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EuroIntervention : Journal of EuroPCR... Aug 2023Data regarding the safety and long-term effectiveness of percutaneous closure of paravalvular leak (PVL) after transcatheter aortic valve implantation (TAVI) are scarce.
BACKGROUND
Data regarding the safety and long-term effectiveness of percutaneous closure of paravalvular leak (PVL) after transcatheter aortic valve implantation (TAVI) are scarce.
AIMS
This study aims to present a large multicentre international experience of percutaneous post-TAVI PVL closure.
METHODS
All patients who underwent percutaneous post-TAVI PVL closure in 14 hospitals across Europe and North America between January 2018 and October 2022 were included.
RESULTS
Overall, 45 patients (64% male) were enrolled. The median age was 80 years (75-84). Among them, 67% and 33% had self-expanding and balloon-expandable valve implantations, respectively. Baseline post-TAVI PVL was severe in 67% of cases and moderate in the rest. The time from index TAVI to PVL closure procedure was 16.1 (8.7-34.8) months. Most patients were in NYHA Class III and IV (73%) before the procedure, and 40% had referred hospitalisations for heart failure between TAVI and the PVL closure procedure. Successful PVL closure was achieved in 94%, reducing regurgitation to ≤mild in 91% and moderate in the rest. The Amplatzer Valvular Plug III was the most frequently used device (27 cases), followed by the Amplatzer Valvular Plug 4. The incidence of severe adverse events was 11%. None of the patients died during the index hospitalisation. During long-term follow-up (21.7±16.2 months), the all-cause mortality rate was 14%, and patients presented improvement in functional status and a significant reduction in the rate of hospitalisation for heart failure (from 40% to 6%).
CONCLUSIONS
Percutaneous PVL closure is a feasible and safe option for treating post-TAVI leaks. Successful PVL reduction to mild or less could be associated with acute and long-lasting improvements in clinical outcomes.
Topics: Humans; Male; Aged, 80 and over; Female; Transcatheter Aortic Valve Replacement; Heart Valve Prosthesis; Treatment Outcome; Heart Valve Prosthesis Implantation; Heart Failure; Registries; Aortic Valve; Aortic Valve Stenosis
PubMed: 37128805
DOI: 10.4244/EIJ-D-22-01110 -
Annals of Cardiothoracic Surgery May 2024In 1978, Rahimtoola published a successful series of surgical aortic valve replacements (SAVR) on patients with severe aortic stenosis (AS) with congestive heart failure... (Review)
Review
In 1978, Rahimtoola published a successful series of surgical aortic valve replacements (SAVR) on patients with severe aortic stenosis (AS) with congestive heart failure (CHF). He described the perfect prosthesis-patient match as a "prosthetic valve with a functioning opening area that matches the patient's normal functioning valve." This manuscript revisits the forty-six-year journey in pursuit of that perfect match. We address the essential components for the perfect match, such as the usefulness of the current valve sizing techniques using the manufacturer's labeled valve size (MLVS) and sizer, the accuracy of an objective parameter to define the perfect match, and the need and safety to enlarge the patient's annulus and root to accommodate the proper size valve. A thorough literature search was performed using the University of Michigan Medical Library search engine. The population included patients who underwent SAVR. Three individual searches were conducted: (I) valve size and sizing techniques; (II) hemodynamic performance (HP) and prosthesis-patient mismatch (PPM); and (III) aortic root enlargement (ARE) procedures. Excluded were articles not in English, articles that involved animal research, duplicate articles, articles involving valve repair, allograft or autograft replacement, and articles specific to aortic sizing and congenital heart surgery. The emphasis was placed on randomized prospective trials, large registry trials with and without propensity matching, and meta-analysis articles. We discovered that the manufacturer-labeled valve size and sizing technique does not accurately represent the functional opening area of the valve. A pre-operative multidetector computed tomography (CT) scan is an accurate and reproducible method for measuring patient root and annulus dimensions and should be used for pre-operative valve sizing for SAVR. Matching the CT area derived aortic diameter with the true functional diameter of the opening of the prosthetic valve will yield the best prosthesis-patient match. ARE is safe and should be used to attain the best match.
