Impact of Renal Congestion in Patients With Secondary Mitral Regurgitation After Mitral Transcatheter Edge-to-Edge Repair.

BACKGROUND: Renal congestion is a potential prognostic factor in patients with heart failure and recently, assessment has become possible with intrarenal Doppler ultrasonography (IRD). The association between renal congestion assessed by IRD and outcomes after mitral transcatheter edge-to-edge repair (TEER) is unknown, so we aimed to clarify renal congestion and its prognostic implications in patients with mitral regurgitation (MR) who underwent TEER using MitraClip system.Methods and Results: Patients with secondary MR who underwent TEER and were assessed for intrarenal venous flow (IRVF) by IRD were classified according to their IRVF pattern as continuous or discontinuous. Of the 105 patients included, 78 patients (74%) formed the continuous group and 27 (26%) were the discontinuous group. Kaplan-Meier analysis revealed significant prognostic power of the IRVF pattern for predicting the composite outcome of all-cause death and heart failure rehospitalization (log-rank P=0.0257). On multivariate Cox regression analysis, the composite endpoint was independently associated with the discontinuous IRVF pattern (hazard ratio, 3.240; 95% confidence interval, 1.300-8.076; P=0.012) adjusted using inverse probability of treatment weighting. CONCLUSIONS: IRVF patterns strongly correlated with clinical outcomes without changes in renal function. Thus, they may be useful for risk stratification after mitral TEER for patients with secondary MR.

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.

Effect of Diastolic Flow Reversal Patterns on Clinical Outcomes Following Transcatheter Aortic Valve Implantation　- An Intraprocedural Echocardiography Study.

BACKGROUND: Although diastolic flow reversal (DFR) in the descending aorta, assessed via transesophageal echocardiography (TEE), is a simple and easy indicator for evaluating aortic regurgitation, the association between DFR pattern and clinical outcomes following transcatheter aortic valve implantation (TAVI) is unclear. The purpose of this study was to evaluate the effect of DFR patterns on clinical outcomes following TAVI.Methods and Results:Two-hundred and eleven patients (mean age, 83.6±5.7 years; 69% female) who underwent TAVI were retrospectively assessed via intraprocedural TEE. DFR was evaluated using pulsed-wave Doppler in the descending aorta before and after TAVI. The primary endpoint was major adverse cardio-cerebrovascular events (MACCEs). Although only 7 patients (3.3%) had moderate or severe paravalvular leak, as assessed by color Doppler echocardiography, holo-DFR (HDFR) was observed in 33 patients (16.0%) after TAVI. MACCEs occurred in 40 patients during the median follow up of 282 days (interquartile range: 160-478 days). The estimated cumulative MACCE-free survival at 1 year was significantly lower in patients with HDFR than in those without HDFR. A Cox proportional hazards analysis revealed that HDFR after TAVI was independently associated with MACCEs. CONCLUSIONS: HDFR was associated with an increased risk of MACCEs after TAVI. DFR evaluated by intraprocedural echocardiography could serve as a simple and easy method for predicting clinical outcomes.

Usefulness of velocity ratio in patients with moderate aortic stenosis and reduced left ventricular ejection fraction.

Background. Moderate aortic stenosis (AS) increases left ventricular afterload and results in unfavorable outcomes in patients with reduced left ventricular ejection fraction (LVEF). Velocity ratio (VR) may be appropriate for the evaluation of aortic valve (AV) hemodynamics because of the low dependence on flow. Therefore, this study investigated the usefulness of VR on the clinical outcomes of such patients. Method. Clinical data of patients with moderate AS (AV area, 0.60-0.85 cm2/m2; peak AV velocity, 2.0-4.0 m/s) and reduced LVEF (LVEF 20-50%) were analyzed during 2010-2018. VR was calculated as peak left ventricular outflow tract velocity/peak AV velocity. The primary endpoint included all-cause death, heart failure hospitalization, and AV replacement. Results. In total, 104 patients (mean age, 75.9 ± 7.0 years; 62.5% men) were included. LVEF was 39.5% ± 7.8%. The AV area was 0.72 ± 0.08 cm2/m2, peak AV velocity was 2.59 ± 0.40 m/s, and VR was 0.30 ± 0.07. The follow-up period was 1.7 (0.5-3.5) years. Kaplan-Meier estimates for the endpoint were 59.9% at 3 years. Multivariable analysis revealed that VR (hazard ratio, 0.947; 95% confidence interval, 0.905-0.990; p = .018) was significantly related to this endpoint. Patients with a VR <0.25 had significantly higher incidence rates of the endpoint than those with a VR ≥0.25 (85.6% versus 47.8% at 3 years; p < .001). Conclusions. Patients with moderate AS and reduced LVEF have unfavorable clinical outcomes, particularly those with low VR.

