Heart failure medical therapy prior to mitral transcatheter edge-to-edge repair: the STS/ACC Transcatheter Valve Therapy Registry.

BACKGROUND AND AIMS: Guideline-directed medical therapy (GDMT) is recommended before mitral valve transcatheter edge-to-edge repair (MTEER) in patients with heart failure (HF) and severe functional mitral regurgitation (FMR). Whether MTEER is being performed on the background of optimal GDMT in clinical practice is unknown. METHODS: Patients with left ventricular ejection fraction (LVEF) < 50% who underwent MTEER for FMR from 23 July 2019 to 31 March 2022 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry were identified. Pre-procedure GDMT utilization was assessed. Cox proportional hazards models were constructed to evaluate associations between pre-MTEER therapy (no/single, double, or triple therapy) and risk of 1-year mortality or HF hospitalization (HFH). RESULTS: Among 4199 patients across 449 sites, beta-blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, mineralocorticoid receptor antagonists, and angiotensin receptor-neprilysin inhibitors were used in 85.1%, 44.4%, 28.6%, and 19.9% before MTEER, respectively. Triple therapy was prescribed for 19.2%, double therapy for 38.2%, single therapy for 36.0%, and 6.5% were on no GDMT. Significant centre-level variation in the proportion of patients on pre-intervention triple therapy was observed (0%-61%; adjusted median odds ratio 1.48 [95% confidence interval (CI) 1.25-3.88]; P < .001). In patients eligible for 1-year follow-up (n = 2014; 341 sites), the composite rate of 1-year mortality or HFH was lowest in patients prescribed triple therapy (23.0%) compared with double (24.8%), single (35.7%), and no (41.1%) therapy (P < .01 comparing across groups). Associations persisted after accounting for relevant clinical characteristics, with lower risk in patients prescribed triple therapy [adjusted hazard ratio (aHR) 0.73, 95% CI .55-.97] and double therapy (aHR 0.69, 95% CI .56-.86) before MTEER compared with no/single therapy. CONCLUSIONS: Under one-fifth of patients with LVEF <50% who underwent MTEER for FMR in this US nationwide registry were prescribed comprehensive GDMT, with substantial variation across sites. Compared with no/single therapy, triple and double therapy before MTEER were independently associated with reduced risk of mortality or HFH 1 year after intervention.

The case for a qualitative lesion assessment system for coronary angiography.

Since the advent of coronary angiography, the standard for reporting of coronary lesion severity has been to utilize percent diameter stenosis (%DS). Given the imperfections of %DS as well as the widespread availability of intraprocedural intracoronary imaging and physiology assessment, it is time to consider a simpler yet more clinically relevant lesion assessment system. We compiled ten actual cases and presented these cases to 10 operators, providing 100 independent lesion assessments. For each case, operators were asked to describe lesions using %DS and a simplified lesion assessment system. We assessed the relationship between %DS and qualitative lesion assessment as well as the relationship of both measurements to the chosen plan. Greater variability exists with %DS than with qualitative lesion assessment. Despite this, there is good correlation between %DS and the qualitative lesion assessment (ρ = 0.8221). There remains overlap of lesion assessment using the qualitative lesion assessment tool suggesting that even with this simpler tool, there remains interobserver variability (ICC = 0.5164, 95% confidence interval [CI] 0.2924-0.7955). When assessing how both lesion assessment, there appears to be a stronger correlation between the qualitative lesion assessment and the chosen plan versus the %DS and the chosen plan (ρ = 0.9069 vs ρ = 0.8001, P < .01). Given the superior performance of the proposed qualitative system and the ability to estimate lesion severity using both anatomic and clinical factors, we feel that professional societies and clinicians should begin to embrace this simplified means of lesion assessment.

Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke Among Patients at Low Surgical Risk.

