Transapical Transcatheter Aortic Valve Replacement Research Articles

Transapical transcatheter aortic valve replacement for high risk elderly patients with predominant aortic incompetence

To introduce the application of the J-Valve™ system in elderly patients with predominant aortic incompetence without significant valve calcification, and to evaluate its feasibility. From April 2014 to July 2015, 33 cases of transapical implantation of J-Valve™ were performed in Department of Cardiac Surgery, Zhongshan Hospital, Fudan University. Sixteen of these patients were diagnosed as predominant aortic incompetence without significant valve calcification. There were 11 male and 5 female patients aged from 61 to 84 years, with a mean age of (76±6) years. All patients had symptoms of left ventricular dysfunction for at least 3 months. They were considered to be prohibitive for surgical valve replacement (logistic European system for cardiac operative risk evaluation: 22.2% to 44.4%, mean 27%±6% after evaluation by an interdisciplinary heart team. The J-Valve™ system was applied in transapical transcatheter aortic valve replacement for patients. The multi-slice CT was performed before discharge. Clinical evaluation including patients' history, symptoms and New York Heart Association classification and echocardiogram evaluation were performed before discharge, 1(st) month, 3(th) month and 12(th) month after the operation respectively. Implantations were successful in all patients. One patient died from moderate paravalvular leak which led to multi-organ failure during the hospital stay. The mean time of postoperative hospital stay of the other 15 patients was (6.1±1.3) days. The 15 patients were followed by 174 to 410 days, with a median time of 188 days. Only two patients had trivial prosthetic valve incompetence, the other 13 patients had no prosthetic valve incompetence; two patients had no paravavular leak and the other 13 patients had paravavular leak of no more than moderate grade. There were no major complication or mortality during the follow-up. The transapical implantation of the J-Valve™ system in high risk elderly patients with predominant aortic incompetence is feasible.The early postoperative outcome is satisfactory.

Invited Commentary

Invited Commentary

Reoperative transapical transcatheter aortic valve replacement for central aortic regurgitation

Paravalvular leak-related aortic regurgitation after transcatheter aortic valve replacement (TAVR) is a common complication and is associated with increased short- and long-term mortality. However, the impact of isolated central aortic regurgitation is unknown. We report a case of transapical (TA) TAVR with postprocedural central aortic regurgitation, who returned after two years with progression of regurgitation. A reoperative valve-in-valve TA-TAVR was performed.

The risk of acute kidney injury following transapical versus transfemoral transcatheter aortic valve replacement: a systematic review and meta-analysis

BackgroundThe aim of this systematic review is to examine the literature for the risk of acute kidney injury (AKI) in patients who underwent transcatheter aortic valve replacement (TAVR) based on transapical (TA) versus transfemoral (TF) approaches.MethodsA literature search was conducted utilizing Embase, Medline, Cochrane Database of Systematic Reviews and ClinicalTrials.gov from inception through December 2015. Studies that reported relative risk, odds ratio or hazard ratio comparing the AKI risk in patients who underwent TA-TAVR versus TF-TAVR were included. Pooled risk ratio (RR) and 95% confidence interval (CI) were calculated using a random effect, generic inverse variance method.ResultsSeventeen cohort studies with 5085 patients were enrolled in the analysis to assess the risk of AKI in patients undergoing TA-TAVR versus TF-TAVR. The pooled RR of AKI in patients who underwent TA-TAVR was 2.26 (95% CI 1.79–2.86) when compared with TF-TAVR. When meta-analysis was confined to the studies with adjusted analysis for confounders evaluating the risk of AKI following TAVR, the pooled RR of TA-TAVR was 2.89 (95% CI 2.12–3.94). The risk for moderate to severe AKI [RR 1.02 (95% CI 0.57–1.80)] in patients who underwent TA-TAVR compared with TF-TAVR was not significantly higher.ConclusionsOur meta-analysis demonstrates an association between TA-TAVR and a higher risk of AKI. Future studies are required to assess the risks of moderate to severe AKI and mortality following TA-TAVR versus TF-TAVR.

Transcatheter aortic valve replacement in nonagenarians: early and intermediate outcome from the OBSERVANT study and meta-analysis of the literature.

