Clinical Short-Term Outcome and Hemodynamic Comparison of Six Contemporary Bovine Aortic Valve Prostheses

Hartrumpf, Martin; Kuehnel, Ralf-Uwe; Schröter, Filip; Haase, Robert; Laux, Magdalena; Ostovar, Roya; Albes, Johannes M.

doi:10.1055/s-0038-1676853

Cited by 8 publications

(27 citation statements)

References 22 publications

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“…Among these articles, 1,977 publications were excluded because they clearly did not fulfill the selection criteria based on the title and abstract. Full manuscripts of the remaining 47 articles were reviewed, and 8 publications (5,11,13,(15)(16)(17)(18)(19) were included in this study (Figure 1). Because two studies (11,15) were from the same multinational registry, one study (11) was selected for baseline-data and outcome analyses.…”

Section: Identification Of Studiesmentioning

confidence: 99%

“…All 8 studies were non-randomized studies (NRSs). All outcomes except AVMPG in matched valve sizes were extracted from 7 studies (5,11,13,(16)(17)(18)(19)) with 2,228 patients (RD group =842 patients and SU group =1,386 patients); the largest study included 1418 patients (RD group and SU group =407 and 1,011 patients, respectively) (11) whereas only 43 patients (RD group and SU group =27 and 16 patients, respectively) were included in the smallest study (17) (Table 1). The average or median patient age was in the 70s, and 59.4% of the patients were female.…”

Section: Study Characteristics and Patient Populationsmentioning

confidence: 99%

“…The distributions of the sizes of both RD and SU valves are described in Figure S1. (11,13,16,17,19) were graded as having an overall severe ROB due to the presence of confounding biases, because the patients' baseline characteristics were not balanced across the groups and appropriate adjustments for confounding factors were not performed. Another study (15), which was used to extract data on AVMPG in matched valve sizes, also had an overall severe ROB for the same reason.…”

Section: Study Characteristics and Patient Populationsmentioning

confidence: 99%

“…Six studies (5,11,13,16,18,19) demonstrated AVMPG after surgery, and 5 studies (5,13,16,18,19) reported the AVMPG in each valve size. One more study (15) was included in the analysis to extract data regarding AVMPG in each valve size as previously described.…”

Section: Mean Transvalvular Pressure Gradientmentioning

confidence: 99%

“…The risk of the need for PPI after AVR was drawn from 6 studies with 1,735 patients (5,11,13,16,18,19). The pooled analysis demonstrated that the risk of PPI was significantly lower in the RD group than in the SU group [RR (95% CI) =0.69 (0.50, 0.94), I 2 =0%, Figure 5].…”

Section: Risk Of the Need For Ppimentioning

confidence: 99%

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Direct comparison of rapid deployment versus sutureless aortic valve replacement: a meta-analysis

Sohn¹,

Kang²,

Kim³

et al. 2021

J Thorac Dis

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Background: This meta-analysis was conducted to compare the procedural and early outcomes of aortic valve replacement (AVR) using rapid deployment valve (RD group) versus sutureless valve (SU group). Methods: A literature search of 5 online databases was conducted. The primary outcomes were mean transvalvular pressure gradient (MPG) after AVR, the incidence of paravalvular leak (PVL) and the need for a permanent pacemaker implantation (PPI). The secondary outcomes included aortic cross-clamp (ACC) and cardiopulmonary bypass (CPB) times, early mortality and other postoperative complications, such as atrial fibrillation, bleeding reoperation and stroke.Results: Eight articles were included, and all outcomes except MPG after AVR in matched valve sizes were extracted from 7 studies (RD group =842 patients and SU group =1,386 patients). The pooled analysis demonstrated a lower MPG in the RD group than in the SU group, with mean difference (MD) of 2.64 mmHg. The pooled risk ratios of any PVL and grade ≥2 (or moderate) PVL were not significantly different between the groups; however, the incidence of PPI was significantly lower in the RD group than in the SU group, with a risk ratio of 0.69. The pooled analyses showed that the ACC and CPB times were significantly longer in the RD group than in the SU group, with weighted MDs of 8.74 (P<0.001) and 9.94 (P<0.001) minutes, respectively. The risks of early mortality and other postoperative complications were not significantly different between the groups.Conclusions: AVR using RD valve was associated with better valve hemodynamics in terms of the MPG than AVR using SU valve, and better outcomes were observed in the RD group regarding PPI. Procedural times were longer in AVR using RD valve than SU valve. Early clinical outcomes showed no difference between RD and SU valve.

