Transcatheter Edge-to-Edge Mitral Valve Repair versus Minimally Invasive Mitral Valve Surgery: An Observational Study.

Background: Minimally invasive mitral valve surgery (MIC-MVS) has been established as preferred treatment of mitral regurgitation (MR), but mitral transcatheter edge-to-edge valve repair (M-TEER) is routinely performed in patients at high surgical risk and is increasingly performed in intermediate risk patients. Methods: From 2010 to 2021, we performed 723 M-TEER and 123 isolated MIC-MVS procedures. We applied a sensitivity analysis by matching age, left ventricular ejection fraction (LVEF), EuroSCORE II and etiology of MR. Results: Baseline characteristics showed significant differences in the overall cohort (p < 0.01): age 78.3 years vs. 61.5 years, EuroSCORE II 5.5% vs. 1.3% and LVEF 48.4% vs. 60.4% in M-TEER vs. MIC-MVS patients. Grade of MR at discharge was moderate/severe in 24.5% (171/697) in M-TEER vs. 6.5% (8/123) in MIC-MVS (p < 0.01). One-year survival was 91.5% (552/723) in M-TEER vs. 97.6% (95/123) in MIC-MVS (p = 0.04). A matching with 49 pairs (n = 98) showed comparable survival during follow-up, but a numerically higher mean mitral valve gradient of 4.1 mmHg (95% CI: 3.6-4.6) vs. 3.4 mmHg (95% CI: 3.0-3.8) in M-TEER (p = 0.04). Conclusions: Patients undergoing M-TEER had lower one-year survival than MIC-MVS, but differences disappeared after matching. Reduction in MR was less effective in M-TEER patients and postprocedural mitral valve gradients were higher.

Cardiac computed tomography-based assessment of mitral annular calcification in patients undergoing mitral transcatheter edge-to-edge repair.

BACKGROUND: The role of assessment of mitral annular calcification (MAC) using cardiac computed tomography (CCT) in mitral transcatheter edge-to-edge repair (TEER) remains unclear. The aim of this study was to investigate the association of MAC assessed by CCT with procedural and clinical outcomes in patients undergoing TEER. METHODS: We retrospectively analyzed 275 patients who underwent pre-procedural CCT prior TEER. Mitral calcium volume (MCV) and MAC score were measured by CCT. Functional procedural success was defined as residual mitral regurgitation of ≤2+ with mean transmitral gradient of <5 â€‹mmHg at discharge. All-cause mortality within two years after TEER was collected. RESULTS: MAC was present in 115 of 275 patients (41.8 %). The median MCV was 198 â€‹mm3 (interquartile range [IQR]: 84 to 863 â€‹mm3), and the median MAC score was 3 (IQR: 2 to 4). Higher MCV and MAC score were inversely related to the rate of functional procedural success, independently of anatomical features of mitral valve. Patients with moderate/severe MAC, defined as MAC score of ≥4, had a lower rate of functional procedural success than those without MAC (56.1 â€‹% vs. 81.3 â€‹%; p â€‹= â€‹0.002). Moreover, higher MCV and MAC score were associated with a higher risk of all-cause mortality within two years, irrespective of baseline characteristics and functional procedural success. CONCLUSIONS: The presence and burden of MAC assessed by CCT were associated with procedural and clinical outcomes in patients undergoing TEER. The CCT-based assessment of MAC may improve patient selection for TEER.

The CT derived angle between the transseptal puncture site and the left atrial appendage as a predictor for complex interventional occlusion procedures.

