Transcatheter Mitral Valve Repair Research Articles

Transcatheter Mitral Valve Repair With MitraClip: Comparison of NT, NTr, and XTr Devices

Transcatheter Mitral Valve Repair With MitraClip: Comparison of NT, NTr, and XTr Devices

Correction to: Healthcare resource utilisation and safety outcomes in patients undergoing transcatheter mitral valve repair - A nationwide analysis.

Correction to: Healthcare resource utilisation and safety outcomes in patients undergoing transcatheter mitral valve repair - A nationwide analysis.

Long-term cost-effectiveness of transcatheter mitral valve repair in HF patients with secondary mitral regurgitation.

The long-term cost-effectiveness of MitraClip in heart failure patients with secondary mitral regurgitation is still unclear. This study aimed to evaluate the long-term cost-effectiveness of MitraClip added to guideline-directed medical therapy vs. guideline-directed medical therapy alone in heart failure patients with secondary mitral regurgitation from the perspective of the healthcare systems of mainland China, the United Kingdom, Germany, and the United States. A two-stage (decision+Markov) model was built. Health utilities were defined by the New York Heart Association class, heart failure re-hospitalization, and death and were calculated based on the 5year follow-up results of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation trial. Direct healthcare costs were derived from the nationally representative data. Future utilities and costs were discounted at country-specific rates. The primary outcome was the lifetime incremental cost-effectiveness ratio. The mean age of the base case in our model was 72.2years. Over a lifetime horizon, treatment with MitraClip was associated with 829 fewer heart failure re-hospitalizations per 1000 treated patients. The MitraClip treatment was associated with incremental quality-adjusted life-year gains of 0.71, 0.76, 0.78, and 0.78, as well as incremental cost-effectiveness ratios of ¥468462, £28910, €26045, and $71199 per quality-adjusted life-year for a lifetime horizon in mainland China, the United Kingdom, Germany, and the United States, respectively. In probabilistic sensitivity analysis, 0.2%, 59.4%, 99.6%, and 84.7% of patients were cost-effective in mainland China, the United Kingdom, Germany, and the United States at the country-specific willingness-to-pay thresholds. MitraClip+guideline-directed medical therapy was cost-effective in heart failure patients with secondary mitral regurgitation in the United Kingdom, Germany, and the United States, but not in mainland China from the perspective of the national healthcare system.

Etiologies and Impact of Exclusion Rates for Transcatheter Mitral and Tricuspid Valve Structural Heart Clinical Trials at a High-Volume Quaternary Care Hospital

There are various devices under clinical investigation for transcatheter mitral valve intervention (TMVI) and tricuspid valve intervention (TTVI), but exclusion rates remain high. We aim to investigate exclusion rates for transcatheter mitral valve repair (TMVr), transcatheter mitral valve replacement (TMVR), transcatheter tricuspid valve repair (TTVr) and transcatheter tricuspid valve replacement (TTVR). There were a total of 129 patients who were referred to St. Francis Hospital & Heart Center valve clinic and completed screening between January 2021 and July 2022. Causes for exclusion were classified into 4 categories: patient withdrawal, anatomic unsuitability, clinical criteria and medical futility. Among 129 patients, the exclusion rates for TMVr, TMVR, TTVr and TTVR were 81%, 85%, 91% and 87%, respectively. Patient withdrawal and medical futility were leading etiologies for exclusion, followed by anatomical unsuitability. TMVr had the highest rate of patient withdrawal (64%), the lowest anatomic unsuitability (5%) due to short posterior leaflet length. Replacement interventions have higher anatomic unsuitability (33%) compared to repair interventions (17%) (p=0.04). Most exclusions of anatomic unsuitability was due to mitral stenosis or small annulus size for TMVR and large annulus size for TTVR. Fifty percent of exclusions from TTVr were due to presence of pacemaker/defibrillator leads. Among patients excluded from their respective trials, patients being referred for TMVr had the highest recurrent hospitalization and repair group had a higher mortality (p<0.01 and p=0.01, respectively). In conclusion, exclusion rates for TMVI and TTVI trials remain high due to various reasons, limiting patients’ enrollment and treatment. This supports the need for further device improvement or exploring alternative means of therapy.

Outcomes of COMBO therapy for severe mitral regurgitation compared with transcatheter edge-to-edge repair.

