Minimum Core Data Elements for Transcatheter Mitral Therapies: Scientific Statement by PASSION CV, HVC, and TVTR.

Mitral regurgitation is the most common valvular disease and is estimated to affect over 5 million Americans. Real-world data collection contributes to safety and effectiveness evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, and clinical best practice research. We aimed to establish a minimum core data set in mitral interventions to promote efficient, reusable real-world data collection for all of these purposes. Two expert task forces separately evaluated and reconciled a list of candidate elements derived from: 1) 2 ongoing transcatheter mitral trials; and 2) a systemic literature review of high-impact mitral trials and U.S multicenter, multidevice registries. From 703 unique data elements considered, unanimous consensus agreement was achieved on 127 "core" data elements, with the most common reasons for exclusion from the minimum core data set being burden or difficulty in accurate assessment (41.2%), duplicative information (25.0%), and low likelihood of affecting outcomes (19.6%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established and implemented into the national Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapies Registry 127 interoperable, reusable core data elements to support more efficient, consistent, and informative transcatheter mitral device evidence for regulatory submissions, safety surveillance, best practice development, and hospital quality assessments.

Minimum Core Data Elements for Evaluation of TAVR: A Scientific Statement by PASSION CV, HVC, and TVT Registry.

Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 "core" data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments.

Minimum Core Data Elements for Evaluation of TAVR: A Scientific Statement by PASSION CV, HVC, and TVT Registry.

Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 "core" data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments.

Lessons for Treating Structural Heart Patients during the COVID-19 Pandemic and Beyond.

Background: We sought to compare characteristics and outcomes of structural heart disease (SHD) patients treated during the regional peak of the Coronavirus Disease 2019 (COVID-19) pandemic ("COVID era") compared with historical controls. During the COVID era, elective SHD procedures at Beth Israel Deaconess Medical Center were canceled but urgent cases were still performed. We enacted several practice changes in an effort to minimize complications, prevent COVID transmission, and decrease hospital stay during the pandemic. Methods: Baseline characteristics and outcomes were collected on all patients who underwent SHD procedures during the COVID era and compared with patients treated during the same time period in 2019. Results: Compared with SHD patients treated during 2019 (N = 259), those treated during the COVID era (N = 26) had higher left ventricular end diastolic pressure (LVEDP; 28 vs. 21 mmHg, p = 0.001), and were more likely New York Heart Association class IV (26.9% vs. 10.0%, p = 0.019), but had a lower rate of bleeding/vascular complications (0% vs. 16.2%, p = 0.013), a lower rate of permanent pacemaker implantation (0% vs. 17.4%, p = 0.019), and a greater proportion of patients were discharged on post-operative day 1 (POD#1; 68.2% vs. 22.2%, p < 0.001). Conclusion: Practice changes employed for patients treated during the COVID era were associated with fewer vascular complications, a greater proportion of patients discharged on POD#1, and a lower rate of pacemaker implantation despite more severe illness. As a result, we plan to continue these practices in the post-COVID era.

Best Practice Recommendations for Optimizing Care in Structural Heart Programs: Planning Efficient and Resource Leveraging Systems (PEARLS).

The COVID19 pandemic brought unprecedented disruption to healthcare. Staggering morbidity, mortality, and economic losses prompted the review and refinement of care for structural heart disease (SHD). To mitigate negative impacts in the face of crisis or capacity constraints, this paper offers best practice recommendations for Planning Efficient and Resource Leveraging Systems (PEARLS) in structural heart programs. A systematic assessment is recommended for hospital capacity, Heart Team roles and functions, and patient and procedural risks associated with increased resource utilization. Strategies, tactics, and pathways are provided for the delivery of patient-centered, efficient and resource-leveraging care from referral to follow-up. Through the optimal use of capacity and resources, paired with dynamic triage, forecasting, and surveillance, Heart Teams may aspire to plan and implement an optimized system of care for SHD. Abbreviations: AS: aortic stenosis; ASD: atrioseptal defect; COVID19: Coronavirus disease 19; LAAO: left atrial appendage occlusion; MI: myocardial infarction; MR: mitral regurgitation; PFO: patent foramen ovale; PVL: paravalvular leak; SHD: structural heart disease; SAVR: surgical aortic valve replacement; SDM: shared decision-making; TAVR: transcatheter aortic valve replacement; TMVr: transcatheter mitral valve repair; TMVR: transcatheter mitral valve replacement; TEE: transesophageal echocardiography; TTE: transthoracic echocardiography.

