Permanent Pacemaker Implantation and Long-Term Outcomes of Patients Undergoing Concomitant Mitral and Tricuspid Valve Surgery.

BACKGROUND: Tricuspid valve annuloplasty (TA) during mitral valve repair (MVr) is associated with increased risk of permanent pacemaker (PPM) implantation, but the magnitude of risk and long-term clinical consequences have not been firmly established. OBJECTIVES: This study assesses the incidence rates of PPM implantation after isolated MVr and following MVr with TA as well as the associated long-term clinical consequences of PPM implantation. METHODS: State-mandated hospital discharge databases of New York and California were queried for patients undergoing MVr (isolated or with concomitant TA) between 2004 and 2019. Patients were stratified by whether or not they received a PPM within 90 days of index surgery. After weighting by propensity score, survival, heart failure hospitalizations (HFHs), endocarditis, stroke, and reoperation were compared between patients with or without PPM. RESULTS: A total of 32,736 patients underwent isolated MVr (n = 28,003) or MVr + TA (n = 4,733). Annual MVr + TA volumes increased throughout the study period (P < 0.001, trend), and PPM rates decreased (P < 0.001, trend). The incidence of PPM implantation <90 days after surgery was 7.7% for MVr and 14.0% for MVr + TA. In 90-day conditional landmark-weighted analyses, PPMs were associated with reduced long-term survival among MVr (HR: 1.96; 95% CI: 1.75-2.19; P < 0.001) and MVr + TA recipients (HR: 1.65; 95% CI: 1.28-2.14; P < 0.001). In both surgical groups, PPMs were also associated with an increased risk of HFH (HR: 1.56; 95% CI: 1.27-1.90; P < 0.001) and endocarditis (HR: 1.95; 95% CI: 1.52-2.51; P < 0.001), but not with stroke or reoperation. CONCLUSIONS: Compared to isolated MVr, adding TA to MVr was associated with a higher risk of 90-day PPM implantation. In both surgical groups, PPM implantation was associated with an increase in mortality, HFH, and endocarditis.

Site Variability in Cerebral Embolic Protection for Transcatheter Aortic Valve Implantation and Association With Outcomes.

Background: The effectiveness of cerebral embolic protection devices (CEPD) in mitigating stroke after transcatheter aortic valve implantation (TAVI) remains uncertain, and therefore CEPD may be utilized differently across US hospitals. This study aims to characterize the hospital-level pattern of CEPD use during TAVI in the US and its association with outcomes. Methods: Patients treated with nontransapical TAVI in the 2019 Nationwide Readmissions Database were included. Hospitals were categorized as CEPD non-users and CEPD users. The following outcomes were compared: the composite of in-hospital stroke or transient ischemic attack (TIA), in-hospital ischemic stroke, death, and cost of hospitalization. Logistic regression models were used for risk adjustment of clinical outcomes. Results: Of 41,822 TAVI encounters, CEPD was used in 10.6% (n = 4422). Out of 392 hospitals, 65.8% were CEPD non-user hospitals and 34.2% were CEPD users. No difference was observed between CEPD non-users and CEPD users in the risk of in-hospital stroke or TIA (adjusted odds ratio (OR) = 0.99 [0.86-1.15]), ischemic stroke (adjusted OR = 1.00 [0.85-1.18]), or in-hospital death (adjusted OR = 0.86 [0.71-1.03]). The cost of hospitalization was lower in CEPD non-users. Conclusions: Two-thirds of hospitals in the US do not use CEPD for TAVI, and no significant difference was observed in neurologic outcomes among patients treated at CEPD non-user and CEPD user hospitals.

Feasibility of Coronary Access Following Redo-TAVR for Evolut Failure: A Computed Tomography Simulation Study.

