From January 2008 until December 2019, a total number of 810 patients underwent CTO-PCI performed by a single highly experienced operator. In 598 cases, contralateral injections were required to visualize the vessel distal to the occlusion, and in 587/598, the parallel sheath technique was applied.
In our study, we are analyzing a subgroup of 90 consecutive patients in which laboratory controls were systematically scheduled the day after CTO-PCI.
All patients had a chronic coronary occlusion causing angina or dyspnea and proven viable myocardium assessed by echocardiography, magnetic resonance imaging, or scintigraphy.
Chronic total coronary occlusion was defined congruent with the EuroCTO club [9].
Procedural success was defined as TIMI flow 3 and a residual stenosis of 20% or less.
Major adverse cardiac events (MACE) were defined as new intra-hospital non-Q-wave and Q-wave myocardial infarction (defined as myocardial infarction by laboratory findings with or without development of new Q waves), recurrent angina requiring urgent repeat revascularization with PCI or coronary artery bypass grafting, stroke, death, pericardiocentesis, or surgical drainage of pericardial hematoma [10].
Minor bleeding was defined as any bleeding or reported large hematoma (with Hb drop < 3 g/dL) that led to a prolonged hospital stay for surveillance (BARC type 1 or 2) [11].
Major bleeding was defined as bleeding with hemoglobin drop of > 3 g/dL or requiring transfusion of any blood products (BARC 3a criteria or greater).
We assessed hemoglobin levels before and the day after the intervention as well as INR, thrombocytes, procedural time, and platelet inhibiting medication. Patients were allowed to eat and drink the day before as well as having a light breakfast the day of the procedure. To deal with potentially excessive dye consumption, intravenous saline was given the day before at a rate of 80 mL/h to all patients unless they had a severely reduced ejection fraction.
Patients were pre-loaded with acetylsalicylic acid 500 mg and Clopidogrel 600 mg or Ticagrelor 180 mg at the time of intervention unless they were already on dual antiplatelet therapy (DAPT). Oral anticoagulation (OAC) was stopped 24 h before the procedure.
All patients were considered to receive two unifemoral sheaths with one primary access for intervention and the second one for contralateral dye injection. If antegrade success was likely, 4 French sheaths were chosen. Planned or potential retrograde procedures required a sheath size of 5 French or greater.
The larger size sheath was always put in first. The dilatator and Seldinger wire were left in place to help straighten the vessel and to guide the second puncture (Fig. 1). The smaller sheath was then placed medial to the first sheath unless there was not adequate space. The needle was guided strictly parallel and close to the first sheath making sure not to puncture it (Fig. 2). In some cases, the puncture and sheath placement were confirmed fluoroscopically (Fig. 3). In patients with severe femoral calcification and difficulty to insert the first sheath, the femoral artery was visualized with dye. In two cases, the operator deemed the vessel to be too narrow for a second sheath and the parallel sheath technique was abandoned (2.2%).
All procedures followed the same protocol with 10,000 IU of unfractionated heparin given as a bolus as soon as both sheaths were successfully placed. Roughly two thirds of the bolus were given through the sheath with the bigger diameter, the remaining third into the other sheath. Activated clotting time (ACT) was checked after 45 min while with BMI above 30 kg/m2, the ACT was checked sooner. Subsequent doses of unfractionated heparin were given according to the operator’s discretion with the goal to keep the ACT > 250 s during the procedure and < 250 s at its end. After the PCI was concluded, both sheaths were pulled immediately unless the ACT was still above 250 s, or the patient’s systolic blood pressure was above 180 mmHg. Reversal of heparin was not routinely performed.
No vascular closure devices were used in this case series, all sheaths were pulled and followed by manual compression only. More recently, two Angio-Seal vascular closure devices (Terumo Interventional Systems, Somerset, NJ) were used to close both puncture sites (if > 4 French) in most cases (Figs. 4 and 5).
Baseline data including procedural information, demographics, and comorbidities were collected prospectively in a dedicated database (ERCTO registry). Written consent was obtained. The case series was approved by the institutional research and ethics committee and complied with the Declaration of Helsinki.
Data analysis was done with the open access statistical software R 3.6.1 and R-Studio. All values are represented as mean with standard deviation.