There are different types of transcatheter mitral valve repair (TMVr) currently in clinical use, including leaflet approximation, annular cinching, and restoration of the chordal apparatus of the mitral valve (MV). While the concomitant combination (COMBO) therapy of mitral transcatheter edge-to-edge repair (M-TEER) with another TMVr concept has been proven feasible, potentially offering patient-tailored treatment for severe mitral regurgitation (MR), a comparison with M-TEER alone has not been made. To evaluate the procedural and clinical outcome of COMBO therapies compared with M-TEER alone. We included consecutive patients undergoing COMBO and M-TEER between March 2015 and April 2018 at our Heart Valve Center, while excluding patients presenting a case of redo or with previous MV surgery. Procedural outcomes and all-cause mortality were compared between COMBO therapy vs. M-TEER alone. A total of 357 patients (mean age 78.9 ± 7.0 years, 53.2% male, M-TEER n = 322, COMBO n = 35; COMBO: MitraClip and the Carillon mitral contour system n = 26, MitraClip and Cardioband n = 5, and MitraClip and NeoChord n = 4) were analyzed. Patients with COMBO therapy had larger left chamber sizes, a lower left ventricular systolic ejection fraction (LVEF; COMBO: 37.4 ± 13.8%, M-TEER: 47.9 ± 14.3%, p < 0.001), and a more severe MR grade (p < 0.001). There were no significant differences in the prevalence of residual MR ≧2+. However, the need for re-intervention, always employing M-TEER, was more common in the COMBO group. During a mean 3.6-year long-term follow-up, there was no significant difference of all-cause mortality between both groups (Log rank p = 0.921). COMBO therapy may still be a beneficial therapy option for patients with severe MR who already have a more dilated left ventricle (LV), a more severe MR, and a more pronounced LV systolic dysfunction. The higher need for re-intervention in the COMBO group may signal more complex anatomies and possibly underlines the necessity of treating significant MR earlier. Future research is required to establish the COMBO approach as a toolbox-like treatment option, thus offering a patient-tailored approach depending on the individual anatomy and pathology.

Frailty, periinterventional complications and outcome in patients undergoing percutaneous mitral and tricuspid valve repair.

Frailty is common in elderly and multimorbid patients and associated with increased vulnerability to stressors. In a single centre study frailty according to Fried criteria was assessed in consecutive patients before transcatheter mitral and tricuspid valve repair. Postprocedural infections, blood transfusion and bleeding and renal failure were retrospectively assessed from records. Median follow-up time for survival was 560 days (IQR: 363 to 730 days). 90% of 626 patients underwent mitral valve repair, 5% tricuspid valve repair, and 5% simultaneous mitral and tricuspid valve repair. 47% were classified as frail. Frailty was associated with a significantly increased frequency of bleeding (16 vs 10%; p = 0.016), blood transfusions (9 vs 3%; p =  < 0.001) and infections (18 vs 10%; p = 0.006), but not with acute kidney injury (20 vs 20%; p = 1.00). Bleeding and infections were associated with longer hospital stays, with a more pronounced effect in frail patients (interaction test p < 0.05, additional 3.2 and 4.1 days in frail patients, respectively). Adjustment for the occurrence of complications did not attenuate the increased risk of mortality associated with frailty (HR 2.24 [95% CI 1.62-3.10]; p < 0.001). Bleeding complications and infections were more frequent in frail patients undergoing transcatheter mitral and tricuspid valve repair and partly explained the longer hospital stay. Albeit some of the complications were associated with higher long-term mortality, this did not explain the strong association between frailty and mortality. Further research is warranted to explore interventions targeting periprocedural complications to improve outcomes in this vulnerable population.

A Comparative Study of 1-Year Postprocedural Outcomes in Transcatheter Mitral Valve Repair in Advanced Primary Mitral Regurgitation: PASCAL vs. MitraClip.

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) ≥0.40 cm2 or large flail gap (≥5 mm) or width (≥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 ≤ 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.

Economic Burden of Inpatient Care for Mitral Regurgitation in Maryland.

