Commissural Alignment and Coronary Access after Transcatheter Aortic Valve Replacement.

Transcatheter aortic valve implantation (TAVR) is the first therapeutic option for elderly patients with severe symptomatic aortic stenosis, and indications are steadily expanding to younger patients and subjects with lower surgical risk and longer life expectancy. Commissural alignment between native and transcatheter valves facilitates coronary access after TAVR and is thus considered a procedural goal, allowing long-term management of coronary artery disease. Moreover, commissural alignment may potentially have a positive impact on transvalvular hemodynamic and valve durability. This review focus on technical hints to achieve commissural alignment and current evidence for different transcatheter aortic valves.

The effect of transcatheter aortic valve implantation approaches on mortality.

OBJECTIVES: We aimed to evaluate the effect of transcatheter aortic valve implantation (TAVI) approaches on mortality and identify effect modifiers and predictors for mortality. BACKGROUND: Alternative access routes to transfemoral (TF) TAVI include the surgical intra-thoracic direct-aortic (DA) and transapical (TA) approach. TA TAVI has been associated with a higher mortality rate. We hypothesized that this is related to effect modifiers, in particular the left ventricular ejection fraction (LVEF). METHODS: This multicentre study derived its data from prospective registries. To adjust for confounders, we used propensity-score based, stabilized inverse probability weighted Cox regression models. RESULTS: In total, 5,910 patients underwent TAVI via TF (N = 4,072), DA (N = 524), and TA (N = 1,314) access. Compared to TF, 30-day mortality was increased among DA (HR 1.87, 95%CI 1.26-2.78, p = .002) and TA (HR 3.34, 95%CI 2.28-4.89, p < .001) cases. Compared to TF, 5-year mortality was increased among TA cases (HR 1.50, 95%CI 1.24-1.83, p < .001). None of the variables showed a significant interaction between the approaches and mortality. An impaired LVEF (≤35%) increased mortality in all approaches. CONCLUSIONS: The surgical intra-thoracic TA and DA TAVI are both associated with a higher 30-day mortality than TF TAVI. TA TAVI is associated with a higher 5-year mortality than TF TAVI. The DA approach may therefore have some advantages over the TA approach when TF access is not feasible.

Impact of early hospital discharge on clinical outcomes after transcatheter aortic valve implantation.

AIMS: Early discharge after transcatheter aortic valve implantation (TAVI) may potentially impact post-procedural safety of the patient. The study aim was to compare safety of TAVI in patients planned for fast track hospital stay with patients planned for standard hospital stay. METHODS AND RESULTS: All-comers patients undergoing transfemoral TAVI between 2011 and 2017 were allocated to two matched groups depending whether the procedure was performed before or after transition from standard to fast track course. Data on vital status and hospitalizations were obtained through national registries. Three hundred and nineteen matched pairs were eligible for analysis. The median length of post-procedural stay was 3 days (IQR: 2-4) for patients in the fast track group compared to 6 days (IQR: 4-8) in the standard approach group (p < .0001). There was no difference in all-cause mortality between groups at 30-day (1.3% vs. 1.9%, p = .52) or 90-day follow-up (2.9% vs. 4.1%, p = .42). There was no difference in the risk of new permanent pacemaker implantation (PPI) in pacemaker naïve patients between groups at 30-day (15.8% vs. 21.2%, p = .16) or 90-day follow-up (15.8% vs. 21.9%, p = .12). There was no difference in the rate of rehospitalization between groups between discharge and 90-day follow-up (2.09 per patient-year vs. 2.09 per patient-year, p = .99). CONCLUSIONS: Early discharge in an all-comers population undergoing transfemoral TAVI is safe with regards to all-cause mortality, need for PPI, and rehospitalization.

Clinical impact of conduction disturbances in transcatheter aortic valve replacement recipients: a systematic review and meta-analysis.

