Comparison of MANTA versus Perclose Prostyle large-bore vascular closure devices during transcatheter aortic valve implantation.

BACKGROUND: New vascular closure devices (VCD) are being introduced for achieving hemostasis after transcatheter aortic valve implantation (TAVI). However, no safety or efficacy data have been published compared to other contemporary VCD. AIM: To compare the safety and efficacy of suture-based Perclose Prostyle as compared to plug-based MANTA device. METHODS: A total of 408 consecutive TAVI patients from two high volume TAVI centers were included in the present study. Patients were grouped according to VCD: Prostyle versus MANTA. Propensity score matching (PSM) and multivariable analysis were utilized to compare clinical endpoints between the two groups. The primary endpoint was any vascular complication (VC) according to VARC-3 criteria. RESULTS: After PSM, a total of 264 patients were analyzed, of them 132 in each group. Overall baseline characteristics of the two groups were comparable. Primary end-point was similar between MANTA as compared to Prostyle (16.7% vs. 15.3% respectively, p = 0.888). The main driver for VC among MANTA group were minor vascular complications (15.2%). Conversely, minor and major VC contributed equally to the primary endpoint among Prostyle group (7.6%) (p = 0.013). No outcome predictors were identified in multivariate analysis. CONCLUSIONS: VCD for transfemoral TAVI using the new-generation Prostyle device or the MANTA device achieved comparable VARC-3 VC rates.

Percutaneous coronary intervention with ridaforolimus eluting-stents in small vessel coronary artery disease.

INTRODUCTION: The ridaforolimus-eluting stent (RES) system uses a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. AIM OF STUDY: To assess the safety and efficacy of small diameter (2.25 mm) RES (EluNIR) in small coronary artery disease. METHODS: A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameter of ≥2.25 mm to ≤2.5 mm. The primary endpoint was combined device success, defined as final in-stent residual diameter stenosis <30%, without 30-day major adverse cardiovascular events (MACE). RESULTS: A total of 81 patients were enrolled in the study. Twenty-three patients (28%) had acute coronary syndrome (ACS) at presentation and 37 (46%) had prior myocardial infarction (MI). Most of the target lesions were located in the circumflex coronary artery (44%) and were classified as B2/C grade according to the American Heart Association/American College of Cardiology classification. The final mean minimal lumen diameter, mean reference vessel diameter, and mean residual percent diameter stenosis were 2.0 ± 0.2 mm, 2.3 ± 0.1 mm, and 14 + 6.6%, respectively. The primary endpoint of device success without 30-day MACE was achieved in 98.8% of the patients. Target lesion failure (TLF) at 6 months was 1.2%. Thirty-day and 1-year MACE rates were 1.2% and 2.5%, respectively. CONCLUSION: The EluNIR 2.25 mm stent shows excellent results in small coronary artery disease and adds another tool in the treatment of this complex lesion type.

Procedural and long-term outcome among patients undergoing expedited trans-catheter aortic valve replacement.

OBJECTIVE: Patients with rapidly deteriorating clinical status due to severe aortic stenosis are often referred for expedited transcatheter aortic valve replacement (TAVR). Data regarding the outcome of such interventions is limited. We aimed to evaluate the outcome of patients undergoing expedited TAVR. DESIGN AND SETTING: Data were derived from the Israeli Multicenter Registry. SUBJECTS: Subjects were divided into two groups based on procedure urgency: patients who were electively hospitalized for the procedure (N = 3140) and those who had an expedited TAVR (N = 142). Procedural and periprocedural complication rates were significantly higher among patients with an expedited indication for TAVR compared to those having an elective procedure: valve malposition 4.6% versus 0.6% (p < 0.001), procedural cardiopulmonary resuscitation 4.3% versus 1.0% (p = 0.007), postprocedure myocardial infarction 2.0% versus 0.4% (p = 0.002), and stage 3 acute kidney injury 3.0% versus 1.1%, (p < 0.001). Patients with expedited indication for TAVR had significantly higher in hospital mortality (5.6% vs. 1.4%, p = 0.003). Kaplan-Meier's survival analysis showed that patients undergoing expedited TAVR had higher 3-year mortality rates compared to patients undergoing an elective TAVR procedure (p < 0.001). Multivariate analysis found that patients with expedited indication had fourfolds increased risk of in-hospital mortality (odds ratio: 4.07, p = 0.001), and nearly twofolds increased risk of mortality at 3-year (hazard ratio: 1.69, p = 0.001) compared to those having an elective procedure. CONCLUSION: Patients with expedited indications for TAVR suffer from poor short- and long-term outcomes. It is important to characterize and identify these patients before the deterioration to perform TAVR in a fast-track pathway to minimize their procedural risk.

