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1.
Am J Cardiol ; 223: 7-14, 2024 May 23.
Article En | MEDLINE | ID: mdl-38788821

The frequency and effectiveness of repeat mitral valve interventions (RMVI) after transcatheter edge-to-edge repair (TEER) for secondary mitral regurgitation (MR) are unknown. We aimed to examine the rate of and outcomes after RMVI after TEER in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial. Only 3.9% of COAPT trial patients required a repeat mitral valve intervention during 4-year follow-up which was successful in 90% of cases but was associated with an increased rate of heart failure (HF) hospitalizations (HFH). The COAPT trial randomized HF patients with severe secondary MR to TEER with the MitraClip device plus guideline-directed medical therapy (GDMT) versus GDMT alone. We evaluated the characteristics and outcomes of patients who had an RMVI during 4-year follow-up. A MitraClip implant was attempted in 293 patients randomized to TEER+GDMT, 10 of whom underwent an RMVI procedure (9 repeat TEER and 1 surgical mitral valve replacement) after 4 years of follow-up (cumulative incidence 3.90%, 95% confidence interval [CI] 2.08 to 7.08; median 182 days after the initial procedure). Patients with RMVI had larger mitral annular diameters, fewer clips implanted, and were more likely to have ≥3+MR at discharge compared with those without RMVI. Reasons for RMVI included failed index procedure because of difficult transseptal puncture (n = 2) or tamponade (n = 1); residual or recurrent severe MR after an initially successful procedure (n = 5); partial clip detachment (n = 1); and site-assessed mitral stenosis (n = 1). RMVI was successful in 8/10 (80%) patients. Patients who underwent RMVI had higher 4-year rates of HFH but similar mortality compared with those without RMVI. The annualized incidence rates of all HFH in patients who underwent RMVI were 234 events per 100 person-years (95% CI 139 to 395) pre-RMVI and 46 per 100 person-years (95% CI 25 to 86) post-RMVI as compared with 32 events per 100 patient-years (95% CI 28 to 36) in patients without RMVI. The rate ratio of HFH was reduced after RMVI in patients who underwent RMVI (0.20, 95% CI 0.09 to 0.45). In conclusion, the cumulative incidence of RMVI after 4 years was 3.9% in patients who underwent TEER for severe secondary MR in the COAPT trial. Patients who underwent RMVI were at increased risk of HFH which was reduced after the RMVI procedure. Clinical Trial Registration: Clinical Trial Name: Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) (COAPT) ClinicalTrial.gov Identifier: NCT01626079 URL:https://clinicaltrials.gov/ct2/show/NCT01626079.

2.
Struct Heart ; 8(1): 100225, 2024 Jan.
Article En | MEDLINE | ID: mdl-38283566

Background: Baseline left ventricular diastolic dysfunction (LVDD) is associated with poor health status in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), but health status improvement after TAVR appears similar across all grades of LVDD. Here, we aim to examine the relationship between changes in LVDD severity and health status outcomes following TAVR. Methods: Patients who underwent TAVR and had evaluable LVDD at both baseline and 1 year in the PARTNER (Placement of Aortic Transcatheter Valves) 2 SAPIEN 3 registries and PARTNER 3 trial were analyzed. LVDD grade was evaluated using echocardiography core lab data and an adapted definition of American Society of Echocardiography guidelines. Health status was assessed using the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score. The association between ΔLVDD severity and ΔKCCQ-OS was examined using linear regression models adjusted for baseline KCCQ-OS. Results: Of 1100 patients, 724 (65.8%), 283 (25.7%), and 93 (8.5%) had grade 0/1, 2, and 3 LVDD at baseline, respectively. At 1 year, LVDD severity was unchanged in 790 (71.8%) patients, improved in 189 (17.2%), and worsened in 121 (11.0%). Among 376 patients with baseline grade 2 or 3 LVDD, 50.3% had improvement in LVDD. In the overall cohort, KCCQ-OS score improved by 21.9 points at 1 year. There was a statistically significant association between change in LVDD severity (improved, unchanged, and worsened) and ΔKCCQ-OS at 1 year (p = 0.007). Conclusions: Change in LVDD grade was associated with change in health status 1 year following TAVR.