OBJECTIVE: To evaluate the role of the CT-derived angle between the intra-atrial septum (IAS) and the left atrial appendage (LAA) on procedural complexity and clinical outcomes in left atrial appendage occlusion (LAAO) procedures. BACKGROUND: Given the broad variations in anatomy, LAAO remains one of the most challenging interventional procedures in structural heart disease. In recent years, preprocedural cardiac tomography (CT) has evolved as a valuable tool; however, prediction of procedural complexity remains cumbersome. METHODS: We retrospectively analyzed 47 patients that underwent LAAO at our center in whom pre-procedural cardiac CT-scans were available. Among other baseline parameters, we measured the angle between the LAA ostium and the preferred transseptal puncture site at the IAS. We compared patients with an angle above and below the median regarding procedural characteristics and procedural outcome. RESULTS: The median angle between the LAA and the IAS was 127.3° (IQR: 120.9-141.3). LAAO took longer in patients with a measured angle below the median (55.0 ± 22.7 min vs. 41.3 ± 17.5 min; p = .04), resulting in longer radiation times (13.0 ± 5.3 min vs. 9.8 ± 5.7 min; p = .04) and more contrast use (61.1 ± 47.5 mL vs. 33.6 ± 24.7 mL; p = .05). Moreover, the necessity for a sheath exchange was significantly higher (30.4% vs. 4.2%, p = .02) and device repositioning or device resizing trended to be more frequent (26.1% vs. 8.3%; p = .1 and 21.7% vs. 8.3%; p = .2). There were no differences in procedural outcome, device-position and peri-device leak (PDL). CONCLUSIONS: The angle between the transseptal puncture site and the LAA ostium may serve as a predictor for more demanding LAAO interventions. In our study a steeper angle led to a prolonged procedure resulting in higher doses of contrast and radiation, but was not associated with a worse procedural outcome.

Left ventricular reverse remodeling after transcatheter aortic valve implantation in patients with low-flow low-gradient aortic stenosis.

OBJECTIVES: Left ventricular reverse remodeling (LVRR) is associated with improved outcome in patients with heart failure. Factors associated with and predictive of LVRR in patients with low-flow low-gradient aortic stenosis (LFLG AS) after transcatheter aortic valve implantation (TAVI) and its impact on outcome were assessed. METHODS: Pre- and postprocedural left ventricular (LV) function and volume were investigated in 219 patients with LFLG. LVRR was defined as an absolute increase of ≥10% in LV ejection fraction (LVEF) and reduction of ≥15% in LV end-systolic volume (LVESV). The primary endpoint was the combination of all-cause mortality and rehospitalization for heart failure. RESULTS: The mean LVEF was 35.0 ± 10.0%, with a stroke volume index (SVI) of 25.9 ± 6.0 mL/m2 and LVESV of 94.04 ± 46.0 mL. At a median of 5.2 months (interquartile range, 2.7-8.1 months), 77.2% (n = 169) of the patients showed echocardiographic evidence of LVRR. A multivariate model revealed three independent factors for LVRR after TAVI: SVI of <25 mL/m2 (hazard ratio [HR], 2.31; 95% confidence interval [CI], 1.08-3.58; p < 0.01), LVEF of <30% (HR, 2.76; 95% CI, 1.53-2.91; p < 0.01), and valvulo-arterial impedance (Zva) of <5 mmHg/mL/m2 (HR, 5.36; 95% CI, 1.80-15.98; p < 0.01). Patients without evidence of LVRR showed a significantly higher incidence of the 1-year combined endpoint (32 [64.0%] vs. 75 [44.4%], p < 0.01). CONCLUSIONS: The majority of patients with LFLG AS show LVRR after TAVI, which is associated with favorable outcomes. An SVI of <25 mL/m2, LVEF of <30%, and Zva < 5mmHg/mL/m2 represent predictors of LVRR.

Impact of New eGFR Equations on Risk Assessment In Patients Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: Recently, the Chronic Kidney Disease-Epidemiology Collaboration working group has published new formulas for race-independent estimation of glomerular filtration rate (GFR). We investigated the old and new eGFR equations in patients transcatheter aortic valve implantation (TAVI). METHODS: We conducted a retrospective analysis based on the data from a prospective registry of patients who underwent TAVI from January 2008 to May 2019. The primary endpoint was 30-day mortality after TAVI, and the secondary endpoints included one- and three-year mortality. RESULTS: In total, 1792 patients undergoing TAVI were included in the present analysis. The thirty-day mortality was 4.6 % (95 % CI 3.8-5.7 %), and the one- and three-year mortality were 17.5 % (95 % CI 15.7-19.4 %) and 34.4 % (95 % CI 32.0-37.0 %). After the application of the new eGFR formula, 12.0 % of patients were reclassified within the GFR category in CKD, while 13.2 % of patients were reclassified within the GFR categories of the EuroSCORE II. Hazard ratios for 30-day, one-year, and three-year mortality increased after introduction of the new creatine-based eq. (1.51, 1.52, 1.49 vs. 1.87, 1.79, 1.74, respectively). Compared to the old equation, the new eGFR <60 ml/min/1.73 m2 had a better discrimination ability for the 30-day mortality (Harell's C: 0.563 (95 % CI 0.518-0.608) vs, 0.583 (95 % CI 0.546-0.636); delta Harell's C, 0.031 ± 0.022, p < 0.001). Similar findings were consistently observed in the cystatin creatinine-based equations. CONCLUSIONS: The application of the new race-independent estimators of GFR results in the reassessment of renal function in a significant proportion of TAVI patients and may influence the risk stratification of this population.

