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Home › Archive › Thursday, October 15, 2026Daily edition · Vol. 1, No. 1

Thursday, October 15, 2026

E. Nolan Beckett, MD74 items covered

Executive Summary

Acute normovolemic hemodilution does not spare women from transfusion, and it hurts them: in a secondary analysis of the 2,010-patient ANH trial covering its 405 female participants, red cell transfusion rates were statistically identical (38.8% vs 44.6%), while intraoperative hypotension tripled (16.0% vs 4.8%) and both ICU and hospital stays ran longer. The accompanying JAMA Surgery commentary lands on the same point: the subgroup with the highest transfusion burden is the one where the technique performs worst. Separately, a Danish register study of 19,080 patients after MI, PCI, or CABG showed that moving cardiac rehabilitation into municipalities raised uptake 16% and cut both distance-based and education-based inequality, a bigger survival lever than most intraoperative blood-conservation tweaks. Together these tighten the case for abandoning routine ANH in women and loosening the grip of hospital-centric rehab delivery.

  • NIRS-guided intraoperative management probably reduces early postoperative cognitive decline (RR 0.65), pooled across 17 RCTs and 2,288 patients, moderate certainty only.
  • FDA issued an early alert after three Edwards Commander M mitral delivery balloons burst, with one reported death and one serious injury, four lots pulled.
  • Intraoperative hemoadsorption during endocarditis surgery halved vasoplegia and cut 30-day mortality to 7.5% from 20.5%, non-randomized, 176 patients.
  • Japan's national LVAD registry reports 5-year survival of 84% in the HeartMate 3 era versus 76% before, 1,859 patients.
  • Single-ventricle anatomy drops one-year survival after TAPVC repair to 52% versus 88% with biventricular anatomy, 1,258 infants, 10 years, multicenter.

What to watch: Whether the FDA escalates the Edwards Commander M early alert to a formal recall classification before Edwards reports third-quarter structural heart results on November 4.


Coronary Surgery

The coronary story today is physiology, not grafts. Continuous thermodilution in 51 patients with anomalous aortic origin of a coronary artery showed that the high-risk anatomic triad (intramural segment, acute take-off, slit-like ostium) produces measurably reduced hyperemic flow (179 vs 290 mL/min) and elevated microvascular resistance at rest and under stress. That matters because surgical unroofing has been justified almost entirely by anatomy and sudden-death registries, never by randomized data. A flow-based threshold would give AAOCA surgery something it has lacked: a physiologic trigger. The study is prospective but small, single-center, and uses non-anomalous vessels as controls rather than a matched population.

On the rehabilitation side, the Danish decentralization cohort is the most actionable coronary finding of the day: among the 20% of patients living farthest from a rehab facility, uptake rose 45%. ACC/AHA and ESC both give cardiac rehab a Class I recommendation after CABG, and surgical programs still discharge patients into systems that make attendance a logistics problem. Minimally invasive CABG continues to get lay coverage, including a feature in The Star, well ahead of any randomized comparison with sternotomy.


Aortic Surgery

Preoperative anticoagulation in acute type A dissection remains an unsolved management problem, and the field is still arguing it in commentary rather than trials. Snyder and Mehaffey, writing in Annals of Thoracic Surgery, take up the question of how DOAC and antiplatelet exposure should modify operative timing and reversal strategy. There is no randomized evidence here and there will not be; the practical answer runs through andexanet and idarucizumab availability, institutional protocol, and a surgeon's willingness to accept transfusion burden rather than delay an operation with an hourly mortality penalty. Delay is the wrong default.

On the root side, an Innovations piece on external aortic root support in the modern Ross procedure revisits the autograft's durability weak point. External support addresses late autograft dilatation, the single failure mode that has kept the Ross confined to high-volume centers despite the survival signal in young adults favoring it over mechanical and bioprosthetic AVR. A team at the Medical University of Vienna is also claiming a solution to a core problem in aortic valve treatment; no peer-reviewed data accompanies the press release, so treat it as such.


