Pub Date : 2024-05-01DOI: 10.1016/j.shj.2024.100294
Philippe Généreux MD , Krzysztof Wróbel MD, PhD , Michael J. Rinaldi MD , Thomas Modine MD, PhD , Vinayak Bapat MD , Vlasis Ninios MD , Paul Sorajja MD
Background
Treatment options for patients with mitral regurgitation (MR) and mitral annular calcification (MAC) are limited. The limitations of current transcatheter mitral valve replacement (TMVR) technologies include high screen failure rates, increased risk of left ventricular outflow tract obstruction, and high residual regurgitation. The aim of this study was to evaluate outcomes of TMVR with the AltaValve system (4C Medical, Maple Grove, MN), a supra-annular TMVR with atrial fixation, in patients with severe MR and moderate or severe MAC.
Methods
Six patients with moderate or severe MAC who were treated with AltaValve TMVR had procedural and mid-term outcomes available.
Results
Technical success was achieved in all patients. Median follow-up was 232 days. At discharge, 80% of patients had none/trace MR, and 20% had mild MR. There was no intraprocedural mortality, device malposition, embolization, or thrombosis. One patient expired 3 days postprocedure due to complications related to the transapical access. All other patients were discharged from the hospital without issues. Echocardiography assessments at 30 days showed complete resolution of MR in all patients, with 1 patient with mild MR and a mean mitral valve gradient of 3.7 ± 1.4 mmHg. All patients were in New York Heart Association Class I/II at 30-day follow-up, showing marked improvement as compared with baseline.
Conclusions
In patients with severe MR and severe MAC, the AltaValve TMVR technology may represent a viable treatment option. The atrial fixation minimizes the risk of left ventricular outflow tract obstruction and potentially expands treatable patients, especially in patients with MAC.
{"title":"AltaValve Atrial Fixation System for the Treatment of Severe Mitral Regurgitation and Mitral Annular Calcification","authors":"Philippe Généreux MD , Krzysztof Wróbel MD, PhD , Michael J. Rinaldi MD , Thomas Modine MD, PhD , Vinayak Bapat MD , Vlasis Ninios MD , Paul Sorajja MD","doi":"10.1016/j.shj.2024.100294","DOIUrl":"10.1016/j.shj.2024.100294","url":null,"abstract":"<div><h3>Background</h3><p>Treatment options for patients with mitral regurgitation (MR) and mitral annular calcification (MAC) are limited. The limitations of current transcatheter mitral valve replacement (TMVR) technologies include high screen failure rates, increased risk of left ventricular outflow tract obstruction, and high residual regurgitation. The aim of this study was to evaluate outcomes of TMVR with the AltaValve system (4C Medical, Maple Grove, MN), a supra-annular TMVR with atrial fixation, in patients with severe MR and moderate or severe MAC.</p></div><div><h3>Methods</h3><p>Six patients with moderate or severe MAC who were treated with AltaValve TMVR had procedural and mid-term outcomes available.</p></div><div><h3>Results</h3><p>Technical success was achieved in all patients. Median follow-up was 232 days. At discharge, 80% of patients had none/trace MR, and 20% had mild MR. There was no intraprocedural mortality, device malposition, embolization, or thrombosis. One patient expired 3 days postprocedure due to complications related to the transapical access. All other patients were discharged from the hospital without issues. Echocardiography assessments at 30 days showed complete resolution of MR in all patients, with 1 patient with mild MR and a mean mitral valve gradient of 3.7 ± 1.4 mmHg. All patients were in New York Heart Association Class I/II at 30-day follow-up, showing marked improvement as compared with baseline.</p></div><div><h3>Conclusions</h3><p>In patients with severe MR and severe MAC, the AltaValve TMVR technology may represent a viable treatment option. The atrial fixation minimizes the risk of left ventricular outflow tract obstruction and potentially expands treatable patients, especially in patients with MAC.</p></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"8 3","pages":"Article 100294"},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2474870624000253/pdfft?md5=a83d817d1ffc1b4a3a7e2f92204ac847&pid=1-s2.0-S2474870624000253-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140279547","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-01DOI: 10.1016/j.shj.2023.100276
Go Hashimoto MD , Santiago Garcia MD , Hirotomo Sato MD, PhD , Miho Fukui MD, PhD , Muhammad Hammadah MD , Robert Steffen MD , Joao L. Cavalcante MD , Vinayak N. Bapat MD
Background
Bioprosthetic valve fracture (BVF) during valve-in-valve TAVR (transcatheter aortic valve replacement) is a procedural adjunct designed to optimize the expansion of the transcatheter heart valve and reduce patient-prosthesis mismatch by using a high-pressure balloon to intentionally fracture the surgical heart valve (SHV).
