Thomas Bartel

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

AIMSnThe 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.nnnMETHODS AND RESULTSnWe 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).nnnCONCLUSIONSnThe 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.

Early outcomes of alcohol septal ablation for hypertrophic obstructive cardiomyopathy: a European multicenter and multinational study.

Background: This study was designed to evaluate the outcomes of alcohol septal ablation (ASA) under multicenter and multinational conditions. Methods: Data for 459 patients (age 57u2009±u200913 years) from nine European centers were prospectively collected and retrospectively analyzed. Results: ASA led to a significant reduction in outflow gradient (PG) and dyspnea [median of PG from 88 (58–123) mm Hg to 21 (11–41) mm Hg; median of NYHA class from 3 (2–3) to 1 (1–2); Pu2009<u20090.01]. The incidence of 3‐month major adverse events (death, electrical cardioversion for tachyarrhythmias, resuscitation) and mortality was 2.8% and 0.7%, respectively. Permanent pacemakers for post‐ASA complete heart block were implanted in 43 patients (9%). Multivariate analysis identified higher amount of alcohol (however, in generally low‐dose procedures), higher baseline left ventricular ejection fraction and higher age as independent predictors of PG decrease ≥50%. Conclusions: The results of the first European multicenter and multinational study demonstrate that real‐world early outcomes of ASA patients are better than was reported in observations from the first decade after ASA introduction.

Medical three-dimensional printing opens up new opportunities in cardiology and cardiac surgery

Advanced percutaneous and surgical procedures in structural and congenital heart disease require precise pre-procedural planning and continuous quality control. Although current imaging modalities and post-processing software assists with peri-procedural guidance, their capabilities for spatial conceptualization remain limited in two- and three-dimensional representations. In contrast, 3D printing offers not only improved visualization for procedural planning, but provides substantial information on the accuracy of surgical reconstruction and device implantations. Peri-procedural 3D printing has the potential to set standards of quality assurance and individualized healthcare in cardiovascular medicine and surgery. Nowadays, a variety of clinical applications are available showing how accurate 3D computer reformatting and physical 3D printouts of native anatomy, embedded pathology, and implants are and how they may assist in the development of innovative therapies. Accurate imaging of pathology including target region for intervention, its anatomic features and spatial relation to the surrounding structures is critical for selecting optimal approach and evaluation of procedural results. This review describes clinical applications of 3D printing, outlines current limitations, and highlights future implications for quality control, advanced medical education and training.

Intracardiac echocardiography for guidance of transcatheter aortic valve implantation under monitored sedation: a solution to a dilemma?

Transcatheter aortic valve implantation (TAVI) has been established as a valuable alternative to surgical aortic valve replacement in patients deemed to have high or prohibitive perioperative risk. However, there are several technical constraints and procedural risks inherent to TAVI. These risks include annulus rupture, ventricular perforation, aortic dissection, coronary occlusion, and dislodgement or migration of the valve prosthesis to the aorta or the left ventricle (LV). Other complications may be related to inappropriate valve deployment and subsequent paravalvular leak. Most complications cannot be detected at an early stage without echocardiographic guidance. Although not addressed by current guidelines, some European centres have advocated a minimalist approach with exclusively fluoroscopic and angiographic guidance. Transoesophageal echocardiography (TEE), including real-time three-dimensional (RT-3D) imaging, has been established as a standard approach for peri-interventional guidance of TAVI. However, TEE monitoring almost always necessitates general anaesthesia and endotracheal intubation. A potential alternative to TEE is intracardiac echocardiography (ICE) that may provide a solution to a common dilemma: the most important advantage of ICE being the compatibility with monitored anaesthesia care without endotracheal intubation. Other advantages of ICE include uninterrupted monitoring, no fluoroscopic interference, and precise Doppler-based assessment of pulmonary artery pressures. Limitations of ICE include the need for additional venous access, the learning curve associated with a new device, and potentially increased cost.

Three-dimensional printing for quality management in device closure of interatrial communications

We report the case of a 48-year-old male who was found to have an atrial septal defect (ASD) of the secundum type with evidence of moderate right heart load requiring elective device closure. Intraprocedural balloon-sizing showed an average stretched diameter of 16 mm. The decision was made to implant a …

Risk and Causes of Death in Patients After Alcohol Septal Ablation for Hypertrophic Obstructive Cardiomyopathy

