Five-Year Follow-Up from the CoreValve Expanded Use Transcatheter Aortic Valve-in-Surgical Aortic Valve Study.

Transcatheter aortic valve replacement (TAVR) provides an option for extreme-risk patients who underwent reoperation for a failed surgical aortic bioprosthesis. Long-term data on patients who underwent TAVR within a failed surgical aortic valve (TAV-in-SAV) are limited. The CoreValve Expanded Use Study evaluated patients at extreme surgical risk who underwent TAV-in-SAV. Outcomes at 5 years were analyzed by SAV failure mode (stenosis, regurgitation, or combined). Echocardiographic outcomes are site-reported. TAV-in-SAV was attempted in 226 patients with a mean age of 76.7 ± 10.8 years; 63.3% were male, the Society of Thoracic Surgeons predicted risk of mortality score was 9.0 ± 6.7%, and 87.5% had a New York Heart Association classification III or IV symptoms. Most of the failed surgical bioprostheses were stented (81.9%), with an average implant duration of 10.2 ± 4.3 years. The 5-year all-cause mortality or major stroke rate was 47.2% in all patients; 54.4% in the stenosis, 37.6% in the regurgitation, and 38.0% in the combined groups (p = 0.046). At 5 years, all-cause mortality was higher in patients with versus without 30-day severe prosthesis-patient mismatch (51.7% vs 38.3%, p = 0.026). The overall aortic valve reintervention rate was 5.9%; highest in the regurgitation group (12.6%). The mean aortic valve gradient was 14.1 ± 9.8 mm Hg and effective orifice area was 1.57 ± 0.70 at 5 years. Few patients had >mild paravalvular regurgitation at 5 years (5.5% moderate, 0.0% severe). TAV-in-SAV with supra-annular, self-expanding TAVR continues to represent a safe and lasting intermediate option for extreme-risk patients who have appropriate sizing of the preexisting failed surgical valve. Clinical and hemodynamic outcomes were stable through 5 years.

Echocardiographic and Clinical Outcomes in Symptomatic Patients With Less Than Severe Aortic Stenosis After Supra-Annular Self-Expanding Transcatheter Aortic Valve Replacement.

Optimal timing for aortic valve replacement in symptomatic patients with less than severe aortic stenosis (AS) is not well defined. There is limited information on the benefit of valve replacement in these patients. Symptomatic patients with less than severe AS, defined as a mean aortic gradient ≥20 and <40 mm Hg, peak aortic velocity >3 and <4 m/s, and aortic valve area >1.0 and <1.5 cm2, enrolled in the Society for Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy Registry and who underwent attempted supra-annular, self-expanding transcatheter aortic valve replacement (TAVR) were reviewed. Site-reported valve hemodynamics, clinical events, and quality of life metrics were analyzed at 30 days and 1 year after the procedure. A total of 1,067 patients with attempted TAVR (mean age 78.4 ± 8.4 years; Society for Thoracic Surgery score 4.7 ± 3.4%) were found to have symptoms but less than severe AS. From baseline to postprocedure, mean gradient decreased (29.9 ± 4.9 vs 8.4 ± 4.8 mm Hg, p <0.001), and aortic valve area increased (1.2 ± 0.1 vs 2.2 ± 0.7 cm2, p <0.001). Clinical events included 30-day and 1-year all-cause mortality (1.5% and 9.6%), stroke (2.2% and 3.3%), and new pacemaker implantation (18.1% and 20.9%). There were statistically significant improvements in the New York Heart Association functional class and Kansas City Cardiomyopathy Questionnaire at 30 days and 1 year. In conclusion, patients with symptomatic but less than severe AS who underwent supra-annular, self-expanding TAVR experienced improved valve hemodynamics and quality of life measures 1 year after the procedure. Randomized studies of TAVR versus a control arm in symptomatic patients with less than severe AS are ongoing.

Comprehensive Training Model for Procedural Guidance of Transcatheter Mitral Valve Edge-to-Edge Repair: Divide and Conquer Approach.

