Transcatheter Pulmonary Valve Replacement in Middle and Late Adulthood.

Transcatheter pulmonary valve replacement (TPVR) is now frequently performed in adult congenital heart disease (ACHD) patients. As the life-expectancy of the ACHD population continues to improve, more patients will require pulmonary valve intervention. This study details the short-term and mid-term clinical outcomes of patients aged 40 years and older undergoing TPVR. We performed an institutional retrospective cohort study that included patients aged 40 and older undergoing TPVR (and clinical follow up) from January 1, 2012 to January 1, 2024. Descriptive analyses, Kaplan-Meier survival analysis, and Cox proportional hazard modeling were utilized to determine outcomes and risk factors affecting survival. The study included 67 patients and median age at TPVR was 48 [43,57] years. Median hospital length of stay following TPVR was 1 [1,3] day, peri-procedural complications occurred in 5 patients and acute kidney injury occurred in 1 patient. Median duration of follow-up was 3.5 [0.1,9.7] years. There were 9 total deaths and 1, 3, and 5-year Kaplan-Meier survival after TPVR was 95%, 91%, and 82%, respectively. Moderate or worse right ventricular dysfunction was present in 22 patients before TPVR and in 20 patients after TPVR. Inpatient status prior to TPVR negatively impacted survival (HR = 24.7 [3.3, 186.1], p=0.002). In conclusion, TPVR was performed in patients ages 40 and older with favorable periprocedural and mid-term follow-up outcomes including survival, but right ventricular dysfunction did not improve and further exploration on ideal timing of TPVR in this age group is warranted.

Radiation Exposure Using Rampart vs Standard Lead Aprons and Shields During Invasive Cardiovascular Procedures.

Background: Radiation exposure during invasive cardiovascular procedures remains an important health care issue. Lead aprons and shields (LAS) are used to decrease radiation exposure but leave large portions of the body unshielded. The Rampart IC M1128 is a portable radiation shielding system that may significantly attenuate radiation exposure. Methods: Catheterization laboratory teams were randomized in a 1:1 fashion to perform elective invasive cardiovascular procedures utilizing either traditional LAS or the Rampart IC M1128. Radiation exposure was measured using real-time dosimetry monitoring in prespecified anatomic locations on 3 operators (position 1: first operator/fellow; position 2: second operator/attending; and position 3: catheterization laboratory nurse/technologist). Radiation exposure was measured on a per-case basis. Results: In total, 100 consecutive cases were randomized in this study (47 Rampart; 53 LAS). There was no difference in fluoroscopy time (12.3 minutes for Rampart vs 15.4 minutes for LAS; P = .52), dose area product (288 Gy⋅cm2 for Rampart vs 376.5 Gy⋅cm2 for LAS; P = .52), or scatter radiation (38.8 mRem for Rampart vs 46.8 mRem for LAS; P = .61) between the groups. There was significantly lower total body radiation (in milliroentgen equivalent man) exposure using the Rampart than that using LAS for each team member: position 1-0.1 mRem for Rampart vs 2.2 mRem for LAS; P < .001; position 2-0.1 mRem Rampart vs 3.2 mRem LAS; P < .001; and position 3-0.0 mRem for Rampart vs 0.8 mRem for LAS; P < .001. Conclusions: During routine clinical procedures, the Rampart system significantly decreases total body radiation exposure compared with traditional LAS.

Can We Six It? Double BASILICA Transcatheter Aortic Valve Replacement in Quadricuspid Aortic Valve.

Coronary artery obstruction is an uncommon yet devastating complication of transcatheter aortic valve replacement (TAVR) and may necessitate leaflet modification. A 38-year-old man presented to our center with quadricuspid aortic valve with severe aortic regurgitation. Double leaflet modification was performed with the Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA) technique prior to TAVR, creating 6 leaflets from 4. The patient tolerated the procedure well with symptomatic improvement. Follow-up transthoracic echocardiogram showed normal bioprosthetic aortic valve function. This case demonstrates feasibility of this procedure with comprehensive preprocedural analysis and intraprocedural imaging guidance.

Managing superior vena cava syndrome in patients with cardiac implantable electronic device leads: Strategies and considerations.