BACKGROUND: Coronary accessibility following redo-transcatheter aortic valve replacement (redo-TAVR) is increasingly important, particularly in younger low-risk patients. This study aimed to predict coronary accessibility after simulated Sapien-3 balloon-expandable valve implantation within an Evolut supra-annular, self-expanding valve using pre-TAVR computed tomography (CT) imaging. METHODS: A total of 219 pre-TAVR CT scans from the Evolut Low-Risk CT substudy were analyzed. Virtual Evolut and Sapien-3 valves were sized using CT-based diameters. Two initial Evolut implant depths were analyzed, 3 and 5 mm. Coronary accessibility was evaluated for 2 Sapien-3 in Evolut implant positions: Sapien-3 outflow at Evolut node 4 and Evolut node 5. RESULTS: With a 3-mm initial Evolut implant depth, suitable coronary access was predicted in 84% of patients with the Sapien-3 outflow at Evolut node 4, and in 31% of cases with the Sapien-3 outflow at Evolut node 5 (P<0.001). Coronary accessibility improved with a 5-mm Evolut implant depth: 97% at node 4 and 65% at node 5 (P<0.001). When comparing 3- to 5-mm Evolut implant depth, sinus sequestration was the lowest with Sapien-3 outflow at Evolut node 4 (13% versus 2%; P<0.001), and the highest at Evolut node 5 (61% versus 32%; P<0.001). CONCLUSIONS: Coronary accessibility after Sapien-3 in Evolut redo-TAVR relates to the initial Evolut implant depth, the Sapien-3 outflow position within the Evolut, and the native annular anatomy. This CT-based quantitative analysis may provide useful information to inform and refine individualized preprocedural CT planning of the initial TAVR and guide lifetime management for future coronary access after redo-TAVR. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02701283.

Transcarotid versus transaxillary access for transcatheter aortic valve replacement with a self-expanding valve: A propensity-matched analysis.

Transaxillary access has been the most frequently used nonfemoral access route for transcatheter aortic valve replacement (TAVR) with a self-expanding valve. Use of transcarotid TAVR is increasing; however, comparative data on these methods are limited. We compared outcomes following transcarotid or transaxillary TAVR with a self-expanding, supra-annular valve. Methods: The Transcatheter Valve Therapy Registry was queried for TAVR procedures using transaxillary and transcarotid access between July 2015 and June 2021. Patients received a self-expanding Evolut R, PRO, or PRO + valve (Medtronic) and had 1-year follow-up. Thirty-day and 1-year outcomes were compared in transcarotid and transaxillary groups after 1:2 propensity score-matching. Multivariable regression models were fitted to identify predictors of key end points. Results: The propensity score-matched cohort included 576 patients receiving transcarotid and 1142 receiving transaxillary access. Median procedure time (99 vs 118 minutes; P < .001) and hospital stay (2 vs 3 days; P < .001) were shorter with transcarotid versus transaxillary access. At 30 days, patients with transcarotid access had similar mortality (Kaplan-Meier estimates 3.7% vs 4.3%, P = .57) but significantly lower stroke (3.1% vs 5.9%; P = .017) and mortality or stroke (6.0% vs 8.9%; P = .033) compared with patients receiving transaxillary access. Similar differences were observed at 1 year. Transaxillary access was associated with increased risk of 30-day stroke (hazard ratio, 2.14; 95% confidence interval, 1.27-3.58) by multivariable regression analysis. Conclusions: Transcarotid versus transaxillary access for TAVR using a self-expanding valve is associated with procedural benefits and significantly lower stroke and mortality or stroke at 30 days. In patients with unsuitable femoral anatomy, transcarotid access may be the preferred delivery route for self-expanding valves.

Percutaneous ventricular assist device for higher-risk percutaneous coronary intervention in surgically ineligible patients: Indications and outcomes from the OPTIMUM study.