The purpose of this study was to evaluate the outcome of nonagenarians after transcatheter aortic valve replacement (TAVR) from the OBSERVANT study and to pool the results of the literature on this topic. Aortic stenosis is the most common acquired valvular heart disease in the Western countries, and its prevalence is linked to the phenomenon of population aging. TAVR can be considered as a wise approach to treat nonagenarians, but data on its safety and effectiveness are scarce. Data on 80 patients aged>90years who underwent TAVR from OBSERVANT study were analyzed. A systematic review and meta-analysis of published data were performed. Thirty-day mortality in the OBSERVANT series was 6.3%. None of these patients experienced stroke. Permanent pacemaker implantation was necessary in 20% of patients. Paravalvular regurgitation was observed in 57.5%. Survival at 1, 2, and 3years was 79.6, 71.9, and 61.5%. Ten series provided data on 1227 nonagenarians who underwent TAVR. Pooled 30-day mortality rate was 7.1%, stroke 2.8%, vascular access complication 8.8%, and permanent pacemaker implantation 10.6%. Paravalvular regurgitation was observed in 60.1% of patients. Pooled 1-, 2-, and 3-year survival rates were 79.2, 68.2, and 55.6%. Transapical TAVR was associated with a significantly higher risk of early mortality compared with transfemoral TAVR. The results of OBSERVANT study and aggregate data meta-analysis suggest that in nonagenarians, TAVR is associated with low postoperative morbidity and excellent intermediate survival. Transapical TAVR in these very elderly is associated with high postoperative mortality.

Transcatheter Aortic Valve Replacement in Low-Risk Patients Within the Observational Study of Effectiveness of SAVR–TAVI Procedures for Severe Aortic Stenosis Treatment Study

Transcatheter aortic valve replacement (TAVR) is a novel, disruptive technology that is revolutionizing the management of patients with aortic stenosis (AS). The landmark Placement of Aortic Transcatheter Valves (PARTNER) trial demonstrated that in patients with symptomatic severe AS who are not suitable for surgical aortic valve replacement (SAVR), TAVR significantly reduced the rates of death, with a number needed to treat only 5 patients to save 1 life at 5 years. In high-risk patients, the PARTNER trial demonstrated equivalent survival after TAVR using the Edwards Sapien balloon–expandable valve (Edwards Lifesciences, Corp, Irvine, CA) and SAVR although periprocedural risks differed with each procedure.1,2 Using the Medtronic self-expanding transcatheter heart valve (Medtronic, Inc, Minneapolis, MN), the CoreValve US Pivotal trial demonstrated the safety and efficacy of TAVR in extreme risk AS patients and superior survival with TAVR compared to SAVR in high-risk patients.3,4 These historic trials have generated unprecedented excitement and attention within the cardiology community. Cardiologists have eagerly pursued expanding indications, including, in large part, the expansion of this technology to healthier populations. Industry has also invested tremendously to rapidly address device pitfalls with novel transcatheter heart valve design iterations. Several valves are currently in development, and within a decade of the PARTNER trial, we are already commercially implanting third-generation devices. See Article by Rosato et al Soon after the completion of the aforementioned landmark trials, attention shifted to the use of TAVR in intermediate-risk patients. Multiple observational studies—primarily based on European centers—have attempted to elucidate comparative outcomes for TAVR and SAVR in intermediate-risk patients and have shown comparable short and midterm mortality between groups using propensity-score methodology.5–7 Piazza et al7 conducted an observational study derived from a large database (n=3666) of patients undergoing percutaneous and surgical AVR at 3 European …

Learning curves for transapical transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance, success, and safety