Valve Surgery

[NOTABLE] Hemoadsorption during endocarditis surgery produced the largest mortality signal in today's literature, and the design cannot support it. In 176 high-risk IE patients across 2020-2024, the hemoadsorption group had less vasoplegia (24.7% vs 49.4%), shorter ICU stay (7.8 vs 11.5 days), and 30-day mortality of 7.5% versus 20.5%, with a win ratio of 3.83. This is a non-randomized, unmatched comparison with sequential-era contamination, and the prior randomized record for cytokine adsorption in cardiac surgery (REMOVE, for one) has been negative. Enthusiasm here should be provisional.

Two mechanistic items frame mitral and aortic disease. An ex vivo porcine accelerated-life test found that PTFE at the papillary muscle head, the surgical reference, was matched only by a helical anchor in the same location; lateral wall and apical anchoring showed greater compliance and migration. That is a direct warning to transcatheter chordal systems built around apical fixation. And in 128 aortic stenosis patients versus 105 controls, a pro-inflammatory monocyte phenotype was most pronounced in those with concomitant ASCVD, supporting mechanistic heterogeneity in calcific valve disease rather than a single atherosclerosis-like pathway.


Transplant & Mechanical Circulatory Support

Durable LVAD outcomes in Japan improved substantially with HeartMate 3, and the residual failure modes are right-sided. The third J-MACS report, 1,859 patients from 2011 to 2025, shows 5-year survival of 84% in the post-2019 era versus 76% before, with significant gains in freedom from pump thrombosis, stroke, major bleeding, and pump exchange. Right ventricular failure and ventricular arrhythmia did not improve. Destination therapy recipients had 3-year survival of 81% versus 91% for bridge-to-transplant, a gap that reflects Japan's severely constrained donor pool and its late adoption of DT, not device performance.

Xenotransplantation moved from compassionate use toward trial. A Minerva Surgery review notes FDA clearance in May 2026 for EXPRESS, the first cardiac xenotransplant clinical trial, using a 10-gene-edited porcine heart, with antibody-mediated rejection still the dominant barrier and both Maryland cases ending in xenograft failure. Supporting that, human thrombomodulin expression on porcine endothelium reduced platelet adhesion and activation under shear flow to a degree comparable with activated protein C pretreatment. Biomarker-guided immunosuppression (donor-derived cell-free DNA, gene expression profiling, circulating microRNA) is the near-term way to attack the stagnant post-transplant median survival.


Arrhythmia Surgery

No new surgical ablation outcome data today, which makes the market the more informative signal. AtriCure trades near its 52-week high on trial-pipeline optimism rather than earnings, with forward P/E above 130. Surgical AF ablation still rests on CTSN and LAAOS III for its strongest randomized support, and nothing published today changes that. The systematic review of systematic reviews on BMI and perioperative outcomes found that across 332 primary studies in seven common operations including CABG, only 11.7% reported ethnicity and 2.4% reported socioeconomic status, with a weak signal that postoperative AF risk varies by both BMI and ethnicity. We cannot risk-stratify POAF by population characteristics we refuse to record.


Congenital Heart Surgery

[NOTABLE] Single-ventricle physiology, not pulmonary venous anatomy, drives death after TAPVC repair. Across 1,258 infants in the Pediatric Health Information System, 2015-2024, one-year survival was 52% in the 120 single-ventricle patients versus 88% in biventricular anatomy (HR 3.69; 6.62 for PA/IVS, 4.42 for HLHS), with 32% cumulative pulmonary vein reintervention at 12 months and five-fold higher costs ($1,019,390 vs $259,303). Administrative data cannot capture anatomic subtype or obstruction severity, but the magnitude is not a coding artifact. This cohort deserves its own risk model and its own consent conversation.

