Ignacio Inglessis

Outcomes of Transcatheter and Surgical Aortic Valve Replacement in High-Risk Patients With Aortic Stenosis and Left Ventricular Dysfunction Results From the Placement of Aortic Transcatheter Valves (PARTNER) Trial (Cohort A)

Background—The Placement of Aortic Transcatheter Valves (PARTNER) trial demonstrated similar survival after transcatheter and surgical aortic valve replacement (TAVR and SAVR, respectively) in high-risk patients with symptomatic, severe aortic stenosis. The aim of this study was to evaluate the effect of left ventricular (LV) dysfunction on clinical outcomes after TAVR and SAVR and the impact of aortic valve replacement technique on LV function. Methods and Results—The PARTNER trial randomized high-risk patients with severe aortic stenosis to TAVR or SAVR. Patients were stratified by the presence of LV ejection fraction (LVEF) <50%. All-cause mortality was similar for TAVR and SAVR at 30-days and 1 year regardless of baseline LV function and valve replacement technique. In patients with LV dysfunction, mean LVEF increased from 35.7±8.5% to 48.6±11.3% (P<0.0001) 1 year after TAVR and from 38.0±8.0% to 50.1±10.8% after SAVR (P<0.0001). Higher baseline LVEF (odds ratio, 0.90 [95% confidence interval, 0.86, 0.95]; P<0.0001) and previous permanent pacemaker (odds ratio, 0.34 [95% confidence interval, 0.15, 0.81]) were independently associated with reduced likelihood of ≥10% absolute LVEF improvement by 30 days; higher mean aortic valve gradient was associated with increased odds of LVEF improvement (odds ratio, 1.04 per 1 mm Hg [95% confidence interval, 1.01, 1.08]). Failure to improve LVEF by 30 days was associated with adverse 1-year outcomes after TAVR but not SAVR. Conclusions—In high-risk patients with severe aortic stenosis and LV dysfunction, mortality rates and LV functional recovery were comparable between valve replacement techniques. TAVR is a feasible alternative for patients with symptomatic severe aortic stenosis and LV dysfunction who are at high risk for SAVR. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

Impact of rapid ventricular pacing during percutaneous balloon aortic valvuloplasty in patients with critical aortic stenosis: Should we be using it?

Background: Rapid ventricular pacing (RP) during percutaneous balloon aortic valvuloplasty (BAV) facilitates balloon positioning by preventing the “watermelon seeding” effect during balloon inflation. The clinical consequences of RP BAV have never been compared with standard BAV in which rapid pacing in not used. We evaluated the immediate results and in‐hospital adverse events of patients with severe aortic stenosis (AS) undergoing BAV with and without RP. Methods: This is a retrospective study of patients with severe AS undergoing retrograde BAV. Patients who underwent BAV with RP were compared to those who did not receive RP during BAV. Procedural outcomes, complications, and in‐hospital adverse events were compared between both groups. Stratified analyses were performed to evaluate RP in pre‐specified subsets for confounding and effect modification. Results: Between January 2005 and December 2008, 111 consecutive patients underwent retrograde BAV at Massachusetts General Hospital. Sixty‐seven patients underwent BAV with RP. Nearly 90% of patients were NYHA class III or IV and the mean AVA was 0.64 cm2. Baseline characteristics and balloon sizes were similar in the two groups. The average post‐BAV AVA was smaller in the RP group compared to the no‐RP group (0.87 v. 1.02 cm2, p = 0.02). Pre and post‐cardiac output, in‐hospital mortality, myocardial infarction, stroke, frequency of cardiopulmonary arrest, vasopressor use, and major complications were similar in the two groups. Conclusions: 1) RP allows precise balloon placement during BAV. 2) RP BAV is associated with lower post‐BAV AVA. 3) RP BAV may be safely performed in patients with high‐risk cardiac features.

