Georgios Sianos1*, MD, PhD, FESC; Gerald S. Werner2, MD, PhD, FESC, FACC, FSCI; Alfredo R. Galassi3, MD, FESC, FACC, FSCAI; Michail I. Papafaklis4, MD, PhD; Javier Escaned5, MD, PhD, FESC; David Hildick-Smith6, MD, FESC; Evald Hoj Christiansen7, MD, PhD; Anthony Gershlick8, MD, FRCP, FESC; Mauro Carlino9, MD, FESC; Angelos Karlas1, MD; Nikolaos V. Konstantinidis1, MD; Salvatore D. Tomasello3, MD; Carlo Di Mario10, MD, PhD, FRCP, FESC; Nicolaus Reifart11, MD, PhD, FESC for the EuroCTO Club

Recanalisation of chronic total coronary occlusions: 2012 consensus document from the EuroCTO club.

AIMS: In comparison with non-occlusive lesions, percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) represents a greater challenge for the interventionalist, due to lower procedural success rates, relatively higher incidence of procedural complications and the increased rate of restenosis. The European Registry of Chronic Total Occlusion (ERCTO) was created with the goal of evaluating the real impact of CTO PCI in the European context, trying to analyse the rates of procedural success, technical information from the CTO procedures and patient outcome. METHODS AND RESULTS: Data collection was carried out in 16 centres across Europe, starting from the beginning of January 2008. In two years of activity, a total of 1,914 patients with 1,983 CTO lesions were consecutively enrolled in the registry. Overall procedural success was achieved in 1,607 lesions (82.9%); anterograde procedures obtained higher procedural success of retrograde ones (83.2% versus 64.5%, p<0.001). Coronary perforation occurred more frequently in patients who underwent retrograde approach (4.7% versus 2.1%, p=0.04). Although no differences were observed in terms of 30-day major adverse cardiac events between anterograde and retrograde treated patients, a trend toward higher periprocedural non-Q-wave myocardial infarction was found in patients in which the retrograde approach was attempted (2.1% versus 1% p=0.08). Moreover, retrograde approach was related with longer procedural and fluoroscopy times (156.9±62.5 min vs. 98.2±52.8 min and 73.3±59.9 min vs. 38.2±43.9 min respectively, p<0.001) and higher contrast load administration (402±161 cc vs. 302±184 cc, p<0.001). CONCLUSIONS: The first report of the ERCTO registry by the EuroCTO club shows a high procedural success rate obtained by expert European operators in a "real-world" consecutive series of patients, comparable with those reported by Japanese registries. The rate of observed procedural adverse events was low and similar to the non-CTO PCI series. In this registry, retrograde procedures were associated with extended fluoroscopy exposure and procedural time, increased contrast load administration as well as a higher incidence of coronary perforations. Such outcomes should become the standard of care that all centres undertaking CTO PCI should aspire to.

In-hospital outcomes of percutaneous coronary intervention in patients with chronic total occlusion: insights from the ERCTO (European Registry of Chronic Total Occlusion) registry.

Objectives This study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial. Background Women are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear. Methods Women undergoing cardiac catheterization or PCI were randomized to radial or femoral arterial access. Data from the CathPCI Registry and trial-specific data were merged into a final study database. The primary efficacy endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding or vascular complications requiring intervention. The primary feasibility endpoint was access site crossover. The primary analysis cohort was the subgroup undergoing PCI; sensitivity analyses were conducted in the total randomized population. Results The trial was stopped early for a lower than expected event rate. A total of 1,787 women (691 undergoing PCI) were randomized at 60 sites. There was no significant difference in the primary efficacy endpoint between radial or femoral access among women undergoing PCI (radial 1.2% vs. 2.9% femoral, odds ratio [OR]: 0.39; 95% confidence interval [CI]: 0.12 to 1.27); among women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding and vascular complications (0.6% vs. 1.7%; OR: 0.32; 95% CI: 0.12 to 0.90). Access site crossover was significantly higher among women assigned to radial access (PCI cohort: 6.1% vs. 1.7%; OR: 3.65; 95% CI: 1.45 to 9.17); total randomized cohort: (6.7% vs. 1.9%; OR: 3.70; 95% CI: 2.14 to 6.40). More women preferred radial access. Conclusions In this pragmatic trial, which was terminated early, the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI. Access site crossover occurred more often in women assigned to radial access. (SAFE-PCI for Women; NCT01406236 )

A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial.

Intra-aortic Balloon Counterpulsation and Infarct Size in Patients with Acute Anterior Myocardial Infarction without Shock: The CRISP AMI Randomized Trial

Currently, successful treatment of chronic total occlusion (CTO) seems markedly improved, due to several new techniques and dedicated device developments. However, this improved success rate is often limited to procedures performed by skilled, highly experienced operators. To improve the overall success rate of percutaneous coronary intervention of CTO from a worldwide perspective, a deeper understanding of CTO histopathology might offer insights into the development of new techniques and procedural strategies. In this review, CTO histopathology and wire techniques are discussed on the basis of the fundamental concepts of antegrade and retrograde approaches. Although details pertaining to wire manipulation are very difficult to explain objectively, we tried to describe this as best as possible in this article. Finally, a systematic review of the current standard CTO strategy is provided. Hopefully, this article will enhance the understanding of this complex procedure and, consequently, promote safe and effective CTO-percutaneous coronary intervention for patients who present with this challenging lesion subset.