Redo pulmonary valve replacement after tetralogy repair via left anterior minithoracotomy versus resternotomy showed significantly lower vasoactive-inotropic scores and non-significant trends toward shorter operations and stays, but with N=38 and a sex imbalance, this is hypothesis-generating against a transcatheter PVR field that already owns much of this anatomy. Miniaturized CPB circuits in 3,196 pediatric cases improved intraoperative transfusion avoidance (47.9% vs 29.0%) but independently predicted higher ICU transfusion (OR 2.59), a tradeoff that is weight-dependent and should be chosen deliberately, not by default.


Surgery vs. Intervention

Transcatheter mitral programs are testing whether on-site surgery is still required, and the data are too thin to answer. A registry comparison of 64 M-TEER patients treated by the same interventional team at a center with and without on-site cardiac surgery found device and procedural success of 81.0% versus 72.1%, with zero surgical conversions and zero in-hospital deaths at both. Confidence intervals spanned 42 percentage points and non-inferiority was not established. Current ESC/EACTS and ACC/AHA valve guidance keeps structural intervention inside a Heart Team with surgical capability; 21 patients at one site does not relax that. Note also that 12 of 16 device-success failures were mean gradients at or above 5 mmHg, the failure mode surgical repair largely avoids.

On the coronary side ahead of valve intervention, Cardiovascular Business reports that staged PCI before TAVR remains the safer sequence in selected patients, the mirror image of the surgical question: in patients with significant multivessel disease and severe AS, SAVR plus CABG in one operation still removes the staging problem entirely.


Device & Technology

Cerebral oximetry finally has a pooled effect estimate, and it is narrower than its marketing. The British Journal of Anaesthesia meta-analysis of 17 RCTs, N=2,288, found NIRS-guided intraoperative management probably reduces early postoperative cognitive decline (RR 0.65, 95% CI 0.42-0.99) with no detectable effect on stroke, delirium, or mortality. Heterogeneity was 65%, the trials were small and single-center, desaturation thresholds and intervention algorithms varied, and no trial used validated quality-of-life measures. Buy the monitor if you want fewer early cognitive events. Do not claim a stroke benefit.

Pharmacologic neuroprotection got a second look: a multicenter randomized double-blind trial in 300 valve surgery patients reported POCD in 24/150 with ulinastatin versus 42/150 control, with lower MMP9 and S100β. MMSE is a blunt cognitive instrument and ulinastatin is not available in most Western markets. Elsewhere, a machine-learning model predicting intraoperative hypotension five minutes ahead reached AUROC 0.894 externally, though it was trained in non-cardiac surgery, and a narrative review of DEHP exposure during CPB confirms internal plasticizer exposure in every cohort studied without establishing clinical harm.


Regulatory & Policy

[NOTABLE] The failure mode behind the four-lot early alert on Edwards' Commander M delivery system for the SAPIEN M3 transcatheter mitral valve is specific and ugly: embolism, or an undeployable device that cannot be withdrawn through the guide sheath, in a population selected precisely because it cannot tolerate surgery. FDA's alert followed three reports of balloon burst during inflation, with one death and one serious injury. Bailout surgical mitral replacement in that cohort carries a prohibitive mortality. Edwards sent customer letters on October 5 recommending removal and return; other lots remain in use. Surgical teams covering TMVR programs should confirm lot numbers before the next case and review their emergency sternotomy pathway, because the alert quantifies exactly the scenario the Heart Team requirement exists for.

Separately, an expert analysis of the EACTS/STS/AATS guidelines on temporary mechanical circulatory support in adult cardiac surgery has been published for the cardiothoracic anesthesia and critical care audience, translating the joint recommendations into perioperative practice.


Industry & Market

Procedure volume is growing on the catheter side of the ledger, not the surgical side. Cardiovascular Business reports rising compensation, productivity, imaging volumes, and TAVR case counts for cardiologists. That is the referral environment surgical programs are operating in, and it is the economic context for the M-TEER networking question above: interventional capacity is expanding faster than surgical backup is being built. Leadership moves track the consolidation trend, with McLaren Health Care naming a system chief of cardiothoracic surgery across its network rather than per-hospital chiefs.

