Francisco Campelo-Parada

Incidence, Timing, and Predictors of Valve Hemodynamic Deterioration After Transcatheter Aortic Valve Replacement: Multicenter Registry.

BACKGROUND Scarce data exist on the incidence of and factors associated with valve hemodynamic deterioration (VHD) after transcatheter aortic valve replacement (TAVR). OBJECTIVES This study sought to determine the incidence, timing, and predictors of VHD in a large cohort of patients undergoing TAVR. METHODS This multicenter registry included 1,521 patients (48% male; 80 ± 7 years of age) who underwent TAVR. Mean echocardiographic follow-up was 20 ± 13 months (minimum: 6 months). Echocardiographic examinations were performed at discharge, at 6 to 12 months, and yearly thereafter. Annualized changes in mean gradient (mm Hg/year) were calculated by dividing the difference between the mean gradient at last follow-up and the gradient at discharge by the time between examinations. VHD was defined as a ≥10 mm Hg increase in transprosthetic mean gradient during follow-up compared with discharge assessment. RESULTS The overall mean annualized rate of transprosthetic gradient progression during follow-up was 0.30 ± 4.99 mm Hg/year. A total of 68 patients met criteria of VHD (incidence: 4.5% during follow-up). The absence of anticoagulation therapy at hospital discharge (p = 0.002), a valve-in-valve (TAVR in a surgical valve) procedure (p = 0.032), the use of a 23-mm valve (p = 0.016), and a greater body mass index (p = 0.001) were independent predictors of VHD. CONCLUSIONS There was a mild but significant increase in transvalvular gradients over time after TAVR. The lack of anticoagulation therapy, a valve-in-valve procedure, a greater body mass index, and the use of a 23-mm transcatheter valve were associated with higher rates of VHD post-TAVR. Further prospective studies are required to determine whether a specific antithrombotic therapy post-TAVR may reduce the risk of VHD.

Transcatheter Therapies for Treating Tricuspid Regurgitation.

Tricuspid valve (TV) disease has been relatively neglected, despite the known association between severe tricuspid regurgitation (TR) and mortality. Few patients undergo isolated tricuspid surgery, which remains associated with high in-hospital mortality rates, particularly in patients with prior left-sided valve surgery. Patients with severe TR are often managed medically for years before TV repair or replacement. Current guidelines recommend TV repair in the presence of a dilated tricuspid annulus at the time of a left-sided valve surgical intervention, even if regurgitation is mild. This proposed algorithm aims to prevent the inevitable progression to severe TR and the need for a second surgical intervention. Recently, novel transcatheter treatment options were developed for treating patients with severe TR and right heart failure with prohibitive surgical risk. Here we describe currently available transcatheter treatment options for severe TR implanted at different levels: the junction between vena cavae and right atrium; the tricuspid annulus; or between TV leaflets, improving coaptation.

First-in-man Experience of a Novel Transcatheter Repair System for Treating Severe Tricuspid Regurgitation

BACKGROUND Isolated tricuspid valve surgery is associated with high morbidity and mortality, especially in patients with prior cardiac surgery. The transcatheter Forma Repair System (Edwards Lifesciences, Irvine, California) is designed to provide a surface for native leaflet coaptation to reduce tricuspid regurgitation (TR) by occupying the regurgitant orifice area. OBJECTIVES This study sought to evaluate the feasibility and exploratory efficacy with this transcatheter repair system for the treatment of severe TR. METHODS Seven high-risk patients with severe TR and clinical signs of heart failure were declined for surgery and offered transcatheter treatment with this device. All procedures were performed within a cardiac catheterization laboratory or hybrid operating room under general anesthesia with transesophageal echocardiographic guidance. Vascular access was via the left axillary vein. Baseline characteristics, procedural and in-hospital outcomes, as well as 30-day follow-up were prospectively collected. RESULTS All patients had severe TR and New York Heart Association (NYHA) functional class II to IV (mean age 76 ± 13 years; mean logistic EuroSCORE 25.7 ± 17.4%), and underwent device implantation to improve tricuspid leaflet coaptation, thereby reducing TR. Device implantation was successful without procedural complications in all patients, with significant reductions in TR severity (moderate in 3 patients and mild in 4 patients). Median hospital length of stay was 4 days. At 30-day follow-up, all patients but 1 demonstrated improvements in NYHA functional status (to class II) with pronounced reductions in the presence and severity of peripheral edema. TR severity was assessed as being moderate at 30-day transthoracic echocardiography follow-up in all patients. No complications related to the device or vascular access were observed during follow-up. CONCLUSIONS A transcatheter-based treatment option for severe TR appears safe and feasible with this repair system. Improvements in TR severity were documented in all patients, which were accompanied by improvements in peripheral edema and functional status.

