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Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3840_Библиотеки_им_академика_М_И_Перельмана

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68
LIM AND KOO
the FFR-guided decision-making approachto stenting (i.e., stents only placed in lesions with an FFR <0.80)ascompared toan approach relyingonly onangiography (i.e.,stents placed in lesions with a >50% stenosis). After one year of follow-up, the FFR-guided group had a significantly lower MACE rate. Thus, even in complex patients, FFR can be used to direct decision making in the cath lab.
Besides confirmingprevious studies showing low subsequentevent rates in thosepatients in whom PCI was not performed, the FAME study gave considerable credence for defining the ischemic threshold for performing PCI as an FFR of 0.80 or less. Previous to this study, validation studieshad shown thata value of 0.75 was highlycorrelative with ischemiadetection in noninvasive studies, but there was a “gray-zone” that allowed for ischemia to be present up to an FFR of 0.80 if the patient had significant left ventricular hypertrophy. FAME has shown that an operator can implement an FFR ischemic cut-off of 0.80 to ensure that no false-negative FFR lesions are undetected and still have a dataset supporting excellent clinical outcomes. That being said, the best pure cut-off value to correlate with an ischemic-producing lesion remains an FFR <0.75.
DETERMINING THE SIGNIFICANCE OF SB OSTIAL LESIONS
The precise determination of ostial lesion severity by angiography has proven to be difficult due to angulation, branch overlap, and imaging artifacts. This difficulty is demonstrated by the need for additional angulated radiographic views, and at times, cannot be resolved despite the angiographer’s best efforts. Fundamentally, angiographic guidance for percutaneous treatment of a bifurcation involves at least the ostium of the SB and, in the case of a distal left main, the ostia of the LAD and LCx.
Studies have also evaluated the utility of intravascular ultrasound (IVUS) to help guide decision making in the cath lab. Given the previously stated limitations of the ability to fully visualize bifurcation lesions with angiography alone it is not surprising that IVUS has proven useful in providing high-quality quantitative and qualitative measures of plaque burden at bifurcation lesions. A recent case series showed that the extent of plaque burden at the SB ostium (as determined by IVUS) predicts the incidence of SB closure as compared to those bifurcations in which the plaque was exclusively in the MV (6). This finding suggests that if the operator suspects a high probability that the SB will eventually require stenting anyway, then why not elect for a two-stent strategy at the start?
Diverting from the provisionalSB stent approach could beconsidered if thepatient would be left with significant angina following the procedure. Although IVUS can show the location of plaque, its ability to assess the physiologic significance of the plaque has only been shown in the proximal or mid segments of main epicardial vessels (7). Furthermore, seeing larger plaque burdens within the coronary tree before stenting a bifurcation lesion may prompt more oper­ators to utilize a dual-stenting approach and increase the overall complexity of the procedure. Increasing the complexity ofan intervention would be warrantedif provento provideimproved outcomes, and as discussed in other chapters of this text, this is yet to be proven.
Physiologic assessment of the SB with FFR would alert the operator to the presence of an ischemia causing SB lesion and potentially influence the treatment by preferentially utilizing a two-stent strategy, especially when there appears to be angiographic disease in the SB. We have previously shown (8) that the angiographic specificity is quite poor in predicting the significance of ostial SBlesions as comparedto FFR. These data showed that ostialangiographic lesions of less than 70% were never associated with an ischemic FFR. For those ostial lesions of 70% or greater, 20% were associated with a physiologically significant lesion which would be responsible for ischemia. Prebifurcation assessment in this manner may allow the operator to maximize the opportunity to treat bifurcations with a provisional strategy.
FFR UTILITY IN ASSESSING THE NEED TO TREAT AN OSTIAL SB LESION
A 64-year-old woman presents to the hospital with recurrent atypical chest discomfort. She has a nondiagnostic electrocardiogram,showing no T-wave or ST-segment abnormalities consistent with ischemia, and has negative troponins. She undergoes an adenosine perfusion stress test that revealed normal left ventricular function and a small, mild anterior reversible perfusion
PHYSIOLOGIC GUIDANCE OF PROVISIONAL STENTING IN CORONARY BIFURCATION LESIONS
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(A) (B)
Figure 1 Coronary angiography in the RAO caudal (A) and LAO (B) projections demonstrating a lesion in the ostium of the circumflex coronary artery.