3.
Struct Heart ; 7(6): 100202, 2023 Nov.
Article En | MEDLINE | ID: mdl-38046858

Background: The effectiveness of cerebral embolic protection devices (CEPD) in mitigating stroke after transcatheter aortic valve implantation (TAVI) remains uncertain, and therefore CEPD may be utilized differently across US hospitals. This study aims to characterize the hospital-level pattern of CEPD use during TAVI in the US and its association with outcomes. Methods: Patients treated with nontransapical TAVI in the 2019 Nationwide Readmissions Database were included. Hospitals were categorized as CEPD non-users and CEPD users. The following outcomes were compared: the composite of in-hospital stroke or transient ischemic attack (TIA), in-hospital ischemic stroke, death, and cost of hospitalization. Logistic regression models were used for risk adjustment of clinical outcomes. Results: Of 41,822 TAVI encounters, CEPD was used in 10.6% (n = 4422). Out of 392 hospitals, 65.8% were CEPD non-user hospitals and 34.2% were CEPD users. No difference was observed between CEPD non-users and CEPD users in the risk of in-hospital stroke or TIA (adjusted odds ratio (OR) = 0.99 [0.86-1.15]), ischemic stroke (adjusted OR = 1.00 [0.85-1.18]), or in-hospital death (adjusted OR = 0.86 [0.71-1.03]). The cost of hospitalization was lower in CEPD non-users. Conclusions: Two-thirds of hospitals in the US do not use CEPD for TAVI, and no significant difference was observed in neurologic outcomes among patients treated at CEPD non-user and CEPD user hospitals.

4.
JACC Cardiovasc Interv ; 16(21): 2631-2641, 2023 11 13.
Article En | MEDLINE | ID: mdl-37737793

BACKGROUND: Little is known about the outcomes of transcatheter aortic valve replacement (TAVR) in minimally symptomatic patients. OBJECTIVES: The authors aimed to evaluate the outcomes of patients with minimally symptomatic severe aortic stenosis treated with TAVR in the STS/ACC TVT registry. METHODS: Minimally symptomatic status was defined as a baseline Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) ≥75. Clinical and health status outcomes of TAVR in patients with severe aortic stenosis and normal left ventricular ejection fraction were compared between minimally symptomatic patients and those with moderate or severe symptoms. RESULTS: Among 231,285 patients who underwent TAVR between 2015 and 2021 (median age 80.0 years [IQR: 74.0-86.0 years], 47.5% female), 20.0% were minimally symptomatic before TAVR. Survival at 1 year was higher in minimally symptomatic patients vs those with moderate or severe symptoms (adjusted HR for death: 0.70 [95% CI: 0.66-0.75]). Mean KCCQ-OS increased by 2.7 points (95% CI: 2.6-2.9 points) at 30 days and 3.8 points (95% CI: 3.6-4.0 points) at 1 year in minimally symptomatic patients compared with increases of 32.2 points (95% CI: 32.0-32.3 points) at 30 days and 34.9 points (95% CI: 34.7-35.0 points) at 1 year in more symptomatic patients. Minimally symptomatic patients had higher odds of being alive and well at 1 year (OR: 1.19 [95% CI: 1.16-1.23]). CONCLUSIONS: Although minimally symptomatic patients treated with TAVR experience only small improvements in health status, their overall outcomes are favorable with a higher likelihood of survival with good health status at 1 year compared with more symptomatic patients.


Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Humans , Female , Aged, 80 and over , Male , Transcatheter Aortic Valve Replacement/adverse effects , Stroke Volume , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Treatment Outcome , Ventricular Function, Left , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Risk Factors , Severity of Illness Index
5.
Cureus ; 15(1): e33251, 2023 Jan.
Article En | MEDLINE | ID: mdl-36741599

Spontaneous coronary artery dissection (SCAD) should be considered in the differential diagnosis of patients with provisional Takotsubo cardiomyopathy (TTS). However, because of overlapping clinical features, SCAD with subtle angiographic findings and wall motion abnormality like TTS can be easily missed. Therefore, our case highlights the importance of further investigation for SCAD.

