Association Between Pulmonary Hypertension and Its Effect on 30-Day Mortality, Readmission, and Cost After Transcatheter Aortic Valve Replacement: A Multicenter Study.

Background Pulmonary hypertension (PH) is commonly seen in patients with severe aortic stenosis. Transcatheter aortic valve replacement (TAVR) has been shown to improve PH, however, its impact on clinical outcomes and cost remains unclear. Methods We did a multicenter, retrospective analysis of patients undergoing TAVR in our system between December 2012 to November 2020. The initial sample size was 1356. We excluded patients with prior history of heart failure, with a left ventricular ejection fraction of 40% or less, and patients who had active symptoms of heart failure within two weeks of the procedure. Patients were divided into four groups based on their pulmonary pressures, using right ventricular systolic pressure (RVSP) as a surrogate for PH. Groups included patients with normal pulmonary pressures (<35mmHg), mild (35-45mmHg) moderate (46-60mmHg), and severe PH (>60mmHg). Primary outcomes included 30-day mortality and readmission. Secondary outcomes included length of ICU stay and cost of admission. We used Chi-square and T-tests for demographic analysis of categorical continuous variables respectively. Adjusted regression was used for the reliability of correlation between variables. Multivariate analysis was used for final outcomes. Results Final sample size was 474. Average age was 78.9 years (SD: 8.2, 53% Male). Thirty-one percent (n=150) had normal pulmonary pressures, 33% (n=156) had mild PH, 25% (n=122) had moderate and 10% (n=46) had severe PH. Patients with history of hypertension (p-value<0.001), diabetes (p-value<0.001), chronic lung disease (p-value=0.006) and those on supplemental oxygen (p-value=0.046), had significantly higher proportion of patients with moderate and severe PH. We found significantly higher odds of 30-day mortality in patients with severe PH (OR: 6.77, CI: 1.09-41.98: p-value 0.04) compared with normal or mild PH. There was no significant difference in 30-day readmission (p-value=0.859) between the four groups. Cost did not change with severity of PH (Avg: $261,075: p-value=0.810). Patients with severe PH spent a significantly higher number of hours in ICU, compared with the other three groups (Mean: 18.2, p=value <0.001). Conclusions Severe pulmonary hypertension significantly increased the odds of 30-day mortality and ICU stay in TAVR patients. We did not see any significant difference in 30-day readmission and cost of admission, based on PH severity.

Single Ventricle and Valve-in-Valve, An Impediment or a New Horizon for TAVR?

We present a case of a 30-year-old patient with Fontan physiology and prior bioprosthetic valve replacement who developed severe bioprosthetic aortic valve stenosis. We describe the challenges and planning involved to successfully perform a transcatheter aortic valve-in-valve procedure in this especially complex subset of patients. (Level of Difficulty: Advanced.).

Acute Ostial Right Coronary Artery Occlusion During Valve Deployment of Transcatheter Aortic Valve Replacement Leading to Acute Right Ventricular Failure: A Perfect Storm and Successful Navigation.

Acute coronary obstruction is a relatively rare complication of transcatheter aortic valve replacement (TAVR). Left coronary ostial obstruction is much more common compared to right coronary occlusion due to its relatively lower ostial height from the aortic annulus. We present a case of acute ostial right coronary occlusion immediately upon deployment of a 29-mm Sapien 3 transcatheter aortic valve. The acute right coronary ostial occlusion manifested with ventricular fibrillation, acute right ventricular failure, and right-sided cardiogenic shock. The patient, after undergoing an initial unsuccessful attempt at percutaneous revascularization, was placed on veno-arterial extracorporeal membrane oxygenation (VA-ECMO). This was later transitioned to percutaneous right atrial to pulmonary artery right ventricular support, which led to subsequent recovery.

Meta-Analysis of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Patients With Low Surgical Risk.

