Transcatheter aortic valve replacement in patients with severe comorbidities: A retrospective cohort study.

OBJECTIVE: To investigate the long-term outcomes of patients with severe comorbidities (sCM) undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: The benefit of TAVR may be limited among patients with sCM due to a lack of mortality- or quality-of-life-benefit. METHODS: All TAVR patients in the Allina Health System between January 1, 2011 and August 7, 2018 were included (n = 890, 82 ± 8 years, 55% men). sCM included: severe lung disease, severe liver disease, end-stage renal disease, severe, severe dementia, severe dilated cardiomyopathy, and frailty. Outcomes between patients with (n = 215, 24%) and without (n = 675, 76%) sCM were compared. RESULTS: At baseline, patients with sCM had worse symptoms, higher STS-PROM and a lower Kansas City Cardiomyopathy Questionnaire (KCCQ) score compared to those without. During a median follow-up of 15 months (IQR, 7-29 months), there were 208 (23%) deaths. Patients with sCM had a lower 3-year survival free from all-cause mortality (40% vs. 79%, p < .001), and lower 3-year survival free from the composite endpoint of all-cause mortality, re-hospitalization for heart failure, myocardial infarction or stroke (31% vs. 64%, p < .001) compared to those without sCM. The estimated monthly increase in KCCQ scores following TAVR was 1.5, 95%CI (1.3, 1.7), p < .001 irrespective of sCM grouping. From Cox regression analysis, severe comorbidities, with the exception of liver disease, were associated with an increased risk of all-cause mortality and any additional comorbidity was associated with a multiplicative increase in risk of mortality of 2.8 (95%CI 2.3, 3.6), p < .001. CONCLUSIONS: TAVR patients with sCM have poor 3-year outcomes but may experience improvements in their quality of life.

Identification of Subclinical Myocardial Dysfunction and Association with Survival after Transcatheter Mitral Valve Repair.

BACKGROUND: Transcatheter mitral valve repair (TMVr) using edge-to-edge mitral valve clip is effective for patients with mitral regurgitation (MR) and high or prohibitive surgical risk. Global longitudinal strain (GLS) allows evaluation of subclinical myocardial dysfunction, but its incremental clinical utility into risk stratification, beyond traditional clinical parameters, is unknown in patients treated with TMVr. We sought to evaluate the association of baseline GLS with 1-year all-cause mortality in patients treated with TMVr using edge-to-edge mitral valve clip. METHODS: We analyzed 155 patients who underwent transcatheter edge-to-edge mitral valve clip implantation (mean age, 83 ± 7 years; 48% were women; mean left ventricular ejection fraction, 56% ± 10%, Society of Thoracic Surgeons Predicted Risk of Mortality score for repair, 6.62% ± 5.22%). Baseline left ventricular GLS was obtained by two-dimensional speckle-tracking echocardiography, averaging 18 segments from three apical views. Receiver operating characteristic analyses were used to assess the GLS cut point associated with all-cause mortality. Multivariable models with Cox regression tested its relationship after adjustment for baseline comorbidities. RESULTS: During a median follow-up of 316 days, all-cause deaths occurred in 30 patients at a median of 156 days after TMVr. The area under the curve of preoperative GLS associated with the outcome was 0.60, with a cutoff point of -14.5%. Baseline GLS > -14.5% was associated with 1-year mortality (hazard ratio = 2.50; 95% CI, 1.20-5.21; P = .02) before and after adjustment for baseline characteristics. After accounting for baseline characteristics, patients with GLS > -14.5% had worse 1-year mortality than those with GLS ≤ -14.5% (χ2P < .001). In nested Cox proportional hazards models, the addition of baseline GLS to Society of Thoracic Surgeons Predicted Risk of Mortality score, left ventricular ejection fraction, and the etiology of MR significantly increased the model χ2 value (χ2 = 12.32). CONCLUSIONS: Baseline GLS is independently associated with 1-year all-cause mortality in patients who undergo TMVr, and its assessment improves risk stratification in these patients.

Impact of the Commercial Introduction of Transcatheter Mitral Valve Repair on Mitral Surgical Practice.

