Increased cardiovascular mortality in patients with mechanically expandable transcatheter aortic valve and without permanent pacemaker.

INTRODUCTION: Use of the mechanically expandable transcatheter aortic valve (MEV) has been recently linked to increased risks of valve dysfunction and cardiovascular mortality. The risk of developing conduction disturbance with the MEV valve is well known, and the negative prognostic impact of permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation is another consideration. AIM: This study aimed to compare the mid-term survival of patients with MEV and self-expandable valves (SEV), and to examine survival of both groups according to the presence or absence of PPI. METHODS: This single-centre, retrospective, observational study examined data from MEV and SEV groups comprising 92 and 373 patients, respectively. The mean clinical follow-up was 2.5±1.7 years. Mortality information was obtained from the National Institutes of Health Information and Statistics. RESULTS: Baseline characteristics were comparable between the groups. The log-rank test showed higher cardiovascular mortality in the MEV group (p=0.042; the relative risk (RR) 1.594 (95% CI 1.013 to 2.508)). The Cox proportional hazards model identified MEV implantation as an independent predictor of cardiovascular mortality. The rate of PPI was twice as high in the MEV vs SEV group (33.7% vs 16.1%; p<0.001). We compared the survival of both groups according to the presence or absence of PPI and found higher mortality in the MEV group without PPI versus the SEV group without PPI (p=0.007; RR 2.156 (95% CI 1.213 to 3.831)). Survival did not differ in the groups with PPI. CONCLUSIONS: A higher mid-term cardiovascular mortality rate was observed with MEV versus SEV implants. Comparing both groups according to the presence or absence of PPI, we observed a higher mortality risk in patients with MEV without PPI than in SEV without PPI. In contrast, mortality did not differ between the groups when PPI was implanted.

Mid-term outcomes of patients with Lotus and Evolut transcatheter valves.

Introduction: Long-term data on the Lotus® (Boston Scientific, USA) valve are lacking. Aim: To evaluate mid-term outcomes of aortic stenosis patients treated with either Lotus or Evolut R® valves (Medtronic, USA). Material and methods: Our study sample comprised 190 patients (71 Lotus and 119 Evolut valves). The mean clinical follow-up was 2.0 ±0.9 years. Information on mortality was obtained from the National Institutes of Health Information and Statistics. Results: No significant differences existed in baseline characteristics between the groups. The rate of procedural complications was low and without significant differences between groups. The log rank test showed higher mortality in the Lotus group for cardiovascular mortality (p = 0.02; RR = 2.4, 95% CI: 1.123-5.075). Multivariable analysis revealed that the Lotus valve was independently associated with cardiovascular mortality (p = 0.03). At the end of echocardiography follow-up (4.1 ±0.9 years), we found a significantly higher mean aortic valve gradient (AVGm) in the Lotus group than in the Evolut group (17.9 ±9.5 vs. 10.2 ±3.5 mm Hg; p = 0.0006), and 3 (10%) patients from the Lotus group suffered from symptomatic re-stenosis requiering re-intervention. Conclusions: The results of our study suggest that higher cardiovascular mortality rates during mid-term follow-up were associated with Lotus compared with Evolut valves. Higher AVGm in the Lotus valves suggests the possibility of accelerated prosthesis degeneration.

The impact of education as a marker of socio-economic status on survival of patients after transcatheter aortic valve implantation.

