Introduction: the unmet need in the shadow of established dogma
For years transcatheter aortic valve implantation (TAVI) has been governed by a foundational principle: procedures must be performed in comprehensive Heart Valve Centers with both cardiology and cardiac surgery (CS) departments on site [1–3]. This dogma, enshrined in the 2021 European Society of Cardiology and European Association for Cardio-Thoracic Surgery guidelines, emerged from prudent caution during the nascent stages of this complex, transformative therapy [1]. While this standard has undoubtedly fostered safety and excellence, it has also created an unintended yet increasingly critical consequence: a crisis of access to care. The clinical burden of severe aortic stenosis (AS) is immense and growing. As the most common valvular disease in industrialized nations, it affects approximately 5% of adults over 65 years of age [4]. Once symptomatic, severe AS carries a grim prognosis, with only 50% of patients surviving 2 years without treatment. This reality is particularly stark in Poland, where a well-developed network of 158 catheterization laboratories contrasts sharply with just 29 TAVI centers offering on-site CS [5, 6]. This infrastructural mismatch creates a profound logistical bottleneck. Despite national initiatives like “Valve for Life”, Poland’s TAVI penetration rate falls far short of estimated clinical need [7–10]. The direct result is prolonged waiting lists – a factor independently associated with increased mortality, heart failure hospitalizations, and deteriorating functional capacity [11]. Paradoxically, the very model designed to maximize safety now causes harm by creating systemic barriers to timely, life-saving treatment. This tension demands a re-evaluation of the established paradigm, shifting the question from whether TAVI can be performed without on-site CS to how it can be done safely [12].
The global experience: a wave of reassuring evidence
Over the past decade, large-scale international registries have generated substantial data consistently demonstrating the safety and feasibility of performing TAVI in centers without on-site CS [13–18]. This evidence challenges the long-held assumption that an in-house surgical department is an absolute prerequisite for good outcomes in appropriately selected patients. The German TAVI Registry provides one of the most robust datasets [13]. In an early analysis of 1,432 patients, 12% underwent treatment in centers without on-site CS. While these centers treated a more hemodynamically stable cohort – suggesting careful patient selection – their outcomes were comparable to those of surgical centers. The 30-day mortality was 6.2% in non-CS centers versus 8.3% in CS centers, and one-year mortality was 17.4% versus 20.4%, respectively, with no statistically significant differences (Table I). A subsequent analysis based on the data from AQUA Registry revealed similar in-hospital mortality rates of 3.8% in non-CS centers compared to 4.2% in CS centers [14]. A matched-pair analysis of 550 patient pairs further confirmed no significant differences in intraprocedural complications or in-hospital death (Table I). More recent prospective studies, including a multicenter trial in Israel [15], have shown excellent outcomes, with no in-hospital mortality and no need for urgent surgery in 149 consecutive patients treated in a center with remote surgical backup agreements.
Table I
Comparative outcomes from major international registries
| Study | Country | Patients (No-CS vs. CS) | Vascular complications (No-CS vs. CS) | 30-day mortality (No-CS vs. CS) | 1-year mortality (No-CS vs. CS) | Emergent cardiac surgery (No-CS vs. CS) |
|---|---|---|---|---|---|---|
| Eggebrecht et al. [13] | Germany | 178 vs. 1,254 | 18.5% vs. 22.2% (p = NS) | 6.2% vs. 8.3% (p = NS) | 17.4% vs. 20.4% (p = NS) | 2.2% vs. 1.6% (p = NS) |
| AQUA Registry/Eggebrecht et al. [14] | Germany | 550 vs. 550 (matched-pair) | 7.0% vs. 8.3% (p = 0.43) | In-hospital: 1.8% vs. 2.9% (p = 0.23) | Not reported | Not reported |
| Egger et al. [17] | Austria | 290 vs. 290 (matched-pair) | Major bleed: 9.3% vs. 4.8% (p = 0.05) | 6.9% vs. 6.2% (p = 0.72) | 19.1% vs. 16.6% (p = 0.40) | Not reported |
| Roa Garrido et al. [18] | Spain | 384 (No-CS only) | Not reported | 6.1% | 12.2% | 0.3% |
| Gafoor et al. [16] | Germany | 97 (No-CS only) | 16.5% | 3.1% | Not reported | 0% |
| Barashi et al. [15] | Israel | 149 (No-CS only) | 0.67% | 0.67% | Cardiac: 0.67% | 0% |
This growing body of evidence reflects the remarkable maturation of TAVI technology and procedural technique. The risk of catastrophic complications requiring emergent CS – the primary justification for on-site backup – has plummeted from over 2% in the early era to well below 1%, and often less than 0.5%, in contemporary practice [19, 20]. This decline is attributable to superior pre-procedural imaging with computed tomography, refined patient selection, smaller and more deliverable valve systems, and greater operator expertise.
