Permanent Pacemaker Reduction Using Cusp-Overlapping Projection in TAVR: A Propensity Score Analysis

ObjectivesThe aim of this study was to determine if modifying the classical implantation technique for self-expanding (SE) transcatheter aortic valve replacement to a novel cusp-overlapping projection (COP) technique results in a higher implantation depth (ID) and subsequently reduces the rate of permanent pacemaker implantation (PPMI).BackgroundThe COP technique presents the potential benefit of an optimized ID to reduce the rate of PPMI. However, only a few studies have compared clinical outcomes with those achieved using the standard technique. This is the first study to systematically evaluate this approach for SE transcatheter heart valves (THVs) in different populationsMethodsBeginning in February 2015, 444 patients were consecutively included. Propensity score matching was used to control baseline characteristics because of the observational nature of the study. In total, 161 pairs of patients were analyzed. Three methods were used to measure ID (noncoronary cusp [NCC] to the THV, mean of the NCC and the left coronary cusp [LCC] to the THV, and the deepest edge from the LCC and the NCC to the THV).ResultsID was significantly higher in COP cases when measuring from the NCC (4.2 mm vs 5.3 mm; P < 0.001) and the mean from the NCC and the LCC (5.3 mm vs 5.9 mm; P = 0.04), but not from the deepest edge. The PPMI rate was lower in the COP group: 19 (11.8%) vs 35 (21.7%) (P = 0.03; relative risk: 0.54; 95% CI: 0.32-0.91).ConclusionsThe present study showed that the COP technique significantly reduces PPMI in SE THV implantation compared with the classical implantation technique, with similar rates of complications.     

Predictors of Permanent Pacemaker Implantation in Patients With Severe Aortic Stenosis Undergoing TAVR : A Meta-Analysis

Background

Atrioventricular (AV) conduction disturbances requiring permanent pacemaker (PPM) implantation may complicate transcatheter aortic valve replacement (TAVR). Available evidence on predictors of PPM is sparse and derived from small studies.

Objectives

The objective of this study was to provide summary effect estimates for clinically useful predictors of PPM implantation after TAVR.

Methods

We performed a systematic search for studies that reported the incidence of PPM implantation after TAVR and that provided raw data for the predictors of interest. Data on study, patient, and procedural characteristics were abstracted. Crude risk ratios (RRs) and 95% confidence intervals for each predictor were calculated by use of random effects models. Stratified analyses by type of implanted valve were performed.

Results

We obtained data from 41 studies that included 11,210 TAVR patients, of whom 17% required PPM implantation after intervention. The rate of PPM ranged from 2% to 51% in individual studies (with a median of 28% for the Medtronic CoreValve Revalving System [MCRS] and 6% for the Edwards SAPIEN valve [ESV]). The summary estimates indicated increased risk of PPM after TAVR for men (RR: 1.23; p < 0.01); for patients with first-degree AV block (RR: 1.52; p < 0.01), left anterior hemiblock (RR: 1.62; p < 0.01), or right bundle branch block (RR: 2.89; p < 0.01) at baseline; and for patients with intraprocedural AV block (RR: 3.49; p < 0.01). These variables remained significant predictors when only patients treated with the MCRS bioprosthesis were considered. The data for ESV were limited. Unadjusted estimates indicated a 2.5-fold higher risk for PPM implantation for patients who received the MCRS than for those who received the ESV.

Conclusions

Male sex, baseline conduction disturbances, and intraprocedural AV block emerged as predictors of PPM implantation after TAVR. This study provides useful tools to identify high-risk patients and to guide clinical decision making before and after intervention.     

Cardiovascular Outcomes in Patients With Mitochondrial Disease in the United States: A Propensity Score Analysis

Mitochondrial disease comprises a wide range of genetic disorders caused by mitochondrial dysfunction. Its rarity, however, has limited the ability to assess its effects on clinical outcomes. To evaluate this relationship, we collected data from the 2016 National Inpatient Sample, which includes data from >7 million hospital stays. We identified 705 patients (mean age, 22 ± 20.7 yr; 54.2% female; 67.4% white) whose records included the ICD-10-CM code E88.4. We also identified a propensity-matched cohort of 705 patients without mitochondrial disease to examine the effect of mitochondrial disease on major adverse cardiovascular events, including all-cause in-hospital death, cardiac arrest, and acute congestive heart failure.Patients with mitochondrial disease were at significantly greater risk of major adverse cardiovascular events (odds ratio [OR]=2.42; 95% CI, 1.29–4.57; P=0.005), systolic heart failure (OR=2.37; 95% CI, 1.08–5.22; P=0.027), and all-cause in-hospital death (OR=14.22; 95% CI, 1.87–108.45; P<0.001).These findings suggest that mitochondrial disease significantly increases the risk of inpatient major adverse cardiovascular events.     

