Background: Transcatheter mitral valve repair with the MitraClip system has been established in selected high-risk patients. The MitraClip procedure results in a relatively large iatrogenic atrial ...septal defect (iASD). This study aimed to investigate the prevalence and clinical course of iASD requiring transcatheter closure following the MitraClip procedure.Methods and Results: This study was conducted at all 59 institutions that perform transcatheter mitral valve repair with the MitraClip system in Japan. The data of patients on whom transcatheter iASD closure was performed were collected. Of the 2,722 patients who underwent the MitraClip procedure, 30 (1%) required transcatheter iASD closure. The maximum iASD size was 9±4 mm (range, 3–18 mm). The common clinical course of transcatheter iASD closure was hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt. Of the 30 patients, 22 (73%) required transcatheter closure within 24 h following the MitraClip procedure, including 12 with hypoxemia and 5 with right-sided heart failure complicated with cardiogenic shock. Of the 5 patients, 2 required mechanical circulatory support devices. Twenty-one patients immediately underwent transcatheter iASD closure, and hemodynamic deteriorations were resolved; however, 1 patient died without having undergone transcatheter closure.Conclusions: Transcatheter iASD closure was required in 1% of patients who underwent the MitraClip procedure. Many of these patients immediately underwent transcatheter iASD closure because of hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt.
Background: Side branch (SB) occlusion during bifurcation stenting is a serious complication. This study aimed to predict SB compromise (SBC) using optical coherence tomography (OCT).Methods and ...Results: Among the 168 patients who enrolled in the 3D-OCT Bifurcation Registry, 111 bifurcation lesions were analyzed to develop an OCT risk score for predicting SBC. SBC was defined as worsening of angiographic SB ostial stenosis (≥90%) immediately after stenting. On the basis of OCT before stenting, geometric parameters (SB diameter SBd, length from proximal branching point to carina tip BP-CT length, and distance of the polygon of confluence dPOC) and 3-dimensional bifurcation types (parallel or perpendicular) were evaluated. SBC occurred in 36 (32%) lesions. The parallel-type bifurcation was significantly more frequent in lesions with SBC. The receiver operating characteristic curve indicated SBd ≤1.77 mm (area under the curve AUC=0.73, sensitivity 64%, specificity 75%), BP-CT length ≤1.8 mm (AUC=0.83, sensitivity 86%, specificity 68%), and dPOC ≤3.96 mm (AUC=0.68, sensitivity 63%, specificity 69%) as the best cut-off values for predicting SBC. To create the OCT risk score, we assigned 1 point to each of these factors. As the score increased, the frequency of SBC increased significantly (Score 0, 0%; Score 1, 8.7%; Score 2, 28%; Score 3, 58%; Score 4, 85%; P<0.0001).Conclusions: Prediction of SBC using OCT is feasible with high probability.
BACKGROUNDThere are limited data on the prognostic impact of periprocedural pulmonary hypertension (PH) after transcatheter aortic valve replacement (TAVR). OBJECTIVESThe aim of this study was to ...investigate the prognostic impact of normalized, new-onset, and residual PH after TAVR. METHODSThe OCEAN-TAVI (Optimized Transcatheter Valvular Intervention-Transcatheter Aortic Valve Implantation) registry is an ongoing, multicenter Japanese registry that includes 2,588 patients who underwent TAVR. Patients were classified into 4 groups according to periprocedural systolic pulmonary artery pressure by echocardiography: no PH before and after TAVR (no PH), PH before but not after TAVR (normalized PH), PH after but not before TAVR (new-onset PH), and PH before and after TAVR (residual PH). A systolic pulmonary artery pressure cutoff of >36 mm Hg was applied for PH. The primary endpoint was all-cause mortality at 2 years. Logistic regression analysis was used to identify clinical predictors of residual and new-onset PH. RESULTSIn total, 1,872 patients were divided into 4 groups: 1,027 (54.9%) in the no PH group, 257 (13.7%) in the normalized PH group, 280 (15.0%) in the new-onset PH group, and 308 (16.5%) in the residual PH group. There was a significant difference in all-cause mortality among the 4 groups at 2 years (11.0%, 12.8%, 18.6%, and 24.7%, respectively; P < 0.01). Among 565 patients who had preprocedural PH, 257 (45.5%) experienced normalization of PH, with mortality comparable with that in the no PH group. In multivariable logistic regression analysis, predictors of residual PH after TAVR were atrial fibrillation and baseline tricuspid regurgitation moderate or greater, whereas prosthesis-patient mismatch was a predictor of new-onset PH. CONCLUSIONSRisk stratification on the basis of post-TAVR PH status can identify patients at increased mortality after TAVR. Prosthesis-patient mismatch was identified as a novel predictor of new-onset PH. (Optimized Transcatheter Valvular Intervention-Transcatheter Aortic Valve Implantation OCEAN-TAVI; UMIN000020423).
