A head‐to‐head comparison of three coronary fractional flow reserve measurement technologies: The fractional flow reserve‐device study

Beygui, Farzin; Lemaître, Adrien; Bignon, Mathieu; Wain-Hobson, Julien; Briet, Clément; Ardouin, P; Sabatier, Rémi; Parienti, Jean‐Jacques; Blanchart, Katrien; Roule, Vincent

doi:10.1002/ccd.28433

Cited by 7 publications

(9 citation statements)

References 21 publications

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“…In this study, MEMS‐PMC has the same device success rate as PW (97.5 vs. 96.3%, p = .43), and all MEMS‐PMCs successfully crossed the lesions. The success results of optical‐sensor PMC are similar: 97% (94/97, CONTRACT), 30 97% (237/245, ACIST‐FFR), 14 97% (972/1000, pre‐PCI, FFR‐SEARCH) 11 and 94% (31/33, FFR‐DS) 29 . During the study, no thrombus was observed on the devices in any of the enrolled 242 patients, nor was there any other serious adverse event.…”

Section: Discussionmentioning

confidence: 68%

“…The success results of optical‐sensor PMC are similar: 97% (94/97, CONTRACT), 30 97% (237/245, ACIST‐FFR), 14 97% (972/1000, pre‐PCI, FFR‐SEARCH) 11 and 94% (31/33, FFR‐DS). 29 During the study, no thrombus was observed on the devices in any of the enrolled 242 patients, nor was there any other serious adverse event. Thus, the MEMS‐PMC is safe to use for routine clinical FFR measurement.…”

Section: Discussionmentioning

confidence: 87%

“… 21 As of the drift with clinical significance, Menon et al reported a numerically lower drift occurrence rate for PMC without p‐value (PMC: 13%; PW: 33%), while Wijntjens et al 13 and Fearon et al 14 showed the difference was not statistically significant ( p = .76 and .10, respectively). Recently, Beygui et al found the optical‐sensor based PMC has a statistically lower mean drift than the optical‐sensor based PW, 29 implying the PW seems more vulnerable to drift. 29 In our study, we found that MEMS‐PMC has: (a) similar mean drift as the PW ( p = .263, Table 2 ), and (b) statistically less clinically significant drift (CSD) rate than the PW ( p = .014, Table 2 ).…”

Section: Discussionmentioning

confidence: 99%

“…Recently, Beygui et al found the optical‐sensor based PMC has a statistically lower mean drift than the optical‐sensor based PW, 29 implying the PW seems more vulnerable to drift. 29 In our study, we found that MEMS‐PMC has: (a) similar mean drift as the PW ( p = .263, Table 2 ), and (b) statistically less clinically significant drift (CSD) rate than the PW ( p = .014, Table 2 ). One reason for PW's higher CSD rate may be due to the dis‐ and re‐connection of the PW electrical end during procedures, which is not uncommon in daily clinical practice while using PW.…”

Section: Discussionmentioning

confidence: 99%

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Multicenter clinical evaluation of a piezoresistive‐MEMS‐sensor rapid‐exchange pressure microcatheter system for fractional flow reserve measurement

Yang

Dong

et al. 2021

Cathet Cardio Intervent

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Objectives This multicenter, prospective clinical study investigates whether the microelectromechanical‐systems‐(MEMS)‐sensor pressure microcatheter (MEMS‐PMC) is comparable to a conventional pressure wire in fractional flow reserve (FFR) measurement. Background As a conventional tool for FFR measurement, pressure wires (PWs) still have some limitations such as suboptimal handling characteristics and unable to maintain the wire position during pullback assessment. Recently, a MEMS‐PMC compatible with any 0.014″ guidewire is developed. Compared with the existing optical‐sensor PMC, this MEMS‐PMC has smaller profiles at both the lesion crossing and sensor packaging areas. Methods Two hundred and forty‐two patients with visually 30–70% coronary stenosis were enrolled at four centers. FFR was measured first with the MEMS‐PMC, and then with the PW. The primary endpoint was the Bland–Altman mean bias between the MEMS‐PMC and PW FFR. Results From the 224‐patient per‐protocol data, quantitative coronary angiography showed 17.9% and 55.9% vessels had diameter < 2.5 mm and stenosis >50%, respectively. The two systems' mean bias was −0.01 with [−0.08, 0.06] 95% limits‐of‐agreement. Using PW FFR≤0.80 as cutoff, the MEMS‐PMC per‐vessel diagnostic accuracy was 93.4% [95% confidence interval: 89.4–96.3%]. The MEMS‐PMC's success rate was similar to that of PW (97.5 vs. 96.3%, p = .43) with no serious adverse event, and its clinically‐significant (>0.03) drift rate was 43% less (9.5 vs. 16.7%, p = .014). Conclusions Our study showed the MEMS‐PMC is safe to use and has a minimal bias equal to the resolution of current FFR systems. Given the MEMS‐PMC's high measurement accuracy and rapid‐exchange nature, it may become an attractive new tool facilitating routine coronary physiology assessment.

