- Email: [email protected]
Saphenous vein graft sacrifice following native vessel PCI is safe and associated with favourable longer-term outcomes
CARREV-01498; No of Pages 5 Cardiovascular Revascularization Medicine xxx (xxxx) xxx
Contents lists available at ScienceDirect
Cardiovascular Revascularization Medicine
Saphenous vein graft sacrifice following native vessel PCI is safe and associated with favourable longer-term outcomes☆ Simon J. Wilson a,⁎, Colm G. Hanratty a, Mark S. Spence a, Colum G. Owens a, Johannes Rigger a, James C. Spratt b, Simon J. Walsh a a b
Belfast Health and Social Care Trust, Belfast, United Kingdom St George's University NHS Trust, London, United Kingdom
a r t i c l e
i n f o
Article history: Received 29 October 2018 Received in revised form 4 January 2019 Accepted 18 January 2019 Available online xxxx
a b s t r a c t Background: Competitive flow from saphenous vein grafts (SVG) that remain patent following percutaneous coronary intervention (PCI) of the native vessel may compromise durability of the reconstructed vessel. SVG sacrifice has been advocated, but the safety and longer-term outcomes of this are unknown. Methods: We retrospectively reviewed all post-bypass patients who following successful PCI of the native vessel underwent attempted saphenous vein graft (SVG) closure between January 2014 and July 2018 in two institutions. The co-primary end-points of interest were safety and target lesion failure (TLF), defined as a composite of cardiac death, target vessel recurrent myocardial infarction or clinically driven target lesion revascularisation (TLR). Results: Of the 33 consecutive patients included, the reconstructed native vessel was a chronic total occlusion (CTO) in 93.9% of patients (n = 31) with a mean J-CTO score of 3.2 (±1.1) SVG closure was successful in 97.0% of patients (n = 32). Amplatzer Vascular Plugs (AVP; Abbott Vascular) were used in all patients with most grafts closed by a single plug (72.7%). The average procedure time was 20.1 min with evidence of a short learning curve. Over a mean follow up of 602 (±393) days from the date of SVG closure, the incidence of TLF was 9.1% (n = 3). There was an additional case of targe vessel failure (TVF) due to progression of native vessel disease not treated at the index procedure. SVG closure resulted in only 1 episode of “slow flow” that was transient and self-resolving. There were no other associated peri-procedural or in-hospital complications. Conclusion: Following native vessel PCI, SVG sacrifice may be considered to terminate the potentially deleterious effects of residual competitive flow. In selected cases, this approach achieves high success rate and favourable longer-term outcomes. © 2019 Elsevier Inc. All rights reserved.
1. Introduction The long-term patency of saphenous vein grafts (SVGs) used in coronary artery bypass grafting (CABG) means that for many post-bypass patients further revascularisation is required [1–4]. Percutaneous coronary intervention (PCI) of the native vessel is the preferred treatment strategy for the majority of these patients because of the increased morbidity and mortality associated with surgical reoperation and SVG PCI [5–9]. However, if the graft is not already occluded, it can remain patent with competitive flow evident. This may compromise durability of Abbreviations: AVP, Amplatzer vascular plug; CTO, chronic total occlusion; ITA, internal thoracic artery; J-CTO, Japanese CTO; PCI, percutaneous coronary intervention; SD, standard deviation; SVG, saphenous vein graft; TLF, target lesion failure; TLR, target lesion revascularisation; TVF, target vessel failure. ☆ Conflict(s) of Interest/Declarations/Acknowledgements: Nil.Funding: Nil. ⁎ Corresponding author at: Royal Victoria Hospital, Belfast Health and Social Care Trust, Belfast, United Kingdom. E-mail address: [email protected] (S.J. Wilson).
the reconstructed native vessel with reports of early target lesion failure (TLF) supported by evidence that non-laminar flow and zones of recirculation are associated with vascular dysfunction, stent restenosis and thrombosis [10–16]. To negate this issue SVG sacrifice has been advocated, but the safety and outcomes of this have yet to be reported. The present study describes our experience of SVG closure following PCI to the native vessel, including technical aspects, safety and longer-term outcomes. 2. Methods 2.1. Patient population We retrospectively reviewed all post-bypass patients who between January 2014 and July 2018 in the Royal Victoria Hospital, Belfast and Royal Infirmary of Edinburgh, Edinburgh underwent attempted SVG closure to negate residual competitive flow following PCI of the native vessel.
https://doi.org/10.1016/j.carrev.2019.01.025 1553-8389/© 2019 Elsevier Inc. All rights reserved.
