STAR procedure becomes SAFER: First-in-man case series of a new antegrade dissection re-entry technique.

INTRODUCTION: Antegrade dissection and re-entry (ADR) is an integral part of the hybrid algorithm, which has allowed for improved outcomes in chronic total occlusion (CTO) coronary intervention (PCI). METHODS: A new ADR method, Subintimal Antegrade FEnestration and Re-entry (SAFER), is described. The results of a first-in-man series are presented. RESULTS: SAFER was performed on seven consecutive patients with angiographic and clinical success in all patients. CONCLUSIONS: This first-in-man study has shown that the SAFER technique is feasible and effective with the possibility of improving the antegrade PCI CTO success rate.

Impact of lesion length on the outcomes of chronic total occlusion percutaneous coronary intervention: Insights from the PROGRESS-CTO registry.

BACKGROUND: The impact of occlusion length on the procedural techniques and outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. METHODS: We examined the clinical and angiographic characteristics and procedural outcomes of 10,335 CTO PCIs at 42 US and non-US centers between 2012 and 2022. The cohort was divided into two groups based on lesion length (≥20 mm vs. <20 mm). RESULTS: Long lesions were present in 7208 (70%) patients. Comorbidities were more common in patients with long CTOs. Compared with short lesions, long lesions had higher J-CTO score (2.8 ± 1.1 vs. 1.3 ± 1; p < 0.001) and retrograde wiring was more often the initial (15.5% vs. 4.0%; p < 0.001) and successful (22.8% vs. 8.2%; p < 0.001) crossing strategy. Long lesions were more likely to require longer procedure (123 vs. 91 min; p < 0.001) and fluoroscopy (47.1 vs. 32.2 min; p < 0.001) time, larger contrast volume (218 vs. 200 mL; p < 0.001) and higher air kerma radiation dose (2.4 vs. 1.7 Gy; p < 0.001). After adjusting for potential confounders, long lesions were associated with lower technical success (odds ratio [OR]: 0.91 per 10 mm increase; 95% confidence interval [CI]: 0.88, 0.94) and higher major adverse cardiovascular events (MACE) (OR: 1.08 per 10 mm increase; 95% CI: 1.02, 1.15). CONCLUSIONS: CTO PCI of long occlusions is independently associated with lower rates of technical success and higher rates of in-hospital MACE.

Elective percutaneous coronary intervention performed during contrast-induced hypotension.

OBJECTIVES: To demonstrate the feasibility and safety of performing elective percutaneous coronary intervention (PCI) during contrast reaction producing severe hypotension. BACKGROUND: The development of profound hypotension due to a contrast reaction requires emergency treatment and usually signals procedure termination. METHODS AND RESULTS: We report successful completion of planned PCI with blood pressure support with vasopressors during contrast-induced hypotension in nine procedures in three patients with previously known contrast reaction causing hypotension. CONCLUSIONS: This case series provides support for the feasibility and safety of performing successful planned PCI under blood pressure support in patients with contrast reaction causing severe hypotension. A management approach for considering intervention in the setting of contrast-induced hypotension is provided.

Impact of severity of baseline thrombocytopenia on outcomes after percutaneous coronary interventions: Analysis from the Veterans Affairs Clinical Assessment, Reporting, and Tracking (VA CART) Program.

OBJECTIVES: The aim of this study was to evaluate the effect of the degree of severity of baseline thrombocytopenia (TCP) on outcomes after percutaneous coronary intervention (PCI) BACKGROUND: The association of TCP with clinical outcomes among patients undergoing coronary intervention has not been previously evaluated. METHODS: Using data from the US Veterans Affairs Clinical Assessment, Reporting, and Tracking (CART) Program, we identified patients undergoing PCI between October 1, 2007, to September 30, 2017. The cohort was then stratified by platelet count, as no TCP (platelet count >150,000/mcl), mild TCP (100-150,000/mcl), or moderate-severe TCP (<100,000/mcl) and this was associated with clinical outcomes. RESULTS: The cohort included 80,427 patients (98% male), of which 14.9% (13.2% mild, 1.7% moderate-severe) suffered from TCP at the time of PCI. Compared with mild or no TCP, moderate-severe TCP was associated with increased risk of post-PCI pericardiocentesis (0.6% vs. 0.2% vs. 0.2%, p = 0.018) and in-hospital mortality (1.5% vs. 0.7% vs. 0.7%) without a difference in postprocedure stroke (0.5% vs. 0.3% vs. 0.3%, p = 0.6). Over a median follow-up of 1729 days, time-to-repeat revascularization was significantly shorter in moderate-severe TCP (1080 vs. 1347 vs. 1467 days, p < 0.001) despite lower risk of revascularization. Both mild (adjusted HR: 1.11, 95% CI: 1.07-1.15, p < 0.001) and moderate-severe TCP (HR: 1.55, 95% CI: 1.43-1.69, p < 0.001) were associated with increased all-cause mortality compared with those without TCP. CONCLUSIONS: Thrombocytopenia was associated with increased short- and long-term adverse events among patients undergoing PCI. Any degree of TCP was associated with increased long-term all-cause mortality while moderate-severe TCP was also associated with increased risk of periprocedural adverse events.