Deep sedation vs. general anesthesia for transcatheter tricuspid valve repair.

Background: Transcatheter tricuspid valve repair (TTVr) is routinely performed under general anesthesia (GA). This study aimed to investigate whether TTVr procedures can be performed effectively and safely without GA but using deep sedation (DS). Methods: We performed a retrospective analysis of 104 patients from three centers who underwent TTVr between 2020 and 2021. The primary performance endpoints were technical success and severity of TR assessed at the time of discharge. The safety outcome was a composite of in-hospital complications, including occurrence of death, conversion to surgery, major adverse cardiac and cerebrovascular events, major vascular complications, or occurrence of pneumonia. Results: Sixty-four procedures were performed in GA and 40 procedures were performed in DS. The groups did not differ in age, EuroScore II, TR severity, ventricular function, or hemodynamic parameters. Technical success was achieved in 92.5% of the patients in the DS group and in 93.6% of the patients in the GA group (p = 0.805). In none of the patients intraprocedural conversion from DS to GA was required. There was no difference in total duration of the procedure, and number of devices implanted. The degree of TR was ≤2+ in 77.5% of the patients in the DS group and in 74.2% of the patients in the GA group (p = 0.705). The composite safety endpoint did not differ between the groups (2.5 vs. 6.3%, p = 0.384). The total duration of hospital stay was shorter in patients who underwent TTVr in DS compared to those who underwent TTVr in GA (6 [5, 9] days vs. 8 [6, 11] days; p = 0.011). Conclusion: Performing TTVr in DS was effective with similar procedural results, and was safe with similar low complication rates compared to GA.

Acute Kidney Injury Following Tricuspid Transcatheter Edge-to-Edge Repair.

BACKGROUND: Little is known about the incidence and clinical relevance of postprocedural acute kidney injury (AKI) in patients undergoing transcatheter edge-to-edge repair (TEER) for tricuspid regurgitation (TR). OBJECTIVES: The aim of this study was to investigate the prognostic impact of postprocedural AKI following TEER for TR. METHODS: Two hundred sixty-eight patients who underwent TEER for TR at 2 centers were retrospectively analyzed. Postprocedural AKI was defined as an increase in serum creatinine of ≥0.3 mg/dL within 48 hours or ≥50% within 7 days after the procedure compared with baseline. The association between AKI and the composite outcome, consisting of all-cause mortality and rehospitalization for heart failure within 1 year after the procedure, was determined. RESULTS: The mean age of the patients was 79.0 ± 6.8 years, and 43.3% were men. Postprocedural AKI occurred in 42 patients (15.7%). Age, male sex, an estimated glomerular filtration rate of <60 mL/min/1.73 m2, and absence of procedural success were associated with the occurrence of AKI. Patients with AKI had a higher incidence of in-hospital mortality than those without AKI (9.5% vs 0.9%; P = 0.006). Moreover, AKI was associated with the incidence of the composite outcome within 1 year after TEER for TR (adjusted HR: 2.39; 95% CI: 1.45-3.94; P = 0.001). CONCLUSIONS: Postprocedural AKI occurred in 15.7% of patients undergoing TEER for TR, despite the absence of iodinated contrast agents, which was associated with worse clinical outcomes. These findings highlight the clinical impact of AKI following TEER for TR and should help in identifying patients at high risk for AKI.

Percutaneous trans-axilla transcatheter aortic valve replacement.