Please cite this article as: S.J. Wilson, C.G. Hanratty, M.S. Spence, et al., Saphenous vein graft sacrifice following native vessel PCI is safe and associated with favourable longer-term outcomes, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.01.025
2
S.J. Wilson et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx
2.2. Clinical outcomes Comprehensive outcome data were obtained from detailed review of case notes and electronic health records (Northern Ireland Electronic Care Record (NIECR) and TrakCare, Intersystems, Cambridge, MA). The co-primary end-points of interest were safety and target lesion failure (TLF), defined as a composite of cardiac death, target vessel related myocardial infarction or clinically driven target lesion revascularisation (TLR). Secondary outcomes of interest included in-hospital events and target vessel failure (TVF). 2.3. Definitions A chronic total occlusion (CTO) was defined as angiographic evidence of a total occlusion with Thrombolysis In Myocardial Infarction (TIMI) grade 0 flow and estimated duration of ≥3 months. Documented CTO characteristics are described according to the J-CTO criteria [17]. A graft was recorded as aneurysmal if any segment was N5.5 mm in diameter. SVG closure success was defined as TIMI grade 0 flow or TIMI ≤1 flow with complete resolution of competitive flow. The procedure time for graft closure was taken from the initial attempt to cannulate or wire the graft until the final check angiogram confirming closure success. 2.4. Statistics Continuous variables are expressed as means ± standard deviation (SD), categorical variables are expressed as total number and percentage unless otherwise stated. 3. Results 3.1. Patient and vessel characteristics All 33 patients (n = 30, Belfast; n = 3, Edinburgh) who underwent attempted SVG sacrifice were included. Mean age was 70.8 y (±8.0) and 90.9% (n = 30) were male. The grafted native vessel was the right coronary artery (RCA), left circumflex artery (LCX), and left anterior descending (LAD) in 66.7%, 27.3%, and 6.1% of patients respectively. In 93.9% (n = 31) of cases, the native vessel was a CTO (Table 1). The indication for native vessel revascularisation was graft failure leading to chronic stable angina in 57.6% of patients (n = 19) and acute coronary syndrome in 39.4% of patients (n = 13). Of the 10 patients who had previously had graft PCI, the mechanism of graft failure was stent restenosis/thrombosis in 70.0% of cases (n = 7). One patient underwent SVG closure with concomitant CTO PCI for massive aneurysmal dilatation of the graft with associated right atrial compression (Table 1). All grafts closed were SVGs with a mean age of 17.0 (±8.9) years since surgery. The reason for graft closure was residual competitive flow in all patients. An additional reason in five of these patients was failure of the previously reconstructed native vessel due to accelerated in-stent restenosis (n = 4) or native vessel disease (n = 1; Table 2 & Fig. 1). 3.2. Closure technique Approximately 40% of graft closures (n = 13) were performed at the index procedure. The remaining cases were undertaken as either a staged procedure (n = 15) or following restenosis of the native vessel (n = 5). Access was radial in 57.6% (n = 19) and femoral in 42.4% (n = 14) of patients. The success rate was 97.0% (n = 32). In the one patient where graft closure could not be achieved, this was due to an inability to deliver the occluder device. Amplatzer vascular plugs (AVP II, III or IV; Abbott Vascular) were used in all patients with an additional neurovascular coil implanted in one patient. The majority of grafts were closed with a single plug (72.7%; Table 2).
Table 1 Patient and PCI characteristics. Variable Age, y (SD) Male sex (%) BMI (SD) Diabetes (%) Hypertension (%) Previous CVA (%) Peripheral vascular disease (%) Previous myocardial infarction (%) Previous PCI (%) Current smoker (%) Chronic renal failure^ (%) LVEF ≤50% (%) Indication for PCI (%) ACS Chronic stable angina Other Target vessel (%) LAD LCx RCA Target vessel a CTO (%) Proximal cap blunt or ambiguous (%) Distal cap blunt or ambiguous (%) Calcification (%) Tortuosity (%) Occlusion length (SD) Previous attempt at CTO PCI (%) J-CTO score (SD) Recanalization technique (%) AWE ADR RWE RDR Graft used as a retrograde conduit (%)
Mean/Incidence 70.8 (8.0) 30 (90.9) 29.1 (4.3) 9 (27.3) 25 (75.8) 4 (12.1) 6 (18.2) 27 (81.8) 27 (81.8) 4 (12.1) 9 (27.2) 13 (39.4) 13 (39.4) 19 (57.6) 1 (3.0) 2 (6.1) 9 (27.3) 22 (66.7) 31 (93.9) 19 (61.3) 14 (45.2) 29 (93.5) 21 (67.7) 34.0 (20.1) 4 (12.9) 3.2 (1.1) 7 (21.2) 1 (3.0) 2 (6.1) 23 (69.7) 23 (69.7)
^eGFR b60 mL/min. Abbreviations used: BMI, body mass index; CVA, cerebrovascular accident; LVEF, left ventricle ejection fraction; CTO, chronic total occlusion; PCI, percutaneous coronary intervention; LAD, left anterior descending; LCx, left circumflex; RCA. right coronary artery; J-CTO; Japanese-CTO; AWE, antegrade wire escalation; ADR, antegrade dissection re-entry; RWE, retrograde wire escalation; and RDR, retrograde dissection re-entry.
The closure device was delivered through the guide (AVP II or III) or a mother-in-daughter catheter (AVP IV). If the device was to be delivered distally, a Multipurpose A 1 guide (MPA 1; Cordis) or Heartrail catheter (Terumo) were advanced to the landing zone (Fig. 2). The average procedure time was 20.1 (±13.9) mins (Table 2). 3.3. Safety One episode of “slow flow” occurred at the time of SVG closure that was transient and resolved without intervention. No other periprocedural or in-hospital complications occurred including SVG perforation, access site complication, myocardial infarction, stroke and death. 3.4. Outcomes The incidence of TLF was 9.1% (n = 3) over a mean follow up of 602 (±393) days from the date of graft closure. One patient suffered an acute coronary syndrome secondary to stent fracture. The other two patients developed recurrent angina and were found to have obstructive in-stent restenosis at angiography. An additional case of target vessel failure (TVF) was recorded. This was due to progression of native vessel disease not treated at the index procedure. In all cases, the sacrificed graft was checked and confirmed to be occluded (Table 3). 4. Discussion This is the first report of the longer-term safety and outcomes of deliberate SVG sacrifice to mitigate the potentially deleterious effects
Please cite this article as: S.J. Wilson, C.G. Hanratty, M.S. Spence, et al., Saphenous vein graft sacrifice following native vessel PCI is safe and associated with favourable longer-term outcomes, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.01.025
S.J. Wilson et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx Table 2 Graft and closure characteristics. Variable
Mean/Incidence
Age of graft, y (SD) Severity of graft disease (%) Acute occlusion 90–99% 70–89% Aneurysmal Anastomosis stented across at index procedure (%) Reason(s) for graft closure (%) Competitive flow Accelerated restenosis of the native vessel / stent Graft closed at index procedure (%) Graft closure success (%) Access (%) Radial Femoral Attempted closure mechanism (%) Plug Coil No. of plugs implanted (%) Zero One Two Largest plug diameter, mm (SD)^ Total pre-deployment plug length, mm (SD)^ Procedure time, min (SD)
17.0 (8.9) 2 (6.1) 19 (57.6) 9 (27.2) 6 (18.2) 10 (30.3) 33 (100) 5 (15.2) 13 (39.4) 29 (96.7) 19 (57.6) 14 (42.4) 33 (100) 1 (3.0) 1 (3.0) 24 (72.7) 8 (24.2) 8.1 (2.8) 9.4 (5.1) 20.1 (13.9)
^
Data only available on 29 of 32 cases. Abbreviations used: ISR, in-stent restenosis.
