Pressure wire compared to microcatheter sensing for coronary fractional flow reserve: the PERFORM study

Ali, Ziad A.; Parviz, Yasir; Brinkman, Matthew; Matsumura, Mitsuaki; Redfors, Björn; Brogno, David; Corral, Maria; Fall, Khady; Mintz, Gary S.; Stone, Gregg W.; Maehara, Akiko; Jeremias, Allen; Kirtane, Ajay J.

doi:10.4244/eij-d-18-00064

Cited by 9 publications

(7 citation statements)

References 16 publications

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“…Six studies, including stenosis-level data from 440 lesions (413 patients), were included in the final analysis (figure 2). 1 3–7 All studies compared FFR MC to FFR PW and provided scatter plots that enabled extraction of raw data. The sample size, means and SD of extracted data points were numerically identical to those reported in each study.…”

Section: Resultsmentioning

confidence: 99%

“…In all five studies where the method of drift measurement was recorded, drift was measured separately for the PW and MC. Of the four studies that presented a point estimate of signal drift,4–7 only one presented individual patient data 4. In three of these studies,5–7 no clinically significant difference in the mean level of drift between FFR MC and FFR PW was reported table 2.…”

Section: Resultsmentioning

confidence: 99%

“…Finally, MC use fibre-optic sensors, which could reduce the incidence of signal drift, a recognised problem with the piezo-electric sensor technology used in most PW. Observational studies have been published comparing the two methods with regards to FFR agreement 1 3–7. While most highlight a systematic bias in the results, more than one study reports a good agreement between the methodologies highlighting the need for further analysis.…”

Section: Introductionmentioning

confidence: 99%

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Fractional flow reserve derived from microcatheters versus standard pressure wires: a stenosis-level meta-analysis

et al. 2019

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AimsTo determine the agreement between sensor-tipped microcatheter (MC) and pressure wire (PW)-derived fractional flow reserve (FFR).Methods and resultsStudies comparing FFR obtained from MC (FFRMC, Navvus Microcatheter System, ACIST Medical Systems, Eden Prairie, Minnesota, USA) versus standard PW (FFRPW) were identified, and a meta-analysis of numerical and categorical agreement was performed. The relative levels of drift and device failure of MC and PW systems from each study were assessed. Six studies with 440 lesions (413 patients) were included. The mean overall bias between FFRMC and FFRPW was −0.029 (FFRMC lower). Bias and variance were greater for lesions with lower FFRPW (p<0.001). Using a cut-off of 0.80, 18 % of lesions were reclassified by FFRMC versus FFRPW (with 15 % being false positives). The difference in reported drift between FFRPW and FFRMC was small. Device failure was more common with MC than PW (7.1% vs 2%).ConclusionFFRMC systematically overestimates lesion severity, with increased bias in more severe lesions. Using FFRMC changes revascularisation guidance in approximately one out of every five cases. PW drift was similar between systems. Device failure was higher with MC.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Fractional flow reserve derived from microcatheters versus standard pressure wires: a stenosis-level meta-analysis

et al. 2019

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“…In the literature, a hypothesis exists that the fiber‐optic based pressure sensor has less drift compared with piezoresistive sensors 12 . However, until now, this hypothesis has not been well verified: while Menon et al found optical‐sensor PMC has smaller mean drift than piezoresistive PW ( p = .014), 28 Wijntjens et al, 13 Fearon et al, 14 and Ali et al 15 all reported that the mean drift of the two systems do not differ statistically ( p = .07, .66, and .38, respectively). The findings are similar when comparing the mean drift of optical‐sensor PW with piezoresistive PW 21 .…”

Section: Discussionmentioning

confidence: 99%

“…An optical‐sensor pressure microcatheter (Navvus, ACIST Medical Systems, Eden Prairie, MN, USA) accommodating any 0.014″ guidewire has been developed 12 and investigated in several clinical studies. 13 , 14 , 15 , 16 It has been shown that FFR measurement using pressure microcatheter (PMC) facilitates multiple advancement and withdrawal over any guidewire of physicians' choice. In addition, during physiological assessment for diffuse and serial lesions, the PMC enables maintaining the guidewire in place.…”

Section: Introductionmentioning

confidence: 99%

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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Prognostic value of post-percutaneous coronary intervention diastolic pressure ratio

et al. 2022

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Aim To evaluate the distribution of a generic diastolic pressure ratio (dPR) after angiographically successful percutaneous coronary intervention (PCI) and to assess its association with the 2‑year incidence of target vessel failure (TVF), defined as a composite of cardiac mortality, target vessel revascularisation, target vessel myocardial infarction and stent thrombosis. Methods The dPR SEARCH study is a post hoc analysis of the prospective single-centre FFR-SEARCH registry, in which physiological assessment was performed after angiographically successful PCI in a total of 1000 patients, using a dedicated microcatheter. dPR was calculated offline with recently validated software in a subset of 735 patients. Results Mean post-PCI dPR was 0.95 ± 0.06. Post-PCI dPR was ≤ 0.89 in 15.2% of the patients. The cumulative incidence of TVF at 2‑year follow-up was 9.4% in patients with a final post-PCI dPR ≤ 0.89 as compared to 6.1% in patients with a post-PCI dPR > 0.89 (adjusted hazard ratio [HR] for dPR ≤ 0.89: 1.53; 95% CI 0.74–3.13; p = 0.249). dPR ≤ 0.89 was associated with significantly higher cardiac mortality at 2 years; adjusted HR 2.40; 95% CI 1.01–5.68; p = 0.047. Conclusions In a real-world setting, despite optimal angiographic PCI results, 15.2% of the patients had a final post-PCI dPR of ≤ 0.89, which was associated with a higher incidence of TVF and a significantly higher cardiac mortality rate.

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Pressure wire compared to microcatheter sensing for coronary fractional flow reserve: the PERFORM study

Abstract: Introduction of the PC reduced both hyperaemic FFR and resting Pd/Pa compared with the PW alone, leading to re-classifying physiological significance to below the clinical threshold in one out of five assessments.

Cited by 9 publications

References 16 publications

Fractional flow reserve derived from microcatheters versus standard pressure wires: a stenosis-level meta-analysis

Fractional flow reserve derived from microcatheters versus standard pressure wires: a stenosis-level meta-analysis

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

Prognostic value of post-percutaneous coronary intervention diastolic pressure ratio

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