The left axillary artery is an attractive alternative access route for transcatheter aortic valve replacement (TAVR) and may provide better outcomes compared to other alternatives. Nevertheless, there remain concerns about vascular complications, lack of compressibility, and thorax-related complications. Between March 2019 and March 2021, 13 patients underwent transaxillary TAVR for severe aortic stenosis at the University Hospital Bonn. The puncture was performed with a puncture at the distal segment of the axillary artery through the axilla, with additional femoral access for applying a safety wire inside the axillary artery. Device success was defined according to the VARC 2 criteria. The study participants were advanced in age (77 ± 9 years old), and 54% were female, with an intermediate risk for surgery (STS risk score 4.7 ± 2.0%). The average diameter of the distal segment of the axillary artery was 5.8 ± 1.0 mm (i.e., the puncture site) and 7.6 ± 0.9 mm for the proximal axillary artery. Device success was achieved in all patients. 30-day major adverse cardiac and cerebrovascular events were 0%. With complete percutaneous management, stent-graft implantation was performed at the puncture site in 38.5% of patients. Minor bleeding was successfully managed with manual compression. Moreover, no thorax-related complications, hematomas, or nerve injuries were observed. Percutaneous trans-axilla TAVR was found to be feasible and safe. This modified approach may mitigate the risk of bleeding and serious complications in the thorax and be less invasive than surgical alternatives.

Oncologic outcomes in elderly patients who underwent hysterectomy for endometrial cancer: a multi-institutional survey in Kinki District, Japan.

BACKGROUND: The goal of this study is to assess the oncologic outcomes of elderly patients who underwent hysterectomy for endometrial cancer across three variables: hysterectomy approach, lymph node resection, and adjuvant therapy. METHODS: Hospital records of patients aged ≥ 70 years who underwent hysterectomy for endometrial cancer were obtained from 19 institutions. Patients were categorized into three risk groups: low, intermediate, and high. In each group, disease-free survival and overall survival were compared according to hysterectomy approach, lymph node resection, and adjuvant therapy using Kaplan-Meier method. Cox regression analysis with a 95% confidence interval was performed to estimate relative risk (RR) of death. RESULTS: A total of 1246 patients were included. In the low-risk group, the adjusted RR for death for minimally invasive surgery (MIS) versus laparotomy and lymph node resection versus no lymph node resection were 0.64 (0.24-1.72) and 0.52 (0.24-1.12), respectively. In the intermediate-risk group, the adjusted RR for death for MIS versus laparotomy, lymph node resection versus no lymph node resection, and adjuvant therapy versus no adjuvant therapy were 0.80 (0.36-1.77), 0.60 (0.37-0.98), and 0.89 (0.55-1.46), respectively. In the high-risk group, the adjusted RRs for death for lymph node resection versus no lymph node resection and adjuvant therapy versus no adjuvant therapy were 0.56 (0.37-0.86) and 0.60 (0.38-0.96), respectively. CONCLUSIONS: MIS is not inferior to laparotomy in uterine-confined diseases. Lymph node resection improved the outcome for all disease stages and histological types. In contrast, adjuvant therapy improved the outcomes only in high-risk patients.

Clinical outcomes of transcatheter aortic valve implantation in patients younger than 70 years rejected for surgery: the AMTRAC registry.

BACKGROUND: The mean age of transcatheter aortic valve implantation (TAVI) patients is steadily decreasing. AIMS: The aim of the study was to describe the characteristics, the indications for and the outcomes of TAVI in patients <70 years old. METHODS: All patients undergoing TAVI (n=8,626) from the 18 participating centres between January 2007 and June 2020 were stratified by age (70). For patients <70, the indications for TAVI were extracted from Heart Team discussions and the baseline characteristics and mortality were compared between the two groups. RESULTS: Overall, 640 (7.4%) patients were <70 (9.1% during 2018-2020, p<0.001); the mean age was 65.0±2.3 years. The younger patients were more often male, with bicuspid valves or needing valve-in-valve procedures. They had a higher prevalence of lung disease and diabetes. In 80.7% of cases, the Heart Team estimated an increased surgical risk and TAVI was selected, reflected by an STS score >4% in 20.4%. Five-year mortality was similar (29.4 vs 29.8%, HR 0.95, p=0.432) in the <70 and >70 groups. In the <70 group, mortality was higher for those referred for TAVI due to an increased surgical risk compared to those referred for other reasons (31.6 vs 24.5%, HR 1.23, p=0.021). Mortality was similar regardless of the STS stratum in patients judged by the Heart Team to be at increased surgical risk (32.6 vs 30.4%, HR 0.98, p=0.715). CONCLUSIONS: Use of TAVI in patients <70 is becoming more frequent. The main reason for choosing TAVI is due to an increased surgical risk not adequately represented by the STS score. The outcomes for these patients are similar to those for older TAVI patients. Dedicated trials of TAVI/SAVR in younger patients are needed to guide decisions concerning expansion of TAVI indications. ((ClinicalTrials.gov: NCT04031274).