Physical Performance and Risk of Postoperative Delirium in Older Adults Undergoing Aortic Valve Replacement.

BACKGROUND: Delirium is a major risk factor for poor recovery after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). It is unclear whether preoperative physical performance tests improve delirium prediction. OBJECTIVE: To examine whether physical performance tests can predict delirium after SAVR and TAVR, and adapt an existing delirium prediction rule for cardiac surgery, which includes Mini-Mental State Examination (MMSE), depression, prior stroke, and albumin level. DESIGN: Prospective cohort, 2014-2017. SETTING: Single academic center. SUBJECTS: A total of 187 patients undergoing SAVR (n=77) or TAVR (n=110). METHODS: The Short Physical Performance Battery (SPPB) score was calculated based on gait speed, balance, and chair stands (range: 0-12 points, lower scores indicate poor performance). Delirium was assessed using the Confusion Assessment Method. We fitted logistic regression to predict delirium using SPPB components and risk factors of delirium. RESULTS: Delirium occurred in 35.8% (50.7% in SAVR and 25.5% in TAVR). The risk of delirium increased for lower SPPB scores: 10-12 (28.2%), 7-9 (34.5%), 4-6 (37.5%) and 0-3 (44.1%) (p-for-trend=0.001). A model that included gait speed <0.46 meter/second (OR, 2.7; 95% CI, 1.2-6.4), chair stands time ≥11.2 seconds (OR, 3.5; 95% CI, 1.0-12.4), MMSE <24 points (OR, 2.9; 95% CI, 1.3-6.4), isolated SAVR (OR, 5.4; 95% CI, 2.1-13.8), and SAVR and coronary artery bypass grafting (OR, 15.8; 95% CI, 5.5-45.7) predicted delirium better than the existing prediction rule (C statistics: 0.71 vs 0.61; p=0.035). CONCLUSION: Assessing physical performance, in addition to cognitive function, can help identify high-risk patients for delirium after SAVR and TAVR.

Cognition, Frailty, and Functional Outcomes of Transcatheter Aortic Valve Replacement.

BACKGROUND: Cognitive impairment and frailty are highly prevalent in older adults undergoing transcatheter aortic valve replacement. This study aimed to investigate the relationship of cognitive impairment and frailty with functional recovery after transcatheter aortic valve replacement. METHODS: This was a single-center prospective cohort study of 142 patients who were ≥70 years old and underwent transcatheter aortic valve replacement for aortic stenosis. Prior to transcatheter aortic valve replacement, cognitive impairment was defined as Mini-Mental State Examination score <24 points (range: 0-30), and moderate-to-severe frailty was defined as a deficit-accumulation frailty index ≥0.35 (range: 0-1). The functional status composite score, the number of 22 daily and physical tasks that a patient could perform independently, measured at baseline and 1, 3, 6, 9, and 12 months postoperatively were analyzed using linear mixed-effects model. RESULTS: The mean age was 84.2 years; 74 subjects were women (51.8%). Patients with moderate-to-severe frailty and cognitive impairment (n = 27, 19.0%) had the lowest functional status at baseline and throughout 12 months, while patients with mild or no frailty and no cognitive impairment (n = 48, 33.8%) had the best functional status. Patients with cognitive impairment alone (n = 19, 13.4%) had better functional status at baseline than those with moderate-to-severe frailty alone (n = 48, 33.8%), but their functional status scores merged and remained similar during the follow-up. CONCLUSIONS: Preoperative cognitive function plays a vital role in functional recovery after transcatheter aortic valve replacement, regardless of baseline frailty status. Impaired cognition may increase functional decline in the absence of frailty, whereas intact cognition may mitigate the detrimental effects of frailty. Cognitive assessment should be routinely performed prior to transcatheter aortic valve replacement.