Impact of perioperative change in physical function on midterm outcomes after transcatheter aortic valve implantation.

Preoperative frailty diminishes the potential for functional recovery after transcatheter aortic valve implantation (TAVI). However, perioperative changes in physical status and their impact on prognosis after TAVI have not previously been reported. Therefore, this study aimed to investigate whether perioperative changes in physical function affect prognosis in patients undergoing TAVI. We retrospectively reviewed 257 patients who underwent TAVI. The Short Physical Performance Battery (SPPB), an objective physical status assessment tool, was evaluated pre- and post-TAVI. Patients were divided into two groups: (i) patients whose SPPB score declined in the perioperative period (the decline group) and (ii) patients whose SPPB score did not decline in the perioperative period (the non-decline group). The primary endpoint was unplanned hospitalization owing to heart failure or cardiovascular death following TAVI. The mean follow-up period was 385 ± 151 days, mean age was 83.2 ± 5.8 years, and 67% of the patients were women. Sixteen patients required readmission owing to heart failure, and seven experienced cardiovascular-related death. Kaplan-Meier analysis revealed that the event-free rate was significantly lower in the decline group (log-rank, p = 0.006). A stepwise multivariate logistic regression analysis showed that a perioperative change in SPPB was significantly associated with primary endpoints (odds ratio, 1.51; 95% confidence interval, 1.12-2.04). Perioperative change in physical function was an independent risk factor for heart failure, hospitalization, or cardiovascular death following TAVI.

New-Generation Transcatheter Aortic Valves in Patients With Small Aortic Annuli　- Comparison of Balloon- and Self-Expandable Valves in Asian Patients.

BACKGROUND: Asian patients have smaller aortic annuli. Although 20-mm balloon-expandable (BE) transcatheter heart valves (THV) are manufactured for transcatheter aortic valve implantation (TAVI) in these cases, the supra-annular design of self-expandable (SE) THV is considered more suitable; however, real-world comparative data are scarce.Methods and Results:Consecutive TAVI cases (n=330) in a single Japanese center were reviewed. Based on the cutoff for the new-generation 20-/23-mm BE-THV, a small aortic annulus was defined as <330 mm2. A considerable number of patients had small annuli: 49/302 (16%). Of these, 33 BE-THV and 13 SE-THV using new-generation valves were compared. Although the SE-THV group had smaller annulus area (median 297 (interquartile range, 280-313) vs. 309 (303-323) mm2(P=0.022)), it had more favorable post-procedural parameters; for SE-THV and BE-THV, respectively, effective orifice area (EOA), 1.5 (1.3-1.6) vs. 1.1 cm2(0.9-1.3) (P=0.002); mean pressure gradient, 7.6 (5.6-11.0) vs. 14.2 mmHg (11.2-18.8) (P=0.001); and peak velocity, 1.8 (1.6-2.4) vs. 2.7 m/s (2.3-3.1) (P=0.001). Although new left bundle branch block was higher with SE-THV (24% and 62%, P=0.02), patient-prosthesis mismatch (PPM) ≥ moderate (indexed EOA <0.85 cm2/m2) was significantly less with SE-THV than with BE-THV (8% vs. 55%; P=0.04). Hemodynamic findings were consistent up to 1 year. CONCLUSIONS: Small annuli are often seen in Asian patients, for whom SE-THV implantation results in favorable hemodynamics with less PPM.