Centralization has an outcomes argument behind it. An NCDB analysis of 7,462 esophageal adenocarcinoma patients found that the survival penalty for living in a high-risk zip code disappeared at centers performing 10 or more esophagectomies annually (45.69% vs 46.20% five-year OS) while persisting at low-volume centers. The same volume-equity logic applies directly to congenital and aortic surgery.


Financial Analysis

The sharpest divergence in the sector right now is between a positive clinical signal and a collapsed equity. CytoSorbents, whose adsorption technology sits behind the intraoperative hemoadsorption literature, trades at $3.06 after a 74.9% six-month decline and a 52-week high of $18.40, even as a 176-patient endocarditis cohort reports a mortality difference most device companies would pay for. The market is pricing the design, not the point estimate: observational, unmatched, sequential-era, and preceded by negative randomized trials in cardiac surgery. The two analysts covering the name carry a $47.50 average target against a $3 stock, which tells you how little institutional attention remains.

Boston Scientific is down 30.4% over six months and sits at its 52-week low of $41.39, with the analyst target range ($44 to $94) wider than most sector disagreements get. Artivion is down 40.5% with an average target of $42.15, more than double the current $21.87, and no consensus recommendation. Both reflect de-rating of structural heart and aortic growth stories rather than any single trial readout. Running the other way: AtriCure has doubled in six months, Getinge is up 31.8% on perfusion and ICU demand, and LivaNova gained 3.18% on the day. Edwards, carrying today's FDA alert, still closed up 1.91% at $88.10, which means the market read the Commander M issue as four lots rather than a platform problem. That read is reasonable but not yet confirmed.


Cardiac Surgery Stocks

6-Month Cardiac Surgery Industry Stock Performance

Edwards Lifesciences (EW)

EW 6-Month Chart
  • Close $88.10, +$1.65 (+1.91%); six-month change +11.45%
  • Market cap $50.8B; P/E trailing 51.82, forward 26.04; beta 0.86; 52-week range $72.42 to $96.29
  • Analyst target $101.81 (range $84 to $110, 26 analysts); consensus buy
  • Next earnings November 4, 2026; EPS est $0.74, revenue est $1.68B

The stock rose the same day FDA flagged the Commander M mitral delivery balloon failures, which indicates investors are reading this as a lot-level manufacturing issue, not a SAPIEN M3 program risk. Watch the November 4 call for TMTT guidance; if M3 launch timing slips, the forward multiple has room to compress.

Medtronic (MDT)

MDT 6-Month Chart
  • Close $95.45, +$1.22 (+1.29%); six-month change +13.37%
  • Market cap $122.1B; P/E trailing 23.17, forward 14.89; beta 0.57; 52-week range $73.31 to $106.33
  • Analyst target $104.40 (range $85 to $121, 25 analysts); consensus buy
  • Next earnings November 17, 2026; EPS est $1.33, revenue est $9.48B

A forward P/E under 15 on a company with surgical valve, perfusion, and cardiac ablation franchises prices in near-zero growth. Volume of 50 million shares on a 1.3% move is the tell that this is index and rotation flow, not fundamental repricing.

Abbott (ABT)

ABT 6-Month Chart
  • Close $104.68, +$1.71 (+1.66%); six-month change +10.43%
  • Market cap $181.1B; P/E trailing 33.66, forward 17.26; beta 0.58; 52-week range $81.97 to $132.03
  • Analyst target $120.72 (range $103 to $135, 26 analysts); consensus strong buy
  • Next earnings October 21, 2026; EPS est $1.41, revenue est $12.99B

The only strong-buy consensus among the large caps here, and the lowest analyst target floor relative to spot ($103 versus $104.68), meaning no covering analyst sees meaningful downside. HeartMate 3 durability data from J-MACS supports the MCS franchise directly.