BACKGROUND: Data on transvenous (TV) lead-associated superior vena cava (SVC) syndrome are limited. The management of this problem might require a multidisciplinary approach, often involving transvenous lead extraction (TLE) followed by angioplasty and stenting. OBJECTIVE: The purpose of this study was to describe the management and outcome of TV lead-associated SVC syndrome. METHODS: We retrospectively identified patients with a diagnosis of SVC syndrome and TV leads at Emory Healthcare between 2015 and 2023. RESULTS: Fifteen patients with lead-related SVC syndrome were identified. The cohort average age was 50 years. Symptoms included swelling of the face, neck, and upper extremities (67%); shortness of breath (53%); and lightheadedness (40%). Patients had an average of 2 ± 0.7 leads crossing the SVC, with a lead dwell time of 9.8 ± 7.5 years. Thirteen patients were managed with TLE, followed by SVC stenting and angioplasty in 10 and angioplasty alone in 2; 1 patient had no intervention after TLE. One patient was managed with anticoagulation, and another had angioplasty and stenting with lead jailing. One patient experienced SVC perforation and cardiac tamponade during SVC stenting, which was managed successfully with a covered stent and pericardiocentesis. Among the 12 patients with TLE and angioplasty ± stenting, 7 underwent reimplantation of a transvenous lead. Two of those patients had symptoms recurrence, and none of the 5 patients without lead reimplantation had recurrence of symptoms. CONCLUSION: Lead-related SVC syndrome management requires a multidisciplinary approach often including TLE followed by angioplasty and stenting. Avoiding TV lead reimplantation might help reduce symptoms recurrence.

Clinical outcomes and predictors of transapical transcatheter mitral valve replacement: the Tendyne Expanded Clinical Study.

BACKGROUND: Transcatheter mitral valve replacement (TMVR) is a therapeutic option for patients with severe mitral regurgitation (MR) who are ineligible for conventional surgery. There are limited data on the outcomes of large patient cohorts treated with TMVR. AIMS: This study aimed to investigate the outcomes and predictors of mortality for patients treated with transapical TMVR. METHODS: This analysis represents the clinical experience of all patients enrolled in the Tendyne Expanded Clinical Study. Patients with symptomatic MR underwent transapical TMVR with the Tendyne system between November 2014 and June 2020. Outcomes and adverse events up to 2 years, as well as predictors of short-term mortality, were assessed. RESULTS: A total of 191 patients were treated (74.1±8.0 years, 62.8% male, Society of Thoracic Surgeons Predicted Risk of Mortality 7.7±6.6%). Technical success was achieved in 96.9% (185/191), and there were no intraprocedural deaths. At 30-day, 1- and 2-year follow-up, the rates of all-cause mortality were 7.9%, 30.8% and 40.5%, respectively. Complete MR elimination (MR <1+) was observed in 99.3%, 99.1% and 96.3% of patients, respectively. TMVR treatment resulted in consistent improvement of New York Heart Association Functional Class and quality of life up to 2 years (both p<0.001). Independent predictors of early mortality were age (odds ratio [OR] 1.11; p=0.003), pulmonary hypertension (OR 3.83; p=0.007), and institutional experience (OR 0.40; p=0.047). CONCLUSIONS: This study investigated clinical outcomes in the full cohort of patients included in the Tendyne Expanded Clinical Study. The Tendyne TMVR system successfully eliminated MR with no intraprocedural deaths, resulting in an improvement in symptoms and quality of life. Continued refinement of clinical and echocardiographic risks will be important to optimise longitudinal outcomes.

Predictors and 5-Year Clinical Outcomes of Pacemaker After TAVR: Analysis From the PARTNER 2 SAPIEN 3 Registries.

BACKGROUND: Conduction disturbances requiring a permanent pacemaker (PPM) are a frequent complication of transcatheter aortic valve replacement (TAVR) with few reports of rates, predictors, and long-term clinical outcomes following implantation of the third-generation, balloon-expandable SAPIEN 3 (S3) transcatheter heart valve (THV). OBJECTIVES: The aim of this study was to investigate the rates, predictors, and long-term clinical outcomes of PPM implantation following TAVR with the S3 THV. METHODS: The current study included 857 patients in the PARTNER 2 S3 registries with intermediate and high surgical risk without prior PPM, and investigated predictors and 5-year clinical outcomes of new PPM implanted within 30 days of TAVR. RESULTS: Among 857 patients, 107 patients (12.5%) received a new PPM within 30 days after TAVR. By multivariable analysis, predictors of PPM included increased age, pre-existing right bundle branch block, larger THV size, greater THV oversizing, moderate or severe annulus calcification, and implantation depth >6 mm. At 5 years (median follow-up 1,682.0 days [min 2.0 days, max 2,283.0 days]), new PPM was not associated with increased rates of all-cause mortality (Adj HR: 1.20; 95% CI: 0.85-1.70; P = 0.30) or repeat hospitalization (Adj HR: 1.22; 95% CI: 0.67-2.21; P = 0.52). Patients with new PPM had a decline in left ventricular ejection fraction at 1 year that persisted at 5 years (55.1 ± 2.55 vs 60.4 ± 0.65; P = 0.02). CONCLUSIONS: PPM was required in 12.5% of patients without prior PPM who underwent TAVR with a SAPIEN 3 valve in the PARTNER 2 S3 registries and was not associated with worse clinical outcomes, including mortality, at 5 years. Modifiable factors that may reduce the PPM rate include bioprosthetic valve oversizing, prosthesis size, and implantation depth.

Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms (VINTAGE): Deep Ablation in Inaccessible Targets.

BACKGROUND: Deep intramural ventricular tachycardia substrate targets are difficult to access, map, and ablate from endocardial and epicardial surfaces, resulting in high recurrence rates. OBJECTIVES: In this study, the authors introduce a novel approach called ventricular intramyocardial navigation for tachycardia ablation guided by electrograms (VINTAGE) to access and ablate anatomically challenging ventricular tachycardia from within the myocardium. METHODS: Guidewire/microcatheter combinations were navigated deep throughout the extravascular myocardium, accessed directly from the right ventricle cavity, in Yorkshire swine (6 naive, 1 infarcted). Devices were steered to various intramyocardial targets including the left ventricle summit, guided by fluoroscopy, unipolar electrograms, and/or electroanatomic mapping. Radiofrequency ablations were performed to characterize ablation parameters and reproducibility. Intramyocardial saline irrigation began 1 minute before ablation and continued throughout. Lesions were analyzed on cardiac magnetic resonance and necropsy. RESULTS: VINTAGE was feasible in all animals within naive and infarcted myocardium. Forty-three lesions were created, using various guidewires and power settings. Forty-one (95%) lesions were detected on cardiac magnetic resonance and 38 (88%) on necropsy; all undetected lesions resulted from intentionally subtherapeutic ablation energy (10 W). Larger-diameter guidewires yielded larger size lesions. Lesion volumes on necropsy were significantly larger at 20 W than 10 W (178 mm3 [Q1-Q3: 104-382 mm3] vs 49 mm3 [Q1-Q3: 35-93 mm3]; P = 0.02). Higher power (30 W) did not create larger lesions. Median impedance dropped with preablation irrigation by 12 Ω (Q1-Q3: 8-17 Ω), followed by a further 15-Ω (Q1-Q3: 11-19 Ω) drop during ablation. Intramyocardial navigation, ablation, and irrigation were not associated with any complications. CONCLUSIONS: VINTAGE was safe and effective at creating intramural ablation lesions in targets traditionally considered inaccessible from the endocardium and epicardium, both naive and infarcted. Intramyocardial guidewire irrigation and ablation at 20 W creates reproducibly large intramural lesions.

Impact of Tricuspid Regurgitation on Outcomes After Transcatheter Mitral Valve Replacement.

Development of functional tricuspid regurgitation (TR) because of chronic mitral disease and subsequent heart failure is common. However, the effect of TR on clinical outcomes after transcatheter mitral valve replacement (TMVR) remains unclear. We aimed to evaluate the impact of baseline TR on outcomes after TMVR. This was a single-center, retrospective analysis of patients who received valve-in-valve or valve-in-ring TMVR between 2012 and 2022. Patients were categorized into none/mild TR and moderate/severe TR based on baseline echocardiography. The primary outcome was 3 years all-cause death and the secondary outcomes were in-hospital events. Of the 135 patients who underwent TMVR, 64 (47%) exhibited none/mild TR at baseline, whereas 71 (53%) demonstrated moderate/severe TR. There were no significant differences in in-hospital events between the groups. At 3 years, the moderate/severe TR group exhibited a significantly increased risk of all-cause death (adjusted hazard ratio 3.37, 95% confidence interval 1.35 to 8.41, p = 0.009). When patients with baseline moderate/severe TR were stratified by echocardiography at 30 days into improved (36%) and nonimproved (64%) TR groups, although limited by small sample size, there was no significant difference in 3-year all-cause mortality (p = 0.48). In conclusion, this study investigating the impact of baseline TR on clinical outcomes revealed that moderate/severe TR is prevalent in those who underwent TMVR and is an independent predictor of 3-year all-cause mortality. Earlier mitral valve intervention before the development of significant TR may play a pivotal role in improving outcomes after TMVR.