Outcomes among patients admitted for non-ST-segment myocardial infarction in the pre-pandemic and pandemic COVID-19 era: Israel Nationwide study.

BACKGROUND: Since the beginning of the coronavirus disease 2019 (COVID-19) pandemic in 2019, several countries have reported a substantial drop in the number of patients admitted with non-ST-segment myocardial infarction (NSTEMI). OBJECTIVE: We aimed to evaluate the changes in admissions, in-hospital management and outcomes of patients with NSTEMI in the COVID-19 era in a nationwide survey. METHOD: A prospective, multicenter, observational, nationwide study involving 13 medical centers across Israel aimed to evaluate consecutive patients with NSTEMI admitted to intensive cardiac care units over an 8-week period during the COVID-19 outbreak and to compare them with NSTEMI patients admitted at the same period 2 years earlier (control period). RESULTS: There were 624 (43%) NSTEMI patients, of whom 349 (56%) were hospitalized during the COVID-19 era and 275 (44%) during the control period. There were no significant differences in age, gender and other baseline characteristics between the two study periods. During the COVID-19 era, more patients arrived at the hospital via an emergency medical system compared with the control period (P = 0.05). Time from symptom onset to hospital admission was longer in the COVID-19 era as compared with the control period [11.5 h (interquartile range, IQR, 2.5-46.7) vs. 2.9 h (IQR 1.7-6.8), respectively, P < 0.001]. Nevertheless, the time from hospital admission to reperfusion was similar in both groups. The rate of coronary angiography was also similar in both groups. The in-hospital mortality rate was similar in both the COVID-19 era and the control period groups (2.3% vs. 4.7%, respectively, P = 0.149) as was the 30-day mortality rate (3.7% vs. 5.1%, respectively, P = 0.238). CONCLUSION: In contrast to previous reports, admission rates of NSTEMI were similar in this nationwide survey during the COVID-19 era. With longer time from symptoms to admission, but with the same time from hospital admission to reperfusion therapy and with similar in-hospital and 30-day mortality rates. Even in times of crisis, adherence of medical systems to clinical practice guidelines ensures the preservation of good clinical outcomes.

Echocardiographic Ventricular Septal Motion Abnormalities Are Associated With Pre-Capillary Pulmonary Hypertension in Patients With Preserved Left Ventricular Function.

BACKGROUND: Ventricular septal motion abnormalities (VSMA) are common echocardiographic finding in patients with pulmonary hypertension (PHTN). This study sought to evaluate the relationship between echocardiographic findings and the classification of PHTN. METHODS: This study retrospectively studied 146 consecutive patients referred for right heart catheterisation for clinically suspected PHTN. VSMA were defined as any echocardiographic description of leftward abnormal septal motion or position. RESULTS: VSMA were present in 42 patients (29%). Patients with VSMA were younger and more likely to have prior pulmonary embolism. They also had less obstructive sleep apnoea, hypertension and dyslipidaemia. By echocardiography, patients with VSMA had lower left ventricular mass, left atrial size and lateral wall E/e' ratio. At cardiac catheterisation, PHTN was confirmed in all (100%) patients with VSMA (compared with 75% in patients without VSMA); 98% with VSMA had elevated pulmonary vascular resistance (compared with 55% without VSMA; p<0.005 for all). VSMA were found to have 91% sensitivity and 51% specificity for the diagnosis of pre-capillary PHTN. On multivariate analysis, VSMA were found to be strong independent predictors for the diagnosis of pre-capillary PHTN (HR, 9.15; 95% CI, 3.0-28.2; p<0.001). Left atrial enlargement was also a strong negative predictor for pre-capillary PHTN (HR, 0.14; 95% CI, 0.05-0.36; p<0.001). CONCLUSION: Ventricular septal motion abnormalities were strongly associated with pre-capillary PHTN in patients with suspected PHTN. The findings suggest that patients with VSMA should be further evaluated by right heart catheterisation.