ObjectivesIntroduction of hybrid techniques, such as transapical transcatheter aortic valve replacement (TA-TAVR), requires skills that a heart team must master to achieve technical efficiency: the technical performance learning curve. To date, the learning curve for TA-TAVR remains unknown. We therefore evaluated the rate at which technical performance improved, assessed change in occurrence of adverse events in relation to technical performance, and determined whether adverse events after TA-TAVR were linked to acquiring technical performance efficiency (the learning curve). MethodsFrom April 2007 to February 2012, 1100 patients, average age 85.0 ± 6.4 years, underwent TA-TAVR in the PARTNER-I trial. Learning curves were defined by institution-specific patient sequence number using nonlinear mixed modeling. ResultsMean procedure time decreased from 131 to 116 minutes within 30 cases (P = .06) and device success increased to 90% by case 45 (P = .0007). Within 30 days, 354 patients experienced a major adverse event (stroke in 29, death in 96), with possibly decreased complications over time (P ∼ .08). Although longer procedure time was associated with more adverse events (P < .0001), these events were associated with change in patient risk profile, not the technical performance learning curve (P = .8). ConclusionsThe learning curve for TA-TAVR was 30 to 45 procedures performed, and technical efficiency was achieved without compromising patient safety. Although fewer patients are now undergoing TAVR via nontransfemoral access, understanding TA-TAVR learning curves and their relationship with outcomes is important as the field moves toward next-generation devices, such as those to replace the mitral valve, delivered via the left ventricular apex.

Results of surgical aortic valve replacement and transapical transcatheter aortic valve replacement in patients with previous coronary artery bypass grafting.

To evaluate the results of aortic valve replacement through sternotomic approach in redo scenarios (RAVR) vs transapical transcatheter aortic valve replacement (TAVR), in patients in the eighth decade of life or older already undergone previous coronary artery bypass grafting (CABG). One hundred and twenty-six patients undergoing RAVR were compared with 113 patients undergoing TaTAVR in terms of 30-day mortality and Valve Academic Research Consortium-2 outcomes. The two groups were also analysed after propensity-matching. TaTAVR patients demonstrated a higher incidence of 30-day mortality (P = 0.03), stroke (P = 0.04), major bleeding (P = 0.03), worse 'early safety' (P = 0.04) and lower permanent pacemaker implantation (P = 0.03). TaTAVR had higher follow-up hazard in all-cause mortality [hazard ratio (HR) 3.15, 95% confidence interval (CI) 1.28-6.62; P < 0.01] and cardiovascular mortality (HR 1.66, 95% CI 1.02-4.88; P = 0.04). Propensity-matched patients showed comparable 30-day outcome in terms of survival, major morbidity and early safety, with only a lower incidence of transfusions after TaTAVR (10.7% vs RAVR: 57.1%; P < 0.01). A trend towards lower Acute Kidney Injury Network Classification 2/3 (3.6% vs RAVR 21.4%; P = 0.05) and towards a lower freedom from all-cause mortality at follow-up (TaTAVR: 44.3 ± 21.3% vs RAVR: 86.6 ± 9.3%; P = .08) was demonstrated after TaTAVR, although cardiovascular mortality was comparable (TaTAVR: 86.5 ± 9.7% vs RAVR: 95.2 ± 4.6%; P = 0.52). Follow-up freedom from stroke, acute heart failure, reintervention on AVR and thrombo-embolisms were comparable (P = NS). EuroSCORE II (P = 0.02), perioperative stroke (P = 0.01) and length of hospitalization (P = 0.02) were the determinants of all-cause mortality at follow-up, whereas perioperative stroke (P = 0.03) and length of hospitalization (P = 0.04) impacted cardiovascular mortality at follow-up. Reported differences in mortality and morbidity after TaTAVR and RAVR reflect differences in baseline risk profiles. Given the lower trend for renal complications, patients at higher perioperative renal risk might be better served by TaTAVR.

Novel Percutaneous Apical Exclusion of a Left Ventricular Pseudoaneurysm After Complicated Transapical Transcatheter Aortic Valve Replacement

A 78-year-old woman with a history of coronary artery bypass grafting underwent transapical transcatheter aortic valve replacement with a Sapien XT (Edwards, Irvine, California) prosthesis that was complicated by an apical left ventricular pseudoaneurysm (LVPA). Unsuccessful attempts at closure

Abstract 18472: Electrocardiographic and Imaging Predictors for Permanent Pacemaker (PPM) Implantation Following Transcatheter Aortic Valve Replacement (TAVR)