Introduction: An association exists between low socio-economic status (SES) and increased cardiovascular and all-cause mortality worldwide. Aim: To evaluate the impact of educational level as a marker of socio-economic status (SES) on the clinical condition of patients before transcatheter aortic valve implantation (TAVI) and survival after TAVI. Material and methods: We conducted a retrospective observational study involving patients with severe aortic stenosis (AS) who underwent TAVI. We divided patients based on their level of education into lower (LLE) and higher educational level (HLE) groups. We evaluated periprocedural (combined endpoints of device success (DS) and early safety (ES), according to VARC2 criteria) and mid-term outcomes (all-cause and cardiovascular mortality). Results: Of the 379 study patients, 212 were in the LLE group. The mean follow-up was 2.1 ±1.8 years. Patients with a LLE were younger (77.4 ±7.2 vs. 79.4 ±6.5 years, p = 0.006) and more often female (58% vs. 40%, p < 0.001). They had higher body mass index (29.5 ±5.7 vs. 28.3 ±4.8, p = 0.037), more often type 2 diabetes mellitus (43% vs. 31%, p = 0.013) and moderate or severe aortic regurgitation (8% vs. 2%, p = 0.026), and some patients' condition required urgent TAVI (5% vs. 0%, p = 0.003). There were no differences in combined procedural endpoints. The all-cause mortality during mid-term follow-up was 25% in the LLE group and 24% in the HLE group (log-rank, p = 0.941). Cardiovascular mortality was 19% in both groups (log-rank, p = 0.925). Conclusions: Patients with an LLE required TAVI at a younger age, had more comorbidities and had a more risky profile. Level of education did not influence periprocedural and mid-term outcomes.

Long-term survival of carotid stenting patients with regard to single- or double-vessel carotid artery disease: a propensity score matching analysis.

INTRODUCTION: There is lack of long-term data outside of controlled clinical trials in carotid artery stenting (CAS). In this study, we compared the short-term outcome, long-term survival, and rate of re-interventions for restenosis in patients after CAS, related to the extent of carotid atherosclerosis classified as single-vessel (unilateral) or double-vessel (bilateral) carotid artery disease. MATERIAL AND METHODS: We retrospectively evaluated 599 patients with significant carotid artery stenosis, who underwent 763 CAS procedures, and used the propensity score to match 226 pairs (452 patients) in the single- or double-vessel carotid disease. RESULTS: There was no significant difference in the occurrence of in-hospital major adverse events (3.5% vs. 3.1% of patients in the double-vessel carotid group vs. the single-vessel carotid group; p = 1) The mean follow-up was 6.1 ±4.0 years, and a total of 181 (40%) deaths occurred during 2759 patient-years, which translates into 7.8 and 5.3 deaths per 100 patient-years in the double-vessel carotid group and the single-vessel carotid group, respectively (p < 0.01). The survival in the double-vessel carotid group vs. the single-vessel carotid group at 10 years was 46% (95% CI: 38-54%) vs. 55% (95% CI: 47-63%) (p < 0.01). Twenty-four (11%) patients and 6 (3%) patients underwent re-interventions for restenosis in the double-vessel and the single-vessel carotid disease group, respectively (p < 0.01). CONCLUSIONS: Patients with CAS and significant double-vessel carotid artery disease had similar peri-procedural risk, but had a worse long-term survival, and a higher rate of re-interventions for restenosis compared to the single-vessel carotid artery disease patients.

Patients with hypertrophic obstructive cardiomyopathy after alcohol septal ablation have favorable long-term outcome irrespective of their genetic background.

BACKGROUND: The genetic background of patients with hypertrophic cardiomyopathy (HCM) treated with alcohol septal ablation (ASA) and its relationship to the outcomes are not known. We aimed to investigate whether the outcome of genotype positive (G+) patients differs from genotype negative (G-) patients treated with ASA. METHODS: We included 129 HCM patients (mean age 54±13 years) treated with ASA in a tertiary cardiovascular center and performed next generation sequencing (NGS) based genomic testing. All patients were followed-up three months after the procedure and yearly thereafter. RESULTS: A total of 30 (23%) HCM patients were G+ patients. At the 3-months follow-up, both groups of patients had similar left ventricular outflow tract PG (16.9±15.7 mmHg in G+ vs. 16.3±18.8 mmHg in G-, P=0.73) and symptoms (follow-up NYHA class 1.40±0.62 vs. 1.37±0.53, P=0.99, follow-up CCS class 0.23±0.52 vs. 0.36±0.65, P=0.36). The independent predictors of all-cause mortality were baseline interventricular septum (IVS) thickness (HR 1.12, 95% CI: 1.00-1.26, P=0.049) and age at the time of ASA (HR 1.11, 95% CI: 1.06-1.17, P<0.01). The adjusted all-cause mortality rate did not differ significantly between G+ and G- patients (P=0.52). The adjusted combined mortality event rate did not differ between both groups (P=0.78). CONCLUSIONS: Despite more severe phenotype in G+ HCM patients, ASA is an equally effective treatment for LVOTO in G+ patients as it is for treating LVOTO in G- patients. The long-term outcome after ASA is similar in G+ and G- patients.

