The Valve Wire sealThe Valve Wire
July 14, 2026E. Nolan Beckett, MD · Editor
The Valve Wire Weekly Podcast
This Week’s Podcast
The Valve Wire Weekly - 2026-07-11
19:08 listen · 2026-07-11
Listen Now →
From the Editor
Hospital TAVR volume drives complication rates, not the ability to rescue patients once complications occur — a STS/ACC TVT Registry analysis of 487,159 TAVR patients across 808 sites in JACC Cardiovascular Interventions found lowest-quartile centers had 19% higher major complication odds (aOR 1.19) but statistically identical failure-to-rescue rates (~11%) versus top-quartile centers. Meanwhile, a meta-analysis of 4,828 patients showed Abbott's Navitor tripled moderate-to-severe paravalvular leak (RR 3.36) and doubled pacemaker rates versus SAPIEN, and the FDA logged its most serious recall class for Medtronic's Harmony pulmonary valve delivery catheter over tip detachment risk. Edwards separately agreed to a record $10M HSR settlement tied to its JC Medical acquisition, complicating the low-risk TAVR narrative on both device and corporate axes. Volume-outcome curve in TAVR reflects who avoids complications, not who rescues them — center selection matters most upstream (JACC CV Interv). Navitor vs SAPIEN meta-analysis: Navitor tripled moderate-severe PVL and doubled PPI, but reduced patient-prosthesis mismatch (Cureus). FDA Class I recall on Medtronic Harmony pulmonary valve delivery catheter for distal tip detachment risk during implant (FDA MedWatch). Sublingual nitroglycerin before pre-TAVI CCTA was safe in 109 severe AS patients and improved diagnostic accuracy from 67.6% to 84.9% (TCTMD/SCCT 2026). CALLY inflammatory-nutritional index stratified 30-day AKI risk in 816 TAVR patients (aHR 0.50 top vs bottom tertile) (Cath Cardiovasc Interv). What to watch: Edwards Q2 earnings on July 23 will test whether the FTC settlement and low-risk expansion narrative move guidance on the $10B TAVR franchise.
E. Nolan Beckett, MD · Editor
Read the Full Editorial →
The Weekly · 3 days ago

The Valve Wire Weekly — 2026-07-11

Read the Full Weekly →

Aortic Valve (TAVR/TAVI)

31 articles

The volume-outcome debate in TAVR just shifted from "get more reps" to "prevent the complication in the first place." The STS/ACC TVT Registry analysis of 487,159 patients across 808 US sites (2017–2023) found bottom-quartile centers had 12% higher 30-day mortality (aOR 1.12) and 19% higher major complication rates than top-quartile centers, but failure-to-rescue was flat at ~11% across all volume strata. The editorial companion framed this as "complications, not rescue" — meaning the CMS volume threshold debate should focus on procedural technique, patient selection, and CT planning, not ICU heroics after things go wrong.

Two adjunct findings sharpen the picture. A Cureus meta-analysis of 4,828 patients (four studies, all non-randomized) found Abbott's Navitor self-expandable valve tripled moderate-to-severe PVL versus SAPIEN (RR 3.36) and doubled permanent pacemaker rates (RR 2.16), while cutting patient-prosthesis mismatch nearly in half (RR 0.55) — a hemodynamic-versus-complication tradeoff the guidelines don't yet address. And a JACC CV Interv position statement formalized the "TAVR CODE" framework (coaxiality, orientation, depth, expansion) to standardize implantation and preserve future valve-in-valve options — directly relevant to the ESC 2025 lifetime management push for patients ≥70. Surgical counterpoint: ACC/AHA 2020 still favors SAVR for patients <65 on durability grounds, and ESC 2025 raised that floor to <70 with low surgical risk (STS-PROM + EuroSCORE II <4%). The Navitor PVL and pacemaker signals reinforce why.

Additional items: sublingual nitroglycerin before pre-TAVI CCTA (single-center prospective, N=109) improved diagnostic accuracy from 67.6% to 84.9% and cut equivocal CAD-RADS 3 scans, challenging a long-standing SCCT contraindication. The CALLY index (C-reactive protein–albumin–lymphocyte, single-center retrospective, N=816) identified TAVR patients at 30-day AKI risk (aHR 0.50 high vs low tertile) — a useful frailty proxy but derivation-only. And a JACC CV Interv case report described a "double-seal" occluder + TAV-in-TAV strategy for post-TAVR aortic-root-to-RV fistula, a reminder that late TAVR complications are creating a new bailout catalog.


Abbreviated DAPT Regimens Across the Entire Spectrum of Bleeding Risk According to the PRECISE-HBR Score.

