Impact of first-phase ejection fraction on clinical outcomes in patients undergoing transcatheter aortic valve implantation.

BACKGROUND First-phase left ventricular ejection fraction (LVEF1) is an early marker of left ventricular remodeling. Reduced LVEF1 has been associated with adverse prognosis in patients with aortic stenosis (AS) and preserved left ventricular ejection fraction (LVEF). It remains to be determined, whether reduced LVEF1 differentiates clinical outcomes after aortic valve replacement. OBJECTIVES We investigated the impact of LVEF1 on clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) for symptomatic severe AS with preserved LVEF (≥ 50%). METHODS In the prospective Bern TAVI registry, we retrospectively categorized patients according to LVEF1 as assessed by transthoracic echocardiography. Clinical outcomes of interest were all-cause mortality and residual heart failure symptoms (New York Heart Association (NYHA) functional class III or IV) at 1 year after TAVI. RESULTS A total of 644 patients undergoing TAVI between January 2014 and December 2019 were included in the present analysis. Patients with low LVEF1 had a lower LVEF (62.0 ± 6.89% vs. 64.3 ± 7.82%, P < 0.001) and a higher left ventricular mass index (129.3 ± 39.1 g/m2 vs. 121.5 ± 38.0 g/m2; P = 0.027) compared to patients with high LVEF1. At 1 year, the incidence of all-cause/cardiovascular death, and NYHA III or IV were comparable between patients with low and high LVEF1 (8.3% vs. 9.2%; P = 0.773, 3.9% vs. 6.0%; P = 0.276, 12.9% vs. 12.2%; P = 0.892, respectively). CONCLUSIONS Reduced LVEF1 was not associated with adverse clinical outcomes following TAVI in patients with symptomatic severe AS with preserved LVEF. CLINICAL TRIAL REGISTRATION https://www. CLINICALTRIALS gov. NCT01368250

Imaging of Bioprosthetic Valve Dysfunction after Transcatheter Aortic Valve Implantation.

Transcatheter aortic valve implantation (TAVI) has become the standard of care in elderly high-risk patients with symptomatic severe aortic stenosis. Recently, TAVI has been increasingly performed in younger-, intermediate- and lower-risk populations, which underlines the need to investigate the long-term durability of bioprosthetic aortic valves. However, diagnosing bioprosthetic valve dysfunction after TAVI is challenging and only limited evidence-based criteria exist to guide therapy. Bioprosthetic valve dysfunction encompasses structural valve deterioration (SVD) resulting from degenerative changes in the valve structure and function, non-SVD resulting from intrinsic paravalvular regurgitation or patient-prosthesis mismatch, valve thrombosis, and infective endocarditis. Overlapping phenotypes, confluent pathologies, and their shared end-stage bioprosthetic valve failure complicate the differentiation of these entities. In this review, we focus on the contemporary and future roles, advantages, and limitations of imaging modalities such as echocardiography, cardiac computed tomography angiography, cardiac magnetic resonance imaging, and positron emission tomography to monitor the integrity of transcatheter heart valves

Transcatheter aortic valve implantation in patients with rheumatic aortic stenosis.

