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1.
N Engl J Med ; 390(21): 1959-1971, 2024 Jun 06.
Article in English | MEDLINE | ID: mdl-38587261

ABSTRACT

BACKGROUND: Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR). METHODS: We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm2 or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority). RESULTS: A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan-Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% confidence interval [CI], -4.9 to 2.5; P<0.001 for noninferiority). The Kaplan-Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P<0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm2 and 1.50 cm2; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups. CONCLUSIONS: Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.).


Subject(s)
Aortic Valve Stenosis , Aortic Valve , Bioprosthesis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Female , Humans , Male , Aortic Valve/surgery , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/complications , Bioprosthesis/adverse effects , Heart Failure , Kaplan-Meier Estimate , Postoperative Complications/etiology , Prosthesis Design , Prosthesis Failure , Stroke/etiology , Transcatheter Aortic Valve Replacement/adverse effects
2.
Circulation ; 2024 Aug 05.
Article in English | MEDLINE | ID: mdl-39101203

ABSTRACT

BACKGROUND: Previous transcatheter valve therapy registry analyses of transcatheter mitral valve in valve (MViV) replacement of degenerated bioprosthesis reported early experience in the United States. Given recent increases in transseptal MViV volumes and introduction of the SAPIEN 3 Ultra valve, it is important to determine contemporary outcomes for patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV replacement. METHODS: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry was used to extract data for all patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV from 2015 to September 2022. Primary efficacy outcome was 1-year all-cause mortality. Secondary end points included 30-day mortality, functional class, quality of life, and mitral valve performance. Primary safety outcomes were device success and in-hospital complications. RESULTS: A total of 4243 patients with a mean STS score of 9.2±7.7 underwent transseptal MViV at 455 sites. The rate of Mitral Valve Academic Research Consortium technical (96.6%) success was high, and procedural complications were low. All-cause in-hospital, 30-day, and 1-year mortality rates were 3.2%, 4.3%, and 13.4%, respectively. Significant improvements in New York Heart Association class (New York Heart Association I/II, 18% to 87%) and quality of life (Kansas City Cardiomyopathy Questionnaire score, 38 to 78) were noted at 1 year (P<0.0001 for both) after MViV. Upon stratifying by STS scores, it was observed that the low-risk group (STS<4) had a significantly lower in-hospital mortality rate of 0.4%, whereas the intermediate-risk group (STS, 4-8) had an in-hospital mortality rate of 1.9%. From 2015 to 2022, the number of transseptal MViV cases/year increased significantly, whereas procedure times, length of stay, and intensive care unit hours shortened significantly. At the same time, there was a significant trend toward reduced in-hospital (P=0.0005), 30-day (P=0.004), and 1-year mortality rates (P=0.01). CONCLUSIONS: This multicenter, prospective study reports excellent procedural outcomes, 1-year mortality rates, and a significant improvement in quality of life for patients undergoing transseptal MViV in the contemporary era. Patients in the low-risk and intermediate-risk STS score categories had significantly better outcomes compared with those in the high-risk category. MViV is a reasonable therapy for the majority of patients with degenerated bioprosthetic mitral valves, who are anatomical candidates.

3.
Catheter Cardiovasc Interv ; 101(3): 605-609, 2023 02.
Article in English | MEDLINE | ID: mdl-36718052

ABSTRACT

BACKGROUND: Elevated transmitral gradient post transcatheter mitral valve edge-to-edge repair (TEER) has been associated with worse outcomes. Whether an elevated baseline transmitral diastolic mean gradient (MG) ≥5 mmHg is associated with hemodynamic outcomes after TEER is unknown. METHODS: A total of 164 consecutive patients undergoing TEER at Mayo Clinic between June 2014 and May 2018 were analyzed in this retrospective study. Baseline demographics, as well as clinical, echocardiographic, and procedural data were obtained. Data on direct left atrial pressure (LAP) before and after TEER were recorded. Logistic regression models were constructed to evaluate the association between preprocedure transmitral diastolic mean gradient (pre-MG) and (1) improvement in LAP following TEER, (2) postprocedure transmitral diastolic mean gradient (post-MG). A decrease in LAP post TEER was considered an improvement in hemodynamic response. Pre-MG was categorized as: ≥5 and <5 mmHg. RESULTS: Median age of the cohort was 81.5 years (Q1: 76.3, Q3: 87) and 34% were female. At baseline, median transmitral diastolic MG was 4 mmHg (Q1: 3, Q3: 5) and median LAP was 19 mmHg (Q1:16, Q3: 23.5). In a multivariable model, adjusted for age and sex, patients with pre-MG ≥ 5 mmHg were less likely to see an improvement in LAP post TEER (adjusted odds ratio [aOR]: 0.22, 95% confidence interval [CI]: 0.09, 0.55; p = 0.001) and more likely to have elevated post-MG (aOR; 7.08, 95% CI: 2.93, 17.13; p < 0.001). CONCLUSION: Higher pre-MG (≥5 mmHg) was associated with a lower reduction in LAP and higher residual transmitral gradient following TEER suggesting other potential contributors to increased LAP besides mitral regurgitation as a cause of elevated baseline MG.