Long-Term Outcomes After Transcatheter Aortic Valve Replacement in High-Risk Patients With Severe Aortic Stenosis: The U.K. Transcatheter Aortic Valve Implantation Registry

ObjectivesThe U.K. Transcatheter Aortic Valve Implantation Registry reported 30-day and 1-year mortality rates of 7.1% and 21.4%, respectively, for patients who underwent transcatheter aortic valve replacement (TAVR) in the United Kingdom between 2007 and 2009. The study aim was to report long-term outcomes in this same cohort of patients.BackgroundThere are few data on outcomes beyond 3 years after TAVR in any notable number of patients.MethodsData from all TAVR procedures performed in the United Kingdom between January 2007 and December 2009 were prospectively collected. All-cause mortality status was reported in March 2014. Mortality tracking was achieved in 97.7% patients.ResultsThe minimal time from replacement to census was 4.1 years, and the maximal time was 7.0 years. The 3- and 5-year survival rates were 61.2% and 45.5%, respectively. Independent predictors of 3-year mortality were renal dysfunction (hazard ratio [HR]: 1.65), atrial fibrillation (HR: 1.36), logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥18.5 (HR: 1.33), respiratory dysfunction (HR: 1.28), and ventricular dysfunction (left ventricular ejection fraction <30%) (HR: 1.53). Coronary artery disease (HR: 1.28) and age (HR: 1.03) were additional independent predictors of mortality at 5 years. Stroke within 30 days of TAVR was the only independent procedural predictor of mortality at 3 and 5 years (HR: 2.17 at 3 years). Device type, access route, and paravalvular leak did not independently predict long-term outcome.ConclusionsIn the large U.K. Transcatheter Aortic Valve Implantation Registry, long-term outcomes after TAVR are favorable with 3- and 5-year survival rates of 61.2% and 45.5%, respectively. Long-term survival after TAVR is largely determined by intrinsic patient factors. Other than stroke, procedural variables, including paravalvular aortic leak, did not appear to be independent predictors of long-term survival.     

Acute Kidney Injury With the RenalGuard System in Patients Undergoing Transcatheter Aortic Valve Replacement: The PROTECT-TAVI Trial (PROphylactic effecT of furosEmide-induCed diuresis with matched isotonic intravenous hydraTion in Transcatheter Aortic Valve Implantation)

ObjectivesThe purpose of this study was to investigate the effect of the RenalGuard System (PLC Medical Systems, Milford, Massachusetts) on prevention of acute kidney injury (AKI) in patients undergoing transcatheter aortic valve replacement (TAVR).BackgroundTAVR is associated with varying degrees of post-procedural AKI. The RenalGuard System is a dedicated device designed for contrast-induced AKI prevention. Whether this device is also effective in patients with severe aortic stenosis undergoing TAVR is unexplored.MethodsThe present is an investigator-driven, single-center, prospective, open-label, registry-based randomized study that used the TAVR institutional registry of the Ferrarotto Hospital in Catania, Italy, as the platform for randomization, data collection, and follow-up assessment. A total of 112 consecutive patients undergoing TAVR were randomly assigned to hydration with normal saline solution controlled by the RenalGuard system and furosemide (RenalGuard group) or normal saline solution (control group). The primary endpoint was the incidence of Valve Academic Research Consortium–defined AKI in the first 72 h after the procedure.ResultsThe AKI rate was lower in the RenalGuard group than in the control group (n = 3 [5.4%] vs. n =14 [25.0%], respectively, p = 0.014). The majority of patients (5.4% vs. 23.2%) developed a mild AKI (stage 1); severe damage (stage 3) occurred only in 1 patient in the control group (0.0% vs. 1.8%). No case of in-hospital renal failure requiring dialysis was reported. No significant differences in terms of mortality, cerebrovascular events, bleeding, and hospitalization for heart failure were noted in both groups at 30 days.ConclusionsFurosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVR.     

Optimal Implantation Depth and Adherence to Guidelines on Permanent Pacing to Improve the Results of Transcatheter Aortic Valve Replacement With the Medtronic CoreValve System: The CoreValve Prospective,International, Post-Market ADVANCE-II Study

ObjectivesThe aim of the CoreValve prospective, international, post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement with the Medtronic CoreValve System (Minneapolis, Minnesota) using optimized implantation techniques and application of international guidelines on cardiac pacing.BackgroundConduction disturbances are a frequent complication of transcatheter aortic valve replacement. The rates of PPI in the published reports vary according to bioprosthesis type and the indications for PPI.MethodsThe primary endpoint was the 30-day incidence of PPI with Class I/II indications when the Medtronic CoreValve System was implanted at an optimal depth (≤6 mm below the aortic annulus). The timing and resolution of all new-onset conduction disturbances were analyzed.ResultsA total of 194 patients were treated. The overall rate of PPI for Class I/II indications was 18.2%. An optimal depth was reached in 43.2% of patients, with a nonsignificantly lower incidence of PPI in patients with depths ≤6 mm, compared with those with deeper implants (13.3% vs. 21.1%; p = 0.14). In a paired analysis, new-onset left bundle branch block and first-degree atrioventricular block occurred in 45.4% and 39.0% of patients, respectively, and resolved spontaneously within 30 days in 43.2% and 73.9%, respectively. In patients with new PPI, the rate of intrinsic sinus rhythm increased from 25.9% at 7 days to 59.3% at 30 days (p = 0.004).ConclusionsOptimal Medtronic CoreValve System deployment and adherence to international guidelines on cardiac pacing are associated with a lower rate of new PPI after transcatheter aortic valve replacement, compared with results reported in previous studies. (CoreValve Advance-II Study: Prospective International Post-Market Study [ADVANCE II]; NCT01624870)