Transcatheter Aortic Valve Replacement Valve Research Articles

Comparison of Post-Procedural and 30-day Post-Implantation Transcatheter Aortic Valve Replacement Gradients with and without pre-implantation Balloon Valvuloplasty: A Real-World Analysis of Early Results using a Novel Balloon Expandable Transcatheter Aortic Valve

Objectives: This study describes a real-world experience of implanting a novel balloon expandable transcatheter aortic valve replacement (TAVR) compared to devices commonly used in clinical practice. As a secondary objective, the effect of balloon angioplasty (BAV) before TAVR on the transvalvular gradient 1 and 30 days after implantation was evaluated. Background: For most commercial TAVR valves, the 30-day average mean aortic valve gradients have been reported. Our experience with the Lotus Valve System had indicated higher immediate post-implant gradients than those in the literature. We sought to evaluate both these valves, comparing them to other valves. Methods: We analyzed discharge and 30-day echocardiograms of Lotus valves from 7/5/2019 to 8/27/2020. In response to higher-than-expected post-implant gradients, patients from 11/4/19 to 8/27/20 underwent BAV before the valve implantation, whereas patients from 7/5/19 to 10/18/19 did not (no-BAV). We compared these samples to each other and to a random sampling of TAVR valves implanted by the same interventionalist. Results: At discharge, 27 patients received Lotus valves. The average mean aortic valve gradient was 16.7 mmHg (SD = 5.5 mmHg) for the no-BAV and 14.7 mmHg (SD = 3.7 mmHg) for the BAV (P = 0.177) cohorts. No-BAV Lotus valve mean gradients were significantly higher (P < 0.001) than those of the Sapien valve (M = 12 mmHg, SD = 4.3) and CoreValve (M = 9.18 mmHg, SD = 3.96). At the 30-day assessment, the mean gradients in the no-BAV and BAV groups were similar to those in the literature (M = 11 mmHg SD 3.5; M = 12 mmHg, SD 4.1 (P = 0.287)) and those of other valves. Conclusions: The Lotus valve demonstrated higher post-implantation gradients than other valves. This effect was not attenuated by BAV. These elevated gradients were not significant at the 30-day follow-up.

Transcatheter Aortic Valve Replacement Versus Sutureless and Rapid Deployment Surgical Aortic Valve Replacement: A Systematic Review and Meta-Analysis

Transcatheter aortic valve replacement (TAVR) and sutureless and rapid deployment (SURD) valves are alternatives to traditional surgical aortic valve replacement (AVR). However, there is a paucity of data comparing these newer techniques. We performed a systematic review and meta-analysis comparing clinical outcomes between TAVR and SURD valves.

Cerebral protection in TAVR – can we do without? Impact on stroke rate, length of hospital stay and 12-month mortality

Abstract Stroke associated with transcatheter aortic valve replacement (TAVR) is a potentially devastating complication. Until recently, the Sentinel™ Cerebral Protection System (CPS; Boston Scientific) has been the only commercially available device for mechanical prevention of TAVR-related stroke. However, its effectiveness is still undetermined. Methods Between January 2019 and August 2020 consecutive patients were randomly assigned to TAVR with or without Sentinel™ in a 1:1 fashion. We defined as primary endpoint clinically detectable cerebrovascular events within 72 hours after TAVR, and as secondary endpoints LOS and 12-month mortality. Logistic and linear regression analyses were used to assess associations of Sentinel™ use with endpoints. Results Of 411 patients (80±7 y/o, 47.4% female, EuroSCORE II 6.3±5.9%), Sentinel™ was used in 213 (51.8%), with both filters correctly deployed in 189 (46.0%). 20 (4.9%) cerebrovascular events were recorded, 10 (2.4%) of which were disabling strokes. Sentinel™ reduced cerebrovascular events in univariate analysis by 71% (OR 0.29, 95% CI 0.11–0.82; p=0.02) and after multivariate adjustment by 75% (adj. OR 0.25; 95% CI 0.08–0.80; p=0.02). Sentinel™ use was also significantly associated with shorter LOS (8.4±9.6 versus 6.7±6.1 days; p=0.03) and lower 12-month all-cause mortality (15.7% versus 7.5%, p=0.01). Conclusions In the present prospective all-comers TAVR cohort, Sentinel™ significantly 1) reduced cerebrovascular events, 2) shortened LOS, and 3) improved 12-month survival. These data promote the use of a CPS when implanting TAVR valves. Funding Acknowledgement Type of funding sources: None.

