Melanie Freeman

3-dimensional aortic annular assessment by multidetector computed tomography predicts moderate or severe paravalvular regurgitation after transcatheter aortic valve replacement: a multicenter retrospective analysis.

OBJECTIVESnThis study sought to analyze multidetector computed tomography (MDCT) 3-dimensional aortic annular dimensions for the prediction of paravalvular aortic regurgitation (PAR) following transcatheter aortic valve replacement (TAVR).nnnBACKGROUNDnModerate or severe PAR after TAVR is associated with increased morbidity and mortality.nnnMETHODSnA total of 109 consecutive patients underwent MDCT pre-TAVR with a balloon expandable aortic valve. Differences between transcatheter heart valve (THV) size and MDCT measures of annular size (mean diameter, area, and circumference) were analyzed concerning prediction of PAR. Patients with THV malposition (n = 7) were excluded. In 50 patients, MDCT was repeated after TAVR to assess THV eccentricity (1 - short diameter/long diameter) and expansion (MDCT measured THV area/nominal THV area).nnnRESULTSnModerate or severe PAR (13 of 102) was associated with THV undersizing (THV diameter - mean diameter = -0.7 ± 1.4 mm vs. 0.9 ± 1.8 mm for trivial to mild PAR, p < 0.01). The difference between THV size and MDCT annular size was predictive of PAR (mean diameter: area under the curve [AUC]: 0.81, 95% confidence interval [CI]: 0.68 to 0.88; area: AUC: 0.80, 95% CI: 0.65 to 0.90; circumference: AUC: 0.76, 95% CI: 0.59 to 0.91). Annular eccentricity was not associated with PAR (AUC: 0.58, 95% CI: 0.46 to 0.75). We found that 35.3% (36 of 102) and 45.1% (46 of 102) of THVs were undersized relative to the MDCT mean diameter and area, respectively. THV oversizing relative to the annular area was not associated with THV eccentricity or underexpansion (oversized vs. undersized THVs; expansion: 102.7 ± 5.3% vs. 106.1 ± 5.6%, p = 0.03; eccentricity: median: 1.7% [interquartile range: 1.4% to 3.0%] vs. 1.7% [interquartile range: 1.1% to 2.7%], p = 0.28).nnnCONCLUSIONSnMDCT-derived 3-dimensional aortic annular measurements are predictive of moderate or severe PAR following TAVR. Oversizing of THVs may reduce the risk of moderate or severe PAR.

The Impact of Integration of a Multidetector Computed Tomography Annulus Area Sizing Algorithm on Outcomes of Transcatheter Aortic Valve Replacement A Prospective, Multicenter, Controlled Trial

OBJECTIVESnThis study prospectively investigated the impact of integration of a multidetector computed tomography (MDCT) annular area sizing algorithm on transcatheter aortic valve replacement (TAVR) outcomes.nnnBACKGROUNDnAppreciation of the 3-dimensional, noncircular geometry of the aortic annulus is important for transcatheter heart valve (THV) sizing.nnnMETHODSnPatients being evaluated for TAVR in 4 centers underwent pre-procedural MDCT. Recommendations for balloon-expandable THV size selection were based on an MDCT sizing algorithm with an optimal goal of modest annulus area oversizing (5% to 10%). Consecutive patients who underwent TAVR with the algorithm (MDCT group) were compared with consecutive patients without the algorithm (control group). The primary endpoint was the incidence of more than mild paravalvular regurgitation (PAR), and the secondary endpoint was the composite of in-hospital death, aortic annulus rupture, and severe PAR.nnnRESULTSnOf 266 patients, 133 consecutive patients underwent TAVR (SAPIEN XT THV) in the MDCT group and 133 consecutive patients were in the control group. More than mild PAR was present in 5.3% (7 of 133) of the MDCT group and in 12.8% (17 of 133) in the control group (p = 0.032). The combined secondary endpoint occurred in 3.8% (5 of 133) of the MDCT group and in 11.3% (15 of 133) of the control group (p = 0.02), driven by the difference of severe PAR.nnnCONCLUSIONSnThe implementation of an MDCT annulus area sizing algorithm for TAVR reduces PAR. Three-dimensional aortic annular assessment and annular area sizing should be considered for TAVR.

