Geographic variability and operator trends of transcatheter edge-to-edge repair in the United States.

BACKGROUNDS: Transcatheter edge-to-edge repair (TEER) devices are used for primary mitral regurgitation (MR) and secondary MR. Despite the growing use of TEER devices, there have not been many studies on operator experience or procedure volumes by state. AIMS: We aimed to investigate nationwide operator volume trends and geographic variation in access to TEER. METHODS: The United States Center for Medicare and Medicaid Services (CMS) National Medicare Provider Utilization and Payment Database (MPUPD) was analyzed between 2015 and 2020 for initial TEER procedures. RESULTS: Procedure volume and total operators increased yearly from 2015 to 2019 but declined in 2020. Mean annual procedure volume per operator varied significantly by state, between 0 in multiple states and 35 in North Dakota. In 2019, 994 unique operators were identified, with 295 operators documented performing 10 or more procedures (29.68%). Operators performing 10 or more TEER procedures provided 68.46% of all operations in 2019, averaging 20.94 procedures per operator. CONCLUSIONS: TEER procedures are becoming increasingly common as more operators are being trained. However, significant variability exists in the procedural volume per operator.

Understanding transcatheter edge-to-edge repair "knobology": Advanced catheter steering for different scenarios of transseptal puncture.

Following the introduction in the latest European and American guidelines, transcatheter edge-to-edge repair has become a valid alternative to surgery for ineligible patients. Among the available technologies, MitraClip (Abbott) was the first to be introduced for the percutaneous treatment of mitral regurgitation with the edge-to-edge technique. Although its safety and effectiveness has been widely demonstrated, the optimal procedural results are highly dependent from operators' experience. In this manuscript, we provide a full guide of advanced steering maneuvers of MitraClip in different scenarios of transseptal puncture.

Prognostic impact of vasopressor test in transcatheter edge-to-edge repair of secondary mitral regurgitation: The PETIT study.

BACKGROUND: Vasopressor test (VPT) might be useful in patients with functional mitral regurgitation (MR) and left ventricular dysfunction (MITRA-FR-like patients) during transcatheter edge-to-edge repair (TEER). AIMS: We aimed to evaluate the prognostic impact of VPT. METHODS: MR treated with TEER were included in a multicenter prospective registry. VPT was used intraprocedurally in patients with left ventricular dysfunction and/or hypotension. The 1-year echocardiographic and clinical outcomes were compared according to the use of VPT. The primary endpoint was a combination of mortality + heart failure (HF) readmission at 1-year. RESULTS: A total of 1115 patients were included, mean age was 72.8 ± 10.5 years and 30.4% were women. VPT was performed in 128 subjects (11.5%), more often in critically ill patients with biventricular dysfunction. Postprocedurally the VPT group had greater rate of MR ≥ 2+ (46.9% vs. 31.7%, p = 0.003) despite greater number of devices (≥2 clips, 52% vs. 40.6 p = 0.008) and device repositioning or new clip in 12.5%. At 1-year, the primary endpoint occurred more often in the VPT group (27.3% vs. 16.9%, p = 0.002) as well as all-cause mortality (21.9% vs. 8.1%, p ≤ 0.001) but no differences existed in HF readmission rate (14.8% vs. 13.2%, p = 0.610), cardiovascular mortality (4.4% vs. 3.9%, p = 0.713) or residual MR ≥ 2+ (51.1% vs 51.7%, p = 0.371). CONCLUSIONS: Dynamic evaluation of MR during TEER procedure through VPT was performed in patients with worse baseline risk who also presented higher all-cause mortality at 1-year follow-up. However, 1-year residual MR, cardiovascular mortality and HF readmission rate remained comparable suggesting that VPT might help in the management of MITRA-FR-like patients.

A modified Carpentier classification in transcatheter edge-to-edge repair for mitral regurgitation.

Mitral regurgitation (MR) is the most common heart valve disease, and transcatheter edge-to-edge repair (TEER) has been recommended as a therapy for severe MR patients by guidelines. The classic Carpentier classification used to guide surgical mitral valve repair but is inadequate for mitral TEER (M-TEER). We herein proposed a new modified Carpentier classification named after "type + segment," which is suitable for M-TEER. We shared our strategies in M-TEER procedure for screening and performing the M-TEER according to the new modified Carpentier classification.

Impact of systolic dominant pulmonary venous flow morphology on outcomes after mitral transcatheter edge-to-edge repair.