Subject(s)
Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Humans , Female , Aged, 80 and over , Male , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Atrial Pressure , Retrospective Studies , Treatment Outcome , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/surgery
4.
Catheter Cardiovasc Interv ; 101(6): 1120-1127, 2023 05.
Article in English | MEDLINE | ID: mdl-37017419

ABSTRACT

BACKGROUND: Improvement in left atrial pressure (LAP) during transcatheter edge-to-edge repair (TEER) is associated with improved outcomes. We sought to investigate the predictors of optimal hemodynamic response to TEER. METHODS: We identified patients who underwent TEER at Mayo Clinic between May 2014 and February 2022. Patients with missing LAP data, an aborted procedure, and those undergoing a concomitant tricuspid TEER were excluded. We performed a logistic regression analysis to identify predictors of optimal hemodynamic response to TEER (defined as LAP ≤ 15 mmHg). RESULTS: A total of 473 patients were included (Mean age 78.5 ± 9.4 years, 67.2% males). Overall, 195 (41.2%) achieved an optimal hemodynamic response after TEER. Patients who did not achieve an optimal response had higher baseline LAP (20.0 [17-25] vs. 15.0 [12-18] mmHg, p < 0.001), higher prevalence of AF (68.3% vs. 55.9%, p = 0.006), functional MR (47.5% vs. 35.9%, p = 0.009), annular calcification (41% vs. 29.2%, p = 0.02), lower left ventricular EF (55% vs. 58%, p = 0.02), and more frequent postprocedural severe MR (11.9% vs. 5.1%, p = 0.02) and elevated mitral gradient >5 mmHg (30.6% vs. 14.4%, p < 0.001). In the multivariate logistic regression analysis, AF (OR = 0.58; 95% CI = 0.35-0.96; p = 0.03), baseline LAP (OR = 0.80; 95% CI = 0.75-0.84; p < 0.001) and postprocedural mitral gradient <5 mmHg (OR = 0.35; 95% CI = 0.19-0.65; p < 0.001), were independent predictors of achieving an optimal hemodynamic response. In the multivariate model, residual MR was not independently associated with optimal hemodynamic response. CONCLUSIONS: Optimal hemodynamic response is achieved in 4 in 10 patients undergoing TEER. AF, higher baseline LAP, and higher postprocedural mitral gradient were negative predictors of optimal hemodynamic response after TEER.


Subject(s)
Calcinosis , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Male , Humans , Aged , Aged, 80 and over , Female , Treatment Outcome , Hemodynamics , Heart Ventricles , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/surgery , Heart Valve Prosthesis Implantation/adverse effects
5.
Circulation ; 143(2): 104-116, 2021 01 12.
Article in English | MEDLINE | ID: mdl-32975133

ABSTRACT

BACKGROUND: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. METHODS: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate. RESULTS: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (P<0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (P=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P<0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P=0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P=0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P=0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88-21.53; P<0.001) were both independently associated with repeat mitral valve replacement. CONCLUSIONS: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.


Subject(s)
Heart Valve Diseases/surgery , Heart Valve Prosthesis/standards , Mitral Valve/surgery , Registries , Reoperation/standards , Transcatheter Aortic Valve Replacement/standards , Aged , Aged, 80 and over , Female , Follow-Up Studies , Heart Valve Diseases/diagnostic imaging , Heart Valve Prosthesis/trends , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/trends , Humans , Internationality , Male , Middle Aged , Mitral Valve/diagnostic imaging , Reoperation/trends , Retrospective Studies , Transcatheter Aortic Valve Replacement/trends
6.
Lancet ; 397(10292): 2385-2438, 2021 06 19.
Article in English | MEDLINE | ID: mdl-34010613

ABSTRACT

Cardiovascular disease is the leading cause of death in women. Decades of grassroots campaigns have helped to raise awareness about the impact of cardiovascular disease in women, and positive changes affecting women and their health have gained momentum. Despite these efforts, there has been stagnation in the overall reduction of cardiovascular disease burden for women in the past decade. Cardiovascular disease in women remains understudied, under-recognised, underdiagnosed, and undertreated. This Commission summarises existing evidence and identifies knowledge gaps in research, prevention, treatment, and access to care for women. Recommendations from an international team of experts and leaders in the field have been generated with a clear focus to reduce the global burden of cardiovascular disease in women by 2030. This Commission represents the first effort of its kind to connect stakeholders, to ignite global awareness of sex-related and gender-related disparities in cardiovascular disease, and to provide a springboard for future research.