Methods
We performed bench testing on 15 bioprosthetic SHV to examine the optimal balloon size and pressure for BVF. We assessed morphological changes and expansion of SHV by computed tomography angiography. Successful BVF was defined as balloon waist disappearance on fluoroscopy and/or sudden pressure drop during balloon inflation.
Results
Nine valves met the definition of BVF, 3 of which were confirmed by disruption of the stent frame. We classified surgical valves into 3 subsets: 1) fracturable with metal stent frame (MSF), 2) fracturable with polymer stent frame (PSF) and 3) nonfracturable. In general, valves with MSF were fractured using a balloon size = true internal diameter plus 3-5 mm inflated at high pressure (16-20 ATM) whereas valves with PSF could be fractured with a balloon size = true internal diameter plus 3-5 mm and lower balloon pressure (6-14 ATM). Gains in computed tomography angiography derived inflow area after BVF were 12.3% for MSF and 3.6% for PSF SHV.
Conclusions
Gains in CT-determined valve area after BVF depend on the physical properties of the SHV, which in turn influences pressure thresholds and balloon sizing strategy for optimal BVF. Elastic recoil of PSF valves limits the gains in inflow area after BVF.
{"title":"New Insights and Perspective on Bioprosthetic Valve Fracture From Bench Testing and Computed Tomography Analysis","authors":"Go Hashimoto MD , Santiago Garcia MD , Hirotomo Sato MD, PhD , Miho Fukui MD, PhD , Muhammad Hammadah MD , Robert Steffen MD , Joao L. Cavalcante MD , Vinayak N. Bapat MD","doi":"10.1016/j.shj.2023.100276","DOIUrl":"10.1016/j.shj.2023.100276","url":null,"abstract":"<div><h3>Background</h3><p>Bioprosthetic valve fracture (BVF) during valve-in-valve TAVR (transcatheter aortic valve replacement) is a procedural adjunct designed to optimize the expansion of the transcatheter heart valve and reduce patient-prosthesis mismatch by using a high-pressure balloon to intentionally fracture the surgical heart valve (SHV).</p></div><div><h3>Methods</h3><p>We performed bench testing on 15 bioprosthetic SHV to examine the optimal balloon size and pressure for BVF. We assessed morphological changes and expansion of SHV by computed tomography angiography. Successful BVF was defined as balloon waist disappearance on fluoroscopy and/or sudden pressure drop during balloon inflation.</p></div><div><h3>Results</h3><p>Nine valves met the definition of BVF, 3 of which were confirmed by disruption of the stent frame. We classified surgical valves into 3 subsets: 1) fracturable with metal stent frame (MSF), 2) fracturable with polymer stent frame (PSF) and 3) nonfracturable. In general, valves with MSF were fractured using a balloon size = true internal diameter plus 3-5 mm inflated at high pressure (16-20 ATM) whereas valves with PSF could be fractured with a balloon size = true internal diameter plus 3-5 mm and lower balloon pressure (6-14 ATM). Gains in computed tomography angiography derived inflow area after BVF were 12.3% for MSF and 3.6% for PSF SHV.</p></div><div><h3>Conclusions</h3><p>Gains in CT-determined valve area after BVF depend on the physical properties of the SHV, which in turn influences pressure thresholds and balloon sizing strategy for optimal BVF. Elastic recoil of PSF valves limits the gains in inflow area after BVF.</p></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"8 3","pages":"Article 100276"},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2474870623002270/pdfft?md5=dc4b4504d617eb1cce9871314a0e5ed4&pid=1-s2.0-S2474870623002270-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139827128","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-01DOI: 10.1016/j.shj.2024.100281
Vilhelmas Bajoras MD , Ivan Wong MD , Xi Wang MD , Kamilė Čerlinskaitė-Bajorė MD , Gintautas Bieliauskas MD , Ole De Backer MD, PhD
{"title":"A Comparative Study of Transcatheter Aortic Valve Implantation Views for Two Different Self-Expanding Aortic Valves","authors":"Vilhelmas Bajoras MD , Ivan Wong MD , Xi Wang MD , Kamilė Čerlinskaitė-Bajorė MD , Gintautas Bieliauskas MD , Ole De Backer MD, PhD","doi":"10.1016/j.shj.2024.100281","DOIUrl":"10.1016/j.shj.2024.100281","url":null,"abstract":"","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"8 3","pages":"Article 100281"},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2474870624000022/pdfft?md5=16411e5d7dcdfc2ee893605fa4b529b4&pid=1-s2.0-S2474870624000022-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140466923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-01DOI: 10.1016/j.shj.2023.100228
Ajoe John Kattoor MD, Christopher Manion MD, Vijay Iyer MD, PhD