BACKGROUND: The prognostic significance of intraprocedural pulsed-wave Doppler analysis of pulmonary venous flow (PVF) during mitral transcatheter edge-to-edge repair (TEER) remains understudied. We aimed to investigate the prognostic value of systolic dominant-PVF (SD-PVF) morphology post-TEER. METHODS: In a retrospective analysis from December 2019 to December 2022, patients undergoing mitral TEER were categorized into SD-PVF and systolic blunting (SB)-PVF groups based on post-TEER morphology. The primary endpoint was a composite of all-cause mortality or heart failure hospitalization at 1 year. We investigated the association of PVF morphology post-TEER with the primary endpoint at 1 year using Cox regression and compared the prognostic accuracy of PVF variables through receiver operating characteristic (ROC) curve analysis. RESULTS: Among 187 patients (mean age 76.4 ± 10.5 years, 51.3% primary etiology), residual mitral regurgitation (MR) ≤mild was observed in 147 (82.4%) patients and 105 (56.2%) had SD-PVF post-TEER. Patients with SD-PVF had a lower incidence of >2+ residual MR after clip deployment, at 30 days (2.1% vs. 13.1%; p = 0.005) and at 1 year (1.4% vs. 9%; p = 0.08). SD-PVF post-TEER was independently associated with the primary endpoint (HR = 0.59, 95% CI = 0.39-0.87; p = 0.009). ROC curve analysis of the prognostic accuracy of SD-PVF demonstrated an AUC of 0.64 (95% CI = 0.54-0.73), comparable to other quantitative measures of PVF. CONCLUSION: Assessing PVF morphology after clip deployment offers a simple prognostic tool for patients undergoing mitral TEER. Multicenter cohorts will be necessary to further investigate its prognostic value.

Contemporary experience of mitral transcatheter edge-to-edge repair technology in patients with mitral annular calcification.

BACKGROUND: Mitral annular calcification (MAC) has been an exclusion for many of the earlier pivotal trials that were instrumental in gaining device approval and indications for mitral transcatheter edge-to-edge repair (M-TEER). AIMS: To evaluate the impact of MAC on the procedural durability and success of newer generation MitraClip® systems (G3 and G4 systems). METHODS: Data were collected from Northwell TEER registry. Patients that underwent M-TEER with third or fourth generation MitraClip device were included. Patients were divided into -MAC (none-mild) and +MAC (moderate-severe) groups. Procedural success was defined as ≤ grade 2 + mitral regurgitation (MR) postprocedure, and durability was defined as ≤ grade 2 + MR retention at 1 month and 1 year. Univariate analysis compared outcomes between groups. RESULTS: Of 260 M-TEER patients, 160 were -MAC and 100 were +MAC. Procedural success was comparable; however, there were three patients who required conversion to cardiac surgery during the index hospitalization in the +MAC group versus none in the -MAC group (though this was not statistically significant). At 1-month follow-up, there were no significant differences in MR severity. At 1-year follow-up, +MAC had higher moderate-severe MR (22.1% vs. 7.5%; p = 0.002) and higher mean transmitral gradients (5.3 vs. 4.0 mmHg; p = 0.001) with no differences in mortality, New York Heart Association functional class or ejection fraction. CONCLUSION: In selective patients with high burden of MAC, contemporary M-TEER is safe, and procedural success is similar to patients with none-mild MAC. However, a loss of procedural durability was seen in +MAC group at 1-year follow-up. Further studies with longer follow-ups are required to assess newer mTEER devices and their potential clinical implications in patients with a high burden of MAC.

Iatrogenic atrial septal defects in structural heart interventions: Opening the Pandora's box.

In the modern era of structural heart interventions, the total number of transseptal procedures is growing exponentially, thus increasing the rate and need for management of iatrogenic atrial septal defects (iASDs). To date, there are no official guidelines on the assessment and management of iASDs, due to inconclusive evidence on whether patients benefit more from the percutaneous closure of iASD than from conservative management and vigorous follow-up. Despite the abundance of observational studies on iASDs, there is still a lack of randomized studies. Evidence so far show that percutaneous closure is no superior over conservative treatment in patients with iASDs, however, it has been demonstrated that patients with spontaneous closure of iASDs experience less heart failure (HF) hospitalizations. On the other hand, researchers have investigated the beneficial nature of interatrial shunt therapy in patients with HFpEF and, more recently, with HFrEF, due to the presumed hemodynamic benefits. Herein, we provide an updated review of relevant literature, focusing on iASD persistence rates, predicting factors for their persistence, and clinical outcomes of iASD persistence, to summarize available evidence and discuss future directions in the field.

Impact of the MitraClip G4 System on Routine Practice and Outcomes in Patients With Secondary Mitral Regurgitation.