Importance: There are limited data on outcomes of transcatheter aortic valve replacement (TAVR) for bicuspid aortic stenosis in patients at low surgical risk. Objective: To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis in patients who are at low surgical risk. Design, Setting, and Participants: Registry-based cohort study of patients undergoing TAVR at 684 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapies Registry from June 2015 to October 2020. Among 159 661 patients (7058 bicuspid, 152 603 tricuspid), 37 660 patients (3243 bicuspid and 34 417 tricuspid) who were at low surgical risk (defined as STS risk score <3%) were included in the analysis. Exposures: TAVR for bicuspid vs tricuspid aortic stenosis. Main Outcomes and Measures: Coprimary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications and valve hemodynamics. Results: Among 159 661 patients (7058 bicuspid; 152 603 tricuspid), 3168 propensity-matched pairs of patients with bicuspid and tricuspid aortic stenosis at low surgical risk were analyzed (mean age, 69 years; 69.8% men; mean [SD] STS-predicted risk of mortality, 1.7% [0.6%] for bicuspid and 1.7% [0.7%] for tricuspid). There was no significant difference between the bicuspid and tricuspid groups' rates of death at 30 days (0.9% vs 0.8%; hazard ratio [HR], 1.18 [95% CI, 0.68-2.03]; P = .55) and at 1 year (4.6% vs 6.6%; HR, 0.75 [95% CI, 0.55-1.02]; P = .06) or stroke at 30 days (1.4% vs 1.2%; HR, 1.14 [95% CI, 0.73-1.78]; P = .55) and at 1 year (2.0% vs 2.1%; HR 1.03 [95% CI, 0.69-1.53]; P = .89).There were no significant differences between the bicuspid and tricuspid groups in procedural complications, valve hemodynamics (aortic valve gradient: 13.2 mm Hg vs 13.5 mm Hg; absolute risk difference [RD], 0.3 mm Hg [95% CI, -0.9 to 0.3 mm Hg]), and moderate or severe paravalvular leak (3.4% vs 2.1%; absolute RD, 1.3% [95% CI, -0.6% to 3.2%]). Conclusions and Relevance: In this preliminary, registry-based study of propensity-matched patients at low surgical risk who had undergone TAVR for aortic stenosis, patients treated for bicuspid vs tricuspid aortic stenosis had no significant difference in mortality or stroke at 30 days or 1 year. Because of the potential for selection bias and absence of a control group treated surgically for bicuspid aortic stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis in patients at low surgical risk.

Triage considerations for patients referred for structural heart disease intervention during the COVID-19 pandemic: An ACC/SCAI position statement.

The coronavirus disease-2019 (COVID-19) pandemic has strained health care resources around the world, causing many institutions to curtail or stop elective procedures. This has resulted in an inability to care for patients with valvular and structural heart disease in a timely fashion, potentially placing these patients at increased risk for adverse cardiovascular complications, including CHF and death. The effective triage of these patients has become challenging in the current environment, as clinicians have had to weigh the risk of bringing susceptible patients into the hospital environment during the COVID-19 pandemic against the risk of delaying a needed procedure. In this document, the authors suggest guidelines for how to triage patients in need of structural heart disease interventions and provide a framework for how to decide when it may be appropriate to proceed with intervention despite the ongoing pandemic. In particular, the authors address the triage of patients in need of transcatheter aortic valve replacement and percutaneous mitral valve repair. The authors also address procedural issues and considerations for the function of structural heart disease teams during the COVID-19 pandemic.

Prediction for residual regurgitation after MitraClip for functional mitral regurgitation using leaflet coaptation index.

BACKGROUND: Given the recent growth in the number of MitraClip procedures in patients with functional mitral regurgitation (MR), there is interest in an echocardiographic index to predict technical success before intervention. We investigated the utility of a novel leaflet coaptation index (LCI) to predict outcomes after MitraClip in functional MR patients. METHODS: Forty consecutive patients with functional MR who underwent MitraClip were included. The LCI was defined as the coapted leaflet length divided by the anteroposterior diameter of the mitral annulus. The coapted leaflet length was calculated by separately tracing the total length of the mitral valve leaflets at early and end systole on transesophageal echocardiography. The primary endpoint was defined as residual MR ≥ moderate after MitraClip. RESULTS: The LCI was significantly associated with residual MR ≥ moderate (odds ratio, 0.827; 95% confidence interval, 0.696-0.982; p = .030) with the cut-off LCI value of 0.14 (sensitivity 70.4%, specificity 69.2%, c-statistic 0.815; p = .001). CONCLUSION: This novel index may be a useful adjunct that can be incorporated into the armamentarium of contemporary clinical performance risk prediction tools for MitraClip success.

Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke.