BACKGROUNDnBecause the final myocardial scar might be theoretically associated with an increased risk of sudden cardiac death, the long-term clinical course of patients who undergo alcohol septal ablation (ASA) is still a matter of debate. In this retrospective multicentre study, we report outcomes after ASA, including survival, analysis of causes of deaths, and association between time and cause of death.nnnMETHODSnWe enrolled 366 consecutive patients (58 ± 12 years, 54% women) who were treated using ASA and followed-up for 5.1 ± 4.5xa0years.nnnRESULTSnThe in-hospital and 30-day mortality were 0.5% and 0.8%, respectively; the ASA-related morbidity was < 20%. Overall, 52 patients died during 1867 patient-years, which means the all-cause mortality rate was 2.8% per year. The mortality rates of sudden death and sudden death with an appropriate implantable cardioverter-defibrillator (ICD) discharge were 0.4% and 1% per year, respectively. Patients with sudden death or appropriate ICD discharge experienced these mortality events at younger age than patients who died of other hypertrophic obstructive cardiomyopathy-related causes (60.8 years [range, 52-71.5 years] vs 72.4 years [range, 64.2-75.2 years]; Pxa0=xa00.048). A total of 292 patients (80%) had an outflow gradient ≤ 30 mm Hg, and 327 patients (89%) were in New York Heart Association class ≤ II at the last clinical check-up.nnnCONCLUSIONSnASA had low procedure-related mortality, with subsequent 1% occurrence of sudden mortality events per year and 2.8% mortality rate per year in the long-term follow-up. Patients with sudden death or ICD discharge experienced the mortality events approximately 1 decade earlier than patients who died from other causes not related to hypertrophic cardiomyopathy.

Intracardiac Doppler Echocardiography for Monitoring of Pulmonary Artery Pressures in High-Risk Patients Undergoing Transcatheter Aortic Valve Replacement

BACKGROUNDnUncontrolled pulmonary hypertension may cause worse outcomes after transcatheter aortic valve replacement (TAVR), while hemodynamic monitoring is desirable for risk control. Pulmonary artery pressure (PAP) readings obtained by intracardiac Doppler echocardiography were evaluated.nnnMETHODSnIn 114 patients with symptomatic aortic stenosis and median Society of Thoracic Surgeons scores of 10.5% (interquartile range, 7.7%-15.0%), transfemoral and transapical TAVR was guided by intracardiac Doppler echocardiography. The continuous-wave Doppler beam interrogated the jet of tricuspid regurgitation from the home view position. Systolic PAP (PAPs) was estimated as the sum of the pressure gradient derived from the maximum transtricuspid regurgitation jet velocity and the central venous pressure. Mean PAP (PAPm) was calculated by the mean gradient method (1) and the Chemla formula (2). Measurements were obtained immediately before and after TAVR.nnnRESULTSnPre- and postinterventional readings showed marginal pressure underestimation in comparison with measurements derived from right-heart catheterization: PAPs, -2.7 (95% CI, -3.3 to 2.1) and -1.4 (95% CI, -1.9 to -0.9); PAPm by the mean gradient method, -1.9 (95% CI, -2.2 to -1.6) and -0.1 (95% CI, -0.4 to 0.2). Agreement (95% limits) for PAPs was -8.6 to 3.2 and -6.8 to 4.0; agreement for PAPm by the mean gradient method was -5.4 to 1.6 and -3.4 to 3.2. The repeatability coefficient (95% limits of agreement) for PAPs was excellent: 3.4 (-4.2 to 2.5) and 5.5 (-5.3 to 5.8); repeatability for PAPm was higher by the mean gradient method than by the Chemla method. In ≥ 85% of patients with pulmonary hypertension, PAPm improved after valve deployment.nnnCONCLUSIONSnIntracardiac Doppler echocardiography-derived monitoring of PAP by the mean gradient method is accurate and well applicable to high-risk TAVR candidates for intraprocedural risk control.

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.

Low procedure-related mortality achieved with alcohol septal ablation in European patients

Two thirds of patients with hypertrophic cardiomyopathy (HCM) suffer from a left ventricular obstruction associated with more symptoms and worse prognosis [1] ; [2]. According to American and European Guidelines on HCM, there are two main therapeutic alternatives for treating the left ventricular obstruction: surgical myectomy and alcohol septal ablation (ASA) [1] ; [2]. Both these alternatives are considered safe and effective. However, Panaich et al. have recently demonstrated real world American data from the Nationwide Inpatient Sample (NIS) database showing an almost 6% in-hospital mortality rate associated with surgical myectomy [3]. This study is important because it contradicts lower, previously established post-operative mortality rates, which were estimated to be ~ 1% and were calculated using data from high-volume centers. Importantly, however, current guidelines on HCM have been based only on results of these high-volume centers [1] ; [2]. Along this line, Maron et al. recently found that in five major high-volume HCM centers in North America, the 30-day operative mortality rate was only 0.4% over the past 15 years (n = 3.696, mean age 54 ± 14 years) [4], i.e., one fifteenth of mortality rate reported by Panaich et al. [3]. A recent meta-analysis of long-term outcomes after septal reduction therapy, including 24 studies from tertiary HCM centers around the world, showed that the peri-procedural mortality rate of ASA was 1.3%, compared to 2.5% in patients undergoing myectomy [5]. However, when studies from before the year 2000 were excluded, as Maron et al. suggest [4], these figures became similarly low (1.3% vs. 1.1%, respectively). The same held true for the long-term mortality rates.

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

BACKGROUNDnThe 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.nnnMETHODSnWe 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).nnnRESULTSnIn 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%; Pxa0=xa00.01) and implanted pacemakers (15% vs 9%; Pxa0<xa00.01). 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 (Pxa0<xa00.01) 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 (Pxa0= 0.03).nnnCONCLUSIONSnAn 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.