Effect of Immunosuppressive Therapy on Clinical Outcomes for Patients With Aortic Stenosis Following Transcatheter Aortic Valve Implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established treatment for symptomatic patients with severe aortic stenosis (AS). Sometimes patients with severe AS taking immunosuppressants are encountered. The effect of immunosuppressive therapy on clinical outcomes in patients with AS following TAVI were investigated.Methods and Results:In total, 282 consecutive patients with severe AS who underwent transfemoral TAVI from January 2016 to December 2018 at St. Marianna University School of Medicine were reviewed. They were divided into 2 groups: the immunosuppressants group (IM group) in which patients continually used immunosuppressive drugs (n=22) and the non-immunosuppressants group (non-IM group) (n=260). The composite endpoints of a major adverse cardiovascular and cerebrovascular event (MACCE) defined as non-lethal myocardial infarction, unstable angina pectoris, heart failure requiring hospitalization, stroke, and cardiovascular death were evaluated. There were no differences in the incidence of vascular access complications (32% vs. 20%, P=0.143) and the rate of procedure success (100% vs. 93%, P=0.377) between the IM and non-IM groups. During the median follow-up period of 567 (16-1,312) days after the TAVI procedure, there were no significant differences between the IM and non-IM groups in the incidence of infectious complications (14% vs. 9%, P=0.442) or MACCE (18% vs. 20%, respectively; P=0.845). CONCLUSIONS: The use of IM after TAVI is not associated with increased vascular access complications or mid-term MACCE in patients with severe AS treated with TAVI.

Clinical Impact of New-Onset Left Bundle-Branch Block After Transcatheter Aortic Valve Implantation in the Japanese Population　- A Single High-Volume Center Experience.

BACKGROUND: Although left bundle-branch block (LBBB) is a known conduction disorder that occurs after transcatheter aortic valve implantation (TAVI), its clinical impact in the Japanese population remains unclear.Methods and Results:Of the 298 consecutive patients who underwent TAVI from January 2016 to December 2018 in a high-volume center in Japan, 68 with prior or periprocedural permanent pacemaker implantation (PPI), pre-existing LBBB, death during hospitalization, aborted procedure, or incomplete data were excluded. Among the final cohort of 230 patients, new-onset LBBB occurred in 90 (39%) after TAVI and persisted at 1-month follow up in 29 patients (13%; persistent new-onset LBBB, PN-LBBB). On multivariable analysis, self-expandable valve (SEV) use was found to be the only predictor of PN-LBBB (odds ratio: 4.39, 95% confidence interval: 1.69-11.41, P=0.002). There were no differences between patients with and without PN-LBBB in terms of overall mortality (18.8% vs. 26.0%, log-rank P=0.90) or need for late PPI (4.0% vs. 3.5%, log-rank P=0.74), yet there was an increased re-admission rate for heart failure (HF) in the PN-LBBB group (15.6% vs. 8.0%, log-rank P=0.046) at a median follow up of 431 (interquartile range, 271-733) days. CONCLUSIONS: PN-LBBB following TAVI was not associated with mortality or late PPI, but with a higher incidence of HF-related re-hospitalization at the mid-term follow up.

Percutaneous transapical pseudoaneurysm closure following transcatheter aortic valve replacement.

Left ventricular pseudoaneurysm (LVP) formation is a rare but potentially life-threatening complication of transapical transcatheter aortic valve replacement (TAVR). Conventionally, a pseudoaneurysm has been treated surgically; however, improved transcatheter technique and device technology have made a percutaneous closure of LVP an increasingly viable option, especially in a patient unfavorable for surgery. A TAVR candidate is most likely at increased surgical-risk or inoperable. Therefore a percutaneous closure can be a reasonable strategy for LVP, but its experience following this emerging aortic valve procedure remains limited. We describe a case of LVP formation after TAVR in which it was efficiently treated with a percutaneous closure using a transapical approach via LVP. The first attempt was performed with a transfemoral approach. Pre-closure angiography revealed an eccentric shape of a LVP neck like a "chicken leg". This shape caused serious difficulty to cross LVP with a wire and it was not accomplished. However, the LVP location was at the apex and we could access from a chest wall through the pseudoaneurysm in the second attempt. This approach allowed a close and coaxial wire manipulation and the neck of LVP was finally crossed. After that, a closure device was deployed and the second procedure was successfully completed. An approach selection often contributes to a procedural success. This is the first case of a percutaneous LVP closure following TAVR using a transapical access and may suggest this approach as a possible option for this catheter closure in TAVR candidates. © 2016 Wiley Periodicals, Inc.