Boston Scientific (BSX)

BSX 6-Month Chart
  • Close $44.14, +$1.14 (+2.65%); six-month change -30.40%
  • Market cap $64.0B; P/E trailing 18.02, forward 13.07; beta 0.57; 52-week range $41.39 to $105.65
  • Analyst target $59.24 (range $44 to $94, 29 analysts); consensus buy
  • Next earnings October 28, 2026; EPS est $0.74, revenue est $5.09B

Trading within 7% of its 52-week low after a halving from the high, with a $50 spread between the lowest and highest analyst target. October 28 is the clearing event; the structural heart and electrophysiology lines carry the thesis.

AtriCure (ATRC)

ATRC 6-Month Chart
  • Close $57.78, +$0.48 (+0.84%); six-month change +100.07%
  • Market cap $2.9B; P/E trailing 275.14, forward 133.14; beta 1.25; 52-week range $25.36 to $61.70
  • Analyst target $55.78 (range $36 to $65, 9 analysts); consensus buy
  • Next earnings November 3, 2026; EPS est $0.01, revenue est $0.15B

The stock has doubled in six months and now trades above the average analyst target, which is unusual and means the sell side is behind the move. Valuation rests on trial progress, not current earnings, at a penny of quarterly EPS.

Artivion (AORT)

AORT 6-Month Chart
  • Close $21.87, +$0.34 (+1.58%); six-month change -40.47%
  • Market cap $1.1B; forward P/E 29.23; beta 1.22; 52-week range $19.16 to $48.25
  • Analyst target $42.15 (range $38 to $48, 8 analysts); no consensus recommendation
  • Next earnings November 5, 2026; EPS est $0.07, revenue est $0.12B

The widest gap in this list between price and target: eight analysts hold a $42.15 average against a $21.87 stock, with no formal recommendation consensus. Aortic graft and On-X valve demand has not deteriorated, so the de-rating is sentiment and balance sheet driven.

TransMedics (TMDX)

TMDX 6-Month Chart
  • Close $76.52, +$1.00 (+1.32%); six-month change -29.88%
  • Market cap $2.7B; P/E trailing 20.79, forward 33.95; beta 1.93; 52-week range $60.10 to $156.00
  • Analyst target $98.73 (range $65 to $125, 11 analysts); consensus buy
  • Next earnings October 29, 2026; EPS est $0.29, revenue est $0.18B

Beta of 1.93 makes this the most volatile name in the group, and the stock is down more than half from its 52-week high. The clinical tailwind is real: today's ECPR-to-DCD-transplant case report is the exact pathway OCS perfusion was built to enable.

LivaNova (LIVN)

LIVN 6-Month Chart
  • Close $78.50, +$2.42 (+3.18%); six-month change +20.75%
  • Market cap $4.3B; P/E trailing 23.29, forward 16.76; beta 0.88; 52-week range $48.82 to $85.76
  • Analyst target $90.55 (range $75 to $105, 11 analysts); consensus buy
  • Next earnings November 4, 2026; EPS est $1.06, revenue est $0.38B

Best single-day performer in the group. The cardiopulmonary franchise (oxygenators, heart-lung machines, autotransfusion) benefits from any shift away from ANH toward cell salvage, which is the practical read of the ANH female subgroup analysis.

Johnson & Johnson / Abiomed (JNJ)

JNJ 6-Month Chart
  • Close $253.28, -$0.63 (-0.25%); six-month change +9.15%
  • Market cap $610.4B; P/E trailing 28.75, forward 21.59; beta 0.21; 52-week range $184.66 to $281.07
  • Analyst target $278.86 (range $190 to $320, 22 analysts); consensus buy
  • Most recent earnings October 13, 2026; EPS est $2.92, revenue est $26.46B

The only decliner on the day, and the lowest beta in the group at 0.21. Abiomed is a rounding error inside a $610B pharma, but Impella volume tracks directly with the ECPELLA and LV unloading literature, including today's porcine hypothermia plus mechanical unloading study.