Hypothesis: The purpose of this study was to identify predictors of permanent pacemaker (PPM) placement post-TAVR. Introduction: Cardiac conduction abnormalities requiring PPM are well-recognized complications of TAVR. Reliable predictors of post-TAVR PPM placement, however, remain elusive. Methods: A total of 114 patients who underwent trans-apical or trans-femoral TAVR using the balloon-expandable Edwards SAPIEN valve at the University of Iowa Hospitals and Clinics were identified. We then excluded patients with a pre-existing pacemaker and who required conversion to an open/salvage procedure. We performed a retrospective chart review aimed at abstracting raw data related to patient characteristics, EKG variables, imaging, procedural variables, outcomes, and follow-up data. Univariate and multivariate logistic regression was performed, with post-TAVR PPM implantation as the outcome. Results: A total of 100 patients were included in the study and PPM was placed in 9 patients (9%). AV block was the indication for all PPM. In univariate analysis, the ratio of valve size to diameter of Sinus of Valsalva was a significant predictor of PPM (84.1±9.3 vs 76.8±7.1, p=0.009) (Table 1). In multivariate analysis, using right bundle branch block (RBBB), sex and the ratio of valve size to diameter of Sinus of Valsalva as predictors, pre-existing (RBBB) (OR: 6.5, 95% CI: 1.1-37.1, p=0.035) was identified as a predictor of PPM and the ratio of valve size to diameter of Sinus of Valsalva (OR: 1.2, 95% CI: 1.03-1.3, p=0.012) was identified as a novel predictor of PPM. Conclusions: PPM placement was required in 9% of patients without pre-existing PPM who underwent TAVR. In addition to pre-existing RBBB, the ratio of valve size to diameter of Sinus of Valsalva was identified as a novel predictor of PPM after TAVR. Our findings differ from prior published manuscripts which reported valve size to LV outflow tract diameter ratio as a significant predictor of post-TAVR PPM implantation.

Immediate and Intermediate Outcome After Transapical Versus Transfemoral Transcatheter Aortic Valve Replacement

A few studies recently reported controversial results with transfemoral transcatheter aortic valve replacement (TF-TAVR) versus transapical transcatheter aortic valve replacement (TA-TAVR), often without adequate adjusted analysis for baseline differences. Data on patients who underwent TF-TAVR and TA-TAVR from the Observational Study of Effectiveness of avR-tavI procedures for severe Aortic stenosis Treatment study were analyzed with propensity score 1-to-1 matching. From a cohort of 1,654 patients (1,419 patients underwent TF-TAVR and 235 patients underwent TA-TAVR), propensity score matching resulted in 199 pairs of patients with similar operative risk (EuroSCORE II: TF-TAVR 8.1 ± 7.1% vs TA-TAVR, 8.4 ± 7.3%, p = 0.713). Thirty-day mortality was 8.0% after TA-TAVR and 4.0% after TF-TAVR (p = 0.102). Postoperative rates of stroke (TA-TAVR, 2.0% vs TF-TAVR 1.0%, p = 0.414), cardiac tamponade (TA-TAVR, 4.1% vs TF-TAVR 1.5%, p = 0.131), permanent pacemaker implantation (TA-TAVR, 8.7% vs TF-TAVR 13.3%, p = 0.414), and infection (TA-TAVR, 6.7% vs TF-TAVR 3.6%, p = 0.180) were similar in the study groups but with an overall trend in favor of TF-TAVR. Higher rates of major vascular damage (7.2% vs 1.0%, p = 0.003) and moderate-to-severe paravalvular regurgitation (7.8% vs 5.2%, p = 0.008) were observed after TF-TAVR. On the contrary, TA-TAVR was associated with higher rates of red blood cell transfusion (50.0% vs 30.4%, p = 0.0002) and acute kidney injury (stages 1 to 3: 44.4% vs 21.9%, p <0.0001) compared with TF-TAVR. Three-year survival rate was 69.1% after TF-TAVR and 57.0% after TA-TAVR (p = 0.006), whereas freedom from major adverse cardiovascular and cerebrovascular events was 61.9% after TF-TAVR and 50.4% after TA-TAVR (p = 0.011). In conclusion, TF-TAVR seems to be associated with significantly higher early and intermediate survival compared with TA-TAVR. The transfemoral approach, whenever feasible, should be considered the route of choice for TAVR.

