Alcohol septal ablation or mavacamten for obstructive hypertrophic cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is a genetic disease characterized by an increased left ventricular wall thickness in the absence of increased afterload conditions. In addition to diastolic dysfunction, obstruction of the left ventricular outflow tract is common in HCM and has an important influence on symptoms and outcome. Over the last five decades or two decades, respectively, surgical myectomy and alcohol septal ablation were the only therapeutic options if standard medical care was not sufficient. Recently, a new option has become available that has the potential to revolutionize the therapeutic strategies for patients with HCM. Mavacamten is a myosin inhibitor that belongs to a completely new drug class and targets the excessive actin–myosin cross-bridging that is the underlying pathology of HCM. By reducing the actin–myosin interactions, mavacamten not only reduces the left ventricular outflow tract (LVOT) obstruction but also seems to have positive effects on the diastolic function, microcirculation, and cardiac structure. This article summarizes the current evidence on alcohol septal ablation and reviews the preclinical and clinical data on mavacamten for the treatment of patients with obstructive HCM

Automatic positive airway pressure for obstructive sleep apnea in heart failure with reduced ejection fraction

$\bf Background$ Moderate-to-severe obstructive sleep apnea (OSA) is highly prevalent in heart failure patients with reduced left ventricular ejection fraction (HFrEF), and is associated with worsening cardiac function and increased mortality. $\bf Objectives$ The automatic positive airway pressure (APAP) trial tested the impact of APAP treatment on changes for the pre-specified endpoints: changes in peak oxygen uptake (peak VO$_2$), percent-predicted peak VO$_2$ and oxygen uptake at anaerobic threshold (VO$_2$-AT). $\bf Methods$ This randomized, controlled pilot study included patients with chronic, stable HFrEF who had moderate-to-severe OSA. Patients were randomized 1:1 to either APAP (AutoSet™, ResMed) or nasal strips (control) for 6 months. $\bf Results$ 76 patients have been randomized and 58 had complete data for final analysis. There was a statistically significant change in the APAP intervention arm for the primary endpoint percent-predicted peak VO$_2$ in comparison to control (67 $\pm$ 17 to 73 $\pm$ 19%; $\it p$ = 0.01). Additional primary endpoints peak VO$_2$ and VO$_2$-AT showed a trend in increase in the APAP group. Moreover, there were significant improvements within the APAP group for hypoxemia, left ventricular function and quality of life from baseline to 6 months, but not within the control group ($\it p$ = 0.001 and $\it p$ = 0.037, respectively). $\bf Conclusion$ APAP intervention was shown to significantly improve outcome compared to control group, represented in percent-predicted peak VO$_2$, an established surrogate marker for cardiovascular prognosis in HFrEF. APAP has additional beneficial effects on hypoxemia, cardiac function and quality of life

A comparative study of 1-year postprocedural outcomes in transcatheter mitral valve repair in advanced primary mitral regurgitation

Both the MitraClip and PASCAL systems offer transcatheter edge-to-edge repair (TEER) solutions for mitral regurgitation. Evidence indicates a lower technical success rate for TEER in complex degenerative mitral regurgitation (DMR) cases. We conducted a retrospective analysis of patients who underwent transcatheter edge-to-edge therapy for primary mitral regurgitation with advanced anatomy, defined as mitral regurgitation effective regurgitant orifice area (MR-EROA) $\geq$0.40 $cm^{2}$ or large flail gap ($\geq$5 mm) or width ($\geq$7 mm) or Barlow’s disease, that completed follow-up after 1 year. Our criteria were met by 27 patients treated with PASCAL and 18 with MitraClip. All patients exhibited a significant, equivalent short-term reduction in MR-EROA, mitral regurgitation vena contracta diameter (MR-VCD), regurgitant volume, and clinical status. At 1 year follow-up, reductions in MR-VCD, regurgitant volume, and MR-EROA remained significant for both groups without significant differences between groups. MR-Grade $\leq$ 1+ was achieved in 18 (66.7%) and 10 (55.6%) patients, respectively. At follow-up, no difference in hospitalization for cardiac decompensation was observed. Overall death was similar in both groups. Our study suggests that both the PASCAL and MitraClip systems significantly reduce mitral regurgitation even in advanced degenerative diseases. Within our limited data, we found no evidence of inferior performance of the PASCAL system