The data reveal what can be termed the “surgical backup paradox”. While the rate of emergent CS has become exceedingly low, outcomes when it is needed remain devastatingly poor, with mortality rates approaching 50% regardless of whether surgery is performed on site [19–22]. The German TAVI registry reported 50% mortality after emergent CS in non-CS centers versus 45% in CS centers – statistically and clinically similar catastrophic outcomes [13, 19]. This suggests that for these rare events, patients are already in profound physiological collapse where proximity to an operating room does not guarantee survival. The focus must therefore shift from ensuring proximity to prioritizing prevention through meticulous patient selection and procedural execution, coupled with robust, pre-planned systems for managing rare complications.
The momentum behind this paradigm shift continues to build through dedicated prospective investigations. Italy’s “TAVI at Home” registry exemplifies this trend – a multicenter prospective study specifically designed to evaluate TAVI safety and feasibility in non-CS centers, with 30-day all-cause mortality as its primary endpoint [23]. Even more compelling is the forthcoming TRACS trial, which represents a pivotal advance in generating definitive evidence [24]. This prospective, randomized, multicenter study will enroll 566 patients to test the non-inferiority of TAVI performed without on-site CS backup versus traditional surgical centers. TRACS’s comprehensive primary endpoint – a composite of all-cause mortality, stroke, and cardiovascular readmission at 1 year – will provide the high-level randomized evidence needed to definitively guide future TAVI service delivery models. These systematic investigations signal the field’s evolution from observational reassurance to prospective validation of this transformative care model.
A Polish precedent: lessons from balloon aortic valvuloplasty
In this issue of the Advances in Interventional Cardiology, the multicenter registry comparing balloon aortic valvuloplasty (BAV) in standalone catheterization laboratories versus units with on-site CS backup offers compelling, locally sourced evidence directly relevant to this debate [25]. While BAV is now largely a palliative or bridging therapy, it remains a high-risk structural heart intervention involving manipulation of heavily calcified aortic valves, carrying risks of annular injury, severe aortic regurgitation, and hemodynamic collapse analogous to those in TAVI [26]. The findings from this Polish registry are striking. The study compared 138 BAV procedures in standalone catheterization laboratories with 376 in on-site CS [25]. Critically, patients treated in standalone catheterization laboratories represented a higher-risk population, with significantly greater prevalence of coronary artery disease (63% vs. 45%), anemia (47% vs. 12%), and arterial hypertension (84% vs. 64%). Despite this more challenging baseline profile, there were no significant differences in major adverse events. In fact, in-hospital death was numerically lower in the standalone catheterization laboratories group (0.72% vs. 2.93%, p = 0.14). Rates of cardiac tamponade, significant bleeding requiring transfusion, and need for permanent pacemaker implantation were statistically indistinguishable between the two settings. Furthermore, both groups achieved significant and comparable hemodynamic improvement, confirming procedural efficacy.