69
defect consistent with ischemia. She then underwent diagnostic angiography to evaluate her coronary anatomy. Angiograms [Fig. 1(A) and 1(B)] showed no angiographic stenoses within the LAD or RCA, but suggested a narrowing in the ostium of the circumflex. Although the patient does have atypical chest discomfort and, at worst, single-vessel disease, the question of whether this lesion is responsible for her symptoms remains unclear. To answer this question, FFR was performed by advancing a pressure wire into the circumflex through a guide catheter after intravenous anticoagulation was given. Intravenous adenosine (140 ␮g/kg/min IV) was infused and the FFR of the circumflex was found to be 0.89. This value is clearly above the ischemic threshold and, thus, the lesion was left untreated and the patient was discharged.
FFR-Guided Provisional Stenting: Why This Approach Should Be Routinely Used?
A provisional stent strategy remains the preferable approach for most patients with bifurcation lesions who are similar to those enrolled in the clinical trials (patients with moderate and focal lesions in the SB ostium). However, the steps that follow the placement of the stent in the MV are not universally agreed upon. Basically, the operator must make a decision regarding the need for dilation of the ostium of the SB and, subsequently, whether the SB needs to be stented. This decision process revolves around whether the ostium of the SB is compromised, much like the discussion in the previous section. The operator relies on the angiogram of the bifurcation to make this decision, but the angiographic ability to define significance of an obstruction in a “jailed” SB is more challenging because the metal stent struts provide more distortion to the picture.
This decision appears strikingly similar to the discussion of the significance of an ostial SB—one in which the angiogram was not ashelpful asone wouldwant. Furthermore,the overall goal for treating the patient remains the same: to abolish all coronary stenoses responsible for ischemia. Thus, it is only logical that FFR could be utilized at this step to guide further therapy or allow the operator to end the procedure with confidence.
The bestcollection of datato support theassessment of FFRin “jailed” SBsis that collected by Koo et al. (9). In a group of 94 “jailed” SBs, FFR was measured and compared to quantita­tive coronary angiographic assessment of the SB. Although there was a significant correlation between these two parameters (r =−0.41, p < 0.001), the variability of the points suggests little accuracy of QCA to predict a positive FFR (Fig. 2). Of those lesions that were 90% or greater, only 14 out of 25 had FFR values <0.75, demonstrating the inability of angiography to predict “jailed” SB lesion severity.
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1.0
.9
LIM AND KOO
r = −0.41 p < 0.001
.8
.7
Fractional flow reserve
.6
.5
40
50 60 70
80 90 100
Percent stenosis (%)
Figure 2 Correlation between fractional flow reserve and angiographic lesion severity of the jailed side branch.
Source
: Adapted from Ref. 9.
The true mark of a useful strategy in coronary intervention, however, is not whether a lesion is physiologically or angiographically significant, but whether the clinical outcome is acceptable for a given strategy. The same group evaluated a strategy of MV stenting followed by assessment of the “jailed” SB by FFR (10). The SB was subsequently treated if an abnormal FFR (<0.75)was found. Ninety-one patients with bifurcation lesions were treated in this manner and then followed forsix months. Only 30%of all “jailed” SB lesions were foundto have an FFR <0.75 in this patient population with 96% of all SBs able to be accessed successfully with the pressure wire. The SB lesions that had an FFR <0.75 underwent further therapy with “kissing” balloon angioplasty, resulting in a follow-up FFR of these SBs >0.75 in 92% of them. Six-month follow-up in these patients found a 48% binary restenosis (defined as angiographic stenosis >75%) of the SBs. However, when these stenoses were assessed by FFR, only 8% had a value less than 0.75. Furthermore, TVR was only required in 5 of these 91 patients over the follow-up period.