Mitral regurgitation (MR) is the most common valvular disease in the United States and increases the risk of death and hospitalization. The economic burden of MR in the United States is not known. We analyzed inpatient hospitalization data from the 1 221 173 Maryland residents who had any in-state admissions from October 1, 2015, to September 30, 2019. We assessed the total charges for patients without MR and for patients with MR who underwent medical management, transcatheter mitral valve repair or replacement, or surgical mitral valve repair or replacement. During the study period, 26 076 inpatients had a diagnosis of MR. Compared with patients without MR, these patients had more comorbidities and higher inpatient mortality. Patients with medically managed MR incurred average total charges of $23 575 per year; MR was associated with $10 559 more in charges per year and an incremental 3.1 more inpatient days per year as compared with patients without MR. Both surgical mitral valve repair or replacement and transcatheter mitral valve repair or replacement were associated with higher charges as compared with medical management during the year of intervention ($47 943 for surgical mitral valve repair or replacement and $63 108 for transcatheter mitral valve repair or replacement). Annual charges for both groups were significantly lower as compared with medical management in the second and third years postintervention. MR is associated with higher mortality and inpatient charges. Patients who undergo surgical or transcatheter intervention incur lower charges compared with medically managed MR patients in the years after the procedure.

The Results of Urgent and Emergent Transcatheter Mitral Valve Repair (MitraClip®): A Comparison with Standard Elective Repair

Background: Mitral regurgitation (MR) is the most common valvular disease worldwide. MR has been managed surgically, with either a mitral valve replacement or repair. Percutaneous transcatheter mitral valve repair (TMVr) with MitraClip® insertion has gained wide popularity and success over medical and surgical therapy for MR. Some patients with acute MR or decompensated heart failure could benefit from urgent TMVr. This meta-analysis aims to compare clinical outcomes of urgent versus elective TMVr. Methods: We performed a study-level meta-analysis to compare the clinical outcomes of urgent versus elective TMVr using the MitraClip system. The primary endpoint outcome was all-cause mortality. Additional outcomes included procedural success, postoperative acute kidney injury (AKI), stroke, and length of in-hospital stay. Results: Overall, 30-day mortality was significantly higher in the urgent group (odds ratio [OR]: 2.74; 95% confidence interval [CI] [2.17, 3.48]; P &lt; 0.00001; I² =0%). However, subgroup analysis of matched cohorts showed no significant difference between both groups (OR: 1.80; 95% CI [0.94, 3.46]; P = 0.08; I² =0%). One-year mortality was similar between both groups (and: 1.67; 95% CI [0.96, 2.90]; P = 0.07; I² =0%). Procedural success was similar between both groups (89.4% vs. 89.8%; P = 0.43). Postoperative AKI was significantly higher in the urgent group (OR: 4.12; 95% CI [2.87, 5.91]; P &lt; 0.00001; I² =0%). Conclusion: Urgent TMVr should be indicated in select populations as it is considered therapeutic with acceptable outcomes therein.

Mortality Associated With Proportionality of Secondary Mitral Regurgitation After Transcatheter Mitral Valve Repair: North American Mitraclip for Functional Mitral Regurgitation Registry

The association, if any, between the effective regurgitant orifice area (EROA) to left ventricular end-diastolic volume (LVEDV) ratio and 1-year mortality is controversial in patients who undergo mitral transcatheter edge-to-edge repair (m-TEER) with the MitraClip system (Abbott Vascular, Santa Clara, CA). This study's objective was to determine the association between EROA/LVEDV and 1-year mortality in patients who undergo m-TEER with MitraClip. In patients with severe secondary (functional) mitral regurgitation (MR), we analyzed registry data from 11 centers using generalized linear models with the generalized estimating equations approach. We studied 525 patients with secondary MR who underwent m-TEER. Most patients were male (63%) and were New York Heart Association class III (61%) or IV (21%). Mitral regurgitation was caused by ischemic cardiomyopathy in 51% of patients. EROA/LVEDV values varied widely, with median=0.19 mm2/ml, interquartile range [0.12,0.28] mm2/ml, and 187 patients (36%) had values <0.15 mm2/ml. Postprocedural mitral regurgitation severity was substantially alleviated, being 1+ or less in 74%, 2+ in 20%, 3+ in 4%, and 4+ in 2%; 1-year mortality was 22%. After adjustment for confounders, the logarithmic transformation (Ln) of EROA/LVEDV was associated with 1-year mortality (odds ratio 0.600, 95% confidence interval 0.386 to 0.933, p=0.023). A higher Society of Thoracic Surgeons risk score was also associated with increased mortality. In conclusion, lower values of Ln(EROA/LVEDV) were associated with increased 1-year mortality in this multicenter registry. The slope of the association is steep at low values but gradually flattens as Ln(EROA/LVEDV) increases.