Derivation and validation of Pd/Pa in the assessment of residual ischemia post-intervention: A prospective all-comer registry.

BACKGROUND: Measurement of post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) demonstrates residual ischemia in a large percentage of cases deemed angiographically successful which, in turn, has been associated with worse long-term outcomes. It has recently been shown that a resting pressure index, Pd/Pa, has prognostic value post stenting, however, its diagnostic value relative to FFR post-PCI has not been evaluated. METHODS: The diagnostic accuracy of Pd/Pa in identifying ischemia (FFR≤0.80) pre- and post-PCI was evaluated. Three patient subsets were analyzed. A reference pre-PCI cohort of 1,255 patients (1,560 vessels) was used to measure the accuracy of pre-PCI Pd/Pa vs. FFR. A derivation post-PCI group of 574 patient (664 vessels) was then used to calculate the diagnostic accuracy of post-PCI Pd/Pa vs. FFR. A final prospective validation cohort of 230 patients (255 vessels) was used to test and validate the diagnostic performance of post-PCI Pd/Pa. RESULTS: Median Pd/Pa and FFR were 0.90 (IQR 0.90-0.98) and 0.80 (IQR 0.71-0.88) in the reference pre-PCI model, 0.96 (IQR 0.93-1.00) and 0.87 (IQR 0.77-0.90) in the post-PCI derivation model, and 0.94 (IQR 0.89-0.97) and 0.84 (IQR 0.77-0.90) in the post-PCI validation model respectively. There was a strong linear correlation between Pd/Pa and FFR in all three models (p < 0.0001). Using ROC analysis, the optimal Pd/Pa cutoff value to predict a FFR ≤ 0.80 was ≤0.92 (AUC 0.87) in the pre-PCI model, ≤0.93 (AUC 0.85) in the post-PCI derivation model, and ≤ 0.90 (AUC 0.91) in the post-PCI validation model. Using a hybrid strategy of post-PCI Pd/Pa and post-PCI FFR when necessary (25% patients), overall diagnostic accuracy was improved to 95%. CONCLUSIONS: Pd/Pa has excellent diagnostic accuracy for identifying ischemia post-intervention. Using a hybrid strategy of post-PCI Pd/Pa first, and FFR afterwards, if required, adenosine administration can be avoided in over 75% of physiologic assessments post intervention.

Do We Really Need Aspirin Loading for STEMI?

Aspirin loading (chewable or intravenous) as soon as possible after presentation is a class I recommendation by current ST elevation myocardial infarction (STEMI) guidelines. Earlier achievement of therapeutic antiplatelet effects by aspirin loading has long been considered the standard of care. However, the effects of the loading dose of aspirin (alone or in addition to a chronic maintenance oral dose) have not been studied. A large proportion of myocardial cell death occurs upon and after reperfusion (reperfusion injury). Numerous agents and interventions have been shown to limit infarct size in animal models when administered before or immediately after reperfusion. However, these interventions have predominantly failed to show significant protection in clinical studies. In the current review, we raise the hypothesis that aspirin loading may be the culprit. Data obtained from animal models consistently show that statins, ticagrelor, opiates, and ischemic postconditioning limit myocardial infarct size. In most of these studies, aspirin was not administered. However, when aspirin was administered before reperfusion (as is the case in the majority of studies enrolling STEMI patients), the protective effects of statin, ticagrelor, morphine, and ischemic postconditioning were attenuated, which can be plausibly attributable to aspirin loading. We therefore suggest studying the effects of aspirin loading before reperfusion on the infarct size limiting effects of statins, ticagrelor, morphine, and/ or postconditioning in large animal models using long reperfusion periods (at least 24 h). If indeed aspirin attenuates the protective effects, clinical trials should be conducted comparing aspirin loading to alternative antiplatelet regimens without aspirin loading in patients with STEMI undergoing primary percutaneous coronary intervention.

