mPAP/CO Slope and Oxygen Uptake Add Prognostic Value in Aortic Stenosis.

BACKGROUND: Recent guidelines redefined exercise pulmonary hypertension as a mean pulmonary artery pressure/cardiac output (mPAP/CO) slope >3 mm Hg·L-1·min-1. A peak systolic pulmonary artery pressure >60 mm Hg during exercise has been associated with an increased risk of cardiovascular death, heart failure rehospitalization, and aortic valve replacement in aortic valve stenosis. The prognostic value of the mPAP/CO slope in aortic valve stenosis remains unknown. METHODS: In this prospective cohort study, consecutive patients (n=143; age, 73±11 years) with an aortic valve area ≤1.5 cm2 underwent cardiopulmonary exercise testing with echocardiography. They were subsequently evaluated for the occurrence of cardiovascular events (ie, cardiovascular death, heart failure hospitalization, new-onset atrial fibrillation, and aortic valve replacement) during a follow-up period of 1 year. Findings were externally validated (validation cohort, n=141). RESULTS: One cardiovascular death, 32 aortic valve replacements, 9 new-onset atrial fibrillation episodes, and 4 heart failure hospitalizations occurred in the derivation cohort, whereas 5 cardiovascular deaths, 32 aortic valve replacements, 1 new-onset atrial fibrillation episode, and 10 heart failure hospitalizations were observed in the validation cohort. Peak aortic velocity (odds ratio [OR] per SD, 1.48; P=0.036), indexed left atrial volume (OR per SD, 2.15; P=0.001), E/e' at rest (OR per SD, 1.61; P=0.012), mPAP/CO slope (OR per SD, 2.01; P=0.002), and age-, sex-, and height-based predicted peak exercise oxygen uptake (OR per SD, 0.59; P=0.007) were independently associated with cardiovascular events at 1 year, whereas peak systolic pulmonary artery pressure was not (OR per SD, 1.28; P=0.219). Peak Vo2 (percent) and mPAP/CO slope provided incremental prognostic value in addition to indexed left atrial volume and aortic valve area (P<0.001). These results were confirmed in the validation cohort. CONCLUSIONS: In moderate and severe aortic valve stenosis, mPAP/CO slope and percent-predicted peak Vo2 were independent predictors of cardiovascular events, whereas peak systolic pulmonary artery pressure was not. In addition to aortic valve area and indexed left atrial volume, percent-predicted peak Vo2 and mPAP/CO slope cumulatively improved risk stratification.

Postprocedural trans-mitral gradient in patients with degenerative mitral regurgitation undergoing mitral valve transcatheter edge-to-edge repair.

BACKGROUND: The relationship between high postprocedural mean gradient (ppMG) and clinical events following mitral valve transcatheter edge-to-edge repair (MV-TEER) in patients with degenerative mitral regurgitation (DMR) is still debated. AIM: The purpose of this study was to evaluate the effect of elevated ppMG after MV-TEER on clinical events in patients with DMR at 1-year follow-up. METHODS: The study included 371 patients with DMR treated with MV-TEER enrolled in the "Multi-center Italian Society of Interventional Cardiology (GISE) registry of trans-catheter treatment of mitral valve regurgitation" (GIOTTO) registry. Patients were stratified in tertiles according to ppMG. Primary endpoint was a composite of all-cause death and hospitalization due to heart failure at 1-year follow-up. RESULTS: Patients were stratified as follows: 187 with a ppMG ≤ 3 mmHg, 77 with a ppMG > 3/=4 mmHg, and 107 with a ppMG > 4 mmHg. Clinical follow-up was available in all subjects. At multivariate analysis, neither a ppMG > 4 mmHg nor a ppMG ≥ 5 mmHg were independently associated with the outcome. Notably, the risk of elevated residual MR (rMR > 2+) was significantly higher in patients belonging to the highest tertile of ppMG (p = 0.009). The association of ppMG > 4 mmHg and rMR ≥ 2+ was strongly and independently associated with adverse events (hazard ratio: 1.98; 95% confidence interval: [1.10-3.58]). CONCLUSIONS: In a real-world cohort of patients suffering DMR and treated with MV-TEER, isolated ppMG was not associated with the outcome at 1-year follow-up. A high proportion of patients showed both elevated ppMG and rMR and their combination appeared to be a strong predictor of adverse events.

