Structural HeartPub Date : 2024-11-01DOI: 10.1016/j.shj.2024.100352
Jury Schewel MD, PhD , Ryan D. Madder MD , Dimitry Schewel MD, PhD
{"title":"Concept, Design, and Preclinical Testing of a Remote-Control Robotic System for Transesophageal Echocardiography","authors":"Jury Schewel MD, PhD , Ryan D. Madder MD , Dimitry Schewel MD, PhD","doi":"10.1016/j.shj.2024.100352","DOIUrl":"10.1016/j.shj.2024.100352","url":null,"abstract":"<div><h3>Background</h3><div>Interventional echocardiography (IE) plays a critical role in guiding structural heart interventions. IE specialists face challenges including high radiation exposure and unfavorable ergonomics. To address these issues, a novel remote-control robotic (RCR) system for transesophageal echocardiography (TEE) control has been developed. This study aims to describe the novel RCR system and to assess its performance in bench tests and in vitro models in terms of functionality, image quality, and reproducibility.</div></div><div><h3>Methods</h3><div>Bench testing and in vitro testing were performed using the RCR system. All tests were performed using the GE 6VT-D TEE probe and the GE Vivid E95.</div></div><div><h3>Results</h3><div>Key findings include proof of concept through bench testing, remote control of all five degrees of freedom of the TEE probe, and reliable, fast, and accurate reproducibility using automated navigation. The ROB’E Base is securely attached to the operating table, optimizing the footprint in the operating room. The ROB’E Guide accurately performs the forward and backward motion of the flexible portion of the TEE probe, stabilizing the achieved positions and preventing twisting during rotation. The ROB'E RCR system can store and reproduce TEE probe positions and has demonstrated reliable and accurate automated reproducibility in both bench and in vitro tests.</div></div><div><h3>Conclusions</h3><div>The ROB'E RCR system for TEE overcomes the limitations of conventional IE by using a RCR approach that eliminates the need for the echocardiographer to be physically present in the operating room. Thus, it significantly reduces radiation exposure and demonstrates its capabilities to improve image quality, reproducibility, and overall safety in IE.</div></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"8 6","pages":"Article 100352"},"PeriodicalIF":1.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142720869","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}
Structural HeartPub Date : 2024-11-01DOI: 10.1016/j.shj.2024.100326
Mark Zorman BM BCh, MA , Paul Bamford MB ChB, MA, MSc , Marco Coronelli MBBS, BSc , Cara Barnes MBBS, MPhil , Christopher Saunderson MB ChB, MD , James Gamble MA, MD , Sam Dawkins BSc, DPhil , Rajesh K. Kharbanda BSc, MB ChB, PhD , James Newton MB ChB, MD , Adrian P. Banning MBBS, MD , Daniel J. Blackman MB ChB, MD , Thomas J. Cahill MBBS, DPhil
{"title":"Prophylactic Permanent Pacemaker Implantation for Baseline Right Bundle Branch Block in Patients Undergoing Transcatheter Aortic Valve Replacement: Clinical Efficacy, Safety, and Long-Term Pacing Requirement","authors":"Mark Zorman BM BCh, MA , Paul Bamford MB ChB, MA, MSc , Marco Coronelli MBBS, BSc , Cara Barnes MBBS, MPhil , Christopher Saunderson MB ChB, MD , James Gamble MA, MD , Sam Dawkins BSc, DPhil , Rajesh K. Kharbanda BSc, MB ChB, PhD , James Newton MB ChB, MD , Adrian P. Banning MBBS, MD , Daniel J. Blackman MB ChB, MD , Thomas J. Cahill MBBS, DPhil","doi":"10.1016/j.shj.2024.100326","DOIUrl":"10.1016/j.shj.2024.100326","url":null,"abstract":"<div><h3>Background</h3><div>Baseline right bundle branch block (RBBB) is an established predictor of permanent pacemaker (PPM) requirement after transcatheter aortic valve replacement (TAVR). There are limited data to support prophylactic PPM implantation in advance of TAVR. We aimed to evaluate the efficacy and safety of prophylactic PPM implantation in patients with RBBB prior to TAVR, and to identify the predictors of pacing dependence after TAVR.</div></div><div><h3>Methods</h3><div>This was a retrospective cohort study of patients undergoing prophylactic PPM implantation for baseline RBBB prior to TAVR at two high-volume UK centers between 2014 and 2022.