Contemporary 1-Year Outcomes of Mitral Valve-in-Ring With Balloon-Expandable Aortic Transcatheter Valves in the U.S.

BACKGROUND: Adequate valve performance after surgical mitral valve repair with an annuloplasty ring is not always sustained over time. The risk of repeat mitral valve surgery may be high in these patients. Transcatheter mitral valve-in-ring (MViR) is emerging as an alternative for high-risk patients. OBJECTIVES: The authors sought to assess contemporary outcomes of MViR using third-generation balloon-expandable aortic transcatheter heart valves. METHODS: Patients who underwent MViR and were enrolled in the STDS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between August 2015 and December 2022 were analyzed. RESULTS: A total of 820 patients underwent MViR at 236 sites, mean age was 72.2 ± 10.4 years, 50.9% were female, mean STS score was 8.2% ± 6.9%, and most (78%) were in NYHA functional class III to IV. Mean left ventricular ejection fraction was 47.8% ± 14.2%, mean mitral gradient was 8.9 ± 7.0 mm Hg, and 75.5% had ≥ moderate mitral regurgitation. Access was transseptal in 93.9% with 88% technical success. All-cause mortality at 30 days was 8.3%, and at 1 year, 22.4%, with a reintervention rate of 9.1%. At 1-year follow-up, 75.6% were NYHA functional class I to II, Kansas City Cardiomyopathy Questionnaire score increased by 25.9 ± 29.1 points, mean mitral valve gradient was 8.4 ± 3.4 mm Hg, and 91.7% had ≤ mild mitral regurgitation. CONCLUSIONS: MViR with third-generation balloon-expandable aortic transcatheter heart valves is associated with a significant reduction in mitral regurgitation and improvement in symptoms at 1 year, but with elevated valvular gradients and a high reintervention rate. MViR is a reasonable alternative for high-risk patients unable undergo surgery who have appropriate anatomy for the procedure. (STS/ACC TVT Registry Mitral Module [TMVR]; NCT02245763).

TABERNACL: Temporary Hemodynamic Stabilization In Vivo.

BACKGROUND: Acute aortic regurgitation is life-threatening with few nonsurgical options for immediate stabilization. We propose Trans-Aortic Balloon to Ease Regurgitation Applying Counter-Pulsation (TABERNACL), a simple, on-table temporary valve using commercially available equipment to temporize acute severe aortic regurgitation. METHODS: We hypothesize that an appropriately sized commercial balloon dilatation catheter-straddling the aortic annulus and connected to a counterpulsation console-can serve as a temporizing valve to restore hemodynamic stability in acute aortic regurgitation. We performed benchtop testing of valvuloplasty, angioplasty, and sizing balloons as counterpulsation balloons. TABERNACL was assessed in vivo in a porcine model of acute aortic regurgitation (n=8). We also tested a static undersized, continuously inflated transvalvular balloon as a spacer intended physically to obstruct the regurgitant orifice. RESULTS: Benchtop testing identified that Tyshak II and PTS sizing (NuMed Braun) balloon catheters performed adequately as temporary valves (ie, complete inflation and deflation with each cycle) and resisted fatigue, in contrast to others. When TABERNACL was used in the acute severe regurgitation animals, there was immediate hemodynamic improvement, with a significant 35% increase in diastolic aortic pressure by 16 mm Hg ([95% CI, 7-25] P=0.0056), 34% reduction in left ventricular end-diastolic pressure by -7 mm Hg ([95% CI, -10 to -5] P=0.0006), improvement in the aortic diastolic index by 0.28 ([95% CI, 0.18-0.39] P=0.0009), and reversal of electrocardiographic myocardial ischemia. As an alternative, static balloon inflation across the aortic valve stabilized regurgitation hemodynamics at the expense of a new aortic gradient and caused excessive ectopy from balloon movement in the left ventricular outflow tract. CONCLUSIONS: TABERNACL improves hemodynamics and reduces coronary ischemia by electrocardiography in animals with acute severe aortic regurgitation. TABERNACL valves obstruct the diastolic regurgitant orifice without systolic obstruction. This may prove a lifesaving bridge to definitive valve replacement therapy.

Transcatheter Myotomy to Reduce Left Ventricular Outflow Obstruction.