Non-continuous mobile electrocardiogram monitoring for post-transcatheter aortic valve replacement delayed conduction disorders put to the test.

AIMS: Permanent pacemaker implantation (PPM-I) remains nowadays the most important drawback of transcatheter aortic valve replacement (TAVR) procedure and the optimal strategy of delayed conduction disturbances (CDs) in these patients is unclear. The study aimed to validate an ambulatory electrocardiogram (ECG) monitoring through a 30 s spot ambulatory digital mobile ECG (AeECG), by using KardiaMobile-6L device in a 30-day period after TAVR procedure. METHODS AND RESULTS: Between March 2021 and February 2022, we consecutively enrolled all patients undergoing TAVR procedure, except pacemaker (PM) carriers. At discharge, all patients were provided of a KardiaMobile-6L device and a spot digital ECG (eECG) recording 1 month schedule. Clinical and follow-up data were collected, and eECG schedule compliance and recording quality were explored. Among 151 patients without pre-existing PM, 23 were excluded for pre-discharge PPM-I, 18 failed the KardiaMobile-6L training phase, and 10 refused the device. Delayed CDs with a Class I/IIa indication for PPM-I occurred in eight patients (median 6 days). Delayed PPM-I vs. non-delayed PPM-I patients were more likely to have longer PR and QRS intervals at discharge. PR interval at discharge was the only independent predictor for delayed PPM-I at multivariate analysis. The overall eECG schedule compliance was 96.5%. None clinical adverse events CDs related were documented using this new AeECG monitoring modality. CONCLUSION: A strategy of 30 s spot AeECG is safe and efficacious in delayed CDs monitoring after TAVR procedure with a very high eECG schedule level of compliance.

Bio-Humoral and Non-Invasive Haemodynamic Correlates of Renal Venous Flow Patterns across the Heart Failure Spectrum.

Background: We evaluated the bio-humoral and non-invasive haemodynamic correlates of renal congestion evaluated by Doppler renal venous flow (RVF) across the heart failure (HF) spectrum, from asymptomatic subjects with cardiovascular risk factors (Stage A) and structural heart disease (Stage B) to patients with clinically overt HF (Stage C). Methods: Ultrasound evaluation, including echocardiography, lung ultrasound and RVF, along with blood and urine sampling, was performed in 304 patients. Results: Continuous RVF was observed in 230 patients (76%), while discontinuous RVF (dRVF) was observed in 74 (24%): 39 patients had pulsatile RVF, 18 had biphasic RVF and 17 had monophasic RVF. Stage C HF was significantly more common among patients with dRVF. Monophasic RVF was associated with worse renal function and a higher urinary albumin-to-creatinine ratio (uACR). After adjusting for hypertension, diabetes mellitus, the presence of Stage C HF and serum creatinine levels, worsening RVF patterns were associated with higher NT-proBNP levels, worse right ventricular-arterial coupling, larger inferior vena cava and higher echo-derived pulmonary artery wedge pressure. This trend was confirmed when only patients with HF Stage C were analysed after adjusting for the left ventricle ejection fraction (LVEF). Conclusion: Abnormal RVF is common across the HF spectrum. Worsening RVF patterns are independently associated with increased congestion, worse non-invasive haemodynamics and impaired RV-arterial coupling. RVF evaluation could refine prognostic stratification across the HF spectrum, irrespective of LVEF.

Clinical outcomes and predictors in patients with previous cardiac surgery undergoing mitral valve transcatheter edge-to-edge repair.