Outcome of patients ≥ 60 years of age after alcohol septal ablation for hypertrophic obstructive cardiomyopathy.

INTRODUCTION: The outcome of patients ≥ 60 years of age after alcohol septal ablation (ASA) for obstructive hypertrophic cardiomyopathy (HCM) remains unresolved. We sought to determine the long-term survival and the causes of death in this population. MATERIAL AND METHODS: We enrolled 156 consecutive patients (69 ±6 years, 69% women, follow-up: 4.8 ±3.5 years) who underwent ASA at ≥ 60 years of age. RESULTS: The 30-day mortality rate was 1.3%. At the last check-up, 81% of patients were in New York Heart Association class ≤ 2 and 76% had a left ventricular outflow tract gradient (LVOG) ≤ 30 mm Hg. A total of 39 patients died (51% of cardiovascular causes, 44% of non-cardiovascular causes, 5% of unknown causes) during the 734 patient-years. The annual sudden mortality, the sudden mortality and the all-cause mortality rates were 0.5%, 1.1%, and 4.8%, respectively. The all-cause mortality was higher compared to the age- and sex-matched general population (p = 0.002). CONCLUSIONS: Alcohol septal ablation was safe and effective in the long-term follow-up. We observed a reduced life expectancy compared to the age- and sex-matched general population. Mortality was almost equally due to cardiovascular and non-cardiovascular causes of death.

Effect of impaired cardiac conduction after alcohol septal ablation on clinical outcomes: insights from the Euro-ASA registry.

AIMS: We analysed the impact of bundle branch block (BBB) and pacemaker (PM) implantation on symptoms and survival after alcohol septal ablation (ASA) in patients with hypertrophic cardiomyopathy (HCM). METHODS AND RESULTS: Among 1416 HCM patients from the Euro-ASA registry, 58 (4%) patients had a PM and 64 (5%) patients had an implantable cardioverter-defibrillator (ICD) before ASA. At latest follow-up (5.0 ± 4.0 years) after ASA, 118 (8%) patients had an ICD and 229 (16%) patients had a PM. In patients without an implantable device prior to ASA 13% had a PM and 5% had an ICD implanted following ASA. New onset BBB was present in 44% (right BBB in 31%) of patients without previous BBB. At latest follow-up, we found no associations between BBB and New York Heart Association (NYHA) Class 3-4 [odds ratio (OR) 0.98, 95% confidence interval (CI) 0.63-1.51; P = 0.91] or Canadian Cardiovascular Society (CCS) Class 3-4 (OR 1.5, CI 0.32-6.7; P = 0.62), respectively, and no associations between PM and NYHA Class 3-4 (OR 1.2, CI 0.70-2.0; P = 0.52) or CCS 3-4 (OR 1.3, CI 0.24-6.6; P = 0.79), respectively. The survival after ASA was not reduced in patients with BBB [hazard ratio (HR) 0.73, CI 0.53-1.01; P = 0.06] or PM (HR 0.78, CI 0.52-1.17; P = 0.24). CONCLUSIONS: Development of BBB or need for a PM after ASA in patients with obstructive HCM was not associated with inferior symptomatic outcome or reduced survival, thus concerns for the negative impact of impaired cardiac conduction on the clinical outcome after ASA were not confirmed.

Effect of Institutional Experience on Outcomes of Alcohol Septal Ablation for Hypertrophic Obstructive Cardiomyopathy.