Current and future transcatheter aortic valve replacement valves.

This review analyzes currently available commercial transcatheter aortic valve replacement (TAVR) valves as well as valves in investigational status and those in preclinical testing. The design features and clinical outcomes of the Edwards SAPIEN S3 and Medtronic Evolut PRO+ are described and compared with highlight clinical circumstances where one may be favoured over the other. Multiple randomized and nonrandomized trials have compared commercial and investigational TAVR valves. The results of these are summarized and discussed within this review with a focus on how the SAPIEN S3 and Evolut PRO+ both compare to each other as well as various valves in different investigational stages. TAVR is an innovative and ground-breaking technology that will forever have revolutionized the management of aortic stenosis. Though the technology and valves themselves have come a long way, further developments are necessary if we are to continue to expand its indications and achieve a safer perioperative experience with more durable valves.

Electrophysiologic Implications of Transcatheter Aortic Valve Replacement: Incidence, Outcomes, and Current Management Strategies.

Transcatheter aortic valve replacement (TAVR) has changed the paradigm for management of severe aortic stenosis. Despite substantial procedural advancements, conduction system abnormalities remain a common complication following TAVR. In this review, we describe (1) incidence and risk factors for the development of conduction disturbances following TAVR, along with their prognostic significance, (2) the incidence and prognostic significance of new-onset arrhythmias following TAVR, (3) approach to management of perioperative and post-procedural conduction disturbances and arrhythmias, and (4) novel areas of research. Conduction disturbances including left bundle branch block (LBBB) and high-grade atrioventricular block (HAVB) remain common issues post-TAVR despite advancements in valve technology and improvements in procedural technique. Despite data showing most conduction abnormalities resolve over time, rates of post-procedural permanent pacemaker implantation remain high. Similarly, rates of new-onset or newly detected arrhythmia, particularly atrial fibrillation, have been widely reported post-implantation of all types of TAVR valves. Recent consensus statements and decision pathway documents have been helpful in standardizing an approach to post-TAVR conduction disturbances. New areas of research show promise both for predicting which patients will develop conduction disturbances post-TAVR and for management of HAVB with novel pacing techniques. On the other hand, management of new-onset or newly detected atrial fibrillation after TAVR remains a significant challenge without standardized treatment strategy.

Surgical explantation of transcatheter aortic bioprosthesis: A systematic review and meta-analysis

BackgroundDespite the rapid adoption of transcatheter aortic valve replacement (TAVR), aortic valve reintervention, particularly surgical TAVR valve explantation (TAVR explant), has not been well described. MethodsMEDLINE, Embase, and Web of Science were searched through July 2021 to identify observational studies and case series reporting clinical outcomes of TAVR explant. Data on the frequency of TAVR explant, patient demographic characteristics, clinical indications, operative data, and perioperative outcomes were extracted. Study-specific estimates were combined using one-group meta-analysis in a random-effects model. ResultsA total of 10 studies were identified that included 1690 patients undergoing a TAVR explant. The frequency of TAVR explant among TAVR recipients was 0.4% (95% confidence interval [CI], 0.2%-0.6%). The mean patient age was 73.7 years (95% CI, 72.9-74.6 years). The mean Society of Thoracic Surgeons predicted risk of mortality was 5.9% (95% CI, 2.9%-8.8%) at the index TAVR and 8.1% (95% CI, 5.4%-10.8%) at TAVR explant. The mean time from implant to explant was 345.0 days (95% CI, 196.7-493.3 days). Among patients with documented device type, 59.8% (95% CI, 43.5%-76.0%) had a balloon-expandable valve and 40.2% (95% CI, 24.0%-56.5%) had a self-expandable valve. Concomitant procedures during TAVR explant were performed in 52.9% of patients (95% CI, 33.8%-72.0%), and the most common concomitant procedure was aortic repair (28.5%; 95% CI, 14.0%-42.9%). The 30-day mortality after TAVR explant was 16.7% (95% CI, 12.2%-21.2%). ConclusionsTAVR explant in patients with a failing TAVR appears to be rare; however, the clinical impact of TAVR explant is substantial. Implanters must be mindful of the need for a lifetime management strategy in younger and lower-risk patients when choosing the valve type for the initial procedure.

