Methods

We reviewed sequential medical records of 102 patients (Mean age: 67.8, male 68.6%, smokers: 22.6%, BMI: 29.5%, hypertension: 90.2%, DM: 33.3%, average ejection fraction: 49.7%) who underwent PCI (3.9% STEMI, 12.7% NSTEMI, 35.3% unstable angina and 48.1% electively) at Baylor University Medical Center between October 2009 and December 2011 who were loaded with prasugrel 60 mg prior to procedure, and then continued on 75 mg clopidogrel daily.

Results

None of the patients died or experienced a myocardial infarction (MI) within 30 days of the procedure. Three patients experienced unstable angina requiring intervention but none had in‐stent thrombosis or restenosis on repeat angiography. None of the patients experienced a major bleeding event. One patient developed a gastrointestinal bleed which did not require blood transfusion and the bleeding it resolved on discontinuation of the clopidogrel.

Conclusion

In this retrospective pilot study, a strategy of loading patients needing PCI with prasugrel 60 mg immediately prior to coronary intervention, then continuation of anti‐platelet therapy with 75 mg clopidogrel daily was safe and effective. (J Interven Cardiol 2013;26:38–42)

     

Rationale and Design of the On‐Treatment PLAtelet Reactivity‐Guided Therapy Modification FOR ST‐Segment Elevation Myocardial Infarction (PLATFORM) Randomized Trial

Objectives

The present trial aims at examining whether antiplatelet regimen modification, guided by assessment of the on‐treatment platelet reactivity, might result with clinical benefit in moderate to high‐risk patients with ST‐elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).

Background

High platelet reactivity has been associated with an increased rate of ischemic events after PCI. Recent large trials did not show a clinical benefit of platelet reactivity‐guided therapy modification in acute coronary syndrome patients treated by PCI.

Methods

PLATFORM is an investigator‐initiated, prospective, randomized, parallel‐group, controlled clinical trial. Approximately 632 STEMI patients with intermediate to high‐risk (RISK‐PCI score >3) clinical features undergoing PPCI will be randomly allocated to treatment modification or standard therapy. Low responders to aspirin will receive 200 mg aspirin for 30 days. Low responders to clopidogrel will receive 180 mg ticagrelor for 1 year. The primary end‐point is the time to the first composite major adverse cardiovascular events (MACE) including death, nonfatal infarction, stroke, or immediate target vessel revascularization. Key safety end‐point is the rate of TIMI major bleeding unrelated to coronary artery bypass graft surgery. Our secondary end‐points are individual components of MACE, definite stent thrombosis, total bleeding, and the need for blood transfusions. Patients will be followed‐up at 30 days and at 1 year after PPCI.

Conclusion

PLATFORM will determine whether the platelet reactivity‐guided use of ticagrelor in combination with 200 mg aspirin, compared with standard antiplatelet regimen, improves clinical outcome in moderate to high‐risk STEMI patients undergoing PPCI.

Clinical Trial Registration

U.S. National Institutes of Health (NIH) at www.clinicaltrials.gov . ClinicalTrials.gov Identifier: NCT01739556, and Current Controlled Trials at www.controlledtrials.com . International Standard Randomized Controlled Trial Number ISRCTN83081599. (J Interven Cardiol 2013;26:221–227)

     

Comparison of a Safety Strategy Using Transradial Access and Dual‐Axis Rotational Coronary Angiography with Transfemoral Access and Standard Coronary Angiography

Objectives

We sought to investigate the radiation exposure and contrast utilization associated with using a strategy of transradial access and rotational angiography (radial‐DARCA) compared to the traditional approach of transfemoral access and standard angiography (femoral‐SA).

Background

There is an increased focus on optimizing patient safety during cardiac catheterization procedures. Professional guidelines have highlighted physician responsibility to minimize radiation doses and contrast volume. Dual axis rotational coronary angiography (DARCA) is the most recently investigated type of rotational angiography. This new technique permits complete visualization of the left or right coronary tree with a single injection, and is felt to reduce contrast and radiation exposure.

Methods

A total of 56 consecutive patients who underwent radial‐DARCA were identified. From the same time period, an age‐ and gender‐matched group of 61 patients who had femoral‐SA were selected for comparison. Total volume of contrast agent used, fluoroscopy time, and 2 measures of radiation dose (dose area product and air kerma) were recorded for each group.