Intracardiac Doppler Echocardiography for Monitoring of Pulmonary Artery Pressures in High-Risk Patients Undergoing Transcatheter Aortic Valve Replacement

Uncontrolled pulmonary hypertension may cause worse outcomes after transcatheter aortic valve replacement (TAVR), while hemodynamic monitoring is desirable for risk control. Pulmonary artery pressure (PAP) readings obtained by intracardiac Doppler echocardiography were evaluated. In 114 patients with symptomatic aortic stenosis and median Society of Thoracic Surgeons scores of 10.5% (interquartile range, 7.7%-15.0%), transfemoral and transapical TAVR was guided by intracardiac Doppler echocardiography. The continuous-wave Doppler beam interrogated the jet of tricuspid regurgitation from the "home view" position. Systolic PAP (PAPs) was estimated as the sum of the pressure gradient derived from the maximum transtricuspid regurgitation jet velocity and the central venous pressure. Mean PAP (PAPm) was calculated by the mean gradient method (1) and the Chemla formula (2). Measurements were obtained immediately before and after TAVR. Pre- and postinterventional readings showed marginal pressure underestimation in comparison with measurements derived from right-heart catheterization: PAPs, -2.7 (95% CI, -3.3 to 2.1) and -1.4 (95% CI, -1.9 to -0.9); PAPm by the mean gradient method, -1.9 (95% CI, -2.2 to -1.6) and -0.1 (95% CI, -0.4 to 0.2). Agreement (95% limits) for PAPs was -8.6 to 3.2 and -6.8 to 4.0; agreement for PAPm by the mean gradient method was -5.4 to 1.6 and -3.4 to 3.2. The repeatability coefficient (95% limits of agreement) for PAPs was excellent: 3.4 (-4.2 to 2.5) and 5.5 (-5.3 to 5.8); repeatability for PAPm was higher by the mean gradient method than by the Chemla method. In ≥ 85% of patients with pulmonary hypertension, PAPm improved after valve deployment. Intracardiac Doppler echocardiography-derived monitoring of PAP by the mean gradient method is accurate and well applicable to high-risk TAVR candidates for intraprocedural risk control.

SUPRASTERNAL DIRECT AORTIC TRANSCATHETER AORTIC VALVE REPLACEMENT AVOIDS STERNOTOMY, THORACOTOMY AND FEMORAL ACCESS: FIRST IN MAN EXPERIENCE

Transfemoral, transapical and conventional direct aortic TAVR patients have incisional morbidity that may delay ambulation and discharge. We evaluated the feasibility of direct aortic or innominate access for deployment of a transcatheter aortic valve using a novel suprasternal aortic access system without bony disruption or femoral instrumentation. Two patients with severe, symptomatic aortic stenosis at very high risk for conventional AVR (mean: age 82.5 years, STS predicted mortality 20%) but who were poor candidates for transfemoral or transapical valve delivery were consented for TAVR with the suprasternal aortic access system following Health Canada Special Access approval. This novel system includes a specially shaped, radiolucent trocar that combines internal illumination for direct visualization and an external stabilizer connected directly to the table to provide a motionless, hands free, retracted surgical field. The system is positioned under general anesthesia through a 3 cm incision above the sternal notch. The suprasternal aortic access system was successfully positioned with direct visualization and instrumentation of the aorta and innominate artery in both patients. A pigtail catheter placed via the radial artery provided aortography and facilitated valve positioning in combination with the axial control inherent to direct aortic approaches. Both Edwards Sapien XT valves were deployed with VARC-2 procedural success. Importantly, purse string suture placement, sheath insertion, precise valve positioning and hemostatic sheath removal all proved feasible through the stabilized suprasternal aortic access system without chest wall incision or bony disruption. Mean fluoroscopy times, radiation and contrast doses were 14 min, 2373 mGy and 68 ml respectively (n=2). Both patients were extubated in the operating room and experienced minimal incisional discomfort. Despite their complex co-morbidities, both patients were mobilized the day of surgery and discharged home on the second postoperative day with normally functioning bioprosthetic valves (mean gradient 11 mmHg, paravalvular regurgitation: none and trace, n=2). The suprasternal approach employing the suprasternal aortic access system enables direct axial valve positioning and avoids sternal/thoracotomy incisions and femoral access. Early mobilization is possible and likely expedites recovery. This innovative system creates a novel minimally invasive approach for high-risk patients with aortic stenosis. A multicenter clinical evaluation is underway.