BACKGROUND: The current American College of Cardiology Foundation/American Heart Association guidelines on hypertrophic cardiomyopathy state that institutional experience is a key determinant of successful outcomes and lower complication rates of alcohol septal ablation (ASA). The aim of this study was to evaluate the safety and efficacy of ASA according to institutional experience with the procedure. METHODS: We retrospectively evaluated 1310 patients with symptomatic obstructive hypertrophic cardiomyopathy who underwent ASA and were divided into 2 groups. The first-50 group consisted of the first consecutive 50 patients treated at each centre, and the over-50 group consisted of patients treated thereafter (patients 51 and above). RESULTS: In the 30-day follow-up, there was a significant difference in the occurrence of major cardiovascular adverse events (21% in the first-50 group vs 12% in the over-50 group; P < 0.01), which was driven by the occurrence of cardiovascular deaths (2.1% vs 0.4%; P = 0.01) and implanted pacemakers (15% vs 9%; P < 0.01). In the long-term follow-up (5.5 ± 4.1 years), the first-50 group was associated with a significantly higher occurrence of major adverse events (P < 0.01) and higher cardiovascular mortality (P < 0.01). Also, patients in the first-50 group were more likely to self-report dyspnea of New York Heart Association class III/IV (16% vs 10%), to have a left ventricular outflow gradient > 30 mm Hg (16% vs 10%) at the last clinical check-up (P < 0.01 for both), and a probability of repeated septal reduction therapy (P = 0.03). CONCLUSIONS: An institutional experience of > 50 ASA procedures was associated with a lower occurrence of ASA complications, better cardiovascular survival, better hemodynamic and clinical effect, and less need for repeated septal reduction therapy.

Validation of the HCM Risk-SCD model in patients with hypertrophic cardiomyopathy following alcohol septal ablation.

Aims: The HCM Risk-SCD model for prediction of sudden cardiac death (SCD) in hypertrophic cardiomyopathy recommended by the 2014 European Society of Cardiology (ESC) guidelines has not been validated after septal reduction therapy. The aim of this study was to validate the HCM Risk-SCD model in patients undergoing alcohol septal ablation (ASA) and to compare its performance to previous models. Methods and result: A total of 844 ASA patients without prior SCD event were included. The primary endpoint was a composite of SCD and appropriate implantable cardioverter defibrillator (ICD) therapy, identical to the HCM Risk-SCD endpoint. A distinction between periprocedural (≤30 days) and long-term (>30 days) SCD was made to discern procedure-related adverse arrhythmic events caused by the ASA-induced myocardial infarction from long-term SCD risk. Twenty patients reached the SCD endpoint within the first 30 days. During a follow-up of 6.5 ± 4.2 years, another 46 patients reached the SCD endpoint. The predicted 5-year SCD risk according to the HCM Risk-SCD model was 5.1%, and the observed 5-year SCD risk was 4.0%. The C-statistics for the use of the HCM Risk-SCD model was 0.61 (P = 0.02), the C-statistics for the use of the 2003 American College of Cardiology/ESC guidelines was 0.59 (P = 0.051), and the C-statistic for the use of the 2011 American College of Cardiology Foundation/American Heart Association guidelines was 0.58 (P = 0.054). Maximal left ventricular wall thickness, syncope after ASA, and fulfilling the 2014 ESC recommendations for primary ICD implantation according to the HCM Risk-SCD model, respectively, predicted SCD during long-term follow-up. Conclusion: The HCM Risk-SCD model can be used for SCD prediction in patients undergoing ASA.

Outcomes of Alcohol Septal Ablation in Younger Patients With Obstructive Hypertrophic Cardiomyopathy.