3
of residual competitive flow following PCI of the native vessel. Our main findings are that in selected patients SVG closure is safe, easy to perform and associated with a high success rate. SVG lesions are characterised by a high plaque burden, friable material and super-imposed thrombus such that graft PCI is associated with a high incidence of distal embolisation and procedural myocardial infarction [8]. Avoiding this risk is one of the main benefits of native vessel over graft intervention that could potentially be compromised by graft instrumentation during closure. However, we found that SVG closure was associated with a markedly low complication rate with only episode of transient “slow flow” and no other peri-procedural or in-hospital events. This can be explained by important distinctions between the two techniques. Balloon angioplasty and/or stent implantation necessitates high pressure inflations to aggressively modify plaque within the most diseased vein graft segments. In contrast, SVG closure uses either coils or low pressure, self-expanding devices that are generally deployed proximal and therefore remote to the most adversely affected areas. There was a high degree of native vessel anatomical complexity (true CTO in 93.9% of patients, mean J-CTO score 3.2 ± 1.1). Despite this, rates of TLF and TVF following SVG closure were low at 9.1% and 12.1% respectively over a mean follow-up of almost 2 years. In the absence of a comparator group we view this data as hypothesis generating, with appropriately designed clinical trials required to establish whether SVG closure is beneficial or not. However, it is noteworthy that in the only CTO registry to include 2 year outcomes in post-bypass
A
B
C
D
E
F
Fig. 1. Early restenosis in the presence of residual competitive flow from a patent diseased SVG. [A] There is a long CTO of the native RCA. [B,C] Following successful recanalisation, the SVG remains patent (arrows) with competitive flow evident (arrowhead). [D] Within 5 months the patient represents with angina due to accelerated in-stent restenosis (arrowheads). Competitive flow is seen in the proximal PDA (arrow). [E] After treatment of the restenotic segments, the SVG was closed with an Amplatzer vascular plug II (arrows). [F] Final angiogram demonstrating resolution of competitive flow.
Please cite this article as: S.J. Wilson, C.G. Hanratty, M.S. Spence, et al., Saphenous vein graft sacrifice following native vessel PCI is safe and associated with favourable longer-term outcomes, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.01.025
4
S.J. Wilson et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx
A
B
C
MPA 1 guide CTO
leng
th
PLA
SVG Balloon PDA Competitive flow
E
D
AVP II
F
Second occluder device Residual antegrade flow Competitive flow resolved
Fig. 2. SVG closure following native vessel CTO PCI. [A] A long RCA CTO is present with a diseased SVG to the PDA. [B] Following successful native vessel recanalisation, residual competitive flow is evident. [C] A 7 F MPA 1 guide is advanced into the SVG with balloon tracking. [D] The first plug fails to adequately close the SVG. [E] A second plug is successful with [F] a final angiogram confirming resolution of competitive flow and a good CTO PCI outcome. Abbreviations used: SVG; saphenous vein graft; PLA, posterolateral artery; PDA, posterior descending artery; MPA 1, Multipurpose A 1; and AVP, Amplatzer vascular plug.
patients, the incidence of TVF was higher than in our study at 16.1% despite a lower mean J-CTO score of 2.3 ± 1.2 [18]. Amplatzer Vascular Plugs were used in all patients. These endovascular embolisation devices consist of a delivery cable and self-expanding nitinol plug that is recapturable and redeployable. In our experience they offer advantages over coils in terms of efficiency, efficacy and precision. The AVP II is a tri-lobar plug suited to most SVGs, while the AVP IV is a lower profile bi-lobar device with a more flexible delivery system that is useful in smaller calibre and tortuous anatomy. The larger AVP II is delivered through a guide (minimum internal diameter 5–9 F), whereas the AVP IV can be delivered through a 5 F mother-in-daughter system. If an AVP II is to be delivered distally, we recommend a multi-purpose guide as this catheter shape is most suited to tracking down the SVG. Table 3 Safety and outcomes. Event Peri-procedural complication Transient slow flow Other In-hospital complication Target lesion failure Target lesion revascularisation Target vessel recurrent myocardial infarction Cardiac death Target vessel failure
Incidence (%) 1 (3.0) 1 (3.0) 0 (0) 0 (0) 3 (9.1) 3 (9.1) 1 (3.0) 0 (0) 4 (12.1)
Our initial practice was to close each graft with 2 plugs, with the first sited in close proximity to the most stenosed SVG segment and the second sited close to the proximal anastomosis. However, it proved very challenging to deliver a device distally in grafts to the LCX owing to their characteristic sigmoid shape, and it quickly became apparent that a single plug was sufficient in the majority of cases. Two plugs were therefore generally reserved for markedly aneurysmal grafts or if a single plug failed to close the graft satisfactorily. Our preference was to site at least one plug close to the SVG-aorta interface. This was to minimise the length of occluded graft exposed to aortic pressures so as to reduce any risk of subsequent aneurysmal dilatation. It should be noted that before releasing the closure device, a check angiogram is recommended. This allows repositioning and insertion of a second occluder device if the initial plug is felt unlikely to be adequate. In terms of sizing, selecting a device that is approximately 30–50% above the reference diameter proved most effective in terms of deliverability and efficacy. We also observed a short learning curve. The average procedure time was 28 min for the first 10 cases, compared to 14 min for the remaining 23 cases. This study has several limitations. First, it was retrospective and thus while we included all patients who had an attempt at SVG closure, the high success rate may be subject to case selection. Second, there were no pre-defined criteria for SVG closure except for the presence of competitive flow. We attempted to classify the severity of competition based on TIMI flow down the SVG and in the native vessel, but this was too dependent on the degree of catheter engagement and forcefulness of contrast injection to be of use. Third, whether some of the SVGs