Aortic valve reintervention after transcatheter aortic valve replacement

BackgroundDespite the rapid adoption of transcatheter aortic valve replacement (TAVR), there are scant data regarding aortic valve reintervention after initial TAVR. MethodsBetween 2011 and 2019, 1487 patients underwent a TAVR at the University of Michigan. Among these, 24 (1.6%) patients required an aortic valve reintervention. Additionally, 4 patients who received a TAVR at another institution underwent a valve reintervention at our institution. We retrospectively reviewed these 28 patients. ResultsThe median age was 72 years, 36% were female and 86% of implanted TAVR devices were self-expandable. The leading indications for reintervention were structural valve degeneration (39%) and paravalvular leak (36%). The cumulative incidence of aortic valve reintervention was 4.6% at 8 years. Most (71%) were deemed unsuitable for repeat TAVR because of the need for concurrent cardiac procedures (50%), unfavorable anatomy (45%), or endocarditis (10%). TAVR valve explant was associated with frequent concurrent procedures, consisting of aortic repair (35%), mitral repair/replacement (35%), tricuspid repair (25%), and coronary artery bypass graft (20%). Seventy-one percent of aortic procedures were unplanned but proved necessary because of severe adhesion of the devices to the contacting tissue. There were 3 (15%) in-hospital mortalities in the TAVR valve explant group, whereas there was no mortality in the repeat TAVR group. ConclusionsRepeat TAVR procedure was frequently not feasible because of unfavorable anatomy and/or the need for concurrent cardiac procedures. Careful assessment of TAVR procedure repeatability should be weighed at the initial TAVR workup especially in younger patients who are expected to require a valve reintervention.

Long-Term Outcome with New Generation Prostheses in Patients Undergoing Transcatheter Aortic Valve Replacement.

The aim of this study was to compare patients with transcatheter aortic valve replacement (TAVR) receiving new generation prostheses SAPIEN 3 (S3, Edwards Lifesc.) and Evolut R (ER, Medtronic Inc.) in terms of periprocedural and long-term outcome. Our retrospective, single-center analysis included 359 consecutive patients with severe aortic stenosis who underwent TAVR with S3 or ER from 2014–2016 (mean age 82 ± 7 years, 47% male, mean EuroSCORE II 8.0 ± 8%, mean follow-up 3.8 years). Device Success was equal (S3 93.0% vs. ER 92.4%, p = 0.812). We report a 30-day mortality of 2.8% in the S3 group, and 2.1% in the ER group (p = 0.674). There was no difference in stroke, conversion to open surgery, vascular and bleeding complications or myocardial infarction. While prosthesis mean gradients were higher with S3 (12.0 mmHg vs. 8.2 mmHg, p < 0.001), there was a trend to less paravalvular regurgitation (PVR moderate or severe: 1% vs. 3.6%, p = 0.088). All-cause mortality up to 5 years did not show a difference (mean survival S3 3.5 ± 0.24 years, ER 3.3 ± 0.29 years, p = 0.895). Independent predictors of long-term mortality were impaired LVEF, chronic kidney injury, peripheral artery disease, malignant tumor and periprocedural stroke. New generation TAVR valves offer an excellent implant and outcome success rate. Long-term survival was independent of prostheses choice and mainly attributed to comorbidities and complications.

Pacemaker dependency after transcatheter aortic valve replacement compared to surgical aortic valve replacement.