BACKGROUND: Mitral-valve transcatheter edge-to-edge repair (MV-TEER) is recommended in patients with severe functional mitral regurgitation (FMR) and in those with degenerative mitral regurgitation (DMR) not eligible to traditional surgery. Patients with a history of previous cardiac surgery are considered at high risk for surgical reintervention, but data are lacking regarding procedural and clinical outcomes. OBJECTIVE: aim of this study was to assess the efficacy and clinical results of MV-TEER in patients with previous cardiac surgery enrolled in the "multicentre Italian Society of Interventional Cardiology registry of transcatheter treatment of mitral valve regurgitation" (GIOTTO). METHODS: Patients with previous coronary artery bypass grafting (CABG), surgical aortic valve replacement (AVR), or mitral valve repair (MVR) were included. Those with multiple or combined previous cardiac surgeries were excluded. Clinical follow-up was performed at 30 days, 1 year, and 2 years. The primary endpoint was a composite of death or rehospitalization at 1- and 2-year follow-ups. RESULTS: A total of 330 patients enrolled in the GIOTTO registry were considered (CABG 77.9%, AVR 14.2%, and MVR 7.9%). Most patients showed FMR (66.9%), moderate reduction of left ventricular (LV) ejection fraction, and signs of LV dilation. Procedural and device successes were 94.8% and 97%. At 1 and 2 years, the composite endpoint occurred are 29.1% and 52.4%, respectively. The composite outcome rates were similar across the three subgroups of previous cardiac surgery (p = 0.928) and between the FMR and DMR subgroups (p = 0.850) at 2 years. In a multivariate analysis, residual mitral regurgitation (rMR) ≥2+ was the main predictor of adverse events at 1 year (hazard ratio: 1.54 [95% confidence interval, CI: 1.00-2.38]; p = 0.050). This association was confirmed at 2 years of Kaplan-Meier analysis (p = 0.001). CONCLUSIONS: MV-TEER is effective in these patients, regardless of the subtype of previous cardiac surgery and the MR etiology. An rMR ≥2+ is independently associated with adverse outcomes at 1-year follow-up.

Predictors of optimal procedural result after transcatheter edge-to-edge mitral valve repair in secondary mitral regurgitation.

BACKGROUND: Procedural success after transcatheter edge-to-edge mitral valve repair (TEER) is defined as a reduction of mitral regurgitation (MR) degree to

Long-term clinical outcome and performance of transcatheter aortic valve replacement with a self-expandable bioprosthesis.

AIMS: In the last decade, transcatheter aortic valve (TAV) replacement determined a paradigm shift in the treatment of patients with severe symptomatic aortic stenosis. Data on long-term TAV performance are still limited. We sought to evaluate the clinical and haemodynamic outcomes of the CoreValve self-expandable valve up to 8-year follow-up (FU). METHODS AND RESULTS: Nine hundred and ninety inoperable or high-risk patients were treated with the CoreValve TAV in eight Italian Centres from June 2007 to December 2011. The median FU was 4.4 years (interquartile range 1.4-6.7 years). Longest FU reached 11 years. A total of 728 died within 8-year FU (78.3% mortality from Kaplan-Meier curve analysis). A significant functional improvement was observed in the majority of patients and maintained over time, with 79.3% of surviving patients still classified New York Heart Association class ≤ II at 8 years. Echocardiographic data showed that the mean transprosthetic aortic gradient remained substantially unchanged (9 ± 4 mmHg at discharge, 9 ± 5 mmHg at 8 years, P = 0.495). The rate of Grade 0/1 paravalvular leak was consistent during FU with no significant change from post-procedure to FU ≥5 years in paired analysis (P = 0.164). Structural valve deterioration (SVD) and late bioprosthetic valve failure (BVF) were defined according to a modification of the 2017 EAPCI/ESC/EACTS criteria. In cumulative incidence functions at 8 years, moderate and severe SVD were 3.0% [95% confidence interval (CI) 2.1-4.3%] and 1.6% (95% CI 0.6-3.9%), respectively, while late BVF was 2.5% (95% CI 1.2-5%). CONCLUSION: While TAVs are questioned about long-term performance and durability, the results of the present research provide reassuring 8-year evidence on the CoreValve first-generation self-expandable bioprosthesis.

Interaction between severe chronic kidney disease and acute kidney injury in predicting mortality after transcatheter aortic valve implantation: Insights from the Italian Clinical Service Project.

