Effect of Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement on All-Cause Mortality in Patients With Aortic Stenosis: A Randomized Clinical Trial.

Importance: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement and is the treatment of choice for patients at high operative risk. The role of TAVI in patients at lower risk is unclear. Objective: To determine whether TAVI is noninferior to surgery in patients at moderately increased operative risk. Design, Setting, and Participants: In this randomized clinical trial conducted at 34 UK centers, 913 patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014 and April 2018 and followed up through April 2019. Interventions: TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgical aortic valve replacement (surgery; n = 455). Main Outcomes and Measures: The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the 1-sided 97.5% CI for the absolute between-group difference in mortality. There were 36 secondary outcomes (30 reported herein), including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation. Results: Among 913 patients randomized (median age, 81 years [IQR, 78 to 84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0% to 3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of -2.0% (1-sided 97.5% CI, -∞ to 1.2%; P < .001 for noninferiority). Of 30 prespecified secondary outcomes reported herein, 24 showed no significant difference at 1 year. TAVI was associated with significantly shorter postprocedural hospitalization (median of 3 days [IQR, 2 to 5 days] vs 8 days [IQR, 6 to 13 days] in the surgery group). At 1 year, there were significantly fewer major bleeding events after TAVI compared with surgery (7.2% vs 20.2%, respectively; adjusted hazard ratio [HR], 0.33 [95% CI, 0.24 to 0.45]) but significantly more vascular complications (10.3% vs 2.4%; adjusted HR, 4.42 [95% CI, 2.54 to 7.71]), conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%; adjusted HR, 2.05 [95% CI, 1.43 to 2.94]), and mild (38.3% vs 11.7%) or moderate (2.3% vs 0.6%) aortic regurgitation (adjusted odds ratio for mild, moderate, or severe [no instance of severe reported] aortic regurgitation combined vs none, 4.89 [95% CI, 3.08 to 7.75]). Conclusions and Relevance: Among patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery with respect to all-cause mortality at 1 year. Trial Registration: isrctn.com Identifier: ISRCTN57819173.

Initial experience of a self-expanding transcatheter aortic valve with an outer pericardial wrap: The United Kingdom and Ireland Implanters' registry.

OBJECTIVES: The United Kingdom and Ireland Implanters' registry is a multicenter registry which reports on real-world experience with new transcatheter heart valves. BACKGROUND: The Evolut PRO (Medtronic, Minneapolis, MN) transcatheter aortic valve is a self-expanding transcatheter aortic valve with an outer pericardial wrap, designed to minimize paravalvular regurgitation. METHODS: Between July 2017 and December 2018, clinical, procedural, and 30-day outcome data were prospectively collected from all patients receiving the Evolut PRO valve across nine participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium-2 (VARC-2)-defined endpoint of device success. The primary safety outcome was the VARC-2-defined composite endpoint of early safety at 30 days. RESULTS: A total of 317 patients underwent implantation. Mean age was 81.8 ± 6.4 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.5 ± 1.8%. Iliofemoral access was used in 99.1% of patients. Device success was 91.2%. Mean gradient was 7.6 ± 4.7 mmHg and effective orifice area 1.9 ± 0.7 cm2 . The incidence of moderate paravalvular regurgitation was 1.7% and there was no severe paravalvular regurgitation. A new permanent pacemaker was implanted in 17.8% of patients without a pacemaker at baseline. Early safety was demonstrated in 92.7%. At 30 days, all-cause mortality was 0.6%, stroke 3.8%, and major vascular complication 2.8%. CONCLUSIONS: Real-world experience of the Evolut PRO transcatheter aortic valve demonstrated favorable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.

Management of Postprocedural Conduction Disturbances Using a Prespecified Algorithm in the Optimize PRO Study.

Background: Lack of standardization in posttranscatheter aortic valve replacement (TAVR) conduction disturbance (CD) identification and treatment may affect permanent pacemaker implantation (PPI) rates and clinical outcomes. The safety and efficacy of a standardized TAVR CD algorithm has not been analyzed. This study analyzes the Optimize PRO post-TAVR CD management algorithm with Evolut PRO/PRO+ valves. Methods: Optimize PRO is a prospective, postmarket study implementing 2 strategies to reduce pacemaker rates: TAVR with cusp overlap technique and a post-TAVR CD algorithm. The 2-hour postprocedural electrocardiogram (ECG) stratified patients to early discharge in the absence of new ECG changes or to CD algorithms for (1) ECG changes with preexisting right or left bundle branch block (LBBB), interventricular conduction delay or first-degree atrioventricular block, (2) new LBBB, or (3) high-degree atrioventricular block (HAVB). Results: The interim analysis of the CD cohort consisted of 125/400 TAVR recipients. In the CD cohort, the 30-day new PPI rate was higher (28.1% vs 1.5%; P <.001), and 60 (48%) patients were discharged with a 30-day continuous ECG monitor. At 30 days, 90% of patients discharged with a monitor did not require PPI. Clinical outcomes, including mortality, stroke, bleeding, and reintervention, were similar in patients with and without CDs. No patient experienced sudden cardiac death. Conclusions: Effective management of CDs using a standard algorithm following Evolut TAVR provides similar 30-day safety outcomes to patients without CDs who undergo routine next day discharge. The CD algorithm may provide an effective strategy to recognize arrhythmias early, improve PPI utilization, and facilitate safe monitoring of patients after discharge.