PubMed: 38841081
DOI: 10.21037/acs-2023-aae-0181 -
International Journal of Surgery... Nov 2023Improved durability of modern biologic prostheses and growing experience with the transcatheter valve-in-valve technique have contributed to a substantial increase in...
BACKGROUND
Improved durability of modern biologic prostheses and growing experience with the transcatheter valve-in-valve technique have contributed to a substantial increase in the use of bioprostheses in younger patients. However, discussion of prosthetic valve selection in dialysis patients remains scarce as the guidelines are updated. This study aims to compare long-term outcomes between propensity score-matched cohorts of dialysis patients who underwent primary aortic valve replacement with a mechanical prosthesis or a bioprosthesis.
MATERIALS AND METHODS
Longitudinal data of dialysis patients who underwent primary aortic valve replacement between 1 January 2001 and 31 December 2018, were retrieved from the National Health Insurance Research Database.
RESULTS
A total of 891 eligible patients were identified, of whom 243 ideally matched pairs of patients were analyzed. There was no significant difference in all-cause mortality (hazard ratio 1.11, 95% CI: 0.88-1.40) or the incidence of major adverse prosthesis-related events between the two groups (hazard ratio 1.03, 95% CI: 0.84-1.25). In patients younger than 50 years of age, using a mechanical prosthesis was associated with a significantly longer survival time across 10 years of follow-up than using a bioprosthesis (restricted mean survival time) at 10 years: 7.24 (95% CI: 6.33-8.14) years for mechanical prosthesis versus 5.25 (95% CI: 4.25-6.25) years for bioprosthesis, restricted mean survival time difference 1.99 years, 95% CI: -3.34 to -0.64).
CONCLUSION
A 2-year survival gain in favor of mechanical prostheses was identified in dialysis patients younger than 50 years. The authors suggest mechanical prostheses for aortic valve replacement in these younger patients.
Topics: Humans; Child; Aortic Valve; Heart Valve Prosthesis Implantation; Retrospective Studies; Treatment Outcome; Prosthesis Design; Renal Dialysis; Heart Valve Prosthesis; Bioprosthesis; Reoperation
PubMed: 37526125
DOI: 10.1097/JS9.0000000000000611 -
Infection Oct 2023Progress of interventional cardiology has boosted the use of newer cardiac devices. These devices are perceived to be less prone to infections compared to traditional... (Review)
Review
PURPOSE
Progress of interventional cardiology has boosted the use of newer cardiac devices. These devices are perceived to be less prone to infections compared to traditional surgical prostheses, but little data are currently available. In this systematic review (SR), we summarize current literature regarding the clinical characteristics, management, and outcomes of patients with MitraClip-related infective endocarditis (IE).
METHODS
We conducted a SR of PubMed, Google Scholar, Embase, and Scopus between January 2003 and March 2022. MitraClip-related IE was defined according to 2015 ESC criteria whereas MitraClip involvement as vegetation on the device or on the mitral valve. Risk of bias was assessed through standardized checklist and potential bias of underestimation cannot be excluded. Data regarding clinical presentation, echocardiography, management, and outcome were collected.
RESULTS
Twenty-six cases of MitraClip-related IE were retrieved. The median age of patients was 76 [61-83] years with a median EuroScore of 41%. Fever was present in 65.8% of patients followed by signs and symptoms of heart failure (42.3%). IE occurred early in 20 (76.9%) cases with a median time between MitraClip implantation and IE symptom onset of 5 [2-16] months. Staphylococcus aureus was the major causative microorganism (46%). Surgical mitral valve replacement was needed in 50% of patients. A conservative medical approach was considered in the remainder. The overall in-hospital mortality rate was 50% (surgical group: 38.4%; medical group: 58.3%; p = 0.433).
CONCLUSION
Our results suggest that MitraClip-related IE affects elderly, comorbid patients, is mostly due to Staphylococcus aureus, and has a poor prognosis irrespective of the therapeutic approach. Clinicians must be aware of the features of this new entity among cardiovascular infections.