OBJECTIVES: The aim of this study was to describe the safety and outcomes of alcohol septal ablation (ASA) in younger patients with obstructive hypertrophic cardiomyopathy. BACKGROUND: The American College of Cardiology Foundation/American Heart Association guidelines reserve ASA for older patients and patients with serious comorbidities. Data on long-term age-specific outcomes after ASA are scarce. METHODS: A total of 1,197 patients (mean age 58 ± 14 years) underwent ASA for obstructive hypertrophic cardiomyopathy. Patients were divided into young (≤50 years), middle-age (51 to 64 years), and older (≥65 years) groups. RESULTS: Thirty-day mortality and pacemaker implantation rates were lower in young compared with older patients (0.3% vs. 2% [p = 0.03] and 8% vs. 16% [p < 0.001], respectively). Ninety-five percent of young patients were in New York Heart Association functional class I or II at last follow-up. During a mean follow-up period of 5.4 ± 4.2 years, 165 patients (14%) died. Annual mortality rates of young, middle-age, and older patients were 1%, 2%, and 5%, respectively (p < 0.01). Annual adverse arrhythmic event rates were similar in the 3 age groups at about 1% (p = 0.90). Independent predictors of mortality in young patients were age, female sex, and residual left ventricular outflow tract gradient. Additionally, young patients treated with ≥2.5 ml alcohol had a higher all-cause mortality rate (0.6% vs. 1.4% per year in patients treated with <2.5 ml, p = 0.03). CONCLUSIONS: ASA in younger patients with obstructive hypertrophic cardiomyopathy was safe and effective for relief of symptoms at long-term follow-up. The authors propose that the indication for ASA can be broadened to younger patients.

Outcome of Alcohol Septal Ablation in Mildly Symptomatic Patients With Hypertrophic Obstructive Cardiomyopathy: A Long-Term Follow-Up Study Based on the Euro-Alcohol Septal Ablation Registry.

BACKGROUND: The long-term efficacy and safety of alcohol septal ablation (ASA) in patients with highly symptomatic hypertrophic obstructive cardiomyopathy has been demonstrated. The aim of this study was to evaluate the long-term outcomes of mildly symptomatic patients with hypertrophic obstructive cardiomyopathy treated with ASA. METHODS AND RESULTS: We retrospectively evaluated consecutive patients enrolled in the Euro-ASA registry (1427 patients) and identified 161 patients (53±13 years; 27% women) who were mildly symptomatic (New York Heart Association [NYHA] class II) pre-ASA. The median (interquartile range) follow-up was 4.8 (1.7-8.5) years. The clinical outcome was assessed and compared with the age- and sex-matched general population. The 30-day mortality after ASA was 0.6% and the annual all-cause mortality rate was 1.7%, which was similar to the age- and sex-matched general population (P=0.62). A total of 141 (88%) patients had resting left ventricular outflow tract gradient at the last clinical checkup ≤30 mm Hg. Obstruction was reduced from 63±32 to 15±19 mm Hg (P<0.01), and the mean NYHA class decreased from 2.0±0 to 1.3±0.1 (P<0.01); 69%, 29%, and 2% of patients were in NYHA class I, II, and III at the last clinical checkup, respectively. CONCLUSIONS: Mildly symptomatic hypertrophic obstructive cardiomyopathy patients treated with ASA had sustained symptomatic and hemodynamic relief with a low risk of developing severe heart failure. Their survival is comparable to the general population.

Obstruction after alcohol septal ablation is associated with cardiovascular mortality events.