Importance: Transcatheter aortic valve replacement (TAVR) indications are expanding, leading to an increasing number of patients with bicuspid aortic stenosis undergoing TAVR. Pivotal randomized trials conducted to obtain US Food and Drug Administration approval excluded bicuspid anatomy. Objective: To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis. Design, Setting, and Participants: Registry-based prospective cohort study of patients undergoing TAVR at 552 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies Registry from June 2015 to November 2018. Exposures: TAVR for bicuspid vs tricuspid aortic stenosis. Main Outcomes and Measures: Primary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications, valve hemodynamics, and quality of life assessment. Results: Of 81 822 consecutive patients with aortic stenosis (2726 bicuspid; 79 096 tricuspid), 2691 propensity-score matched pairs of bicuspid and tricuspid aortic stenosis were analyzed (median age, 74 years [interquartile range {IQR}, 66-81 years]; 39.1%, women; mean [SD] STS-predicted risk of mortality, 4.9% [4.0%] and 5.1% [4.2%], respectively). All-cause mortality was not significantly different between patients with bicuspid and tricuspid aortic stenosis at 30 days (2.6% vs 2.5%; hazard ratio [HR], 1.04, [95% CI, 0.74-1.47]) and 1 year (10.5% vs 12.0%; HR, 0.90 [95% CI, 0.73-1.10]). The 30-day stroke rate was significantly higher for bicuspid vs tricuspid aortic stenosis (2.5% vs 1.6%; HR, 1.57 [95% CI, 1.06-2.33]). The risk of procedural complications requiring open heart surgery was significantly higher in the bicuspid vs tricuspid cohort (0.9% vs 0.4%, respectively; absolute risk difference [RD], 0.5% [95% CI, 0%-0.9%]). There were no significant differences in valve hemodynamics. There were no significant differences in moderate or severe paravalvular leak at 30 days (2.0% vs 2.4%; absolute RD, 0.3% [95% CI, -1.3% to 0.7%]) and 1 year (3.2% vs 2.5%; absolute RD, 0.7% [95% CI, -1.3% to 2.7%]). At 1 year there was no significant difference in improvement in quality of life between the groups (difference in improvement in the Kansas City Cardiomyopathy Questionnaire overall summary score, -2.4 [95% CI, -5.1 to 0.3]; P = .08). Conclusions and Relevance: In this preliminary, registry-based study of propensity-matched patients who had undergone transcatheter aortic valve replacement for aortic stenosis, patients with bicuspid vs tricuspid aortic stenosis had no significant difference in 30-day or 1-year mortality but had increased 30-day risk for stroke. Because of the potential for selection bias and the absence of a control group treated surgically for bicuspid stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis.

Diagnosis, Treatment, and Long-Term Management of Kawasaki Disease: A Scientific Statement for Health Professionals From the American Heart Association.

BACKGROUND: Kawasaki disease is an acute vasculitis of childhood that leads to coronary artery aneurysms in ≈25% of untreated cases. It has been reported worldwide and is the leading cause of acquired heart disease in children in developed countries. METHODS AND RESULTS: To revise the previous American Heart Association guidelines, a multidisciplinary writing group of experts was convened to review and appraise available evidence and practice-based opinion, as well as to provide updated recommendations for diagnosis, treatment of the acute illness, and long-term management. Although the cause remains unknown, discussion sections highlight new insights into the epidemiology, genetics, pathogenesis, pathology, natural history, and long-term outcomes. Prompt diagnosis is essential, and an updated algorithm defines supplemental information to be used to assist the diagnosis when classic clinical criteria are incomplete. Although intravenous immune globulin is the mainstay of initial treatment, the role for additional primary therapy in selected patients is discussed. Approximately 10% to 20% of patients do not respond to initial intravenous immune globulin, and recommendations for additional therapies are provided. Careful initial management of evolving coronary artery abnormalities is essential, necessitating an increased frequency of assessments and escalation of thromboprophylaxis. Risk stratification for long-term management is based primarily on maximal coronary artery luminal dimensions, normalized as Z scores, and is calibrated to both past and current involvement. Patients with aneurysms require life-long and uninterrupted cardiology follow-up. CONCLUSIONS: These recommendations provide updated and best evidence-based guidance to healthcare providers who diagnose and manage Kawasaki disease, but clinical decision making should be individualized to specific patient circumstances.

Impact of flow, gradient, and left ventricular function on outcomes after transcatheter aortic valve replacement.