5-Year Outcome After Transcatheter Aortic Valve Implantation

OBJECTIVESnThe purpose of this study was to investigate the 5-year outcome following transcatheter aortic valve implantation (TAVI).nnnBACKGROUNDnLittle is known about long-term outcomes following TAVI.nnnMETHODSnThe 5-year outcomes following successful TAVI with a balloon-expandable valve were evaluated in 88 patients. Patients who died within 30 days after TAVI were excluded.nnnRESULTSnMean aortic valve gradient decreased from 46 ± 18 mm Hg to 10 ± 4.5 mm Hg after TAVI and 11.8 ± 5.7 mm Hg at 5 years (p for post-TAVI trend = 0.06). Mean aortic valve area increased from 0.62 ± 0.17 cm(2) to 1.67 ± 0.41 cm(2) after TAVI and 1.40 ± 0.25 cm(2) at 5 years (p for post-TAVI trend <0.01). At 5 years, 3 patients (3.4%) had moderate prosthetic valve dysfunction (moderate transvalvular regurgitation in 1, moderate stenosis in 1, and moderate mixed disease in 1). Survival rates at 1 to 5 years were 83%, 74%, 53%, 42%, and 35%, respectively. Median survival time after TAVI was 3.4 years (95% confidence interval [CI]: 2.6 to 4.3), and the risk of death was significantly increased in patients with chronic obstructive pulmonary disease (adjusted hazard ratio [HR]: 2.17; 95% CI: 1.28 to 3.70) and at least moderate paravalvular regurgitation (adjusted HR: 2.98; 95% CI: 1.44 to 6.17).nnnCONCLUSIONSnOur study demonstrated favorable long-term outcomes after TAVI. Signs of moderate prosthetic valve failure were observed in 3.4% of patients. No patients developed severe prosthetic regurgitation or stenosis. Comorbidities, notably chronic lung disease and at least moderate paravalvular regurgitation, were associated with reduced long-term survival.

Percutaneous Left Atrial Appendage Closure With the AMPLATZER Cardiac Plug Device in Patients With Nonvalvular Atrial Fibrillation and Contraindications to Anticoagulation Therapy

OBJECTIVESnThe aim of this study was to evaluate the results associated with left atrial appendage closure (LAAC) with the AMPLATZER Cardiac Plug (ACP) (St. Jude Medical, Minneapolis, Minnesota) in patients with nonvalvular atrial fibrillation and absolute contraindications to anticoagulation therapy.nnnBACKGROUNDnFew data exist on the late outcomes after LAAC in patients with absolute contraindications to warfarin.nnnMETHODSnA total of 52 patients with nonvalvular atrial fibrillation underwent LAAC with the ACP device in 7 Canadian centers. Most patients received short-term (1 to 3 months) dual-antiplatelet therapy after the procedure and single-antiplatelet therapy thereafter. A transesophageal echocardiography was performed in 74% of patients at the 6-month follow-up. No patient was lost to follow-up (≥ 12 months in all patients).nnnRESULTSnThe mean age and median (interquartile range) CHADS2 score were 74 ± 8 years and 3 (2 to 4), respectively. The procedure was successful in 98.1% of the patients, and the main complications were device embolization (1.9%) and pericardial effusion (1.9%), with no cases of periprocedural stroke. At a mean follow-up of 20 ± 5 months, the rates of death, stroke, systemic embolism, pericardial effusion, and major bleeding were 5.8%, 1.9%, 0%, 1.9%, and 1.9%, respectively. The presence of mild peridevice leak was observed in 16.2% of patients at the 6-month follow-up as evaluated by transesophageal echocardiography. There were no cases of device thrombosis.nnnCONCLUSIONSnIn patients with nonvalvular atrial fibrillation at high risk of cardioembolic events and absolute contraindications to anticoagulation, LAAC using the ACP device followed by dual-/single-antiplatelet therapy was associated with a low rate of embolic and bleeding events after a mean follow-up of 20 months. No cases of severe residual leak or device thrombosis were observed at the 6-month follow-up.