AIMS: The clinical impact of new-onset persistent left bundle branch block (NOP-LBBB) and permanent pacemaker implantation (PPI) on transcatheter aortic valve replacement (TAVR) recipients remains controversial. We aimed to evaluate the impact of (i) periprocedural NOP-LBBB and PPI post-TAVR on 1-year all-cause death, cardiac death, and heart failure hospitalization and (ii) NOP-LBBB on the need for PPI at 1-year follow-up. METHODS AND RESULTS: We performed a systematic search from PubMed and EMBASE databases for studies reporting raw data on 1-year clinical impact of NOP-LBBB or periprocedural PPI post-TAVR. Data from 30 studies, including 7792 patients (12 studies) and 42 927 patients (21 studies) for the evaluation of the impact of NOP-LBBB and PPI after TAVR were sourced, respectively. NOP-LBBB was associated with an increased risk of all-cause death [risk ratio (RR) 1.32, 95% confidence interval (CI) 1.17-1.49; P < 0.001], cardiac death (RR 1.46, 95% CI 1.20-1.78; P < 0.001), heart failure hospitalization (RR 1.35, 95% CI 1.05-1.72; P = 0.02), and PPI (RR 1.89, 95% CI 1.58-2.27; P < 0.001) at 1-year follow-up. Periprocedural PPI after TAVR was associated with a higher risk of all-cause death (RR 1.17, 95% CI 1.11-1.25; P < 0.001) and heart failure hospitalization (RR 1.18, 95% CI 1.03-1.36; P = 0.02). Permanent pacemaker implantation was not associated with an increased risk of cardiac death (RR 0.84, 95% CI 0.67-1.05; P = 0.13). CONCLUSION: NOP-LBBB and PPI after TAVR are associated with an increased risk of all-cause death and heart failure hospitalization at 1-year follow-up. Periprocedural NOP-LBBB also increased the risk of cardiac death and PPI within the year following the procedure. Further studies are urgently warranted to enhance preventive measures and optimize the management of conduction disturbances post-TAVR.

Transcatheter Bioprosthetic Aortic Valve Dysfunction: What We Know So Far.

Transcatheter aortic valve replacement (TAVR) is an established alternative to surgical valve replacement for patients with severe aortic stenosis (AS) and increased surgical risk. On the basis of the favorable outcomes of recent randomized clinical trials conducted in intermediate and low risk populations, TAVR is expected in the near future to be offered to patients not only at lower surgical risk, but also with longer life expectancy. In this particular subset, the long-term durability of the bioprosthetic valve is of critical importance. The European Association of Percutaneous Cardiovascular Interventions (EAPCI), the European Society of Cardiology (ESC), and the European Association for Cardio-Thoracic Surgery (EACTS) recently introduced standardized criteria to define structural valve deterioration (SVD) and valve failure of transcatheter and surgical aortic bioprosthesis-this with the aim to generate uniformity in data reporting in future studies assessing long-term durability of aortic bioprosthesis. On this background, the aim of this article is to review the definition, incidence and predictors of transcatheter bioprosthetic valve dysfunction, including structural and non-structural valve deterioration (SVD/NSVD), valve thrombosis, and endocarditis.

Cost-effectiveness of transcatheter versus surgical aortic valve replacement in patients at lower surgical risk: results from the NOTION trial.

AIMS: The aim of this study was to estimate the cost-effectiveness of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) in patients at lower surgical risk. METHODS AND RESULTS: Discounted costs from a societal perspective and effectiveness as quality-adjusted life years (QALYs) were projected to lifetime via a decision-analytic model calibrated to 60-month data from the NOTION trial. The base case assumed a scenario in which any mortality benefit would gradually fade out over time, with other scenarios explored in sensitivity analyses. The incremental cost-effectiveness ratio (ICER) was compared to the country-specific willingness-to-pay (WTP) threshold of 1.13 million Danish kroner (DKK). The base case ICER was DKK 696,264/QALY (around €72,100/QALY via purchasing parity adjustment). Variation in long-term mortality beyond five years led to limited variation of incremental costs (DKK 64,200 to 64,600), but a more pronounced variation in incremental QALYs (0.07 to 0.19 QALYs for most conservative and optimistic assumptions, compared to base case of 0.09 QALYs). All resulting ICERs (range DKK 334,200 to DKK 904,100 per QALY gained) were below the WTP threshold. CONCLUSIONS: TAVI in a cohort of primarily low surgical risk patients was found to be a cost-effective treatment strategy in the Danish healthcare system. Cost-effectiveness analyses in other settings are warranted as are registries given the sensitivity of the model to long-term mortality.