Transcatheter aortic valve replacement (TAVR) is a standard treatment indicated for severe aortic stenosis in high-risk patients. The objective of this study was to evaluate the incidence of pacemaker dependency after permanent pacemaker implantation (PPI) following TAVR or surgical aortic valve replacement (SAVR) and the risk of mortality at a tertiary center in Korea.In this retrospective study conducted at a single tertiary center, clinical outcomes related to pacemaker dependency were evaluated for patients implanted with pacemakers after TAVR from January 2012 to November 2018 and post-SAVR from January 2005 to May 2015. Investigators reviewed patients’ electrocardiograms and baseline rhythms as well as conduction abnormalities. Pacemaker dependency was defined as a ventricular pacing rate > 90% with an intrinsic rate of <40 bpm during interrogation.Of 511 patients who underwent TAVR for severe AS, 37(7.3%) underwent PPI after a median duration of 6 (3–7) days, whereas pacemakers were implanted after a median interval of 13 (8–28) days post-SAVR in 10 of 663 patients (P < .001). Pacemaker dependency was observed in 36 (97.3%) patients during 7 days immediately post-TAVR and in 25 (64.9%) patients between 8 and 180 days post-TAVR. Pacemaker dependency occurred after 180 days in 17 (50%) patients with TAVR and in 4 (44.4%) patients with SAVR. Twelve (41.4%) patients were pacemaker-dependent after 365 days post-TAVR.Pacemaker dependency did not differ at 6 months after TAVR vs SAVR. In patients undergoing post-TAVR PPI, 58.6% were not pacemaker-dependent at 1 year after the TAVR procedure.

Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Rheumatic Aortic Stenosis

BackgroundPatients with rheumatic aortic stenosis (AS) were excluded from transcatheter aortic valve replacement (TAVR) trials. ObjectivesThe authors sought to examine outcomes with TAVR versus surgical aortic valve replacement (SAVR) in patients with rheumatic AS, and versus TAVR in nonrheumatic AS. MethodsThe authors identified Medicare beneficiaries who underwent TAVR or SAVR from October 2015 to December 2017, and then identified patients with rheumatic AS using prior validated International Classification of Diseases, Version 10 codes. Overlap propensity score weighting analysis was used to adjust for measured confounders. The primary study outcome was all-cause mortality. Multiple secondary outcomes were also examined. ResultsThe final study cohort included 1,159 patients with rheumatic AS who underwent aortic valve replacement (SAVR, n = 554; TAVR, n = 605), and 88,554 patients with nonrheumatic AS who underwent TAVR. Patients in the SAVR group were younger and with lower prevalence of most comorbidities and frailty scores. After median follow-up of 19 months (interquartile range: 13 to 26 months), there was no difference in all-cause mortality with TAVR versus SAVR (11.2 vs. 7.0 per 100 person-year; adjusted hazard ratio: 1.53; 95% confidence interval: 0.84 to 2.79; p = 0.2). Compared with TAVR in nonrheumatic AS, TAVR for rheumatic AS was associated with similar mortality (15.2 vs. 17.7 deaths per 100 person-years (adjusted hazard ratio: 0.87; 95% confidence interval: 0.68 to 1.09; p = 0.2) after median follow-up of 17 months (interquartile range: 11 to 24 months). None of the rheumatic TAVR patients, <11 SAVR patients, and 242 nonrheumatic TAVR patients underwent repeat aortic valve replacement (124 redo-TAVR and 118 SAVR) at follow-up. ConclusionsCompared with SAVR, TAVR could represent a viable and possibly durable option for patients with rheumatic AS.

Meta-Analysis of Stroke and Mortality Rates in Patients Undergoing Valve-in-Valve Transcatheter Aortic Valve Replacement.