Please cite this article as: S.J. Wilson, C.G. Hanratty, M.S. Spence, et al., Saphenous vein graft sacrifice following native vessel PCI is safe and associated with favourable longer-term outcomes, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.01.025
S.J. Wilson et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx
would have closed naturally over time is unknown. Interestingly, there was no apparent relationship between the severity of graft obstruction and the likelihood of competitive flow immediately post native vessel PCI with the majority of SVGs having a least one segment N90% stenotic. Finally, there was no comparator group. However, as this technique is already undertaken but largely unreported, our primary objective was to describe the safety and longer-term outcomes. 5. Conclusion We report following native vessel PCI, SVG sacrifice may be considered to terminate the potentially deleterious effects of residual competitive flow. In selected cases, this approach achieves high success rate and favourable longer-term outcomes. Our results call for further studies to establish the benefit of this approach. References [1] Fitzgibbon GM, Kafka HP, Leach AJ, Keon WJ, Hooper GD, Burton JR. Coronary bypass graft fate and patient outcome: angiographic follow-up of 5,065 grafts related to survival and reoperation in 1,388 patients during 25 years. J Am Coll Cardiol 1996;28:616–26. [2] Alexander JH, Hafley G, Harrington RA, Peterson ED, Ferguson TB, Lorenz TJ, et al. Efficacy and safety of edifoligide, an E2F transcription factor decoy, for prevention of vein graft failure following coronary artery bypass graft surgery: PREVENT IV: a randomized controlled trial. JAMA 2005;294:2446–54. [3] Tatoulis J, Buxton BF, Fuller JA. Patencies of 2127 arterial to coronary conduits over 15 years. Ann Thorac Surg 2004;77:93–101. [4] Widimsky P, Straka Z, Stros P, Jirasek K, Dvorak J, Votava J, et al. One-year coronary bypass graft patency: a randomized comparison between off-pump and on-pump surgery angiographic results of the PRAGUE-4 trial. Circulation 2004;110:3418–23. [5] Morrison DA, Sethi G, Sacks J, Henderson WG, Grover F, Sedlis S, et al. Percutaneous coronary intervention versus repeat bypass surgery for patients with medically refractory myocardial ischemia: AWESOME randomized trial and registry experience with post-CABG patients. J Am Coll Cardiol 2002;40:1951–4.
5
[6] Bundhoo SS, Kalla M, Anantharaman R, Morris K, Chase A, Smith D, et al. Outcomes following PCI in patients with previous CABG: a multi centre experience. Catheter Cardiovasc Interv 2011;78:169–76. [7] Blachutzik F, Achenbach S, Troebs M, Roether J, Nef H, Hamm C, et al. Angiographic findings and revascularization success in patients with acute myocardial infarction and previous coronary bypass grafting. Am J Cardiol 2016;118:473–6. [8] Paul TK, Bhatheja S, Panchal HB, Zheng S, Banerjee S, Rao SV, et al. Outcomes of saphenous vein graft intervention with and without embolic protection device. Circ Cardiovasc Interv 2017;10. [9] Brilakis ES, O'Donnell CI, Penny W, Armstrong EJ, Tsai T, Maddox TM, et al. Percutaneous coronary intervention in native coronary arteries versus bypass grafts in patients with prior coronary artery bypass graft surgery: insights from the veterans affairs clinical assessment, reporting, and tracking program. JACC Cardiovasc Interv 2016;9:884–93. [10] Uematsu M, Ohara Y, Navas JP, Nishida K, Murphy TJ, Alexander RW, et al. Regulation of endothelial cell nitric oxide synthase mRNA expression by shear stress. Am J Phys Cell Phys 1995;269:C1371–8. [11] Diamond S, Eskin S, McIntire L. Fluid flow stimulates tissue plasminogen activator secretion by cultured human endothelial cells. Science 1989;243:1483–5. [12] Gimbrone Jr M. Endothelial dysfunction, hemodynamic forces, and atherosclerosis. Thromb Haemost 2017;82:722–6. [13] Asakura T, Karino T. Flow patterns and spatial distribution of atherosclerotic lesions in human coronary arteries. Circ Res 1990;66:1045–66. [14] Kinlay S. Coronary flow velocity and disturbed flow predict adverse clinical outcome after coronary angioplasty. Arterioscler Thromb Vasc Biol 2002;22:1334–40. [15] Chiu J-J, Chien S. Effects of disturbed flow on vascular endothelium: pathophysiological basis and clinical perspectives. Physiol Rev 2011;91:327–87. [16] Dautov R, Manh Nguyen C, Altisent O, Gibrat C, Rinfret S. Recanalization of chronic total occlusions in patients with previous coronary bypass surgery and consideration of retrograde access via saphenous vein grafts. Circ Cardiovasc Interv 2016;9: e003515. [17] Morino Y, Abe M, Morimoto T, Kimura T, Hayashi Y, Muramatsu T, et al. Predicting successful guidewire crossing through chronic total occlusion of native coronary lesions within 30 minutes: the J-CTO (Multicenter CTO Registry in Japan) score as a difficulty grading and time assessment tool. JACC Cardiovasc Interv 2011; 4:213–21. [18] Azzalini L, Ojeda S, Karatasakis A, Maeremans J, Tanabe M, La Manna A, et al. Long-term outcomes of percutaneous coronary intervention for chronic total occlusion in patients who have undergone coronary artery bypass grafting vs those who have not. Can J Cardiol 2018;34:310–8.