Topics: Humans; Aged; Middle Aged; Aged, 80 and over; Heart Valve Prosthesis; Treatment Outcome; Endocarditis, Bacterial; Endocarditis; Mitral Valve; Mitral Valve Insufficiency
PubMed: 37386329
DOI: 10.1007/s15010-023-02067-y -
European Journal of Cardio-thoracic... Jan 2024This population-based cohort study investigated mid-term outcome after surgical aortic valve replacement with a bioprosthetic or mechanical valve prosthesis in patients...
OBJECTIVES
This population-based cohort study investigated mid-term outcome after surgical aortic valve replacement with a bioprosthetic or mechanical valve prosthesis in patients aged <50 years in a European social welfare state.
METHODS
We analysed patient data from the main social insurance carriers in Austria (2010-2020). Subsequent patient-level record linkage with national health data provided patient characteristics and clinical outcome. Survival, reoperation, myocardial infarction, heart failure, embolic stroke or intracerebral haemorrhage, bleeding other than intracerebral haemorrhage and major adverse cardiac events were evaluated as outcomes.
RESULTS
A total of 991 patients were analysed. Regarding demographics, no major differences between groups were observed. Multivariable Cox regression revealed no significant difference in overall survival (P = 0.352) with a median follow-up time of 6.2 years. Reoperation-free survival was decreased (hazard ratio = 1.560 [95% CI: 1.076-2.262], P = 0.019) and the risk for reoperation was increased (hazard ratio = 2.770 [95% CI: 1.402-5.472], P = 0.003) in patients who received bioprostheses. Estimated probability of death after reoperation was 0.23 (CL: 0.08-0.35) after 2 years and 0.34 (CL: 0.06-0.53) after 10 years over both groups. Regarding further outcomes, no significant differences between the two groups were observed.
CONCLUSIONS
In patients below 50 years of age receiving aortic valve replacement, implantation of bioprostheses when compared to mechanical heart valve prostheses was associated with a significantly higher rate of reoperations and reduced reoperation-free survival. Nevertheless, we could not observe a difference in overall survival. However, long-term follow-up has to evaluate that a significantly lower rate of reoperations may translate in consistently improved long-term survival.
Topics: Humans; Middle Aged; Heart Valve Prosthesis; Aortic Valve; Heart Valve Prosthesis Implantation; Cohort Studies; Prosthesis Design; Reoperation; Bioprosthesis; Cerebral Hemorrhage; Propensity Score; Treatment Outcome; Retrospective Studies; Prosthesis Failure
PubMed: 37756697
DOI: 10.1093/ejcts/ezad308 -
Multimedia Manual of Cardiothoracic... Nov 2023The Ross-Personalized External Aortic Root Support procedure is a surgical aortic valve replacement technique in which the autologous pulmonary valve is transposed in...
The Ross-Personalized External Aortic Root Support procedure is a surgical aortic valve replacement technique in which the autologous pulmonary valve is transposed in the aortic position to replace the malfunctioning aortic valve and a homograft is implanted in the pulmonary position. To prevent autograft dilatation, a Personalized External Aortic Root Support prosthesis is included in the proximal autograft anastomosis and wrapped around the ascending aorta. The aorta is transected transversely, the aortic valve is resected, and the coronary arteries are mobilized and cut out of the sinuses, leaving a rim. The pulmonary autograft is harvested by transecting the pulmonary artery and part of the right ventricular outflow tract. The autograft is approximated to the aortic root and inverted inside the ventricle. The proximal anastomosis is performed including the prosthesis between the aortic root and the autograft. The coronary buttons are threaded through appropriately positioned and sized holes in the prosthesis and reimplanted into the autograft. The ascending aorta is appropriately adapted and anastomosed with the distal autograft. When the patient is off cardiopulmonary bypass, the prosthesis can be closed longitudinally and is anchored to the distal aortic adventitia.
Topics: Humans; Autografts; Aorta, Thoracic; Transplantation, Autologous; Aortic Valve; Aorta; Aortic Valve Stenosis; Aortic Valve Insufficiency; Pulmonary Valve; Heart Valve Prosthesis Implantation; Reoperation
PubMed: 37942704
DOI: 10.1510/mmcts.2023.077 -
EuroIntervention : Journal of EuroPCR... Dec 2023The use of oversizing in mitral valve-in-valve (MViV) procedures can lead to non-uniform expansion of transcatheter heart valves (THV). This may have implications for...