The SENTINEL Cerebral Protection System is one of the most commonly used devices for embolic protection during transcatheter aortic valve replacement. However, successful deployment of the SENTINEL device is often challenging in patients with a bovine aortic arch anatomy using the standard technique and requires extensive manipulation in the aortic arch increasing the risk of stroke. We describe a novel and simple technique of 2-filter deployment of SENTINEL device in patients with bovine arch anatomy. In this technique, after the deployment of the proximal filter, the device is hyperflexed on itself facing the lateral aspect of the ascending aorta instead of facing the descending aorta, with its tip pointing toward the common origin of the left common carotid artery (LCCA) and brachiocephalic trunk. The guidewire is then advanced to the LCCA. Since the guidewire can pass either anterior or posterior to the device shaft, the device needs to be untwisted either by clockwise or counterclockwise motion, before pulling the device shaft back to engage the LCCA, after which the distal filter can be deployed. Computed tomography scans obtained for planning transcatheter aortic valve replacement should be reviewed for the presence of bovine aortic arch anatomy so that this technique can be deployed directly, thereby reducing manipulations in the aortic arch, saving time, and not requiring additional equipment.
{"title":"A Simple Technique for Deploying the SENTINEL Cerebral Protection System in Bovine Aortic Arch Anatomy","authors":"Ajoe John Kattoor MD, Christopher Manion MD, Vijay Iyer MD, PhD","doi":"10.1016/j.shj.2023.100228","DOIUrl":"10.1016/j.shj.2023.100228","url":null,"abstract":"<div><p>The SENTINEL Cerebral Protection System is one of the most commonly used devices for embolic protection during transcatheter aortic valve replacement. However, successful deployment of the SENTINEL device is often challenging in patients with a bovine aortic arch anatomy using the standard technique and requires extensive manipulation in the aortic arch increasing the risk of stroke. We describe a novel and simple technique of 2-filter deployment of SENTINEL device in patients with bovine arch anatomy. In this technique, after the deployment of the proximal filter, the device is hyperflexed on itself facing the lateral aspect of the ascending aorta instead of facing the descending aorta, with its tip pointing toward the common origin of the left common carotid artery (LCCA) and brachiocephalic trunk. The guidewire is then advanced to the LCCA. Since the guidewire can pass either anterior or posterior to the device shaft, the device needs to be untwisted either by clockwise or counterclockwise motion, before pulling the device shaft back to engage the LCCA, after which the distal filter can be deployed. Computed tomography scans obtained for planning transcatheter aortic valve replacement should be reviewed for the presence of bovine aortic arch anatomy so that this technique can be deployed directly, thereby reducing manipulations in the aortic arch, saving time, and not requiring additional equipment.</p></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"8 2","pages":"Article 100228"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2474870623001227/pdfft?md5=7759bd00e6827626f09d5c2d4a17dfd0&pid=1-s2.0-S2474870623001227-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135809361","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-01DOI: 10.1016/j.shj.2023.100274
Anita W. Asgar MD, MSc, Theofilos Panagiotidis MD
{"title":"Editorial: Real World Transcatheter Edge to Edge Repair Eligibility in HF Patients: Finding the Opportunity","authors":"Anita W. Asgar MD, MSc, Theofilos Panagiotidis MD","doi":"10.1016/j.shj.2023.100274","DOIUrl":"10.1016/j.shj.2023.100274","url":null,"abstract":"","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"8 2","pages":"Article 100274"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2474870623002245/pdfft?md5=050dd7bf34c29ef5ecd55d57232718e4&pid=1-s2.0-S2474870623002245-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139538116","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-01DOI: 10.1016/j.shj.2023.100231
Henrik Bjursten MD, PhD , Sasha Koul MD, PhD , Pétur Pétursson MD, PhD , Jacob Odenstedt MD, PhD , Henrik Hagström MD , Jenny Backes MD , Niels Erik Nielsen MD, PhD , Andreas Rück MD, PhD , Jan Johansson MD , Stefan James MD, PhD , Magnus Settergren MD, PhD , Matthias Götberg MD, PhD , Troels Yndigen MD
Background
Transcatheter aortic valve implantation (TAVI) has become a safe procedure. However, complications occur, including uncommon complications such as valve malposition, which requires the implantation of an additional rescue valve (rescue-AV). The aim was to study the occurrence and outcomes of rescue-AV in a nationwide registry.
