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Published on: February 18, 2020
The First-in-Man Technique of Drug Eluting and Perfusion Therapy for Left Main Coronary Artery Disease
Takayuki Warisawa1, Yoshiki Kawai1, Takuya Matsumoto1
1Department of Cardiology, NTT Medical Center Tokyo, Tokyo, Japan.
Insights
A novel kissing balloon technique (W-KBT) using a perfusion balloon and drug-coated balloon proved safe and feasible for treating left main disease (LMD) with ostial LCx lesions. This approach allowed prolonged inflation without hemodynamic instability in a pilot study.
Area of Science:
- Interventional Cardiology
- Cardiovascular Disease
- Medical Device Technology
Background:
- Percutaneous coronary intervention (PCI) for left main disease (LMD) with ostial left circumflex artery (LCx) lesions presents challenges.
- Concerns exist regarding crossover-stenting from the left main trunk (LMT) to the left anterior descending artery (LAD) using drug-coated balloons (DCB).
- Isolated DCB treatment may cause carina shift, while conventional kissing balloon techniques (C-KBT) risk prolonged LMT occlusion and hemodynamic instability.
Purpose of the Study:
- To evaluate the safety and feasibility of a novel double-effect kissing balloon technique (W-KBT).
- W-KBT utilizes a perfusion balloon (PB) for LMT-LAD and a DCB for LMT-LCx.
- The technique aims to allow prolonged inflation while maintaining coronary perfusion during PCI for LMD.
Main Methods:
- A single-center prospective study enrolled consecutive patients with de-novo LMD and ostial LCx lesions.
- Patients underwent crossover-stenting from LMT to LAD, followed by proximal optimization technique and C-KBT.
- The novel W-KBT was performed after confirming optimal PCI, using a 7 Fr guiding catheter via a transradial approach.
Main Results:
- Procedural success was achieved in all 12 enrolled patients (mean age 73.8 years; 91.7% men).
- W-KBT inflation was maintained for 60 seconds without hemodynamic instability (mean BP change -13.7 mmHg, mean HR change -3.4 bpm).
- No ST-elevation or need for inotropes/mechanical support was observed; ST changes occurred in 50% but resolved quickly.
Conclusions:
- The first-in-man W-KBT demonstrated safety and feasibility in this pilot study.
- The technique allows adequate drug delivery to the ostial LCx lesion.
- W-KBT offers a promising alternative for complex PCI in left main coronary artery disease.
Background:
Treating ostial left circumflex artery (LCx) lesions in percutaneous coronary intervention (PCI) for left main disease (LMD) remains a challenge. Despite recent recommendations for the use of drug-coated balloon (DCB) in this lesion, there are concerns about crossover-stenting from the left main trunk (LMT) to the left anterior descending artery (LAD). Specifically, isolated DCB treatment for the ostial LCx lesion may induce carina shift, while conventional kissing balloon technique (C-KBT) with a standard balloon and a DCB may prolong LMT occlusion, leading to hemodynamic instability.
Objectives:
This study aimed to evaluate the safety and feasibility of a novel double-effect KBT (W-KBT) using a perfusion balloon (PB) for the LMT-LAD and a DCB for the LMT-LCx, allowing prolonged inflation while maintaining coronary perfusion.
Methods:
This single-center prospective study enrolled consecutive patients with de-novo LMD and ostial LCx lesions, requiring crossover-stenting from the LMT to the LAD followed by proximal optimization technique and C-KBT. After confirming optimal PCI, W-KBT was performed.
Results:
Among 12 enrolled patients (mean age 73.8 ± 7.2, 91.7% men), procedural success, defined as device delivery and W-KBT time ≥ 30 s, was achieved in all cases via the transradial approach. W-KBT inflation-time was consistently 60 s; ST changes occurred in 50% (no ST-elevation); mean ST-change time was 41.2 ± 7.1 s; mean delta-blood pressure was -13.7 ± 11.4 mmHg; mean delta-heart rate was -3.4 ± 5.9 bpm; and no inotropes or mechanical cardiac support were needed.
Conclusion:
Within the limited sample size of this pilot study, the safety and feasibility of the first-in-man W-KBT were suggested.
Summary:
This pilot study evaluated the safety and feasibility of a novel double-effect kissing balloon technique (W-KBT) in percutaneous coronary intervention for left main coronary artery disease, realized by the combined use of a perfusion balloon and a drug-coated balloon. Among 12 patients, device delivery was successful via a transradial approach using a 7 Fr guiding catheter. The W-KBT was maintained for 60 s without hemodynamic instability, providing adequate drug application to the ostial left circumflex artery lesion. Furthermore, no ST-elevation or periprocedural myocardial infarction was observed, highlighting the safety and feasibility of this technique.