Transcatheter aortic valve implantation in patients with a small aortic annulus: performance of supra-, intra- and infra-annular transcatheter heart valves.

BACKGROUND: A small aortic annulus is associated with increased risk of prosthesis-patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI). Whether specific transcatheter heart valve (THV) designs yield superior hemodynamic performance in these small anatomies remains unclear. METHODS: Data from 8411 consecutive patients treated with TAVI from May 2012 to April 2019 at four German centers were retrospectively evaluated. A small aortic annulus was defined as multidetector computed tomography-derived annulus area < 400 mm2. TAVI was performed with a balloon-expanding intra-annular (Sapien-3, n = 288), self-expanding intra-annular (Portico, n = 110), self-expanding supra-annular (Evolut, n = 179 and Acurate-Neo, n = 428) and mechanically expanding infra-annular (Lotus, n = 64) THV according to local practice. PPM was defined as indexed effective orifice area ≤ 0.85cm2/m2. RESULTS: A small annulus was found in 1069 (12.7%) patients. PPM was detected in 38.3% overall with a higher prevalence after implantation of a balloon-expanding intra-annular or mechanically expanding infra-annular THV compared to self-expanding intra- and supra-annular THV. Multivariable analysis linked self-expanding THV (Evolut: Odds ratio [OR] 0.341, Acurate-Neo: OR 0.436, Portico: OR 0.291), postdilatation (OR 0.648) and age (OR 0.968) to lower rates of PPM, while aortic valve calcification was associated with an increased risk (OR 1.001). Paravalvular regurgitation > mild was more frequent after TAVI with self-expanding THV (p = 0.04). CONCLUSION: In this large contemporary multicenter patient population, a substantial number of patients with a small aortic anatomy were left with PPM after TAVI. Self-expanding supra- and intra-annular THV demonstrated superior hemodynamics in these patients at risk, however at the cost of higher rates of residual paravalvular regurgitation.

Frailty in patients undergoing transcatheter aortic valve replacement: prognostic value of the Geriatric Nutritional Risk Index.

BACKGROUND: Malnutrition is a hallmark of frailty, is common among elderly patients, and is a predictor of poor outcomes in patients with severe symptomatic aortic stenosis (AS). The Geriatric Nutritional Risk Index (GNRI) is a simple and well-established screening tool to predict the risk of morbidity and mortality in elderly patients. In this study, we evaluated whether GNRI may be used in the risk stratification and management of patients undergoing transcatheter aortic valve replacement (TAVR). METHODS: Patients with symptomatic severe AS (n = 953) who underwent transfemoral TAVR at the University Hospital Schleswig-Holstein Kiel, Germany, between 2010 and 2019 (development cohort) were divided into two groups: normal GNRI ≥ 98 (no nutrition-related risk; n = 618) versus low GNRI < 98 (at nutrition-related risk; n = 335). The results were validated in an independent (validation) cohort from another high-volume TAVR centre (n = 977). RESULTS: The low-GNRI group had a higher proportion of female patients (59.1% vs. 52.1%), higher median age (82.9 vs. 81.8 years), prevalence of atrial fibrillation (50.4% vs. 40.0%), median logistic EuroSCORE (17.5% vs. 15.0%) and impaired left ventricular function (<35%: 10.7% vs. 6.8%), lower median estimated glomerular filtration rate (50 vs. 57 mL/min/1.73 m2 ) and median albumin level (3.5 vs. 4.0 g/dL) compared with the normal-GNRI group. Among peri-procedural complications, Acute Kidney Injury Network (AKIN) Stage 3 was more common in the low-GNRI group (3.6% vs. 0.6%, p = 0.002). After a mean follow-up of 21.1 months, all-cause mortality was significantly increased in the low-GNRI group compared with the normal-GNRI group (p < 0.001). This was confirmed in the validation cohort (p < 0.001). Low GNRI < 98 was identified as an independent risk factor for all-cause mortality (hazard ratio 1.44, 95% CI 1.01-2.04, p = 0.043). Other independent risk factors included albumin level < median of 4.0 g/dL, high-sensitive troponin T in the highest quartile (> 45.0 pg/mL), N-terminal pro-B-type natriuretic peptide in the highest quartile (> 3595 pg/mL), grade III-IV tricuspid regurgitation, pulmonary arterial hypertension, life-threatening bleeding, AKIN Stage 3 and disabling stroke. CONCLUSIONS: Low GNRI score was associated with an increased risk of all-cause mortality in patients undergoing TAVR, implying that this vulnerable group may benefit from improved preventive measures.