These data repeatedly demonstrate that angiography tends to overestimate the degree of stenosis present in ostial SB lesions. When further therapy of the SB is restricted to those patients with physiologically significant SB narrowing after MV stenting, excellent clinical outcomes are achieved. Thus, FFR-guided decision making regarding further treatment of the SB after the placement of an MV stent simplifies not only the decision-making process but also the interventional procedure for the patient while providing excellent discriminatory capability of FFR-guided provisional stenting.
Limitations to Generalizability
Although the use of FFR-guided decision making in treatment of bifurcation lesions is theo­retically appealing, there are two issues that need to be addressed before this approach can be recommended for routine use:
1. Is the current FFR wire technology versatile enough to be used successfully in the majority
of unselected patients with jailed SBs?
Although Koo and colleagues (9)have reported a success rate of 97% in crossing jailed SBs with the FFR wire, patients in this study may represent a lower level of bifurcation lesions complexity. This is confirmed by the fact that two-third of patients in this report had a class (1–2) bifurcation morphology and the SB ostial lesions were focal (mean length
PHYSIOLOGIC GUIDANCE OF PROVISIONAL STENTING IN CORONARY BIFURCATION LESIONS
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6 mm) and only of moderate severity (%DS = 45%). Success in wiring these lesions cannot be generalized to more severe lesions with more complex morphology.
2. Is the clinical outcome of patients undergoing FFR-guided provisional stenting better than that of patients undergoing angiography-guided provisional stenting?
Although the FAME study demonstrated that FFR-guided multivessel intervention is superior to angiography-guidedmultivessel intervention, this data cannot be automatically generalized to intervention on side branches. The current data certainly does not support this generalization. In the first report by Koo et al. (9), there was no comparative control arm. In the second Koo report the outcome of patients undergoing FFR-guided provisional stenting was not better than a historical group of patients who underwent angiography­guided provisional stenting (10). Moreover, the NORDIC study, which included similar patients to the study by Koo (i.e., bifurcations with moderate and focal disease in the side branches), showed very low rate of crossover to stenting in the angiography-guided provisional stenting arm and equivalent outcome to double stenting.
On the basis of these data, how canwe justify adding thetime andthe cost of usingFFR to guide provisional stenting without proving that it provides superior outcome to angiographic­guided provisional stenting? Until a randomized trial proves this point, this approach should only be used selectively.
CASE EXAMPLES
Case #1
A 58-year-old man presents to the catheterization lab after being admitted to the hospital with unstable angina.He undergoesa precatheterization stress test, which showedanterior ischemia, and was found to have an LAD lesion, which was deemed to be significant [Fig. 3(A)].The LAD is treated with a stent, “jailing” the diagonal branch that arises in the same region as the lesion. After the stent was placed, routine angiography shows a “pinch” to the ostium of the diagonal branch [Fig. 3(B)]. The operators weigh the option of wiring the diagonal and performing kissing balloon angioplastybut instead, optto wire thediagonal with apressure wireand measure FFR.
Figure 3 (A) Coronary angiographyin the RAO cranialprojection showinga significantlesion in the LAD involving a diagonal branch. (B) Coronary angiography following stent placement in the LAD showing impingement of the diagonal branch.
(B)(A)
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LIM AND KOO
With intravenous adenosine hyperemia, the FFR of the diagonal branch was 0.85. The operators then removed the wires, and the patient was sent back to the floor without further angioplasty.
Case #2
A 70-year-old man undergoes diagnostic angiography secondary to unstable angina. He is found to have serial lesions in his LAD, one before and one after a sizeable diagonal branch [Fig. 4(A)]. Baseline FFR is performed in the LAD and diagonal to getmore data for planning of the interventional strategy, and it is found that the FFR in the LAD is 0.71 and in the diagonal it is 0.78. This FFR data indicates that the two serial lesions in the LAD are in fact physiologically significant (FFR = 0.71). However, the diagonal FFR of 0.78 is most likely reflective of the LAD lesion prior to the take-off of the branch and, therefore, the operator elects to stent the LAD with a long stent covering both lesions and “jailing” the diagonal (this stent is deployed over
(B)(A)
(D)(C)
Figure 4 (A) Coronary angiography in the RAO cranial projection demonstrating serial LAD lesions before and after a large diagonal branch. (B and C) Follow-up angiography in the RAO and LAO projections, showing that the diagonal branch has an angiographic “pinch” after it is jailed and a pressure wire in the diagonal. (D) Final RAO angiography.
