One case of the tip of Guide Wire stuck on Stent strut after the DES had been placed

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1 One case of the tip of Guide Wire stuck on Stent strut after the DES had been placed Nagasaki Medical Center, Department of Cardiology Atsuki Fukae Yuho Fukuda Noriaki Tanaka Sinichi Haruta Takashi Matsuo Koji Oku I do not have any potential conflict of interest ASIA PCR 2018 Singapore

2 Potential conflicts of interest Speaker's name : Atsuki Fukae, nagsaki Medical Center, Omura Nagasaki, Japan I do not have any potential conflict of interest

3

4 Introduction However, PCI operators have a low probability which they may encounter incidental symptoms or complications that are quite unexpected. PCI operators must resolve the unexpectedly tense troubles and complications encountered by chance with appropriate and prompt judgment and trained skill for PCI.

5 Presentation In this presentation, we report that GW stacked into the stent directly (entrapment) and experienced difficulty in stent and GW removal, pulling out from the coronary artery (Extraction).

6 Case Case presentation presentation

7 Case: 61y.o. Male. Chief Complaint: Chest pain and discomfort on effort Present illness: Even though he was aware of the epigastric discomfort several years ago, he was diagnosed with gastritis and GERD. He had been following with PPI. He acknowledged chest pain and oppressive feeling at the time of exertion and was introduced to our hospital with a diagnosis of angina pectoris Coronary risk factor : hypertension dyslipidemia smoking(10/day x 40 years) Physical findings: T T cmw W kg BP116/74mmHg HR78bpm BT BT 36.1 Heart sound :No :No murmur/ Respiratory sound : : normal No No edema in in the the limbs No No neurological findings Labo data: WBC 6500 Hb13.0 AST 24 ALT 11 CPK 217 Cr 0.6 BUN 11.2 UA 4.9 TC 150 LDL-C 87 Na 140 K 3.9 CRP 0.1 BNP 430 Prescription drug: Aspirin 100 mg, clopidogrel 75 mg, bisoprolol 1.25 mg Pitavastatin 2 mg, Nicorandil 15 mg, Nifedipine CR 20 mg

8 EKG Chest X-p on addmission sinus rhythm, left axis deviation, And ST depression in V4-6 CTR 48%, no congestive change in the lung field

9 Coronary Angiography

10 Coronary Angiography Target lesion LAD#6~#7: diffuse long lesion ( 75%~90%)

11 PCI (Coronary intervention)

12 PCI system and PCI devices Rt. Femoral approach 8Fr. (TFI) GC: Hyperion JL4.0 8Fr. (SJM) GW: Sion (Asahi intec.) Sion Blue Asahi Soft Rotawire Floppy BC: NC Tenkuφ3.5mm x 8 mm Sprinter Legend φ3.0mmx12mm STENT: Resolute Integrity (R-ZES)φ3.0mmx30mm Resolute Integrity (R-ZES)φ3.5mmx38mm Imaging device : IVUS (Bosten) Rotablation : Burr φ1.5mm ppm/min.

13 Rotablation Rota burrφ1.5mm(190000ppm/min.) Post ablation

14 Stent deployment R-ZES φ3.5mm x 30mm R-ZES φ3.5mm x 38mm (With protecting Diagnal Br.)

15 Protect D1 with GW before stenting We tried to cross diagonal branches with a new sion blue!

16 However!!?

17 What happened??

18 Resident said to me Doctor, Guide Wire does not move at all!!"

19 Yeah, stop lying like that!! It is be joking, Why??

20 Doctor!!, "It is true!!"

21 "Well then, would you replace me with PCI operator? Oh, really, really? GW does not move at all!!!! Oh My God!!! Really troubled! Under repaired!! We could not see Merlion yesterday Oh, What should I do now???"

22 But he wired only a few seconds. An accident happened at the first contact with the stent! When he attempted pass new Sion blue (the third GW) through the stent strut from inside the stent, GW had been stucked on the stent (R-ZES)

23 Status was shown as a still CAG image Sion blue D1 Protect GW (Stent underlay) Third GW(new GW) D1 GW(second) : Asahi Soft LAD GW (first GW) : Sion

24 Sion blue and Resolute integrity were trapped! Entrapment!

25 Bail out It was snowing in Nagasaski city last week.

26 Management of removal Although we tried to remove GW by using technique of conversion of respiration and change of posture/removal method with micro catheter and balloon, GW did not move at all.

27 Rotation angiography

28 Elongation of R-ZES As if a complex, GW combined with the stent and GW did not detach at all. We pulled out the entire PCI system. GW could not be removed and the stent had been extended from LAD to LMT (Elongation).

29 Thrombus in LMT Thrombosis was formed in LMT and it had been increased.

30 And then hemodynamics had collapsed... So, IABP insertion (Lt. FA) Stability of hemodynamics Disappearance of chest pain We made it available the second GC from the brachial artery (Right Brachial approach)

31 Removal methods and techniques when GW is trapped Percutaneous Methods Double or triple Wire technique Deep wedging of GC and traction of the system Retrieval using Balloon inflation technique Retrieval by snare loop Retrieval using micro catheter Extraction with Biotome Surgical withdrawal, Extraction ( with CABG ) Conservative observation / therapy (with medication)

32 Management approach used for entrapped GW 50% % 43.8% % % Percutaneous Retrieval Surgical Extraction Conservative therapy (Current Cardiology Review,2013,9,260~266)

33 Removal by Gooseneck snare The deformed stent was caught by a snare catheter and pulled toward the GC direction ( With moderate power ).