Subject(s)
Cardiovascular Diseases , Cost of Illness , Goals , Internationality , Women's Health , Awareness , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/mortality , Female , Humans , Risk Factors , Socioeconomic Factors , Women's Health/statistics & numerical data , Women's Health/trends
7.
Am Heart J ; 243: 92-102, 2022 01.
Article in English | MEDLINE | ID: mdl-34587510

ABSTRACT

BACKGROUND: The SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial was designed to compare the performance of the two most widely available commercial transcatheter aortic valve replacement (TAVR) devices in patients with symptomatic severe native aortic stenosis with a small aortic valve annulus undergoing transfemoral TAVR. Patients with small aortic valve annuli are typically female and are often underrepresented in clinical trials. METHODS: The SMART Trial is an international, prospective, multi-center, randomized controlled, post-market trial. The trial will be conducted in approximately 700 subjects at approximately 90 sites globally. Inclusion criteria include severe aortic stenosis, aortic valve annulus area of ≤430 mm2 based on multi-detector computed tomography, and appropriate anatomy for both the Medtronic Evolut PRO/PRO+ self-expanding and Edwards SAPIEN 3/3 Ultra balloon-expandable devices. The primary clinical outcome composite endpoint is defined as mortality, disabling stroke or heart failure rehospitalization at 12 months. The co-primary valve function composite endpoint is defined as bioprosthetic valve dysfunction at 12 months which includes hemodynamic structural valve dysfunction, defined as a mean gradient ≥20 mmHg, non-structural valve dysfunction, defined as severe prothesis-patient mismatch or ≥moderate aortic regurgitation, thrombosis, endocarditis, and aortic valve re-intervention. Powered secondary endpoints will be assessed hierarchically. CONCLUSIONS: The SMART trial will be the largest head-to-head comparative trial of transfemoral TAVR using the two most widely available contemporary TAVR devices in the setting of small aortic annuli and the largest trial to enroll primarily women. CLINICAL TRIAL REGISTRATION: URL: www.clinicaltrials.gov, Unique identifier: NCT04722250.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Female , Humans , Prospective Studies , Prosthesis Design , Risk Factors , Severity of Illness Index , Transcatheter Aortic Valve Replacement/methods , Treatment Outcome
8.
Catheter Cardiovasc Interv ; 99(5): 1659-1665, 2022 04.
Article in English | MEDLINE | ID: mdl-35019211

ABSTRACT

BACKGROUND: Transcatheter mitral valve replacement (TMVR) has emerged as a feasible alternative to redo surgical mitral valve replacement (SMVR) in patients with degenerated mitral prostheses, with limited comparative data. METHODS: We compared mid-term outcomes in patients with degenerated mitral valve prostheses treated with TMVR or redo SMVR. The primary endpoint was survival at 5 years of follow-up. RESULTS: From 2014 to 2020, 215 patients presented with degenerated mitral valve prostheses. Of whom 86 (40%) were treated with TMVR (75[87%] valve-in-valve and 11[13%] valve-in-ring), while 129 patients (60%) underwent SMVR. The TMVR cohort was older (p < 0.0001), more symptomatic (p = 0.0003) and had more chronic lung disease (p = 0.02), worse renal function (p = 0.02) and higher right ventricular systolic pressures (p < 0.0001). Thirty-day mortality was lower with TMVR versus SMVR (2.4% vs. 10.2%, OR4.69 [95% CI 1.25-30.5], p = 0.04) with probability of mortality at 1, 2, and 5 years being 14.7% versus 17.5%, 24.5% versus 20.7%, and 49.9% versus 34.0%, respectively. Mode of prosthesis degeneration, baseline hemodynamics, and valve selection did not appreciably impact outcomes. CONCLUSIONS: TMVR for degenerated mitral prostheses is associated with better early survival compared to SMVR despite a greater burden of comorbidities. In contrast, 5 year survival rates appear more favorable with SMVR, which may reflect the lower baseline risk of this population. Clinical, hemodynamic, and echocardiographic follow-up support the mid-term durability of TMVR for degenerated mitral prostheses. Further dedicated studies, however, are required to optimize outcomes in this challenging patient cohort and to navigate the choice of approach for each individual patient.