Results

Mean contrast agent use and patient radiation exposure of the radial‐DARCA group were significantly less than that of the femoral‐SA group. There was no significant difference in fluoroscopy time between the 2 groups.

Conclusions

Physicians can successfully employ an innovative safety strategy of transradial access combined with DARCA that is feasible and is associated with lower radiation doses and contrast volume than femoral artery access and traditional coronary angiography approach. (J Interven Cardiol 2013;26:524‐529)

     

Longitudinal Geographic Miss (LGM) in Robotic Assisted Versus Manual Percutaneous Coronary Interventions

Objectives

To evaluate the impact of robotic‐assisted percutaneous coronary intervention (RA‐PCI) versus manual PCI (M‐PCI) on the incidence of Longitudinal Geographic Miss (LGM).

Background

The safety and feasibility of RA‐PCI has been established in preclinical animal trials and human clinical trials. Patients with LGM have been shown to have worse clinical outcomes including significantly increased incidences of MACE.

Methods

Patients with significant coronary artery disease underwent RA‐PCI in the PRECISE study (n=164) and standard M‐PCI in the STLLR trial (n = 1,509). Longitudinal geographic miss was defined as cases where the entire length of the injured or stenotic segment was not fully covered by the total length of the stent. The incidence of LGM was compared between RA‐PCI and M‐PCI cohorts.

Results

The RA‐PCI cohort had a significantly greater prevalence of previous MI, previous coronary revascularization, and unstable angina. The robotic cohort exhibited a lower incidence of LGM when compared to the M‐PCI patients, 12.2% to 43.1%, respectively (P < 0.0001). To account for the differences in baseline characteristics between the two studies, a propensity score analysis was conducted. The propensity modeling showed similar rates of LGM in both a larger group of patients that met key PRECISE study inclusion/exclusion criteria adjusted for propensity score (9.3% vs 55.0%; P < 0.0001) and in a smaller, matched on propensity score, subset of patients (10.3% vs 64.1%; P < 0.0001).

Conclusion

Robotic‐assisted PCI had significantly lower incidence of LGM compared to standard M‐PCI. Reducing LGM potentially improves long‐term clinical outcomes through reduction in MACE. (J Interven Cardiol 2015;28:449–455)

     

Recurrent Myocardial Infarction After Primary Percutaneous Coronary Intervention in Multivessel Coronary Disease Is Primarily Related to Stent Failure

Objectives

Our aim was to investigate the risk of events related to non‐culprit lesions after primary percutaneous coronary intervention (PCI) in patients with multivessel coronary disease (MVD).

Background

In patients undergoing primary PCI for ST‐elevation myocardial infarction (STEMI) who are diagnosed with MVD, the optimal treatment strategy is currently under debate. Although observational data exposed an increased risk of multivessel PCI in the acute phase of STEMI, 2 recently published randomized controlled trials showed a reduction of death or recurrent myocardial infarction (MI) after preventive PCI of non‐culprit lesions when compared with culprit‐lesion PCI only.

Methods

We performed a post‐hoc analysis of 279 patients with MVD included in the Paclitaxel‐Eluting Stent versus Conventional Stent in Myocardial Infarction with ST‐Segment Elevation (PASSION) trial. We analyzed the incidence and cause of recurrent MI. Recurrent MI due to stent failure was assumed in the event of definite or probable stent thrombosis.

Results

After 5 years, 14 patients (5.7%) with MVD had a recurrent MI versus 17 (5.4%) patients with 1‐vessel disease (HR 1.06, 95%CI 0.52–2.15, P = 0.87). The majority of events was attributable to stent failure, while of the remaining 6 events, only 1 was proven to originate from a lesion that was judged significant at enrolment.

Conclusions

In this post‐hoc analysis of the PASSION trial, recurrent MI in patients with MVD was mainly related to stent failure rather than a new event originating from a significant stenosis in a non‐culprit coronary artery. (J Interven Cardiol 2015;28:523–530)

     

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.

     

Balloon‐Expandable Transcatheter Aortic Valves Can Be Successfully and Safely Implanted Transfemorally Without Balloon Valvuloplasty

Objectives

To assess the necessity for balloon aortic valvuloplasty (BAV) during transfemoral transcatheter aortic valve implantation (TAVI) when using balloon‐expandable valves.

Background

BAV is a usual part of TAVI procedures, prior to valve implantation. However, the benefits and necessity of this are unknown and recent evidence in self‐expanding valves suggests it may not be necessary.