BACKGROUND: Indications and outcomes for percutaneous ventricular assist device (pVAD) use in surgically ineligible patients undergoing percutaneous coronary intervention (PCI) remain poorly characterized. AIMS: We sought to describe the use and timing of pVAD and outcome in surgically ineligible patients. METHODS: Among 726 patients enrolled in the prospective OPTIMUM study, clinical and health status outcomes were assessed in patients who underwent pVAD-assisted PCI and those without pVAD. RESULTS: Compared with patients not receiving pVAD (N = 579), those treated with pVAD (N = 142) more likely had heart failure, lower left ventricular ejection fraction (30.7 ± 13.6 vs. 45.9 ± 15.5, p < 0.01), and higher STS 30-day predicted mortality (4.2 [2.1-8.0] vs. 3.3 [1.7-6.6], p = 0.01) and SYNTAX scores (36.1 ± 12.2, vs. 31.5 ± 12.1, p < 0.01). While the pVAD group had higher in-hospital (5.6% vs. 2.2%, p = 0.046), 30-day (9.0% vs. 4.0%, p = 0.01) and 6-month (20.4% vs. 11.7%, p < 0.01) mortality compared to patients without pVAD, this difference appeared to be largely driven by significantly higher mortality among the 20 (14%) patients with unplanned pVAD use (30% in-hospital mortality with unplanned PVAD vs. 1.6% with planned, p < 0.01; 30-day mortality, 38.1% vs. 4.5%, p < 0.01). The degree of 6-month health status improvement among survivors was similar between groups. CONCLUSION: Surgically ineligible patients with pVAD-assisted PCI had more complex baseline characteristics compared with those without pVAD. Higher mortality in the pVAD group appeared to be driven by very poor outcomes by patients with unplanned, rescue pVAD.

Conformational changes during in vitro balloon fracture of internal aortic annuloplasty ring.

Objective: HAART 300 300 (BioStable Science and Engineering, Inc) aortic annuloplasty rings restore physiologic annular geometry during aortic valve repair. Transcatheter valve-in-ring implantation is appealing for recurrent valve dysfunction but may necessitate balloon fracture of downsized annuloplasty rings. We characterized the feasibility of ring fracture and changes in ring geometry preceding fracture. Methods: The 19-mm, 21-mm, and 23-mm HAART 300 annuloplasty rings were obtained, and 23-mm, 24-mm, 25-mm, and 26-mm valvuloplasty balloons were obtained. Under continuous fluoroscopy and video recording, a 23-mm balloon was inflated within a 19-mm ring at 1 atm/s until ring fracture or balloon failure occurred. If balloon failure occurred, experiments were sequentially repeated with 1-mm upsized balloons until ring fracture occurred or no larger-sized balloons were available. Results: Upon balloon inflation, all rings exhibited an irreversible conformational change from an elliptical, annular geometry to a circular shape with ring posts flaring outward. A 23-mm balloon burst at 21 atm without fracturing the 19-mm ring. The 24-mm balloon fractured the 19-mm ring at 15 atm. Likewise, a 24-mm balloon ruptured at 18 atm without fracturing the 21-mm annuloplasty ring. A 25-mm balloon fractured the 21-mm ring at 18 atm. Finally, a 26-mm balloon burst at 20 atm without fracturing a 23-mm annuloplasty ring, but it did elicit the confirmational changes described. All fractures occurred along the upslope of a ring post. The exposed metal frame was visible after the 21-mm ring fracture. Conclusions: Fracture of HAART 300 aortic annuloplasty rings is possible with an oversized, high-pressure balloon. However, the geometrical changes in the ring and subsequent rupture of its fabric covering may be obstacles to safe, in vivo ring fracture.

Bioprosthetic Valve Remodeling in Nonfracturable Surgical Valves: Impact on THV Expansion and Hydrodynamic Performance.

BACKGROUND: There are limited data on the effect of bioprosthetic valve remodeling (BVR) on transcatheter heart valve (THV) expansion and function following valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) in a nonfracturable surgical heart valve (SHV). OBJECTIVES: This study sought to assess the impact of BVR of nonfracturable SHVs on THVs after VIV implantation. METHODS: VIV TAVR was performed using 23-mm SAPIEN3 (S3, Edwards Lifesciences) or 23/26-mm Evolut Pro (Medtronic) THVs implanted in 21/23-mm Trifecta (Abbott Structural Heart) and 21/23-mm Hancock (Medtronic) SHVs with BVR performed with a noncompliant TRUE balloon (Bard Peripheral Vascular Inc). Hydrodynamic assessment was performed, and multimodality imaging including micro-computed tomography was performed before and after BVR to assess THV and SHV expansion. RESULTS: BVR resulted in limited improvement of THV expansion. The largest gain in expansion was observed for the S3 in the 21-mm Trifecta with up to a 12.7% increase in expansion at the outflow of the valve. Minimal change was observed at the level of the sewing ring. The Hancock was less amenable to BVR with lower final expansion dimensions than the Trifecta. BVR also resulted in notable surgical post flaring of up to 17.6°, which was generally more marked with the S3 than with the Evolut Pro. Finally, BVR resulted in very limited improvement in hydrodynamic function. Severe pinwheeling was observed with the S3, which improved slightly but persisted despite BVR. CONCLUSIONS: When performing VIV TAVR inside a Trifecta and Hancock SHV, BVR had a limited impact on THV expansion and resulted in SHV post flaring with unknown consequences on coronary obstruction risk and long-term THV function.