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Section: Discussionmentioning

confidence: 68%

Section: Discussionmentioning

confidence: 87%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Multicenter clinical evaluation of a piezoresistive‐MEMS‐sensor rapid‐exchange pressure microcatheter system for fractional flow reserve measurement

Yang

Dong

et al. 2021

Cathet Cardio Intervent

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“…In this issue of Catheterization and Cardiovascular Interventions , Beygui et al measured FFR on 32 lesions with 50–75% stenoses in patients with stable ischemic heart disease, and compared measurements obtained using three different systems: PressureWire (Saint Jude Medical, St. Paul, MN), Comet wire (Boston Scientific, Plymouth, MN), and Navvus microcatheter (ACIST, Eden Prairie, MN) 3 . The study design included the use of intracoronary adenosine to achieve maximal hyperemia, measurements of FFR with each device alone and in combination with another device, and assessment of pressure drift.…”

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confidence: 99%

Invasive fractional flow reserve: Which technology is best?

Safian

2020

Cathet Cardio Intervent

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wileyonlinelibrary.com/journal/ccd 95-98% concordance among different systems measuring NHPR and is higher than the 85-90% concordance between FFR, NHPR, and FFRct. 4 However, despite statistical differences in concordance between FFR and NHPR, clinical outcomes are strikingly similar. Second, although FFR is considered the gold standard, it is frequently tarnished by adenosine, due to individual variations in timing and magnitude of vasodilator response, limited application to diffuse disease or sequential stenoses, side effects (flushing, dyspnea, bradycardia, and heart block), and its susceptibility to errors in various clinical and anatomic settings (left main disease, presence of collaterals, extent of myocardial scar, and high right atrial pressure). Third, pressure drift and damped guiding catheter pressure can lead to false-positive and false-negative FFR measurements in 10-20% of measurements, respectively 5 ; similar pressure disturbances may apply to NHPR as well. Accordingly, many interventional cardiologists are less concerned about which FFR system to use as all share the limitations related to adenosine, and there seems to be growing interest in the use of NHPR as adenosine is not required. In addition to obviating the need for adenosine, NHPR is better suited than FFR for assessment of diffuse disease and serial lesions, and for localizing specific sites of ischemia.An incremental approach relying on NHPR for most lesions and a rapid pivot to FFR for ambiguous lesions may emerge as the preferred method for invasive assessment of lesion-specific ischemia.

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Validation of novel 3‐dimensional quantitative coronary angiography based software to calculate fractional flow reserve post stenting

Masdjedi¹,

Balbi²,

Nuis³

et al. 2020

Catheter Cardiovasc Interv

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Objectives To validate novel dedicated 3D‐QCA based on the software to calculate post PCI vessel‐FFR (vFFR) in a consecutive series of patients, to assess the diagnostic accuracy, and to assess inter‐observer variability. Background Low post percutaneous coronary intervention (PCI) fractional flow reserve (FFR) predicts future adverse cardiac events. However, FFR assessment requires the insertion of a pressure wire in combination with the use of a hyperemic agent. Methods FAST POST study is an observational, retrospective, single‐center cohort study. One hundred patients presenting with stable angina or non ST‐elevation myocardial infarction, who underwent post PCI FFR assessment using a dedicated microcatheter were included. Two orthogonal angiographic projections were acquired to create a 3D reconstruction of the coronary artery using the CAAS workstation 8.0. vFFR was subsequently calculated using the aortic root pressure. Results Mean age was 65±12 years and 70% were male. Mean microcatheter based FFR and vFFR were 0.91±0.07 and 0.91±0.06, respectively. A good linear correlation was found between FFR and vFFR (r = 0.88; p <.001). vFFR had a higher accuracy in the identification of patients with FFR values <0.90, AUC 0.98 (95% CI: 0.96‐1.00) as compared with 3D‐QCA AUC 0.62 (95% CI: 0.94‐0.74). Assessment of vFFR had a low inter‐observer variability (r = 0.95; p <.001). Conclusion 3D‐QCA derived post PCI vFFR correlates well with invasively measured microcatheter based FFR and has a high diagnostic accuracy to detect FFR <0.90 with low inter‐observer variability.

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A head‐to‐head comparison of three coronary fractional flow reserve measurement technologies: The fractional flow reserve‐device study

Cited by 7 publications

References 21 publications

Multicenter clinical evaluation of a piezoresistive‐MEMS‐sensor rapid‐exchange pressure microcatheter system for fractional flow reserve measurement

Multicenter clinical evaluation of a piezoresistive‐MEMS‐sensor rapid‐exchange pressure microcatheter system for fractional flow reserve measurement

Invasive fractional flow reserve: Which technology is best?

Validation of novel 3‐dimensional quantitative coronary angiography based software to calculate fractional flow reserve post stenting

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