Clinical Impact of Standardized TAVR Technique and Care Pathway: Insights From the Optimize PRO Study.

BACKGROUND: Procedural success and clinical outcomes after transcatheter aortic valve replacement (TAVR) have improved, but residual aortic regurgitation (AR) and new permanent pacemaker implantation (PPI) rates remain variable because of a lack of uniform periprocedural management and implantation. OBJECTIVES: The Optimize PRO study evaluates valve performance and procedural outcomes using an "optimized" TAVR care pathway and the cusp overlap technique (COT) in patients receiving the Evolut PRO/PRO+ (Medtronic) self-expanding valves. METHODS: Optimize PRO, a nonrandomized, prospective, postmarket study conducted in the United States, Canada, Europe, Middle East, and Australia, is enrolling patients with severe symptomatic aortic stenosis and no pre-existing pacemaker. Sites follow a standardized TAVR care pathway, including early discharge and a conduction disturbance management algorithm, and transfemoral deployment using the COT. RESULTS: A total of 400 attempted implants from the United States and Canada comprised the main cohort of this second interim analysis. The mean age was 78.7 ± 6.6 years, and the mean Society of Thoracic Surgeons predictive risk of mortality was 3.0 ± 2.4. The median length of stay was 1 day. There were no instances of moderate or severe AR at discharge. At 30 days, all-cause mortality or stroke was 3.8%, all-cause mortality was 0.8%, disabling stroke was 0.7%, hospital readmission was 10.1%, and cardiovascular rehospitalization was 6.1%. The new PPI rate was 9.8%, 5.8% with 4-step COT compliance. In the multivariable model, right bundle branch block and the depth of the implant increased the risk of PPI, whereas using the 4-step COT lowered 30-day PPI. CONCLUSIONS: The use of the TAVR care pathway and COT resulted in favorable clinical outcomes with no moderate or severe AR and low PPI rates at 30 days while facilitating early discharge and reproducible outcomes across various sites and operators. (Optimize PRO; NCT04091048).

Chest Pain Post-Transcatheter Aortic Valve Implantation: Don't Forget the Uncommon Complication.

Transesophageal echocardiography guides a range of structural heart disease interventions, especially in older adult and frail patients who are deemed not suitable to undergo surgical repair. Although rare, transesophageal echocardiography can be associated with esophageal trauma, including perforation. Treating physicians should be cognizant of such a complication. (Level of Difficulty: Intermediate.).

Transcatheter Aortic Valve Replacement via the Right Subclavian Artery Approach: A Case Series.

The right subclavian artery (RSA) approach is an infrequently used alternative-access method for transcatheter aortic valve replacement (TAVR), which may be considered when transfemoral and left subclavian artery (LSA) access routes are contraindicated. The double arterial bend encountered along the course of the RSA to the aortic root makes advancement of the TAVR delivery system more challenging, but can be overcome using a steerable delivery system over an ultra-stiff guidewire. We report 5 cases from our institution of TAVRs performed via the RSA approach in patients with severe aortic stenosis that were unsuitable for transfemoral or LSA access. The procedures were performed under general anesthesia, using a 5-cm infraclavicular incision. In each case, an Edwards Commander Delivery System was advanced through an eSheath over an Innowi guidewire, and an Edwards SAPIEN 3 valve was successfully deployed. The mean fluoroscopy time was 19.5 ± 3.8 minutes. No aortic regurgitation (AR) was present postprocedure for 4 out of 5 cases, and 1 had mild to moderate AR. The length of hospital stay was 2 to 3 days for 4 patients. All patients had an excellent outcome at 12 months post-procedure. The RSA approach is a safe and feasible access method for TAVR, and we recommend that it be considered as the next best access method if transfemoral and LSA approaches are unsuitable.

Longitudinal deformation bench testing using a coronary artery model: a new standard?