Short- and mid-term results after transapical transcatheter aortic valve replacement in nonagenarians.

Recent reports have suggested that advanced age may preclude favorable outcomes in transcatheter aortic valve replacement (TAVR), particularly when performed via transapical (TA) access. However, detailed examinations of TA-TAVR in nonagenarian patients are lacking in the contemporary literature. We therefore describe our experience with 25 consecutive nonagenarians who underwent TA-TAVR and report their short- and mid-term outcomes. We identified all patients 90 years old or greater who underwent TA-TAVR between 2009-2014 at our institution. Demographic, comorbidity and echocardiographic data were obtained for all patients as were their in-hospital, 30-day, and 1-year outcomes. Overall survival was calculated using the Kaplan-Meier method. The mean Society of Thoracic Surgeons' predicted risk of mortality was 10.2% (SD±3.4). Twenty-four nonagenarians received TA-TAVR secondary to severe aortic stenosis while 1 had a valve-in-valve procedure for a regurgitant bioprosthetic valve. There were no conversions to open surgery, no aborted procedures, and no in-hospital deaths or strokes; 44% of patients (N.=11) were discharged to home. Five patients required cardiac rehospitalization within the first 30 days and 2 experienced strokes during the first year. Overall 30-day and 1-year survival were 100% and 83%, respectively. TA-TAVR can safely be performed on nonagenarians subjected to otherwise standard selection criteria. Chronology should not stand as a routine contraindication to this procedure; rather, comorbidities and functional status should define patient eligibility for TA-TAVR.

Clinical and Functional Outcomes Associated With Myocardial Injury After Transfemoral and Transapical Transcatheter Aortic Valve Replacement: A Subanalysis From the PARTNER Trial (Placement of Aortic Transcatheter Valves).

This study sought to clarify the clinical and echocardiographic prognostic implication of myocardial injury after transcatheter aortic valve replacement (TAVR). The clinical significance of cardiac biomarker elevation after TAVR remains unclear. Patients treated with TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) trial were divided into tertiles (T1, T2, T3) based on the difference between the values on post-procedure day 1 and the baseline values of 2 cardiac biomarkers: cardiac troponin I (ΔcTnI); and creatine kinase-myocardial band (ΔCK-MB) fraction. Patients were stratified according to their access route: transfemoral (TF) (n = 1,840) or transapical (TA) (n = 1,173). At 30 days after TF-TAVR, patients in the highest tertile (T3) of cardiac biomarker elevation had a higher rate of all-cause mortality (ΔcTnI: T3: 5.4% vs. T1: 0.5%, p = 0.006; ΔCK-MB: T3: 5.7% vs. T1: 0.9%, p = 0.006) and cardiovascular mortality (ΔcTnI: T3: 4.9% vs. T1: 0.5%, p = 0.01; ΔCK-MB: T3: 3.9% vs. T1: 0.5%, p = 0.02). At 1 year, only patients in the highest CK-MB tertile had higher rates of all-cause (25.4% vs. 16.8%, p = 0.02) and cardiovascular (10.3% vs. 5.0%) mortality. Multivariable analysis demonstrated that greater release of cardiac biomarkers was independently associated with increased mortality in the TF population. After TA-TAVR, being in the highest tertile of cardiac biomarker elevation had no influence on clinical and echocardiographic outcomes at 30 days and 1 year. After TF-TAVR, a greater degree of myocardial injury was associated with higher rates of 30-day all-cause and cardiovascular mortality. At 1 year, being in the highest tertile of ΔCK-MB was correlated with a higher rate of all-cause and cardiac mortality. Finally, the level of myocardial injury after TA-TAVR had no impact on clinical and echocardiographic outcomes.