Background There has been uncertainty regarding the effect of transcatheter mitral valve repair (TMVr) with MitraClip on cardiac surgical practice. Our aim was to examine the impact of the commercial introduction of TMVr to a comprehensive mitral program. Methods and Results We evaluated 875 patients (aged 69±14 years; 58% men) who underwent transcatheter or mitral surgical procedures over a 6-year period at our institution. Main outcomes were changes in surgical procedural volume after TMVr introduction and short-term mortality for surgical and TMVr procedures. The numbers of patients treated with MitraClip, isolated mitral repair, and any mitral surgery were 249, 292, and 626 patients, respectively. Compared with surgery, patients with MitraClip were older (aged 82±8 versus 64±12 years; P<0.001) and had more severe morbidity. Following the introduction of MitraClip, surgical volumes steadily increased to a rate of 10 (95% CI, 3-7) procedures per year for isolated mitral procedures and 17 (95% CI, 13-20) procedures per year for all mitral surgeries. Both MitraClip and surgical volumes increased at the same rate (P=0.42). In-hospital mortality was 3.2% for MitraClip and 2.1% for all mitral surgeries (P=0.33). At 30 days, survival free of all mortality (P=0.17) and freedom from heart failure rehospitalization (P=0.75) were similar for transcatheter and surgical procedures. Conclusions The commercial introduction of TMVr may be associated with growth in cardiac surgery, without detracting from other therapies, and favorable clinical outcomes for all treated mitral regurgitation patients. These findings demonstrate the potential benefits of complementary therapies in the treatment of patients with mitral regurgitation.

Transcatheter therapy for residual mitral regurgitation after MitraClip therapy.

AIMS: We aimed to examine the effectiveness and the optimal technique for transcatheter therapy for residual mitral regurgitation (MR) after MitraClip therapy with the AMPLATZER Vascular Plug II (AVP-II). METHODS AND RESULTS: Nine patients (mean age, 78±4 years) underwent transcatheter therapy with the AVP-II for residual MR after MitraClip therapy. We examined procedural, in-hospital, and 30-day outcomes. Our technique was successful in all cases, with treatment of different types of residual MR, including paraclip, interclip, and leaflet perforation. MR grade decreased significantly from 4+ to 1+ (p<0.0001), with final residual MR being mild or none in seven patients. Mitral stenosis did not occur with plug placement. The optimal deployment technique for reduction of MR was placement with only one segment on the left atrial side of the mitral valve leaflets (n=8). During clinical follow-up (median 155 days), symptom improvement had occurred in all patients (NYHA class, baseline vs follow-up, 3.2±0.4 vs 2.3±0.8; p=0.01) with mild or no symptoms in six patients. There was no procedural mortality, major adverse event(s), device embolisation, haemolysis or need for cardiac surgery. CONCLUSIONS: For patients with residual MR after MitraClip therapy, this technique may be effective and safe, especially when deployed with only one segment on the left atrial side of the mitral leaflets.

Transcatheter Mitral Valve Replacement with Tendyne.

Mitral regurgitation is the most commonly occurring valvular heart disease in developed countries. Transcatheter mitral valve replacement (TMVR) has emerged as a novel potential therapy for patients with severe mitral valve disease who are unsuitable candidates for conventional surgery or transcatheter edge-to-edge mitral repair. TMVR with the Tendyne prosthesis has shown potential at short-term follow-up to be an effective and safe treatment alternative for high-risk patients with severe mitral valve disease.

Causes and Clinical Outcomes of Patients Who Are Ineligible for Transcatheter Mitral Valve Replacement.

OBJECTIVES: The aim of this study was to gain insight into the causes and outcomes of patients who do not qualify for transcatheter mitral valve replacement (TMVR). BACKGROUND: Despite the increasing availability of TMVR, patients with severe mitral regurgitation may not be eligible. Thus far, no investigation has examined ineligible patients and their clinical outcomes. METHODS: A total of 203 patients (mean age 79 ± 9 years, 48% men) who were ineligible for participation in early feasibility studies of TMVR were examined. RESULTS: The ineligibility rate for TMVR was 89.0%. The most common reasons for TMVR exclusion were excessive frailty (15.3%), severe tricuspid regurgitation (15.3%), and prior aortic valve therapy (14.2%). Mitral anatomic exclusions were present in 15.8%, with severe annular calcification in 7.4%, and risk for left ventricular outflow tract obstruction was notably infrequent (4.4%). Overall, 76 patients (37.4%) did not undergo subsequent commercial surgical or transcatheter mitral therapy. Patients not eligible for TMVR and not treated commercially had high rates of cardiac death (11.8%) and death or heart failure hospitalization (22.4%) at 1 year. These rates were significantly higher than those who underwent surgery (2.4% for cardiac death; p < 0.001; 5.5% for heart failure hospitalization; p = 0.003) and remained worse after excluding patients with excessive frailty or medical futility and in multivariate modeling that adjusted for baseline differences. CONCLUSIONS: Patients ineligible for TMVR and treated medically have poor outcomes. These data and the high rate of TMVR screen failure support the need for therapy iteration as well as development of alternative means of management, with the goal of improving the prognosis of these patients.

Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses, failed annuloplasty rings, and mitral annular calcification.

