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. 2021 Oct 25;11(5):544-554.
eCollection 2021.

Perforated balloon technique mediated intracoronary delivery of nicorandil to treat coronary no-reflow phenomenon: a novel pharmacological solution to precarious situation

Santosh K Sinha  1 , Prakash Kumar  2 , Awadesh K Sharma  1 , Mahmodullah Razi  1 , Umeshwar Pandey  1 , Mohit Sachan  1 , Praveen Shukla  1 , Puneet Aggarwal  3 , Mukesh J Jha  4 , Ramesh Thakur  1 , Vinay Krishna  1
Affiliations

Perforated balloon technique mediated intracoronary delivery of nicorandil to treat coronary no-reflow phenomenon: a novel pharmacological solution to precarious situation

Santosh K Sinha et al. Am J Cardiovasc Dis. .

Abstract

Background: Coronary no-reflow (NRF) following percutaneous coronary intervention (PCI) is infrequent but one of the most dreaded complication which results from impaired flow of microvascular bed. It is associated with adverse outcome if flow is not restored. Objective of this study was to find safety, effectiveness and outcome of intracoronary nikorandil (IC) administered using perforated balloon technique (PBT) to reverse NRF.

Method: 2-4 mg of nicorandil was diluted with 5 ml of normal saline and administered using PBT over 5-minute. Its effectiveness was evaluated after 10 minute qualitatively using TIMI flow and quantitatively corrected TIMI frame count (cTFC) method.

Result: Study comprised of 84 patients (out of 1789 patients undergoing PCI between January 2019 and February 2020). Their mean age was 57.8±17.9 years. Following PBT, TIMI III flow was successfully normalized in 71 subjects (84.5%), ten (12%) patients had TIMI II flow and it was not successful in three (3.5%) patients. TIMI flow grade got bettered from 1.03 to 2.58 and cTIMI frame count regressed from 52.9±11 to 16.5±5 (P < 0.001). PBT was well tolerated except short lived drop in blood pressure (n=10; 11.9%).

Conclusion: This study, for the first time to the best our knowledge, demonstrated that PBT mediated intracoronary administration of nikorandil distally was rapid, safe, and efficacious method to deal with NRF.

Keywords: Perforated balloon technique; TIMI flow; TIMI frame count; nicorandil; no-reflow; percutaneous coronary intervention.

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Conflict of interest statement

None.

Figures

Figure 1
Figure 1
A semicompliant balloon (2.5×15 mm) was chosen for PBT (A); In-vitro inflation of the balloon catheter was performed at 10 atm pressure using the inflation device (B).
Figure 2
Figure 2
Six to ten punctures in different areas of inflated balloon segment were performed using a 26 gauze needle (A); The saline was allowed to ooze from the perforated segments to remove all possible micro-bubbles (B, C).
Figure 3
Figure 3
Changes of TIMI flow grading at baseline, NRF after deployment of stent and reversal of no reflow following PBT which led improvement in TIMI flow.
Figure 4
Figure 4
Changes of TIMI flow grading at baseline, after deployment of stent and after PBT. There was significant improvement in TIMI flow following PBT (P < 0.001) as TIMI flow was impaired in all patients prior to treatment.
Figure 5
Figure 5
cTFC at the time of no-reflow and after PBT showing significant reduction in TIMI frame count (P < 0.001).
Figure 6
Figure 6
Angiogram of left system showing diffuse disease of left anterior descending artery (A); After predilatation, it was stented using 3×33 mm Xience Prime everolimus eluting stent (Abott Vascular; USA) at 12 atm pressure proximally (B) and 2.75×33 mm Xience Prime distally (C).
Figure 7
Figure 7
No reflow of LAD with no filling of contrast from mid segment of stent (A, B).
Figure 8
Figure 8
Nicorandil was administered using PBT from distal most segment to proximal segment of LAD (A, B).
Figure 9
Figure 9
Nicorandil was administered using PBT from distal most segment to proximal segment of LAD (A-C).
Figure 10
Figure 10
Reversal of no reflow after Nicorandil administration with TIMI 3 flow in LAD.
See this image and copyright information in PMC

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