Safety and feasibility of zero-contrast transcatheter aortic valve implantation using balloon-expandable valves in patients with aortic stenosis and severe renal impairment: A single-center study.

BACKGROUND: Aortic stenosis (AS) and chronic kidney disease (CKD) can coexist. Repeat exposure to contrast media in patients undergoing transcatheter aortic valve implantation (TAVI) has latent mortality risks and increased risk for acute kidney injury. We aimed to assess our "zero-contrast TAVI" protocol for patients with advanced CKD. METHODS: Consecutive patients with severe AS who underwent TAVI at a single center registry were enrolled. Zero-contrast TAVI group included patients who underwent TAVI without contrast and who had an estimated glomerular filtration rate <30 mL/min/1.73 m2. Conventional TAVI group included patients who underwent the regular TAVI procedure. Patients using balloon-expandable valves via transfemoral approach were analyzed. Baseline clinical and procedural characteristics and clinical outcomes were compared between two groups. The primary outcome was early safety as defined by Valve Academic Research Consortium Criteria. Secondary outcomes included the presence of severe prosthesis-patient mismatch, moderate or greater perivalvular leakage, and requirement for new dialysis (within 3 months). RESULTS: A total of 520 patients were analyzed. Among these, 32 (6 %) underwent zero-contrast TAVI and 488 (94 %) conventional TAVI. In the zero-contrast TAVI group, 12 patients (37.5 %) had to use 20.7 (11.0-31.2) mL of contrast media. There were no significant differences in the primary and secondary outcomes between zero-contrast TAVI and conventional TAVI groups (78.1 % vs. 86.8 %, P = 0.184 and 9.4 % vs. 8.1 %, P = 0.738 for the primary and secondary outcomes, respectively). CONCLUSIONS: Zero-contrast TAVI is feasible, safe, and effective in patients with AS and stage 4 CKD.

Changes in exercise stress echocardiographic parameters before and after transcatheter mitral valve edge-to-edge repair.

The safety and feasibility are still not well known for exercise-induced mitral regurgitation (MR). This study is aimed to assess and compare the hemodynamic and symptomatic changes in patients with significant secondary MR during exercise stress echocardiography (ESE) before and after transcatheter edge-to-edge repair (TEER). The study included a total of 15 patients with secondary MR who underwent ESE before and after TEER using the MitraClip system (Abbott, Abbott Park, IL, USA). Echocardiographic data of ESE were collected both before the procedure and during the follow-up visit at 3 months. During the one-year postoperative observation period, the rate of readmission due to heart failure was 13% (n = 2), with no recorded fatalities. Although no significant differences of ESE data were observed in exercise-induced pulmonary hypertension or cardiac output before and after the repair, the severity of MR was significantly improved after the procedure, both at rest (2 [2-3] vs. 1 [1-2], p = 0.0125) and during ESE (3 [3-3] vs. 1 [1-1], p < 0.0001). Furthermore, the New York Heart Association Functional Classification was improved (3 [3-3] vs. 1 [1-1], p < 0.0001) after treatment. For a supplemental analysis, MR during ESE was significantly improved not only in cases with atrial secondary MR but also in ventricular secondary MR. Transcatheter edge-to-edge repair for exercise-induced MR resulted in a significant improvement in postoperative MR severity and subjective symptoms. These results are novel, as they have not been extensively reported previously, particularly among Japanese patients.

Leaflet length and left main coronary artery occlusion following transcatheter aortic valve replacement.

Coronary artery occlusion during transcatheter aortic valve replacement is a rare complication. However, it is a very severe and life-threatening event. Although there are some possible causes of this phenomenon, definite etiologies and predictors are unknown because of the small number. We describe one case of left main coronary artery occlusion immediately after deployment of a prosthetic valve. The patient became hypotensive and developed cardiopulmonary arrest. However, the coronary artery was successfully stented with a help of cardiopulmonary bypass and he recovered well. In this case, pre-procedural computed tomography (CT) showed the adequately high coronary height and no other significant conventional predictor for coronary occlusion. The examinations were retrospectively reviewed and the CT showed a long leaflet compared to the coronary sinus complex. The fluoroscopy appeared to show the long leaflet covering the left main coronary artery ostium immediately after the valve deployment. The height of the coronary artery ostium from the aortic annulus appeared sufficiently high in this case and did not explain the coronary compromise; leaflet length in relation to the coronary sinus dimension seemed more relevant. The ratio between leaflet length and curved coronary sinus height (L/C) may be one novel predictor for coronary artery occlusion.

