Highlights
- •
Many patients fail to undergo intervention transcatheter mitral valve intervention.
- •
Even at a large, tertiary center, 62% of referred patients are treated medically.
- •
Exclusion reasons include clinical (38.5%) and patient preference (38.8%).
- •
Clinical trials testing new transcatheter mitral valve repair (TMVr) devices should report reasons for screen failure.
Despite an expanding armamentarium of devices, many patients with mitral regurgitation referred for transcatheter mitral valve repair (TMVr) or replacement (TMVR) do not meet strict clinical trial inclusion and exclusion criteria. We sought to understand the rates that patients were excluded from transcatheter mitral valve therapies and reasons why. We retrospectively analyzed the medical charts and correspondence related to patients referred to our tertiary valve center for TMVr or TMVR between June 2016 and September 2019. Patients were screened for eligibility by our structural Heart Team for either TMVr or TMVR. If TMVr or TMVR was not offered, the reason for screen failure was recorded and categorized. Over the 3-year period, 564 patients were referred for TMVr and orTMVR. Out of these, 15.9% were determined to be eligible for, and underwent, surgical repair or replacement. Ninety-two patients (16.3%) underwent TMVr or TMVR. The majority of patients (343 of 564, 60.8%) ultimately did not undergo intervention. The primary reason for exclusion was clinical in 38.5%, issues related to patient preference of care delivery in 38.8%, anatomical in 13.7%, and futility in 9.0%. In contemporary real-world practice, the majority of patients with mitral regurgitation referred for transcatheter therapies are excluded. Clinical trials testing new transcatheter devices should be encouraged to record and report reasons for screen failure and follow these patients to better understand optimal timing of intervention, address challenging anatomies, and, ultimately, improve penetrance of these novel therapies.
Mitral regurgitation remains highly prevalent in developed countries, with mortality rates close to 50% at 5 years in patients left untreated. , Despite this, up to half of the patients referred for open surgical repair and orreplacement ultimately do not undergo surgery because of procedural risk. Catheter-based techniques such as transcatheter mitral valve repair (TMVr) or transcatheter mitral valve replacement (TMVR) are potential alternatives in these high-risk patients, but anecdotally, many are excluded from therapy. Recent analyses have shown screen failure rates of up to 89% in patients considered for TMVR, with high rates of cardiac death (12%) in those who did not undergo intervention. Both commercial and investigational devices are subject to stringent anatomic and clinical inclusion and orexclusion criteria. Even at centers enrolling in multiple clinical trials with a variety of available transcatheter devices, the penetrance of therapy remains low. , In this study, we sought to identify and categorize the reasons that patients referred to our center were denied therapy. In doing so, we sought to provide a more detailed understanding of how to broaden and improve the delivery of transcatheter mitral therapies.
Methods
All available data were collected and retrospectively analyzed on patients referred to our tertiary center for transcatheter mitral therapy between June 2016 and September 2019. The study design was approved by the Institutional Review Board (IRB). All correspondence with referring physicians, discussions with patients, submissions to clinical trial screening committees, and discussions among our institutional Heart Team were tracked in a secure online patient-tracking system. In patients who attended our center for an evaluation, the typical workflow included a standard clinical assessment with a member of the interventional cardiology team, a transesophageal echocardiogram ± gated computed tomographic chest imaging ± cardiac catheterization, where indicated. Patients were screened for eligibility for ongoing mitral trials by a research nurse coordinator, an echocardiographer, an interventional cardiologist, and a cardiothoracic surgeon. If deemed suitable by the local multidisciplinary Heart Team, patients were either referred for enrollment into an active clinical trial, where they would either screen in or screen out, treated with a commercially available device, or referred for mitral valve surgery. If patients were unsuitable, they continued with guideline-directed medical therapy under the care of their referring cardiologists. Clinical outcomes, when available, were recorded.
TMVr devices that were available during the period studied included: MitraClip (Abbott, Santa Clara, CA), NeoChord (NeoChord Inc., St. Louis Park, MN), the Transcatheter Mitral Cerclage Annuloplasty (Transmural Systems, Boston, MA) and PASCAL TMVr (Edwards Lifesciences, Irvine, CA). TMVR devices that were available during the study period included: Tendyne TMVR (Abbott), Caisson TMVR (LivaNova, Minneapolis, MN), Intrepid TMVR (Medtronic, Minneapolis, MN), Alta Valve TMVR (4C Medical Systems, Minneapolis, MN) and Valve-in-Valve Sapien 3 (Edwards Lifesciences).