Outcomes of Bioprosthetic Valve Fracture in Patients Undergoing Valve-in-Valve TAVR.

BACKGROUND: Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) is increasingly used to treat degenerated surgical bioprostheses. Bioprosthetic valve fracture (BVF) has been shown to improve hemodynamic status in VIV TAVR in case series. However, the safety and efficacy of BVF are unknown. OBJECTIVES: The primary objective of this study was to assess the safety and efficacy of VIV TAVR using SAPIEN 3 and SAPIEN 3 Ultra valves with or without BVF using data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry. METHODS: The primary outcome was in-hospital mortality. Secondary outcomes included echocardiography-derived valve gradient and aortic valve area. Inverse probability of treatment weighting was used to adjust for baseline characteristics. RESULTS: A total of 2,975 patients underwent VIV TAVR from December 15, 2020, to March 31, 2022. BVF was attempted in 619 patients (21%). In adjusted analyses, attempted BVF was associated with higher in-hospital mortality (OR: 2.51; 95% CI: 1.30-4.84) and life-threatening bleeding (OR: 2.55; 95% CI: 1.44-4.50). At discharge, VIV TAVR with attempted BVF was associated with larger aortic valve area (1.6 cm2 vs 1.4 cm2; P < 0.01) and lower mean gradient (16.3 mm Hg vs 19.2 mm Hg; P < 0.01). When BVF was compared with no BVF according to timing (before vs after transcatheter heart valve implantation), BVF after transcatheter heart valve implantation was associated with improved hemodynamic status and similar mortality. CONCLUSIONS: BVF as an adjunct to VIV TAVR with the SAPIEN 3 and SAPIEN 3 Ultra valves is associated with a higher risk for in-hospital mortality and significant bleeding and modest improvements in echocardiography-derived hemodynamic status. The timing of BVF is an important determinant of safety and efficacy.

Outcomes of Medical Therapy Plus PCI for Multivessel or Left Main CAD Ineligible for Surgery.

BACKGROUND: Percutaneous coronary intervention (PCI) is increasingly used to revascularize patients ineligible for CABG, but few studies describe these patients and their outcomes. OBJECTIVES: This study sought to describe characteristics, utility of risk prediction, and outcomes of patients with left main or multivessel coronary artery disease ineligible for coronary bypass grafting (CABG). METHODS: Patients with complex coronary artery disease ineligible for CABG were enrolled in a prospective registry of medical therapy + PCI. Angiograms were evaluated by an independent core laboratory. Observed-to-expected 30-day mortality ratios were calculated using The Society for Thoracic Surgeons (STS) and EuroSCORE (European System for Cardiac Operative Risk Evaluation) II scores, surgeon-estimated 30-day mortality, and the National Cardiovascular Data Registry (NCDR) CathPCI model. Health status was assessed at baseline, 1 month, and 6 months. RESULTS: A total of 726 patients were enrolled from 22 programs. The mean SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score was 32.4 ± 12.2 before and 15.0 ± 11.7 after PCI. All-cause mortality was 5.6% at 30 days and 12.3% at 6 months. Observed-to-expected mortality ratios were 1.06 (95% CI: 0.71-1.36) with The Society for Thoracic Surgeons score, 0.99 (95% CI: 0.71-1.27) with the EuroSCORE II, 0.59 (95% CI: 0.42-0.77) using cardiac surgeons' estimates, and 4.46 (95% CI: 2.35-7.99) using the NCDR CathPCI score. Health status improved significantly from baseline to 6 months: SAQ summary score (65.9 ± 22.5 vs 86.5 ± 15.1; P < 0.0001), Kansas City Cardiomyopathy Questionnaire summary score (54.1 ± 27.2 vs 82.6 ± 19.7; P < 0.0001). CONCLUSIONS: Patients ineligible for CABG who undergo PCI have complex clinical profiles and high disease burden. Following PCI, short-term mortality is considerably lower than surgeons' estimates, similar to surgical risk model predictions but is over 4-fold higher than estimated by the NCDR CathPCI model. Patients' health status improved significantly through 6 months.