6.
Circ Cardiovasc Interv ; 15(12): e012195, 2022 12.
Article En | MEDLINE | ID: mdl-36538580

BACKGROUND: Rehospitalization is a common end point in clinical trials of structural heart interventions, but whether rehospitalization is clinically and prognostically relevant in these patients is uncertain. The aim of this study was to evaluate the risk of rehospitalization events after aortic valve replacement (AVR) and their association with mortality and health status. METHODS: The study population included patients who underwent transcatheter or surgical AVR in the PARTNER I' II' and III trials (Placement of Aortic Transcatheter Valves). Health status was assessed with the Kansas City Cardiomyopathy Questionnaire-overall summary score. The primary analysis focused on heart failure hospitalization within 1 year after AVR and its association with mortality, poor outcome (death, Kansas City Cardiomyopathy Questionnaire-overall summary score <60 or decrease by ≥10), and health status at 1 year using adjusted models. Secondary analyses examined the prognostic associations of rehospitalization due to a composite of heart failure, valve-related, or procedure-related causes. RESULTS: Among 3403 patients treated with AVR (2008 transcatheter AVR, 1395 surgical AVR), the 1-year incidence was 6.7% for heart failure hospitalization and 9.7% for rehospitalization due to a composite of heart failure, valve-related, or procedure-related causes. Heart failure hospitalization after AVR was associated with increased risk of 1-year mortality (hazard ratio, 3.97 [2.48 to 6.36]; P<0.001), poor outcome (OR, 2.76 [1.73 to 4.40]; P<0.001), and worse health status (Kansas City Cardiomyopathy Questionnaire-overall summary mean difference -9.8 points [-13.8 to -5.8]; P<0.001). Rehospitalization due to a composite of heart failure, valve-related, or procedure-related causes was similarly associated with increased 1-year mortality (hazard ratio, 4.64 [3.11 to 6.92]; P<0.001), poor outcome (OR, 2.06 [1.38 to 3.07]; P=0.0004), and worse health status (Kansas City Cardiomyopathy Questionnaire-overall summary mean difference -8.8 points [-11.8 to -5.7]; P<0.001). There was no effect modification by treatment type (transcatheter AVR versus surgical AVR) for these associations. CONCLUSIONS: Heart failure hospitalization and rehospitalization after AVR are associated with increased risk of mortality and worse 1-year health status. These findings confirm the clinical and prognostic relevance of rehospitalization end points for trials of AVR. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT00530894.


Aortic Valve Stenosis , Cardiomyopathies , Heart Failure , Heart Valve Prosthesis Implantation , Transcatheter Aortic Valve Replacement , Humans , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/complications , Cardiomyopathies/complications , Cardiomyopathies/surgery , Heart Failure/diagnosis , Heart Failure/therapy , Heart Failure/epidemiology , Heart Valve Prosthesis Implantation/adverse effects , Patient Readmission , Risk Factors , Severity of Illness Index , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
7.
Ann Cardiothorac Surg ; 10(5): 564-570, 2021 Sep.
Article En | MEDLINE | ID: mdl-34733685

Valve-in-valve transcatheter aortic valve replacement (VIV TAVR) is currently indicated for the treatment of failed surgical tissue valves in patients determined to be at high surgical risk for re-operative surgical valve replacement. VIV TAVR, however, often results in suboptimal expansion of the transcatheter heart valve (THV) and can result in patient-prosthesis mismatch (PPM), particularly in small surgical valves. Bioprosthetic valve fracture (BVF) and bioprosthetic valve remodeling (BVR) can facilitate VIV TAVR by optimally expanding the THV and reducing the residual transvalvular gradient by utilizing a high-pressure inflation with a non-compliant balloon to either fracture or stretch the surgical valve ring, respectively. This article, along with the supplemental video, will provide patient selection, procedural planning and technical insights for performing BVF and BVR.