BACKGROUND: Left ventricular outflow tract obstruction (≥30 mm Hg at rest; LVOTO) is considered a possible risk of long-term outcomes in patients with hypertrophic cardiomyopathy (HCM). However, the influence of LVOTO on the occurrence of cardiovascular mortality events in patients after alcohol septal ablation (ASA) for obstructive HCM remains unresolved. METHODS: We compared the outcomes of patients treated with ASA with residual LVOTO <30 mm Hg with those with residual LVOTO ≥30 mm Hg at the first postdischarge check-up (1-6 months after the procedure). RESULTS: A total of 270 patients (60±12 years, median follow-up 5.1 years; 95% CI 4.5 to 5.9 years) treated with a single ASA were included; 208 (77%) and 62 (23%) patients had post-ASA LVOTO <30 and ≥30 mm Hg at the first postdischarge clinical check-up, respectively (LVOTO 13±6 vs 50±27 mm Hg; p<0.01). Freedom from cardiovascular mortality events at 1, 5 and 10 years were 99% (95% CI 96% to 100%) vs 94% (95% CI 85% to 98%), 95% (95% CI 89% to 97%) vs 80% (95% CI 66% to 89%) and 82% (95% CI 69% to 89%) vs 72% (95% CI 55% to 84%) (log-rank test, p<0.01), respectively. In multivariable analysis adjusted for age at ASA, sex, baseline LVOTO and baseline septum thickness, the independent predictors of cardiovascular mortality events were early postdischarge LVOTO ≥30 mm Hg (HR 2.95, 95% CI 1.26 to 6.91; p=0.01) and baseline septum thickness (HR 1.07, 95% CI 1.01 to 1.13; p=0.02). CONCLUSIONS: After ASA for obstructive HCM, LVOTO ≥30 mm Hg at the first postdischarge clinical check-up is associated with significantly higher occurrence of subsequent cardiovascular mortality events.

Long-term clinical outcome after alcohol septal ablation for obstructive hypertrophic cardiomyopathy: results from the Euro-ASA registry.

AIMS: The first cases of alcohol septal ablation (ASA) for obstructive hypertrophic cardiomyopathy (HCM) were published two decades ago. Although the outcomes of single-centre and national ASA registries have been published, the long-term survival and clinical outcome of the procedure are still debated. METHODS AND RESULTS: We report long-term outcomes from the as yet largest multinational ASA registry (the Euro-ASA registry). A total of 1275 (58 ± 14 years, median follow-up 5.7 years) highly symptomatic patients treated with ASA were included. The 30-day post-ASA mortality was 1%. Overall, 171 (13%) patients died during follow-up, corresponding to a post-ASA all-cause mortality rate of 2.42 deaths per 100 patient-years. Survival rates at 1, 5, and 10 years after ASA were 98% (95% CI 96-98%), 89% (95% CI 87-91%), and 77% (95% CI 73-80%), respectively. In multivariable analysis, independent predictors of all-cause mortality were age at ASA (P < 0.01), septum thickness before ASA (P < 0.01), NYHA class before ASA (P = 0.047), and the left ventricular (LV) outflow tract gradient at the last clinical check-up (P = 0.048). Alcohol septal ablation reduced the LV outflow tract gradient from 67 ± 36 to 16 ± 21 mmHg (P < 0.01) and NYHA class from 2.9 ± 0.5 to 1.6 ± 0.7 (P < 0.01). At the last check-up, 89% of patients reported dyspnoea of NYHA class ≤2, which was independently associated with LV outflow tract gradient (P < 0.01). CONCLUSIONS: The Euro-ASA registry demonstrated low peri-procedural and long-term mortality after ASA. This intervention provided durable relief of symptoms and a reduction of LV outflow tract obstruction in selected and highly symptomatic patients with obstructive HCM. As the post-procedural obstruction seems to be associated with both worse functional status and prognosis, optimal therapy should be focused on the elimination of LV outflow tract gradient.

Multimodality Imaging of Carotid Stenosis.

Four diagnostic modalities are used to image the following internal carotid artery: digital subtraction angiography (DSA), duplex ultrasound (DUS), computed tomography angiography (CTA), and magnetic resonance angiography (MRA). The aim of this article is to describe the potentials of these techniques and to discuss their advantages and disadvantages. Invasive DSA is still considered the gold standard and is an indivisible part of the carotid stenting procedure. DUS is an inexpensive but operator-dependent tool with limited visibility of the carotid artery course. Conversely, CTA and MRA allow assessment of the carotid artery from the aortic arch to intracranial parts. The disadvantages of CTA are radiation and iodine contrast medium administration. MRA is without radiation but contrast-enhanced MRA is more accurate than noncontrast MRA. The choice of methods depends on the clinical indications and the availability of methods in individual centers. However, the general approach to patient with suspected carotid artery stenosis is to first perform DUS and then other noninvasive methods such as CTA, MRA, or transcranial Doppler US.