Timing of bioprosthetic valve fracture in transcatheter valve-in-valve intervention: impact on valve durability and leaflet integrity.

BACKGROUND: Bioprosthetic valve fracture (BVF) can be used to improve transcatheter heart valve (THV) haemodynamics following a valve-in-valve (ViV) intervention. However, whether BVF should be performed before or after THV deployment and the implications on durability are unknown.  Aims: We sought to assess the impact of BVF timing on long-term THV durability. METHODS: The impact of BVF timing was assessed using small ACURATE neo (ACn) or 23 mm SAPIEN 3 (S3) THV deployed in 21 mm Mitroflow valves compared to no-BVF controls. Valves underwent accelerated wear testing up to 200 million (M) cycles (equivalent to 5 years). At 200M cycles, THV were evaluated by hydrodynamic testing, second-harmonic generation (SHG) microscopy, scanning electron microscopy (SEM) and histology. RESULTS: At 200M cycles, the regurgitant fraction (RF) and effective orifice area (EOA) for the ACn were 8.03±0.30%/1.74±0.01 cm2 (no BVF), 12.48±0.70%/1.97±0.02 cm2 (BVF before ViV) and 9.29±0.38%/2.21±0.0 cm2 (BVF after ViV), respectively. For the S3 these values were 2.63±0.51%/1.26±0.01 cm2, 2.03±0.42%/1.65±0.01 cm2, and 1.62±0.38%/2.22±0.01 cm2, respectively. Further, SHG and SEM revealed a higher degree of superficial leaflet damage when BVF was performed after ViV for the ACn and S3. However, the histological analysis revealed significantly less damage, as determined by matrix density analysis, through the entire leaflet thickness when BVF was performed after ViV with the S3 and a similar but non-significant trend with the ACn.  Conclusions: BVF performed after ViV appears to offer superior long-term EOA without increased RF. Ultrastructure leaflet analysis reveals that the timing of BVF can differentially impact leaflets, with more superficial damage but greater preservation of overall leaflet structure when BVF is performed after ViV.

The Outcomes of Percutaneous RevascularizaTIon for Management of SUrgically Ineligible Patients With Multivessel or Left Main Coronary Artery Disease (OPTIMUM) Registry: Rationale and Design.

BACKGROUND: Guidelines endorse coronary artery bypass as the preferred revascularization strategy for patients with left main and/or multivessel coronary artery disease (CAD). However, many patients are deemed excessively high risk for surgery after Heart Team evaluation. No prospective studies have examined contemporary treatment patterns, rationale for surgical decision-making, completeness of revascularization with percutaneous coronary intervention (PCI), and outcomes in this high-risk population with advanced CAD. METHODS: We designed the Outcomes of Percutaneous RevascularizaTIon for Management of SUrgically Ineligible Patients with Multivessel or Left Main Coronary Artery Disease (OPTIMUM) registry, a prospective, multicenter study of patients with "surgical anatomy" determined to be at prohibitive risk for bypass surgery. The primary outcome is comparison of observed to predicted 30-day mortality, with secondary outcomes of patient-reported health status and the association between completeness of revascularization and clinical outcomes. Patient characteristics driving surgical risk determinations will be reported, and peri-operative risk will be assessed using validated scoring methods. Angiograms will be assessed by an independent core laboratory, and clinical events will be adjudicated. RESULTS: Clinical outcomes assessments will include 30-day and 1-year cardiovascular events, health status at 1, 6 and 12-months, and 5-year mortality. CONCLUSIONS: OPTIMUM is the first prospective, multicenter study to examine treatment strategies and outcomes among multivessel CAD patients deemed ineligible for surgical revascularization after Heart Team assessment. This registry will provide unique insights into the clinical decision-making, revascularization practices, safety, effectiveness, and health status outcomes in this high-risk population.

Implications of Payment for Acute Myocardial Infarctions as a 90-Day Bundled Single Episode of Care: A Cost of Illness Analysis.