Please cite this article as: S.J. Wilson, C.G. Hanratty, M.S. Spence, et al., Saphenous vein graft sacrifice following native vessel PCI is safe and associated with favourable longer-term outcomes, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.01.025
Contents lists available at ScienceDirect
Cardiovascular Revascularization Medicine
Saphenous vein graft sacrifice following native vessel PCI is safe and associated with favourable longer-term outcomes☆ Simon J. Wilson a,⁎, Colm G. Hanratty a, Mark S. Spence a, Colum G. Owens a, Johannes Rigger a, James C. Spratt b, Simon J. Walsh a a b
Belfast Health and Social Care Trust, Belfast, United Kingdom St George's University NHS Trust, London, United Kingdom
a r t i c l e
i n f o
Article history: Received 29 October 2018 Received in revised form 4 January 2019 Accepted 18 January 2019 Available online xxxx
a b s t r a c t Background: Competitive flow from saphenous vein grafts (SVG) that remain patent following percutaneous coronary intervention (PCI) of the native vessel may compromise durability of the reconstructed vessel. SVG sacrifice has been advocated, but the safety and longer-term outcomes of this are unknown. Methods: We retrospectively reviewed all post-bypass patients who following successful PCI of the native vessel underwent attempted saphenous vein graft (SVG) closure between January 2014 and July 2018 in two institutions. The co-primary end-points of interest were safety and target lesion failure (TLF), defined as a composite of cardiac death, target vessel recurrent myocardial infarction or clinically driven target lesion revascularisation (TLR). Results: Of the 33 consecutive patients included, the reconstructed native vessel was a chronic total occlusion (CTO) in 93.9% of patients (n = 31) with a mean J-CTO score of 3.2 (±1.1) SVG closure was successful in 97.0% of patients (n = 32). Amplatzer Vascular Plugs (AVP; Abbott Vascular) were used in all patients with most grafts closed by a single plug (72.7%). The average procedure time was 20.1 min with evidence of a short learning curve. Over a mean follow up of 602 (±393) days from the date of SVG closure, the incidence of TLF was 9.1% (n = 3). There was an additional case of targe vessel failure (TVF) due to progression of native vessel disease not treated at the index procedure. SVG closure resulted in only 1 episode of “slow flow” that was transient and self-resolving. There were no other associated peri-procedural or in-hospital complications. Conclusion: Following native vessel PCI, SVG sacrifice may be considered to terminate the potentially deleterious effects of residual competitive flow. In selected cases, this approach achieves high success rate and favourable longer-term outcomes. © 2019 Elsevier Inc. All rights reserved.
1. Introduction The long-term patency of saphenous vein grafts (SVGs) used in coronary artery bypass grafting (CABG) means that for many post-bypass patients further revascularisation is required [1–4]. Percutaneous coronary intervention (PCI) of the native vessel is the preferred treatment strategy for the majority of these patients because of the increased morbidity and mortality associated with surgical reoperation and SVG PCI [5–9]. However, if the graft is not already occluded, it can remain patent with competitive flow evident. This may compromise durability of Abbreviations: AVP, Amplatzer vascular plug; CTO, chronic total occlusion; ITA, internal thoracic artery; J-CTO, Japanese CTO; PCI, percutaneous coronary intervention; SD, standard deviation; SVG, saphenous vein graft; TLF, target lesion failure; TLR, target lesion revascularisation; TVF, target vessel failure. ☆ Conflict(s) of Interest/Declarations/Acknowledgements: Nil.Funding: Nil. ⁎ Corresponding author at: Royal Victoria Hospital, Belfast Health and Social Care Trust, Belfast, United Kingdom. E-mail address: [email protected] (S.J. Wilson).
the reconstructed native vessel with reports of early target lesion failure (TLF) supported by evidence that non-laminar flow and zones of recirculation are associated with vascular dysfunction, stent restenosis and thrombosis [10–16]. To negate this issue SVG sacrifice has been advocated, but the safety and outcomes of this have yet to be reported. The present study describes our experience of SVG closure following PCI to the native vessel, including technical aspects, safety and longer-term outcomes. 2. Methods 2.1. Patient population We retrospectively reviewed all post-bypass patients who between January 2014 and July 2018 in the Royal Victoria Hospital, Belfast and Royal Infirmary of Edinburgh, Edinburgh underwent attempted SVG closure to negate residual competitive flow following PCI of the native vessel.
https://doi.org/10.1016/j.carrev.2019.01.025 1553-8389/© 2019 Elsevier Inc. All rights reserved.