The MitraClip system is used for patients with severe mitral regurgitation (MR) who are at high risk for open surgery. However, some patients need surgical revision for various complications. The ...acute outcome of MitraClip treatment for atrial functional MR (aFMR) is scarcely reported. Herein, we describe a rare case of an 80-year-old woman treated with a MitraClip for aFMR with mitral annular dilatation and failed leaflet adaptation. The patient suffered from single leaflet device attachment (SLDA) and posterior leaflet injury 3 days posttreatment. The patient successfully underwent mitral valve replacement. The postoperative pulmonary hypertension was markedly improved and the left atrial volume was reduced. A MitraClip should be carefully used for aFMR with mitral annular dilatation and failed leaflet adaptation as it may cause SLDA.
•The STS score was designed to predict 30-day mortality after cardiac surgery.•Lower mortality after transcatheter aortic valve implantation than was predicted.•High STS score is associated with an ...increased risk of long-term mortality.•Similar long-term mortality in patients with low and intermediate scores.
The Society of Thoracic Surgeons (STS) risk model, designed to predict operative mortality after cardiac surgery, is often used for the risk assessment of patients considered for transcatheter aortic valve implantation (TAVI). We investigated the long-term prognostic value of the STS score by utilizing the data of 2588 patients undergoing TAVI from the OCEAN (Optimized CathEter vAlvular iNtervention)—TAVI Japanese multicenter registry. The patients were divided into 3 groups according to their pre-procedural STS score as follows: low-risk (STS score <4%, n = 467 18%), intermediate-risk (4%≤ STS score <8%, n = 1200 46.4%), and high-risk (8%≤ STS score, n = 921 35.6%). Low-risk patients were younger and were more frequently male. The prevalence of most of the comorbidities were higher in high-risk patients, while active cancer was more frequent in low-risk patients (p <0.001).The cumulative 4-year all-cause mortality rates were higher in high-risk patients (49.0%) but comparable in low-risk (22.6%) and intermediate-risk patients (28.7%) (hazard ratio HR for intermediate-risk versus low-risk, 1.03; 95% confidence interval CI, 0.77 to 1.37; p = 0.85; HR for high-risk versus low-risk, 2.27; 95% CI 1.72 to 2.99; p = <0.001). Similarly, the cumulative 4-year cardiovascular mortality rates were higher in high-risk patients (20.5%) but comparable in low-risk (9.9%) and intermediate-risk patients (10.3%) (HR for intermediate-risk versus low-risk, 1.10; 95% CI, 0.68 to 1.77; p = 0.69; HR for high-risk versus low-risk, 2.33; 95% CI 1.48 to 3.67; p = <0.001). After adjustment for several confounders, STS score ≥8% was independently associated with increased long-term mortality (HR, 1.35; 95% CI, 1.08 to 1.68). In conclusion, the risk stratification according to STS score demonstrated an increased risk of long-term mortality after TAVI in high-risk patients, albeit with comparable risks in intermediate- and low-risk patients.
High-degree atrioventricular block (HAVB) or complete heart block (CHB) is a common complication associated with transcatheter aortic valve replacement (TAVR). However, some patients with HAVB/CHB ...recover with time. The results of electrophysiological studies (EPSs) using permanent pacemaker implantation (PPI) in patients with suspicious HAVB/CHB are considered controversial.This study aimed to evaluate whether HAVB/CHB induction at the bedside using a temporary pacemaker can predict recurrence in patients who had recovered from HAVB/CHB after TAVR.We enrolled a total of 11 patients who had recovered from HAVB/CHB and evaluated their electrophysiology using right ventricular pacing and/or procainamide administration.HAVB/CHB induction was positive. Three patients tested positive for HAVB/CHB, whereas 8 tested negative. The ejection fraction and the interval between HAVB/CHB onset and EPS were found to be significant. HAVB/CHB positive patients underwent PPI. A patient with a balloon-expandable valve tested positive just before recovery of CHB, but tested negative 5 days later and was included in the negative group. The 4 patients who tested negative received a cardiovascular implantable electric device (CIED). We observed HAVB/CHB in 2 patients who had previously tested positive after 3 months. Among those who tested negative, those with CIED had no HAVB/CHB, and others showed neither HAVB/CHB on electrocardiogram nor experienced syncope or sudden death.Our EPS revealed that HAVB/CHB induction may predict HAVB/CHB recurrence after TAVR. Valve type and EPS timing may affect the results.
The Wound, Ischemia, foot Infection (WIfI) classification system is used to predict the amputation risk in patients with critical limb ischemia (CLI). The validity of the WIfI classification system ...for hemodialysis (HD) patients with CLI is still unknown. This single-center study evaluated the prognostic value of WIfI stages in HD patients with CLI who had been treated with endovascular therapy (EVT).
A retrospective analysis was performed of collected data on CLI patients treated with EVT between April 2007 and December 2015. All patients were classified according to their wound status, ischemia index, and extent of foot infection into the following four groups: very low risk, low risk, moderate risk, and high risk. Comorbidities and vascular lesions in each group were analyzed. The prognostic value of the WIfI classification was analyzed on the basis of the wound healing rate and amputation-free survival at 1 year.