In patients who were ultimately deemed unsuitable for any transcatheter mitral valve therapy, the reasons for exclusion were categorized according to the definitions provided in Table 1 . For cases in which more than one reason for exclusion applied, the primary reason for exclusion was identified, and other reasons were categorized as secondary.
| Exclusion Criteria | Definition |
|---|---|
| Anatomic or procedural impediment | |
| Prior valve treatment | Prior mitral valve repair/replacement. |
| Severe MAC | Moderate or moderate/severe MAC or location of MAC is deemed to be prohibitive to device deployment by local Heart Team |
| LVOT obstruction risk | Simulated neo-LVOT of < 200mm 2 |
| Mitral annulus too small or too large | Small: Mitral orifice area < 4.0 cm 2. Large: Outside of upper limit of IFU for transcatheter valves. |
| Mitral stenosis | Moderate or severe mitral stenosis, as defined by valve area < 1.5 cm 2 |
| TEE not possible | Due to procedural or anatomic reasons |
| Insufficient coaptation or leaflet length | < 10 mm coaptation of anterior and posterior leaflet or posterior leaflet < 8 mm. |
| Commissural jet | Presence of 1 or more significant jet at the medial or lateral commissure |
| Concomitant Procedure | Need for additional surgery at the time of surgical repair/replacement (e.g., CABG, SAVR) |
| Unsuitable access | Peripheral arterial or venous anatomy that precludes device delivery (e.g., interrupted IVC, IVC filter) |
| Clinical exclusion | |
| Severe TR | As reported by site (generally with TR velocities >2.8m/sec, dense color jet and hepatic vein reversal of flow during systole) |
| Pulmonary hypertension | PASP >70mmHG, as assessed by echo or cath. |
| Mild symptoms | NYHA class I or deemed to not be lifestyle limiting |
| Low EF/Low output/On inotrope’s | EF <25% within 90 days, current use of inotropes or mechanical circulatory support |
| Dilated ventricle | Left ventricular end-systolic dimension > 70 mm |
| CAD | The burden of CAD is deemed to be the driver of symptoms rather than the severity of mitral regurgitation |
| LVAD | Patient has a pre-existing LVAD in place |
| Requires revascularization | The mechanism of mitral regurgitation is thought to arise from obstructive CAD and potentially reversible with revascularization |
| Titration or continued GDMT | Patient on none/minimal therapy with room for further titration. Referring provider wishes to pursue medical therapy (including cardiac resynchronization therapy) |
| MR not severe | As determined by TEE performed by local Heart Team |
| Severe RV dysfunction | As determined by TEE performed by local Heart Team |
| Futility | |
| Frailty | Concurrent medical conditions with life expectancy < 12months or overall frailty deemed to be prohibitive by local Heart Team |
| Dementia | Degree of dementia would preclude any meaningful improvement in quality of life as determined by local Heart Team or based on the wishes of the pat |
| Severe COPD | Severe obstructive lung disease defined as FEV1 less than 50% predicted for age or predominant driver of symptoms is thought to arise more from pulmonary disease |
| Hemodialysis | Patient currently receiving any form or renal replacement therapy (HD, CVVH, ultrafiltration or peritoneal dialysis. |
| Malignancy | Current malignancy conferring a life-expectancy of less than 1 year. |
| Severe CKD | eGFR < 30 |
| Cirrhosis | MELD score > 12 or undergoing evaluation for liver transplantation. |
| Concerns regarding compliance or follow up | A history of unwillingness or inability to follow medical advice or current substance abuse that would inhibit follow up. |
| Patient preference or care delivery | |
| Insurance issues | Patient insurance not accepted or not approved. |
| No show | Patients failed to attend for scheduled evaluation |
| Seeking second opinion | Second opinion elsewhere or implanted at another site |
| Patient/family declined invasive procedures | Patient/family declined |
| Incomplete referral | Demographic information not provided by the referring hospital/physician |
| Loss of follow-up | Inability to contact/no response from the patient/family |
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