PHYSIOLOGIC GUIDANCE OF PROVISIONAL STENTING IN CORONARY BIFURCATION LESIONS
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the pressure wire used to FFR the LAD). Subsequent angiography demonstrates a “pinch” in the ostial diagonal that did not seem to be present prior to the stent placement [Fig. 4(B)]. Repeat FFR assessment [Fig. 4(C)] is performed by advancing a pressure wire through the LAD stent struts and into the diagonal. With adenosine-induced hyperemia, the diagonal FFR is
0.71. The LAD–diagonal bifurcation is then treated with the inflation of balloons in a “kissing” fashion over the two pressure wires that are in the LAD and diagonal. Follow-up FFR is then performed in the LAD (0.87) and the diagonal (0.83) and proves that there is no physiologically significant obstruction to coronary blood flow left at the site [Figure 4(D) shows the final angiogram]. This case shows not only the ability of the ostial “pinch” seen on the post-stent angiogram to sometimes be physiologically significant, but also the ability for an operator to perform a bifurcation procedure working over the coronary pressure wire (in this case, two pressure wires). Of note, however, because of the pressure sensor housed within the wire and the hydrophilic coating that is now on the shaft of commercially available pressure wires, it is not recommended to entrap one ofthese wires left in aside branch with a mainbranch stent. The preferred technique would be to leave a workhorse wire in the branch instead of the pressure wire or to remove the pressure wire before deploying the main branch stent.
One may ask about finishing the case with a diagonal FFR of only 0.83? While this value represents that there indeed is a residual stenosis within the diagonal branch, it is above the ischemic threshold and, therefore, should not result in symptoms for the patient. However, operators are acutely aware of the potential for restenosis of the ostial side branch, especially when it has beentreated by a balloon inflation.So, is the likelihoodof restenosis of this diagonal branch higher with an FFR of 0.83 than it would be if the value was greater or the side branch was stented? There is no available data to answer this question and it becomes an operator decision, weighing the increased complexity of a two-stent procedure with the available data supporting the benefit of stenting the side branch.
Case #3
A 73-year-old woman is found to have a lesion in her circumflex, just after a large OM branch [Fig. 5(A)]. FFR assessment of the OM branch was performed initially, indicating that there was no baseline physiologic gradient (FFR =0.98). The LCx wasthen wired and stented in a manner that “jailed” the large OM branch [Fig. 5(B)]. The OM branch was then rewired with theoriginal pressure wire (which was removed while the LCx was treated) and FFR was measured and found to be 0.98, identical to the baseline value. No further treatment was performed, and the final angiogram is shown in Figure 5(C). This case demonstrates that the plaque burden in this bifurcation was likely confined distal to the OM branch and the stenting of this vessel did not change the geometry of the OM take-off enough to cause any physiologic affect on blood flow. In our experience,it is an extremely rare occurrence that a jailedside-branch cannot be accessed with a pressure wire. We place a double-bend on the pressure wire (a distal 50–60 degrees bend and a more proximal 40 degrees bend), wire themain vessel so that thetip of the wire is beyond the side branch, and then pull the wire back while torquing the tip toward the ostium of the side branch. Occasionally, subtle changes in the bend are necessary when the initial curvature does not access the branch vessel.