BackgroundDuring the past decade, the use of transcatheter aortic valve replacement (TAVR) was extended beyond treatment‐naïve patients and implemented for treatment of degenerated surgical bioprosthetic valves. Selection criteria for either valve‐in‐valve (viv) TAVR or redo surgical aortic valve replacement are not well established, and decision making on the operative approach still remains challenging for the interdisciplinary heart team.Methods and ResultsThis review was intended to analyze all studies on viv‐TAVR focusing on short‐ and mid‐term stroke and mortality rates compared with redo surgical aortic valve replacement or native TAVR procedures. A structured literature search and review process led to 1667 potentially relevant studies on July 1, 2020. Finally, 23 studies fulfilled the inclusion criteria for qualitative analysis. All references were case series either with or without propensity score matching and registry analyses. Quantitative synthesis of data from 8509 patients revealed that viv‐TAVR is associated with mean 30‐day stroke and mortality rates of 2.2% and 4.2%, respectively. Pooled data analysis showed no significant differences in 30‐day stroke rate, 30‐day mortality, and 1‐year mortality between viv‐TAVR and comparator treatment (native TAVR [n=11 804 patients] or redo surgical aortic valve replacement [n=498 patients]).ConclusionsThis review is the first one comparing the risk for stroke and mortality rates in viv‐TAVR procedures with native TAVR approach and contributes substantial data for the clinical routine. Moreover, this systematic review is the most comprehensive analysis on ischemic cerebrovascular events and early mortality in patients undergoing viv‐TAVR. In this era with increasing numbers of bioprosthetic valves used in younger patients, viv‐TAVR is a suitable option for the treatment of degenerated bioprostheses.

Practical Application of Patient-Reported Health Status Measures for Transcatheter Valve Therapies: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry.

Health status assessment is essential for documenting the benefit of transcatheter aortic valve replacement (TAVR) or transcatheter mitral valve repair on patients' symptoms, function, and quality of life. Health status can also be a powerful marker for subsequent clinical outcomes, but its prognostic importance around the time of both TAVR and transcatheter mitral valve repair has not been fully defined. Among 73 699 patients who underwent transfemoral TAVR or transcatheter mitral valve repair between 2011 and 2018 (mean age, 81.9±7.0 years, 53% men, 92% TAVR), we constructed sequential models examining the association of health status (as assessed with the Kansas City Cardiomyopathy Questionnaire-Overall Summary Score; KCCQ-OS) at baseline, 30 days, change from baseline to 30 days, and combinations of these assessments with death and heart failure (HF) hospitalization from 30 days to 1 year. Although higher baseline KCCQ-OS and 30-day KCCQ-OS scores were each associated with lower risk of death and HF hospitalization (in individual models and in a model including both measures), the 30-day KCCQ-OS was most predictive (death: hazard ratio, 0.89 per 5-point increase [95% CI, 0.89-0.90]; HF hospitalization: hazard ratio, 0.91 [95% CI, 0.90-0.91]). The 30-day KCCQ-OS also was most predictive when included in a separate model with change in KCCQ from baseline to 30 days. Similar findings were noted for the outcomes of death and of HF hospitalization, unadjusted and adjusted for patient factors. All interaction terms between procedure type and KCCQ were not significant, suggesting that health status provided similar prognostic information in both procedures. The patient's assessment of their health status immediately before and 30 days after TAVR and transcatheter mitral valve repair is associated with subsequent risk of death and HF hospitalization, with the 30-day assessment being most strongly associated with outcomes. Our findings support the routine use of KCCQ data as a prognostic tool.

Women and transcatheter aortic valve implantation: Also a mismatch could be tomorrow's best match

Key Points What the article teaches. Patient prosthesis mismatch (PPM) occurs in a third of women after transcatheter aortic valve replacement (TAVR), in association with small valve size and higher BMI, apparently without short‐term clinical consequences. How it will impact practice. Implementation strategies to minimize the incidence of PPM in patients at risk, that are mainly women, is important. What new research/study would help answer the question posed. Differential clinical impact of PPM on TAVR and surgical aortic valve replacement should be further investigated, as well as the hypothesis that TAVR might represent the best therapeutic option for women with severe aortic stenosis.

Pacemaker following transcatheter aortic valve replacement and tricuspid regurgitation:A single-center experience.