Preprocedural Controlling Nutritional Status Score as a Predictor of Mortality in Patients Undergoing Transcatheter Mitral Valve Repair　― A Single Center Experience in Japan ―

Preprocedural Controlling Nutritional Status Score as a Predictor of Mortality in Patients Undergoing Transcatheter Mitral Valve Repair　― A Single Center Experience in Japan ―

The Prevalence and Impact of Obesity on the Outcomes of Patients Undergoing Transcatheter Mitral Valve Repair using MitraClip - A National Inpatient Sample Analysis 2016 to 2020.

The Prevalence and Impact of Obesity on the Outcomes of Patients Undergoing Transcatheter Mitral Valve Repair using MitraClip - A National Inpatient Sample Analysis 2016 to 2020.

Transcatheter versus surgical mitral valve repair in patients with mitral regurgitation.

The aim of this study was to compare clinical outcomes of transcatheter and surgical mitral valve repair (SMVr) in primary mitral regurgitation (MR) and MR with heart failure with reduced ejection fraction (HFrEF). In this retrospective cohort study, we used the Nationwide Readmission Database to identify primary MR and MR with HFrEF patients who underwent transcatheter or SMVr from 2016 to 2019. A propensity score with 1:1 matching was applied. The primary outcome was a cumulative event rate of major adverse cardiovascular events (MACE), which was a composite of all-cause mortality, myocardial infarction, stroke, heart failure, cardiac arrest and mitral valve replacement. Other important secondary outcome was in-hospital mortality. After propensity score matching, 2187 matched pairs were found in the primary MR cohort and 2178 matched pairs were found in the MR-HFrEF cohort. Transcatheter mitral valve repair (TMVr) had significantly higher medium-term MACE compared with SMVr in both cohorts (primary MR: hazard ratio: 1.73, 95% confidence interval: 1.33-2.26, P ≤ 0.001; MR-HFrEF: hazard ratio: 2.00, 95% confidence interval: 1.58-2.54, P ≤ 0.001). TMVr showed similar in-hospital mortality in both cohorts. Although TMVr showed better short-term outcomes, it had significantly higher medium-term MACE than SMVr in both cohorts. Thus, shared decision-making should be performed for TMVr after discussing the benefits and risks in patients who can undergo SMVr.

Thirty-day Outcomes of First-in-man Implantation of a Novel Transcatheter Edge-to-edge Mitral Repair System in Patients with Severe Mitral Regurgitation

Objectives: The aim of this multicenter, prospective, single-arm pilot study (ClinicalTrials.gov number: NCT05040074) was to observe the procedural and 30-day results of the novel transcatheter mitral valve repair system, SQ-Kyrin®-M Clip (Shenqi Medical, Shanghai, China), in patients with severe mitral regurgitation (MR). Methods: The heart team considered patients from 5 centers in China with clinically significant functional mitral regurgitation ≥3+ despite optimal medical therapy or degenerative mitral regurgitation ≥3+ with high surgical risk as candidates for transcatheter repair. All patients received transcatheter edge-to-edge mitral valve repair under general anesthesia. The primary outcome was technical success, which included all of the following measured at the exit from the catheterization laboratory: (1) absence of procedural mortality; (2) successful access, delivery, and retrieval of the device delivery system; (3) successful deployment and correct positioning of the first intended device; and (4) no emergency surgery or reintervention related to the device or access procedure. The secondary outcomes included all-cause mortality, serious adverse events, device success, and procedural success 30 d after the intervention. Results: From June 2021 to December 2021, 18 patients were enrolled in this study with age (75.7 ± 7.4) years. Fifteen (83.3%) patients had MR 4+, while 3 (16.7%) had MR 3+. Technical success was achieved in all patients, including 6 degenerative mitral regurgitation and 12 functional mitral regurgitation patients. There was no all-cause mortality at 30 d. One (5.6%) patient had single leaflet device attachment within 30 d, which was regarded as a serious adverse event, and the patient was successfully treated with reintervention by implanting another clip. Another patient’s transmitral gradient was 6 mmHg (&gt;5 mmHg), with an effective orifice area of 2.57 cm2 after the procedure. Sixteen (88.9%) patients had device success and procedural success at 30 d postoperation. Fourteen (77.8%) patients had MR 1+, 3 (16.7%) had MR 2+, and only 1 (5.6%) patient had MR 3 + 30 d after the procedure. Conclusions: The results of this feasibility study showed the efficacy and safety of the SQ-Kyrin®-M device in the Chinese population with severe MR, laying a solid foundation for a subsequent large-scale confirmatory study.