Objectives: To compare susceptibility of five different stent platforms with longitudinal stent deformation (LSD) using a clinically relevant bench testing model simulating both short and long malapposed lengths. Background: Recent data suggest that design modifications to the Promus Element stent which led to the Promus Premier stent has reduced susceptibility to LSD. However, susceptibility to LSD at long malapposed lengths has not been tested. Furthermore, the mechanisms behind susceptibility to LSD are as yet unclear. Methods: The Omega, Integrity, Multilink 8, Biomatrixand Promus Premier stent platforms were tested. The Omega, Integrity and Multilink 8 platforms were used in place of their drug-eluting equivalents. 3.5 mm stents were deployed in a stepped tube with the distal portion fixed and the proximal test section exposed. The force required to compress stents by a fixed distance at different exposed lengths was compared. Symmetrical and point loading were used. Results: The Promus Premier was longitudinally as strong as Multilink and Integrity at a short exposed length (4 mm) but weaker, in between Omega and the other platforms, at longer exposed lengths (12 mm). As previously noted, the Omega (Promus Element) platform was significantly weaker than the other stents and Biomatrix was the strongest stent. Conclusion: Susceptibility to LSD varies depending on length of malapposed segment when tested using a clinically relevant model as in this study. The mechanisms behind the susceptibility are likely multifactorial, including connector number, strut thickness, connector alignment and ring orientation but remain to be elucidated.

Diagnosis of lower-limb deep venous thrombosis: a prospective blinded study of magnetic resonance direct thrombus imaging.

BACKGROUND: Current magnetic resonance techniques generate high signal from venous blood and show thrombi as filling defects. Magnetic resonance direct thrombus imaging (MRDTI) directly visualizes acute thrombus. OBJECTIVE: To determine the accuracy of MRDTI for diagnosis of acute symptomatic deep venous thrombosis (DVT) below and above the knee. DESIGN: Prospective, blinded study. SETTING: A 1355-bed university hospital. PATIENTS: 101 patients with suspected DVT who had had routine venography. Participants were recruited from a cohort of patients with suspected DVT. All patients with a positive venogram and one quarter of patients with a negative venogram were selected by using a random sequence. INTERVENTION: MRDTI was performed within 48 hours of venography and was interpreted by two reviewers. MEASUREMENTS: Diagnosis of DVT overall; isolated calf, femoropopliteal, and ileofemoral DVT; and thrombus in the calf, femoropopliteal, and iliac segments. RESULTS: The reports from two readers had sensitivities of 96% and 94% and specificities of 90% and 92% for diagnosis of DVT. Sensitivities were 92% and 83% for isolated calf DVT, 97% and 97% for femoropopliteal DVT, and 100% and 100% for ileofemoral DVT. Specificities were 94% and 96% for isolated calf DVT and 100% and 100% for both femoropopliteal and ileofemoral DVT. Similarly, sensitivity and specificity within each of the venous segments ranged from 91% to 100%. Interobserver variability measured by using a weighted kappa statistic ranged from 0.89 to 0.98 for these measures. CONCLUSION: Magnetic resonance direct thrombus imaging is an accurate noninvasive test for diagnosis of DVT, and its accuracy is maintained below the knee. Comparison of individual venous segments showed that results of MRDTI agreed strongly with findings on venography. Scanning was well tolerated, and interpretation was highly reproducible.

Re-evaluation of iliac compression syndrome using magnetic resonance imaging in patients with acute deep venous thromboses.

BACKGROUND: The majority of proximal deep venous thromboses (DVTs) are thought to have propagated as a contiguous column from the calf veins. However, several authors have proposed that ileofemoral DVT commonly originates in the left common iliac vein (LCIV) at a site of compression by the overlying right common iliac artery (RCIA/LCIV compression). This mechanism could explain both the left-sided predominance of ileofemoral DVT and the finding that ileofemoral DVT frequently occurs either in the absence of calf vein thrombosis (isolated ileofemoral DVT) or is not contiguous with calf vein thrombosis (noncontiguous ileofemoral DVT). This mechanism remains unconfirmed. OBJECTIVES: The purpose of this study was to detect RCIA/LCIV compression using multimodal magnetic resonance imaging in thrombosed and patent iliac veins, to determine whether RCIA/LCIV compression occurs more frequently in cases of left ileofemoral DVT than other types of DVT, and to determine if RCIA/LCIV compression is specifically associated with left isolated and noncontiguous ileofemoral DVT. PATIENTS AND METHODS: This prospective study conducted at the 1355-bed University Hospital included 18 patients with ileofemoral DVT, 23 with femoropopliteal DVT, 15 with isolated calf DVT recruited consecutively, and 28 control patients in whom DVT had been excluded. Interventions included magnetic resonance direct thrombus imaging (MRDTI), venous enhanced peak arterial magnetic resonance venography (VESPA) and magnetic resonance arteriography (MRA) within 48 hours of routine conventional venography (CV). RCIA/LCIV compression of patent LCIVs was assessed using VESPA and MRA; RCIA/LCIV compression of thrombosed LCIVs was assessed using MRDTI and MRA. The extent of calf and popliteal thrombosis was detected using CV; the extent of femoral and iliac thrombosis was detected using VESPA and MRDTI. RESULTS: RCIA/LCIV compression was more commonly detected in cases of left ileofemoral DVT (9/16 cases) than in cases of left femoropopliteal DVT (1/11 cases; P = .018), right femoropopliteal DVT (2/12 cases; P = .054), left isolated calf DVT (1/9 cases; P = .037), right isolated calf DVT (0/6 cases; P = .046) and control patients (4/28 cases; P = .006). RCIA/LCIV compression was more commonly detected in cases of left isolated ileofemoral DVT (6/6 cases; P = .005), and cases of left noncontiguous ileofemoral DVT (2/2 cases; P = .067) than in cases in which thrombosis was contiguous from the calf to the iliac veins (1/8 cases). CONCLUSION: RCIA/LCIV compression was strongly associated with left ileofemoral DVT and was specifically associated with cases that involve independent ileofemoral thrombosis.

