Safety Of Alcohol Septal Ablation Research Articles

Clinical characteristics and outcomes of alcohol septal ablation in the era of transcatheter valve interventions.

The clinical efficacy and safety of alcohol septal ablation (ASA) for obstructive hypertrophic cardiomyopathy (HCM) have been well-established; however, less is known about outcomes in patients undergoing preemptive ASA before transcatheter mitral valve replacement (TMVR). The goal of this study is to characterize the procedural characteristics and examine the clinical outcomes of ASA in both HCM and pre-TMVR. This retrospective study compared procedural characteristics and outcomes in patient who underwent ASA for HCM and TMVR. In total, 137 patients were included, 86 in the HCM group and 51 in the TMVR group. The intraventricular septal thickness (mean 1.8 vs. 1.2 cm; p < 0.0001) and the pre-ASA LVOT gradient (73.6 vs. 33.8 mmHg; p ≤ 0.001) were higher in the HCM group vs the TMVR group. The mean volume of ethanol injected was higher (mean 2.4 vs. 1.7 cc; p < 0.0001). The average neo-left ventricular outflow tract area increased significantly after ASA in the patients undergoing TMVR (99.2 ± 83.37 mm2 vs. 196.5 ± 114.55 mm2; p = <0.0001). The HCM group had a greater reduction in the LVOT gradient after ASA vs the TMVR group (49.3 vs. 18 mmHg; p = 0.0040). The primary composite endpoint was higher in the TMVR group versus the HCM group (50.9% vs. 25.6%; p = 0.0404) and had a higher incidence of new permanent pacemaker (PPM) (25.5% vs. 18.6%; p = 0.3402). The TMVR group had a higher rate of all-cause mortality (9.8% vs. 1.2%; p = 0.0268). Preemptive ASA before TMVR was performed in patients with higher degree of clinical comorbidities, and correspondingly is associated with worse short-term clinical outcomes in comparison to ASA for HCM patients. ASA before TMVR enabled percutaneous mitral interventions in a small but significant minority of patients that would have otherwise been excluded. The degree of LVOT and neoLVOT area increase is significant and predictable.

Comparative Evaluation of Alcohol Septal Ablation: Left Anterior Descending Versus Non-left Anterior Descending Artery Approaches

Alcohol septal ablation (ASA) is performed for symptomatic drug-refractory hypertrophic obstructive cardiomyopathy to reduce the left ventricular outflow tract pressure gradient (LVOTPG) by injecting ethanol into a septal branch that perforates the septal bulge. The target septal branches usually arise directly from the left anterior descending (LAD) artery; however, vessels from a non-LAD artery can be selected in some cases. This study aimed to compare effectiveness and safety between ASA performed using a septal branch arising from a non-LAD artery and a branch arising from the LAD artery. This single-center, retrospective, observational cohort study comprised patients with hypertrophic obstructive cardiomyopathy who underwent ASA at the Gifu Heart Centre between 2011 and 2022. The effectiveness and safety of ASA using the 2 artery types were compared. The primary endpoints were LVOTPG and procedure success, determined as LVOTPG <30 mmHg after 1 year. Of 33 patients (mean age: 66.4 ± 13.0 years; 13 males), 18 patients who underwent ASA using only LAD branches and 15 patients who underwent ASA using only non-LAD branches demonstrated no significant difference in the decrease in LVOTPG during the follow-up period (−99.1 ± 47.4 mmHg/year vs. −75.7 ± 39.2 mmHg/year, respectively, P = 0.19). The procedure success at 1 year was not significantly different between the 2 groups (93.3% and 84.6%, respectively, P = 0.58). ASA performed using septal branches from non-LAD arteries could be an alternative treatment approach when appropriate septal branches are missing or desirable effects cannot be obtained from ASA using LAD branches.

Abstract 14235: Alcohol Septal Ablation Using Septal Branches From the Non-Left Anterior Descending Artery Demonstrates Similar Effectiveness Compared to Septal Branches From Left Anterior Descending Artery

