Prognostic Value of Red Blood Cell Distribution Width in Transcatheter Aortic Valve Replacement Patients.

OBJECTIVE: Elevated red blood cell distribution width (RDW) level has been shown to be associated with poor outcomes in patients with cardiovascular disease. Limited data are available regarding the prognostic value of RDW in transcatheter aortic valve replacement (TAVR) patients. Therefore, we aimed to investigate the impact of RDW variation on outcomes of TAVR patients. METHODS: From March 20, 2012, to February 20, 2020, the pre-TAVR RDW levels of 1,163 consecutive TAVR patients were examined. Receiver operating curves were set to define the most accurate cut-point, which was subsequently validated in our validation set. Associations of RDW levels with early and long-term outcomes were investigated. RESULTS: A total of 988 patients were eligible for the analysis. Patients with 30-day, 1-year, and 7-year mortality had significantly higher pre-TAVR RDW levels (15.8% [12.9-19.1] vs 14.7% [11.6-26.3], P = 0.01; 16% [12.3-26.3] vs 14.7% [11.6-24.3], P < 0.001; 15.6% [12.3-26.3] vs 14.6% [11.6-24.3], P < 0.001, respectively). A RDW of 14.5% was found as the most sensitive and specific cut-point for mortality at 1 and 7 years (HR = 2.6, 95% CI: 1.6-4.2, P < 0.001; HR = 1.8, 95% CI: 1.3-2.4, P < 0.001), with mortality of 22% versus 10% at 1 year (P < 0.001) and 37% versus 27% at 7 years (P < 0.001) in patients with RDW ≥14.5% versus those with RDW <14.5%. CONCLUSIONS: RDW is an important prognostic factor in TAVR patients. A RDW level higher than 14.5% is significantly associated with post-TAVR early and late mortality. RDW levels should be incorporated into current risk assessment models as an additional variable to predict post-TAVR outcomes.

Percutaneous Inferior Vena Cava Valve Implantation May Improve Tricuspid Valve Regurgitation and Cardiac Output: Lessons Learned.

Tricuspid valve regurgitation (TR) can be associated with poor prognosis. Transcatheter valve technology was adopted to treat the upstream effects of severe TR by placing a transcatheter valve in the inferior vena cava (IVC). In this study, we report off-label transcatheter valve implantation into the stented IVC in patients with severe TR for compassionate use. From September 2018 to February 2020, 6 inoperable patients with severe TR who failed medical treatment underwent percutaneous caval valve implantation (CAVI). Severity of TR was confirmed by intraoperative transesophageal echocardiography. Z-stents (Cook, Inc., Bloomington, IN, USA) were placed in the proximal IVC, and then a transcatheter valve was deployed in the suprahepatic cava without rapid pacing. Six patients, 2 females and 4 males, with a mean ± SD age of 74.7 ± 8.0 years were included. The procedure was successfully performed in all 6 patients (100%) employing a 29-mm SAPIEN 3 valve (Edwards Lifesciences, Irvine, CA, USA) with supranominal volume. No procedural complication was detected. At 30 days, TR improved from severe to trace in 1 patient, to mild-moderate in 3 patients, and 2 patients remained with severe TR. Among patients with improved TR, left ventricular ejection fraction increased from 47.5% ± 18.5% to 55% ± 20.4% (P = 0.014). No patient had readmission at 30 days. Four patients needed rehospitalization within 6 months. Percutaneous CAVI is feasible and can be considered as a short-term palliative measure in patients with severe TR. CAVI can improve TR and potentially improve cardiac output in selected patients.

Transvalvular Gradients for Balloon-Expandable and Self-Expanding Valves.

Self-expanding valves have been associated with superior hemodynamics versus balloon-expandable valves. Our aim was to compare invasive gradients between valve types for similarly sized valves. Patients who underwent transcatheter aortic valve replacement (TAVR) at the Malcom Randall Veterans Affairs Medical Center and the Bern University Hospital were considered for this analysis. From 1623 subjects who underwent TAVR, a total of 566 had available invasive hemodynamic data. After applying exclusion criteria, we included 499 for analysis. With immediate invasive hemodynamic assessment, balloon- expandable valves were associated with similar/marginally lower transvalvular gradients versus self-expanding valves. With postoperative echocardiography within 24 hours, self-expanding valves were associated with lower Doppler gradients versus balloon-expandable valves for all size categories.