OBJECTIVES: Evaluate the cost of illness associated with the 90-day period following acute myocardial infarction (AMI) and the implication of care pathway (percutaneous coronary intervention [PCI] vs medical management [MM]), in order to assess the potential financial risk incurred by providers for AMI as an episode of care. PERSPECTIVE: Reimbursement payment systems for acute care episodes are shifting from 30-day to 90-day bundled payment models. Since follow-up care and readmissions beyond the early days/weeks post-AMI are common, financial risk may be transferred to providers. SETTING: AMI hospitalization Centers for Medicare & Medicaid Services (CMS) standard analytical files between 10/1/2015 and 9/30/2016 were reviewed. METHODS: Included patients were Medicare beneficiaries with a primary diagnosis of AMI subsequently treated with either PCI or MM. Payments were standardized to remove geographic variation and separated into reimbursements for services during the hospitalization and from discharge to 90 days post-discharge. Results were stratified by Medicare Severity Diagnosis Related Groups (MS-DRGs) individually and grouped between patients treated with MM and PCI. Risk-adjusted likelihood of utilization of post-acute nursing care and all-cause readmission was assessed by logistic regression. RESULTS: A total of 96,546 patients were included in the analysis. The highest total mean payment (US$32,714) was for MS-DRG 248 (PCI with non-drug-eluting stent with major complication or comorbidity). Total payments were similar between MM and PCI patients, but MM patients incurred the majority of costs in the post-acute period after discharge, with the converse true for PCI patients. MM without catheterization was associated with a twofold increase in risk of requiring post-acute nursing care and 90-day readmission versus PCI (odds ratio [95% confidence interval]: 2.01 [1.92-2.11] and 2.17 [2.08-2.27]). Smaller hospital size, diabetes, peripheral arterial disease, prior AMI, and multivessel disease were predictors of higher healthcare utilization. CONCLUSIONS: MS-DRGs associated with the lowest reimbursements (and presumably, lowest costs of inpatient care) incur the highest post-discharge expenditures. As the CMS Bundled Payment for Care Improvement and similar programs are implemented, there will be a need to account for heterogeneous post-discharge care costs. Video abstract (MP4 274659 KB).

Around 805,000 heart attacks occur annually in the US. With an average age over 65 years, many heart attack patients qualify for Medicare health insurance. Under Medicare, hospitals (or 'providers') receive reimbursements for the cost of care associated with 'acute care episodes' (e.g., heart attacks) as a 'bundled' payment. The bundled reimbursements are typically based on pre-defined prices, with hospitals paying the difference if actual costs exceed these. Reimbursements are typically given for care costs from the initial heart attack through to hospital discharge and care in the 30-day post-discharge period. However, recently introduced reimbursement models such as BPCI Advanced have moved to expand this to 90 days. Since follow-up care and additional cardiovascular readmissions are common beyond 30 days, extension of the reimbursement period to 90 days could increase financial risk to hospitals/providers if these additional costs are not included in reimbursements. To assess the potential impact of this, we investigated the cost of illness for heart attack and the implication of type of care: medical management (standard medication given after heart attack) vs. percutaneous coronary intervention (PCI; standard medication plus a non-surgical procedure to widen heart blood vessels). We found that 90-day costs after heart attack are substantial regardless of type of care. We found that post-discharge costs were generally high, but higher for medically managed patients than those receiving PCI. Our analysis also suggests Medicare disease classifications associated with lowest payments for heart attack (and presumably, lowest hospitalization costs) are associated with the highest post-discharge expenditures. Overall, our study suggests that new payment models should account for variable post-discharge care costs, and new therapies are needed to reduce additional events, readmissions, and associated costs in heart attack patients.

Network Meta-Analysis Comparing the Short- and Long-Term Outcomes of Alternative Access for Transcatheter Aortic Valve Replacement.

