Performance of the minimalistic hybrid approach algorithm versus other conventional algorithms in the percutaneous treatment of chronic total occlusions.

BACKGROUND: The "Minimalistic Hybrid Approach" (MHA) has been proposed to reduce the invasiveness of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). AIMS: This study aims to assess whether MHA may also reduce the utilization of PCI resources (devices, radiations, and contrast) by comparing it with other conventional algorithms. METHODS: We aimed to assess the impact of MHA on device, radiation, and contrast usage during CTO-PCI analyzing data from the Belgian Working Group on CTO (BWG-CTO) registry. Patients were divided, depending on the algorithm used, into two groups: Conventional versus Minimalistic. Primary objectives were procedure performance measures such as device usage (microcatheters and guidewires), radiological parameters, and contrast use. At 1-year follow-up, patients were evaluated for target vessel failure (TVF), defined as a composite of cardiac death, new myocardial infarction, and target vessel revascularization. RESULTS: Overall, we analyzed 821 CTO-PCIs (Conventional n = 650, Minimalistic n = 171). The Minimalistic group demonstrated higher complexity of CTO lesions. After adjusting for propensity score, the Minimalistic group had a significantly lower number of microcatheters used (1.49 ± 0.85 vs. 1.24 ± 0.64, p = 0.026), while the number of guidewires was comparable (4.80 ± 3.29 vs. 4.35 ± 2.94, p = 0.30). Both groups had similar rates of success and procedural complications, as well as comparable procedural and fluoroscopic times and contrast volume used. At the 1-year follow-up, both groups showed comparable rates of TVF (hazard ratio: 0.57; 95% confidence interval: 0.24-1.34, p = 0.195). CONCLUSION: The MHA may slightly reduce the number of dedicated devices used during CTO-PCI, without adversely affecting the procedural success or long-term outcome.

Percutaneous treatment of left circumflex coronary artery injury related to mitral valve surgery: Case series and systematic review of the literature.

Left circumflex coronary artery (LCx) injury related to mitral valve surgery is a rare complication. The best treatment option is not defined, and percutaneous coronary intervention (PCI) may represent an effective treatment to avoid prolonged myocardial ischemia. To evaluate feasibility and efficacy of PCI treatment, all records of LCx injury related to mitral valve surgery and treated with PCI were included after a systematic PubMed searching. Moreover, we retrospectively analyzed our single-center PCI database and patients fulfilling the inclusion criteria were included. Patients undergoing transcatheter mitral valve intervention, non-mitral valve surgery, conservatively or surgically treated after LCx injury were excluded. Data about patient characteristics, procedural details, PCI success, and in-hospital mortality were collected. Fifty-six patients were included, 58.9% were male (n = 33) and the median age was 60.5 years (IQR = 21.75). The majority had left dominant or codominant coronary system (62.2%, n = 28 and 15.6%, n = 7, respectively). Clinical manifestations ranged from hemodynamic stability (21.1%, n = 8) to hemodynamic instability (42.1%, n = 16) and cardiac arrest (18.4%, n = 7). On ECG, 23.5% of patients (n = 12) presented ST-segment depression, 58.8% (n = 30) ST-segment elevation, 7.8% (n = 4) atrioventricular block, and 29.4% (n = 15) ventricular arrhythmias. Left ventricle dysfunction was present in 52.3% (n = 22) of patients and wall motion abnormalities in 71.4% (n = 30). PCI success rate was 82.1% (n = 46) and in-hospital mortality 4.5% (n = 2). LCx injury related to mitral surgery is a rare complication characterized by an increased risk of mortality. PCI seems a feasible treatment option, still burdened by suboptimal results, probably related to the technical challenges posed by the surgical failure.

Coils embolization use for coronary procedures: Basics, indications, and techniques.

The use of coils is fundamental in interventional cardiology and can be lifesaving in selected settings. Coils are classified by their materials into bare metal, fiber coated, and hydrogel coated, or by the deliverability method into, pushable or detachable coils. Coils are delivered through microcatheters and the choice of coil size is important to ensure compatibility with the inner diameter of the delivery catheter, firstly to be able to deliver and secondly to prevent the coil from being stuck and damaged. Clinically, coils are used in either acute or in elective setting. The most important acute indication is typically the sealing coronary perforation. In the elective settings, coils can be used for the treatment of certain congenital cardiac abnormalities, aneurysms, fistulas or in the treatment of arterial side branch steal syndrome after CABG. Coils must always be delivered under fluoroscopy guidance. There are some associated complications with coils that can be acute or chronic, that nictitates regular followed-up. There is a need for education, training and regular workshops with hands-on to build the experience to use coils in situations that are infrequently encountered.