Grade 1 Endometrioid Carcinoma With an Area of Serous Carcinoma Less than 5% Is More Aggressive than Stage IA Pure-type Grade 1 Endometrioid Carcinoma.

BACKGROUND/AIM: In 2020, the percentages were removed from the World Health Organization's criteria for mixed carcinoma. The aim was to examine the clinical significance of an area of serous carcinoma (SC) <5%. PATIENTS AND METHODS: Our study included 236 patients with the 2009 International Federation of Obstetrics and Gynecology (FIGO) stage IA grade 1 endometrioid carcinoma (EG1) from multiple hospitals. EG1 patients with an area of SC <5% and those with pure-type EG1 were retrospectively compared. RESULTS: In the multivariate analysis for recurrence, an area of SC <5% was an independent risk factor [hazard ratio (HR)=101.51, p<0.01]. In the multivariate analysis for progression-free survival, an area of SC <5% was identified as a negative prognostic factor (HR=62.43, p<0.01). CONCLUSION: EG1 with an area of SC <5% may be more aggressive than pure-type EG1 at FIGO stage IA.

Risk of mortality following transcatheter aortic valve replacement for low-flow low-gradient aortic stenosis.

BACKGROUND: Low-flow low-gradient (LF-LG) aortic stenosis (AS) is associated with high mortality, even after transcatheter aortic valve replacement (TAVR). Further knowledge of risk indicators is needed and a clinical risk score would be desirable for optimizing patient selection and therapeutic strategy. METHODS: The study cohort comprised of 219 consecutive LF-LG AS patients undergoing TAVR from 2008 to 2018 in two high-volume German centers. Predictive factors for one-year all-cause mortality were defined according to a Cox proportional hazard model. RESULTS: At one-year follow-up after TAVR, 28% of patients had died. A multivariate model revealed six independent predictors of one-year mortality: history of myocardial infarction (HR 2.05, 95%CI 1.13-3.72), eGFR < 30 ml/min/1.73m2 (HR 2.75, 95%CI 1.48-5.11), tricuspid regurgitation moderate or more (HR 2.06, 95%CI 1.14-3.72), stroke volume index < 25 mL/m2 (HR 2.03, 95%CI 1.14-3.62), self-expandable device (HR 2.72, 95%CI 1.17-6.27), and non-transfemoral approach (HR 3.42, 95%CI 1.28-9.14). The Rhineland Risk Score (RRS) consisting of these variables (c statistic 0.75, 95%CI 0.68-0.82, p < 0.001) was superior to the EuroSCORE II (c statistic 0.63) and STS-PROM score (c statistic 0.69) at predicting one-year mortality. Patients with a RRS ≥ 8 had a prohibitive risk of one-year mortality of 67.6% (95%CI 52.0-82.4%). CONCLUSION: In patients with LF-LG AS, history of myocardial infarction, renal dysfunction, tricuspid regurgitation, a low stroke volume index, self-expandable device, and non-femoral approach were associated with increased 1-year mortality after TAVR. The RRS might serve as a helpful tool for risk prediction and patient selection for TAVR in patients with LF-LG AS.

PASCAL versus MitraClip-XTR edge-to-edge device for the treatment of tricuspid regurgitation: a propensity-matched analysis.

BACKGROUND: Transcatheter tricuspid valve repair (TTVR) is a promising technique for the treatment of tricuspid regurgitation (TR). Data comparing the performance of novel edge-to-edge devices (PASCAL and MitraClip-XTR) are scarce. METHODS: We identified 80 consecutive patients who underwent TTVR using either the PASCAL or MitraClip-XTR system to treat symptomatic TR from July 2018 to June 2020. To adjust for baseline imbalances, we performed a propensity score (PS) 1:1 matching. The primary endpoint was a reduction in TR severity by at least one grade at 30 days. RESULTS: The PS-matched cohort (n = 44) was at high-surgical risk (EuroSCORE II: 7.5% [interquartile range (IQR) 4.8-12.1%]) with a mean TR grade of 4.3 ± 0.8 and median coaptation gap of 6.2 mm [IQR 3.2-9.1 mm]. The primary endpoint was similarly observed in both groups (PASCAL: 91% vs. MitraClip-XTR: 96%). Multiple device implantation was the most common form (59% vs. 82%, p = 0.19), and the occurrence of SLDA was comparable between the PASCAL and MitraClip-XTR system (5.7% [2 of 35 implanted devices] vs. 4.4% [2 of 45 implanted devices], p = 0.99). No periprocedural death or conversions to surgery occurred, and 30-day mortality (5.0% vs. 5.0%, log-rank p = 0.99) and 3-month mortality (10.0% vs. 5.0%, log-rank p = 0.56) were similar between both groups. During follow-up, functional NYHA class, 6-min walking distance, and health status improved in both groups. CONCLUSIONS: Both TTVR devices, PASCAL and MitraClip-XTR, appeared feasible and comparable for an effective TR reduction. Randomized head-to-head comparisons will help to further define the appropriate scope of application of each system.