Outcomes in Nonagenarians Undergoing Transcatheter Aortic Valve Replacement in the PARTNER-I Trial

This study describes short-term and mid-term outcomes of nonagenarian patients undergoing transfemoral or transapical transcatheter aortic valve replacement (TAVR) in the Placement of Aortic Transcatheter Valve (PARTNER)-I trial. From April 2007 to February 2012, 531 nonagenarians, mean age 93 ± 2.1 years, underwent TAVR with a balloon-expandable prosthesis in the PARTNER-I trial: 329 through transfemoral (TF-TAVR) and 202 transapical (TA-TAVR) access. Clinical events were adjudicated and echocardiographic results analyzed in a core laboratory. Quality of life (QoL) data were obtained up to 1 year post-TAVR. Time-varying all-cause mortality was referenced to that of an age-sex-race-matched US population. For TF-TAVR, post-procedure 30-day stroke risk was 3.6%; major adverse events occurred in 35% of patients; 30-day paravalvular leak was greater than moderate in 1.4%; median post-procedure length of stay (LOS) was 5 days. Thirty-day mortality was 4.0% and 3-year mortality 48% (44% for the matched population). By 6 months, most QoL measures had stabilized at a level considerably better than baseline, with Kansas City Cardiomyopathy Questionnaire (KCCQ) 72 ± 21. For TA-TAVR, post-procedure 30-day stroke risk was 2.0%; major adverse events 32%; 30-day paravalvular leak was greater than moderate in 0.61%; and median post-procedure LOS was 8 days. Thirty-day mortality was 12% and 3-year mortality 54% (42% for the matched population); KCCQ was 73 ± 23. A TAVR can be performed in nonagenarians with acceptable short- and mid-term outcomes. Although TF- and TA-TAVR outcomes are not directly comparable, TA-TAVR appears to carry a higher risk of early death without a difference in intermediate-term mortality. Age alone should not preclude referral for TAVR in nonagenarians.

Transapical and Transaortic Transcatheter Aortic Valve Replacement in the United States

When transcatheter aortic valve replacement (TAVR) cannot be carried out through transfemoral access, alternative access TAVR is indicated. The purpose of this study was to explore inhospital and 1-year outcomes of patients undergoing alternative access TAVR through the transapical (TA) or transaortic (TAo) techniques in the United States. Clinical records of 4,953 patients undergoing TA (n = 4,085) or TAo (n = 868) TAVR from 2011 to 2014 in The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry were linked to Centers for Medicare and Medicaid Services hospital claims. Inhospital and 1-year clinical outcomes were stratified by operative risk; and the risk-adjusted association between access route and mortality, stroke, and heart failure repeat hospitalization was explored. Mean age for all patients was 82.8 ± 6.8 years. The median STS predicted risk of mortality was significantly higher among patients undergoing TAo (8.8 versus 7.4, p < 0.001). When compared with TA, TAo was associated with an increased risk of unadjusted 30-day mortality (10.3% versus 8.8%) and 1-year mortality (30.3% versus 25.6%, p = 0.006). There were no significant differences between TAo and TA for inhospital stroke rate (2.2%), major vascular complications (0.3%), and 1-year heart failure rehospitalizations (15.7%). Examination of high-risk and inoperable subgroups showed that 1-year mortality was significantly higher for TAo patients classified as inoperable (p = 0.012). Patients undergoing TAo TAVR are older, more likely female, and have significantly higher STS predicted risk of mortality scores than patients operated on by TA access. There were no risk-adjusted differences between TA and TAo access in mortality, stroke, or readmission rates as long as 1 year after TAVR.

Device success and 30-day clinical outcome in patients undergoing preimplant valvuloplasty in transfemoral versus omitting valvuloplasty in transapical transcatheter aortic valve replacement