Investigating the impact of chronic heart failure on in-hospital outcomes following transcatheter mitral valve repair or replacement: a national inpatient sample study (2016-2020)

Abstract Background Chronic heart failure (CHF) is a global health problem and one of the primary causes of morbidity and mortality worldwide. Transcatheter mitral valve repair or replacement (TMVr or TMVR) is a procedure that has demonstrated improved outcomes in patients with severe mitral valve disease. However, the impact of CHF on in-hospital outcomes following TMVR or TMVr remains unclear. Methods In this retrospective cohort study, we utilized the United States National Inpatient Sample database from 2016 to 2020. We identified patients who underwent TMVR or TMVr using ICD-10 codes and stratified them based on the presence or absence of CHF diagnosis. We assessed in-hospital complications, length of stay, and cost of care as primary and secondary outcomes. We performed multivariate logistic regression analysis to control for potential confounders. Results Our study included 48,885 patients who underwent TMVR or TMVr, of which 16,132 (33%) had a diagnosis of CHF. The cohort was predominantly male (54%) with a mean age of 76 years. Compared to patients without CHF who underwent TMVR/TMVr, those with CHF had lower rates of in-hospital mortality, valvular complications, cardiogenic shock, vascular complications, bleeding, blood transfusions, respiratory failure, acute kidney injury, and acute myocardial infarction (see Figure 1). Additionally, patients with CHF had a reduced length of stay (coefficient -3.48; p &amp;lt;0.001) and cost of care (coefficient -$58749.37; p &amp;lt;0.001). However, there were no significant differences in rates of pericardial tamponade, intracranial hemorrhage, or ischemic strokes. Conclusions Our findings suggest that patients with chronic heart failure (CHF) who underwent transcatheter mitral valve repair or replacement (TMVr or TMVR) had better in-hospital outcomes compared to those without CHF. This may be due to a protective effect of the chronic disease, where compensatory mechanisms developed by the body may help patients with CHF better tolerate the procedure and have decreased in-hospital complications. These results highlight the importance of further investigating the role of CHF in TMVr/TMVR outcomes and tailoring patient selection for these procedures.

Efficacy and evolution of edge-to-edge transcatheter valve repair procedures

Abstract Background Edge-to-edge transcatheter mitral valve repair (M-TEER) has shown safety and efficacy in reducing secondary mitral regurgitation (MR) (1,2) and led to the development of similar devices for transcatheter valve repair (T-TEER) for tricuspid regurgitation (TR) (Fig. 1A). However, T-TEER implementation is challenging due to complex valve anatomy and periprocedural imaging. We sought to understand to which extent procedural success of M-TEER changed over time and possibly impacted T-TEER results. Methods We retrospectively analyzed intraprocedural reduction of secondary MR and TR after release of a valve specific device, between 2018, when M-TEER was implemented in our center, through 2020, when T-TEER procedures started, and up to the end of 2022. We compared results between the 55 T-TEER procedures performed (age 81.8±4.7, 55% females) and 3 M-TEER cohorts: the very first 55 M-TEER, the last 55 M-TEER before T-TEER, and the very last 55 M-TEER (overall mean-age 78.4±8.2, 49% females) (Fig. 1B). Severe MR III/IV was defined by an effective regurgitation orifice area (EROA) of 20-39mm², and IV/IV by EROA ≥40mm², while TR was evaluated using the I/V to V/V classification. Considering that a 5-grade reduction of TR is either not possible or not desirable, the extension of regurgitation reduction for both valves was set on a scale from 1- to 4-grade. Also, optimal results were defined as residual MR 0+ (none or trace) or TR I+ (mild or mild to moderate), while acceptable results were considered MR I+ and TR II+ (moderate or moderate to severe). Results In all groups, regurgitation was successfully and significantly reduced within-group (Fig. 1C). MR reduction to optimal or acceptable levels increased over time from 60% at the start of the M-TEER program to 78% after 12-18 months (p=0.039), and 84% (p=0.005) after approximately 3 years. Accordingly, the extent of regurgitation reduction significantly improved between the first 2 M-TEER cohorts (p=0.016), as well as the first and the last 55 M-TEER (p=0.045), with no significant change from the second to the third population (p=0.267) (Fig. 2). Two years after the first M-TEER, T-TEER with valve specific devices was implemented and achieved 84% optimal or acceptable residual TR, better than initial M-TEER (p=0.005) and similar to the second (p=0.466) and third M-TEER cohorts (p=1.000). In terms of extent of regurgitation reduction, T-TEER also performed similar to the very first (p=0.645) and the very last M-TEER procedures (p=0.076), despite higher mean-EROA (78.5±32.2mm² vs 44.8±16.1mm² in all MR patients, p&amp;lt;0.001), more complex anatomy, more challenging imaging, and sicker patients (mean-EuroSCORE II 8.8±6.6% vs 6.4±5.3% in all MR patients, p&amp;lt;0.001). Conclusions In our center, gain in knowledge and experience, coupled with technological advances, have significantly impacted procedural M-TEER success over time and allowed similar successful implementation of a T-TEER program.Figure 1Figure 2