Transcatheter aortic valve implantation (TAVI) is the current standard of care for patients with severe aortic stenosis who are at high risk for surgery. However, several recent studies have demonstrated the comparable safety and efficacy of TAVI in low-risk patients as well. We sought to pool the existing data to further assert its comparability. MEDLINE, Cochrane, and Embase databases were evaluated for relevant articles published from January 2005 to June 2019. Studies comparing outcomes of TAVI versus surgical aortic valve replacement in patients who are at low risk for surgery were included. Twelve studies (5 randomized controlled trials and 7 observational studies) totaling 27,956 patients were included. Follow-up ranged from 3 months to 5 years. Short-term all-cause mortality, short-term, and 1-year cardiac mortality were significantly lower in the TAVI group. One-year all-cause mortality, short-term, and 1-year stroke and myocardial infarction were similar in both groups. Rate of acute kidney injury and new-onset atrial fibrillation were lower in the TAVI group, whereas permanent pacemaker implantation and major vascular complications were higher in the TAVI group. Subgroup analysis of randomized controlled trials showed significantly lower 1-year all-cause mortality in the TAVI group. In conclusion, in severe aortic stenosis patients at low surgical risk, TAVI when compared with surgical aortic valve replacement, demonstrated a lower rate of short-term all-cause mortality, short-term, and 1-year cardiac mortality and similar in terms of 1-year all-cause mortality. TAVI is emerging as a safe and efficacious alternative for low surgical risk patients.

Relation of Frailty to Cost for Patients Undergoing Transcatheter Aortic Valve Implantation.

Frailty is associated with significant morbidity and mortality for patients undergoing transcatheter aortic valve implantation (TAVI). In addition to clinical outcomes, cost is an important factor to inform clinical decision-making around TAVI. However, the association of frailty with cost is unknown. This study tested whether frailty was associated with cost for adult patients who underwent TAVI at a moderate-volume single center between December 2012 and April 2018 (n = 431). Frailty was determined from pre-TAVI clinical visits as a composite of 2 markers: 5-meter walk time (abnormal: >6 seconds or unable to perform) and serum albumin (abnormal: <3.5 g/dl). Patients were excluded if missing frailty assessment or covariate data (24). Cost data were derived from financial statements, and assigned at the department-level by charge code. Multivariable regression models were adjusted for age, gender, and procedural co-morbidities. Of 407 patients in the analytical sample (mean age 81 years, 49% female), 74 (18%) were determined to be frail. Adjusted mean total costs were $6,397 higher for frail patients ($78,823 vs $72,425, p = 0.042) compared with nonfrail. Higher total costs were driven by department-level charges associated with longer in-hospital length of stay (7.6 vs 3.3 days, p <0.001): room, physical therapy, pharmacy, laboratory, supply, and imaging services. Providers must address frailty proactively to salvage the benefit associated with TAVI.

Successful minimal approach transcatheter aortic valve replacement in an allograft heart recipient 19 years post transplantation for severe aortic stenosis: A case report.

BACKGROUND: Aortic stenosis is one of the rare valvular complications in a transplanted heart. Over the past 8 years, transcatheter approach for aortic valve replacement (TAVR) has been slowly evolving to be the preferred approach in these patient population when compared to the surgical approach. We report a second case in the United States with successful transfemoral minimal approach with minimal sedation for TAVR in a heart transplant recipient 19 years post transplantation for severe symptomatic calcified aortic stenosis. CASE SUMMARY: We present a case of 73-year-old male who has undergone successful minimal approach transcatheter aortic valve replacement in an allograft heart. Patient had received orthotopic heart transplantation 19 years ago for non-ischemic cardiomyopathy. Follow up transthoracic echocardiograms as per routine protocol did not show any aortic valve disease until 15 years post transplantation. Aortic valve was noted to be mildly sclerotic at that time and gradually progressed to severe symptomatic aortic stenosis over the next 4 years. Patient had complaints of worsening shortness of breath that limited his functional capacity. Overall his post heart transplantation period has been mostly uneventful except for allograft non occlusive vasculopathy and aortic stenosis. His Society of Thoracic Surgery risk score was 12.205% and he was considered to be a high-risk surgical candidate by surgeon. Decision was made to undergo transcatheter aortic valve replacement. CONCLUSION: With the improved survival of these patients, we think it is time to look into pathophysiology of valvular disease in transplant heart recipients. Some other unanswered questions include, underlying donor and recipient risk factors for valvular diseases in heart transplant recipients.

Association Between Body Mass Index and Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement (TAVR) with Edwards SAPIEN™ 3 TAVR Valves: A Single-Center Experience.