Methods
The Swedish national TAVI registry was used as the primary data source, where all 6706 TAVI procedures from 2016 to 2021 were retrieved. Nontransfemoral access and planned valve-in-valve were excluded. In total, 79 patients were identified as having had a rescue-AV, and additional detailed data were collected for these patients. This dataset was analyzed for any characteristics that could predispose patients to a rescue-AV. The outcome of patients receiving rescue-AV also was studied.
Results
Of the 5948 patients in the study, 1.3% had a rescue-AV. There were few differences between patients receiving 1 valve and rescue-AV patients. For patients receiving a rescue-AV, the 30-day mortality was 15.2% compared to 1.6% in the control group. A poor outcome after rescue-AV was often associated with a second complication; for example, stroke, need for emergency surgery, or heart failure. Among the patients with rescue-AV who survived at least 30 days, landmark analyses showed similar survival rates compared to the control group.
Conclusions
Among TAVI patients in a nationwide register, rescue-AV occurred in 1.3% of patients. The 30-day mortality in patients receiving rescue-AV was high, but long-term outcome among 30-day survivors was similar to the control group.
{"title":"Characteristics and Outcomes of Patients Receiving a Second Rescue Valve During Transcatheter Aortic Valve Implantation","authors":"Henrik Bjursten MD, PhD , Sasha Koul MD, PhD , Pétur Pétursson MD, PhD , Jacob Odenstedt MD, PhD , Henrik Hagström MD , Jenny Backes MD , Niels Erik Nielsen MD, PhD , Andreas Rück MD, PhD , Jan Johansson MD , Stefan James MD, PhD , Magnus Settergren MD, PhD , Matthias Götberg MD, PhD , Troels Yndigen MD","doi":"10.1016/j.shj.2023.100231","DOIUrl":"10.1016/j.shj.2023.100231","url":null,"abstract":"<div><h3>Background</h3><p>Transcatheter aortic valve implantation (TAVI) has become a safe procedure. However, complications occur, including uncommon complications such as valve malposition, which requires the implantation of an additional rescue valve (rescue-AV). The aim was to study the occurrence and outcomes of rescue-AV in a nationwide registry.</p></div><div><h3>Methods</h3><p>The Swedish national TAVI registry was used as the primary data source, where all 6706 TAVI procedures from 2016 to 2021 were retrieved. Nontransfemoral access and planned valve-in-valve were excluded. In total, 79 patients were identified as having had a rescue-AV, and additional detailed data were collected for these patients. This dataset was analyzed for any characteristics that could predispose patients to a rescue-AV. The outcome of patients receiving rescue-AV also was studied.</p></div><div><h3>Results</h3><p>Of the 5948 patients in the study, 1.3% had a rescue-AV. There were few differences between patients receiving 1 valve and rescue-AV patients. For patients receiving a rescue-AV, the 30-day mortality was 15.2% compared to 1.6% in the control group. A poor outcome after rescue-AV was often associated with a second complication; for example, stroke, need for emergency surgery, or heart failure. Among the patients with rescue-AV who survived at least 30 days, landmark analyses showed similar survival rates compared to the control group.</p></div><div><h3>Conclusions</h3><p>Among TAVI patients in a nationwide register, rescue-AV occurred in 1.3% of patients. The 30-day mortality in patients receiving rescue-AV was high, but long-term outcome among 30-day survivors was similar to the control group.</p></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"8 2","pages":"Article 100231"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2474870623001252/pdfft?md5=d8e7317bcc2e227b6226a3cbf035db7d&pid=1-s2.0-S2474870623001252-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135765403","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-01DOI: 10.1016/j.shj.2023.100237
Andrew P. Ambrosy MD , Jingrong Yang MA , Andrew S. Tai MD , Sadia J. Dimbil MD , Elisha A. Garcia BS , Sue Hee Sung MPH , Ankeet S. Bhatt MD, MBA , Matthew D. Solomon MD, PhD , Ivy A. Ku MD, MAS , Jacob M. Mishell MD , Edward J. McNulty MD , Jonathan G. Zaroff MD , Andrew N. Rassi MD , Jeremy Kong MD , Alan S. Go MD
Background
The eligibility and potential benefit of transcatheter edge-to-edge repair (TEER) in addition to guideline-directed medical therapy to treat moderate-severe or severe secondary mitral regurgitation (MR) has not been reported in a contemporary heart failure (HF) population.