Durability of Transcatheter and Surgical Bioprosthetic Aortic Valves in Patients at Lower Surgical Risk.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis and intermediate or high surgical risk. OBJECTIVES: The aim of this study was to compare the durability of transcatheter and surgical bioprosthetic aortic valves using standardized criteria. METHODS: In the NOTION (Nordic Aortic Valve Intervention) trial, all-comer patients with severe aortic stenosis and lower surgical risk for mortality were randomized 1:1 to TAVR (n = 139) or SAVR (n = 135). Moderate/severe structural valve deterioration (SVD) was defined as a mean gradient ≥20 mm Hg, an increase in mean gradient ≥10 mm Hg from 3 months post-procedure, or more than mild intraprosthetic aortic regurgitation (AR) either new or worsening from 3 months post-procedure. Nonstructural valve deterioration (NSVD) was defined as moderate/severe patient-prosthesis mismatch at 3 months or moderate/severe paravalvular leakage. Bioprosthetic valve failure (BVF) was defined as: valve-related death, aortic valve reintervention, or severe hemodynamic SVD. RESULTS: At 6 years, the rates of all-cause mortality were similar for TAVR (42.5%) and SAVR (37.7%) patients (p = 0.58). The rate of SVD was higher for SAVR than TAVR (24.0% vs. 4.8%; p < 0.001), whereas there were no differences in NSVD (57.8% vs. 54.0%; p = 0.52) or endocarditis (5.9% vs. 5.8%; p = 0.95). BVF rates were similar after SAVR and TAVR through 6 years (6.7% vs. 7.5%; p = 0.89). CONCLUSIONS: In the NOTION trial through 6 years, SVD was significantly greater for SAVR than TAVR, whereas BVF was low and similar for both groups. Longer-term follow-up of randomized clinical trials will be necessary to confirm these findings. (Nordic Aortic Valve Intervention Trial; NCT01057173).

Mortality and Heart Failure Hospitalization in Patients With Conduction Abnormalities After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to assess mortality and rehospitalization in patients with new bundle branch block (BBB) and/or permanent pacemaker (PPM) after transcatheter aortic valve replacement (TAVR). BACKGROUND: Previous studies have provided inconsistent results on the clinical impact of new BBB or new PPM after TAVR. METHODS: A total of 816 consecutive patients without pre-procedural BBB or PPM undergoing TAVR between 2007 and 2017 were followed for 5 years or until data extraction in September 2017. Data on vital status and hospitalization were obtained through national registries. RESULTS: Within 30 days post-TAVR, new BBB without PPM and new PPM occurred in 247 (30.3%) and 132 (16.2%) patients, respectively, leaving 437 patients (53.6%) without conduction abnormalities. Median follow-up was 2.5 years (interquartile range: 1.0 to 4.9 years). One-year all-cause mortality was increased for new BBB (hazard ratio [HR]: 2.80; 95% confidence interval [CI]: 1.18 to 3.67) but not for new PPM (HR: 1.64; 95% CI: 0.72 to 3.74) compared with patients with no conduction abnormalities. The risk for late all-cause mortality (≥1 year after TAVR) was higher both for patients with new BBB (HR: 1.79; 95% CI: 1.24 to 2.59) and for those with new PPM (HR: 1.58; 95% CI: 1.01 to 2.46) compared with patients with no conduction abnormalities. Patients with new BBB (HR: 1.47; 95% CI: 1.02 to 2.12) and new PPM (HR: 1.66; 95% CI: 1.09 to 2.54) had a higher risk for heart failure hospitalization and reduced left ventricular ejection fraction (p < 0.0001 for both groups) during follow-up. CONCLUSIONS: New BBB and new PPM developed frequently after TAVR. New BBB was associated with increased early and late all-cause mortality, whereas new PPM was associated with late all-cause mortality. Furthermore, both new BBB and new PPM increased the risk for heart failure hospitalizations.

Immediate Post-Procedural 12-Lead Electrocardiography as Predictor of Late Conduction Defects After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to use a 12-lead electrocardiogram obtained immediately post-transcatheter aortic valve replacement (TAVR) to identify predictors of late high-degree conduction defect (HD-CD) within 30 days after TAVR. BACKGROUND: There are limited data on risk factors for the development of late HD-CD and the need to retain the temporary pacemaker after TAVR. METHODS: A single-center study was conducted including 467 consecutive patients, without pre-procedural pacemakers, undergoing TAVR. RESULTS: Self-expandable, mechanical, or balloon-expandable heart valves were implanted in 328 (70%), 61 (13%), and 78 (17%) patients, respectively. For patients in sinus rhythm without right bundle branch block, late HD-CD developed in 0 of 70 patients (0%; 95% confidence interval [CI]: 0% to 5.1%) with PR interval <200 ms and QRS interval <120 ms and in 5 of 109 patients (4.6%; 95% CI: 1.5% to 10.4%; all with sufficient escape rhythm) with PR interval <240 ms and QRS interval <150 ms. Late HD-CD developed in 14 of 101 patients (13.9%; 95% CI: 7.8% to 22.2%; 6 with insufficient escape rhythm [5.9%; 95% CI: 2.2% to 12.5%]) with PR interval ≥240 ms or QRS interval ≥150 ms. Furthermore, late HD-CD developed in 3 of 49 patients (6.1%; 95% CI: 1.3% to 16.9%; all with sufficient escape rhythm) and in 3 of 30 patients (10.0%; 95% CI: 2.1% to 26.5%; 2 with insufficient escape rhythm [6.7%; 95% CI: 0.8% to 22.1%]) with atrial fibrillation and no right bundle branch block with QRS interval <140 and ≥140 ms, respectively. CONCLUSIONS: On the basis of immediate post-TAVR 12-lead electrocardiography, removing the temporary pacemaker immediately following TAVR is potentially safe in patients without right bundle branch block who are: 1) in sinus rhythm with PR interval <240 ms and QRS interval <150 ms; or 2) in atrial fibrillation with a QRS interval <140 ms.