BACKGROUND:  Transcatheter aortic valve replacement (TAVR) can be complicated with a high-degree atrioventricular block requiring a permanent pacemaker (PPM) in 5% - 25% of patients. Association between body mass index (BMI) and pacemaker implantation has not been extensively studied. We compared standard BMI classes with the odds of requiring a PPM implantation in patients undergoing TAVR with Edwards SAPIEN™ 3 valves (ESV3) (Edwards Lifesciences, Irvine, CA, USA). METHODS:  Our study involved a single-center retrospective cohort analysis of 449 patients undergoing TAVR from December 2012 to April 2018. First, we excluded patients with a TAVR procedure done with valves other than the ESV3 (127 patients). Second, patients with a prior PPM or an implantable cardioverter-defibrillator (37 patients) were excluded. Finally, patients with an aborted procedure and surgical conversion were excluded (16 patients). The final sample size was 269. The primary outcome was pacemaker implantation. Statistical analysis was done using the Chi-square test, T-test, and adjusted logistic regression. RESULTS:  Of the 269 patients (50.6% males; mean age of 79.5 ± 8.7 years; mean Society of Thoracic Surgeons (STS) score: 6.2), pacemaker implantation was performed in 17 patients (6.3%). Time to pacemaker implantation was 1.3 days. Patients were divided into four categories based on their BMI: as underweight (BMI < 25; 67 patients), normal (BMI: 25 to ≤ 30; 87 patients), overweight (BMI: 30 to ≤ 35; 60 patients), and obese (BMI ≥ 35; 55 patients). Pacemaker implantation was significantly higher in patients with a BMI of > 30 (13 vs. 4, p = 0.037). After logistic linear regression, the odds of getting a PPM after TAVR were significantly higher in patients who were overweight (odds ratio (OR): 12.77, p = 0.024; confidence interval (CI): 1.39 - 17.25) and obese (OR: 15.02, p = 0.036, CI: 1.19 - 19.92). CONCLUSIONS:  Our study demonstrates that increased BMI is a possible risk factor for a high-degree atrioventricular block in patients receiving ESV3.

Conscious Sedation Versus General Anesthesia in Transcatheter Aortic Valve Replacement: A Cost and Outcome Analysis.

Background Transcatheter aortic valve replacement (TAVR) has emerged as an alternative treatment for aortic stenosis in patients who are at moderate to high risk for surgical aortic valve replacement. The use of conscious sedation (CS) as compared with general anesthesia (GA) has shown better clinical outcomes for TAVR patients. Whether CS has any cost-benefit is still unknown. We analyze our local TAVR registry with a focus on the cost comparison between CS and GA for the TAVR population. Methods It is a retrospective chart review of 434 patients who received TAVR at our local center from December 2012 to April 2018. Patients who had their procedure aborted and those requiring a cardiopulmonary bypass or surgical conversion (16 patients) were excluded. The final sample size was 418. Patients were divided into two groups based on whether they received CS or GA. Primary outcomes were intensive care unit (ICU) hours, length of stay in hospital, readmission, or death at 30 days. The secondary outcome was the cost of TAVR admission. The cost was divided into direct and indirect costs. The student's T-test and chi-square tests were used for continuous and categorical variables, respectively. Adjusted logistic regression and multivariate analyses were run for primary and secondary outcomes. Results Of the 418 patients (age: 80.9±8.5, male: 52%) CS was given to 194 patients (46.4%) while GA was given in 224 patients(53.6%). The GA group had comparatively older age (81.8 vs. 80.0; p=0.03) and a higher average Society of Thoracic Surgery (STS) score (8.4 vs 5.7; p<0.001). Patients who received CS had a significantly shorter ICU stay (31.5 vs. 41.6 hours, p<0.001) and total days in the hospital (2.9 vs. 3.8 days, p=0.01). Readmission and mortality at 30 days were not different between the groups. There was no statistical difference in cost between the two groups ($72,809 vs. $71,497: p=0.656). Conclusion Using CS compared with GA improves morbidity for TAVR patients, in the form of ICU stay and the total length of stay in hospital. We did not find a significant difference in the cost of TAVR admission between CS and GA.

Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: A Cost Analysis.