Methods
Eligibility for TEER based on Food and Drug Administration (FDA) labeling: (1) HF symptoms, (2) moderate-severe or severe MR, (3) left ventricular ejection fraction (LVEF) 20% to 50%, (4) left ventricular end-systolic dimension 7.0 cm, and (5) receiving GDMT (blocker + angiotensin-converting enzyme inhibitor/angiotensin receptor blocker). The proportion (%) of patients eligible for TEER. The hypothetical number needed to treat to prevent or postpone adverse outcomes was estimated using relative risk reductions from published hazard ratios in the registration trial and the observed event rates.
Results
We identified 50,841 adults with HF and known LVEF. After applying FDA criteria, 2461 patients (4.8%) were considered eligible for transcatheter mitral valve replacement (FDA+), with the vast majority of patients excluded (FDA-) based on a lack of clinically significant MR (N = 47,279). FDA+ patients had higher natriuretic peptide levels and were more likely to have a prior HF hospitalization compared to FDA- patients. Although FDA+ patients had a more dilated left ventricle and lower LVEF, median (25th-75th) left ventricular end-systolic dimension (cm) was low at 4.4 (3.7-5.1) and only 30.8% had severely reduced LVEF. FDA+ patients were at higher risk of HF-related morbidity and mortality. The estimated number needed to treat to potentially prevent or postpone all-cause hospitalization was 4.4, 8.8 for HF hospitalization, and 5.3 for all-cause death at 24 months in FDA+ patients.
Conclusions
There is a low prevalence of TEER eligibility based on FDA criteria primarily due to absence of moderate-severe or severe MR. FDA+ patients are a high acuity population and may potentially derive a robust clinical benefit from TEER based on pivotal studies. Additional research is necessary to validate the scope of eligibility and comparative effectiveness of TEER in real-world populations.
{"title":"Eligibility and Potential Benefit of Transcatheter Edge-to-Edge Repair in a Contemporary Cohort With Heart Failure: Evidence From a Large Integrated Health Care Delivery System","authors":"Andrew P. Ambrosy MD , Jingrong Yang MA , Andrew S. Tai MD , Sadia J. Dimbil MD , Elisha A. Garcia BS , Sue Hee Sung MPH , Ankeet S. Bhatt MD, MBA , Matthew D. Solomon MD, PhD , Ivy A. Ku MD, MAS , Jacob M. Mishell MD , Edward J. McNulty MD , Jonathan G. Zaroff MD , Andrew N. Rassi MD , Jeremy Kong MD , Alan S. Go MD","doi":"10.1016/j.shj.2023.100237","DOIUrl":"10.1016/j.shj.2023.100237","url":null,"abstract":"<div><h3>Background</h3><p>The eligibility and potential benefit of transcatheter edge-to-edge repair (TEER) in addition to guideline-directed medical therapy to treat moderate-severe or severe secondary mitral regurgitation (MR) has not been reported in a contemporary heart failure (HF) population.</p></div><div><h3>Methods</h3><p>Eligibility for TEER based on Food and Drug Administration (FDA) labeling: (1) HF symptoms, (2) moderate-severe or severe MR, (3) left ventricular ejection fraction (LVEF) 20% to 50%, (4) left ventricular end-systolic dimension 7.0 cm, and (5) receiving GDMT (blocker + angiotensin-converting enzyme inhibitor/angiotensin receptor blocker). The proportion (%) of patients eligible for TEER. The hypothetical number needed to treat to prevent or postpone adverse outcomes was estimated using relative risk reductions from published hazard ratios in the registration trial and the observed event rates.