Transcatheter aortic valve replacement with the SAPIEN 3: a new balloon-expandable transcatheter heart valve.

OBJECTIVESnThe aim of this study was to demonstrate the first-in-human feasibility and short-term clinical outcomes with a new balloon-expandable transcatheter heart valve (THV).nnnBACKGROUNDnThe SAPIEN 3 (S3) THV incorporates a paravalvular sealing system, an active 3-dimensional coaxial positioning catheter, and is compatible with a 14-F expandable sheath.nnnMETHODSnThe S3 THV was implanted in 15 patients with symptomatic severe aortic stenosis via femoral arterial access. Multidetector computed tomography before and after valve implantation allowed assessment of a novel annular area sizing algorithm. Clinical and echocardiographic data were obtained at baseline, discharge, and 30 days.nnnRESULTSnAll 15 device implants were successful. Multidetector computed tomography estimated an aortic annular area of 4.9 ± 0.4 cm(2), predicting 9.7 ± 6.9% THV oversizing. Post-transcatheter aortic valve replacement multidetector computed tomography showed consistently symmetrical and circular THVs. Aortic valve area increased from 0.7 ± 0.2 cm(2) to 1.5 ± 0.2 cm(2) (p < 0.001), and mean transaortic gradient decreased from 42.2 ± 10.3 mm Hg to 11.9 ± 5.3 mm Hg (p < 0.001). No patient had more than mild paravalvular aortic regurgitation. Hospital discharge occurred at a median of 3 (range 2 to 12) hospital days. At 30 days there were no deaths, strokes, vascular complications, bleeds, or transfusions, although 1 patient (6.7%) required a new pacemaker. All patients were in New York Heart Association functional class I or II.nnnCONCLUSIONSnThe S3 THV and delivery system might facilitate fully percutaneous implantation in a broader range of patients with the potential for more accurate positioning and less paravalvular regurgitation.

5-year experience with transcatheter transapical mitral valve-in-valve implantation for bioprosthetic valve dysfunction.

OBJECTIVESnThe study sought to describe the authors experience with mitral transapical transcatheter valve-in-valve implantation (TVIV).nnnBACKGROUNDnIncreasing numbers of mitral biological prostheses are being implanted in clinical practice. Transcatheter valve-in-valve implantation may be a lower risk alternative treatment for high-risk patients with mitral valve degeneration.nnnMETHODSnTwenty-three consecutive patients with severe mitral bioprosthetic valve dysfunction underwent transapical mitral TVIV between July 2007 and September 2012. Bioprosthetic failure was secondary to stenosis in 6 (26.1%), regurgitation in 9 (39.1%), and combined in 8 (34.8%) patients.nnnRESULTSnAll patients were elderly (mean age 81 ± 6 years) and at high-risk for conventional redo surgery (Society of Thoracic Surgeons score 12.1 ± 6.8%). Successful transapical mitral TVIV was accomplished in all patients using balloon expandable valves (Edwards Lifesciences, Irvine, California) with no intraoperative major complications. One (4.4%) major stroke and 6 (26.1%) major bleeds were reported during hospitalization. Mitral transvalvular gradient significantly decreased from 11.1 ± 4.6 mm Hg to 6.9 ± 2.2 mm Hg following the procedure (p < 0.01). Intervalvular mitral regurgitation was absent (47.8%) or mild (52.2%) in all cases after mitral TVIV. No cases of transvalvular regurgitation were seen. All patients were alive on 30-day follow-up. At a median follow-up of 753 days (interquartile range: 376 to 1,119 days) survival was 90.4%. One patient underwent successful mitral TVIV reintervention at 2 months due to atrial migration of the transcatheter valve. All patients alive were in New York Heart Association functional class I/II with good prosthetic valve performance.nnnCONCLUSIONSnTranscatheter transapical mitral valve-in-valve implantation for dysfunctional biological mitral prosthesis can be performed with minimal operative morbidity and mortality and favorable midterm clinical and hemodynamic outcomes.