8.
J Am Heart Assoc ; 10(21): e022910, 2021 11 02.
Article En | MEDLINE | ID: mdl-34713717

Background Hospitalization rates after transcatheter aortic valve replacement (TAVR) remain high, given the age and comorbidities of patients undergoing TAVR. To better understand the impact of TAVR on hospitalization, we sought to compare hospitalization rates before and after TAVR and to examine if underlying patient comorbidities are associated with a differential effect of TAVR on hospitalizations. Methods and Results We used the Nationwide Readmissions Database to identify patients who underwent TAVR. As Nationwide Readmissions Database data do not cross over calendar years, we limited our index admission to hospitalizations during April to September of each calendar year to allow 90 days of observation before and after TAVRs. We calculated the daily risk of all-cause hospitalization and used a mixed-effects logistic regression model to explore interactions between patient characteristics, TAVR, and hospitalization risk. Among 39 249 patients who underwent TAVR in 2014 to 2017 (median age, 82 years [interquartile range, 76-87 years]; 45.7% women), 32.0% had at least one hospitalization in the 90 days before TAVR compared with 23.2% in the 90 days post-TAVR (relative reduction, 27.5%; P<0.001). In the mixed-effects logistic regression model, TAVR was associated with decreased all-cause hospitalization rate after TAVR in all comorbidity subgroups. However, younger patients and those with heart failure and reduced ejection fraction appeared to have more robust reduction in hospitalizations. Conclusions Although patients who are treated with TAVR have high rates of rehospitalization, TAVR is associated with an overall reduction in all-cause hospitalizations regardless of underlying patient comorbidities.


Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Aged, 80 and over , Aortic Valve/surgery , Aortic Valve Stenosis/epidemiology , Aortic Valve Stenosis/surgery , Female , Hospitalization , Humans , Male , Patient Readmission , Risk Factors , Time Factors , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
9.
JACC Heart Fail ; 9(9): 684-692, 2021 09.
Article En | MEDLINE | ID: mdl-34391740

OBJECTIVES: This study sought to understand the extent to which health status and exercise capacity are independently associated with long-term outcomes in patients with heart failure (HF) and secondary mitral regurgitation (MR). BACKGROUND: Secondary MR in patients with HF leads to impaired health status (Kansas City Cardiomyopathy Questionnaire Overall Summary Score [KCCQ-OS]) and exercise capacity (6-minute walk distance [6MWD]), both of which improve after transcatheter mitral valve repair (TMVr). METHODS: The study used data from the COAPT trial (N = 604) to examine the association of baseline KCCQ-OS and 6MWD with 2-year mortality and HF hospitalization, adjusting for treatment arm and patient factors. We also examined the association of change in KCCQ-OS and 6MWD from baseline to 1 month with risk of outcomes from 1 month to 2 years. Interactions of KCCQ-OS and 6MWD with treatment assignment were explored. RESULTS: Mean baseline KCCQ-OS was 53 ± 23 points, and 6MWD was 240 ± 125 meters. In models including both measures, greater baseline 6MWD (but not KCCQ-OS) was associated with reduced 2-year mortality (HR per 125 meters: 0.75, 95% CI: 0.61-0.92). When stratified by treatment group, both baseline KCCQ-OS and 6MWD were independently associated with HF hospitalization in patients treated with medical therapy, whereas only KCCQ-OS was associated with HF hospitalization in patients treated with TMVr. In separate analyses, 1-month improvements in KCCQ-OS and 6MWD were each associated with lower subsequent risk of mortality and HF hospitalization, independent of treatment group. CONCLUSIONS: Among patients with HF and severe secondary MR, assessment of both health status and exercise capacity provide complementary prognostic information for patients with HF and severe secondary MR-both before and after TMVr. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial]; NCT01626079).