As transcatheter aortic valve replacement (TAVR) procedures increase, more data is available on the development of conduction abnormalities requiring permanent pacemaker (PPM) implantation post-TAVR. Mechanistically, new pacemaker implantation and incidence of associated tricuspid regurgitation (TR) post-TAVR is not well understood. Studies have evaluated the predictability of patient anatomy towardsrisk for needing permanent pacemaker (PPM) post-TAVR; however, little has been reported on new PPM and TR in patients post-TAVR. This retrospective study identified patients at our health system who underwent PPM following TAVR from January 2014 to June 2018. Data from both TAVR and PPM procedures as well as patient demographics were collected. Echocardiographic data before TAVR, between TAVR and PPM placement, and the most recent echocardiogram at the time of chart review were analyzed. Of 796 patients who underwent TAVR between January 2014 and June 2018, 89 patients (11%) subsequently required PPM. Out of the 89 patients who required PPM implantation, 82 patients had pre-TAVR and 2-year post-TAVR echocardiographic imaging data. At baseline, 22% (18/82) of patients had at least moderate TR. At 2-year post-TAVR echocardiographic imaging follow-up; 27% (22/82) of patients had at least moderate TR. Subgroup analysis was performed according to the TAVR valve size implanted. In patients who received a TAVR device < 29 mm in diameter in size, 25% (11/44) had worsening TR. In patients who received a TAVR device ≥ 29 mm in diameter, 37% (14/38) had worsening TR. We have demonstrated a patient population that may be predisposed to developing worsening TR and right heart function after TAVR and Pacemaker implantation.

A combination of hydrogen bonding and chemical covalent crosslinking to fabricate a novel swim-bladder-derived dry heart valve material yields advantageous mechanical and biological properties

The current biological valve products used in transcatheter aortic valve replacement (TAVR) are mainly made of glutaraldehyde (GLUT)-crosslinked porcine and bovine pericardia, which need to be transported and stored in GLUT solution. This leads to prolonged preparation time and the presence of GLUT residue. Therefore, there has been interest in developing TAVR valves using a pre-crimped valve (also known as a dry valve). Herein, a natural, inexpensive, and widely available swim bladder was selected as the source of a biological valve functioning as a dry valve and was obtained via acellular processes and crosslinking fixation. With the help of multiple hydrogen bonds between polyphenols (represented by procyanidin and curcumin) and tissue, as well as the chemical crosslinking of 1-(3-dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride (EDC) with tissue, we found that this novel combined crosslinking method was able to successfully crosslink with an acellular swim bladder. The stabilities, mechanical properties, resistance to pre-folding/pre-compressing, flattening capability in water, hemocompatibility, cytocompatibility, and anti-calcification capability were systematically measured via a series of experiments. We demonstrated that this dry valve resulting from a combination of EDC/polyphenols exhibited superior properties compared with those of a control pericardial-based valve.

Temporal Trends and Outcomes of Percutaneous and Surgical Aortic Valve Replacement in Patients With Atrial Fibrillation.

Objectives: The aim of this study was to evaluate the temporal trends of transcatheter aortic valve replacement (TAVR) in severe aortic stenosis (AS) patients with atrial fibrillation (AF) and to compare the in-hospital outcomes between TAVR and surgical aortic valve replacement (SAVR) in patients with AF.Background: Data comparing TAVR to SAVR in severe AS patients with AF are lacking.Methods: National inpatient sample database in the United States from 2012 to 2016 were queried to identify hospitalizations for severe aortic stenosis patients with AF who underwent isolated aortic valve replacement. A propensity score-matched analysis was used to compare in-hospital outcomes for TAVR vs. SAVR for AS patients with AF.Results: The analysis included 278,455 hospitalizations, of which 124,910 (44.9%) were comorbid with AF. Before matching, TAVR had higher in-hospital mortality than SAVR (3.1 vs. 2.2%, p < 0.001); however, there was a declining trend during the study period (Ptrend < 0.001). After matching, TAVR and SAVR had similar in-hospital mortality (2.9 vs. 2.9%, p < 0.001) and stroke. TAVR was associated with lower rates of acute kidney injury, new dialysis, cardiac complications, acquired pneumonia, sepsis, mechanical ventilation, tracheostomy, non-routine discharge, and shorter length of stay; however, TAVR was associated with more pacemaker implantation and higher cost. Of the patients receiving TAVR, the presence of AF was associated with an increased rate of complications and increased medical resource usage compared to those without AF.Conclusions: In-hospital mortality and stroke for TAVR and SAVR in AF, AS are similar; however, the in-hospital mortality in TAVR AF is declining and associated with more favorable in-hospital outcomes.