Transcatheter edge-to-edge repair (TEER) of the mitral valve is a complex procedure requiring continuous image guidance with 2-dimensional and 3-dimensional transesophageal echocardiography. In this context, the role of the echocardiographer is of paramount importance. Training in interventional echocardiography for procedures such as TEER requires comprehending the complicated workflow of the hybrid operating room and advanced imaging skills that go beyond traditional echocardiography training to guide the procedure. Despite TEER being more commonly performed, the training structure for interventional echocardiographers is lagging, with many practitioners not having any formal training in image guidance for this procedure. In this context, novel training strategies must be developed to increase exposure and aid training. In this review, the authors present a step-wise approach to training for image guidance during TEER of the mitral valve. The authors have deconstructed this complex procedure into modular components and have incremental stages of training based on different steps of the procedure. At each step, trainees must demonstrate proficiency before advancing to the next step, thus ensuring a more structured approach to attaining proficiency in this complex procedure.

Site-Level Variation and Predictors of Permanent Pacemaker Implantation Following TAVR in the Evolut Low-Risk Trial.

We evaluated predictors of permanent pacemaker implantation (PPI) following self-expanding transcatheter aortic valve replacement (TAVR), examined site-to-site variability of PPI rates, and explored the relationship of implantation methods on the need for PPI. Despite the benefits of TAVR compared to surgical aortic valve replacement, increased PPI remains a limitation. A total of 699 patients without baseline PPI were included in the study. Clinical, echocardiographic, and procedural characteristics were compared in patient with and without new PPI. Clinical outcomes were assessed at 30 days and 1 year. Funnel plots were constructed to display site-to- site variability and identify outliers in PPI. Clinical outcomes were similar in patients with and without PPI. Predictors of a new PPI within 7 days included a baseline right bundle branch block (p < 0.001) and not using general anesthesia (p = 0.003). There was substantial site to site variability in the rate of PPI. Patients at sites with a lower PPI rate had shallower implantation depth at the non-coronary (p < 0.001) and the left coronary sinus (p < 0.001), and fewer patients with an implantation depth > 5 mm below the annulus (p = 0.004). In low-risk patients undergoing TAVR with Evolut valves, baseline conduction disorders and implant depth were important predictors of PPI. Implantation method may have contributed to this variability in PPI rates across clinical sites.

Functional Status After Transcatheter and Surgical Aortic Valve Replacement: 2-Year Analysis From the SURTAVI Trial.

OBJECTIVES: This study sought to evaluate patient-centered metrics in intermediate-surgical-risk aortic stenosis patients enrolled in the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial treated with self-expanding transcatheter aortic valve replacement (TAVR) or surgery. BACKGROUND: Studies have shown TAVR to be an alternative to surgery in patients with severe symptomatic aortic stenosis but have focused on "hard endpoints," including all-cause mortality and stroke, rather than on comparative patient-centered metrics, such as functional status and symptom burden. METHODS: The study analyzed functional status (6-minute walk test [6MWT]) and symptom burden (Kansas City Cardiomyopathy Questionnaire) in 1,492 patients from the SURTAVI trial at baseline, 30 days, 1 year, and 2 years. Patients were categorized by baseline functional status into tertiles of slow, medium, and fast walkers. RESULTS: Patients with lowest capacity baseline functional status were commonly women, had higher Society of Thoracic Surgeons scores, and had more New York Heart Association functional class III or IV symptoms; reduced baseline functional status was associated with higher aortic valve- and heart failure-related hospitalization at 2 years. There was greater improvement in 6MWT distance in TAVR compared with surgery patients at 30 days (P < 0.001) and 1 year (P = 0.012), but at 2 years, both groups had similar improvement (P = 0.091). The percentage of patients with large improvement in 6MWT was greatest in patients categorized as slow walkers and lowest in fast walkers. Symptom burden improved after TAVR at 30 days and after both procedures at 1 and 2 years. CONCLUSIONS: In this substudy of patients from the SURTAVI trial, patients receiving TAVR demonstrated a more rapid improvement in functional status and symptom burden compared with patients undergoing surgery; however, both groups had similar improvements in long-term follow-up. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910).

Meta-Analysis Comparing Valve Durability Among Different Transcatheter and Surgical Aortic Valve Bioprosthesis.