Aims: We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)]. Methods and results: From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0 ± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P < 0.001), whereas second valve implantation was more frequent in ViR compared with ViMAC and ViV (12.1% vs. 5.2% vs. 2.5%; P < 0.001). Accordingly, technical success rate was higher after ViV compared with ViR and ViMAC (94.4% vs. 80.9% vs. 62.1%; P < 0.001). Compared with ViMAC and ViV groups, ViR group had more frequent post-procedural mitral regurgitation ≥moderate (18.4% vs. 13.8% vs. 5.6%; P < 0.001) and subsequent paravalvular leak closure (7.8% vs. 0.0% vs. 2.2%; P = 0.006). All-cause mortality was higher after ViMAC compared with ViR and ViV at 30 days (34.5% vs. 9.9% vs. 6.2%; log-rank P < 0.001) and 1 year (62.8% vs. 30.6% vs. 14.0%; log-rank P < 0.001). On multivariable analysis, patients with failed annuloplasty rings and severe MAC were at increased risk of mortality after TMVR [ViR vs. ViV, hazard ratio (HR) 1.99, 95% confidence interval (CI) 1.27-3.12; P = 0.003; ViMAC vs. ViV, HR 5.29, 95% CI 3.29-8.51; P < 0.001]. Conclusion: The TMVR provided excellent outcomes for patients with degenerated bioprostheses despite high surgical risk. However, ViR and ViMAC were associated with higher rates of adverse events and mid-term mortality compared with ViV.

Prospective Evaluation for Hypoattenuated Leaflet Thickening Following Transcatheter Aortic Valve Implantation.

Prospective investigations for the frequency of hypoattenuated leaflet thickening (HALT) and its clinical implications in transcatheter aortic valve implantation (TAVI) patients are limited. We initiated a prospective screening program of TAVI patients for HALT beginning in July 2015. Eligible patients were evaluated with gated, contrast-enhanced multidetector computed tomography within 30 days of TAVI, and examined for HALT and clinical outcomes. During the study period, 287 patients (81 ± 8 years; 53% men) who underwent TAVI with commercially approved devices were examined. Overall, 26 patients (9.1%) had occurrence of HALT, and only one of these patients had detectable hemodynamic changes on echocardiography at diagnosis. Notably, 9 of 26 HALT patients had been receiving warfarin, however, the HALT patients more often had subtherapeutic international normalized ratio whereas using warfarin than patients without HALT on index multidetector computed tomography imaging (p = 0.01). Patients who developed HALT had lower baseline aortic gradient, valvuloarterial impedance, and peak aortic velocity, and more commonly had been treated with balloon-expandable valves (73% of all HALT cases) with a higher incidence among those who received larger prostheses. All patients with HALT were placed on anticoagulation at diagnosis, and valvular function remained unchanged at follow-up. Two patients with HALT (7.7%) experienced ischemic stroke. A statistical trend for more major adverse clinical events was present in HALT patients. In conclusion, HALT was detected in 9% of TAVI cases in this prospective observational cohort, with a greater frequency in patients with large, balloon-expandable prostheses. Prospective screening may be considered as early HALT is reversible by timely therapeutic anticoagulation.

Contemporary Reasons and Clinical Outcomes for Patients With Severe, Symptomatic Aortic Stenosis Not Undergoing Aortic Valve Replacement.

BACKGROUND: Although aortic valve replacement (AVR) can be lifesaving, many patients with symptomatic aortic stenosis do not undergo appropriate therapy. This study sought to examine the characteristics, outcomes, and reasons for not pursuing AVR in a contemporary cohort. METHODS AND RESULTS: We examined 548 patients with severe, symptomatic aortic stenosis not treated with AVR through March 2017. Patients were grouped according to AVR appropriateness based on the presence of medical futility. Demographics, rationale for no AVR therapy, and outcomes were assessed. There were 359 (65.5%) potentially appropriate candidates for AVR and 189 (34.5%) others patients with futility. Among potentially appropriate patients, 62.1% had severe symptoms, 74.4% had not been referred for AVR, and 40.1% were low risk. Patient refusal was common (54.6%), with incorrect symptom assignment or aortic stenosis severity classification accounting for nearly all other explanations. Compared with patients with futility, potentially appropriate AVR patients had lower rates of both referral to cardiology or surgery (85.2% versus 92.6%; P=0.01) and complete heart team evaluations (10.6% versus 17.5%; P=0.02). Palliative consultation occurred in only 124 patients (22.6%) overall and in only 10.0% of those without futility. Overall, the 1-year mortality was 54.7%, with heart failure hospitalization occurring in 19.3%. CONCLUSIONS: In this contemporary study, two-thirds of patients with symptomatic aortic stenosis treated medically were potentially appropriate AVR candidates and had poor outcomes. Most had incomplete heart team evaluations, commonly had severe symptoms or lesion severity misinterpreted, and were not evaluated by palliative care. Given the potential for beneficial outcomes among those untreated, further efforts to address these shortcomings are needed.