Subject(s)
Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Mitral Valve Insufficiency , Cardiac Catheterization/adverse effects , Heart Valve Prosthesis Implantation/adverse effects , Humans , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/etiology , Mitral Valve Insufficiency/surgery , Treatment Outcome
9.
Catheter Cardiovasc Interv ; 99(5): 1647-1658, 2022 04.
Article in English | MEDLINE | ID: mdl-35019204

ABSTRACT

OBJECTIVES: To assess the impact of pulmonary hypertension (PH) on outcomes of patients with severe mitral annular calcification (MAC) undergoing transcatheter mitral valve replacement (TMVR). BACKGROUND: PH is associated with poor outcomes after mitral valve surgery. Whether the presence of PH in patients with MAC undergoing (TMVR) is associated with poor outcomes, is unknown. METHODS: Retrospective evaluation of 116 patients from 51 centers in 11 countries who underwent TMVR with valve in mitral annular calcification (ViMAC) using balloon-expandable aortic transcatheter valves (THVs) from September 2012 to March 2017. Pulmonary artery systolic blood pressure (PASP) by echocardiogram was available in 90 patients. The subjects were stratified based on PASP: No PH = PASP ≤35 mmHg (n = 11); mild to moderate PH = PASP 36-49 mmHg (n = 21) and severe PH = PASP ≥50 mmHg (n = 58). Clinical, procedural, and echocardiographic outcomes were assessed. RESULTS: Mean age was 72.7 (±12.8) years, 59 (65.6%) were female, Society of Thoracic Surgeons score was 15.8 + 11.8% and 90.0% where in New York Heart Association (NYHA) class III-IV. There was no significant difference in all-cause mortality at 30 days (no PH = 27.3%, mild-moderate PH = 19.0%, severe PH = 31.6%; p = 0.55) or at 1 year (no PH = 54.5%, mild-moderate PH = 38.1%, severe PH = 56.1%; p = 0.36). No difference in adverse events, NYHA class or amount of residual mitral regurgitation at 1 year were observed between the groups. CONCLUSION: This study suggests that the presence of PH in patients with predominantly mitral stenosis with MAC undergoing TMVR does not impact mortality or adverse events. Further studies are needed to fully understand the effect of PH in this group of patients.


Subject(s)
Calcinosis , Heart Valve Diseases , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Hypertension, Pulmonary , Mitral Valve Insufficiency , Aged , Calcinosis/complications , Calcinosis/diagnostic imaging , Calcinosis/surgery , Cardiac Catheterization/adverse effects , Female , Heart Valve Diseases/surgery , Heart Valve Prosthesis Implantation/adverse effects , Humans , Hypertension, Pulmonary/diagnostic imaging , Hypertension, Pulmonary/etiology , Hypertension, Pulmonary/surgery , Male , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/etiology , Mitral Valve Insufficiency/surgery , Retrospective Studies , Treatment Outcome
10.
Catheter Cardiovasc Interv ; 99(6): 1807-1816, 2022 05.
Article in English | MEDLINE | ID: mdl-35066988

ABSTRACT

OBJECTIVES: To compare all-cause mortality in patients with mitral annulus calcification (MAC) and severe mitral valve dysfunction (MVD) who received standard mitral intervention versus no intervention. BACKGROUND: Patients with MAC often have high surgical risk due to advanced age, comorbidities, and technical challenges related to calcium. The impact of a mitral intervention on outcomes of patients with MAC and severe MVD is not well known. METHODS: Retrospective review of patients with MAC by transthoracic echocardiography (TTE) in 2015 at a single institution. Patients with severe mitral stenosis (MS) or regurgitation (MR) were analyzed and stratified into two groups: surgical or transcatheter intervention performed <1 year after the index TTE, and no or later intervention. The primary endpoint was all-cause mortality. RESULTS: Of 5502 patients with MAC, 357 had severe MVD (MS = 27%, MR = 73%). Of those, 108 underwent mitral intervention (surgery = 87; transcatheter = 21). They were younger (73 ± 11 vs. 76 ± 11 years, p < 0.01) and less frequently had cardiovascular diseases compared with no-intervention. Frequency in women was similar (45% vs. 50%, p = 0.44). During median follow-up of 3.2 years, the intervention group had higher estimated survival than those without intervention (80% vs. 72% at 1 year and 55% vs. 35% at 4 year, p < 0.01). Adjusted for age, eGFR, LVEF < 50%, and pulmonary hypertension, mitral intervention was an independent predictor of lower mortality (hazard ratio = 0.66, 95% confidence interval 0.43-0.99, p = 0.046). CONCLUSION: Patients with MAC and severe MVD who underwent mitral intervention <1 year from index TTE had lower mortality than those without intervention. Mitral intervention was independently associated with lower mortality.