Comparative utility of frailty to a general prognostic score in identifying patients at risk for poor outcomes after aortic valve replacement.

BACKGROUND: Current guidelines recommend considering life expectancy before aortic valve replacement (AVR). We compared the performance of a general mortality index, the Lee index, to a frailty index. METHODS: We conducted a prospective cohort study of 246 older adults undergoing surgical (SAVR) or transcatheter aortic valve replacement (TAVR) at a single academic medical center. We compared performance of the Lee index to a deficit accumulation frailty index (FI). Logistic regression was used to assess the association of Lee index or FI with poor outcome, defined as death or functional decline with severe symptoms at 12 months. Discrimination was assessed using C-statistics. RESULTS: In the overall cohort, 44 experienced poor outcome (31 deaths, 13 functional decline with severe symptoms). The risk of poor outcome by Lee index quartiles was 6.8% (reference), 17.9% (odds ratio [OR], 3.0; 95% confidence interval, [0.9-10.2]), 20.0% (OR 3.4; [1.0-11.4]), and 34.0% (OR 7.1; [2.2-22.6]) (p-for-trend = 0.001). Risk of poor outcome by FI quartiles was 3.6% (reference), 10.3% (OR 3.1; [0.6-15.8]), 25.0% (OR 8.8; [1.9-41.0]), and 37.3% (OR 15.8; [3.5-71.1]) (p-for-trend< 0.001). The Lee index predicted the risk of poor outcome in the SAVR cohort Lee index (quartiles 1-4: 2.1, 4.0, 15.4, and 20.0%; p-for-trend = 0.04), but not in the TAVR cohort (quartiles 1-4: 27.3, 29.0, 21.3, 35.4%; p-for-trend = 0.42). In contrast, the FI did not predict the risk of poor outcome well in the SAVR cohort (quartiles 1-4: 2.3, 4.4, 15.8, and 0%; p-for-trend = 0.24), however in the TAVR cohort (quartiles 1-4: 9.1, 14.3, 29.7, and 40.7%; p-for-trend = 0.004). Compared to the Lee index, an FI demonstrated higher C-statistics in the overall (Lee index versus FI: 0.680 versus 0.735; p = 0.03) and TAVR (0.560 versus 0.644; p = 0.03) cohorts, but not SAVR cohort (0.724 versus 0.766; p = 0.09). CONCLUSIONS: While a general mortality index Lee index predicted death or functional decline with severe symptoms at 12 months well among SAVR patients, the FI derived from a multi-domain geriatric assessment better informs risk-stratification for high-risk TAVR patients.

The Impact of Basal Septal Hypertrophy on Outcomes after Transcatheter Aortic Valve Replacement.

BACKGROUND: The role of basal septal hypertrophy (BSH) on preprocedural transthoracic echocardiography in transcatheter aortic valve replacement (TAVR) is unknown. METHODS: Medical charts and preprocedural transthoracic echocardiograms of 378 patients who underwent TAVR were examined. The association between BSH and the primary composite outcome of valve pop-out, recapture, embolization, aborted procedure, conversion to open procedure, new conduction disturbance, or need for permanent pacemaker ≤30 days after TAVR was evaluated. Patients with preexisting pacemakers were excluded. Sensitivity analyses were performed varying the definition of BSH. RESULTS: Of 296 TAVR patients (78.3%) with interpretable images, 55 (18.6%) had BSH at a median of 40 days (interquartile range, 19-62 days) before TAVR. Age and sex were similar among those with and without BSH. BSH patients received postdilation more frequently (BSH+ vs BSH-: 41.8% vs 29.9%, P = .04). A total of 50 individuals (16.9%) received pacemakers within 30 days, and 128 (43.2%) developed conduction disturbances (with left bundle branch block most common), without differences between groups. BSH was unrelated to the primary outcome on multivariate analysis (adjusted odds ratio BSH+ vs BSH-, 0.94; 95% CI, 0.42-2.11; P = .88). CONCLUSIONS: In this convenience sample of TAVR recipients at a large academic medical center, patients with BSH were more likely to receive postdilation. BSH was not associated with procedural or conduction outcomes after TAVR in patients without preexisting pacemakers.