May-Thurner Syndrome in Patients With Cryptogenic Stroke and Patent Foramen Ovale An Important Clinical Association

Background and Purpose— We aimed to investigate the incidence of May-Thurner syndrome in patients with cryptogenic stroke with patent foramen ovale. Methods— This was a retrospective study. All consecutive patients with cryptogenic stroke having undergone patent foramen ovale closure from January 1, 2002, to December 31, 2007, at our institute were included in this study. Pelvic magnetic resonance venography studies of all patients were reviewed to determine if features of May-Thurner syndrome were present. Medical records and invasive venography studies of all patients were reviewed when available. All patients with May-Thurner syndrome features on magnetic resonance venography were reviewed by a vascular medicine specialist to define any previous incidence of deep vein thrombosis or any signs of chronic venous insufficiency. All patients also had lower limb venous duplex performed to rule out lower limb venous thrombosis. Results— A total of 470 patients from January 1, 2002, until December 31, 2007, with cryptogenic stroke underwent patent foramen ovale closure at our institute. Thirty patients (6.3%) had features consistent with May-Thurner syndrome on magnetic resonance venography. These patients were predominantly female (80%) with a mean age of 43.6±11.9 years. Twelve patients (40%) had abnormalities in their laboratory thrombophilia evaluation and 13 females (54.1%) were taking hormone-related birth control pills. Only 2 patients had a history and signs of chronic venous insufficiency. All patent foramen ovales demonstrated right-to-left shunting on transesophageal echocardiography. Atrial septal aneurysms/hypermobile atrial septa were present in 70% of patients with May-Thurner syndrome. Conclusion— May-Thurner syndrome has an important clinical association with cryptogenic stroke and patent foramen ovale.

Impact of Atrial Fibrillation on Outcomes in Patients Who Underwent Transcatheter Aortic Valve Replacement

Transcatheter aortic valve replacement (TAVR) has emerged as an alternative treatment for surgical high-risk patients with severe aortic stenosis. The aim of this study was to determine the impact of atrial fibrillation (AF) on procedural outcomes. Data from 137 patients who underwent TAVR using Edwards SAPIEN valve were reviewed. The predictors of new-onset atrial fibrillation (NOAF) after the procedure were analyzed. In addition, the post-TAVR clinical outcomes and adverse events were compared according to the presence and absence of preprocedural and postprocedural AF. Previous AF was present in 49% of the patients who underwent TAVR. After the procedure, NOAF was detected in 21% of patients, and the cumulative incidence of post-TAVR AF was 60%. After TAVR, 50% of all the episodes of NOAF occurred in the initial 24 hours after the procedure. Transapical approach was observed to an important predictor of NOAF (adjusted odds ratio [OR] 5.05, 95% confidence interval [CI] 1.40 to 18.20, p = 0.013). The composite outcome of all-cause mortality, stroke, vascular complications, and repeat hospitalization in 1 month after TAVR was significantly higher in patients with previous AF (33 of 67 vs 19 of 70, adjusted OR 2.60, 95% CI 1.22 to 5.54, p = 0.013) compared with patients who did not have previous AF. The presence of post-TAVR AF led to a prolongation in the duration of intensive care unit stay by an average of 70 hours (95% CI 25 to 114.7 hours, p = 0.002). Similarly, post-TAVR AF also led to the prolongation in the hospital stay by an average of 6.7 days (95% CI 4.69 to 8.73 days, p <0.0005). In conclusion, our study demonstrates that the presence of AF before TAVR is an important predictor of the composite end point of all-cause mortality, stroke, vascular complications, and repeat hospitalization in 1 month after the procedure. AF after TAVR is more likely to be encountered with the transapical approach and is associated with a prolongation of intensive care unit and hospital stay.

Retrograde versus antegrade percutaneous aortic balloon valvuloplasty: Immediate, short- and long-term outcome at 2 years†

The short‐ and long‐term vascular risks and hemodynamic benefits of antegrade versus retrograde percutaneous aortic balloon valvuloplasty (PAV) have not been clearly established. With the advent of percutaneous aortic valve replacement strategies, more valvuloplasties are being performed. The antegrade approach may reduce vascular complications, particularly in patients with peripheral vascular disease (PVD). Comparing the clinical efficacy and complications of each technique is warranted.

Comparison of Procedural and In-Hospital Outcomes of Percutaneous Balloon Aortic Valvuloplasty in Patients >80 Years Versus Patients <80 Years