This study represents more than an interesting observation; it directly demonstrates system capability within the Polish healthcare context [25, 26]. It provides powerful proof of concept that the necessary “soft infrastructure” – including operator skill, nursing care, peri-procedural monitoring, and protocols for managing complications – already exists at a very high level in select non-CS centers. The ability to safely manage a sicker patient cohort through complex structural procedures implies that institutional readiness for carefully implemented TAVI programs already exists. Therefore, the progression from performing high-risk BAV to performing meticulously selected TAVI procedures is not a leap into the unknown, but a logical, incremental step built upon a proven foundation of local expertise.
The blueprint for a safe program: from “If” to “How”
Expanding TAVI access cannot come at the expense of patient safety [1–3]. Establishing a successful TAVI program in a center without on-site CS is not a “TAVI-lite” model; it is a highly structured, protocol-driven system that must be built on four non-negotiable pillars.
Pillar 1: The integrated Heart Team – The multidisciplinary Heart Team is the cornerstone of modern valvular care [1–3]. In a non-surgical setting, this cannot be an informal arrangement. It requires formal, functional partnership between the “spoke” interventional center and a designated “hub” surgical center. This must include mandated joint case reviews, shared patient selection criteria, and a unified philosophy of care to prevent decision-making bias and ensure that every patient receives the most appropriate therapy. Modern teleconferencing technology makes such remote collaboration entirely feasible.
Pillar 2: Rigorous patient selection – New programs must begin with careful selection of patients presenting the lowest procedural risk. This means prioritizing patients with favorable anatomy for straightforward transfemoral approaches, including those with adequate coronary ostia height, minimal calcification of the left ventricular outflow tract, and suitable peripheral vasculature. This strategy of “starting simple” most effectively minimizes the risk of feared complications, such as coronary obstruction or annular rupture, during the program’s learning curve.
Pillar 3: The on-demand surgical safety net – This represents a critical and pragmatic compromise. While a permanent on-site surgical department may be absent, surgical expertise must be immediately available. We strongly advocate for mandatory temporary on-site presence of both cardiac and vascular surgeons [27]. This model, utilized in some German centers, provides an immediate expert safety net, fulfilling the spirit of the guidelines while remaining logistically achievable [13, 14]. It involves having surgeons scrubbed-out and present in the control room, ready to intervene instantly, rather than merely on call.
Pillar 4: Formalized rescue protocols – Pre-defined, written, and regularly drilled protocols must exist for managing both cardiac and vascular complications requiring surgical intervention [1–3]. This includes formal, legally binding transfer agreements with the surgical hub, dedicated transfer teams on standby, and clear criteria for activating transfers. The success of the Israeli program was predicated on precisely such collaboration with remote surgical centers. The objective is to make the transfer process so efficient and seamless that it minimizes time delays compared to in-house transfers from catheterization laboratories to operating rooms.
This four-pillar model does more than ensure safety; it creates a new form of networked quality control. By requiring visiting surgeons from established hubs to be physically present, it fosters natural proctorship and mentorship relationships. This ensures that techniques and complication management strategies of new centers align with best practices from experienced hubs, actively disseminating expertise and raising standards of care across the entire network.
Conclusion: a measured and confident step forward for Polish cardiology
The evidence is compelling, the local precedent is strong, and the clinical need is undeniable [12–18]. The time has come for Polish cardiology to move beyond debate and begin careful, strategic implementation of TAVI programs in select, high-volume interventional centers lacking on-site CS. International registry data demonstrate that with proper patient selection and experienced operators, outcomes are not compromised. The commented BAV paper [25] provides powerful local validation of the skill and readiness already existing within Poland’s non-surgical centers.
This is not a call for deregulation, but for adoption of a new, highly regulated model built on the pillars of integrated Heart Teams, rigorous patient selection, on-demand surgical safety nets, and formalized rescue protocols. The answer to our title question is a qualified but confident “yes”. This is a patient-centric imperative. By leveraging its extensive network of skilled catheterization laboratories within a structured framework of surgical collaboration, Poland has a unique opportunity to resolve critical access-to-care bottlenecks and provide timely, life-saving therapy to thousands of citizens currently waiting.