A Practical Two-Stage Frailty Assessment for Older Adults Undergoing Aortic Valve Replacement.

OBJECTIVES: Despite evidence, frailty is not routinely assessed before cardiac surgery. We compared five brief frailty tests for predicting poor outcomes after aortic valve replacement and evaluated a strategy of performing comprehensive geriatric assessment (CGA) in screen-positive patients. DESIGN: Prospective cohort study. SETTING: A single academic center. PARTICIPANTS: Patients undergoing surgical aortic valve replacement (SAVR) (n = 91; mean age = 77.8 y) or transcatheter aortic valve replacement (TAVR) (n = 137; mean age = 84.5 y) from February 2014 to June 2017. MEASUREMENTS: Brief frailty tests (Fatigue, Resistance, Ambulation, Illness, and Loss of weight [FRAIL] scale; Clinical Frailty Scale; grip strength; gait speed; and chair rise) and a deficit-accumulation frailty index based on CGA (CGA-FI) were measured at baseline. A composite of death or functional decline and severe symptoms at 6 months was assessed. RESULTS: The outcome occurred in 8.8% (n = 8) after SAVR and 24.8% (n = 34) after TAVR. The chair rise test showed the highest discrimination in the SAVR (C statistic = .76) and TAVR cohorts (C statistic = .63). When the chair rise test was chosen as a screening test (≥17 s for SAVR and ≥23 s for TAVR), the incidence of outcome for screen-negative patients, screen-positive patients with CGA-FI of .34 or lower, and screen-positive patients with CGA-FI higher than .34 were 1.9% (n = 1/54), 5.3% (n = 1/19), and 33.3% (n = 6/18) after SAVR, respectively, and 15.0% (n = 9/60), 14.3% (n = 3/21), and 38.3% (n = 22/56) after TAVR, respectively. Compared with routinely performing CGA, targeting CGA to screen-positive patients would result in 54 fewer CGAs, without compromising sensitivity (routine vs targeted: .75 vs .75; P = 1.00) and specificity (.84 vs .86; P = 1.00) in the SAVR cohort; and 60 fewer CGAs with lower sensitivity (.82 vs.65; P = .03) and higher specificity (.50 vs .67; P < .01) in the TAVR cohort. CONCLUSIONS: The chair rise test with targeted CGA may be a practical strategy to identify older patients at high risk for mortality and poor recovery after SAVR and TAVR in whom individualized care management should be considered. J Am Geriatr Soc 67:2031-2037, 2019.

Delirium Incidence and Functional Outcomes After Transcatheter and Surgical Aortic Valve Replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) may be associated with less delirium and allow faster recovery than surgical aortic valve replacement (SAVR). OBJECTIVE: To examine the association of delirium and its severity with clinical and functional outcomes after SAVR and TAVR. DESIGN: Prospective cohort study. SETTING: An academic medical center. PARTICIPANTS: A total of 187 patients, aged 70 years and older, undergoing SAVR (N = 77) and TAVR (N = 110) in 2014 to 2016. MEASUREMENTS: Delirium was assessed daily using the Confusion Assessment Method (CAM), with severity measured by the CAM-Severity (CAM-S) score (range = 0-19). Outcomes were prolonged hospitalization (9 days or more); institutional discharge; and functional status, measured by ability to perform 22 daily activities and physical tasks over 12 months. RESULTS: SAVR patients had a higher incidence of delirium than TAVR patients (50.7% vs 25.5%; P < .001), despite younger mean age (77.9 vs 83.7 years) and higher baseline Mini-Mental State Examination score (26.9 vs 24.7). SAVR patients with delirium had a shorter duration (2.2 vs 3.4 days; P = .04) with a lower mean CAM-S score (4.5 vs 5.7; P = .01) than TAVR patients with delirium. The risk of prolonged hospitalization in no, mild, and severe delirium was 18.4%, 30.8%, and 61.5% after SAVR (P for trend = .009) and 26.8%, 38.5%, and 73.3% after TAVR (P for trend = .001), respectively. The risk of institutional discharge was 42.1%, 58.3%, and 84.6% after SAVR (P for trend = .01) and 32.5%, 69.2%, and 80.0% after TAVR (P for trend <.001), respectively. Severe delirium was associated with delayed functional recovery after SAVR and persistent functional impairment after TAVR at 12 months. CONCLUSION: Less invasive TAVR was associated with lower incidence of delirium than SAVR. Once delirium developed, TAVR patients had more severe delirium and worse functional status trajectory than SAVR patients did. REGISTRATION: NCT01845207.