Denmark: coronary and structural heart interventions from 2010 to 2015.

Interventional cardiology in Denmark has been carried out since the mid 1980s. Interventional cardiology is only performed at a few high-volume centres. Healthcare coverage is universal and is essentially free of charge. Hospitals are mostly publicly owned and financed by fixed budgets and, in part, an activity-based funding system. Approximately 30,000 coronary angiographies (CAG), 10,000 percutaneous coronary interventions (PCIs) of which approximately 25% are primary PCIs, and 500 transcatheter aortic valve implantations (TAVIs) are carried out each year. The numbers of CAG and PCI have reached a plateau in recent years, whereas structural heart interventions, in particular TAVI, are increasing. Around 90% of all patients treated with PCI have a stent implanted, with more than 95% of these being drug-eluting stents. There is a low but increasing use of bioabsorbable scaffolds and drug-eluting balloons.

Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses: Results From an International Registry Study.

OBJECTIVES: The aim of this study was to evaluate the use of transcatheter heart valves (THV) for the treatment of noncalcific pure native aortic valve regurgitation (NAVR) and failing bioprosthetic surgical heart valves (SHVs) with pure severe aortic regurgitation (AR). BACKGROUND: Limited data are available about the "off-label" use of transcatheter aortic valve replacement (TAVR) to treat pure severe AR. METHODS: The study population consisted of patients with pure severe AR treated by TAVR at 18 different centers. Study endpoints were device success, early safety, and clinical efficacy at 30 days, as defined by Valve Academic Research Consortium 2 criteria. RESULTS: A total of 146 patients were included, 78 patients in the NAVR group and 68 patients in the failing SHV group. In the NAVR group, device success, early safety, and clinical efficacy were 72%, 66%, and 61%, respectively. Device success and clinical efficacy were significantly better with newer generation THVs compared with old-generation THVs (85% vs. 54% and 75% vs. 46%, respectively, p < 0.05); this was mainly due to less second THV implantations and a lower rate of moderate to severe paravalvular regurgitation (10% vs. 24% and 3% vs. 27%, respectively). Independent predictors of 30-day mortality were body mass index <20 kg/m2, STS surgical risk score >8%, major vascular or access complication, and moderate to severe AR. In the failing SHV group, device success, early safety, and clinical efficacy were 71%, 90%, and 77%, respectively. CONCLUSIONS: TAVR for pure NAVR remains a challenging condition, with old-generation THVs being associated with THV embolization and migration and significant paravalvular regurgitation. Newer generation THVs show more promising outcomes. For those patients with severe AR due to failing SHVs, TAVR is a valuable therapeutic option.

Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study.