BACKGROUND: Left ventricular outflow tract (LVOT) obstruction is a source of morbidity in hypertrophic cardiomyopathy (HCM) and a life-threatening complication of transcatheter mitral valve replacement (TMVR) and transcatheter aortic valve replacement (TAVR). Available surgical and transcatheter approaches are limited by high surgical risk, unsuitable septal perforators, and heart block requiring permanent pacemakers. OBJECTIVES: The authors report the initial experience of a novel transcatheter electrosurgical procedure developed to mimic surgical myotomy. METHODS: We used septal scoring along midline endocardium (SESAME) to treat patients, on a compassionate basis, with symptomatic LVOT obstruction or to create space to facilitate TMVR or TAVR. RESULTS: In this single-center retrospective study between 2021 and 2023, 76 patients underwent SESAME. In total, 11 (14%) had classic HCM, and the remainder underwent SESAME to facilitate TMVR or TAVR. All had technically successful SESAME myocardial laceration. Measures to predict post-TMVR LVOT significantly improved (neo-LVOT 42 mm2 [Q1-Q3: 7-117 mm2] to 170 mm2 [Q1-Q3: 95-265 mm2]; P < 0.001; skirt-neo-LVOT 169 mm2 [Q1-Q3: 153-193 mm2] to 214 mm2 [Q1-Q3: 180-262 mm2]; P < 0.001). Among patients with HCM, SESAME significantly decreased invasive LVOT gradients (resting: 54 mm Hg [Q1-Q3: 40-70 mm Hg] to 29 mm Hg [Q1-Q3: 12-36 mm Hg]; P = 0.023; provoked 146 mm Hg [Q1-Q3: 100-180 mm Hg] to 85 mm Hg [Q1-Q3: 40-120 mm Hg]; P = 0.076). A total of 74 (97.4%) survived the procedure. Five experienced 3 of 76 (3.9%) iatrogenic ventricular septal defects that did not require repair and 3 of 76 (3.9%) ventricular free wall perforations. Neither occurred in patients treated for HCM. Permanent pacemakers were required in 4 of 76 (5.3%), including 2 after concomitant TAVR. Lacerations were stable and did not propagate after SESAME (remaining septum: 5.9 ± 3.3 mm to 6.1 ± 3.2 mm; P = 0.8). CONCLUSIONS: With further experience, SESAME may benefit patients requiring septal reduction therapy for obstructive hypertrophic cardiomyopathy as well as those with LVOT obstruction after heart valve replacement, and/or can help facilitate transcatheter valve implantation.

Left Ventricular Outflow Tract Modification for Transcatheter Mitral Valve Replacement.

Left ventricular outflow tract (LVOT) obstruction is a life-threatening complication of transcatheter mitral valve replacement. In-depth analysis of pre-procedural computed tomography enables accurate prediction of this risk. Several techniques for LVOT modification, including Laceration of the Anterior Mitral leaflet to Prevent Outflow ObtructioN, preemptive alcohol septal ablation, preemptive radiofrequency ablation, and Septal Scoring Along the Midline Endocardium, have been described as effective strategies to mitigate this risk. This review aims to explore the indications, procedural steps, and outcomes associated with these LVOT modification techniques.

Transcatheter Paravalvular Leak Closure With Covered Stent Tract and Vascular Plug: Tootsie Roll Technique.

BACKGROUND: Transcatheter closure of transcatheter heart valve (THV)-related paravalvular leak (PVL) is associated with a high failure rate with available devices due to the complex interaction of THV and aortic/mitral annulus. OBJECTIVES: This study reports on novel transcatheter techniques to treat PVL after THV. METHODS: The authors describe consecutive patients who underwent PVL closure after transcatheter aortic valve replacement (TAVR) or transcatheter mitral valve replacement (TMVR). A covered self-expanding stent (Viabahn) was deployed in the defect to create a seal between the THV and annulus. A vascular plug (Amplatzer Vascular Plug 2 [AVP2] or AVP4) was then deployed inside the covered stent to obliterate PVL. RESULTS: Eight patients with THV-related PVL were treated using this method (aortic [3 SAPIEN, 1 Evolut], mitral [2 SAPIEN-in-MAC (mitral annular calcification), 2 M3 TMVR). Various combinations of stents and plugs were used (5 mm × 2.5 cm Viabahn + 6 mm AVP4 [n = 2], 8 mm × 2.5 cm Viabahn + 10 mm AVP2 [n = 5], and 10 mm × 5.0 cm Viabahn + 12 mm AVP2 [n = 1]). All had technical success with immediate elimination of target PVL, without in-hospital complications. None had signs of postprocedure hemolysis. All patients were discharged alive (median 3.5 days [Q1-Q3: 1.0-4.8 days]). No residual PVL was seen at discharge, except for 1 patient with mild regurgitation due to another untreated PVL location. One patient died before 30 days due to complication of valve-in-MAC TMVR. In remaining patients, none had recurrence of PVL at 30 days. Symptoms decreased to NYHA functional class I/II in 6 patients. NYHA functional class III symptoms remained in 1 patient with mitral regurgitation awaiting subsequent valve replacement procedure. CONCLUSIONS: The technique of sequential deployment of a covered stent and vascular plug may effectively treat THV-related PVL.

