Changing trends in aortic valve procedures over the past ten years—from mechanical prosthesis via stented bioprosthesis to TAVI procedures—analysis of 50,846 aortic valve cases based on a Polish National Cardiac Surgery Database

Bartuś, Krzysztof; Sadowski, Jerzy; Litwinowicz, Radosław; Filip, Grzegorz; Jasiński, Marek; Deja, Marek; Kuśmierczyk, Mariusz; Pawlak, Szymon; Jemielity, Marek; Jagielak, Dariusz; Hendzel, Piotr; Suwalski, Piotr; Tobota, Zdzisław; Maruszewski, Bohdan; Kapelak, Bogusław

doi:10.21037/jtd.2019.06.04

Cited by 30 publications

(32 citation statements)

References 31 publications

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“…Although mechanical valves are often recommended for younger patients because they provide superior long-term durability compared to bioprostheses, patients with mechanical valves require lifetime anticoagulation, which increases the risk of major bleeding [ 2 , 3 ]. The On-X mechanical valve, however, does offer the advantage of requiring a lower international normalized ratio of 1.5–2.0, which should reduce the risk of bleeding.…”

Section: Discussionmentioning

confidence: 99%

Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis

Bartuś

Litwinowicz

Bilewska

et al. 2020

European Journal of Cardio-Thoracic Surgery

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OBJECTIVES Long-term durability of bioprosthetic valves is predominantly limited by structural valve deterioration. RESILIA™ tissue has exhibited reduced calcification in pre-clinical and early clinical studies. This study evaluated the 5-year clinical and haemodynamic outcomes of an aortic valve with this tissue. METHODS This was a prospective, non-randomized, single-arm study of 133 patients implanted with a RESILIA aortic bioprosthesis between July 2011 and February 2013 at 2 sites in Poland. Clinical outcomes and haemodynamic performance were assessed annually for 5 years post-implant. Safety events were adjudicated by a Clinical Events Committee and echocardiographic data were assessed by an independent core laboratory. RESULTS Mean patient age was 65.3 ± 13.5 years, with 34 patients (25.6%) ≤60. The mean follow-up was 4.2 ± 1.5 years. Early (≤30 days) and late (>30 days) all-cause mortality were 2.3% (N = 3) and 3.2%/late patients-years (N = 18) respectively. Early events included thromboembolism in 3 patients (2.3%). Late valve-related events included endocarditis in 1 patient, which led to explant, and valve thrombosis in another patient. There were no events of structural valve deterioration throughout the study. At 5 years, mean gradient was 14.8 ± 7.6 mmHg and effective orifice area was 1.4 ± 0.5 cm2, a marked improvement over baseline values. All New York Heart Association class III patients and most class II patients at baseline had improved classifications at 5 years. CONCLUSIONS The bioprosthesis with RESILIA tissue demonstrated a good safety profile with excellent haemodynamic performance over 5 years of follow-up. These encouraging outcomes warrant additional investigation of this novel tissue. Clinical trial registration number NCT01651052

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Section: Discussionmentioning

confidence: 99%

Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis

Bartuś

Litwinowicz

Bilewska

et al. 2020

European Journal of Cardio-Thoracic Surgery

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“…13 University Hospital Duesseldorf, Duesseldorf, Germany. 14 Cardiac Surgery, Klinikum Nürnberg -Paracelsus Medical University, Nuremberg, Germany. 15 University Hospital Bergmannsheil, Bochum, Germany.…”

Section: Fundingmentioning

confidence: 99%

“…While mechanical valves have been the mainstay of SAVR, the use of bioprostheses for the surgical treatment of valve diseases has increased considerably over the last decade [14]. They were introduced to improve the hemodynamic performance of the valves and to reduce the risk of structural valve deterioration (SVD) [15].…”

Section: Introductionmentioning

confidence: 99%

Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement – rationale and design of the international IMPACT registry