OBJECTIVES: To assess the impact of low flow with and without preserved left ventricular ejection fraction (LVEF) on outcomes after transcatheter aortic valve replacement (TAVR). BACKGROUND: Prior studies have shown that patients with low flow, AVG, and LVEF have worse outcomes after TAVR. It is unclear whether low AVG and LVEF remain prognostic after adjusting for flow, and how the outcomes of patients with low flow with and without preserved LVEF compare after TAVR. The goal of this study was to provide insight into these open questions. METHODS: Data from 340 TAVR patients at Brigham and Women's Hospital from 2011 through 2015 were analyzed. Low flow was defined as stroke volume index (SVI) ≤35 mL/m2 , low AVG as mean gradient < 40 mmHg, and reduced LVEF as < 50%. RESULTS: Low flow was present in 96 (28.2%) patients, 48 (50.0%) of whom also had reduced LVEF. At 1 year, low flow was associated with increased mortality (21.9 vs 7.4%; P = 0.0002) and heart failure (HF) (20.8 vs 5.3%; P = 0.0113). Among patients with low flow, those with preserved LVEF had increased mortality (HR 5.17, 95% CI 2.73-9.80; P < 0.001) and HF (HR 7.69, 95% CI 3.86-15.31; P < 0.001). After adjusting for clinical factors, patients with low flow had increased mortality (HR 6.51, 95% CI 2.98-14.22; P < 0.001) and HF (HR 5.52, 95% CI 2.34-12.98; P < 0.001), while neither low AVG nor low LVEF were associated with increases in mortality or HF. CONCLUSIONS: In patients undergoing TAVR, low flow was an independent predictor of 1-year mortality and HF, and a stronger predictor than either low AVG or LVEF. Patients with low flow and preserved EF had increased mortality and HF at 1-year, while those with low flow and reduced EF had outcomes similar to patients with normal flow.

Clinical Significance of Greater Implantation Height with SAPIEN 3 Transcatheter Heart Valve.

BACKGROUND: A lower rate of permanent pacemaker (PPM) has been linked to a target aortic implantation height (AIH) >0.70, following transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve. Based on clinical experience, it was hypothesized that a higher AIH (≥0.85) would lower the rate of PPM implantation. METHODS: A total of 127 patients (66 females, 61 males; mean age 82 ± 8 years) underwent TAVR with the SAPIEN 3 valve between May 2015 and July 2016. AIH was defined as the proportion of the valve frame above the aortic annulus in the post-deployment aortogram. A target AIH (≥0.70) was achieved in 113 patients (89%). Cases were stratified into a High Implantation (HI) group (AIH ≥0.85; 33 patients) or a Standard Implantation (SI) group (AIH <0.85; 94 patients). RESULTS: The mean Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score of all patients was 6.4 ± 3.5%. Preoperative right bundle branch block (RBBB) was prevalent in 13% of SI patients, and in 18% of HI patients (p = 0.56). There were no significant differences in operative mortality (3.2% versus 0%), median length of stay (2 days versus 3 days) and incidence of moderate-to-severe paravalvular leak (3.2% versus 0%; all p >0.410) between SI and HI patients, respectively. Likewise, the incidence of new PPM did not differ between the two groups (12% in HI versus 13% in SI; p ≥0.99). The mean AIH was similar for patients with PPM implantation (0.80 ± 0.08) compared to those without (0.78 ± 0.06; p = 0.520). Preoperative RBBB was significantly associated with PPM implantation (odds ratio (OR) 10.1; p = 0.002), and patients who underwent PPM implantation had a higher operative mortality (12.5% versus 1%; p = 0.040). CONCLUSIONS: Among TAVR patients who received the SAPIEN 3 heart valve, a higher AIH (≥0.85) was not associated with a lower rate of PPM implantation or increased operative mortality. Prior RBBB was the only independent risk factor for new PPM implantation. Long-term follow up is crucial in determining the clinical significance of PPM implantation.

Transcatheter Intervention of Coronary Obstructions in Infants, Children, and Young Adults.