Changes in outcomes over time in intermediate-risk patients treated for severe aortic stenosis.

The advent of transcatheter aortic valve replacement (TAVR) has changed the practice of treating patients with severe aortic stenosis (AS). Heart-Teams have improved their decision-making process to refer patients to the best and safest treatment. The evidence allowed centers to increase funding and TAVR volume and extend indications to different risk categories of patients. This study evaluates the outcomes of intermediate-risk patients treated for severe AS in an academic center. Between 2012 and 2019, 812 patients with AS underwent TAVR or surgical aortic valve replacement (SAVR). A propensity score-matching analytic strategy was used to balance groups and adjust for time periods. Outcomes were recorded according to the Society of Thoracic Surgeons Guidelines; the primary outcome being 30-day mortality and the secondary outcomes being perioperative course and complications. No difference in mortality was seen but complications differed: more postoperative transient ischemic attacks, permanent pacemaker implantations, and perivalvular leaks in the transcatheter group, while more acute kidney injuries, atrial fibrillation, delirium, postoperative infections and bleeding, tamponade and need for reoperation in the surgical group as well as a longer hospital length-of-stay. However, over the years, morbidities/mortality decreased for all patients treated for AS. Data showed an improvement in morbidities/mortality for intermediate-risk patients treated with SAVR or TAVR. Increased funding allowed for a higher TAVR volume by increasing access to this technology. Also, the difference in complications could impact healthcare costs. By incorporating important metrics such as length-of-stay, readmission rates, and complications into decision-making, the Heart-Team can improve clinical outcomes, healthcare economics, and resource utilization.

Transcatheter vs surgical aortic valve replacement in low to intermediate surgical risk aortic stenosis patients: A systematic review and meta-analysis of randomized controlled trials.

BackgroundTranscatheter aortic valve replacement (TAVR) is regarded as the most superior alternative treatment approach for patients with aortic stenosis (AS) who are associated with high surgical risk, whereas the effectiveness of TAVR vs surgical aortic valve replacement (SAVR) in low to intermediate surgical risk patients remained inconclusive. This study aimed to determine the best treatment strategies for AS with low to intermediate surgical risk based on published randomized controlled trials (RCTs).Hypothesis and MethodsRCTs that compared TAVR vs SAVR in AS patients with low to intermediate surgical risk were identified by PubMed, EmBase, and the Cochrane library from inception till April 2019. The pooled relative risks (RRs) with 95% confidence intervals (CIs) were calculated for the data collected using random‐effects models.ResultsSeven RCTs with a total of 6929 AS patients were enrolled. We noted that TAVR significantly increased the risk of transient ischemic attack (TIA) (RR: 1.43; 95%CI: 1.04‐1.96; P = .029), and permanent pacemaker implantation (RR: 3.00; 95%CI: 1.70‐5.30; P < .001). However, TAVR was associated with lower risk of post‐procedural bleeding (RR: 0.57; 95%CI: 0.33‐0.98; P = .042), new‐onset or worsening of atrial fibrillation (RR: 0.32; 95%CI: 0.23‐0.45; P < .001), acute kidney injury (RR: 0.40; 95%CI: 0.25‐0.63; P < .001), and cardiogenic shock (RR: 0.34; 95%CI: 0.19‐0.59; P < .001). The risk of aortic‐valve reintervention at 1‐ (RR: 2.63; 95%CI: 1.34‐5.15; P = .005), and 2 years (RR: 3.19; 95%CI: 1.63‐6.24; P = .001) in low to intermediate surgical risk patients who received TAVR was significantly increased than those who received SAVR.ConclusionsThese findings indicated that low to intermediate surgical risk patients who received TAVR had low risk of complications, whereas the risk of TIA, permanent pacemaker implantation, and aortic‐valve reintervention was increased.