Comparison of permanent pacemaker implantation rate after first and second generation of transcatheter aortic valve implantation-A retrospective cohort study.

OBJECTIVES: This study aimed to compare permanent pacemaker implantation (PPMI) rates among patients undergoing Trans-catheter Aortic Valve Implantation (TAVI) with first generation (G1) versus second generation (G2) valves and the impact of PPMI on long-term mortality. BACKGROUND: PPMI is a known adverse event after TAVI. Recently, two novel iterations of valve designs of both the balloon expandable valves (BEV) and self-expanding valves (SEV) were introduced as a second generation valves. METHODS: All patients included in the Israeli multicenter TAVI registry were grouped according to valve type (BEV vs. SEV) and generation (G1 vs. G2). A comparison was made for clinical and outcome indices of patients undergoing TAVI with G1 and G2 in each of the valve systems. RESULTS: A total of 1377 patients were included. The incidence of PPMI did not differ between G1-BEV versus G2-BEV (15.3% vs. 17.4%; p = 0.598) nor between G1-SEV versus G2-SEV (23.4% vs. 20.3%; p = 0.302). Depth of implantation and complete right bundle branch block were independently associated with PPMI post-TAVI in both valve systems. PPMI was not associated with an increased risk for 2-year mortality. CONCLUSIONS: The incidence of PPMI remains a relevant adverse event post-TAVI even when the newer generation valves are used. Since the predictors for PPMI are well established, a standardized approach for the management of conduction disorders is much needed.

Prognostic implication of right ventricular dysfunction and tricuspid regurgitation following transcatheter aortic valve replacement.

OBJECTIVES: Right ventricular (RV) dysfunction and tricuspid regurgitation (TR) are associated with adverse outcomes in severe aortic stenosis (AS) patients. Our aim was to evaluate the association between ≥moderate TR and RV dysfunction on long-term mortality following transcatheter aortic valve replacement (TAVR). METHODS: A retrospective analysis of the Israeli multicenter TAVR registry among 4,344 consecutive patients, with all-cause mortality as the main outcome measure. RESULTS: Echocardiographic assessment of TR grade and RV dysfunction was available for 3,733 and 1,850 patients, of whom ≥moderate TR and RV dysfunction was noted for 478(13%) and 78(4%), respectively. The mean follow-up time was 2.9 ± 2.3 years. In univariate models, ≥Moderate TR and ≥moderate RV dysfunction were associated with increased long-term mortality (HR 1.45, 95% CI 1.24-1.69, p < .001 and HR 1.73, 95% CI 1.21-2.47, p = 0.003, respectively). These finding did not remained significant after adjusting to echocardiographic parameters. A subset of patients with no improvement in RV function had the highest long-term mortality risk (HR 3.3, 95% CI 1.95-5.7, p < .001). CONCLUSION: When adjusted to multiple echocardiographic characteristics baseline ≥Moderate TR and ≥moderate RV dysfunction were not associated with long-term mortality following TAVR. Persistent RV dysfunction following TAVR was associated with the highest risk for mortality.

Impact of preprocedural left ventricle hypertrophy and geometrical patterns on mortality following TAVR.

