Long term mortality and readmissions after transcatheter aortic valve replacement.

BACKGROUND: Readmissions following transcatheter aortic valve replacement (TAVR) are common but detailed analysis of cardiac and non-cardiac inpatient readmissions beyond thirty days to different levels of care are limited. METHODS: Our study population was 1,037 consecutive patients who underwent TAVR between 2011-2017 within a multi-hospital quaternary health system. A retrospective chart review was performed and readmissions were adjudicated and classified based on primary readmission diagnosis (cardiac versus noncardiac) and level of care [intensive care unit (ICU) admission vs. non-ICU admission]. Incidence, causes, and outcomes of readmissions to up to three years post procedure were evaluated. RESULTS: Of the 1,017 patients who survived their index hospitalization, there were readmissions due to noncardiac causes in 350 (34.4%) and cardiac causes in 208 (20.5%) during a mean 1.96 years of follow-up. The most common non-cardiac causes of readmission were sepsis/infection (14.3%), gastrointestinal (8.3%), and respiratory (4.8%), whereas heart failure (14.0%) and arrhythmias (4.6%) were the most common cardiac causes of readmission. A total of 191 (18.8%) patients were readmitted to the ICU and 372 patients (36.6%) were non-ICU readmissions. The risk of a noncardiac readmission was highest in the period immediately following TAVR (~4.5% per month) with an early high hazard phase that gradually declined over months. However, the risk of cardiac readmission remained stable at ~1% per month throughout. TAVR patients that were readmitted for any cause had markedly increased mortality; this was especially true for patients readmitted to an ICU. CONCLUSIONS: In TAVR patients who survived their index hospitalization, non-cardiac readmissions were more prevalent than cardiac. The risk of readmission and subsequent mortality was highest immediately post-procedure and declined thereafter. Readmission to ICU portends the highest risk of subsequent death in this cohort. Patient baseline co-morbidities are an important consideration for TAVR patients and play a significant role in readmissions and outcomes.

Relationship between predicting bleeding complication in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score and mortality among patients with atrial fibrillation undergoing percutaneous coronary intervention.

BACKGROUND: The predicting bleeding complication in patients undergoing stent implantation and subsequent dual antiplatelet therapy, PRECISE-DAPT (P-DAPT) score has been validated in large cohorts as an effective tool in predicting bleeding complication after dual antiplatelet therapy (DAPT) as well as in predicting in-hospital mortality. The implication of using this score to predict outcomes, including mortality in patients with atrial fibrillation (AF) undergoing PCI is unknown. OBJECTIVE: Role of P-DAPT score to study clinical outcomes, including mortality, hospitalization, and major bleeding, particularly among patients with AF. METHODS: This is a retrospective observational study of 18,850 consecutive patients who underwent percutaneous coronary intervention (PCI) across a large multihospital healthcare system from 2010 to 2019. Patients were stratified into four groups depending on the presence or absence of AF and P-DAPT score, with score ≥ 25 defined as high risk. The primary outcome was all-cause mortality. The secondary outcomes evaluated were hospitalization and major bleeding. RESULTS: In the unadjusted analyses, a P-DAPT score ≥ 25, in both AF and non-AF population, was associated with increased mortality, hospitalization, and bleeding. After adjusting for baseline covariates, no significant differences in major bleeding risk were found across the four groups. However, a P-DAPT score of ≥25 in AF patients was associated with a higher risk for hospitalizations related to cardiovascular causes (HR: 2.15 95% CI 2.00-2.3, p < .0001). Among AF patients, P-DAPT score ≥ 25 was found to be strongly associated with mortality (HR 3.5; 95% CI 2.95-4.25, p < .0001) as compared with AF patients with score < 25 (HR 1.18, 95% CI 0.88-1.54, p = .26). CONCLUSION: In this large cohort of patients undergoing PCI, the P-DAPT score can help to identify patients at high risk for long-term mortality, particularly among those with atrial fibrillation.

Urgent transcatheter aortic valve replacement may be performed with acceptable long-term outcomes.