BACKGROUND Rheumatic heart disease (RHD) accounts for the highest number of deaths from valvular heart disease globally. Yet, rheumatic aortic stenosis (AS) was excluded from landmark studies investigating the safety and efficacy of transcatheter aortic valve implantation (TAVI). We aimed to describe the clinical and anatomical characteristics of patients with rheumatic AS undergoing TAVI, and to compare procedural and clinical outcomes with patients undergoing TAVI for degenerative AS. METHODS In a prospective TAVI registry, patients with rheumatic AS were identified based on International Classification of Diseases version 10 codes and/or a documented history of acute rheumatic fever and/or the World Heart Federation criteria for echocardiographic diagnosis of RHD, and were propensity score-matched in a 1:4 ratio to patients with degenerative AS. RESULTS Among 2329 patients undergoing TAVI, 105 (4.5%) had rheumatic AS. Compared with patients with degenerative AS, patients with rheumatic AS were more commonly female, older, had higher surgical risk and more commonly suffered from multivalvular heart disease. In the unmatched cohort, both technical success (85.7% vs 85.9%, p=0.887) and 1-year cardiovascular mortality (10.0% vs 8.6%; HR 1.16, 95% CI 0.61 to 2.18, p=0.656) were comparable between patients with rheumatic and degenerative AS. In contrast, patients with rheumatic AS had lower rates of 30-day and 1-year cardiovascular mortality compared with matched patients with degenerative AS (1.9% vs 8.9%, adjusted HR (HRadj) 0.18, 95% CI 0.04 to 0.80, p=0.024; and 10.0% vs 20.3%, HRadj 0.44, 95% CI 0.24 to 0.84, p=0.012, respectively). CONCLUSION TAVI may be a safe and effective treatment strategy for selected elderly patients with rheumatic AS. TRIAL REGISTRATION NUMBER NCT01368250

Diagnostic performance of quantitative coronary artery disease assessment using computed tomography in patients with aortic stenosis undergoing transcatheter aortic-valve implantation.

BACKGROUND Computed tomography angiography (CTA) is a cornerstone in the pre- transcatheter aortic valve replacement (TAVI) assessment. We evaluated the diagnostic performance of CTA and coronary artery calcium score (CACS) for CAD evaluation compared to invasive coronary angiography in a cohort of TAVI patients. METHODS In consecutive TAVI patients without prior coronary revascularization and device implants, CAD was assessment by quantitative analysis in CTA. (a) Patients with non-evaluable segments were classified as obstructive CAD. (b) In patients with non-evaluable segments a CACS cut-off of 100 was applied for obstructive CAD. The reference standard was quantitative invasive coronary angiography (QCA, i.e. ≥ 50% stenosis). RESULTS 100 consecutive patients were retrospectively included, age was 82.3 ± 6.5 years and 30% of patients had CAD. In 16% of the patients, adequate visualization of the entire coronary tree (all 16 segments) was possible with CTA, while 84% had at least one segment which was not evaluable for CAD analysis due to impaired image quality. On a per-patient analysis, where patients with low image quality were classified as CAD, CTA showed a sensitivity of 100% (95% CI 88.4-100.0), specificity of 11.4% (95% CI 5.1-21.3), PPV of 32.6% (95% CI 30.8-34.5), NPV of 100% and diagnostic accuracy of 38% (95% CI 28.5-48.3) for obstructive CAD. When applying a combined approach of CTA (in patients with good image quality) and CACS (in patients with low image quality), the sensitivity and NPV remained at 100% and obstructive CAD could be ruled out in 20% of the TAVI patients, versus 8% using CTA alone. CONCLUSION In routinely acquired pre-TAVI CTA, the image quality was insufficient in a high proportion of patients for the assessment of the entire coronary artery tree. However, when adding CACS in patients with low image quality to quantitative CTA assessment in patients with good image quality, obstructive CAD could be ruled-out in 1/5 of the patients and may therefore constitute a strategy to streamline pre-procedural workup, and reduce risk, radiation and costs in selected TAVI patients without prior coronary revascularization or device implants

Transcatheter Aortic Valve Replacement in Patients With Multivalvular Heart Disease.