Subject(s)
Calcinosis , Heart Valve Diseases , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Mitral Valve Stenosis , Calcinosis/diagnostic imaging , Calcinosis/surgery , Female , Heart Valve Diseases/surgery , Heart Valve Prosthesis Implantation/adverse effects , Humans , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/surgery , Mitral Valve Stenosis/complications , Mitral Valve Stenosis/diagnostic imaging , Mitral Valve Stenosis/therapy , Retrospective Studies , Treatment Outcome
11.
Catheter Cardiovasc Interv ; 100(1): 133-142, 2022 07.
Article in English | MEDLINE | ID: mdl-35535629

ABSTRACT

BACKGROUND: Mitral transcatheter edge-to-edge repair (MTEER) is an established therapeutic approach for mitral regurgitation (MR). Functional mitral regurgitation originating from atrial myopathy (A-FMR) has been described. OBJECTIVES: We sought to assess the clinical, echocardiographic and hemodynamic considerations in A-FMR patients undergoing MTEER. METHODS: From 2014 to 2020, patients undergoing MTEER for degenerative MR (DMR), functional MR (FMR), and mixed MR were assessed. A-FMR was defined by the presence of MR > moderate in severity; left ventricular (LV) ejection fraction (LVEF) ≥ 50%; and severe left atrial (LA) enlargement in the absence of LV dysfunction, leaflet pathology, or LV tethering. The diagnosis of A-FMR (vs. ventricular-FMR [V-FMR]) was confirmed by three independent echocardiographers. Baseline characteristics, procedural outcomes as well as clinical and echocardiographic follow-up are reported. Device success was defined as final MR grade ≤ moderate; MR reduction ≥1 grade; and final transmitral gradient <5 mmHg. RESULTS: 306 patients underwent MTEER, including DMR (62%), FMR (19%), and mixed MR (19%). FMR cases included 37 (63.8%) V-FMR and 21 (36.2%) A-FMR. Tricuspid regurgitation (≥ moderate) was higher in A-FMR (80.1%) compared to V-FMR (54%) and DMR (42%). Device success did not significantly differ between A-FMR and V-FMR (57% vs. 73%, p = 0.34) or DMR (57% vs. 64%, p = 1.0). The A-FMR cohort was less likely to achieve ≥3 grades of MR reduction compared to V-FMR (19% vs. 54%, p = 0.01) and DMR (19% vs. 49.7%, p = 0.01). Patients with V-FMR and DMR demonstrated significant reductions in mean left atrial pressure (LAP) and peak LA V-wave, though A-FMR did not (LAP -0.24 ± 4.9, p = 0.83; peak V-wave -1.76 ± 9.1, p = 0.39). In follow-up, echocardiographic and clinical outcomes were similar. CONCLUSIONS: In patients undergoing MTEER, A-FMR represents one-third of FMR cases. A-FMR demonstrates similar procedural success but blunted acute hemodynamic responses compared with DMR and V-FMR following MTEER. Dedicated studies specifically considering A-FMR are needed to discern the optimal therapeutic approaches.


Subject(s)
Cardiac Surgical Procedures , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Heart Valve Prosthesis Implantation/adverse effects , Humans , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/surgery , Retrospective Studies , Treatment Outcome
12.
Catheter Cardiovasc Interv ; 99(3): 861-866, 2022 02.
Article in English | MEDLINE | ID: mdl-34388299

ABSTRACT

OBJECTIVES: The aim of this study was to determine the safety of eliminating the pre-discharge transthoracic echocardiogram (TTE) on 30-day outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: TTE is utilized before, during, and after TAVR. Post-procedural, pre-discharge TTE assists in assessment of prosthesis function and detection of clinically significant paravalvular leak (PVL) after TAVR. METHODS: Patients who underwent TAVR at Mayo Clinic from July 2018 to July 2019 were included in a prospective institutional registry. Patients undergoing TAVR prior to February 2019 received a pre-discharge TTE, while those undergoing TAVR after February 2019 did not. Both cohorts were evaluated with TTE at 30 days post-TAVR. RESULTS: A total of 330 consecutive patients were included. Of these, 160 patients (age 81.1 ± 7.6) had routine pre-discharge TTE, while 170 patients (age 78.9 ± 7.5) were dismissed without routine pre-discharge TTE. Mortality at 30 days was similar between the two groups (0% and 1.2%, respectively). One episode of PVL requiring intervention (0.6%) occurred in the pre-discharge TTE group and none in the group without pre-discharge TTE at 30-day follow-up. There was a similar incidence of total composite primary and secondary adverse events between the cohort receiving a pre-discharge TTE and those without (28.1% vs. 25.3%, P = 0.56) at 30 days. The most common event was need for permanent pacemaker or ICD implantation in both groups (13.1% vs. 11.8%, P = 0.71). CONCLUSIONS: Elimination of the pre-discharge TTE is safe and associated with comparable 30-day outcomes to routine pre-discharge TTE. These findings have implication for TAVR practice cost-efficiency and health care utilization.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Humans , Patient Discharge , Prospective Studies , Retrospective Studies , Risk Factors , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
13.
Am J Community Psychol ; 70(3-4): 394-406, 2022 12.
Article in English | MEDLINE | ID: mdl-35848150