BACKGROUND: The wide availability of transcatheter aortic valve replacement (TAVR) and broadening of its indications to most patients with aortic stenosis may increase its utilization in the urgent setting. However, a comparison of long-term outcomes of patients undergoing urgent TAVR when compared to elective TAVR have not been well studied. METHODS: All patients that underwent TAVR from 2011 to 2018 were included. Primary outcomes included operative (30-day), 1-, and 5-year survival and readmissions. RESULTS: The total patient population undergoing TAVR was divided into urgent (n = 247) and elective (n = 946) cohorts. Thirty days mortality (6.5% vs. 2.3%; p = .001), acute kidney injury (2.8% vs. 0.6%; p = .003), and length of stay (12 vs. 3 days; p < .001) were higher for the urgent cohort. There was no significant difference between cohorts for 30-day all-cause (14.6% vs. 10.8%; p = .097) readmissions. Freedom from readmission for heart failure at 1-year (73.6% vs. 83.4%; p < .001) was lower for the urgent cohort. One- (79.0% vs. 87.1%; p < .001) and five-year (39.6% vs. 43.5%; p = .005) survival was lower for the urgent cohort. This difference was eliminated after risk adjustment (hazard ratio [HR]: 1.3; p = .158 and HR: 1.1; p = .639, respectively). CONCLUSION: Unadjusted survival was significantly worse for the urgent cohort up to 1 year. This trend continued for 5-year survival, however, after risk adjustment there was no significant difference in survival between cohorts. Although urgent TAVR is associated with increased periprocedural risk due to more comorbid disease, outcomes and long-term survival are encouraging and support the consideration of urgent TAVR as a viable alternative for this patient population.

Longitudinal Outcomes of Nonagenarians Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has emerged as the preferred alternative to surgical aortic valve replacement in elderly patients. However, the long-term outcomes of nonagenarians undergoing TAVR are unknown. METHODS: Octogenarian and nonagenarian patients undergoing TAVR from 2011 to 2018 were identified from a prospectively maintained institutional database. Cox proportional hazards regression was used for baseline-adjusted outcome comparison and risk prediction. Survival was compared with age and gender-matched population from the Social Security Actuarial Life Table. RESULTS: A total of 649 (54.4%) octogenarians and 157 (13.2%) nonagenarians underwent TAVR. Nonagenarians had a lower body mass index (P < .001), smaller BSA (P < .001), and a lower prevalence of chronic obstructive pulmonary disease (P = .023) but a higher Society of Thoracic Surgeons score (P < .001). The majority of nonagenarians and octogenarians were treated using self-expandable valves (60.3% vs 60.9%; P = .888) via transfemoral access (86.0% vs 81.0%; P = .148). At 30 days, 1 year, and 4 years, there was no difference in survival (95.5%, 80.3%, and 51.2% vs 96.9%, 87.4, and 57.6%, respectively) (adjusted hazard ratio [HR], 0.8; P = .205) and hospital readmissions for cardiac causes (7.9%, 25.7%, and 53.7% vs 10.3%, 27.9%, and 52.0%, respectively) (adjusted HR, 0.9; P = .488). Further, nonagenarians had a survival comparable to an age-matched and sex-matched U.S. population (P = .540). Post-TAVR paravalvular leak (HRs: 3.23 [P = .042] vs 2.66 [P = .032]) and anemia (HRs: 0.64 [P = .002] vs 0.80 [P = .004]) were associated with worse outcomes at 1 year. CONCLUSIONS: TAVR can be performed safely in nonagenarians, with comparable outcomes to younger patients approximating natural life expectancy. This age paradox should strengthen the role of TAVR in well selected nonagenarians by the heart team.

Outcomes of Current-Generation Transfemoral Balloon-Expandable Versus Self-Expandable Transcatheter Aortic Valve Replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) continues to gain momentum with current-generation balloon-expandable (BE) Edwards SAPIEN 3 (Edwards Lifesciences, Irvine, CA) and self-expandable (SE) Medtronic Evolut valves (Medtronic, Minneapolis, MN). Safety and efficacy of each device has been studied independently but head-to-head comparisons remain limited. METHODS: The institutional database was used to identify patients undergoing TAVR with BE and SE systems through transfemoral access between 2015 and 2018. Patients with an alternative access were excluded. Multivariable logistic and Cox proportional hazards regression was used to compare baseline risk-adjusted 30-day Valve Academic Research Consortium-2 variables and midterm outcomes, including survival, stroke, and readmission rates. RESULTS: A total of 294 BE (52.2%) and 269 SE (47.8%) valves were implanted. BE cohort was predominantly male (59.9% vs 33.1%, P < .001), with a larger body surface area (1.9 m2 vs 1.8 m2, P < .001), fewer prior aortic valve replacements (3.7% vs 10.0%, P = .003), and a lower Society of Thoracic Surgeons predicted risk of mortality score (4.9% vs 6.7%, P < .001). After risk adjustment, SE patients had a higher propensity of ischemic stroke at 30 days (6.0% vs 1.4%, P = .015) but were comparable in other Valve Academic Research Consortium-2 variables, including mortality (1.7% vs 3.4%, P = .474), pacemaker (12.7% vs 15.2%, P = .162), and moderate paravalvular leak (1.8% vs 3.2%, P = .165). Over the midterm, SE and BE were comparable in mortality (adjusted hazard ratio [aHR], 1.24; P = .269), all-cause readmission (aHR, 0.92; P = .576), and stroke rate (aHR, 1.97; P = .061). CONCLUSIONS: Midterm outcomes of both valve types were comparable despite a higher risk of short-term stroke for the SE cohort. Select patients may benefit from one valve type over another based on clinical and anatomic risk factors.