This study assesses the characteristics of coronary obstructions that underwent transcatheter intervention in a pediatric catheterization laboratory, the procedural details, and patient outcomes. Acute cardiac failure due to coronary obstructions in children is rare. The role of catheter based intervention is largely unreported. Single center retrospective review between January 2000 and December 2016. Thirty-three patients (median age 2y/o [0-38], weighing 9.6 kg [2.2-91]) underwent 39 transcatheter interventions on 39 lesions, mainly left main coronary (16/39; 39%) and right coronary (9/39; 23%) arteries. Most patients had congenital heart disease (29/33; 88%). Cath indications included ventricular dysfunction (17), cardiac arrest (7), failure to wean from cardiopulmonary bypass (5), and other (4). Almost half (18/39; 46%) were performed on ECMO support. Obstructions were post-surgical (16; 4 with coronary manipulation), thrombotic (13; 5 < 30 days from cardiac surgery), and miscellaneous lesions (10). Interventions included 25 bare metal stents implanted in 22 lesions in 17 patients (mainly post-surgical lesions; 3 at Damus-Kaye-Stansel anastomosis), nine balloon angioplasty only, four lytic therapy ± mechanical disruption of thrombus, and four technical failures. There were no procedure-related deaths. Most patients survived to discharge or transplant (24/33; 73%). Six patients who received stents had follow-up catheterization (median 15.5 months [1-106]); all were without restenosis. Most coronary obstructions intervened upon in a pediatric cath lab were on young, critically ill patients with congenital heart disease secondary to surgical manipulation/injury or thrombosis. Transcatheter intervention should be considered a potential treatment strategy in this population.

Transthoracic Echocardiography to Assess Aortic Regurgitation after TAVR: A Comparison with Periprocedural Transesophageal Echocardiography.

BACKGROUND: We aimed to compare periprocedural transesophageal echocardiography (TEE) with postprocedural transthoracic echocardiography (TTE) for the diagnosis of aortic regurgitation (AR). METHODS AND RESULTS: TEE and TTE images of 163 transcatheter aortic valve replacement (TAVR) patients (mean age 81 ± 8 years; 56% men) were reviewed separately and blinded to each other as well as to all clinical data. The median time between TEE during TAVR (TEE/TAVR) and TTE was 4 days (IQR 2-10 days). After TAVR, 48% of the patients had at least trace AR by TEE, 56% by angiography and 67% by TTE. The majority of AR was paravalvular (78%). More patients were classified with mild-to-moderate AR by TTE than by TEE (44 vs. 22%, p < 0.01). When examining the 46 patients with AR by TTE which was not at TEE/TAVR, both systolic and diastolic blood pressure (SBP and DBP) were significantly higher during TTE than during TEE (mean ΔSBP = 9 ± 4 mm Hg and mean ΔDBP = 6 ± 2 mm Hg, p < 0.01 for both). No differences in BP between TEE and TTE were found among patients with no AR or among those who had AR in both studies. At a median follow-up of 185 days (IQR 39-424 days), the overall mortality was 17%, but this was not associated with the presence of AR on TTE or TEE. CONCLUSIONS: Patients' hemodynamic conditions may result in underdiagnosis of paravalvular regurgitation in periprocedural TEE. Our findings suggest that a postprocedural evaluation for AR by TTE could serve as a reasonable alternative to TEE for the evaluation of AR.

Abdominal aorta as an alternative access route for transcatheter aortic valve replacement.

A variety of access routes have been employed for transcatheter aortic valve replacement (TAVR). We report a TAVR case using the abdominal aorta as the direct access route when other approaches are not feasible.

Outcomes and Safety of Transcaval Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-analysis.

BACKGROUND: The transcaval (TCv) vascular approach is increasingly used in transcatheter aortic valve replacement (TAVR) in patients unsuitable for the gold-standard transfemoral approach. We aimed to evaluate the efficacy, safety, and clinical outcomes associated with TCv-TAVR. METHODS: A systematic review and meta-analysis was conducted by searching PubMed/Medline, Embase, and the Cochrane Library for all articles assessing the TCv approach published through December 2023. Outcomes included 30-day and 1-year all-cause mortality (ACM), 30-day rehospitalisation, perioperative complications and postoperative complications at 30 days. The meta-analysis was registered on the PROSPERO database with the identifier CRD42024501921. RESULTS: A total of 8 studies with 467 patients were included. TCv-TAVR procedures achieved a success rate of 98.5%. TCv-TAVR was associated with a 30-day ACM rate of 6.1% (95% confidence interval [CI]: 3.9%-8.2%), a 1-year ACM rate of 14.9% (95% CI 2.3%-27.6%) and a 30-day rehospitalisation rate of 4.2% (95% CI -2.2% to 10.6%). Postoperative stroke or transient ischemic attack, major vascular complications, and major or life-threatening bleeding occurred in 3.3%, 8.7%, and 7.5% of cases, respectively. Cumulative meta-analyses showed a temporal trend of decreasing rates of vascular complications. CONCLUSIONS: The TCv approach in TAVR demonstrated a reassuring efficacy and safety profile, with mortality and postoperative complication rates similar to those reported for supra-aortic alternative TAVR access routes. The temporal decrease in vascular complications suggests potential improvements in procedural techniques and device technology. These findings further support the TCv approach as a viable option in patients ineligible for the transfemoral access. PROSPERO: CRD42024501921.