ABSTRACT

Substance use disorders are increasingly prevalent among veterans in the United States. Veterans in recovery face unique challenges, such as high rates of psychiatric comorbidities, difficulties adjusting to civilian life, and inadequate housing and mental health services. While prior research has explored veterans' experiences in recovery, studies have not implemented a multilevel perspective in their analyses. The current qualitative study examined how individual veteran experiences intersect with interpersonal and systemic factors. Semistructured focus groups were conducted with veterans who were former or current residents of recovery homes (N = 20). Thematic analysis was utilized to explore veterans' personal experiences through the CHIME-D framework (connectedness, hope & optimism, identity, meaning in life, empowerment, and difficulties). The data were further analyzed within a socioecological model (intrapersonal, interpersonal, and community). Each component of the CHIME-D framework was salient across all focus groups, with connectedness, empowerment, and difficulties being the most prominent themes that occurred across all socioecological levels. Results suggest that recovery initiatives can effectively assist veterans by promoting empowerment, facilitating social connections, and addressing cooccurring difficulties across multiple socioecological contexts. Additionally, treatment programs should encourage veterans to take on meaningful roles in their communities. Future research should continue to explore veterans' recovery experiences using a socioecological model.


Subject(s)
Mental Health Services , Substance-Related Disorders , Veterans , Humans , United States , Veterans/psychology , Substance-Related Disorders/epidemiology , Optimism , Focus Groups
14.
J Community Psychol ; 50(3): 1616-1625, 2022 04.
Article in English | MEDLINE | ID: mdl-34709666

ABSTRACT

Oxford Houses (OHs) are a large network of self-run community-based settings for individuals with substance use disorders. This present study explored a model based on conceptualizing recovery home social systems as dynamic multirelational (multiplex) social networks. The model is developed from data obtained from 42 OH recovery homes in three parts of the US, addressing whole networks of friendship, close friendship, and willingness to loan money. Findings indicated that close friend and loan relationships mutually reinforced each other over time as they coevolved. These types of insights can help community psychologists to better understand complex network dynamics in community-based settings.


Subject(s)
Friends , Substance-Related Disorders , Humans , Social Integration , Social Networking
15.
Mil Psychol ; 34(2): 252-259, 2022.
Article in English | MEDLINE | ID: mdl-38536240

ABSTRACT

The success of service members' transition from military to civilian life is an ongoing concern for their personal well-being, for their families, and for our communities. There is a need for interventions to promote improved social integration. This one-arm feasibility study examined the ease of use, satisfaction, and desire for social interaction in response to the Warrior Spirit/Mission Homefront (WS/MH) self-guided dialogue program, which facilitates conversations among small groups of fellow service members through gamified activities (N = 299 service members). Through the use of a specially designed card deck and game, service members answer questions written to elicit responses about themselves and their military service. WS/MH dialogs and discussions model how persons can speak about deployment and military service with others. These discussions facilitate the articulation of experiences across a range of difficulties - according to persons' own comfort threshold - in order to cultivate language that can translate to conversations with which to reconnect with family and community. The activity demonstrated high satisfaction, and yielded the anticipated increases in positive emotion (p = .013) and desire for social interaction (p = .001) in pre-post comparisons. Satisfaction was associated with change in positive emotions and change in willingness to talk with others. This provides initial evidence of good feasibility and satisfaction with WS/MH, as a promising and readily scalable tool in the ongoing efforts to improve service members' and Veterans' social interactions, belongingness and emotional well-being as they come home.