AIMS: We aim at exploring whether severe chronic kidney disease (CKD) may modify the impact of acute kidney injury (AKI) post-transcatheter aortic valve implantation (TAVI) on early, mid, and long-term mortality. METHODS AND RESULTS: The analysis included 2,733 TAVI patients from the Italian Clinical Service Project. The population was stratified in four groups according to the presence of baseline severe CKD and postprocedural AKI. All-cause mortality was the primary end point. Postprocedural AKI is associated with an increased risk of early and mid-term mortality after TAVI regardless of baseline severe CKD. Preprocedural severe CKD is associated with an increased risk of long-term mortality after TAVI regardless of postprocedural AKI. No interaction between preprocedural severe CKD and postprocedural AKI was observed in predicting mortality at both 30-day (CKD: hazard ratio [HR] = 2.65, 95% confidence interval [CI] = 1.15-6.12; no-CKD: HR = 3.83, 95% CI = 2.23-6.58; Pint = .129) and 1-year (CKD: HR = 2.29, 95% CI = 1.37-3.82; no-CKD: HR = 2.47, 95% CI = 1.75-3.49; Pint = .386). Preprocedural severe CKD is an independent predictor of postprocedural AKI (HR = 2.17, 95% CI = 1.56-3.03; p < .001) as well as general anesthesia and access alternative to femoral. Among no-AKI patients, those with severe CKD at admission underwent kidney function recovery after TAVI (serum creatinine at baseline 2.24 ± 1.57 mg/dL and at 48-hr 1.80 ± 1.17 mg/dL; p = .003). CONCLUSIONS: Preprocedural severe CKD did not modify the impact of postprocedural AKI in predicting early and mid-term mortality after TAVI. Closely monitoring of serum creatinine and strategies to prevent AKI post-TAVI are needed also in patients without severe CKD at admission.

Five-year clinical outcomes after percutaneous edge-to-edge mitral valve repair: Insights from the multicenter GRASP-IT registry.

Limited evidence is available on 5-year clinical outcomes after percutaneous edge-to-edge mitral valve repair. METHODS: The Getting Reduction of mitrAl inSufficiency by Percutaneous clip implantation in ITaly (GRASP-IT) is a multicenter registry including 304 consecutive patients undergoing Mitraclip between October 2008 and October 2013 at 4 Italian centers. Primary end point (all-cause mortality) and secondary end point (all-cause mortality or heart failure [HF] hospitalization) were evaluated up to 5 years and between 1 and 5 years. RESULTS: Cumulative incidence of the primary and secondary end points at 1, 2, 3, 4, and 5 years were 15.1%, 26.4%, 35.5%, 42.1%, and 47.3% and 29.1%, 41.7%, 49.8%, 56%, and 62.3%, respectively. Landmark analysis between 1 and 5 years showed an incidence of primary and secondary end point of 37.9% and 46.8%, respectively. Five-year event rates were significantly higher in patients with functional ischemic mitral regurgitation (MR) compared to other etiologies. MR recurrence and left ventricular ejection fraction <30% were associated with an increased risk of both primary and secondary end points. EuroSCORE II >5% was associated with an increased risk of 5-year mortality. Ischemic etiology of MR, baseline serum creatinine >1.5 mg/dL, chronic obstructive pulmonary disease, and previous HF hospitalizations were independent predictors of 5-year secondary end point. CONCLUSIONS: At 5-year follow-up after Mitraclip, nearly half of patients died and almost two thirds died or were admitted for HF. MR recurrence, ischemic etiology, high comorbidity burden (ie, EuroSCORE II >5%, chronic obstructive pulmonary disease), and advanced cardiomyopathy (ie, left ventricular ejection fraction <30%, prior HF admission, creatinine >1.5 mg/dL) significantly increase the relative risk of 5-year clinical events.

Survival Advantage of MitraClip® Over Medical Treatment in Patients with Mitral Regurgitation: A Meta-Analysis.

BACKGROUND: The MitraClip® system is a percutaneous treatment for mitral regurgitation (MR) that has shown promising results in patients who are inoperable or at high risk for mitral surgery. Data on the efficacy of the system over optimal medical therapy, above all in patients with functional MR, are scarce. The study aim was to assess the effect of MitraClip on the survival of patients with moderate/severe or severe MR compared to medical therapy, using meta-analytical techniques. METHODS: Independently, reviewers searched electronically for relevant articles based on predefined criteria and end-points. Only articles with a comparison between MitraClip and conservative therapy were included. Standard meta-analysis techniques were used. The primary outcomes were 30-day and one-year mortalities. RESULTS: Five observational reports were included that enrolled a total of 1,271 patients: 720 patients underwent percutaneous mitral valve repair (PMVR) with the MitraClip device, and 551 were managed conservatively. A total of 49 all-cause mortality events was reported at 30 days: 3.05% (22/720) in the PMVR arm, and 4.90% (27/510) in the conservative group, with no significant differences in all-cause mortality (OR 0.64; 95% CI 0.36-1.14). A total of 269 all-cause mortality events at one year was reported: 15.14% (109/720) in the PMVR arm, and 29.04% (160/551) in the conservative group. A significant difference favoring PMVR with the MitraClip system over medical therapy alone was observed (OR 0.44; 95% CI 0.30-0.64, p <0.0001). Neither significance between study heterogeneity (p = 0.18) nor publication bias was detected (p = 0.3). CONCLUSIONS: PMVR with the MitraClip system may be associated with an improvement in one-year survival compared to stand-alone medical management.