Please cite this article as: S.J. Wilson, C.G. Hanratty, M.S. Spence, et al., Saphenous vein graft sacrifice following native vessel PCI is safe and associated with favourable longer-term outcomes, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.01.025
2
S.J. Wilson et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx
2.2. Clinical outcomes Comprehensive outcome data were obtained from detailed review of case notes and electronic health records (Northern Ireland Electronic Care Record (NIECR) and TrakCare, Intersystems, Cambridge, MA). The co-primary end-points of interest were safety and target lesion failure (TLF), defined as a composite of cardiac death, target vessel related myocardial infarction or clinically driven target lesion revascularisation (TLR). Secondary outcomes of interest included in-hospital events and target vessel failure (TVF). 2.3. Definitions A chronic total occlusion (CTO) was defined as angiographic evidence of a total occlusion with Thrombolysis In Myocardial Infarction (TIMI) grade 0 flow and estimated duration of ≥3 months. Documented CTO characteristics are described according to the J-CTO criteria [17]. A graft was recorded as aneurysmal if any segment was N5.5 mm in diameter. SVG closure success was defined as TIMI grade 0 flow or TIMI ≤1 flow with complete resolution of competitive flow. The procedure time for graft closure was taken from the initial attempt to cannulate or wire the graft until the final check angiogram confirming closure success. 2.4. Statistics Continuous variables are expressed as means ± standard deviation (SD), categorical variables are expressed as total number and percentage unless otherwise stated. 3. Results 3.1. Patient and vessel characteristics All 33 patients (n = 30, Belfast; n = 3, Edinburgh) who underwent attempted SVG sacrifice were included. Mean age was 70.8 y (±8.0) and 90.9% (n = 30) were male. The grafted native vessel was the right coronary artery (RCA), left circumflex artery (LCX), and left anterior descending (LAD) in 66.7%, 27.3%, and 6.1% of patients respectively. In 93.9% (n = 31) of cases, the native vessel was a CTO (Table 1). The indication for native vessel revascularisation was graft failure leading to chronic stable angina in 57.6% of patients (n = 19) and acute coronary syndrome in 39.4% of patients (n = 13). Of the 10 patients who had previously had graft PCI, the mechanism of graft failure was stent restenosis/thrombosis in 70.0% of cases (n = 7). One patient underwent SVG closure with concomitant CTO PCI for massive aneurysmal dilatation of the graft with associated right atrial compression (Table 1). All grafts closed were SVGs with a mean age of 17.0 (±8.9) years since surgery. The reason for graft closure was residual competitive flow in all patients. An additional reason in five of these patients was failure of the previously reconstructed native vessel due to accelerated in-stent restenosis (n = 4) or native vessel disease (n = 1; Table 2 & Fig. 1). 3.2. Closure technique Approximately 40% of graft closures (n = 13) were performed at the index procedure. The remaining cases were undertaken as either a staged procedure (n = 15) or following restenosis of the native vessel (n = 5). Access was radial in 57.6% (n = 19) and femoral in 42.4% (n = 14) of patients. The success rate was 97.0% (n = 32). In the one patient where graft closure could not be achieved, this was due to an inability to deliver the occluder device. Amplatzer vascular plugs (AVP II, III or IV; Abbott Vascular) were used in all patients with an additional neurovascular coil implanted in one patient. The majority of grafts were closed with a single plug (72.7%; Table 2).
Table 1 Patient and PCI characteristics. Variable Age, y (SD) Male sex (%) BMI (SD) Diabetes (%) Hypertension (%) Previous CVA (%) Peripheral vascular disease (%) Previous myocardial infarction (%) Previous PCI (%) Current smoker (%) Chronic renal failure^ (%) LVEF ≤50% (%) Indication for PCI (%) ACS Chronic stable angina Other Target vessel (%) LAD LCx RCA Target vessel a CTO (%) Proximal cap blunt or ambiguous (%) Distal cap blunt or ambiguous (%) Calcification (%) Tortuosity (%) Occlusion length (SD) Previous attempt at CTO PCI (%) J-CTO score (SD) Recanalization technique (%) AWE ADR RWE RDR Graft used as a retrograde conduit (%)
Mean/Incidence 70.8 (8.0) 30 (90.9) 29.1 (4.3) 9 (27.3) 25 (75.8) 4 (12.1) 6 (18.2) 27 (81.8) 27 (81.8) 4 (12.1) 9 (27.2) 13 (39.4) 13 (39.4) 19 (57.6) 1 (3.0) 2 (6.1) 9 (27.3) 22 (66.7) 31 (93.9) 19 (61.3) 14 (45.2) 29 (93.5) 21 (67.7) 34.0 (20.1) 4 (12.9) 3.2 (1.1) 7 (21.2) 1 (3.0) 2 (6.1) 23 (69.7) 23 (69.7)
^eGFR b60 mL/min. Abbreviations used: BMI, body mass index; CVA, cerebrovascular accident; LVEF, left ventricle ejection fraction; CTO, chronic total occlusion; PCI, percutaneous coronary intervention; LAD, left anterior descending; LCx, left circumflex; RCA. right coronary artery; J-CTO; Japanese-CTO; AWE, antegrade wire escalation; ADR, antegrade dissection re-entry; RWE, retrograde wire escalation; and RDR, retrograde dissection re-entry.
The closure device was delivered through the guide (AVP II or III) or a mother-in-daughter catheter (AVP IV). If the device was to be delivered distally, a Multipurpose A 1 guide (MPA 1; Cordis) or Heartrail catheter (Terumo) were advanced to the landing zone (Fig. 2). The average procedure time was 20.1 (±13.9) mins (Table 2). 3.3. Safety One episode of “slow flow” occurred at the time of SVG closure that was transient and resolved without intervention. No other periprocedural or in-hospital complications occurred including SVG perforation, access site complication, myocardial infarction, stroke and death. 3.4. Outcomes The incidence of TLF was 9.1% (n = 3) over a mean follow up of 602 (±393) days from the date of graft closure. One patient suffered an acute coronary syndrome secondary to stent fracture. The other two patients developed recurrent angina and were found to have obstructive in-stent restenosis at angiography. An additional case of target vessel failure (TVF) was recorded. This was due to progression of native vessel disease not treated at the index procedure. In all cases, the sacrificed graft was checked and confirmed to be occluded (Table 3). 4. Discussion This is the first report of the longer-term safety and outcomes of deliberate SVG sacrifice to mitigate the potentially deleterious effects
Please cite this article as: S.J. Wilson, C.G. Hanratty, M.S. Spence, et al., Saphenous vein graft sacrifice following native vessel PCI is safe and associated with favourable longer-term outcomes, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.01.025
S.J. Wilson et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx Table 2 Graft and closure characteristics. Variable
Mean/Incidence
Age of graft, y (SD) Severity of graft disease (%) Acute occlusion 90–99% 70–89% Aneurysmal Anastomosis stented across at index procedure (%) Reason(s) for graft closure (%) Competitive flow Accelerated restenosis of the native vessel / stent Graft closed at index procedure (%) Graft closure success (%) Access (%) Radial Femoral Attempted closure mechanism (%) Plug Coil No. of plugs implanted (%) Zero One Two Largest plug diameter, mm (SD)^ Total pre-deployment plug length, mm (SD)^ Procedure time, min (SD)
17.0 (8.9) 2 (6.1) 19 (57.6) 9 (27.2) 6 (18.2) 10 (30.3) 33 (100) 5 (15.2) 13 (39.4) 29 (96.7) 19 (57.6) 14 (42.4) 33 (100) 1 (3.0) 1 (3.0) 24 (72.7) 8 (24.2) 8.1 (2.8) 9.4 (5.1) 20.1 (13.9)
^
Data only available on 29 of 32 cases. Abbreviations used: ISR, in-stent restenosis.