16.
J Soc Work Pract Addict ; 22(4): 320-333, 2022.
Article in English | MEDLINE | ID: mdl-36686032

ABSTRACT

Recovery homes may facilitate individuals with substance use disorders re-integration back into community settings by providing friendship, resources, and advice. Participants of the current study were over 600 residents of 42 Oxford House recovery homes. Findings indicated that willingness to share resources in the form of loans was associated with higher levels of house involvement in recovery home chapters. Active involvement in house and community affairs may influence more recovery within homes or may be an indicator of houses with residents with more capacities and skills for positive long-term health outcomes. Such findings suggest that recovery is a dynamic process with multiple ecological layers embedding individuals, their immediate social networks, and the wider community.

17.
Catheter Cardiovasc Interv ; 97(7): E992-E1001, 2021 06 01.
Article in English | MEDLINE | ID: mdl-33002271

ABSTRACT

OBJECTIVES: We aimed to investigate the invasive hemodynamic changes with transcatheter mitral valve replacement (TMVR) in patients with severe mitral stenosis due to severe mitral annular calcification. BACKGROUND: The hemodynamic response to TMVR in patients with mitral stenosis related to degenerative mitral annular calcification has not been fully elucidated. METHODS: We conducted retrospective review of patients who underwent successful transseptal TMVR with balloon-expandable valves for symptomatic severe mitral stenosis due to mitral annular calcification at our institution between January 2014 and February 2020. Invasive hemodynamic measurements were obtained both before valve implantation (predeployment) and after (postdeployment). RESULTS: Eighteen patients (age 72 ± 10 years, 44% female) were included for the analysis. There was a significant reduction in mean left atrial pressure (23.7 ± 5.6 mmHg versus 20.6 ± 4.8 mmHg; p = .01), left atrial v-wave (mean 39.3 ± 10.2 mmHg versus 32.9 ± 9.9 mmHg; p = .01), and an increase in systemic mean blood pressure (72.6 mmHg ±11.2 versus 79.5 ± 9.9 mmHg; p = .02) postdeployment compared to predeployment. Patients who had symptom improvement at 30-day follow-up tended to have greater reduction in mean left atrial pressure (4.4 ± 4.4 mmHg versus 0.5 ± 5.2 mmHg; p = .16) and v-wave (8.6 ± 9.0 mmHg versus 0.7 ± 8.4 mmHg; p = .10) compared to those who did not experience improvement of symptoms. CONCLUSIONS: Transseptal TMVR for severe mitral stenosis due to mitral annular calcification is associated with reductions in mean left atrial pressure and left atrial v-wave, and an increase in systemic arterial pressure.


Subject(s)
Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Mitral Valve Stenosis , Aged , Aged, 80 and over , Cardiac Catheterization , Female , Heart Valve Prosthesis Implantation/adverse effects , Hemodynamics , Humans , Male , Middle Aged , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Mitral Valve Stenosis/complications , Mitral Valve Stenosis/diagnostic imaging , Mitral Valve Stenosis/surgery , Retrospective Studies , Treatment Outcome
18.
Catheter Cardiovasc Interv ; 98(4): 776-785, 2021 10.
Article in English | MEDLINE | ID: mdl-34057272

ABSTRACT

OBJECTIVES: To determine the incidence, characteristics, and outcomes of patients with hemolysis after transcatheter mitral valve replacement (TMVR). BACKGROUND: Hemolysis is an increasingly recognized complication of TMVR. Clinical outcomes and optimal management for patients with hemolysis after TMVR are unclear. METHODS: Patients that underwent mitral valve-in-valve (MViV), valve-in-ring (MViR), and valve-in-mitral annular calcification (ViMAC) at a single center were retrospectively assessed. RESULTS: A total of 101 patients had TMVR, including 69 with MViV, 14 with MViR, and 18 with ViMAC. ViMAC patients had an increased frequency of mild or greater paravalvular leak (PVL) (ViMAC, 72.2%; MViR, 14.3%; MViV, 13.0%; p < .001). Hemolysis occurred in eight patients and was more common after ViMAC (ViMAC, 33.3%; MViR, 7.1%; MViV, 1.5%; p < .001). This required transfusion in five (ViMAC, 4; MViV, 1) and was associated with acute kidney injury in five with ViMAC. Among the ViMAC patients, four had transcatheter re-intervention to treat hemolysis with resolution of anemia in three and mild residual anemia in one with persistent mild PVL. The two ViMAC patients without re-intervention had persistent anemia and died within 6 months. Both MViV and MViR patients with hemolysis did not have PVL but had turbulent flow from left ventricular outflow tract narrowing and their hemolysis was self-limited. CONCLUSIONS: Hemolysis occurs with greater frequency and increased clinical severity after ViMAC as compared to MViV or MViR and is likely related to increased incidence of PVL. These findings demonstrate the need to investigate novel strategies that can reduce the burden of hemolysis with ViMAC.