Methods

Retrospective single‐center study of 154 patients undergoing first‐time, transfemoral TAVI for native aortic valve stenosis, with (N = 76), and without (N = 78), BAV as part of the procedure. Data collected included demographic, procedural, and outcome data.

Results

BAV did not alter VARC‐2 defined procedural success or early safety compared to not performing a BAV, including mortality, degree of aortic regurgitation, or need for post‐TAVI balloon dilatation, although there was a strong trend to reduced stroke when not performing a BAV. There was a significantly reduced procedural time (P = 0.01) and fluoroscopic time (P < 0.001) without performing a BAV. There were no differences in cerebral embolization (solid, gaseous, or total emboli) noted between the 2 groups, as measured on transcranial doppler (TCD).

Conclusions

TAVI can be effectively and safely performed without a BAV and this results in reduced procedural and fluoroscopic times, although embolization to the brain is not reduced. There is a trend toward reduced stroke risk. (J Interven Cardiol 2016;29:319–324)

     

Safety and Efficacy of Immediate Rotational Atherectomy in Nondilatable Calcified Coronary Lesions Complicated by Coronary Artery Dissection (RAISE)

Objectives

To examine the safety and efficacy of immediate rotational atherectomy (RA) in nondilatable calcified coronary lesions complicated by coronary dissection during percutaneous coronary intervention (PCI).

Background

In the presence of coronary dissection in nondilatable calcified coronary lesions, conservative management is suggested to permit the dissection to heal prior to treatment with RA. However, many patients have frequent angina attacks and some patients develop serious complications during this period.

Methods

One hundred and nighty‐eight patients with severe coronary calcification underwent PCI, and were randomized into immediate (n = 105) or delayed RA group (n = 93) when coronary dissections occur. The primary endpoint of the present study was all‐cause death including cardiac and non‐cardiac death in 4 years follow‐up. Non‐fatal myocardial infarction, stent thrombosis, cardiac tamponade, stroke, target lesion revascularization, New York Heart Association (NYHA) class IV heart failure were analyzed as secondary end points.

Results

At a follow‐up of 4 years, event‐free survival rates were not statistically different between the immediate and delayed RA group (81.9% vs 80.6%, P = 0.820). Rates of PCI‐ and RA‐related major adverse cardiac events (MACE) and severe RA‐related complications were not statistically different between groups. Luminal loss was not significantly different between the immediate and delayed RA group as evaluated by Intravascular ultrasound (IVUS). Two cases in the delayed RA group experienced myocardial infarction during the 4‐week waiting.

Conclusion

This study indicates that immediate RA during PCI is safe and effective in patients with coronary artery dissection. (J Interven Cardiol 2015;28:456–463)

     

Femoral Access PCI in a Default Radial Center Identifies High‐Risk Patients With Poor Outcomes

Background

Increasingly the trans‐radial route (TRR) is preferred over the trans‐femoral route (TFR) for PCI. However, even in high volume default TRR centers a cohort of patients undergo TFR PCI. We examined the demographics, procedural characteristics, and outcomes of patients undergoing PCI via the TF.

Methods

The patient demographics, procedural data, and outcomes of 5,379 consecutive patients undergoing PCI at a default radial center between 2009 and 2012 were examined. Major bleeding (MB) was classified by ACUITY and BARC definitions.

Results

A total of 559 (10.4%) patients underwent PCI via the TFR and 4,820 patients via the TRR (89.6%). Baseline variables associated with TFR were shock, previous CABG, chronic total occlusion intervention, rotablation/laser use, female sex, and renal failure. Sixty‐five patients of the TFR cohort (11.6%) experienced MB with 27 (41.5%) being access site related. MB was significantly more frequent than in the radial cohort. The variables independently associated with MB in the TFR cohort were renal failure, acute presentation, shock, and age. In the TFR, patients with MB mortality was high at 30 days (17.2% vs 2.6% for no MB, P < 0.0001) and at 1 year (37.6% vs 5.0%, P < 0.0001). Shock and MB were highly predictive of 30 day and 12 month mortality.

Conclusion

In a default radial PCI center 10% of patients undergo PCI via the femoral artery. These patients have high baseline bleeding risk and undergo complex interventions. As a result the incidence of major bleeding, transfusion and death are high. Alternative strategies are required to optimize outcomes in this select group. (J Interven Cardiol 2015;28:485–492)

     

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.