Angio-Based Fractional Flow Reserve, Functional Pattern of Coronary Artery Disease, and Prediction of Percutaneous Coronary Intervention Result: a Proof-of-Concept Study.

PURPOSE: Wire-based coronary physiology pullback performed before percutaneous coronary intervention (PCI) discriminates coronary artery disease (CAD) distribution and extent, and is able to predict functional PCI result. No research investigated if quantitative flow ratio (QFR)-based physiology assessment is able to provide similar information. METHODS: In 111 patients (120 vessels) treated with PCI, QFR was measured both before and after PCI. Pre-PCI QFR trace was used to discriminate functional patterns of CAD (focal, serial lesions, diffuse disease, combination). Functional CAD patterns were identified analyzing changes in the QFR virtual pullback trace (qualitative method) or after computation of the QFR virtual pullback index (QVPindex) (quantitative method). QVPindex calculation was based on the maximal QFR drop over 20 mm and the length of epicardial coronary segment with QFR most relevant drop. Then, the ability of the different functional patterns of CAD to predict post-PCI QFR value was tested. RESULTS: By qualitative method, 51 (43%), 20 (17%), 15 (12%), and 34 (28%) vessels were classified as focal, serial focal lesions, diffuse disease, and combination, respectively. QVPindex values >0.71 and ≤0.51 predicted focal and diffuse patterns, respectively. Suboptimal PCI result (post-PCI QFR value ≤0.89) was present in 22 (18%) vessels. Its occurrence differed across functional patterns of CAD (focal 8% vs. serial lesions 15% vs. diffuse disease 33% vs. combination 29%, p=0.03). Similarly, QVPindex was correlated with post-PCI QFR value (r=0.62, 95% CI 0.50-0.72). CONCLUSION: Our results suggest that functional patterns of CAD based on pre-PCI QFR trace can predict the functional outcome after PCI. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , number NCT02811796. Date of registration: June 23, 2016.

Systematic review of the evaluation and management of coronary pseudoaneurysm after stent implantation.

Pseudoaneurysm (PSA) formation is a rare but well-known complication of coronary stenting. It develops after a procedural perforation disrupts the integrity of the vessel wall but is contained by a single wall layer, usually pericardium, extravascular thrombosis and later fibrosis. Medical literature of PSA consists primarily of case reports. A systematic review of pseudoaneurysm after coronary stenting was performed to summarize its presentation, diagnostic imaging modalities, natural history, and management approaches. Clinical presentations range from asymptomatic to hemodynamic collapse, size from small to "giant," and treatment approaches from surgical or percutaneous exclusion to "watchful waiting" and imaging surveillance. Based on current information, a management algorithm is provided recommending urgent to emergent exclusion for symptomatic PSA, elective exclusion for large and giant PSA, and "watchful waiting" and periodic imaging surveillance for small to moderate sized PSA.

Exhaustion of coronary vasodilatory reserve in the resting state: Clinical characteristics and long-term outcomes after intervention.

OBJECTIVES/BACKGROUND: Resting coronary blood flow approximates flow with maximal vasodilation in very severe coronary stenosis. We studied the incidence of exhausted vasodilatory reserve by FFR, its clinical characteristics and long-term prognosis after FFR guided percutaneous coronary intervention (PCI). METHODS: Consecutive patients undergoing FFR-guided PCI for coronary stenosis with reduced resting blood flow (baseline Pd/Pa < 0.8) were included. Basal maximal vasodilation (BMV) was defined as less than 5% difference between resting Pd/Pa and FFR, that is, FFR-baseline Pd/Pa < 0.05. RESULTS: Of 658 vessels that underwent FFR-guided PCI in 602 patients, 151 vessels had resting blood flow in the ischemic range (baseline Pd/Pa ≤ 0.8) and were included in the analysis. Of these, 28 lesions in 28 patients met criteria for BMV (4.25% of the entire registry and 18.5% of those with the reduced basal coronary flow). Stenosis severity was a significant predictor of the presence of BMV. In long term follow-up (median 106 ± 3.6 months), BMV was not associated with increased target vessel revascularization (TVR) or major adverse cardiac event compared to non-BMV(OR 1.9, 95% CI 0.7-4.8, p-value 0.2 and OR 1.3, 95% CI 0.75-2.5, p = 0.3, respectively). CONCLUSION: Low baseline Pd/Pa that approximates fractional flow reserve (exhausted vasodilatory reserve) defines a subgroup of patients with severe coronary artery stenosis. Prognosis, when treated with PCI along with medical therapy, appears similar to those with intact vasodilatory reserve.