BACKGROUND: Among high-bleeding risk (HBR) patients undergoing coronary stenting, abbreviated dual antiplatelet therapy (DAPT) reduces bleeding without ischemic risk trade-off; whether these benefits persist across the entire spectrum of bleeding risk has not been investigated. OBJECTIVES: The aim of this study is to explore the value of the novel PRECISE-HBR score as a risk stratification tool to guide DAPT duration in patients at high bleeding risk. METHODS: The XIENCE Short DAPT program combined 3 international single-arm studies of HBR patients treated with cobalt-chromium everolimus-eluting stents who discontinued DAPT at 1 month (XIENCE 28 USA/Global) or 3 months (XIENCE 90), if event free and treatment adherent. Bleeding risk was classified as nonhigh (PRECISE-HBR score ≤22), high (score 23-26), or very high (score ≥27). Clinical outcomes were assessed between 1 and 12 months using propensity score stratification. RESULTS: Among 3,364 patients, the PRECISE-HBR score was ≤22, 23-26, and ≥27 in 359 (10.7%), 744 (22.1%), and 2,261 (67.2%), respectively. Rates of BARC (Bleeding Academic Research Consortium) type 3-5 bleeding (0.3%, 2.5%, 5.6%) and death or myocardial infarction (2.9%, 4.6%, 9.8%) increased progressively across risk categories. One- versus 3-month DAPT was associated with a significant reduction in BARC type 3-5 bleeding in patients with a score ≥27 (HR: 0.59, 95% CI: 0.39-0.88) but not in those <27 (HR: 2.31, 95% CI: 0.89-5.99; P-interaction = 0.012). Ischemic risk was similar between 1- and 3-month DAPT, irrespective of the PRECISE-HBR score (P-interaction = 0.40). CONCLUSIONS: The PRECISE-HBR score identified patients at increased risk for both bleeding and ischemic events who seemed to derive greater benefit from 1-month DAPT after stent implantation.

Hospital Volume and Failure to Rescue Post-TAVR: Insights From the STS/ACC TVT Registry.

BACKGROUND: There is an inverse volume-mortality relationship for transcatheter aortic valve replacement (TAVR), with higher adjusted mortality among hospitals with lower TAVR volumes. OBJECTIVES: The aim of this study was to identify potential mediators of the volume-mortality relationship including the risk of major complications occurring and/or failure to rescue (FTR) from these complications. METHODS: Using the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, we identified patients who underwent TAVR from 2017 to 2023. The rate of FTR-defined as 30-day risk-adjusted mortality following a major complication post TAVR-was compared across hospitals stratified by quartiles (Q1-Q4) of annualized TAVR volume. RESULTS: A total of 487,159 patients (median age: 79 years, 57% male) who underwent TAVR across 808 sites were included. Lower-volume centers (Q1) had significantly higher rates of 30-day mortality (adjusted OR: 1.12; 95% CI: 1.00-1.25; P = 0.045) and major complications (adjusted OR: 1.19; 95% CI: 1.08-1.32; P = 0.0006) than higher-volume centers (Q4). The overall rate of FTR across all hospitals was 11.0%. There were no significant differences in FTR rates by hospital volume (adjusted OR: 0.97 per 100 cases; 95% CI: 0.93-1.01; P = 0.11) and no evidence of a threshold relationship. CONCLUSIONS: In this large contemporary study, we found that higher annualized TAVR volume was associated with lower complication rates but not with lower FTR rates. These findings suggest that the inverse relationship between hospital TAVR volume and post-TAVR mortality may be more strongly associated with complication rates than with FTR.

Procedural Strategies for Optimal Transcatheter Aortic Valve Replacement: An International Position Statement.

The extension of transcatheter aortic valve replacement (TAVR) to younger patients with longer life expectancy has driven a shift in focus toward procedural optimization, with the goals of maximal clinical improvement, durable outcomes, maintained coronary access, and avoidance of permanent pacemaker implantation. A TAVR CODE framework including 4 key fluoroscopic parameters-coaxiality, orientation, depth, and expansion-has recently been proposed to standardize the intraprocedural evaluation of optimal transcatheter heart valve (THV) implantation. Systematic implementation of these concepts during TAVR is expected to improve valve performance and durability. This is hypothesized to improve afterload reduction, enhance left ventricular reverse remodeling, and confer increased and longer lasting clinical benefits. To date, procedural strategies to optimize TAVR outcomes have been largely based upon expert opinion, supported predominantly by mechanistic and retrospective studies. Ongoing randomized trials are evaluating the effects of systematic pre- and postdilatation during TAVR, the impact of same-volume double-tap techniques with balloon-expandable valves, and the effectiveness of different commissural alignment techniques. Meanwhile, intravascular ultrasound is under investigation as a tool to evaluate THV expansion to guide postdilatation, while technical consistency may be improved by innovative THV designs that promote symmetrical expansion, better fluoroscopic visualization, and robotic insertion systems using artificial intelligence. In this article, we detail the possible impact of implementing the TAVR CODE framework on THV function, durability, and clinical outcomes, and provide an expert perspective on procedural strategies to achieve optimal index TAVR outcomes, including management frameworks and position statements according to contemporary best practices.