Introduction: Alcohol septal ablation (ASA) is performed on symptomatic, drug-refractory hypertrophic obstructive cardiomyopathy to reduce pressure gradient in the left ventricular outflow tract (LVOT), usually using the major septal branch from the left anterior descending (LAD) artery. In some cases, a septal branch from other than LAD may be selected as an alternative target that perfuses the basal septum. The aim of this study is to evaluate the effectiveness and safety of ASA using non-LAD branches compared to ASA using major branches directly from the LAD. Methods: We conducted a single-center, retrospective, observational cohort study comprising patients who underwent ASA between 2011 and 2023. The primary outcome was the success rate, defined as a pressure gradient in the LVOT of less than 30 mmHg one year after ASA. The secondary outcomes were all-cause death, cardiac rehospitalization, and newly-developed conduction system disorders. Results: The study enrolled 36 patients (age: 66.6± 12.7 years; 13 men), and pressure gradients in LVOT before ASA were not significantly different in the two groups (76±50 mmHg in the non-LAD group (n =17) vs. 76±39 mmHg in the LAD group (n = 19), p= 0.90). The non-LAD and LAD groups had similar success rates of 88.2 % and 86.7 %, respectively, at one year (p &gt; 0.99). The decrease in the pressure gradient in LVOT was similarly observed in both groups (61±44 mmHg in the non-LAD group vs. 61±35 mmHg in the LAD group, p=0.87). No patient died in either group within one year following ASA. The study found a non-significant incidence of newly-developed conduction system disorder (11.8 % in the non-LAD group vs. 5.3 % in the LAD group, P= 0.92). Conclusions: ASA using the non-LAD artery demonstrated similar effectiveness in decreasing the pressure gradient in the LVOT and similar safety compared to using the septal branch from the LAD at one year. Therefore, the non-LAD artery may become an alternative option for the target vessel in ASA.

Septal Myectomy or Alcohol Ablation for Hypertrophic Cardiomyopathy: A Nationwide Inpatient Sample (NIS) Database Analysis

BackgroundComparison of the real-world cohort on the relative safety of alcohol septal ablation (ASA) vs. septal myectomy (SM) for the management of hypertrophic cardiomyopathy (HCM) has been lacking. MethodsThe National Inpatient Sample (NIS) (2012–2019) was used to select all cases of HCM. The safety of ASA vs. SM was compared using a one:many propensity score matched (PSM) analysis. Adjusted odds ratios (aOR) for mortality and other in-hospital complications were computed. ResultsA total of 6208 HCM patients (ASA 3106 vs. SM 3102) were included using a PSM analysis. Post-procedural bleeding (aOR 0.18, 95 % CI 0.11–0.32, p < 0.0001) and the need for an intra-aortic balloon pump (aOR 0.51, 95 % CI, 0.28–0.96, p = 0.037) were significantly lower while permanent pacemaker (PPM) implantation was significantly higher in ASA group as compared with SM group (aOR 1.72, 95 % CI, 1.43–2.06, p < 0.0001). The total in-hospital mean adjusted cost and length of stay were also significantly lower in the ASA group. However, there were no significant differences in adjusted odds of all-cause mortality (aOR 0.91, 95 % CI 0.62–1.33, p = 0.61), stroke (aOR 0.91, 95 % CI, 0.59–1.4, p = 0.66), and major bleeding (aOR 1.0, 95 % CI 7.8–1.29, p = 0.99) between the two comparison groups. ConclusionIn patients with hypertrophic cardiomyopathy, alcohol septal ablation appears to be an acceptable alternative to septal myectomy due to a lower risk of post-procedural bleeding and the need for an intra-aortic balloon pump. However, ASA confers a higher risk of PPM placement.

Abstract 11462: Alcohol Septal Ablation vs Surgical Myectomy for Hypertrophic Cardiomyopathy: A Systematic Review and Meta-Analysis

Introduction: Surgical Myectomy (SM) is the gold standard treatment for hypertrophic obstructive cardiomyopathy (HOCM). However, alcohol septal ablation (ASA) has emerged as an alternative option for selected patients. Nonetheless, the long-term efficacy and safety of ASA have been debated in recent years. The aim of this metanalysis is to evaluate the long-term outcomes of ASA vs SM in HOCM patients. Hypothesis: ASA is a safe and effective alternative to SM in HOCM. Methods: : Unrestricted searches of the PubMed, EMBASE, and Cochrane databases from inception till June 1, 2022, for studies comparing long-term outcomes of ASA with SM in HOCM patients. Relevant data were extracted and analyzed using Revman 5.3 software. Odds Ratio (OR) and 95% Confidence interval (CI) were calculated using the random-effects model. Results: : A total of 12 retrospective studies were included examining 7,599 HOCM patients (2,010 ASA vs 5,589 SM). After a mean follow-up of 5.04 years, all-cause mortality was similar between the two groups (OR 1.18; 95% CI 0.60-2.29). However, ASA was associated with high rates of reinterventions (OR 15.68; 95% CI 6.71-36.61), and pacemaker insertion (OR 2.74; 95% CI 1.39-5.41). Conclusions: Although there was no difference in mortality between ASA and SM, ASA was associated with higher rates of reinterventions and pacemaker insertion in long-term follow-up. Therefore, the selection of septal reduction therapy in HOCM should be individualized and should be performed in a comprehensive center after detailed risk and benefits discussions with an experienced team.