</div></div><div><h3>Results</h3><div>Baseline RBBB was identified in 170/4580 (3.7%) patients undergoing TAVR during the study period. Of these, 106/170 (62.4%) underwent prophylactic PPM implantation. This group had a significantly shorter median length of hospital stay after TAVR compared to patients with RBBB undergoing TAVR without prophylactic PPM implantation (2 vs. 4 days, <em>p</em> = 0.028). Urgent PPM implantation after TAVR was required in 43/64 (67.2%) of patients with RBBB who underwent TAVR without a prophylactic PPM. Analysis of ventricular pacing over 12 months post-TAVR demonstrated a significant pacing requirement (ventricular pacing > 10%) in 50/79 (63%) of patients with a prophylactic PPM. Pacing requirement was independently predicted by baseline first-degree heart block (odds ratio 2.4, <em>p</em> = 0.03) and QRS duration >140 ms (odds ratio 4.3, <em>p</em> = 0.01).</div></div><div><h3>Conclusions</h3><div>In this retrospective two-center cohort study, prophylactic PPM implantation for patients with baseline RBBB was safe, effective, and reduced the length of hospital stay. First-degree atrioventricular block and broad RBBB (QRS > 140 ms) were independent baseline predictors of significant pacing requirements.</div></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"8 6","pages":"Article 100326"},"PeriodicalIF":1.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142720873","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}
Structural HeartPub Date : 2024-11-01DOI: 10.1016/j.shj.2024.100321
Ankur Sethi MD , Sammy Elmariah MD, MPH , Candace Gunnarsson EdD, MA , Michael Ryan MS , Soumya Chikermane PhD , Christin Thompson PhD , Mark Russo MD
{"title":"The Cost of Waiting for a Transcatheter Aortic Valve Replacement in Medicare Beneficiaries With Severe Aortic Stenosis","authors":"Ankur Sethi MD , Sammy Elmariah MD, MPH , Candace Gunnarsson EdD, MA , Michael Ryan MS , Soumya Chikermane PhD , Christin Thompson PhD , Mark Russo MD","doi":"10.1016/j.shj.2024.100321","DOIUrl":"10.1016/j.shj.2024.100321","url":null,"abstract":"<div><h3>Background</h3><div>Aortic stenosis (AS) is a prevalent valvular disorder necessitating timely intervention, particularly when symptomatic. Aortic valve replacement (AVR) is the recommended treatment, but delays in access to AVR are common and linked to adverse outcomes and increased health care costs. This study aims to assess the health care cost burden associated with delaying transcatheter AVR (TAVR) in Medicare Advantage beneficiaries with clinically significant AS.</div></div><div><h3>Methods and Results</h3><div>This retrospective database study utilized the Optum de-identified U.S. claims database, encompassing Medicare Advantage enrollees. Patients aged 65 years or older were identified as having AS based on medical billing codes and were required to have a record of syncope, dyspnea, fatigue, chest pain/angina, or heart failure prior to, on or within 30 days of their incident AS diagnosis. Total health care costs were analyzed over a 2-year period, regressed against the delay in receiving TAVR, and adjusted for covariates. In the 4105 patients meeting study inclusion criteria, delays in TAVR were associated with a significant increase in health care costs, translating to those waiting 12 months for TAVR incurring an additional cost of $10,080 compared to those receiving TAVR promptly. Non-TAVR related costs largely drove this increase.</div></div><div><h3>Conclusions</h3><div>Delaying TAVR in clinically significant AS patients is associated with higher health care costs, emphasizing the need for timely interventions. Addressing delays in TAVR access and optimizing pre-TAVR workup can potentially improve patient outcomes and reduce health care expenditure.</div></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"8 6","pages":"Article 100321"},"PeriodicalIF":1.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141414566","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}
Structural HeartPub Date : 2024-11-01DOI: 10.1016/j.shj.2024.100335
Deborah Furman MD , Brian Whisenant MD
