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5.
Eur J Cardiothorac Surg ; 64(2)2023 08 01.
Article in English | MEDLINE | ID: mdl-37535847

ABSTRACT

PREAMBLE: The finalized document was endorsed by the EACTS Council and STS Executive Committee before being simultaneously published in the European Journal of Cardio-thoracic Surgery (EJCTS) and The Annals of Thoracic Surgery (The Annals) and the Journal of Thoracic and Cardiovascular Surgery (JTCVS).


Subject(s)
Thoracic Surgery , Humans , Coronary Artery Bypass , Heart , Prostheses and Implants , Societies, Medical
6.
Article in English | MEDLINE | ID: mdl-36858846

ABSTRACT

OBJECTIVE: To assess the mid-term clinical outcomes, hemodynamics, left ventricular (LV) mass regression, and structural valve deterioration (SVD) in patients implanted with the Perceval aortic sutureless valve across valve sizes. METHODS: Data were obtained from a multicenter European trial and a US Investigational Device Exemption trial. Echocardiography data were analyzed by an echocardiography core lab. A mixed-effects regression model was used to assess relationships between hemodynamic outcomes, time from the procedure, and valve sizes. The Valve Academic Research Consortium (VARC)-3 definition for bioprosthetic valve failure was applied. RESULTS: A Perceval sutureless valve was implanted in 970 patients. The median patient age was 77.8 years, 57.2% were female, the median Society of Thoracic Surgeons predicated risk of mortality was 3.3% (range, 2.1%-6.2%), and 33.4% had a concomitant procedure. The median clinical follow-up was 45.7 months (range, 28.2-76.1 months). Small and medium valves were implanted more commonly in women than in men (16.9% vs 1.9% for small and 55.1% vs 19.5% for medium; P < .001). The mean aortic valve gradients decreased significantly postimplantation and remained stable across all valve sizes throughout the follow-up period. All patients were free from severe patient-prosthesis mismatch (with an effective orifice area/m2 of >0.8). Significant LV mass regression was documented regardless valve sizes, plateaued at -9.1% at 5 years. Freedom from SVD and reintervention were 95.2% and 96.3%, respectively, at 5 years and were independent of implanted valve size (P = .22). The VARC-3 stage 3 bioprosthetic valve failure rate was low, 2.8% at 5 years. CONCLUSIONS: The Perceval valve demonstrated low and stable mean gradients, significant LV mass regression, and low SVD and reintervention rates across all valve sizes.

7.
JTCVS Tech ; 17: 23-46, 2023 Feb.
Article in English | MEDLINE | ID: mdl-36820352

ABSTRACT

Objective: The objective of this study was to compare short- and midterm clinical and echocardiographic outcomes according to the use of pledgeted sutures during aortic valve replacement. Methods: Patients with aortic stenosis or regurgitation requiring aortic valve replacement were enrolled in a prospective cohort study to evaluate the safety of a new stented bioprosthesis. Outcomes were analyzed according to the use of pledgets (pledgeted group) or no pledgets (nonpledgeted group). The primary outcome was a composite of thromboembolism, endocarditis, and major paravalvular leak at 5 years of follow-up. Secondary outcomes included multiple clinical endpoints and hemodynamic outcomes. Propensity score matching was performed to adjust for prognostic factors, and subanalyses with small valve sizes (<23 mm) and suturing techniques were performed. Results: The pledgeted group comprised 640 patients (59%), and the nonpledgeted group 442 (41%), with baseline discrepancies in demographic characteristics, comorbidities, and stenosis severity. There were no differences between groups in any outcome. After propensity score matching, the primary outcome occurred in 41 (11.7%) patients in the pledgeted and 36 (9.8%) in the nonpledgeted group (P = .51). The effective orifice area was smaller in the pledgeted group (P = .045), whereas no difference was observed for the mean or peak pressure gradient. Separate subanalyses with small valve sizes and suturing techniques did not show relevant differences. Conclusions: In this large propensity score-matched cohort, comprehensive clinical outcomes were comparable between patients who underwent aortic valve replacement with pledgeted and nonpledgeted sutures up to 5 years of follow-up, but pledgets might lead to a slightly smaller effective orifice area in the long run.

18.
Catheter Cardiovasc Interv ; 97(4): E580-E587, 2021 03.
Article in English | MEDLINE | ID: mdl-32894804

ABSTRACT

OBJECTIVES: We sought to document aortic cusps fluoroscopic projections and their distributions using leaflet alignment which is a novel concept to optimize visualization of leaflets and for guiding BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent coronary artery obstruction) and determine whether these projections were feasible in catheter laboratory. BACKGROUND: Optimal fluoroscopic projections of aortic valve cusps have not been well described. METHODS: A total of 128 pre-transcatheter aortic valve replacement (pre-TAVR) computed tomographies (CT) (72 native valves and 56 bioprosthetic surgical valves) were analyzed. Using CT software (3Mensio, Pie medical imaging, the Netherlands), leaflet alignment was performed and the feasibility of these angles, which were defined as rate of obtainable with efforts (within LAO/RAO of 85° and CRA/CAU of 50°) were evaluated. RESULTS: High feasibility was seen in right coronary cusp (RCC) front view (100%) and left coronary cusp (LCC) side view (99.2%), followed by noncoronary cusp side view (95.3%). In contrast, low feasibility of RCC side view (7.8%) and LCC front view (47.6%) was observed. No statistical differences were seen between the distribution of native valves and bioprosthetic surgical valves. With patient/table tilt of 20°LAO and 10°CRA, the feasibility of RCC side view and LCC front view increased to 43.7 and 85.2%, respectively. CONCLUSION: Distributions of each cusp's leaflet alignment follows "sigmoid curve" which can provide better understanding of aortic valve cusp orientation in TAVR and BASILICA. RCC side view used in right cusp BASILICA is commonly unachievable in catheter laboratory and may improve with patient/table tilt.