Heart Failure , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Functional Status , Health Status , Heart Failure/complications , Heart Failure/surgery , Humans , Mitral Valve Insufficiency/complications , Mitral Valve Insufficiency/surgery , Prognosis , Quality of Life , Treatment Outcome
10.
JACC Case Rep ; 3(4): 682-685, 2021 Apr.
Article En | MEDLINE | ID: mdl-34317603

A 48-year-old woman presented with heart failure and bioprosthetic pulmonary valve regurgitation 2 years after pulmonary valve replacement. Intracardiac echocardiography demonstrated uniform thickening of a single prosthetic valve leaflet suggesting leaflet thrombosis rather than bioprosthetic valve degeneration. After 3 months of anticoagulation, valve regurgitation and symptoms improved. (Level of Difficulty: Intermediate.).

11.
JACC Cardiovasc Interv ; 13(23): 2795-2803, 2020 12 14.
Article En | MEDLINE | ID: mdl-33303119

OBJECTIVES: The aim of this study was to examine the relationship between chronic obstructive pulmonary disease (COPD) and outcomes after transcatheter mitral valve repair (TMVr) for severe secondary mitral regurgitation. BACKGROUND: TMVr with the MitraClip improves clinical and health-status outcomes in patients with heart failure and severe (3+ to 4+) secondary mitral regurgitation. Whether these benefits are modified by COPD is unknown. METHODS: COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) was an open-label, multicenter, randomized trial of TMVr plus guideline-directed medical therapy (GDMT) versus GDMT alone. Patients on corticosteroids or continuous oxygen were excluded. Multivariable models were used to examine the associations of COPD with mortality, heart failure hospitalization (HFH), and health status and to test whether COPD modified the benefit of TMVr compared with GDMT. RESULTS: Among 614 patients, 143 (23.2%) had COPD. Among patients treated with TMVr, unadjusted analyses demonstrated increased 2-year mortality in those with COPD (hazard ratio [HR]: 2.08; 95% confidence interval [CI]: 1.33 to 3.26), but this association was attenuated after risk adjustment (adjusted HR: 1.48; 95% CI: 0.87 to 2.52). Although TMVr led to reduced 2-year mortality among patients without COPD (adjusted HR: 0.47; 95% CI: 0.33 to 0.67), for patients with COPD, 2-year all-cause mortality was similar after TMVr versus GDMT alone (adjusted HR: 0.94; 95% CI: 0.54 to 1.65; pint = 0.04), findings that reflect offsetting effects on cardiovascular and noncardiovascular mortality. In contrast, TMVr reduced HFH (adjusted HR: 0.48 [95% CI: 0.28 to 0.83] vs. 0.46 [95% CI: 0.34 to 0.63]; pint = 0.89) and improved both generic and disease-specific health status to a similar extent compared with GDMT alone in patients with and without COPD (pint >0.30 for all scales). CONCLUSIONS: In the COAPT trial, COPD was associated with attenuation of the survival benefit of TMVr versus GDMT compared with patients without COPD. However, the benefits of TMVr on both HFH and health status were similar regardless of COPD. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079).


Heart Failure , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Pulmonary Disease, Chronic Obstructive , Heart Failure/surgery , Humans , Mitral Valve Insufficiency/complications , Mitral Valve Insufficiency/surgery , Pulmonary Disease, Chronic Obstructive/complications , Treatment Outcome
14.
Circ Cardiovasc Interv ; 13(2): e008448, 2020 02.
Article En | MEDLINE | ID: mdl-32069112

BACKGROUND: The American College of Cardiology/American Heart Association Appropriate Use Criteria were designed to aid clinical decision-making, yet their association with health status outcomes after chronic total occlusion percutaneous coronary intervention (PCI) is unknown. METHODS: We analyzed 769 patients with baseline and 1-year health status data after chronic total occlusion PCI. Procedures were categorized as appropriate, may be appropriate, or rarely appropriate. Mean changes in patient-reported health status, assessed by the Seattle Angina Questionnaire (SAQ), were compared across appropriate use criteria categories from baseline to 1 year. Change in SAQ summary score was stratified as little to no benefit (≤10 points), intermediate (10-19 points), large (20-29 points), and very large (≥30 points). RESULTS: The appropriate use criteria indication was appropriate in 573 patients (74.5%), may be appropriate in 191 (24.8%), and rarely appropriate in 5 (0.7%). Patients in the appropriate group reported greater improvement in SAQ summary scores (27.3±21.3 points) at 1 year compared with the may be appropriate (22.5±20.9; P=0.01). A similar pattern was noted for SAQ angina frequency (mean change 24.0±27.2 versus 18.7±25.6; P=0.02). The appropriate group had the highest proportion of very large improvements in SAQ summary scores (44.5% versus 33.3%; P=0.01). CONCLUSIONS: Among patients undergoing chronic total occlusion PCI, the rate of rarely appropriate PCI was low. The rate of appropriate PCI was high and was associated with the greatest health status improvement at 1 year. A substantial proportion of patients in the may be appropriate group experienced meaningful health status benefits as well.