Transcatheter Aortic Valve Replacement: Outcomes of Patients With Moderate or Severe Mitral Regurgitation

OBJECTIVESnThe aim of this study was to evaluate the impact of mitral regurgitation (MR) on outcomes after transcatheter aortic valve replacement (TAVR) and the impact of TAVR on MR.nnnBACKGROUNDnLittle is known of the influence of MR on outcomes after TAVR.nnnMETHODSnThe outcomes of patients with mild or less (n = 319), moderate (n = 89), and severe (n = 43) MR were evaluated after TAVR at 2 Canadian centers.nnnRESULTSnPatients with moderate or severe MR had a higher mortality rate than those with mild or less MR during the 30 days after TAVR (adjusted hazard ratio: 2.10; 95% confidence interval: 1.12 to 3.94; p = 0.02). However, the mortality rates after 30 days were similar (adjusted hazard ratio: 0.82; 95% confidence interval: 0.50 to 1.34; p = 0.42). One year after TAVR, moderate MR had improved in 58%, remained moderate in 17%, and worsened to severe in 1%, and 24% of patients had died. Severe MR had improved in 49% and remained severe in 16%, and 35% of patients had died. Multivariate predictors of improved MR at 1 year (vs. unchanged MR, worse MR, or death) were a mean transaortic gradient ≥ 40 mm Hg, functional (as opposed to structural) MR, the absence of pulmonary hypertension, and the absence of atrial fibrillation.nnnCONCLUSIONSnModerate or severe MR in patients undergoing TAVR is associated with a higher early, but not late, mortality rate. At 1-year follow-up, MR was improved in 55% of patients with moderate or severe MR at baseline. Improvement was more likely in patients with high transaortic gradients, with functional MR, without pulmonary hypertension and without atrial fibrillation.

Impact of Low Flow on the Outcome of High-Risk Patients Undergoing Transcatheter Aortic Valve Replacement

OBJECTIVESnThis study sought to assess the impact of baseline left ventricular (LV) outflow, LV ejection fraction (LVEF), and transvalvular gradient on outcomes following transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis (AS).nnnBACKGROUNDnLow flow (i.e., reduced stroke volume index [SVi]) can occur with both reduced and preserved LVEF. Low flow is often associated with low gradient despite severe stenosis and with worse outcomes following surgical aortic valve replacement. However, there are few data about the impact of low flow on outcomes following TAVR.nnnMETHODSnWe retrospectively analyzed the clinical, Doppler-echocardiographic, and outcome data prospectively collected in 639 patients who underwent TAVR for symptomatic severe AS in 2 Canadian centers.nnnRESULTSnIn this cohort, 334 (52.3%) patients had a low flow (SVi <35 ml/m(2)) and these patients had increased 30-day mortality (11.4 vs. 5.9%, p = 0.01), 2-year all-cause mortality (35.3 vs. 30.9%, p = 0.005), and 2-year cardiovascular mortality (25.7 vs. 16.8%, p = 0.01) compared with patients with normal flow. Reduced flow was an independent predictor of 30-day mortality (odds ratio: 1.94, p = 0.026), cumulative all-cause mortality (hazard ratio: 1.27 per 10 ml/m(2) SVi decrease, p = 0.016), and cumulative cardiovascular mortality (hazard ratio: 1.29 per 10 ml/m(2) decrease, p = 0.04). Despite significant association in univariable analyses, low LVEF and low mean gradient were not found to be independent predictors of outcomes in multivariable analyses.nnnCONCLUSIONSnLow flow but not low LVEF or low gradient is an independent predictor of early and late mortality following TAVR in high-risk patients with severe AS. SVi should be integrated in the risk stratification process of these patients.