Subject(s)
Aortic Valve Stenosis , Bioprosthesis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Humans , Prosthesis Design , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
19.
J Cardiovasc Comput Tomogr ; 14(6): 516-519, 2020.
Article in English | MEDLINE | ID: mdl-32199758

ABSTRACT

BACKGROUND: Eccentricity of coronary ostial positions in relation to the aortic valve cusp may influence the target laceration location in BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Coronary Artery obstruction). Eccentricity of the coronary ostia in relation to coronary cusps of native and valve-in-valve transcatheter aortic valve replacement (TAVR) was not well described before. METHODS: A total of 121 pre-TAVR patients' CT data (72 native valves TAVR and 49 bioprosthetic surgical valves TAVR) was included and coronary ostial eccentricity angles were measured and compared. Coronary ostial angles were measured between mid-cusp line to coronary ostium in CT perpendicular images. RESULTS: In the overall cohort, the right coronary artery (RCA) had an eccentric origin in the majority of cases, favoring the commissure between the right and the non coronary cusp (17.0°, IQR; 10-25). On the other hand, the left coronary artery (LCA) originated most commonly near center of the cusp position (0°, IQR; -8 -7.5) In comparison of native and bioprosthetic valves, RCA ostial angles were more eccentric in native valves (19.0°, IQR; 12-26) than in bioprosthetic valves (14.0°, IQR; 3-20) (p = 0.004). Whereas, LCA ostial angle has no significant differences between native valves (-2.0°, IQR;-7.75-5.75) and bioprosthetic valves (1°, IQR;-8-13), (p = 0.6). CONCLUSION: RCA ostia often have an eccentric origin towards the non-coronary cusp, especially in native aortic valves, while LCA ostia commonly originate near the center of the cusp. This finding may contribute to better performance of BASILICA procedures.


Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Bioprosthesis , Computed Tomography Angiography , Coronary Angiography , Coronary Stenosis/prevention & control , Coronary Vessels/diagnostic imaging , Heart Valve Prosthesis , Multidetector Computed Tomography , Transcatheter Aortic Valve Replacement/instrumentation , Aged , Aortic Valve/diagnostic imaging , Aortic Valve Stenosis/diagnostic imaging , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/etiology , Female , Humans , Male , Predictive Value of Tests , Prosthesis Design , Risk Factors , Severity of Illness Index , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
20.
J Endovasc Ther ; 27(2): 252-257, 2020 04.
Article in English | MEDLINE | ID: mdl-32186260

ABSTRACT

Purpose: To evaluate the clinical and anatomical features of patients with arch pathology to better understand the applicability of the Zenith inner branched arch endograft (IBAE). Materials and Methods: A retrospective review was performed of 60 consecutive patients (mean age 62.5 years; 42 men) who presented with nonruptured aortic arch pathology at a single institution between 2009 and 2016. Patients were stratified into standard (no previous cardiac surgery, <80 years old, and no significant medical comorbidity), high (previous cardiac surgery or significant comorbidity), or prohibitive risk (turned down for operative intervention) for operative intervention. Anatomical measurements of the aorta were obtained on computed tomography scans; anatomical suitability was based on the device's instructions for use. Results: Overall, 27 (45%) patients had anatomy amenable to treatment with the existing IBAE. Inadequate proximal seal length and large ascending aortic diameters were the primary reasons for anatomical unsuitability. Shortening the inner curve seal zone from 25 to 15 mm and increasing the proximal seal zone diameter from 38 to 42 mm increased anatomical suitability to include 49 (82%) patients. Of these, 31 were in the high-risk cohort and 7 were deemed prohibitive risk; therefore, IBAE would have been strongly considered in these 38 patients. Conclusion: Based on anatomical criteria alone, nearly half of patients with aortic arch pathology have anatomy suitable to the Zenith IBAE in its current design. Arch branch vessel anatomy was not a limitation of the device. From a clinical standpoint, if endovascular repair were reserved for those at high or prohibitive risk for open repair, approximately 30% of patients would likely benefit from the IBAE in its current form.


Subject(s)
Aorta, Thoracic/surgery , Aortic Diseases/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Stents , Aged , Aged, 80 and over , Aorta, Thoracic/diagnostic imaging , Aorta, Thoracic/physiopathology , Aortic Diseases/diagnostic imaging , Aortic Diseases/physiopathology , Blood Vessel Prosthesis Implantation/adverse effects , Clinical Decision-Making , Endovascular Procedures/adverse effects , Female , Humans , Male , Middle Aged , Patient Selection , Prosthesis Design , Retrospective Studies , Risk Assessment , Risk Factors , Treatment Outcome
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