Cardiologists/standards , Coronary Occlusion/therapy , Guideline Adherence/standards , Health Status , Outcome and Process Assessment, Health Care/standards , Percutaneous Coronary Intervention/standards , Practice Guidelines as Topic/standards , Practice Patterns, Physicians'/standards , Aged , Chronic Disease , Clinical Decision-Making , Coronary Occlusion/diagnosis , Coronary Occlusion/physiopathology , Female , Health Status Indicators , Humans , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Registries , Surveys and Questionnaires , Time Factors , Treatment Outcome , United States
15.
J Am Heart Assoc ; 9(3): e012541, 2020 02 04.
Article En | MEDLINE | ID: mdl-31973609

Background Underuse of guideline-recommended therapy in peripheral artery disease (PAD) in administrative and procedural databases has been described, but reports on medically managed patients and referral to supervised exercise therapy (SET) in PAD are lacking. We aimed to document the use of PAD guideline-recommended therapy, including SET in patients with PAD symptoms consulting a specialty clinic across 3 countries. Methods and Results The 16-center PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry enrolled 1275 patients with new or an exacerbation of PAD symptoms (2011-2015). We prospectively documented antiplatelet medications, statins, smoking cessation counseling and/or therapy, and referral to SET: "2 quality measures" referred to the use of both statin and antiplatelet medications; "4 quality measures" to receiving all 4 measures. Median odds ratios were calculated to quantify treatment variation across sites. A total of 89% patients were on antiplatelets, 83% on statins, and 23% had been referred to SET. Of 455 current smokers, 342 (72%) patients received smoking cessation therapy/counseling. Overall, 77.2% of patients received "2 quality measures" and 19.7% "4 quality measures." The median odds ratio for 2 quality measures was 2.13 (95% CI, 1.61-3.56; P<0.001) and for 4 quality measures was 5.43 (95% CI, 2.84-17.91; P<0.001). Variability in adherence was not explained by country, except for referral to SET. The odds for SET referral in The Netherlands (70% referral rate) was nearly 100 times greater than in US sites (2% referral rate). Conclusions Not all patients who have undergone a PAD workup at a specialty care facility are treated with evidence-based care, especially so for SET.


Ambulatory Care Facilities/standards , Cardiovascular Agents/therapeutic use , Exercise Therapy/standards , Guideline Adherence/standards , Peripheral Arterial Disease/therapy , Practice Guidelines as Topic/standards , Practice Patterns, Physicians'/standards , Referral and Consultation/standards , Aged , Australia , Female , Healthcare Disparities/standards , Humans , Male , Middle Aged , Netherlands , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/physiopathology , Prospective Studies , Quality Indicators, Health Care/standards , Registries , United States
17.
J Am Coll Cardiol ; 74(24): 2955-2965, 2019 12 17.
Article En | MEDLINE | ID: mdl-31568867