Transcatheter aortic valve replacement with the St. Jude Medical Portico valve: first-in-human experience.

OBJECTIVESnThe purpose of this study was to demonstrate the feasibility and procedural outcomes with a new self-expanding and repositionable transcatheter heart valve.nnnBACKGROUNDnTranscatheter aortic valve replacement is a viable option for selected patients with severe symptomatic aortic stenosis. However, suboptimal prosthesis positioning may contribute to paravalvular regurgitation, atrioventricular conduction block, and mitral or coronary compromise.nnnMETHODSnThe repositionable Portico valve (St. Jude Medical, Minneapolis, Minnesota) was implanted in 10 patients with severe aortic stenosis utilizing percutaneous femoral arterial access. Patients underwent transthoracic and transesophageal echocardiography and multidetector computed tomography before and after valve implantation. Clinical and echocardiographic follow-up was obtained at 30 days.nnnRESULTSnDevice implantation was successful in all patients. Prosthesis recapture and repositioning was performed in 4 patients. Intermittent prosthetic leaflet dysfunction in 1 patient required implantation of a second transcatheter valve. There was 1 minor stroke. At 30-day follow-up, echocardiographic mean transaortic gradient was reduced from 44.9 ± 16.7 mm Hg to 10.9 ± 3.8 mm Hg (p < 0.001), and valve area increased from 0.6 ± 0.1 cm(2) to 1.3 ± 0.2 cm(2) (p < 0.001). Paravalvular regurgitation was mild or less in 9 patients (90%) and moderate in 1 patient (10%). There were no major strokes, major vascular complications, major bleeds, or deaths. No patient required pacemaker implantation. All patients were in New York Heart Association functional class II or less.nnnCONCLUSIONSnTranscatheter aortic valve replacement with the repositionable Portico transcatheter heart valve is feasible, with good short-term clinical and hemodynamic outcomes.

Sex Differences in Mortality After Transcatheter Aortic Valve Replacement for Severe Aortic Stenosis

OBJECTIVESnThe aim of this study was to examine sex differences in outcome after transcatheter aortic valve replacement (TAVR) with real-world data from 2 large centers in Canada.nnnBACKGROUNDnTranscatheter aortic valve replacement is an effective alternative to surgical valve replacement in symptomatic patients with severe aortic stenosis, but the impact of sex on outcomes remains unclear. The PARTNER (Placement of Aortic Transcatheter Valves) 1A trial demonstrated greater benefit of TAVR over surgery in women, but whether this was due to the poorer surgical outcome of women or better TAVR outcome, compared with men, is unknown.nnnMETHODSnConsecutive patients (n = 641) undergoing TAVR in Vancouver and Quebec City, Canada, were evaluated. Differences in all-cause mortality were examined with Kaplan-Meier estimates, adjusted logistic regression, and proportional hazards models.nnnRESULTSnWomen comprised 51.3% of the cohort. Balloon-expandable valves were used in 97% of cases, with transapical approach in 51.7 % women and 38.1% men. Women had more major vascular complications (12.4% vs. 5.4%, p = 0.003) and borderline significantly more major/life-threatening bleeds (21.6% vs. 15.8%, p = 0.08). At baseline, women had higher aortic gradients and worse renal function but better ejection fractions. Men had more comorbidities: prior myocardial infarction, prior revascularization, and chronic obstructive pulmonary disease. The adjusted odds ratio for 30-day all-cause mortality favored women, 0.39 (95% confidence interval: 0.19 to 0.80; p = 0.01), and this benefit persisted for 2 years, hazard ratio 0.60 (95% confidence interval: 0.41 to 0.88; p = 0.008).nnnCONCLUSIONSnFemale sex is associated with better short- and long-term survival after TAVR. Added to the PARTNER 1A findings, these results suggest TAVR might be the preferred treatment option for elderly women with symptomatic severe aortic stenosis.