Impact of Combined Pre and Postcapillary Pulmonary Hypertension on Survival after Transcatheter Aortic Valve Implantation.

We aimed to evaluate the association between pulmonary hypertension (PH) hemodynamic classification and all-cause mortality in patients with symptomatic severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). PH is common and associated with post-TAVI outcomes in patients with severe AS. Although PH in these patients is primarily driven by elevated left-sided pressures (postcapillary PH), some patients develop increased pulmonary vascular resistance (PVR) configuring the combined pre- and postcapillary PH (CpcPH). We analyzed severe AS patients with mean pulmonary artery pressure (mPAP) measured by right heart catheterization (RHC) before TAVI between 2011 and 2017. PH hemodynamic classification was defined as: No PH (mPAP < 25 mm Hg); precapillary PH (mPAP ≥ 25 mm Hg, pulmonary capillary wedge pressure (PCWP) ≤15 mm Hg); isolated postcapillary PH (IpcPH; mPAP ≥ 25 mm Hg, PCWP > 15 mm Hg, PVR ≤ 3 Wood units (WU); CpcPH (mPAP ≥ 25 mm Hg, PCWP > 15 mm Hg, PVR > 3 WU). Kaplan-Meier and Cox regression analyses were used to test the association of PH hemodynamic classification with post-TAVI all-cause mortality. We examined 561 patients (mean age 82 ± 8 years, 51% men, mean LVEF 54 ± 14%). The prevalence of no PH was 201 (36%); precapillary PH, 59 (10%); IpcPH, 189 (34%); and CpcPH, 112 (20%). During a median follow-up of 30 months, 240 all-cause deaths occurred. Patients with CpcPH had higher mortality than those with no-PH even after adjustment for baseline characteristics (Hazard ratio 1.56, 95% confidence interval 1.06 to 2.29, p = 0.025). There was no survival difference among patients with non-PH, precapillary PH and IpcPH. In conclusion, for patients with symptomatic severe AS treated with TAVI, CcpPH is independently associated with long-term all-cause mortality despite successful TAVI.

Impact of Perioperative Stroke on Midterm Outcomes After Transcatheter Aortic Valve Replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has evolved as an alternative therapy to open aortic valve replacement in most patients with aortic stenosis. Stroke associated with TAVR can be a devastating complication in the short term; however, little is known regarding midterm outcomes. METHODS: All patients undergoing TAVR at the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania from 2011 to 2018 were included. Modified Rankin Scale values as a measurement of stroke-related disability were extracted for patients who had neurologic deficits. RESULTS: Neurologic events (NEs) developed in 51 (4.3%) of the 1193 patients during the study period (32 [2.7%] had disabling strokes; 19 [1.6%] had nondisabling strokes, including 5 [0.4%] transient ischemic attacks). Patients who had TAVR-related NEs were older (85.8 ± 4.2 years vs 81.5 ± 7.9 years; P < .001) and predominantly female (68.6% vs 31.4%; P = .007), but they were comparable in terms of The Society of Thoracic Surgeons predicted mortality score and vascular access. Patients with NEs had increased short term and midterm mortality (15.7% vs 2.6%, 29.4% vs 13.9%, and 47.1% vs 35.7% at 30 days, 1 year, and 3 years, respectively). Severity of disability, determined by the modified Rankin Scale, was a risk factor for 30-day mortality (HR, 5.8; P = .003), 1-year mortality (HR, 2.1; P < .001) and 3-year mortality (HR, 1.8; P < .001). Predictors of TAVR NEs were older age (odds ratio [OR] per year of age, 1.11; P = .001), low body surface area (OR per m2, 0.22; P = .050), procedural duration (OR per minute, 1.01; P = .024), and administration of blood products (OR, 3.23; P = .002). CONCLUSIONS: Stroke increases short-term and midterm mortality after TAVR. Risk prediction for neurologic events in TAVR could aid the framework for patient selection and further improve outcomes.

Mitral Regurgitation in Low-Flow, Low-Gradient Aortic Stenosis Patients Undergoing TAVR: Insights From the TOPAS-TAVI Registry.