BACKGROUND: In contrast to surgical aortic valve replacement, left ventricle (LV) hypertrophy (LVH) had not been clearly associated with mortality following transcatheter aortic valve replacement (TAVR). METHODS: We performed a retrospective analysis of patients enrolled in the Israeli multicenter TAVR registry for whom preprocedural LV mass index (LVMI) data were available. Patients were divided into categories according to LVMI: normal LVMI and mild, moderate, and severe LVH. Mild LVH was regarded as the reference group. Additionally, LV geometry patterns were examined (concentric and eccentric LVH, and concentric remodeling). RESULTS: The cohort consisted of 1,559 patients, 46.5% male, with a mean age of 82.2 (±6.8) years and mean LVMI of 121 (±29) g/m2. Rates of normal LVMI and mild, moderate, and severe LVH were 31% (n = 485), 21% (n = 322), 18% (n = 279), and 30% (n = 475), respectively. Three-year mortality rates for normal LVMI and mild, moderate, and severe LVH were 19.8%, 18.3%, 23.7%, and 24.4%, respectively. Compared to mild LVH, moderate LVH and severe LVH were independently associated with an increased risk for all-cause mortality (hazard ratio [HR] 1.58, 95% CI 1.15-2.18, P = .005; HR 1.46, 95% CI 1.1-1.95, P = .009; respectively). Concentric LVH was independently associated with a decreased risk for mortality compared to normal LV geometry (HR 0.75, 95% CI 0.63-0.89, P = .001). Compared to concentric LVH, eccentric LVH was independently associated with a 33% increased risk for mortality (HR 1.33, 95% CI 1.11-1.60, P = .002). CONCLUSIONS: Mild concentric LVH confers a protective effect among patients with severe aortic stenosis undergoing TAVR. However, hypertrophy becomes maladaptive, and an increased baseline LVMI, eccentric pattern particularly, may be associated with all-cause mortality in this population.

Percutaneous nitinol-based vascular closure device for large bore arterial access hemostasis: Results of a prospective multicenter study.

BACKGROUND: Vascular complications during transcatheter aortic valve replacement (TAVR) still pose a significant concern regarding procedural safety. Designated closure devices for large-bore vascular access are needed. METHODS: Patients undergoing TAVR were prospectively enrolled into the study. The InSeal vascular closure device (VCD) achieves hemostasis by utilizing a crescent-shaped nitinol scaffold covered by a biodegradable membrane, which is delivered at the arterial puncture site. The coprimary endpoints were predefined as hemostasis within 15 min following vessel access site closure and after activated clotting time falls below 200 s and the rate of related major vascular adverse events in first month. RESULTS: A total of 50 patients were prospectively enrolled into the study, with an average age of 80.8 ± 7.4 years and 62% males. Hemostasis with the Inseal VCD was achieved in 94% of the patients with average time-to-hemostasis of 51 ± 97 s. The rates of in-hospital vascular complications were 12% mostly driven by minor vascular complications (10%). Femoral artery stents were used in three patients due to failed hemostasis. CONCLUSIONS: Initial clinical experience indicates that a novel, nitinol-based, large-bore vascular closure device is safe and effective in achieving hemostasis after TAVR.

Predicting the risk of late futile outcome after transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) for aortic stenosis (AS) risk assessment is still developing and mostly concerned with mortality in the periprocedural period. We therefore sought to develop and then validate a score to predict 1-year adverse outcome. METHODS: Patients that underwent TAVI for severe AS in the Israeli registry. Patients with unsuccessful/suboptimal implantation were excluded. The cohort was split to derivation/validation cohorts by a ratio of 70:30. The outcome was defined as 1-year composite of mortality, stroke, and no improvement in NYHA class (vs. baseline). Logistic regression was used to fit the prediction model. RESULTS: Out of 2,440 patients meeting inclusion criteria, 276 were excluded, leaving 2,160 patients for both cohorts. At 1 year, 299 (14%) patients experienced the adverse ("futile") outcome. The derived prediction model included mean aortic valve (AV) gradient, previous pacemaker, previous oncological disease, need for diuretics, baseline NYHA class, hemoglobin and creatinine levels, and nonfemoral access site. The model's area under the curve (AUC) was 0.69 in the derivation and 0.70 in the validation cohort. Performance of other scores in the validation cohort were lower (0.60 for STS, 0.55 for Euroscore2, 0.56 for TVT score, and 0.53 for TAVI2-score, p = .03). Based on three risk tiers, patients had a low risk (20/306, 7% futility), a medium risk (50/304, 17%), and high risk (18/37, 49%) for futility. CONCLUSIONS: The TAVI futility risk model can be used to provide further insight regarding prediction measures and/or patients' outcomes outside of the periprocedural period (NCT02023060).