Subject(s)
Bioprosthesis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Mitral Valve Annuloplasty , Cardiac Catheterization/adverse effects , Heart Valve Prosthesis Implantation/adverse effects , Hemolysis , Humans , Incidence , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Retrospective Studies , Treatment Outcome
19.
Catheter Cardiovasc Interv ; 98(4): E602-E609, 2021 10.
Article in English | MEDLINE | ID: mdl-33539045

ABSTRACT

BACKGROUND: Surgical intervention in patients with native mitral disease due to severe mitral annular calcification (MAC) carries significant risk. Transcatheter mitral valve replacement (TMVR) using balloon-expandable aortic transcatheter heart valve (THV) in MAC had emerged as alternative treatment. OBJECTIVES: We aim to study the temporal change in clinical outcomes of the procedure at a single center. METHODS: We retrospectively studied 23 patients who underwent TMVR in MAC at Mayo Clinic from January, 14, 2014 to March, 15, 2019. Cases were divided into early (n = 11) and late (n = 12) experience. The primary end point was 30-day all-cause mortality. The secondary end points were immediate technical success, 30-day procedural success, and 1-year all-cause mortality. RESULTS: Mean age of patients was 75.2 ± 8.9 years and 17 (74.0%) were female. Median STS score for 30-day mortality was 8 (Interquartile range 4.3-13.4) for the entire population. Immediate technical success was achieved in 21 out of 23 patients (two failures in the early experience were related to tamponade and procedural death). Thirty-day procedural success was higher in the late experience (10 out of 12 patients) compared to early experience (5 out of 11 patients, p = .06). Four deaths in the first 30-days were observed in the early experience while all patients survived to hospital discharge in the late experience (p = .01). CONCLUSIONS: Procedural success and 30-day survival of transcatheter mitral valve replacement in severe mitral annular calcification procedure using balloon-expandable aortic prosthesis had improved over the years. This is likely attributed to significant advancement in procedural planning, valve design, and techniques.


Subject(s)
Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Aged , Aged, 80 and over , Cardiac Catheterization/adverse effects , Female , Heart Valve Prosthesis Implantation/adverse effects , Humans , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Retrospective Studies , Treatment Outcome
20.
Catheter Cardiovasc Interv ; 98(6): E932-E937, 2021 11 15.
Article in English | MEDLINE | ID: mdl-34245208

ABSTRACT

BACKGROUND: The predictors and clinical significance of increased Doppler-derived mean diastolic gradient (MG) following transcatheter edge-to-edge mitral valve repair (MVTEER) remain controversial. OBJECTIVE: We sought to examine baseline correlates of Doppler-derived increased MG post-MVTEER and its impact on intermediate-term outcomes. METHODS: Patients undergoing MVTEER were analyzed retrospectively. Post-MVTEER increased MG was defined as >5 mmHg or aborted clip implantation due to increased MG intraprocedurally. Baseline MG and 3D-guided mitral valve area (MVA) by planimetry were retrospectively available in 233 and 109 patients. RESULTS: 243 patients were included; 62 (26%) had MG > 5 mmHg post-MVTEER or aborted clip insertion, including 7 (11%) that had aborted clip implantation. Mortality occurred in 63 (26%) during a median follow up of 516 days (IQR 211, 1021). Increased post-MVTEER MG occurred more frequently in females (44% vs. 16%, p < 0.001), those with baseline MVA <4.0 cm2 (71% vs. 16%), baseline MG ≥4 mmHg (61% vs. 20%), or multiple clips implanted (33% vs. 21%, p = 0.04). Increased post-MVTEER MG was associated with increased subsequent mortality compared to those with normal gradient (HR 1.91 95% CI 1.15-3.18 p = 0.016) as was aborted clip insertion compared to all others (HR 5.23 95% CI 2.06-13.28 p < 0.001). CONCLUSIONS: Smaller baseline MVA and increased baseline MG are associated with increased MG post-MVTEER and patients with a Doppler-derived post-MVTEER MG >5 mmHg suffered excess subsequent mortality. In high risk patients considered for MVTEER, identification of those at risk of iatrogenic mitral stenosis with MVTEER is important as they may be optimally treated with alternate surgical or transcatheter therapies.


Subject(s)
Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Mitral Valve Stenosis , Cardiac Catheterization/adverse effects , Female , Humans , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/etiology , Mitral Valve Insufficiency/surgery , Mitral Valve Stenosis/surgery , Retrospective Studies , Treatment Outcome
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