The relationship between baseline diastolic dysfunction and postimplantation invasive hemodynamics with transcatheter aortic valve replacement.

BACKGROUND: Abnormal invasive hemodynamics after transcatheter aortic valve replacement (TAVR) is associated with poor survival; however, the mechanism is unknown. HYPOTHESIS: Diastolic dysfunction will modify the association between invasive hemodynamics postTAVR and mortality. METHODS: Patients with echocardiographic assessment of diastolic function and postTAVR invasive hemodynamic assessment were eligible for the present analysis. Diastology was classified as normal or abnormal (Stages 1 to 3). The aorto-ventricular index (AVi) was calculated as the difference between the aortic diastolic and the left ventricular end-diastolic pressure divided by the heart rate. AVi was categorized as abnormal (AVi < 0.5 mmHg/beats per minute) or normal (≥ 0.5 mmHg/beats per minute). RESULTS: From 1339 TAVR patients, 390 were included in the final analysis. The mean follow-up was 3.3 ± 1.7 years. Diastolic dysfunction was present in 70.9% of the abnormal vs 55.1% of the normal AVi group (P < .001). All-cause mortality was 46% in the abnormal vs 31% in the normal AVi group (P < .001). Adjusted hazard ratio (HR) for AVi < 0.5 mmHg/beats per minute vs AVi ≥0.5 mmHg/beats per minute for intermediate-term mortality was (HR = 1.5, 95% confidence interval [CI] 1.1 to 2.1, P = .017). This association was the same among those with normal diastolic function and those with diastolic dysfunction (P for interaction = .35). CONCLUSION: Diastolic dysfunction is prevalent among TAVR patients. Low AVi is an independent predictor for poor intermediate-term survival, irrespective of co-morbid diastolic dysfunction.

Predictors of ventricular pacing burden after permanent pacemaker implantation following transcatheter aortic valve replacement.

BACKGROUND: In the era of an expanding use of transcatheter aortic valve replacement (TAVR), conduction disturbances and the requirement for permanent pacemaker (PPM) implantation remains a clinical concern. HYPOTHESIS: Using a single-center experience, we sought to identify predictors of ventricular pacing burden after TAVR in patients who required PPM implantation. METHODS: We conducted a retrospective study of 359 consecutive patients with symptomatic severe aortic valve stenosis who underwent TAVR at our institution between September 2013 and July 2019. Thirty patients (8.4%) required a PPM within 30 days after TAVR. Pre and post-TAVR electrocardiograms, pre-TAVR echocardiograms and computed tomography (CT), TAVR procedural details and post-TAVR device interrogation records at 1, 3, and 6 months were reviewed. RESULTS: Mean percentage of ventricular pacing (VP%) at 1, 3, and 6 months was 58%, 59%, and 56% respectively. Using univariate logistic regression analysis, patients who had low VP% < 5% at 6 months were more likely to have a prosthesis/echocardiography-derived left ventricular outflow tract (LVOT) diameter ratio < 1.3 (OR 7.00, P-value .048), prosthesis/CT-derived aortic annulus diameter ratio < 1.02 (OR 7.11, P-value .047), post-TAVR new-onset LBBB (OR 16.80, P-value .019), time to PPM implantation greater than 2 days post-TAVR (OR 9.38, P-value .026) and pre-TAVR use of a beta blocker (OR 9.40, P-value .026). CONCLUSIONS: In patients who required a PPM implantation post-TAVR, a lower TAVR prosthesis/LVOT or aortic annulus diameter ratio, post-TAVR new-onset LBBB and later time of PPM implantation showed a trend toward predicting a low VP% at 6 months.

Outcomes of Florida Sleeve Procedure in Patients with Bicuspid Versus Tricuspid Aortic Valve.