OBJECTIVES: This study sought to determine the incidence, clinical impact, and changes over time of mitral regurgitation (MR) in patients with low-flow, low-gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Few data exist on the clinical impact and changes in severity over time of MR in patients with LFLG-AS undergoing TAVR. METHODS: A total of 308 TAVR candidates with LFLG-AS were included. Patients were categorized according to MR severity at baseline, and presence of MR improvement at 12-month follow-up. Clinical outcomes were assessed at 1 and 12 months (+ echocardiography), and yearly thereafter. RESULTS: Baseline mild and moderate-to-severe MR were present in 118 (38.3%) and 115 (37.3%) patients, respectively. MR was of functional and mixed etiology in 77.2% and 22.7% of patients, respectively. A total of 131 patients (42.5%) died after a median follow-up of 2 (1 to 3) years. Baseline moderate-or-greater MR had no impact on mortality (hazard ratio [HR]: 1.34; 95% confidence interval [CI]: 0.72 to 2.48) or heart failure hospitalization (HR: 1.02; 95% CI: 0.49 to 2.10). At 1-year follow-up, MR improved in 44.3% of patients and remained unchanged/worsened in 55.7%. The lack of MR improvement was associated with a higher risk of all-cause and cardiac mortality (HR: 2.02; 95% CI: 1.29 to 3.17; HR: 3.03; 95% CI: 1.27 to 7.23, respectively), rehospitalization for cardiac causes (HR: 1.50; 95% CI: 1.04 to 2.15), and an increased overall-mortality/heart failure rehospitalization (HR: 1.94; 95% CI: 1.25 to 3.02). A higher baseline left ventricular end-diastolic diameter and a higher increase in left ventricular ejection fraction were found to be independent predictors of MR improvement at 1-year follow-up (odds ratio: 0.69; 95% CI: 0.51 to 0.94; and odds ratio: 0.81; 95% CI: 0.67 to 0.96, respectively). CONCLUSIONS: Most TAVR candidates with LFLG-AS had some degree of MR, of functional origin in most cases. MR improved in about one-half of patients, with larger left ventricular size and a higher increase in left ventricular ejection fraction post-TAVR determining MR improvement over time. The lack of MR improvement at 1 year was associated with poorer outcomes.

Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial.

Background As transcatheter aortic valve replacement expands to younger and/or lower risk patients, the long-term consequences of permanent pacemaker implantation are a concern. Pacemaker dependency and impact have not been methodically assessed in transcatheter aortic valve replacement trials. We report the incidence and predictors of pacemaker implantation and pacemaker dependency after transcatheter aortic valve replacement with the Lotus valve. Methods and Results A total of 912 patients with high/extreme surgical risk and symptomatic aortic stenosis were randomized 2:1 (Lotus:CoreValve) in REPRISE III (The Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System-Randomized Clinical Evaluation) trial. Systematic assessment of pacemaker dependency was pre-specified in the trial design. Pacemaker implantation within 30 days was more frequent with Lotus than CoreValve. By multivariable analysis, predictors of pacemaker implantation included baseline right bundle branch block and depth of implantation; diabetes mellitus was also a predictor with Lotus. No association between new pacemaker implantation and clinical outcomes was found. Pacemaker dependency was dynamic (30 days: 43%; 1 year: 50%) and not consistent for individual patients over time. Predictors of pacemaker dependency at 30 days included baseline right bundle branch block, female sex, and depth of implantation. No differences in mortality or stroke were found between patients who were pacemaker dependent or not at 30 days. Rehospitalization was higher in patients who were not pacemaker dependent versus patients without a pacemaker or those who were dependent. Conclusions Pacemaker implantation was not associated with adverse clinical outcomes. Most patients with a new pacemaker at 30 days were not dependent at 1 year. Mortality and stroke were similar between patients with or without pacemaker dependency and patients without a pacemaker. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier NCT02202434.

Longitudinal Outcomes of Women Undergoing Transcatheter Aortic Valve Replacement.

OBJECTIVE: Recent data have suggested that women have a survival benefit at 1-year follow-up. However, long-term gender-based TAVR outcomes are lacking. METHODS: All patients undergoing isolated TAVR from 2011 to 2017 were included. Patients were stratified by gender. The primary outcomes of the study were 3-year mortality and 3-year hospital readmissions. Multivariable logistic regression analysis was used to evaluate the risk-adjusted impact of gender on TAVR outcomes. RESULTS: A total of 1,036 patients were divided into male (n = 518) and female (n = 518) cohorts. Women had a borderline significantly increased STS PROM (8.3% ± 5 vs. 7.7% ± 4.4; P = 0.05). The majority of procedures were performed under conscious sedation (male: 89% vs. female: 88%; P = 0.62) and via transfemoral access (male: 81.8% vs. female: 81.4%; P = 0.46). There was no difference in operative (30-day) mortality (male: 15 [3.3%] vs. female: 17 [3.7%]; P = 0.77) or 30-day readmissions (male: 40 [10.8%] vs. female: 44 [12.2%]; P = 0.56). Perioperative blood product usage was higher for women (male: 8.1% vs. female: 14.1%; P = 0.002). There was no significant difference in major vascular complications (male: 0.4% vs. female: 1.0%; P = 0.26) or major bleeding (male: 0.2% vs. female: 0.4%; P = 0.56). Permanent pacemaker placement was higher for males (11.6% vs. 7.0%; P = 0.01). On risk-adjusted multivariable analysis, gender was not a factor associated with mortality (HR 0.99 [0.76 to 1.30]; P = 0.99) or readmission (HR 0.90 [0.72 to 1.14]; P = 0.42) at 5 years. CONCLUSIONS: There was no difference in survival or readmissions on multivariable analysis for women undergoing TAVR at 3 years. Longitudinal multi-institutional data will be important to validate these findings.