BACKGROUND: Transcatheter mitral valve repair (TMVr) for the treatment of mitral regurgitation (MR) is a complex procedure that requires development of a unique skillset. OBJECTIVES: The purpose of this study was to examine the relationship between operator experience and procedural results of TMVr. METHODS: TMVr device procedures from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry were analyzed with operator case number as a continuous and categorical (1 to 25, 26 to 50, and >50) variable. Outcomes of procedural success, procedural time, and in-hospital procedural complications were examined. The learning curve for the procedure was evaluated using generalized linear mixed models adjusting for baseline clinical variables. RESULTS: All TMVr device procedures (n = 14,923) performed by 562 operators at 290 sites between November 2013 and March 2018 were analyzed. Optimal procedural success (≤1+ residual MR without death or cardiac surgery) increased across categories of operator experience (63.9%, 68.4%, and 75.1%; p < 0.001), while procedural time and procedural complications decreased. Acceptable procedural success (≤2+ residual MR without death or cardiac surgery) also increased with operator experience, but the differences were smaller (91.4%, 92.4%, and 93.8%; p < 0.001). These associations remained significant in adjusted, continuous variable analyses. Visual inflection points in the learning curves for procedural time, procedural success, and procedural complications were evident after approximately 50 cases, with continued improvements observed out to 200 cases. CONCLUSIONS: For TMVr device procedures, operator experience was associated with improvements in procedural success, procedure time, and procedural complications. The effect of operator experience was greater when considering the goal of achieving 1+ residual MR.


Cardiac Surgical Procedures/statistics & numerical data , Endovascular Procedures/statistics & numerical data , Learning Curve , Mitral Valve/surgery , Registries , Aged , Aged, 80 and over , Cardiac Surgical Procedures/adverse effects , Cardiac Surgical Procedures/instrumentation , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Female , Humans , Male , Mitral Valve Insufficiency/surgery , Treatment Outcome , United States
18.
J Am Heart Assoc ; 8(16): e011766, 2019 08 20.
Article En | MEDLINE | ID: mdl-31423877

Background Smoking is a significant risk factor for aortic stenosis but its impact on clinical and health status outcomes after transcatheter aortic valve replacement (TAVR) has not been described. Methods and Results Patients (n=72 165) undergoing TAVR at 457 US sites in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between November 2011 and June 2016 were categorized at the time of TAVR as current/recent smokers versus prior/nonsmokers. A series of multivariable models examined the association between smoking status and outcomes, including 1-year mortality, rehospitalization, mean gradient, and health status (measured by the 12-item Kansas City Cardiomyopathy Questionnaire-Overall Summary Score [KCCQ-OS]) and in-hospital outcomes. A total of 4063 patients (5.6%) were smokers. Smokers presented for TAVR at a younger age (75 [68-81] years versus 83 [77-88] years) but with a greater burden of cardiovascular and lung disease. In adjusted models, smoking was associated with lower in-hospital mortality (relative risk, 0.74; 95% CI, 0.62-0.89 [P=0.001]) but not with in-hospital stroke/transient ischemic attack or myocardial infarction. Smoking status had no association with postdischarge mortality, stroke, myocardial infarction, or heart failure (HF) but was associated with slightly lower 1-year KCCQ-OS scores (2.4-point lower KCCQ-OS; 95% CI, -4.6 to -0.2 [P=0.031]) and higher mean aortic valve gradients (11.1 versus 10.2 mm Hg, P<0.001) in adjusted models. Conclusions The current/recent smoking rate in US patients with TAVR is 5.6% and smokers present at a younger age for TAVR. Smoking was associated with lower in-hospital but similar long-term survival after TAVR, slightly worse long-term health status, and marginally higher mean aortic valve gradients. Further research is needed to understand the effect of smoking cessation on outcomes.


Aortic Valve Stenosis/surgery , Cigarette Smoking/epidemiology , Mortality , Transcatheter Aortic Valve Replacement , Age Distribution , Aged , Aged, 80 and over , Aortic Valve Stenosis/epidemiology , Cardiovascular Diseases/epidemiology , Female , Health Status , Heart Failure/epidemiology , Hospital Mortality , Hospitalization/statistics & numerical data , Humans , Ischemic Attack, Transient/epidemiology , Lung Diseases/epidemiology , Male , Myocardial Infarction/epidemiology , Postoperative Complications/epidemiology , Prognosis , Proportional Hazards Models , Registries , Stroke/epidemiology , Treatment Outcome
19.
J Thorac Cardiovasc Surg ; 158(5): 1317-1328.e1, 2019 11.
Article En | MEDLINE | ID: mdl-30857820