OBJECTIVE: Outcomes of the Florida Sleeve (FS) procedure in patients with bicuspid aortic valve (BAV) have not been reported before. We compared outcomes of the FS procedure between patients with BAV and those with tricuspid aortic valve (TAV). METHODS: From May 1, 2002 to January 1, 2016, 177 patients including 18 BAV and 159 TAV underwent the FS procedure. Baseline characteristics, perioperative outcomes, and echocardiographic measurements were compared between the 2 groups. Kaplan-Meier and life-table analyses were used to evaluate survival and freedom from reintervention rates. RESULTS: Mean ± standard deviation age and aortic root diameter were comparable in BAV and TAV groups, 47.83 ± 11.19 versus 49.59 ± 15.79 years (P = 0.55) and 56.57 ± 6.18 versus 55.17 ± 8.84 mm (P = 0.46), respectively. The 30-day mortality and stroke rates were zero in the BAV group and 1.88% (n = 3) in the TAV group (P = 1.00). One patient (5.55%) in the BAV group and 8 (5.03%) patients in the TAV group needed permanent pacemaker implantation (P = 0.62). Freedom from reoperation was 93% in the BAV group and 99% in the TAV group at 8 years (P = 0.041). Patient survival rate was 100% in the BAV group and 91% in the TAV group at 8 years (P = 0.42). Freedom from aortic insufficiency greater than mild was 93% in the BAV group and 96.5% in the TAV group at 5 years (P = 0.61). CONCLUSIONS: This is the first study reporting outcomes of the FS procedure in patients with BAV. This technique is feasible, and the results appear to be durable when compared to patients with TAV.

Relationship between Invasive and Echocardiographic Transvalvular Gradients after Transcatheter Aortic Valve Replacement.

INTRODUCTION: Lower transcatheter aortic valve replacement (TAVR) pressure gradients have been reported after implantation of self-expanding valves compared with balloon-expandable valves; however, there is a paucity of data on the relationship between invasively measured transvalvular pressure gradients and Doppler-derived measurements. METHODS: From September 2013 to September 2018, patients with native aortic valve stenosis who had both intraoperative invasive and postoperative echocardiography transvalvular pressure gradients were included for analysis. We used parametric and nonparametric statistics to compare aortic gradients within and between groups. RESULTS: Of 171 patients, 152 (88.9%) patients had TAVR with a balloon-expandable valve and 19 (11.1%) with a self-expanding valve. Among all patients, the invasive aortic gradient was 7.8 ± 3.2 mmHg and the Doppler-derived aortic gradient was 11.0 ± 4.5 mmHg (p < 0.001). Among those who received a balloon-expandable valve, the invasive aortic gradient was 7.5 ± 3 mmHg and the Doppler aortic gradient was 11.4 ± 4.5 mmHg (p < 0.001). In contrast, among patients who received a self-expanding valve, the invasive aortic gradient was 10.3 ± 3.4 mmHg and the Doppler aortic gradient was 8.5 ± 4.6 mmHg (p = 0.18). CONCLUSIONS: Balloon-expandable valves were associated with lower invasive measurements versus post-TAVR Doppler gradients, while results were inconclusive regarding self-expanding valves.

The Florida Sleeve Procedure Is Durable and Improves Aortic Valve Function.

BACKGROUND: The Florida (FL) Sleeve procedure was introduced as a simplified approach for valve-sparing correction of functional Type I aortic insufficiency (AI) associated with aortic root aneurysms. In this study, short- and long-term outcomes after the FL Sleeve procedure were investigated. METHODS: From May 2002 to January 2016, 177 patients underwent the FL Sleeve procedure. Left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter, left ventricular ejection fraction, and degree of AI (none = 0, minimal = 1, mild = 2, moderate = 3, severe = 4) were evaluated by echocardiography. RESULTS: Mean ± standard deviation of age was 49.41 ± 15.37 years. Survival rate was 98% at 1 year, 97% at 5 years, and 93% at 8 years. Freedom from reoperation was 99% at 1 year and 98% at 2 to 8 years. Three patients (1.69%) died during hospitalization. Three patients (1.69%) developed periprocedural stroke. Postoperative follow-up echocardiography was available in 140 patients at 30 days, and 31 patients at 5 years. AI grade significantly improved from baseline at 30 days (2.18 ± 1.26 vs. 1.1 ± 0.93, p < 0.001) and at 5 years (2.0 ± 1.23 vs. 1.45 ± 0.88, p = 0.04). Preoperative mean LVEDD significantly decreased from 52.20 ± 6.73 to 46.87 ± 8.40 (p < 0.001) at 30 days, and from 53.22 ± 7.07 to 46.61 ± 10.51 (p = 0.01) at 5 years. CONCLUSIONS: The FL Sleeve procedure is a safe, effective, and durable treatment of aortic root aneurysm and Type I AI. Long-term survival and freedom from reoperation rates are encouraging.