Long-term follow-up of contemporary drug-eluting stent implantation in diabetic patients: Subanalysis of a randomized controlled trial.

OBJECTIVE: The elevated risk of adverse events following percutaneous coronary intervention in diabetic patients persists with newer-generation DES. The polymer-free amphilimus-eluting stent (PF-AES) possesses characteristics with a potentially enhanced performance in patients with diabetes. Data from the 1-year follow-up period has been previously published. The aim of this subanalysis was to assess long-term performance of two contemporary drug-eluting stents (DES) in a diabetic population. METHODS: In the ReCre8 trial, patients were stratified for diabetes and troponin status, and randomized to implantation of a permanent polymer zotarolimus-eluting stent (PP-ZES) or PF-AES. The primary endpoint was target-lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction and target-lesion revascularization. Clinical outcomes between discharge and 3 years follow-up were assessed. RESULTS: A total of 302 patients with diabetes were included in this analysis. After 3 years, TLF occurred in 12.5% of PP-ZES patients versus 10.0% in PF-AES patients (p = 0.46). Similarly, the separate components of TLF were comparable between the two study arms. The secondary composite endpoint of NACE was higher in the PP-ZES arm with 45 cases (29.6%) versus 30 cases (20.0%) in the PF-AES arm (p = 0.036). In the insulin-dependent diabetic population, TLF occurred in 19.1% of PP-ZES patients versus 10.4% of PF-AES patients (p = 0.21). NACE occurred in 40.4% of PP-ZES patients versus 27.1% of PF-AES patients (p = 0.10). CONCLUSIONS: This subanalysis shows that the use of PF-AES results in similar clinical outcomes as compared to PP-ZES, yet some benefits of use of PF-AES in diabetic patients may prevail. Future dedicated trials should confirm these findings.

Gender differences in percutaneous coronary intervention for chronic total occlusions from the ERCTO study.

BACKGROUND: Gender-specific data addressing percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) in female patients are scarce and based on small sample size studies. AIMS: We aimed to analyze gender-differences regarding in-hospital clinical outcomes after CTO-PCI. METHODS: Data from 35,449 patients enrolled in the prospective European Registry of CTOs were analyzed. The primary outcome was the comparison of procedural success rate in the two cohorts (women vs. men), defined as a final residual stenosis less than 20%, with Thrombolysis In Myocardial Infarction grade flow = 3. In-hospital major adverse cardiac and cerebrovascular events (MACCEs) and procedural complications were deemed secondary outcomes. RESULTS: Women represented 15.2% of the entire study population. They were older and more likely to have hypertension, diabetes, and renal failure, with an overall lower J-CTO score. Women showed a higher procedural success rate (adjusted OR [aOR] = 1.115, confidence interval [CI]: 1.011-1.230, p = 0.030). Apart from previous myocardial infarction and surgical revascularization, no other significant gender differences were found among predictors of procedural success. Antegrade approach with true-to-true lumen techniques was more commonly used than retrograde approach in females. No gender differences were found regarding in-hospital MACCEs (0.9% vs. 0.9%, p = 0.766), although a higher rate of procedural complications was observed in women, such as coronary perforation (3.7% vs. 2.9%, p < 0.001) and vascular complications (1.0% vs. 0.6%, p < 0.001). CONCLUSIONS: Women are understudied in contemporary CTO-PCI practice. Female sex is associated with higher procedural success after CTO-PCI, yet no sex differences were found in terms of in-hospital MACCEs. Female sex was associated with a higher rate of procedural complications.

External validation of the PROGRESS-CTO perforation risk score: Individual patient data pooled analysis of three registries.