3
of residual competitive flow following PCI of the native vessel. Our main findings are that in selected patients SVG closure is safe, easy to perform and associated with a high success rate. SVG lesions are characterised by a high plaque burden, friable material and super-imposed thrombus such that graft PCI is associated with a high incidence of distal embolisation and procedural myocardial infarction [8]. Avoiding this risk is one of the main benefits of native vessel over graft intervention that could potentially be compromised by graft instrumentation during closure. However, we found that SVG closure was associated with a markedly low complication rate with only episode of transient “slow flow” and no other peri-procedural or in-hospital events. This can be explained by important distinctions between the two techniques. Balloon angioplasty and/or stent implantation necessitates high pressure inflations to aggressively modify plaque within the most diseased vein graft segments. In contrast, SVG closure uses either coils or low pressure, self-expanding devices that are generally deployed proximal and therefore remote to the most adversely affected areas. There was a high degree of native vessel anatomical complexity (true CTO in 93.9% of patients, mean J-CTO score 3.2 ± 1.1). Despite this, rates of TLF and TVF following SVG closure were low at 9.1% and 12.1% respectively over a mean follow-up of almost 2 years. In the absence of a comparator group we view this data as hypothesis generating, with appropriately designed clinical trials required to establish whether SVG closure is beneficial or not. However, it is noteworthy that in the only CTO registry to include 2 year outcomes in post-bypass
A
B
C
D
E
F
Fig. 1. Early restenosis in the presence of residual competitive flow from a patent diseased SVG. [A] There is a long CTO of the native RCA. [B,C] Following successful recanalisation, the SVG remains patent (arrows) with competitive flow evident (arrowhead). [D] Within 5 months the patient represents with angina due to accelerated in-stent restenosis (arrowheads). Competitive flow is seen in the proximal PDA (arrow). [E] After treatment of the restenotic segments, the SVG was closed with an Amplatzer vascular plug II (arrows). [F] Final angiogram demonstrating resolution of competitive flow.
Please cite this article as: S.J. Wilson, C.G. Hanratty, M.S. Spence, et al., Saphenous vein graft sacrifice following native vessel PCI is safe and associated with favourable longer-term outcomes, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.01.025
4
S.J. Wilson et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx
A
B
C
MPA 1 guide CTO
leng
th
PLA
SVG Balloon PDA Competitive flow
E
D
AVP II
F
Second occluder device Residual antegrade flow Competitive flow resolved
Fig. 2. SVG closure following native vessel CTO PCI. [A] A long RCA CTO is present with a diseased SVG to the PDA. [B] Following successful native vessel recanalisation, residual competitive flow is evident. [C] A 7 F MPA 1 guide is advanced into the SVG with balloon tracking. [D] The first plug fails to adequately close the SVG. [E] A second plug is successful with [F] a final angiogram confirming resolution of competitive flow and a good CTO PCI outcome. Abbreviations used: SVG; saphenous vein graft; PLA, posterolateral artery; PDA, posterior descending artery; MPA 1, Multipurpose A 1; and AVP, Amplatzer vascular plug.
patients, the incidence of TVF was higher than in our study at 16.1% despite a lower mean J-CTO score of 2.3 ± 1.2 [18]. Amplatzer Vascular Plugs were used in all patients. These endovascular embolisation devices consist of a delivery cable and self-expanding nitinol plug that is recapturable and redeployable. In our experience they offer advantages over coils in terms of efficiency, efficacy and precision. The AVP II is a tri-lobar plug suited to most SVGs, while the AVP IV is a lower profile bi-lobar device with a more flexible delivery system that is useful in smaller calibre and tortuous anatomy. The larger AVP II is delivered through a guide (minimum internal diameter 5–9 F), whereas the AVP IV can be delivered through a 5 F mother-in-daughter system. If an AVP II is to be delivered distally, we recommend a multi-purpose guide as this catheter shape is most suited to tracking down the SVG. Table 3 Safety and outcomes. Event Peri-procedural complication Transient slow flow Other In-hospital complication Target lesion failure Target lesion revascularisation Target vessel recurrent myocardial infarction Cardiac death Target vessel failure
Incidence (%) 1 (3.0) 1 (3.0) 0 (0) 0 (0) 3 (9.1) 3 (9.1) 1 (3.0) 0 (0) 4 (12.1)
Our initial practice was to close each graft with 2 plugs, with the first sited in close proximity to the most stenosed SVG segment and the second sited close to the proximal anastomosis. However, it proved very challenging to deliver a device distally in grafts to the LCX owing to their characteristic sigmoid shape, and it quickly became apparent that a single plug was sufficient in the majority of cases. Two plugs were therefore generally reserved for markedly aneurysmal grafts or if a single plug failed to close the graft satisfactorily. Our preference was to site at least one plug close to the SVG-aorta interface. This was to minimise the length of occluded graft exposed to aortic pressures so as to reduce any risk of subsequent aneurysmal dilatation. It should be noted that before releasing the closure device, a check angiogram is recommended. This allows repositioning and insertion of a second occluder device if the initial plug is felt unlikely to be adequate. In terms of sizing, selecting a device that is approximately 30–50% above the reference diameter proved most effective in terms of deliverability and efficacy. We also observed a short learning curve. The average procedure time was 28 min for the first 10 cases, compared to 14 min for the remaining 23 cases. This study has several limitations. First, it was retrospective and thus while we included all patients who had an attempt at SVG closure, the high success rate may be subject to case selection. Second, there were no pre-defined criteria for SVG closure except for the presence of competitive flow. We attempted to classify the severity of competition based on TIMI flow down the SVG and in the native vessel, but this was too dependent on the degree of catheter engagement and forcefulness of contrast injection to be of use. Third, whether some of the SVGs