Minimally invasive thoracoscopic surgery is an effective approach for treating inappropriate sinus tachycardia.

INTRODUCTION: Inappropriate sinus tachycardia (IST) is characterized by increased heart rate out of proportion to normal physiologic demand. IST ablation is challenging for the electrophysiology community due to the epicardial location of the sinus node and the risk of phrenic nerve (PN) injury during catheter ablation. In this study, we investigated the safety and efficacy of a minimally invasive thoracoscopic surgery for elimination of IST. METHODS: Patients with IST who failed medical therapy or endocardial ablation underwent minimally invasive thoracoscopic epicardial ablation. Epicardial activation mapping was performed to identify the earliest activation site and any possible migration of earliest activation along the lateral right atrium. The PN in each patient was protected by a pericardial retraction suture. RESULTS: From 1 January 2000 to 15 June 2018, 10 patients (eight females and two males) underwent minimally invasive thoracoscopic IST ablation. Mean age of the patients was 36.7 ± 12.5 years. Mean baseline sinus rate was 113.8 ± 21.8 beats per minute. After surgery, the mean heart rate significantly decreased to 79.8 ± 8.2 at postoperative day 1 and to 75.8 ± 8.1 at day 30 (both P < .001). No in-hospital death, stroke, or PN injury occurred. One patient required reintubation, one patient developed postoperative pericarditis, and another patient had a pulmonary embolus. Median follow-up was 6 months (range, 1-50). Freedom from reintervention was 88% at 6 months. CONCLUSION: Minimally invasive thoracoscopic ablation for IST is a safe and effective approach that preserves the phrenic nerve. Due to the possibility of IST activation site migration, continued follow-up after surgery is required.

Impact of Valve Size on Prosthesis-Patient Mismatch and Aortic Valve Gradient After Transcatheter versus Surgical Aortic Valve Replacement.

OBJECTIVE: Limited data is available about the effect of implanted valve size on prosthesis-patient mismatch (PPM) incidence and aortic gradient (AG) after transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). We compared PPM incidence and postprocedural AG between TAVR and SAVR patients considering the impact of implanted valve size. METHODS: From March 20, 2012, to September 30, 2015, 563 consecutive patients underwent TAVR (n = 419) or isolated SAVR (n = 144). Postprocedural transthoracic echocardiography was obtained within 30 days; AG, effective orifice area (EOA), and EOA index were calculated. RESULTS: A total of 381 patients in TAVR group and 82 patients in SAVR group were included. Mean preoperative AG and mean aortic valve area were not significantly different between the 2 groups. Postprocedural AG was significantly lower in TAVR than SAVR group, 7.74 ± 5.39 versus 14.27 ± 8.16 (P < 0.001). Between patients who had TAVR and SAVR with a valve size ≤23 mm, SAVR patients were 3 times more likely to have greater than mild AG after the procedure, OR: 3.1 (95% CI, 1.1 to 8.9) (P < 0.001). PPM incidence was significantly higher in SAVR group than TAVR group, 44 (53.7%) versus 112 (29.4%), OR = 2.8 (95% CI, 1.7 to 4.5) (P < 0.001). The PPM incidence was also higher in SAVR group than TAVR group among those who had the procedures with a valve size ≤23 mm, 35 (64.8%) versus 56 (47.9%), OR = 2 (95% CI, 1.1 to 3.9) (P = 0.048). Postprocedural outcomes were comparable between the 2 groups. CONCLUSIONS: In comparison to SAVR, TAVR is associated with less PPM and lower AG, especially in patients receiving a valve size ≤23 mm.

Left Ventricular Diastolic Dysfunction and Transcatheter Aortic Valve Replacement Outcomes: A Review.