BACKGROUND: Coronary artery perforation is one of the most feared and common complications of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: To assess the usefulness of the recently developed PROGRESS-CTO (NCT02061436) perforation risk score in independent cohorts. Individual patient-level data pooled analysis of three registries was performed. RESULTS: Of the 4566 patients who underwent CTO PCI at 25 centers, 196 (4.2%) had coronary artery perforation. Patients with perforations were older (69 ± 10 vs. 65 ± 10, p < 0.001), more likely to be women (19% vs. 13%, p = 0.009), more likely to have a history of prior coronary artery bypass graft (34% vs. 20%, p < 0.001), and unfavorable angiographic characteristics such as blunt stump (62% vs. 48%, p < 0.001), proximal cap ambiguity (52% vs. 34%, p < 0.001), and moderate-severe calcification (60% vs. 49%, p = 0.002). Technical success was lower in patients with perforations (73% vs. 88%, p < 0.001). The area under the receiver operating characteristic curve of the PROGRESS-CTO perforation risk model was 0.76 (95% confidence interval [CI], 0.72-0.79), with good calibration (Hosmer-Lemeshow p = 0.97). We found that the CTO PCI perforation risk increased with higher PROGRESS-CTO perforation scores: 0.3% (score 0), 2.3% (score 1), 3.1% (score 2), 5.5% (score 3), 7.5% (score 4), 14.6% (score 5). CONCLUSION: Given the good discriminative performance, calibration, and the ease of calculation, the PROGRESS-CTO perforation score may facilitate assessment of the risk of perforation in patients undergoing CTO PCI.

Minimalistic hybrid approach for the percutaneous treatment of chronic coronary total occlusions: An in-depth analysis of the whole algorithm.

INTRODUCTION: The minimalistic hybrid approach (MHA) is an algorithm to perform chronic total occlusion (CTO) percutaneous coronary intervention (PCI). The current study aims to evaluate the distribution of patients among the five different treatment strategies, the different techniques used in each strategy, the overall procedural success, and the safety of the MHA algorithm. METHODS: Data from a consecutive series of patients with a CTO who underwent elective PCI between February 2019 and July 2021 were prospectively collected and retrospectively analyzed. RESULTS: One hundred and forty-three CTOPCI in 135 patients were approached according to the MHA algorithm: 134 CTO (93.7%) were successfully recanalized and 9 procedures failed. About half of the procedures (48.3%) were approached using strategy A: antegrade "blind wiring" with contralateral retrograde options, making this the most popular strategy. A total of 89 procedures (62.2%) were completed with a single guiding catheter; in 86 (96.6%) a forearm approach was used. The remaining 54 cases were performed with dual access; in the majority of these patients (90.7%), a bilateral forearm approach was used. The only reason to use the femoral access was inadequate forearm access. One hundred and fifty-four out of 197 (78.2%) access sites were 6 French sheaths. CONCLUSION: MHA is a stepwise approach focused on the forearm approach to reduce the number of access sites and catheter size used in CTOPCI while maintaining proficiency and safety. Operators should be warned that this approach should be adopted only by experienced CTO operators who master all the strategies of the classic hybrid algorithm and the forearm approach.

Device entrapment during percutaneous coronary intervention.

INTRODUCTION: Device entrapment is a life-threatening complication during percutaneous coronary intervention (PCI). However, the success for its management is predominantly based on operator experience with limited available guidance in the published literature. METHODS: A systematic review was performed on December 2021; we searched PubMed for articles on device entrapment during PCI. In addition, backward snowballing (i.e., review of references from identified articles and pertinent reviews) was employed. RESULTS: A total of 4209 articles were retrieved, of which 150 studies were included in the synthesis of the data. A methodical algorithmic approach to prevention and management of device entrapment can help to optimize outcomes. The recommended sequence of steps are as follows: (a) pulling, (b) trapping, (c) snaring, (d) plaque modification, (e) telescoping, and (f) surgery. CONCLUSIONS: In-depth knowledge of the techniques and necessary tools can help optimize the likelihood of successful equipment retrieval and minimization of complications.

Clinical outcomes after permanent polymer or polymer-free stent implantation in patients with diabetes mellitus: The ReCre8 diabetes substudy.

