Incidence, Predictor, and Clinical Outcomes of Multiple Resheathing With Self-Expanding Valves During Transcatheter Aortic Valve Replacement.

Background No study has evaluated the impact of the additional manipulation demanded by multiple resheathing (MR) in patients undergoing transcatheter aortic valve replacement with repositionable self-expanding valves. Methods and Results This study included a real-world, multicenter registry involving 16 centers from Canada, Germany, Latin America, and Spain. All consecutive patients who underwent transcatheter aortic valve replacement with the Evolut R, Evolut PRO, and Portico valves were included. Patients were divided according to the number of resheathing: no resheathing, single resheathing (SR), and MR. The primary end point was device success. Secondary outcomes included procedural complications, early safety events, and 1-year mortality. In 1026 patients, the proportion who required SR and MR was 23.9% and 9.3%, respectively. MR was predicted by the use of Portico and moderate/severe aortic regurgitation at baseline (both with P<0.01). Patients undergoing MR had less device success (no resheathing=89.9%, SR=89.8%, and MR=80%; P=0.01), driven by more need for a second prosthesis and device embolization. At 30 days, there were no differences in safety events. At 1 year, more deaths occurred with MR (no resheathing=10.5%, SR=8.0%, and MR=18.8%; P=0.014). After adjusting for baseline differences and center experience by annual volume, MR associated with less device success (odds ratio, 0.42; P=0.003) and increased 1-year mortality (hazard ratio, 2.06; P=0.01). When including only the Evolut R/PRO cases (N=837), MR continued to have less device success (P<0.001) and a trend toward increased mortality (P=0.05). Conclusions Repositioning a self-expanding valve is used in a third of patients, being multiple in ≈10%. MR, but not SR, was associated with more device failure and higher 1-year mortality, regardless of the type of valve implanted.

Valve-in-Valve Challenges: How to Avoid Coronary Obstruction.

Coronary obstruction is a rare but life-threatening complication in patients undergoing transcatheter aortic valve replacement (TAVR). Aortic valve-in-valve (VIV) procedures to treat failed surgical bioprosthesis is associated with ~6-fold higher risk for coronary obstruction in certain situations. The primary mechanism consists in the occlusion of the coronary ostium by the dislodged leaflet from the bioprosthesis after deployment of the transcatheter heart valve (THV), which most commonly occurs during the index procedure, but in up to 1/3 of cases a delayed presentation ensues. The clinical presentation consists of severe hypotension and ECG changes in most of the patients, with very high mortality rates. Therefore, pre-procedural multi-slice computed tomography is crucial for identifying high-risk features, such as low coronary heights, shallow sinuses of Valsalva, and short virtual THV to coronary ostial distance (VTC). Also, some models of surgical bioprosthesis present an increased risk for this dreadful complication. Preemptive protective strategies with coronary wiring, with or without placement of an undeployed stent, could mitigate the risks associated with this complication in high-risk patients, even though studies are lacking. This review aims to take a clinical perspective on the challenges in avoiding this complication during VIV procedures.

Direct Transcatheter Heart Valve Implantation Versus Implantation With Balloon Predilatation: Insights From the Brazilian Transcatheter Aortic Valve Replacement Registry.

BACKGROUND: Direct transcatheter aortic valve replacement (TAVR) is regarded as having potential advantages over TAVR with balloon aortic valve predilatation (BAVP) in reducing procedural complications, but there are few data to support this approach. METHODS AND RESULTS: Patients included in the Brazilian TAVR registry with CoreValve and Sapien-XT prosthesis were compared according to the implantation technique, with or without BAVP. Clinical and echocardiographic data were analyzed in overall population and after propensity score matching. A total of 761 consecutive patients (BAVP=372; direct-TAVR=389) were included. Direct-TAVR was possible in 99% of patients, whereas device success was similar between groups (BAVP=81.2% versus direct-TAVR=78.1%; P=0.3). No differences in clinical outcomes at 30 days and 1 year were observed, including all-cause mortality (7.6% versus 10%; P=0.25 and 18.1% versus 24.5%; P=0.07, respectively) and stroke (2.8% versus 3.8%; P=0.85 and 5.5% versus 6.8%; P=0.56, respectively). Nonetheless, TAVR with BAVP was associated with a higher rate of new onset persistent left bundle branch block with the CoreValve (47.7% versus 35.1%; P=0.01 at 1 year). Mean gradient and incidence of moderate/severe aortic regurgitation were similar in both groups at 1 year (11% versus 13.3%; P=0.57 and 9.8±5.5 versus 8.7±4.3; P=0.09, respectively). After propensity score matching analysis, all-cause mortality and stroke remained similar. By multivariable analysis, BAVP and the use of CoreValve were independent predictors of new onset persistent left bundle branch block. CONCLUSIONS: The 2 TAVR strategies, with or without BAVP, provided similar clinical and echocardiographic outcomes over a midterm follow-up although BAVP was associated with a higher rate of new onset persistent left bundle branch block, particularly in patients receiving a CoreValve.