Impact of New-Onset Left Bundle Branch Block and Periprocedural Permanent Pacemaker Implantation on Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis.

Background—Available data on the clinical impact of new-onset left bundle branch block (LBBB) and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) remains controversial. We aimed to evaluate the impact of (1) periprocedural new-onset LBBB or PPI post-TAVR on cardiac mortality and all-cause 1-year mortality and (2) new-onset LBBB on the need for PPI at 1-year follow-up. Methods and Results—We performed a systematic search from PubMed and EMBASE databases for studies reporting raw data on new-onset LBBB post-TAVR and the need for PPI or mortality at 1-year follow-up, or on 1-year mortality according to the need for periprocedural PPI post-TAVR. Data from 17 studies, including 4756 patients (8 studies) and 7032 patients (11 studies) for the evaluation of the impact of new-onset LBBB and periprocedural PPI post-TAVR were sourced, respectively (with 2 studies used for both outcomes). New-onset LBBB post-TAVR was associated with a higher risk of PPI (risk ratio [RR], 2.18; 95% confidence interval [CI], 1.28–3.70) and cardiac death (RR, 1.39; 95% CI, 1.04–1.86) during follow-up, as well with a tendency toward an increase in all-cause mortality (RR, 1.21; 95% CI, 0.98–1.50). Periprocedural PPI post-TAVR was not associated with any increased risk of all-cause mortality at 1 year (RR, 1.03; 95% CI, 0.9–1.18), yet a tendency toward a protective effect on cardiac death was observed (RR, 0.78; 95% CI, 0.60–1.03). Conclusions—New-onset LBBB post-TAVR is a marker of an increased risk of cardiac death and need for PPI at 1-year follow-up. The need for PPI early post-TAVR did not increase the risk of death.

Unidirectional left-to-right interatrial shunting for treatment of patients with heart failure with reduced ejection fraction: a safety and proof-of-principle cohort study.

BACKGROUND In patients with heart failure, interventions to reduce elevated left atrial pressure improve symptoms and reduce the risk of hospital admission. We aimed to assess the safety and potential efficacy of therapeutic left-to-right interatrial shunting in patients with heart failure with reduced ejection fraction. METHODS We did this proof-of-principle cohort study at one centre in Canada. Patients (aged ≥18 years) with New York Heart Association (NYHA) class III chronic heart failure with reduced ejection fraction were enrolled under the Canadian special access programme. Shunt implants were done after transseptal catheterisation with transoesophageal echocardiographic guidance under general anaesthesia. Patients had clinical and echocardiography evaluations at baseline and months 1 and 3 after shunt implantation. FINDINGS Between Oct 10, 2013, and March 27, 2015, we enrolled ten patients. The device was successfully implanted in all patients; no device-related or procedural adverse events occurred during follow-up. Transoesophageal echocardiography at 1 month showed that all shunts were patent, with no thrombosis or migration. From baseline to 3 month follow-up, we recorded improvements in NYHA classification (from class III to class II in seven [78%] of nine patients, from class III to class I in one [11%] patient, and no change in one [11%] patient; p=0·0004); quality of life, as assessed by the Duke Activity Status Index (from a mean score of 13 [SD 6·2] to 24·8 [12·9]; p=0·016) and the Kansas City Cardiomyopathy Questionnaire (from a mean score of 44·3 [SD 9·8] to 79·1 [13·0]; p=0·0001); and 6 min walk test distance (from a mean of 244 m [SD 112] to 318 m [134]; p=0·016). Pulmonary capillary wedge pressure was reduced from a mean of 23 mm Hg (SD 5) at baseline to 17 mm Hg (8) at 3 months (p=0·035), with no changes in right atrial pressure, pulmonary arterial pressure, or pulmonary resistance. No patient was admitted to hospital for worsening heart failure. One (10%) patient was admitted to hospital with gastrointestinal bleeding at month 1; one (10%) patient died after incessant ventricular tachycardia storm, which led to terminal heart failure 2 months post-procedure. INTERPRETATION This first-in-man experience with an implanted left-to-right interatrial shunt demonstrates initial safety and early beneficial clinical and haemodynamic outcomes in patients with heart failure with reduced ejection fraction. Further large-scale randomised studies are warranted. FUNDING V-Wave.