BACKGROUND
The use of oversizing in mitral valve-in-valve (MViV) procedures can lead to non-uniform expansion of transcatheter heart valves (THV). This may have implications for THV durability.
AIMS
The objective of this study was to assess the extent and predictors of THV deformation in MViV procedures.
METHODS
We examined 33 patients who underwent MViV with SAPIEN prostheses. The extent of THV deformation (deformation index, eccentricity, neosinus volume, asymmetric leaflet expansion and vertical deformation) and hypoattenuating leaflet thickening (HALT) were assessed using cardiac computed tomography (CT), performed prospectively at 30 days post-procedure. For descriptive purposes, the THV deformation index was calculated, with values >1.00 representing a more hourglass shape.
RESULTS
Non-uniform underexpansion of THV was common after MViV implantation, with a median expansion area of 74.0% (interquartile range 68.1-84.1) at the narrowest level and a THV deformation index of 1.21 (1.13-1.29), but circularity was maintained with eccentricity ranging from 0.24 to 0.28. The degree of oversizing was a key factor associated with greater underexpansion and a higher deformation index (β=-0.634; p<0.001; β=0.594; p<0.001, respectively). Overall, the incidence of HALT on the 30-day postprocedural CT was 27.3% (9 of 33). Most patients (32 of 33) were on anticoagulation therapy, but the prothrombin time and international normalised ratio (PT-INR) at the time of the CT scan was <2.5 in 23 of 32 patients. Among patients with a PT-INR of <2.5, HALT was predominantly observed with a high THV deformation index of ≥1.18.
CONCLUSIONS
THV deformation, i.e., underexpansion and an hourglass shape, commonly occurs after MViV implantation and is negatively affected by excessive oversizing. Optimising THV expansion during MViV could potentially prevent HALT.
Topics: Humans; Aortic Valve Stenosis; Mitral Valve; Treatment Outcome; Heart Valve Prosthesis; Transcatheter Aortic Valve Replacement; Prosthesis Design; Aortic Valve
PubMed: 37899719
DOI: 10.4244/EIJ-D-23-00614 -
The Canadian Journal of Cardiology Feb 2024With the expansion of transcatheter aortic valve replacement (TAVR) to younger and lower-surgical-risk patients, many younger and less comorbid patients will be treated... (Review)
Review
With the expansion of transcatheter aortic valve replacement (TAVR) to younger and lower-surgical-risk patients, many younger and less comorbid patients will be treated with TAVR and are expected to have a life expectancy that will exceed the durability of their transcatheter heart valve. Consequently, the number of patients requiring reintervention will undoubtedly increase in the near future. Redo-TAVR and TAVR explantation followed by surgical aortic valve replacement are the different therapeutic options in the event of bioprosthetic valve failure and the need for reintervention. Patients often anticipate being able to benefit from a redo-TAVR in the event of bioprosthetic valve failure after TAVR, despite the lack of long-term data and the risk of unfavourable anatomy. Our understanding of the feasibility of redo-TAVR is constantly improving thanks to bench test studies and growing worldwide experience. However, much remains unknown. In clinical practice, one of the heart team's objectives is to anticipate the need to reaccess the coronary arteries and implant a second or even a third valve when life expectancy may exceed the durability of the transcatheter heart valve. In this review, we address key definitions in the diagnosis of structural valve deterioration and bioprosthetic valve failure, as well as patient selection and procedural planning for redo-TAVR to reduce periprocedural risk, optimise hemodynamic performance, and maintain coronary access. We describe the bench testing and literature in the redo-TAVR and TAVR explantation fields.
Topics: Humans; Transcatheter Aortic Valve Replacement; Treatment Outcome; Aortic Valve; Heart Valve Prosthesis Implantation; Heart Valve Prosthesis; Aortic Valve Stenosis; Risk Factors; Bioprosthesis; Prosthesis Design
PubMed: 38072363
DOI: 10.1016/j.cjca.2023.12.002 -
JACC. Cardiovascular Interventions Aug 2023The Harmony transcatheter pulmonary valve (TPV) is the first U.S. Food and Drug Administration-approved device for severe pulmonary regurgitation (PR) in the native or... (Clinical Trial)
Clinical Trial
BACKGROUND
The Harmony transcatheter pulmonary valve (TPV) is the first U.S. Food and Drug Administration-approved device for severe pulmonary regurgitation (PR) in the native or surgically repaired right ventricular outflow tract (RVOT).