Two-year Outcomes of Ventricular-demand Leadless Pacemaker Therapy for Heart Block After Transcatheter Aortic Valve Replacement.

Ventricular-demand leadless pacemakers (VVI-LPMs) have often been used as an alternative to atrioventricular (AV) synchronous transvenous pacemakers (DDD-TPMs) in patients with high-grade AV block following transcatheter aortic valve replacement (TAVR). However, the clinical outcomes of this unusual usage are not elucidated. Patients who received permanent pacemakers (PPMs) owing to new-onset high-grade AV block after TAVR from September 2017 to August 2020 at a high-volume center in Japan were included in the analysis, and the clinical courses of VVI-LPM and DDD-TPM implants through 2 years of follow-up were compared retrospectively. Out of 413 consecutive patients who underwent TAVR, 51 (12%) patients received a PPM. After excluding 8 patients with chronic atrial fibrillation (AF), 3 with sick sinus syndrome, and 1 with incomplete data, 17 VVI-LPMs and 22 DDD-TPMs were included in our final cohort. The VVI-LPM group had lower serum albumin levels (3.2 ± 0.5 vs. 3.9 ± 0.4 g/dL, P < .01) than the DDD-TPM group. Follow-up revealed no significant differences between the 2 groups in terms of the incidence of late device-related adverse events (0% vs. 5%, log-rank P = .38) and new-onset AF (6% vs. 9%, log-rank P = .75); however, there were increases in the rates of all-cause death (41% vs. 5%, log-rank P < .01) and heart failure rehospitalization (24% vs. 0%, log-rank P = .01) in the VVI-LPM group. This small retrospective study reveals favorable post-procedural complication rates but higher all-cause mortality with VVI-LPM compared to DDD-TPM therapy for high-grade AV block after TAVR at 2 years of follow-up.

Feasibility of Transcatheter Aortic Valve Implantation in Patients With Very Severe Aortic Stenosis.

Background: Very severe aortic stenosis (AS) has a poor prognosis even in asymptomatic patients, and asymptomatic very severe AS is a Class IIa indication for aortic valve replacement, although the safety and effectiveness of transcatheter aortic valve implantation (TAVI) for very severe AS is not well-established. Methods and Results: This study included 366 patients undergoing TAVI at a single center, with 85 and 281 patients in the very severe AS (peak velocity ≥5 m/s or mean pressure gradient (PG) ≥60 mmHg) and severe AS groups, respectively. Procedural and clinical outcomes at 1-year follow-up were compared between groups. The calcium scores were significantly higher in the very severe AS group (2,864.5 vs. 1,405.8 arbitrary units [AU] (P<0.001). Although the patient-prosthesis mismatch rate was higher in the very severe AS group (38.3% vs. 25.7%; P=0.029), there was no significant difference in the early safety and clinical efficacy between the groups (16.5% vs. 17.1% and 12.0% vs. 18.9%, respectively). Similarly, there was no significant difference in all-cause mortality at 1 year (4.8% vs. 9.8%). Conclusions: Despite a higher incidence of prosthesis-patient mismatch in those with very severe AS, the procedural and clinical outcomes were comparable to those in patients with severe AS. TAVI may be a reasonable treatment option for very severe AS.

Prognostic impact of transcatheter mitral valve repair in patients with exercise-induced secondary mitral regurgitation.