{"title":"Transcatheter Tricuspid Valve Clinical Trials: Incomplete Data and FDA-Approved Devices","authors":"Deborah Furman MD , Brian Whisenant MD","doi":"10.1016/j.shj.2024.100335","DOIUrl":"10.1016/j.shj.2024.100335","url":null,"abstract":"<div><div>Each reviewed trial of transcatheter tricuspid valve intervention demonstrated clinically meaningful improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ)-defined quality of life and favorable right ventricular remodeling. KCCQ correlates with tricuspid regurgitation (TR) reduction, heart failure hospitalization, and mortality. Change in KCCQ is therefore meaningful both as a measure of quality of life and as a surrogate endpoint of the impact of TV interventions. TRILUMINATE, the first randomized trial to evaluate the safety and efficacy of tricuspid edge-to-edge repair, demonstrated clinically important benefits in KCCQ score and favorable right ventricular remodeling, which are appropriate endpoints for this symptomatic population. TRISCEND II, which evaluated the safety and effectiveness of the EVOQUE valve, enrolled patients with more New York Heart Association class III and IV heart failure and lower KCCQ scores than TRILUMINATE. EVOQUE tricuspid valve replacement in TRISCEND II reduced TR to mild or less in 94% of patients compared to 50% of patients treated with TriClip in TRILUMINATE. The higher-risk TRISCEND II population and the near elimination of TR with EVOQUE are consistent with the favorable trend in EVOQUE mortality. Patients with diminished left ventricular systolic function being considered for either of these tricuspid valve interventions should be optimized with guideline directed medical therapy. Significant left-side valve disease should be treated. Patients should be optimally diuresed and excluded with severe pulmonary hypertension. Patients with persistent severe TR and symptoms or right ventricular enlargement should be considered for intervention. Smaller coaptation gaps without significant pacemaker impingement may be well served with transcatheter tricuspid edge-to-edge repair, while larger coaptation gaps and leaflets pinned by right ventricular leads, particularly in patients tolerating oral anticoagulation, may be best served with transcatheter tricuspid valve replacement.</div></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"8 6","pages":"Article 100335"},"PeriodicalIF":1.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141712811","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}
Structural HeartPub Date : 2024-09-01DOI: 10.1016/j.shj.2024.100359
Anthony DeMaria MD
{"title":"Implementation: The Final Step in Translating Innovation","authors":"Anthony DeMaria MD","doi":"10.1016/j.shj.2024.100359","DOIUrl":"10.1016/j.shj.2024.100359","url":null,"abstract":"","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"8 5","pages":"Article 100359"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2474870624001143/pdfft?md5=a018c807dbb53f2456317e0e15a0ebf6&pid=1-s2.0-S2474870624001143-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142095429","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}
Structural HeartPub Date : 2024-09-01DOI: 10.1016/j.shj.2024.100300
{"title":"Large Field-of-View Intravascular Ultrasound for Mitral and Tricuspid Valve-in-Valve Guidance: A Pilot Study","authors":"","doi":"10.1016/j.shj.2024.100300","DOIUrl":"10.1016/j.shj.2024.100300","url":null,"abstract":"<div><h3>Background</h3><p>Actual expansion of a transcatheter heart valve (THV) might differ from nominal, particularly during nonaortic valve-in-valve for a degenerated bioprosthetic surgical heart valve (SHV). This pilot study compared THV expansion measured using large-field-of-view intravascular ultrasound (IVUS) vs. multi-slice computed tomography (MSCT) and assessed the correlation between THV dimensions and transvalvular gradients.</p></div><div><h3>Methods</h3><p>Fourteen patients were successfully treated with mitral/tricuspid valve-in-valve SAPIEN 3 implantation sized using the true SHV inner diameter; all 14 had baseline MSCT and transvalvular gradients measured at baseline, postprocedure, and at discharge. Periprocedural IVUS (in 6 patients using a Philips 10MHz Vision PV035) was compared with postprocedural MSCT (in 9 patients) with offline measurements performed at 1-mm steps along the THV height. Overall, 190 MSCT and paired 124 IVUS cross-sections were analyzed.