Efficacy and safety of alcohol septal ablation in adolescents and young adults with symptomatic hypertrophic obstructive cardiomyopathy

Abstract Background In young patients suffering from hypertrophic obstructive cardiomyopathy (HOCM) surgical myectomy is still considered as the gold standard for septal reduction therapy. Purpose To assess the safety and efficacy of alcohol septal ablation (ASA) for reduction of left ventricular outflow tract gradient (LVOTG) and symptoms in HOCM patients ≤25 years. Methods and results All ASA procedures performed at our institution between 2002 and 2020 were retrospectively allocated to a patient group ≤25 years (group 1) and a reference group &amp;gt;25 years (group 2). Patients were evaluated at baseline and chronic follow-up (FU) after 6 months. 1,264 procedures were analysed in group 2 (58.6±13.5 years) and 41 procedures in group 1 (20.9±3.3 years). Proportion of family history of sudden cardiac death was higher in group 1 (56.1% vs. 24.6% in group 2; p&amp;lt;.0001). We more often found a previously implanted cardiac device in group 1 (31.7% vs. 9.0% in group 2; p&amp;lt;.0001) and the interventricular septal diameter (IVSD) was higher in young patients at baseline (26.0±6.5 mm vs. 21.3±4.4 mm in group 2; p&amp;lt;.0001). LVOTG at baseline did not differ between the groups (54.4±24.4 mmHg in group 1 vs. 52.4±36.6 mmHg in group 2 (p=n.s.). Relief of symptoms was shown for both groups at FU compared to baseline (group 1: mean NYHA class 2.5 at baseline and 1.3 at FU; p&amp;lt;.0001; group 2: mean NYHA class 2.7 at baseline and 1.4 at FU; p&amp;lt;.0001). Compared to baseline IVSD was significantly reduced at FU (20.3±8.2 mm in group 1 at FU; 16.8±5.7 mm in group 2 at FU; p&amp;lt;.0001 for each group compared to baseline). LVOTG improved significantly during FU (25.5±20.0 mmHg in the young patients; 22.1±21.7 mmHg in the reference group; p&amp;lt;.0001 for each group compared to baseline). Mortality was 0.0% in patients ≤25 years and 0.9% in the reference group. Conclusion Our data demonstrate safety and efficacy of ASA to improve LVOT obstruction and symptoms in young adults and adolescents (14–25 years) suffering from symptomatic HOCM. Therefore, ASA may be considered also for this patient population. However, these results may only hold for experienced centres and, thus, invasive procedures in young patients should be reserved to centres with the required expertise. Funding Acknowledgement Type of funding sources: None. Table 1. Baseline characteristics. ASA = alcohol septal ablation. ICD = implantable cardioverter-defibrillator. IVSD= interventricular septum diameter. LA = left atrium. LVOTG = left ventricular outflow tract gradient. n.s. = not significant. PM = pacemaker. SCD = sudden cardiac death. SM = septal myectomy.Figure 1. Echocardiographic parameters in patients ≤25 years at baseline and follow-up (FU) 6 months after alcohol septal ablation. ****p&amp;lt;.0001. A. Interventricular septum diameter (IVSD). B. Left ventricular outflow tract gradient (LVOTG).

Short- and long-term outcome after alcohol septal ablation in obstructive hypertrophic cardiomyopathy: Experience of a reference center