Healthcare resource utilisation and safety outcomes in patients undergoing transcatheter mitral valve repair - A nationwide analysis

Abstract Background Since the publication of the EVEREST II, MITRA-FR and COAPT trials, the domain of transcatheter edge-to-edge repair (TEER) for mitral regurgitation has been rapidly progressing. However, real-world data on peri-procedural outcomes are still limited. Purpose To analyse outcomes of peri-procedural healthcare resource utilisation and in-hospital safety after TEER between 2016 and 2019 in the United States. Methods The US National Inpatient Sample was utilised to identify adult patients undergoing TEER. Primary outcomes (hospital resource utilisation) were hospital length of stay (LOS), hospital costs and adverse discharge disposition to a nursing or rehabilitation facility. Secondary outcomes (safety) were in-hospital mortality, post-procedural bleedings, vascular complications, ischemic strokes, cardiogenic shocks, cardiac arrests and pericardial tamponades. Multivariable regression models were used to analyse outcomes. Results 4,020 adult patients undergoing a TEER procedure were included. The included population was relatively frail: average age of 78.1 years (±9.7), average Charlson Comorbidity Index of 3 [IQR 1-4], average number of cardiovascular risk factors of 3 [2-4] per patient, average CHA2DS2-VASc score of 4 [3-5] and average simplified HAS-BLED score of 2 [2-3]. Distribution of the procedure was balanced between both sexes: 2,159 (53.7%) males vs. 1,861 (46.3%) females. Procedures were predominantly performed in large hospitals with 3,052 cases (75.9%), as well as in regional "hubs" at both US coastal regions with 543 cases (13.5%) in the Middle Atlantic region, 832 cases (20.7%) in the South Atlantic region, 535 cases (13.3%) in the East North Central region and 690 cases (17.2%) in the Pacific region. TEER procedure showed relatively save outcomes: 34 in-hospital deaths (0.8%), 119 (3.0%) post-procedural bleedings, 1 vascular complication requiring surgery, 24 (0.6%) ischemic strokes, 64 (1.6%) cardiogenic shocks, 20 (0.5%) cardiac arrests and 13 (0.3%) pericardial tamponades. Between 2016 and 2019, hospital LOS decreased by 22% [95% Confidence Interval (CI) 0.73-0.83], hospital costs by 6% [95% CI 0.90-0.98] and post-procedural discharge rates to a nursing or rehabilitation facility by 40% [95% CI 0.41-0.88]; each P&amp;lt;0.001 (Figure). Post-procedural bleedings and cardiac arrests were reduced by 55% [95% CI 0.27-0.76] and 87% [95% CI 0.02-0.61] during the study period, respectively. In-hospital mortality, ischemic stroke, cardiogenic shock and pericardial tamponade decreased numerically but were not statistically significant (due to low overall event rates). Of note, there was a linear increase in all adverse outcomes with increasing patient comorbidity level (P for trend &amp;lt;0.001), particularly in patients with atrial fibrillation or flutter. Conclusion TEER procedure has become a safer and more efficient procedure. Careful considerations should be taken when performing the procedure in patients with multiple comorbidities.