Left ventricular stiffness predicts outcome in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.

OBJECTIVES: Assessment of the prognostic role of left ventricular stiffness (LVS) in patients with aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). METHODS: We performed a complete two-dimensional transthoracic echocardiographic study before and after TAVI in patients with severe AS at high surgical risk. In order to assess LVS, we measured LV end-diastolic pressure (EDP) invasively during TAVI and LV end-diastolic volume (EDV) by means of echocardiography. We defined LVS as the EDV indexed by body surface area at an EDP of 20 mm Hg (EDVI20 ). Our aim was to assess the impact of LVS on one-year all-cause mortality after TAVI. RESULTS: One hundred sixty-six patients undergoing TAVI (64% female; mean age 82.7 ± 5.1 years) were enrolled. Seven patients died within the first 30 days after TAVI and 21 within 1 year. Overall follow-up duration was 580 ± 478 days. At multivariate analysis, independent predictors of 1-year all-cause mortality were moderate-to-severe paravalvular leak (PVL; HR 4.7, 95% confidence interval [CI] 1.9-11, P=.0003), female gender (HR 3.5, 95% CI 1.0-12, P=.045), and EDVI20 (HR 0.94, 95% CI 0.90-0.98, P=.015). In particular, patients with higher LVS (EDVI20 ≤48 mL/m2 ) had a 1-year mortality of 26.9% vs 7.4% in patients with lower LVS (EDVI20 >48 mL/m2 ; HR 4.2, 95% CI 1.6-10.6, P=.0007). Patients with higher LVS who developed moderate-to-severe PVL had the worst outcome (incremental chi-square test, P=.014). CONCLUSION: In patients with AS, an increased LVS has a negative prognostic impact. Development of significant PVL in patients with higher LVS had an incremental adverse effect.

Predictors of clinical outcomes after edge-to-edge percutaneous mitral valve repair.

BACKGROUND: There is limited information on the long-term outcomes and prognostic clinical predictors after edge-to-edge transcatheter mitral valve repair with the MitraClip system. METHODS: Consecutive patients with mitral regurgitation (MR) undergoing MitraClip therapy between October 2008 and November 2013 in 4 Italian centers were analyzed. The primary end point of interest was all-cause death. The secondary end point was the composite of all-cause death or rehospitalization for heart failure. RESULTS: A total of 304 patients were included, of which 79% had functional MR and 17% were in New York Heart Association functional class IV. Acute procedural success was obtained in 92% of cases, with no intraprocedural death. The cumulative incidences of all-cause death were 3.4%, 10.8%, and 18.6% at 30 days, 1 year, and 2 years, respectively. The corresponding incidences of the secondary end point were 4.4%, 22.0%, and 39.7%, respectively. In the Cox multivariate model, New York Heart Association functional class IV at baseline and ischemic MR etiology were found to significantly and independently predict both the primary and the secondary end point. A baseline, left ventricular end-systolic volume >110 mL was found to be an independent predictor of the secondary endpoint. Acute procedural success was independently associated with a lower risk of all-cause death and the combination of all-cause death or rehospitalization for heart failure at long-term follow-up. CONCLUSIONS: In a cohort of patients undergoing MitraClip therapy, those presenting at baseline with ischemic functional etiology, severely dilated ventricles, or advanced heart failure and those undergoing unsuccessful procedures carried the worst prognosis.

Sex differences in postprocedural aortic regurgitation and mid-term mortality after transcatheter aortic valve implantation.