Long-term Hospital Readmissions After Surgical Vs Transcatheter Aortic Valve Replacement.

BACKGROUND: Limited data exist for rates and causes of readmission beyond short-term follow-up for patients undergoing surgical and transcatheter aortic valve replacement (SAVR and TAVR) METHODS: Patients undergoing isolated SAVR and TAVR between 2011 and 2017 at our institution were included in this study. The primary outcome was 5-year hospital readmission. The readmission cohort was identified from index readmission. Multivariable logistic regression analysis was used to evaluate the risk-adjusted impact of TAVR vs SAVR on outcomes. RESULTS: A total of 2379 patients were included: 1034 TAVR (43.5%) and 1345 SAVR (56.5%). Patients undergoing TAVR were on average older (81.8 ± 7.8 years vs 69.1 ± 11.85 years, P < .0001) and had more comorbidities than SAVR patients as represented by a greater Society of Thoracic Surgeons Predicted Risk of Mortality (7.96% ± 4.71% vs 2.73% ± 2.93%, P < .0001). Operative mortality was higher in the TAVR cohort (3.19% vs 1.12%, P < .004) and remained high at 5 years despite risk adjustment. Significantly more cardiac readmissions were found at 5-year follow-up in the TAVR group (73.3% vs 60.0%, P < .0001). Heart failure was the most common cause of cardiac readmission in the TAVR cohort (58.7% vs 42.1%, P = .0001). No difference was found in overall readmission risk at 30 days (hazard ratio [HR] 1.23, 95% confidence interval [CI]: 0.94 to 1.61, P = .12), 1 year (HR 0.93, 95% CI: 0.77 to 1.16, P = .52), and 5 years (HR 0.99, 95% CI: 0.83 to 1.18, P = .89). CONCLUSIONS: There is a disproportionately high rate of long-term hospital readmissions for cardiac causes, including heart failure, in patients who underwent TAVR. These data may support aggressive medical management of patients with careful follow-up in patients undergoing TAVR.

Association of Structural and Functional Cardiac Changes With Transcatheter Aortic Valve Replacement Outcomes in Patients With Aortic Stenosis.

Importance: Severe aortic stenosis causes pressure overload of the left ventricle, resulting in progressive cardiac dysfunction that can extend beyond the left ventricle. A staging system for aortic stenosis has been recently proposed that quantifies the extent of structural and functional cardiac changes in aortic stenosis. Objectives: To confirm the reproducibility of a proposed staging system and expand the study findings by performing a survival analysis and to evaluate the association of aortic stenosis staging with both cardiac and noncardiac post-transcatheter aortic valve replacement (TAVR) readmissions. Design, Setting, and Participants: A cohort analysis was conducted involving patients with severe aortic stenosis who underwent TAVR at the University of Pittsburgh Medical Center between July 1, 2011, and January 31, 2017. Patients who had undergone TAVR for valve-in-valve procedures and had an incomplete or unavailable baseline echocardiogram study for review were excluded. Clinical, laboratorial, and procedural data were collected from the Society of Thoracic Surgeons database and augmented by electronic medical record review. Exposures: The aortic stenosis staging system is based on echocardiographic markers of abnormal cardiac function. The stages are as follows: stage 1 (left ventricle changes - increased left ventricular mass index; early mitral inflow to early diastolic mitral annulus velocity (E/e') >14; and left ventricular ejection fraction <50%), stage 2 (left atrial or mitral changes - left atrial volume index >34 mL/m2; moderate to severe mitral regurgitation; and atrial fibrillation), stage 3 (pulmonary artery or tricuspid changes - pulmonary artery systolic pressure ≥60 mm Hg; moderate to severe tricuspid regurgitation), and stage 4 (right ventricle changes - moderate to severe right ventricle dysfunction). Main Outcomes and Measures: Primary outcome was post-TAVR all-cause mortality. Secondary outcomes were composite outcomes of all-cause mortality and post-TAVR all-cause and cardiac-cause readmissions. Results: A total of 689 consecutive patients (351 [50.9%] were male, with a mean [SD] age of 82.4 [7.6] years) were included. The prevalence of stage 1 was 13%; stage 2, 62%; stage 3, 21%; and stage 4, 4%. Patients with higher staging had a greater burden of comorbidities as captured by the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM). Despite adjustment for STS-PROM, a graded association was found between aortic stenosis staging and all-cause mortality (hazard ratio [HR] stage 2 vs stage 1: 1.37 [95% CI, 0.81-2.31; P = .25]; stage 3 vs stage 1: 2.24 [95% CI, 1.28-3.92; P = .005]; and stage 4 vs stage 1: 2.83 [95% CI, 1.39-5.76; P = .004]). Stage 3 patients had higher post-TAVR readmission rates for both cardiac (HR, 1.84; 95% CI, 1.13-3.00; P = .01) and noncardiac causes. Conclusions and Relevance: Aortic stenosis staging appears to show a strong graded association between the extent of cardiac changes and post-TAVR all-cause mortality; such staging may improve patient care, risk stratification, assessment of prognosis, and shared decision making for patients undergoing TAVR.