Comparison of Postdischarge Outcomes Between Valve-in-Valve Transcatheter Mitral Valve Replacement and Reoperative Surgical Mitral Valve Replacement.

Limited data are available comparing the postdischarge perioperative outcomes of isolated valve-in-valve transcatheter mitral valve replacement (VIV-TMVR) versus surgical reoperative mitral valve replacement (re-SMVR) on a nationwide scale. The objective of this study was to perform a robust head-to-head assessment of contemporary postdischarge outcomes between isolated VIV-TMVR and re-SMVR using a large national multicenter longitudinal database. Adult patients aged ≥18 years with failed/degenerated bioprosthetic mitral valves who underwent either isolated VIV-TMVR or re-SMVR were identified in the 2015 to 2019 Nationwide Readmissions Database. The risk-adjusted differences in 30-, 90-, and 180-day outcomes were compared using propensity score weighting with overlap weights to mimic the results of a randomized controlled trial. The differences between a transeptal and transapical VIV-TMVR approach were also compared. A total of 687 patients with VIV-TMVR and 2,047 patients with re-SMVR were included. After the overlap weighting to attain balance between treatment groups, VIV-TMVR was associated with significantly lower major morbidity within 30 (odds ratio [95% confidence interval (CI)] 0.0.31 [0.22 to 0.46]), 90 (0.34 [0.23 to 0.50]), and 180 (0.35 [0.24 to 0.51]) days. The differences in major morbidity were primarily driven by less major bleeding (0.20 [0.14 to 0.30]), new onset complete heart block (0.48 [0.28 to 0.84]) and need for permanent pacemaker placement (0.26 [0.12 to 0.55]). The differences in renal failure and stroke were not significant. VIV-TMVR was also associated with shorter index hospital stays (median difference [95% CI] -7.0 [4.9 to 9.1] days) and an increased ability for patients to be discharged home (odds ratio [95% CI] 3.35 [2.37 to 4.72]). There were no significant differences in total hospital costs; in-hospital or 30-, 90-, and 180-day mortality; or readmission. The findings remained similar when stratifying the VIV-TMVR access using a transeptal versus a transapical approach. The changes in outcomes over time suggest marked improvements for patients with VIV-TMVR relative to stagnant results for patients with re-SMVR from 2015 to 2019. In this large nationally representative cohort of patients with failed/degenerated bioprosthetic mitral valves, VIV-TMVR appears to confer a short-term advantage over re-SMVR in terms of morbidity, discharge home, and length of stay. It yielded equivalent outcomes for mortality and readmission. Longer-term studies are needed to assess further follow-up beyond 180 days.

One-Year Outcomes From the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation.