Aortic stenosis (AS) is the most common valvular disease that can lead to increased afterload, left ventricular (LV) remodeling, and myocardial fibrosis. We reviewed the literature addressing the impact of transcatheter aortic valve replacement (TAVR) on LV remodeling and patients' outcomes by elimination of AS-related high afterload. TAVR reduces afterload and improves LV remodeling recovery. However, myocardial fibrosis may not completely reverse after the TAVR. The LV diastolic dysfunction (LVDD) induced by AS is an independent predictor of post-TAVR mortality, and mortality increases with severity of LVDD. The impact of diastolic dysfunction on patient outcomes emerges at 30 days but continues to persist during mid-term follow-up. Based on severity of the baseline LVDD, some patients may tolerate post-TAVR aortic regurgitation (AR), but even minimal post-TAVR AR in patients with severe baseline LVDD can have an additive negative impact on survival. It is crucial to consider TAVR prior to development of advanced LVDD. Appropriate device selection and deployment technique are important in improvement of TAVR outcomes via elimination of AR.

Outcomes of Direct Transcatheter Aortic Valve Replacement Without Balloon Aortic Valvuloplasty Using a New Generation Valve.

PURPOSE: We investigated the outcomes of patients who underwent Transcatheter Aortic Valve Replacement (TAVR) with and without Balloon Aortic Valvuloplasty (BAV) using the SAPIEN 3 (S3) valve. METHODS: All patients who underwent TAVR using S3 valve were included. The primary outcomes were the incidence of stroke and significant paravalvular leak (PVL). Secondary outcomes were the incidence of mortality, balloon post dilation, and need for permanent pacemaker. RESULTS: From July-2014 to April-2018, 34 (9%) patients underwent BAV prior to TAVR and 344 (91%) patients underwent direct TAVR without BAV using the S3 valve. The Society of Thoracic Surgeons (STS) risk score was similar between two groups; 5.8 ±â€¯3.5 in no BAV group and 5.4 ±â€¯3.3 in BAV group, p = 0.53. After TAVR, 6 (1.7%) patients in no BAV group but no patient in BAV group developed stroke (p = 1.0). No patient had severe PVL and only 5 patients (1.3%) had moderate PVL at 30-day; 4 (1.2%) in no BAV group and 1 (2.9%) in BAV group (p = 0.38). Forty-six patients (13.4%) in the no BAV group and 4 (11.8%) patients in the BAV group needed balloon post dilation (p = 1.0). Six (1.6%) patients died during hospitalization, all in the no BAV group (p = 1.0). Forty-five (11.9%) patients needed new pacemaker implantation; 44 (12.8%) patients in no BAV group and 1 (2.9%) patient in BAV group (p = 0.1). Two-year survival rate was 85% in no BAV group and 84% in BAV group (p = 0.46). CONCLUSIONS: TAVR using S3 valves is associated with very low rates of post-TAVR stroke and significant PVL. Outcomes of direct TAVR are similar to the outcomes of TAVR with BAV, without an increased rate of stroke, significant PVL, or balloon post dilation.

Neurologic Outcomes in Aortic Arch Repair With Frozen Elephant Trunk Versus 2-Stage Hybrid Repair.

BACKGROUND: We compared outcomes of single-stage hybrid aortic arch replacement (frozen elephant trunk) versus 2-stage hybrid repairs with primary open arch procedures followed by thoracic endovascular stenting. METHODS: This study reports a single-center retrospective review (2003 to 2016) of 118 patients undergoing hybrid repair of the aortic arch including 48 single-stage repairs versus 70 two-stage repairs. RESULTS: Single-stage repair was performed in 48 patients, including 31 (64.6%) men and 17 (35.4%) women with a mean age of 64 ± 11 years and a 2-stage procedure was performed in 70 patients, including 42 (60%) men and 28 (40%) women with a mean age of 65.67 ± 13.3 years (p = 0.46). More emergent single-stage procedures were performed in 23 of 48 (47.9%) patients versus 2-stage procedures in 8 of 70 (11.43%) patients (p < 0.001). Between the single- and 2-stage groups, there was no difference in stroke (6.25% [3 of 48] versus 14.28% [10 of 70]; p = 0.23), spinal cord ischemia (4.16% [2 of 48] versus 5.7% [4 of 70]; p = 1.0), or 30-day mortality rate: 8 of 48 (16.7%) patients versus a combined 30-day mortality rate of the 2-stage procedure of 14.8% (4 of 70 [5.7%] at the first stage and 5 of 55 [9.1%] at the second stage; p = 0.56), respectively. After exclusion of the 30-day mortality, midterm survival was 86% at 1 to 2 years for single-stage patients versus 80% at 1 year and 46% at 2 years for the 2-stage patients (p = 0.0019). CONCLUSIONS: Both single-stage and 2-stage hybrid arch replacements are effective approaches for treating complex aortic arch diseases. Early deaths and neurological outcomes in the single-stage group are comparable to those in the combined 2-stage group. Furthermore, in this series, patients who had a single-stage hybrid procedure had a higher survival rate at 2 years.