OBJECTIVES: The purpose of this analysis was to compare target-lesion failure (TLF) of a permanent polymer zotarolimus-eluting stent (PP-ZES) versus a polymer-free amphilimus-eluting stent (PF-AES) in diabetics. BACKGROUND: The improvement of outcomes with new-generation drug-eluting stent as seen in the general population is less pronounced among diabetics. The PF-AES introduces an elution-technology with potential enhanced performance in diabetics. METHODS: In this subanalysis of the ReCre8 trial, patients were randomized to either a PP-ZES or PF-AES after stratification for diabetes and troponin status. The primary device-oriented endpoint was TLF, a composite of cardiac death, target-vessel myocardial infarction and target-lesion revascularization. RESULTS: In the ReCre8 trial, 304 (20%) patients were diabetic and 96 (6%) had insulin-dependent diabetes mellitus. There was no statistically significant difference between the two study arms regarding the primary endpoint (PP-ZES 7.2% vs. PF-AES 4.0%; p = .21), although the composite of net adverse clinical events was higher in the PP-ZES arm (15.7 vs. 8.0%; p = .035). Stent thrombosis was low in both groups with no cases in the PP-ZES arm and 1 case in the PF-AES arm (p = .32). Regarding insulin-treated diabetics, TLF was higher in the PP-ZES arm (14.9 vs. 2.1%; p = .022). CONCLUSIONS: Diabetics could potentially benefit from a dedicated stent, releasing sirolimus with a lipophilic carrier (amphilimus-formulation). Future trials should confirm the potential benefit of a PF-AES in this population.

Efficacy of coronary sinus Reducer in patients with refractory angina and diabetes mellitus.

Coronary sinus Reducer (CSR) implantation is currently recommended to relieve angina in patients with refractory symptoms despite optimal medical therapy and maximally achievable revascularization. The impact of diabetes mellitus on outcome after CSR implantation is at present unknown. We aimed to explore the impact of CSR in refractory angina patients with diabetes mellitus. Data from consecutive patients undergoing CSR implantation at four different centres between 2014 and 2018 were included. Patients were divided according to the presence or absence of diabetes mellitus. Primary objective of this analysis was to evaluate the clinical response to CSR implantation defined as an improvement of ≥ 1 classes of the Canadian Cardiovascular Society (CCS) Classification. A total of 219 patients were included, 116 (53%) of whom had diabetes mellitus. The median age of the population was 69 years and 167 patients (76%) were male. There were no significant differences between groups of patients with and without diabetes mellitus with respect to CCS class at baseline (p value = 0.32) and at follow-up (p = 0.75). Over a median follow-up of 393 [224-1004] days, 84 (72%) of the patients with diabetes mellitus met the primary outcome, similarly to those without diabetes mellitus (p = 0.28). Fifty-three patients (24%) did not have an improvement in CCS class and no one experienced worsening of angina. CSR implantation was equally effective in improving angina symptoms among patients with refractory angina and diabetes mellitus compared to patients without diabetes mellitus.

A prospective evaluation of a redefined version of the "minimalistic hybrid approach" algorithm for percutaneous coronary chronic total occlusion revascularization.

OBJECTIVES: Aim of this study is to prospectively assess the feasibility of the "Minimalistic Hybrid Approach" (MHA) algorithm for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: We recently described the MHA, with focus on the classic hybrid strategies (antegrade wire escalation [AWE] or retrograde wire escalation [RWE], antegrade dissection-re-entry [ADR] or retrograde dissection-re-entry [RDR]), and also on access site (favoring "wrist" approach: radial, ulnar, and distal radial), introducer French size (favoring 6 French catheters) and nonroutine initial use of dual injection. METHODS: The MHA was prospectively attempted in 56 consecutive CTO PCI in 54 patients. Technical success was defined as the achievement of TIMI 3 antegrade flow with residual stenosis <30%, procedural success was defined as technical success without in-hospital major adverse cardiovascular events. RESULTS: Mean Japanese-CTO (J-CTO) score was 2.04 ± 0.95(J-CTO score ≥ 3 in 30.4%). The lesion-based technical and procedural success were 94.6%(53/56:three failures, two in the same patient) and 91.1%(51/56:three failures, one tamponade requiring pericardiocentesis and one periprocedural infarction), the patient-based successes were: technical 98.1%(53/54) and procedural 94.4%(51/54). In 34 procedures (60.7%), the approach was single catheter (always trans-wrist besides one femoral). Out of the 22(39.3%) lesions approached with dual catheters, one was bi-femoral, the rest was bi-wrist. In 29 cases (51.8%) AWE represented the successful technique, ADR in 5(8.9%) and retrograde in 19(33.9%); 3(5.4%) were failures. CONCLUSIONS: The current study shows that the MHA algorithm is feasible in almost every CTO lesion and it can lead to extremely successful results once applied by operators well acquainted with the wrist approach and with established experience using the full spectrum of the hybrid algorithm techniques.

Impact of prior coronary artery bypass grafting in patients undergoing chronic total occlusion-percutaneous coronary intervention: Procedural and clinical outcomes from the REgistry of Crossboss and Hybrid procedures in FrAnce, the NetheRlands, BelGium, and UnitEd Kingdom (RECHARGE).