PASCAL mitral valve repair system versus MitraClip

$\bf Background$ The PASCAL system is a novel device for edge-to-edge treatment of mitral regurgitation (MR). The aim of this study was to compare the safety and efficacy of the PASCAL to the MitraClip system in a highly selected group of patients with complex primary mitral regurgitation (PMR) defined as effective regurgitant orifice area (MR-EROA) $\geq$  0.40 $cm^{2}$, large flail gap ($\geq$ 5 mm) or width ($\geq$ 7 mm) or Barlow's disease. $\bf Methods$ 38 patients with complex PMR undergoing mitral intervention using PASCAL ($\it n$ = 22) or MitraClip ($\it n$ = 16) were enrolled. Primary efficacy endpoints were procedural success and degree of residual MR at discharge. The rate of major adverse events (MAE) according to the Mitral Valve Academic Consortium (MVARC) criteria was chosen as the primary safety endpoint. $\bf Results$ Patient collectives did not differ relevantly regarding pertinent baseline parameters. Patients´ median age was 83.0 [77.5–85.3] years (PASCAL) and 82.5 [76.5–86.5] years (MitraClip). MR-EROA at baseline was 0.70 [0.68–0.83] $cm^{2}$ (PASCAL) and 0.70 [0.50–0.90] $cm^{2}$ (MitraClip), respectively. 3D-echocardiographic morphometry of the mitral valve apparatus revealed no relevant differences between groups. Procedural success was achieved in 95.5% (PASCAL) and 87.5% (MitraClip), respectively. In 86.4% of the patients a residual MR grade $\leq$ 1 + was achieved with PASCAL whereas reduction to MR grade $\leq$ 1 + with MitraClip was achieved in 62.5%. Neither procedure time number of implanted devices, nor transmitral gradient differed significantly. No periprocedural MAE according to MVARC occured. $\bf Conclusion$ In this highly selected patient group with complex PMR both systems exhibited equal procedural safety. MitraClip and PASCAL reduced qualitative and semi-quantitative parameters of MR to an at least comparable extent

Dynamics of cognitive function in patients with heart failure following transcatheter mitral valve repair

Aims: Interventional transcatheter edge-to-edge mitral valve repair (TMVR) is an established treatment option for patients with severe mitral regurgitation (MR) and high operative risk. Cognitive impairment is one of the most common conditions among often extensive comorbidities in these patients. The specific patterns of cognitive decline and particularly the effect of TMVR are not well described. Thus, this study aimed to investigate into the impact of TMVR on cognitive impairment, exercise capacity, and quality of life. Methods: Cognitive function (executive, naming, memory, attention, language, abstraction, and orientation) was assessed with the standardized Montreal Cognitive Assessment test (MoCA; range between 0 and 30 points) before and 3 months after TMVR in 72 consecutive patients alongside echocardiographic examination and assessment of exercise capacity (six-minute walk test) as well as quality-of-life questionnaires (Minnesota living with heart failure questionnaire, MLHF-Q). Results: Patients’ median age was 81 [76.0; 84.5] years, 39.7% were female with a median EuroScore II of 4.4% [2.9; 7.7]. The assessment of cognitive function showed a significant improvement of the cumulative MoCA-Test result (from 22.0 [19.0; 24.5] to 24 [22.0; 26.0]; $\it p$ < 0.001) with significant changes in the subcategories executive ($\it p$ < 0.001), attention ($\it p$ < 0.001), abstraction ($\it p$ < 0.001), and memory ($\it p$ < 0.001). In addition, quality of life (from 47.5 [25.0; 69.3] to 24.0 [12.0; 40.0]; $\it p$ < 0.001) and exercise capacity (from 220.0 m [160.0; 320.0] to 280.0 m [200.0; 380.0]; $\it p$ = 0.003) increased significantly 3 months after the TMVR procedure. Conclusions: TMVR leads to a significant improvement of cognitive function, exercise capacity, and quality of life in patients with chronic heart failure in 3 months follow up and again highlights the benefit of the evermore established TMVR procedure for patients with high operative risk