Multicenter experience with the antegrade fenestration and reentry technique for chronic total occlusion recanalization.

OBJECTIVES: We aimed to evaluate the efficacy and safety of antegrade fenestration and reentry (AFR) for chronic total occlusion (CTO) recanalization in a multicenter registry. BACKGROUND: Adoption of antegrade dissection/reentry (ADR) for CTO recanalization has been limited, and novel ADR techniques are needed. METHODS: AFR involves the balloon-induced creation of multiple fenestrations between the false and true lumen. A targeted true lumen reentry is subsequently achieved with a low tip-load polymer-jacketed guidewire. Following the initial description and dissemination of AFR, patients undergoing AFR-based CTO recanalization at nine centers were included in the present registry. Study endpoints were AFR success, procedural success, and target-lesion failure (TLF) on follow-up. RESULTS: We included 41 patients. Mean J-CTO score was 2.5 ± 1.4. In 80.5% of cases, AFR was performed after failed antegrade wire escalation. Another ADR technique was used before AFR in one-third of cases. AFR achieved distal true lumen reentry in n = 27/41 (65.9%) cases. In n = 14/41 (34.1%) cases with AFR failure, use of alternative techniques led to successful CTO recanalization in eight additional patients. The overall technical and procedural success rates were 85.4% and 82.9%, respectively. No AFR-related complications were observed. One-year TLF rate was 8.3% overall, with no differences between successful and failed AFR. CONCLUSIONS: We report on AFR feasibility in a multicenter registry of patients undergoing CTO recanalization. We observed a moderate success rate, coupled with the absence of complications. Moreover, even a failed AFR attempt did not preclude the use of alternative techniques to achieve recanalization. Further studies should confirm and extend our findings.

Role of Postintervention Fractional Flow Reserve to Improve Procedural and Clinical Outcomes.

The value of fractional flow reserve (FFR) in determining the appropriateness of percutaneous coronary intervention (PCI) has been well established and incorporated into current guidelines and appropriate use criteria. However, the value of performing FFR after intervention is uncertain. This review provides the current evidence base highlighting the clinical and prognostic implications of post-PCI FFR. It provides evidence for improvement in post-PCI FFR with subsequent interventions (functional optimization) challenging the notion that FFR after angiographic optimization is fixed because of the underlying plaque burden. Multiple large observational studies and post hoc analyses of randomized trials have established that post-PCI FFR value is independently predictive of long-term outcomes (higher is better). The accumulated evidence suggests that post-PCI FFR be incorporated into routine practice in those patients having undergone pre-PCI FFR as part of clinical decision making.

Use of "super-glue" to seal a perforation during chronic total occlusion coronary intervention and the potential to "unglue" it.

Coronary perforation remains a dreaded complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We present a case of successful CTO recanalization complicated by a perforation treated by n-butyl-cyanoacrylate (medical "super-glue"). We also present an in vitro experiment showing that a glue plug in a plastic tube can acutely be passed by a low tip load guide wire and undergo balloon angioplasty recreating a lumen. These results suggest that n-butyl-cyanoacrylate glue may be an alternative for treating perforation during CTO PCI with the possibility of recanalizing the vessel through the glue plug at a later time.

Inferior ST-Elevation Myocardial Infarction Presenting When Urgent Primary Percutaneous Coronary Intervention Is Unavailable: Should We Adhere to Current Guidelines?