AIM: Chronic total occlusions (CTO) in patients with history of coronary artery bypass graft (CABG) show more advanced and complex atherosclerotic pathology. Aim of our study is to compare outcomes in patients undergoing CTO percutaneous coronary intervention (PCI) with previous CABG versus those without in the REgistry of Crossboss and Hybrid procedures in FrAnce the NetheRlands, BelGium and UnitEd Kingdom (RECHARGE). METHODS & RESULTS: The RECHARGE cohort (1,252 patients) was divided in two groups according to the presence of previous CABG (217) or not. We also focused, in the post-CABG group, on a comparison between CTO in previously grafted vessels versus non-grafted vessels. The CTO complexity scores were higher and the success rate (71.9% vs. 88.7%, p < .001) was lower in the CABG group, this difference was driven by higher failure rates in high-complexity-score CTO. The rate of in-hospital complications was similar. In the post-CABG group, the procedural success of CTO located in previously grafted vessels versus those in vessels not previously grafted, was comparably suboptimal (73.1% vs. 68%, p = .47). CONCLUSION: Patients undergoing CTO PCI with prior CABG have a higher prevalence of comorbidities and more complex lesion characteristics. In the post-CABG population the success rate was significantly lower, particularly in high CTO complexity scores, though complication rates were comparable. In the post-CABG population, the CTO success rate was independent of the presence of a previous graft on the CTO vessel.

iFR uncovers profound but mostly reversible ischemia in CTOs and helps to optimize PCI results.

OBJECTIVES: The study aimed to demonstrate through instant wave-free ratio (iFR) measurements that myocardium distal to a chronic total occlusion (CTO) is ischemic, that ischemia is reversible by PCI, and that iFR assessment after PCI can be used to optimize PCI results. BACKGROUND: The greatest benefit of revascularization is found in patients with low fractional flow reserve. In patients with CTOs, iFR measurement may be more appropriate to evaluate ischemia as it does not require maximal microvascular vasodilation, which may be hampered by microvascular dysfunction. METHODS: The iFR was measured in 81 CTO patients, both pre- and post-PCI in 63 patients, and only post-PCI in the following 18 patients. A pressure wire pullback was performed post-PCI if iFR ≤0.89. RESULTS: The first 63 patients all had significant ischemia distal to the CTO with a median iFR of 0.33 [0.22; 0.44], improving significantly post-PCI to a median iFR of 0.93 [0.89;0.96] (p < .001). In the complete cohort, the median iFR post-PCI was 0.93 [0.86;0.96] but still ≤0.89 in 23 patients (30%). 12 of these patients had further PCI optimization because of a residual focal pressure gradient on pullback, after which only two had a final iFR ≤0.89. CONCLUSIONS: In CTO patients with an indication for PCI, iFR consistently demonstrated profound myocardial ischemia. Successful PCI immediately relieved ischemia in 70% of patients. In the remaining 30% of cases, a manual iFR pullback proved helpful in guiding further optimization of the PCI result.

Coronary sinus anatomical features: Description and procedural implications during coronary sinus Reducer implantation.

OBJECTIVES: We hypothesized that some coronary sinus (CS) anatomies allow a more straightforward CS Reducer (CSR) implantation. BACKGROUND: Recent decades have seen a rise in patients with chronic angina. When complete revascularization and maximal medical therapy fail to reduce symptoms, CSR has become a new therapeutic option. METHODS: We identified a classical C-shape-a near horizontal course of the proximal portion of a circular CS-in a retrospective analysis of 47 CSR implantations and compared the procedural time, fluoroscopic time, contrast use, presence of valves or bifurcations and procedural complications with the non-C-shape CS anatomy. RESULTS: We found a significant difference in procedural (20.0 [19.0-24.7] min vs. 24.5 [20.7-51.0] min; p = .028 and fluoroscopic time (9.5 [7.5-14.5] min vs. 11.0 [7.9-30.0] min; p = .016). There was no significant difference in contrast use. The presence of bifurcations or valves along the CS course did not influence the procedural timings. CONCLUSION: This study is the first systematic evaluation of CS anatomy and its procedural implications. We identified a favorable C-shape anatomy which allows for a more straightforward implantation. Operators should be aware of the different implications of CS anatomy, their influence on guiding catheter stability and overall procedure complexity.