Balloon Pulmonary Angioplasty for Inoperable Chronic Thromboembolic Pulmonary Hypertension: First Experience at the Israeli National CTEPH Referral Center.

BACKGROUND: Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare, distinct pulmonary vascular disease caused by chronic obstruction of major pulmonary arteries, which can be cured by pulmonary endarterectomy. However, many CTEPH patients are not surgical candidates. Balloon pulmonary angioplasty (BPA) is an emerging technique used to treat inoperable CTEPH. OBJECTIVES: To describe the first Israeli experience with BPA for inoperable CTEPH. METHODS: In 2017 we established a BPA program at our institution. We reviewed the outcomes to date of BPA in our center. RESULTS: Forty-seven BPA procedures were performed in five patients with inoperable CTEPH (4-17 procedures/patient). Mean pulmonary artery pressure improved in all patients (median decrease 17 mmHg, range 10-26 mmHg). Pulmonary vascular resistance also improved (median decrease 11 Woods Units/m2, range 8-16 Woods Units/m2). Cardiac output increased in 4 of 5 patients and decreased in one. Functional capacity improved from New York Heart Association (NYHA) III to II in four patients; one patient was NYHA II at baseline without change after BPA. Six-minute walking distance improved by a median of 97 meters. (range 21-197 meters). Hemodynamic and functional improvements were sustained at follow-up 5-11 months after the last BPA procedure. BPA enabled 2 of 3 patients treated with parenteral prostanoids to be switched to oral therapy. There were no major complications. CONCLUSIONS: We successfully established BPA as a treatment for inoperable CTEPH in our center. BPA resulted in hemodynamic and clinical improvements that were sustained over time.

Relation of Age to Risk of Major Rejections, Allograft Vasculopathy, and Long-Term Mortality in a Contemporary Cohort of Patients Undergoing Heart Transplantation.

OBJECTIVES: To investigate the impact of recipient age on the occurrence of rejections, vasculopathy, and mortality after HTx. METHODS: Study population comprised all consecutive 291 patients who underwent HTx between 1991-2016 and were followed at our center. Patients were categorized by age tertiles: < 46 years (mean 31.4 ± 11.7, range 16-45, n=90), 46-57 years (mean 51.4 ± 3.2, range 46-56, n=92), and ≥ 57 years (mean 61.6 ± 3.4, range 57-73, n=109). RESULTS: Patients aged ≥ 57 years were more often males and had more pre-HTx co-morbidities including hypertension, diabetes, dyslipidemia, and history of smoking (P < 0.05) compared to the younger age groups. Kaplan-Meier analysis by age tertiles showed the rates of major rejections and vasculopathy at 15 years were similar among the three age groups. Mortality rates at 15 years were directly related to the age groups (39%, 52%, 62% log-rank, P = 0.01). However, the association between age and mortality was no longer statistically significant after multivariate analysis (hazard ratio 1.01, 95% confidence interval 1.00-1.03). CONCLUSIONS: In a contemporary cohort of patients undergoing HTx, recipient age does not significantly impact the risk of major rejections, vasculopathy, and long-term mortality.

The effect of periprocedural beta blocker withdrawal on arrhythmic risk following transcatheter aortic valve replacement.