</p></div><div><h3>Results</h3><p>There was very good agreement between IVUS THV dimensions and corresponding MSCT measurements (intraclass correlation coefficient ≥0.986 and <em>p</em> < 0.001). IVUS measured THV expansion (percent of the nominal cross-sectional area) was smaller within the inflow and middle of the THV overlapping the ring (85.9% ± 11.3%, 83.8% ± 11.8%) than within the outflow (98.8% ± 12.7%). The residual mean transvalvular gradient increased from periprocedural to predischarge (3.5 ± 2.0 vs. 6.3 ± 1.7 mmHg, <em>p</em> < 0.001). The only independent predictor of predischarge maximal transvalvular gradient was the smallest minimal inner THV frame diameter (r<sup>2</sup> = 0.67), predicted by true SHV internal diameter (Beta = 0.066, 95% CI = 0.015-0.117, r<sup>2</sup> = 0.49, <em>p</em> = 0.037).</p></div><div><h3>Conclusions</h3><p>This pilot study is the first to report the feasibility of a large field-of-view IVUS for periprocedural measurement of actual THV expansion when deployed valve-in-valve. Minimal inner THV stent frame dimensions correlate with increased postprocedural transvalvular gradients.</p></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"8 5","pages":"Article 100300"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2474870624000319/pdfft?md5=f19201fa2c8a8ec670d8f04ce9304168&pid=1-s2.0-S2474870624000319-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140755769","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}
{"title":"Intracardiac Echocardiography-Guided Percutaneous Mitral Balloon Commissurotomy: Technique and Early Experience","authors":"Ahmed Hassanin MD, MPH, Modar Alom MD, Srinivasa Potluri MD, Karim Al-Azizi MD","doi":"10.1016/j.shj.2024.100330","DOIUrl":"10.1016/j.shj.2024.100330","url":null,"abstract":"<div><h3>Background</h3><p>Percutaneous mitral balloon commissurotomy (PMBC) is the gold standard for the treatment of patients with symptomatic rheumatic mitral valve (MV) stenosis and favorable valve morphology. Intracardiac ultrasound (ICE)-guided PMBC is an attractive alternative to standard transesophageal echocardiography guidance for simplification of procedure and avoiding general anesthesia.</p></div><div><h3>Methods</h3><p>We conducted a retrospective analysis of all ICE-guided PMBC cases at our institution between July 2020 and November 2023. Procedural success was defined as post-PMBC MV area ≥1.5 cm<sup>2</sup>; or an increase of ≥0.5 cm<sup>2</sup> in MV area associated with echocardiographic mitral regurgitation (MR) that is ≤moderate post-PMBC. Six-month follow-up data were collected.</p></div><div><h3>Results</h3><p>We identified 11 subjects for whom ICE-guided PMBC was attempted. The mean age of the subjects was 61.7 (±12.1) years. All, but one, were females. Out of the 11 subjects, 2 did not undergo PMBC; one had baseline severe MV regurgitation identified on ICE, and the other developed a pericardial effusion following transeptal puncture that needed an urgent pericardial window. The protocol-defined procedural success was achieved in all nine patients who underwent PMBC. Post-PMBC mean MV gradient was 4.4 (±2.0) as compared to 11.1 (±2.9) mmHg at baseline. At 6-month follow-up, 8 of the 9 patients had ≤New York Heart Association class II symptoms.</p></div><div><h3>Conclusions</h3><p>ICE-guided PMBC appears to be feasible and safe. ICE-guided PMBC offers several advantages over transesophageal echocardiography guidance including improving patient comfort and eliminating the need for patient intubation and general anesthesia.</p></div>","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"8 5","pages":"Article 100330"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2474870624000782/pdfft?md5=17bdbebf3ce8415d4d5e00ca09f4b762&pid=1-s2.0-S2474870624000782-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142095432","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}
Structural HeartPub Date : 2024-09-01DOI: 10.1016/j.shj.2024.100332
Anne-Sophie Lacharite-Roberge MD, Kurt S. Hoffmayer MD
{"title":"Electrophysiology Study During Transcatheter Aortic Valve Replacement to Predict High-Degree Atrioventricular Block: An Unfinished Tale","authors":"Anne-Sophie Lacharite-Roberge MD, Kurt S. Hoffmayer MD","doi":"10.1016/j.shj.2024.100332","DOIUrl":"10.1016/j.shj.2024.100332","url":null,"abstract":"","PeriodicalId":36053,"journal":{"name":"Structural Heart","volume":"8 5","pages":"Article 100332"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2474870624000800/pdfft?md5=78f7a7b61ab8a9a1dbf5741c21bfba94&pid=1-s2.0-S2474870624000800-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142095433","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}