Bakhtiary¹,

Ahmad²,

Autschbach

et al. 2021

J Cardiothorac Surg

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Background Degenerative aortic valve disease accounts for 10–20% of all cardiac surgical procedures. The impact of pre-existing comorbidities on the outcome of patients undergoing surgical aortic valve replacement (SAVR) needs further research. Methods The IMPACT registry is a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years to assess the impact of pre-existing comorbidities of patients undergoing SAVR with the INSPIRIS RESILIA aortic valve on outcomes. IMPACT will be conducted across 25 sites in Austria, Germany, The Netherlands and Switzerland and intends to enroll approximately 500 patients. Patients will be included if they are at least 18 years of age and are scheduled to undergo SAVR with the INSPIRIS RESILIA Aortic Valve with or without concomitant ascending aortic root replacement and/or coronary bypass surgery. The primary objective is to determine all-cause mortality at 1, 3, and 5 years post SAVR. Secondary objectives include cardiac-related and valve-related mortality and structural valve deterioration including hemodynamics and durability, valve performance and further clinical outcomes in the overall study population and in specific patient subgroups characterized by the presence of chronic kidney disease, hypertension, metabolic syndrome and/or chronic inflammation. Discussion IMPACT is a prospective, multicenter European registry, which will provide much-needed data on the impact of pre-existing comorbidities on patient outcomes and prosthetic valve performance, and in particular the performance of the INSPIRIS RESILIA, in a real-world setting. The findings of this study may help to support and expand appropriate patient selection for treatment with bioprostheses. Trial registration ClinicalTrials.gov identifier: NCT04053088.

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“…The increasing use of bioprostheses (MV 18%–34% and AV 16%–39%), mainly among patients older than 25 years, reflects a trend worldwide for all valve replacements, as confidence grows in the longevity of bioprostheses [ 25 ]. Bioprosthetic replacements also increased among older patients, some of whom may have undergone valve repair or PBV prior to the study period.…”

Section: Discussionmentioning

confidence: 99%

The use of cardiac valve procedures for rheumatic heart disease in Australia; a cross-sectional study 2002–2017

Bradshaw

Tohira

Marangou

et al. 2020

Annals of Medicine and Surgery

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Background Australia, although a high income economy, carries a significant burden of rheumatic heart disease (RHD). Acute rheumatic fever (ARF) and RHD are endemic in the Indigenous population. Immigrants from low/lower-income countries (‘non-Indigenous high-risk’) are also at increased risk compared with ‘non-Indigenous low-risk’ Australians. This study describes the utilisation of surgical and percutaneous procedures for RHD-related valve disease among patients aged less than 50 years, from 2002 to 2017. Methods A descriptive study using data from the ‘End RHD in Australia: Study of Epidemiology (ERASE) Project’ linking RHD Registers and hospital inpatient data from five states/territories, and two surgical databases. Trends across three-year periods were determined and post-procedural all-cause 30-day mortality calculated. Results A total of 3900 valves interventions were undertaken in 3028 procedural episodes among 2487 patients. Over 50% of patients were in the 35–49 years group, and 64% were female. Over 60% of procedures for 3-24 year-olds were for Indigenous patients. There were few significant changes across the study period other than downward trends in the number and proportion of procedures for young Indigenous patients (3–24 years) and ‘non-Indigenous/low risk’ patients aged ≥35 years. Mitral valve procedures predominated, and multi-valve interventions increased, including on the tricuspid valve. The majority of replacement prostheses were mechanical, although bioprosthetic valve use increased overall, being highest among females <35 years and Indigenous Australians. All-cause mortality (n = 42) at 30-days was 1.4% overall (range 1.1–1.7), but 2.0% for Indigenous patients. Conclusions The frequency of cardiac valve procedures, and 30-day mortality remained steady across 15 years. Some changes in the distribution of procedures in population groups were evident. Replacement procedures, the use of bioprosthetic valves, and multiple-valve interventions increased. The challenge for Australian public health officials is to reduce the incidence, and improve the early detection and management of ARF/RHD in high-risk populations within Australia.

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Changing trends in aortic valve procedures over the past ten years—from mechanical prosthesis via stented bioprosthesis to TAVI procedures—analysis of 50,846 aortic valve cases based on a Polish National Cardiac Surgery Database

Cited by 30 publications

References 31 publications

Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis

Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis

Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement – rationale and design of the international IMPACT registry

The use of cardiac valve procedures for rheumatic heart disease in Australia; a cross-sectional study 2002–2017

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