OBJECTIVE: Valve-in-valve transcatheter aortic valve replacement (VIV TAVR) can result in high residual gradients that are associated with increased mortality. Bioprosthetic valve fracture (BVF) has been shown to improve residual gradients following VIV TAVR; however, factors influencing the results of BVF have not been studied. METHODS: BVF was performed in 75 patients at 21 centers. Hierarchical multiple linear regression was performed to identify variables that were associated with lower final transvalvular gradient. RESULTS: Surgical valves with a median true internal diameter of 18.5 mm (interquartile range, 17.0-20.5 mm) were treated with VIV TAVR in conjunction with BVF using balloon-expandable (n = 43) or self-expanding (n = 32) transcatheter heart valves with a median size of 23 mm (interquartile range, 23-23 mm). There were no aortic root disruptions, coronary occlusions, or new pacemakers; in-hospital or 30-day mortality was 2.6% (2 out of 75). Final mean transvalvular gradient was 9.2 ± 6.3 mm Hg, but was significantly lower when BVF was performed after VIV TAVR compared with BVF first (8.1 ± 4.8 mm Hg vs 16.9 ± 10.1 mm Hg; P < .001). After adjusting for timing of BVF (ie, before or after VIV TAVR), transcatheter heart valve size/type, surgical valve mode of failure, true internal diameter, and baseline gradient and BVF balloon size, performing BVF after VIV TAVR (P < .001) and using a larger BVF balloon (P = .038) were the only independent predictors of lower final mean gradient. CONCLUSIONS: BVF can be performed safely and results in reduced residual transvalvular gradients. Performing BVF after VIV TAVR and using larger balloon appears to achieve the best hemodynamic results.


Aortic Valve Stenosis , Aortic Valve/surgery , Balloon Valvuloplasty/methods , Bioprosthesis , Heart Valve Prosthesis , Reoperation , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Aortic Valve/diagnostic imaging , Aortic Valve/pathology , Aortic Valve Stenosis/epidemiology , Aortic Valve Stenosis/physiopathology , Aortic Valve Stenosis/surgery , Bioprosthesis/adverse effects , Bioprosthesis/statistics & numerical data , Female , Heart Valve Prosthesis/adverse effects , Heart Valve Prosthesis/statistics & numerical data , Hemodynamics , Humans , Male , Outcome and Process Assessment, Health Care , Prosthesis Design , Prosthesis Failure , Reoperation/instrumentation , Reoperation/methods , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/instrumentation , Transcatheter Aortic Valve Replacement/methods , United States
20.
Curr Cardiol Rep ; 20(10): 95, 2018 08 22.
Article En | MEDLINE | ID: mdl-30135999

PURPOSE OF REVIEW: This review aims to summarize data regarding bioprosthetic valve fracture (BVF), a novel technique that involves fracturing the surgical valve sewing ring to allow for further expansion of the transcatheter heart valve in patients undergoing valve in valve transcatheter aortic valve replacement (VIV TAVR). RECENT FINDINGS: Bench testing and clinical experience have demonstrated that most, but not all, bioprosthetic surgical valves can be fractured. BVF in patients with small- and intermediate-sized surgical valves results in a lower residual valve gradient and larger final valve effective orifice area as compared with standard VIV TAVR. However, whether patients with larger bioprothetic valves benefit from BVF, and whether the hemodynamic benefits of BVF translate into improved clinical outcomes, is unknown. BVF improves the hemodynamic results of VIV TAVR in small surgical valves. However, further research is needed to determine whether BVF is beneficial for patients with larger surgical valves, and whether the hemodynamic benefits of BVF result in improved clinical outcomes.


Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Bioprosthesis , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement/instrumentation , Aortic Valve/diagnostic imaging , Heart Valve Prosthesis Implantation/adverse effects , Hemodynamics , Humans , Prosthesis Design , Prosthesis Failure , Reoperation , Risk Factors , Time Factors , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
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