Impact of Coronary Microvascular Dysfunction on Patient-Reported Symptoms After PCI.

BACKGROUND: Coronary microvascular dysfunction (CMD) has been proposed as a mechanism underlying residual angina after percutaneous coronary intervention (PCI). OBJECTIVES: The objective of the study was to investigate the impact of CMD on symptoms in patients undergoing PCI. METHODS: Patients with hemodynamically significant coronary artery disease (CAD) (fractional flow reserve ≤0.80) were included. CAD was classified as focal or diffuse using the pull back pressure gradient (PPG) (diffuse CAD defined as PPG <0.62). CMD was defined as microvascular resistance reserve <3.0. The Seattle Angina Questionnaire (SAQ) was administered at baseline and 1 year. RESULTS: Among 201 patients (mean age 68.5 ± 10.1 years; 71% male), CMD was present in 75 (37.3%), with no difference between focal and diffuse CAD (41% vs 34%; P = 0.35). At baseline, CMD was associated with more severe symptoms without reaching statistical significance (SAQ summary score 64.0 ± 25.3 vs 69.6 ± 21.0; P = 0.09). At 1 year, symptoms were similar between groups (SAQ summary score 87.6 ± 16.0 vs 89.4 ± 16.4; P = 0.47). A significant interaction between PPG and microvascular resistance reserve was observed for residual angina (P for interaction = 0.015); patients with focal CAD and concomitant CMD had the highest burden of residual symptoms. CONCLUSIONS: CMD is present in approximately one-third of patients undergoing PCI and occurs with similar frequency in focal and diffuse CAD. CMD alone was not associated with residual angina. However, its clinical relevance varied according to the epicardial disease pattern: in focal CAD, concomitant CMD was associated with less symptomatic improvement after PCI, whereas in diffuse CAD, residual symptoms appeared to be driven predominantly by persistent epicardial disease.

View all 31 Aortic Valve articles →

Surgical vs Transcatheter

5 articles

Popular media surfaced a seven-year TAVR-vs-SAVR narrative claiming transcatheter equivalence on durability. The underlying data (unspecified in the coverage) sits within the same evidentiary frame flagged in recent JACC editorials on "indication creep": intermediate-risk trials pooled with low-risk trials generate composite hazard reductions that don't survive when stratified. Meta-analyses have shown a mortality signal favoring TAVR at 5 years in lower-risk patients (HR 0.80), but the signal disappears when intermediate-risk cohorts are excluded — and no RCT has reported durable ≥10-year TAVR outcomes in patients <65. ACC/AHA 2020 (SAVR preferred <65) and ESC 2025 (SAVR preferred <70 with low surgical risk) both hold this line. A separate Turkish single-center retrospective comparing robot-assisted vs transcatheter ASD closure (N=635) found longer procedural times but lower post-procedural TR with robotic surgery (3.2% device migration in transcatheter arm) — a reminder that shunt closure and valve replacement live on different risk curves.


Left Internal Jugular Vein Access for Mitral Transcatheter Edge-to-Edge Repair: A Case Report and Review of Literature for Alternative Venous Access Routes.

BACKGROUND: The increasing indications of transcatheter edge-to-edge repair (TEER) have led to its use in more diverse populations, including patients with complex comorbidities where standard transfemoral access may not be feasible. In these cases, utilizing the right internal jugular vein (IJV) access has been reported as a safe and practical alternative route. Herein, we report the first case of mitral TEER via left IJV access, using PASCAL system. CASE PRESENTATION: A 50-year-old woman with long-standing chronic kidney disease and two previously failed renal transplants suffered repeated admissions for acute pulmonary edema. Echocardiography confirmed severe functional mitral regurgitation (MR) and global left ventricular systolic dysfunction. Due to extremely high surgical risk, the multidisciplinary heart team opted for mitral TEER. Unexpectedly, pre-procedural imaging demonstrated complete occlusion of the inferior vena cava with prominent collateral circulation and total occlusion of the right IJV. After extensive team discussion, access via the left IJV was selected. Transseptal puncture (TSP) was performed with the VersaCross radiofrequency system, the septum was dilated using a 6 mm Mustang balloon, and a PASCAL P10 device was successfully implanted between the A2 and P2 segments, resulting in reduction of MR severity from severe (4+) to mild (1+). The procedure concluded without complications and hemostasis was secured. At 2-month follow-up the patient remained stable with no recurrent decompensations. CONCLUSION: Left IJV is a feasible alternative access for mitral-TEER when other venous accesses are not feasible. Proper pre-procedural planning and local expertise is essential to overcome the technical challenges related to TSP and steering the guiding catheter against the complex anatomical orientation of the left innominate vein.