BACKGROUND: Several studies have pair-wise compared access sites for transcatheter aortic valve replacement (TAVR) but pooled estimate of overall comparative efficacy and safety outcomes are not well known. We sought to compare short- and long-term outcomes following various alternative access routes for TAVR. METHODS: Thirty-four studies with a pooled sample size of 32,756 patients were selected by searching PubMed and Cochrane library databases from inception through 11th June 2021 for patients undergoing TAVR via 1 of 6 different access sites: Transfemoral (TF), Transaortic (TAO), Transapical (TA), Transcarotid (TC), Transaxillary/Subclavian (TSA), and Transcaval (TCV). Data were extracted to conduct a frequentist network meta-analysis with a random-effects model using TF access as a reference group. RESULTS: Compared with TF, both TAO [RR 1.91, 95% CI (1.46-2.50)] and TA access [RR 2.12, 95% CI (1.84-2.46)] were associated with an increased risk of 30-day mortality. No significant difference was observed for stroke, myocardial infarction, major bleeding, conversion to open surgery, and major adverse cardiovascular or cerebrovascular events at 30 days between different accesses. Major vascular complications were lower in TA [RR 0.43, (95% CI, 0.28-0.67)] and TC [RR 0.51, 95% CI (0.35-0.73)] access compared to TF. The 1-year mortality was higher in TAO [RR of 1.35, (95% CI, 1.01-1.81)] and TA [RR 1.44, (95% CI, 1.14-1.81)] groups. CONCLUSION: Non-thoracic alternative access site utilization for TAVR implantation (TC, TSA and TCV) is associated with outcomes similar to conventional TF access. Thoracic TAVR access (TAO and TA) translates into increased short and long-term mortality.

Transcarotid versus transthoracic access for transcatheter aortic valve replacement: A propensity-matched analysis.

OBJECTIVE: Transcarotid access for transcatheter aortic valve replacement is emerging as an alternative to more traditional nonfemoral access options such as transapical or transaortic; however, comparative data are limited. The purpose of the study was to analyze outcomes after transcatheter aortic valve replacement using transcatheter compared with transthoracic (transapical/transaortic) access. METHODS: The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry was queried for patients who underwent transcarotid, transapical, or transaortic transcatheter aortic valve replacement with the SAPIEN 3 (Edwards Lifesciences, Irvine, Calif) transcatheter heart valve between June 2015 and July 2019. Thirty-day unadjusted outcomes were evaluated, and propensity score matching and logistic regression were used to compare transcatheter access with transthoracic access. RESULTS: In the propensity-matched analysis, 667 transcarotid transcatheter aortic valve replacement procedures were compared with 1334 transthoracic procedures. Transcarotid transcatheter aortic valve replacement was associated with lower mortality (4.2% vs 7.7%, P = .004), less new-onset atrial fibrillation (2.2% vs 12.1%, P < .0001), fewer readmissions at 30 days (9.8% vs 16.1%, P = .0006), shorter median length of stay (3.0 vs 6.0 days, P < .0001), shorter median intensive care unit stay (25 vs 47.2 hours, P < .0001), and greater 30-day Kansas City Cardiomyopathy Questionnaire score improvement from baseline (25.1 vs 20.8, P = .007). Stroke (4.3% vs 3.7%, P = .44) and major vascular complications (1.4% vs 1.9%, P = .40) were similar. CONCLUSIONS: Transcatheter aortic valve replacement using transcarotid access is associated with lower 30-day mortality, less atrial fibrillation, shorter intensive care unit and overall length of stay, fewer readmissions, greater improvement in Kansas City Cardiomyopathy Questionnaire scores, and no significant difference in stroke or major vascular complications compared with transthoracic access.

Bioprosthetic valve fracture: a practical guide.

Valve-in-valve transcatheter aortic valve replacement (VIV TAVR) is currently indicated for the treatment of failed surgical tissue valves in patients determined to be at high surgical risk for re-operative surgical valve replacement. VIV TAVR, however, often results in suboptimal expansion of the transcatheter heart valve (THV) and can result in patient-prosthesis mismatch (PPM), particularly in small surgical valves. Bioprosthetic valve fracture (BVF) and bioprosthetic valve remodeling (BVR) can facilitate VIV TAVR by optimally expanding the THV and reducing the residual transvalvular gradient by utilizing a high-pressure inflation with a non-compliant balloon to either fracture or stretch the surgical valve ring, respectively. This article, along with the supplemental video, will provide patient selection, procedural planning and technical insights for performing BVF and BVR.