Percutaneous balloon aortic valvuloplasty (PBAV) is a procedure used for palliation, bridging to surgery, and as an integral step in the procedure for percutaneous aortic valve replacement. Older patients with severe aortic stenosis are thought to have greater risk for adverse perioperative events than younger patients. The aim of this study was to evaluate the outcomes of patients aged >80 years and those aged < or =80 years who underwent PBAV to identify factors associated with adverse clinical outcomes. This was a retrospective study of 111 consecutive patients with severe symptomatic aortic stenosis who underwent retrograde PBAV at Massachusetts General Hospital from December 2004 to December 2008. Forty-nine patients (44%) were men, and the mean age for the whole group was 82 +/- 8 years. Patients were divided into 2 age groups: those aged >80 years (n = 73) and those aged < or =80 years (n = 38). Procedural outcomes, complications, and in-hospital adverse events were compared. Multivariate logistic regression was used for the adjusted analysis. Nearly 90% of patients were in New York Heart Association class III or IV. Patients aged >80 years had lower baseline ejection fractions (43.5% vs 56.1%, p <0.01) and smaller aortic valve areas (0.59 vs 0.73 cm(2), p <0.01). Although the 2 age groups had a similar percentage of aortic valve area increase (55.5% vs 45.2%, p = 0.28), those aged >80 years had smaller post-PBAV aortic valve areas (0.89 vs 1.02 cm(2), p <0.05). Overall, in-hospital mortality was 8.1%, with no significant differences between the groups. Advanced age was not an independent predictor of in-hospital death, myocardial infarction, stroke, cardiac arrest, or tamponade; however, patients aged >80 years had a significantly higher incidence of intraprocedural emergent intubation and cardiopulmonary resuscitation compared to the younger group. New York Heart Association class was the only independent predictor of worse in-hospital outcomes. In conclusion, compared to younger patients, those aged >80 years had less favorable preprocedural characteristics for PBAV but similar overall in-hospital clinical outcomes. Patients aged >80 years had significantly higher incidence of emergent intubation and cardiopulmonary resuscitation during PBAV.

Mitral balloon valvotomy for patients with mitral stenosis in atrial fibrillation: Immediate and long-term results

OBJECTIVES The purpose of this study was to examine the effect of atrial fibrillation (AF) on the immediate and long-term outcome of patients undergoing percutaneous mitral balloon valvuloplasty (PMV). BACKGROUND There is controversy as to whether the presence of AF has a direct negative effect on the outcome after PMV. METHODS The immediate procedural and the long-term clinical outcome after PMV of 355 patients with AF were prospectively collected and compared with those of 379 patients in normal sinus rhythm (NSR). RESULTS Patients with AF were older (62 +/- 12 vs. 48 +/- 14 years; p < 0.0001) and presented more frequently with New York Heart Association (NYHA) class IV (18.3% vs. 7.9%; p < 0.0001), echocardiographic score >8 (40.1% vs. 25.1%; p < 0.0001), calcified valves under fluoroscopy (32.4% vs. 18.8%, p < 0.0001) and with history of previous surgical commissurotomy (21.7% vs. 16.4%; p = 0.0002). In patients with AF, PMV resulted in inferior immediate and long-term outcomes, as reflected in a smaller post-PMV mitral valve area (1.7 +/- 0.7 vs. 2 +/- 0.7 cm2; p < 0.0001) and a lower event free survival (freedom of death, redo-PMV and mitral valve surgery) at a mean follow-up time of 60 months (32% vs. 61%; p < 0.0001). In the group of patients in AF, severe post-PMV mitral regurgitation (> or =3+) (p = 0.0001), echocardiographic score >8 (p = 0.004) and pre-PMV NYHA class IV (p = 0.046) were identified as independent predictors of combined events at follow-up. CONCLUSIONS Patients with AF have a worse immediate and long-term outcomes after PMV. However, the presence of AF by itself does not unfavorably influence the outcome, but is a marker for clinical and morphologic features associated with inferior results after PMV.

Management of residual shunts after initial percutaneous patent foramen ovale closure: a single center experience with immediate and long-term follow-up.

Background: Moderate‐to‐large residual shunts following percutaneous patent foramen ovale (PFO) closure are clinically important and associated with recurrent neuroembolic events. However, their management has not been clearly established in clinical practice. We report our experience in patients of these patients with a prior history of cryptogenic stroke and/or transient ischemic attack (TIA). Methods: All patients undergoing percutaneous PFO closure were routinely screened at six‐months for residual shunts using transthoracic 2D echocardiography with antecubital administration of agitated saline contrast and color flow Doppler. Patients with evidence of moderate‐to‐large residual shunts were selected to undergo reintervention with shunt closure. Postreintervention follow‐up was performed at 24‐hr, 30 days, and every six months thereafter. Clinical predictors of the moderate‐to‐large residual shunts, and the feasibility, safety and long‐term efficacy of percutaneous residual shunt closure using a second device implant were examined. Results: Between 1995 and 2007, a total of 424 patients underwent PFO closure. Of these, 5% (21/424) had moderate‐to‐large residual shunts. Baseline characteristics among patients with moderate‐to‐large residual shunts and those with only none or small defects (n = 403) were similar. Multivariate analysis identified the 24‐hr postprocedure shunt as the only independent predictor of residual shunting at six months. Of the 21 study patients with moderate‐to‐large residual shunt (mean age, 47 ± 14), one underwent successful elective surgical repair, while the remaining 20 underwent transcatheter closure using a second device. The technique was successful in 95% (19/20), and all but one patient had complete shunt closure at six months of their percutaneous reintervention. We report no deaths, recurrent strokes or TIAs during the long‐term mean follow‐up period of 2.9 years. Conclusions: Our study suggests that in patients with moderate‐to‐large residual PFO shunts, percutaneous reintervention using a second device implant is safe and effective.