Right coronary artery deformation and injury following tricuspid valve surgery

$\bf Background:$ Due to its close anatomical proximity to the annular plane of the tricuspid valve (TV), the right coronary artery (RCA) is at risk of injury and distortion during surgical and interventional repair. Recently, reversible, non-flow limiting, purse-string like deformations of the RCA following percutaneous TV annuloplasty have been described. In contrast, there are only anecdotal reports on RCA deformation following conventional TV surgery. $\textbf {Materials and methods:}$ A retrospective analysis of all patients undergoing TV surgery in our hospital between 2009 and 2019 was performed including all patients who received a post-operative coronary angiography (POCA). Angiographic footage was reviewed for RCA affections. $\bf Results:$ A total of 1,383 patients underwent TV surgery (replacement and repair) for tricuspid regurgitation in our center. TV repair was performed in 1,248 (90.2%) patients and 135 (9.8%) patients underwent isolated TV surgery. Sixty-five patients (4.7%) underwent POCA within 48 h after surgery due to suspected myocardial ischemia, representing the final study population. Mean age was 70.3 $\pm$ 11.3 years, 56.3% were female. Mean EuroSCORE II was 9.8 $\pm$ 11.6%. Patients with the need for POCA due to suspected myocardial injury suffered from a higher mortality compared to event-free patients over the long-term follow up period (median 2.9 years) regardless of the observed coronary status. RCA affections were observed in 24 (36.9%) patients. A new RCA deformation without flow-impairment or vascular damage was found in 16 (24.6%) of the cases and was managed conservatively. There was no significantly worse outcome observed as compared to patients without RCA affections. Six (9.2%) patients showed an RCA deformation accompanied by subtotal occlusion. A complete RCA-occlusion was observed in 2 (3.1%) patients. Revascularization by percutaneous coronary intervention could be successfully performed in these patients. RCA deformation occurred exclusively after TV repair while no cases were observed after TV replacement. $\bf Conclusion:$ Right coronary artery deformation without flow-limitation following surgical TV repair is a specific/typical phenomenon which might not impair patients' outcome and could be managed conservatively in most of the cases. RCA injury indicating further interventional therapy is a rare complication of TV surgery. However, the need for immediate POCA in general appears to be associated with a worsened intermediate-term outcome

Pre-procedural right ventricular longitudinal strain and post-procedural tricuspid regurgitation predict mortality in patients undergoing transcatheter aortic valve implantation (TAVI)

Background: Right ventricular (RV) dysfunction has been linked to worse outcomes in patients undergoing TAVI. Assessment of RV function is challenging due to its complex morphology. RV longitudinal strain (LS) assessed by speckle-tracking echocardiography (STE) is a novel measure that may overcome most of the limitations of conventional echocardiographic parameters of RV function. The aim of current study was to assess the prognostic value of RV LS in patients undergoing TAVI and to assess echocardiographic predictors of long-term mortality. Methods and results: A retrospective analysis of all consecutive patients who underwent TAVI at our hospital between 1 January 2015 and 1 June 2016. Indication for TAVI was approved by a local heart-team. Echocardiographic data at baseline and after TAVI were re-analyzed and RV LS was measured in all patients with adequate image quality. A total of 229 patients were included in our study (mean age 83.8 $\pm$ 5 years, 62% women, mean EuroSCORE II 5.7 $\pm$ 5%). All-cause mortality occurred in 17.3% over a mean follow-up of 929 $\pm$ 373 days. In multivariate analysis, only baseline average RV free-wall LS (HR 1.05, 95% CI (1.01 to 1.10), $\it p$ = 0.049) and more than mild tricuspid valve regurgitation (TR) after TAVI (HR 4.39, 95% CI (2.22 to 8.70), $\it p$ < 0.001) independently increased the risk of all-cause mortality at long- term follow-up (2.5 years), while conventional echocardiographic parameters of RV function did not predict mortality. Conclusion: Pre-procedural RV LS and post-procedural tricuspid regurgitation significantly predicted long-term all-cause mortality in patients undergoing TAVI while conventional echocardiographic parameters of RV function failed in predicting long-term outcome. RV longitudinal strain by STE should be considered in the routine echocardiographic assessments of patients with severe AS

Non-invasive assessment of central venous pressure in heart failure

Assessing hemodynamics, especially central venous pressure (CVP), is essential in heart failure (HF). Right heart catheterization (RHC) is the gold-standard, but non-invasive methods are also needed. However, the role of 2-dimensional echocardiography (2DE) remains uncertain, and 3-dimensional echocardiography (3DE) is not always available. This study investigated standardized and breathing-corrected assessment of inferior vena cava (IVC) volume using echocardiography (2DE and 3DE) versus CVP determined invasively using RHC. Sixty consecutive HF patients were included (82% male, age 54 $\pm$ 11 years, New York Heart Association class 2.23 $\pm$ 0.8, ejection fraction 46 $\pm$ 18.4%, brain natriuretic peptide 696.93 $\pm$ 773.53 pg/mL). All patients underwent Swan-Ganz RHC followed by 2DE and 3DE, and IVC volume assessment. On 2DE, mean IVC size was 18.3 $\pm$ 5.5 mm and 13.8 $\pm$ 6 mm in the largest deflection and shortest distention, respectively. Mean CVP from RHC was 9.3 $\pm$ 5.3 mmHg. Neither 2DE nor 3DE showed acceptable correlation with invasively measured CVP; IVC volume acquisition showed optimal correlation with RHC CVP (0.64; 95% confidence interval 0.46–0.77), with better correlation when mitral valve early diastole E wave and right ventricular end-diastolic diameter were added. Using a CVP cut-point of 10 mmHg, receiver operating characteristic curve showed true positivity (specificity) of 0.90 and sensitivity of 62% for predicting CVP. A validation study confirmed these findings and verified the high predictive value of IVC volume assessment. Neither 2DE nor 3DE alone can reliably mirror CVP, but IVC volume acquisition using echocardiography allows non-invasive and adequate approximation of CVP. Correlation with invasively measured pressure was strongest when CVP is > 10 mmHg