Durability of transcatheter heart valve (THV) is critical as the indication of transcatheter aortic valve implantation (TAVI) expands to patients with longer life-expectancy. We aimed to compare the durability of different THV systems (balloon-expandable [BE] and self-expandable [SE]) and surgical aortic valve replacement (SAVR) prosthesis. PUBMED and EMBASE were searched through February 2021 for randomized trials investigating parameters of valve durability after TAVI and/or SAVR in severe aortic stenosis. A network meta-analysis using random-effect model was performed. Synthesis was performed with 5-year follow-up data for echocardiographic outcomes and the longest available follow-up data for clinical outcomes. Ten trials with a total of 9,388 patients (BE-THV: 2,562; SE-THV: 2,863; SAVR: 3,963) were included. Follow-up ranged from 1 to 6 years. SE-THV demonstrated significantly larger effective orifice area, lower mean aortic valve gradient (AVG), and less increase in mean AVG at 5-year compared with BE-THV and SAVR. Structural valve deterioration (SVD) was less frequent in SE-THV compared with BE-THV and SAVR (HR 0.14, 95% CI 0.07 to 0.27; HR 0.34, 95% CI 0.24 to 0.47, respectively). Total moderate-severe aortic regurgitation and reintervention was more frequent in BE-THV (HR 4.21, 95% CI 2.40 to 7.39; HR 2.22, 95% CI 1.16 to 4.26, respectively), and SE-THV (HR 7.51, 95% CI 3.89 to 14.5; HR 2.86, 95% CI 1.59 to 5.13, respectively) compared with SAVR. In conclusion, TAVI with SE-THV demonstrated favorable forward-flow hemodynamics and lowest risk of SVD compared with BE-THV and SAVR at mid-term. However, both THV systems suffer an increased risk of AR and re-intervention, and long-term data from newer generation valves is warranted.

Preventing Coronary Obstruction During Transcatheter Aortic Valve Replacement: Results From the Multicenter International BASILICA Registry.

OBJECTIVES: This study sought to determine the safety of the BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) procedure. BACKGROUND: Transcatheter aortic valve replacement causes coronary artery obstruction in 0.7% of cases, with 40% to 50% mortality. BASILICA is a procedure to prevent coronary obstruction. Safety and feasibility in a large patient cohort is lacking. METHODS: The international BASILICA registry was a retrospective, multicenter, real-world registry of patients at risk of coronary artery obstruction undergoing BASILICA and transcatheter aortic valve replacement. Valve Academic Research Consortium-2 definitions were used to adjudicate events. RESULTS: Between June 2017 and December 2020, 214 patients were included from 25 centers in North America and Europe; 72.8% had bioprosthetic aortic valves and 78.5% underwent solo BASILICA. Leaflet traversal was successful in 94.9% and leaflet laceration in 94.4%. Partial or complete coronary artery obstruction was seen in 4.7%. Procedure success, defined as successful BASILICA traversal and laceration without mortality, coronary obstruction, or emergency intervention, was achieved in 86.9%. Thirty-day mortality was 2.8% and stroke was 2.8%, with 0.5% disabling stroke. Thirty-day death and disabling stroke were seen in 3.4%. Valve Academic Research Consortium-2 composite safety was achieved in 82.8%. One-year survival was 83.9%. Outcomes were similar between solo and doppio BASILICA, between native and bioprosthetic valves, and with the use of cerebral embolic protection. CONCLUSIONS: BASILICA is safe, with low reported rates of stroke and death. BASILICA is feasible in the real-world setting, with a high procedure success rate and low rates of coronary artery obstruction.

CoreValve bioprosthesis dysfunction treated with a Sapien 3 valve-in-valve transcatheter aortic valve replacement and BASILICA technique.

Structural deterioration of transcatheter heart valve (THV) has been previously described. With the expansion of transcatheter aortic valve replacement (TAVR) indications toward treating lower risk patients with longer life expectancy, there will be increased necessity of managing the patients with THV dysfunction including those at risk for coronary obstruction or sinus sequestration. Coronary access also remains a challenge in such cases with THV dysfunction undergoing valve-in-transcatheter heart valve (ViTHV) TAVR. A unique and first reported case of THV deterioration treated with Sapien 3 ViTHV-TAVR inside a 31 mm CoreValve bioprosthesis along with left coronary leaflet laceration using the BASILICA technique has been presented.