Impact of cancer history on clinical outcome in patients undergoing transcatheter edge-to-edge mitral repair.

BACKGROUND: Little is known about the prevalence of a history of cancer and its impact on clinical outcome in mitral regurgitation (MR) patients undergoing transcatheter mitral valve repair (TMVR). OBJECTIVES: The purpose of this study is to investigate the prevalence of cancer, baseline inflammatory parameters, and clinical outcome in MR patients undergoing TMVR. METHODS: Consecutive patients undergoing a MitraClip procedure were enrolled, and the patients were stratified into two groups: cancer and non-cancer. Baseline complete blood counts (CBC) with differential hemograms were collected prior to the procedure to calculate the platelet-to-lymphocyte ratio (PLR) and neutrophil-to-lymphocyte ratio (NLR). All-cause death within a one-year was examined. RESULTS: In total, 82 out of 446 patients (18.4%) had a history of cancer. Cancer patients had a significantly higher baseline PLR [181.4 (121.1-263.9) vs. 155.4 (109.4-210.4); P = 0.012] and NLR [5.4 (3.5-8.3) vs. 4.0 (2.9-6.1); P = 0.002] than non-cancer patients. A Kaplan-Meier analysis revealed that cancer patients had a significantly worse prognosis than non-cancer (estimated 1-year mortality, 20.2 vs. 9.2%; log-rank P = 0.009), and multivariable analyses of three models showed that cancer history was an independent factor for 1-year mortality. Patients who died during follow-up had a significantly higher baseline PLR [214.2 (124.2-296.7) vs. 156.3 (110.2-212.1); P = 0.007] and NLR [6.4 (4.2-12.5) vs. 4.0 (2.9-6.2); P < 0.001] than survivors. CONCLUSIONS: In MitraClip patients, a history of cancer was associated with higher inflammatory parameters and worse prognosis compared to non-cancer patients. Central Illustration. Clinical outcomes and baseline PLR and NLR values accord-ing to one-year mortality. (Left) Patients who died within the follow-up period had a significantly higher baseline PLR (214.2 [124.2-296.7] vs 156.3 [110.2-212.1]; P = 0.007) and NLR (6.4 [4.2-12.5] vs 4.0 [2.9-6.2]; P < 0.001) than patients who survived. PLR, platelet-to-lymphocyte ratio; NLR, neutrophil-to-lymphocyte ratio (Right) A Kaplan-Meier analysis revealed that cancer patients had a significantly worse prognosis than non-cancer patients (estimated one-year mortality, 20.2 vs 9.2%; log-rank P = 0.009).

Impact of Coronary Artery Disease on Outcomes in Patients Undergoing Percutaneous Edge-to-Edge Repair.

OBJECTIVES: The aim of this observational study was to evaluate the impact of concomitant coronary artery disease (CAD) on outcomes in patients undergoing percutaneous valve repair with the MitraClip system. BACKGROUND: Mitral valve regurgitation and CAD are often coexistent in elderly patients undergoing percutaneous mitral valve repair. The impact of CAD and revascularization on outcomes in this patient cohort, however, remains uncertain. METHODS: In 444 MitraClip patients, CAD severity was assessed, represented by the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS), as well as the residual SS (rSS) and SYNTAX score II (SS-II). Patients were stratified according to CAD severity and SS-II values (SS ≤3 vs. SS >3 and SS-II ≤45 vs. SS-II >45) and according to remaining CAD burden into 2 groups (rSS = 0 vs. rSS >0) to compare 1-year all-cause mortality. RESULTS: Higher SS, rSS, and SS-II were associated with mortality (22% for SS >3 vs. 9.6% for SS ≤3 [p < 0.001], 31.4% for rSS >0 vs. 9.6% for rSS = 0 [p < 0.001], and 17.1% for SS-II > 45 vs. 11.2% for SS-II ≤45 [p = 0.044]). The rSS was an independent predictor of 1-year all-cause mortality (p = 0.001) in multivariate analysis. CONCLUSIONS: The complexity of CAD, as assessed using the SS, is associated with outcomes in patients undergoing MitraClip procedures. The burden of residual CAD after percutaneous coronary intervention is an independent predictor of 1-year all-cause mortality. Patients undergoing complete revascularization had the most favorable outcomes independent of mitral regurgitation etiology.