As transcatheter aortic valve replacement becomes a more dominant treatment option across all risk profiles, the frequency of encountering patients with multivalvular disease will increase. Furthermore, percutaneous interventions to treat other valvular lesions are also evolving. Understanding the clinical implications and treatment options for a second valvular lesion is becoming increasingly important to guide heart team decisions, and this paper aims to review the evidence around these situations. Diagnosis of multivalvular disease can be challenging because of changes in physiology. There are little randomized data to guide therapy in multivalvular disease. Multidisciplinary heart team decisions can be invaluable in integrating the plethora of clinical, hemodynamic, and imaging data on which an optimal management strategy can be planned. Prospective studies to assess the role of structural valve interventions in the transcatheter aortic valve replacement era would greatly help improve outcomes for structural heart patients

Refined Staging Classification of Cardiac Damage Associated with Aortic Stenosis and Outcomes after Transcatheter Aortic Valve Implantation

Aims A new staging classification of aortic stenosis (AS) characterizing the extent of cardiac damage was established and validated in patients undergoing transcatheter aortic valve implantation (TAVI). We aimed to validate an updated classification system in patients undergoing TAVI. Methods and Results In a prospective TAVI registry, AS patients were categorized into the following stages: no cardiac damage (Stage 0), left ventricular damage (Stage 1), left atrial or mitral valve damage (Stage 2), pulmonary vasculature or tricuspid valve damage (Stage 3), or right ventricular (RV) damage or low-flow state (Stage 4). Stage 3 was sub-divided into Stage 3a (≤moderate pulmonary hypertension) and Stage 3b (severe pulmonary hypertension). Stage 4 was sub-divided into Stage 4a (low-flow without RV dysfunction), Stage 4b (RV dysfunction without low-flow), and Stage 4c (RV dysfunction with low-flow). The primary endpoint was all-cause death at 1 year. Among 1,156 eligible patients, 14 were classified as Stage 0, 38 as Stage 1, 105 as Stage 2, 278 as Stage 3, and 721 as Stage 4. There was a stepwise increase in mortality according to advancing stages of cardiac damage: 3.9% (Stage 0-1), 9.6% (Stage 2), 14.1% (Stage 3), and 17.4% (Stage 4) (p = 0.002). After multivariable adjustment, only Stage 3b, Stage 4b, and Stage 4c conferred a significantly increased risk of mortality compared to Stage 0-1. Conclusion More than one third of patients had advanced cardiac damage (severe pulmonary hypertension or RV dysfunction) before TAVI, associating with a 5- to 7-fold increased risk of mortality at 1 year

Impact of Left Ventricular Outflow Tract Calcification on Procedural Outcomes After Transcatheter Aortic Valve Replacement.

OBJECTIVES This study aimed to systematically assess the importance of left ventricular outflow tract (LVOT) calcification on procedural outcomes and device performances with contemporary transcatheter heart valve (THV) systems. BACKGROUND LVOT calcification has been associated with adverse clinical outcomes after transcatheter aortic valve replacement (TAVR). However, the available evidence is limited to observational data with modest numbers and incomplete assessment of the effect of the different THV systems. METHODS In a retrospective analysis of a prospective single-center registry, LVOT calcification was assessed in a semiquantitative fashion. Moderate or severe LVOT calcification was documented in the presence of 2 nodules of calcification, or 1 extending >5 mm in any direction, or covering >10 % of the perimeter of the LVOT. RESULTS Among 1,635 patients undergoing TAVR between 2007 and 2018, moderate or severe LVOT calcification was found in 407 (24.9%). Patients with moderate or severe LVOT calcification had significantly higher incidences of annular rupture (2.3% vs. 0.2%; p < 0.001), bailout valve-in-valve implantation (2.9% vs. 0.8%; p = 0.004), and residual aortic regurgitation (11.1% vs. 6.3%; p = 0.002). Balloon-expandable valves conferred a higher risk of annular rupture in the presence of moderate or severe LVOT calcification (4.0% vs. 0.4%; p = 0.002) as compared with the other valve designs. There was no significant interaction of valve design or generation and LVOT calcification with regard to the occurrence of bailout valve-in-valve implantation and residual aortic regurgitation. CONCLUSIONS Moderate or severe LVOT calcification confers increased risks of annular rupture, residual aortic regurgitation, and implantation of a second valve. The risk of residual aortic regurgitation is consistent across valve designs and generations. (SWISS TAVI Registry; NCT01368250)

Discharge Location and Outcomes after Transcatheter Aortic Valve Implantation.