BACKGROUND: Subclinical leaflet thrombosis of bioprosthetic aortic valves after transcatheter valve replacement (TAVR) and surgical aortic valve replacement (SAVR) has been found with CT imaging. The objective of this study was to report the prevalence of subclinical leaflet thrombosis in surgical and transcatheter aortic valves and the effect of novel oral anticoagulants (NOACs) on the subclinical leaflet thrombosis and subsequent valve haemodynamics and clinical outcomes on the basis of two registries of patients who had CT imaging done after TAVR or SAVR. METHODS: Patients enrolled between Dec 22, 2014, and Jan 18, 2017, in the RESOLVE registry, and between June 2, 2014, and Sept 28, 2016, in the SAVORY registry, had CT imaging done with a dedicated four-dimensional volume-rendered imaging protocol at varying intervals after TAVR and SAVR. We defined subclinical leaflet thrombosis as the presence of reduced leaflet motion, along with corresponding hypoattenuating lesions shown with CT. We collected data for baseline demographics, antithrombotic therapy, and clinical outcomes. We analysed all CT scans, echocardiograms, and neurological events in a masked fashion. FINDINGS: Of the 931 patients who had CT imaging done (657 [71%] in the RESOLVE registry and 274 [29%] in the SAVORY registry), 890 [96%] had interpretable CT scans (626 [70%] in the RESOLVE registry and 264 [30%] in the SAVORY registry). 106 (12%) of 890 patients had subclinical leaflet thrombosis, including five (4%) of 138 with thrombosis of surgical valves versus 101 (13%) of 752 with thrombosis of transcatheter valves (p=0·001). The median time from aortic valve replacement to CT for the entire cohort was 83 days (IQR 33-281). Subclinical leaflet thrombosis was less frequent among patients receiving anticoagulants (eight [4%] of 224) than among those receiving dual antiplatelet therapy (31 [15%] of 208; p<0·0001); NOACs were equally as effective as warfarin (three [3%] of 107 vs five [4%] of 117; p=0·72). Subclinical leaflet thrombosis resolved in 36 (100%) of 36 patients (warfarin 24 [67%]; NOACs 12 [33%]) receiving anticoagulants, whereas it persisted in 20 (91%) of 22 patients not receiving anticoagulants (p<0·0001). A greater proportion of patients with subclinical leaflet thrombosis had aortic valve gradients of more than 20 mm Hg and increases in aortic valve gradients of more than 10 mm Hg (12 [14%] of 88) than did those with normal leaflet motion (seven [1%] of 632; p<0·0001). Although stroke rates were not different between those with (4·12 strokes per 100 person-years) or without (1·92 strokes per 100 person-years) reduced leaflet motion (p=0·10), subclinical leaflet thrombosis was associated with increased rates of transient ischaemic attacks (TIAs; 4·18 TIAs per 100 person-years vs 0·60 TIAs per 100 person-years; p=0·0005) and all strokes or TIAs (7·85 vs 2·36 per 100 person-years; p=0·001). INTERPRETATION: Subclinical leaflet thrombosis occurred frequently in bioprosthetic aortic valves, more commonly in transcatheter than in surgical valves. Anticoagulation (both NOACs and warfarin), but not dual antiplatelet therapy, was effective in prevention or treatment of subclinical leaflet thrombosis. Subclinical leaflet thrombosis was associated with increased rates of TIAs and strokes or TIAs. Despite excellent outcomes after TAVR with the new-generation valves, prevention and treatment of subclinical leaflet thrombosis might offer a potential opportunity for further improvement in valve haemodynamics and clinical outcomes. FUNDING: RESOLVE (Cedars-Sinai Heart Institute) and SAVORY (Rigshospitalet).

Efficacy and safety of the Lotus Valve System for treatment of patients with severe aortic valve stenosis and intermediate surgical risk: Results from the Nordic Lotus-TAVR registry.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become an established therapeutic option for patients with symptomatic, severe aortic valve stenosis (AS) who are ineligible or at high risk for conventional valvular surgery. In Northwestern Europe, the TAVR technology is also increasingly used to treat patients with an intermediate risk profile. METHODS AND RESULTS: The study was designed as an independent Nordic multicenter registry of intermediate risk patients treated with the Lotus Valve System (Boston Scientific, MA, USA; N=154). Valve Academic Research Consortium (VARC)-defined device success was obtained in 97.4%. A Lotus Valve was successfully implanted in all patients. There was no valve migration, embolization, ectopic valve deployment, or TAV-in-TAV deployment. The VARC-defined combined safety rate at 30days was 92.2%, with a mortality rate of 1.9% and stroke rate of 3.2%. The clinical efficacy rate after 30days was 91.6% - only one patient had moderate aortic regurgitation. When considering only those patients in the late experience group (N=79), the combined safety and clinical efficacy rates were 93.7% and 92.4%, respectively. The pacemaker implantation rate was 27.9% - this rate was 12.8% in case of a combined implantation depth <4mm and a device/annulus ratio<1.05. CONCLUSIONS: The present study demonstrates the efficacy and safety of the repositionable, retrievable Lotus Valve System in intermediate risk patients with AS. The VARC-defined device success rate was 97.4% with a 30-day patient safety and clinical efficacy rate of more than 90%. Less than moderate aortic regurgitation was obtained in 99.4% of patients.