Transcatheter aortic valve replacement and standard therapy in inoperable patients with aortic stenosis and low EF

Objectives The aims of this study were to evaluate the effect of left ventricular (LV) dysfunction on clinical outcomes after transcatheter aortic valve replacement (TAVR) and standard therapy for severe aortic stenosis (AS) and to assess LV ejection fraction (LVEF) recovery and its impact on subsequent clinical outcomes. Methods Cohort B of the Placement of AoRtic TraNscathetER Valves trial randomised 342 inoperable patients with severe AS to TAVR or standard therapy. We defined LV dysfunction as an LVEF <50% and LVEF improvement as an absolute increase in LVEF ≥10% at 30 days. Results Baseline LV dysfunction did not affect survival after TAVR but was associated with increased cardiac mortality at 1 year with standard therapy (59.3% vs 45.8% with normal LVEF; HR=1.71 (95% CI 1.08 to 2.71); p=0.02). In those with LV dysfunction, LVEF improvement occurred in 48.7% and 30.4% of TAVR and standard therapy patients, respectively (p=0.08), and was independently predicted by relative wall thickness and receipt of TAVR. LVEF improvement with standard therapy portended reduced all-cause mortality at 1 year (28.6% vs 65.6% without LVEF improvement; HR=0.32 (95% CI 0.11 to 0.93); p=0.03) but not at 2 years. Conclusions In inoperable patients with severe AS, mild-to-moderate LV dysfunction is associated with higher cardiac mortality with standard therapy but not TAVR. A subset of patients undergoing standard therapy with LV dysfunction demonstrates LVEF improvement and favourable 1-year but not 2-year survival. TAVR improves survival and should be considered the standard of care for inoperable patients with AS and LVEF >20%. Trial registration number ClinicalTrials.gov Unique Identifier #NCT00530894.

The Echo Score Revisited: Impact of Incorporating Commissural Morphology and Leaflet Displacement to the Prediction of Outcome for Patients Undergoing Percutaneous Mitral Valvuloplasty

Background— Current echocardiographic scoring systems for percutaneous mitral valvuloplasty (PMV) have limitations. This study examined new, more quantitative methods for assessing valvular involvement and the combination of parameters that best predicts immediate and long-term outcome after PMV. Methods and Results— Two cohorts (derivation n=204 and validation n=121) of patients with symptomatic mitral stenosis undergoing PMV were studied. Mitral valve morphology was assessed by using both the conventional Wilkins qualitative parameters and novel quantitative parameters, including the ratio between the commissural areas and the maximal excursion of the leaflets from the annulus in diastole. Independent predictors of outcome were assigned a points value proportional to their regression coefficients: mitral valve area ⩽1 cm2 (2), maximum leaflets displacement ⩽12 mm (3), commissural area ratio ≥1.25 (3), and subvalvular involvement (3). Three risk groups were defined: low (score of 0–3), intermediate (score of 5), and high (score of 6–11) with observed suboptimal PMV results of 16.9%, 56.3%, and 73.8%, respectively. The use of the same scoring system in the validation cohort yielded suboptimal PMV results of 11.8%, 72.7%, and 87.5% in the low-, intermediate-, and high-risk groups, respectively. The model improved risk classification in comparison with the Wilkins score (net reclassification improvement 45.2%; P<0.0001). Long-term outcome was predicted by age and postprocedural variables, including mitral regurgitation, mean gradient, and pulmonary pressure. Conclusions— A scoring system incorporating new quantitative echocardiographic parameters more accurately predicts outcome following PMV than existing models. Long-term post-PMV event-free survival was predicted by age, degree of mitral regurgitation, and postprocedural hemodynamic data.