34 Recovery technique by snare R-ZES and sion blue could be collected together in the 8Fr. sheath (Bail-out)

35 Coronary angiography immediately after removal of GW and STENT complex There was no damage and injury such as coronary artery rupture, major dissection, occlusion, spasm and Coronary artery Flow was normal. Also, fortunately there were no remains of GW and the stent!

36 Re-PCI Again R-ZES (φ3.0mm x 30mm) had been deployed, again ( Without protection D1)

37 Final angiography Good revascularization had be done

38 Follow up CAG (one year later) There was no restenosis at the treatment site (in LAD).

39 The whole system of the recovered system (appearance) The tip of the system Snare

40 Recovered stent and GW (Magnified picture) The stent and GW were intricately intertwined and the stent platform had been broken completely.

41 Super enlarged photograph The proximal end of the stent The distal end of the stent Ultra magnifying picture of Part B The stretched guide wire spring

42 STENT and the tip of the GW The guide wire distal end portion The stretched guide wire spring SION blue chip Black discoloration caused during the returning period due to exposure to physiological saline or body fluids is observed.

43 Single coil Structure of tip of Sion blue Composite core Ropecoil Ropecoil; Overlapping core wires - Prevention of Kinking - Strong for torque

44 イラストは説明用のイメージです Composite core Ball tip - Joining of core Spring coil - Application of coating material - Torque transmission

45 Continuous Sinusoid Technology Integrity Platform A new manufacturing method for modular stent design applied in the Integrity BMS and Resolute Integrity DES. Sinusoid-Formed Wire Helical Wrap Laser-Fusion A single, continuous piece of wire is taken and formed into the sinusoidal shape. It is then wrapped around a mandrel to give the cylindrical shape of the stent. The stent is then fused in strategic locations to ensure maximum flexibility and conformability, without the risk of unraveling.

46 Integrity Platform Sinusoidal Design Allows for Continuous Flexibility Flex Separate stiff segments connected by flexible connectors limit range of motion Flex Continuous sinusoid technology will flex continually 115 Bend Continuous sinusoid technology allows for continuous flex, which is not possible with laser-cut stents

47 Conjecture Distortion of Spring coil at Composite core part of Sion blue or deformed part (gap) when bending the GW tip shape was intertwined with the stent strut (R-ZES), which might be considered main cause of this incident.

48 Literature consideration The broken or retained GW is a rare complications of PCI, with an estimate incidence of 0.1~0.2 %.. According to Goksin et al. 'S report, guidewires and catheters (Such as balloon / IVUS), about half of cases where removal was difficult. Half cases of guide wire traps have been resolved by surgical procedures.

49 Summary We were able to bail out by using Gooseneck catheter in rare complication.

50 Conclusion (1) Intervention GW entrapment is rare complication of PCI. PCI operators should be aware of this complication and be familiar with measures to appropriately manage it.

51 Conclusion (2) GW tip and stent strut trap ( It looks like a wisdom ring...? ) We experienced unexpected case of complication that was extremely difficult and very very difficult!!

52 Although there is a scenario in PCI treatment, an unexpected incident can occur at all. It's almost like life

53 Thank you very much for your attention and listening!! It is very very cold in Japan now!! It is snowing in Japan It may may snow in Singapore????

54

55 Summary We were able to bail out by using Gooseneck catheter in rare complication. Generally, stent underlayment or between GW stents calcification Sandwiching is the cause of difficulty in removal Generally, for stent underlayment or between stents or for calcification In this case, the case where the GW tip itself was directly stacked on the stent strut I reported that I experienced a very rare complication Sandwiching is the cause of difficulty in removal.

56 Removal methods and techniques when GW is trapped By passing the micro catheter and balloon catheter to the tip of the GW sandwiched between the blood vessel wall and the stent, it would be removed by decreasing the resistance to the guide wire Using Goose-neck snare, biopsy catheter, Two-wire technique for removal Surgical withdrawal (including CABG) Conservative observation (with medication)

57 Conclusion GW tip and stent strut trap ( It looks like a wisdom ring...? ) We experienced unexpected case of complication that was extremely difficult and very very difficult!!

58 Removal methods and techniques when GW is trapped By passing the micro catheter and balloon catheter to the tip of the GW sandwiched between the blood vessel wall and the stent, it would be removed by decreasing the resistance to the guide wire Using Goose-neck snare, biopsy catheter, Two-wire technique for removal Surgical withdrawal, Extraction ( with CABG ) Conservative observation/ therapy (with medication)

59 Background Recently, the development and progress of PCI related devices have been so remarkable. PCI operators should use new devices accurately and safely, and should perform PCI accurately and more efficiently. However, while PCI operators have a low probability, they may encounter incidental symptoms or complications that are quite unexpected. PCI operators must solve the unexpectedly tense troubles and complications encountered by chance with appropriate and prompt judgment and trained skill for PCI.

60

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