Hemodynamic Performance of Pericardial Bioprostheses in the Aortic Position

Lee, Haeju; Hwang, Ho Young; Sohn, Suk Ho; Choi, Jong-Woo; Park, Jun Bean; Kim, Kyung Hwan; Kim, Ki Bong

doi:10.5090/kjtcs.19.099

Cited by 7 publications

(6 citation statements)

References 15 publications

(33 reference statements)

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“…However, the authors deferred this finding from the conclusions because it has been recommended to evaluate the hemodynamic performance of AV prostheses at 6 months to 1 year after surgery, because several unstable factors, including BSA, anemia, inflammation, and other medical conditions, could affect early hemodynamic performance of prosthetic AV. [23][24][25] Following this, the present study was also designed to analyze the endpoints at 1 year after surgery. In the present study, the overall AVMPG, which is the primary endpoint of this trial, fulfilled the noninferiority hypothesis of the trial.…”

Section: Discussionmentioning

confidence: 99%

A Controlled Trial Comparing One-Year Hemodynamics of Two Bovine Pericardial Valves

Sohn,

Kang,

Kim

et al. 2023

Thorac Cardiovasc Surg

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Background: This randomized controlled trial was designed to compare 1-year hemodynamic performances and clinical outcomes after aortic valve replacement (AVR) using a recently introduced (the AVALUS group) and worldwide used (the CEPME group) bovine pericardial bioprostheses. Methods: Patients were screened to enroll 70 patients in each group based on a noninferiority design. The primary endpoint of the trial was the mean pressure gradient across the aortic valve (AVMPG) at 1 year after surgery. One-year echocardiographic data were obtained from 92.1% (129 of 140 patients) of the study patients. Results: There were no differences in baseline characteristics, including sex and body surface area (1.64±0.18 vs 1.65±0.15 m2) between the groups. The AVMPG on 1-year echocardiography was 14.0±4.3 mmHg and 13.9±5.1 mmHg in the AVALUS and CEPME groups, respectively (P for noninferiority =.0004). In the subgroup analyses for the respective size of the prostheses, AVMPG of the 19mm prostheses was significantly lower in the AVALUS than CEPME group (14.0±4.3 mmHg vs 20.0±4.7 mmHg, P =.012), whereas those of the other sizes were not significantly different between the two groups. There were no significant differences in the effective orifice area (1.49±0.40 cm2 vs 1.53±0.38 cm2, P =.500) or effective orifice area index (0.91±0.22 cm2/m2 vs 0.93±0.23 cm2/m2, P =.570) in all patients, or in the subgroup analysis for the 19mm prosthesis. There were no differences in 1-year clinical outcomes between the 2 groups. Conclusions: The 1-year hemodynamic and clinical outcomes of the AVALUS group were noninferior to those of the CEPME group. (NCT03796442)

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Section: Discussionmentioning

confidence: 99%

A Controlled Trial Comparing One-Year Hemodynamics of Two Bovine Pericardial Valves

Sohn,

Kang,

Kim

et al. 2023

Thorac Cardiovasc Surg

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“…The implantation technique of the Magna Ease valve, which varied among surgeons, might also confound the hemodynamic outcomes. Third, the present study only reported early hemodynamic profiles, whereas it has been recommended to evaluate the hemodynamic performance of AV prostheses at 6 months to 1 year after surgery ( 33 - 35 ). Also, data regarding the long-term durability beyond 5 years and incidence of structural valve deterioration, which would be of great importance, was not investigated.…”

Section: Discussionmentioning

confidence: 99%

Rapid deployment versus its conventional counterpart in aortic valve replacement: comparison of early hemodynamic outcomes