OBJECTIVES
One-year safety and effectiveness of the Harmony TPV were evaluated in patients from the Harmony Native Outflow Tract Early Feasibility Study, Harmony TPV Pivotal Study, and Continued Access Study, representing the largest cohort to date of Harmony TPV recipients.
METHODS
Eligible patients had severe PR by echocardiography or PR fraction ≥ 30% by cardiac magnetic resonance imaging and clinical indications for pulmonary valve replacement. The primary analysis included 87 patients who received a commercially available TPV22 (n = 42) or TPV25 (n = 45) device; 19 patients who received an early device iteration prior to its discontinuation were evaluated separately.
RESULTS
In the primary analysis, median patient age at treatment was 26 years (IQR: 18-37 years) in the TPV22 group and 29 years (IQR: 19-42 years) in the TPV25 group. At 1 year, there were no deaths; 98% of TPV22 and 91% of TPV25 patients were free from the composite of PR, stenosis, and reintervention (moderate or worse PR, mean RVOT gradient >40 mmHg, device-related RVOT reoperation, and catheter reintervention). Nonsustained ventricular tachycardia occurred in 16% of patients. Most patients had none/trace or mild PR (98% of TPV22 patients, 97% of TPV25 patients). Outcomes with the discontinued device are reported separately.
CONCLUSIONS
The Harmony TPV device demonstrated favorable clinical and hemodynamic outcomes across studies and valve types through 1 year. Further follow-up will continue to assess long-term valve performance and durability.
Topics: Humans; Cardiac Catheterization; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Prospective Studies; Pulmonary Valve; Pulmonary Valve Insufficiency; Treatment Outcome; Ventricular Outflow Obstruction
PubMed: 37278682
DOI: 10.1016/j.jcin.2023.03.002 -
Polymers Nov 2023(1) Background: Polymeric heart valves are prostheses constructed out of flexible, synthetic materials to combine the advantageous hemodynamics of biological valves with...
(1) Background: Polymeric heart valves are prostheses constructed out of flexible, synthetic materials to combine the advantageous hemodynamics of biological valves with the longevity of mechanical valves. This idea from the early days of heart valve prosthetics has experienced a renaissance in recent years due to advances in polymer science. Here, we present progress on a novel, 3D-printable aortic valve prosthesis, the TIPI valve, removing the foldable metal leaflet restrictor structure in its center. Our aim is to create a competitive alternative to current valve prostheses made from flexible polymers. (2) Methods: Three-dimensional (3D) prototypes were designed and subsequently printed in silicone. Hemodynamic performance was measured with an HKP 2.0 hemodynamic testing device using an aortic valve bioprosthesis (BP), a mechanical prosthesis (MP), and the previously published prototype (TIPI 2.2) as benchmarks. (3) Results: The latest prototype (TIPI 3.4) showed improved performance in terms of regurgitation fraction (TIPI 3.4: 15.2 ± 3.7%, TIPI 2.2: 36.6 ± 5.0%, BP: 8.8 ± 0.3%, MP: 13.2 ± 0.7%), systolic pressure gradient (TIPI 3.4: 11.0 ± 2.7 mmHg, TIPI 2.2: 12.8 ± 2.2 mmHg, BP: 8.2 ± 0.9 mmHg, MP: 10.5 ± 0.6 mmHg), and effective orifice area (EOA, TIPI 3.4: 1.39 cm, TIPI 2.2: 1.28 cm, BP: 1.58 cm, MP: 1.38 cm), which was equivalent to currently used aortic valve prostheses. (4) Conclusions: Removal of the central restrictor structure alleviated previous concerns about its potential thrombogenicity and significantly increased the area of unobstructed opening. The prototypes showed unidirectional leaflet movement and very promising performance characteristics within our testing setup. The resulting simplicity of the shape compared to other approaches for polymeric heart valves could be suitable not only for 3D printing, but also for fast and easy mass production using molds and modern, highly biocompatible polymers.
PubMed: 38006137
DOI: 10.3390/polym15224413