Abstract Background/Introduction Transcatheter mitral valve replacement (TMVR) is emerging as a therapeutic option for surgcal high-risk patients with mitral regurgitation (MR). However, a large proportion of these patients are still rejected due to clinical or anatomical reasons. The majority of these patients remain ineligible for any mitral valve (MV) intervention and continue medical treatment. Phenotypic characterization of these patients may assist in the identification of the anatomical challenges and drive future innovation efforts as well as assist in the risk stratification process of these patients. Purpose To characterize patients ineligible for TMVR and other MV interventions from a large international registry using an unsupervised phenotypic clustering approach integrating clinical, echocardiographic and computed tomography data to unveil differences between phenogroups. Methods Between 2014 and 2022, the CHOICE-MI registry included 984 patients undergoing screening for TMVR at 33 international sites. For this study, only patients with screening failure resulting in medical therapy alone were included. Patients receiving transcatheter or surgical treatment were excluded (Figure 1). A cluster analysis using K-means algorithm was performed on baseline clinical and imaging variables, and predictors of all-cause mortality within these clusters were assessed. Results Among 284 patients (77.4±8.82 years, 56.0% female, EuroSCORE II 6.6±5.8%) considered ineligible for any MV intervention, two clinically distinct phenogroups (PG) were identified using unsupervised hierarchical clustering of principal components (Figure 2): (PG1) Elderly women with primary MR, high left ventricular (LV) ejection fraction, and annular calcification (N=173, 60.9%); (PG2) Patients with secondary or mixed MR, LV and annular dilation, and high prevalence of comorbidities (N=111, 39.1%). There were no differences regarding Kaplan-Meier estimated 1-year all-cause mortality (PG1 vs. PG2, 21.4% vs. 23.4%, p=0.89) and 1-year cardiovascular mortality (10.4% vs. 13.5%, p=0.53). Predictors of mortality were albumin, renal function, extracardiac arteriopathy for PG1, and albumin, coronary artery disease, and prior myocardial infarction for PG2. Conclusions Using cluster analysis, this study identified two major subgroups among patients ineligible for mitral interventions with profound differences in clinical and anatomical profiles, and predictors of outcome. The combination of elderly women with primary MR, preserved LV ejection fraction and annular calcification was the most common phenogroup among patients rejected for mitral intervention. Identifying these factors may drive technological evolution to address unmet clinical and technical needs.
Background: Transcatheter mitral valve replacement (TMVR) using dedicated devices is an alternative therapy for high-risk patients with mitral regurgitation (MR). This study aimed to assess 2-year outcomes and predictors of mortality in patients undergoing TMVR from the CHOICE-MI multicenter registry.
Background No data currently exist comparing the contemporary iterations of balloon-expandable (BE) Edwards SAPIEN 3/Ultra and the self-expanding (SE) Medtronic Evolut PRO/R34 valves. The aim of the study was the comparison of these transcatheter heart valves with emphasis on patients with small aortic annulus. Methods and Results In this retrospective registry, periprocedural outcomes and midterm all-cause mortality were analyzed. A total of 1673 patients (917 SE versus 756 BE) were followed up for a median of 15 months. A total of 194 patients died (11.6%) during follow-up. SE and BE groups showed similar survival at 1 (92.6% versus 90.6%) and 3 (80.3% versus 85.2%) years (Plog-rank=0.136). Compared with the BE group, patients treated with the SE device had lower peak (16.3 +/- 8 mm Hg SE versus 21.9 +/- 8 mm Hg BE) and mean (8.8 +/- 5 mm Hg SE versus 11.5 +/- 5 mm Hg BE) gradients at discharge. Conversely, the BE group demonstrated lower rates of at least moderate paravalvular regurgitation postoperatively (5.6% versus 0.7% for SE and BE valves, respectively; P<0.001). In patients treated with small transcatheter heart valves (<= 26 mm for SE and <= 23 mm for BE; N=284 for SE and N=260 for BE), survival was higher among patients treated with SE valves at both 1 (96.7% SE versus 92.1% BE) and 3 (91.8% SE versus 82.2% BE) years (Plog-rank=0.042). In propensity-matched patients treated with small transcatheter heart valve, there remained a trend for higher survival among the SE group at both 1 (97% SE versus 92.3% BE) and 3 years (91.8% SE versus 78.7% BE), Plog-rank=0.096). Conclusions Real-world comparison of the latest-generation SE and BE devices demonstrated similar survival up to 3 years' follow-up. In patients with small transcatheter heart valves, there may be a trend for improved survival among those treated with SE valves.