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.

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.

Percutaneous Management of a Contained Annular Rupture Occurring With Self-Expanding Transcatheter Aortic Valve Replacement.

Annular rupture is a rare catastrophic event during transcatheter aortic valve replacement, often life threatening and requiring emergent surgical repair. We describe, herein, a case of contained annular rupture successfully managed percutaneously with coiling and polymer injection. This is a novel technique to manage this complication. (Level of Difficulty: Advanced.).

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.

Frailty Phenotype and Deficit Accumulation Frailty Index in Predicting Recovery After Transcatheter and Surgical Aortic Valve Replacement.

BACKGROUND: Frailty phenotype and deficit-accumulation frailty index (FI) are widely used measures of frailty. Their performance in predicting recovery after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) has not been compared. METHODS: Patients undergoing SAVR (n = 91) or TAVR (n = 137) at an academic medical center were prospectively assessed for frailty phenotype and FI. Outcomes were death or poor recovery, defined as a decline in ability to perform 22 daily activities and New York Heart Association class 3 or 4 at 6 months after surgery. The predictive ability of frailty phenotype versus FI and their additive value to a traditional surgical risk model were evaluated using C-statistics, net reclassification improvement (NRI), and integrated discrimination improvement. RESULTS: TAVR patients had higher prevalence of phenotypic frailty (85% vs 38%, p < .001) and greater mean FI (0.37 vs 0.24, p < .001) than SAVR patients. In the overall cohort, FI had a higher C-statistic than frailty phenotype (0.74 vs 0.63, p = .01) for predicting death or poor recovery. Adding FI to the traditional model improved prediction (NRI, 26.4%, p = .02; integrated discrimination improvement, 7.7%, p < .001), while adding phenotypic frailty did not (NRI, 4.0%, p = .70; integrated discrimination improvement, 1.6%, p = .08). The additive value of FI was evident in TAVR patients (NRI, 42.8%, p < .01) but not in SAVR patients (NRI, 25.0%, p = .29). Phenotypic frailty did not add significantly in either TAVR (NRI, 6.8%, p = .26) or SAVR patients (NRI, 25.0%, p = .29). CONCLUSIONS: Deficit-accumulation FI provides better prediction of death or poor recovery than frailty phenotype in older patients undergoing SAVR and TAVR.

Prevalence and Outcomes of Isolated Tricuspid Valve Surgery Among Medicare Beneficiaries.

We sought to characterize the clinical outcomes and to identify predictors of mortality undergoing isolated tricuspid valve surgery in the United States. We identified 5,164 patients undergoing isolated tricuspid valve surgery from the Centers for Medicare and Medicaid Services Medicare Provider Analysis and Review data between January 2003 and December 2014. The primary outcome was all cause 1-year mortality. A backward elimination method was performed to identify predictors of 1-year mortality. Tricuspid valve repair was performed in 2,494 (48.3%) patients and tricuspid valve replacement was performed in 2,670 (51.7%) patients. Perioperative and 1-year mortality rates were 9.9% and 24.1%, respectively. Predictors of 1-year mortality were age (p <0.001), chronic heart failure (p = 0.001, cirrhosis (p <0.001), carcinoid syndrome (p <0.001), chronic kidney disease (p = 0.001), secondary pulmonary hypertension (p = 0.023), endocarditis (p = 0.005), decubitus ulcer (p <0.001), malnutrition (p <0.001), replacement (p = 0.013), emergency procedure (p <0.001), and preprocedural shock (p <0.001). The C-statistic for 1-year mortality was 0.70 (95% confidence interval, 0.67 to 0.73). In conclusion, isolated tricuspid valve surgery is infrequently performed in the United States, and is associated with high 1-year mortality. Patients at higher risk for mortality can be identified based on the presence of a number of comorbidities at the time of surgery.