Impact of sleep-disordered breathing treatment on ventricular tachycardia in patients with heart failure

Background: Sleep-disordered breathing (SDB) is a highly common comorbidity in patients with heart failure (HF), and a known risk factor for ventricular tachycardia (VT) development. However, little is known about the impact of SDB treatment on VT burden in HF patients to date. Therefore, this study investigated VT burden, as well as implantable cardioverter-defibrillator (ICD) therapies in HF patients with SDB treatment, in comparison to untreated SDB HF patients. Methods: This retrospective study analyzed VT burden, rate of antitachycardia pacing (ATP), and the number of shocks delivered in a propensity score-matched patient cohort of patients with SDB treatment or control. Patients had moderate or severe SDB (n = 73 per each group; standardized mean difference of 0.08) and were followed for a minimum of one year. In addition, survival over 4 years was assessed. Results: Mean patient age was 67.67 $\pm$ 10.78 and 67.2 $\pm$ 10.10, respectively, with 15.06% and 10.95% of the patients, respectively, being female. Regarding SDB subtypes in the control and SDB treatment group, central sleep apnea was present in 42.46% and 41.09% of the patients, respectively, and obstructive sleep apnea was present in 26.02% and 31.50% of the patients, respectively. Mixed type sleep disorder was present in 31.50% and 27.40% of cases. Among the SDB treatment group, a significantly lower number of VTs (28.8% vs. 68.5%; $\it p$ = 0.01), ATP (21.9% vs. 50.7%; $\it p$ = 0.02), as well as a lower shock rate (5.5% vs. 31.5%; p$\it p$ < 0.01), was observed compared to the control group. Furthermore, the VT burden was significantly lower in the SDB treatment group when compared to the time prior to SDB treatment ($\it p$ = 0.02). Event-free survival was significantly higher in the SDB treatment group (Log-rank $\it p$ < 0.01). Conclusion: SDB treatment in HF patients with ICD leads to significant improvements in VT burden, ATP and shock therapy, and may even affect survival. Thus, HF patients should be generously screened for SDB and treated appropriately

Hemodynamic performance of two current-generation transcatheter heart valve prostheses in severely calcified aortic valve stenosis

Background: Treatment of severely calcified aortic valve stenosis is associated with a higher rate of paravalvular leakage (PVL) and permanent pacemaker implantation (PPI). We hypothesized that the self-expanding transcatheter heart valve (THV) prostheses Evolut Pro (EPro) is comparable to the balloon-expandable Sapien 3 (S3) regarding hemodynamics, PPI, and clinical outcome in these patients. Methods: From 2014 to 2019, all patients with very severe calcification of the aortic valve who received an EPro or an S3 THV were included. Propensity score matching was utilized to create two groups of 170 patients. Results: At discharge, there was significant difference in transvalvular gradients (EPro vs. S3) (dPmean 8.1 vs. 11.1 mmHg, $\it p$ $\leq$ 0.001) and indexed effective orifice area (EOAi) (1.1 vs. 0.9, $\it p$ $\leq$ 0.001), as well as predicted EOAi (1 vs. 0.9, $\it p$ $\leq$ 0.001). Moderate patient prosthesis mismatch (PPM) was significantly lower in the EPro group (17.7% vs. 38%, $\it p$ $\leq$ 0.001), as well as severe PPM (2.9% vs. 8.8%, $\it p$ = 0.03). PPI and the PVL rate as well as stroke, bleeding, vascular complication, and 30-day mortality were comparable. Conclusions: In patients with severely calcified aortic valves, both THVs performed similarly in terms of 30-day mortality, PPI rate, and PVL occurrence. However, patient prothesis mismatch was observed more often in the S3 group, which might be due to the intra-annular design