Transcatheter mitral valve repair and its impact on reverse right ventricular remodelling

Abstract Introduction Transcatheter edge-to-edge repair (TEER) has been proven to reduce cardiovascular events in a particular subset of patients with severe mitral insufficiency (MR) and left ventricle dysfunction. Nevertheless, its short and long-term impact on the right ventricle (RV) remained to be determined. Our goal was to assess the effect of TEER on the RV and right chamber pressures. Methods Patients were consecutively enrolled from Nov 2018 to Jul 2022. Clinical, laboratory echocardiographic and procedural data were collected. Follow-up information of admissions for heart failure, New York Heart Association (NYHA) functional class and survival was collected. The data was analysed prior to and at 3 and 12 months after the procedure. RV dysfunction was defined as Tricuspid Annular Plane Systolic Excursion (TAPSE) &amp;lt; 17mm or S’ &amp;lt; 9cm/s. Changes between baseline and follow-up parameters were assessed using the paired t-test. Results A total of 46 patients were included. Average age was 77.28 ± 7.92 years and 30 were male (65.2%). Twelve patients were on NYHA class III (26.1%) and most had functional mitral insufficiency (25; 54.3%) and mild to moderate tricuspid insufficiency (36; 78.3%). All patients had severe mitral insufficiency (estimated regurgitant orifice area 41.28 ± 16.77mm; regurgitant volume 62 ± 28.96mL). Seventeen patients had diabetes (37.0%), 10 had coronary artery disease (21.7%), 23 had atrial fibrillation (50.0%) and 6 had chronic kidney disease (13.0%). At 3 months, mean right ventricular/right atrial gradient (RV/RAgrad) was significantly lower (37.26 ± 9.66 mmHg vs 30.81 ± 17.36 mmHg; p 0.017) as well as MR (2.98 ± 0.15 vs 1.67 ± 0.63; p &amp;lt; 0.001). There were no differences regarding severity of tricuspid regurgitation (TR) and RV and left ventricle (LV) function. At 1 year follow-up there was a marked improvement of RV/RAgrad (37.49 ± 10.87 mmHg vs 28.12 ± 10.13 mmHg; p 0.009), TAPSE (18.83 ± 4.22 mm vs 20.88 ± 3.08 mm; p 0.035), S’ (10.81 ± 4.00 cm/s vs 13.5 ± 1.97 cm/s, p 0.015) and MR severity (2.98 ± 0.15 vs 1.83 ± 0.71; p &amp;lt;0.001). Number of heart failure readmissions was also lower at 1 year follow-up post TEER (0.35 ± 0.80 vs 0.81 ± 0.87; p 0.032). Over a mean follow-up time of 1.72 ± 1.16 years, only 8.7% of patients died and 17.4% were readmitted due to heart failure. Conclusion TEER has a positive impact on right ventricle function and pressures. This effect was more prominent at 1 year follow-up and suggests reverse remodelling continues even after 3 months. Overall, patients with TEER had low rates of death and heart failure readmissions.

Heart failure medical therapy and outcomes in patients undergoing transcatheter mitral valve repair for secondary mitral regurgitation: a TVT Registry analysis across 449 US centers