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Section: Identification Of Studiesmentioning

confidence: 99%

Section: Study Characteristics and Patient Populationsmentioning

confidence: 99%

Section: Study Characteristics and Patient Populationsmentioning

confidence: 99%

Section: Mean Transvalvular Pressure Gradientmentioning

confidence: 99%

Section: Risk Of the Need For Ppimentioning

confidence: 99%

See 3 more Smart Citations

Direct comparison of rapid deployment versus sutureless aortic valve replacement: a meta-analysis

Sohn¹,

Kang²,

Kim³

et al. 2021

J Thorac Dis

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Results of Four-Stented Biological Aortic Valves and How They Compare to PARTNER-3

Rashvand

Ostovar

Schröter

et al. 2022

Thorac Cardiovasc Surg

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Objective According to our nationwide registry, total numbers of surgical aortic valve implantation (sAVR) are constantly declining, while transcathether aortic valve implantation (TAVI) indications are widened toward intermediate- and low-risk patients. So, is there still room for conventionally implanted valves? Can results compete with TAVI or will sAVR be marginalized in the near future? Methods Between 2011 and 2019, 1,034 patients (67.1% male, mean = 72.2 years) were enrolled receiving stented biological valves with or without concomitant coronary artery bypass grafting (CABG), atrial ablation, or wrapping of the ascending aorta. Odds ratios for the early and late mortality were calculated regarding comorbidities as potential risk factors. Statistical analysis was performed using SPSS. Results Overall, early mortality (EM) was 6.1%, 1-year mortality was 11.2%, and 5-year mortality was 19.9%. In low-risk patients (EuroSCORE II <4%), it was 1.0, 2.7, and 9.3%. Incidence of EM was significantly increased following decompensation, prosthetic valve, pacemaker carrier, dialysis, and pulmonary hypertension. Postoperative complications, such as systemic inflammatory response syndrome (SIRS), sepsis, multiorgan failure, hepatic failure, dialysis, gastrointestinal bleeding, and ileus, also increased EM. Late mortality was significantly increased by dialysis, hepatic cirrhosis, infected port system, aortic valve endocarditis, prosthetic valve carrier, and chronic hemodialysis. Conclusion Conventionally implanted aortic valves do well early and late. The fate of the patient is dependent on individual risk-factors. Particularly, in low-risk patients, sAVR can compete with TAVI showing overall good early, as well as late results being even superior in some important aspects such as pacemaker implantation rate. Thus, the time is yet not ripe for TAVI to take over primary indications for AVR in low-risk patient.

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5-Year haemodynamic performance of three aortic bioprostheses. A randomized clinical trial

Cruces

Carnero-Alcázar

Camargo

et al. 2023

European Journal of Cardio-Thoracic Surgery

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OBJECTIVES Carpentier Perimount Magna EaseTM (CPME), Crown PRTTM, and TrifectaTM bovine pericardial valves have been widely used worldwide. The primary end-point was to compare the haemodynamic performance quantified by in vivo echocardiogram of these 3 aortic prostheses. METHODS The “BEST-VALVE” (Comparison of 3 contemporary cardiac bioprosthesis: mid-term valve haemodynamic performance) was a single center randomized clinical trial to compare the haemodynamic and clinical outcomes of the aforementioned bioprostheses. 5 year results are assessed in this manuscript. RESULTS 154 patients were included. CPMETM (n = 48, 31.2%), Crown PRTTM (n = 51, 32.1%) and TrifectaTM (n = 55, 35.7%). Significant differences were observed between the three bioprostheses 5-years after the procedure. These haemodynamic differences were found between CPMETM and Crown PRTTM bioprostheses (Mean aortic gradient: 12.3 mmHg (IQR 7.8–17.5) for CPMETM vs 15 mmHg (IQR 10.8 - 31.9) for Crown PRTTM, p < 0.001) and between CPMETM and TrifectaTM prostheses (Mean aortic gradient: 12.3 mmHg (IQR 7.8–17.5) for CPMETM vs 14.7 mmHg (IQR 8.2–55) for TrifectaTM, p < 0.001), with a better haemodynamic performance of CPMETM. The cumulative incidence of severe structural valve degeneration was 9.5% in the TrifectaTM group at 6 years of follow-up. The 1-, 3- and 5-years survival from all-cause mortality was 91.5%, 83.5% and 74.8%, respectively (Log Rank p = 0.440). Survival from the composite event at 1-, 3- and 5-years follow-up was 92.8%, 74.6% and 59%, respectively (Log Rank p = 0.299). CONCLUSIONS We detected significant differences between the three bioprosthesis having CPMETM the best haemodynamic performance at 5 years follow-up. Clinical registration number EudraTC (European Database of Clinical Trials): 2018-001658-87. https://eudract.ema.europa.eu

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Clinical Short-Term Outcome and Hemodynamic Comparison of Six Contemporary Bovine Aortic Valve Prostheses

Cited by 8 publications

References 22 publications

Direct comparison of rapid deployment versus sutureless aortic valve replacement: a meta-analysis

Direct comparison of rapid deployment versus sutureless aortic valve replacement: a meta-analysis

Results of Four-Stented Biological Aortic Valves and How They Compare to PARTNER-3

5-Year haemodynamic performance of three aortic bioprostheses. A randomized clinical trial

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