BACKGROUND: The impact of female sex on mortality after transcatheter aortic valve implantation (TAVI) is controversial. Post-procedural aortic regurgitation (AR) ≥ 2 has been associated with poor outcomes. Whether sex differences in post-procedural AR ≥ 2 could contribute to a mortality difference between women and men is not known. METHODS: Six hundred fifty-six patients, women (53.1%), men (46.9%), with aortic stenosis underwent TAVI with the CoreValve system (92.8%) or the Edwards SAPIEN valve system (7.2%). AR was graded semiquantitatively as 0 = none, 1 = trivial, 2 = mild, 3 = moderate, and 4 = severe. The incidence of post-procedural AR ≥ 2 was reported. RESULTS: Procedural success was similar in women as compared to men (97.9 vs 96.7%, P = 0.32). Post-procedural AR ≥ 2 occurred less frequently in women than in men (20.9 vs 29.6%, P = 0.01). After a median follow-up of 434 days, all-cause mortality tended to be lower in women than in men (20.7 vs 26.6%, logrank P = 0.10), and was significantly higher in patients with AR ≥ 2 than in those without (34.8 vs 19.7%, logrank P < 0.001). AR ≥ 2 [hazard ratio (HR) 1.73, 95% confidence interval (CI) 1.22-2.43, P = 0.002], but not female sex (P = 0.17) was an independent predictor of all-cause death at multivariable Cox regression. The predictive value of AR ≥ 2 was restricted to men (HR 2.96, P < 0.001 among men; HR 0.86, P = 0.60 among women; P for interaction = 0.002). CONCLUSIONS: Women, as compared to men, present a trend toward lower mortality. A significant lower incidence of post-procedural AR ≥ 2 among women contributes to this finding. Female sex, however, was not a significant independent predictor of death.

Transesophageal echocardiography during MitraClip® procedure.

The percutaneous mitral valve (MV) repair procedure performed with the MitraClip delivery system is increasingly used to treat severe mitral regurgitation in high-risk patients. The treatment involves percutaneous insertion and positioning of a clip between the MV leaflets. Transesophageal echocardiography (TEE) plays a key role in the procedure by providing information regarding clip navigation, clip alignment to the MV coaptation line, transmitral advancement of the system, leaflet grasping, confirmation of valve tissue catching, and assessment of the final result. Real-time 3-dimensional TEE has increasing value in percutaneous MV repair providing high-quality visualization of both the heart and the intravascular devices. Optimal visualization by 3-dimensional TEE is obtained through both the atrial and ventricular aspects. In contrast to MV surgery, where TEE is involved in the prebypass assessment phase and in evaluation of the final repair, TEE is mandatory to guide management during MitraClip repair. Cardiac anesthesiologists may provide assistance to interventional cardiologists during the procedure itself in addition to their anesthetic-related tasks.

Evolving Paradigms in Transcatheter Aortic Valve Replacement: Results from a High-Volume, Single Center Experience.

Given the expanding indications toward younger patients at lower surgical risk, transcatheter aortic valve replacement (TAVR) simplification and streamlining are gaining increasing importance. Patients who underwent TAVR from the year 2015 to 2020 were prospectively enrolled. The patients were divided in time tertiles according to the date of intervention. Data on preprocedural planning, including coronary computed tomography angiography (CCTA), procedures, and outcomes, were compared between the time tertiles. A total of 771 consecutive patients from a single institution were enrolled. We observed a trend toward the use of a fully percutaneous versus surgical approach for the index access, left radial artery versus contralateral femoral artery for the secondary access, and left ventricular pacing on the stiff guidewire versus right ventricular pacing. Immediate device success significantly increased, whereas the length of hospital stay decreased. Overall, approximately 60% of the total study population underwent CCTA instead of coronary angiography, with no adverse events. One-year survival rates significantly improved over time. A simplified TAVR approach was associated with better survival, whereas low baseline functional capacity, preexisting coronary artery disease, renal impairment, periprocedural blood transfusions, and paravalvular leak were related to worse outcomes. In conclusion, our study showed a constant tendency to procedure streamlining and improve procedural success and 1-year outcomes. A strategy based on CCTA allows sparing safely almost half of the preoperative invasive coronary angiography.

Guideline-directed medical therapy assessment in heart failure patients undergoing percutaneous mitral valve repair.