Predictors and outcomes of procedural failure of percutaneous coronary intervention of a chronic total occlusion-A subanalysis of the EXPLORE trial.

OBJECTIVE: To evaluate predictors of procedural success of percutaneous coronary intervention (PCI) of chronic total coronary occlusions (CTOs) in a non-infarct-related artery following ST-segment elevation myocardial infarction (STEMI), and demonstrate the effect on left ventricular functionality (LVF), infarct size (IS), and pro-arrhythmic electrocardiogram (ECG) parameters. BACKGROUND: Predictors of unsuccessful revascularization of a CTO are numerous, although following STEMI, these are lacking. Besides, effects of failed CTO PCI (FPCI) on the myocardium are unknown. METHODS: This is a subanalysis of the EXPLORE trial, in which 302 STEMI patients with a concurrent CTO were randomized to CTO PCI (n = 147) or no-CTO PCI (NPCI, n = 154). For the purpose of this subanalysis, we divided patients into successful CTO PCI (SPCI, n = 106), FPCI (n = 41), and NPCI (n = 154) groups. Cardiac magnetic resonance imaging and angiographic data were derived from the EXPLORE database, combined with ECG parameters. To gain more insight, all outcomes were compared with patients that did not undergo CTO PCI. RESULTS: In multivariate regression, only CTO lesion length >20 mm was an independent predictor of procedural failure (OR 3.31 [1.49-7.39]). No significant differences in median left ventricular ejection fraction, left ventricular end-diastolic volume, IS, and the pro-arrhythmic ECG parameters such as QT-dispersion, QTc-time, and TpTe-intervals were seen between the SPCI and FPCI groups at 4 months follow-up. CONCLUSION: This subanalysis of the EXPLORE trial has demonstrated that a CTO lesion length >20 mm is an independent predictor of CTO PCI failure, whereas procedural failure did not lead to any adverse effects on LVF nor pro-arrhythmic ECG parameters.

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.

Coronary Sinus Reducer for the Treatment of Chronic Refractory Angina: Will This Challenge the Treatment of Coronary Chronic Total Occlusions?

PURPOSE OF REVIEW: The prevalence of angina despite optimal medical therapy is high among patients with coronary chronic total occlusions. Despite advancements in techniques and operator's experience, percutaneous revascularization of coronary chronic total occlusions is still associated with a not negligible risk of failures and complications. The Coronary Sinus Reducer, a new device developed to improve angina, has shown promising results in terms of efficacy and safety in patients with refractory symptoms. The aim of this review is to summarize the evidence so far available and to guide clinicians in the selection of patients with chronic total occlusions that could benefit more from Coronary Sinus Reducer implantation. RECENT FINDINGS: A recently published study suggests a clear value of this device in patients with chronic total occlusions. This is likely to be related to the presence of a well-developed collateral circulation. A careful evaluation of risks and benefits of both myocardial revascularization and Coronary Sinus Reducer implantation should be done in all the cases in order to better define the optimal strategy for the patient. The Coronary Sinus Reducer implantation has a rationale in patients with chronic total occlusion as an alternative or additional therapy to myocardial revascularization.

Randomized All-Comers Evaluation of a Permanent Polymer Zotarolimus-Eluting Stent Versus a Polymer-Free Amphilimus-Eluting Stent.

BACKGROUND: Polymer-free amphilimus-eluting stents (PF-AES) represent a novel elution technology in the current era of drug-eluting stents. The clinical safety and efficacy of PF-AES as compared with latest-generation permanent-polymer zotarolimus-eluting stents (PP-ZES) have not yet been investigated in a large randomized trial. METHODS: In this physician-initiated, prospective, multicenter, randomized, noninferiority trial, an all-comers population requiring percutaneous coronary intervention was enrolled across 3 European sites. Randomization (1:1 ratio) to PP-ZES or PF-AES was performed after stratification for troponin status and diabetes mellitus. In both treatment arms, troponin-positive patients were planned for 12-month dual antiplatelet therapy, whereas troponin-negative patients were planned for 1-month dual antiplatelet therapy. Outcome assessors were blinded to the allocated treatment. The device-oriented primary end point of target-lesion failure was defined as cardiac death, target-vessel myocardial infarction, or target-lesion revascularization at 12-months as analyzed by modified intention-to-treat (80% power, and a 3.5% noninferiority margin). RESULTS: In total, 1502 patients were randomized and 1491 treated with the assigned stent and available for follow-up. The primary end point occurred in 42 (5.6%) of the 744 patients receiving PP-ZES versus 46 (6.2%) of the 747 patients receiving PF-AES. PF-AES were clinically noninferior to PP-ZES (risk difference, 0.5%; upper limit 1-sided 95% confidence interval, 2.6%; Pnoninferiority=0.0086). Cardiac death occurred in 10 (1.3%) versus 10 patients (1.3%; P value for difference, 1.00), target-vessel myocardial infarction occurred in 18 (2.4%) versus 17 patients (2.3%; P value for difference, 0.87), and target-lesion revascularization occurred in 22 (2.9%) versus 20 patients (2.6%; P value for difference, 0.75) for PF-AES as compared with PP-ZES. Overall, definite or probable stent thrombosis occurred in 1.0%. CONCLUSIONS: PF-AES were noninferior to PP-ZES regarding target-lesion failure at 12 months. Findings regarding the secondary end point and prespecified subgroups were generally consistent with that of the primary end point. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02328898.