ObjectivesThe study objective was to evaluate the impact of preimplantation balloon valvuloplasty on procedural outcomes in high-risk or no-option patients with aortic stenosis undergoing Edwards Lifesciences (Irvine, Calif) Sapien valve placement. Paravalvular aortic regurgitation has been associated with long-term mortality after transcatheter aortic valve replacement. Whether omitting preimplant balloon valvuloplasty affects paravalvular aortic regurgitation after Edwards Sapien transcatheter aortic valve replacement is currently unknown. MethodsWe retrospectively analyzed the clinical outcome of 121 consecutive patients undergoing transapical (N = 50) or transfemoral (N = 71) Edwards Sapien transcatheter aortic valve replacement. Routinely, no preimplant balloon valvuloplasty was performed in transapical procedure as opposed to uniform preimplant balloon valvuloplasty in transfemoral cases. The incidence and severity of total and paravalvular aortic regurgitation and 30-day clinical outcomes were compared between the 2 cohorts. ResultsThe average patient's age was 84.4 years, with a higher prevalence of smoking history (68% vs 42%, P = .005) and peripheral vascular disease (38% vs 20%, P = .03) in the patients undergoing transapical replacement. The preprocedural transthoracic echocardiographic and computed tomography findings were similar between the 2 cohorts. After transcatheter aortic valve replacement, the incidence of mild to moderate total aortic regurgitation (42% transfemoral vs 38% transapical), paravalvular aortic regurgitation (39% transfemoral vs 30% transapical), device success (88.7% transfemoral vs 94.0% transapical), and 30-day composite end points (9.9% transfemoral vs 14.0% transapical) were comparable in both groups. Multivariate regression analysis revealed male gender (odds ratio, 2.7; 95% confidence interval, 1.18-6.35; P = .02) but not preimplant balloon valvuloplasty as an independent predictor for mild or greater total aortic regurgitation. ConclusionsCompared with transapical transcatheter aortic valve replacement without preimplant balloon valvuloplasty, preimplant balloon valvuloplasty before transfemoral transcatheter aortic valve replacement resulted in a similar degree of prosthesis-related regurgitation, device success, and 30-day composite safety outcomes.

Temporal Trends in Quality of Life Outcomes After Transapical Transcatheter Aortic Valve Replacement: A Placement of AoRTic TraNscathetER Valve (PARTNER) Trial Substudy.

In the Placement of AoRTic TraNscathetER Valve (PARTNER) randomized controlled trial (RCT), which represented the first exposure to transapical transcatheter aortic valve replacement (TA-TAVR) for many clinical sites, high-risk patients undergoing TA-TAVR derived similar health-related quality of life (HRQoL) outcomes when compared with surgical aortic valve replacement (SAVR). With increasing experience, it is possible that HRQoL outcomes of TA-TAVR may have improved. We evaluated HRQoL outcomes at 1-, 6-, and 12-month follow-ups among 875 patients undergoing TA-TAVR in the PARTNER nonrandomized continued access (NRCA) registry and compared these outcomes with those of the TA-TAVR and SAVR patients in the PARTNER RCT. HRQoL was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes Study Short-Form 12, and the EuroQoL-5D, with the KCCQ overall summary score serving as the primary end point. The NRCA TA-TAVR and RCT TA-TAVR and SAVR groups were generally similar. The primary outcome, the KCCQ summary score, did not differ between the NRCA TA-TAVR and the RCT TA-TAVR group at any follow-up timepoints, although there were small differences in favor of the NRCA cohort on several KCCQ subscales at 1 month. There were no significant differences in follow-up HRQOL between the NRCA-TAVR and the RCT SAVR cohorts on the KCCQ overall summary scale or any of the disease-specific or generic subscales. Despite greater experience with TA-TAVR in the NRCA registry, HRQoL outcomes remained similar to those of TA-TAVR in the original RCT cohort and no better than those with SAVR. These findings have important implications for patient selection for TAVR when transfemoral access is not an option. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

Circulation : Clinical Summaries

Brugada syndrome (BrS) is a hereditary cardiac disorder associated with an increased risk of fatal ventricular arrhythmias. BrS has been extensively studied at the molecular and cellular scales. However, the cardiac electrophysiological substrate that underlies the BrS ECG and supports ventricular arrhythmias in the intact heart of BrS patients has not been elucidated. This article reports the results of panoramic electrophysiological mapping using noninvasive ECG imaging in 25 BrS patients. The results indicate that the abnormal electrophysiological substrate is localized exclusively in the right ventricular outflow tract. The right ventricular outflow tract displays delayed activation, prolonged repolarization, and steep repolarization gradients. These findings reveal the existence of both abnormal repolarization and slow discontinuous conduction in the BrS substrate. Together, these properties provide conditions that promote sustained reentry. These observations have implications for the diagnosis and mechanism-based, targeted therapy of BrS arrhythmias. A related finding of clinical significance is the demonstrated capability of ECG imaging to differentiate BrS from right bundle-branch block based on differences in epicardial activation, repolarization, and electrogram morphologies. See p 1950. After the initial human implantation in 2000, transcatheter pulmonary valve (TPV) replacement with the Melody valve was introduced in the United States in 2007 through a prospective, multicenter Investigational Device Exemption trial. Early and short-term …