AIMS: Although exercise-induced secondary mitral regurgitation (MR) is known to have a poor prognosis, the therapeutic strategy towards this condition remains to be investigated. In the present study, we aimed to investigate the prognostic impact of transcatheter mitral valve repair (TMVr) using the MitraClip in patients with exercise-induced secondary MR. METHODS AND RESULTS: Of the 200 consecutive patients with secondary MR who underwent exercise stress echocardiography, 46 (23%) that presented with exercise-induced secondary MR [i.e. increase in effective regurgitant orifice area (EROA) of ≥ 0.13 cm2] were enrolled in the present investigation. The composite endpoints of all-cause mortality and hospitalization for heart failure were evaluated. Of the 46 patients included in the current cohort, 19 (41%) underwent TMVr and 27 (59%) were medically managed (control group). Although the TMVr group tended to present with a greater EROA at rest (0.26 ± 0.10 vs. 0.20 ± 0.08 cm2, P = 0.047), there were no differences in the EROA changes during exercise between the two groups (0.18 ± 0.10 vs. 0.18 ± 0.04 cm2, P = 0.940). While the TMVr group reported a higher event-free survival rate after the 13-month follow-up period (log-rank P = 0.017), the Cox proportional-hazard analysis suggested the TMVr to be associated with clinical outcomes (hazard ratio: 0.419, P = 0.044). CONCLUSION: As opposed to the medical management, TMVr treatment was associated with a lower risk of composite endpoints in patients with exercise-induced secondary MR. Exercise stress echocardiography is considered to have played an important role in decision-making for secondary MR.

Impact of Prosthesis-Patient Mismatch on Hemodynamics During Exercise in Patients With Aortic Stenosis After Transcatheter Aortic Valve Implantation With a Balloon-Expandable Valve.

BACKGROUND: There is no evidence of hemodynamic performance during exercise in patients with aortic stenosis (AS) after transcatheter aortic valve implantation (TAVI). This study aimed to investigate the changes in kinematic hemodynamics during exercise and determine the impact of prosthesis-patient mismatch (PPM) on the hemodynamics of transcatheter heart valves using exercise stress echocardiography (ESE) in AS patients after TAVI. METHODS AND RESULTS: This study enrolled 77 consecutive patients (mean age 82 ± 5 years, 50.6% male) who underwent ESE 3-6 months after TAVI with a balloon-expandable valve. The effective orifice area index at rest was significantly correlated with the mean pressure gradient (PG) during exercise (p <0.001). The patients were divided into two groups according to the presence of PPM (PPM and non-PPM groups). During exercise, the patients with PPM had a higher left ventricular ejection fraction (74.6 ± 6.1% vs. 69.7 ± 9.6%, p = 0.048), a lower stroke volume index (47.2 ± 14.0 ml/m2 vs. 55.6 ± 14.5 ml/m2, p = 0.037), a significantly higher mean transvalvular PG (21.9 ± 9.1 mmHg vs. 12.2 ± 4.9 mmHg, p = 0.01) and an increased mean PG from rest to exercise (5.7 ± 3.5 mmHg vs. 2.3 ± 2.8 mmHg, p <0.001) compared with patients without PPM. Patients with PPM had a higher pulmonary artery systolic pressure (SPAP) during exercise (57.3 ± 13.8 mmHg vs. 49.7 ± 10.9 mmHg, p = 0.021) and a higher incidence of exercise-induced pulmonary hypertension (43.8 vs. 15.0%, p = 0.037) than patients without PPM. PPM was strongly associated with exercise-induced pulmonary hypertension (hazard ratio: 3.570, p = 0.013). CONCLUSIONS: AS patients with PPM after TAVI showed a disproportionate increase in the transvalvular PG and SPAP during exercise, and PPM was associated with exercise-induced pulmonary hypertension.

Angioscopic Evaluation of Atrial Septal Defect Closure Device Neo-Endothelialization.

Background Current guidelines recommend at least 6 months of antithrombotic therapy and antibiotic prophylaxis after septal-occluding device deployment in transcatheter closure of atrial septal defect. It has been estimated that it takes ≈6 months for complete neo-endothelialization; however, neo-endothelialization has not previously been assessed in vivo in humans. Methods and Results The neointimal coverage of septal occluder devices was evaluated 6 months after implantation in 15 patients by angioscopy from the right atrium. Each occluder surface was divided into 9 areas; the levels of endothelialization in each area were semiquantitatively assessed by 4-point grades. Device neo-endothelialization was sufficient in two thirds of patients, but insufficient in one third. In the comparison between patients with sufficiently endothelialized devices of average grade score ≥2 (good endothelialization group, n=10) and those with poorly endothelialized devices of average grade score <2 (poor endothelialization group, n=5), those in the poor endothelialization group had larger devices deployed (27.0 mm [25.0-31.5 mm] versus 17.0 mm [15.6-22.5 mm], respectively) and progressive right heart dilatation. The endothelialization was poorer around the central areas. Moreover, the prevalence of thrombus formation on the devices was higher in the poorly endothelialized areas than in the sufficiently endothelialized areas (Grade 0, 94.1%; Grade 1, 63.2%; Grade 2, 0%; Grade 3, 1.6%). Conclusions Neo-endothelialization on the closure devices varied 6 months after implantation. Notably, poor endothelialization and thrombus attachment were observed around the central areas and on the larger devices.