Right ventricle to pulmonary artery coupling in patients undergoing transcatheter aortic valve implantation.

OBJECTIVES: To evaluate the prognostic value of the ratio between tricuspid annular plane systolic excursion (TAPSE)-pulmonary artery systolic pressure (PASP) as a determinant of right ventricular to pulmonary artery (RV-PA) coupling in patients undergoing transcatheter aortic valve replacement (TAVI). BACKGROUND: RV function and pulmonary hypertension (PH) are both prognostically important in patients receiving TAVI. RV-PA coupling has been shown to be prognostic important in patients with heart failure but not previously evaluated in TAVI patients. METHODS: Consecutive patients with severe aortic stenosis who received TAVI from July 2011 through January 2016 and with comprehensive baseline echocardiogram were included. All individual echocardiographic images and Doppler data were independently reviewed and blinded to the clinical information and outcomes. Cox models quantified the effect of TAPSE/PASP quartiles on subsequent all-cause mortality while adjusting for confounders. RESULTS: A total of 457 patients were included with mean age of 82.8±7.2 years, left ventricular ejection fraction (LVEF) 54%±13%, PASP 44±17 mm Hg. TAPSE/PASP quartiles showed a dose-response relationship with survival. This remained significant (HR for lowest quartile vs highest quartile=2.21, 95% CI 1.07 to 4.57, p=0.03) after adjusting for age, atrial fibrillation, LVEF, stroke volume index, Society of Thoracic Surgeons Predicted Risk of Mortality. CONCLUSION: Baseline TAPSE/PASP ratio is associated with all-cause mortality in TAVI patients as it evaluates RV systolic performance at a given degree of afterload. Incorporation of right-side unit into the risk stratification may improve optimal selection of patients for TAVI.

Open Surgical Access for Transfemoral TAVR Should Not Be a Contraindication for Conscious Sedation.

OBJECTIVES: The use of monitored anesthesia care (MAC) for transcatheter aortic valve replacement (TAVR) is gaining favor in the United States, although general anesthesia (GA) continues to be common for these procedures. Open surgical cutdown for transfemoral TAVR has been a relative contraindication for TAVR with MAC at most centers. The objective of this study was to review the authors' results of transfemoral TAVR performed in patients with open surgical cutdown with the use of MAC. DESIGN: Retrospective study design from a prospectively recorded database. SETTING: Tertiary academic (teaching) hospital. PARTICIPANTS: Two hundred eighty-two patients undergoing transfemoral TAVR with open surgical cutdown under MAC from 2015 to 2017. INTERVENTIONS: Transfemoral TAVR under MAC with surgical cutdown for femoral vascular access. MEASUREMENTS AND MAIN RESULTS: The study cohort consisted of 282 patients with severe aortic stenosis (mean area 0.65 [± 0.16] cm2, mean gradient of 48.9 [±13.3] mmHg, and mean age of 82.7 [± 7.31] years). Eleven (3.9%) patients required conversion to GA. First postoperative pain score (0-10) was 2.9 and highest postoperative pain score was 4.6. Major and minor vascular complications occurred in 2 (0.7%) and 6 (2.1%) patients, respectively. Twenty-nine (10.3%) patients were readmitted within 30 days, and 6 (2.1%) patients had in-hospital mortality. CONCLUSIONS: Open surgical cutdown for transfemoral TAVR can be performed safely using MAC and ilioinguinal block with low rates of conversion to general anesthesia and acceptable postoperative outcomes and pain scores.