BACKGROUND: The CLASP IID (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical) trial is the first randomized controlled trial comparing the PASCAL system and the MitraClip system in prohibitive risk patients with significant symptomatic degenerative mitral regurgitation (DMR). OBJECTIVES: The study sought to report primary and secondary endpoints and 1-year outcomes for the full cohort of the CLASP IID trial. METHODS: Prohibitive-risk patients with 3+/4+ DMR were randomized 2:1 (PASCAL:MitraClip). One-year assessments included secondary effectiveness endpoints (mitral regurgitation [MR] ≤2+ and MR ≤1+), and clinical, echocardiographic, functional, and quality-of-life outcomes. Primary safety (30-day composite major adverse events [MAE]) and effectiveness (6-month MR ≤2+) endpoints were assessed for the full cohort. RESULTS: Three hundred patients were randomized (PASCAL: n = 204; MitraClip: n = 96). At 1 year, differences in survival, freedom from heart failure hospitalization, and MAE were nonsignificant (P > 0.05 for all). Noninferiority of the PASCAL system compared with the MitraClip system persisted for the primary endpoints in the full cohort (For PASCAL vs MitraClip, the 30-day MAE rates were 4.6% vs 5.4% with a rate difference of -0.8% and 95% upper confidence bound of 4.6%. The 6-month MR≤2+ rates were 97.9% vs 95.7% with a rate difference of 2.2% and 95% lower confidence bound (LCB) of -2.5%, for, respectively). Noninferiority was met for the secondary effectiveness endpoints at 1 year (MR≤2+ rates for PASCAL vs MitraClip were 95.8% vs 93.8% with a rate difference of 2.1% and 95% LCB of -4.1%. The MR≤1+ rates were 77.1% vs 71.3% with a rate difference of 5.8% and 95% LCB of -5.3%, respectively). Significant improvements in functional classification and quality of life were sustained in both groups (P <0.05 for all vs baseline). CONCLUSIONS: The CLASP IID trial full cohort met primary and secondary noninferiority endpoints, and at 1 year, the PASCAL system demonstrated high survival, significant MR reduction, and sustained improvements in functional and quality-of-life outcomes. Results affirm the PASCAL system as a beneficial therapy for prohibitive-surgical-risk patients with significant symptomatic DMR.

1-Year Outcomes of Transcatheter Edge-to-Edge Repair in Anatomically Complex Degenerative Mitral Regurgitation Patients.

BACKGROUND: Favorable 6-month outcomes from the CLASP IID Registry (Edwards PASCAL transcatheter valve repair system pivotal clinical trial) demonstrated that mitral valve transcatheter edge-to-edge repair with the PASCAL transcatheter valve repair system is safe and beneficial for treating prohibitive surgical risk degenerative mitral regurgitation (DMR) patients with complex mitral valve anatomy. OBJECTIVES: The authors sought to assess 1-year safety, echocardiographic and clinical outcomes from the CLASP IID Registry. METHODS: Patients with 3+ or 4+ DMR who were at prohibitive surgical risk, had complex mitral valve anatomy based on the MitraClip Instructions for Use, and deemed suitable for treatment with the PASCAL system were enrolled prospectively. Safety, clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. Study oversight included a central screening committee, echocardiographic core laboratory, and clinical events committee. RESULTS: Ninety-eight patients were enrolled. One-year Kaplan-Meier (KM) estimates of freedom from composite major adverse events, all-cause mortality, and heart failure hospitalization were 83.5%, 89.3%, and 91.5%, respectively. Significant mitral regurgitation (MR) reduction was achieved at 1 year (P < 0.001 vs baseline) including 93.2% at MR ≤2+ and 57.6% at MR ≤1+ with improvements in related echocardiographic measures. NYHA functional class and Kansas City Cardiomyopathy Questionnaire score also improved significantly (P < 0.001 vs baseline). CONCLUSIONS: At 1 year, treatment with the PASCAL system demonstrated safety and significant MR reduction, with continued improvement in clinical, echocardiographic, functional, and quality-of-life outcomes, illustrating the value of the PASCAL system in the treatment of prohibitive surgical risk patients with 3+ or 4+ DMR and complex mitral valve anatomy.

Exploring experiences associated with aortic stenosis diagnosis, treatment and life impact among middle-aged and older adults.

BACKGROUND AND PURPOSE: Although multiple studies have examined the clinical aspects of diagnosis, treatment, and management of patients with aortic stenosis (AS), limited data exist regarding patient experiences related to symptoms, diagnosis, treatment, and personal impacts of living with AS. METHODOLOGY: Adults aged ≥40 years diagnosed with AS were recruited and separated into three cohorts: medically managed, surgical aortic valve replacement (SAVR), and transcatheter aortic valve implantation (TAVI). Forty-five semi-structured interviews were conducted (15 per treatment group) via teleconference using open-ended questions and probes. Interview recordings were transcribed, and inductive thematic analyses were conducted. RESULTS: The majority of participants were male (55.6%), White (95.6%), and non-Hispanic (93.3%). Participants noting longer times to diagnosis also reported mild symptom onset and experiences of misdiagnoses. Participants described a strong reliance on their health care professionals (HCPs) to guide them through their treatment decisions, which were influenced by the effects of anticoagulation, future valve interventions, and recovery. Medically managed participants reported having to make lifestyle modifications to manage symptoms, while participants who underwent TAVI or SAVR reported positive sentiments in their ability to return to normal life following their treatment. CONCLUSIONS AND IMPLICATIONS: Due to the varied experiences of AS patients, there is a need to improve patient resources to advance patient understanding and facilitate informed treatment decisions. Reported experiences also indicate a need for additional HCP education on early referral to a multidisciplinary heart valve team.