Initial Experience of Transcatheter Mitral Valve Replacement With a Novel Transcatheter Mitral Valve: Procedural and 6-Month Follow-Up Results

BACKGROUND There are scarce data available on transcatheter mitral valve replacement (TMVR), and these have been limited to procedural results, with no follow-up status reported. OBJECTIVES The goal of this study was to evaluate the feasibility, procedural results, and 6-month follow-up outcomes after TMVR with a mitral transcatheter heart valve (Fortis, Edwards Lifesciences, Irvine, California). METHODS We report a series of 3 patients (mean age 71 ± 9 years, 2 men) who had TMVR under a compassionate clinical use program. All patients treated had functional mitral regurgitation (MR) secondary to ischemic cardiomyopathy (prior bypass surgery in all cases; left ventricular ejection fraction between 25% and 30%) and were considered to be at very high surgical risk (mean Society of Thoracic Surgeons score: 9.3). RESULTS The procedure was performed through the transapical approach, and the valve was successfully implanted in all cases, with no major complications. At hospital discharge, echocardiographic evaluation revealed trace residual MR in 2 patients and no MR in 1 patient. The mean transvalvular mitral gradient was ≤4 mm Hg in all patients. At the 3-month follow-up, the valve function remained unchanged, and transesophageal echocardiography and computed tomography showed no structural failures. All patients had improvements in functional status, in exercise capacity as evaluated by 6-min walk test, and in quality of life. At 6-month follow-up, all patients remain alive, without hospital readmission for heart failure and with New York Heart Association functional class ≤II. CONCLUSIONS TMVR with this valve is feasible and is associated with good outcomes. Optimal valve functional results were obtained acutely and were sustained at 6-month follow-up in all patients. Further studies with a larger number of patients and longer follow-up are warranted.

Prognostic Value of Fat Mass and Skeletal Muscle Mass Determined by Computed Tomography in Patients Who Underwent Transcatheter Aortic Valve Implantation

Body composition (fat mass [FM] and skeletal muscle mass [SMM]) predicts clinical outcomes. In particular, loss of SMM (sarcopenia) is associated with frailty and mortality. There are no data on the prevalence and impact of FM and SMM in patients undergoing transcatheter aortic valve implantation (TAVI). The objective of this study is to determine body composition from pre-TAVI computed tomography (CT) and evaluate its association with clinical outcomes in patients who underwent TAVI. A total of 460 patients (mean age 81 ± 8 years, men: 51%) were included. Pre-TAVI CTs of the aorto-ilio-femoral axis were analyzed for FM and SMM cross-sectional area at the level of the third lumbar vertebrae (L3). Regression equations correlating cross-sectional area at L3 to total body FM and SMM were used to determine prevalence of sarcopenia, obesity, and sarcopenic obesity in patients (64%, 65%, and 46%, respectively). Most TAVI procedures were performed through a transfemoral approach (59%) using a balloon-expandable valve (94%). The 30-day and mid-term (median 12 months [interquartile range 6 to 27]) mortality rates were 6.1% and 29.6%, respectively. FM had no association with clinical outcomes, but sarcopenia predicted cumulative mortality (hazard ratio 1.55, 95% confidence interval 1.02 to 2.36, p = 0.04). In conclusion, body composition analysis from pre-TAVI CT is feasible. Sarcopenia, obesity, and sarcopenic obesity are prevalent in the TAVI population, with sarcopenia predictive of cumulative mortality.