United Therapeutics (UTHR)

UTHR 6-Month Chart
  • Close $541.51, +$1.48 (+0.27%); six-month change -6.72%
  • Market cap $23.2B; P/E trailing 19.42, forward 16.03; beta 0.49; 52-week range $409.07 to $609.35
  • Analyst target $656.93 (range $368 to $728, 14 analysts); consensus buy
  • Next earnings October 28, 2026; EPS est $6.36, revenue est $0.78B

The xenotransplant optionality here is priced at near zero against the pulmonary hypertension base business. FDA clearance of the EXPRESS cardiac xenotransplant trial in May 2026 validates the regulatory pathway for the whole gene-edited organ field.

CytoSorbents (CTSO)

CTSO 6-Month Chart
  • Close $3.06, -$0.03 (-0.97%); six-month change -74.92%
  • Market cap under $0.1B; beta 1.37; 52-week range $2.84 to $18.40
  • Analyst target $47.50 (range $15 to $80, 2 analysts); no consensus recommendation
  • Next earnings November 12, 2026; revenue est $0.01B

Volume of 10,699 shares is a liquidity warning, and the $47.50 average target against a $3.06 price is a stale-coverage artifact. Today's endocarditis hemoadsorption cohort is clinically encouraging and commercially irrelevant until a randomized trial confirms it.

Getinge (GETI-B.ST)

GETI-B.ST 6-Month Chart
  • Close SEK 256.80, +2.50 (+0.98%); six-month change +31.78%
  • Market cap SEK 70.6B; P/E trailing 26.10, forward 23.69; beta 0.82; 52-week range SEK 175.90 to 259.70
  • Analyst target SEK 253.82 (range 165 to 300, 11 analysts); consensus buy
  • Next earnings October 21, 2026; EPS est SEK 2.57, revenue est SEK 8.49B

Best six-month performer among the large-cap names and trading within 1% of its 52-week high, now slightly above average target. Cardiopulmonary bypass consoles, ECMO consoles, and intra-aortic balloon pumps all benefit from rising ECPR utilization.

Terumo (4543.T)

4543.T 6-Month Chart
  • Close JPY 2,302.50, +48.00 (+2.13%); six-month change +6.12%
  • Market cap JPY 3,396.4B; P/E trailing 20.22, forward 22.61; beta 0.31; 52-week range JPY 1,900 to 2,689
  • Analyst target JPY 3,027.69 (range 2,600 to 3,600, 13 analysts); consensus strong buy
  • Next earnings November 12, 2026; revenue est JPY 308.85B

Strong buy consensus with 31% implied upside and the lowest-but-one beta in the group. Terumo's oxygenator and vascular graft lines are directly exposed to the DEHP-free tubing question, which is a materials cost headwind if regulators move.

XVIVO Perfusion (XVIVO.ST)

XVIVO.ST 6-Month Chart
  • Close SEK 219.40, +2.20 (+1.01%); six-month change -24.14%
  • Market cap SEK 7.1B; P/E trailing 79.02, forward 38.38; beta 1.47; 52-week range SEK 160.10 to 314.80
  • Analyst target SEK 321.60 (range 260 to 385, 5 analysts); consensus strong buy
  • Next earnings October 22, 2026; EPS est SEK 0.72, revenue est SEK 0.23B

Sitting at its six-month low with a strong buy consensus and 47% implied upside, the sharpest disagreement between price and coverage in the group. Heart preservation volume growth depends on DCD heart adoption, which today's literature continues to support.

Market outlook. The sector split cleanly today: everything with perfusion, ECMO, or transplant exposure traded up, while the structural heart growth names (Boston Scientific, Artivion) remain near 52-week lows. That is consistent with what the evidence base is actually producing. Perioperative support and organ preservation keep generating positive signals, while transcatheter platforms are absorbing durability questions and, in Edwards' case, a delivery system safety alert. Private players (Corcym, BiVACOR, eGenesis, Berlin Heart) have no public marks, but BiVACOR and eGenesis sit squarely in the two areas where clinical momentum is clearest: total artificial heart bridging and gene-edited xenografts. Earnings season starting with Abbott on October 21 will test whether procedure volume growth is reaching surgical product lines or stopping at the cath lab.