Effect of Ascending Aortic Curvature on Flow in the Sinus and Neo-sinus Following TAVR: A Patient-Specific Study.

Patient-specific aortic geometry and its influence on the flow in the vicinity of Transcatheter Aortic Valve (TAV) has been highlighted in numerous studies using both in silico and in vitro experiments. However, there has not yet been a detailed Particle Image Velocimetry (PIV) experiment conducted to quantify the relationship between the geometry, flow downstream of TAV, and the flow in the sinus and the neo-sinus. We tested six different patient-specific aorta models with a 26-mm SAPIEN 3 valve (Edwards Lifesciences, Irvine, CA, USA) in a left heart simulator with coronary flow. Velocities in all three cusps and circulation downstream of TAV were computed to evaluate the influence of the ascending aorta curvature on the flow field. The in vitro analysis showed that the patient-specific aortic curvature had positive correlation to the circulation in the ascending aorta (p = 0.036) and circulation had negative correlation to the particle washout time in the cusps (p = 0.011). These results showed that distinct vortical flow patterns in the ascending aorta as the main jet impinges on the aortic wall causes a recirculation region that facilitates the flow back into the sinus and the neo-sinus, thus reducing the risk of flow stagnation and washout time.

Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study.

BACKGROUND AND AIMS: For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Longer-term follow-up is needed to confirm sustained improvements in these outcomes. METHODS: The prospective, single-arm, multicentre TRISCEND study enrolled 176 patients to evaluate the safety and performance of transcatheter TV replacement in patients with ≥moderate, symptomatic TR despite medical therapy. Major adverse events, reduction in TR grade and haemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year. RESULTS: Enrolled patients were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III-IV. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8 mL, P < .001) and cardiac output (0.6 ± 1.2 L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2 m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure. CONCLUSIONS: In an elderly, highly comorbid population with ≥moderate TR, patients receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. Funded by Edwards Lifesciences, TRISCEND ClinicalTrials.gov number, NCT04221490.

Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years.

BACKGROUND: A previous analysis in this trial showed that among patients with severe, symptomatic aortic stenosis who were at low surgical risk, the rate of the composite end point of death, stroke, or rehospitalization at 1 year was significantly lower with transcatheter aortic-valve replacement (TAVR) than with surgical aortic-valve replacement. Longer-term outcomes are unknown. METHODS: We randomly assigned patients with severe, symptomatic aortic stenosis and low surgical risk to undergo either TAVR or surgery. The first primary end point was a composite of death, stroke, or rehospitalization related to the valve, the procedure, or heart failure. The second primary end point was a hierarchical composite that included death, disabling stroke, nondisabling stroke, and the number of rehospitalization days, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, and health-status outcomes were assessed through 5 years. RESULTS: A total of 1000 patients underwent randomization: 503 patients were assigned to undergo TAVR, and 497 to undergo surgery. A component of the first primary end point occurred in 111 of 496 patients in the TAVR group and in 117 of 454 patients in the surgery group (Kaplan-Meier estimates, 22.8% in the TAVR group and 27.2% in the surgery group; difference, -4.3 percentage points; 95% confidence interval [CI], -9.9 to 1.3; P = 0.07). The win ratio for the second primary end point was 1.17 (95% CI, 0.90 to 1.51; P = 0.25). The Kaplan-Meier estimates for the components of the first primary end point were as follows: death, 10.0% in the TAVR group and 8.2% in the surgery group; stroke, 5.8% and 6.4%, respectively; and rehospitalization, 13.7% and 17.4%. The hemodynamic performance of the valve, assessed according to the mean (±SD) valve gradient, was 12.8±6.5 mm Hg in the TAVR group and 11.7±5.6 mm Hg in the surgery group. Bioprosthetic-valve failure occurred in 3.3% of the patients in the TAVR group and in 3.8% of those in the surgery group. CONCLUSIONS: Among low-risk patients with severe, symptomatic aortic stenosis who underwent TAVR or surgery, there was no significant between-group difference in the two primary composite outcomes. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).