Self-expanding Portico Valve Versus Balloon-expandable SAPIEN XT Valve in Patients With Small Aortic Annuli: Comparison of Hemodynamic Performance

INTRODUCTION AND OBJECTIVES The self-expanding Portico valve is a new transcatheter aortic valve system yielding promising preliminary results, yet there are no comparative data against earlier generation transcatheter aortic valve systems. The aim of this study was to compare the hemodynamic performance of the Portico and balloon-expandable SAPIEN XT valves in a case-matched study with echocardiographic core laboratory analysis. METHODS Twenty-two patients underwent transcatheter aortic valve implantation with the Portico 23-mm valve and were matched for aortic annulus area and mean diameter measured by multidetector computed tomography, left ventricular ejection fraction, body surface area, and body mass index with 40 patients treated with the 23-mm SAPIEN XT. Mean aortic annulus diameters were 19.6±1.3mm by transthoracic echocardiography and 21.4±1.2mm by computed tomography, with no significant between-group differences. Doppler echocardiographic images were collected at baseline and at 1-month of follow-up and were analyzed in a central echocardiography core laboratory. RESULTS There were no significant between-group differences in residual mean transaortic gradients (SAPIEN XT: 10.4±3.7mmHg; Portico: 9.8±1.1mmHg; P=.49) and effective orifice areas (SAPIEN XT: 1.36±0.27cm(2); Portico, 1.37±.29cm(2); P=.54). Rates of severe prosthesis-patient mismatch (effective orifice area<0.65cm(2)/m(2)) were similar (SAPIEN XT: 13.5%; Portico: 10.0%; P=.56). No between-group differences were found in the occurrence of moderate-severe paravalvular leaks (5.0% vs 4.8% of SAPIEN XT and Portico respectively; P=.90). CONCLUSIONS Transcatheter aortic valve implantation with the self-expanding Portico system yielded similar short-term hemodynamic performance compared with the balloon-expandable SAPIEN XT system for treating patients with severe aortic stenosis and small annuli. Further prospective studies with longer-term follow-up and in patients with larger aortic annuli are required.

Predictors and Association With Clinical Outcomes of the Changes in Exercise Capacity After Transcatheter Aortic Valve Replacement

Background: At present, there are no objective data specifically examining the clinical impact of variations in exercise capacity post–transcatheter aortic valve replacement (TAVR). We describe the changes in exercise capacity between baseline and 6 months post-TAVR, and ascertain factors associated with and clinical implications of a lack of improvement in exercise capacity post-TAVR. Methods: A total of 305 patients (mean age, 79±9 years; 44% men; Society of Thoracic Surgeons predicted risk mortality score, 6.7±4.2%) undergoing TAVR completed both baseline and follow-up exercise capacity assessments at 6 months post-TAVR. Exercise capacity was evaluated by the 6-minute walk test (6MWT). Clinical outcomes were compared between patients displaying greater than (n=152; improving group) versus less than (n=153; nonimproving group) the median percentage change in distance walked between baseline and 6-month follow-up examinations. The primary outcome measure was clinical event rates, measured from the 6-month post-TAVR period onward. Further dichotomization according to baseline 6MWT distance (less than versus more than median walking distance, or slow walker versus fast walker) was also assessed. Results: The mean overall distances walked pre- and post-TAVR (6 months post-TAVR) were 204±119 and 263±116 m, respectively (&Dgr;6MWT=60±106 m), with 219 (72%) patients demonstrating an increase in their walking distance (median percentage increase of the entire population was 20% [interquartile range, 0%–80%]). Factors independently correlated with reduced exercise capacity improvement included a range of baseline clinical characteristics (older age, female sex, chronic obstructive pulmonary disease; P<0.05 for all), periprocedural major or life-threatening bleeding (P=0.009) and new-onset anemia at 6 months post-TAVR (P=0.009). Failure to improve the 6MWT distance by at least 20% was independently associated with all-cause mortality (P=0.002) and cardiovascular death or rehospitalization for cardiovascular causes (P=0.001). Baseline slow walkers who were able to improve the 6MWT distance presented with significantly better outcomes than nonimprovers (P=0.01 for all-cause mortality; P=0.001 for cardiovascular end point). Conclusions: Approximately one-third of patients undergoing TAVR did not improve their exercise capacity postprocedure. The lack of functional improvement post-TAVR was predicted by a mix of baseline and periprocedural factors translating into poorer clinical outcomes. These results suggest that systematically implementing exercise capacity assessment pre- and post-TAVR may help to improve patient risk stratification.

Feasibility, safety, and efficacy of transcatheter aortic valve replacement without balloon predilation: A systematic review and meta-analysis

To evaluate the feasibility, safety, and efficacy of direct transcatheter aortic valve replacement (TAVR), that is, TAVR without balloon predilation (BPD), by performing a systematic review and meta‐analysis of available evidence.