IntroductionIn obstructive hypertrophic cardiomyopathy (HCM), alcohol septal ablation (ASA) can lead to gradient reduction and symptom improvement. We aimed to assess the efficacy and safety of ASA in a long-term outcome study. MethodsWe analyzed patients who underwent ASA over a seven-year period in a tertiary center. The primary echocardiographic endpoint was >50% reduction in left ventricular outflow tract (LVOT) gradient within a year of the procedure. The primary clinical endpoints were improvement in functional capacity and a combined endpoint of cardiac death and rehospitalization for cardiac cause. The follow-up period was 4.17±2.13 years. ResultsA total of 80 patients, mean age 63.9±12.3 years, 30.0% male, were analyzed. Baseline LVOT gradient was 96.3±34.6 mmHg and interventricular septal thickness was 21.6±3.1 mm. Minor complications were observed in 6.3% and major complications in 2.5%, and 8.8% received a permanent pacemaker.The primary echocardiographic endpoint was achieved by 85.7%. At three-month follow-up, LVOT gradient was 25.8±26.0 mmHg in the successful procedure group, compared to 69.2±35.6 mmHg in the other patients (p=0.001). At six months, LVOT gradient was 27.1±27.4 vs. 58.2±16.6 mmHg (p=0.024). Among 74 patients in NYHA class III/IV before the procedure, 57 (77%) improved to NHYA class I/II. The combined primary clinical endpoint (cardiac death and rehospitalization for cardiac cause) was observed in 27.5% (n=22). In the unsuccessful group, the combined endpoint was observed in 54.5%, compared to only 22.7% in the successful group. Only two patients died of cardiac causes. ConclusionASA is a safe procedure with a high success rate. Patients who achieved significant reductions in LVOT gradient suffered less cardiac death and rehospitalization for cardiac cause.

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.

BackgroundThe 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 ResultsWe 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.ConclusionsMildly 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.

Efficacy and safety of alcohol septal ablation in patients over 65 years old with obstructive hypertrophic cardiomyopathy.

BackgroundThe performance of alcohol septal ablation (ASA) in elderly symptomatic patients with drug-refractory obstructive hypertrophic cardiomyopathy is still to be confirmed. The objective of this study was to compare the efficacy and safety of ASA in patients under and over 65 years old.Methods and resultsFifty-one consecutive patients with obstructive hypertrophic cardio-myopathy who underwent ASA were retrospectively included and reviewed for in-hospital major acute cardiac events and follow-up. Twenty-eight patients were over 65 years old. Left ventricular outflow tract obstruction at rest, use of diuretic and average dose of diuretic were higher in patients over 65 years old. There was no difference in hospital stay between patients under and over 65 years old. Among patients over 65 years old, 2 (7%) died before being discharged. Major acute cardiac events were more frequent in patients over 65 years old in comparison with younger patients (43% versus 9%, respectively, P=0.007). The average follow-up duration was 16±15 months. There was no difference between patients under and over 65 years old regarding the efficacy of the procedure with a decrease of the New York Heart Association class of 1.3±0.6 and 1.4±0.7 (P=0.510) and the maximum left ventricular outflow tract gradient of 86±57 and 81±36 mmHg (P=0.733), respectively.ConclusionElderly patients have the same benefits as younger patients after ASA but have more complications including mortality events.

Survival of Patients ≤ 50 Years of Age After Alcohol Septal Ablation for Hypertrophic Obstructive Cardiomyopathy

BackgroundThe long-term efficacy and safety of alcohol septal ablation (ASA) has recently been demonstrated. However, there is still debate about the outcome of younger patients who should be treated using myectomy, according to American College of Cardiology Foundation/American Heart Association guidelines. The aim of this study was to evaluate the long-term outcome of patients ≤ 50 years of age after ASA for hypertrophic obstructive cardiomyopathy (HOCM). MethodsWe retrospectively evaluated consecutive, highly symptomatic patients aged ≤ 50 years with HOCM who underwent ASA. ResultsInstitutional databases of 3 cardiovascular centres identified 290 patients with HOCM who underwent ASA; 75 (26%) of them were aged ≤ 50 years at the time of their first ASA. Median duration of follow-up was 5.1 years (range, 0.1-15.4 years). Four patients (5%) died during the study period (438 patient-years; the annual mortality rate was 0.91%; 95% confidence interval [CI], 0.25-2.34%; the annual mortality rate combined with the first appropriate implantable cardioverter-defibrillator discharge was 1.43%; 95% CI, 0.52-3.10%). Survival free of all-cause mortality at 1, 5, and 10 years was 97% (95% CI, 89-99%), 94% (95% CI, 84-98%), and 94% (95% CI, 84-98%), respectively. ConclusionsResults of this first study focused on HOCM patients aged ≤ 50 years who underwent ASA suggest a low risk of all-cause death or appropriate implantable cardioverter-defibrillator discharge in the long-term follow-up.