The relationship between discharge location and outcomes after transcatheter aortic valve implantation (TAVI) is largely unknown. Thus, the objective of this study was to investigate the impact of discharge location on clinical outcomes after TAVI. Between August 2007 and December 2018, consecutive patients undergoing transfemoral TAVI at Bern University Hospital were grouped according to discharge location. Clinical adverse events were adjudicated according to VARC-2 endpoint definitions. Of 1,902 eligible patients, 520 (27.3%) were discharged home, 945 (49.7%) were discharged to a rehabilitation clinic and 437 (23.0%) were transferred to another institution. Compared with patients discharged to a rehabilitation facility or another institution, patients discharged home were younger (80.8±6.5 vs. 82.9±5.4 and 82.8±6.4 years), less likely female (37.3% vs. 59.7% and 54.2%) and at lower risk according to STS-PROM (4.5±3.0% vs. 5.5±3.8% and 6.6±4.4%). At 1 year follow-up, patients discharged home had similar rates of all-cause mortality (HRadj 0.82; 95%CI 0.54-1.24), cerebrovascular events (HRadj 1.04; 95%CI 0.52-2.08) and bleeding complications (HRadj 0.93; 95%CI 0.61-1.41) compared to patients discharged to a rehabilitation facility. Patients discharged home or to rehabilitation were at lower risk for death (HRadj 0.37; 95%CI 0.24-0.56 and HRadj 0.44; 95%CI 0.32-0.60) and bleeding (HRadj 0.48; 95%CI 0.30-0.76 and HRadj 0.66; 95%CI 0.45-0.96) during the first year after hospital discharge compared to patients transferred to another institution. In conclusion, discharge location is associated with outcomes after TAVI with patients discharged home or to a rehabilitation facility having better clinical outcomes than patients transferred to another institution. Clinical Trial Registration: https://www.clinicaltrials.gov. NCT01368250

Valvular and Nonvalvular Atrial Fibrillation in Patients Undergoing Transcatheter Aortic Valve Replacement.

OBJECTIVES The aim of this study was to investigate the impact of valvular and nonvalvular atrial fibrillation (AF) in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND AF has been associated with adverse clinical outcomes after TAVR. However, the differential impact of valvular as opposed to nonvalvular AF has not been investigated. METHODS In a retrospective analysis of a prospective registry, valvular AF was defined as AF in the setting of concomitant mitral stenosis or the presence of a mitral valve prosthesis. The presence of mitral stenosis was determined by pre-procedural echocardiography. The primary endpoint was a composite of cardiovascular death or disabling stroke at 1 year after TAVR. RESULTS Among 1,472 patients undergoing TAVR between August 2007 and June 2018, AF was recorded in 465 patients (31.6%) and categorized as nonvalvular in 376 (25.5%) and valvular in 89 (6.0%). AF scores including HAS-BLED, CHADS2, and CHA2DS2-VASc were comparable between patients with nonvalvular and valvular AF. The primary endpoint occurred in 9.3% of patients with no AF, in 14.5% of patients with nonvalvular AF (hazard ratio: 1.57; 95% confidence interval: 1.12 to 2.20; p = 0.009), and in 24.2% of patients with valvular AF (hazard ratio: 2.75; 95% confidence interval: 1.71 to 4.41; p < 0.001). Valvular AF conferred an increased risk for cardiovascular death or disabling stroke compared with nonvalvular AF (hazard ratio: 1.77; 95% confidence interval: 1.07 to 2.94; p = 0.027). CONCLUSIONS The presence of valvular AF in patients undergoing TAVR increased the risk for cardiovascular death or disabling stroke compared with both no AF and nonvalvular AF. (SWISS TAVI Registry; NCT01368250)