Background: Transcatheter mitral valve implantation (TMVI) is a novel treatment alternative for patients with mitral regurgitation (MR), who are suboptimal candidates for mitral valve surgery or transcatheter edge-to-edge repair. However, extensive data on outcomes of patients treated with TMVI is scarce.
Abstract Background/Introduction The balloon expandable (BE) Edwards Sapien-S3/Ultra, and the self-expanding (SE) Medtronic Evolut-Pro represent the main volume of transcatheter aortic valve implantation (TAVI) procedures conducted worldwide. Purpose The present study represents the largest real-world comparison of periprocedural and short-term outcome between the aforementioned last generation devices. Methods Consecutive patients who had undergone TAVI with either the BE (S3/Ultra) or SE (Evolut-Pro/R-34mm if 34mm valve was required) device, in five centers were retrospectively studied. Periprocedural and short-term outcomes were recorded and compared. Results In total, 1341 patients (58.5% male) were treated with contemporary BE and SE valves (574 and 767pts with BE and SE respectively) and followed up for a median of 18.7 (IQR 30) months. Baseline demographics were similar between the two groups apart from severe left ventricle (LV) systolic impairment and extensive aorta calcification, being more prevalent amongst BE and SE groups respectively. Patients treated with the Evolut-Pro/R34mm device had significantly lower peak (16±9mmHg for SE vs 23.9±6mmHg for the BE valves, p=0.001) and mean (8.6±6mmHg SE vs 11.2±5.2mmHg BE, p=0.001) gradients at discharge. Conversely, the BE group demonstrated significantly lower rates of at least moderate residual aortic regurgitation (AR) post-operatively (0.7% vs 5.2% for BE and SE valves respectively, p<0.001). Interestingly, the rate of new permanent pacemaker (PPM) required after the implantation in initially pacemaker-free patients, was higher for the S3/Ultra cohort compared to the self-expanding valve group (14.4% vs 12.3% respectively, p=0.001). No statistical difference was recorded between valve groups regarding cerebrovascular events (3.4% vs. 2.7% for SE and BE respectively, p=0.466), major vascular complications (4.2% vs. 3.0% for SE and BE respectively, p=0.251) and death to hospital discharge (1.6% vs. 2.9% for SE and BE respectively, p=0.117). One-year Kaplan-Meier estimated survival was similar between the two groups (88.7% for BE vs. 91.4% for SE valves, plog-rank=0.093). When adjusting for age, extensive calcification of the aorta and baseline LV function all caused mortality hazard ratios were similar between patients treated with BE vs SE valves (HR 1.39; 95% CI 0.97 to 1.98, p=0.07). Conclusions Real life comparison of the last generation balloon expandable and self-expanding devices demonstrates superiority of the former in terms of residual PVL, at the expense of higher transvalvular gradients and higher need of new PPM implantation. The latter however may represent differences in center practices with regards to thresholds for permanent pacing. Long-term follow-up and future larger trials are required to establish any potential long-term difference in clinical outcomes and prognosis. Funding Acknowledgement Type of funding sources: None.
Background: Assessing anatomic suitability for transcatheter mitral valve implantation (TMVI) can be time-consuming, particularly simulation of the neo-left ventricular outflow tract (neoLVOT), requires specialized software and computerized models of prostheses. The objective of this study is to assess CT-derived patient anatomic measurements for their ability to accurately differentiate between patients who were treated in a TMVI clinical study and those who were excluded due to anatomic concerns.
Introduction: There are few data on changes in left atrial (LA) and left ventricular (LV) volumes and functions after transcatheter mitral valve replacement (TMVR). This study aimed to describe the anatomical and functional changes in left-sided cardiac chambers by computed tomography angiography (CTA) from baseline to 1-month after TMVR with Tendyne prosthesis.