Congenital Absence of Left Atrial Appendage Diagnosed by Multimodality Imaging.

A 70-years-old male with a history of hypertension and drug resistant paroxysmal atrial fibrillation (AF) presented to our hospital for catheter ablation to his symptomatic AF. He had no prior surgical or percutaneous procedure to close or exclude the left atrial appendage (LAA). A transesophageal echocardiography (TEE) was performed to rule out intra-cardiac thrombus prior to the ablation procedure. Although the TEE imaging at multiple acquisition angles was obtained, the LAA could not be visualized and an absence of the LAA was suspected. An absence of the LAA was confirmed using cardiac computed tomography (CT), which included 3D reconstruction. Additionally, the LAA was not visualized with left atrium (LA) angiography. During the ablation procedure, 3D voltage mapping in LA was created and no low voltage area or abnormal potential was recorded around the usual root location of the LAA. Successful electrical pulmonary vein isolation was achieved with no major complications. After six months of follow-up, the patient remained in sinus rhythm without any antiarrhythmic drugs and showed no related clinical symptoms. He stopped his anticoagulation therapy due to lack of evidence of AF recurrence and an absence of LAA. Multimodality imaging allowed us to identify the congenital absence of LAA.

In-hospital mortality analysis of Japanese patients with acute coronary syndrome using the Tokyo CCU Network database: Applicability of the GRACE risk score.

BACKGROUND: The GRACE risk score was developed to predict in-hospital mortality for acute coronary syndrome (ACS) using multinational registries, but did not include Japanese data. Therefore, GRACE risk scores are not extensively used in Japan. The present study aimed to evaluate the relationship between the GRACE risk score and in-hospital mortality among Japanese patients with ACS using the Tokyo CCU (cardiovascular care unit) Network Database. METHODS AND RESULTS: A total of 9460 patients with ACS hospitalized at 67 Tokyo CCUs between January 2011 and December 2013 were retrospectively reviewed and GRACE risk scores were calculated. Patients in the Tokyo CCU Network database had more severe conditions compared to those of the original GRACE study. There was a strong correlation between the GRACE risk score and in-hospital mortality for patients with ST-segment elevation myocardial infarction (STEMI) or non ST-segment elevation myocardial infarction (NSTEMI) (r=0.99, p<0.001); however, the correlation was not significant for patients with unstable angina (r=0.35, p=0.126). For STEMI+NSTEMI patients, the discrimination ability of the GRACE risk score was excellent, with a c statistic of 0.87 (95% confidence interval, 0.86-0.89). CONCLUSIONS: The GRACE risk score is a good predictor of in-hospital mortality for Japanese patients with STEMI or NSTEMI, and can help clinicians stratify patients by risk for optimal patient triage and early treatment management.

Clinical utility of early use of tolvaptan in very elderly patients with acute decompensated heart failure.

OBJECTIVE: The establishment of an optimal strategy for elderly patients with acute decompensated heart failure (ADHF) is currently an important issue. Particularly in very elderly (VE) patients, ADHF is associated with a poor prognosis. We therefore aimed to evaluate the efficacy and safety of the early use of tolvaptan (TLV) in VE patients. METHODS: Of 245 patients with ADHF admitted between March 2013 and July 2014, we prospectively enrolled 111 patients with TLV first administered within 24 h of hospitalization. These were divided into two groups according to the age: VE (≥85 years, n=45) and not very elderly (NVE, <85 years, n=66). The endpoints were the incidence of worsening renal function, death by any cause, or the length of hospital stay. RESULTS: There were no significant differences between the two groups in the incidence of worsening renal function (26.7% in VE vs. 25.8% in not VE, p=0.92), dose of TLV after hospitalization (7.4±0.7 vs. 7.5±1.3 mg/day, p=0.63), mean duration of the use of TLV (4.3±3.5 vs. 5.4±4.8 days, p=0.17), or mean length of hospital stay (16.5±7.8 vs. 15.7±8.0 days, p=0.64). CONCLUSION: TLV shows similar efficacy and safety in both VE and NVE groups. Even for VE patients with ADHF, initiation of TLV with standard diuretic treatment may have the potential not to increase the incidence of worsening renal function.

The Successful Removal of Two Retrievable Inferior Vena Cava (IVC) Filters after 67 Days in a Patient with a Double IVC.

We herein present a case in which two retrievable inferior vena cava (IVC) filters, which were implanted to treat deep-vein thrombosis caused by the compression of a double IVC, were successfully removed on the 67th day after placement. The filters were individually placed in both the left and right IVCs. With a prevalence of only 0.2%, a double IVC is an extremely rare anatomical variation. The long-term effects of IVC filters are unknown, and the placement of a filter potentially introduces the risk of complications. Thus, if the patient's clinical condition allows, the endovascular retrieval of the filter should be considered within a few months after implantation.