BACKGROUND: The MitraClip G4 system is a new iteration of the transcatheter edge-to-edge repair system. We assessed the impact of the G4 system on routine practice and outcomes in secondary mitral regurgitation (2°MR).Methods and Results: Consecutive patients with 2°MR treated with either the MitraClip G2 (n=89) or G4 (n=63) system between 2018 and 2021 were included. Baseline characteristics, procedures, and outcomes were compared. Inverse probability of treatment weighting and Cox regression were used to adjust for baseline differences. Baseline characteristics were similar, except for a lower surgical risk in the G4 group (Society of Thoracic Surgeons Predicted Risk of Mortality ≥8: 38.1% vs. 56.2%; P=0.03). In the G4 group, more patients had short (≤2 mm) coaptation length (83.7% vs. 54.0%; P<0.001) and fewer clips were used (17.5% vs. 36.0%; P=0.02). Acceptable MR reduction was observed in nearly all patients, with no difference between the G4 and G2 groups (100% vs. 97.8%, respectively; P=0.51). The G4 group had fewer patients with high transmitral gradients (>5mmHg; 3.3% vs. 13.6%; P=0.03). At 1 year, there was no significant difference between groups in the composite endpoint (death or heart failure rehospitalization) after baseline adjustment (10.5% vs. 20.2%; hazard ratio 0.39; 95% confidence interval 0.11-1.32; P=0.13). CONCLUSIONS: The G4 system achieved comparable device outcomes to the early-generation G2, despite treating more challenging 2°MR with fewer clips.

Efficacy of Native T1 Mapping for Patients With Non-Ischemic Cardiomyopathy and Ventricular Functional Mitral Regurgitation Undergoing Transcatheter Edge-to-Edge Repair.

BACKGROUND: We investigated the efficacy of left ventricular (LV) myocardial damage by native T1mapping obtained with cardiac magnetic resonance (CMR) for patients undergoing transcatheter edge-to-edge repair (TEER). METHODS AND RESULTS: We studied 40 symptomatic non-ischemic heart failure (HF) patients and ventricular functional mitral regurgitation (VFMR) undergoing TEER. LV myocardial damage was defined as the native T1Z-score, which was converted from native T1values obtained with CMR. The primary endpoint was defined as HF rehospitalization or cardiovascular death over 12 months after TEER. Multivariable Cox proportional hazards analysis showed that the native T1Z-score was the only independent parameter associated with cardiovascular events (hazard ratio 3.40; 95% confidential interval 1.51-7.67), and that patients with native T1Z-scores <2.41 experienced significantly fewer cardiovascular events than those with native T1Z-scores ≥2.41 (P=0.001). Moreover, the combination of a native T1Z-score <2.41 and more severe VFMR (effective regurgitant orifice area [EROA] ≥0.30 cm2) was associated with fewer cardiovascular events than a native T1Z-score ≥2.41 and less severe VFMR (EROA <0.30 cm2; P=0.002). CONCLUSIONS: Assessment of baseline LV myocardial damage based on native T1Z-scores obtained with CMR without gadolinium-based contrast media is a valuable additional parameter for better management of HF patients and VFMR following TEER.

The safety of transesophageal echocardiography to guide transcatheter tricuspid valve edge-to-edge repair.

BACKGROUND: Transesophageal echocardiography (TEE) is primarily used to guide transcatheter structural heart interventions, such as tricuspid transcatheter edge-to-edge repair (TEER). Although TEE has a good safety profile, it is still an invasive imaging technique that may be associated with complications, especially when performed during long transcatheter procedures or on frail patients. The aim of this study was to assess TEE-related complications during tricuspid TEER. METHODS: This is a prospective study enrolling 53 patients who underwent tricuspid TEER for severe tricuspid regurgitation (TR). TEE-related complications were assessed clinically and divided into major (life-threatening, major bleeding requiring transfusions or surgery, organ perforation, and persistent dysphagia) and minor (perioral hypesthesia, < 24 h dysphagia/odynophagia, minor intraoral bleeding and hematemesis not requiring transfusion) RESULTS: The median age of the patient population was 79 years; 43.4% had severe, 39.6% massive, and 17.6% torrential TR. 62.3% of patients suffered from upper gastrointestinal disorders. Acute procedural success (APS) was achieved in 88.7% in a median device time of 36 min. A negative association was shown between APS and lead-induced etiology (r = -.284, p = .040), baseline TR grade (r = -.410, p = .002), suboptimal TEE view (r = -.349, p = .012), device time (r = -.234, p = .043), and leaflet detachment (r = -.496, p < .0001). We did not observe any clinical manifest major or minor TEE-related complications during the hospitalization. CONCLUSIONS: Our study reinforces the good safety profile and efficacy of TEE guidance during tricuspid TEER. Adequate preoperative management and intraprocedural precautions are mandatory in order to avoid serious complications. Furthermore, suboptimal intraprocedural TEE views are associated with lower TR reduction rates. HIGHLIGHTS: Transesophageal echocardiography is a crucial and safe technique for guiding transcatheter structural heart interventions. A mix of mid/deep esophageal and trans gastric views, as well as real-time 3D imaging is generally used to guide the procedure. Adequate preoperative management and intraprocedural precautions are mandatory in order to avoid serious problems. A shorter device time is associated with more rarely probe-related complications. Suboptimal intraprocedural TEE views are associated with lower TR reduction rates.