Case #4
A 57-year-old man is found to have a complex series of lesions within his LCx and large first OM branch [Fig. 6(A)]. The mid-OM lesion is seen at a branch point in the vessel that the operator intends to stent and then there is an irregular nature to the LCx–OM bifurcation that the operator also intends to stent. Working distal to proximal, the OM lesion is stented and the side branch off of the main OM is felt to be too small to require subsequent treat­ment. The proximal OM is then stented, with the stent starting in the LCx proper, thereby “jailing” the AV-LCx. Subsequent angiography [Fig. 6(B)] demonstrates a “pinch” in the ostium of the AV-LCx. A pressure wire is then directed through the stent struts and into the distal AV-LCx, intravenous adenosine is given, and the FFR of this branch was found to be 0.83. Although not normal, thisvalue is above the ischemicthreshold and theoperator elected to per­form a final angiogram and end the procedure at this point with a successful result [Fig. 6(C)]. As in previous cases, the reader should note that lesions that occur in “jailed” side branches are
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LIM AND KOO
(B)(A)
Figure 5 (A) Coronary angiography in the RAO caudal projection demonstrating a severe stenosis in the circumflex artery that appears to arise distal to a large OM branch. (B) Follow-up angiography after the circumflex is stented, showing a change in the take-off angle of the branch without severe stenosis. (C) Final angiography prior to the completion of the procedure.
not usually associated with a physiologically significant stenosis, despite their disconcerting angiographic appearance.
Case #5
A 53-year-old man is found to have a subtotal occlusion of the proximal LAD [Fig. 7(A)]. The operator elects to wire the LAD, which is accomplished easily with a hydrophilic wire, and the vessel is subsequently ballooned and stented [Fig. 7(B)]. Subsequent angiography demonstrates that there is a moderately sized diagonal branch that was “jailed” by the LAD stent, and the ostium appears to be significantly obstructed by angiography [Fig. 7(C)]. As previously described, a pressure wire is placed into the LAD and across the stent struts into the diagonal branch [Fig. 7(D)]. FFR is performed andis foundto be 0.76. Atthis point, the operator
(C)
PHYSIOLOGIC GUIDANCE OF PROVISIONAL STENTING IN CORONARY BIFURCATION LESIONS
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(B)(A)
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Figure 6 (A) Coronary angiography in the RAO caudal projection demonstrating multiple lesions within the
circumflex and first obtuse marginal branch. (B) Angiogram after stenting across the AV-circumflex and into the OM branch. (C) Final angiography.
decides to further treat the bifurcation with kissing balloons in the LAD and in the diagonal (over the pressure wire). After removal of the balloons, follow-up FFR of the diagonal branch becomes 0.93 and the procedure is completed [Fig. 7(E)]. This case shows that even when a side branch is not readily apparent on initial angiograms, its appearance after main branch stenting can be handled in a similar manner. Performing kissing balloon inflations over a pressure wire does not require any specialtechniques and does not compromisethe wire to be able to perform subsequent FFRmeasurements. Follow-upFFR in theside branch becoming nonphysiologically significant is a finding that we utilize to avoid stenting the side branch. In our experience, the inability to“normalize” an FFR above theischemic threshold ismost often related to dissections arising in the ostia of the side branch and is the sign that a side branch stent needs to be placed.
Additional case examples that illustrate how FFR can be utilized in bifurcation stenting are shown inFigures 8–11. The combinationof IVUS andFFR to treatan LAD lesionis shown in Figure 8. The case in Figure 9 shows an example of patient with a left main lesion treated with
(D)(C)
(B)(A)
(D)(C)
(E)
Figure 7 (A) Coronary angiography in the RAO caudal projection showing a subtotal occlusion of the LAD. (B) Stent placement in the LAD. (C) LAO cranial angiogram demonstrating a stenosis in a “newly discovered” diagonal branch. (D) Pressure wire in the diagonal branch before measuring FFR. (E) Final angiogram.
MLD: 1.8 mm
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MLA: 3.0 mm
2
MLD: 1.8 mm MLA: 3.1 mm
2
(A)
Mid-LAD
Lt Main
Cypher 3.5 ×
13
(B)
(C)
Figure 8 ( scan ( intravascular ultrasound, minimal lumen area was 3.0 mm
See color insert
left
). Angiogram showed the stenoses located at the mid-LAD and proximal LAD bifurcation segments. By
)(A) A 57-year-old man was admitted due to the abnormality in a radionuclide
2
at mid-LAD and 3.1 mm2at LAD ostium. (B) FFR at distal LAD was 0.69. A significant pressure step up was found only at a LAD ostial lesion in a pressure pull-back curve (
green line
). Therefore, additional stent was implanted at the LAD ostium. (C) A radioisotope scan six
months after stent implantation shows no perfusion defect.