Comparison of robot-assisted surgical and transcatheter closure of secundum atrial septal defect: A single-center retrospective study.

BACKGROUND: Atrial septal defect (ASD) closure can be performed using either transcatheter or robot-assisted surgical approaches. This study aimed to compare the clinical outcomes, procedural characteristics, and complications associated with these two techniques in a large patient cohort. METHODS: A retrospective analysis was conducted on 635 patients who underwent ASD closure via either robot-assisted surgery (Group I, n=290) or transcatheter closure (Group II, n=345). Preoperative, perioperative, and postoperative data, including procedural times, complications, and follow-up outcomes, were evaluated. In addition, patients treated after 2019 were analyzed as a subgroup and categorized as Group Is (robot-assisted surgery, n=101) and Group IIs (transcatheter closure, n=105). RESULTS: Patients in Group I had significantly longer procedural times and hospital stays than those in Group II (p<0.001). Postoperative tricuspid regurgitation was more frequent in the transcatheter group (p=0.003). Device migration occurred in 3.2% of transcatheter cases. Overall neurological events occurred in 0.7% of Group I patients and 2.6% of Group II patients (p=0.06). No significant difference in postoperative arrhythmia rates was observed between the groups. In the subgroup analysis of patients treated after 2019, the mean hospital stay was 2.36±0.5 days in Group Is and 2.21±0.6 days in Group IIs (p=0.07). Ventilation time was 3.6±1.4 hours versus 3.1±1.9 hours (p=0.05), and intensive care unit stay was 7.8±2.9 hours versus 7.2±3.0 hours (p=0.20), respectively. CONCLUSION: Both transcatheter and robot-assisted surgical ASD closure are safe and effective when patients are appropriately selected. Robot-assisted surgery offers the additional advantage of concomitant tricuspid valve annuloplasty and demonstrates improved outcomes with increasing surgical experience. Larger prospective multicenter studies are needed to further validate these findings.

Mitral Valve (Repair & Replacement)

5 articles

Access innovation, not new evidence, defines today's mitral story. A case report in Catheter Cardiovasc Interv described the first mitral TEER via left internal jugular vein using PASCAL P10, in a 50-year-old with occluded IVC and right IJV from prior renal transplants — MR reduced from 4+ to 1+, patient stable at 2 months. Single case, single center, but relevant as TEER indications expand into anatomically complex populations under both ACC/AHA 2020 (Class IIa for high-risk primary MR) and the ESC 2025 upgrade of TEER to Class I for ventricular secondary MR.

Surgical counterpoint: Neither guideline supports TEER as first-line for primary MR when durable surgical repair is feasible — repair remains Class I in both, and ESC 2025 upgraded early surgical repair in asymptomatic primary MR with adverse features (AF, PH, LA dilation, ≥moderate TR) from IIa to Class I. Access creativity is not an argument for expanded transcatheter indications; it's an argument for referring inoperable patients earlier before venous anatomy deteriorates.


Tricuspid Valve (Repair & Replacement)

5 articles

No dedicated tricuspid randomized data today, but the ESC 2025 Class IIa recommendation for transcatheter TV treatment in high-risk symptomatic severe TR sits against a still-thin evidence base dominated by TRILUMINATE, Tri.Fr, and TRISCEND II. The Medtronic Harmony pulmonary valve Class I recall — distal tip detachment during delivery — is a right-heart cautionary tale, even though it's a delivery catheter issue on the pulmonary side, not the tricuspid platform. Surgical counterpoint: ESC 2025 upgraded surgery for symptomatic severe primary TR to Class I; the too-late-referral problem remains the field's central issue regardless of whether the eventual intervention is surgical or transcatheter.


Regulatory & Policy

5 articles

[NOTABLE] The FDA classified Medtronic's Harmony Delivery Catheter System recall at its highest severity — risk of distal tip detachment during implant requiring secondary retrieval or surgical intervention. Medtronic sent field letters May 28 and has not reported serious injuries or deaths to date. Successfully implanted Harmony TPV patients require no additional action. The recall targets the delivery catheter, not the valve, but for a device already competing in a small congenital/RVOT market against SAPIEN pulmonary applications, it's a commercial and clinical headwind.


Trials to Watch

Full trial tracker →

Curated landmark trials. Full tracker for every monitored study.

+5 more landmark trials on the tracker.

Daily digest. ~3-minute read.
Free while we’re launching. Independent. No industry funding. No spam, never sold.