Fundamental Wire Technique and Current Standard Strategy of Percutaneous Intervention for Chronic Total Occlusion With Histopathological Insights

While primary percutaneous coronary intervention (PCI) has significantly contributed to improve the mortality in patients with ST segment elevation myocardial infarction even in cardiogenic shock, primary PCI is a standard of care in most of Japanese institutions. Whereas there are high numbers of available facilities providing primary PCI in Japan, there are no clear guidelines focusing on procedural aspect of the standardized care. Whilst updated guidelines for the management of acute myocardial infarction were recently published by European Society of Cardiology, the following major changes are indicated; (1) radial access and drug-eluting stent over bare metal stent were recommended as Class I indication, and (2) complete revascularization before hospital discharge (either immediate or staged) is now considered as Class IIa recommendation. Although the primary PCI is consistently recommended in recent and previous guidelines, the device lag from Europe, the frequent usage of coronary imaging modalities in Japan, and the difference in available medical therapy or mechanical support may prevent direct application of European guidelines to Japanese population. The Task Force on Primary Percutaneous Coronary Intervention of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) has now proposed the expert consensus document for the management of acute myocardial infarction focusing on procedural aspect of primary PCI.

/pdf/cvit-expert-consensus-document-on-primary-percutaneous-1g1nz3pd96.pdf

CVIT expert consensus document on primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) in 2018

Objectives: The aim of this study was to evaluate the safety and effectiveness of a 0.010-inch guidewire and a balloon catheter for treatment of chronic total occlusion (CTO). Background: Pathological studies have shown that 60–70% of CTO lesions have microchannels of sizes equal to or less than 0.010 inch. Methods: The PIKACHU registry is a prospective, multicenter registry study. A 0.010-inch guidewire had to be used as the first guidewire to attempt to pass the CTO lesion. The primary endpoint was device success using a 0.010 system. Results: A total of 141 patients with 141 lesions were enrolled. The median duration of occlusion was 9 months (range 3–156). Average guiding catheter size was 5.8 ± 0.7 Fr. and TRI was 76.6 %. CTOs were mostly between 10–20 mm long, observed in 53 occlusions. There were 107 lesions (75.9%) with bending of more than 45 degrees. Calcification was seen in 91 lesions (64.5%). A 0.010-inch guidewire was successfully passed through in 97 of 141 lesions (68.8%). A 0.010-inch guidewire compatible balloon catheter was passed in 87 of the 97 lesions (88.7%) and final PCI success was achieved in all the cases. The overall clinical success rate was 87.9% (124/141). No MACE or bleeding complications were observed. Conclusion: The PIKACHU registry data suggest that the 0.010-inch system is safe and practicable for treatment of CTO lesions. © 2010 Wiley-Liss, Inc.

A prospective multicenter registry of 0.010-inch guidewire and compatible system for chronic total occlusion: the PIKACHU registry.

Objective:

To evaluate the safety and feasibility of a new 0.010-inch guidewire and a specialized balloon catheter for the 0.010-inch guidewire in routine percutaneous coronary intervention (PCI).



Background:

Several reports have shown that a new 0.010-inch system is effective for specific situations where reduction of catheter size may be necessary. However, the safety of this system in routine PCI is unknown.



Methods:

The IKATEN registry is a prospective, multicenter, nonrandomized registry study. Patients who underwent elective PCI with a 0.010-inch guidewire and its associated balloon catheter as primary devices were enrolled. The coprimary endpoints were clinical success and device success rates. The secondary endpoints were major adverse cardiac events (MACE) and bleeding complications.



Results:

A total of 133 patients with 148 lesions were enrolled. The majority were male (75.3%), and mean age was 68 ± 10 years. Type B2/C lesions comprised 60% of the lesions, prevalence of chronic total occlusion (CTO) was 16.9%, and bifurcation lesions were found in 22.3% of patients. A transradial approach was used in 79.7% of patients, and the average guiding catheter size was 5.1 ± 0.4 Fr. Clinical success rate was 99.2%, and device success rate was 99.3%. Device failure occurred only in one case of chronic total occlusion because of unsuccessful guidewire passage. No MACE or bleeding complications were reported except for a small hematoma at the puncture site in one patient. Stent delivery success rate on 0.010-inch guidewire was 93.9% because of failure of stent balloon to pass eight lesions.



Conclusion:

The IKATEN registry data suggest that the 0.010-inch system is safe and its use is feasible in routine PCI including bifurcation and CTO lesions. © 2009 Wiley-Liss, Inc.

Yoshiaki Katahira

Papers

CVIT expert consensus document on primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) in 2018

A prospective multicenter registry of 0.010-inch guidewire and compatible system for chronic total occlusion: the PIKACHU registry.

A new 0.010-inch guidewire and compatible balloon catheter system: the IKATEN registry.