AIMS: Achieving optimized guideline-directed medical therapy (GDMT) is recommended prior to transcatheter mitral valve edge-to-edge repair (M-TEER) for secondary mitral regurgitation (SMR). We aimed to propose and validate an easy-to-use score for assessing the quality of GDMT in patients with heart failure with reduced ejection fraction (HFrEF) undergoing M-TEER. METHODS AND RESULTS: Among the 1641 EuroSMR patients enrolled in the EuroSMR Registry who underwent M-TEER, a total of 1072 patients [median age 74, interquartile range (IQR) 67-79 years, 29% female] had complete data on GDMT and a left ventricular ejection fraction ≤ 40% and were included in the current study. We proposed a GDMT score that considers the dosage levels of three medication classes (angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors, beta-blockers, and mineralocorticoid receptor antagonists), with a maximum score of 12 points indicating optimal GDMT. The primary outcome was all-cause mortality. The median GDMT score was 4 points (IQR 3-6). All three domains of the scoring system were associated with all-cause mortality (P < 0.05 for all). The overall GDMT score was associated with all-cause mortality (hazard ratio 0.90, 95% confidence interval 0.86-0.95 for each 1-point increase in the GDMT score). This association remained significant after adjusting for renal function and co-morbidities. CONCLUSIONS: This study demonstrates the utility of a simple GDMT scoring system for assessing the adequacy of GDMT in HFrEF patients with relevant SMR undergoing M-TEER. The GDMT score has potential applications in guiding the design of future clinical trials and aiding clinical decision-making processes.

Impact of Transcatheter Edge-to-Edge Mitral Valve Repair on Atrial Functional Mitral Regurgitation from the GIOTTO Registry.

Atrial functional mitral regurgitation (aFMR) has a peculiar pathophysiology that may have distinctive outcomes. We investigated the impact of transcatheter edge-to-edge repair in aFMR compared with other FMR etiologies. The GIOTTO (GIse registry Of Transcatheter treatment of MR) is a multicenter, prospective study enrolling patients with symptomatic MR treated with MitraClip up to 2020. We categorized patients with FMR as aFMR, ischemic FMR (iFMR), and nonischemic ventricular FMR (niFMR). The clinical end points were defined according to the Mitral Valve Academic Research Consortium. Of 1,153 patients, 6% had aFMR, 47% iFMR, and 47% niFMR. Patients with aFMR were older, mostly women, and had a higher atrial fibrillation rate. They had better left ventricular ejection fraction and smaller left ventricular volumes, with no difference in mitral effective regurgitant orifice area. The acute device and procedural success rates were similar among the groups. At the longest available follow-up (median 478 days, interquartile range 91 to 741 days), the rate of MR ≥2+ was similar among the groups. Patients with aFMR had a lower rate of cardiovascular death and heart failure than patients with iFMR (hazard ratio [HR] 0.43, p = 0.02) and niFMR (HR 0.45, p = 0.03). The aFMR etiology remained independently associated with the composite outcome, together with postprocedural MR ≤1+ (HR 0.63, p <0.01) and peripheral arteriopathy (HR 1.82, p = 0.003). The results of this GIOTTO subanalysis suggested that aFMR is less prevalent and associated with better outcomes compared with other causes of FMR treated by transcatheter edge-to-edge repair. Postprocedural MR >1+, peripheral vasculopathy, non-aFMR were independent predictors of worse outcomes.

Guideline-Directed Medical Therapy and Survival After TEER for Secondary Mitral Regurgitation With Right Ventricular Impairment.

BACKGROUND: Right ventricular impairment is common among patients undergoing transcatheter edge-to-edge repair for secondary mitral regurgitation (SMR). Adherence to guideline-directed medical therapy (GDMT) for heart failure is poor in these patients. OBJECTIVES: The aim of this study was to evaluate the impact of GDMT on long-term survival in this patient cohort. METHODS: Within the EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) international registry, we selected patients with SMR and right ventricular impairment (tricuspid annular plane systolic excursion ≤17 mm and/or echocardiographic right ventricular-to-pulmonary artery coupling <0.40 mm/mm Hg). Titrated guideline-directed medical therapy (GDMTtit) was defined as a coprescription of 3 drug classes with at least one-half of the target dose at the latest follow-up. The primary outcome was all-cause mortality at 6 years. RESULTS: Among 1,213 patients with SMR and right ventricular impairment, 852 had complete data on medical therapy. The 123 patients who were on GDMTtit showed a significantly higher long-term survival vs the 729 patients not on GDMTtit (61.8% vs 36.0%; P < 0.00001). Propensity score-matched analysis confirmed a significant association between GDMTtit and higher survival (61.0% vs 43.1%; P = 0.018). GDMTtit was an independent predictor of all-cause mortality (HR: 0.61; 95% CI: 0.39-0.93; P = 0.02 for patients on GDMTtit vs those not on GDMTtit). Its association with better outcomes was confirmed among all subgroups analyzed. CONCLUSIONS: In patients with right ventricular impairment undergoing transcatheter edge-to-edge repair for SMR, titration of GDMT to at least one-half of the target dose is associated with a 40% lower risk of all-cause death up to 6 years and should be pursued independent of comorbidities.