Sohn¹,

Kim²,

Kang³

et al. 2023

J Thorac Dis

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Background Edwards Intuity is designed for rapid deployment based on the structure of Magna Ease. This study was conducted to compare early hemodynamic performance between the two valves. Methods Patients who underwent aortic valve replacement (AVR) using Edwards Intuity or Carpentier-Edwards PERIMOUNT Magna Ease in our institution from June 2016 to July 2021 were enrolled. Intuity valve was used in 215 patients, and Magna Ease valve was used in 198 patients, respectively. Early postoperative echocardiographic data were available in 99.0% (409/413) of the patients. The transvalvular mean pressure gradient, effective orifice area, and effective orifice area index were compared between the valves stratified by prosthesis size. Results There were no differences in the proportion of female patients or body surface area between the groups. Mean pressure gradient on early postoperative echocardiography was significantly lower in Intuity valve than Magna Ease valve for 19, 21, 23, and 25 mm valves (15.5±5.0 vs. 20.8±9.1 mmHg, P=0.004; 12.7±4.2 vs. 15.6±5.3 mmHg, P=0.001; 11.5±3.3 vs. 13.4±5.8 mmHg, P=0.034; and 9.9±3.1 vs. 12.3±4.0 mmHg, P=0.029; respectively). Effective orifice area was larger in Intuity valve than Magna Ease valve for 19 mm valve (1.45±0.38 vs. 1.19±0.28 cm 2 , P=0.002), and effective orifice area index was also larger in Intuity valve than Magna Ease valve for 19 mm valve (0.96±0.26 vs. 0.80±0.20 cm 2 /m 2 , P=0.005). Early clinical outcomes, including operative mortality and postoperative complications, demonstrated no significant differences between the groups. Conclusions Edwards Intuity demonstrated superior early hemodynamic performance compared with Magna Ease in a size-by-size comparison, and this superiority was more definite for small prostheses.

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“…The values for the effective orifice area (EOA) for each type of prosthesis implanted during the study period were retrieved from companies' publications [16,17], observational studies [18][19][20], or administrative documents [21]. The indexed EOA (iEOA = EOA/body surface area) was calculated and used to define the degree of expected prosthesis-patient mismatch [22], which was classified as absent if iEOA > 0.85 cm 2 /m 2 , moderate for values between 0.65 cm 2 /m 2 and 0.85 cm 2 /m 2 , and severe if iEOA < 0.65 cm 2 /m 2 .…”

Section: Definitionsmentioning

confidence: 99%

Improved Early Outcomes in Women Undergoing Aortic Valve Interventions

Malvindi,

Bifulco,

Berretta

et al. 2023

JCM

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Surgical aortic valve replacement (SAVR) in female patients has been associated with higher mortality (up to 3.3–8.9%) and postoperative complication rates when compared with their male counterparts. In recent years, TAVI has been shown to provide a greater benefit than SAVR in women. We sought to assess the early outcomes of the contemporary aortic valve intervention practice (surgical and transcatheter) in patients referred to our cardiac surgery unit. The data of consecutive patients who underwent isolated aortic valve intervention for aortic valve stenosis during the 2018–2022 period were retrieved from our internal database. Several preoperative, intraoperative, and postoperative variables were analyzed, including the predicted risk of a prosthesis–patient mismatch. Nine hundred and fifty-five consecutive patients—514 women and 441 men—were included. Among them, 480 patients—276 female and 204 male—received a transcatheter procedure, and 475—238 women and 237 men—had conventional SAVR. The women were older and had higher EuroSCORE II, while the male patients presented a higher incidence of cardiovascular comorbidities. There was no difference in mortality or major postoperative complication rates after either the surgical or transcatheter procedures between the female and male populations. The availability and targeted use of different techniques and technologies have enabled the safe and effective treatment of female patients treated for severe symptomatic aortic valve stenosis with similar results when compared with their male counterparts.

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Hemodynamic Performance of Pericardial Bioprostheses in the Aortic Position

Cited by 7 publications

References 15 publications

A Controlled Trial Comparing One-Year Hemodynamics of Two Bovine Pericardial Valves

A Controlled Trial Comparing One-Year Hemodynamics of Two Bovine Pericardial Valves

Rapid deployment versus its conventional counterpart in aortic valve replacement: comparison of early hemodynamic outcomes

Improved Early Outcomes in Women Undergoing Aortic Valve Interventions

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