Outcomes From Transcatheter Aortic Valve Replacement in Patients With Low-Flow, Low-Gradient Aortic Stenosis and Left Ventricular Ejection Fraction Less Than 30%: A Substudy From the TOPAS-TAVI Registry.

Importance: In low-flow, low-gradient aortic stenosis (LFLG AS), the severity of left ventricular dysfunction remains a key factor in the evaluation of aortic valve replacement. Objective: To evaluate the clinical outcomes and changes in left ventricular ejection fraction (LVEF) after transcatheter aortic valve replacement (TAVR) in patients with LFLG AS and severe left ventricular dysfunction. Design, Setting, and Participants: This multicenter registry is a substudy of the True or Pseudo-Severe Aortic Stenosis-TAVI registry that included patients with classic LFLG AS, defined as a mean transvalvular gradient less than 35 mm Hg, an effective orifice area less than 1.0 cm2, and an LVEF of 40% or less. Patients were divided in groups with very low (<30%) LVEF and low (30%-40%) LVEF. Dobutamine stress echocardiography (DSE) was performed before TAVR in a subset with very low LVEF, and presence of contractile reserve was defined as an increase of 20% or more in stroke volume. Clinical outcomes were assessed at 1 and 12 months and yearly thereafter, and echocardiography was performed at 1-year follow-up. Retrospective data were collected from 2007 to 2013 and prospective data from January 2013 to March 2018. Data were analyzed from March to October 2018. Exposures: Transcatheter aortic valve replacement in patients with LFLG AS. Main Outcomes and Measures: Changes in LVEF over time; periprocedural and late mortality. Results: A total of 293 patients were included, including 128 (43.7%) with very low LVEF and 165 with low LVEF (56.3%). Their mean (SD) age was 80 (7) years, and most (214 [73.0%]) were men. The mean (SD) LVEF in the very low LVEF group was 22% (5%), compared with 37% (7%) in the low LVEF group (P < .001). There were no differences between groups in rates of periprocedural mortality and late mortality (median [interquartile range], 23 [6-38] months). Patients with very low LVEF displayed a greater increase in LVEF at the 1-year follow-up examination (mean absolute increase, 11.9% [95% CI, 8.8%-15.1%]), than the low LVEF group (3.6% [95% CI, 1.1%-6.1%]; P < .001). In 92 patients with very low LVEF who had preprocedural DSE, results showed a lack of contractile reserve in 45 (49%), but this had no effect on clinical outcomes or changes in LVEF over time. Conclusions and Relevance: In patients with LFLG AS and severe left ventricular dysfunction, TAVR was associated with similar clinical outcomes as in counterparts with milder left ventricular dysfunction. The TAVR procedure was associated with a significant increase in LVEF, irrespective of contractile reserve. These results support TAVR for LFLG AS, irrespective of the severity of left ventricular dysfunction and DSE results.

Surgical cut down for vascular access with conscious sedation for transcatheter aortic valve replacement: the best of both worlds?

OBJECTIVES: Despite the established efficacy of transcatheter aortic valve replacement for aortic valve replacement, vascular complications remain a major cause of procedural morbidity and mortality. In this study, we evaluate the use of femoral artery cut down with conscious sedation and report outcomes and complications associated with this approach. METHODS: Our study included 282 patients undergoing transcatheter aortic valve replacement with conscious sedation and surgical cut down for femoral access between 2015 and 2017. Data were prospectively recorded in the local institutional database and were retrospectively accessed. Descriptive statistics are presented, and a Kaplan-Meier time-to-event plot was used to estimate 1-year survival. RESULTS: The mean age of the patients was 82.7 ± 7.31 years and consisted of 146 (52%) women. Echocardiographic data demonstrated a severe aortic stenosis with a mean area of 0.65 ± 0.16 cm2 and a mean gradient of 48.9 ± 13.3 mmHg. STS-PROM for the cohort was 7.2%, representing an intermediate risk group. Six (2.2%) patients died within 30 days after transcatheter aortic valve replacement. Major vascular complications occurred in 2 (0.7%) patients and minor vascular complications occurred in 6 (2.2%) patients in our cohort. Wound complications were observed in 2 (0.7%) patients. CONCLUSIONS: We demonstrate that the use of conscious sedation and surgical cut down for femoral arterial access resulted in a major vascular complication rate of less than 1% and low in-hospital mortality rates without any significant increase in wound complications.

Transcatheter Aortic Valve Replacement in Patients With Low-Flow, Low-Gradient Aortic Stenosis: The TOPAS-TAVI Registry.