Non invasive evaluation of cardiomechanics in patients undergoing MitrClip procedure.

BACKGROUND: In the last recent years a new percutaneous procedure, the MitraClip, has been validated for the treatment of mitral regurgitation. MitraClip procedure is a promising alternative for patients unsuitable for surgery as it reduces the risk of death related to surgery ensuring a similar result. Few data are present in literature about the variation of hemodynamic parameters and ventricular coupling after Mitraclip implantation. METHODS: Hemodynamic data of 18 patients enrolled for MitraClip procedure were retrospectively reviewed and analyzed. Echocardiographic measurements were obtained the day before the procedure (T0) and 21 ± 3 days after the procedure (T1), including evaluation of Ejection Fraction, mitral valve regurgitation severity and mechanism, forward Stroke Volume, left atrial volume, estimated systolic pulmonary pressure, non invasive echocardiographic estimation of single beat ventricular elastance (Es(sb)), arterial elastance (Ea) measured as systolic pressure • 0.9/ Stroke Volume, ventricular arterial coupling (Ea/Es(sb) ratio). Data were expressed as median and interquartile range. Measures obtained before and after the procedure were compared using Wilcoxon non parametric test for paired samples. RESULTS: Mitraclip procedure was effective in reducing regurgitation. We observed an amelioration of echocardiographic parameters with a reduction of estimated systolic pulmonary pressure (45 to 37,5 p = 0,0002) and left atrial volume (110 to 93 p = 0,0001). Despite a few cases decreasing in ejection fraction (37 to 35 p = 0,035), the maintained ventricular arterial coupling after the procedure (P = 0,67) was associated with an increasing in forward stroke volume (60,3 to 78 p = 0,05). CONCLUSION: MitraClip is effective in reducing mitral valve regurgitation and determines an amelioration of hemodynamic parameters with preservation of ventricular arterial coupling.

Advantages of real time three-dimensional echocardiography in the assessment of right ventricular volumes and function in patients with pulmonary hypertension compared with conventional two-dimensional echocardiography.

BACKGROUND: In recent years, right ventricular (RV) function has acquired greater relevance as a clinical and prognostic marker in many physiopathological conditions. The study aims to point out the value of real time three-dimensional echocardiography (RT3DE) and tissue Doppler imaging (TDI) in the evaluation of patients affected by pulmonary hypertension (PH), compared with conventional two-dimensional (2D) echocardiography. METHODS: We enrolled 44 subjects affected by PH who underwent 2D and Doppler echocardiography, RT 3D Echocardiography and TDI evaluation of the RV, and a healthy control group. PH itself can induce severe functional and structural abnormalities of the RV, such as RV hypertrophy, RV dilation, and RV systolic and diastolic dysfunction. RESULTS: In this study, RV FAC, and TAPSE showed marked alterations in patients with PH compared to the control group (C): (RVFAC: [PH] 0.29 ± 0.07 vs. [C] 0.49 ± 0.05%, P < 0.0001; TAPSE: [PH] 15.3 ± 3.2 vs. [C] 21.1 ± 2.6 mm, P > 0.0001). The 3D RV end-diastolic volume was significantly higher in PH than in C (PH) (138.7 ± 25.3 vs. [C] 82.8 ± 12.5 mL, P < 0.0001] as well as 3D RV end-systolic volume (PH) (97.6 ± 21.5 vs. [C] 39.3 ± 9.5 mL, P < 0.0001). The 3D RV ejection fraction (EF) was significantly lower in the pulmonary hypertension group than in healthy subjects (31.8 ± 6.8 vs. [C] 52.5 ± 4.7%, P < 0.0001). CONCLUSIONS: In patients with PH, evaluation of the RV diastolic and systolic volume and EF by RT3DE has shown a higher discriminating power in comparison, respectively, with 2DRV diastolic area and the relative fractional area changes.