Alcohol septal ablation for obstructive hypertrophic cardiomyopathy: Outcomes in young, middle‐aged, and elderly patients

We compared the efficacy and safety of alcohol septal ablation (ASA) for obstructive hypertrophic cardiomyopathy (HCM) in young, middle-aged, and elderly patients. Intersociety guidelines suggest based on limited evidence that young patients with medically refractory symptoms of obstructive HCM should undergo surgical myectomy while elderly patients may be more appropriate for ASA. Data for 360 patients undergoing 389 ASAs were prospectively collected and retrospectively analyzed according to age. Young (<45 years), middle-aged (45-64 years), and elderly (≥65 years) patients comprised 28, 40, and 32% of the study population, respectively. Young patients had thicker left ventricular septal walls at baseline, and elderly patients had more comorbidity and dyspnea. Resting, mean left ventricular outflow tract gradients (LVOTGs) were similar across the age groups at baseline (62, 66, and 68 mm Hg, respectively; P = NS for all comparisons). LVOTGs and dyspnea were significantly and similarly improved in all age groups immediately after ASA and through 12 months of follow-up (P < 0.001 for before and after comparisons; P = NS for intergroup comparisons). Complication rates were similar for young and middle-aged patients but higher for elderly patients (9.1 and 6.3% vs. 20.8%, respectively; P ≤ 0.016 for elderly vs. others). Mortality rates for young and middle-aged patients were lower than for elderly patients, but the differences were not statistically significant. Patients undergoing ASA had significant and similar improvements in LVOTGs and symptoms regardless of age. Procedural complications were increased in elderly patients, who had numerically but not statistically significantly higher mortality rates.

Transradial approach and subclavian wired temporary pacemaker to increase safety of alcohol septal ablation for treatment of obstructive hypertrophic cardiomyopathy: The TRASA trial

Alcohol septal ablation (ASA) is a therapeutic catheter-based option and an alternative to surgical myectomy in the treatment of patients with hypertrophic obstructive cardiomyopathy. Although the safety of the ASA procedure has been consistently improved, a temporary transvenous pacemaker is recommended for at least 48h postprocedure, with several drawbacks, including the risk of cardiac perforation and infection, and the absence of any fixation mechanism. In addition, femoral artery catheterization has resulted in a concomitant increase in bleedings and iatrogenic femoral artery injuries. To evaluate and validate the feasibility of less invasive management of ASA using the transradial approach and a subclavian wired temporary pacemaker. To avoid transfemoral temporary pacing, we used a subclavian bipolar active-fixation permanent pacing lead, stitched to the skin and connected to a desterilized recuperation pacemaker. The day before discharge, if there was no high-degree atrioventricular block, the pacemaker lead was removed. In all patients, we used the right radial access and the left main was cannulated with a 6F Judkins left 3.5 guiding catheter. Thirty consecutive patients were prospectively and successfully included in our study. No complication was observed during the hospital stay, neither access-site nor stimulation-lead related. Our study shows the feasibility and safety of a transradial approach and a subclavian wired temporary pacemaker. The reduction in periprocedural complications offered by this strategy reflects the less invasive nature of ASA, without increasing the cost and complexity of the procedure.

Initial Experience with Alcohol Septal Ablation Using a Novel Magnetic Navigation System

We compared the use of magnetically assisted intervention (MAI) with conventional guidewire techniques to perform alcohol septal ablation (ASA) in patients with hypertrophic obstructive cardiomyopathy (HOCM). Treatment of symptomatic patients with HOCM using ASA has been established as an effective therapy. However, in many cases cannulaton of the septal artery can be technically challenging. Recently, a magnetically directed guidewire system has been developed to assist in navigation in difficult percutaneous interventions. By directing the guidewire to the septal branch, this system has potential to shorten the procedure time and increase success and safety of ASA in patients with HOCM. From October 2004 through October 2006, 44 consecutive patients underwent ASA using MAI with the Niobe system (Stereotaxis, Inc., St. Louis, MO). We compared these patients to 29 age- and gradient-matched cases using conventional techniques performed by an operator with >100 prior cases. All procedures were successful. Both the MAI and conventional groups had improved symptoms, exercise times, and reduced gradients compared with baseline. One dissection occurred in the conventional group. Although there were no aggregate differences in acute or 3-month clinical outcomes, the time required for guidewire cannulation of the septal branch decreased progressively with increasing experience (third tertile vs first tertile (3 [1.25-4.75 vs 10.5 [6-17] minutes, P = 0.004) compared with the conventional group (6 [2-10.25] minutes, P = 0.075 vs third tertile), suggesting a learning curve for MAI. MAI has the potential to improve wiring time and outcomes of HOCM patients undergoing ASA.