This real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (IN.PACT Global Clinical Study; NCT01609296).

Background: The non-invasive estimation of aortic systolic (aoSBP) and pulse pressure (aoPP) is achieved by a great variety of devices, which differ markedly in the: 1) principles of recording (applied technology), 2) arterial recording site, 3) model and mathematical analysis applied to signals, and/or 4) calibration scheme. The most reliable non-invasive procedure to obtain aoSBP and aoPP is not well established.Aim: To evaluate the agreement between aoSBP and aoPP values invasively and non-invasively obtained using different: 1) recording techniques (tonometry, oscilometry/plethysmography, ultrasound), 2) recording sites [radial, brachial (BA) and carotid artery (CCA)], 3) waveform analysis algorithms (e.g., direct analysis of the CCA pulse waveform vs. peripheral waveform analysis using general transfer functions, N-point moving average filters, etc.), 4) calibration schemes (systolic-diastolic calibration vs. methods using BA diastolic and mean blood pressure (bMBP); the latter calculated using different equations vs. measured directly by oscillometry, and 5) different equations to estimate bMBP (i.e., using a form factor of 33% (“033”), 41.2% (“0412”) or 33% corrected for heart rate (“033HR”).Methods: The invasive aortic (aoBP) and brachial pressure (bBP) (catheterization), and the non-invasive aoBP and bBP were simultaneously obtained in 34 subjects. Non-invasive aoBP levels were obtained using different techniques, analysis methods, recording sites, and calibration schemes.Results: 1) Overall, non-invasive approaches yielded lower aoSBP and aoPP levels than those recorded invasively. 2) aoSBP and aoPP determinations based on CCA recordings, followed by BA recordings, were those that yielded values closest to those recorded invasively. 3) The “033HR” and “0412” calibration schemes ensured the lowest mean error, and the “033” method determined aoBP levels furthest from those recorded invasively. 4) Most of the non-invasive approaches considered overestimated and underestimated aoSBP at low (i.e., 80 mmHg) and high (i.e., 180 mmHg) invasive aoSBP values, respectively. 5) The higher the invasively measured aoPP, the higher the level of underestimation provided by the non-invasive methods.Conclusion: The recording method and site, the mathematical method/model used to quantify aoSBP and aoPP, and to calibrate waveforms, are essential when estimating aoBP. Our study strongly emphasizes the need for methodological transparency and consensus for the non-invasive aoBP assessment.

Background The FiGARO (FFR versus iFR in Assessment of Hemodynamic Lesion Significance, and an Explanation of Their Discrepancies) trial is a prospective registry searching for predictors of fractional flow reserve/instantaneous wave‐free ratio (FFR/iFR) discrepancy. Methods and Results FFR/iFR were analyzed using a Verrata wire, and coronary flow reserve was analyzed using a Combomap machine (both Philips‐Volcano). The risk polymorphisms for endothelial nitric oxide synthase and for heme oxygenase‐1 were analyzed. In total, 1884 FFR/iFR measurements from 1564 patients were included. The FFR/iFR discrepancy occurred in 393 measurements (20.9%): FFRp (positive)/iFRn (negative) type (264 lesions, 14.0%) and FFRn/iFRp (129 lesions, 6.8%) type. Coronary flow reserve was measured in 343 lesions, correlating better with iFR (R=0.56, P <0.0001) than FFR (R=0.36, P <0.0001). The coronary flow reserve value in FFRp/iFRn lesions (2.24±0.7) was significantly higher compared with both FFRp/iFRp (1.39±0.36), and FFRn/iFRn lesions (1.8±0.64, P <0.0001). Multivariable logistic regression analysis confirmed (1) sex, age, and lesion location in the right coronary artery as predictors for FFRp/iFRn discrepancy; and (2) hemoglobin level, smoking, and renal insufficiency as predictors for FFRn/iFRp discrepancy. The FFRn/iFRp type of discrepancy was significantly more frequent in patients with both risk types of polymorphisms (endothelial nitric oxide synthase r +heme oxygenase‐1 r ): 8 patients (24.2%) compared with FFRp/iFRn type of discrepancy: 2 patients (5.9%), P =0.03. Conclusions Predictors for FFRp/iFRn discrepancy were sex, age, and location in the right coronary artery. Predictors for FFRn/iFRp were hemoglobin level, smoking, and renal insufficiency. The risk type of polymorphism in endothelial nitric oxide synthase and heme oxygenase‐1 genes was more frequently found in patients with FFRn/iFRp type of discrepancy. Registration URL: https://clinicaltrials.gov ; Unique identifier: NCT03033810.

The use of oscillometric methods to determine brachial blood pressure (bBP) can lead to a systematic underestimation of the invasively measured systolic (bSBP) and pulse (bPP) pressure levels, together with a significant overestimation of diastolic pressure (bDBP). Similarly, the agreement between brachial mean blood pressure (bMBP), invasively and non-invasively measured, can be affected by inaccurate estimations/assumptions. Despite several methodologies that can be applied to estimate bMBP non-invasively, there is no consensus on which approach leads to the most accurate estimation. Aims: to evaluate the association and agreement between: (1) non-invasive (oscillometry) and invasive bBP; (2) invasive bMBP, and bMBP (i) measured by oscillometry and (ii) calculated using six different equations; and (3) bSBP and bPP invasively and non-invasively obtained by applanation tonometry and employing different calibration methods. To this end, invasive aortic blood pressure and bBP (catheterization), and non-invasive bBP (oscillometry [Mobil-O-Graph] and brachial artery applanation tonometry [SphygmoCor]) were simultaneously obtained (34 subjects, 193 records). bMBP was calculated using different approaches. Results: (i) the agreement between invasive bBP and their respective non-invasive measurements (oscillometry) showed dependence on bBP levels (proportional error); (ii) among the different approaches used to obtain bMBP, the equation that includes a form factor equal to 33% (bMBP = bDBP + bPP/3) showed the best association with the invasive bMBP; (iii) the best approach to estimate invasive bSBP and bPP from tonometry recordings is based on the calibration scheme that employs oscillometric bMBP. On the contrary, the worst association between invasive and applanation tonometry-derived bBP levels was observed when the brachial pulse waveform was calibrated to bMBP quantified as bMBP = bDBP + bPP/3. Our study strongly emphasizes the need for methodological transparency and consensus for non-invasive bMBP assessment.

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