This study included 163 consecutive CLI patients who underwent HD and successful endovascular intervention. The rate of the high-risk group (36%) was the highest among the four groups, and the proportions of very-low-risk, low-risk, and moderate-risk patients were 10%, 18%, and 34%, respectively. The mean follow-up duration was 784 ± 650 days. The wound healing rates at 1 year were 92%, 70%, 75%, and 42% in the very-low-risk, low-risk, moderate-risk, and high-risk groups, respectively (P <.01). A similar trend was observed for the 1-year amputation-free survival among the groups (76%, 58%, 61%, and 46%, respectively; P = .02).
The WIfI classification system predicted the wound healing and amputation risks in a highly selected group of HD patients with CLI treated with EVT, with a statistically significant difference between high-risk patients and other patients.
To investigate the usefulness of ultrasound-guided (USG) intraluminal approach for femoropopliteal (FP) lesion. 64 patients (73 limbs) with de novo long occlusive (> 15 cm) FP lesions underwent USG ...intralumial approach from April 2012 to October 2016. Periprocedural intravascular ultrasound findings were collected. Clinical outcome and predictors of restenosis after USG intraluminal approach for de novo long occlusive FP lesion were investigated. Among the study participants, 34% were female, 50% had diabetes mellitus, and 10% received hemodialysis. Lesion and chronic total occlusion (CTO) lengths were 222 ± 55 mm and 201 ± 55 mm, respectively. Procedural success was achieved in 72 lesions (99%). Distal puncture was performed in 7 limbs (10%). The proportion of within-CTO intraplaque, subintimal, and medial routes were 87 ± 21%, 9 ± 15%, and 4 ± 11%, respectively. Primary patency was 71% and 69% at 1 and 2 years. Multivariate analysis revealed that within-CTO intraplaque route proportion hazard ratio (HR) 0.81; 95% confidence interval (CI) 0.67–0.98,
p
= 0.0339 and lesion length (HR 1.11; CI 1.00–1.22;
p
= 0.0447) were independent predictors of restenosis.USG intraluminal approach facilitated acquisition of within-CTO intraplaque route in long occlusive FP lesions and could improve clinical outcome.
The relationship between severity of calcification and clinical outcomes after endovascular therapy (EVT) for femoropopliteal lesions is well known. We often encounter dense calcifications in our ...daily practice, which are darker than normal calcifications on angiography. Accordingly, we named it “black rock” (BR), and investigated its impact on clinical outcomes after EVT. We retrospectively analyzed 677 lesions in 495 patients who underwent EVT for de novo calcified femoropopliteal lesions at our hospital between April 2007 and June 2020. BR is defined as a calcification which is 1 cm or more in length, occupies more than half of the vessel diameter, and appears darker than the body of the femur on angiography. Propensity score matching analysis was performed to compare clinical outcomes between lesions with BR BR (+) group and without BR BR (−) group. A total of 119 matched pairs of lesions were analyzed. Primary patency at 2 years was significantly lower in the BR (+) group than in the BR (−) group (48% vs. 75%, p = .0007). Multivariate analysis revealed that the presence of BR hazard ratio (HR) = 2.23, 95% confidence interval (CI); 1.48–3.38, p = .0001, lesion length (HR = 1.03, 95%CI; 1.00–1.06, p = .0244), and no scaffold use (HR = 1.58, 95%CI; 1.06–2.36, p = .0246) were predictors of restenosis. The presence of BR is independently associated with clinical outcomes after EVT for de novo calcified femoropopliteal lesions.
•Malnutrition predicts poor outcome after transcatheter aortic valve replacement.•Malnutrition provided complementary prognostic value to the Clinical Frailty Scale.•Intervention to nutritional ...status may be potentially beneficial for prognosis.
This study aimed to elucidate the prognostic value of objective nutritional status after transcatheter aortic valve replacement (TAVR).
This study enrolled 150 consecutive patients who underwent TAVR between February 2014 and March 2017. Nutritional status was assessed using the Controlling Nutritional Status (CONUT) score before TAVR. Patients were divided into a high CONUT score (malnutrition status >4 points, n=30) or low CONUT score (normal nutritional status 1–4 points, n=120) group. The primary endpoint was mortality within 1-year post-TAVR.
Patients in the high CONUT group were characterized by low body mass index (kg/m2) (20.3±2.4 vs. 22.8±3.5, p<0.001), a higher prevalence of atrial fibrillation (43% vs. 23%, p=0.03), and more common frailty median (interquartile range) Clinical Frailty Scale (CFS) score, 4.5 (3.75–6) vs. 4 (3–5), p<0.001. Mortality rate within 1-year post-TAVR was significantly higher in the high CONUT group (43.6% vs. 6.7%, p<0.001). High CONUT score was independently associated with poor prognosis post-TAVR adjusted hazard ratio, 8.20; 95% confidence interval (CI), 3.10–22.6; p<0.001. On integrated discrimination improvement (IDI) analysis, malnutrition status improved CFS for predicting mortality post-TAVR (IDI, 0.15; 95% CI, 0.07–0.23; p<0.001).
Objective malnutrition status was predictive of mortality post-TAVR and provided complementary prognostic information to the CFS. Thus, objective nutritional status may refine the clinical risk stratification of patients who undergo TAVR.
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