OBJECTIVE: To evaluate the efficacy and safety of periprocedural beta-blocker (BB) discontinuation among patients undergoing transcatheter aortic valve replacement (TAVR) and high degree atrioventricular block (HD-AVB) and/or atrial fibrillation (AF). METHODS: The study population comprised 743 consecutive patients who underwent TAVR between 2009 and 2017 in two high-volume tertiary centers. All patients received chronic BB therapy, and were divided into two groups: (1) BB continuation and (2) BB discontinued 24 hr prior to the procedure. The primary endpoint was the development of composite brady and tachy-arrhytmic events (including HD-AVB and/or NOAF) following the procedure. RESULTS: Among 743 study patients, 366 (49%) continued BB prior to the procedure and in 377 (51%) chronic BB therapy was discontinued. The rate of the composite periprocedural arrhythmic event was significantly higher among patients who stopped BB (20% vs. 13%, respectively, P = 0.018). Consistently, multivariate analysis showed that discontinuation of BB was associated with two-fold (P = 0.003) increase in the risk for periprocedural arrhythmic events (OR = 2.0; 95% CI 1.24-3.23; P = 0.004). The association between BB discontinuation and periprocedural arrhythmic events was consistent for the separate endpoints for HDAV and NOAF. Furthermore, the need for permanent pacemaker was significantly higher among patients who discontinued BB (20% vs. 13%; P = 0.018, respectively). CONCLUSIONS: Among patients undergoing TAVR who receive chronic BB therapy, BB discontinuation prior to the procedure is independently associated with a significant increase in the rate of adverse arrhythmic events, including HDAVB, NOAF, and the need for pacemaker implantation.

Safety outcomes of new versus old generation transcatheter aortic valves.

OBJECTIVE: To compare procedural outcomes of transcatheter aortic valve implantation (TAVI) patients who were implanted with older versus newer generation valves. BACKGROUND: The current evidence base for improved safety of the newer commercially available TAVI valves is limited. METHODS: A retrospective analysis of the Israeli multicenter TAVI registry was performed. Patients were stratified by valve generation of four commercially available devices: Edwards Sapien (ESX) Edwards Sapien S3 (ES3), Medtronic CoreValve (MCV), and Medtronic Evolut R (MER). RESULTS: The cohort consisted of 737 patients with new generation valves (NGVs; ES3 n = 223; MER n = 514) and 1,869 with old generation valves (OGVs; MCV n = 1,181; ESX n = 688). Device success rates were significantly higher in NGV (97.5 versus 95.4%), with less post-procedural paravalvular leak (3 versus 5.8%), and valve mal-positioning (1.2 versus 3.4%); all P-values<0.05. There were no differences in rates of permanent pacemaker implantation, stroke or acute kidney injury (AKI) of any stage between the groups, although stage ≥2 AKI was more prevalent in NGV. After adjustment to significant differences in baseline patient and procedural characteristics, device success was higher (OR 1.86, 95% confidence interval (CI) 1.09-3.18, P = 0.023) and the 1-month safety outcome was significantly lower (OR 0.72, 95% CI 0.55-0.96, P = 0.025) for NGV. Device success was driven mainly by improved rates of PVL of ES3, while the safety outcome was mainly driven by improved rates of life-threatening bleeding and valve mal-positioning of MER. CONCLUSION: As compared to OGV, use of NGV for TAVI was associated with higher rates of device success and lower rates of adverse events.

Long-Term Outcomes of Iliofemoral Artery Stents after Transfemoral Aortic Valve Replacement.

PURPOSE: To report long-term results of iliofemoral stent placement after transcatheter aortic valve replacement (TAVR). MATERIALS AND METHODS: TAVR access-related complications treated with iliofemoral stent placement were recorded in 56 patients (mean age, 81 years; range; 53-93 years; 48% male) of 648 patients who underwent TAVR at a single center. Fifty-six patients treated with stent placement (40 patients with stent grafts and 16 patients with bare metal stents) underwent clinical and ultrasonographic follow-up after a mean of 676 days (range, 60-1840 days). RESULTS: During follow-up, none of the 56 patients who had stent placement underwent a vascular reintervention of the affected limb, and none suffered from limb claudication. No decrease was observed in ankle-brachial index (ABI) values to an abnormal value, except in 1 patient (mean preprocedural and postprocedural ABI of 1.2 ± 0.14, range, 0.97-1.4 and 1.19 ± 0.24, range, 0.65-1.54, respectively). Arterial duplex assessment showed normal stent flow velocity (mean, 168.7 ± 63.2 cm/sec; range, 80-345 cm/sec) in all but 1 patient. CONCLUSION: Iliofemoral stent implantation is a safe and efficacious treatment for vascular access site and access-related complications during transfemoral TAVR.