</p></div><div><h3>Results</h3><p>We identified 50,841 adults with HF and known LVEF. After applying FDA criteria, 2461 patients (4.8%) were considered eligible for transcatheter mitral valve replacement (FDA+), with the vast majority of patients excluded (FDA-) based on a lack of clinically significant MR (N = 47,279). FDA+ patients had higher natriuretic peptide levels and were more likely to have a prior HF hospitalization compared to FDA- patients. Although FDA+ patients had a more dilated left ventricle and lower LVEF, median (25th-75th) left ventricular end-systolic dimension (cm) was low at 4.4 (3.7-5.1) and only 30.8% had severely reduced LVEF. FDA+ patients were at higher risk of HF-related morbidity and mortality. The estimated number needed to treat to potentially prevent or postpone all-cause hospitalization was 4.4, 8.8 for HF hospitalization, and 5.3 for all-cause death at 24 months in FDA+ patients.</p></div><div><h3>Conclusions</h3><p>There is a low prevalence of TEER eligibility based on FDA criteria primarily due to absence of moderate-severe or severe MR. FDA+ patients are a high acuity population and may potentially derive a robust clinical benefit from TEER based on pivotal studies. Additional research is necessary to validate the scope of eligibility and comparative effectiveness of TEER in real-world populations.</p></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"8 2","pages":"Article 100237"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2474870623001318/pdfft?md5=dcd42176220bdea1430d127bbd5ce43f&pid=1-s2.0-S2474870623001318-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139022856","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
It is unknown whether bioprostheses used for transcatheter aortic valve implantation will have similar long-term durability as those used for surgical aortic valve replacement. Repetitive mechanical stress applied to the valve leaflets, particularly during diastole, is the main determinant of structural valve deterioration. Leaflet mechanical stress cannot be measured in vivo. The objective of this in vitro/in silico study was thus to compare the magnitude and regional distribution of leaflet mechanical stress in old vs new generations of self-expanding (SE) vs balloon expandable (BE) transcatheter heart valves (THVs).
Methods
A double activation simulator was used for in vitro testing of two generations of SE THV (Medtronic CoreValve 26 mm and EVOLUT PRO 26 mm) and two generations of BE THV (Edwards SAPIEN 23 mm vs SAPIEN-3 23 mm). These THVs were implanted within a 21-mm aortic annulus. A noncontact system based on stereophotogammetry and digital image correlation with high spatial and temporal resolution (2000 img/sec) was used to visualize the valve leaflet motion and perform the three-dimensional analysis. A finite element model of the valve was developed, and the leaflet deformation obtained from the digital image correlation analysis was applied to the finite element model to calculate local leaflet mechanical stress during diastole.
Results
The maximum von Mises leaflet stress was higher in early vs new THV generation (p < 0.05) and in BE vs SE THV (p < 0.05): early generation BE: 2.48 vs SE: 1.40 MPa; new generation BE: 1.68 vs SE: 1.07 MPa. For both types of THV, the highest values of leaflet stress were primarily observed in the upper leaflet edge near the commissures and to a lesser extent in the mid-portion of the leaflet body, which is the area where structural leaflet deterioration most often occurs in vivo.
Conclusions
The results of this in vitro/in silico study suggest that: i) Newer generations of THVs have ∼30% lower leaflet mechanical stress than the early generations; ii) For a given generation, SE THVs have lower leaflet mechanical stress than BE THVs. Further studies are needed to determine if these differences between new vs early THV generations and between SE vs BE THVs will translate into significant differences in long-term valve durability in vivo.