Direct transcatheter heart valve implantation versus implantation with balloon predilatation: insights from the brazilian transcatheter aortic valve replacement registry

Background—Direct transcatheter aortic valve replacement (TAVR) is regarded as having potential advantages over TAVRwith balloon aortic valve predilatation (BAVP) in reducing procedural complications, but there are few data to supportthis approach. Methods and Results—Patients included in the Brazilian TAVR registry with CoreValve and Sapien-XT prosthesis were compared according to the implantation technique, with or without BAVP. Clinical and echocardiographic data were analyzed in overall population and after propensity score matching. A total of 761 consecutive patients (BAVP=372;direct-TAVR=389) were included. Direct-TAVR was possible in 99% of patients, whereas device success was similarbetween groups (BAVP=81.2% versus direct-TAVR=78.1%; P=0.3). No differences in clinical outcomes at 30 daysand 1 year were observed, including all-cause mortality (7.6% versus 10%; P=0.25 and 18.1% versus 24.5%; P=0.07,respectively) and stroke (2.8% versus 3.8%; P=0.85 and 5.5% versus 6.8%; P=0.56, respectively). Nonetheless, TAVRwith BAVP was associated with a higher rate of new onset persistent left bundle branch block with the CoreValve (47.7%versus 35.1%; P=0.01 at 1 year). Mean gradient and incidence of moderate/severe aortic regurgitation were similar inboth groups at 1 year (11% versus 13.3%; P=0.57 and 9.8±5.5 versus 8.7±4.3; P=0.09, respectively). After propensityscore matching analysis, all-cause mortality and stroke remained similar. By multivariable analysis, BAVP and the use ofCoreValve were independent predictors of new onset persistent left bundle branch block...

Surgical cutdown versus percutaneous access in transfemoral transcatheter aortic valve implantation: Insights from the Brazilian TAVI registry.

OBJECTIVE: To compare the 1-year outcomes of complete percutaneous approach versus surgical vascular approach for transfemoral transcatheter aortic valve implantation (TAVI), among "real-world" patients from the multi-center Brazilian TAVI registry. BACKGROUND: Vascular access still remains a major challenge for TAVI via transfemoral approach. Vascular access through complete percutaneous approaches or through open surgical vascular techniques seems to be acutely similar. However, the long-term outcomes of both techniques remain poorly described. METHODS: The study population comprised all patients treated via transfemoral route in the Brazilian TAVI registry, a "real-world", nation-based, multi-center study. Patients were divided according to the initial vascular access approach (percutaneous vs. surgical) and clinically followed-up for 1 year. The primary endpoint was the incidence of combined adverse events all-cause mortality, life-threatening bleeding, and/or major vascular complication at 1 year. RESULTS: A total of 402 patients from 18 centers comprised the study population (percutaneous approach in 182 patients; surgical cutdown approach 220 patients). The incidence of combined adverse events was not different in the percutaneous and the surgical groups at 30 days (17.6% vs. 16.3%; P = 0.8) and at 1 year (primary endpoint) (30.9% vs. 28.8%; P = 0.8). Also, the study groups overall were comparable regarding the incidence of each individual safety adverse events at 30 days and at 1 year. CONCLUSION: Total percutaneous techniques or surgical cutdown and closure may provide similar safety and effectiveness during the first year of follow-up in patients undergoing transfemoral TAVI.