Iliac compression syndrome and recanalization of femoropopliteal and iliac venous thrombosis: a prospective study with magnetic resonance venography.

OBJECTIVES: Poor iliac vein recanalization has been associated with compression of the left common iliac vein by the right common iliac artery (RCIA/LCIV compression); however, this finding has been difficult to confirm. In a baseline study, RCIA/LCIV compression was detected with magnetic resonance imaging in patients with deep venous thrombosis. We compared recanalization of left femoropopliteal and iliac thrombosis with and without RCIA/LCIV compression. METHODS: This was a prospective blinded study carried out in a 1355-bed university hospital. Thirty-one patients were recruited from consecutive cohorts of patients with iliofemoral and femoropopliteal DVT who underwent direct thrombus magnetic resonance imaging, venous enhanced peak arterial magnetic resonance venography, and magnetic resonance arteriography as part of the baseline study relating RCIA/LCIV compression to extent of thrombosis. Magnetic resonance venography was performed 6 weeks, 6 months, and 1 year after diagnosis of deep venous thrombosis. Femoropopliteal and iliac venous segments that were occluded at diagnosis were classified as occluded, partially occluded, or patent on follow-up scans. RESULTS: At 6-week follow-up, recanalization of all segments was incomplete. At both 6-month and 1-year follow-up, recanalization of left iliac segments associated with RCIA/LCIV compression was poorer compared with recanalization of left iliac segments not associated with compression (6 of 6 occluded vs 1 of 6 occluded and 1 of 6 partially occluded at 6 months, P =.015; 6 of 6 occluded vs 5 of 5 patent at 1 year, P = .002). This was due to complete failure of recanalization of left common iliac veins associated with RCIA/LCIV compression in 6 of 6 cases. All other iliac and femoropopliteal segments including left external iliac veins associated with RCIA/LCIV compression had high rates of recanalization at both 6 months and 1 year. CONCLUSION: RCIA/LCIV compression is associated with persistent occlusion of the left common iliac vein. The recanalization rate for all other femoropopliteal and iliac segments was high.

Deep venous thrombosis: diagnosis by using venous enhanced subtracted peak arterial MR venography versus conventional venography.

PURPOSE: To assess diagnostic accuracy and interobserver variability at venous enhanced subtracted peak arterial (VESPA) magnetic resonance (MR) venography compared with those at conventional venography for the diagnosis of femoral and iliac deep venous thrombosis (DVT). MATERIALS AND METHODS: A single anteroposterior maximum intensity projection (MIP) venogram of the femoral and iliac veins was constructed by using VESPA MR venography in 55 symptomatic patients suspected of having lower limb DVT. All patients also underwent conventional venography, results of which were used as the standard of reference. VESPA MR venograms were interpreted by two independent reviewers (reviewers A and B) who were unaware of other results. Sensitivity and specificity of VESPA MR venography for the diagnosis of thrombus in the femoral and iliac veins were calculated. Interobserver variability was calculated for these observations by using weighted kappa with equally spaced weights for positive, nondiagnostic, and negative studies. Nondiagnostic studies were reinterpreted separately by reviewer A on the basis of source data. RESULTS: Sensitivity of VESPA MR venography for the femoral veins (20 of 20) and iliac veins (seven of seven) was 100% for both reviewers. Specificity was 100% (39 of 39 for reviewer A, 40 of 40 for reviewer B) for the iliac veins and 97% (31 of 32) for the femoral veins for both reviewers. Segments in which the VESPA MR venograms were nondiagnostic were excluded from this analysis. Interobserver variability as calculated by using weighted kappa for positive, negative, and nondiagnostic studies was 0.85 for femoral veins and 0.97 for iliac veins. Interpretation of the source data led to correct diagnosis in six of six cases in which the VESPA MR venograms were nondiagnostic. CONCLUSION: VESPA MR venography yielded MIP venograms that were highly accurate for the diagnosis of DVT in femoral and iliac veins. Interpretation of the studies was also highly reproducible.