背景经导管主动脉瓣植入术中使用的生物假体是否具有与外科主动脉瓣置换术中使用的生物假体相似的长期耐久性,目前还不得而知。瓣叶受到的重复机械应力,尤其是在舒张期,是瓣膜结构退化的主要决定因素。瓣叶机械应力无法在体内测量。因此,这项体外/硅学研究的目的是比较新旧两代自扩张(SE)和球囊扩张(BE)经导管心脏瓣膜(THV)瓣叶机械应力的大小和区域分布。方法使用双活化模拟器对两代 SE THV(美敦力 CoreValve 26 毫米和 EVOLUT PRO 26 毫米)和两代 BE THV(Edwards SAPIEN 23 毫米和 SAPIEN-3 23 毫米)进行体外测试。这些 THV 均植入 21 毫米的主动脉瓣环内。使用基于立体摄影测量和数字图像关联的非接触系统,以高空间和时间分辨率(2000 IMG/秒)观察瓣叶运动并进行三维分析。结果 早期 THV 与新一代 THV 相比(p < 0.05),BE THV 与 SE THV 相比(p < 0.05),Von Mises 瓣叶最大应力更高:早期 BE:2.48 MPa,SE:1.40 MPa;新一代 BE:1.68 MPa,SE:1.07 MPa。对于这两种类型的 THV,小叶应力的最高值主要出现在靠近合叶的小叶上缘,其次是小叶体的中间部分,而这正是体内小叶结构退化最常发生的区域。结论这项体外/硅学研究结果表明:i) 新一代 THV 的小叶机械应力比早期 THV 低 30%;ii) 在给定的一代中,SE THV 的小叶机械应力比 BE THV 低。需要进一步研究来确定新一代 THV 与早期 THV 之间以及 SE THV 与 BE THV 之间的这些差异是否会转化为体内瓣膜长期耐久性的显著差异。
{"title":"Leaflet Mechanical Stress in Different Designs and Generations of Transcatheter Aortic Valves: An in Vitro Study","authors":"Viktória Stanová Dipl-Ing, MSc, PhD , Régis Rieu Dipl-Ing, PhD , Lionel Thollon PhD , Erwan Salaun MD, PhD , Josep Rodés-Cabau MD , Nancy Côté PhD , Diego Mantovani Dipl-Ing, PhD , Philippe Pibarot DVM, PhD","doi":"10.1016/j.shj.2023.100262","DOIUrl":"10.1016/j.shj.2023.100262","url":null,"abstract":"<div><h3>Background</h3><p>It is unknown whether bioprostheses used for transcatheter aortic valve implantation will have similar long-term durability as those used for surgical aortic valve replacement. Repetitive mechanical stress applied to the valve leaflets, particularly during diastole, is the main determinant of structural valve deterioration. Leaflet mechanical stress cannot be measured in vivo. The objective of this in vitro/in silico study was thus to compare the magnitude and regional distribution of leaflet mechanical stress in old vs new generations of self-expanding (SE) vs balloon expandable (BE) transcatheter heart valves (THVs).</p></div><div><h3>Methods</h3><p>A double activation simulator was used for in vitro testing of two generations of SE THV (Medtronic CoreValve 26 mm and EVOLUT PRO 26 mm) and two generations of BE THV (Edwards SAPIEN 23 mm vs SAPIEN-3 23 mm). These THVs were implanted within a 21-mm aortic annulus. A noncontact system based on stereophotogammetry and digital image correlation with high spatial and temporal resolution (2000 img/sec) was used to visualize the valve leaflet motion and perform the three-dimensional analysis. A finite element model of the valve was developed, and the leaflet deformation obtained from the digital image correlation analysis was applied to the finite element model to calculate local leaflet mechanical stress during diastole.</p></div><div><h3>Results</h3><p>The maximum von Mises leaflet stress was higher in early vs new THV generation (<em>p</em> < 0.05) and in BE vs SE THV (<em>p</em> < 0.05): early generation BE: 2.48 vs SE: 1.40 MPa; new generation BE: 1.68 vs SE: 1.07 MPa. For both types of THV, the highest values of leaflet stress were primarily observed in the upper leaflet edge near the commissures and to a lesser extent in the mid-portion of the leaflet body, which is the area where structural leaflet deterioration most often occurs in vivo.</p></div><div><h3>Conclusions</h3><p>The results of this in vitro/in silico study suggest that: i) Newer generations of THVs have ∼30% lower leaflet mechanical stress than the early generations; ii) For a given generation, SE THVs have lower leaflet mechanical stress than BE THVs. Further studies are needed to determine if these differences between new vs early THV generations and between SE vs BE THVs will translate into significant differences in long-term valve durability in vivo.</p></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"8 2","pages":"Article 100262"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2474870623001987/pdfft?md5=87b82c12387f302694e45cd357df1f66&pid=1-s2.0-S2474870623001987-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138993879","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}