Background Transcatheter aortic valve replacement (TAVR) can be complicated with a complete atrioventricular block requiring permanent pacemaker (PPM) implantation. The cost of index hospitalization for such patients is higher than usual. However, the magnitude of this increased cost is uncertain. We have looked at our five-year TAVR experience to analyze the detailed cost for PPM implantation in TAVR. Methods This study is a retrospective analysis of patients undergoing TAVR at our tertiary care center from December 2012 to April 2018. The initial sample size was 449. We excluded patients with prior PPM or an implantable cardioverter defibrillator (37). Patients who had their procedure aborted or required a cardiopulmonary bypass (16) and those with missing data variables (14) were excluded. The final sample size was 382. The cost for admission was calculated as the US dollars incurred by the hospital. Cohort costs were categorized as a direct cost, which is patient based, and an indirect cost, which represents overhead costs and is independent of patient volume. Patients were divided into two groups based on the placement of PPM after TAVR. Chi-square test, t-test, and logistic linear regression were used for the statistical analysis. Results Of 382 patients, 19 (4.9%) required PPM after TAVR. Baseline variables, including age, gender, and BMI, were not statistically significant. The PPM group had a significantly longer intensive care unit (ICU) stay (48.6 hours vs. 36.7 hours; p<0.001) and total stay in the hospital (4.2 days vs. 3.4 days; p=0.047). PPM implantation after TAVR increased cost on an average of $10,213 more than a typical TAVR admission (p=0.04). The direct cost was also significantly high for the PPM group ($7,087; p=0.02). On detailed analysis, almost all major cost categories showed a higher cost for pacemaker patients when compared with control. Conclusions PPM implantation adds a significant cost burden to TAVR admissions.

Larger Valve Size is Associated with Permanent Pacemaker Implantation in Edwards SAPIEN 3™ Transcatheter Aortic Valves.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) can be complicated with a high-degree atrioventricular (AV) block requiring a permanent pacemaker (PPM) in 5% - 25% of patients. TAVR valve size is a modifiable risk factor for permanent pacemaker implantation (PPI) after TAVR. We studied the association of valve size in PPI with Edwards SAPIEN 3™ (ESV3) (Edwards Lifesciences LLC, Irvine, CA, USA) TAVR valves. METHOD: This is a single-center retrospective cohort analysis of 449 patients undergoing TAVR from December 2012 to April 2018. We excluded patients with TAVR valve types other than the ESV3 (113 patients) and those with prior PPM or implantable cardioverter defibrillator (37 patients). Patients with an aborted procedure and surgical conversion were also excluded (16). Data of 14 patients with missing values for different clinical variables were excluded as well. The final sample size was 269. The primary outcome was PPI. Statistical analysis was done using Chi-square, T-test, and multivariate regression analysis. Multivariate analysis was done for comparison between different clinical variables. RESULTS: Of the 269 patients (50.6% males; mean age of 79.5 ± 8.7 years; mean Society of Thoracic Surgeons (STS) score: 6.2), PPI was seen in 17 patients (6.3%). Time to PPI was 1.3 days. PPI was significantly high in patients with prior conduction defects (p = 0.016). There was a positive relationship between PPI and valve size for ESV3. PPI was seen in eight patients (47%) with 29 mm valves, six patients (35%) with 26 mm valves, three patients (17%) with 23 mm valves, and none with 20 mm valves. When taken as a reference, 23 mm valves had a significantly lower PPI compared with 29 mm valves (eight versus three; p = 0.04). CONCLUSION: Larger valve size is a possible risk factor for a high-degree AV in patients receiving ESV3.

Quadricuspid Aortic Valve Stenosis: Expanding Our Experience in Transcatheter Aortic Valve Implantation.

To our knowledge, this is the first documented case of successful TAVI for severe quadricuspid aortic valve (QAV) stenosis performed in the U.S. and the first documented Sapien 3 valve implantation in a severely stenotic QAV.

Transcatheter aortic valve replacement in membranous interventricular septum aneurysm with left ventricular outflow tract extension.

We report a challenging case of a 81-year-old male with history of severe calcific aortic valve stenosis and aneurysmal membranous interventricular septum. The presence of anomalies in the sub-annular area can lead to valve malpositioning and its consequences. transcatheter aortic valve implantation (TAVR) in patients with aneurysm of the perimembranous interventricular septum extending into the left ventricular outflow tract has not been previously reported. This case describes a successful transfemoral TAVR with an Edwards SAPIEN XT valve (Edwards Lifesciences, Irvine, CA, United States) with such anomaly.