Clinical Trial Updates

Coronary

  • [LANDMARK] NCT07871591: TOP-CABG Trial Follow-up Extension (TOP-CABG FE). Not yet recruiting, N/A phase, enrollment 2,290, sponsor China National Center for Cardiovascular Diseases. Updated October 13. TOP-CABG is one of the largest randomized CABG trials ever run outside North America and Europe; the extension converts a short-horizon result into graft patency and survival data at a timescale where arterial versus venous conduit differences actually emerge. For a field whose multiple arterial grafting debate still rests largely on ART and observational series, this is the follow-up that matters.
  • NCT07871201: Dynamic Arterial Elastance for Prediction of Vasopressor Requirement After Anesthesia Induction in Elective On-Pump CABG. Recruiting, N/A phase, enrollment 42, sponsor Elzem Sen. Updated October 13.

General Cardiac Surgery and Perioperative Care

  • NCT07872982: BrainProtect-guided real-time cerebral autoregulation monitoring during CPB. Not yet recruiting, phase NA, enrollment 304, sponsor Scienceforbrain UAB. Updated October 14. Directly tests whether autoregulation-targeted pressure management outperforms the NIRS threshold approach that today's BJA meta-analysis found only moderately supported.
  • NCT07871188: Intraoperative pulse pressure variation and postoperative lactate clearance in cardiac surgery. Recruiting, N/A phase, enrollment 100, sponsor Elzem Sen. Updated October 13.
  • NCT07632027: Bedside Assessment of Right Ventricular Output Lying in Prone or Supine. Not yet recruiting, phase NA, enrollment 70, sponsor Sahlgrenska University Hospital. Updated October 13.

Congenital

  • NCT07486167: Lung Volume Optimization Maneuver and Cardiac Output in Ventilated Children With CHD Undergoing Surgical Repair. Not yet recruiting, phase 1/2, enrollment 80, sponsor Charité Universitätsmedizin Berlin. Updated October 15. PEEP titration against cardiac output in a population where the heart-lung interaction is the whole problem.
  • NCT07837024: TORCH-LATAM-003, Regional Advanced-Therapy Pathways for Congenital Heart Disease. Not yet recruiting, phase NA, enrollment 360, sponsor CardioVision International Tech. Updated October 13.

Transplant & MCS

  • NCT07799272: TORCH-LATAM, A Regional Pathway to Improve Transplant Evaluation for Congenital Heart Disease. Not yet recruiting, phase NA, enrollment 600, sponsor CardioVision International Tech. Updated October 13. Access-pathway trials rarely get funded; this one targets the referral bottleneck that precedes every listing decision in Latin America.

Social & Conference Highlights

The Congenital Heart Surgeons' Society Center for Research and Quality published its 2025 annual report from the Fall Work Weekend held in Chicago, covering ongoing inception-cohort studies and the society's adaptation to changing clinical research regulation. CHSS inception cohorts remain the most reliable long-horizon data source in congenital surgery precisely because they enroll at diagnosis rather than at operation, which removes the selection bias that corrupts most registry comparisons. On the workforce side, CTSNet continues to list open cardiothoracic positions, and lay coverage of mechanical support keeps improving, with the Herald Sun profiling a continuous-flow LVAD recipient living without a pulse. Also published: a survey of 43 centers across 21 Central and South-Eastern European countries finding formal ACHD transition programs in only 23%, with nurses and psychosocial staff involved in just 20%.


The next move belongs to the ANH investigators. A trial that was neutral overall and harmful in its female subgroup needs either a prespecified replication in women or a quiet retirement of the technique, and the burden now sits with the groups that built blood-conservation protocols around it. Watch November earnings for whether the structural heart de-rating is a demand problem or a multiple problem, and watch the FDA page for the Commander M alert.

Tomorrow’s issue, every weekday morning.

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