Exercise Hemodynamics for the Diagnosis of Diastolic Dysfunction in Dyspneic Patients with Systemic Sclerosis.

OBJECTIVES: To assess the added diagnostic value of using exercise hemodynamics during RHC in assessment of patients with symptomatic SSc. METHODS: We performed 22 RHCs in 17 SSc patients with dyspnea and/or pulmonary arterial hypertension (PAH). Exercise was performed in 15 RHCs using isotonic arm exercises while holding a 1 kg weight in each hand. Measurements of pulmonary arterial pressure (PAP), pulmonary arterial wedge pressure (PAWP), and cardiac output (CO) were taken at rest and during peak exercise. RESULTS: Normal resting RHC (PAP 22  3 mmHg, PAWP 11  3 mmHg) was found in seven cases. Of these, exercise induced elevation in PAP was found in three (38  7 mmHg), and exercise induced elevation in PAWP was found in four (24  6 mmHg). Elevated resting PAP was found in 15 (41  11 mmHg) with minor changes in exercise. Of the 22 RHCs, elevation of the PAWP was found in 11 (50%), half of which were in response to exercise. CONCLUSIONS: In symptomatic SSc patients, exercise hemodynamics provides important information on diastolic dysfunction that is not available with non-invasive testing. Findings on exercise RHC can explain patient symptoms in up to 50% of cases. Earlier and more accurate diagnosis of patient symptoms can aid in tailoring the correct therapy for each.

Prognostic significance of aortic valve gradient in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement.

OBJECTIVE: To evaluate the effect of baseline aortic valve gradient (AVG) both as a continuous and a categorical variable on mortality in patients undergoing transcatheter aortic valve replacement (TAVR), focusing on the high-gradient severe aortic stenosis (AS) patients. BACKGROUND: Identifying new predictors of mortality in the TAVR population can help refine risk stratification and improve the patient selection process for this procedure. So far, AVG has mainly been studied as a categorical variable and there is a paucity of data on its prognostic value as a continuous variable, especially in patients with high AVG AS, who constitute the majority of patients referred for TAVR. METHODS: We analyzed data on 1,224 consecutive symptomatic severe AS patients, who underwent TAVR at 3 centers. The relation between pre-TAVR AVG and mortality was evaluated among all patients and in patients with high AVGs (mean AVG ≥40 mm Hg) using the Cox proportional hazard model adjusting for multiple variables. RESULTS: During a mean follow-up of 1.8 years, baseline AVG was inversely associated with mortality in the entire cohort and in patients with high AVG AS. By multivariable analysis, patients with mean AVG 40-60 mm Hg and >60 mm Hg had a respective 38% (P = 0.010) and 61% (P < 0.001) reduction in mortality compared to patients with mean AVG <40 mm Hg. Every 10 mm Hg increase in mean AVG was associated with 20% reduction in mortality (P < 0.001). Analyses among patients with high (mean AVG >40 mm Hg) and very high AVG AS (mean AVG >60 mm Hg) yielded similar results (HR = 0.88, P = 0.031, and HR = 0.80, P = 0.019, per 10 mm Hg increase in AVG, respectively). Using peak AVGs and an analysis restricted to patients without reduced ejection fraction yielded consistent results. CONCLUSIONS: Baseline AVGs show an inverse association with mortality post-TAVR. These results were consistent also in patients with high-gradient AS, suggesting that AVG can be used to identify patients most likely to benefit from TAVR.