OBJECTIVES The aim of this study was to describe the anatomic and functional changes in left-sided chambers using computed tomographic angiography (CTA) from baseline to 1 month after transcatheter mitral valve replacement (TMVR) with the Tendyne prosthesis. BACKGROUND Data on changes in left atrial and left ventricular (LV) volumes after TMVR implantation are very limited. METHODS Patients who underwent TMVR with the Tendyne prosthesis between 2015 and 2018 were analyzed. Changes in LV end-diastolic volume, ejection fraction, LV mass, left atrial volume, and global longitudinal strain were assessed at baseline and 1 month after TMVR using CTA. Specific Tendyne implant characteristics were identified and correlated with remodeling changes. RESULTS A total of 36 patients (median age 74 years; interquartile range [IQR]: 69 to 78 years; 78% men; 86% with secondary mitral regurgitation) were included in this study. There were significant decreases in LV end-diastolic volume (281 ml [IQR: 210 to 317 ml] vs. 239 ml [IQR: 195 to 291 ml]; p < 0.001), LV ejection fraction (37% [IQR: 31% to 48%] vs. 30% [IQR: 23% to 40%]; p < 0.001), LV mass (126 g [IQR: 96 to 155 g] vs. 116 g [IQR: 92 to 140 g]; p < 0.001), left atrial volume (171 ml [IQR: 133 to 216 ml] vs. 159 ml [IQR: 125 to 201 ml]; p = 0.027), and global longitudinal strain (-11% [IQR: 17% to 8%] vs. -9% [IQR: 12% to -6%]; p < 0.001) from baseline to 1-month follow-up. Favorable LV end-diastolic volume reverse remodeling occurred in the majority (30 of 36 patients [83%]). Closer proximity of the Tendyne apical pad to the true apex (24 mm [IQR: 21 to 29 mm] vs. 35 mm [IQR: 26 to 40 mm]) was predictive of favorable remodeling (p = 0.037). CONCLUSIONS TMVR with Tendyne results in favorable left-sided chamber remodeling in the majority of patients treated, as detected on CTA at 1 month after implantation. CTA identifies favorable post-TMVR changes, which could be related to specific characteristics of the device implantation. (C) 2020 by the American College of Cardiology Foundation.
Global left ventricular electromechanical dyssynchrony (GLVD) is uncoordinated LV contraction that reduces the extent of intrinsic energy transfer from the myocardium to the circulation leading to a reduction in peak LV pressure rise, prolonged total isovolumic time (t-IVT) and fall in stroke volume [1]. This potentially important parameter is not routinely assessed in critically ill cardiothoracic patients.
We describe the 10-year outcome of the first-in-human series of 12 patients with hypertrophic cardiomyopathy treated with alcohol septal ablation. There was no 30-day mortality. Survival free of death, internal cardiac defibrillator discharge for treatment of ventricular fibrillation or tachycardia, severe New York Heart Association (NYHA) class III/IV and/or Canadian Cardiovascular Society class III/IV symptoms and the need for surgical myectomy in this cohort was 91% at 1 year and 73% at 10 years. The reduction in outflow tract gradient was maintained over the 10 years, from a mean preoperative gradient of 70 mm Hg to a median of 3 mm Hg at 126 months of follow-up (p < 0.01). Two patients (16%) underwent a further ablation procedure. Two patients (16%) suffered sudden cardiac death, 91 and 102 months after the procedure. Long-term symptom benefit was experienced by all patients, with a reduction in mean NYHA class from 2.7 ± 0.6 before the procedure to 1 after the procedure at the last follow-up (p < 0.01). This historic small cohort study demonstrates that septal ablation can provide long-term haemodynamic and symptomatic benefit.
Conclusions:In patients with atherosclerosis, the prevalence of AS is increased.This increase is related to age and to the coexistence of CAD and PAD.Thus, AS represents a marker of a more generalized atherosclerotic process in aging patients.0.74±0.13cm2, with peak and mean transvalvular gradients of 91±19 mm Hg and 57±13 mm Hg, respectively.Total exercise time was 5.24±2.6 minutes.The exercise test was abnormal in 67 patients.Symptoms developed in 48 patients: dyspnea in 38, angina in 9, dizziness in 5 and significant fatigue in 4. Abnormal blood pressure response to exercise was noted in 44 patients, and in 24 of them it was the only manifestation of test abnormality.ST segment depression >2 mm was observed in 7 patients.There was no sustained ventricular arrhythmia.There were no cases of syncope or other major complications.The post-exercise peak and mean transaortic pressure gradients were 113±24 mm Hg and 70±16 mm Hg respectively.An abnormal contractile response was observed in 12 patients and in 7 of them it was the only parameter of test abnormality.Sixty-four patients were followed up for 20.6±13.7 months.Of these, 41 underwent aortic valve replacement and in 23 (56%) of them the indication for surgery was based on the test result.Three patients died during follow-up, one of them while waiting for surgery.Conclusions: ESE under careful supervision is a safe and useful procedure for the evaluation of asymptomatic patients with severe AS.A large proportion of patients underwent aortic valve replacement based exclusively on the ESE results.