Please cite this article as: S.J. Wilson, C.G. Hanratty, M.S. Spence, et al., Saphenous vein graft sacrifice following native vessel PCI is safe and associated with favourable longer-term outcomes, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.01.025
S.J. Wilson et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx
would have closed naturally over time is unknown. Interestingly, there was no apparent relationship between the severity of graft obstruction and the likelihood of competitive flow immediately post native vessel PCI with the majority of SVGs having a least one segment N90% stenotic. Finally, there was no comparator group. However, as this technique is already undertaken but largely unreported, our primary objective was to describe the safety and longer-term outcomes. 5. Conclusion We report following native vessel PCI, SVG sacrifice may be considered to terminate the potentially deleterious effects of residual competitive flow. In selected cases, this approach achieves high success rate and favourable longer-term outcomes. Our results call for further studies to establish the benefit of this approach. References [1] Fitzgibbon GM, Kafka HP, Leach AJ, Keon WJ, Hooper GD, Burton JR. Coronary bypass graft fate and patient outcome: angiographic follow-up of 5,065 grafts related to survival and reoperation in 1,388 patients during 25 years. J Am Coll Cardiol 1996;28:616–26. [2] Alexander JH, Hafley G, Harrington RA, Peterson ED, Ferguson TB, Lorenz TJ, et al. Efficacy and safety of edifoligide, an E2F transcription factor decoy, for prevention of vein graft failure following coronary artery bypass graft surgery: PREVENT IV: a randomized controlled trial. JAMA 2005;294:2446–54. [3] Tatoulis J, Buxton BF, Fuller JA. Patencies of 2127 arterial to coronary conduits over 15 years. Ann Thorac Surg 2004;77:93–101. [4] Widimsky P, Straka Z, Stros P, Jirasek K, Dvorak J, Votava J, et al. One-year coronary bypass graft patency: a randomized comparison between off-pump and on-pump surgery angiographic results of the PRAGUE-4 trial. Circulation 2004;110:3418–23. [5] Morrison DA, Sethi G, Sacks J, Henderson WG, Grover F, Sedlis S, et al. Percutaneous coronary intervention versus repeat bypass surgery for patients with medically refractory myocardial ischemia: AWESOME randomized trial and registry experience with post-CABG patients. J Am Coll Cardiol 2002;40:1951–4.
5
[6] Bundhoo SS, Kalla M, Anantharaman R, Morris K, Chase A, Smith D, et al. Outcomes following PCI in patients with previous CABG: a multi centre experience. Catheter Cardiovasc Interv 2011;78:169–76. [7] Blachutzik F, Achenbach S, Troebs M, Roether J, Nef H, Hamm C, et al. Angiographic findings and revascularization success in patients with acute myocardial infarction and previous coronary bypass grafting. Am J Cardiol 2016;118:473–6. [8] Paul TK, Bhatheja S, Panchal HB, Zheng S, Banerjee S, Rao SV, et al. Outcomes of saphenous vein graft intervention with and without embolic protection device. Circ Cardiovasc Interv 2017;10. [9] Brilakis ES, O'Donnell CI, Penny W, Armstrong EJ, Tsai T, Maddox TM, et al. Percutaneous coronary intervention in native coronary arteries versus bypass grafts in patients with prior coronary artery bypass graft surgery: insights from the veterans affairs clinical assessment, reporting, and tracking program. JACC Cardiovasc Interv 2016;9:884–93. [10] Uematsu M, Ohara Y, Navas JP, Nishida K, Murphy TJ, Alexander RW, et al. Regulation of endothelial cell nitric oxide synthase mRNA expression by shear stress. Am J Phys Cell Phys 1995;269:C1371–8. [11] Diamond S, Eskin S, McIntire L. Fluid flow stimulates tissue plasminogen activator secretion by cultured human endothelial cells. Science 1989;243:1483–5. [12] Gimbrone Jr M. Endothelial dysfunction, hemodynamic forces, and atherosclerosis. Thromb Haemost 2017;82:722–6. [13] Asakura T, Karino T. Flow patterns and spatial distribution of atherosclerotic lesions in human coronary arteries. Circ Res 1990;66:1045–66. [14] Kinlay S. Coronary flow velocity and disturbed flow predict adverse clinical outcome after coronary angioplasty. Arterioscler Thromb Vasc Biol 2002;22:1334–40. [15] Chiu J-J, Chien S. Effects of disturbed flow on vascular endothelium: pathophysiological basis and clinical perspectives. Physiol Rev 2011;91:327–87. [16] Dautov R, Manh Nguyen C, Altisent O, Gibrat C, Rinfret S. Recanalization of chronic total occlusions in patients with previous coronary bypass surgery and consideration of retrograde access via saphenous vein grafts. Circ Cardiovasc Interv 2016;9: e003515. [17] Morino Y, Abe M, Morimoto T, Kimura T, Hayashi Y, Muramatsu T, et al. Predicting successful guidewire crossing through chronic total occlusion of native coronary lesions within 30 minutes: the J-CTO (Multicenter CTO Registry in Japan) score as a difficulty grading and time assessment tool. JACC Cardiovasc Interv 2011; 4:213–21. [18] Azzalini L, Ojeda S, Karatasakis A, Maeremans J, Tanabe M, La Manna A, et al. Long-term outcomes of percutaneous coronary intervention for chronic total occlusion in patients who have undergone coronary artery bypass grafting vs those who have not. Can J Cardiol 2018;34:310–8.
Please cite this article as: S.J. Wilson, C.G. Hanratty, M.S. Spence, et al., Saphenous vein graft sacrifice following native vessel PCI is safe and associated with favourable longer-term outcomes, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.01.025