Adverse clinical outcomes in patients undergoing both PCI and TAVR: Analysis from a pooled multi-center registry.

There is a paucity of data regarding the optimum timing of PCI in relation to TAVR. We compared the major adverse cardiovascular and cerebrovascular events (MACCE) rates among patients who underwent percutaneous coronary intervention (PCI) before transcatheter aortic valve replacement (TAVR) with those who received PCI with/after TAVR. In this multicenter study, we pooled all consecutive patients who underwent TAVR at three high volume centers. Among 3,982 patients who underwent TAVR, 327 (8%) patients underwent PCI within 1 year before TAVR, 38 (1%) had PCI the same day as TAVR and 15 (0.5%) had PCI within 2 months after TAVR. Overall, among patients who received both PCI and TAVR (n = 380), history of previous CABG (HR:0.501; p = .001), higher BMI at TAVR (HR:0.970; p = .038), and statin therapy after TAVR (HR:0.660, p = .037) were independently associated with lower MACCE while warfarin therapy after TAVR was associated with a higher risk of MACCE (HR:1.779, p = .017). Patients who received PCI within 1 year before TAVR had similar baseline demographics, STS scores, clinical risk factors when compared to patients receiving PCI with/after TAVR. Both groups were similar in PCI (Syntax Score, ACC/AHA lesion class) and TAVR (valve types, access) related variables. There were no significant differences in terms of MACCE (log rank p = .550), all-cause mortality (log rank p = .433), strokes (log rank p = .153), and repeat PCI (log rank p = .054) in patients who underwent PCI with/after TAVR when compared to patients who received PCI before TAVR. Among patients who underwent both PCI and TAVR, history of CABG, higher BMI, and statin therapy had lower, while those discharged on warfarin, had higher adverse event rates. Adverse events rates were similar regardless of timing of PCI.

Clinical Impact of Preexisting Right Bundle Branch Block after Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis.

Introduction Transcatheter aortic valve replacement (TAVR) is now the treatment of choice for patients with severe aortic stenosis regardless of their surgical risk. Right bundle branch block (RBBB) can be a predictor for development of significant atrioventricular (AV) block after TAVR, requiring permanent pacemaker implantation (PPI). However, data related to the risk of PPI requirement with preexisting RBBB is scarce. Hence, this systematic review and meta-analysis aims to assess clinical outcomes of patients undergoing TAVR with RBBB on preexisting electrocardiogram. Methods We performed a systematic literature review to identify randomized and nonrandomized clinical studies that reported any clinical impact of patients undergoing TAVR with preexisting RBBB. A total of eight databases including PubMed (Medline), Embase, Cochrane Library, ACP Journal Club, Scopus, DARE, and Ovid containing articles from January 2000 to May 2020 were analyzed. Results We identified and screened 224 potential eligible publications through the databases and found 14 relevant clinical trials for a total of 15,319 participants. There was an increased 30-day pacemaker implantation rate of 38.1% in the RBBB group compared to 11.4% in the no RBBB group with a risk ratio of 3.56 (RR 3.56 (95% CI 3.21–3.93, p < 0.01)). There was an increased 30-day all-cause mortality in the RBBB group of 9.5% compared with 6.3% in the no RBBB group with an odds ratio of 1.60 (OR 1.60 (95% CI 1.14–2.25, p < 0.01)). Conclusion This study indicates that patients with preexisting RBBB have higher incidence of PPI and all-cause mortality after TAVR compared with patients without RBBB. Further trials are needed to compare the clinical outcomes based on TAVR valve types and assess the benefit of PPI in patients with new-onset RBBB after TAVR.