BACKGROUND: Few data exist on patients with low-flow, low-gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR). Also, very scarce data exist on the usefulness of dobutamine stress echocardiography (DSE) before TAVR in these patients. OBJECTIVES: The authors sought to evaluate clinical outcomes and changes in left ventricular ejection fraction (LVEF) following TAVR in patients with classical LFLG-AS. METHODS: This multicenter registry included 287 patients with LFLG-AS undergoing TAVR. DSE was performed before TAVR in 234 patients and the presence of contractile reserve was defined as an increase of ≥20% in stroke volume. Transthoracic echocardiography was repeated at hospital discharge and at 1-year follow-up. Clinical follow-up was obtained at 1 and 12 months, and yearly thereafter. RESULTS: The median Society of Thoracic Surgeons score of the study population was 7.7% (interquartile range 5.3% to 12.0%), and the mean LVEF and transvalvular gradient were 30.1 ± 9.7% and 25.4 ± 6.6 mm Hg, respectively. The presence of contractile reserve was observed in 45% of patients at DSE. Mortality rates were 3.8%, 20.1%, and 32.3% at 30 days, 1 year, and 2 years, respectively. On multivariable analysis, chronic obstructive pulmonary disease (p = 0.022) and lower hemoglobin values (p < 0.001) were associated with all-cause mortality. Lower hemoglobin values (p = 0.004) and moderate-to-severe aortic regurgitation post-TAVR (p = 0.018) were predictors of the composite of mortality and rehospitalization due to heart failure. LVEF increased by 8.3% (95% confidence interval: 6% to 11%) at 1-year follow-up, and the lack of prior coronary artery bypass graft (p = 0.004), a lower LVEF at baseline (p < 0.001), and a lower stroke volume index at baseline (p = 0.019) were associated with greater increase in LVEF. The absence of contractile reserve at baseline DSE was not associated with any negative effect on clinical outcomes or LVEF changes at follow-up. CONCLUSIONS: TAVR was associated with good periprocedural outcomes in patients with LFLG-AS. However, approximately one-third of LFLG-AS TAVR recipients died at 2-year follow-up, with pulmonary disease, anemia, and residual paravalvular leaks associated with poorer outcomes. LVEF improved following TAVR, but DSE failed to predict clinical outcomes or LVEF changes over time. (Multicenter Prospective Study of Low-Flow Low-Gradient Aortic Stenosis [TOPAS Study]; NCT01835028).

The delayed southern migration of a transcatheter aortic valve.

Transcatheter aortic valve replacement has emerged as a favourable alternative in patients with severe symptomatic aortic stenosis who are at intermediate and/or high risk for open aortic valve replacement. While transcatheter aortic valve replacement has been shown to be a safe alternative to surgical aortic valve replacement in those populations, the procedure is not without risks. Transcatheter heart valve migration can occur, albeit rarely, in an acute, subacute and delayed fashion. This complication can have fatal consequences if not managed appropriately. We describe a patient who underwent a transcatheter aortic valve replacement and had evidence of transcatheter heart valve subacute migration into the left ventricular outflow tract.

Subclavian/Axillary Access for Self-Expanding Transcatheter Aortic Valve Replacement Renders Equivalent Outcomes as Transfemoral.

BACKGROUND: Iliofemoral arterial disease can preclude transfemoral (TF) transcatheter aortic valve replacement (TF-TAVR). Transthoracic access by direct aortic or a transapical approach imparts a greater risk of complications and death than TF access. We hypothesized that subclavian/axillary arterial (SCA) access offers equivalent risks and outcomes as TF access. METHODS: The outcomes of 202 patients from the CoreValve (Medtronic, Minneapolis, MN) United States Pivotal Trial Program treated with SCA access were propensity matched with patients treated with TF access and analyzed. RESULTS: Matching was successful, with no significant baseline differences in the SCA group and the TF group, except the SCA group had more past or present smokers (79.2% vs 61.4%, p < 0.001) and fewer patients with anemia requiring transfusion (18.5% vs 27.5%, p = 0.04). SCA patients experienced a significantly longer time from enrollment to procedure (8.6 ± 19.1 vs 5.3 ± 6.3 days; p = 0.02), likely the result of case planning. Significant differences in procedural outcomes include less post-TAVR balloon dilation (17.9% vs 26.7%, p = 0.03) and more general anesthesia (99.0% vs 89.6%, p < 0.001) for the SCA accesses. There were no differences in procedure time (57.8 ± 45.3 vs 57.5 ± 32.1 min, p = 0.94) or Valve Academic Research Consortium I-defined procedure success between groups (p = 0.89). Event rates at 30 days or 1 year were similar, with a trend toward fewer pacemakers with SCA accesses. CONCLUSIONS: Major morbidity and mortality rates SCA-TAVR are equivalent to TF-TAVR. The SCA should be the preferred secondary access site for TAVR because it offers procedural and clinical outcomes comparable to TF-TAVR and applies to most patients who are not TF candidates.