Evaluation of Changes in Functional Status in the Year After Aortic Valve Replacement.

Importance: Functional status is a patient-centered outcome that is important for a meaningful gain in health-related quality of life after aortic valve replacement. Objective: To determine functional status trajectories in the year after transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). Design, Setting, and Participants: A prospective cohort study with a 12-month follow-up was conducted at a single academic center in 246 patients undergoing TAVR or SAVR for severe aortic stenosis. The study was conducted between February 1, 2014, and June 30, 2017; data analysis was performed from December 27, 2017, to May 7, 2018. Exposures: Preoperative comprehensive geriatric assessment was performed and a deficit-accumulation frailty index (CGA-FI) (range, 0-1; higher values indicate greater frailty) was calculated. Main Outcomes and Measures: Telephone interviews were conducted to assess self-reported ability to perform 22 activities and physical tasks at 1, 3, 6, 9, and 12 months after the procedure. Results: Of the 246 patients included in the study, 143 underwent TAVR (74 [51.7%] women; mean [SD] age, 84.2 [5.9] years), and 103 underwent SAVR (46 [44.7%] women; age, 78.1 [5.3] years). Five trajectories were identified based on functional status at baseline and during the follow-up: from excellent at baseline to improvement at follow-up (excellent baseline-improvement), good (high baseline-full recovery), fair (moderate baseline-minimal decline), poor (low baseline-moderate decline), and very poor (low baseline-large decline). After TAVR, the most common trajectory was fair (54 [37.8%]), followed by good (33 [23.1%]), poor (21 [14.7%]), excellent (20 [14.0%]), and very poor (12 [8.4%]) trajectories. After SAVR, the most common trajectory was good (39 [37.9%]), followed by excellent (38 [36.9%]), fair (20 [19.4%]), poor (3 [2.9%]), and very poor (1 [1.0%]) trajectories. Preoperative frailty level was associated with lower probability of functional improvement and greater probability of functional decline. After TAVR, patients with CGA-FI level of 0.20 or lower had excellent (3 [50.0%]) or good (3 [50.0%]) trajectories, whereas most patients with CGA-FI level of 0.51 or higher had poor (10 [45.5%]) or very poor (5 [22.7%]) trajectories. After SAVR, most patients with CGA-FI level of 0.20 or lower had excellent (24 [58.5%]) or good (15 [36.6%]) trajectories compared with a fair trajectory (5 [71.4%]) in those with CGA-FI levels of 0.41 to 0.50. Postoperative delirium and major complications were associated with functional decline after TAVR (delirium present vs absent: 14 [50.0%] vs 11 [13.4%]; complications present vs absent: 14 [51.9%] vs 19 [16.4%]) or lack of improvement after SAVR (delirium present vs absent: 27 [69.2%] vs 31 [81.6%]; complications present vs absent: 10 [62.5%] vs 69 [79.3%]). Conclusions and Relevance: The findings suggest that functional decline or lack of improvement is common in older adults with severe frailty undergoing TAVR or SAVR. Although this nonrandomized study does not allow comparison of the effectiveness between TAVR and SAVR, anticipated functional trajectories may inform patient-centered decision making and perioperative care to optimize functional outcomes.