The pivotal studies that led to the recommendations for emergent reperfusion therapy for ST-elevation myocardial infarction (STEMI) were conducted for the most part over 25 years ago. At that time, contemporary standard treatments including aspirin, statin, and even anticoagulation were not commonly used. The 2013 American College of Cardiology Foundation (ACCF)/American Heart Association (AHA) guidelines and the 2017 European Society of Cardiology guidelines give a class I recommendation (with the level of evidence A) for primary percutaneous coronary intervention (pPCI) in patients with STEMI and ischemic symptoms of less than 12 h. However, if the patient presents to a hospital without pPCI capacity, and it is anticipated that pPCI cannot be performed within 120 min of first medical contact, fibrinolytic therapy is indicated (if there are no contraindications) (class I indication, level of evidence A). Our review of the pertinent literature shows that the current recommendation for inferior STEMI is based on the level of evidence lower than A. We can consider level B even C, supporting the recommendation for fibrinolytic therapy if pPCI is not available for inferior STEMI.

All stent strut malappositions are not created equal.

The current meta-analysis evaluates the relationship of late incomplete stent apposition (LISA) observed either by IVUS or OCT 6-18 months after PCI and long-term outcomes, particularly in regard to stent thrombosis (ST) and has demonstrated a small but significant increase in ST with LISA. The results of the current study do not apply to acute stent malapposition whose relevance to adverse outcomes is uncertain based on current evidence and a malapposition classification based on presence, length, and severity of malapposed struts. A classification of stent malapposition based on cause of malapposition is proposed as a method to determine prognostic importance of acute incomplete stent apposition.

Retrograde recanalization of a nonchronic total occlusion lesion.

The use of the retrograde approach to treat chronic total occlusion (CTO) has improved overall success rate in this lesion subgroup. Its use to treat complex non-CTO lesions unable to be revascularized by an antegrade approach has not been described. We report a case of the use of the retrograde approach to recanalize a non-CTO lesion under Impella support in a patient with critical stenosis and poor left ventricular function. The retrograde approach may be an alternate pathway in selected non-CTO lesions where the antegrade has been unsuccessful.

Improved stent expansion with prolonged compared with short balloon inflation: A meta-analysis.

BACKGROUND: Despite evidence from individual studies suggesting that prolonged inflation improves coronary stent expansion, relatively shorter inflation times are commonly employed in clinical practice. METHODS: We performed an electronic search of PubMed, Web of Science, Cochrane, and CINAHL databases to retrieve outcome studies comparing prolonged versus short inflation times during stent deployment. Outcomes studied included minimal stent diameter (MSD) and minimal stent area (MSA). Standardized mean difference (SMD) was used to estimate the effect sizes for these continuous variables. RESULTS: Seven studies with a total of 341 patients (415 lesions; mean age 67.6 years; 82% male) were included. Drug-eluting stents were used in 89 ± 15% of coronary lesions. Prolonged stent inflation was associated with increased minimal stent diameter (2.93 ± 0.34 mm vs. 2.72 ± 0.28 mm; SMD = 0.42; 95% CI 0.25-0.59; P < 0.001) and minimal stent area (5.99 ± 1.21 mm2 vs. 5.17 ± 0.87 mm2 ; SMD = 0.46; 95% CI 0.19-0.73; P = 0.001) compared with shorter duration stent inflation. This difference remained significant in sensitivity analyses that excluded studies with very prolonged inflation duration or multiple stent balloon inflations. CONCLUSION: Despite differences in duration and methodology, prolonged stent inflation is associated with improved expansion compared with shorter duration. The effect of this optimization recommends randomized trials to determine whether long-term outcomes can be improved by this simple technical modification.

Subadventitial techniques for chronic total occlusion percutaneous coronary intervention: The concept of "vessel architecture".

Despite improvements in guidewire technologies, the traditional antegrade wire escalation approach to chronic total occlusion (CTO) recanalization is successful in only 60-80% of selected cases. In particular, long, calcified, and tortuous occlusions are less successfully approached with a true-to-true lumen approach. Frequently, the guidewire tracks into the subadventitial space, with no guarantee of distal re-entry into the true lumen. The ability to manage the subadventitial space has been a key step in the tremendous improvement in success rates of contemporary CTO percutaneous coronary intervention (PCI), whether operating antegradely or retrogradely. A modern approach to CTO PCI involves understanding the concept of "vessel architecture," which is based on the distinction between coronary structures (occlusive plaque, comprising the disrupted intima and media, and the outer adventitia) and extravascular space. The vessel architecture represents a safe work environment for guidewire and device manipulation. This review provides an anatomy-based description of the concept of vessel architecture, along with a historical perspective of subadventitial techniques for CTO PCI, and outcome data of CTO PCI utilizing the subadventitial space. © 2017 Wiley Periodicals, Inc.