Trend and Outcomes of Direct Transcatheter Aortic Valve Replacement from a Single-Center Experience.

INTRODUCTION: When transcatheter aortic valve replacement (TAVR) was introduced, pre-implantation balloon aortic valvuloplasty (BAV) was a routine part of the procedure. Smaller device profiles have resulted in selective use of BAV; however, there is a paucity of data about the trend in use of direct TAVR and the safety of this strategy. METHODS: All patients who underwent TAVR at a Veterans Affairs Medical Center from September 2013 to November 2016 were included in this retrospective analysis. We reviewed angiography films and verified with procedure reports to assess if direct TAVR was performed. Troponin T was assessed within 72 h after the TAVR. Multivariate analysis examined the association between direct TAVR and periprocedural myocardial infarction (MI) or 1-year mortality. RESULTS: Overall, 207 patients were available for analysis. The mean follow-up was 13.3 months. A balloon-expandable valve was used 93.2% of the time, and 35.3% of patients were treated with conscious sedation. Periprocedural MI or 1-year mortality occurred in 12.5% of the direct TAVR group versus 18.3% of the pre-implantation BAV group (p = 0.30). After controlling for potential confounding variables, direct TAVR was not associated with periprocedural MI or 1-year mortality. CONCLUSIONS: Direct TAVR appears to be safe and is not associated with periprocedural MI or 1-year mortality. With current generation devices, this strategy can be considered for most patients undergoing TAVR.

Early and midterm outcomes of transcatheter aortic valve replacement in patients with bicuspid aortic valves.

BACKGROUND: Bicuspid aortic valve (BAV) stenosis has been considered a relative contraindication to transcatheter aortic valve replacement (TAVR). We compared the outcomes of TAVR in patients with BAV stenosis versus patients with trileaflet aortic valve stenosis. METHODS: From March 2012 to September 2017, 727 patients underwent TAVR. Thirty-two patients with BAV were included in this study and compared to 96 patients with comparable risk factors (1:3) with a trileaflet aortic valve (TAV). Transesophageal echocardiography was used to estimate post-TAVR degree of paravalvular leak (PVL). RESULTS: Mean ± standard deviation Society of Thoracic Surgeons risk was 6.01 ± 3.42 in the BAV group and 6.08 ± 3.76 in the TAV group (P = 0.92). Thirty-day mortality was 4.2% (N = 4) in the TAV group and 6.25% (N = 2) in the BAV group (P = 0.63). Three (3.1%) patients in the TAV group and two (6.25%) patients in the BAV group developed a post operative stroke (P = 0.59). Following TAVR, mean aortic valve gradient significantly decreased in both TAV (42.56 ± 14.93 vs 9.27 ± 5.57, P < 0.001) and BAV (44.12 ± 11.82 vs 9.03 ± 7.29, P < 0.001) groups. No patient had a severe PVL after TAVR, and only two (2.08%) patients in the TAV group and one (3.12%) patient in the BAV group had moderate PVL (P = 1.0). Patient survival rate at 1 and 2 years was 86% in the BAV group and 90% at 1 and 2 years in the TAV group (P = 0.74). CONCLUSIONS: TAVR in BAV disease is feasible with favorable valve performance. Immediate and mid-term outcomes of TAVR in patients with BAV are comparable to those with TAV.