A "minimalistic hybrid algorithm" in coronary chronic total occlusion revascularization: Procedural and clinical outcomes.

BACKGROUND: Percutaneous recanalization of coronary chronic total occlusions (CTOs) traditionally relies on the use of dual-access and large bore catheters, with trans-femoral approach adoption in most cases. OBJECTIVES: Aim of this manuscript is to describe the outcomes of an alternative hybrid algorithm, called "Minimalistic Hybrid Algorithm," which has the purpose to minimize the use of double access, large bore catheters, and femoral approach in order to minimize the risk of vascular complications and patient's discomfort, without compromising efficacy. METHODS: In this single-center registry, a "minimalistic" approach was attempted in consecutive patients undergoing CTO PCI between March 2016 and October 2017. Data regarding the applicability of this algorithm and the related procedural success rates were collected, together with common demographic and angiographic characteristics. RESULTS: Of the 100 CTO PCI performed in the study period, 91(91%) were successfully approached according to the novel algorithm. Mean J-CTO score of all minimalistic procedures was 1.9 ± 1.2, with 31(34%) patients presenting with J-CTO score ≥3. In 52 procedures, the approach consisted of single-catheter access, 49(94.2%) of which were trans-radial. Out of the 39 patients approached with dual-catheters, 26(69.2%) were biradial, and 8(21%) radial-femoral. Procedural success in patients approached with the minimalistic algorithm was 89%, in line with the results of large-multicenter experiences nowadays available. CONCLUSIONS: Our results show that an alternative algorithm limiting the routine use of large bore catheters and trans-femoral approach is feasible in the clinical practice and yields good procedural outcomes.

Conventional vascular access site approach versus fully trans-wrist approach for chronic total occlusion percutaneous coronary intervention: a multicenter registry.

OBJECTIVES: To evaluate the incidence of vascular complication and major bleeding in patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) with a fully trans-wrist access (TWA) approach versus a conventional approach based on trans-femoral access (TFA). BACKGROUND: TFA is the preferred vascular access in CTO PCI, but it has been associated with a non-negligible risk of complications. METHODS: This retrospective registry included all patients undergoing CTO PCI at five institutions between July 2011 and October 2018. Patients were divided into two groups: Conventional (patients treated with at least one TFA) and Fully TWA (subjects exclusively treated with one or two TWA). The primary safety endpoint was a composite of vascular complications and major bleeding. The primary efficacy endpoint was procedural success. RESULTS: We included 1,900 patients (Conventional n = 1,496 and Fully TWA n = 404). Conventional patients showed higher occlusion complexity (J-CTO score 2.1 ± 1.2 vs. 1.5 ± 1.1, p < .001). Procedural success showed no significant difference between both groups (85.7 vs. 83.0%, p = .17). The primary safety endpoint occurred more frequently in the Conventional group (10.3 vs. 4.5%, p < .001), driven by vascular complications (9.4 vs. 3.7%, p < .001). On multivariate analysis, not using a Fully TWA approach was an independent predictor of the study endpoint, after adjusting for age, sex, diabetes, body mass index, chronic kidney disease, prior coronary artery bypass graft, and J-CTO score. CONCLUSIONS: Embracing a Fully TWA approach for CTO PCI might be associated with lower incidence of a composite endpoint of vascular complications and major bleeding, compared with a Conventional approach.