Prognostic Impact of Redo Transcatheter Mitral Valve Repair for Recurrent Mitral Regurgitation.

There is little known about the prognostic impact of a redo transcatheter mitral valve repair (TMVR) for residual or recurrent mitral regurgitation (MR). From January 2011 to March 2019, we identified 43 consecutive patients who underwent a redo TMVR procedure with the MitraClip system. A control cohort was treated medically for MR ≥2+ after the first TMVR and was propensity score 1:1 matched using age, gender, MR severity, trans-mitral pressure gradient, and etiology of MR. To investigate the association of redo TMVR with 1-year mortality, we fitted a Cox proportional hazard model. The technical success rate of redo TMVR was 95%. A reduction in MR to ≤2+ was achieved in 79% of patients, with a significant decline of tricuspid regurgitation pressure gradient and improvement of the New York Heart Association class. After matching was performed, 43 well-matched pairs of patients were analyzed. Redo TMVR patients showed lower 1-year mortality (10.5% vs 37.6%, p = 0.01) compared with the control patients. Redo TMVR was associated with better survival (hazard ratio [HR] 0.26, 95% confidence interval [CI] 0.08 to 0.79, p = 0.02) and lower risk of the composite end point (mortality and rehospitalization due to HF: HR 0.34, 95% CI 0.15 to 0.78; p = 0.01) at 1-year follow-up. The association with the primary end point remained significant after accounting for the New York Heart Association class III/IV, TR ≥severe, the type of MR (i.e., recurrent or residual MR), or the type of previous implanted TMVR device. In conclusion, redo TMVR in selected patients with residual or recurrent MR may be associated with lower 1-year mortality than medical therapy alone.

Pulmonary capillary wedge pressure (PCWP) as prognostic indicator in patients undergoing transcatheter valve repair (TTVR) of severe tricuspid regurgitation.

BACKGROUND: TTVR represents a minimal invasive alternative for patients with tricuspid regurgitation (TR). PCWP is a haemodynamic parameter indicating pulmonary hypertension due to left-sided heart failure. METHODS: We evaluated pulmonary capillary wedge pressure (PCWP) as prognostic outcome parameter in patients undergoing transcatheter tricuspid valve repair (TTVR). A total of 60 patients who underwent right heart catheterization prior to TTVR were included. Patient population was categorized into a low and high PCWP group according to the median PCWP of 16 mmHg. RESULTS: TTVR included transcatheter tricuspid annuloplasty (13 patients) and edge-to-edge repair [37 patients for isolated TR; 10 patients for combined TR and mitral regurgitation]. Kaplan-Meier analysis and log-rank test revealed reduced 6-months event-free survival for patients with high PCWP (>16 mmHg) in comparison to those with low PCWP (≤16 mmHg) (p = 0.009). High PCWP was associated with increased occurrence of the composite endpoint of death and cardiac readmission (HR 4.67, 1.32-16.55). Moreover, adjusted with other predictive variables within the univariate analysis (left ventricular ejection fraction, history of smoking, tricuspid annular plane systolic excursion), PCWP remained an endpoint predictor (HR 1.11, 1.003-1.24). Best predicting value was evaluated for the cut-off >16 mmHg (AUC 0.700, 0.552-0.848). Patients with a high PCWP tended to have less TR recurrence (p = 0,059) and lower NYHA class (p = 0.062) after one month of follow-up. CONCLUSION: Here we demonstrate that PCWP is a predictive outcome parameter in TTVR patients. Patients with a PCWP ≤16 mmHg had a favourable outcome with lower mortality and morbidity gaining more benefit of TTVR.