Abstract Background Guidelines recommend medical therapy optimization prior to transcatheter mitral valve repair (TMVr) in patients with heart failure (HF), left ventricular ejection fraction (LVEF) &amp;lt;50%, and severe secondary mitral regurgitation (SMR). Whether TMVr is being performed on the background of optimal guideline directed medical therapy (GDMT) in clinical practice is unknown. Purpose To assess pre-procedure GDMT (B-blockers, ACEI [angiotensin converting enzyme inhibitor]/ARB [angiotensin receptor blocker], ARNI [angiotensin receptor neprilysin inhibitor], MRA [mineralocorticoid receptor antagonist]) use and association with outcomes in patients with HF and LVEF &amp;lt;50% undergoing TMVr. Methods Patients with LVEF &amp;lt;50% who underwent TMVr for SMR from July 2019 – March 2022 in the Transcatheter Valve Therapy Registry were identified. Patients on inotropes or in shock pre-TMVr were excluded. Cox proportional hazards models were constructed to evaluate adjusted associations between pre-TMVr medical therapy (no, single, double, or triple therapy) and risk of the one-year composite outcome of mortality or HF hospitalization. Sensitivity analyses excluded patients with HF with mildly reduced ejection fraction (HFmrEF) (LVEF &amp;gt;40%) or New York Heart Association (NYHA) class I (asymptomatic) prior to TMVr. Results A total of 4,199 patients across 449 sites were identified. Prior to TMVr, B-blockers (85.1%) were prescribed most frequently, followed by ACEI/ARB (44.4%), MRA (28.6%), and ARNI (19.9%). Triple therapy was prescribed for 19.2% of patients, while 38.2% were on double therapy, 36.0% were on single therapy, and 6.5% were on no medical therapy. Triple therapy use varied from 0 - 61% across sites with an adjusted median odds ratio of 1.48 (95% confidence interval [CI] 1.25-3.88, P&amp;lt;0.001), suggesting a 1.5-fold variation in the likelihood that similar risk patients at 2 random US sites received triple therapy pre-TMVr (Figure 1). In patients with one-year follow-up available (n=2,014, 341 sites), the composite rate of one-year mortality or HF hospitalization was lowest in patients on triple therapy (23.1%) compared with double (24.8%), single (35.7%), and no (41.1%) therapy (P≤0.01). Associations persisted after accounting for clinically relevant covariates, with lower risk in patients on triple therapy (adjusted hazard ratio [aHR] 0.73, 95% CI 0.55-0.97) and double therapy (aHR 0.60, 95% CI 0.50-0.74) prior to TMVr compared with no/single therapy. Results were similar when only patients with symptomatic HFrEF were considered (i.e., those with HFmrEF or NYHA class I pre-TMVr were excluded) (Figure 2). Conclusions Under one-fifth of patients who underwent TMVr for SMR were prescribed comprehensive GDMT, with substantial variation across clinical sites. Compared with no or single therapy, triple and double therapy use prior to TMVr was independently associated with reduced risk of mortality or HF hospitalization one-year after intervention.Figure 1Figure 2

Early outcomes of the PASCAL P10 and the MitraClip XT transcatheter mitral leaflet approximation devices - A propensity score matched multicentre comparison

Abstract Background The edge-to-spacer PASCAL repair system was recently approved for percutaneous treatment of severe mitral regurgitation (MR). Comparative data with the MitraClip XT device which shows similar size and leaflet grasping features are lacking. Purpose Aim of this study was to compare the procedural and short-term safety and efficacy of two transcatheter mitral leaflet approximation devices, the PASCAL P10 and the MitraClip XT. Methods Overall, 566 patients underwent transcatheter mitral valve repair (TMVR) with PASCAL P10 (n=309) or MitraClip XT (n=257). The PASCAL P10 cohort included patients treated at 10 tertiary care centres in Germany between February and December 2019, while the MitraClip XT cohort consisted of patients treated at three of these 10 centres between May 2018 and September 2022. Propensity score (PS) matching based on the parameters gender, age, left ventricular ejection fraction, NYHA class, left ventricular end-diastolic diameter, left atrial volume index, vena contracta width, MR aetiology, and mean gradient resulted in 191 well balanced patient pairs. Primary efficacy endpoints were technical success, degree of residual MR at discharge and at 30-days as well as device success at 30-days. Primary safety endpoint was the rate of major adverse events (MAE) at 30-days. Results Technical success was 95.8% in the PASCAL group and 95.3% in the MitraClip group (P&amp;gt;0.99). An MR ≤2+ at discharge was numerically more frequent in the PASCAL than in the MitraClip group (PASCAL: 91.5% vs. MitraClip: 85.9%; P=0.101). An MR ≤1+ at discharge was achieved more frequently in the PASCAL group (PASCAL: 68.3% vs. MitraClip: 56.5%; P=0.025). This difference was sustained at 30-days with numerically more patients with residual MR ≤2+ (PASCAL: 89.7% vs. MitraClip: 82.4%; P=0.071) and significantly more patients with MR ≤1+ (PASCAL: 64.7% vs. MitraClip: 51.6%; P=0.021) in the PASCAL group than in the MitraClip group. At 30-days, the mean gradient was similar between the two groups (PASCAL: 3.0 [2.3–4.0] mmHg vs. MitraClip: 3.1 [2.7–4.2] mmHg], P=0.218). Device success at 30 days was achieved with an equal frequency in both groups (PASCAL: 78.8% vs MitraClip: 71.3%; P=0.129). At 30-days, MAE occurred more often in the MitraClip than in the PASCAL group (PASCAL: 3.7% vs. MitraClip: 12.6%; P=0.002). Conclusions In this PS-matched study comparing the PASCAL P10 with the MitraClip XT, safety and efficacy were comparable at 30-days.