Impact of concomitant aortic stenosis on the management and outcomes of acute myocardial infarction hospitalizations in the United States.

Objective: To evaluate the prevalence, management and outcomes of concomitant aortic stenosis (AS) in admissions with acute myocardial infarction (AMI). Methods: We used the HCUP-NIS database (2000-2017) to identify adult AMI admissions with concomitant AS. Outcomes of interest included prevalence of AS, in-hospital mortality, use of cardiac procedures, hospitalization costs, length of stay, and discharge disposition. Results: Among a total of 11,622,528 AMI admissions, 513,688 (4.4 %) were identified with concomitant AS. Adjusted temporal trends revealed an increase in STEMI and NSTEMI hospitalizations with concomitant AS. Compared to admissions without AS, those with AS were on average older, of female sex, had higher comorbidity, higher rates of NSTEMI (78.9 % vs 62.1 %), acute non-cardiac organ failure, and cardiogenic shock. Concomitant AS was associated with significantly lower use of coronary angiography (45.5 % vs 64.4 %), percutaneous coronary intervention (20.1 % vs 42.5 %), coronary atherectomy (1.7 % vs. 2.8 %) and mechanical circulatory support (3.5 % vs 4.8 %) (all p < 0.001). Admissions with AS had higher rates of coronary artery bypass surgery and surgical aortic valve replacement (5.9 % vs 0.1 %) compared to those without AS. Admissions with AMI and AS had higher in-hospital mortality (9.2 % vs. 6.0 %; adjusted OR 1.12 [95 % CI 1.10-1.13]; p <0.001). Concomitant AS was associated with longer hospital stay, more frequent palliative care consultations and less frequent discharges to home. Conclusions: In this 18-year study, an increase in prevalence of AS in AMI hospitalization was noted. Concomitant AS was associated with lower use of guideline-directed therapies and worse clinical outcomes among AMI admissions.

Association Between Peripheral Versus Central Access for Alternative Access Transcatheter Aortic Valve Replacement and Mortality and Stroke: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

BACKGROUND: In some patients, the alternative access route for transcatheter aortic valve replacement (TAVR) is utilized because the conventional transfemoral approach is not felt to be either feasible or optimal. However, accurate prognostication of patient risks is not well established. This study examines the associations between peripheral (transsubclavian/transaxillary, and transcarotid) versus central access (transapical and transaortic) in alternative access TAVR and 30-day and 1-year end points of mortality and stroke for all valve platforms. METHODS: Using data from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry with linkage to Medicare claims, patients who underwent alternative access TAVR from June 1, 2015 to June 30, 2018 were identified. Adjusted and unadjusted Cox proportional hazards modeling were performed to determine the association between alternate access TAVR site and 30-day and 1-year end points of mortality and stroke. RESULTS: Of 7187 alternative access TAVR patients, 3725 (52%) had peripheral access and 3462 (48%) had central access. All-cause mortality was significantly lower in peripheral access versus central access group at in-hospital and 1 year (2.9% versus 6.3% and 20.3% versus 26.6%, respectively), but stroke rates were higher (5.0% versus 2.8% and 7.3% versus 5.5%, respectively; all P<0.001). These results persisted after 1-year adjustment (death adjusted hazard ratio, 0.72 [95% CI, 0.62-0.85] and stroke adjusted hazard ratio, 2.92 [95% CI, 2.21-3.85]). When broken down by individual subtypes, compared with transaxillary/subclavian access patients, transapical, and transaortic access patients had higher all-cause mortality but less stroke (P<0.05). CONCLUSIONS: In this real-world, contemporary, nationally representative benchmarking study of alternate access TAVR sites, peripheral access was associated with favorable mortality and morbidity outcomes compared with central access, at the expense of higher stroke. These findings may allow for accurate prognostication of risk for patient counseling and decision-making for the heart team with regard to alternative access TAVR.