Influence of coronary artery disease and percutaneous coronary intervention on mid-term outcomes in patients with aortic valve stenosis treated with transcatheter aortic valve implantation.

BACKGROUND: A high frequency of coronary artery disease (CAD) is reported in patients with severe aortic valve stenosis (AS) who undergo transcatheter aortic valve implantation (TAVI). However, the optimal management of CAD in these patients remains unknown. HYPOTHESIS: We hypothesis that AS patients with TAVI complicated by CAD have poor prognosis. His study evaluates the prognoses of patients with CAD and severe AS after TAVI. METHODS: We divided 186 patients with severe AS undergoing TAVI into three groups: those with CAD involving the left main coronary (LM) or proximal left anterior descending artery (LAD) lesion (the CAD[LADp] group), those with CAD not involving the LM or a LAD proximal lesion (the CAD[non-LADp] group), and those without CAD (Non-CAD group). Clinical outcomes were compared among the three groups. RESULTS: The CAD[LADp] group showed a higher incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) and all-cause mortality than the other two groups (log-rank p = .001 and p = .008, respectively). Even after adjustment for STS score and percutaneous coronary intervention (PCI) before TAVI, CAD[LADp] remained associated with MACCE and all-cause mortality. However, PCI for an LM or LAD proximal lesion pre-TAVI did not reduce the risk of these outcomes. CONCLUSIONS: CAD with an LM or LAD proximal lesion is a strong independent predictor of mid-term MACCEs and all-cause mortality in patients with severe AS treated with TAVI. PCI before TAVI did not influence the outcomes.

Comparison in Clinical Outcomes Between Leadless and Conventional Transvenous Pacemaker Following Transcatheter Aortic Valve Implantation.

OBJECTIVES: Atrioventricular block is a common complication of transcatheter aortic valve implantation (TAVI). Although conventional transvenous dual-chamber (DDD) pacemaker (PM) is ideal for atrioventricular block, leadless PM, which is less invasive, may be suitable for frail TAVI patients. Little is known about clinical outcomes of this newer device following TAVI. METHODS: A total of 330 consecutive patients undergoing TAVI were reviewed. Of these, PM cases without atrial fibrillation were studied. Indication for leadless PM was based on heart team discussion. RESULTS: PM implantations were performed in 30 patients (9.1%), and 24 patients (7.3%) had no atrial fibrillation. These 24 patients had 14 DDD-PMs and 10 leadless PMs, and formed the two study groups. Baseline characteristics were similar except for ejection fraction: median ages were 83.0 years (IQR, 81.0-87.0 years) vs 86.5 years (IQR, 83.5-90.3) (P=.18); 11 (78.6%) vs 8 (80%) were women (P=.67); Society of Thoracic Surgeons scores were 5.1% (IQR, 3.8%-5.9%) vs 5.3% (IQR, 3.4%-8.5%) (P=.82); and ejection fractions were 68.0% (IQR, 66.0%-70.5%) vs 59.0% (IQR, 52.8%-69.3%) (P=.049), for the DDD-PM and leadless PM groups, respectively. There was 1 case of atrial lead dislodgment in the DDD-PM group; otherwise, no complications related to the implantation procedure were found. The leadless PM group showed numerically shorter hospital stay: 12.5 days (range, 9.0-17.8 day) in the DDD-PM group vs 10.5 days (range, 7.8-15.3 days) in the leadless PM group (P=.44). Six-month follow-up revealed no significant differences in incidence of heart failure rehospitalizations or deaths: 2 (14.3%) in the DDD-PM group vs 2 (25%) in the leadless PM group (P=.47); and 2 (14.3%) in the DDD-PM group vs 0 (0%) in the leadless PM group (P=.39), respectively. CONCLUSIONS: Patients with leadless PM following TAVI may have shorter hospital stays, and clinical outcomes can be comparable with DDD-PMs. Leadless PMs may therefore be a reasonable option for frail TAVI patients.